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): March 13, 2013
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 March 13, 2013, Sucampo Pharmaceuticals, Inc. (“the Company”) announced its consolidated financial results for the fourth quarter and year ended December 31, 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 slides from the presentation and the transcript of the webcast referenced below are incorporated by reference.
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 March 13, 2013, the Company hosted a conference call with investors to discuss the Company's financial and operating results for the fourth quarter and fiscal year 2012 ended December 31, 2012. The conference call including slides was made available to the public via conference call and webcast. The slides from the presentation are being furnished as Exhibit 99.2 and the transcript is being furnished as Exhibit 99.3 to this Current Report on Form 8-K.
The information in this Item 7.01 and Exhibits 99.2 and 99.3 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 9.01 Financial Statements and Exhibits
(d) |
Exhibits |
|
The following exhibit relating to Items 2.02 shall be deemed to be furnished, and not filed: |
||
99.1 Press Release issued by the registrant on March 13, 2013. |
||
99.2 The corporate update presentation slides dated March 13, 2013. |
||
99.3 Transcript of March 13, 2013 investor conference call dated March 13, 2013. |
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. |
||||
|
|||||
Date: |
March 15, 2013 |
By: |
/s/ Thomas J. Knapp |
||
|
Name: |
Thomas J. Knapp |
|||
|
Title: |
EVP, Chief Legal Officer and Corporate Secretary |
Exhibit 99.1
Sucampo Pharmaceuticals, Inc. Reports Fourth Quarter and Full Year 2012 Financial and Operating Results
Fourth Quarter Net Income Reported of $13.5 million; Full-Year Net Income Reported of $4.8 million;
Fourth Quarter Total Revenues Increased 145% to $34.9 million; Full-Year Revenues Increased 49% to $81.5 million;
Company to Host Conference Call Today at 5:00 pm Eastern
BETHESDA, Md.--(BUSINESS WIRE)--March 13, 2013--Sucampo Pharmaceuticals, Inc. (“Sucampo”) (NASDAQ: SCMP), a global pharmaceutical company, today reported its consolidated financial results for the quarter and full year ending December 31, 2012.
For the fourth quarter of 2012, total revenue grew approximately 145%, to $34.9 million from $14.2 million for the same period in 2011. Net sales of AMITIZA® (lubiprostone), as reported to us by our partner increased 31% to $74.6 million for the fourth quarter of 2012, compared to $56.8 million in the same period of 2011. During the fourth quarter of 2012, Sucampo reported product sales revenue and cost of goods sold primarily representing sales of AMITIZA to Abbott Japan Co., Ltd. (Abbott) in Japan. Sucampo reported $5.0 million of product sales revenue and $3.0 million of cost of goods sold compared to nil in 2011, respectively. Sucampo also received a $15.0 million milestone payment from Abbott associated with the initial sale of AMITIZA in Japan.
“This was a tremendous year of achievement for Sucampo,” said Ryuji Ueno, M.D., Ph.D., Ph.D., Chairman, Chief Executive Officer, and Chief Scientific Officer of Sucampo. “With the approval of the sNDA for RESCULA®, we now have two FDA approved products marketed in the United States. As the first-ever prescription medicine approved in Japan for chronic constipation, we launched AMITIZA in Japan and received a $15 million milestone payment related to the first commercial sale of AMITIZA. We look forward to upcoming catalysts for 2013, including the continued rollout of RESCULA in the U.S., the PDUFA date for opioid-induced constipation for AMITIZA in the U.S., the launch of AMITIZA in the U.K. and Switzerland, and the continued development of our pipeline.”
Sucampo reported a net income of $13.5 million, or $0.32 per diluted share, for the fourth quarter of 2012 compared to a net income of $2.7 million, or $0.06 per diluted share, for the fourth quarter of 2011. Sucampo reported a net income of $4.8 million, or $0.12 per diluted share for the full year 2012, compared to a net loss of $17.3 million, or $0.41 per diluted share, for the full year 2011. The primary driver of the net profit was the $15.0 million milestone payment from Abbott for Japan AMITIZA sales.
For the fourth quarter of 2012, income from operations was $13.0 million, an increase of $9.4 million, compared to $3.6 million in income from operations for the fourth quarter of 2011. For the full year 2012, income from operations was $8.3 million, compared to a loss from operations of $17.7 million for the full year 2011.
Quarter Operational Highlights –
Key Value Drivers –
2012 Value Drivers Achieved:
AMITIZA
U.S.
Japan
Europe
RESCULA
Other
2013 Value Drivers:
Sucampo is pursuing the following value drivers in 2013:
AMITIZA
U.S.
Japan
Europe
RESCULA
Other
Oral Mucositis
Spinal Stenosis
As previously announced, in February R-Tech Ueno, Sucampo's development partner, signed an agreement for unoprostone isopropyl with the Japan Science and Technology Agency in which the Japanese government shall provide the majority of funding for phase 3 clinical development costs for unoprostone isopropyl for retinitis pigmentosa (RP). Sucampo is co-developing unoprostone isopropyl with R-Tech Ueno and may file for FDA approval of the product for RP in the future assuming the successful trials.
Financial Results for the Quarter and Full Year 2012
For the fourth quarter of 2012, Sucampo reported total revenue of $34.9 million compared to $14.2 million for the same period in 2011, a growth of approximately 145%. The key components of revenue for the fourth quarter included R&D revenue of $15.1 million, product royalty revenue of $14.2 million and product sales revenue of $5.0 million which compare to $2.7 million, $10.8 million and nil, respectively, in the same period of 2011.
For the full year 2012, Sucampo reported total revenue of $81.5 million, compared to $54.8 million for the full year 2011, a growth of approximately 49%. The key components of total revenue for the full year 2012 were product royalty revenue of $50.7 million, R&D revenue of $21.5 million and product sales revenue of $5.0 million compared to $41.5 million, $9.2 million and nil, respectively, for the full year 2011. The increase in R&D revenue was primarily due to the receipt of the $15.0 million milestone payment from Abbott upon the first commercial sale of AMITIZA at a dosage strength of 24 micrograms in Japanese adults.
U.S. net sales of AMITIZA, as reported to us by our partner, Takeda, increased 31% to $74.6 million for the fourth quarter of 2012, compared to $56.8 million in the same period of 2011. U.S. net sales of AMITIZA, as reported to us by our partner, Takeda, increased 20% to $271.9 million for the full year of 2012, compared to $226.4 million in the same period of 2011. For both periods the increase in AMITIZA U.S. net sales was primarily due to both volume and price increases, as reported to us by our partner.
Operating Expenses
R&D expenses were $7.1 million for the fourth quarter of 2012, compared to $7.7 million for the same period of 2011. For the full year 2012, R&D expenses were $21.3 million, compared to $33.5 million for the full year 2011. For both periods, the decrease was primarily due to higher expenses in 2011 associated with the completion of the phase 3 OIC trial for AMITIZA.
G&A expenses were $7.6 million for the fourth quarter of 2012, compared to $12.0 million for the fourth quarter of 2011. G&A expenses were $30.2 million for the full year 2012, compared to $41.3 million for the full year 2011. 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 to support business growth.
Selling and marketing expenses were $4.2 million for the fourth quarter of 2012, compared to $2.1 million for the fourth quarter of 2011. Selling and marketing expenses for the full year 2012 were $18.7 million, compared to $8.8 million for the full year 2011. The increase in selling and marketing expenses relates primarily to some non-recurring pre-commercialization planning activities for AMITIZA, and commercialization and launch costs for RESCULA.
Settlement of Legal Dispute in 2011 – In 2011 Sucampo reported income of $11.1 million from the settlement of a legal dispute related to a dispute with Covance, a CRO that performed clinical trials for the OBD or OIC indication. The amount represents receipt of $10.0 million in cash and cancellation of outstanding payables of $1.1 million and was reported as a reduction to operating expenses. There were no corresponding amounts in 2012.
Income from Operations
For the fourth quarter of 2012, income from operations was a profit of $13.0 million, an increase of $9.4 million, compared to a profit of $3.6 million for the same period in 2011. For the full year of 2012, income from operations was a profit of $8.3 million, compared to a loss of $17.7 million for the full year 2011.
Non-Operating Income (Expense)
Non-operating income was $0.4 million for the fourth quarter of 2012, compared to expenses of $0.5 million for the fourth quarter of 2011. The fourth quarter of 2012 included a foreign exchange gain of $0.9 million, compared to a gain of $14,000 for the same period 2011. Non-operating expenses for the full year 2012 were $0.6 million, compared to $4.2 million for the full year 2011. Non-operating expenses for the full year 2012 included a foreign exchange gain of $1.6 million, compared to foreign exchange loss of $2.0 million for the same period 2011.
Net Income
Net income for the fourth quarter of 2012 was $13.5 million, compared to net income of $2.7 million for the same period of 2011. For the full year 2012, net income was $4.8 million, compared to a net loss of $17.3 million for the full year 2011.
Comprehensive Income (Loss)
Comprehensive income for the full year of 2012 was $3.1 million, compared to comprehensive loss of $16.0 million for the same period in 2011. Comprehensive loss for the full year 2012 includes a $1.7 million foreign currency translation loss compared to a foreign currency translation gain of $1.3 million for the same period in 2011.
Cash, Cash Equivalents, Restricted Cash and Marketable Securities
At December 31, 2012, cash, cash equivalents, restricted cash and investments were $91.4 million, compared to $93.4 million at December 31, 2011. At December 31, 2012, notes payable were $52.9 million, compared to $59.6 million at December 31, 2011, including current notes payable of $19.1 million at December 31, 2012, and $20.4 million at December 31, 2011.
Stock Repurchase Plan
In September 2011, the Board of Directors authorized the repurchase of our class A common stock under the previously approved repurchase plan, up to an aggregate of $2.0 million. On November 2, 2012, the Board authorized the increase of the program amount up to an aggregate of $5.0 million. During the fourth quarter of 2012, we repurchased 146,908 shares at a cost of $721,487.
Board Members
In February 2013, the Board of Directors appointed Barbara A. Munder and Maureen E. O’Connell to the Board of Directors.
Company to Host Conference Call Today
In conjunction with this fourth 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 800-688-0836 (domestic) or 617-614-4072 (international), and provide the participant passcode 62809438, 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 95378400.
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®)
In 2009, 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 (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, Chief Scientific 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 Pharmaceuticals, Inc. RESCULA is a registered trademark of R-Tech Ueno, Ltd, and has been licensed to Sucampo AG.
