UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
__________________
FORM 6-K
__________________
Report of Foreign Private Issuer
Pursuant to Rule 13a-16 or 15d-16 of
the Securities Exchange Act of 1934
For the month of May, 2015
Commission File Number: 001-36619
__________________________________
Affimed N.V.
__________________________________
Im Neuenheimer Feld 582,
69120 Heidelberg,
Germany
(Address of principal executive offices)
__________________________________
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F ☒ Form 40-F ☐
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ☐
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ☐
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized, in Heidelberg, Germany, May 21, 2015.
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AFFIMED N.V.
| |||
| By: | /s/ Adi Hoess | ||
| Name: | Adi Hoess | ||
| Title: | Chief Executive Officer | ||
| By: | /s/ Florian Fischer | ||
| Name: | Florian Fischer | ||
| Title: | Chief Financial Officer | ||
EXHIBIT INDEX
| Exhibit | Description of Exhibit |
| 1 | Affimed N.V. Unaudited Condensed Consolidated Interim Financial Statements as of March 31, 2015 |
| 2 | Affimed N.V. Management’s Discussion and Analysis of Financial Condition and Results of Operations |
| 3 | Affimed N.V. Press Release dated May 21, 2015 |
Exhibit 1
AFFIMED N.V.
INDEX TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
| Page | |
| Unaudited condensed consolidated statement of comprehensive 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 |
1
| Affimed N.V. | ||||||||
| Unaudited condensed consolidated statement of comprehensive loss | ||||||||
| (in € thousand) | ||||||||
| For the three months ended March 31, | ||||||||
| Note | 2014 | 2015 | ||||||
| Revenue | 3 | 722 | 2,538 | |||||
| Other income - net | 4 | 45 | 229 | |||||
| Research and development expenses | 4 | (5,346 | ) | (2,921 | ) | |||
| General and administrative expenses | (4,735 | ) | (1,848 | ) | ||||
| Operating loss | (9,314 | ) | (2,002 | ) | ||||
| Finance income / (costs) - net | 5 | (6,401 | ) | 518 | ||||
| Loss before tax | (15,715 | ) | (1,484 | ) | ||||
| Income taxes | 69 | 0 | ||||||
| Loss for the period | (15,646 | ) | (1,484 | ) | ||||
| Comprehensive loss | (15,646 | ) | (1,484 | ) | ||||
| Loss per share in € per share | (1.06 | ) | (0.06 | ) | ||||
| (undiluted = diluted) | ||||||||
The notes are an integral part of these condensed consolidated financial statements.
2
Affimed N.V.
Condensed consolidated statement of financial position
(in € thousand)
| Note | December 31, 2014 | March 31, 2015 | ||||||
| (unaudited) | ||||||||
| ASSETS | ||||||||
| Non-current assets | ||||||||
| Intangible assets | 72 | 70 | ||||||
| Leasehold improvements and equipment | 974 | 929 | ||||||
| 1,046 | 999 | |||||||
| Current assets | ||||||||
| Inventories | 199 | 201 | ||||||
| Trade and other receivables | 939 | 1,057 | ||||||
| Cash and cash equivalents | 39,725 | 37,033 | ||||||
| 40,863 | 38,291 | |||||||
| TOTAL ASSETS | 41,909 | 39,290 | ||||||
| EQUITY AND LIABILITIES | ||||||||
| Equity | ||||||||
| Issued capital | 240 | 240 | ||||||
| Capital reserves | 131,544 | 131,886 | ||||||
| Accumulated deficit | (99,989 | ) | (101,473 | ) | ||||
| Total equity | 31,795 | 30,653 | ||||||
| Non current liabilities | ||||||||
| Borrowings | 7 | 3,895 | 4,508 | |||||
| Total non-current liabilities | 3,895 | 4,508 | ||||||
| Current liabilities | ||||||||
| Trade and other payables | 3,759 | 3,113 | ||||||
| Deferred revenue | 3 | 2,460 | 1,016 | |||||
| Total current liabilities | 6,219 | 4,129 | ||||||
| TOTAL EQUITY AND LIABILITIES | 41,909 | 39,290 | ||||||
The notes are an integral part of these condensed consolidated financial statements.
3
| Affimed N.V. | ||||||||
| Unaudited condensed consolidated statement of cash flows | ||||||||
| (in € thousand) | ||||||||
| For the three months ended March 31, | ||||||||
| Note | 2014 | 2015 | ||||||
| Cash flow from operating activities | ||||||||
| Loss for the period | (15,646 | ) | (1,484 | ) | ||||
| Adjustments for the period: | ||||||||
| - Income taxes | (69 | ) | 0 | |||||
| - Depreciation and amortisation | 105 | 84 | ||||||
| - Share based payments | 6 | 7,582 | 342 | |||||
| - Finance income / costs - net | 5 | 6,401 | (518 | ) | ||||
| (1,627 | ) | (1,576 | ) | |||||
| Change in trade and other receivables | 334 | (118 | ) | |||||
| Change in inventories | 2 | (2 | ) | |||||
| Change in trade and other payables | 2,227 | (2,090 | ) | |||||
| Cash generated from operating activities | 936 | (3,786 | ) | |||||
| Interest received | 0 | 2 | ||||||
| Paid interest | (17 | ) | (140 | ) | ||||
| Net cash from (used in) operating activities | 919 | (3,924 | ) | |||||
| Cash flow from investing activities | ||||||||
| Purchase of intangible assets | (19 | ) | (5 | ) | ||||
| Purchase of leasehold improvements and equipment | (7 | ) | (32 | ) | ||||
| Net cash used for investing activities | (26 | ) | (37 | ) | ||||
| Cash flow from financing activities | 0 | 0 | ||||||
| Net changes to cash and cash equivalents | 893 | (3,961 | ) | |||||
| Cash and cash equivalents at the beginning of the period | 4,151 | 39,725 | ||||||
| Exchange-rate related changes of cash and cash equivalents | 0 | 1,269 | ||||||
| Cash and cash equivalents at the end of the period | 5,044 | 37,033 | ||||||
The notes are an integral part of these condensed consolidated financial statements.
