Supernus Announces First Quarter 2019 Financial Results
- Total revenue of
$85.5 millionand net product sales of $83.1 million. Net product sales compare to $89.1 millionin 2018 and were adversely impacted by approximately $10 millionin channel inventory reduction in the first quarter, coupled with seasonal insurance plan dynamics
- Prescription growth of 11% in 2019, for both Trokendi XR and Oxtellar XR, as compared to 2018
- Operating earnings of
$25.4 millioncompared to $31.4 millionin 2018. Operating earnings in 2019 were adversely affected by approximately $9.5 million, due to channel inventory reduction.
- In addition to channel inventory reduction, increase in effective tax rate to 24.3% in 1Q 2019, compared to 15.5% in 1Q 2018, which adversely impacted diluted earnings per share in 2019,
$0.34, as compared to $0.49in 2018.
- Financial guidance reaffirmed
First quarter 2019 product prescriptions for Trokendi XR® and Oxtellar XR®, as reported by
|Q1 2019||Q1 2018||Change %|
In the fourth quarter of 2018, wholesalers, distributors, and pharmacies increased their inventory holdings as compared to the prevailing inventory levels in the third quarter of 2018. As previously disclosed, the Company estimated that this caused net product sales to be approximately
This process was effectively reversed in the first quarter of 2019, with net product sales decreasing in the first quarter of 2019 by an estimated
In addition, net product sales were impacted by the growing prevalence of high deductible patient plans, their seasonal effect on first quarter prescription trends, and the seasonal increase in our use of copay assistance. Consequently, gross to net deductions were higher by approximately
Net product sales decreased by
|Net Product Sales
($ in millions)
|Q1 2019||Q1 2018||Change %|
During its Investor Day held on
SPN-812 – Novel non-stimulant for the treatment of ADHD
March 2019, the Company announced data from the fourth and final Phase III study for SPN-812 (P304) that confirm positive results from the previous three Phase III studies on SPN-812, announced in December 2018.
- The Company continues to expect to submit a New Drug Application (NDA) for SPN-812 in the second half of 2019, and to launch it, pending U.S. Food and Drug Administration (
FDA) approval, in the second half of 2020.
- A Phase III program in adult patients is anticipated to start in the second half of 2019.
SPN-810 – Novel treatment of Impulsive Aggression in patients with ADHD
- Enrollment in the Phase III trials (P301 and P302) continues with data from both trials expected in the second half of 2019.
- The Company continues to expect to submit an NDA for SPN-810 in the second half of 2020, and to launch it, pending
FDAapproval, in the second half of 2021.
- 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 10.5 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 expects to start a pivotal Phase III program for the treatment of bipolar disorder in the fourth quarter of 2019.
Research and development expenses in the first quarter of 2019 were
Selling, general and administrative expenses in the first quarter of 2019 were
Operating Earnings and Earnings Per Share
Operating earnings in the first quarter of 2019 were
Net earnings (GAAP) in the first quarter of 2019 were
Weighted-average diluted common shares outstanding were approximately 54.0 million in the first quarter of 2019, as compared to approximately 53.8 million in the prior year period.
“Our financial results for the first quarter were adversely impacted by several factors, converging all at once: the fourth quarter 2018 inventory buildup impacting shipments in first quarter 2019: first quarter seasonal insurance plan dynamics putting pressure on prescription growth coupled with increased gross-to-net deductions through our copay assistance; and the increase in the effective tax rate compared to same period in 2018,” said
Balance Sheet Highlights
For full year 2019, the Company reiterates its prior guidance for net product sales, research and development expenses, operating earnings, and effective tax rate as set forth below:
- Net product sales in the range of
$435 million to $455 million
- Research and development expenses in the range of
$70 million to $80 million
- Operating earnings in the range of
$160 million to $180 million
- 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 First 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
|Supernus Pharmaceuticals, Inc.|
|Condensed Consolidated Balance Sheets|
|(in thousands, except share amounts)|
|March 31,||December 31,|
|Cash and cash equivalents||$||122,778||$||192,248|
|Accounts receivable, net||79,950||102,922|
|Prepaid expenses and other current assets||20,556||8,888|
|Total current assets||419,967||493,487|
|Long term marketable securities||522,551||418,798|
|Property and equipment, net||4,226||4,095|
|Intangible assets, net||30,063||31,368|
|Deferred income taxes||27,967||29,683|
|Liabilities and stockholders' equity|
|Accrued product returns and rebates||88,200||107,063|
|Accrued expenses and other current liabilities||36,607||36,535|
|Income taxes payable||17,233||12,377|
|Non-recourse liability related to sale of future royalties, current portion||2,426||2,183|
|Total current liabilities||151,706||161,353|
|Convertible notes, net||333,310||329,462|
|Non-recourse liability related to sale of future royalties, long term||21,957||22,575|
|Lease liabilities, long term||27,824||—|
|Other non-current liabilities||10,633||11,398|
|Common stock, $0.001 par value, 130,000,000 shares authorized|
|52,374,248 and 52,316,583 shares issued and outstanding as of March 31, 2019 and December 31, 2018, respectively||52||52|
|Additional paid-in capital||373,707||369,637|
|Accumulated other comprehensive earnings (loss), net of tax||1,427||(3,158||)|
|Total stockholders' equity||480,018||453,023|
|Total liabilities and stockholders' equity||$||1,025,448||$||977,811|
|Supernus Pharmaceuticals, Inc.|
|Condensed Consolidated Statements of Earnings|
|(in thousands, except share and per share data)|
|Three Months ended March 31,|
|Net product sales||$||83,099||$||89,120|
|Costs and expenses|
|Cost of product sales||3,684||3,278|
|Research and development||15,394||18,908|
|Selling, general and administrative||40,968||36,849|
|Total costs and expenses||60,046||59,035|
|Other expenses, net||(1,189||)||(212||)|
|Earnings before income taxes||24,239||31,182|
|Income tax expense||5,899||4,830|
|Earnings per share|
|Weighted-average shares outstanding|
Tel: (301) 838-2591
Office: (443) 213-0505
Mobile: (443) 377-4767
Source: Supernus Pharmaceuticals, Inc.