Supernus Announces Record Second Quarter 2017 Financial Results
- Second quarter net product sales were
$73.3 million , a 46% increase over 2016. - Strong acceleration in Trokendi XR prescription growth following April launch in migraine prophylaxis in adults and adolescents.
- Second quarter operating income was
$26.1 million , a 124% increase over 2016. - Raising full year 2017 financial guidance for net product sales by
$15 million and operating income by$7 million . - Phase III trials for SPN-812 to start second half 2017, following recent end-of-Phase II meeting with
FDA .
Commercial Update
Second quarter 2017 product prescriptions for Trokendi XR® and Oxtellar XR®, as reported by IMS, totaled 158,752, a 28.1% increase over the second quarter of 2016.
| Prescriptions | ||||
| Q2 2017 | Q2 2016 | Change % | ||
| Trokendi XR | 124,229 | 93,223 | 33.3% | |
| Oxtellar XR | 34,523 | 30,726 | 12.4% | |
| Total | 158,752 | 123,949 | 28.1% | |
Source: IMS
Net product sales for the second quarter of 2017 were
| Net Product Sales ($mil.) | ||||||
| Q2 2017 | Q2 2016 | Change % | ||||
| Trokendi XR | 48.9% | |||||
| Oxtellar XR | 36.2% | |||||
| Total | 45.7% | |||||
Trokendi XR Migraine Launch
In
For the second quarter of 2017, total prescriptions for Trokendi XR increased by 22.2% from the first quarter of 2017. This compares to an increase of 8.1% in the second quarter of 2016 over the first quarter of 2016. Similarly, for the same sequential quarter-to-quarter time periods, new prescriptions for Trokendi XR increased by 31.2% in 2017, compared to 5.8% in 2016.
| Prescription Growth Compared to Q1 | |||||||||
| Q2 2017 | Q2 2016 | ||||||||
| Prescriptions | Change % | Prescriptions | Change % | ||||||
| Trokendi XR - Total | 22,534 | 22.2% | 6,996 | 8.1% | |||||
| Trokendi XR - New | 14,594 | 31.2% | 2,352 | 5.8% | |||||
Source: IMS
"We are very pleased with the launch of Trokendi XR in migraine prophylaxis, which we believe is a reflection of the positive feedback we have recently received from physicians because of the clinical benefits Trokendi XR offers to patients," said
"As a result of the continued strong launch and the outstanding
performance of our sales organization, we plan to expand our salesforce by approximately 40 sales representatives by the fourth quarter of 2017. The expanded salesforce will consist of more than 200 sales representatives in total and will provide additional support to both Trokendi XR and Oxtellar XR," said
Progress of Product Pipeline
Enrollment continues in both Phase III trials for SPN-810, currently in development for Impulsive Aggression in patients aged 6 to 12 years who have ADHD. Enrollment into the Phase III trials has shown steady progress as a result of the protocol revisions and programs implemented to improve patient retention and drive patient enrollment. Enrollment is at approximately 60% and 50% of target patient enrollment in the first and second trials, respectively. The Company
expects enrollment to continue through mid-2018. The Company is also discussing with the
Regarding SPN-812, the Company continues to plan to initiate Phase III clinical testing during the second half of 2017 following a meeting with the
The Oxtellar XR investigator-sponsored trial in bipolar disorder is also on track to start in the third quarter of 2017.
Operating Expenses
Research and development expenses in the second quarter of 2017 were
Selling, general and administrative expenses in the second quarter of 2017 were
Operating Income and Earnings Per Share
Operating income in the second quarter of 2017 was
Diluted
earnings per share for the second quarter of 2017 were
Weighted-average diluted common shares outstanding were approximately 53.2 million in the second quarter of 2017, as compared to approximately 51.7 million in the same period the prior year.
Capital Resources
As of
Financial Guidance
For full year 2017, the Company is raising its expectations for both net product sales and operating income, and reiterating its expectation for research and development expense as set forth below:
- Net product sales in the range of
$280 million to$290 million , or$15 million higher than the previously expected range of$265 million to$275 million . - Research and development expense of approximately
$55 million . - Operating income in the range of
$82 million to$87 million , or$7 million higher than the previously expected range of$75 million to$80 million . The Company continues to expect that full year 2017 operating income will include approximately$5 million of non-cash royalty revenue.