4
| Affimed N.V. | ||||||||||||||||||||
| Unaudited condensed consolidated statement of changes in equity | ||||||||||||||||||||
| (in € thousand) | ||||||||||||||||||||
| Note | Issued capital | Capital reserves | Own shares | Accumulated deficit | Total equity | |||||||||||||||
| Balance as of January 1, 2014 | 63 | 469 | (25 | ) | (99,730 | ) | (99,223 | ) | ||||||||||||
| Loss for the period | (15,646 | ) | (15,646 | ) | ||||||||||||||||
| Balance as of March 31, 2014 | 63 | 469 | (25 | ) | (115,376 | ) | (114,869 | ) | ||||||||||||
| Balance as of January 1, 2015 | 240 | 131,544 | 0 | (99,989 | ) | 31,795 | ||||||||||||||
| Equity-settled share based payment awards | 6 | 342 | 342 | |||||||||||||||||
| Loss for the period | (1,484 | ) | (1,484 | ) | ||||||||||||||||
| Balance as of March 31, 2015 | 240 | 131,886 | 0 | (101,473 | ) | 30,653 | ||||||||||||||
The notes are an integral part of these condensed consolidated financial statements.
5
Affimed N.V.
Notes to the consolidated financial statements
(in € thousand)
| 1. | Reporting entity |
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 Company was founded as Affimed Therapeutics B.V. on May 14, 2014 as a private company with limited liability (besloten vennootschap met beperkte aansprakelijkheid) for the purpose of a corporate reorganization of Affimed GmbH (formerly Affimed Therapeutics AG) and converted its legal form under Dutch law to a public company with limited liability for an initial public offering of its common shares.
The condensed consolidated financial statements of Affimed as of and for the period ended March 31, 2015 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. Financial information presented in the consolidated financial statements for periods prior to the consummation of the corporate reorganization on September 17, 2014 is that of Affimed Therapeutics AG and its subsidiary AbCheck s.r.o. Affimed N.V. had not conducted any operations and had not held any assets or liabilities, including contingent liabilities, prior to the reorganization. Affimed Inc. was formed in February 2015 and provides internal services for the Group.
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 immune-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.
| 2. | Basis of preparation and changes to Group’s accounting policies |
Statement of compliance
The interim financial statements for the three months ended March 31, 2015 and 2014 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 2014.
The interim financial statements were authorized for issuance by the management board on May 13, 2015.
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, 2014.
6
Affimed N.V.
Notes to the consolidated financial statements
(in € thousand)
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, 2014 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 time
A number of amendments to standards and new or amended interpretations are effective for annual periods beginning on or before January 1, 2015, and have been applied in preparing these financial statements.
| Standard/interpretation | Effective Date 1 |
| Annual Improvements to IFRSs 2010-2012 Cycle | July 1, 2014 |
| Annual Improvements to IFRSs 2011-2013 Cycle | July 1, 2014 |
1 Shall apply for periods beginning on or after shown in the effective date column.
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, 2015, and have not been applied in preparing these consolidated financial statements.
7
Affimed N.V.
Notes to the consolidated financial statements
(in € thousand)
| 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 |
| IFRS 15 Revenue from Contracts with Customers | January 1, 2017 |
| IFRS 9 Financial Instruments (2014) | January 1, 2018 |
1 Shall apply for periods beginning on or after shown in the effective date column.
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.
| 3. | Revenue |
Collaboration agreement Amphivena
Affimed 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 and the investors could receive further payments.
The relevant linked agreements consist of:
| · | a license and development agreement between Affimed and Amphivena, |
| · | a stock purchase agreement between Amphivena, its investors (which include Affimed) for purposes of financing Amphivena, and |
| · | a warrant agreement between Amphivena and Janssen for purposes of financing Amphivena and providing Janssen the option to acquire the results of the research and development activities through an acquisition of Amphivena following IND approval. |
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 €16.0 million payable according to the achievement of milestones and phase progressions as described under the license and development agreement. Affimed recognized revenue of €4.4 million and €1.8 million in 2013 and 2014 upon achievement of the milestones consisting of the earned milestone payments of €4.6 million and €2.0 million less Affimed’s share in funding Amphivena of €0.2 million and €0.2 million, respectively. In the first quarter of 2015, the Group recognized revenue of €2.4 million for the achievement of the third milestone which had been received in cash in 2014 and deferred until the milestone was achieved.
8
Affimed N.V.
Notes to the consolidated financial statements
(in € thousand)
After the achievement of the third milestone, the Group is eligible for advance payments for research and development services for a total of €7.5 million, payable in three instalments. The first instalment of €1.3 million was received in the first quarter of 2015 less Affimed’s share in funding Amphivena of €0.3 million. The payment was deferred as of March 31, 2015.
Collaboration agreement The Leukemia & Lymphoma Society (LLS)
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 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 (€13.2 million).
The Company achieved the milestones in January and April 2014 and received related payments of $ 1.5 million (€ 1.1 million); €0.6 million was recognized as revenue in the first quarter of 2014.
| 4. | Research and development expenses |
Government grants
The Company receives certain government grants that support its research effort in defined projects. These grants generally provide for reimbursement of approved costs incurred as defined in the respective grants.
Income in respect of grants also includes contributions towards the costs of research and development. Income is recognized when costs under each grant are incurred in accordance with the terms and conditions of the grant and the collectability of the receivable is reasonably assured.
Government grants relating to costs are deferred and recognized in the income statement over the period necessary to match them with the costs they are intended to compensate. When the cash in relation to recognized government grants is not yet received the amount is included as a receivable on the statement of financial position.
The Company recognizes income from government grants under ‘Other income’ in the consolidated statement of comprehensive loss. In the first quarter of 2015 an amount of €254 (first quarter of 2014 €31) was recognized.
9
Affimed N.V.
Notes to the consolidated financial statements
(in € thousand)
| 5. | Finance income and finance costs |
| Three months ended March 31, 2014 | Three months ended March 31, 2015 | ||
| Changes in fair value of derivative conversion feature | (5,046) | 0 | |
| Interest Preferred Shares | (1,162) | 0 | |
| Interest Convertible Loan | (176) | 0 | |
| Interest Perceptive Loan Agreement | 0 | (164) | |
| Foreign exchange differences | (16) | 682 | |
| Other finance income/finance costs | (1) | 0 | |
| Finance income/costs - net | (6,401) | 518 | |
| 6. | Share-based payments |
In the corporate reorganization on September 17, 2014, an equity-settled share based payment program was established by Affimed N.V. (ESOP 2014). Based on this program, the Company has granted 715,000 options as of March 31, 2015 (December 31, 2014: 555,000 options) to certain members of the Management Board and the Supervisory Board, consultants and employees. The awards vest in installments over three years, with strike prices of $6.27 for 535,000 options granted on September 17, 2014, $6.20 for 20,000 options granted on November 19, 2014, $5.18 for 110,000 options granted on January 26, 2015 and $6.15 for 50,000 options granted on March 16, 2015. The final exercise date of the options is 10 years after the grant date of the instruments. As of March 31, 2015 and December 31, 2014, none of the ESOP 2014 awards outstanding had vested.
