REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) or (g) OF THE SECURITIES EXCHANGE ACT OF 1934 |
ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
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☒ | Accelerated filer | ☐ | ||||
Non-accelerated file | ☐ | Emerging Growth Company |
U.S. GAAP ☐ |
by the International Accounting Standards Board ☒ |
Other ☐ |
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• | the initiation, timing, progress and results of our pre-clinical and clinical studies, and our research and development programs; |
• | our ability to advance product candidates into, and successfully complete, clinical studies; |
• | the timing of regulatory filings and the likelihood of favorable regulatory outcomes and approvals; |
• | regulatory developments in the United States and the European Union and its member countries, and other countries; |
• | the commercialization of our product candidates, if approved; |
• | the pricing and reimbursement of our product candidates, if approved; |
• | the regulatory qualification and certification of our in-house manufacturing facilities and their manufacturing capabilities and operations; |
• | our ability to contract on commercially reasonable terms with CROs, third-party suppliers of biological raw or starting materials and manufacturers; |
• | the implementation of our business model, strategic plans for our business, product candidates and technology; |
• | the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and technology; |
• | the ability of third parties with whom we contract to successfully conduct, supervise and monitor clinical studies for our therapeutic product candidates; |
• | estimates of our expenses, future revenues, capital requirements and our needs for additional financing; |
• | our ability to obtain additional funding for operations; |
• | the potential benefits of our strategic licensing agreements with strategic licensees and our ability to enter into future strategic arrangements; |
• | the ability and willingness of strategic licensees pursuant to our strategic licensing agreements with strategic licensees to actively pursue development activities under our collaboration agreements; |
• | our receipt of milestone or royalty payments pursuant to our strategic licensing agreements with Allogene Therapeutics, Inc. (“Allogene”) and Les Laboratoires Servier (“Servier”); |
• | our ability to maintain and establish collaborations or obtain additional grant funding; |
• | the rate and degree of market acceptance of, and demand for, our product candidates; |
• | our status as a passive foreign investment company for U.S. federal income tax purposes; |
• | the financial performance and cash runway for our Therapeutics business; |
• | our ability to attract and retain key scientific and management personnel; |
• | our expectations regarding the period during which we qualify as a foreign private issuer; |
• | developments relating to our competitors and our industry, including competing therapies and technologies; |
• | Calyxt’s future financial performance, including its cash runway, and statements about Calyxt’s ability to continue as a going concern and Calyxt’s management’s plans to address Calyxt’s liquidity and capital resource needs; |
• | Calyxt’s product pipeline and development; Calyxt’s business model and strategies for the development, commercialization and sales of its commercial products; commercial demand for Calyxt’s synthetic biology solutions; the development and deployment of Calyxt’s PlantSpring technology platform; Calyxt’s ability to deploy and leverage its artificial intelligence and |
machine learning (AIML) capabilities; the ability to scale production capability for Calyxt’s BioFactory production system; potential development agreements, partnerships, customer relationships, and licensing arrangements and their contribution to Calyxt’s financial results, cash usage, and growth strategies; and |
• | the potential impact of the COVID-19 pandemic on our business and operating results; and anticipated trends in our business. |
ITEM 1. |
IDENTITY OF DIRECTORS, SENIOR MANAGEMENT AND ADVISERS |
ITEM 2. |
OFFER STATISTICS AND EXPECTED TIMETABLE |
ITEM 3. |
KEY INFORMATION |
A. |
[Reserved] |
B. |
Capitalization and Indebtedness |
C. |
Reasons for the Offer and Use of Proceeds |
D. |
Risk Factors |
• | Our operating history, which has focused primarily on research and development and advancing immunotherapy gene-editing clinical trials, makes it difficult to assess our future prospects. |
• | We have not generated significant revenues and have incurred significant operating losses since our inception. While the amount of our future net losses will depend, in part, on the amount of our future operating expenses and our ability to obtain funding, realize payments under our strategic licensing arrangements, and obtain reimbursements of research tax credit claims, we anticipate that we will continue to incur significant losses for the foreseeable future. |
• | We face substantial competition in our discovery, development and commercialization activities from competitors who may have significantly greater resources than we do. |
• | Because our product candidates all apply novel gene-editing technology, we are heavily dependent on the successful development of this technology. |
• | The extent to which the COVID-19 pandemic and resulting deterioration of worldwide economic conditions adversely impacts our business, financial condition, and operating results will depend on future developments, which are difficult to predict. |
• | We may need to raise additional funding, which may not be available on acceptable terms or at all, and our ability to raise additional share capital is limited by French corporate law. |
• | Our product candidates must undergo clinical trials that are time-consuming and expensive, the outcomes of which are unpredictable, and for which there is a high risk of failure, and which are susceptible under a variety of circumstances to additional costs, delays, suspensions and terminations. |
• | Initial, interim and preliminary data from our clinical trials may change as more data becomes available, and subsequent data may not bear out promising early results. |
• | Because we anticipate that our product candidates will initially receive regulatory approval as treatments for advanced disease or rare diseases, the size of the initial market for our product candidates may be limited. |
• | Our manufacturing process, which is highly complex and heavily regulated, may be difficult to efficiently and effectively operate and scale to the level required for advanced clinical trials or commercialization. |
• | Our manufacturing facilities may not obtain or maintain the required regulatory authorizations to supply commercial products. |
• | Acceptance and adoption of gene-editing and enrollment in our trials may be adversely affected by undesirable side effects, negative perceptions among the public or the medical community, or the inadequacy of payor coverage. |
• | Our future profitability depends, in part, on our ability to penetrate global markets, where we would be subject to additional regulatory burdens and other risks and uncertainties. |
• | We rely on third parties for certain aspects of our discovery, development, manufacturing and commercialization, if any, of our product candidates and issues relating to such third parties, or their activities, which could result in additional costs and delays and hinder our research, development and commercialization prospects. |
• | Strategic license relationships may not be successful, including as a result of failures by our strategic licensees to perform satisfactorily or to devote resources to advance product candidates under our arrangements with them. |
• | We may encounter difficulties in managing our development and expansion, including challenges associated with recruiting additional employees, managing our internal development efforts and improving our operational, financial and management controls. |
• | The risk of product liability claims is inherent in the development and commercialization of therapeutic products, and product liability or other lawsuits could divert management and financial resources, result in substantial liabilities and reduce the commercial potential of our product candidates. |
• | The buy-out mechanism in our collaboration agreement with Servier may prevent or delay a takeover attempt. |
• | Our business is governed by a rigorous, complex and evolving regulatory framework, including premarketing regulatory requirements, pricing, reimbursement and cost-containment regulations, and rigorous ongoing regulation of approved products. This regulatory framework results in significant compliance costs, makes the development and approval of our product candidates time intensive and unpredictable, and may reduce the ultimate economic value and prospects for our product candidates. |
• | A Fast Track, Breakthrough Therapy or Regenerative Medicine Advanced Therapy designation by the U.S. Food and Drug Administration, or FDA, or a Priority Medicines designation by the European Medicines Agency, or EMA, may not lead to a faster development or regulatory review or approval process, and does not increase the likelihood that our product candidates will receive regulatory approval. |
• | Any regulatory compliance failures could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm and diminished profits and future earnings. |
• | Because our commercial success depends, in part, on obtaining and maintaining proprietary rights to our and our licensors’ intellectual property, our ability to compete may decline if we fail to obtain protection for our products, product candidates, processes and technologies or do not adequately protect our intellectual property. |
• | Our competitive position may be adversely impacted as a result of a variety of factors, including potentially adverse determinations of complex legal and factual questions involved in patents and patent applications or insufficiently long patent lifespans in one or more jurisdictions where we obtain intellectual property protection. |
• | Because it is cost prohibitive to seek intellectual property protection on a global basis, our intellectual property protection in certain jurisdictions many not be as robust as in the United States, which may adversely impact our competitive position. |
• | Third parties may assert rights to inventions we develop or otherwise regard as our own. |
• | A dispute concerning the infringement or misappropriation of our proprietary rights or the proprietary rights of others could be time consuming and costly, and an unfavorable outcome could harm our business. |
• | Our business could be harmed if we lose key management personnel or cannot attract and retain other qualified personnel. |
• | The rights of shareholders in companies subject to French corporate law differ in material respects from the rights of shareholders of corporations incorporated in the United States. |
• | Our By-laws and French corporate law contain provisions that may delay or discourage a takeover attempt. |
• | Our international operations may be exposed to foreign exchange risks, U.S. federal income tax risks, and additional risks, which may adversely affect our financial condition, results of operations and cash flows. |
• | If we are classified as a PFIC for 2022 or any future taxable year, there may be adverse U.S. federal income tax consequences to U.S. holders. |
• | As a foreign private issuer, we are exempt from a number of rules under the U.S. securities laws and the Nasdaq’s corporate governance standards. We expect to follow certain home country practices in relation to certain corporate governance matters, which may afford less protection than would be provided if we complied fully with the Nasdaq requirements. |
• | Holders of our ADSs do not directly hold our ordinary shares and may be subject to limitations on the transfer of their ADSs and certain voting and withdrawal rights of the underlying ordinary shares as well as limitations on their ability to exercise preferential subscription rights or receive share dividends. |
• | Share ownership is concentrated in the hands of our principal shareholders and management, who will continue to be able to exercise substantial influence. |
• | Calyxt’s ability to continue as a going concern will depend on its ability to obtain additional financing, which may not be available on acceptable terms or at all, and failure to obtain such financing may force Calyxt to delay, limit or terminate its operations. If financing is obtained through future equity offerings by Calyxt, we may experience substantial additional dilution and, in connection with our ownership level falling below 50%, we will lose certain rights under our stockholders agreement with Calyxt. |
• | Calyxt’s success depends on its ability to successfully deliver synthetic biology solutions, which will require significant resources in a highly competitive industry. Calyxt has limited operating history in this industry, and will faces challenges associated with allocating limited resources, raising capital. gaining customers and competing with companies with greater resources. |
• | For Calyxt to be successful, it must secure customer collaborations, efficiently price its offerings, and demonstrate its technical capabilities and ability for commercial scale production, which involves risks of failure inherent in the deployment of innovative and complex emerging technologies. |
• | As a result of our ownership level in Calyxt, we are exposed to the various other risks to which Calyxt is subject, including (i) additional business and operational risks associated with developing an emerging technology, Calyxt’s reliance on third parties for production and services, reliance on customers and licensees for development and commercialization efforts, and risks associated with outdoor agriculture; (ii) regulatory risks, including the navigation of ethical, legal and social concerns relating to genetically modified or edited plant cells, the complex and evolving regulatory framework, including uncertainty regarding foreign regulation, increasing regulation of hemp development activities, regulatory and compliance burdens under environmental, health and safety laws, (iii) intellectual property risks, including the corresponding risks described with respect to our intellectual property, and (iv) risk associated with attracting and maintaining key management personnel and protecting its data from cybersecurity attacks. |
• | Disruptions to, and delays in, the clinical trials for the product candidates that we are developing resulting from suspensions or delays in enrollment or difficulties in enrolling patients; increased patient withdrawals from, or restrictions imposed on, patients participating in, the clinical trials; diversion of healthcare resources away from the conduct of the clinical trials; or interruptions in data collection, monitoring and/or processing due to governmental restrictions imposed in response to the COVID-19 pandemic. |
• | Disruptions and delays to our research and development programs resulting from a shutdown of our laboratory facilities due to expanded governmental restrictions or illness among laboratory personnel as a result of COVID-19, increased absenteeism among scientific or laboratory employees, or delays with respect to raw material or starting material necessary for research and development activities. |
• | Delays with respect to operations at our manufacturing facilities resulting from increased, expanded or additional government restrictions in Paris, France or Raleigh, North Carolina, or as a result of supply chain disruptions affecting raw materials required for our manufacturing processes. |
• | Overall reduced operational productivity resulting from challenges associated with remote work arrangements, limited resources to employees, and increased cybersecurity risks as a result of remote access to our information systems. |
• | Constraints on financing opportunities resulting from dislocations in the capital markets, which may make it too costly or difficult for us to pursue public or private equity or debt financings on acceptable terms. |
• | conditions imposed by the FDA or any foreign regulatory authority regarding the scope or design of clinical trials; |
• | inability to generate sufficient preclinical, toxicology or other in vivo or in vitro data to support initiation of clinical studies; |
• | delays in obtaining, or the inability to obtain, regulatory agency approval for the conduct of the clinical trials or required approvals from institutional review boards, or IRBs, or other reviewing entities at clinical sites selected for participation in our clinical trials; |
• | the identification of flaws in the design of a clinical trial; |
• | changes in regulatory requirements and guidance that necessitate amendments to clinical trial protocols; |
• | delays in sufficiently developing, characterizing or controlling manufacturing processes suitable for clinical trials; |
• | insufficient supply or deficient quality of the product candidates or other materials necessary to conduct the clinical trials, including as a result of manufacturing issues at our in-house manufacturing facilities; ; |
• | difficulty in sourcing healthy donor material of sufficient quality and in sufficient quantity to meet our development needs; |
• | lower-than-anticipated enrollment and retention rate of subjects in clinical trials for a variety of reasons, including size of patient population, sites selection, nature of trial protocol, the availability of approved effective treatments for the relevant disease and competition from other clinical trial programs for similar indications and competition from approved products; |
• | delays in reaching agreement on acceptable terms with prospective contract research organizations (CROs) and clinical study sites and obtaining required institutional review board (IRB) approval at each clinical study site; |
• | the placing of a clinical hold on our strategic licensees’ clinical trials—for example, clinical holds were placed on our AMELI-01 Study in September 2018 and on our MELANI-01 Study in July 2020 and on all of our strategic licensee Allogene’s AlloCAR T clinical trials in October 2021 and remained in place until the FDA permitted these trials to restart in November 2018, November 2020 and January 2022, respectively; |
• | unfavorable interpretations by FDA or similar foreign regulatory authorities of interim data; |
• | determinations by the FDA or similar foreign regulatory authorities that a clinical trial protocol is deficient in design to meet its stated objectives; |
• | failure to conduct the clinical trial in accordance with regulatory requirements or our clinical protocols; |
• | serious and unexpected safety issues, including drug-related side effects experienced by patients in clinical trials; |
• | failure of our or our strategic licensees’ third-party contractors to meet their contractual obligations in a timely manner; or |
• | lack of, or failure to, demonstrate efficacy of our products candidate. |
• | severity of the disease under investigation; |
• | incidence and prevalence of the disease under investigation; |
• | design of the clinical trial protocol; |
• | size and nature of the patient population; |
• | eligibility criteria for the trial in question; |
• | perceived risks and benefits of the product candidate under trial, including relative to other available therapies; |
• | proximity and availability of clinical trial sites for prospective patients; |
• | availability of competing therapies and clinical trials; |
• | patient referral practices of physicians; |
• | our ability to monitor patients adequately during and after treatment, and |
• | ability of the clinical sites to have sufficient resources and avoid any backlogs. |
• | failing to receive regulatory approvals required to market them as drugs; |
• | being subject to proprietary rights held by others; |
• | failing to comply with GMP requirements; |
• | being difficult or expensive to manufacture on a commercial scale; |
• | having adverse side effects that make their use less desirable; |
• | being inferior to existing approved drugs or therapies; |
• | failing to compete effectively with existing or new products or treatments commercialized by competitors; or |
• | failing to show long-term benefits sufficient to offset associated risks. |
• | the clinical indications for which product candidates are approved; |
• | the potential and perceived advantages and risks of our product candidates relative to alternative treatments; |
• | the prevalence and severity of side effects; |
• | the demonstration of the clinical efficacy and safety of the product; |
• | the approved labeling for the product and any required limitations or warnings; |
• | the timing of market introduction of the product candidate as well as of competing products; |
• | the effectiveness of educational outreach to the medical community about the product; |
• | the coverage and reimbursement policies of government and commercial third-party payors pertaining to the product; and |
• | the market price of the product relative to competing treatments. |
• | a covered benefit under applicable policies or plans; |
• | safe, effective and medically necessary; |
• | appropriate for the specific patient; |
• | cost-effective; and |
• | neither experimental nor investigational. |
• | obtaining, on a country-by-country |
• | the burden of complying with complex and changing regulatory, tax, accounting and legal requirements in each jurisdiction that we pursue; |
