Full Press Release Details
Reports Financial Results for Fourth Quarter
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."
NK-cell engager programs
T-cell engager programs
Financial Highlights
(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 "Events" section on the "Investors & 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) 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.
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
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 347394 6793
E-Mail: IR@affimed.com or c.stewart@affimed.com
Anca Alexandru, Head of Communications, EU IR
Phone: +49 6221 64793341
E-Mail: a.alexandru@affimed.com
CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Consolidated statement of comprehensive
| 2014 | 2015 | 2016 | |||
| Revenue | 3,382 | 7,562 | 6,314 | ||
| Other income - net | 381 | 651 | 145 | ||
| Research and development expenses | (9,595) | (22,008) | (30,180) | ||
| General and administrative expenses | (2,346) | (7,548) | (8,323) | ||
| Operating loss | (8,178) | (21,343) | (32,044) | ||
| Finance income / (costs) - net | 7,753 | 1,104 | (230) | ||
| Loss before tax | (425) | (20,239) | (32,274) | ||
| Income taxes | 166 | 0 | 58 | ||
| Loss for the period | (259) | (20,239) | (32,216) | ||
| Total comprehensive loss | (259) | (20,239) | (32,216) | ||
| Loss per share in per share | (0.01) | (0.71) | (0.97) | ||
| (undiluted = diluted) |
Consolidated statement of financial position
| December 31, 2015 | December 31, 2016 | ||
| ASSETS | |||
| Non-current assets | |||
| Intangible assets | 72 | 55 | |
| Leasehold improvements and equipment | 915 | 822 | |
| 987 | 877 | ||
| Current assets | |||
| Inventories | 228 | 197 | |
| Trade and other receivables | 915 | 2,255 | |
| Other assets | 452 | 516 | |
| Financial assets | 0 | 9,487 | |
| Cash and cash equivalents | 76,740 | 35,407 | |
| 78,335 | 47,862 | ||
| TOTAL ASSETS | 79,322 | 48,739 | |
| EQUITY AND LIABILITIES | |||
| Equity | |||
| Issued capital | 333 | 333 | |
| Capital reserves | 187,169 | 190,862 | |
| Accumulated deficit | (120,228) | (152,444) | |
| Total equity | 67,274 | 38,751 | |
| Non current liabilities | |||
| Borrowings | 3,104 | 3,617 | |
| Total non-current liabilities | 3,104 | 3,617 | |
| Current liabilities | |||
| Trade and other payables | 4,444 | 5,323 | |
| Borrowings | 1,472 | 973 | |
| Deferred revenue | 3,028 | 75 | |
| Total current liabilities | 8,944 | 6,371 | |
| TOTAL EQUITY AND LIABILITIES | 79,322 | 48,739 |
Consolidated statement of cash flows (in
| 2014 | 2015 | 2016 | ||||
| Cash flow from operating activities | ||||||
| Loss for the period | (259) | (20,239) | (32,216) | |||
| Adjustments for the period: | ||||||
| - Income taxes | (166) | 0 | (58) | |||
| - Depreciation and amortisation | 441 | 336 | 369 | |||
| - Loss from disposal of leasehold improvements and equipment | 3 | 0 | 0 | |||
| - Share based payments | (4,891) | 2,220 | 3,545 | |||
| - Finance income / costs - net | (7,753) | (1,104) | 230 | |||
| (12,625) | (18,787) | (28,130) | ||||
| Change in trade and other receivables | 62 | 24 | (1,311) | |||
| Change in inventories | (59) | (29) | 31 | |||
| Change in other assets | 0 | (452) | (64) | |||
| Change in trade, other payables and deferred revenue | 2,275 | 1,253 | (2,177) | |||
| Cash used in operating activities | (10,347) | (17,991) | (31,651) | |||
| Interest received | 2 | 10 | 102 | |||
| Paid interest | (202) | (554) | (578) | |||
| Net cash used in operating activities | (10,547) | (18,535) | (32,127) | |||
| Cash flow from investing activities | ||||||
| Purchase of intangible assets | (45) | (28) | (21) | |||
| Purchase of leasehold improvements and equipment | (260) | (249) | (238) | |||
| Cash paid for investments in financial assets | 0 | 0 | (27,037) | |||
| Cash received from maturity of financial assets | 0 | 0 | 18,147 | |||
| Proceeds from sale of equipment | 7 | 0 | 0 | |||
| Net cash used for investing activities | (298) | (277) | (9,149) | |||
