Supernus Pharmaceuticals Reports Fourth Quarter 2012 and Full Year 2012 Financial Results
Supernus Pharmaceuticals Reports Fourth Quarter 2012 and Full Year 2012
Financial Results
ROCKVILLE, Md., March 14, 2013 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals,
Inc. (Nasdaq:SUPN), a specialty pharmaceutical company, today reported
financial results for the three and twelve months ended December 31, 2012, and
provided an update on key accomplishments to date.
* Successfully transitioned from a development stage private company to a
publicly traded, commercial pharmaceutical company. Our initial public
offering raised gross proceeds totaling $52 million and the follow-on
public offering raised an additional $48 million.
* Built our commercial organization including an experienced sales and
marketing team in preparation for the launch of our lead epilepsy product
Oxtellar XR^TM (extended-release oxcarbazepine) which was approved by the
FDA in October, and for which we received confirmation from the FDA that
it has been granted 3-years marketing exclusivity.
* Received tentative approval in June for Trokendi XR^TM (extended-release
topiramate), and in October announced that the USPTO issued two patents
covering the product.
* Continued to develop our pipeline through the successful completion of a
Phase IIb trial with positive top line results on SPN-810, our novel
treatment for impulsive aggression in ADHD patients.
"Looking forward into 2013, we are excited about our recent launch of Oxtellar
XR^TM and the upcoming launch of Trokendi XR^TM in the third quarter of the
year. Our sales force is now fully engaged in promoting Oxtellar XR^TM to high
prescribing physicians. We have made excellent progress in placing Oxtellar
XR^TM on managed care formularies and distributing Oxtellar XR^TM through the
wholesaler network," said Jack Khattar, President and CEO of Supernus
Pharmaceuticals, Inc.
Fourth Quarter 2012 Financial Results
* Cash, cash equivalents and marketable securities of $88.5 million at
December 31, 2012.
* Research and development (R&D) expense for the fourth quarter declined
from $7.5 million in 2011 to $5.2 million in 2012 due to lower clinical
trial costs for Oxtellar XR^TM.
* Selling, general and administrative (SG&A) expense for the fourth quarter
increased from $2.8 million in 2011 to $8.7 million in 2012, reflecting
higher sales and marketing expenses in anticipation of the 2013 launch of
Oxtellar XR^TM and Trokendi XR^TM.^
* Net loss applicable to common shareholders for fourth quarter 2012 was
$13.5 million or $0.51 per common share (based on 26.6 million weighted
average diluted shares outstanding), compared to a gain of $81.1 million
in the fourth quarter of 2011 or $40.14 per common share (based on 2.0
million weighted average diluted shares outstanding). The gain in the
fourth quarter 2011 was due to the sale of the TCD Royalty subsidiary
("TCD"), which is reported as a discontinued operation. Excluding the
impact of the sale of TCD, net loss for the fourth quarter of 2011 was
$10.6 million.
Twelve months ended December 31, 2012 Financial Results
* R&D expense for 2012 declined from $30.6 million in 2011 to $23.5 million,
primarily due to the conclusion of the Oxtellar XR^TM and Trokendi XR^TM
clinical trials in 2011.
* SG&A expense for 2012 increased from $7.9 million in 2011 to $20.1
million, primarily because of higher sales and marketing costs associated
with preparing for the 2013 launches of Oxtellar XR^TM and Trokendi XR^TM.
* Net loss applicable to common shareholders for 2012 was $47.4 million or
$2.72 per common share (based on 17.4 million weighted average diluted
shares outstanding), compared to a net income of $50.4 million, or $31.39
per common share, for 2011 (based on 1.6 million weighted average diluted
shares outstanding). The gain in 2011 was due to the sale of TCD, which
is reported as a discontinued operation. Excluding the impact of the sale
of TCD, net loss for 2011 was $39.5 million.
Liquidity and Capital Resources
Cash, cash equivalents and marketable securities increased from $48.5 million
at December 31, 2011 to $88.5 million at December 31, 2012. This increase was
the result of net proceeds from our common stock offerings during 2012 of
$92.4 million offset by uses of cash in 2012 to fund operations and service
debt payments.
Oxtellar XR^TM Launch Update
Oxtellar XR^TM was launched in February 2013 by approximately 75 sales
representatives focusing on the top 6 deciles of high prescribing
physicians. All major wholesalers and several regional wholesalers in the
United States have stocked the product, and the Company has a pharmacy
assistance service to assist patients in finding a local pharmacy that can
quickly order the product and fill their prescription. To date, Oxtellar XR^TM
has achieved strong coverage on commercial managed care formularies with more
than 120 million commercial lives. Initial feedback from the field, while very
early into the launch, has been very positive about Oxtellar XR^TM. The
Company should be in a much better position to look at prescription data as it
gets further into the launch.
