Supernus Announces Fourth Quarter and Full Year 2019 Financial Results
- Fourth quarter and full year 2019 total revenue of
$100.4 millionand $392.8 million, respectively.
- Fourth quarter and full year 2019 net product sales of
$97.9 millionand $383.4 million, respectively.
- Fourth quarter and full year 2019 operating earnings of
$40.8 millionand $148.6 million, respectively.
- FDA assigned PDUFA target action date of
November 8, 2020for review of SPN-812 New Drug Application.
- Phase III P302 trial of SPN-810 for the treatment of IA in ADHD patients 6 to 11 years old did not meet primary endpoint.
Full year 2019 product prescriptions for Trokendi XR® and Oxtellar XR®, as reported by IQVIA, totaled 836,399, a 6.4% increase over full year 2018. Fourth quarter 2019 product prescriptions for Trokendi XR and Oxtellar XR totaled 212,780, a 1.4% increase over the fourth quarter of 2018.
|FY 2019||FY 2018||Change %|
As previously disclosed, wholesalers, distributors and pharmacies increased their inventory levels of the Company’s products in the fourth quarter of 2018. The Company estimates that this caused net product sales in both the fourth quarter and full year 2018 to be approximately
Net product sales for full year 2019 were
In addition, net product sales in both the fourth quarter and full year 2019 were adversely impacted by continued pressure on gross-to-net deductions, as compared to 2018.
|Net Product Sales
($ in millions)
Progress of Product Pipeline
SPN-812 - Novel non-stimulant for the treatment of ADHD
U.S. Food and Drug Administration(FDA) accepted for review a New Drug Application (NDA) for SPN-812 for the treatment of ADHD, with a Prescription Drug User Fee Act (PDUFA) target action date of November 8, 2020.
- The Company plans to launch SPN-812 at the end of 2020, if approved by the FDA.
- The Company expects to complete enrollment in the ongoing Phase III program in adult patients by the end of 2020.
SPN-810 - Novel treatment of Impulsive Aggression (IA) in patients with ADHD
- Phase III P302 trial in patients 6 to 11 years old did not meet its primary endpoint. The study was a randomized, double-blind, placebo controlled, multicenter, parallel group clinical trial in patients diagnosed with ADHD. Patients receiving SPN-810 36 mg showed a median percent reduction of 51.3% in the average weekly frequency of impulsive aggression episodes from baseline that was not statistically significant (p=0.961) compared to placebo. Consistent with the P301 trial, the drug was safe and well tolerated.
- The Company will halt all development activities on SPN-810 in IA.
SPN-604 - Novel treatment of bipolar disorder
- The Company expects enrollment in the ongoing pivotal Phase III monotherapy trial for the treatment of bipolar disorder to continue through 2021.
“With our NDA for SPN-812 in ADHD accepted for review by the FDA, we continue to prepare the Company for the commercial launch of SPN-812 and look forward to bringing this important new treatment option to patients and physicians. If approved by the FDA, SPN-812 has the potential of becoming the first novel treatment to be introduced in the ADHD market in more than a decade” said
“While we are certainly disappointed with the results from the second trial on SPN-810, Supernus continues to invest in R&D programs and is planning to provide an R&D update later in the year.”
Research and development (R&D) expenses for full year 2019 were
Selling, general and administrative (SG&A) expenses for full year 2019 were
R&D expenses in the fourth quarter of 2019 were
SG&A expenses in the fourth quarter of 2019 were
Operating Earnings and Earnings Per Share
Operating earnings for full year 2019 were
Operating earnings in the fourth quarter of 2019 were
Net earnings (GAAP) were
Net earnings (GAAP) in the fourth quarter of 2019 were
Weighted-average diluted common shares outstanding were approximately 53.8 million for the full year 2019 and 53.6 million for the fourth quarter of 2019, as compared to approximately 54.1 million for each of the respective prior year periods.
Balance Sheet Highlights
For full year 2020, the Company estimates net product sales and operating earnings as set forth below:
- Net product sales to range from
$360 millionto $390 million.
- Operating earnings to range from
$70 millionto $100 million.
Other than the impact from the addition of salesforce personnel at the end of 2020 in anticipation of the launch of SPN-812, SG&A expenses are expected to be consistent quarter to quarter in 2020.
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 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
Consolidated Balance Sheets
(in thousands, except share data)
|Cash and cash equivalents||$||181,381||$||192,248|
|Accounts receivable, net||87,332||102,922|
|Prepaid expenses and other current assets||11,611||8,888|
|Total current assets||472,644||493,487|
|Long term marketable securities||591,773||418,798|
|Property and equipment, net||17,068||4,095|
|Intangible assets, net||24,840||31,368|
|Deferred income taxes||32,063||29,683|
|Liabilities and stockholders’ equity|
|Accrued product returns and rebates||107,629||107,063|
|Accrued expenses and other current liabilities||37,130||36,535|
|Income taxes payable||2,443||12,377|
|Nonrecourse liability related to sale of future royalties; current portion||3,244||2,183|
|Total current liabilities||160,587||161,353|
|Convertible notes, net||345,170||329,462|
|Nonrecourse liability related to sale of future royalties; long term||19,248||22,575|
|Lease liabilities, long term||30,440||—|
|Additional paid-in capital||388,410||369,637|
|Accumulated other comprehensive earnings (loss), net of tax||7,417||(3,158||)|
|Total stockholders’ equity||595,428||453,023|
|Total liabilities and stockholders’ equity||$||1,160,282||$||977,811|
Consolidated Statements of Earnings
(in thousands, except share and per share data)
|Three Months ended
|Net product sales||$||97,909||$||113,494||$||383,400||$||399,871|
|Costs and expenses|
|Cost of goods sold||4,113||4,188||16,660||15,356|
|Research and development||19,792||29,841||69,099||89,209|
|Selling, general and administrative||35,725||42,050||158,425||159,888|
|Total costs and expenses||59,630||76,079||244,184||264,453|
|Other (expense) income|
|Interest income, net||5,966||4,512||21,623||13,843|
|Total other (expense) income||96||(1,088||)||(1,084||)||(4,268||)|
|Earnings before income taxes||40,912||38,767||147,487||140,176|
|Income tax expense||7,783||12,874||34,431||29,183|
|Earnings per share|
|Weighted-average shares outstanding|
Tel: (301) 838-2591
Office: (443) 213-0505
Mobile: (443) 377-4767
Source: Supernus Pharmaceuticals, Inc.