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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
Date of Report (Date of earliest event reported): January 25, 2006
SurModics, Inc.
(Exact name of Registrant as Specified in its Charter)
Minnesota
(State or Other Jurisdiction of Incorporation)
     
0-23837
(Commission File Number)
  41-1356149
(IRS Employer
Identification No.)
9924 West 74th Street
Eden Prairie, Minnesota 55344
(Address of Principal Executive Offices and Zip Code)
(952) 829-2700
(Registrant’s telephone number, including area code)
Not Applicable
(Former Name or Former Address, if Changed Since Last Report)
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:
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 January 25, 2006, SurModics, Inc. issued a press release announcing the results for its fiscal quarter ended December 31, 2005. The 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)   Exhibits: 99.1 Press Release dated January 25, 2006.
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.
 
           
 
      By   /s/ Philip D. Ankeny
 
           
Date:  January 25, 2006
      Name:
Title:
  Philip D. Ankeny
Chief Financial Officer

 


 

SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
EXHIBIT INDEX
to
FORM 8-K
SURMODICS, INC.
     
Date of Report:
January 25, 2006
  Commission File No.:
          0-23837
     
Exhibit No.   ITEM
99.1
  Press Release dated January 25, 2006.

 

exv99w1
 

Exhibit 99.1
SurModics Reports First Quarter 2006 Results
Sixth Consecutive Quarter of Record Non-GAAP Net Income
EDEN PRAIRIE, Minnesota — January 25, 2006 — SurModics, Inc. (Nasdaq: SRDX), a leading provider of surface modification and drug delivery technologies to the healthcare industry, today reported financial results for the first quarter ended December 31, 2005.
First Quarter Highlights:
  Revenue of $16.5 million, up 17% year-over-year
 
  R&D revenue of $1.8 million, up 62% sequentially
 
  GAAP results:
    Operating income of $8.6 million
 
    Net income of $6.2 million
 
    Diluted EPS of $0.33
  Non-GAAP results:
    Record operating income of $9.7 million
 
    Record net income of $6.6 million
 
    Record diluted EPS of $0.35
  Four new licenses signed, including one with Conor Medsystems for the hydrophilic coating on their next generation drug eluting stent delivery system
 
  Record CYPHER sales of $670 million
 
  6th consecutive quarter of record non-GAAP net income
 
  7th consecutive quarter with non-Cordis revenue exceeding Cordis revenue
“SurModics is pleased to report strong revenue and record adjusted earnings for the first quarter of fiscal year 2006,” said Bruce Barclay, President and CEO. “This marks the sixth consecutive quarter of record non-GAAP net income for SurModics. Several significant events occurred during the quarter. We are particularly encouraged by the strong sequential growth in research and development revenue, which is the highest in four quarters. We believe the sequential growth in R&D revenue speaks to the relevance our technologies have for our customers. A significant amount of the growth in R&D revenue resulted from customer supported projects incorporating our site specific drug delivery technologies for cardiovascular and ophthalmology applications. Our R&D organization continues to make terrific progress on many high potential projects with our growing customer base.”

 


 

“One year after closing the InnoRx acquisition, we are delighted with the strong customer interest in our drug delivery platforms, portfolio of polymer technologies and collaborative development capabilities, as more companies evaluate their drugs for treating serious diseases of the eye,” continued Barclay. “We are pleased to report that SurModics currently has multiple paid feasibility and development programs in ophthalmology underway, evaluating both our drug delivery platforms and polymer matrix technologies. At least one of these programs is being sponsored by a major pharmaceutical company. In addition, early feedback from the clinical trial of our I-vation™ Intravitreal Implant has been very positive, and we expect to complete enrollment in the near term.”
“Further, our customers continue to generate meaningful results which we believe will benefit SurModics both now and in the future,” commented Barclay. “The CYPHER Sirolimus-eluting Coronary Stent from Cordis Corporation, a Johnson & Johnson company, generated record sales in the quarter; FoxHollow issued strong 2006 revenue guidance; and we are pleased to report that Novocell commenced their Phase I/II human clinical trial in December.”
Revenue for the first quarter of fiscal 2006 was $16.5 million, an increase of 17% from $14.1 million in the year earlier period. R&D revenue of $1.8 million represents a sequential increase of 62% from $1.1 million in the September quarter and a slight decline from the first quarter of 2005 when InnoRx, which we acquired in January 2005, was an important R&D customer. On a GAAP basis, operating income was $8.6 million; net income was $6.2 million; and diluted earnings per share was $0.33. This quarter marks the first period in which SurModics’ results include expensing of stock options, as required by SFAS No. 123(R). GAAP results also include a $465,000, or $0.02 per diluted share, benefit related to the reversal of a tax reserve.
On a non-GAAP basis, operating income grew 12% to a record $9.7 million, from $8.7 million in the prior-year period. Net income increased 24% to a record $6.6 million, from $5.3 million in the same period last year. Diluted earnings per share was a record $0.35, compared with $0.30 in the first quarter of fiscal 2005. Non-GAAP results exclude non-cash compensation charges and the tax benefit further

