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Unaudited interim consolidated
statements of comprehensive income / (loss) (in thousand)
| For the three months ended September 30, | For the nine months ended September 30, | |||||||||||||||||||
| Note | 2021 | 2020 | 2021 | 2020 | ||||||||||||||||
| Revenue | 3 | 8,662 | 10,545 | 30,028 | 18,614 | |||||||||||||||
| Other income/(expenses) - net | 231 | 102 | 710 | 130 | ||||||||||||||||
| Research and development expenses | (20,621 | ) | (10,101 | ) | (53,826 | ) | (33,247 | ) | ||||||||||||
| General and administrative expenses | (6,841 | ) | (3,455 | ) | (16,766 | ) | (9,586 | ) | ||||||||||||
| Operating income / (loss) | (18,569 | ) | (2,909 | ) | (39,854 | ) | (24,089 | ) | ||||||||||||
| Finance income / (costs) - net | 4 | 1,474 | (3,057 | ) | 5,421 | (2,404 | ) | |||||||||||||
| Loss before tax | (17,095 | ) | (5,966 | ) | (34,433 | ) | (26,493 | ) | ||||||||||||
| Income taxes | (2 | ) | ||||||||||||||||||
| Loss for the period | (17,095 | ) | (5,966 | ) | (34,435 | ) | (26,493 | ) | ||||||||||||
| 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 | 5 | (3,489 | ) | (139 | ) | (8,838 | ) | (129 | ) | |||||||||||
| Other comprehensive income / (loss) | (3,489 | ) | (139 | ) | (8,838 | ) | (129 | ) | ||||||||||||
| Total comprehensive loss | (20,584 | ) | (6,105 | ) | (43,273 | ) | (26,622 | ) | ||||||||||||
| Loss per share in per share (undiluted = diluted) | (0.14 | ) | (0.07 | ) | (0.29 | ) | (0.33 | ) | ||||||||||||
| Weighted number of common shares outstanding | 119,786,695 | 86,030,878 | 118,545,453 | 80,490,155 |
The Notes are an integral part of these
condensed interim consolidated financial statements.
Interim consolidated statements of financial position (in thousand)
| Note | September 30, 2021 | December 31, 2020 | ||||||||||
| (unaudited) | ||||||||||||
| ASSETS | ||||||||||||
| Non-current assets | ||||||||||||
| Intangible assets | 1,634 | 1,718 | ||||||||||
| Leasehold improvements and equipment | 3,332 | 2,226 | ||||||||||
| Long term financial assets | 5 | 11,204 | 20,042 | |||||||||
| Right-of-use assets | 894 | 940 | ||||||||||
| 17,064 | 24,926 | |||||||||||
| Current assets | ||||||||||||
| Cash and cash equivalents | 198,742 | 146,854 | ||||||||||
| Trade and other receivables | 6 | 3,759 | 2,439 | |||||||||
| Inventories | 692 | 246 | ||||||||||
| Other assets | 7 | 78 | 1,260 | |||||||||
| 203,271 | 150,799 | |||||||||||
| TOTAL ASSETS | 220,335 | 175,725 | ||||||||||
| EQUITY AND LIABILITIES | ||||||||||||
| Equity | ||||||||||||
| Issued capital | 1,198 | 983 | ||||||||||
| Capital reserves | 450,086 | 345,164 | ||||||||||
| Fair value reserves | (7,118 | ) | 1,720 | |||||||||
| Accumulated deficit | (310,309 | ) | (275,874 | ) | ||||||||
| Total equity | 8 | 133,857 | 71,993 | |||||||||
| Non-current liabilities | ||||||||||||
| Borrowings | 10 | 10,073 | 231 | |||||||||
| Contract liabilities | 3 | 9,800 | 35,992 | |||||||||
| Lease liabilities | 314 | 482 | ||||||||||
| Total non-current liabilities | 20,187 | 36,705 | ||||||||||
| Current liabilities | ||||||||||||
| Trade and other payables | 13,716 | 11,394 | ||||||||||
| Borrowings | 10 | 94 | 92 | |||||||||
| Lease liabilities | 666 | 492 | ||||||||||
| Contract liabilities | 3 | 51,815 | 55,049 | |||||||||
| Total current liabilities | 66,291 | 67,027 | ||||||||||
| TOTAL EQUITY AND LIABILITIES | 220,335 | 175,725 |
The Notes are an integral part of these
condensed consolidated interim financial statements.