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; 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 most recent Form 8-K and 10-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 December 31, | Year Ended December 31, | |||||||||||||||
2012 | 2011 | 2012 | 2011 | |||||||||||||
Revenues: | ||||||||||||||||
Research and development revenue | $ | 15,127 | $ | 2,658 | $ | 21,545 | $ | 9,249 | ||||||||
Product royalty revenue | 14,175 | 10,793 | 50,696 | 41,517 | ||||||||||||
Co-promotion revenue | 323 | 610 | 3,576 | 3,378 | ||||||||||||
Contract and collaboration revenue | 200 | 154 | 633 | 617 | ||||||||||||
Product sales revenue | 5,037 | - | 5,037 | - | ||||||||||||
Total revenues |
34,862 | 14,215 | 81,487 | 54,761 | ||||||||||||
Cost of goods sold | 3,030 | - | 3,030 | - | ||||||||||||
Gross profit | 31,832 | 14,215 | 78,457 | 54,761 | ||||||||||||
Operating expenses: | ||||||||||||||||
Research and development | 7,090 | 7,659 | 21,292 | 33,497 | ||||||||||||
Settlement of legal dispute | - | (11,100 | ) | - | (11,100 | ) | ||||||||||
General and administrative | 7,559 | 11,953 | 30,157 | 41,270 | ||||||||||||
Selling and marketing | 4,217 | 2,094 | 18,691 | 8,783 | ||||||||||||
Total operating expenses | 18,866 | 10,606 | 70,140 | 72,450 | ||||||||||||
Income (loss) from operations | 12,966 | 3,609 | 8,317 | (17,689 | ) | |||||||||||
Non-operating income (expense): | ||||||||||||||||
Interest income | 61 | 89 | 179 | 249 | ||||||||||||
Interest expense | (566 | ) | (611 | ) | (2,346 | ) | (2,455 | ) | ||||||||
Other income (expense), net | 875 | 14 | 1,602 | (2,019 | ) | |||||||||||
Total non-operating income (expense), net | 370 | (508 | ) | (565 | ) | (4,225 | ) | |||||||||
Income (loss) before income taxes | 13,336 | 3,101 | 7,752 | (21,914 | ) | |||||||||||
Income tax benefit (provision) | 196 | (402 | ) | (2,916 | ) | 4,608 | ||||||||||
Net income (loss) | $ | 13,532 | $ | 2,699 | $ | 4,836 | $ | (17,306 | ) | |||||||
Net income (loss) per share: | ||||||||||||||||
Basic net income (loss) per share | $ | 0.33 | $ | 0.06 | $ | 0.12 | $ | (0.41 | ) | |||||||
Diluted net income (loss) per share | $ | 0.32 | $ | 0.06 | $ | 0.12 | $ | (0.41 | ) | |||||||
Weighted average common shares outstanding - basic | 41,553 | 41,766 | 41,660 | 41,839 | ||||||||||||
Weighted average common shares outstanding - diluted | 41,991 | 41,832 | 41,785 | 41,839 | ||||||||||||
Comprehensive income (loss): | ||||||||||||||||
Net income (loss) | $ | 13,532 | $ | 2,699 | $ | 4,836 | $ | (17,306 | ) | |||||||
Other comprehensive income gain (loss): | ||||||||||||||||
Unrealized loss on investments, net of tax effect | 13 | (110 | ) | 36 | (2 | ) | ||||||||||
Foreign currency translation | 43 | 121 | (1,724 | ) | 1,282 | |||||||||||
Comprehensive income (loss) | $ | 13,588 | $ | 2,710 | $ | 3,148 | $ | (16,026 | ) | |||||||
Sucampo Pharmaceuticals, Inc. | ||||||||||
Consolidated Balance Sheets (unaudited) | ||||||||||
(in thousands, except share data) | ||||||||||
December 31, | ||||||||||
2012 | 2011 | |||||||||
ASSETS: | ||||||||||
Current assets: | ||||||||||
Cash and cash equivalents | $ | 52,022 | $ | 50,662 | ||||||
Investments, current | 6,035 | 24,452 | ||||||||
Product royalties receivable | 14,175 | 10,795 | ||||||||
Unbilled accounts receivable | 732 | 2,036 | ||||||||
Accounts receivable, net | 1,360 | 4,616 | ||||||||
Prepaid and income taxes receivable | - | 2,845 | ||||||||
Deferred tax assets, current | 874 | 163 | ||||||||
Deferred charge, current | 673 | 3,057 | ||||||||
Restricted cash, current | 15,113 | 15,113 | ||||||||
Prepaid expenses and other current assets | 1,930 | 1,177 | ||||||||
Total current assets | 92,914 | 114,916 | ||||||||
Investments, non-current | 14,408 | 998 | ||||||||
Property and equipment, net | 1,540 | 1,669 | ||||||||
Intangibles assets, net | 7,415 | 8,364 | ||||||||
Deferred tax assets, non-current | 1,654 | 2,089 | ||||||||
Deferred charge, non-current | 5,213 | 26,751 | ||||||||
Restricted cash, non-current | 3,832 | 2,129 | ||||||||
Other assets | 820 | 653 | ||||||||
Total assets | $ | 127,796 | $ | 157,569 | ||||||
LIABILITIES AND STOCKHOLDERS' EQUITY: | ||||||||||
Current liabilities: | ||||||||||
Accounts payable | $ | 5,496 | $ | 6,978 | ||||||
Accrued expenses | 10,595 | 13,648 | ||||||||
Deferred revenue, current | 3,700 | 3,888 | ||||||||
Deferred tax liability, current | - | 2,167 | ||||||||
Income tax payable | 148 | - | ||||||||
Notes payable, current | 19,129 | 20,400 | ||||||||
Other current liabilities | 1,003 | - | ||||||||
Total current liabilities | 40,071 | 47,081 | ||||||||
Notes payable, non-current | 33,722 | 39,227 | ||||||||
Deferred revenue, non-current | 7,093 | 7,045 | ||||||||
Deferred tax liability, non-current | 2,627 | 23,019 | ||||||||
Other liabilities | 1,253 | 2,603 | ||||||||
Total liabilities | 84,766 | 118,975 | ||||||||
Stockholders' equity: | ||||||||||
Preferred stock, $0.01 par value; 5,000,000 shares authorized at December 31, 2012 and 2011; no shares issued and outstanding at December 31, 2012 and 2011 |
- | - | ||||||||
Class A common stock, $0.01 par value; 270,000,000 shares authorized at December 31, 2012 and 2011; 41,964,905 and 15,690,780 shares issued and outstanding at December 31, 2012 and 2011, respectively |
420 | 157 | ||||||||
Class B common stock, $0.01 par value; 0 and 75,000,000 shares authorized at December 31, 2012 and 2011; 0 and 26,191,050 shares issued and outstanding at December 31, 2012 and 2011, respectively |
- | 262 | ||||||||
Additional paid-in capital | 62,521 | 59,957 | ||||||||
Accumulated other comprehensive income | 16,166 | 17,854 | ||||||||
Treasury stock, at cost; 457,030 and 186,987 shares | (1,977 | ) | (700 | ) | ||||||
Accumulated deficit | (34,100 | ) | (38,936 | ) | ||||||
Total stockholders' equity | 43,030 | 38,594 | ||||||||
Total liabilities and stockholders' equity | $ | 127,796 | $ | 157,569 | ||||||
Sucampo Pharmaceuticals, Inc. | ||||||||||||||||
Key Segment Information (unaudited) | ||||||||||||||||
(In thousands) | Americas | Europe | Asia | Consolidated | ||||||||||||
Three Months Ended December 31, 2012 | ||||||||||||||||
Research and development revenue | $ | 311 | $ | (74 | ) | $ | 14,890 | $ | 15,127 | |||||||
Product royalty revenue | 14,175 | - | - | 14,175 | ||||||||||||
Co-promotion revenue | 323 | - | - | 323 | ||||||||||||
Contract and collaboration revenue | 141 | 46 | 13 | 200 | ||||||||||||
Product sales revenue | - | 14 | 5,023 | 5,037 | ||||||||||||
Total revenues | 14,950 | (14 | ) | 19,926 | 34,862 | |||||||||||
Cost of goods sold | 98 | 9 | 2,923 | 3,030 | ||||||||||||
Gross profit | 14,852 | (23 | ) | 17,003 | 31,832 | |||||||||||
Research and development expenses | 1,559 | 4,166 | 1,365 | 7,090 | ||||||||||||
Depreciation and amortization | 118 | 255 | 10 | 383 | ||||||||||||
Other operating expenses | 8,935 | 417 | 2,041 | 11,393 | ||||||||||||
Income (loss) from operations | 4,240 | (4,861 | ) | 13,587 | 12,966 | |||||||||||
Interest income | 56 | 4 | 1 | 61 | ||||||||||||
Interest expense | - | (527 | ) | (39 | ) | (566 | ) | |||||||||
Other non-operating expense, net | 10 | (269 | ) | 1,134 | 875 | |||||||||||
Income (loss) before income taxes | $ | 4,306 | $ | (5,653 | ) | $ | 14,683 | $ | 13,336 | |||||||
Capital expenditures | $ | 108 | $ | 25 | $ | - | $ | 133 | ||||||||
Three Months Ended December 31, 2011 | ||||||||||||||||
Research and development revenue | $ | 2,478 | $ | - | $ | 180 | $ | 2,658 | ||||||||
Product royalty revenue | 10,793 | - | - | 10,793 | ||||||||||||
Co-promotion revenue | 610 | - | - | 610 | ||||||||||||
Contract and collaboration revenue | 141 | - | 13 | 154 | ||||||||||||
Total revenues | 14,022 | - | 193 | 14,215 | ||||||||||||
Research and development expenses | 4,593 | 2,002 | 1,064 | 7,659 | ||||||||||||
Settlement for legal dispute | (11,100 | ) | - | - | (11,100 | ) | ||||||||||
Depreciation and amortization | (133 | ) | 405 | 10 | 282 | |||||||||||
Other operating expenses | 13,094 | 285 | 386 | 13,765 | ||||||||||||
Income (loss) from operations | 7,568 | (2,692 | ) | (1,267 | ) | 3,609 | ||||||||||
Interest income | 85 | 3 | 1 | 89 | ||||||||||||
Interest expense | - | (569 | ) | (42 | ) | (611 | ) | |||||||||
Other non-operating expense, net | (21 | ) | (105 | ) | 140 | 14 | ||||||||||
Income (loss) before income taxes | $ | 7,632 | $ | (3,363 | ) | $ | (1,168 | ) | $ | 3,101 | ||||||
Capital expenditures | $ | 52 | $ | 3 | $ | - | $ | 55 | ||||||||
Year Ended December 31, 2012 | ||||||||||||||||
Research and development revenue | $ | 6,189 | $ | - | $ | 15,356 | $ | 21,545 | ||||||||
Product royalty revenue | 50,696 | - | - | 50,696 | ||||||||||||
Co-promotion revenue | 3,576 | - | - | 3,576 | ||||||||||||
Contract and collaboration revenue | 565 | 16 | 52 | 633 | ||||||||||||
Product sales revenue | - | 14 | 5,023 | 5,037 | ||||||||||||
