e8vk
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): May 8, 2008
Sucampo Pharmaceuticals, Inc.
(Exact Name of Registrant as Specified in Charter)
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Delaware
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001-33609
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13-3929237 |
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(State or Other Juris-
diction of Incorporation)
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(Commission
File Number)
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(IRS Employer
Identification No.) |
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4520 East-West Highway, Suite 300
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20814 |
Bethesda, Maryland |
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(Address of Principal Executive Offices)
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(Zip Code) |
Registrants 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):
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Item 2.02 Results of Operations and Financial Condition
On May 8, 2008, Sucampo Pharmaceuticals, Inc. announced its consolidated financial results for
the quarter ended March 31, 2008. The full text of the press release issued in connection with the
announcement is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The information in this Form 8-K (including Exhibit 99.1) shall not be deemed filed for
purposes of Section 18 of the Securities Exchange Act of 1934 (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 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 Item 2.02 shall be deemed to be furnished, and not filed:
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99.1 |
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Press Release issued by the registrant on May 8, 2008. |
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.
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SUCAMPO PHARMACEUTICALS, INC.
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Date: May 8, 2008 |
By: |
/s/ MARIAM E. MORRIS
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Name: |
Mariam E. Morris |
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Title: |
Chief Financial Officer |
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EXHIBIT INDEX
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Exhibit No. |
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Description |
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99.1
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Press release issued by the registrant on May 8, 2008 |
exv99w1
Exhibit
99.1
Mariam E. Morris
Chief Financial Officer
Sucampo Pharmaceuticals, Inc.
301-961-3400
mmorris@sucampo.com
Sucampo Pharmaceuticals Reports Financial Results
for the First Quarter of 2008
Sucampo Pharmaceuticals and Takeda Pharmaceuticals Prepare for the Commercial Launch of
AMITIZA® (lubiprostone) 8 mcg for the Treatment of Irritable Bowel Syndrome with
Constipation in Women over 18 Years of Age and Older
Submission of European Marketing Authorization Applications Moves Sucampo
Pharmaceuticals Closer to International Introduction of Lubiprostone
Bethesda, Md., May 8, 2008 Sucampo Pharmaceuticals, Inc. (NASDAQ: SCMP) today reported its
consolidated financial results for the quarter ended March 31, 2008.
First Quarter 2008 and Other Highlights
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On April 29, 2008, the U.S. Food and Drug Administration (FDA) approved
AMITIZA® (lubiprostone) 8 mcg for the treatment of irritable bowel syndrome with
constipation (IBS-C) in women 18 years of age and older. |
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The FDA approval triggered a development milestone payment of $50.0 million from Takeda
to be fully recognized in the second quarter of 2008. |
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The approval of AMITIZA 8 mcg for IBS-C represents Sucampos second consecutive
application obtained within the PDUFA timeline. |
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Product royalty revenue increased $3.8 million to $6.1 million in the first quarter of
2008 from $2.3 million in the first quarter of 2007. |
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Sucampo submitted a Marketing Authorization Application (MAA) for lubiprostone, 24 mcg,
for the indication of Chronic Idiopathic Constipation in adults in nine European countries
using the decentralized application procedure. |
Over the last several months, Sucampo continued in its exciting mission to bring drugs from
discovery to patient bedside, said Ryuji Ueno, M.D., Ph.D., Ph.D., founder, chairman and chief
executive officer. We accomplished a significant milestone in our goal to bring lubiprostone to
the European market by submitting the MAA, we are continuing in our clinical development process in
Japan, we are proceeding with the development of our other clinical stage prostone
compounds and we have selected six additional prostone compounds for initial pharmacologic studies.
We are very pleased with the recent FDA approval of AMITIZA 8 mcg for the IBS-C indication and we
are working closely with our co-promotion partner, Takeda, on the full-scale commercial launch,
which will begin before the end of June. AMITIZA 8 mcg for IBS-C will be the focus of multiple
scientific presentations at the Digestive Disease Week conference in San Diego, CA from May 17 to
May 22, 2008, the largest gastroenterology meeting in the world.
Financial Results
Total revenues in the quarter ended March 31, 2008 increased $594,000, or 5%, to $13.6 million from
$13.0 million in the quarter ended March 31, 2007.
