- First quarter product prescriptions, as reported by IMS,
totaled 30,208, increasing by 9,098, or 43%, as compared to fourth
quarter 2013.
- First quarter combined net product revenue for Oxtellar XR and
Trokendi XR was $9.0 million.
- As of May, the sales force expansion is substantially complete,
totaling more than 150 representatives.
- Operating loss in the first quarter was $13.4 million, as
compared to $11.4 million in the fourth quarter of 2013, reflecting
costs associated with the expansion of the sales force.
Supernus Pharmaceuticals, Inc. (Nasdaq:SUPN), a specialty
pharmaceutical company focused on developing and commercializing
products for the treatment of central nervous system diseases,
today reported financial results for the first quarter 2014 and
discussed key company developments.
Business Update
First quarter product prescriptions, as reported by IMS, totaled
30,208, increasing by 9,098, or 43%, as compared to fourth quarter
2013. Trokendi XR prescriptions for the first quarter of 2014
totaled 18,727, representing a 66.6% increase over the 11,244
prescriptions in the fourth quarter of 2013. Prescriptions for
Oxtellar XR during the first quarter of 2014 totaled 11,481, a
16.4% increase over the 9,866 prescriptions filled during the
fourth quarter of 2013.
As of May 2014, the expansion of the sales force to more than
150 representatives is substantially complete. The number of sales
calls delivered to targeted physicians accordingly grew by more
than 20% from fourth quarter 2013 to first quarter 2014. The
Company expects the number of sales calls to increase as our sales
force expansion takes effect.
Managed care coverage continues to increase for both products.
Oxtellar XR now has 150.3 million lives covered (129.7 million
commercial; 20.6 million Medicaid), and Trokendi XR has 143.8
million lives covered (116.1 million commercial; 27.7 million
Medicaid).
"Our commercial team continues to execute very well on our
product launches," said Jack Khattar, President and CEO of Supernus
Pharmaceuticals, Inc. "As reported by IMS, prescriptions for the
two products combined in the most recent four weeks ending May 2,
2014 were 12,069 representing a growth rate of 50% compared to
8,049 total prescriptions in the first four weeks of the year. The
recent expansion of our sales force provides us with great momentum
toward reaching the monthly prescription rate of approximately
30,000, that will allow us to become cash flow break-even by year
end."
Revenue and Gross Margin
Revenues for Trokendi XR increased to $4.1 million during the
first quarter of 2014, based on the 11,244 prescriptions
filled during the fourth quarter of 2013. This compares to
$0.4 million recorded during the fourth quarter of 2013, based on
1,314 prescriptions filled at the pharmacy level during the third
quarter of 2013.
Oxtellar XR revenue for the first quarter of 2014, based on
shipments to wholesalers, was $4.9 million, representing an
increase of $1.1 million or 29% as compared to shipments in the
fourth quarter of 2013.
Gross margin for the first quarter of 2014 was 94.5%, an
increase from the fourth quarter 2013 gross margin of 89.6%.
Operating Expenses
Selling, general and administrative expenses for the first
quarter 2014 were $17.5 million, as compared to $13.5 million in
the first quarter 2013. The higher expense reflected the sales
force expansion and promotional and marketing related programs in
support of Trokendi XR and Oxtellar XR.
Research and development expenses during the first quarter 2014
were $4.5 million, essentially unchanged from prior year.
Net Income and Earnings Per Share
The reported net loss for the first quarter 2014 was $15.5
million, or $0.38 per share, as compared to $18.4 million, or $0.60
per share, reported for the first quarter 2013. The lower net loss
during the period reflects higher revenues generated from the
Company's commercialized products, Oxtellar XR and Trokendi XR,
which were launched February 2013 and August 2013, respectively.
Net product revenues generated during the period were offset by
expenses related to the sales force expansion, increased marketing
and commercialization activities, and the non-cash loss on
extinguishment of debt.
The weighted average common shares outstanding in the first
quarter 2014 were approximately 41.1 million, as compared to
approximately 30.9 million in 2013.
As of March 31, 2014, $50.0 million of the Company's six year
notes, bearing interest at 7.5% per annum, have been converted to
common stock. Excluding a non-cash gain of $0.7 million
related to changes in the fair value of derivative liabilities and
a $1.7 million loss on extinguishment of debt consequent to
conversion of the Company's notes, the non-GAAP net loss for first
quarter of 2014 was $14.5 million.
Capital Resources and Financial Guidance
As of March 31, 2014, the Company had $70.5 million in cash,
cash equivalents, marketable securities, and long term marketable
securities compared to approximately $90.9 million as of December
31, 2013. Cash burn for full year 2014 is forecast to range
from $35 million to $45 million, with year-end cash and marketable
securities balance projected to range from $45 million to $55
million. Upon becoming cash flow break-even by year end 2014,
the Company projects to be cash flow positive in 2015.
The Company anticipates that revenue recognition for Trokendi XR
will transition to contemporaneous revenue recognition, based on
shipments to wholesalers, during 2014. Assuming
this occurs, the Company expects revenue for calendar year 2014 to
be in the range of $75 million to $85 million. If the
transition occurs in the second quarter, reported revenue for
Trokendi XR will include revenue generated from prescriptions
filled in both the first and second quarters of 2014, as well as
product in the wholesaler distribution channel as of June 30, 2014.
