Supernus Announces Second Quarter 2019 Financial Results
- Total revenue of
$104.7 million, a 5.2% increase over 2018
- Net product sales of
$102.4 million, a 5.5% increase over 2018
- Operating earnings of
$42.6 million, a 19.3% increase over 2018
- Submission of New Drug Application for SPN-812 on track for the second half of 2019
- Revising full year 2019 net product sales guidance range to
$400 million - $410 millionand full year 2019 operating earnings range to $150 million - $160 million
Second quarter 2019 product prescriptions for Trokendi XR® and Oxtellar XR®, as reported by
|Q2 2019||Q2 2018||Change %|
Net product sales for the second quarter of 2019 were
|Net Product Sales
($ in millions)
|Q2 2019||Q2 2018||Change %|
“Prescription growth for Trokendi XR improved by 4.8% in the second quarter of 2019 as compared to the first quarter of 2019, but not to the degree we had expected,” said
SPN-812 - Novel non-stimulant for the treatment of ADHD
– The Company concluded its pre-New Drug Application (NDA) clinical meeting with the U.S. Food and Drug Administration (
– The Company has advanced manufacture of SPN-812 to support the NDA submission and in preparation of commercial launch.
– A Phase III program in adult patients is anticipated to start in the fourth quarter of 2019.
SPN-810 - Novel treatment of Impulsive Aggression in patients with ADHD
– Enrollment in the Phase III P301 trial is complete, with data expected in the fourth quarter of 2019.
– Enrollment in the Phase III P302 trial continues, with data now expected in the first quarter of 2020.
– The Company continues to expect to submit an NDA for SPN-810 in the second half of 2020, and to launch SPN-810, pending
– Enrollment in the open label extension (OLE) study continues at 90% or higher. On average, a patient in the OLE study remains on SPN-810 treatment for approximately 10.7 months, which the Company believes is an encouraging sign of the tolerability and efficacy of SPN-810.
– Patient dosing continues in the Phase III trial (P503) in adolescent patients.
SPN-604 - Novel treatment of bipolar disorder
– The Company remains on track to start a pivotal Phase III program for the treatment of bipolar disorder in the fourth quarter of 2019.
Research and development (R&D) expenses in the second quarter of 2019 were
Selling, general and administrative expenses in the second quarter of 2019 were
Operating Earnings and Earnings Per Share
Operating earnings in the second quarter of 2019 were
Net earnings (GAAP) in the second quarter of 2019 were
Weighted-average diluted common shares outstanding were approximately 53.9 million in the second quarter of 2019, as compared to approximately 54.2 million in the prior year period.
Balance Sheet Highlights
As of June 30, 2019, the Company had
The Company is revising its full year 2019 guidance for net product sales and operating earnings, and reaffirming expectations for R&D expenses and the effective tax rate as set forth below:
– Net product sales in the range of
– R&D expenses in the range of
– Operating earnings in the range of
– Effective tax rate of approximately 23% to 25%.
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 Call Name:||Supernus Pharmaceuticals Second Quarter 2019 Earnings Conference Call|
Following the live call, a replay will be available on the Company's website, www.supernus.com, under “Investor Relations”.
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
Condensed Consolidated Balance Sheets
(in thousands, except share amounts)
|June 30,||December 31,|
|Cash and cash equivalents||$||87,344||$||192,248|
|Accounts receivable, net||84,564||102,922|
|Prepaid expenses and other current assets||21,757||8,888|
|Total current assets||390,911||493,487|
|Long term marketable securities||593,754||418,798|
|Property and equipment, net||4,028||4,095|
|Intangible assets, net||28,787||31,368|
|Deferred income taxes||25,975||29,683|
|Liabilities and stockholders’ equity|
|Accrued product returns and rebates||95,934||107,063|
|Accrued expenses and other current liabilities||38,614||36,535|
|Income taxes payable||2,674||12,377|
|Non-recourse liability related to sale of future royalties, current portion||2,668||2,183|
|Total current liabilities||143,971||161,353|
|Convertible notes, net||337,210||329,462|
|Non-recourse liability related to sale of future royalties, long term||21,100||22,575|
|Lease liabilities, long term||27,535||—|
|Common stock, $0.001 par value, 130,000,000 shares authorized 52,449,036 and 52,316,583 shares
issued and outstanding as of June 30, 2019 and December 31, 2018, respectively
|Additional paid-in capital||379,369||369,637|
|Accumulated other comprehensive earnings (loss), net of tax||5,924||(3,158||)|
|Total stockholders’ equity||522,904||453,023|
|Total liabilities and stockholders’ equity||$||1,063,675||$||977,811|
Condensed Consolidated Statements of Earnings
(in thousands, except share and per share data)
|Three Months ended June 30,||Six Months ended June 30,|
|Net product sales||$||102,358||$||97,030||$||185,457||$||186,150|
|Costs and expenses|
|Cost of product sales||4,044||3,683||7,728||6,961|
|Research and development||16,970||20,038||32,364||38,946|
|Selling, general and administrative||41,083||40,097||82,051||76,946|
|Total costs and expenses||62,097||63,818||122,143||122,853|
|Other income (expenses), net||148||(1,864||)||(1,041||)||(2,076||)|
|Earnings before income taxes||42,746||33,856||66,985||65,038|
|Income tax expense||10,019||3,119||15,918||7,949|
|Earnings per share|
|Weighted-average shares outstanding|
Tel: (301) 838-2591
Office: (443) 213-0505
Mobile: (443) 377-4767
Source: Supernus Pharmaceuticals, Inc.