In the three months ended March 31, 2015, compensation expense of €342 was recognized affecting research and development expenses (€92) and general and administrative expenses (€250). In the three months ended March 31, 2014, compensation expense for share-based compensation awards under the then outstanding ESOP 2007 and carve-out plans of €7,582 was recognized, affecting research and development expenses (€3,582) and general and administrative expenses (€4,000).
| 7. | Borrowings |
Perceptive loan agreement
In July 2014, the Company entered into a credit facility agreement of $14 million and drew an amount of $5.5 million as of July 31, 2014. Repayment will start in April 2016 in monthly installments of $200, with the final balance due in August 2018. Finance costs comprise interest of an annual rate of LIBOR plus a margin of 9%, and an arrangement fee in the amount of 2% of the facility. In addition, the Company issued 106,250 warrants to the lender. The warrants are convertible into common shares of the Company with a strike price of $8.80. Upon initial recognition, the fair value of the warrant of €613 was recognized in equity, net of tax of €183. Fair value was determined using the Black-Scholes-Merton
10
Affimed N.V.
Notes to the consolidated financial statements
(in € thousand)
formula, with an expected volatility of 65% and an expected time of six years to exercise of the warrant. The contractual maturity of the warrant is ten years.
The loan is collateralized by shares in AbCheck s.r.o., certain bank accounts, receivables and certain intellectual property rights with a total carrying amount of €11,094.
The loan is measured at amortized cost using the effective interest method. Interest costs of €164 and foreign exchange losses of €587 have been recognized in profit or loss of the three months ended March 31, 2015. The Company believes that the fair value of the liability does not differ significantly from its carrying amount of €4,508 as of March 31, 2015 due to the limited time passed after issuance.
| 8. | Related parties |
The supervisory directors of Affimed N.V. received compensation for their services on the supervisory board of €66 in the three months ended March 31, 2015, remuneration of managing directors amounted to €358. The Group recognized share-based payment expenses of €51 for supervisory directors and €265 for managing directors in the three months ended March 31, 2015.
In the three months ended March 31, 2014 selected managing directors and supervisory directors received payments related to consulting services. In connection with the IPO, the consulting agreements were terminated.
The following table provides the transaction amounts and outstanding balances for consulting fees and supervisory board remuneration related to key management personnel.
| Transaction volume | Outstanding balances | |||||||
| Three months | Three months | |||||||
| ended March | ended March | December 31, | March 31, | |||||
| 31, 2014 | 31, 2015 | 2014 | 2015 | |||||
| Dr. Adolf Hoess | 57 | 0 | 0 | 0 | ||||
| MedVenture Partners GmbH (Dr. Florian Fischer) | 47 | 0 | 0 | 0 | ||||
| Hecht Healthcare Consulting (Dr. Thomas Hecht) | 16 | 0 | 19 | 0 | ||||
| Bio Pharma Consulting Services LLC (Dr. Richard Stead) | 8 | 0 | 6 | 0 | ||||
| Dr. Thomas Hecht | 0 | 30 | 0 | 20 | ||||
| Dr. Richard Stead | 0 | 9 | 0 | 6 | ||||
| Berndt Modig | 0 | 12 | 7 | 8 | ||||
| Ferdinand Verdonck | 0 | 15 | 7 | 11 | ||||
| Eugene Zhukovsky | 0 | 0 | 16 | 0 | ||||
| 9. | Subsequent events |
On May 12, 2015 we announced the closing of our previously announced public offering of 5,750,000 of our common shares at a public offering price of $7.15 per common share. The total amount includes 750,000 common shares issued pursuant to the underwriters’ option to purchase additional shares which was exercised on May 7, 2015. After deducting the underwriting discounts and other estimated offering expenses, the net proceeds of the public offering are expected to be approximately $37.1 million.
11
Exhibit 2
AFFIMED N.V.
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
This management’s discussion and analysis is designed to provide you with a narrative explanation of our financial condition and results of operations. We recommend that you read this in conjunction with our unaudited interim condensed consolidated financial statements for the three month periods ended March 31, 2015 and 2014 included as Exhibit 1 to the Report on Form 6-K to which this discussion is included. We also recommend that you read our management’s discussion and analysis and our audited consolidated financial statements for fiscal year 2014, and the notes thereto, which appear in our Annual Report on Form 20-F for the year ended December 31, 2014 (the “Annual Report”) filed with the U.S. Securities and Exchange Commission (the “SEC”).
Unless otherwise indicated or the context otherwise requires, all references to “Affimed” or the “company,” “we,” “our,” “ours,” “us” or similar terms refer to Affimed N.V. and its subsidiaries.
We prepare and report our consolidated financial statements and financial information in accordance with International Financial Reporting Standards (“IFRS”) as issued by the International Accounting Standards Board (the “IASB”). None of our financial statements were prepared in accordance with generally accepted accounting principles in the United States. We maintain our books and records in euros. We have made rounding adjustments to some of the figures included in this management’s discussion and analysis. Accordingly, numerical figures shown as totals in some tables may not be an arithmetic aggregation of the figures that precede them. Unless otherwise indicated, all references to currency amounts in this discussions and analysis are in euros.
Overview
We are a clinical-stage biopharmaceutical company focused on discovering and developing highly targeted cancer immunotherapies. Our product candidates are being 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. The most potent cells of the human defense arsenal are types of white blood cells called Natural Killer cells, or NK-cells, and T-cells. Our proprietary, next-generation bispecific antibodies, which we call TandAbs because of their tandem antibody structure, are designed to direct and establish a bridge between either NK-cells or T-cells and cancer cells. Our TandAbs have the ability to bring NK-cells or T-cells into proximity and trigger a signal cascade that leads to the destruction of cancer cells. Due to their novel tetravalent architecture, our TandAbs bind to their targets with high affinity and have half-lives that allow intravenous administration rather than require continuous infusion. We believe, based on their mechanism of action and the preclinical and clinical data we have generated to-date, that our product candidates, alone or in combination, may ultimately improve response rates, clinical outcomes and survival in cancer patients and could eventually become a cornerstone of modern targeted oncology care.
