UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
(Mark One)
REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 |
OR
ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the fiscal year ended
OR
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
OR
SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
Date of event requiring this shell company report
Commission File Number
(Exact name of registrant as specified in its charter and translation of registrant’s name into English)
(Jurisdiction of incorporation or organization)
(Address of principal executive offices)
Chief Executive Officer, Addex Therapeutics Ltd,
Tel:
(Name, Telephone, E-mail and/or Facsimile number and Address of Company Contact Person)
Securities registered or to be registered pursuant to Section 12(b) of the Act.
Title of each class Trading Symbol Name of each exchange on which registered | ||||
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| The | ||
each representing 120 ordinary shares, | ||||
CHF 0.01 per share | ||||
* Not for trading, but only in connection with the registration of the American Depositary Shares.
Securities registered or to be registered pursuant to Section 12(g) of the Act. None
Securities for which there is a reporting obligation pursuant to Section 15(d) of the Act. None
Indicate the number of outstanding shares of each of the issuer’s classes of capital or common stock as of the close of the period covered by the Annual Report.
Shares, par value CHF 0.01 per share:
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. ☐ Yes ☒
If this report is an annual or transition report, indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934. ☐ Yes ☒
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. ☒
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). ☒
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer ☐ | Accelerated filer ☐ | Emerging growth company |
If an emerging growth company that prepares its financial statements in accordance with U.S. GAAP, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
† | The term “new or revised financial accounting standard” refers to any update issued by the Financial Accounting Standards Board to its Accounting Standards Codification after April 5, 2012. |
Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report.
If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued financial statements.
Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b). ☐
Indicate by check mark which basis of accounting the registrant has used to prepare the financial statements included in this filing:
U.S. GAAP ☐ |
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| Other ☐ | |
by the International Accounting Standards Board ☒ |
If “Other” has been checked in response to the previous question, indicate by check mark which financial statement item the registrant has elected to follow. ☐ Item 17 ☐ Item 18
If this is an Annual Report, indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). ☐ Yes
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INTRODUCTION
Unless otherwise indicated or the context otherwise requires, all references in this Annual Report on Form 20-F to the terms “Addex,” “Addex Therapeutics,” “Addex Therapeutics Ltd,” “the company,” the “Addex Group,” the “Group”, “we,” “us” and “our” refer to Addex Therapeutics Ltd together with its subsidiaries.
We own trademarks for Addex Pharmaceuticals in Switzerland. All other trade names, trademarks and service marks of other companies appearing in this Annual Report on Form 20-F are the property of their respective holders. Solely for convenience, the trademarks and trade names in this Annual Report on Form 20-F may be referred to without the ® and ™ symbols, but such references should not be construed as any indicator that their respective owners will not assert, to the fullest extent under applicable law, their rights thereto. We do not intend to use or display other companies’ trademarks and trade names to imply a relationship with, or endorsement or sponsorship of us by, any other companies.
Our ADSs are traded on the Nasdaq Capital Market, or Nasdaq, under the symbol “ADXN”. Effective October 23, 2023, the ratio of ordinary shares per ADS was changed to one hundred and twenty shares per ADS. From January 29, 2020 to October 22, 2023, the ADSs traded on Nasdaq with a ratio of six shares per ADS. Unless indicated or the context otherwise requires, all per ADS amounts and numbers of ADSs in this Annual Report on Form 20-F have been retrospectively adjusted for the ADS Ratio Change.
Our reporting currency is the Swiss franc. The exchange rate between the Swiss franc and the U.S. dollar as of May 12, 2025 was USD 1.18 per CHF 1.0. We present our consolidated financial statements in accordance with IFRS Accounting Standards as issued by the International Accounting Standards Board (IFRS Accounting Standards). Readers of this Annual Report on Form 20-F should note that there may be certain differences between the presentation of our financial position, results of operations and cash flows under IFRS and U.S. generally accepted accounting principles.
The terms “dollar,” “USD” or “$” refer to U.S. dollars and the terms “Swiss francs” or “CHF” refer to the legal currency of Switzerland.
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SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Annual Report on Form 20-F contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that are based on our management’s beliefs and assumptions and on information currently available to our management. All statements other than present and historical facts and conditions contained in this Annual Report on Form 20-F, including statements regarding our future results of operations and financial positions, business strategy, plans and our objectives for future operations, are forward-looking statements. When used in this Annual Report on Form 20-F, the words “anticipate,” “believe,” “continue” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “ongoing,” “objective,” “plan,” “potential,” “predict,” “should,” “will” and “would,” or the negative of these and similar expressions identify forward-looking statements. Forward-looking statements include, but are not limited to, statements about:
| ● | the development of our drug candidates, including statements regarding the timing of initiation, completion and the outcome of pre-clinical studies or clinical trials and related preparatory work, the period during which the results of the studies or trials will become available and our research and development programs with respect to our drug candidates; |
| ● | the impact of global macroeconomic conditions, including pandemics, inflation, interest rates, trade policies (including tariffs) and geopolitical risks, on our business and operations; |
| ● | our ability to obtain and maintain regulatory approval of our drug candidates in the indications for which we plan to develop them, and any related restrictions, limitations or warnings in the label of an approved drug or therapy; |
| ● | our plans to collaborate, or statements regarding the ongoing collaborations, with partner companies; |
| ● | our plans to research, develop, manufacture and commercialize our drug candidates; |
| ● | the timing of our regulatory filings for our drug candidates; |
| ● | the size and growth potential of the markets for our drug candidates; |
| ● | our ability to raise additional capital; |
| ● | our commercialization, marketing and manufacturing capabilities and strategy; |
| ● | our expectations regarding our ability to obtain and maintain intellectual property; |
| ● | our ability to contract with third-party suppliers and manufacturers and their ability to perform adequately; |
| ● | how long we will qualify as an emerging growth company or a foreign private issuer; |
| ● | our estimates regarding future revenue, expenses and needs for additional financing; |
| ● | our belief about the duration of our cash runway; |
| ● | regulatory developments in the United States, European Union and other jurisdictions; and |
| ● | other risks and uncertainties, including those listed in this section of this Annual Report on Form 20-F titled “Item 3.D—Risk Factors.” |
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You should refer to the section of this Annual Report on Form 20-F titled “Item 3.D—Risk Factors” for a discussion of important factors that may cause our actual results to differ materially from those expressed or implied by our forward-looking statements. As a result of these factors, we cannot assure you that the forward-looking statements in this Annual Report on Form 20-F will prove to be accurate. Furthermore, if our forward- looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame or at all. We undertake no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
You should read this Annual Report on Form 20-F and the documents that we reference in this Annual Report on Form 20-F and have filed as exhibits to this Annual Report on Form 20-F completely and with the understanding that our actual future results may be materially different from what we expect. We qualify all of our forward-looking statements by these cautionary statements.
This Annual Report on Form 20-F contains market data and industry forecasts that were obtained from industry publications. These data involve a number of assumptions and limitations, and you are cautioned not to give undue weight to such estimates. We have not independently verified any third-party information. While we believe the market position, market opportunity and market size information included in this Annual Report on Form 20-F is generally reliable, such information is inherently imprecise.
This Annual Report on Form 20-F contains estimates, projections and other information concerning our industry, our business and the markets for our drug candidates. Information that is based on estimates, forecasts, projections, market research or similar methodologies is inherently subject to uncertainties, and actual events or circumstances may differ materially from events and circumstances that are assumed in this information. Unless otherwise expressly stated, we obtained this industry, business, market and other data from our own internal estimates and research as well as from reports, research surveys, studies and similar data prepared by market research firms and other third parties such as investment banking analysts, industry, medical and general publications, government data and similar sources. In addition, assumptions and estimates of our and our industry’s future performance are necessarily subject to a high degree of uncertainty and risk due to a variety of factors, including those described in the section titled “Item 3.D—Risk Factors.” These and other factors could cause our future performance to differ materially from our assumptions and estimates.
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PART I
Item 1. Identity of Directors, Senior Management and Advisers.
Not applicable.
Item 2. Offer Statistics and Expected Timetable.
Not applicable.
Item 3. Key Information.
A.[Reserved]
B. | Capitalization and Indebtedness |
Not applicable.
C.Reasons for the Offer and Use of Proceeds
Not applicable.
D.Risk Factors
Our business faces significant risks. You should carefully consider all of the information set forth in this Annual Report on Form 20-F and in our other filings with the United States Securities and Exchange Commission, or the SEC, including the following risk factors which we face, and which are faced by our industry. Our business, financial condition, results of operations and growth prospects could be materially adversely affected by any of these risks. This report also contains forward-looking statements that involve risks and uncertainties. Our results could materially differ from those anticipated in these forward-looking statements, as a result of certain factors including the risks described below and elsewhere in this Annual Report and our other SEC filings. See “Special Note Regarding Forward-Looking Statements” above.
Summary Risk Factors
| ● | We will need significant amounts of additional new capital to fund our continued development activities; |
| ● | We are currently conducting some of our business operations under a service agreement with Neurosterix Group. In order to internally develop our programs, we may need to significantly expand our operations; |
| ● | We are a development-stage company working with novel approaches to therapeutics, which may not be successful; |
| ● | We have no products on the market and we may never generate revenue from the sale or licensing of drug candidates; |
| ● | Our dependence on Indivior or any future partner to develop and commercialize our drug candidates expose us to significant risks; |
| ● | We may be deemed to be an investment company under the Investment Company Act of 1940, including as a result of our interest in Neurosterix; |
| ● | If third parties on which we depend to conduct our clinical trials do not perform as contractually required, fail to satisfy regulatory or legal requirements or miss expected deadlines, our clinical development program could be delayed and otherwise adversely affected; |
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| ● | We are subject to U.S and foreign anti-corruption laws and regulations, export and import controls, sanctions and embargoes; |
| ● | Our ADSs may be delisted from Nasdaq which could negatively impact the price of our ADSs, our liquidity and our ability to access the capital markets; |
| ● | The value of our ADSs may be driven by the release of preclinical and clinical studies led by Neurosterix Group; |
| ● | Because we rely on third party manufacturing and supply partners, our clinical development supplies and other materials may become limited or interrupted or may not be of satisfactory quality; |
| ● | Our drug candidates must prove their efficacy and safety in rigorous clinical testing that is expensive, time-consuming and may be delayed, suspended or terminated at any time. |
| ● | We face competition from entities that have developed or may develop similar or different drug candidates aimed at the indications on which we are focusing. |
| ● | Any commercialization efforts by us will require us to develop sales, marketing and distribution capabilities internally or through arrangements with third parties. |
| ● | The exercise of equity incentive instruments granted under our equity incentive plan or warrants granted to Investors could dilute our share capital. |
| ● | We have determined that we are a “passive foreign investment company,” or PFIC, for U.S. federal income tax purposes, for which the consequences to U.S. holders of our shares or ADSs representing our shares may be adverse. |
Risks Related to Our Business
We will need significant amounts of additional new capital to fund our continued development activities.
We incurred accumulated losses for a total amount of CHF 353 million since inception. During the twelve-month period ended December 31, 2024, we generated a net profit of CHF 7.18 million primarily due to reduced operating losses and proceeds from the divestment of part of our business to Neurosterix on April 2, 2024. As part of this transaction, we received a gross proceeds of CHF 5.0 million and a 20% equity interest in Neurosterix US Holdings LLC, parent company of Neurosterix Group.
Our operating losses result principally from costs incurred in research and development of our drug candidates and general and administrative expense. In the medium and long term, we expect to increase our expenses as we continue the development of our GABAB PAM chronic cough drug candidate, initiate further clinical trials and seek marketing approval for our drug candidates. The amount of future losses is uncertain and our ability to achieve a recurring profitability, if ever, will depend on, among other things, us or our partners successfully developing drug candidates, obtaining regulatory approval to market and commercialize drug candidates, manufacturing any approved products on commercially reasonable terms, establishing a sales and marketing organization or suitable third party alternatives for any approved product and raising sufficient funds to finance our activities.
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We will need significant amounts of additional new capital to fund the development of our GABAB PAM chronic cough drug candidate and our other drug programs and we cannot guarantee that we will have sufficient funds available in the future to develop and commercialize this indication or our other drug programs. As of December 31, 2024, we had cash and cash equivalents of CHF 3.3 million. To date, we have funded our operations through equity offerings, payments from licensors and divestment of selected assets. We have limited sources of revenue and will need substantial additional capital to develop and commercialize our drug candidates. We may be unable to raise additional capital when needed, or at all, which could force us to reduce or discontinue operations.
We believe that our current cash and cash equivalents are sufficient to fund our operating expenses through mid-June 2026. We cannot assure you of our ability to finance our operations and pursue our intended development plans beyond that date as it will depend on our ability to generate additional funding through current and further partnerships or grants and amounts we may raise through further financings such as additional equity offerings, including offerings under our sale agreement with Kepler Cheuvreux. If our development plans are not successful, we may not be able to generate additional funding through partnerships or grants, or raise further financing through equity offerings or otherwise, or we may only be able to do so on terms that are not favorable to our shareholders.
To the extent that we raise additional capital through the issuance of shares, our existing shareholders will be diluted and newly issued shares may contain senior rights and preferences compared to currently outstanding shares. We may receive future milestone payments from licensors but that is dependent on achieving certain regulatory or commercial milestones that may never happen. We may seek additional funding through public or private financings, debt financing or collaboration agreements. The inability to obtain funding, as and when needed, would have a negative impact on our financial condition and ability to pursue our business strategies. If we are unable to obtain the required funding to run our operations and to develop and commercialize our candidates, we could be forced to postpone the development of our drug candidates.
We are currently conducting some of our business operations under a service agreement with Neurosterix Group. In order to internally develop our programs, we may need to significantly expand our operations.
On April 2, 2024, we sold our allosteric modulator drug discovery technology platform and some of our wholly owned pre-clinical programs to Neurosterix Pharma Sàrl (Neurosterix), a new company funded by Perceptive Xontogeny Venture Fund II L.P, Perceptive Life Sciences Master fund Ltd and Acorn Bioventures 2, L.P (the “Transaction”). As part of the Transaction, Addex received CHF 5.0 million in cash and shares representing a 20% indirect equity interest in Neurosterix. As of the date of the Transaction, all employees of Addex, other than our Head of Finance, became employees of Neurosterix. Pursuant to a service agreement, certain former Addex employees are allowed to dedicate a portion of their time to Addex at zero cost. If Neurosterix Group terminates the service agreement, we may need to significantly expand our operations and hire new research and development staff in order to continue to develop our programs. We may not be successful in expanding our operations, and any such expansion may be expensive.
We have no products on the market and we may never commercialize our drug candidates.
Our ability to achieve and sustain profitability depends on obtaining regulatory approvals for and successfully commercializing our drug candidates, either alone or with third parties, such as our partner Indivior for GABAB PAM for the substance use disorders indication. Currently, none of our drug candidates have been approved for marketing and commercialization or is in Phase 3 trials. We cannot guarantee that any of our drug candidates will be successfully tested, approved by the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), Swissmedic, Swiss Agency for Therapeutic Products, or any other regulatory agency or marketed and commercialized at any time in the foreseeable future or at all. If approval is obtained for a drug candidate, we cannot assure you that we will be able to generate or sustain revenue from any sales due to factors such as whether the product is manufactured at a competitive cost or accepted in the market, as well as general and industry-specific local and international economic pressures. Should we progress a program for a rare disease indication with the potential for orphan drug designation, the size of the patient population for even an approved product is limited.
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Our business could be adversely affected by health pandemics and geopolitical risks
Our business could be adversely affected by health epidemics and geopolitical risks in regions where we or our partners have concentrations of clinical trial sites or other business operations and could cause significant disruption in the operations of third-party manufacturers and CROs upon whom we or our partners rely. Health pandemics may pose the risk that we, employees, contractors, collaborators and our partners may be prevented from conducting certain pre-clinical tests, clinical trials or other business activities for an indefinite period of time, including due to travel restrictions, quarantines, “stay-at-home” and “shelter-in-place” orders or shutdowns that have been or may in the future be requested or mandated by governmental authorities. For example, the COVID-19 pandemic impacted and could in the future impact our business and clinical trials led us or by partners, including as a result of delays or difficulties in clinical site initiation, difficulties in recruiting and retaining clinical site investigators and clinical site staff and interruption of our clinical supply chain or key clinical trial activities, such as clinical trial site monitoring, and supply chain interruptions caused by restrictions for the supply of materials for drug candidates or other materials necessary to manufacture product to conduct clinical and preclinical tests. Macroeconomic and geopolitical risks such as interest rates, inflation, political conditions, changes in trade policies (including tariffs) and the Russia-Ukraine war or conflicts in the Middle East may create global security concerns including the possibility of an expanded regional or global conflict and potential ramifications such as disruption of the supply chain including research and development activities being conducted by us and our strategic partners. Delays in research and development activities of us and our partners could increase associated costs and, depending upon the duration of any delays, require us and our partners to find alternative suppliers at additional expense. In addition, Russia-Ukraine war has had significant ramifications on global financial markets, which may adversely impact our ability to raise capital on favorable terms or at all.
If we were deemed to be an investment company under the Investment Company Act of 1940, as amended, or the 1940 Act, including as a result of our interest in Neurosterix, applicable restrictions could make it impractical for us to continue our business as contemplated and could have a material adverse effect on our business.
Under Sections 3(a)(1)(A) and (C) of the 1940 Act, a company generally will be deemed to be an “investment company” for purposes of the 1940 Act if (1) it is, or holds itself out as being, engaged primarily, or proposes to engage primarily, in the business of investing, reinvesting or trading in securities, or (2) it engages, or proposes to engage, in the business of investing, reinvesting, owning, holding or trading in securities and it owns or proposes to acquire investment securities having a value exceeding 40% of the value of its total assets (exclusive of U.S. government securities and cash items) on an unconsolidated basis. We do not believe that we are an “investment company,” as such term is defined in either of those sections of the 1940 Act.
We believe that we are engaged in the business of developing and commercializing pharmaceutical drugs and not in the business of investing, reinvesting or trading in securities and we do not propose to engage primarily in the business of investing, reinvesting or trading in securities. Moreover, we and Neurosterix intend to conduct our operations so that we will not be deemed an investment company. Because, we have a designated board seat held by our Chairman of the Board, protective provisions and rights to participate in the Board of Neurosterix, we believe that our interest in Neurosterix is not an “investment security” as that term is used in the 1940 Act. However, if Neurosterix itself becomes an investment company or we were to cease to have a seat at Neurosterix board, our interest in the Neurosterix could be deemed an “investment security” for purposes of the 1940 Act. If it were established that we were an unregistered investment company, we could be subject to monetary penalties and injunctive relief in an action brought by the SEC, we could be unable to enforce contracts with third parties and third parties could seek to obtain rescission of transactions undertaken during the period it was established that we were an unregistered investment company. If we were required to register as an investment company, restrictions imposed by the 1940 Act, including limitations on our capital structure and our ability to transact with affiliates, could make it impractical for us to continue our business as contemplated and could have a material adverse effect on our business.
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Our dependence on Indivior or any future partner to develop and commercialize drug candidates expose us to significant risks.
Our collaborations with Indivior or any future partner, may not be scientifically, clinically or commercially successful. We are dependent upon Indivior, and may be dependent upon any other partners with which we may collaborate in the future, to perform and fund development activities, including clinical testing, regulatory filings and the manufacture and marketing of products. Under our collaboration and license agreements with Indivior, our partners have sole responsibility for the financing and development of selected compounds through preclinical and clinical trials, as well as registration procedures and commercialization, if any, in the United States, Japan, United Kingdom, Germany, France, Spain and Italy. Our partners have authority over all aspects of the development of selected compounds and may develop or commercialize third-party compounds with a different mechanism of action for identical use. Our role on the joint development committees formed under the collaboration and license agreements is advisory and we do not have authority to determine or veto actions. Our partners may take independent action concerning product development, marketing strategies, manufacturing and supply issues and rights relating to intellectual property.
The success of our GABAB PAM program for the treatment of CNS and related diseases currently depends entirely upon the efforts of Indivior. Indivior has significant discretion in determining the efforts and resources it applies to the development and, if approval is obtained, commercialization and marketing of GABAB PAM programs. Indivior may not be effective in obtaining approvals in their respective fields of use, marketing any approved products or arranging for any necessary sublicense, supply, manufacturing or distribution relationships, or our partners may change their strategic focus or pursue alternative technologies in a manner that results in reduced or delayed revenue to us. Our partners have a variety of marketed products and their own corporate objectives may not be consistent with our best interests. Changes of this nature might also occur if our partners are acquired or experience changes in management. In any future disagreement with us, our partners will have significantly greater financial and managerial resources on which to draw. Any disagreement could lead to lengthy and expensive litigation or other dispute resolution proceedings as well as extensive financial and operational consequences to us and have a material adverse effect on our business, financial conditions, results of operations and prospects.
Our Partner Janssen terminated the development of our drug candidate in epilepsy and returned to us this drug candidate
On July 22, 2024, we announced that our Partner Janssen terminated the development of drug candidate ADX71149, because the Phase 2 study did not achieve statistical significance for the primary endpoint. On April 17, 2025, we announced that our partner Janssen terminated our partnership agreement and returned to us the program including all related intellectual property to the Group. We are currently evaluating the future development of ADX71149.
Our failure to collaborate successfully with partners may delay, impair or prevent the development or commercialization of our drug candidates.
Our business strategy requires us to enter into various forms of collaboration arrangements with other companies, licensors or licensees to research, develop and commercialize our drug candidates. We cannot assure you that we will be able to maintain our existing collaboration with Indivior, negotiate collaboration arrangements in the future on acceptable terms with first choice partners, if at all, or that any such collaboration arrangements will be successful. To the extent that we are not able to maintain or establish such arrangements, we would be forced to seek alternatives, including undertaking drug development and commercialization activities on our own, which would increase our capital requirements and could require us to limit the scope of some or all of our other research and development activities. Under a collaboration agreement, we are likely to have limited influence over the future development or commercialization of the relevant drug candidates. Such development or commercialization may depend significantly on the efforts and activities of the collaborator. Under the terms of an agreement, a collaborator may have significant discretion in determining the efforts and resources it dedicates to the collaboration, which may change over time depending on the collaborator’s overall strategic priorities. The suspension or termination of our collaboration arrangements, the failure of our collaboration arrangements to be successful or the delay in the development or commercialization of drug candidates pursuant to collaborations could have a material adverse effect on our business, financial condition, results of operations and prospects.
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If third parties on which we depend to conduct our preclinical studies and clinical trials do not perform as contractually required, fail to satisfy regulatory or legal requirements or miss expected deadlines, our preclinical studies and clinical development programs could be delayed and otherwise adversely affected.
We rely on third party clinical investigators, contract research organizations, or CROs, clinical data management organizations, medical institutions and consultants to design, conduct, supervise and monitor preclinical studies and clinical trials in relation to our drug candidates. Because we rely on third parties and do not have the ability to conduct clinical and preclinical trials independently, we have less control over the timing, quality and other aspects of clinical trials than we would if we conducted them on our own. These investigators, CROs and consultants are not our employees and we have limited control over the amount of time and resources that they dedicate to our programs. These third parties may have contractual relationships with other entities, some of which may be our competitors, which may draw time and resources from our programs. If we cannot contract with acceptable third parties on commercially reasonable terms, or at all, or if these third parties do not carry out their contractual duties, satisfy legal and regulatory requirements for the conduct of clinical trials or meet expected deadlines, our clinical development program could be delayed or otherwise adversely affected. In all events, we are responsible for ensuring that each of our clinical trials is conducted in accordance with the general investigational plan and protocols for the trial. The FDA requires us to comply with good clinical practices for conducting, recording and reporting the results of clinical trials to assure that data and reported results are credible and accurate and that the rights, integrity and confidentiality of trial participants are protected. Our reliance on third parties that we do not control does not relieve us of these responsibilities and requirements. The third parties with which we contract might not be diligent, careful or timely in conducting our clinical trials, as a result of which the clinical trials could be delayed or unsuccessful. Any such event could have a material adverse effect on our business, financial condition, results of operations and prospects.
Because we rely on third party manufacturing and supply partners, our clinical development supplies and other materials may become limited or interrupted or may not be of satisfactory quantity.
We rely on third party manufacturing and supply partners for our research and development, preclinical studies and clinical trials. We currently do not have in-house facilities to manufacture our research and development, preclinical and clinical drug supplies. In the event that any of our suppliers, for research and development, or preclinical studies or clinical trials, fail to perform their respective obligations in terms of quality, timing or otherwise, or if our supply of such components or other materials become limited or interrupted for other reasons, we may not be able to develop or market our drug candidates on a timely and cost-competitive basis, if at all, which may have a material adverse effect on our business, financial condition, results of operations and prospects. There can be no assurance that our supply of research and development, preclinical and clinical development drugs and other materials will not be limited, interrupted, restricted in certain geographic regions or of satisfactory quality. If the suppliers that currently manufacture our clinical drug supplies cannot continue to do so, we can provide no assurance that we will be able to obtain alternative components and materials from other manufacturers of acceptable quality, or on terms or in quantities acceptable to us, or that we will not require additional components and other materials to manufacture or use our drug candidates. In addition, suppliers need to meet applicable manufacturing requirements and undergo rigorous facility and process validation tests required by regulatory authorities in order to comply with applicable regulatory standards, such as current Good Manufacturing Practices, or cGMP. We cannot provide assurance that our suppliers will comply with such requirements.
Our drug candidates may not successfully obtain regulatory approval.
Even if Phase 3 clinical trials are initiated in any drug product candidate and they are completed, there can be no assurance that we will receive approval from the FDA, the EMA, Swissmedic, Swiss Agency for Therapeutic Products, or any other relevant government agencies. Any approval may be delayed or may be obtained on restrictive terms. This may occur if a drug candidate does not show acceptable safety and efficacy in preclinical studies and clinical trials or otherwise does not meet applicable regulatory standards for approval or the drug candidate does not prove as effective as, or does not offer therapeutic or other improvements over, existing or future drugs used to treat the same or similar illness or conditions. Failure by us or a partner to obtain approval for drug candidates could have a material adverse effect on our business, financial condition, results of operations and prospects.
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Our drug candidates must prove their efficacy and safety in rigorous clinical testing that is expensive, time-consuming and may be delayed, suspended or terminated at any time.
Drug approval requires extensive, time consuming and expensive clinical testing to demonstrate safety, tolerability and efficacy of a drug and meet other regulatory standards for authorization to market and commercialize. The development of innovative drugs is inherently risky and the utility and success of a drug will depend on its efficacy and side effect profile for the target patient population. Preclinical studies and clinical trials are long, expensive and uncertain processes. Successful results obtained in preclinical studies and early clinical trials may not be predictive of results in later clinical trials and do not ensure that later preclinical studies or clinical trials will be successful. Clinical trials may be delayed, suspended or terminated as a result of many factors, many of which are or may be beyond our control, such as:
| ● | suspension or termination of clinical trials by regulators, institutional review boards or data safety monitoring boards; |
| ● | termination due to safety issues or lack of efficacy of the drug tested; |
| ● | a collaboration partner’s termination of an arrangement with us or inadequate dedication of financial or other resources towards development under an arrangement with us; |
| ● | inability to enter into adequate collaboration arrangements to complete the development or commercialization and manufacturing of our drug candidates; |
| ● | insufficient availability of a drug candidate in accordance with cGMP quality;or |
| ● | slower than expected enrollment of patients or lack of compliance by patients. |
We or a partner may be required to conduct clinical trials or other testing of drug candidates beyond those currently contemplated, in particular, if the currently contemplated trials fail to complete successfully or if the results of those trials or tests are negative or inconclusive. It may take us several years to complete this testing, if at all, and failure can occur at any stage of the process, which could delay, increase costs associated with or prevent approval or commercialization of a drug candidate. Even after approval, if any, a drug may be shown to be unsafe or not have its purported effect. As a result, we or a partner may be required to conduct additional trials or studies, be subject to fines, suspension or withdrawal of approval, drug recalls, product seizures, operating restrictions or criminal prosecution. In all such cases, our anticipated development or commercialization timelines may not be met, which could have a material adverse effect on our business, financial condition, results of operations and prospects.
We face competition from entities that have developed or may develop similar or different drug candidates aimed at the indications on which we are focusing.
The development and commercialization of drugs is highly competitive. We compete with a variety of multinational pharmaceutical companies and specialized pharmaceutical companies, including products approved for marketing and/or drug candidates under development, for each of the drug candidates and each of the indications for which we are developing our drug candidates, as well as technology being developed at universities and other research institutions. Many of our competitors have significantly greater financial, technical, manufacturing, marketing, sales and supply resources or experience than we have. Our competitors have developed, are developing or will develop drug candidates and processes that will compete with our drug candidates. Competitors may enjoy a significant competitive advantage if they are able to achieve patent protection, obtain marketing authorizations and commence commercial sales of their drugs before us. Competing drugs could present superior treatment alternatives for our targeted indications, including by being more effective, safer or convenient, and even make our drug candidates or know-how obsolete before we reach the market. In addition, competitors may sell drugs below the price level at which appropriate return for our investment in drug development is possible. As a result of these factors, we may be unable to successfully develop commercially feasible drugs and our commercial opportunities may be reduced or eliminated, and we may not be able to successfully compete. This would have a material adverse effect on our business, financial condition, results of operations and prospects.
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We may fail to obtain, maintain or enforce licenses, patents and proprietary technology.
Our success depends in part on our ability to obtain patent protection for our drug candidates and processes, preserve our trade secrets and other proprietary rights and to defend and enforce our rights against infringement in Europe, the United States and other countries. If we are unable to do so, our drugs, technologies and know-how may not provide us with a competitive advantage. The validity and breadth of claims in patent applications involve complex legal and factual questions and, therefore, involve uncertainty. We owned 9 U.S. and 130 foreign patents and a number of pending patent applications that cover various aspects of our technologies at the issuance date of this annual report on Form 20-F. No assurance can be given that patents based on pending patent applications or any future patent applications will be issued. We may need to refine or narrow our claims. Due to their broad scope, some of our generic compound claims may not be patentable. Other of our patent applications may not be granted if third parties have earlier filed applications for inventions covered by our pending patent applications. The scope of any patent protection we are able to obtain may not provide us with sufficient protection against competing drugs or provide competitive advantages to us. Any of the patents that have been or may be issued to us may be held invalid or unenforceable if subsequently challenged by competitors or other third parties. Furthermore, there can be no assurance that others have not developed or will not develop similar drugs, duplicate any of our drugs or design around any patents that have been or may be issued to us. Any of our granted, valid and enforceable patents will provide protection for only a limited period of time. We cannot assure that we will obtain any extensions of patent protection that are sometimes offered if certain clinical development extension application deadlines are met or that we will be successful in seeking any method of use patent. If a method of use patent is granted but product patents are not granted or expire, third parties would be able to develop products using the method in indications not covered by the method of use patent.
We may be restricted in our development and any commercialization activities by third-party patents and patent applications.
Our commercial success depends on our ability to operate without infringing third-party patents and other intellectual property or market exclusivity rights. If we are not able to do so, we may be subject to infringement actions. We may not be aware of all patents and patent applications that may impact our ability to make, use or sell our drug candidates. Other parties may have filed, or may file in the future, patent applications covering compounds or drug candidates that are similar to ours. Any such event could have a material adverse effect on our business, financial condition, results of operations and prospects. In addition, because patent applications can take many years to issue and are not published for a period of time ranging on the jurisdictions in which we applied for registration, there may be applications currently pending, unknown to us, which may later result in patents that our drug candidates or technology may infringe. Any conflicts arising from the patent rights of others could significantly reduce the scope of our patents and limit our ability to obtain meaningful patent protection. We may be required to obtain licenses to those patents or to develop or obtain alternative technology. We may not be able to obtain any such licenses on acceptable terms, or at all. Any failure to obtain such licenses could delay or prevent us from pursuing the development or commercialization, if any, of our drug candidates.
We may fail to protect our intellectual property rights, including trade secrets and know-how.
Our success depends on our ability to obtain and enforce intellectual property rights, including trade secrets and non-patentable know-how related to our allosteric modulator platform. We seek to protect or secure this intellectual property, in part, by entering confidentiality agreements with and receiving assignments from our employees, consultants, suppliers, licensees, funding partners and other contractual partners and advisers. We may not always be able to obtain these agreements or assignments. Even if we obtain these agreements or assignments, there can be no assurance that they will effectively protect our intellectual property rights or prevent improper use or disclosure of confidential information or that they will not be breached. We may not have adequate remedies for any breach of these agreements or assignments, or our trade secrets or non-patentable know-how may otherwise become known or be independently developed by competitors. In addition, these agreements or assignments may conflict with, or be subject to, the rights of third parties with which our employees, consultants, suppliers, licensees, funding partners or other contractual partners or advisers had previous employment, consulting or other relationships. Any such event could have a material adverse effect on our business, financial condition, results of operations and prospects.
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We may have to defend against or initiate lawsuits to protect our intellectual property rights.
In the future, third parties with patent claims that overlap with our intended activities may decide to sue us for monetary damages or to prevent us from manufacturing, selling or developing our drug candidates. We could also become subject to claims that we or our employees have inadvertently or otherwise used or disclosed intellectual property, trade secrets or other proprietary information of an employee’s former employer, particularly if such employer is a university or pharmaceutical company. Additionally, to protect our patent rights, we may decide to initiate lawsuits against third parties. Defending against or initiating such claims, which typically go on for years before a legal judgment or settlement is obtained, would involve significant effort and expense and could divert management’s attention from the operation of our business. Any such proceedings could involve prior art and put our patents at risk of being invalidated or interpreted narrowly and our pending patent applications at risk of not being issued. In addition, there is a risk that some of our confidential information could be compromised by disclosure in such proceedings and provide competitors with access to our proprietary information. Further, the outcome of any such proceedings may be unfavorable to us. If the manufacture, use or sale of any of our drug candidates infringes the patents, or violates other proprietary rights, of third parties, a court or settlement agreement may require us to pay actual damages and, potentially, penalties, including the other party’s attorney’s fees, which may be substantial. We could also be required to cease the development, manufacture, use and sale of drugs that infringe the patent rights of others, to expend significant resources to redesign our technology so that it does not infringe the patent rights of others, to develop or acquire non-infringing technology, which may not be possible, or to obtain licenses to the infringed intellectual property, which may not be available to us on acceptable terms or at all. We cannot guarantee that we will have sufficient financial or other resources to protect intellectual property significant to the development of our drug candidates.
Even if a product candidate receives regulatory approval, lack of market acceptance may prevent us from generating revenue from commercialization of the product.
Even if a drug candidate is approved, if we or a partner are not successful in commercializing the product, we will not generate revenue from sales. Revenue generated from an approved product depends on its successful commercialization. Many factors may impede successful commercialization, many of which are or may be beyond our or a partner’s control. These factors include the proprietary rights of third parties, including our competitors, the failure of a product to prove effective as, or offer therapeutic or other improvements over, existing or future drugs used to treat the same or similar conditions or the inability of a product to gain acceptance by patients, the medical community or third-party payors, such as insurance companies or government reimbursement programs, or the inability of produce a product in commercial quantities at an acceptable cost, or at all. Even if our drug development is successful and marketing authorization has been obtained, our ability, or our partners’ ability, to generate significant revenue will depend on the acceptance of our drugs by physicians, patients, third-party payors and the medical community. We cannot assure you that we or our partners will achieve market acceptance of our drug candidates or generate revenue once we or our partners obtain marketing authorization. The market acceptance of any of our drug candidates depends on a number of factors, including the continued demonstration of efficacy and safety in commercial use, cost-effectiveness, convenience and ease of administration, competition, marketing and distribution support, the scope of the approved uses and labeling requirements, prevalence and severity of any side effects, and adequate government or other third-party coverage or reimbursement for the cost of the drug. To the extent competitors are able to commercialize competing drugs before our drugs have achieved market approval and acceptance, we may have difficulty gaining market acceptance if physicians, patients, third- party payors and the medical community have grown accustomed to use of the competing drugs, whether or not such competing drugs are more effective or have other advantages over our drug.
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Any commercialization efforts by us will require us to develop sales, marketing, and distribution capabilities internally or through arrangements with third parties.
Sales, marketing and distribution capabilities are key elements of a successful commercialization strategy, none of which we currently have internally. If any of our product candidates are approved, we intend to market the product either directly or through other strategic alliances and distribution arrangements with third parties. To commercialize our drugs, we will need to enter into new collaborations with third parties or develop our own marketing and sales force with technical expertise and supporting distribution capability. If we decide to market our products directly, we will need to commit significant financial and managerial resources to develop a marketing and sales force with technical expertise and with supporting distribution, administration and compliance capabilities. If we rely on third parties with such capabilities to market our products, we will need to establish and maintain partnership arrangements, and there can be no assurance that we will be able to enter into third-party marketing or distribution arrangements on acceptable terms or at all. To the extent that we do enter into such arrangements, we will be dependent on our marketing and distribution partners. In entering into third-party marketing or distribution arrangements, we expect to incur significant additional expense and there can be no assurance that such third parties will establish adequate sales and distribution capabilities or be successful in gaining market acceptance for our products and services. Any factors preventing or limiting the market acceptance of our drug candidates could have a material adverse effect on our business, financial condition, results of operations and prospects. There can be no assurance that we will be able to build up our own marketing and sales organization, to attract and maintain established collaboration partners for the third-party commercialization of our drug candidates, to enter into agreements on acceptable terms for sales and marketing, if at all, or that any such collaboration arrangements will be successful. As a consequence, we would be forced to seek alternatives, redirect our resources or have to limit the scope of our research and development activities in other fields and thereby delay the launch and sales of any or all of our drug candidates, or raise new funds. Accordingly, this could have a material adverse effect on our business, financial condition, results of operations and prospects.
We may become exposed to costly and damaging liability claims and may not be able to maintain sufficient liability insurance to cover these claims.
Our business with pharmaceutical drugs entails a potential risk of substantial liability for damages, including drug liability and environmental liability, which are inherent in the development, testing and manufacturing of our drug candidates. It is always possible that a drug, even after marketing authorization, may exhibit unforeseen failures or adverse side effects. We can provide no assurance that sufficient insurance coverage will be available to us at acceptable terms, or at all, for any damages or costs in connection with any liability claims. Liability lawsuits are costly and time consuming and may divert management’s attention from their normal responsibilities. If any of our drugs were to fail or produce adverse side effects, substantial uninsured losses could result, which could have a material adverse effect on our business, financial condition, results of operations and prospects. Even where drug failures or side effects are not so serious as to warrant withdrawing the drug from the market or liability in damages, they may reduce the drug’s competitiveness or adversely affect our reputation, which could have a material adverse effect on our business, financial condition, results of operations and prospects.
We and our partners are subject to significant government regulation, including marketing authorization requirements, which could increase the cost of developing our drug candidates or delay, prevent or limit the commercialization of our drug candidates.
We and our partners are subject to extensive and rigorous governmental regulation and the applicable regulatory requirements are subject to change. Our and our partners’ research and development, preclinical studies and clinical trials, manufacturing, safety, efficacy, record-keeping, labeling, marketing, sales and distribution of our drug candidates are regulated by the EMA, the FDA, Swissmedic, Swiss Agency for Therapeutic Products, and other government agencies in countries where we are testing or intend to test and market our drug candidates. Before a clinical trial can begin, we and our partners must obtain approval from the competent national authority in the country where the trial is planned to be conducted. A favorable opinion from a competent ethics committee or an independent institutional review board on the clinical trial application is also needed. We cannot assure we or our partners will obtain authorization for further testing of drug candidates already in clinical trials or for human clinical trials of any or all of our other candidates currently in research or pre-clinical development. We, and our partners or regulatory authorities may suspend or terminate clinical trials at any time if it is thought that the participants are being exposed to unacceptable health risks. It may take us or our collaborators several years to complete this testing, and failure can occur at any stage of the process.
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The governmental regulation of development of drug candidates extends beyond clinical trials to approvals required for their sale and monitoring after sale, including safety reporting requirements, regulatory oversight of drug promotion and marketing and cGMP. A failure by us or our partners to obtain marketing authorization or a delay in obtaining and maintaining approval could damage our reputation and adversely affect the marketing of our drugs and our ability to generate revenue, which could have a material adverse effect on our business, financial condition, results of operations and prospects. In addition, marketing authorizations, if granted, may not include all uses for which we may seek to market a drug, thereby limiting the potential market for the drug. Moreover, even after marketing authorization is obtained, a marketed drug, its manufacturer and its manufacturing facilities are subject to continual review and periodic inspections by the relevant authorities. Consequently, any discovery of previously unknown problems with an approved drug, manufacturer or manufacturing facilities may result in restrictions on the drug or manufacturer, including a requirement to withdraw the drug from the market. In addition, regulatory requirements are evolving in a manner that cannot be predicted. Changes in existing regulations of EMA, FDA, Swissmedic, Swiss Agency for Therapeutic Products or other regulations or the adoption of new regulations could prevent us from obtaining or maintaining, or affect the timing of, future marketing authorizations. Changes in regulatory policy during the period of development of a drug or regulatory review may result in delays or rejections of approvals of the drug candidates. Any change in the regulations governing us could have a material adverse effect on our business, financial condition, results of operations and prospects.
Our relationships with customers, physicians and third-party payors are subject, directly or indirectly, to United States federal and state healthcare fraud and abuse laws, privacy and security laws (including health information privacy and security laws), and other healthcare laws and regulations. If we or our employees, independent contractors, consultants, commercial partners and vendors violate these laws, we could face substantial penalties.
Our current and future arrangements with healthcare professionals, principal investigators, consultants, customers (including governmental bodies) and third-party payors subject us to various federal and state fraud and abuse laws and other healthcare laws. These laws may impact, among other things, our current and future business operations, including our clinical research activities, and proposed sales, marketing and education programs and constrain the business or financial arrangements and relationships with healthcare providers and other parties through which we market, sell and distribute our products for which we obtain marketing approval. These laws include, without limitation, anti-kickback and false claims laws and regulations, data privacy and security laws, and transparency laws and regulations. Because of the breadth of these laws and the narrowness of the statutory exceptions and regulatory safe harbors available, it is possible that some of our business activities could be subject to challenge under one or more of such laws. It is possible that governmental authorities will conclude that our business practices may not comply with current or future statutes, regulations or case law involving applicable fraud and abuse or other healthcare laws and regulations. If our operations are found to be in violation of any of these laws or any other governmental regulations that may apply to us, we may be subject to substantial civil, criminal and administrative penalties, damages, fines, disgorgement, imprisonment, exclusion from participating in government funded healthcare programs, such as Medicare and Medicaid, additional reporting requirements and oversight if we become subject to a corporate integrity agreement or similar agreement to resolve allegations of non-compliance with these laws, contractual damages, reputational harm and the curtailment or restructuring of our operations. To the extent that any of our products are sold in a foreign country, we may be subject to similar foreign laws and regulations, which may include, for instance, applicable post marketing requirements, including safety surveillance, anti-fraud and abuse laws and implementation of corporate compliance programs and reporting of payments or transfers of value to healthcare professionals.
Current healthcare laws and regulations and future legislative or regulatory changes to the healthcare system may affect our ability to sell any drugs we may develop.
Healthcare laws are subject to change, which may affect our ability to sell any product candidates for which we receive marketing and commercialization approval. In the U.S., an important potential market for our drug candidates, there have been a number of legislative and regulatory changes to the healthcare system that could affect our future results of operations. In particular, there have been and continue to be a number of initiatives at the U.S. federal and state levels that seek to reduce healthcare costs.
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Individual states in the United States have become increasingly aggressive in passing legislation and implementing regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access, and marketing cost disclosure and transparency measures, and designed to encourage importation from other countries and bulk purchasing. Legally-mandated price controls on payment amounts by third-party payors or other restrictions could harm our business, results of operations, financial condition and prospects. In addition, regional healthcare authorities and individual hospitals in the United States are increasingly using bidding procedures to determine what pharmaceutical products and which suppliers will be included in their prescription drug and other healthcare programs. This could reduce ultimate demand for our products or put pressure on our product pricing, which could negatively affect our business, results of operations, financial condition and prospects. In addition, given recent federal and state government initiatives directed at lowering the total cost of healthcare, Congress and state legislatures will likely continue to focus on healthcare reform, the cost of prescription drugs and biologics and the reform of the Medicare and Medicaid programs. While we cannot predict the full outcome of any such legislation, it may result in decreased reimbursement for drugs and biologics, which may further exacerbate industry-wide pressure to reduce prescription drug prices. This could harm our ability to generate revenue. At the federal level, on August 16, 2022, the Inflation Reduction Act of 2022, or IRA, was signed into law, which, among other things (i) directs the U.S. Department of Health and Human Services, or HHS to negotiate the price of certain high-expenditure, single-source drugs that have been on the market for at least 7 years covered under Medicare, or the Medicare Drug Price Negotiation Program, and (ii) imposes rebates under Medicare Part B and Medicare Part D to penalize price increases that outpace inflation. These provisions take effect progressively starting in fiscal year 2023.
On August 15, 2024, HHS announced the agreed-upon prices of the first ten drugs that were subject to price negotiations, although the Medicare Drug Price Negotiation program is currently subject to legal challenges. On January 17, 2025, HHS selected fifteen additional products covered under Part D for price negotiation in 2025.
Each year thereafter more Part B and Part D products will become subject to the Medicare Drug Price Negotiation Program. Further, on December 8, 2023, the National Institute of Standards and Technology published for comment a Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights which for the first time includes the price of a product as one factor an agency can use when deciding to exercise march-in rights. While march-in rights have not previously been exercised, it is uncertain if that will continue under the new framework. We expect that additional state and federal healthcare reform measures may be adopted in the future, any of which could limit the amounts that federal and state governments will pay for healthcare therapies. Additionally, such legislation, or similar regulatory changes, could put competitive pressure on our ability to profitably price our products, which, in turn, could adversely affect our business, results of operations, financial condition and prospects. It is also possible that other legislative proposals having similar effects will be adopted.
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Further, we cannot predict the likelihood, nature, or extent of healthcare reform initiatives that may arise from future legislation or administrative action, particularly given the recent change in administration. The current Trump administration is pursuing policies to reduce regulations and expenditures across government including at HHS, the FDA, CMS and related agencies. These actions, presently directed by executive orders or memoranda from the Office of Management and Budget, may propose policy changes that create additional uncertainty for our business. These actions may include, for example, directives to reduce agency workforce, rescinding a Biden administration executive order tasking the Center for Medicare and Medicaid Innovation to consider new payment and healthcare models to limit drug spending and eliminating the Biden administration’s executive order that directed HHS to establishing an AI task force and developing a strategic plan, and directing certain federal agencies to enforce existing law regarding hospital and price plan transparency and by standardizing prices across hospitals and health plans. Additionally, in its June 2024 decision in Loper Bright Enterprises v. Raimondo, the U.S. Supreme Court overturned the longstanding Chevron doctrine, under which courts were required to give deference to regulatory agencies’ reasonable interpretations of ambiguous federal statutes. The Loper Bright decision could result in additional legal challenges to current regulations and guidance issued by federal agencies applicable to our operations, including those issued by the FDA. Congress may introduce and ultimately pass health care related legislation that could impact the drug approval process and make changes to the Medicare Drug Price Negotiation Program created under the IRA. If we or any third parties we may engage are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we or such third parties are not able to maintain regulatory compliance, our drug candidates may lose any regulatory approval that may have been obtained and we may not achieve or sustain profitability.
Certain European countries utilize reference pricing to control the prices of drugs. Use of reference pricing may increase, which could restrict the sales potential for many new drugs unless the drug can be significantly differentiated from existing drugs.
Additional governmental and regulatory proposals and health care reforms are possible. However, we are unable to forecast what additional legislation or regulation relating to the health care industry or third-party reimbursement may be enacted in the future, or what effect such legislation or regulation would have on our business. Our business could be harmed by other health care reforms that may be erected or adopted in the future, and in particular this could have a material adverse effect on the amounts that private payors will pay for drugs. As a consequence, we may not be able to realize an appropriate return on our investment in research and development and generate revenue sufficient to attain profitability, even if our drugs are approved for marketing. This could have a material adverse effect on our business, financial condition, results of operations and prospects.
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The availability and level of third-party coverage and reimbursement for our potential drugs will be uncertain, and it may be difficult to obtain or maintain expected price levels.
Our or a partner’s ability successfully to commercialize our drug candidates and to attract strategic partners for our drug candidates or future drugs will depend in part on price levels and on the extent to which reimbursement for the costs of treatment with these drug candidates will be available from government health administration authorities, private health insurers and other third-party payors, as well as government health care programs. There is significant uncertainty related to third-party payor coverage and reimbursement of newly approved products. In the United States, for example, principal decisions about reimbursement for new products are typically made by CMS and private third-party payors often follow CMS’s decisions regarding coverage and reimbursement to a substantial degree. However, one third-party payor’s determination to provide coverage for a product candidate does not assure that other payors will also provide coverage for the drug candidate. Further, no uniform policy for coverage and reimbursement exists in the United States, and coverage and reimbursement can differ significantly from payor to payor. Further, coverage policies and third-party payor reimbursement rates may change at any time. Even if favorable coverage and reimbursement status is attained, less favorable coverage policies and reimbursement rates may be implemented in the future. Governments and other third-party payors are increasingly attempting to contain health care costs, in part by challenging the price of medical drugs and services or by restricting the eligibility for reimbursement. Health care cost pressure could lead to pricing pressure which could adversely affect pricing of GABAB PAM and our other potential drugs. Seeking third-party reimbursement is a time-consuming and costly process, which will require us and our partners to provide scientific and clinical support for the use of each of our drug candidates to each third-party payor separately. Significant uncertainty exists as to the payment status of newly approved medical drugs. The unavailability or inadequacy of third-party reimbursement, or legislation controlling treatments or prices, could have an adverse effect on the price level and consequently the market acceptance of our drug candidates and may have a material adverse effect on our results or operations, financial condition and prospects.
We are subject to U.S. and foreign anti-corruption laws and regulations, export and import controls, sanctions and embargoes. We could face liability and other serious consequences for violations which can harm our business.
We are subject to anti-corruption laws and regulations, including the U.S. Foreign Corrupt Practices Act of 1977, as amended, or FCPA, the U.S. domestic bribery statute contained in 18 U.S.C. § 201, the U.S. Travel Act and other state and national anti-bribery laws in the countries in which we may conduct activities in the future. Anti-corruption laws are interpreted broadly and generally prohibit companies and their employees, agents, contractors and other third-party collaborators from offering, promising, giving, or authorizing others to give anything of value, either directly or indirectly through third parties, to any person in the public or private sector to obtain or retain business. The FCPA also requires public companies to make and keep books and records that accurately and fairly reflect the transactions of the corporation and to devise and maintain an adequate system of internal accounting controls. We may engage third parties to sell our products or to obtain necessary permits, licenses, patent registrations, and other regulatory approvals outside the United States. We can be held liable for the corrupt or other illegal activities of our employees, agents, contractors, and other partners, even if we do not explicitly authorize or have actual knowledge of such activities. Any violation of the laws and regulations described above may result in substantial civil and criminal fines and penalties, imprisonment, the loss of export or import privileges, debarment, tax reassessments, breach of contract and fraud litigation, reputational harm, and other consequences.
We are also subject to export control and import laws and regulations, including the U.S. Export Administration Regulations, U.S. Customs regulations and various economic and trade sanctions regulations administered by the U.S. Treasury Department’s Office of Foreign Assets Controls. Compliance with applicable regulatory requirements regarding the export of our products may create delays in the introduction of our products in international markets or, in some cases, prevent the export of our products to some countries altogether. Furthermore, U.S. export control laws and economic sanctions prohibit the provision of certain products and services to countries, governments and persons targeted by U.S. sanctions.
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There is no certainty that all of our employees, agents, suppliers, manufacturers, contractors or collaborators, or those of our affiliates, will comply with all applicable anti-corruption, export and import control, and sanctions laws and regulations. Violations of these laws and regulations could result in fines, criminal sanctions against us, our officers, or our employees, the closing down of facilities, including those of our suppliers and manufacturers, requirements to obtain export licenses, cessation of business activities in sanctioned countries, implementation of compliance programs, and prohibitions on the conduct of our business. Any such violations could include prohibitions on our ability to offer our products in one or more countries as well as difficulties in manufacturing or continuing to develop our products, and could materially damage our reputation, our brand, our international expansion efforts, our ability to attract and retain employees, and our business, prospects, operating results and financial condition.
Any non-compliance by us with the environmental, health and safety laws and regulations that we are subject to could result in fines, suspension of drugs research and development or cessation of our operations or civil liability.
We are subject to a variety of health, safety and environmental laws and regulations in the jurisdictions in which we operate, particularly in our research and development activities, as well as in our pre-clinical studies. These laws and regulations govern, among other things, the use, storage, handling and discharge or disposal of hazardous materials, chemicals and compounds, including wastewater discharge, air emissions and waste management, where we operate. Our research and development programs involve the controlled use of hazardous materials, chemical and biological materials and controlled pre-clinical animal studies. Although we believe that we hold all permits currently required to operate our business and otherwise comply with current laws and regulations, any failure by us to comply with present or future laws and regulations could result in fines, suspension of research and development or cessation of our operations. We, like many of our competitors, have incurred, and will continue to incur, capital and operating expenditures and other costs in the ordinary course of our business in complying with such laws and regulations in most of the jurisdictions in which we operate. We do not currently anticipate any material additional capital expenditures in respect of such regulations outside of the ordinary course of our business. However, the risk of environmental liability is inherent in our business and there can be no assurance that additional material costs of complying with environmental regulations will not arise in the future. Our research and manufacturing activities involve the use of hazardous materials. Although we believe that our safety procedures for handling and disposing of hazardous materials (including medical and biological waste) comply with relevant laws and regulations, we cannot eliminate the risk of accidental or manmade contamination, injury or damage from these materials. In the event of an accident or environmental discharge, we may be held liable for any resulting damages. We cannot assure you that the amount of our insurance coverage will be sufficient to satisfy any such damages. As a result, any such accident could have a material adverse effect on our business, financial condition, results of operation and prospects. In addition, changes to existing or future laws and regulations may result in the imposition on us of significant additional environmental, health and safety compliance costs.
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We are exposed to currency fluctuation risks and other financial risks.
For the year ended December 31, 2024, approximately 29% and 23% of our costs and revenue, respectively, were denominated in currencies other than the Swiss franc. This proportion may significantly increase as we expand our operations. As a result, our business is affected by fluctuations in foreign exchange rates between the Swiss franc and other currencies. A significant amount of our costs is denominated in currencies other than Swiss francs, particularly U.S. dollars, Euros and British pounds, as we source supplies, research and development, consulting and other services in several countries other than Switzerland. Our revenue is mostly denominated in Swiss Francs for the twelve-month period ending December 31, 2024. Nevertheless, we expect to receive significant amounts from currencies other than Swiss francs in the medium and long term due to agreements with milestones payable in U.S dollars. Under our agreement with Indivior, all milestones payments and royalties payable by Indivior to us are denominated in U.S dollars. Since our reporting currency is the Swiss franc, we convert financial line items into Swiss francs at the applicable foreign exchange rates. We expect that a significant part of our costs will continue to be denominated in U.S. dollars, Euros or British pounds. We expect as well that a significant part of our revenue, including milestone payments and royalties, will be denominated in U.S. dollars in the medium and long term due to the agreement currently on force with Indivior. Unfavorable fluctuations in the value of the Swiss franc compared to these other currencies could have a material adverse effect on our business, financial condition, results of operations and prospects.