The key components of total revenues are as follows:
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Product royalty revenue increased $3.8 million to $6.1 million in the first quarter of
2008 compared with $2.3 million in the first quarter of 2007. The increase reflected the
continuing acceptance by patients and physicians of AMITIZA 24 mcg for the treatment of
Chronic Idiopathic Constipation in adults since its commercial launch in April 2006. |
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Research and development (R&D) revenue decreased $3.3 million to $6.1 million in the
first quarter of 2008 from $9.4 million in the first quarter of 2007. The decrease in R&D
revenue was primarily due to the recognition of AMITIZA-related deferred revenue during the
first quarter of 2007 resulting from payments received from Takeda for development of
AMITIZA to treat Chronic Idiopathic Constipation and IBS-C. We recognized revenue for this
development work ratably over the estimated performance period which was completed in June
2007 when we filed the supplemental new drug application (sNDA) for the IBS-C indication
and there is no equivalent amount in the first quarter of 2008. |
In the first quarter of 2008, Sucampo reported net income of $505,000, or $0.01 per diluted share,
based on 42.1 million weighted average diluted common shares outstanding, compared with net income
of $516,000, or $0.01 per diluted share, in the first quarter of 2007, based on 35.4 million
weighted average diluted common shares outstanding.
In the first quarter of 2008, Sucampo recorded a tax benefit of $5.6 million compared with a tax
provision of $341,000 in the first quarter of 2007. As a result of the approval of the sNDA for
IBS-C and the related impact on projected income from the $50.0 million milestone payment to be
recognized in the second quarter of 2008 and expected increase in product royalties, Sucampo now
believes that its U.S. deferred tax assets will be realized. As such, the tax benefit in the first
quarter of 2008 is due primarily to a discrete release of U.S. deferred tax asset valuation
allowances of $4.8 million and a reduction in the projected annual effective tax rate applied to
pre-tax income in the first quarter of 2008. Sucampo had previously disclosed in its 2007 Annual
Report on Form 10-K that such FDA approval, if received, may lead to a reversal of deferred tax
asset valuation allowances.
The net income in the first quarter of 2008 resulted primarily from the increase in product royalty
revenue and the increased tax benefit, partially offset by increases in R&D expenditures,
reflecting initiatives to expand the companys current product candidate pipeline and costs
associated with the MAA process in Europe, as well as increases in product and milestone royalty
expenses to Sucampo AG, a Swiss patent-holding company and an affiliate. In addition, Sucampo
experienced higher general and administrative (G&A) costs associated with increased headcount,
non-cash stock-based compensation expense, the lease of new office space and overall costs
associated with being a publicly-traded company with international operations.
Total operating expenses incurred during the first quarter of 2008 increased $6.9 million to $19.3
million from $12.4 million in the first quarter of 2007.
Components of operating expenses are as follows:
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The increase in R&D expenses of $4.2 million to $10.1 million during the first quarter
of 2008 from $5.9 million in the first quarter of 2007 was associated with Sucampos
on-going clinical development programs of AMITIZA for the treatment of Opioid-induced Bowel
Dysfunction and cobiprostone for the treatment of Non-steroidal Anti-inflammatory Drug-
(NSAID) Induced Ulcers, and pre-clinical and basic development costs associated with
SPI-017 and other prostone compounds. Sucampo incurred filing and data purchase costs of
$2.5 million, which were necessary to submit the MAA in Europe. The European applications
also triggered an obligation to pay a $1.0 million milestone royalty to Sucampo AG. |
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The increase in G&A expenses of approximately $1.6 million to $4.4 million during the
first quarter of 2008 from $2.8 million in the first quarter of 2007 was primarily the
result of an increase in operational headcount and related non-cash
stock option expenses of
$590,000, an increase in rent and depreciation expenses associated with the companys new
office space of $510,000 and an increase in overall costs associated with the compliance
and regulatory requirements of being a publicly-traded company with international
operations. |
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The decrease in selling and marketing expenses of $463,000 to $2.8 million during the
first quarter of 2008 from $3.2 million in the first quarter of 2007 reflected savings
achieved as a result of moving commercial activities from a third-party contract sales
organization to an internal sales force. |
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The increase in product royalties related parties of $670,000 to $1.1 million in the
first quarter of 2008 from $411,000 in the first quarter of 2007
resulted directly from the
companys increase in product royalty revenue. |
Sucampos cash, cash equivalents and investments totaled $84.9 million at March 31, 2008 as
compared with $86.5 million at the end of 2007, including investments, classified as non-current,
in auction rate securities of $26.3 million at March 31, 2008 and $9.4 million at December 31,
2007.
