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consolidated statements of comprehensive income / (loss) (in thousand)
| For the three months ended March 31 | ||||||||||
| Note | 2021 | 2020 | ||||||||
| Revenue | 3 | 11,659 | 5,135 | |||||||
| Other income net | 147 | (57 | ) | |||||||
| Research and development expenses | (11,405 | ) | (11,449 | ) | ||||||
| General and administrative expenses | (4,486 | ) | (3,525 | ) | ||||||
| Operating income / (loss) | (4,085 | ) | (9,896 | ) | ||||||
| Finance income / (costs) net | 4 | 5,499 | 1,607 | |||||||
| Income / (loss) before tax | 1,414 | (8,289 | ) | |||||||
| Income taxes | (2 | ) | 0 | |||||||
| Income / (loss) for the period | 1,412 | (8,289 | ) | |||||||
| 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 | (1,253 | ) | 81 | ||||||
| Other comprehensive income / (loss) | (1,253 | ) | 81 | |||||||
| Total comprehensive income / (loss) | 159 | (8,208 | ) | |||||||
| Earnings / (loss) per share in per share (undiluted = diluted) | 0.01 | (0.11 | ) | |||||||
| Weighted number of common shares outstanding | 116,204,455 | 76,249,901 |
The notes are an integral
part of these condensed consolidated interim financial statements.
Consolidated statements of financial position (in thousand)
| Note | March 31, 2021 (unaudited) | December 31, 2020 | ||||||||||
| ASSETS | ||||||||||||
| Non-current assets | ||||||||||||
| Intangible assets | 1,688 | 1,718 | ||||||||||
| Leasehold improvements and equipment | 3,030 | 2,226 | ||||||||||
| Long term financial assets | 5 | 18,789 | 20,042 | |||||||||
| Right-of-use assets | 1,151 | 940 | ||||||||||
| 24,658 | 24,926 | |||||||||||
| Current assets | ||||||||||||
| Cash and cash equivalents | 240,672 | 146,854 | ||||||||||
| Trade and other receivables | 6 | 4,173 | 2,439 | |||||||||
| Inventories | 435 | 246 | ||||||||||
| Other assets | 7 | 648 | 1,260 | |||||||||
| 245,928 | 150,799 | |||||||||||
| TOTAL ASSETS | 270,586 | 175,725 | ||||||||||
| EQUITY AND LIABILITIES | ||||||||||||
| Equity | ||||||||||||
| Issued capital | 1,190 | 983 | ||||||||||
| Capital reserves | 441,644 | 345,164 | ||||||||||
| Fair value reserves | 467 | 1,720 | ||||||||||
| Accumulated deficit | (274,462 | ) | (275,874 | ) | ||||||||
| Total equity | 8 | 168,839 | 71,993 | |||||||||
| Non-current liabilities | ||||||||||||
| Borrowings | 10 | 9,979 | 231 | |||||||||
| Contract liabilities | 3 | 28,550 | 35,992 | |||||||||
| Lease liabilities | 686 | 482 | ||||||||||
| Total non-current liabilities | 39,215 | 36,705 | ||||||||||
| Current liabilities | ||||||||||||
| Trade and other payables | 10,974 | 11,394 | ||||||||||
| Borrowings | 10 | 92 | 92 | |||||||||
| Lease liabilities | 546 | 492 | ||||||||||
| Contract liabilities | 3 | 50,920 | 55,049 | |||||||||
| Total current liabilities | 62,532 | 67,027 | ||||||||||
| TOTAL EQUITY AND LIABILITIES | 270,586 | 175,725 |
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 | 2021 | 2020 | ||||||||||
| Cash flow from operating activities | ||||||||||||
| Income / (loss) for the period | 1,412 | (8,289 | ) | |||||||||
| Adjustments for the period: | ||||||||||||
| - Income taxes | 2 | 0 | ||||||||||
| - Depreciation and amortization | 331 | 280 | ||||||||||
| - Share based payments | 9 | 1,109 | 727 | |||||||||
| - Finance income / costs net | 4 | (5,499 | ) | (1,607 | ) | |||||||
| (2,645 | ) | (8,889 | ) | |||||||||
| Change in trade and other receivables | (1,735 | ) | (750 | ) | ||||||||
| Change in inventories | (189 | ) | (41 | ) | ||||||||
| Change in other assets | 411 | 0 | ||||||||||
| Change in trade, other payables, provisions and contract liabilities | (11,822 | ) | (6,999 | ) | ||||||||
| Cash used in operating activities | (15,980 | ) | (16,679 | ) | ||||||||
| Interest received | 0 | 160 | ||||||||||
| Paid interest | (50 | ) | (28 | ) | ||||||||
| Paid income tax | (2 | ) | 0 | |||||||||
| Net cash used in operating activities | (16,032 | ) | (16,547 | ) | ||||||||
| Cash flow from investing activities | ||||||||||||
| Purchase of intangible assets | (4 | ) | (2 | ) | ||||||||
| Purchase of leasehold improvements and equipment | (962 | ) | (20 | ) | ||||||||
| Cash received from maturity of financial assets | 0 | 3,736 | ||||||||||
| Net cash used for investing activities | (966 | ) | 3,714 | |||||||||
| Cash flow from financing activities | ||||||||||||
| Proceeds from issue of common shares | 8 | 101,860 | 0 | |||||||||
| Transaction costs related to issue of common shares | 8 | (6,350 | ) | 0 | ||||||||
| Proceeds from borrowings | 10 | 10,000 | 0 | |||||||||
| Transaction costs related to borrowings | (201 | ) | 0 | |||||||||
| Repayment of lease liabilities | (92 | ) | (128 | ) | ||||||||
| Repayment of borrowings | (23 | ) | (773 | ) | ||||||||
| Cash flow from financing activities | 105,194 | (901 | ) | |||||||||
| Exchange-rate related changes of cash and cash equivalents | 5,622 | 1,265 | ||||||||||
| Net changes to cash and cash equivalents | 88,196 | (13,734 | ) | |||||||||
| Cash and cash equivalents at the beginning of the period | 146,854 | 95,234 | ||||||||||
| Cash and cash equivalents at the end of the period | 240,672 | 82,765 |
The notes are an integral
part of these condensed consolidated interim financial statements.