2013 Financial Guidance
In order to support both product launches and the continued development of our
pipeline, we project cash burn for the year to range from $95 million to $105
million. We believe our cash, cash equivalents, and marketable securities as
of December 31, 2012 should be sufficient to fund operations into the fourth
quarter of 2013.
Assuming availability of data on rebates and allowances, the Company may be
able to report revenue for Oxtellar XR^TM prescriptions which are sold in the
first quarter in its second quarter financial results.
About Oxtellar XR^TM
Oxtellar XR^TM is a novel once-daily extended release formulation of
oxcarbazepine. It is an antiepileptic drug (AED) indicated for adjunctive
therapy in the treatment of partial seizures in adults and in children 6 to 17
years of age. The recommended daily dose for adults is 1200 mg to 2400 mg once
per day, and for children 6 to 17 years of age is 900 mg to 1800 mg depending
on weight. The product is available in 150 mg, 300 mg and 600 mg
extended-release tablets.
For full prescribing and safety information, click here.
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 launched one product for
epilepsy, Oxtellar XR^TM (extended release oxcarbazepine), and has one
tentatively approved product for epilepsy, Trokendi XR^TM (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
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 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 respective PDUFA dates for
product candidates and anticipated launch dates for its tentatively approved
product; 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)
(unaudited)
December 31, 2011 December 31, 2012
Cash, cash equivalents and marketable $48,544 $88,508
securities
Other current assets 855 3,233
Total current assets 49,399 91,741
Property and equipment, net 1,310 1,421
Deferred financing costs 2,054 89
Other long-term assets 967 738
Total Assets $53,730 $93,989
Accounts payable and accrued expenses $11,763 $10,666
Secured notes payable, current 6,775 11,809
Deferred revenue 232 508
Total current liabilities 18,770 22,983
Secured notes payable, long-term 22,711 11,088
Other liabilities 2,806 2,348
Total Liabilities 44,287 36,419
Total Stockholders' Equity 9,443 57,570
Total Liabilities & Stockholders Equity $53,730 $93,989
SUPERNUS PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share data)
(unaudited)
Three months ended Year ended
December December 31, December 31, December 31,
31, 2011 2012 2011 2012
Revenues $42 $1,090 $803 $1,480
Cost and expenses
Research and development 7,500 5,150 30,627 23,517
Selling, general and 2,785 8,684 7,928 20,132
administrative
Total cost and expenses 10,285 13,834 38,555 43,649
Operating loss (10,243) (12,744) (37,752) (42,169)
Other income (expense):
Interest income 0 30 31 120
Interest expense (508) (804) (1,866) (3,575)
Other income(expense) 87 6 117 (660)
Loss from continuing
operations before income (10,664) (13,512) (39,470) (46,284)
taxes
Income tax benefit 16,245 -- 16,245 --
Income (loss) from 5,581 (13,512) (23,225) (46,284)
continuing operations
Income from discontinued 1,542 -- 2,188 --
operations, net of tax
Gain on disposal of
discontinued operations, 74,852 -- 74,852 --
net of tax
Income from discontinued 76,394 -- 77,040 --
operations
Net income (loss) 81,975 (13,512) 53,815 (46,284)
Cumulative dividends on (858) -- (3,430) (1,143)
preferred stock
Net income (loss)
attributable to common $81,117 ($13,512) $50,385 ($47,427)
shareholders
Net income (loss) per
common share:
Basic
Continuing operations $2.88 ($0.51) ($16.60) ($2.72)
Discontinued operations 46.64 -- 47.99 --
Net income (loss) $49.52 ($0.51) $31.39 ($2.72)
Net income (loss) per
common share: discontinued
Diluted
Continuing operations $2.34 ($0.51) ($16.60) ($2.72)
Discontinued operations 37.80 -- 47.99 --
Net income (loss) $40.14 ($0.51) $31.39 ($2.72)
Weighted-average number of
common shares:
Basic 1,638,076 26,626,949 1,605,324 17,440,910
Diluted 2,020,874 26,626,949 1,605,324 17,440,910
CONTACT: Jack Khattar, President & CEO
Gregory S. Patrick, Vice President and CFO
Supernus Pharmaceuticals, Inc.
Tel: (301) 838-2591
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