Total revenues | 61,026 | 30 | 20,431 | 81,487 | ||||||||||||
Cost of goods sold | 98 | 9 | 2,923 | 3,030 | ||||||||||||
Gross profit | 60,928 | 21 | 17,508 | 78,457 | ||||||||||||
Research and development expenses | 7,809 | 9,571 | 3,912 | 21,292 | ||||||||||||
Depreciation and amortization | 484 | 964 | 40 | 1,488 | ||||||||||||
Other operating expenses | 41,410 | 2,993 | 2,957 | 47,360 | ||||||||||||
Income (loss) from operations | 11,225 | (13,507 | ) | 10,599 | 8,317 | |||||||||||
Interest income | 161 | 16 | 2 | 179 | ||||||||||||
Interest expense | - | (2,183 | ) | (163 | ) | (2,346 | ) | |||||||||
Other non-operating expense, net | 77 | (187 | ) | 1,712 | 1,602 | |||||||||||
Income (loss) before income taxes | $ | 11,463 | $ | (15,861 | ) | $ | 12,150 | $ | 7,752 | |||||||
Capital expenditures | $ | 401 | $ | 3,470 | $ | - | $ | 3,871 | ||||||||
Year Ended December 31, 2011 | ||||||||||||||||
Research and development revenue | $ | 8,033 | $ | - | $ | 1,216 | $ | 9,249 | ||||||||
Product royalty revenue | 41,517 | - | - | 41,517 | ||||||||||||
Co-promotion revenue | 3,378 | - | - | 3,378 | ||||||||||||
Contract and collaboration revenue | 565 | - | 52 | 617 | ||||||||||||
Total revenues | 53,493 | - | 1,268 | 54,761 | ||||||||||||
Research and development expenses | 24,058 | 4,354 | 5,085 | 33,497 | ||||||||||||
Settlement for legal dispute | (11,100 | ) | - | - | (11,100 | ) | ||||||||||
Depreciation and amortization | 791 | 474 | 43 | 1,308 | ||||||||||||
Other operating expenses | 46,326 | 1,092 | 1,327 | 48,745 | ||||||||||||
Income (loss) from operations | (6,582 | ) | (5,920 | ) | (5,187 | ) | (17,689 | ) | ||||||||
Interest income | 240 | 6 | 3 | 249 | ||||||||||||
Interest expense | - | (2,288 | ) | (167 | ) | (2,455 | ) | |||||||||
Other non-operating expense, net | (42 | ) | (1,884 | ) | (93 | ) | (2,019 | ) | ||||||||
Income (loss) before income taxes | $ | (6,384 | ) | $ | (10,086 | ) | $ | (5,444 | ) | $ | (21,914 | ) | ||||
Capital expenditures | $ | 145 | $ | 6,006 | $ | 133 | $ | 6,284 | ||||||||
CONTACT:
Sucampo Pharmaceuticals, Inc.
Silvia Taylor,
1-240-223-3718
staylor@sucampo.com
Exhibit 99.2
Fourth Quarter and Full Year 2012 Results
Introductions and Forward-Looking Statements Silvia TaylorSenior Vice President, Investor Relations, Public Relations and Corporate Communications
Introductions and Forward-Looking Statements Silvia Taylor Highlights of the Quarter and Year Ryuji Ueno, MD, PhD, PhD Commercial Update Stanley G. Miele Andrew Smith Pipeline and R&D Update Peter Lichtlen, MD, PhD Financial Performance Cary J. Claiborne Closing Remarks Ryuji Ueno, MD, PhD, PhD Agenda
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, 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; 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 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 8-K and 10-K, which Sucampo incorporates by reference. Forward-Looking Statements
Q4 and FY 2012 Highlights Ryuji Ueno, MD, PhD, PhDChairman, Chief Executive Officer, Chief Scientific Officer, and Co-founder
Highlights Abbott Japan launched in Japan for CC; $15M milestone payment receivedStrong US sales growth – Q4 up 31.3% in U.S. to $74.6 millionUS label update approvedOIC indication PDUFA date April 2013Reached agreement on Swiss reimbursement priceUK approval for CICAMITIZA sNDA approvedLaunched with our own sales force; initial feedback positive RESCULA Pipeline P1 trial of SPI-8811, cobiprostone, for oral mucositis on trackInitiated P2 trial of SPI-017 and P1 program for SPI-3608 for severely symptomatic lumbar spinal stenosisR-Tech Ueno, Ltd. (RTU) received funding from the Japan Science and Technology Agency for P3 program in retinitis pigmentosa using unoprostone isopropyl
Commercial Update Andrew SmithVice President of Operations and Finance Stanley G. MielePresident, Sucampo Pharma Americas and SVP, Sales and Marketing
RESCULA US Other Placeholder: sNDA approved December 2012Patients with open-angle glaucoma or ocular hypertensionIn the US: 2 million US glaucoma patients1, additional 3-6 million with ocular hypertension2Unique mechanism of action (BK channel activator) and well-tolerated safety profileLaunched with our own sales forceExpect 11% share of voicePositive feedback and significant progressMore than 5,000 face-to-face callsOver 50,000 samples shipped47 face-to-face meetings with plans and PBMs See References 1-2
Other Placeholder: January 2013 second highest month of TRx ever (+9.7%)Q4 TRx and NRx growth: 6% YoYQ4 net sales increase: up 31.3% to $74.6 millionOver 7 million prescriptions over 7 yearsGrowth trajectory expected to continuesNDA for OICPDUFA date April 2013Unmet need: 2-2.5 million moderate to severe non-cancer, chronic pain patients, most dissatisfied with current treatment options3-6$10 million milestone payment upon first sale for OIC AMITIZA US See References 3-6
AMITIZA Japan and Europe Abbott Japan launch late November$15 million milestone payment received in Q4First-ever prescription medicine approved for chronic constipationQ4 product sales at $5 million On track to commence active marketing (CIC) in SwitzerlandUK approval (CIC)On track to launch ourselves Initiated NICE endorsement processFiling for approval for CIC in other EU markets this year using MRP OIC indication recently filed in both Switzerland and UK Initiated NICE endorsement process Japan Europe/UK
Pipeline and R&D Update Peter Lichtlen, MD, PhDSenior Medical Officer and Vice President, European Operations
Development of new liquid dosage formSome patients cannot swallow gel capsPediatric Geriatric100% of development costs to be reimbursed by TakedaInitiate P3 pediatric trials in Q3 2013Pediatric functional constipation indicationTakeda to fund significant amount of developmental costs AMITIZA
Other Placeholder: Oral mucositis is a severely painful inflammation of the oral cavity 100% incidence rate in certain cancersUnmet medical needP1 trial in healthy volunteers initiatedNew oral spray formulationExpect to complete P1 in Q2 2013 SPI-8811 (cobiprostone) for Oral Mucositis See Reference 7; photos from Silverman. Diagnosis and management of oral mucositis. J Support Oncol 2007; 5 (2 Suppl 1):13-21.
Other Placeholder: LSS caused by degenerative change in lumbar spine; very common disease observed in growing aged populationUnmet medical needSPI-017 (IV) P2 trial and SPI-3608 (oral) P1 trial ongoing; expect to conclude in Q4 SPI-017 and SPI-3608 for Lumbar Spinal Stenosis Source: Photos from American Academy of Orthopaedic Surgeons website: www.orthoinfo.aaos.org
Japan Science and Technology Agency to provide RTU with the majority of funding for P3 clinical developmental costsCo-developing with RTURetinitis pigmentosa (RP) begins with degeneration of rods, followed by progressive and irreversible death of cones leading to blindnessCurrently no drugs or treatments approved for RPSucampo received orphan drug designation for unoprostone isopropyl in US Unoprostone Isopropyl for Retinitis Pigmentosa Source: Photos from Foundation Fighting Blindness website: www.blindness.org
Financial Performance Cary J. ClaiborneChief Financial Officer
Q4 and FY 2012 Financial Highlights +49% +145% Q4-11 Q4-12 FY-11 FY-12 Total Revenues $M +469% Q4-11 Q4-12 +133% FY-11 FY-12 R&D Revenue $14.2 $34.9 $54.8 $2.7 $15.1 $9.2 $21.5 $81.5
Q4 and FY 2012 Financial Highlights $M +20% +31% Q4-11 Q4-12 FY-11 FY-12 AMITIZA Net Sales $226.4 $271.9 +31% +22% Q4-11 Q4-12 Product Royalty Revenue FY-11 FY-12 $56.8 $74.6 $10.8 $14.2 $41.5 $50.7
$M except EPS Q4 2011 Q4 2012 FY 2011 FY 2012 Operating Income $3.6 $13.0 ($17.7) $8.3 Net Income $2.7 $13.5 ($17.3) $4.8 EPS $0.06 $0.32 ($0.41) $0.12 R&D $7.7 $7.1 $33.5 $21.3 G&A $12.0 $7.6 $41.3 $30.2 Selling & Marketing $2.1 $4.2 $8.8 $18.7 19
Cash position $91.4 million as of December 31, 2012$15 million milestone payment received from Abbott Japan Repurchased 146,908 shares during quarterRecently raised authorized amount to $5 millionOne class of common stockOperating cash flow of $17.2 million for Q4 and $12 million for FY 2012 Q4 and FY 2012 Financial Highlights
Closing Remarks Ryuji Ueno, MD, PhD, PhDChairman, Chief Executive Officer, Chief Scientific Officer, and Co-founder
2013 Key Value Drivers Completed In Process Obtain approval of OIC sNDA: Q2 2013$10M milestone payment upon first OIC saleAchieve FPFV in Pediatric P3 trial by Q3 2013 US AMITIZA Grow sales in Japan in 2013 Japan Submit for regulatory approval of OIC in Switzerland and UK by Q1 2013Seek NICE endorsement for CIC and OIC and make AMITIZA available in UKBegin active marketing in Switzerland for CIC Use MHRA approval to seek expansion of CIC indication to other EU markets via MRP EU RESCULA Launch: Q1 2013 US Pipeline Complete oral mucositis P1A trial: Q2 2013 Initiate P1B/2A trial in oral mucositis: Q4 2013 Cobiprostone Complete spinal stenosis P2A trial: Q4 2013 SPI-017
Sucampo Pharmaceuticals, Inc.
