Sucampo Pharmaceuticals, Inc.
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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: | ||
99.1 Press Release issued by the Company on November 6, 2014. | ||
99.2 The corporate update presentation slides dated November 6, 2014. |
SUCAMPO PHARMACEUTICALS, INC.
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Date: November 6, 2014 |
By:
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/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
Strong Revenue and Sales Growth for AMITIZA
Raises 2014 Earnings Guidance, Excluding Special Items
CEO Peter Greenleaf to Provide Update on Significant Progress Against Strategic Plan
Sucampo to host conference call today at 8:30 am Eastern
BETHESDA, Md., Nov. 6, 2014 (GLOBE NEWSWIRE) -- Sucampo Pharmaceuticals, Inc. (Sucampo) (Nasdaq:SCMP) today reported consolidated financial results for the third quarter and nine months ended September 30, 2014. Sucampo reported year over year growth of 49% to $31.5 million in total revenue, 24% to $16.8 million in product royalty revenue and 118% to $11.7 million in product sales. Sucampo also reported net income of $1.5 million and fully-diluted earnings per share (EPS) of $0.03 during the third quarter of 2014.
Sucampo raised its full year 2014 earnings guidance to $15.0 million to $20.0 million net income, excluding special items, versus previous guidance of $4.0 million to $6.0 million. During the third quarter of 2014, Sucampo recorded a non-cash impairment to its intangible assets of $5.6 million to reflect a reduction in the expected future cash flows received from the sales of RESCULA for the approved indication, which Sucampo has ceased marketing, and no further orders have been made. Details of the impairment charge are discussed in the Cost of Goods and R&D expenses sections below.
Three Months Ended September 30, |
Nine Months Ended September 30, |
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(In thousands, except per share data) | 2014 | 2014 |
Total revenues | $ 31,463 | $ 77,693 |
GAAP Diluted EPS | 0.03 | 0.09 |
Non-GAAP Diluted EPS that exclude RESCULA intangible non-cash impairment1 | 0.14 | 0.20 |
GAAP net income2 | 1,480 | 3,846 |
Non-GAAP net income that excludes RESCULA intangible non-cash impairment | 6,282 | 8,648 |
1. Sucampo is providing certain 2014 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. |
"In the third quarter, Sucampo's strong financial performance continued, and I am pleased that we made significant progress against our strategy," said Peter Greenleaf, Chief Executive Officer of Sucampo. "Our total revenue grew 49% driven by AMITIZA's continued growth in the US and Japan. The prospects for additional growth of the product are greater than ever given the agreements we signed this quarter: creating a global partnership with Takeda, expanding the current AMITIZA agreement with Takeda for North America, and settling our generic litigation. This is a time of great opportunity for Sucampo, as we continue to execute on our strategy with a focus on the development of our pipeline and the diversification of our science."
Third Quarter 2014 Operational Review
AMITIZA
United States (U.S.)
Global Markets
Research and Development
Corporate
Third Quarter 2014 Financial Review
Earnings Excluding Special Items
Net income excluding special items for the third quarter of 2014 was $6.3 million, or $0.14 per diluted share, compared to a net income of $4.0 million, or $0.09 per diluted share, in the third quarter of 2013. Net income excluding special items for the first nine months of 2014 was $8.6 million, or $0.20 per diluted share, compared to a net income of $7.0 million, or $0.16 per diluted share, in the first nine months of 2013.
Non-GAAP (generally accepted accounting principles) EPS for the third quarter and nine months ended September 30, 2014 of $0.14 and $0.20, respectively, exclude RESCULA intangible impairment.
A reconciliation of GAAP to non-GAAP net income and EPS is provided in the tables that follow.
