|Summary of Results||Q3-16||% Increase / (Decrease)over Q3-15|
|Net Income GAAP||$8.1M||12||%|
|EPS GAAP - diluted||$||0.19||19||%|
|Adjusted Net Income||$12.4M||58||%|
|Adjusted EPS - diluted||$||0.28||68||%|
- Recently completed a settlement and license agreement with Dr. Reddy's Laboratories, Ltd. and certain of its affiliates (Dr. Reddy's) that resolves patent litigation in the United States related to Sucampo's AMITIZA (lubiprostone) 8 mcg and 24 mcg soft gelatin capsules. The agreement provides for an entry date more than six years from today's date and profit sharing on product sales by Dr. Reddy's.
- A phase 3 trial of AMITIZA in pediatric functional constipation in children six to seventeen years of age did not achieve its primary endpoint of overall spontaneous bowel movement (SBM) response. However, the trial did show a trend in favor of lubiprostone for the primary endpoint, and achieved statistical significance in some secondary endpoints, notably overall SBM frequency, straining, and stool consistency. Clinical development of AMITIZA with a sprinkle formulation and phase three trials in adults and children six months to less than six years of age using the sprinkle formulation will continue as planned.
- Increased adjusted 2016 guidance as follows: revenue guidance to $220-225 million, adjusted net income guidance to $50-55 million, adjusted EPS guidance to $1.20-1.25, and adjusted EBITDA guidance to $110-115 million.
For the three months ended September 30, 2016, Sucampo reported year-over-year total revenue growth of 73% to $57.9 million. Product sales revenue increased to $31.6 million, representing 186% year-over-year growth, and product royalty revenue grew 7% year-over-year to $20.8 million. Revenue for the quarter included an additional $13.3 million because of the R-Tech Ueno acquisition. Excluding this additional revenue from the acquisition, base revenue grew by 33%.Sucampo reported a GAAP net income of $8.1 million, or $0.19 per diluted share during the third quarter of 2016 compared to GAAP net income of $7.2 million, or $0.16 per diluted share, during the third quarter of 2015, an increase of 12% and 19% respectively. On an adjusted basis, Sucampo reported net income of $12.4 million, or $0.28 per diluted share, during the third quarter of 2016, compared to net income of $7.8 million, or $0.17 per diluted shares, during the third quarter of 2015, an increase year-over-year of 58% and 68% respectively. Third Quarter 2016 Operational Review AMITIZA Corporate
- Sucampo Pharmaceuticals, Inc., together with certain of its affiliates and Takeda Pharmaceutical Company Limited (Takeda) and certain of its affiliates, have entered into a settlement and license agreement with Dr. Reddy's and certain of its affiliates that resolves patent litigation in the United States related to AMITIZA 8 mcg and 24 mcg soft gelatin capsules.Under the terms of the settlement and license agreement, Sucampo is granting Dr. Reddy's a non-exclusive license to market a generic version of lubiprostone in the United States beginning more than six years from today's date, or earlier under certain circumstances. Dr. Reddy's would pay to Sucampo a share of net profits of generic lubiprostone products sold during the term of the agreement, which decreases over time and ends when all of the related patents have expired. Dr. Reddy's may elect to purchase generic lubiprostone products from Sucampo under the terms of a manufacturing and supply agreement at a negotiated price.Sucampo, Takeda and Dr. Reddy's have agreed to dismiss with prejudice the patent litigation filed in the U.S. District Court for the Southern District of New Jersey.
- AMITIZA total prescriptions were 374,194 in the third quarter of 2016, as reported by IMS, a decrease of 1.4% compared to the third quarter of 2015. For the first nine months of 2016, AMITIZA total prescriptions were 1,103,778, an increase of 2% compared to the first nine months of 2015. Net sales of AMITIZA, reported by Takeda Pharmaceuticals U.S.A., Inc. (Takeda) for royalty calculation purposes, increased 7% to $108.8 million for the third quarter of 2016, compared to $101.7 million in the same period of 2015. Royalty revenue was $20.8 million compared to $19.3 million, an increase of 7%. Also included in third quarter revenue are Takeda AMITIZA sales from R-Tech Ueno of $10.9 million.
