Full Press Release Details
INDEX TO CONDENSED CONSOLIDATED FINANCIAL
| Page | |
| 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 (in thousand)
| For the three months ended March 31 | ||||
| Note | 2015 | 2016 | ||
| Revenue | 3 | 2,538 | 1,936 | |
| Other income - net | 4 | 229 | 86 | |
| Research and development expenses | 8 | (2,921) | (7,068) | |
| General and administrative expenses | 8 | (1,848) | (2,093) | |
| Operating loss | (2,002) | (7,139) | ||
| Finance income / (costs) - net | 5 | 518 | (1,322) | |
| Loss before tax | (1,484) | (8,461) | ||
| Income taxes | 0 | (1) | ||
| Loss for the period | (1,484) | (8,462) | ||
| Total comprehensive loss | (1,484) | (8,462) | ||
| Loss per share in per share | (0.06) | (0.25) | ||
| (undiluted = diluted) |
The Notes are an integral part of these consolidated financial
Condensed consolidated statement
of financial position (in thousand)
| Note | December 31, 2015 | March 31, 2016 | ||
| (unaudited) | ||||
| ASSETS | ||||
| Non-current assets | ||||
| Intangible assets | 72 | 73 | ||
| Leasehold improvements and equipment | 915 | 932 | ||
| 987 | 1,005 | |||
| Current assets | ||||
| Inventories | 228 | 242 | ||
| Trade and other receivables | 915 | 1,923 | ||
| Other assets | 6 | 452 | 682 | |
| Financial assets | 7 | 0 | 17,567 | |
| Cash and cash equivalents | 76,740 | 49,181 | ||
| 78,335 | 69,595 | |||
| TOTAL ASSETS | 79,322 | 70,600 | ||
| EQUITY AND LIABILITIES | ||||
| Equity | ||||
| Issued capital | 333 | 333 | ||
| Capital reserves | 187,169 | 188,116 | ||
| Accumulated deficit | (120,228) | (128,690) | ||
| Total equity | 67,274 | 59,759 | ||
| Non current liabilities | ||||
| Borrowings | 9 | 3,104 | 2,509 | |
| Total non-current liabilities | 3,104 | 2,509 | ||
| Current liabilities | ||||
| Trade and other payables | 4,444 | 4,711 | ||
| Borrowings | 9 | 1,472 | 1,920 | |
| Deferred revenue | 3 | 3,028 | 1,701 | |
| Total current liabilities | 8,944 | 8,332 | ||
| TOTAL EQUITY AND LIABILITIES | 79,322 | 70,600 |
Unaudited condensed consolidated
statement of cash flows
| For the three months ended March 31 | ||||||||||||
| Note | 2015 | 2016 | ||||||||||
| Cash flow from operating activities | ||||||||||||
| Loss for the period | (1,484 | ) | (8,462 | ) | ||||||||
| Adjustments for the period: | ||||||||||||
| - Income taxes | 0 | 1 | ||||||||||
| - Depreciation and amortization | 84 | 105 | ||||||||||
| - Share based payments | 8 | 342 | 947 | |||||||||
| - Finance income / costs - net | 5 | (518 | ) | 1,322 | ||||||||
| (1,576 | ) | (6,087 | ) | |||||||||
| Change in trade and other receivables | (118 | ) | (999 | ) | ||||||||
| Change in inventories | (2 | ) | (14 | ) | ||||||||
| Change in other assets | 0 | (230 | ) | |||||||||
| Change in trade and other payables | (2,090 | ) | (1,060 | ) | ||||||||
| Cash used in operating activities | (3,786 | ) | (8,390 | ) | ||||||||
| Interest received | 2 | 0 | ||||||||||
| Paid interest | (140 | ) | (125 | ) | ||||||||
| Net cash used in operating activities | (3,924 | ) | (8,515 | ) | ||||||||
| Cash flow from investing activities | ||||||||||||
| Purchase of intangible assets | (5 | ) | (10 | ) | ||||||||
| Purchase of leasehold improvements and equipment | (32 | ) | (113 | ) | ||||||||
| Cash paid for investments in current financial assets | 7 | 0 | (18,128 | ) | ||||||||
| Net cash used for investing activities | (37 | ) | (18,251 | ) | ||||||||
| Cash flow from financing activities | 0 | 0 | ||||||||||
| Net changes to cash and cash equivalents | (3,961 | ) | (26,766 | ) | ||||||||
| Cash and cash equivalents at the beginning of the period | 39,725 | 76,740 | ||||||||||
| Exchange-rate related changes of cash and cash equivalents | 1,269 | (793 | ) | |||||||||
| Cash and cash equivalents at the end of the period | 37,033 | 49,181 |
The Notes are an integral part of these consolidated financial
Unaudited condensed consolidated statement
of changes in equity (in thousand)
| Note | Issued capital | Capital reserves | Accumulated deficit | Total equity | ||||||
