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): November 5, 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 November 5, 2009, Sucampo Pharmaceuticals, Inc. announced its consolidated financial results for the quarter ended September 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 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 November 5, 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: | November 5, 2009 | By: |
/s/ JAN SMILEK |
|
Name: |
Jan Smilek |
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Title: |
Chief Financial Officer |
EXHIBIT INDEX
Exhibit No. |
Description |
99.1 | Press release issued by the registrant on November 5, 2009 |
Exhibit 99.1
Sucampo Pharmaceuticals Reports Financial Results for the Third Quarter of 2009
BETHESDA, Md.--(BUSINESS WIRE)--November 5, 2009--Sucampo Pharmaceuticals, Inc. (NASDAQ:SCMP) today reported its consolidated financial results for the quarter and nine months ended September 30, 2009.
Financial Highlights of the Quarter:
Operational Update:
“We continue our review of Takeda’s performance regarding the disappointing sales of Amitiza and possible methods to revitalize growth for the product,” said Ryuji Ueno, M.D., Ph.D., Ph.D., Co-Founder, Chairman and Chief Executive Officer. “In the meantime, we continue to push forward in clinical development of Amitiza in other geographies and for other indications, we are preparing for the re-launch of Rescula for glaucoma as well as pursuing Rescula for additional indications with significant market and value potential, and we are proceeding in the development of our other pipeline product candidates.”
Financial Results for the Quarter and Year-to-Date
Total revenues for the third quarter of 2009 were $17.8 million, compared to $14.5 million for the third quarter of 2008. Total revenues for the first nine months of 2009 were $51.1 million compared to $95.7 million for the first nine months of 2008. The key elements of the changes in total revenues are:
Total operating expenses during the third quarter of 2009 were $16.4 million compared to $19.3 million during the third quarter of 2008. Total operating expenses during the nine months ended September 30, 2009 were $51.1 million compared to $62.4 million during the prior year period. The key components of the changes in operating expenses are:
Income tax - Sucampo recorded an income tax provision of $1.5 million for the third quarter of 2009 as compared to an income tax benefit of $1.7 million for the third quarter of 2008. Sucampo recorded an income tax provision of $2.7 million for the first nine months of 2009 as compared to $7.2 million for the first nine months of 2008. The income tax benefit/provision relates mainly to the profitable results of Sucampo’s U.S. operations.
The financial results for the third quarter of 2009 of Sucampo’s reportable segments (United States, Europe and Japan), continue to reflect their respective varying stages of development:
Sucampo’s consolidated cash, cash equivalents and investments totaled $123.6 million at September 30, 2009 as compared with $121.5 million at December 31, 2008. Sucampo Pharmaceuticals, Inc. had no debt as of September 30, 2009.
Company to Host Conference Call Today
Sucampo management will host a conference call today, November 5, 2009 at 4:30 pm Eastern Time to discuss these results. To participate on the live call, please dial 866-783-2138 (domestic) or +1-857-350-1597 (international), and provide the participant passcode 31403000, 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 52346247.
