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 |
Title of each class |
Trading Symbol |
Name of each exchange on which registered | ||
* | Not for trading, but only in connection with the registration of the American Depositary Shares. |
Accelerated filer ☐ |
Non-accelerated filer ☐ |
Emerging growth company |
U.S. GAAP ☐ | by the International Accounting Standards Board ☒ |
Other ☐ |
Auditor Firm ID: |
Auditor Name: Deloitte Statsautoriseret |
Auditor Location: | ||||||
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II-1 |
• | the timing or likelihood of regulatory filings and approvals for our product candidates; |
• | our expectations regarding the commercial availability of TransCon hGH, known by its brand name SKYTROFA (lonapegsomatropin-tcgd), in the United States and related patient support services; |
• | the commercialization of TransCon hGH and our other product candidates, if approved; |
• | our commercialization, marketing and manufacturing capabilities of TransCon Growth Hormone, or TransCon hGH, and our other product candidates and associated devices; |
• | the scope, progress, results and costs of developing our product candidates or any other future product candidates, and conducting preclinical studies and clinical trials; |
• | our pursuit of oncology as our second of three independent therapeutic areas of focus, and our development of a pipeline of product candidates related to oncology; |
• | our expectations regarding the potential market size and the size of the patient populations for TransCon hGH and our other product candidates, if approved for commercial use; |
• | our expectations regarding the potential advantages of TransCon hGH and our other product candidates over existing therapies; |
• | our ability to enter into new collaborations; |
• | our expectations with regard to the ability to develop additional product candidates using our TransCon technologies and file Investigational New Drug Applications, or INDs, or similar for such product candidates; |
• | our expectations with regard to the ability to seek expedited regulatory approval pathways for our product candidates, including the potential ability to rely on the parent drug’s clinical and safety data with regard to our product candidates; |
• | our expectations with regard to our current and future collaboration partners to pursue the development of our product candidates and file INDs or similar for such product candidates; |
• | our development plans with respect to TransCon hGH and our other product candidates; |
• | our ability to develop, acquire and advance product candidates into, and successfully complete, clinical trials; |
• | the implementation of our business model and strategic plans for our business, TransCon hGH and our other product candidates and technologies, including global commercialization strategies; |
• | the scope of protection we are able to establish and maintain for intellectual property rights covering TransCon hGH and our other product candidates; |
• | estimates of our expenses, future revenue, capital requirements, our needs for additional financing and our ability to obtain additional capital; |
• | our financial performance; |
• | developments and projections relating to our market conditions, competitors and industry; and |
• | the potential effects on our business of the worldwide COVID-19 pandemic. |
• | The global pandemic caused by COVID-19 could materially adversely impact our business, including our clinical trials, supply chain operation, regulatory timelines and commercial activities. |
• | We have a limited operating history and we may incur significant losses in the future, which makes it difficult to assess our future viability. |
• | We may require substantial additional financing to achieve our goals, and a failure to obtain this necessary capital when needed on acceptable terms, or at all, could force us to delay, limit, scale back or cease our commercialization activities, product development or any other or all operations. |
• | We are substantially dependent on the success of TransCon hGH and our other product candidates, which may not be successful in nonclinical studies or clinical trials, receive regulatory approval or be successfully commercialized. |
• | Clinical drug development involves a lengthy and expensive process with uncertain outcomes, and we may encounter substantial delays in our clinical studies. Furthermore, results of earlier studies and trials may not be predictive of results of future trials. |
• | Interim, “top-line” and preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data. |
• | Our sales and marketing efforts for TransCon hGH may not be effective and we may not be successful in our commercial efforts. |
• | Competition in the biotechnology and pharmaceutical industries is intense and our competitors may discover, develop or commercialize products faster or more successfully than us. If we are unable to compete effectively our business, results of operations and prospects will suffer. |
• | We rely on third-parties to manufacture our preclinical and clinical drug supplies, and we rely on third-parties to produce commercial supplies of TransCon hGH and its device components. |
• | Our operating results may vary significantly from period to period and these variations may be difficult to predict. |
• | The parent drug, drug substance, drug product and other components of TransCon hGH and our other product candidates are currently acquired from certain single-source suppliers. The loss of these suppliers, or their failure to supply could materially and adversely affect our business. |
• | The regulatory approval processes of the U.S. Food and Drug Administration, the European Medicines Agency and comparable authorities are lengthy, time consuming, and inherently unpredictable. If we are ultimately unable to obtain regulatory approval for our product candidates, our business will be substantially harmed. |
• | If we are sued for allegedly infringing intellectual property rights of third parties, it will be costly and time consuming, and an unfavorable outcome in such litigation could harm 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 |
• | completing research and preclinical and clinical development of our product candidates; |
• | on our own, or together with our strategic collaboration partners, obtaining additional regulatory approvals for our products and product candidates; |
• | negotiating favorable terms of and entering into collaboration, licensing or other arrangements; |
• | our ability to commercialize or co-promote, and/or the ability of our collaboration partners to successfully commercialize, our products and product candidates; |
• | developing and sustaining a scalable manufacturing process for TransCon hGH and for any of our other product candidates, if approved, and establishing and maintaining supply and manufacturing relationships with third-parties that can conduct the process and provide adequate, in amount and quality, products to support clinical development and the market demand for TransCon hGH and for our other product candidates, if approved; |
• | obtaining market acceptance of TransCon hGH, and of our other product candidates, if approved, as viable treatment options; |
• | addressing any competing technological and market developments; |
• | identifying, assessing, acquiring, in-licensing and/or developing new product candidates; |
• | maintaining, protecting, and expanding our portfolio of intellectual property rights, including patents, trade secrets, and know-how, and our ability to develop, manufacture and commercialize our product candidates and products without infringing intellectual property rights of others; and |
• | attracting, hiring, and retaining qualified personnel. |
• | the manufacturing, selling and marketing costs associated with TransCon hGH and with our other product candidates, if approved, including the cost and timing of building our sales and marketing capabilities; |
• | the timing, receipt, and amount of sales of, or royalties on, TransCon hGH and any future products; |
• | the sales price and the availability of adequate third-party coverage and reimbursement for TransCon hGH and for our other product candidates, if approved; |
• | our ability to establish and maintain strategic partnerships, licensing or other arrangements and the financial terms of such agreements; |
• | our ability to collect payments which are due to us from collaboration partners (if any), which in turn is impacted by the financial standing of any such collaboration partners; |
• | the progress, timing, scope, results and costs of our preclinical studies and clinical trials and manufacturing activities for our product candidates, including the ability to enroll patients in a timely manner for clinical trials; |
• | the time and cost necessary to obtain regulatory approvals for our product candidates and the costs of post-marketing studies that could be required by regulatory authorities; |
• | the cash requirements of any future acquisitions or discovery of product candidates; |
• | the number and scope of preclinical and discovery programs that we decide to pursue or initiate; |
• | the potential acquisition and in-licensing of other technologies, products or assets; |
• | the time and cost necessary to respond to technological and market developments, including further development of our TransCon technologies; |
• | the achievement of development, regulatory and commercial milestones resulting in the payment to us from collaboration partners of contractual milestone payments and the timing of receipt of such payments, if any; |
• | our progress in the successful commercialization and co-promotion of TransCon hGH and of our other product candidates, if approved, and our efforts to develop and commercialize our other existing product candidates; and |
• | the costs of filing, prosecuting, maintaining, defending and enforcing any patent claims and other intellectual property rights, including litigation costs and the outcome of such litigation, including costs of defending any claims of infringement brought by others in connection with the development, manufacture or commercialization of our product candidates. |
• | the outcome and successful execution of our ongoing and planned clinical trials of TransCon hGH and our other product candidates; |
• | our ability and that of any collaboration partners to establish and maintain commercial-scale manufacturing processes for our products, product candidates and device components; |
• | whether our product candidates’ safety, purity, potency, tolerability and/or efficacy profiles will be satisfactory to the European Medicines Agency (“EMA”), the FDA and similar regulatory authorities to warrant marketing approval; |
• | whether the EMA, the FDA or similar regulatory authorities will require additional clinical trials prior to approving our product candidates, if ever; |
• | the prevalence and severity of adverse side effects of TransCon hGH and our other product candidates; |
• | the occurrence of adverse events that implicate the TransCon technologies, including among any out-licensed product candidates; |
• | the timely receipt of necessary marketing authorizations or certifications for our product candidates and associated device components from the FDA, similar regulatory authorities and notified bodies; |
• | our ability and that of any collaboration partners to successfully commercialize TransCon hGH or to commercialize our other product candidates, if approved for marketing and sale by the FDA or similar regulatory authorities, including educating physicians and patients about the benefits, administration and use of such products; |
• | achieving and maintaining compliance with all applicable regulatory requirements; |
• | acceptance of TransCon hGH, or our other product candidates, if approved, as safe and effective by patients and the medical community; |
• | acceptance of the device components of our combination products and combination product candidates, if approved, including the TransCon hGH auto-injector and the TransCon PTH drug delivery device and associated Bluetooth connectivity features, by patients and the medical community; |
• | the availability, perceived advantages, relative cost, relative safety and relative efficacy of alternative and competing treatments; |
• | obtaining and sustaining an adequate level of coverage and reimbursement for TransCon hGH and our other product candidates by third-party payors; |
• | the effectiveness of our and any collaboration partners’ marketing, sales and distribution strategies and operations; |
• | our ability and that of any collaboration partners, or any third-party manufacturer we contract with, to manufacture supplies of TransCon hGH and/or our other product candidates and to develop, validate and maintain commercially viable manufacturing processes that are compliant with current good manufacturing practice, or cGMP, or similar requirements; |
• | enforcing intellectual property rights in and to TransCon hGH and our other product candidates; |
• | avoiding third-party interference, opposition, derivation or similar proceedings with respect to our patent rights, and avoiding other challenges to our patent rights and patent infringement claims; and |
• | continued acceptable safety profiles of TransCon hGH and of our other product candidates following any potential approval. |
• | generate sufficient preclinical, toxicology, or other in vivo or in vitro data to support the initiation or continuation of clinical trials; |
• | reach consensus with regulatory authorities on study design or implementation of the clinical trials and/or obtain regulatory authorization to commence a trial; |
• | reach agreement on acceptable terms with prospective contract research organizations (“CROs”) and clinical trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites; |
• | identify, recruit and train suitable clinical investigators; |
• | obtain institutional review board (“IRB”) or ethics committee approval at each site; |
• | manufacture, test, release, validate or import sufficient quantities of drug product for use in a trial; |
• | recruit, screen and enroll suitable patients to participate in a trial; |
• | have patients complete a trial or return for post-treatment follow-up; |
• | ensure that clinical sites observe trial protocol or continue to participate in a trial; |
• | address any patient safety concerns that arise during the course of a trial; |
• | address any conflicts with new or existing laws or regulations; or |
• | initiate or add a sufficient number of clinical trial sites. |
• | the research methodology used and our TransCon technologies may not be successful in creating potential product candidates; |
• | competitors may develop alternatives that render our product candidates obsolete or less attractive; |
• | product candidates we develop may nevertheless be covered by third-parties’ intellectual property rights or other types of exclusivity and we may not be able to obtain a license from such third-party or the license terms may not be acceptable to us; |
• | the market for a product candidate may change during our program or we may discover that such market was smaller than initially expected so that such a product may become financially unfeasible to continue to develop; |
• | a product candidate may be demonstrated to have harmful side effects or not to be effective, or otherwise not to meet other requirements for regulatory approval; |
• | a product candidate may not be capable of being produced in commercial quantities at an acceptable cost, or at all; and |
• | a product candidate may not be accepted as safe and effective by patients, the medical community or third-party payors, or reimbursable by third-party payors, if applicable. |
• | the safety, purity, potency and/or efficacy of the products as demonstrated in clinical trials; |
• | the prevalence and severity of any side effects and overall safety profile of the product; |
• | the perceived safety of the TransCon technologies; |
• | the convenience and features of the auto-injector or drug delivery device used to administer the drug; |
• | the clinical indications for which the product is approved; |
• | acceptance by physicians, major operators of clinics and patients of the product as a safe and effective treatment and their willingness to pay for them; |
• | relative convenience and ease of administration of our products; |
• | the potential and perceived advantages of our product candidates over current treatment options or alternative treatments, including future alternative treatments; |
