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TheStreet Open House

Sucampo Pharmaceuticals, Inc. Reports Fourth Quarter And Full Year 2013 Financial And Operating Results

Full Year Net Income Excluding Special Items of $9.4 Million, Up 94% over 2012 and Exceeds Guidance

Company to Host Conference Call Today at 5:00 pm Eastern

BETHESDA, Md., Feb. 26, 2014 (GLOBE NEWSWIRE) -- Sucampo Pharmaceuticals, Inc. (Sucampo) (Nasdaq:SCMP), a global biopharmaceutical company, today reported consolidated financial results for the fourth quarter and full year ending December 31, 2013, with earnings that exceeded Sucampo's previously-issued guidance.

Financial Highlights for the Fourth Quarter of 2013

  • Net Income excluding Special Items was $2.4 million compared to $13.5 million in the same period in 2012. GAAP net income was $2.2 million compared to $13.5 million in the same period in 2012. The decrease was due to the receipt of a $15.0 million milestone in the fourth quarter of 2012 that did not occur in 2013.
  • Total revenues were $24.5 million, compared to $34.9 million in the same period in 2012. The decrease in revenue compared to the prior year was driven by the receipt of a $15.0 million milestone payment in the fourth quarter of 2012 associated with the launch of AMITIZA ® (lubiprostone) in Japan. Excluding the impact of the milestone payment, revenue increased $4.6 million in the fourth quarter of 2013 versus the prior year.
  • United States (U.S.) net sales of AMITIZA, as reported to us by our partner, Takeda Pharmaceuticals U.S.A., Inc. (Takeda), for royalty calculation purposes, increased 4.6% to $78.0 million in the fourth quarter of 2013, compared to $74.6 million in the same period of 2012.
  • Diluted earnings per share excluding Special Items were $0.06 compared to $0.32 in the same period in 2012. GAAP diluted earnings per share (EPS) were $0.05 compared to $0.32 in the same period in 2012.

Financial Highlights for the Full Year of 2013

  • Net Income excluding Special Items was up 94% to $9.4 million compared to $4.8 million in the same period in 2012. GAAP net income was $6.4 million compared to $4.8 million in the same period in 2012.
  • Total revenues were $89.6 million compared to $81.5 million in the same period in 2012, a growth rate of 9.9%.
  • U.S. net sales of AMITIZA, as reported to us by our partner, Takeda, for royalty calculation purposes, increased 3.8% to $282.1 million for 2013, compared to $271.9 million for 2012.
  • Diluted earnings per share excluding Special Items were $0.22 compared to $0.12 in the same period in 2012. GAAP diluted EPS were $0.15 compared to $0.12 in the same period in 2012.
  Three Months Ended December 31, Year Ended December 31,
(In thousands, except per share data) 2013 2013
Total revenues  $ 24,490  $ 89,594
GAAP Diluted EPS  0.05  0.15
Non-GAAP Diluted EPS that exclude RESCULA inventory/samples non-cash write-off and restructuring costs 1  0.06  0.22
GAAP net income 2  2,153  6,419
Non-GAAP net income that excludes RESCULA inventory/samples non-cash write-off and restructuring costs 1, 2  2,420  9,402

1. Sucampo is providing certain 2013 non-GAAP information that excludes certain items because of the nature of these items and the impact they have on the analysis of underlying business performance and trends. Management believes that providing this information enhances investors' understanding of Sucampo's performance. This information should be considered in addition to, but not in lieu of, information prepared in accordance with GAAP.

2. Net income is attributable to Sucampo Pharmaceuticals, Inc. on a consolidated basis.

"2013 was a year of significant growth for Sucampo," said Ryuji Ueno, M.D., Ph.D., Ph.D., the company's co-founder, who as previously reported is stepping down as Chairman and member of the Board of Directors (Board) and Chief Executive Officer (CEO) on March 3, 2014 and as Chief Scientific Officer (CSO) on March 31, 2014. "AMITIZA received approval as the first and only oral prescription treatment option for opioid induced constipation (OIC) in adult patients with chronic, non-cancer pain, bringing an important new treatment to patients who suffer from this debilitating side effect of chronic opioid use. Sales for AMITIZA continued to increase in Japan, and with the launch of AMITIZA for chronic idiopathic constipation (CIC) in Switzerland, Sucampo is now recognizing revenue on three continents. We also made important progress in making RESCULA ® (unoprostone isopropyl) commercially available in the U.S., and we made important advances in our clinical development programs. As I prepare to transition out of my roles as CEO, member and Chairman of the Board and CSO with Sucampo, I am confident that under the leadership of the new CEO, we are well-positioned to accelerate our legacy of growth."

Fourth Quarter 2013 and Recent Highlights

AMITIZA in the U.S.

  • AMITIZA total prescriptions increased 5% in 2013 and 6% in the fourth quarter. Total prescriptions of AMITIZA in 2013 were 1.3 million, the highest total in one year ever recorded for AMITIZA. Fourth quarter total prescriptions of AMITIZA were 341,000, making the fourth quarter in 2013 the highest ever.  
  • Among pain specialists, the monthly average total prescriptions for AMITIZA increased 31% since OIC approval in April and through the month of December, as compared to the eight months prior to approval.  
  • AMITIZA maintained a preferred managed care position, with 90% of insured lives covered nationally.

