Sucampo Pharmaceuticals, Inc. : Reports First Quarter 2013 Financial and Operating Results
05/07/2013 | 10:15pm CEST
Company to Host Conference Call Today at 5:00 pm Eastern
Sucampo Pharmaceuticals, Inc. ("Sucampo") (NASDAQ: SCMP), a global
pharmaceutical company with products available in the United States
(U.S.), Japan and Europe, today reported its consolidated financial
results for the first quarter ended March 31, 2013.
Sucampo reported a net loss of $3.1 million, which includes a tax
provision of $1.1 million, or $0.08 per diluted share, for the first
quarter of 2013 compared to a net loss of $1.9 million, or $0.05 per
diluted share, for the first quarter of 2012.
"2013 is off to a strong start for Sucampo," said Ryuji Ueno, M.D.,
Ph.D., Ph.D., Chairman, Chief Executive Officer, and Chief Scientific
Officer of Sucampo. "I am very pleased that we have received approval of
our sNDA for opioid-induced constipation, the third indication for
AMITIZA®,and we will receive a $10 million
milestone payment from our commercial partner in the second quarter.
This quarter we also launched RESCULA® and completed
additional regulatory filings in Europe for AMITIZA, including filings
for OIC in the United Kingdom and Switzerland. We are very pleased with
these successes and are confident that we are on track to meet our
upcoming milestones over the rest of the year."
Quarter Operational Highlights -
As previously reported, on April 23, 2013, Sucampo announced that the
United States Food and Drug Administration (FDA) has approved
Sucampo's supplemental new drug application (sNDA) for AMITIZA
(lubiprostone) (24 mcg twice daily) as the first and only oral
medication for the treatment of opioid-induced constipation (OIC) in
adult patients with chronic, non-cancer pain. Upon the first sale of
AMITIZA for OIC, we will recognize a $10.0 million milestone payment
from Takeda, which we expect to receive in the second quarter of 2013.
In February 2013, Sucampo began commercialization of RESCULA
(unoprostone isopropyl ophthalmic solution) 0.15% for the lowering of
intraocular pressure (IOP) in patients with open-angle glaucoma or
ocular hypertension. Early response to the positioning and messaging
has been positive, and we anticipate prescriptions to steadily
increase over the next few months as we work to pull through patient
samples and expand managed care coverage.
In February 2013, Sucampo completed regulatory filings for an OIC
indication in Switzerland, and in March 2013 we completed filing for
the same indication in the U.K. When we receive approval for OIC in
the U.K., we will seek approval for OIC in other E.U. countries
following the mutual recognition procedure (MRP).
In the first quarter of 2013, we began the MRP to seek approval for
AMITIZA for CIC in additional European Union countries.
Also in the first quarter of 2013, we completed our phase 1a trial of
an oral spray formulation of SPI-8811, or cobiprostone, for the
prevention and/or treatment of oral mucositis. We expect the results
in the second quarter of 2013.
Sucampo initiated a phase 2a trial of SPI-017 in the quarter for the
intravenous treatment of pain associated with severe lumbar spinal
stenosis, and we expect this trial to conclude in the fourth quarter
Progress continues in planning for our phase 3 program for AMITIZA in
functional pediatric constipation.
As previously announced, in February 2013, R-Tech Ueno, Ltd. (R-Tech),
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). In the first quarter of 2013, R-Tech announced the
enrollment of the first patient in this program. Sucampo is
co-developing unoprostone isopropyl with R-Tech and may file for FDA
approval of the product for RP in the future assuming successful trials.
2013 Value Drivers:
Sucampo is pursuing the following value drivers in 2013, of which we
have already achieved four in the first quarter:
Approval of the OIC indication for AMITIZA in the U.S., which has been
achieved. Upon the first sale of AMITIZA for OIC, we will receive a
$10.0 million milestone payment from Takeda, which we anticipate will
be in the second quarter of this year.
Achieve First Patient First Visit in our AMITIZA phase 3 trial for
pediatric functional constipation in the second half of 2013.
Pursue strategic alliances for AMITIZA for new indications and new
territories outside of the U.S., including Europe and several Asian
and emerging markets.
Continued growth of AMITIZA sales.
Submission for regulatory approval in the U.K. and Switzerland of
AMITIZA for the treatment of OIC, which was completed in the first
quarter of 2013. We will continue to work with regulatory authorities
to achieve approval. Once approved in the U.K., we will seek approval
in other European markets for OIC using the mutual recognition
Seek endorsement from NICE for both CIC and OIC in the U.K., and make
AMITIZA available for CIC with reimbursement by some local budget
Begin active marketing of AMITIZA for CIC in Switzerland.
Submission of additional regulatory filings, using the MHRA approval,
to seek expansion of AMITIZA's CIC indication to other European
markets via the MRP.
Launch of RESCULA in the U.S. Following the RESCULA sNDA approval,
Sucampo launched the drug in the U.S. in February. RESCULA is now
available in all major pharmacies, and we continue to see progress in
our efforts to achieve a successful rollout in the U.S.
Completion of our oral mucositis phase 1a trial for cobiprostone in
the second quarter of 2013, which we have achieved, and initiation of
the next trial in the program in the fourth quarter of 2013.
Completion of our spinal stenosis phase 2a trial for SPI-017 in the
fourth quarter of 2013.
Financial Results for the Quarter
For the first quarter of 2013, Sucampo reported total revenue of $16.9
million compared to $14.4 million for the same period in 2012, a growth
of approximately 17%. The key components of revenue for the first
quarter included R&D revenue of $2.8 million, product royalty revenue of
$11.7 million and product sales revenue of $2.2 million in Japan which
compare to $2.6 million, $10.9 million and nil, respectively, in the
same period of 2012.
