- Third quarter product prescriptions totaled 102,831,
representing a 78.0% increase over the same quarter last year and a
12.6% increase over the second quarter of 2015.
- Net product sales for the third quarter of 2015 were $38.6
million, representing a 71.7% increase over the same quarter last
year and a 12.5% increase over the second quarter of 2015.
- Operating income for the third quarter of 2015 was $4.3
million, compared to an operating loss of $(0.8) million in the
same quarter last year, which excludes the impact of a $30 million
royalty monetization transaction.
- The Company initiated Phase III clinical trials for SPN-810
during the third quarter of 2015 and a Phase IIb clinical trial for
SPN-812 during the fourth quarter of 2015.
- The Company increased its full year 2015 financial guidance for
net product sales and operating income. The revised ranges are $143
million to $145 million for net product sales and $13 million to
$15 million for operating income.
ROCKVILLE, Md., Nov. 3, 2015 (GLOBE NEWSWIRE) -- 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 the third quarter of 2015 and associated
company developments.
Commercial Update
Third quarter 2015 product prescriptions for Trokendi XR® and
Oxtellar XR® totaled 102,831, a 78.0% increase over the 57,776
product prescriptions for the third quarter of 2014 and an increase
of 12.6% over the 91,324 product prescriptions in the second
quarter of 2015.
|
Prescriptions |
Change in Prescriptions
(%) |
|
Q3 2015 |
Q3 15 vs. Q3 14 |
Q3 15 vs. Q2 15 |
Trokendi XR |
77,331 |
95.7% |
13.8% |
Oxtellar XR |
25,500 |
39.7% |
9.2% |
Total |
102,831 |
78.0% |
12.6% |
Source: Product prescriptions as reported by
Wolters-Kluwer/Symphony
"Our commercial team continues to execute very well in growing
Trokendi XR and Oxtellar XR, as evidenced by the strong growth in
prescriptions and product sales," said Jack Khattar, President and
CEO of Supernus Pharmaceuticals. "We are pleased with our year to
date results, reaching $101 million in total net product
sales."
During October 2015 the Company announced that the U.S. Food and
Drug Administration (FDA) accepted for review the Company's
supplemental new drug application requesting expansion of the
current indication for Trokendi XR to include treatment in adults
for prophylaxis of migraine headache.
Revenues and Gross Margin
Net product sales of Trokendi XR for the third quarter of 2015
were $29.9 million, a 95.4% increase over $15.3 million in the same
period last year and a 13.7% increase over $26.3 million in the
second quarter of 2015. Net product sales of Oxtellar XR in the
third quarter of 2015 were $8.7 million, a 20.8% increase over $7.2
million in the same period last year and an 8.7% increase over $8.0
million in the second quarter of 2015.
Total revenue of $38.6 million in the third quarter of 2015
consisted almost exclusively of net product sales, compared to
total net product sales of $22.5 million in the third quarter of
2014.
Gross margin for the third quarter of 2015 was 94.2%.
Progress of Product Candidates
The Company's product candidates currently in development,
SPN-810 for impulsive aggression in patients who have ADHD and
SPN-812 for ADHD, continue to progress on schedule.
In the third quarter of 2015 the Company filed with the FDA the
special protocol assessment (SPA) on SPN-810 and initiated Phase
III trials. The Company expects to finalize the SPA with the FDA in
the fourth quarter of 2015, prior to first patient dosing.
Regarding SPN-812, a Phase IIb clinical trial was initiated
during the fourth quarter of 2015. In addition, the Company started
a single-ascending dose study and a multiple-ascending dose study
in adult healthy volunteers. Results from these latter
studies are expected in the fourth quarter of 2015.
"Our initiation of Phase III clinical trials for SPN-810
represents another major milestone for Supernus, and positions
SPN-810 as potentially the first product indicated for impulsive
aggression in ADHD for children and adolescents," said Mr. Khattar.
"Our R&D organization continues to make significant progress in
advancing our late-stage pipeline products by initiating multiple
clinical trials in the past few months."
Operating Expenses
Research and development expenses in the third quarter of 2015
were $9.1 million, as compared to $4.7 million in the same quarter
last year. This increase is primarily due to the initiation of
Phase III testing associated with SPN-810, manufacturing and
packaging of clinical trial materials, selection of a CRO and the
screening of clinical trial sites. Research and development
expenses are expected to increase during the fourth quarter of 2015
and throughout 2016 as the Company continues the clinical
advancement of both SPN-810 and SPN-812.
Selling, general and administrative expenses in the third
quarter of 2015 were $22.9 million, as compared to $17.3 million in
the same quarter last year. The higher expense in 2015 reflects
continued marketing programs and promotional materials in support
of Trokendi XR and Oxtellar XR.
Operating Income and Earnings Per Share
The Company reported operating income in the third quarter of
2015 of $4.3 million, as compared to an operating loss of $(0.8)
million in the same period last year excluding the previously
mentioned impact of a $30 million royalty monetization
transaction.
Diluted earnings per share were $0.08 in the third quarter ended
September 30, 2015, compared to $0.39 in the same period last
year.
Weighted average diluted common shares outstanding in the third
quarter of 2015 were approximately 51.6 million, as compared to
approximately 50.8 million in the same period last year.
As of November 3, 2015, approximately $8.5 million of the
Company's six year, $90 million notes, bearing interest at 7.5% per
annum, remained outstanding.