We are subject to risks related to data privacy concerns, cybersecurity breaches and failure to comply with privacy regulations and security requirements relating to data.
In the ordinary course of our business we come to possess sensitive personal data, including information from clinical trials, and health data obtained in connection with reporting of adverse events. We are subject to data protection laws, privacy requirements and other regulatory restrictions in the various jurisdictions in which we operate.
Our failure to keep apprised of, and comply with, privacy, data use and security laws, standards and regulations, including, for instance, unauthorized disclosure of, or access to, data, could result in the suspension or revocation of our approvals or registrations, the limitation, suspension or termination of services or the imposition of administrative, civil or criminal penalties, including fines which may be as high as €20 million or 4% of our annual worldwide revenue (whichever is greater) for serious infringements of the EU General Data Protection Regulation that became effective in May 2018. In addition, we may obtain health information from third parties in the United States (including research institutions from which we may obtain clinical trial data) that are subject to privacy and security requirements under the Health Insurance Portability and Accountability Act of 1996, as amended, or HIPAA. Depending on the facts and circumstances, we could be subject criminal penalties, including if we knowingly obtain, use, or disclose individually identifiable health information maintained by a HIPAA covered entity in a manner that is not authorized or permitted by, HIPAA. In addition, such failure or non-compliance may cause existing or potential partners, including hospitals, physicians and patients to cease interacting with us, and could damage our reputation and brand. In addition, to the extent more restrictive laws, rules or security requirements relating to business and personal data are adopted in the future in the various jurisdictions in which we operate, such changes could have an adverse impact on our business by increasing our costs or imposing restrictions on our business processes. Accordingly, our failure to keep apprised of, and comply with, privacy, data use and security laws, standards and regulations could have a material adverse effect on our reputation, business, financial condition, results and prospects. Our financial exposure to any actual or alleged breach of such regulations or standards may either not be insured against or not fully covered through our current insurance.
Cybersecurity attacks on our servers, information systems and databases, or the third-party servers, information systems and databases on which our information is stored, could compromise the security of our data or could cause interruptions in the operations of our businesses. Notwithstanding safeguards, cybersecurity breaches, internal security breaches, physical security breaches or other unauthorized or accidental access to our servers, other information systems or databases could result in tampering with, or the theft or publication of, sensitive information or the deletion or modification of data, or could otherwise cause interruptions in our operations.
The tampering with, disruption to, or the theft or publication of, sensitive information or the deletion or modification of records held either in our systems or the systems of others to which we have access, could subject us to increased costs and exposure to litigation. The loss of confidential information could result in the payment of damages and reputational harm and have a material adverse effect on our business, financial condition, results and prospects.
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Our financial exposure from the items referenced above could either not be insured against or not fully covered through any insurance that we maintain and could have a material adverse effect on our business, financial condition, results and prospects.
Risks Related to our ADSs and Shares
An investment in our securities is speculative, and there can be no assurance of any return on any such investment.
An investment in our securities is highly speculative, and there is no assurance that investors will obtain any return on their investment. Investors will be subject to substantial risks involved in their investment, including the risk of losing their entire investment.
The market price for our shares and ADSs may be highly volatile and could decline significantly.
Our securities have a relatively small public float and may be less liquid and more volatile than securities of companies with broader public ownership. Factors affecting the market price of the securities, many of which are beyond our control, include:
| ● | trading in our shares and ADSs, and securities derivative thereof; |
| ● | low daily trading volume of our securities on the SIX Swiss Exchange and/or on the Nasdaq Stock Market; |
| ● | announcements by us and developments that impact our financial results, business and partners; |
| ● | fluctuations in our financial position or operating results; |
| ● | changes in our business strategy and operations; |
| ● | changes in our senior management team or Board of Directors; |
| ● | commentary by investors on the prospects for our business, the shares or ADSs on the internet and/or social media and resulting in trading of our shares or ADSs; |
| ● | changes in the recommendations of securities analysts regarding us or our industry; |
| ● | unusual trading in our shares or ADSs or securities derivative thereof, including pursuant to naked, or uncovered, short positions; |
| ● | investor need for liquidity; |
| ● | investor assessment of the valuation of us and our competitors; |
| ● | fluctuations in interest rates; |
| ● | price and volume of the markets where our securities trade; and |
| ● | future offerings of our securities. |
In addition, securities markets in general have from time to time, and in particular in recent years, experienced significant price and volume fluctuations. Such fluctuations, as well as the economic environment as a whole, can have a substantial negative effect on the market price of our securities, regardless of our operating results or our financial position. Any such broad market fluctuations may adversely affect the trading price of our securities.
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Our ADSs may be delisted from Nasdaq which could negatively impact the price of our ADSs, our liquidity and our ability to access the capital markets.
Our ADSs are currently listed on Nasdaq under the symbol “ADXN.” The listing standards of Nasdaq provide that a company, in order to qualify for continued listing, must maintain a minimum bid price of USD 1.00 and satisfy standards relative to minimum shareholders’ equity, minimum market value of publicly held shares and various additional requirements. On May 18, 2023, we received a letter from the staff of Nasdaq notifying us that, for the previous 30 consecutive business days, the bid price for our ADSs had closed below the minimum USD 1.00 bid price requirement for continued listing on Nasdaq under Nasdaq Listing Rule 5550(a)(2). In order to regain compliance, the closing bid price of our ADSs have to meet or exceed USD1.00 per ADS for at least ten consecutive business days during the 180-calendar day grace period. In order to regain compliance, we effected the ADS Ratio Change, which went effective on October 23, 2023. On November 8, 2023, we announced that we had received a written notification from the staff of Nasdaq notifying us that we had regained compliance with the continued listing rule relating to the minimum bid price requirement of USD 1.00 per ADS. In the future, we may be subject to further written notifications from Nasdaq related to non-compliance with its continued listing rules. The ADS Ratio Change had the same effect as a one for twenty reverse ADS split. It cannot be assured that the ADS Ratio Change will result in any sustained proportionate increase in the market price of our ADSs, which is dependent upon many factors, including the business and financial performance of the company, general market conditions, and prospects for future success, which are unrelated to the number of our ADSs outstanding. It is not uncommon for the market price of a company’s ordinary shares to decline in the period following a reverse stock split.
If Nasdaq delists our securities from trading on its exchange for failure to meet the listing standards, we and our stockholders could face significant negative consequences including:
| ● | limited availability of market quotations for our securities; |
| ● | a determination that the ADSs are a “penny stock” which would require brokers trading in the ADSs to adhere to more stringent rules, possibly resulting in a reduced level of trading activity in the secondary trading market for the ADSs; |
| ● | a limited amount of analyst coverage, if any; and |
| ● | a decreased ability to issue additional securities or obtain additional financing in the future. |
Delisting from Nasdaq could also result in other negative consequences, including the potential loss of confidence by third parties such as institutional investors and fewer business development opportunities.
If our ADSs are delisted from Nasdaq, we believe that they may be eligible to be quoted on the inter- dealer electronic quotation and trading system operated by OTC Markets Group Inc., commonly referred to as the Pink Open Market and we may also qualify to be traded on their OTCQB market (The Venture Market). These markets are generally not considered to be as efficient as, and not as broad as, Nasdaq. Selling our ADSs on these markets could be more difficult because smaller quantities of ADSs would likely be bought and sold, and transactions could be delayed. In addition, in the event our ADSs are delisted, broker-dealers have certain regulatory burdens imposed upon them, which may discourage broker-dealers from effecting transactions in our ADSs or even holding our ADSs, further limiting the liquidity of our ADSs. These factors could result in lower prices and larger spreads in the bid and ask prices for our ADSs.
The value of our ADSs may be driven by the release of preclinical and clinical studies led by Neurosterix Group
On April 2, 2024, we sold a part of our business to Neurosterix and we received gross proceeds of CHF 5.0 million and a 20% equity interest in Neurosterix, an investment accounted for using the equity method. The value of this equity method investment on our balance sheet and the value of our ADSs may be driven by the success of failures or the preclinical and clinical studies led by Neurosterix.
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We expect to continue to incur significant costs as a result of operating as a company with securities listed in the United States in addition to Switzerland, and our senior management is required to devote substantial time to new compliance initiatives and corporate governance practices.
As a company with securities listed in the United States in addition to Switzerland, and particularly after we no longer qualify as an emerging growth company on December 31, 2025, we expect to continue to incur significant legal, accounting, and other expenses. The Sarbanes-Oxley Act of 2002, the Dodd-Frank Wall Street Reform and Consumer Protection Act, the listing requirements of Nasdaq and other applicable securities rules and regulations impose various requirements on non-U.S. reporting public companies, including the establishment and maintenance of effective disclosure and financial controls and corporate governance practices. Our senior management and other personnel will need to continue to devote a substantial amount of time to these compliance initiatives. Moreover, these rules and regulations increase our legal and financial compliance costs and make some activities more time-consuming and costly.
Pursuant to Section 404 of the Sarbanes-Oxley Act of 2002, or Section 404, we are required to furnish a report by our senior management on our internal control over financial reporting with our Annual Report to be filed with the SEC. However, for so long as we remain an emerging growth company until December 31, 2025, we will not be required to include an attestation report on internal control over financial reporting issued by our independent registered public accounting firm. To ensure compliance with Section 404, we will need to continue to dedicate internal resources, potentially engage outside consultants and adopt a detailed work plan to assess and document the adequacy of internal control over financial reporting, continue steps to improve control processes as appropriate, validate through testing that controls are functioning as documented, and implement a continuous reporting and improvement process for internal control over financial reporting. We anticipate that the process to document and evaluate our internal control over financial reporting will be both costly and challenging.
An active market may not develop or be sustained in which investors can resell ADSs.
Although our shares have traded on SIX since 2007 and ADSs representing our shares have traded on Nasdaq since January 29, 2020, we cannot predict the extent to which an active market for ADSs representing our shares will develop or be sustained on Nasdaq, or how the development of such a market might affect the market price for our shares on SIX and on Nasdaq. The price at which ADSs representing our shares trade on Nasdaq may or may not be correlated with the price at which our shares trade on SIX.
Fluctuations in the exchange rate between the U.S. dollar and the Swiss franc may increase the risk of holding the ADSs.
Our share price is quoted on SIX in Swiss francs, while the ADSs trade on Nasdaq in U.S. dollars. Fluctuations in the exchange rate between the U.S. dollar and the Swiss franc may result in temporary differences between the value of the ADSs and the value of our shares, which may result in heavy trading by investors seeking to exploit such differences. In addition, as a result of fluctuations in the exchange rate between the U.S. dollar and the Swiss franc, the U.S. dollar equivalent of the proceeds that a holder of the ADSs would receive upon the sale in Switzerland of any shares withdrawn from the depositary receipts facility, and the U.S. dollar equivalent of any cash dividends paid in Swiss francs on our shares represented by the ADSs, could also decline.
Future sales, or the possibility of future sales, of a substantial number of ADSs representing our shares or our shares could adversely affect the price of such securities.
Future sales of a substantial number of ADSs representing our shares or our shares, or the perception that such sales will occur, could cause a decline in the market price of ADSs representing our shares and our shares. As of December 31, 2024, we had 128,292,969 outstanding shares, including 56,061,527 treasury shares indirectly held through our wholly-owned subsidiary Addex Pharma SA. Of these 128,292,969 outstanding shares, 23,190,000 are in the form of 193,250 ADSs. All of our outstanding shares and ADSs representing our shares are freely tradeable on SIX and Nasdaq respectively. In addition, other than shares held by our affiliates, all such shares are able to be deposited with the depositary in exchange for ADSs representing such shares at the ratio referred to on the cover page of this Annual Report on Form 20-F, which ADSs will be freely tradeable. If holders sell substantial amounts of ADSs or shares in the respective public markets therefor, or if the market perceives that such sales may occur, the market price of ADSs representing our shares and our shares and our ability to raise capital through an issue of equity securities in the future could be, adversely affected. In addition, we may from time to time sell shares to the public, including pursuant to our sale agency agreement with Kepler Cheuvreux.
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We have never paid dividends on our share capital, and we do not anticipate paying cash dividends in the foreseeable future.
We have never declared or paid cash dividends on our share capital. We do not anticipate paying cash dividends on our registered shares in the foreseeable future. We currently intend to retain all available funds and any future earnings to fund the development and growth of our business. Any future determination to declare cash dividends will be made at the discretion of our board of directors, subject to compliance with applicable laws and covenants under current or future credit facilities, which may restrict or limit our ability to pay dividends and will depend on our financial condition, operating results, capital requirements, distributable profits and/or distributable reserves from capital contributions, general business conditions and other factors that our board of directors may deem relevant. As a result, capital appreciation, if any, of our securities will be your sole source of gain for the foreseeable future.
The exercise of equity incentive instruments granted under our equity incentive plan could dilute our share capital.
Pursuant to our existing equity incentive plan, employee stock option plan, or ESOP, and warrants may be exercisable at prices below the market price of our shares at the time of exercise. To the extent that these instruments are exercised in the future, holders of our registered shares will be diluted. As of December 31, 2024, there were 69,683,409 shares reserved for issuance pursuant to subscription rights outstanding under our existing equity incentive plan, including primarily 61,676,618 warrants and 8,006,791 shares reserved for the ESOP.
Holders of ADSs may not have the same voting rights as the holders of our shares and may not receive voting materials in time to be able to exercise their right to vote.
Holders of ADSs representing our shares are not able to exercise voting rights attaching to the underlying shares on an individual basis. Holders of ADSs representing our shares have appointed the depositary or its nominee as their representative to exercise the voting rights attaching to the shares underlying such ADSs. Holders of ADSs representing our shares may not receive voting materials in time to instruct the depositary to vote. The depositary may not be liable for any failure to carry out any instructions to vote, for the manner in which any vote is cast or for the effect of any such vote. As a result, holders of ADSs representing our shares may not be able to exercise voting rights and may lack recourse if such ADSs are not voted as requested. In addition, holders of ADSs representing our shares will not be able to call a shareholders’ meeting.
Holders of ADSs representing our shares may not receive distributions on our shares underlying our ADSs or any value for them if it is illegal or impractical to make them available to such holders.
The depositary for ADSs representing our shares has agreed to pay to holders of such ADSs cash dividends or other distributions that it or the custodian receives on our shares after deducting its fees and expenses. Holders of ADSs representing our shares will receive these distributions in proportion to the number of our shares underlying their ADSs. However, in accordance with the limitations set forth in the deposit agreement, it may be unlawful or impractical for the depositary to make a distribution available to holders of ADSs representing our shares. We have no obligation to take any other action to permit the distribution of ADSs representing our shares, shares themselves, rights or anything else to holders of ADSs representing our shares. This means that holders of ADSs representing our shares may not receive any distributions that we make on our shares or any value from them if it is unlawful or impractical to make such distributions available to holders. These restrictions may negatively impact the trading value of ADSs representing our shares.
Holders of ADSs may be subject to limitations on transfer of their ADSs.
ADSs are transferable on the books of the depositary. However, the depositary may close its transfer books at any time or from time to time when it deems expedient in connection with the performance of its duties. In addition, the depositary may refuse to deliver, transfer, or register transfers of ADSs generally when our books or the books of the depositary are closed, or at any time if we or the depositary deems it advisable to do so because of any requirement of law or of any government or governmental body, or under any provision of the deposit agreement, or for any other reason in accordance with the terms of the deposit agreement.
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ADSs holders may not be entitled to a jury trial with respect to claims arising under the deposit agreement, which could augur less favorable results to the plaintiff(s) in any such action.
The deposit agreement governing the ADSs representing our shares provides that holders and beneficial owners of ADSs irrevocably waive the right to a trial by jury in any legal proceeding arising out of or relating to the deposit agreement or the ADSs, including claims under federal securities laws, against us or the depositary to the fullest extent permitted by applicable law. If this jury trial waiver provision is prohibited by applicable law, an action could nevertheless proceed under the terms of the deposit agreement with a jury trial. To our knowledge, the enforceability of a jury trial waiver under the federal securities laws has not been finally adjudicated by a federal court. However, we believe that a jury trial waiver provision is generally enforceable under the laws of the State of New York, which govern the deposit agreement, by a court of the State of New York or a federal court, which have non-exclusive jurisdiction over matters arising under the deposit agreement, applying such law. In determining whether to enforce a jury trial waiver provision, New York courts and federal courts will consider whether the visibility of the jury trial waiver provision within the agreement is sufficiently prominent such that a party has knowingly waived any right to trial by jury. We believe that this is the case with respect to the deposit agreement and the ADSs. In addition, New York courts will not enforce a jury trial waiver provision in order to bar a viable setoff or counterclaim sounding in fraud or one which is based upon a creditor’s negligence in failing to liquidate collateral upon a guarantor’s demand, or in the case of an intentional tort claim (as opposed to a contract dispute), none of which we believe are applicable in the case of the deposit agreement or the ADSs. No condition, stipulation or provision of the deposit agreement or ADSs serves as a waiver by any holder or beneficial owner of ADSs or by us or the depositary of compliance with any provision of the federal securities laws. If you or any other holder or beneficial owner of ADSs brings a claim against us or the depositary in connection with matters arising under the deposit agreement or the ADSs, you or such other holder or beneficial owner may not be entitled to a jury trial with respect to such claims, which may have the effect of limiting and discouraging lawsuits against us and / or the depositary. If a lawsuit is brought against us and / or the depositary under the deposit agreement, it may be heard only by a judge or justice of the applicable trial court, which would be conducted according to different civil procedures and may augur different results than a trial by jury would have had, including results that could be less favorable to the plaintiff(s) in any such action, depending on, among other things, the nature of the claims, the judge or justice hearing such claims, and the venue of the hearing.
The rights accruing to holders of our shares may differ from the rights typically accruing to shareholders of a U.S. corporation.
We are organized under the law of Switzerland. The rights of holders of shares are governed by the laws of Switzerland and by our Articles of Association. These rights differ in certain respects from the rights of shareholders in typical U.S. corporations. See Exhibit 2.4 “Description of Securities”, which is incorporated by reference herein for a description of the principal differences between the provisions of Swiss law applicable to us and, the United States law applicable to shareholders.
Claims of U.S. civil liabilities may not be enforceable against us.
We are incorporated under the law of Switzerland. Certain of our directors reside outside the United States. As a result, it may not be possible for investors to effect service of process within the United States upon such persons or to enforce judgments obtained in U.S. courts against them or us, including judgments predicated upon the civil liability provisions of the U.S. federal securities laws. The United States and Switzerland do not currently have a treaty providing for recognition and enforcement of judgments (other than arbitration awards) in civil and commercial matters. Consequently, a final judgment for payment given by a court in the United States, whether or not predicated solely upon U.S. securities laws, would not automatically be recognized or enforceable in Switzerland. In addition, uncertainty exists as to whether Swiss courts would entertain original actions brought in Switzerland against us or our directors predicated upon the securities laws of the United States or any state in the United States. Any final and conclusive monetary judgment for a definite sum obtained against us in U.S. courts would be treated by the courts of Switzerland. Whether these requirements are met in respect of a judgment based upon the civil liability provisions of the U.S. securities laws, including whether the award of monetary damages under such laws would constitute a penalty, is an issue for the court making such decision. If a Swiss court gives judgment for the sum payable under a U.S. judgment, the Swiss judgment will be enforceable by methods generally available for this purpose. These methods generally permit the Swiss court discretion to prescribe the manner of enforcement. As a result, U.S. investors may not be able to enforce against us or certain of our directors, or certain experts named herein who are residents of Switzerland or countries other than the United States, any judgments obtained in U.S. courts in civil and commercial matters, including judgments under the U.S. federal securities laws.
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We are organized under the laws of Switzerland and our jurisdiction of incorporation is Plan-les-Ouates, Geneva, Switzerland. Moreover, a number of our directors and executive officers and a number of directors of each of our subsidiaries are not residents of the United States, and all or a substantial portion of the assets of such persons are located outside the United States. As a result, it may not be possible for investors to effect service of process within the United States upon us or upon such persons or to enforce against them judgments obtained in U.S. courts, including judgments in actions predicated upon the civil liability provisions of the federal securities laws of the United States. We have been advised by our Swiss counsel that there is doubt as to the enforceability in Switzerland of original actions, or in actions for enforcement of judgments of U.S. courts, of civil liabilities to the extent predicated upon the federal and state securities laws of the United States. Original actions against persons in Switzerland based solely upon the U.S. federal or state securities laws are governed, among other things, by the principles set forth in the Swiss Federal Act on International Private Law of 1987, as amended, or PILA. This statute provides that the application of provisions of non-Swiss law by the courts in Switzerland shall be precluded if the result was incompatible with Swiss public policy. Also, mandatory provisions of Swiss law may be applicable regardless of any other law that would otherwise apply.
Switzerland and the United States do not have a treaty providing for reciprocal recognition of and enforcement of judgments in civil and commercial matters. The recognition and enforcement of a judgment of the courts of the United States in Switzerland is governed by the principles set forth in the PILA. This statute provides in principle that a judgment rendered by a non-Swiss court may be enforced in Switzerland only if:
| ● | the non-Swiss court had jurisdiction pursuant to the PILA; |
| ● | the judgment of such non-Swiss court has become final and non-appealable; |
| ● | the judgment does not contravene Swiss public policy; |
| ● | the court procedures and the service of documents leading to the judgment were in accordance with the due process of law; and |
| ● | no proceeding involving the same position and the same subject matter was first brought in Switzerland, or adjudicated in Switzerland, or was earlier adjudicated in a third state and this decision is recognizable in Switzerland. |
We currently qualify as a foreign private issuer and, as a result, we are not subject to U.S. proxy rules and are subject to reporting obligations under the Exchange Act, that, to some extent, are more lenient and less frequent than those of a U.S. domestic public company.
We report under the Exchange Act as a non-U.S. company with foreign private issuer status. Because we qualify as a foreign private issuer under the Exchange Act, we are exempt from certain provisions of the Exchange Act that are applicable to U.S. domestic public companies, including (i) the sections of the Exchange Act regulating the solicitation of proxies, consents, or authorizations in respect of a security registered under the Exchange Act; (ii) the sections of the Exchange Act requiring insiders to file public reports of their stock ownership and trading activities and liability for insiders who profit from trades made in a short period of time; and (iii) the rules under the Exchange Act requiring the filing with the SEC of quarterly reports on Form 10-Q containing unaudited financial and other specified information or current reports on Form 8-K, upon the occurrence of specified significant events. In addition, foreign private issuers are not required to file their Annual Report on Form 20-F until 120 days after the end of each fiscal year, while U.S. domestic issuers that are accelerated filers are required to file their Annual Report on Form 10-K within 75 days after the end of each fiscal year. Foreign private issuers also are exempt from Regulation Fair Disclosure, aimed at preventing issuers from making selective disclosures of material information. As a result of the above, you may not have the same protections afforded to shareholders of companies that are not foreign private issuers.
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As a foreign private issuer and as permitted by the listing requirements of Nasdaq, we follow certain Swiss corporate governance rules instead of certain corporate governance requirements of Nasdaq.
As a foreign private issuer, we follow certain of our home country corporate governance rules instead of certain corporate governance requirements of Nasdaq. For example, we are exempt from Nasdaq regulations that require a listed U.S. company to:
| ● | have a majority of the board of directors consist of independent directors as such term is defined by Nasdaq; |
| ● | have nominating and compensations committees that are fully independent, as defined by Nasdaq; |
| ● | solicit proxies and provide proxy statements for all shareholder meetings; and |
| ● | seek shareholder approval for the implementation of certain equity compensation plans and issuances of shares. |
For an overview of our corporate governance principles, including those which comply with certain of the requirements above, see Exhibit 2.4 “Description of Securities”.
In accordance with our Nasdaq listing, our Audit Committee is required to comply with the provisions of Section 301 of the Sarbanes-Oxley Act of 2002 and Rule 10A-3 of the Exchange Act, both of which also are applicable to Nasdaq-listed U.S. companies. To the extent we determine to follow Swiss corporate governance practices instead of Nasdaq governance requirements applicable to domestic issuers, you may not have the same protections afforded to shareholders of companies that are subject to these Nasdaq requirements.
We may lose our foreign private issuer status, which would then require us to comply with the Exchange Act’s domestic reporting regime and Nasdaq’s corporate governance requirements applicable to a domestic issuer, and cause us to incur significant incremental legal, accounting and other expenses.
Although we currently qualify as a foreign private issuer, in order to maintain this status, as of each June either (a) a majority of our shares, including shares represented by ADSs, must be either directly or indirectly owned of record by non-residents of the United States or (b) (i) a majority of our executive officers or directors must not be U.S. citizens or residents, (ii) more than 50 percent of our assets must be located outside of the United States and (iii) our business must be administered principally outside of the United States. If we lose our status as a foreign private issuer, we would be required to comply with the Exchange Act reporting and other requirements applicable to U.S. domestic issuers, on January 1 of the succeeding year which are more detailed and extensive than the requirements for foreign private issuers. We would also be required to make changes in our corporate governance practices in accordance with various SEC and Nasdaq rules. The regulatory and compliance costs to us under U.S. securities laws if we are required to comply with the reporting requirements applicable to a U.S. domestic issuer will be significantly higher than the costs that we would incur as a foreign private issuer. As a result, we expect that the loss of foreign private issuer status would increase our legal and financial compliance costs and would make some activities highly time consuming and costly.
We are an “emerging growth company,” and we cannot be certain if the reduced reporting requirements applicable to “emerging growth companies” will make ADSs representing our shares or our shares less attractive to investors.
We are an “emerging growth company” as defined in the JOBS Act until December 31, 2025. For as long as we continue to be an emerging growth company, we may take advantage of exemptions from various reporting requirements that are applicable to other public companies that are not emerging growth companies, including not being required to comply with the auditor attestation requirements of Section 404, and, to the extent that we no longer qualify as a foreign private issuer, reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements and exemptions from the requirements of holding a nonbinding advisory vote on executive compensation including golden parachute compensation. We may take advantage of these exemptions until we are no longer an emerging growth company. We will remain an emerging growth company until the last day of the fiscal year ended December 31, 2025. As a result of our loss of emerging growth company status on December 31, 2025, it is possible that investors have found or will continue to find our ADSs less attractive in light of the fact that we have relied on certain of these exemptions.
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If some investors find our ADSs less attractive as a result, there may be a less active trading market for our ADSs and the price of our ADSs may be more volatile. We also expect that the loss of our emerging growth company status and compliance with these additional requirements will substantially increase our legal and financial compliance costs. In addition, any failure to comply with these additional requirements in a timely manner, or at all, could have an adverse effect on our business and results of operations and could cause a decline in the price of our ADSs.
If we fail to maintain an effective system of internal control over financial reporting, we may not be able to accurately report our financial results or prevent fraud. As a result, shareholders could lose confidence in our financial and other public reporting, which would harm our business and the trading price of ADSs representing our shares or our shares.
Effective internal controls over financial reporting are necessary for us to provide reliable financial reports and, together with adequate disclosure controls and procedures, are designed to prevent fraud. Any failure to implement required new or improved controls, or difficulties encountered in their implementation could cause us to fail to meet our reporting obligations. In addition, any testing by us conducted in connection with Section 404, or any subsequent testing by our independent registered public accounting firm, may reveal deficiencies in our internal controls over financial reporting that are deemed to be material weaknesses or that may require prospective or retroactive changes to our financial statements or identify other areas for further attention or improvement. Inadequate internal controls could also cause investors to lose confidence in our reported financial information, which could have a negative effect on the trading price of ADSs representing our shares or our shares.
Management has been required to assess the effectiveness of our internal controls annually beginning with our Annual Report filed in 2021. Our management has concluded that our internal control over financial reporting was not effective as of December 31, 2024 due to two material weaknesses identified during the preparation of our consolidated financial statements that were not initially fully compliant with IFRS Accounting Standards as described in item 15 “Disclosure controls and procedures”. Nevertheless, management believes that the consolidated financial statements and related financial information included in this Annual Report on Form 20-F fairly present in all material respects our financial condition, results of operations and cash flows as in conformity with IFRS Accounting Standards. As long as we are an “emerging growth company” under the JOBS Act, our independent registered public accounting firm will not be required to attest to the effectiveness of our internal controls over financial reporting pursuant to Section 404. An independent assessment of the effectiveness of our internal controls could detect problems that our management’s assessment might not. Undetected material weaknesses in our internal controls could lead to financial statement restatements requiring us to incur the expense of remediation and could also result in an adverse reaction in the financial markets due to a loss of confidence in the reliability of our financial statements.
If securities or industry analysts do not publish research, or publish inaccurate or unfavorable research, about our business, the price of ADSs representing our shares or our shares and the trading volume thereof could decline.
The trading market for ADSs representing our shares and our shares will depend in part on the research and reports that securities or industry analysts publish about us or our business. Since we did not undertake a primary offering of ADSs representing our shares in connection with the listing of ADSs on Nasdaq, we do not anticipate that many or any industry analysts in the United States will publish such research and reports in the United States about our shares or ADSs. If no or too few securities or industry analysts commence or continue coverage on us, the trading price for ADSs representing our shares and our shares could be affected. If one or more of the analysts who may eventually cover us downgrade such ADSs or shares or publish inaccurate or unfavorable research about our business, the trading price of ADSs representing our shares or our shares would likely decline. If one or more of these analysts cease coverage of us or fail to publish reports on us regularly, demand for ADSs representing our shares or our shares could decrease, which might cause the price of such securities and the trading volume thereof to decline.
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We have determined that we are a “passive foreign investment company,” or PFIC, for U.S. federal income tax purposes, for which the consequences to U.S. holders of our shares or ADSs representing our shares may be adverse.
Based on the nature and composition of our income, assets and activities for our taxable year ended December 31, 2024, we believe that we were classified as a PFIC for our taxable year ended December 31, 2024 and may be a PFIC in future taxable years. U.S. Holders should consult with their tax advisors regarding the implications of owning stock in a PFIC. However, because our PFIC status is subject to a number of uncertainties and the applicable law is subject to varying interpretations, neither we nor our tax advisors can provide any assurances with respect to our PFIC status for any prior, the current, or any future taxable year. Moreover, because the calculation of the value of our assets may be based in part on the value of our shares or ADSs, the value of which may fluctuate considerably, our PFIC status may change from year to year and is difficult to predict. A separate determination must be made after the close of each taxable year as to whether we are a PFIC for that year. As a result, our PFIC status may change from year to year and we have not yet made any determination as to our expected PFIC status for the current year. In addition, our U.S. counsel expresses no opinion with respect to our PFIC status for our taxable year ended December 31, 2024, our current or any other past or future taxable year. We intend to annually provide U.S. Holders (as defined below under the section titled “Taxation—Material U.S. Federal Income Tax Considerations for U.S. Holders” under Item 10.E.), upon request, a “PFIC Annual Information Statement”, with the information required to allow U.S. Holders to make a “qualified electing fund” election, or “QEF Election” for United States federal income tax purposes.
Under the Internal Revenue Code of 1986, as amended, a non-U.S. company will be considered a PFIC for any taxable year in which (1) 75% or more of its gross income consists of passive income or (2) 50% or more of the quarterly weighted average value of its assets consists of assets that produce, or are held for the production of, passive income. For purposes of these tests, passive income includes dividends, interest, gains from the sale or exchange of investment property and certain rents and royalties. In addition, for purposes of the above calculations, a non-U.S. corporation that directly or indirectly owns at least 25% by value of the shares of another corporation or partnership is treated as if it held its proportionate share of the assets and directly received its proportionate share of the income of such other corporation or partnership. If we are a PFIC for any taxable year during which a U.S. Holder holds our shares or ADSs representing our shares, we will continue to be treated as a PFIC with respect to such U.S. Holder in all succeeding years during which the U.S. Holder owns the shares or ADSs representing our shares, regardless of whether we continue to meet the PFIC test described above, unless the U.S. Holder makes a specified election once we cease to be a PFIC. If we are classified as a PFIC for any taxable year during which a U.S. Holder holds our shares or ADSs representing our shares, the U.S. Holder may be subject to adverse tax consequences regardless of whether we continue to qualify as a PFIC, including ineligibility for any preferred tax rates on capital gains or on actual or deemed dividends, interest charges on certain taxes treated as deferred, and additional reporting requirements. For further discussion of the PFIC rules and the adverse U.S. federal income tax consequences in the event we are classified as a PFIC, see the section titled “Taxation—Material U.S. Federal Income Tax Considerations for U.S. Holders.” under Item 10.E. Prospective U.S. Holders are strongly urged to consult their own tax advisors with respect to the impact of PFIC status on the purchase, ownership and disposition of our shares or ADSs, the consequences to them of an investment in a PFIC, any elections available with respect to our shares or ADSs and the IRS information reporting obligations with respect to the purchase, ownership and disposition of shares or ADSs of a PFIC.
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If a United States person is treated as owning at least 10% of our shares, such holder may be subject to adverse U.S. federal income tax consequences.
If a U.S. Holder is treated as owning, directly, indirectly or constructively, at least 10% of the value or voting power of our shares (directly or in the form of ADSs representing our shares), such U.S. Holder may be treated as a “United States shareholder” with respect to each “controlled foreign corporation” in our corporate group, if any. A controlled foreign corporation is any foreign corporation in which more than 50% of the total combined voting power of classes of voting stock or the total value of the corporation is owned (or treated as owned) by United States shareholders. If such group includes one or more U.S. subsidiaries, our non-U.S. subsidiaries will be treated as controlled foreign corporations, regardless of whether we are treated as a controlled foreign corporation. A United States shareholder of a controlled foreign corporation may be required to annually report and include in its U.S. taxable income its pro rata share of “Subpart F income,” “global intangible low-taxed income” and investments in U.S. property by controlled foreign corporations, regardless of whether we make any distributions. An individual that is a United States shareholder with respect to a controlled foreign corporation generally would not be allowed certain tax deductions or foreign tax credits that would be allowed to a United States shareholder that is a U.S. corporation. Failure to comply with these reporting obligations may subject a United States shareholder to significant monetary penalties and may prevent the statute of limitations with respect to such shareholder’s U.S. federal income tax return for the year for which reporting was due from starting. We cannot provide any assurances that we will assist our investors in determining whether any of our non-U.S. subsidiaries are treated as a controlled foreign corporation or whether such investor is treated as a United States shareholder with respect to any of such controlled foreign corporations. Further, we cannot provide any assurances that we will furnish to any United States shareholder information that may be necessary to comply with the reporting and tax paying obligations described in this risk factor. U.S. Holders should consult their tax advisors regarding the potential application of these rules to their investment in our shares or ADSs representing our shares.
Tax authorities may disagree with our positions and conclusions regarding certain tax positions, resulting in unanticipated costs, taxes or non-realization of expected benefits.
A tax authority may disagree with tax positions that we have taken, which could result in increased tax liabilities. A tax authority could assert that we are subject to tax in a jurisdiction where we believe we have not established a taxable connection, often referred to as a “permanent establishment” under international tax treaties, and such an assertion, if successful, could increase our expected tax liability in one or more jurisdictions. A tax authority may take the position that material income tax liabilities, interest and penalties are payable by us, in which case, we expect that we might contest such assessment. Contesting such an assessment may be lengthy and costly and if we were unsuccessful in disputing the assessment, the result could increase our anticipated effective tax rate.
Item 4. Information on the Company.
A. | History and Development of the Company |
Our legal and commercial name is Addex Therapeutics Ltd. We are a Swiss limited company organized under the laws of Switzerland. We were founded in 2002 with an indefinite duration. We are currently registered in Geneva, Switzerland. Our principal executive offices are located at Chemin des Mines 9, CH-1202 Geneva, Switzerland. Our telephone number is +41 884 1555. Investors should contact us for any inquiries through the address and telephone number of our principal executive office, or via our U.S. address at 1968 S Coast Hwy #1915, Laguna Beach, CA 92651. We maintain a website at www.addextherapeutics.com. The reference to our website is an inactive textual reference only and the information contained in, or that can be accessed through, our website is not a part of this Annual Report on Form 20-F. The SEC maintains an Internet site that contains reports and other information that we file electronically with the SEC at www.sec.gov.
Our actual capital expenditures for the years ended December 31, 2024, 2023, and 2022 were close to nil. These capital expenditures primarily related to investments in computers and software.
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B. | Business Overview |
Overview
We are a clinical-stage pharmaceutical company focused on the development of a portfolio of novel orally available small molecule drug candidates. Our business comprises of a pipeline of proprietary clinical and preclinical stage drug candidates that are being developed by our partners and internally. We or our partners are developing these clinical and preclinical stage proprietary drug candidates for diseases for which there are no approved therapies or where improved therapies are needed including post-stroke sensorimotor recovery, traumatic brain injury, or TBI, recovery, substance use disorder, or, SUD, and cough. We also hold a 20% equity interest in a spin out company, Neurosterix US Holdings LLC, a private company developing a portfolio of preclinical stage proprietary drug candidates for schizophrenia, mood disorders and cognition.
Our lead development compound is dipraglurant, a metabotropic glutamate receptor subtype 5 negative allosteric modulator, or mGlu5 NAM, currently under evaluation for future development in post-stroke/TBI recovery. On April 30, 2025, we announced entering into an option and collaboration agreement with Sinntaxis AB for an exclusive license to intellectual property covering the use of mGlu5 inhibitors for the treatment of brain injury recovery. The agreement also includes a research collaboration under which the Sinntaxis team will complete evaluation of dipraglurant for the treatment of brain injury recovery.
Our second development compound, ADX71149 is a novel orally active metabotropic glutamate receptor subtype 2 positive allosteric modulator, or mGlu2 PAM. On July 22, 2024, we announced that our Partner Janssen terminated the development of drug candidate ADX71149, because the Phase 2 study did not achieve statistical significance for the primary endpoint. On April 17, 2025, we announced that our partner Janssen terminated our partnership agreement and returned to us the program including all related intellectual property to the Group. We are currently evaluating the future development of ADX71149.
Our third development compound is GABAB PAM for chronic cough. In 2024, we completed a funded research program to discover novel gamma-aminobutyric acid subtype-b positive allosteric modulators, or GABAB PAMs, for Indivior PLC, or Indivior. Under the terms of the agreement with Indivior, we had the right to select GABAB PAM drug candidates for a number of reserved indications, including chronic cough. This target is clinically validated with baclofen, an orthosteric agonist of GABAB, used off label to treat chronic cough patients. However, baclofen’s use is limited by serious side-effects, short half-life and gradual loss of efficacy during chronic treatment. By more precisely targeting the GABAB receptor with a PAM we aim to have a best-in-class treatment with improved tolerability suitable for the chronic nature of this disease. This indication has a significant unmet medical need and represents a significant commercial opportunity. On August 27, 2024, Indivior selected a compound for future development in substance use disorder and undertakes all future development of their selected compound. Under the terms of the agreement, we have also exercised our right to select a compound to advance our own independent GABAB PAM program for the treatment of chronic cough. We are currently completing the preclinical evaluation of our selected compound.
We cannot forecast with any degree of certainty which proprietary products or indications, if any, will be subject to future collaborative arrangements, in whole or in part, and how such arrangements would affect our development plan or capital requirements. To date, we have secured grants and other funding from: The Michael J. Fox Foundation for Parkinson’s Research, or MJFF, for the development of dipraglurant for the treatment of PD-LID; the National Institute of Drug Abuse, or NIDA, to generate important data on the role of GABAB in substance use disorder and the Charcot-Marie-Tooth Association, or CMTA to evaluate the role of GABAB PAM compounds in preclinical models of CMT1A. As we advance our clinical and preclinical programs, we will continue to apply for subsidies, grants and government or agency sponsored studies that could offset or reduce our development costs.
The development and commercialization of drugs is highly competitive. We compete with a variety of multinational pharmaceutical companies and specialized pharmaceutical companies, including products approved for marketing and/or drug candidates under development, for each of the drug candidates and each of the indications for which we are developing. Furthermore, government authorities in the United States, at the federal, state and local levels, and in other countries, extensively regulate, among other things, the research, development, testing, manufacture, packaging, storage, recordkeeping, labeling, advertising, promotion, distribution, marketing, import and export of pharmaceutical products, such as those we are developing. The processes for obtaining regulatory approvals in the United States and in foreign countries, along with subsequent compliance with applicable statutes and regulations, require the expenditure of substantial time and financial resources.
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The Neurosterix Transaction
On April 2, 2024, we divested our allosteric modulator discovery platform and a portfolio of pre-clinical programs to a new Swiss company, Neurosterix Pharma Sàrl (equivalent to an LLC), focused on the discovery and development of novel orally available allosteric modulator drug candidates, including M4PAM for schizophrenia, mGlu7NAM for stress related disorders and mGlu2NAM for mild neurocognitive disorders. In connection with the Transaction, we received gross proceeds of CHF 5.0 million and a 20% equity interest in Neurosterix US Holdings LLC, the parent company of Neurosterix Pharma Sàrl. Neurosterix US Holdings LLC received USD 65.0 million (USD 62.5 million in April 2024 and USD 2.5 million in June 2024) in funding commitments from a syndicate of investors led by Perceptive Advisors.
The divestment of our discovery platform and early-stage programs included the transfer of the associated research and development staff, with a service agreement to allow key members of staff to support us in achieving our business strategy at zero cost for us. As of the date of the Transaction, all employees of the Group, other than our Head of Finance, became employees of Neurosterix Pharma Sàrl. Pursuant to the service agreement, certain former employees, including our Chief Executive Officer, dedicate a portion of their time to the Group.
Development Portfolio
Using our drug development expertise, we have established a portfolio of clinical and preclinical programs, internally and with partners.
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Partnered program
GABAB PAM for the treatment of substance use disorder. Our partner, Indivior, has licensed worldwide rights to our GABAB PAM program and is responsible for all development, manufacture and commercialization of any selected GABAB PAM drug candidates. Under the agreement, we were responsible for executing a research program funded by Indivior to discover novel drug candidates. Following the completion of the funded research program, Indivior selected a compound for future development in substance use disorders on August 27, 2024. On May 12, 2025, we announced that our Partner Indivior has successfully completed the IND enabling studies. We believe that substance use disorder is an indication with a significant commercial opportunity. Existing therapies often do not provide effective control of symptoms or have side effects that discourage adherence. Subject to regulatory approval, we believe that GABAB PAM may offer an innovative and differentiated treatment approach from existing therapies and provide significant benefit to patients.
Internally Developed Drug Candidates
Dipraglurant for post-stroke/TBI recovery. There is currently a large unmet need in post-stroke sensorimotor recovery as there are no drugs to support or enhance sensorimotor recovery, and current therapies rely on retraining and physiotherapy, with rehabilitation taking 6 months or more. Functional recovery by stimulating network connectivity in the brain has been demonstrated with dipraglurant which significantly restored functional control in animal studies. On April 30, 2025, we announced entering into an option and collaboration agreement with Sinntaxis AB for an exclusive license to intellectual property covering the use of mGlu5 inhibitors for the treatment of brain injury recovery. The agreement also includes a research collaboration under which the Sinntaxis team will complete evaluation of dipraglurant for the treatment of brain injury recovery. We are conducting further in vivo testing in stroke models, and subject to funding or securing a development partner, we plan to commence a Phase 2a clinical study.
ADX71149, mGlu2 PAM, indication under evaluation. Our drug candidate, ADX71149 is a novel orally active metabotropic glutamate receptor subtype 2 positive allosteric modulator, or mGlu2 PAM. On July 22, 2024, we announced that our Partner Janssen terminated the development of drug candidate ADX71149, because the Phase 2 study did not achieve statistical significance for the primary endpoint. On April 17, 2025, we announced that our partner Janssen terminated our partnership agreement and returned to us the program including all related intellectual property to the Group. We are currently evaluating the future development of ADX71149.
Internal Research Program
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GABAB PAM for the treatment and chronic cough. Our license agreement with Indivior provides for a funded research program, under which we have the right to select drug candidates for exclusive development in certain indications outside of SUD. We plan to develop our selected drug candidates in chronic cough, an indication that has been validated with baclofen, an orthosteric agonist of the GABAB receptor. We have demonstrated preclinical proof of concept of GABAB PAM in various in vivo models of cough and are in late clinical candidate selection phase. Subject to securing funding or a development partner, we plan to initiate IND enabling studies.
Spin out company – Neurosterix LLC
On April 2, 2024, we divested a part of our business to the spin out company Neurosterix. We received a cash consideration of CHF 5.0 million and a 20% equity interest in Neurosterix LLC, parent company of Neurosterix Group. The lead program is M4 PAM for Schizophrenia, currently completing IND enabling studies.
Introduction to Allosteric Modulation
Disease and the Role of Proteins
Proteins are complex biological molecules that have many structural and functional roles in the body. They are critical components in the lines of communication between the cells of the body known as signaling pathways. It is now recognized that signaling pathways are altered in many disease states through changes in the function of essential proteins underlying the series of cellular events required for normal biological activity. Most drug treatments are focused on modifying these biological signaling pathways by altering the activity profile of selected proteins suspected to play a key role in the manifestation of a particular disease. The major proteins targeted in drug discovery include membrane-bound receptors, such as G-protein coupled receptors, or GPCRs, or ionotropic (ion channels) receptors and enzymes.
GPCRs as Drug Targets
GPCRs are the largest family of integral membrane receptors, accounting for approximately 3-4% of the human genome. GPCRs have evolved to recognize a range of endogenous stimuli and act to transmit messages encoded in stimuli from the exterior to the interior of the cell. The ubiquitous cell surface distribution of GPCRs and their involvement in virtually all biological processes have made GPCRs extremely attractive targets for drug development. In fact, most currently marketed drugs act on GPCRs, emphasizing their importance for drug development.
Conventional Approaches to GPCR Drug Discovery
The drug discovery process involves the design of molecules that interact with a target with high specificity and efficacy. Traditional approaches to drug discovery focus on mimicking or inhibiting the actions of the endogenous activator for a target receptor. Conventionally, this has been done by the design and chemical synthesis of small molecule agonists (activators) or antagonists (inhibitors) that act in a competitive manner through interaction with the same binding site as the endogenous activator.
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Competitive agonists and antagonists must have a sufficiently high affinity for the target receptor to displace the endogenous activator and must be maintained at a sufficiently high concentration in the region of the receptor in order to exert an effect. Under these conditions, agonists will induce an activated state and antagonists will induce an inactivated state, and in both states, receptors will not be responsive to natural fluctuations in the levels of endogenous activator, thereby interfering with normal physiological signaling.
Although this approach has historically yielded a number of blockbuster drugs, such as Clopidogrel, or Plavix, Salmeterol, or Serevent, and Aripiprazole, or Abilify, significant challenges remain with respect to the continued development of therapeutically useful GPCR competitive agonists or antagonists due to either lack of receptor selectivity or undesirable side effects.
Allosteric Modulators as GPCR Drugs
In contrast to competitive orthosteric compounds, allosteric modulators of GPCRs interact with binding sites that are topographically distinct from the binding site of the endogenous activator, and therefore do not compete with the endogenous activator. This means that allosteric modulators do not activate or inhibit receptors on their own, but only in the presence of an endogenous activator do they enhance (positively modulate) or inhibit (negatively modulate) the natural physiological activity of the receptor. Consequently, allosteric modulators offer the possibility to preserve normal physiological receptor function while controlling pathologic activity caused by over- or under-activation of an endogenous receptor.
We believe that by applying this non-competitive allosteric modulator approach, we may be able to produce efficacious drug candidates with potentially beneficial properties:
| ● | Novel drug class: Allosteric modulators are a novel class of orally available small molecule drug candidates with chemical structures unrelated to that of competitive agonist or antagonist drugs and, as such, represent drug candidates with a high potential for composition of matter patent protection. |
| ● | Superior receptor sub-type selectivity: The binding site for an endogenous activator is in general, highly conserved within a GPCR family and achieving receptor subtype selectivity within a family has not always been possible for competitive agonists. The best examples of this are the muscarinic acetylcholine and the metabotropic glutamate receptor families, for which developing competitive, sub-type selective agonists have not been successful thus far. In contrast, allosteric modulator binding sites, being independent of endogenous stimuli, have evolved with a much higher structural diversity than endogenous activator binding sites and consequently offer the potential for the synthesis of drug candidates with much greater sub-type selectivity. |
| ● | Ability to discover small molecule drugs for a greater number of GPCR targets: Several GPCR targets are currently thought to be beyond the reach of conventional competitive drug discovery approaches due to the complexity of the interaction of the endogenous activator with the receptor; including, for example certain peptides, high molecular weight hormones and lipids. For these targets, the allosteric modulator approach represents a novel pathway to develop orally active activator or inhibitor small molecules. |
| ● | Ability to re-address well characterized and clinically validated GPCR targets where the pharmaceutical industry has exhausted competitive compound drug discovery approaches: Allosteric modulator drug candidates offer a promising way to revisit these targets, providing novel small molecules while capitalizing on the existing knowledge on well-validated GPCR targets. |
| ● | Improved safety: Allosteric modulators control pathologic activity while preserving natural physiological signaling activity due to their lack of effect in the absence of the endogenous activator. In addition, they show no or less tolerance to their effect when chronically administered, thereby not requiring increased dosing as is often the case with competitive compounds. Together with their superior selectivity, these allosteric modulator compounds have the potential for improved safety compared to their competitive analogs. |
| ● | Clinical use in combination: Given that allosteric modulators target different binding sites to conventional agonists or antagonists, allosteric modulator drugs may find clinical utility in combination therapies for certain clinical indications. |
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Orally available brain penetrant small molecule drug candidates that are highly selective for their therapeutic targets and interact with their target in a modulatory manner preserving natural physiological signaling are particularly suitable for chronic diseases such as neurological ones.
Competitive Positioning in Allosteric Modulation drug discovery
Since our inception in 2002, we have focused exclusively on allosteric modulation drug discovery and development and all our programs have been developed in house by leading experts in the field of allosteric modulation with years of experience in both industry and academia.
Our lead development compound, dipraglurant, an mGlu5 NAM, is being evaluated for development for post-stroke/TBI sensorimotor recovery and subject to funding or securing a development partner, we plan to commence a Phase 2a clinical study.
Our second development compound, ADX71149 is a novel orally active metabotropic glutamate receptor subtype 2 positive allosteric modulator, or mGlu2 PAM. On April 17, 2025, we announced that our partner Janssen terminated our partnership agreement and returned to us the program including all related intellectual property to the Group. We are currently evaluating the future development of ADX71149.
Our third development compound is a GABAB Program which has been licensed to Indivior. We have completed a research program funded by Indivior to discover novel GABAB PAM drug candidate and under the terms of the agreement, on August 27, 2024, Indivior selected a drug candidate for the substance use disorder indication whilst we select a drug candidate for our independent chronic cough program. On May 12, 2025, we announced that our partner Indivior has successfully completed the IND enabling studies of their drug candidate for the substance use disorders. Subject to securing funding or a development partner, we plan to initiate IND enabling studies of the drug candidate for the chronic cough indication.
Our Strategy
Since our inception through December 31, 2024, we have raised an aggregate of CHF 355.4 million in equity financing and generated an aggregate of CHF 66.8 million in revenue, which we have used to discover and develop our pipeline of drug candidates. We have also raised gross proceeds of CHF 5.0 million and acquired a 20% equity interest in Neurosterix US Holdings LLC as part of the Neurosterix Transaction executed on April 2, 2024. The key elements of our strategy include the following:
| ● | Continue to evaluate dipraglurant for post-stroke/TBI recovery. We are currently validating dipraglurant’s use in animal models of post-stroke recovery. We have drug product ready and subject to securing funding or a development partner, plan to initiate clinical studies; |
| ● | Evaluate new indications for ADX71149. We are currently evaluating a number of potential indications for ADX71149. We have drug product ready and subject to securing funding or collaborative arrangements, plan to initiate clinical studies; |
| ● | Continue to advance our GABAB PAM program. We completed a funded research program to discover novel GABAB PAM drug candidate for Indivior. As part of the research agreement, Indivior and us selected a drug compound for future development in substance use disorders and chronic cough, respectively. Our partner, Indivior, has successfully completed IND enabling studies for their drug candidate for the substance use disorders. Subject to securing funding or a development partner, we plan to initiate IND enabling studies of the drug candidate which we selected for our independent chronic cough program; |
| ● | Continue to pursue collaborative arrangements with pharmaceutical companies. We are seeking collaborative arrangements with third parties to advance the development and commercialization of our drug candidates. |
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Externally Developed Out-licensed Product Candidate
GABAB PAM for the treatment of substance use disorders, including alcohol use disorder
Our partner, Indivior, has licensed worldwide rights to our GABAB PAM program and is responsible for all development, manufacture and commercialization of any selected GABAB PAM drug candidates. Under the agreement, we completed a research program funded by Indivior to discover novel drug candidates. As part of this agreement, Indivior selected a drug candidate related to the substance use disorders indication including alcohol use disorder. We believe that substance use disorder is an indication with a significant commercial opportunity. Existing therapies often do not provide effective control of symptoms or have side effects that discourage adherence. Subject to regulatory approval, we believe that GABAB PAM may offer an innovative and differentiated treatment approach from existing therapies and may provide benefit to patients.
Scientific advances have revolutionized our understanding of addiction as a chronic, relapsing disease and not a moral failure. Drug addiction is a complex illness which is characterized by intense and, at times, uncontrollable drug craving, along with compulsive drug seeking and use that persist even in the face of devastating consequences. Addiction affects multiple brain circuits, including those involved in reward and motivation, learning and memory, and inhibitory control over behavior. While a person initially chooses to take drugs, over time the effects of prolonged exposure on brain functioning compromise the ability to choose, and seeking and consuming the drug become compulsive, often eluding a person’s self-control or willpower. Because drug abuse and addiction have so many dimensions and disrupt so many aspects of an individual’s life, treatment is not simple. Addiction treatment must help the individual stop using drugs, maintain a drug-free lifestyle, and achieve productive functioning in the family, at work and in society. Patients typically require long-term or repeated episodes of care to achieve the ultimate goal of sustained abstinence and recovery of their lives.
Alcohol Use Disorder, or AUD is a broad term for problems with alcohol, and is generally indicative of compulsive and uncontrolled consumption of alcoholic beverages. It is medically considered a disease, specifically an addictive illness. The World Health Organization estimates that about 140 million people throughout the world suffer from alcohol dependence. Patients with AUD suffer major changes to the brain structure and chemistry. Excessive alcohol consumption damages almost every organ in the body and the cumulative toxic effects can cause both medical (cirrhosis of the liver, pancreatitis, heart disease, peptic ulcers, sexual dysfunction) and psychiatric (epilepsy, dementia, psychosis, anxiety & depression) problems. Treatment of alcoholism is complex with current standard of care typically being prescribed to patients with heavy drinking but largely being unable to prevent them from relapsing. Approximately 5.8 percent or 14.4 million adults in the United States ages 18 and older had AUD in 2018. This includes 9.2 million men and 5.3 million women. In addition, an estimated 401,000 adolescents ages 12-17, in the United States, had AUD in 2018.
Indivior has completed IND enabling studies of their drug candidate for the substance use disorders and we expect them to file a regulatory application to start clinical studies.
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Our Internally Developed Product Candidates
ADX71149 – mGlu2 PAM
Our drug candidate, ADX71149 is a novel orally active metabotropic glutamate receptor subtype 2 positive allosteric modulator, or mGlu2 PAM. On April 17, 2025, we announced that our partner Janssen terminated our partnership agreement and returned to us the program including all related intellectual property to the Group. We are currently evaluating the future development of ADX71149.
