Results Driven by Continued AMITIZA
Growth and R-TECH UENO Acquisition
Sucampo Pharmaceuticals, Inc. (Sucampo) (NASDAQ:SCMP), a global
biopharmaceutical company, today reported consolidated financial
results for the fourth quarter and full year ended December 31,
2015. Financial results include consolidated operations from
R-Tech Ueno as of October 21, 2015.
Summary of Results |
Q4-15 |
% Increase onQ4-14 |
FY-15 |
% increase
onFY-14 |
Revenue |
$55.4 M |
|
47 |
% |
$153.2 M |
|
33 |
% |
Net Income GAAP |
$10.2 M |
|
9 |
% |
$33.4 M |
|
154 |
% |
EPS GAAP - diluted |
$ |
0.23 |
|
|
11 |
% |
$ |
0.73 |
|
|
152 |
% |
EBITDA |
$25.1 M |
|
40 |
% |
$60.5 M |
|
72 |
% |
Adjusted Net Income |
$19.1 M |
|
105 |
% |
$43.5 M |
|
143 |
% |
Adjusted EPS - diluted |
$ |
0.43 |
|
|
108 |
% |
$ |
0.95 |
|
|
136 |
% |
Adjusted EBITDA |
$27.7 M |
|
46 |
% |
$69.9 M |
|
86 |
% |
|
“Sucampo ended 2015 with incredibly positive
momentum, demonstrating exceptional financial results and already
generating significant value from the R-Tech Ueno
acquisition. I am proud that we achieved all of our goals for
the year, driving solid top- and bottom-line growth, focusing on
the advancement and diversification of our pipeline, and improving
our capital structure,” said Peter Greenleaf, Chairman and Chief
Executive Officer of Sucampo. “We have made a strong start to
2016, with AMITIZA demonstrating continued growth, streamlined
operations from our continued integration with R-Tech Ueno, a
recently strengthened balance sheet, and an exciting agreement
signed for the exclusive option to license a novel, orphan disease
gastrointestinal product. Priorities in 2016 remain executing
on additional high-quality acquisitions that will be accretive as
well as continuing to diversify our pipeline.”
For the three months ended December 31, 2015,
Sucampo reported year-over-year growth of 47% to $55.4 million in
total revenue. Revenue for the quarter included an additional
$11.8 million as a result of the R-Tech Ueno acquisition. Excluding
this additional revenue, as well as a $5 million milestone payment
earned in the fourth quarter of 2015, an $8 million milestone
payment earned in the fourth quarter of 2014, and the effect of
co-promotion revenue ceasing in 2014, base revenue grew by
36%. Product sales revenue increased to $29.6 million,
representing 285% year-over-year growth, and product royalty
revenue grew 23% year-over-year to $22.9 million.
Sucampo reported adjusted net income of $19.1
million, or $0.43 per diluted share, during the fourth quarter of
2015, compared to adjusted net income of $9.3 million and diluted
EPS of $0.21 in the same period in 2014, an increase of 105%. On a
GAAP basis, Sucampo reported net income of $10.2 million and
diluted EPS of $0.23 during the fourth quarter of 2015, compared to
net income of $9.3 million and diluted EPS of $0.21 in the same
period in 2014, an increase of 9%.
For the full year 2015, Sucampo reported
year-over-year growth of 33% to $153.2 million in total revenue,
including one time milestone payments and the effect of
co-promotion efforts ceasing in 2014. Excluding revenue from
the R-Tech Ueno acquisition, total revenue grew 23%.
For the full year 2015, Sucampo reported
adjusted net income of $43.5 million and adjusted diluted EPS of
$0.95, compared to adjusted net income of $17.9 million and
adjusted diluted EPS of $0.40 in the full year 2014, an increase of
143%. On a GAAP basis, Sucampo reported net income of $33.4 million
and diluted EPS of $0.73 during the full year 2015, compared to net
income of $13.1 million and diluted EPS of $0.29 in the same period
in 2014, an increase of 154%.
Fourth Quarter 2015 Operational
Review
AMITIZA
United States
- AMITIZA total prescriptions were 390,228 in the fourth quarter
of 2015, an increase of 10% compared to the fourth quarter of 2014.
Net sales of AMITIZA, reported by Takeda Pharmaceuticals U.S.A.,
Inc. (Takeda) for royalty calculation purposes, increased 13% to
$102.3 million for the fourth quarter of 2015, compared to $91.1
million in the same period of 2014. Royalty revenue was $22.9
million compared to $18.6 million for the fourth quarter of 2014,
an increase of 23%. Also included in fourth quarter revenue are
Takeda AMITIZA sales from R-Tech Ueno of $10.4 million. For
the full year 2015, AMITIZA total prescriptions were 1,475,634, an
increase of 10% compared to the full year of 2014. Net sales of
AMITIZA reported by Takeda for royalty calculation purposes,
increased 15% to $380.4 million for the full year of 2015, compared
to $331.6 million in the same period of 2014. Royalty revenue for
the full year 2015 was $74.1 million compared to $62.8 million for
full year 2014, an increase of 18%.