 


 

detailed in Note (4) of the Statements of Income for the quarter ended December 31, 2005. Operating expenses, after excluding non-cash compensation charges, were the lowest in three quarters. Construction of new coating suites and manufacturing space at our Eden Prairie, Minnesota headquarters is ahead of schedule and under budget. We now project the roughly $1 million savings in annual operating expenses from exiting our Bloomington, Minnesota facility to commence in the third quarter of fiscal 2006.
SurModics’ pipeline continues to represent significant potential. The company signed four new licenses in the first quarter, making good progress toward its goal of 15 for fiscal year 2006. One of these licenses is with Conor Medsystems for use of SurModics’ hydrophilic coating technology on their next generation DES delivery system. As of December 31, 2005, SurModics’ customers had 80 licensed product categories generating royalty revenue, unchanged from the prior-year period; the total number of licensed product classes not yet launched was 74, compared with 63 in the prior-year period; and major non-licensed opportunities totaled 67, compared with 68 a year ago. In total, SurModics now has 141 potential commercial products in development representing each of the company’s four focus markets — Cardiovascular, Neurology, Ophthalmology and Orthopedics.
“SurModics remains in excellent financial condition,” said Phil Ankeny, Chief Financial Officer and Vice President, Business Development. “We are managing our expenses responsibly, without compromising our investment in R&D. Our balance sheet remains strong, with a cash and investment balance of $80.5 million and no debt as of December 31, 2005. We continue to have an active business development pipeline, as we evaluate potentially compelling opportunities to put our balance sheet to work.”
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 web site, www.surmodics.com, and click on the first quarter webcast icon. A replay of the first quarter conference call will be available by dialing 800-405-2236 and entering conference call ID 11050823. The audio replay will be available beginning at 6:00 p.m. CT on Wednesday, January 25, until 6:00 p.m. CT on Wednesday, February 1.

 


 

About SurModics, Inc.
SurModics, Inc. is a leading provider of surface modification technologies in the areas of biocompatibility, site-specific drug delivery, biological cell encapsulation, and medical diagnostics. SurModics partners with the world’s foremost medical device, pharmaceutical and life science companies to bring innovation together for better patient outcomes. Recent collaborative efforts include the implementation of SurModics’ Bravo™ drug delivery polymer matrix as a key component of the first-to-market drug-eluting coronary stent and the use of the CELLabration™ encapsulation system as an immunoprotective coating for implantable human islet cells. SurModics is also active in the ophthalmology market with a sustained drug delivery system that is currently in human trials for treatment of retinal disease. A significant portion of SurModics’ revenue is generated by royalties earned from the sale of our customers’ commercial products. SurModics is headquartered in Eden Prairie, MN. More information about the company can be found at 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
Certain statements contained in this press release may be deemed to be forward-looking statements under federal securities laws, and SurModics intends that such forward looking statements be subject to the safe harbor created thereby. SurModics does not undertake an obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
Contact
Phil Ankeny, Chief Financial Officer and Vice President, Business Development
(952) 829-2700

 


 

SurModics, Inc.
Statements of Income
Reconciliation of GAAP to Non-GAAP Amounts
(In thousands, except per share data)
(Unaudited)
                         
    Three Months Ended  
    December 31, 2005  
                    Non-  
    GAAP(1)     Adjustments     GAAP(2)  
     
Revenue:
                       
