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): August 3, 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 August 6, 2009, Sucampo Pharmaceuticals, Inc. announced its consolidated financial results for the quarter ended June 30, 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 5.02. Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.
On August 3, 2009, John Wright resigned as a member of the registrant’s Board of Directors.
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 August 6, 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: | August 6, 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 August 6, 2009 |
Exhibit 99.1
Sucampo Pharmaceuticals Reports Financial Results for the Second Quarter of 2009
BETHESDA, Md.--(BUSINESS WIRE)--August 6, 2009--Sucampo Pharmaceuticals, Inc. (NASDAQ:SCMP) today reported its consolidated financial results for the quarter and six months ended June 30, 2009.
Financial Highlights of the Quarter:
Operational Update:
“Despite the disappointing sales of Amitiza by Takeda in the U.S., the second quarter results of all our operating segments were substantially in line with our expectations,” said Ryuji Ueno, M.D., Ph.D., Ph.D., Co-Founder, Chairman and Chief Executive Officer. “We were able to reach another milestone with Abbott in Japan and we progressed in our R&D activities in the U.S. and Japan. Additionally, the acquisition of Rescula and cobiprostone’s positive results may open up new opportunities for Sucampo to address unmet medical needs and possible allegiances in the future.”
Financial Results for the Quarter and Year-to-Date
Total revenues for the second quarter of 2009 were $17.7 million, compared to $67.7 million for the second quarter of 2008, which included a $50.0 million milestone payment recognized as revenue upon the FDA approval of Amitiza (8 mcg) for the treatment of IBS-C in adult women. Total revenues for the first six months of 2009 were $33.2 million compared to $81.3 million for the first six months of 2008. The key elements of the changes in total revenues are:
Total operating expenses during the second quarter of 2009 were $16.7 million compared to $23.8 million during the second quarter of 2008. Total operating expenses during the six months ended June 30, 2009 were $34.7 million compared to $43.2 million during the prior year period. The key components of the changes in operating expense are:
Income tax - Sucampo recorded an income tax provision of $0.9 million for the second quarter of 2009 as compared to $14.6 million for the second quarter of 2008. Sucampo recorded an income tax provision of $1.3 million for the first six months of 2009 as compared to $8.9 million for the first six months of 2008. The income tax provision relates to the profitable results of Sucampo’s U.S. operations. The international subsidiaries continue to report net operating losses, for which the related deferred tax assets have a full valuation allowance.
The financial results for the second quarter of 2009 of Sucampo’s reportable segments, continue to reflect their respective varying stages of development:
Sucampo’s consolidated cash, cash equivalents and investments totaled $131.5 million at June 30, 2009 as compared with $121.5 million at December 31, 2008. Sucampo Pharmaceuticals Inc. had no debt as of June 30, 2009.
Company to Host Conference Call Today
Sucampo management will host a conference call today, August 6, 2009 at 5:00 pm Eastern Time to discuss these results. To participate on the live call, please dial 800-435-1261 (domestic) or +1-617-614-4076 (international), and provide the participant passcode 30938195, 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 617-801-6888 (international), with the passcode 80476642.
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., an international 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 is marketing 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 U.S. and Canadian 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, including 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.
Amitiza is co-marketed in the U.S. by Sucampo Pharmaceuticals, Inc. and Takeda Pharmaceuticals North America, Inc.