Three Months Ended September 30, |
Nine Months Ended September 30, |
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(In thousands, except per share data) | 2014 | 2014 |
EPS | ||
GAAP Diluted EPS | $ 0.03 | $ 0.09 |
Difference3 | 0.11 | 0.11 |
Non-GAAP Diluted EPS that exclude RESCULA intangible non-cash impairment1 | 0.14 | 0.20 |
Net income | ||
GAAP net income2 | $ 1,480 | $ 3,846 |
Difference | 4,802 | 4,802 |
Non-GAAP net income that excludes RESCULA intangible non-cash impairment | 6,282 | 8,648 |
Increase in net income due to excluded items: | ||
Net increase in income before taxes | $ (5,631) | $ (5,631) |
Estimated income tax expense | 829 | 829 |
Increase in net income | (4,802) | (4,802) |
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 September 30, 2014, cash, cash equivalents, restricted cash and investments were $106.4 million compared to $95.9 million at December 31, 2013. At September 30, 2014, notes payable were $48.1 million, compared to $52.7 million at December 31, 2013, including current notes payable of $26.3 million at September 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, excluding special items to be in the range of $15.0 million to $20.0 million, or $0.35 to $0.45 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 866-953-6858 (domestic) or 617-399-3482 (international), and provide the participant passcode 19360046, 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 31546071. 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, and is a locally acting chloride channel activator, indicated in the U.S. 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 Japan, AMITIZA (24 mcg twice daily) is indicated for the treatment of chronic constipation (excluding constipation caused by organic diseases). In the United Kingdom (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 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 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 registered/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.
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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 September 30, | Nine Months Ended September 30, | |||
2014 | 2013 | 2014 | 2013 | |
Revenues: | ||||
Research and development revenue | $ 1,797 | $ 2,027 | $ 5,281 | $ 16,288 |
Product royalty revenue | 16,811 | 13,595 | 44,200 | 37,271 |
Product sales revenue | 11,717 | 5,378 | 25,572 | 10,994 |
Co-promotion revenue | 936 | -- | 2,021 | 61 |
Contract and collaboration revenue | 202 | 163 | 619 | 490 |
Total revenues | 31,463 | 21,163 | 77,693 | 65,104 |
Costs and expenses: | ||||
Costs of goods sold | 4,974 | 6,267 | 12,163 | 9,457 |
Intangible assets impairment | 5,631 | -- | 5,631 | -- |
Research and development | 5,297 | 4,474 | 14,684 | 14,528 |
General and administrative | 8,117 | 5,440 | 23,571 | 18,635 |
Selling and marketing | 3,801 | 6,026 | 11,461 | 15,967 |
Total costs and expenses | 27,820 | 22,207 | 67,510 | 58,587 |
Income (loss) from operations | 3,643 | (1,044) | 10,183 | 6,517 |
Non-operating income (expense): | ||||
Interest income | 26 | 20 | 106 | 63 |
Interest expense | (384) | (461) | (1,176) | (1,449) |
Other income (expense), net | 519 | 183 | 143 | 2,203 |
Total non-operating income (expense), net | 161 | (258) | (927) | 817 |
Income (loss) before income taxes | 3,804 | (1,302) | 9,256 | 7,334 |
Income tax (provision) benefit | (2,324) | 2,825 | (5,410) | (2,641) |
Net income | $ 1,480 | $ 1,523 | $ 3,846 | $ 4,693 |
Net income per share: | ||||
Basic | $ 0.03 | $ 0.04 | $ 0.09 | $ 0.11 |
Diluted | $ 0.03 | $ 0.04 | $ 0.09 | $ 0.11 |
Weighted average common shares outstanding: | ||||