Dipraglurant
Dipraglurant is a selective, orally active small molecule drug product which acts as an mGlu5 NAM. We discovered dipraglurant and hold composition of matter and polymorph patents granted in the United States, Europe and Japan. Dipraglurant is selective for mGlu5 and does not have significant activity or binding affinity to other mGlu or other CNS receptors, such as serotonin, GABA or dopamine receptors. There are currently no drugs of this class on the market. On April 30, 2025, we announced entering into an option and collaboration agreement with Sinntaxis AB for an exclusive license to intellectual property covering the use of mGlu5 inhibitors for the treatment of brain injury recovery. The agreement also includes a research collaboration under which the Sinntaxis team will complete evaluation of dipraglurant for the treatment of brain injury recovery. We are conducting further in vivo testing in stroke models, and subject to funding or securing a development partner, we plan to commence a Phase 2a clinical study.
Dipraglurant for post-stroke/TBI recovery
Globally more than 100 million people have survived an ischemic stroke and this number is increasing by 5.7 million per year. In the United States there are around 800,000 strokes of different severities per year, which can lead to motor paralysis, loss of sensory function, impaired autonomic functions such as bladder/bowel control, impaired cognition leading to deficits in communication, attention and memory, and often accompanied by pain.
There are currently no drugs to support sensorimotor recovery and current therapies rely on retraining and physiotherapy, with rehabilitation, often only partial, taking 6 months or more. In the meantime, patients may require assistance in routine tasks, personal care and daily living, increasing the burden of care and the risk of the onset of other comorbidities such as depression and social inadequacy.
Following stroke, focal lesions lead to neural tissue necrosis in confined areas and the brains modular organization is disrupted causing module segregation, leading to local imbalances in excitation/inhibition. mGlu5 receptors are widely expressed in medial prefrontal, somatosensory and motor cortices of the brain. mGlu5 modulates glutamatergic neurotransmission and is involved in plastic changes in neural circuits, interfering with neuroplasticity – a key mechanism in post-stroke sensorimotor recovery. The mGlu5 receptor is also involved in aberrant synaptogenesis and neural circuit reorganization associated with several neurological disorders, including stroke. By inhibiting mGlu5 receptors with a negative allosteric modulator (NAM), we aim to support cortical reorganization and formation of new functional pathways, restoring functional connectivity changes toward pre-lesion state and excitation/inhibition homeostasis in tandem with physiotherapy.
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Functional recovery by stimulating network connectivity in the brain has been demonstrated with MTEP (an mGlu5 NAM) and resulted in a significant motor recovery of functional control (Figure below)
Dipraglurant also significantly restored functional control in a shorter, 3-day experiment (Figure below).
We are conducting further in vivo testing and subject to funding or securing a development partner, plan to commence a Phase 2a study.
There is a large unmet need in post-stroke/TBI recovery, and we believe this innovative approach presents a significant commercial opportunity.
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Material Internal Research Programs
GABAB PAM
Activation of the GABAB, receptor, a Family C class of GPCR, is clinically and commercially validated. Generic GABAB receptor agonist, baclofen, also known as chlorophenibut, is marketed for spasticity and some spinal cord injuries, and used for overactive bladder, or OAB, but its wider use is limited due to a variety of side effects and short half-life. Researchers have shown that baclofen is effective in reducing drug self-administration, cravings, and anxiety, and thus promotes abstinence.
Our GABAB PAM drug candidates are novel, orally available, small molecules that have demonstrated positive effects and tolerability in several preclinical rodent models of pain, anxiety, addiction, cough and OAB. GABAB PAMs differ from the generic drug baclofen in that they are PAMs rather than orthosteric agonists at the GABAB receptor. The GABAB PAM only acts when the natural ligand (GABA) activates the receptor, and therefore respects the physiological cycle of activation. It has been proposed that PAMs produce fewer adverse effects and lead to less tolerance to effect than direct agonists (May and Christopoulos 2003; Langmead and Christopoulos 2006; Perdona et al. 2011; Urwyler 2011; Gjoni et al., 2008; Ahnaou et al).
GABAB PAM for the treatment of chronic cough
Our license agreement with Indivior provides for a funded research program, under which we have the right to select drug candidates for exclusive development in certain indications outside of substance use disorders, including chronic cough and pain. Chronic cough is a cough that lasts 8 weeks or more and does not respond to treatment for underlying cause or is unexplained. There are more that 18 million sufferers in the United States and Europe. In addition to the inconvenience of coughing potential complications can include, headaches, fainting, anxiety or depression, sleep loss, urine leakage, vomiting and muscle pain.
Current medications, including opioid drugs (codeine, morphine) and gabapentin/pregabalin deliver some relief, but their wider use is limited by side-effects and risk of abuse. Also, they are not recommended for children under 12. Current cough medications show limited or lack of effectiveness in 60% and 30% of patients, respectively. P2X3 inhibitors (gefapixant) have greater scope but still leave up to 25% of patients without any relief; in addition, discontinuation occurs due to gustatory side-effects.
Chronic cough is driven by hypersensitivity of the sensory C- and Aδ-fibers of the vagus nerve in combination with hypersensitivity of brain regions regulating cough. GABAB potentiators reduce cough by acting on GABAB receptors:
| ● | In the brain, in the regions regulating cough, including somatosensory cortex, thalamus, amygdala, solitary tract and paratrigeminal nuclei. |
| ● | In the periphery, on sensory endings of C-and Aδ-fibers, airway epithelium, lung smooth muscle cells and neutrophils, on cell bodies located in the jugular and nodose ganglia. |
This target is well-validated and supported by clinical and preclinical data. Baclofen (a GABAB agonist) is used off-label in patients with chronic cough. Also, baclofen showed efficacy in several clinical studies and in animal models of cough. However, centrally-mediated side-effects (nausea, sedation, dizziness), poor pharmacokinetic profile (short half-life) and tolerance following repeated administration limit its clinical use.
We are developing multiple chemical series of GABAB PAMs and have selected a drug candidate for development in refractory chronic cough. Subject to securing funding or a development partner, we expect to initiate IND enabling studies.
Material agreements
Collaboration Agreement with Indivior for Development of Novel GABAB PAM Compounds, including for the Treatment of Addiction and Other CNS Diseases
In January 2018, we entered into an agreement with Indivior for the discovery, development and commercialization of novel GABAB PAM compounds for the treatment of addiction and other CNS diseases. This agreement included the selected clinical candidate, ADX71441. In addition, Indivior agreed to fund a research program at Addex to discover novel GABAB PAM compounds.
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Indivior has sole responsibility, including funding liability, for development of selected compounds under the agreement through preclinical and clinical trials, as well as registration procedures and commercialization, if any, worldwide. Indivior has the right to design development programs for selected compounds under the agreement. Through our participation in a joint development committee, we review, in an advisory capacity, any development programs designed by Indivior. However, Indivior has authority over all aspects of the development of such selected compounds.
Under terms of the agreement, we have granted Indivior an exclusive license to use relevant patents and know-how in relation to the development and commercialization of drug candidates selected by Indivior. Subject to agreed conditions, Addex and Indivior jointly own all intellectual property rights that are jointly developed, and Addex or Indivior individually own all intellectual property rights that Addex or Indivior develop individually. Addex has retained the right to select compounds from the research program for further development in areas outside the interest of Indivior including chronic cough. Under certain conditions, but subject to certain consequences, Indivior may terminate the agreement.
In January 2018, under terms of the agreement, we received a non-refundable upfront fee of USD 5.0 million for the right to use the clinical candidate, ADX71441, including all materials and know-how related to this clinical candidate. On February 14, 2019, Indivior terminated the development of their selected compound, ADX71441.
Separately, Indivior funded research at Addex, based on a research plan to mutually agreed between the parties, to discover novel GABAB PAM compounds. These future novel GABAB PAM compounds, if selected by Indivior, become licensed compounds. We agreed with Indivior to an initial research term and duration of two years with a funding of USD 4.0 million over the period for our R&D costs incurred, that can be extended by twelve-month increments. Following Indivior’s selection of one newly identified compound, Addex has the right to also select one additional newly identified compound. Addex was responsible for the funding of all development and commercialization costs of its selected compounds and Indivior has no rights to the Addex selected compounds. The initial two-year research term ran from May 2018 to April 2020. In 2019, Indivior agreed to additional research funding of USD 1.6 million, and on October 30, 2020 the research term was extended until June 30, 2021 and Indivior agreed to further additional research funding of USD 2.8 million. Effective May 1, 2021, the research term was extended until July 31, 2022 and Indivior agreed additional research funding of CHF 3.7 million, of which CHF 2.7 million has been paid to us and CHF 1.0 million paid directly by Indivior to third party suppliers that are supporting the funded research program. In August 2022, the research agreement was extended until March 31, 2023 with additional research funding of CHF 0.85 million. The reserved indications, where Addex retains exclusive rights to develop its own independent GABAB PAM program, were also expanded to include chronic cough. Effective November 1, 2022 the research term was extended until June 30, 2023 and Indivior agreed to additional research funding of CHF 0.95 million. Effective July 1, 2023, the research term was extended until June 30, 2024 and Indivior agreed to additional research funding of CHF 2.7 million including CHF 1.1 million received directly by us and CHF 1.6 million paid directly by Indivior to third party suppliers that are supporting the funded research program.
On August 27, 2024, Indivior selected a compound for future development in substance use disorders and now undertake all future development of their selected compound. Under the terms of the agreement, we have also exercised our right to select a compound to advance our own independent GABAB PAM program for the treatment of chronic cough. Under the license agreement, we are as well eligible for payments on successful achievement of pre-specified clinical, regulatory and commercial milestones totaling USD 330 million. In addition, we are eligible for tiered royalties from high single digits to low double digits on net sales of applicable products on a country-by country-basis. The term of the royalty for each licensed product in any particular country commences on such product’s launch and ends on the latest of ten -year anniversary of launch, expiration of certain applicable patent rights, and expiration of certain applicable marketing or data exclusivity periods.
Indivior may terminate the Agreement in its entirety or with respect to one or more countries or products upon 90 days’ prior written notice prior to receipt of marketing approval for product candidates or twelve months’ prior written notice after the receipt of marketing approval.
Addex may terminate the agreement if Indivior commits a material breach of the agreement and fails to cure such breach within 90 days of Addex’s written notification to Indivior or fails to cure breaches to any payment obligations breach within 30 days, subject to certain conditions.
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Intellectual Property
Patents and Proprietary Rights
At the issuance date of this annual report on Form 20-F, we owned 9 U.S. and 130 foreign patents and a number of pending patent applications that cover several classes of compounds which are potentially useful as modulators of mGlu5, mGlu2 PAM and GABAB. More specifically, our patents and patent applications cover compounds, pharmaceutical compositions, polymorphs and uses of compounds for medical treatment.
Our patent strategy is to file patent applications on innovations and improvements to cover a majority of the major pharmaceutical markets in the world. We typically file priority applications at the United Kingdom Patent Office to establish a priority date for the generic subject matter and examples which are available at the filing date of each invention. Subsequently, we file international applications under the Patent Cooperation Treaty or PCT, with extra examples to support the scope of the claims (International Phase). After the International Phase, we file patent applications in selected countries representing potential major markets for our drug candidates (National/Regional Phase).
Generally, patents have a term of twenty years from the filing date, assuming all maintenance fees are paid. In some instances, patent terms can be increased or decreased, depending on the laws and regulations of the country or jurisdiction that issued the patent. Wherever appropriate and legally possible, we aim at obtaining patent protection for novel molecules, composition of matter and uses for drugs and inventions originating from our research and development efforts, as well as new manufacturing and other processes and formulations. In each case, we carefully balance the value of patent protection against the advantage of keeping the know-how regarding the invention confidential. We aim to position the claims of our applications to exploit gaps in prior art.
We have two patent families covering dipraglurant as a composition of matter and its polymorphs which are useful as mGlu5 NAMs: 74 patents have been granted to us, including 4 in the United States and 70 in other international jurisdictions (Austria, Belgium, Bulgaria, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Great Britain, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Macedonia, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland/Liechtenstein, Turkey, Australia, Brazil, Canada, China, Hong Kong, Indonesia, Israel, Japan, South Korea, Mexico, New Zealand, Philippines, Russia, Singapore, South Africa and Ukraine). We also have 3 patent applications pending.
We have one patent family covering compounds which are useful as GABAB PAMs, of which 7 patents have been granted, including 2 in the United States and 5 in other international jurisdictions (Austria, China, India, Israel and Japan).
We have 58 patents in two patent families covering compounds which are useful as mGlu2 PAMs, including ADX71149, which is explicitly exemplified and claimed as a compound and as a pharmaceutical composition, we have 3 patents in the United States and 55 in other international jurisdictions (Belgium, Bosnia & Herzegovina, Croatia, Cyprus, Czech Republic, France, Germany, Hungary, Italy, Lithuania, North Macedonia, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Switzerland/Liechtenstein, Turkey, Ukraine, United Kingdom, Algeria, Armenia, Argentina, Azerbaijan, Australia, Belarus, Brazil, Canada, China, Chile, Hong Kong, Israel, India, Indonesia, Japan, Kazakhstan, Republic of Korea, Kyrgyzstan, Malaysia, Mexico, Moldova, New Zealand, Philippines, Russia, Singapore, South Africa, Tajikistan, Thailand, Vietnam, and Taiwan).
Our portfolio of granted patents have expiry dates ranging from 2025 - 2034 without extension. Patent term extension of up to 5 years is available in some jurisdictions. For example, in the United States following the enactment of Title II of the Drug Price Competition and Patent Term Restoration Act (Public Law 98-417) it is generally possible to extend patent life by a maximum of 5 years.
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The patent positions of pharmaceutical and biotechnology companies are uncertain and involve complex legal and factual issues. There can be no assurance that patents that have been issued will be held valid and enforceable in a court of law. Even for patents that are held valid and enforceable, the legal process associated with obtaining such a judgment is time consuming and costly. Additionally, issued patents can be subject to opposition or other proceedings that can result in the revocation of the patent or maintenance of the patent in amended form, and potentially in a form that renders the patent without commercially relevant or broad coverage. Further, our competitors may be able to circumvent and otherwise design around our patents. Even if a patent is issued and enforceable, because development and commercialization of pharmaceutical products can be subject to substantial delays, patents may expire early and provide only a short period of protection, if any, following the commercialization of a product covered by any of our patents. We may have to participate in interference proceedings declared by the U.S. Patent and Trademark Office, which could result in a loss of the patent or substantial cost to us.
U.S. and foreign patent rights and other proprietary rights exist that are owned by third parties and relate to pharmaceutical compositions and reagents, medical devices and equipment and methods for preparation, packaging and delivery of pharmaceutical compositions. We cannot predict with any certainty which, if any, of these rights will be considered relevant to our technology by authorities in the various jurisdictions where such rights exist, nor can we predict with certainty which, if any, of these rights will or may be asserted against us by third parties. We could incur substantial costs in defending ourselves and our partners against any such claims. Furthermore, parties making such claims may be able to obtain injunctive or other equitable relief, which could effectively block our ability to develop or commercialize some or all of our products in the United States and abroad and could result in the award of substantial damages. In the event of a claim of infringement, we or our partners may be required to obtain one or more licenses from third parties. There can be no assurance that we can obtain a license to any technology that we determine we need on reasonable terms, if at all, or that we could develop or otherwise obtain alternative technology. The failure to obtain licenses if needed may have a material adverse effect on our business, results of operations and financial condition.
We also rely on trade secret protection for our confidential and proprietary information. No assurance can be given that we can meaningfully protect our trade secrets. Others may independently develop substantially equivalent confidential and proprietary information or otherwise gain access to, or disclose, our trade secrets. Our success will depend in part on our ability to obtain and maintain patent protection for our drugs, preserve trade secrets, prevent third parties from infringing upon our proprietary rights and operate without infringing upon the proprietary rights of others, both in Switzerland and in other territories worldwide.
It is our policy to require our employees and consultants, outside scientific collaborators, sponsored researchers and other advisors who receive confidential information from us to execute confidentiality agreements upon the commencement of employment or consulting relationships with us. These agreements provide that all confidential information developed or made known to the individual during the course of the individual’s relationship with us is to be kept confidential and not disclosed to third parties except in specific circumstances. The agreements provide that all inventions conceived by an employee shall be our property. There can be no assurance, however, that these agreements will provide meaningful protection or adequate remedies for our trade secrets in the event of unauthorized use or disclosure of such information.
Trademarks
We own trademarks for Addex Pharmaceuticals in Switzerland.
Competition
The development and commercialization of drugs is highly competitive. For each of the drug candidates and indications that we are pursuing, we compete with a variety of multinational and specialized pharmaceutical companies. This, includes products approved for marketing and/or drug candidates under development by our competitors which include:
Dipraglurant for post-stroke sensorimotor recovery
Therapies to improve patient motricity largely rely on physiotherapy and there are currently no drugs on the market to assist this process. There are currently 4 Phase 2a studies underway; Teva are testing armodafinil in combination with task-related training, Inserm are testing galantamine with cognitive rehabilitation, UCLA are testing Sinemet (L-DOPA) with the rehabilitation of the upper arm and KSA are testing L-DOPA with physiotherapy.
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GABAB PAM for the treatment of substance use disorders, including alcohol use disorder
Currently available treatments of addiction include Buprenorphine (Suboxone®, Subutex®, Probuphine®, Sublocade™), naltrexone (Vivitrol®) to treat opioid addiction; bupropion (Zyban®) and varenicline (Chantix®) to treat nicotine addiction; and naltrexone (Vivitrol®), Acamprosate (Campral®), Disulfiram (Antabuse®) to treat alcohol addiction. Baclofen (a GABAB agonist) has been largely used off-label to treat alcohol abuse, and its approval is under review in France. In addition, several novel derivatives of baclofen are in clinical development and Astellas is in Phase I with ASP8062 as a novel GABAB PAM for substance-related disorders.
GABAB PAM for the treatment of chronic cough
Current medications for chronic cough include opioid drugs (codeine, morphine), gabapentin (Horizant, Neurontin), pregabalin (Lyrica), dextromethorphan (Benylin, Broncophan, Robitussin), guaifenesin (Mucinex, Bidex, Organidin). However, they suffer from limitations of use due to many side effects including abuse potential, drowsiness, GI dysfunction. Their antitussive effectiveness is lacking in large portion of patients, and most are not recommended for children under 12.
Recently, new classes of agents have demonstrated efficacy in clinical trials, including purinergic P2X3 receptor and neurokinin-1 receptor inhibitors. The P2X3 antagonist, gefapixant, is the first molecule approved in Japan and Europe for the treatment for refractory and unexplained chronic cough in adults. However, while having greater scope, gefapixant still leaves up to 25% of patients without any relief and treatment discontinuation occurs due to gustatory side-effects.
Baclofen, the GABAB orthosteric agonist, has been used off-label to treat GERD-related chronic cough, but also cough caused by angiotensin-converting enzyme inhibitors and chronic refractory cough of unknown cause.
United States Government Regulation and Product Approval
Government authorities in the United States, at the federal, state and local levels, and in other countries, extensively regulate, among other things, the research, development, testing, manufacture, packaging, storage, recordkeeping, labeling, advertising, promotion, distribution, marketing, import and export of pharmaceutical products, such as those we are developing. The processes for obtaining regulatory approvals in the United States and in foreign countries, along with subsequent compliance with applicable statutes and regulations, require the expenditure of substantial time and financial resources.
Marketing
In the United States, the FDA regulates drugs under the Federal Food, Drug, and Cosmetic Act, (FDCA), and its implementing regulations. The process of obtaining regulatory approvals and the subsequent compliance with appropriate federal, state, local and foreign statutes and regulations requires the expenditure of substantial time and financial resources. Failure to comply with the applicable United States requirements at any time during the drug development process, approval process or after approval, may subject an applicant to a variety of administrative or judicial sanctions, such as the FDA’s refusal to approve pending new drug applications, or NDAs, withdrawal of an approval, imposition of a clinical hold, issuance of warning or untitled letters, product recalls, product seizures, total or partial suspension of production or distribution, injunctions, fines, refusals of government contracts, restitution, disgorgement or civil or criminal penalties.
The process required by the FDA before a drug may be marketed in the United States generally involves:
| ● | completion of pre-clinical laboratory tests, animal studies and formulation studies in compliance with the FDA’s good laboratory practice, or GLP, regulations, including laboratory evaluation of product chemistry, toxicity and formulation, as well as animal studies to assess potential safety and efficacy; |
| ● | submission to the FDA of an Investigational New Drug, or IND, which must become effective before human clinical trials may begin; |
| ● | approval by an independent institutional review board, or IRB, at each clinical site before each clinical trial may be initiated; |
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| ● | performance of adequate and well-controlled clinical trials in accordance with good clinical practice, or GCP, requirements to establish the safety and efficacy of the proposed drug for each indication; |
| ● | submission to the FDA of an NDA; |
| ● | satisfactory completion of an FDA advisory committee review, if applicable; |
| ● | satisfactory completion of an FDA inspection of the manufacturing facility or facilities at which the product is produced to assess compliance with cGMP requirements, and to assure that the facilities, methods and controls are adequate to preserve the drug’s identity, strength, quality and purity; satisfactory completion of an FDA inspection of selected clinical sites to assure compliance with GCPs and the integrity of the clinical data; payment of user fees; and |
| ● | FDA review and approval of the NDA. |
Clinical Trials
Prior to the initiation of clinical testing, a sponsor must submit to the FDA an IND, application to the FDA, including the results of pre-clinical studies, manufacturing information, analytical data and any available clinical data or literature. Some pre-clinical testing may continue even after the IND is submitted. An IND automatically becomes effective 30 days after receipt by the FDA, unless before that time the FDA raises concerns or questions related to one or more proposed clinical trials and places the clinical trial on a clinical hold. In such a case, the IND sponsor and the FDA must resolve any outstanding concerns before the clinical trial can begin. As a result, submission of an IND may not result in the FDA allowing clinical trials to commence.
Clinical trials involve the administration of the investigational new drug to human subjects under the supervision of qualified investigators in accordance with GCP requirements, which include the requirement that all research subjects provide their informed consent in writing for their participation in any clinical trial. Clinical trials are conducted under protocols detailing, among other things, the objectives of the trial, the parameters to be used in monitoring safety and the effectiveness criteria to be evaluated. A protocol for each clinical trial and any subsequent protocol amendments must be submitted to the FDA as part of the IND. In addition, an IRB at each institution participating in the clinical trial must review and approve the plan for any clinical trial before it commences at that institution, and the IRB must continue to oversee the clinical trial while it is being conducted. Information about certain clinical trials must be submitted within specific timeframes to the National Institutes of Health, or NIH, for public dissemination on their ClinicalTrials.gov website.
Human clinical trials are typically conducted in three sequential phases, which may overlap or be combined. In Phase 1, the drug is initially introduced into healthy human subjects or patients with the target disease or condition and tested for safety, dosage tolerance, absorption, metabolism, distribution, excretion and, if possible, to gain an initial indication of its effectiveness. In Phase 2, the drug typically is administered to a limited patient population to identify possible adverse effects and safety risks, to preliminarily evaluate the efficacy of the product for specific targeted diseases and to determine dosage tolerance and optimal dosage. In Phase 3, the drug is administered to an expanded patient population, generally at geographically dispersed clinical trial sites, in well-controlled clinical trials to generate enough data to statistically evaluate the safety and efficacy of the product for approval, to establish the overall risk-benefit profile of the product and to provide adequate information for the labeling of the product.
Progress reports detailing the results of the clinical trials must be submitted, at least annually, to the FDA, and more frequently if certain serious adverse events occur. Phase 1, Phase 2 and Phase 3 clinical trials may not be completed successfully within any specified period, or at all. Furthermore, the FDA or the sponsor may suspend or terminate a clinical trial at any time on various grounds, including a finding that the research subjects are being exposed to an unacceptable health risk. Similarly, an IRB can suspend or terminate approval of a clinical trial at its institution if the clinical trial is not being conducted in accordance with the IRB’s requirements, or if the drug has been associated with unexpected serious harm to patients.
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Marketing Approval
Assuming successful completion of the required clinical testing, the results of the pre-clinical and clinical studies, together with detailed information relating to the product’s chemistry, manufacture, controls and proposed labeling, among other things, are submitted to the FDA as part of an NDA requesting approval to market the product for one or more indications. In most cases, the submission of an NDA is subject to a substantial application user fee. Under the Prescription Drug User Fee Act, or PDUFA, guidelines that are currently in effect, the FDA has a goal of ten months from the date of “filing” of a standard NDA for a new molecular entity to review and act on the submission. This review typically takes twelve months from the date the NDA is submitted to the FDA because the FDA has sixty days from submission to make a “filing” decision.
In addition, under the Pediatric Research Equity Act, certain NDAs or supplements to an NDA must contain data that are adequate to assess the safety and effectiveness of the drug for the claimed indications in all relevant pediatric subpopulations, and to support dosing and administration for each pediatric subpopulation for which the product is safe and effective. The FDA may, on its own initiative or at the request of the applicant, grant deferrals for submission of some or all pediatric data until after approval of the product for use in adults, or full or partial waivers from the pediatric data requirements. Unless otherwise required by regulation, the pediatric data requirements do not apply to products with orphan designation.
The FDA also may require submission of a risk evaluation and mitigation strategy, or REMS, plan to ensure that the benefits of the drug outweigh its risks. The REMS plan could include medication guides, physician communication plans, assessment plans, and / or elements to assure safe use, such as restricted distribution methods, patient registries or other risk minimization tools.
The FDA conducts a preliminary review of all NDAs within the first 60 days after submission, before accepting them for filing, to determine whether they are sufficiently complete to permit substantive review. The FDA may request additional information rather than accept an NDA for filing. In this event, the application must be resubmitted with the additional information. The resubmitted application is also subject to review before the FDA accepts it for filing. Once the submission is accepted for filing, the FDA begins an in-depth substantive review. The FDA reviews an NDA to determine, among other things, whether the drug is safe and effective and whether the facility in which it is manufactured, processed, packaged or held meets standards designed to assure the product’s continued safety, quality and purity.
The FDA may refer an application for a novel drug to an advisory committee. An advisory committee is a panel of independent experts, including clinicians and other scientific experts, that reviews, evaluates and provides a recommendation as to whether the application should be approved and under what conditions. The FDA is not bound by the recommendations of an advisory committee, but it considers such recommendations carefully when making decisions.
Before approving an NDA, the FDA typically will inspect the facility or facilities where the product is manufactured. The FDA will not approve an application unless it determines that the manufacturing processes and facilities are in compliance with cGMP requirements and adequate to assure consistent production of the product within required specifications. Additionally, before approving an NDA, the FDA will typically inspect one or more clinical trial sites to assure compliance with GCP requirements.
The testing and approval process for an NDA requires substantial time, effort and financial resources, and takes several years to complete. Data obtained from pre-clinical and clinical testing are not always conclusive and may be susceptible to varying interpretations, which could delay, limit or prevent regulatory approval. The FDA may not grant approval of an NDA on a timely basis, or at all.
After evaluating the NDA and all related information, including the advisory committee recommendation, if any, and inspection reports regarding the manufacturing facilities and clinical trial sites, the FDA may issue an approval letter, or, in some cases, a complete response letter. A complete response letter generally contains a statement of specific conditions that must be met in order to secure final approval of the NDA and may require additional clinical or pre-clinical testing in order for FDA to reconsider the application. Even with submission of this additional information, the FDA ultimately may decide that the application does not satisfy the regulatory criteria for approval. If and when those conditions have been met to the FDA’s satisfaction, the FDA will typically issue an approval letter. An approval letter authorizes commercial marketing of the drug with specific prescribing information for specific indications.
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Even if the FDA approves a product, it may limit the approved indications for use of the product, require that contraindications, warnings or precautions be included in the product labeling, require that post-approval studies, including Phase 4 clinical trials, be conducted to further assess a drug’s safety after approval, require testing and surveillance programs to monitor the product after commercialization, or impose other conditions, including distribution and use restrictions or other risk management mechanisms under a REMS, which can materially affect the potential market and profitability of the product. The FDA may prevent or limit further marketing of a product based on the results of post-marketing studies or surveillance programs. After approval, some types of changes to the approved product, such as adding new indications, manufacturing changes, and additional labeling claims, are subject to further testing requirements and FDA review and approval.
Orange Book Listing
In seeking approval for a drug through an NDA, applicants are required to list with the FDA certain patents whose claims cover the applicant’s product. Upon approval of an NDA, each of the patents listed in the application for the drug is then published in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations, known as the Orange Book. Any applicant who files an Abbreviated New Drug Application, or ANDA, seeking approval of a generic equivalent version of a drug listed in the Orange Book referencing a drug listed in the Orange Book must certify, for each patent listed in the Orange Book for the referenced drug, to the FDA that (1) no patent information on the drug product that is the subject of the application has been submitted to the FDA, (2) such patent has expired, (3) the date on which such patent expires or (4) such patent is invalid or will not be infringed upon by the manufacture, use or sale of the drug product for which the application is submitted. The fourth certification described above is known as a paragraph IV certification. A notice of the paragraph IV certification must be provided to each owner of the patent that is the subject of the certification and to the holder of the approved NDA to which the ANDA. The applicant may also elect to submit a “section viii” statement certifying that its proposed label does not contain (or carves out) any language regarding the patented method-of-use rather than certify to a listed method-of-use patent. This section viii statement does not require notice to the patent holder or NDA owner. There might also be no relevant patent certification.
If the reference NDA holder and patent owners assert a patent challenge directed to one of the Orange Book listed patents within 45 days of the receipt of the paragraph IV certification notice, the FDA is prohibited from approving the application until the earlier of 30 months from the receipt of the paragraph IV certification expiration of the patent, settlement of the lawsuit, or a decision in the infringement case that is favorable to the applicant. Even if the 45 days expire, a patent infringement lawsuit can be brought and could delay market entry, but it would not extend the FDA-related 30-month stay of approval.
Post-Approval Requirements
Drugs manufactured or distributed pursuant to FDA approvals are subject to pervasive and continuing regulation by the FDA, including, among other things, requirements relating to recordkeeping, periodic reporting, product sampling and distribution, advertising and promotion and reporting of adverse experiences with the product. After approval, most changes to the approved product, such as adding new indications, manufacturing changes or other labeling claims, are subject to further testing requirements and prior FDA review and approval. There also are continuing annual user fee requirements for any marketed products and the establishments at which such products are manufactured, as well as application fees for supplemental applications with clinical data.
Even if the FDA approves a product, it may limit the approved indications for use of the product, require that contraindications, warnings or precautions be included in the product labeling, including a boxed warning, require that post-approval studies, including Phase 4 clinical trials, be conducted to further assess a drug’s safety after approval, require testing and surveillance programs to monitor the product after commercialization, or impose other conditions, including distribution restrictions or other risk management mechanisms under a REMS, which can materially affect the potential market and profitability of the product. The FDA may prevent or limit further marketing of a product based on the results of post-marketing studies or surveillance programs.
In addition, drug manufacturers and other entities involved in the manufacture and distribution of approved drugs are required to register their establishments with the FDA and state agencies, and are subject to periodic unannounced inspections by the FDA and these state agencies for compliance with cGMP requirements. Changes to the manufacturing process are strictly regulated and often require prior FDA approval before being implemented. FDA regulations also require investigation and correction of any deviations from cGMP and impose reporting and documentation requirements upon the sponsor and any third party manufacturers that the sponsor may decide to use. Accordingly, manufacturers must continue to expend time, money and effort in the area of production and quality control to maintain cGMP compliance.
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Once an approval is granted, the FDA may withdraw the approval if compliance with regulatory requirements and standards is not maintained or if problems occur after the product reaches the market. Later discovery of previously unknown problems with a product, including adverse events of unanticipated severity or frequency, or with manufacturing processes, or failure to comply with regulatory requirements, may result in mandatory revisions to the approved labeling to add new safety information; imposition of post-market studies or clinical trials to assess new safety risks; or imposition of distribution or other restrictions under a REMS program. Other potential consequences include, among other things:
| ● | restrictions on the marketing or manufacturing of the product, complete withdrawal of the product from the market or product recalls; |
| ● | fines, warning letters or holds on post-approval clinical trials; |
| ● | refusal of the FDA to approve pending NDAs or supplements to approved NDAs, or suspension or revocation of product approvals; |
| ● | product seizure or detention, or refusal to permit the import or export of products; or |
| ● | injunctions or the imposition of civil or criminal penalties. |
The FDA strictly regulates marketing, labeling, advertising and promotion of products that are placed on the market. Drugs may be promoted only for the approved indications and in accordance with the provisions of the approved label, although physicians, in the practice of medicine, may prescribe approved drugs for unapproved indications. The FDA and other agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses, and a company that is found to have improperly promoted off-label uses may be subject to liability.
In addition, the distribution of prescription pharmaceutical products is subject to the Prescription Drug Marketing Act, or PDMA, which regulates the distribution of drugs and drug samples at the federal level, and sets minimum standards for the registration and regulation of drug distributors by the states. Both the PDMA and state laws limit the distribution of prescription pharmaceutical product samples and impose requirements to ensure accountability in distribution.
United States Federal and State Fraud and Abuse, Data Privacy and Security, and Transparency Laws and Regulations
In addition to FDA restrictions on marketing of pharmaceutical products, federal and state healthcare laws and regulations restrict business practices in the biopharmaceutical industry. These laws may impact, among other things, our current and future business operations, including our clinical research activities, and proposed sales, marketing and education programs and constrain the business or financial arrangements and relationships with healthcare providers and other parties through which we market, sell and distribute our products for which we obtain marketing approval. These laws include anti-kickback and false claims laws and regulations, data privacy and security, and transparency laws and regulations, including, without limitation, those laws described below.
The federal Anti-Kickback Statute prohibits, among other things, individuals or entities from knowingly and willfully offering, paying, soliciting or receiving remuneration, directly or indirectly, overtly or covertly, in cash or in kind to induce or in return for purchasing, leasing, ordering or arranging for or recommending the purchase, lease or order of any item or service reimbursable under Medicare, Medicaid or other federal healthcare programs. The term “remuneration” has been broadly interpreted to include anything of value. The federal Anti-Kickback Statute has been interpreted to apply to arrangements between pharmaceutical manufacturers on one hand and prescribers, purchasers and formulary managers on the other hand. Although there are a number of statutory exceptions and regulatory safe harbors protecting some common activities from prosecution, the exceptions and safe harbors are drawn narrowly. Practices that involve remuneration that may be alleged to be intended to induce prescribing, purchases or recommendations may be subject to scrutiny if they do not qualify for an exception or safe harbor.
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The reach of the federal Anti-Kickback Statute was also broadened by the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010, or collectively the ACA, which, among other things, amended the intent requirement of the federal Anti-Kickback Statute such that a person or entity no longer needs to have actual knowledge of this statute or specific intent to violate it in order to have committed a violation. In addition, the ACA provides that the government may assert that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the False Claims Act and the civil monetary penalties statute.
The federal civil and criminal false claims laws, including the False Claims Act, which prohibit, among other things, any individual or entity from knowingly presenting, or causing to be presented, a false claim for payment to the federal government or knowingly making, using or causing to be made or used a false record or statement material to a false or fraudulent claim to the federal government. A claim includes “any request or demand” for money or property presented to the U.S. government. Numerous pharmaceutical and other healthcare companies have been prosecuted under these laws for, among other things, allegedly providing free product to customers with the expectation that the customers would bill federal programs for the product and for causing false claims to be submitted because of the companies’ marketing of products for unapproved, and thus non-reimbursable, uses.
The federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, created additional federal criminal statutes that prohibit, among other things, knowingly and willfully executing a scheme to defraud any healthcare benefit program, including private third party payors and knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statement in connection with the delivery of or payment for healthcare benefits, items or services. Similar to the federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation.
HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, or HITECH, and their respective implementing regulations, impose certain requirements relating to the privacy, security and transmission of individually identifiable health information without appropriate authorization on certain health plans, healthcare clearinghouses and certain healthcare providers, known as covered entities, and their respective business associates, independent contractors that perform certain services involving the use or disclosure of individually identifiable health information as well as their covered subcontractors. HITECH also created new tiers of civil monetary penalties, amended HIPAA to make civil and criminal penalties directly applicable to business associates, and gave state attorneys general new authority to file civil actions for damages or injunctions in federal courts to enforce HIPAA and seek attorneys’ fees and costs associated with pursuing federal civil actions.
The federal Physician Payments Sunshine Act requires certain manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program, with specific exceptions, to report annually to the Centers for Medicare & Medicaid Services, or CMS, information related to payments or other transfers of value made to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors), other healthcare professionals (such as physician assistants and nurse practitioners), and teaching hospitals, and applicable manufacturers and applicable group purchasing organizations to report annually to CMS ownership and investment interests held by physicians and their immediate family members.
We may also be subject to state and foreign law equivalents of each of the above federal laws; state laws that require manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures; state laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government, or that otherwise restrict payments that may be made to healthcare providers; state and local laws that require the registration of pharmaceutical sales representatives; as well as state and foreign laws that govern the privacy and security of health information in some circumstances, many of which differ from each other in substantial ways and often are not preempted by HIPAA, thus complicating compliance efforts.
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Efforts to ensure that our business arrangements with third parties will comply with applicable healthcare laws and regulations will involve substantial costs. Because of the breadth of these laws and the narrowness of the statutory exceptions and regulatory safe harbors available, it is possible that some of our business activities could be subject to challenge under one or more of such laws. It is possible that governmental authorities will conclude that our business practices may not comply with current or future statutes, regulations or case law involving applicable fraud and abuse or other healthcare laws and regulations. If our operations are found to be in violation of any of these laws or any other governmental regulations that may apply to us, we may be subject to substantial civil, criminal and administrative penalties, damages, fines, disgorgement, imprisonment, exclusion from participating in government funded healthcare programs, such as Medicare and Medicaid, additional reporting requirements and oversight if we become subject to a corporate integrity agreement or similar agreement to resolve allegations of non-compliance with these laws, contractual damages, reputational harm and the curtailment or restructuring of our operations. To the extent that any of our products are sold in a foreign country, we may be subject to similar foreign laws and regulations, which may include, for instance, applicable post-marketing requirements, including safety surveillance, anti-fraud and abuse laws and implementation of corporate compliance programs and reporting of payments or transfers of value to healthcare professionals.
Coverage and Reimbursement
Market acceptance and sales of any drug products depend in part on the extent to which reimbursement for drug products will be available from third party payors, including government health administration authorities, managed care organizations and other private health insurers. third party payors decide which drug products they will pay for and establish reimbursement levels. third party payors often rely upon Medicare coverage policy and payment limitations in setting their own coverage and reimbursement policies. However, decisions regarding the extent of coverage and amount of reimbursement to be provided for drug products are made on a payor-by-payor basis. One payor’s determination to provide coverage for a drug product does not assure that other payors will also provide coverage, and adequate reimbursement, for the drug product. Additionally, a third party payor’s decision to provide coverage for a drug product does not imply that an adequate reimbursement rate will be approved. Each payor determines whether or not it will provide coverage for a drug product, what amount it will pay the manufacturer for the therapy, and on what tier of its formulary it will be placed. The position on a payor’s list of covered drugs, or formulary, generally determines the co-payment that a patient will need to make to obtain the drug product and can strongly influence the adoption of such drug product by patients and physicians. Patients who are prescribed drug products for their conditions and providers prescribing such drug products generally rely on third party payors to reimburse all or part of the associated costs. Patients are unlikely to use a drug product unless coverage is provided and reimbursement is adequate to cover a substantial portion of the cost of the drug product.
Reimbursement by a third-party payor may depend upon a number of factors, including the third-party payor’s determination that a drug product is neither experimental nor investigational, safe, effective, and medically necessary, appropriate for the specific patient, cost-effective, supported by peer-reviewed medical journals and included in clinical practice guidelines.
Third party payors have attempted to control costs by limiting coverage and the amount of reimbursement for particular drug products. Even if reimbursement is available, the level of reimbursement is unpredictable. Inadequate coverage and reimbursement can impact the demand for, or the price of, drug products. If coverage and adequate reimbursement are not available, or are available only to limited levels, drug products may not be successfully commercialized. Further, adequate third-party payor reimbursement may not be available to enable price levels sufficient to realize appropriate returns on investment in drug product development.
In addition, the federal government and state legislatures have continued to implement cost containment programs, including price controls and restrictions on coverage and reimbursement. To contain costs, governmental healthcare programs and third-party payors are increasingly challenging the price, scrutinizing the medical necessity and reviewing the cost-effectiveness of drug products.
Impact of Healthcare Reform on our Business
In the United States and some foreign jurisdictions, there have been, and continue to be, several legislative and regulatory changes and proposed changes regarding the healthcare system that could prevent or delay marketing approval of drug product candidates, restrict or regulate post-approval activities, and affect the profitable sale of drug candidates.
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Among policy makers and payors in the United States and elsewhere, there is substantial interest in promoting changes in healthcare systems with the stated goals of containing healthcare costs, improving quality and / or expanding access. In the United States, the pharmaceutical industry has been a particular focus of these efforts and has been affected by major legislative initiatives. In March 2010, the ACA was passed, which substantially changed the way healthcare is financed by both the government and private insurers, and continues to greatly impact the U.S. pharmaceutical industry. The ACA, among other things: (i) increased the minimum Medicaid rebates owed by manufacturers under the Medicaid Drug Rebate Program and extends the rebate program to individuals enrolled in Medicaid managed care organizations; (ii) established an annual, nondeductible fee on any entity that manufactures or imports certain specified branded prescription drugs and biologic agents apportioned among these entities according to their market share in some government healthcare programs; (iii) expanded the availability of lower pricing under the 340B drug pricing program by adding new entities to the program; (iv) increased the statutory minimum rebates a manufacturer must pay under the Medicaid Drug Rebate Program, to 23.1% and 13% of the average manufacturer price for most branded and generic drugs, respectively and capped the total rebate amount for innovator drugs at 100% of the Average Manufacturer Price, or AMP; (v) expanded the eligibility criteria for Medicaid programs by, among other things, allowing states to offer Medicaid coverage to additional individuals and by adding new mandatory eligibility categories for individuals with income at or below 133% of the federal poverty level, thereby potentially increasing manufacturers’ Medicaid rebate liability; (vi) established a new Medicare Part D coverage gap discount program, in which manufacturers must now agree to offer 70% point-of-sale discounts off negotiated prices of applicable brand drugs to eligible beneficiaries during their coverage gap period, as a condition for the manufacturer’s outpatient drugs to be covered under Medicare Part D; (vii) created a new Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with funding for such research; and (viii) established a Center for Medicare Innovation at CMS to test innovative payment and service delivery models to lower Medicare and Medicaid spending, potentially including prescription drug.
There have been executive, judicial and Congressional challenges to certain aspects of the ACA. For example, on August 16, 2022, the Inflation Reduction Act of 2022, or IRA, was signed into law, which among other things, extends enhanced subsidies for individuals purchasing health insurance coverage in ACA marketplaces through plan year 2025. The IRA also eliminates the “donut hole” under the Medicare Part D program beginning in 2025 by significantly lowering the beneficiary maximum out-of-pocket cost and creating a new manufacturer discount program. It is possible that the ACA will be subject to judicial or Congressional challenges in the future. It is unclear how such challenges, and the healthcare reform measures of the second Trump administration will impact the ACA and our business.
Other legislative changes have been proposed and adopted since the ACA was enacted. These changes include aggregate reductions to Medicare payments to providers of 2% per fiscal year pursuant to the Budget Control Act of 2011, which began in 2013, and due to subsequent legislative amendments to the statute, including the BBA, and the Infrastructure Investment and Jobs Act, will remain in effect through 2032 unless additional Congressional action is taken. Additionally, on March 11, 2021, the American Rescue Plan Act of 2021 was signed into law, which eliminates the statutory Medicaid drug rebate cap, currently set at 100% of a drug’s average manufacturer price, for single source and innovator multiple source drugs, effective on January 1, 2024.
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Additionally, there has been heightened governmental scrutiny in the United States of pharmaceutical pricing practices in light of the rising cost of prescription drugs and biologics. Such scrutiny has resulted in several recent congressional inquiries and proposed and enacted federal and state legislation designed to, among other things, bring more transparency to product pricing, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for products. At the federal level, the IRA, among other things, (i) directs the U.S. Department of Health and Human Services, or HHS, to negotiate the price of certain high-expenditure, single-source drugs that have been on the market for at least 7 years covered under Medicare, and subjects drug manufacturers to civil monetary penalties and a potential excise tax by offering a price that is not equal to or less than the negotiated “maximum fair price” for such drugs and biologics under the law, or the Medicare Drug Price Negotiation Program, and (ii) imposes rebates with respect to certain drugs and biologics covered under Medicare Part B or Medicare Part D to penalize price increases that outpace inflation. The IRA permits HHS to implement many of these provisions through guidance, as opposed to regulation, for the initial years. These provisions take effect progressively starting in fiscal year 2023. On August 15, 2024, HHS announced the agreed-upon prices of the first ten drugs that were subject to price negotiations, although the Medicare Drug Price Negotiation program is currently subject to legal challenges. On January 17, 2025, HHS selected fifteen additional products covered under Part D for price negotiation in 2025. Each year thereafter more Part B and Part D products will become subject to the Medicare Drug Price Negotiation Program. Further, on December 8, 2023, the National Institute of Standards and Technology published for comment a Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights which for the first time includes the price of a product as one factor an agency can use when deciding to exercise march-in rights. While march-in rights have not previously been exercised, it is uncertain if that will continue under the new framework. The current Trump administration is pursuing policies to reduce regulations and expenditures across government including at HHS, the FDA, CMS and related agencies. These actions, presently directed by executive orders or memoranda from the Office of Management and Budget, may propose policy changes that create additional uncertainty for our business. These actions may include, for example, directives to reduce agency workforce, rescinding a Biden administration executive order tasking the Center for Medicare and Medicaid Innovation to consider new payment and healthcare models to limit drug spending and eliminating the Biden administration’s executive order that directed HHS to establishing an AI task force and developing a strategic plan, and directing certain federal agencies to enforce existing law regarding hospital and price plan transparency and by standardizing prices across hospitals and health plans. Additionally, in its June 2024 decision in Loper Bright Enterprises v. Raimondo, the U.S. Supreme Court overturned the longstanding Chevron doctrine, under which courts were required to give deference to regulatory agencies’ reasonable interpretations of ambiguous federal statutes. The Loper Bright decision could result in additional legal challenges to current regulations and guidance issued by federal agencies applicable to our operations, including those issued by the FDA. Congress may introduce and ultimately pass health care related legislation that could impact the drug approval process and make changes to the Medicare Drug Price Negotiation Program created under the IRA.
At the state level, legislatures are increasingly passing legislation and implementing regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing. For example, on January 5, 2024, the FDA approved Florida’s Section 804 Importation Program (SIP) proposal to import certain drugs from Canada for specific state healthcare programs. It is unclear how this program will be implemented, including which drugs will be chosen, and whether it will be subject to legal challenges in the United States or Canada. Other states have also submitted SIP proposals that are pending review by the FDA. Any such approved importation plans, when implemented, may result in lower drug prices for products covered by those programs.
Manufacturing and Supply
We rely on third party manufacturing and supply partners for our supply for, preclinical studies and clinical trials. We currently do not have in-house facilities to manufacture our research and development, preclinical and clinical drug supplies.
Legal Proceedings
From time to time, we may become involved in litigation or other legal proceedings relating to claims arising from the ordinary course of business. There are currently no claims or actions pending against us that, in the opinion of our management, are likely to have a material adverse effect on our results of operations, financial condition or cash flows.
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C. Organizational Structure
The following diagram illustrates our corporate structure at the issuance date of this Annual Report on Form 20-F including the indirect 20% minority equity interest into Neurosterix Pharma Sàrl held by Addex since April 2, 2024 following the sale to Neurosterix Pharma Sàrl of our allosteric modulator drug discovery technology platform and a portfolio of pre-clinical programs:
D. Property, Plants and Equipment.
Our registered office is located in 12, Chemin des Aulx, Plan-les-Ouates, Geneva, Switzerland. Under the service agreement, we are allowed to use at zero cost the administrative offices of Neurosterix Group located in Campus Biotech, Chemin des Mines 9, Geneva, Switzerland.
Item 4A. Unresolved Staff Comments.
Not applicable.
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Item 5. Operating and Financial Review and Prospects.
You should read the following discussion in conjunction with our audited consolidated financial statements, including the related notes thereto, included in this Annual Report on Form 20-F. In addition to historical information, this discussion contains forward-looking statements that involve risks and uncertainties. You should read the sections of this Annual Report on Form 20-F entitled “Item 3D—Risk Factors” and “Special Note Regarding Forward - Looking Statements” for a discussion of the factors that could cause our actual results to differ materially from our expectations.
Overview
We are a clinical-stage pharmaceutical company focused on the development of a portfolio of novel orally available small molecule drug candidates. Our business comprises of a pipeline of proprietary clinical and preclinical stage drug candidates that are being developed by our partners and internally. We or our partners are developing these clinical and preclinical stage proprietary drug candidates for diseases for which there are no approved therapies or where improved therapies are needed including post-stroke sensorimotor recovery, traumatic brain injury, or TBI, recovery, substance use disorder, or, SUD, and chronic cough. We also hold a 20% equity interest in a spin out company, Neurosterix US Holdings LLC, a private company developing a portfolio of preclinical stage proprietary drug candidates for schizophrenia, mood disorders and cognition.
Our lead development compound is dipraglurant, a metabotropic glutamate receptor subtype 5 negative allosteric modulator, or mGlu5 NAM, currently under evaluation for future development in post-stroke/TBI recovery. On April 30, 2025, we announced entering into an option and collaboration agreement with Sinntaxis AB for an exclusive license to intellectual property covering the use of mGlu5 inhibitors for the treatment of brain injury recovery. The agreement also includes a research collaboration under which the Sinntaxis team will complete evaluation of dipraglurant for the treatment of brain injury recovery.
Our second development compound, ADX71149 is a novel orally active metabotropic glutamate receptor subtype 2 positive allosteric modulator, or mGlu2 PAM. On July 22, 2024, we announced that our Partner Janssen terminated the development of drug candidate ADX71149, because the Phase 2 study did not achieve statistical significance for the primary endpoint. On April 17, 2025, we announced that our partner Janssen terminated our partnership agreement and returned to us the program including all related intellectual property to the Group. We are currently evaluating the future development of ADX71149.
Our third development compound is GABAB PAM for chronic cough. In 2024, we completed a funded research program to discover novel gamma-aminobutyric acid subtype-b positive allosteric modulators, or GABAB PAMs, for Indivior PLC, or Indivior. Under the terms of the agreement with Indivior, we had the right to select GABAB PAM drug candidates for a number of reserved indications, including chronic cough. This target is clinically validated with baclofen, an orthosteric agonist of GABAB, used off label to treat chronic cough patients. However, baclofen’s use is limited by serious side-effects, short half-life and gradual loss of efficacy during chronic treatment. By more precisely targeting the GABAB receptor with a PAM we aim to have a best-in-class treatment with improved tolerability suitable for the chronic nature of this disease. This indication has a significant unmet medical need and represents a significant commercial opportunity. On August 27, 2024, Indivior selected a compound for future development in substance use disorder and undertakes all future development of their selected compound. Under the terms of the agreement, we have also exercised our right to select a compound to advance our own independent GABAB PAM program for the treatment of chronic cough. We are currently completing the preclinical evaluation of our selected compound.
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We cannot forecast with any degree of certainty which proprietary products or indications, if any, will be subject to future collaborative arrangements, in whole or in part, and how such arrangements would affect our development plan or capital requirements. To date, we have secured grants and other funding from: The Michael J. Fox Foundation for Parkinson’s Research, or MJFF, for the development of dipraglurant for the treatment of PD-LID; the National Institute of Drug Abuse, or NIDA, to generate important data on the role of GABAB in substance use disorder and the Charcot- Marie - Tooth Association, or CMTA to evaluate the role of GABAB PAM compounds in preclinical models of CMT1A. As we advance our clinical and preclinical programs, we will continue to apply for subsidies, grants and government or agency sponsored studies that could offset or reduce our development costs.
The development and commercialization of drugs is highly competitive. We compete with a variety of multinational pharmaceutical companies and specialized pharmaceutical companies, including products approved for marketing and/or drug candidates under development, for each of the drug candidates and each of the indications for which we are developing. Furthermore, government authorities in the United States, at the federal, state and local levels, and in other countries, extensively regulate, among other things, the research, development, testing, manufacture, packaging, storage, recordkeeping, labeling, advertising, promotion, distribution, marketing, import and export of pharmaceutical products, such as those we are developing. The processes for obtaining regulatory approvals in the United States and in foreign countries, along with subsequent compliance with applicable statutes and regulations, require the expenditure of substantial time and financial resources.
We were founded in May 2002 and completed our initial public offering of shares on the SIX Swiss Exchange in May 2007. On January 29, 2020, we listed American Depositary Shares (ADSs) representing our shares on the Nasdaq Stock Market following the United States Securities and Exchange Commission (SEC) having declared our registration statements on Forms F-1 and F-6 effective. On October 6, 2023, we filed a post-effective amendment to the form F-6 in Addex Therapeutics in order to change our ADS ratio from one ADS to six shares to a new ratio of one ADS to one hundred and twenty shares. The ADS ratio change has been effective since October 23, 2023 and had the same effect as a one to twenty ADS reverse split. The ADS ratio change had no impact on the Company’s underlying shares and was intended to enable the Company to regain compliance with the Nasdaq minimum bid price requirement of ADSs. On November 8, 2023, the company announced that it had received a written notification from Nasdaq confirming that the compliance had been regained.
Our operations to date have included organizing and staffing our company, raising capital, out-licensing rights to our research stage programs including our mGlu2 PAM and GABAB PAM programs and conducting preclinical studies and clinical trials.
To date, we have generated CHF 66.8 million of revenue from the sale of license rights and conducting funded research activities for certain of our research programs. We have historically financed our operations mainly through the sale of equity. Through December 31, 2024, we had raised an aggregate of CHF 355.4 million of gross proceeds from the sale of equity.
We have incurred losses for a total amount of CHF 353 million since our inception. During the twelve-month period ended December 31, 2024 we incurred a net profit of CHF 7.1 million due to reduced operating losses and proceeds from the divestment of part of our business to Neurosterix on April 2, 2024. As part of this transaction we received a gross proceeds of CHF 5.0 million and a 20% equity interest in Neurosterix US Holdings LLC, parent company of Neurosterix Group. During the twelve-month period ended December 31, 2023 and 2022 we incurred net losses of CHF 10.6 million and CHF 20.8 million respectively. We expect to continue to incur significant expenses and operating losses in the medium to long term. We anticipate that our expenses will increase significantly in connection with our ongoing and future activities as we:
| ● | continue to invest in our portfolio of preclinical and clinical stage programs; |
| ● | hire additional research and development, and general and administrative personnel; |
| ● | maintain, expand and protect our intellectual property portfolio; |
| ● | identify and in-license or acquire additional drug candidates; and |
| ● | incur additional costs associated with operating as a public company in the United States. |
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We will need substantial additional funding to support our operating activities as we advance our research and drug candidates through clinical development, seek regulatory approval and prepare for commercialization, if any, of our product candidates are approved. Adequate funding may not be available to us on acceptable terms, or at all.
We have no manufacturing facilities, and all of our manufacturing activities are contracted out to third parties. Additionally, we currently utilize third-party contractors to carry out a significant proportion of our research and development activities. Furthermore, we do not yet have a sales organization.