We continue to fulfill our strategy to fund our business operations through on-going sales of
AMITIZA and fund the advancement of our product candidate pipeline via milestone payments. The
$50.0 million development milestone payment from Takeda for the successful approval of AMITIZA 8
mcg for IBS-C and anticipated increase in product royalty revenue will further strengthen not only
our financial position but also our ability to advance our mission, continued Dr. Ueno.
Company to Host Conference Call
Sucampo Pharmaceuticals will host a conference call at 10:00 a.m. ET Thursday, May 8, 2008 to
discuss its first quarter 2008 financial results. To participate on the live call, please dial
(877) 407-5790 (domestic) or (201) 689-8328 (international). A live and archived audio webcast of
the call will be available via the For Investors page of the Sucampo Pharmaceuticals website,
www.sucampo.com. Please dial in or log on through Sucampo Pharmaceuticals website approximately
10 minutes prior to the scheduled start time.
About Sucampo Pharmaceuticals, Inc.
Sucampo Pharmaceuticals, Inc., a specialty biopharmaceutical company based in Bethesda, MD, focuses
on the development and commercialization of medicines based on prostones. The therapeutic
potential of prostones, which are bio-lipids that occur naturally in the human body, was first
identified by Ryuji Ueno, M.D., Ph.D., Ph.D., Sucampo Pharmaceuticals Chairman and Chief Executive
Officer. Dr. Ueno founded Sucampo Pharmaceuticals in 1996 with Sachiko Kuno, Ph.D., founding Chief
Executive Officer and advisor, international business development.
Sucampo Pharmaceuticals is marketing AMITIZA® (lubiprostone) 24 mcg in the U.S. for chronic
idiopathic constipation in adults and is developing the drug for additional gastrointestinal
disorders with large potential markets. AMITIZA 8 mcg was recently approved by the FDA to treat
irritable bowel syndrome with constipation in adult women. In addition, Sucampo Pharmaceuticals has
a robust pipeline of compounds with the potential to target underserved diseases affecting millions
of patients worldwide. Sucampo Pharmaceuticals has two wholly owned subsidiaries: Sucampo Pharma
Europe, Ltd. headquartered in Oxford, UK with a branch office in Basel, Switzerland, and Sucampo
Pharma, Ltd. located in Tokyo and Osaka, Japan. To learn more about Sucampo Pharmaceuticals and its
products, visit www.sucampo.com.
Forward-Looking Statements
Any statements in this press release about future expectations, plans and prospects for Sucampo
Pharmaceuticals are forward-looking statements made under the provisions of The Private Securities
Litigation Reform Act of 1995. Forward-looking statements may be identified by the words project,
believe, anticipate, plan, expect, estimate, intend, should, would, could,
will, may or other similar expressions. Actual results may differ materially from those
indicated by such forward-looking statements as a result of various important factors described in
Sucampo Pharmaceuticals filings with the Securities and Exchange Commission (SEC), including the
annual report on Form 10-K for the year ended December 31, 2007 and other periodic reports filed
with the SEC. Any forward-looking statements in this press release represent Sucampo
Pharmaceuticals views only as of the date of this release and should not be relied upon as
representing its views as of any subsequent date. Sucampo Pharmaceuticals anticipates that
subsequent events and developments will cause its views to change. However, while Sucampo
Pharmaceuticals may elect to update these forward-looking statements publicly at some point in the
future, Sucampo Pharmaceuticals specifically disclaims any obligation to do so, whether as a result
of new information, future events or otherwise.
SUCAMPO PHARMACEUTICALS, INC.