Basic | 43,796 | 41,863 | 43,613 | 41,644 |
Diluted | 43,796 | 42,787 | 43,613 | 42,662 |
Comprehensive income: | ||||
Net income | $ 1,480 | $ 1,523 | $ 3,846 | $ 4,693 |
Other comprehensive income (loss): | ||||
Unrealized gain (loss) on investments, net of tax effect | (5) | 18 | -- | (16) |
Foreign currency translation | 287 | (253) | 42 | (387) |
Comprehensive income | $ 1,762 | $ 1,288 | $ 3,888 | $ 4,290 |
Sucampo Pharmaceuticals, Inc. | ||
Consolidated Balance Sheets (unaudited) | ||
(in thousands, except share data) | ||
September 30, | December 31, | |
2014 | 2013 | |
ASSETS | ||
Current assets: | ||
Cash and cash equivalents | $ 56,087 | $ 44,102 |
Investments, current | 8,857 | 16,003 |
Product royalties receivable | 16,811 | 14,829 |
Unbilled accounts receivable | 2 | 1 |
Accounts receivable, net | 8,453 | 5,407 |
Prepaid and income taxes receivable | 3,678 | 9 |
Deferred tax assets, current | -- | 2,028 |
Deferred charge, current | 377 | 673 |
Restricted cash, current | 26,114 | 26,115 |
Inventory | 133 | 209 |
Prepaid expenses and other current assets | 3,550 | 3,977 |
Total current assets | 124,062 | 113,353 |
Investments, non-current | 13,046 | 7,219 |
Property and equipment, net | 882 | 1,156 |
Intangible assets, net | 157 | 6,438 |
Deferred tax assets, non-current | 1,436 | 1,212 |
Deferred charge, non-current | 2,261 | 4,540 |
Restricted cash, non-current | 2,313 | 2,471 |
Other assets | 461 | 488 |
Total assets | $ 144,618 | $ 136,877 |
LIABILITIES AND STOCKHOLDERS' EQUITY | ||
Current liabilities: | ||
Accounts payable | $ 5,924 | $ 7,614 |
Accrued expenses | 7,160 | 5,682 |
Deferred revenue, current | 2,047 | 1,365 |
Income tax payable | -- | 701 |
Notes payable, current | 26,342 | 26,892 |
Other current liabilities | 2,436 | 358 |
Total current liabilities | 43,909 | 42,612 |
Notes payable, non-current | 21,741 | 25,828 |
Deferred revenue, non-current | 5,457 | 6,169 |
Deferred tax liability, non-current | 343 | 2,066 |
Other liabilities | 1,512 | 1,233 |
Total liabilities | 72,962 | 77,908 |
Stockholders' equity: | ||
Preferred stock, $0.01 par value; 5,000,000 shares authorized at September 30, 2014 and December 31, 2013; no shares issued and outstanding at September 30, 2014 and December 31, 2013 | -- | -- |
Class A common stock, $0.01 par value; 270,000,000 shares authorized at September 30, 2014 and December 31, 2013; 44,330,465 and 43,315,749 shares issued and outstanding at September 30, 2014 and December 31, 2013, respectively | 443 | 432 |
Class B common stock, $0.01 par value; 75,000,000 shares authorized at September 30, 2014 and December 31, 2013; no shares issued and outstanding at September 30, 2014 and December 31, 2013 | -- | -- |
Additional paid-in capital | 80,897 | 72,109 |
Accumulated other comprehensive income | 15,643 | 15,601 |
Treasury stock, at cost; 524,792 and 524,792 shares | (2,313) | (2,313) |
Accumulated deficit | (23,014) | (26,860) |
Total stockholders' equity | 71,656 | 58,969 |
Total liabilities and stockholders' equity | $ 144,618 | $ 136,877 |
Sucampo Pharmaceuticals, Inc. | ||||
Key Segment Information (unaudited) | ||||
(In thousands) | Americas | Europe | Asia | Consolidated |
Three Months Ended September 30, 2014 | ||||
Research and development revenue | $ 1,797 | $ -- | $ -- | $ 1,797 |
Product royalty revenue | 16,811 | -- | -- | 16,811 |
Product sales revenue | 170 | 142 | 11,405 | 11,717 |
Co-promotion revenue | 936 | -- | -- | 936 |
Contract and collaboration revenue | 141 | 51 | 10 | 202 |
Total revenues | 19,855 | 193 | 11,415 | 31,463 |
Costs of goods sold | 79 | 318 | 4,577 | 4,974 |
