EX-99.3 4 dp51008_ex03.htm EXHIBIT 3
Exhibit 3
 
 

 
 
Affimed Reports Financial Results for Third Quarter 2014
-- Use of IPO Proceeds to Enhance Clinical Programs --

Heidelberg, Germany, November 18, 2014 - Affimed N.V. (Nasdaq: AFMD), a clinical-stage biopharmaceutical company developing highly targeted cancer immunotherapies, today reported financial results for the quarter ended September 30, 2014.

“Through the completion of our IPO and additional capital raised this past quarter, Affimed is well-positioned to achieve major value creation milestones for our clinical programs AFM13 and AFM11, as well as to complete preclinical development for AFM21, ” said Dr. Adi Hoess, CEO of Affimed. “Affimed remains on target to provide an update on clinical data for both AFM13 and AFM11 during 2015. However, due to a slightly prolonged administrative process, the commencement of the AFM13 phase 2a study is expected to begin in early 2015‎.

Dr. Hoess added: “In the third quarter, we welcomed the addition of Berndt Modig to our Supervisory Board and look forward to the contribution of his financial experience.”

Corporate Highlights
 
·
Affimed raised a total of €44.3 million (US $56.0 million) before subtracting underwriting discounts and commissions in its initial public offering on the Nasdaq Global Market, which closed on September 17, 2014.
 
·
Before the IPO, the company announced the closing of a Series E financing from current investors and a loan agreement: The Series E funding totaled €8.2 million ($11 million). The Company has signed a €10.5 million ($14 million) loan agreement with Perceptive Advisors, of which €4.1 million ($5.5 million) has been drawn.
 
·
The proceeds from the IPO are planned to be used for the continued clinical development of its unencumbered assets AFM13 (indicated for relapsed/refractory patients with Hodgkin Lymphoma and relapsed/refractory patients with Cutaneous T cell Lymphoma), AFM11 (indicated for relapsed/refractory Non-Hodgkin Lymphoma patients) and AFM21 (targeted for the initiation of IND-enabling studies for the treatment of solid tumors in 2015). In addition, Affimed will enhance its T- and NK-cell platforms, including its proprietary trispecific antibodies for dual targeting of tumors.
 
·
Affimed expects the dosing of the first patient in the phase 2a clinical study for AFM13 in early 2015, rather than during the fourth quarter of 2014. These updated timelines are the result of an administrative process at the clinical trial sites and are not
 
 
 
 
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expected to impact the overall timeline for reporting interim clinical results, which are still anticipated during 2015.
 
·
Berndt Modig, Chief Financial Officer of Prosensa Holding N.V. (Nasdaq: RNA), has joined the Affimed Supervisory Board and will serve on the company’s Audit Committee. Prior to joining Prosensa in 2010, Mr. Modig was CFO at Jerini AG and Surplex AG and held leadership positions at Hayward Industrial Products, the private equity firm Agra Industria and Price Waterhouse.

Financial Highlights
Research and development expenses were €3.0 million for the three months ended September 30, 2014, compared to €2.8 million for the same period in 2013. Net income for the third quarter 2014 was €7.2 million or €2.14 per share, compared to a loss of €11.55 million or €40.36 per share for the third quarter 2013. Net cash used in operating activities was €5.2 million for the nine months ended September 30, 2014 compared to €3.4 million for the nine months ended September 30, 2013. As of September 30, 2014, the company held cash and cash equivalents of €45.5 million. The financial results for the third quarter include certain non-operational and non-monetary effects due to our corporate reorganization in connection with the IPO. Additional information regarding these results is included in the notes to the financial statements as of and for the three and nine month period ending September 30, 2014 and the “Management's Discussion and Analysis of Financial Condition and Results of Operations” which are included in Affimed’s Form 6-K as filed with the SEC.

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
 
 
 
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activities, regulatory oversight, product commercialization, intellectual property claims, and the risks, uncertainties and other factors described under the heading "Risk Factors" in Affimed’s prospectus dated September 12, 2014 filed 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.
Adi Hoess, CEO
Phone: +49 6221 65307-0
E-Mail: IR@affimed.com 

 
 
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AFFIMED N.V.
UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
 
 
UNAUDITED CONDENSED CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOME/(LOSS)
 
   
For the three months ended September 30
   
For the nine months ended September 30
 
   
2013
   
2014
   
2013
   
2014
 
      (in thousand)  
Revenue
    191       1,892       462       3,301  
Other income/(expenses) - net
    109       110       459       223  
Research and development expenses
    (2,790 )     (2,181 )     (8,913 )     (5,468 )
General and administrative expenses
    (3,939 )     (249 )     (6,364 )     (600 )
Operating (loss)
    (6,429 )     (428 )     (14,356 )     (2,544 )
Finance income / (costs) - net
    (5,128 )     7,751       (9,202 )     7,547  
Income / (Loss) before tax
    (11,557 )     7,323       (23,558 )     5,003  
Income taxes
    7       10       9       38  
Income / (Loss) for the period
    (11,550 )     7,333       (23,549 )     5,041  
Total comprehensive income / (loss)
    (11,550 )     7,333       (23,549 )     5,041  
Earnings / (Loss) per share in € per share (undiluted = diluted)
    (40.36 )     2.17       (82.29 )     3.79  
 