• | the availability of supply of our products and their ability to meet market demand; |
• | marketing and distribution support for our product candidates; |
• | the quality of our relationships with patient advocacy groups; and |
• | coverage and reimbursement policies of government and other third-party payors. |
• | regulatory authorities may withdraw their approval of the product or seize the product; |
• | we, or any collaboration partners, may be required to recall the product; |
• | additional restrictions may be imposed on the marketing of the particular product or the manufacturing processes for the product or any component thereof, including the imposition of a REMS or requirements for similar actions, such as patient education, certification of health care professionals or specific monitoring; |
• | we, or any collaboration partners, may be subject to fines, injunctions or the imposition of civil or criminal penalties; |
• | regulatory authorities may require additional warnings on the label, including “boxed” warnings, or issue safety alerts, Dear Healthcare Provider letters, press releases or other communications containing warnings or other safety information about the product; |
• | we could be sued and held liable for harm caused to patients; |
• | the product may become less competitive; and |
• | our reputation may suffer. |
• | filing new formulation patent applications on drugs whose original patent protection is about to expire; |
• | filing an increasing number of patent applications that are more complex and costly to challenge; |
• | filing suits for alleged patent infringement that automatically delay FDA or foreign regulatory authorities approval; |
• | developing patented controlled-release or other “next-generation” products, which may compete with TransCon product candidates; |
• | establishing exclusive contracts with third-party payors; or |
• | changing product claims and product labeling. |
• | significantly greater name recognition, financial, marketing, research, drug development and technical and human resources than we have at every stage of the discovery, development, manufacturing and commercialization process and additional mergers and acquisitions in the biotechnology industries may result in even more resources being concentrated in our competitors; |
• | more extensive experience in commercializing drugs, conducting preclinical testing, conducting clinical studies, obtaining regulatory approvals, challenging patents and in manufacturing and marketing pharmaceutical products; |
• | products that have been approved or are in late stages of development; and |
• | collaboration arrangements in our target markets with leading companies and research institutions. |
• | the safety and effectiveness of such product candidates; |
• | the timing of and specific circumstances relating to regulatory approvals for these product candidates; |
• | the availability and cost of manufacturing, marketing and sales capabilities; |
• | the effectiveness of our marketing and sales capabilities; |
• | the price of our product candidates; |
• | the availability and amount of third-party reimbursement for our product candidates; and |
• | the strength of our patent position. |
• | our ability to hire and retain required sales and marketing personnel; |
• | our ability to provide sufficient training to develop and strengthen the technical expertise of our sales and marketing personnel; |
• | our ability to provide required support materials and resources to our sales personnel to help them educate physicians and healthcare providers regarding TransCon hGH and its proper administration; and |
• | our resources to meet and timely fulfill supply obligations to our customers. |
• | our collaboration partners have the unilateral ability to choose not to develop a collaboration product for one or more indications for which such product has been or is currently being evaluated, and our collaboration partners may choose to pursue an indication that is not in our strategic best interest or to forego an indication that they believe does not provide significant market potential even if clinical data is supportive of further development for such indication; |
• | our collaboration partners may choose not to develop and commercialize our collaboration products in certain relevant markets; |
• | our collaboration partners may take considerably more time advancing our product candidates through the clinical and regulatory process than we currently anticipate, which could materially delay the achievement of milestones and, consequently the receipt of milestone payments from our collaboration partners; |
• | our collaboration partners have substantial discretion under their respective agreements regarding how they structure their efforts and allocate resources to fulfill their obligations to diligently develop, obtain regulatory approval for and commercialize our collaboration products; |
• | our collaboration partners control all aspects of commercialization efforts under their respective license agreements and may change the focus of their development and commercialization efforts or pursue higher-priority programs and, accordingly, reduce the efforts and resources allocated to their collaborations with us; |
• | our collaboration partners are solely responsible for obtaining and maintaining all regulatory approvals and we or our collaboration partners may fail to develop a commercially viable formulation or manufacturing process for our product candidates, and we or our collaboration partners may fail to manufacture or supply sufficient drug substance for commercial use, if approved, which could result in lost revenue under such collaborations; |
• | our collaboration partners may not comply with all applicable regulatory requirements or may fail to report safety data in accordance with all applicable regulatory requirements; |
• | if any of our agreements with our collaboration partners terminate, we will no longer have any rights to receive potential revenue under such agreement, in which case we would need to identify alternative means to continue the development, manufacture and commercialization of the affected product candidates, alone or with others; |
• | our collaboration partners have the discretion to sublicense their rights with respect to our collaboration technology in connection with collaboration product candidates to one or more third-parties without our consent; and |
• | our collaboration partners may be pursuing alternative technologies or developing alternative products, either on their own or in collaboration with others, that may be competitive with products on which they are collaborating with us or which could affect our collaboration partners’ commitment to the collaboration. |
• | production yields; |
• | quality control and assurance; |
• | shortages of qualified personnel; |
• | compliance with FDA and foreign regulations; |
• | production costs; and |
• | development of advanced manufacturing techniques and process controls. |
• | decreased demand for TransCon hGH and our other product candidates; |
• | injury to our reputation; |
• | withdrawal of clinical trial participants; |
• | costs to defend the related litigation; |
• | a diversion of management’s time and our resources; |
• | substantial monetary awards to trial participants or patients; |
• | regulatory investigations, product recalls or withdrawals, or labeling, marketing or promotional restrictions; |
• | loss of revenue; and |
• | the inability to commercialize or co-promote TransCon hGH or our other product candidates. |
• | expand our general and administrative functions; |
• | identify, recruit, retain, incentivize and integrate additional employees; |
• | manage our internal development efforts effectively while carrying out our contractual obligations to third-parties; |
• | establish and build a marketing and commercial organization; and |
• | continue to improve our operational, legal, financial and management controls, reporting systems and procedures. |
• | the timing of regulatory approvals, if any, for our product candidates; |
• | the amount and timing of revenue from product sales; |
• | the initiation of intellectual property litigation by third-parties or by us; |
• | the amount and timing of operating costs and capital expenditures relating to the expansion of our business operations and facilities; |
• | the timing of the commencement, completion or termination of collaboration agreements; |
• | the timing and amount of payments to us under collaboration agreements, if any; |
• | the introduction of new products and services by us, collaboration partners or our competitors; |
• | delays in preclinical testing and clinical studies; |
• | changes in regulatory requirements for clinical studies; |
• | costs and expenses associated with preclinical testing and clinical studies; and |
• | payment of license fees for the right to use third-party proprietary rights, if any. |
• | up-front, milestone and royalty payments, equity investments and financial support of new research and development candidates including increase of personnel, all of which may be substantial; |
• | exposure to unknown liabilities, including potential indemnification claims from a potential spin-off or out-license of certain of our intellectual property rights; |
• | disruption of our business and diversion of our management’s time and attention to develop acquired products, product candidates or technologies; |
• | incurrence of substantial debt or dilutive issuances of equity securities to pay for acquisitions; |
• | higher-than-expected acquisition and integration costs; |
• | lower-than-expected benefits, from out-licensing or selling our technology, intellectual property or any of our subsidiaries or, from in-licensing intellectual property or purchasing assets; |
• | write-downs of assets or goodwill or impairment charges; |
• | difficulty and cost in combining or separating the operations and personnel of any acquired or sold businesses with our existing operations and personnel; |
• | impairment of relationships with key suppliers or customers of any acquired or sold businesses due to changes in our senior management and ownership; and |
• | inability to retain key employees of any acquired businesses. |
• | different regulatory requirements for drug approvals in foreign countries; |
• | differing drug import and export rules; |
• | reduced protection for intellectual property rights in foreign countries; |
• | unexpected changes in tariffs, trade barriers and regulatory requirements; |
• | different reimbursement systems, and different competitive drugs; |
• | economic weakness, including inflation, or political instability in particular foreign economies and markets; |
• | compliance with tax, employment, immigration and labor laws for employees living or traveling abroad; |
• | foreign taxes, including withholding of payroll taxes; |
• | foreign currency fluctuations, which could result in increased operating expenses and reduced revenues, and other obligations incident to doing business in another country; |
• | workforce uncertainty in countries where labor unrest is more common than in the United States; |
• | production shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad; |
• | potential liability resulting from work conducted by these distributors; |
• | regulatory and compliance risks that relate to maintaining accurate information and control over sales and activities that may fall within the purview of the Foreign Corrupt Practices Act, its books and records provisions, or its anti-bribery provisions; and |
• | business interruptions resulting from geopolitical actions, including war and terrorism, or natural disasters. |
• | the research methodology used may not be successful in identifying potential product candidates; or |
• | potential product candidates may, on further study, be shown to have inadequate efficacy, harmful side effects or other characteristics suggesting that they are unlikely to be effective or safe products, or that they may not be sufficiently differentiated or offer substantial improvement over the currently available treatment options or standard of care in a given therapeutic category. |
• | delays or difficulties in enrolling and retaining patients in our clinical trials, which could potentially have a negative impact on clinical trial timelines; |
• | delays or difficulties in clinical site initiation, including difficulties in recruiting clinical site investigators and clinical site staff; |
• | significant increases in expenses required to manage impacts to our business to complete our planned operations within our projected timelines; |
• | diversion of healthcare resources away from the conduct of clinical trials, including the diversion of hospitals serving as our clinical trial sites and hospital staff supporting the conduct of our clinical trials; |
• | interruption of key clinical trial activities, such as clinical trial site monitoring, due to limitations on travel imposed or recommended by federal or state governments, employers and others; |
• | limitations in employee resources that would otherwise be focused on the conduct of our clinical trials and commercialization activities, including because of sickness of employees or their families or the desire of employees to avoid contact with large groups of people; |
• | delays in receiving approval from local regulatory authorities to initiate our planned clinical trials; |
• | delays in clinical sites receiving the supplies and materials needed to conduct our clinical trials; |
• | interruption in global storage and shipping that may affect the supply of TransCon hGH or the transport of clinical trial materials, such as comparator drugs used in certain of our clinical trials; |
• | interruptions in our global supply chain with regards to clinical trials and commercial supply; |
• | changes in local regulations as part of a response to the COVID-19 outbreak which may require us to change the ways in which our clinical trials are conducted, which may result in unexpected costs, or to discontinue the clinical trials altogether; |
• | delays in necessary interactions with local regulators, ethics committees and other important agencies and contractors due to limitations in employee resources or forced furlough of government employees; |
• | refusal of regulatory authorities to accept data from clinical trials in these affected geographies; |
• | in conducting our clinical trials, suppliers may experience delays in providing necessary equipment, consumables and services, which could cause temporary delays in clinical trial activities; |
• | global demand for COVID-19 vaccines or COVID-19 therapeutics could result in contract manufacturers not having sufficient capacity to meet scheduled manufacturing. In addition, sourcing of certain types of raw materials, consumables and equipment could result in scheduled manufacturing being delayed or postponed; |
• | travel restrictions and local outbreaks of COVID-19 could restrict authorities from performing site inspections in connection with their review procedures of marketing applications for TransCon hGH, which could potentially delay the commercial launch in areas outside of the United States; and |
• | our commercial launch strategy, including for TransCon hGH, could be negatively impacted by patients not being able to see their physicians, and similarly, our commercial team not being able to meet in-person with physicians and payors, which could both have a negative impact on the commercial launch strategy. |
• | warning letters; |
• | civil and criminal penalties; |
• | injunctions; |
• | withdrawal of regulatory approval of products; |
• | product seizure or detention; |
• | product recalls; |
• | total or partial suspension of production; and |
• | refusal to approve pending NDAs or BLAs, MAA, or supplements to approved NDAs or BLAs or extensions or variations to marketing authorizations. |
• | the EMA, the FDA or other comparable foreign regulatory authorities may disagree with the design or implementation of our, or any collaboration partners’, clinical studies; |
• | the population studied in the clinical program may not be sufficiently broad or representative to assure safety in the full population for which approval is sought; |
• | the EMA, the FDA or comparable foreign regulatory authorities may disagree with the interpretation of data from preclinical studies or clinical studies; |
