Annual and transition report of foreign private issuers [Sections 13 or 15(d)]



>
















UNITED STATES




SECURITIES AND EXCHANGE COMMISSION




Washington, D.C. 20549








FORM 20‑F




(Mark One)









REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934




OR







ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934




For the fiscal year ended December 31, 2018




OR









TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934




For the transition period from




to




.




OR









SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934




Date of event requiring this shell company report




Commission file number: 001‑36619




AFFIMED N.V.




(


Exact name of Registrant as specified in its charter


)




The Netherlands




(


Jurisdiction of incorporation or organization


)




Technologiepark, Im Neuenheimer Feld 582




69120 Heidelberg, Germany,




(+49) 6221‑6743‑60




(


Address of principal executive offices


)




Florian Fischer, CFO




Tel: (+49) 6221‑6743‑60




Technologiepark, Im Neuenheimer Feld 582




69120 Heidelberg, Germany




(


Name, Telephone, E-mail and/or Facsimile number and Address of Company Contact Person


)




Copy to


:




Derek Dostal




Davis Polk & Wardwell LLP




450 Lexington Avenue




New York, NY 10017




Phone: (212) 450‑4000




Fax: (212) 701‑5800




Securities registered or to be registered pursuant to Section 12(b) of the Act:





















Title of each class










Name of each exchange on which registered





Common shares, nominal value €0.01 per share










The NASDAQ Stock Market LLC



































Securities registered or to be registered pursuant to Section 12(g) of the Act:




None




(Title of Class)




Securities for which there is a reporting obligation pursuant to Section 15(d) of the Act:




None




(Title of Class)




Indicate the number of outstanding shares of each of the issuer’s classes of capital stock or common stock as of the close of the period covered by the annual report.




Common shares: 62,430,106




Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.







Yes





No




If this report is an annual or transition report, indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934.







Yes





No




Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.







Yes





No




Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).







Yes





No (not required)




Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, or a non-accelerated filer. See definition of “accelerated filer and large accelerated filer” in Rule 12b‑2 of the Exchange Act.:





































Large Accelerated Filer








Accelerated Filer








Non-accelerated Filer


















Emerging growth company













If an emerging growth company that prepares its financial statements in accordance with U.S. GAAP, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards† provided pursuant to Section 13(a) of the Exchange Act.







†  The term “new or revised financial accounting standard” refers to any update issued by the Financial Accounting Standards Board to its Accounting Standards Codification after April 5, 2012.




Indicate by check mark which basis of accounting the registrant has used to prepare the financial statements included in this filing:
















U.S. GAAP












International Financial Reporting


Standards as issued by the International


Accounting Standards Board












Other













If “Other” has been checked in response to the previous question, indicate by check mark which financial statement item the registrant has elected to follow.







Item 17





Item 18




If this is an annual report, indicate by check mark whether the registrant is a shell company (as defined in Rule 12b‑2 of the Exchange Act).







Yes





No











































TABLE OF CONTENTS














































































































































































































































































PAGE






FORWARD-LOOKING STATEMENTS








iii






PART I








1




ITEM 1. IDENTITY OF DIRECTORS, SENIOR MANAGEMENT AND ADVISERS








1




A.









Directors and senior management






1




B.









Advisers






1




C.









Auditors






1




ITEM 2. OFFER STATISTICS AND EXPECTED TIMETABLE








1




A.









Offer statistics






1




B.









Method and expected timetable






1




ITEM 3. KEY INFORMATION








1




A.









Selected Financial Data






1




B.









Capitalization and indebtedness






2




C.









Reasons for the offer and use of proceeds






2




D


.







Risk factors






2




ITEM 4. INFORMATION ON THE COMPANY








48




A.









History and development of the company






48




B.









Business overview






49




C.









Organizational structure






92




D.









Property, plant and equipment






93




ITEM 4A. UNRESOLVED STAFF COMMENTS








93




ITEM 5. OPERATING AND FINANCIAL REVIEW AND PROSPECTS








93




A.









Operating results






93




B.









Liquidity and Capital Resources






104




C.









Research and development, patents and licenses, etc.






