Heidelberg, 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, 2017.
"Our 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."
Corporate Updates
Pipeline Updates
NK-cell engager programs
T-cell engager programs
Financial Highlights
(Figures for the fourth quarter of 2017 and 2016 represent unaudited figures)
Cash and 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.
Net cash 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.
Revenue for 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.
R&D expenses 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.
G&A expenses 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.
Net loss 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 SEC.
Including 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.
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.
About Affimed N.V.
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.
Contact:
Anca Alexandru, Head of Communications, EU IR
Phone: +49 6221 64793341
E-Mail: a.alexandru@affimed.com, IR@affimed.com
AFFIMED N.V.
CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Affimed N.V.
Consolidated 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) |
Affimed N.V.
Consolidated 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 |
Affimed N.V.
Consolidated 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 |
Affimed N.V.
Consolidated 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 shares1 | 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 |
1 Issue of 3,341 shares
Affimed N.V.
Consolidated 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) |
Affimed N.V.
Consolidated 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 |