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Unaudited consolidated interim
statements of comprehensive income / (loss)
| For the three months ended September | For the nine months ended September | |||||||||||||||||||
| Note | 2022 | 2021 | 2022 | 2021 | ||||||||||||||||
| Revenue | 3 | 14,888 | 8,662 | 30,195 | 30,028 | |||||||||||||||
| Other income net | 118 | 231 | 642 | 710 | ||||||||||||||||
| Research and development expenses | (26,126 | ) | (20,621 | ) | (65,333 | ) | (53,826 | ) | ||||||||||||
| General and administrative expenses | (8,089 | ) | (6,841 | ) | (23,509 | ) | (16,766 | ) | ||||||||||||
| Operating loss | (19,209 | ) | (18,569 | ) | (58,005 | ) | (39,854 | ) | ||||||||||||
| Finance income / (costs) net | 4 | 2,719 | 1,474 | 5,443 | 5,421 | |||||||||||||||
| Loss before tax | (16,490 | ) | (17,095 | ) | (52,562 | ) | (34,433 | ) | ||||||||||||
| Income taxes | 0 | 0 | (2 | ) | (2 | ) | ||||||||||||||
| Loss for the period | (16,490 | ) | (17,095 | ) | (52,564 | ) | (34,435 | ) | ||||||||||||
| 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 | (73 | ) | (3,489 | ) | (6,846 | ) | (8,838 | ) | |||||||||||
| Other comprehensive income / (loss) | (73 | ) | (3,489 | ) | (6,846 | ) | (8,838 | ) | ||||||||||||
| Total comprehensive income / (loss) | (16,563 | ) | (20,584 | ) | (59,410 | ) | (43,273 | ) | ||||||||||||
| Basic and diluted earnings / (loss) per share in per share (undiluted = diluted) | (0.11 | ) | (0.14 | ) | (0.38 | ) | (0.29 | ) | ||||||||||||
| Weighted number of common shares outstanding | 149,339,335 | 119,786,695 | 140,036,614 | 118,545,453 |
The Notes are an integral part of these condensed consolidated interim financial statements.
Consolidated interim statements of financial position
| Note | September 30, 2022 | December 31, 2021 | ||||||||||
| (unaudited) | ||||||||||||
| ASSETS | ||||||||||||
| Non-current assets | ||||||||||||
| Intangible assets | 1,555 | 1,607 | ||||||||||
| Leasehold improvements and equipment | 3,584 | 3,814 | ||||||||||
| Long-term financial assets | 6 | 0 | 12,348 | |||||||||
| Right-of-use assets | 710 | 972 | ||||||||||
| 5,849 | 18,741 | |||||||||||
| Current assets | ||||||||||||
| Cash and cash equivalents | 222,895 | 197,630 | ||||||||||
| Trade and other receivables | 7 | 1,691 | 4,809 | |||||||||
| Inventories | 673 | 421 | ||||||||||
| Assets held for sale | 5 | 1,731 | 0 | |||||||||
| Other assets and prepaid expenses | 8 | 3,560 | 3,534 | |||||||||
| 230,550 | 206,394 | |||||||||||
| TOTAL ASSETS | 236,399 | 225,135 | ||||||||||
| EQUITY AND LIABILITIES | ||||||||||||
| Equity | ||||||||||||
| Issued capital | 1,493 | 1,234 | ||||||||||
| Capital reserves | 578,390 | 474,087 | ||||||||||
| Fair value reserves | (5,954 | ) | (5,973 | ) | ||||||||
| Accumulated deficit | (392,826 | ) | (333,397 | ) | ||||||||
| Total equity | 9 | 181,103 | 135,951 | |||||||||
| Non current liabilities | ||||||||||||
| Borrowings | 11 | 13,027 | 17,060 | |||||||||
| Contract liabilities | 3 | 1,238 | 7,209 | |||||||||
| Lease liabilities | 203 | 368 | ||||||||||
| Total non-current liabilities | 14,468 | 24,637 | ||||||||||
| Current liabilities | ||||||||||||
| Trade and other payables | 15,078 | 18,860 | ||||||||||
| Borrowings | 11 | 4,957 | 580 | |||||||||
| Lease liabilities | 541 | 683 | ||||||||||
| Contract liabilities | 3 | 20,252 | 44,424 | |||||||||
| Total current liabilities | 40,828 | 64,547 | ||||||||||
| TOTAL EQUITY AND LIABILITIES | 236,399 | 225,135 |
The Notes are an integral part of these condensed consolidated interim financial statements.