Global Markets
- In Japan, Sucampo's revenue from sales of AMITIZA to Mylan N.V.
increased 74% to $12.9 million for the fourth quarter of 2015,
compared to $7.4 million in the same period of 2014. For the full
year, revenue from sales of AMITIZA to Mylan N.V. increased 64% to
$48.9 million, compared to $29.9 million in 2014. Sucampo earned a
$5.0 million milestone payment from Mylan pursuant to the existing
license, commercialization and supply agreement in the fourth
quarter of 2015. The milestone payment was triggered by the first
occurrence of annual net sales of lubiprostone for chronic
constipation (CC) in Japan exceeding JPY 10.0 billion. Full year
2014 included a $2.5 million milestone payment from Mylan in the
third quarter (then Abbott Japan Co., Ltd.)
Corporate
- In December 2015, Sucampo completed its acquisition of R-Tech
Ueno for 32.8 billion Japanese Yen (JPY), or approximately $275
million. Through the acquisition, Sucampo secured a larger portion
of the global economics of AMITIZA, greater control over the
manufacturing and supply chain for the product, and acquired new
product candidates, including two vascular adhesion protein
inhibitors.
- In October 2015, Sucampo closed a $250.0 million credit
facility in connection with the financing of its acquisition of
R-Tech Ueno. The loans under the credit facility were fully
allocated to institutional investors. The loans under the credit
facility bear interest at a LIBOR (subject to a 1% floor) plus
7.25% or base rate (subject to a 2% floor) plus 6.25% and have a
final maturity date of October 16, 2021.
- In October 2015, Timothy P. Walbert joined Sucampo’s Board of
Directors. Mr. Walbert currently serves as Chairman, President and
Chief Executive Officer of Horizon Pharma plc.
- In January 2016, Sucampo completed an option and collaboration
agreement under which Cancer Prevention Pharmaceuticals, Inc. (CPP)
has granted Sucampo the sole option to acquire an exclusive license
to commercialize the combination product CPP-1X/sulindac in North
America. This product is currently in a phase 3 clinical trial for
the treatment of familial adenomatous polyposis (FAP), which has
been designated as an orphan indication in the United States and
Europe. Enrollment in the study is expected to be complete in the
first half of 2016 and the trial is expected to conclude in 2018,
with potential for approval as early as 2019.
- In January 2016, Peter Greenleaf, Sucampo’s Chief Executive
Officer, was appointed Chairman of the Board of Directors.
Concurrently, John Johnson was appointed the lead independent
director.
Fourth Quarter and Full Year 2015
Financial Review
- Adjusted net income was $19.1 million, or $0.43 per diluted
share, during the fourth quarter of 2015, compared to adjusted net
income of $9.3 million and diluted EPS of $0.21 in the same period
in 2014, an increase of 105%. On a GAAP basis, Sucampo reported net
income of $10.2 million and diluted EPS of $0.23 during the fourth
quarter of 2015, compared to net income of $9.3 million and diluted
EPS of $0.21 in the same period in 2014, an increase of 9%.
- For the full year 2015, Sucampo reported adjusted net income of
$43.5 million and adjusted diluted EPS of $0.95, compared to
adjusted net income of $17.9 million and adjusted diluted EPS of
$0.40 in the full year 2014, an increase of 143%. On a GAAP basis,
Sucampo reported net income of $33.4 million and diluted EPS of
$0.73 during the full year 2015, compared to net income of $13.1
million and diluted EPS of $0.29 in the same period in 2014, an
increase of 154%.
- Adjusted EBITDA, defined as net income before interest, taxes,
depreciation, amortization, stock-based compensation expense,
restructuring and intangible impairment, was $27.7 million for the
fourth quarter of 2015 compared to $18.9 million in the same period
in 2014, an increase of 46%. For the full year of 2015, adjusted
EBITDA was $69.9 million compared to $37.5 million in 2014, an
increase of 86%.
- Total revenues were $55.4 million for the fourth quarter of
2015 compared to $37.8 million in the same period in 2014, an
increase of $17.6 million or 47%. The increase was primarily due to
the $11.8 million inclusion of R-Tech Ueno results, a milestone
payment received from Mylan and higher AMITIZA sales in the US and
Japan, offset by an upfront payment received during Q2 2014 under
the Global Takeda agreement. For the full year 2015, total revenues
were $153.2 million compared to $115.5 million for the full year
2014, an increase of $37.7 million or 33%.
