Supernus Announces Second Quarter 2016 Financial Results
- Second quarter 2016 product prescriptions totaled 123,758, a 38.9% increase over the second quarter of 2015.
- Net product sales for second quarter 2016 were
$50.3 million , a 46.9% increase over the second quarter of 2015. - Operating income for second quarter 2016 was
$10.4 million compared to$3.1 million in the second quarter of 2015.
- Diluted earnings per share in the second quarter were
$0.18 compared to$0.03 in the same period last year. - Enrollment completed in SPN-812 Phase IIb trial. Enrollment for SPN-810 Phase III trials expected to continue into 2017.
Commercial Update
Second quarter 2016 product prescriptions for Trokendi XR® and Oxtellar XR®, as reported by IMS, totaled 123,758, a 38.9% increase over the second quarter of 2015.
| Prescriptions | ||||||||
| Q2 2016 | Q1 2015 | Change % | ||||||
| Trokendi XR | 93,094 | 65,552 | 42.0 | % | ||||
| Oxtellar XR | 30,664 | 23,534 | 30.3 | % | ||||
| Total | 123,758 | 89,086 | 38.9 | % | ||||
| Source: IMS | ||||||||
Total revenue for the second quarter of 2016 was
| Net Product Sales ($mil.) | ||||||||||||
| Q2 2016 | Q2 2015 | Change % | ||||||||||
| Trokendi XR | $ | 37.6 | $ | 26.3 | 43.3 | % | ||||||
| Oxtellar XR | $ | 12.7 | $ | 8.0 | 58.7 | % | ||||||
| Total | $ | 50.3 | $ | 34.3 | 46.9 | % | ||||||
"We are pleased with the growth in prescriptions and net product sales in the second quarter and through the first half of 2016. For the first six months of 2016, net product sales increased approximately 50%, as compared to the same period last year," said
In
Progress of Product Pipeline
Enrollment continues for both Phase III trials for SPN-810, which is currently in development for Impulsive Aggression in patients aged 6 to 12 years who have ADHD. The pace of enrollment is slower than anticipated due to challenges such as those experienced by caregivers in recording patient information on the new electronic diary, and lack of compliance during the screening period regarding ‘washing out' of current medications. As a consequence, we have instituted a number of measures to improve patient enrollment and retention. These include lengthening the screening period to provide increased education for site coordinators and caregivers on the electronic diary and to make it easier for caregivers and patients to comply with the trial protocol. Although the pace of recruitment has picked up recently for both Phase III trials, it is likely that enrollment will continue into 2017. The Company continues to expect to launch SPN-810 in 2019. During the third quarter of 2016, patients began enrolling into the open-label extension portion of the Phase III study.
Regarding SPN-812, currently in development for patients aged 6 to 12 years with ADHD, the Phase IIb trial is now fully recruited. The final patient visit was completed during the third quarter of 2016. Eligible patients are now entering the open label extension portion of the study. The Company continues to expect data from the SPN-812 Phase IIb trial to be available by early 2017.
"With the SPN-812 Phase IIb trial fully enrolled, we have reached another important clinical milestone as we continue to advance SPN-812 into late-stage development," said
Operating Expenses
Research and development expenses in the second quarter of 2016 were
Selling, general and administrative expenses in the second quarter of 2016 were
Operating Income and Earnings Per Share
Operating income in the second quarter of 2016 was
Diluted earnings per share were
Weighted-average diluted common shares outstanding were approximately 51.7 million in the second quarter of 2016, as compared to approximately 52.3 million in the same period last year.
Capital Resources
As of
Financial Guidance
For full year 2016, the Company is reiterating guidance for net product sales and adjusting guidance for R&D expenses and operating income as set forth below:
- Net product sales will remain in the range of
$200 million to$210 million . - R&D expenses in the range of
$50 million to$55 million , compared to the previously expected range of$55 million to$65 million . - Operating income in the range of
$32 million to$37 million , compared to the previously expected range of$28 million to$35 million .
