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): May 7, 2009
Sucampo Pharmaceuticals, Inc. |
(Exact Name of Registrant as Specified in Charter) |
Delaware |
001-33609 |
30-0520478 |
(State or Other Jurisdiction 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):
⃞ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
⃞ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
⃞ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
⃞ 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 May 7, 2009, Sucampo Pharmaceuticals, Inc. announced its consolidated financial results for the quarter ended March 31, 2009. 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 May 7, 2009. |
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: | May 7, 2009 | By: |
/s/ JAN SMILEK |
|
Name: |
Jan Smilek |
|||
Title: |
Chief Financial Officer |
EXHIBIT INDEX
Exhibit No. |
Description |
99.1 | Press release issued by the registrant on May 7, 2009 |
Exhibit 99.1
Sucampo Pharmaceuticals Reports Results for the First Quarter of 2009
BETHESDA, Md.--(BUSINESS WIRE)--May 7, 2009--Sucampo Pharmaceuticals, Inc. (NASDAQ: SCMP) today reported its consolidated financial results for the quarter ended March 31, 2009.
Financial Highlights:
Operational Update:
“Each of the agreements we entered into this year represent a key element of Sucampo’s overall growth strategy. The Abbott agreement opens an additional market for one of our proprietary products and the RTU agreement adds an FDA-approved product to our portfolio. In addition, both agreements provide opportunities to develop new indications for Amitiza and Rescula, two prostone-based products,” said Ryuji Ueno, M.D., Ph.D., Ph.D., Co-Founder, Chairman and Chief Executive Officer.
Financial Results
Total revenues for the first quarter of 2009 were $15.5 million, an increase of $1.9 million or 14.5%, from $13.6 million for the first quarter of 2008. The key components of the changes in total revenues are:
Total operating expenses during the first quarter of 2009 were $18.0 million, a decrease of $1.3 million or 6.8%, from $19.3 million during the first quarter of 2008. The key components of the changes in operating expense are:
Total non-operating income during the first quarter of 2009 increased by $0.4 million, or 73.4%, to $1.1 million from $0.7 million for the first quarter of 2008. The increase was attributable primarily to foreign exchange gains offset by a reduction of interest income due to lower prevailing interest rates earned by Sucampo’s investments.
Income tax - Sucampo recorded an income tax provision of $0.4 million for the first quarter 2009 as compared to a tax benefit of $5.6 million for the first quarter of 2008. The tax benefit in the first quarter of 2008 was primarily due to a discrete release of U.S. deferred tax asset valuation allowances and a reduction in the estimated effective tax rate for 2008 based on the projected milestone and product royalty income. As of March 31, 2009, SPE and SPL have $5.0 million and $1.2 million, respectively, of net operating losses, for which the deferred tax assets are fully reserved.
The financial results of Sucampo’s wholly owned subsidiaries, which operate in different geographical regions of the world, continue to reflect the varying stages of development of the three subsidiaries:
Sucampo’s consolidated cash, cash equivalents and investments totaled $130.5 million at March 31, 2009 as compared with $121.5 million at December 31, 2008. The Company has no debt as of March 31, 2009.
Company to Host Conference Call Today
Sucampo management will host a conference call today, May 7, 2009 at 5:00 pm Eastern Time to discuss these results. To participate on the live call, please dial 800-383-7998 (domestic) or +1-617-597-5329 (international), and provide the participant passcode 32716473, five to ten minutes ahead of the start of the call. A replay of the call will be available within a few hours after the call ends. Investors may listen to the replay by dialing 888-286-8010 (domestic) or +1-617-801-6888 (international), with the passcode 32867202.
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
Sucampo Pharmaceuticals, Inc., a biopharmaceutical company based in Bethesda, Maryland, 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 currently Director and Advisor, International Business Development.
