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Unaudited consolidated
statements of comprehensive income / (loss) (in thousand)
| Note | For the three months ended March 31 | |||||||||||
| 2020 | 2019 | |||||||||||
| Revenue | 3 | 5,135 | 11,353 | |||||||||
| Other income net | (57 | ) | 86 | |||||||||
| Research and development expenses | (11,449 | ) | (7,987 | ) | ||||||||
| General and administrative expenses | (3,525 | ) | (2,434 | ) | ||||||||
| Operating income / (loss) | (9,896 | ) | 1,018 | |||||||||
| Finance income / (costs) net | 4 | 1,607 | 834 | |||||||||
| Income / (loss) before tax | (8,289 | ) | 1,852 | |||||||||
| Income / (loss) for the period | (8,289 | ) | 1,852 | |||||||||
| 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 | 81 | 73 | |||||||||
| Other comprehensive income / (loss) | 81 | 73 | ||||||||||
| Total comprehensive income / (loss) | (8,208 | ) | 1,925 | |||||||||
| Earnings / (loss) per share in per share (undiluted = diluted) | (0.11 | ) | 0.03 | |||||||||
| Weighted number of common shares outstanding | 76,249,901 | 62,430,106 |
The notes are an integral part of these consolidated financial statements.
Consolidated statements of financial position (in thousand)
| Note | March 31, 2020 | December 31, 2019 | ||||||||||
| (unaudited) | ||||||||||||
| ASSETS | ||||||||||||
| Non-current assets | ||||||||||||
| Intangible assets | 121 | 137 | ||||||||||
| Leasehold improvements and equipment | 2,193 | 2,291 | ||||||||||
| Long term financial assets | 5 | 3,274 | 3,193 | |||||||||
| Right-of-use assets | 679 | 824 | ||||||||||
| 6,267 | 6,445 | |||||||||||
| Current assets | ||||||||||||
| Cash and cash equivalents | 82,765 | 95,234 | ||||||||||
| Financial assets | 6 | 5,476 | 8,902 | |||||||||
| Trade and other receivables | 2,171 | 1,482 | ||||||||||
| Inventories | 337 | 296 | ||||||||||
| 90,749 | 105,914 | |||||||||||
| TOTAL ASSETS | 97,016 | 112,359 | ||||||||||
| EQUITY AND LIABILITIES | ||||||||||||
| Equity | ||||||||||||
| Issued capital | 762 | 762 | ||||||||||
| Capital reserves | 271,178 | 270,451 | ||||||||||
| Fair value reserves | 2,043 | 1,962 | ||||||||||
| Accumulated deficit | (242,797 | ) | (234,508 | ) | ||||||||
| Total equity | 7 | 31,186 | 38,667 | |||||||||
| Non-current liabilities | ||||||||||||
| Borrowings | 10 | 254 | 278 | |||||||||
| Contract liabilities | 30,430 | 37,961 | ||||||||||
| Lease liabilities | 155 | 272 | ||||||||||
| Total non-current liabilities | 30,839 | 38,511 | ||||||||||
| Current liabilities | ||||||||||||
| Trade and other payables | 8,434 | 10,674 | ||||||||||
| Provisions | 9 | 497 | 517 | |||||||||
| Borrowings | 10 | 1,401 | 2,105 | |||||||||
| Lease liabilities | 522 | 532 | ||||||||||
| Contract liabilities | 24,137 | 21,353 | ||||||||||
| Total current liabilities | 34,991 | 35,181 | ||||||||||
| TOTAL EQUITY AND LIABILITIES | 97,016 | 112,359 |
The notes are an integral part of these consolidated financial statements.
Unaudited consolidated statements of cash flows (in thousand)
| For the three months ended March 31 | ||||||||||||
| Note | 2020 | 2019 | ||||||||||
| Cash flow from operating activities | ||||||||||||
| Income / (loss) for the period | (8,289 | ) | 1,852 | |||||||||
| Adjustments for the period: | ||||||||||||
| - Depreciation and amortization | 280 | 210 | ||||||||||
| - Net gain from disposal of leasehold improvements and equipment | 0 | (9 | ) | |||||||||
| - Share based payments | 8 | 727 | 601 | |||||||||
| - Finance income / costs net | 4 | (1,607 | ) | (834 | ) | |||||||
| (8,889 | ) | 1,820 | ||||||||||
| Change in trade and other receivables | (750 | ) | (6,688 | ) | ||||||||
| Change in inventories | (41 | ) | (65 | ) | ||||||||
| Change in other assets | 0 | (183 | ) | |||||||||
| Change in trade, other payables, provisions and contract liabilities | (6,999 | ) | (8,252 | ) | ||||||||
| Cash used in operating activities | (16,679 | ) | (13,368 | ) | ||||||||
| Interest received | 160 | 62 | ||||||||||
| Paid interest | (28 | ) | (77 | ) | ||||||||
| Net cash used in operating activities | (16,547 | ) | (13,383 | ) | ||||||||
| Cash flow from investing activities | ||||||||||||
| Purchase of intangible assets | (2 | ) | (64 | ) | ||||||||
| Purchase of leasehold improvements and equipment | (20 | ) | (66 | ) | ||||||||
| Cash paid for investments in financial assets | 0 | (21,061 | ) | |||||||||
| Cash received from maturity of financial assets | 3,736 | 3,513 | ||||||||||
| Net cash used for investing activities | 3,714 | (17,678 | ) | |||||||||
| Cash flow from financing activities | ||||||||||||
| Repayment of lease liabilities | (128 | ) | (82 | ) | ||||||||
| Repayment of borrowings | 10 | (773 | ) | (833 | ) | |||||||
| Cash flow from financing activities | (901 | ) | (915 | ) | ||||||||
| Exchange-rate related changes of cash and cash equivalents | 1,265 | 236 | ||||||||||
| Net changes to cash and cash equivalents | (13,734 | ) | (31,976 | ) | ||||||||
| Cash and cash equivalents at the beginning of the period | 95,234 | 94,829 | ||||||||||