Unaudited interim consolidated statements of cash flows (in thousand)
| For the nine months ended September 30, | ||||||||||||
| Note | 2021 | 2020 | ||||||||||
| Cash flow from operating activities | ||||||||||||
| Loss for the period | (34,435 | ) | (26,493 | ) | ||||||||
| Adjustments for the period: | ||||||||||||
| - Income taxes | 2 | |||||||||||
| - Depreciation and amortisation | 935 | 821 | ||||||||||
| - Net gain / loss from disposal of leasehold improvements and equipment | (2 | ) | ||||||||||
| - Share based payments | 9 | 8,117 | 2,348 | |||||||||
| - Finance income / costs - net | 4 | (5,421 | ) | 2,404 | ||||||||
| (30,804 | ) | (20,920 | ) | |||||||||
| Change in trade and other receivables | (1,320 | ) | (1,174 | ) | ||||||||
| Change in inventories | (446 | ) | (114 | ) | ||||||||
| Change in other assets | 1,064 | (1,087 | ) | |||||||||
| Change in trade, other payables, provisions and contract liabilities | (26,802 | ) | (12,053 | ) | ||||||||
| Cash used in operating activities | (58,308 | ) | (35,348 | ) | ||||||||
| Interest received | 299 | |||||||||||
| Paid interest | (647 | ) | (81 | ) | ||||||||
| Paid income tax | (2 | ) | ||||||||||
| Net cash used in operating activities | (58,957 | ) | (35,130 | ) | ||||||||
| Cash flow from investing activities | ||||||||||||
| Purchase of intangible assets | (5 | ) | (8 | ) | ||||||||
| Purchase of leasehold improvements and equipment | (1,527 | ) | (352 | ) | ||||||||
| Cash paid for investments in financial assets | (8,101 | ) | ||||||||||
| Cash received from maturity of financial assets | 9,088 | |||||||||||
| Net cash used for investing activities | (1,532 | ) | 627 | |||||||||
| Cash flow from financing activities | ||||||||||||
| Proceeds from issue of common shares, including exercise of share based payment awards | 8 | 103,379 | 33,846 | |||||||||
| Transaction costs related to issue of common shares | 8 | (6,548 | ) | (1,134 | ) | |||||||
| Proceeds from borrowings | 10 | 10,000 | ||||||||||
| Transaction costs related to borrowings | (236 | ) | ||||||||||
| Repayment of lease liabilities | (372 | ) | (386 | ) | ||||||||
| Repayment of borrowings | (69 | ) | (1,151 | ) | ||||||||
| Cash flow from financing activities | 106,154 | 31,175 | ||||||||||
| Exchange-rate related changes of cash and cash equivalents | 6,223 | (2,250 | ) | |||||||||
| Net changes to cash and cash equivalents | 45,665 | (3,328 | ) | |||||||||
| Cash and cash equivalents at the beginning of the period | 146,854 | 95,234 | ||||||||||
| Cash and cash equivalents at the end of the period | 198,742 | 89,656 |
The Notes are an integral part of these
condensed interim consolidated financial statements.
