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): March 11, 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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Bethesda, Maryland
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20814 |
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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):
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o 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 |
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Results of Operations and Financial Condition |
On March 11, 2008, Sucampo Pharmaceuticals, Inc. announced its consolidated financial results
for the fourth quarter and year ended December 31, 2007. 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.
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Item 9.01 |
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Financial Statements and Exhibits |
(d) Exhibits
The following exhibit relating to Item
2.02 shall be deemed to be furnished, and not filed:
99.1 Press Release issued by the registrant on March 11, 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: March 11, 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 March 11, 2008 |
exv99w1
Exhibit 99.1
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Mariam Morris
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or
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P. Curtis Schenck |
Chief Financial Officer
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Director, Investor Relations |
Sucampo Pharmaceuticals, Inc.
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Sucampo Pharmaceuticals, Inc. |
301-961-3400
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301-961-3400 |
mmorris@sucampo.com
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cschenck@sucampo.com |
Sucampo Pharmaceuticals Reports Financial Results
for the Fourth Quarter and Full Year of 2007
AMITIZA® Sales and R&D Success Fuel Growth
Bethesda, Md., March 11, 2008 Sucampo Pharmaceuticals, Inc. (NASDAQ: SCMP) today reported its
consolidated financial results for the fourth quarter and year ended December 31, 2007. The Company
achieved its second consecutive year of profitability and continued to strengthen its financial
position.
Fourth-Quarter 2007 Highlights
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Product royalty revenue increased by $6.6 million, or more than 300%, year-over-year on
growth of U.S. sales of AMITIZA® (lubiprostone, 24 mcg), for Chronic Idiopathic
Constipation in adults. |
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Sucampo and co-marketing partner Takeda Pharmaceutical Company, Ltd. (Takeda) initiated
a national television Direct-To-Consumer (DTC) marketing campaign for AMITIZA®. |
Full-Year 2007 Highlights
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Sucampo reported net income of $13.2 million, or $0.35 per diluted share, for the year
ended December 31, 2007. Sucampo strengthened its liquidity and capital resources with cash
and cash equivalents of $25.6 million and investments of $61.0 million and total
shareholders equity of $86.5 million at December 31, 2007. |
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Sucampo earned a $30.0 million milestone payment from Takeda upon submission of a
supplemental New Drug Application (sNDA) seeking approval of AMITIZA for Irritable Bowel
Syndrome with Constipation (IBS-C). |
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Sucampo completed an initial build-out of internal specialty sales force targeting
long-term care facilities as well as medical schools and university hospitals. |
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Sucampo completed an initial public offering that raised $28.2 million in net proceeds. |
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Sucampo initiated full Phase III studies of AMITIZA for Opioid-Induced Bowel Dysfunction
(OBD). |
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Sucampo began a Phase II study of a second compound, cobiprostone, for the prevention of
Non-Steroidal Anti-Inflammatory Drug (NSAID)-induced ulcers. |
In recent months, Sucampo has achieved a number of operational and financial objectives that
demonstrate the success of AMITIZA® in the U.S. and the potential for lubiprostone
abroad as we focus on expanding into new indications and entering new markets, said Ryuji Ueno,
M.D., Ph.D., Ph.D., founder, chairman and chief executive officer. The launch of the television
DTC campaign for AMITIZA®, combined with the efforts of our internal specialty sales
force, has helped to drive sales growth and build brand recognition among patients and physicians.
We are optimistic that we will be able to capitalize on the positive awareness of
AMITIZA®.
Financial Results
Total revenues for the quarter ended December 31, 2007 increased 51% to $17.1 million from $11.4
million for the fourth quarter ended December 31, 2006 and increased 55% to $91.9 million for the
year ended December 31, 2007 from $59.3 million for the year ended December 31, 2006.
The key components of total revenues are as follows:
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Product royalty revenue increased to $8.7 million for the fourth quarter of 2007
compared with $2.0 million for the fourth quarter of 2006; and product royalty revenue
increased to $27.5 million for the year ended December 31, 2007 from $6.6 million in 2006.
