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SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
July 29, 2009
 
Date of report (Date of earliest event reported)
SurModics, Inc.
 
(Exact Name of Registrant as Specified in its Charter)
         
Minnesota   0-23837   41-1356149
         
(State of Incorporation)   (Commission File Number)   (I.R.S. Employer
Identification No.)
     
9924 West 74th Street
Eden Prairie, Minnesota
  55344
     
(Address of Principal Executive Offices)   (Zip Code)
(952) 829-2700
 
(Registrant’s Telephone Number, Including Area Code)
     Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2):
o      Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o      Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o      Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o      Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
 
 

 


 

Item 2.02. Results of Operations And Financial Condition.
     On July 29, 2009, SurModics, Inc. issued a press release announcing the results for the quarter ended June 30, 2009. A copy of the full text of the press release is furnished as Exhibit 99.1 to this report.

 


 

Item 9.01 Financial Statements and Exhibits.
     (d) Exhibits.
     
Exhibit    
Number   Description
 
   
99.1
  Press Release dated July 29, 2009.

 


 

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 hereunto duly authorized.
         
  SURMODICS, INC.
 
 
Date: July 29, 2009  /s/ Philip D. Ankeny    
  Philip D. Ankeny   
  Sr. Vice President and Chief Financial Officer   

 


 

         
EXHIBIT INDEX
     
Exhibit    
Number   Description
 
   
99.1
  Press Release dated July 29, 2009

 

exv99w1
Exhibit 99.1
FOR IMMEDIATE RELEASE
SurModics Reports Third Quarter 2009 Results
EDEN PRAIRIE, Minnesota — July 29, 2009 — SurModics, Inc. (Nasdaq: SRDX), a leading provider of drug delivery and surface modification technologies to the healthcare industry, today reported financial results for the third quarter ended June 30, 2009.
Third Quarter Summary:
  Financial highlights:
    Revenue of $18.2 million
 
    Operating income of $4.7 million
 
    Net income of $3.5 million
 
    Diluted EPS of $0.20
  Revenue by market:
    Therapeutic:
    Cardiovascular — $10.1 million
 
    Ophthalmology — $1.8 million
 
    Other Markets — $3.5 million
    Diagnostic — $2.8 million
  Cash and investments of $51.5 million; no debt
 
  Four new licenses with SurModics customers; achieved full year fiscal 2009 goal of 18 new license agreements
 
  New drug delivery license agreement for a drug-eluting balloon product
 
  Three new product classes introduced by our customers; achieved full year fiscal 2009 goal of 10 new product class introductions
“SurModics continues to make important progress both with our customer programs and extending our technology leadership in the healthcare industry,” said Bruce Barclay, president and CEO. “We are pleased to deliver another profitable quarter, particularly in light of the current economic environment and transitions in some of our revenue streams. Most significant of these transitions were the absence of royalty revenue from Abbott following the expiration of our lateral flow immunoassay technology patents and the termination of our agreement with Merck, which together contributed approximately $2.8 million of revenue in the second quarter and were not recurring in the third quarter. Excluding these non-recurring items from second quarter results, our total revenue in the third quarter increased slightly on a sequential basis. I am also encouraged that product

 


 

SurModics Third Quarter 2009 Results
Page 2
sales increased 7% on a sequential basis, and 33% compared with the first quarter. In addition, our continued focus on operating efficiency, including the restructuring actions we implemented earlier this year, has enabled us to reduce operating expenses, excluding product costs, by 25% year-over-year.”
“Importantly, we are continuing to make good progress against our published fiscal 2009 goals. After only three quarters, we have already achieved our full year fiscal 2009 objective of signing 18 license agreements, as well as our goal of 10 product class launches by our customers,” continued Barclay. “We are particularly excited about a new license agreement covering the use of SurModics’ drug delivery technology with a drug-eluting balloon product for the treatment of vascular disease. We are pleased to be partnering early in the creation of this potentially revolutionary technology.”
Revenue for the third quarter of fiscal 2009 was $18.2 million, compared with $24.3 million in the year-earlier period. Operating income was $4.7 million, compared with $7.2 million in the prior-year period. Net income was $3.5 million, compared with $4.8 million in the same period last year. Diluted earnings per share was $0.20, compared with $0.26 in the third quarter of fiscal 2008.
For the first nine months of fiscal 2009, revenue was $102.3 million, compared with $73.8 million in the year earlier period. Operating income was $53.5 million, compared with $21.9 million in the prior year period; net income was $34.8 million, compared with $15.6 million in the year earlier period; and diluted net income per share was $1.99, compared with $0.85 in the first nine months of fiscal 2008. Results for the first nine months of fiscal 2009 include the recognition of previously deferred revenue, as well as a milestone payment, totaling approximately $45 million, in connection with Merck’s termination of its agreement with SurModics.
“SurModics’ pipeline continues to represent significant potential,” added Barclay. As of June 30, 2009, SurModics’ customers had 105 licensed product classes generating royalty revenue, compared with 102 a year ago; the total number of licensed product classes not yet launched was 105, comparable with the prior-year period; and major non-licensed opportunities totaled 87, compared with 98 a year ago. In total, SurModics now has a portfolio of 192 potential commercial products in development diversified across multiple clinical indications and technology platforms.