• | the data collected from clinical studies of our product candidates may not be sufficient to support the submission of an NDA or BLA, MAA, or other submission or to obtain regulatory approval in the United States, the EU or elsewhere; |
• | we, or any collaboration partners, may be unable to demonstrate to the EMA, the FDA or comparable foreign regulatory authorities that a product candidate’s risk-benefit ratio for its proposed indication is acceptable; |
• | the FDA or comparable foreign regulatory authorities may fail to approve the manufacturing processes, test procedures and specifications, or facilities of third-party manufacturers responsible for clinical and commercial supplies; and |
• | the approval policies or regulations of the FDA or comparable foreign regulatory authorities may significantly change in a manner rendering our clinical data insufficient for approval. |
• | warning letters, fines or holds on clinical trials; |
• | restrictions on the marketing or manufacturing of the product, withdrawal of the product from the market or voluntary or mandatory product recalls; |
• | injunctions or the imposition of civil or criminal penalties; |
• | suspension or revocation of existing regulatory approvals; |
• | suspension of any of our future or ongoing clinical trials; |
• | refusal to approve pending applications or supplements to approved applications submitted by us; |
• | restrictions on our or our contract manufacturers’ operations; or |
• | product seizure or detention, or refusal to permit the import or export of products. |
• | the U.S. Anti-Kickback Statute, which prohibits, among other things, persons and entities from knowingly and willfully soliciting, receiving, offering or paying remuneration, directly or indirectly, in exchange for or to induce either the referral of an individual for, or the purchase, order or recommendation of, any good or service for which payment may be made under U.S. federal healthcare programs such as the Medicare and Medicaid programs. A person or entity does not need to have actual knowledge of the statute or specific intent to violate it to have committed a violation; |
• | U.S. false claims laws which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, claims for payment from Medicare, Medicaid, or other third-party payors that are false or fraudulent. In addition, the government may assert that a claim including items or services resulting from a violation of the U.S. federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the False Claims Act; |
• | U.S. federal criminal laws that prohibit executing a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters; |
• | the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), which imposes criminal and civil liability for, among other things, knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program, or knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false statement, in connection with the delivery of, or payment for, healthcare benefits, items or services; similar to the U.S. federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation; |
• | the U.S. federal Physician Payments Sunshine Act, which requires certain manufacturers of drugs, devices, biologics, and medical supplies to report annually to the CMS information related to payments and other transfers of value to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors), certain non-physician practitioners (physician assistants, nurse practitioners, clinical nurse specialists, certified nurse anesthetists, anesthesiologist assistants and certified nurse midwives) and teaching hospitals, and ownership and investment interests held by physicians (as defined under statute) and their immediate family members; |
• | state law equivalents of each of the above U.S. federal laws, such as anti-kickback and false claims laws which may apply to items or services reimbursed by any third-party payor, including commercial insurers; |
• | state laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the applicable compliance guidance promulgated by the U.S. federal government, or otherwise restrict payments that may be made to healthcare providers and other potential referral sources; |
• | state laws that require drug manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures and pricing information; and |
• | additional clinical trials to be conducted prior to obtaining approval; |
• | changes to manufacturing methods; |
• | recall, replacement, or discontinuance of one or more of our products; and |
• | additional record keeping. |
• | protect our trade secrets; |
• | apply for, obtain, maintain and enforce patents; and |
• | operate without infringing upon the proprietary rights of others. |
• | we might not have been the first to invent or the first to file the inventions covered by each of our pending patent applications and issued patents; |
• | others may independently develop similar or alternative technologies or duplicate any of our technologies; |
• | the patents of others may have an adverse effect on our business; |
• | any patents we obtain or our in-licensed issued patents may not encompass commercially viable products, may not provide us with any competitive advantages or may be challenged by third-parties; |
• | any patents we obtain or our in-licensed issued patents may not be valid or enforceable; or |
• | we may not develop additional proprietary technologies that are patentable. |
• | protect and enforce our patents and any future patents issuing on our patent applications; |
• | enforce or clarify the terms of the licenses we have granted or may be granted in the future; |
• | protect and enforce trade secrets, know-how and other proprietary rights that we own or have licensed, or may license in the future; or |
• | determine the enforceability, scope and validity of the proprietary rights of third-parties and defend against alleged patent infringement. |
• | our ability to commercialize or obtain regulatory approval for TransCon hGH or our other product candidates, or delays in commercializing or obtaining regulatory approval; |
• | results from, or any delays in, clinical trial programs relating to TransCon hGH or our other product candidates; |
• | the effects on our business, operating results, prospects and financial condition of the worldwide COVID-19 pandemic; |
• | our ability to apply our TransCon technologies to therapeutic areas other than endocrinology, including the therapeutic area of oncology; |
• | announcements of regulatory approval or a complete response letter to our product candidates, or specific label indications or patient populations for use, or changes or delays in the regulatory review process; |
• | announcements relating to current or future collaborations or joint ventures; |
• | announcements of therapeutic innovations or new products by us or our competitors; |
• | announcements regarding the parent drugs that we use in developing our product candidates; |
• | adverse actions taken by regulatory authorities with respect to our clinical trials, manufacturing supply chain or sales and marketing activities; |
• | changes or developments in laws or regulations applicable to TransCon hGH or our other product candidates; |
• | any adverse changes to our relationship with any manufacturers or suppliers; |
• | the success of our testing and clinical trials; |
• | the success of our efforts to acquire, license or discover additional products or product candidates; |
• | any intellectual property infringement actions in which we may become involved; |
• | announcements concerning our competitors or the pharmaceutical industry in general; |
• | achievement of expected product sales and profitability; |
• | manufacture, supply or distribution shortages; |
• | actual or anticipated fluctuations in our operating results; |
• | EMA, FDA or other similar regulatory actions affecting us or our industry or other healthcare reform measures in the European Union, United States or in other markets; |
• | changes in the structure of healthcare payment systems; |
• | changes in financial estimates or recommendations by securities analysts; |
• | trading volume of the ADSs; |
• | sales or purchases of ordinary shares and/or ADSs by us, our senior management and board members, holders of the ADSs or our shareholders in the future; |
• | general economic and market conditions and overall fluctuations in the United States and international equity markets, including deteriorating market conditions due to investor concerns regarding inflation and hostilities between Russia and Ukraine; and |
• | the loss of any of our key scientific or senior management personnel. |
Item 4 |
Information on the Company |
A. |
History and Development of the Company |
B. |
Business Overview |
• | First Marketed Product ® (lonapegsomatropin-tcgd), developed as TransCon Growth Hormone (“TransCon hGH”), which has received regulatory approval in the United States for the treatment of pediatric patients one year and older who weigh at least 11.5 kg and have growth failure due to inadequate secretion of endogenous growth hormone, also known as growth hormone deficiency (“GHD”) and which is now commercially available for prescription in the United States. TransCon hGH is also approved under the name Lonapegsomatropin Ascendis Pharma for the treatment of children and adolescents aged from 3 years up to 18 years due to insufficient endogenous growth hormone secretion in the European Union (“EU”). |
• | Endocrinology Rare Disease Pipeline |
• | Oncology IL-2 ß/g for systemic delivery, which is designed for prolonged exposure to an IL-2 variant that selectively activates the IL-2Rß/ g , with minimal binding to IL-2Rα. Our clinical development program for these product candidates also includes evaluation of them as a potential combination therapy. |
1. |
Developed under the name TransCon hGH and approved under the name Lonapegsomatropin Ascendis Pharma |
2. |
In development in Greater China through strategic investment in VISEN Pharmaceuticals (“VISEN”) |
3. |
Japanese riGHt Trial |
4. |
Global foresiGHt Trial |
5. |
North American and European PaTHway Trial |
6. |
Japanese PaTHway Japan Trial |
7. |
North America, Europe, and Oceania ACcomplisH Trial |
8. |
transcendIT-101 Trial |
9. |
IL-ßelie g e Trial |
• | Obtain regulatory approval for three independent Endocrinology Rare Disease products |
• | TransCon hGH for pediatric growth hormone deficiency** |
• | TransCon PTH for adult hypoparathyroidism |
• | TransCon CNP for achondroplasia |
• | Grow Endocrinology Rare Disease pipeline through: |
• | Global clinical reach |
• | Pursuing 9 total indications, label optimization, and life cycle management |
• | New endocrinology products |
• | Establish global commercial presence for our Endocrinology Rare Disease area: |
• | Build integrated commercial organization in North America and select European countries |
• | Establish global commercial presence through partners with local expertise and infrastructure |
• | Advance a high-value oncology pipeline with one investigational new drug (“IND”) or similar submission each year |
• | Create a third independent therapeutic area with a diversified pipeline |
• | Systemic |
• | Localized |
• | Unmodified somatropin (hGH): Two long-acting growth hormone products using encapsulation technologies have previously received regulatory approval in U.S. and Europe and were subsequently discontinued due to commercial challenges. These include Nutropin Depot ® , formerly marketed by Genentech, and Somatropin Biopartners, developed by LG Life Sciences and Biopartners GmbH. Nutropin Depot was approved in 1999 and later withdrawn; Somatropin Biopartners (LB03002), was approved by the European Medicines Agency (“EMA”), in 2013, and later withdrawn. We believe that the lack of market acceptance is a result of the various safety and tolerability issues that tend to arise with encapsulation technologies. |
• | Permanent modification of growth hormone: Modification technologies prolong activity in the body by creating analogs of growth hormone through permanent modification of the growth hormone molecule. This modification may alter the molecular size and interaction with the growth hormone receptor and/or change the natural association affinity to endogenous proteins, as well as the distribution in the body. These changes may alter and reduce the efficacy of these drugs compared to unmodified daily somatropin (hGH) and may also negatively impact the drug’s safety. |
• | A national study has shown 66%, or 2/3 of patients miss more than one injection per week. We believe reducing injection frequency is associated with better adherence and thus may improve height velocity. |
• | In a Phase 3 clinical study, TransCon hGH demonstrated higher AHV compared to daily somatropin with similar safety profile in treatment-naïve children with GHD. |
• | With a weekly injection, patients switching from daily injections can experience up to 86% fewer injection days per year. |
• | After first removed from a refrigerator, SKYTROFA (lonapegsomatropin-tcgd) can be stored at room temperature for up to six months. |
• | No incidence of treatment emergent anti-hGH neutralizing antibodies detected, and post-baseline low level of low-titer non-neutralizing anti-hGH binding antibodies was similar between the two arms (6 [5.7%] in TransCon hGH vs. 2 [3.6%] in Genotropin arm). |
• | Height SDS at 52 weeks increased over baseline by 1.10 for TransCon hGH and by 0.96 for the daily hGH, with the treatment difference increasing at each visit over 52 weeks. |
• | Body Mass Index (BMI) was in the normal range over 52 weeks in both the TransCon hGH group (with a mean increase in BMI SDS from -0.32 at baseline to -0.03 at week 52) and in the daily hGH group (with a mean BMI SDS decrease from -0.14 at baseline to -0.40 at week 52). |
• | Mean hemoglobin A1c values were generally stable over the course of the trial and remained within the normal range for both arms. |
• | Model-derived mean average insulin-like growth factor-1 (“IGF-1”) SDS values were 0.72 for TransCon hGH and -0.02 for the daily hGH at week 52. |
• | Adverse events leading to dose reduction (IGF-1 levels or clinical symptoms) occurred twice in the TransCon hGH arm (representing 1.9%) and once in the daily hGH arm (representing 1.8%). |
• | Observed change in bone age over 52 weeks from baseline was 1.36 years for the TransCon hGH arm and 1.35 years in the daily arm. |
• | Sales Force: In the United States, growth hormone is prescribed by approximately 8,000 health care providers with the top 1,400 prescribers consisting of pediatric endocrinologists, endocrinologists, pediatricians, nurse practitioners, and physician assistants, accounting for approximately 80% of the prescription volume. Our United States sales organization is focused on these high-volume prescribers. |
• | Medical Affairs: Our Medical Affairs organization is educating stakeholders and broadening SKYTROFA (lonapegsomatropin-tcgd) awareness. |
• | Market Access: Payor coverage and reimbursement are important factors which can influence market adoption. Recognizing this importance, our Market Access organization has been engaging national and regional payors in an effort to garner reimbursement for SKYTROFA (lonapegsomatropin-tcgd). |
• | Mean serum calcium levels remained stable and in the normal range. |
• | All study subjects discontinued active vitamin D supplements in the earliest weeks of the trial and have remained off it since then. In addition, 93% of subjects were taking calcium supplements < 600 mg per day. |
• | Mean urinary calcium excretion remained stable and in the normal range. |
• | TransCon PTH was well-tolerated at all doses administered. No treatment-related serious or severe adverse events occurred, and no treatment-emergent adverse events (“TEAEs”) led to discontinuation of study drug. |
• | Injections were well-tolerated using pen injector planned for commercial presentation. |
• | All mean summary and subdomain SF-36 Health Survey scores continued normalization between week 26 and week 58 despite all mean scores starting below norms at baseline. |
• | Bone mineral density Z-scores trended towards normalization and stabilization over 58 weeks in PaTH Forward. |
|
1 |
CNP measured as CNP-38. |
• | TransCon TLR7/8 Agonist is an investigational long-acting prodrug, designed for sustained release of resiquimod, a small molecule agonist of Toll-like receptors (“TLR”) 7 and 8. It is designed to provide sustained and potent activation of the innate immune system in the tumor and tumor draining lymph node and to have a low risk of systemic toxicity for weeks or months following a single intratumoral injection. Enrollment continues in the Phase 1/2 transcendIT-101 Trial for which we submitted an IND in 2020, with top-line data expected from monotherapy and checkpoint combination dose escalation in the third quarter of 2022. |
