Heidelberg, Germany, August 7, 2019 - Affimed N.V. (Nasdaq: AFMD), a clinical stage biopharmaceutical company committed to giving patients back their innate ability to fight cancer, today reported financial and operating results for the second quarter ended June 30, 2019.
“After reaching agreement with the U.S. Food and Drug Administration on the study protocol design, we are now in the process of preparing to initiate the AFM13 registration-directed Phase 2 study,” said Dr. Adi Hoess, Affimed’s CEO. “The recent positive final and interim results from two clinical studies of AFM13 add to the growing body of evidence supporting AFM13’s activity in CD30-positive lymphoma patients, and give us increased confidence in the potential of AFM13 to demonstrate clinical benefit in CD30-positive peripheral T cell lymphoma. To execute the Phase 2 study and to further advance our internal and partnered CD16A-targeting innate cell engager pipeline, we have significantly strengthened our organization through the addition of multiple key hires in the U.S. and Germany of individuals who have substantial drug development experience.”
Corporate Updates
Pipeline Updates
CD16A innate cell engager programs
AFM13 (CD30/CD16A)
AFM24 (EGFR/CD16A)
Technology Updates
Financial Highlights
(Figures for the second quarter and six months ended June 30, 2019 and 2018 are unaudited.)
Cash, cash equivalents and current financial assets totaled €87.7 million as of June 30, 2019, compared to €108.8 million as of December 31, 2018. Based on its current operating and budget assumptions, Affimed anticipates that its cash, cash equivalents and current financial assets as of June 30, 2019 will enable the Company to fund its planned clinical development and early development activities into 2021.
Net cash used in operating activities was €18.9 million for the six months ended June 30, 2019, compared to net cash used in operating activities of €15.2 million for the six months ended June 30, 2018. The increase is primarily due to higher cash expenditure for research and development efforts.
Total revenue was €4.0 million for the three months ended June 30, 2019 compared to €0.2 million for the three months ended June 30, 2018. The increase in revenue is attributable to the recognition of €3.7 million as revenue from the Genentech collaboration in the second quarter of 2019.
Research and development (R&D) expenses for the second quarter of 2019 were €11.5 million, including accrued termination costs of €1.4 million associated with the wind-down activities for the two Phase 1 studies of AFM11. R&D expenses for the second quarter of 2018 were €7.1 million. The increase was primarily related to higher expenses related to manufacturing activities for clinical study material for AFM13, startup activities for the AFM13 registration study in PTCL, early stage development and discovery activities, and the termination costs for the two AFM11 clinical studies.
General and administrative (G&A) expenses for the second quarter of 2019 were nearly unchanged at €2.3 million compared to €2.2 million for the second quarter of 2018.
Net loss was €10.3 million, or €0.17 per common share, for the second quarter of 2019, compared to a net loss of €8.0 million, or €0.13 per common share, for the second quarter 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 will host a conference call and webcast today, Wednesday, August 7, 2019 at 8:30 a.m. Eastern time to discuss the company’s financial results and recent corporate developments. To access the call, please dial +1 (917) 720-0178 for U.S. callers, or +44 (0) 203 0095710 for international callers, and reference conference ID 9396039 approximately 15 minutes prior to the call. An audio webcast of the conference call can be accessed in the “Webcasts” section on the “Investors” page of the Affimed website at https://www.affimed.com/investors/webcasts/. A replay of the webcast will be available on Affimed’s website shortly after the conclusion of the call and will be archived for 30 days following the call.
About Affimed N.V.
Affimed (Nasdaq: AFMD) is a clinical stage biopharmaceutical 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. 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 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, 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.
Affimed Investor Contact:
Gregory Gin, Head of Investor Relations
E-Mail: IR@affimed.com
Affimed Media Contact:
Anca Alexandru, Head of Communications, EU IR
E-Mail: media@affimed.com
Affimed N.V.
Unaudited consolidated statements of comprehensive income/(loss) (in € thousand)
For the three months ended June 30 | For the six months ended June 30 | ||||||||||||||||||||||||||||||||||||||||||||||||||||
2019 | 2018 | 2019 2018 | |||||||||||||||||||||||||||||||||||||||||||||||||||
Revenue | 4,008 | 150 | 15,361 | 682 | |||||||||||||||||||||||||||||||||||||||||||||||||
Other income – net | 197 | 49 | 283 | 38 | |||||||||||||||||||||||||||||||||||||||||||||||||
Research and development expenses | (11,545) | (7,149) | (19,532) | (13,545) | |||||||||||||||||||||||||||||||||||||||||||||||||
General and administrative expenses | (2,342) | (2,164) | (4,776) | (4,202) | |||||||||||||||||||||||||||||||||||||||||||||||||
Operating income / (loss) | (9,682) | (9,114) | (8,664) | (17,027) | |||||||||||||||||||||||||||||||||||||||||||||||||
Finance income / (costs) – net | (654) | 1,100 | 180 | 811 | |||||||||||||||||||||||||||||||||||||||||||||||||
Income / (loss) before tax | (10.336) | (8,014) | (8,484) | (16,216) | |||||||||||||||||||||||||||||||||||||||||||||||||
Income taxes | (4) | 0 | (4) | (1) | |||||||||||||||||||||||||||||||||||||||||||||||||
Income / (loss) for the period | (10,340) | (8,014) | (8,488) | (16,217) | |||||||||||||||||||||||||||||||||||||||||||||||||
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 | | (49) | 406 | 24 | 211 | ||||||||||||||||||||||||||||||||||||||||||||||||
Other comprehensive income / (loss) | (49) | 406 | 24 | 211 | |||||||||||||||||||||||||||||||||||||||||||||||||
Total comprehensive income / (loss) | (10,389) | (7,608) | (8,464) | (16,006) | |||||||||||||||||||||||||||||||||||||||||||||||||
Earnings / (loss) per share in € per share | (0.17) | (0.13) | (0.14) | (0.28) | |||||||||||||||||||||||||||||||||||||||||||||||||
(undiluted = diluted) | |||||||||||||||||||||||||||||||||||||||||||||||||||||
Weighted number of common shares outstanding | 62,439,363 | 62,390,068 62,434,734 | 58,614,053 | ||||||||||||||||||||||||||||||||||||||||||||||||||
Affimed N.V.
