Full Press Release Details
Affimed Reports Financial Results for
--Successful Financings Closed and
US Presence Established--
Heidelberg, Germany, March 30, 2016 -
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 fourth quarter and year ended December 31, 2015.
"2015 was a formative year for Affimed,"
said Dr. Adi Hoess, CEO of Affimed. "Through the continuous support of our investors we were able to broaden the development
of our NK- and T-cell-recruiting immunotherapies. We have continued to successfully advance our clinical and preclinical pipeline
and, in particular, we have made significant headway with our lead candidate AFM13 toward development as both mono- and combination
Corporate Highlights
infiltration by T-cells as well
as substantially elevated levels of cytokines within the tumor, indicating AFM13's unique ability to trigger the body's
natural immune cascade.
Preclinical programs
Financial Highlights
(Figures for the fourth quarter of 2015
and 2014 represent unaudited figures)
Cash and cash equivalents totaled 76.7
million as of December 31, 2015 compared to 39.7 million as of December 31, 2014. The increase was primarily attributable
to the completion of Affimed's follow-on offering of its common shares on May 12, 2015, and the sale of additional shares
to Aeris Capital on October 9, 2015.
Net cash used in operating activities for
the fourth quarter of 2015 was 4.0 million compared to 5.4 million for the fourth quarter of 2014. Net cash used in
operating activities was 18.5 million for the twelve months ended December 31, 2015 compared to 10.5 million for the
twelve months ended December 31, 2014. 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 and to higher general and administrative
Revenue for the fourth quarter of 2015 was
1.7 million compared to 0.1 million for the fourth quarter of 2014 due to revenue earned under the Amphivena collaboration
in the 2015 period. Revenue for the full year 2015 was 7.6 million compared to 3.4 million for the full year 2014.
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 2015 were 7.0 million compared to 4.1 million for the fourth quarter of 2014. For the full year 2015, R&D expenses
were 22.0 million compared to 9.6 million for the full year 2014. The increase was primarily related to higher expenses
for AFM13, other preclinical programs and infrastructure.
G&A expenses for the fourth quarter
of 2015 were 2.0 million compared to 1.7 million for the fourth quarter of 2014. For the full year 2015, G&A expenses
were 7.5 million compared to 2.3 million for the full year 2014. The increase was primarily related to a credit to
the share-based payment expense resulting from a re-measurement gain at consummation of the IPO in 2014.
Net loss for the fourth quarter of 2015
was 6.3 million, or 0.19 per common share, compared to a net loss of 5.3 million, or 0.22 per common share,
for the fourth quarter of 2014. Net loss for the full year 2015 was 20.2 million, or 0.71 per common share, compared
to a loss of 0.3 million, or 0.01 per common share, for the full year 2014. The increase in net loss for the full year
2015 is primarily related to non-operational and non-cash effects in 2014 upon the corporate reorganization at the time of the
IPO in September 2014 as well as to increased spending on infrastructure and on research and development commensurate with the
ramp-up of the clinical trials for our lead product candidate AFM13 and for our preclinical programs in 2015. Additional information
regarding these results is included in the notes to the consolidated financial statements as of December 31, 2015 and "Item
5. Operating and Financial Review and Prospects," which will be included in Affimed's Annual Report on Form 20-F as
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. EST. A webcast of the
conference call can be accessed in the "Events" section on the "Media" page of the Affimed website at http://www.affimed.com/events.php.
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) is a clinical-stage
biopharmaceutical company focused on discovering and developing highly targeted cancer immunotherapies. Affimed's product
candidates are being developed in the field of immuno-oncology, which represents an innovative approach to cancer treatment that
seeks to harness the body's own immune defenses to fight tumor cells. The most potent cells of the human defense arsenal
are types of white blood cells called natural killer cells, or NK-cells, and T-cells. Affimed's proprietary, next-generation
bispecific antibodies, called TandAbs for their tandem antibody structure, are designed to direct and establish a bridge between
either NK-cells or T-cells and cancer cells, triggering a signal cascade that leads to the destruction of cancer cells. Affimed
has focused its research and development efforts on three proprietary TandAb programs for which it retains global commercial rights.
For more information, please visit www.affimed.com.
