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12-31 2021 Q2 false 2021-06-30 Exhibits 99.1 ​ AFFIMED N.V. UNAUDITED CONDENSED INTERIM CONSOLIDATED FINANCIAL STATEMENTS Unaudited interim consolidated statements of comprehensive income / (loss) (in € tho

Key Takeaway: 0001608390--12-312021Q2false2021-06-30 UNAUDITED CONDENSED INTERIM CONSOLIDATED FINANCIAL STATEMENTS Unaudited interim consolidated statements of comprehensive income / (loss) For the three months For the six months ended June 30 ended June 30 Note 2021 2020 202

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0001608390--12-312021Q2false2021-06-30
UNAUDITED CONDENSED INTERIM CONSOLIDATED FINANCIAL STATEMENTS
Unaudited interim consolidated statements of comprehensive income / (loss)
For the three months For the six months
ended June 30 ended June 30
Note 2021 2020 2021 2020
Revenue 3 9,707 2,934 21,366 8,069
Other income net 332 85 479 28
Research and development expenses ( 21,800 ) ( 11,697 ) ( 33,205 ) ( 23,146 )
General and administrative expenses ( 5,439 ) ( 2,606 ) ( 9,925 ) ( 6,131 )
Operating loss ( 17,200 ) ( 11,284 ) ( 21,285 ) ( 21,180 )
Finance income / (costs) net 4 ( 1,552 ) ( 954 ) 3,947 653
Loss before tax ( 18,752 ) ( 12,238 ) ( 17,338 ) ( 20,527 )
Income taxes 0 0 ( 2 ) 0
Loss for the period ( 18,752 ) ( 12,238 ) ( 17,340 ) ( 20,527 )
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 ( 4,097 ) ( 71 ) ( 5,349 ) 10
Other comprehensive income / (loss) ( 4,097 ) ( 71 ) ( 5,349 ) 10
Total comprehensive income / (loss) ( 22,849 ) ( 12,309 ) ( 22,689 ) ( 20,517 )
Earnings / (loss) per share in per share (undiluted = diluted) ( 0.16 ) ( 0.16 ) ( 0.15 ) ( 0.26 )
Weighted number of common shares outstanding 119,645,207 79,189,686 117,924,831 77,719,793
The Notes are an integral part of these condensed interim consolidated financial statements.
Unaudited interim consolidated statements of financial position
Note June 30, December 31,
2021 2020
(unaudited)
ASSETS
Non-current assets
Intangible assets 1,661 1,718
Leasehold improvements and equipment 3,447 2,226
Long term financial assets 5 14,693 20,042
Right-of-use assets 1,036 940
20,837 24,926
Current assets
Cash and cash equivalents 222,676 146,854
Trade and other receivables 6 3,763 2,439
Inventories 612 246
Other assets 7 135 1,260
227,186 150,799
TOTAL ASSETS 248,023 175,725
EQUITY AND LIABILITIES
Equity
Issued capital 1,197 983
Capital reserves 446,525 345,164
Fair value reserves ( 3,629 ) 1,720
Accumulated deficit ( 293,214 ) ( 275,874 )
Total equity 8 150,879 71,993
Non current liabilities
Borrowings 10 10,025 231
Contract liabilities 3 19,361 35,992
Lease liabilities 601 482
Total non-current liabilities 29,987 36,705
Current liabilities
Trade and other payables 15,838 11,394
Borrowings 10 93 92
Lease liabilities 523 492
Contract liabilities 3 50,703 55,049
Total current liabilities 67,157 67,027
TOTAL EQUITY AND LIABILITIES 248,023 175,725
The Notes are an integral part of these condensed interim consolidated financial statements.