References American Academy of Ophthalmology Glaucoma Panel. Preferred Practice Pattern® guideline: Primary open-angle glaucoma. 2010Kass MA et al. Arch Ophthalmol. The Ocular Hypertension Treatment Study: a randomized trial determines that topical ocular hypotensive medication delays or prevents the onset of primary open-angle glaucoma. 2002 Jun;120(6):701-13; discussion 829-30.IMS HealthVerispan PDDAPhysician Interviews ClearView AnalysisTrotti A et al. Radiother Oncol. Mucositis incidence, severity and associated outcomes in patients with head and neck cancer receiving radiotherapy with or without chemotherapy: a systematic literature review. 2003 Mar;66(3):253-62.
Exhibit 99.3
P R E S E N T A T I O N
Operator
Good afternoon and welcome to Sucampo's
fourth-quarter and full-year 2012 financial results and operating
highlights conference call. For opening remarks and introductions, I
would like to turn the call over to Silvia Taylor, Sucampo's Senior Vice
President of Investor Relations, Public Relations and Corporate
Communications. Please proceed.
Silvia Taylor - Sucampo
Pharmaceuticals Inc - SVP, IR
Thank you, operator, and good
afternoon, everyone. Thank you for joining us today. The earnings
release and its attachments announcing Sucampo's fourth-quarter and
full-year 2012 financial and operational highlights is being distributed
this afternoon. For those of you who have not yet seen it, you will find
it posted in For Investor section of our website at www.sucampo.com
shortly. We also plan to file our 10-K shortly and once filed, a link to
that document will also be posted on our website. Now, please turn to
slide 3 of our presentation deck. Our agenda today is as follows. Dr.
Ryuji Ueno, the Chairman of the Board, Chief Executive Officer and Chief
Scientific Officer will provide an overview of the quarter and
highlights for the year. Stanley Miele, Senior Vice President of Sales
and Marketing and President of Sucampo Pharma America will review
development in the US for AMITIZA and RESCULA. Andrew Smith, Vice
President of Operations and Finance will review AMITIZA development in
Japan and Europe. Dr. Peter Lichtlen, Senior Medical Officer and Vice
President of European Operations will review our pipeline activity,
followed by Cary Claiborne, Sucampo's Chief Financial Officer, who will
review the financials. Finally, Dr. Ueno will provide closing comments
just ahead of the Q&A portion of the call. Additional members of
Sucampo's team are present and available to answer your questions then.
Before we begin, on slide 4, please note that various remarks management
makes on this conference call and the information contained in today's
earnings release are as of March 13, 2012. The Company assumes no
obligation to update forward-looking statements contained in this
conference call earnings release or the attachments as a result of new
information or future events or developments. This conference call,
earnings release, and the attachments contain forward-looking
information about the Company's future operating and financial
performance, business plans and prospects, inline products and product
candidates and share repurchase plans to that involve substantial risks
and uncertainties. Please refer to the forward-looking statement and the
10-K found on our website for additional risk factors affecting our
forward-looking statements.
Now, I will turn the call over to Dr.
Ueno. Dr. Ueno, please go ahead.
Dr. Ryuji Ueno - Sucampo
Pharmaceuticals Inc - Chairman of the Board, CEO & Chief Scientific
Officer Thank you, Sylvia. Hello, everyone. Thank you for joining our
conference call today. Please turn the slide. In the fourth quarter of
2012, we continued to fulfill our mission of bringing prostone-based
medicines to patients around the world. 2012 was a year of tremendous
achievement for Sucampo as we reached several important milestones for
both our AMITIZA and RESCULA franchise. With AMITIZA approval and
launches in Japan and the UK, this year we will be recognizing revenue
on three continents. Our pipeline is also continuing to progress, and
with two new prostones progressing into the clinic, we now have a total
of five prostone-based compounds in clinical development. We're also
eagerly anticipating the late April PDUFA date for AMITIZA for
opioid-induced constipation (technical difficulty) of its kind. In the
United States, in December, the FDA approved our sNDA for RESCULA
unoprostone isopropryl for the lowering of interocular pressure in
patients with open angle glaucoma for ocular hypertension. Open angle
glaucoma is the most common form of glaucoma, and ocular hypertension
affects millions more in the United States alone. RESCULA is the first
BK channel activator approved for this indication. RESCULA's strength is
its safety and tolerability profile. As you heard during our RESCULA
update call last month, Sucampo has begun active commercialization of
the product, and it is now available in pharmacies across the US. We are
pleased to say that the early response to the RESCULA launch has been
quite positive, and we expect to carry this momentum through the
remainder of 2013. Additionally, early reports from the [ocular] market
are that it is favorable to receiving a product that has a different and
unique mechanism of action. Turning now to AMITIZA, as Stan Miele will
expand upon later, we've experienced solid growth and expansion in the
quarter and the year in the United States, even in the presence of the
competitive launch at the end of 2012. I am also pleased to let you know
that, in December, we received a $15 million milestone payment from
Abbott Japan, triggered by the first commercial sale of AMITIZA in
Japan, the second largest pharmaceutical market in the world. AMITIZA is
the first prescription medicine ever available in Japan for chronic
constipation, and it was launched by Abbott Japan to primary care and
specialist physicians on November 22, 2012. Fourth-quarter sales in
Japan were double our initial expectations. We are particularly proud of
the fact that this is the first time that Japan has ever approved a drug
for chronic constipation and that patients now have a treatment option
for this condition. In the United States, AMITIZA continues to
demonstrate strong dollar sales growth as reported to us by our partner.
AMITIZA year-over-year net sales during the fourth quarter grew by 31.3%
to $74.6 million. As we look at monthly data, we have continued to see
solid growth with January 2013 being our second highest month of AMITIZA
net sales ever. Also in the United States, we received supplemental
approval of AMITIZA from the FDA that removed pregnancy warning and
precautions from the label and clarified the information regarding the
use of AMITIZA by pregnant and/or nursing women. We believe this will
help physicians and women of child-bearing age who are suffering from
OIC or CIC to better evaluate the risk benefit profile of AMITIZA and it
will provide a competitive advantage for the product in the market. The
supplemental approval also added details to the mechanism of the action
section of the label which highlight AMITIZA's ability to reduce
intestinal permeability via the restoration of tight junction protein
complexes. We believe this is important to further clarify understanding
of how AMITIZA may work for clinicians evaluating the treatment of
patients with IBSC since the increase in permeability and distraction of
tight junctions is thought to be one of the major causes of IBSC. The
PDUFA date for the opiod-induced constipation indications remains late
April 2013. We are pleased with how the review is proceeding, and we
continue to maintain ongoing discussion with the FDA on our filing.
Following the first sale for this indication, Sucampo will earn $10
million-milestone payment from Takeda per the terms of our contract with
them. In Switzerland, we reached an agreement with authorities for the
reimbursement price for AMITIZA for CIC, and we have begun to build the
sales organization in Switzerland. Another achievement for AMITIZA in
the second half of 2012 was its approval in the United Kingdom for the
treatment of CIC. Our priority now is to achieve National Institute for
Clinical Excellence, in short, nice endorsements so that we can actively
market AMITIZA in the United Kingdom, and we have already had our first
meeting with NICE. We have begun commercialization efforts while we
await NICE's endorsement.
In addition to the success we achieved with AMITIZA and RESCULA, we also
continue to make progress in our budding pipeline of prostone-based
candidates. As you may recall, we discussed our pipeline priorities at
our September 12 analyst day, our phase I trial of an oral formulation
of SPI-8811, or Cobiprostone, for the prevention and treatment of oral
mucositis remains on track. We expect to complete the trial in the
second quarter of 2013. As you will hear more during this call,
development of oral mucositis is a common severe side effect of cancer
treatment. This is an area of our met medical need because there are no
prescription drugs available for prevention or treatment of oral
mucositis. Progress with SPI-017 and SPI-3608 for the management of CVLE
symptomatic lumbar spinal stenosis continues. Lumbar spinal stenosis is
caused by a degenerative change in the lumbar spine and is a common
disease among the aging population. We initiated our phase IIA trial for
SPI-017, the IV formulation of the product, in the first quarter of
2013. We also initiated a phase I program for SPI-3608, the oral version
of the product in the fourth quarter of 2012. We remain on track to
report on the progress of both trials in the fourth quarter of 2013. We
are very pleased that we now have two products in phase III clinical
development. As we will discuss in that call, later this year we will
begin a phase III program for a pediatric indication for AMITIZA. And
after a successful phase II trial for unoprostone isopropyl in retinitis
pigmentosa, unoprostone isopropryl will move into phase III clinical
development and that a guidance of our development partner, R-Tech Ueno
Limited. As we reported earlier this year, the Japanese government has
adopted unoprostone isopropryl into a technology transfer program which
will provide funding for R-Tech Ueno's phase III development cost in
retinitis pigmentosa. Unoprostone isopropryl's mechanizable action, BK
channel activation, has demonstrated strong evidence of the protective
effect of unoprostone on the retina in both in vitro and in vivo
non-clinical models. We are very encouraged by the successful phase II
clinical data from Japan where a significant positive differences we are
seeing on the evaluation of visual sensitivity when comparing
unoprostone isopropryl versus placebo treatment of mid to late stage
retinitis pigmentosa patients. Sucampo is, quote, developing unoprostone
isopropyl with R-Tech Ueno, and we may proceed with the development
program for retinitis pigmentosa in the future, assuming the phase III
Japanese program is successful. I am also pleased with the appointment
of our two newest board members, Barbara Munder and Maureen O'Connell.
They are both highly qualified and bring a breath of experience in
public companies to Sucampo board that we think will be very valuable as
we move forward. I am very pleased with the progress we made in 2012. It
was truly a transformational year for Sucampo, and I am confident that
we will successfully execute against our plans for 2013 as we grow
AMITIZA and RESCULA and advance our product pipeline portfolio. I will
now turn the call over to Stan Miele who will give a commercial update
regarding the launch of RESCULA in the United States and the continued
commercialization of AMITIZA in the US. Stan?
Stanley Miele -
Sucampo Pharmaceuticals Inc - SVP, Sales & Marketing & President of
Sucampo Pharma America Thank you, Dr. Ueno. Good afternoon. It's a
pleasure to speak with everyone. I am very excited to speak with you
about two key areas. First, Sucampo's launch of RESCULA in the United
States, where we are ahead of schedule on many fronts, and second, the
update on AMITIZA as we evaluate an additional entrant into the market.
Please turn to slide 8. Our sNDA for RESCULA for the lowering of
intraocular pressure, or IOP, in patients with open angle glaucoma or
ocular hypertension was approved in December, and we moved quickly to
launch the product in the first quarter of this year. In February, we
announced that RESCULA was available in pharmacies across the US. Dr.