• | differing medical practices and customs affecting acceptance in the marketplace; |
• | import or export licensing requirements; |
• | country specific requirements related to the cells used as starting material for manufacturing; |
• | language barriers for technical training, healthcare professionals and patients documents; |
• | reduced protection of intellectual property rights in some foreign countries; |
• | foreign currency exchange rate fluctuations; |
• | potential imposition of governmental controls; and |
• | patients’ ability to obtain reimbursement for products in various markets. |
• | that we may be unable to negotiate agreements with third parties under reasonable terms or that termination or non-renewal of an agreement occurs in a manner or time that is costly or damaging to us; |
• | that such third-parties may have limited experience with our or comparable products and may require significant support from us in order to implement and maintain the infrastructure and processes required to manufacture, test or distribute our product candidates; |
• | that such third parties may not perform as agreed or in compliance with applicable laws and requirements, or may not devote sufficient resources to our products; |
• | that we may not have sufficient rights or access to the intellectual property or know how relating to improvements or developments made by our third-party service providers in the course of their providing services to us; |
• | that regulators object to or disallow the performance of specific tasks by certain third parties or disallow data provided by such third parties; |
• | that such third parties may experience business disruptions, such as bankruptcy or acquisition, or failures or deficiencies in their supply chains, that disrupt their ability to perform their obligations to us. |
• | strategic licensees may not perform or prioritize their obligations as expected; |
• | clinical trials conducted pursuant to strategic licensing agreements may not be successful; |
• | strategic licensees may not pursue development and commercialization of product candidates that achieve regulatory approval or may elect not to pursue development or commercialization of product candidates based on clinical trial results, changes in the partners’ focus or available funding, or external factors, such as an acquisition, that divert resources or create competing priorities; |
• | strategic licensees may delay clinical trials, provide insufficient funding for clinical trials, stop a clinical trial, or abandon a product candidate; |
• | strategic licensees could develop, independently or with third parties, products that compete directly or indirectly with our product candidates; |
• | product candidates developed pursuant to strategic licensing agreements may be viewed by our partners as competitive with their independently developed product candidates or products, which may cause them to devote limited resources to the product candidate’s development or commercialization; |
• | a collaborator may not commit sufficient resources to the commercialization, marketing and distribution of any product candidate; |
• | disagreements with strategic licensees, including over proprietary rights, contract interpretation, or the preferred course of development, may cause delays or termination of the development or commercialization of such product candidates, or may result in time- consuming and expensive legal proceedings; |
• | strategic licensees may not properly obtain, maintain, protect, defend or enforce intellectual property rights or may improperly use proprietary information; |
• | disputes may arise with respect to the ownership of intellectual property developed pursuant to our strategic licensing agreements; |
• | strategic licensees may infringe, misappropriate or otherwise violate third-party intellectual property rights, which may expose us to litigation and potential liability; |
• | strategic licensing agreements may be terminated for convenience by the collaborator and, if terminated, the development of product candidates may be delayed or stopped; |
• | the negotiation of strategic licensing agreements may require substantial attention from our management team; and |
• | we could face significant competition in seeking appropriate strategic licensees, and the negotiation process is time-consuming and complex. |
• | our inability to exercise direct control over sales, distribution and marketing activities and personnel; |
• | potential failure or inability of contracted sales personnel to successfully market our products to physicians; |
• | potential disputes with third parties concerning distribution, sales and marketing expenses, calculation of royalties, and sales and marketing strategies. |
• | identifying, recruiting, integrating, maintaining and motivating additional employees; |
• | effectively managing our internal development efforts, including the clinical and regulatory review process for our product candidates; and |
• | improving our operational, financial and management controls, reporting systems and procedures. |
• | issue a warning letter asserting a violation of the law; |
• | seek an injunction or impose civil or criminal penalties or monetary fines; |
• | suspend or withdraw regulatory approval; |
• | suspend or terminate any ongoing clinical trials; |
• | refuse to approve a pending BLA or comparable foreign marketing application (or any supplements thereto) submitted by us or our strategic licensees; |
• | restrict the marketing, distribution or manufacturing of the product; |
• | seize or detain product or otherwise require the withdrawal or recall of product from the market; |
• | destroy or require destruction of products; |
• | refuse to permit the import or export of products; or |
• | refuse to allow us to enter into supply contracts, including government contracts. |
• | their biological medicine is highly similar to the reference medicine, notwithstanding natural variability inherent to all biological medicines; and |
• | there are no clinically meaningful differences between the biosimilar and the reference medicine in terms of safety, quality and efficacy. |
• | the second applicant can establish that its product, although similar to the orphan medicinal product already authorized, is safer, more effective or otherwise clinically superior; |
• | the holder of the marketing authorization of the orphan medicinal product consents to a second orphan medicinal product application; or |
• | the holder of the marketing authorization of the orphan medicinal product cannot supply sufficient quantities of the orphan medicinal product. |
• | The federal Anti-Kickback Statute, which prohibits, among other things, persons from knowingly and willfully soliciting, offering, receiving or providing remuneration (including any kickback, bribe or rebate), directly or indirectly, in cash or in kind, to induce or reward either the referral of an individual for, or the purchase or lease, order or recommendation of, any item, good, facility or service, for which payment may be made under federal healthcare programs such as Medicare and Medicaid. |
• | The federal civil and criminal false claims laws and civil monetary penalties laws, which impose criminal and civil penalties, including those from civil whistleblower or qui tam actions, against individuals or entities for knowingly presenting, or causing to be presented, claims for payment that are false or fraudulent or making a false statement to avoid, decrease, or conceal an obligation to pay money to the federal government. |
• | The federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, which created new federal criminal statutes that prohibit executing a scheme to defraud any healthcare benefit program or knowingly and willingly falsifying, concealing or covering up a material fact or making false statements relating to healthcare matters. |
• | HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, or HITECH, and its implementing regulations, which impose certain requirements on covered entities and their business associates, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually identifiable health information. |
• | The federal transparency requirements under the Physician Payments Sunshine Act, enacted as part of the ACA, that require applicable manufacturers of covered drugs, devices, biologics and medical supplies to track and annually report to CMS payments and other transfers of value provided to physicians and teaching hospitals and certain ownership and investment interests held by physicians or their immediate family members. |
• | Analogous laws and regulations in various U.S. states, such as state anti-kickback and false claims laws, which may apply to items or services reimbursed by any third-party payor, including commercial insurers, state marketing and/or transparency laws applicable to manufacturers that may be broader in scope than U.S. federal requirements, state laws that require biopharmaceutical companies to comply with the biopharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the U.S. government, and state laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and may not have the same effect as HIPAA. |
• | the right to nominate a number of designees for Calyxt’s board of directors representing a majority of the directors, to designate the Chairman of the board of directors and to have at least one designated director serve on each board committee; |
• | information rights with respect to Calyxt; |
• | approval of certain changes to Calyxt’s constitutive documents; |
• | approval of Calyxt’s making of any regular or special dividends; |
• | approval of Calyxt’s commencement of any voluntary bankruptcy proceeding or any consent to any bankruptcy proceeding; |
• | approval of any appointment to or removal from the Calyxt board of directors; and |
• | approval of the consummation of any public or private offering, merger, amalgamation or consolidation of Calyxt, the spinoff of a business of Calyxt, or any sale, conveyance, transfer or other disposition of Calyxt’s assets. |
• | Adverse weather conditions, natural disasters, crop disease, pests and other natural conditions; |
• | Climate change that may cause changes in weather patterns and conditions, including changes in rainfall and storm patterns and intensities, water shortages, changes in sea levels, and changes in temperature levels; |
• | Licensee field trials may be unsuccessful; |
• | Licensee products, and food containing those products, may fail to meet standards established by third-party non-GMO verification organizations; |
• | The unintended presence of Calyxt’s traits in other products or plants may have a negative effect on the licensee’s operations. |
• | a failure to achieve commercial traction with Calyxt’s target customers; |
• | loss of customer contracts or delays in fulfilling Calyxt’s contractual obligations; |
• | damage to Calyxt’s brand reputation; |
• | product recalls or replacements; |
• | inability to attract new customers and collaboration opportunities; |
• | diversion of resources from Calyxt’s R&D and sales activities; and |
• | legal and regulatory claims against Calyxt, including product liability claims, which could be costly, time consuming to defend, result in substantial damages and result in reputational damage. |
• | we or our licensors may not have been the first to invent the technology covered by our or their pending patent applications or issued patents; |
• | we cannot be certain that we or our licensors were the first to file patent applications covering our product candidates, including their compositions or methods of use, as patent applications in the United States and most other countries are confidential for a period of time after filing; |
• | others may independently develop identical, similar or alternative products or compositions or methods of use thereof; |
• | the disclosures in our or our licensors’ patent applications may not be sufficient to meet the statutory requirements for patentability and the plausibility case law requirements that may exist in certain jurisdictions; |
• | any or all of our or our licensors’ pending patent applications may not result in issued patents; |
• | we or our licensors may not seek or obtain patent protection in countries or jurisdictions that may eventually provide us a significant business opportunity; |
• | any patents issued to us or our licensors may not provide a basis for commercially viable products, may not provide any competitive advantages, or may be successfully challenged by third parties, which may result in our or our licensors’ patent claims being narrowed, invalidated or held unenforceable; |
• | our compositions and methods may not be patentable; |
• | others may design around our or our licensors’ patent claims to produce competitive products that fall outside of the scope of our or our licensors’ patents; and |
• | others may identify prior art or other bases upon which to challenge and ultimately invalidate our or our licensors’ patents or otherwise render them unenforceable. |
• | payment of damages, potentially including treble or punitive damages if we are found to have willfully infringed a party’s patent rights; |
• | injunctive or other equitable relief that may effectively block our ability to further develop, commercialize, and sell products; |
• | our or our collaborators being required to obtain a license under third-party intellectual property, and such license may not be available on an exclusive basis, on commercially acceptable terms, or at all; or |
• | extensive discovery in which our confidential information could be compromised. |
• | the scope of rights granted under the license agreement and other interpretation-related issues; |
• | the basis of royalties and other consideration due to our licensors; |
• | the extent to which our products, product candidates, technology and processes infringe on intellectual property of the licensor that is not subject to the licensing agreement; |
• | the sublicensing of patent and other rights under our collaborative development relationships; |
• | our diligence obligations under the license agreement and what activities satisfy those diligence obligations; |
• | the ownership of inventions and know-how resulting from the joint creation or use of intellectual property by our licensors and us and our partners; and |
• | the priority of invention of patented technology. |
• | a merger (i.e., in a French law context, a stock-for-stock two-thirds majority of the votes cast of the shareholders present, represented by proxy or voting by mail at the relevant meeting; |
• | a merger of our company into a company incorporated outside of the European Union would require the unanimous approval of our shareholders; |
• | under French law, a cash merger is treated as a share purchase and would require the consent of each participating shareholder; |
• | our shareholders have granted and may in the future grant to our board of directors broad authorizations to increase our share capital or to issue additional ordinary shares or other securities (for example, warrants) to our shareholders, the public or qualified investors, which could be used as a possible defense following the launching of a tender offer for our shares; |
• | our shareholders have preferential subscription rights proportional to their shareholding in our company on the issuance by us of any additional shares or securities giving the right, immediately or in the future, to new shares for cash or a set-off of cash debts, which rights may only be waived by the extraordinary general meeting (by a two-thirds majority vote) of our shareholders or on an individual basis by each shareholder; |
• | our board of directors has the right to appoint directors to fill a vacancy created by the resignation or death of a director, subject to the ratification by the shareholders of such appointment at the next shareholders’ meeting, which prevents shareholders from having the sole right to fill vacancies on our board of directors; |
• | our board of directors can only be convened by its chairman (and our managing director, if different from the chairman, may request the chairman to convene the board) or, when no board meeting has been held for more than two consecutive months, by directors representing at least one-third of the total number of directors; |
• | our board of directors meetings can only be regularly held if at least half of the directors attend either physically or by way of videoconference or teleconference enabling the directors’ identification and ensuring their effective participation in the board of directors’ decisions; |
• | our shares take the form of bearer securities or registered securities, if applicable legislation so permits, according to the shareholder’s choice. Issued shares are registered in individual accounts opened by us or any authorized intermediary (depending on the form of such shares), in the name of each shareholder and kept according to the terms and conditions laid down by the legal and regulatory provisions; |
• | under French law, a non-French resident as well as any French entity controlled by non-French residents may have to file a declaration for statistical purposes with the Bank of France (Banque de France) following the date of certain direct or indirect investments in us; see the section of this Annual Report titled “Ownership of Shares and ADSs by Non-French Persons”; |
• | approval of at least a majority of the votes cast of the shareholders present, represented by a proxy, or voting by mail at the relevant ordinary shareholders’ general meeting is required to remove directors with or without cause; |
• | advance notice is required for nominations to the board of directors or for proposing matters to be acted upon at a shareholders’ meeting, except that a vote to remove and replace a director can be proposed at any shareholders’ meeting without notice; |
• | transfers of shares shall comply with applicable insider trading rules; |
• | in the event where certain ownership thresholds would be crossed, a number of disclosures should be made by the relevant shareholder in addition to other certain obligations; see the section of this Annual Report titled “Declaration of Crossing of Ownership Thresholds”; and |
• | pursuant to French law, the sections of the By-laws relating to the number of directors and election and removal of a director from office may only be modified by a resolution adopted by a two-thirds majority of the votes cast of our shareholders present, represented by a proxy or voting by mail at the meeting. |
ITEM 4. |
INFORMATION ON THE COMPANY |
• | Autologous treatments must be specifically manufactured for each patient and the resulting engineered cells may have different properties due to significant patient-to-patient T-cells; |
• | Autologous treatments can bear high costs due to the necessity of producing a bespoke treatment for each patient and the effort consumed in modifying and growing each patient’s T-cells; and |
• | At this time, autologous treatments cannot be mass produced, may involve significant delay in production time if the number of patients exceeds the number of productions that can be made in parallel, and require patients be treated at select advanced facilities. |
• | Market access |
• | Cost-effectiveness and Scalable Manufacturing |
• | Novel Features |
• | Safety. T-cell receptor (TCR), which is responsible for T-cells’ non-self antigens; and |
• | Persistence |
• | Advance our self-owned allogeneic UCART portfolio |
• | Utilize our self-owned manufacturing network |
• | Structure a commercial launch plan |
• | Continue the research and development of our hematopoietic stem cells (HSC) platform |
1 | ALLO-501 and ALLO-501A are exclusively licensed to Servier and under a joint clinical development program between Servier and Allogene. The ALPHA and ALPHA2 studies targets Diffuse Large B-Cell Lymphoma (DLBCL) and Follicular Lymphoma (FL) indications, which are subtypes of NHL. |
2 | Phase 3 may not be required if Phase 2 is registrational. |
3 | ALLO-715 and ALLO-605 target BCMA which is a licensed target from Cellectis. ALLO-715 and ALLO-605 utilize TALEN® gene-editing technology pioneered and owned by Cellectis. Allogene has an exclusive license to the Cellectis technology for allogeneic products directed at the BCMA target. Allogene holds global development and commercial rights for this investigational candidate. |
4 | Allogene sponsored trial in combination with SpringWorks Therapeutics. |
5 | ALLO-316 targets CD70 which is a licensed target from Cellectis. ALLO-316 utilize TALEN® gene-editing technology pioneered and owned by Cellectis. Allogene has an exclusive license to the Cellectis technology for allogeneic products directed at the CD70 target. Allogene holds global development and commercial rights for this investigational candidate. |
• | In the extracellular space, one or more target binding domains, coming from ligands, such as antibodies or receptors, that can recognize their targets on the outside of the T-cell; |
• | A hinge that helps position the target binding domains relative to their targets; |
• | Trans-membrane domains that anchor the CAR at the T-cell’s surface relative to the T-cells; and |
• | A set of activating or signaling domains, which are located within the T-cell’s interior, that deliver appropriate signals to the T-cells leading to T-cell activation or repression according to the T-cell environment. Such signals may induce tumor cell killing, cytokine secretion and CAR T-cell multiplication. |
• | Market access |