Unaudited interim consolidated statements of cash flows
For the six months ended
June 30
Note 2021 2020
Cash flow from operating activities
Loss for the period ( 17,340 ) ( 20,527 )
Adjustments for the period:
- Income taxes 2 0
- Depreciation and amortisation 624 551
- Share based payments 9 4,695 1,410
- Finance income / costs net 4 ( 3,947 ) ( 653 )
( 15,966 ) ( 19,219 )
Change in trade and other receivables ( 1,324 ) ( 649 )
Change in inventories ( 366 ) ( 125 )
Change in other assets 924 0
Change in trade, other payables, provisions and contract liabilities ( 16,262 ) ( 11,757 )
Cash used in operating activities ( 32,994 ) ( 31,750 )
Interest received 0 276
Paid interest ( 377 ) ( 64 )
Paid income tax ( 2 ) 0
Net cash used in operating activities ( 33,373 ) ( 31,538 )
Cash flow from investing activities
Purchase of intangible assets ( 5 ) ( 2 )
Purchase of leasehold improvements and equipment ( 1,502 ) ( 174 )
Cash paid for investments in financial assets 0 ( 8,101 )
Cash received from maturity of financial assets 0 9,088
Net cash used for investing activities ( 1,507 ) 811
Cash flow from financing activities
Proceeds from issue of common shares, including exercise of share based payment awards 8 103,242 21,785
Transaction costs related to issue of common shares 8 ( 6,447 ) ( 754 )
Proceeds from borrowings 10 10,000 0
Transaction costs related to borrowings ( 236 ) 0
Repayment of lease liabilities ( 228 ) ( 257 )
Repayment of borrowings ( 46 ) ( 1,128 )
Cash flow from financing activities 106,285 19,646
Exchange-rate related changes of cash and cash equivalents 4,417 431
Net changes to cash and cash equivalents 71,405 ( 11,081 )
Cash and cash equivalents at the beginning of the period 146,854 95,234
Cash and cash equivalents at the end of the period 222,676 84,584
The Notes are an integral part of these condensed interim consolidated financial statements.
Unaudited interim consolidated statements of changes in equity
Issued Capital Fair Value Accumulated Total
Note capital reserves reserves deficit equity
Balance as of January 1, 2020 762 270,451 1,962 ( 234,508 ) 38,667
Issue of common shares 83 20,859 20,942
Equity-settled share based payment awards 9 1,410 1,410
Loss for the period ( 20,527 ) ( 20,527 )
Other comprehensive income 10 10
Balance as of June 30, 2020 845 292,720 1,972 ( 255,035 ) 40,502
Balance as of January 1, 2021 983 345,164 1,720 ( 275,874 ) 71,993
Issue of common shares 8 205 94,135 94,340
Exercise of share based payment awards 9 2,531 2,540
Equity-settled share based payment awards 9 4,695 4,695
Loss for the period ( 17,340 ) ( 17,340 )
Other comprehensive income ( 5,349 ) ( 5,349 )
Balance as of June 30, 2021 1,197 446,525 ( 3,629 ) ( 293,214 ) 150,879
The Notes are an integral part of these condensed interim 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 condensed interim 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 (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 interim consolidated financial statements (referred to as interim financial statements ) for the three and six months ended June 30, 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 September 8, 2021.
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, 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 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, 2020.
New standards and interpretations applied for the first time
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 IAS 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 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).
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 six months ended June 30, 2021, the Company did not recognize any revenue in this regard (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.
The Group recognized 3.6 million and 12.0 million as revenue during the three and six months ended June 30, 2021 (2020: 2.7 million and 7.6 million). As of June 30, 2021, the Group held contract liabilities of 29.9 million (December 31, 2020: 41.9 million), which 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. During the second quarter of 2021, Genentech Inc. has informed Affimed that the Phase 1 study of RO7297089 (anti-BCMA/CD16A) was discontinued. A portion of these potential milestone payments are associated with that molecule. This has no impact on the current contract liabilities and future revenue of 29.9 million.
Collaboration with Roivant Sciences Ltd.
On 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 milestone payments over time upon achievement of specified development, regulatory and commercial milestones, as well as tiered royalties on net sales.
For the three and six months ended June 30, 2021 the Group has recognized 5.9 million and 8.9 million as revenue and held 40.1 million under contract liabilities as of June 30, 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 0.2 million and 0.5 million as revenue in the three and six months ended June 30, 2021 (2020: 0.2 million and 0.4 million).
The following table provides information about receivables and contract liabilities from contracts with customers.
June 30, 2021 December 31, 2020
Receivables 393 0
Contract liabilities 70,064 91,041
Amounts of 9.5 million and 20.9 million recognized in contract liabilities at the beginning of the period have been recognized as revenue during the three and six months ended June 30, 2021, in respect of Genentech and Roivant.