- In Japan, Sucampo's revenue from sales of AMITIZA to Mylan N.V. was $17.4 million for the third quarter of 2016, compared to $10.3 million in the same period of 2015, an increase of 69%. Unit volume as reported by Mylan grew more than 40% through the first nine months of 2016 compared to the first nine months of 2015, to 89.3 million units versus 62 million units in 2015.
- A phase 3 trial of AMITIZA in pediatric functional constipation in children six to seventeen years of age did not achieve its primary endpoint of overall spontaneous bowel movement (SBM) response. However, the trial did show a trend in favor of lubiprostone for the primary endpoint, and achieved statistical significance in some secondary endpoints, notably overall SBM frequency, straining, and stool consistency. In this study, tolerability of lubiprostone was consistent with the safety profile in adults. Sucampo will first review these results with the U.S. Food and Drug Administration and then will announce next steps at the completion of this review. Sucampo intends to initiate enrollment in its clinical development program of the sprinkle formulation of AMITZA in adults by the end of 2016 as planned. After completion of this sprinkle formulation program in adults, a further consultation with the FDA so as to better determine the doses and endpoints that should be studied in the younger pediatric population will follow, aiming at initiation of a phase three program in children 6 months to six years of age using the sprinkle formulation in mid 2017.
- Following a detailed review of the program, Sucampo has made the decision to discontinue development of RTU-1096, a compound in its vascular adhesion protein (VAP-1) inhibitor program.
- On a GAAP basis, Sucampo reported net income of $8.1 million and a diluted EPS of $0.19 during the third quarter of 2016, compared to net income of $7.2 million and diluted EPS of $0.16 in the same period in 2015. Adjusted net income was $12.4 million, or $0.28 per diluted share, during the third quarter of 2016, compared to net income of $7.8 million, or $0.17 per diluted share.
- EBITDA was $35.6 million for the third quarter of 2016 compared to EBITDA of $11.9 million for the same period in 2015, an increase of 196%. Adjusted EBITDA, defined as net income before interest, taxes, depreciation, amortization, stock-based compensation expense, restructuring and intangible impairment, was $28.8 million for the third quarter of 2016 compared to $14.6 million in the same period in 2015, an increase of 97%.
- Total revenues were $57.9 million for the third quarter of 2016 compared to $33.4 million in the same period in 2015, an increase of $24.4 million or 73%. The increase was primarily due to the inclusion of R-Tech Ueno results and increased royalty related revenues from Takeda.
- Cost of goods sold were $15.6 million for the third quarter of 2016 compared to $5.3 million for the same period in 2015, an increase of $10.3 million or 195%. The increase was primarily due to the inclusion of R-Tech Ueno results, acquired intangible asset amortization and increased product sales. Excluding intangible asset amortization of $6.7 million, cost of goods sold was $8.9 million.
- Gross margin, calculated as product sales revenue less cost of goods sold as a percentage of product sales revenue, was 50.6% for the third quarter of 2016, compared to 52.0% for the same period in 2015, a decrease of 3%. The decrease was primarily due to intangible asset amortization. Excluding the intangible asset amortization, gross margin was 71.8%, an increase of 38%. This increase is due to the inclusion of R-Tech Ueno results and the realization of the economics resulting from the acquisition.
- Research and development expenses were $10.0 million for the third quarter of 2016 compared to $8.4 million for the same period of 2015, an increase of $1.6 million or 19%. The increase was primarily due to increased spending on lubiprostone pediatric studies, as well as the inclusion of R-Tech Ueno.
- In connection with the discountinuation of the VAP-1 Inhibitor development program, the Company has impaired the related in process research and development assets and recognized a one time non-cash write-down of $7.3 million in the third quarter of 2016, compared to $0.0 for the prior year period. The Company has adjusted for this one time charge in the results from operations.