• | Cost-effectiveness and Scalable Manufacturing |
• | Novel Features |
• | Safety. T-cell receptor (TCR), which is responsible for T-cells’ non-self antigens; |
• | Persistence |
• | Precision |
• | Specificity and Selectivity T-cell’s genome. |
• | Efficiency T-cells treated by TALEN to inactivate one gene bear the desired genomic modification. We believe TALEN’s high efficiency will be important to the cost-effectiveness of a manufacturing process involving the generation of gene-edited T-cells. |
• | Design – identify metabolic pathways to produce the target compound and the genes controlling these pathways, develop strategies for the optimized expression of the target genes, and design the technical approach to achieve the production of the targeted compound. A metabolic pathway is a linked series of chemical reactions occurring within a cell. The reactants, products, and intermediates of an enzymatic reaction are known as metabolites, which are modified by a sequence of chemical reactions catalyzed by enzymes. |
• | Engineer – direct changes in the plant cells using one or more genetic transformation and plant tissue culture techniques, and enhancements of genes in that plant species. |
• | Verify – use a combination of analytical tools to verify the compound produced against the customer’s specifications. The analytical tools used include natural product chemistry, metabolomics, genomics, gene expression tools, and other analytics. |
• | methods central to genome engineering and gene editing of blood cells, including gene targeting, replacement, insertions and/or knock-out by using TALE-nucleases; |
• | the main products we use in the manufacturing process, including nucleases; |
• | manufacturing steps, including cell electroporation, transformation and genetic modifications; |
• | resulting engineered cells; |
• | single-chain and multi-subunit CARs expressed at the surface of T-cells; |
• | specific gene inactivation and “suicide switch” gene expression; |
• | allogeneic and autologous treatment strategies using our T-cell products; and |
• | plant traits and methods for gene editing plant cells. |
• | the genetic editing of T-cells, using TALEN technology, covered by approximately twelve Cellectis-owned patent families and three in-licensed patent families; |
• | the insertion of transgenes into T-cells using electroporation of mRNA, covered by approximately five Cellectis-owned patent families; |
• | the appending of attributes to T-cells, covered by approximately eight Cellectis-owned patent families and one in-licensed patent family; |
• | the molecular structure of CARs, covered by approximately six Cellectis-owned patent families; and |
• | specific CARs that target selected antigen markers are covered by approximately fifteen Cellectis-owned patent applications and one in-licensed patent family. |
• | In August 2017, the FDA approved tisagenlecleucel (Kymriah ® ) from Novartis AG for the treatment of patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse. In May 2018, the FDA approved a label extension for Kymriah® for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy. Sales of Kymriah® were $76 million in 2018, $278 million in 2019, $474 million in 2020 and $587 million in 2021. In October 2021, the FDA accepted for priority review Novartis’ application for Kymriah® in adult patients with relapsed or refractory follicular lymphoma (FL) after two prior lines of treatment. |
• | In October 2017, the FDA approved axicabtagene ciloleucel (Yescarta ® ) commercialized by Kite Pharma, a subsidiary of Gilead Sciences, for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy. Sales of Yescarta® were $264 million in 2018, $456 million in 2019, $563 million in 2020 and $695 million in 2021. In April 2021, the FDA approved Yescarta® forthe treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy. |
• | In July 2020, the FDA approved brexucabtagene autoleucel (Tecartus ™ ) commercialized by Kite Pharma, a subsidiary of Gilead Sciences, for the treatment of adult patients with relapsed or refractory mantle cell lymphoma. In October 2021, the FDA approved Tecartus™ for the treatment of adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia. |
• | In December 2020, Janssen began a rolling submission of a Biologics License Application, or BLA for the anti-BCMA CAR-T cell therapy ciltacabtagene autoleucel (cilta-cel) in relapsed or refractory multiple myeloma (formerly known as LCAR-B38M and in partnership with Legend Biotech). |
• | In February 2021, the FDA approved idecabtagene vicleucel (Breyanzi ™ ) commercialized by Bristol Myers Squibb and bluebird bio for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy. |
• | In March 2021, FDA approved idecabtagene vicleucel (Abecma ™ ) commercialized by Bristol Myers Squibb and bluebird bio, for the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody. |
• | Autologous and Allogeneic CAR T-cell space: Juno Therapeutics, Inc. (in collaboration with Editas Medicine Inc.), acquired by Celgene Corporation and acquired since by Bristol-Myers Squibb; Bluebird bio, Inc. (in collaboration with Celgene Corporation, acquired since by Bristol-Myers Squibb), Ziopharm Oncology Inc. (in collaboration with Intrexon Corporation), Kite Pharma Inc. (in collaboration with Amgen Inc. and with Sangamo Therapeutics Inc.), acquired by Gilead Sciences Inc., Novartis AG (in collaboration with Intellia Inc.), Johnson & Johnson (in collaboration with Transposagen Biopharmaceuticals Inc.), Precision Biosciences (in collaboration with Servier), Regeneron Pharmaceuticals Inc. (in collaboration with Adicet Bio Inc), Fate Therapeutics Inc. (in collaboration with Janssen), CRISPR Therapeutics Inc., Takeda Pharmaceutical Company Limited, Tmunity Therapeutics Inc., Mustang Bio, Atara Biotherapeutics Inc., (in collaboration with Bayer), Adaptimmune (in collaboration with Astellas), Poseida Therapeutics Inc., BioNTech SE, Vor Therapeutics Inc., Autolus Therapeutics plc., Bellicum Pharmaceuticals, Inc., and Celyad S.A. |
• | Gene-editing space: CRISPR Therapeutics Inc. (in collaboration with Bayer AG and Vertex Inc.), Editas Medicine, Inc. (partnered with Allergan and Celgene), Intellia Therapeutics, Inc. (partnered with Novartis), Precision BioSciences, Inc., Sangamo BioSciences, Inc. (partnered with Kite/Gilead and Pfizer), Vertex/Exonics Therapeutics (partnered with CRISPR Therapeutics), Graphite Bio Inc. and Beam Therapeutics Inc.. |
• | Cell-therapy space: Adaptimmune Ltd, Iovance Biotherapeutics, Unum Therapeutics, Inc., NantKwest, Inc., Cytovia Therapeutics, Inc., Atara Biotherapeutics, Inc., and Immunocore Ltd. |
• | completion of extensive nonclinical, sometimes referred to as pre-clinical laboratory tests, pre-clinical animal studies and formulation studies in accordance with applicable regulations, including the FDA’s GLP regulations; |
• | production and testing of clinical products according to the current Good Manufacturing Practices, or cGMP, and possible FDA product specific requirements; |
• | submission to the FDA of an IND, which must become effective before clinical trials may begin and must be updated at least annually; |
• | performance of adequate and well-controlled clinical trials in accordance with applicable IND and other clinical trial-related regulations, sometimes referred to as Good Clinical Practices, or GCPs, to establish the safety and efficacy of the proposed product candidate for each proposed indication; |
• | submission to the FDA of a BLA; |
• | satisfactory completion of an FDA pre-approval inspection of the manufacturing facility or facilities where the active pharmaceutical ingredient, or API, and finished product are manufactured to assess compliance with the IND/BLA and FDA’s cGMP requirements to assure that the facilities, methods and controls are adequate to preserve the product’s identity, strength, quality, purity and potency; |
• | FDA review and approval of the BLA prior to any commercial marketing or sale of the product in the United States. |
• | Phase 1 pre-clinical testing warrants, the initial human testing may be conducted in patients with the condition of interest. |
• | Phase 2 |
• | Phase 3 |
• | the drug is a regenerative medicine therapy, which is defined as a cell therapy, therapeutic tissue engineering product, human cell and tissue product, or any combination product using such therapies or products, except for those regulated solely under Section 361 of the Public Health Service Act and part 1271 of Title 21, Code of Federal Regulations; |
• | the drug is intended to treat, modify, reverse, or cure a serious or life-threatening disease or condition; and |
• | preliminary clinical evidence indicates that the drug has the potential to address unmet medical needs for such disease or condition. |
• | 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; |
• | an increase in 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 a cap on the total rebate amount for innovator drugs at 100% of the Average Manufacturer Price, or AMP; |
• | a new Medicare Part D coverage gap discount program, in which manufacturers must agree to offer 50% point-of-sale |
• | extension of manufacturers’ Medicaid rebate liability to covered drugs dispensed to individuals who are enrolled in Medicaid managed care organizations; |
• | expansion of 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; |
• | expansion of the entities eligible for discounts under the Public Health Service pharmaceutical pricing program; and |
• | a new Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with funding for such research. |
• | The second applicant can establish that its product, although similar, is safer, more effective or otherwise clinically superior; |
• | The applicant consents to a second orphan medicinal product application; or |
• | The applicant cannot supply enough orphan medicinal product. |
C. |
Organizational Structure |
Group Structure as of December 31, 2021 | ||||
Subsidiary Name |
Jurisdiction of Incorporation |
Ownership & Voting Interest Held By Cellectis S.A. | ||
Calyxt, Inc. | Delaware | 61.8% (held directly) | ||
Cellectis, Inc. | Delaware | 100% (held directly) | ||
Cellectis Biologics, Inc. | Delaware | 100% (held indirectly through Cellectis, Inc.) |
D. |
Property, Plant and Equipment |
ITEM 4A. |
UNRESOLVED STAFF COMMENTS |
ITEM 5. |
OPERATING AND FINANCIAL REVIEW AND PROSPECTS |
For the year ended December 31, |
||||||||||||
2019 |
2020 |
2021 |
||||||||||
$ in thousands (except shares and per shares numbers) |
||||||||||||
Revenues and other income |
22,990 |
82,456 |
67,071 |
|||||||||
|
|
|
|
|
|
|||||||
Operating expenses |
||||||||||||
Cost of revenue |
(11,392 | ) | (36,275 | ) | (31,360 | ) | ||||||
Research and development expenses |
(92,042 | ) | (86,950 | ) | (129,030 | ) | ||||||
Selling, general and administrative expenses |
(43,017 | ) | (44,201 | ) | (37,869 | ) | ||||||
Other operating income and expenses |
(91 | ) | (467 | ) | 511 | |||||||
|
|
|
|
|
|
|||||||
Operating income (loss) |
(123,552 |
) |
(85,437 |
) |
(130,677 |
) | ||||||
|
|
|
|
|
|
|||||||
Loss from discontinued operations |
— |
— |
||||||||||
Financial gain (loss) |
8,340 |
(12,046 |
) |
5,570 |
||||||||
|
|
|
|
|
|
|||||||
Net income (loss) |
(115,212 |
) |
(97,483 |
) |
(125,107 |
) | ||||||
|
|
|
|
|
|
|||||||
Attributable to shareholders of Cellectis |
(102,091 | ) | (81,074 | ) | (114,197 | ) | ||||||
Attributable to non-controlling interests |
(13,121 | ) | (16,409 | ) | (10,910 | ) | ||||||
Earnings per share attributable to shareholders of Cellectis (1) |
||||||||||||
Basic and diluted (2) |
(2.41 | ) | (1.91 | ) | (2.55 | ) | ||||||
Number of shares used for computing |
||||||||||||
Basic (1) |
42,442,136 | 42,503,447 | 44,820,279 | |||||||||
Diluted (1) |
42,442,136 | 42,503,447 | 44,820,279 | |||||||||
Other operating data |
||||||||||||
Adjusted Net Income (Loss) attributable to shareholders of Cellectis (3) |
(78,849 | ) | (66,709 | ) | (101,700 | ) |
(1) | See Note 17 to our consolidated financial statements for further details on the calculation of basic and diluted loss per ordinary share. |
(2) | Potential ordinary shares resulting from the exercise of share warrants and employee warrants are antidilutive. |
(3) | Adjusted Net Income (Loss) attributable to shareholders of Cellectis is not a measure calculated in accordance with IFRS. We define Adjusted Net Income (Loss) attributable to shareholders of Cellectis as our Net Income (Loss) attributable to shareholders of Cellectis, adjusted to eliminate the impact of Non-cash stock-based compensation expense. See “Note Regarding Use of Non-IFRS Financial Measures” for important information. Please refer below for a reconciliation of Adjusted Net Income (Loss) attributable to shareholders of Cellectis to Net Income (Loss) attributable to shareholders of Cellectis, which is the most directly comparable financial measure calculated in accordance with IFRS. |
As of December 31, |
||||||||||||
2019 (1) |
2020 |
2021 |
||||||||||
$ in thousands |
||||||||||||
Current financial assets and Cash and cash equivalents |
360,907 | 268,239 | 186,135 | |||||||||
Total assets |
467,469 | 469,471 | 382,075 | |||||||||
Total shareholders’ equity |
355,471 | 308,846 | 236,474 | |||||||||
Total non-current liabilities |
49,395 | 108,610 | 96,254 | |||||||||
Total current liabilities |
62,604 | 52,015 | 49,347 |
(1) | The 2019 Consolidated Financial Statements have been prepared according to the new IFRS 16 “Leases” standard with a new “right-of-use |
As of December 31, |
||||||||||||
2019 |
2020 |
2021 |
||||||||||
$ in thousands |
||||||||||||
Net Income (Loss) attributable to shareholders of Cellectis |
(102,091 |
) |
(81,074 |
) |
(114,197 |
) | ||||||
Adjustment of non-cash stock-based compensation expense: |
||||||||||||
Research and development expenses |
12,260 | 8,029 | 10,852 | |||||||||
Selling, general and administrative expenses |
14,621 | 8,707 | 2,266 | |||||||||
|
|
|
|
|
|
|||||||
Total non-cash stock-based compensation expense: |
26,881 | 16,736 | 13,118 | |||||||||
|
|
|
|
|
|
|||||||
Non-cash stock-based compensation expense attributable to non controlling interests |
(3,707 | ) | (2,371 | ) | (621 | ) | ||||||
|
|
|
|
|
|
|||||||
Adjusted Net Income (Loss) attributable to shareholders of Cellectis |
(78,849 |
) |
(66,709 |
) |
(101,700 |
) | ||||||
|
|
|
|
|
|
• | The AMELI-01 Study, which replaced the first clinical study for UCART123 on AML, is an open-label, Phase 1, single arm, multicenter clinical trial designed to evaluate the safety, expansion, persistence and clinical activities of UCART123 in patients with relapsed or refractory acute myeloid leukemia (r/r AML). The AMELI-01 Study is currently open for patient recruitment at University of Texas, MD Anderson Cancer Center (Houston, Texas), H. Lee Moffitt Cancer Center & Research Institute (Tampa, Florida), Dana-Farber / Partners CancerCare, Inc. (Boston, Massachusetts), New York Presbyterian / Weill Medical College of Cornell University (New York, New York), Northwestern University (Chicago, Illinois), University of Miami (Miami, Florida), the Regent of the University of California on behalf of its San Francisco Campus (San Francisco, California), and The Trustee of University of Pennsylvania (Philadelphia, Pennsylvania). |
• | The BALLI-01 Study is an open-label, Phase 1/2, single arm, multicenter clinical trial designed to evaluate the safety, expansion, persistence, and clinical activities of UCART22 in patients with relapsed or refractory acute lymphoblastic leukemia (r/r ALL). The BALLI-01 Study is currently open to patient recruitment at New York Presbyterian / Weill Medical College of Cornell University (New York, New York), Memorial Sloan Kettering Cancer Center (New York, New York), Children’s Hospital of Philadelphia (Philadelphia, Pennsylvania), the University of Chicago (Chicago, Illinois), University of Texas, MD Anderson Cancer Center (Houston, Texas), The Regents of the University of California on behalf of its Los Angeles campus (Los Angeles, California), Dana Farber/Mass General Brigham Cancer Care, Inc. (Boston, Massachusetts), and Hôpital Saint-Louis AP-HP (Paris, France). |
• | The MELANI-01 Study is an open-label, Phase 1, single arm, multicenter clinical trial designed to evaluate the safety, expansion, persistence and clinical activities of UCARTCS1 in patients with relapsed or refractory multiple myeloma. The MELANI-01 Study is currently open to patients recruitment at Hackensack University Medical Center (Hackensack, New Jersey), The University of Texas, MD Anderson Cancer Center (Houston, Texas), The regents of the University of California, on behalf of its San Francisco campus (San Francisco, California), and Mayo Clinic (Rochester, Minnesota). As of the date of this Annual Report, we are enrolling patients in the first dose level of the MELANI-01 Study. |
• | UCART20x22, which is in development as the first allogeneic dual CAR T-cell candidate product for B-cell malignancies; |
• | UCARTMESO, which is an allogeneic CAR T-cell candidate product for mesothelin expressing cancers; |
• | UCARTMUC1, which is an allogeneic CAR T-cell candidate product for mucin-1 expressing epithelial cancers; |
• | UCARTFAP, which is an allogeneic CAR-T candidate product targeting cancer associated fibroblasts (CAFs) in the tumor microenvironment. |
• | progress our sponsored clinical trials AMELI-01, BALLI-01 and MELANI-01, and initiate additional clinical trials for other self-owned product candidates; |
• | continue to advance the research and development of our current and future immuno-oncology product candidates; |
• | advance research and development efforts for our HSC product candidates; |
• | further develop and refine the manufacturing process for our product candidates; |
• | maintain our manufacturing facilities in Paris (France) and Raleigh (North Carolina, USA), continue production at our in-house manufacturing facilities and change or add additional manufacturers or suppliers of biological materials to support our in-house manufacturing capabilities; |
• | seek regulatory and marketing approvals for our product candidates, if any, that successfully complete development; |
• | establish a sales, marketing and distribution infrastructure to commercialize any products for which we may obtain marketing approval; |
• | seek to identify and validate additional product candidates; |
• | acquire or in-license other product candidates, technologies or biological material; |
• | make milestone or other payments under any in-license agreements; |
• | maintain, protect and expand our intellectual property portfolio; |
• | seek to attract and retain new and existing skilled personnel; |
• | create additional infrastructure to support our operations as a public company; |
• | experience any delays or encounter issues with any of the above. |
• | the CIR results in a cash inflow to us from the tax authorities; |
• | a company’s corporate income tax liability does not limit the amount of the CIR; and |
• | the CIR is not included in the determination of the corporate income tax. |
• | personnel costs, including salaries, related benefits and share-based compensation, for our employees engaged in scientific research and development functions; |
• | cost of third-party contractors such as contract research organizations, or CROs, and academic institutions involved in pre-clinical or clinical trials that we may conduct, or third-party contractors involved in field trials; |
• | purchases and manufacturing of biological materials, real-estate leasing costs as well as conferences and travel costs; |
• | costs to write and support the research for filing patents and; |
• | certain other expenses, such as expenses for use of laboratories and facilities for our research and development activities. |
• | the scope, rate of progress and expense of our ongoing as well as any additional pre-clinical studies, clinical trials and other research and development activities; |
• | clinical trial and early-stage results; |
• | the terms and timing of regulatory approvals; |
• | the expense of filing, prosecuting, defending and enforcing patent claims and other intellectual property rights; |
• | the ability to market, commercialize and achieve market acceptance for any product candidate that we may develop in the future; and |
• | the scope, rate of progress and expense of our ongoing as well as any additional studies for Calyxt’s product candidates, and other research and development activities. |
• | Revenue Recognition: Collaboration Agreements and Licenses, Sales of Products and Services (Note 3.1) |
• | Research Tax Credit (Note 3.1) |
• | Share-Based Compensation (Note 16) |
• | Provisions for risks and charges (Note 18) |
A. |
Operating Results |
For the year ended December 31, |
||||||||||||
2019 |
2020 |
2021 |
||||||||||
($ in thousands) |
||||||||||||
Revenues and other income |
||||||||||||
Revenues |
15,190 | 73,949 | 57,293 | |||||||||
Other income |
7,800 | 8,507 | 9,778 | |||||||||
|
|
|
|
|
|
|||||||
Total revenues and other income |
22,990 |
82,456 |
67,071 |
|||||||||
|
|
|
|
|
|
|||||||
Operating expenses |
||||||||||||
Cost of revenue |
(11,392 | ) | (36,275 | ) | (31,360 | ) | ||||||
Research and development expenses |
(92,042 | ) | (86,950 | ) | (129,030 | ) | ||||||
Selling, general and administrative expenses |
(43,017 | ) | (44,201 | ) | (37,869 | ) | ||||||
Other operating income (expenses) |
(91 | ) | (467 | ) | 511 | |||||||
|
|
|
|
|
|
|||||||
Operating income (loss) |
(123,552 |
) |
(85,437 |
) |
(130,677 |
) | ||||||
|
|
|
|
|
|
|||||||
Financial income |
11,971 | 5,468 | 13,234 | |||||||||
Financial expenses |
(3,631 | ) | (17,514 | ) | (7,665 | ) | ||||||
|
|
|