The remaining performance obligations as of June 30, 2021 are approximately 70 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 Three months Six months Six months
ended ended ended ended
June 30, 2021 June 30, 2020 June 30, 2021 June 30, 2020
Revenue:
Germany 222 0 458 75
Europe 0 0 0 2
USA 9,485 2,934 20,908 7,992
9,707 2,934 21,366 8,069
Major service lines
Three months Three months Six months Six months
ended ended ended ended
June 30, 2021 June 30, 2020 June 30, 2021 June 30, 2020
Collaboration revenue 9,485 2,793 20,888 7,716
Service revenue 222 141 478 353
9,707 2,934 21,366 8,069
Timing on revenue recognition
Three months ended Three months ended Six months ended Six months ended
June 30, 2021 June 30, 2020 June 30, 2021 June 30, 2020
Point in time 120 106 180 283
Over time 9,587 2,828 21,186 7,786
9,707 2,934 21,366 8,069
4. Finance income and finance costs
Three months ended Three months ended Six months ended Six months ended
June 30, 2021 June 30, 2020 June 30, 2021 June 30, 2020
Interest SVB Loan Agreement ( 208 ) ( 59 ) ( 281 ) ( 116 )
Foreign exchange differences ( 1,209 ) ( 1,022 ) 4,413 554
Finance cost lease liability ( 13 ) ( 6 ) ( 25 ) ( 13 )
Other finance income/finance costs ( 122 ) 71 ( 160 ) 166
Gain from the modification of SVB Loan Agreement 0 62 0 62
Finance income/costs - net ( 1,552 ) ( 954 ) 3,947 653
5. Long term financial assets
The Group holds preferred shares in Amphivena recognized at their fair value of 3 million. During the six months ended June 30, 2021 the fair value increased by 0.1 million due to exchange rate differences recognized in other comprehensive income.
The Group also holds common shares in Roivant Sciences Ltd. at their fair value of 11.7 million. During the three and six months ended June 30, 2021 the fair value decreased by 4.0 million and 5.4 million, due to the implied value of the Roivant common shares as reflected in the proposed merger with Montes Archimedes Acquisition Corp, which was announced in May 2021. The decrease has been 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 the implied value of the Roivant common shares as reflected in the proposed merger with Montes Archimedes Acquisition Corp, as announced in May 2021 (level 3).
6. Trade and other receivables
Trade and other receivables mainly comprise Directors and Officers liability insurance prepayment of 0.9 million (December 31, 2020: 0 million) and value-added tax receivables of 1.6 million (December 31, 2020: 1.3 million).
The other assets as of June 30, 2021 of 0.1 million (December 31, 2020: 1.3 million) are short-term in nature, do not bear interest and are not impaired. These assets mainly comprise a deferred prepayment of 0.1 million in respect of a research project where certain milestone payments are due.
As of June 30, 2021 the share capital of 1,197 (December 31, 2020: 983) is divided into 119,731,915 (December 31, 2020: 98,287,333) common shares with a par value of 0.01 per share.
During the six months ended June 30, 2021, the Group issued approximately 1.2 million common shares under its ATM program, generating net proceeds of approximately 5.7 million. In connection with these common share issues an amount of 0.2 million of direct and incremental transaction costs were deducted from equity.
On January 15, 2021 the Group issued 19,166,667 common shares at a price of $6.00 per share in a public offering, resulting in net proceeds of approximately 88.7 million, incurring 6.1 million in underwriting commissions, legal and consulting expenses which were deducted from equity.
In April 2021 Silicon Valley Bank exercised all of its warrants and accordingly, the Group issued 173,482 common shares, refer note 10.
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, the Supervisory Board, non-employee consultants and employees.
Share based 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 six months ended June 30, 2021, the group granted 195,100 and 3,514,576 awards. 52,226 and 194,740 ESOP 2014 awards were cancelled or forfeited, and 605,353 and 947,275 options were exercised during the three and six months ended June 30, 2021. As of June 30, 2021, 10,415,902 ESOP 2014 options (December 31, 2020: 8,043,341) were outstanding, and 4,588,682 awards (December 31, 2020: 4,712,122) had vested. The options outstanding as of June 30, 2021 had an exercise price in the range of $1.30 to $13.47 and a weighted-average exercise price of $5.12.