- Costs of goods sold were $18.1 million for the fourth quarter
of 2015 compared to $4.1 million for the same period in 2014, an
increase of $14.0 million or 340%. The increase was primarily due
to the inclusion of R-Tech Ueno results, which included the step up
of inventory and intangible asset amortization of $9.4 million,
coupled with an increase in product sales. Excluding the step up of
inventory and intangible asset amortization of $9.4 million, cost
of goods sold was $8.7 million. For the full year 2015, cost
of goods sold was $36.7 million compared to $16.3 million for the
full year 2014, an increase of $20.4 million. The increase
was primarily due to the inclusion of R-Tech Ueno results, which
included the step up of inventory and intangible asset amortization
of $9.4 million, coupled with an increase in product sales.
Excluding the step up of inventory and intangible asset
amortization of $9.4 million, cost of goods sold was $27.3 million,
an increase of 67%.
- Gross Margin, calculated as product sales revenue, less cost of
goods sold, as a percentage of product sales revenue, was 39% for
the fourth quarter of 2015 compared to 47% for the same period in
2014, a decrease of 8%. The decrease was primarily due to the step
up of inventory and intangible asset amortization, offset by the
Mylan sales milestone. Excluding the step up of inventory and
intangible asset amortization and the Japan Mylan milestone, gross
margin was 54%, an increase of 7%. For the full year 2015, gross
margin was 45% compared to 51% for the full year 2014, a decrease
of 6%. The decrease was primarily due to the inclusion of R
Tech Ueno, which included the step up of inventory and intangible
asset amortization, offset by the Mylan sales milestone. Excluding
the step up of inventory and intangible asset amortization and the
Japan Mylan milestone, gross margin was 51%, an increase of
7%.
- Research and development expenses were $11.3 million for the
fourth quarter of 2015 compared to $5.9 million for the same period
of 2014, an increase of $5.4 million or 93%. The increase quarter
over quarter was primarily due to the inclusion of R-Tech Ueno in
Q4, coupled with ongoing development efforts related to
lubiprostone for prediatric functional constipation, oral mucositis
and non-erosive reflux disease / symptomatic gastroesophageal
reflux disease (NERD / sGERD). For the full year 2015,
research and development expenses were $33.6 million compared to
$20.6 million for the full year 2014, an increase of $13.1 million
or 64%. The increase year over year, was primarily due to the
inclusion of R-Tech Ueno in Q4, coupled with ongoing development
efforts related to Lubiprostone for Prediatric Functional
Constipation, oral mucositis and NERD / sGERD.
- General and administrative expenses were $13.2 million for the
fourth quarter of 2015 compared to $7.7 million for the same period
of 2014, an increase of $5.5 million or 72%. The increase was
primarily due to R-Tech Ueno acquisition costs. For the full year
2015, general and administrative expenses were $35.5 million
compared to $31.2 million for the full year 2014, an increase of
$4.3 million or 14%. The fluctuation year over year is
primarily due to the acquisition of R-Tech Ueno in Q4 and the
inclusion of the underlying acquisition costs.
- Selling and marketing expenses were $1.2 million for the fourth
quarter of 2015 compared to $3.1 million for the same period of
2014, a decrease of $1.9 million or 60%. The decrease was primarily
due to the reduction in our direct commercial operations in the
U.S. and Europe in the fourth quarter of 2014. For the full
year 2015, selling and marketing expenses were $2.8 million
compared to $14.5 million for the full year 2014, a decrease of
$11.7 million or 80%.
- The effective tax rate for the fourth quarter of 2015 was a
negative 7%, compared to 48% in the same period of 2014. The
reduction in the tax rate is due to the timing of the allowable
deduction for intangible impairment expense, the timing and
recognition of uncertain tax positions, together with the effect on
the treatment of non-U.S. income following the reduction in
holdings of Sucampo’s founding stockholders below 50% of Sucampo’s
outstanding shares, which occurred in the first quarter of 2015,
offset by the timing and deductibility of transaction related
costs. The effective tax rate for the full year 2015 was 24%,
compared to 52% for the full year 2014. The reduction in the
full year tax rate is driven by the same factors that impacted the
Q4 tax rate.
