Full Press Release Details
Unaudited consolidated statements of
| For the three months ended March 31 | ||||||||||
| Note | 2023 | 2022 | ||||||||
| Revenue | 3 | 4,510 | 8,006 | |||||||
| Other income net | 410 | 284 | ||||||||
| Research and development expenses | (29,531 | ) | (18,379 | ) | ||||||
| General and administrative expenses | (6,850 | ) | (7,045 | ) | ||||||
| Operating loss | (31,461 | ) | (17,134 | ) | ||||||
| Finance income / (costs) net | 4 | (519 | ) | 471 | ||||||
| Loss before tax | (31,980 | ) | (16,663 | ) | ||||||
| Income taxes | (3 | ) | (2 | ) | ||||||
| Loss for the period | (31,983 | ) | (16,665 | ) | ||||||
| Other comprehensive loss | ||||||||||
| Items that will not be reclassified to profit or loss | ||||||||||
| Equity investments at fair value OCI net change in fair value | 0 | (6,174 | ) | |||||||
| Other comprehensive loss | 0 | (6,174 | ) | |||||||
| Total comprehensive loss | (31,983 | ) | (22,839 | ) | ||||||
| Basic and diluted loss per share in per share (undiluted = diluted) | (0.21 | ) | (0.14 | ) | ||||||
| Weighted number of common shares outstanding | 149,339,335 | 123,444,217 |
The notes are an integral part of these condensed consolidated interim financial statements.
Consolidated statements of financial position
| Note | March 31, 2023 (unaudited) | December 31, 2022 | ||||||||||
| ASSETS | ||||||||||||
| Non-current assets | ||||||||||||
| Intangible assets | 52 | 58 | ||||||||||
| Leasehold improvements and equipment | 3,673 | 3,823 | ||||||||||
| Right-of-use assets | 436 | 561 | ||||||||||
| 4,161 | 4,442 | |||||||||||
| Current assets | ||||||||||||
| Cash and cash equivalents | 155,848 | 190,286 | ||||||||||
| Trade and other receivables | 6 | 2,042 | 2,697 | |||||||||
| Inventories | 667 | 628 | ||||||||||
| Other assets and prepaid expenses | 7 | 5,240 | 2,459 | |||||||||
| 163,797 | 196,070 | |||||||||||
| TOTAL ASSETS | 167,958 | 200,512 | ||||||||||
| EQUITY AND LIABILITIES | ||||||||||||
| Equity | ||||||||||||
| Issued capital | 1,493 | 1,493 | ||||||||||
| Capital reserves | 587,001 | 582,843 | ||||||||||
| Fair value reserves | (1,231 | ) | (1,231 | ) | ||||||||
| Accumulated deficit | (462,173 | ) | (430,190 | ) | ||||||||
| Total equity | 8 | 125,090 | 152,915 | |||||||||
| Non current liabilities | ||||||||||||
| Borrowings | 10 | 10,344 | 11,687 | |||||||||
| Contract liabilities | 3 | 928 | 1,083 | |||||||||
| Lease liabilities | 158 | 176 | ||||||||||
| Total non-current liabilities | 11,430 | 12,946 | ||||||||||
| Current liabilities | ||||||||||||
| Trade and other payables | 20,147 | 19,077 | ||||||||||
| Borrowings | 10 | 5,930 | 5,930 | |||||||||
| Lease liabilities | 290 | 396 | ||||||||||
| Contract liabilities | 3 | 5,071 | 9,248 | |||||||||
| Total current liabilities | 31,438 | 34,651 | ||||||||||
| TOTAL EQUITY AND LIABILITIES | 167,958 | 200,512 |
The notes are an integral part of these condensed consolidated interim financial statements.
