- Q1 2023 total revenues were $62.5
million
- Vanda provides update on three upcoming regulatory
submissions
WASHINGTON, May 3, 2023
/PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA)
today announced financial and operational results for the first
quarter ended March 31, 2023.
"The first quarter of 2023 was busy and challenging as we are
preparing three regulatory submissions for bipolar disorder,
insomnia and gastroparesis and, at the same time, defending our
intellectual property," said Mihael H.
Polymeropoulos, M.D., Vanda's President, CEO and Chairman of
the Board.
Financial Highlights
- Total net product sales from HETLIOZ® and
Fanapt® were $62.5 million
in the first quarter of 2023, a 4% increase compared to
$60.2 million in the first quarter of
2022.
- HETLIOZ® net product sales were $39.6 million in the first quarter of 2023, a 7%
increase compared to $37.0 million in
the first quarter of 2022. Net product sales for the first quarter
of 2023 reflect significant inventory stocking at specialty
pharmacy customers as compared to prior periods related to the
at-risk launch of a generic version of HETLIOZ® in the
U.S.
- Fanapt® net product sales were $22.9 million in the first quarter of 2023, a 1%
decrease compared to $23.2 million in
the first quarter of 2022.
- Net income was $3.3 million in
the first quarter of 2023 compared to a net loss of $6.4 million in the first quarter of 2022.
- Cash, cash equivalents and marketable securities (Cash) was
$501.5 million as of March 31, 2023, representing an increase to Cash
of $66.3 million, or 15%, compared to
March 31, 2022.
Key Operational Highlights
Fanapt® (iloperidone)
- Vanda previously announced positive results in the Phase
III clinical study of Fanapt® in acute manic and mixed
episodes associated with bipolar I disorder in adults. Vanda
expects to submit a supplemental New Drug Application (sNDA) in the
second quarter of 2023.
HETLIOZ® (tasimelteon)
- Vanda is continuing to pursue regulatory approvals for
HETLIOZ® in the indications of insomnia and jet lag
disorder.
- On March 14, 2023, the U.S. Court
of Appeals for the Federal Circuit (the Federal Circuit) held an
oral argument in relation to Vanda's appeal of the
HETLIOZ® Abbreviated New Drug Application litigation
ruling in favor of defendants Teva Pharmaceuticals USA, Inc., Apotex Inc. and Apotex Corp. Vanda
awaits the Federal Circuit's decision.
- In March 2023, Vanda announced
that it had prevailed against the U.S. Food and Drug Administration
(FDA) in a Freedom of Information Act lawsuit regarding certain
records relating to the FDA's denial of Vanda's sNDA for
HETLIOZ® in jet lag disorder.
Tradipitant
- Vanda is preparing for the submission of a New Drug Application
(NDA) for tradipitant for patients with gastroparesis. Vanda
expects to submit this NDA to the FDA in the second quarter of
2023.
- The Phase III study of tradipitant in the treatment of motion
sickness is fully enrolled. Results are expected by mid-2023.
GAAP Financial Results
Net income was $3.3 million in the
first quarter of 2023 compared to net loss of $6.4 million in the first quarter of
2022. Diluted net income per share was $0.06 in the first quarter of 2023 compared to
diluted net loss per share of $0.11
in the first quarter of 2022.
2023 Financial Guidance
Given uncertainties surrounding the U.S. market for
HETLIOZ® for the treatment of Non-24 as a result of the
ongoing HETLIOZ® patent litigation and the at-risk
launch of a generic version of HETLIOZ®, Vanda is unable
to provide 2023 financial guidance at this time. Vanda will
continue to evaluate its ability to provide financial guidance as
the year progresses.
HETLIOZ® net product sales will likely decline
in future periods, potentially significantly, related to the
at-risk launch of a generic version of HETLIOZ® in the
U.S.
