Full Press Release Details
Condensed Consolidated Financial Statements
| Unaudited condensed consolidated statement of comprehensive income / (loss) | 2 |
| Condensed consolidated statement of financial position | 3 |
| Unaudited condensed consolidated statement of cash flows | 4 |
| Unaudited condensed consolidated statement of changes in equity | 5 |
| Notes to the consolidated financial statements | 6 |
UNAUDITED CONDENSED CONSOLIDATED STATEMENT OF COMPREHENSIVE LOSS
| For the three months ended September 30 | For the nine months ended September 30 | |||||||||||||||||||
| Note | 2015 | 2016 | 2015 | 2016 | ||||||||||||||||
| (in thousand) | ||||||||||||||||||||
| Revenue | 3 | 1,155 | 938 | 5,903 | 4,943 | |||||||||||||||
| Other income - net | 4 | 298 | 19 | 631 | 143 | |||||||||||||||
| Research and development expenses | 8 | (6,448 | ) | (8,760 | ) | (14,974 | ) | (24,456 | ) | |||||||||||
| General and administrative expenses | 8 | (2,068 | ) | (2,181 | ) | (5,592 | ) | (6,239 | ) | |||||||||||
| Operating (loss) | (7,063 | ) | (9,984 | ) | (14,032 | ) | (25,609 | ) | ||||||||||||
| Finance income / (costs) - net | 5 | (193 | ) | (311 | ) | 108 | (1,183 | ) | ||||||||||||
| Loss before tax | (7,256 | ) | (10,295 | ) | (13,924 | ) | (26,792 | ) | ||||||||||||
| Income taxes | (36 | ) | 0 | (36 | ) | (2 | ) | |||||||||||||
| Loss for the period | (7,292 | ) | (10,295 | ) | (13,960 | ) | (26,794 | ) | ||||||||||||
| Total comprehensive loss | (7,292 | ) | (10,295 | ) | (13,960 | ) | (26,794 | ) | ||||||||||||
| Loss per share in per share (undiluted = diluted) | (0.24 | ) | (0.31 | ) | (0.52 | ) | (0.81 | ) |
The Notes are an integral part of these consolidated financial
CONDENSED CONSOLIDATED STATEMENT OF FINANCIAL POSITION
| Note | December 31, 2015 | September 30, 2016 | ||||||||||
| (unaudited) | ||||||||||||
| (in thousand) | ||||||||||||
| ASSETS | ||||||||||||
| Non-current assets | ||||||||||||
| Intangible assets | 72 | 64 | ||||||||||
| Leasehold improvements and equipment | 915 | 845 | ||||||||||
| 987 | 909 | |||||||||||
| Current assets | ||||||||||||
| Inventories | 228 | 253 | ||||||||||
| Trade and other receivables | 915 | 2,337 | ||||||||||
| Other assets | 6 | 452 | 603 | |||||||||
| Financial assets | 7 | 0 | 13,440 | |||||||||
| Cash and cash equivalents | 76,740 | 35,693 | ||||||||||
| 78,335 | 52,326 | |||||||||||
| TOTAL ASSETS | 79,322 | 53,235 | ||||||||||
| EQUITY AND LIABILITIES | ||||||||||||
| Equity | ||||||||||||
| Issued capital | 333 | 333 | ||||||||||
| Capital reserves | 187,169 | 189,888 | ||||||||||
| Accumulated deficit | (120,228 | ) | (147,022 | ) | ||||||||
| Total equity | 67,274 | 43,199 | ||||||||||
| Non current liabilities | ||||||||||||
| Borrowings | 9 | 3,104 | 1,685 | |||||||||
| Total non-current liabilities | 3,104 | 1,685 | ||||||||||
| Current liabilities | ||||||||||||
| Trade and other payables | 4,444 | 6,327 | ||||||||||
| Borrowings | 9 | 1,472 | 1,959 | |||||||||
| Deferred revenue | 3 | 3,028 | 65 | |||||||||
| Total current liabilities | 8,944 | 8,351 | ||||||||||
| TOTAL EQUITY AND LIABILITIES | 79,322 | 53,235 |
The Notes are an integral part of these consolidated financial
UNAUDITED CONDENSED CONSOLIDATED STATEMENT OF CASH FLOWS
| For the nine months ended September 30 | ||||||||||||
| Note | 2015 | 2016 | ||||||||||
| (in thousand) | ||||||||||||
| Cash flow from operating activities | ||||||||||||
| Loss for the period | (13,960 | ) | (26,794 | ) | ||||||||
| Adjustments for the period: | ||||||||||||
| Income taxes | 36 | 2 | ||||||||||
| Depreciation and amortisation | 240 | 293 | ||||||||||
| Share based payments | 8 | 1,453 | 2,719 | |||||||||
| Finance income / costs - net | 5 | (108 | ) | 1,183 | ||||||||
