Full Press Release Details
Affimed Reports 2020 Financial Results and
Highlights Recent Operational Progress
Heidelberg, Germany, April 15, 2021 Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving
patients back their innate ability to fight cancer, today reported financial results for the year ended December 31, 2020 and provided an update on clinical and corporate progress.
2020 was an important year for Affimed. We continued to build on the strong foundation of our scientific discoveries and made significant progress
across all our programs. We broadened our clinical pipeline, added new collaborations, built a strong balance sheet, appointed key senior management executives and ensured that our programs stayed on track through the global pandemic, said
Dr. Adi Hoess, CEO of Affimed. We entered 2021 with strong momentum, and the recently announced positive outcome of our interim futility analysis for our registration directed study of AFM13 as monotherapy in PTCL patients, and initial
data from the trial investigating AFM13 pre-complexed natural killer cells in Hodgkin lymphoma patients provide further validation for our three-pronged development strategy. As we look ahead into 2021, we
anticipate numerous additional updates as we advance our programs.
Clinical Stage Program Updates
Three-pronged Development Strategy
Based on preclinical
and clinical data, Affimed is pursuing development of its innate cell engagers (ICE ) as monotherapy, and in combination with adoptive NK cell transfer and PD-1/PD-L1 checkpoint inhibitors.
Preclinical and Partnered Programs
Other Corporate Updates
Full Year 2020 Financial Highlights
As of December 31, 2020, cash, cash equivalents and current financial assets totaled 146.9 million compared to 104.1 million on
December 31, 2019. The pro forma cash position as of December 31, 2020, including net proceeds from the January 2021 underwritten public offering and the first tranche of the Silicon Valley Bank loan, would be approximately
Based on its current operating plan and assumptions, Affimed anticipates that its cash and cash equivalents
will support operations into the second half of 2023.
Net cash used in operating activities for the year ended December 31, 2020 amounted to
19.4 million compared to 29.1 million for the year ended December 31, 2019. The amount received in 2020 includes an initial upfront payment and committed funding of 33.3 million (US$ 40 million) from the Roivant
Total revenue for the year ended December 31, 2020 was 28.4 million compared with 21.4 million for the year
ended December 31, 2019. Revenue for 2020 and 2019 predominantly relate to the Genentech collaboration. Collaboration revenue for the year ended December 31, 2020 amounted to 27.8 million, with 26.2 million from the
Genentech collaboration and 1.4 million from the Roivant collaboration. Collaboration revenue of 19.7 million for the year ended December 31, 2019 was from the Genentech collaboration.
Research and development expenses for 2020 increased 14.2% from 43.8 million in the year ended December 31, 2019 to 50.0 million in
the year ended December 31, 2020, due to higher expenses for AFM24 and our other projects and infrastructure investments.
General and administrative
expenses increased 33.6% from 10.3 million in the year ended December 31, 2019 to 13.7 million in the year ended December 31, 2020. In 2020, general and administrative expenses were largely comprised of personnel
expenses of 6.3 million and legal, consulting and audit costs of 5.6 million.
Finance costs for the year ended December 31,
2020 were 6.6 million, compared to finance income of 15 thousand for the year ended December 31, 2019. Finance costs for the year ended December 31, 2020 were largely comprised of foreign exchange losses related to
assets denominated in U.S. dollars as a result of the weakening of the U.S. dollar compared to the Euro during the year.
Net loss for the year ended
December 31, 2020 was 41.4 million, or 0.50 per common share compared with a net loss of 32.4 million, or 0.50 per common share, for the year ended December 31, 2019.
The weighted number of common shares outstanding for the year ended December 31, 2020 was 83.5 million.
Additional information regarding these results is included in the notes to the consolidated financial statements as of December 31, 2020 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 U.S. Securities and Exchange Commission (SEC).
Note on International Financial Reporting Standards (IFRS)
Affimed prepares and reports consolidated financial statements and financial information in accordance with IFRS as issued by the International Accounting
Standards Board. None of the financial statements were prepared in accordance with Generally Accepted Accounting Principles in the United States. Affimed maintains its books and records in Euro.
Conference Call and Webcast Information
Affimed will host a conference call and webcast today, April 15, 2021 at 8:30 a.m. EDT to discuss fourth quarter 2020 financial results and recent
corporate developments. The conference call will be available via phone and webcast.
To access the call, please dial +1 (646) 741-3167 for U.S. callers, or +44 (0) 2071 928338 for international callers, and reference passcode 4271307 approximately 15 minutes prior to the call.
A live audio webcast of the conference call will be available in the Webcasts section on the Investors page of the Affimed website at
https://www.affimed.com/investors/webcasts_cp/. A replay of the webcast will be accessible at the same link for 30 days following the call.