Share based payment expense
In the three and six months ended June 30, 2021, compensation expense of 3,586 and 4,695 was recognized affecting research and development expenses ( 1,810 and 2,279) and general and administrative expenses ( 1,776 and 2,416). In the three and six months ended June 30, 2020, compensation expense of 684 and 1,410 was recognized affecting research and development expenses ( 400 and 717) and general and administrative expenses ( 284 and 693).
Fair value measurement
The fair value of options was determined using the Black-Scholes valuation model. The significant inputs into the valuation model of share based payment grants with service conditions are as follows (weighted average):
June 30, 2021 June 30, 2020
Fair value at grant date $ 6.78 $ 1.81
Share price at grant date $ 8.48 $ 2.50
Exercise price $ 8.48 $ 2.50
Expected volatility 95 % 91 %
Expected life 5.86 5.90
Expected dividends 0.00 0.00
Risk-free interest rate 1.12 % 1.30 %
Expected volatility is estimated based on the observed daily share price returns of Affimed measured over a historic period equal to the expected life of the awards.
The risk-free interest rates are based on the yield to maturity of U.S. Treasury strips (as best available indication for risk-free rates), for a term equal to the expected life, as measured as of the Grant Date.
On November 30, 2016, Affimed entered into a loan agreement with Silicon Valley Bank (the SVB loan ) for an initial tranche of 5.0 million and a second tranche drawn in May 2017 of 2.5 million. As of December 31, 2020, the loan was fully repaid.
Pursuant to the loan agreement of 2016, the Group also granted the lender warrants to purchase common shares of Affimed at the respective exercise price for a period of ten years from the date of grant. In April 2021 Silicon Valley Bank exercised its warrants and the Group issued 173,482 common shares to Silicon Valley Bank.
In January 2021, the Group entered into a new loan agreement with Silicon Valley Bank German Branch (SVB) which provides Affimed with up to 25 million in term loans in three tranches: 10 million available at closing, an additional 7.5 million upon the achievement of certain conditions, including milestones related to Affimed's pipeline and market capitalization, and a third tranche of 7.5 million upon the achievement of certain additional conditions related to Affimed's pipeline and liquidity. The first tranche of 10 million was drawn in February 2021. Pursuant to the terms of the agreement, the loans will bear interest at the greater of the European Central Bank Base Rate and 0%, plus 5.5%, and Affimed is entitled to make interest only payments through December 1, 2022, or June 1, 2023 if Affimed draws on the third tranche of the loans. The loans will mature at the end of November 2025. As of June 30, 2021, the fair value of the liability did not differ significantly from its carrying amount ( 9.8 million).
UniCredit Leasing CZ
In April 2019, the Group entered into a loan agreement with UniCredit Leasing CZ for 562. After an initial instalment of 127 in the second quarter of 2019, repayment is effected in monthly instalments of 8 until May 2024. As of June 30, 2021, an amount of 277 (December 31, 2020: 323) was outstanding, of which 93 was classified as current liabilities (December 31, 2020: 92). As of June 30, 2021, the fair value of the liability did not differ significantly from its carrying amount.
The supervisory directors of Affimed N.V. received compensation for their services on the supervisory board of 94 and 192 ( 96 and 181) in the three and six months ended June 30, 2021 (2020), remuneration of managing directors and other key management personnel amounted to 876 and 1,753 ( 593 and 1,198).
The Company recognized share-based payment expenses of 242 and 350 ( 17 and 53) for supervisory directors and 1,624 and 2,271 ( 361 and 721) for managing directors and other key management personnel in the three and six months ended June 30, 2021 (2020).
The following table provides the outstanding balances for management and supervisory board remuneration.
Outstanding balances
June 30, December 31,
2021 2020
Adi Hoess 0 2
Dr. Thomas Hecht 23 16
Ferdinand Verdonck 10 10
Dr. Ulrich Grau 13 14
Dr. Bernhard Ehmer 16 15
Uta Kemmerich-Keil 7 0
Harry Welten 12 8
Annalisa Jenkins 11 8
Mathieu Simon 9 7
Last updated: Sep 8, 2021