- General and administrative expenses were $11.1 million for the third quarter of 2016 compared to $7.8 million for the same period of 2015, an increase of $3.3 million or 42%. The increase was primarily due to legal costs associated with the Dr. Reddy's settlement, RTU intregration costs, restructuring related costs and the inclusion of RTU.
- Selling and marketing expenses were $0.7 million for the third quarter of 2016 compared to $0.4 million for the same period of 2015. Fluctuation was due to the inclusion on R-Tech Ueno related commercial activities.
- Included in other income during the quarter is a one-time gain of $9.3 million related to the termination of a loan from the Japan Agency for Medical Research & Development (AMED) for development of unoprostone, which was discontinued in early 2015.
- The effective tax rate for the third quarter of 2016 was 47.8%, compared to 37.5% in the same period of 2015. The increase in the tax rate is primarily due to the treatment of non-U.S. income.
|Consolidated Statements of Operations and Comprehensive Income (unaudited)|
|(in thousands, except per share data)||Three months ended September 30,|
|Adjusted Non-GAAP Income|
|GAAP net income||8,092||7,205|
|Acquisition Related Expenses||605||943|
|Amortization of Financing Costs||875||-|
|Tax Effect of Adjustments||(2,107||)||(313||)|
|Adjusted Net Income||12,371||7,835|
|Adjusted Net Income Per Share:|
|GAAP net income||8,092||7,236|
|Income Tax Provision||7,410||4,327|
|Amortization of Acquired Intangibles||6,672||-|
|Share Based Compensation Expense||1,722||1,718|
|Acquisition Related Expenses||605||943|
- At September 30, 2016, cash, cash equivalents, restricted cash and investments were $153.7 million compared to $163.5 million at December 31, 2015. This change is primarily due to payments of the outstanding notes and related interest, offset by an increase in cash flow from operating activities. At September 30, 2016 and December 31, 2015, notes payable were $218.7 million and $252.4 million, respectively, including current portions of $21.7 million and $39.1 million, respectively. The change in the overall note payable balance is due to debt repayments made during 2016. Sucampo's net debt position at September 30, 2016 is $65 million, compared to $88.9 million at December 31, 2015.
- Company revenues by product type and geographic location for the three months ended September 30, 2016 and 2015 were as follows
|Three months ended September 30, 2016||Three months ended September 30, 2015|
|(In thousands)||USA||Japan||Rest of theWorld||Total||USA||Japan||Rest of theWorld||Total|
|AMITIZA Product sales||10,919||17,422||792||29,133||-||10,286||-||10,286|
|Rescula Product Sales||21||2,400||-||2,421||736||-||-||736|
See the table below for a comparison of the Company's previous 2016 guidance to the updated 2016 guidance:
|Measure||Previous 2016 Guidance||Updated 2016 Guidance|
|Total Revenue||$195.0 million to $205.0 million||$220.0 million to $225.0 million|
|Adjusted Net Income||$45.0 million to $50.0 million||$50.0 million to $55.0 million|
|Adjusted EPS||$0.97 to $1.07||$1.20 to $1.25|
|Adjusted EBITDA||$100.0 million to $105.0 million||$110.0 million to $115.0 million|
Adjusted EBITDA provides us with an understanding of one aspect of earnings before the impact of investing and financing charges, income taxes and special items. Adjusted EBITDA may be useful to an investor in evaluating our operating performance and liquidity because this measure is widely used by investors to measure a company's operating performance without regard to items excluded from the calculation of such measure, which can vary substantially from company to company. In addition, this is a financial measure that is used by rating agencies, lenders and other parties to evaluate credit worthiness. Finally, this measure is used by management for various purposes, including as a measure of performance of our operating entities and as a basis for strategic planning and forecasting.Management of the company does not consider non-GAAP measures in isolation or as an alternative to financial measures determined in accordance with GAAP. The principal limitation of non-GAAP financial measures is that they exclude significant expenses that are required by GAAP to be recorded in the Sucampo's