FORWARD-LOOKING STATEMENTS
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. Forward-looking statements
are based on management's beliefs and assumptions and on information available to management only as of the date of this press
release. These forward-looking statements include, but are not limited to, statements regarding the risk of cessation or delay
of any of the ongoing or planned clinical studies and/or development of our product candidates. Our actual results could differ
materially from those anticipated in these forward-looking statements for many reasons, including, without limitation, risks associated
with our clinical development activities, regulatory oversight, product commercialization, collaborations, intellectual property
claims, 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 347394 6793
E-Mail: IR@affimed.com or c.stewart@affimed.com
Anca Alexandru, Head of Communications
Phone: +49 6221 64793341
E-Mail: a.alexandru@affimed.com
CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Consolidated statement of comprehensive
| 2013 | 2014 | 2015 | ||||||||||
| Revenue | 5,087 | 3,382 | 7,562 | |||||||||
| Other income - net | 610 | 381 | 651 | |||||||||
| Research and development expenses | (14,354 | ) | (9,595 | ) | (22,008 | ) | ||||||
| General and administrative expenses | (7,046 | ) | (2,346 | ) | (7,548 | ) | ||||||
| Operating (loss) | (15,703 | ) | (8,178 | ) | (21,343 | ) | ||||||
| Finance income / (costs) - net | (10,397 | ) | 7,753 | 1,104 | ||||||||
| Loss before tax | (26,100 | ) | (425 | ) | (20,239 | ) | ||||||
| Income taxes | 1 | 166 | 0 | |||||||||
| Loss for the period | (26,099 | ) | (259 | ) | (20,239 | ) | ||||||
| Comprehensive loss | (26,099 | ) | (259 | ) | (20,239 | ) | ||||||
| Loss per share in per share | (1.76 | ) | (0.01 | ) | (0.71 | ) | ||||||
| (undiluted = diluted) |
Consolidated statement of financial position
| December 31, 2014 | December 31, 2015 | |||||||
| ASSETS | ||||||||
| Non-current assets | ||||||||
| Intangible assets | 72 | 72 | ||||||
| Leasehold improvements and equipment | 974 | 915 | ||||||
| 1,046 | 987 | |||||||
| Current assets | ||||||||
| Inventories | 199 | 228 | ||||||
| Trade and other receivables | 939 | 915 | ||||||
| Other assets | 0 | 452 | ||||||
| Cash and cash equivalents | 39,725 | 76,740 | ||||||
| 40,863 | 78,335 | |||||||
| TOTAL ASSETS | 41,909 | 79,322 | ||||||
| EQUITY AND LIABILITIES | ||||||||
| Equity | ||||||||
| Issued capital | 240 | 333 | ||||||
| Capital reserves | 131,544 | 187,169 | ||||||
| Accumulated deficit | (99,989 | ) | (120,228 | ) | ||||
| Total equity | 31,795 | 67,274 | ||||||
| Non current liabilities | ||||||||
| Borrowings | 3,895 | 3,104 | ||||||
| Total non-current liabilities | 3,895 | 3,104 | ||||||
| Current liabilities | ||||||||
| Trade and other payables | 3,759 | 4,444 | ||||||
| Borrowings | 0 | 1,472 | ||||||
| Deferred revenue | 2,460 | 3,028 | ||||||
| Total current liabilities | 6,219 | 8,944 | ||||||
| TOTAL EQUITY AND LIABILITIES | 41,909 | 79,322 |
Consolidated statement of cash flows (in
| 2013 | 2014 | 2015 | ||||||||||
| Cash flow from operating activities | ||||||||||||
| Loss for the period | (26,099 | ) | (259 | ) | (20,239 | ) | ||||||
| Adjustments for the period: | ||||||||||||
| - Income taxes | (1 | ) | (166 | ) | 0 | |||||||
| - Depreciation and amortization | 427 | 441 | 336 | |||||||||
| - Loss from disposal of leasehold improvements and equipment | 24 | 3 | 0 | |||||||||
| - Share based payments | 8,054 | (4,891 | ) | 2,220 | ||||||||
