Exhibit 99.1
AFFIMED N.V.
Unaudited consolidated interim statements of comprehensive income / (loss)
(in € thousand)
For the three months | For the six months | |||||||||
ended June 30 | ended June 30 | |||||||||
| Note |
| 2022 |
| 2021 |
| 2022 |
| 2021 | |
Revenue | 3 | | | | | |||||
Other income – net |
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Research and development expenses |
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General and administrative expenses |
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Operating loss |
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Finance income / (costs) – net |
| 4 |
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Loss before tax |
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Income taxes |
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Loss for the period |
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Other comprehensive income / (loss) |
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Items that will not be reclassified to profit or loss |
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Equity investments at fair value OCI – net change in fair value |
| 5 |
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Other comprehensive income / (loss) |
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Total comprehensive income / (loss) |
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Basic and diluted earnings / (loss) per share in € per share (undiluted = diluted) |
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Weighted number of common shares outstanding |
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The notes are an integral part of these condensed consolidated interim financial statements.
Consolidated interim statements of financial position
(in € thousand)
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| June 30, |
| December 31, | ||
Note | 2022 | 2021 | ||||
(unaudited) | ||||||
ASSETS |
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Non-current assets |
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Intangible assets |
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Leasehold improvements and equipment |
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Long-term financial assets |
| 6 |
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Right-of-use assets |
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Current assets | ||||||
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Cash and cash equivalents |
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Trade and other receivables |
| 7 |
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Inventories |
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Assets held for sale | 5 | | | |||
Other assets and prepaid expenses |
| 8 |
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TOTAL ASSETS |
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EQUITY AND LIABILITIES |
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Equity |
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Issued capital |
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Capital reserves |
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Fair value reserves |
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Accumulated deficit |
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Total equity |
| 9 |
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Non current liabilities |
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Borrowings |
| 11 |
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Contract liabilities |
| 3 |
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Lease liabilities |
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Total non-current liabilities |
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Current liabilities |
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Trade and other payables |
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Borrowings |
| 11 |
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Lease liabilities |
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Contract liabilities |
| 3 |
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Total current liabilities |
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TOTAL EQUITY AND LIABILITIES |
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The notes are an integral part of these condensed consolidated interim financial statements.
Unaudited consolidated interim statements of cash flows
(in € thousand)
For the six months ended | ||||||
June 30 | ||||||
| Note |
| 2022 | 2021 | ||
Cash flow from operating activities |
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Income / (loss) for the period |
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Adjustments for the period: |
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- Income taxes |
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- Depreciation and amortization |
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- Share-based payments |
| 10 |
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- Finance income / costs – net |
| 4 |
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Change in trade and other receivables |
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Change in inventories |
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Change in other assets and prepaid expenses |
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Change in trade, other payables, provisions and contract liabilities |
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Interest received |
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Paid interest |
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Paid income tax | ( | ( | ||||
Net cash used in operating activities |
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Cash flow from investing activities |
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Purchase of intangible assets |
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Purchase of leasehold improvements and equipment |
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Cash received from the sale of financial assets |
| 5 |
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Net cash used for / generated from investing activities |
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Cash flow from financing activities |
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Proceeds from issue of common shares, including exercise of share-based payment awards |
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Transaction costs related to issue of common shares |
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Proceeds from borrowings |
| 11 |
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Transaction costs related to borrowings | | ( | ||||
Repayment of lease liabilities |
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Repayment of borrowings |
| 11 |
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Cash flow from financing activities |
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Exchange-rate related changes of cash and cash equivalents |
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Net changes to cash and cash equivalents |
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Cash and cash equivalents at the beginning of the period |
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Cash and cash equivalents at the end of the period |
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The notes are an integral part of these condensed consolidated interim financial statements.
Unaudited consolidated interim statements of changes in equity
(in € thousand)
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| Issued |
| Capital |
| Fair Value |
| Accumulated |
| Total | ||
Note | capital | reserves | reserves | deficit | equity | |||||||
Balance as of January 1, 2021 |
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Issue of common shares |
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Exercise of share-based payment awards |
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Equity-settled share-based payment awards | | | ||||||||||
Loss for the period |
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Other comprehensive loss |
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Balance as of June 30, 2021 |
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Balance as of January 1, 2022 |
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Issue of common shares |
| 9 |
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Exercise of share-based payment awards | | | ||||||||||
Equity-settled share-based payment awards |
| 10 |
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Transfer of cumulative loss on sale of financial assets | 5 | | ( | | ||||||||
Loss for the period |
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Other comprehensive loss |
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Balance as of June 30, 2022 |
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The notes are an integral part of these condensed consolidated interim financial statements.
1. Reporting entity
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 “interim financial statements”) for the three and six months ended June 30, 2022 and 2021 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, 2021.
The interim financial statements were authorized for issuance by the management board of the Company (Management Board) on August 11, 2022.
Loss per share
Loss per common share is calculated by dividing the loss for the period by the weighted average number of common shares outstanding during the period.
As of June 30, 2022, the Group has granted
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, 2021.
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, 2021.
New standards and amendments to standards
The following new standards and amendments to standards have not been applied in preparing these interim financial statements.
