UNITED STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
D.C. 20549
FORM 8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date
of Report (Date of earliest event reported): November 2, 2012
Sucampo Pharmaceuticals, Inc. |
(Exact Name of Registrant as Specified in Charter) |
Delaware |
001-33609 |
30-0520478 |
(State or Other Jurisdiction of Incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) |
4520 East-West Highway, 3rd Floor Bethesda, Maryland |
20814 |
(Address of Principal Executive Offices) | (Zip Code) |
Registrant’s
telephone number, including area code: (301) 961-3400
(Former Name or Former Address, if Changed Since Last Report) |
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
⃞ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
⃞ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
⃞ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
⃞ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Item 2.02. Results of Operations and Financial Condition.
On November 8, 2012, Sucampo Pharmaceuticals, Inc. (“the Company”) announced its consolidated financial results for the quarter ended September 30, 2012. The full text of the press release issued in connection with the announcement is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The information in this Form 8-K (including Exhibit 99.1) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended (the “Securities Act”), or the Exchange Act, except as expressly set forth by specific reference in such a filing.
Item 7.01. Regulation FD Disclosure.
On November 8, 2012, the Company will provide a corporate presentation update during the financial results webcast, which will include written communication, comprised of slides. The slides from the presentation are being furnished as Exhibit 99.2 to this Current Report on Form 8-K.
The information in this Item 7.01 and Exhibit 99.2 to this Form 8-K shall not be deemed “filed” for purposes of Section 18 of the Exchange Act or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act or the Exchange Act, except as expressly set forth by specific reference in such a filing.
Item 8.01. Other Events.
On November 2, 2012, the Company’s Board of Directors authorized the increase in the repurchase of up to an aggregate of $5,000,000 from $2,000,000 of its class A common stock out of the $10,000,000 previously approved by the Board of Directors in December 2008. The repurchase program is expected to continue through to the third quarter of 2013 unless extended or shortened.
Item 9.01. Financial Statements and Exhibits.
(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 registrant on November 8, 2012. | ||
99.2 | The corporate update presentation slides dated November 8, 2012. |
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|
SUCAMPO PHARMACEUTICALS, INC. |
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Date: | November 8, 2012 | By: |
|
/s/ CARY J. CLAIBORNE |
|
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Name: |
Cary J. Claiborne |
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Title: |
Chief Financial Officer |
EXHIBIT INDEX
Exhibit No. |
Description |
99.1 |
Press release issued by the registrant on November 8, 2012 |
99.2 |
The corporate update presentation slides dated November 8, 2012 |
Exhibit 99.1
Sucampo Pharmaceuticals, Inc. Reports Third Quarter and Nine Months 2012 Financial and Operating Results
Record Royalty Revenue for Third Quarter
Conference Call Today at 5:00 pm Eastern
BETHESDA, Md.--(BUSINESS WIRE)--November 8, 2012--Sucampo Pharmaceuticals, Inc. (“Sucampo”), (NASDAQ: SCMP), a global pharmaceutical company, today reported its consolidated financial results for the quarter and nine months periods ended September 30, 2012.
For the third quarter of 2012, total revenue grew approximately 8%, to $15.5 million from $14.4 million for the same period in 2011. For the first nine months of 2012, total revenue grew by 15%, to $46.6 million from $40.5 million during the same period in 2011. Net sales of AMITIZA®, as reported to us by our partner, Takeda, increased 24.2%, to $71.5 million, for the third quarter of 2012, compared to $57.6 million in the same period of 2011. During the third quarter of 2012, R&D and G&A expenses declined, while selling and marketing expenses increased, reflecting continued investment in business growth and a focus on continued productivity.
