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Table of Contents

 
 
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
November 6, 2007
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))
 
 

 


TABLE OF CONTENTS

Item 2.02. Results of Operations And Financial Condition.
Item 9.01. Financial Statements and Exhibits.
SIGNATURES
EXHIBIT INDEX
Press Release


Table of Contents

Item 2.02. Results of Operations And Financial Condition.
     On November 6, 2007, SurModics, Inc. issued a press release announcing the results for the quarter and fiscal year ended September 30, 2007. 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.
     (a) Financial Statements: None.
     (b) Pro forma financial information: None.
     (c) Shell company transactions: None.
     (d) Exhibits: 99.1 Press Release dated November 6, 2007.

 


Table of Contents

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: November 6, 2007  /s/ Philip D. Ankeny    
  Philip D. Ankeny   
  Chief Financial Officer   
 

 


Table of Contents

EXHIBIT INDEX
     
Exhibit    
Number   Description
99.1
  Press Release dated November 6, 2007.

 

exv99w1
 

EXHIBIT 99.1
FOR IMMEDIATE RELEASE
SurModics Reports Fourth Quarter and Fiscal Year 2007 Results
Tenth Consecutive Year of Record Revenue Since 1998 IPO
EDEN PRAIRIE, Minnesota — November 6, 2007 — SurModics, Inc. (Nasdaq: SRDX), a leading provider of surface modification and drug delivery technologies to the healthcare industry, today reported financial results for the fourth quarter and fiscal year ended September 30, 2007.
Fourth Quarter Highlights:
  Received $20 million payment from Merck for the up front license fee in connection with the Research and Collaboration Agreement, signed in June
 
  Completed acquisition of Brookwood Pharmaceuticals, which resulted in a one-time in-process research and development (IPR&D) charge of $15.6 million
 
  Completed acquisition of BioFX Laboratories
 
  Record revenue of $21.3 million, up 21% year-over-year
 
  Record operating cash flow of $27.1 million
 
  Record non-CYPHER-related revenue, up 55% year-over-year and up 34% sequentially
 
  13th consecutive quarter of growth in non-CYPHER revenue
 
  Record revenue and strong year-over-year growth in “In Vitro” and “Hydrophilic and Other” operating segments
 
  Revenue growth in all three operating segments:
    Hydrophilic and Other — up 24%
 
    In Vitro — up 41%
 
    Drug Delivery — up 7%
  GAAP results:
    Operating loss of $13.8 million
 
    Net loss of $13.9 million
 
    Diluted EPS of ($0.78)
  Non-GAAP results (excluding one-time IPR&D charge):
    Adjusted operating income of $1.8 million
 
    Adjusted net income of $1.7 million
 
    Adjusted diluted EPS of $0.09
  Six new licenses signed with SurModics customers
 
  Four new product classes launched by our customers
Fiscal Year 2007 Highlights:
  Record revenue of $73.2 million, up 5% from fiscal 2006

 


 

SurModics Fourth Quarter and Fiscal Year 2007 Results
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  Record operating cash flow of $50.7 million
 
  Record non-CYPHER-related revenue, up 30%
 
  Record revenue in “In Vitro” and “Hydrophilic and Other” operating segments
 
  GAAP results:
    Operating income of $9.9 million
 
    Net income of $3.3 million
 
    Diluted EPS of $0.18
  Non-GAAP results (excluding one-time IPR&D charge):
    Adjusted operating income of $25.5 million
 
    Adjusted net income of $18.9 million
 
    Adjusted diluted EPS of $1.04
  Record 27 new licenses signed with SurModics customers
 
  Record 17 new product classes launched by our customersS.
Fiscal year 2007 was a strong year for SurModics, representing our tenth consecutive year of record revenue since our IPO in 1998,” said Bruce Barclay, President and CEO. “We achieved record revenue of $73.2 million in fiscal 2007, even though only a small amount of the cash we received from Merck was reflected in fourth quarter revenue. Three years ago, we outlined a new strategy and seven-point revenue growth plan, with the goal of maintaining sustainable growth well into the future. A key element of this strategy is diversifying our revenue streams. We believe that the fruits of our efforts have really materialized in fiscal 2007. The percentage of revenue coming from the Johnson & Johnson Cypher® drug eluting stent has decreased significantly thanks in large part to strong growth in the rest of our business. Every year, we disclose the revenue attributable to J&J — which comes mostly from the Cypher stent, but also other J&J products that incorporate SurModics technologies. In fiscal 2007, J&J constituted 33% of total revenue. This figure is down from 47% of total revenue in fiscal 2006, and is substantially less than its peak at 52% in fiscal 2004. In the three years since then, our non-J&J revenue — the rest of our business — has more than doubled, growing at a 27% compound annual growth rate.”
“Perhaps more importantly,” continued Barclay, “we have positioned the company for greater diversification and growth going forward with the signing of three significant agreements — our new ophthalmology joint development and license agreement with Merck, our acquisition of Brookwood Pharmaceuticals, and our acquisition of BioFX Laboratories. The Merck agreement confirms the magnitude of our opportunity in ophthalmology. Our Brookwood Pharmaceuticals acquisition adds new technology

