Sucampo Pharmaceuticals, Inc.
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(Exact Name of Registrant as Specified in Charter) |
Delaware
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001-33609
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30-0520478
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(State or Other Juris-
diction of Incorporation)
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(Commission
File Number)
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(IRS Employer
Identification No.)
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4520 East-West Highway, 3rd Floor
Bethesda, Maryland
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20814
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(Address of Principal Executive Offices)
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(Zip Code)
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(Former Name or Former Address, if Changed Since Last Report)
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(d) | Exhibits | |
The following exhibit relating to Item 2.02 shall be deemed to be furnished, and not filed:
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99.1 | Press Release issued by the Company on August 5, 2014. | |
99.2 | The corporate update presentation slides dated August 5, 2014. | |
SUCAMPO PHARMACEUTICALS, INC. | ||||
Date: August 5, 2014
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By: |
/s/Thomas J. Knapp
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Name: Thomas J. Knapp | ||||
Title: EVP, Chief Legal Officer and Corporate Secretary
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EXHIBIT 99.1
Positive Net Income Driven by Strong Revenue Growth in Product Royalty and Product Sales
CEO Peter Greenleaf to Discuss Results of Sucampo's Strategic Review
Company Raises Full Year 2014 Earnings Guidance
Company to host conference call today at 8:30 am Eastern
BETHESDA, Md., Aug. 5, 2014 (GLOBE NEWSWIRE) -- Sucampo Pharmaceuticals, Inc. (Sucampo) (Nasdaq:SCMP) today reported consolidated financial results for the second quarter and six months ended June 30, 2014. Sucampo reported year over year growth of 16% to $13.9 million in product royalty revenue and 122% to $7.5 million in product sales, net income of $1.6 million and fully-diluted earnings per share of $0.04 during the second quarter of 2014.
"In the second quarter, Sucampo continued to make excellent progress driven by our strong financial performance. AMITIZA royalty revenue in the U.S. and product sales revenue in Japan grew impressively, and in Europe we made important strides in increasing access to AMITIZA for the U.K. and Swiss markets. In addition, we continued to make significant progress against our 2014 objectives as well as in planning for Sucampo's continued evolution, advancing our clinical development programs, focusing our resources on value-enhancing activities, and strengthening our management team," said Peter Greenleaf, Chief Executive Officer of Sucampo. "During this morning's call, I look forward to sharing the results of our strategic review and my views of how we will focus Sucampo on our core capabilities of scientific innovation to accelerate patient, healthcare provider, and shareholder value."
Second Quarter 2014 Operational Review
AMITIZA
RESCULA
Research and Development
Corporate
Second Quarter 2014 Financial Review
Cash, Cash Equivalents, Restricted Cash and Marketable Securities
At June 30, 2014, cash, cash equivalents, restricted cash and investments were $103.6 million compared to $95.9 million at December 31, 2013. At June 30, 2014, notes payable were $49.5 million, compared to $52.7 million at December 31, 2013, including current notes payable of $27.8 million at June 30, 2014 and $26.9 million at December 31, 2013.
Guidance
Sucampo today increased its earnings guidance for 2014. Sucampo now expects full year 2014 GAAP net income to be in the range of $4.0 million to $6.0 million, or $0.08 to $0.13 per diluted share.
Company to Host Conference Call Today
Sucampo will host a conference call and webcast today at 8:30 am Eastern. To participate on the live call, please dial 877-703-6104 (domestic) or 857-244-7303 (international), and provide the participant passcode 29794935, 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), passcode 95005218. 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 in the United States for the treatment of CIC in adults and OIC in adults with chronic, non-cancer pain (24 mcg twice daily). The effectiveness in patients with OIC taking diphenylheptane opioids (e.g., methadone) has not been established. AMITIZA is also indicated in the U.S. for irritable bowel syndrome with constipation (8 mcg twice daily) in women 18 years of age and older in the U.S. In Japan, AMITIZA (24 mcg twice daily) is indicated for the treatment of chronic constipation (excluding constipation caused by organic diseases). 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 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 unoprostone isopropyl ophthalmic solution) 0.15% 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 medicines to meet the major unmet medical needs of patients on a global basis. Sucampo has two marketed products – AMITIZA and RESCULA – and a pipeline of product candidates in clinical development. A global company, Sucampo is headquartered in Bethesda, Maryland, and has operations in Japan, Switzerland and the U.K. For more information, please visit www.sucampo.com.