Royalties and license fees
  $ 12,275             $ 12,275  
Product sales
    2,347               2,347  
Research & development
    1,843               1,843  
 
                   
Total revenue
    16,465               16,465  
 
                       
Operating expenses:
                       
Product
    681       (23) (3)     658  
Research & development
    4,593       (452) (3)     4,141  
Sales & marketing
    324       (38) (3)     286  
General & administrative
    2,287       (649) (3)     1,638  
 
                   
Total operating expenses
    7,885       (1,162 )     6,723  
 
                   
Income from operations
    8,580       1,162       9,742  
 
                       
Investment income
    728               728  
 
                   
Income before income taxes
    9,308       1,162       10,470  
 
                       
Income tax provision
    (3,090 )     (808) (4)     (3,898 )
 
                   
Net income
  $ 6,218       354     $ 6,572  
 
                   
 
                       
Basic net income per share
  $ 0.34             $ 0.36  
 
                   
 
                       
Diluted net income per share
  $ 0.33             $ 0.35  
 
                   
 
                       
Weighted average shares outstanding
                       
Basic
    18,436               18,436  
Diluted
    18,643               18,935  

(1)   Reflects operating results in accordance with U.S. generally accepted accounting principles (or GAAP).
 
(2)   Non-GAAP figures exclude non-cash compensation charges and the tax items detailed in Note (4).
 
(3)   Reflects non-cash compensation charges.
 
(4)   Non-GAAP effective tax rate is 37.2% vs. an assumed GAAP continuing operations effective tax rate of 38.4%. In addition, non-GAAP results exclude a $465,000 benefit related to the reversal of a tax accrual resulting from settlement during the quarter of a state’s prior year tax returns.
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SurModics, Inc.
Statements of Income
Reconciliation of GAAP to Non-GAAP Amounts
(In thousands, except per share data)
(Unaudited)
                         
    Three Months Ended  
    December 31, 2004  
                    Non-  
    GAAP(1)     Adjustments     GAAP(2)  
     
Revenue:
                       
Royalties and license fees
  $ 10,091             $ 10,091  
Product sales
    2,000               2,000  
Research & development
    1,978               1,978  
 
                   
Total revenue
    14,069               14,069  
 
                       
Operating expenses:
                       
Product
    620               620  
Research & development
    3,355               3,355  
Sales & marketing
    262               262  
General & administrative
    1,194       (94) (3)     1,100  
 
                   
Total operating expenses
    5,431       (94 )     5,337  
 
                   
Income from operations
    8,638       94       8,732  
 
                       
Investment income
    (28 )             (28 )
 
                   
Income before income taxes
    8,610               8,704  
 
                       
Income tax provision
    (3,373 )     (36 )     (3,409 )
 
                   
Net income
  $ 5,237       58     $ 5,295  
 
                   
 
                       
Basic net income per share
  $ 0.30             $ 0.30  
 
                   
 
                       
Diluted net income per share
  $ 0.29             $ 0.30  
 
                   
 
                       
Weighted average shares outstanding
                       
Basic
    17,574               17,574  
Diluted
    17,950               17,950  

(1)   Reflects operating results in accordance with U.S. generally accepted accounting principles (or GAAP).
 
(2)   Non-GAAP figures exclude non-cash compensation charges.
 
(3)   Reflects non-cash compensation charges.
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SurModics, Inc.
Condensed Balance Sheets
(In thousands)
                 
    December 31,     September 30,  
    2005     2005  
Assets   (Unaudited)          
Current assets:
               
Cash & investments
  $ 33,638     $ 24,445  
Accounts receivable
    11,307       10,996  
Inventories
    1,153       1,091  
Other current assets
    1,535       5,072  
 
           
Total current assets
    47,633       41,604  
 
               
Property & equipment, net
    16,658       14,832  
Long-term investments
    46,898       48,874  
Other assets
    19,434       18,915  
 
               
 
           
Total assets
  $ 130,623     $ 124,225  
 
           
Liabilities & Stockholders’ Equity
               
 
               
Total current liabilities
  $ 3,785     $ 5,123  
 
               
Other liabilities
    3,428       3,521  
 
               
Total stockholders’ equity
    123,410       115,581  
 
               
 
           
Total liabilities & stockholders’ equity
  $ 130,623     $ 124,225  
 
           
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