U.S. net sales of AMITIZA, as reported to us by our partner, Takeda,
increased 7% to $64.9 million for the first quarter of 2013, compared to
$60.7 million in the same period of 2012. The increase in AMITIZA U.S.
net sales was primarily due to both volume and price increases, as
reported to us by our partner.
R&D expenses, comprised of expenses for clinical development of the
AMITIZA pediatric indication, clinical development of the liquid
formulation of AMITIZA, phase 1 trial expenses for oral mucositis, and
clinical development expenses for our lumbar spinal stenosis program,
were $5.6 million for the first quarter of 2013, compared to $3.4
million for the same period of 2012. The increase was primarily due to
the initiation of our phase 3 clinical trial of lubiprostone for
G&A expenses were $7.2 million for the first quarter of 2013, compared
to $7.3 million for the first quarter of 2012. The slight 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 in 2012, partially offset by continued investment in corporate
marketing and branding and staff to support business growth, as well as
pharmacovigilance costs for Japan of $1.0 million.
Selling and marketing expenses were $5.4 million for the first quarter
of 2013, compared to $4.1 million for the first quarter of 2012. The
increase in selling and marketing expenses relates primarily to
commercialization and launch costs for RESCULA, including the
establishment of a Medical and Scientific Affairs department and other
related functions necessary to support the RESCULA launch.
Loss from Operations
For the first quarter of 2013, loss from operations was a loss of $2.6
million, an increase of $2.3 million, compared to a loss of $0.3 million
for the same period in 2012.
Non-Operating Income (Expense)
Non-operating income was $0.6 million for the first quarter of 2013,
compared to income of $0.7 million for the first quarter of 2012. The
first quarter of 2013 included a foreign exchange gain of $1.1 million,
compared to a gain of $1.3 million for the same period of 2012.
Net loss for the first quarter of 2013 was $3.1 million, compared to net
loss of $1.9 million for the same period of 2012.
Comprehensive loss for the first quarter of 2013 was $3.1 million,
compared to comprehensive loss of $3.5 million for the same period in
Cash, Cash Equivalents, Restricted Cash and Marketable Securities
At March 31, 2013, cash, cash equivalents, restricted cash and
investments were $95.8 million, compared to $91.4 million at December
31, 2012. At March 31, 2013, notes payable were $62.4 million, compared
to $52.9 million at December 31, 2012, including current notes payable
of $28.7 million at March 31, 2013, and $19.1 million at December 31,
Stock Repurchase Plan
In September 2011, the Board of Directors (Board) 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 first quarter of 2013, we
repurchased 67,762 shares at a cost of $0.3 million.
In the first quarter of 2013, Timothy Maudlin resigned from the Board of
Directors, Barbara A. Munder and Maureen E. O'Connell were appointed as
class 1 directors, and Dr. Daniel P. Getman resigned as a class 1
director and was appointed as a class 2 director.
Company to Host Conference Call Today
In conjunction with this first 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 877-703-6104
(domestic) or 857-244-7303 (international), and provide the participant
passcode 54089443, 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 30982510.
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 0.12%
(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. RESCULA (unoprostone isopropyl ophthalmic
solution) 0.15% is indicated for the lowering of intraocular pressure
(IOP) in patients with open-angle glaucoma or ocular hypertension in the
About lubiprostone (AMITIZA®)
AMITIZA (lubiprostone) is a prostone, a locally acting chloride channel
activator, indicated for the treatment of CIC in adults and OIC in
adults with chronic, non-cancer pain (24 mcg twice daily) 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 AG. RESCULA is a registered
trademark of R-Tech Ueno, Ltd, and has been licensed to Sucampo AG. The
Sucampo logo and the tagline, The Science of Innovation, are registered
trademarks of 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
(in thousands, except per share data)
Three Months Ended March 31,
Research and development revenue
Product royalty revenue
Contract and collaboration revenue
Product sales revenue
Cost of goods sold
Research and development
General and administrative
Selling and marketing
Total operating expenses
Loss from operations
Non-operating income (expense):
Other income (expense), net
Total non-operating income (expense), net
Income (loss) before income taxes
Income tax benefit (provision)
Net loss per share:
Basic net loss per share
Diluted net loss per share
Weighted average common shares outstanding - basic
Weighted average common shares outstanding - diluted
Other comprehensive income loss:
Unrealized loss on investments, net of tax effect
Foreign currency translation
Sucampo Pharmaceuticals, Inc.
Consolidated Balance Sheets (unaudited)
(in thousands, except share data)
Cash and cash equivalents
Product royalties receivable
Unbilled accounts receivable
Accounts receivable, net
Deferred tax assets, current
Deferred charge, current
Restricted cash, current
Prepaid expenses and other current assets
Total current assets
Property and equipment, net
Intangibles assets, net
Deferred tax assets, non-current
Deferred charge, non-current
Restricted cash, non-current
LIABILITIES AND STOCKHOLDERS' EQUITY:
Deferred revenue, current
Deferred tax liability, current
Income tax payable
Notes payable, current
Other current liabilities
Total current liabilities
Notes payable, non-current
Deferred revenue, non-current
Deferred tax liability, non-current
Preferred stock, $0.01 par value; 5,000,000 shares authorized at
March 31, 2013 and December 31, 2012; no shares issued and
outstanding at March 31, 2013 and December 31, 2012
Class A common stock, $0.01 par value; 270,000,000 shares
authorized at March 31, 2013 and December 31, 2012; 41,965,689 and
41,964,905 shares issued and outstanding at March 31, 2013 and
December 31, 2012, respectively
Additional paid-in capital
Accumulated other comprehensive income
Treasury stock, at cost; 524,792 and 457,030 shares