Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical
company focused on developing and commercializing products for the
treatment of central nervous system (CNS) diseases, today announced
financial results for the first quarter of 2024 and associated
Company developments.
"We are pleased to announce another strong
quarter for Qelbree, which delivered robust growth of 75% in net
sales compared to the same quarter in the prior year," said Jack
Khattar, President and CEO of Supernus. "We remain focused on
driving the Company's long-term growth as we complete the
transition from our legacy products to our growth products and as
we progress our pipeline of novel product candidates."
Business Highlights
Qelbree Update
- Total
IQVIA prescriptions were 176,503 for first quarter 2024, an
increase of 31% compared to the prior year period.
- Patient
enrollment is ongoing in the Phase IV open-label study to assess
the efficacy of Qelbree over the course of 14 weeks of treatment in
approximately 500 adults with attention deficit hyperactivity
disorder (ADHD) and mood symptoms. The primary outcome measure is
change from baseline in the Adult ADHD Investigator Symptom Rating
Scale (AISRS).
Product Pipeline Update
SPN-830 (apomorphine infusion device) for
treatment of Parkinson's disease (PD)
- In April
2024, the U.S. Food and Drug Administration (FDA) issued a Complete
Response Letter (CRL) in response to the Company’s New Drug
Application (NDA) for SPN-830. The CRL indicates that the review
cycle for the application is complete, but that the application is
not ready for approval in its present form.
- The
Company will announce the timing for its resubmission after further
discussion with the FDA, which is expected to take place in May
2024.
SPN-820 – Novel first-in-class molecule that
increases mTORC1 mediated synaptic function for depression
- More
than half the number of planned patients have been enrolled in the
ongoing Phase IIb multi-center randomized double-blind
placebo-controlled parallel design study of SPN-820 in adults with
treatment-resistant depression. The study is examining efficacy and
safety of SPN-820 over a course of five weeks of treatment in
approximately 268 patients in up to 50 clinical sites. The primary
outcome measure is the change from baseline to end of treatment
period on the Montgomery-Asberg Depression Rating Scale (MADRS)
Total Score. Topline data from the Phase IIb trial is expected in
the first half of 2025.
- The
Company has initiated a Phase II open-label study in approximately
40 subjects with major depressive disorder (MDD). The primary
objective of the study is to assess efficacy in MDD, as well as
onset of efficacy.
SPN-817 – Novel first-in-class highly selective
AChE inhibitor for epilepsy
- The
Company will hold a conference call on Thursday, May 23, 2024 to
report on interim data from approximately 40 patients from the
open-label Phase IIa clinical study of SPN-817 for
treatment-resistant seizures (webcast details forthcoming). The
study is examining the safety and tolerability of SPN-817 as
adjunctive therapy in adult patients with treatment-resistant
seizures, as well as assessing efficacy. Topline results for the
full study are expected in the second half of 2024.
SPN-443 – Novel stimulant for ADHD/CNS
- The
Company plans to initiate a Phase I single dose study in healthy
adults in 2024 following submission of an Investigational New Drug
application. The primary objective of the study is to assess safety
and tolerability.
First Quarter 2024 Financial
Results
This section includes information on non-GAAP
financial measures. See “Non-GAAP Financial Information” section
for information on non-GAAP financial measures. In addition, a
reconciliation of applicable GAAP to non-GAAP financial
information is included at the end of this press release.
Revenues
The following table provides information
regarding total revenues (dollars in millions):
|
Three Months EndedMarch 31, |
|
|
2024 |
|
2023 |
|
Change % |
Net
product sales |
|
|
|
|
|
Qelbree |
$ |
45.1 |
|
$ |
25.8 |
|
75 |
% |
Oxtellar XR |
|
26.9 |
|
|
28.9 |
|
(7 |
)% |
GOCOVRI® |
|
26.5 |
|
|
26.0 |
|
2 |
% |
APOKYN® |
|
16.7 |
|
|
17.2 |
|
(3 |
)% |
Trokendi XR |
|
16.0 |
|
|
34.8 |
|
(54 |
)% |
Other(2) |
|
7.2 |
|
|
7.9 |
|
(9 |
)% |
Total
net product sales |
|
138.4 |
|
|
140.6 |
|
(2 |
)% |
Royalty
and licensing revenues(3) |
|
5.2 |
|
|
13.2 |
|
(61 |
)% |
Total
revenues |
$ |
143.6 |
|
$ |
153.8 |
|
(7 |
)% |
|
|
|
|
|
|
Total
revenues excluding Trokendi XR and Oxtellar XR net product sales
(non-GAAP)(1) |
$ |
100.7 |
|
$ |
90.1 |
|
12 |
% |
- Total
revenues were $143.6 million, compared to $153.8 million in the
same period in 2023.
