Full Press Release Details
CONSOLIDATED FINANCIAL STATEMENTS
Unaudited consolidated statements
of comprehensive loss
| For the three months ended September 30 | For the nine months ended September 30 | |||||||||||||||||
| Note | 2017 | 2018 | 2017 | 2018 | ||||||||||||||
| Revenue | 3 | 467 | 306 | 1,374 | 988 | |||||||||||||
| Other income - net | 117 | (259 | ) | 201 | (221 | ) | ||||||||||||
| Research and development expenses | 8 | (6,008 | ) | (9,787 | ) | (16,881 | ) | (23,332 | ) | |||||||||
| General and administrative expenses | 8 | (1,876 | ) | (2,389 | ) | (6,091 | ) | (6,591 | ) | |||||||||
| Operating loss | (7,300 | ) | (12,129 | ) | (21,397 | ) | (29,156 | ) | ||||||||||
| Finance income / (costs) - net | 4 | (800 | ) | 109 | (2,425 | ) | 920 | |||||||||||
| Loss before tax | (8,100 | ) | (12,020 | ) | (23,822 | ) | (28,236 | ) | ||||||||||
| Income taxes | 0 | 0 | 20 | (1 | ) | |||||||||||||
| Loss for the period | (8,100 | ) | (12,020 | ) | (23,802 | ) | (28,237 | ) | ||||||||||
| Other comprehensive income Items that will not be reclassified to profit or loss Equity investments at fair value OCI - net change in fair value | 2 | 0 | 53 | 0 | 264 | |||||||||||||
| Other comprehensive income | 0 | 53 | 0 | 264 | ||||||||||||||
| Total comprehensive loss | (8,100 | ) | (11,967 | ) | (23,802 | ) | (27,973 | ) | ||||||||||
| Loss per share in per share (undiluted = diluted) | (0.18 | ) | (0.19 | ) | (0.55 | ) | (0.47 | ) |
The Notes are an integral part
of these consolidated financial statements.
Consolidated statements of
| Note | December 31, 2017 | September 30, 2018 | ||||||||
| (unaudited) | ||||||||||
| ASSETS | ||||||||||
| Non-current assets | ||||||||||
| Intangible assets | 65 | 63 | ||||||||
| Leasehold improvements and equipment | 1,113 | 1,271 | ||||||||
| Long term financial assets | 2, 5 | 0 | 7,589 | |||||||
| 1,178 | 8,923 | |||||||||
| Current assets | ||||||||||
| Inventories | 241 | 320 | ||||||||
| Trade and other receivables | 1,102 | 1,443 | ||||||||
| Other assets | 6 | 800 | 1,307 | |||||||
| Cash and cash equivalents | 39,837 | 37,076 | ||||||||
| 41,980 | 40,146 | |||||||||
| TOTAL ASSETS | 43,158 | 49,069 | ||||||||
| EQUITY AND LIABILITIES | ||||||||||
| Equity | ||||||||||
| Issued capital | 468 | 624 | ||||||||
| Capital reserves | 213,778 | 238,539 | ||||||||
| Other reserves | 0 | 7,589 | ||||||||
| Accumulated deficit | (182,667 | ) | (210,904 | ) | ||||||
| Total equity | 7 | 31,579 | 35,848 | |||||||
| Non current liabilities | ||||||||||
| Borrowings | 9 | 4,086 | 2,244 | |||||||
| Total non-current liabilities | 4,086 | 2,244 | ||||||||
| Current liabilities | ||||||||||
| Trade and other payables | 4,180 | 7,253 | ||||||||
| Borrowings | 9 | 3,083 | 3,083 | |||||||
| Contract liabilities | 230 | 641 | ||||||||
| Total current liabilities | 7,493 | 10,977 | ||||||||
| TOTAL EQUITY AND LIABILITIES | 43,158 | 49,069 |
Notes are an integral part of these consolidated financial statements.