Deferred revenue for Trokendi XR, as recorded on the balance sheet,
would be eliminated.
Progress of Product Candidates
The Company's product candidates currently in development,
SPN-810 for impulsive aggression in patients with ADHD and SPN-812
for ADHD, are progressing on schedule. SPN-810 is being developed
in cooperation with the FDA as a first-in-class product for an
indication with a significant unmet clinical need. In
conjunction with technology transfer to a commercial scale
manufacturer, the Company has initiated full-scale production of
SPN-810 formulation. SPN-810 is scheduled to start Phase III
patient dosing in 2015.
SPN-812 formulation development also continues to progress on
schedule and the Company expects to select an extended release
formulation during 2014. In addition, both pipeline programs
continue to progress animal carcinogenicity and toxicity
studies.
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
9:00am EDT, on Tuesday, May 13, 2014. An accompanying webcast will
also 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: |
35887259 |
Conference Call Name: |
Supernus Pharmaceuticals 1Q 2014 Earnings
Conference Call |
|
Following the live call, a replay will be available on the
Company's website, www.supernus.com, under "Investor Info".
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 in psychiatry to address large market opportunities in
ADHD, including ADHD patients with impulsive aggression. These
product candidates include SPN-810 for impulsive aggression in ADHD
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 achieve 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) |
|
|
March 31, 2014 |
December 31,
2013 |
|
(unaudited) |
|
|
|
|
Cash, cash equivalents and marketable
securities |
$ 58,867 |
$ 82,191 |
Accounts receivable, net |
9,725 |
5,054 |
Inventories |
7,957 |
7,152 |
Other current assets |
3,380 |
2,764 |
Total Current Assets |
79,929 |
97,161 |
|
|
|
Property and equipment, net |
2,648 |
2,554 |
Long term marketable securities |
11,662 |
8,756 |
Deferred financing costs |
764 |
1,005 |
Other long-term assets |
2,517 |
1,519 |
Total Assets |
$ 97,520 |
$ 110,995 |
|
|
|
Accounts payable and accrued expenses |
$ 14,658 |
$ 18,314 |
Deferred product revenue, net |
12,271 |
7,882 |
Deferred licensing revenue |
173 |
204 |
Total Current Liabilities |
27,102 |
26,400 |
|
|
|
Deferred licensing revenue, net of current
portion |
1,381 |
1,417 |
Convertible notes, net of discount |
28,358 |
34,393 |
Other non-current liabilities |
2,101 |
2,677 |
Derivative liabilities |
9,565 |
12,644 |
Total Liabilities |
68,507 |
77,531 |
|
|
|
Total Stockholders' Equity |
29,013 |
33,464 |
Total Liabilities & Stockholders
Equity |
$ 97,520 |
$ 110,995 |
|
|
Supernus
Pharmaceuticals, Inc. |
Consolidated Statements
of Operations |
(in thousands, except
share and per share data) |
|
|
Three Months
ended March 31, |
|
2014 |
2013 |
|
(unaudited) |
|
|
|
Revenue |
|
|
Net product sales |
$ 8,995 |
$ -- |
Licensing revenue |
86 |
147 |
|
|
|
Total revenue |
9,081 |
147 |
|
|
|
Costs and expenses |
|
|
Cost of product sales |
494 |
-- |
Research and development |
4,482 |
4,522 |
Selling, general and
administrative |
17,527 |
13,533 |
|
|
|
Total costs and expenses |
22,503 |
18,055 |
|
|
|
Operating loss |
(13,422) |
(17,908) |
|
|
|
Other income (expense) |
|
|
Interest income and other
income (expense), net |
102 |
141 |
Interest expense |
(1,207) |
(727) |
Changes in fair value of
derivative liabilities |
677 |
80 |
Loss on extinguishment of
debt |
(1,693) |
-- |
|
|
|
Total other (expense) income |
(2,121) |
(506) |
|
|
|
Net loss |
$ (15,543) |
$ (18,414) |
|
|
|
Loss per common share: |
|
|
Basic and diluted |
$ (0.38) |
$ (0.60) |
|
|
|
Weighted-average number of common
shares: |
|
|
Basic and diluted |
41,129,055 |
30,875,424 |
|
|
Supernus
Pharmaceuticals, Inc. |
Reconciliation of
Non-GAAP Net Loss |
(in
thousands) |
|
|
Three Months
ended March 31, |
|
2014 |
2013 |
|
(unaudited) |
|
|
|
Net Loss - GAAP |
$ (15,543) |
$ (18,414) |
|
|
|
Changes in fair value of
derivative liabilities |
677 |
80 |
Loss on extinguishment of
debt |
(1,693) |
-- |
|
|
|
Adjusted Net Loss - non-GAAP |
$ (14,527) |
$ (18,494) |
CONTACT: Jack A. Khattar, President and CEO
Gregory S. Patrick, Vice President and CFO
Supernus Pharmaceuticals, Inc.
301-838-2591
or
INVESTOR CONTACT:
COCKRELL GROUP
877-889-1972
investorrelations@thecockrellgroup.com
cockrellgroup.com
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