The Neurosterix Transaction
On April 2, 2024, we divested our allosteric modulator discovery platform and a portfolio of pre-clinical programs to a new Swiss company, Neurosterix Pharma Sàrl (equivalent to an LLC), focused on the discovery and development of novel orally available allosteric modulator drug candidates, including M4 PAM for schizophrenia, mGlu7NAM for stress related disorders and mGlu2NAM for mild neurocognitive disorders. In connection with the Transaction, we received gross proceeds of CHF 5.0 million and a 20% equity interest in Neurosterix US Holdings LLC, the parent company of Neurosterix Pharma Sàrl. Neurosterix US Holdings LLC received USD 63.0 million in funding commitments from a syndicate of investors led by Perceptive Advisors.
The divestment of our discovery platform and early-stage programs includes the transfer of the associated research and development staff, with a service agreement to allow key members of staff to support us in achieving our business strategy at zero cost for us. As of the date of the Transaction, all employees of the Group, other than our Head of Finance, became employees of Neurosterix Pharma Sàrl. Pursuant to the service agreement, certain former employees, including our Chief Executive Officer, dedicate a portion of their time to the Group.
License Agreement with Indivior
In January 2018, we entered into an agreement with Indivior for the discovery, development and commercialization of novel GABAB PAM compounds for the treatment of addiction and other CNS diseases. This agreement included the selected clinical candidate, ADX71441. In addition, Indivior agreed to fund a research program at Addex to discover novel GABAB PAM compounds.
Indivior has sole responsibility, including funding liability, for development of selected compounds under the agreement through preclinical and clinical trials, as well as registration procedures and commercialization, if any, worldwide. Indivior has the right to design development programs for selected compounds under the agreement. Through our participation in a joint development committee, we review, in an advisory capacity, any development programs designed by Indivior. However, Indivior has authority over all aspects of the development of such selected compounds.
Under terms of the agreement, we have granted Indivior an exclusive license to use relevant patents and know-how in relation to the development and commercialization of drug candidates selected by Indivior. Subject to agreed conditions, Addex and Indivior jointly own all intellectual property rights that are jointly developed, and Addex or Indivior individually own all intellectual property rights that Addex or Indivior develop individually. Addex has retained the right to select compounds from the research program for further development in areas outside the interest of Indivior including chronic cough. Under certain conditions, but subject to certain consequences, Indivior may terminate the agreement.
In January 2018, under terms of the agreement, we received a non-refundable upfront fee of USD 5.0 million for the right to use the clinical candidate, ADX71441, including all materials and know-how related to this clinical candidate. On February 14, 2019, Indivior terminated the development of their selected compound, ADX71441.
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Separately, Indivior funded research at Addex, based on a research plan to mutually agreed between the parties, to discover novel GABAB PAM compounds. These future novel GABAB PAM compounds, if selected by Indivior, become licensed compounds. We agreed with Indivior to an initial research term and duration of two years with a funding of USD 4.0 million over the period for our R&D costs incurred, that can be extended by twelve-month increments. Following Indivior’s selection of one newly identified compound, Addex has the right to also select one additional newly identified compound. Addex was responsible for the funding of all development and commercialization costs of its selected compounds and Indivior has no rights to the Addex selected compounds. The initial two-year research term ran from May 2018 to April 2020. In 2019, Indivior agreed to additional research funding of USD 1.6 million and on October 30, 2020, the research term was extended until June 30, 2021 and Indivior agreed to further additional research funding of USD 2.8 million. Effective May 1, 2021, the research term was extended until July 31, 2022 and Indivior agreed additional research funding of CHF 3.7 million, of which CHF 2.7 million has been paid to us, and CHF 1.0 million paid directly by Indivior to third party suppliers that supported the funded research program. In August 2022, the research agreement was extended until March 31, 2023 with additional research funding of CHF 0.85 million. The reserved indications, where Addex retains exclusive rights to develop its own independent GABAB PAM program, were also expanded to include chronic cough. Effective November 1, 2022 the research term was extended until June 30, 2023 and Indivior agreed to additional research funding of CHF 0.95 million. Effective July 1, 2023, the research term was extended until June 30, 2024 and Indivior agreed to additional research funding of CHF 2.7 million including CHF 1.1 million received directly by us and CHF 1.6 million paid directly by Indivior to third party suppliers that are supporting the funded research program.
On August 27, 2024, Indivior selected a compound for future development in substance use disorders and now undertake all future development of their selected compound. Under the terms of the agreement, we have also exercised our right to select a compound to advance our own independent GABAB PAM program for the treatment of chronic cough. Under the license agreement, we are as well eligible for payments on successful achievement of pre-specified clinical, regulatory and commercial milestones totaling USD 330 million. In addition, we are eligible for tiered royalties from high single digits to low double digits on net sales of applicable products on a country-by country-basis. The term of the royalty for each licensed product in any particular country commences on such product’s launch and ends on the latest of ten -year anniversary of launch, expiration of certain applicable patent rights, and expiration of certain applicable marketing or data exclusivity periods.
The contract contains two distinct material promises and performance obligations: (1) the selected compound ADX71441 which falls within the definition of a licensed compound, whose rights of use and benefits thereon was transferred in January 2018 and, (2) the research services to be conducted by Addex and funded by Indivior to discover novel GABAB PAM compounds for clinical development that may be discovered over the research term of the agreement and selected by Indivior.
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Components of Results of Operations
Revenue
From the beginning of January 2017 through December 2024, we recognized CHF 18.8 million as revenue primarily under our license agreement with Indivior. We do not have approval to market or commercialize any of our drug candidates, we have never generated revenue from the sale of products and we do not expect to generate any revenue from product sales for the foreseeable future. Prior to approval of a drug candidate, we will seek to generate revenue from a combination of license fees, milestone payments in connection with collaborative or strategic relationships, royalties resulting from the licensing of our drug candidates and payments from sponsored research and development activities as well as grants from governmental and non-governmental organizations.
Revenue from collaborative arrangements comprises the fair value for the sale of products and services, net of value-added tax, rebates and discounts. Revenue from the rendering of services is recognized in the accounting period in which the services are rendered, by reference to completion of the specific transaction assessed on the basis of the actual service provided as a proportion of the total service to be provided. Revenue from collaborative arrangements may include the receipt of non-refundable license fees, milestone payments, and research and development payments. When we have continuing performance obligations under the terms of the arrangements, non-refundable fees and payments are recognized as revenue by reference to the completion of the performance obligation and the economic substance of the agreement.
Our revenue has varied, and we expect revenue to continue to vary, substantially from year to year, depending on the structure and timing of milestone events, as well as our development and commercialization strategies and those of our collaboration partners for our drug candidates. We, therefore, believe that historical period to period comparisons are not meaningful and should not be relied upon as an indicator of our future revenue and performance potential.
Other Income
From the beginning of January 2017 through December 2024, we recognized CHF 1.7 million as other income including CHF 1.2 million relating to grants from The Michael J. Fox Foundation for Parkinson’s Research, or MJFF, to finance certain clinical activities related to dipraglurant development in Parkinson’s disease levodopa-induced dyskinesia, or PD-LID, and other discovery activities.
In July 2019, we received a grant from Eurostars/Innosuisse for CHF 0.5 million to support our mGlu7 NAM program totally recognized as income as of December 31, 2021. The mGlu7 NAM program has been transferred to Neurosterix Pharma Sàrl on April 2, 2024.
In September 2023, we received a grant from Eurostars/Innosuisse for CHF 0.5 million to support the mGlu2 NAM program of which CHF 0.3 million were received in December 2023. We recognized CHF 38,401 from January 1, 2024 to April 2, 2024, the date when the program was transferred to Neurosterix Pharma Sàrl and recorded as discontinued operations. The remaining funds and deferred income of CHF 0.3 million recorded as assets and liabilities held for sale as of April 2, 2024 have been transferred to Neurosterix Pharma Sàrl.
Grants are recognized at their fair value where there is reasonable assurance that the grant will be received and that we will comply with all associated conditions. Grants relating to costs are recognized as other income in the statement of comprehensive loss over the period necessary to match them with the costs that they are intended to compensate.
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Operating Expenses
Research and Development Costs
From the beginning of January 2017 through December 2024, we incurred CHF 67.0 million in research and development costs. They consist mainly of direct research costs, which include costs associated with the use of contract research organizations, or CROs, and consultants hired to assist on our research and development activities, personnel costs, share-based compensation for our employees and consultants, costs related to regulatory affairs and intellectual property, as well as depreciation for assets used in research and development activities. Following the Neurosterix Transaction executed on April 2, 2024, research and development costs no longer include personnel costs and share-based compensation for employees. For the twelve-month periods ended December 31, 2022, 2023 and 2024 respectively, the research and development costs related to divested activities have been recognized in our statements of profit or loss under “Net profit or loss from discontinued operations”.
We currently use our consultants and CRO’s across our research and development programs. The following table provides a breakdown of our outsourced research and development costs from continuing operations that are directly attributable to the specified programs for the years ended December 31, 2024, 2023 and 2022:
| For the years ended December 31, | |||||
| 2024 |
| 2023* |
| 2022* | |
| (CHF in thousands, unaudited) | |||||
Dipraglurant |
| 78 |
| (99) |
| 6,616 |
GABAB PAM |
| 357 |
| 1,042 |
| 1,268 |
Total outsourced research and development costs |
| 435 |
| 943 |
| 7,884 |
*The 2023 and 2022 comparatives have been re-presented in order to disclose only continuing operations following the Neurosterix Transaction described above. For more information, please refer to the paragraph below related to the analysis of results of operations.
Our research and development expenses are lower due to the Neurosterix Transaction. The table above relates to outsourced research and development costs from continuing operations. Outsourced research and development costs related to discontinued operation have been recognized in the statements of profit or loss under “net profit or loss from discontinued operations”.
We have no ongoing self-funded clinical studies and in the medium and long term, our expenses may increase, particularly as we continue to the development of a GABAB PAM drug candidate, initiate further clinical trials and seek marketing approval for our drug candidates.
At this time, we cannot reasonably estimate or know the nature, timing and estimated costs of the efforts that will be necessary to complete the development of our drug candidates. We are also unable to predict when, if ever, material net cash inflows will commence from sales of our drug candidates. This is due to the numerous risks and uncertainties associated with developing such drug candidates, including:
| ● | uncertainty related to discovering clinical candidates; |
| ● | uncertainty related to efficiently manufacturing and distributing drug products; |
| ● | competitor intellectual property restraining our freedom to operate; and |
| ● | timing of initiation, completion and outcome of further clinical trials; |
In addition, the probability of success for any of our drug candidates will depend on numerous factors, including competition, manufacturing capabilities and commercial viability. A change in the outcome of any of these variables with respect to the development of any of our drug candidates would significantly change the costs, timing and viability associated with the development of that drug candidate.
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General and Administrative Costs
General and administrative costs consist primarily of personnel costs, including salaries, benefits and share-based compensation cost for our employees as well as corporate facility costs not otherwise included in research and development expenses, legal fees related to corporate matters and fees for accounting and financial or tax consulting services.
Our general and administrative costs are lower due to the Neurosterix Transaction. General and administrative costs indicated in this section are related to continuing operations. General and administrative costs related to discontinued operations have been recognized in the statements of profit or loss under “net profit or loss from discontinued operations”.
Finance Result, Net
Finance result net consists mainly of currency exchange differences, primarily related to U.S dollar currency exchange differences and interest income on U.S dollar bank deposits.
Net profit or loss from discontinued operations
The net profit or loss from discontinued operations has been recognized in the statements of profit or loss under “net profit or loss from discontinued operations”. It primarily relates to the net gain of CHF 14.0 from the divestment of a part of our business to Neurosterix Pharma Sàrl on April, 2, 2024, partially offset by the net loss from discontinued operating activities mainly related to staff costs, research and development costs, general and administrative costs and finance result of divested activities.
Share of net loss of investments accounted for using the equity method
We received an equity interest of 20% in Neurosterix US Holdings LLC as part of the Neurosterix Transaction. The equity interest has been recognized as an investment at fair value based on a financial valuation of Neurosterix’s Group. The carrying amount of the investment is going to be increased or decreased to recognize the share of profit or loss of Neurosterix’s Group and tested for impairment whenever events or changes in circumstances indicate that it may not be recoverable.
Taxation
We are subject to corporate taxation in Switzerland, United States and France. We are also entitled under Swiss laws to carry forward any losses incurred for a period of seven years and can offset our losses carried forward against future taxes. As of December 31, 2024, we had tax losses carried forward totaling CHF 175.5 million of which CHF 3.6 million will expire by the end of 2025. Deferred income taxes are not recognized as we do not believe it is probable that we will generate sufficient taxable profits to utilize these tax losses carried forward.
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A. Operating Results
Analysis of Results of Operations
The following table presents our consolidated results of operations for the fiscal years 2024, 2023 and 2022.
| For the years ended December 31, | |||||
| 2024 |
| 2023* |
| 2022* | |
| (CHF in thousands, unaudited) | |||||
Revenue |
| 404 |
| 1,613 |
| 1,422 |
Other Income |
| 6 |
| 4 |
| 23 |
Research and development costs |
| (854) |
| (1,187) |
| (8,244) |
General and administrative costs |
| (2,311) |
| (2,673) |
| (3,742) |
Operating loss from continuing operations |
| (2,755) |
| (2,243) |
| (10,541) |
Finance income |
| 27 |
| 64 |
| 29 |
Finance expense | (4) | (321) | (292) | |||
Finance result | 23 | (257) | (263) | |||
Share of net loss of investments accounted for using the equity method | (2,177) | — | — | |||
Net loss before tax from continuing operations | (4,909) | (2,500) | (10,804) | |||
Income tax expense | — | — | — | |||
Net loss from continuing operations | (4,909) | (2,500) | (10,804) | |||
Net profit / (loss) from discontinued operations (attributable to equity holders of the Group) |
| 11,965 |
| (8,056) |
| (10,000) |
Net profit / (loss) for the period |
| 7,056 |
| (10,556) |
| (20,804) |
*The comparative information has been re-presented due to discontinued operations that have been reclassed to the financial line called “Net profit or loss from discontinued operations”, following the Neurosterix Transaction described above. In the financial analysis related to the results of operations made further in the section an asterisk will indicate where comparative information has been represented.
Year Ended December 31, 2024 Compared to Year Ended December 31, 2023
Revenue
The following table sets forth our revenue in 2024 and 2023.
| For the years | |||
ended | ||||
December 31, | ||||
2024 |
| 2023* | ||
(CHF in thousands) | ||||
Collaborative research funding | 404 | 1,613 | ||
Total |
| 404 |
| 1,613 |
Revenue decreased by CHF 1.2 million in 2024 compared to 2023 primarily due to the termination of the research agreement with Indivior on June 30, 2024.
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Other Income
The following table sets forth our other income in 2024 and 2023.
| For the years | |||
ended | ||||
December 31, | ||||
2024 |
| 2023* | ||
(CHF in thousands) | ||||
Other service income | 6 | 4 | ||
Total |
| 6 |
| 4 |
Other income recognized primarily related to IT consulting services and was close to nil in 2024 and 2023.
Research and Development Expenses
The following table sets forth our research and development expenses in 2024 and 2023.
For the years | ||||
ended | ||||
December 31, | ||||
| 2024 |
| 2023* | |
(CHF in thousands, unaudited) | ||||
Dipraglurant PD‑LID |
| 78 |
| (99) |
GABAB PAM |
| 357 |
| 1,042 |
Subtotal outsourced R&D per program |
| 435 |
| 943 |
Depreciation |
| 78 |
| — |
Patent maintenance and registration costs |
| 283 |
| 229 |
Other operating expenses |
| 58 |
| 15 |
Subtotal unallocated R&D expenses |
| 419 |
| 244 |
Total |
| 854 |
| 1,187 |
Research and development expenses, relating to continuing activities, decreased by CHF 0.3 million in 2024 compared to 2023, primarily due to lower GABAB PAM outsourced R&D expenses as we completed our research agreement with Indivior on June 30, 2024.
General and Administrative Costs
The following table sets forth our general and administrative costs in 2024 and 2023.
For the years | ||||
ended | ||||
December 31, | ||||
2024 |
| 2023* | ||
(CHF in thousands, unaudited) | ||||
Staff costs |
| 243 |
| 237 |
Depreciation |
| 115 |
| 12 |
Professional fees |
| 1,207 |
| 1,164 |
D&O insurance |
| 226 |
| 629 |
Other operating costs |
| 520 |
| 631 |
Total |
| 2,311 |
| 2,673 |
General and administrative costs, relating to continuing activities, decreased by CHF 0.4 million in 2024 compared to 2023, primarily due to reduced D&O insurance costs.
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Finance Result, Net
The following table sets forth our finance result net in 2024 and 2023.
| For the years | |||
ended | ||||
December 31, | ||||
2024 |
| 2023* | ||
(CHF in thousands) | ||||
Interest income |
| 9 |
| 64 |
Interest expense |
| (1) |
| (2) |
Interest cost on leases | (2) | (2) | ||
Foreign exchange gain / (loss), net |
| 17 |
| (317) |
Total |
| 23 |
| (257) |
Finance result, net increased by CHF 0.3 million in 2024 compared to 2023, primarily due to reduced exchange differences as our cash deposits in U.S dollar have decreased.
Share of net loss of investments accounted for using the equity method
The following table sets forth our share of net loss of Neurosterix’s Group in 2024 and 2023.
For the years | ||||
ended | ||||
December 31, | ||||
| 2024 |
| 2023* | |
(CHF in thousands) | ||||
Share of net loss for the period of Neurosterix’s Group | (2,177) | — | ||
Total | (2,177) | — | ||
The share of the net loss of Neurosterix’s Group amounted to CHF 2.2 million in 2024 and relates to 20% of the net loss incurred by Neurosterix group from its inception on April 2, 2024 to December 31, 2024.
Year Ended December 31, 2023 Compared to Year Ended December 31, 2022
Revenue
The following table sets forth our revenue in 2023 and 2022.
For the years | ||||
ended | ||||
December 31, | ||||
| 2023* |
| 2022* | |
| (CHF in thousands) | |||
Collaborative research funding |
| 1,613 |
| 1,422 |
Total |
| 1,613 |
| 1,422 |
Revenue increased by CHF 0.2 million in 2023 compared to 2022 due to amounts received under our agreement with Indivior which are recognized as related costs are incurred.
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Other Income
The following table sets forth the other income in 2023 and 2022.
For the years | ||||
ended | ||||
December 31, | ||||
| 2023* |
| 2022* | |
| (CHF in thousands) | |||
Other service income |
| 4 |
| 23 |
Total |
| 4 |
| 23 |
Other income recognized primarily related to IT consulting services and was close to nil in 2023 and 2022.
Research and Development Expenses
The following table sets forth our research and development expenses in 2023 and 2022.
For the years | ||||
ended | ||||
December 31, | ||||
| 2023* |
| 2022* | |
| (CHF in thousands, | |||
| unaudited) | |||
Dipraglurant |
| (99) |
| 6,616 |
GABAB PAM |
| 1,042 |
| 1,268 |
Subtotal outsourced R&D per program |
| 943 |
| 7,884 |
Patent maintenance and registration costs |
| 229 |
| 266 |
Short-term leases |
| — |
| 15 |
Other operating expenses |
| 15 |
| 79 |
Subtotal unallocated R&D expenses |
| 244 |
| 360 |
Total |
| 1,187 |
| 8,244 |
Research and development expenses, relating to continuing activities, decreased by CHF 7.1 million in 2023 compared to 2022, mainly due to decreased outsourced R&D costs for CHF 6.9 million attributed to reduced dipraglurant clinical development activities terminated on June 17, 2022. Changes in estimates of costs to terminate the dipraglurant clinical development resulted in the release of CHF 0.2 million of previously recorded accruals resulting in a credit to dipraglurant related R&D costs in 2023.
General and Administrative Costs
The following table sets forth our general and administrative costs in 2023 and 2022.
| For the years | |||
ended | ||||
December 31, | ||||
| 2023* |
| 2022* | |
| (CHF in thousands, | |||
| unaudited) | |||
Staff costs |
| 237 |
| 253 |
Depreciation |
| 12 |
| 9 |
Professional fees |
| 1,164 |
| 1,418 |
D&O Insurance |
| 629 |
| 1,591 |
Other operating costs |
| 631 |
| 471 |
Total |
| 2,673 |
| 3,742 |
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General and administrative costs, relating to continuing activities, decreased by CHF 1.1 million in 2023 compared to 2022, primarily due to reduced D&O insurance costs.
Finance Result, Net
The following table sets forth our finance result net in 2023 and 2022.
For the years | ||||
ended | ||||
December 31, | ||||
| 2023* |
| 2022* | |
| (CHF in thousands) | |||
Interest income |
| 64 |
| 29 |
Interest expense |
| (2) |
| (26) |
Interest cost on leases | (2) | (2) | ||
Foreign exchange loss, net |
| (317) |
| (264) |
Total |
| (257) |
| (263) |
Finance result, net remained stable in 2023 compared to 2022 and primarily relates to foreign exchange loss on USD cash deposits partially offset by interest income related to USD cash deposits.
| B. | Liquidity and Capital Resources |
Since our inception through December 31, 2024, we have generated CHF 66.8 million of revenue and have incurred net losses and negative cash flows from our operations. We have funded our operations primarily through the sale of equity. From inception through December 31, 2024, we raised an aggregate of CHF 355.4 million of gross proceeds from the sale of equity. We have also raised gross proceeds of CHF 5.0 million and acquired a 20% equity interest in Neurosterix US Holdings LLC as part of the Neurosterix Transaction executed on April 2, 2024. As at December 31, 2024, we had CHF 3.3 million in cash and cash equivalents.
Our primary uses of cash are to fund operating expenses, which consist mainly of research and development expenditures and associated general and administrative costs. Cash used to fund operating expenses is impacted by the timing of when we pay these expenses, as reflected in the changes in our outstanding accounts payable and accrued expenses. We currently have no ongoing material financing commitments, such as lines of credit or guarantees.
In the medium and long term, we expect an increase of our expenses compared to the twelve-month period ended December 31, 2024, as we continue to the development of our GABAB PAM chronic cough drug candidate, initiate further clinical trials and seek marketing approval for our drug candidates.
In addition, if we obtain marketing approval for any of our drug candidates, we expect to incur significant commercialization expenses related to program sales, marketing, manufacturing and distribution to the extent that such sales, marketing and distribution are not the responsibility of potential collaborators. Accordingly, we will need to obtain substantial additional funding in connection with our continuing operations. If we are unable to raise capital when needed or on attractive terms, we would be forced to delay, reduce or eliminate our research and development programs or future commercialization efforts.
We expect our existing cash and cash equivalents at the issuance date of Annual Report on Form 20-F will enable us to fund our operating expenses and capital expenditure requirements through mid - June 2026. Our future viability is dependent on our ability to monetize our intellectual property portfolio and /or raise additional capital though public or private financings that may dilute existing shareholders. We have based this estimate on assumptions that may prove to be wrong, and we could utilize our available capital resources sooner than we currently expect. Our future capital requirements will depend on many factors, including:
| ● | the scope, progress, results and costs of our ongoing and planned preclinical study for our GABAB PAM chronic cough drug candidate; |
| ● | the timing and amount of milestone and royalty payments we may receive under our license agreements; |
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| ● | the extent to which we out-license, in-license, sell or acquire other drug candidates and technologies; |
| ● | the number and development requirements of other drug candidates that we may pursue; |
| ● | the costs, timing and outcome of regulatory review of our drug candidates; |
| ● | cost associated with finding alternative suppliers due to geopolitical events such as the ongoing war in Ukraine; |
| ● | the costs associated with building out our operations; and |
| ● | the costs and timing of future commercialization activities, including drug manufacturing, marketing, sales and distribution, for any of our drug candidates for which we receive marketing approval. |
Identifying potential drug candidates and conducting preclinical studies and clinical trials is a time-consuming, expensive and uncertain process that takes many years to complete, and we may never generate the necessary data or results required to obtain marketing approval and achieve product sales. In addition, our drug candidates, if approved, may not achieve commercial success. Our revenue, if any, will be derived from sales of products that we do not expect to be commercially available for many years, if at all.
Until such time, if ever, as we can generate substantial product revenue, we may finance our cash needs through a combination of equity offerings, debt financings, collaborations, strategic alliances and licensing arrangements. To the extent that we raise additional capital through the sale of equity or convertible debt securities, your ownership interest will be diluted, and the terms of any additional securities may include liquidation or other preferences that adversely affect your rights as a shareholder. Debt financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends.
If we raise funds through additional collaborations, strategic alliances or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or drug candidates or to grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financings when needed, we may be required to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market drug candidates that we would otherwise prefer to develop and market ourselves.
The following table shows a summary of our cash flows of the continuing operations for the years indicated:
For the years ended December 31, | ||||||
| 2024 |
| 2023 |
| 2022 | |
| (CHF in thousands) | |||||
Net cash flows used in continuing operating activities |
| (2,772) |
| (2,168) |
| (9,755) |
Net cash flows (used in) / from continuing investing activities |
| (1) |
| — |
| 4 |
Net cash flows from continuing financing activities |
| 174 |
| 5,553 |
| 3,400 |
Net cash (used in) / from continuing activities |
| (2,599) |
| 3,385 |
| (6,351) |
Operating Activities of Continuing Operations
Net cash flows from or used in operating activities consist of the net loss from continuing operations adjusted for changes in net working capital (current assets less current liabilities), and for non-cash items such as depreciation, the value of share-based services and changes in post-employment benefits.
During the year ended December 31, 2024, continuing operating activities used CHF 2.8 million of cash primarily due to our net loss from continuing operations of CHF 4.9 million partially offset by non-cash items amounting to CHF 2.5 million primarily related to the share of the net loss of the Neurosterix’s Group.
During the year ended December 31, 2023, continuing operating activities used CHF 2.2 million of cash primarily due to our net loss from continuing operations of CHF 2.5 million partially offset by non-cash items of CHF 0.3 million primarily related to share-based costs.
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During the year ended December 31, 2022, continuing operating activities used CHF 9.8 million of cash primarily due to our net loss from continuing operations of CHF 10.8 million adjusted for CHF 0.2 million of net finance costs, partially offset by non-cash items for CHF 0.7 million primarily related to share-based compensation costs.
Investing Activities of Continuing Operations
During the year ended December 31, 2024, 2023 and 2022 investing activities were close to nil and primarily related to investments in software and computer hardware.
Financing Activities of Continuing Operations
Net cash flows from financing activities related to continuing operations, primarily consists of proceeds from the sale of equity securities.
During the year ended December 31, 2024, net cash flows from financing activities amounted to CHF 0.2 million and primarily related to the sale of treasury shares through the sale agency agreement managed by Kepler Cheuvreux.
During the year ended December 31, 2023, net cash flows from financing activities amounted to CHF 5.6 million including CHF 4.5 million from the offering executed with an institutional investor on April 3, 2023 and CHF 1.2 million from the sale agency agreement managed by Kepler Cheuvreux, partially offset by costs associated with the offering, the sale and the issuance of treasury shares whose combined amount paid during the annual year ended December 31, 2023 amounted to CHF 0.3 million.
During the year ended December 31, 2022, net cash flows from financing activities amounted to CHF 3.4 million and relate to an offering executed on July 22, 2022 with an institutional investor and sales of treasury shares through the sale agency agreement with Kepler Cheuvreux in July 2022 with gross proceed of CHF 4.1 million and CHF 0.4 million, respectively, partially offset by the costs associated with the offering executed on December 16, 2021 and July 22, 2022 and paid in 2022 for CHF 0.5 million and CHF 0.4 million, respectively. The other cash out flows primarily relate to the issuance cost of new treasury shares executed in 2022 for a total amount of CHF 0.2 million.
Lease Liabilities and Commitments
The maturities for lease payments in relation to operating lease under IFRS 16 as of December 31, 2024 are as follows:
Carrying | ||||||||||
| Less than |
| 1 to |
| More than |
| Total cash |
| amount | |
At December 31 2024 | 1 Year | 5 Years | 5 Years | out flows | liabilities | |||||
(CHF in thousands) | ||||||||||
Lease Liabilities |
| 9 |
| 39 |
| — |
| 48 |
| 42 |
Lease liabilities relate to the rent related to our registered office located at 12, Chemin des Aulx, Plan-Les-Ouates, Geneva. Under the service agreement, we are allowed to use at zero cost the administrative offices of Neurosterix Group located in Campus Biotech, Chemin des Mines 9, Geneva, Switzerland.
We have no cancellable operating lease commitments over 5 years. We enter into contracts in the normal course of business with CROs for preclinical studies, manufacturing and other services and products for operating purposes. These contracts generally provide for termination upon notice, and therefore we believe that our non-cancelable obligations under these agreements are not material.
Outstanding Debt
We do not engage in trading activities involving non-exchange traded contracts nor do we currently have any debt outstanding. We therefore believe that we are not materially exposed to any financing, liquidity, market or credit risk that could arise if we had engaged in these relationships.
68
| C. | Research and Development |
For a discussion of our research and development activities, see “Item 4.B—Business Overview” and “Item 5.A—Operating Results.”
| D. | Trend Information |
For a discussion of trends, see “Item 5.A—Operating Results” and “Item 5.B—Liquidity and Capital Resources.”
| E. | Critical Accounting Estimates |
Not applicable
Item 6. Directors, Senior Management and Employees.
A. | Directors and Senior Management. |
The following table sets forth information regarding our executive officers and directors, including their ages, as of December 31, 2024. Our directors are appointed for one-year terms, which expire on the occasion of each annual general meeting.
Name |
| Age |
| Position(s) |
Executive Officers: |
|
| ||
Tim Dyer |
| 56 |
| Chief Executive Officer and Director |
Roger Mills |
| 68 |
| Chief Medical Officer and Director |
Mikhail Kalinichev |
| 57 |
| Head of Translational Science |
Lénaïc Teyssédou(1) |
| 39 |
| Head of Finance |
Non-Employee Directors: |
|
| ||
Vincent Lawton(2)(3) |
| 75 |
| Chairman of the Board of Directors |
Raymond Hill(2) |
| 79 |
| Director |
Isaac Manke(3) |
| 47 |
| Director |
Jake Nunn(3) |
| 54 |
| Director |
| (1) | Mr. Teyssédou became a member of the Executive Management on April 2, 2024 |
| (2) | Member of the Compensation Committee |
| (3) | Member of the Audit Committee |
Executive Officers
Tim Dyer, Co-Founder, Director and Chief Executive Officer: Since co-founding Addex in 2002, Mr. Dyer has played a pivotal role in building the Addex Group, raising significant capital, including Addex IPO, Nadaq listing, Neurosterix spin-out and negotiating licensing agreements with pharmaceutical industry partners. Prior to founding Addex, he spent 10 years with Price Waterhouse, or PW & PricewaterhouseCoopers, or PwC in the UK and Switzerland as part of the audit and business advisory group. Mr Dyer serves on the board of directors of Neurosterix and served as Neurosterix CEO/CFO from April 2024 to April 2025. Mr. Dyer has extensive experience in business development, finance, corporate operations and the building of start-up companies. He is a UK Chartered Accountant and holds a BSc (Hons) in Biochemistry and Pharmacology from the University of Southampton, UK.
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Roger Mills, Director and Chief Medical Officer: Dr. Mills brings more than 30 years of biopharmaceutical industry experience at both large global pharmaceutical companies and smaller biotechnology companies, including Acadia Pharmaceuticals, Pfizer, Gilead Sciences, Abbott Laboratories and The Wellcome Foundation, across a spectrum of disease areas. His extensive track record includes managing drug development programs, including IND’s and NDAs as well as post-marketing and OTC products. Most recently, Dr. Mills was with Acadia Pharmaceuticals for nine years, serving as Executive Vice President, Development and Chief Medical Officer. In this role, he oversaw the largest ever international Phase 3 program in Parkinson’s Disease Psychosis and led its NDA submission to the FDA for NUPLAZID, which was subsequently approved and remains the first and only medication approved in this indication. Dr. Mills currently serves as an Honorary Professor at the University of Exeter, UK and is a Fellow of the Faculty of Pharmaceutical Medicine, a faculty of the three Royal Colleges of Physicians of the UK. He is a member of the Board of Directors of Enterin Inc, a US biopharmaceutical company. He received his medical degree from Imperial College, Charing Cross Hospital Medical School, London, United Kingdom.
Mikhail Kalinichev, Head of Translational Science: Mr Kalinichev is the head of translational science for the Neurosterix Group and currently serves as the head of translational science under the service agreement between Addex and Neurosterix. In August 2021, Dr. Kalinichev jointed for the second time the Addex team in the role of the Head of Translational Science. Dr. Kalinichev previously spent 4 years in the company in several positions, including Associate Director and Group Leader, Behavioral Neuroscience. Immediately before his second appointment at Addex, Dr. Kalinichev spent 6 years as Director of in vivo neurology at Ipsen, France. In this role, he helped define the neuroscience therapeutic strategy, led operational activities and initiated several industrial and academic collaborations in the area of neuromuscular disorders and pain. Before Ipsen, he was a section head at Lundbeck, Denmark where he helped drive translational studies in schizophrenia, cognitive impairment and pain. His first role in pharmaceutical industry was as a principal scientist at Psychiatry Center of Excellence of GlaxoSmithKline, UK. Dr. Kalinichev’s post-doctoral training was at the Department of Pharmacology, Emory University School of Medicine (USA). Dr. Kalinichev has been awarded several prestigious awards, including the Vernalis Prize of the British Association for Psychopharmacology and the GlaxoSmithKline Exceptional Science Award. He is inventor on several patents and co-authored more than 50 papers. Dr. Kalinichev earned his PhD in behavioural neuroscience at Rutgers University (USA).
Lénaic Teyssédou, Head of Finance: Mr. Teyssédou has worked as Head of finance of Addex since June 2017 and has extensive experience in the financial management of both private and public companies. Mr. Teyssédou is a French certified public accountant and worked in audit firms where he gained valuable experience related to audit, due diligence, financial regulation and compliance across a diverse client portfolio of startups, small and mediume size companies. Mr Teyssédou also holds two master’s degrees in Finance and Management from EM Strasbourg Business School, France.
Non-Employee Directors
Vincent Lawton, Chairman of the Board of Directors: Professor Lawton was Vice President Merck Europe and Managing Director of MSD UK until he stepped down in 2006, after 26 years’ service internationally for Merck & Co Inc. He was appointed CBE (Commander of the British Empire) by the Queen of England for services to the Pharmaceutical Industry. During his tenure, MSD UK achieved sustained commercial success, launching many new medicines to the market in a wide range of therapeutic areas, becoming the fastest growing company in the market over a number of years. He worked in commercial, research and senior management roles in France, the US and Canada, Spain and throughout Europe. As President of the UK Industry Association, the ABPI, he negotiated industry pricing, worked with Government bodies to help establish the UK globally as a leading center of clinical research. He served on the board of the UK regulatory authority (MHRA) from 2008 to 2015. He was Senior Strategy Adviser for Imperial College Department of Medicine, University of London and serves as a consultant to a number of leading healthcare organizations. He is also a board member of Neurosterix. He studied Psychology at the University of London and holds an undergraduate degree and PhD.
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Raymond Hill, Director: Dr. Hill was previously a member of the Board of Directors from the Annual General Meetings of 2008 until 2012. Currently Visiting Professor of Pharmacology at Imperial College in London, Chairman/Non-Executive Director of Avilex (Denmark) and member of the SAB of Neurosterix (Switzerland), an allosteric modulator drug discovery and development company based on the former Addex Technology platform of which Addex owns a 20% equity interest. Dr Hill was previously Chair of SAB Asceneuron (Switzerland) from 2014 to 2021 and was NED of Orexo AB (Sweden) from 2008 to 2019. Prior to his retirement, he was Executive Director, Licensing and External Research at Merck/MSD in Europe (2002-2008); Executive Director, Pharmacology (1990-2002) at the Merck Neuroscience Research Centre and had oversight responsibility for Neuroscience research at the Banyu Research Labs in Tsukuba, Japan (1997-2002). At Merck, he chaired a number of discovery project teams including those responsible for the marketed products Maxalt® and Emend®. Dr. Hill received his academic training (BPharm PhD) at the University of London. He was awarded an Honorary DSc by the University of Bradford in 2004 and was elected to Fellowship of the Academy of Medical Sciences in 2005. He was a lecturer in Pharmacology at the University of Bristol School of Medicine from 1974 to 1983 and supervisor in Pharmacology at Downing College, University of Cambridge from 1983 to 1988. He joined the pharmaceutical industry in 1983 as Head of Biology and founder member of the Park Davis Research Unit at Cambridge. In 1988, he joined SK&F (United Kingdom) as Group Director of Pharmacology and in 1990 moved to Merck. He is a past Council Member of the UK Academy of Medical Sciences and President Emeritus of the British Pharmacological Society. He is a Visiting Professor at the University of Bristol and was a member of the UK Government Advisory Council on the Misuse of Drugs from 2010 to 2019. He continues to serve on the ACMD Working Group on the Medicinal Uses of Cannabis and is a member of the drug misuse WG of Royal Pharmaceutical Society Science Committee.
Isaac Manke, Director: Dr. Manke has more than 15 years of experience in the life science industry as an investor, research analyst, consultant and scientist. Dr Manke is currently a General Partner at Acorn Bioventures, where he focuses on investing in small-cap public and private biotechnology companies. Prior to Acorn, Isaac spent 11 years at New Leaf Venture Partners (NLV). In addition to private venture investments, during his time at NLV, he also led the firm’s public investment activities initially with the public portfolio within NLV-II, and from 2014 through 2019, had day-to-day management and oversight responsibility for the NLV Biopharma Opportunities Funds. Isaac is a Director of Onkure therapeutics (Nasdaq : OKUR) and Q32 Bio (Nasdaq : QTTB). Dr Manke has been a board member or observer for several companies, including the boards of True North Therapeutics (acquired by Bioverativ) and Karos Pharmaceuticals (acquired by an undisclosed company). Previously, Isaac was an Associate in the Global Biotechnology Equity Research group at Sanford C. Bernstein. Isaac was also an Associate in the Biotechnology Equity Research group at Deutsche Bank and was a Senior Analyst at Health Advances, a biopharmaceutical and medical device strategy consulting firm. Isaac received a B.A. in Biology and a B.A. in Chemistry at Minnesota State University (Moorhead), and a Ph.D. in Biophysical Chemistry and Molecular Structure at the Massachusetts Institute of Technology, or MIT. Isaac’s discoveries led to several publications in top journals, including Science and Cell, and were selected by Science as one of the “2003: Signaling Breakthroughs of the Year”. These discoveries also resulted in four issued patents.
Jake Nunn, Director: Mr. Nunn has more than 30 years of experience in the life science industry as an investor, independent director, research analyst and investment banker. He is currently an independent advisor to life science companies and a partner at SR One Capital Management. Mr. Nunn was previously a venture advisor at New Enterprise Associates, or NEA, where he was a partner from 2006 to 2018, focusing on later-stage specialty pharmaceuticals, biotechnology and medical device investments and managing a number of NEA’s public investments in healthcare. Mr. Nunn is a Director of Regulus Therapeutics (Nasdaq: RGLS) and Zenas BioPharma, Inc. (Nasdaq: ZBIO). He previously was a Director of Dermira Inc. (acquired by Eli Lilly), Hyperion Therapeutics (acquired by Horizon Pharma PLC), TriVascular (acquired by Endologix), Aciex Therapeutics (acquired by Nicox SA), Transcept Pharmaceuticals (merged with Paratek) and a board observer at Vertiflex, Inc. (acquired by Boston Scientific). Prior to NEA, Mr. Nunn worked at MPM Capital as a Partner with the MPM BioEquities Fund, where he specialized in public, PIPE and mezzanine-stage life sciences investing. Previously, he was a healthcare research analyst and portfolio manager at Franklin Templeton Investments. Mr. Nunn was also an investment banker with Alex. Brown & Sons. He received an MBA from the Stanford Graduate School of Business and an AB in Economics from Dartmouth College. Mr. Nunn holds the Chartered Financial Analyst designation, is a member of the CFA Society of San Francisco, and recently completed the Stanford GSB Directors’ Consortium executive education program.
Family Relationships
There are no family relationships among any of our executive officers or directors.
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B. | Compensation of Executive Officers and Directors |
Board of Directors
The compensation of the non-executive board members mostly includes variable elements whilst executive board members are not remunerated as board member. The fixed element comprises a fixed annual monetary compensation per Board term from one general meeting of shareholders to the next. The variable element comprises a monetary compensation based on Board meeting attendance and the fair value of equity incentive units (share options and equity sharing certificates) and represents from 50% to 350% of fixed annual compensation.Social security contributions of the Company are accrued on the fixed and variable elements. Board member social security contributions are accrued on the fair value of equity incentive units. Equity incentive units are granted based on the discretion of the Board of Directors. Equity incentive units are granted to compensate for the dilutive effects of capital raising to ensure Board Members have sufficient unvested equity incentive units in accordance with external benchmarks. The most recent review of compensation for members of the Board took place in January 2024.
Executive Management
The compensation of members of the Executive Management consists of fixed and variable elements. The fixed element may include a base salary or a cash retainer paid under a consulting contract. The variable element may include performance-related cash or share based bonuses, consulting fees based on chargeable hours and equity incentive units (equity sharing certificates and share options). Company contributions to pension plans, death and invalidity insurances and social security contributions are accrued on all fixed and variable element compensation that relates to an employment relationship. Company social security contributions are accrued for all shares or equity incentive unit compensation. The amount of the fixed element depends on the position, responsibilities, experience and skills, and takes into account individual performance. The fixed element is reviewed at the end of each year by the Board. Any changes in the fixed elements are made effective in January of the following year. The variable elements are based on individual and company goals. The potential variable cash bonus is determined in the employment contract and in general is a percentage of the base salary. Where the Executive Manager has been engaged under a consulting contract, the variable element is based on the time spent at the contractually defined rate of remuneration. Every year, the Board decides on the total amount of variable elements including the amount of cash and equity incentive units to be granted for the previous year based on the achievement of Company and Individual goals. Equity incentive units are granted based on the discretion of the Board of Directors. Variable cash compensation paid to Executive Managers includes bonus and equity incentive units. The variable compensation of the CEO (Mr. Dyer) is entirely determined based on company goals and includes a cash bonus representing from 0% to 50% of base salary paid in 2024, exceptionally increased to 150% in 2024, as Mr Dyer is no longer remunerated for his role as Chief Executive Officer since April 2, 2024 with a bonus primarily related to the full 2023 year performance and equity incentive units representing from 0% to 200% of base salary paid in 2024. In 2024, our Chief Medical Officer (“CMO”), spent most of his time acting as Board member, therefore, he was only remunerated as a Board Member and received no remuneration for any consultancy services. In addition, equity incentive units are granted from time to time at the discretion of the Board of Directors. The variable compensation of the other Executive Managers includes a cash bonus representing from 0% to 25% of base salary paid in 2024, exceptionally increased to 100% in 2024 for the Executive Managers transferred to Neurosterix in 2024, and are no longer remunerated by Addex since April 2, 2024 with a bonus primarily related to the full 2023 year performance. Their performance is determined based on 20% individual goals and 80% company goals, and their equity incentive units represented 0% to 100% of base salary. In addition, the Board of Directors grants equity incentive units to Executive Managers to compensate for the dilutive effects of capital raising to ensure Executive Managers have sufficient unvested equity incentive units in accordance with external benchmarks.
The company goals for 2024 were established at the beginning of the year as follows:
Completion of research phase of GABAB PAM program and deliver development candidates for Indivior’s substance use disorder program and Addex independent chronic cough program. Complete the preclinical profiling of Addex development candidate in chronic cough and secure intellectual property for both programs. |
| 40 | % |
Secure the financial situation of the company |
| 30 | % |
Complete evaluation of potential indications for the future development of dipraglurant. Complete the evaluation of ADX71149 epilepsy data |
| 20 | % |
Maintain effective governance, regulation and administration |
| 10 | % |
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Executive Managers
Executive Managers are rewarded with a cash bonus based on the achievement of the corporate goals. The target bonus depends on the level of responsibility of the respective Executive Managers.
Equity incentive plans
The purpose of the Group’s share purchase, share option and equity sharing certificate programs (refer to note 15 of the consolidated financial statements) is to provide members of the Board of Directors, Executive Management, employees and certain consultants (together “Staff”) with an opportunity to benefit from the potential appreciation in the value of the Company’s shares, thus providing an increased incentive for participants to contribute to the future success and prosperity of the Group, enhancing the value of the shares for the benefit of the shareholders of the Group and increasing the ability of the Group to attract and retain individuals of exceptional skills. In addition, these plans provide the Group with a mechanism to engage services for non-cash consideration by settling them through a transfer of treasury shares under the share purchase plan based on predefined terms of the consulting contract. The grant of any share option or equity sharing certificate is at the discretion of the Board of Directors. Key factors considered by the Board of Directors in making grants of share options or equity sharing certificates are the amount of shareholder approved conditional capital, the benchmarking with other companies as well as individual performance (for further information on the detail and composition of the benchmark please refer to the paragraph review and approval process above). The strike price is determined by the Board of Directors and is primarily based on the closing price of the Company’s shares on the SIX Swiss Exchange on the grant date. In addition, the Group has implemented a staff retention plan which includes a deferred strike price payment plan (“DSPPP”) encouraging Board Members, Executive Managers and employees to exercise their share options or equity sharing certificates and become shareholders of the Company by allowing deferral of the obligation to pay the strike price on exercise (“Deferred Strike Price Payment Obligations”).
Indirect benefits
The Company may contribute to the pension plan and maintains certain insurance for death and invalidity for the members of the Executive Management. New entrants may be eligible for reimbursement of relocation costs, compensation for lost benefits or stock granted by a previous employer, international school for children or language courses for a limited time period. No Indirect benefits have been paid to Executive Management in 2024.
Compensation for the financial year under review
Measurement basis for compensation
The measurement basis for each component of compensation is described below:
| ● | Fixed cash compensation, variable cash compensation and shares acquired under the share purchase plan: accrual basis; |
| ● | Equity incentive units: fair value at the grant date in accordance with IFRS 2 valuation methodology; and |
| ● | Employers’ social security: accrual basis except for equity incentive units where the notional amount is calculated based on the fair value at grant date. |
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Compensation of the Board of Directors in 2024 and 2023
|
| Variable compensation | ||||||||
Fixed | number of | value of | ||||||||
2024 | cash | cash | equity | equity | Total | |||||
CHF |
| compensation |
| attendance |
| incentive units (1) |
| incentive units (2) |
| 2024 |
Vincent Lawton, chairman | 29,022 | 29,022 |
| 501,598 |
| 18,813 |
| 76,857 | ||
Raymond Hill, member | 18,018 | 18,018 |
| 273,107 |
| 10,243 |
| 46,279 | ||
Tim Dyer, member | — | — |
| — |
| — |
| — | ||
Roger Mills, member(3) | 12,937 | 12,937 |
| 50,000 |
| 1,875 |
| 27,749 | ||
Jake Nunn, member | 16,361 | 16,361 |
| 50,000 |
| 1,875 |
| 34,597 | ||
Isaac Manke, member | 16,361 | 16,361 |
| 50,000 |
| 1,875 |
| 34,597 | ||
Total | 92,699 | 92,699 |
| 924,705 |
| 34,681 |
| 220,079 | ||
| (1) | Equity incentive units include share options granted during the year under the Company’s share option plan (refer to note 15 of the consolidated financial statements). |
| (2) | The value of the equity incentive units include the fair value of the share options granted during the year under the Company’s share option plan (Refer to note 15 of the consolidated financial statements). |
| (3) | Roger Mills has only been remunerated as Board Member in 2024 as he spent most of his time acting as Board Member and not as Chief Medical Officer. |
| Variable compensation | |||||||||
number of | value of | |||||||||
2023 | Fixed cash | cash | equity | equity | ||||||
CHF |
| compensation |
| attendance |
| incentive units (1) |
| incentive units (2) |
| Total 2023 |
Vincent Lawton, chairman |
| 29,034 |
| 29,034 |
| 1,043,153 |
| 97,681 |
| 155,750 |
Raymond Hill, member |
| 18,231 |
| 18,231 |
| 567,969 |
| 53,185 |
| 89,646 |
Tim Dyer, member |
| — |
| — |
| — |
| — |
| — |
Roger Mills, member |
| — |
| — |
| — |
| — |
| — |
Jake Nunn, member |
| 16,370 |
| 16,370 |
| 91,323 |
| 8,551 |
| 41,291 |
Isaac Manke, member |
| 16,370 |
| 16,370 |
| 91,323 |
| 8,551 |
| 41,291 |
Total |
| 80,005 |
| 80,005 |
| 1,793,768 |
| 167,968 |
| 327,978 |
| (1) | Equity incentive units include share options granted during the year under the Company’s share option plan (refer to note 15 of the consolidated financial statements). |
| (2) | Value of equity incentive units include the fair value of share options granted during the year under the Company’s share option plan amounting to CHF 149,010 and the increase of CHF 18,958 in fair value of the equity incentive units whose grant conditions have been changed during the year (Refer to note 15 of the consolidated financial statements). |
Deferred Strike Price Payment Obligations of the Board of Directors:
December | December | |||
CHF | 31, 2024 | 31, 2023 | ||
Vincent Lawton, chairman |
| 235,219 |
| 235,219 |
Raymond Hill, member |
| 128,106 |
| 128,106 |
Tim Dyer, member |
| — |
| — |
Roger Mills, member (2) |
| 46,719 |
| — |
Jake Nunn, member |
| 20,598 |
| 20,598 |
Isaac Manke, member |
| 20,598 |
| 20,598 |
Total (1) |
| 451,239 |
| 404,521 |
| (1) | The amounts reported in this table correspond to the amounts owed by members of the Board of Directors in relation to Deferred Strike Price Payment Obligations (see note 15), which may be assimilated to loans to be disclosed in this Compensation report within the meaning of the Swiss Federal Code of Obligations. |
| (2) | Roger Mills has only been remunerated as Board Member in 2024, as he spent most of his time acting as Board Member and not as Chief Medical Officer. In 2023, Roger Mills was only remunerated for his activities as Chief Medical Officer. |
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Compensation to the Executive Management in 2024 and 2023
| Variable compensation | |||||||||
| number of | value of | ||||||||
Fixed | equity | equity | ||||||||
2024 | cash | incentive | incentive | Total | ||||||
CHF |
| compensation |
| Cash (2) |
| units (3) |
| units (4) |
| 2024 |
Total Executive Management (1) | 478,105 |
| 343,840 |
| 4,920,964 |
| 192,377 |
| 1,014,322 | |
| (1) | On April 2, 2024, the Group transferred a part of its business to Neurosterix Group (see note 23 of the consolidated financial statements included in this Annual Report on Form 20-F). As part of this transaction, all the Executive Managers have been transferred to Neurosterix Group and a service agreement was concluded between Addex Pharma SA and Neurosterix Pharma Sàrl allowing our CEO, Mr. Tim Dyer, and our Head of Translational Science, Mr Mikhail Kalinichev, to continue to work for Addex at zero cost for the Group. In 2024, the highest paid member of the Executive Management was our CEO, Mr. Tim Dyer, who received CHF 115,698 of fixed cash compensation, CHF 168,000 of variable cash compensation and 3,369,796 equity incentive units from January 1, 2024 to April 2, 2024. The fair value of equity incentive units including accrued social charges amounted to CHF 133,089 (see note 15 of the consolidated financial statements included in this Annual Report on Form 20-F). |
| (2) | Variable compensation in cash relates to bonuses paid to Executive Managers. |
| (3) | Equity incentive units include share options granted during the year under the Company’s share option plan. |
| (4) | The value of equity incentive units relates to the fair value of share options granted during the year under the Company’s share option plan (Refer to note 15 of the consolidated financial statements). |
|
| Variable compensation |
|
| ||||||
| number of | value of | ||||||||
equity | equity | |||||||||
2023 | Fixed cash | incentive | incentive | Total | ||||||
CHF |
| compensation |
| Cash (2) |
| units (3) |
| units (4) |
| 2023 |
Total Executive Management (1) |
| 1,275,109 |
| 226,288 |
| 9,492,817 |
| 935,516 |
| 2,436,913 |
| (1) | The highest paid member of Executive Management in 2023 was the CEO, Tim Dyer, who received CHF 471,969 of fixed cash compensation, CHF 109,151 of variable cash compensation and 7,008,033 equity incentive units. The fair value of equity incentive units including accrued social charges amounted to CHF 691,031 including CHF 613,036 for equity incentive units granted during the year and CHF 77,995 relating to the change in grant conditions made during the year (see note 15 of the consolidated financial statements included in this Annual Report on Form 20-F). |
| (2) | Variable compensation in cash relates to bonuses and compensation paid to Executive Managers under consulting contracts which provide hourly and daily rates with a monthly cap. |
| (3) | Equity incentive units include share options granted during the year under the Company’s share option plan. |
| (4) | The value of equity incentive units includes the fair value of share options granted during the year under the Company’s share option plan amounting to CHF 829,927 and the increase of CHF 105,589 in fair value of the equity incentive units whose grant conditions have been changed during the year (Refer to note 15 of the consolidated financial statements included in this Annual report on Form 20-F). |
Deferred Strike Price Payment Obligations of the Executive Management:
December 31, |
| December 31, | ||
CHF | 2024 | 2023 | ||
Total Executive Management (1) |
| 1,552,872 |
| 2,119,980 |
| (1) | The amounts reported in this table correspond to the amounts owed by Executive Managers at balance sheet date in relation to Deferred Strike Price Payment Obligations (see note 15 of the consolidated financial statements included in this Annual report on Form 20-F), which may be assimilated to loans to be disclosed in this Compensation Report within the meaning of the Swiss Federal Code of Obligations. The highest Deferred Strike Price Payment Obligation was attributable to our CEO Tim Dyer and amounted to CHF 1,524,093 as of December 31, 2024 and December 31, 2023. The total Deferred Strike Price Payment Obligation of the Executive Management decreased by CHF 567,108 between December 31, 2023 and December 31, 2024, as a result of (i) Dr. Robert Lütjens and Dr. Jean-Philippe Rocher stepping down from Executive Management on April 2, 2024 following the Neurosterix transaction, which caused a decrease of CHF 520,389 and (ii) CHF 46,719 relate Dr. Roger Mills being remunerated as Executive Manager in 2023, but only as a Board Member in 2024, which caused a decrease of CHF 46,719. |
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Addex’s shares held by members of the Board of Directors and Executive Management
| 2024 |
| 2023 | |
Number of Addex’s | Number of Addex’s | |||
Shares | Shares | |||
Tim Dyer |
| 16,848,979 |
| 16,848,979 |
Robert Lütjens(1) |
| — |
| 3,005,836 |
Jean-Philippe Rocher(1) |
| — |
| 2,541,197 |
Vincent Lawton |
| 2,507,987 |
| 2,507,987 |
Raymond Hill |
| 1,365,532 |
| 1,365,532 |
Roger Mills |
| 785,976 |
| 785,976 |
Mikhail Kalinichev |
| 306,765 |
| 306,765 |
Jake Nunn |
| 219,561 |
| 219,561 |
Isaac Manke |
| 219,561 |
| 219,561 |
Total |
| 22,254,361 |
| 27,801,394 |
| (1) | As of December 31, 2023, Dr Robert Lütjens and Dr Jean-Philippe Rocher were Executive Managers and held 3,005,836 and 2,541,197 shares respectively. As of December 31, 2024 no shares are reported as Drs Lütjens and Rocher were no longer Executive Managers as of such date. |
Addex’ share options held by Members of the Board and Executive Management
Number of | Number of | Total number of | ||||
| vested equity |
| unvested equity |
| equity incentive | |
December 31, 2024 | incentive units | incentive units | units | |||
Tim Dyer, Chief Executive Officer | 3,369,796 | — | 3,369,796 | |||
Lénaïc Teyssédou, Head of Finance | 340,278 | 262,630 | 602,908 | |||
Vincent Lawton, Chairman | 122,995 | 378,603 | 501,598 | |||
Raymond Hill | 66,967 | 206,140 | 273,107 | |||
Mikhail Kalinichev, Head of translational science | 200,000 | — | 200,000 | |||
Roger Mills, Chief Medical Officer | 12,260 | 37,740 | 50,000 | |||
Jake Nunn | 12,260 | 37,740 | 50,000 | |||
Isaac Manke | 12,260 | 37,740 | 50,000 | |||
Total | 4,136,816 | 960,593 | 5,097,409 |
As of December 31, 2023, members of the Board of Directors and Executive Management did not hold any equity incentive units.