Standard/interpretation |
| Effective Date1 |
Amendments to IAS 1 Presentation of Financial Statements: | ||
1 Shall apply for periods beginning on or after the date shown in the effective date column.
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:
● | Level 1 – Prices for identical assets or liabilities quoted in active markets (non-adjusted); |
● | Level 2 – Measurement procedures, in which the lowest level input parameter significant on the whole for fair value measurement is directly or indirectly observable for on the market; and |
● | Level 3 – Measurement procedures, in which the lowest level input parameter significant on the whole for fair value measurement is not directly or indirectly observable for on the market. |
The carrying amount of all trade and other receivables, other assets and prepaid expenses, certificates of deposit, 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 been disclosed. 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 and 6). The Group recognises transfers between levels of the fair value hierarchy as at the date at which the change has occurred.
3. Revenue
Collaboration with Genentech Inc.
In August 2018, 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 $
The Group recognized €
Under the terms of the agreement, Affimed is eligible to receive up to an additional $
Collaboration with Roivant Sciences Ltd.
On November 9, 2020, Affimed and 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 $
The Group recognized €
Research service agreements
The Group 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 €
Contract balances
The following table provides information about receivables and contract liabilities from contracts with customers.
| June 30, 2022 |
| December 31, 2021 | |
Receivables |
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Contract liabilities |
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An amount of €
Disaggregation of revenue
Three months | Three months | Six months | Six months | |||||
ended | ended | ended | ended | |||||
| June 30, 2022 |
| June 30, 2021 |
| June 30, 2022 |
| June 30, 2021 | |
Geographic information | ||||||||
Revenue: |
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Germany |
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USA |
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Three months | Three months | Six months | Six months | |||||
ended | ended | ended | ended | |||||
| June 30, 2022 |
| June 30, 2021 |
| June 30, 2022 |
| June 30, 2021 | |
Major service lines: |
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Collaboration revenue |
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Service revenue |
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Three months ended |
| Three months ended |
| Six months ended |
| Six months ended | ||
| June 30, 2022 |
| June 30, 2021 |
| June 30, 2022 |
| June 30, 2021 | |
Timing on revenue recognition: | ||||||||
Point in time |
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Over time |
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4. Finance income and finance costs
Three months ended | Three months ended | Six months ended | Six months ended | |||||
| June 30, 2022 |
| June 30, 2021 |
| June 30, 2022 |
| June 30, 2021 | |
Interest SVB Loan Agreement |
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Foreign exchange differences |
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Other finance income/finance costs - net |
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5. Assets held for sale
The Group holds common shares in Roivant and made a strategic decision in June 2022 to dispose of this investment in tranches within the next 12 months. During the three months ended June 30, 2022, Affimed sold
6. Long- term financial assets
The Group holds preferred shares in Amphivena, which are currently recognized at their fair value of
As of December 31, 2021, the long-term financial assets included the Group’s investment in Roivant at its fair value of €
7. Trade and other receivables
The trade receivables as of June 30, 2022 were €
8. Other assets and prepaid expenses
The other assets and prepaid expenses as of June 30, 2022 of €
9. Equity
As of June 30, 2022, the share capital of €
In November 2021, the Company entered into an agreement for a new at-the-market (“ATM”) program providing for the sales over time of up to $
On April 18, 2022, the Company closed its public offering of
10. 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 of the Company (Supervisory Board), non-employee consultants and employees.
Share-based payments with service condition
The majority of the awards vest in instalments over
Share-based payments with market condition
During the three and six months ended June 30, 2022, the Company issued
Share-based payment expense
In the three and six months ended June 30, 2022, compensation expense of €
Fair value measurement
The fair value of options with service conditions was determined using the Black-Scholes-Merton valuation model. The significant inputs into the valuation model are as follows (weighted average):
| June 30, 2022 |
| June 30, 2021 | ||||
Fair value at grant date | $ | | $ | | |||
Share price at grant date | $ | | $ | | |||
Exercise price | $ | | $ | | |||
Expected volatility |
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Expected life |
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Expected dividends |
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Risk-free interest rate |
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The fair value of options with market conditions was determined using a Monte Carlo simulation. The significant inputs into the valuation model are as follows (weighted average):
| June 30, 2022 |
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Fair value at grant date | $ | | ||
Share price at grant date | $ | | ||
Exercise price | $ | | ||
Expected volatility |
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Expected life |
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Expected dividends |
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Risk-free interest rate |
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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.
11. Borrowings
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 €
The loan is secured by a pledge of
UniCredit Leasing CZ
In April 2019, the Group entered into a loan agreement with UniCredit Leasing CZ for €
12. Related parties
The supervisory directors of Affimed N.V. received compensation for their services on the Supervisory Board of €
The Company recognized share-based payment expenses of €
The following table provides the total amounts of outstanding balances for supervisory board compensation and expense reimbursement related to key management personnel:
Outstanding balances | ||||
June 30, | December 31, | |||
| 2022 |
| 2021 | |
Adi Hoess |
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Thomas Hecht |
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Mathieu Simon |
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Ferdinand Verdonck 1 |
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Ulrich Grau |
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Bernhard Ehmer | | |||
Harry Welten | | | ||
Annalisa Jenkins | | | ||
Uta Kemmerich-Keil |
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1 Mr. Verdonck left the Supervisory Board in June 2021.
13. Subsequent events
Subsequent to June 30, 2022 and through August 5, 2022, an additional