- Cash flow positive for the fourth quarter, $5.9 million, and
for the full year, $3.2 million.
- Net income for the fourth quarter, $4.4 million, and for the
full year, $19.9 million.
- Total revenue for the fourth quarter, $30.8 million, exceeded
guidance by $4 million, and includes $30.5 million in net product
sales.
- Total revenue for full year 2014 was $122.0 million, including
$89.6 million in net product sales.
- Fourth quarter product prescriptions increased to 70,739,
representing a 22% increase over the third quarter of 2014.
- Met with the FDA in December to review SPN-810. We remain
on-track to initiate Phase III testing in the fourth quarter of
2015.
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 fourth quarter
and full year 2014 and associated company developments.
Business Update
Fourth quarter prescriptions, as reported by Symphony for
Trokendi XR® and Oxtellar XR®, totaled 70,739, increasing by
12,963, or 22%, as compared to third quarter 2014. Trokendi XR
prescriptions for the fourth quarter totaled 50,583, a 28% increase
over the 39,524 prescriptions for the third quarter. Oxtellar XR
prescriptions for the fourth quarter totaled 20,156, a 10% increase
over the 18,252 prescriptions for the third quarter.
Managed care coverage continues to be strong for both products.
Oxtellar XR now has 180.2 million lives covered and Trokendi XR has
174.0 million lives covered. Roughly 89% of Trokendi XR and 90% of
Oxtellar XR national claims are approved by payors.
"During our November earnings call, we reiterated that the
Company would become cash flow positive by the end of the fourth
quarter. Not only was the Company cash flow positive for the month
of December, but it was also significantly cash flow positive for
the entire fourth quarter. In addition, net product revenue of
approximately $30 million for the fourth quarter substantially
exceeded our guidance of $24 million to $26 million. We are
extremely proud of these accomplishments and our employees'
commitment to delivering on our promises," said Jack Khattar,
President and CEO of Supernus Pharmaceuticals.
"We look forward to another strong year in 2015, as we continue
to build on the success of our product launches and growing
prescription base," said Mr. Khattar.
Revenue and Gross Margin
Total revenue for the fourth quarter and full year 2014 was
$30.8 million and $122.0 million, respectively. Full year results
include $89.6 million in net product revenue and $30.0 million in
royalty monetization revenue.
Net product revenue for the fourth quarter 2014 consisted of
$22.9 million for Trokendi XR and $7.6 million for Oxtellar XR and,
for the full year 2014, $64.9 million for Trokendi XR and $24.7
million for Oxtellar XR.
Licensing revenue for the full year 2014 was approximately $2.5
million, primarily consisting of a $2.0 million milestone payment
triggered by the launch of Orenitram® by our partner, United
Therapeutics Corporation.
Gross margin for the fourth quarter and full year 2014 was
approximately 92.5% and 93.6%, respectively.
Operating Expenses
Selling, general and administrative expenses for the fourth
quarter and full year 2014 were $18.0 million and $72.5 million,
respectively, as compared to $15.2 million and $55.6 million in the
respective 2013 periods. The higher expense reflected
expansion of the sales force in early 2014, coupled with increased
promotional and marketing activities to support the expanded sales
force and our products Oxtellar XR and Trokendi XR.
Research and development expenses during the fourth quarter and
full year 2014 were $5.8 million and $19.6 million, respectively,
as compared to $5.4 million and $17.2 million in the respective
2013 periods. This increase is due to preclinical and
clinical trials and manufacturing scale up for both of our lead
product candidates, SPN-810 and SPN-812.
Net Income and Earnings per Share
The Company reported net income for the fourth quarter of $4.4
million, or $0.10 per diluted share, as compared to a net loss of
($22.4) million, or ($0.65) per diluted share, in the fourth
quarter 2013. Non-GAAP net income for the fourth quarter of
2014 was $3.7 million, compared to the non-GAAP net loss for the
fourth quarter of 2013 of ($13.4) million. This year over year
improvement in net income is driven by increased revenue associated
with higher prescription volumes for Oxtellar XR and Trokendi XR,
partially offset by an increase in marketing and research
expenditures.
The Company reported net income for full year 2014 of $19.9
million, or $0.32 per diluted share, as compared to a net loss of
($92.3) million, or ($2.90) per diluted share, for the full year
2013. Non-GAAP net loss for full year 2014 was ($10.3)
million, compared to the non-GAAP net loss for full year 2013 of
($69.4) million.
This improvement is driven primarily by increased revenue
associated with higher prescription volumes from Oxtellar XR and
Trokendi XR, partially offset by expenses associated with the
expansion of our sales force, an increase in marketing
expenditures associated with that sales force expansion, and an
increase in research and development expenses associated with the
development of both of our product candidates, SPN-810 and
SPN-812.