To date, we have financed our operations primarily through our public offerings of our common shares, private placements of equity securities, the incurrence of loans including convertible loans and through government grants and milestone payments for collaborative research and development services. Through May 12, 2015, we have raised an aggregate of €151.2 million through our public offerings as well as private issuances of equity and incurrence of loans. To date, we have not generated any revenues from product sales or royalties. Based on our current plans, we do not expect to generate product or royalty revenues unless and until we or any collaboration partner obtain marketing approval for, and commercialize, any of our product candidates.
We have generated losses since we began our drug development operations in 2000. As of March 31, 2015, we had an accumulated deficit of €101.5 million.
We expect to continue incurring losses as we continue our preclinical and clinical development programs, apply for marketing approval for our product candidates and, subject to obtaining regulatory approval for our product candidates, build a marketing and sales team to commercialize our product candidates. Our profitability is dependent upon the successful development, approval, and commercialization of our product candidates and achieving a level of revenues adequate to support our cost structure. We may never achieve profitability, and unless and until we do, we will continue to need to raise additional cash. We intend to fund future operations through additional equity and debt financings, and we may seek additional capital through arrangements with strategic partners or from other sources.
1
Recent Developments
In early 2015, Affimed was awarded a €2.4 million ($3 million) grant program from the German Federal Ministry of Education and Research (BMBF) to support development of dual tumor targeting antibodies for enhanced selectivity in immune cell engaging therapy. The grant, awarded under the BMBF’s “KMU-innovative: Biotechnology – BioChance” program, will cover approximately 40% of expenses for a research and development program to develop multi-specific antibodies for the treatment of multiple myeloma.
On May 12, 2015 we announced the closing of our previously announced public offering of 5,750,000 of our common shares at a public offering price of $7.15 per common share. The total amount includes 750,000 common shares issued pursuant to the underwriters’ option to purchase additional shares which was exercised on May 7, 2015. After deducting the underwriting discounts and other estimated offering expenses, the net proceeds of the public offering are expected to be approximately $37.1 million.
We have initiated the phase 2a clinical trial of AFM13 with Hodgkin Lymphoma, or HL, and expect interim data in late 2015 and final data in the second half of 2016.
Collaboration and License Agreements
There have been no material changes to our collaboration and license agreements from those reported in “Management’s Discussion and Analysis of Financial Condition and Results of Operations – Collaboration Agreements” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations – License Agreements” in the Annual Report.
Research and Development Expense
Our research and development expense is highly dependent on the development phases of our research projects and therefore fluctuates highly from period to period. Our research and development expense mainly relates to the following key programs:
| § | AFM13. We have initiated the phase 2a clinical trial of AFM13 with Hodgkin Lymphoma, or HL. In addition we plan to support an additional phase 1b/2a investigator initiated trial in CD30+ lymphoma and a Phase 1b trial of AFM13 in combination with a CPI (checkpoint inhibitor) or CPA (checkpoint agonist). We anticipate that our research and development expenses will increase substantially in connection with the commencement of these clinical trials. In addition we are also manufacturing clinical trial material and are investigating commercial scale production options. |
| § | AFM11. We have recently initiated a phase 1 clinical trial of AFM11 in patients with non-Hodgkin Lymphoma, or NHL. We anticipate that our research and development expenses will increase as we continue to enroll patients for this clinical trial and add an additional site in the United States. Furthermore we are going to allocate funds for the investigation of different dose regimens of AFM11 for the treatment of NHL and ALL. In 2013, the costs we incurred were primarily related to the cGMP manufacturing of clinical material for the phase 1 trial. In 2014 and in the first quarter of 2015, however, costs predominantly related to preparatory work for our phase 1 clinical trial. |
| § | Other development programs. Our other research and development expenses relate to our preclinical studies of AFM21, our Amphivena collaboration and discovery activities. The expenses mainly consist of salaries, costs for production of material for preclinical testing and costs paid to contract research organizations in conjunction with preclinical-testing. We also expect to use a portion of our funds for preclinical development of AFM21 and other research and development activities and for working capital, repayment of debt and general corporate purposes. |
Results of Operations
The numbers below have been derived from our unaudited interim condensed consolidated financial statements as of and for the three month period ended March 31, 2014 and 2015. The discussion below should be read along with these financial statements, and it is qualified in its entirety by reference to them.
2
Comparison of the three months ended March 31, 2014 and 2015
Three Months ended March 31, | ||||||||
| 2014 | 2015 | |||||||
(unaudited) (in € thousand) | ||||||||
| Total Revenue: | 722 | 2,538 | ||||||
| Other income/(expenses)—net | 45 | 229 | ||||||
| Research and development expenses | (5,346 | ) | (2,921 | ) | ||||
| General and administrative expenses | (4,735 | ) | (1,848 | ) | ||||
| Operating loss | (9,314 | ) | (2,002 | ) | ||||
| Finance income / (costs)—net | (6,401 | ) | 518 | |||||
| Loss before tax | (15,715 | ) | (1,484 | ) | ||||
| Income taxes | 69 | 0 | ||||||
| Loss for the period | (15,646 | ) | (1,484 | ) | ||||
| Total comprehensive loss | (15,646 | ) | (1,484 | ) | ||||
| Loss per common share in € per share | (1.06 | ) | (0.06 | ) | ||||
Revenue
Revenue increased by 252% from €0.7 million in the three months ended March 31, 2014 to €2.5 million for the three months ended March 31, 2015, mainly due to the revenue recognition upon achievement of a milestone pursuant to the Amphivena collaboration.