“Sucampo accomplished several milestones this quarter that allowed us to fulfill our mission of bringing prostone-based medicines to patients who need them around the world. We achieved approval of AMITIZA in Japan, bringing us one step closer to the launch in the Japanese market. We also were granted approval of AMITIZA in the U.K., and made progress on our commercialization plans for that market and Switzerland. Sales of AMITIZA in the United States grew 24% for the third quarter, indicating that the product continues to grow steadily six years after launch. We were also excited to receive priority review status from the FDA for our sNDA filing of AMITIZA for opioid-induced constipation, or OIC. For RESCULA®, we moved closer to approval of a revised label and launch of the product in the United States,” said Ryuji Ueno, M.D., Ph.D., Ph.D., Chair of the Board and Chief Executive Officer of Sucampo. “Sucampo also made significant progress in advancing our deep pipeline of prostone-based compounds and in lifecycle management of our existing products, with initiation of a phase 1 trial for cobiprostone and the finalization of plans for phase 2 and 3 studies for our compound SPI-017 and AMITIZA in pediatrics, respectively.”
Sucampo reported a net loss of $5.9 million, or $0.14 per diluted share, for the third quarter of 2012 compared to a net loss of $4.1 million, or $0.10 per diluted share, for the third quarter of 2011. Sucampo reported a net loss of $8.7 million, or $0.21 per diluted share, for the first nine months of 2012, compared to a net loss of $20.0 million, or $0.48 per diluted share, for the prior year period. The primary driver of the net loss was a tax provision of $3.8 million for the third quarter of 2012 compared to a tax provision of $0.2 million for the third quarter of 2011. The increase in the tax provision was primarily driven by tax expense on pre-tax profits in our US & Japanese subsidiaries, partially offset by a net discrete benefit related to our intellectual property transfer.
For the third quarter of 2012, income from operations was a loss of $1.6 million, a decrease of $2.9 million or 63%, compared to a loss from operations of $4.5 million for the third quarter of 2011. For the first nine months of 2012, income from operations was a loss of $4.6 million, a decrease of $16.7 million or 78%, compared to a loss from operations of $21.3 million in the same period last year.
Recent Operational Highlights –
Key Value Drivers
Sucampo management today reported that it has met four of its 2012 AMITIZA-related value drivers:
Management confirmed that it continues to pursue the following 2012 and early 2013 AMITIZA-related value drivers:
Management also confirmed continuing efforts to achieve this 2012 and early 2013 RESCULA-related value driver:
Financial Results for the Quarter and First Nine Months of 2012
For the third quarter of 2012, Sucampo reported total revenue of $15.5 million compared to $14.4 million for the same period in 2011, a growth of 7.8%. The key components of revenue for the third quarter included product royalty revenue of $13.9 million and R&D revenue of $0.7 million, which compare to $10.6 million and $2.9 million, respectively, in the same period of 2011. For the first nine months of 2012, Sucampo reported total revenue of $46.6 million, compared to $40.5 million for the same period in 2011, a growth of 15.0%. The key components of total revenue for the nine month period were product royalty revenue of $36.5 million and R&D revenue of $6.4 million, which compares to $30.7 million and $6.6 million, respectively, for the same period of 2011. The decrease in R&D revenue in the third quarter was primarily due to lower activity associated with the completion of the phase 3 OIC trial for AMITIZA. Net sales of AMITIZA, as reported to us by our partner, increased 24.2%, to $71.5 million, for the third quarter of 2012, compared to $57.6 million in the same period of 2011. The increase in AMITIZA net sales was primarily due to both volume and price increases, compared to the third quarter of 2011, as reported to us by our partner.
Operating Expenses
R&D expenses were $5.6 million for the third quarter of 2012, compared to $8.7 million for the third quarter of 2011. For the first nine months of 2012, R&D expenses were $14.2 million, compared to $25.8 million for the same period of 2011. For both periods, the decrease was primarily due to higher expenses in 2011 associated with the phase 3 trial of lubiprostone for OIC patients.
G&A expenses were $7.3 million for the third quarter of 2012, compared to $7.9 million for the third quarter of 2011. G&A expenses were $22.6 million for the first nine months of 2012, compared to $29.3 million for the prior year period. For both periods, 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, partially offset by increases in corporate marketing and branding and staff organizations to support business growth.
Selling and marketing expenses were $4.3 million for third quarter of 2012, compared to $2.2 million for the third quarter of 2011. Selling and marketing expenses were $14.5 million for the first nine months of 2012 compared to $6.7 million for the prior year period. The increase in selling and marketing expenses relates primarily to some non-recurring pre-commercialization planning activities for AMITIZA and RESCULA.