The Sucampo logo is the registered trademark and the tagline, The Science of Innovation, is a pending trademark 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.
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 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; the ability of Sucampo to develop and commercialize existing and pipeline products; 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; 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 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 filed with the Securities and Exchange Commission on March 12, 2014 as well as its filings with the Securities and Exchange Commission on Form 10-Q and 8-K, 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 June 30, | Six Months Ended June 30, | |||
2014 | 2013 | 2014 | 2013 | |
Revenues: | ||||
Research and development revenue | $ 1,700 | $ 11,461 | $ 3,484 | $ 14,261 |
Product royalty revenue | 13,888 | 12,000 | 27,389 | 23,677 |
Product sales revenue | 7,543 | 3,399 | 13,855 | 5,616 |
Co-promotion revenue | 723 | -- | 1,085 | 61 |
Contract and collaboration revenue | 215 | 163 | 417 | 327 |
Total revenues | 24,069 | 27,023 | 46,230 | 43,942 |
Costs and expenses: | ||||
Cost of goods sold | 3,796 | 1,908 | 7,189 | 3,190 |
Research and development | 4,252 | 4,425 | 9,387 | 10,054 |
General and administrative | 8,197 | 5,968 | 15,454 | 13,195 |
Selling and marketing | 4,013 | 4,553 | 7,660 | 9,942 |
Total costs and expenses | 20,258 | 16,854 | 39,690 | 36,381 |
Income from operations | 3,811 | 10,169 | 6,540 | 7,561 |
Non-operating income (expense): | ||||
Interest income | 23 | 23 | 80 | 42 |
Interest expense | (392) | (493) | (792) | (988) |
Other income (expense), net | (53) | 870 | (376) | 2,020 |
Total non-operating income (expense), net | (422) | 400 | (1,088) | 1,074 |
Income before income taxes | 3,389 | 10,569 | 5,452 | 8,635 |
Income tax provision | (1,779) | (4,324) | (3,086) | (5,466) |
Net income | $ 1,610 | $ 6,245 | $ 2,366 | $ 3,169 |
Net income per share: | ||||
Basic | $0.04 | $0.15 | $0.05 | $0.08 |
Diluted | $0.04 | $0.15 | $0.05 | $0.07 |
Weighted average common shares outstanding: | ||||
Basic | 43,640 | 41,604 | 43,521 | 41,533 |
Diluted | 43,640 | 42,868 | 43,609 | 42,597 |
Comprehensive income: | ||||
Net income | $ 1,610 | $ 6,245 | $ 2,366 | $ 3,169 |
Other comprehensive income (loss): | ||||
Unrealized loss on investments, net of tax effect | (3) | (19) | 5 | (34) |
Foreign currency translation | (126) | (186) | (245) | (134) |
Comprehensive income | $ 1,481 | $ 6,040 | $ 2,126 | $ 3,001 |
Sucampo Pharmaceuticals, Inc. | ||
Consolidated Balance Sheets (unaudited) | ||
(in thousands, except share data) | ||
June 30, | December 31, | |
2014 | 2013 | |
ASSETS: | ||
Current assets: | ||
Cash and cash equivalents | $ 53,532 | $ 44,102 |
Investments, current | 14,017 | 16,003 |
Product royalties receivable | 13,888 | 14,829 |
Unbilled accounts receivable | 3 | 1 |
Accounts receivable, net | 4,755 | 5,407 |
Prepaid and income taxes receivable | 545 | 9 |
Deferred tax assets, current | 1,988 | 2,028 |
