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UNITED STATES
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): March 11, 2008
Sucampo Pharmaceuticals, Inc.
(Exact Name of Registrant as Specified in Charter)
         
Delaware   001-33609   13-3929237
 
(State or Other Juris-
diction of Incorporation)
  (Commission
File Number)
  (IRS Employer
Identification No.)
     
4520 East-West Highway, Suite 300    
Bethesda, Maryland   20814
 
(Address of Principal Executive Offices)   (Zip Code)
Registrant’s telephone number, including area code: (301) 961-3400
 
(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 (see General Instruction A.2. below):
     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 March 11, 2008, Sucampo Pharmaceuticals, Inc. announced its consolidated financial results for the fourth quarter and year ended December 31, 2007. The full text of the press release issued in connection with the announcement is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
     The information in this Form 8-K (including Exhibit 99.1) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as expressly set forth by specific reference in such a filing.
Item 9.01   Financial Statements and Exhibits
     (d) Exhibits
          The following exhibit relating to Item 2.02 shall be deemed to be furnished, and not filed:
          99.1      Press Release issued by the registrant on March 11, 2008.

 


 

SIGNATURE
     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.
         
  SUCAMPO PHARMACEUTICALS, INC.
 
 
Date: March 11, 2008  By:   /s/ MARIAM E. MORRIS    
    Name:   Mariam E. Morris   
    Title:   Chief Financial Officer   
 

 


 

EXHIBIT INDEX
         
Exhibit No.   Description
       
 
  99.1    
Press release issued by the registrant on March 11, 2008

 

exv99w1
 

Exhibit 99.1
(SUCAMPO PHARMACEUTICALS, INC. LOGO)
         
Mariam Morris
  or   P. Curtis Schenck
Chief Financial Officer
      Director, Investor Relations
Sucampo Pharmaceuticals, Inc.
      Sucampo Pharmaceuticals, Inc.
301-961-3400
      301-961-3400
mmorris@sucampo.com
      cschenck@sucampo.com
Sucampo Pharmaceuticals Reports Financial Results
for the Fourth Quarter and Full Year of 2007
AMITIZA® Sales and R&D Success Fuel Growth
Bethesda, Md., March 11, 2008 — Sucampo Pharmaceuticals, Inc. (NASDAQ: SCMP) today reported its consolidated financial results for the fourth quarter and year ended December 31, 2007. The Company achieved its second consecutive year of profitability and continued to strengthen its financial position.
Fourth-Quarter 2007 Highlights
    Product royalty revenue increased by $6.6 million, or more than 300%, year-over-year on growth of U.S. sales of AMITIZA® (lubiprostone, 24 mcg), for Chronic Idiopathic Constipation in adults.
 
    Sucampo and co-marketing partner Takeda Pharmaceutical Company, Ltd. (Takeda) initiated a national television Direct-To-Consumer (DTC) marketing campaign for AMITIZA®.
Full-Year 2007 Highlights
    Sucampo reported net income of $13.2 million, or $0.35 per diluted share, for the year ended December 31, 2007. Sucampo strengthened its liquidity and capital resources with cash and cash equivalents of $25.6 million and investments of $61.0 million and total shareholders’ equity of $86.5 million at December 31, 2007.
 
    Sucampo earned a $30.0 million milestone payment from Takeda upon submission of a supplemental New Drug Application (sNDA) seeking approval of AMITIZA for Irritable Bowel Syndrome with Constipation (IBS-C).
 
    Sucampo completed an initial build-out of internal specialty sales force targeting long-term care facilities as well as medical schools and university hospitals.
 
    Sucampo completed an initial public offering that raised $28.2 million in net proceeds.
 
    Sucampo initiated full Phase III studies of AMITIZA for Opioid-Induced Bowel Dysfunction (OBD).