Consolidated Statements of Operations
(In thousands, except per share data)
(Unaudited)
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Three Months Ended March 31, |
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2008 |
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2007 |
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Revenues: |
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Research and development revenue |
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$ |
6,110 |
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$ |
9,366 |
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Product royalty revenue |
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6,080 |
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2,309 |
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Co-promotion revenue |
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1,222 |
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1,132 |
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Contract revenue related parties |
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105 |
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116 |
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Collaboration revenue |
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37 |
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37 |
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Total revenues |
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13,554 |
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12,960 |
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Operating expenses: |
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Research and development |
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10,082 |
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5,946 |
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General and administrative |
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4,381 |
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2,833 |
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Selling and marketing |
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2,768 |
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3,231 |
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Product royalties related parties |
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1,081 |
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411 |
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Milestone royalties related parties |
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1,031 |
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Total operating expenses |
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19,343 |
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12,421 |
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(Loss) income from operations |
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(5,789 |
) |
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539 |
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Non-operating income (expense): |
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Interest income |
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642 |
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324 |
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Other income (expense), net |
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12 |
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(6 |
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Total non-operating income, net |
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654 |
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318 |
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(Loss) income before income taxes |
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(5,135 |
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857 |
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Income tax benefit (provision) |
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5,640 |
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(341 |
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Net income |
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$ |
505 |
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$ |
516 |
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Net income per share: |
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Basic net income per share |
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$ |
0.01 |
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$ |
0.01 |
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Diluted net income per share |
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$ |
0.01 |
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$ |
0.01 |
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Weighted average common shares outstanding basic |
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41,733 |
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34,990 |
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Weighted average common shares outstanding diluted |
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42,061 |
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35,429 |
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SUCAMPO PHARMACEUTICALS, INC.
Consolidated Balance Sheets
(In thousands, except share data)
(Unaudited)
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March 31, 2008 |
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December 31, 2007 |
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ASSETS: |
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Current assets: |
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Cash and cash equivalents |
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$ |
32,733 |
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$ |
25,559 |
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Investments, current |
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25,912 |
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51,552 |
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Product royalties receivable |
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6,080 |
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8,667 |
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Unbilled accounts receivable |
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4,987 |
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5,883 |
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Accounts receivable |
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1,886 |
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1,525 |
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Prepaid and income taxes receivable |
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119 |
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1,922 |
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Deferred tax
assets current, net |
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926 |
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88 |
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Prepaid expenses and other current assets |
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2,332 |
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2,222 |
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Total current assets |
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74,975 |
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97,418 |
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Investments, non-current |
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26,301 |
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9,400 |
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Property and equipment, net |
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2,334 |
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2,265 |
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Deferred tax assets non-current, net |
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5,887 |
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551 |
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Other assets |
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412 |
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393 |
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Total assets |
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$ |
109,909 |
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$ |
110,027 |
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LIABILITIES AND STOCKHOLDERS EQUITY: |
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Current liabilities: |
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Accounts payable |
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$ |
4,820 |
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$ |
3,313 |
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Accrued expenses |
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7,160 |
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8,730 |
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Deferred revenue current |
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885 |
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1,062 |
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Total current liabilities |
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12,865 |
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13,105 |
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Deferred revenue, net of current portion |
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8,485 |
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8,626 |
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Other liabilities |
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1,735 |
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1,768 |
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Total liabilities |
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23,085 |
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23,499 |
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Commitments |
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Stockholders equity: |
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Class A common stock, $0.01 par value;
270,000,000 shares authorized at March 31,
2008 and December 31, 2007; 15,542,768
shares and 15,538,518 shares issued and
outstanding at March 31, 2008 and
December 31, 2007, respectively |
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155 |
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155 |
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Class B common stock, $0.01 par value;
75,000,000 shares authorized at March 31,
2008 and December 31, 2007; 26,191,050
shares issued and outstanding at March 31,
2008 and December 31, 2007 |
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|
262 |
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|
262 |
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Additional paid-in capital |
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96,981 |
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96,680 |
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Accumulated other comprehensive loss |
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(903 |
) |
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(393 |
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Accumulated deficit |
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(9,671 |
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(10,176 |
) |
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Total stockholders equity |
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86,824 |
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|
86,528 |
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Total liabilities and stockholders equity |
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$ |
109,909 |
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|
$ |
110,027 |
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