Deferred charge, current | 673 | 673 |
Restricted cash, current | 26,129 | 26,115 |
Inventory | 423 | 209 |
Prepaid expenses and other current assets | 3,396 | 3,977 |
Total current assets | 119,349 | 113,353 |
Investments, non-current | 7,460 | 7,219 |
Property and equipment, net | 979 | 1,156 |
Intangibles assets, net | 5,949 | 6,438 |
Deferred tax assets, non-current | 1,275 | 1,212 |
Deferred charge, non-current | 4,204 | 4,540 |
Restricted cash, non-current | 2,471 | 2,471 |
Other assets | 552 | 488 |
Total assets | $ 142,239 | $ 136,877 |
LIABILITIES AND STOCKHOLDERS' EQUITY: | ||
Current liabilities: | ||
Accounts payable | $ 5,623 | $ 7,614 |
Accrued expenses | 6,264 | 5,682 |
Deferred revenue, current | 1,794 | 1,365 |
Income tax payable | 35 | 701 |
Notes payable, current | 27,790 | 26,892 |
Other current liabilities | 1,013 | 358 |
Total current liabilities | 42,519 | 42,612 |
Notes payable, non-current | 21,741 | 25,828 |
Deferred revenue, non-current | 5,824 | 6,169 |
Deferred tax liability, non-current | 1,223 | 2,066 |
Other liabilities | 1,559 | 1,233 |
Total liabilities | 72,866 | 77,908 |
Stockholders' equity: | ||
Preferred stock, $0.01 par value; 5,000,000 shares authorized at June 30, 2014 and December 31, 2013; no shares issued and outstanding at June 30, 2014 and December 31, 2013 | -- | -- |
Class A common stock, $0.01 par value; 270,000,000 shares authorized at June 30, 2014 and December 31, 2013; 44,293,899 and 43,315,749 shares issued and outstanding at June 30, 2014 and December 31, 2013, respectively | ||
Class B common stock, $0.01 par value; 75,000,000 shares authorized at June 30, 2014 and December 31, 2013; no shares issued and outstanding at June 30, 2014 and December 31, 2013 | -- | -- |
Additional paid-in capital | 80,377 | 72,109 |
Accumulated other comprehensive income | 15,361 | 15,601 |
Treasury stock, at cost; 524,792 and 524,792 shares | (2,313) | (2,313) |
Accumulated deficit | (24,494) | (26,860) |
Total stockholders' equity | 69,373 | 58,969 |
Total liabilities and stockholders' equity | $ 142,239 | $ 136,877 |
Sucampo Pharmaceuticals, Inc. | ||||
Key Segment Information (unaudited) | ||||
(In thousands) | Americas | Europe | Asia | Consolidated |
Three Months Ended June 30, 2014 | ||||
Research and development revenue | $ 1,700 | $ -- | $ -- | $ 1,700 |
Product royalty revenue | 13,888 | -- | -- | 13,888 |
Product sales revenue | 223 | 99 | 7,221 | 7,543 |
Co-promotion revenue | 723 | -- | -- | 723 |
Contract and collaboration revenue | 141 | 64 | 10 | 215 |
Total revenues | 16,675 | 163 | 7,231 | 24,069 |
Costs of goods sold | 146 | 14 | 3,636 | 3,796 |
Research and development expenses | 2,243 | 1,223 | 786 | 4,252 |
Depreciation and amortization | 186 | 166 | 8 | 360 |
Other operating expenses | 8,839 | 2,500 | 511 | 11,850 |
Income (loss) from operations | 5,261 | (3,740) | 2,290 | 3,811 |
Interest income | 22 | 1 | -- | 23 |
Interest expense | (352) | -- | (40) | (392) |
Other non-operating expense, net | 5 | 942 | (1,000) | (53) |
