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consolidated statements of comprehensive income/(loss) (in thousands)
| For the three months ended September 30 | For the nine months ended September 30 | |||||||||||||||||||
| Note | 2020 | 2019 | 2020 | 2019 | ||||||||||||||||
| Revenue | 3 | 10,545 | 2,103 | 18,614 | 17,464 | |||||||||||||||
| Other income net | 102 | 49 | 130 | 332 | ||||||||||||||||
| Research and development expenses | (10,101 | ) | (11,721 | ) | (33,247 | ) | (31,253 | ) | ||||||||||||
| General and administrative expenses | (3,455 | ) | (2,790 | ) | (9,586 | ) | (7,566 | ) | ||||||||||||
| Operating income / (loss) | (2,909 | ) | (12,359 | ) | (24,089 | ) | (21,023 | ) | ||||||||||||
| Finance income / (costs) net | 4 | (3,057 | ) | 1,475 | (2,404 | ) | 1,655 | |||||||||||||
| Loss before tax | (5,966 | ) | (10,884 | ) | (26,493 | ) | (19,368 | ) | ||||||||||||
| Income taxes | 0 | 0 | 0 | (4 | ) | |||||||||||||||
| Loss for the period | (5,966 | ) | (10,884 | ) | (26,493 | ) | (19,372 | ) | ||||||||||||
| 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 | (139 | ) | (555 | ) | (129 | ) | (531 | ) | |||||||||||
| Other comprehensive income / (loss) | (139 | ) | (555 | ) | (129 | ) | (531 | ) | ||||||||||||
| Total comprehensive loss | (6,105 | ) | (11,439 | ) | (26,622 | ) | (19,903 | ) | ||||||||||||
| Loss per share in per share (undiluted = diluted) | (0.07 | ) | (0.17 | ) | (0.33 | ) | (0.31 | ) | ||||||||||||
| Weighted number of common shares outstanding | 86,030,878 | 62,443,550 | 80,490,155 | 62,437,673 |
The Notes are an integral part of these consolidated financial statements.
Consolidated statements of financial position (in thousands)
| September 30, 2020 | December 31, 2019 | |||||||||||
| Note | (unaudited) | |||||||||||
| ASSETS | ||||||||||||
| Non-current assets | ||||||||||||
| Intangible assets | 93 | 137 | ||||||||||
| Leasehold improvements and equipment | 2,305 | 2,291 | ||||||||||
| Long term financial assets | 5 | 3,064 | 3,193 | |||||||||
| Right-of-use assets | 1,084 | 824 | ||||||||||
| 6,546 | 6,445 | |||||||||||
| Current assets | ||||||||||||
| Cash and cash equivalents | 89,656 | 95,234 | ||||||||||
| Financial assets | 6 | 7,687 | 8,902 | |||||||||
| Trade and other receivables | 2,552 | 1,482 | ||||||||||
| Inventories | 410 | 296 | ||||||||||
| Other assets | 1,087 | 0 | ||||||||||
| 101,392 | 105,914 | |||||||||||
| TOTAL ASSETS | 107,938 | 112,359 | ||||||||||
| EQUITY AND LIABILITIES | ||||||||||||
| Equity | ||||||||||||
| Issued capital | 883 | 762 | ||||||||||
| Capital reserves | 305,301 | 270,451 | ||||||||||
| Fair value reserves | 1,833 | 1,962 | ||||||||||
| Accumulated deficit | (261,001 | ) | (234,508 | ) | ||||||||
| Total equity | 7 | 47,016 | 38,667 | |||||||||
| Non-current liabilities | ||||||||||||
| Borrowings | 10 | 207 | 278 | |||||||||
| Contract liabilities | 15,203 | 37,961 | ||||||||||
| Lease liabilities | 332 | 272 | ||||||||||
| Total non-current liabilities | 15,742 | 38,511 | ||||||||||
| Current liabilities | ||||||||||||
| Trade and other payables | 8,123 | 10,674 | ||||||||||
| Provisions | 9 | 479 | 517 | |||||||||
| Borrowings | 10 | 1,070 | 2,105 | |||||||||
| Lease liabilities | 779 | 532 | ||||||||||
| Contract liabilities | 34,729 | 21,353 | ||||||||||
| Total current liabilities | 45,180 | 35,181 | ||||||||||
| TOTAL EQUITY AND LIABILITIES | 107,938 | 112,359 |
The Notes are an integral part of these consolidated financial statements.