Research and development expenses
| Three months ended March 31, | ||||||||||||
| R&D Expenses by Project | 2014 | 2015 | Change % | |||||||||
| (unaudited) | ||||||||||||
| (in € thousand) | ||||||||||||
| Project | ||||||||||||
| AFM13 | 210 | 1,266 | 502 | % | ||||||||
| AFM11 | 543 | 301 | (45 | %) | ||||||||
| Other projects | 1,011 | 1,262 | 25 | % | ||||||||
| Share-based payment expense | 3,582 | 92 | (97 | %) | ||||||||
| Total | 5,346 | 2,921 | (45 | %) | ||||||||
3
Research and development expense decreased by 45% from €5.3 million in the three months ended March 31, 2014 to €2.9 million in the three months ended March 31, 2015. Research and development expense for the first quarter 2014 included compensation expense for share-based compensation awards of €3.6 million under the then-outstanding incentive programs (ESOP 2007 and carve-out plan), while research and development expense in the first quarter 2015 only included compensation expense for share-based compensation awards of €0.1 million relating to the ESOP 2014. The variances in project related expense between the three months ended March 31, 2014 and the corresponding period in 2015 are mainly due to the following projects:
| · | AFM13. In the three months ended March 31, 2015 we incurred significant higher expenses than in the three months ended March 31, 2014 primarily due to the production of clinical material for our phase 2a trial and the preparation of the clinical trial. |
| · | AFM11. In the three months ended March 31, 2015, clinical expenses were lower than in the three months ended March 31, 2014, primarily due to the fewer personnel allocated to the project. |
We incur a significant amount of costs associated with our research and development that are non-project specific, including intellectual property-related expenses, depreciation expenses and facility costs. Because these are less dependent on individual ongoing programs, they are not allocated to specific projects.
General and administrative expenses
General and administrative expenses decreased 45% from €4.7 million in the three months ended March 31, 2014 to €1.8 million in the three months ended March 31, 2015. General and administrative expenses for the first quarter 2014 included compensation expense for share-based compensation awards of €4.0 million under the then outstanding incentive programs (ESOP 2007 and carve-out plan), while general and administrative expenses in the first quarter 2015 only include compensation expense for share-based compensation awards of €0.2 million relating to the ESOP 2014.
We expect that our non-transaction related general and administrative expenses will increase in the future as our business expands and we incur additional costs associated with operating as a public company. Transaction related expenses will be incurred whenever we prepare for further financing activities or strategic transactions.
Finance income / (costs)-net
Finance income for the three months ended March 31, 2015 totals €0.5 million, compared with finance costs of €6.4 million for the three months ended March 31, 2014. In the first quarter of 2015, the Company realized net foreign exchange rate gains of €0.7 and interest expenses of €0.2 million. The first quarter of 2014 was primarily affected by the interest expenses for then outstanding preferred shares of €1.2 million and the re-measurement loss resulting from changes in fair value of the derivative conversion feature of €5.0 million.
Income taxes
During the three months ended March 31, 2014, we have recorded an income tax benefit of € 69 which was related to deferred taxes at our subsidiary AbCheck.
Liquidity and Capital Resources
Since inception, we have incurred significant operating losses. To date, we have not generated any product sale revenue. We have financed our operations primarily through our public offerings of our common shares, private placements of equity securities and loans from existing shareholders.
4
Cash flows
Comparison of the three months ended March 31, 2014 and 2015
The table below summarizes our consolidated statement of cash flows for the three months ended March 31, 2014 and 2015:
Three months ended March 31, | ||||||||
| 2014 | 2015 | |||||||
| (unaudited) | ||||||||
| (in € thousand) | ||||||||
| Net cash from (used in) operating activities | 919 | (3,924 | ) | |||||
| Net cash used for investing activities | (26 | ) | (37 | ) | ||||
| Net cash from financing activities | 0 | 0 | ||||||
| Net changes to cash and cash equivalents | 893 | (3,961 | ) | |||||
| Cash and cash equivalents at the beginning of the period | 4,151 | 39,725 | ||||||
| Exchange rate related changes of cash and cash equivalents | 0 | 1,269 | ||||||
| Cash and cash equivalents at the end of the period | 5,044 | 37,033 | ||||||
Net cash used in operating activities of €3.9 million in the three months ended March 31, 2015 is mainly due to the loss of €1.5 million and payments for trade and other payables of €2.1 million. In the first quarter 2014, the Company showed net cash flow from operating activities of €0.9 million mainly due to advance payments of €2.6 million under collaborative agreements.
Cash and Funding Sources
Our cash and cash equivalents as of March 31, 2015 were €37.0 million.
On July 24, 2014, our subsidiary Affimed Therapeutics AG - now Affimed GmbH - entered into an agreement for a loan facility (the “Perceptive Credit Facility”) with an affiliate of Perceptive Advisors LLC (“Perceptive”). The Perceptive Credit Facility provides for aggregate funding of $14.0 million, including $5.5 million in initial funding drawn as of March 31, 2015 and up to an additional $8.5 million of capital available in subsequent tranches. Any portion of the Perceptive Credit Facility that has not been drawn by December 31, 2015 will terminate. The loans outstanding under the Perceptive Credit Facility will accrue interest at an annual rate equal to an applicable margin of nine percent plus one-month LIBOR, with LIBOR deemed to equal 1% if LIBOR is less than 1% and is payable in monthly installments of interest only through April 2016 and then principal and interest thereafter in monthly installments through August 2018, with the outstanding balance to be repaid in full at the end of August 2018. Borrowings under the Perceptive Credit Facility are secured by a substantial portion of our tangible assets and intellectual property. Under the loan agreement governing the Perceptive Credit Facility, we are subject to customary affirmative and negative covenants including limitations on additional indebtedness, limitations on liens and limitations on acquisitions. Additionally, covenants set forth under the Perceptive Credit Facility will require us to maintain a minimum cash balance of $2.0 million. We have also agreed to achieve certain development milestones for AFM11 and AFM13.
We are also obligated to grant Perceptive warrants to purchase our common shares. Following the closing of our initial public offering, we issued to Perceptive 106,250 warrants at an exercise price of $8.80. If and when we make any additional draw under the Perceptive Credit Facility, we will issue to Perceptive an additional 164,205 warrants at the same exercise price.
On September 17, 2014, we completed our initial public offering of common shares in which we sold an aggregate of 8,000,000 common shares at a price to the public of $7.00 per share. The proceeds to us from the offering were approximately €43.2 million, before deducting the underwriting discounts, commissions and offering expenses.
In January 2015, we announced that we had been awarded a €2.4 million ($3 million) grant from the German Federal Ministry of Education and Research (BMBF). The grant, awarded under the BMBF’s “KMU-innovative: Biotechnology–BioChance” program, will cover approximately 40% of expenses for a research and development program to develop multi-specific antibodies for the treatment of multiple myeloma.