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: | 55235874 | |
| Conference Call Name: | Supernus Pharmaceuticals Second Quarter 2017 Earnings Conference Call | |
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
| Consolidated Balance Sheets | |||||||
| (in thousands) | |||||||
| (unaudited) | |||||||
| Cash, cash equivalents and marketable securities | $ | 92,966 | $ | 90,121 | |||
| Accounts receivable, net | 51,157 | 41,527 | |||||
| Inventories, net | 16,623 | 16,801 | |||||
| Prepaid expenses and other current assets | 4,746 | 2,955 | |||||
| Total current assets | 165,492 | 151,404 | |||||
| Long term marketable securities | 104,632 | 75,410 | |||||
| Property and equipment, net | 4,572 | 4,344 | |||||
| Deferred legal fees | 11,887 | 19,860 | |||||
| Intangible assets, net | 28,989 | 16,490 | |||||
| Other non-current assets | 349 | 331 | |||||
| Deferred income tax | 30,449 | 41,729 | |||||
| Total assets | $ | 346,370 | $ | 309,568 | |||
| Accounts payable | $ | 7,577 | $ | 8,055 | |||
| Accrued sales deductions | 47,621 | 41,943 | |||||
| Accrued expenses | 23,434 | 27,427 | |||||
| Accrued income taxes payable | 1,608 | 7 | |||||
| Non-recourse liability related to sale of future royalties, current portion | 4,997 | 3,101 | |||||
| Deferred licensing revenue | 287 | 209 | |||||
| Total current liabilities | 85,524 | 80,742 | |||||
| Deferred licensing revenue, net of current portion | 1,293 | 1,501 | |||||
| Convertible notes, net | 1,472 | 4,165 | |||||
| Non-recourse liability related to sale of future royalties, long term | 24,184 | 27,289 | |||||
| Other non-current liabilities | 4,500 | 4,002 | |||||
| Derivative liabilities | - | 114 | |||||
| Total liabilities | 116,973 | 117,813 | |||||
| Total stockholders' equity | 229,397 | 191,755 | |||||
| Total liabilities and stockholders' equity | $ | 346,370 | $ | 309,568 | |||
| Consolidated Statements of Operations | |||||||||||||||
| (in thousands, except share and per share data) | |||||||||||||||
| Three Months ended | Six Months ended | ||||||||||||||
| 2017 | 2016 | 2017 | 2016 | ||||||||||||
| (unaudited) | (unaudited) | ||||||||||||||
| Revenue | |||||||||||||||
| Net product sales | $ | 73,328 | $ | 50,335 | $ | 129,697 | $ | 93,360 | |||||||
| Royalty revenue | 1,179 | 1,205 | 2,328 | 2,324 | |||||||||||
| Licensing revenue | 1,322 | 86 | 1,380 | 135 | |||||||||||
| Total revenue | 75,829 | 51,626 | 133,405 | 95,819 | |||||||||||
| Costs and expenses | |||||||||||||||
| Cost of product sales | 3,861 | 2,751 | 6,809 | 4,786 | |||||||||||
| Research and development | 10,823 | 11,109 | 20,425 | 21,671 | |||||||||||
| Selling, general and administrative | 35,078 | 26,121 | 63,316 | 51,281 | |||||||||||
| Total costs and expenses | 49,762 | 39,981 | 90,550 | 77,738 | |||||||||||
| Operating income | 26,067 | 11,645 | 42,855 | 18,081 | |||||||||||
| Other income (expense) | |||||||||||||||
| Interest income | 656 | 365 | 1,187 | 693 | |||||||||||
| Interest expense | (58 | ) | (196 | ) | (147 | ) | (375 | ) | |||||||
| Interest expense-nonrecourse liability related to sale of future royalties | (160 | ) | (1,281 | ) | (1,119 | ) | (2,560 | ) | |||||||
| Changes in fair value of derivative liabilities | 23 | 123 | 76 | 224 | |||||||||||
| Loss on extinguishment of debt | (103 | ) | - | (204 | ) | (382 | ) | ||||||||
| Total other income (expense) | 358 | (989 | ) | (207 | ) | (2,400 | ) | ||||||||
| Earnings before income taxes | 26,425 | 10,656 | 42,648 | 15,681 | |||||||||||
| Income tax expense | 9,057 | 405 | 14,983 | 605 | |||||||||||
| Net income | $ | 17,368 | $ | 10,251 | $ | 27,665 | $ | 15,076 | |||||||
| Income per common share: | |||||||||||||||
| Basic | $ | 0.34 | $ | 0.21 | $ | 0.55 | $ | 0.31 | |||||||
| Diluted | $ | 0.32 | $ | 0.18 | $ | 0.52 | $ | 0.28 | |||||||
| Weighted-average number of common shares: | |||||||||||||||
| Basic | 50,530,968 | 49,427,825 | 50,345,830 | 49,333,962 | |||||||||||
| Diluted | 53,223,714 | 51,745,342 | 53,026,323 | 51,484,686 | |||||||||||
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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