Supernus Announces Record Full Year 2018 Financial Results
- Fourth quarter 2018 total revenue of
$115.9 million, a 31% increase over 2017, and fourth quarter 2018 net product sales of $113.5 million, a 32% increase over 2017.
- Fourth quarter 2018 operating earnings of
$39.9 million, a 16% increase over 2017.
- Full year 2018 total revenue of
$408.9 million, a 35% increase over 2017. Full year 2018 net product sales of $399.9 million, a 36% increase over 2017.
- Full year 2018 operating earnings of
$144.4 million, a 45% increase over 2017.
- Positive results from three Phase III studies for SPN-812 in ADHD announced in
- Oxtellar XR® launched in
January 2019with expanded indication to include monotherapy for partial seizures.
Fourth quarter 2018 product prescriptions for Trokendi XR® and Oxtellar XR®, as reported by
|Q4 2018||Q4 2017||Change %||FY 2018||FY 2017||Change %|
Net product sales for the fourth quarter of 2018 were
In the fourth quarter of 2018, the increase in wholesaler and pharmacy channel inventory had the effect of increasing net product sales by approximately
|Net Product Sales ($millions)|
|Q4 2018||Q4 2017||Change %||FY 2018||FY 2017||Change %|
“We reported another year of strong operating results in 2018, driven by continued double-digit prescription growth for both Trokendi XR and Oxtellar XR,” said
SPN-812 – Novel non-stimulant for the treatment of ADHD
December 2018, the Company announced positive topline results from the two pediatric Phase III trials (P301 and P303) and from the first adolescent Phase III trial (P302). All three trials met the primary endpoint with robust statistical significance. Topline data from the second and final adolescent Phase III trial (P304) are expected by the end of the first quarter of 2019.
- 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 months, which we believe 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 pivotal Phase III studies for the treatment of bipolar disorder in the second half of 2019.
“We made significant progress in 2018 advancing our late-stage programs through clinical development, including announcing positive topline results from three Phase III trials for SPN-812 for treatment of ADHD,” said
Research and development expenses in the fourth quarter of 2018 were
Selling, general and administrative expenses in the fourth quarter of 2018 were
Research and development expenses for the full year 2018 were
Selling, general and administrative expenses for full year 2018 were
Operating Earnings and Earnings Per Share
Operating earnings in the fourth quarter of 2018 were
Net earnings (GAAP) in the fourth quarter of 2018 were
Weighted-average diluted common shares outstanding were approximately 54.1 million in the fourth quarter and full year 2018, as compared to approximately 53.5 million and 53.3 million in each of the respective prior year periods.
Balance Sheet Highlights
For full year 2019, the Company estimates net product sales, research and development expenses, operating earnings, and an effective tax rate as set forth below. This guidance assumes that the short-term higher levels of wholesaler and pharmacy channel inventory experienced in the fourth quarter of 2018 will revert to historical levels in 2019.
- Net product sales in the range of
$435 million to $455 million. Guidance reflects the Company’s expectation that wholesaler and pharmacy channel inventory levels will revert to historical 2018 levels, thereby affecting 2019 net product sales by approximately $10 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%.
The Company is pleased to announce that it will hold an Investor Day in
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 Fourth Quarter and Full Year 2018 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.|
|Consolidated Balance Sheets|
|(in thousands, except share amounts)|
|December 31,||December 31,|
|Cash and cash equivalents||$||192,248||$||100,304|
|Accounts receivable, net||102,922||65,586|
|Prepaid expenses and other current assets||8,888||6,521|
|Total current assets||493,487||228,451|
|Long term marketable securities||418,798||133,638|
|Property and equipment, net||4,095||5,124|
|Intangible assets, net||31,368||36,019|
|Deferred income taxes||29,683||20,843|
|Liabilities and stockholders' equity|
|Accrued sales deductions||107,063||68,343|
|Income taxes payable||12,377||15,938|
|Non-recourse liability related to sale of future royalties, current portion||2,183||4,283|
|Deferred licensing revenue||—||287|
|Total current liabilities||161,353||123,000|
|Deferred licensing revenue, net of current portion||—||1,149|
|Convertible notes, net||329,462||—|
|Non-recourse liability related to sale of future royalties, long term||22,575||22,258|
|Other non-current liabilities||11,398||10,577|
|Common stock, $0.001 par value, 130,000,000 shares authorized at December 31, 2018 and December 31, 2017; 52,316,583 and 51,314,850 shares issued and outstanding at December 31, 2018 and December 31, 2017, respectively||52||51|
|Additional paid-in capital||369,637||294,999|
|Accumulated other comprehensive loss, net of tax||(3,158||)||(747||)|
|Retained earnings (accumulated deficit)||86,492||(26,823||)|
|Total stockholders' equity||453,023||267,480|
|Total liabilities and stockholders' equity||$||977,811||$||424,464|
|Supernus Pharmaceuticals, Inc.|
|Consolidated Statements of Earnings|
|(in thousands, except share and per share data)|
|Three Months ended December 31,||Years Ended December 31,|
|Net product sales||$||113,494||$||86,334||$||399,871||$||294,097|
|Costs and expenses|
|Cost of product sales||4,188||4,154||15,356||15,215|
|Research and development||29,841||16,173||89,209||49,577|
|Selling, general and administrative||42,050||33,764||159,888||137,905|
|Total costs and expenses||76,079||54,091||264,453||202,697|
|Other income (expense)|
|Interest expense-nonrecourse liability related to sale of future royalties||(1,175||)||(160||)||(4,271||)||(1,434||)|
|Changes in fair value of derivative liabilities||—||—||—||76|
|Loss on extinguishment of debt||—||—||—||(295||)|
|Total other income (expense)||(1,088||)||717||(4,268||)||1,077|
|Earnings before income taxes||38,767||35,061||140,176||100,618|
|Income tax expense||12,874||21,403||29,183||43,334|
|Earnings per share:|
|Weighted-average number of common shares outstanding:|
Tel: (301) 838-2591
Office: (443) 213-0505
Mobile: (443) 377-4767
Source: Supernus Pharmaceuticals, Inc.