• | TransCon IL-2 b /g is an investigational long-acting prodrug designed to improve cancer immunotherapy through sustained release of an IL-2 variant that selectively activates the IL-2R b /g , with minimal binding to IL-2Rα. The Phase 1/2 IL- b elieg e Trial evaluating TransCon IL-2 b /g monotherapy in patients with advanced cancer is enrolling. We also aim to dose the first patient in checkpoint combination dose-escalation arm of the IL- b elieg e Trial in the second quarter of 2022, and we expect top-line monotherapy data in the fourth quarter of 2022. |
• | We believe that a combination TransCon TLR7/8 Agonist and TransCon IL-2 b /g may have the potential to produce greater anti-tumor activity than either candidate alone. During the fourth quarter of 2022, the Company plans to submit an IND or similar for Phase 2 cohort expansion for combination therapy with TransCon TLR7/8 Agonist and TransCon IL-2 b /g . |
• | completion of preclinical laboratory tests, animal studies and formulation studies in compliance with the FDA’s Good Laboratory Practice regulations; |
• | submission to the FDA of an IND which must become effective before human clinical trials may begin; |
• | approval by an independent institutional review board, or IRB, at each clinical site before each trial may be initiated; |
• | performance of adequate and well-controlled human clinical trials in accordance with good clinical practice, or GCP, requirements to establish the safety and efficacy of the proposed drug or biological product for each indication; |
• | submission to the FDA of an NDA or BLA after completion of all pivotal clinical trials; |
• | satisfactory completion of an FDA advisory committee review, if applicable; |
• | satisfactory completion of an FDA inspection of the manufacturing facility or facilities at which the product is produced to assess compliance with current good manufacturing practice, or cGMP, requirements and to assure that the facilities, methods and controls are adequate to preserve the drug’s or biologic’s identity, strength, quality and purity and of selected clinical investigation sites to assess compliance with GCP; and |
• | FDA review and approval of the NDA or BLA to permit commercial marketing of the product for particular indications for use in the United States. |
• | Phase 1: The product candidate is initially introduced into healthy human subjects or patients with the target disease or condition and tested for safety, optimal dosage, absorption, metabolism, distribution, excretion and, if possible, to gain an early indication of its effectiveness. |
• | Phase 2: The product candidate is administered to a limited patient population to identify possible adverse effects and safety risks, to preliminarily evaluate the efficacy of the product for specific diseases and to determine optimal dosage. |
• | Phase 3: The product candidate is administered to an expanded patient population, generally at geographically dispersed clinical trial sites, typically in well-controlled trials, to generate enough data to statistically evaluate the efficacy and safety of the product for approval, to establish the overall risk-benefit profile of the product, and to provide adequate information for the labeling of the product. |
• | restrictions on the marketing or manufacturing of the product, complete withdrawal of the product from the market or product recalls; |
• | fines, warning letters or holds on post-approval clinical trials; |
• | refusal of the FDA to approve pending NDAs or BLAs or supplements to approved NDAs or BLAs, or suspension or revocation of product license approvals; |
• | product seizure or detention, or refusal to permit the import or export of products; or |
• | injunctions or the imposition of civil or criminal penalties. |
• | “Centralized MAs” are issued by the European Commission through the centralized procedure based on the opinion of the Committee for Medicinal Products for Human Use, or CHMP, of the European Medicines Agency, or EMA, and are valid throughout the EU. The centralized procedure is compulsory for certain types of medicinal products such as (i) medicinal products derived from biotechnological processes, (ii) designated orphan medicinal products, (iii) advanced therapy medicinal products, or ATMPs (such as gene therapy, somatic cell therapy and tissue engineered products) and (iv) medicinal products containing a new active substance indicated for the treatment of certain diseases, such as HIV/AIDS, cancer, diabetes, neurodegenerative diseases or autoimmune diseases and other immune dysfunctions, and viral diseases. The centralized procedure is optional for products containing a new active substance not authorized in the EU before May 20, 2004, or that represent a significant therapeutic, scientific or technical innovation, or whose authorization would be in the interest of public health in the EU. |
• | “National MAs” are issued by the competent authorities of the EU member states, only cover their respective territory, and are available for product candidates not falling within the mandatory scope of the centralized procedure. Where a product has already been authorized for marketing in an EU member state, this national MA can be recognized in |
another member state through the mutual recognition procedure. If the product has not received a national MA in any member state at the time of application, it can be approved simultaneously in various member states through the decentralized procedure. Under the decentralized procedure an identical dossier is submitted to the competent authorities of each of the member states in which the MA is sought, one of which is selected by the applicant as the reference member state. |
C. |
Organizational Structure |
D. |
Property, Plant and Equipment |
Location |
Size (in square meters) |
Primary usage |
Enforceable lease period |
Option to extend the lease beyond enforceable lease period | ||||||||
Denmark |
||||||||||||
Tuborg Boulevard, Hellerup |
7,775 | Corporate headquarter, administration and R&D | July, 2029 | No | ||||||||
Tuborg Boulevard, Hellerup |
4,128 | Administration | May, 2038 | No | ||||||||
Germany |
||||||||||||
Technologiepark, Heidelberg |
2,134 | R&D and laboratory facilities | January, 2025 | Rolling 24 months option to extend | ||||||||
Technologiepark, Heidelberg |
480 | R&D and laboratory facilities | December, 2024 | No | ||||||||
Technologiepark, Heidelberg |
538 | R&D and laboratory facilities | October, 2024 | No | ||||||||
Grundbuch von Heidelberg Blatt, Heidelberg (1) |
2,321 | Administration, R&D and laboratory facilities | January, 2026 | No | ||||||||
Kurfürstendamm, Berlin |
165 | Clinical operations | May, 2022 | No | ||||||||
United States |
||||||||||||
Emerson Street, Palo Alto, California |
1,134 | Administration and clinical operations | April, 2022 | No | ||||||||
Redwood City, California |
3,681 | R&D and laboratory facilities | April, 2030 | Option to extend for additional five years | ||||||||
Page Mill, Palo Alto, California (2) |
6,765 | Administration | October, 2033 | Option to extend for up to two periods of five years each | ||||||||
West Windsor Township, New Jersey |
1,097 | Selling and administration | December, 2025 | Option to extend for additional five years |
(1) | Our lease in Grundbuch von Heidelberg Blatt was entered in 2021 and commenced in January 2022. |
(2) | Our Page Mill lease commenced in November 2020. After entering the lease, the facilities have undergone significant leasehold improvements. The Page Mill location has been in operation since October 1, 2021. |
Item 4A |
Unresolved Staff Comments |
Item 5 |
Operating and Financial Review and Prospects |
A. |
Operating Results |
• | Encouraging employees to work remotely, reduce travel activity and minimize face-to-face |
• | Establishing home offices, and ensuring proper and secure IT infrastructure to improve the safety and efficiency of the remote work environment; |
• | Implementing remote visits for patients enrolled in our clinical trials, including ensuring safe delivery of clinical drugs; and |
• | Addressing COVID-19 in relation to logistics and manufacturing at Joint Steering Committees with manufacturing partners. |
• | In conducting our clinical trials, there is a risk that suppliers experience delays in providing necessary equipment, consumables and services, which could cause temporary delays in clinical trial activities. In addition, there is a risk that patients will elect not to enroll in trials to limit their exposure to medical institutions, which could have a negative impact on clinical trial enrollment and timelines; |
• | Global demand for COVID-19 vaccines and treatments could result in contract manufacturers not having sufficient capacity to meet scheduled manufacturing. In addition, sourcing of certain types of raw materials, consumables and equipment could result in scheduled manufacturing being delayed or postponed. We are monitoring the global supply chain and as of the date of this report, we have not experienced material delays due to potential effected supply; and |
• | Our commercial launch strategy could be negatively impacted by (i) patients not being able to see their physicians, and (ii) our commercial team not being able to meet with physicians. |
Year Ended December 31, |
||||||||||||
2021 |
2020 |
2019 |
||||||||||
(EUR’000) |
||||||||||||
Revenue |
7,778 | 6,953 | 13,375 | |||||||||
Cost of sales |
3,523 | — | — | |||||||||
|
|
|
|
|
|
|||||||
Gross profit |
4,255 |
6,953 |
13,375 |
|||||||||
|
|
|
|
|
|
|||||||
Research and development costs |
295,867 | 260,904 | 191,621 | |||||||||
Selling, general and administrative expenses |
160,180 | 76,669 | 48,473 | |||||||||
|
|
|
|
|
|
|||||||
Operating profit/(loss) |
(451,792 |
) |
(330,620 |
) |
(226,719 |
) | ||||||
|
|
|
|
|
|
|||||||
Share of profit/(loss) in associate |
12,041 | (9,524 | ) | (8,113 | ) | |||||||
Finance income |
59,718 | 1,812 | 17,803 | |||||||||
Finance expenses |
3,911 | 80,842 | 1,221 | |||||||||
|
|
|
|
|
|
|||||||
Profit/(loss) before tax |
(383,944 |
) |
(419,174 |
) |
(218,250 |
) | ||||||
|
|
|
|
|
|
|||||||
Tax on profit/(loss) for the year |
367 | 219 | 234 | |||||||||
|
|
|
|
|
|
|||||||
Net profit/(loss) for the year |
(383,577 |
) |
(418,955 |
) |
(218,016 |
) | ||||||
|
|
|
|
|
|
Year Ended December 31, |
||||||||||||
2021 |
2020 |
2019 |
||||||||||
(EUR’000) |
||||||||||||
Sale of commercial products |
943 | — | — | |||||||||
Rendering of services |
751 | 2,140 | 9,919 | |||||||||
Sale of clinical supply |
3,719 | 2,206 | 804 | |||||||||
“Right-to-use” |
2,365 | 2,607 | 2,652 | |||||||||
|
|
|
|
|
|
|||||||
Total revenue |
7,778 |
6,953 |
13,375 |
|||||||||
|
|
|
|
|
|
• | Determining whether the promises in the agreements are distinct performance obligations; |
• | Identifying and constraining variable consideration in the transaction price including milestone payments; |
• | Allocating transaction price to identified performance obligations based on their relative stand-alone selling prices; and |
• | Determining whether performance obligations are satisfied over time, or at a point in time. |
December 31, 2021 |
December 31, 2020 |
|||||||||||||||
Carrying amount |
Fair value |
Carrying amount |
Fair value |
|||||||||||||
(EUR’000) |
||||||||||||||||
Marketable securities specified by investment grade credit rating |
||||||||||||||||
Prime |
— | — | 7,716 | 7,714 | ||||||||||||
High grade |
144,307 | 144,030 | 142,339 | 142,352 | ||||||||||||
Upper medium grade |
196,909 | 196,566 | 99,503 | 99,464 | ||||||||||||
Lower medium grade |
2,142 | 2,135 | — | — | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total marketable securities |
343,358 |
342,731 |
249,558 |
249,530 |
||||||||||||
|
|
|
|
|
|
|
|
B. |
Liquidity and Capital Resources |
Carrying amount |
Fair value |
|||||||
(EUR’000) |
||||||||
December 31, 2021 |
||||||||
Liquidity and capital resources |
||||||||
Marketable securities |
343,358 | 342,731 | ||||||
Cash and cash equivalents |
446,267 | 446,267 | ||||||
|
|
|
|
|||||
Total liquidity and capital resources |
789,625 |
788,998 |
||||||
|
|
|
|
|||||
Classification in consolidated statement of financial position |
||||||||
Non-current assets |
107,561 | 107,175 | ||||||
Current assets |
682,064 | 681,823 | ||||||
|
|
|
|
|||||
Total liquidity and capital resources |
789,625 |
788,998 |
||||||
|
|
|
|
• | In 2016, with net proceeds of $127.1 million (or €116.6 million); |
• | In 2017, with net proceeds of $145.2 million (or €123.1 million); |
• | In 2018, with net proceeds of $242.5 million (or €198.6 million); |
• | In 2019, with net proceeds of $539.4 million (or €480.3 million); |
• | In 2020, with net proceeds of $654.6 million (or €580.5 million); and |
• | In 2021, with net proceeds of $436.3 million (or €367.9 million). |
• | lease obligations, related to our office and research and development facilities, which are recognized as lease liabilities in the consolidated statement of financial position; |
• | construction of property, plant and equipment, including leasehold improvements; |
• | purchase obligations, under our commercial supply agreements and related activities; |
• | research and development activities related to clinical trials for our product candidates in clinical development. |
• | the manufacturing, selling and marketing costs associated with TransCon hGH and with our other product candidates, if approved, including the cost and timing of building our sales and marketing capabilities; |
• | the timing, receipt, and amount of sales of, or royalties on, TransCon hGH and any future products; |
• | the sales price and the availability of adequate third-party coverage and reimbursement for TransCon hGH and for our other product candidates, if approved; |
• | our ability to establish and maintain strategic partnerships, licensing or other arrangements and the financial terms of such agreements; |
• | our ability to collect payments which are due to us from collaboration partners (if any), which in turn is impacted by the financial standing of any such collaboration partners; |
• | the progress, timing, scope, results and costs of our preclinical studies and clinical trials and manufacturing activities for our product candidates that have not been licensed, including the ability to enroll patients in a timely manner for clinical trials; |
• | the time and cost necessary to obtain regulatory approvals for our product candidates and the costs of post-marketing studies that could be required by regulatory authorities; |
• | the cash requirements of any future acquisitions or discovery of product candidates; |
• | the number and scope of preclinical and discovery programs that we decide to pursue or initiate; |
• | the potential acquisition and in-licensing of other technologies, products or assets; |
• | the time and cost necessary to respond to technological and market developments, including further development of our TransCon technologies; |
• | the achievement of development, regulatory and commercial milestones resulting in the payment to us from collaboration partners of contractual milestone payments and the timing of receipt of such payments, if any; |
• | our progress in the successful commercialization and co-promotion of TransCon hGH and of our other product candidates, if approved, and our efforts to develop and commercialize our other existing product candidates; and |
• | the costs of filing, prosecuting, maintaining, defending and enforcing any patent claims and other intellectual property rights, including litigation costs and the outcome of such litigation, including costs of defending any claims of infringement brought by others in connection with the development, manufacture or commercialization of our product candidates. |
Year Ended December 31, |
||||||||||||
2021 |
2020 |
2019 |
||||||||||
(EUR’000) |
||||||||||||
Cash flows from/(used in) operating activities |
(417,649 | ) | (271,548 | ) | (175,936 | ) | ||||||
Cash flows from/(used in) investing activities |
(110,579 | ) | (291,199 | ) | (5,159 | ) | ||||||
Cash flows from/(used in) financing activities |
351,387 | 602,650 | 493,593 | |||||||||
|
|
|
|
|
|
|||||||
Net increase in cash and cash equivalents |
(176,841 |
) |
39,903 |
312,498 |
||||||||
|
|
|
|
|
|
C. |
Research and Developments, Patents and Licenses, etc. |
D. |
Trend Information |
E. |
Off-Balance Sheet Arrangements |