| Cash flow from financing activities | ||||||
| Proceeds from issue of common shares | 43,213 | 56,615 | 6 | |||
| Transactions costs related to issue of common shares | (5,343) | (3,117) | 0 | |||
| Proceeds from issue of preferred shares | 2,999 | 0 | 0 | |||
| Proceeds from borrowings | 4,020 | 0 | 5,000 | |||
| Transaction costs related to borrowings | 0 | 0 | (105) | |||
| Repayment of borrowings | 0 | 0 | (5,137) | |||
| Cash flow from financing activities | 44,889 | 53,498 | (236) | |||
| Net changes to cash and cash equivalents | 34,044 | 34,686 | (41,512) | |||
| Cash and cash equivalents at the beginning of the period | 4,151 | 39,725 | 76,740 | |||
| Exchange-rate related changes of cash and cash equivalents | 1,530 | 2,329 | 179 | |||
| Cash and cash equivalents at the end of the period | 39,725 | 76,740 | 35,407 |
Consolidated statement of changes in equity
| Issued capital | Capital reserves | Own shares | Accumulated deficit | Total equity | ||||||
| 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 | |||||
| Balance as of January 1, 2016 | 333 | 187,169 | 0 | (120,228) | 67,274 | |||||
| Issue of common shares 1 | 0 | 6 | 6 | |||||||
| Equity-settled share based payment awards | 3,545 | 3,545 | ||||||||
| Issue of warrant note (loan Silicon Valley Bank) | 142 | 142 | ||||||||
| Loss for the period | (32,216) | (32,216) | ||||||||
| Balance as of December 31, 2016 | 333 | 190,862 | 0 | (152,444) | 38,751 |
Issue of 3,341 shares
Consolidated statement of comprehensive
| Q4 2015 (unaudited) | Q4 2016 (unaudited) | |||
| Revenue | 1,659 | 1,371 | ||
| Other income - net | 20 | 2 | ||
| Research and development expenses | (7,034) | (5,724) | ||
| General and administrative expenses | (1,956) | (2,084) | ||
| Operating (loss) | (7,311) | (6,435) | ||
| Finance income / (costs) - net | 996 | 953 | ||
| Loss before tax | (6,315) | (5,482) | ||
| Income taxes | 36 | 60 | ||
| Loss for the period | (6,279) | (5,422) | ||
| Total comprehensive loss | (6,279) | (5,422) | ||
| Loss per share in per share | (0.19) | (0.16) | ||
| (undiluted = diluted) |
Consolidated statement of cash flows (in
| Q4 2015 (unaudited) | Q4 2016 (unaudited) | |||
| Cash flow from operating activities | ||||
| Loss for the period | (6,279) | (5,422) | ||
| Adjustments for the period: | ||||
| - Income taxes | (36) | (60) | ||
| - Depreciation and amortisation | 96 | 76 | ||
| - Share based payments | 767 | 826 | ||
| - Finance income / costs - net | (996) | (953) | ||
| (6,448) | (5,533) | |||
| Change in trade and other receivables | 532 | 87 | ||
| Change in inventories | 11 | 56 | ||
| Change in other assets | (452) | 87 | ||
| Change in trade, other payables and deferred revenue | 2,471 | (1,097) | ||
| Cash used in operating activities | (3,886) | (6,400) | ||
| Interest received | 5 | 42 | ||
| Paid interest | (128) | (223) | ||
| Net cash used in operating activities | (4,009) | (6,581) | ||
| Cash flow from investing activities | ||||
| Purchase of intangible assets | (18) | 0 | ||
| Purchase of leasehold improvements and equipment | (45) | (44) | ||
| Cash paid for investments in financial assets | 0 | 51 | ||
| Cash received from maturity of financial assets | 0 | 4,611 | ||
| Net cash used for investing activities | (63) | 4,618 | ||
| Cash flow from financing activities | ||||
| Proceeds from issue of common shares | 19,091 | 6 | ||
| Transactions costs related to issue of common shares | (27) | 0 | ||
| Proceeds from borrowings | 0 | 5,000 | ||
| Transaction costs related to borrowings | 0 | (105) | ||
| Repayment of borrowings | 0 | (4,058) | ||
| Cash flow from financing activities | 19,064 | 843 | ||
| Net changes to cash and cash equivalents | 14,992 | (1,120) | ||
| Cash and cash equivalents at the beginning of the period | 60,425 | 35,693 | ||
| Exchange-rate related changes of cash and cash equivalents | 1,323 | 834 | ||
| Cash and cash equivalents at the end of the period | 76,740 | 35,407 |