Affimed (Nasdaq: AFMD) is a
clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer by actualizing the untapped potential of the innate immune system. The company s proprietary ROCK platform enables a tumor-targeted approach to recognize and kill a range of hematologic and solid tumors, enabling a broad pipeline of wholly-owned and partnered single agent and combination
therapy programs. The ROCK platform predictably generates customized innate cell engager (ICE ) molecules, which use patients
immune cells to destroy tumor cells. This innovative approach enabled Affimed to become the first company with a clinical-stage ICE . Headquartered in Heidelberg, Germany, with offices in New
York, NY, Affimed is led by an experienced team of biotechnology and pharmaceutical leaders united by a bold vision to stop cancer from ever derailing patients lives. For more about the company s people, pipeline and partners, 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, the potential of AFM13, AFM24, and our other product candidates, the value of our ROCK platform, 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, 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, impacts of the
COVID-19 pandemic, the benefits to Affimed of orphan drug designation and the risks, uncertainties and other factors described under the heading Risk Factors in Affimed s filings with the SEC.
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
Investor Relations Contact
Director, Head of Investor Relations
E-Mail: a.fudukidis@affimed.com
Tel.: +1 (917) 436-8102
Consolidated statements of comprehensive income / (loss) (in thousand)
| 2020 | 2019 | 2018 | ||||||||||
| Revenue | 28,360 | 21,391 | 23,735 | |||||||||
| Other income - net | 626 | 290 | 1,515 | |||||||||
| Research and development expenses | (49,989 | ) | (43,791 | ) | (35,148 | ) | ||||||
| General and administrative expenses | (13,715 | ) | (10,266 | ) | (9,638 | ) | ||||||
| Operating loss | (34,718 | ) | (32,376 | ) | (19,536 | ) | ||||||
| Finance income / (costs) - net | (6,647 | ) | 15 | 60 | ||||||||
| Loss before tax | (41,365 | ) | (32,361 | ) | (19,476 | ) | ||||||
| Income taxes | (1 | ) | (4 | ) | (1 | ) | ||||||
| Loss for the period | (41,366 | ) | (32,365 | ) | (19,477 | ) | ||||||
| Other comprehensive income / (loss) | ||||||||||||
| Items that will not be reclassified to profit or loss Equity investments at fair value OCI - net change in | ||||||||||||
| fair value | (242 | ) | (632 | ) | (4,731 | ) | ||||||
| Other comprehensive income / (loss) | (242 | ) | (632 | ) | (4,731 | ) | ||||||
| Total comprehensive Loss | (41,608 | ) | (32,997 | ) | (24,208 | ) | ||||||
| Earnings / (loss) per share in per share (undiluted = diluted) | (0.50 | ) | (0.50 | ) | (0.32 | ) | ||||||
| Weighted number of common shares outstanding | 83,471,559 | 64,242,396 | 60,514,407 |
Consolidated statements of financial position (in thousand)
| December 31, 2020 | December 31, 2019 | |||||||
| ASSETS | ||||||||
| Non-current assets | ||||||||
| Intangible assets | 1,718 | 137 | ||||||
| Leasehold improvements and equipment | 2,226 | 2,291 | ||||||
| Long term financial assets | 20,042 | 3,193 | ||||||
| Right-of-use assets | 940 | 824 | ||||||
| 24,926 | 6,445 | |||||||
| Current assets | ||||||||
| Cash and cash equivalents | 146,854 | 95,234 | ||||||
| Financial assets | 0 | 8,902 | ||||||
| Trade and other receivables | 2,439 | 1,482 | ||||||
| Inventories | 246 | 296 | ||||||
| Other assets | 1,260 | 0 | ||||||
| 150,799 | 105,914 | |||||||
| TOTAL ASSETS | 175,725 | 112,359 | ||||||
| EQUITY AND LIABILITIES | ||||||||
| Equity | ||||||||
| Issued capital | 983 | 762 | ||||||
| Capital reserves | 345,164 | 270,451 | ||||||
| Fair value reserves | 1,720 | 1,962 | ||||||
| Accumulated deficit | (275,874 | ) | (234,508 | ) | ||||
| Total equity | 71,993 | 38,667 | ||||||
| Non-current liabilities | ||||||||
| Borrowings | 231 | 278 | ||||||
| Contract liabilities | 35,992 | 37,961 | ||||||
| Lease liabilities | 482 | 272 | ||||||
| Total non-current liabilities | 36,705 | 38,511 | ||||||
| Current liabilities | ||||||||
| Trade and other payables | 11,394 | 10,674 | ||||||
| Provisions | 0 | 517 | ||||||
| Borrowings | 92 | 2,105 | ||||||
| Lease liabilities | 492 | 532 | ||||||
| Contract liabilities | 55,049 | 21,353 | ||||||
| Total current liabilities | 67,027 | 35,181 | ||||||
| TOTAL EQUITY AND LIABILITIES | 175,725 | 112,359 |
Consolidated statements of cash flows (in thousand)
| 2020 | 2019 | 2018 | ||||||||||