 


 

SurModics Fourth Quarter and Fiscal Year 2007 Results
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capabilities and accelerates our exposure to the pharma and biotech markets. The acquisition of BioFX adds additional synergistic products to our offerings for in vitro diagnostic customers.”
“Lastly, we have had many significant operational and technical accomplishments in fiscal 2007,” continued Barclay. “We have generated compelling data in connection with our various biodegradable polymer technologies for site specific drug delivery applications. Apollo Therapeutics, the stent development unit of Paragon IP, presented very encouraging pre-clinical data at the recent TCT meeting for their Protex™ prohealing stent, which incorporates our Finale™ prohealing coating technology. We continue to believe our Finale coating stands to be a potentially significant technology to address late stent thrombosis.”
While total SurModics revenue from the Cypher stent decreased 32% in the fourth quarter compared with the prior year period, the rest of our business continued its strong growth trend, with non-Cypher-related revenue growing 55% from the year earlier period and 34% sequentially. The gain marks the 13th consecutive quarter of non-Cypher revenue growth. “Our ability to generate record revenue for the quarter in the face of this decline further highlights the strength of our unique and evolving business model and the value of our broad portfolio of royalty bearing products,” commented Barclay.
Revenue for the fourth quarter of fiscal year 2007 was $21.3 million, an increase of 21% from $17.6 million in the fourth quarter of fiscal year 2006. The company reported an operating loss of $13.8 million, compared with operating income of $9.2 million in the prior-year period; a net loss of $13.9 million, compared with net income of $6.3 million in the same period last year; and diluted earnings (loss) per share of ($0.78), compared with $0.34 in the fourth quarter of fiscal 2006. Results include a $15.6 million one-time charge for in-process research and development (IPR&D) in connection with the acquisition of Brookwood Pharmaceuticals, Inc. Excluding this charge, non-GAAP results were as follows: adjusted operating income of $1.8 million; adjusted net income of $1.7 million; and adjusted diluted earnings per share of $0.09. Operating expenses for the fourth quarter include approximately $7.4 million of incentive compensation related charges, the majority of which are non-cash. In addition, the operations of Brookwood and BioFX added to the base of total operating expenses. Finally, the company has been fortifying its technical team and capabilities to better support its customers — today and in the future.

 


 

SurModics Fourth Quarter and Fiscal Year 2007 Results
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Fiscal year 2007 revenue was a record $73.2 million, a 5% increase over fiscal year 2006 revenue of $69.9 million. The company reported operating income of $9.9 million, compared with $36.2 million in the prior year; net income of $3.3 million, compared with $20.3 million last year; and diluted earnings per share of $0.18, compared with $1.09 in fiscal 2006. Excluding the IPR&D charge, non-GAAP results were as follows: adjusted operating income of $25.5 million; adjusted net income of $18.9 million; and adjusted diluted earnings per share of $1.04.
The company’s pipeline continues to represent significant potential. SurModics signed six new licenses in the fourth quarter, bringing the fiscal year total to a record 27, significantly ahead of the 21 new licenses SurModics signed in fiscal year 2006. During the fiscal year, SurModics’ customers introduced 17 new product classes, up from 15 in fiscal year 2006. At September 30, a total of 100 customer product classes were on the market generating royalty revenue, compared with 83 in the prior-year period; the total number of licensed products not yet launched was 94, compared with 84 a year ago; and major non-licensed opportunities stood at 75, compared with 69 a year ago. In total, the company now has 169 potential commercial products in development. These figures do not include projects at Brookwood Pharmaceuticals, where there are an additional 31 projects in development.
Operating cash flow for fiscal 2007 was $50.7 million, a 44% increase compared with $35.3 million for fiscal 2006. For the fourth quarter of fiscal 2007, operating cash flow was a record $27.1 million.
SurModics’ cash and investment balance was $70.2 million as of September 30, 2007, compared with $106.6 million as of September 30, 2006. “We were very active in fiscal 2007 in the deployment of capital with a goal of enhancing shareholder value,” said Phil Ankeny, Senior Vice President and Chief Financial Officer. “We are pleased to have completed our $35 million share repurchase program during the year. In the full repurchase program, we retired in excess of one million shares at an average price of $34.76 per share, facilitating a reduction of approximately 5% in total shares outstanding. We also completed the acquisitions of Brookwood Pharmaceuticals and BioFX Laboratories. Despite having used over $86 million in these various initiatives, our cash and investment balance is still over $70 million. We believe our activities and