Item 6 |
Directors, Senior Management and Employees |
A. |
Directors and Senior Management |
Name of Board Member |
Age |
Position(s) |
Term Expires | |||
Albert Cha, M.D., Ph.D. |
49 | Chairman and Board Member |
2022 | |||
Lisa Bright |
54 | Board Member |
2023 | |||
James I. Healy, M.D., Ph.D. |
56 | Board Member |
2023 | |||
Lars Holtug |
63 | Board Member |
2022 | |||
Jan Møller Mikkelsen |
62 | President, Chief Executive Officer and Board Member |
2023 | |||
Rafaèle Tordjman, M.D., Ph.D. |
52 | Board Member |
2022 |
Name |
Age |
Position(s) | ||
Jan Møller Mikkelsen | 62 | President, Chief Executive Officer and Board Member | ||
Vibeke Miller Breinholt, Ph.D. | 55 | Senior Vice President, Nonclinical Development and Bioanalysis | ||
Jesper Høiland | 61 | Senior Vice President, Global Chief Commercial Officer | ||
Flemming Steen Jensen | 60 | Senior Vice President, Product Supply and Quality | ||
Michael Wolff Jensen, L.L.M. | 50 | Senior Vice President, Chief Legal Officer | ||
Sigurd Okkels, Ph.D. | 61 | Senior Vice President, Product Development | ||
Dana Pizzuti, M.D. | 66 | Senior Vice President, Development Operations and Chief Medical Officer | ||
Juha Punnonen, M.D., Ph.D. | 56 | Senior Vice President, Head of Oncology | ||
Peter Rasmussen | 53 | Vice President, Finance and Principal Accounting Officer | ||
Stina Singel, M.D., Ph.D. | 48 | Senior Vice President, Head of Clinical Development, Oncology | ||
Scott T. Smith | 48 | Senior Vice President, Chief Financial Officer | ||
Lotte Sønderbjerg | 60 | Senior Vice President, Chief Administrative Officer | ||
Kennett Sprogøe, Ph.D. | 43 | Senior Vice President, Head of Innovation and Research | ||
Birgitte Volck, M.D., Ph.D. | 59 | Senior Vice President, Head of Clinical Development and Medical Affairs |
Board Diversity Matrix (As of March 1, 2022) | ||||||||
Country of Principal Executive Offices |
Denmark | |||||||
Foreign Private Issuer |
Yes | |||||||
Disclosure Prohibited under Home Country Law |
No | |||||||
Total Number of Directors |
6 | |||||||
Female |
Male |
Non- Binary |
Did Not Disclose Gender | |||||
Part I: Gender Identity |
||||||||
Directors |
2 | 3 | 0 | 1 | ||||
Part II: Demographic Background | ||||||||
Underrepresented Individual in Home Country |
0 | |||||||
LGBTQ+ |
0 | |||||||
Did Not Disclose Demographic Background |
1 |
B. |
Compensation |
Name |
Grant Date |
Shares Subject to Awards Granted |
Award Exercise Price(s) |
Award Expiration Date | ||||||||||||
Birgitte Volck |
July 13, 2021 | 60,000 | $124.52 | (€105.1334) | July 13, 2031 | |||||||||||
Birgitte Volck |
December 9, 2021 | 7,252 | $139.65 | (€123,4637) | December 9, 2031 | |||||||||||
Vibeke Miller Breinholt |
December 9, 2021 | 14,504 | $139.65 | (€123,4637) | December 9, 2031 | |||||||||||
Dana Pizzuti |
December 9, 2021 | 14,504 | $139.65 | (€123.4637) | December 9, 2031 | |||||||||||
Jesper Høiland |
December 9, 2021 | 14,504 | $139.65 | (€123.4637) | December 9, 2031 | |||||||||||
Sigurd Okkels |
December 9, 2021 | 14,504 | $139.65 | (€123.4637) | December 9, 2031 | |||||||||||
Juha Punnonen |
December 9, 2021 | 14,504 | $139.65 | (€123.4637) | December 9, 2031 | |||||||||||
Jan Møller Mikkelsen |
December 9, 2021 | 69,466 | $139.65 | (€123.4637) | December 9, 2031 | |||||||||||
Scott T. Smith |
December 9, 2021 | 14,504 | $139.65 | (€123.4637) | December 9, 2031 | |||||||||||
Michael Wolff Jensen |
December 9, 2021 | 14,504 | $139.65 | (€123.4637) | December 9, 2031 | |||||||||||
Lotte Sønderbjerg |
December 9, 2021 | 14,504 | $139.65 | (€123,4637) | December 9, 2031 | |||||||||||
Flemming Steen Jensen |
December 9, 2021 | 14,504 | $139.65 | (€123,4637) | December 9, 2031 | |||||||||||
Kennett Sprogøe |
December 9, 2021 | 14,504 | $139.65 | (€123.4637) | December 9, 2031 | |||||||||||
Peter Rasmussen |
December 9, 2021 | 3,053 | $139.65 | (€123.4637) | December 9, 2031 |
Name |
Grant Date |
Awards granted and outstanding |
Awards granted and outstanding, but unvested as of March 1, 2022 |
Award Exercise Price(s) |
Award Expiration Date | |||||||||||||
Jan Møller Mikkelsen |
December 3, 2012 | 279,372 | — | € | 7.9962 | 21 days following our interim report (six-month report) in 2023 | ||||||||||||
November 26, 2014 | 31,624 | — | € | 6.4775 | 21 days following our interim report (nine-month report) in 2023 | |||||||||||||
December 18, 2015 | 217,000 | — | € | 15.6750 | December 18, 2025 | |||||||||||||
December 14, 2016 | 180,000 | — | € | 19.4194 | December 14, 2026 | |||||||||||||
December 12, 2017 | 200,000 | — | € | 31.5995 | December 12, 2027 | |||||||||||||
December 11, 2018 | 200,000 | 41,667 | € | 54.6357 | December 11, 2028 | |||||||||||||
December 10, 2019 | 120,000 | 55,000 | € | 97.4993 | December 10, 2029 | |||||||||||||
December 10, 2020 | 101,145 | 71,645 | € | 145.5045 | December 10, 2030 | |||||||||||||
December 9, 2021 | 69,466 | 69,466 | € | 123,4637 | December 9, 2031 | |||||||||||||
James I. Healy, M.D., Ph.D. |
December 18, 2015 | 35,000 | — | € | 15.6750 | December 18, 2025 | ||||||||||||
December 14, 2016 | 15,000 | — | € | 19.4194 | December 14, 2026 | |||||||||||||
December 12, 2017 | 15,000 | — | € | 31.5995 | December 12, 2027 | |||||||||||||
December 11, 2018 | 13,000 | — | € | 54.6357 | December 11, 2028 | |||||||||||||
December 10, 2019 | 7,500 | — | € | 97.4993 | December 10, 2029 | |||||||||||||
December 10, 2020 | 6,420 | 2,675 | € | 145.5045 | December 10, 2030 | |||||||||||||
December 9, 2021 | 3,053 | 3,053 | € | 123,4637 | December 9, 2031 |
C. |
Board Practices |
• | making recommendations to our board of directors regarding the appointment by the general meeting of shareholders of our independent auditors; |
• | overseeing the work of the independent auditors, including making recommendations to the board of directors and resolving disagreements between the executive board and the independent auditors relating to financial reporting; |
• | reviewing the independence and quality control procedures of the independent auditors; |
• | discussing material off-balance sheet transactions, arrangements and obligations with the executive board and the independent auditors; |
• | reviewing all proposed related-party transactions; |
• | discussing the annual audited consolidated and statutory financial statements with the executive board; |
• | annually reviewing and reassessing the adequacy of our audit committee charter; |
• | meeting separately with the independent auditors to discuss critical accounting policies, recommendations on internal controls, the auditor’s engagement letter and independence letter and other material written communications between the independent auditors and the executive board; and |
• | attending to such other matters as are specifically delegated to our audit committee by our board of directors from time to time. |
• | reviewing and making recommendations to our board of directors with respect to compensation of our executive board and members of our board of directors; |
• | reviewing and approving the compensation, including equity compensation, change-of-control |
• | overseeing and making recommendations to our board of directors regarding the evaluation of our executive board; |
• | reviewing periodically and making recommendations to our board of directors with respect to any incentive compensation and equity plans, programs or similar arrangements; and |
• | attending to such other matters as are specifically delegated to our compensation committee by our board of directors from time to time. |
• | recommending to our board of directors, persons to be nominated for election or re-election to our board of directors at any meeting of the shareholders; |
• | overseeing our board of director’s annual review of its own performance and the performance of its committees; and |
• | considering, preparing and recommending to our board of directors a set of corporate governance guidelines. |
D. |
Employees |
Selling, General and Administration (1) |
Research and Development, and commercial manufacturing |
Total |
||||||||||
December 31, 2021 |
||||||||||||
Denmark (Domicile country) |
74 | 205 | 279 | |||||||||
Germany |
25 | 80 | 105 | |||||||||
United States |
137 | 118 | 255 | |||||||||
|
|
|
|
|
|
|||||||
Total |
236 |
403 |
639 |
Selling, General and Administration (1) |
Research and Development |
Total |
||||||||||
December 31, 2020 |
||||||||||||
Denmark (Domicile country) |
50 | 167 | 217 | |||||||||
Germany |
— | 96 | 96 | |||||||||
United States |
63 | 106 | 169 | |||||||||
|
|
|
|
|
|
|||||||
Total |
113 |
369 |
482 |
Selling, General and Administration (1) |
Research and Development |
Total |
||||||||||
December 31, 2019 |
||||||||||||
Denmark (Domicile country) |
35 | 121 | 156 | |||||||||
Germany |
— | 73 | 73 | |||||||||
United States |
33 | 68 | 101 | |||||||||
|
|
|
|
|
|
|||||||
Total |
68 |
262 |
330 |
(1) | Selling, General and Administration function includes business and corporate development, and pre-commercial activities. |
E. |
Share Ownership |
Item 7 |
Major Shareholders and Related Party Transactions |
A. |
Major Shareholders |
• | each person, or group of affiliated persons, known by us to beneficially own more than 5% of our outstanding ordinary shares; |
• | each of our board members; and |
• | each member of our senior management, including members of our executive board. |
Name and Address of Beneficial Owner |
Number of Outstanding Shares Beneficially Owned |
Number of Warrants Exercisable and RSUs to be Settled Within 60 Days |
Number of Shares Beneficially Owned |
Percentage of Beneficial Ownership |
||||||||||||
Entities affiliated with Artisan Partners LP(1) |
7,940,434 | — | 7,940,434 | 13.9 | % | |||||||||||
Entities affiliated with RA Capital Management, L.P.(2) |
7,567,900 | — | 7,567,900 | 13.3 | % | |||||||||||
Entities affiliated with FMR LLC(3) |
5,355,943 | — | 5,355,943 | 9.4 | % | |||||||||||
T. Rowe Price Associates, Inc.(4) |
4,761,193 | — | 4,761,193 | 8.4 | % | |||||||||||
Baker Bros. Advisors LP(5) |
4,541,604 | — | 4,541,604 | 8.0 | % | |||||||||||
Entities affiliated with Wellington Management Group LLP(6) |
4,068,476 | — | 4,068,476 | 7.2 | % | |||||||||||
Entities affiliated with Janus Henderson Group plc(7) |
3,219,965 | — | 3,219,965 | 5.7 | % | |||||||||||
Senior Management and Board Members |
||||||||||||||||
Jan Møller Mikkelsen(8) |
507,096 | 1,169,603 | 1,676,699 | 2.8 | % | |||||||||||
Vibeke Miller Breinholt, Ph.D.(9) |
— | 42,443 | 42,443 | * | ||||||||||||
Jesper Høiland(10) |
— | 44,115 | 44,115 | * | ||||||||||||
Flemming Steen Jensen(11) |
— | 110,359 | 110,359 | * | ||||||||||||
Michael Wolff Jensen, L.L.M.(12) |
— | 98,859 | 98,859 | * | ||||||||||||
Sigurd Okkels, Ph.D.(13) |
— | 69,322 | 69,322 | * | ||||||||||||
Dana Pizzuti, M.D.(14) |
— | 27,509 | 27,509 | * |
Name and Address of Beneficial Owner |
Number of Outstanding Shares Beneficially Owned |
Number of Warrants Exercisable and RSUs to be Settled Within 60 Days |
Number of Shares Beneficially Owned |
Percentage of Beneficial Ownership |
||||||||||||
Juha Punnonen, M.D., Ph.D.(15) |
— | 80,631 | 80,631 | * | ||||||||||||
Peter Rasmussen(16) |
— | 50,481 | 50,481 | * | ||||||||||||
Stina Singel, M.D, Ph.D.(17) |
— | 24,679 | 24,679 | * | ||||||||||||
Scott T. Smith(18) |
1,000 | 148,859 | 149,859 | * | ||||||||||||
Lotte Sønderbjerg(19) |
— | 151,895 | 151,895 | * | ||||||||||||
Kennett Sprogøe, Ph.D.(20) |
30 | 129,172 | 129,202 | * | ||||||||||||
Birgitte Volck, M.D., Ph.D.(21) |
230 | 62,412 | 62,642 | * | ||||||||||||
Albert Cha, M.D., Ph.D.(22) |
— | 89,512 | 89,512 | * | ||||||||||||
Lisa Bright(23) |
— | 44,617 | 44,617 | * | ||||||||||||
James I. Healy, M.D., Ph.D.(24) |
1,480,800 | 89,512 | 1,570,312 | 2.8 | % | |||||||||||
Lars Holtug, M.Sc.(25) |
— | 40,678 | 40,678 | * | ||||||||||||
Rafaèle Tordjman, M.D., Ph.D.(26) |
— | 12,812 | 12,812 | * |
* | Indicates beneficial ownership of less than 1% of the total outstanding ordinary shares. |
(1) | Consists of an aggregate of 7,940,434 ADSs beneficially owned, or that may be deemed to be beneficially owned, by Artisan Partners Limited Partnership (“APLP”), Artisan Investments GP LLC (“Artisan Investments”), Artisan Partners Holdings LP (“Artisan Holdings”), Artisan Partners Asset Management Inc. (“APAM”), and Artisan Partners Funds, Inc. (“Artisan Funds”) as reported by Amendment No. 2 to Schedule 13G filed on February 4, 2022. Artisan Holdings is the sole limited partner of APLP and the sole member of Artisan Investments; Artisan Investments is the general partner of APLP; APAM is the general partner of Artisan Holdings. APLP, Artisan Investments, Artisan Holdings and APAM have shared voting power over 6,830,520 shares and shared dispositive power over 7,940,434 shares. Artisan Funds has shared voting and dispositive power over 3,453,421 shares. The address of APLP, Artisan Investments, Artisan Holdings, APAM, and Artisan Funds is 875 East Wisconsin Avenue, Suite 800, Milwaukee, WI 53202. |
(2) | Consists of 7,567,900 ADSs held by RA Capital Healthcare Fund, L.P. (the “RA Fund”) as reported by Amendment No. 11 to Schedule 13G filed with the SEC on February 14, 2022 by RA Capital Management, L.P. (“RA Capital”). RA Capital Healthcare Fund GP, LLC is the general partner of the RA Fund. The general partner of RA Capital is RA Capital Management GP, LLC, of which Peter Kolchinsky and Rajeev Shah are the controlling persons. RA Capital serves as investment adviser for the RA Fund and may be deemed a beneficial owner of ADSs held by the RA Fund. The RA Fund has delegated to RA Capital the sole power to vote and the sole power to dispose of all securities held in the RA Fund’s portfolio. Because the RA Fund has divested voting and investment power over the reported securities it holds and may not revoke that delegation on less than 61 days’ notice, the RA Fund disclaims beneficial ownership of the securities it holds and therefore disclaims any obligation to report ownership of the reported securities. As managers of RA Capital, Dr. Kolchinsky and Mr. Shah may be deemed beneficial owners of the ADSs beneficially owned by RA Capital. The address of the RA Fund, the RA Capital, Dr. Kolchinsky and Mr. Shah is c/o RA Capital Management, L.P., 200 Berkeley Street, 18th Floor, Boston, MA 02116. |
(3) | Consists of an aggregate of 5,355,943 ADSs beneficially owned, or that may be deemed to be beneficially owned, by FMR LLC, certain of its affiliates and other companies as reported on Amendment No. 8 to Schedule 13G filed on February 9, 2022 by FMR LLC. Abigail P. Johnson is a Director, the Chairman and the Chief Executive Officer of FMR LLC. Members of the Johnson family, including Abigail P. Johnson, are the predominant owners, directly or through trusts, of Series B voting common shares of FMR LLC, representing 49% of the voting power of FMR LLC. The Johnson family group and all other Series B shareholders have entered into a shareholders’ voting agreement under which all Series B voting common shares will be voted in accordance with the majority vote of Series B voting common shares. Accordingly, through their ownership of voting common shares and the execution of the shareholders’ voting agreement, members of the Johnson family may be deemed, under the Investment Company Act of 1940, to form a controlling group with respect to FMR LLC. Neither FMR LLC nor Abigail P. Johnson has the sole power to vote or direct the voting of the shares owned directly by the various investment companies registered under the Investment Company Act (“Fidelity Funds”) advised by Fidelity Management & Research Company LLC (“FMR Co”), a wholly owned subsidiary of FMR LLC, which power resides with the Fidelity Funds’ Boards of Trustees. FMR Co carries out the voting of the shares under written guidelines established by the Fidelity Funds’ Boards of Trustees. FMR LLC has its principal business office at 245 Summer Street, Boston, MA 02210. |
(4) | Consists of 4,761,193 ordinary shares and ADSs held by T. Rowe Price Associates, Inc. (“Price Associates”) as reported by Amendment No. 4 to Schedule 13G filed on February 14, 2022 by Price Associates. Price Associates, may be deemed to have sole power to vote over 1,596,799 shares and sole power to dispose of 4,761,193 shares. The address of Price Associates is 100 E. Pratt Street, Baltimore, Maryland 21202. |