C. | Board Practices. |
Composition of our Board of Directors
Our board of directors is currently composed of six members. As a foreign private issuer, under the listing requirements and rules of Nasdaq, we are not required to have independent directors on our board of directors, except that our audit committee is required to consist fully of independent directors. However, our board of directors has determined that Vincent Lawton, Jake Nunn and Isaac Manke do not have a relationship that would interfere with the exercise of independent judgment in carrying out the responsibilities of director and that each of these directors is “independent” as that term is defined under Nasdaq rules. There are no family relationships among any of our directors or senior management.
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Committees of our Board of Directors
The audit committee, which consists of Vincent Lawton, Isaac Manke and Jake Nunn, assists the board of directors in overseeing our accounting and financial reporting processes. Vincent Lawton serves as chairman of the audit committee. The audit committee consists exclusively of members of our board who are financially literate, and Jake Nunn is considered an “audit committee financial expert” as defined by applicable SEC rules and has the requisite financial sophistication as defined under the applicable Nasdaq rules and regulations. Our board of directors has determined that Vincent Lawton, Isaac Manke and Jake Nunn are independent directors under Nasdaq listing rules and under Rule 10A-3 under the Exchange Act. The audit committee is governed by a charter that complies with Nasdaq rules. The audit committee’s responsibilities include:
| ● | to review and assess the effectiveness of the statutory auditors and the group auditors, in particular their independence from Addex. In connection therewith, it reviews in particular additional assignments given by the Company or its subsidiaries. It may issue binding regulations or directives in connection with such additional assignments; |
| ● | to review and assess the scope and plan of the audit, the examination process and the results of the audit and to examine whether the recommendations issued by the auditors have been implemented by management; |
| ● | to review the auditors’ reports, to discuss their contents with the auditors and with the management; |
| ● | to approve the terms and conditions of the engagement of the auditors; |
| ● | to review the effectiveness of the internal audit function, its professional qualifications, resources and independence and its cooperation with external audit; |
| ● | to approve the annual internal audit concept and the annual internal audit report, including the responses of the management thereto |
| ● | to assess the risk assessment established by the management and the proposed measures to reduce risks; |
| ● | to assess the state of compliance with norms within Addex; |
| ● | to review in cooperation with the auditors, the CEO and Head of Finance whether the accounting principles and the financial control mechanism of Addex and its subsidiaries are appropriate in view of our size and complexity; |
| ● | to review the annual and interim statutory and consolidated financial statements intended for publication. It should discuss these with the CEO and the Head of Finance and, separately, with the head of external audit; |
| ● | to make a proposal to the Board with respect to these annual and interim statutory and consolidated financial statements; and |
| ● | the responsibility for approving the annual financial statements remains with the Board. |
Compensation Committee
The compensation committee, which consists of Vincent Lawton and Raymond Hill, advises the board in determining executive compensation. The compensation committee’s responsibilities include:
| ● | to review and assess on a regular basis the remuneration system of Addex (including the management incentive plans) and to make proposals in connection thereto to the Board; |
| ● | to recommend the terms of employment, in particular the remuneration package, of the CEO and to make proposals in relation to the remuneration of Directors; |
| ● | to recommend upon proposal of the CEO the terms of employment, in particular the remuneration package, of employees reporting directly to the CEO as well as review matters related to the compensation of other top managers, as well as the general employee compensation, benefit policies and HR practices of Addex; and |
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| ● | to make recommendations on the grant of options or other securities under any management incentive plan of Addex. |
D. | Employees. |
We had 2 full-time employees and consultants as of December 31, 2024 compared to 23 at December 31,2023. Our average headcount was 7 in 2024 as most of our employees have been transferred to Neurosterix Group on April 2, 2024 (compared to an average headcount of 24 in 2023). In addition to our employees, we engaged a number of consultants and service providers to complement our internal resources.
E. | Share Ownership. |
For information regarding the share ownership of our directors and executive officers, see “Item 6.B—Compensation” and “Item 7.A—Major Shareholders.”
| F. | Disclosure of a registrant’s action to recover erroneously awarded compensation |
Not applicable.
Item 7. Major Shareholders and Related Party Transactions
A. | Major shareholders. |
The following table sets forth information with respect to the beneficial ownership of our shares as of December 31, 2024 by:
| ● | each beneficial owner of 5% or more of our outstanding shares; |
| ● | each of our directors and executive officers; and |
| ● | all of our directors and executive officers as a group. |
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Beneficial ownership is determined in accordance with the rules of the SEC. These rules generally attribute beneficial ownership of securities to persons who possess sole or shared voting power or investment power with respect to those securities and include shares that can be acquired within 60 days of December 31, 2024. Percentage ownership calculations are based on 128,292,969 shares issued and outstanding, excluding 56,061,527 treasury shares indirectly held through our wholly-owned subsidiary Addex Pharma SA, as of December 31, 2024, plus consistent with SEC rules on disclosure of beneficial ownership, shares that each security holder has the ability to acquire within 60 days of December 31, 2024, due to outstanding equity interests becoming vested or exercisable. The percentage of shares beneficially owned, shown on the table, reflect these incremental shares that a security holder has the ability to acquire within the time frame noted.
| Number |
| Percentage |
| |
of shares | of shares | ||||
beneficially | beneficially | ||||
| owned |
| owned | ||
Executive Officers and Directors: |
|
|
|
| |
Tim Dyer (1) |
| 17,828,132 |
| 13.79 | % |
Vincent Lawton (2) |
| 2,651,595 |
| 2.06 | % |
Raymond Hill (3) |
| 1,443,723 |
| 1.12 | % |
Roger Mills |
| * |
| * | |
Isaac Manke |
| * |
| * | |
Jake Nunn |
| * |
| * | |
Mikhail Kalinichev | * | * | |||
Lénaïc Teyssédou |
| * |
| * | |
All current directors and executive officers as a group (8 persons) (4) |
| 23,916,163 |
| 18.40 | % |
* | Represents beneficial ownership of less than one percent. |
| (1) | Consist of 16,848,979 shares of which 6,288,411 are not freely tradable as of December 31, 2024, and 979,153 shares issuable upon the exercise of 964,777 outstanding options and 14,376 outstanding warrants. |
| (2) | Consist of 2,507,987 shares of which 945,257 are not freely tradable as of December 31, 2024, and 143,608 shares issuable upon the exercise of outstanding options. |
| (3) | Consist of 1,365,532 shares of which 514,453 are not freely tradable as of December 31, 2024, and 78,191 shares issuable upon the exercise of outstanding options. |
| (4) | Consist of 22,254,361 shares of which 8,092,991 are not freely tradable as of December 31, 2024 and 1,661,802 shares issuable upon the exercise of 1,647,426 outstanding options and 14,376 warrants. |
Significant Changes in Percentage Ownership
To our knowledge, other than as provided in the table above, our other filings with the SEC and under the heading “Related Party Transactions” in this Annual Report, there have been no significant changes in the percentage ownership held by our principal shareholders since January 1, 2025.
Voting Rights
As of December 31, 2024, our issued share capital as recorded in the commercial register was CHF 1,843,544.96, consisting of 184,354,496 ordinary shares with a nominal value of CHF 0.01 each. All shares rank pari passu with each other and no preferred shares exist.
Shareholders in the United States
As of December 31, 2024, to the best of our knowledge and assuming that all of our ordinary shares represented by ADSs are held by residents of the United States, we estimate that 13.39% of our issued ordinary shares (including ordinary shares underlying ADSs) as identified in publicly available filings were held in the United States.
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B. | Related Party Transactions. |
Since January 1, 2023, we engaged in the following transactions with (i) a company that is owned or controlled by one of our Directors or Corporate Officers (iii) a company in which one of our Directors or Corporate Officers are also a Director or Corporate Officer (iii) our major holders of more of 5% of our outstanding voting securities and their affiliates at the time or after the transaction.
Sale of our allosteric modulator drug discovery technology platform and pre-clinical programs
On April 2, 2024, we sold our allosteric modulator drug discovery technology platform and a portfolio of pre-clinical programs to Neurosterix Pharma Sàrl (Neurosterix), a new company funded by Perceptive Xontogeny Venture Fund II L.P, Perceptive Life Sciences Master fund Ltd and Acorn Bioventures 2, L.P (the “Transaction”). Acorn Bioventures 2, L.P is a fund where our Board Member Isaac Manke is a General Partner. As part of the Transaction, Addex received CHF 5.0 million in cash and shares representing 20% indirect equity interest in Neurosterix and concluded a service agreement allowing key members of Addex staff transferred to Neurosterix, including the Chief Executive Officer to support the activities of the Addex Group at zero cost. The fair value of the service agreement amounted to CHF 182,348. As of December 31, 2024, Neurosterix Group owed CHF 7,967 to Addex Group.
April 3, 2023 offering
On April 3, 2023, we sold to Armistice Capital Master Fund Ltd, or Armistice, 7,999,998 ordinary shares in the form of 66,666 ADSs at a price of USD 19.00 per ADS and 23,578,950 pre-funded warrants, in the form of 196,491 ADSs at a price of USD 18.80 per ADS with a remaining strike price of USD 0.20 per ADS. In addition, we granted Armistice Capital Master Fund Ltd, 31,578,948 warrants, in the form of 263,157 ADSs, with a strike price of USD 20.00 per ADS and an exercise period expiring on April 5, 2028. We also amended 9,230,772 warrants in the form of 76,923 ADSs issued on December 21, 2021 and 15,000,000 warrants in the form of 125,000 ADSs issued on July 26, 2022 to reduce the strike price to USD 20.00 per ADS and extend the exercise period to April 5, 2028. The pre-funded warrants are exercisable only if Armistice Capital Master Fund beneficially owns less than 9.99% of our outstanding shares whilst warrants are exercisable only if Armistice Capital Master Fund beneficially owns less than 4.99% of our outstanding shares. All of the pre-funded warrants were exercised in the year ended December 31, 2023. All the warrants remain unexercised at the issuance date of this annual report on form 20F.
| ADSs |
| ADS Pre-funded |
| ADS Warrants |
| ADS Warrants | |
purchased | warrants purchased | granted | repriced | |||||
(1) | (1) (2) | (1) (3) | (1) (3) | |||||
Major Shareholder at the time of the transaction |
| 66,666 |
| 196,491 |
| 263,157 |
| 201,923 |
Armistice Capital Master Fund Ltd (4) |
|
| (1) | Each ADS represents one hundred and twenty shares. |
| (2) | Pre-funded warrant ADSs are exercisable only if Armistice Capital Master Fund Ltd beneficially owns less than 9.99% of the outstanding shares. |
| (3) | Warrant ADSs are exercisable only if Armistice Capital Master Fund Ltd beneficially owns less than 4.99% of the outstanding shares. Warrant ADSs respectively granted and repriced on April 3, 2023, have both an exercise price of USD 20.00 per ADS and will expire on April 5, 2028. |
| (4) | Armistice Capital Master Fund Ltd, which is wholly owned by Armistice Capital LLC, was a holder of more than 5% of our outstanding shares on April 3, 2023. |
Director and Executive Officer Compensation
See “Item 6.B—Compensation of Directors and Executive Officers” for information regarding compensation of directors and executive officers.
We have entered into indemnification agreements with each of our directors and executive officers. These agreements require us to indemnify our directors and executive officers to the fullest extent permitted by law.
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Related-Party Transactions Policy
We have adopted a related-party transaction policy that sets forth our procedures for the identification, review, consideration and approval or ratification of related-party transactions. For purposes of our policy only, a related-party transaction is a transaction, arrangement or relationship, or any series of similar transactions, arrangements or relationships, in which we and any related parties are, were or will be participants, which are not in the ordinary course of business, (2) at arms’ length and (3) in which the amount involved exceeds CHF 120,000. Transactions involving compensation for services provided to us as an employee or director are not covered by this policy. For purposes of this policy, a related party is any executive officer, director (or nominee for director) or beneficial owner of more than 5% of any class of our voting securities, including any of their immediate family members and any entity owned or controlled by such persons.
Under the policy, if a transaction has been identified as a related-party transaction, including any transaction that was not a related-party transaction when originally consummated or any transaction that was not initially identified as a related-party transaction prior to consummation, our management must present information regarding the related-party transaction to our board of directors for review, consideration and approval. The presentation must include a description of, among other things, the material facts, the interests, direct and indirect, of the related parties, the benefits to us of the transaction and whether the transaction is on terms that are comparable to the terms available to or from, as the case may be, an unrelated third party or to or from employees generally. Under the policy, we will collect information that we deem reasonably necessary from each director, executive officer and, to the extent feasible, significant shareholder to enable us to identify any existing or potential related-party transactions and to effectuate the terms of the policy. In addition, our board of directors has adopted a Code of Business Conduct and Ethics, under which our employees and directors will have an affirmative responsibility to disclose any transaction or relationship that reasonably could be expected to give rise to a conflict of interest. In considering related-party transactions, our audit committee, or other independent body of our board of directors, will take into account the relevant available facts and circumstances including:
| ● | the risks, costs and benefits to us; |
| ● | the impact on a director’s independence in the event that the related party is a director, immediate family member of a director or an entity with which a director is affiliated; |
| ● | the availability of other sources for comparable services or products; and |
| ● | the terms available to or from, as the case may be, unrelated third parties or to or from employees generally. |
The policy requires that, in determining whether to approve, ratify or reject a related-party transaction, our audit committee, or other independent body of our board of directors, must consider, in light of known circumstances, whether the transaction is in, or is not inconsistent with, our best interests and those of our shareholders, as our audit committee, or other independent body of our board of directors, determines in the good faith exercise of its discretion.
C. | Interests of Experts and Counsel. |
Not applicable.
Item 8. Financial Information
A. | Consolidated Statements and Other Financial Information. |
Our consolidated financial statements are appended at the end of this Annual Report on Form 20-F, starting at page F-1, and are incorporated herein by reference.
Dividend Distribution Policy
We have never paid a dividend, and we do not anticipate paying dividends in the foreseeable future. We intend to retain all available funds and any future earnings to fund the development and expansion of our business.
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Under Swiss law, any dividend must be proposed by our board of directors and approved by a shareholders’ meeting. In addition, our auditors must confirm that the dividend proposal of our board of directors conforms to Swiss statutory law and our articles of association. A Swiss corporation may pay dividends only if it has sufficient distributable profits brought forward from the previous business years or if it has distributable reserves, each as evidenced by its audited standalone statutory balance sheet prepared pursuant to Swiss law and after allocations to reserves required by Swiss law and its articles of association have been deducted. Distributable reserves are generally booked either as “free reserves” or as “reserve from capital contributions”. Distributions out of issued share capital, which is the aggregate nominal value of a corporation’s issued shares, may be made only by way of a share capital reduction. See Exhibit 2.4 “Description of Securities”.
B. | Significant Changes. |
Not applicable
Item 9. The Offer and Listing.
A. | Offer and Listing Details. |
Our shares have been listed on Nasdaq Capital Market, or Nasdaq, under the symbol “ADXN” since January 29, 2020 and on the SIX Swiss Exchange, or SIX, under the symbol “ADXN” since May 22, 2007.
B. | Plan of Distribution. |
Not applicable.
C. | Markets. |
Our shares have been listed on Nasdaq Capital Market, or Nasdaq, under the symbol “ADXN” since January 29, 2020 and on the SIX Swiss Exchange, or SIX, under the symbol “ADXN” since May 22, 2007.
D. | Selling Shareholders. |
Not applicable.
E. | Dilution. |
Not applicable.
F. | Expenses of the Issue. |
Not applicable.
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Item 10. Additional Information.
A. | Share Capital. |
Not applicable.
B. | Memorandum and Articles of Association. |
See the information set forth in Exhibit 2.4 “Description of Securities,” and the copy of our Articles of Association filed as Exhibit 1.1, which are each incorporated herein by reference.
C. | Material Contracts. |
Service Agreement
Pursuant to a service agreement dated April 2, 2024, Neurosterix agreed to allow some employees and executive managers to dedicate a portion of their time for us at zero cost and provide us the access of the administrative offices located at Chemin des Mines 9, Geneva.
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At the Market Offering (ATM) Programs
On June 29, 2021, we entered into a Controlled Equity OfferingSM Sales Agreement with Cantor Fitzgerald & Co. to sell treasury shares from time to time at our discretion under an “at the market offering” (ATM) program, or the Cantor Sales Agreement. The prospectus supplement for the Cantor Sales Agreement was terminated on October 15, 2021 and the Cantor Sales Agreement was terminated on January 29, 2024. From June 29, 2021 through December 13, 2021, the Company issued an aggregate of 1,200 ADSs representing 7,200 ordinary shares at an average price of USD 10.12 per ADS through the Sales Agreement Prospectus, resulting in gross proceeds to the Company for approximately USD 12 thousand. No ADSs were issued under the Cantor Sales Agreement from December 13, 2021 through the termination of the Cantor Sales Agreement on January 29, 2024.
On January 30, 2024, we entered into an At the Market Offering Agreement with H.C. Wainwright & Co., LLC to sell treasury shares from time to time at our discretion under an ATM program, or the Wainwright Sales Agreement. The agreement with H.C Wainwright has been suspended on April 7, 2024 following the expiration of the prospectus. From January 30, 2024 to April 7, 2024, we have not sold any ADSs under the Wainwright Sales Agreement.
Sale Agency Agreement
On August 24, 2020, we entered into a sale agency agreement with Kepler Cheuvreux to sell treasury shares on Six Swiss Exchange from time to time. The initial termination date of March 31, 2021 has been extended several times to December 31, 2026, with substantive terms aligned with the original agreement. From inception of the sale agency agreement with Kepler Cheuvreux to the publication of our Annual Report on Form 20-F, we generated gross proceeds of CHF 2.7 million.
Collaboration Agreement with Indivior for Development of Novel GABAB PAM Compounds, including for the Treatment of Addiction and Other CNS Diseases
In January 2018, we entered into an agreement with Indivior for the discovery, development and commercialization of novel GABAB PAM compounds for the treatment of addiction and other CNS diseases. This agreement included the selected clinical candidate, ADX71441. In addition, Indivior agreed to fund a research program at Addex to discover novel GABAB PAM compounds.
Indivior has sole responsibility, including funding liability, for development of selected compounds under the agreement through preclinical and clinical trials, as well as registration procedures and commercialization, if any, worldwide. Indivior has the right to design development programs for selected compounds under the agreement. Through our participation in a joint development committee, we review, in an advisory capacity, any development programs designed by Indivior. However, Indivior has authority over all aspects of the development of such selected compounds.
Under terms of the agreement, we have granted Indivior an exclusive license to use relevant patents and know-how in relation to the development and commercialization of drug candidates selected by Indivior. Subject to agreed conditions, Addex and Indivior jointly own all intellectual property rights that are jointly developed, and Addex or Indivior individually own all intellectual property rights that Addex or Indivior develop individually. Addex has retained the right to select compounds from the research program for further development in areas outside the interest of Indivior including chronic cough. Under certain conditions, but subject to certain consequences, Indivior may terminate the agreement.
In January 2018, under terms of the agreement, we received a non-refundable upfront fee of USD 5.0 million for the right to use the clinical candidate, ADX71441, including all materials and know-how related to this clinical candidate. On February 14, 2019, Indivior terminated the development of their selected compound, ADX71441.
Separately, Indivior funds research at Addex, based on a research plan to be mutually agreed between the parties, to discover novel GABAB PAM compounds. These future novel GABAB PAM compounds, if selected by Indivior, become licensed compounds. We agreed with Indivior to an initial research term and duration of two years with a funding of USD 4 million over the period for our R&D costs incurred, that can be extended by twelve-month increments. Following Indivior’s selection of one newly identified compound, Addex has the right to also select one additional newly identified compound. Addex is responsible for the funding of all development and commercialization costs of its selected compounds and Indivior has no rights to the Addex selected compounds.
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The initial two-year research term was expected to run from May 2018 to April 2020. In 2019, Indivior agreed an additional research funding of USD 1.6 million, for the research period. On October 30, 2020, the research term was extended until June 30, 2021 and Indivior agreed to additional research funding of USD 2.8 million. Effective May 1, 2021, the research term was extended until July 31, 2022 and Indivior agreed additional research funding of CHF 3.7 million, of which CHF 2.7 million has been paid to us and CHF 1.0 million paid directly by Indivior to third party suppliers that are supporting the funded research program. In August 2022, the research agreement was extended until March 31, 2023 with additional research funding of CHF 0.85 million. The reserved indications, where Addex retains exclusive rights to develop its own independent GABAB PAM program, were also expanded to include chronic cough. Effective November 1, 2022 the research term was extended until June 30, 2023 and Indivior agreed to additional research funding of CHF 0.95 million. Effective July 1, 2023, the research term was extended until June 30, 2024 and Indivior agreed to additional research funding of CHF 2.7 million including CHF 1.1 million received directly by us and CHF 1.6 million paid directly by Indivior to third party suppliers that are supporting the funded research program.
On August 27, 2024, Indivior selected a compound for future development in substance use disorder and now undertake all future development of their selected compound. Under the terms of the agreement, we have also exercised our right to select a compound to advance our own independent GABAB PAM program for the treatment of chronic cough. In addition, we are as well eligible for payments on successful achievement of pre-specified clinical, regulatory and commercial milestones totaling USD 330 million. In addition, we are eligible for tiered royalties from high single digits to low double digits on net sales of applicable products on a country-by country-basis. The term of the royalty for each licensed product in any particular country commences on such product’s launch and ends on the latest of ten -year anniversary of launch, expiration of certain applicable patent rights, and expiration of certain applicable marketing or data exclusivity periods.
Indivior may terminate the Agreement in its entirety or with respect to one or more countries or products upon 90 days’ prior written notice prior to receipt of marketing approval for product candidates or twelve months’ prior written notice after the receipt of marketing approval.
Addex may terminate the agreement if Indivior commits a material breach of the agreement and fails to cure such breach within 90 days of Addex’s written notification to Indivior or fails to cure breaches to any payment obligations breach within 30 days, subject to certain conditions.
Collaboration Agreement with Janssen for Development of Novel mGlu2 PAM Compounds, including ADX71149, for the Treatment of CNS and Related Diseases
On December 31, 2004, we entered into a collaboration and license agreement with Janssen Pharmaceuticals, Inc., or Janssen, for the discovery, development and commercialization of novel mGlu2 PAM compounds for the treatment of CNS and related diseases. We agreed with Janssen to an initial research term and duration of two years that could have been extended if parties mutually agreed thereto in writing. The agreement was not extended beyond 2007. ADX71149 is one of the drug candidates discovered and selected for development by Janssen under the agreement. In 2012, Janssen announced completion of a Phase 2a clinical trial in Europe with ADX71149 for the treatment of schizophrenia demonstrating proof of principal in patients with negative symptoms of schizophrenia, such as apathy, social withdrawal, loss of emotional expression or sleep disorders. Janssen also conducted a Phase 2a clinical trial with ADX71149 for the treatment of patients with anxious depression, which failed to show statistically significant effects. In 2015 and 2018, Janssen scientists published studies demonstrating synergies with Keppra (a globally commercialized antiepileptic drug) in preclinical models of epilepsy. Janssen conducted a placebo-controlled Phase 2a proof of concept clinical trial of ADX71149 in epilepsy patients from 2021 to 2024. Janssen concluded that the Phase 2 study did not achieve statistical significance for the primary endpoint of time for patients to reach baseline seizure count when ADX71149 was added to standard of care.
On April 17, 2025, we announced that our partner Janssen terminated our partnership agreement and returned to us the program including all related intellectual property to the Group. We are currently evaluating the future development of ADX71149.
Under our agreement with Janssen, we had granted Janssen an exclusive license to use relevant patents and know-how in relation to the development and commercialization of drug candidates selected by Janssen under the agreement and a non-exclusive worldwide license to conduct research on the collaboration compounds using relevant patents and know-how.
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Janssen had sole responsibility, including funding liability, for development of selected compounds under the agreement through preclinical and clinical trials, as well as registration procedures and commercialization, if any, in the United States, Japan, the United Kingdom, Germany, France, Spain and Italy. Janssen had the right to design development programs for selected compounds under the agreement. Through our participation in a joint development committee, we reviewed, in an advisory capacity, any development programs designed by Janssen. However, Janssen had authority over all aspects of the development of selected compounds.
Under the terms of the Janssen agreement, we received an upfront fee of € 4.6 million and research funding of € 6.4 million during the research period, which ran from 2005 to 2007. In addition, we were eligible for payments on successful achievement of pre-specified clinical and regulatory milestones. We were also eligible for low double digit royalties on net sales of applicable products on a country-by country-basis and on a product by product basis, for a period commencing on the date of first sale and ending upon the latest of the expiration of twelve years from the date of first sale of a product in a given country or the last to expire of our patents containing a claim covering composition of compound comprised in a product sold by Janssen, its affiliates or sublicensees in such country. We received a € 1.5 million milestone payment in relation to the entry of ADX71149 into Phase 1 in July 2009 and a € 2.6 million milestone payment in relation to the entry of ADX71149 into Phase 2 in June 2011. We were eligible for a further €109 million in success-based development and regulatory milestones and low double-digit royalties on net sales.
For additional information on our material contracts, please see “Item 4. Information on the Company,” “Item 6. Directors, Senior Management and Employees,” and “Item 7.B. Related Party Transactions” of this Annual Report on 20-F.
D. | Exchange Controls. |
There are no Swiss governmental laws, decrees, regulations or other legislation that restrict, in a manner material to us, the export or import of capital, including any foreign exchange controls, or that generally affect the remittance of dividends or other payments to non-residents or non-citizens of Switzerland who hold our shares.
E. | Taxation. |
Material U.S. Federal Income Tax Considerations for U.S. Holders
The following is a description of the material U.S. federal income tax consequences to the U.S. Holders (as defined below) of acquiring, owning and disposing of our shares or ADSs representing our shares. It is not a comprehensive description of all tax considerations that may be relevant to a particular person’s decision to acquire securities. This discussion applies only to U.S. Holders that are initial purchasers of our ADSs representing our shares and that will hold such ADSs as a capital asset for tax purposes (generally, property held for investment). In addition, it does not describe all of the tax consequences that may be relevant in light of a U.S. Holder’s particular circumstances, including state and local tax consequences, estate tax consequences, alternative minimum tax consequences, the potential application of the Medicare contribution tax, and tax consequences applicable to U.S. Holders subject to special rules, such as:
| ● | banks, insurance companies, and certain other financial institutions; |
| ● | U.S. expatriates and certain former citizens or long-term residents of the United States; |
| ● | dealers or traders in securities who use a mark-to-market method of tax accounting; |
| ● | persons holding our shares or ADSs representing our shares as part of a hedging transaction, “straddle,” wash sale, conversion transaction or integrated transaction or persons entering into a constructive sale with respect to our shares or ADSs representing our shares; |
| ● | persons whose “functional currency” for U.S. federal income tax purposes is not the U.S. dollar; |
| ● | brokers, dealers or traders in securities, commodities or currencies; |
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| ● | tax-exempt entities or government organizations; |
| ● | S corporations, partnerships, or other entities or arrangements classified as partnerships for U.S. federal income tax purposes; |
| ● | regulated investment companies or real estate investment trusts; |
| ● | persons who acquired our shares or ADSs representing our shares pursuant to the exercise of any employee stock option or otherwise as compensation; |
| ● | persons required under Section 451(b) of the Code to conform to the timing of income accruals with respect to our ADSs representing our shares or the shares represented by such ADSs; |
| ● | persons that own or are deemed to own (including by attribution) ten percent or more of our shares by voting power or value; and |
| ● | persons holding our shares or ADSs representing our shares in connection with a trade or business, permanent establishment, or fixed base outside the United States. |
Holders of our shares or ADSs representing our shares who fall within one of the categories above are advised to consult their tax advisor regarding the specific tax consequences which may apply to their particular situation.
If an entity that is classified as a partnership for U.S. federal income tax purposes holds our shares or ADSs representing our shares, the U.S. federal income tax treatment of a partner will generally depend on the status of the partner and the activities of the partnership. Partnerships holding our shares or ADSs representing our shares and partners in such partnerships are encouraged to consult their tax advisers as to the particular U.S. federal income tax consequences of holding and disposing of such shares or ADSs representing our shares.
The discussion is based on the Internal Revenue Code of 1986, as amended, or the Code, administrative pronouncements, judicial decisions, final, temporary and proposed Treasury Regulations, and the Convention between the United States of America and the Swiss Confederation for the Avoidance of Double Taxation with Respect to Taxes on Income, signed on October 2, 1996, as amended and currently in force, or the U.S.-Swiss Tax Treaty, in each case, as in effect and available on the date hereof. All of the foregoing are subject to change, which change could apply retroactively, and to differing interpretations, all of which could affect the tax considerations described below. There can be no assurances that the U.S. Internal Revenue Service, or the IRS, will not take a different position concerning the tax consequences of the acquisition, ownership and disposition of our shares or ADSs representing our shares or that such a position would not be sustained by a court. We have not obtained, nor do we intend to obtain, a ruling with respect to the U.S. federal income tax considerations in the purchase, ownership or disposition of our shares or ADSs representing our shares. Accordingly, holders should consult their own tax advisors concerning the U.S. federal, state, local and non-U.S. tax consequences of acquiring, owning and disposing of our shares or ADSs representing our shares in their particular circumstances.
A “U.S. Holder” is a holder who, for U.S. federal income tax purposes, is a beneficial owner of our shares or ADSs representing our shares who is eligible for the benefits of the U.S.-Swiss Tax Treaty and is:
| ● | a citizen or individual resident of the United States; |
| ● | a corporation, or other entity taxable as a corporation, created or organized in or under the laws of the United States, any state therein or the District of Columbia; |
| ● | an estate the income of which is subject to U.S. federal income taxation regardless of its source; or |
| ● | a trust if (1) a U.S. court is able to exercise primary supervision over the administration of the trust and one or more U.S. persons have authority to control all substantial decisions of the trust or (2) the trust has a valid election to be treated as a U.S. person under applicable U.S. Treasury Regulations. |
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U.S. Holders are encouraged to consult their tax advisers concerning the U.S. federal, state, local and foreign tax consequences of owning and disposing of our shares or ADSs representing our shares in their particular circumstances.
The discussion below assumes that the representations contained in the deposit agreement are true and that the obligations in the deposit agreement and any related agreement will be complied with in accordance with their terms. Generally, a holder of ADSs should be treated for U.S. federal income tax purposes as the beneficial owner of the underlying ordinary shares represented by the ADS. Accordingly, no gain or loss will be recognized if a U.S. Holder exchanges ADSs for the underlying shares representing those ADSs. The U.S. Treasury has expressed concern that parties to whom ADSs are released before shares are delivered to the Depositary or intermediaries in the chain of ownership between holders and the issuer of the security underlying the ADSs, may be taking actions that are inconsistent with the claiming of foreign tax credits by U.S. Holders of ADSs. These actions would also be inconsistent with the claiming of the reduced rate of tax, described below, applicable to dividends received by certain non-corporate U.S. Holders. Accordingly, the creditability of non-U.S. withholding taxes (if any), and the availability of the reduced tax rate for dividends received by certain non-corporate U.S. Holders, each described below, could be affected by actions taken by such parties or intermediaries.
Passive Foreign Investment Company Rules
Based on the nature and composition of our income, assets and activities for our taxable year ended December 31, 2024, we believe that we were classified as a PFIC for our taxable year ended December 31, 2024 and may be a PFIC in future years. The application of the PFIC rules is subject to uncertainty in several respects, and therefore, no assurances can be provided with respect to our PFIC status for our taxable year ended December 31, 2024 or with regard to our PFIC status in any other past, the current or any future taxable year.
If we are classified as a PFIC in any taxable year, a U.S. Holder will be subject to special rules generally intended to reduce or eliminate any benefits from the deferral of U.S. federal income tax that a U.S. Holder could derive from investing in a non-U.S. company that does not distribute all of its earnings on a current basis.
A non-U.S. corporation will be classified as a PFIC for any taxable year in which, after applying certain look-through rules with respect to the income and assets of its subsidiaries, either:
| ● | at least 75% of its gross income is “passive income”; or |
| ● | at least 50% of its gross assets (determined on the basis of a quarterly weighted average) is attributable to assets that produce “passive income” or are held for the production of “passive income.” |
For this purpose, cash generally is a passive asset and passive income generally includes dividends, interest, royalties and rents (other than royalties and rents derived in the active conduct of a trade or business and not derived from a related person). We will be treated as owning our proportionate share of the assets and earning our proportionate share of the income of any other corporation or partnership, the equity of which we own, directly or indirectly, 25% or more (by value).
The determination of whether we are a PFIC is a fact-intensive determination made on an annual basis and the applicable law is subject to varying interpretation. In particular, the characterization of our assets as active or passive may depend in part on our current and intended future business plans, which are subject to change. In addition, for our current and future taxable years, the total value of our assets for PFIC testing may be determined in part by reference to the market price of our ordinary shares or ADSs from time to time, which may fluctuate considerably. If we are a PFIC for any taxable year during which a U.S. Holder holds our shares or ADSs representing our shares, such U.S. Holder will be subject to special tax rules discussed below and could suffer adverse tax consequences.
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Under the income test, our status as a PFIC depends on the composition of our income which will depend on the transactions we enter into in the future and our corporate structure. The composition of our income and assets is also affected by how, and how quickly, we spend the cash we raise in any offering. Our U.S. counsel expresses no opinion with respect to our PFIC status for our taxable year ended December 31, 2024 or any future taxable year.
A separate determination must be made after the close of each taxable year as to whether we are a PFIC for that year. As a result, our PFIC status may change from year to year and we have not yet made any determination as to our expected PFIC status for the current year.
The total value of our assets for purposes of the asset test generally will be calculated using the market price of our shares or ADSs representing our shares, which may fluctuate considerably. Fluctuations in the market price of the shares or ADSs representing our shares may result in our being a PFIC for any taxable year. Because of the uncertainties involved in establishing our PFIC status, our United States tax counsel expresses no opinion regarding our PFIC status for our taxable year ended December 31, 2024 or our current, or any other past or future taxable year.
If we are classified as a PFIC in any year with respect to which a U.S. Holder owns our shares or ADSs representing our shares, we will continue to be treated as a PFIC with respect to such U.S. Holder in all succeeding years during which the U.S. Holder owns the shares or ADSs representing our shares, regardless of whether we continue to meet the tests described above unless (i) we cease to be a PFIC and the U.S. Holder has made a “deemed sale” election under the PFIC rules, or (ii) the U.S. Holder makes a “QEF Election” (defined below) or is eligible to make and makes a mark-to-market election (as described below), with respect to all taxable years during such U.S. Holder’s holding period in which we are a PFIC. If the “deemed sale” election is made, a U.S. Holder will be deemed to have sold the shares or ADSs representing our shares the U.S. Holder holds at their fair market value as of the date of such deemed sale and any gain from such deemed sale would be subject to the rules described below. After the deemed sale election, so long as we do not become a PFIC in a subsequent taxable year, the U.S. Holder’s shares or ADSs representing our shares with respect to which such election was made will not be treated as shares in a PFIC and the U.S. Holder will not be subject to the rules described below with respect to any “excess distribution” the U.S. Holder receives from us or any gain from an actual sale or other disposition of the shares or ADSs representing our shares. U.S. Holders should consult their tax advisors as to the possibility and consequences of making a deemed sale election if such election becomes available.
For each taxable year we are treated as a PFIC with respect to U.S. Holders, U.S. Holders will be subject to special tax rules with respect to any “excess distribution” such U.S. Holder receives and any gain such U.S. Holder recognizes from a sale or other disposition (including a pledge) of our shares or ADSs representing our shares, unless (i) such U.S. Holder makes a QEF Election or (ii) our shares or ADSs representing our shares constitute “marketable” securities, and such U.S. Holder makes a mark-to-market election as discussed below. Distributions a U.S. Holder receives in a taxable year that are greater than 125% of the average annual distributions a U.S. Holder received during the shorter of the three preceding taxable years or the U.S. Holder’s holding period for the shares or ADSs representing our shares will be treated as an excess distribution. Under these special tax rules:
| ● | the excess distribution or gain will be allocated ratably over a U.S. Holder’s holding period for the shares or ADSs representing our shares; |
| ● | the amount allocated to the current taxable year, and any taxable year prior to the first taxable year in which we became a PFIC, will be treated as ordinary income; and |
| ● | the amount allocated to each other year will be subject to the highest tax rate in effect for that year and the interest charge generally applicable to underpayments of tax will be imposed on the resulting tax attributable to each such year. |
The tax liability for amounts allocated to years prior to the year of disposition or “excess distribution” cannot be offset by any net operating losses for such years, and gains (but not losses) realized on the sale of the shares or ADSs representing our shares cannot be treated as capital gains, even if a U.S. Holder holds the shares or ADSs representing our shares as capital assets. In addition, dividend distributions made to you will not qualify for the lower rates of taxation applicable to qualified dividends discussed below under “Taxation of Distributions.”
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If we are a PFIC, a U.S. Holder will generally be subject to similar rules with respect to distributions we receive from, and our dispositions of the stock of, any of our direct or indirect subsidiaries that also are PFICs, as if such distributions were indirectly received by, and / or dispositions were indirectly carried out by, such U.S. Holder. U.S. Holders should consult their tax advisors regarding the application of the PFIC rules to our subsidiaries.
U.S. Holders can avoid the interest charge on excess distributions or gain relating to our shares or ADSs representing our shares by making a mark-to-market election with respect to the shares or ADSs representing our shares, provided that the shares or ADSs representing our shares are “marketable.”
Shares or ADSs representing our shares will be marketable if they are “regularly traded” on certain U.S. stock exchanges or on a foreign stock exchange that meets certain conditions. For these purposes, the shares or ADSs representing our shares will be considered regularly traded during any calendar year during which they are traded on, other than in de minimis quantities, at least 15 days during each calendar quarter. Any trades that have as their principal purpose meeting this requirement will be disregarded. Our ADSs representing our shares are listed on Nasdaq, which is a qualified exchange for these purposes. Consequently, if our ADSs representing our shares remain listed on Nasdaq and are regularly traded, and you are a U.S. Holder of ADSs representing our shares, we expect the mark-to-market election would be available to you if we are a PFIC. Each U.S. Holder should consult its tax advisor as to the whether a mark-to-market election is available or advisable with respect to the shares or ADSs representing our shares. It should be noted that only our ADSs representing our shares and not our shares are listed on Nasdaq. Consequently, our shares may not be marketable if SIX Swiss Exchange (where our shares are listed) does not meet the applicable requirements. U.S. Holders should consult their tax advisors regarding the availability of the mark-to-market election for shares that are not represented by ADSs.
A U.S. Holder that makes a mark-to-market election must include in ordinary income for each year an amount equal to the excess, if any, of the fair market value of our shares or ADSs representing our shares at the close of the taxable year over the U.S. Holder’s adjusted tax basis in the shares or ADSs representing our shares. An electing holder may also claim an ordinary loss deduction for the excess, if any, of the U.S. Holder’s adjusted basis in the shares or ADSs representing our shares over the fair market value of the shares or ADSs representing our shares at the close of the taxable year, but this deduction is allowable only to the extent of any net mark-to-market gains for prior years. Gains from an actual sale or other disposition of the shares or ADSs representing our shares will be treated as ordinary income, and any losses incurred on a sale or other disposition of the shares will be treated as an ordinary loss to the extent of any net mark-to-market gains for prior years. Once made, the election cannot be revoked without the consent of the IRS unless the shares or ADSs representing our shares cease to be marketable.
However, a mark-to-market election generally cannot be made for equity interests in any lower-tier PFICs that we own, unless shares of such lower-tier PFIC are themselves “marketable.” As a result, even if a U.S. Holder validly makes a mark-to-market election with respect to our shares or ADSs representing our shares, the U.S. Holder may continue to be subject to the PFIC rules (described above) with respect to its indirect interest in any of our investments that are treated as an equity interest in a PFIC for U.S. federal income tax purposes. U.S. Holders should consult their tax advisors as to the availability and desirability of a mark-to-market election, as well as the impact of such election on interests in any lower-tier PFICs.
Alternatively, a U.S. Holder can make an election, if we provide the necessary information, to treat us and each lower-tier PFIC as a qualified electing fund, or a QEF Election, in the first taxable year we (and our relevant subsidiaries) are treated as a PFIC with respect to the U.S. Holder. If such election remains in place while we and any lower-tier PFIC subsidiaries are PFICs, we and our subsidiaries will not be treated as PFICs with respect to such U.S. Holder. A U.S. Holder must make the QEF Election for us and for each of our subsidiaries that is a PFIC by attaching a separate properly completed IRS Form 8621 for each such PFIC to the U.S. Holder’s timely filed U.S. federal income tax return. For each year in which we are a PFIC, we expect to provide U.S. Holders, upon request, a “PFIC Annual Information Statement”, with the information required to allow U.S. Holders to make a QEF Election for United States federal income tax purposes.
If a U.S. Holder makes a QEF Election with respect to a PFIC, then in lieu of the tax consequences described above, the U.S. Holder will be currently taxable on its pro rata share of the PFIC’s ordinary earnings and net capital gain (at ordinary income and capital gain rates, respectively) for each taxable year that the entity is classified as a PFIC. If a U.S.
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Holder makes a QEF Election with respect to us, any distributions paid by us out of our earnings and profits that were previously included in the U.S. Holder’s income under the QEF Election would not be taxable to the holder. However, a U.S. Holder can only make a QEF election with respect to ADSs in a PFIC if such company agrees to furnish such U.S. Holder with certain tax information annually. For our taxable year ended December 31, 2024, we intend to provide U.S. Holders, upon request, such information as the IRS may require, including a PFIC annual information statement, in order to enable U.S. Holders to make a QEF Election. However, there is no assurance that we will have timely knowledge of our status as a PFIC in the future or that the required information will be provided at a time that will permit a U.S. Holder to make or maintain a QEF Election. We have not determined if we will provide U.S. Holders such information for any subsequent taxable year. A U.S. Holder will increase its tax basis in its shares or ADSs representing our shares by an amount equal to any income included under the QEF Election and will decrease its tax basis by any amount distributed on the shares or ADSs representing our shares that is not included in the holder’s income. However, we do not currently expect to pay distributions with respect to our ADSs. U.S. Holders should consult with their tax advisors regarding the implications of owning stock in a PFIC, including whether and how to make and maintain a QEF Election. In addition, a U.S. Holder will recognize capital gain or loss on the disposition of shares or ADSs representing our shares in an amount equal to the difference between the amount realized and the holder’s adjusted tax basis in the shares or ADSs representing our shares. U.S. Holders should note that if they make QEF Elections with respect to us and lower-tier PFICs, they may be required to pay U.S. federal income tax with respect to their shares or ADSs representing our shares for any taxable year significantly in excess of any cash distributions (which may be zero) received on the shares or ADSs representing our shares for such taxable year. U.S. Holders should consult their tax advisors regarding making QEF Elections in their particular circumstances. If a U.S. Holder does not make and maintain a QEF election for the U.S. Holder’s entire holding period for the shares or ADSs representing our shares by making the election for the first year in which the U.S. Holder owns the shares or ADSs representing our shares, the U.S. Holder will be subject to the adverse PFIC rules discussed above unless the U.S. Holder can properly make a ‘purging election’ with respect to the shares or ADS representing our shares in connection with the U.S. Holder’s QEF Election. A purging election may require the U.S. Holder to recognize taxable gain on the U.S. Holder’s shares or ADSs representing our shares. No purging election is necessary for a U.S. Holder that timely makes a QEF election for the first year in which the U.S. Holder acquired our shares or ADSs representing our shares.
The U.S. federal income tax rules relating to PFICs are complex. Prospective U.S. investors are urged to consult their own tax advisors with respect to the acquisition, ownership and disposition of our shares or ADSs representing our shares, the consequences to them of an investment in a PFIC, any elections available with respect to our shares or ADSs representing our shares and the IRS information reporting obligations with respect to the acquisition, ownership and disposition of our shares or ADSs representing our shares.
Taxation of Distributions
Subject to the discussion above under “Passive Foreign Investment Company Rules,” distributions paid on our shares or ADSs representing our shares will generally be treated as dividends to the extent paid out of our current or accumulated earnings and profits (as determined under U.S. federal income tax principles). Because we may not calculate our earnings and profits under U.S. federal income tax principles, we expect that distributions generally will be reported to U.S. Holders as dividends. Subject to applicable limitations, dividends paid to certain non-corporate U.S. Holders may be taxable at preferential rates applicable to “qualified dividend income” if we are a “qualified foreign corporation” and certain other requirements (discussed below) are met. A non-U.S. corporation (other than a corporation that is classified as a PFIC for the taxable year in which the dividend is paid or the preceding taxable year) generally will be considered to be a qualified foreign corporation (a) if it is eligible for the benefits of a comprehensive tax treaty with the United States which the Secretary of Treasury of the United States determines is satisfactory for purposes of this provision and which includes an exchange of information provision, or (b) with respect to any dividend it pays on ADSs representing our shares which are readily tradable on an established securities market in the United States.
ADSs representing our shares are listed on Nasdaq, which is an established securities market in the United States, and we expect the ADSs representing our shares to be readily tradable on Nasdaq. There can be no assurance that the ADSs representing our shares will be considered readily tradable on an established securities market in the United States in later years. The Company, which is incorporated under the laws of Switzerland, believes that it qualifies as a resident of Switzerland for purposes of, and is eligible for the benefits of, the U.S.-Swiss Tax Treaty, although there can be no assurance in this regard. Further, the IRS has determined that the U.S.-Swiss Tax Treaty is satisfactory for purposes of the qualified dividend rules and that it includes an exchange-of-information program.
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Therefore, subject to the discussion under “Passive Foreign Investment Company Rules,” above, such dividends will generally be “qualified dividend income” in the hands of individual U.S. Holders, provided that a holding period requirement (more than 60 days of ownership, without protection from the risk of loss, during the 121-day period beginning 60 days before the ex-dividend date) and certain other requirements are met. The dividends will not be eligible for the dividends-received deduction generally allowed to corporate U.S. holders.
However, the qualified dividend income treatment will not apply if we are treated as a PFIC. In addition, the amount of the dividend will be treated as foreign-source dividend income to U.S. Holders and will not be eligible for the dividends-received deduction generally available to U.S. corporations under the Code. Dividends will generally be included in a U.S. Holder’s income on the date of the U.S. Holder’s receipt of the dividend. The amount of any dividend income paid in foreign currency will be the U.S. dollar amount calculated by reference to the exchange rate in effect on the date of actual or constructive receipt, regardless of whether the payment is in fact converted into U.S. dollars. If the dividend is converted into U.S. dollars on the date of receipt, a U.S. Holder should not be required to recognize foreign currency gain or loss in respect of the dividend income. A U.S. Holder may have foreign currency gain or loss if the dividend is converted into U.S. dollars after the date of receipt. Such gain or loss would generally be treated as U.S.-source ordinary income or loss. The amount of any distribution of property other than cash generally will be the fair market value of such property on the date of distribution.
A U.S. Holder generally may claim the amount of any Swiss withholding tax as either a deduction from gross income or a credit against its U.S. federal income tax liability. The foreign tax credit is subject to numerous complex limitations that must be determined and applied on an individual basis. Generally, the credit cannot exceed the proportionate share of a U.S. Holder’s U.S. federal income tax liability that such U.S. Holder’s taxable income bears to such U.S. Holder’s worldwide taxable income. In applying this limitation, a U.S. Holder’s various items of income and deduction must be classified, under complex rules, as either “foreign source” or “U.S. source.” Recently issued U.S. Treasury regulations, which apply to foreign taxes paid or accrued in taxable years beginning on or after December 28, 2021, may in some circumstances prohibit a U.S. Holder from claiming a foreign tax credit with respect to certain foreign taxes that are not creditable under applicable tax treaties. The rules governing foreign tax credits are complex and U.S. Holders should consult their tax advisors regarding the creditability of foreign taxes in their particular circumstances. In addition, the creditability of foreign taxes could be affected by actions taken by intermediaries in the chain of ownership between the holders of our shares or ADSs representing our shares and our company if, as a result of such actions, the holders of our shares or ADSs representing our shares are not properly treated as beneficial owners of the underlying shares. Each U.S. Holder should consult its own tax advisors regarding the foreign tax credit rules.
Sale or Other Taxable Disposition of Shares and ADSs Representing Our Shares
Subject to the discussion above under “Passive Foreign Investment Company Rules,” gain or loss realized on the sale or other taxable disposition of our shares or ADSs representing our shares will be capital gain or loss, and will be long-term capital gain or loss if the U.S. Holder held the shares or ADSs representing our shares for more than one year. The amount of the gain or loss will equal the difference between the U.S. Holder’s adjusted tax basis in the shares or ADSs representing our shares disposed of and the amount realized on the disposition, in each case as determined in U.S. dollars. The adjusted tax basis in our shares or ADSs representing our shares generally will be equal to the cost of such shares or ADSs. This gain or loss will generally be U.S.-source gain or loss for foreign tax credit purposes. The deductibility of capital losses is subject to limitations.
If the consideration received by a U.S. Holder is not paid in U.S. dollars, the amount realized will be the U.S. dollar value of the payment received determined by reference to the spot rate of exchange on the date of the sale or other disposition. However, if the shares or ADSs representing our shares are treated as traded on an “established securities market” and you are either a cash basis taxpayer or an accrual basis taxpayer that has made a special election (which must be applied consistently from year to year and cannot be changed without the consent of the IRS), you will determine the U.S. dollar value of the amount realized in a non-U.S. dollar currency by translating the amount received at the spot rate of exchange on the settlement date of the sale. If you are an accrual basis taxpayer that is not eligible to or does not elect to determine the amount realized using the spot rate on the settlement date, you will recognize foreign currency gain or loss to the extent of any difference between the U.S. dollar amount realized on the date of sale or disposition and the U.S. dollar value of the currency received at the spot rate on the settlement date.
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Information Reporting and Backup Withholding
U.S. Holders generally will be subject to information reporting requirements with respect to dividends on our shares or ADSs representing our shares and on the proceeds from the sale, exchange or disposition of our shares or ADSs representing our shares that are paid within the United States or through certain U.S.-related financial intermediaries, unless the U.S. Holder is an “exempt recipient.” In addition, U.S. Holders may be subject to backup withholding on such payments, unless the U.S. Holder provides a correct taxpayer identification number and a duly executed IRS Form W-9 or otherwise establishes an exemption. Backup withholding is not an additional tax, and the amount of any backup withholding from a payment to a U.S. Holder will be allowed as a credit against a U.S. Holder’s U.S. federal income tax liability and may entitle such holder to a refund, provided that the required information is timely furnished to the IRS.
Certain Reporting Requirements
U.S. Holders paying more than USD100,000 for our shares or ADSs representing our shares generally may be required to file IRS Form 926 reporting the payment of the offer price for our shares or ADSs representing our shares to us. Substantial penalties may be imposed upon a U.S. Holder that fails to comply. Each U.S. Holder should consult its own tax advisor as to the possible obligation to file IRS Form 926.
Information with Respect to Foreign Financial Assets
Certain U.S. Holders who are individuals (and, under regulations, certain entities) may be required to report information relating to our shares or ADSs representing our shares, subject to certain exceptions (including an exception for shares or ADSs representing our shares held in accounts maintained by certain U.S. financial institutions). Such U.S. Holders who fail to timely furnish the required information may be subject to a penalty. Additionally, if a U.S. Holder does not file the required information, the statute of limitations with respect to tax returns of the U.S. Holder to which the information relates may not close until three years after such information is filed. U.S. Holders should consult their tax advisers regarding their reporting obligations with respect to their ownership and disposition of our shares or ADSs representing our shares.
Swiss Tax Considerations
Swiss Federal, Cantonal and Communal Individual Income Tax and Corporate Income Tax
Non-Resident Shareholders
Holders of shares or ADSs representing our shares who are not resident in Switzerland for tax purposes, and who, during the relevant taxation year, have not engaged in a trade or business carried on through a permanent establishment or fixed place of business situated in Switzerland for tax purposes (all such shareholders are hereinafter referred to as the “Non-Resident Shareholders”), will not be subject to any Swiss federal, cantonal and communal income tax on dividends and similar cash or in-kind distributions on ADSs representing our shares (including dividends on liquidation proceeds and stock dividends) (hereinafter referred to as the “Dividends”), distributions based upon a capital reduction or paid out of qualifying reserves from capital contributions recognized by the Swiss Federal Tax Administration on shares underlying the ADSs, or capital gains realized on the sale or other disposition of ADSs (see, however, “Swiss Federal Withholding Tax” below for a summary of Swiss federal withholding tax on Dividends).
Resident Private Shareholders
Swiss resident individuals who hold their ADSs as private assets (all such shareholders are hereinafter referred to as the “Resident Private Shareholders”) are required to include Dividends, but not distributions based upon a capital reduction or paid out of qualifying reserves from capital contributions of the shares underlying the ADSs, in their personal income tax return and are subject to Swiss federal, cantonal and communal income tax on any net taxable income for the relevant taxation period, including the Dividends, but not the distributions based upon a capital reduction or paid out of qualifying reserves from capital contributions. Capital gains resulting from the sale or other dispositions of ADSs are not subject to Swiss federal, cantonal and communal income tax, and conversely, capital losses are not tax-deductible for Resident Private Shareholders. See “Domestic Commercial Shareholders” below for a summary of the taxation treatment applicable to Swiss resident individuals, who, for income tax purposes, are classified as “professional securities dealers”.
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Domestic Commercial Shareholders
Corporate and individual shareholders who are resident in Switzerland for tax purposes or otherwise subject to Swiss taxation and corporate and individual shareholder who are not resident in Switzerland, and who, in each case, hold their ADSs as part of a trade or business carried on in Switzerland, in the case of corporate and individual shareholders not resident in Switzerland, through a permanent establishment or fixed place of business situated, for tax purposes, in Switzerland, are required to recognize Dividends, distributions based upon a capital reduction or paid out of qualifying reserves from capital contributions received on shares underlying the ADSs and capital gains or losses realized on the sale or other disposition of ADSs in their income statement for the relevant taxation period and are subject to Swiss federal, cantonal and communal individual or corporate income tax, as the case may be, on any net taxable earnings for such taxation period. The same taxation treatment also applies to Swiss-resident private individuals who, for income tax purposes, are classified as “professional securities dealers” for reasons of, inter alia, frequent dealing, or leveraged investments in ADSs and other securities (the shareholders referred to in this paragraph), hereinafter for the purposes of this section, as the “Domestic Commercial Shareholders”). Domestic Commercial Shareholders who are corporate tax-payors may be eligible for participation relief in respect of Dividends and distributions based upon a capital reduction or paid out of qualifying reserves from capital contributions if the shares underlying the ADSs held by them as part of a Swiss business have an aggregate market value of at least CHF 1 million.