107




D.









Trend information






107




E.









Off-balance sheet arrangements






107




F.









Tabular disclosure of contractual obligations






107




G.









Safe harbor






108




ITEM 6. DIRECTORS, SENIOR MANAGEMENT AND EMPLOYEES








108




A.









Directors and senior management






108




B.









Compensation






112




C.









Board practices






116




D.









Employees






118




E.









Share ownership






118




ITEM 7. MAJOR SHAREHOLDERS AND RELATED PARTY TRANSACTIONS








118




A.









Major shareholders






118




B.









Related party transactions






121




C.









Interests of Experts and Counsel






122




ITEM 8. FINANCIAL INFORMATION








123




A.









Consolidated statements and other financial information






123




B.









Significant changes






123




ITEM 9. THE OFFER AND LISTING








123




A.









Offering and listing details






123




B.









Plan of distribution






123




C.









Markets






123




D.









Selling shareholders






123




E.









Dilution






123




F.









Expenses of the issue






124























i

















































































































































































































ITEM 10. ADDITIONAL INFORMATION








124




A.









Share capital






124




B.









Memorandum and articles of association






124




C.









Material contracts






124




D.









Exchange controls






124




E.









Taxation






124




F.









Dividends and paying agents






142




G.









Statement by experts






142




H.









Documents on display






142




I.









Subsidiary information






142




ITEM 11. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT RISK








142




ITEM 12. DESCRIPTION OF SECURITIES OTHER THAN EQUITY SECURITIES








142




A.









Debt securities






142




B.









Warrants and rights






142




C.









Other securities






143




D.









American Depositary Shares






143




PART II













143




ITEM 13. DEFAULTS, DIVIDEND ARREARAGES AND DELINQUENCIES








143




A.









Defaults






143




B.









Arrears and delinquencies






143




ITEM 14. MATERIAL MODIFICATIONS TO THE RIGHTS OF SECURITY HOLDERS AND USE OF PROCEEDS








143




A.









Use of Proceeds






143




ITEM 15. CONTROLS AND PROCEDURES








143




A.









Disclosure Controls and Procedures






143




B.









Management’s Annual Report on Internal Control over Financial Reporting






144




C.









Attestation Report of the Registered Public Accounting Firm






144




D.









Changes in Internal Control over Financial Reporting






144




ITEM 16. [RESERVED]








144




ITEM 16A. Audit committee financial expert








144




ITEM 16B. Code of ethics








144




ITEM 16C. Principal Accountant Fees and Services








145




ITEM 16D. Exemptions from the listing standards for audit committees








145




ITEM 16E. Purchases of equity securities by the issuer and affiliated purchasers








145




ITEM 16F. Change in registrant’s certifying accountant








145




ITEM 16G. Corporate governance








146




ITEM 16H. Mine safety disclosure








146




PART III








147




ITEM 17. Financial statements








147




ITEM 18. Financial statements








147




ITEM 19. Exhibits








147








Unless otherwise indicated or the context otherwise requires, all references in this Annual Report on Form 20‑F (the “Annual Report”) to “Affimed N.V.” or “Affimed,” the “Company,” “we,” “our,” “ours,” “us” or similar terms refer to Affimed N.V., together with its subsidiaries.




TRADEMARKS




ROCK


®


is our registered trademark. The trademarks, trade names and service marks appearing in this Annual Report are property of their respective


owners.























ii




















FORWARD-LOOKING STATEMENTS






This Annual Report contains statements that constitute forward-looking statements. Many of the forward-looking statements contained in this Annual Report can be identified by the use of forward-looking words such as “anticipate,” “believe,” “could,” “expect,” “should,” “plan,” “intend,” “will,” “estimate” and “potential,” among others.