Ueno mentioned, open angle glaucoma is the most common form of glaucoma
and currently affects in excess of 2 million people in the US. It is
estimated that ocular hypertension also affects an additional 3 million
to 6 million patients in the US. This results in approximately 30
million prescriptions per year in the United States. RESCULA provides an
alternate route for intraocular pressure, or IOP reduction in the
treatment of these conditions. Its mechanism of action affects the BK
channels, which increases the outflow of aqueous humor through the
trabecular meshwork. As a result, there have been over 6.4 million
dispensed bottles of RESCULA on the global basis, primarily in the
Japanese market. We expect to build upon the Japanese experience and
accelerate patient utilization in the US. We are positioning RESCULA as
an appropriate choice for eye specialists who are trying to balance
efficacy with the management of side effects, particularly the 5% to 10%
of patients who cannot tolerate a prostaglandin analogue due to ocular
side affects. We are excited to have an 11% share of voice through our
40 Sucampo sales representatives. The first 12 months of launch, we
expect to have approximately 60,000 face-to-face interactions in which
we will reach prescribers representing 80% of the market. In fact, we've
made over 5,000 calls since early February and have provided over 50,000
samples to eye specialists. As a reminder, this market is highly sample
sensitive; it is typical for patients to receive a 30-day sample to
assess both efficacy and safety before a prescription is written. The
early feedback is positive, and many clinicians have begun using RESCULA
samples with some prescribing the medicine which should be reflected in
the IMS data over the next several months. Achieving managed care
coverage of RESCULA is also a high priority. So far we have had 47
face-to-face meetings with the plans and pharmacy benefit managers that
constitutes 80% of the covered lives. We are pleased that managed care
is seeing the value of RESCULA, and many of the top plans are providing
interim coverage of the product while they await making a final decision
through their P&T committees. In summary, we are pleased by the
favorable reception to RESCULA so far and will continue to work hard
toward the goal of minimizing any potential obstacles for patients and
physicians and ensuring a positive experience with RESCULA. I look
forward to continuing to update on the RESCULA launch throughout the
year. Now, turning to AMITIZA in the US, I would like to first give a
brief review of the recent AMITIZA prescription trends and how we are
pleased with what we are seeing thus far. Please refer to slide 9. If we
look at reported IMS monthly prescription data, January 2013 was the
second highest month of total prescriptions ever, up 9.7% from January
2012. In the fourth quarter of 2012, both TRX and NRX growth over the
same period last year were up 6%. We believe that based on the revised
AMITIZA label removing the negative pregnancy test, along with the
updated mechanism of action highlighting the reduction in intestinal
permeability, this will further differentiate AMITIZA and be a catalyst
for continued growth, regardless of new competition. As we reported
earlier today, AMITIZA net sales have increased during the quarter by
31.3% to $74.6 million as reported to us by our partner, Takeda. This
growth in net sales was primarily due to both volume and price
increases. We expect this trajectory of strong growth to continue, given
AMITIZA's well-tolerated safety profile and the desire by prescribers,
particularly primary care physicians, to prescribed drugs that have a
established track record of safety over several years. Since its launch
almost seven years ago, AMITIZA has been prescribed more than 7 million
times. Toward the end of 2012, we saw the addition of the new entrant
into the marketplace, which will continue to bring a heightened level of
awareness of the CIC and IBSC diseases and help bring new patients into
the market. As this market continues to grow, we expect AMITIZA to
capture an increasing number of patients and market share. As stated
above, January 2013 was the second highest month of total prescriptions
in AMITIZA's history. Based on some early data points, AMITIZA has grown
the business in the face of a competitive launch. Our position is to,
again, focus on our product strengths and also exploit some of the
strong managed care gains over the past year along with our label
revisions. Turning to our potential new indication for AMITIZA, our
PDUFA date for the opioid-induced constipation indication remains late
April. We are pleased with how the review is proceeding and we continue
to maintain ongoing discussions with the FDA on our filing. We still
strongly believe that the priority review demonstrates a significant
unmet medical need for the condition of OIC and we believe AMITIZA, when
approved, will be well-positioned by our partner to take advantage of
this unmet medical need. In the US, there are over 200 million opioid
prescriptions written annually, and our research shows that moderate to
severe OIC affects conservatively between 2 million to 2.5 million
non-cancer chronic pain patients in the US. OIC is an area of high unmet
medical need, and patients are suffering with few, if any, viable
treatment options. The scientific literature states that anywhere
between 40% to 80% of chronic opioid users will experience constipation
as a side affect, and that when it occurs, the constipation is likely to
be moderate to severe. So severe, in fact, that some patients choose to
live in pain and discontinue their opioid treatment, rather than suffer
the constipation that ensues. In addition, we know that primary care
physicians who prescribe the majority of these patients are also looking
for a medicine indicated to treat their patients with OIC. We are
working with Takeda to prepare for the launch of the new indication when
it is approved. Also, upon the first sale of AMITIZA for this
indication, we will receive a $10 million milestone payment from our US
alliance partner. I would like to now turn the call over to Andrew
Smith, Vice President of Operations and Finance to provide comments on
the AMITIZA commercialization efforts in Japan and Europe. Andrew?
Andrew Smith - Sucampo Pharmaceuticals Inc - VP, Operations &
Finance
Thank you, Stan, and good afternoon, everyone. Welcome to the
call. Please refer to slide 10. We're very pleased that AMITIZA was
approved in Japan during the second quarter of 2012 for the treatment of
chronic constipation and our partner, Abbott Japan, was successful in
carrying out a comprehensive launch of AMITIZA beginning in late
November, 2012. The first commercial sale of AMITIZA resulted in a $15
million milestone payment to us from Abbott Japan in December. We are
particularly proud of the fact that this is the first ever prescription
medicine approved for chronic constipation in Japan. Abbott Japan
deployed an extensive sales and marketing effort designed to introduce
AMITIZA to the primary care and specialty physician audiences.
Importantly, we have received guidance on pricing reimbursement for
AMITIZA in Japan. This is important, because it will allow more patients
to have access to the product. The launch continues to progress
extremely well. Fourth-quarter product sales of $5 million, exceeding
Abbott Japan's initial projections. In addition, Abbott's detailing
efforts for AMITIZA rank in the top 20 in GP segment of all
pharmaceutical detailed products in Japan early into its sales efforts
for the product. We are pleased that there is a now high level of
product awareness and excitement among Japanese physicians about
AMITIZA. So, we're pleased with these commercialization efforts and
encouraging early results by our Japanese partner and look forward to
strong sales of AMITIZA in Japan in the coming months. Turning now to
AMITIZA in Europe, as mentioned in our last earnings call, we received
the reimbursement price for AMITIZA in Switzerland on December 1, 2012,
and we have begun to build the sales organization in Switzerland. As Dr.
Ueno mentioned at the start of the call, we are making progress on our
plans to launch AMITIZA in the UK. We have initiated the NICE
endorsement process for both CIC and OIC indications, which we believe
is one of the keys to gaining widespread adoption of AMITIZA in the UK
and gain an established prescriber base. In addition, as we have
previously disclosed, we are using the MHRA approval to seek expansion
of AMITIZA's CIC indication to other European markets via the mutual
recognition procedure. And finally, we have completed our filings for
the OIC indication in Switzerland and the UK this quarter. With that, I
would like to turn the call over to Peter Lichtlen to discuss our
pipeline. Peter?
Peter Lichtlen - Sucampo Pharmaceuticals
Inc - Senior Medical Officer & VP of European Operations
Thank
you, Andrew. Good afternoon, everyone, it's a pleasure to speak with
you. We have had a busy year in R&D this year, and we have a lot to talk
about, so let's go to it. Please refer to slide 12. We continue to make
progress on AMITIZA, including the development of a new liquid dosage
form of the product. This liquid dosage form is significant because it
can allow us to provide AMITIZA to new patient populations who can not
swallow the current gel cap, namely pediatric and many geriatric
patients. Our commercial team will be working with our partners to
properly position this new dosage forum. Additionally, 100% of the
development costs for the new liquid dosage form will be reimbursed by
Takeda per the terms of our contract with them. We are pleased to let
you know that we continue to make progress toward the pediatric
functional constipation indications, and we plan to initiate a phase III
program in the US, Canada, and Europe in the third quarter of this year.
Importantly, Takeda will fund the majority of the development costs for
the pediatric indication. Again, per our contract. Now please turn to
slide 13. Our progress continues on SPI-8811, or Cobiprostone, for the
prevention and treatment of oral mucositis. Development of oral
mucositis, a severely painful inflammation of the oral cavity, is
commonly associated with cancer treatments such as radiation and
chemotherapy. Currently, no truly effective treatment option exists,
making this an area of high unmet medical needs. Additionally, oral
mucositis can have incident rates of approaching 100% in certain cancer
types. The effect of oral mucositis can be devastating for cancer
patients, leading to dehydration, insertion of feeding tubes and
sometimes even discontinuation of cancer therapy in the more extreme
cases. We have developed a new spray formulation of SPI-8811 for local
use for this indication, and we are currently testing this compound in a
phase IA clinical trial. This trial allows us to fulfill our corporate
mission of using a nominative research and development and our
proprietary prostone technology to meet the unmet medical needs of
patients. We continue to expect to complete phase IA of this trial in
the second quarter of 2013 and plan to initiate a phase IB/IIA clinical
trial in the fourth quarter of this year. On slide 14, our progress on
the phase II trial of SPI-017, an IV compound for the management of
severely symptomatic lumbar spinal stenosis continues, and does our
phase I trial of SPI-3608, an oral treatment modality for mild to
moderate patients with the same disease. We plan to conclude these
trials in the fourth quarter of this year. These trials are being
conducted in Japan where the only currently approved medication of LSS
is an oral PGE1 analog. We know that prostaglandins are associated with
poor systemic safety and require careful and fractionated dosing. In the
United States and Europe, no medications are approved for this specific
indication. Again, this is clearly an area of unmet medical need.
