Supernus Pharmaceuticals, Inc. (NASDAQ:SUPN), a specialty
pharmaceutical company focused on developing and commercializing
products for the treatment of central nervous system (CNS)
diseases, today reported financial results for fourth quarter and
full year 2015 and associated company developments.
Commercial Update
Fourth quarter 2015 product prescriptions for Trokendi XR® and
Oxtellar XR®, as reported by IMS, totaled 111,627, a 61.3% increase
over the fourth quarter of 2014 and an increase of 10.8% over the
third quarter of 2015. Full year 2015 product prescriptions for
Trokendi XR® and Oxtellar XR® totaled 378,173, a 90.6% increase
over full year 2014.
|
|
Prescriptions |
Increase in
Prescriptions (%) |
|
|
Q4 2015 |
Q3 2015 |
Q4 2014 |
Q4 15 vs. Q3 15 |
|
Q4 15 vs. Q4
14 |
|
|
|
|
|
|
|
|
Trokendi XR |
83,899 |
75,104 |
49,220 |
11.7 |
% |
|
|
|
|
70.5 |
% |
Oxtellar XR |
27,728 |
25,666 |
19,988 |
8.0 |
% |
|
|
|
|
38.7 |
% |
|
Total |
111,627 |
100,770 |
69,208 |
10.8 |
% |
|
|
|
|
61.3 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Prescriptions |
Increase in Prescriptions (%) |
|
|
|
|
FY 2015 |
FY 2014 |
FY 2015 vs.
FY 2014 |
|
|
|
|
|
|
|
|
|
|
|
Trokendi XR |
279,782 |
135,238 |
|
|
106.9 |
% |
|
|
|
Oxtellar XR |
98,391 |
63,153 |
|
|
55.8 |
% |
|
|
|
|
Total |
378,173 |
198,391 |
|
|
90.6 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Source: Product prescriptions as reported by IMS
“2015 was a year of significant achievements, where we delivered
on our commercial strategy for Trokendi XR and Oxtellar XR, and
progressed our pipeline into late-stage clinical testing,” said
Jack Khattar, President and CEO of Supernus Pharmaceuticals. “We
met our upwardly revised product sales guidance, with total net
product sales reaching $143.5 million in 2015. Based on the
strength of our base business, we were able to achieve, for the
first time, profitability from on-going operations each quarter and
for the full year. We also filed a supplemental new drug
application during the year requesting a label expansion for
Trokendi XR to include treatment in adults for migraine headache,
which was accepted for review by the FDA. Finally, we continue to
defend vigorously our novel products and build upon our strong
intellectual property position, as evidenced by the recent
favorable Federal court ruling on Oxtellar XR and the settlement
agreement we entered into with Par Pharmaceuticals in 2015 for
Trokendi XR.”
Progress of Product Pipeline
The Company remains on schedule with its two Phase III trials
for SPN-810 and the Phase IIb trial for SPN-812. During the first
quarter, we are actively recruiting and screening patients for all
trials. Phase III data for SPN-810 is expected to be
available by mid 2017, and data from the SPN-812 Phase IIb trial is
expected to be available by early 2017.
During the fourth quarter of 2015, the Company finalized the SPA
for SPN-810 with the FDA, conducted an investigator meeting with
approximately 50 participating centers covering both Phase III
trials, and began site initiation visits.
Regarding SPN-812, during the fourth quarter of 2015 final
results were received from a single-ascending dose (SAD) study and
a multiple-ascending dose (MAD) study in adult healthy volunteers.
These data showed an overwhelmingly favorable adverse event profile
for our extended-release formulation at doses that are several
multiples of the effective doses used in the immediate release
formulation in the Phase IIa study.
“We are very excited about the emerging clinical profile of
SPN-812. Data from our SAD and MAD studies reinforce our belief
that SPN-812 has the potential for being dosed at levels high
enough to compare favorably with stimulant medications for
efficacy, while still showing a favorable tolerability and safety
profile,” said Jack Khattar, President and CEO of Supernus
Pharmaceuticals.