 


 

SurModics Fourth Quarter and Fiscal Year 2007 Results
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accomplishments in fiscal 2007 have strengthened our ability to build long-term shareholder value.”
Live Webcast
SurModics will host a webcast at 5:00 p.m. ET (4:00 p.m. CT) today to discuss the quarterly and fiscal year results. To access the webcast, go to the investor relations portion of the company’s web site, 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, dial 800-867-0448. A replay of the fourth quarter conference call will be available by dialing 800-405-2236 and entering conference call ID 11099728. The audio replay will be available beginning at 6:00 p.m. CT on Tuesday, November 6, until 6:00 p.m. CT on Tuesday, November 13.
About SurModics, Inc.
SurModics, Inc. is a leading provider of surface modification and drug delivery technologies to the healthcare industry. SurModics partners with the world’s foremost medical device, pharmaceutical and life science companies to develop and commercialize innovative products that result in better patient outcomes. Core offerings include: drug delivery technologies (coatings, microparticles, 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. Collaborative efforts include a sustained drug delivery system in human trials for treatment of retinal disease and the drug delivery polymer matrix on the first-to-market drug-eluting coronary stent. SurModics is headquartered in Eden Prairie, Minnesota and its Brookwood Pharmaceuticals subsidiary is located in Birmingham, Alabama. For more information about the company, visit www.surmodics.com. The content of SurModics’ web site 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, are forward looking statements. These forward looking statements cover, among other things, statements regarding diversifying and increasing SurModics’ revenue streams, the potential importance of the company’s Finale coating technology and statements regarding the company’s pipeline. Forward looking statements involve inherent risks and

 


 

SurModics Fourth Quarter and Fiscal Year 2007 Results
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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 Merck requires the development of new products and applications of technology (2) costs or difficulties relating to the integration of the businesses of Brookwood Pharmaceuticals and BioFX Laboratories with SurModics’ business may be greater than expected and may adversely affect the company’s results of operations and financial condition; (3) the potential commercial value of the company’s Finale coating technology may take longer than anticipated to achieve or may not be achieved in its entirety or at all; (4) developments in the regulatory environment, as well as market and economic conditions, may adversely affect the business and profitability of SurModics and its ability to realize the potential of its pipeline; 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, 2006, and updated in our subsequent reports filed with the SEC. These reports are available in the Investors section of our web site at www.surmodics.com and at the SEC web site at www.sec.gov. 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.
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,  
    2007     2006     2007     2006  
    (Unaudited)     (Unaudited)  
Revenue:
                               
Royalties and license fees
  $ 13,015     $ 13,495     $ 52,679     $ 53,008  
Product sales
    4,489       3,258       13,543       11,172  
Research & development
    3,795       820       6,942       5,704  
 
                       
Total revenue
    21,299       17,573       73,164       69,884  
 
                               
Operating expenses:
                               
Product
    2,188       959       5,584       3,399  
Research & development
    11,341       5,456       28,465       20,391  
Selling, general & administrative
    6,010       1,991       13,643       9,931  
Purchased in-process R&D
    15,573             15,573       --  
 
                       
Total operating expenses
    35,112       8,406       63,265       33,721  
 
                       
Income (loss) from operations
    (13,813 )     9,167       9,899       36,163  
 
                               
Investment income
    1,066       1,271       4,768       4,053  
Impairment loss on investment
                      (4,651 )
 
                       
Income (loss) before income taxes
    (12,747 )     10,438       14,667       35,565  
Income tax provision
    (1,159 )     (4,144 )     (11,321 )     (15,231 )
 
                       
Net income (loss)
    ($13,906 )   $ 6,294     $ 3,346     $ 20,334  
 
                       
 
                               
Basic net income (loss) per share
    ($0.78 )   $ 0.34     $ 0.19     $ 1.10  
 
                       
 
                               
Diluted net income (loss) per share
    ($0.78 )   $ 0.34     $ 0.18     $ 1.09  
 
                       
 
                               
Weighted average shares outstanding
                               
Basic
    17,898       18,628       18,033       18,527  
Diluted
    17,898       18,777       18,217       18,719  

 


 

SurModics Fourth Quarter and Fiscal Year 2007 Results
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SurModics, Inc. and Subsidiaries
Comparative Analysis of Earnings
(In thousands, except per share data)
                                 
    Three Months Ended     Year Ended  
    September 30,     September 30,  
    2007     2006     2007     2006  
    (Unaudited)     (Unaudited)  
 