Conference Call
Vanda has scheduled a conference call for today, Wednesday, May 3, 2023, at 4:30 PM ET. During the call, Vanda's management
will discuss the first quarter 2023 financial results and other
corporate activities. Investors can call 1-800-715-9871 (domestic)
or 1-646-307-1963 (international) and use passcode number 7072297.
A replay of the call will be available on Wednesday, May 3, 2023, beginning at 8:30 PM ET and will be accessible until
Wednesday, May 10, 2023 at
8:30 PM ET. The replay call-in number
is 1-800-770-2030 for domestic callers and 1-609-800-9909 for
international callers. The passcode number is 7072297.
The conference call will be broadcast simultaneously on Vanda's
website, www.vandapharma.com. Investors should click on the
Investors tab and are advised to go to the website at least 15
minutes early to register, download, and install any necessary
software or presentations. The call will also be archived on
Vanda's website for a period of 30 days.
About Vanda Pharmaceuticals Inc.
Vanda is a leading global biopharmaceutical company focused on
the development and commercialization of innovative therapies to
address high unmet medical needs and improve the lives of patients.
For more on Vanda Pharmaceuticals Inc., please visit
www.vandapharma.com and follow us on Twitter @vandapharma.
CAUTIONARY NOTE REGARDING FORWARD LOOKING STATEMENTS
Various statements in this press release, including, but not
limited to, statements regarding Vanda's plans for pursuit of
regulatory approval of Fanapt® in the treatment of
bipolar I in adults, HETLIOZ® in the treatments of
insomnia and jet lag disorder and tradipitant in the treatment of
patients with gastroparesis, the clinical development timeline for
tradipitant in the treatment of motion sickness and Vanda's
expectations regarding the impact of generic competition on the
HETLIOZ® business are "forward-looking statements" under
the securities laws. All statements other than statements of
historical fact are statements that could be deemed forward-looking
statements. Forward-looking statements are based upon current
expectations and assumptions that involve risks, changes in
circumstances and uncertainties. Important factors that could cause
actual results to differ materially from those reflected in Vanda's
forward-looking statements include, among others, Vanda's ability
to obtain regulatory approval for HETLIOZ® in the
indications of insomnia and jet lag disorder, Vanda's ability to
complete and submit the sNDA for Fanapt® and NDA for
tradipitant in the specified timeframes, the FDA's assessment of
the sufficiency of the data packages to be included in Vanda's
planned regulatory submissions for Fanapt®,
HETLIOZ® and tradipitant, Vanda's ability to complete
the Phase III clinical study of tradipitant in the treatment of
motion sickness by mid-2023, the outcome of Vanda's appeal in the
Federal Circuit and Vanda's ability to enforce its legal rights to
exclusivity for HETLIOZ®. Therefore, no assurance can be
given that the results or developments anticipated by Vanda will be
realized or, even if substantially realized, that they will have
the expected consequences to, or effects on, Vanda. Forward-looking
statements in this press release should be evaluated together with
the various risks and uncertainties that affect Vanda's business
and market, particularly those identified in the "Cautionary Note
Regarding Forward-Looking Statements", "Risk Factors" and
"Management's Discussion and Analysis of Financial Condition and
Results of Operations" sections of Vanda's most recent Annual
Report on Form 10-K, as updated by Vanda's subsequent Quarterly
Reports on Form 10-Q, Current Reports on Form 8-K and other filings
with the U.S. Securities and Exchange Commission, which are
available at www.sec.gov.
All written and verbal forward-looking statements attributable
to Vanda or any person acting on its behalf are expressly qualified
in their entirety by the cautionary statements contained or
referred to herein. Vanda cautions investors not to rely too
heavily on the forward-looking statements Vanda makes or that are
made on its behalf. The information in this press release is
provided only as of the date of this press release, and Vanda
undertakes no obligation, and specifically declines any obligation,
to update or revise publicly any forward-looking statements,
whether as a result of new information, future events or otherwise,
except as required by law.
VANDA
PHARMACEUTICALS INC.