Unaudited consolidated interim statements of cash flows
| For the nine months ended September 30, | ||||||||||||
| Note | 2022 | 2021 | ||||||||||
| Cash flow from operating activities | ||||||||||||
| Income / (loss) for the period | (52,564 | ) | (34,435 | ) | ||||||||
| Adjustments for the period: | ||||||||||||
| - Income taxes | 2 | 2 | ||||||||||
| - Depreciation and amortization | 1,066 | 935 | ||||||||||
| - Net gain / loss from disposal of leasehold improvements and equipment | 0 | (2 | ) | |||||||||
| - Share-based payments | 10 | 14,779 | 8,117 | |||||||||
| - Finance income / costs net | 4 | (5,443 | ) | (5,421 | ) | |||||||
| (42,160 | ) | (30,804 | ) | |||||||||
| Change in trade and other receivables | 3,118 | (1,320 | ) | |||||||||
| Change in inventories | (252 | ) | (446 | ) | ||||||||
| Change in other assets and prepaid expenses | (26 | ) | 1,064 | |||||||||
| Change in trade, other payables, provisions and contract liabilities | (33,888 | ) | (26,802 | ) | ||||||||
| (73,208 | ) | (58,308 | ) | |||||||||
| Interest received | 228 | 0 | ||||||||||
| Paid interest | (950 | ) | (647 | ) | ||||||||
| Paid income tax | (2 | ) | (2 | ) | ||||||||
| Net cash used in operating activities | (73,932 | ) | (58,957 | ) | ||||||||
| Cash flow from investing activities | ||||||||||||
| Purchase of intangible assets | (30 | ) | (5 | ) | ||||||||
| Purchase of leasehold improvements and equipment | (263 | ) | (1,527 | ) | ||||||||
| Cash received from the sale of financial assets | 5 | 3,772 | 0 | |||||||||
| Net cash used for investing activities | 3,479 | (1,532 | ) | |||||||||
| Cash flow from financing activities | ||||||||||||
| Proceeds from issue of common shares, including exercise of share-based payment awards | 95,907 | 103,379 | ||||||||||
| Transaction costs related to issue of common shares | (6,159 | ) | (6,548 | ) | ||||||||
| Proceeds from borrowings | 11 | 0 | 10,000 | |||||||||
| Transaction costs related to borrowings | 0 | (236 | ) | |||||||||
| Repayment of lease liabilities | (538 | ) | (372 | ) | ||||||||
| Repayment of borrowings | 11 | (70 | ) | (69 | ) | |||||||
| Cash flow from financing activities | 89,140 | 106,154 | ||||||||||
| Exchange-rate related changes of cash and cash equivalents | 6,578 | 6,223 | ||||||||||
| Net changes to cash and cash equivalents | 18,687 | 45,665 | ||||||||||
| Cash and cash equivalents at the beginning of the period | 197,630 | 146,854 | ||||||||||
| Cash and cash equivalents at the end of the period | 222,895 | 198,742 |
The Notes are an integral part of these condensed consolidated interim financial statements.
