Full Press Release Details
Supernus Announces Fourth Quarter and
Full Year 2019 Financial Results
| - | Fourth quarter and full year 2019 total revenue of $100.4 million and $392.8 million, respectively. | |
| - | Fourth quarter and full year 2019 net product sales of $97.9 million and $383.4 million, respectively. | |
| - | Fourth quarter and full year 2019 operating earnings of $40.8 million and $148.6 million, respectively. | |
| - | FDA assigned PDUFA target action date of November 8, 2020 for 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. |
Md., February 25, 2020 - Supernus Pharmaceuticals, Inc. (NASDAQ: SUPN), a
pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases,
today reported financial results for the fourth quarter and full year of 2019, and associated Company developments.
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.
| Prescriptions | ||||||||||||
| FY 2019 | FY 2018 | Change % | ||||||||||
| Trokendi XR | 672,485 | 638,923 | 5.3 | % | ||||||||
| Oxtellar XR | 163,914 | 147,488 | 11.1 | % | ||||||||
| Total | 836,399 | 786,411 | 6.4 | % |
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 $10 million higher than would have been
otherwise; i.e., had inventory levels remained consistent quarter to quarter. The inventory build in the fourth quarter of 2018
was then effectively reversed in the first quarter of 2019, causing net product sales to be $10 million lower in both the first
quarter and full year 2019 than would have been otherwise.
Net product sales for full year 2019 were $383.4 million, compared
to $399.9 million for full year 2018. Net product sales for the fourth quarter of 2019 were $97.9 million, compared to $113.5 million
in the fourth quarter of 2018. The decrease in both quarter over quarter and year over year comparisons is due to the aforementioned
increase in inventory holdings in the fourth quarter of 2018.
In addition, net product sales in both the fourth quarter and
full year 2019 were adversely impacted by continued pressure on gross-to-net deductions, as compared to 2018.
| Net Product Sales ($ in millions) | ||||||||||||
| FY 2019 | FY 2018 | Change % | ||||||||||
| Trokendi XR | $ | 295.2 | $ | 315.3 | (6.4 | )% | ||||||
| Oxtellar XR | 88.2 | 84.6 | 4.3 | % | ||||||||
| Total | $ | 383.4 | $ | 399.9 | (4.1 | )% |
Progress of Product Pipeline
SPN-812 - Novel non-stimulant for the treatment of ADHD
SPN-810 - Novel treatment of Impulsive Aggression (IA) in
SPN-604 - Novel treatment of bipolar disorder
"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 Jack Khattar, President and CEO of Supernus.
"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." Mr. Khattar added, "We extend our sincere thanks to all our employees for working diligently to
complete the SPN-810 studies, and to all our patients, their families, and our investigators for participating in our studies."
Research and development (R&D) expenses for full year 2019
were $69.1 million, lower than the $89.2 million in 2018. This decrease is primarily due to the one-time upfront expense of approximately
$14 million incurred in the fourth quarter of 2018 for the acquisition of Biscayne Neurotherapeutics, Inc. (Biscayne). To a lesser
extent, the completion of four Phase III clinical trials for SPN-812 contributed to the year-over-year decline. These reductions
were partially offset by SPN-812 manufacturing costs in 2019 to support the Company's NDA submission.
Selling, general and administrative (SG&A) expenses for
full year 2019 were $158.4 million, essentially unchanged from $159.9 million in 2018.
R&D expenses in the fourth quarter of 2019 were $19.8 million,
lower than the $29.8 million in the same quarter last year. This decrease was primarily due to the one-time upfront expense of
approximately $14 million incurred in the fourth quarter of 2018 for the acquisition of Biscayne.
SG&A expenses in the fourth quarter of 2019 were $35.7 million,
lower than the $42.1 million in the same quarter last year. This decrease is primarily due to expenses
incurred in the fourth quarter of 2018 for the development and production of promotional materials
and marketing programs associated with the launch of the monotherapy indication for Oxtellar XR. In addition, employee-related
Operating Earnings and Earnings Per Share
Operating earnings for full year 2019 were $148.6 million, compared
to $144.4 million in 2018. The increase in operating earnings is primarily due to lower R&D and SG&A expenses in 2019.
Operating earnings for the full year 2019 were negatively impacted by the aforementioned inventory drawdown in the first quarter
of 2019. This resulted in full year 2018 operating earnings being $10 million higher, and the full year 2019 operating earnings
being $10 million lower than would have been otherwise.
Operating earnings in the fourth quarter of 2019 were $40.8
million, compared to $39.9 million in the fourth quarter of 2018. The quarterly comparison was negatively impacted by the aforementioned
increase in channel inventory holdings in the fourth quarter of 2018. The increase in channel inventory holdings in 2018 caused
the fourth quarter 2018 operating earnings to be higher by approximately $10 million than would have been otherwise.
Net earnings (GAAP) were $113.1 million for full year 2019,
or $2.10 per diluted share, compared to $111.0 million, or $2.05 per diluted share, for full year 2018.
Net earnings (GAAP) in the fourth quarter of 2019 were $33.1
million, or $0.62 per diluted share, an increase of 29% on a diluted share basis, as compared to $25.9 million, or $0.48 per diluted
share, in the same period last year.
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
As of December 31, 2019, the Company had $938.8 million
in cash, cash equivalents, marketable securities and long term marketable securities, as compared to $774.8 million at December 31,
2018. This increase primarily reflects cash generated from operations in 2019.
For full year 2020, the Company estimates net product sales
and operating earnings as set forth below:
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
Conference Call Details
The Company will hold a conference call hosted by Jack Khattar,
President and Chief Executive Officer, and Greg Patrick, Senior Vice President and Chief Financial Officer, to discuss these results
at 9:00 a.m. Eastern Time, on Wednesday, February 26, 2020.
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: | 7796907 |
| Conference Call Name: | Supernus Pharmaceuticals Fourth Quarter and Full Year 2019 Earnings Conference Call |
the live call, a replay will be available on the Company's website, www.supernus.com,
under "Investor Relations".
About Supernus Pharmaceuticals, Inc.
Supernus Pharmaceuticals, Inc. is a pharmaceutical company focused
on developing and commercializing products for the treatment of central nervous system (CNS) diseases. The Company currently markets
Trokendi XR (extended-release topiramate) for the prophylaxis of migraine and the treatment of epilepsy, and Oxtellar XR
(extended-release oxcarbazepine) for the treatment of epilepsy. The Company is also developing several product candidates to address
large market opportunities in the CNS market, including SPN-812 for the treatment of ADHD and SPN-604 for the treatment of bipolar
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