The increase reflects the significant growth in the U.S. sales of AMITIZA® 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 declined slightly to $7.3 million for the fourth
quarter of 2007 from $7.5 million for the fourth quarter of 2006. R&D revenue increased to
$59.4 million for the year ended December 31, 2007 from $46.4 million in 2006, due
primarily to the $30.0 million milestone payment earned from Takeda in June 2007 upon the
filing of the sNDA for AMITIZA for the treatment of IBS-C, offset in part by a decline of
$17.0 million of R&D reimbursement payments from Takeda reflecting the recognition of
AMITIZA related deferred revenue for six months in 2007, when the related performance
period was completed, compared with twelve months in 2006. |
In the fourth quarter of 2007, Sucampo reported a net loss of $0.7 million, or $0.02 per diluted
share, based on 41.7 million weighted average diluted common shares outstanding, compared with net
income of $4.9 million, or $0.14 per diluted share, for the fourth quarter of 2006, based on 35.3
million weighted average diluted common shares outstanding. In the fourth quarter of 2007, Sucampo
recorded $0.1 million in net tax benefits versus $4.9 million in net tax benefits for the fourth
quarter of 2006 resulting from the recognition of deferred tax assets. Sucampo
reported a loss before income taxes of $0.9 million in the fourth quarter of 2007 compared with
income before income taxes of $40,000 in the fourth quarter of 2006. The loss for the fourth
quarter of 2007 resulted primarily from increases in R&D expenses to expand our current pipeline
initiatives and an increase in overall costs associated with being a publicly-traded company,
including insurance costs and fees for legal, accounting, Sarbanes-Oxley Act compliance and other
professional services.
For the year ended December 31, 2007, Sucampo reported net income of $13.2 million, or $0.35 per
diluted share, based on 38.2 million weighted average diluted common shares outstanding compared
with net income of $21.8 million, or $0.63 per diluted share for 2006, based on 34.7 million
weighted average diluted common shares outstanding. For 2007, Sucampo recorded a tax provision of
$7.8 million compared with an income tax benefit of $4.9 million in 2006. Sucampo reported income
before income taxes of $21.0 million for 2007 compared with income before income taxes of $16.9
million in 2006. The increase in income before taxes for 2007 resulted primarily from the
significant growth of our product royalty revenue associated with the U.S. sales of
AMITIZA®.
Total operating expenses incurred during the fourth quarter of 2007 increased to $19.3 million from
$11.9 million for the fourth quarter of 2006 and increased to $73.5 million for the year ended
December 31, 2007 compared with $44.5 million in 2006.
The key components of the operating expense increases are as follows:
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The increase in R&D expenses of $11.9 million to $28.3 million during the year ended
December 31, 2007 from $16.4 million in 2006 was associated with Sucampos clinical
development programs for IBS-C, the initiation of its OBD clinical studies of AMITIZA and
the initiation of its NSAID clinical study of cobiprostone, as well as its ongoing
development of other prostone compounds. |
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The increase in general and administrative (G&A) expenses of $10.4 million to $25.0
million during the year ended December 31, 2007 from $14.6 million in 2006 was primarily
the result of a one-time cash and stock-based awards to Sucampos founders of $9.2 million
for stock options previously granted and now terminated. G&A expenses also reflected higher
operational headcount and higher rent expense for new leased office space, and additional
costs associated with being a publicly-traded company. |
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The increase in selling and marketing expenses of $2.1 million to $13.2 million during
the year ended December 31, 2007 from $11.1 million in 2006 reflected one full year of
commercial activity in 2007 for AMITIZA®, which was launched in the second
quarter of 2006. |
Dr. Ueno continued, We are proceeding from a position of financial and operational strength.
Sucampos cash and cash equivalents and investments totaled $86.5 million at the end of 2007 as
compared with $51.9 million at the end of 2006. This position could enable Sucampo to in-license
and market select drugs. I should also point out that on-going sales of AMITIZA® are
helping to fund the advancement of our pipeline of future drug candidates. Also, if Sucampo
succeeds in advancing AMITIZA® for approval for additional therapeutic indications,
those developments could trigger milestone payments as well as an increase in product royalties.