| Cash flow from operating activities | ||||||||||||
| Income / (loss) for the period | (41,366 | ) | (32,365 | ) | (19,477 | ) | ||||||
| Adjustments for the period: | ||||||||||||
| - Income taxes | 1 | 4 | 1 | |||||||||
| - Depreciation and amortisation | 1,115 | 906 | 403 | |||||||||
| - Net gain / loss from disposal of leasehold improvements and equipment | 34 | (5 | ) | 25 | ||||||||
| - Share based payments | 3,381 | 2,469 | 2,035 | |||||||||
| - Finance income / costs net | 6,647 | (15 | ) | (60 | ) | |||||||
| (30,188) | (29,006) | (17,073) | ||||||||||
| Change in trade and other receivables | (1,065 | ) | 33 | (322 | ) | |||||||
| Change in inventories | 50 | (36 | ) | (19 | ) | |||||||
| Change in other assets | (1,260 | ) | 340 | 121 | ||||||||
| Change in trade, other payables, provisions and contract liabilities | 12,848 | (791 | ) | 66,856 | ||||||||
| Cash used in operating activities | (19,615 | ) | (29,460 | ) | 49,563 | |||||||
| Interest received | 294 | 628 | 218 | |||||||||
| Paid interest | (78 | ) | (224 | ) | (342 | ) | ||||||
| Paid income tax | (1 | ) | 0 | (1 | ) | |||||||
| Net cash used in operating activities | (19,400 | ) | (29,056 | ) | 49,438 | |||||||
| Cash flow from investing activities | ||||||||||||
| Purchase of intangible assets | (9 | ) | (150 | ) | (30 | ) | ||||||
| Purchase of leasehold improvements and equipment | (431 | ) | (1,324 | ) | (691 | ) | ||||||
| Cash received from the sale of leasehold improvements and equipment | 0 | 0 | 1 | |||||||||
| Cash paid for investments in financial assets | (8,101 | ) | (45,131 | ) | (14,029 | ) | ||||||
| Cash received from maturity of financial assets | 16,547 | 50,945 | 0 | |||||||||
| Cash paid for investments in long term financial assets | 0 | 0 | (861 | ) | ||||||||
| Net cash used for investing activities | 8,006 | 4,340 | (15,610 | ) | ||||||||
| Cash flow from financing activities | ||||||||||||
| Proceeds from issue of common shares | 74,195 | 31,373 | 25,113 | |||||||||
| Transaction costs related to issue of common shares | (2,294 | ) | (2,215 | ) | (1,701 | ) | ||||||
| Proceeds from borrowings | 0 | 562 | 0 | |||||||||
| Repayment of lease liabilities | (521 | ) | (405 | ) | 0 | |||||||
| Repayment of borrowings | (2,128 | ) | (3,277 | ) | (2,917 | ) | ||||||
| Cash flow from financing activities | 69,252 | 26,038 | 20,495 | |||||||||
| Exchange-rate related changes of cash and cash equivalents | (6,238 | ) | (917 | ) | 669 | |||||||
| Net changes to cash and cash equivalents | 57,858 | 1,322 | 54,323 | |||||||||
| Cash and cash equivalents at the beginning of the period | 95,234 | 94,829 | 39,837 | |||||||||
| Cash and cash equivalents at the end of the period | 146,854 | 95,234 | 94,829 |
Consolidated statements of changes in equity (in thousand)
| Issued capital | Capital reserves | Fair value reserves | Accumulated deficit | Total equity | ||||||||||||||||
| Balance as of January 1, 2018 | 468 | 213,778 | 7,325 | (182,667 | ) | 38,904 | ||||||||||||||
| Issue of common shares | 156 | 23,171 | 23,327 | |||||||||||||||||
| Exercise of share based payment awards | 71 | 71 | ||||||||||||||||||
| Equity-settled share based payment awards | 2,035 | 2,035 | ||||||||||||||||||
| Loss for the period | (19,477 | ) | (19,477 | ) | ||||||||||||||||
| Other comprehensive income | (4,731 | ) | (4,731 | ) | ||||||||||||||||
| Balance as of December 31, 2018 | 624 | 239,055 | 2,594 | (202,144 | ) | 40,129 | ||||||||||||||
| Balance as of January 1, 2019 | 624 | 239,055 | 2,594 | (202,144 | ) | 40,129 | ||||||||||||||
| Issue of common shares | 138 | 28,901 | 29,039 | |||||||||||||||||
| Exercise of share based payment awards | 26 | 26 | ||||||||||||||||||
| Equity-settled share based payment awards | 2,469 | 2,469 | ||||||||||||||||||
| Loss for the period | (32,365 | ) | (32,365 | ) | ||||||||||||||||
| Other comprehensive income | (632 | ) | (632 | ) | ||||||||||||||||
| Balance as of December 31, 2019 | 762 | 270,451 | 1,962 | (234,508 | ) | 38,667 | ||||||||||||||
| Balance as of January 1, 2020 | 762 | 270,451 | 1,962 | (234,508 | ) | 38,667 | ||||||||||||||
| Issue of common shares | 205 | 68,341 | 68,546 | |||||||||||||||||
| Exercise of share based payment awards | 16 | 2,991 | 3,007 | |||||||||||||||||
| Equity-settled share based payment awards | 3,381 | 3,381 | ||||||||||||||||||
| Loss for the period | (41,366 | ) | (41,366 | ) | ||||||||||||||||
| Other comprehensive income | (242 | ) | (242 | ) | ||||||||||||||||
| Balance as of December 31, 2020 | 983 | 345,164 | 1,720 | (275,874 | ) | 71,993 |