Forward-looking statements appear in a number of places in this Annual Report and include, but are not limited to, statements regarding our intent, belief or current expectations. Forward-looking statements are based on our management’s beliefs and assumptions and on information currently available to our management. Such statements are subject to risks and uncertainties, and actual results may differ materially from those expressed or implied in the forward-looking statements due to various factors, including, but not limited to, those identified under the section “Item 3. Key Information—D. Risk factors” in this Annual Report. These risks and uncertainties include factors relating to:
















·








our operation as a development stage company with limited operating history and a history of operating losses; as of December 31, 2018, our accumulated deficit was €202.1 million;


















·








the chance our clinical trials may be delayed or put on clinical hold, for example, due to slower than expected enrollment or regulatory actions, or not be successful and clinical results may not reflect results seen in previously conducted preclinical studies and clinical trials;


















·








our reliance on contract manufacturers and contract research organizations over which we have limited control;


















·








our lack of adequate funding to complete development of our product candidates and the risk we may be unable to access additional capital on reasonable terms or at all to complete development and begin commercialization of our product candidates;


















·








our dependence on the success of AFM13 and certain of our other product candidates, which are still in clinical development and may eventually prove to be unsuccessful or commercially not exploitable;


















·








uncertainty surrounding whether any of our product candidates will gain regulatory approval, which is necessary before they can be commercialized;


















·








the outcome of any, or any discussions we may enter regarding, acquisitions, dispositions, partnerships, license transactions or changes to our capital structure, including our receipt of any milestone payments or royalties or any future securities offerings;


















·








the chance that we may become exposed to costly and damaging liability claims resulting from the testing of our product candidates in the clinic or in the commercial stage;


















·








if our product candidates obtain regulatory approval, or being subject to expensive ongoing obligations and continued regulatory overview;


















·








enacted and future legislation may increase the difficulty and cost for us to obtain marketing approval and commercialization;


















·








the chance that our products may not gain market acceptance, in which case we may not be able to generate product revenues;

















iii
































·








our reliance on our current strategic relationships with LLS, Merck, The MD Anderson Cancer Center, Genentech, Amphivena and Amphivena’s other investors and partners, including MPM Capital and Tekla Capital Management, and the potential failure to enter into new strategic relationships;


















·








our reliance on third parties to conduct our nonclinical and clinical trials and on third-party single-source suppliers to supply or produce our product candidates;


















·








our ability to scale-up manufacturing processes of our product candidates and reduce the cost of manufacturing our product candidates in advance of any commercialization;


















·








our future growth and ability to compete, which depends on retaining our key personnel and recruiting additional qualified personnel; and


















·








other risk factors discussed under “Item 3. Key Information—D. Risk factors.”






Forward-looking statements speak only as of the date they are made, and we do not undertake any obligation to update them in light of new information or future developments or to release publicly any revisions to these statements in order to reflect later events or circumstances or to reflect the occurrence of unanticipated events.





















iv




















PART I






ITEM 1. IDENTITY OF DIRECTORS, SENIOR MANAGEMENT AND ADVISERS






A.   Directors and senior management






Not applicable.




B.   Advisers






Not applicable.




C.   Auditors






Not applicable.




ITEM 2. OFFER STATISTICS AND EXPECTED TIMETABLE






A.   Offer statistics






Not applicable.




B.   Method and expected timetable






Not applicable.




ITEM 3. KEY INFORMATION






A.   Selected Financial Data






The comprehensive loss and financial position data as of and for the years ended December 31, 2014, 2015, 2016, 2017 and 2018 of Affimed N.V. are derived from our consolidated financial statements. We maintain our books and records in euros, and we prepare our financial statements under International Financial Reporting Standards as issued by the International Accounting Standards Board (“IFRS”).




Financial information presented in the consolidated financial statements of Affimed N.V. for periods prior to the corporate reorganization on September 17, 2014 is that of Affimed Therapeutics AG, Heidelberg, Germany, and its subsidiary.