Unaudited interim consolidated statements of changes in equity (in thousand)
| Note | Issued capital | Capital reserves | Fair value reserves | Accumulated deficit | Total equity | |||||||||||||||||||
| Balance as of January 1, 2020 | 762 | 270,451 | 1,962 | (234,508 | ) | 38,667 | ||||||||||||||||||
| Issue of common shares | 121 | 32,502 | 32,623 | |||||||||||||||||||||
| Equity-settled share based payment awards | 9 | 2,348 | 2,348 | |||||||||||||||||||||
| Loss for the period | (26,493 | ) | (26,493 | ) | ||||||||||||||||||||
| Other comprehensive income | (129 | ) | (129 | ) | ||||||||||||||||||||
| Balance as of September 30, 2020 | 883 | 305,301 | 1,833 | (261,001 | ) | 47,016 | ||||||||||||||||||
| Balance as of January 1, 2021 | 983 | 345,164 | 1,720 | (275,874 | ) | 71,993 | ||||||||||||||||||
| Issue of common shares | 8 | 205 | 94,138 | 94,343 | ||||||||||||||||||||
| Exercise of share based payment awards | 10 | 2,667 | 2,677 | |||||||||||||||||||||
| Equity-settled share based payment awards | 9 | 8,117 | 8,117 | |||||||||||||||||||||
| Loss for the period | (34,435 | ) | (34,435 | ) | ||||||||||||||||||||
| Other comprehensive loss | (8,838 | ) | (8,838 | ) | ||||||||||||||||||||
| Balance as of September 30, 2021 | 1,198 | 450,086 | (7,118 | ) | (310,309 | ) | 133,857 |
The Notes are an integral part of these
condensed consolidated interim financial statements.
Affimed N.V. is a Dutch company with limited liability (naamloze vennootschap) and has its corporate seat in Amsterdam, the Netherlands.
The condensed interim consolidated financial statements are comprised of Affimed N.V., and its controlled (and wholly owned) subsidiaries Affimed GmbH,
Heidelberg, Germany, AbCheck s.r.o., Plzen, Czech Republic and Affimed Inc., Delaware, USA (collectively Affimed , the Company or the Group ).
Affimed is a clinical-stage biopharmaceutical company focused on discovering and developing highly targeted cancer immunotherapies. The Group s
product candidates are developed in the field of immuno-oncology, which represents an innovative approach to cancer treatment that seeks to harness the body s own immune defenses to fight tumor cells. Affimed has its own research and
development programs, strategic collaborations and service contracts, where the Group is performing research services for third parties.
preparation and changes to Group s accounting policies
Statement of compliance
The condensed interim consolidated financial statements (referred to as interim financial statements ) for the three and nine months ended
September 30, 2021 and 2020 have been prepared in accordance with IAS 34 Interim Financial Reporting. The interim financial statements do not include all the information and disclosures required in the consolidated annual financial statements,
and should be read in conjunction with Affimed N.V. s annual consolidated financial statements as of December 31, 2020.
The interim financial
statements were authorized for issuance by the management board on November 10, 2021.
Critical judgments and accounting estimates
The preparation of the interim financial statements in conformity with IFRS requires management to make judgments, estimates and assumptions that affect the
application of accounting policies and the reported amounts of assets, liabilities, income and expenses. Actual results may differ from these estimates. Estimates and underlying assumptions are reviewed on an ongoing basis. Revisions to accounting
estimates are recognized in the period in which the estimates are revised and in any future periods affected.
In preparing these interim financial
statements, the critical judgments made by management in applying the Company s accounting policies were the same as those that applied to the consolidated financial statements as of and for the year ended December 31, 2020.
Functional and presentation currency
These interim financial statements are presented in Euro. The functional currency of the Group s subsidiaries is also the Euro. All
financial information presented in Euro has been rounded to the nearest thousand (abbreviated ) or million (abbreviated million).
Significant accounting policies
The accounting policies
applied by the Group in these interim financial statements are the same as those applied by the Group in its consolidated financial statements as of and for the year ended December 31, 2020.
New standards and interpretations
standards and amendments to standards have not been applied in preparing these consolidated financial statements.
| Standard/interpretation | Effective Date | |
| Amendments to IFRS 3 Business Combinations | January 1, 2022 | |
| Amendments to IAS 16 Property, Plant and Equipment | January 1, 2022 | |
| Amendments to IAS 37 Provisions, Contingent Liabilities and Contingent Assets | January 1, 2022 | |
| Annual Improvements 2018-2020 | January 1, 2022 | |
| Amendments to IAS 1 Presentation of Financial Statements: | ||
| Classification of Liabilities as Current or Non-current | January 1, 2023 | |
| Amendments to IAS 1 Presentation of Financial Statements and IFRS Practice Statement 2: Disclosure of Accounting policies | January 1, 2023 | |
| Amendments to IAS 8 Accounting policies, Changes in Accounting Estimates and Errors: Definition of Accounting Estimates | January 1, 2023 | |
| Amendments to IAS 12 Income Taxes: Deferred Tax related to Assets and Liabilities arising from a Single Transaction | January 1, 2023 |
The amended standards are not expected to have a significant effect on the consolidated financial statements of the Group.
