Full Press Release Details
Reports Financial Results for Fourth Quarter
Germany, March 20, 2018 - 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,
approach of harnessing the power of innate and adaptive immunity showed its first clinical potential in 2017 and early 2018 with
very encouraging data becoming available for AFM13 as monotherapy in Hodgkin and CD30-positve lymphomas as well as for AFM13 in
combination with Keytruda in Hodgkin lymphoma," said Dr. Adi Hoess, CEO of Affimed. "In addition, we were able to
hire outstanding executive managers with Leila Alland as CMO and Wolfgang Fischer as COO, who will be instrumental to the further
development of our pipeline towards marketed therapies."
NK-cell engager programs
T-cell engager programs
the utility of AMV564 in solid tumors. AMV564 is a CD33/CD3-specific T cell engagers based on Affimed's technology
platform. Affimed owns approximately 18.5% of Amphivena (fully diluted).
for the fourth quarter of 2017 and 2016 represent unaudited figures)
cash equivalents and financial assets totaled 39.8 million as of December 31, 2017 compared to 44.9 million as of
December 31, 2016. Affimed was able to fund its operational expenses in 2017 with existing cash, the issuance of new shares and
the usage of an additional loan tranche.
used in operating activities for the fourth quarter of 2017 was 4.9 million compared to 6.6 million for the fourth
quarter of 2016. Net cash used in operating activities was 25.5 million for the twelve months ended December 31, 2017 compared
to 32.1 million for the twelve months ended December 31, 2016. The year-over-year decrease was primarily related to lower
cash expenditure for research and development (R&D) in connection with our development and collaboration programs.
the fourth quarter of 2017 was 0.6 million compared to 1.4 million for the fourth quarter of 2016. Revenue for the
full year 2017 was 2.0 million compared to 6.3 million for the full year 2016. Revenue for the full year and the fourth
quarter 2017 was primarily derived from AbCheck services. Revenue for the full year 2016 related to a large extent to Affimed's
collaborations with Amphivena and LLS while revenue for the fourth quarter 2016 was derived from AbCheck services.
for the fourth quarter of 2017 were 4.6 million compared to 5.7 million for the fourth quarter of 2016. For the full
year 2017, R&D expenses were 21.5 million compared to 30.2 million for the full year 2016. The decrease was primarily
related to lower expenses for AFM13 related CMC activities, preclinical programs and infrastructure.
for the fourth quarter of 2017 were 1.9 million compared to 2.1 million for the fourth quarter of 2016. For the full
year 2017, G&A expenses were slightly lower with 8.0 million compared to 8.3 million for the full year 2016.
for the fourth quarter of 2017 was 6.4 million, or 0.14 per common share, compared to a net loss of 5.4 million,
or 0.19 per common share, for the fourth quarter of 2016. Net loss for the full year 2017 was 30.2 million, or 0.69
per common share, compared to a net loss of 32.2 million, or 0.97 per common share, for the full year 2016. The decrease
in net loss for the full year 2017 was primarily related to decreased spending on R&D for AFM13 related CMC
activities, preclinical
programs and infrastructure, partially offset by lower revenue and higher finance costs. Additional information regarding these
results is included in the notes to the consolidated financial statements as of December 31, 2017 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 proceeds from the equity offering in February 2018, the Company's operations, including clinical development and early
development activities, are expected to be funded at least until the fourth quarter of 2019.
IFRS Reporting Standards
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
Call and Webcast Information
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
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.
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.
