EX-99.1 2 c54465exv99w1.htm EX-99.1 exv99w1
Exhibit 99.1
FOR IMMEDIATE RELEASE
SurModics Reports Fourth Quarter and
Fiscal Year 2009 Results
Twelfth Consecutive Year of Record Revenue Since IPO
EDEN PRAIRIE, Minnesota — November 4, 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 fourth quarter and fiscal year ended September 30, 2009.
Fiscal Year 2009 Summary:
  GAAP results:
  o   Record revenue of $121.5 million, up 25%
 
  o   Operating income of $57.5 million
 
  o   Net income of $37.6 million
 
  o   Diluted EPS of $2.15
 
  o   Revenue by market:
  §   Therapeutic:
    Cardiovascular — $39.8 million, down 16%
 
    Ophthalmology — $52.1 million, up 408%
 
    Other Markets — $13.1 million, down 27%
  §   Diagnostic — $16.5 million, down 23%
  Non-GAAP results:
  o   Revenue of $86.8 million, down 22%
 
  o   Operating income of $27.7 million
 
  o   Net income of $18.7 million
 
  o   Diluted EPS of $1.07
  Operating cash flow of $31.3 million
 
  Cash and investments of $47.9 million, with no debt
 
  Achieved five of seven 2009 goals by fiscal year-end and a sixth shortly thereafter:
  o   Executed a total of 22 new licenses with SurModics customers
 
  o   Executed 2 new customer licenses at SurModics Pharmaceuticals
 
  o   Executed 2 new customer licenses using SurModics drug delivery technology outside ophthalmology
 
  o   Introduction of 12 new licensed product classes by our customers
 
  o   Returned over one-third of our operating cash flow to shareholders with the repurchase of $15 million of SurModics stock; and
 
  o   Achieved a sixth goal on October 5th with the execution of the Ophthalmic License and Development Agreement with Roche and Genentech regarding Lucentis™ (ranibizumab injection)

 


 

Fourth Quarter Summary:
  Financial highlights:
  o   Revenue of $19.2 million, down 17% year-over-year; up 6% sequentially
 
  o   Operating income of $4.0 million
 
  o   Net income of $2.7 million
 
  o   Diluted EPS of $0.16
 
  o   Results include approximately $0.5 million of one-time expenses
 
  o   Revenue by market:
  §   Therapeutic:
    Cardiovascular — $9.8 million, down 12%
 
    Ophthalmology — $1.9 million, down 29%
 
    Other Markets — $2.9 million, down 41%
  §   Diagnostic — $4.6 million, up 2%
  o   Operating cash flow of $6.6 million
  4 new licenses with SurModics customers, including 2 new licenses at SurModics Pharmaceuticals
 
  2 new product classes introduced by our customers
“While SurModics experienced a challenging year in fiscal 2009, as did many companies in this difficult economic environment, through the hard work of our talented employees we achieved significant progress against our strategic initiatives, allowing us to better withstand the economic turbulence and ultimately thrive when conditions improve,” said Bruce Barclay, president and CEO. “The new ophthalmic license and development agreement we signed last month with Genentech and Roche for the development and commercialization of a sustained drug delivery formulation of Lucentis, and potentially other compounds, confirms the value of our technologies and reinforces our optimism for the future. This historic agreement also marks the third license agreement signed by our SurModics Pharmaceuticals unit in the last three months, demonstrating the important progress we are making with our business model, as well as our success in licensing our proprietary drug delivery technologies to pharma and biotech customers.”
“There are numerous additional examples of the progress we made in fiscal 2009,” continued Barclay. “Our overall cardiovascular franchise is strengthening, as innovative device manufacturers continue to choose our technology for their higher value proprietary products, such as drug-eluting balloons, percutaneous valves, stent grafts, and drug-eluting stents. Excluding Cypher related revenue, cardiovascular revenue increased sequentially in the fourth quarter. In addition, our ophthalmology business, of which the Genentech program is just one part, is making exciting progress, and we

 


 

