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 second quarter 2016
and associated company developments.
Commercial Update
Second quarter 2016 product prescriptions for
Trokendi XR® and Oxtellar XR®, as reported by IMS, totaled 123,758,
a 38.9% increase over the second quarter of 2015.
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Prescriptions |
|
|
|
|
Q2 2016 |
|
Q1 2015 |
|
Change % |
|
|
|
|
|
|
|
Trokendi XR |
|
93,094 |
|
65,552 |
|
|
42.0 |
% |
Oxtellar XR |
|
30,664 |
|
23,534 |
|
|
30.3 |
% |
|
|
|
|
|
|
|
Total |
|
123,758 |
|
89,086 |
|
|
38.9 |
% |
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|
Source: IMS |
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Total revenue for the second quarter of 2016 was
$50.4 million, a 43.8% increase over $35.1 million in the same
period last year. Total revenue for both periods consisted almost
exclusively of net product sales.
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Net Product Sales ($mil.) |
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|
|
Q2 2016 |
|
Q2 2015 |
|
Change % |
|
|
|
|
|
|
|
Trokendi XR |
|
$ |
37.6 |
|
|
$ |
26.3 |
|
|
|
43.3 |
% |
Oxtellar XR |
|
$ |
12.7 |
|
|
$ |
8.0 |
|
|
|
58.7 |
% |
|
|
|
|
|
|
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Total |
|
$ |
50.3 |
|
|
$ |
34.3 |
|
|
|
46.9 |
% |
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|
“We are pleased with the growth in prescriptions
and net product sales in the second quarter and through the first
half of 2016. For the first six months of 2016, net product sales
increased approximately 50%, as compared to the same period last
year,” said Jack Khattar, President and CEO of Supernus
Pharmaceuticals. “The solid growth in prescriptions behind our
products three years post launch reinforces our belief that the
combined annual peak sales for Oxtellar XR and Trokendi XR can
exceed $500 million.”
In June 2016 the Company submitted the revised
label for Trokendi XR requesting approval to expand the label to
include treatment of migraine in adults. As previously announced,
this resubmission was requested by the Food and Drug Administration
(FDA) to review the proposed label in a different format. The FDA
has set a target date in the third quarter of 2016 to complete its
review. We continue to prepare and will be ready to launch the
migraine indication soon after receiving full FDA approval.
Progress of Product Pipeline
Enrollment continues for both Phase III trials for
SPN-810, which is currently in development for Impulsive Aggression
in patients aged 6 to 12 years who have ADHD. The pace of
enrollment is slower than anticipated due to challenges such as
those experienced by caregivers in recording patient information on
the new electronic diary, and lack of compliance during the
screening period regarding ‘washing out’ of current medications. As
a consequence, we have instituted a number of measures to improve
patient enrollment and retention. These include lengthening the
screening period to provide increased education for site
coordinators and caregivers on the electronic diary and to make it
easier for caregivers and patients to comply with the trial
protocol. Although the pace of recruitment has picked up recently
for both Phase III trials, it is likely that enrollment will
continue into 2017. The Company continues to expect to launch
SPN-810 in 2019. During the third quarter of 2016, patients began
enrolling into the open-label extension portion of the Phase III
study.
Regarding SPN-812, currently in development for
patients aged 6 to 12 years with ADHD, the Phase IIb trial is now
fully recruited. The final patient visit was completed during the
third quarter of 2016. Eligible patients are now entering the open
label extension portion of the study. The Company continues to
expect data from the SPN-812 Phase IIb trial to be available by
early 2017.
“With the SPN-812 Phase IIb trial fully enrolled,
we have reached another important clinical milestone as we continue
to advance SPN-812 into late-stage development,” said Jack Khattar.
“Regarding SPN-810, we are encouraged by the recent progress in
improving recruitment and retention, and we remain focused on the
successful execution of the trials.”
Mr. Khattar added, “We believe the 84% rate of
enrollment into the open-label extension of the Phase IIb study for
SPN-812 reflects a high level of satisfaction from physicians and
patients.”