 


 

    Sucampo began a Phase II study of a second compound, cobiprostone, for the prevention of Non-Steroidal Anti-Inflammatory Drug (NSAID)-induced ulcers.
“In recent months, Sucampo has achieved a number of operational and financial objectives that demonstrate the success of AMITIZA® in the U.S. and the potential for lubiprostone abroad as we focus on expanding into new indications and entering new markets,” said Ryuji Ueno, M.D., Ph.D., Ph.D., founder, chairman and chief executive officer. “The launch of the television DTC campaign for AMITIZA®, combined with the efforts of our internal specialty sales force, has helped to drive sales growth and build brand recognition among patients and physicians. We are optimistic that we will be able to capitalize on the positive awareness of AMITIZA®.”
Financial Results
Total revenues for the quarter ended December 31, 2007 increased 51% to $17.1 million from $11.4 million for the fourth quarter ended December 31, 2006 and increased 55% to $91.9 million for the year ended December 31, 2007 from $59.3 million for the year ended December 31, 2006.
The key components of total revenues are as follows:
    Product royalty revenue increased to $8.7 million for the fourth quarter of 2007 compared with $2.0 million for the fourth quarter of 2006; and product royalty revenue increased to $27.5 million for the year ended December 31, 2007 from $6.6 million in 2006. The increase reflects the significant growth in the U.S. sales of AMITIZA® for the treatment of Chronic Idiopathic Constipation in adults since its commercial launch in April 2006.
 
    Research and development (R&D) revenue declined slightly to $7.3 million for the fourth quarter of 2007 from $7.5 million for the fourth quarter of 2006. R&D revenue increased to $59.4 million for the year ended December 31, 2007 from $46.4 million in 2006, due primarily to the $30.0 million milestone payment earned from Takeda in June 2007 upon the filing of the sNDA for AMITIZA for the treatment of IBS-C, offset in part by a decline of $17.0 million of R&D reimbursement payments from Takeda reflecting the recognition of AMITIZA related deferred revenue for six months in 2007, when the related performance period was completed, compared with twelve months in 2006.
In the fourth quarter of 2007, Sucampo reported a net loss of $0.7 million, or $0.02 per diluted share, based on 41.7 million weighted average diluted common shares outstanding, compared with net income of $4.9 million, or $0.14 per diluted share, for the fourth quarter of 2006, based on 35.3 million weighted average diluted common shares outstanding. In the fourth quarter of 2007, Sucampo recorded $0.1 million in net tax benefits versus $4.9 million in net tax benefits for the fourth quarter of 2006 resulting from the recognition of deferred tax assets. Sucampo

 


 

reported a loss before income taxes of $0.9 million in the fourth quarter of 2007 compared with income before income taxes of $40,000 in the fourth quarter of 2006. The loss for the fourth quarter of 2007 resulted primarily from increases in R&D expenses to expand our current pipeline initiatives and an increase in overall costs associated with being a publicly-traded company, including insurance costs and fees for legal, accounting, Sarbanes-Oxley Act compliance and other professional services.
For the year ended December 31, 2007, Sucampo reported net income of $13.2 million, or $0.35 per diluted share, based on 38.2 million weighted average diluted common shares outstanding compared with net income of $21.8 million, or $0.63 per diluted share for 2006, based on 34.7 million weighted average diluted common shares outstanding. For 2007, Sucampo recorded a tax provision of $7.8 million compared with an income tax benefit of $4.9 million in 2006. Sucampo reported income before income taxes of $21.0 million for 2007 compared with income before income taxes of $16.9 million in 2006. The increase in income before taxes for 2007 resulted primarily from the significant growth of our product royalty revenue associated with the U.S. sales of AMITIZA®.
Total operating expenses incurred during the fourth quarter of 2007 increased to $19.3 million from $11.9 million for the fourth quarter of 2006 and increased to $73.5 million for the year ended December 31, 2007 compared with $44.5 million in 2006.
The key components of the operating expense increases are as follows:
    The increase in R&D expenses of $11.9 million to $28.3 million during the year ended December 31, 2007 from $16.4 million in 2006 was associated with Sucampo’s clinical development programs for IBS-C, the initiation of its OBD clinical studies of AMITIZA and the initiation of its NSAID clinical study of cobiprostone, as well as its ongoing development of other prostone compounds.
 
    The increase in general and administrative (G&A) expenses of $10.4 million to $25.0 million during the year ended December 31, 2007 from $14.6 million in 2006 was primarily the result of a one-time cash and stock-based awards to Sucampo’s founders of $9.2 million for stock options previously granted and now terminated. G&A expenses also reflected higher operational headcount and higher rent expense for new leased office space, and additional costs associated with being a publicly-traded company.
 
    The increase in selling and marketing expenses of $2.1 million to $13.2 million during the year ended December 31, 2007 from $11.1 million in 2006 reflected one full year of commercial activity in 2007 for AMITIZA®, which was launched in the second quarter of 2006.