- Total
net product sales were $138.4 million, compared to $140.6 million
in the same period in 2023. The decrease was primarily due to the
decline in net sales of Trokendi XR offset by an increase in net
sales of Qelbree.
- Total
revenues excluding Trokendi XR and Oxtellar XR net product sales
(non-GAAP) increased 12% compared to the same period in 2023.
Other Financial Highlights
-
Operating loss was $(3.2) million compared to operating earnings of
$5.2 million in the same period in 2023. The decrease was primarily
due to lower royalty revenue.
- Adjusted
operating earnings (non-GAAP) were $22.3 million compared to $30.5
million in the same period in 2023.
- Net
earnings and diluted earnings per share were $0.1 million and
$0.00, respectively, compared to $16.9 million and $0.29,
respectively, in the same period in 2023.
- At March
31, 2024, cash, cash equivalents, and current and long-term
marketable securities were approximately $309.4 million compared to
$271.5 million as of December 31, 2023. This increase was primarily
due to cash generated from operations.
Full Year 2024 Financial
Guidance
For the full year 2024, the Company reiterates
its full year 2024 financial guidance as set forth below (dollars
in millions).
|
Amount(as of February 27,
2024) |
Total revenues (includes
approximately $125 - $135 million of Trokendi XR and Oxtellar
XR)(4)(5) |
$580 - $620 |
Combined R&D and SG&A
expenses |
$430 - $460 |
Operating loss(6) |
$(30) - $(0) |
Adjusted operating earnings
(non-GAAP)(1) |
$80 - $110 |
Non-GAAP Financial
Information
This press release contains financial measures
that present financial information which do not comply with United
States generally accepted accounting principles (GAAP). The
non-GAAP financial measures should be considered in addition to,
not as a substitute for or in isolation from, or superior to
measures prepared in accordance with GAAP. Non-GAAP adjusted
operating earnings adjusts for non-cash share-based compensation
expense, depreciation and amortization, intangible asset impairment
charges and changes to fair value of contingent consideration, and
for factors that are unusual, non-recurring or unpredictable, and
excludes those costs, expenses, and other specified items presented
in the reconciliation tables in this press release. In addition to
non-GAAP adjusted operating earnings, we also present total
revenues excluding net product sales of Trokendi XR (GAAP) and
Oxtellar XR (GAAP), which is a non-GAAP measure and is calculated
as total revenues (GAAP) less net product sales of Trokendi XR
(GAAP) and Oxtellar XR (GAAP). Beginning in the year a product
loses exclusivity due to generic entrants we generally do not
expect net product sales of such products to constitute a
significant part of our revenue in the future. We believe that the
use of non-GAAP financial measures provides useful supplemental
information to management, investors, analysts and others regarding
the Company’s revenue and results of operations and assist
management, investors, analysts, and others in understanding and
evaluating our revenue growth and the performance of the
business.
There are limitations associated with the use of
non-GAAP financial measures and therefore comparability may be
limited. These limitations include: non-GAAP financial measures
that may not be entirely comparable to similarly titled measures
used by other companies; these may not reflect all items of income
and expense, as applicable, that affect our operations; there may
be potential differences among calculation methodologies; these may
differ from the non-GAAP information used by other companies,
including peer companies. We mitigate these limitations by
reconciling the non-GAAP financial measure to the most comparable
GAAP financial measure. Investors are encouraged to review the
reconciliation. The Company’s 2024 financial guidance is also being
provided on both a GAAP and a non-GAAP basis.
(1) See the section titled “Non-GAAP Financial
Information” for information about this non-GAAP financial measure.
A reconciliation of each non-GAAP financial measure to the most
directly comparable GAAP financial measure is included at the end
of this press release.(2) Includes net product sales of MYOBLOC®,
XADAGO® and Osmolex ER®.(3) Royalty and licensing revenues include
royalties on generic Trokendi XR, other licensed products and
intellectual property.(4) Includes net product sales and royalty
and licensing revenue.(5) Reflects continued generic erosion of
Trokendi XR and generic erosion of Oxtellar XR beginning in
September 2024.(6) Includes amortization of intangible assets and
contingent consideration expense (gain).
Conference Call Details
Supernus will host a conference call and webcast
today, May 8, 2024, at 4:30 p.m. Eastern Time to discuss these
results.
A live webcast will be available in the Events
& Presentations section of the Company’s Investor Relations
website www.supernus.com/investors.
Participants may also pre-register any time
before the call here. Once registration is completed, participants
will be provided a dial-in number with a personalized conference
code to access the call. Please dial in 15 minutes prior to the
start time.
Following the live call, a replay will be
available on the Company's Investor Relations website
www.supernus.com/investors. The webcast will be available on the
Company’s website for 60 days following the live call.