Capital Resources
As of September 30, 2015, the Company had $101.7 million in
cash, cash equivalents, marketable securities, and long term
marketable securities, as compared to $94.2 million at December 31,
2014. Cash flow from operations for the nine months ended
September 30, 2015 was $12.2 million.
Financial Guidance
The Company increased its full year 2015 financial guidance for
both expected net product sales and operating income. The Company
expects that net product sales will range from $143 million to $145
million, with operating income ranging from $13 million to $15
million. This compares to prior guidance of net product sales of
$135 million to $140 million and operating income of $8 million to
$10 million.
The Company expects that expenses will exceed $30 million in
2015, as compared to research and development expenses of $19.6
million in 2014, as the Company progresses the 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 Wednesday, November 4, 2015. 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) 288-1043 |
International dial-in: |
(970) 315-0267 |
Conference ID: |
64872787 |
Conference Call Name: |
Supernus Pharmaceuticals 3Q 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 patients with ADHD in
conjunction with standard ADHD treatment and SPN-812 for 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 and
to add new indications to existing products; 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) |
|
|
|
|
September 30,
2015 |
December 31,
2014 |
|
(unaudited) |
|
|
|
|
Cash, cash equivalents and marketable
securities |
$ 57,702 |
$ 74,336 |
Accounts receivable, net |
23,603 |
17,270 |
Inventories, net |
14,742 |
13,441 |
Prepaid expenses and other current
assets |
6,504 |
3,845 |
Total Current Assets |
102,551 |
108,892 |
|
|
|
Long term marketable securities |
43,967 |
19,816 |
Property and equipment, net |
3,210 |
2,448 |
Intangible assets, net |
16,627 |
5,434 |
Other non-current assets |
415 |
918 |
Total Assets |
$ 166,770 |
$ 137,508 |
|
|
|
Accounts payable |
$ 2,812 |
$ 1,863 |
Accrued sales deduction |
18,820 |
8,461 |
Accrued expenses |
21,353 |
17,026 |
Deferred licensing revenue |
143 |
143 |
Total Current Liabilities |
43,128 |
27,493 |
|
|
|
Deferred licensing revenue, net of current
portion |
1,167 |
1,274 |
Convertible notes, net of discount |
8,068 |
26,947 |
Other non-current liabilities |
3,815 |
3,876 |
Derivative liabilities |
1,156 |
6,564 |
Total Liabilities |
57,334 |
66,154 |
|
|
|
Total Stockholders' Equity |
109,436 |
71,354 |
Total Liabilities & Stockholders'
Equity |
$ 166,770 |
$ 137,508 |
|
Supernus
Pharmaceuticals, Inc. |
Consolidated Statements
of Operations |
(in thousands, except
share and per share data) |
|
|
|
|
|
|
Three Months
ended September 30, |
Nine Months ended
September 30, |
|
2015 |
2014 |
2015 |
2014 |
|
(unaudited) |
(unaudited) |
Revenue |
|
|
|
|
Net product sales |
$ 38,551 |
$ 22,452 |
$ 100,914 |
$ 59,056 |
Revenue from royalty agreement |
— |
30,000 |
— |
30,000 |
Licensing revenue |
35 |
36 |
857 |
2,188 |
|
|
|
|
|
Total revenue |
38,586 |
52,488 |
101,771 |
91,244 |
|
|
|
|
|
Costs and expenses |
|
|
|
|
Cost of product sales |
2,248 |
1,321 |
5,628 |
3,476 |
Research and development |
9,129 |
4,657 |
19,690 |
13,816 |
Selling, general and administrative |
22,900 |
17,343 |
65,637 |
54,452 |
|
|
|
|
|
Total costs and expenses |
34,277 |
23,321 |
90,955 |
71,744 |
|
|
|
|
|
Operating income |
4,309 |
29,167 |
10,816 |
19,500 |
Other income (expense) |
|
|
|
|
Interest income |
169 |
78 |
419 |
265 |
Interest expense |
(292) |
(1,289) |
(1,004) |
(3,774) |
Changes in fair value of derivative
liabilities |
114 |
760 |
66 |
2,115 |
Loss on extinguishment of debt |
(25) |
(860) |
(2,400) |
(2,592) |
Other income |
5 |
2 |
30 |
2 |
|
|
|
|
|
Total other expense |
(29) |
(1,309) |
(2,889) |
(3,984) |
|
|
|
|
|
Earnings before income taxes |
4,280 |
27,858 |
7,927 |
15,516 |
|
|
|
|
|
Income tax expense |
58 |
-- |
782 |
-- |
|
|
|
|
|
Net income |
$ 4,222 |
$ 27,858 |
$ 7,145 |
$ 15,516 |
|
|
|
|
|
Income per common share: |
|
|
|
|
Basic |
$ 0.09 |
$ 0.65 |
$ 0.15 |
$ 0.37 |
Diluted |
$ 0.08 |
$ 0.39 |
$ 0.15 |
$ 0.13 |
|
|
|
|
|
Weighted-average number of common
shares: |
|
|
|
|
Basic |
48,515,071 |
42,900,269 |
47,011,243 |
42,035,025 |
Diluted |
51,590,797 |
50,825,633 |
47,356,146 |
50,378,186 |
CONTACT: 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 Mar 2024 to Apr 2024
Supernus Pharmaceuticals (NASDAQ:SUPN)
Historical Stock Chart
From Apr 2023 to Apr 2024