5
On May 12, 2015 we announced the closing of our previously announced public offering of 5,750,000 of our common shares at a public offering price of $7.15 per common share. The total amount includes 750,000 common shares issued pursuant to the underwriters’ option to purchase additional shares which was exercised on May 7, 2015. After deducting the underwriting discounts and other estimated offering expenses, the net proceeds of the public offering are expected to be approximately $37.1 million.
Funding Requirements
We expect that we will require additional funding to complete the development of our product candidates and to continue to advance the development of our other product candidates. In addition, we expect that we will require additional capital to commercialize our product candidates AFM13, AFM11 and AFM21. If we receive regulatory approval for AFM13, AFM11 or AFM21, and if we choose not to grant any licenses to partners, we expect to incur significant commercialization expenses related to product manufacturing, sales, marketing and distribution, depending on where we choose to commercialize. We also expect to incur additional costs associated with operating as a public company. Additional funds may not be available on a timely basis, on favorable terms, or at all, and such funds, if raised, may not be sufficient to enable us to continue to implement our long-term business strategy. If we are not able to raise capital when needed, we could be forced to delay, reduce or eliminate our product development programs or commercialization efforts.
We believe that our existing cash and cash equivalents together with the net proceeds from the offering which priced on May 6, 2015 will enable us to fund our operating expenses and capital expenditure requirements at least until the third quarter of 2017. We have based this estimate on assumptions that may prove to be incorrect, and we could use our capital resources sooner than we currently expect. Our future funding requirements will depend on many factors, including but not limited to:
| · | the scope, rate of progress, results and cost of our clinical trials, nonclinical testing, and other related activities; |
| · | the cost of manufacturing clinical supplies, and establishing commercial supplies, of our product candidates and any products that we may develop; |
| · | the number and characteristics of product candidates that we pursue; |
| · | the cost, timing, and outcomes of regulatory approvals; |
| · | the cost and timing of establishing sales, marketing, and distribution capabilities; and |
| · | the terms and timing of any collaborative, licensing, and other arrangements that we may establish, including any required milestone and royalty payments thereunder. |
We may raise additional capital through the sale of equity or convertible debt securities. In such an event, your ownership interest will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect your rights as a holder of our common shares.
For more information as to the risks associated with our future funding needs, see “Risk Factors” in the Annual Report.
Contractual Obligations and Commitments
As of the date of this discussion and analysis there are no material changes to our contractual obligations from those reported in “Management’s Discussion and Analysis of Financial Condition and Results of Operations–Contractual Obligations and Commitments” in the Annual Report.
Off-balance sheet arrangements
As of the date of this discussion and analysis, we do not have any, and during the periods presented we did not have any, off-balance sheet arrangements.
6
Quantitative and Qualitative Disclosures About Market Risk
During the three months ended March 31, 2015, there were no significant changes to our quantitative and qualitative disclosures about market risk from those reported in “Management’s Discussion and Analysis of Financial Condition and Results of Operations–Quantitative and Qualitative Disclosures About Market Risk” in the Annual Report.
Critical Judgments and Accounting Estimates
There have been no material changes to the significant accounting policies and estimates described in “Management’s Discussion and Analysis of Financial Condition and Results of Operations – Critical Judgments and Accounting Estimates” in the Annual Report.
Recent Accounting Pronouncements
The Company has not yet determined the impact of IFRS 9 (Financial Instruments) and IFRS 15 (Revenue from Contracts with Customers) which have been issued by the IASB but not yet adopted on our financial statements.
JOBS Act Exemption
On April 5, 2012, the JOBS Act was signed into law. The JOBS Act contains provisions that, among other things, reduce certain reporting requirements for an “emerging growth company.” As an emerging growth company, we are not required to provide an auditor attestation report on our system of internal controls over financial reporting. This exemption will apply for a period of five years following the completion of our initial public offering or until we no longer meet the requirements of being an “emerging growth company,” whichever is earlier. We would cease to be an emerging growth company if we have more than $1.0 billion in annual revenue, have more than $700 million in market value of our common shares held by non-affiliates or issue more than $1.0 billion of non-convertible debt over a three-year period.
Cautionary Statement Regarding Forward Looking Statements
Forward-looking statements appear in a number of places in this discussion and analysis and include, but are not limited to, statements regarding our intent, belief or current expectations. Many of the forward-looking statements contained in this discussion and analysis can be identified by the use of forward-looking words such as “anticipate,” “believe,” “could,” “expect,” “should,” “plan,” “intend,” “estimate” and “potential,” among others. Forward-looking statements are based on our management’s beliefs and assumptions and on information currently available to our management. Such statements are subject to risks and uncertainties, and actual results may differ materially from those expressed or implied in the forward-looking statements due to of various factors, including, but not limited to, those identified under the section entitled “Risk Factors” in the Annual Report. These risks and uncertainties include factors relating to:
| · | our operation as a development stage company with limited operating history and a history of operating losses; as of March 31, 2015, our accumulated deficit was €101.5 million; |
| · | the chance our clinical trials may not be successful and clinical results may not reflect results seen in previously conducted preclinical studies and clinical trials;
|
| · | our reliance on contract manufacturers and contract research organizations over which we have limited control; |
| · | our lack of adequate funding to complete development of our product candidates and the risk we may be unable to access additional capital on reasonable terms or at all to complete development and begin commercialization of our product candidates; |
| · | our dependence on the success of AFM13 and AFM11, which are still in clinical development and may eventually prove to be unsuccessful; |
7
| · | uncertainty surrounding whether any of our product candidates will receive regulatory approval, which is necessary before they can be commercialized; |
| · | the outcome of any, or any discussions we may enter regarding, acquisitions, dispositions, partnerships, license transactions or changes to our capital structure, including future securities offerings; |
| · | the chance that we may become exposed to costly and damaging liability claims resulting from the testing of our product candidates in the clinic or in the commercial stage; |
| · | if our product candidates obtain regulatory approval, our being subject to expensive ongoing obligations and continued regulatory overview; |
| · | enacted and future legislation may increase the difficulty and cost for us to obtain marketing approval and commercialization; |
| · | the chance that our products may not gain market acceptance, in which case we may not be able to generate product revenues; |
| · | our reliance on our current strategic relationships with the DKFZ, Xoma, LLS, Amphivena and Amphivena’s other investors and partners, including MPM Capital, Aeris Capital and Janssen, and the potential failure to enter into new strategic relationships; |
| · | our reliance on third parties to conduct our nonclinical and clinical trials and on third-party single-source suppliers to supply or produce our product candidates; |
| · | our future growth and ability to compete, which depends on our retaining key personnel and recruiting additional qualified personnel; and |
| · | other risk factors discussed under “Risk Factors” in the Annual Report. |
Forward-looking statements speak only as of the date they are made, and we do not undertake any obligation to update them in light of new information or future developments or to release publicly any revisions to these statements in order to reflect later events or circumstances or to reflect the occurrence of unanticipated events.