| (12,339 | ) | (22,597 | ) | |||||||||
| Change in trade and other receivables | (508 | ) | (1,398 | ) | ||||||||
| Change in inventories | (40 | ) | (25 | ) | ||||||||
| Change in other assets | 6 | 0 | (151 | ) | ||||||||
| Change in trade, other payables and deferred revenue | (1,218 | ) | (1,080 | ) | ||||||||
| Cash used in operating activities | (14,105 | ) | (25,251 | ) | ||||||||
| Interest received | 5 | 60 | ||||||||||
| Paid interest | (426 | ) | (355 | ) | ||||||||
| Net cash used in operating activities | (14,526 | ) | (25,546 | ) | ||||||||
| Cash flow from investing activities | ||||||||||||
| Purchase of intangible assets | (10 | ) | (21 | ) | ||||||||
| Purchase of leasehold improvements and equipment | (204 | ) | (194 | ) | ||||||||
| Cash paid for investments in financial assets | 7 | 0 | (27,088 | ) | ||||||||
| Cash received from maturity of financial assets | 0 | 13,536 | ||||||||||
| Net cash used for investing activities | (214 | ) | (13,767 | ) | ||||||||
| Cash flow from financing activities | ||||||||||||
| Proceeds from issue of common shares | 37,524 | 0 | ||||||||||
| Transactions costs related to issue of common shares | (3,090 | ) | 0 | |||||||||
| Repayment of borrowings | 9 | 0 | (1,079 | ) | ||||||||
| Cash flow from financing activities | 34,434 | (1,079 | ) | |||||||||
| Net changes to cash and cash equivalents | 19,694 | (40,392 | ) | |||||||||
| Cash and cash equivalents at the beginning of the period | 39,725 | 76,740 | ||||||||||
| Exchange-rate related changes of cash and cash equivalents | 1,006 | (655 | ) | |||||||||
| Cash and cash equivalents at the end of the period | 60,425 | 35,693 |
The Notes are an integral part of these consolidated financial
UNAUDITED CONDENSED CONSOLIDATED STATEMENT OF CHANGES IN EQUITY
| Note | Issued capital | Capital reserves | Accumulated deficit | Total equity | ||||||||||||||
| (in thousand) | ||||||||||||||||||
| Balance as of January 1, 2015 | 240 | 131,544 | (99,989 | ) | 31,795 | |||||||||||||
| Issue of common shares | 57 | 33,433 | 33,490 | |||||||||||||||
| Exercise of share based payment awards | 2 | 942 | 944 | |||||||||||||||
| Equity-settled share based payment awards | 8 | 1,453 | 1,453 | |||||||||||||||
| Loss for the period | (13,960 | ) | (13,960) | |||||||||||||||
| Balance as of September 30, 2015 | 299 | 167,372 | (113,949 | ) | 53,722 | |||||||||||||
| Balance as of January 1, 2016 | 333 | 187,169 | (120,228 | ) | 67,274 | |||||||||||||
| Equity-settled share based payment awards | 8 | 2,719 | 2,719 | |||||||||||||||
| Loss for the period | (26,794 | ) | (26,794) | |||||||||||||||
| Balance as of September 30, 2016 | 333 | 189,888 | (147,022 | ) | 43,199 |
The Notes are an integral part of these consolidated financial
Notes to the consolidated financial statements
Affimed N.V. (in the following Affimed or Company) is a Dutch
company with limited liability (naamloze vennootschap) and has its corporate seat in Amsterdam, the Netherlands.
The condensed consolidated financial statements of Affimed as
of and for the period ended September 30, 2016 comprise the Company and its wholly owned and controlled subsidiaries Affimed GmbH,
Heidelberg, Germany (formerly Affimed Therapeutics AG), AbCheck s.r.o., Plzen, Czech Republic and Affimed Inc., Delaware, USA.
Affimed is a clinical-stage biopharmaceutical group focused
on discovering and developing targeted cancer immunotherapies. The Company's product candidates are developed in the field
of immuno-oncology, which represents an innovative approach to cancer research that seeks to harness the body's own immune
system 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, 2016 and 2015 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, 2015.