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 (PD), cervical dystonia, chronic sialorrhea,
dyskinesia in PD patients receiving levodopa-based therapy, and
drug-induced extrapyramidal reactions in adult patients. We are
developing a broad range of novel CNS product candidates including
new potential treatments for hypomobility in PD, epilepsy,
depression, and other 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 expenditures; the Company’s ability to
increase the number of prescriptions written for each of its
products and the products of its subsidiaries; the Company’s
ability to increase its net revenue; the Company’s ability to
commercialize its products and the products of its subsidiaries;
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 the intellectual property of its
subsidiaries 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; the Company’s
ability to increase the number of prescriptions written for each of
its products and the products of its subsidiaries; the Company’s
ability to increase its net revenue from its products and the
products of its subsidiaries; 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, |
|
December 31, |
|
|
2024 |
|
|
|
2023 |
|
|
(unaudited) |
|
|
Assets |
|
|
|
Current
assets |
|
|
|
Cash and cash equivalents |
$ |
63,401 |
|
|
$ |
75,054 |
|
Marketable securities |
|
234,335 |
|
|
|
179,820 |
|
Accounts receivable, net |
|
147,734 |
|
|
|
144,155 |
|
Inventories, net |
|
75,079 |
|
|
|
77,408 |
|
Prepaid expenses and other current assets |
|
23,772 |
|
|
|
16,676 |
|
Total current assets |
|
544,321 |
|
|
|
493,113 |
|
Long-term marketable securities |
|
11,662 |
|
|
|
16,617 |
|
Property and equipment, net |
|
12,969 |
|
|
|
13,530 |
|
Intangible assets, net |
|
579,752 |
|
|
|
599,889 |
|
Goodwill |
|
117,019 |
|
|
|
117,019 |
|
Other assets |
|
38,367 |
|
|
|
37,505 |
|
Total assets |
$ |
1,304,090 |
|
|
$ |
1,277,673 |
|
|
|
|
|
Liabilities and stockholders’ equity |
|
|
|
Current
liabilities |
|
|
|
Accounts payable and accrued liabilities |
$ |
86,402 |
|
|
$ |
79,569 |
|
Accrued product returns and rebates |
|
167,226 |
|
|
|
154,274 |
|
Contingent consideration, current portion |
|
51,379 |
|
|
|
52,070 |
|
Other current liabilities |
|
9,547 |
|
|
|
4,283 |
|
Total current liabilities |
|
314,554 |
|
|
|
290,196 |
|
Contingent consideration, long term |
|
976 |
|
|
|
1,380 |
|
Operating lease liabilities, long term |
|
32,994 |
|
|
|
33,196 |
|
Deferred income tax liabilities, net |
|
19,501 |
|
|
|
24,963 |
|
Other liabilities |
|
6,899 |
|
|
|
6,422 |
|
Total liabilities |
|
374,924 |
|
|
|
356,157 |
|
|
|
|
|
Stockholders’ equity |
|
|
|
Common stock, $0.001 par value; 130,000,000 shares authorized;
54,965,316 and 54,723,356 shares issued and outstanding as of March
31, 2024 and December 31, 2023, respectively |
|
55 |
|
|
|
55 |
|
Additional paid-in capital |
|
446,960 |
|
|
|
439,493 |
|
Accumulated other comprehensive (loss) earnings, net of tax |
|
(534 |
) |
|
|
(593 |
) |
Retained earnings |
|
482,685 |
|
|
|
482,561 |
|
Total stockholders’ equity |
|
929,166 |
|
|
|
921,516 |
|
|
|
|
|
Total liabilities and stockholders’ equity |
$ |
1,304,090 |
|
|
$ |
1,277,673 |
|
Supernus Pharmaceuticals, Inc.Condensed
Consolidated Statements of Earnings(in thousands, except
share and per share data) |
|
Three Months EndedMarch 31, |
|
|
2024 |
|
|
|
2023 |
|
|
(unaudited) |
Revenues |
|
|
|
Net product sales |
$ |
138,461 |
|
|
$ |
140,575 |
|
Royalty and licensing revenues |
|
5,183 |
|
|
|
13,189 |
|
Total revenues |
|
143,644 |
|
|
|
153,764 |
|
|
|
|
|
Costs and expenses |
|
|
|
Cost of goods sold(a) |
|
16,309 |
|
|
|
23,460 |
|
Research and development |
|
24,930 |
|
|
|
21,212 |
|
Selling, general and administrative |
|
86,516 |
|
|
|
85,597 |
|
Amortization of intangible assets |
|
20,137 |
|
|
|
19,966 |
|
Contingent consideration gain |
|
(1,095 |
) |
|
|
(1,647 |
) |
Total costs and expenses |
|
146,797 |
|
|
|
148,588 |
|
|
|
|
|
Operating earnings (loss) |
|
(3,153 |
) |
|
|
5,176 |
|
|
|
|
|
Other income (expense) |
|
|
|
Interest and other income, net |
|
3,396 |
|
|
|
5,346 |
|
Interest expense |
|
— |
|
|
|
(1,505 |
) |
Total other income
(expense) |
|
3,396 |
|
|
|
3,841 |
|
|
|
|
|
Earnings before income
taxes |
|
243 |
|
|
|
9,017 |
|
|
|
|
|
Income tax expense
(benefit) |
|
119 |
|
|
|
(7,931 |
) |
Net earnings |
$ |
124 |
|
|
$ |
16,948 |
|
|
|
|
|
Earnings per share |
|
|
|
Basic |
$ |
0.00 |
|
|
$ |
0.31 |
|
Diluted |
$ |
0.00 |
|
|
$ |
0.29 |
|
|
|
|
|
Weighted average shares
outstanding |
|
|
|
Basic |
|
54,801,748 |
|
|
|
54,380,947 |
|
Diluted |
|
55,626,663 |
|
|
|
62,454,204 |
|
(a) Excludes amortization of intangible
assets.