Revenues and Gross Margin
Net product sales for the fourth quarter of 2015 were $42.6
million, a 39.6% increase over $30.5 million in the same period
last year and a 10.5% increase over $38.6 million in the third
quarter of 2015. Net product sales for full year 2015 were $143.5
million, a 60.2% increase over $89.6 million in 2014.
|
|
Net Product Sales ($mil.) |
|
Increase in Net Product Sales
(%) |
|
|
Q4 2015 |
Q3 2015 |
Q4 2014 |
|
Q4 15 vs. Q3 15 |
Q4 15 vs. Q4 14 |
|
|
|
|
|
|
|
|
|
|
Trokendi XR |
$ |
33.3 |
|
$ |
29.9 |
|
$ |
22.9 |
|
|
|
11.4 |
% |
|
|
45.5 |
% |
|
Oxtellar XR |
$ |
9.3 |
|
$ |
8.7 |
|
$ |
7.6 |
|
|
|
6.9 |
% |
|
|
22.4 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
Total |
$ |
42.6 |
|
$ |
38.6 |
|
$ |
30.5 |
|
|
|
10.5 |
% |
|
|
39.6 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Product Sales ($mil.) |
|
Increase in Net Product Sales
(%) |
|
|
|
FY 2015 |
FY 2014 |
|
FY 2015 vs. FY 2014 |
|
|
|
|
|
|
|
|
|
|
|
Trokendi XR |
$ |
110.3 |
|
$ |
64.9 |
|
|
|
|
|
70.1 |
% |
|
Oxtellar XR |
$ |
33.2 |
|
$ |
24.7 |
|
|
|
|
|
34.4 |
% |
|
|
|
|
|
|
|
|
|
|
Total |
$ |
143.5 |
|
$ |
89.6 |
|
|
|
|
|
60.2 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenue for full year 2015 was $144.4 million, compared to
$122.0 million for full year 2014. Total revenue for 2015 consisted
almost exclusively of net product sales while total revenue for
2014 included the impact of a onetime $30.0 million royalty
monetization.
Gross margin was 93.4% and 94.1% for the fourth quarter and full
year 2015, respectively, compared to 92.5% and 93.6% for the
comparable periods in 2014.
Operating Expenses
Research and development expenses in the fourth quarter of 2015
were $9.4 million, as compared to $5.8 million in the same quarter
last year. This increase is primarily due to the initiation of
Phase III testing associated with SPN-810 during the third quarter
of 2015 and the initiation of Phase IIb testing of SPN-812 during
the fourth quarter of 2015. Research and development expenses for
full year 2015 were $29.1 million, as compared to $19.6 million in
2014. This increase is primarily due to increased clinical
development activities associated with the initiation of our
late-stage studies for SPN-810 and SPN-812, including the
manufacture of clinical supplies and the screening of clinical
trial sites.
Selling, general and administrative expenses in the fourth
quarter of 2015 were $23.6 million, as compared to $18.0 million in
the same quarter last year. Selling, general and administrative
expenses were $89.2 million in 2015, compared to $72.5 million in
2014. The higher expenses in the fourth quarter and the full year
2015, compared to the year earlier periods, reflect increased
promotional and marketing activities to support the growth of
Trokendi XR and Oxtellar XR, as well as work done in anticipation
of launching the migraine headache indication for Trokendi XR in
2016.
Operating Income and Earnings Per Share
For the first time, the Company was profitable from ongoing
operations for the full year as well as in each quarter of the
year. Operating income in the fourth quarter of 2015 was $6.8
million, an increase of 44.8% over operating income of $4.7 million
in the same period last year. Full year 2015 operating income was
$17.7 million. Excluding the impact of a $30.0 million
royalty monetization payment, operating loss for 2014 was $5.8
million. The substantial improvement in operating income for
2015 reflects the strength and growth of the Company’s base
business.
Diluted earnings per share were $0.14 in the fourth quarter
ended December 31, 2015, compared to $0.10 in the same period last
year. Diluted earnings per share were $0.28 in 2015, compared to a
loss of $0.24 in 2014, excluding the impact of a $30.0 million
royalty monetization.