Unaudited consolidated statements
| For the nine months ended September 30 | ||||||||||
| Note | 2017 | 2018 | ||||||||
| Cash flow from operating activities | ||||||||||
| Loss for the period | (23,802 | ) | (28,237 | ) | ||||||
| Adjustments for the period: | ||||||||||
| - Income taxes | (20 | ) | 1 | |||||||
| - Depreciation and amortisation | 257 | 303 | ||||||||
| - Gain from disposal of leasehold improvements and equipment | (20 | ) | 15 | |||||||
| - Share based payments | 8 | 1,494 | 1,523 | |||||||
| - Finance income / costs - net | 4 | 2,425 | (920 | ) | ||||||
| (19,666 | ) | (27,315 | ) | |||||||
| Change in trade and other receivables | 690 | (344 | ) | |||||||
| Change in inventories | (85 | ) | (79 | ) | ||||||
| Change in other assets | 6 | (393 | ) | (549 | ) | |||||
| Change in trade, other payables and contract liabilities | (1,044 | ) | 3,473 | |||||||
| Cash used in operating activities | (20,498 | ) | (24,814 | ) | ||||||
| Interest received | 48 | 159 | ||||||||
| Paid interest | (229 | ) | (268 | ) | ||||||
| Paid income tax | 0 | (1 | ) | |||||||
| Net cash used in operating activities | (20,679 | ) | (24,924 | ) | ||||||
| Cash flow from investing activities | ||||||||||
| Purchase of intangible assets | (26 | ) | (27 | ) | ||||||
| Purchase of leasehold improvements and equipment | (545 | ) | (448 | ) | ||||||
| Cash received from the sale of leasehold improvements and equipment | 35 | 1 | ||||||||
| Cash paid for investments in financial assets | (13,114 | ) | 0 | |||||||
| Cash received from maturity of financial assets | 13,425 | 0 | ||||||||
| Net cash used for investing activities | (225 | ) | (474 | ) | ||||||
| Cash flow from financing activities | ||||||||||
| Proceeds from issue of common shares | 7 | 19,241 | 25,110 | |||||||
| Transaction costs related to issue of common shares | (1,524 | ) | (1,702 | ) | ||||||
| Proceeds from borrowings | 2,500 | 0 | ||||||||
| Transaction costs related to borrowings | (11 | ) | 0 | |||||||
| Repayment of borrowings | 9 | 0 | (2,250 | ) | ||||||
| Cash flow from financing activities | 20,206 | 21,158 | ||||||||
| Exchange-rate related changes of cash and cash equivalents | (1,366 | ) | 1,479 | |||||||
| Net changes to cash and cash equivalents | (698 | ) | (4,240 | ) | ||||||
| Cash and cash equivalents at the beginning of the period | 35,407 | 39,837 | ||||||||
| Cash and cash equivalents at the end of the period | 33,343 | 37,076 |
The Notes are an integral part
of these consolidated financial statements.
Unaudited consolidated statements
of changes in equity
| Note | Issued capital | Capital reserves | Fair Value reserves | Accumulated deficit | Total equity | ||||||||||||||||
| Balance as of January 1, 2017 | 333 | 190,862 | 0 | (152,444 | ) | 38,751 | |||||||||||||||
| Issue of common shares | 114 | 17,199 | 17,313 | ||||||||||||||||||
| Equity-settled share based payment awards | 1,494 | 1,494 | |||||||||||||||||||
| Issue of warrant note (loan Silicon Valley Bank) | 51 | 51 | |||||||||||||||||||
| Loss for the period | (23,802 | ) | (23,802 | ) | |||||||||||||||||
| Balance as of September 30, 2017 | 447 | 209,606 | 0 | (176,246 | ) | 33,807 | |||||||||||||||
| Revaluation shares Amphivena (first time adoption IFRS 9) | 2, 5 | 7,325 | 7,325 | ||||||||||||||||||
| Balance as of January 1, 2018 | 468 | 213,778 | 7,325 | (182,667 | ) | 38,904 | |||||||||||||||
| Issue of common shares | 7 | 156 | 23,170 | 23,326 | |||||||||||||||||
| Exercise of share based payments awards | 8 | 68 | 68 | ||||||||||||||||||
| Equity-settled share based payment awards | 8 | 1,523 | 1,523 | ||||||||||||||||||
| Loss for the period | (28,237 | ) | (28,237 | ) | |||||||||||||||||
| Other comprehensive income | 2 | 264 | 264 | ||||||||||||||||||
| Balance as of September 30, 2018 | 624 | 238,539 | 7,589 | (210,904 | ) | 35,848 |
The Notes are an integral part
of these consolidated financial statements.
