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Unaudited consolidated statements of
comprehensive income / (loss)
| For the three months ended | ||||||||||||
| March 31 | ||||||||||||
| Note | 2022 | 2021 | ||||||||||
| Revenue | 3 | 8,006 | 11,659 | |||||||||
| Other income net | 284 | 147 | ||||||||||
| Research and development expenses | (18,379 | ) | (11,405 | ) | ||||||||
| General and administrative expenses | (7,045 | ) | (4,486 | ) | ||||||||
| Operating income / (loss) | (17,134 | ) | (4,085 | ) | ||||||||
| Finance income / (costs) net | 4 | 471 | 5,499 | |||||||||
| Income / (loss) before tax | (16,663 | ) | 1,414 | |||||||||
| Income taxes | (2 | ) | (2 | ) | ||||||||
| Income / (loss) for the period | (16,665 | ) | 1,412 | |||||||||
| 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 | (6,174 | ) | (1,253 | ) | |||||||
| Other comprehensive income / (loss) | (6,174 | ) | (1,253 | ) | ||||||||
| Total comprehensive income / (loss) | (22,839 | ) | 159 | |||||||||
| Basic and diluted earnings / (loss) per share in per share | (0.14 | ) | 0.01 | |||||||||
| (undiluted = diluted) | ||||||||||||
| Weighted number of common shares outstanding | 123,444,217 | 116,204,455 |
The notes are an integral part of these condensed consolidated interim financial statements.
Consolidated statements of financial position
| Note | March 31, 2022 | December 31, 2021 | ||||||||||
| (unaudited) | ||||||||||||
| ASSETS | ||||||||||||
| Non-current assets | ||||||||||||
| Intangible assets | 1,580 | 1,607 | ||||||||||
| Leasehold improvements and equipment | 3,754 | 3,814 | ||||||||||
| Long-term financial assets | 5 | 6,174 | 12,348 | |||||||||
| Right-of-use assets | 813 | 972 | ||||||||||
| 12,321 | 18,741 | |||||||||||
| Current assets | ||||||||||||
| Cash and cash equivalents | 169,850 | 197,630 | ||||||||||
| Trade and other receivables | 6 | 4,547 | 4,809 | |||||||||
| Inventories | 485 | 421 | ||||||||||
| Other assets and prepaid expenses | 7 | 6,048 | 3,534 | |||||||||
| 180,930 | 206,394 | |||||||||||
| TOTAL ASSETS | 193,251 | 225,135 | ||||||||||
| EQUITY AND LIABILITIES | ||||||||||||
| Equity | ||||||||||||
| Issued capital | 1,234 | 1,234 | ||||||||||
| Capital reserves | 478,395 | 474,087 | ||||||||||
| Fair value reserves | (12,147 | ) | (5,973 | ) | ||||||||
| Accumulated deficit | (350,062 | ) | (333,397 | ) | ||||||||
| Total equity | 8 | 117,420 | 135,951 | |||||||||
| Non-current liabilities | ||||||||||||
| Borrowings | 10 | 15,713 | 17,060 | |||||||||
| Contract liabilities | 3 | 2,035 | 7,209 | |||||||||
| Lease liabilities | 288 | 368 | ||||||||||
| Total non-current liabilities | 18,036 | 24,637 | ||||||||||
| Current liabilities | ||||||||||||
| Trade and other payables | 13,537 | 18,860 | ||||||||||
| Borrowings | 10 | 2,039 | 580 | |||||||||
| Lease liabilities | 592 | 683 | ||||||||||
| Contract liabilities | 3 | 41,627 | 44,424 | |||||||||
| Total current liabilities | 57,795 | 64,547 | ||||||||||
| TOTAL EQUITY AND LIABILITIES | 193,251 | 225,135 |
The notes are an integral part of these condensed consolidated interim financial statements.