Certain prior year Non GAAP amounts have
been reclassified for consistency with the current period adjusted
presentation. These reclassifications had no effect on the reported
results of operations. A reconciliation of
adjusted Net Income to GAAP Net Income and adjusted EBITDA to
income from operations, the most directly comparable GAAP financial
measure, is included in the tables below.
|
|
RECONCILIATION OF GAAP NET LOSS TO NON-GAAP
NET INCOME |
|
(in thousands, except per share
amounts) |
|
|
|
|
|
|
Three MonthsEnded |
Three MonthsEnded |
For the YearEnded |
For the YearEnded |
|
December 31, 2015 |
December 31, 2014 |
December 31,2015 |
December 31,2014 |
Adjusted
Non-GAAP Net Income: |
|
|
|
|
GAAP Net
Income |
|
10,151 |
|
9,283 |
|
33,371 |
|
|
13,128 |
|
Non-GAAP Adjustments: |
|
|
|
|
Intangible Asset Impairment |
|
- |
|
- |
|
- |
|
|
5,631 |
|
Amortization of Acquired
Intangibles |
|
3,732 |
|
- |
|
3,732 |
|
|
- |
|
Amortization Inventory Step Up
Adjustment |
|
5,645 |
|
- |
|
5,645 |
|
|
- |
|
Restructuring Costs |
|
958 |
|
- |
|
958 |
|
|
- |
|
Acqusition Related Expenses |
|
3,914 |
|
|
|
5,135 |
|
|
Amortization of Debt Financing
Costs |
|
870 |
|
- |
|
870 |
|
|
- |
|
Acceleration of Deferred
Revenue |
|
(4,079 |
) |
- |
|
(4,079 |
) |
|
- |
|
Tax Effect of Adjustments |
|
(2,119 |
) |
- |
|
(2,119 |
) |
|
(829 |
) |
Total Non-GAAP Adjustments |
|
8,921 |
|
- |
|
10,142 |
|
|
4,802 |
|
Adjusted Non-GAAP Net
Income |
|
19,072 |
|
9,283 |
|
43,513 |
|
|
17,930 |
|
|
|
|
|
|
Weighted Average Shares -
Basic |
|
|
|
|
|
|
|
|
|
Adjusted Non-GAAP Net
Income Per Share - Basic |
|
42,885 |
|
43,921 |
|
44,150 |
|
|
43,691 |
|
GAAP Net Income per Share -
Basic |
|
0.24 |
|
0.21 |
|
0.76 |
|
|
0.30 |
|
Non-GAAP Adjustments |
|
0.21 |
|
- |
|
0.23 |
|
|
0.11 |
|
Adjusted Non-GAAP Net
Income per Share - Basic |
|
0.44 |
|
0.21 |
|
0.99 |
|
|
0.41 |
|
|
|
|
|
|
Weighted Average Shares -
Diluted |
|
|
|
|
|
|
|
|
|
Adjusted Non-GAAP Net
Income Per Share - Diluted |
|
44,338 |
|
44,917 |
|
45,680 |
|
|
44,506 |
|
GAAP Net Income per Share -
Diluted |
|
0.23 |
|
0.21 |
|
0.73 |
|
|
0.29 |
|
Non-GAAP Adjustments |
|
0.20 |
|
0.00 |
|
0.22 |
|
|
0.11 |
|
Adjusted Non-GAAP Net
Income per Share - Diluted |
|
0.43 |
|
0.21 |
|
0.95 |
|
|
0.40 |
|
|
|
|
|
|
|
|
|
|
|
|
RECONCILIATION OF INCOME FROM OPERATIONS TO
ADJUSTED EBITDA |
|
(in thousands, except per share
amounts) |
|
|
|
|
|
|
Three MonthsEnded |
Three MonthsEnded |
For the YearEnded |
For the YearEnded |
|
December 31, 2015 |
December 31, 2014 |
December 31,2015 |
December 31,2014 |
GAAP Net
Income |
|
10,151 |
|
9,283 |
|
33,371 |
|
|
13,128 |
|
Adjustments: |
|
|
|
|
Taxes |
|
(684 |
) |
8,306 |
|
10,304 |
|
|
14,005 |
|
Interest expense |
|
6,070 |
|
279 |
|
6,854 |
|
|
1,348 |
|
Depreciation |
|
221 |
|
111 |
|
623 |
|
|
1,090 |
|
Intangible Asset Impairment |
|
- |
|
- |
|
- |
|
|
5,631 |
|
Amortization of Acquired
Intangibles |
|
3,732 |
|
- |
|
3,732 |
|
|
- |
|
Amortization Inventory Step Up
Adjustment |
|
5,645 |
|
- |
|
5,645 |
|
|
- |
|
EBITDA |
|
25,135 |
|
17,979 |
|
60,530 |
|
|
35,202 |
|
Non-GAAP Adjustments: |
|
|
|
|
Share Based Compensation
Expense |
|
1,742 |
|
908 |
|
7,349 |
|
|
2,287 |
|
Restructuring Costs |
|
958 |
|
- |
|
958 |
|
|
- |
|
Acqusition Related Expenses |
|
3,914 |
|
- |
|
5,135 |
|
|
- |
|
Acceleration of Deferred
Revenue |
|
(4,079 |
) |
- |
|
(4,079 |
) |
|
- |
|