8
Exhibit 3
FOR IMMEDIATE RELEASE
Affimed Reports Financial Results for First Quarter 2015
-- Successful Follow-on Offering Supports Continued Progress in Clinical Programs --
Heidelberg, Germany, May 21, 2015 - Affimed N.V. (Nasdaq: AFMD), a clinical-stage biopharmaceutical company developing highly targeted cancer immunotherapies, today reported financial results for the quarter ended March 31, 2015.
“The recent completion of our follow-on offering will allow us to broaden the scope of both our clinical and preclinical programs and we appreciate the support of our investors,” said Dr. Adi Hoess, CEO of Affimed. “We are particularly excited about upcoming results that we will present at the ASCO 2015 Annual Meeting in late May, which continue to demonstrate the strength of our technology and its potential to treat cancer.”
Corporate Highlights
| · | Affimed successfully completed a follow-on offering on the Nasdaq Global Market, raising a total of approximately €32.7 million (US $37.1 million) in net proceeds. This includes the underwriter’s exercise in full of their option to purchase additional shares. The funding is intended for the continued development of Affimed’s pipeline of unencumbered clinical and preclinical assets, allowing the Company to broaden the AFM13 and AFM11 clinical programs and to generate further NK-cell engagers. |
| · | For its lead candidate, AFM13, a bispecific CD30/CD16A TandAb antibody, Affimed has initiated a phase 2a clinical trial in Hodgkin lymphoma, or HL, with first data expected in late 2015 and final data expected in the second half of 2016. The Company is preparing an additional phase 1b/2a investigator-initiated trial with AFM13 in CD30-positive lymphoma as well as a phase 1b trial with AFM13 in combination with a checkpoint modulator. Initial evidence of the synergistic effect of AFM13 in combination with checkpoint modulators will be presented at the upcoming ASCO 2015 Annual Meeting. |
| · | For its second candidate, AFM11, a bispecific CD19/CD3 TandAb antibody, the Company has initiated a phase 1 clinical trial in patients with non-Hodgkin lymphoma (NHL) and acute lymphocytic leukemia (ALL). Furthermore, Affimed intends to investigate different dose regimens of AFM11 for the treatment of NHL and ALL in new studies to be initiated in early 2016. |
| · | Affimed has presented posters on its third program, the EGFRvIII/CD3-targeting T-cell TandAb AFM21, at the American Association for Cancer Research (AACR) and Association for Cancer Immunotherapy (CIMT) 2015 annual meetings, showing high specificity and potency. In addition to AFM21, the Company has generated an NK-cell engager targeting EGFRvIII/CD16A. Both molecules are currently being evaluated in a preclinical setting for their ability to destroy EGFRvIII-positive tumor cells. |
| · | Affimed has published three papers on its lead candidates (AFM13 phase 1 data, Rothe, A. et al., Blood. 2015, Apr. 17, pii: blood-2014-12-614636; AFM11 preclinical data, Reusch, U. et al., MAbs. 2015 May 4;7(3):584-604) and its proprietary technology platform (Weichel, M. et al., European Pharmaceutical Review, 2015, Vol. 20/1, p.27-32). |
| · | Following the March milestone announcement of CD33/CD3 candidate selection for IND-enabling studies in the Company’s collaboration with Amphivena/Janssen, Affimed and its partner Amphivena will provide an update by presenting three posters at the upcoming ASCO 2015 Annual Meeting. |
Financial Highlights
(Figures for the first quarter 2015 and 2014 represent unaudited figures)
Cash and cash equivalents totaled €37.0 million on March 31, 2015 compared to €39.7 million on December 31, 2014. The decrease was primarily attributable to Affimed’s operational expenses.
Net cash used in operating activities was €3.9 million for three months ended March 31, 2015 compared to a net cash flow of €0.9 million for the three months ended March 31, 2014. The increase was mainly due to the loss in the 2015 period of €1.5 million and payments for trade and other payables of €2.1 million. In the first quarter 2014, the Company showed net cash flow from operating activities of €0.9 million mainly due to advance payments of €2.6 million under collaboration agreements.
Revenue for the first quarter of 2015 was €2.5 million compared to €0.7 million for the first quarter of 2014. The revenue in the first quarter 2015 was mainly attributable to the revenue recognition upon achievement of a milestone pursuant to the Amphivena collaboration, whereas the revenue in the first quarter 2014 was mainly attributable to the collaboration with the Leukemia & Lymphoma Society (LLS).
Research and development expenses for the first quarter 2015 were €2.9 million compared to €5.3 million for the first quarter 2014. Research and development expenses for the first quarter 2014 were largely due to non project-related share based payment expenses. The variances in project-related expenses are primarily the result of activities related to the AFM13 and AFM11 projects.
General and administrative (G&A) expenses for the first quarter 2015 were €1.8 million compared to €4.7 million for the first quarter 2014. G&A expenses for the first quarter 2014 were largely due to share based payment expenses.
Net loss for the first quarter 2015 was €1.5 million or €0.06 per common share, compared to a net loss of €15.6 million, or €1.06 per common share, for the first quarter 2014. The decrease is primarily related to significant amounts for share based payment expense and finance costs incurred in the first quarter 2014.
Note on IFRS Reporting Standards
Affimed prepares and reports the consolidated financial statements and financial information in accordance with International Financial Reporting Standards (IFRS) as issued by the International Accounting Standards Board (IASB). None of the financial statements were prepared in accordance with Generally Accepted Accounting Principles (GAAP) in the United States. Affimed maintains its books and records in Euro.
Conference call and webcast information
Affimed’s management will host a conference call to discuss the company’s financial results and recent corporate developments today at 8:30 a.m. EST. A webcast of the conference call can be accessed in the “Events” section on the “Media” page of the Affimed website at http://www.affimed.com/events.php. A replay of the webcast will be available on Affimed’s website shortly after the conclusion of the call and will be archived on the Affimed website for 30 days following the call.