Unaudited consolidated statements of cash flows (in thousand)
| For the three months ended | ||||||||||||
| March 31 | ||||||||||||
| Note | 2022 | 2021 | ||||||||||
| Cash flow from operating activities | ||||||||||||
| Income / (loss) for the period | (16,665 | ) | 1,412 | |||||||||
| Adjustments for the period: | ||||||||||||
| - Income taxes | 2 | 2 | ||||||||||
| - Depreciation and amortization | 352 | 331 | ||||||||||
| - Share-based payments | 9 | 4,247 | 1,109 | |||||||||
| - Finance income / costs net | 4 | (471 | ) | (5,499 | ) | |||||||
| (12,535 | ) | (2,645 | ) | |||||||||
| Change in trade and other receivables | 262 | (1,735 | ) | |||||||||
| Change in inventories | (64 | ) | (189 | ) | ||||||||
| Change in other assets and prepaid expenses | (2,435 | ) | 411 | |||||||||
| Change in trade, other payables, provisions and contract liabilities | (13,336 | ) | (11,822 | ) | ||||||||
| (28,108 | ) | (15,980 | ) | |||||||||
| Interest received | 27 | 0 | ||||||||||
| Paid interest | (337 | ) | (50 | ) | ||||||||
| Paid income tax | (2 | ) | (2 | ) | ||||||||
| Net cash used in operating activities | (28,420 | ) | (16,032 | ) | ||||||||
| Cash flow from investing activities | ||||||||||||
| Purchase of intangible assets | 0 | (4 | ) | |||||||||
| Purchase of leasehold improvements and equipment | (106 | ) | (962 | ) | ||||||||
| Net cash used for investing activities | (106 | ) | (966 | ) | ||||||||
| Cash flow from financing activities | ||||||||||||
| Proceeds from issue of common shares, including exercise of share-based payment awards | 61 | 101,860 | ||||||||||
| Transaction costs related to issue of common shares | (35 | ) | (6,350 | ) | ||||||||
| Proceeds from borrowings | 10 | 0 | 10,000 | |||||||||
| Transaction costs related to borrowings | 0 | (201 | ) | |||||||||
| Repayment of lease liabilities | (172 | ) | (92 | ) | ||||||||
| Repayment of borrowings | 10 | (23 | ) | (23 | ) | |||||||
| Cash flow from financing activities | (169 | ) | 105,194 | |||||||||
| Exchange rate related changes of cash and cash equivalents | 915 | 5,622 | ||||||||||
| Net changes to cash and cash equivalents | (28,695 | ) | 88,196 | |||||||||
| Cash and cash equivalents at the beginning of the period | 197,630 | 146,854 | ||||||||||
| Cash and cash equivalents at the end of the period | 169,850 | 240,672 |
The notes are an integral part of these condensed consolidated interim financial statements.
Unaudited consolidated statements of changes in equity
| Note | Issued capital | Capital reserves | Fair value reserves | Accumulated deficit | Total equity | |||||||||||||||||||
| Balance as of January 1, 2021 | 983 | 345,164 | 1,720 | (275,874 | ) | 71,993 | ||||||||||||||||||
| Issue of common shares | 204 | 94,215 | 94,419 | |||||||||||||||||||||
| Exercise of share-based payment awards | 3 | 1,156 | 1,159 | |||||||||||||||||||||
| Equity-settled share-based payment awards | 1,109 | 1,109 | ||||||||||||||||||||||
| Income for the period | 1,412 | 1,412 | ||||||||||||||||||||||
| Other comprehensive loss | (1,253 | ) | (1,253 | ) | ||||||||||||||||||||
| Balance as of March 31, 2021 | 1,190 | 441,644 | 467 | (274,462 | ) | 168,839 | ||||||||||||||||||
| Balance as of January 1, 2022 | 1,234 | 474,087 | (5,973 | ) | (333,397 | ) | 135,951 | |||||||||||||||||
| Exercise of share-based payment awards | 61 | 61 | ||||||||||||||||||||||
| Equity-settled share-based payment awards | 9 | 4,247 | 4,247 | |||||||||||||||||||||
| Loss for the period | (16,665 | ) | (16,665 | ) | ||||||||||||||||||||
| Other comprehensive loss | (6,174 | ) | (6,174 | ) | ||||||||||||||||||||
| Balance as of March 31, 2022 | 1,234 | 478,395 | (12,147 | ) | (350,062 | ) | 117,420 |
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 interim financial statements ) for the three months ended March 31, 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 December 31, 2021.