SurModics Fourth Quarter and Fiscal Year 2009 Results
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continue to have multiple customer supported projects in development. Also, several of our highest potential programs utilizing SurModics’ technologies continued to successfully advance in clinical studies, including our SynBiosys™ biodegradable polymer, our Finale™ Prohealing coating, and our I-vation™ TA (triamcinolone acetonide) intravitreal implant. Moreover, the innovation we apply to our customers’ commercial products and SurModics’ technology pipeline remains a consistent source of strength and optimism. At year end, we had a total of 291 current and potential commercial products diversified across approximately a dozen different clinical indications.”
“Importantly, SurModics’ successful technology development is a key component of the Company’s strategic initiatives. A central element of our strategy is broadening the technologies we make available to our customers through both internal R&D and external acquisitions. Our November 2008 purchase of certain assets from PR Pharmaceuticals is an example of this initiative. Another strategic priority is diversifying our revenue streams. We have made significant progress on this front, as the percentage of SurModics’ revenue derived from Johnson & Johnson including the Cypher® drug-eluting stent has decreased significantly. In fiscal 2009, J&J constituted 11% of total revenue, down from 20% last year and a high of 52% in fiscal 2004. Further, we continued to protect and enhance core businesses that generate recurring revenue, including product sales, which grew each quarter throughout the year to a high in the fourth quarter, with improved product gross margins compared with 2008. Finally, as a benefit of our prudent expense management, we increased our investment in our business and are near completion of our world class cGMP facility, which will be utilized for our program with Genentech, among others,” added Barclay.
Revenue for the fourth quarter of fiscal 2009 was $19.2 million, compared with $23.2 million in the year-earlier period. Operating income was $4.0 million, compared with $5.3 million in the prior-year period. Net income was $2.7 million, compared with a net loss of $0.8 million in the same period last year. Diluted earnings per share was $0.16, compared with ($0.05) in the fourth quarter of fiscal 2008. Results for the fourth quarter of fiscal 2008 include a $4.3 million (or approximately $0.24 per diluted share) one-time, non-cash impairment loss on the Company’s investment in OctoPlus.
Fiscal 2009 revenue was a record $121.5 million, a 25% increase compared with fiscal 2008 revenue of $97.1 million. The Company reported operating income of $57.5 million, compared with $27.3 million in the prior year; net income of $37.6 million, compared with $14.7 million last year; and diluted net income per share of $2.15, compared with $0.80

 


 

SurModics Fourth Quarter and Fiscal Year 2009 Results
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in fiscal 2008. On a non-GAAP basis, for fiscal 2009, total revenue was $86.8 million, operating income was $27.7 million, net income was $18.7 million, and diluted net income per share was $1.07. On a non-GAAP basis, for fiscal 2008, total revenue was $111.2 million, operating income was $41.4 million, net income was $27.7 million, and diluted net income per share was $1.51. Non-GAAP results for fiscal 2009 exclude the recognition of previously deferred revenue totaling approximately $35 million, in connection with Merck’s termination of its agreement with SurModics.
SurModics’ cash and investment balance totaled $47.9 million as of September 30, 2009, with no debt. Operating cash flow for the fourth quarter was $6.6 million, compared with $16.2 million in the fourth quarter of fiscal 2008. For fiscal year 2009, operating cash flow was $31.3 million, compared with $39.8 million in fiscal year 2008.
“Given our optimism for the future, we continued to leverage our strong balance sheet and invest in our business in fiscal 2009, as we enhanced the Company’s positioning for profitable long-term growth,” said Phil Ankeny, senior vice president and chief financial officer. “We are in excellent financial condition as a result of our strong operating cash flow and healthy balance sheet with zero debt. In addition, we maintained our disciplined deployment of capital with a goal of enhancing shareholder value, principally in the areas of facilities-related and corporate development investments, as well as share repurchases.”
Live Webcast
SurModics will host a webcast at 5:00 p.m. ET (4:00 p.m. CT) today to discuss the quarterly and full year results. To access the webcast, go to the investor relations portion of the Company’s website at www.surmodics.com, and click on the webcast icon. If you do not have access to the Internet and want to listen to the audio by phone, dial 800-762-8779. A replay of the fourth quarter and fiscal year 2009 conference call will be available by dialing 800-406-7325 and entering conference call ID 4178397. The audio replay will be available beginning at 7:00 p.m. CT on Wednesday, November 4, until 7:00 p.m. CT on Wednesday, November 11.
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