financial statements. In order to compensate for these limitations, management presents non-GAAP financial measures together with GAAP results. Non-GAAP measures should be considered in addition to results and guidance prepared in accordance with GAAP, but should not be considered a substitute for, or superior to, GAAP results. Reconciliation tables of the most comparable GAAP financial measure to the non-GAAP financial measure used in this press release are included with the financial tables at the end of this release. Sucampo urges investors to review the reconciliation and not to rely on any single financial measure to evaluate the Sucampo's business. In addition, other companies, including companies in our industry, may calculate similarly named non-GAAP measures differently than we do, which limits their usefulness in comparing our financial results with theirs. Company to Host Conference Call Today Sucampo will host a conference call and webcast today, Wednesday, November 9, 2016 at 8:30 am ET.Conference call and Webcast participation details are as follows:Dial-in number: 888-636-8238 (domestic) or 484-747-6635 (international)Passcode: 94640075Webcast link: http://www.sucampo.com/investors/events-presentations/ Conference call replay:Dates: Starting at 11:30 AM ET, November 9, 2016 a replay of the teleconference and webcast will be available Dial-in number: 855-859-2056 (domestic) or 404-537-3406 (international)Passcode: 94640075Webcast link: http://www.sucampo.com/investors/events-presentations/; then click 'Archived Events' About AMITIZA ® (lubiprostone) AMITIZA (lubiprostone) is a chloride channel activator that acts locally in the small intestine. By increasing intestinal fluid secretion, lubiprostone increases motility in the intestine, thereby facilitating the passage of stool and alleviating symptoms associated with CIC. Lubiprostone, via activation of apical CIC-2 channels in intestinal epithelial cells, bypasses the antisecretory action of opiates that results from suppression of secretomotor neuron excitability. Activation of CIC-2 by lubiprostone has also been shown to stimulate recovery of mucosal barrier function and reduce intestinal permeability via the restoration of tight junction protein complexes in ex vivo studies of ischemic porcine intestine.
AMITIZA (24 mcg twice daily) is indicated in the U.S. and Israel for the treatment of adults with CIC and opioid-induced constipation (OIC) with chronic, non-cancer pain. AMITIZA (8 mcg twice daily) is also approved in the U.S. and Israel for irritable bowel syndrome with constipation (IBS-C) in women 18 years of age and older. In Japan, AMITIZA (24 mcg twice daily) is indicated for the treatment of chronic constipation (excluding constipation caused by organic diseases). In Canada, AMITIZA (24 mcg twice daily) is indicated for the treatment of CIC in adults. In the U.K., AMITIZA (24 mcg twice daily) is indicated for the treatment of CIC and associated symptoms in adults, when response to diet and other non-pharmacological measures (e.g. educational measures, physical activity) are inappropriate. In Switzerland, AMITIZA (24 mcg twice daily) is indicated for the treatment of CIC in adults and for the treatment of OIC and associated signs and symptoms such as stool consistency, straining, constipation severity, abdominal discomfort, and abdominal bloating in adults with chronic, non-cancer pain. The efficacy of AMITIZA for the treatment of OIC in patients taking opioids of the diphenylheptane class, such as methadone, has not been established.About RESCULA® Unoprostone isopropyl 0.12% (trade named RESCULA) first received marketing authorization in 1994 in Japan for the treatment of glaucoma and ocular hypertension. RESCULA is marketed in Japan by Santen Pharmaceutical Co., Ltd. (Santen). We acquired RESCULA as part of the acquisition of R-Tech Ueno in 2015. About Sucampo Pharmaceuticals, Inc. Sucampo Pharmaceuticals, Inc. is focused on the development and commercialization of medicines that meet major unmet medical needs of patients worldwide. Sucampo has two marketed products - AMITIZA, its lead product, and RESCULA. A global company, Sucampo is headquartered in Rockville, Maryland, and has operations in Japan, Switzerland and the U.K. 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.