Unaudited consolidated interim statements of changes in equity
| Issued capital | Capital reserves | Fair Value reserves | Accumulated deficit | Total equity | ||||||||||||||||||||
| Note | ||||||||||||||||||||||||
| Balance as of January 1, 2021 | 983 | 345,164 | 1,720 | (275,874 | ) | 71,993 | ||||||||||||||||||
| Issue of common shares | 205 | 94,138 | 94,343 | |||||||||||||||||||||
| Exercise of share-based payment awards | 10 | 2,667 | 2,677 | |||||||||||||||||||||
| Equity-settled share-based payment awards | 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 | |||||||||||||||||
| Balance as of January 1, 2022 | 1,234 | 474,087 | (5,973 | ) | (333,397 | ) | 135,951 | |||||||||||||||||
| Issue of common shares | 9 | 259 | 89,423 | 89,682 | ||||||||||||||||||||
| Exercise of share-based payment awards | 101 | 101 | ||||||||||||||||||||||
| Equity-settled share-based payment awards | 10 | 14,779 | 14,779 | |||||||||||||||||||||
| Transfer of cumulative loss on sale of financial assets | 5 | 6,865 | (6,865 | ) | 0 | |||||||||||||||||||
| Loss for the period | (52,564 | ) | (52,564 | ) | ||||||||||||||||||||
| Other comprehensive loss | (6,846 | ) | (6,846 | ) | ||||||||||||||||||||
| Balance as of September 30, 2022 | 1,493 | 578,390 | (5,954 | ) | (392,826 | ) | 181,103 |
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, registered with
the trade register of the Chamber of Commerce (handelsregister van de Kamer van Koophandel) under number 60673389.
The condensed consolidated interim
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.
Statement of compliance
The condensed consolidated
interim financial statements (referred to as the interim financial statements ) for the three and nine months ended September 30, 2022 and 2021 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
The interim financial statements were authorized for issuance by the management board of the Company (the Management
Board ) on November 15, 2022.
Loss per common share is calculated by dividing the loss for the period by the weighted average number of common shares outstanding during the period.
As of September 30, 2022, the Group has granted 18,107,777 options and warrants in connection with share-based payment programs (see note 10) and certain
loan agreements, which could potentially have a dilutive effect but were excluded from the diluted weighted average number of ordinary shares calculation because their effect would have been anti-dilutive.
Critical judgments and accounting estimates
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
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, 2021.
Functional and presentation currency
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
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, 2021.
New standards and amendments to standards
The following new standards and amendments to standards have not been applied in preparing these interim financial statements.
| Standard/interpretation | Effective Date 1 | |||
| 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 interim 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 measurement:
The carrying amount of all trade and other
receivables, other assets and prepaid expenses, certificates of deposit, cash and cash equivalents, trade and other payables and loans 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 preferred and common shares in other companies held by the group is based on level 1 and 3 inputs (see notes 5 and 6). The Group recognises transfers between levels
of the fair value hierarchy as the date at which the change has occurred.
Collaboration with Genentech Inc.
Affimed entered into a strategic collaboration agreement with Genentech Inc. (Genentech), 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 9.9 million and 17.1 million as revenue during the three and
nine months ended September 30, 2022 (2021: 3.8 million and 15.8 million). As of September 30, 2022, the Group held contract liabilities of 3.1 million (December 31, 2021: 20.2 million), which will be
recognized as revenue in subsequent periods.
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.
Collaboration with Roivant Sciences Ltd.
November 9, 2020, Affimed and Pharmavant 6 GmbH, a subsidiary of Roivant Sciences Ltd. (Roivant), 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 milestones over time
upon achievement of specified development, regulatory and commercial milestones, as well as tiered royalties on net sales.
The Group recognized
5.0 million and 12.9 million as revenue during the three and nine months ended September 30, 2022 (2021: 4.5 million and 13.4 million). As of September 30, 2022, the Group held contract liabilities of
18.4 million (December 31, 2021: 31.3 million), which will be recognized as revenue in subsequent periods as services are provided.
The following table provides information about receivables and contract liabilities from contracts with customers.
| September 30, 2022 | December 31, 2021 | |||||||
| Receivables | 36 | 150 | ||||||
| Contract liabilities | 21,490 | 51,633 |
An amount of 14.9 million and 30.2 million recognized in contract liabilities at the beginning of the
period has been recognized as revenue during the three and nine months ended September 30, 2022.
The remaining performance obligations as of
September 30, 2022 are approximately 21.5 million and are expected to be largely recognized as revenue over the next 12 months ( 20.3 million), with a smaller portion being realized thereafter ( 1.2 million).
