- Q4 2022 total revenues were $64.5
million
- Full year 2022 revenues were $254.4
million
- Vanda provides update on pipeline advancements and upcoming
milestones
WASHINGTON, Feb. 8, 2023
/PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA)
today announced financial and operational results for the fourth
quarter and full year ended December 31,
2022.
"Our strong full year 2022 commercial performance positions
Vanda well towards our objectives as we pursue a number of near
term regulatory filings in bipolar I disorder, gastroparesis and
insomnia," said Mihael H.
Polymeropoulos, M.D., Vanda's President, CEO and Chairman of
the Board. "At the same time, we continue to believe in the
strength of our intellectual property portfolio as we proceed with
our appeal in the HETLIOZ patent litigation."
Financial Highlights
Fourth Quarter of 2022
- Total net product sales from HETLIOZ® and
Fanapt® were $64.5 million
in the fourth quarter of 2022, a 5% decrease compared to
$68.0 million in the fourth quarter
of 2021.
- HETLIOZ® net product sales were $40.1 million in the fourth quarter of 2022, a 9%
decrease compared to $44.1 million in
the fourth quarter of 2021, due in part to continued reimbursement
challenges for prescriptions for patients with Non-24-Hour
Sleep-Wake Disorder (Non-24).
- Fanapt® net product sales were $24.4 million in the fourth quarter of 2022, a 2%
increase compared to $24.0 million in
the fourth quarter of 2021.
- Net income was $6.9 million in
the fourth quarter of 2022 compared to $7.1
million in the fourth quarter of 2021.
- Cash, cash equivalents and marketable securities (Cash) was
$466.9 million as of December 31, 2022, representing an increase to
Cash of $12.1 million, or 3%,
compared to September 30, 2022.
Full Year 2022
- Total net product sales from HETLIOZ® and
Fanapt® were $254.4
million for the full year 2022, a 5% decrease compared to
$268.7 million for the full year
2021.
- HETLIOZ® net product sales were $159.7 million for the full year 2022, an 8%
decrease compared to $173.5 million
for the full year 2021, due in part to continued reimbursement
challenges for prescriptions for patients with Non-24.
- Fanapt® net product sales were $94.7 million for the full year 2022, essentially
flat compared to $95.1 million for
the full year 2021.
- Net income was $6.3 million for
the full year 2022 compared to net income of $33.2 million for the full year 2021.
- Cash, cash equivalents and marketable securities (Cash) was
$466.9 million as of December 31, 2022, representing an increase to
Cash of $34.0 million, or 8%,
compared to December 31, 2021.
Key Operational Highlights
HETLIOZ® (tasimelteon)
- Vanda is continuing to pursue regulatory approvals for
HETLIOZ® in the indications of insomnia and jet lag
disorder.
- In December 2022, the U.S.
District Court for the District of Delaware delivered its decision for the
consolidated HETLIOZ® patent lawsuit against defendants
Teva Pharmaceuticals USA, Inc.
(Teva) and Apotex Inc. and Apotex Corp. (Apotex), ruling in favor
of the defendants. Vanda filed an appeal to the U.S. Court of
Appeals for the Federal Circuit where an oral argument is scheduled
for March 14, 2023. Despite the
pending appeal, Teva has launched at risk its generic version of
HETLIOZ® in the U.S.
- In December 2022, Vanda filed
patent infringement lawsuits against each of Teva and Apotex in the
U.S. District Court for the District of New Jersey asserting that Teva and Apotex's
generic versions of HETLIOZ® infringe U.S. Patent No.
11,285,129.
Tradipitant
- Vanda is continuing to conduct an open-label safety study for
tradipitant in gastroparesis and approximately the first 400
patients enrolled in the study were locked in preparation for the
Company's planned New Drug Application (NDA) submission. The study
continues to enroll open label patients and Vanda continues to
receive requests from patients seeking access to tradipitant
through the Expanded Access program, which has multiple patients
who have taken tradipitant for more than one year.
- Vanda is preparing for the submission of an NDA for tradipitant
for patients with gastroparesis. Vanda expects to submit this NDA
to the FDA in the first half of 2023.
- The Phase III study of tradipitant in the treatment of motion
sickness is over 75% enrolled. Results are expected by
mid-2023.
Fanapt® (iloperidone)
- In December 2022, Vanda 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 plans to submit a
supplemental New Drug Application (sNDA) in the first half of
2023.