| Balance as of January 1, 2015 | 240 | 131,544 | (99,989) | 31,795 | ||||||
| Equity-settled share based payment awards | 342 | 342 | ||||||||
| Loss for the period | (1,484) | (1,484) | ||||||||
| Balance as of March 31, 2015 | 240 | 131,886 | (101,473) | 30,653 | ||||||
| Balance as of January 1, 2016 | 333 | 187,169 | (120,228) | 67,274 | ||||||
| Equity-settled share based payment awards | 8 | 947 | 947 | |||||||
| Loss for the period | (8,462) | (8,462) | ||||||||
| Balance as of March 31, 2016 | 333 | 188,116 | (128,690) | 59,759 |
Notes are an integral part of these consolidated financial statements.
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 March 31, 2016 comprise the Company and its wholly owned and controlled subsidiaries
Affimed GmbH, Heidelberg, Germany, 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 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 months ended March 31, 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 the Affimed N.V.'s annual consolidated financial statements as at 31 December 2015.
The interim financial statements were authorized
for issuance by the management board on May 18, 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
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.
| 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 |
1 Shall apply for periods beginning
on or after the effective date.
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
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 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 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 |
1 Shall apply for periods beginning
on or after the effective date.
The Company has not yet determined if any
of these amendments to standards and new or amended interpretations have an effect on its financial statements.
Collaboration agreement Amphivena
is party to a collaboration with Amphivena Therapeutics Inc., San Francisco, USA (in the following Amphivena) to develop a
product candidate for hematologic malignancies. The collaboration consists of a series of linked transactions which in
substance form a research and development collaboration. Amphivena is a structured entity with one project and uses the
funding it receives from investors (which include Affimed) and Janssen Biotech Inc., Horsham, USA (in the following Janssen)
to pay Affimed for its research and development services. Once approval of an investigational new drug application (IND) for
the product candidate is obtained, Janssen has an option to acquire Amphivena on predetermined terms.
The relevant linked agreements consist of:
Pursuant to the license and development
agreement between Affimed and Amphivena, Affimed grants 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 to be performed, Amphivena could be required to pay to Affimed service fees totaling approximately 16
million (net of Affimed's share in funding Amphivena) payable according to the achievement of milestones and phase progressions
as described under the license and development agreement.
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
The Group continues to provide research
and development services to Amphivena for nonrefundable advance payments of 7.5 million in the aggregate, payable in three
installments ( 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 of 0.3 million, over the service performance period. The
first two installments totaling 5.2 million ( 5.5 million, net of Affimed's share of 0.3 million) were received
in 2015. The Company recognized 1.4 million as revenue for these research and development services in the three months ended
March 31, 2016. 1.4 million and 2.8 million were deferred as of March 31, 2016 and December 31, 2015, respectively.
Amphivena has obtained funding solely by
issuing preferred stock to investors and under the warrant agreement with Janssen. Investors have provided financing in exchange
for preferred stock issued by Amphivena under the terms of a stock purchase agreement. Affimed has participated in the financing
of Amphivena in the amount of 0.7 million.