(5) | Consists of (i) 4,195,958 ADSs held by Baker Brothers Life Sciences, L.P. (“Life Sciences”) and (ii) 345,646 ADSs held by 667, L.P. (“667” and together with Life Sciences, the “Funds”) as reported on Amendment No. 4 to Schedule 13G filed on February 14, 2022 by Baker Bros. Advisors LP (the “Adviser”), Baker Bros. Advisors (GP) LLC (the “Adviser GP”), Felix J. Baker and Julian C. Baker (collectively, “Baker Bros.”). The Adviser GP, Felix J. Baker and Julian C. Baker as managing members of the Adviser GP, and the Adviser may be deemed to be beneficial owners of the ADSs directly held by the Funds. The Adviser GP is the sole general partner of the Adviser. Pursuant to the management agreements, as amended, among the Adviser, Life Sciences and 667 and their respective general partners, the Funds’ respective general partners relinquished to the Adviser all discretion and authority with respect to the investment and voting power of the securities held by the Funds, and thus the Adviser has complete and unlimited discretion and authority with respect to the Funds’ investments and voting power over investments. The address of Baker Bros. is c/o Baker Bros. Advisors LP, 860 Washington Street, 3 rd Floor, New York, NY 10014. |
(6) | Consists of an aggregate of 4,068,476 ADSs beneficially owned, or that may be deemed to be beneficially owned, by Wellington Management Group LLP (“Management Group”), certain of its affiliates and other companies as reported by Amendment No. 1 to Schedule 13G filed on February 4, 2022 by Management Group, Wellington Group Holdings LLP, Wellington Investment Advisors Holdings LLP and Wellington Management Global Holdings, Ltd. The address of the Management Group is 280 Congress Street, Boston, MA 02210. |
(7) | Consists of an aggregate of 3,219,965 ADSs beneficially owned, or that may be deemed to be beneficially owned, by Janus Henderson Group plc (“Janus Henderson”) as reported on Amendment No. 1 to Schedule 13G filed on February 10, 2022. The address of Janus Henderson is 201 Bishopsgate, EC2M 3AE, United Kingdom. |
(8) | Consists of (i) 507,096 ordinary shares and ADSs held by Mr. Mikkelsen, and (ii) 1,169,603 ordinary shares that may be subscribed pursuant to the exercise of warrants within 60 days of February 1, 2022 by Mr. Mikkelsen. |
(9) | Consists of 42,443 ordinary shares that may be subscribed pursuant to the exercise of warrants within 60 days of February 1, 2022 by Dr. Breinholt. |
(10) | Consists of 44,115 ordinary shares that may be subscribed pursuant to the exercise of warrants within 60 days of February 1, 2022 by Mr. Høiland. |
(11) | Consists of 110,359 ordinary shares that may be subscribed pursuant to the exercise of warrants within 60 days of February 1, 2022 by Mr. Jensen. |
(12) | Consists of 98,859 ordinary shares that may be subscribed pursuant to the exercise of warrants within 60 days of February 1, 2022 by Mr. Jensen. |
(13) | Consists of 69,322 ordinary shares that may be subscribed pursuant to the exercise of warrants within 60 days of February 1, 2022 by Dr. Okkels. |
(14) | Consists of 27,509 ordinary shares that may be subscribed pursuant to the exercise of warrants within 60 days of February 1, 2022 by Dr. Pizzuti. |
(15) | Consists of 80,631 ordinary shares that may be subscribed pursuant to the exercise of warrants within 60 days of February 1, 2022 by Dr. Punnonen. |
(16) | Consists of 50,481 ordinary shares that may be subscribed pursuant to the exercise of warrants within 60 days of February 1, 2022 by Mr. Rasmussen |
(17) | Consists of 24,679 ordinary shares that may be subscribed pursuant to the exercise of warrants within 60 days of February 1, 2022 by Dr. Singel. |
(18) | Consists of (i) 1,000 ordinary shares held by Mr. Smith and (ii) 148,859 ordinary shares that may be subscribed pursuant to the exercise of warrants within 60 days of February 1, 2022 by Mr. Smith. |
(19) | Consists of 151,895 ordinary shares that may be subscribed pursuant to the exercise of warrants within 60 days of February 1, 2022 by Ms. Sønderbjerg. |
(20) | Consists of (i) 129,172 ordinary shares that may be subscribed pursuant to the exercise of warrants within 60 days of February 1, 2022 by Dr. Sprogøe and (ii) 30 ADSs held by family members of Dr. Sprogøe. |
(21) | Consists of (i) 62,412 ordinary shares that may be subscribed pursuant to the exercise of warrants within 60 days of February 1, 2022 by Dr. Volck and (ii) 230 ADSs held by family members of Dr. Volck. |
(22) | Consists of 89,512 ordinary shares that may be subscribed pursuant to the exercise of warrants within 60 days of February 1, 2022 by Dr. Cha. |
(23) | Consists of 44,617 ordinary shares that may be subscribed pursuant to the exercise of warrants within 60 days of February 1, 2022 by Ms. Bright. |
(24) | Consists of (i) 89,512 ordinary shares that may be subscribed pursuant to the exercise of warrants within 60 days of February 1, 2022 by Dr. Healy, (ii) 1,480,800 ordinary shares and ADSs held by Sofinnova Venture Partners IX, L.P. (“SVP IX”). Sofinnova Management IX, L.L.C. (“SM IX”) is the general partner of SVP IX and may be deemed to have sole power to vote and sole power to dispose of shares directly owned by SVP IX. Dr. James I. Healy is the sole managing member of SM IX and may be deemed to have voting and dispositive power over the shares directly owned by each of SVP IX and SM IX. Dr. Healy disclaims beneficial ownership over the shares held by SVP IX and SM IX, except to the extent of his pecuniary interests therein. The address of SVP IX is c/o Sofinnova Ventures, Inc., 3000 Sand Hill Road, Bldg. 4, Suite 250, Menlo Park, California 94025. |
(25) | Consists of 40,678 ordinary shares that may be subscribed pursuant to the exercise of warrants within 60 days of February 1, 2022 by Mr. Holtug. |
(26) | Consists of 12,812 ordinary shares that may be subscribed pursuant to the exercise of warrants within 60 days of February 1, 2022 by Dr. Tordjman. |
B. |
Related Party Transactions |
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 |
A. |
Offer and Listing Details |
B. |
Plan of Distribution |
C. |
Markets |
D. |
Selling Shareholders |
E. |
Dilution |
F. |
Expenses of the Issue |
Item 10 |
Additional Information |
A. |
Share Capital |
B. |
Memorandum and Articles of Association |
• | Our board of directors is authorized to increase our share capital by up to 9,000,000 shares with pre-emptive subscription rights for existing shareholders in connection with cash contributions, provided, however, that the capital increases are carried out at market value. This authorization is valid until May 28, 2024. |
• | Our board of directors is authorized at one or more times to increase our share capital by up to nominal DKK 6,125,000 without pre-emptive subscription rights for existing shareholders. Capital increases according to this authorization can be carried out by our board of directors by way of contributions in kind, conversion of debt and/or cash contributions, and must be carried out at market price. This authorization is valid until May 27, 2026. |
• | Our board of directors is authorized to issue 597,037 warrants and to increase our share capital by up to 597,037 shares without pre-emptive subscription rights for existing shareholders in connection with the exercise, if any, of said warrants and to determine the terms and conditions thereof. This authorization is valid until May 28, 2025. |
• | Our board of directors is, without pre-emptive rights for the existing shareholders, authorized to obtain loans against issuance of convertible notes which confer the right to subscribe up to 9,000,000 shares. The convertible notes shall be offered at a subscription price and a conversion price that correspond in aggregate to at least the market price of the shares at the time of the decision of our board of directors to issue the convertible notes. The loans shall be paid in cash and our board of directors shall determine the terms and conditions for the convertible notes. This authorization is valid until May 28, 2024. |
• | Our board of directors is on one or more occasions authorized to issue 719,551 warrants to members of the executive management and employees, advisors and consultants of the company or our subsidiaries and to increase our share capital by up to 719,551 shares, without pre-emptive subscription rights for existing shareholders in connection with the exercise, if any, of said warrants and to determine the terms and conditions thereof. The exercise price for the warrants shall at least be equal to the market price of the shares at the time of issuance. This authorization is valid until May 27, 2026. |
• | the convening notice, |
• | the documents that shall be presented at the general meeting, which will in case of the annual general meeting include the annual report, and |
• | the agenda and the complete proposals. |
• | The material facts as to the director’s relationship or interest are disclosed and a majority of disinterested directors’ consent; |
• | The material facts are disclosed as to the director’s relationship or interest and a majority of shares entitled to vote thereon consent; or |
• | The transaction is fair to the corporation at the time it is authorized by the board of directors, a committee of the board of directors or the stockholders. |
• | the transaction that will cause the person to become an interested stockholder is approved by the board of directors of the target prior to the transaction; |
• | after the completion of the transaction in which the person becomes an interested stockholder, the interested stockholder holds at least 85% of the voting stock of the corporation not including shares owned by persons who are directors and officers of interested stockholders and shares owned by specified employee benefit plans; or |
• | after the person becomes an interested stockholder, the business combination is approved by the board of directors of the corporation and holders of at least 66.67% of the outstanding voting stock, excluding shares held by the interested stockholder. |
C. |
Material Contracts |
D. |
Exchange Controls |
E. |
Taxation |
• | U.S. expatriates and certain former citizens or long-term residents of the United States; |
• | persons whose functional currency is not the U.S. dollar; |
• | persons holding the ADSs as part of a hedge, straddle or other risk reduction strategy or as part of a conversion transaction or other integrated investment; |
• | banks, insurance companies, and other financial institutions; |
• | real estate investment trusts or regulated investment companies; |
• | brokers, dealers or traders in securities, commodities or currencies; |
• | partnerships, S corporations or other entities or arrangements treated as partnerships or pass-through entities for U.S. federal income tax purposes; |
• | tax-exempt organizations or governmental organizations; |
• | persons who acquired the ADSs pursuant to the exercise of any employee share option or otherwise as compensation; |
• | persons that own or are deemed to own 10% or more of the company’s equity by vote or value; |
• | persons that hold their ADSs through a permanent establishment or fixed base outside the United States; and |
• | persons deemed to sell the ADSs under the constructive sale provisions of the Code. |
• | an individual who is a citizen or resident of the United States; |
• | a corporation, or other entity taxable as a corporation, created or organized under the laws of the United States, any state thereof, or the District of Columbia; |
• | an estate, the income of which is subject to U.S. federal income tax regardless of its source; or |
• | a trust that (1) is subject to the supervision of a U.S. court and the control of one or more “United States persons” (within the meaning of Section 7701(a)(30) of the Code), or (2) has a valid election in effect under applicable Treasury Regulations to be treated as a United States person for U.S. federal income tax purposes. |
• | at least 75% of its gross income for such taxable year is passive income, or |
• | at least 50% of the value of its assets (generally based on an average of the quarterly values of the assets) during such taxable year) is attributable to assets that produce or are held for the production of passive income. |
• | the “excess distribution” or gain will be allocated ratably over your holding period for the ADSs, |
• | the amount allocated to the current taxable year, and any taxable year before the first taxable year in your holding period in which we were a PFIC, will be treated as ordinary income, and |
• | the amount allocated to each other year will be subject to the highest income tax rate in effect for that year and the interest charge generally applicable to underpayments of tax will be imposed on the resulting tax attributable to each such year. |
• | fails to furnish the holder’s taxpayer identification number, which for an individual is ordinarily his or her social security number; |
• | furnishes an incorrect taxpayer identification number; |
• | is notified by the IRS that the holder previously failed to properly report payments of interest or dividends; or |
• | fails to certify under penalties of perjury that the holder has furnished a correct taxpayer identification number and that the IRS has not notified the holder that the holder is subject to backup withholding. |
F. |
Dividends and Paying Agents |
G. |
Statements 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. |
Persons depositing or withdrawing ordinary shares or ADSs must pay: |
For: | |
$5.00 (or less) per 100 ADSs (or portion of 100ADSs) | • Issue of ADSs, including issues resulting from a distribution of ordinary shares or rights or other property • Cancellation of ADSs for the purpose of withdrawal, including if the deposit agreement terminates | |
$0.05 (or less) per ADS | • Any cash distribution to you | |
A fee equivalent to the fee that would be payable if securities distributed to you had been ordinary shares and the shares had been deposited for issue of ADSs | • Distribution of securities distributed to holders of deposited securities which are distributed by the depositary to you | |
$0.05 (or less) per ADS per calendar year | • Depositary services | |
Registration or transfer fees | • Transfer and registration of ordinary shares on our share register to or from the name of the depositary or its agent when you deposit or withdraw shares | |
Expenses of the depositary | • Cable, telex and facsimile transmissions (when expressly provided in the deposit agreement) • Converting foreign currency to U.S. dollars | |
Taxes and other governmental charges the depositary or the custodian have to pay on any ADS or share underlying an ADS, for example, share transfer taxes, stamp duty or withholding taxes |
• As necessary | |
Any charges incurred by the depositary or its agents for servicing the deposited securities | • As necessary |
Item 13 |
Defaults, Dividend Arrearages and Delinquencies |
Item 14 |
Material Modification to the Rights of Security Holders and Use of Proceeds |
A. |
Material Modifications to the Rights of Securities Holders |
B. |
Use of Proceeds |
Item 15 |
Control and Procedures |
A. |
Disclosure Controls and Procedures |
B. |
Management’s Annual Report on Internal Control over Financial Reporting |
C. |
Attestation Report of the Registered Public Accounting Firm |
D. |
Changes in Internal Control over Financial Reporting |
Item 16A |
Audit Committee Financial Expert |
Item 16B |
Code of Ethics |
Item 16C |
Principal Accountant Fees and Services |
Year ended December 31, 2021 |
Year ended December 31, 2020 |
|||||||||||||||
EUR’000 |
%89 |
EUR’000 |
% |
|||||||||||||
Audit Fees |
771 | 89 | 599 | 83 | ||||||||||||
Tax Fees |
87 | 10 | 104 | 14 | ||||||||||||
All Other Fees |
13 | 1 | 22 | 3 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total |
871 |
100 |
725 |
100 |
||||||||||||
|
|
|
|
|
|
|
|
Item 16D |
Exemptions from the Listing Standards for Audit Committees |
Item 16E |
Purchases of Equity Securities by the Issuer and Affiliated Purchasers |
Period |
Total Number of ADSs Purchased |
Weighted Average Price Paid per ADS (US$)* |
Total Number of ADSs Purchased as Part of Publicly Announced Programs |
Maximum Number of Shares that May Yet Be Purchased Under the Plans or Programs | ||||
November 1, 2021 – November 9, 2021 |
154,837 | $161.46 | 154,837 | — |
Item 16F |
Change in Registrants Certifying Accountant |
Item 16G |
Corporate Governance |
• | We do not intend to follow Nasdaq’s quorum requirements applicable to meetings of shareholders. In accordance with Danish corporate law and generally accepted business practice, our articles of association do not provide quorum requirements generally applicable to general meetings of shareholders. |