AMITIZA in Global Markets

  • Sucampo revenue from sales of AMITIZA in Japan was $5.1 million in the fourth quarter of 2013, an increase of $0.1 million versus Q4 2012 which was the initial inventory stocking quarter for the product launch. For 2013, Sucampo revenue from sales of AMITIZA in Japan was $15.8 million, an increase of 215% versus 2012, in which AMITIZA was launched in late November.  
  • Sucampo made AMITIZA available in the United Kingdom (U.K.) in the latter half of the fourth quarter of 2013.  
  • In Switzerland, Sucampo showed sequential quarterly sales growth for AMITIZA for CIC. Additionally, in February, Sucampo announced that the Bundesamt für Gesundheit (BAG) in Switzerland revised several limitations with which AMITIZA was first approved for reimbursement and inclusion in its specialty list, allowing all Swiss physicians to prescribe AMITIZA, not just Swiss gastroenterologists, and increasing the maximum treatment duration of AMITIZA from 12 to 52 weeks before a review is needed by a health insurance health care practitioner.  
  • Sucampo continued partnership discussions for strategic alliances for AMITIZA for global markets outside of the U.S. and Japan, including China, Russia, Europe, Latin America and emerging markets.

Research & Development

  • In December, Sucampo announced the initiation of a global pivotal phase 3 clinical program of lubiprostone in pediatric functional constipation, with the anticipation of the first patient to roll over into a long-term safety extension study within the first half of 2014. Sucampo plans to initiate another well-controlled study in younger children with pediatric functional constipation following successful completion of the adult study of the liquid formulation, which is expected within the first half of 2014.  
  • Also in December, Sucampo announced the results of its double-blind, placebo-controlled phase 2a proof of concept study evaluating an intravenous (IV) formulation of our proprietary ion channel activator in patients with lumbar spinal stenosis (LSS), a degenerative disease of the lumbar spine. A responder analysis of data from the trial revealed that patients receiving the ion channel activator experienced a statistically significant improvement in pain, as determined by improvements in the Visual Analog Scale (VAS) pain score, versus placebo (94.4% versus 62.5%; p=0.035). Sucampo plans to conduct an additional phase 2a study in the second half of 2014 to evaluate the clinical effectiveness of the IV ion channel activator. Sucampo also plans to initiate a phase 1b study in the first quarter of 2014 for its oral ion channel activator for LSS.  
  • In October, Sucampo announced that its development partner, R-Tech Ueno Ltd., completed patient enrollment of a phase 3 clinical trial for unoprostone isopropyl for retinitis pigmentosa in Japan. A substantial portion of the development costs for the program are being funded by the Japan Science and Technology Agency. Sucampo has rights to the clinical data for potential filing in Europe and the U.S., where unoprostone isopropyl has orphan drug designation, and Sucampo will decide on future development assuming the Japanese trial is successful.  
  • Sucampo initiated a phase 1b trial for cobiprostone for the treatment of oral mucositis, a debilitating side effect of chemotherapy and radiation therapy in cancer patients, in the fourth quarter of 2013.

Corporate

  • Sucampo recently announced that Peter Greenleaf will join Sucampo as CEO and a member of the Board on March 3. Dr. Ueno will step down as CEO and member and Chairman of the Board on March 3, and as CSO on March 31. Dan Getman, Ph.D., will become Chairman of the Board on March 3.  
  • Dr. Ueno, as the Co-founder, Chairman Emeritus and Scientific Advisor, will provide consulting services to Sucampo on the development of its pipeline and other strategic activities.
2013 Value Drivers:  
   
Sucampo achieved eleven (denoted with a +) of its thirteen value drivers for 2013; unchecked items are still in progress:
   
AMITIZA  
   
U.S.  
+ Achieved approval of the OIC indication for AMITIZA in the U.S.  
+ Received a $10.0 million milestone payment from Takeda upon the approval and first commercial sale of AMITIZA for OIC in the U.S.
   
Global  
• Engaging in discussions for strategic alliances for AMITIZA for new indications and new territories outside of the U.S., including Latin America, China, Russia, Europe and emerging markets
   
Japan  
+ Strong sales growth of AMITIZA  
   
Europe  
+ Began active marketing of AMITIZA for CIC in Switzerland  
+ Completed in the first half of 2013 the submission for regulatory approval of AMITIZA in the U.K. and Switzerland for the treatment of OIC. Sucampo anticipates approval from each respective regulatory authority in the first half of 2014 
• Submission of filings via the mutual recognition procedure (MRP) for AMITIZA in other European markets following the U.K. OIC approval
+ Filed for National Institute for Health and Care Excellence endorsement for CIC and OIC and launched AMITIZA in the U.K.  
   
RESCULA  
+ Launched RESCULA in February in the U.S.   
   
Pipeline  
   
Lubiprostone  
+ Achieved First Patient First Visit in our AMITIZA phase 3 trial for pediatric functional constipation in the second half of 2013   
   
Oral Mucositis  
+ Completed our oral mucositis phase 1a trial for cobiprostone in the second quarter of 2013  
+ Initiated a phase 1b trial for cobiprostone on October 31  
   
Spinal Stenosis  
+ Completed our spinal stenosis phase 2a, double-blind, placebo-controlled trial for our IV ion channel activator for LSS  

Financial Results for the Quarter

For the fourth quarter of 2013, Sucampo reported total revenue of $24.5 million compared to $34.9 million for the same period in 2012, a decrease of approximately 29.8% or $10.4 million. The decrease in revenue compared to the prior year was primarily driven by the receipt of a $15.0 million milestone payment in the fourth quarter of 2012 associated with the launch of AMITIZA in Japan. Excluding the impact of the milestone payment, revenue increased $4.6 million in the fourth quarter of 2013 versus the prior year. The key components of revenue for the fourth quarter included R&D revenue of $4.1 million, product royalty revenue of $14.8 million, product sales revenue of $5.4 million and co-promotion revenue of nil which compare to $15.1 million, $14.2 million and $5.0 million and $0.3 million, respectively, in the same period of 2012.

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