Intangible assets impairment | 1,502 | 4,129 | -- | 5,631 |
Research and development expenses | 2,733 | 1,893 | 671 | 5,297 |
Depreciation and amortization | 140 | 116 | 7 | 263 |
Other operating expenses | 8,626 | 2,630 | 399 | 11,655 |
Income (loss) from operations | 6,775 | (8,893) | 5,761 | 3,643 |
Interest income | 24 | 2 | -- | 26 |
Interest expense | (343) | -- | (41) | (384) |
Other non-operating income (expense), net | 29 | (443) | 933 | 519 |
Income (loss) before income taxes | $ 6,485 | $ (9,334) | $ 6,653 | $ 3,804 |
Capital expenditures | $ 13 | $ -- | $ -- | $ 13 |
Three Months Ended September 30, 2013 | ||||
Research and development revenue | $ 2,027 | $ -- | $ -- | $ 2,027 |
Product royalty revenue | 13,595 | -- | -- | 13,595 |
Product sales revenue | 170 | 17 | 5,191 | 5,378 |
Co-promotion revenue | -- | -- | -- | -- |
Contract and collaboration revenue | 141 | 12 | 10 | 163 |
Total revenues | 15,933 | 29 | 5,201 | 21,163 |
Costs of goods sold | 3,389 | 4 | 2,874 | 6,267 |
Research and development expenses | 3,860 | (305) | 919 | 4,474 |
Depreciation and amortization | 309 | 47 | 8 | 364 |
Other operating expenses | 8,893 | 1,646 | 563 | 11,102 |
Income (loss) from operations | (518) | (1,363) | 837 | (1,044) |
Interest income | 18 | 2 | -- | 20 |
Interest expense | -- | (417) | (44) | (461) |
Other non-operating income, net | 6 | 95 | 82 | 183 |
Income (loss) before income taxes | $ (494) | $ (1,683) | $ 875 | $ (1,302) |
Capital expenditures | $ 9 | $ 4 | $ -- | $ 13 |
Nine Months Ended September 30, 2014 | ||||
Research and development revenue | $ 5,281 | $ -- | $ -- | $ 5,281 |
Product royalty revenue | 44,200 | -- | -- | 44,200 |
Product sales revenue | 551 | 297 | 24,724 | 25,572 |
Co-promotion revenue | 2,021 | -- | -- | 2,021 |
Contract and collaboration revenue | 424 | 165 | 30 | 619 |
Total revenues | 52,477 | 462 | 24,754 | 77,693 |
Cost of goods sold | 375 | 357 | 11,431 | 12,163 |
Intangible assets impairment | 1,502 | 4,129 | -- | 5,631 |
Research and development expenses | 7,565 | 4,528 | 2,591 | 14,684 |
Depreciation and amortization | 514 | 448 | 22 | 984 |
Other operating expenses | 25,306 | 7,364 | 1,378 | 34,048 |
Income (loss) from operations | 17,215 | (16,364) | 9,332 | 10,183 |
Interest income | 67 | 6 | 33 | 106 |
Interest expense | (1,054) | -- | (122) | (1,176) |
Other non-operating expense, net | 31 | 547 | (435) | 143 |
Income (loss) before income taxes | $ 16,259 | $ (15,811) | $ 8,808 | $ 9,256 |
Capital expenditures | $ 58 | $ 2 | $ 2 | $ 62 |
Nine Months Ended September 30, 2013 | ||||
Research and development revenue | $ 16,288 | $ -- | $ -- | $ 16,288 |
Product royalty revenue | 37,271 | -- | -- | 37,271 |
Product sales revenue | 277 | 37 | 10,680 | 10,994 |
Co-promotion revenue | 61 | -- | -- | 61 |
Contract and collaboration revenue | 424 | 34 | 32 | 490 |
Total revenues | 54,321 | 71 | 10,712 | 65,104 |
Cost of goods sold | 3,465 | 12 | 5,980 | 9,457 |
Research and development expenses | 6,446 | 4,307 | 3,775 | 14,528 |
Depreciation and amortization | 543 | 548 | 26 | 1,117 |
Other operating expenses | 27,368 | 3,374 | 2,743 | 33,485 |
Income (loss) from operations | 16,499 | (8,170) | (1,812) | 6,517 |
Interest income | 54 | 8 | 1 | 63 |
Interest expense | -- | (1,326) | (123) | (1,449) |
Other non-operating income (expense), net | (9) | (169) | 2,381 | 2,203 |
Income (loss) before income taxes | $ 16,544 | $ (9,657) | $ 447 | $ 7,334 |
Capital expenditures | $ 40 | $ 110 | $ 3 | $ 153 |
CONTACT: Sucampo Pharmaceuticals, Inc. Silvia Taylor Senior Vice President, Investor Relations and Corporate Communications 1-240-223-3718 staylor@sucampo.com