Supernus Announces Record Fourth Quarter and Full Year 2015 Financial Results
- Net product sales for fourth quarter 2015 were
$42.6 million , a 39.6% increase over the same quarter of 2014 and a 10.5% increase over third quarter 2015.
- Net product sales for full year 2015 were
$143.5 million , a 60.2% increase over full year 2014.
- Operating income for fourth quarter 2015 was
$6.8 million , a 44.8% increase over operating income of$4.7 million in the same quarter of 2014.
- Achieved first full year of profitability from on-going operations in 2015, with operating income of
$17.7 million . Excluding the impact of a onetime$30.0 million royalty monetization payment in the third quarter of 2014, operating loss was$5.8 million for full year 2014.
- Finalized the special protocol
assessment (SPA) for the SPN-810 Phase III trial with the
FDA in the fourth quarter of 2015. The Company remains on schedule with the Phase III program for SPN-810 for the treatment of Impulsive Aggression in ADHD and the Phase IIb program for SPN-812 for the treatment of ADHD.
Commercial Update
Fourth quarter 2015 product prescriptions for Trokendi XR® and Oxtellar XR®, as reported by IMS, totaled 111,627, a 61.3% increase over the fourth quarter of 2014 and an increase of 10.8% over the third quarter of 2015. Full year 2015 product prescriptions for Trokendi XR® and Oxtellar XR® totaled 378,173, a 90.6% increase over full year 2014.
| Prescriptions | Increase in Prescriptions (%) | |||||||||||||
| Q4 2015 | Q3 2015 | Q4 2014 | Q4 15 vs. Q3 15 | Q4 15 vs. Q4 14 | ||||||||||
| Trokendi XR | 83,899 | 75,104 | 49,220 | 11.7 | % | 70.5 | % | |||||||
| Oxtellar XR | 27,728 | 25,666 | 19,988 | 8.0 | % | 38.7 | % | |||||||
| Total | 111,627 | 100,770 | 69,208 | 10.8 | % | 61.3 | % | |||||||
| Prescriptions | Increase in Prescriptions (%) | |||||||||||||
| FY 2015 | FY 2014 | FY 2015 vs. FY 2014 | ||||||||||||
| Trokendi XR | 279,782 | 135,238 | 106.9 | % | ||||||||||
| Oxtellar XR | 98,391 | 63,153 | 55.8 | % | ||||||||||
| Total | 378,173 | 198,391 | 90.6 | % | ||||||||||
Source: Product prescriptions as reported by IMS
"2015 was a year of significant achievements,
where we delivered on our commercial strategy for Trokendi XR and Oxtellar XR, and progressed our pipeline into late-stage clinical testing," said
Progress of Product Pipeline
The Company remains on schedule with its two Phase III trials for SPN-810 and the Phase IIb trial for SPN-812. During the first quarter, we are actively recruiting and screening patients for all trials. Phase III data for SPN-810 is expected to be available by mid 2017, and data from the SPN-812 Phase IIb trial is expected to be available by early 2017.
During the fourth quarter of 2015, the Company finalized the SPA for SPN-810 with the
Regarding SPN-812, during the fourth quarter of 2015 final results were received from a single-ascending dose (SAD) study and a multiple-ascending dose (MAD) study in adult healthy volunteers. These data showed an overwhelmingly favorable adverse event profile for our extended-release formulation at doses that are several multiples of the effective doses used in the immediate release formulation in the Phase IIa study.
