ROCKVILLE, Md., Aug. 13, 2013 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (Nasdaq:SUPN), a specialty pharmaceutical company, today reported financial results for the three and six months ended June 30, 2013, and provided an update on key accomplishments to date.
"Oxtellar XRTM continues to impress us with its clinical performance in the market. Prescribers are highly satisfied with the product and patients appreciate its key benefits. We are pleased with continued growth in the prescriber base and monthly prescriptions as we head into the middle of the third quarter. We also remain excited about our preparations for the upcoming launch of Trokendi XRTM later this quarter," said Jack Khattar, President and CEO of Supernus Pharmaceuticals, Inc.
Second Quarter 2013 Financial Results
Six Months Ended June 30, 2013 Financial Results
Financial Update
Liquidity and Capital Resources
Oxtellar XR™ Launch Update
Pipeline Update
Regarding Trokendi XRTM, we continue to expect receiving final approval and commercially launching Trokendi XRTM in the third quarter of 2013.
Finally, regarding the rest of the pipeline, we continue to progress SPN 810 with the goal of having a meeting with the FDA by year end to discuss with them our plans for later stage clinical studies and to progress SPN 812 with the development of a novel once daily formulation to be used later in a phase IIb study.
2013 Financial Guidance
We continue to project cash burn for the year to range from $85 million to $95 million. For the six month period ending June 30, 2013 cash burn was $39.1 million. We believe our cash, cash equivalents, and marketable securities as of June 30, 2013, should be sufficient to fund operations through the end of 2014, by which time we expect to be cash flow break even.
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 one marketed product for epilepsy, Oxtellar XRTM (extended release oxcarbazepine), and one tentatively approved product for epilepsy, Trokendi XRTM (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) | ||
June 30, 2013 | December 31, 2012 | |
(unaudited) | ||
Cash, cash equivalents and marketable securities | $102,632 | $88,508 |
Accounts receivable | 537 | -- |
Inventories | 4,315 | 1,152 |
Other current assets | 3,132 | 1,802 |
Total current assets | 110,617 | 91,462 |
Property and equipment, net | 2,247 | 1,421 |
Deferred financing costs | 2,109 | 89 |
Long term investments | 16,072 | -- |
Other long-term assets | 928 | 1,017 |
Total Assets | $131,973 | $93,989 |
Accounts payable and accrued expenses | $11,732 | $10,666 |
Deferred product revenue | $3,967 | -- |
Deferred licensing revenue | 325 | 508 |
Secured notes payable, current | -- | 11,809 |
Total current liabilities | 16,024 | 22,983 |
Deferred licensing revenue, net of current portion | 738 | 309 |
Convertible notes, net of discount | 59,100 | -- |
Secured notes payable, long-term | -- | 11,088 |
Other non-current liabilities | 2,158 | 1,788 |
Derivative liabilities | 18,061 | 251 |
Total Liabilities | 96,081 | 36,419 |
Total Stockholders' Equity | 35,892 | 57,570 |
Total Liabilities & Stockholders Equity | $131,973 | $93,989 |
Supernus Pharmaceuticals, Inc. | ||||
Consolidated Statements of Operations | ||||
(in thousands, except share and per share data) | ||||
Three Months ended June 30, | Six Months ended June 30, | |||
2013 | 2012 | 2013 | 2012 | |
(unaudited) | (unaudited) | |||
Revenue | ||||
Net product sales | $154 | $— | $154 | $— |
Licensing revenue | 127 | 91 | 274 | 299 |
Total revenue | 281 | 91 | 428 | 299 |
Costs and expenses | ||||
Cost of product sales | 4 | — | 4 | — |
Research and development | 3,542 | 4,703 | 8,065 | 10,061 |
Selling, general and administrative | 12,214 | 4,645 | 25,747 | 7,374 |
Total costs and expenses | 15,760 | 9,348 | 33,816 | 17,435 |
Operating loss | (15,479) | (9,257) | (33,388) | (17,136) |
Other income (expense) | ||||
Interest income and other income (expense), net | 47 | 317 | 191 | 211 |
Interest expense | (2,144) | (929) | (2,872) | (1,891) |
Changes in fair value of derivative liabilities | (8,619) | (144) | (8,540) | (472) |
Loss on extinguishment of debt | (1,162) | — | (1,162) | — |
Total other (expense) income | (11,878) | (756) | (12,383) | (2,152) |
Net loss | (27,357) | (10,013) | (45,771) | (19,288) |
Cumulative dividends on Series A convertible preferred stock | — | (286) | — | (1,143) |
Net loss attributable to common stockholders | $(27,357) | $(10,299) | $(45,771) | $(20,431) |
Loss per common share: | ||||
Basic and diluted | $(0.89) | $(0.61) | $(1.48) | $(2.21) |
Weighted-average number of common shares: | ||||
Basic and diluted | 30,897,075 | 16,817,841 | 30,886,309 | 9,247,142 |
The following is a reconciliation of the non-GAAP financial measures used by the Company to describe its financial results determined in accordance with GAAP.
Supernus Pharmaceuticals, Inc. | ||
Reconciliation of Non-GAAP Net Loss | ||
(in thousands) | ||
Three Months | Six Months | |
ended June 30, | ended June 30, | |
2013 | 2013 | |
(unaudited) | ||
Net loss - GAAP | $(27,357) | $(45,771) |
Changes in fair value of derivative liabilities | (8,619) | (8,540) |
Loss on extinguishment of debt | (1,162) | (1,162) |
Adjusted Net Loss - non-GAAP | $(17,576) | $(36,069) |