Total Non-GAAP Adjustments |
|
2,534 |
|
908 |
|
9,363 |
|
|
2,287 |
|
Adjusted
EBITDA |
|
27,669 |
|
18,887 |
|
69,892 |
|
|
37,489 |
|
|
RECONCILIATION OF GAAP GROSS MARGIN TO
NON-GAAP GROSS MARGIN |
|
|
|
|
|
|
|
|
|
|
|
Three MonthsEndedDecember
31,2015 |
|
Three MonthsEndedDecember
31,2014 |
|
For the YearEndedDecember
31,2015 |
|
For the YearEndedDecember
31,2014 |
|
|
|
|
|
|
|
% |
% |
% |
% |
Gross
Margin |
|
|
|
|
|
|
|
|
Product Sales |
|
29,598 |
|
|
100 |
% |
|
7,680 |
|
|
100 |
% |
|
66,276 |
|
|
100 |
% |
|
33,252 |
|
|
100 |
% |
COGS |
|
(18,075 |
) |
|
-61 |
% |
|
(4,106 |
) |
|
-53 |
% |
|
(36,731 |
) |
|
-55 |
% |
|
(16,269 |
) |
|
-49 |
% |
GAAP Gross
Margin |
|
11,523 |
|
|
39 |
% |
|
3,574 |
|
|
47 |
% |
|
29,545 |
|
|
45 |
% |
|
16,983 |
|
|
51 |
% |
Non-GAAP Adjustments: |
|
|
|
|
|
|
|
|
Amortization of Acquired
Intangibles |
|
3,732 |
|
|
13 |
% |
|
- |
|
|
0 |
% |
|
3,732 |
|
|
6 |
% |
|
- |
|
|
0 |
% |
Amortization Inventory Step Up |
|
5,645 |
|
|
19 |
% |
|
- |
|
|
0 |
% |
|
5,645 |
|
|
9 |
% |
|
- |
|
|
0 |
% |
Mylan Milestone Payments |
|
(5,000 |
) |
|
-17 |
% |
|
- |
|
|
0 |
% |
|
(5,000 |
) |
|
-8 |
% |
|
(2,500 |
) |
|
-8 |
% |
Adjusted Non-GAAP Gross
Margin |
|
15,900 |
|
|
54 |
% |
|
3,574 |
|
|
47 |
% |
|
33,922 |
|
|
51 |
% |
|
14,483 |
|
|
44 |
% |
|
Cash, Cash Equivalents, Restricted Cash
and Marketable Securities
At December 31, 2015, cash, cash equivalents,
restricted cash and investments were $163.5 million compared to
$110.0 million at December 31, 2014. At December 31, 2015 and
December 31, 2014, notes payable were $252.4 million and $25.8
million, respectively, including current portions of $39.1 million
and $8.2 million, respectively. The increase in notes payable is
primarily due to the $250.0 million credit facility closed during
the fourth quarter of 2015. Sucampo’s net debt position at
December 31, 2015 is approximately $104.1 million.
Guidance
Sucampo today reiterated its earnings guidance
for the full year ending December 31, 2016. Sucampo expects total
revenue of $195.0 million to $205.0 million, adjusted net income of
$45.0 million to $50.0 million, adjusted EPS of $0.97 to $1.07, and
adjusted EBITDA of $100.0 million to $105.0 million. Adjusted net
income guidance excludes amortization of acquired intangibles of
approximately $17.6 million and amortization of the remaining
inventory step-up costs of approximately $8.9 million.
Non-GAAP Financial Measures
This press release contains non-GAAP earnings as
listed in the first table above, which is GAAP net income before
interest, tax, depreciation, amortization, stock option expense and
intangible impairment. Sucampo believes that this non-GAAP measure
of financial results provides useful information to management and
investors relating to its results of operations. Sucampo's
management uses this non-GAAP measure to compare Sucampo's
performance to that of prior periods for trend analyses, and for
budgeting and planning purposes. Sucampo believes that the use of
non-GAAP financial measures provides an additional tool for
investors to use in evaluating ongoing operating results and trends
and in comparing the Sucampo's financial measures with other
companies in its industry, many of which present similar non-GAAP
financial measures to investors, and that it allows for greater
transparency with respect to key metrics used by management in its
financial and operational decision-making.