1




















This financial information should be read in conjunction with “Item 5—Operating and Financial Review and Prospects” and our consolidated audited financial statements, including the notes thereto, included in this Annual Report.



































































































































































































































































Consolidated Statements of Comprehensive Loss Data


For the years ended December 31,





(in thousands of € except for per share data)










2014










2015










2016










2017










2018





Revenue










3,382










7,562










6,314










2,010










23,735





Other income/(expenses)—net










381










651










145










205










1,515





Research and development expenses










(9,595)








(22,008)








(30,180)








(21,489)








(35,148)



General and administrative expenses










(2,346)








(7,548)








(8,323)








(7,986)








(9,638)



Operating loss










(8,178)








(21,343)








(32,044)








(27,260)








(19,536)



Finance income/(costs)—net










7,753










1,104










(230)








(2,893)








60





Loss before tax










(425)








(20,239)








(32,274)








(30,243)








(19,476)



Income taxes










166










0










58










20










(1)



Loss for the period










(259)








(20,239)








(32,216)








(30,223)








(19,477)



Other comprehensive income










0










0










0










0










(4,731)



Total comprehensive loss










(259)








(20,239)








(32,216)








(30,223)








(24,208)



Loss per share in € per share










(0.01)








(0.71)








(0.97)








(0.69)








(0.32)





























































































































































































As of December 31,





(in thousands of €)










2014










2015










2016










2017










2018





Cash and cash equivalents










39,725










76,740










35,407










39,837










94,829





Financial assets










0










0










9,487










0










13,974





Total assets










41,909










79,322










48,739










43,158










116,174





Total liabilities










10,114










12,048










9,988










11,579










76,045



Accumulated deficit










(99,989)








(120,228)








(152,444)








(182,667)








(202,144)



Total equity










31,795










67,274










38,751










31,579










40,129








B.   Capitalization and indebtedness






Not applicable.




C.   Reasons for the offer and use of proceeds






Not applicable.




D.   Risk factors






You should carefully consider the risks and uncertainties described below and the other information in this Annual Report before making an investment in our common shares. Our business, financial condition or results of operations could be materially and adversely affected if any of these risks occurs, and as a result, the market price of our common shares could decline and you could lose all or part of your investment. This Annual Report also contains forward-looking statements that involve risks and uncertainties. See “Forward-Looking Statements.” Our actual results could differ materially and adversely from those anticipated in these forward-looking statements as a result of certain factors.















2




















Risks Related to Our Business and the Development and Commercialization of Our Product Candidates




All of our product candidates are in preclinical or clinical development. Drug development is expensive, time consuming and uncertain, and we may ultimately not be able to obtain regulatory approvals for the commercialization of some or all of our product candidates.




The research, testing, manufacturing, labeling, approval, selling, marketing and distribution of drug products are subject to extensive regulation by the U.S. Food and Drug Administration, or FDA, the European Medicines Agency, or EMA, national competent authorities in Europe, including the Paul-Ehrlich-Institut, or PEI, and other non-U.S. regulatory authorities, which establish regulations that differ from country to country. We are not permitted to market our product candidates in the United States or in other countries until we receive approval of a Biologics License Application, or BLA, from the FDA or marketing approval from applicable regulatory authorities outside the United States. Our product candidates are in various stages of development and are subject to the risks of failure inherent in drug development. We have not submitted an application for or received marketing approval for any of our product candidates. We have limited experience in conducting and managing the clinical studies necessary to obtain regulatory approvals, including approval by the FDA or the European Commission. Obtaining approval of a BLA or a Marketing Authorization Application can be a lengthy, expensive and uncertain process. In addition, failure to comply with FDA, EMA and other non-U.S. regulatory requirements may, either before or after product approval, if any, subject our company to administrative or judicially imposed sanctions, including:
















·








restrictions on our ability to conduct clinical studies, including full or partial clinical holds, or other regulatory objections to, ongoing or planned trials;


















·








restrictions on the products, manufacturers or manufacturing process;


















·








warning letters;


















·








civil and criminal penalties;


















·








injunctions;


















·








suspension or withdrawal of regulatory approvals;


















·








product seizures, detentions or import bans;


















·








voluntary or mandatory product recalls and publicity requirements;


















·








total or partial suspension of production;


















·








imposition of restrictions on operations, including costly new manufacturing requirements; and


















·








refusal to approve pending BLAs or supplements to approved BLAs in the United States and refusal to approve marketing research approvals in other jurisdictions.






