Supernus Announces Second Quarter 2018 Financial Results and Record Quarterly Revenue
- Total revenue of
$99.5 million , a 31% increase over 2017 - Net product sales of
$97.0 million , a 32% increase over 2017 - Operating earnings of
$35.7 million , a 37% increase over 2017 - Diluted earnings per share (GAAP) of
$0.57 , a 78% increase over 2017 - Completed enrollment in the first SPN-812 Phase III trial (P301), with data expected in the fourth quarter of 2018
Commercial Update
Second quarter 2018 product prescriptions for Trokendi XR® and Oxtellar XR®, as reported by
| Prescriptions | |||
| Q2 2018 | Q2 2017 | Change % | |
| Trokendi XR | 177,052 | 124,089 | 42.7% |
| Oxtellar XR | 37,789 | 34,468 | 9.6% |
| Total | 214,841 | 158,557 | 35.5% |
Source:
Net product sales for the second quarter of 2018 were
| Net Product Sales ($ in millions) | |||||
| Q2 2018 | Q2 2017 | Change % | |||
| Trokendi XR | $76.4 | $56.0 | 36.4% | ||
| Oxtellar XR | $20.6 | $17.3 | 19.1% | ||
| Total | $97.0 | $73.3 | 32.3% | ||
“Solid commercial execution has enabled Supernus to generate another strong quarter of growth, setting a new record for both Trokendi XR and Oxtellar XR quarterly net product sales,” said
SPN-812 – Novel non-stimulant for the treatment of ADHD
- The program consists of four three-arm, placebo-controlled trials: P301 and P302 trials in patients 6-11 years old, and P303 and P304 trials in adolescent patients.
- Enrollment is complete in the P301 trial, with data expected in the fourth quarter of 2018.
- The remaining three trials are at approximately 89% enrollment, with data expected in the first quarter of 2019.
- Roll-over from the four Phase III trials to the open label extension study is approximately 90%.
SPN-810 – Treatment of Impulsive Aggression in patients with ADHD
- Enrollment in the Phase III pediatric trials, P301 and P302, is approximately 91% and 77%, respectively.
- The Company anticipates having data from P301 by the first quarter of 2019 and data from P302 by mid-2019.
- Roll-over from the two Phase III trials to the open label extension study continues at approximately 90%.
- Patient screening has been initiated in the Phase III trial treating adolescents.
Oxtellar XR –Treatment of Bipolar Disorder
- The Company is planning to initiate pivotal Phase III studies for treatment of bipolar disorder in the second half of 2019.
“As we enter the second half of 2018, we remain focused on the successful completion of our clinical programs and look forward to providing top-line data from the first Phase III trial for SPN-812 in the fourth quarter of 2018,” said
Operating Expenses
Research and development expenses in the second quarter of 2018 were
Selling, general and administrative expenses in the second quarter of 2018 were
Operating Earnings and Earnings Per Share
Operating earnings in the second quarter of 2018 were
GAAP net earnings in the second quarter of 2018 were
GAAP diluted earnings per share (EPS) were
Weighted-average diluted common shares outstanding were approximately 54.2 million in the second quarter of 2018, as compared to approximately 53.2 million in the second quarter of 2017.
As of
Financial Guidance
For full year 2018, the Company is updating its prior guidance as set forth below:
- Net product sales in the range of
$385 million to $400 million , compared to the previously expected range of $375 million to $400 million. - Research and development expenses of approximately
$80 million . - Operating earnings in the range of
$130 million to $140 million , compared to the previously expected range of $125 million to $135 million. The Company continues to expect approximately$7 million of licensing and non-cash royalty revenue. - The Company expects an effective tax rate of approximately 23% to 25% for the third and fourth quarters of 2018.
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: 7484048
Conference Call Name: Supernus Pharmaceuticals Second Quarter 2018 Earnings Conference Call
Following the live call, a replay will be available on the Company's website, www.supernus.com, under “Investor Relations”.