Notes to the 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, which was founded in July 2018 (together "Affimed"
Affimed is a clinical-stage biopharmaceutical
company focused on discovering and developing highly targeted cancer immunotherapies. The Company'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 and collaborations,
where the Company is performing research services for third parties.
Statement of compliance
The interim financial statements for the
three and nine months ended September 30, 2018 and 2017 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 at December 31, 2017.
The interim financial statements were authorized
for issuance by the management board on November 7, 2018.
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 at and for the year ended December 31, 2017.
As a result of the first-time adoption of
IFRS 9 at January 1, 2018 the Company recognized its preferred shares in Amphivena at fair value (level 2). As Amphivena is not
a public company substantial judgment was required in order to estimate the fair value as at January 1, 2018 and September 30,
2018 (see note 5). The Company based its judgment on information available for the valuation of the shares of Amphivena in its
latest private financing mid-year 2017 and the issuance of convertible notes in 2017 and 2018.
Notes to the consolidated financial statements
On April 20, 2018, Affimed issued 240,000
options under its share-based-payment program, the vesting of which deviates from the standard 3-year vesting scheme and depends
upon a market parameter, which is the average price of Affimed shares during a certain period of time as described in Note 8. Incorporating
the market condition in the fair value estimate requires the use of a simulation technique, which implies higher uncertainty with
regard to the estimated fair value. The Company determined the fair value of the awards at grant date to be $164 thousand (see
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 ), except per share amounts, which have not been rounded.
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
at and for the year ended December 31, 2017 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
The following amendments to standards and
new or amended interpretations are effective for annual periods beginning on or before January 1, 2018, and have been applied in
preparing these financial statements:
| Standard/interpretation | Effective Date 1 |
| IFRS 15 Revenue from Contracts with Customers | January 1, 2018 |
| IFRS 9 Financial Instruments (2014) | January 1, 2018 |
| Amendments to IFRS 2: Classification and Measurement of | |
| Share- based Payment Transactions | January 1, 2018 |
| Annual Improvements to IFRS Standards 2014-2016 Cycle (IFRS 1, IAS 28) | January 1, 2018 |
1 Shall apply for periods beginning
on or after the date shown in the effective date column.
The nature and effect of the application
of IFRS 9 and IFRS 15 are summarized below. The other amendments had no effect on the interim consolidated financial statements
IFRS 9 (Financial Instruments)
Changes in accounting policies resulting
from the adoption of IFRS 9 have been applied retrospectively with any differences in the carrying amounts arising from the transition
being recognized in equity as at January 1, 2018.
The standard contains a new classification
and measurement approach for financial instruments that
Notes to the consolidated financial statements
reflects the business model in which assets are managed and their cash
flow characteristics. Based on the new measurement requirements, Affimed recognized its shares in Amphivena at fair value, which
were previously recognized at amortized cost according to IAS 39. The transition effect increased other comprehensive income by
7.3 million as of January 1, 2018 (see note 5). The Company classified the shares as at fair value through other comprehensive
income (FVOCI). Future changes in fair value will be recognized in other comprehensive income, dividends will be recognized as
income in profit or loss.
Combined financial instruments are measured
at fair value with changes therein recognized as finance income / (costs) - net (see note 6).
The newly introduced impairment rules replace
the incurred loss' model in IAS 39 with a forward looking expected credit loss' ("ECL") model.
This requires considerable judgement as to how changes in economic factors affect ECLs, which will be determined on a probability-weighted
basis. Under IFRS 9, the Company has decided to measure loss allowances on the following basis:
Based on this methodology, incurred losses
on cash and cash equivalents and on trade and other receivables as of January 1, 2018 had no material impact on the consolidated
financial statements.
IFRS 15 (Revenue from contracts with customers)
IFRS 15 (Revenue from contracts with customers)
establishes a comprehensive framework for determining whether, how much and when revenue is recognized. It replaces existing revenue
recognition guidance, including IAS 18 Revenue, IAS 11 Construction Contracts and IFRIC 13 Customer Loyalty Programs.