Management of the company does not consider
non-GAAP measures in isolation or as an alternative to financial
measures determined in accordance with GAAP. The principal
limitation of non-GAAP financial measures is that they exclude
significant expenses that are required by GAAP to be recorded in
the Sucampo's financial statements. In order to compensate for
these limitations, management presents non-GAAP financial measures
together with GAAP results. Non-GAAP measures should be considered
in addition to results and guidance prepared in accordance with
GAAP, but should not be considered a substitute for, or superior
to, GAAP results. Reconciliation tables of the most comparable GAAP
financial measure to the non-GAAP financial measure used in this
press release are included with the financial tables at the end of
this release. Sucampo urges investors to review the reconciliation
and not to rely on any single financial measure to evaluate the
Sucampo's business. In addition, other companies, including
companies in our industry, may calculate similarly named non-GAAP
measures differently than we do, which limits their usefulness in
comparing our financial results with theirs.
Company to Host Conference Call
Today
Sucampo will host a conference call and webcast
today at 8:30 am EST. To participate on the live call, please dial
866-383-8009 (domestic) or 617-597-5342 (international) and use
passcode 10562705, 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), passcode
24339412. Investors interested in accessing the live audio webcast
of the teleconference may do so at
http://www.sucampo.com/investors/events-presentations/ 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 AMITIZA®
(lubiprostone)
AMITIZA (lubiprostone) is a chloride channel
activator that acts locally in the small intestine. By increasing
intestinal fluid secretion, lubiprostone increases motility in the
intestine, thereby facilitating the passage of stool and
alleviating symptoms associated with CIC. Lubiprostone, via
activation of apical CIC-2 channels in intestinal epithelial cells,
bypasses the antisecretory action of opiates that results from
suppression of secretomotor neuron excitability. Activation of
CIC-2 by lubiprostone has also been shown to stimulate recovery of
mucosal barrier function and reduce intestinal permeability via the
restoration of tight junction protein complexes in ex vivo studies
of ischemic porcine intestine.
AMITIZA (24 mcg twice daily) is indicated in the
U.S. for the treatment of adults with CIC and opioid-induced
constipation (OIC) with chronic, non-cancer pain. AMITIZA (8 mcg
twice daily) is also approved in the U.S. for irritable bowel
syndrome with constipation (IBS-C) in women 18 years of age and
older. In Japan, AMITIZA (24 mcg twice daily) is indicated for the
treatment of chronic constipation (excluding constipation caused by
organic diseases). In Canada, AMITIZA (24 mcg twice daily) is
indicated for the treatment of CIC in adults. In the U.K., AMITIZA
(24 mcg twice daily) is indicated for the treatment of CIC and
associated symptoms in adults, when response to diet and other
non-pharmacological measures (e.g. educational measures, physical
activity) are inappropriate. In Switzerland, AMITIZA (24 mcg twice
daily) is indicated for the treatment of CIC in adults and for the
treatment of OIC and associated signs and symptoms such as stool
consistency, straining, constipation severity, abdominal
discomfort, and abdominal bloating in adults with chronic,
non-cancer pain. The efficacy of AMITIZA for the treatment of OIC
in patients taking opioids of the diphenylheptane class, such as
methadone, has not been established.
About RESCULA®
Unoprostone isopropyl 0.12% (trade named
RESCULA) first received marketing authorization in 1994 in Japan
for the treatment of glaucoma and ocular hypertension.
RESCULA is marketed in Japan by Santen Pharmaceutical Co., Ltd.
(Santen). We acquired RESCULA as part of the acquisition of
R-Tech Ueno in 2015.
About Sucampo Pharmaceuticals,
Inc.
Sucampo Pharmaceuticals, Inc. is focused on the
development and commercialization of medicines that meet major
unmet medical needs of patients worldwide. Sucampo has two marketed
products – AMITIZA, its lead product, and RESCULA – and a pipeline
of product candidates in clinical development. A global company,
Sucampo is headquartered in Rockville, Maryland, and has operations
in Japan, Switzerland and the U.K. For more information, please
visit www.sucampo.com.
The Sucampo logo and the tagline, The Science of
Innovation, are registered trademarks of Sucampo AG. AMITIZA is a
registered trademark of Sucampo AG.
Follow us on Twitter (@Sucampo_Pharma). Follow
us on LinkedIn (Sucampo Pharmaceuticals).