Weighted-average diluted common shares outstanding were
approximately 49.6 million and 51.2 million in the fourth quarter
and full year of 2015, respectively, as compared to approximately
43.2 million and 50.6 million in the respective periods the prior
year.
Capital Resources
As of December 31, 2015, the Company had $117.2 million in cash,
cash equivalents, marketable securities, and long term marketable
securities, as compared to $94.2 million at December 31,
2014.
Financial Guidance
For full year 2016, the Company estimates that net product sales
will range from $200 million to $210 million, with operating income
ranging from $28 million to $35 million.
The Company expects that research and development expenses in
2016 will range from $55 million to $65 million as the Company
progresses late-stage development of SPN-810 and SPN-812.
Conference Call Details
The Company will hold a conference call hosted by Jack Khattar,
President and Chief Executive Officer, and Greg Patrick, Vice
President and Chief Financial Officer, to discuss these results at
9:00 a.m. ET, on Thursday, March 3, 2016. An accompanying webcast
also will be provided.
Please refer to the information below for conference call
dial-in information and webcast registration. Callers should dial
in approximately 10 minutes prior to the start of the call.
Conference
dial-in:
(877) 288-1043International
dial-in:
(970) 315-0267Conference ID:
47017444Conference Call
Name:
Supernus Pharmaceuticals 4Q and Full Year 2015 Earnings Conference
Call
Following the live call, a replay will be available on the
Company's website, www.supernus.com, under ‘Investors’.
About Supernus Pharmaceuticals, Inc.
Supernus Pharmaceuticals, Inc. is a specialty pharmaceutical
company focused on developing and commercializing products for the
treatment of central nervous system diseases. The Company has two
marketed products for epilepsy, Oxtellar XR® (extended-release
oxcarbazepine) and Trokendi XR® (extended-release topiramate). The
Company is also developing several product candidates to address
large market opportunities in psychiatry, including SPN-810 for the
treatment of impulsive aggression in ADHD patients. SPN-812 is
being developed for treatment of ADHD.
Forward-Looking Statements:
This press release includes forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. These statements do not convey historical information, but
relate to predicted or potential future events that are based upon
management's current expectations. These statements are subject to
risks and uncertainties that could cause actual results to differ
materially from those expressed or implied by such statements. In
addition to the factors mentioned in this press release, such risks
and uncertainties include, but are not limited to, the Company’s
ability to sustain and increase its profitability; the Company’s
ability to raise sufficient capital to fully implement its
corporate strategy; the implementation of the Company’s corporate
strategy; the Company’s future financial performance and projected
expenditures; the Company’s ability to increase the number of
prescriptions written for each of its products; the Company’s
ability to increase its net revenue; the Company’s ability to enter
into future collaborations with pharmaceutical companies and
academic institutions or to obtain funding from government
agencies; the Company’s product research and development
activities, including the timing and progress of the Company’s
clinical trials, and projected expenditures; the Company’s ability
to receive, and the timing of any receipt of, regulatory approvals
to develop and commercialize the Company’s product candidates; the
Company’s ability to protect its intellectual property and operate
its business without infringing upon the intellectual property
rights of others; the Company’s expectations regarding federal,
state and foreign regulatory requirements; the therapeutic
benefits, effectiveness and safety of the Company’s product
candidates; the accuracy of the Company’s estimates of the size and
characteristics of the markets that may be addressed by its product
candidates; the Company’s ability to increase its manufacturing
capabilities for its products and product candidates; the Company’s
projected markets and growth in markets; the Company’s product
formulations and patient needs and potential funding sources; the
Company’s staffing needs; and other risk factors set forth from
time to time in the Company’s SEC filings made pursuant to Section
13 or 15(d) of the Securities Exchange Act of 1934, as amended. The
Company undertakes no obligation to update the information in this
press release to reflect events or circumstances after the date
hereof or to reflect the occurrence of anticipated or unanticipated
events.