Under the Prescription Drug User Fee Act of 1992, Sucampo expects the U.S. Food and Drug
Administrations decision regarding its sNDA for AMITIZA for the treatment of IBS-C on or about
April 29, 2008. If the drug is approved for this indication, Sucampo would receive a $50.0 million
milestone payment from Takeda.
Sucampo enjoyed an outstanding year in 2007 and we look forward to accomplishing a number of
significant milestones in the year ahead, said Dr. Ueno.
Company
to Host Conference Call
In conjunction with its fourth quarter and full year financial results, Sucampo will host a
conference call at 10:00 a.m. ET Tuesday, March 11, 2008. To participate on the live call, please
dial (866) 700-6293 (domestic) or (617) 213-8835 (international) and providing the participant
passcode 65493260. A replay of the call will be available until midnight Tuesday, March 25, 2008 by
dialing (888) 286-8010 (U.S. and Canada) or (617) 801-6888 (international). Confirmation code for
the replay is 52571342. 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) in the U.S. for chronic idiopathic
constipation in adults and is developing the drug for additional gastrointestinal disorders with
large potential markets. 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
quarterly report on Form 10-Q for the period ended September 30, 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 (unaudited)
(In thousands, except per share data)
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Three Months Ended |
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Year Ended |
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December 31, |
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December 31, |
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2007 |
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2006 |
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2007 |
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2006 |
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Revenues: |
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Research and development revenue |
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$ |
7,274 |
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$ |
7,482 |
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$ |
59,379 |
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$ |
46,382 |
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Product royalty revenue |
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8,667 |
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2,027 |
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27,536 |
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6,590 |
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Co-promotion revenue |
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1,093 |
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1,685 |
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4,411 |
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4,243 |
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Contract revenue related parties |
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74 |
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141 |
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418 |
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404 |
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Collaboration revenue |
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37 |
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37 |
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147 |
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147 |
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Contract revenue |
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1,500 |
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Total revenues |
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17,145 |
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11,372 |
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91,891 |
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59,266 |
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Operating expenses: |
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Research and development |
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8,280 |
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4,037 |
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28,334 |
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16,392 |
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General and administrative |
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5,367 |
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3,608 |
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25,031 |
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14,587 |
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Selling and marketing |
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3,577 |
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4,030 |
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13,229 |
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11,103 |
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Product royalties related parties |
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1,536 |
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191 |
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4,890 |
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|
1,171 |
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Milestone royalties related parties |
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500 |
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2,000 |
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|
1,250 |
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Total operating expenses |
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19,260 |
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|
11,866 |
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73,484 |
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44,503 |
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(Loss) income from operations |
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(2,115 |
) |
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(494 |
) |
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18,407 |
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14,763 |
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Non-operating income (expense): |
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Interest income |
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890 |
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573 |
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2,465 |
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1,976 |
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Interest expense |
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(6 |
) |
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(90 |
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Other income, net |
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343 |
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(33 |
) |
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151 |
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255 |
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Total non-operating income, net |
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1,233 |
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534 |
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2,616 |
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2,141 |
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(Loss) income before income taxes |
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(882 |
) |
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40 |
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21,023 |
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16,904 |
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Income tax benefit (provision) |
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|
147 |
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4,897 |
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(7,833 |
) |
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4,897 |
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Net (loss) income |
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$ |
(735 |
) |
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$ |
4,937 |
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$ |
13,190 |
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$ |
21,801 |
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Net (loss) income per share: |
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Basic net (loss) income per share |
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$ |
(0.02 |
) |
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$ |
0.14 |
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$ |
0.35 |
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$ |
0.63 |
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Diluted net (loss) income per share |
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$ |
(0.02 |
) |
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$ |
0.14 |
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$ |
0.35 |
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$ |
0.63 |
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Weighted average common shares outstanding basic |
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41,730 |
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|
34,990 |
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|
37,778 |
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|
34,383 |
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Weighted average common shares outstanding diluted |
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41,730 |
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|
|
35,298 |
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|
|
38,226 |
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|
34,690 |
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SUCAMPO PHARMACEUTICALS, INC.