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 addition, Sucampo has a robust pipeline of compounds with the potential to target underserved diseases affecting millions of patients worldwide. Sucampo Pharmaceuticals, Inc. has three wholly owned subsidiaries: Sucampo Pharma Europe, Ltd., located in the UK; Sucampo Pharma, Ltd., located in Japan; and, Sucampo Pharma Americas, Inc., located in Maryland. To learn more about Sucampo Pharmaceuticals 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 | Nine Months Ended | |||||||||||||||
September 30, | September 30, | |||||||||||||||
2009 | 2008 | 2009 | 2008 | |||||||||||||
Revenues: | ||||||||||||||||
Research and development revenue | $ | 7,045 | $ | 5,436 | $ | 19,966 | $ | 66,982 | ||||||||
Product royalty revenue | 9,367 | 7,718 | 27,227 | 24,699 | ||||||||||||
Co-promotion revenue | 1,266 | 1,185 | 3,406 | 3,643 | ||||||||||||
Contract and collaboration revenue | 153 | 142 | 451 | 425 | ||||||||||||
Total revenues | 17,831 | 14,481 | 51,050 | 95,749 | ||||||||||||
Operating expenses: | ||||||||||||||||
Research and development | 7,383 | 11,390 | 26,969 | 35,537 | ||||||||||||
General and administrative | 4,317 | 3,863 | 10,696 | 10,591 | ||||||||||||
Selling and marketing | 3,047 | 2,680 | 7,747 | 8,398 | ||||||||||||
Milestone royalties - related parties | - | - | 875 | 3,531 | ||||||||||||
Product royalties - related parties | 1,664 | 1,359 | 4,837 | 4,391 | ||||||||||||
Total operating expenses | 16,411 | 19,292 | 51,124 | 62,448 | ||||||||||||
Income (loss) from operations | 1,420 | (4,811 | ) | (74 | ) | 33,301 | ||||||||||
Non-operating income (expense): | ||||||||||||||||
Interest income | 211 | 655 | 742 | 1,862 | ||||||||||||
Other expense, net | (250 | ) | (15 | ) | (36 | ) | (16 | ) | ||||||||
Total non-operating income (expense), net | (39 | ) | 640 | 706 | 1,846 | |||||||||||
Income (loss) before income taxes | 1,381 | (4,171 | ) | 632 | 35,147 | |||||||||||
Income tax benefit (provision) | (1,469 | ) | 1,745 | (2,733 | ) | (7,192 | ) | |||||||||
Net income (loss) | $ | (88 | ) | $ | (2,426 | ) | $ | (2,101 | ) | $ | 27,955 | |||||
Net income (loss) per share: | ||||||||||||||||
Basic net income (loss) per share | $ | - | $ | (0.06 | ) | $ | (0.05 | ) | $ | 0.67 | ||||||
Diluted net income (loss) per share | $ | - | $ | (0.06 | ) | $ | (0.05 | ) | $ | 0.67 | ||||||
Weighted average common shares outstanding - basic | 41,844 | 41,813 | 41,844 | 41,768 | ||||||||||||
Weighted average common shares outstanding - diluted | 41,844 | 41,813 | 41,844 | 42,022 |
Sucampo Pharmaceuticals, Inc. | ||||||
Consolidated Balance Sheets (unaudited) | ||||||
(in thousands, except share data) | ||||||
September 30, | December 31, | |||||
2009 |
2008 | |||||
ASSETS: | ||||||
Current assets: | ||||||
Cash and cash equivalents | $ | 31,751 | $ | 11,536 | ||
Investments, current | 53,038 | 93,776 | ||||
Product royalties receivable | 9,368 | 9,725 | ||||
Unbilled accounts receivable | 828 | 4,373 | ||||
Accounts receivable | 1,350 | 878 | ||||
Prepaid and income taxes receivable | - | 133 | ||||
Deferred tax assets, net | 190 | 963 | ||||
Prepaid expenses and other current assets | 3,447 | 3,641 | ||||
Total current assets | 99,972 | 125,025 | ||||