Income from Operations
For the third quarter of 2012, income from operations was a loss of $1.6 million, a decrease of $2.9 million or 63%, compared to a loss from operations of $4.5 million for the third quarter of 2011. For the first nine months of 2012, income from operations was a loss of $4.6 million, a decrease of $16.7 million or 78%, compared to a loss from operations of $21.3 million in the same period last year.
Non-Operating Income (Expense)
Non-operating expenses were $0.5 million for the third quarter of 2012, compared to income of $0.6 million for the same period in 2011. The third quarter of 2012 includes a foreign exchange gain of $8,000 compared to a gain of $1.2 million in the same period in 2011. Non-operating expenses were $0.9 million for the nine months ended September 30, 2012, compared to $3.7 million for the same period in 2011. Non-operating expenses for the nine months ended September 30, 2012, included a foreign exchange gain of $0.7 million, compared to foreign exchange loss of $2.0 million for the same period 2011.
Net Loss
Net loss for the third quarter of 2012 was $5.9 million, compared to net loss of $4.1 million for the same period in 2011. Net loss for the first nine months of 2011 was $8.7 million, compared to a net loss of $20.0 million for the same period in 2011.
Comprehensive Loss
Comprehensive loss for the third quarter of 2012 was $6.1 million, compared to comprehensive loss of $6.1 million for the same period in 2011. Comprehensive loss for the first nine months of 2012 was $10.4 million, compared to comprehensive loss of $18.7 million for the same period in 2011.
Cash, Cash Equivalents, Restricted Cash and Marketable Securities
At September 30, 2012, cash, cash equivalents, restricted cash and investments were $82.1 million, compared to $93.4 million at December 31, 2011. At September 30, 2012, notes payable were $61.2 million, compared to $59.6 million at December 31, 2011. These include current notes payable of $20.3 million at September 30, 2012, compared to $20.4 million at December 31, 2011.
Conversion of Class B common stock
On August 30, 2012, Sucampo announced that its majority shareholder and only holder of its class B common stock, S&R Technology Holdings, LLC, or S&R, had converted all of its 26,191,050 issued and outstanding shares of Sucampo’s class B common stock into shares of Sucampo’s class A common stock. S&R held all of Sucampo’s class B common stock. Class B common stock holders were entitled to ten votes per share while class A common stock holders were entitled to one vote per share. Sucampo’s articles of incorporation permit the holder of class B common stock to convert the shares of class B common stock into shares of class A common stock at any time and on a one-for-one basis. As a result of the conversion, there is now only a single class of Sucampo’s common stock outstanding, totaling 41,905,364 shares, each of which is entitled to one vote per share.
Board Classification
In accordance with Sucampo’s articles of incorporation, upon the date of the conversion of the class B stock to class A stock, Sucampo’s Board of Directors was automatically divided into three classes. All directors within a class have the same three-year term of office. The class terms expire at successive annual meetings so that each year a class of directors is elected. The current terms of director classes expire in 2013 (Class I directors), 2014 (Class II directors), and 2015 (Class III directors).
Stock Repurchase Plan
In September 2011, the Board of Directors approved a program to repurchase our class A common stock under the previously approved repurchase plan, up to an aggregate of $2.0 million. On November 2, 2012, our Board authorized the increase of the amount of the program up to an aggregate of $5.0 million. During the third quarter of 2012, we repurchased 123,135 shares at a cost of $555,809.
Company to Host Conference Call Today
In conjunction with this third 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 866-788-0545 (domestic) or 857-350-1683 (international), and provide the participant passcode 34887168, 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 21448920.
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 unoprostone isopropyl (RESCULA®)
Sucampo holds development and commercialization rights to unoprostone isopropyl throughout the world except in Japan, Korea, Taiwan and the People’s Republic of China. Unoprostone isopropyl (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.
About lubiprostone (AMITIZA®)
AMITIZA (lubiprostone) is a prostone, a locally acting chloride channel activator, indicated for the treatment of CIC (24 mcg twice daily) in adults and for IBS-C (8 mcg twice daily) in women 18 years of age and older in the United States. 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 chronic idiopathic constipation. In the U.K., lubiprostone 24 mcg twice daily is indicated for the treatment of chronic idiopathic constipation and associated symptoms in adults.