Follow us on Twitter (@Sucampo_Pharma). Follow us on LinkedIn (Sucampo Pharmaceuticals).Twitter LinkedIn 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 financial results, product development, 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 effects of competitive products on Sucampo's products; 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 press release 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 filed with the Securities and Exchange Commission on March 11, 2016, as amended, as well as its filings with the Securities and Exchange Commission on Forms 8-K and 10-Q since the filing of the Form 10-K, all of which Sucampo incorporates by reference.
|Sucampo Pharmaceuticals, Inc.|
|Consolidated Statements of Operations and Comprehensive Income (unaudited)|
|(in thousands, except per share data)|
|Three Months Ended September 30,||Nine Months Ended September 30,|
|Product royalty revenue||$||20,771||$||19,328||$||56,222||$||51,209|
|Product sales revenue||31,554||11,022||86,538||36,678|
|Research and development revenue||3,172||2,714||9,971||7,468|
|Contract and collaboration revenue||2,376||384||4,301||2,457|
|Costs and expenses:|
|Costs of goods sold||15,586||5,286||59,278||18,656|
|Research and development||9,976||8,368||35,580||22,285|
|Impairment of in-process research and development||7,286||-||7,286||-|
|General and administrative||11,061||7,752||32,411||22,363|
|Selling and marketing||696||385||2,094||1,617|
|Total costs and expenses||44,605||21,791||136,649||64,921|
|Income from operations||13,268||11,657||20,383||32,891|
|Non-operating income (expense):|
|Other income, net||8,102||87||5,216||1,947|
|Total non-operating income (expense), net||2,234||(94||)||(12,858||)||1,318|
|Income before income taxes||15,502||11,563||7,525||34,209|
|Income tax provision||(7,410||)||(4,327||)||(4,321||)||(10,989||)|
|Net income per share:|
|Weighted average common shares outstanding:|
|Other comprehensive income (expense):|
|Unrealized gain on pension benefit obligation||12||57||37||38|
|Unrealized gain (loss) on investments, net of tax effect||-||(6||)||-||6|
|Foreign currency translation gain||4,635||264||40,890||102|
|Sucampo Pharmaceuticals, Inc.|
|Consolidated Balance Sheets (unaudited)|
|(in thousands, except share and per share data)|
|September 30,||December 31,|
|Cash and cash equivalents||$||128,465||$||108,284|
|Product royalties receivable||20,771||22,792|
|Accounts receivable, net||20,684||22,759|
|Prepaid expenses and other current assets||18,146||9,186|
|Total current assets||237,481||251,360|
|Property and equipment, net||6,563||6,393|
|In-process research and development||-||6,171|
|Deferred charge, non-current||1,400||1,400|
|Convertible note receivable||5,182||-|
|LIABILITIES AND STOCKHOLDERS' EQUITY|
|Income tax payable||16,587||6,507|
|Notes payable, current||21,730||39,083|
|Other current liabilities||4,805||14,815|
|Total current liabilities||66,809||88,127|
|Notes payable, non-current||196,984||213,277|
|Deferred revenue, non-current||913||1,088|
|Deferred tax liability, net||41,757||52,497|
|Preferred stock, $0.01 par value; 5,000,000 shares authorized at September 30, 2016 and December 31, 2015; no shares issued and outstanding at September 30, 2016 and December 31, 2015||-||-|
|Class A common stock, $0.01 par value; 270,000,000 shares authorized at September 30, 2016 and December 31, 2015; 45,828,775 and 45,509,150 shares issued and outstanding at September 30, 2016 and December 31, 2015, respectively||458||455|
|Class B common stock, $0.01 par value; 75,000,000 shares authorized at September 30, 2016 and December 31, 2015; no shares issued and outstanding at September 30, 2016 and December 31, 2015||-||-|
|Additional paid-in capital||113,440||99,212|
|Accumulated other comprehensive income||54,339||13,412|
|Treasury stock, at cost; 3,009,942 shares at September 30, 2016 and December 31, 2015||(46,269||)||(46,269||)|
|Total stockholders' equity||144,810||86,449|
|Total liabilities and stockholders' equity||$||459,564||$||457,181|
Contact:Sucampo Pharmaceuticals, Inc.Silvia TaylorSenior Vice President, Investor Relations and Corporate Affairs1firstname.lastname@example.org