BETHESDA, Md.--(BUSINESS WIRE)-- Sucampo Pharmaceuticals, Inc. (NASDAQ: SCMP) today reported its consolidated financial results for the quarter and six months ended June 30, 2010.
Sucampo reported a net loss of $2.0 million, or $0.05 per diluted share, for the second quarter of 2010, compared to a net loss of $0.2 million, or $0.01 per diluted share, for the same period in 2009. Sucampo reported a net loss of $2.3 million, or $0.05 per diluted share, for the first six months of 2010, compared to a net loss of $2.0 million, or $0.05 per diluted share, for the same period in 2009.
“We are making progress with our pipeline and are pleased to confirm our decision to conduct another phase 3 efficacy study of Amitiza® for the treatment of opioid-induced bowel dysfunction. We also continue to advance in our design of two phase 2 trials of Rescula® for retinitis pigmentosa and dry age-related macular degeneration,” said James J. Egan, Chief Operating Officer. “In addition, we continue to work towards resolution of our ongoing dispute with Takeda Pharmaceuticals.”
Financial Results for the Quarter and Year-to-Date
For the second quarter of 2010, Sucampo reported total revenue of $13.8 million, compared to $17.7 million for the same period in 2009. For the first six months of 2010, Sucampo reported total revenue of $28.6 million, compared to $33.2 million for the same period in 2009. The decreases were mainly a result of lower R&D revenue recognized for the opioid-induced bowel dysfunction (OBD) trials of Amitiza in the U.S. funded by Takeda Pharmaceutical Company (Takeda) as well as reduced revenue recognized under the agreement with Abbott related to Amitiza development in Japan. These R&D revenues were partially offset by a slight increase in product royalty revenue.
Key components of total revenue in the second quarter of 2010 included R&D revenue of $2.8 million and product royalty revenue of $9.6 million, compared to $7.4 million and $8.9 million, respectively, for the same period in 2009. Total revenue for the first six months of 2010 included R&D revenue of $6.8 million and product royalty revenue of $19.4 million, compared to $12.9 million and $17.9 million, respectively, for the same period in 2009. The decrease in R&D revenue is in line with the completion of two phase 3 trials of Amitiza for OBD in 2009 funded by Takeda and the change in estimated costs and timeline to complete the OBD program, including an additional phase 3 efficacy trial. Furthermore, the reduced R&D revenue recognized under our agreement with Abbott in Japan reflects the progress of the phase 3 program in Japan for the respective periods. The increase in product royalty revenue was in line with the increase in net sales as reported by Takeda which increased to $53.4 million for the second quarter 2010, compared to $49.5 million in the same period in 2009. The increase in net sales was primarily a result of a mid-2009 price increase for Amitiza and slightly higher sales volume.
R&D expenses were $4.9 million in the second quarter of 2010, compared to $9.6 million for the same period in 2009. R&D expenses were $10.2 million for the first six months of 2010, compared to $19.6 million for the same period in 2009. The decrease in R&D expenses resulted primarily from the completion in July 2009 of two phase 3 clinical trials of Amitiza for OBD, the completion in July 2009 of the phase 2 trial of cobiprostone for the prevention of non-steroidal anti-inflammatory drug (NSAID)-induced gastrointestinal injury as well as reduced costs related to development of SPI-017.
G&A expenses were $6.6 million in the second quarter of 2010, compared to $2.9 million for the same period in 2009. G&A expenses were $12.4 million for the first six months of 2010, compared to $6.4 million for the same period in 2009. The increase in G&A expenses are due mainly to costs incurred in connection with ongoing legal matters.
Selling and marketing expenses were $2.3 million in the second quarter of 2010, compared to $2.2 million for the same period in 2009. Selling and marketing expenses were $4.5 million for the first six months of 2010, compared to $4.7 million for the same period in 2009.
Cash, Cash Equivalents and Marketable Securities
At June 30, 2010, cash, cash equivalents and investments were $114.4 million, compared to $118.3 million at December 31, 2009. This slight decrease was mainly due to the use of cash in operating activities.
Second Quarter and Recent Highlights
Takeda Dispute Update
As previously reported, Sucampo submitted for filing with the International Court of Arbitration, International Chamber of Commerce a demand for arbitration under the applicable provisions of the Collaboration and License Agreement between the Company and Takeda dated October 29, 2004. The respective arbitrators for both Sucampo and Takeda have been confirmed and both parties have selected a third arbitrator. If the third arbitrator is confirmed, then it will comprise the panel that will conduct the arbitration proceedings.
Company to Host Conference Call Today
In conjunction with its second quarter 2010 financial results announcement, Sucampo will host a conference call at 5:00 p.m. Eastern today. To participate on the live call, please dial 800-901-5213 (domestic) or 1-617-786-2962 (international), and provide the participant passcode 65816177, 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 25487845.