 


 

SurModics Fourth Quarter and Fiscal Year 2009 Results
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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 ability to withstand economic turbulence and ultimately thrive when conditions improve, our ability to successfully develop and commercialize our technologies, our ability to achieve our company goals, our ability to successfully implement our business model and grow, the build-out and future utilization of our Alabama facility, and our performance in the near- and long-term, including our positioning for profitable long-term growth, 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) realizing the full potential benefits of the Company’s agreement with Genentech requires the development of new products and applications of technology, and the successful build-out of our Alabama facility in compliance with applicable regulatory requirements; (2) 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 company goals; (3) 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; (4) developments in the regulatory environment, as well as market and economic conditions, may adversely affect our business operations and profitability; and (5) 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.

 


 

SurModics Fourth Quarter and Fiscal Year 2009 Results
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Forward-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.
Use of Non-GAAP Financial Information
In addition to reporting financial results in accordance with generally accepted accounting principles, or GAAP, SurModics is reporting non-GAAP financial results including non-GAAP revenue, non-GAAP net income and non-GAAP diluted net income per share. We believe that these non-GAAP measures provide meaningful insight into our operating performance as it relates to our Merck agreement accounting treatment and provide an alternative perspective of our results of operations. We use these non-GAAP measures to assess our operating performance and to determine payout under our executive compensation programs. We believe that presentation of these non-GAAP measures allows investors to review our results of operations from the same perspective as management and our board of directors. We believe these non-GAAP measures facilitate investors’ analysis and comparisons of our current results of operations and provide insight into the prospects of our future performance. We also believe that the non-GAAP measures are useful to investors because they provide supplemental information that research analysts frequently use. The method we use to produce non-GAAP results is not in accordance with GAAP and may differ from the methods used by other companies. These non-GAAP results should not be regarded as a substitute for corresponding GAAP measures but instead should be utilized as a supplemental measure of operating performance in evaluating our business. Non-GAAP measures do have limitations in that they do not reflect certain items that may have a material impact upon our reported financial results. As such, these non-GAAP measures should be viewed in conjunction with both our financial statements prepared in accordance with GAAP and the reconciliation of the supplemental non-GAAP financial measures to the comparable GAAP results provided for each period presented, which are attached to this release.
Contact
Phil Ankeny, Senior Vice President and Chief Financial Officer
(952) 829-2700

 


 

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SurModics, Inc. and Subsidiaries
Condensed Consolidated Statements of Operations
(In thousands, except per share data)
                                 
    Three Months Ended     Year Ended  
    September 30,     September 30,  
    2009     2008     2009     2008  
    (Unaudited)     (Unaudited)  
Revenue
                               
Royalties and license fees
  $ 9,465     $ 11,214     $ 75,464     $ 51,788  
Product sales
    5,571       5,698       19,333       20,052  
Research and development
    4,171       6,327       26,737       25,211  
 
                       
Total revenue
    19,207       23,239       121,534       97,051  
 
Operating costs and expenses
                               
Product costs
    2,167       2,574       7,508       8,476  
Customer research and development
    2,936       4,473       13,183       19,187  
Other research and development
    5,962       5,610       21,179       21,311  
Selling, general and administrative
    4,204       5,257       17,200       20,816  
Restructuring charges
    (35 )           1,763        
Purchased in-process research and development
                3,200        
 
                       
Total operating expenses
    15,234       17,914       64,033       69,790  
 
                       
Income from operations
    3,973       5,325       57,501       27,261  
 
                               
Investment income
    227       415       2,023       3,945  
Impairment loss on investment
          (4,314 )           (4,314 )
 
                       
Income before income taxes
    4,200       1,426       59,524       26,892  
 
                               
Income tax provision
    (1,490 )     (2,240 )     (21,974 )     (12,153 )
 
                       
Net income (loss)
  $ 2,710     $ (814 )   $ 37,550     $ 14,739  
 
                       
 
                               
Basic net income (loss) per share
  $ 0.16     $ (0.05 )   $ 2.15     $ 0.82  
 
                       
 