| - Finance income / costs - net | 10,397 | (7,753 | ) | (1,104 | ) | |||||||
| (7,198 | ) | (12,625 | ) | (18,787 | ) | |||||||
| Change in trade and other receivables | (333 | ) | 62 | 24 | ||||||||
| Change in inventories | (20 | ) | (59 | ) | (29 | ) | ||||||
| Change in other assets | 0 | 0 | (452 | ) | ||||||||
| Change in trade and other payables | 1,880 | 2,275 | 1,253 | |||||||||
| Cash used in operating activities | (5,671 | ) | (10,347 | ) | (17,991 | ) | ||||||
| Interest received | 9 | 2 | 10 | |||||||||
| Paid interest | (16 | ) | (202 | ) | (554 | ) | ||||||
| Net cash used in operating activities | (5,678 | ) | (10,547 | ) | (18,535 | ) | ||||||
| Cash flow from investing activities | ||||||||||||
| Purchase of intangible assets | (23 | ) | (45 | ) | (28 | ) | ||||||
| Purchase of leasehold improvements and equipment | (139 | ) | (260 | ) | (249 | ) | ||||||
| Proceeds from sale of equipment | 5 | 7 | 0 | |||||||||
| Net cash used for investing activities | (157 | ) | (298 | ) | (277 | ) | ||||||
| Cash flow from financing activities | ||||||||||||
| Proceeds from issue of common shares | 0 | 43,213 | 56,615 | |||||||||
| Transactions costs related to issue of common shares | 0 | (5,343 | ) | (3,117 | ) | |||||||
| Proceeds from issue of preferred shares | 0 | 2,999 | 0 | |||||||||
| Proceeds from convertible debt | 5,100 | 0 | 0 | |||||||||
| Transactions costs related to preferred shares and convertible debt | (16 | ) | 0 | 0 | ||||||||
| Proceeds from borrowings | 0 | 4,020 | 0 | |||||||||
| Cash flow from financing activities | 5,084 | 44,889 | 53,498 | |||||||||
| Net changes to cash and cash equivalents | (751 | ) | 34,044 | 34,686 | ||||||||
| Cash and cash equivalents at the beginning of the period | 4,902 | 4,151 | 39,725 | |||||||||
| Exchange-rate related changes of cash and cash equivalents | 0 | 1,530 | 2,329 | |||||||||
| Cash and cash equivalents at the end of the period | 4,151 | 39,725 | 76,740 |
Consolidated statement of changes in equity
| Issued capital | Capital reserves | Own shares | Accumulated deficit | Total equity | ||||||||||||||||
| Balance as of January 1, 2013 | 63 | 469 | (25 | ) | (73,631 | ) | (73,124 | ) | ||||||||||||
| Loss for the period | (26,099 | ) | (26,099 | ) | ||||||||||||||||
| Balance as of December 31, 2013 | 63 | 469 | (25 | ) | (99,730 | ) | (99,223 | ) | ||||||||||||
| Balance as of January 1, 2014 | 63 | 469 | (25 | ) | (99,730 | ) | (99,223 | ) | ||||||||||||
| Exchange of preferred shares | 97 | 84,907 | 25 | 85,029 | ||||||||||||||||
| Issue of common shares | 80 | 37,791 | 37,871 | |||||||||||||||||
| Modification of cash-settled share based payment awards | 7,648 | 7,648 | ||||||||||||||||||
| Equity-settled share based payment awards | 299 | 299 | ||||||||||||||||||
| Issue of warrant note (Perceptive loan) | 430 | 430 | ||||||||||||||||||
| Loss for the period | (259 | ) | (259 | ) | ||||||||||||||||
| Balance as of December 31, 2014 | 240 | 131,544 | 0 | (99,989 | ) | 31,795 | ||||||||||||||
| Balance as of January 1, 2015 | 240 | 131,544 | 0 | (99,989 | ) | 31,795 | ||||||||||||||
| Issue of common shares | 91 | 52,463 | 52,554 | |||||||||||||||||
| Exercise of share based payment awards | 2 | 942 | 944 | |||||||||||||||||
| Equity-settled share based payment awards | 2,220 | 2,220 | ||||||||||||||||||
| Loss for the period | (20,239 | ) | (20,239 | ) | ||||||||||||||||
| Balance as of December 31, 2015 | 333 | 187,169 | 0 | (120,228 | ) | 67,274 |
Consolidated statement of comprehensive