Earnings - March 30, 2017
Heidelberg, Germany, March 30, 2017 – Affimed N.V. (Nasdaq: AFMD), a clinical stage biopharmaceutical company focused on discovering and developing highly targeted cancer immunotherapies, today reported financial results for the quarter and year ended December 31, 2016.
“Throughout 2016, we expanded our leadership position in NK-cell engagement and made considerable progress both with our clinical and preclinical programs,” said Dr. Adi Hoess, CEO of Affimed. “We have successfully executed on our strategy to broaden our efforts in combination therapies, advancing our clinical trial for AFM13 with Merck’s Keytruda as well as initiating our collaboration with MD Anderson to combine our NK-cell engagers with MD Anderson’s adoptive NK-cell transfer.”
In January 2017, Affimed and The University of Texas MD Anderson Cancer Center (MDACC) announced an exclusive strategic clinical development and commercialization collaboration to evaluate Affimed’s tetravalent bispecific immune cell engager technology in combination with MDACC’s natural killer (NK-) cell product. The collaboration comprises research, development, and eventually commercialization of novel oncology therapeutics resulting from this combination of products. MDACC will be responsible for conducting preclinical research activities and these are intended to be followed by a Phase 1 clinical trial. Affimed will fund research and development expenses for this collaboration and the agreement includes a provision for the potential expansion of the partnership. Affimed holds an option to exclusive worldwide rights to develop and commercialize any product developed under the collaboration. Leveraging MDACC’s expertise in NK-cells and translational medicine, and Affimed’s capabilities to develop tumor-targeting bispecific tetravalent immune cell engagers, the combination is initially planned to investigate Affimed’s AFM13, a CD30/CD16A-targeting tetravalent bispecific antibody, with MDACC’s proprietary NK-cell product in HL. Harnessing the advantages of both antibody-based and cell therapy approaches, this combination has the potential to better exploit the therapeutic activity of NK-cells in HL and beyond, for example in other medically underserved indications such as multiple myeloma or acute myeloid leukemia.
NK cell engager programs
T cell engager programs
(Figures for the fourth quarter of 2016 and 2015 represent unaudited figures)
Cash and cash equivalents and financial assets totaled €44.9 million as of December 31, 2016 compared to €76.7 million as of December 31, 2015. The decrease was primarily attributable to Affimed’s operational expenses.
Net cash used in operating activities for the fourth quarter of 2016 was €6.6 million compared to €4.0 million for the fourth quarter of 2015. Net cash used in operating activities was €32.1 million for the twelve months ended December 31, 2016 compared to €18.5 million for the twelve months ended December 31, 2015. The year-over-year increase was primarily related to higher cash expenditure for research and development (R&D) in connection with our development and collaboration programs.
Revenue for the fourth quarter of 2016 was €1.4 million compared to €1.7 million for the fourth quarter of 2015. Revenue for the full year 2016 was €6.3 million compared to €7.6 million for the full year 2015. Revenue in both periods was primarily derived from Affimed’s collaborations with Amphivena and the LLS as well as from third party services rendered by AbCheck.
R&D expenses for the fourth quarter of 2016 were €5.7 million compared to €7.0 million for the fourth quarter of 2015. For the full year 2016, R&D expenses were €30.2 million compared to €22.0 million for the full year 2015. The increase was primarily related to higher expenses for AFM13, AFM11, preclinical programs and infrastructure.
G&A expenses for the fourth quarter of 2016 were €2.1 million compared to €2.0 million for the fourth quarter of 2015. For the full year 2016, G&A expenses were €8.3 million compared to €7.5 million for the full year 2015. The increase was primarily related to higher share-based payment expenses.
Net loss for the fourth quarter of 2016 was €5.4 million, or €0.16 per common share, compared to a net loss of €6.3 million, or €0.19 per common share, for the fourth quarter of 2015. Net loss for the full year 2016 was €32.2 million, or €0.97 per common share, compared to a loss of €20.2 million, or €0.71 per common share, for the full year 2015. The increase in net loss for the full year 2016 was primarily related to increased spending on R&D for AFM13, AFM11, preclinical programs and infrastructure. In addition, the result was affected by lower revenue and lower finance income. Additional information regarding these results is included in the notes to the consolidated financial statements as of December 31, 2016 and “Item 5. Operating and Financial Review and Prospects,” which will be included in Affimed’s Annual Report on Form 20-F as filed with the SEC.
Including the proceeds from the offering in January and February 2017, the Company’s operations, including clinical development and early development activities, are expected to be funded at least until the end of 2018.
Note on IFRS Reporting Standards
Affimed prepares and reports the consolidated financial statements and financial information in accordance with International Financial Reporting Standards (IFRS) as issued by the International Accounting Standards Board (IASB). None of the financial statements were prepared in accordance with Generally Accepted Accounting Principles (GAAP) in the United States. Affimed maintains its books and records in Euro.
Conference call and webcast information
Affimed’s management will host a conference call to discuss the company’s financial results and recent corporate developments today at 8:30 a.m. ET. A webcast of the conference call can be accessed in the Webcasts section on the Affimed website. A replay of the webcast will be available on Affimed’s website shortly after the conclusion of the call and will be archived on the Affimed website for 30 days following the call.
Affimed (Nasdaq: AFMD) engineers targeted immunotherapies, seeking to cure patients by harnessing the power of innate and adaptive immunity (NK and T cells). We are developing single and combination therapies to treat cancers and other life-threatening diseases. For more information, please visit www.affimed.com.
This press release contains forward-looking statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as "anticipate," "believe," "could," "estimate," "expect," "goal," "intend," "look forward to", "may," "plan," "potential," "predict," "project," "should," "will," "would" and similar expressions. Forwardlooking statements appear in a number of places throughout this release and include statements regarding our intentions, beliefs, projections, outlook, analyses and current expectations concerning, among other things, our ongoing and planned preclinical development and clinical trials, our collaborations and development of our products in combination with other therapies, the timing of and our ability to make regulatory filings and obtain and maintain regulatory approvals for our product candidates our intellectual property position, our collaboration activities, our ability to develop commercial functions, expectations regarding clinical trial data, our results of operations, cash needs, financial condition, liquidity, prospects, future transactions, growth and strategies, the industry in which we operate, the trends that may affect the industry or us and the risks uncertainties and other factors described under the heading “Risk Factors” in Affimed’s filings with the Securities and Exchange Commission. Given these risks, uncertainties and other factors, you should not place undue reliance on these forward-looking statements, and we assume no obligation to update these forward-looking statements, even if new information becomes available in the future.
Caroline Stewart, Head IR
Phone: +1 347 394 6793
Anca Alexandru, Head of Communications, EU IR
Phone: +49 6221 64793341