Heidelberg, Germany, August 11, 2020 – 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 second quarter 2020 and provided an update on clinical and corporate progress.
“Affimed’s first half performance demonstrates the strength of the new management team and our ability to stay focused on executing our business strategy despite the continuing challenge of the COVID-19 environment. Always with the patient in mind, we are committed to advancing our pipeline as well as continuing to deepen our research to unlock the full potential of the innate immune system to fight cancer,” said Dr. Adi Hoess, CEO of Affimed. “We have multiple Innate Cell Engager (ICE®) programs in clinical development, both partnered and wholly-owned, which are the basis for providing a cadence of a continuous data output in 2020 and 2021.”
Development Program Updates
AFM13 (CD30/CD16A)
AFM24 (EGFR/CD16A)
Genentech Collaboration Update
Preclinical Pipeline Update
Management Appointments
Additions to the Supervisory Board
Second Quarter 2020 Financial Highlights
(Figures for the second quarter ended June 30, 2020 and 2019 are unaudited.)
As of June 30, 2020, cash, cash equivalents and current financial assets totaled €92.6 million compared to €104.1 million on December 31, 2019. During the quarter, the company received net proceeds of approximately €20.8 million under its at-the-market (“ATM”) program.
Based on its current operating plan and assumptions, Affimed anticipates that its cash, cash equivalents and current financial assets will support operations into the first half of 2022.
Net cash used in operating activities for the quarter ended June 30, 2020 was €15.0 million compared to €5.6 million in the second quarter of 2019. The second quarter 2019 net cash used in operating activities included a milestone payment to the company from the Genentech collaboration.
Total revenue for the second quarter of 2020 was €2.9 million compared with €4.0 million in the second quarter of 2019. Revenue in 2020 and 2019 predominantly relate to the Genentech collaboration (2020: €2.7 million, 2019: €3.7 million). Revenue from the Genentech collaboration in the second quarter 2020 was comprised of revenue recognized for collaborative research services performed during the quarter.
R&D expenses for the second quarter of 2020 were €11.7 million compared to €11.5 million in the second quarter of 2019. Expenses in 2020 relate predominantly to our AFM13 and AFM24 clinical programs as well as to our early stage development and discovery activities.
G&A expenses for the second quarter of 2020 were €2.6 million compared to €2.3 million in the second quarter of 2019. The increase is primarily related to higher Sarbanes-Oxley compliance costs, as well as an increase in legal, consulting and audit costs.
Net loss for the second quarter of 2020 was €12.2 million or €0.16 per common share. For the second quarter of 2019, the company’s net loss was €10.3 million or €0.17 per common share.
Weighted number of common shares outstanding for the quarter ended June 30, 2020 were 79.2 million.
Affimed encourages shareholders to also review its 6-K filing for the quarter ended June 30, 2020, as filed with the United States Securities and Exchange Commission.
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, Tuesday, August 11, 2020 at 8:30 a.m. EDT to discuss second 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 8855368 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.
About Affimed N.V.
Affimed (Nasdaq: AFMD) is a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer. Affimed’s fit-for-purpose ROCK® platform allows innate cell engagers to be designed for specific patient populations. The company is developing single and combination therapies to treat hematologic and solid tumors. The company is currently enrolling patients into a registration-directed study of AFM13 for CD30-positive relapsed/refractory peripheral T cell lymphoma and into a Phase 1/2a dose escalation/expansion study of AFM24 for the treatment of advanced EGFR-expressing solid tumors. 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, the potential of AFM24, 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 future.
Investor & Media Contact:
Alex Fudukidis
Head of Investor Relations
E-Mail: a.fudukidis@affimed.com
Tel.: (917) 436-8102
Affimed N.V.
Unaudited consolidated statements of comprehensive income / (loss) (in € thousand)
For the three months | For the six months | |||||
ended June 30 | ended June 30 | |||||
2020 | 2019 | 2020 | 2019 | |||
Revenue | 2,934 | 4,008 | 8,069 | 15,361 | ||
Other income – net | 85 | 197 | 28 | 283 | ||
Research and development expenses | (11,697) | (11,545) | (23,146) | (19,532) | ||
General and administrative expenses | (2,606) | (2,342) | (6,131) | (4,776) | ||
Operating income / (loss) | (11,284) | (9,682) | (21,180) | (8,664) | ||
Finance income / (costs) – net | (954) | (654) | 653 | 180 | ||
Income / (loss) before tax | (12,238) | (10,336) | (20,527) | (8,484) | ||
Income taxes | 0 | (4) | 0 | (4) | ||
Income / (loss) for the period | (12,238) | (10,340) | (20,527) | (8,488) | ||
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 | | (71) | (49) | 10 | 24 | |
Other comprehensive income / (loss) | (71) | (49) | 10 | 24 | ||
Total comprehensive income / (loss) | (12,309) | (10,389) | (20,517) | (8,464) | ||
Earnings / (loss) per share in € per share | (0.16) | (0.17) | (0.26) | (0.14) | ||
(undiluted = diluted) | ||||||
Weighted number of common shares outstanding | 79,189,686 | 62,439,363 | 77,719,793 | 62,434,734 |
Affimed N.V.