Consolidated Balance Sheets (unaudited)
(In thousands, except share data)
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December 31, |
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2007 |
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2006 |
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ASSETS: |
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Current assets: |
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Cash and cash equivalents |
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$ |
25,559 |
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$ |
22,481 |
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Investments, short-term |
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51,552 |
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|
29,399 |
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Accounts receivable |
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|
1,525 |
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|
1,537 |
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Unbilled accounts receivable |
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|
5,883 |
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Product royalties receivable |
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|
8,667 |
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|
|
2,029 |
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Prepaid and income taxes receivable |
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|
1,922 |
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|
|
2,355 |
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Deferred tax assets, net |
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|
88 |
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|
1,612 |
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Prepaid expenses and other current assets |
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|
2,222 |
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|
|
536 |
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Total current assets |
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97,418 |
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|
59,949 |
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Restricted cash |
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213 |
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|
213 |
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Investments, long-term |
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|
9,400 |
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|
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Property and equipment, net |
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|
2,265 |
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|
|
343 |
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Deferred tax assets noncurrent, net |
|
|
551 |
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|
|
3,289 |
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Deposits and other assets |
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|
180 |
|
|
|
3,290 |
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Total assets |
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$ |
110,027 |
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|
$ |
67,084 |
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LIABILITIES AND STOCKHOLDERS EQUITY: |
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Current liabilities: |
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Accounts payable |
|
$ |
3,313 |
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$ |
2,391 |
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Accrued expenses |
|
|
8,730 |
|
|
|
5,418 |
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Deferred revenue current |
|
|
1,062 |
|
|
|
11,517 |
|
|
|
|
|
|
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Total current liabilities |
|
|
13,105 |
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|
|
19,326 |
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Deferred revenue, net of current portion |
|
|
8,626 |
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|
|
9,192 |
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Other liabilities |
|
|
1,768 |
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|
|
33 |
|
|
|
|
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Total liabilities |
|
|
23,499 |
|
|
|
28,551 |
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Commitments |
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|
|
|
|
|
|
|
|
Stockholders equity: |
|
|
|
|
|
|
|
|
Series A convertible preferred stock, $0.01
par value; 0 and 10,000 shares authorized
at December 31, 2007 and 2006,
respectively; 0 and 3,780 shares issued and
outstanding at December 31, 2007 and 2006,
respectively |
|
|
|
|
|
|
20,288 |
|
Preferred stock, $0.01 par value; 5,000,000
and 0 shares authorized at December 31,
2007 and 2006, respectively; no shares
issued and outstanding at December 31, 2007
and 2006 |
|
|
|
|
|
|
|
|
Class A common stock, $0.01 par value;
270,000,000 and 75,000,000 shares
authorized at December 31, 2007 and 2006,
respectively; 15,538,518 and 8,799,385
shares issued and outstanding at December
31, 2007 and 2006, respectively |
|
|
155 |
|
|
|
88 |
|
Class B common stock, $0.01 par value;
75,000,000 shares authorized; 26,191,050
shares issued and outstanding at December
31, 2007 and 2006 |
|
|
262 |
|
|
|
262 |
|
Additional paid-in capital |
|
|
96,680 |
|
|
|
41,555 |
|
Accumulated other comprehensive loss |
|
|
(393 |
) |
|
|
(294 |
) |
Accumulated deficit |
|
|
(10,176 |
) |
|
|
(23,366 |
) |
|
|
|
|
|
|
|
Total stockholders equity |
|
|
86,528 |
|
|
|
38,533 |
|
|
|
|
|
|
|
|
Total liabilities and stockholders equity |
|
$ |
110,027 |
|
|
$ |
67,084 |
|
|
|
|
|
|
|
|