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.

^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.

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.

For the full year 2013, Sucampo reported total revenue of $89.6 million, compared to $81.5 million for the full year 2012, a growth of approximately 9.9%. The key components of total revenue for the full year 2013 were product royalty revenue of $52.1 million, R&D revenue of $20.4 million, product sales revenue of $16.4 million and co-promotion revenue of $0.1 million which compare to $50.7 million, $21.5 million, $5.0 million and $3.6 million, respectively, for the full year 2012.

U.S. net sales of AMITIZA, as reported to us by our partner, Takeda, for royalty calculation purposes, increased 4.6% to $78.0 million for the fourth quarter of 2013 and 3.8% to $282.1 million for the full year 2013, compared to $74.6 million and $271.9 million respectively in the same periods of 2012.

Cost of Goods Sold

Cost of goods sold relates to purchase and distribution costs of Sucampo's products sold by Sucampo, including changes in inventory provisions for excess and obsolete inventory. Cost of goods sold were $2.9 million for the fourth quarter of 2013, compared to $3.0 million for the fourth quarter of 2012, a decrease of $0.1 million. Cost of goods sold were $12.4 million for the full year 2013, compared to $3.0 million for the prior year period, an increase of $9.4 million. The increase in cost of goods sold relates to drug product sales of AMITIZA in Japan and Europe and RESCULA in the U.S. During the full year of 2013, Sucampo recorded a non-cash write-off of its RESCULA inventory of $3.0 million to reflect excess quantities of dated product. The excess inventory was largely a result of the necessity to pre-order product in advance of FDA approval due to a planned change in manufacturing facility and lower than anticipated sales within the useful life of the dated product.

Operating Expenses

R&D expenses, comprised of expenses for clinical development of the lubiprostone pediatric indication and liquid formulation, phase 1 trial expenses for oral mucositis, and clinical development expenses for Sucampo's lumbar spinal stenosis program, were $7.0 million for the fourth quarter of 2013, compared to $7.1 million for the same period of 2012. For the full year 2013, R&D expenses were $21.5 million, compared to $21.3 million for the prior year period. The increase in expenses was primarily due to the higher costs associated with clinical development of Sucampo's phase 2a trial for lumbar spinal stenosis and of the lubiprostone pediatric indication and liquid formulation, partially offset by lower costs associated with Sucampo's terminated collaboration with Numab AG.

G&A expenses were $6.8 million for the fourth quarter of 2013, compared to $7.6 million for the same period of 2012, a decrease of $0.8 million or 10.3%. G&A expenses were $25.4 million for the full year 2013, compared to $30.2 million for the prior year period, a decrease of $4.7 million or 15.7%. For the full year period, the decrease in G&A expense was primarily due to lower legal, consulting and other professional expenses as a result of the conclusion of certain legal matters in 2012, as well as expense reductions from 2013 productivity initiatives.

S&M expenses were $5.1 million for the fourth quarter of 2013, compared to $4.2 million for the fourth quarter of 2012.Selling and marketing expenses were $21.1 million for the full year 2013 compared to $18.7 million for the prior year period. For the full year period, the increase in selling and marketing expenses relates primarily to launch and restructuring costs for RESCULA and a $1.5 million non-cash write-off recorded for excess RESCULA samples, partially offset by non-recurring pre-commercialization planning activities for AMITIZA and RESCULA that occurred in 2012 that did not occur in 2013.

Net Income

Net income for the fourth quarter was $2.2 million, compared to net income of $13.5 million for 2012. For the quarter, the decrease was due to the receipt of a $15 million milestone in the fourth quarter of 2012 that did not occur in 2013.  For the full year 2013, net income was $6.4 million, compared to net income of $4.8 million for 2012.

Earnings Excluding Special Items

Net income excluding special items for the fourth quarter of 2013 was $2.4 million, or $0.06 per diluted share, compared to net income of $13.5 million, or $0.32 per diluted share, in the fourth quarter of 2012. Net income excluding special items for the full year 2013 was $9.4 million, or $0.22 per diluted share, compared to net income of $4.8 million, or $0.12 per diluted share, for 2012.

Non-GAAP (generally accepted accounting principles) EPS for the fourth quarter and full year 2013 of $0.06 and $0.22, respectively, exclude RESCULA inventory, sample non-cash write-off costs, and restructuring costs.

A reconciliation of GAAP to non-GAAP net income and EPS is provided in the tables that follow.

^3.Represents the difference between calculated GAAP EPS and calculated non-GAAP EPS, which may be different than the amount calculated by dividing the impact of the excluded items by the weighted-average shares for the period.

Cash, Cash Equivalents, Restricted Cash and Marketable Securities

At December 31, 2013, cash, cash equivalents, restricted cash and investments were $95.9 million, compared to $91.4 million at December 31, 2012. At December 31, 2013, notes payable were $52.7 million, compared to $52.9 million at December 31, 2012, including current notes payable of $26.9 million at December 31, 2013, and $19.1 million at December 31, 2012.