| Cash and cash equivalents at the end of the period | 82,765 | 63,089 |
The notes are an integral part of these consolidated 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, 2019 | 624 | 239,055 | 2,594 | (202.144 | ) | 40,129 | ||||||||||||||||
| Equity-settled share based payment awards | 8 | 601 | 601 | |||||||||||||||||||
| Income for the period | 1,852 | 1,852 | ||||||||||||||||||||
| Other comprehensive income | 73 | 73 | ||||||||||||||||||||
| Balance as of March 31, 2019 | 624 | 239,656 | 2,667 | (200,292 | ) | 42,655 | ||||||||||||||||
| Balance as of January 1, 2020 | 762 | 270,451 | 1,962 | (234,508 | ) | 38,667 | ||||||||||||||||
| Equity-settled share based payment awards | 8 | 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 |
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 months
ended March 31, 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 June 23, 2020.
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, 2019.
Functional and presentation currency
These interim financial statements are presented in Euro, which is the functional currency of all consolidated entities. 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 |
None of the amendments to standards and new or amended interpretations had a material effect on the interim financial statements.
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,
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).
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 three months ended March 31, 2020, the Company recognized revenue
totalling 0.1 million (2019: 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 4.8 million and
10.6 million as revenue during the three months ended March 31, 2020 and 2019, respectively. As of March 31, 2020, contract liabilities of
54.5 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 0.2 million as
revenue in the three months ended March 31, 2020 (2019: 0.7 million).
following table provides information about receivables and contract liabilities from contracts with customers.
| March 31, 2020 | December 31, 2019 | |||||||
| Receivables | 146 | 204 | ||||||
| Contract liabilities | 54,567 | 59,314 |
An amount of 4,952 recognized in contract liabilities at the beginning of the
period has been recognized as revenue during the three months ended March 31, 2020.
The remaining performance obligations as of March 31, 2020 are
approximately 54.6 million and are expected to be recognized as revenue to a large extent over the next two years.
Disaggregation of revenue
| Three months ended March 31, 2020 | Three months ended March 31, 2019 | |||||||
| Revenue: | ||||||||
| Germany | 75 | 0 | ||||||
| Europe | 2 | 752 | ||||||
| USA | 5,058 | 10,601 | ||||||
| 5,135 | 11,353 |
| Three months ended March 31, 2020 | Three months ended March 31, 2019 | |||||||
| Collaboration revenue | 4,923 | 10,601 | ||||||
| Service revenue | 212 | 752 | ||||||
| 5,135 | 11,353 |
Timing on revenue recognition
| Three months ended March 31, 2020 | Three months ended March 31, 2019 | |||||||
| Point in time | 177 | 5,633 | ||||||
| Over time | 4,958 | 5,720 | ||||||
| 5,135 | 11,353 |
| Three months ended March 31, 2020 | Three months ended March 31, 2019 | |||||||
| Interest SVB Loan Agreement | (57) | (155) | ||||||
| Foreign exchange differences | 1,576 | 756 | ||||||
| Finance cost lease liability | (7) | (6) | ||||||
| Other finance income/finance costs | 95 | 239 | ||||||
| Finance income/costs - net | 1,607 | 834 |
The Company holds preferred shares in Amphivena recognized at their fair value of 3.3 million. As of
March 31, 2020 the fair value increased by 0.1 million due to exchange rate differences recognized in other comprehensive income (2019:
As of March 31, 2020 and December 31, 2019, financial assets consisted of U.S. Dollar denominated certificates of deposit with original maturities of more
of March 31, 2020 the share capital of 762 (December 31, 2019: 762) is divided into 76,249,901 (December 31, 2019: 76,249,901) common
shares 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.
Share based payments with service
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
909,809 awards in the three months ended March 31, 2020 to employees. 124,412 ESOP 2014 awards were cancelled or forfeited and no options were exercised. As of March 31, 2020, 8,092,964 (December 31, 2019: 7,307,567) ESOP 2014 options were
outstanding, and 5,366,419 awards (December 31, 2019: 4,773,840) had vested. The options outstanding as of March 31, 2020 had an exercise price in the range of $1.30 to $13.47.
Share based payments with market condition
On April 20, 2018, Affimed
issued 240,000 options, of which each grant consists of three tranches that vest when the volume-weighted average share price (measured based on Affimed closing share prices over the preceding fifteen trading days) reaches a certain hurdle
($6.15, $8.20 and $10.25). Fair value of the awards at grant date amounts to 133 ($164 thousand) and the contractual life time of the options is two years. As of March 31, 2020 no
options were exercisable.
Share based payment expense