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Sucampo Reports Third Quarter 2016 Financial Results

November 9, 2016 6:30 AM

Results Driven by 73% Growth in Revenue

GAAP EPS Growth of 12%; Adjusted EPS Growth of 58%

Company Raises 2016 Guidance and Provides Preliminary 2017 Guidance

Announces Settlement with Dr. Reddy’s Laboratories for AMITIZA

Reports Phase Three Results for AMITIZA in Pediatric Population

Company to Host Conference Call Today at 8:30 a.m. EST

ROCKVILLE, Md., Nov. 09, 2016 (GLOBE NEWSWIRE) -- Sucampo Pharmaceuticals, Inc. (Sucampo) (NASDAQ: SCMP), a global biopharmaceutical company, today reported consolidated financial results for the third quarter ended September 30, 2016. The company also highlighted important corporate updates.

Summary of ResultsQ3-16% Increase / (Decrease)over Q3-15
Revenue$57.9M 73%
Net Income GAAP$8.1M 12%
EPS GAAP – diluted$0.19 19%
EBITDA$35.6M 197%
Adjusted Net Income$12.4M 58%
Adjusted EPS – diluted$0.28 68%
Adjusted EBITDA$28.8M 97%

Key Updates

“We are very excited that we have achieved another significant quarter of strong financial results, driven by solid global performance of our flagship brand, AMITIZA. Additionally, we continued to make significant progress on many important areas of our business, including the resolution of our patent litigation with Dr. Reddy’s Laboratories that affords us greater certainty on the significant future value of the AMITIZA franchise, ” said Peter Greenleaf, Chairman and Chief Executive Officer of Sucampo. “Looking forward to the remainder of 2016 and throughout 2017, we will be focused on the execution of our base business, next steps in our phase three program for AMITIZA in pediatric functional constipation and development of a sprinkle formulation, and completion of strategic transactions to further boost growth and diversify our company.”

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

United States

Global Markets

Research and Development

Third Quarter 2016 Financial Review

Certain prior year non-GAAP amounts have been reclassified for consistency with the current period- adjusted presentation. These reclassifications had no effect on the reported results of operations. A reconciliation of adjusted Net Income to GAAP Net Income and adjusted EBITDA to net income, the most directly comparable GAAP financial measure, is included in the tables below.

Consolidated Statements of Operations and Comprehensive Income (unaudited)
(in thousands, except per share data)Three months ended September 30,
2016 2015
Adjusted Non-GAAP Income
GAAP net income 8,092 7,205
Amortization Intangibles 6,672 -
Intangible Impairment 7,286 -
Legal Settlement (9,260) -
Restructuring Costs 208 -
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:
Diluted$0.28 $0.17
2016 2015
EBITDA
GAAP net income 8,092 7,236
Income Tax Provision 7,410 4,327
Interest income (31) (30)
Interest payable 5,899 243
Depreciation 223 201
Amortization of Acquired Intangibles 6,672 -
Intangible Impairment 7,286 -
EBITDA 35,551 11,977
Non-GAAP Adjustments
Share Based Compensation Expense 1,722 1,718
Restructuring Costs 208 -
Acquisition Related Expenses 605 943
Legal settlement (9,260) -
Adjusted EBITDA 28,826 14,638

Cash, Cash Equivalents, Restricted Cash and Marketable Securities

Geographic Sales

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
AMITIZA Royalty 20,770 - - 20,770 19,327 - - 19,327
Rescula Product Sales 21 2,400 - 2,421 736 - - 736
Total 31,710 19,822 792 52,324 20,063 10,286 - 30,349

Guidance

Sucampo today raised its earnings guidance for the full year ending December 31, 2016. Sucampo now expects total revenue of $220.0 million to $225.0 million, adjusted net income of $50.0 million to $55.0 million, adjusted EPS of $1.20 to $1.25, and adjusted EBITDA of $110.0 million to $115.0 million. Adjusted net income guidance excludes amortization of acquired intangibles of approximately $17.6 million, restructuring related costs of $1.9 million, debt financing related costs of $3.5 million, CPP option related expenses of $7.5 million, amortization of the remaining inventory step-up costs of approximately $8.9 million, intangible asset impairment expense of $7.3 million and one time gains associated with a legal settlement of $9.3 million. Adjusted EBITDA guidance excludes stock option related expenses of $7.3 million, one time restructuring related costs of $1.9 million and CPP option related expenses of $7.5 million. Guidance includes a one-time $10.0 million milestone in the fourth quarter of 2016 related to the achievement of sales milestone from Mylan related to sales of AMITIZA in Japan.