Stock Repurchase Plan

During the full year 2013, Sucampo repurchased 67,762 shares at a cost of $0.3 million. During the fourth quarter, Sucampo made no share repurchases under this program. Since inception, Sucampo has repurchased approximately $2.3 million of its common stock.

Cantor Sales Agreement

As previously disclosed, on January 11, 2013, Sucampo entered into a sales agreement with Cantor Fitzgerald & Co. (Cantor Sales Agreement), which enables Sucampo to offer and sell shares of the Sucampo's class A common stock with aggregate class A common stock sales of up to $20.0 million, from time to time through Cantor Fitzgerald & Co. as our sales agent. Sales of class A common stock under the Cantor Sales Agreement are made in sales deemed to be "at-the-market" equity offerings as defined in Rule 415 promulgated under the Securities Act of 1933, as amended. Cantor Fitzgerald & Co. is entitled to receive a commission rate of 3.0% of gross sales in connection with the sale of Sucampo's class A common stock sold on Sucampo's behalf. From November 22, 2013 through December 31, 2013, Sucampo had sold through the Cantor Sales Agreement an aggregate of 749,383 shares of Sucampo's class A common stock, and received gross proceeds of approximately $5.3 million, before deducting issuance expenses.

Future Guidance

Sucampo today affirmed its earnings guidance for 2014. Sucampo expects to be profitable in 2014 and expects to issue more specific guidance soon.

Company to Host Conference Call Today

In conjunction with this fourth quarter financial and operating results press release, Sucampo will host a conference call today at 5:00 pm Eastern. To participate on the live call, please dial 877-280-4955 (domestic) or 857-244-7312 (international), and provide the participant passcode 98843095, 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 42236766.

Investors interested in accessing the live audio webcast of the teleconference may do so at http://investor.sucampo.com and should log on before the teleconference begins in order to download any software required. The archive of the teleconference will remain available for 30 days.

About lubiprostone (AMITIZA^®)

AMITIZA (lubiprostone) is a prostone, a locally acting chloride channel activator, indicated for the treatment of CIC in adults and OIC in adults with chronic, non-cancer pain (24 mcg twice daily) and for IBS-C (8 mcg twice daily) in women 18 years of age and older in the U.S. In Japan, lubiprostone (24 mcg twice daily) is indicated for the treatment of chronic constipation (excluding constipation caused by organic diseases). In Switzerland, lubiprostone (24 mcg twice daily) is indicated for the treatment of CIC. In the U.K., lubiprostone (24 mcg twice daily) is indicated for the treatment of CIC and associated symptoms in adults.

About unoprostone isopropyl (RESCULA^®)

In 2009 and 2011, Sucampo acquired development and commercialization rights to unoprostone isopropyl throughout the world except in Japan, Korea, Taiwan and the People's Republic of China. Unoprostone isopropyl 0.12% (trade named RESCULA) first received marketing authorization in 1994 in Japan and was subsequently approved in over 40 countries, including approval in 2000 by the FDA. RESCULA (unoprostone isopropyl ophthalmic solution) 0.15% is indicated for the lowering of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension in the U.S.

About Sucampo Pharmaceuticals, Inc.

Sucampo Pharmaceuticals, Inc. is focused on the discovery, development and commercialization of drugs based on ion channel activators knows as prostones. Discovered by the company's scientific founder, prostones are naturally occurring fatty acid metabolites with unique physiological activities. Sucampo has two marketed products – AMITIZA and RESCULA – and a pipeline of prostone-based product candidates in clinical development. A global company, Sucampo is headquartered in Bethesda, Maryland, and has operations in the U.K., Switzerland and Japan. For more information, please visit www.sucampo.com.

The Sucampo logo and the tagline, The Science of Innovation, are registered trademarks of Sucampo AG.

AMITIZA is a registered trademark of Sucampo AG. RESCULA is a registered trademark of R-Tech Ueno, Ltd, and has been licensed to Sucampo AG.

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Sucampo Forward-Looking Statement

This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements are based on management's current expectations and involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements. The forward-looking statements may include statements regarding product development, product potential, future financial and operating results, and other statements that are not historical facts. The following factors, among others, could cause actual results to differ from those set forth in the forward-looking statements: the impact of pharmaceutical industry regulation and health care legislation; Sucampo's ability to accurately predict future market conditions; dependence on the effectiveness of Sucampo's patents and other protections for innovative products; the risk of new and changing regulation and health policies in the U.S. and internationally and the exposure to litigation and/or regulatory actions.

No forward-looking statement can be guaranteed and actual results may differ materially from those projected. Sucampo undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Forward-looking statements in this presentation should be evaluated together with the many uncertainties that affect Sucampo's business, particularly those mentioned in the risk factors and cautionary statements in Sucampo's most recent Form 10-K as well as its fillings on Form 10-Q and 8-K, which Sucampo incorporates by reference.

CONTACT: Sucampo Pharmaceuticals, Inc.
         Silvia Taylor
         Senior Vice President, Investor Relations and
         Corporate Communications
         1-240-223-3718
         staylor@sucampo.com