Sucampo markets Amitiza (lubiprostone) 24 mcg in the U.S. for Chronic Idiopathic Constipation in adults and Amitiza 8 mcg in the U.S. to treat Irritable Bowel Syndrome with Constipation in adult women. Sucampo also is developing the drug for additional gastrointestinal disorders with large potential markets. In April 2009, Sucampo acquired rights to Rescula, an FDA-approved treatment for open-angle glaucoma and ocular hypertension. Sucampo plans to re-launch the drug in 2010, and to develop it for additional ophthalmic indications. In addition, Sucampo has a robust pipeline of compounds with the potential to target underserved diseases, inclusive of age-related diseases, affecting millions of patients worldwide. Sucampo Pharmaceuticals, Inc. conducts its operations through three wholly owned subsidiaries: Sucampo Pharma Europe, Ltd., located in the UK; Sucampo Pharma, Ltd., based in Japan; and, Sucampo Pharma Americas, Inc., based in Maryland, US. To learn more about Sucampo and its products, visit www.sucampo.com.
Amitiza is registered trademark of Sucampo Pharmaceuticals, Inc. and Rescula is a registered trademark used under license.
Forward-Looking Statements
Any statements in this press release about future expectations, plans and prospects for Sucampo Pharmaceuticals, Inc. and its subsidiaries 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. Forward-looking statements include statements about potential trial results, the potential utility of Amitiza and Rescula to treat particular indications and expected data availability, trial commencement and regulatory dates. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including those described in Sucampo Pharmaceuticals’ filings with the Securities and Exchange Commission (SEC), including the annual report on Form 10-K for the year ended December 31, 2008 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.
(Financial Schedules Follow)
Sucampo Pharmaceuticals, Inc. | ||||||||||
Consolidated Statements of Operations (unaudited) | ||||||||||
(in thousands, except per share data) | ||||||||||
Three Months Ended March 31, | ||||||||||
2009 | 2008 | |||||||||
Revenues: | ||||||||||
Research and development revenue | $ | 5,526 | $ | 6,110 | ||||||
Product royalty revenue | 8,946 | 6,080 | ||||||||
Co-promotion revenue | 896 | 1,223 | ||||||||
Contract and collaboration revenue | 146 | 141 | ||||||||
Total revenues | 15,514 | 13,554 | ||||||||
Operating expenses: | ||||||||||
Research and development | 9,965 | 11,216 | ||||||||
General and administrative | 3,455 | 3,167 | ||||||||
Selling and marketing | 2,512 | 2,848 | ||||||||
Milestone royalties - related parties | 500 | 1,031 | ||||||||
Product royalties - related parties | 1,590 | 1,081 | ||||||||
Total operating expenses | 18,022 | 19,343 | ||||||||
Loss from operations | (2,508 | ) | (5,789 | ) | ||||||
Interest income | 312 | 642 | ||||||||
Other income, net | 822 | 12 | ||||||||
Total non-operating income, net | 1,134 | 654 | ||||||||
Loss before income taxes | (1,374 | ) | (5,135 | ) | ||||||
Income tax (provision) benefit | (401 | ) | 5,640 | |||||||
Net (loss) income | $ | (1,775 | ) | $ | 505 | |||||
Net (loss) income per share: | ||||||||||
Basic net (loss) income per share | $ | (0.04 | ) | $ | 0.01 | |||||
Diluted net (loss) income per share | $ | (0.04 | ) | $ | 0.01 | |||||
Weighted average common shares outstanding - basic | 41,844 | 41,733 | ||||||||
Weighted average common shares outstanding - diluted | 41,844 | 42,061 | ||||||||
Comprehensive (loss) income: | ||||||||||
Net (loss) income | $ | (1,775 | ) | $ | 505 | |||||
Other comprehensive loss: | ||||||||||
Unrealized loss on investments, net of tax effect | (65 | ) | (840 | ) | ||||||