Investments, non-current | 38,853 | 16,222 | ||||
Property and equipment, net | 2,357 | 2,275 | ||||
Deferred tax assets, non-current | 4,216 | 4,026 | ||||
Other assets | 4,339 | 3,246 | ||||
Total assets | $ | 149,737 | $ | 150,794 | ||
LIABILITIES AND STOCKHOLDERS' EQUITY: |
||||||
Current liabilities: | ||||||
Accounts payable | $ | 2,122 | $ | 1,433 | ||
Accrued expenses | 9,414 | 9,764 | ||||
Deferred revenue, current | 13,499 | 15,599 | ||||
Income taxes payable | 313 | - | ||||
Total current liabilities | 25,348 | 26,796 | ||||
Deferred revenue, non-current | 10,217 | 8,061 | ||||
Other liabilities | 2,110 | 2,147 | ||||
Total liabilities | 37,675 | 37,004 | ||||
Commitments |
||||||
Stockholders' equity: | ||||||
Preferred stock, $0.01 par value; $5,000,000 shares authorized at September 30, 2009 and December 31, 2008; no shares issued and outstanding at September 30, 2009 and December 31, 2008 |
- | - | ||||
Class A common stock, $0.01 par value; 270,000,000 shares authorized at September 30, 2009 and December 31, 2008; 15,654,258 and 15,651,849 shares issued and outstanding at September 30, 2009 and December 31, 2008, respectively |
156 | 156 | ||||
Class B common stock, $0.01 par value; 75,000,000 shares authorized at September 30, 2009 and December 31, 2008; 26,191,050 shares issued and outstanding at September 30, 2009 and December 31, 2008, respectively |
262 | 262 | ||||
Additional paid-in capital |
98,516 | 98,243 | ||||
Accumulated other comprehensive income | 454 | 354 | ||||
Retained earnings | 12,674 | 14,775 | ||||
Total stockholders' equity | 112,062 | 113,790 | ||||
Total liabilities and stockholders' equity | $ | 149,737 | $ | 150,794 |
Sucampo Pharmaceuticals, Inc. | ||||||||||||||||||||
Key Segment Information (unaudited) | ||||||||||||||||||||
(in thousands) | ||||||||||||||||||||
Intercompany | ||||||||||||||||||||
Americas | Europe | Asia | Eliminations | Consolidated | ||||||||||||||||
Three Months Ended September 30, 2009 | ||||||||||||||||||||
Research and development revenue | $ | 3,562 | $ | - | $ | 3,483 | $ | - | $ | 7,045 | ||||||||||
Product royalty revenue | 9,367 | - | - | - | 9,367 | |||||||||||||||
Co-promotion revenue | 1,266 | - | - | - | 1,266 | |||||||||||||||
Contract and collaboration revenue | 141 | - | 282 | (270 | ) | 153 | ||||||||||||||
Total revenues | 14,336 | - | 3,765 | (270 | ) | 17,831 | ||||||||||||||
Research and development expenses | 3,040 | 459 | 3,884 | - | 7,383 | |||||||||||||||
Depreciation and amortization | 213 | 3 | 7 | - | 223 | |||||||||||||||
Other operating expenses | 7,790 | 1,029 | 256 | (270 | ) | 8,805 | ||||||||||||||
Income (loss) from operations | 3,293 | (1,491 | ) | (382 | ) | - | 1,420 | |||||||||||||
Interest income | 277 | - | 2 | (68 | ) | 211 | ||||||||||||||
Other non-operating expense, net | (17 | ) | (22 | ) | (279 | ) | 68 | (250 | ) | |||||||||||
Income (loss) before income taxes | $ | 3,553 | $ | (1,513 | ) | $ | (659 | ) | $ | - | $ | 1,381 | ||||||||
Capital expenditures | $ | 64 | $ | - | $ | 87 | $ | - | $ | 151 | ||||||||||
Three Months Ended September 30, 2008 | ||||||||||||||||||||
Research and development revenue | $ | 5,436 | $ | - | $ | - | $ | - | $ | 5,436 | ||||||||||
Product royalty revenue | 7,718 | - | - | - | 7,718 | |||||||||||||||