About Sucampo Pharmaceuticals, Inc.
Sucampo Pharmaceuticals, Inc. is a global pharmaceutical company focused on innovative research, discovery, development and commercialization of proprietary drugs based on prostones. The therapeutic potential of prostones was first discovered by Ryuji Ueno, M.D., Ph.D., Ph.D., Sucampo’s Chairman, Chief Executive Officer, and co-founder. Prostones, naturally occurring fatty acid metabolites that have emerged as promising compounds with unique physiological activities, can be targeted for the treatment of unmet or underserved medical needs. For more information, please visit www.sucampo.com.
AMITIZA is a registered trademark of Sucampo AG. RESCULA is a registered trademark of R-Tech Ueno, Ltd, and has been licensed to Sucampo.
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 launch or regulatory approval, 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; competitive products entering the markets in which Sucampo’s products are marketed; 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 Form 10-K for the year ended December 31, 2011, which Sucampo incorporates by reference.
Sucampo Pharmaceuticals, Inc. | ||||||||||||||||||||
Condensed Consolidated Statements of Comprehensive Income (Loss) (unaudited) | ||||||||||||||||||||
(in thousands, except per share data) | ||||||||||||||||||||
Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||||||
2012 | 2011 | 2012 | 2011 | |||||||||||||||||
Revenues: | ||||||||||||||||||||
Research and development revenue | $ | 737 | $ | 2,885 | $ | 6,418 | $ | 6,591 | ||||||||||||
Product royalty revenue | 13,890 | 10,563 | 36,521 | 30,724 | ||||||||||||||||
Co-promotion revenue | 730 | 769 | 3,253 | 2,768 | ||||||||||||||||
Contract and collaboration revenue | 139 | 155 | 433 | 463 | ||||||||||||||||
Total revenues | 15,496 | 14,372 | 46,625 | 40,546 | ||||||||||||||||
Operating expenses: | ||||||||||||||||||||
Research and development | 5,615 | 8,725 | 14,202 | 25,838 | ||||||||||||||||
General and administrative | 7,256 | 7,926 | 22,598 | 29,317 | ||||||||||||||||
Selling and marketing | 4,278 | 2,243 | 14,474 | 6,689 | ||||||||||||||||
Total operating expenses | 17,149 | 18,894 | 51,274 | 61,844 | ||||||||||||||||
Loss from operations | (1,653 | ) | (4,522 | ) | (4,649 | ) | (21,298 | ) | ||||||||||||
Non-operating income (expense): | ||||||||||||||||||||
Interest income | 68 | 35 | 118 | 160 | ||||||||||||||||
Interest expense | (596 | ) | (619 | ) | (1,780 | ) | (1,844 | ) | ||||||||||||
Other income (expense), net | 8 | 1,224 | 727 | (2,033 | ) | |||||||||||||||
Total non-operating income (expense), net | (520 | ) | 640 | (935 | ) | (3,717 | ) | |||||||||||||
Loss before income taxes | (2,173 | ) | (3,882 | ) | (5,584 | ) | (25,015 | ) | ||||||||||||
Income tax provision | (3,776 | ) | (196 | ) | (3,112 | ) | 5,009 | |||||||||||||
Net loss | $ | (5,949 | ) | $ | (4,078 | ) | $ | (8,696 | ) | $ | (20,006 | ) | ||||||||
Net loss per share: | ||||||||||||||||||||
Basic net loss per share | $ | (0.14 | ) | $ | (0.10 | ) | $ | (0.21 | ) | $ | (0.48 | ) | ||||||||
Diluted net loss per share | $ | (0.14 | ) | $ | (0.10 | ) | $ | (0.21 | ) | $ | (0.48 | ) | ||||||||
Weighted average common shares outstanding - basic | 41,678 | 41,877 | 41,697 | 41,864 | ||||||||||||||||
Weighted average common shares outstanding - diluted | 41,678 | 41,877 | 41,697 | 41,864 | ||||||||||||||||
Comprehensive loss: | ||||||||||||||||||||