 


 

SurModics Third Quarter 2009 Results
Page 3
SurModics’ cash and investment balance totaled $51.5 million as of June 30, 2009, with no debt. Operating cash flow for the third quarter was $7.9 million, compared with $13.7 million in the third quarter of fiscal 2008. For the first nine months of fiscal 2009, operating cash flow was $24.8 million, compared with $22.6 million in the first nine months of fiscal 2008.
“SurModics is in excellent financial condition,” said Phil Ankeny, senior vice president and chief financial officer. “The Company’s strong operating cash flow and healthy balance sheet with zero debt represent a significant competitive advantage in the current environment. In addition, we continue to demonstrate disciplined deployment of capital with a goal of enhancing shareholder value, principally in the areas of facilities-related and business development investments. The build-out of our development and cGMP manufacturing facility in Alabama is progressing smoothly, with encouraging customer interest, and continues to track to our timeline and budget. Additionally, SurModics is continuing to review business development opportunities that leverage our strong balance sheet to support our strategic objectives.”
Barclay concluded, “Given the significant decline in the global economy and the unexpected impact on our customers, SurModics believes that issues mainly related to timing will prevent the Company from achieving its high-level outlook for roughly flat revenue and diluted EPS on a non-GAAP basis in fiscal 2009 compared with fiscal 2008. On a near-term basis, we see a fairly wide range of potential outcomes for our financial results in the fourth quarter; however, at a minimum, we believe fourth quarter revenue will be approximately in line with third quarter revenue.”
Live Webcast
SurModics will host a webcast at 5:00 p.m. ET (4:00 p.m. CT) today to discuss the quarterly results. To access the webcast, go to the investor relations portion of the Company’s website at www.surmodics.com, and click on the third quarter webcast icon. If you do not have access to the Internet and want to listen to the audio by phone, dial 877-941-8605. A replay of the third quarter conference call will be available by dialing 800-406-7325 and entering conference call ID 4107594. The audio replay will be available beginning at 7:00 p.m. CT on Wednesday, July 29, until 7:00 p.m. CT on Wednesday, August 5.

 


 

SurModics Third Quarter 2009 Results
Page 4
About SurModics, Inc.
SurModics’ vision is to extend and improve the lives of patients through technology innovation. The Company partners with the world’s foremost medical device, pharmaceutical and life science companies to develop and commercialize innovative products that result in improved diagnosis and treatment for patients. Core offerings include: drug delivery technologies (coatings, microparticles, nanoparticles, and implants); surface modification coating technologies that impart lubricity, prohealing, and biocompatibility capabilities; and components for in vitro diagnostic test kits and specialized surfaces for cell culture and microarrays. SurModics is headquartered in Eden Prairie, Minnesota and its SurModics Pharmaceuticals subsidiary is located in Birmingham, Alabama. For more information about the Company, visit www.surmodics.com. The content of SurModics’ website is not part of this release or part of any filings the Company makes with the SEC.
Safe Harbor for Forward-Looking Statements
This press release contains forward-looking statements. Statements that are not historical or current facts, including statements about beliefs and expectations, such as our expectations about our pipeline, the potential of a drug-eluting balloon for the treatment of vascular disease, our ability to achieve our fiscal 2009 company goals, our continued growth, the build-out of our Alabama facility, and our performance in the near- and long-term, are forward-looking statements. Forward-looking statements involve inherent risks and uncertainties, and important factors could cause actual results to differ materially from those anticipated, including the following: (1) our reliance on third parties (including our customers and licensees) and their failure to successfully develop, obtain regulatory approval for, market and sell products incorporating our technologies may adversely affect our business operations, our ability to realize the full potential of our pipeline, and our ability to achieve our fiscal 2009 company goals; (2) costs or difficulties relating to the integration of the businesses of SurModics Pharmaceuticals and BioFX Laboratories, and the drug delivery assets and collaborative programs acquired from PR Pharmaceuticals, Inc., with SurModics’ business may be greater than expected and may adversely affect the Company’s results of operations and financial condition; (3) developments in the regulatory environment, as well as market and economic conditions, may adversely affect our business operations and profitability; and (4) other factors identified under “Risk Factors” in Part I, Item 1A of our Annual Report on Form 10-K for the fiscal year ended September 30, 2008, and updated in our subsequent reports filed with the SEC. These reports are available in the Investors section of our website at www.surmodics.com and at the SEC website at www.sec.gov. Forward-

 


 

SurModics Third Quarter 2009 Results
Page 5
looking statements speak only as of the date they are made, and we undertake no obligation to update them in light of new information or future events.
Contact
Phil Ankeny, Senior Vice President and Chief Financial Officer
(952) 829-2700

 


 

SurModics Third Quarter 2009 Results
Page 6
SurModics, Inc. and Subsidiaries
Condensed Consolidated Statements of Income