Co-promotion revenue | 1,185 | - | - | - | 1,185 | |||||||||||||||
Contract and collaboration revenue | 142 | - | 213 | (213 | ) | 142 | ||||||||||||||
Total revenues | 14,481 | - | 213 | (213 | ) | 14,481 | ||||||||||||||
Research and development expenses | 10,217 | 330 | 843 | - | 11,390 | |||||||||||||||
Depreciation and amortization | 110 | 1 | 3 | - | 114 | |||||||||||||||
Other operating expenses | 7,602 | 139 | 257 | (210 | ) | 7,788 | ||||||||||||||
Income (loss) from operations | (3,448 | ) | (470 | ) | (890 | ) | (3 | ) | (4,811 | ) | ||||||||||
Interest income | 678 | 1 | 2 | (26 | ) | 655 | ||||||||||||||
Other non-operating expense, net | (6 | ) | (17 | ) | (21 | ) | 29 | (15 | ) | |||||||||||
Income (loss) before income taxes | $ | (2,776 | ) | $ | (486 | ) | $ | (909 | ) | $ | - | $ | (4,171 | ) | ||||||
Capital expenditures | $ | 5 | $ | 35 | $ | - | $ | - | $ | 40 | ||||||||||
Nine Months Ended September 30, 2009 | ||||||||||||||||||||
Research and development revenue | $ | 12,539 | $ | - | $ | 7,427 | $ | - | $ | 19,966 | ||||||||||
Product royalty revenue | 27,227 | - | - | - | 27,227 | |||||||||||||||
Co-promotion revenue | 3,406 | - | - | - | 3,406 | |||||||||||||||
Contract and collaboration revenue | 424 | - | 717 | (690 | ) | 451 | ||||||||||||||
Total revenues | 43,596 | - | 8,144 | (690 | ) | 51,050 | ||||||||||||||
Research and development expenses | 16,398 | 788 | 9,783 | - | 26,969 | |||||||||||||||
Depreciation and amortization | 512 | 9 | 11 | - | 532 | |||||||||||||||
Other operating expenses | 20,851 | 1,659 | 1,803 | (690 | ) | 23,623 | ||||||||||||||
Income (loss) from operations | 5,835 | (2,456 | ) | (3,453 | ) | - | (74 | ) | ||||||||||||
Interest income | 928 | - | 4 | (190 | ) | 742 | ||||||||||||||
Other non-operating expense, net | 191 | (392 | ) | (25 | ) | 190 | (36 | ) | ||||||||||||
Income (loss) before income taxes | $ | 6,954 | $ | (2,848 | ) | $ | (3,474 | ) | $ | - | $ | 632 | ||||||||
Capital expenditures | $ | 3,259 | $ | 3 | $ | 116 | $ | - | $ | 3,378 | ||||||||||
Nine Months Ended September 30, 2008 | ||||||||||||||||||||
Research and development revenue | $ | 66,982 | $ | - | $ | - | $ | - | $ | 66,982 | ||||||||||
Product royalty revenue | 24,699 | - | - | - | 24,699 | |||||||||||||||
Co-promotion revenue | 3,643 | - | - | - | 3,643 | |||||||||||||||
Contract and collaboration revenue | 425 | - | 630 | (630 | ) | 425 | ||||||||||||||
Total revenues | 95,749 | - | 630 | (630 | ) | 95,749 | ||||||||||||||
Research and development expenses | 29,976 | 1,703 | 3,858 | - | 35,537 | |||||||||||||||
Depreciation and amortization | 318 | 1 | 7 | - | 326 | |||||||||||||||
Other operating expenses | 25,348 | 1,188 | 679 | (630 | ) | 26,585 | ||||||||||||||
Income (loss) from operations | 40,107 | (2,892 | ) | (3,914 | ) | - | 33,301 | |||||||||||||
Interest income | 1,924 | 6 | 5 | (73 | ) | 1,862 | ||||||||||||||
Other non-operating expense, net | (39 | ) | (30 | ) | (20 | ) | 73 | (16 | ) | |||||||||||
Income (loss) before income taxes | $ | 41,992 | $ | (2,916 | ) | $ | (3,929 | ) | $ | - | $ | 35,147 | ||||||||
Capital expenditures | $ | 304 | $ | 35 | $ | 3 | $ | - | $ | 342 |
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