Net loss | $ | (5,949 | ) | $ | (4,078 | ) | $ | (8,696 | ) | $ | (20,006 | ) | ||||||||
Other comprehensive income (loss): | ||||||||||||||||||||
Unrealized gain on investments, net of tax effect | 28 | 100 | 23 | 108 | ||||||||||||||||
Foreign currency translation | (175 | ) | (2,121 | ) | (1,767 | ) | 1,161 | |||||||||||||
Comprehensive income (loss) | $ | (6,096 | ) | $ | (6,099 | ) | $ | (10,440 | ) | $ | (18,737 | ) | ||||||||
Sucampo Pharmaceuticals, Inc. | ||||||||||
Condensed Consolidated Balance Sheets (Unaudited) | ||||||||||
(in thousands, except share data) | ||||||||||
September 30, | December 31, | |||||||||
2012 | 2011 | |||||||||
ASSETS: | ||||||||||
Current assets: | ||||||||||
Cash and cash equivalents | $ | 57,246 | $ | 50,662 | ||||||
Investments, current | 6,229 | 24,452 | ||||||||
Product royalties receivable | 13,346 | 10,795 | ||||||||
Unbilled accounts receivable | 571 | 2,036 | ||||||||
Accounts receivable, net | 1,235 | 4,616 | ||||||||
Prepaid and income taxes receivable | 3,316 | 2,845 | ||||||||
Deferred tax assets, current | 33 | 163 | ||||||||
Deferred charge, current | 673 | 3,057 | ||||||||
Restricted cash, current | 15,113 | 15,113 | ||||||||
Prepaid expenses and other current assets | 2,611 | 1,177 | ||||||||
Total current assets | 100,373 | 114,916 | ||||||||
Investments, non-current | - | 998 | ||||||||
Property and equipment, net | 1,563 | 1,669 | ||||||||
Intangibles assets, net | 7,660 | 8,364 | ||||||||
Deferred tax assets, non-current | 1,728 | 2,089 | ||||||||
Deferred charge, non-current | 5,381 | 26,751 | ||||||||
Restricted cash, non-current | 3,548 | 2,129 | ||||||||
Other assets | 878 | 653 | ||||||||
Total assets | $ | 121,131 | $ | 157,569 | ||||||
LIABILITIES AND STOCKHOLDERS' EQUITY: | ||||||||||
Current liabilities: | ||||||||||
Accounts payable | $ | 3,455 | $ | 6,978 | ||||||
Accrued expenses | 8,800 | 13,648 | ||||||||
Deferred revenue, current | 3,841 | 3,888 | ||||||||
Deferred tax liability, current | 51 | 2,167 | ||||||||
Notes payable, current | 20,300 | 20,400 | ||||||||
Total current liabilities | 36,447 | 47,081 | ||||||||
Notes payable, non-current | 40,883 | 39,227 | ||||||||
Deferred revenue, non-current | 7,101 | 7,045 | ||||||||
Deferred tax liability, non-current | 5,125 | 23,019 | ||||||||
Other liabilities | 2,211 | 2,603 | ||||||||
Total liabilities | 91,767 | 118,975 | ||||||||
Stockholders' equity: | ||||||||||
Preferred stock, $0.01 par value; 5,000,000 shares authorized at September 30, 2012 and December 31, 2011; no shares issued and outstanding at September 30, 2012 and December 31, 2011 |
- | - | ||||||||
Class A common stock, $0.01 par value; 270,000,000 shares authorized at September 30, 2012 and December 31, 2011; 41,901,785 and 15,690,780 shares issued and outstanding at September 30, 2012 and December 31, 2011, respectively |
419 | 157 | ||||||||
Class B common stock, $0.01 par value; 0 and 75,000,000 shares authorized at September 30, 2012 and December 31, 2011; 0 and 26,191,050 shares issued and outstanding at September 30, 2012 and December 31, 2011, respectively |
- | 262 | ||||||||
Additional paid-in capital | 61,723 | 59,957 | ||||||||
Accumulated other comprehensive income | 16,110 | 17,854 | ||||||||
Treasury stock, at cost; 310,122 and 186,987 shares at September 30, 2012 and December 31, 2011, | (1,256 | ) | (700 | ) | ||||||
respectively | (47,632 | ) | (38,936 | ) | ||||||
Accumulated deficit | 29,364 | 38,594 | ||||||||