Unaudited 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 | ||||||||||||||||||
| Equity-settled share based payment awards | 9 | 727 | 727 | |||||||||||||||||||||
| Loss for the period | (8,289 | ) | (8,289 | ) | ||||||||||||||||||||
| Other comprehensive income | 81 | 81 | ||||||||||||||||||||||
| Balance as of March 31, 2020 | 762 | 271,178 | 2,043 | (242,797 | ) | 31,186 | ||||||||||||||||||
| Balance as of January 1, 2021 | 983 | 345,164 | 1,720 | (275,874 | ) | 71,993 | ||||||||||||||||||
| Issue of common shares | 8 | 204 | 94,215 | 94,419 | ||||||||||||||||||||
| Exercise of share based payment awards | 3 | 1,156 | 1,159 | |||||||||||||||||||||
| Equity-settled share based payment awards | 9 | 1,109 | 1,109 | |||||||||||||||||||||
| Income for the period | 1,412 | 1,412 | ||||||||||||||||||||||
| Other comprehensive income | (1,253 | ) | (1,253 | ) | ||||||||||||||||||||
| Balance as of March 31, 2021 | 1,190 | 441,644 | 467 | (274,462 | ) | 168,839 |
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 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, Affimed Inc., Delaware, USA and AbCheck 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.
2. Basis of preparation and changes to Group s accounting policies
Statement of compliance
The condensed consolidated
interim financial statements (referred to as interim financial statements ) for the three months ended March 31, 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 July 1, 2021.
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, 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
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 amendments to standards
The following new 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 AS 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 IFRS 16 Leases: Covid-19-Related Rent Concessions beyond 30 June 2021 | April 1, 2021 | |
| 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 measurement:
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 9).
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 three months ended March 31, 2021, the Company did not
recognize any revenue in this regard (March 31, 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.
recognized 8.4 million and 4.8 million as revenue during the three months ended March 31, 2021 and 2020, respectively. As of March 31, 2021, contract liabilities of 33.4 million (December 31, 2020:
41.9 million) 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., 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.
For the three months ended
March 31, 2021 the Group has recognized 3.0 million as revenue and held 46.0 million under contract liabilities as of March 31, 2021 (December 31, 2020: 49.0 million), which is recognized as revenue in
subsequent periods as services are provided.
Research service agreements
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 as revenue in the three months ended March 31, 2021
(2020: 0.2 million).
The following table provides information about receivables and contract liabilities from contracts with customers.
| March 31, 2021 | December 31, 2020 | |||||||
| Receivables | 130 | 0 | ||||||
| Contract liabilities | 79,470 | 91,041 |
An amount of 11.7 million recognized in contract liabilities at the beginning of the period has been recognized as
revenue during the three months ended March 31, 2021.
The remaining performance obligations as of March 31, 2021 are approximately
79.5 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 March 31, 2021 | Three months ended March 31, 2020 | |||||||
| Revenue: | ||||||||
| Germany | 236 | 75 | ||||||
| Europe | 0 | 2 | ||||||
| USA | 11,423 | 5,058 | ||||||
| 11,659 | 5.135 |
| Major service lines | ||||||||
| Three months ended March 31, 2021 | Three months ended March 31, 2020 | |||||||
| Collaboration revenue | 11,403 | 4,923 | ||||||
| Service revenue | 256 | 212 | ||||||
| 11,659 | 5,135 |
| Timing on revenue recognition | ||||||||
| Three months ended March 31, 2021 | Three months ended March 31, 2020 | |||||||
| Point in time | 60 | 177 | ||||||
| Over time | 11,599 | 4,958 | ||||||
| 11,659 | 5,135 |
4. Finance income and finance costs
| Three months ended March 31, 2021 | Three months ended March 31, 2020 | |||||||
| Interest SVB Loan Agreement | (73 | ) | (57 | ) | ||||
| Foreign exchange differences | 5,622 | 1,576 | ||||||
| Finance cost lease liability | (12 | ) | (7 | ) | ||||
| Other finance income/finance costs | (38 | ) | 95 | |||||
| Finance income/costs - net | 5,499 | 1,607 |
5. Long term financial assets
The Group holds preferred shares in Amphivena recognized at their fair value of 3.1 million. During the three months ended March 31, 2021 the
fair value increased by 0.1 million due to exchange rate differences recognized in other comprehensive income (three months ended March 31, 2020: 0.1 million).
The Group also holds common shares in Roivant Sciences Ltd at their fair value of 15.7 million. During the three months ended March 31, 2021
the fair value decreased by 1.4 million due to a decline in the carrying value of certain of the Roivant subsidiaries recognized in other comprehensive income.
For the valuation of the shares of Amphivena, the Group based its estimate primarily on observable financing round valuations and considered certain other
publicly available information as well as relevant qualitative information provided by Amphivena as of the respective valuation dates (level 3). The fair value of the shares in Roivant was based on an observable financing round valuation, which was
adjusted as of the respective valuation dates considering certain assumptions such as the development of quoted market prices of peer companies and other publicly available information as well as quantitative and qualitative information provided by
6. Trade and other receivables
Trade and other receivables mainly comprise Directors and Officers liability insurance prepayment of 1.4 million (December 31, 2020: 0