Supernus Announces First Quarter 2016 Financial Results
- First quarter 2016 product prescriptions totaled 114,773, representing a 49.7% increase over the first quarter of 2015.
- Net product sales for first quarter 2016 were
$43.0 million , a 53.1% increase over the first quarter of 2015. - Operating income for first quarter 2016 was
$5.3 million , a 55.0% increase over the first quarter of 2015. - Diluted earnings per share in the first quarter were
$0.08 compared to$0.02 in the same period last year. - The Company remains on track to have data available from the Phase III program for SPN-810, for the treatment of Impulsive Aggression in ADHD, by mid-2017 and from the Phase IIb program for SPN-812, for the treatment of ADHD, by early 2017.
Commercial Update
First quarter 2016 product prescriptions for Trokendi XR® and Oxtellar XR®, as reported by IMS, totaled 114,773, a 49.7% increase over the first quarter of 2015.
| Prescriptions | ||||||||
| Q1 2016 | Q1 2015 | Change % | ||||||
| Trokendi XR | 85,987 | 55,227 | 55.7 | % | ||||
| Oxtellar XR | 28,786 | 21,463 | 34.1 | % | ||||
| Total | 114,773 | 76,690 | 49.7 | % | ||||
| Source Data: Product prescriptions as reported by IMS | ||||||||
Total revenue for the first quarter of 2016 was
| Net Product Sales ($mil.) | ||||||||||||
| Q1 2016 | Q1 2015 | Change % | ||||||||||
| Trokendi XR | $ | 32.3 | $ | 20.9 | 54.5 | % | ||||||
| Oxtellar XR | $ | 10.7 | $ | 7.2 | 49.3 | % | ||||||
| Total | $ | 43.0 | $ | 28.1 | 53.1 | % | ||||||
Consistent with industry trends and the Company's experience in the first quarter last year, product prescriptions and net product sales for Trokendi XR and Oxtellar XR were unfavorably impacted by the reset of insurance coverage at the beginning of the year, with high deductible and high co-pay programs. Additionally, changes in wholesaler inventory levels and ordering patterns during the first quarter of 2016 had the effect of reducing net product sales by approximately
"Our business continues to post strong growth compared to last year. Total first quarter IMS
prescriptions, and net product sales grew by 50% or more compared to the same period last year. We continue to build on the momentum we finished with last year promoting the benefits of our products to patients with epilepsy," said
Regarding our supplemental new drug application requesting approval to expand the Trokendi XR label to include treatment of migraine in adults, we are ready to launch the new migraine indication once we receive full approval from the
Progress of Product Pipeline
Enrollment continues for both Phase III trials for SPN-810, which is currently in development for Impulsive Aggression in patients who have ADHD, and for the Phase IIb trial for SPN-812, currently in development for ADHD. The Company continues to expect Phase III data for SPN-810 to be available by mid 2017, and data from the SPN-812 Phase IIb trial to be available by early 2017.
"In addition to our recent findings on the favorable emerging clinical profile of SPN-812 as it relates to adverse events, we completed the evaluation of the cardiac effects portion of the single ascending and multiple ascending dose study. We are pleased to report that there was no clinically significant change in QT interval and other ECG parameters. We believe these additional safety data in adult healthy volunteers, which show a lack of cardiac effects, are very encouraging and further strengthen the differentiation of SPN-812," said
Collaboration Update
Shire recently announced positive results
of
Operating Expenses
Research and development expenses in the first quarter of 2016 were
Selling, general and administrative expenses in the first quarter of 2016 were
Operating Income and Earnings Per Share
Operating income in the first quarter of 2016 was
Diluted earnings per share were
Weighted-average diluted common shares outstanding were approximately 51.2 million in the first quarter of 2016, as compared to approximately 44.9 million in the same period the prior year.
Capital Resources
As of
Financial Guidance
For full year 2016, the Company reiterates its expectation that net product sales 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: | 94042155 |
| 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 | $ | 45,257 | $ | 62,190 | ||
| Accounts receivable, net | 30,651 | 25,908 | ||||
| Inventories, net | 13,044 | 12,587 | ||||
| Prepaid expenses and other current assets | 5,003 | 5,261 | ||||
| Total Current Assets | 93,955 | 105,946 | ||||
| Long term marketable securities | 68,790 | 55,009 | ||||
| Property and equipment, net | 3,866 | 3,874 | ||||
| Deferred legal fees | 11,444 | 22,503 | ||||
| Intangible assets, net | 16,108 | 976 | ||||
| Other non-current assets | 311 | 318 | ||||
| Total Assets | $ | 194,474 | $ | 188,626 | ||
| Accounts payable | $ | 2,646 | $ | 4,314 | ||
| Accrued sales deduction | 28,697 | 26,794 | ||||
| Accrued expenses | 22,573 | 24,813 | ||||
| Deferred licensing revenue | 208 | 176 | ||||
| Total Current Liabilities | 54,124 | 56,097 | ||||
| Deferred licensing revenue, net of current portion | 1,658 | 1,390 | ||||
| Convertible notes, net of discount | 5,627 | 7,085 | ||||
| Other non-current liabilities | 4,391 | 4,325 | ||||
| Derivative liabilities | 535 | 854 | ||||
| Total Liabilities | 66,335 | 69,751 | ||||
| Total Stockholders' Equity | 128,139 | 118,875 | ||||
| Total Liabilities & Stockholders' Equity | $ | 194,474 | $ | 188,626 | ||
| Consolidated Statements of Operations | |||||||||
| (in thousands, except share and per share data) | |||||||||
| Three Months ended | |||||||||
| 2016 | 2015 | ||||||||
| (unaudited) | |||||||||
| Revenue | |||||||||
| Net product sales | $ | 43,025 | $ | 28,097 | |||||
| Licensing revenue | 50 | 36 | |||||||
| Total revenue | 43,075 | 28,133 | |||||||
| Costs and expenses | |||||||||
| Cost of product sales | 2,035 | 1,618 | |||||||
| Research and development | 10,562 | 3,683 | |||||||
| Selling, general and administrative | 25,160 | 19,402 | |||||||
| Total costs and expenses | 37,757 | 24,703 | |||||||
| Operating income | 5,318 | 3,430 | |||||||
| Other income (expense) | |||||||||
| Interest income | 331 | 113 | |||||||
| Interest expense | (179 | ) | (381 | ) | |||||
| Changes in fair value of derivative liabilities | 101 | (49 | ) | ||||||
| Loss on extinguishment of debt | (382 | ) | (2,134 | ) | |||||
| Other income | (4 | ) | - | ||||||
| Total other expense | (133 | ) | (2,451 | ) | |||||
| Earnings before income taxes | 5,185 | 979 | |||||||
| Income tax expense | 198 | 62 | |||||||
| Net income | $ | 4,987 | $ | 917 | |||||
| Income per common share: | |||||||||
| Basic | $ | 0.10 | $ | 0.02 | |||||
| Diluted | $ | 0.08 | $ | 0.02 | |||||
| Weighted-average number of common shares: | |||||||||
| Basic | 49,240,099 | 44,563,299 | |||||||
| Diluted | 51,152,072 | 44,901,298 | |||||||
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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