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 June 30, | Six Months Ended June 30, | |||||||||||||||
2009 | 2008 | 2009 | 2008 | |||||||||||||
Revenues: | ||||||||||||||||
Research and development revenue | $ | 7,395 | $ | 55,436 | $ | 12,921 | $ | 61,546 | ||||||||
Product royalty revenue | 8,914 | 10,901 | 17,860 | 16,981 | ||||||||||||
Co-promotion revenue | 1,244 | 1,236 | 2,140 | 2,458 | ||||||||||||
Contract and collaboration revenue | 152 | 141 | 298 | 283 | ||||||||||||
Total revenues | 17,705 | 67,714 | 33,219 | 81,268 | ||||||||||||
Operating expenses: | ||||||||||||||||
Research and development | 9,621 | 12,931 | 19,586 | 24,147 | ||||||||||||
General and administrative | 2,924 | 3,561 | 6,379 | 6,728 | ||||||||||||
Selling and marketing | 2,188 | 2,870 | 4,700 | 5,718 | ||||||||||||
Milestone royalties - related parties | 375 | 2,500 | 875 | 3,531 | ||||||||||||
Product royalties - related parties | 1,583 | 1,951 | 3,173 | 3,032 | ||||||||||||
Total operating expenses | 16,691 | 23,813 | 34,713 | 43,156 | ||||||||||||
Income (loss) from operations | 1,014 | 43,901 | (1,494 | ) | 38,112 | |||||||||||
Non-operating income (expense): | ||||||||||||||||
Interest income | 219 | 565 | 531 | 1,207 | ||||||||||||
Other income (expense), net | (608 | ) | (13 | ) | 214 | (1 | ) | |||||||||
Total non-operating income (expense), net | (389 | ) | 552 | 745 | 1,206 | |||||||||||
Income (loss) before income taxes | 625 | 44,453 | (749 | ) | 39,318 | |||||||||||
Income tax provision | (863 | ) | (14,577 | ) | (1,264 | ) | (8,937 | ) | ||||||||
Net income (loss) | $ | (238 | ) | $ | 29,876 | $ | (2,013 | ) | $ | 30,381 | ||||||
Net income (loss) per share: | ||||||||||||||||
Basic net income (loss) per share | $ | (0.01 | ) | $ | 0.72 | $ | (0.05 | ) | $ | 0.73 | ||||||
Diluted net income (loss) per share | $ | (0.01 | ) | $ | 0.71 | $ | (0.05 | ) | $ | 0.72 | ||||||
Weighted average common shares outstanding - basic | 41,844 | 41,757 | 41,844 | 41,745 | ||||||||||||
Weighted average common shares outstanding - diluted | 41,844 | 42,038 | 41,844 | 42,026 | ||||||||||||
Sucampo Pharmaceuticals, Inc. | ||||||
Consolidated Balance Sheets (unaudited) | ||||||
(in thousands, except share data) | ||||||
June 30, | December 31, | |||||
2009 | 2008 | |||||
ASSETS: | ||||||
Current assets: | ||||||
Cash and cash equivalents | $ | 41,737 | $ | 11,536 | ||
Investments, current | 68,435 | 93,776 | ||||
Product royalties receivable | 8,913 | 9,725 | ||||
Unbilled accounts receivable | 3,623 | 4,373 | ||||
Accounts receivable | 889 | 878 | ||||
Prepaid and income taxes receivable | 1,069 | 133 | ||||
Deferred tax assets, current | 291 | 963 | ||||
Prepaid expenses and other current assets | 2,965 | 3,641 | ||||
Total current assets | 127,922 | 125,025 | ||||
Investments, non-current | 21,330 | 16,222 | ||||
Property and equipment, net | 2,330 | 2,275 | ||||
Deferred tax assets, non-current | 4,002 | 4,026 | ||||
Other assets | 4,354 | 3,246 | ||||
Total assets | $ | 159,938 | $ | 150,794 | ||
LIABILITIES AND STOCKHOLDERS' EQUITY: | ||||||
Current liabilities: | ||||||
Accounts payable | $ | 2,029 | $ | 1,433 | ||
Accrued expenses | 10,770 | 9,764 | ||||
Deferred revenue - current |
21,305 |
15,599 | ||||
Total current liabilities |
34,104 |
26,796 | ||||
Deferred revenue, non-current |
11,771 |
8,061 | ||||
Other liabilities | 2,024 | 2,147 | ||||
Total liabilities | 47,899 | 37,004 | ||||
Commitments | ||||||
Stockholders' equity: | ||||||