Unaudited consolidated statements of cash flows (in thousands)
| For the nine months ended September 30 | ||||||||||
| Note | 2020 | 2019 | ||||||||
| Cash flow from operating activities | ||||||||||
| Loss for the period | (26,493 | ) | (19,372 | ) | ||||||
| Adjustments for the period: | ||||||||||
| - Income taxes | 0 | 4 | ||||||||
| - Depreciation and amortization | 821 | 648 | ||||||||
| - Net gain from disposal of leasehold improvements and equipment | 0 | (9 | ) | |||||||
| - Share based payments | 8 | 2,348 | 1,981 | |||||||
| - Finance income / costs net | 4 | 2,404 | (1,655 | ) | ||||||
| (20,920 | ) | (18,403 | ) | |||||||
| Change in trade and other receivables | (1,174 | ) | 458 | |||||||
| Change in inventories | (114 | ) | (70 | ) | ||||||
| Change in other assets | (1,087 | ) | (1,104 | ) | ||||||
| Change in trade, other payables, provisions and contract liabilities | (12,053 | ) | (11,727 | ) | ||||||
| Cash used in operating activities | (35,348 | ) | (30,846 | ) | ||||||
| Interest received | 299 | 413 | ||||||||
| Paid interest | (81 | ) | (180 | ) | ||||||
| Net cash used in operating activities | (35,130 | ) | (30,613 | ) | ||||||
| Cash flow from investing activities | ||||||||||
| Purchase of intangible assets | (8 | ) | (143 | ) | ||||||
| Purchase of leasehold improvements and equipment | (352 | ) | (926 | ) | ||||||
| Cash paid for investments in financial assets | (8,101 | ) | (39,733 | ) | ||||||
| Cash received from maturity of financial assets | 9,088 | 38,270 | ||||||||
| Net cash used for investing activities | 627 | (2,532 | ) | |||||||
| Cash flow from financing activities | ||||||||||
| Proceeds from issue of common shares | 33,846 | 26 | ||||||||
| Transaction costs related to issue of common shares | (1,134 | ) | 0 | |||||||
| Proceeds from borrowings | 0 | 562 | ||||||||
| Repayment of lease liabilities | (386 | ) | (299 | ) | ||||||
| Repayment of borrowings | 10 | (1,151 | ) | (2,339 | ) | |||||
| Cash flow from financing activities | 31,175 | (2,050 | ) | |||||||
| Exchange-rate related changes of cash and cash equivalents | (2,250 | ) | 361 | |||||||
| Net changes to cash and cash equivalents | (3,328 | ) | (35,195 | ) | ||||||
| Cash and cash equivalents at the beginning of the period | 95,234 | 94,829 | ||||||||
| Cash and cash equivalents at the end of the period | 89,656 | 59,995 |
The Notes are an integral part of these consolidated financial statements.
Unaudited consolidated statements of changes in equity (in thousands)
| Note | Issued capital | Capital reserves | Fair Value reserves | Accumulated deficit | Total equity | |||||||||||||||||||
| Balance as of January 1, 2019 | 624 | 239,055 | 2,594 | (202,144 | ) | 40,129 | ||||||||||||||||||
| Exercise of share based payment awards | 26 | 26 | ||||||||||||||||||||||
| Equity-settled share based payment awards | 8 | 1,981 | 1,981 | |||||||||||||||||||||
| Loss for the period | (19,372 | ) | (19,372 | ) | ||||||||||||||||||||
| Other comprehensive income | (531 | ) | (531 | ) | ||||||||||||||||||||
| Balance as of September 30, 2019 | 624 | 241,062 | 2,063 | (221,516 | ) | 22,233 | ||||||||||||||||||
| 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 | 8 | 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 |
The Notes are an integral part of these consolidated financial statements.