Weighted average diluted common shares outstanding in the fourth
quarter and full year 2014 were approximately 43.2 million and 50.6
million, respectively, as compared to approximately 34.6 million
and 31.8 million during the respective 2013 periods. The diluted
earnings per share calculation assumes that all of our outstanding
convertible debt is converted into shares of common stock. If
this conversion were to occur, the Company would record a loss on
extinguishment of debt, the pro-forma impact of which is
incorporated into the diluted earnings per share calculation.
Summary of Non-GAAP
Adjustments |
(in thousands, except per share
data) |
|
|
Adjustment |
|
|
GAAP |
Revenue from royalty agreement |
Changes in fair value of derivative
liabilities |
Loss on extinguishment of debt |
Non-GAAP |
|
|
|
|
|
|
Three Months ended December 31, 2014 |
|
|
|
|
|
Total Revenue |
$ 30,801 |
$ -- |
$ -- |
$ -- |
$ 30,801 |
Operating income |
4,729 |
— |
— |
— |
4,729 |
Net income (loss) |
4,354 |
— |
(694) |
— |
3,660 |
|
|
|
|
|
|
Income (loss) per common
share-basic |
0.10 |
— |
(0.01) |
— |
0.09 |
Income (loss) per common
share-diluted |
0.10 |
— |
(0.02) |
— |
0.08 |
|
|
|
|
|
|
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) |
(2,809) |
2,592 |
(10,346) |
|
|
|
|
|
|
Income (loss) per common
share-basic |
0.47 |
— |
(0.71) |
— |
(0.24) |
Income (loss) per common
share-diluted |
0.32 |
— |
(0.56) |
— |
(0.24) |
|
|
|
|
|
|
Three Months ended December 31, 2013 |
|
|
|
|
|
Total Revenue |
$ 10,334 |
$ -- |
$ -- |
$ -- |
$ 10,334 |
Operating income |
(11,357) |
— |
— |
— |
(11,357) |
Net income (loss) |
(22,406) |
— |
662 |
8,388 |
(13,356) |
|
|
|
|
|
|
Income (loss) per common
share-basic |
(0.65) |
— |
0.26 |
— |
(0.39) |
Income (loss) per common
share-diluted |
(0.65) |
— |
0.26 |
— |
(0.39) |
|
|
|
|
|
|
Year ended December 31, 2013 |
|
|
|
|
|
Total Revenue |
$ 12,019 |
$ -- |
$ -- |
$ -- |
$ 12,019 |
Operating income |
(61,920) |
— |
— |
— |
(61,920) |
Net income (loss) |
(92,273) |
— |
13,354 |
9,550 |
(69,369) |
|
|
|
|
|
|
Income (loss) per common
share-basic |
(2.90) |
— |
0.72 |
— |
(2.18) |
Income (loss) per common
share-diluted |
(2.90) |
— |
0.72 |
— |
(2.18) |
As of December 31, 2014, approximately $36.1 million, or 40%, of
the Company's six year, $90 million convertible secured notes,
bearing interest at 7.5% per annum, remain outstanding. In
2015, an additional $5.0 million of the remaining notes have been
converted into shares of common stock, reducing the balance of the
notes to approximately $31.1 million.
Capital Resources
As of December 31, 2014, the Company had $94.2 million in cash,
cash equivalents, marketable securities, and long term marketable
securities, as compared to $88.3 million at September 30, 2014, and
$90.9 million at December 31, 2013. This increase from
September 30, 2014, was due to positive cash flow of $5.9 million
during the fourth quarter 2014.
Cash flow for full year 2014 was approximately $3.2 million,
including $30.0 million in revenue from royalty agreement, which
was offset partially by losses from on-going operations.
Financial Guidance
For full year 2015, the Company estimates that total revenue
will grow by approximately 50%, ranging from $130 million to $140
million, with operating income ranging from $6 million to $10
million.
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.
Concerning SPN-810, the Company held an end of Phase II meeting
with the FDA in December 2014 to discuss the current development of
the product and protocols for future studies. Based on
this meeting, we continue to plan to initiate Phase III clinical
testing during the fourth quarter of 2015. We are in the
process of finalizing the specific outcomes and assessment scale to
be used in those trials. We are targeting to meet with the FDA
during the second quarter to review the scale and our request for a
special protocol assessment.
Concerning SPN-812, the Company expects to start a Phase IIb
trial during the fourth quarter of 2015. As previously
announced the Company has selected an extended release formulation
that will be the basis for the product to be used in future trials.
The Company continues to progress development activities on the
active drug substance, conducting further pharmacokinetic studies
and preclinical activities that are required for the completion of
the new drug application.