(In thousands, except per share data)
                                 
    Three Months Ended     Nine Months Ended  
    June 30,     June 30,  
    2009     2008     2009     2008  
    (Unaudited)     (Unaudited)  
Revenue
                               
Royalties and license fees
  $ 8,200     $ 13,587     $ 65,999     $ 40,574  
Product sales
    5,130       4,447       13,762       14,354  
Research and development
    4,856       6,242       22,566       18,884  
 
                       
Total revenue
    18,186       24,276       102,327       73,812  
 
                               
Operating costs and expenses
                               
Product costs
    1,988       1,773       5,341       5,902  
Research and development
    7,627       10,511       25,464       30,415  
Selling, general and administrative
    3,910       4,808       12,996       15,559  
Restructuring charges
                1,798        
Purchased in-process research and development
                3,200        
 
                       
Total operating expenses
    13,525       17,092       48,799       51,876  
 
                       
Income from operations
    4,661       7,184       53,528       21,936  
 
                               
Investment income
    794       626       1,796       3,530  
 
                       
Income before income taxes
    5,455       7,810       55,324       25,466  
Income tax provision
    (1,916 )     (3,010 )     (20,484 )     (9,913 )
 
                       
Net income
  $ 3,539     $ 4,800     $ 34,840     $ 15,553  
 
                       
 
                               
Basic net income per share
  $ 0.20     $ 0.27     $ 2.00     $ 0.86  
 
                       
 
                               
Diluted net income per share
  $ 0.20     $ 0.26     $ 1.99     $ 0.85  
 
                       
 
                               
Weighted average shares outstanding
                               
Basic
    17,356       18,073       17,458       18,058  
Diluted
    17,379       18,322       17,492       18,373  

 


 

SurModics Third Quarter 2009 Results
Page 7
SurModics, Inc. and Subsidiaries
Condensed Consolidated Balance Sheets

(In thousands)
                 
    June 30,     September 30,  
    2009     2008  
    (Unaudited)  
Assets
               
Current assets
               
Cash and short-term investments
  $ 21,905     $ 24,627  
Accounts receivable
    11,914       14,589  
Inventories
    3,109       2,651  
Other current assets
    1,632       4,642  
 
           
Total current assets
    38,560       46,509  
 
               
Property and equipment, net
    61,583       41,897  
Long-term investments
    29,598       47,351  
Intangibles, net
    18,233       16,870  
Goodwill
    21,070       18,001  
Other assets
    12,644       20,400  
 
           
 
               
Total assets
  $ 181,688     $ 191,028  
 
           
 
               
Liabilities and Stockholders’ Equity
               
Current liabilities *
  $ 7,706     $ 8,191  
Deferred revenue (current and long-term)
    1,762       37,578  
Other liabilities
    4,717       3,453  
 
           
 
               
Total stockholders’ equity
    167,503       141,806  
 
           
 
               
Total liabilities and stockholders’ equity
  $ 181,688     $ 191,028  
 
           
 
*   Current liabilities exclude current portion of deferred revenue.

 


 

SurModics Third Quarter 2009 Results
Page 8
SurModics, Inc. and Subsidiaries
Condensed Consolidated Statements of Cash Flows

(In thousands)
                 
    Nine Months Ended  
    June 30,  
    2009     2008  
    (Unaudited)  
Operating Activities:
               
Net income
  $ 34,840     $ 15,553  
Depreciation and amortization
    4,352       4,501  
Stock-based compensation
    4,988       7,181  
Purchased in-process research and development
    3,200        
Restructuring charges
    1,798        
Deferred taxes
    8,616       (4,339 )
Net other operating activities
    (104 )     (1,642 )
Change in operating assets and liabilities:
               
Accounts receivable
    2,675       (8,598 )
Accounts payable and accrued liabilities
    (3,261 )     (369 )
Income taxes
    3,302       (3,945 )
Deferred revenue
    (35,816 )     13,151  
Net change in other operating assets and liabilities
    179       1,107  
 
           
 
               
Net cash provided by operating activities
    24,769       22,600  
 
           
 
               
Investing Activities:
               
Net purchases of property and equipment
    (21,660 )     (16,849 )
Business acquisition
    (8,585 )     (2,996 )
Cash restricted for land purchase
          (1,640 )
Collection of notes receivable
          5,870  
Net other investing activities
    11,122       (2,594 )
 
           
 
               
Net cash used in investing activities
    (19,123 )     (18,209 )
 
           
Financing Activities:
               
Issuance of common stock
    655       2,955  
Purchase of common stock to fund employee taxes
    (457 )     (1,495 )
Repurchase of common stock
    (14,998 )     (6,717 )
Net other financing activities
    (478 )     712  
 
           
 
               
Net cash used in financing activities
    (15,278 )     (4,545 )
 
           
 
               
Net change in cash and cash equivalents
    (9,632 )     (154 )
 
               
Cash and cash equivalents
               
Beginning of period
    15,376       13,812  
 
           
End of period
  $ 5,744     $ 13,658