Affimed N.V. is a Dutch company with limited liability (naamloze vennootschap) and has its corporate seat in Amsterdam, the Netherlands. The 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, Affimed Inc., Delaware, USA and AbCheck Inc., Delaware, USA (together
Affimed , the Company or the Group ).
Affimed is a clinical-stage immuno-oncology company focused on discovering and
developing highly targeted cancer immunotherapies. The Group s product candidates represent 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, pursuant to which Affimed is performing research services for third parties.
Statement of compliance
The interim financial statements
for the three and nine months ended September 30, 2020 and 2019 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 annual
financial statements, and should be read in conjunction with Affimed N.V. s annual consolidated financial statements as of December 31, 2019.
The interim financial statements were authorized for issuance by the management board on November 10, 2020.
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, 2019.
Functional and presentation currency
These interim financial statements are presented in Euro, which is the Company s functional currency. 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 Company in these interim financial statements are the same as those applied by the Company in its consolidated financial
statements as of and for the year ended December 31, 2019 with the exception of new amendments to standards and new or amended interpretations applied for the first time as described below.
New standards and interpretations applied for the first time
The following amendments to standards and new or amended interpretations are effective for annual periods beginning on or after January 1, 2020, and have
been applied in preparing these financial statements:
| Standard/interpretation | Effective Date | |
| Amendments to References to the Conceptional Framework | January 1, 2020 | |
| Amendments to IAS 1 and IAS 8: Definition of Material | January 1, 2020 | |
| Amendments to IFRS 9, IAS 39 and IFRS 7: | ||
| Interest Rate Benchmark Reform | January 1, 2020 | |
| Amendments to IFRS 3 Business Combination | January 1, 2020 | |
| Amendment to IFRS 16 Leases Covid 19-Related Rent Concessions | June 1, 2020 |
None of the amendments to standards and new or amended interpretations had a material effect on the interim financial
Fair Value Measurement
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, 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 2 measurement procedures (see notes 5 and 10).
and interpretations not yet adopted
The following standards, amendments to standards and interpretations are effective for annual periods beginning
after December 31, 2019 and have not been applied in preparing these consolidated financial statements.
| Standard/interpretation | Effective Date | |||
| Amendments to IAS 1 Presentation of Financial Statements: | ||||
| Classification of Liabilities as Current or Non-current | January 1, 2023 | |||
| 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 IFRS 9, IAS 39, IFRS 7, IFRS 4 and | ||||
| IFRS 16 Interest Rate Benchmark Reform Phase 2 | January 1, 2021 |
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, 2020, the Company recognized
revenue totalling 0.1 million (2019: 0.0 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 will develop novel NK cell engager-based immunotherapeutics to treat multiple cancers. The Genentech agreement became effective at the beginning of October 2018. Affimed received $96.0 million ( 83.2 million) in initial
upfront and committed funding on October 31, 2018.
The Group recognized 10.5 million and 18.1 million as revenue during the
three and nine months ended September 30, 2020 (2019: 1.9 million and 16.2 million). As of September 30, 2020, contract liabilities of 49.9 million (December 31, 2019: 59.3 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.
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 Company recognized 0.0 million and 0.4 million as revenue in the three and nine months ended September 30, 2020 (2019: 0.2 million and 1.3 million).
The following table provides information about receivables and contract liabilities from contracts with customers.
| September 30, 2020 | December 31, 2019 | |||||||
| Receivables | 0 | 204 | ||||||
| Contract liabilities | 49,932 | 59,314 |
Amounts of 1,801 and 9,381 recognized in contract liabilities at the beginning of the period have been recognized
as revenue during the three and nine months ended September 30, 2020.