Fair Value Measurement
All assets and liabilities for
which fair value is recognized in the interim financial statements are classified in accordance with the following fair value hierarchy, based on the lowest level input parameter that is significant on the whole for fair value
The carrying amount of all trade and other receivables, other assets, certificates of deposit,
cash and cash equivalents and trade and other payables is a reasonable approximation of the fair value and, therefore, information about the fair values of those financial instruments has not been disclosed. The measurement of the fair value of the
shares held by the group and note disclosure for the fair value of a loan (financial liability) is based on level 3 and 2 measurement procedures, respectively (see notes 5 and 10).
Collaboration agreement The
Leukemia & Lymphoma Society (LLS)
Affimed is party to a collaboration with LLS to fund the development of specific product
candidates (immune cell engagers). Under the terms of the agreement, LLS has agreed to contribute up to $4.4 million contingent upon the achievement of certain milestones.
In the event that the research and development is successful, Affimed must proceed with commercialization of the licensed product.
If Affimed decides for business reasons not to continue the commercialization, Affimed must at its option either repay the amount funded or grant a license to LLS to enable LLS to continue with the development program. In
addition, LLS is entitled to receive royalties from Affimed based on the Group s future revenue from any licensed product, with the amount of royalties not to exceed three times the amount funded.
In June 2016, the research funding agreement with LLS was amended to reflect a shift to the development of combination therapeutic approaches so that the
milestones now relate primarily to the development of a combination therapy.
During the nine months ended September 30, 2021, the Company did not
recognize any revenue in this regard (2020: 0.1 million).
Collaboration with Genentech Inc.
In August 2018, Affimed entered into a strategic collaboration agreement with Genentech Inc., headquartered in South San Francisco,
USA. Under the terms of the agreement Affimed is providing services related to the development of novel NK cell engager-based immunotherapeutics to treat multiple cancers. The Genentech agreement became effective at the
beginning of October 2018. Under the terms of the agreement, Affimed received $96.0 million ( 83.2 million) in initial upfront and committed funding on October 31, 2018.
The Group recognized 3.8 million and 15.8 million as revenue during the three and nine months ended September 30, 2021 (2020:
10.5 million and 18.1 million). As of September 30, 2021, the Group held contract liabilities of 26.0 million (December 31, 2020: 41.9 million), which will be recognized as revenue in subsequent periods as
services are provided.
Under the terms of the agreement, Affimed is eligible to receive up to an additional $5.0 billion over time, including
payments upon achievement of specified development, regulatory and commercial milestones. Affimed is also eligible to receive royalties on any potential sales. During the second quarter of 2021, Genentech Inc. has informed Affimed that the Phase 1
study of RO7297089 (anti-BCMA/CD16A) was discontinued. A portion of these potential milestone payments are associated with that molecule. This has no impact on the current contract liabilities and future revenue of 26.0 million.
Collaboration with Roivant Sciences Ltd.
On November 9, 2020, Affimed and Pharmavant 6 GmbH, a subsidiary of Roivant Sciences Ltd., announced a strategic
collaboration agreement which grants Roivant a license to the preclinical molecule AFM32. Under the terms of the agreement, Affimed received $60 million in upfront consideration, comprised of $40 million in cash and pre-funded research and development funding, and $20 million of common shares in Roivant. Affimed is eligible to receive additional proceeds in the form of option fees contingent on the
commencement of additional programs contemplated under the agreement. The Company is eligible to receive up to an additional $2 billion in milestone payments over time upon achievement of specified development, regulatory and commercial
milestones, as well as tiered royalties on net sales.