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 occur naturally in the human body as a result of enzymatic (15-PGDH) transformation of certain fatty acids, 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 Advisor, International Business Development and a member of the Board of Directors. For more information about Sucampo Pharmaceuticals, please visit www.sucampo.com.
Amitiza® is a registered trademark of Sucampo Pharmaceuticals, Inc. Rescula® is a registered trademark of R-Tech Ueno, Ltd. and has been licensed to Sucampo for use in the U.S. and Canada.
About Amitiza (lubiprostone) for Chronic Idiopathic Constipation and Irritable Bowel Syndrome with Constipation
Amitiza (lubiprostone) is indicated for the treatment of CIC (24 mcg twice daily) in adults and for IBS-C (8 mcg twice daily) in women ≥18 years of age and older.
Amitiza is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction. Patients with symptoms suggestive of mechanical gastrointestinal obstruction should be thoroughly evaluated by the treating healthcare provider to confirm the absence of such an obstruction prior to initiating Amitiza treatment.
The safety of Amitiza in pregnancy has not been evaluated in humans. Amitiza should be used during pregnancy only if the benefit justifies the potential risk to the fetus. Women who could become pregnant should have a negative pregnancy test prior to beginning therapy with Amitiza and should be capable of complying with effective contraceptive measures.
Patients taking Amitiza may experience nausea. If this occurs, concomitant administration of food with Amitiza may reduce symptoms of nausea. Patients who experience severe nausea should inform their healthcare provider.
Amitiza should not be prescribed to patients that have severe diarrhea. Patients should be aware of the possible occurrence of diarrhea during treatment and inform their healthcare provider if the diarrhea becomes severe.
Patients taking Amitiza may experience dyspnea within an hour of first dose. This symptom generally resolves within three hours, but may recur with repeat dosing. Patients who experience dyspnea should inform their healthcare provider. Some patients have discontinued therapy because of dyspnea.
In clinical trials of Amitiza (24 mcg twice daily vs. placebo: N=1113 vs. N=316) in patients with CIC, the most common adverse reactions (incidence >4%) were nausea (29% vs. 3%), diarrhea (12% vs. 1%), headache (11% vs. 5%), abdominal pain (8% vs. 3%), abdominal distention (6% vs. 2%), and flatulence (6% vs. 2%).
In clinical trials of Amitiza (8 mcg twice daily vs. placebo: N=1011 vs. N=435) in patients with IBS-C, the most common adverse reactions (incidence >4%) were nausea (8% vs. 4%), diarrhea (7% vs. 4%), and abdominal pain (5% vs. 5%).
Please see complete Prescribing Information at www.amitiza.com.
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. Forward-looking statements include statements about the potential utility of Amitiza and Rescula to treat particular indications or conditions, including the potential utility of lubiprostone to treat chronic idiopathic constipation in Japanese patients, and future clinical trials and of unoprostone to treat retinitis pigmentosa and dry AMD and future clinical trials. 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, 2009 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 data. Sucampo does not undertake any obligation to update any forward-looking statements contained in this release as a result of new information, future events or otherwise, except as required by law.
|Sucampo Pharmaceuticals, Inc.|
|Condensed Consolidated Statements of Operations (unaudited)|
|(in thousands, except per share data)|
|Three Months Ended June 30,||Six Months Ended June 30,|
|Research and development revenue||$||2,789||$||7,395||$||6,846||$||12,921|
|Product royalty revenue||9,612||8,914||19,385||17,860|
|Contract and collaboration revenue||154||152||305||298|
|Research and development||4,854||9,621||10,220||19,586|
|General and administrative||6,604||2,924||12,363||6,379|
|Selling and marketing||2,313||2,188||4,500||4,700|
|Milestone royalties - related parties||-||375||-||875|
|Product royalties - related parties||1,709||1,583||3,446||3,173|
|Total operating expenses||15,480||16,691||30,529||34,713|
|Loss from operations||(1,705||)||1,014||(1,918||)||(1,494||)|
|Non-operating income (expense):|
|Other income (expense), net||(135||)||(608||)||(227||)||214|
|Total non-operating income (loss), net||42||(389||)||161||745|
|Income (loss) before income taxes||(1,663||)||625||(1,757||)||(749||)|
|Income tax provision||(315||)||(863||)||(520||)||(1,264||)|
|Net loss per share:|