Preferred stock, $0.01 par value; 5,000,000 shares authorized at June 30, 2009 and December 31, 2008; no shares issued and outstanding at June 30, 2009 and December 31, 2008 | - | - | ||||
Class A common stock, $0.01 par value; 270,000,000 shares authorized at June 30, 2009 and December 31, 2008; 15,653,375 and 15,651,849 shares issued and outstanding at June 30, 2009 and December 31, 2008, respectively | 156 | 156 | ||||
Class B common stock, $0.01 par value; 75,000,000 shares authorized at June 30, 2009 and December 31, 2008; 26,191,050 shares issued and outstanding at June 30, 2009 and December 31, 2008, respectively | 262 | 262 | ||||
Additional paid-in capital | 98,440 | 98,243 | ||||
Accumulated other comprehensive loss | 419 | 354 | ||||
Retained earnings | 12,762 | 14,775 | ||||
Total stockholders' equity | 112,039 | 113,790 | ||||
Total liabilities and stockholders' equity | $ | 159,938 | $ | 150,794 | ||
Sucampo Pharmaceuticals, Inc. | |||||||||||||||
Key Segment Information (unaudited) | |||||||||||||||
(in thousands, net of intercompany eliminations) | |||||||||||||||
Americas | Europe | Asia | Consolidated | ||||||||||||
Three Months Ended June 30, 2009 | |||||||||||||||
Product royalty revenue | $ | 8,914 | $ | - | $ | - | $ | 8,914 | |||||||
Research and development revenue | 3,825 | - | 3,570 | 7,395 | |||||||||||
Other revenue | 1,386 | - | 10 | 1,396 | |||||||||||
Total revenues | $ | 14,125 | $ | - | $ | 3,580 | $ | 17,705 | |||||||
Total operating expenses | 11,933 | 482 | 4,276 | 16,691 | |||||||||||
Other non-operating income (expenses), net | 256 | (334 | ) | (311 | ) | (389 | ) | ||||||||
Income (loss) before income tax | $ | 2,238 | $ | (816 | ) | $ | (797 | ) | $ | 625 | |||||
Six Months Ended June 30, 2009 | |||||||||||||||
Product royalty revenue | $ | 17,860 | $ | - | $ | - | $ | 17,860 | |||||||
Research and development revenue | 8,977 | - | 3,944 | 12,921 | |||||||||||
Other revenue | 2,423 | - | 15 | 2,438 | |||||||||||
Total revenues | $ | 29,260 | $ | - | $ | 3,959 | $ | 33,219 | |||||||
Total operating expenses | 26,298 | 965 | 7,450 | 34,713 | |||||||||||
Other non-operating income (expenses), net | 859 | (370 | ) | 256 | 745 | ||||||||||
Income (loss) before income tax | $ | 3,401 | $ | (1,335 | ) | $ | (2,815 | ) | $ | (749 | ) | ||||
Three Months Ended June 30, 2008 | |||||||||||||||
Product royalty revenue | $ | 10,901 | $ | - | $ | - | $ | 10,901 | |||||||
Research and development revenue | 55,436 | - | - | 55,436 | |||||||||||
Other revenue | 1,377 | - | - | 1,377 | |||||||||||
Total revenues | $ | 67,714 | $ | - | $ | - | $ | 67,714 | |||||||
Total operating expenses | 20,459 | 584 | 2,770 | 23,813 | |||||||||||
Other non-operating income (expenses), net | 584 | (31 | ) | (1 | ) | 552 | |||||||||
Income (loss) before income tax | $ | 47,629 | $ | (615 | ) | $ | (2,561 | ) | $ | 44,453 | |||||
Six Months Ended June 30, 2008 | |||||||||||||||
Product royalty revenue | $ | 16,981 | $ | - | $ | - | $ | 16,981 | |||||||
Research and development revenue | 61,546 | - | - | 61,546 | |||||||||||
Other revenue | 2,741 | - | - | 2,741 | |||||||||||
Total revenues | $ | 81,268 | $ | - | $ | - | $ | 81,268 | |||||||
Total operating expenses | 37,293 | 2,422 | 3,441 | 43,156 | |||||||||||
Other non-operating income (expenses), net | 1,210 | (8 | ) | 4 | 1,206 | ||||||||||
Income (loss) before income tax | $ | 44,768 | $ | (2,430 | ) | $ | (3,020 | ) | $ | 39,318 | |||||
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