Investor Day
We are pleased to announce our first ever Investor Day to be
held at the New York Marriott East Side on June 17, 2015. We
plan to provide an overview of the Company including a detailed
discussion on our clinical programs and our assessment of the
market opportunity.
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, March 11, 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: |
86364108 |
Conference Call Name: |
Supernus Pharmaceuticals 4Q and Full Year
2014 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, or CNS, 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.
These product candidates include 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 maintain 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.
Condensed Consolidated
Balance Sheets |
(in
thousands) |
|
|
|
|
December 31,
2014 |
December 31,
2013 |
|
(unaudited) |
|
|
|
|
Cash, cash equivalents and marketable
securities |
$ 74,336 |
$ 82,191 |
Accounts receivable, net |
17,270 |
5,054 |
Inventories |
13,441 |
7,152 |
Other current assets |
3,845 |
2,764 |
Total Current Assets |
108,892 |
97,161 |
|
|
|
Long term marketable securities |
19,816 |
8,756 |
Property and equipment, net |
2,448 |
2,554 |
Other long-term assets |
6,352 |
2,524 |
Total Assets |
$ 137,508 |
$ 110,995 |
|
|
|
Accounts payable |
$ 1,863 |
$ 3,142 |
Accrued expenses |
25,487 |
15,172 |
Deferred product revenue, net |
— |
7,882 |
Deferred licensing revenue |
143 |
204 |
Total Current Liabilities |
27,493 |
26,400 |
|
|
|
Deferred licensing revenue, net of current
portion |
1,274 |
1,417 |
Convertible notes, net of discount |
26,947 |
34,393 |
Other non-current liabilities |
3,876 |
2,677 |
Derivative liabilities |
6,564 |
12,644 |
Total Liabilities |
66,154 |
77,531 |
|
|
|
Total Stockholders' Equity |
71,354 |
33,464 |
Total Liabilities & Stockholders
Equity |
$ 137,508 |
$ 110,995 |
|
Consolidated Statements
of Operations |
(in thousands, except
share and per share data) |
|
|
|
|
|
|
Three Months
ended December 31, |
Year ended
December 31, |
|
2014 |
2013 |
2014 |
2013 |
|
(unaudited) |
(unaudited) |
|
|
|
|
|
|
Revenue |
|
|
|
|
Net product sales |
$ 30,515 |
$ 10,268 |
$ 89,571 |
$ 11,552 |
Revenue from royalty
agreement |
— |
— |
30,000 |
— |
Licensing revenue |
286 |
66 |
2,474 |
467 |
|
|
|
|
|
Total revenue |
30,801 |
10,334 |
122,045 |
12,019 |
|
|
|
|
|
Costs and expenses |
|
|
|
|
Cost of product sales |
2,282 |
1,066 |
5,758 |
1,104 |
Research and development |
5,772 |
5,402 |
19,586 |
17,245 |
Selling, general and
administrative |
18,018 |
15,223 |
72,471 |
55,590 |
|
|
|
|
|
Total costs and expenses |
26,072 |
21,691 |
97,815 |
73,939 |
|
|
|
|
|
Operating income (loss) |
4,729 |
(11,357) |
24,230 |
(61,920) |
Other income (expense) |
|
|
|
|
Interest income and other
income |
120 |
108 |
387 |
400 |
Interest expense |
(1,189) |
(2,107) |
(4,963) |
(7,849) |
Changes in fair value of
derivative liabilities |
694 |
(662) |
2,809 |
(13,354) |
Loss on extinguishment of
debt |
— |
(8,388) |
(2,592) |
(9,550) |
|
|
|
|
|
Total other expense |
(375) |
(11,049) |
(4,359) |
(30,353) |
|
|
|
|
|
Net income (loss) |
$ 4,354 |
$ (22,406) |
$ 19,871 |
$ (92,273) |
|
|
|
|
|
Income (loss) per common share: |
|
|
|
|
Basic |
$ 0.10 |
$ (0.65) |
$ 0.47 |
$ (2.90) |
Diluted |
$ 0.10 |
$ (0.65) |
$ 0.32 |
$ (2.90) |
|
|
|
|
|
Weighted-average number of common
shares: |
|
|
|
|
Basic |
42,931,146 |
34,647,803 |
42,260,896 |
31,848,299 |
Diluted |
43,201,227 |
34,647,803 |
50,583,511 |
31,848,299 |
CONTACT: Jack A. Khattar, President and CEO
Gregory S. Patrick, Vice President and CFO
Supernus Pharmaceuticals, Inc.
301-838-2591
or
INVESTOR CONTACT:
Peter Vozzo
Westwicke Partners
Office: (443) 213-0505
Mobile: (443) 377-4767
Email: peter.vozzo@westwicke.com
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