Operating Expenses
Research and development expenses in the second
quarter of 2016 were $11.1 million, as compared to $6.9 million in
the same quarter last year. This increase is primarily due to the
ongoing Phase III testing of SPN-810 and Phase IIb testing of
SPN-812, as well as the open-label extension studies associated
with both SPN-810 and SPN-812.
Selling, general and administrative expenses in the
second quarter of 2016 were $26.1 million, as compared to $23.3
million in the same quarter last year. The increase is primarily
due to the efforts in preparing for the launch of the migraine
indication for Trokendi XR.
Operating Income and Earnings Per
Share
Operating income in the second quarter of 2016 was
$10.4 million, as compared to $3.1 million in the same period last
year. This improvement in operating income is primarily due to
increased net product sales.
Diluted earnings per share were $0.18 in the second
quarter of 2016, as compared to $0.03 in the same period last
year.
Weighted-average diluted common shares outstanding
were approximately 51.7 million in the second quarter of 2016, as
compared to approximately 52.3 million in the same period last
year.
Capital Resources
As of June 30, 2016, the Company had $128.0 million
in cash, cash equivalents, marketable securities, and long term
marketable securities, as compared to $117.2 million at December
31, 2015. As of June 30, 2016, approximately $6.6 million of
the Company’s six year, $90 million notes, bearing interest at 7.5%
per annum, remain outstanding.
Financial Guidance
For full year 2016, the Company is reiterating
guidance for net product sales and adjusting guidance for R&D
expenses and operating income as set forth below:
- Net product sales will remain in the range of $200 million to
$210 million.
- R&D expenses in the range of $50 million to $55 million,
compared to the previously expected range of $55 million to $65
million.
- Operating income in the range of $32 million to $37 million,
compared to the previously expected range of $28 million to $35
million.
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, August 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.
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Conference dial-in: |
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(877) 288-1043 |
International dial-in: |
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(970) 315-0267 |
Conference ID: |
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50720151 |
Conference Call Name: |
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Supernus Pharmaceuticals 2Q 2016 Earnings
Conference Call |
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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 and SPN-812 for the 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) |
|
|
|
|
|
|
|
|
|
|
June 30, 2016 |
|
|
December 31, 2015 |
|
|
|
(unaudited) |
|
|
|
|
|
|
|
|
|
|
Cash, cash equivalents
and marketable securities |
|
$ |
60,214 |
|
$ |
62,190 |
Accounts receivable,
net |
|
|
34,281 |
|
|
25,908 |
Inventories, net |
|
|
16,373 |
|
|
12,587 |
Prepaid expenses and
other current assets |
|
|
3,272 |
|
|
5,261 |
Total Current
Assets |
|
|
114,140 |
|
|
105,946 |
|
|
|
|
|
|
|
Long
term marketable securities |
|
|
67,809 |
|
|
55,009 |
Property and equipment,
net |
|
|
4,193 |
|
|
3,874 |
Deferred legal
fees |
|
|
16,901 |
|
|
22,503 |
Intangible assets,
net |
|
|
15,270 |
|
|
976 |
Other non-current
assets |
|
|
320 |
|
|
318 |
Total Assets |
|
$ |
218,633 |
|
$ |
188,626 |
|
|
|
|
|
|
|
Accounts payable |
|
$ |
2,243 |
|
$ |
4,314 |
Accrued sales