Supernus Pharmaceuticals, Inc. |
Condensed Consolidated Balance
Sheets |
(in thousands) |
|
|
|
|
|
|
|
|
|
|
December 31, 2015 |
|
|
December 31, 2014 |
|
|
|
(unaudited) |
|
|
|
|
|
|
|
|
|
|
Cash, cash equivalents
and marketable securities |
|
$ |
62,190 |
|
$ |
74,336 |
Accounts receivable,
net |
|
|
25,908 |
|
|
17,270 |
Inventories, net |
|
|
12,587 |
|
|
13,441 |
Prepaid expenses and
other current assets |
|
|
5,292 |
|
|
3,845 |
Total Current
Assets |
|
|
105,977 |
|
|
108,892 |
|
|
|
|
|
|
|
Long
term marketable securities |
|
|
55,009 |
|
|
19,816 |
Property and equipment,
net |
|
|
3,874 |
|
|
2,448 |
Deferred legal
fees |
|
|
22,503 |
|
|
5,209 |
Intangible assets,
net |
|
|
976 |
|
|
225 |
Other non-current
assets |
|
|
391 |
|
|
918 |
Total Assets |
|
$ |
188,730 |
|
$ |
137,508 |
|
|
|
|
|
|
|
Accounts payable |
|
$ |
4,314 |
|
$ |
1,863 |
Accrued sales
deduction |
|
|
26,794 |
|
|
8,461 |
Accrued expenses |
|
|
24,813 |
|
|
17,026 |
Deferred licensing
revenue |
|
|
176 |
|
|
143 |
Total Current
Liabilities |
|
|
56,097 |
|
|
27,493 |
|
|
|
|
|
|
|
Deferred licensing
revenue, net of current portion |
|
|
1,390 |
|
|
1,274 |
Convertible notes, net
of discount |
|
|
7,189 |
|
|
26,947 |
Other non-current
liabilities |
|
|
4,325 |
|
|
3,876 |
Derivative
liabilities |
|
|
854 |
|
|
6,564 |
Total Liabilities |
|
|
69,855 |
|
|
66,154 |
|
|
|
|
|
|
|
Total Stockholders'
Equity |
|
|
118,875 |
|
|
71,354 |
Total
Liabilities & Stockholders' Equity |
$ |
188,730 |
|
$ |
137,508 |
Supernus Pharmaceuticals, Inc. |
Consolidated Statements of
Operations |
(in thousands, except share and per share
data) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months ended December 31, |
|
Year ended December 31, |
|
2015 |
|
2014 |
|
2015 |
|
2014 |
|
|
|
|
|
|
|
|
|
|
|
|
|
(unaudited) |
|
(unaudited) |
|
|
|
Revenue |
|
|
|
|
|
|
|
|
|
|
|
Net product sales |
$ |
|
42,611 |
|
|
$ |
|
30,515 |
|
|
$ |
|
143,526 |
|
|
$ |
|
89,571 |
|
Revenue from royalty agreement |
|
|
— |
|
|
|
|
— |
|
|
|
|
— |
|
|
|
|
30,000 |
|
Licensing revenue |
|
|
44 |
|
|
|
|
286 |
|
|
|
|
901 |
|
|
|
|
2,474 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
revenue |
|
|
42,655 |
|
|
|
|
30,801 |
|
|
|
|
144,427 |
|
|
|
|
122,045 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Costs and expenses |
|
|
|
|
|
|
|
|
|
|
|
Cost of product sales |
|
|
2,794 |
|
|
|
|
2,282 |
|
|
|
|
8,423 |
|
|
|
|
5,758 |
|
Research and development |
|
|
9,446 |
|
|
|
|
5,772 |
|
|
|
|
29,135 |
|
|
|
|
19,586 |
|
Selling, general and
administrative |
|
|
23,566 |
|
|
|
|
18,018 |
|
|
|
|
89,204 |
|
|
|
|
72,471 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total costs and
expenses |
|
|
35,806 |
|
|
|
|
26,072 |
|
|
|
|
126,762 |
|
|
|
|
97,815 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating income |
|