The remaining performance obligations as of September 30, 2020 are
approximately 49.9 million and are expected to be recognized as revenue to a large extent over the next two years.
Geographic information
| Three months ended September 30, 2020 | Three months ended September 30, 2019 | Nine months ended September 30, 2020 | Nine months ended September 30, 2019 | |||||||||||||
| Revenue: | ||||||||||||||||
| Germany | 0 | 0 | 75 | 0 | ||||||||||||
| Europe | 0 | 155 | 2 | 1,232 | ||||||||||||
| USA | 10,545 | 1,948 | 18,537 | 16,232 | ||||||||||||
| 10,545 | 2,103 | 18,614 | 17,464 |
| Three months ended September 30, 2020 | Three months ended September 30, 2019 | Nine months ended September 30, 2020 | Nine months ended September 30, 2019 | |||||||||||||
| Collaboration revenue | 10,539 | 1,948 | 18,255 | 16,232 | ||||||||||||
| Service revenue | 6 | 155 | 359 | 1,232 | ||||||||||||
| 10,545 | 2,103 | 18,614 | 17,464 |
Timing on revenue recognition
| Three months ended September 30, 2020 | Three months ended September 30, 2019 | Nine months ended September 30, 2020 | Nine months ended September 30, 2019 | |||||||||||||
| Point in time | 8,738 | 0 | 9,021 | 5,633 | ||||||||||||
| Over time | 1,807 | 2,103 | 9,593 | 11,831 | ||||||||||||
| 10,545 | 2,103 | 18,614 | 17,464 |
| Three months ended September 30, 2020 | Three months ended September 30, 2019 | Nine months ended September 30, 2020 | Nine months ended September 30, 2019 | |||||||||||||
| Interest SVB Loan Agreement | (34 | ) | (106 | ) | (150 | ) | (389 | ) | ||||||||
| Foreign exchange differences | (3,033 | ) | 1,425 | (2,478 | ) | 1,453 | ||||||||||
| Finance cost lease liability | (11 | ) | (5 | ) | (24 | ) | (18 | ) | ||||||||
| Other finance income/finance costs | 21 | 161 | 186 | 609 | ||||||||||||
| Gain from the modification of SVB Loan Agreement (see note 10) | 0 | 0 | 62 | 0 | ||||||||||||
| Finance income/costs - net | (3,057 | ) | 1,475 | (2,404 | ) | 1,655 |
The Company holds preferred shares in Amphivena recognized at their fair value of 3.1 million (December 31, 2019: 3.2 million). During the
three and nine months ended September 30, 2020, the fair value decreased by 139 and 129 (2019: 555 and 531) due to exchange rate differences.
As of September 30, 2020 and December 31, 2019, financial assets consisted of U.S. Dollar denominated certificates of deposit with original
maturities of more than three months.
As of September 30, 2020 the share capital of 883 (December 31, 2019: 762) is divided into 88,326,040 (December 31, 2019: 76,249,901) common
shares with a par value of 0.01 per share.
In May 2020, the Company implemented an
at-the-market ( ATM ) program providing for the sales over time of up to $50,000,000 of its common shares. As of September 30, 2020, the Company has
issued approximately 11.8 million common shares under this ATM program, generating net proceeds of approximately 32.4 million.
Annual General Meeting of Affimed N.V. held on August 4, 2020 the structure of the authorised share capital was changed as cumulative shares were abolished. As of September 30, 2020, authorised share capital of the company amounts to
3,120 and is divided into 311,950,000 shares, each with a nominal value of 0.01 per share. As at , December 31, 2019, the authorized share capital consisted of 155,975,000 common shares and 155,975,000 cumulative preference shares,
each with a par value of 0.01 per share.
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.
payments with service condition
The majority of the awards vest in instalments over three years and can be exercised up to 10 years after the grant
date. In the three and nine months ended September 30, 2020, the group granted 1,173,750 and 2,562,309 awards. 45,446 and 228,587 ESOP 2014 awards were cancelled or forfeited, and 42,598 and 239,605 options were exercised during the three and