Consolidated statements of financial position (in € thousand)
June 30, 2020 | December 31, 2019 | |||
(unaudited) | ||||
ASSETS | ||||
Non-current assets | ||||
Intangible assets | 103 | 137 | ||
Leasehold improvements and equipment | 2,237 | 2,291 | ||
Long term financial assets | 3,203 | 3,193 | ||
Right-of-use assets | 536 | 824 | ||
6,079 | 6,445 | |||
Current assets | ||||
Cash and cash equivalents | 84,584 | 95,234 | ||
Financial assets | 8,037 | 8,902 | ||
Trade and other receivables | 2,027 | 1,482 | ||
Inventories | 421 | 296 | ||
95,069 | 105,914 | |||
TOTAL ASSETS | 101,148 | 112,359 | ||
EQUITY AND LIABILITIES | ||||
Equity | ||||
Issued capital | 845 | 762 | ||
Capital reserves | 292,720 | 270,451 | ||
Fair value reserves | 1,972 | 1,962 | ||
Accumulated deficit | (255,035) | (234,508) | ||
Total equity | 40,502 | 38,667 | ||
Non-current liabilities | ||||
Borrowings | 231 | 278 | ||
Contract liabilities | 27,829 | 37,961 | ||
Lease liabilities | 95 | 272 | ||
Total non-current liabilities | 28,155 | 38,511 | ||
Current liabilities | ||||
Trade and other payables | 6,606 | 10,674 | ||
Provisions | 484 | 517 | ||
Borrowings | 1,039 | 2,105 | ||
Lease liabilities | 451 | 532 | ||
Contract liabilities | 23,911 | 21,353 | ||
Total current liabilities | 32,491 | 35,181 | ||
TOTAL EQUITY AND LIABILITIES | 101,148 | 112,359 |
Affimed N.V.
Unaudited consolidated statements of cash flows (in € thousand)
For the six months ended June 30, | |||||
2020 | 2019 | ||||
Cash flow from operating activities | |||||
Income / (loss) for the period | (20,527) | (8,488) | |||
Adjustments for the period: | |||||
- Income taxes | 0 | 4 | |||
- Depreciation and amortisation | 551 | 423 | |||
- Net gain from disposal of leasehold improvements and equipment | 0 | (9) | |||
- Share based payments | 1,410 | 1,167 | |||
- Finance income / costs – net | (653) | (180) | |||
(19,219) | (7,083) | ||||
Change in trade and other receivables | (649) | 228 | |||
Change in inventories | (125) | (70) | |||
Change in other assets | 0 | (2,586) | |||
Change in trade, other payables, provisions and contract liabilities | (11,757) | (9,484) | |||
Cash used in operating activities | (31,750) | (18,995) | |||
Interest received | 276 | 188 | |||
Paid interest | (64) | (134) | |||
Net cash used in operating activities | (31,538) | (18,941) | |||
Cash flow from investing activities | |||||
Purchase of intangible assets | (2) | (142) | |||
Purchase of leasehold improvements and equipment | (174) | (755) | |||
Cash paid for investments in financial assets | (8,101) | (35,262) | |||
Cash received from maturity of financial assets | 9,088 | 25,748 | |||
Net cash used for investing activities | 811 | (10,411) | |||
Cash flow from financing activities | |||||
Proceeds from issue of common shares | 21,785 | 13 | |||
Transaction costs related to issue of common shares | (754) | 0 | |||
Proceeds from borrowings | 0 | 562 | |||
Repayment of lease liabilities | (257) | (206) | |||
Repayment of borrowings | (1,128) | (1,649) | |||
Cash flow from financing activities | 19,646 | (1,280) | |||
Exchange-rate related changes of cash and cash equivalents | 431 | (210) | |||
Net changes to cash and cash equivalents | (11,081) | (30,632) | |||
Cash and cash equivalents at the beginning of the period | 95,234 | 94,829 | |||
Cash and cash equivalents at the end of the period | 84,584 | 63,987 |
Affimed N.V.
Unaudited consolidated statements of changes in equity (in € thousand)
Issued capital | Capital reserves | Fair Value reserves | Accumulated deficit | Total equity | |||||
Balance as of January 1, 2019 | 624 | 239,055 | 2,594 | (202,144) | 40,129 | ||||
Exercise of share based payment awards | | 13 | 13 | ||||||
Equity-settled share based payment awards | 1,167 | 1,167 | |||||||
Loss for the period | (8,488) | (8,488) | |||||||
Other comprehensive income | 24 | 24 | |||||||
Balance as of June 30, 2019 | 624 | 240,235 | 2,618 | (210,632) | 32,845 | ||||
Balance as of January 1, 2020 | 762 | 270,451 | 1,962 | (234,508) | 38,667 | ||||
Issue of common shares | 83 | 20,859 | 20,942 | ||||||
Equity-settled share based payment awards | 1,410 | 1,410 | |||||||
Loss for the period | (20,527) | (20,527) | |||||||
Other comprehensive income | 10 | 10 | |||||||
Balance as of June 30, 2020 | 845 | 292,720 | 1,972 | (255,035) | 40,502 |