Anca Alexandru, Head of Communications,
Phone: +49 6221 64793341
E-Mail: a.alexandru@affimed.com,
CONSOLIDATED FINANCIAL STATEMENTS
statements of comprehensive loss (in thousand)
| 2015 | 2016 | 2017 | ||||||||||
| Revenue | 7,562 | 6,314 | 2,010 | |||||||||
| Other income - net | 651 | 145 | 205 | |||||||||
| Research and development expenses | (22,008 | ) | (30,180 | ) | (21,489 | ) | ||||||
| General and administrative expenses | (7,548 | ) | (8,323 | ) | (7,986 | ) | ||||||
| Operating loss | (21,343 | ) | (32,044 | ) | (27,260 | ) | ||||||
| Finance income / (costs) - net | 1,104 | (230 | ) | (2,983 | ) | |||||||
| Loss before tax | (20,239 | ) | (32,274 | ) | (30,243 | ) | ||||||
| Income taxes | 0 | 58 | 20 | |||||||||
| Loss for the period | (20,239 | ) | (32,216 | ) | (30,223 | ) | ||||||
| Total comprehensive loss | (20,239 | ) | (32,216 | ) | (30,223 | ) | ||||||
| Loss per share in per share (undiluted = diluted) | (0.71 | ) | (0.97 | ) | (0.69 | ) |
statements of financial position (in thousand)
| December 31, 2016 | December 31, 2017 | |||||||
| ASSETS | ||||||||
| Non-current assets | ||||||||
| Intangible assets | 55 | 65 | ||||||
| Leasehold improvements and equipment | 822 | 1,113 | ||||||
| 877 | 1,178 | |||||||
| Current assets | ||||||||
| Inventories | 197 | 241 | ||||||
| Trade and other receivables | 2,255 | 1,102 | ||||||
| Other assets | 516 | 800 | ||||||
| Financial assets | 9,487 | 0 | ||||||
| Cash and cash equivalents | 35,407 | 39,837 | ||||||
| 47,862 | 41,980 | |||||||
| TOTAL ASSETS | 48,739 | 43,158 | ||||||
| EQUITY AND LIABILITIES | ||||||||
| Equity | ||||||||
| Issued capital | 333 | 468 | ||||||
| Capital reserves | 190,862 | 213,778 | ||||||
| Accumulated deficit | (152,444 | ) | (182,667 | ) | ||||
| Total equity | 38,751 | 31,579 | ||||||
| Non-current liabilities | ||||||||
| Borrowings | 3,617 | 4,086 | ||||||
| Total non-current liabilities | 3,617 | 4,086 | ||||||
| Current liabilities | ||||||||
| Trade and other payables | 5,323 | 4,180 | ||||||
| Borrowings | 973 | 3,083 | ||||||
| Deferred revenue | 75 | 230 | ||||||
| Total current liabilities | 6,371 | 7,493 | ||||||
| TOTAL EQUITY AND LIABILITIES | 48,739 | 43,158 |
statements of cash flows (in thousand)
| 2015 | 2016 | 2017 | ||||||||||
| Cash flow from operating activities | ||||||||||||
| Loss for the period | (20,239 | ) | (32,216 | ) | (30,223 | ) | ||||||
| Adjustments for the period: | ||||||||||||
| - Income taxes | 0 | (58 | ) | (20 | ) | |||||||
| - Depreciation and amortization | 336 | 369 | 351 | |||||||||
| - Net gain from disposal of leasehold improvements and equipment | 0 | 0 | (19 | ) | ||||||||
| - Share based payments | 2,220 | 3,545 | 1,943 | |||||||||
| - Finance income / costs - net | (1,104 | ) | 230 | 2,983 | ||||||||
| (18,787 | ) | (28,130 | ) | (24,985 | ) | |||||||
| Change in trade and other receivables | 24 | (1,311 | ) | 1,140 | ||||||||
| Change in inventories | (29 | ) | 31 | (44 | ) | |||||||
| Change in other assets | (452 | ) | (64 | ) | (399 | ) | ||||||
| Change in trade, other payables and deferred revenue | 1,253 | (2,177 | ) | (1,018 | ) | |||||||
| Cash used in operating activities | (17,991 | ) | (31,651 | ) | (25,306 | ) | ||||||
| Interest received | 10 | 102 | 106 | |||||||||
| Paid interest | (554 | ) | (578 | ) | (349 | ) | ||||||
| Net cash used in operating activities | (18,535 | ) | (32,127 | ) | (25,549 | ) | ||||||
| Cash flow from investing activities | ||||||||||||
| Purchase of intangible assets | (28 | ) | (21 | ) | (43 | ) | ||||||
| Purchase of leasehold improvements and equipment | (249 | ) | (238 | ) | (625 | ) | ||||||
| Cash received from the sale of leasehold improvements and equipment | 0 | 0 | 35 | |||||||||
| Cash paid for investments in convertible note and warrants | 0 | 0 | (296 | ) | ||||||||
| Cash paid for investments in financial assets | 0 | (27,037 | ) | (13,084 | ) | |||||||
| Cash received from maturity of financial assets | 0 | 18,147 | 22,063 | |||||||||
| Net cash used for investing activities | (277 | ) | (9,149 | ) | 8,050 | |||||||
| Cash flow from financing activities | ||||||||||||
| Proceeds from issue of common shares | 56,615 | 6 | 23,123 | |||||||||
| Transaction costs related to issue of common shares | (3,117 | ) | 0 | (1,648 | ) | |||||||
| Proceeds from borrowings | 0 | 5,000 | 2,500 | |||||||||