|Basic net loss per share||$||(0.05||)||$||(0.01||)||$||(0.05||)||$||(0.05||)|
|Diluted net loss per share||$||(0.05||)||$||(0.01||)||$||(0.05||)||$||(0.05||)|
|Weighted average common shares outstanding - basic||41,848||41,844||41,847||41,844|
|Weighted average common shares outstanding - diluted||41,848||41,844||41,847||41,844|
|Sucampo Pharmaceuticals, Inc.|
|Condensed Consolidated Balance Sheets (unaudited)|
|(in thousands, except share data)|
|Cash and cash equivalents||$||42,293||$||26,714|
|Product royalties receivable||9,612||11,023|
|Unbilled accounts receivable||16||644|
|Accounts receivable, net||889||512|
|Deferred tax assets, net||135||315|
|Prepaid expenses and other current assets||2,209||3,137|
|Total current assets||111,317||114,779|
|Property and equipment, net||2,117||2,242|
|Deferred tax assets, non-current||4,255||3,995|
|LIABILITIES AND STOCKHOLDERS' EQUITY:|
|Deferred revenue, current||4,298||10,565|
|Income taxes payable||428||349|
|Total current liabilities||15,002||20,654|
|Deferred revenue, non-current||8,296||8,643|
Preferred stock, $0.01 par value; 5,000,000 shares authorized at June 30, 2010 and December 31, 2009;
no shares issued and outstanding at June 30, 2010 and December 31, 2009
Class A common stock, $0.01 par value; 270,000,000 shares authorized at June 30, 2010 and December 31, 2009;
15,657,937 and 15,655,730 shares issued and outstanding at June 30, 2010 and December 31, 2009, respectively
Class B common stock, $0.01 par value; 75,000,000 shares authorized at June 30, 2010 and December 31, 2009;
26,191,050 shares issued and outstanding at June 30, 2010 and December 31, 2009, respectively
|Additional paid-in capital||99,346||98,636|
|Accumulated other comprehensive income||277||484|
|Total stockholders' equity||111,779||113,553|
|Total liabilities and stockholders' equity||$||137,175||$||144,971|
|Sucampo Pharmaceuticals, Inc.|
|Key Segment Information (unaudited)|
|Three Months Ended June 30, 2010|
|Research and development revenue||$||1,269||$||-||$||1,520||$||-||$||2,789|
|Product royalty revenue||9,612||-||-||-||9,612|
|Contract and collaboration revenue||141||-||285||(272||)||154|
|Research and development expenses||1,996||142||2,988||(272||)||4,854|
|Depreciation and amortization||222||3||6||-||231|
|Other operating expenses||9,707||468||220||-||10,395|
|Income (loss) from operations||317||(613||)||(1,409||)||-||(1,705||)|
|Other non-operating income (expense), net||3||(49||)||(167||)||78||(135||)|
|Income (loss) before income taxes||$||574||$||(662||)||$||(1,575||)||$||-||$||(1,663||)|
|Six Months Ended June 30, 2010|
|Research and development revenue||$||2,573||$||-||$||4,273||$||-||$||6,846|
|Product royalty revenue||19,385||-||-||-||19,385|
|Contract and collaboration revenue||282||-||570||(547||)||305|
|Research and development expenses||4,369||361||6,037||(547||)||10,220|
|Depreciation and amortization||440||6||13||-||459|
|Other operating expenses||18,712||720||418||-||19,850|
|Income (loss) from operations||794||(1,087||)||(1,625||)||-||(1,918||)|
|Other non-operating income (expense), net||(33||)||(148||)||(187||)||141||(227||)|
|Income (loss) before income taxes||$||1,288||$||(1,235||)||$||(1,810||)||$||-||$||(1,757||)|
|Three Months Ended June 30, 2009|
|Research and development revenue||$||3,825||$||-||$||3,570||$||-||$||7,395|
|Product royalty revenue||8,914||-||-||-||8,914|
|Contract and collaboration revenue||142||-||220||(210||)||152|
|Research and development expenses||5,807||177||3,847||(210||)||9,621|
|Depreciation and amortization||182||3||2||-||187|
|Other operating expenses||6,154||302||427||-||6,883|
|Income (loss) from operations||1,982||(482||)||(486||)||-||1,014|
|Other non-operating income (expense), net||(36||)||(334||)||(310||)||72||(608||)|
|Income (loss) before income taxes||$||2,238||$||(816||)||$||(797||)||$||-||$||625|
|Six Months Ended June 30, 2009|
|Research and development revenue||$||8,977||$||-||$||3,944||$||-||$||12,921|
|Product royalty revenue||17,860||-||-||-||17,860|
|Contract and collaboration revenue||283||-||435||(420||)||298|
|Research and development expenses||13,778||329||5,899||(420||)||19,586|
|Depreciation and amortization||299||6||4||-||309|
|Other operating expenses||12,641||630||1,547||-||14,818|
|Income (loss) from operations||2,542||(965||)||(3,071||)||-||(1,494||)|
|Other non-operating income (expense), net||208||(370||)||254||122||214|
|Income (loss) before income taxes||$||3,401||$||(1,335||)||$||(2,815||)||$||-||$||(749||)|
Sucampo Pharmaceuticals, Inc.
Kate de Santis, 240-223-3834
John Woolford, 410-213-0506
KEYWORDS: United States North America Maryland
INDUSTRY KEYWORDS: Health Biotechnology Clinical Trials Pharmaceutical