• | We do not intend to follow Nasdaq’s requirements regarding the provision of proxy statements for general meetings of shareholders. Danish corporate law does not have a regulatory regime for the solicitation of proxies and the solicitation of proxies is not a generally accepted business practice in Denmark. We do intend to provide shareholders with an agenda and other relevant documents for the general meeting of shareholders. |
• | We do not intend to follow Nasdaq’s requirements regarding shareholder approval for certain issuances of securities under Nasdaq Rule 5635. Pursuant to Danish corporate law our shareholders have authorized our board of directors to issue securities including in connection with certain events such as the acquisition of shares or assets of another company, the establishment of or amendments to equity-based compensation plans for employees, a change of control of us, rights issues at or below market price, certain private placements and issuance of convertible notes. We intend to take all actions necessary for us to maintain compliance as a foreign private issuer under the applicable corporate governance requirements of the Sarbanes-Oxley Act of 2002, the rules adopted by the SEC and Nasdaq’s listing standards. As a Danish company not listed on a regulated market within the EU/EEA, we do not need to comply with the Danish corporate governance principles nor do we need to explain any deviation from these provisions in our Danish statutory annual report. |
• | We do not intend to follow Nasdaq’s requirements regarding shareholder approval for all equity compensation plans. Generally, Nasdaq Rule 5635(c) requires each issuer to obtain shareholder approval of all equity compensation plans (including warrant incentive plans) and material amendments to such plans. However, pursuant to Nasdaq Rule 5615(a)(3), we have elected to follow our home country’s practices (in this case, being Danish practices) in lieu of the requirements of Nasdaq Rule 5635(c). Our home country practices do not require us to obtain a shareholders’ approval for amendments to our existing warrant incentive program. |
Item 16H |
Mine Safety Disclosure |
Item 16I |
Disclosure Regarding Foreign Jurisdictions that Prevent Inspections |
Item 17 |
Financial Statements |
Item 18 |
Financial Statements |
Page |
||||
F-2 |
||||
F- 4 |
||||
F- 5 |
||||
F- 6 |
||||
F- 7 |
||||
F- 8 |
• |
We tested the effectiveness of controls over clinical trial accruals; |
• |
We obtained and read selected contract research organisation agreements, as well as amendments thereto; |
• |
We evaluated publicly available information (such as press releases and investor presentations) and Board of Directors’ materials regarding the status of clinical trial activities and compared this information to the judgements applied in recording the accruals and prepaid expenses; |
• |
For a selection of contracts, we compared the amount of accrual or prepaid expenses at the end of the prior period to current year activity and evaluated the appropriateness of the Company’s estimation methodology; |
• |
For a selection of open purchase orders, we assessed management’s judgements and estimates in determining whether an accrual or prepaid expense should be recorded; and |
• |
We made selections of specific amounts recognised as research and development expenses as well as those recognised as accruals and prepaid expenses and performed the following procedures: |
• |
We assessed management’s estimate of the vendors’ progress with Company clinical operations personnel; |
• |
We obtained the related statement of work, purchase order, or other supporting documentation (such as communications between the Company and vendors) and evaluated management’s judgments compared to the evidence obtained; and |
• |
We obtained the listing of all contracts related to research and development expenses to evaluate the completeness of accruals and prepaid expenses. |
Notes |
2021 |
2020 |
2019 |
|||||||||||||
(EUR’000) |
||||||||||||||||
Consolidated Statement of Profit or Loss |
|
|
|
|
|
|
|
|
|
|
|
| ||||
Revenue |
4 |
|
|
|
||||||||||||
Cost of sales |
||||||||||||||||
|
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|
|||||||||||
Gross profit |
||||||||||||||||
Research and development costs |
6, 11 |
|||||||||||||||
Selling, general and administrative expenses |
6, 11 |
|||||||||||||||
|
|
|
|
|
|
|||||||||||
Operating profit/(loss) |
( |
) |
( |
) |
( |
) | ||||||||||
Share of profit/(loss) of associate |
12 |
( |
) | ( |
) | |||||||||||
Finance income |
17 |
|||||||||||||||
Finance expenses |
17 |
|||||||||||||||
|
|
|
|
|
|
|||||||||||
Profit/(loss) before tax |
( |
) |
( |
) |
( |
) | ||||||||||
Tax on profit/(loss) for the year |
9 |
|||||||||||||||
|
|
|
|
|
|
|||||||||||
Net profit/(loss) for the year |
( |
) |
( |
) |
( |
) | ||||||||||
|
|
|
|
|
|
|||||||||||
Attributable to owners of the Company |
( |
) |
( |
) |
( |
) | ||||||||||
|
|
|
|
|
|
|||||||||||
Basic and diluted earnings/(loss) per share |
€ | ( |
) | € | ( |
) | € | ( |
) | |||||||
Weighted average number of shares used for calculation (basic and diluted) (1) |
||||||||||||||||
|
|
|
|
|
|
|||||||||||
(EUR’000) |
||||||||||||||||
Consolidated Statement of Comprehensive Income |
||||||||||||||||
Net profit/(loss) for the year |
( |
) |
( |
) |
( |
) | ||||||||||
Other comprehensive income/(loss) |
||||||||||||||||
Items that may be reclassified subsequently to profit or loss: |
||||||||||||||||
Exchange differences on translating foreign operations |
( |
) | ( |
) | ||||||||||||
|
|
|
|
|
|
|||||||||||
Other comprehensive income/(loss) for the year, net of tax |
( |
) |
( |
) | ||||||||||||
|
|
|
|
|
|
|||||||||||
Total comprehensive income/(loss) for the year, net of tax |
( |
) |
( |
) |
( |
) | ||||||||||
|
|
|
|
|
|
|||||||||||
Attributable to owners of the Company |
( |
) |
( |
) |
( |
) | ||||||||||
|
|
|
|
|
|
(1) | A total of warrants outstanding as of December 31, 2021 (a total of warrants and warrants outstanding as of December 31, 2020 and 2019, respectively) can potentially dilute earnings per share in the future but have not been included in the calculation of diluted earnings per share because they are antidilutive for the periods presented. |
Notes |
2021 |
2020 |
||||||||||
(EUR’000) |
||||||||||||
Assets |
|
|
|
|
|
|
|
|
| |||
Non-current assets |
||||||||||||
Intangible assets |
5, 10 |
|||||||||||
Property, plant and equipment |
5, 11 |
|
|
|||||||||
Investment in associate |
||||||||||||
Other receivables |
||||||||||||
Marketable securities |
||||||||||||
|
|
|
|
|||||||||
|
|
|
|
|||||||||
Current assets |
||||||||||||
Inventories |
13 |
|||||||||||
Trade receivables |
17 |
|||||||||||
Income tax receivables |
||||||||||||
Other receivables |
17 |
|||||||||||
Prepayments |
||||||||||||
Marketable securities |
17 |
|||||||||||
Cash and cash equivalents |
17 |
|||||||||||
|
|
|
|
|||||||||
|
|
|
|
|||||||||
Total assets |
||||||||||||
|
|
|
|
|||||||||
Equity and liabilities |
||||||||||||
Equity |
||||||||||||
Share capital |
17 |
|||||||||||
Distributable equity |
||||||||||||
|
|
|
|
|||||||||
Total equity |
||||||||||||
|
|
|
|
|||||||||
Non-current liabilities |
||||||||||||
Lease liabilities |
14, 17 |
|||||||||||
Contract liabilities |
15 |
|||||||||||
Other liabilities |
||||||||||||
|
|
|
|
|||||||||
|
|
|
|
|||||||||
Current liabilities |
||||||||||||
Lease liabilities |
14, 17 |
|||||||||||
Contract liabilities |
15 |
|||||||||||
Trade payables and accrued expenses |
17 |
|||||||||||
Other liabilities |
||||||||||||
Income tax payables |
||||||||||||
Provisions |
||||||||||||
|
|
|
|
|||||||||
|
|
|
|
|||||||||
Total liabilities |
||||||||||||
|
|
|
|
|||||||||
Total equity and liabilities |
||||||||||||
|
|
|
|
Share Capital |
Distributable Equity |
Total |
||||||||||||||||||||||||||
Share Premium |
Treasury shares |
Foreign Currency Translation Reserve |
Share-based Payment Reserve |
Accumulated Deficit |
||||||||||||||||||||||||
(EUR ‘000) |
||||||||||||||||||||||||||||
Equity at January 1, 2019 |
( |
) |
||||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||
Loss for the year |
— | — | — | ( |
) | ( |
) | |||||||||||||||||||||
Other comprehensive income/(loss), net of tax |
— | — | — | ( |
) | — | — | ( |
) | |||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||
Total comprehensive income/(loss) |
— |
— |
( |
) |
( |
) |
( |
) | ||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||
Transactions with Owners |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |||||||
Share-based payment (Note 7) |
— | — | — | |||||||||||||||||||||||||
Capital increase |
— | — | — | |||||||||||||||||||||||||
Cost of capital increase |
— | ( |
) | — | — | — | ( |
) | ||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||
Equity at December 31, 2019 |
( |
) |
( |
) |
||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||
Loss for the year |
— | — | — | — | ( |
) | ( |
) | ||||||||||||||||||||
Other comprehensive income/(loss), net of tax |
— | — | ( |
) | — | ( |
) | |||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||
Total comprehensive income/(loss) |
— |
— |
( |
) |
( |
) |
( |
) | ||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||
Transactions with Owners |
||||||||||||||||||||||||||||
Share-based payment (Note 7) |
— | — | — | |||||||||||||||||||||||||
Capital increase |
— | — | — | |||||||||||||||||||||||||
Cost of capital increase |
— | ( |
) | — | — | — | ( |
) | ||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||
Equity at December 31, 2020 |
( |
) |
( |
) |
||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||
Loss for the year |
— | — | — | — | ( |
) | ( |
) | ||||||||||||||||||||
Other comprehensive income/(loss), net of tax |
— | — | — | |||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||
Total comprehensive income/(loss) |
— |
— | ( |
) |
( |
) | ||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||
Transactions with Owners |
||||||||||||||||||||||||||||
Share-based payment (Note 7) |
— | — | — | |||||||||||||||||||||||||
Acquisition of treasury shares |
— | — | ( |
) | — | — | — | ( |
) | |||||||||||||||||||
Capital increase |
— | — | — | |||||||||||||||||||||||||
Cost of capital increase |
— | ( |
) | — | — | — | ( |
) | ||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||
Equity at December 31, 2021 |
( |
) |
( |
) |
||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Notes |
2021 |
2020 |
2019 |
|||||||||||||
(EUR’000) |
||||||||||||||||
Operating activities |
|
|
|
|
|
|
|
|
|
|
|
| ||||
Net profit/(loss) for the year |
|
|
|
|
( |
) |
( |
) |
( |
) | ||||||
Reversal of finance income |
|
|
|
|
( |
) | ( |
) | ( |
) | ||||||
Reversal of finance expenses |
|
|
|
|
|
|
|
|||||||||
Reversal of tax charge |
|
|
|
|
( |
) | ( |
) | ( |
) | ||||||
Increase/(decrease) in provisions |
|
|
|
|
— | — | ||||||||||
Adjustments for non-cash items: |
|
|
|
|
||||||||||||
Non-cash consideration regarding revenue |
|
|
|
|
( |
) | ( |
) | ( |
) | ||||||
Share of profit/(loss) of associate |
|
|
|
|
( |
) | ||||||||||
Share-based payment |
|
|
|
|
||||||||||||
Depreciation |
|
|
|
|
||||||||||||
Amortization |
|
|
|
|
— | — | ||||||||||
Changes in working capital: |
|
|
|
|
||||||||||||
Inventories |
|
|
13 |
|
( |
) | — | — | ||||||||
Receivables |
|
|
|
|
( |
) | ( |
) | ( |
) | ||||||
Prepayments |
|
|
|
|
( |
) | ( |
) | ||||||||
Contract liabilities (deferred income) |
|
|
|
|
( |
) | ( |
) | ||||||||
Trade payables, accrued expenses and other payables |
|
|
|
|
||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||
Cash flows generated from/(used in) operations |
|
|
|
|
( |
) |
( |
) |
( |
) | ||||||
Finance income received |
|
|
|
|
||||||||||||
Finance expenses paid |
|
|
|
|
( |
) | ( |
) | ( |
) | ||||||
Income taxes received/(paid) |
|
|
|
|
( |
) | ||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||
Cash flows from/(used in) operating activities |
|
|
|
|
( |
) |
( |
) |
( |
) | ||||||
|
|
|
|
|
|
|
|
|
|
|||||||
Investing activities |
|
|
|
|
||||||||||||
Investment in associate |
|
|
|
|
( |
) | — | — | ||||||||
Acquisition of property, plant and equipment |
|
|
|
|
( |
) | ( |
) | ( |
) | ||||||
Reimbursement for acquisition of property, plant and equipment |
|
|
|
|
— | — | ||||||||||
Development expenditures (software) |
|
|
|
|
( |
) | ( |
) | — | |||||||
Purchase of marketable securities |
|
|
|
|
( |
) | ( |
) | — | |||||||
Settlement of marketable securities |
|
|
|
|
— | |||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||
Cash flows from/(used in) investing activities |
|
|
|
|
( |
) |
( |
) |
( |
) | ||||||
|
|
|
|
|
|
|
|
|
|
|||||||
Financing activities |
|
|
|
|
||||||||||||
Payment of principal portion of lease liabilities |
|
|
|
|
( |
) | ( |
) | ( |
) | ||||||
Proceeds from exercise of warrants |
|
|
|
|
||||||||||||
Net proceeds from follow-on public offerings |
|
|
|
|
||||||||||||
Acquisitions of treasury shares, net of transaction costs |
|
|
|
|
( |
) | — | — | ||||||||
|
|
|
|
|
|
|
|
|
|
|||||||
Cash flows from/(used in) financing activities |
|
|
|
|
||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||
Increase/(decrease) in cash and cash equivalents |
|
|
|
|
( |
) |
||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||
Cash and cash equivalents at January 1 |
|
|
|
|
||||||||||||
Effect of exchange rate changes on balances held in foreign currencies |
|
|
|
|
( |
) | ||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||
Cash and cash equivalents at December 31 |
|
|
|
|
||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||
Cash and cash equivalents include: |
|
|
|
|
||||||||||||
Bank deposits |
|
|
|
|
||||||||||||
Short-term marketable securities |
|
|
|
|
— | |||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||
Cash and cash equivalents at December 31 |
|
|
|
|
||||||||||||
|
|
|
|
|
|
|
|
|
|
• | The contractual arrangement(s) with the other vote holders of the enterprise; |
• | The Company’s voting rights and potential voting rights; and |
• | Rights arising from other contractual arrangements. |
• | the customer can benefit from the good or service either on its own or together with other resources that are readily available to the customer (i.e., the good or service is capable of being distinct); and |
• | the entity’s promise to transfer the good or service to the customer is separately identifiable from other promises in the contract (i.e., the promise to transfer the good or service is distinct within the context of the contract). |
Process plant and machinery |
||||
Other equipment |
||||
Leasehold improvements |
||||
Right-of-use |
• | Determining whether the promises in the agreements are distinct performance obligations; |
• | Identifying and constraining variable consideration in the transaction price including milestone payments; |
• | Allocating transaction price to identified performance obligations based on their relative stand-alone selling prices; and |
• | Determining whether performance obligations are satisfied over time, or at a point in time. |
2021 |
2020 |
2019 |
||||||||||
(EUR’000) |
||||||||||||
Revenue from external customers |
|
|
|
|
|
|
|
|
| |||
Commercial sale of products |
|
— | — | |||||||||
Rendering of services |
||||||||||||
Sale of clinical supply |
||||||||||||
“Right-to-use” |
||||||||||||
|
|
|
|
|
|
|||||||
Total revenue |
||||||||||||
|
|
|
|
|
|
|||||||
Attributable to |
||||||||||||
Commercial customers |
— | — | ||||||||||
Collaboration partners and license agreements (1) |
||||||||||||
|
|
|
|
|
|
|||||||
Total revenue |
||||||||||||
|
|
|
|
|
|
|||||||
Specified by timing of recognition |
||||||||||||
Recognized over time |
||||||||||||
Recognized at a point in time |
||||||||||||
|
|
|
|
|
|
|||||||
Total revenue |
||||||||||||
|
|
|
|
|
|
|||||||
Specified per geographical location |
||||||||||||
North America |
||||||||||||
China |
||||||||||||
|
|
|
|
|
|
|||||||
Total revenue |
||||||||||||
|
|
|
|
|
|
(1) | Revenue from collaboration partners and license agreements includes recognition of previously deferred revenue/internal profit from associate of € million, € million and € million for the years ended December 31, 2021, 2020 and 2019, respectively. Revenue from one collaboration partner amounted to % of total revenue from collaboration partners and license agreements. |
2021 |
2020 |
|||||||
(EUR’000) |
||||||||
Non-current segment assets |
|
|
|
|
|
| ||
Denmark (domicile country) |
||||||||
North America |
||||||||
Germany |
||||||||
|
|
|
|
|||||
Total non-current segment assets |
||||||||
|
|
|
|
|||||
Investment in associate |
||||||||
Marketable securities |
||||||||
Other receivables |
||||||||
|
|
|
|
|||||
Total non-current assets |
||||||||
|
|
|
|
2021 |
2020 |
2019 |
||||||||||
(EUR’000) |
||||||||||||
Employee costs |
|
|
|
|
|
|
|
|
| |||
Wages and salaries |