Finally, life cycle management unoprostone isopropryl is a priority for
us. As Dr. Ueno briefly mentioned earlier, the Japan science and
technology agency has agreed to provide the majority of the funding for
R-Tech Ueno's phase III clinical development costs for unoprostone
isopropryl for retinitis pigmentosa under the adaptable and seamless
technology transfer program. Sucampo is co-developing unoprostone
isopropryl with R-Tech Ueno. This program provides a participating
institution with a total R&D funding of up to $2 billion yen,
approximately $22 million US for up to seven years. If the development
is successful, the participating institution repays the total amount of
the provided funding by paying royalties based on product sales. If the
development is not successful, the participating institution repays 10%
of the provided funding with no interest payments due. As part of our
agreement for unoprostone isopropryl with RTU, Sucampo will receive the
data from this Japanese clinical development program which, if
successful, will play a significant role in development efforts for
retinitis pigmentosa for unoprostone isopropryl in the United States and
Europe. Retinitis pigmentosa is a group of retinal degenerative diseases
characterized by night blindness, the progressive loss of peripheral
vision and, eventually, loss of central vision, leading to blindness. As
retinitis pigmentosa progresses, daily life becomes increasingly more
difficult. There are currently no drugs approved for the treatment of
RP. Sucampo receives an orphan drug status from the FDA for the
treatment of retinitis pigmentosa in 2010. We will seek orphan drug
status in the EU as well this year. With that, I look forward to
answering your questions at the end of this call and now turn it over to
Cary Claiborne to provide our financial update. Cary?
Cary Claiborne - Sucampo Pharmaceuticals Inc - CFO
Thank you,
Peter. Good afternoon, everyone. I would like to review the financial
highlights for the quarter and the full year with you. I will start with
slide 17. Total revenue for the fourth quarter of 2012 was $34.9 million
compared to $14.2 million in the fourth quarter of 2011, a growth rate
of 145%. Total revenue for the full-year 2012 was $81.5 million compared
to $54.8 million in the prior year, a growth rate of 49%. I'll cover the
drivers of the year-over-year increase in a few minutes. R&D revenue the
fourth quarter of 2012 was $15.1 million compared to $2.7 million during
last year's fourth quarter. For the full-year 2012, R&D revenue was
$21.5 million compared to $9.2 million in the prier year. The increase
in R&D revenue was primarily due to the receipt of the $15
million-milestone payment from Abbott Japan, partially offset by lower
activity associated with the completion of our phase III OIC trial for
AMITIZA in the US. Now, please move to slide 18. Net sales of AMITIZA in
the US, which are reported to Sucampo by our alliance partner Takeda,
increased 31% to $74.6 million in the fourth quarter of 2012, compared
to $56.8 million in last year's fourth quarter. Net sales of AMITIZA
increased 20% to $271.9 million for the full year of 2012, compared to
$226.4 million in the prior year. As reported to us by Takeda, for both
periods, the increase in AMITIZA US net sales was primarily due to both
volume and price increase. Product royalty revenue for the fourth
quarter of 2012 was $14.2 million, an increase of $3.4 million, or 31%
from $10.8 million in last year's fourth quarter. Product royalty
revenue for the full year 2012 was $50.7 million, an increase of $9.2
million, or 22% compared to $41.5 million in the prior year. As Takeda
reported, the increase was primarily due to higher price and volume of
AMITIZA net sales in the US. As I've mentioned in some of our recent
investor conferences, our revenues under the agreement with Abbott are
not royalties but are actual sales of AMITIZA products to Abbott Japan
under our license and commercialization agreement. You will see this
reflected on our P&L as products sales revenue and cost of goods sold.
Product sales revenue and costs of goods sold also include sales in
AMITIZA in Europe, and, in future quarters, this will be where we report
RESCULA sales. In 2012, we recognized $5 million of product sales
revenue and $3 million of cost of goods sold compared to nil for both in
2011. The majority of the sales were related to our sales of AMITIZA to
Abbott, Japan. Please move to slide 19 which features additional
financial highlights. Let's take a look at income next. For the fourth
quarter of 2012, income from operations was a profit of $13 million, an
increase of $9.4 million compared to a profit from operations of $3.6
million in the fourth quarter of 2011. For the full-year of 2012, income
from operations was a profit of $8.3 million compared to a loss from
operations of $17.7 million in the prior year. For the fourth quarter of
2012, Sucampo reported net income of $13.5 million, or $0.32 per share,
an increase of $10.8 million compared to a net income of $2.7 million,
or $0.06 per share in last year's fourth quarter. The fourth quarter of
2012 included a foreign exchange gain of $0.9 million compared to a gain
of $14,000 in last year's fourth quarter. For the full-year 2012,
Sucampo reported a net income of $4.8 million, or $0.12 per share
compared to a net loss of $17.3 million, or $0.41 per share in the prior
year. Now, taking a look at operating expenses, R&D expenses were $7.1
million in the fourth quarter of 2012 compared to $7.7 million for the
same period last year. For the full-year 2012, R&D expenses were $21.3
million compared to $33.5 million in the prior year. For both periods,
the decrease was primarily due to higher expenses in 2011 associated
with the completion of the phase III OIC trial for AMITIZA. G&A expenses
were $7.6 million in the fourth quarter of 2012 compared to $12 million
in last year's fourth quarter, a decrease of $4.4 million, or 37%. G&A
expenses were $30.2 million for the full-year 2012 compared to $41.3
million in the prior year, a decrease of $11.1 million, or 27%. For both
periods, the decrease in G&A expense is primarily due to lower legal,
consulting and other professional expenses that were related to 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 $4.2 million in the
fourth quarter compared to $2.1 million in last year's fourth quarter.
For the full-year 2012, selling and marketing expenses were $18.7
million compared to $8.8 million in the prior years. For both periods,
the increase in selling and marketing expenses relates primarily to some
non-recurring precommercialization planning activities for AMITIZA and
the commercialization and launch costs for RESCULA. And finally, as it
relates to operating expense, in 2011, Sucampo reported income of $11.1
million from the favorable settlement of a legal claim related to a
dispute with Covance, a CRO that performed clinical trials for the OIC
indication. The amount represented receipt of $10 million in cash and
cancellation of outstanding payables of $1.1 million and was reported as
a reduction to 2011 operating expenses. This was on a separate line on
our income statement. There were no corresponding amounts in 2012. We
think this is notable because when you exclude the one-time settlement,
our year-over-year decrease in total operating expense is actually $13.4
million. Let's move on to the balance sheet. Please refer to slide 20.
As of December 31, 2012, cash, cash equivalents, restricted cash and
investments were $91.4 million compared to $93.4 million at December 31,
2011. As was mentioned earlier on the call, upon Abbott Japan's first
commercial sale of AMITIZA in Japan, Sucampo received the milestone
payment of $15 million. That was received in the fourth quarter of 2012.
As we stated during our third quarter earnings call, on November 2,
2012, our board authorized an increase in the amount of our common stock
repurchase program from the previously announced $2 million, up to an
aggregate of $5 million. During the fourth quarter, we purchased 146,908
shares at a cost of $721,487. For the full year of 2012, we purchased
270,043 shares at a cost of $1.28 million. I'm also very pleased to
report the Sucampo generated a positive operating cash flow of $17.2
million in the fourth quarter and $12 million for the full-year of 2012.
The slight decrease in our cash position, as well as a positive cash
flow for the year, reflects for the improvement in year-over-year
operating results I just mentioned, as well as our continued focus on
working capital management. Thank you for your attention. I look forward
to your questions at the end of this call Now, I will turn the call back
to Dr. Ueno to summarize the value drivers achieved in 2012 and to
discuss this year's value drivers. Dr. Ueno?
Dr. Ryuji Ueno -
Sucampo Pharmaceuticals Inc - Chairman of the Board, CEO & Chief
Scientific Officer
Thank you, Cary. Please turn your attention to
slide 22. I am proud of the fact that we met all of our key value
drivers for 2012. We are excited as we look forward to a productive
2013. As we look to this year, we have set the following key value
drivers for the year that we believe will increase shareholder value.
These include, for AMITIZA, receiving approval of AMITIZA's sNDA for OIC
in the second quarter of 2013. Upon the first sale of AMITIZA for OIC,
Sucampo will receive $10 million milestone payment. Achieving first
patient, first visit, in our pediatric functional constipation phase III
trial for AMITIZA by the third quarter of this year. Growth of AMITIZA
sales in Japan. Permissions for regulatory approval of AMITIZA in the
treatment in OIC in Switzerland and in the UK by the first quarter of
2013. I am pleased that we have just achieved this value driver today.
Seeking nice endorsements for both CIC and OIC and making AMITIZA
available in the UK with reimbursement by some local budget holders.
Beginning active marketing in Switzerland for CIC. Use of MHRA approval
to seek expansion of AMITIZA's CIC indication to other European markets
via the mutual recognition procedure. For RESCULA, the successful
rollout of RESCULA in the US. For the pipeline, completion of our oral
mucositis phase IA trial for cobiprostone in the second quarter of 2013,
and initiation of our phase IB/IIA trial in the fourth quarter of 2013.
And finally, completion of our spinal stenosis phase IIA trial for SPI-
017 in the fourth quarter of 2013. As can you see, we have a busy year
ahead of us. I thank you for your continued support as we move forward
on these key priorities and work to increase shareholder value. We are
now ready to start the Q&A portion of the call. Operator, please open up
the lines for questions.
Q U E S T I O N S A N D A N S W E R S
Operator
(Operator
Instructions)
Please stand by for your first question. Your first
question comes from the line of Irina Rivkind with Cantor Fitzgerald.
You may proceed.
Irina Rivkind - Cantor Fizgerald -
AnalystHey, guys, thanks for the questions. Very ice quarter. I wanted
to start by asking about the liquid AMITIZA dosage form. Can you walk us
briefly through the plan for development of this form and its launch?
Thanks.
Taryn Joswick - Sucampo Pharmaceuticals Inc - VP
Clinical Development
So, I -- this is Taryn Joswick, I am the VP of
clinical development, I will speak a little bit about the development
plans, and then I'm going to pass it over to Stan for the discussion
about the market. So, the liquid formulation, we have been working on it
for some time now, and we're currently in the clinical study phase of
evaluating the liquid formulation and preparing basically the data
package that would constitute the dosi that we'll file with the FDA for
the new formulation to be added to the labeling. And Stan, I will let
you speak with –
Stanley Miele - Sucampo
Pharmaceuticals Inc - SVP, Sales & Marketing & President of Sucampo
Pharma America
Right, as it relates to the commercialization side of
this, we have certainly been focused on a liquid formulation for quite a
while. I don't want to confuse things. We're still a bit of a ways off
from actually bringing this to market, but we're focused on this from
not only a pediatric perspective but also a geriatric or certain senior
care populations as well. We have the ability to look at various
concentrations at this point in time, though, are still focused on the
existing CIC concentration, which is the 24 microgram. And -- but as we
look at the pediatric side of things, we would -- we're evaluating other
dosage concentrations for that. But on the senior care side, we would be
focused on the 24 microgram as a liquid formulation.
