Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical
company focused on developing and commercializing products for the
treatment of central nervous system (CNS) diseases, today reported
financial results for the first quarter of 2021, and associated
Company developments.
“The approval of Qelbree provides pediatric patients living with
ADHD a therapy with proven efficacy and a tolerable safety profile,
and that is not a controlled substance,” said Jack Khattar,
President and CEO of Supernus Pharmaceuticals. “Our Qelbree
commercial launch activities are ongoing and include engagement
with both physicians and patient groups who have expressed great
interest in this unique new alternative for the treatment of
ADHD.”
Net Product Sales
First quarter 2021 net product sales were $128.4
million, 39% higher than the same period in 2020.
Net Product
Sales |
|
|
|
|
|
($ in millions) |
Q1 2021 |
|
Q1 2020 |
|
Change % |
Trokendi XR® |
$ |
71.8 |
|
|
$ |
68.6 |
|
|
5 |
% |
Oxtellar XR® |
27.4 |
|
|
23.9 |
|
|
14 |
% |
APOKYN® |
21.7 |
|
|
— |
|
|
** |
|
MYOBLOC® |
4.3 |
|
|
— |
|
|
** |
|
XADAGO® |
3.2 |
|
|
— |
|
|
** |
|
Net Product Sales |
$ |
128.4 |
|
|
$ |
92.5 |
|
|
39 |
% |
Qelbree Launch Update
- In April 2021, the U.S. Food and Drug
Administration (FDA) approved Qelbree for the treatment of
attention-deficit hyperactivity disorder (ADHD) in pediatric
patients 6 to 17 years of age. The Company plans to make Qelbree
available in the U.S. during the second quarter of 2021.
- Supernus will conduct post-marketing
commitment studies, including a new study of Qelbree in preschool
aged children with ADHD, 4 to 5 years of age. The completion of
these studies responds to a written request from the FDA and should
therefore result in the FDA granting an additional 6 months of
market exclusivity.
Product Pipeline Update
Qelbree (viloxazine, extended-release capsules) - Novel
non-stimulant for the treatment of ADHD in adults
- In December 2020, the Company
announced positive results from a Phase III trial in adult patients
with ADHD and plans to submit a supplemental New Drug Application
(sNDA) to the FDA for Qelbree in adults in the third quarter of
2021.
SPN-830 (apomorphine infusion pump) - Continuous treatment of
motor fluctuations (“on-off” episodes) in PD
- The company recently met with the FDA
to discuss the path forward for resubmission of the SPN-830 NDA.
The FDA provided additional clarity related to the contents of the
November 2020 Refusal to File (RTF) letter and the requirements for
resubmission. The Company now plans to resubmit the SPN-830 NDA in
the second half of 2021.
SPN-820 - Novel first-in-class activator of mTORC1
- SPN-820 has advanced to a Phase II
clinical program in treatment-resistant depression following the
successful completion of a multiple-ascending dose (MAD) study in
healthy volunteers. In the MAD study, SPN-820 exhibited a favorable
safety and tolerability profile across a broad range of potentially
therapeutic doses.
- The Company expects to initiate a
randomized Phase II clinical study in treatment-resistant
depression by the end of 2021.
Financial Highlights
First quarter 2021 operating earnings were $13.2
million, as compared to $29.0 million in the first quarter 2020. In
the first quarter of 2021, the Company recorded non-cash research
and development expense of $15 million related to the equity
investment in Navitor as a result of the accounting impact of the
March 2021 Navitor corporate restructuring and non-cash contingent
consideration expense of $1 million associated with the 2020 USWM
acquisition. Operating earnings for the first quarter of 2021
included amortization of intangible assets expense of $6.0 million,
compared to $1.3 million in the first quarter of 2020.
First quarter 2021 net earnings and diluted earnings per share
were $5.7 million and $0.11, respectively, as compared to $21.5
million, or $0.40 per diluted share, in the same period last
year.
As of March 31, 2021, the Company had $807.7 million in cash,
cash equivalents and marketable securities, compared to $772.9
million as of December 31, 2020.
