Sucampo Pharmaceuticals, Inc. Reports First Quarter 2013 Financial and
Company to Host Conference Call Today at 5:00 pm Eastern
BETHESDA, Md. -- May 07, 2013
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 of
*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
*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 procedure.
*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 holders.
*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
*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
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 pediatric patients.
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 2012.
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, 2012.
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 United States.
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
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
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 March 31,
Research and development revenue $ 2,800 $ 2,585
Product royalty revenue 11,677 10,928
Co-promotion revenue 61 766
Contract and collaboration revenue 164 167
Product sales revenue 2,217 -
Total revenues 16,919 14,446
Cost of goods sold 1,282 -
Gross profit 15,637 14,446
Research and development 5,629 3,352
General and administrative 7,227 7,327
Selling and marketing 5,389 4,089
Total operating expenses 18,245 14,768
Loss from operations (2,608 ) (322 )
Non-operating income (expense):
Interest income 19 20
Interest expense (495 ) (592 )
Other income (expense), net 1,081 1,274
Total non-operating income (expense), net 605 702
Income (loss) before income taxes (2,003 ) 380
Income tax benefit (provision) (1,142 ) (2,308 )
Net loss $ (3,145 ) $ (1,928 )
Net loss per share:
Basic net loss per share $ (0.08 ) $ (0.05 )
Diluted net loss per share $ (0.08 ) $ (0.05 )
Weighted average common shares outstanding - 41,461 41,702
Weighted average common shares outstanding - 41,461 41,702
Net loss $ (3,145 ) $ (1,928 )
Other comprehensive income loss:
Unrealized loss on investments, net of tax (14 ) (3 )
Foreign currency translation 51 (1,592 )
Comprehensive loss $ (3,108 ) $ (3,523 )
Sucampo Pharmaceuticals, Inc.
Consolidated Balance Sheets (unaudited)
(in thousands, except share data)
March 31, December 31,
Cash and cash equivalents $ 48,643 $ 52,022
Investments, current 5,142 6,035
Product royalties receivable 11,677 14,175
Unbilled accounts receivable 166 732
Accounts receivable, net 1,841 1,360
Deferred tax assets, current 693 874
Deferred charge, current 673 673
Restricted cash, current 26,113 15,113
Inventory 3,958 -
Prepaid expenses and other current assets 2,694 1,930
Total current assets 101,600 92,914
Investments, non-current 13,614 14,408
Property and equipment, net 1,502 1,540
Intangibles assets, net 7,171 7,415
Deferred tax assets, non-current 1,391 1,654
Deferred charge, non-current 5,045 5,213
Restricted cash, non-current 2,319 3,832
Other assets 709 820
Total assets $ 133,351 $ 127,796
LIABILITIES AND STOCKHOLDERS' EQUITY:
Accounts payable $ 9,256 $ 5,496
Accrued expenses 7,845 10,595
Deferred revenue, current 941 3,700
Deferred tax liability, current 70 -
Income tax payable 957 148
Notes payable, current 28,729 19,129
Other current liabilities 1,458 1,003
Total current liabilities 49,256 40,071
Notes payable, non-current 33,722 33,722
Deferred revenue, non-current 6,722 7,093
Deferred tax liability, non-current 2,438 2,627
Other liabilities 1,210 1,253
Total liabilities 93,348 84,766
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 41,964,905 420 420
shares issued and outstanding at March 31, 2013
and December 31, 2012, respectively
Additional paid-in capital 62,938 62,521
Accumulated other comprehensive income 16,203 16,166
Treasury stock, at cost; 524,792 and 457,030 (2,313 ) (1,977 )
Accumulated deficit (37,245 ) (34,100 )
Total stockholders' equity 40,003 43,030
Total liabilities and stockholders' equity $ 133,351 $ 127,796
Key Segment Information (unaudited)
(In thousands) Americas Europe Asia Consolidated
Three Months Ended
March 31, 2013
Research and $ 2,800 $ - $ - $ 2,800
Product royalty 11,677 - - 11,677
Product sales 1 8 2,208 2,217
Co-promotion revenue 61 - - 61
collaboration 141 12 11 164
Total revenues 14,680 20 2,219 16,919
Cost of goods sold 23 5 1,254 1,282
Gross profit 14,657 15 965 15,637
Research and 1,282 2,671 1,676 5,629
Depreciation and 122 250 9 381
Other operating 10,317 598 1,320 12,235
Income (loss) from 2,936 (3,504 ) (2,040 ) (2,608 )
Interest income 15 4 - 19
Interest expense - (460 ) (35 ) (495 )
Other non-operating (16 ) (192 ) 1,289 1,081
Income (loss) before $ 2,935 $ (4,152 ) $ (786 ) $ (2,003 )
Capital expenditures $ 14 $ 103 $ 3 $ 120
Three Months Ended
March 31, 2012
Research and $ 2,479 $ 3 $ 103 $ 2,585
Product royalty 10,928 - - 10,928
Co-promotion revenue 766 - - 766
collaboration 141 13 13 167
Total revenues 14,314 16 116 14,446
Cost of goods sold - - - -
Gross profit 14,314 16 116 14,446
Research and 822 1,517 1,013 3,352
Depreciation and 120 220 10 350
Other operating 10,053 716 297 11,066
Income (loss) from 3,319 (2,437 ) (1,204 ) (322 )
Interest income 18 2 - 20
Interest expense - (550 ) (42 ) (592 )
Other non-operating 75 190 1,009 1,274
Income (loss) before $ 3,412 $ (2,795 ) $ (237 ) $ 380
Capital expenditures $ 40 $ - $ - $ 40
Sucampo Pharmaceuticals, Inc.
Silvia Taylor, 1-240-223-3718
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