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):  April 4, 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 7.01. Regulation FD Disclosure.

During April 4-5, 2013, Sucampo Pharmaceuticals, Inc. (“Company”) will make corporate update presentations at one-on-one meetings with analysts and investors and at an investor conference in New York City, NY. On April 5, 2013, the Company will make a corporate update presentation via webcast at an investor conference in New York City, NY at the 20th Annual Future Leaders in the Biotech Industry Conference. All meetings will include modifications to eight slides from those slides filed on Form 8K dated January 7, 2013 and six new slides.  The additional slides are being furnished as Exhibit 99.1 to this Current Report on Form 8-K.

The information in this Item 7.01 and Exhibit 99.1 to this Form 8-K shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (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, 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
 

 

99.1           The modifications of the eight slides and the six new slides to the corporate update presentation slides dated April 5, 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: April 4, 2013 By:  

/s/ Thomas J. Knapp

 

Name:

Thomas J. Knapp

 

Title:

EVP, Chief Legal Officer and Corporate Secretary

Exhibit 99.1



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1 Sucampo Snapshot: Prostone Pioneers Commercial-stage, global pharmaceutical company • 2 FDA-approved drugs based on our proprietary prostone technology – AMITIZA® (lubiprostone) in gastroenterology – RESCULA® (unoprostone isopropyl) in ophthalmics Prostone pioneers • Therapeutic potential 1st identified by Sucampo’s founders, Drs Ryuji Ueno and Sachiko Kuno Sucampo Mission To develop and commercialize prostone-based medicines to meet the major unmet medical needs of patients on a global basis ® Registered trademark of Sucampo


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2 Global AMITIZA Approvals and Regulatory Filings Japan CC (2012)2 UK CIC (2012) OIC (filed 1Q13) US CIC (2006) IBS-C (2008) OIC sNDA1 Priority Review (April 2013) Switzerland CIC (2009) OIC (filed 1Q13) AMITIZA has been used for >7 y with >7 million prescriptions by patients suffering from chronic idiopathic constipation and irritable bowel syndrome with constipation 1 $10M milestone from Takeda upon first OIC sale 2 $15M milestone received from Abbott Japan upon first sale See Reference 1


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3 Opioid-Induced Constipation: Increase Potential Population for AMITIZA and Strengthen Efficacy Positioning • More than 230 M prescriptions for opioid use in the U.S. annually • Moderate−severe OIC affects ~2.0M−2.5M patients – Currently no approved oral product for OIC – Most common reason for discontinuation of opioid therapy – OIC patients are viewed as “difficult to treat” and are dissatisfied – PCPs welcome 1 medicine indicated for multiple causes of constipation • AMITIZA does not act on opiate receptors or inhibit analgesic activity of opioid therapy • Mu-opioid−receptor agonist compounds under development may have cardiac safety concerns See References 11-14 FDA priority review action date: late April 2013


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4 Summary and Outlook for AMITIZA • Continue growth in US: over 7M prescriptions used over 7+ years, with favorable benefit-risk profile • Near-term goals – Leverage new US product label, which removed pregnancy warnings and precautions (including removal of requirement for negative pregnancy test prior to therapy initiation), clarified information regarding use in pregnant and/or nursing women, and expanded labeling text of the Mechanism of Action – Seek approvals for OIC indication in US, UK and Switzerland – Expand global approvals and launches for AMITIZA worldwide – Develop and seek approval for AMITIZA in pediatric constipation • Currently unmet medical need; no approved prescription medications – Develop liquid formulation of AMITIZA for pediatric and long-term care markets See Reference 1


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5 RESCULA US Launch Overview • sNDA approved December 2012 – RESCULA may be used as a first-line agent or concomitantly with other topical ophthalmic drug products to lower intraocular pressure – RESCULA is a BK (Big Potassium) channel activator, which is different from other intraocular pressure (IOP) lowering agents. – RESCULA is believed to reduce elevated IOP by increasing the outflow of aqueous humor through the trabecular meshwork • RESCULA launch in US Q1 2013 – 40 specialty reps; expect 11% share of voice – Positive feedback and significant progress • More than 7,000 face-to-face calls • Over 60,000 samples shipped • 48 face-to-face meetings with plans and PBMs


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6 Sucampo’s Clinical Pipeline CLINICAL FOCUS STAGE OF CLINICAL DEVELOPMENT COMPOUNDS DISCOVERY PRECLINICAL PHASE 1 PHASE 2 PHASE 3 FILING AMITIZA CIC UK/CH Launch 1Q13 AMITIZA OIC US Filed 3Q12 AMITIZA OIC UK/CH Filed 1Q13 AMITIZA Pediatric Constipation FPFV 2H13 RESCULA POAG/OH US Launched 1Q13 Unoprostone Isopropyl RP Japan/US 1Q13 Cobiprostone Oral Mucositis 4Q12 SPI-017 IV Spinal Stenosis 1Q13 SPI-3608 PO Spinal Stenosis 4Q12 Successfully completed Approval pending Projected start or submission