For the three and nine
months ended September 30, 2021 the Group has recognized 4.5 million and 13.4 million as revenue and held 35.6 million under contract liabilities as of September 30,
2021 (December 31, 2020: 49.0 million), which is recognized as revenue in subsequent periods as services are provided.
The Group, through its subsidiary AbCheck s.r.o., has entered into certain research service agreements. These research service agreements
provide for non-refundable upfront technology access research funding or capacity reservation fees and milestone payments. The Group recognized 0.3 million and 0.8 million as revenue in
the three and nine months ended September 30, 2021 (2020: 0.0 million and 0.4 million).
The following table provides information about receivables and contract liabilities from contracts with customers.
| September 30, 2021 | December 31, 2020 | |||||||
| Receivables | 553 | 0 | ||||||
| Contract liabilities | 61,615 | 91,041 |
Amounts of 8.3 million and 29.2 million recognized in contract liabilities at the beginning of the
period have been recognized as revenue during the three and nine months ended September 30, 2021, in respect of Genentech and Roivant.
performance obligations as of September 30, 2021 are approximately 61.6 million and are expected to be recognized as revenue to a large extent over the next two years.
Disaggregation of revenue
| Geographic information | ||||||||||||||||
| Three months ended September 30, 2021 | Three months ended September 30, 2020 | Nine months ended September 30, 2021 | Nine months ended September 30, 2020 | |||||||||||||
| Revenue: | ||||||||||||||||
| Germany | 220 | 0 | 678 | 75 | ||||||||||||
| Europe | 0 | 0 | 0 | 2 | ||||||||||||
| USA | 8,442 | 10,545 | 29,350 | 18,537 | ||||||||||||
| 8,662 | 10,545 | 30,028 | 18,614 |
| Major service lines | ||||||||||||||||
| Three months ended September 30, 2021 | Three months ended September 30, 2020 | Nine months ended September 30, 2021 | Nine months ended September 30, 2020 | |||||||||||||
| Collaboration revenue | 8,327 | 10,539 | 29,215 | 18,255 | ||||||||||||
| Service revenue | 335 | 6 | 813 | 359 | ||||||||||||
| 8,662 | 10,545 | 30,028 | 18,614 |
| Timing on revenue recognition | ||||||||||||||||
| Three months ended September 30, 2021 | Three months ended September 30, 2020 | Nine months ended September 30, 2021 | Nine months ended September 30, 2020 | |||||||||||||
| Point in time | 160 | 8,738 | 340 | 9,021 | ||||||||||||
| Over time | 8,502 | 1,807 | 29,688 | 9,593 | ||||||||||||
| 8,662 | 10,545 | 30,028 | 18,614 |
4. Finance income and finance costs
| Three months ended September 30, 2021 | Three months ended September 30, 2020 | Nine months ended September 30, 2021 | Nine months ended September 30, 2020 | |||||||||||||
| Interest SVB Loan Agreement | (212 | ) | (34 | ) | (493 | ) | (150 | ) | ||||||||
| Foreign exchange differences | 1,809 | (3,033 | ) | 6,222 | (2,478 | ) | ||||||||||
| Finance cost lease liability | (11 | ) | (11 | ) | (36 | ) | (24 | ) | ||||||||
| Other finance income/finance costs | (112 | ) | 21 | (272 | ) | 186 | ||||||||||
| Gain from the modification of SVB Loan Agreement | 0 | 0 | 0 | 62 | ||||||||||||
| Finance income/costs - net | 1,474 | (3,057 | ) | 5,421 | (2,404 | ) |
5. Long term financial assets
The Group holds preferred shares in Amphivena previously recognized at their fair value of 3.0 million. In early October 2021, the Board of
Amphivena took a decision to wind down the company, and we believe the decision indicates that the investment was already impaired on September 30, 2021. Based on the knowledge we currently have, we estimate that the investment is most likely
to have a fair value of nil. This results in a fair value decrease for the three months ended September 30, 2021 of 3.0 million. The fair value decrease for the nine months ending September 30, 2021 amounted to
2.9 million. These fair value changes have been recognized in other comprehensive income. For the valuation of the shares of Amphivena as of September 30, 2021, the Group based its estimate primarily on relevant qualitative information