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 provided the following business update.
Commercial Update
Third quarter 2016 product prescriptions for Trokendi XR® and
Oxtellar XR®, as reported by IMS, totaled 131,408, a 30.4% increase
over the third quarter of 2015.
|
Prescriptions |
|
|
|
|
Q3 2016 |
Q3 2015 |
|
Change % |
|
|
|
|
|
|
|
Trokendi XR |
|
|
99,049 |
|
|
75,104 |
|
|
|
31.9 |
% |
|
Oxtellar XR |
|
|
32,359 |
|
|
25,666 |
|
|
|
26.1 |
% |
|
|
|
|
|
|
|
|
Total |
|
|
131,408 |
|
|
100,770 |
|
|
|
30.4 |
% |
|
Source: IMS
Net product sales for the third quarter of 2016 were $55.6
million, a 44.1% increase over $38.6 million in the same period
last year.
|
Net Product Sales
($mil.) |
|
|
Q3 2016 |
Q3 2015 |
|
Change % |
|
|
|
|
|
|
|
Trokendi XR |
|
$ |
41.7 |
|
$ |
29.9 |
|
|
|
39.4 |
% |
|
Oxtellar XR |
|
$ |
13.9 |
|
$ |
8.7 |
|
|
|
60.1 |
% |
|
|
|
|
|
|
|
|
Total |
|
$ |
55.6 |
|
$ |
38.6 |
|
|
|
44.1 |
% |
|
“Supernus achieved another quarter of strong growth in product
prescriptions and net sales, which reflects the strong underlying
demand for our epilepsy products,” said Jack Khattar, President and
CEO of Supernus Pharmaceuticals. “We are pleased with the progress
we have made towards meeting our 2016 goals, reaching year-to-date
net product sales of $149.0 million, a 48% increase over the same
period last year.”
In August 2016, the Food and Drug Administration (FDA) granted
tentative approval to the Company's Supplemental New Drug
Application requesting a label expansion for Trokendi XR to include
prophylaxis of migraine headache in adults. The Company continues
to prepare for and will be ready to launch the migraine indication
soon after receiving full FDA approval.
Progress of Product Pipeline
Enrollment continues in 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. As previously discussed, steps
were taken this year to improve patient enrollment and retention.
Preliminary results indicate that improvement has been made. The
Company has partnered with an enrollment and retention agency to
facilitate identifying, contacting, and prescreening appropriate
patients for the clinical trials, and to assist in scheduling
patients for their appointments and follow-up visits. In addition,
the patient screening period for the Phase III trials has been
lengthened, and increased education has been provided for site
coordinators and caregivers about the trial protocol. The Company
expects recruitment and retention to continue to improve as these
steps become fully implemented. Enrollment is expected to continue
into 2017.
Regarding SPN-812, currently in development for patients aged 6
to 12 years with ADHD, the Company announced in October positive
topline results from its Phase IIb clinical trial in children with
ADHD. The trial met its primary endpoint, demonstrating that
SPN-812 at daily doses of 400 mg, 300 mg, and 200 mg achieved a
statistically significant improvement in the symptoms of ADHD from
baseline to end of study as measured by the ADHD Rating Scale-IV.
All SPN-812 doses tested in the trial were well tolerated. Supernus
plans to have an end-of-Phase II meeting with the FDA after which
it will initiate Phase III clinical testing.
“Given all the data generated to date, we expect SPN-812 to be a
differentiated ADHD product that is a highly effective
non-stimulant with a tolerable side effect profile,” said Jack
Khattar. “Our plan is to meet with the FDA and move forward as
quickly as we can into a Phase III program.”
Operating Expenses
Research and development expenses in the third quarter of 2016
were $7.9 million, as compared to $9.1 million in the same quarter
last year. This decrease is primarily due to the completion of
enrollment in the Phase IIb trial for SPN-812. The Company expects
research and development expenses to increase for the remainder of
2016. Total research and development expenses in 2017 are expected
to range from approximately $50 million to $60 million and will
depend on the timing of key research and development projects,
including initiation of two Phase III studies for SPN-812 and
patient recruitment in the Phase III trials for SPN-810.
Selling, general and administrative expenses in the third
quarter of 2016 were $25.7 million, as compared to $22.9 million in
the same quarter last year. The increase is primarily due to the
continued efforts in support of the Company’s commercial
products.
Capital Resources
As of September 30, 2016, the Company had $147.4 million in
cash, cash equivalents, marketable securities, and long term
marketable securities, as compared to $117.2 million at December
31, 2015. As of September 30, 2016, approximately $6.6 million of
the Company’s six year, $90 million notes, bearing interest at 7.5%
per annum, remain outstanding.
Recent Form 8-K Filing by Company
As discussed in the Form 8-K filed by the Company on November
14, 2016, the Company was unable to timely file its Quarterly
Report on Form 10-Q (the “Quarterly Report”) for the three
months ended September 30, 2016 due to an issue that has
arisen concerning the accounting treatment of the $30 million
royalty monetization transaction entered into by the Company in
July 2014. In addition, the Company will restate
financial statements for the years ended December 31, 2014 and
December 31, 2015, and the interim quarterly reports in those
years beginning with the third quarter of 2014, and the interim
quarterly reports for the first and second quarters in 2016.
At this time, all the changes necessary to restate the financial
statements for these periods are not complete. However, the
Company does not expect the restatement to impact the Company’s net
product sales, operating expenses, or capital resources for the
periods ended December 31, 2014 and 2015. As discussed in this
update, investors should refer to the Form 8-K for a complete
discussion of the potential effects of the restatement.
Financial Guidance
As set forth in the Company’s Form 8-K filed on November 14,
2016, the Company’s current guidance for full year 2016 for net
product sales, research and development (“R&D”) expenses and
operating income is as set forth below:
- Net product sales in the range of $205 million to $210 million,
compared to the previously expected range of $200 million to $210
million.
- R&D expenses in the range of $40 million to $44 million,
compared to the previously expected range of $50 million to $55
million.
- Taking into consideration the anticipated effects of the
restatement referred to above (approximately $4 million to $6
million) for the full year 2016, operating income would range from
$46 million to $51 million. Excluding the anticipated effect of the
restatement, operating income would range from $42 million to $47
million, compared to the previously expected range of $32 million
to $37 million.
Cash generated from operations in the nine months ended
September 30, 2016, was $37.6 million, as compared to $12.1 million
in the same period last year.
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 identification of additional information relevant
to the ongoing accounting review; changes in the scope or focus of
the accounting adjustments related to such review; the conclusions
of the Audit Committee (and the timing of the conclusions)
concerning matters relating to the ongoing accounting review; the
timing of the review by, and the conclusions of, the Audit
Committee, the Board and the Company’s independent public
accounting firm regarding the accounting review and the Company’s
financial statements; the determination of additional adjustments
for the periods to be restated; the risk that the completion and
filing of the amended reports will take longer than expected; 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.
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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