Foreign currency translation | (203 | ) | 330 | |||||||
Comprehensive loss | $ | (2,043 | ) | $ | (5 | ) |
Sucampo Pharmaceuticals, Inc. | ||||||
Consolidated Balance Sheets (unaudited) | ||||||
(in thousands, except share data) | ||||||
March 31, | December 31, | |||||
2009 | 2008 | |||||
ASSETS: | ||||||
Current assets: | ||||||
Cash and cash equivalents | $ | 17,797 | $ | 11,536 | ||
Investments, current | 103,257 | 93,776 | ||||
Product royalties receivable | 8,945 | 9,725 | ||||
Unbilled accounts receivable | 3,826 | 4,373 | ||||
Accounts receivable | 249 | 878 | ||||
Prepaid and income taxes receivable | 1,539 | 133 | ||||
Deferred tax assets, net | 413 | 963 | ||||
Prepaid expenses and other current assets | 3,209 | 3,641 | ||||
Total current assets | 139,235 | 125,025 | ||||
Investments, non-current | 9,494 | 16,222 | ||||
Property and equipment, net | 2,272 | 2,275 | ||||
Deferred tax assets-noncurrent, net | 4,225 | 4,026 | ||||
Other assets | 873 | 3,246 | ||||
Total assets | $ | 156,099 | $ | 150,794 | ||
LIABILITIES AND STOCKHOLDERS' EQUITY: | ||||||
Current liabilities: | ||||||
Accounts payable | $ | 2,763 | $ | 1,433 | ||
Accrued expenses | 8,910 | 9,764 | ||||
Deferred revenue - current | 19,053 | 15,599 | ||||
Total current liabilities | 30,726 | 26,796 | ||||
Deferred revenue, net of current portion | 11,463 | 8,061 | ||||
Other liabilities | 2,047 | 2,147 | ||||
Total liabilities | 44,236 | 37,004 | ||||
Commitments | ||||||
Stockholders' equity: | ||||||
Preferred stock, $0.01 par value; 5,000,000 shares authorized |
- | - | ||||
Class A common stock, $0.01 par value; 270,000,000 shares
authorized |
156 | 156 | ||||
Class B common stock, $0.01 par value; 75,000,000 shares authorized |
262 | 262 | ||||
Additional paid-in capital | 98,359 | 98,243 | ||||
Accumulated other comprehensive income | 86 | 354 | ||||
Retained earnings | 13,000 | 14,775 | ||||
Total stockholders' equity | 111,863 | 113,790 | ||||
Total liabilities and stockholders' equity | $ | 156,099 | $ | 150,794 |
Sucampo Pharmaceuticals, Inc. | ||||||||||||||||||||||
Key Segment Information (unaudited) | ||||||||||||||||||||||
(in thousands, net of intercompany eliminations) | ||||||||||||||||||||||
United States | Europe | Japan | Consolidated | |||||||||||||||||||
Three Months Ended March 31, 2009 | ||||||||||||||||||||||
Product royalty revenue | $ | 8,946 | $ | - | $ | - | $ | 8,946 | ||||||||||||||
Research and development revenue | 5,152 | - | 374 | 5,526 | ||||||||||||||||||
Other revenue | 1,037 | - | 5 | 1,042 | ||||||||||||||||||
Total revenues | $ | 15,135 | $ | - | $ | 379 | $ | 15,514 | ||||||||||||||
Total operating expenses | 14,365 | 483 | 3,174 | 18,022 | ||||||||||||||||||
Other non-operating income (expenses), net | 552 | (13 | ) | 595 | 1,134 | |||||||||||||||||
Income (loss) before income tax | $ | 1,163 | $ | (519 | ) | $ | (2,018 | ) | $ | (1,374 | ) | |||||||||||
Three Months Ended March 31, 2008 | ||||||||||||||||||||||
Product royalty revenue | $ | 6,080 | $ | - | $ | - | $ | 6,080 | ||||||||||||||
Research and development revenue | 6,110 | - | - | 6,110 | ||||||||||||||||||
Other revenue | 1,364 | - | - | 1,364 | ||||||||||||||||||
Total revenues | $ | 13,554 | $ | - | $ | - | $ | 13,554 | ||||||||||||||
Total operating expenses | 16,834 | 1,838 | 671 | 19,343 | ||||||||||||||||||
Other non-operating income, net | 605 | 24 | 25 | 654 | ||||||||||||||||||
Loss before income tax | $ | (2,861 | ) | $ | (1,815 | ) | $ | (459 | ) | $ | (5,135 | ) |
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CONTACT:
Sucampo Pharmaceuticals, Inc.
Kate de Santis, 240-223-3834
kdesantis@sucampo.com
or
Westwicke
Partners, LLC
John Woolford, 443-213-0506
john.woolford@westwickepartners.com