 


 

Dr. Ueno continued, “We are proceeding from a position of financial and operational strength. Sucampo’s cash and cash equivalents and investments totaled $86.5 million at the end of 2007 as compared with $51.9 million at the end of 2006. This position could enable Sucampo to in-license and market select drugs. I should also point out that on-going sales of AMITIZA® are helping to fund the advancement of our pipeline of future drug candidates. Also, if Sucampo succeeds in advancing AMITIZA® for approval for additional therapeutic indications, those developments could trigger milestone payments as well as an increase in product royalties.”
Under the Prescription Drug User Fee Act of 1992, Sucampo expects the U.S. Food and Drug Administration’s decision regarding its sNDA for AMITIZA for the treatment of IBS-C on or about April 29, 2008. If the drug is approved for this indication, Sucampo would receive a $50.0 million milestone payment from Takeda.
“Sucampo enjoyed an outstanding year in 2007 and we look forward to accomplishing a number of significant milestones in the year ahead,” said Dr. Ueno.
Company to Host Conference Call
In conjunction with its fourth quarter and full year financial results, Sucampo will host a conference call at 10:00 a.m. ET Tuesday, March 11, 2008. To participate on the live call, please dial (866) 700-6293 (domestic) or (617) 213-8835 (international) and providing the participant passcode 65493260. A replay of the call will be available until midnight Tuesday, March 25, 2008 by dialing (888) 286-8010 (U.S. and Canada) or (617) 801-6888 (international). Confirmation code for the replay is 52571342. A live and archived audio webcast of the call will be available via the “For Investors” page of the Sucampo Pharmaceuticals website, www.sucampo.com. Please dial in or log on through Sucampo Pharmaceuticals’ website approximately 10 minutes prior to the scheduled start time.
About Sucampo Pharmaceuticals, Inc.
Sucampo Pharmaceuticals, Inc., a specialty biopharmaceutical company based in Bethesda, MD, focuses on the development and commercialization of medicines based on prostones. The therapeutic potential of prostones, which are bio-lipids that occur naturally in the human body, was first identified by Ryuji Ueno, M.D., Ph.D., Ph.D., Sucampo Pharmaceuticals’ chairman and chief executive officer. Dr. Ueno founded Sucampo Pharmaceuticals in 1996 with Sachiko Kuno, Ph.D., founding chief executive officer and advisor, international business development.
Sucampo Pharmaceuticals is marketing AMITIZA® (lubiprostone) in the U.S. for chronic idiopathic constipation in adults and is developing the drug for additional gastrointestinal disorders with large potential markets. In addition, Sucampo Pharmaceuticals has a robust pipeline of compounds with the potential to target underserved diseases affecting millions of patients worldwide. Sucampo Pharmaceuticals has two wholly-owned subsidiaries: Sucampo Pharma Europe, Ltd. headquartered in Oxford, UK with a branch office in Basel, Switzerland, and Sucampo Pharma, Ltd. located in Tokyo and Osaka, Japan. To learn more about Sucampo Pharmaceuticals and its products, visit www.sucampo.com.

 


 

Forward-Looking Statements
Any statements in this press release about future expectations, plans and prospects for Sucampo Pharmaceuticals are forward-looking statements made under the provisions of The Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the words “project,” “believe,” “anticipate,” “plan,” “expect,” “estimate,” “intend,” “should,” “would,” “could,” “will,” “may” or other similar expressions. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors described in Sucampo Pharmaceuticals’ filings with the Securities and Exchange Commission (SEC), including the quarterly report on Form 10-Q for the period ended September 30, 2007 and other periodic reports filed with the SEC. Any forward-looking statements in this press release represent Sucampo Pharmaceuticals’ views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. Sucampo Pharmaceuticals anticipates that subsequent events and developments will cause its views to change. However, while Sucampo Pharmaceuticals may elect to update these forward-looking statements publicly at some point in the future, Sucampo Pharmaceuticals specifically disclaims any obligation to do so, whether as a result of new information, future events or otherwise.