About Affimed N.V.
Affimed is a clinical-stage biopharmaceutical company focused on discovering and developing highly targeted cancer immunotherapies. Affimed’s product candidates are being 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. The most potent cells of the human defense arsenal are types of white blood cells called natural killer cells, or NK-cells, and T-cells. Affimed’s proprietary, next-generation bispecific antibodies, called TandAbs for their tandem antibody structure, are designed to direct and establish a bridge between either NK-cells or T-cells and cancer cells, triggering a signal cascade that leads to the destruction of cancer cells.
FORWARD-LOOKING STATEMENTS
This press release contains forward-looking statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as "anticipate," "believe," "could," "estimate," "expect," "goal," "intend," "look forward to", "may," "plan," "potential," "predict," "project," "should," "will," "would" and similar expressions. Forward-looking statements are based on management's beliefs and assumptions and on information available to management only as of the date of this press release. These forward-looking statements include, but are not limited to, statements regarding the risk of cessation or delay of any of the ongoing or planned clinical studies and/or development of our product candidates. Our actual results could differ materially from those anticipated in these forward-looking statements for many
reasons, including, without limitation, risks associated with our clinical development activities, regulatory oversight, product commercialization, intellectual property claims, and the risks, uncertainties and other factors described under the heading "Risk Factors" in Affimed’s filings with the Securities and Exchange Commission. Given these risks, uncertainties and other factors, you should not place undue reliance on these forward-looking statements, and we assume no obligation to update these forward-looking statements, even if new information becomes available in the future.
Contact:
Affimed N.V.
Caroline Stewart, Head IR & Communication
Phone: +1 347 394 6793
E-Mail: IR@affimed.com or c.stewart@affimed.com
Media requests:
Anca Alexandru or Gretchen Schweitzer
MacDougall Biomedical Communications
Phone: +49 89 2424 3494 or
+49 163 613 3359
E-Mail: aalexandru@macbiocom.com
AFFIMED N.V.
UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Affimed N.V.
Unaudited condensed consolidated statement of comprehensive loss
(in € thousand)
| For the three months ended March 31 | |||
| 2014 | 2015 | ||
| Revenue | 722 | 2,538 | |
| Other income - net | 45 | 229 | |
| Research and development expenses | (5,346) | (2,921) | |
| General and administrative expenses | (4,735) | (1,848) | |
| Operating loss | (9,314) | (2,002) | |
| Finance income / (costs) - net | (6,401) | 518 | |
| Loss before tax | (15,715) | (1,484) | |
| Income taxes | 69 | 0 | |
| Loss for the period | (15,646) | (1,484) | |
| Comprehensive loss | (15,646) | (1,484) | |
| Loss per share in € per share | (1.06) | (0.06) | |
(undiluted = diluted) |
|||
AFFIMED N.V.
UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Affimed N.V.
Condensed consolidated statement of financial position
(in € thousand)
| December 31, 2014 | March 31, 2015 | ||
| (unaudited) | |||
| ASSETS | |||
| Non-current assets | |||
| Intangible assets | 72 | 70 | |
| Leasehold improvements and equipment | 974 | 929 | |
| 1,046 | 999 | ||
| Current assets | |||
| Inventories | 199 | 201 | |
| Trade and other receivables | 939 | 1,057 | |
| Cash and cash equivalents | 39,725 | 37,033 | |
| 40,863 | 38,291 | ||
| TOTAL ASSETS | 41,909 | 39,290 | |
| EQUITY AND LIABILITIES | |||
| Equity | |||
| Issued capital | 240 | 240 | |
| Capital reserves | 131,544 | 131,886 | |
| Accumulated deficit | (99,989) | (101,473) | |
| Total equity | 31,795 | 30,653 | |
|
Non current liabilities |
|||
| Borrowings | 3,895 | 4,508 | |
| Total non-current liabilities | 3,895 | 4,508 | |
| Current liabilities | |||
| Trade and other payables | 3,759 | 3,113 | |
| Deferred revenue | 2,460 | 1,016 | |
| Total current liabilities | 6,219 | 4,129 | |
|
TOTAL EQUITY AND LIABILITIES |
41,909 | 39,290 |
AFFIMED N.V.
UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Affimed N.V.
Unaudited condensed consolidated statement of cash flows
(in € thousand)
| For the three month ended March 31 | |||
| 2014 | 2015 | ||
| Cash flow from operating activities | |||
| Loss for the period | (15,646) | (1,484) | |
| Adjustments for the period: | |||
| - Income taxes | (69) | 0 | |
| - Depreciation and amortisation | 105 | 84 | |
| - Share based payments | 7,582 | 342 | |
| - Finance income / costs - net | 6,401 | (518) | |
| (1,627) | (1,576) | ||
| Change in trade and other receivables | 334 | (118) | |
| Change in inventories | 2 | (2) | |
| Change in trade and other payables | 2,227 | (2,090) | |
| Cash generated from operating activities | 936 | (3,786) | |
| Interest received | 0 | 2 | |
| Paid interest | (17) | (140) | |
| Net cash from (used in) operating activities | 919 | (3,924) | |
| Cash flow from investing activities | |||
| Purchase of intangible assets | (19) | (5) | |
| Purchase of leasehold improvements and equipment | (7) | (32) | |
| Net cash used for investing activities | (26) | (37) | |
| Cash flow from financing activities | 0 | 0 | |
| Net changes to cash and cash equivalents | 893 | (3,961) | |
| Cash and cash equivalents at the beginning of the period | 4,151 | 39,725 | |
| Exchange-rate related changes of cash and cash equivalents | 0 | 1,269 | |
| Cash and cash equivalents at the end of the period | 5,044 | 37,033 | |
AFFIMED N.V.
UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Affimed N.V.
Unaudited condensed consolidated statement of changes in equity
(in € thousand)
| Issued capital | Capital reserves | Own shares | Accumulated deficit | Total equity | ||||||
| Balance as of January 1, 2014 | 63 | 469 | (25) | (99,730) | (99,223) | |||||
| Loss for the period | (15,646) | (15,646) | ||||||||
| Balance as of March 31, 2014 | 63 | 469 | (25) | (115,376) | (114,869) | |||||
| Balance as of January 1, 2015 | 240 | 131,544 | 0 | (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 | 0 | (101,473) | 30,653 |