deductions |
|
|
35,019 |
|
|
26,794 |
Accrued expenses |
|
|
28,102 |
|
|
24,813 |
Deferred licensing
revenue |
|
|
208 |
|
|
176 |
Total Current
Liabilities |
|
|
65,572 |
|
|
56,097 |
|
|
|
|
|
|
|
Deferred licensing
revenue, net of current portion |
|
|
1,606 |
|
|
1,390 |
Convertible notes, net
of discount |
|
|
5,699 |
|
|
7,085 |
Other non-current
liabilities |
|
|
4,322 |
|
|
4,325 |
Derivative
liabilities |
|
|
412 |
|
|
854 |
Total Liabilities |
|
|
77,611 |
|
|
69,751 |
|
|
|
|
|
|
|
Total Stockholders'
Equity |
|
|
141,022 |
|
|
118,875 |
Total Liabilities &
Stockholders' Equity |
|
$ |
218,633 |
|
$ |
188,626 |
|
|
|
|
|
|
|
Supernus Pharmaceuticals, Inc. |
Consolidated Statements of
Operations |
(in thousands, except share and per share
data) |
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Three Months ended June 30, |
|
Six Months ended June 30, |
|
2016 |
|
2015 |
|
2016 |
|
2015 |
|
(unaudited) |
|
(unaudited) |
Revenue |
|
|
|
|
|
|
|
|
|
|
|
Net product sales |
$ |
|
50,335 |
|
|
$ |
|
34,266 |
|
|
$ |
|
93,360 |
|
|
$ |
|
62,363 |
|
Licensing revenue |
|
|
86 |
|
|
|
|
786 |
|
|
|
|
135 |
|
|
|
|
822 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
revenue |
|
|
50,421 |
|
|
|
|
35,052 |
|
|
|
|
93,495 |
|
|
|
|
63,185 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Costs and expenses |
|
|
|
|
|
|
|
|
|
|
|
Cost of product sales |
|
|
2,751 |
|
|
|
|
1,762 |
|
|
|
|
4,786 |
|
|
|
|
3,380 |
|
Research and development |
|
|
11,109 |
|
|
|
|
6,878 |
|
|
|
|
21,671 |
|
|
|
|
10,561 |
|
Selling, general and
administrative |
|
|
26,121 |
|
|
|
|
23,336 |
|
|
|
|
51,281 |
|
|
|
|
42,737 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total costs and
expenses |
|
|
39,981 |
|
|
|
|
31,976 |
|
|
|
|
77,738 |
|
|
|
|
56,678 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating income |
|
|
10,440 |
|
|
|
|
3,076 |
|
|
|
|
15,757 |
|
|
|
|
6,507 |
|
Other income
(expense) |
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
363 |
|
|
|
|
137 |
|
|
|
|
694 |
|
|
|
|
250 |
|
Interest expense |
|
|
(196 |
) |
|
|
|
(331 |
) |
|
|
|
(375 |
) |
|
|
|
(712 |
) |
Changes in fair value of derivative
liabilities |
|
|
123 |
|
|
|
|
1 |
|
|
|
|
224 |
|
|
|
|
(48 |
) |
Loss on extinguishment of debt |
|
|
— |
|
|
|
|
(241 |
) |
|
|
|
(382 |
) |
|
|
|
(2,375 |
) |
Other income (expense) |
|
|
2 |
|
|
|
|
25 |
|
|
|
|
(1 |
) |
|
|
|
25 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total other income
(expense) |
|
|
292 |
|
|
|
|
(409 |
) |
|
|
|
160 |
|
|
|
|
(2,860 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Earnings before income
taxes |
|
|
10,732 |
|
|
|
|
2,667 |
|
|
|
|
15,917 |
|
|
|
|
3,647 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Income tax expense |
|
|
714 |
|
|
|
|
662 |
|
|
|
|
912 |
|
|
|
|
724 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
$ |
|
10,018 |
|
|
$ |
|
2,005 |
|
|
$ |
|
15,005 |
|
|
$ |
|
2,923 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Income per common
share: |
|
|
|
|
|
|
|
|
|
|
|
Basic |
$ |
|
0.20 |
|
|
$ |
|
0.04 |
|
|
$ |
|
0.30 |
|
|
$ |
|
0.06 |
|
Diluted |
$ |
|
0.18 |
|
|
$ |
|
0.03 |
|
|
$ |
|
0.28 |
|
|
$ |
|
0.06 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average number
of common shares: |
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
|
49,427,825 |
|
|
|
|
47,911,932 |
|
|
|
|
49,333,962 |
|
|
|
|
46,246,866 |
|
Diluted |
|
|
51,745,342 |
|
|
|
|
52,273,549 |
|
|
|
|
51,484,686 |
|
|
|
|
47,687,992 |
|
|
|
|
|
|
|
|
|
|
|
|
|
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
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