Unaudited consolidated statements of cash flows
| For the three months | ||||||||||||
| ended March 31 | ||||||||||||
| Note | 2023 | 2022 | ||||||||||
| Cash flow from operating activities | ||||||||||||
| Loss for the period | (31,983 | ) | (16,665 | ) | ||||||||
| Adjustments for the period: | ||||||||||||
| - Income taxes | 3 | 2 | ||||||||||
| - Depreciation and amortization | 289 | 352 | ||||||||||
| - Share-based payments | 9 | 4,158 | 4,247 | |||||||||
| - Finance income / (costs) net | 4 | 519 | (471 | ) | ||||||||
| (27,014 | ) | (12,535 | ) | |||||||||
| Change in trade and other receivables | 655 | 262 | ||||||||||
| Change in inventories | (39 | ) | (64 | ) | ||||||||
| Change in other assets and prepaid expenses | (2,781 | ) | (2,435 | ) | ||||||||
| Change in trade, other payables, provisions and contract liabilities | (4,235 | ) | (13,336 | ) | ||||||||
| (33,414 | ) | (28,108 | ) | |||||||||
| Interest received | 520 | 27 | ||||||||||
| Paid interest | (347 | ) | (337 | ) | ||||||||
| Paid income tax | (3 | ) | (2 | ) | ||||||||
| Net cash used in operating activities | (33,244 | ) | (28,420 | ) | ||||||||
| Cash flow from investing activities | ||||||||||||
| Purchase of leasehold improvements and equipment | (8 | ) | (106 | ) | ||||||||
| Net cash used for investing activities | (8 | ) | (106 | ) | ||||||||
| Cash flow from financing activities | ||||||||||||
| Proceeds from issue of common shares, including exercise of share-based payment awards | 0 | 61 | ||||||||||
| Transaction costs related to issue of common shares | 0 | (35 | ) | |||||||||
| Repayment of lease liabilities | (124 | ) | (172 | ) | ||||||||
| Repayment of borrowings | 10 | (510 | ) | (23 | ) | |||||||
| Net cash used for financing activities | (634 | ) | (169 | ) | ||||||||
| Exchange-rate related changes of cash and cash equivalents | (552 | ) | 915 | |||||||||
| Net changes to cash and cash equivalents | (33,886 | ) | (28,695 | ) | ||||||||
| Cash and cash equivalents at the beginning of the period | 190,286 | 197,630 | ||||||||||
| Cash and cash equivalents at the end of the period | 155,848 | 169,850 |
The notes are an integral part of these condensed consolidated interim financial statements.
Unaudited consolidated statements of changes in equity for the year
| Note | Issued capital | Capital reserves | Fair Value reserves | Accumulated deficit | Total equity | |||||||||||||||||||
| 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 | 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 | |||||||||||||||||
| Balance as of January 1, 2023 | 1,493 | 582,843 | (1,231 | ) | (430,190 | ) | 152,915 | |||||||||||||||||
| Equity-settled share-based payment awards | 9 | 4,158 | 4,158 | |||||||||||||||||||||
| Loss for the period | (31,983 | ) | (31,983 | ) | ||||||||||||||||||||
| Balance as of March 31, 2023 | 1,493 | 587,001 | (1,231 | ) | (462,173 | ) | 125,090 |
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.
2. Basis of preparation and changes to Group s accounting policies
Statement of compliance
The condensed consolidated
interim financial statements (referred to as the interim financial statements ) as of March 31, 2023 and December 31, 2022 and for the three months ended March 31, 2023 and 2022 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, 2022.
The interim financial statements were authorized for issuance by the Company s Management Board
common share is calculated by dividing the loss for the period by the weighted average number of common shares outstanding during the period.
March 31, 2023, the Group has granted 25,718,919 options and warrants in connection with share-based payment programs (see note 9) and a loan agreement, 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 due to the net loss generated by the Group.
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
Group s accounting policies were the same as those that applied to the consolidated financial statements as of and for the year ended December 31, 2022.
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, 2022.