Total liabilities and stockholders' equity | $ | 121,131 | $ | 157,569 | ||||||
Sucampo Pharmaceuticals, Inc. | ||||||||||||||||||||
Key Segment Information (unaudited) | ||||||||||||||||||||
(in thousands) | ||||||||||||||||||||
(In thousands) | Americas | Europe | Asia | Consolidated | ||||||||||||||||
Three Months Ended September 30, 2012 | ||||||||||||||||||||
Research and development revenue | $ | 665 | $ | 72 | $ | - | $ | 737 | ||||||||||||
Product royalty revenue | 13,890 | - | - | 13,890 | ||||||||||||||||
Co-promotion revenue | 730 | - | - | 730 | ||||||||||||||||
Contract and collaboration revenue | 141 | (15 | ) | 13 | 139 | |||||||||||||||
Total revenues | 15,426 | 57 | 13 | 15,496 | ||||||||||||||||
Research and development expenses | 2,239 | 2,543 | 833 | 5,615 | ||||||||||||||||
Depreciation and amortization | 122 | 242 | 10 | 374 | ||||||||||||||||
Other operating expenses | 9,677 | 1,161 | 322 | 11,160 | ||||||||||||||||
Income (loss) from operations | 3,388 | (3,889 | ) | (1,152 | ) | (1,653 | ) | |||||||||||||
Interest income | 65 | 3 | - | 68 | ||||||||||||||||
Interest expense | - | (556 | ) | (40 | ) | (596 | ) | |||||||||||||
Other non-operating income (expense), net | 34 | 165 | (191 | ) | 8 | |||||||||||||||
Income (loss) before income taxes | $ | 3,487 | $ | (4,277 | ) | $ | (1,383 | ) | $ | (2,173 | ) | |||||||||
Capital expenditures | $ | 41 | $ | - | $ | - | $ | 41 | ||||||||||||
Three Months Ended September 30, 2011 | ||||||||||||||||||||
Research and development revenue | $ | 2,658 | $ | - | $ | 227 | $ | 2,885 | ||||||||||||
Product royalty revenue | 10,563 | - | - | 10,563 | ||||||||||||||||
Co-promotion revenue | 769 | - | - | 769 | ||||||||||||||||
Contract and collaboration revenue | 141 | - | 14 | 155 | ||||||||||||||||
Total revenues | 14,131 | - | 241 | 14,372 | ||||||||||||||||
Research and development expenses | 6,552 | 965 | 1,208 | 8,725 | ||||||||||||||||
Depreciation and amortization | 215 | 167 | (6 | ) | 376 | |||||||||||||||
Other operating expenses | 9,014 | 403 | 376 | 9,793 | ||||||||||||||||
Loss from operations | (1,650 | ) | (1,535 | ) | (1,337 | ) | (4,522 | ) | ||||||||||||
Interest income | 32 | 2 | 1 | 35 | ||||||||||||||||
Interest expense | - | (576 | ) | (43 | ) | (619 | ) | |||||||||||||
Other non-operating income (expense), net | (10 | ) | 1,463 | (229 | ) | 1,224 | ||||||||||||||
Loss before income taxes | $ | (1,628 | ) | $ | (646 | ) | $ | (1,608 | ) | $ | (3,882 | ) | ||||||||
Capital expenditures | $ | 15 | $ | 3 | $ | 86 | $ | 104 | ||||||||||||
Nine Months Ended September 30, 2012 | ||||||||||||||||||||
Research and development revenue | $ | 5,878 | $ | 74 | $ | 466 | $ | 6,418 | ||||||||||||
Product royalty revenue | 36,521 | - | - | 36,521 | ||||||||||||||||
Co-promotion revenue | 3,253 | - | - | 3,253 | ||||||||||||||||
Contract and collaboration revenue | 424 | (30 | ) | 39 | 433 | |||||||||||||||
Total revenues | 46,076 | 44 | 505 | 46,625 | ||||||||||||||||
Research and development expenses | 6,250 | 5,405 | 2,547 | 14,202 | ||||||||||||||||
Depreciation and amortization | 366 | 709 | 30 | 1,105 | ||||||||||||||||
Other operating expenses | 32,475 | 2,576 | 916 | 35,967 | ||||||||||||||||
Income (loss) from operations | 6,985 | (8,646 | ) | (2,988 | ) | (4,649 | ) | |||||||||||||
Interest income | 105 | 12 | 1 | 118 | ||||||||||||||||
Interest expense | - | (1,656 | ) | (124 | ) | (1,780 | ) | |||||||||||||
