- Supernus Pharmaceuticals, Inc. (NASDAQ: SUPN), a specialty
pharmaceutical company focused on developing and commercializing
products for the treatment of central nervous system (CNS)
diseases, today reported record financial results for the second
quarter of 2018 and related Company developments.
Commercial UpdateSecond quarter 2018 product
prescriptions for Trokendi XR® and Oxtellar XR®, as reported by
IQVIA, totaled 214,841, a 35.5% increase over the second quarter of
2017.
Prescriptions |
|
Q2 2018 |
Q2 2017 |
Change % |
Trokendi XR |
177,052 |
124,089 |
42.7% |
Oxtellar XR |
37,789 |
34,468 |
9.6% |
Total |
214,841 |
158,557 |
35.5% |
Source: IQVIA
Net product sales for the second quarter of 2018 were $97.0
million, a 32.3% increase over $73.3 million in the second quarter
of 2017.
Net Product Sales ($ in millions) |
|
Q2 2018 |
Q2 2017 |
Change % |
Trokendi XR |
$76.4 |
$56.0 |
36.4% |
Oxtellar XR |
$20.6 |
$17.3 |
19.1% |
Total |
$97.0 |
$73.3 |
32.3% |
“Solid commercial execution has enabled Supernus to generate
another strong quarter of growth, setting a new record for both
Trokendi XR and Oxtellar XR quarterly net product sales,” said Jack
Khattar, President and CEO of Supernus Pharmaceuticals.
Progress of Product PipelineSPN-812 – Novel
non-stimulant for the treatment of ADHD
- The program consists of four three-arm, placebo-controlled
trials: P301 and P302 trials in patients 6-11 years old, and P303
and P304 trials in adolescent patients.
- Enrollment is complete in the P301 trial, with data expected in
the fourth quarter of 2018.
- The remaining three trials are at approximately 89% enrollment,
with data expected in the first quarter of 2019.
- Roll-over from the four Phase III trials to the open label
extension study is approximately 90%.
SPN-810 – Treatment of Impulsive Aggression in patients with
ADHD
- Enrollment in the Phase III pediatric trials, P301 and P302, is
approximately 91% and 77%, respectively.
- The Company anticipates having data from P301 by the first
quarter of 2019 and data from P302 by mid-2019.
- Roll-over from the two Phase III trials to the open label
extension study continues at approximately 90%.
- Patient screening has been initiated in the Phase III trial
treating adolescents.
Oxtellar XR –Treatment of Bipolar Disorder
- The Company is planning to initiate pivotal Phase III studies
for treatment of bipolar disorder in the second half of 2019.
“As we enter the second half of 2018, we remain focused on the
successful completion of our clinical programs and look forward to
providing top-line data from the first Phase III trial for SPN-812
in the fourth quarter of 2018,” said Jack Khattar.
Operating ExpensesResearch and development
expenses in the second quarter of 2018 were $20.0 million, as
compared to $10.8 million in the same quarter last year. The
increase was due primarily to the initiation of the four Phase III
clinical trials for SPN-812 in the second half of 2017 and to a
lesser extent, the open-label extension trials for SPN-812 and
SPN-810.
Selling, general and administrative expenses in the second
quarter of 2018 were $40.1 million, as compared to $35.1 million in
the same quarter last year. The increase was due to the expansion
of the salesforce by 40 salespeople, which were fully deployed in
the fourth quarter of 2017; marketing programs to support the
Company’s commercial products; and an increase in share-based
compensation.
Operating Earnings and Earnings Per
ShareOperating earnings in the second quarter of 2018 were
$35.7 million, a 37.0% increase over $26.1 million in the same
period the prior year. The improvement in operating earnings was
primarily due to increased net product sales, partially offset by
increased operating expenses.
GAAP net earnings in the second quarter of 2018 were $30.7
million, as compared to $17.4 million in the same period last year.
In addition to higher operating income, GAAP net earnings for the
second quarter of 2018 benefited from the reduction in the
statutory U.S. federal income tax rate and from stock option
exercises.
GAAP diluted earnings per share (EPS) were $0.57 in the second
quarter of 2018, compared to $0.32 in the second quarter of 2017.
Net interest expense and non-cash deferred financing costs
associated with the sale of $402.5 million of convertible senior
notes in March 2018 had the effect of reducing GAAP net earnings by
approximately $4.3 million, or $0.08 per diluted share, in the
second quarter of 2018.
Weighted-average diluted common shares outstanding were
approximately 54.2 million in the second quarter of 2018, as
compared to approximately 53.2 million in the second quarter of
2017.
As of June 30, 2018, the Company had $677.7 million in cash,
cash equivalents, marketable securities and long term marketable
securities, as compared to $273.7 million at December 31, 2017.