|
|
|
|||||||
Net Financial gain (loss) |
8,340 |
(12,046 |
) |
5,570 |
||||||||
|
|
|
|
|
|
|||||||
Income (loss) from continuing operations |
(115,212 | ) | (97,483 | ) | (125,107 | ) | ||||||
Net income (loss) |
(115,212 |
) |
(97,483 |
) |
(125,107 |
) | ||||||
|
|
|
|
|
|
|||||||
Attributable to shareholders of Cellectis |
(102,091 | ) | (81,074 | ) | (114,197 | ) | ||||||
Attributable to non-controlling interests |
(13,121 | ) | (16,409 | ) | (10,910 | ) |
For the year ended December 31, |
% change |
|||||||||||||||||||
($ in thousands) |
2019 |
2020 |
2021 |
2019 vs 2020 |
2020 vs 2021 |
|||||||||||||||
Collaboration agreements |
6,055 | 48,823 | 29,971 | 706.3 | % | -38.6 | % | |||||||||||||
Other revenues |
9,135 | 25,126 | 27,322 | 175.1 | % | 8.7 | % | |||||||||||||
Revenues |
15,190 |
73,949 |
57,293 |
386.8 |
% |
-22.5 |
% |
For the year ended December 31, |
% change |
|||||||||||||||||||
($ in thousands) |
2019 |
2020 |
2021 |
2019 vs 2020 |
2020 vs 2021 |
|||||||||||||||
Research tax credit |
7,800 | 8,433 | 8,239 | 8.1 | % | -2.3 | % | |||||||||||||
Other income |
— | 74 | 1,539 | n.a. | 1980.2 | % | ||||||||||||||
Other income |
7,800 |
8,507 |
9,778 |
9.1 |
% |
14.9 |
% |
For the year ended December 31, |
% change |
|||||||||||||||||||
($ in thousands) |
2019 |
2020 |
2021 |
2019 vs 2020 |
2020 vs 2021 |
|||||||||||||||
Cost of goods sold |
(9,280 | ) | (34,168 | ) | (29,517 | ) | 268.2 | % | -13.6 | % | ||||||||||
Royalty expenses |
(2,112 | ) | (2,107 | ) | (1,844 | ) | -0.2 | % | -12.5 | % | ||||||||||
Cost of revenue |
(11,392 |
) |
(36,275 |
) |
(31,360 |
) |
218.4 |
% |
-13.5 |
% |
For the year ended December 31, |
% change |
|||||||||||||||||||
($ in thousands) |
2019 |
2020 |
2021 |
2019 vs 2020 |
2020 vs 2021 |
|||||||||||||||
Personnel expenses |
(34,911 | ) | (37,903 | ) | (55,080 | ) | 8.6 | % | 45.3 | % | ||||||||||
Purchases, external expenses and other |
(57,131 | ) | (49,047 | ) | (73,950 | ) | -14.1 | % | 50.8 | % | ||||||||||
Research and development expenses |
(92,042 |
) |
(86,950 |
) |
(129,030 |
) |
-5.5 |
% |
48.4 |
% |
For the year ended December 31, |
% change |
|||||||||||||||||||
($ in thousands) |
2019 |
2020 |
2021 |
2019 vs 2020 |
2020 vs 2021 |
|||||||||||||||
Personnel expenses |
(27,934 | ) | (24,524 | ) | (17,729 | ) | -12.2 | % | -27.7 | % | ||||||||||
Purchases, external expenses and other |
(15,083 | ) | (19,677 | ) | (20,140 | ) | 30.5 | % | 2.4 | % | ||||||||||
Selling, general and administrative expenses |
(43,017 |
) |
(44,201 |
) |
(37,869 |
) |
2.8 |
% |
-14.3 |
% |
For the year ended December 31, |
% change |
|||||||||||||||||||
($ in thousands) |
2019 |
2020 |
2021 |
2019 vs 2020 |
2020 vs 2021 |
|||||||||||||||
Other operating income (expenses) |
(91 | ) | (467 | ) | 511 | 413.2 | % | -209.4 | % |
For the year ended December 31, |
% change |
|||||||||||||||||||
($ in thousands) |
2019 |
2020 |
2021 |
2019 vs 2020 |
2020 vs 2021 |
|||||||||||||||
Financial income |
11,971 | 5,468 | 13,234 | -54.3 | % | 142.0 | % |
For the year ended December 31, |
% change |
|||||||||||||||||||
($ in thousands) |
2019 |
2020 |
2021 |
2019 vs 2020 |
2020 vs 2021 |
|||||||||||||||
Financial expenses |
(3,631 | ) | (17,514 | ) | (7,665 | ) | 382.3 | % | -56.2 | % |
For the year ended December 31, |
% change |
% change |
||||||||||||||||||
($ in thousands) |
2019 |
2020 |
2021 |
2019 vs 2020 |
2020 vs 2021 |
|||||||||||||||
Net income (loss) |
(115,212 | ) | (97,483 | ) | (125,107 | ) | -15.4 | % | 28.3 | % |
For the year ended December 31, |
% change |
% change |
||||||||||||||||||
($ in thousands) |
2019 |
2020 |
2021 |
2019 vs 2020 |
2020 vs 2021 |
|||||||||||||||
Gain (loss) attributable to non-controlling interests |
(13,121 | ) | (16,409 | ) | (10,910 | ) | 25.1 | % | -33.5 | % |
For the year ended December 31, 2019 |
For the year ended December 31, 2020 |
For the year ended December 31, 2021 |
||||||||||||||||||||||||||||||||||
($ in thousands) |
Plants |
Therapeutics |
Total reportable segments |
Plants |
Therapeutics |
Total reportable segments |
Plants |
Therapeutics |
Total reportable segments |
|||||||||||||||||||||||||||
External revenues |
7,294 | 7,896 | 15,190 | 22,892 | 51,057 | 73,949 | 26,946 | 30,347 | 57,293 | |||||||||||||||||||||||||||
External other income |
— | 7,800 | 7,800 | — | 8,507 | 8,507 | 1,528 | 8,250 | 9,778 | |||||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||
External revenues and other income |
7,294 |
15,696 |
22,990 |
22,892 |
59,564 |
82,456 |
28,475 |
38,597 |
67,071 |
|||||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||
Cost of revenue |
(9,275 | ) | (2,117 | ) | (11,392 | ) | (34,324 | ) | (1,951 | ) | (36,275 | ) | (29,517 | ) | (1,844 | ) | (31,360 | ) | ||||||||||||||||||
Research and development expenses |
(12,390 | ) | (79,652 | ) | (92,042 | ) | (9,903 | ) | (77,048 | ) | (86,950 | ) | (11,190 | ) | (117,840 | ) | (129,030 | ) | ||||||||||||||||||
Selling, general and administrative expenses |
(26,090 | ) | (16,927 | ) | (43,017 | ) | (21,688 | ) | (22,513 | ) | (44,201 | ) | (14,987 | ) | (22,882 | ) | (37,869 | ) | ||||||||||||||||||
Other operating income and expenses |
25 | (116 | ) | (91 | ) | (103 | ) | (363 | ) | (466 | ) | 23 | 488 | 511 | ||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||
Total operating expenses |
(47,730 |
) |
(98,812 |
) |
(146,542 |
) |
(66,018 |
) |
(101,875 |
) |
(167,893 |
) |
(55,671 |
) |
(142,077 |
) |
(197,748 |
) | ||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||
Operating income (loss) before tax |
(40,436 |
) |
(83,116 |
) |
(123,552 |
) |
(43,126 |
) |
(42,311 |
) |
(85,437 |
) |
(27,196 |
) |
(103,481 |
) |
(130,677 |
) | ||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||
Net financial gain (loss) |
294 | 8,045 | 8,340 | (776 | ) | (11,270 | ) | (12,046 | ) | (1,162 | ) | 6,731 | 5,570 | |||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||
Net income (loss) |
(40,142 |
) |
(75,071 |
) |
(115,212 |
) |
(43,902 |
) |
(53,581 |
) |
(97,483 |
) |
(28,358 |
) |
(96,749 |
) |
(125,107 |
) | ||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||
Non-controlling interests |
13,121 | — | 13,121 | 16,409 | — | 16,409 | 10,910 | — | 10,910 | |||||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||
Net income (loss) attributable to shareholders of Cellectis |
(27,021 |
) |
(75,071 |
) |
(102,091 |
) |
(27,493 |
) |
(53,581 |
) |
(81,074 |
) |
(17,448 |
) |
(96,749 |
) |
(114,197 |
) | ||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||
R&D non-cash stock-based expense attributable to shareholder of Cellectis |
1,619 | 10,010 | 11,629 | 801 | 6,790 | 7,591 | 909 | 9,381 | 10,290 | |||||||||||||||||||||||||||
SG&A non-cash stock-based expense attributable to shareholder of Cellectis |
6,673 | 4,940 | 11,613 | 3,536 | 3,238 | 6,774 | 95 | 2,113 | 2,207 | |||||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||
Adjustment of share-based compensation attributable to shareholders of Cellectis |
8,292 |
14,950 |
23,242 |
4,337 |
10,028 |
14,365 |
1,004 |
11,493 |
12,497 |
|||||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||
Adjusted net income (loss) attributable to shareholders of Cellectis |
(18,729 |
) |
(60,121 |
) |
(78,849 |
) |
(23,156 |
) |
(43,553 |
) |
(66,709 |
) |
(16,444 |
) |
(85,256 |
) |
(101,700 |
) | ||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||
Depreciation and amortization tangible and intangible assets |
(1,233 | ) | (5,642 | ) | (6,875 | ) | (1,869 | ) | (7,950 | ) | (9,819 | ) | (1,208 | ) | (6,371 | ) | (7,579 | ) | ||||||||||||||||||
Additions to tangible and intangible assets |
2,998 | 14,668 | 17,666 | 1,786 | 48,813 | 50,599 | 1,187 | 15,451 | 16,638 |
B. |
Liquidity and Capital Resources |
For the year ended December 31, |
||||||||||||
2019 |
2020 |
2021 |
||||||||||
($ in thousands) |
||||||||||||
Net cash flows provided by (used in) operating activities |
(69,142 | ) | (80,262 | ) | (104,562 | ) | ||||||
Net cash flows provided by (used in) investing activities |
(35,872 | ) | (54,342 | ) | 7,279 | |||||||
Net cash flows provided by (used in) financing activities |
(3,862 | ) | 27,322 | 47,525 | ||||||||
|
|
|
|
|
|
|||||||
Total |
(108,876 |
) |
(107,282 |
) |
(49,758 |
) | ||||||
|
|
|
|
|
|
|||||||
Effect of exchange rate changes on cash |
(2,103 | ) | 7,908 | (5,754 | ) |
• | the initiation, progress, timing, costs and results of pre-clinical and clinic studies for our product candidates; |
• | the capacity of manufacturing our products in France and in the United States; |
• | the outcome, timing and cost of regulatory approvals by U.S. and non-U.S. regulatory authorities, including the possibility that regulatory authorities will require that we perform more studies than those that we currently expect; |
• | the ability of our product candidates to progress through clinical development successfully; |
• | the cost of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights; |
• | our need to expand our research and development activities; |
• | our need and ability to hire additional personnel; |
• | our need to implement additional infrastructure and internal systems, including manufacturing processes for our product candidates; |
• | the effect of competing technological and market developments; and |
• | the cost of establishing sales, marketing and distribution capabilities for any products for which we may receive regulatory approval. |
As of December 31, 2021 |
Total |
Less than 1 year |
1 - 3 years |
3 - 5 years |
More than 5 years |
|||||||||||||||
$ in thousands |
||||||||||||||||||||
Lease agreements |
108,312 | 12,855 | 24,728 | 20,281 | 50,447 | |||||||||||||||
License and collaboration agreements |
17,580 | 1,530 | 3,060 | 3,060 | 9,930 | |||||||||||||||
Clinical & Research and Development agreements |
444 | 444 | — | — | — | |||||||||||||||
IT licensing agreements |
1,101 | 445 | 655 | — | — | |||||||||||||||
State Guaranteed loan « PGE » |
21,016 | 2,246 | 10,477 | 8,294 | — | |||||||||||||||
Loan to finance leasehold improvements |
1,367 | 108 | 241 | 279 | 739 | |||||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||
Total contractual obligations |
149,821 |
17,629 |
39,162 |
31,914 |
61,116 |
|||||||||||||||
|
|
|
|
|
|
|
|
|
|
• | Lease agreements regarding Cellectis’ corporate headquarter in Paris, France, its administrative and research and development facility in New York, New York, and its manufacturing facilities in Paris, France, and Raleigh, North Carolina, as well as leased equipment for $108.3 million, of which $12.9 million are payable in 2022, |
• | License and collaboration agreements with third parties that subject the Company to certain fixed license fees, as well as fees based on future events, such as research and sales milestones for $17.6 million, of which $1.5 million are payable in 2022, |
• | Clinical and research agreements for $0.4 million, payable in 2022, |
• | IT licensing agreements for $1.1 million, of which $0.4 million are payable in 2022, |
• | A state Guaranteed loan “PGE” of $21.0 million, of which $2.2 millions are payable in 2022, |
• | And a loan to finance leasehold improvements of $1.4 million, of which $0.1 million are payable in 2022 |
• | Liability for minimum lease payments for its corporate headquarters and lab facilities and equipment leases due within the next five years in an aggregate amount of $7.7 million, of which $1.7 million is payable in 2022; |
• | Remaining severance obligation to Mr. Blome, its former Chief Executive Officer, due within the next two years in an aggregate amount of $1.8 million, of which $1.1 million is payable in 2022. |
C. |
Research and Development, Patents and Licenses, etc. |
D. |
Trend Information |
E. |
Accounting Estimates. |
ITEM 6. |
DIRECTORS, SENIOR MANAGEMENT AND EMPLOYEES |
A. |
Directors and Senior Management |
Name |
Age |
Position(s) | ||
Executive Officers: |
||||
André Choulika, Ph.D. | 57 | Director, Chief Executive Officer and Co-Founder | ||
Carrie Brownstein, MD | 52 | Chief Medical Officer | ||
Steven Doares, Ph.D. | 62 | Senior Vice President of US Manufacturing | ||
Philippe Duchateau, Ph.D. | 59 | Chief Scientific Officer | ||
Kyung Nam-Wortman |
52 | Chief Human Resources Officer | ||
Stephan Reynier | 53 | Chief Regulatory & Pharmaceutical Compliance Officer | ||
David Sourdive, Ph.D. | 55 | Director, Deputy Chief Executive Officer, Executive Vice President, CMC and Manufacturing | ||
Arthur Stril | 33 | Chief Business Officer | ||
Marie-Bleuenn Terrier Bing Wang, Ph.D. |
40 45 |
General Counsel Chief Financial Officer | ||
Non-Employee Directors: |
||||
Jean-Pierre Garnier, Ph.D. | 74 | Chairman of the Board and Director | ||
Laurent Arthaud | 59 | Director | ||
Pierre Bastid | 67 | Director | ||
Rainer Boehm | 61 | Director | ||
Alain Godard | 76 | Director | ||
Hervé Hoppenot | 62 | Director | ||
Annick Schwebig, M.D. Donald A. Bergstrom |
71 50 |
Director Observer |
Board Diversity Matrix |
||||||||||
Country of Principal Executive Offices: | France | |||||||||
Foreign Private Issuer | Yes | |||||||||
Disclosure Prohibited under Home Country Law | No | |||||||||
Total Number of Directors and Board Observers | 10 | |||||||||
Female |
Male |
Non- Binary |
Did Not Disclose Gender |
|||||||
Part I: Gender Identity |
||||||||||
Directors | 1 | 9 | 0 | 0 | ||||||
Part II: Demographic Background |
||||||||||
Underrepresented Individual in Home Country Jurisdiction | 0 | |||||||||
LGBTQ |
0 | |||||||||
Did Not Disclose Demographic Background | 0 |
B. |
Compensation |
Directors |
Compensation (Gross Salary+Bonus)* |
Board fees* | Out-of- pocket expenses* |
Equity awards granted in 2021 |
||||||||||||
A. Choulika |
$ | 879,062 | — | — | |
155,000 SO 33,000 free shares |
| |||||||||
D. Sourdive |
$ | 580,278 | — | — | |
34,000 SO 7,000 free shares |
| |||||||||
J.P. Garnier |
— | — | — | 27,465 SO | ||||||||||||
L. Arthaud |
— | — | — | — | ||||||||||||
P. Bastid |
— | $ | 88,763 | — | — | |||||||||||
R. Boehm |
— | $ | 71,010 | — | — | |||||||||||
D. Bergstrom |
— | $ | 21,040 | — | — | |||||||||||
A. Godard |
— | $ | 88,763 | $ | 452 | — | ||||||||||
H. Hoppenot |
— | $ | 82,845 | $ | 9,406 | — | ||||||||||
A. Schwebig |
— | $ | 82,845 | — | — |
* | The conversation rate used is the average rate of the period |
• | termination (including by non-renewal) of such person’s employment other than for gross misconduct (faute lourde |
• | for any non-employee officer or US officer, any material reduction of such executive’s duties or cash compensation. |
• | employee warrants (otherwise known as bons de souscription de parts de créateur d’entreprise or BSPCE), granted only to employees of Cellectis; |
• | non-employee warrants (otherwise known as bons de souscription d’actions or BSA), granted only to non-employee directors and other service providers or consultants not eligible for employee warrants; |
• | restricted, or free, shares (otherwise known as actions gratuites); and |
• | stock options (otherwise known as options de souscription d’actions). |
• | 700 free shares have been granted to a new employee in November 2021 under the 2021 Free Share Plan and are under the vesting period of three years; |
• | 1,300 stock options have been granted a new employee in November 2021 under the 2021 Stock Option Plan and are under the vesting period of four years; |
• | 2,100 free shares have been granted to a new employee in November 2021 under the 2021 Free Share Plan and are under the vesting period of three years; |
• | 4,500 stock options have been granted to a new employee in November 2021 under the 2021 Stock Option Plan and are under the vesting period of four years; |
• | 4,500 free shares have been granted to a new employee in October 2021 under the 2021 Free Share Plan and are under the vesting period of three years; |
• | 9,000 stock options have been granted to a new employee in October 2021 under the 2021 Stock Option Plan and are under the vesting period of four years; |
• | 12,975 free shares have been granted to certain of our employees in September 2021 under the 2021 Free Share Plan and are under the vesting period of three years; |
• | 25,950 stock options have been granted to certain of our employees in September 2021 under the 2021 Stock Option Plan and are under the vesting period of four years; |
• | 158,000 free shares have been granted in May 2021 under the Second 2018 Free Share Plan with a minimum vesting period of three years. These free shares have been granted to a large number of our employees of which 16,000 free shares have been granted to our Chief Medical Officer, our Senior Vice President of US Manufacturing and our Chief Regulatory and Compliance Officer, under non-market performance vesting conditions and with a minimum vesting period of three years; |
• | 35,000 stock options have been granted to certain of our officers in May 2021: our Chief Medical Officer, our Chief Regulatory and Compliance Officer and our Senior Vice President of US Manufacturing, under the 2018 Stock Option Plan and are under the vesting period of four years; |
• | 2,000 free shares have been granted to a new employee in May 2021 under the 2018 Free Share Plan and are under the vesting period of three years; |
• | 3,500 stock options have been granted to a new employee in May 2021 under the 2018 Stock Option Plan and are under the vesting period of four years; |
• | 27,465 stock options have been granted to one of our officers (our chairman of the board of directors) in April 2021 under the 2018 Stock Option Plan and are under the vesting period of four years; |
• | 330,041 free shares have been granted to certain of our employees in March 2021 under the Second 2018 Free Share Plan and are under a vesting period of three years; of which 103,000 free shares have been granted to our Executive Officers, under non-market performance vesting conditions; |
• | 924,520 stock options have been granted to certain of our employees in March 2021 under the 2018 Stock Option Plan and are under the vesting period of four years, of which 495,000 stock option have been granted to our Executive Officers. |
• | stock options for the purchase of 200,000 shares of Calyxt’s common stock and 50,000 restricted stock units granted under Calyxt’s 2017 Omnibus Incentive Plan, in each case vesting in equal installments on the first three anniversaries of Mr. Carr’s start date at Calyxt; and |
• | performance stock units to acquire up to 600,000 shares of Calyxt’s common stock, which will vest based on Calyxt’s achievement for a period of 30 consecutive calendar days of specified trading price levels during a three-year performance period following the grant date, granted under a one-time inducement plan. |
C. |
Board Practices |
Name |
Current Position |
Year of Initial Appointment |
Term Expiration Year | |||
Jean-Pierre Garnier, M.D. |
Chairman and Director |
2020 | 2023 | |||
André Choulika, Ph.D. |
Director and CEO |
2000 | 2024 | |||
David Sourdive, Ph.D. |
Director and Deputy CEO |
2000 | 2024 | |||
Alain Godard |
Director | 2007 | 2024 | |||
Pierre Bastid |
Director | 2011 | 2023 | |||
Laurent Arthaud |
Director | 2011 | 2023 | |||
Annick Schwebig, M.D. |
Director | 2011 | 2023 | |||
Hervé Hoppenot |
Director | 2017 | 2023 | |||
Rainer Boehm |
Director | 2017 | 2023 | |||
Donald A. Bergstrom |
Observer | 2021 | 2024 |
• | review on a preliminary basis and express its opinion on the draft annual and quarterly financial statements prior to the board of directors officially receiving the financial statements; |
• | examine the critical accounting policies and practices of the Company, including their relevance and consistency used for the preparation of the Company’s consolidated financial statements and rectify any failure to comply with these policies and practices; |
• | monitor the scope of consolidation and review, where necessary, any explanations in connection thereto; |
• | interview, when necessary, the statutory auditors, the chairman of the board of directors, the chief executive officer, the chief financial officer, the employees in charge of our internal controls or any other management personnel; these discussions may take place, where required, without the presence of the chairman of our board of directors and the chief executive officer; and |
• | examine—prior to their publication—the draft annual and interim financial statements, the draft annual report and any other draft financial statements (including projected financial statements) prepared for the needs of upcoming material transactions together with the related press releases; |
• | assess the efficiency and quality of internal control systems and procedures within the consolidated Company; |
• | examine, with the persons in charge of the internal audit, and, if necessary, outside of the presence of the chairman of the board of directors and the chief executive officer, the contingency and action plans with respect to internal audit, the findings following the implementation of these actions and the recommendations and follow-up actions in connection therewith; and |
• | entrust the internal audit department with any mission which the committee deems necessary; |
• | examine any question relating to the appointment, renewal or dismissal of our statutory auditors and their fees regarding the performance of their control review functions; |
• | oversee the rules relating to the use of the statutory auditors for assignments other than the audit of the financial statements and, more generally, ensure that we comply with the principles guaranteeing the statutory auditors’ independence; |
• | at least annually, review and discuss the information provided by management and the auditors relating to the independence of the audit firm; |