The interim financial statements were authorized for issuance
by the management board on November 2, 2016.
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 Group's accounting policies were the same as those that applied to the consolidated
financial statements as at and for the year ended December 31, 2015.
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 Group in these interim
financial statements are the same as those applied by the Group in its consolidated financial statements as at and for the year
ended December 31, 2015 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
A number of amendments to standards and new or amended interpretations
are effective for annual periods beginning on or before January 1, 2016, and have been applied in preparing these financial statements.
Notes to the consolidated financial statements
| Standard/interpretation | Effective Date(1) |
| Annual Improvements to IFRSs 2012-2014 Cycle | January 1, 2016 |
| Amendments to IAS 16, 38 Clarification of acceptable methods of depreciation and amortization | January 1, 2016 |
| Amendments to IAS 1 Disclosure Initiative | January 1, 2016 |
| Amendments to IFRS 10, 12 and IAS 28 Investment Entities | January 1, 2016 |
| Amendment to IFRS 11 Accounting for Acquisitions of Interests in Joint Operations | January 1, 2016 |
None of these amendments to standards and new or amended interpretations
had an effect on the interim consolidated financial statements of the Group.
New standards and interpretations not yet adopted
The following standards, amendments to standards and interpretations
are effective for annual periods beginning after December 31, 2016, and have not been applied in preparing these consolidated financial
| 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 IAS 7 Disclosure Initiative | January 1, 2017 |
| IFRS 16 Leases | January 1, 2019 |
| Clarifications to IFRS 15 Revenue from Contracts with Customers | January 1, 2018 |
| Amendments to IFRS 2: Classification and Measurement of Share- based Payment Transactions | January 1, 2018 |
The Company has not yet determined if any of these amendments
to standards and new or amended interpretations will have an effect on its financial statements.
Collaboration agreement Amphivena
Affimed was party to a collaboration with Amphivena Therapeutics
Inc., San Francisco, USA (in the following Amphivena). The purpose of the collaboration was the development of a product candidate
for hematological malignancies. The collaboration included a License and Development Agreement between Amphivena and Affimed, which
expired when Amphivena obtained the approval of an investigational new drug application (IND) from the FDA in July 2016.
Pursuant to the license and development agreement between Affimed
and Amphivena, Affimed granted a license to intellectual property and agreed to perform certain services for Amphivena related
to the development of a product candidate for hematological malignancies. In consideration for the research and development work
that was performed, Amphivena was required to pay to Affimed service fees totaling approximately 16.0 million payable according
to the achievement of milestones and phase progressions as described under the license and development agreement. Since the expiration
of the agreement, the parties have been closing out the collaboration by exchanging documentation and transferring materials and
third party contracts.
Affimed recognized revenue of 8.6 million upon achievement
of three milestones consisting of the earned milestone payments of 9.0 million less Affimed's share in funding Amphivena
of 0.4 million. In the first quarter of 2015, the Group recognized revenue of 2.4 million for the achievement of the
third milestone (such amount had been previously received in cash in 2014 and deferred until the milestone was achieved).
After the achievement of the third milestone, the Group continued
to provide research and development services to Amphivena for nonrefundable advance payments of 7.5 million in the aggregate,
payable in three installments
Notes to the consolidated financial statements
( 1.3 million, 4.2 million and 2.0 million).
Revenue for these research and development services is recognized, net of Affimed's share in funding Amphivena, over the
service performance period. The first two installments of 5.2 million ( 5.5 million, net of Affimed's share of
0.3 million) were received in 2015, and an additional amount of 0.5 million was received in October 2016: 1.5
million as partial payment for the third installment, net of Affimed's share of 1.0 million in an additional financing
of Amphivena by Amphivena's existing investors. Affimed has committed to invest up to an additional 0.5 million in
The Company recognized 0.6 million and 3.4 million
as revenue for research and development services in the three and nine months ended September 30, 2016, net of Affimed's
share in funding Amphivena while services were provided under the license and development agreement (2015: 0.5 million and
Notes to the consolidated financial statements
Collaboration agreement The Leukemia & Lymphoma Society
Affimed is party to a collaboration with LLS to fund the development
of a specific TandAb. 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 to not continue the
commercialization, Affimed must at its option either repay the amount funded or grant a license to LLS to enable LLS to continue