Full Year 2021 Financial Guidance
For full year 2021, the Company reiterates its prior financial
guidance and added full year 2021 effective tax rate guidance as
set forth below:
|
Full Year 2021 Guidance($ in millions) |
Total revenues1 |
$550 - $580 |
Combined R&D and SG&A
expenses2 |
$380 - $410 |
Operating earnings3 |
$65 - $90 |
Amortization of intangible
assets |
$24 |
Effective Tax Rate4 |
28% - 31% |
___________________________________________
1) Total revenues includes net product sales
and royalty revenue. Includes $10 million for
Qelbree™ net product sales.2) Combined
research and development and selling, general and administrative
expenses.3) Operating earnings include
amortization of intangible assets and contingent consideration
expense.4) The full year 2021 effective tax rate
guidance of 28% - 31% is above the normally expected range of 26% -
28% due to the effect of discrete tax items in the period.
Conference Call Details
The Company will hold a conference call hosted
by Jack Khattar, President and Chief Executive Officer and Jim
Kelly, Executive Vice President and Chief Financial Officer, to
discuss these results at 4:30 p.m. Eastern Time, today, May 5,
2021.
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: |
9275942 |
Conference Call Name: |
Supernus Pharmaceuticals First Quarter 2021 Results Conference
Call |
Following 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 is a biopharmaceutical
company focused on developing and commercializing products for the
treatment of central nervous system (CNS) diseases.
Our diverse neuroscience portfolio includes approved treatments
for epilepsy, migraine, ADHD, hypomobility in Parkinson’s disease,
cervical dystonia and chronic sialorrhea. We are developing a broad
range of novel CNS product candidates including new potential
treatments for hypomobility in Parkinson’s disease, epilepsy,
depression, and rare CNS disorders.
For more information, please visit
www.supernus.com
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 revenue and expenditures; the Company’s
ability to increase the number of prescriptions written for each of
its products; the Company’s ability to increase its revenues; the
Company’s ability to commercialize its products including Qelbree;
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; the Company’s ability to receive,
and the timing of any receipt of, regulatory approvals to develop
and commercialize the Company’s product candidates including
SPN-830 and SPN-812 for adult ADHD patients; 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 Securities and Exchange Commission made pursuant
to Section 13 or 15(d) of the Securities Exchange Act of 1934, as
amended. The Company undertakes no obligation to update the
information in this press release to reflect events or
circumstances after the date hereof or to reflect the occurrence of
anticipated or unanticipated events.
Supernus
Pharmaceuticals, Inc.Condensed Consolidated
Balance Sheets(in thousands, except share
data)
|
March 31, 2021 |
|
December 31, 2020 |
|
(unaudited) |
|
|
Assets |
|
|
|
Current assets |
|
|
|
Cash and cash equivalents |
$ |
255,642 |
|
|
$ |
288,640 |
|
Marketable securities |
135,459 |
|
|
133,893 |
|
Accounts receivable, net |
127,065 |
|
|
140,877 |
|
Inventories, net |
50,226 |
|
|
48,325 |
|
Prepaid expenses and other current assets |
17,631 |
|
|
18,682 |
|
Total current assets |