Irina
Rivkind - Cantor Fizgerald - Analyst
Okay, For the $5 million in
AMITIZA sales to Abbott in Japan, does that reflect a load-in of
inventory that's going to be worked down later, or is it more reflective
of demand?
Cary Claiborne - Sucampo Pharmaceuticals Inc -
CFO
I think -- this is Cary, Irina. They is some loading of inventory
as they were ramping up to launch in the fourth quarter.
Irina
Rivkind - Cantor Fizgerald - Analyst
Okay, have you disclosed
AMITIZA pricing in Switzerland?
Cary Claiborne - Sucampo
Pharmaceuticals Inc - CFO
Have we disclosed that?
Taryn
Joswick - Sucampo Pharmaceuticals Inc - VP Clinical Development
Andrew,
can you take that question, please.
Andrew Smith - Sucampo
Pharmaceuticals Inc - VP, Operations & Finance
Sure. The AMITIZA
pricing in Switzerland is publicly available. It's 2 francs 59,
equivalent to about, $275.
Irina Rivkind - Cantor Fizgerald - Analyst
Is that per day or
per dose?
Andrew Smith - Sucampo Pharmaceuticals Inc - VP,
Operations & Finance
Per day.
Irina Rivkind - Cantor Fizgerald - Analyst
Okay. Thank you.
And I guess I will jump back in the queue and let someone else go.
Operator
Your
next question comes from the line of Tim Lynch with Stonepine Capital.
You may proceed.
Tim Lynch - Stonepine Capital - Analyst
Hi,
a lot of good stuff going on. The question about US AMITIZA sales,
thanks for the color on Q4 in January. How is February in terms of IMS
data in the face of competitive pressures?
Stanley Miele -
Sucampo Pharmaceuticals Inc - SVP, Sales & Marketing & President of
Sucampo Pharma America
We can look at some of the weekly data,
and we tend to look at weekly data, I don't want to say with skepticism,
because you have to look at consecutive weeks to see if you have a
pattern developing. We were down 0.1% versus the prior week when we
looked at the first week of February and then in subsequent weeks, we
were up over 8%. In general, we're still holding firm where we -- with
what our expectations are for February. I think it's -- when we look at
also new to brand prescriptions, there is an interesting phenomenon as
we begin to analyze that where Linzess has started to decline as we look
at those naive patients who are, in fact, entering the market. And we're
actually gaining a larger share for some of these now to the brand
patients entering into the market. So, I look at the first two months of
December and January when Linzess was on the market initially launching.
We were up over 6%, roughly 6.3% year-over-year. February weeklies,
we're certainly keeping a close eye on that. At this point in time, even
with new prescriptions, we feel confident that we're going to be able to
maintain and grow our share respectively.
Tim Lynch -
Stonepine Capital - Analyst
That's great. Do you think that is
attributed to maybe a lack of historical marketing for AMITIZA now with
the category getting more attention and perhaps Takeda putting more
prominence to it, that that is the dynamic going on? What do you
attribute that to, the strength and prescription trends?
Stanley
Miele - Sucampo Pharmaceuticals Inc - SVP, Sales & Marketing &
President of Sucampo Pharma America
We have noticing over, certainly
the last year, a revised effort post arbitration, but a lot of the
consistency relative to the marketing effort focusing on the safety,
focusing on the mechanism, Takeda buying into some of the targeting that
we had been challenging them on all along. But I think of late, it's
clearly -- I think we welcome the noise to the market. And the issue
will be who wins the battle of the new naive patients coming to the
market? Both of us want the market, both us and certainly Ironwood, to
increase, and we want the -- those patients that are naive. And what
we're pleased to see, again, if we take a look at the last -- since
January, there has been a consistent decline in the newer patients going
over to Linzess versus those that are actually coming over to AMITIZA. I
think it's a focused market effort by Takeda and the safety message that
is finally resonating with a lot of the primary care physicians as well
in addition to a strong managed care position that Takeda has within the
last 12 months done a very concentrated effort to put ourselves in a
position of strength with respect to both commercial lives and managed
care lives.
Tim Lynch - Stonepine Capital - Analyst
Great,
and one last question, then I'll hop back in the queue. With the loading
for Abbott -- sales to Abbott in Japan, and can you give us color and
end user demand, you said exceeded expectations, doubled your
expectations, more than Abbott's expectations. What percent of that $5
million can we view as perhaps initial stocking?
Taryn Joswick -
Sucampo Pharmaceuticals Inc - VP Clinical Development
Okay, Andrew,
do you want to take that question about Japan sales?
Andrew Smith - Sucampo Pharmaceuticals Inc - VP, Operations &
Finance
Sure.
Taryn Joswick - Sucampo Pharmaceuticals
Inc - VP Clinical Development
Thank you.
Andrew Smith -
Sucampo Pharmaceuticals Inc - VP, Operations & Finance
The
initial stocking -- the sales in Q4, the bulk of that was initial
stocking. Remember, the launch was really November 22. It's quite early
stages to see that. We are encouraged with the early signs of
performance and growth, as we said, but I think probably you will see
that in our next call.
Tim Lynch - Stonepine Capital - Analyst
Great. Thank you.
Operator
Your next question comes from the line of Christian
Glenline (sp) with Edison Investment Research. You may proceed.
Christian
Glennie - Edison Investment Research - Analyst
Hi, good
afternoon, just to followup on the Japan situation. Is that margin that
you have got there, that 40%. Is that -- would that be -- is that a
reasonable perspective, was that going to iron out over awhile?
Stanley
Miele - Sucampo Pharmaceuticals Inc - SVP, Sales & Marketing &
President of Sucampo Pharma America
That's rough order what you would
expect to see.
Christian Glennie - Edison Investment
Research - Analyst
Okay. Thank you. And then on Europe for AMITIZA,
can you talk a bit about the sort of the investments you're making there
in the UK and Switzerland, in terms of preparing to get that fully
commercial and/or considering local distribution partners and that sort
of thing.
Andrew Smith - Sucampo Pharmaceuticals Inc - VP,
Operations & Finance
Okay, it's quite early stages, as we've
said, in those markets in the UK and Switzerland. We're directly
marketing the product ourselves. Because it'sthe early stages,
particularly in the UK where we're going through the NICE endorsement
process and looking to have some demand with local budget holders were
put in place the appropriate level of coverage to cover that growth. But
it hasn't been significant to date.
Christian Glennie -
Edison Investment Research - Analyst
Okay. Thank you, and then one
final one on AMITIZA, US with the potential OIC approval. Aside from
obviously the milestones, it was a bit about implications in terms of
Takeda's commercialization of that opportunity there. Obviously the
addition of that's enabled and how you see that.
Stanley Miele -
Sucampo Pharmaceuticals Inc - SVP, Sales & Marketing & President of
Sucampo Pharma America
This is Stan. I think we -- I hope we
adequately covered that in the script, but I will say that based on the
early discussions and the ongoing discussions with Takeda and the
priority review, Takeda is committed to treating this as almost a
relaunch opportunity, so we, as in both Takeda and Sucampo, see this as
a great opportunity and are prepared to properly execute a relaunch with
this additional indication when approved. e Call
Christian Glennie - Edison Investment Research - Analyst
Okay.
Thank you.
Operator
You have a follow-up question from
the line of Irina Rivkind with Cantor Fitzgerald. You may proceed.
Irina Rivkind - Cantor Fizgerald - Analyst
Actually two
follow-up questions. Stan, I'm very interested to learn about your
methodology in figuring out how -- about the new patients to AMITIZA
versus new patients to Linzess. Can you elaborate on that a little bit
more?
Stanley Miele - Sucampo Pharmaceuticals Inc - SVP,
Sales & Marketing & President of Sucampo Pharma America
Yes.
This is actually something that you can actually get from when you start
looking at the IMS data, and we can have a separate followup phone call.
Irina
Rivkind - Cantor Fizgerald - Analyst
Yes.
Stanley Miele -
Sucampo Pharmaceuticals Inc - SVP, Sales & Marketing & President of
Sucampo Pharma America
Because you also go back historically as well,
looking at the last 12 months. But there is a formula and a methodology
that's used where you can look at the -- the only drawback is, for
example, if a patient was on, let's say they were on AMITIZA and then
they dropped AMITIZA and then three months later, they decided to go
back on another product, they would actually still show up as a naive
product. Or a naive patient, rather, but we can set up a call. I would
be glad to.
Irina Rivkind - Cantor Fizgerald - Analyst
Okay.
Stanley Miele - Sucampo Pharmaceuticals Inc - SVP, Sales &
Marketing & President of Sucampo Pharma America
Go through that
with you in a conversation.
Irina Rivkind - Cantor
Fizgerald - Analyst
Okay. And then the second one is about the OIC
market. You mentioned that there is 2.5 million moderate to severe
patients and I wanted to see if in your model assessment, are those
patients already taking prescription medications? Or do you view these
as being on OTC products that are going to enter the existing
constipation market once there is an approved indication? Thanks.
Stanley
Miele - Sucampo Pharmaceuticals Inc - SVP, Sales & Marketing &
President of Sucampo Pharma America
Right. So, this is through both
our qual and quantitative research, and the majority of those patients
are still taking over-the-counter products or Miralax, if required. So,
we feel very confident that, even though there are some patients at this
point in time taking AMITIZA for OIC, it's off-label, it's not formally
indicated. And there is a small percentage of our current utilization
that is for OIC; however, the majority of those moderate to severe
patients are not -- they're still taking over the counter products and
hen PRN laxatives on an as-needed basis. We're -- what we're trying to
do is focus on the moderate to severe because we believe strongly that
those are the ones that would gravitate towards an RX product versus
those that just have an occasional bout of constipation, and that is why
we've been a bit more conservative than others as it relates to market
size. But we still feel confident that the 2 million to 2.5 million are
the ones that in research clearly indicate they are looking for
something and they would welcome an RX product.
Irina Rivkind -
Cantor Fizgerald - Analyst
Do you have any estimates around how many
days they would use this product? Is it similar to your other AMITIZA
days used, or no?
Stanley Miele - Sucampo Pharmaceuticals
Inc - SVP, Sales & Marketing & President of Sucampo Pharma America
At
this point in time, it's still similar to that of what we're looking at
on the CIC side. And again, it's probably -- it's in the range from a
modeling standpoint, we're still using that 156 days, that is what we're
using internally.
Irina Rivkind - Cantor Fizgerald -
Analyst
Thanks very much.
Operator
You have a follow
up question coming from the line of Tim Lynch with Stonepine Capital.
You may proceed.
Tim Lynch - Stonepine Capital - Analyst
Thanks.