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7 Trading Symbol SCMP (NASDAQ) Corporate Headquarters Bethesda, MD Stock Price (03-29-2013), 52-Week Range $6.54, $8.50 to $3.78 Shares Outstanding (12-31-2012) 41.9 M (1 class of common stock) Daily Volume (90-day average) 120,397 Market Capitalization (03-29-2013) $274.5 M Debt (12-31-12) $52.9 M Cash & Equivalents (12-31-12) $91.4 M Enterprise Value (03-29-2013) $235.9 M YTD Total Revenue (12-31-2012) $81.5 M Full-time Employees (03-29-2013) 124 Fiscal Year Ends December 31 Accounting Firm PricewaterhouseCoopers, LLP Key Facts


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8 2013 Key Value Drivers �� Completed �� In Process �� Obtain approval of OIC sNDA: Q2 2013 • $10M milestone payment upon first OIC sale �� Achieve FPFV in Pediatric P3 trial by H2 2013 US AMITIZA �� Grow sales in Japan in 2013 Japan �� Submit for regulatory approval of OIC in Switzerland and UK by Q1 2013 �� Seek NICE endorsement for CIC and OIC and make AMITIZA available in UK �� Begin 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


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9 Terms of Sucampo’s AMITIZA Agreements • Takeda Agreement – Takeda shall promote, market, and sell AMITIZA in US and Canada – Sucampo’s tiered royalty rate: 18%−26% of annual net sales – Sucampo earned $20M in upfront and $130M in development milestone payments as of 9/30/12 – Sucampo received $106M in reimbursement for R&D expenses from Takeda • Abbott Japan Agreement – Abbott Japan shall promote, market, and sell AMITIZA in Japan – Sucampo will sell product to Abbott Japan at discount to Abbott Japan’s approved reimbursement price – Sucampo earned $10M in upfront and $12.5M in development milestone payments as of 9/30/12 – Sucampo earned $15M milestone payment on 1st commercial sale in Japan by Abbott Japan in 4Q12


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10 Substantial Abdominal Pain Improvement in IBS-C Patients Reporting at Least Severe Abdominal Pain at Baseline* % Improvement Placebo BID (n = 94) Lubiprostone 8 µg BID (n = 183) P Value† ≥10 53.9% 61.9% <0.0001 ≥20 40.1% 49.6% <0.0001 ≥30 24.2% 35.1% <0.0001 ≥40 14.5% 23.7% <0.0001 ≥50 9.4% 16.7% <0.0001 ≥60 4.7% 12.7% <0.0001 *LOCF analysis; †P value from CMH test. See Reference 25


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11 US Patent No. Expires Type of patent 5,284,858 2014 Composition of matter (drug substance) 6,414,016 2020 Therapeutic use (treating constipation) 6,583,174 2020 Composition of matter (drug product) 7,064,148 2022 Therapeutic use (treating constipation) 7,417,067 2020 Composition of matter (drug product) 7,795,312 2024 Therapeutic use (treating IBS) 8,026,393 2027 Composition of matter (drug product) 8,071,613 2020 Therapeutic use (treating constipation) 8,088,934 2021 Composition of matter (drug substance) 8,097,649 2020 Composition of matter (drug product) 8,097,653 2022 Therapeutic use (treating constipation) 8,114,890 2020 Composition of matter (drug product) 8,338,639 2027 Composition of matter (drug product) 8,389,542 2022 Composition of matter (drug product) and therapeutic use (treating constipation) Issued Lubiprostone Patents *For Orange Book-listed patents concerning lubiprostone, see for example: http://www.accessdata.fda.gov/scripts/cder/ob/docs/patexclnew.cfm?Appl_No=021908&Product_No=001&table1=OB_Rx or http://www.accessdata.fda.gov/scripts/cder/ob/docs/patexclnew.cfm?Appl_No=021908&Product_No=002&table1=OB_Rx


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12 Japanese Patent No. Expires * Type of patent 4,332,316 2020 Composition of matter (drug substance) 4,332,353 2022 Therapeutic use (treating OIC) 4,684,334 2021 Therapeutic use (treating constipation) 4,783,794 2027 Composition of matter (drug product) 4,786,866 2022 Therapeutic use (treating constipation) 4,852,229 2022 Therapeutic use (treating constipation) 4,889,219 2023 Therapeutic use (treating IBS) * The term of the plural eligible patents may be extended up to 5 years. European Patent No. Expires * Type of Patent 1,220,849 2020 Composition of matter (drug product) 1,315,485 2021 Therapeutic use (treating constipation) 1,392,318 2022 Therapeutic use (treating OIC) 1,426,361 2020 Composition of matter (drug substance) 1,443,938 2022 Therapeutic use (treating constipation) * The term of one of the eligible patents may be extended up to 5 years. Issued Lubiprostone Patents


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13 US Patent No. Expires Type of patent 6,770,675 2018 Composition of matter (drug product) and therapeutic use (treating ocular hypertension) 6,458,836 2021 Therapeutic use (treating ocular hypertension and glaucoma) Issued Unoprostone Isopropyl Patents *For Orange Book-listed patents concerning unoprostone isopropyl, see for example: http://www.accessdata.fda.gov/scripts/cder/ob/docs/patexclnew.cfm?Appl_No=021214&Product_No=001&table1=OB_Rx


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14 AMITIZA Mechanism of Action: ClC-2 Ion-Channel Activation and Fluid Secretion Highly selective activation of ClC-2 channels in intestinal lumen Chloride efflux followed by passive efflux of sodium into small intestine Enhanced intestinal fluid secretion without alteration of serum electrolyte levels See Reference 1