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 filings with the
| Supernus Pharmaceuticals, Inc. | ||||||||
| Consolidated Balance Sheets | ||||||||
| (in thousands, except share amounts) | ||||||||
| June 30, | December 31, | |||||||
| 2018 | 2017 | |||||||
| Assets | (unaudited) | |||||||
| Current assets | ||||||||
| Cash and cash equivalents | $ | 35,205 | $ | 100,304 | ||||
| Marketable securities | 139,208 | 39,736 | ||||||
| Accounts receivable, net | 74,842 | 65,586 | ||||||
| Inventories, net | 20,680 | 16,304 | ||||||
| Prepaid expenses and other current assets | 14,581 | 6,521 | ||||||
| Total current assets | 284,516 | 228,451 | ||||||
| Long term marketable securities | 503,312 | 133,638 | ||||||
| Property and equipment, net | 4,897 | 5,124 | ||||||
| Intangible assets, net | 33,794 | 36,019 | ||||||
| Other non-current assets | 752 | 389 | ||||||
| Deferred income taxes | 25,528 | 20,843 | ||||||
| Total assets | $ | 852,799 | $ | 424,464 | ||||
| Liabilities and stockholders' equity | ||||||||
| Current liabilities | ||||||||
| Accounts payable | $ | 2,943 | $ | 6,844 | ||||
| Accrued sales deductions | 70,044 | 68,343 | ||||||
| Accrued expenses | 29,288 | 27,305 | ||||||
| Income taxes payable | — | 15,938 | ||||||
| Non-recourse liability related to sale of future royalties, current portion | 1,659 | 4,283 | ||||||
| Deferred licensing revenue | — | 287 | ||||||
| Total current liabilities | 103,934 | 123,000 | ||||||
| Deferred licensing revenue, net of current portion | — | 1,149 | ||||||
| Convertible notes, net | 321,920 | — | ||||||
| Non-recourse liability related to sale of future royalties, long term | 23,867 | 22,258 | ||||||
| Other non-current liabilities | 12,586 | 10,577 | ||||||
| Total liabilities | 462,307 | 156,984 | ||||||
| Stockholders' equity | ||||||||
| Common stock, $0.001 par value, 130,000,000 shares authorized at | ||||||||
| June 30, 2018 and December 31, 2017; 52,179,334 and 51,314,850 shares issued and outstanding at June 30, 2018 and December 31, 2017, respectively | 52 | 51 | ||||||
| Additional paid-in capital | 361,971 | 294,999 | ||||||
| Accumulated other comprehensive loss, net of tax | (4,119 | ) | (747 | ) | ||||
| Retained earnings (accumulated deficit) | 32,588 | (26,823 | ) | |||||
| Total stockholders' equity | 390,492 | 267,480 | ||||||
| Total liabilities and stockholders' equity | $ | 852,799 | $ | 424,464 | ||||
| Supernus Pharmaceuticals, Inc. | |||||||||||||||
| Consolidated Statements of Earnings | |||||||||||||||
| (in thousands, except share and per share data) | |||||||||||||||
| Three Months ended June 30, | Six Months ended June 30, | ||||||||||||||
| 2018 | 2017 | 2018 | 2017 | ||||||||||||
| (unaudited) | (unaudited) | ||||||||||||||
| Revenue | |||||||||||||||
| Net product sales | $ | 97,030 | $ | 73,328 | $ | 186,150 | $ | 129,697 | |||||||
| Royalty revenue | 1,758 | 1,179 | 3,067 | 2,328 | |||||||||||
| Licensing revenue | 750 | 1,322 | 750 | 1,380 | |||||||||||
| Total revenue | 99,538 | 75,829 | 189,967 | 133,405 | |||||||||||
| Costs and expenses | |||||||||||||||
| Cost of product sales | 3,683 | 3,861 | 6,961 | 6,809 | |||||||||||
| Research and development | 20,038 | 10,823 | 38,946 | 20,425 | |||||||||||
| Selling, general and administrative | 40,097 | 35,078 | 76,946 | 63,316 | |||||||||||
| Total costs and expenses | 63,818 | 49,762 | 122,853 | 90,550 | |||||||||||
| Operating earnings | 35,720 | 26,067 | 67,114 | 42,855 | |||||||||||
| Other income (expense) | |||||||||||||||
| Interest income | 3,664 | 656 | 4,870 | 1,187 | |||||||||||
| Interest expense | (4,324 | ) | (58 | ) | (5,041 | ) | (147 | ) | |||||||
| Interest expense-nonrecourse liability related to sale of future royalties |
(1,204 | ) | (160 | ) | (1,905 | ) | (1,119 | ) | |||||||
| Changes in fair value of derivative liabilities | — | 23 | — | 76 | |||||||||||
| Loss on extinguishment of debt | — | (103 | ) | — | (204 | ) | |||||||||
| Total other income (expense) | (1,864 | ) | 358 | (2,076 | ) | (207 | ) | ||||||||
| Earnings before income taxes | 33,856 | 26,425 | 65,038 | 42,648 | |||||||||||
| Income tax expense | 3,119 | 9,057 | 7,949 | 14,983 | |||||||||||
| Net earnings | $ | 30,737 | $ | 17,368 | $ | 57,089 | $ | 27,665 | |||||||
| Earnings per share: | |||||||||||||||
| Basic | $ | 0.59 | $ | 0.34 | $ | 1.10 | $ | 0.55 | |||||||
| Diluted | $ | 0.57 | $ | 0.32 | $ | 1.06 | $ | 0.52 | |||||||
| Weighted-average number of common shares outstanding: | |||||||||||||||
| Basic | 51,919,894 | 50,530,968 | 51,729,243 | 50,345,830 | |||||||||||
| Diluted | 54,203,308 | 53,223,714 | 54,021,941 | 53,026,323 | |||||||||||
CONTACTS:
Tel: (301) 838-2591
or
INVESTOR CONTACT:
Westwicke Partners
Office: (443) 213-0505
Mobile: (443) 377-4767
Email: peter.vozzo@westwicke.com
Source: Supernus Pharmaceuticals, Inc.