Swiss Cantonal and Communal Private Wealth Tax and Capital Tax
Non-Resident Shareholders
Non-Resident Shareholders are not subject to Swiss cantonal and communal private wealth tax or capital tax.
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Resident Private Shareholders and Domestic Commercial Shareholders
Resident Private Shareholders and Domestic Commercial Shareholders who are individuals are required to report their ADSs as part of private wealth or their Swiss business assets, as the case may be, and will be subject to Swiss cantonal and communal private wealth tax on any net taxable wealth (including the ADSs), in the case of Domestic Commercial Shareholders to the extent the aggregate taxable wealth is allocated in Switzerland. Domestic Commercial Shareholders who are corporate tax payors are subject to Swiss cantonal and communal capital tax on taxable capital to the extent the aggregate taxable capital is allocated to Switzerland.
Swiss Federal Withholding Tax
Dividends that the Company pays on the shares underlying the ADSs are subject to Swiss Federal withholding tax at a rate of 35% on the gross amount of the Dividend. The Company is required to withhold the Swiss federal withholding tax from the Dividend and remit it to the Swiss Federal Tax Administration. Distributions of the nominal value of the shares underlying the ADSs based upon a capital reduction or paid out of qualifying reserves from capital contributions are not subject to Swiss federal withholding tax.
The Swiss federal withholding tax on a Dividend will be refundable in full to a Resident Private Shareholder and to a Domestic Commercial Shareholder, who, in each case, inter alia, as a condition to refund, duly reports the Dividend in his or her individual income tax return as income or recognizes the Dividends in its income statement as earnings, as applicable.
A Non-Resident Shareholder may be entitled to a partial refund of the Swiss federal withholding tax on Dividend if the country of his or her residence for tax purposes has entered into a bilateral treaty for the avoidance of double taxation with Switzerland and the conditions of such treaty are met. Such shareholders should be aware that the procedures for claiming tax treaty benefits (and the time required for obtaining a refund) might be different from country to country. For example, a shareholder who is resident of the U.S. for the purposes of the bilateral treaty between the U.S. and Switzerland is eligible for a refund of the amount of the withholding tax in excess of the 15% treaty rate, provided such shareholder: (i) qualifies for benefits under this treaty and qualifies as beneficial owner of the Dividends; (ii) hold, directly or indirectly, less than 10% of the voting stock of the Company; (iii) does not qualify as a pension scheme or retirement arrangement for the purpose of the bilateral treaty; and (iv) does not conduct business through a permanent establishment or fixed base in Switzerland to which the ADSs are attributable. Such an eligible U.S. shareholder may apply for a refund of the amount of the withholding tax in excess of the 15% treaty rate. The applicable refund request form may be filed with the Swiss Federal Tax Administration following receipt of the dividend and the relevant deduction certificate, however no later than December 31 of the third year following the calendar year in which the dividend was payable.
Swiss Federal Securities Transfer Tax
Any dealings in the ADSs, where a bank or another securities dealer in Switzerland, as defined in the Swiss Federal Stamp Tax Act, acts as intermediary or is a party to the transaction, are, subject to certain exemptions provided for in the Swiss Federal Stamp Tax Act, subject to Swiss securities transfer tax at an aggregate tax rate of up to 0.15% of the consideration paid for such ADSs.
Swiss Issuance Stamp Duty
The Swiss issuance stamp duty of 1% is levied on the issuance of shares and increases in or contributions to the equity of Swiss tax resident corporations. Exemptions are available in tax neutral restructuring transactions. As a result, the issuance of shares by Company or any other increase in its equity may be subject to the issuance stamp duty unless the equity is increased in the context of a qualifying restructuring transaction.
International Automatic Exchange of Information in Tax Matters
On November 19, 2014, Switzerland signed the Multilateral Competent Authority Agreement, which is based on article 6 of the OECD/Council of Europe administrative assistance convention and is intended to ensure the uniform implementation of automatic exchange of information (the “AEOI”). The Federal Act on the International Automatic Exchange of Information in Tax Matters (the “AEOI Act”) entered into force on January 1, 2017. The AEOI Act is the legal basis for the implementation of the AEOI standard in Switzerland.
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The AEOI bas been introduced in Switzerland through bilateral agreements or multilateral agreements. The agreements have, and will be, concluded on the basis of guaranteed reciprocity, compliance with the principle of specialty (i.e., the information exchanged may only be used to assess and levy taxes (and for criminal tax proceedings)) and adequate data protection.
Based on such multilateral agreements and bilateral agreements and the implementing laws of Switzerland, Switzerland exchanges data in respect of financial assets, including the Shares, held in, and income derived thereon and credited to, accounts or deposits with a paying agent in Switzerland for the benefit of individuals resident in an EU member state or in a treaty state.
Swiss Facilitation of the Implementation of the U.S. Foreign Account Tax Compliance Act
Switzerland has concluded an intergovernmental agreement with the U.S. to facilitate the implementation of FATCA. The agreement ensures that the accounts held by U.S. persons with Swiss financial institutions are disclosed to the U.S. tax authorities either with the consent of the account holder or by means of group requests within the scope of administrative assistance. Information will not be transferred automatically in the absence of consent, and instead will be exchanged only within the scope of administrative assistance on the basis of the double taxation agreement between the U.S. and Switzerland. On October 8, 2014, the Swiss Federal Council approved a mandate for negotiations with the U.S. on changing the current direct-notification-based regime to a regime where the relevant information is sent to the Swiss Federal Tax Administration, which in turn provides the information to the U.S. tax authorities.
F. | Dividends and Paying Agents. |
Not applicable.
G. | Statement by Experts. |
Not applicable.
H. | Documents on Display. |
We are subject to the information reporting requirements of the Exchange Act applicable to foreign private issuers and under those requirements will file reports with the SEC. Those reports may be inspected without charge at the locations described below. As a foreign private issuer, we are exempt from the rules under the Exchange Act related to the furnishing and content of proxy statements, and our officers, directors and principal shareholders are exempt from the reporting and short-swing profit recovery provisions contained in Section 16 of the Exchange Act. In addition, we are not required under the Exchange Act to file periodic reports and financial statements with the SEC as frequently or as promptly as United States companies whose securities are registered under the Exchange Act.
We maintain a corporate website at www.addextherapeutics.com. We intend to post our Annual Report on Form 20-F on our website promptly following it being filed with the SEC. Information contained on, or that can be accessed through, our website does not constitute a part of this Annual Report on Form 20-F. We have included our website address in this Annual Report on Form 20-F solely as an inactive textual reference. The Securities and Exchange Commission maintains a website (www.sec.gov) that contains reports, proxy and information statements and other information regarding registrants, such as Addex, that file electronically with the SEC.
I. | Subsidiary Information. |
Not applicable.
J. | Annual Report to Security Holders. |
Not required.
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Item 11. Quantitative and Qualitative Disclosures About Market Risk.
We operate primarily in Switzerland, Europe and in the United States and are therefore exposed to market risk, which represents the risk of loss that may impact our financial position due to adverse changes in financial market prices and rates. As of December 31, 2024, we had CHF 3.3 million of cash and cash equivalents and we had no debt.
Interest Rate Risk
Our cash is held in readily available checking and money market accounts. As of December 31, 2024, Swiss francs balance represented 81% of the cash and cash equivalents of the company. For the year ended December 31, 2024, we have not paid any effective negative interest rate on Swiss francs cash deposits. As of December 31, 2024, we had no debt and, therefore, no material interest rate risk exposure.
Foreign Currency Exchange Risk
We operate primarily in Switzerland and Europe more broadly and our functional currency is the Swiss franc, and as a result, we are exposed to (1) transactional foreign exchange risk when we or a subsidiary enter into a transaction in a currency other than our or its functional currency and (2) translational foreign exchange risk when we translate financial statements of our foreign subsidiaries from their functional currency into Swiss francs.
Transactional Risk
Our expenses are generally denominated in the currencies of the countries where the relevant transaction takes place, which is primarily in Switzerland, the United States, and to a lesser extent in the Euro-zone countries and United Kingdom. Transactions in foreign currencies of our Swiss company are recorded in Swiss francs at the applicable exchange rate on the date of the relevant transaction. Our results of operations and cash flows are, therefore, subject to fluctuations due to changes in foreign currency exchange rates and may be adversely affected in the future due to changes in foreign currency exchange rates.
Translational Risk
Because our reporting currency is the Swiss franc, or CHF, we may be exposed to translation risk when the income statements of our subsidiaries located in countries outside Switzerland are converted into Swiss francs using the average exchange rate for the period, and whilst revenues and costs are unchanged in local currency, changes in exchange rates may lead to effects on the converted balances of revenue, costs and the result in Swiss francs.
To date, our risk management policy is to economically hedge 100% of anticipated transactions in each major currency for the subsequent 12 months.
Capital Risk
We are not regulated and not subject to specific capital requirements, however, we aim to be compliant with the specific needs of the Swiss law. To ensure that statutory capital requirements are met, we monitor capital periodically on an interim basis as well as annually. From time to time, we may take appropriate measures or propose capital increases at the shareholders’ meeting to ensure the necessary capital remains intact.
Item 12. Description of Securities Other than Equity Securities.
A. | Debt Securities. |
Not applicable.
B. | Warrants and Rights. |
Not applicable.
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C. | Other Securities. |
Not applicable.
D. | American Depositary Shares. |
Citibank, N.A., or Citibank, acts as the depositary for the ADSs representing our shares. Citibank’s depositary offices are located at 388 Greenwich Street, New York, New York 10013. ADSs represent ownership interests in securities that are on deposit with the depositary. ADSs may be represented by certificates that are commonly known as American Depositary Receipts, or ADRs. The depositary typically appoints a custodian to safekeep the securities on deposit. In this case, the custodian is Citibank Zurich, located at 25 Seestrasee, 8021 Zurich, Switzerland.
A deposit agreement among us, the depositary and the ADS holders sets out the ADS holder rights as well as the rights and obligations of the depositary. New York law governs the deposit agreement and the ADSs. A copy of the deposit agreement, as amended, is incorporated by reference as an exhibit to this Annual Report.
Fees and Charges
ADS holders are required to pay the following fees under the terms of the deposit agreement governing the terms of the ADS:
Service |
| Fee |
● Issuance of ADSs (e.g., an issuance of ADS upon a deposit of shares, upon a change in the ADS(s)-to-shares ratio, or for any other reason), excluding ADS issuances as a result of distributions of shares) | ● Up to U.S. 5¢ per ADS issued | |
● Cancellation of ADSs (e.g., a cancellation of ADSs for delivery of deposited property, upon a change in the ADS(s)-to-shares ratio, or for any other reason) | ● Up to U.S. 5¢ per ADS cancelled | |
● Distribution of cash dividends or other cash distributions (e.g., upon a sale of rights and other entitlements) | ● Up to U.S. 5¢ per ADS held | |
● Distribution of ADSs pursuant to (i) stock dividends or other free stock distributions, or (ii) exercise of rights to purchase additional ADSs | ● Up to U.S. 5¢ per ADS held | |
● Distribution of securities other than ADSs or rights to purchase additional ADSs (e.g., upon a spin-off) | ● Up to U.S. 5¢ per ADS held | |
● ADS Services | ● Up to U.S. 5¢ per ADS held on the applicable record date(s) established by the depositary | |
● Registration of ADS transfers (e.g., upon a registration of the transfer of registered ownership of ADSs, upon a transfer of ADSs into DTC and vice versa, or for any other reason) | ● Up to U.S. 5¢ per ADS (or fraction thereof) transferred | |
● Conversion of ADSs of one series for ADSs of another series (e.g., upon conversion of Partial Entitlement ADSs for Full Entitlement ADSs, or upon conversion of Restricted ADSs (each as defined in the Deposit Agreement) into freely transferable ADSs, and vice versa). | ● Up to U.S. 5¢ per ADS (or fraction thereof) converted |
ADS holders are also responsible for paying certain charges such as:
| ● | taxes (including applicable interest and penalties) and other governmental charges; |
| ● | the registration fees as may from time to time be in effect for the registration of shares on the share register and applicable to transfers of shares to or from the name of the custodian, the depositary or any nominees upon the making of deposits and withdrawals, respectively; |
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| ● | certain cable, telex and facsimile transmission and delivery expenses; |
| ● | the fees, expenses, spreads, taxes and other charges of the depositary and/or service providers (which may be a division, branch or affiliate of the depositary) in the conversion of foreign currency; |
| ● | the reasonable and customary out-of-pocket fees and expenses incurred by the depositary in connection with compliance with exchange control regulations and other regulatory requirements applicable to shares, ADSs and ADRs; and |
| ● | the fees, charges, costs and expenses incurred by the depositary, the custodian, or any nominee in connection with the ADR program. |
ADS fees and charges for (i) the issuance of ADSs, and (ii) the cancellation of ADSs are charged to the person for whom the ADSs are issued (in the case of ADS issuances) and to the person for whom ADSs are cancelled (in the case of ADS cancellations). In the case of ADSs issued by the depositary into DTC, the ADS issuance and cancellation fees and charges may be deducted from distributions made through DTC, and may be charged to the DTC participant(s) receiving the ADSs being issued or the DTC participant(s) holding the ADSs being cancelled, as the case may be, on behalf of the beneficial owner(s) and will be charged by the DTC participant(s) to the account of the applicable beneficial owner(s) in accordance with the procedures and practices of the DTC participants as in effect at the time. ADS fees and charges in respect of distributions and the ADS service fee are charged to the holders as of the applicable ADS record date. In the case of distributions of cash, the amount of the applicable ADS fees and charges is deducted from the funds being distributed. In the case of (i) distributions other than cash and (ii) the ADS service fee, holders as of the ADS record date will be invoiced for the amount of the ADS fees and charges and such ADS fees and charges may be deducted from distributions made to holders of ADSs. For ADSs held through DTC, the ADS fees and charges for distributions other than cash and the ADS service fee may be deducted from distributions made through DTC, and may be charged to the DTC participants in accordance with the procedures and practices prescribed by DTC and the DTC participants in turn charge the amount of such ADS fees and charges to the beneficial owners for whom they hold ADSs. In the case of (i) registration of ADS transfers, the ADS transfer fee will be payable by the ADS Holder whose ADSs are being transferred or by the person to whom the ADSs are transferred, and (ii) conversion of ADSs of one series for ADSs of another series, the ADS conversion fee will be payable by the Holder whose ADSs are converted or by the person to whom the converted ADSs are delivered.
In the event of refusal to pay the depositary fees, the depositary may, under the terms of the deposit agreement, refuse the requested service until payment is received or may set off the amount of the depositary fees from any distribution to be made to the ADS holder.
Note that the fees and charges that ADS holders may be required to pay may vary over time and may be changed by us and by the depositary. ADS holders will receive prior notice of such changes. The depositary may reimburse us for certain expenses incurred by us in respect of the ADR program, by making available a portion of the ADS fees charged in respect of the ADR program or otherwise, upon such terms and conditions as we and the depositary agree from time to time.
Taxes
You will be responsible for the taxes and other governmental charges payable on the ADSs and the securities represented by the ADSs. We, the depositary and the custodian may deduct from any distribution the taxes and governmental charges payable by holders and may sell any and all property on deposit to pay the taxes and governmental charges payable by holders. You will be liable for any deficiency if the sale proceeds do not cover the taxes that are due.
The depositary may refuse to issue ADSs, to deliver, transfer, split and combine ADRs or to release securities on deposit until all taxes and charges are paid by the applicable holder. The depositary and the custodian may take reasonable administrative actions to obtain tax refunds and reduced tax withholding for any distributions on your behalf. However, you may be required to provide to the depositary and to the custodian proof of taxpayer status and residence and such other information as the depositary and the custodian may require to fulfill legal obligations. You are required to indemnify us, the depositary and the custodian for any claims with respect to taxes based on any tax benefit obtained for you.
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PART II
Item 13. Defaults, Dividend Arrearages and Delinquencies.
Not applicable.
Item 14. Material Modifications to the Rights of Security Holders and Use of Proceeds.
Not applicable.
Item 15. Disclosure Controls and Procedures.
Our Chief Executive Officer (principal executive officer) and Head of Finance (principal financial officer), after evaluating the effectiveness of our disclosure controls and procedures (as defined in Rule 13a-15(e) of the Exchange Act) as of December 31, 2024, have concluded that, as of such date, our disclosure controls and procedures were not effective due to two material weaknesses identified during the preparation of the consolidated financial statements and described below. Nevertheless, management believes that the consolidated financial statements and related financial information included in this Annual Report on Form 20-F fairly present in all material respects our financial condition, results of operations and cash flows as in conformity with IFRS Accounting Standards.
Management’s Annual Report on Internal Control over Financial Reporting
Our management is responsible for establishing and maintaining adequate internal controls over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) and for the assessment of the effectiveness of our internal control over financial reporting. Under the supervision and with the participation of our Chief Executive Officer (principal executive officer) and Head of Finance (principal financial officer), management assessed our internal control over financial reporting based upon the framework in Internal Control—Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO). Based on this assessment, our management has concluded that our internal control over financial reporting was not effective as of December 31, 2024 due to two material weaknesses identified during the preparation of our consolidated financial statements that were not initially fully compliant with IFRS Accounting Standards. The summarized financial information related to Neurosterix Group as required by IFRS Accounting Standards for material investments in associates was omitted and the consolidated financial statements provided by Neurosterix Group for the calculation of the share of the net loss of investments accounted for using the equity method were not fully compliant with IFRS Accounting Standards. The Management took measures in order to cure the deficiencies in internal control identified during the preparation of our consolidated financial statements.
Attestation Report of the Registered Public Accounting Firm
This Annual Report does not include an attestation report of our registered public accounting firm. For as long as we are an “emerging growth company” under the JOBS Act, our independent registered public accounting firm will not be required to attest to the effectiveness of our internal controls over financial reporting pursuant to Section 404.
Changes in Internal Control Over Financial Reporting
There has been no change in our internal control over financial reporting (as defined in Rule 13a-15(f) under the Exchange Act) that occurred during the period covered by this Annual Report that has materially affected, or is reasonably likely to materially affect, internal control over financial reporting.
Item 16. [Reserved]
Item 16A. Audit Committee Financial Expert.
Our board of directors has determined that Jake Nunn is an “audit committee financial expert” as defined by SEC rules and has the requisite financial sophistication under the applicable rules and regulations of the Nasdaq Stock Market. Mr Nunn is independent as such term is defined in Rule 10A-3 under the Exchange Act and under the listing standards of the Nasdaq Stock Market.
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Item 16B. Code of Business Conduct and Ethics.
We have adopted a Code of Business Conduct and Ethics, or the Code of Conduct, that is applicable to all of our employees, executive officers and directors. A copy of the Code of Conduct is available on our website at www.addextherapeuticscom. Information contained on, or that can be accessed through, our website does not constitute a part of this report and is not incorporated by reference herein. If we make any amendment to the Code of Ethics or grant any waivers, including any implicit waiver, from a provision of the Code of Ethics, we will disclose the nature of such amendment or waiver on our website to the extent required by the rules and regulations of the SEC. Under Item 16B of Form 20-F, if a waiver or amendment of the Code of Ethics applies to our principal executive officer, principal financial officer, principal accounting officer or controller and relates to standards promoting any of the values described in Item 16B(b) of Form 20-F, we are required to disclose such waiver or amendment on our website in accordance with the requirements of Instruction 4 to such Item 16B.
Item 16C. Principal Accountant Fees and Services.
BDO AG has served as our independent registered public accounting firm for the 2024 and 2023 fiscal years. Our accountants billed the following fees to us for professional services in each of those fiscal years:
For the years | ||||
ended | ||||
December 31, | ||||
| 2024 |
| 2023 | |
| (CHF in thousands) | |||
Audit Fees |
| 309 |
| 275 |
Audit‑Related Fees |
| 38 |
| 47 |
Tax Fees |
| — |
| — |
Other Fees |
| — |
| — |
Total |
| 347 |
| 322 |
“Audit Fees” consist of fees billed for the annual audit of our consolidated financial statements, and the statutory audit of our consolidated and stand-alone financial statements. Audit Fees also include services that only our independent external auditor can reasonably provide, such as the review of documents filed with the U.S. stock exchange.
“Audit-Related Fees” consist of fees billed for assurance and related services that are reasonably related to the performance of the audit or review of its financial statements or that are traditionally performed by the external auditor, and mainly include services such as comfort letters issued in connection with securities offerings, due diligence and agreed-upon or expanded audit procedures.
“Tax Fees” consist of tax consultations, such as advice in connection with employees’ taxation arising from share-based compensation.
“Other Fees” consist of advisory services relating to the adoption or application of IFRS Accounting Standards.
Audit and Non-Audit Services Pre-Approval Policy
To ensure the independence and objectivity of our external auditors, the provision of all non-audit services by the external auditors are pre- approved by our audit committee.
Item 16D. Exemptions from the Listing Standards for Audit Committees.
Not applicable.
Item 16E. Purchases of Equity Securities by the Issuer and Affiliated Purchasers.
Not applicable.
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Item 16F. Change in Registrant’s Certifying Accountant.
Not applicable
Item 16G. Corporate Governance.
Summary of Significant Corporate Governance Differences from Nasdaq Listing Standards
As a “foreign private issuer,” as defined by the SEC, we are permitted to follow home country corporate governance practices, instead of certain corporate governance practices required by Nasdaq for U.S. domestic issuers. While we follow most Nasdaq corporate governance rules, we follow Swiss corporate governance practices in lieu of Nasdaq corporate governance rules as follows:
| ● | We do not comply with Nasdaq Rule 5605(b)(1), which would require that our board of directors be comprised of a majority of independent directors. Such requirements are not required under the laws of Switzerland. However, we do make an assessment of the independence of our directors under Swiss corporate governance practices and have concluded that the majority of our directors are independent based upon those standards. |
| ● | We do not follow Nasdaq Rule 5605(d)(1) regarding the compensation committee charter or Nasdaq Rule 5605(d)(2) regarding compensation committee composition. Such requirements are not required under the laws of Switzerland. However, we do maintain a remuneration committee in line with Swiss law. |
| ● | We do not follow Nasdaq Rule 5605(e)(1)(A) with respect to having director nominees selected by independent directors constituting a majority of our board’s independent directors in a vote in which only independent directors participate or Nasdaq Rule 5605(e)(2) regarding the adoption of a formal written charter or board resolution, as applicable, addressing the nominations process. Such requirements are not required under the laws of Switzerland. |
| ● | We do not follow Nasdaq Rule 5620(c) regarding quorum requirements applicable to meetings of shareholders. Such quorum requirements are not required under the laws of Switzerland. |
We must comply with Nasdaq Rule 5640 Notification of Noncompliance and Rule 5640 Voting Rights. Further, we must have an audit committee that satisfies Rule 5605(c)(3), which addresses audit committee responsibilities and authority, and that consists of committee members that meet the independence requirements of Rule 5605(c)(2)(A)(ii), subject to a transition period for newly public companies.
Because we are a foreign private issuer, our directors and senior management are not subject to short-swing profit and insider trading reporting obligations under Section 16 of the Exchange Act. They and our other shareholders are, however, subject to the obligations to report changes in share ownership under Section 13 of the Exchange Act and related SEC Rules.
Item 16H. Mine Safety Disclosure.
Not applicable.
Item 16I. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections.
Not applicable.
Item 16J. Insider Trading policies
Our board of directors has
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Item 16K. Cybersecurity
Risk Management and Strategy
Safeguarding the Company’s information systems, assets, data, intellectual property and network infrastructure and ensuring that risks related to cybersecurity threats are appropriately managed is essential to maintaining a consistently high level of confidentiality, integrity and availability of our information systems; and the trust of our stakeholders, as well as meeting applicable regulatory requirements. We have implemented a multi-faceted cybersecurity risk management framework, which is
Our cybersecurity team is tasked with assessing, identifying and managing risks related to cybersecurity threats and, is responsible for:
| ● | proactive detection and assessment of threats and vulnerabilities through vulnerability testing, penetration testing and attack simulation; |
| ● | development of risk-based action plans to manage identified vulnerabilities and implementation of new protocols and infrastructure improvements; |
| ● | cybersecurity incident investigations, with the assistance of |
| ● | monitoring threats to sensitive data and unauthorized access to Company systems, with assistance of third-party data loss prevention software and a third-party security operations center; |
| ● | developing and executing protocols to ensure that information regarding cybersecurity incidents is promptly shared with our chief information officer, executive leadership team, Audit Committee and Board, as appropriate, to allow for risk and materiality assessments and to consider disclosure and notice requirements; |
| ● | developing and implementing periodic training on cybersecurity, information security and threat awareness; and |
| ● | collaborating with law enforcement and other companies on cybersecurity incidents and best practices. |
We also use third - party service providers to perform a variety of functions throughout our business such as hosting companies and contract research organizations.
For a description of the risks from cybersecurity threats that may materially affect us and how they may do so, see our risk factors under Item 3.D “Risk Factors” in this Annual Report on Form 20 - F.
Role of Management
Our
Role of the Board of Directors
Our Board recognizes the importance of robust cybersecurity management programs and is actively engaged in overseeing and reviewing the Company’s cybersecurity risk profile and exposures.
The responsibilities of the Board include reviewing the cybersecurity threat landscape facing the Company, as well as our strategy, policies and procedures to mitigate cybersecurity risks and any significant cybersecurity incidents. The Board also considers the impact of emerging cybersecurity developments and regulations that may affect the Company.
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PART III
Item 17. Financial Statements.
See pages F-1 through F-69 of this Annual Report on Form 20-F.
Item 18. Financial Statements.
Not applicable.
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Item 19. Exhibits.
List of exhibits:
Incorporated by Reference | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
Exhibit |
| Description |
| Schedule/ |
| File |
| Section/ |
| File Date |
1.1 | Articles of Association of Addex Therapeutics as of June 28, 2024 | |||||||||
1.2 | F-1 | 333-235554 | 3.2 | Dec. 17, 2019 | ||||||
2.1 | F-6 POS | 333-235561 | (a)(i) / (a) (ii) | Oct. 6, 2023 | ||||||
2.2 | Form of American Depositary Receipt (included in Exhibit 2.1) | |||||||||
2.3 | Form of Warrant issued by the Registrant to certain investors on March 28, 2018 | F-1 | 333-235554 | 4.3 | Dec. 17, 2019 | |||||
2.4 | ||||||||||
2.5 | Description of American Depositary Shares representing Ordinary Shares of the Registrant | 424B3 | 333-271611 | “Description of | October 23, 2023 | |||||
2.6 | Form of warrants issued by the registrant to certain investors on December 16, 2021 | F-1 | 333-262050 | “The offering” | Jan. 07, 2022 | |||||
2.7 | Form of warrants issued by the registrant to certain investors on July 22, 2022 | F-1 | 333-266995 | “The offering” | Aug. 19, 2022 | |||||
2.8 | F-1/A | 333-271611 | “The offering” | June 1, 2023 | ||||||
4.1# | F-1 | 333-235554 | 10.1 | Dec. 17, 2019 | ||||||
4.2# | License Agreement between Indivior UK Limited and the Registrant, dated January 2, 2018 | F-1 | 333-235554 | 10.2 | Dec. 17, 2019 | |||||
4.4 | S-8 | 333-255124 | 10.4 | Apr. 8, 2021 | ||||||
4.5 | Addex Therapeutics Ltd Share Option Plan, as amended on July 22, 2022 | 20-F | 001-39179 | 4.5 | March 30, 2023 | |||||
4.6 | Addex Therapeutics Ltd Equity Sharing Certificate Plan, as amended | F-1 | 333-235554 | 10.5 | Dec. 17, 2019 | |||||
4.7# | F-1 | 333-235554 | 10.6 | Dec. 14, 2020 | ||||||
4.8# | Sale Agency Agreement between Addex Therapeutics Ltd and Kepler Cheuvreux | 20-F | 001-39179 | 4.7 | Mar. 11, 2021 | |||||
4.10# | 20-F | 001-39179 | 4.10 | March 30, 2023 | ||||||
4.13# | F-1 | 333-266995 | 10.13 | Aug. 19, 2022 | ||||||
4.14# | 20-F | 001-39179 | 4.14 | March 30, 2023 | ||||||
4.16# | F-1 | 333-266995 | 10.7 | Aug. 19, 2022 | ||||||
4.17# | POSAM | 333-271611 | 10.19 | Aug. 10, 2023 | ||||||
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Incorporated by Reference | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
Exhibit |
| Description |
| Schedule/ |
| File |
| Section/ |
| File Date |
4.19# | POSAM | 333-271611 | 10.20 | Aug. 10, 2023 | ||||||
4.20# | 6-K | 001-39179 | 1.1 | Jan. 30, 2024 | ||||||
4.21# | Service Agreement between Neurosterix Pharma Sàrl and Addex Pharma SA | 20-F | 001-39179 | 4.21 | April 18, 2024 | |||||
4.22# | ||||||||||
8.1 | 20-F | 001-39179 | 8.1 | April 18, 2024 | ||||||
11.1 | ||||||||||
12.1 | ||||||||||
12.2 | ||||||||||
13.1 | ||||||||||
13.2 | ||||||||||
15.1 | ||||||||||
97.1 | 20-F | 001-39179 | 97.1 | April 18, 2024 | ||||||
101.INS | XBRL Instance Document | |||||||||
101.SCH | XBRL Taxonomy Extension Schema Document | |||||||||
101.CAL | XBRL Taxonomy Extension Calculation Linkbase Document | |||||||||
101.LAB | XBRL Taxonomy Extension Label Linkbase Document | |||||||||
101.PRE | XBRL Taxonomy Extension Presentation Linkbase Document | |||||||||
101.DEF | XBRL Taxonomy Extension Definition Linkbase Document | |||||||||
104 | Cover Page interactive data file (formatted as inline XBRL) and contained in Exhibit 101) | |||||||||
†Indicates a management contract or any compensatory plan, contract or arrangement.
#Confidential treatment has been granted from the Securities and Exchange Commission as to certain portions of this document.
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SIGNATURES
The Registrant hereby certifies that it meets all of the requirements for filing on Form 20-F and that it has duly caused and authorized the undersigned to sign this Annual Report on its behalf.
Addex Therapeutics Ltd. | |||
/s/ TIM DYER | /s/ LÉNAIC TEYSSÉDOU | ||
Name: | Tim Dyer | Name: | Lénaic Teyssédou |
Title: | Chief Executive Officer | Title: | Head of Finance |
Switzerland
Dated: May 15, 2025
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INDEX TO FINANCIAL STATEMENTS
Audited Consolidated Financial Statements – Addex Therapeutics
As of December 31, 2024 and 2023 and for the years ended December 31, 2024, 2023 and 2022
Pursuant to Rule 3-09 of Regulation S-X, which requires the inclusion of separate audited financial statements for significant investments that are accounted for under the equity method, the audited consolidated financial statements comprise also the separate audited consolidated financial statements for the associate company Neurosterix US Holdings LLC.
Audited Consolidated Financial Statements – Neurosterix US Holdings LLC
As of December 31, 2024 and for the period from April 2 to December 31, 2024
Consolidated Financial Statements | |
Report of Independent Registered Public Accounting Firm (Zurich, Switzerland; PCAOB ID#5988) | F-46 |
F-49 | |
F-50 | |
Consolidated Statement of Members' Equity for the period from April 2, 2024 to December 31, 2024 | F-51 |
Consolidated Statements of Cash Flows for the period from April 2, 2024 to December 31, 2024 | F-52 |
F-53 |
F-1
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
(BDO AG; Zurich, Switzerland; PCAOB ID#5988)
Shareholders and Board of Directors
Addex Therapeutics Ltd
Geneva, Switzerland
Opinion on the Consolidated Financial Statements
We have audited the accompanying consolidated balance sheets of Addex Therapeutics Ltd (the “Company”) as of December 31, 2024 and 2023, the related consolidated statements of profit or loss, comprehensive profit or loss, changes in equity, and cash flows for each of the three years in the period ended December 31, 2024, and the related notes (collectively referred to as the “consolidated financial statements”). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company at December 31, 2024 and 2023, and the results of its operations and its cash flows for each of the three years in the period ended December 31, 2024, in conformity with IFRS Accounting Standards as issued by the International Accounting Standards Board (IFRS Accounting Standards).
Basis for Opinion
These consolidated financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s consolidated financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.
Our audits included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the consolidated financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements. We believe that our audits provide a reasonable basis for our opinion.
/s/ Christoph Tschumi | /s/ Nigel Le Masurier |
We have served as the Company’s auditor since 2020.
Zurich, Switzerland, May 15, 2025
F-2
F-3
Consolidated Balance Sheets
December 31, | December 31, | |||||
| Notes |
| 2024 |
| 2023 | |
Amounts in Swiss francs | ||||||
ASSETS |
| |||||
Current assets |
|
|
|
|
|
|
Cash and cash equivalents |
| 6 |
| |
| |
Other financial assets |
| 7 |
| |
| |
Trade and other receivables | 7 | | | |||
Contract asset | 7 | — | | |||
Prepayments |
| 7 |
| |
| |
Other current assets | 7 | | — | |||
Total current assets |
|
| |
| | |
Non-current assets |
|
|
|
| ||
Right-of-use assets | 8 | | | |||
Property, plant and equipment |
| 9 |
| |
| |
Non-current financial assets |
| 11 |
| |
| |
Investment accounted for using the equity method | 24 | | — | |||
Total non-current assets |
|
| |
| | |
Total assets |
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| |
| | |
LIABILITIES AND EQUITY |
|
|
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| ||
Current liabilities |
|
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|
| ||
Current lease liabilities | 3.2 | | | |||
Payables and accruals |
| 12 |
| |
| |
Deferred income |
| 13 |
| — |
| |
Total current liabilities |
|
| |
| | |
Non-current liabilities |
|
|
| |||
Non-current lease liabilities | 3.2 | | | |||
Retirement benefits obligations |
| 21 |
| |
| |
Deferred income | 13 | — | | |||
Total non-current liabilities |
|
| |
| | |
Equity |
|
|
| |||
Share capital |
| 14 |
| |
| |
Share premium |
| 14 |
| |
| |
Other equity |
| 14 |
| |
| |
Treasury shares reserve | 14 | ( | ( | |||
Other reserves | | | ||||
Accumulated deficit |
|
|
| ( |
| ( |
Total equity |
|
|
| |
| |
Total liabilities and equity |
|
|
| |
| |
The accompanying notes form an integral part of these consolidated financial statements.
F-4
Consolidated Statements of Profit or Loss
December 31, | December 31, | December 31, | ||||||
| Notes |
| 2024 |
| 2023* |
| 2022* | |
Amounts in Swiss Francs | ||||||||
Revenue from contract with customer | 16 | | | | ||||
Other income | 17 | | | | ||||
Operating costs | ||||||||
Research and development | ( | ( | ( | |||||
General and administration | ( | ( | ( | |||||
Total operating costs | 18 | ( | ( | ( | ||||
Operating loss | ( | ( | ( | |||||
Finance income | | | | |||||
Finance expense | ( | ( | ( | |||||
Finance result | 22 | | ( | ( | ||||
Share of net loss of investments accounted for using the equity method | 24 | ( | — | — | ||||
Net loss before tax from continuing operations | ( | ( | ( | |||||
Income tax expense | 20 | |||||||
Net loss from continuing operations |
|
| ( |
| ( | ( | ||
Net profit / (loss) from discontinued operations (attributable to equity holders of the Group) | 23 | | ( | ( | ||||
Net profit / (loss) for the period | | ( | ( | |||||
Basic and diluted profit / (loss) per share for profit/(loss) attributable to the ordinary equity holders of the Company | 25 | | ( | ( | ||||
From continuing operations | ( | ( | ( | |||||
From discontinued operations | | ( | ( | |||||
*
The accompanying notes form an integral part of these consolidated financial statements.
F-5
Consolidated Statements of Comprehensive Profit or Loss
December 31, | December 31, | December 31, | ||||||
| Notes |
| 2024 |
| 2023* |
| 2022* | |
Amounts in Swiss francs | ||||||||
Net profit / (loss) for the period | | ( | ( | |||||
Other comprehensive income / (loss) | ||||||||
Items that will never be reclassified to profit and loss: | ||||||||
Share of other comprehensive loss of investments accounted for using the equity method | 24 | ( | — | — | ||||
Remeasurements of retirement benefits obligation related to continuing operations |
| 21 |
| ( |
| ( |
| — |
Remeasurements of retirement benefits obligation related to discontinued operations |
| 21 |
| ( |
| ( |
| |
Items that may be classified subsequently to profit and loss: | ||||||||
Exchange difference on translation of foreign operations |
| |
| ( |
| ( | ||
Other comprehensive income / (loss) for the period, net of tax |
| ( |
| ( |
| | ||
Total comprehensive income / (loss) for the year |
| |
| ( |
| ( | ||
From continuing operations |
| ( |
| ( |
| ( | ||
From discontinued operations |
| |
| ( |
| ( | ||
The accompanying notes form an integral part of these consolidated financial statements.
F-6
Consolidated Statements of Changes in Equity (1/3)
|
|
|
| Foreign |
|
|
| |||||||||||
Treasury | Currency | |||||||||||||||||
Share | Share | Shares | Translation | Other | Accumulated | |||||||||||||
| Notes |
| Capital |
| Premium |
| Other equity |
| Reserve |
| Reserve |
| Reserves |
| Deficit |
| Total | |
Balance as of December 31, 2021 |
| |
| | — | ( |
| ( |
| |
| ( |
| | ||||
Net loss for the year |
| — |
| — | — | — |
| — |
| — |
| ( |
| ( | ||||
Other comprehensive income for the year |
| — |
| — | — | — |
| ( |
| |
| — |
| | ||||
Total comprehensive loss for the year |
| — |
| — | — | — |
| ( |
| |
| ( |
| ( | ||||
Reduction of the nominal value | 14 | ( | — | | — | — | — | — | — | |||||||||
Issue of treasury shares | 14 | | — | — | ( | — | — | — | — | |||||||||
Exercise ESOP & ESC (treasury shares IFRS 2) | 14/15 | | — | — | ( | — | — | — | — | |||||||||
Cost of shares issuance | — | ( | — | — | — | — | — | ( | ||||||||||
Sales under shelf registration | 14 | — | ( | — | | — | — | — | | |||||||||
Related costs of sales shelf registration | — | ( | — | — | — | — | — | ( | ||||||||||
Sale of pre-funded warrants | 14 | — | — | — | — | — | | — | | |||||||||
Cost of pre-funded warrants sold | — | — | — | — | — | ( | — | ( | ||||||||||
Exercise of pre-funded warrants | — | ( | — | | — | ( | — | | ||||||||||
Value of warrants and pre-funded warrants | 14 | — | ( | — | — | — | | — | — | |||||||||
Value of share-based services | 15 | — | — | — | — | — | | — | | |||||||||
Movement in treasury shares: | 14 | |||||||||||||||||
Net purchases under liquidity agreement | — | ( | — | | — | — | — | ( | ||||||||||
Sales agency agreement | — | ( | — | | — | — | — | | ||||||||||
Costs under sale agency agreement | — | ( | — | — | — | — | — | ( | ||||||||||
Balance as of December 31, 2022 | | | | ( | ( | | ( | |
The accompanying notes form an integral part of these consolidated financial statements.
F-7
Consolidated Statements of Changes in Equity (2/3)
|
|
|
|
|
| Foreign |
|
|
| |||||||||
Treasury | Currency | |||||||||||||||||
Share | Share | Shares | Translation | Other | Accumulated | |||||||||||||
Notes | Capital | Premium | Other equity | Reserve | Reserve | Reserves | Deficit | Total | ||||||||||
Balance as of December 31, 2022 | | | | ( | ( | | ( | | ||||||||||
Net loss for the year | — | — | — | — | — | — | ( | ( | ||||||||||
Other comprehensive loss for the year | — | — | — | — | ( | ( | — | ( | ||||||||||
Total comprehensive loss for the year | — | — | — | — | ( | ( | ( | ( | ||||||||||
Issue of treasury shares |
| 14 |
| |
| — |
| — |
| ( |
| — |
| — |
| — |
| — |
Exercise ESOP (treasury shares IFRS 2) |
| 14/15 | |
| — |
| — |
| ( |
| — |
| — |
| — |
| — | |
Cost of treasury shares issuance |
| — |
| ( |
| — |
| — |
| — |
| — |
| — |
| ( | ||
Sales under shelf registration |
| 14 |
| — |
| ( |
| — |
| |
| — |
| — |
| — |
| |
Related costs of sales shelf registration |
| — |
| ( |
| — |
| — |
| — |
| — |
| — |
| ( | ||
Sale of pre-funded warrants |
| 14 |
| — |
| — |
| — |
| — |
| — |
| |
| — |
| |
Cost of pre-funded warrants sold |
|
| — |
| — |
| — |
| — |
| — |
| ( |
| — |
| ( | |
Exercise of pre-funded warrants |
|
| |
| |
| — |
| — |
| — |
| ( |
| — |
| | |
Costs of pre - funded warrants exercised | — | ( | — | — | — | — | — | ( | ||||||||||
Value of warrants and pre-funded warrants |
| 14 |
| — |
| ( |
| — |
| — |
| — |
| |
| — |
| — |
Value of share-based services |
| 15 |
| — |
| — |
| — |
| — |
| — |
| |
| — |
| |
Movement in treasury shares: |
| 14 |
| |||||||||||||||
Net purchases under liquidity agreement |
|
| — |
| ( |
| — |
| ( |
| — |
| — |
| — |
| ( | |
Sales agency agreement |
| 14 |
| — |
| ( |
| — |
| |
| — |
| — |
| — |
| |
Costs under sale agency agreement |
|
| — |
| ( |
| — |
| — |
| — |
| — |
| — |
| ( | |
Balance as of December 31, 2023 |
|
| |
| |
| |
| ( |
| ( |
| |
| ( |
| |
The accompanying notes form an integral part of these consolidated financial statements.
F-8
Consolidated Statements of Changes in Equity (3/3)
|
|
|
|
|
| Foreign |
|
|
| |||||||||
Treasury | Currency | |||||||||||||||||
Share | Share | Shares | Translation | Other | Accumulated | |||||||||||||
| Notes |
| Capital |
| Premium |
| Other equity |
| Reserve |
| Reserve |
| Reserves |
| Deficit |
| Total | |
Balance as of December 31, 2023 | | | | ( | ( | | ( | | ||||||||||
Net profit for the year |
|
| — |
| — |
| — |
| — |
| — |
| — |
| |
| | |
Other comprehensive loss for the year |
|
| — |
| — |
| — |
| — |
| |
| ( |
| — |
| ( | |
Total comprehensive loss for the year |
|
| — |
| — |
| — |
| — |
| |
| ( |
| |
| | |
Cost of treasury shares issuance |
|
| — |
| ( |
| — |
| — |
| — |
| — |
| — |
| ( | |
Cost of pre - funded warrants exercised | — | ( | — | — | — | — | — | ( | ||||||||||
Value of share-based services |
| 15 |
| — |
| — |
| — |
| — |
| — |
| |
| — |
| |
Movement in treasury shares: |
| 14 |
|
|
|
|
|
|
|
| ||||||||
Net sales under liquidity agreement |
|
| — |
| ( |
| — |
| |
| — |
| — |
| — |
| | |
Sales agency agreement |
| 14 |
| — |
| |
| — |
| |
| — |
| — |
| — |
| |
Costs under sale agency agreement |
|
| — |
| ( |
| — |
| — |
| — |
| — |
| — |
| ( | |
Balance as of December 31, 2024 |
|
| |
| |
| |
| ( |
| ( |
| |
| ( |
| |
The accompanying notes form an integral part of these consolidated financial statements.
F-9
Consolidated Statements of Cash Flows
December 31, | December 31, | December 31, | ||||||
| Notes |
| 2024 |
| 2023 |
| 2022 | |
Amounts in Swiss francs | ||||||||
Net profit / (loss) for the period |
|
|
| |
| ( | ( | |
Adjustments for: |
|
|
|
| ||||
Net gain on Neurosterix Transaction | 23 | ( | — | — | ||||
Value of share-based services | 15/23 | | | | ||||
Post-employments benefits | 21/23 | ( | ( | ( | ||||
Share of net loss of associates | 24 | | — | — | ||||
Depreciation |
| 8/23 |
| |
| | | |
Net gain related to lease modification | ( | ( | — | |||||
Net finance cost / (gain) |
|
|
| ( |
| | | |
Decrease / (increase) in other financial assets |
| 7/23 |
| ( |
| | | |
Increase in trade and other receivables |
| 7/23 |
| |
| | ( | |
Decrease/ (increase) in contract asset |
| 7/23 |
| |
| | ( | |
Decrease / (increase) in prepayments |
| 7/23 |
| ( |
| | | |
Increase in other current assets |
| 7/23 |
| ( |
| — | — | |
Decrease in payables and accruals |
| 12/23 |
| ( |
| ( | ( | |
Increase / (decrease) in deferred income |
|
| ( |
| | — | ||
Net cash used in operating activities |
|
|
| ( |
| ( | ( | |
Cash flows from investing activities |
|
|
|
| ||||
Cash received from Neurosterix Transaction | 23 | | — | — | ||||
Legal fees paid for Neurosterix Transaction | 23 | ( | — | — | ||||
Purchase of property, plant and equipment |
| 9 |
| ( |
| ( | ( | |
Proceeds from decrease in non-current financial assets |
|
| — |
| — | | ||
Net cash from/(used in) investing activities |
|
|
| |
| ( | | |
Cash flows from financing activities |
|
|
|
| ||||
Proceeds from sale of treasury shares-shelf registration |
| 14 |
| — |
| | | |
Costs paid on sale of treasury shares-shelf registration | ( | ( | ( | |||||
Proceeds from the sale or exercise of pre-funded warrants | 14 | — | | | ||||
Costs paid on sale or exercise of pre-funded warrants | ( | ( | ( | |||||
Sales under sale agency agreement & liquidity agreement movements | 14 | | | | ||||
Costs paid on sale of treasury shares under sale agency agreement | ( | ( | ( | |||||
Cost paid on issue of treasury shares | — | ( | ( | |||||
Principal element of lease payment | ( | ( | ( | |||||
Interest received | 22 | | | | ||||
Interest paid |
| 22 |
| ( |
| ( | ( | |
Net cash from financing activities |
|
|
| |
| | | |
Decrease in cash and cash equivalents |
|
|
| ( |
| ( | ( | |
Cash and cash equivalents at beginning of the year |
| 6 |
| |
| | | |
Exchange difference on cash and cash equivalents |
|
|
| |
| ( | ( | |
Cash and cash equivalents at end of the year |
| 6 |
| |
| | | |
During the twelve-month period ended December 31, 2024, the Group reported a net gain on Neurosterix Transaction of CHF
The accompanying notes form an integral part of these consolidated financial statements.
F-10
Notes to the Consolidated Financial Statements
(Amounts in Swiss francs)
1. General information
Addex Therapeutics Ltd (the “Company”) and its subsidiaries (together, the “Group”) are a clinical stage biopharmaceutical company focused on developing a portfolio of novel small molecule allosteric modulators for neurological disorders.
The Company is a Swiss stockholding corporation domiciled c/o Addex Pharma SA, Chemin des Aulx 12, CH 1228 Plan-les-Ouates, Geneva, Switzerland and the parent company of Addex Pharma SA, Addex Pharmaceuticals France SAS and Addex Pharmaceuticals Inc. Addex Therapeutics also owns a
The Groups principal place of business is Chemin des Mines 9, CH 1202 Geneva, Switzerland. Its registered shares are traded at the SIX Swiss Exchange, under the ticker symbol ADXN and its American Depositary Shares (ADSs) on the Nasdaq Stock Market under the symbol “ADXN”. ADSs represents shares that continue to be admitted to trading on SIX Swiss Exchange.
These consolidated financial statements have been approved for issuance by the Board of Directors on 24 April, 2025.
2. Summary of material accounting policies
The principal accounting policies applied in the preparation of these consolidated financial statements are set out below. These policies have been consistently applied to all the years presented, unless otherwise stated.
2.1 | Basis of preparation |
The consolidated financial statements of Addex Therapeutics Ltd have been prepared in accordance with IFRS Accounting Standards as issued by the International Accounting Standards Board (IFRS Accounting Standards), and under the historical cost convention.
The preparation of financial statements in conformity with IFRS Accounting Standards requires the use of certain critical accounting estimates. It also requires management to exercise its judgment in the process of applying the Group’s accounting policies. The areas involving a higher degree of judgment or complexity, or areas where assumptions and estimates are significant to the consolidated financial statements are disclosed in note 4 “Material accounting estimates and judgements”.
Due to rounding, numbers presented throughout these consolidated financial statements may not add up precisely to the totals provided. All ratios and variances are calculated using the underlying amount rather than the presented rounded amount.
Where necessary, comparative figures have been revised to conform with the current year 2024 presentation. In particular, we re-presented the consolidated statements of profit or loss and comprehensive income or loss for the year ended December 31, 2023, in order to reclass discontinued operations in accordance with IFRS 5 (note 23). In addition, the ADS numbers previously disclosed have been amended following the change in ADS ratio executed on October 23, 2023, from one ADS to
F-11
2.2 | Standards and interpretations published by the IASB |
New and amended standards adopted by the Group
A number of new or amended standards and interpretations became applicable for financial reporting periods beginning on or after January 1, 2024. Of the latter, the Group noted the publication of IFRS S1 (General requirement for disclosure of sustainability-related financial information) and IFRS S2 (climate – related Disclosures). The Group concluded that those new IFRS Accounting Standards were not relevant as the Group did not opt for the publication of a sustainability report in accordance with Six Swiss Exchange listing rules.
There are other new standards, amendments and interpretations which have been deemed by the Group as currently not relevant, hence are not listed or discussed further here.
New standards and interpretations not yet adopted by the Group
The Group is currently assessing the potential impacts of the various new and revised standards and interpretations that will be mandatory from January 1, 2025, which the Group has not yet applied. Based on an analysis to date, the Group does not anticipate that these will have a material impact on the Group’s overall results and financial position. The Group is also assessing other new and revised standards which are not mandatory until after 2025 and noted that IFRS 18 – Presentation and Disclosure in Financial Statements will replace IAS 1 - Presentation of Financial Statements - from January 1, 2027.
2.3 | Consolidation |
Subsidiaries are all entities over which the Group has control. The Group controls an entity when the Group is exposed to, or has rights to, variable returns from its involvement with the entity and has the ability to affect those returns through its power over the entity. Subsidiaries are fully consolidated from the date on which control is transferred to the Group. They are de-consolidated from the date that control ceases.
The Company currently consolidates the financial operations of its
Inter-company transactions, balances and unrealized gains on transactions between Group companies are eliminated. Unrealized losses are also eliminated unless the transaction provides evidence of an impairment of the asset transferred. Accounting policies of subsidiaries have been changed where necessary to ensure consistency with the policies adopted by the Group. The reporting date of all Group companies is December 31.
2.4 | Segment reporting |
The Group operates in
2.5 | Foreign currency transactions |
Functional and presentation currency
Items included in the financial statements of each of the Group’s entities are measured using the currency of the primary economic environment in which the entity operates (“the functional currency”). The consolidated financial statements are presented in Swiss francs, which is the Group’s presentation currency.
F-12
Transactions and balances
Foreign currency transactions are translated into the functional currency using the exchange rates prevailing at the dates of the transactions or valuation where items are re-measured. Foreign exchange gains and losses resulting from the settlement of such transactions and from the translation at year-end exchange rates of monetary assets and liabilities denominated in foreign currencies are recognized in the statement of comprehensive loss.
Foreign exchange gains and losses that relate to borrowings and cash and cash equivalents are presented in the statement of comprehensive loss within ‘finance result’.
Group companies
The results and financial position of the Group’s subsidiary that has a functional currency different from the presentation currency are translated into the presentation currency as follows:
| ● | assets and liabilities for each balance sheet presented are translated at the closing rate at the date of that balance sheet; |
| ● | income and expenses for each statement of comprehensive loss are translated at the average exchange rate; and |
| ● | all resulting exchange differences are recognized in other comprehensive loss. |
2.6 | Property, plant and equipment |
Property, plant and equipment are stated at historical cost less accumulated depreciation, and impairment (if any). Historical cost includes expenditure that is directly attributable to the acquisition of the item. Subsequent costs are included in the asset’s carrying amount or recognized as a separate asset, as appropriate, only when it is probable that future economic benefits associated with the item will flow to the Group and the cost of the item can be measured reliably. All other repairs and maintenance are charged to the statement of comprehensive loss during the financial period in which they are incurred. Depreciation is calculated using the straight-line method to allocate their cost to their residual values over their estimated useful lives as follows:
Computer equipment |
| |
Laboratory equipment |
| |
Furniture and fixtures |
| |
Chemical library |
|
The assets’ residual values and useful lives are reviewed, and adjusted if appropriate, at each balance sheet date. An asset’s carrying amount is written down immediately to its recoverable amount if the asset’s carrying amount is greater than its estimated recoverable amount (see note 2.7). Gains and losses on disposals are determined by comparing proceeds with the carrying amount and are included in the statement of comprehensive loss.
2.7 | Financial assets |
The Group has
Trade and other receivables are initially measured at fair value and subsequently measured at amortized cost and are derecognized when settled.
The Group classifies a contract asset as a receivable when the Group’s right to consideration is unconditional. If the Group transfers control of goods or services to a customer before the customer pays consideration, the Group records either a contract asset or a receivable depending on the nature of the Group’s right to consideration for its performance. Contract assets and contract liabilities arising from the same contract are netted and presented as either a single net contract asset or net contract liability.
F-13
Impairment of financial assets
The Group recognizes a loss allowance for expected credit losses on trade and other receivables, contract assets and security rental deposits that are measured at amortized cost. The amount of expected credit losses is updated at each reporting date to reflect changes in credit risk since initial recognition of the respective financial instrument.
The Group always recognizes lifetime expected credit losses(“ECL”) for trade and other receivables and contract assets where applicable. The ECL on these financial assets are estimated using a provision matrix based on the Group’s historical credit loss experience, adjusted for factors that are specific to the debtors, general economic conditions and an assessment of both the current as well as the forecast direction of conditions at the reporting date, including time value of money where appropriate.
Lifetime ECL represents the ECL that will result from all possible default events over the expected life of a financial instrument. In contrast, 12-month ECL represents the portion of lifetime ECL that is expected to result from default events on a financial instrument that are possible within 12 months after the reporting date.
2.8 | Cash and cash equivalents |
Cash and cash equivalents include cash on hand, deposits held at call with banks and other short-term highly liquid investments with original maturities of three months or less. They are both readily convertible to known amounts of cash and so near their maturity that they present insignificant risk of changes in value because of changes in interest rates. Any bank overdrafts are not netted against cash and cash equivalents but are shown as part of current liabilities on the consolidated balance sheet.
2.9 | Share capital |
Shares are classified as equity. Incremental costs directly attributable to the issue of new shares are shown as a deduction, net of tax, from the proceeds.