|
6,849 |
|
|
|
|
4,729 |
|
|
|
|
17,665 |
|
|
|
|
24,230 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income
(expense) |
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
225 |
|
|
|
|
83 |
|
|
|
|
643 |
|
|
|
|
348 |
|
Interest expense |
|
|
(225 |
) |
|
|
|
(1,189 |
) |
|
|
|
(1,229 |
) |
|
|
|
(4,963 |
) |
Changes in fair value of derivative
liabilities |
|
|
127 |
|
|
|
|
694 |
|
|
|
|
193 |
|
|
|
|
2,809 |
|
Loss on extinguishment of debt |
|
|
62 |
|
|
|
|
— |
|
|
|
|
(2,338 |
) |
|
|
|
(2,592 |
) |
Other income |
|
|
8 |
|
|
|
|
37 |
|
|
|
|
38 |
|
|
|
|
39 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total other
expense |
|
|
197 |
|
|
|
|
(375 |
) |
|
|
|
(2,693 |
) |
|
|
|
(4,359 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Earnings before income
taxes |
|
|
7,046 |
|
|
|
|
4,354 |
|
|
|
|
14,972 |
|
|
|
|
19,871 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Income
tax expense |
|
|
174 |
|
|
|
|
— |
|
|
|
|
956 |
|
|
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
$ |
|
6,872 |
|
|
$ |
|
4,354 |
|
|
$ |
|
14,016 |
|
|
$ |
|
19,871 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Income per common
share: |
|
|
|
|
|
|
|
|
|
|
|
Basic |
$ |
|
0.14 |
|
|
$ |
|
0.10 |
|
|
$ |
|
0.30 |
|
|
$ |
|
0.47 |
|
Diluted |
$ |
|
0.14 |
|
|
$ |
|
0.10 |
|
|
$ |
|
0.28 |
|
|
$ |
|
0.32 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average number
of common shares: |
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
|
48,891,847 |
|
|
|
|
42,931,146 |
|
|
|
|
47,485,258 |
|
|
|
|
42,260,896 |
|
Diluted |
|
|
49,598,030 |
|
|
|
|
43,201,227 |
|
|
|
|
51,160,380 |
|
|
|
|
50,583,511 |
|
Summary of Non-GAAP Adjustments |
(in thousands, except per share data) |
|
|
|
Adjustment |
|
|
|
|
Revenue from |
|
|
|
GAAP |
Royalty Agreement |
Non-GAAP |
|
|
|
|
|
Year ended December 31, 2014 |
|
|
|
|
Total Revenue |
$ |
122,045 |
|
$ |
(30,000 |
) |
$ |
92,045 |
|
|
Operating income |
|
24,230 |
|
|
(30,000 |
) |
|
(5,770 |
) |
|
Net income (loss) |
|
19,871 |
|
|
(30,000 |
) |
|
(10,129 |
) |
|
|
|
|
|
|
Income (loss) per common
share-basic |
|
0.47 |
|
|
— |
|
|
(0.24 |
) |
|
Income (loss) per common
share-diluted |
|
0.32 |
|
|
— |
|
|
(0.24 |
) |
|
|
|
|
|
|
Weighted-average number of common
shares: |
|
|
|
|
|
|
Basic |
|
42,260,896 |
|
|
|
42,260,896 |
|
|
Diluted |
|
50,583,511 |
|
|
|
42,260,896 |
|
CONTACTS:
Jack A. Khattar, President and CEO
Gregory S. Patrick, Vice President and CFO
Supernus Pharmaceuticals, Inc.
Tel: (301) 838-2591
or
INVESTOR CONTACT:
Peter Vozzo
Westwicke Partners
Office: (443) 213-0505
Mobile: (443) 377-4767
Email: peter.vozzo@westwicke.com
Supernus Pharmaceuticals (NASDAQ:SUPN)
Historical Stock Chart
From Aug 2024 to Sep 2024
Supernus Pharmaceuticals (NASDAQ:SUPN)
Historical Stock Chart
From Sep 2023 to Sep 2024