Disaggregation of revenue
| Three months ended September 30, 2022 | Three months ended September 30, 2021 | Nine months ended September 30, 2022 | Nine months ended September 30, 2021 | |||||||||||||
| Geographic information | ||||||||||||||||
| Revenue: | ||||||||||||||||
| Germany | 0 | 220 | 151 | 678 | ||||||||||||
| USA | 14,888 | 8,442 | 30,044 | 29,350 | ||||||||||||
| 14,888 | 8,662 | 30,195 | 30,028 | |||||||||||||
| Major service lines: | ||||||||||||||||
| Collaboration revenue | 14,888 | 8,327 | 30,041 | 29,215 | ||||||||||||
| Service revenue | 0 | 335 | 154 | 813 | ||||||||||||
| 14,888 | 8,662 | 30,195 | 30,028 | |||||||||||||
| Timing on revenue recognition: | ||||||||||||||||
| Point in time | 0 | 160 | 0 | 340 | ||||||||||||
| Over time | 14,888 | 8,502 | 30,195 | 29,688 | ||||||||||||
| 14,888 | 8,662 | 30,195 | 30,028 |
4. Finance income and finance costs
| Three months ended September 30, 2022 | Three months ended September 30, 2021 | Nine months ended September 30, 2022 | Nine months ended September 30, 2021 | |||||||||||||
| Interest SVB Loan Agreement | (408 | ) | (212 | ) | (1,167 | ) | (493 | ) | ||||||||
| Foreign exchange differences | 3,009 | 1,809 | 6,577 | 6,222 | ||||||||||||
| Other finance income/finance costs net | 118 | (123 | ) | 33 | (308 | ) | ||||||||||
| 2,719 | 1,474 | 5,443 | 5,421 |
5. Assets held for sale
The Group holds common shares in Roivant and made a strategic decision in June 2022 to dispose of this investment in tranches within the next 12 months. During
the three and nine months ended September 30, 2022, Affimed sold 511,506 and 863,547 of these shares (representing 37% and 62% of the total shares held) at a weighted average selling price of 4.41 ($4.46) and 4.37 ($4.49) resulting
in net proceeds of 2.3 million and 3.8 million, respectively. The cumulated loss on sale for the three and nine months ended September 30, 2022 of 4.0 million and 6.9 million was reclassified within
equity from the fair value reserve to the accumulated deficit. The quoted market price for Roivant s common shares declined in the three months ended September 30, 2022, resulting in a decline in the fair value of 0.1 million
recognized in other comprehensive income. As of September 30, 2022, the Group s investment in Roivant had a fair value of 1.7 million.
6. Long-term financial assets
The Group holds preferred
shares in Amphivena, which are currently recognized at their fair value of nil. The impairment of the asset was recognized in 2021 based on the decision made by the board of Amphivena to wind down the company. Based on current information, we
continue to estimate that the fair value remains at nil (December 31, 2021: nil).
As of December 31, 2021, the long-term financial assets included
the Group s investment in Roivant at its fair value of 12.3 million. The common shares held in Roivant have been reclassified as assets held for sale (refer to note 5) as part of a strategic decision was taken in June 2022 to sell
7. Trade and other receivables
trade receivables as of September 30, 2022, were 36 (December 31, 2021: 150). These trade receivables are all due in the short-term, do not bear interest and are not impaired. Other receivables are all due within the short-term
and mainly comprise value-added tax receivables of 0.8 million (December 31, 2021: 2.7 million).
8. Other assets and prepaid expenses
The other assets and prepaid expenses as of September 30, 2022 of 3.6 million (December 31, 2021: 3.5 million) are short-term in
nature, do not bear interest and are not impaired. The other assets and prepaid expenses mainly comprise a prepayment of 1.7 million (December 31, 2021: 2.9 million) for the reservation of manufacturing capacity,
0.3 million (December 31, 2021: 0 million) as prepayment for manufacturing activities and a directors and officers liability insurance premium of 0.8 million (December 31, 2021: 0 million).
As of September 30, 2022, the share
capital of 1,493 (December 31, 2021: 1,234) is comprised of 149,339,335 (December 31, 2021: 123,419,772) common shares with a par value of 0.01 per share.
In November 2021, the Company entered into an agreement for a new at-the-market ( ATM ) program providing for sales over time of up to $100 million of its common shares.