Twitter LinkedIn
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 financial results for the full
years ending December 31, 2015 and 2016, as well as statements
about potential future revenue growth, statements regarding the
acquisition of R-Tech Ueno and the integration of its business and
operations with that of Sucampo, and statements regarding product
development, 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; the ability of Sucampo to continue to develop the
market for AMITIZA; the ability of Sucampo to develop,
commercialize or license existing pipeline products or compounds or
license or acquire non-prostone products or drug candidates;
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; the
effects of competitive products on Sucampo’s products; risks
relating to Sucampo's financing for the R-Tech Ueno acquisition,
including the restrictive covenants undertaken by Sucampo as part
of the financing; Sucampo’s ability to successfully integrate
R-Tech Ueno Ueno’s operations; 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
press release 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 10-K as filed with the Securities and
Exchange Commission on March 9, 2015 as well as its filings with
the Securities and Exchange Commission on Forms 8-K and 10-Q since
the filing of the Form 10-K, all of 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 December 31, |
|
Year Ended December 31, |
|
|
2015 |
|
|
|
2014 |
|
|
|
2015 |
|
|
|
2014 |
|
|
|
|
|
|
|
|
|
Revenues: |
|
|
|
|
|
|
|
Product royalty revenue |
$ |
22,929 |
|
|
$ |
18,575 |
|
|
$ |
74,138 |
|
|
$ |
62,775 |
|
Product sales revenue |
|
29,598 |
|
|
|
7,680 |
|
|
|
66,276 |
|
|
|
33,252 |
|
Research and development
revenue |
|
2,731 |
|
|
|
1,965 |
|
|
|
10,199 |
|
|
|
7,246 |
|
Contract and collaboration
revenue |
|
110 |
|
|
|
8,198 |
|
|
|
2,567 |
|
|
|
8,817 |
|
Co-promotion revenue |
|
- |
|
|
|
1,339 |
|
|
|
- |
|
|
|
3,360 |
|
Total revenues |
|
55,368 |
|
|
|
37,757 |
|
|
|
153,180 |
|
|
|
115,450 |
|
|
|
|
|
|
|
|
|
Costs and
expenses: |
|
|
|
|
|
|
|
Costs of goods sold |
|
18,075 |
|
|
|
4,106 |
|
|
|
36,731 |
|
|
|
16,269 |
|
Intangible assets impairment |
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
5,631 |
|
Research and development |
|
11,346 |
|
|
|
5,882 |
|
|
|
33,631 |
|
|
|
20,566 |
|
General and administrative |
|
13,154 |
|
|
|
7,659 |
|
|
|
35,517 |
|
|
|
31,230 |
|
Selling and marketing |
|
1,225 |
|
|
|
3,062 |
|
|
|
2,842 |
|
|
|
14,523 |
|
Total costs and expenses |
|
43,800 |
|
|
|
20,709 |
|
|
|
108,721 |
|
|
|
88,219 |
|
|
|
|
|
|
|
|
|
Income from
operations |
|
11,568 |
|
|
|
17,048 |
|
|
|
44,459 |
|
|
|
27,231 |
|
Non-operating income
(expense): |
|
|
|
|
|
|
|
Interest income |
|
26 |
|
|
|
66 |
|
|
|
181 |
|
|
|
172 |
|
Interest expense |
|
(6,070 |
) |
|
|
(344 |
) |
|
|
(6,854 |
) |
|
|
(1,520 |
) |
Other income, net |
|
3,942 |
|
|
|
1,107 |
|
|
|
5,889 |
|
|
|
1,250 |
|
Total non-operating income
(expense), net |
|
(2,102 |
) |
|
|
829 |
|
|
|
(784 |
) |
|
|
(98 |
) |
|
|
|
|
|
|
|
|
Income before income
taxes |
|
9,466 |
|
|
|
17,877 |
|
|
|
43,675 |
|
|
|
27,133 |
|
Income tax
provision |
|
685 |
|
|
|
(8,594 |
) |
|
|
(10,304 |
) |
|
|
(14,005 |
) |
Net income |
$ |
10,151 |
|
|
$ |
9,283 |
|
|
$ |
33,371 |
|
|
$ |
13,128 |
|
|
|
|
|
|
|
|
|
Net income per
share: |
|
|
|
|
|
|
|
Basic |
$ |
0.24 |
|
|
$ |
0.21 |
|
|
$ |
0.76 |
|
|
$ |
0.30 |
|
Diluted |
$ |
0.23 |
|
|
$ |
0.21 |
|
|
$ |
0.73 |
|
|
$ |
0.29 |
|
Weighted average common
shares outstanding: |
|
|
|
|
|
|
|
|
|
Basic |
|
42,885 |
|
|
|
43,921 |
|
|
|