                               
Diluted net income (loss) per share
  $ 0.16     $ (0.05 )   $ 2.15     $ 0.80  
 
                       
 
                               
Weighted average shares outstanding
                               
Basic
    17,367       17,898       17,435       18,026  
Diluted
    17,404       17,898       17,469       18,330  
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SurModics, Inc. and Subsidiaries
Condensed Consolidated Balance Sheets
(In thousands)
                 
    September 30,     September 30,  
    2009     2008  
    (Unaudited)  
Assets
               
Current assets
               
Cash and short-term investments
  $ 20,568     $ 24,627  
Accounts receivable
    11,320       14,589  
Inventories
    3,330       2,651  
Other current assets
    1,796       4,642  
 
           
Total current assets
    37,014       46,509  
 
               
Property and equipment, net
    66,915       41,897  
Long-term investments
    27,300       47,351  
Intangibles, net
    17,458       16,870  
Goodwill
    21,070       18,001  
Other assets
    15,805       20,400  
 
           
 
               
Total assets
  $ 185,562     $ 191,028  
 
           
 
Liabilities and Stockholders’ Equity
               
Current liabilities *
  $ 7,078     $ 8,191  
 
               
Deferred revenue (current and long-term)
    1,528       37,578  
 
               
Other liabilities
    4,584       3,453  
 
               
Total stockholders’ equity
    172,372       141,806  
 
           
 
               
Total liabilities and stockholders’ equity
  $ 185,562     $ 191,028  
 
           
 
*   Current liabilities exclude current portion of deferred revenue.
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SurModics, Inc. and Subsidiaries
Condensed Consolidated Statements of Cash Flows
(In thousands)
                 
    Year Ended  
    September 30,  
    2009     2008  
    (Unaudited)  
Operating Activities:
               
Net income
  $ 37,550     $ 14,739  
Depreciation and amortization
    5,912       6,071  
Stock-based compensation
    6,853       9,652  
Purchased in-process research and development
    3,200        
Restructuring charges
    1,763        
Impairment loss on investment
          4,314  
Net other operating activities
    8,670       (3,946 )
Change in operating assets and liabilities:
               
Accounts receivable
    3,269       1,548  
Accounts payable and accrued liabilities
    (2,387 )     (264 )
Income taxes
    2,656       (5,003 )
Deferred revenue
    (36,050 )     11,452  
Net change in other operating assets and liabilities
    (115 )     1,259  
 
           
 
               
Net cash provided by operating activities
    31,321       39,822  
 
           
 
               
Investing Activities:
               
Net purchases of property and equipment
    (29,364 )     (23,834 )
Business acquisition
    (8,585 )     (3,219 )
Collection of note receivable
          5,870  
Net other investing activities
    18,377       (5,326 )
 
           
 
               
Net cash used in investing activities
    (19,572 )     (26,509 )
 
           
 
               
Financing Activities:
               
Issuance of common stock
    679       3,037  
Purchase of common stock to fund employee taxes
    (568 )     (1,674 )
Repurchase of common stock
    (14,998 )     (13,971 )
Net other financing activities
    (602 )     859  
 
           
 
               
Net cash used in financing activities
    (15,489 )     (11,749 )
 
           
 
               
Net change in cash and cash equivalents
    (3,740 )     1,564  
 
               
Cash and cash equivalents
               
Beginning of year
    15,376       13,812  
 
           
End of year
  $ 11,636     $ 15,376  
 
           
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SurModics, Inc. and Subsidiaries
Supplemental Non-GAAP Information
For the Year Ended September 30, 2009
(in thousands, except per share data)
(Unaudited)
                                         
            Merck Agreement              
            Adjustments              
    As     Deferred                    
    Reported     Revenue     Billed     Other     Adjusted  
    GAAP (1)     Recognized     Activity     Adjustments     Non-GAAP (2)  
Revenue:
                                       
Royalties and license fees
  $ 75,464     $ (28,578 )(3)   $ (4)           $ 46,886  
Product sales
    19,333                               19,333  
Research and development
    26,737       (6,200 )(3)     (4)             20,537  
 
                               
Total revenue
  $ 121,534     $ (34,778 )   $             $ 86,756  
 
                               
 