• | pre-approve any services entrusted to the statutory auditors which is outside of the scope of the annual audit; |
• | review every year with the statutory auditors all fees paid to by the Company and its subsidiaries to any networks to which the auditors belong, their work plan, their findings and recommendations, as well as actions taken by us following such recommendations; |
• | review and discuss with the statutory auditors their comments on internal controls over financial reporting and any matters that have come to the attention of the statutory auditors that lead them to believe that modification to our disclosures about changes in internal control over financial reporting is necessary for management’s certifications pursuant to Section 302 of the Sarbanes-Oxley Act; |
• | discuss if necessary any points of disagreement between the statutory auditors and the officers of the Company that may arise within the scope of these operations; and |
• | review and discuss with the statutory auditors the plans for, and the scope of, the annual audit and other examinations; and |
• | review on a regular basis the financial situation, the cash position and the material risks and undertakings of the Company and its subsidiaries; and |
• | review the risk management policy and the process implemented to evaluate and manage these risks. |
• | review the compensation of our employees and managers of the Company and its subsidiaries (fixed and variable compensations, bonus, etc.) and make any recommendation to our board of directors in connection therewith; |
• | review equity incentive plans (non-employee warrants, stock options, restricted (free) shares, etc.) and make recommendations to our board of directors in connection therewith; |
• | make recommendations to our board of directors regarding the compensation, pension and insurance plans, benefits in kind and other various pecuniary rights, of officers, as well as the allocation of equity incentive instruments granted to executive officers and directors of the Company; |
• | evaluate and make recommendations on the compensation policies and programs of executive officers and on the compensation of directors; |
• | recommend the approval, adoption and amendment of all cash- and equity-based incentive compensation plans in which any of our executive officers or directors participate and all other equity-based plans; |
• | review any proposed employment agreement with, and any proposed severance or retention plans or agreements applicable to, any of our executive officers; |
• | review, at least annually, corporate goals and objectives relevant to the compensation of our executive officers; and |
• | evaluate the performance of the executive officers in light of corporate goals and objectives and recommend compensation levels for these executive officers based on those evaluations and any other factors the compensation committee deems appropriate. |
D. |
Employees |
E. |
Share Ownership |
ITEM 7. |
MAJOR SHAREHOLDERS AND RELATED PARTY TRANSACTIONS |
A. |
Major Shareholders. |
• | each beneficial owner of more than 5% of our outstanding ordinary shares; |
• | each of our directors and executive officers; and |
• | all of our directors and executive officers as a group. |
Name of Beneficial Owner |
Ordinary Shares Beneficially Owned |
|||||||
Number |
Percentage |
|||||||
5% Shareholders: |
||||||||
Baillie Gifford & Co. (1) |
4,335,883 | 9.53 | % | |||||
Bpifrance Participations (2) |
3,686,287 | 8.10 | % | |||||
ARK Investment Management LLC (3) |
2,941,556 | 6.47 | % | |||||
Pfizer, Inc. (4) |
2,787,024 | 6.13 | % |
Name of Beneficial Owner |
Ordinary Shares Beneficially Owned |
|||||||
Number |
Percentage |
|||||||
Directors and Executive Officers: |
||||||||
André Choulika, Ph.D. (5) |
2,081,134 | 4.58 | % | |||||
David Sourdive, Ph.D. (6) |
1,813,160 | 3.99 | % | |||||
Philippe Duchateau, Ph.D. (7) |
701,526 | 1.54 | % | |||||
Marie-Bleuenn Terrier (8) |
683,441 | 1.50 | % | |||||
Stephan Reynier (9) |
322,041 | * | ||||||
Arthur Stril (10) |
21,312 | * | ||||||
Carrie Brownstein (11) |
98,500 | * | ||||||
Steven Doares (12) |
14,874 | * | ||||||
Kyung Nam-Wortman (13) |
14,906 | * | ||||||
Alain Godard (14) |
238,724 | * | ||||||
Pierre Bastid (15) |
2,082,191 | 4.58 | % | |||||
Laurent Arthaud |
— | * | ||||||
Annick Schwebig, M.D. (16) |
202,115 | * | ||||||
Hervé Hoppenot (17) |
40,000 | * | ||||||
Rainer Boehm (18) |
40,000 | * | ||||||
Jean-Pierre Garnier (19) |
7,581 | * | ||||||
Donald A. Bergstrom |
— | * | ||||||
All directors and executive officers as a group (17 persons) |
8,361,505 | 18.38 | % |
* | Represents beneficial ownership of less than one per cent. |
(1) | Amounts beneficially owned by Baillie Gifford & Co. were reported pursuant to a Schedule 13G amendment filed with the SEC on January 11, 2022 by “Baillie Gifford & Co.” The address of Baillie Gifford & Co. is Calton Square, 1 Greenside Row, Edinburgh EH1 3AN. |
(2) | Consists of (a) 3,686,287 ordinary shares and 6,565,787 voting rights beneficially owned by Bpifrance Participations S.A., (b) 3,961,387 ordinary shares and 6,840,887 voting rights beneficially owned by Caisse des Dépôts, (c) 3,686,287 ordinary shares and 6,565,787 voting rights beneficially owned by EPIC Bpifrance and (d) 3,686,287 ordinary shares and 6,565,787 voting rights beneficially owned by Bpifrance S.A. Bpifrance Participations S.A., EPIC Bprifrance and Bprifrance S.A.’s address is 27-31, avenue du Général Leclerc, 94710 Maisons-Alfort Cedex, France. Caisse Dépôts’ address is 56, rue de Lille, 75007 Paris, France. |
(3) | Amounts beneficially owned by ARK Investment Management LLC were reported pursuant to a Schedule 13G amendment filed with the SEC on February 9, 2022 by ARK Investment Management LLC. ARK Investment Management LLC’s address is 3 East 28th Street, New York, NY 10016. |
(4) | The address of Pfizer, Inc. is 235 East 42nd Street, New York, New York 10017. Shares beneficially owned by Pfizer, Inc. were acquired by Pfizer OTC B.V. on July 31, 2014 in the context of a share capital increase in connection with the entry into a research and collaboration agreement between Pfizer Inc. and Cellectis S.A. |
(5) | Includes 219,173 ordinary shares that Mr. Choulika has the right to acquire pursuant to stock options granted in March 2015 under the 2015 Stock Option Plan, 200,000 ordinary shares that Mr. Choulika has the right to acquire pursuant to stock options granted in September 2015 governed by the 2015 Stock Option Plan, 160,701 ordinary shares that Mr. Choulika has the right to acquire pursuant to stock options granted in March 2016 under the 2015 Stock Option Plan, 226,477 ordinary shares that Mr. Choulika has the right to acquire pursuant to stock options granted in October 2016 under the 2016 Stock Option Plan, 135,000 ordinary shares that Mr. Choulika has the right to acquire pursuant to stock options granted in October 2017 under the 2017 Stock Option Plan, 105,000 ordinary shares that Mr. Choulika has the right to acquire pursuant to stock options granted in April 2019 under the 2018 Stock Option Plan and 38,750 ordinary shares that Mr. Choulika has the right to acquire pursuant to stock options granted in March 2021 under the 2018 Stock Option Plan. |
(6) | Includes 175,343 ordinary shares that Mr. Sourdive has the right to acquire pursuant to stock options granted in March 2015 under the 2015 Stock Option Plan, 175,000 ordinary shares that Mr. Sourdive has the right to acquire pursuant to stock options granted in September 2015 governed by the 2015 Stock Option Plan and 140,614 ordinary shares that Mr. Sourdive has the right to acquire pursuant to stock options granted in March 2016 under the 2015 Stock Option Plan, 198,168 ordinary shares that Mr. Sourdive has the right to acquire pursuant to stock options granted in October 2016 under the 2016 Stock Option Plan, 80,000 ordinary shares that Mr. Sourdive has the right to acquire pursuant to stock options granted in October 2017 under the 2017 Stock Option Plan, 52,500 ordinary shares that Mr. Sourdive has the right to acquire pursuant to stock options granted in April 2019 under the 2018 Stock Option Plan and 8,500. ordinary shares that Mr. Sourdive has the right to acquire pursuant to stock options granted in March 2021 under the 2018 Stock Option Plan, Includes 703,041 shares held by Viveoo SARL. |
(7) | Includes 131,508 ordinary shares that Dr. Duchateau has the right to acquire pursuant to stock options granted in March 2015 under the 2015 Stock Option Plan, 150,000 ordinary shares that Dr. Duchateau has the right to acquire pursuant to stock options granted in September 2015 governed by the 2015 Stock Option Plan, 120,526 ordinary shares that Dr. Duchateau has the right to acquire pursuant to stock options granted in March 2016 under the 2015 Stock Option Plan, 169,858 ordinary shares that Dr. Duchateau has the right to acquire pursuant to stock options granted in October 2016 under the 2016 Stock Option Plan, 30,000 ordinary shares that Dr. Duchateau has the right to acquire pursuant to stock options granted in October 2017 under the 2017 Stock Option Plan, 52,500 ordinary shares that Dr. Duchateau has the right to acquire pursuant to stock options granted in April 2019 under the 2018 Stock Option Plan and 8,500 ordinary shares that Dr. Duchateau has the right to acquire pursuant to stock options granted in March 2021 under the 2018 Stock Option Plan. |
(8) | Includes 87,671 ordinary shares that Mrs. Terrier has the right to acquire pursuant to stock options granted in March 2015 under the 2015 Stock Option Plan, 90,000 ordinary shares that Mrs. Terrier has the right to acquire pursuant to stock options granted in September 2015 governed by the 2015 Stock Option Plan, 140,614 ordinary shares that Mrs. Terrier has the right to acquire pursuant to stock options granted in March 2016 under the 2015 Stock Option Plan, 198,168 ordinary shares that Mrs. Terrier has |
the right to acquire pursuant to stock options granted in October 2016 under the 2016 Stock Option Plan, 80,000 ordinary shares that Mrs. Terrier has the right to acquire pursuant to stock options granted in October 2017 under the 2017 Stock Option Plan, 52,500 ordinary shares that Mrs. Terrier has the right to acquire pursuant to stock options granted in April 2019 under the 2018 Stock Option Plan and 8,500 ordinary shares that Mrs. Terrier has the right to acquire pursuant to stock options granted in March 2021 under the 2018 Stock Option Plan. |
(9) | Includes 39,452 ordinary shares that Mr. Reynier has the right to acquire pursuant to stock options granted in March 2015 under the 2015 Stock Option Plan, 40,000 ordinary shares that Mr. Reynier has the right to acquire pursuant to stock options granted in September 2015 governed by the 2015 Stock Option Plan, 58,856 ordinary shares that Mr. Reynier has the right to acquire pursuant to stock options granted in March 2016 under the 2015 Stock Option Plan, 67,609 ordinary shares that Mr. Reynier has the right to acquire pursuant to stock options granted in October 2016 under the 2016 Stock Option Plan, 40,000 ordinary shares that Mr. Reynier has the right to acquire pursuant to stock options granted in October 2017 under the 2017 Stock Option Plan, 52,500 ordinary shares that Mr. Reynier has the right to acquire pursuant to stock options granted in April 2019 under the 2018 Stock Option Plan and 8,500 ordinary shares that Mr. Reynier has the right to acquire pursuant to stock options granted in March 2021 under the 2018 Stock Option Plan. |
(10) | Includes 4,063 ordinary shares that Mr. Stril has the right to acquire pursuant to stock options granted in October 2018 under the 2018 Stock Option Plan, 8,750 ordinary shares that Mr. Stril has the right to acquire pursuant to stock options granted in April 2019 under the 2018 Stock Option Plan and 8,500 ordinary shares that Mr. Stril has the right to acquire pursuant to stock options granted in March 2021 under the 2018 Stock Option Plan. |
(11) | Includes 70,000 ordinary shares that Mrs. Brownstein has the right to acquire pursuant to stock options granted in April 2020 under the 2018 Stock Option Plan, 8,500 ordinary shares that Mrs. Brownstein has the right to acquire pursuant to stock options granted in March 2021 under the 2018 Stock Option Plan and 20,000 ordinary shares that Mrs. Brownstein has the right to acquire pursuant to stock options granted in April 2020 under the 2018 Free Share Plan. |
(12) | Includes 6,375 ordinary shares that Mr. Doares has the right to acquire pursuant to stock options granted in July 2020 under the 2018 Stock Option Plan and 8,500 ordinary shares that Mr. Doares has the right to acquire pursuant to stock options granted in March 2021 under the 2018 Stock Option Plan. |
(13) | Includes 6,406 ordinary shares that Mrs. Nam-Wortman has the right to acquire pursuant to stock options granted in November 2020 under the 2018 Stock Option Plan and 8,500 ordinary shares that Mrs. Nam-Wortman has the right to acquire pursuant to stock options granted in March 2021 under the 2018 Stock Option Plan. |
(14) | The ordinary shares include 50,000 non-employee warrants which are exercisable since March 27, 2016, 50,000 non-employee warrants, which are exercisable since September 8, 2016, 40,175 non-employee warrants, which are exercisable since March 14, 2017, 37,000 non-employee warrants, which are exercisable since October 28, 2017 and 40,000 non-employee warrants, which are exercisable since October 11, 2018. |
(15) | The ordinary shares include 50,000 non-employee warrants which are exercisable since March 27, 2016, 50,000 non-employee warrants, which are exercisable since September 8, 2016, 40,175 non-employee warrants, which are exercisable since March 14, 2017, 40,000 non-employee warrants, which are exercisable since October 28, 2017, 40,000 non-employee warrants, which are exercisable since October 11, 2018 and includes 1,743,678 shares held by Lohas SARL and 62,438 shares held by Kotys SA. |
(16) | The ordinary shares include 30,000 non-employee warrants which are exercisable since March 27, 2016, 50,000 non-employee warrants, which are exercisable since September 8, 2016, 40,175 non-employee warrants, which are exercisable since March 14, 2017, 40,000 non-employee warrants, which are exercisable since October 28, 2017 and 40,000 non-employee warrants, which are exercisable since October 11, 2018. |
(17) | The ordinary shares include 40,000 non-employee warrants which are exercisable since October 11, 2018. |
(18) | The ordinary shares include 40,000 non-employee warrants which are exercisable since October 11, 2018. |
(19) | Includes 7,582 ordinary shares that Mr. Garnier has the right to acquire pursuant to stock options granted in April 2021 under the 2018 Stock Option Plan. |
B. |
Related Party Transactions |
• | On March 4, 2021, we granted 495,000 stock options to our executive officers, with a vesting over four years. |
• | On March 5,2021, we granted 103,000 free shares to our executive officers, with a vesting over three years and subject to performance conditions. |
• | On April 13, 2021, we granted 27,465 stock options to the chairman of our board of directors, with a vesting between three and four years. |
• | On May 28, 2021, we granted to certain of our executive officers 35,000 stock options with a vesting of four years, and 16,000 free shares with a vesting over three years and subject to performance conditions; |
• | to approve any modification to Calyxt’s or any future Calyxt subsidiary’s share capital (e.g., share capital increase or decrease), the creation of any subsidiary by Calyxt, any grant of stock-based compensation, any distributions or initial public offering, merger, spin-off, liquidation, winding up or carve-out transactions; |
• | to approve Calyxt’s annual business plan and annual budget and any modification thereto; |
• | to approve any external growth transactions of Calyxt exceeding $500,000 and not included in the approved annual business plan and annual budget; |
• | to approve any investment and disposition decisions by Calyxt exceeding $500,000 and not included in the approved annual business plan and annual budget (it being understood that this clause excludes the purchase and sale of inventory as a part of the normal course of business); |
• | to approve any related-party agreement and any agreement or transaction between the executives or shareholders of Calyxt, on the one hand, and Calyxt or any of its subsidiaries, on the other hand; |
• | to approve any decision by Calyxt pertaining to the recruitment, dismissal/removal, or increase of the compensation of executives and corporate officers; |
• | to approve any material decision by Calyxt relating to a material litigation; |
• | to approve any decision by Calyxt relating to the opening of a social or restructuring plan or pre-insolvency proceedings; |
• | to approve any buyback by Calyxt of its own shares; |
• | to approve any new borrowings or debts of Calyxt exceeding $500,000 and early repayment of loans, if any (it being understood that we will approve the entering into of contracts for revolving loans and other short-term loans and the repayment of such for financing general operating activities, such as revolving loans for inventory or factoring of receivables); |
• | to approve grants by Calyxt of any pledges on securities; |
• | to develop new activities and businesses not described in the annual business plan and annual budget; |
• | to approve entry into any material agreement or partnership; and |
• | to approve any offshore and relocation activities of Calyxt. |
• | to nominate the greater of three members of Calyxt’s Board of Directors or a majority of the directors; |
• | to designate the Chairman of Calyxt’s Board of Directors and one member to each of the audit committee of the Board of Directors, the compensation committee of the Board of Directors and the nominating and corporation governance committee of the Board of Directors; |
• | to approve any amendments to Calyxt’ amended and restated certificate of incorporation or its amended and restated by-laws that would change the name of Calyxt, its jurisdiction of incorporation, the location of its principal executive offices, the purpose or purposes for which Calyxt is incorporated or the Cellectis approval items set forth in the stockholders agreement; |
• | to approve the payment of any regular or special dividends; |
• | to approve the commencement of any proceeding for the voluntary dissolution, winding up or bankruptcy of Calyxt or a material subsidiary; |
• | to approve any public or private offering, merger, amalgamation or consolidation of Calyxt or the spinoff of a business of Calyxt or any sale, conveyance, transfer or other disposition of Calyxt’s assets; and |
• | to approve any appointment to, or removal from, Calyxt’s Board of Directors, to the extent permissible by the laws of the State of Delaware. |
• | guarantees; |
• | insurance policies; |
• | mutual releases and indemnification matters; |
• | accounting, financial reporting and internal control issues; |
• | confidentiality; |
• | ability of the parties to compete with each other; and |
• | settlement of intercompany accounts. |
• | the benefits and perceived benefits to us; |
• | the opportunity costs of alternative transactions; |
• | the materiality and character of the related party’s interest; |
• | the actual or apparent conflict of interest of the related party; and |
• | the terms available to or from, as the case may be, unrelated third parties or to or from employees generally. |
C. |
Interests of Experts and Counsel |
ITEM 8. |
FINANCIAL INFORMATION |
A. |
Consolidated Statements and Other Financial Information |
B. |
Significant Changes |
ITEM 9. |
THE OFFER AND LISTING |
E. |
Dilution |
F. |
Expenses of the Issue |
ITEM 10. |
ADDITIONAL INFORMATION |
A. |
Share Capital |
B. |
Memorandum and Articles of Association |
• | all activities related to genetics and more specifically to genome engineering, in particular, research, development and invention, filing and use of patents and trademarks, sale and marketing, advising and assisting, in all areas, in particular in the agro-food, pharmaceutical, textile and environmental sectors; and |
• | more generally, all industrial, commercial, financial and civil transactions and transactions involving real estate or movable property relating directly or indirectly to any of the aforementioned corporate purposes or any similar or related purpose. |
• | to decrease our share capital; |
• | to meet our obligations arising from debt financial instruments issued by us that are exchangeable into shares; |
• | to meet our obligations arising from share option programs, or other allocations of shares, to our employees or to our managers or the employees or managers of our affiliate. |
• | a merger (i.e., in a French law context, a stock-for-stock two-thirds majority of the votes cast of the shareholders present, represented by proxy or voting by mail at the relevant meeting. The votes cast do not include votes attached to shares held by shareholders who did not take part in the vote, abstained or voted blank or null. |
• | a merger of our company into a company incorporated outside of the European Union would require the unanimous approval of our shareholders; |
• | under French law, a cash merger is treated as a share purchase and would require the consent of each participating shareholder; |
• | our shareholders have granted and may grant in the future our board of directors broad authorizations to increase our share capital or to issue additional ordinary shares or other securities (for example, warrants) to our shareholders, the public or qualified investors, including as a possible defence following the launching of a tender offer for our shares; |