44,150 |
|
|
|
43,691 |
|
Diluted |
|
44,338 |
|
|
|
44,917 |
|
|
|
45,680 |
|
|
|
44,506 |
|
|
Sucampo Pharmaceuticals, Inc. |
Consolidated Balance Sheets (unaudited) |
(in
thousands, except share and per share data) |
|
|
December 31, |
|
|
2015 |
|
|
|
2014 |
|
ASSETS: |
|
|
|
|
|
|
|
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
108,284 |
|
|
$ |
71,622 |
|
Investments, current |
|
- |
|
|
|
22,393 |
|
Product royalties receivable |
|
22,792 |
|
|
|
18,576 |
|
Accounts receivable, net |
|
22,759 |
|
|
|
5,338 |
|
Deferred charge, current |
|
295 |
|
|
|
295 |
|
Restricted cash, current |
|
55,218 |
|
|
|
213 |
|
Inventories, net |
|
33,121 |
|
|
|
- |
|
Prepaid expenses and other current
assets |
|
8,891 |
|
|
|
3,411 |
|
Total current assets |
|
251,360 |
|
|
|
121,848 |
|
|
|
|
|
Investments,
non-current |
|
- |
|
|
|
13,540 |
|
Property and equipment,
net |
|
6,393 |
|
|
|
763 |
|
Manufacturing
know-how |
|
130,315 |
|
|
|
- |
|
Goodwill |
|
60,937 |
|
|
|
- |
|
In-process research
& development |
|
6,171 |
|
|
|
- |
|
Deferred tax assets,
non-current |
|
- |
|
|
|
1,047 |
|
Deferred charge,
non-current |
|
1,400 |
|
|
|
1,695 |
|
Restricted cash,
non-current |
|
- |
|
|
|
2,224 |
|
Other assets |
|
605 |
|
|
|
457 |
|
Total assets |
$ |
457,181 |
|
|
$ |
141,574 |
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY: |
|
|
|
|
|
|
|
|
|
Current
liabilities: |
|
|
|
Accounts payable |
$ |
11,213 |
|
|
$ |
4,143 |
|
Accrued expenses |
|
10,886 |
|
|
|
8,467 |
|
Deferred revenue, current |
|
676 |
|
|
|
2,051 |
|
Collaboration obligation |
|
5,623 |
|
|
|
6,000 |
|
Income tax payable |
|
6,507 |
|
|
|
1,291 |
|
Notes payable, current |
|
39,083 |
|
|
|
8,240 |
|
Other current liabilities |
|
14,139 |
|
|
|
3,618 |
|
Total current liabilities |
|
88,127 |
|
|
|
33,810 |
|
|
|
|
|
Notes payable,
non-current |
|
213,277 |
|
|
|
17,578 |
|
Deferred revenue,
non-current |
|
1,088 |
|
|
|
5,118 |
|
Deferred tax liability
net, non-current |
|
52,497 |
|
|
|
820 |
|
Other liabilities |
|
15,743 |
|
|
|
1,936 |
|
Total liabilities |
|
370,732 |
|
|
|
59,262 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders'
equity: |
|
|
|
Preferred stock, $0.01
par value; 5,000,000 shares authorized at December 31, 2015 and
2014; no shares issued and outstanding at December 31, 2015
and 2014, respectively |
|
- |
|
|
|
- |
|
Class A common stock,
$0.01 par value; 270,000,000 shares authorized at December 31, 2015
and 2014; 45,509,150 and 44,602,988 shares issued and
outstanding at December 31, 2015 and 2014, respectively |
|
455 |
|
|
|
446 |
|
Class B common stock,
$0.01 par value; 75,000,000 shares authorized at December 31, 2015
and 2014; no shares issued and outstanding at December 31, 2015 and
2014, respectively |
|
- |
|
|
|
- |
|
Additional paid-in
capital |
|
99,212 |
|
|
|
83,646 |
|
Accumulated other
comprehensive income |
|
13,412 |
|
|
|
14,265 |
|
Treasury stock, at
cost; 3,009,942 and 524,792 shares at December 31, 2015 and 2014,
respectively |
|
(46,269 |
) |
|
|
(2,313 |
) |
Retained earnings
(Accumulated deficit) |
|
19,639 |
|
|
|
(13,732 |
) |
Total stockholders' equity |
|
86,449 |
|
|
|
82,312 |
|
Total liabilities and
stockholders' equity |
$ |
457,181 |
|
|
$ |
141,574 |
|
Contact:
Sucampo Pharmaceuticals, Inc.
Silvia Taylor
Senior Vice President, Investor Relations and Corporate Affairs
1-240-223-3718
staylor@sucampo.com
Sucampo Pharmaceuticals, Inc. (delisted) (NASDAQ:SCMP)
Historical Stock Chart
From Mar 2024 to Apr 2024
Sucampo Pharmaceuticals, Inc. (delisted) (NASDAQ:SCMP)
Historical Stock Chart
From Apr 2023 to Apr 2024