Other non-operating income (expense), net | 67 | 82 | 578 | 727 | ||||||||||||||||
Income (loss) before income taxes | $ | 7,157 | $ | (10,208 | ) | $ | (2,533 | ) | $ | (5,584 | ) | |||||||||
Capital expenditures | $ | 293 | $ | 3,445 | $ | - | $ | 3,738 | ||||||||||||
Nine Months Ended September 30, 2011 | ||||||||||||||||||||
Research and development revenue | $ | 5,555 | $ | - | $ | 1,036 | $ | 6,591 | ||||||||||||
Product royalty revenue | 30,724 | - | - | 30,724 | ||||||||||||||||
Co-promotion revenue | 2,768 | - | - | 2,768 | ||||||||||||||||
Contract and collaboration revenue | 424 | - | 39 | 463 | ||||||||||||||||
Total revenues | 39,471 | - | 1,075 | 40,546 | ||||||||||||||||
Research and development expenses | 19,465 | 2,352 | 4,021 | 25,838 | ||||||||||||||||
Depreciation and amortization | 668 | 325 | 33 | 1,026 | ||||||||||||||||
Other operating expenses | 33,232 | 807 | 941 | 34,980 | ||||||||||||||||
Loss from operations | (13,894 | ) | (3,484 | ) | (3,920 | ) | (21,298 | ) | ||||||||||||
Interest income | 155 | 3 | 2 | 160 | ||||||||||||||||
Interest expense | - | (1,719 | ) | (125 | ) | (1,844 | ) | |||||||||||||
Other non-operating income (expense), net | (21 | ) | (1,779 | ) | (233 | ) | (2,033 | ) | ||||||||||||
Loss before income taxes | $ | (13,760 | ) | $ | (6,979 | ) | $ | (4,276 | ) | $ | (25,015 | ) | ||||||||
Capital expenditures | $ | 93 | $ | 6,003 | $ | 188 | $ | 6,284 | ||||||||||||
CONTACT:
Sucampo Pharmaceuticals, Inc.
Silvia Taylor,
1-240-223-3718
staylor@sucampo.com
or
Kate de Santis,
1-240-223-3834
kdesantis@sucampo.com
Exhibit 99.2
Third Quarter 2012 Results 1
Agenda Introductions and Forward-Looking Statements Silvia Taylor Highlights of the Quarter Ryuji Ueno, MD, PhD, PhD Commercial Update Andrew Smith, Stanley G. Miele Pipeline and R&D Update Peter Lichtlen, MD, PhD Financial Performance Cary J. Claiborne Closing Remarks Ryuji Ueno, MD, PhD, PhD 2
Forward-Looking Statements This presentation 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 that 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 healthcare 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 US and internationally and the exposure to litigation actions internationally, 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 Form 10-Q, August 9, 2012 and Form 10-K for the year ended Dec 31, 2011, which the company incorporates by reference. 3
Q3 2012 Highlights Ryuji Ueno, MD, PhD, PhD Chairman, Chief Executive Officer, Chief Scientific Officer, and Co-founder
Q3 2012 Highlights AMITIZA Approval in Japan (CC) and UK (CIC) Abbott Japan will launch later this month $15M milestone payment upon first sale in Japan Swiss reimbursement FDA priority review sNDA (OIC) $10M milestone payment upon first OIC sale US: Net sales up 24% RESCULA US Launch prep Pipeline Initiated P1 trial of SPI-8811, cobiprostone (oral mucositis; new formulation) Initiate P2 trial of SPI-017 (management of severely symptomatic lumbar spinal stenosis) 5
Commercial Update Andrew Smith Vice President of Operations and Finance Stanley G. Miele President, Sucampo Pharma Americas and SVP, Sales and Marketing
AMITIZA Japan and Europe Japan First-ever prescription medicine approved for chronic constipation Abbott launch late November Extensive sales and marketing by Abbott Japan $15 million milestone payment Leadership share of voice in Japanese market for AMITIZA Europe/UK Swiss reimbursement price Plan to commence active marketing in Q1 2013 UK approval (CIC) Planning launch ourselves in Q1 2013 Target high-potential prescribers Begin mutual recognition procedure for additional EU CIC approvals starting in 2013 Filing for regulatory approval of the OIC indication in UK and Switzerland by end of 2012 7