On RESCULA, I know I used to know this. The sales force was shifted from
focusing on institutional AMITIZA accounts to ophthalmology, if I
understand correctly. And you used to receive some form of reimbursement
from Takeda prior to that shift, and now they are all paid for in
houses. Is that correct?
Stanley Miele - Sucampo
Pharmaceuticals Inc - SVP, Sales & Marketing & President of Sucampo
Pharma America
Yes, Tim. That's correct.
Tim Lynch -
Stonepine Capital - Analyst
Okay. Okay. And with RESCULA, when do you
expect we will see some visibility on usage? I know this is a relaunch
and expectations are often low for a relaunch product. I know the
label's new, but what kind of color do you think we'll get from you and
when? Because it sounds like this will be grouped into your product
sales line on your income statement, so we may not have it broken out.
But in terms of script data, something to give us a sense of traction in
the marketplace.
Stanley Miele - Sucampo Pharmaceuticals
Inc - SVP, Sales & Marketing & President of Sucampo Pharma America
Right,
we're starting clearly with the early metrics of sampling, contacts,
details, et cetera, but you will begin to see script trends within the
IMS data. For all intents and purposes, we're not expecting things to
start even showing up until we get into the March timeframe. But I have
been fairly straightforward saying that due to the 30 days of sampling,
bringing patients back, we're not looking at this as an early
trajectory. When you see an acceleration, it's more in the latter part
of this year once you get a lot of the samples utilized and the
appropriate patients are identified, but you should be able to looking
at script trends as early as the coming weeks. But I would say that if
we really want to get a solid gauge of where we expect RESCULA to go
from a trajectory standpoint, it's the second half of this year where we
have the greater expectations of what we want to see with the lift from
a NRX and TRX perspective.
Cary Claiborne - Sucampo Pharmaceuticals Inc - CFO
Tim, this
is Cary, and even though you're right, on the P&L there won't be a
separate line item, we will talk to the RESCULA sales versus the AMITIZA
sales on our calls and in our investor meetings that we -- where we have
conferences.
Tim Lynch - Stonepine Capital - Analyst
Great,
and then last question, do you consider that sales force, now that it's
a more expensive piece of infrastructure, something that you may
leverage regarding business development and licensing products, things
like that? Is this a strategic infrastructure or cost that you plan to
look externally to potentially leverage?
Stanley Miele -
Sucampo Pharmaceuticals Inc - SVP, Sales & Marketing & President of
Sucampo Pharma America
Well, we're certainly always open and
continuing to evaluate business development opportunities. And I could
not agree with you more that from a cost effective standpoint, you
always want to have more than one product in the bag. And I think at
this point in time, we're focused on RESCULA, but with the assumptions
that we will be successful, then it certainly can parlay into some other
opportunities as well. And we are doing this in as judicious manner as
possible, And -- but we will -- we are certainly entertaining and
looking at other potential opportunities from a BD perspective.
Tim
Lynch - Stonepine Capital - Analyst
Great. Thank you.
Operator
Your
next question comes from the line of Marco Rodriguez with Stonegate
Securities. You may proceed.
Dan Trang - Stonegate
Securities - Analyst
Hi, everyone. This is Dan Trang actually sitting
in for Marco Rodriguez. Stan, can you provide some color in regards to
the sales force and how the launch of RESCULA, I believe it's the same
sales force from AMITIZA. Am I correct there?
Stanley Miele -
Sucampo Pharmaceuticals Inc - SVP, Sales & Marketing & President of
Sucampo Pharma America
Yes, sir. It's the same team they we had
before. They -- our sales team, the average yearly experience is about
9.5 years. They're very -- they're experienced, one-third of our reps
had prior opthalmic experience, and they spent a significant amount of
time profiling the targeted physicians even prior to launch. So, that is
why we believe at time of launch we have been extremely successful,
having access to the offices, having access to the key physicians, both
ophthalmologists and optometrists, and we're also supported by the
medical and scientific affairs team who did about three months worth of
prelaunch activity. So, we're very pleased with the access that our
team's been able to garner thus far.
Dan Trang - Stonegate
Securities - Analyst
Okay.
Operator
(Operator
Instructions) You have a follow-up question coming from the line of
Christian Gelnine (sp) with Edison Investment Research. You may proceed.
Christian
Glennie - Edison Investment Research - Analyst
Hi, thanks, a
couple on the financials. I know you don't give duly specific guidance
and such, but obviously looking at some of the key operating R&D and
selling and marketing, in terms of Q4 numbers, how we should be thinking
about that for 2013, any guidance you can provide.
Cary
Claiborne - Sucampo Pharmaceuticals Inc - CFO
I will give you
directionally. Selling and marketing, as you know, we're launching --
we've launched RESCULA, so we expect selling and marketing expenses to
increase in 2013 as we're launching RESCULA. R&D, as you heard, we're
going into a phase III trial for pediatric indication for AMITIZA, so
you would expect R&D to increase as well. But keep in mind that a
significant portion of that trial will be reimbursed by our partner,
Takeda, in the US. And the G&A, G&A, we don't anticipate significant
change year-over-year in G&A. We're continuing to focus on being
productivity within our staff functions, and we built that up in 2012 to
support the business growth.
Operator
You have a
follow-up question coming from the line of [Jason Aria] with [Jolt
Equities]. You may proceed.
Jason Aria - Jolt Equities - Analyst
Hey, first of all, very
nice quarter. Two questions, one for Stan, one for Cary. To pick up on
Mr. Lynch's question about adding additional products to the bag, I
assume, Stan, that you will probably wait to see how RESCULA launch
plays out, and if it's successful, you will add products to the bag, but
probably not prematurely.
Stanley Miele - Sucampo
Pharmaceuticals Inc - SVP, Sales & Marketing & President of Sucampo
Pharma America
That is correct.
Jason Aria - Jolt
Equities - Analyst
Great, I think that is very prudent. And Cary, you
had just talked about G&A being steady from the 2012 levels where there
was obviously a lot of legal expense in the first half of that, at
least. Would that not -- would it not be lower because that, thankfully,
comes off of the books?
Cary Claiborne - Sucampo
Pharmaceuticals Inc - CFO
Well, yes, I think you saw we announced a
little while ago about a generic lawsuit.
Jason Aria -
Jolt Equities - Analyst
Yes.
Cary Claiborne - Sucampo
Pharmaceuticals Inc - CFO
So, there will be legal expenses associated
with that. There are definitely decreases, but there are some other
things like that that are -- would be offsetting part of it.
Jason
Aria - Jolt Equities - Analyst
So, probably a bit of staff that
you have added and that lawsuit you think it would balance out.
Cary
Claiborne - Sucampo Pharmaceuticals Inc - CFO
I think -- yes,
without being specific, I think that is the way to think about it.
Jason
Aria - Jolt Equities - Analyst
Great, and I am sorry, this has
probably been asked in the Abbott Japan questions, but I am confused
about your revenue recognition. You recognize revenue as you sell
product to Abbott? So, in other words, it's not based on their stocking,
their selling into the channel or sell through. Is that correct? Or is
it --
Cary Claiborne - Sucampo Pharmaceuticals Inc - CFO
That
is correct.
Jason Aria - Jolt Equities - Analyst
Okay.
Cary
Claiborne - Sucampo Pharmaceuticals Inc - CFO
That's correct.
Jason
Aria - Jolt Equities - Analyst
So, really, it's completely --
could be completely non-correlated with either their selling into the
channel or the sell-through.
Call
Cary Claiborne -
Sucampo Pharmaceuticals Inc - CFO
Well, I guess the way to think
about it is that it is ahead of them selling into the market.
Jason
Aria - Jolt Equities - Analyst
Yes.
Cary Claiborne -
Sucampo Pharmaceuticals Inc - CFO
And then they will sell in the
market and then replenish with additional orders to place to us and then
we sell to them. The other thing that is important to note when you
think about it that way, is you don't want to necessarily take that $5
million in the fourth quarter and just annualize it when you think about
2013 because they may order sporadically and not necessarily order the
same amount every month from us.
Jason Aria - Jolt
Equities - Analyst
Sure.
Cary Claiborne - Sucampo Pharmaceuticals Inc - CFO
But you
will -- the trends should correlate if they're increasing selling more
-- increasingly selling more in the market, then their orders to us
would income.
Jason Aria - Jolt Equities - Analyst
Sure.
And so do you think -- when you think about that $5 million, do you
think that that is essentially what they put into the channel in
initially? Or do you think there is some sell-through expectation there?
How do you view what they doing? Maybe they have given you some guidance.
Cary
Claiborne - Sucampo Pharmaceuticals Inc - CFO
Andrew, do you want
to comment on that? I know they -- we're very pleased with the
robustness of their launch. They have a lot of reps out in the field in
the early data we received on their detailing, they were doing a lot of
detailing. But because of confidentiality, we can't really discuss their
sales.
Jason Aria - Jolt Equities - Analyst
Understand.
Andrew
Smith - Sucampo Pharmaceuticals Inc - VP, Operations & Finance
And
I don't think -- I would just reiterate the point earlier, that the
launch was on November 22, and we had -- that the sales we're
recognizing in the fourth quarter. It's a very early stage.
Jason
Aria - Jolt Equities - Analyst
Well, again, congratulations on a
nice quarter, nice to see AMITIZA holding up so well, and thanks.
Andrew
Smith - Sucampo Pharmaceuticals Inc - VP, Operations & Finance
Thanks.
Cary
Claiborne - Sucampo Pharmaceuticals Inc - CFO
Thank you.
Operator
(Operator
Instructions) You have a follow-up question coming from the line of Tim
Lynch with Stonepine Capital. You may proceed.
Tim Lynch -
Stonepine Capital - Analyst
One last question, guys. I know you said
late April is the PDUFA for OIC for AMITIZA, can you tell us the PDUFA
date so we can be sure to be paying attention and be prepared for the
potential results?
Taryn Joswick - Sucampo Pharmaceuticals
Inc - VP Clinical Development
Yes, hi. This is Taryn again. Yes, we
have not disclosed the exact PDUFA date and certainly, we are very
pleased with how the review is progressing, I can tell you that much.
And certainly, we expect to receive FDA's final decisions on or before
that date in late April.
Tim Lynch - Stonepine Capital -
Analyst
All right. Thank you.
Operator
There are no
further questions in the queue at this time. I would now like to turn
the call over to Silvia Taylor for closing remarks. You may proceed.
Silvia
Taylor - Sucampo Pharmaceuticals Inc - SVP, IR
Thank you,
everyone, for joining us this evening. We look forward to speaking with
you again soon. If you have any followup questions, please do not
hesitate to contact me. Thanks, and good night.
Operator
Thank
you for your participation on today's conference. This concludes the
presentation. You may now disconnect. Have a great day.