| Transaction costs related to borrowings | 0 | (105 | ) | (11 | ) | |||||||
| Repayment of borrowings | 0 | (5,137 | ) | (167 | ) | |||||||
| Cash flow from financing activities | 53,498 | (236 | ) | 23,797 | ||||||||
| Exchange-rate related changes of cash and cash equivalents | 2,329 | 179 | (1,867 | ) | ||||||||
| Net changes to cash and cash equivalents | 34,686 | (41,512 | ) | 6,297 | ||||||||
| Cash and cash equivalents at the beginning of the period | 39,725 | 76,740 | 35,407 | |||||||||
| Cash and cash equivalents at the end of the period | 76,740 | 35,407 | 39,837 |
statements of changes in equity (in thousand)
| Issued capital | Capital reserves | Accumulated deficit | Total equity | |||||||||||||
| Balance as of January 1, 2015 | 240 | 131,544 | (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 award | 2,220 | 2,220 | ||||||||||||||
| Loss for period | (20,239 | ) | (20,239 | ) | ||||||||||||
| Balance as of December 31, 2015 | 333 | 187,169 | (120,228 | ) | 67,274 | |||||||||||
| Balance as of January 1, 2016 | 333 | 187,169 | (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 | (152,444 | ) | 38,751 | |||||||||||
| Balance as of January 1, 2017 | 333 | 190,862 | (152,444 | ) | 38,751 | |||||||||||
| Issue of common shares | 135 | 20,922 | 21,057 | |||||||||||||
| Equity-settled share based payment awards | 1,943 | 1,943 | ||||||||||||||
| Issue of warrant note (loan Silicon Valley Bank) | 51 | 51 | ||||||||||||||
| Loss for the period | (30,223 | ) | (30,223 | ) | ||||||||||||
| Balance as of December 31, 2017 | 468 | 213,778 | (182,667 | ) | 31,579 |
statements of comprehensive loss (in thousand)
| Q4 2016 (unaudited) | Q4 2017 (unaudited) | |||||||
| Revenue | 1,371 | 636 | ||||||
| Other income - net | 2 | 4 | ||||||
| Research and development expenses | (5,724 | ) | (4,608 | ) | ||||
| General and administrative expenses | (2,084 | ) | (1,895 | ) | ||||
| Operating (loss) | (6,435 | ) | (5,863 | ) | ||||
| Finance income / (costs) - net | 953 | (558 | ) | |||||
| Loss before tax | (5,482 | ) | (6,421 | ) | ||||
| Income taxes | 60 | 0 | ||||||
| Loss for the period | (5,422 | ) | (6,421 | ) | ||||
| Total comprehensive loss | (5,422 | ) | (6,421 | ) | ||||
| Loss per share in per share | (0.19 | ) | (0.14 | ) | ||||
| (undiluted = diluted) |
statements of cash flows (in thousand)
| Q4 2016 (unaudited) | Q4 2017 (unaudited) | |||||||
| Cash flow from operating activities | ||||||||
| Loss for the period | (5,422 | ) | (6,421 | ) | ||||
| Adjustments for the period: | ||||||||
| - Income taxes | (60 | ) | 0 | |||||
| - Depreciation and amortization | 76 | 94 | ||||||
| - Share based payments | 826 | 449 | ||||||
| - Finance income / costs - net | (953 | ) | 558 | |||||
| (5,533 | ) | (5,320 | ) | |||||
| Change in trade and other receivables | 87 | 450 | ||||||
| Change in inventories | 56 | 41 | ||||||
| Change in other assets | 87 | (6 | ) | |||||
| Change in trade, other payables and deferred revenue | (1,097 | ) | 26 | |||||
| Cash used in operating activities | (6,400 | ) | (4,809 | ) | ||||
| Interest received | 42 | 58 | ||||||
| Paid interest | (223 | ) | (120 | ) | ||||
| Net cash used in operating activities | (6,581 | ) | (4,871 | ) | ||||
| Cash flow from investing activities | ||||||||
| Purchase of intangible assets | 0 | (17 | ) | |||||
| Purchase of leasehold improvements and equipment | (44 | ) | (80 | ) | ||||
| Cash paid for investments in convertible note and warrants | 0 | (296 | ) | |||||
| Cash paid for investments in financial assets | 51 | 30 | ||||||
| Cash received from maturity of financial assets | 4,611 | 8,638 | ||||||
| Net cash used for investing activities | 4,618 | 8,275 | ||||||
| Cash flow from financing activities | ||||||||
| Proceeds from issue of common shares | 6 | 3,882 | ||||||
| Transaction costs related to issue of common shares | 0 | (124 | ) | |||||
| Proceeds from borrowings | 5,000 | 0 | ||||||
| Transaction costs related to borrowings | (105 | ) | 0 | |||||
| Repayment of borrowings | (4,058 | ) | (167 | ) | ||||
| Cash flow from financing activities | 843 | 3,591 | ||||||
| Exchange-rate related changes of cash and cash equivalents | 834 | (501 | ) | |||||
| Net changes to cash and cash equivalents | (1,120 | ) | 6,995 | |||||
| Cash and cash equivalents at the beginning of the period | 35,693 | 33,343 | ||||||
| Cash and cash equivalents at the end of the period | 35,407 | 39,837 |