This increase reflects net proceeds of $364.9 million from the
issuance of convertible senior notes and warrants, partially offset
by purchases of convertible note hedges in March 2018, as well as
increased cash from operations in the six months ended June 30,
2018.
Financial GuidanceFor full year 2018, the
Company is updating its prior guidance as set forth below:
- Net product sales in the range of $385 million to $400 million,
compared to the previously expected range of $375
million to $400 million.
- Research and development expenses of approximately $80
million.
- Operating earnings in the range of $130 million to $140
million, compared to the previously expected range of $125
million to $135 million. The Company continues to expect
approximately $7 million of licensing and non-cash royalty
revenue.
- The Company expects an effective tax rate of approximately 23%
to 25% for the third and fourth quarters of 2018.
Conference Call DetailsThe Company will hold a
conference call hosted by Jack Khattar, President and Chief
Executive Officer, and Greg Patrick, Vice President and Chief
Financial Officer, to discuss these results at 9:00 a.m. Eastern
Time, on Wednesday, August 8, 2018. An accompanying webcast also
will be provided.
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) 288-1043International dial-in: (970)
315-0267Conference ID: 7484048Conference Call Name: Supernus
Pharmaceuticals Second Quarter 2018 Earnings 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, Inc. is a specialty pharmaceutical company focused
on developing and commercializing products for the treatment of
central nervous system 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 psychiatry, including SPN-810 for the
treatment of Impulsive Aggression in ADHD patients and SPN-812 for
the treatment of ADHD.
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 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 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.
|
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|
Supernus Pharmaceuticals, Inc. |
Consolidated Balance Sheets |
(in thousands, except share
amounts) |
|
|
|
|
|
|
|
|
|
June 30, |
|
December
31, |
|
|
2018 |
|
|
2017 |
|
Assets |
|
(unaudited) |
|
|
|
Current
assets |
|
|
|
|
|
|
Cash and
cash equivalents |
|
$ |
35,205 |
|
|
$ |
100,304 |
|
Marketable securities |
|
|
139,208 |
|
|
|
39,736 |
|
Accounts
receivable, net |
|
|
74,842 |
|
|
|
65,586 |
|
Inventories, net |
|
|
20,680 |
|
|
|
16,304 |
|
Prepaid
expenses and other current assets |
|
|
14,581 |
|
|
|
6,521 |
|
Total current assets |
|
|
284,516 |
|
|
|
228,451 |
|
Long term
marketable securities |
|
|
503,312 |
|
|
|
133,638 |
|
Property
and equipment, net |
|
|
4,897 |
|
|
|
5,124 |
|
Intangible assets, net |
|
|
33,794 |
|
|
|
36,019 |
|
Other
non-current assets |
|
|
752 |
|
|
|
389 |
|
Deferred
income taxes |
|
|
25,528 |
|
|
|
20,843 |
|
|
|
|
|
|
|
|
Total
assets |
|
$ |
852,799 |
|
|
$ |
424,464 |
|
|
|
|
|
|
|
|
Liabilities and
stockholders' equity |
|
|
|
|
|
|
Current
liabilities |
|
|
|
|
|
|
Accounts
payable |
|
$ |
2,943 |
|
|
$ |
6,844 |
|
Accrued
sales deductions |
|
|
70,044 |
|
|
|
68,343 |
|
Accrued
expenses |
|
|
29,288 |
|
|
|
27,305 |
|
Income
taxes payable |
|
|
— |
|
|
|
15,938 |
|
Non-recourse liability related to sale of future royalties, current
portion |
|
|
1,659 |
|
|
|
4,283 |
|
Deferred
licensing revenue |
|
|
— |
|
|
|
287 |
|
Total current liabilities |
|
|
103,934 |
|
|
|
123,000 |
|
Deferred
licensing revenue, net of current portion |
|
|
— |
|
|
|
1,149 |
|
Convertible notes, net |
|
|
321,920 |
|
|
|
— |
|
Non-recourse liability related to sale of future royalties, long
term |
|
|
23,867 |
|
|
|
22,258 |
|
Other
non-current liabilities |
|
|
12,586 |
|
|
|
10,577 |
|
Total
liabilities |
|
|
462,307 |
|
|
|
156,984 |
|
|
|
|
|
|
|
|
Stockholders'
equity |
|
|
|
|
|
|