New standards and amendments to standards
The following forthcoming 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, 2024 | |||
| Amendments to IAS 1 Presentation of Financial Statements: | ||||
| Non-current Liabilities with Covenants | January 1, 2024 | |||
| Amendments to IFRS 16 Leases: Lease Liability in a | ||||
| Sale and Leaseback | January 1, 2024 |
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, 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
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). The Group recognizes 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 0.2 million and 3.9 million as revenue during the three months
ended March 31, 2023 and 2022, respectively. As of the end of 2022, Affimed had completed work on and/or handed over all product candidates for further investigation by Genentech. The remaining revenue recognized during the three months ended
March 31, 2023 relates to a platform license. As of March 31, 2023, the Group held contract liabilities of 1.5 million (December 31, 2022: 1.7 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.
Roivant Sciences Ltd.
On November 9, 2020, Affimed and Affivant Sciences GmbH (formerly 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. The Group is eligible to receive up to an additional $2 billion in milestone payments upon
achievement of specified development, regulatory and commercial milestones, as well as tiered royalties on net sales.
The Group recognized
4.3 million and 3.9 million as revenue during the three months ended March 31, 2023 and 2022, respectively. As of March 31, 2023, the Group held contract liabilities of 4.3 million (December 31, 2022:
8.6 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.
| March 31, 2023 | December 31, 2022 | |||||||
| Receivables | 12 | 0 | ||||||
| Contract liabilities | 5,999 | 10,331 |
An amount of 4.5 million included in contract liabilities at the beginning of the period has been recognized as
revenue during the three months ended March 31, 2023.
The remaining performance obligations as of March 31, 2023 are approximately 6.0 million and
are expected to be largely recognized as revenue over the next 12 months ( 5.1 million), with a smaller portion being realized thereafter ( 0.9 million).
Disaggregation of revenue
| Three months ended March 31, 2023 | Three months ended March 31, 2022 | |||||||
| Geographic information | ||||||||
| Revenue: | ||||||||
| Germany | 0 | 137 | ||||||
| USA | 4,510 | 7,869 | ||||||
| 4,510 | 8,006 | |||||||
| Major service lines: | ||||||||
| Collaboration revenue | 4,456 | 7,869 | ||||||
| Service revenue | 54 | 137 | ||||||
| 4,510 | 8,006 | |||||||
| Timing on revenue recognition: | ||||||||
| Point in time | 0 | 0 | ||||||
| Over time | 4,510 | 8,006 | ||||||
| 4,510 | 8,006 |
4. Finance income and finance costs
| Three months ended March 31, 2023 | Three months ended March 31, 2022 | |||||||
| Interest SVB Loan Agreement | (477 | ) | (378 | ) | ||||
| Foreign exchange differences | (552 | ) | 915 | |||||
| Other finance income/finance costs net | 510 | (66 | ) | |||||
| (519 | ) | 471 |
5. 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, 2022: nil).
6. Trade and other receivables
The trade receivables as
of March 31, 2023 were 12 (December 31, 2022: 0). 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 0.7 million (December 31, 2022: 1.5 million).
7. Other assets and prepaid expenses
The other assets and prepaid expenses as of March 31, 2023 of 5.2 million (December 31, 2022: 2.5 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 1.1 million (December 31, 2022: 1.1 million) for the reservation of manufacturing capacity, a directors and officers
liability insurance premium of 1.7 million (December 31, 2022: 0 million) and 0.5 million (December 31, 2022: 0.5 million) prepayment for assets secured for new premises.
As of March 31, 2023, the share capital
of 1,493 (December 31, 2022: 1,493) is comprised of 149,339,335 (December 31, 2022: 149,339,335) common shares with a par value of 0.01 per share.
On April 18, 2022, the Company closed its public offering of 25,875,000 common shares (including over-allotment shares) at the public offering price of
$4.00 per share, generating net proceeds of 89.8 million ($97.1 million), after deducting 6.0 million ($6.5 million) in underwriting commissions and other offering expenses.
9. Share-based payments
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, certain members of the Company s Supervisory Board, non-employee consultants and employees.
Share-based payments with service conditions
The majority of the awards vest in instalments over three years and can be exercised up to 10 years after the grant date. The Group granted 7,668,750
awards for the three months ended March 31, 2023 to employees, members of the Management Board and members of the Supervisory Board. Fair value of the awards at grant date amounts to 5.8 million ($6.2 million).