"We are very excited about the emerging clinical profile of SPN-812. Data from our SAD and MAD studies reinforce our belief that SPN-812 has the potential for being dosed at levels high enough to compare favorably with stimulant medications for efficacy, while still showing a favorable tolerability and safety profile," said
Revenues and Gross Margin
Net product sales for the fourth quarter of 2015 were
| Net Product Sales ($mil.) | Increase in Net Product Sales (%) | ||||||||||||||||||||
| Q4 2015 | Q3 2015 | Q4 2014 | Q4 15 vs. Q3 15 | Q4 15 vs. Q4 14 | |||||||||||||||||
| Trokendi XR | $ | 33.3 | $ | 29.9 | $ | 22.9 | 11.4 | % | 45.5 | % | |||||||||||
| Oxtellar XR | $ | 9.3 | $ | 8.7 | $ | 7.6 | 6.9 | % | 22.4 | % | |||||||||||
| Total | $ | 42.6 | $ | 38.6 | $ | 30.5 | 10.5 | % | 39.6 | % | |||||||||||
| Net Product Sales ($mil.) | Increase in Net Product Sales (%) | ||||||||||||||||||||
| FY 2015 | FY 2014 | FY 2015 vs. FY 2014 | |||||||||||||||||||
| Trokendi XR | $ | 110.3 | $ | 64.9 | 70.1 | % | |||||||||||||||
| Oxtellar XR | $ | 33.2 | $ | 24.7 | 34.4 | % | |||||||||||||||
| Total | $ | 143.5 | $ | 89.6 | 60.2 | % | |||||||||||||||
Total revenue for full year 2015 was
Gross margin was 93.4% and 94.1% for the fourth quarter and full year 2015, respectively, compared to 92.5% and 93.6% for the comparable periods in 2014.
Operating Expenses
Research and development expenses in the fourth quarter of 2015 were
Selling, general and administrative expenses in the fourth quarter of 2015 were
Operating Income and Earnings Per Share
For the first time, the Company was profitable from ongoing operations for the full year as well as in each quarter of the year. Operating income in the fourth quarter of 2015 was
Diluted earnings per share were
Weighted-average diluted common shares outstanding were approximately 49.6 million and 51.2 million in the fourth quarter and full year of 2015, respectively, as compared to approximately 43.2 million and 50.6 million in the respective periods the prior year.
Capital Resources
As of
Financial Guidance
For full year 2016, the Company estimates that net product sales will range from
The Company expects that research and development expenses in 2016 will range from
Conference Call Details
The Company will hold a conference call hosted by
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: 47017444
Conference Call Name:
Following the live call, a replay will be available on the Company's website, www.supernus.com, under ‘Investors'.
About
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
| Condensed Consolidated Balance Sheets | ||||||
| (in thousands) | ||||||
| (unaudited) | ||||||
| Cash, cash equivalents and marketable securities | $ | 62,190 | $ | 74,336 | ||
| Accounts receivable, net | 25,908 | 17,270 | ||||
| Inventories, net | 12,587 | 13,441 | ||||
| Prepaid expenses and other current assets | 5,292 | 3,845 | ||||
| Total Current Assets | 105,977 | 108,892 | ||||
| Long term marketable securities | 55,009 | 19,816 | ||||
| Property and equipment, net | 3,874 | 2,448 | ||||
| Deferred legal fees | 22,503 | 5,209 | ||||
| Intangible assets, net | 976 | 225 | ||||
| Other non-current assets | 391 | 918 | ||||
| Total Assets | $ | 188,730 | $ | 137,508 | ||
| Accounts payable | $ | 4,314 | $ | 1,863 | ||
| Accrued sales deduction | 26,794 | 8,461 | ||||
| Accrued expenses | 24,813 | 17,026 | ||||
| Deferred licensing revenue | 176 | 143 | ||||
| Total Current Liabilities | 56,097 | 27,493 | ||||