The FDA, the EMA and other non-U.S. regulatory authorities also have substantial discretion in the drug approval process. The number of preclinical studies and clinical studies that will be required for regulatory approval varies depending on the product candidate, the disease or condition that the product candidate is designed to address, and the regulations applicable to any particular drug candidate. Regulatory agencies can delay, limit or deny approval of a product candidate for many reasons, including:
















·








a product candidate may not be deemed safe or effective;

















3
































·








the results may not confirm the positive results from earlier preclinical studies or clinical studies;


















·








regulatory agencies may not find the data from preclinical studies and clinical studies sufficient or well-controlled;


















·








regulatory agencies might not approve or might require changes to our manufacturing processes or facilities; or


















·








regulatory agencies may change their approval policies or adopt new regulations.






For example, during the fourth quarter of 2018, the FDA concurred with our decision to place AFM11 on clinical hold after the occurrence of serious adverse events, or SAEs, in three patients, which included a death in our ALL study and two life-threatening events in our NHL study, and formally placed the AFM11 investigational new drug, or IND, application on full clinical hold.




Any delay in obtaining or failure to obtain required approvals could materially adversely affect our ability to generate revenue from the particular product candidate, which likely would result in significant harm to our financial position and adversely impact our share price. Furthermore, any regulatory approval to market a product may be subject to limitations on the indicated uses for which we may market the product. These limitations may limit the size of the market for the product.




Clinical drug development involves a lengthy and expensive process with uncertain timelines and uncertain outcomes, and results of earlier trials may not be predictive of future trial results. If clinical studies of our product candidates are prolonged or delayed, we may be unable to obtain required regulatory approvals, and therefore be unable to commercialize our product candidates on a timely basis or at all.




We have no history of conducting large-scale or pivotal clinical studies or commercializing pharmaceutical products, which may make it difficult to evaluate the prospects for our future viability.




Our operations to date have been limited to financing and staffing our company, developing our technology and developing AFM13, AFM11 and our other product candidates. We have not yet demonstrated an ability successfully to complete a large-scale or pivotal clinical study, obtain marketing approval, manufacture a commercial scale product or conduct sales and marketing activities necessary for successful product commercialization. Consequently, predictions about our future success or viability may not be as accurate as they could be if we had a history of successfully developing and commercializing pharmaceutical products.




If clinical studies for our product candidates are prolonged, delayed or stopped, we may be unable to obtain regulatory approval and commercialize our product candidates on a timely basis, which would require us to incur additional costs and delay or restrict our receipt of any product revenue.




There have been significant developments in the highly dynamic field of immuno-oncology such as the earlier availability of product candidates or earlier approval of drugs for the same indications as our product candidates. For example, in the past, this has occurred with Blincyto in acute lymphocytic leukemia, or ALL, and with anti-PD‑1 antibodies in Hodgkin Lymphoma, or HL, resulting in delays in clinical study initiation for our phase 1 trial of AFM11 in ALL and for delays in recruiting for our phase 1 trial of AFM11 in NHL and our phase 2a Investigator Sponsored Trial, or IST, of AFM13 in HL. In addition, certain clinical studies in which we are involved and which are testing our product candidates are sponsored by academic sites, known as ISTs. By definition, the financing, design, and conduct of such studies is under the sole responsibility of the respective sponsor. Therefore, we have limited control over these studies and we do not have control over the timing and reporting of the data from these trials. In addition, we may have limited information about ISTs while they are being conducted, including the status of trial initiation and patient recruitment, changes to trial design and clinical study results.















4




















A phase 2a clinical study of AFM13 in patients with HL started recruitment in the second quarter of 2015. Due to delays in opening trial sites and the availability of anti-PD‑1 antibodies for the treatment of relapsed/refractory HL patients, in the past we have experienced slower recruitment into the study than anticipated. Consequently, the overall study design was revised in order to adapt to the changing treatment landscape, namely the availability of anti-PD‑1 antibodies. The study now includes HL patients relapsed or refractory to treatment with both brentuximab vedotin (Adcetris®) and anti-PD‑1 antibodies. The study is open and recruiting under the new study design. Furthermore, we are conducting a phase 1b clinical study of AFM13 in combination with Merck’s anti-PD‑1 anti



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