 
 
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AFFIMED N.V.
UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
 
 
CONDENSED CONSOLIDATED STATEMENT OF FINANCIAL POSITION

   
December 31,
2013
 
   
September 30,
2014
(unaudited)
 
     (in € thousand)  
ASSETS
           
Non-current assets
           
             
Intangible assets
    158       96  
Leasehold improvements and equipment
    1,034       1,044  
Deferred tax assets
    16       55  
      1,208       1,195  
Current assets
               
                 
Inventories
    140       187  
Trade and other receivables
    1,001       932  
Cash and cash equivalents
    4,151       45,546  
      5,292       46,665  
                 
TOTAL ASSETS
    6,500       47,860  
                 
EQUITY AND LIABILITIES
               
Equity
               
                 
Issued capital
    63       240  
Capital reserves
    469       132,231  
Accumulated deficit
    (99,730 )     (94,689 )
Own shares
    (25 )     0  
Total equity
    (99,223 )     37,782  
                 
Non current liabilities
               
                 
Preferred shares
    77,945       0  
Cash settled share based payments
    12,838       0  
Interest-bearing loans long-term
    0       3,670  
Total non-current liabilities
    90,783       3,670  
                 
Current liabilities
               
                 
Derivative conversion feature
    6,196       0  
Trade and other payables
    3,862       4,996  
Borrowings
    4,800       131  
Deferred revenue
    82       1,281  
Total current liabilities
    14,940       6,408  
                 
TOTAL EQUITY AND LIABILITIES
    6,500       47,860  
 
 
 
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AFFIMED N.V.
UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
 
 
UNAUDITED CONDENSED CONSOLIDATED STATEMENT OF CASH FLOWS
 
 
   
For the nine months
ended September 30
 
   
2013
   
2014
 
     (in € thousand)  
Cash flow from operating activities
           
Income / (Loss) for the period
    (23,549 )     5,041  
Adjustments for the period:
               
- Income taxes
    (9 )     (38 )
- Depreciation and amortisation
    308       318  
- Non-cash items
    6,913       (5,152 )
- Finance income / costs - net
    9,202       (7,547 )
      (7,135 )     (7,375 )
Change in trade and other receivables
    143       69  
Change in inventories
    1       (47 )
Change in trade and other payables
    3,585       2,333  
Cash generated from operating activities
    (3,406 )     (5,020 )
Interest received
    2       0  
Paid interest
    (6 )     (83 )
Net cash used in operating activities
    (3,410 )     (5,103 )
Cash flow from investing activities
               
Purchase of intangible assets
    (18 )     (35 )
Purchase of leasehold improvements and equipment
    (128 )     (242 )
Net cash used for investing activities
    (146 )     (270 )
Cash flow from financing activities
               
Proceeds from issue of common shares
    0       43,213  
Transactions costs related to issue of common shares
    0       (4,578 )
Proceeds from issue of preferred shares
    0       2,999  
Proceeds from convertible debt
    5,100       0  
Transactions costs related to preferred shares and convertible debt
    (5 )     0  
Proceeds from Interest-bearing long-term loans
    0       4,020  
Proceeds from other borrowings
    0       130  
Cash flow from financing activities
    5,095       45,784  
                 
Net changes to cash and cash equivalents
    1,539       40,411  
Cash and cash equivalents at the beginning of the period
    4,902       4,151  
Exchange-rate related changes of cash and cash equivalents
    0       984  
Cash and cash equivalents at the end of the period
    6,441       45,546  
 
 
 
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AFFIMED N.V.
UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
 
 
UNAUDITED CONDENSED CONSOLIDATED STATEMENT OF CHANGES IN EQUITY
 

 
   
Issued capital
   
Capital reserves
   
Own shares
   
Accumulated deficit
   
Total equity
 
     (in € thousand)  
Balance as of January 1, 2013
    63       469       (25 )     (73,631 )     (73,124 )
Income / (Loss) for the period
                            (23,549 )     (23,549 )
Balance as of September 30, 2013
    63       469       (25 )     (97,180 )     (96,673 )
Balance as of January 1, 2014
    63       469       (25 )     (99,730 )     (99,223 )
Exchange of preferred shares
    97       81,909       25               82,031  
Issue of common shares
    80       41,554               41,634          
Modification of cash-settled share based payment awards
            7,648                          
Equity-settled share based payment awards
            38                       38  
Issue of warrant note (Perceptive loan)
            613                       613  
Income for the period
                            5,041       5,041  
Balance as of September 30, 2014
    240       132,231       0       (94,689 )     37,782  
 
 
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