Consolidated statements of financial position (in € thousand)
June 30, 2019 | December 31, 2018 | |||
(unaudited) | ||||
ASSETS | ||||
Non-current assets | ||||
Intangible assets | 168 | 56 | ||
Leasehold improvements and equipment | 1,960 | 1,414 | ||
Long term financial assets | 3,849 | 3,825 | ||
Right-of-use assets | 653 | 0 | ||
6,630 | 5,295 | |||
Current assets | ||||
Cash and cash equivalents | 63,987 | 94,829 | ||
Financial assets | 23,726 | 13,974 | ||
Trade and other receivables | 1,471 | 1,429 | ||
Inventories | 330 | 260 | ||
Other assets | 2,973 | 387 | ||
92,487 | 110,879 | |||
TOTAL ASSETS | 99,117 | 116,174 | ||
EQUITY AND LIABILITIES | ||||
Equity | ||||
Issued capital | 624 | 624 | ||
Capital reserves | 240,235 | 239,055 | ||
Fair value reserves | 2,618 | 2,594 | ||
Accumulated deficit | (210,632) | (202,144) | ||
Total equity | 32,845 | 40,129 | ||
Non-current liabilities | ||||
Borrowings | 323 | 1,690 | ||
Contract liabilities | 39,138 | 37,512 | ||
Lease liabilities | 246 | 0 | ||
Total non-current liabilities | 39,707 | 39,202 | ||
Current liabilities | ||||
Trade and other payables | 7,541 | 9,425 | ||
Provisions | 1,440 | 0 | ||
Borrowings | 3,552 | 3,083 | ||
Lease liabilities | 377 | 0 | ||
Contract liabilities | 13,655 | 24,335 | ||
Total current liabilities | 26,565 | 36,843 | ||
TOTAL EQUITY AND LIABILITIES | 99,117 | 116,174 | ||
Affimed N.V.
Unaudited consolidated statements of cash flows (in € thousand)
For the six months ended June 30 | ||||||
2019 | 2018 | |||||
Cash flow from operating activities | ||||||
Income / (loss) for the period | (8,488) | (16,217) | ||||
Adjustments for the period: | ||||||
- Income taxes | 4 | 1 | ||||
- Depreciation and amortisation | 423 | 199 | ||||
- Net gain from disposal of leasehold improvements and equipment | (9) | 0 | ||||
- Share based payments | 1,167 | 937 | ||||
- Finance income / costs – net | (180) | (811) | ||||
(7,083) | (15,891) | |||||
Change in trade and other receivables | 228 | 88 | ||||
Change in inventories | (70) | (26) | ||||
Change in other assets | (2,586) | (1,159) | ||||
Change in trade, other payables, provisions and contract liabilities | (9,484) | 1,970 | ||||
Cash used in operating activities | (18,995) | (15,018) | ||||
Interest received | 188 | 58 | ||||
Paid interest | (134) | (196) | ||||
Net cash used in operating activities | (18,941) | (15,156) | ||||
Cash flow from investing activities | ||||||
Purchase of intangible assets | (142) | (26) | ||||
Purchase of leasehold improvements and equipment | (755) | (298) | ||||
Cash received from the sale of leasehold improvements and equipment | 0 | 1 | ||||
Cash paid for investments in financial assets | (35,262) | 0 | ||||
Cash received from maturity of financial assets | 25,748 | 0 | ||||
Net cash used for investing activities | (10,411) | (323) | ||||
Cash flow from financing activities | ||||||
Proceeds from issue of common shares | 13 | 25,042 | ||||
Transaction costs related to issue of common shares | 0 | (1,686) | ||||
Proceeds from borrowings | 562 | 0 | ||||
Repayment of lease liabilities | (206) | 0 | ||||
Repayment of borrowings | (1,649) | (1,500) | ||||
Cash flow from financing activities | (1,280) | 21,856 | ||||
Exchange-rate related changes of cash and cash equivalents | (210) | 1,198 | ||||
Net changes to cash and cash equivalents | (30,632) | 6,377 | ||||
Cash and cash equivalents at the beginning of the period | 94,829 | 39,837 | ||||
Cash and cash equivalents at the end of the period | 63,987 | 47,412 | ||||
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, 2018 | 468 | 213,778 | 7,325 | (182,667) | 38,904 | ||||
Issue of common shares | 156 | 23,190 | 23,346 | ||||||
Equity-settled share based payment awards | 937 | 937 | |||||||
Loss for the period | | (16,217) | (16,217) | ||||||
Other comprehensive income | 211 | 211 | |||||||
Balance as of June 30, 2018 | 624 | 237,905 | 7,536 | (198,884) | 47,181 | ||||
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 |