| Deferred licensing revenue, net of current portion | 1,390 | 1,274 | ||||
| Convertible notes, net of discount | 7,189 | 26,947 | ||||
| Other non-current liabilities | 4,325 | 3,876 | ||||
| Derivative liabilities | 854 | 6,564 | ||||
| Total Liabilities | 69,855 | 66,154 | ||||
| Total Stockholders' Equity | 118,875 | 71,354 | ||||
| Total Liabilities & Stockholders' Equity | $ | 188,730 | $ | 137,508 | ||
| Consolidated Statements of Operations | |||||||||||||||||||
| (in thousands, except share and per share data) | |||||||||||||||||||
| Three Months ended | Year ended | ||||||||||||||||||
| 2015 | 2014 | 2015 | 2014 | ||||||||||||||||
| (unaudited) | (unaudited) | ||||||||||||||||||
| Revenue | |||||||||||||||||||
| Net product sales | $ | 42,611 | $ | 30,515 | $ | 143,526 | $ | 89,571 | |||||||||||
| Revenue from royalty agreement | — | — | — | 30,000 | |||||||||||||||
| Licensing revenue | 44 | 286 | 901 | 2,474 | |||||||||||||||
| Total revenue | 42,655 | 30,801 | 144,427 | 122,045 | |||||||||||||||
| Costs and expenses | |||||||||||||||||||
| Cost of product sales | 2,794 | 2,282 | 8,423 | 5,758 | |||||||||||||||
| Research and development | 9,446 | 5,772 | 29,135 | 19,586 | |||||||||||||||
| Selling, general and administrative | 23,566 | 18,018 | 89,204 | 72,471 | |||||||||||||||
| Total costs and expenses | 35,806 | 26,072 | 126,762 | 97,815 | |||||||||||||||
| Operating income | 6,849 | 4,729 | 17,665 | 24,230 | |||||||||||||||
| Other income (expense) | |||||||||||||||||||
| Interest income | 225 | 83 | 643 | 348 | |||||||||||||||
| Interest expense | (225 | ) | (1,189 | ) | (1,229 | ) | (4,963 | ) | |||||||||||
| Changes in fair value of derivative liabilities | 127 | 694 | 193 | 2,809 | |||||||||||||||
| Loss on extinguishment of debt | 62 | — | (2,338 | ) | (2,592 | ) | |||||||||||||
| Other income | 8 | 37 | 38 | 39 | |||||||||||||||
| Total other expense | 197 | (375 | ) | (2,693 | ) | (4,359 | ) | ||||||||||||
| Earnings before income taxes | 7,046 | 4,354 | 14,972 | 19,871 | |||||||||||||||
| Income tax expense | 174 | — | 956 | — | |||||||||||||||
| Net income | $ | 6,872 | $ | 4,354 | $ | 14,016 | $ | 19,871 | |||||||||||
| Income per common share: | |||||||||||||||||||
| Basic | $ | 0.14 | $ | 0.10 | $ | 0.30 | $ | 0.47 | |||||||||||
| Diluted | $ | 0.14 | $ | 0.10 | $ | 0.28 | $ | 0.32 | |||||||||||
| Weighted-average number of common shares: | |||||||||||||||||||
| Basic | 48,891,847 | 42,931,146 | 47,485,258 | 42,260,896 | |||||||||||||||
| Diluted | 49,598,030 | 43,201,227 | 51,160,380 | 50,583,511 | |||||||||||||||
| Summary of Non-GAAP Adjustments | ||||||||||
| (in thousands, except per share data) | ||||||||||
| Adjustment | ||||||||||
| Revenue from | ||||||||||
| GAAP | Royalty Agreement | Non-GAAP | ||||||||
| Year ended | ||||||||||
| Total Revenue | $ | 122,045 | $ | (30,000 | ) | $ | 92,045 | |||
| Operating income | 24,230 | (30,000 | ) | (5,770 | ) | |||||
| Net income (loss) | 19,871 | (30,000 | ) | (10,129 | ) | |||||
| Income (loss) per common share-basic | 0.47 | — | (0.24 | ) | ||||||
| Income (loss) per common share-diluted | 0.32 | — | (0.24 | ) | ||||||
| Weighted-average number of common shares: | ||||||||||
| Basic | 42,260,896 | 42,260,896 | ||||||||
| Diluted | 50,583,511 | 42,260,896 | ||||||||
CONTACTS:Jack A. Khattar , President and CEOGregory S. Patrick , Vice President and CFOSupernus 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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