Common
stock, $0.001 par value, 130,000,000 shares authorized at |
|
|
|
|
|
|
June 30,
2018 and December 31, 2017; 52,179,334 and 51,314,850 shares issued
and outstanding at June 30, 2018 and December 31, 2017,
respectively |
|
|
52 |
|
|
|
51 |
|
Additional paid-in capital |
|
|
361,971 |
|
|
|
294,999 |
|
Accumulated other comprehensive loss, net of tax |
|
|
(4,119 |
) |
|
|
(747 |
) |
Retained
earnings (accumulated deficit) |
|
|
32,588 |
|
|
|
(26,823 |
) |
Total
stockholders' equity |
|
|
390,492 |
|
|
|
267,480 |
|
|
|
|
|
|
|
|
Total
liabilities and stockholders' equity |
|
$ |
852,799 |
|
|
$ |
424,464 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supernus Pharmaceuticals, Inc. |
Consolidated Statements of
Earnings |
(in thousands, except share and per share
data) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months ended June 30, |
|
Six Months ended June 30, |
|
2018 |
|
|
2017 |
|
|
|
2018 |
|
|
2017 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(unaudited) |
|
(unaudited) |
Revenue |
|
|
|
|
|
|
|
|
|
|
|
Net
product sales |
$ |
97,030 |
|
|
$ |
73,328 |
|
|
$ |
186,150 |
|
|
$ |
129,697 |
|
Royalty
revenue |
|
1,758 |
|
|
|
1,179 |
|
|
|
3,067 |
|
|
|
2,328 |
|
Licensing
revenue |
|
750 |
|
|
|
1,322 |
|
|
|
750 |
|
|
|
1,380 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
revenue |
|
99,538 |
|
|
|
75,829 |
|
|
|
189,967 |
|
|
|
133,405 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Costs and expenses |
|
|
|
|
|
|
|
|
|
|
|
Cost of
product sales |
|
3,683 |
|
|
|
3,861 |
|
|
|
6,961 |
|
|
|
6,809 |
|
Research
and development |
|
20,038 |
|
|
|
10,823 |
|
|
|
38,946 |
|
|
|
20,425 |
|
Selling,
general and administrative |
|
40,097 |
|
|
|
35,078 |
|
|
|
76,946 |
|
|
|
63,316 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total costs and
expenses |
|
63,818 |
|
|
|
49,762 |
|
|
|
122,853 |
|
|
|
90,550 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
earnings |
|
35,720 |
|
|
|
26,067 |
|
|
|
67,114 |
|
|
|
42,855 |
|
Other income
(expense) |
|
|
|
|
|
|
|
|
|
|
|
Interest
income |
|
3,664 |
|
|
|
656 |
|
|
|
4,870 |
|
|
|
1,187 |
|
Interest
expense |
|
(4,324 |
) |
|
|
(58 |
) |
|
|
(5,041 |
) |
|
|
(147 |
) |
Interest
expense-nonrecourse liability related to sale of future
royalties |
|
(1,204 |
) |
|
|
(160 |
) |
|
|
(1,905 |
) |
|
|
(1,119 |
) |
Changes
in fair value of derivative liabilities |
|
— |
|
|
|
23 |
|
|
|
— |
|
|
|
76 |
|
Loss on
extinguishment of debt |
|
— |
|
|
|
(103 |
) |
|
|
— |
|
|
|
(204 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Total other income
(expense) |
|
(1,864 |
) |
|
|
358 |
|
|
|
(2,076 |
) |
|
|
(207 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Earnings before income
taxes |
|
33,856 |
|
|
|
26,425 |
|
|
|
65,038 |
|
|
|
42,648 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Income
tax expense |
|
3,119 |
|
|
|
9,057 |
|
|
|
7,949 |
|
|
|
14,983 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net earnings |
$ |
30,737 |
|
|
$ |
17,368 |
|
|
$ |
57,089 |
|
|
$ |
27,665 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Earnings per
share: |
|
|
|
|
|
|
|
|
|
|
|
Basic |
$ |
0.59 |
|
|
$ |
0.34 |
|
|
$ |
1.10 |
|
|
$ |
0.55 |
|
Diluted |
$ |
0.57 |
|
|
$ |
0.32 |
|
|
$ |
1.06 |
|
|
$ |
0.52 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average number of common shares outstanding: |
|
|
|
|
|
|
|
|
|
|
Basic |
|
51,919,894 |
|
|
|
50,530,968 |
|
|
|
51,729,243 |
|
|
|
50,345,830 |
|
Diluted |
|
54,203,308 |
|
|
|
53,223,714 |
|
|
|
54,021,941 |
|
|
|
53,026,323 |
|
|
|
|
|
|
|
|
|
|
|
|
|
CONTACTS:
Jack A. Khattar, President and CEOGregory S. Patrick, Vice
President and CFOSupernus Pharmaceuticals, Inc.Tel: (301)
838-2591
or
INVESTOR CONTACT:Peter VozzoWestwicke PartnersOffice: (443)
213-0505Mobile: (443) 377-4767Email: peter.vozzo@westwicke.com
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