 


 

SUCAMPO PHARMACEUTICALS, INC.
Consolidated Statements of Operations (unaudited)

(In thousands, except per share data)
                                 
    Three Months Ended     Year Ended  
    December 31,     December 31,  
    2007     2006     2007     2006  
Revenues:
                               
Research and development revenue
  $ 7,274     $ 7,482     $ 59,379     $ 46,382  
Product royalty revenue
    8,667       2,027       27,536       6,590  
Co-promotion revenue
    1,093       1,685       4,411       4,243  
Contract revenue – related parties
    74       141       418       404  
Collaboration revenue
    37       37       147       147  
Contract revenue
                      1,500  
 
                       
Total revenues
    17,145       11,372       91,891       59,266  
 
                       
Operating expenses:
                               
Research and development
    8,280       4,037       28,334       16,392  
General and administrative
    5,367       3,608       25,031       14,587  
Selling and marketing
    3,577       4,030       13,229       11,103  
Product royalties – related parties
    1,536       191       4,890       1,171  
Milestone royalties – related parties
    500             2,000       1,250  
 
                       
Total operating expenses
    19,260       11,866       73,484       44,503  
 
                       
(Loss) income from operations
    (2,115 )     (494 )     18,407       14,763  
Non-operating income (expense):
                               
Interest income
    890       573       2,465       1,976  
Interest expense
          (6 )           (90 )
Other income, net
    343       (33 )     151       255  
 
                       
Total non-operating income, net
    1,233       534       2,616       2,141  
 
                       
(Loss) income before income taxes
    (882 )     40       21,023       16,904  
Income tax benefit (provision)
    147       4,897       (7,833 )     4,897  
 
                       
Net (loss) income
  $ (735 )   $ 4,937     $ 13,190     $ 21,801  
 
                       
Net (loss) income per share:
                               
Basic net (loss) income per share
  $ (0.02 )   $ 0.14     $ 0.35     $ 0.63  
 
                       
Diluted net (loss) income per share
  $ (0.02 )   $ 0.14     $ 0.35     $ 0.63  
 
                       
Weighted average common shares outstanding – basic
    41,730       34,990       37,778       34,383  
 
                       
Weighted average common shares outstanding – diluted
    41,730       35,298       38,226       34,690  
 
                       

 


 

SUCAMPO PHARMACEUTICALS, INC.
Consolidated Balance Sheets (unaudited)

(In thousands, except share data)
                 
    December 31,  
    2007     2006  
ASSETS:
               
Current assets:
               
Cash and cash equivalents
  $ 25,559     $ 22,481  
Investments, short-term
    51,552       29,399  
Accounts receivable
    1,525       1,537  
Unbilled accounts receivable
    5,883        
Product royalties receivable
    8,667       2,029  
Prepaid and income taxes receivable
    1,922       2,355  
Deferred tax assets, net
    88       1,612  
Prepaid expenses and other current assets
    2,222       536  
 
           
Total current assets
    97,418       59,949  
Restricted cash
    213       213  
Investments, long-term
    9,400        
Property and equipment, net
    2,265       343  
Deferred tax assets – noncurrent, net
    551       3,289  
Deposits and other assets
    180       3,290  
 
           
Total assets
  $ 110,027     $ 67,084  
 
           
 
               
LIABILITIES AND STOCKHOLDERS’ EQUITY:
               
Current liabilities:
               
Accounts payable
  $ 3,313     $ 2,391  
Accrued expenses
    8,730       5,418  
Deferred revenue – current
    1,062       11,517  
 
           
Total current liabilities
    13,105       19,326  
Deferred revenue, net of current portion
    8,626       9,192  
Other liabilities
    1,768       33  
 
           
Total liabilities
    23,499       28,551  
 
           
 
               
Commitments
               
 
               
Stockholders’ equity:
               
Series A convertible preferred stock, $0.01 par value; 0 and 10,000 shares authorized at December 31, 2007 and 2006, respectively; 0 and 3,780 shares issued and outstanding at December 31, 2007 and 2006, respectively
          20,288  
Preferred stock, $0.01 par value; 5,000,000 and 0 shares authorized at December 31, 2007 and 2006, respectively; no shares issued and outstanding at December 31, 2007 and 2006
           
Class A common stock, $0.01 par value; 270,000,000 and 75,000,000 shares authorized at December 31, 2007 and 2006, respectively; 15,538,518 and 8,799,385 shares issued and outstanding at December 31, 2007 and 2006, respectively
    155       88  
Class B common stock, $0.01 par value; 75,000,000 shares authorized; 26,191,050 shares issued and outstanding at December 31, 2007 and 2006
    262       262  
Additional paid-in capital
    96,680       41,555  
Accumulated other comprehensive loss
    (393 )     (294 )
Accumulated deficit
    (10,176 )     (23,366 )
 
           
Total stockholders’ equity
    86,528       38,533  
 
           
Total liabilities and stockholders’ equity
  $ 110,027     $ 67,084