Net Income (Loss) (GAAP)
    ($13,906 )   $ 6,294     $ 3,346     $ 20,334  
 
                               
Add: Purchased In-Process R&D (1)
  $ 15,573           $ 15,573       --  
Add: Impairment Loss on Investment (2)
                      4,651  
 
                               
Adjusted net income
  $ 1,667     $ 6,294     $ 18,919     $ 24,985  
 
                       
 
                               
Diluted Net Income (Loss) per Share (GAAP)
    ($0.78 )   $ 0.34     $ 0.18     $ 1.09  
 
                               
Add: Net Impact of Purchased In-Process R&D
  $ 0.87           $ 0.86       --  
 
                               
Add: Net Impact of Impairment Loss on
                    $ 0.25  
Investment
                               
 
                               
Adjusted Diluted Net Income per Share
  $ 0.09     $ 0.34     $ 1.04     $ 1.34  
 
                       
Notes: (1) Reflects one-time charge for purchased in-process research and development in connection with the Company’s acquisition of Brookwood Pharmaceuticals, Inc., which was completed during the fourth quarter of fiscal 2007.
           (2) Reflects non-cash impairment loss on the Company’s investment in Novocell, Inc., which was recorded in the second quarter of fiscal 2006.

 


 

SurModics Fourth Quarter and Fiscal Year 2007 Results
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SurModics, Inc. and Subsidiaries
Condensed Consolidated Balance Sheets
(In thousands)
                 
    September 30,     September 30,  
    2007     2006  
    (Unaudited)          
Assets
               
 
               
Current assets:
               
Cash & investments
  $ 26,308     $ 58,813  
Accounts receivable
    16,138       14,493  
Inventories
    2,497       952  
Other current assets
    2,952       1,838  
 
           
Total current assets
    47,895       76,096  
Property & equipment, net
    19,738       11,686  
Long-term investments
    43,917       47,758  
Other assets
    59,781       21,862  
 
           
Total assets
  $ 171,331     $ 157,402  
 
           
 
               
Liabilities & Stockholders’ Equity
               
 
               
Current liabilities
  $ 14,266     $ 6,753  
 
               
Deferred revenue (current and long-term)
    25,891       4,446  
 
               
Other liabilities
    252       1,000  
 
               
Total stockholders’ equity
    130,922       145,203  
 
               
 
           
Total liabilities & stockholders’ equity
  $ 171,331     $ 157,402  
 
           

 


 

SurModics Fourth Quarter and Fiscal Year 2007 Results
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SurModics, Inc. and Subsidiaries
Condensed Consolidated Statements of Cash Flows
(In thousands)
                 
    Year Ended  
    September 30,  
    2007     2006  
    (Unaudited)  
 
               
Operating Activities
               
Net Income
  $ 3,346     $ 20,334  
Depreciation and amortization
    4,214       3,710  
Purchased in-process R&D
    15,573       --  
Net other operating activities
    (692 )     6,433  
Net change in operating assets and liabilities
    28,273       4,802  
 
           
Net cash provided by operating activities
    50,714       35,279  
 
           
 
               
Investing Activities
               
Net purchases of property and equipment
    (3,588 )     (5,619 )
Business acquisitions, net of cash acquired
    (49,112 )     --  
Net other investing activities
    42,003       (33,340 )
 
           
Net cash provided (used) by investing activities
    (10,697 )     (38,959 )
 
           
 
               
Financing Activities
               
Issuance of common stock
    4,873       3,261  
Repurchase of common stock
    (35,030 )     --  
Net other financing activities
    201       249  
 
           
Net cash provided (used) by financing activities
    (29,956 )     3,510  
 
           
 
               
Net change in cash and cash equivalents
    10,061       (170 )
 
               
Cash and Cash Equivalents
               
Beginning of period
    3,751       3,921  
 
           
End of period
  $ 13,812     $ 3,751  
 
           
Certain information in this financial release may be considered non-GAAP Financial Information as contemplated by SEC Regulation G. Accordingly, we are providing the preceding tables, which reconcile results to their corresponding GAAP based operating results presented under our Statements of Operations.
Management believes the presentation of these non-GAAP financial results, in connection with the results of the fiscal quarter and year ended September 30, 2007, provide useful information to investors regarding our results of operations, as these non-GAAP financial measures, excluding charges related to acquisitions and investments, allow investors to better evaluate ongoing business performance and factors that influenced performance during the period under report, including when comparing against prior periods. Management also uses these non-GAAP measures internally to monitor performance of the business. These non-GAAP financial measures should be considered in addition to, and not a substitute for, financial measures prepared in accordance with GAAP.