The interim financial statements were authorized for issuance by the management board on June 1, 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 March 31, 2022, the Group has
granted 16,278,740 options and warrants in connection with share-based payment programs (see note 9) 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
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, 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, 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 note 5). The Group recognises transfers between levels of the fair value hierarchy as at
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 3.9 million and 8.4 million as revenue during the three months
ended March 31, 2022 and 2021, respectively. As of March 31, 2022, contract liabilities of 16.3 million (December 31, 2021: 20.2 million) 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.
Roivant Sciences Ltd.
On 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 3.9 million and 3.0 million as revenue during the three months
ended March 31, 2022 and 2021,
respectively. As of March 31, 2022, contract liabilities of 27.4 million (December 31, 2021:
31.3 million) will be recognized as revenue in subsequent periods as services are provided.
Research service agreements
The Group 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 0.1 million as revenue in the three months ended March 31,
2022 (2021: 0.3 million).
The following table provides information about receivables and contract liabilities from contracts with customers.
| March 31, 2022 | December 31, 2021 | |||||||
| Receivables | 25 | 150 | ||||||
| Contract liabilities | 43,662 | 51,633 |
An amount of 8.0 million recognized in contract liabilities at the beginning of the period has been recognized as
revenue during the three months ended March 31, 2022.
The remaining performance obligations as of March 31, 2022 are approximately
43.7 million and are expected to be largely recognized as revenue over the next 12 months ( 41.7 million), with a smaller portion being realized the 12 months thereafter ( 2.0 million).
Disaggregation of revenue
| Three months ended March 31, 2022 | Three months ended March 31, 2021 | |||||||
| Geographic information | ||||||||
| Revenue: | ||||||||
| Germany | 137 | 236 | ||||||
| USA | 7,869 | 11,423 | ||||||
| 8,006 | 11,659 | |||||||
| Major service lines: | ||||||||
| Collaboration revenue | 7,869 | 11,403 | ||||||
| Service revenue | 137 | 256 | ||||||
| 8,006 | 11,659 | |||||||
| Timing on revenue recognition: | ||||||||
| Point in time | 0 | 60 | ||||||
| Over time | 8,006 | 11,599 | ||||||
| 8,006 | 11,659 |
| Three months ended March 31, 2022 | Three months ended March 31, 2021 | |||||||
| Interest SVB Loan Agreement | (378 | ) | (73 | ) | ||||
| Foreign exchange differences | 915 | 5,622 | ||||||
| Other finance income/finance costs - net | (66 | ) | (50 | ) | ||||
| 471 | 5,499 |
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).
The Group also holds common shares in Roivant at their fair value of 6.2 million (December 31, 2021: 12.3 million). During the three months
ended March 31, 2022 the fair value decreased by 6.2 million due to a decline in the quoted market price for Roivant s common shares, and this decline has been recognized in other comprehensive income. During the three months
ended March 31, 2021 the fair value decreased by 1.4 million.
The trade receivables as of March 31, 2022, were 25 (December 31, 2021: 150), these 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 3.6 million (December 31, 2021: 2.7 million).
The other assets and prepaid expenses as of March 31, 2022 of 6.0 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 2.5 million (December 31, 2021: 2.9 million) for the reservation of manufacturing capacity and a Directors and
Officers liability insurance premium of 2.2 million (December 31, 2021: 0 million).
As of March 31, 2022, the share capital of 1,234 (December 31, 2021: 1,234) is comprised of 123,445,341 (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 the sales over time of up to $100 million of its common shares.
In 2014, an equity-settled share-based payment program was established by Affimed N.V. (ESOP 2014). Under this program, the Company granted awards to certain
members of the Management Board, the Supervisory Board, non-employee consultants and employees.