• | our shareholders have preferential subscription rights proportional to their shareholding in our company on the issuance by us of any additional shares or securities giving the right, immediately or in the future, to new shares for cash or a set-off of cash debts, which rights may only be waived by the extraordinary general meeting (by a two-thirds majority vote) of our shareholders or on an individual basis by each shareholder; |
• | our board of directors has the right to appoint directors to fill a vacancy created by the resignation or death of a director, subject to the ratification by the shareholders of such appointment at the next shareholders’ meeting, which prevents shareholders from having the sole right to fill vacancies on our board of directors; |
• | our board of directors can only be convened by our chairman (and our managing director, if different from the chairman, may request the chairman to convene the board), or, when no board meeting has been held for more than two consecutive months, by directors representing at least one third of the total number of directors; |
• | our board of directors’ meetings can only be regularly held if at least half of the directors attend either physically or by way of videoconference or teleconference enabling the directors’ identification and ensuring their effective participation in the board of directors’ decisions; |
• | our shares take the form of bearer securities or registered securities, if applicable legislation so permits, according to the shareholder’s choice. Issued shares are registered in individual accounts opened by us or any authorized intermediary (depending on the form of such shares), in the name of each shareholder and kept according to the terms and conditions laid down by the legal and regulatory provisions; |
• | under French law, a non-French resident as well as any French entity controlled by non-French residents may have to file a declaration for statistical purposes with the Bank of France (Banque de France) following the date of certain foreign investments in us. Additionally, certain investments in a French company relating to certain strategic industries by individual or entities not residents in a member State of the European Union are subject to the prior authorization of the French Ministry of Economy — see the section of this Annual Report titled “Ownership of Shares and ADSs by Non-French Persons”; |
• | approval of at least a majority of the votes cast of our shareholders present, represented by a proxy, or voting by mail at the relevant ordinary shareholders’ general meeting is required to remove directors with or without cause; |
• | advance notice is required for nominations to the board of directors or for proposing matters to be acted upon at a shareholders’ meeting, except that a vote to remove and replace a director can be proposed at any shareholders’ meeting without notice; |
• | in the event where certain ownership thresholds would be crossed, a number of disclosures should be made by the relevant shareholder and in addition to certain obligations; see the section of this Annual Report titled “—Declaration of Crossing of Ownership Thresholds”; |
• | transfers of shares shall comply with applicable insider trading rules; |
• | pursuant to French law, the sections of the By-laws relating to the number of directors and election and removal of a director from office may only be modified by a resolution adopted by a two-thirds majority of the votes cast of our shareholders present, represented by a proxy or voting by mail at the meeting. The votes cast do not include votes attached to shares held by shareholders who did not take part in the vote, abstained or voted blank or null. |
• | Shareholders must make a declaration to us no later than the fourth trading day after such shareholder crosses the following thresholds: 5%, 10%, 15%, 20%, 25%, 30%, 33.33%, 50%, 66.66%, 90% and 95%. |
• | Shareholders must make a declaration to the AMF no later than the fourth trading day after such shareholder crosses the following thresholds: 50% and 95%. |
• | Subject to certain exemptions, any shareholder crossing, alone or acting in concert, the 50% threshold must file a mandatory public tender offer. |
• | issuing additional shares; |
• | increasing the par value of existing shares; |
• | creating a new class of equity securities; and |
• | exercising the rights attached to securities giving access to the share capital. |
• | issuances in consideration for cash; |
• | issuances in consideration for assets contributed in kind; |
• | issuances through an exchange offer; |
• | issuances by conversion of previously issued debt instruments; |
• | issuances by capitalization of profits, reserves or share premium; and |
• | subject to certain conditions, issuances by way of offset against debt incurred by us. |
C. |
Material Contracts |
D. |
Exchange Controls |
E. |
Taxation |
• | a broker; |
• | a dealer in securities, commodities or foreign currencies; |
• | a trader in securities that elects to use a mark-to-market |
• | a bank or other financial institution; |
• | a tax-exempt organization; |
• | an insurance company; |
• | a real estate investment trust; |
• | a controlled foreign corporation; |
• | a passive foreign investment company; |
• | a regulated investment company; |
• | an investor who is a U.S. expatriate, former U.S. citizen or former long term resident of the United States; |
• | a mutual fund; |
• | an individual retirement or other tax-deferred account; |
• | a holder liable for alternative minimum tax; |
• | a holder that actually or constructively owns 10% or more, by voting power or value, of our voting stock; |
• | a partnership or other pass-through entity for U.S. federal income tax purposes; |
• | a holder that holds ADSs as part of a straddle, hedging, constructive sale, conversion or other integrated transaction for U.S. federal income tax purposes; or |
• | a U.S. holder (as defined below) whose functional currency is not the U.S. Dollar. |
• | a citizen or resident of the United States; |
• | a corporation (or other entity treated as a corporation for U.S. federal income tax purposes) created or organized under the laws of the United States, any state thereof, or the District of Columbia; |
• | an estate whose income is subject to U.S. federal income tax regardless of its source; or |
• | a trust if (1) a U.S. court can exercise primary supervision over the trust’s administration and one or more U.S. persons are authorized to control all substantial decisions of the trust or (2) has a valid election in effect under applicable U.S. Treasury regulations to be treated as a U.S. person for U.S. federal income tax purposes. |
• | the gain is “effectively connected” with your conduct of a trade or business in the United States, and the gain is attributable to a permanent establishment (or in the case of an individual, a fixed place of business) that you maintain in the United States if that is required by an applicable income tax treaty as a condition for subjecting you to U.S. taxation on a net income basis; or |
• | you are an individual, you are present in the United States for 183 or more days in the taxable year of such sale, exchange or other disposition and certain other conditions are met. |
• | it is not a French tax resident for French tax purposes; and, |
• | it has not held more than 25% of our dividend rights, known as “ droits aux bénéfices sociaux |
• | it has not transferred ordinary shares or ADSs as part of redemption by Cellectis, in which case the proceeds may under certain circumstances be partially or fully characterized as dividends under French domestic law and, as result, be subject to French dividend withholding tax. As an exception, a U.S Holder, established, domiciled or incorporated in a non-cooperative State or territory as defined in Article 238-0 A of the FTC should be subject to a 75% withholding tax in France on any such capital gain, regardless of the fraction of the dividend rights it holds. |
F. |
Dividends and Paying Agents |
G. |
Statement by Experts |
H. |
Documents on Display |
I. |
Subsidiary Information |
ITEM 11. |
QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK |
ITEM 12. |
DESCRIPTION OF SECURITIES OTHER THAN EQUITY SECURITIES |
A. |
Debt Securities |
B. |
Warrants and Rights |
C. |
Other Securities |
D. |
American Depositary Shares |
Service |
Fees | |
• Issuance of ADSs upon deposit of shares (excluding issuance as a result of distributions of shares) |
Up to U.S. 5¢ per ADS issued | |
• Cancellation of ADSs |
Up to U.S. 5¢ per ADS canceled | |
• Distribution of cash dividends or other cash distributions (i.e., sale of rights and other entitlements) |
Up to U.S. 5¢ per ADS held |
Service |
Fees | |
• Distribution of ADSs pursuant to (1) stock dividends or other free stock distributions, or (2) 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 (i.e., spin-off shares) |
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 |
• | 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 ordinary shares on the share register and applicable to transfers of ordinary shares to or from the name of the custodian, the depositary or any nominees upon the making of deposits and withdrawals, respectively; |
• | certain cable, telex and facsimile transmission and delivery expenses; |
• | the expenses and charges incurred by the depositary in the conversion of foreign currency; |
• | the fees and expenses incurred by the depositary in connection with the compliance with exchange control regulations and other regulatory requirements applicable to ordinary shares, ADSs and ADRs; and |
• | the fees and expenses incurred by the depositary, the custodian, or any nominee in connection with the servicing or delivery of deposited property. |
ITEM 13. |
DEFAULTS, DIVIDEND ARREARAGES AND DELINQUENCIES. |
ITEM 14. |
MATERIAL MODIFICATIONS TO THE RIGHTS OF SECURITY HOLDERS AND USE OF PROCEEDS. |
ITEM 15. |
CONTROLS AND PROCEDURES. |
(a) | Our management, with the participation of our Chief Executive Officer and Chief Financial Officer, after evaluating the effectiveness of our disclosure controls and procedures (as defined in Exchange Act Rule 13a-15(e)) as of the end of the period covered by this Form 20-F, have concluded that our disclosure controls and procedures were effective as of December 31, 2021. |
(b) | Report of Management on Internal Control Over Financial Reporting |
(c) | See report of Ernst & Young et Autres, independent registered public accounting firm, included under “Item 18. Financial Statements” on page F-3. |
(d) | We have not made any significant change in internal controls over financial reporting during the year ended December 31, 2021. |
ITEM 16. |
RESERVED |
ITEM 16A. |
AUDIT COMMITTEE FINANCIAL EXPERT |
ITEM 16B. |
CODE OF ETHICS |
ITEM 16C. |
PRINCIPAL ACCOUNTANT FEES AND SERVICES |
2020 |
2021 |
|||||||
|
|
|||||||
($, in thousands) |
||||||||
Audit Fees |
676 |
* |
838 |
* | ||||
Audit-Related Fees |
— | — | ||||||
Tax Fees |
— | — | ||||||
Other Fees |
— | — | ||||||
Total |
676 |
838 |
(*) | $306 thousand and $404 thousand for Cellectis and $370 thousand and $434 thousand for Calyxt, respectively for the years ended December 31, 2020 and 2021. |
ITEM 16D. |
EXEMPTIONS FROM THE LISTING STANDARDS FOR AUDIT COMMITTEES |
ITEM 16E. |
PURCHASES OF EQUITY SECURITIES BY THE ISSUER AND AFFILIATED PURCHASERS |
ITEM 16F. |
CHANGE IN REGISTRANT’S CERTIFYING ACCOUNTANT |
ITEM 16G. |
CORPORATE GOVERNANCE |
ITEM 16H. |
MINE SAFETY DISCLOSURE |
ITEM 17. |
FINANCIAL STATEMENTS |
ITEM 18. |
FINANCIAL STATEMENTS |
ITEM 19. |
EXHIBITS |
104.1 |
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. |
# | Indicates a document previously filed with the Commission. |
* | Portions of this exhibit (indicated by asterisks) have been omitted pursuant to a request for confidential treatment. |
** | Portions of this exhibit (indicated by asterisks) have been omitted because they are not material and would likely cause competitive harm if disclosed. |
F-2 |
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F-6 |
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F-7 |
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F-8 |
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F-9 |
||||
F-10 |
||||
F-12 |
Auditor Firm Id: |
Auditor Name: |
Auditor Location: |
Revenue recognition from contracts with customers | ||
Description of the Matter |
As discussed in the section “Collaboration agreements and licenses” of Note 3.1 “Revenues and other income” in the consolidated financial statements, the Company earns revenue under collaboration and license agreements with its customers, that consist of: the licensing of rights to technology, research and development programs, research and development cost reimbursements and royalties. Under certain collaboration and license agreements, the Company receives non-refundable upfront payments and may receive milestone payments. For the year ended December 31, 2021, the Company recognized revenue from collaboration agreements and licenses of $30.0 million.The Company evaluates its collaboration and license agreements to determine: the separate performance obligations, including performance obligations to which non-refundable upfront payments relate, the transaction price (which may include variable consideration), the allocation of the transaction price to the performance obligations, and the timing of the satisfaction of the performance obligations.Based on its analysis, the Company determined that certain non-refundable upfront payments should be recognized as revenue when the performance obligation is satisfied. For performance obligations that are satisfied at a point in time, the Company recognizes revenue when control of the goods and/or services is transferred to the customer.In 2021, the Company entered into an agreement modified by an amendment to a research collaboration and non-exclusive license agreement which included a $20.0 million non-refundable upfront payment related to a non-exclusive license on a territory to develop and commercialize certain products. Based on its analysis, the Company determined that this non-refundable upfront payment constituted a performance obligation that had been fully satisfied and recognized the revenue point in time in the year ended December 31, 2021.Auditing the Company’s determination of the performance obligation in this amendment and the satisfaction of the performance obligations related to the non-refundable upfront payment received in 2021 required a high degree of auditor judgment. The complexity consisted of determining if the performance obligation will be satisfied over time or was satisfied point in time. | |
How We Addressed the Matter in Our Audit |
We obtained an understanding of, evaluated the design and tested the operating effectiveness of controls over the Company’s revenue recognition process related to collaboration and license agreements. For example, we tested controls over management’s assessment of its contractual arrangements including its determination of the separate performance obligations, and the determination of the satisfaction of the performance obligations. To assess management’s conclusions regarding whether non-refundable upfront payments should be recognized as revenue during the year, our audit procedures included, among others, evaluating the appropriateness of the Company’s accounting analysis for the amendment by inspecting and analyzing the provisions of the initial license agreement and its amendment including consideration of the obligations of each party to the contract and the timing thereof. We inquired of operational, accounting, and executive management personnel and the Company’s in-house legal counsel to corroborate our understanding of both the nature and the timing of the goods and services transferred to the customer and assessed the disclosures in the related footnotes. |
As of |
||||||||||||
Notes |
December 31, 2020 |
December 31, 2021 |
||||||||||
ASSETS |
||||||||||||
Non-current assets |
||||||||||||
Intangible assets |
5 |
|||||||||||
Property, plant, and equipment |
7 |
|||||||||||
Right-of-use |
6 |
|||||||||||
Non-current financial assets |
8.2 |
|||||||||||
Total non-current assets |
||||||||||||
Current assets |
||||||||||||
Inventories |
9 |
— | ||||||||||
Trade receivables |
10.1 |
|||||||||||
Subsidies receivables |
10.2 |
|||||||||||
Other current assets |
10.3 |
|||||||||||
Current financial assets |
11.1 |
|||||||||||
Cash and cash equivalents |
11.2 |
|||||||||||
Total current assets |
||||||||||||
TOTAL ASSETS |
||||||||||||
LIABILITIES |
||||||||||||
Shareholders’ equity |
||||||||||||
Share capital |
15 |
|||||||||||
Premiums related to the share capital |
15 |
|||||||||||
Currency translation adjustment |
( |
) | ( |
) | ||||||||
Retained earnings |
( |
) | ( |
) | ||||||||
Net income (loss) |
( |
) | ( |
) | ||||||||
Total shareholders’ equity - Group Share |
||||||||||||
Non-controlling interests |
||||||||||||
Total shareholders’ equity |
||||||||||||
Non-current liabilities |
||||||||||||
Non-current financial liabilities |
12 |
|||||||||||
Non-current lease debts |
12 |
|||||||||||
Non-current provisions |
18 |
|||||||||||
Other non-current liabilities |
— | |||||||||||
Total non-current liabilities |
||||||||||||
Current liabilities |
||||||||||||
Current financial liabilities |
— | |||||||||||
Current lease debts |
12 |
|||||||||||
Trade payables |
12 |
|||||||||||
Deferred revenues and contract liabilities |
14 |
|||||||||||
Current provisions |
18 |
|||||||||||
Other current liabilities |
13 |
|||||||||||
Total current liabilities |
||||||||||||
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY |
||||||||||||
For the year ended December 31, |
||||||||||||||||
Notes |
2019 |
2020 |
2021 |
|||||||||||||
Revenues and other income |
||||||||||||||||
Revenues |
3.1 |
|||||||||||||||
Other income |
3.1 |
|||||||||||||||
|
|
|
|
|
|
|||||||||||
Total revenues and other income |
||||||||||||||||
|
|
|
|
|
|
|||||||||||
Operating expenses |
||||||||||||||||
Cost of revenue |
3.2 |
( |
) | ( |
) | ( |
) | |||||||||
Research and development expenses |
3.2 |
( |
) | ( |
) | ( |
) | |||||||||
Selling, general and administrative expenses |
3.2 |
( |
) | ( |
) | ( |
) | |||||||||
Other operating income (expenses) |
( |
) | ( |
) | ||||||||||||
|
|
|
|
|
|
|||||||||||
Total operating expenses |
( |
) |
( |
) |
( |
) | ||||||||||
|
|
|
|
|
|
|||||||||||
Operating income (loss) |
( |
) |
( |
) |
( |
) | ||||||||||
|
|
|
|
|
|
|||||||||||
Financial income |
3.3 |
|||||||||||||||
Financial expenses |
3.3 |
( |
) | ( |
) | ( |
) | |||||||||
|
|
|
|
|
|
|||||||||||
Net Financial gain (loss) |
( |
) |
||||||||||||||
|
|
|
|
|
|
|||||||||||
Net income (loss) |
( |
) |
( |
) |
( |
) | ||||||||||
|
|
|
|
|
|
|||||||||||
Attributable to shareholders of Cellectis |
( |
) | ( |
) | ( |
) | ||||||||||
Attributable to non-controlling interests |
( |
) | ( |
) | ( |
) | ||||||||||
Basic / Diluted net income (loss) per share attributable to shareholders of Cellectis |
17 |
|||||||||||||||
Basic net income (loss) attributable to shareholders of Cellectis per share ($ /share) |
( |
) | ( |
) | ( |
) | ||||||||||
Diluted net income (loss) attributable to shareholders of Cellectis per share ($ /share) |
( |
) | ( |
) | ( |
) |
For the year ended December 31, |
||||||||||||
2019 |
2020 |
2021 |
||||||||||
Net income (loss) |
( |
) |
( |
) |
( |
) | ||||||
|
|
|
|
|
|
|||||||
Actuarial gains and losses |
( |
) | ( |
) | ||||||||
|
|
|
|
|
|
|||||||
Other comprehensive income (loss) that will not be reclassified subsequently to income or loss |
( |
) | ( |
) | ||||||||
|
|
|
|
|
|
|||||||
Currency translation adjustment |
( |
) | ( |
) | ||||||||
|
|
|
|
|
|
|||||||
Commodity derivative contracts |
— | — | ||||||||||
|
|
|
|
|
|
|||||||
Other comprehensive income (loss) that will be reclassified subsequently to income or loss |
( |
) | ( |
) | ||||||||
|
|
|
|
|
|
|||||||
Total Comprehensive income (loss) |
( |
) |
( |
) |
( |
) | ||||||
|
|
|
|
|
|
|||||||
Attributable to shareholders of Cellectis |
( |
) | ( |
) | ( |
) | ||||||
Attributable to non-controlling interests |
( |
) | ( |
) | ( |
) |
For the year ended December 31, |
||||||||||||||||
Notes |
2019 |
2020 |
2021 |
|||||||||||||
Cash flows from operating activities |
||||||||||||||||
Net income (loss) |
|
|
( |
) | ( |
) | ( |
) | ||||||||
|
|
|
|
|
|
|
|
|||||||||
Adjustment to reconcile net income (loss) to cash provided by (used in) operating activities |
|
|
||||||||||||||
Adjustments for |
|
|
||||||||||||||
Amortization and depreciation |
|
|
||||||||||||||
Net loss (income) on disposals |
|
|
||||||||||||||
Net financial loss (gain) |
|
|
( |
) | ( |
) | ||||||||||
Expenses related to share-based payments |
|
|
||||||||||||||
Provisions |
|
|
( |
) | ||||||||||||
Other non-cash items |
|
|
( |
) | ||||||||||||
|
|
|
|
|
|
|
|
|
||||||||
Gain upon the forgiveness of the Paycheck Protection Program loan |
|
|
( |
) | ||||||||||||
Realized foreign exchange gain (loss) |
|
|
( |
) | ||||||||||||
Interest (paid) / received (1) |
|
|
||||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Operating cash flows before change in working capital |
|
|
( |
) |
( |
) |
( |
) | ||||||||
|
|
|
|
|
|
|
|
|||||||||
Decrease (increase) in inventories |
|
|
( |
) | ||||||||||||
Decrease (increase) in trade receivables and other current assets |
|
|
( |
) | ( |
) | ( |
) | ||||||||
Decrease (increase) in subsidies receivables |
|
|
( |
) | ||||||||||||
(Decrease) increase in trade payables and other current liabilities |
|
|
( |
) | ||||||||||||
(Decrease) increase in deferred income |