Supernus Pharmaceuticals,
Inc.Reconciliations of GAAP to Non-GAAP Financial
Information(Unaudited)
Reconciliation of GAAP Total revenues to
Non-GAAP Total revenues excluding Trokendi XR and Oxtellar XR net
product sales
An itemized reconciliation between total
revenues on a GAAP basis and Total revenues excluding Trokendi XR
and Oxtellar XR net product sales, a non-GAAP measure, is as
follows (unaudited, dollars in millions):
|
Three Months EndedMarch 31, |
|
|
|
|
2024 |
|
|
|
2023 |
|
|
Change % |
Total revenues (GAAP)(1) |
$ |
143.6 |
|
|
$ |
153.8 |
|
|
(7 |
)% |
Adjustments: |
|
|
|
|
|
Trokendi XR net product sales |
|
(16.0 |
) |
|
|
(34.8 |
) |
|
(54 |
)% |
Oxtellar XR net product sales |
|
(26.9 |
) |
|
|
(28.9 |
) |
|
(7 |
)% |
Total revenues excluding
Trokendi XR and Oxtellar XR net product sales (non-GAAP)(1) |
$ |
100.7 |
|
|
$ |
90.1 |
|
|
12 |
% |
(1) Includes net product sales and royalty and
licensing revenues.
Reconciliation of GAAP Operating earnings (loss)
to Non-GAAP Adjusted Operating earnings
An itemized reconciliation between operating
earnings (loss) on a GAAP basis and adjusted operating earnings on
a non-GAAP basis is as follows (dollars in millions):
|
Three Months EndedMarch 31, |
|
|
2024 |
|
|
|
2023 |
|
Operating earnings
(loss) - As Reported (GAAP) |
$ |
(3.2 |
) |
|
$ |
5.2 |
|
Adjustments: |
|
|
|
Amortization of intangible assets |
|
20.1 |
|
|
|
20.0 |
|
Share-based compensation |
|
5.9 |
|
|
|
6.3 |
|
Contingent consideration |
|
(1.1 |
) |
|
|
(1.6 |
) |
Depreciation |
|
0.6 |
|
|
|
0.6 |
|
Operating earnings -
As Adjusted (non-GAAP) |
$ |
22.3 |
|
|
$ |
30.5 |
|
Non-GAAP adjusted operating earnings adjusts for
non-cash items including amortization of intangible assets,
share-based compensation expense, change in fair value of
contingent consideration, and depreciation.
Reconciliation of Full Year 2024 Financial
Guidance - GAAP Operating earnings (loss) to Non-GAAP Adjusted
Operating earnings (loss)
An itemized reconciliation between projected
operating earnings (loss) on a GAAP basis and projected adjusted
operating earnings on a non-GAAP basis is as follows (dollars in
millions):
|
Amount(as of February 27,
2024) |
Operating earnings
(loss) - GAAP |
$(30) - $0 |
Adjustments: |
|
Amortization of intangible assets |
$80 - $81 |
Share-based compensation |
$27 - $29 |
Contingent consideration |
$1 - $2 |
Depreciation |
$2 - $3 |
Operating earnings -
As Adjusted (non-GAAP) |
$80 - $110 |
CONTACTS:
Jack A. Khattar, President and CEOTimothy C.
Dec, Senior Vice President and CFOSupernus Pharmaceuticals,
Inc.(301) 838-2591
or
INVESTOR CONTACT:Peter VozzoICR Westwicke(443)
213-0505peter.vozzo@westwicke.com
Supernus Pharmaceuticals (NASDAQ:SUPN)
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