Income (loss) before income taxes | $ 4,936 | $ (2,797) | $ 1,250 | $ 3,389 |
Capital expenditures | $ 4 | $ 2 | $ 2 | $ 8 |
Three Months Ended June 30, 2013 | ||||
Research and development revenue | $ 11,461 | $ -- | $ -- | $ 11,461 |
Product royalty revenue | 12,000 | -- | -- | 12,000 |
Product sales revenue | 106 | 12 | 3,281 | 3,399 |
Co-promotion revenue | -- | -- | -- | -- |
Contract and collaboration revenue | 142 | 10 | 11 | 163 |
Total revenues | 23,709 | 22 | 3,292 | 27,023 |
Costs of goods sold | 53 | 3 | 1,852 | 1,908 |
Research and development expenses | 1,304 | 1,941 | 1,180 | 4,425 |
Depreciation and amortization | 112 | 251 | 9 | 372 |
Other operating expenses | 8,159 | 1,130 | 860 | 10,149 |
Income (loss) from operations | 14,081 | (3,303) | (609) | 10,169 |
Interest income | 20 | 2 | 1 | 23 |
Interest expense | -- | (449) | (44) | (493) |
Other non-operating expense, net | 1 | (72) | 941 | 870 |
Income (loss) before income taxes | $ 14,102 | $ (3,822) | $ 289 | $ 10,569 |
Capital expenditures | $ 17 | $ 3 | $ -- | $ 20 |
Six Months Ended June 30, 2014 | ||||
Research and development revenue | $ 3,484 | $ -- | $ -- | $ 3,484 |
Product royalty revenue | 27,389 | -- | -- | 27,389 |
Product sales revenue | 381 | 155 | 13,319 | 13,855 |
Co-promotion revenue | 1,085 | -- | -- | 1,085 |
Contract and collaboration revenue | 283 | 114 | 20 | 417 |
Total revenues | 32,622 | 269 | 13,339 | 46,230 |
Costs of goods sold | 296 | 39 | 6,854 | 7,189 |
Research and development expenses | 4,832 | 2,635 | 1,920 | 9,387 |
Depreciation and amortization | 374 | 332 | 15 | 721 |
Other operating expenses | 16,680 | 4,734 | 979 | 22,393 |
Income (loss) from operations | 10,440 | (7,471) | 3,571 | 6,540 |
Interest income | 43 | 4 | 33 | 80 |
Interest expense | (711) | -- | (81) | (792) |
Other non-operating expense, net | 2 | 990 | (1,368) | (376) |
Income (loss) before income taxes | $ 9,774 | $ (6,477) | $ 2,155 | $ 5,452 |
Capital expenditures | $ 45 | $ 2 | $ 2 | $ 49 |
Six Months Ended June 30, 2013 | ||||
Research and development revenue | $ 14,261 | $ -- | $ -- | $ 14,261 |
Product royalty revenue | 23,677 | -- | -- | 23,677 |
Product sales revenue | 107 | 20 | 5,489 | 5,616 |
Co-promotion revenue | 61 | -- | -- | 61 |
Contract and collaboration revenue | 283 | 22 | 22 | 327 |
Total revenues | 38,389 | 42 | 5,511 | 43,942 |
Costs of goods sold | 76 | 8 | 3,106 | 3,190 |
Research and development expenses | 2,586 | 4,612 | 2,856 | 10,054 |
Depreciation and amortization | 234 | 501 | 18 | 753 |
Other operating expenses | 18,476 | 1,728 | 2,180 | 22,384 |
Income (loss) from operations | 17,017 | (6,807) | (2,649) | 7,561 |
Interest income | 35 | 6 | 1 | 42 |
Interest expense | -- | (909) | (79) | (988) |
Other non-operating expense, net | (15) | (264) | 2,299 | 2,020 |
Income (loss) before income taxes | $ 17,037 | $ (7,974) | $ (428) | $ 8,635 |
Capital expenditures | $ 31 | $ 106 | $ 3 | $ 140 |
CONTACT: Sucampo Pharmaceuticals, Inc. Silvia Taylor Senior Vice President, Investor Relations and Corporate Communications 1-240-223-3718 staylor@sucampo.com