|
|
( |
) | ( |
) | ( |
) | ||||||||
|
|
|
|
|
|
|
|
|||||||||
Change in working capital |
|
|
( |
) |
( |
) | ||||||||||
|
|
|
|
|
|
|
|
|||||||||
Net cash flows provided by (used in) operating activities |
|
|
( |
) |
( |
) |
( |
) | ||||||||
|
|
|
|
|
|
|
|
|||||||||
Cash flows from investment activities |
|
|
||||||||||||||
Proceeds from disposal of property, plant and equipment |
|
|
— | |||||||||||||
Acquisition of intangible assets |
|
|
( |
) | ( |
) | ( |
) | ||||||||
Acquisition of property, plant and equipment |
7 |
|
|
( |
) | ( |
) | ( |
) | |||||||
Net change in non-current financial assets |
8 |
|
|
( |
) | ( |
) | |||||||||
Sale (Acquisition) of current financial assets |
8 |
|
|
( |
) | ( |
) | |||||||||
|
|
|
|
|
|
|
|
|||||||||
Net cash flows provided by (used in) investment activities |
|
|
( |
) |
( |
) |
||||||||||
|
|
|
|
|
|
|
|
|||||||||
Cash flows from financing activities |
|
|
||||||||||||||
Proceeds from the exercise of Cellectis stock options (2) |
15 |
|
|
— | ||||||||||||
Proceeds from the exercise of Calyxt stock options |
15 |
|
|
( |
) | |||||||||||
Increase in share capital Cellectis, net of transaction costs |
15 |
|
|
— | — | |||||||||||
Increase in share capital Calyxt, net of transaction costs |
15 |
|
|
— | ||||||||||||
Increase in borrowings |
12 |
|
|
— | — | |||||||||||
Interest paid on financial debt |
|
|
( |
) | ||||||||||||
Payments on lease debts |
12 |
|
|
( |
) | ( |
) | ( |
) | |||||||
|
|
|
|
|
|
|
|
|||||||||
Net cash flows provided by (used in) financing activities |
|
|
( |
) |
||||||||||||
|
|
|
|
|
|
|
|
|||||||||
(Decrease) increase in cash and cash equivalents |
|
|
( |
) |
( |
) |
( |
) | ||||||||
|
|
|
|
|
|
|
|
|||||||||
Cash and cash equivalents at the beginning of the year |
|
|
||||||||||||||
Effect of exchange rate changes on cash |
|
|
( |
) | ( |
) | ||||||||||
|
|
|
|
|
|
|
|
|||||||||
Cash and cash equivalents at the end of the period |
8 |
|
|
|||||||||||||
|
|
|
|
|
|
|
|
(1) | In line with IAS 7.31, interests (paid) / received are presented separately |
(2) | Proceeds from the exercise of Cellectis stock options exercised in December 2020 were collected in January 2021, generating a $ |
Share Capital Ordinary Shares |
Equity |
|||||||||||||||||||||||||||||||||||||
Notes |
Number of shares |
Amount |
Premiums related to share capital |
Currency translation adjustment |
Retained earnings (deficit) |
Income (Loss) |
attributable to shareholders of Cellectis |
Non- controlling interests |
Total Shareholders’ Equity |
|||||||||||||||||||||||||||||
As of January 1, 2019 |
( |
) |
( |
) |
( |
) |
||||||||||||||||||||||||||||||||
Net Loss |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||||||||||||||||||||||||
Other comprehensive income (loss) |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||
Total comprehensive income (loss) |
( |
) |
( |
) |
( |
) |
( |
) |
( |
) |
( |
) | ||||||||||||||||||||||||||
Allocation of prior period loss |
( |
) | ||||||||||||||||||||||||||||||||||||
Capital Increase |
15.1 |
( |
) | |||||||||||||||||||||||||||||||||||
Capital Increase Calyxt |
( |
) | ( |
) | ( |
) | ||||||||||||||||||||||||||||||||
Exercise of share warrants, employee warrants and stock options |
16 |
|||||||||||||||||||||||||||||||||||||
Non-cash stock-based compensation expense |
16 |
|||||||||||||||||||||||||||||||||||||
Other movements |
( |
) | ||||||||||||||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||
As of December 31, 2019 |
( |
) |
( |
) |
( |
) |
||||||||||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||
As of January 1, 2020 |
( |
) |
( |
) |
( |
) |
||||||||||||||||||||||||||||||||
Net Loss |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||||||||||||||||||||||||
Other comprehensive income (loss) |
( |
) | ||||||||||||||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||
Total comprehensive income (loss) |
( |
) |
( |
) |
( |
) |
( |
) |
( |
) | ||||||||||||||||||||||||||||
Allocation of prior period loss |
( |
) | ||||||||||||||||||||||||||||||||||||
Exercise of stock options Calyxt (1) |
16 |
|||||||||||||||||||||||||||||||||||||
Capital Increase Calyxt (2) |
||||||||||||||||||||||||||||||||||||||
Transaction with subsidiaries |
( |
) | ( |
) | ||||||||||||||||||||||||||||||||||
Exercise of share and employee warrants / stock-options Cellectis |
16 |
Non-cash stock-based compensation expense |
16 |
|||||||||||||||||||||||||||||||||||||
Other movements |
( |
) | ||||||||||||||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||
As of December 31, 2020 |
( |
) |
( |
) |
( |
) |
||||||||||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||
As of January 1, 2021 |
( |
) |
( |
) |
( |
) |
||||||||||||||||||||||||||||||||
Net Loss |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||||||||||||||||||||||||
Other comprehensive income (loss) |
( |
) |
— |
( |
) | ( |
) | ( |
) | |||||||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||
Total comprehensive income (loss) |
( |
) |
( |
) |
( |
) |
( |
) |
( |
) | ||||||||||||||||||||||||||||
Allocation of prior period loss |
( |
) | ||||||||||||||||||||||||||||||||||||
Exercise of stock options and capital increase Calyxt (1) |
||||||||||||||||||||||||||||||||||||||
Capital Increase Cellectis (ATM) |
||||||||||||||||||||||||||||||||||||||
Transaction costs (3) |
( |
) | ( |
) | ( |
) | ||||||||||||||||||||||||||||||||
Transaction with subsidiaries |
( |
) | ( |
) | ||||||||||||||||||||||||||||||||||
Exercise of share warrants, employee warrants, stock-options and free-shares vesting Cellectis |
16 |
( |
) | |||||||||||||||||||||||||||||||||||
Non-cash stock-based compensation expense |
16 |
|||||||||||||||||||||||||||||||||||||
Other movements |
( |
) | ||||||||||||||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||
As of December 31, 2021 |
( |
) |
( |
) |
( |
) |
||||||||||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) | Corresponds to the impact of Calyxt stock options exercises during the period. |
(2) | On October 20, 2020, Calyxt entered into definitive agreements with institutional investors for the purchase and sale of SEC-registered, direct offering. The financing resulted in gross proceeds of $ |
(3) | These costs correspond to the issuance costs related to Cellectis’ At-The-Market |
• | IFRS Interpretation Committee Decision on configuration or Customization Costs in a Cloud Computing Arrangement (IAS 38 Intangible Assets) (published on April 27, 2021). See note 5. |
• | Interest Rate Benchmark Reform – Phase 2: Amendments to IFRS 9, IAS 39, IFRS 7, IFRS 4 and IFRS 16. The amendments provide temporary reliefs which address the financial reporting effects when an interbank offered rate (IBOR) is replaced with an alternative nearly risk-free interest rate (RFR). |
• | Amendments to IFRS 16 Leases: COVID-19-Related |
• | IFRS Interpretation Committee Decision Attributing Benefit to Periods of Service (IAS 19) (published on May 24, 2021). |
• | Amendments to IAS 37 – Onerous Contracts: Cost of Fulfilling a Contract (Effective for the accounting periods as of January 1, 2022) |
• | Amendments to IAS 16 – Property, Plant and Equipment: Proceeds before Intended Use (Effective for the accounting periods as of January 1, 2022) |
• | Amendments to IFRS 3 – Reference to the Conceptual Framework (Effective for the accounting periods as of January 1, 2022) |
• | IFRS 9 Financial Instruments – Fees in the ’10 per cent’ Test for Derecognition of Financial Liabilities (Effective for the accounting periods as of January 1, 2022) |
• | IFRS 17 – Insurance Contracts (Effective for the accounting periods as of January 1, 2023) |
• | Amendments to IAS 8 – Definition of Accounting Estimates (issued on 12 February 2021 and Effective for the accounting periods as of January 1, 2023) |
• | Amendments to IAS 1 and IFRS Practice Statement 2 –Disclosure of Accounting Policies (Effective for the accounting periods as of January 1, 2023) |
• | Amendments to IAS 1 – Classification of Liabilities as Current or Non-current (Effective for the accounting periods as of January 1, 2023) |
• | Amendments to IAS 12 – Income Taxes: Deferred Tax related to Assets and Liabilities arising from a Single Transaction (issued on 8 May 2021 and Effective for the accounting periods as of January 1, 2023) |
• | the differential between the average exchange rate and the period end rates applied to the cash flows of the period; |
• | the differential between the opening exchange rates and the period end exchanges rate applied on our opening cash and cash equivalents balance denominated in dollars; and |
• | the foreign exchange rate impact of the conversion of the financial statements of our US subsidiaries. |
• | Revenue Recognition: Collaboration Agreements and Licenses, Sales of Products and Services (Note 3.1) |
• | Research Tax Credit (Note 3.1) |
• | Share-Based Compensation (Note 16) |
• | Provisions for risks and charges (Note 18) |
For the year ended December 31, |
||||||||||||
2019 |
2020 |
2021 |
||||||||||
$ in thousands |
||||||||||||
From France |
||||||||||||
From USA |
||||||||||||
|
|
|
|
|
|
|||||||
Revenues |
||||||||||||
|
|
|
|
|
|
|||||||
Research tax credit |
||||||||||||
Subsidies and other (1) |
||||||||||||
|
|
|
|
|
|
|||||||
Other income |
||||||||||||
|
|
|
|
|
|
|||||||
Total revenues and other income |
||||||||||||
|
|
|
|
|
|
(1) | For the year ended December 2021, this includes only Calyxt’s PPP loan, which has been forgiven and recognized as other income in April 2021, as disclosed in note 12.1. |
For the year ended December 31, |
||||||||||||
2019 |
2020 |
2021 |
||||||||||
$ in thousands |
||||||||||||
Recognition of previously deferred upfront payments |
||||||||||||
Other revenues from collaboration agreements |
||||||||||||
|
|
|
|
|
|
|||||||
Collaboration agreements |
||||||||||||
|
|
|
|
|
|
|||||||
Licenses |
||||||||||||
Products & services |
||||||||||||
|
|
|
|
|
|
|||||||
Total revenues |
||||||||||||
|
|
|
|
|
|
For the year ended December 31, |
||||||||||||
2019 |
2020 |
2021 |
||||||||||
$ in thousands |
||||||||||||
Cost of revenue |
||||||||||||
Cost of goods sold |
( |
) | ( |
) | ( |
) | ||||||
Royalty expenses |
( |
) | ( |
) | ( |
) | ||||||
|
|
|
|
|
|
|||||||
Cost of revenue |
( |
) |
( |
) |
( |
) | ||||||
|
|
|
|
|
|
For the year ended December 31, |
||||||||||||
2019 |
2020 |
2021 |
||||||||||
|
|
|
||||||||||
$ in thousands |
||||||||||||
Research and development expenses |
||||||||||||
Wages and salaries |
( |
) | ( |
) | ( |
) | ||||||
Social charges on stock option grants |
( |
) | ( |
) | ( |
) | ||||||
Non-cash stock-based compensation expense |
( |
) | ( |
) | ( |
) | ||||||
|
|
|
|
|
|
|||||||
Personnel expenses |
( |
) |
( |
) |
( |
) | ||||||
|
|
|
|
|
|
|||||||
Purchases and external expenses |
( |
) | ( |
) | ( |
) | ||||||
Other |
( |
) | ( |
) | ( |
) | ||||||
|
|
|
|
|
|
|||||||
Total research and development expenses |
( |
) |
( |
) |
( |
) | ||||||
|
|
|
|
|
|
For the year ended December 31, |
||||||||||||
2019 |
2020 |
2021 |
||||||||||
|
|
|
||||||||||
$ in thousands |
||||||||||||
Selling, general and administrative expenses |
||||||||||||
Wages and salaries |
( |
) | ( |
) | ( |
) | ||||||
Social charges on stock option grants |
( |
) | ( |
) | ( |
) | ||||||
Non-cash stock-based compensation expense |
( |
) | ( |
) | ( |
) | ||||||
|
|
|
|
|
|
|||||||
Personnel expenses |
( |
) |
( |
) |
( |
) | ||||||
|
|
|
|
|
|
|||||||
Purchases and external expenses |
( |
) | ( |
) | ( |
) | ||||||
Other |
( |
) | ( |
) | ( |
) | ||||||
|
|
|
|
|
|
|||||||
Total selling, general and administrative expenses |
( |
) |
( |
) |
( |
) | ||||||
|
|
|
|
|
|
For the year ended December 31, |
||||||||||||
2019 |
2020 |
2021 |
||||||||||
|
|
|
||||||||||
$ in thousands |
||||||||||||
Personnel expenses |
||||||||||||
Wages and salaries |
( |
) | ( |
) | ( |
) | ||||||
Social charges on free shares and stock option grants |
( |
) | ( |
) | ( |
) | ||||||
Non-cash stock-based compensation expense |
( |
) | ( |
) | ( |
) | ||||||
|
|
|
|
|
|
|||||||
Total personnel expenses |
( |
) |
( |
) |
( |
) | ||||||
|
|
|
|
|
|
• | Interest income from savings accounts and fixed term bank deposits; |
• | Interest expense from leases; |
• | Foreign exchange gain (loss) from transactions in foreign currencies; and |
• | Other financial income and expenses, mainly derived from fair value adjustments related to our financial assets and derivative instruments. |
For the year ended December 31, |
||||||||||||
2019 |
2020 |
2021 |
||||||||||
Interest income |
||||||||||||
Foreign exchange gain |
||||||||||||
Other financial revenues |
||||||||||||
|
|
|
|
|
|
|||||||
Total financial revenues |
||||||||||||
|
|
|
|
|
|
|||||||
Interest expenses |
( |
) | ( |
) | ( |
) | ||||||
Interest expenses for leases |
( |
) | ( |
) | ( |
) | ||||||
Foreign exchange loss |
( |
) | ( |
) | ( |
) | ||||||
Other financial expenses |
( |
) | ( |
) | ( |
) | ||||||
|
|
|
|
|
|
|||||||
Total financial expenses |
( |
) |
( |
) |
( |
) | ||||||
|
|
|
|
|
|
|||||||
Total |
( |
) |
||||||||||
|
|
|
|
|
|
For the year ended December 31, |
||||||||||||
2019 |
2020 |
2021 |
||||||||||
|
|
|
||||||||||
$ in thousands |
||||||||||||
Income (loss) before taxes from continuing operations |
( |
) | ( |
) | ( |
) | ||||||
Theoretical group tax rate |
% | % | % | |||||||||
|
|
|
|
|
|
|||||||
Theoretical tax benefit (expense) |
||||||||||||
|
|
|
|
|
|
|||||||
Increase/decrease in tax benefit arising from: |
||||||||||||
Permanent differences |
( |
) | ( |
) | ( |
) | ||||||
Research tax credit |
||||||||||||
Share-based compensation & other IFRS adjustments |
( |
) | ( |
) | ( |
) | ||||||
Non recognition of deferred tax assets related to tax losses and temporary differences |
( |
) | ( |
) | ( |
) | ||||||
Other differences |
||||||||||||
|
|
|
|
|
|
|||||||
Effective tax expense |
||||||||||||
|
|
|
|
|
|
|||||||
Effective tax rate |
% | % | % |
As of December 31, |
||||||||||||
2019 |
2020 |
2021 |
||||||||||
|
|
|
||||||||||
$ in thousands |
||||||||||||
Credits and net operating loss carryforwards |
||||||||||||
Pension commitments |
||||||||||||
Leases |
||||||||||||
Impairment of assets |
||||||||||||
Revenue recognition |
( |
) | — | |||||||||
Other |
( |
) | ||||||||||
Total unrecognized deferred tax assets, net |
( |
) | ( |
) | ( |
) |
• | The Chief Executive Officer; |
• | The Executive Vice President Strategic Initiatives; |
• | The Executive Vice President Global Quality (until March 31, 2021); |
• | The Senior Vice President Europe Technical Operations (until November 29, 2021); |
• | The Senior Vice President of US Manufacturing; |
• | The Chief Scientific Officer; |
• | The Chief Financial Officer (until December 2, 2021) (1); |
• | The General Counsel; |
• | The Chief Business Officer; |
• | The Chief Regulatory & Pharmaceutical Compliance Officer; |
• | The Chief Medical Officer; and |
• | The Chief Human Resources Officer. |
(1) | The new Chief Financial Officer was appointed on February 10, 2022. |
• | Therapeutics: T-cells product candidates (UCART) in the field of immuno-oncology (UCART) and (ii) gene-edited hematopoietic stem cells (HSC) product candidates in other therapeutic indications. These approaches are based on our core proprietary technologies. All these activities are supported by Cellectis S.A., Cellectis, Inc. and Cellectis Biologics, Inc. The operations of Cellectis S.A., the parent company, are presented entirely in the Therapeutics segment which also comprises research and development, management and support functions. |
• | Plants: ™ production system. It corresponds to the activity of our U.S.-based majority-owned subsidiary, Calyxt, which is currently based in Roseville, Minnesota. |
For the year ended December 31, 2019 |
For the year ended December 31, 2020 |
For the year ended December 31, 2021 |
||||||||||||||||||||||||||||||||||
($ in thousands) |
Plants |
Therapeutics |
Total reportable segments |
Plants |
Therapeutics |
Total reportable segments |
Plants |
Therapeutics |
Total reportable segments |
|||||||||||||||||||||||||||
External revenues |
||||||||||||||||||||||||||||||||||||
External other income |
||||||||||||||||||||||||||||||||||||
External revenues and other income |
||||||||||||||||||||||||||||||||||||
Cost of revenue |
( |
) | ( |
) | ( |
) | ( |
) | ( |
) | ( |
) | ( |
) | ( |
) | ( |
) | ||||||||||||||||||
Research and development expenses |
( |
) | ( |
) | ( |
) | ( |
) | ( |
) | ( |
) | ( |
) | ( |
) | ( |
) | ||||||||||||||||||
Selling, general and administrative expenses |
( |
) | ( |
) | ( |
) | ( |
) | ( |
) | ( |
) | ( |
) | ( |
) | ( |
) | ||||||||||||||||||
Other operating income and expenses |
( |
) | ( |
) | ( |
) | ( |
) | ( |
) | ||||||||||||||||||||||||||
Total operating expenses |
( |
) |
( |
) |
( |
) |
( |
) |
( |
) |
( |
) |
( |
) |
( |
) |
( |
) | ||||||||||||||||||
Operating income (loss) before tax |
( |
) |
( |
) |
( |
) |
( |
) |
( |
) |
( |
) |
( |
) |
( |
) |
( |
) | ||||||||||||||||||
Net financial gain (loss) |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||||||||||||||||||||||
Net income (loss) |
( |
) |
( |
) |
( |
) |
( |
) |
( |
) |
( |
) |
( |
) |
( |
) |
( |
) | ||||||||||||||||||
Non-controlling interests |
||||||||||||||||||||||||||||||||||||
Net income (loss) attributable to shareholders of Cellectis |
( |
) |
( |
) |
( |
) |
( |
) |
( |
) |
( |
) |
( |
) |
( |
) |
( |
) | ||||||||||||||||||
R&D non-cash stock-based expense attributable to shareholder of Cellectis |
||||||||||||||||||||||||||||||||||||
SG&A non-cash stock-based expense attributable to shareholder of Cellectis |
||||||||||||||||||||||||||||||||||||
Adjustment of share-based compensation attributable to shareholders of Cellectis |
||||||||||||||||||||||||||||||||||||
Adjusted net income (loss) attributable to shareholders of Cellectis |
( |
) |
( |
) |
( |
) |
( |
) |
( |
) |
( |
) |
( |
) |
( |
) |
( |
) | ||||||||||||||||||
Depreciation and amortization tangible and intangible assets |
( |
) | ( |
) | ( |
) | ( |
) | ( |
) | ( |
) | ( |
) | ( |
) | ( |
) | ||||||||||||||||||
Additions to tangible and intangible assets |
• | technical feasibility necessary for the completion of the development project; |
• | intention on our part to complete the project and to utilize it; |
• | capacity to utilize the intangible asset; |
• | proof of the probability of future economic benefits associated with the asset; |
• | availability of the technical, financial, and other resources for completing the project; and |
• | reliable evaluation of the development expenses. |
• | Software: from |
• | Patents: amortized from acquisition until legal protection expires, maximum of |
$ in thousands |
Software and Patents |
Assets under construction |
Total |
|||||||||
Net book value as of January 1, 2019 |
||||||||||||
Additions to intangible assets |
( |
) | ||||||||||
Disposal of intangible assets |
( |
) | ( |
) | ||||||||
Reclassification |
||||||||||||
Depreciation expense |
( |
) | ( |
) | ||||||||
Translation adjustments |
( |
) | ( |
) | ( |
) | ||||||
Net book value as of December 31, 2019 |
||||||||||||
Gross value at end of period |
||||||||||||
Accumulated depreciation and impairment at end of period |
( |
) | ( |
) | ||||||||
Net book value as of January 1, 2020 |
||||||||||||
Additions to intangible assets |
( |
) | ||||||||||
Disposal of intangible assets |
||||||||||||
Reclassification |
||||||||||||
Depreciation expense |
( |
) | ( |
) | ||||||||
Translation adjustments |
||||||||||||
Net book value as of December 31, 2020 |
||||||||||||
Gross value at end of period |
||||||||||||
Accumulated depreciation and impairment at end of period |
( |
) | ( |
) | ||||||||
Net book value as of January 1, 2021 |
||||||||||||
Additions to intangible assets |
||||||||||||
Disposal of intangible assets |
( |
) | ( |
) | ||||||||
Reclassification |
( |
) | ||||||||||
Depreciation expense |
( |
) | ( |
) | ||||||||
Translation adjustments |
( |
) | ( |
) | ( |
) | ||||||
Net book value as of December 31, 2021 |
||||||||||||
Gross value at end of period |
||||||||||||
Accumulated depreciation and impairment at end of period |
( |
) | ( |
) |
• | an asset representing a right of use of the asset leased during the lease term of the contract “right-of-use”; |
• | a liability related to the payment obligation “lease debt”. |
• | the amount of the initial measurement of the lease liability, to which is added, if applicable, any lease payments made at or before the commencement date, less any lease incentives received; |
• | where relevant, any initial direct costs incurred by the lessee for the conclusion of the contract. These are incremental costs which would not have been incurred if the contract had not been concluded; and |
• | estimated costs for restoration of the leased asset according to the terms of the contract. |
• | fixed payments (including in-substance fixed payments meaning that even if they are variable in form, they are in-substance unavoidable); |
• | variable lease payments that depend on an index or a rate, initially measured using the index or the rate in force at the lease commencement date; amounts expected to be payable by the lessee under residual value guarantees; and |
• | payments of penalties for terminating the lease, if the lease term reflects the lessee exercising an option to terminate the lease. |
• | the liability is increased by the accrued interests resulting from the discounting of the lease liability, at the beginning of the lease period; and |
• | payments made are deducted. |
• |
the occurrence of a change in the lease term or a modification related to the assessment of the reasonably certain nature (or not) of the exercise of an option, |
• |
a remeasurement linked to residual value guarantees, |
• |