586,023 |
|
|
630,417 |
|
Long term marketable securities |
416,566 |
|
|
350,359 |
|
Property and equipment, net |
37,950 |
|
|
37,824 |
|
Intangible assets, net |
358,736 |
|
|
364,342 |
|
Goodwill |
77,911 |
|
|
77,911 |
|
Other assets |
30,257 |
|
|
43,249 |
|
Total
assets |
$ |
1,507,443 |
|
|
$ |
1,504,102 |
|
|
|
|
|
Liabilities and
stockholders’ equity |
|
|
|
Current liabilities |
|
|
|
Accounts payable and accrued liabilities |
$ |
70,099 |
|
|
$ |
78,934 |
|
Accrued product returns and rebates |
128,736 |
|
|
126,192 |
|
Contingent consideration, current portion |
31,520 |
|
|
30,900 |
|
Other current liabilities |
10,457 |
|
|
9,082 |
|
Total current liabilities |
240,812 |
|
|
245,108 |
|
Convertible notes, net |
366,038 |
|
|
361,751 |
|
Contingent consideration, long term |
46,200 |
|
|
45,800 |
|
Operating lease liabilities, long term |
28,532 |
|
|
28,579 |
|
Deferred income tax liabilities |
31,742 |
|
|
35,215 |
|
Other liabilities |
39,675 |
|
|
42,791 |
|
Total liabilities |
752,999 |
|
|
759,244 |
|
|
|
|
|
Stockholders’
equity |
|
|
|
Common stock, $0.001 par value; 130,000,000 shares authorized;
52,994,137 and 52,868,482 shares issued and outstanding as of March
31, 2021 and December 31, 2020, respectively |
53 |
|
|
53 |
|
Additional paid-in capital |
415,950 |
|
|
409,332 |
|
Accumulated other comprehensive earnings, net of tax |
6,249 |
|
|
8,975 |
|
Retained earnings |
332,192 |
|
|
326,498 |
|
Total stockholders’
equity |
754,444 |
|
|
744,858 |
|
Total liabilities and
stockholders’ equity |
$ |
1,507,443 |
|
|
$ |
1,504,102 |
|
Supernus
Pharmaceuticals, Inc.Condensed Consolidated
Statements of Earnings(in thousands, except share
and per share data)
|
Three Months ended March
31, |
|
2021 |
|
2020 |
|
(unaudited) |
Revenues |
|
|
|
Net product sales |
$ |
128,381 |
|
|
|
$ |
92,490 |
|
|
Royalty revenues |
2,551 |
|
|
|
2,486 |
|
|
Total revenues |
130,932 |
|
|
|
94,976 |
|
|
|
|
|
|
Costs and expenses |
|
|
|
Cost of goods sold (a) |
14,954 |
|
|
|
4,152 |
|
|
Research and development |
34,280 |
|
|
|
18,937 |
|
|
Selling, general and administrative |
61,457 |
|
|
|
41,614 |
|
|
Amortization of intangible assets |
6,007 |
|
|
|
1,261 |
|
|
Contingent consideration expense |
1,020 |
|
|
|
— |
|
|
Total costs and expenses |
117,718 |
|
|
|
65,964 |
|
|
|
|
|
|
Operating earnings |
13,214 |
|
|
|
29,012 |
|
|
|
|
|
|
Other income (expense) |
|
|
|
Interest expense |
(6,097 |
) |
|
|
(5,755 |
) |
|
Interest and other income, net |
3,812 |
|
|
|
5,777 |
|
|
Total other income
(expense) |
(2,285 |
) |
|
|
22 |
|
|
|
|
|
|
Earnings before income
taxes |
10,929 |
|
|
|
29,034 |
|
|
|
|
|
|
Income tax expense |
5,235 |
|
|
|
7,516 |
|
|
Net earnings |
$ |
5,694 |
|
|
|
$ |
21,518 |
|
|
|
|
|
|
Earnings per share |
|
|
|
Basic |
$ |
0.11 |
|
|
|
$ |
0.41 |
|
|
Diluted |
$ |
0.11 |
|
|
|
$ |
0.40 |
|
|
|
|
|
|
Weighted-average shares
outstanding |
|
|
|
Basic |
52,927,467 |
|
|
|
52,534,787 |
|
|
Diluted |
54,196,971 |
|
|
|
53,581,051 |
|
|
___________________________________________
(a) Excludes amortization of acquired intangible assets
CONTACTS:
Jack A. Khattar, President and CEOJim Kelly, Executive Vice
President and CFOSupernus Pharmaceuticals, Inc.Tel: (301)
838-2591
or
INVESTOR CONTACT:Peter VozzoWestwicke/ICROffice: (443)
213-0505Mobile: (443) 377-4767Email: peter.vozzo@westwicke.com
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