||||||||||||
Share-based payment |
||||||||||||
Pensions (defined contribution plans) |
||||||||||||
Social security costs |
||||||||||||
|
|
|
|
|
|
|||||||
Total employee costs |
||||||||||||
|
|
|
|
|
|
|||||||
Included in the profit or loss |
— |
— |
— |
|||||||||
Cost of sales |
— | — | ||||||||||
Research and development costs |
||||||||||||
Selling, general and administrative expenses |
||||||||||||
|
|
|
|
|
|
|||||||
Total employee costs |
||||||||||||
|
|
|
|
|
|
|||||||
Average number of employees |
||||||||||||
|
|
|
|
|
|
Board of Directors (1) |
Executive Board (2) |
Non-executive Senior Management |
||||||||||||||||||||||||||||||||||
2021 |
2020 |
2019 |
2021 |
2020 |
2019 |
2021 |
2020 |
2019 |
||||||||||||||||||||||||||||
(EUR ‘000) |
||||||||||||||||||||||||||||||||||||
Compensation |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |||||||||
Wages and salaries |
||||||||||||||||||||||||||||||||||||
Share-based payment |
||||||||||||||||||||||||||||||||||||
Pensions (defined contribution plans) |
— | — | — | — | — | |||||||||||||||||||||||||||||||
Social security costs |
— | — | — | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||
Total compensation |
||||||||||||||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
The Board of Directors comprised to persons in 2021. At December 31, 2021, the Board of Directors comprised persons. For 2020 and 2019, the Board of Directors comprised persons. |
(2) | The Executive Board comprised |
Total RSUs |
Fair Value EUR |
|||||||
Outstanding at January 1, 2021 |
||||||||
|
|
|
|
|||||
Granted, December 2021 |
||||||||
|
|
|
|
|||||
Outstanding at December 31, 2021 |
||||||||
|
|
|
|
|||||
Vested at the reporting date |
||||||||
|
|
|
|
Total Warrants |
Weighted Average Exercise Price EUR |
|||||||
Outstanding at January 1, 2019 |
||||||||
|
|
|
|
|||||
Granted during the year |
||||||||
Exercised during the year (1) |
( |
) | ||||||
Forfeited during the year |
( |
) | ||||||
Expired during the year |
||||||||
|
|
|
|
|||||
Outstanding at December 31, 2019 |
||||||||
|
|
|
|
|||||
Vested at the reporting date |
||||||||
|
|
|
|
|||||
Granted during the year |
||||||||
Exercised during the year (1) |
( |
) | ||||||
Forfeited during the year |
( |
) | ||||||
Expired during the year |
||||||||
|
|
|
|
|||||
Outstanding at December 31, 2020 |
||||||||
|
|
|
|
|||||
Vested at the reporting date |
||||||||
|
|
|
|
|||||
Granted during the year |
||||||||
Exercised during the year (1) |
( |
) | ||||||
Forfeited during the year |
( |
) | ||||||
Expired during the year |
||||||||
|
|
|
|
|||||
Outstanding at December 31, 2021 |
||||||||
|
|
|
|
|||||
Vested at the reporting date |
||||||||
|
|
|
|
(1) | The weighted average share price (listed in $) at the date of exercise was € |
Number of Outstanding Warrants |
Weighted Average Exercise Price EUR |
Weighted Average Remaining Life (months) |
||||||||||
Granted in |
||||||||||||
Granted in |
||||||||||||
Granted in |
||||||||||||
Granted in |
||||||||||||
Granted in |
||||||||||||
|
|
|
|
|
|
|||||||
Outstanding at December 31, 2021 |
||||||||||||
|
|
|
|
|
|
|||||||
|
|
|
|
|
|
|
|
|
2021 |
2020 |
2019 |
||||||||||
Expected volatility |
||||||||||||
Risk-free interest rate |
( |
( |
( |
|||||||||
Expected life of warrants (years) |
|
|||||||||||
Weighted average exercise price |
€ | € | € | |||||||||
Fair value of warrants granted in the year |
€ | € | € | |||||||||
|
|
|
|
|
|
|
|
|
2021 |
2020 |
2019 |
||||||||||
(EUR’000) |
||||||||||||
Principal accountant fees and services |
|
|
|
|
|
|
|
|
| |||
Audit fees |
||||||||||||
Tax fees |
||||||||||||
All other fees |
— | |||||||||||
|
|
|
|
|
|
|||||||
Total principal accountant fees and services |
2021 |
2020 |
2019 |
||||||||||
(EUR’000) |
||||||||||||
Tax on profit/(loss) for the year: |
|
|
|
|
|
|
|
|
| |||
Current tax (expense)/income |
||||||||||||
|
|
|
||||||||||
2021 |
2020 |
2019 | ||||||||||
(EUR’000) | ||||||||||||
Tax for the year can be explained as follows: |
||||||||||||
Profit/(loss) before tax |
|
( |
) | |
( |
) | |
( |
) | |||
Tax at the Danish corporation tax rate of |
|
|
|
|||||||||
Tax effect of: |
|
|
|
|||||||||
Non-deductible costs |
|
( |
) | |
( |
) | |
( |
) | |||
Additional tax deductions |
|
|
|
|||||||||
Impact from associate |
|
|
( |
) | |
( |
) | |||||
Other effects including effect of different tax rates |
|
|
|
|||||||||
Deferred tax asset, not recognized |
|
( |
) | |
( |
) | |
( |
) | |||
|
|
|
|
|
|
|||||||
Tax on profit/(loss) for the year |
|
|
|
|||||||||
|
|
|
|
|
|
|||||||
Effective tax rate |
|
( |
|
( |
|
( |
||||||
2021 |
2020 |
2019 | ||||||||||
(EUR’000) | ||||||||||||
Specification of Deferred Tax Assets |
||||||||||||
Tax deductible losses |
||||||||||||
Other temporary differences |
||||||||||||
Deferred tax asset, not recognized |
( |
) |
( |
) |
( |
) | ||||||
|
|
|
||||||||||
Total Deferred Tax Assets at December 31 |
||||||||||||
|
|
|
Goodwill |
Software |
Total |
||||||||||
(EUR’000) |
||||||||||||
Cost: |
|
|
|
|
|
|
|
|
| |||
At January 1, 2020 |
||||||||||||
Additions |
||||||||||||
Disposals |
||||||||||||
Foreign exchange translation |
||||||||||||
|
|
|
|
|
|
|||||||
At December 31, 2020 |
||||||||||||
|
|
|
|
|
|
|||||||
Additions |
||||||||||||
Disposals |
||||||||||||
Foreign exchange translation |
||||||||||||
|
|
|
|
|
|
|||||||
At December 31, 2021 |
||||||||||||
|
|
|
|
|
|
|||||||
Accumulated amortization and impairments: |
||||||||||||
At January 1, 2020 |
||||||||||||
Amortization charge |
||||||||||||
Impairment charge |
||||||||||||
Disposals |
||||||||||||
Foreign exchange translation |
||||||||||||
|
|
|
|
|
|
|||||||
At December 31, 2020 |
||||||||||||
|
|
|
|
|
|
|||||||
Amortization charge |
( |
) | ( |
) | ||||||||
Impairment charge |
||||||||||||
Disposals |
||||||||||||
Foreign exchange translation |
||||||||||||
|
|
|
|
|
|
|||||||
At December 31, 2021 |
( |
) |
( |
) | ||||||||
|
|
|
|
|
|
|||||||
Carrying amount: |
||||||||||||
At December 31, 2020 |
||||||||||||
|
|
|
|
|
|
|||||||
At December 31, 2021 |
Plant and Machinery |
Other Equipment |
Leasehold Improve- ments |
Right-of-Use Assets |
Total |
||||||||||||||||
(EUR’000) |
||||||||||||||||||||
Cost: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |||||
At January 1, 2020 |
||||||||||||||||||||
Additions |
|
|
|
|
||||||||||||||||
Disposals |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||||||
Foreign exchange translation |
( |
) | ( |
) | ( |
) | ( |
) | ( |
) | ||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||
At December 31, 2020 |
||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||
Additions |
||||||||||||||||||||
Disposals |
( |
) | ( |
) | — | ( |
) | ( |
) | |||||||||||
Foreign exchange translation |
||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||
At December 31, 2021 |
||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||
Accumulated depreciation: |
||||||||||||||||||||
At January 1, 2020 |
( |
) |
( |
) |
( |
) |
( |
) |
( |
) | ||||||||||
Depreciation charge |
( |
) | ( |
) | ( |
) | ( |
) | ( |
) | ||||||||||
Disposals |
— | |||||||||||||||||||
Foreign exchange translation |
||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||
At December 31, 2020 |
( |
) |
( |
) |
( |
) |
( |
) |
( |
) | ||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||
Depreciation charge |
( |
) | ( |
) | ( |
) | ( |
) | ( |
) | ||||||||||
Disposals |
— | |||||||||||||||||||
Foreign exchange translation |
( |
) | ( |
) | ( |
) | ( |
) | ( |
) | ||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||
At December 31, 2021 |
( |
) |
( |
) |
( |
) |
( |
) |
( |
) | ||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||
Carrying amount: |
||||||||||||||||||||
At December 31, 2020 |
||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||
At December 31, 2021 |
||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
2021 |
2020 |
2019 |
||||||||||
(EUR’000) |
||||||||||||
Depreciation charges |
|
|
|
|
|
|
|
|
| |||
Cost of sales |
— | — | ||||||||||
Research and development costs |
||||||||||||
Selling, general and administrative expenses |
|
|
|
|||||||||
|
|
|
|
|
|
|||||||
Total depreciation charges |
||||||||||||
|
|
|
|
|
|
VISEN Pharmaceuticals |
||||||||
Principal place of business | ||||||||
2021 |
2020 |
|||||||
(EUR’000) |
||||||||
Statement of profit or loss |
||||||||
Profit/(loss) for the year from continuing operations |
( |
) |
( |
) | ||||
Total comprehensive income |
( |
) |
( |
) | ||||
Statement of financial position |
||||||||
Non-current assets |
|
|
||||||
Current assets |
||||||||
Total assets |
||||||||
Equity |
||||||||
Non-current liabilities |
||||||||
Current liabilities |
||||||||
Total equity and liabilities |
||||||||
Company’s share of equity before eliminations |
||||||||
Elimination of internal profit and other equity method adjustments |
( |
) |
( |
) | ||||
Company’s share of equity |
||||||||
Investment in associate at December 31 |
||||||||
Present ownership at December 31 |
||||||||
Transactions and outstanding balances as of December 31 |
||||||||
Sale of goods and services to associate |
|
|
||||||
Trade receivables from associate |
||||||||
Contract liabilities |
||||||||
2021 |
||||
(EUR’000) |
||||
Inventories |
||||
Raw materials and consumables |
||||
Work in progress |
||||
Finished goods |
||||
Total inventories |
||||
Beginning of period |
Cash payments |
Non-cash items |
End of period |
|||||||||||||||||||||||||
Payment of principal portion of liabilities |
Payment of interest |
Additions |
Accretion of interest |
Foreign exchange adjustment |
||||||||||||||||||||||||
(EUR’000) |
||||||||||||||||||||||||||||
Lease liabilities |
||||||||||||||||||||||||||||
December 31, 2021 |
|
( |
) | ( |
) | |
|
|
||||||||||||||||||||
December 31, 2020 |
( |
) | ( |
) | ( |
) | |
|||||||||||||||||||||
2021 |
2020 |
2019 |
||||||||||
(EUR’000) |
||||||||||||
Lease expense |
|
|
|
|
|
|
|
|
| |||
Depreciation |
||||||||||||
Expenses relating to short term leases and leases of low value assets |
||||||||||||
Lease interest |
||||||||||||
|
|
|
|
|
|
|||||||
Total lease expenses |
||||||||||||
|
|
|
|
|
|
2021 |
2020 |
|||||||
(EUR’000) |
||||||||
Financial assets |
|
|
|
|
|
| ||
Trade receivables |
||||||||
Other receivables |
||||||||
Marketable securities |
||||||||
Cash and cash equivalents |
||||||||
|
|
|
|
|||||
Financial assets measured at amortized cost |
||||||||
|
|
|
|
|||||
Financial liabilities |
||||||||
Lease liabilities |
||||||||
Trade payables and accrued expenses |
|
|
||||||
|
|
|
|
|||||
Financial liabilities measured at amortized cost |
||||||||
|
|
|
|
2021 |
2020 |
2019 |
||||||||||
(EUR’000) |
||||||||||||
Finance income |
|
|
|
|
|
|
|
|
| |||
Interest income |
||||||||||||
Exchange rate gains |
— | |||||||||||
|
|
|
|
|
|
|||||||
Total finance income |
||||||||||||
|
|
|
|
|
|
|||||||
Finance expenses |
||||||||||||
Interest expenses |
|
|
|
|||||||||
Exchange rate losses |
— | — | ||||||||||
|
|
|
|
|
|
|||||||
Total finance expenses |
||||||||||||
|
|
|
|
|
|
2021 |
2020 |
2019 |
2018 |
2017 |
||||||||||||||||
Changes in share capital |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |||||
At January 1 |
||||||||||||||||||||
Increase through cash contributions |
||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||
At December 31 |
||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
Nominal value |
Holding |
Holding in % of total outstanding shares |
||||||||||
(EUR’000) |
(Number) |
|||||||||||
Treasury shares |
|
|
|
|
|
|
||||||
At January 1, 2021 |
||||||||||||
Acquired from third-parties |
||||||||||||
|
|
|
|
|
|
|||||||
At December 31, 2021 |
||||||||||||
|
|
|
|
|
|
Nominal positions (net) |
Hypothetical impact on consolidated financial statements |
|||||||||||||||
Increase in foreign currency exchange rate |
Profit and loss before tax |
Equity before tax |
||||||||||||||
(EUR ‘000) |
||||||||||||||||
December 31, 2021 |
|
|
|
|
|
|
|
|
|
|
|
| ||||
USD/EUR |
|
|
|
|||||||||||||
GBP/EUR |
||||||||||||||||
December 31, 2020 |
||||||||||||||||
USD/EUR |
||||||||||||||||
GBP/EUR |
|
December 31, 2021 |
December 31, 2020 |
|||||||||||||||
Carrying amount |
Fair value |
Carrying amount |
Fair value |
|||||||||||||
(EUR’000) |
||||||||||||||||
Marketable securities specified by rate structure |
|
|
|
|
|
|
|
|
|
|
|
| ||||
Fixed rate |
||||||||||||||||
Floating rate |
||||||||||||||||
Zero-coupon |
||||||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total marketable securities |
||||||||||||||||
|
|
|
|
|
|
|
|
December 31, 2021 |
December 31, 2020 |
|||||||||||||||
Carrying amount |
Fair value |
Carrying amount |
Fair value |
|||||||||||||
(EUR’000) |
||||||||||||||||
Marketable securities specified by investment grade credit rating |
|
|
|
|
|
|
|
|
|
|
|
| ||||
Prime |
||||||||||||||||
High grade |
||||||||||||||||
Upper medium grade |
||||||||||||||||
Lower medium grade |
||||||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total marketable securities |
||||||||||||||||
|
|
|
|
|
|
|
|
December 31, 2021 |
December 31, 2020 |
|||||||||||||||
Carrying amount |
Fair value |
Carrying amount |
Fair value |
|||||||||||||
(EUR’000) |
||||||||||||||||
Marketable securities specified by security type |
|
|
|
|
|
|
|
|
|
|
|
| ||||
U.S. Treasury bills |
— | — | ||||||||||||||
U.S. Government bonds |
||||||||||||||||
Commercial papers |
||||||||||||||||
Corporate bonds |
||||||||||||||||
Agency bonds |
||||||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total marketable securities |
||||||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Classified based on maturity profiles |
||||||||||||||||
Non-current assets |
||||||||||||||||
Current assets |
||||||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total marketable securities |
||||||||||||||||
|
|
|
|
|
|
|
|
< 1 year |
1-5 years |
>5 years |
Total contractual cash-flows |
Carrying amount |
||||||||||||||||
(EUR’000) |
||||||||||||||||||||
December 31, 2021 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |||||
Lease liabilities |
||||||||||||||||||||
Trade payables and accrued expenses |
||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||
Total financial liabilities |
||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
< 1 year |
1-5 years |
>5 years |
Total contractual cash-flows |
Carrying amount |
||||||||||||||||
(EUR’000) |
||||||||||||||||||||
December 31, 2020 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |||||
Lease liabilities |
||||||||||||||||||||
Trade payables and accrued expenses |
||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||
Total financial liabilities |
||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
Subsidiaries |
Domicile |
Ownership |
||||
|
||||||
|
||||||
|
||||||
|
||||||
|
||||||
|
||||||
|
||||||
|
||||||
|
|
|
|
|
| |
Associate |
Domicile |
Ownership |
||||
|
• | |
• | |
• | |
• | |
• | |
• | |
• | |
Item 19 |
Exhibits |
Exhibit Number |
Exhibit Description |
Incorporated by Reference |
||||||||||
Form |
Date |
Number |
File Number |
Provided Herewith | ||||||||
13.1 | Certification by Principal Executive Officer Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. | X | ||||||||||
13.2 | Certification by Principal Financial Officer Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. | X | ||||||||||
15.1 | Consent of Independent Registered Public Accounting Firm. | X | ||||||||||
EX-101.INS |
Inline XBRL Instance Document. | X | ||||||||||
EX-101.SCH |
Inline XBRL Taxonomy Extension Schema Document. | X | ||||||||||
EX-101.CAL |
Inline XBRL Taxonomy Extension Calculation Linkbase Document. | X | ||||||||||
EX-101.DEF |
Inline XBRL Taxonomy Extension Definition Linkbase Document. | X | ||||||||||
EX-101.IAB |
Inline XBRL Taxonomy Extension Labels Linkbase Document. | X | ||||||||||
EX-101.PRE |
Inline XBRL Taxonomy Extension Presentation Linkbase Document. | X | ||||||||||
104 | Cover page interactive data file (formatted as Inline XBRL and included in Exhibit 101). | X |
† | Confidential treatment has been granted for certain information contained in this Exhibit. Such information has been omitted and filed separately with the SEC. |
* | Portions of this exhibit (indicated by asterisks) have been omitted pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and is the type that the registrant treats as private or confidential. |
Ascendis Pharma A/S | ||
By: | /s/ Jan Møller Mikkelsen | |
Jan Møller Mikkelsen | ||
President, Chief Executive Officer and Board Member (Principal Executive Officer) | ||
Date: March 2, 2022 | ||
By: | /s/ Scott T. Smith | |
Scott T. Smith | ||
Senior Vice President, Chief Financial Officer (Principal Financial Officer) | ||
Date: March 2, 2022 |