the occurrence of an adjustment to the rates and indices according to which the rents are calculated when rent adjustments occur. |
Building |
Office and laboratory equipment |
Total |
||||||||||
$ in thousands |
||||||||||||
Net book value as of January 1, 2020 |
||||||||||||
Additions to right-of-use assets |
||||||||||||
Depreciation expense |
( |
) | ( |
) | ( |
) | ||||||
Translation adjustments |
( |
) | ||||||||||
Net book value as of December 31, 2020 |
||||||||||||
Gross value at end of period |
||||||||||||
Accumulated depreciation at end of period |
( |
) | ( |
) | ( |
) | ||||||
Net book value as of January 1, 2021 |
||||||||||||
Additions to right-of-use assets |
( |
) | ||||||||||
Depreciation expense |
( |
) | ( |
) | ( |
) | ||||||
Translation adjustments |
( |
) | ( |
) | ( |
) | ||||||
Net book value as of December 31, 2021 |
||||||||||||
Gross value at end of period |
||||||||||||
Accumulated depreciation at end of period |
( |
) | ( |
) | ( |
) |
• | Buildings and other outside improvements | ||
• | Leasehold improvements | ||
• | Office furniture | ||
• | Laboratory equipment | ||
• | Office equipment | ||
• | IT equipment |
Lands and Buildings |
Technical equipment |
Fixtures, fittings and other equipment |
Assets under construction |
Total |
||||||||||||||||
$ in thousands |
||||||||||||||||||||
Net book value as of January 1, 2019 |
||||||||||||||||||||
Additions to tangible assets |
||||||||||||||||||||
Disposal of tangible assets |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||||||
Reclassification |
( |
) | ( |
) | ||||||||||||||||
Depreciation expense |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||||||
Translation adjustments |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||||||
Net book value as of December 31, 2019 |
||||||||||||||||||||
Gross value at end of period |
||||||||||||||||||||
Accumulated depreciation and impairment at end of period |
( |
) | ( |
) | ( |
) | ( |
) | ( |
) | ||||||||||
Net book value as of January 1, 2020 |
||||||||||||||||||||
Additions to tangible assets |
||||||||||||||||||||
Disposal of tangible assets |
( |
) | ( |
) | ||||||||||||||||
Reclassification |
( |
) | ( |
) | ||||||||||||||||
Depreciation expense |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||||||
Translation adjustments |
||||||||||||||||||||
Net book value as of December 31, 2020 |
||||||||||||||||||||
Gross value at end of period |
||||||||||||||||||||
Accumulated depreciation and impairment at end of period |
( |
) | ( |
) | ( |
) | ( |
) | ( |
) | ||||||||||
Net book value as of January 1, 2021 |
||||||||||||||||||||
Additions to tangible assets |
||||||||||||||||||||
Disposal of tangible assets |
( |
) | ( |
) | ||||||||||||||||
Reclassification |
( |
) | ( |
) | ( |
) | ||||||||||||||
Depreciation expense |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||||||
Translation adjustments |
( |
) | ( |
) | ( |
) | ( |
) | ( |
) | ||||||||||
Net book value as of December 31, 2021 |
||||||||||||||||||||
Gross value at end of period |
||||||||||||||||||||
Accumulated depreciation and impairment at end of period |
( |
) | ( |
) | ( |
) | ( |
) | ( |
) |
• | financial assets measured at amortized cost or; |
• | financial assets measured at fair value through profit or loss. |
Accounting category |
Book value on the statement of financial position |
Fair Value |
||||||||||||||
2020 |
Fair value through profit and loss |
Amortized cost |
||||||||||||||
$ in thousands |
||||||||||||||||
Financial assets |
||||||||||||||||
Non-current financial assets |
— | |||||||||||||||
Trade receivables |
— | |||||||||||||||
Subsidies receivables |
— | |||||||||||||||
Current financial assets |
— | |||||||||||||||
Cash and cash equivalents |
— | |||||||||||||||
Total financial assets |
||||||||||||||||
Financial liabilities |
||||||||||||||||
Non-current lease debt |
— | |||||||||||||||
Other non-current financial liabilities |
— | |||||||||||||||
Current lease debts |
— | |||||||||||||||
Trade payables |
— | |||||||||||||||
Other current liabilities |
— | |||||||||||||||
Total financial liabilities |
— |
|||||||||||||||
Accounting category |
Book value on the statement of financial position |
Fair Value |
||||||||||||||
2021 |
Fair value through profit and loss |
Amortized cost |
||||||||||||||
$ in thousands |
||||||||||||||||
Financial assets |
||||||||||||||||
Non-current financial assets |
||||||||||||||||
Trade receivables |
||||||||||||||||
Subsidies receivables |
||||||||||||||||
Current financial assets |
||||||||||||||||
Cash and cash equivalents |
||||||||||||||||
Total financial assets |
||||||||||||||||
Financial liabilities |
||||||||||||||||
Non-current lease debts |
||||||||||||||||
Non-current financial liabilities |
||||||||||||||||
Current lease debts |
||||||||||||||||
Current financial liabilities |
— | |||||||||||||||
Trade payables |
||||||||||||||||
Other current liabilities |
||||||||||||||||
Total financial liabilities |
||||||||||||||||
As of December 31, |
As of December 31, |
|||||||
2020 |
2021 |
|||||||
$ in thousands |
||||||||
Trade receivables |
||||||||
Valuation allowance |
( |
) | ( |
) | ||||
Total net value of trade receivables |
||||||||
As of December 31, |
As of December 31, |
|||||||
2020 |
2021 |
|||||||
$ in thousands |
||||||||
Research tax credit |
||||||||
Total subsidies receivables |
||||||||
As of December 31, |
As of December 31, |
|||||||
2020 |
2021 |
|||||||
$ in thousands |
||||||||
VAT receivables |
||||||||
Prepaid expenses and other prepayments |
||||||||
Tax and social receivables |
||||||||
Deferred expenses and other current assets |
||||||||
Total other current assets |
||||||||
As of December 31, 2020 |
Carrying amount |
Unrealized Gains/(Losses) |
Estimated fair value |
|||||||||
$ in thousands |
||||||||||||
Current financial assets |
— | |||||||||||
Cash and cash equivalents |
— | |||||||||||
Current financial assets and cash and cash equivalents |
— |
|||||||||||
As of December 31, 2021 |
Carrying amount |
Unrealized Gains/(Losses) |
Estimated fair value |
|||||||||
$ in thousands |
||||||||||||
Current financial assets |
— | |||||||||||
Cash and cash equivalents |
— | |||||||||||
Current financial assets and cash and cash equivalents |
— |
|||||||||||
• |
Financial assets including embedded derivatives for which Cellectis elected to designate at fair value through profit or loss; |
• |
Financial assets managed on a fair value basis; and |
• |
Derivative instruments that are not documented in hedging relationships. |
As of December 31, |
As of December 31, |
|||||||
2020 |
2021 |
|||||||
$ in thousands |
||||||||
Cash and bank accounts |
||||||||
Money market funds |
||||||||
Fixed bank deposits |
||||||||
Total cash and cash equivalents |
||||||||
As of December 31, |
As of December 31, |
|||||||
2020 |
2021 |
|||||||
$ in thousands |
||||||||
Lease debts |
||||||||
State Guaranteed loan « PGE » |
||||||||
PPP loan |
— | |||||||
Non-current financial liabilities |
||||||||
Total non-current financial liabilities and non-current lease debts |
||||||||
Lease debts |
||||||||
State Guaranteed loan « PGE » |
— | |||||||
Current financial liabilities |
— | |||||||
Total current financial liabilities and current lease debts |
||||||||
Trade payables |
||||||||
Other current liabilities |
||||||||
Total Financial liabilities |
||||||||
Balance as of December 31, 2021 |
Book Value |
Less than One Year |
One to Five Years |
More than Five Years |
||||||||||||
$ in thousands |
||||||||||||||||
Lease debts |
||||||||||||||||
Financial liabilities |
||||||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Financial liabilities |
||||||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Trade payables |
— | — | ||||||||||||||
Other current liabilities |
— | — | ||||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total financial liabilities |
||||||||||||||||
|
|
|
|
|
|
|
|
As of December 31, |
As of December 31, |
|||||||
2020 |
2021 |
|||||||
$ in thousands |
||||||||
VAT Payables |
||||||||
Accruals for personnel related expenses |
||||||||
Other |
||||||||
|
|
|
|
|||||
Total |
||||||||
|
|
|
|
As of December 31, 2020 |
As of December 31, 2021 |
|||||||
$ in thousands |
||||||||
Deferred revenues and contract liabilities |
||||||||
|
|
|
|
|||||
Total Deferred revenue and contract liabilities |
||||||||
|
|
|
|
Nature of the Transactions |
Share Capital |
Share premium |
Number of shares |
Nominal value |
||||||||||||
$ in thousands |
in $ |
|||||||||||||||
Balance as of J anuary 1, 2019 |
||||||||||||||||
Capital Increase |
— | |||||||||||||||
Exercise of share warrants, employee warrants and stock options |
— | |||||||||||||||
Non-cash stock-based compensation expense |
— | — | — | |||||||||||||
Other movements |
— | — | — | |||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Balance as of December 31, 2019 |
||||||||||||||||
Exercise of share warrants, employee warrants and stock options |
— | |||||||||||||||
Non-cash stock-based compensation expense |
— | — | — | |||||||||||||
Other movements |
— | ( |
) | — | — | |||||||||||
|
|
|
|
|
|
|
|
|||||||||
Balance as of December 31, 2020 |
||||||||||||||||
Capital increase (ATM) |
||||||||||||||||
Exercise of share warrants, employee warrants and stock options |
— | |||||||||||||||
Non-cash stock-based compensation expense |
— | — | — | |||||||||||||
Transaction costs |
— | ( |
) | |||||||||||||
Other movements |
— | ( |
) | — | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Balance as of December 31, 2021 |
• | During the full year ended December 31, 2021, At-The-Market non-employee warrants, $ |
• | During the full year ended December 31, 2020, |
• | During the full year ended December 31, 2019, |
• | |
• | |
• | |
Date |
Type |
Number of warrants/shares outstanding as of 01/01/2021 |
Number of warrants/shares granted |
Number of warrants/shares vested/exercised |
Number of warrants/shares voided |
Number of warrants/shares outstanding as of 12/31/2021 |
Maximum of shares to be issued |
Number of warrants/shares exercisable as of 12/31/2021 |
Strike price per share in euros |
|||||||||||||||||||||||||
— | — | |||||||||||||||||||||||||||||||||
— | — | — | ||||||||||||||||||||||||||||||||
— | — | — | ||||||||||||||||||||||||||||||||
— | — | — | ||||||||||||||||||||||||||||||||
— | — | |||||||||||||||||||||||||||||||||
— | — | — | ||||||||||||||||||||||||||||||||
— | ||||||||||||||||||||||||||||||||||
— | — | |||||||||||||||||||||||||||||||||
— | ||||||||||||||||||||||||||||||||||
— | — | — | ||||||||||||||||||||||||||||||||
— | ||||||||||||||||||||||||||||||||||
— | — | |||||||||||||||||||||||||||||||||
— | — | — | — | — | ||||||||||||||||||||||||||||||
— | ||||||||||||||||||||||||||||||||||
— | — | — | — | — | ||||||||||||||||||||||||||||||
— | — | — | — | — | ||||||||||||||||||||||||||||||
— | — | — | ||||||||||||||||||||||||||||||||
— | — | — | — | |||||||||||||||||||||||||||||||
— | — | — | — | |||||||||||||||||||||||||||||||
— | — | — | — | |||||||||||||||||||||||||||||||
— | — | — | — | |||||||||||||||||||||||||||||||
— | — | — | — | |||||||||||||||||||||||||||||||
— | — | — | ||||||||||||||||||||||||||||||||
— | — | — | ||||||||||||||||||||||||||||||||
— | — | — | ||||||||||||||||||||||||||||||||
— | — | — | — | |||||||||||||||||||||||||||||||
— |
— |
— |
||||||||||||||||||||||||||||||||
— |
— |
|||||||||||||||||||||||||||||||||
— |
— |
— |
— |
— |
— |
|||||||||||||||||||||||||||||||
— |
— |
— |
— |
— |
||||||||||||||||||||||||||||||
— |
— |
— |
||||||||||||||||||||||||||||||||
— |
— |
— |
||||||||||||||||||||||||||||||||
— |
— |
— |
||||||||||||||||||||||||||||||||
— |
— |
— |
— |
|||||||||||||||||||||||||||||||
— |
— |
— |
— |
|||||||||||||||||||||||||||||||
— |
— |
— |
||||||||||||||||||||||||||||||||
— |
— |
— |
— |
|||||||||||||||||||||||||||||||
— |
— |
— |
||||||||||||||||||||||||||||||||
— |
— |
— |
||||||||||||||||||||||||||||||||
— |
— |
— |
— |
|||||||||||||||||||||||||||||||
— |
— |
— |
— |
|||||||||||||||||||||||||||||||
— |
— |
— |
||||||||||||||||||||||||||||||||
— |
— |
— |
— |
|||||||||||||||||||||||||||||||
— |
— |
— |
||||||||||||||||||||||||||||||||
— |
— |
— |
||||||||||||||||||||||||||||||||
— |
— |
— |
— |
|||||||||||||||||||||||||||||||
— |
— |
— |
— |
|||||||||||||||||||||||||||||||
— |
— |
— |
— |
|||||||||||||||||||||||||||||||
— |
— |
— |
— |
|||||||||||||||||||||||||||||||
— |
— |
— |
— |
|||||||||||||||||||||||||||||||
— |
— |
— |
— |
|||||||||||||||||||||||||||||||
Total |
• | In 2021, our subsidiary Calyxt granted stock options, restricted stock unit and performance stock unit in Calyxt representing as of December 31, 2021 a |
• | In 2020, our subsidiary Calyxt granted stock options, restricted stock unit and performance stock unit in Calyxt representing as of December 31, 2020 a |
• | In 2019, our subsidiary Calyxt granted stock options, restricted stock unit and performance stock unit in Calyxt representing as of December 31, 2019 a |
CALYXT |
||||||||
2020 |
2021 |
|||||||
$ in thousands |
||||||||
Revenue |
||||||||
Net Profit (Loss) |
( |
) | ( |
) | ||||
Net Profit (Loss) attributable to NCI |
( |
) |
( |
) | ||||
Other comprehensive income |
( |
) | ( |
) | ||||
Total comprehensive income |
( |
) | ( |
) | ||||
Total comprehensive income attributable to NCI |
( |
) |
( |
) | ||||
Current assets |
||||||||
Non-current assets |
||||||||
Current liabilities |
||||||||
Non-current liabilities |
||||||||
Net assets |
||||||||
Net assets attributable to NCI |
||||||||
2019 |
2020 |
2021 | ||||
Weighted-Average fair values of stock options granted |
||||||
Assumptions: |
||||||
Risk-free interest rate |
- |
|||||
Share entitlement per options |
||||||
Exercise price |
||||||
Grant date share fair value |
||||||
Expected volatility |
||||||
Expected term (in years) |
||||||
Vesting conditions |
||||||
Vesting period |
Options Exercisable |
Weighted- Average Exercise Price Per Share |
Options Outstanding |
Weighted- Average Exercise Price Per Share |
Remaining Average Useful Life |
||||||||||||||||
Balance as of December 31, 2019 |
€ |
€ |
||||||||||||||||||
Granted |
— | — | € | |||||||||||||||||
Exercised |
— | — | ( |
) | € | |||||||||||||||
Forfeited or Expired |
— | — | ( |
) | € | |||||||||||||||
Balance as of December 31, 2020 |
€ |
€ |
||||||||||||||||||
Granted |
€ | |||||||||||||||||||
Exercised |
( |
) | € | |||||||||||||||||
Forfeited or Expired |
( |
) | € | |||||||||||||||||
Balance as of December 31, 2021 |
€ |
€ |
2016 |
2017 | |||
Weighted-Average fair values of warrants granted |
||||
Assumptions: |
||||
Risk-free interest rate |
||||
Share entitlement per options |
||||
Exercise price |
||||
Grant date share fair value |
||||
Expected volatility |
||||
Expected term (in years) |
||||
Vesting conditions |
||||
Vesting period |
Warrants Exercisable |
Weighted- Average Exercise |
Warrants Outstanding |
Weighted- Average Exercise |
Remaining Average Useful |
||||||||||||||||
Balance as of December 31, 2019 |
€ |
€ |
||||||||||||||||||
Granted |
||||||||||||||||||||
Exercised |
( |
) | € | |||||||||||||||||
Forfeited or Expired |
||||||||||||||||||||
Balance as of December 31, 2020 |
€ |
€ |
||||||||||||||||||
Granted |
||||||||||||||||||||
Exercised |
( |
) | € | |||||||||||||||||
Forfeited or Expired |
||||||||||||||||||||
Balance as of December 31, 2021 |
€ |
€ |
Number of Free shares Outstanding |
Weighted- Average Grant Date Fair Value |
|||||||
Unvested balance at December 31, 2019 |
€ | |||||||
Granted (1) |
€ | |||||||
Vested |
( |
) | € | |||||
Cancelled |
( |
) | € | |||||
Unvested balance at December 31, 2020 |
€ | |||||||
Granted |
€ | |||||||
Vested |
( |
) | € | |||||
Cancelled |
( |
) | € | |||||
Unvested balance at December 31, 2021 |
€ |
(1) | non-market performance vesting conditions and with a minimum vesting period of non-market performance vesting conditions. These free shares have been granted to a large number of our employees. |
2019 |
2020 |
2021 |
||||||||||
Weighted-Average fair values of stock options granted |
$ |
$ |
$ |
|||||||||
Assumptions: |
||||||||||||
Risk-free interest rate |
% - |
% - |
% - |
|||||||||
Share entitlement per options |
||||||||||||
Exercise price |
$ |
$ |
$ |
|||||||||
Grant date share fair value |
$ |
$ |
$ |
|||||||||
Expected volatility |
% - |
|||||||||||
Expected term (in years) |
||||||||||||
Vesting conditions |
||||||||||||
Vesting period |
Options Exercisable |
Weighted- Average Exercise Price Per Share |
Options Outstanding |
Weighted- Average Exercise Price Per Share |
Remaining Average Useful Life |
||||||||||||||||
Balance as of December 31, 2019 |
$ |
$ |
||||||||||||||||||
Granted |
$ | |||||||||||||||||||
Exercised |
( |
) | $ | |||||||||||||||||
Forfeited or Expired |
( |
) | $ | |||||||||||||||||
Balance as of December 31, 2020 |
$ |
$ |
||||||||||||||||||
Granted |
$ | |||||||||||||||||||
Exercised |
( |
) | $ | |||||||||||||||||
Forfeited or Expired |
( |
) | $ | |||||||||||||||||
Balance as of December 31, 2021 |
$ |
$ |
Number of Restricted Stock Units Outstanding |
Weighted-Average Grant Date Fair Value |
|||||||
Unvested balance at December 31, 2019 |
$ |
|||||||
Granted |
$ | |||||||
Vested |
( |
) | $ | |||||
Cancelled |
( |
) | $ | |||||
Unvested balance at December 31, 2020 |
$ |
|||||||
Granted |
$ | |||||||
Vested |
( |
) | $ | |||||
Cancelled |
( |
) | $ | |||||
Unvested balance at December 31, 2021 |
$ |
Date of grant |
06/28/2019 |
|||
Estimated fair values of performance stock units granted |
$ | |||
Assumptions: |
||||
Risk-free interest rate |
% | |||
Expected volatility |
% | |||
Expected term (in years) |
Date of grant |
07/01/2021 |
|||
Estimated fair values of performance stock units granted: |
||||
At least $12 per share |
$ | |||
At least $15 per share |
$ | |||
At least $20 per share |
$ | |||
Assumptions: |
||||
Expected term (in years) |
||||
Expected volatility |
% | |||
Risk-free interest rate |
% |
Number of Performance Stock Units Outstanding |
||||
Unvested balance at December 31, 2019 |
||||
Granted |
||||
Vested |
||||
Cancelled |
||||
Unvested balance at December 31, 2020 |
||||
Granted |
||||
Vested |
||||
Cancelled |
( |
) | ||
Unvested balance at December 31, 2021 |
For the year ended December 31, |
||||||||||||
2019 |
2020 |
2021 |
||||||||||
Net income (loss) attributable to shareholders of Cellectis ($ in thousands) |
( |
) | ( |
) | ( |
) | ||||||
Adjusted weighted average number of outstanding shares, used to calculate both basic and diluted net result per share |
||||||||||||
Basic / Diluted net income (loss) per share attributable to shareholders of Cellectis |
||||||||||||
Basic net income (loss) attributable to shareholders of Cellectis per share ($ /share) |
( |
) | ( |
) | ( |
) | ||||||
Diluted net income (loss) attributable to shareholders of Cellectis per share ($ /share) |
( |
) | ( |
) | ( |
) |
• | When the entity can no longer withdraw the offer of those benefits; and |
• | When the entity recognizes costs for a restructuring that is within the scope of IAS 37 Provisions and involves the payment of termination benefits. |
01/01/2020 |
Additions |
Amounts used during the period |
Reversals |
OCI |
12/31/2020 |
|||||||||||||||||||
$ in thousands |
||||||||||||||||||||||||
Pension |
||||||||||||||||||||||||
Loss on contract |
( |
) | ||||||||||||||||||||||
Employee litigation and severance |
( |
) | ( |
) | ||||||||||||||||||||
Commercial litigation |
( |
) | ( |
) | ||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
Total |
( |
) |
( |
) |
||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
Non-current provisions |
||||||||||||||||||||||||
Current provisions |
( |
) | ( |
) |
01/01/2021 |
Additions |
Amounts used during the period |
Reversals |
OCI |
12/31/2021 |
|||||||||||||||||||
$ in thousands |
||||||||||||||||||||||||
Pension |
( |
) | ||||||||||||||||||||||
Employee litigation and severance |
( |
) | ( |
) | ( |
) | ||||||||||||||||||
Commercial litigation |
( |
) | ( |
) | ( |
) | ||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
Total |
( |
) |
( |
) |
( |
) |
||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
Non-current provisions |
( |
) | ||||||||||||||||||||||
Current provisions |
( |
) | ( |
) | ( |
) |
• |
Seniority conditions: the employee must be entitled to an indemnity of 8 working months against one year before. |
• |
Calculation of the allowance: 1/4 of a month of salary per year of seniority up to 10 years, against 1/5 before, and no change beyond the 11th year. |
2019 |
2020 |
2021 | ||||
% social security contributions |
||||||
Salary increases |
||||||
Discount rate |
||||||
Terms of retirement |
||||||
Retirement age |
$ in thousands |
||||
As of January 1, 2019 |
( |
) | ||
|
|
|||
Current service cost |
( |
) | ||
Interest cost |
( |
) | ||
Benefit paid |
||||
Actuarial gains and losses |
( |
) | ||
Reclassification/CTA |
||||
As of December 31, 2019 |
( |
) | ||
|
|
|||
Current service cost |
( |
) | ||
Interest cost |
( |
) | ||
Benefit paid |
||||
Actuarial gains and losses |
( |
) | ||
Reclassification/CTA |
( |
) | ||
As of December 31, 2020 |
( |
) | ||
|
|
|||
Current service cost |
( |
) | ||
Interest cost |
( |
) | ||
Benefit paid |
||||
Actuarial gains and losses |
||||
Reclassification/CTA |
||||
As of December 31, 2021 |
( |
) | ||
|
|
As of December 31, 2021 |
Total |
Less than 1 year |
1 - 3 years |
3 - 5 years |
More than 5 years |
|||||||||||||||
$ in thousands |
||||||||||||||||||||
License and collaboration agreements |
||||||||||||||||||||
Clinical & Research and Development agreements |
— | — | — | |||||||||||||||||
IT licensing agreements |
— | — | ||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||
Total commitments |
||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
CELLECTIS S.A. | ||
/s/ André Choulika | ||
By: |
André Choulika | |
Title: |
Chief Executive Officer |