                                       
Income from operations
  $ 57,501     $ (34,778 )   $     $ 4,963     $ 27,686  
 
                             
 
                                       
Net income
  $ 37,550     $ (21,939 )(5)   $ (5)   $ 3,131 (5)   $ 18,742  
 
                             
 
                                       
Diluted net income per share (6)
  $ 2.15                             $ 1.07  
 
                                   
                                         
    Balance at     Deferred                     Balance at  
    September     Revenue     Billed             September  
    30, 2008     Recognized     Activity             30, 2009  
Merck deferred revenue (7)
  $ 34,778     $ (34,778 )   $             $  
 
                               
 
(1)   Reflects operating results in accordance with U.S. generally accepted accounting principles (GAAP). GAAP revenue includes a $9 million milestone payment and a $1.2 million research and development payment from Merck which were billed and recognized in the period.
 
(2)   Adjusted Non-GAAP amounts exclude the $34,778 of previously deferred revenue recognized in the period associated with the termination of the Merck agreement under GAAP; and exclude the restructuring charges of $1,763 and in-process research and development charge of $3,200 associated with the acquisition of PR Pharmaceuticals, Inc. assets.
 
(3)   Reflects recognition of revenue for the Merck agreement in accordance with GAAP for the period presented that previously had been deferred.
 
(4)   Reflects amounts billed and deferred under the Merck agreement for the period presented.
 
(5)   Reflects the after tax impact of the adjustments utilizing the Company’s effective tax rate for the period presented.
 
(6)   Diluted net income per share is calculated using the diluted weighted average shares outstanding for the period presented.
 
(7)   Reflects the activity for the period presented in the deferred revenue balance sheet accounts associated with the Merck agreement. This agreement terminated in December 2008.
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SurModics, Inc. and Subsidiaries
Supplemental Non-GAAP Information
For the Year Ended September 30, 2008
(in thousands, except per share data)
(Unaudited)
                                         
                           
            Merck Agreement                
    As     Adjustments             Adjusted  
    Reported     Revenue     Billed     Other     Non-GAAP  
    GAAP (1)     Recognized     Activity     Adjustments     (2)  
Revenue:
                                       
Royalties and license fees
  $ 51,788     $ (2,109 )(3)   $ 11,000 (4)           $ 60,679  
Product sales
    20,052                               20,052  
Research and development
    25,211     $ (1,073 )(3)     6,336 (4)             30,474  
 
                               
 
                                       
Total revenue
  $ 97,051     $ (3,182 )   $ 17,336             $ 111,205  
 
                               
 
                                       
Income from operations
  $ 27,261     $ (3,182 )   $ 17,336     $     $ 41,415  
 
                             
 
                                       
Net income
  $ 14,739     $ (1,943 )(5)   $ 10,585 (5)   $ 4,314 (6)   $ 27,695  
 
                             
 
                                       
Diluted net income per share (7)
  $ 0.80                             $ 1.51  
 
                                   
                                         
    Balance at                             Balance at  
    September     Revenue     Billed             September  
    30, 2007     Recognized     Activity             30, 2008  
Merck deferred revenue (8)
  $ 20,624     $ (3,182 )   $ 17,336             $ 34,778  
 
                               
 
(1)   Reflects operating results in accordance with U.S. generally accepted accounting principles (GAAP).
 
(2)   Adjusted Non-GAAP amounts exclude the revenue recognized in the period associated with the Merck agreement under GAAP and include amounts billed associated with the Merck agreement; and exclude the impairment loss on investment.
 
(3)   Reflects recognition of revenue for the Merck agreement in accordance with GAAP for the period presented.
 
(4)   Reflects amounts billed under the Merck agreement for the period presented.
 
(5)   Reflects the after tax impact of the adjustments utilizing the Company’s effective tax rate for the period presented.
 
(6)   Reflects adjustment for the impairment loss on our investment in OctoPlus of $4,314. The impairment loss does not generate a tax benefit.
 
(7)   Diluted net income per share is calculated using the diluted weighted average shares outstanding for the period presented.
 
(8)   Reflects the activity for the period presented in the deferred revenue balance sheet account associated with the Merck agreement.
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