Where any Group company purchases the Company’s equity share capital (treasury shares), the consideration paid, including any directly attributable incremental cost (net of income taxes) is recorded as a deduction from equity attributable to the Company’s equity holders as a treasury share reserve until the shares are cancelled, reissued or disposed of. When such shares are subsequently sold or reissued, any consideration received, net of any directly attributable incremental transaction costs and the related income tax effect, the nominal amount is reversed from the treasury share reserve, with any remaining difference to the total transaction value being recognized in share premium.
The Company has entered into a liquidity contract where an independent broker buys and sells the Company’s shares held in the broker’s custody. Such shares are presented in the treasury share reserve with all other treasury shares directly held by Addex Pharma SA.
The Group also uses treasury shares to partially settle services rendered by third and related parties. When shares are issued for this purpose, the nominal share value is recognized as a treasury share reserve and the value above par is presented as a share premium.
2.10 | Equity instruments |
Shares issued by the Group and the sale of pre-funded warrants are both recorded at the fair value of the proceeds received, net of direct issuance costs. The fair value of pre-funded warrants sold is recorded in equity at the grant date. The Group grants from time-to-time warrants to brokers and investors. The fair value of the warrants is recorded in equity at the grant date.
2.11 | Trade payables |
Trade payables are recognized initially at fair value and subsequently measured at amortized cost using the effective interest method. All payables have a contract maturity within 1 year.
F-14
2.12 | Grants |
Grants are not recognized until there is reasonable assurance that the Group will comply with the terms and conditions of the grant and that the grants will be received. Grants are recognized as other income in the statement of comprehensive loss on a systematic basis over the periods in which the Group recognizes as expenses the related costs for which the grant is intended to compensate. Specifically, grants whose primary conditions are that the Group should undertake specific research activities within a defined period of time, are recognized as deferred income in the consolidated statement of financial position and transferred to the statement of comprehensive loss on a systematic and rationale basis over the defined timeframe.
2.13 | Deferred income tax |
Deferred income tax is recorded in full, using the liability method, on temporary differences arising between the tax bases of assets and liabilities and their carrying amounts in the consolidated financial statements. However, if the deferred income tax arises from initial recognition of an asset or liability in a transaction other than a business combination that at the time of the transaction affects neither accounting nor taxable profit or loss, it is not accounted for. Deferred income tax is determined using tax rates and laws that have been enacted or substantively enacted by the balance sheet date and are expected to apply when the related deferred income tax asset is realized, or the deferred income tax liability is settled.
Deferred income tax assets are recognized to the extent that it is probable that future taxable profit will be available against which the temporary differences can be utilized.
Deferred income tax is recorded on temporary differences arising on investments in subsidiaries, except where the Group deems it probable that the temporary difference will not reverse in the foreseeable future. The temporary differences arising in investments accounted for using the equity method are recorded as deferred income taxes.
Potential deferred income tax assets from tax loss carry forwards exceed deferred tax liabilities. Deferred income tax assets from tax loss carry forwards are initially recognized to the extent that the realization of the related tax benefit through future taxable profits is probable.
2.14 | Pension obligations |
The Group operates
Under IAS 19, the shortfall or the surplus of the fair value of the plan assets compared with the defined benefit obligation is recorded as a liability or an asset in the consolidated balance sheet. That recognition is subject to asset ceiling rules and minimum funding requirements set out in IFRIC 14. The defined benefit obligation is calculated at least annually by an independent actuary using the projected unit credit method. The present value of the defined benefit obligation is determined by discounting the estimated future cash outflows using interest rates of high-quality corporate bonds that are denominated in the currency in which the benefits will be paid, and that have terms to maturity approximating to the terms of the related pension liability.
F-15
2.15 | Share-based compensation |
The Group operates an equity sharing certificates’ equity incentive plan, a share option plan, and a share purchase plan. The fair value of the services received in exchange for the grant or transfer of equity sharing certificates, options, shares is recognized in the consolidated financial statements over the period for which the services are received. The total amount to be recognized over the vesting period is determined by reference to the fair value of the equity incentive unit granted or transferred. The fair value of instruments granted includes any market performance conditions and excludes the impact of any service and non-market performance vesting conditions. Service and non-market performance conditions are included in assumptions about the number of equity incentive units that are expected to vest. At each balance sheet date, the Group revises its estimates for the number of equity incentive units that are expected to vest. It recognizes the impact of the revision to original estimates, if any, in the statement of comprehensive loss, with a corresponding adjustment to equity. The proceeds received net of any directly attributable transaction costs are credited to share capital (nominal value) and share premium when the equity incentive units are exercised.
2.16 | Revenue recognition |
The Group recognizes revenue from the license of intellectual property and providing research and development services:
License of intellectual property
If the license to the Group’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Group recognizes revenues when the license conveys a right of use, or there is a right of access to the underlying intellectual property. For licenses that are sold in conjunction with a related service, the Group uses judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time. If the performance obligation is settled over time, the Group determines the appropriate method of measuring progress for purposes of recognizing license revenue. The Group evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition.
Research and development services
The Group has an arrangement with its partner that includes deploying its employees for research and development activities. The Group assesses if these research and development activities are considered distinct in the context of the respective contract and, if so, they are accounted for as a separate performance obligation. This revenue is calculated based on the costs incurred (input method) in accordance with the respective contract and recorded within “Revenue from contract with customer” over time as the activities are performed.
Contract balances
The Group receives payments and determines credit terms from its customers for its various performance obligations based on billing schedules established in each contract. The actual timing of the income recognition, billings and cash collections may result in other current receivables, accrued revenue (contract assets), and deferred revenue (contract liabilities) being recorded on the balance sheet. Amounts are recorded as other current receivables when the Group’s right to consideration is unconditional. The Group does not assess whether a contract has a significant financing component if the expectation at contract inception is such that the period between payment by the customer and the transfer of the promised goods or services to the customer will be one year or less.
Under IFRS 15, the Group mainly recognizes as revenue its non-refundable license fees, milestone, research activities and royalties when its customer obtains control of promised services, in an amount that reflects the consideration which the Group expects to receive in exchange for those rendered services. At contract inception, once the contract is determined to be within the scope of IFRS 15, the Group assesses the services promised within each contract and determine those that are performance obligations and assess whether each promised service is distinct. The Group uses the most likely method to estimate any variable consideration and include such consideration in the amount of the transaction price based on an estimated stand-alone selling price. Revenue is recognized for the respective performance obligation when (or as) the performance obligation is satisfied.
2.17 | Finance income and expense |
Interest received or paid on cash and cash equivalents are classified in the statement of cash flows under financing activities.
F-16
2.18 | Leases |
The Group assesses whether a contract is or contains a lease, at inception of the contract. The Group recognizes a right-of-use asset and a corresponding lease liability with respect to all lease arrangements in which it is the lessee, except for short-term leases (defined as leases with a lease term of 12 months or less) and leases of low value assets (less than CHF 5 thousand). For these leases, the Group recognizes the lease payments as an operating expense on a straight-line basis over the term of the lease unless another systematic basis is more representative of the time pattern in which economic benefits from the leased assets are consumed.
The lease liability is initially measured at the present value of the lease payments as from the commencement date of the lease until the expected termination date. In determining the lease term, management consider all facts and circumstances that create an economic incentive to exercise an extension option, or not to exercise a termination option. Extension option are only considered if the lease is reasonably certain to be extended. The assessment of reasonable certainty is only revised if a significant event or a significant change in circumstances, that is within the control of the lessees, occurs.
The right-of-use assets comprise the initial measurement of the corresponding lease liability, lease payments made at or before the commencement day, less any lease incentives received and any initial direct costs. They are subsequently measured at cost less accumulated depreciation and impairment losses. They are depreciated over the shorter period of lease term and useful life of the underlying asset. If a lease transfers ownership of the underlying asset or the cost of the right-of-use asset reflects that the Group expects to exercise a purchase option, the related right-of-use asset is depreciated over the useful life of the underlying asset. The depreciation starts at the commencement date of the lease. The right-of-use assets are presented as a separate line in the consolidated statement of financial position.
All lease payments on leases are presented as part of the cash flow from financing activities, except for the short-term and low value leases cash flows, which are booked under operating activities.
2.19 | Research and development |
Research and development costs are expensed as incurred. Costs incurred on development projects are recognized as intangible assets when the following criteria are fulfilled:
| ● | it is technically feasible to complete the intangible asset so that it will be available for use or sale; |
| ● | management intends to complete the intangible asset and use or sell it; |
| ● | there is an ability to use or sell the intangible asset; |
| ● | it can be demonstrated how the intangible asset will generate probable future economic benefits; |
| ● | adequate technical, financial and other resources to complete the development and to use or sell the intangible asset are available; and |
| ● | the expenditure attributable to the intangible asset during its development can be reliably measured. |
In the opinion of management, due to uncertainties inherent in the development of the Group’s products, the criteria for development costs to be recognized as an asset, as prescribed by IAS 38, “Intangible Assets”, are not met.
3. Financial risk management
3.1 | Financial risk factors |
The Group’s activities expose it to a variety of financial risks: market risk, credit risk, liquidity risk and capital risk. The Group’s overall risk management program focuses on the unpredictability of financial markets and seeks to minimize potential adverse effects on the Group’s financial performance. Risk management is carried out by the Group’s finance department (Group Finance) under the policies approved by the Board. Group Finance identifies, evaluates and in some instances economically hedges financial risks in close co-operation with the Group’s operating units. The Board provides written guidance for overall risk management, as well as written policies covering specific areas, such as foreign exchange risk, interest-rate risk, use of derivative financial instruments and non-derivative financial instruments, credit risk and investing excess liquidity.
F-17
Market risk and foreign exchange risk
The Group operates internationally and is exposed to foreign exchange risk arising from various exposures with respect to the Euro, US dollar and UK pound. Foreign exchange risk arises from future commercial transactions, recognized assets and liabilities and net investments in foreign operations. To manage foreign exchange risk Group Finance maintains foreign currency cash balances to cover anticipated future requirements. The Group’s risk management policy is to economically hedge
Interest rate risk
The Group’s exposure to interest rate fluctuations is limited because the Group has
Credit risk
Credit risk is managed on a Group basis. Credit risk arises from cash and cash equivalents and deposits with banks, as well as credit exposures to collaboration partners. The Group has a limited number of collaboration partners and consequently has a significant concentration of credit risk. The Group has policies in place to ensure that credit exposure is kept to a minimum and significant concentrations of credit risk are only granted for short periods of time to high credit quality partners. The Group’s policy is to invest funds in low-risk investments including interest bearing deposits. For banks and financial institutions, only independently rated parties with a minimum rating of “A” are accepted (see note 6).
Liquidity risk
The Group’s principal source of liquidity is its cash reserves which are obtained through the sale of new shares and to a lesser extent the sale of its research and development stage products. Group Finance monitors rolling forecasts of the Group’s liquidity requirements to ensure it has sufficient cash to meet operational needs. The ability of the Group to maintain adequate cash reserves to sustain its activities is highly dependent on the Group’s ability to raise further funds from the licensing of its development stage products and the sale of new shares. Consequently, the Group is exposed to significant liquidity risk (see note 4).
3.2 | Capital risk management |
The Group is not regulated and not subject to specific capital requirements. The amount of equity depends on the Group’s funding needs and statutory capital requirements. The Group monitors capital periodically on an interim and annual basis. From time to time, the Group may take appropriate measures or propose capital increases to its shareholders to ensure the necessary capital remains intact. The Group did
The ability of the Group to maintain adequate cash reserves to continue its activities is subject to risk as it is highly dependent on the Group’s ability to raise further funds from the sale of new shares.
The Group’s objectives when managing capital based on its net debt are to safeguard the Group’s ability to continue as a going concern in order to ensure the financing of successful research and development activities so that future profits can be generated and to maintain sufficient financial resources to mitigate against risks and unforeseen events.
F-18
A reconciliation of the net debt position is detailed as follows:
|
| Cash and |
| Other |
| |||
cash | financial |
| ||||||
| Leases |
| equivalents |
| assets |
| Total | |
Net asset / (debt) as at January 1, 2023 |
| ( | | | | |||
Cash flows |
| | ( | ( | ( | |||
Effect of modification to lease terms |
| ( | — | — | ( | |||
Foreign exchange differences | — | ( | — | ( | ||||
Net asset / (debt) as at December 31, 2023 |
| ( | | | | |||
Cash flows |
| | ( | | ( | |||
Effect of modification to lease terms | ( | — | — | ( | ||||
Disposal | | — | — | | ||||
Assets transferred to Neurosterix Pharma Sàrl | | — | — | | ||||
Foreign exchange differences |
| — | | — | | |||
Net asset / (debt) as at December 31, 2024 |
| ( | | | |
In addition, the maturity profile of the Group’s financial liabilities is presented in the table below:
|
|
| More |
| Total |
| Carrying | |||
Less than | 1 to 5 | than | cash out | amount | ||||||
At December 31, 2024 | 1 Year | Years | 5 Years | flows | liabilities | |||||
Lease Liabilities |
| | | — | | | ||||
|
|
| More |
| Total |
| Carrying | |||
Less than | 1 to 5 | than | cash out | amount | ||||||
At December 31, 2023 | 1 Year | Years | 5 Years | flows | liabilities | |||||
Lease Liabilities |
| | | — | | |
As of December 31, 2023, lease liabilities relate to the rent of laboratories, equipment, offices and related spaces used by the Group. Following the Neurosterix transaction executed on April 2, 2024 (note 23), the Group reduced the number of leases.
3.3 | Fair value estimation |
The nominal value less estimated credit adjustments of trade and other receivables, contract assets and payables are assumed to approximate to their fair values due to the short-term maturity of these instruments and are held at their amortized cost in accordance with IFRS 9. The fair value of other financial assets and liabilities for disclosure purposes is estimated by discounting the future contractual cash flows at the current market interest rate that is available to the Group for similar financial instruments.
F-19
4.Material accounting estimates and judgments
The Group makes estimates and assumptions concerning the future. These estimates and judgments are continually evaluated and are based on historical experience and other factors, including expectations of future events that are believed to be reasonable under the circumstances. The resulting accounting estimates will, by definition, seldom equal the related actual results. The estimates and assumptions that have a significant risk of causing a material adjustment to the carrying amounts of assets and liabilities or may have had a significant impact on the reported results are disclosed below:
Going concern
The Group’s accounts are prepared on a going concern basis. To date, the Group has financed its cash requirements primarily from share issuances, licensing certain of its research and development stage products and selling its allosteric modulator drug discovery technology platform with a portfolio of preclinical programs. The Group is a development - stage enterprise and is exposed to all the risks inherent in establishing a business. The Group expects that its existing cash and cash equivalents, at the issuance date of these consolidated financial statements will be sufficient to fund its operations and meet all of its obligations as they fall due, through mid-June 2026. The future viability of the Group is dependent on its ability to raise additional capital through public or private financings or collaboration agreements to finance its future operations, which may be delayed due to reasons outside of the Group’s control including health pandemics and geopolitical risks. The sale of additional equity may dilute existing shareholders. The inability to obtain funding, as and when needed, would have a negative impact on the Group’s financial condition and ability to pursue its business strategies. If the Group is unable to obtain the required funding to run its operations and to develop and commercialize its product candidates, the Group could be forced to delay, reduce or stop some or all of its research and development programs to ensure it remains solvent. Management continues to explore options to obtain additional funding, including through collaborations with third parties related to the future potential development and/or commercialization of its product candidates. However, there is no assurance that the Group will be successful in raising funds, closing collaboration agreements, obtaining sufficient funding on terms acceptable to the Group, or if at all, which could have a material adverse effect on the Group’s business, results of operations and financial condition.
The Business of the Group could be adversely affected by health pandemics and geopolitical risks
The business of the Group could be adversely affected by health epidemics and geopolitical risks in regions where the Group or partners have concentrations of clinical trial sites or other business operations and could cause significant disruption in the operations of third-party manufacturers and CROs upon whom the Group or partners rely. Health pandemics may pose the risk that the Group, employees, contractors, collaborators, and partners may be prevented from conducting certain pre-clinical tests, clinical trials or other business activities for an indefinite period of time, including due to travel restrictions, quarantines, “stay-at-home” and “shelter-in-place” orders or shutdowns that have been or may in the future be requested or mandated by governmental authorities. For example, the COVID-19 pandemic has impacted the business of the Group and clinical trials led by the Group or partners, including as a result of delays or difficulties in clinical site initiation, difficulties in recruiting and retaining clinical site investigators and clinical site staff and interruption of the clinical supply chain or key clinical trial activities, such as clinical trial site monitoring, and supply chain interruptions caused by restrictions for the supply of materials for drug candidates or other materials necessary to manufacture product to conduct clinical and preclinical tests. Geopolitical risks such as Russia-Ukraine war or Middle East conflict may create global security concerns including the possibility of an expanded regional or global conflict and potential ramifications such as disruption of the supply chain including research and development activities being conducted by the Group and its strategic partners. Delays in research and development activities of the Group and its partners could increase associated costs and, depending upon the duration of any delays, require the Group and its partners to find alternative suppliers at additional expense. In addition, Russia-Ukraine war has had significant ramifications on global financial markets, which may adversely impact the ability of the Group to raise capital on favorable terms or at all.
F-20
Discontinued operations related to the Neurosterix Transaction
On April 2, 2024, the Group sold a part of its business constituting its allosteric modulator drug discovery technology platform and a portfolio of preclinical programs (note 23). As a consequence, the Group recognized discontinued operations in the statements of profit or loss under “net profit or loss from discontinued operations” for the twelve-month period ended December 31, 2024 and 2023 respectively, in accordance with IFRS 5. The Group identified as well, cash flows from discontinued operations for the twelve-month period ended December 31, 2024 and 2023, respectively (note 23). The identification of discontinued operations may require some degree of judgement.
Investments accounted for using the equity method
The Group received an equity interest of
Revenue recognition
Revenue is primarily from fees related to licenses, milestones and research services. Given the complexity of the relevant agreements, judgements are required to identify distinct performance obligations, allocate the transaction price to these performance obligations and determine when the performance obligations are met. In particular, the Group’s judgement over the estimated stand-alone selling price which is used to allocate the transaction price to the performance obligations is disclosed in note 16.
Grants
Grants are recorded at their fair value when there is reasonable assurance that they will be received and recognized as income when the Group has satisfied the underlying grant conditions. In certain circumstances, grant income may be recognized before explicit grantor acknowledgement that the conditions have been met.
Accrued research and development costs
The Group records accrued expenses for estimated costs of research and development activities conducted by third party service providers. The Group records accrued expenses for estimated costs of research and development activities based upon the estimated amount of services provided, but not yet invoiced, and these costs are included in accrued expenses on the balance sheets and within research and development expenses in the statements of profit or loss. These costs are a significant component of research and development expenses. Accrued expenses for these costs are recorded based on the estimated amount of work completed in accordance with agreements established with these third parties.
Due to the nature of estimates, the Group may be required to make changes to the estimates after a reporting period as it becomes aware of additional information about the status or conduct of its research activities.
F-21
Share-based compensation
The Group recognizes an expense for share-based compensation based on the valuation of equity incentive units using the Black-Scholes valuation model. A number of assumptions related to the volatility of the underlying shares and to the risk-free rate are made in this model. Should the assumptions and estimates underlying the fair value of these instruments vary significantly from management’s estimates, then the share-based compensation expense would be materially different from the amounts recognized. Had these assumptions been modified within their feasible ranges, i.e. a
Equity instruments
The group records in equity the pre - funded warrants sold to investors and the warrants granted to investors at a fair value calculated using Black - Scholes model.
Pension obligations
The present value of the pension obligations is calculated by an independent actuary and depends on a number of assumptions that are determined on an actuarial basis such as discount rates, future salary and pension increases, and mortality rates. Any changes in these assumptions will impact the carrying amount of pension obligations. The Group determines the appropriate discount rate at the end of each period. This is the interest rate that should be used to determine the present value of estimated future cash outflows expected to be required to settle the pension obligations. In determining the appropriate discount rate, the Group considers the interest rates of high-quality corporate bonds that are denominated in the currency in which the benefits will be paid, and that have terms to maturity approximating the terms of the related pension liability. Other key assumptions for pension obligations are based in part on current market conditions. Additional information is disclosed in note 21.
5. Segment information
Management has identified
Information about products, services and major customers
External income of the Group for the years ended December 31, 2024, 2023 and 2022 is derived from the business of discovery, development and commercialization of pharmaceutical products. Income was earned from rendering of research services to a pharmaceutical company and grants earned.
Information about geographical areas
External income is exclusively recorded in the Swiss operating company.
Analysis of revenue from contract with customer and other income by nature is detailed as follows:
| 2024 |
| 2023* |
| 2022* | |
Collaborative research funding |
| | | | ||
Other service income |
| | | | ||
Total |
| | | |
F-22
Analysis of revenue from contract with customer and other income by major counterparties is detailed as follows:
| 2024 |
| 2023* |
| 2022* | |
Indivior PLC |
| | | | ||
Other counterparties |
| | | | ||
Total |
| | | |
For more detail, refer to note 16, “Revenue from contract with customer” and note 17 “Other Income”.
The geographical allocation of long-lived assets is detailed as follows:
| December 31, |
| December 31, | |
2024 | 2023 | |||
Switzerland |
| | | |
France |
| | | |
Total |
| | |
The geographical analysis of operating costs is as follows:
| 2024 |
| 2023* |
| 2022* | |
Switzerland |
| | | | ||
United States of America | | | | |||
France |
| | | | ||
Total operating costs (note 18) |
| | | |
There was capital expenditure of CHF
6. Cash and cash equivalents
| December 31, |
| December 31, | |
2024 | 2023 | |||
Cash at bank and on hand |
| | | |
Total cash and cash equivalents |
| | |
Split by currency:
| December 31, |
| December 31, |
| |
2024 | 2023 |
| |||
CHF |
| % | % | ||
USD |
| % | % | ||
EUR |
| % | % | ||
GBP |
| % | % | ||
Total |
| % | % |
The Group earns interest on USD cash and cash equivalents and no longer pays interest on CHF cash and cash equivalents from the third quarter of 2022. The Group invests its cash balances into a variety of current and deposit accounts mainly with
All cash and cash equivalents were held either at banks or on hand as of December 31, 2024 and December 31, 2023.
F-23
Credit quality of cash and cash equivalents
The table below shows the cash and cash equivalents by credit rating of the major counterparties:
| December 31, |
| December 31, | |
2024 | 2023 | |||
External credit rating of counterparty | ||||
P-1 / A-1 |
| | | |
P-2 / A-1 | | | ||
Other | | | ||
Cash on hand |
| | | |
Total cash and cash equivalents |
| | |
External credit ratings of counterparties were obtained from Moody’s (P-) or Standard & Poor’s (A-)
7. Other current assets
| December 31, |
| December 31, | |
2024 | 2023 | |||
Other financial assets |
| | | |
Trade and other receivables |
| | | |
Contract asset (Indivior PLC) |
| — | | |
Prepayments | | | ||
Other current assets | | — | ||
Total other current assets |
| | |
Other current assets decreased by CHF
F-24
8. Right-of-use assets
Year ended December 31, 2023 |
| Properties |
| Equipment |
| Total |
Opening net book amount |
| | | | ||
Depreciation charge |
| ( | ( | ( | ||
Effect of lease modifications | | — | | |||
Closing net book amount |
| | | | ||
As of December 31, 2023 |
| Properties |
| Equipment |
| Total |
Cost |
| | | | ||
Accumulated depreciation |
| ( | ( | ( | ||
Net book value |
| | | | ||
Year ended December 31, 2024 |
| Properties |
| Equipment |
| Total |
Opening net book amount | | | | |||
Depreciation charge | ( | ( | ( | |||
Effect of lease modifications | | — | | |||
Disposals | ( | — | ( | |||
Assets transferred to Neurosterix Pharma Sàrl | ( | ( | ( | |||
Closing net book amount | | — | | |||
As of December 31, 2024 |
| Properties |
| Equipment |
| Total |
Cost | | — | | |||
Accumulated depreciation | ( | — | ( | |||
Net book value | | — | |
The gross value of the right of use assets decreased by CHF
The total cash outflows for the principal element of lease payment amounted to CHF
F-25
9. Property, plant and equipment
|
| Furniture & |
| Chemical |
| |||
Year ended December 31, 2023 | Equipment | fixtures | library | Total | ||||
Opening net book amount |
| | — | — | | |||
Additions |
| | — | — | | |||
Depreciation charge |
| ( | — | — | ( | |||
Closing net book amount |
| | — | — | | |||
|
| Furniture & |
| Chemical |
| |||
As of December 31, 2023 | Equipment | fixtures | library | Total | ||||
Cost |
| | | | | |||
Accumulated depreciation |
| ( | ( | ( | ( | |||
Net book value |
| | — | — | | |||
|
| Furniture & |
| Chemical |
| |||
Year ended December 31, 2024 | Equipment | fixtures | library | Total | ||||
Opening net book amount |
| | — | — | | |||
Additions |
| | — | — | | |||
Depreciation charge |
| ( | — | — | ( | |||
Assets transferred to Neurosterix Pharma Sàrl | ( | — | — | ( | ||||
Closing net book amount |
| | — | — | | |||
|
| Furniture & |
| Chemical |
| |||
As of December 31, 2024 | Equipment | fixtures | library | Total | ||||
Cost |
| | — | — | | |||
Accumulated depreciation |
| ( | — | — | ( | |||
Net book value |
| | — | — | |
The gross value of property, plant and equipment decreased by CHF
For the year ended December 31, 2024, the Group recorded a depreciation charge of CHF
10. Intangible assets
Service |
| |||
Period ended December 31, 2024 |
| agreement |
| Total |
Opening net book amount | — | — | ||
Additions | | | ||
Depreciation charge | ( | ( | ||
Closing net book amount | — | — |
| Service |
| ||
As of December 31, 2024 | agreement | Total | ||
Cost | | | ||
Accumulated depreciation |
| ( |
| ( |
Net book value |
| — |
| — |
The service agreement relates to staff and infrastructure provided by Neurosterix Pharma Sàrl at zero cost in accordance with the Neurosterix Transaction (note 23). The depreciation charge was recognized at the rate at which these services were provided.
F-26
11. Non-current financial assets
| December 31, |
| December 31, | |
2024 | 2023 | |||
Security rental deposits |
| |
| |
Total non‑current financial assets |
| |
| |
Security rental deposits relate to office space. The applicable interest rate to such deposits is immaterial, and therefore, the value approximates amortized cost.
12. Payables and accruals
| December 31, |
| December 31, | |
2024 | 2023 | |||
Trade payables |
| | | |
Social security and other taxes |
| | | |
Accrued expenses |
| | | |
Total payables and accruals |
| | |
All payables mature within
13. Deferred income
The Group expects the deferred income to be recognized as follows:
December 31, 2024 |
| December 31, 2023 | ||
Expected income recognition in year one after the balance sheet date |
| — |
| |
Expected income recognition in year two after the balance sheet date |
| — |
| |
Total deferred income |
| — |
| |
The deferred income relates to a grant from Eurostars/Innosuisse. See note 17 “other income” for further information related to the Eurostars/Innosuisse project.
F-27
14. Share capital
Number of shares | ||||||
| Common |
| Treasury |
| ||
shares | shares | Total | ||||
Balance as of January 1, 2023 |
| |
| ( |
| |
Issue of shares - treasury shares | | ( | — | |||
Issue of shares - exercise ESOP | | — | ||||
Sale of shares under shelf registration | — | | ||||
Exercise of pre-funded warrants(1) | | — | ||||
Sale of shares under sale agency agreement |
| — |
| |
| |
Net purchase of shares under liquidity agreement |
| — |
| ( |
| ( |
Acquisition of shares forfeited from DSPPP | — | ( | ( | |||
Balance as of December 31, 2023 |
| |
| ( |
| |
Shares reclassed as treasury shares under IFRS 2 | — | ( | ( | |||
Balance as of December 31, 2023 IFRS 2 | | ( | | |||
Number of shares | ||||||
Common | Treasury | |||||
| shares |
| shares |
| Total | |
Balance as of January 1, 2024(1) | | ( | | |||
Sale of shares under sale agency agreement | — | | | |||
Net sale of shares under liquidity agreement | — | | | |||
Acquisition of shares forfeited from DSPPP | — | ( | ( | |||
Balance as of December 31, 2024 | | ( | | |||
Shares reclassed as treasury shares under IFRS 2 | — | ( | ( | |||
Balance as of December 31, 2024 IFRS 2 |
| |
| ( |
| |
(1) In accordance with Swiss law, the issuance of
As of December 31, 2024,
The Group maintains a liquidity agreement with Kepler Cheuvreux (“Kepler”). Under the agreement, the Group has provided Kepler with cash and shares to enable them to buy and sell the Company’s shares. As of December 31, 2024,
During the year 2024, the Group sold
On February 20, 2024, in accordance with Swiss law, the company registered in the commercial register
F-28
On December 13, 2023, the company increased its capital from CHF
On October 23, 2023, the ADS ratio was changed from one ADS to
On June 14, 2023, the Company increased its capital from CHF
On April 3, 2023, the Group entered into a securities purchase agreement with an institutional investor. The Group sold
15. Share-based compensation
The total share-based compensation expense recognized as continuing operating costs in the statement of comprehensive profit or loss for equity incentive units granted to Board Members, Executive Managers, employees and consultants has been recorded under the following headings:
| 2024 |
| 2023 |
| 2022 | |
Research and development |
| | | | ||
General and administration |
| | | | ||
Total share-based compensation for continuing operations |
| | | |
F-29
The total share-based compensation expense recognized as discontinued operating costs in the statement of comprehensive profit or loss under “net profit or loss from discontinued operations” for equity incentive units granted to Board Members, Executive Managers, employees and consultants has been recorded under the following headings:
| 2024 |
| 2023 |
| 2022 | |
Research and development |
| | | | ||
General and administration |
| | | | ||
Total share-based compensation for discontinued operations |
| | | |
As part of the Neurosterix Transaction executed on April 2, 2024, the accelerated vesting of equity incentive units of employees and Executive Managers transferred to Neurosterix Pharma Sàrl amounted to CHF
The share-based compensation expense recognized as discontinued operations decreased by CHF
Equity Sharing Certificate Equity Incentive Plan
On June 1, 2010, the Company established an equity incentive plan based on equity sharing certificates (“ESCs”) to provide incentives to Board Members, Executive Managers, employees and consultants of the Group. Each ESC provides the holder (i) a right to subscribe for
Movements in the number of share subscription rights attached to the ESCs outstanding are as follows:
Average | ||||
subscription | ||||
prices / floor | ||||
| prices (CHF) |
| 2022 | |
At January 1 |
| | | |
Exercised under the DSPPP | | ( | ||
At December 31 |
| | |
At December 31, 2024, 2023 and 2022, there are
Employee share option plans (ESOP)
The Company established an employee share option plan to provide incentives to directors, executives, employees and consultants of the Group.
During 2024, the Group granted
F-30
During 2023, the Group granted the following options with vesting over
|
|
| Number of share |
| Number of |
| ||||
options granted | share | Number of | ||||||||
for continuing | options repriced | options exercised | ||||||||
Strike price at | Expiry date at | and discontinued | to CHF | under | ||||||
grant date | grant date | operations | November 27 2023 | the DSPPP | ||||||
January 1, 2023 |
| |
| Dec. 31, 2032 |
| |
| — |
| — |
May 12, 2023 |
| |
| May 11, 2033 |
| |
| |
| |
July 1, 2023 |
| | June 30, 2033 |
| |
| — |
| — | |
Total 2023 |
|
|
| |
| |
| |
In 2023,
During 2022, the Group granted the following options with vesting over
Number of share | Number of | Number of | ||||||||||
options granted | share options | share options | Number of | |||||||||
for continuing | repriced to | repriced to | options exercised | |||||||||
Strike price at | Expiry date at | and discontinued | CHF | CHF | under | |||||||
| grant date |
| grant date |
| operations |
| August 2 2022 |
| October 5 2022 |
| the DSPPP | |
April 12, 2022 | | April 11, 2032 | | | | | ||||||
April 12, 2022 | | Dec. 31, 2031 | | | | | ||||||
April 12, 2022 | | Dec. 31, 2031 | | — | — | — | ||||||
May 2, 2022 | | May 1, 2032 | | | | | ||||||
October 5, 2022 | | Oct. 4, 2032 | | — | — | | ||||||
October 6, 2022 | | Oct. 5, 2032 | | — | — | | ||||||
December 29, 2022 | | June 30, 2032 | | — | — | — | ||||||
Total 2022 | | | | |
In 2022, the Group granted
Movements in the number of options outstanding are as follows:
Average | Average | Average | ||||||||||
strike price | strike price | strike price | ||||||||||
| (CHF) |
| 2024 |
| (CHF) |
| 2023 |
| (CHF) |
| 2022 | |
At January 1 |
| |
| |
| |
| | | | ||
Exercised under the DSPPP | — | — | | ( | | ( | ||||||
Granted |
| |
| |
| |
| | | | ||
Forfeited | | ( | — | — | | ( | ||||||
At December 31 |
| |
| |
| |
| | | |
At December 31, 2024, of the outstanding
F-31
The outstanding share options as at December 31, 2024 and 2023 have the following expiry dates:
At December 31, 2024 | Range of strike prices (CHF) | |||||||||
Expiry date |
| 0.043 to 0.106 |
| 0.13 |
| 0.14 to 0.99 |
| 1.00 to 3.00 |
| Total |
2025 |
| — |
| — |
| |
| |
| |
2027 |
| — |
| |
| |
| |
| |
2028 | — | | | | | |||||
2029 |
| — |
| — |
| — |
| |
| |
2030 |
| — |
| |
| — |
| |
| |
2031 | — | | — | | | |||||
2032 | | | | — | | |||||
2033 | | — | — | — | | |||||
2034 | | — | — | — | | |||||
Total |
| |
| |
| |
| |
| |
At December 31, 2023 | Range of strike prices (CHF) | |||||||||
Expiry date |
| 0.043 to 0.106 |
| 0.13 |
| 0.14 to 0.99 |
| 1.00 to 3.00 |
| Total |
2025 |
| — |
| — |
| |
| |
| |
2027 |
| — |
| |
| |
| |
| |
2028 | — | | | | | |||||
2029 | — | — | — | | | |||||
2030 | — | | — | | | |||||
2031 | — | | — | | | |||||
2032 | | | | — | | |||||
2033 | | — | — | — | | |||||
Total |
| |
| |
| |
| |
| |
The weighted average fair value of share options granted during 2024 determined using a Black-Scholes model was CHF
| 2024 |
| 2023 |
| 2022 | ||
Weighted average share price per share at the grant date |
| CHF |
| CHF | CHF | ||
Weighted average strike price per share |
| CHF |
| CHF | CHF | ||
Weighted average volatility (1) |
| | % | | % | | % |
Weighted average expected option life (years) | | | | ||||
Dividend yield |
| — |
| — | — | ||
Weighted average annual risk-free rate |
| | % | | % | | % |
(1) The expected volatility is based on historical share prices of the company
F-32
Deferred Strike Price Payment Plan (DSPPP)
The Group has implemented a staff retention plan which includes a DSPPP which encourages Board Members, Executive Managers and employees to exercise their share options or equity sharing certificates and become shareholders of the Company by allowing the deferral of the obligation to pay the strike price until the earlier of the sale of the shares or
Movements in the number of DSPPP shares are as follows:
| Average |
|
| Average |
|
| Average |
| ||||
deferred strike | deferred strike | deferred strike | ||||||||||
price payment | price payment | price payment | ||||||||||
(CHF) | 2024 | (CHF) | 2023 | (CHF) | 2022 | |||||||
At January 1 | | | ||||||||||
Forfeited | ( | ( | | | ||||||||
Granted - exercise of ESOP & ESC | — | — | | | | |||||||
At December 31 | | | | |
On November 27, 2023 and October 26, 2022, Board Members, Executive Managers and employees exercised
The DSPPP has the following expiry dates as at December 31, 2024 and 2023:
At December 31, 2024 |
| Range of strike prices (CHF) | ||||
Expiry date |
| 0.043 |
| 0.13 |
| Total |
2033 |
| — |
| |
| |
2034 |
| |
| — |
| |
Total |
| |
| |
| |
At December 31, 2023 |
| Range of strike prices (CHF) | ||||
Expiry date | 0.043 |
| 0.13 |
| Total | |
2032 |
| — |
| |
| |
2033 |
| |
| — |
| |
Total |
| |
| |
| |
F-33
16. Revenue from contract with customer
License & research agreement with Indivior PLC
On January 2, 2018, the Group entered into an agreement with Indivior for the discovery, development and commercialization of novel GABAB PAM compounds for the treatment of addiction and other CNS diseases. This agreement included the selected clinical candidate, ADX71441. In addition, Indivior agreed to fund a research program at the Group to discover novel GABAB PAM compounds.
The contract contains
Indivior has sole responsibility, including funding liability, for development of selected compounds under the agreement through preclinical and clinical trials, as well as registration procedures and commercialization, if any, worldwide. Indivior has the right to design development programs for selected compounds under the agreement. Through the Group’s participation in a joint development committee, the Group reviews, in an advisory capacity, any development programs designed by Indivior. However, Indivior has authority over all aspects of the development of such selected compounds
Under terms of the agreement, the Group granted Indivior an exclusive license to use relevant patents and know-how in relation to the development and commercialization of product candidates selected by Indivior. Subject to agreed conditions, the Group and Indivior jointly own all intellectual property rights that are jointly developed and the Group or Indivior individually own all intellectual property rights that the Group or Indivior develop individually. The Group has retained the right to select compounds from the research program for further development in areas outside the interest of Indivior including chronic cough. Under certain conditions, but subject to certain consequences, Indivior may terminate the agreement.
In January 2018, the Group received, under the terms of the agreement, a non-refundable upfront fee of USD
On February 14, 2019, Indivior terminated the development of their selected compound, ADX71441. Separately, Indivior funds research at the Group, based on a research plan to be mutually agreed between the parties, to discover novel GABAB PAM compounds. These future novel GABAB PAM compounds, if selected by Indivior, become licensed compounds. The Group agreed with Indivior to an initial research term and duration of
F-34
For the year ended December 31, 2024, the Group recognized CHF
Janssen Pharmaceuticals Inc. (formerly Ortho-McNeil-Janssen Pharmaceuticals Inc.)
On December 31, 2004, the Group entered into a research collaboration and license agreement with Janssen Pharmaceuticals Inc. (JPI). In accordance with this agreement, JPI has acquired an exclusive worldwide license to develop mGlu2 PAM compounds for the treatment of human health. The Group is eligible to receive up to EUR
In 2024, Janssen completed a Phase 2a proof of concept clinical trial of ADX71149 in epilepsy patients that did not achieve statistical significance for the primary endpoint of time for patients to reach baseline seizure count when ADX71149 was added to standard of care and decided to terminate the development of ADX71149. On April 17, 2025, the Group announced that the license agreement had been terminated and the program and all related intellectual property has been returned to the Group.
17. Other income
Under grant agreements with Eurostars/Innosuisse the Group was required to complete specific research activities within a defined period of time. The Group’s funding was fixed and received based on the satisfactory completion of the agreed research activities and incurring the related costs.
In September 2023, the Group was awarded a grant of CHF
The Group additionally recognized other income from IT consultancy agreements.
18. Operating costs
| 2024 |
| 2023* |
| 2022* | |
Staff costs (note 19) |
| | | | ||
Depreciation (notes 8/9) |
| | | | ||
External research and development costs |
| | | | ||
Patent maintenance and registration costs |
| | | | ||
Professional fees |
| | | | ||
D&O insurance | | | | |||
Other operating costs |
| | | | ||
Total operating costs |
| | | |
The evolution of the total operating costs is mainly driven by external research and development expenses, staff costs, D&O insurance, professional fees and other operating costs.
During the year ended December 31, 2024, total operating costs recognized as continuing operations decreased by CHF
F-35
During the year ended December 31, 2023, total operating costs recognized as continuing operations decreased by CHF
During the year ended December 31, 2022, 2023 and 2024, total operating costs recognized as discontinued operations amounted to CHF
19. Staff costs
| 2024 |
| 2023* |
| 2022* | |
Wages and salaries |
| | | | ||
Social charges and insurances |
| | | | ||
Value of share-based services (note 15) |
| | | | ||
Retirement benefit (note 21) |
| ( | | | ||
Total staff costs |
| | | |
During the twelve-month periods ended December 31, 2022, 2023 and 2024, staff costs recognized as continuing operations remained stable around CHF
During the twelve-month periods ended December 31, 2022, 2023 and 2024, staff costs recognized as discontinued operations amounted to CHF
20. Taxes
| December 31, 2024 |
| December 31, 2023 |
| December 31, 2022 | |
Net (loss) from continuing operations before tax | ( | ( | ( | |||
Net gain / (loss) before tax of discontinued operations | | ( | ( | |||
Net gain / (loss) before tax |
| |
| ( |
| ( |
Tax calculated at a tax rate of |
| ( |
| |
| |
Effect of different tax rates in USA and France |
| |
| |
| |
Deductible expenses charged against equity for issuance of shares |
| |
| |
| |
Sale of treasury shares by a subsidiary, recognized as financial loss / (income) in standalone financial statements | ( | | | |||
Net loss incurred by Neurosterix Pharma Sàrl from March 19 2024 to April 1, 2024 1 | | — | — | |||
Expenses not deductible for tax purposes |
| ( |
| ( |
| ( |
Permanent difference related to investments accounted for using the equity method | | — | — | |||
Other temporary differences | — | ( | ( | |||
Total tax not recognized as deferred tax (asset) / liability |
| |
| ( |
| ( |
Income tax expense for continuing operations | — | — | — | |||
Income tax expense for discontinued operations |
| — |
| — |
| — |
(1) | The Group lost the control of its subsidiary Neurosterix Pharma Sàrl on April 2, 2024, as part of the divestment of a part of its business (note 23). |
The Group has decided
The amount of deferred income tax assets that arises from sources other than tax losses carried forward and the amount of deferred income tax liabilities remain insignificant compared to the unrecognized tax losses carried forward as of December 31, 2024.
F-36
The tax losses carried forward by the Group and their respective expiry dates are as follows:
| December 31, 2024 |
| December 31, 2023 |
| December 31, 2022 | |
2023 |
| — | — | | ||
2024 |
| — | |
| | |
2025 |
| | |
| | |
2026 |
| |
| |
| |
2027 |
| |
| |
| |
2028 |
| |
| | | |
2029 | |
| | | ||
2030 | | | — | |||
2031 | | — | — | |||
Total unrecorded tax losses carry forwards |
| |
| | |
As of December 31, 2024, the unrecorded tax losses carried forward amounted to CHF
21. Retirement benefit obligations
Apart from the social security plans fixed by the law, the Group sponsors an independent pension plan. The Group has contracted with Swiss Life for the provision of occupational benefits. All benefits in accordance with the regulations are reinsured in their entirety with Swiss Life within the framework of the corresponding contract. This pension solution fully reinsures the risks of disability, death and longevity with Swiss Life. Swiss Life invests the vested pension capital and provides a
Employment benefit obligations
The amounts recognized in the balance sheet are determined as follows:
December 31, | December 31, | |||
| 2024 |
| 2023 | |
Defined benefit obligation |
| ( |
| ( |
Fair value of plan assets |
| |
| |
Shortfall on Funded status |
| ( |
| ( |
The shortfall on funded status amounted to CHF
F-37
The amounts recognized as continuing operations in the statement of comprehensive profit or loss are as follows:
| 2024 |
| 2023 |
| 2022 | |
Current service cost |
| ( | ( | ( | ||
Past service cost | | | | |||
Interest cost |
| ( | ( | ( | ||
Interest income |
| | | | ||
Company pension gain / (cost) (note 19) |
| | ( | ( |
The past service cost of CHF
The amounts recognized as discontinued operations in the statement of comprehensive profit of loss under “net profit or loss from discontinued operations” are as follows:
| 2024 |
| 2023 |
| 2022 | |
Current service cost | ( | ( | ( | |||
Past service cost | | | | |||
Interest cost | ( | ( | ( | |||
Interest income | | | | |||
Company pension amount (note 23) | ( | ( | ( |
Pension costs related to discontinued activities decreased by CHF
The movements in the defined benefit obligations during the year are as follows:
| 2024 |
| 2023 | |
Defined benefit obligation at beginning of year |
| ( | ( | |
Current service cost |
| ( | ( | |
Past service cost |
| | | |
Interest cost | ( | ( | ||
Employee contributions |
| ( | ( | |
Actuarial (loss)/ gain arising from changes in financial assumptions |
| ( | ( | |
Actuarial gain arising from changes in demographic assumptions |
| — | — | |
Actuarial gain on experience adjustment |
| ( | | |
Benefits (paid)/ deposited |
| | ( | |
Defined benefit obligations at end of year |
| ( | ( |
The movements in the fair value of plan assets during the year are as follows:
| 2024 |
| 2023 | |
Fair value of plan assets at beginning of year |
| | | |
Interest income |
| | | |
Employee contributions |
| | | |
Employer contributions |
| | | |
Plan assets loss |
| | ( | |
Benefits paid |
| ( | | |
Fair value of plan assets at end of year |
| | |
F-38
The defined benefit obligations and the fair value of the plan assets decreased between the twelve-month periods ended December 31, 2024 and 2023 primarily due to a reduced number of employees due to the sale of a part of our business on April 2, 2024 (note 23).
As of the date of the preparation of these consolidated financial statements, the 2024 annual report of the pension fund has not yet been issued, and therefore the detailed structures and assets held at December 31, 2024, are not currently available for presentation. However, the detailed assets held at December 31, 2023, which were reported to the Group on May 13, 2024 by its plan administrator, are as follows:
| December 31, |
| |
2023 |
| ||
Cash |
| | % |
Bonds |
| | % |
Equity instruments |
| | % |
Real estate |
| | % |
Mortgages |
| | % |
Derivatives | | % | |
Total |
| | % |
The principal actuarial assumptions used were as follows:
| December 31, 2024 |
| December 31, 2023 |
| |
Discount rate |
| | % | | % |
Mortality tables |
| BVG2020 GT |
| BVG2020 GT | |
Salary growth rate | | % | | % | |
Pension growth rate | | % | | % |
The following sensitivity analysis shows the impact of increasing or decreasing certain assumptions on the defined benefit obligation of the Swiss pension plan:
-
- |
- |
- | +/- |
The discount rate and life expectancy were identified as significant actuarial assumptions for the Swiss pension plan.
The above sensitivity analyses are based on a change in an assumption while holding all other assumptions constant. In practice, this is unlikely to occur, and changes in some of the assumptions may be correlated. When calculating the sensitivity of the defined benefit obligations to significant actuarial assumptions the same method (present value of the defined benefit obligation calculated with the projected unit credit method at the end of the reporting period) has been applied as that used in calculating the pension liability recorded on consolidated balance sheets.
The methods and types of assumptions used in preparing the sensitivity analysis did not change compared to the prior period.
F-39
The estimated employer contributions to pension plans for the financial year 2025 amount to CHF
The following table shows the components of the costs recognized in other comprehensive income, related to continuing operations:
| 2024 |
| 2023 | |
Actuarial (loss)/ gain on defined benefit obligation | ( | ( | ||
Actuarial loss on plan assets | | ( | ||
Change in the effect of the asset ceiling | — | | ||
Total |
| ( |
| ( |
The following table shows the components of the costs recognized in other comprehensive income, related to discontinued operations:
| 2024 |
| 2023 | |
Actuarial (loss)/ gain on defined benefit obligation | ( | ( | ||
Actuarial loss on plan assets | | ( | ||
Change in the effect of the asset ceiling | — | | ||
Total | ( | ( |
The following table shows the estimated benefit payments related to employee and employer contributions for the next ten years where the number of employees remains constant:
2025 |
| |
2026 |
| |
2027 |
| |
2028 |
| |
2029 | | |
2030-2034 |
| |
22. Finance result, net
| 2024 |
| 2023* |
| 2022* | |
Interest income |
| | | | ||
Interest expense on leases | ( | ( | ( | |||
Interest cost | ( | ( | ( | |||
Foreign exchange net gain / (losses) |
| | ( | ( | ||
Finance result, net |
| | ( | ( |
The evolution of the finance result net related to continuing operations is primarily driven by foreign exchanges differences on U.S Dollar cash deposits whose amount has been reduced between the twelve-month period ended December 31, 2024 and 2023.
23. Discontinued operations
On February 8, 2024, the Group signed a non-binding term sheet with Perceptive Advisors related to the divestment of part of its business. On April 2, 2024, the sale became effective. The allosteric modulator drug discovery technology platform and a portfolio of preclinical programs have been divested to a new Swiss company, Neurosterix Pharma Sàrl that has received committed funding of USD
F-40
As the allosteric modulator drug discovery technology platform and a portfolio of preclinical programs have been sold on April 2, 2024, such activities have been identified as discontinued operations for the year ended December 31, 2023 and for the period beginning on January 1, 2024 and terminating on April 1, 2024.
Financial performance of discontinued operations:
| 2024 |
| 2023 |
| 2022 | |
Other income | | | — | |||
Research and development | ( | ( | ( | |||
General and administration | ( | ( | ( | |||
Total operating costs | ( | ( | ( | |||
Operating loss | ( | ( | ( | |||
Finance expense | ( | ( | ( | |||
Net loss before tax | ( | ( | ( | |||
Income tax expense | — | — | — | |||
Net loss from discontinued operations | ( | ( | ( | |||
Net gain / (loss) of the sale of activities after income tax | | — | — | |||
Total net gain / (loss) from Discontinued operations | | ( | ( |
Operating costs of discontinued operations:
| 2024 |
| 2023 |
| 2022 | |
Staff costs | | | | |||
Depreciation | | | | |||
External research and development cost | | | | |||
Laboratory consumables | | | | |||
Patent maintenance and registration costs | | | | |||
Professional fees | | — | | |||
Short-term leases | | | | |||
Other operating costs | | | | |||
Total discontinued operating costs | | | |
Discontinued operating costs are primarily driven by staff and external research and development costs.
F-41
Cash flows of discontinued operations:
| 2024 |
| 2023 |
| 2022 | |
Net profit / (loss) from discontinued operations | | ( | ( | |||
Adjustments for: |
|
|
| |||
Net gain on Neurosterix Transaction | ( | — | — | |||
Value of share-based services | | | | |||
Post-employment benefits | ( | ( | ( | |||
Depreciation | | | | |||
Net gain related to lease modifications | — | ( | — | |||
Finance cost net | | | | |||
Decrease / (increase) in trade and other receivables | | | | |||
Decrease / (increase) in prepayments | ( | | | |||
Increase in other current assets | ( | — | — | |||
Increase / (decrease) in payables and accruals | ( | | ( | |||
Increase / (decrease) in deferred income | ( | | — | |||
Net cash flow used in operating activities | ( | ( | ( | |||
Net cash flow from / (used in) investing activities |
|
|
| |||
Cash received from Neurosterix Transaction | | — | — | |||
Legal fees paid for Neurosterix Transaction | ( | — | — | |||
Purchase of property, plant and equipment | — | ( | ( | |||
Net cash from / (used) in investing activities | | ( | ( | |||
Cash flows used in financing activities |
|
|
| |||
Principal element of lease payment | ( | ( | ( | |||
Interest paid | ( | ( | ( | |||
Net cash used in financing activities | ( | ( | ( | |||
Net cash from / (used in) discontinued activities | | ( | ( |
Net cash flow from discontinued activities amounts to CHF
F-42
Details of the net gain of the sale of activities:
| 2024 | |
Consideration received |
| |
Cash in from Neurosterix Pharma Sàrl sale | | |
Fair value of Neurosterix US Holdings LLC’s participation | | |
Net gain on Neurosterix Pharma Sàrl derecognition (IFRS10) | | |
Retirement benefit obligation of employees leaving the Group (IAS 19) | | |
Fair value of service agreement | | |
Net debt liabilities related to Neurosterix Pharma Sàrl (IFRS 16) | | |
Total disposal consideration | | |
Investment in Neurosterix Pharma Sàrl | ( | |
Legal fees paid for Neurosterix Transaction | ( | |
Accelerating vesting ESOP/DSPPP | ( | |
Total costs related to activities sold | ( | |
Net gain on sale before income tax | | |
Income tax expense on gain | — | |
Net gain on sale after income tax | |
As of December 31, 2024, the net fair value of the sales of activities amounted to CHF
24. Interests in associates
On April 2, 2024, the Group received an equity interest of
The carrying amount of the equity-accounted investment in Neurosterix’ Group has changed as follows during the year ended December 31, 2024:
| 2024 | |
Balance as of January 1, | — | |
Fair value of Neurosterix US Holdings LLC equity interest | | |
Share of net loss of Neurosterix’s Group | ( | |
Share of other comprehensive loss of Neurosterix’s Group | ( | |
Balance as of December 31, | |
The summarized financial information of Neurosterix Group is indicated as below :
| December 31, 2024 | |
Current assets |
| |
Non-current assets |
| |
Current liabilities |
| |
Non-current liabilities |
| |
Net assets (100%) |
| |
Group share of net assets ( |
| |
F-43
The carrying amount of the equity-accounted investment in Neurosterix’ Group amounts to CHF
| 2024 | |
Income |
| |
Net loss for the period |
| ( |
Other comprehensive loss |
| ( |
Total comprehensive loss |
| ( |
25. Profit or loss per share
Basic profit or loss per share is calculated by dividing the profit or loss attributable to equity holders of the Company by the weighted average number of outstanding shares.
Diluted profit per share is calculated by dividing the profit attributable to equity holders of the Company by the weighted average number of outstanding shares adjusted by outstanding options and warrants. Diluted loss per share is calculated excluding our options and warrants as they would be antidilutive and our treasury shares.
| 2024 |
| 2023 |
| 2022 | |
Net loss from continuing operations | ( | ( | ( | |||
Net profit / (loss) from discontinued operations | | ( | ( | |||
Net profit / (loss) attributable to equity holders of the company | | ( | ( | |||
Basic and diluted profit / (loss) per share | | ( | ( | |||
From continuing operations | ( | ( | ( | |||
From discontinued operations | | ( | ( |
| 2024 |
| 2023 |
| 2022 | |
Weighted average number of outstanding shares (1) |
| |
| | | |
Weighted average number of outstanding shares including share options and warrants (2) |
| |
| | |
| (1) | For the calculation of basic profit and loss per share and diluted loss per share |
| (2) | For the calculation of the diluted profit per share |
The Company has
In addition to treasury shares, the total number of dilutive instruments as of December 31, 2024 is
These options could potentially dilute basic earnings per share in the future.
F-44
26. Commitments and contingencies
Capital commitments
As at December 31, 2024 and 2023, the Group has
Contingencies
As part of the ordinary course of business, the Group is subject to contingent liabilities in respect of certain litigation. Currently, there is
27. Related party transactions
Related parties include members of the Board of Directors, the Executive Management of the Group and contracts with Neurosterix Group. The following transactions were carried out with related parties:
Key management compensation
| 2024 |
| 2023 |
| 2022 | |
Continuing operations | ||||||
Salaries, other short‑term employee benefits and post-employment benefits |
| |
| | | |
Consulting fees |
| — |
| | | |
Share‑based compensation |
| |
| | | |
Total |
| |
| | | |
| 2024 |
| 2023 |
| 2022 | |
Discontinued operations | ||||||
Salaries, other short‑term employee benefits and post-employment benefits | | | | |||
Share‑based compensation | | | | |||
Total | | | | |||
Salaries, other short-term employee benefits and post-employment benefits relate to members of the Board of Directors and Executive Management who are employed by the Group. Consulting fees relate mainly to Roger Mills, a member of the Executive Management who delivered his services to the Group under a consulting contract until 2023. The Group has a net payable to the Board of Directors and Executive Management of CHF
Transactions with Neurosterix Group
On April 2, 2024, Addex Group divested a part of its business to Neurosterix Pharma Sàrl (note 23). As part of the transaction, Addex Group received gross proceeds of CHF
28. Events after the balance sheet date
On April 17, 2025, the Group announced that Jansen terminated the license agreement for the development of ADX71149 and returned the program including all related intellectual property to the Group.