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands,
except for share and per share amounts)
(unaudited)
|
|
|
Three Months
Ended
|
|
March 31
2023
|
|
March 31
2022
|
Revenues:
|
|
|
|
HETLIOZ® net product sales
|
$
39,616
|
|
$
37,031
|
Fanapt® net product sales
|
22,882
|
|
23,161
|
Total
revenues
|
62,498
|
|
60,192
|
Operating
expenses:
|
|
|
|
Cost of goods sold
excluding amortization
|
4,774
|
|
5,665
|
Research and
development
|
19,237
|
|
20,969
|
Selling, general and
administrative
|
36,104
|
|
40,848
|
Intangible asset
amortization
|
379
|
|
379
|
Total operating
expenses
|
60,494
|
|
67,861
|
Income (loss) from
operations
|
2,004
|
|
(7,669)
|
Other
income
|
3,524
|
|
105
|
Income (loss) before
income taxes
|
5,528
|
|
(7,564)
|
Provision (benefit)
for income taxes
|
2,276
|
|
(1,134)
|
Net income
(loss)
|
$
3,252
|
|
$
(6,430)
|
Net income (loss) per
share, basic
|
$
0.06
|
|
$
(0.11)
|
Net income (loss) per
share, diluted
|
$
0.06
|
|
$
(0.11)
|
Weighted average shares
outstanding, basic
|
57,011,396
|
|
56,105,239
|
Weighted average shares
outstanding, diluted
|
57,400,152
|
|
56,105,239
|
VANDA
PHARMACEUTICALS INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS
(in
thousands)
(unaudited)
|
|
|
March 31
2023
|
|
December 31
2022
|
ASSETS
|
|
|
|
Current
assets:
|
|
|
|
Cash and cash
equivalents
|
$
354,171
|
|
$
135,029
|
Marketable
securities
|
147,325
|
|
331,830
|
Accounts receivable,
net
|
24,513
|
|
33,512
|
Inventory
|
1,105
|
|
1,194
|
Prepaid expenses and
other current assets
|
6,593
|
|
17,727
|
Total current
assets
|
533,707
|
|
519,292
|
Property and equipment,
net
|
2,333
|
|
2,573
|
Operating lease
right-of-use assets
|
8,097
|
|
8,400
|
Intangible assets,
net
|
18,186
|
|
18,565
|
Deferred tax
assets
|
71,747
|
|
74,039
|
Non-current inventory
and other
|
10,462
|
|
11,378
|
Total
assets
|
$
644,532
|
|
$
634,247
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
Current
liabilities:
|
|
|
|
Accounts payable and
accrued liabilities
|
$
35,092
|
|
$
45,551
|
Product revenue
allowances
|
58,702
|
|
45,885
|
Total current
liabilities
|
93,794
|
|
91,436
|
Operating lease
non-current liabilities
|
8,387
|
|
8,813
|
Other non-current
liabilities
|
6,612
|
|
6,800
|
Total
liabilities
|
108,793
|
|
107,049
|
Stockholders'
equity:
|
|
|
|
Common
stock
|
57
|
|
57
|
Additional paid-in
capital
|
690,586
|
|
686,235
|
Accumulated other
comprehensive loss
|
(255)
|
|
(1,193)
|
Accumulated
deficit
|
(154,649)
|
|
(157,901)
|
Total stockholders'
equity
|
535,739
|
|
527,198
|
Total liabilities and
stockholders' equity
|
$
644,532
|
|
$
634,247
|
Corporate Contact:
Kevin Moran
Senior Vice President, Chief Financial Officer and Treasurer
Vanda Pharmaceuticals Inc.
202-734-3400
pr@vandapharma.com
Elizabeth Van Every
Head of Corporate Affairs
Vanda Pharmaceuticals Inc.
202-734-3400
pr@vandapharma.com
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SOURCE Vanda Pharmaceuticals Inc.