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: | 50720151 | |
| 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 | $ | 60,214 | $ | 62,190 | ||
| Accounts receivable, net | 34,281 | 25,908 | ||||
| Inventories, net | 16,373 | 12,587 | ||||
| Prepaid expenses and other current assets | 3,272 | 5,261 | ||||
| Total Current Assets | 114,140 | 105,946 | ||||
| Long term marketable securities | 67,809 | 55,009 | ||||
| Property and equipment, net | 4,193 | 3,874 | ||||
| Deferred legal fees | 16,901 | 22,503 | ||||
| Intangible assets, net | 15,270 | 976 | ||||
| Other non-current assets | 320 | 318 | ||||
| Total Assets | $ | 218,633 | $ | 188,626 | ||
| Accounts payable | $ | 2,243 | $ | 4,314 | ||
| Accrued sales deductions | 35,019 | 26,794 | ||||
| Accrued expenses | 28,102 | 24,813 | ||||
| Deferred licensing revenue | 208 | 176 | ||||
| Total Current Liabilities | 65,572 | 56,097 | ||||
| Deferred licensing revenue, net of current portion | 1,606 | 1,390 | ||||
| Convertible notes, net of discount | 5,699 | 7,085 | ||||
| Other non-current liabilities | 4,322 | 4,325 | ||||
| Derivative liabilities | 412 | 854 | ||||
| Total Liabilities | 77,611 | 69,751 | ||||
| Total Stockholders' Equity | 141,022 | 118,875 | ||||
| Total Liabilities & Stockholders' Equity | $ | 218,633 | $ | 188,626 | ||
| Consolidated Statements of Operations | |||||||||||||||||||
| (in thousands, except share and per share data) | |||||||||||||||||||
| Three Months ended | Six Months ended | ||||||||||||||||||
| 2016 | 2015 | 2016 | 2015 | ||||||||||||||||
| (unaudited) | (unaudited) | ||||||||||||||||||
| Revenue | |||||||||||||||||||
| Net product sales | $ | 50,335 | $ | 34,266 | $ | 93,360 | $ | 62,363 | |||||||||||
| Licensing revenue | 86 | 786 | 135 | 822 | |||||||||||||||
| Total revenue | 50,421 | 35,052 | 93,495 | 63,185 | |||||||||||||||
| Costs and expenses | |||||||||||||||||||
| Cost of product sales | 2,751 | 1,762 | 4,786 | 3,380 | |||||||||||||||
| Research and development | 11,109 | 6,878 | 21,671 | 10,561 | |||||||||||||||
| Selling, general and administrative | 26,121 | 23,336 | 51,281 | 42,737 | |||||||||||||||
| Total costs and expenses | 39,981 | 31,976 | 77,738 | 56,678 | |||||||||||||||
| Operating income | 10,440 | 3,076 | 15,757 | 6,507 | |||||||||||||||
| Other income (expense) | |||||||||||||||||||
| Interest income | 363 | 137 | 694 | 250 | |||||||||||||||
| Interest expense | (196 | ) | (331 | ) | (375 | ) | (712 | ) | |||||||||||
| Changes in fair value of derivative liabilities | 123 | 1 | 224 | (48 | ) | ||||||||||||||
| Loss on extinguishment of debt | — | (241 | ) | (382 | ) | (2,375 | ) | ||||||||||||
| Other income (expense) | 2 | 25 | (1 | ) | 25 | ||||||||||||||
| Total other income (expense) | 292 | (409 | ) | 160 | (2,860 | ) | |||||||||||||
| Earnings before income taxes | 10,732 | 2,667 | 15,917 | 3,647 | |||||||||||||||
| Income tax expense | 714 | 662 | 912 | 724 | |||||||||||||||
| Net income | $ | 10,018 | $ | 2,005 | $ | 15,005 | $ | 2,923 | |||||||||||
| Income per common share: | |||||||||||||||||||
| Basic | $ | 0.20 | $ | 0.04 | $ | 0.30 | $ | 0.06 | |||||||||||
| Diluted | $ | 0.18 | $ | 0.03 | $ | 0.28 | $ | 0.06 | |||||||||||
| Weighted-average number of common shares: | |||||||||||||||||||
| Basic | 49,427,825 | 47,911,932 | 49,333,962 | 46,246,866 | |||||||||||||||
| Diluted | 51,745,342 | 52,273,549 | 51,484,686 | 47,687,992 | |||||||||||||||
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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