See the table below for a comparison of the Company's previous 2016 guidance to the updated 2016 guidance:

MeasurePrevious 2016 GuidanceUpdated 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

Sucampo is also providing preliminary earnings guidance for the full year ending December 31, 2017. Sucampo expects total revenue of $220.0 million to $230.0 million, adjusted net income of $75.0 million to $85.0 million, and adjusted EBITDA of $145.0 million to $155.0 million. Adjusted net income guidance excludes amortization of acquired intangibles of approximately $22.58 million and debt financing related costs of $3.1 million. Adjusted EBITDA guidance excludes stock option related costs of $6.0 million.

Non-GAAP Financial Measures

This press release contains non-GAAP earnings and adjusted EBITDA as listed in the first table above, which is GAAP net income before interest, tax, depreciation, amortization, stock option expense and intangible impairment. Sucampo believes that this non-GAAP measure of financial results provides useful information to management and investors relating to its results of operations. Sucampo's management uses this non-GAAP measure to compare Sucampo's performance to that of prior periods for trend analyses, and for budgeting and planning purposes, as management believes this provides a more comparable measure of our continuing business, as it adjusts for special items that are not reflective of the normal earnings of our business. Sucampo believes that the use of non-GAAP financial measures provides an additional tool for investors to use in evaluating ongoing operating results and trends and in comparing the Sucampo's financial measures with other companies in its industry, many of which present similar non-GAAP financial measures to investors, and that it allows for greater transparency with respect to key metrics used by management in its financial and operational decision-making.

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).

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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 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,
2016 2015 2016 2015
Revenues:
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
Total revenues 57,873 33,448 157,032 97,812
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):
Interest income 31 62 67 155
Interest expense (5,899) (243) (18,141) (784)
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$ 8,092 $ 7,236 $ 3,203 $ 23,220
Net income per share:
Basic$ 0.19 $ 0.16 $ 0.08 $ 0.52
Diluted$ 0.19 $ 0.16 $ 0.07 $ 0.51
Weighted average common shares outstanding:
Basic 42,813 44,731 42,704 45,576
Diluted 43,443 46,309 43,334 45,939
Comprehensive income
Net income$ 8,092 $ 7,236 $ 3,203 $ 23,220
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
Comprehensive income$ 12,739 $ 7,551 $ 44,130 $ 23,366

Sucampo Pharmaceuticals, Inc.
Consolidated Balance Sheets (unaudited)
(in thousands, except share and per share data)
September 30, December 31,
2016 2015
ASSETS
Current assets:
Cash and cash equivalents$ 128,465 $ 108,284
Product royalties receivable 20,771 22,792
Accounts receivable, net 20,684 22,759
Restricted cash 25,213 55,218
Inventories 24,202 33,121
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
Intangible assets 134,886 130,315
Goodwill 73,022 60,937
In-process research and development - 6,171
Deferred charge, non-current 1,400 1,400
Convertible note receivable 5,182 -
Other assets 1,030 605
Total assets$ 459,564 $ 457,181
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable$ 7,869 $ 11,213
Accrued expenses 14,380 10,886
Collaboration obligation 1,438 5,623
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
Other liabilities 8,291 15,743
Total liabilities 314,754 370,732
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, $0.01 par value; 75,000,000 shares authorized at September 30, 2016 and December 31, 2015; no shares issued and outstanding at September 30, 2016 and December 31, 2015 - -
Additional paid-in capital 113,440 99,212
Accumulated other comprehensive income 54,339 13,412
Treasury stock, at cost; 3,009,942 shares at September 30, 2016 and December 31, 2015 (46,269) (46,269)
Retained earnings 22,842 19,639
Total stockholders' equity 144,810 86,449
Total liabilities and stockholders' equity$ 459,564 $ 457,181

Contact:
Sucampo Pharmaceuticals, Inc.
Silvia Taylor
Senior Vice President, Investor Relations and Corporate Affairs
1-240-223-3718
[email protected]

Source: Sucampo Pharmaceuticals Inc

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