AMITIZA US Net sales increase: 24% Total Rx growth: 6% Increased awareness of CIC and IBS-C disease states Over 6 million prescriptions over 6 years Growth trajectory expected to continue sNDA Moderate to severe OIC affects between 2 and 2.5 million non-cancer, chronic pain patients in the US. Unmet need: most patients and HCPs are dissatisfied with their current treatment options for OIC Primary care physicians prescribe majority of these patients FDA action: expected late January 2013 8
RESCULA US sNDA approval expected Q4 2012 New label: reflect current scientific understanding of unique mechanism of action be approved for first-line treatment Launch RESCULA upon getting the sNDA approval 9
Pipeline and & R&D Update Peter Lichtlen, MD, PhD Senior Medical Officer and Vice President, European Operations
AMITIZA sNDA in OIC Priority review granted Orally-administered drug with strong safety record Laxatives have not been shown to be effective in treating OIC FDA decision early 2013 P3 pediatric trials Q1 2013 New pediatric functional constipation indication Development of new liquid formulation Takeda funding significant amount of development costs for pediatric indication, and 100% of development costs for liquid formulation 11
SPI-017 for Lumbar Spinal Stenosis LSS caused by degenerative change in lumbar spine; very common disease observed in growing aged population Unmet medical need P2 trial dosing early 2013 in Japan 12
SPI-8811 (cobiprostone) for Oral Mucositis Oral mucositis is a common toxicity of cancer treatments Unmet medical need New indication for SPI-8811 (cobiprostone) – oral mucositis Symptoms: Pain; xerostomia; dysphagia, including feeding-tube dependency; dehydration; infections; potentially life-threatening aspiration Unmet medical need P1 trial in healthy volunteers initiated New oral spray formulation 13
Financial Performance Cary J. Claiborne Chief Financial Officer
Q3 2012 Financial Highlights $M +8% +31% +24% $14.4 $15.5 $10.6 $13.9 $57.6 $71.5 Q3-11 Q3-12 Q3-11 Q3-12 Q3-11 Q3-12 Total Revenues Product Royalty Revenue AMITIZA Net Sales 15
Q3 2012 Financial Highlights $M except EPS Q3 2011 Q3 2012 Operating Income ($4.5) ($1.6) Net Income ($4.1) ($5.9) EPS ($0.10) ($0.14) R&D $8.7 $5.6 G&A $7.9 $7.3 Selling & Marketing $2.2 $4.3 16
Q3 2012 Financial Highlights Cash position $82.1 million as of September 30, 2012 Repurchased 123,135 shares during quarter Recently raised authorized amount to $5,000,000 One class of common stock and staggered board 17
Closing Remarks Ryuji Ueno, MD, PhD, PhD Chairman, Chief Executive Officer, Chief Scientific Officer, and Co-founder
Key Value Drivers Completed In Process AMITIZA US Filed OIC sNDA: Q3 2012 OIC filing accepted by FDA for priority review Decision in Takeda arbitration resolved dispute Switzerland Reached agreement on reimbursement price Begin active marketing Q1 2013 Submit for regulatory approval of OIC Japan Approved in Japan for CC: Q2 2012 Await pricing decision: Nov ‘12 Launch: Nov ‘12 ($15M milestone and product sales) EU Approved in UK for CIC: Q3 2012 Launch Q1 2013 Submit for regulatory approval of OIC RESCULA US Obtain approval of sNDA (updated label) Launch: shortly after approval of sNDA 19
Q&A