F-45
INDEPENDENT AUDITOR’S REPORT
Board of Directors
Neurosterix US Holdings LLC
Delaware
Opinion
We have audited the consolidated financial statements of Neurosterix US Holdings LLC and its subsidiaries (the Company), which comprise the consolidated balance sheet as of December 31, 2024, and the related consolidated statements of operations and comprehensive loss, members’ equity, and cash flows for the period from April 2, 2024 to December 31, 2024, and the related notes to the consolidated financial statements.
In our opinion, the accompanying consolidated financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2024, and the results of its operations and its cash flows for the period from April 2, 2024 to December 31, 2024 in accordance with accounting principles generally accepted in the United States of America.
Basis for Opinion
We conducted our audit in accordance with auditing standards generally accepted in the United States of America (GAAS). Our responsibilities under those standards are further described in the Auditor’s Responsibilities for the Audit of the Financial Statements section of our report. We are required to be independent of the Company and to meet our other ethical responsibilities, in accordance with the relevant ethical requirements relating to our audit. We believe that the audit evidence we have obtained is sufficient and appropriate to provide a basis for our audit opinion.
Responsibilities of Management for the Financial Statements
Management is responsible for the preparation and fair presentation of the consolidated financial statements in accordance with accounting principles generally accepted in the United States of America, and for the design, implementation, and maintenance of internal control relevant to the preparation and fair presentation of consolidated financial statements that are free from material misstatement, whether due to fraud or error.
In preparing the consolidated financial statements, management is required to evaluate whether there are conditions or events, considered in the aggregate, that raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date that the consolidated financial statements are available to be issued.
Auditor’s Responsibilities for the Audit of the Financial Statements
Our objectives are to obtain reasonable assurance about whether the consolidated financial statements as a whole are free from material misstatement, whether due to fraud or error, and to issue an auditor’s report that includes our opinion. Reasonable assurance is a high level of assurance but is not absolute assurance and therefore is not a guarantee that an audit conducted in accordance with GAAS will always detect a material misstatement when it exists. The risk of not detecting a material misstatement resulting from fraud is higher than for one resulting from error, as fraud may involve collusion, forgery, intentional omissions, misrepresentations, or the override of internal control. Misstatements are considered material if there is a substantial likelihood that, individually or in the aggregate, they would influence the judgment made by a reasonable user based on the consolidated financial statements.
In performing an audit in accordance with GAAS, we:
| ● | Exercise professional judgment and maintain professional skepticism throughout the audit. |
| ● | Identify and assess the risks of material misstatement of the consolidated financial statements, whether due to fraud or error, and design and perform audit procedures responsive to those risks. Such procedures include examining, on a test basis, evidence regarding the amounts and disclosures in the consolidated financial statements. |
F-46
| ● | Obtain an understanding of internal control relevant to the audit in order to design audit procedures that are appropriate in the circumstances, but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control. Accordingly, no such opinion is expressed. |
| ● | Evaluate the appropriateness of accounting policies used and the reasonableness of significant accounting estimates made by management, as well as evaluate the overall presentation of the consolidated financial statements. |
| ● | Conclude whether, in our judgment, there are conditions or events, considered in the aggregate, that raise substantial doubt about the Company’s ability to continue as a going concern for a reasonable period of time. |
We are required to communicate with those charged with governance regarding, among other matters, the planned scope and timing of the audit, significant audit findings, and certain internal control-related matters that we identified during the audit.
BDO AG
Christoph Tschumi | Nigel Le Masurier |
May 15, 2025, Zurich, Switzerland
F-47
F-48
Consolidated Balance Sheet
as at December 31, 2024
| December 31, 2024 | |||
| Notes |
| Amounts in USD | |
ASSETS | ||||
Current assets | ||||
Cash and cash equivalents |
| 5 |
| 20,797,039 |
Accounts receivable, net |
| 6 |
| 76,536 |
Prepaid expenses |
| 6 |
| 392,343 |
Other current assets |
| 6 |
| 206,034 |
Total current assets |
|
| 21,471,952 | |
Non-current assets |
|
|
|
|
Property, plant and equipment, net |
| 8 |
| 134,179 |
Operating lease right-of-use asset, net |
| 7 |
| 16,116 |
Goodwill |
| 9 |
| 5,287,591 |
Other intangible assets |
| 9 |
| 13,070,823 |
Total non-current assets |
|
| 18,508,709 | |
Total assets |
|
| 39,980,661 | |
LIABILITIES AND MEMBERS’ EQUITY |
|
|
|
|
Current liabilities |
|
|
|
|
Accounts payable and accrued expenses |
| 11 |
| 2,557,746 |
Operating lease liabilities, short-term |
| 7 |
| 3,522 |
Other liabilities – related party |
|
| 8,778 | |
Total current liabilities |
|
| 2,570,046 | |
Non-current liabilities |
|
|
|
|
Operating lease liabilities, long-term |
| 7 |
| 12,594 |
Employee benefit plan obligation |
| 18 |
| 768,640 |
Deferred tax liabilities |
| 17 |
| 1,921,411 |
Total non-current liabilities |
|
| 2,702,645 | |
Members’ equity |
|
|
|
|
Contributed capital (total: 92,857,142.86 units including: Class A: 83,571,428.57 units, Class B: 9,285,714.29 units) |
| 12 |
| 46,892,857 |
Additional paid-in capital |
| 13 |
| 1,067,007 |
Treasury units |
|
| (371) | |
Accumulated other comprehensive income |
|
| (928,814) | |
Retained earnings |
|
| (12,322,709) | |
Total member’s equity |
|
| 34,707,970 | |
Total liabilities and members’ equity |
|
| 39,980,661 |
The accompanying notes form an integral part of these consolidated financial statements.
F-49
Consolidated Statement of Operations and Comprehensive Loss
for the period from April 2, 2024 to December 31, 2024
| Period from April 2, | |||
| 2024 to December 31, | |||
| 2024 | |||
| Notes |
| Amounts in USD | |
Revenue |
|
|
|
|
Other income |
| 14 |
| 337,765 |
Total Net revenue |
|
| 337,765 | |
Operating expenses |
|
|
|
|
Research and development |
| 15 |
| (10,074,151) |
General and administrative |
| 15 |
| (2,365,668) |
Total operating expenses |
|
| (12,439,819) | |
Loss from operations |
|
| (12,102,054) | |
Non-operating income (expense) |
|
|
|
|
Finance income |
| 19 |
| 186 |
Finance expense |
| 19 |
| (220,841) |
Total non-operating expenses |
|
| (220,655) | |
Loss before income tax |
|
| (12,322,709) | |
Income tax expense |
|
| — | |
Net loss |
|
| (12,322,709) | |
Other comprehensive income / (loss) |
|
|
|
|
Remeasurements of retirement benefits obligation |
| 18 |
| (1,055,869) |
Foreign currency translation adjustment |
|
| 127,055 | |
Total other comprehensive loss, net of tax |
|
| (928,814) | |
Total comprehensive loss |
|
| (13,251,523) |
The accompanying notes form an integral part of these consolidated financial statements.
F-50
Consolidated Statement of Members’ Equity
for the period from April 2, 2024 to December 31, 2024
| Accumulated | |||||||||||||
| Other |
| Total | |||||||||||
| Contributed |
| Additional |
| Comprehensive |
| Retained |
| Members’ | |||||
| Notes |
| capital |
| Paid-In Capital |
| Treasury units |
| income / (loss) |
| Earnings |
| Equity | |
Balance as of April 2 2024 |
|
| — |
| — |
| — |
| — |
| — | — | ||
Net loss for the period |
|
| — |
| — |
| — |
| — | (12,322,709) |
| (12,322,709) | ||
Remeasurement of retirement benefits obligation |
| 18 |
| — |
| — |
| — |
| (1,055,869) |
| — |
| (1,055,869) |
Foreign currency translation adjustment |
|
| — |
| — |
| — |
| 127,055 |
| — | 127,055 | ||
Contributions from: | ||||||||||||||
Syndicate of investors led by Perceptive Advisors |
|
| 36,400,000 |
| — |
| — |
| — |
| — |
| 36,400,000 | |
Addex Therapeutics |
| 12 |
| 10,400,000 |
| — |
| — |
| — |
| — |
| 10,400,000 |
Former Addex employees |
| 12 |
| 92,857 |
| — |
| — |
| — |
| — |
| 92,857 |
Class B units transferred to the Group |
| 13 |
| — |
| — |
| (371) |
| — |
| — |
| (371) |
Share-based compensation |
| 13 |
| — |
| 1,067,007 |
| — |
| — |
| — |
| 1,067,007 |
Balance as of December 31, 2024 |
| 46,892,857 |
| 1,067,007 |
| (371) |
| (928,814) |
| (12,322,709) |
| 34,707,970 |
The accompanying notes form an integral part of these consolidated financial statements.
F-51
Consolidated Statement of Cash Flows
for the period from April 2, 2024 to December 31, 2024
| Period from April 2, | |||
| 2024 to December 31, | |||
| 2024 | |||
| Notes |
| Amounts in USD | |
Cash flows from operating activities: | ||||
Net loss |
|
|
| (12,322,709) |
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
|
|
Service transaction agreement |
| 10 |
| (206,243) |
Depreciation |
| 8/15 |
| 28,775 |
Value of share-based services |
| 13 |
| 1,096,247 |
Post-employment benefits |
| 18 |
| (55,372) |
Foreign exchange differences |
|
|
| 231,468 |
Changes in operating assets and liabilities, net of effects of businesses acquired: |
|
|
|
|
Increase in accounts receivable, net |
| 6/10 |
| (74,617) |
Increase in other current assets |
| 6/10 |
| (153,930) |
Increase in prepaid expenses |
| 6/10 |
| (159,153) |
Increase in payables and accruals |
| 10/11 |
| 2,124,352 |
Decrease in other liabilities - related party |
| 10 |
| (145,203) |
Decrease in deferred income |
| 10 |
| (314,906) |
Net cash used in operating activities |
|
|
| (9,951,291) |
Cash flows used in investing activities |
|
|
|
|
Cash paid for business acquisitions |
| 10 |
| (5,509,035) |
Acquisition of property, plant, and equipment |
| 8 |
| (141,266) |
Cash balance of Neurosterix Pharma Sàrl on April 2, 2024 |
| 10 |
| 22,036 |
Net cash used in investing activities |
|
|
| (5,628,265) |
Cash flows from financing activities |
|
|
|
|
Proceeds from members’ contributions |
| 12 |
| 36,492,858 |
Net cash flows from financing activities |
|
|
| 36,492,858 |
Effect of exchange rate changes on cash, |
|
|
| (116,263) |
Cash, cash equivalents, and restricted cash: |
|
|
|
|
Net increase during the period |
|
|
| 20,797,039 |
Cash and cash equivalents as of April 2, 2024 |
|
|
| — |
Cash and cash equivalents at end of period |
| 5 |
| 20,797,039 |
During the period, the Company completed a business combination in which equity units with a fair value of USD 10.4 million were issued as non-cash consideration. Additionally, services valued at USD 0.2 million were provided without charge as part of the transaction. (see note 10).
The accompanying notes form an integral part of these consolidated financial statements.
F-52
Notes to the Consolidated Financial Statements
for the period from April 2, 2024 to December 31, 2024
(Amounts in USD)
1.General information
Neurosterix US Holdings LLC (the “Company”) and its subsidiaries (together, the “Group”) are a clinical stage biopharmaceutical company focused on development of allosteric modulators for the treatment of neurological disorders.
The Company was formed as a Delaware limited liability company on March 13, 2024, and is the parent company of Neurosterix Swiss Holdings AG. On April 2, 2024, the Group has been created as part of the acquisition of Neurosterix Pharma Sàrl by Neurosterix Swiss Holdings AG. The principal place of the Group is Chemin des Mines 9, CH 1202 Geneva, Switzerland.
For further discussion, see Note 12, Members’ Contribution
These consolidated financial statements have been approved for issuance by the Board of Directors on 15 May, 2025.
2.Summary of material accounting policies
The principal accounting policies applied in the preparation of these consolidated financial statements are set out below.
2.1 | Basis of preparation |
The accompanying consolidated financial statements and notes thereto have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”).
The preparation of financial statements requires the use of certain critical accounting estimates. It also requires management to exercise its judgment in the process of applying the Group's accounting policies. The areas involving a higher degree of judgment or complexity, or areas where assumptions and estimates are significant to the consolidated financial statements are disclosed in note 3 “Material accounting estimates and judgements”.
Due to rounding, numbers presented throughout these consolidated financial statements may not add up precisely to the totals provided. All ratios and variances are calculated using the underlying amount rather than the presented rounded amount.
2.2 | New Accounting Pronouncements |
New and amended standards adopted by the Group
A number of new or amended standards and interpretations became applicable for financial reporting periods beginning after December 13, 2023 such as ASU 2022-03, Fair Value Measurement (Topic 820) and ASU 2023-07, Segment Reporting (Topic 280). The management assessed that only the amendment related to the segment report was relevant for the Group but had no material impact on the financial statements.
New standards and interpretations not yet adopted by the Group
The Group is currently assessing the potential impacts of the various new and revised standards and interpretations that will be mandatory for financial reporting periods beginning after December 15, 2024, which the Group has not yet applied. Based on an analysis to date, the Group does not anticipate that these will have a material impact on the Group’s overall results and financial position. The Group is also assessing other new and revised standards which are not mandatory for financial reporting periods beginning after December 15, 2024 and noted that ASU 2023-09, Income Taxes (Topic 740) and ASU 2024-03, Income Statement - Reporting Comprehensive Income - Expense Disaggregation Disclosures (Subtopic 220-40) will be effective from the reporting periods beginning after December 15, 2024 and December 15, 2027 respectively.
F-53
2.3 | Consolidation |
The consolidated financial statements include the accounts of Neurosterix US Holdings LLC’s wholly owned subsidiaries and entities for which we have a controlling financial interest. All intercompany balances and transactions have been eliminated in consolidation.
When used in this report, the terms “the Group” and “the Company” mean Neurosterix US Holdings LLC and its subsidiaries. The Group assesses the terms of the investment interests to determine if all the subsidiaries meet the definition of a voting interest entity model (VOE model). A voting interest entity is defined as an entity that is not a Variable Interest Entity (VIE) that is a legal structure in which controlling interest is determined by something other than the majority voting rights. Based on the assessments of the Group under the applicable guidance, The Group did not have controlling financial interests in any VIEs and, therefore, all of the subsidiaries meet the definition of a VOE in 2024. As a consequence, the Group currently consolidates the financial operations of its two fully-owned subsidiaries: Neurosterix Swiss Holdings AG (formed in April 2024 and 100% owned during all the year 2024) and Neurosterix Pharma Sàrl (formed in March 2024 and 100% owned since April 2, 2024 following a spin-out of Addex Therapeutics).
The reporting date of all Group companies is December 31.
2.4 | Segment reporting |
The Group operates in one segment, which is the discovery, development and commercialization of small-molecule pharmaceutical products. A single management team that reports to the Chief Executive Officer comprehensively manages the entire business. The chief operating decision-maker is the board of Directors who review the statement of operations of the Group on a consolidated basis, makes decisions and manages the operations of the Group as a single operating segment. The Group’s activities are not affected by any significant seasonal effect. Revenue is attributable to Neurosterix Pharma Sàrl, company domiciliated in Switzerland.
2.5 | Foreign currency transactions |
We translate all assets and liabilities of foreign subsidiaries from the functional currency, which is generally the local currency, into U.S. dollars using the year-end exchange rate. We show the net effect of these translation adjustments within the consolidated financial statements as a component of Accumulated other comprehensive income (loss), net of tax. We translate revenues and expenses at the annual average exchange rate.
Foreign currency transaction gains and losses are included within non-operating results of the consolidated statements of operations.
2.6 | Property, plant and equipment |
We state property, plant, and equipment at historical cost. We charge expenditures for maintenance and repairs to expense and capitalize additions and improvements that extend the life of the underlying asset. We provide for depreciation using the straight-line method at rates that approximate the estimated useful lives of the assets. We depreciate computer equipment over a maximum life of three years; laboratory equipment over a maximum life of four years, and furniture and fixtures as well as chemical library over a maximum life of five years.
2.7 | Financial assets |
The Group has one category of financial assets, namely “Accounts receivable, net”. Account receivable net are non-derivative financial assets with fixed or determinable payments that are not quoted in an active market. These assets are held for collection of contractual cash flows which represent solely the payment of principal and interest. They arise when the Group provides money, goods or services directly to a debtor with no intention of trading the receivable. They are included in current assets, except for maturities greater than 12 months after the balance sheet date, which are classified as non-current assets. Trade and other receivables are included in other current assets in the balance sheet (see note 6). Accounts receivable net are initially measured at fair value and subsequently measured at amortized cost and are derecognized when settled.
F-54
Impairment of financial assets
The Group recognizes a loss allowance for current expected credit losses on account receivables net and security rental deposits that are measured at amortized cost. The amount of current expected credit losses is updated at each reporting date to reflect changes in credit risk since initial recognition of the respective financial instrument.
The Group always recognizes lifetime expected credit losses (“CECL”) for trade and other receivables where applicable. The CECL on these financial assets are estimated using a provision matrix based on the Group’s historical credit loss experience, adjusted for factors that are specific to the debtors, general economic conditions and an assessment of both the current as well as the forecast direction of conditions at the reporting date, including time value of money where appropriate.
Lifetime CECL represents the CECL that will result from all possible default events over the expected life of a financial instrument. In contrast, 12-month CECL represents the portion of lifetime CECL that is expected to result from default events on a financial instrument that are possible within 12 months after the reporting date.
2.8 | Cash and cash equivalents |
Cash and cash equivalents include deposits held at call with banks and other highly short-term investments with original maturities of three months or less. They are both readily convertible to known amounts of cash and so near their maturity that they present an insignificant risk of changes in value because of changes in interest rates.
2.9 | Contributed capital and additional paid-in capital |
Contributed capital is classified as member’s equity and represents the amounts invested by the holders of the Company for the issuance of units at the par value. Additional paid-in capital is classified as member’s equity and represents the amount invested by the holders of the Company for the issuance of units over the par value. Incremental costs directly attributable to the issue of new units are shown as a deduction, net of tax, from the proceeds.
Where any Group company purchases the Company's units (treasury units), the consideration paid, including any directly attributable incremental cost (net of income taxes) is recorded as a deduction from member’s equity as a treasury units reserve until the units are cancelled, reissued or disposed of. When such units are subsequently sold or reissued, any consideration received, net of any directly attributable incremental transaction costs and the related income tax effect, the nominal amount is reversed from the treasury unit reserve, with any remaining difference to the total transaction value being recognized in additional paid-in capital.
2.10 Equity instruments
Units issued by the Group are recorded at the fair value of the proceeds received, net of direct issuance costs.
2.11 Trade payables
Trade payables are recognized initially at fair value and subsequently measured at amortized cost using the effective interest method. All payables have a contract maturity within 1 year.
2.12 Grants
Grants are recognized when the conditions are substantially met. Grants are recognized as other income in the Statement of Operations on a systematic basis over the periods in which the Group recognizes as expenses the related costs for which the grant is intended to compensate. Specifically, grants whose primary conditions are that the Group should undertake specific research activities within a defined period of time, are recognized as deferred income or other current assets in the consolidated Balance Sheets and transferred to the Statement of Operations on a systematic and rationale basis over the defined timeframe.
F-55
2.13 Income taxes
The Company is classified as a partnership for federal and state income tax purposes. Therefore, federal and most state income taxes are assessed at the partner level.
Deferred income tax is recorded in full, using the liability method, on temporary differences arising between the tax bases of assets and liabilities and their carrying amounts in the consolidated financial statements. Deferred income tax is determined using tax rates and laws that have been enacted by the balance sheet date and are expected to apply when the related deferred income tax asset is realized, or the deferred income tax liability is settled.
All deferred tax assets are recognized and a valuation allowance is recognized to the extent that it is more likely than not that the deferred tax assets will not be realized.
2.14 Employee benefit plan obligation
The Group operates one Swiss pension scheme accounted in accordance with ASC 715-30 for the employees of Neurosterix Pharma Sàrl. The value of the pension obligations is determined using the Projected Unit Credit (PUC) method. This method sees each period of service as giving rise to an additional unit of benefit entitlements/employee benefits. The value of the employee benefit obligations for active employees, or the Projected Benefit Obligation (PBO), on the reporting date is the same as the present value of the degree of entitlement existing on this date, in terms of future salary and pension increases and turnover rates. The valuation of pension obligations of pensioners is made on the basis of the present value of current pensions taking into account future increases in pensions. The service costs can be calculated on the basis of the PBO. They correspond to the present value of the entitlements to employee benefits earned during the year for which calculations are made.
Gains and losses comprise the actuarial gains and losses arising from changes in the economic and demographic assumptions, the actuarial gains and losses arising from unexpected changes in the population and gains and losses arising from changes in estimates of the market value of assets or differences between actual and anticipated returns.
2.15 Share-based compensation
The Group operates an equity incentive plan, which allows to grant to present and future employees, officers, directors, managers and/or other service providers of the Company a number of incentive units class B. The fair value of the services received in exchange for the grant is recognized in the consolidated financial statements over the period for which the services are received. The total amount to be recognized over the vesting period is determined by reference to the fair value of the equity incentive unit granted or transferred. The proceeds received net of any directly attributable transaction costs are credited to contributed capital (nominal value) and the difference with the fair value in Additional paid in capital.
2.16 Leases
The Group has operating leases for real estate including corporate offices and laboratory spaces, parking places and certain IT equipment.
Leases with an initial term of 12 months or less are generally not recorded on the balance sheet, unless the arrangement includes an option to purchase the underlying asset, or an option to renew the arrangement, that the Group is reasonably certain to exercise (short-term leases). In addition, the Company has elected not to separate non-lease components from the lease components. The Group recognizes lease expense on a straight-line basis over the lease term for short-term leases that the Group does not record on the balance sheet. If there is a change in the assessment of the Group related to the lease term and, as a result, the remaining lease term extends more than 12 months from the end of the previously determined lease term, or the Group subsequently becomes reasonably certain that it will exercise an option to purchase the underlying asset, the lease no longer meets the definition of a short-term lease and is accounted for as either an operating or finance lease and recognized on the balance sheet.
F-56
The Group determines whether an arrangement is or contains a lease based on the unique facts and circumstances present at the inception of the arrangement. Operating lease liabilities and their corresponding right-of-use assets are recorded based on the present value of lease payments over the expected lease term. The interest rate implicit in lease contracts is typically not readily determinable. As such, the Group utilizes the appropriate incremental borrowing rate, which is the rate incurred to borrow on a collateralized basis over a similar term at an amount equal to the lease payments in a similar economic environment. Certain adjustments to the right-of-use asset may be required for items such as initial direct costs paid or incentives received.
The leases are depreciated over the shorter period of lease term and useful life of the underlying asset. If a lease transfers ownership of the underlying asset or the cost of the right-of-use asset reflects that the Group expects to exercise a purchase option, the related right-of-use asset is depreciated over the useful life of the underlying asset. The depreciation starts at the commencement date of the lease.
The right-of-use assets and corresponding liabilities are presented as a separate line in the consolidated Balance Sheet.
All lease payments are presented as part of the cash flow under operating activities.
2.17 Research and development
Research and development costs are expensed as incurred. Costs incurred on development projects are recognized as intangible assets only for expenditures on materials, equipment, and facilities that are acquired or constructed for Research and development activities and that have an alternative future use.
In the opinion of management, due to uncertainties inherent in the development of the Group’s products, the criteria for development costs to be recognized as an asset, as prescribed by ASC 730, “Research and Development”, are not met.
2.18 Valuation of Business Combinations
The Group allocates the amounts paid for the acquisition of Neurosterix Pharma Sàrl on April 2, 2024 to the acquired assets and assumed liabilities based on their fair values at the date of acquisition, including identifiable research and development intangible assets. The group assesses the fair value of identifiable research and development intangible assets acquired in a business combination using detailed financial valuations based on information and assumptions provided by management considered as best estimates of inputs and assumptions. The Group allocates to goodwill any excess purchase price over the fair value of acquired net tangible and intangible assets including the research and development intangible assets and goodwill. Transaction costs associated with the acquisition of Neurosterix Pharma Sàrl are expensed as incurred through general and administrative expenses.
2.19 Valuation of development supplies and consumables
The supplies and consumables are recognized as an asset and valued at each periodic inventory at weighted average cost.
2.20 Deferred taxes
Deferred income tax is recorded in full, using the liability method, on temporary differences arising between the tax bases of assets and liabilities and their carrying amounts in the consolidated financial statements. However, if the deferred income tax arises from initial recognition of an asset or liability in a transaction other than a business combination that at the time of the transaction affects neither accounting nor taxable profit or loss, it is not accounted for. Deferred income tax is determined using tax rates and laws that have been enacted or substantively enacted by the balance sheet date and are expected to apply when the related deferred income tax asset is realized, or the deferred income tax liability is settled.
Deferred income tax assets are recognized to the extent that it is probable that future taxable profit will be available against which the temporary differences can be utilized.
Deferred income tax is recorded on temporary differences arising on investments in subsidiaries, except where the Group deems it probable that the temporary difference will not reverse in the foreseeable future. The temporary differences arising in investments accounted for using the equity method are recorded as deferred income taxes.
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Potential deferred income tax assets from tax loss carry forwards exceed deferred tax liabilities. Deferred income tax assets from tax loss carry forwards are initially recognized to the extent that the realization of the related tax benefit through future taxable profits is probable.
3.Material accounting estimates and judgments
The financial results are affected by the selection and application of accounting policies and methods. The Group adopted accounting policies to prepare the consolidated financial statements in conformity with U.S. GAAP.
To prepare the consolidated financial statements in accordance with U.S. GAAP, Management makes estimates and assumptions that may affect the reported amounts of the assets and liabilities, including the contingent liabilities, as of the date of the financial statements and the reported amounts of the revenues and expenses during the reporting periods. The actual results may differ from these estimates. The Group considers estimates to be critical (i) if it is required to make assumptions about material matters that are uncertain at the time of estimation or (ii) if materially different estimates could have been made or it is reasonably likely that the accounting estimate will change from period to period. The following are areas considered to be critical and require management’s judgment:
Grants
Grants are recorded at their fair value, and recognized as income when the conditions are substantially met. In certain circumstances, grant income may be recognized before explicit grantor acknowledgement that the conditions have been met.
Accrued research and development costs
The Group records accrued expenses for estimated costs of research and development activities conducted by third party service providers. The Group records accrued expenses for estimated costs of research and development activities based upon the estimated amount of services provided, but not yet invoiced, and these costs are included in accrued expenses on the balance sheets and within research and development expenses in the statements of Operations. These costs are a significant component of research and development expenses. Accrued expenses for these costs are recorded based on the estimated amount of work completed in accordance with agreements established with these third parties. Due to the nature of estimates, the Group may be required to make changes to the estimates after a reporting period as it becomes aware of additional information about the status or conduct of its research activities.
Valuation of research and development intangible assets
The Group assess the fair value of research and development intangible assets acquired in a business combination on detailed financial valuations that use information and assumptions provided by management considered as best estimates of inputs and assumptions. The use of alternative valuation assumptions, including estimated revenue projections, growth rates, cash flows, discount rates, and the probability of achieving clinical, regulatory, could result in different purchase price allocations.
The Group tests the indefinite-lived research and development intangible assets at least annually for impairment and reassess their classification as indefinite-lived assets, or more frequently if indicators exist. The Group assesses qualitative factors to determine whether the existence of events and circumstances indicate that it is more likely than not that the indefinite-lived research and development intangible assets are impaired. If the Group concludes that it is more likely than not that the research and development intangible asset is impaired, the Group then determines its fair value and performs the quantitative impairment test by comparing the fair value with the carrying value. If the carrying value exceeds the fair value of the indefinite-lived research and development intangible asset, the Group writes the carrying value down to fair value. The use of alternative valuation assumptions, including estimated revenue projections, growth rates, cash flows and discount rates could result in different fair value estimates. When the research and development assets are commercialized, they will be amortized over the remaining patent period.
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Goodwill valuation
The Group allocates any excess purchase price over the fair value of the net tangible and identifiable intangible assets acquired in a business combination to goodwill. The Group tests the goodwill balances, utilizing both qualitative and quantitative approaches described in FASB ASC 350, Intangibles - Goodwill and Other, annually for impairment, or more frequently if impairment indicators are present or changes in circumstances suggest an impairment may exist. The Group utilizes both qualitative (Step 0) and, when necessary, quantitative approaches (Step 1) as described in FASB ASC 350, Intangibles - Goodwill and Other. Changes in key valuation inputs or risk factors, such as significant revisions to discount rates or cash flow projections, are monitored to assess whether a quantitative test is warranted.
Going concern
The Group’s accounts are prepared on a going concern basis. The Group has financed its cash requirements from a committed funding of USD 65.0 million from a syndicate of investors led by Perceptive Advisors. Of these amount, USD 36.4 million was received in 2024, whilst the funding of the remaining amount of USD 28.6 million is subjected to the achievement of the scientific milestone that the Management assesses as likely to occur. The Group is a development-stage enterprise and is exposed to all the risks inherent in establishing a business. The Group expects that its existing and committed cash and cash equivalents, at the issuance date of these consolidated financial statements will be sufficient to fund its operations and meet all of its obligations as they fall due, up to the fourth quarter of 2026. The future viability of the Group is dependent on its ability to raise additional capital from public or private financings or collaboration agreements to finance its future operations, which may be delayed due to reasons outside of the Group’s control including health pandemics and geopolitical risks. The inability to obtain funding, as and when needed, would have a negative impact on the Group’s financial condition and ability to pursue its business strategies. If the Group is unable to obtain the required funding to run its operations and to develop and commercialize its product candidates, the Group could be forced to delay, reduce or stop some or all of its research and development programs to ensure it remains solvent.
Share-based compensation
The Group recognizes an expense for share-based compensation based on the valuation of equity incentive units. Additional information is disclosed in note 13.
Pension obligations
The present value of the pension obligations is calculated by an independent actuary and depends on a number of assumptions that are determined on an actuarial basis such as discount rates, future salary and pension increases, and mortality rates. Any changes in these assumptions will impact the carrying amount of pension obligations. The Group determines the appropriate discount rate at the end of each period. This is the interest rate that should be used to determine the present value of estimated future cash outflows expected to be required to settle the pension obligations. In determining the appropriate discount rate, the Group considers the interest rates of high-quality corporate bonds that are denominated in the currency in which the benefits will be paid, and that have terms to maturity approximating the terms of the related pension liability. This rate should correspond to bond yield of the Swiss Bond Indices Basket AA. Other key assumptions for pension obligations are based in part on current market conditions. Additional information is disclosed in note 18.
4.Segment information
In accordance with ASC 280, Segment Reporting, the Company’s chief operating decision makers, the board members, review the consolidated results when making decisions about allocating resources and assessing performance of the Company as a whole and hence, management has identified one single operating segment, related to the discovery, development and commercialization of small-molecule pharmaceutical products. The measure of segment assets is reported on the consolidated balance sheets as total consolidated assets. The revenue, costs and expenses, and the net income for the reportable segment are the same as those presented on the consolidated statements of operations and comprehensive loss.
Information about products, services and major customers
External income of the Group is derived from the business of discovery, development and commercialization of pharmaceutical products. Other revenue was related to grants earned from Innosuisse/Eurostars. For more detail, refer to note 14, “Other Income”.
F-59
Information about geographical areas
External income and long live assets are exclusively recorded in the Swiss operating company.
5.Cash and cash equivalents
| December 31, 2024 | |
Cash at bank |
| 20,797,039 |
Total cash and cash equivalents |
| 20,797,039 |
Split by currency:
| December 31, 2024 |
| |
USD |
| 98.26 | % |
CHF |
| 1.55 | % |
EUR |
| 0.16 | % |
GBP |
| 0.03 | % |
Total |
| 100.00 | % |
Credit quality of cash and cash equivalents
The banks consist of Swiss banks whose credit rating is A-1 according to Standard & Poor’s.
6.Other current assets
| December 31, 2024 | |
Accounts receivable, net |
| 76,536 |
Prepaid expenses |
| 392,343 |
Other current assets |
| 206,034 |
Total other current assets |
| 674,913 |
The accounts receivable, net mainly relate to the VAT receivable for USD 31,501, to a credit note to be received from a supplier for USD 27,203 and to the grant from Eurostars/Innosuisse for USD 13,850 (See note 14 “other income” for further information related to the Eurostars/Innosuisse project). The Group applies the current expected credit loss (“CECL”) model under ASC 326 to measure expected credit losses for its trade receivables, and other receivables. This model uses a lifetime expected loss allowance for all trade receivables and other receivables upon initial recognition. The Group has considered that the trade receivables and other receivables have a low risk of default based on historic loss rates and forward-looking information on macroeconomic factors affecting the ability of the third parties to settle invoices. As a result, expected loss allowance has been deemed as nil as of December 31, 2024.
The other current assets comprise laboratory supplies and consumables for USD 153,776 and security rental deposits for USD 52,258.
7.Leases
Year ended December 31, 2024 |
| Total |
Opening net book amount as of March 18, 2024 |
| — |
Additions |
| 17,299 |
Variation during the year |
| (1,183) |
Closing net book amount |
| 16,116 |
F-60
At end of December 31, 2024, the Group recorded one operating lease related to an equipment (a printer) recognized in assets using a discounted rate of 1.09 %.The other operating leases related to the rents of the offices and laboratory spaces were not recorded as lease because the Group elected not to apply the lessee accounting model to leases with a lease term of 12 months or less, and recognized as operating costs for USD 260,263 (note 15) for the period from April 2, 2024 to December 31, 2024 . As of December 31, 2024, the Company did not have any finance leases.
A maturity analysis representing the future undiscounted cash flow of the Company’s operating leases liabilities as of December 31, 2024 is as follows:
| Total | |
2025 |
| 3,557 |
2026 |
| 3,557 |
2027 |
| 3,557 |
2028 |
| 3,557 |
2029 |
| 2,370 |
Total |
| 16,598 |
Discount factor |
| (482) |
Lease liability |
| 16,116 |
Amounts due within 12 months |
| 3,522 |
Non-current lease liability |
| 12,594 |
All payments of operating leases are classified as operating activities in the consolidated statement of cash flows and amounted to USD 258,057.
8.Property, plant and equipment
Year ended December 31, 2024 |
| Equipment |
| Furniture & fixtures |
| Chemical library |
| Total |
Opening net book amount as of April 2, 2024 |
| — |
| — |
| — |
| — |
Assets acquired from the acquisition of Neurosterix Pharma Sàrl |
| 20,920 |
| — |
| — |
| 20,920 |
Additions |
| 141,266 |
| — |
| — |
| 141,266 |
Depreciation charge |
| (28,775) |
| — |
| — |
| (28,775) |
Exchange differences |
| 768 |
| — |
| — |
| 768 |
Closing net book amount |
| 134,179 |
| — |
| — |
| 134,179 |
As of December 31, 2024 |
| Equipment |
| Furniture & fixtures |
| Chemical library |
| Total |
Cost |
| 1,663,986 |
| 8,012 |
| 1,330,063 |
| 3,002,061 |
Accumulated depreciation |
| (1,529,807) |
| (8,012) |
| (1,330,063) |
| (2,867,882) |
Net book value |
| 134,179 |
| — |
| — |
| 134,179 |
For the year ended December 31, 2024, the Group recorded a depreciation charge of USD 25,049 as part of research and development expenses and USD 3,726 as part of general and administration expenses. There was capital expenditure of USD 141,266 in 2024.
9.Goodwill and other intangible assets
The Group’s intangible assets amount to USD 18.36 million as of December 31, 2024 including USD 13.07 million related to indefinite-lived research and development intangible assets (note 3) transferred to the group on April 2, 2024 whose fair value has been based on the income approach and USD 5.29 million related to the remaining goodwill. The latter primarily relates to the knowledge of the employees transferred to the Group and includes a Deferred tax liabilities of USD 1.92 million related to the research and development intangible assets recorded in balance sheet in accordance with ASC 740 (note 17). As of December 31, 2024, the Group determined that the unpatented research and development intangible assets and the remaining goodwill were not impaired.
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The gross carrying amount of goodwill and other intangible assets and the related impairment charges are as follows:
Research and | ||||||
development | ||||||
Intangible | ||||||
Period from April 2 to December 31, 2024 |
| Goodwill (1) |
| assets |
| Total |
Opening net book amount as of April 2, 2024 |
| — |
| — |
| — |
Additions (note 10) |
| 5,287,591 |
| 13,070,823 |
| 18,358,414 |
Impairment and amortization charges |
| — |
| — |
| — |
Closing net book amount |
| 5,287,591 |
| 13,070,823 |
| 18,358,414 |
(1) | The Goodwill recorded as of December 31, 2024 includes the deferred tax liabilities of USD 1.92 million related to the Research and Development intangible assets. |
10.Business Combination
On April 2, 2024, the Group completed the acquisition of 100% of the outstanding equity of Neurosterix Pharma Sàrl and paid a cash consideration of CHF 5.0 million and 20% equity interest in Neurosterix US Holdings LLC issued to Addex Therapeutics. As part of the Transaction, the Group and Addex Therapeutics entered into a service agreement which provides to Addex Therapeutics with access to certain staff and infrastructure at zero cost to ensure the operation of the Addex Therapeutics retained business. The fair value of the service agreement amounted to USD 200,912 as of April 2, 2024.
The final purchase price of a part of the business of Addex Therapeutics comprised of the amount presented below in USD, converted at year-end exchange rate:
Consideration paid |
| December 31, 2024 |
Cash paid to Addex Therapeutics |
| 5,509,035 |
20% equity interest in Neurosterix US Holdings LLC (note 12) |
| 10,388,277 |
Fair value of the service agreement |
| 200,912 |
Total consideration |
| 16,098,224 |
The fair value of the 20% equity interest in Neurosterix US Holdings LLC has been assessed using a financial valuation method.
The purchase price has been allocated as follow :
| April 2, 2024 | |
Goodwill (note 9) |
| 5,287,591 |
Research and development Intangible assets (note 9) |
| 13,070,823 |
Total net assets acquired |
| (338,779) |
Deferred tax liabilities on research and development intangible assets |
| (1,921,411) |
Total |
| 16,098,224 |
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The following table is a summary of assets and liabilities transferred in connection with the acquisition at their respective fair values as of the acquisition date:
Assets transferred to Neurosterix Group |
| April 2, 2024 |
Cash |
| 22,036 |
Accounts receivable, net |
| 1,919 |
Prepaid expenses |
| 125,278 |
Laboratory supplies and consumables |
| 107,912 |
Security rental deposits |
| 52,104 |
Property, plant and equipment, net |
| 20,920 |
Surplus on pension obligation |
| 233,334 |
Total assets transferred to Neurosterix Group |
| 563,503 |
Liabilities transferred to Neurosterix Group |
|
|
Deferred income related to Innosuisse/Eurostars |
| 314,906 |
Payables and accruals |
| 433,394 |
Current account due to Addex Therapeutics |
| 153,982 |
Total liabilities transferred to Neurosterix Group |
| 902,282 |
Total net assets transferred to Neurosterix Group |
| (338,779) |
The following unaudited pro forma summary presents consolidated information of the Group as if the business combination had occurred at the beginning of the reporting period:
Pro-forma year | ||
ended December | ||
| 31, 2024 | |
Other income |
| 352,754 |
Net loss |
| (12,933,140) |
Neurosterix Pharma Sàrl incurred a net loss of USD 12.23 million since its acquisition by the Group on April 2, 2024.
11.Accounts payable and accrued expenses
| December 31, 2024 | |
Trade payables |
| 300,397 |
Social security and other taxes |
| 80,018 |
Accrued expenses |
| 2,177,331 |
Total accounts payable and accrued expenses |
| 2,557,746 |
The total payables and accruals amounted to USD 2.6 million for the year ended December 31, 2024. All payables mature within 3 months. Accrued expenses and trade payables primarily relate to R&D services from contract research organizations, consultants and professional fees. The carrying amounts of payables do not materially differ from their fair values, due to their short-term nature.
12.Members’ contributions
The units issued as of December 31, 2024 and the contributed amounts are as follow:
Contributed capital | ||||||
| Number |
| Funded |
| Unfunded | |
Class A units |
| 83,571,428.5714 |
| 46,800,000 |
| 28,600,000 |
Class B units |
| 9,285,714.2859 |
| 92,857 |
| — |
Balance as of December 31, 2024 |
| 92,857,142.8573 |
| 46,892,857 |
| 28,600,000 |
As of December 31, 2024, 92,857,142.8573 units were outstanding.
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The contributors of Neurosterix US Holdings LLC as of December 31, 2024 are as follow:
Contributed capital | ||||||
Number of units | ||||||
| Class A units |
| Class B units |
| Total | |
Syndicate of Investors led by Perceptive Advisors |
| 65,000,000.0000 |
| — |
| 65,000,000.0000 |
Addex Therapeutics |
| 18,571,428.5714 |
| — |
| 18,571,428.5714 |
Former Addex employees |
| — |
| 9,248,571.4288 |
| 9,248,571.4288 |
Re-purchase of units recorded as Treasury units |
| — |
| 37,142.8571 |
| 37,142.8571 |
Balance as of December 31, 2024 |
| 83,571,428.5714 |
| 9,285,714.2859 |
| 92,857,142.8573 |
The Company has two authorized classes of Units, consisting of Class A and Class B Units. Class A and B have the same voting rights, but Class A have additional rights related to the liquidation and distribution of dividends. All Class B Units shall be issued and awarded to employees, officers, directors, managers or other service providers of the Group (note 13).
As part of the funding executed on April 2, 2024, a syndicate of investors led by Perceptive Advisors received a total of 62,500,000 Class A units at a committed price of USD 1.00 per unit of which USD 0.56 was paid in April 2024 whilst the payment of the remaining committed amount of USD 0.44 per unit is subjected to the achievement of a scientific milestone event. At the same date, Addex Therapeutics received 17,857,142.86 Class A units as part of the consideration related to the divestment of a part of its business to Neurosterix Group which have been recognized at the fair value of USD 0.56 per unit and, following a Management equity plan, the former Addex employees received 8,928,572 Class B units paid USD 0.01 per unit (note 10).
On June 25, 2024, other investors introduced by Perceptive Advisors subscribed 2,500,000 Class A units at the same conditions as the funding executed on April 2, 2024 described in the paragraph above. At the same date, Addex Therapeutics freely received 714,285.7143 Class A units recognized at the fair value of USD 0.56 per unit whilst former Addex employees subscribed 357,142.2859 Class B units paid USD 0.01 per unit as planned in the Limited Liability company agreement of Neurosterix US Holdings LLC.
During the period from April 2, 2024 to December 31, 2024, the Group repurchased 37,142.8571 non-vested units to employees who left the Group in accordance with the Management incentive plan (more details are explained in note 13).
No distributions occurred during the year 2024.
13.Share-based compensation
In 2024, the Group granted to the former Executive Managers and employees of Addex transferred to Neurosterix Group a total of 9,285,714.2859 class B units at a purchase price of USD 0.01 per unit with vesting period over 4 years subject to the participant’s continued employment with the Group through the applicable vesting date. Of these class B units, 8,928,572.0000 were granted on April 2, 2024, and 357,142.2859 on June 25, 2024. Following the departure of an employee in May 2024 and in accordance with the Management equity incentive plan, 37,142.8571 class B units were re-purchased at the initial price of USD 0.01 per unit and transferred to the Group as treasury units and recorded USD 371 against the equity in the consolidated balance sheet as of end of December 31, 2024.
As of December 31, 2024, 9,248,571.4288 units Class B are outstanding of which 1,734,107.1429 are vested.
The valuation of the Class B units is based on the market approach relying of the funding executed on April 2, 2024 on which external investors paid Class A units at a price of USD 1.00 of which USD 0.56 immediately paid and USD 0.44 depending on the achievement of a scientific milestone event. As the fair value is estimated to USD 0.56 and the grant price is USD 0.01, the share-based compensation will amount to USD 0.55 per unit increased by the social charges.
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The total share-based compensation expense recognized in the statement of comprehensive profit or loss for equity incentive units granted has been recorded under the following headings:
| Period from April 2, 2024 | |
to December 31, 2024 | ||
Research and development |
| 485,386 |
General and administration |
| 610,861 |
Total share-based compensation |
| 1,096,247 |
As of December 31, 2024, the share-based compensation costs remaining to be recognized over the vesting period ending March 31, 2028 amounted to USD 4.8 million.
14.Other income
In September 2023, Addex Therapeutics was awarded a grant of CHF 0.5 million by Eurostars/Innosuisse to support the mGlu2NAM program of which CHF 0.3 million were received in December 2023. Under this agreement, it was required to complete specific research activities within a defined period of time. The funding was fixed and received based on the satisfactory completion of the agreed research activities and incurring the related costs.
On April 2, 2024, following the spin-out, the program was transferred to Neurosterix Pharma Sàrl (see note 10) for a remaining total amount of USD 314,906.
As of December 31, 2024 the Group recognized USD 337,765 in Other Income and USD 13,850 as other receivables in accordance to the grant conditions.
15.Operating expenses
| Period from April 2, 2024 | |
to December 31, 2024 | ||
Staff costs (note 16) |
| 4,676,669 |
Depreciation expenses (notes 8) |
| 28,775 |
Outsourced research and development expenses |
| 5,904,526 |
Laboratory consumables |
| 312,981 |
Patent maintenance and registration costs |
| 129,946 |
Short term operating lease |
| 260,263 |
Professional fees |
| 335,772 |
D&O insurance |
| 15,969 |
Other operating costs |
| 774,918 |
Total operating expenses |
| 12,439,819 |
The total operating costs is mainly driven by external research and development costs and staff costs (note 16). The total operating costs amounted to USD 12.4 million for the year ended December 31, 2024 including USD 5.9 million for outsourced research and development expenses and USD 4.7 million for staff costs.
16.Staff costs
| Period from April 2, 2024 | |
| to December 31, 2024 | |
Wages and salaries |
| 3,165,691 |
Service transition agreement (note 10) |
| (206,243) |
Social charges and insurances |
| 359,150 |
Value of share-based services (note 13) |
| 1,096,247 |
Retirement benefit (note 18) |
| 261,824 |
Total staff costs |
| 4,676,669 |
F-65
The total staff costs amounted to USD 4.7 million for the year ended December 31, 2024 including USD 3.2 million for wages and salaries and USD 1.1 million for the fair value of share-based compensation granted to executive managers and employees (note 13).
17.Taxes
The parent company Neurosterix US Holdings is classified as a partnership for federal and state income tax purposes. Therefore, federal and most state income taxes are assessed at the partner level. The other companies of the Group are domiciliated in Geneva and are subjected to a 14.70% income tax rate.
The significant components of the deferred income tax assets and liabilities are described below :
| December 31, 2024 | |
Deferred income tax assets |
|
|
Tax calculated at a rate of 14.70% for net operating losses of subsidiaries in Geneva |
| 1,739,700 |
Share-based compensation |
| 161,148 |
Valuation allowance for deferred income tax assets |
| (1,802,975) |
Total deferred income tax assets |
| 97,873 |
December 31, 2024 | ||
Deferred tax liabilities |
| |
Net loss incurred by Neurosterix Pharma Sarl from March 19, 2024 to April 1, 2024, before its acquisition by the Group | (89,733) | |
Other temporary differences | (8,140) | |
Total deferred tax liabilities to be offset on deferred income tax assets | (97,873) | |
Deferred tax liabilities on R&D intangible assets recorded in balance sheet | (1,921,411) |
The Group has decided not to recognize any deferred income tax assets at December 31, 2024. The key factors which have influenced management in coming to this evaluation are the fact that the Group has not yet a history of making profits due to the stage development of its drug products. As of December 31, 2024, the valuation allowance for deferred income tax assets amounted to USD 1,802,975 and the Group recorded in the balance sheet a deferred tax liability of USD 1,921,411 related to the Research and Development intangible assets, not recorded in the statutory financial statement of Neurosterix Swiss Holding, direct shareholder of the main operating company Neurosterix Pharma Sàrl purchased on April 2, 2024. In accordance with ASC 740, the deferred tax liabilities from Neurosterix Swiss Holdings have not been offset by the Deferred income tax from the main operating company Neurosterix Pharma Sàrl.
As of December 31, 2024, the tax carried forward related to the subsidiaries subjected to the income tax in Geneva amounted to USD 11.8 million and will expire on December 31, 2031.
18.Retirement benefit obligations
Apart from the social security plans fixed by the law, the Group sponsors an independent pension plan for the Swiss operational company. The Group has contracted with Swiss Life for the provision of occupational benefits. All benefits in accordance with the regulations are reinsured in their entirety with Swiss Life within the framework of the corresponding contract. This pension solution fully reinsures the risks of disability, death and longevity with Swiss Life. Swiss Life invests the vested pension capital and provides a 100% capital and interest guarantee. The pension plan is entitled to an annual bonus from Swiss Life comprising the effective savings, risk and cost results. Although, as is the case with many Swiss pension plans, the amount of ultimate pension benefit is not defined, certain legal obligations of the plan create constructive obligations on the employer to pay further contributions to fund an eventual deficit; this results in the plan nevertheless being accounted for as a defined benefit plan. All employees are covered by this plan, which is a defined benefit plan. Retirement benefits are based on contributions, computed as a percentage of salary, adjusted for the age of the employee and shared approximately 37% / 63% by employee and employer in 2024. In addition to retirement benefits, the plans provide death and long-term disability benefits to its employees. Liabilities and assets are revised every year by an independent actuary. Assets are held in the insurance company. In accordance with ASC 715-30, plan assets have been measured at fair value, and the projected benefit obligation has been determined using the “projected unit credit” method.
F-66
Employment benefit obligations
The amounts recognized in the balance sheet are determined as follows:
| December 31, 2024 | |
Defined benefit obligation |
| (9,256,992) |
Fair value of plan assets |
| 8,488,352 |
Shortfall on Funded status |
| (768,640) |
The shortfall on funded status amounted to USD 768,640 as of December 31, 2024.
The amounts recognized in the statement of comprehensive loss are as follows:
| Period from April 2, 2024 | |
| to December 31, 2024 | |
Employer service cost |
| (293,725) |
Other components of benefit cost |
| 31,901 |
Company pension cost |
| (261,824) |
The other components include interest costs for USD (85,272) and expected return on assets for USD 117,173.
The movements in the defined benefit obligations during the period from April 2, 20214 to December 31, 2024 converted at year-end exchange rate are as follows:
| 2024 | |
Defined benefit obligation on April 2, 2024 |
| — |
Business combination (note 10) |
| (7,632,011) |
Current service cost |
| (285,890) |
Interest cost |
| (82,998) |
Employee contributions |
| (180,892) |
Actuarial loss arising from changes in financial assumptions |
| (349,926) |
Actuarial loss on experience adjustment |
| (669,324) |
Benefits deposited (net) |
| (55,951) |
Defined benefit obligations at end of year |
| (9,256,992) |
The movements in the fair value of plan assets during the year are as follows:
| 2024 | |
Fair value of plan assets at beginning on April 2, 2024 |
| — |
Business combination (note 10) |
| 7,865,345 |
Actual return on plan asset |
| 77,429 |
Employee contributions |
| 180,892 |
Company contributions |
| 308,735 |
Benefits deposited (net) |
| 55,951 |
Fair value of plan assets at end of year |
| 8,488,352 |
As of the date of the preparation of these consolidated financial statements, the 2024 annual report of the pension fund has not yet been issued, and therefore the detailed structures and assets held at December 31, 2024, are not currently available for presentation.
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However, the detailed assets held at December 31, 2023, which were reported to the Group on May 13, 2024 by its plan administrator, are as follows:
| December 31, 2023 | ||
Cash | 0.40 | % | |
Bonds | 46.36 | % | |
Equity instruments | 14.02 | % | |
Real estate | 24.55 | % | |
Mortgages | 12.30 | % | |
Derivatives | 2.37 | % | |
Total | 100.00 | % |
The principal actuarial assumptions used were as follows:
| December 31, 2024 | ||
Discount rate |
| 1.00 | % |
Mortality tables |
| BVG2020 GT | |
Salary growth rate |
| 1.00 | % |
Pension growth rate |
| 0.00 | % |
The estimated employer contributions to pension plans for the financial year 2025 amount to USD 400,000.
The following table shows the components of the costs recognized in other comprehensive income:
| 2024 | |
Asset experience |
| (36,619) |
Actuarial loss on defined benefit obligation |
| (1,019,250) |
Total |
| (1,055,869) |
The following table shows the estimated benefit payments in CHF related to employee and employer contributions for the next ten years where the number of employees remains constant:
2025 |
| 268,000 |
2026 |
| 270,000 |
2027 |
| 271,000 |
2028 |
| 444,000 |
2029 |
| 351,000 |
2030-2034 |
| 3,441,000 |
19.Finance result, net
| Period from April 2, 2024 | |
| to December 31, 2024 | |
Interest income |
| 186 |
Interest cost |
| (248) |
Foreign exchange net loss |
| (220,593) |
Total finance result, net |
| (220,655) |
The finance result net is primarily driven by foreign exchanges differences on U.S Dollar cash deposits due to the evolution of the exchange rate of U.S Dollar compared to the Swiss franc. Finance result was a net loss of USD 0.2 million for the year ended December 31, 2024.
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20.Commitments and contingencies
Capital commitments
As at December 31, 2024, the Group has no contracted capital expenditure.
Contingencies
As part of the ordinary course of business, the Group is subject to contingent liabilities in respect of certain litigation. Currently, there is no outstanding litigation with a possible negative effect on the Group.
21.Related party transactions
Related parties include members of the Board of Directors, the Executive Management and principal owners of the Group. The following transactions were carried out with related parties:
Executive Management compensation
| Period from April 2, 2024 | |
| to December 31, 2024 | |
Salaries, other short-term employee benefits and post-employment benefits |
| 1,426,581 |
Share-based compensation |
| 913,540 |
Total |
| 2,340,121 |
Share-based compensation relates to the fair value of equity incentive units recognized through profit and loss following their vesting plan (See note 13).
No board fees have been paid during the year 2024.
On April 2, 2024, the Group completed the acquisition of 100% of the outstanding equity of Neurosterix Pharma Sàrl and paid a cash consideration of CHF 5.0 million and 20% equity interest in Neurosterix US Holdings LLC issued to Addex Therapeutics. As part of the Transaction, the Group and Addex Therapeutics entered into a service agreement which provides Addex with access to certain staff and infrastructure at zero cost to ensure the operation of the Addex Therapeutics retained business. The fair value of the service agreement amounted to USD 200,912 as of April 2, 2024. As of December 31, 2024, Neurosterix Group owed USD 8,778 to Addex Group.
22.Events after the balance sheet date
There were no material events between the balance sheet date and the date on which these financial statements were approved by the board of directors that would require adjustment to the financial statements or disclosure under this heading.
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