Early-Stage Programs
- In December 2022, Vanda announced
results in a Phase II clinical study of VQW-765 in the treatment of
acute performance anxiety in social situations. This is the first
time that an alpha 7 nicotinic acetylcholine receptor (α7-nAChR)
partial agonist has shown efficacy in a clinical study of
performance anxiety.
GAAP Financial Results
Net income was $6.9 million in the
fourth quarter of 2022 compared to net income of $7.1 million in the fourth quarter of
2021. Diluted net income per share was $0.12 in the fourth quarter of 2022 compared to
diluted net income per share of $0.12
in the fourth quarter of 2021.
Net income was $6.3 million for
the full year 2022 compared to net income of $33.2 million for the full year 2021. Diluted net
income per share was $0.11 for the
full year 2022 compared to diluted net income per share of
$0.58 for the full year 2021.
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, 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.
Conference Call
Vanda has scheduled a conference call for today, Wednesday, February 8, 2023, at 4:30 PM ET. During the call, Vanda's management
will discuss the fourth quarter and full year 2022 financial
results and other corporate activities. Investors can call
1-800-715-9871 (domestic) or 1-646-307-1963 (international)
and use passcode number 4734670. A replay of the call will be
available on Wednesday, February 8,
2023, beginning at 8:30 PM ET
and will be accessible until Wednesday,
February 15, 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 4734670.
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 HETLIOZ® in the treatments of
insomnia and jet lag disorder, tradipitant in the treatment of
patients with gastroparesis and Fanapt® in the treatment
of bipolar I in adults and the clinical development timeline for
tradipitant in the treatment of motion sickness 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 complete and
submit the NDA for tradipitant and the sNDAs for
HETLIOZ® and Fanapt® in the specified
timeframes, the FDA's assessment of the sufficiency of the data
packages to be included in Vanda's planned NDA submission for
tradipitant and sNDA submissions for HETLIOZ® and
Fanapt®, and Vanda's ability to complete the Phase III
clinical study of tradipitant in the treatment of motion sickness
by mid-2023. 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
|
|
Twelve Months
Ended
|
|
December 31
2022
|
|
December 31
2021
|
|
December 31
2022
|
|
December 31
2021
|
Revenues:
|
|
|
|
|
|
|
|
HETLIOZ® net product sales
|
$
40,101
|
|
$
44,069
|
|
$
159,655
|
|
$
173,536
|
Fanapt® net product sales
|
24,381
|
|
23,950
|
|
94,727
|
|
95,146
|
Total
revenues
|
64,482
|
|
68,019
|
|
254,382
|
|
268,682
|
Operating
expenses:
|
|
|
|
|
|
|
|
Cost of goods sold
excluding amortization
|
6,238
|
|
6,236
|
|
24,282
|
|
25,629
|
Research and
development
|
18,454
|
|
19,331
|
|
85,770
|
|
75,363
|
Selling, general and
administrative
|
32,782
|
|
33,447
|
|
136,485
|
|
124,047
|
Intangible asset
amortization
|
379
|
|
369
|
|
1,516
|
|
1,478
|
Total operating
expenses
|
57,853
|
|
59,383
|
|
248,053
|
|
226,517
|
Income from
operations
|
6,629
|
|
8,636
|
|
6,329
|
|
42,165
|
Other income
(expense)
|
2,984
|
|
(26)
|
|
4,971
|
|
199
|
Income before income
taxes
|
9,613
|
|
8,610
|
|
11,300
|
|
42,364
|
Provision for income
taxes
|
2,752
|
|
1,532
|
|
5,025
|
|
9,212
|
Net income
|
$
6,861
|
|
$
7,078
|
|
$
6,275
|
|
$
33,152
|
Net income per share,
basic
|
$
0.12
|
|
$
0.13
|
|
$
0.11
|
|
$
0.60
|
Net income per share,
diluted
|
$
0.12
|
|
$
0.12
|
|
$
0.11
|
|
$
0.58
|
Weighted average shares
outstanding, basic
|
56,651,984
|
|
55,787,252
|
|
56,461,877
|
|
55,548,122
|
Weighted average shares
outstanding, diluted
|
57,188,551
|
|
57,229,805
|
|
56,983,171
|
|
56,921,836
|
VANDA
PHARMACEUTICALS INC. CONDENSED CONSOLIDATED BALANCE
SHEETS (in
thousands) (unaudited)
|
|
|
December 31
2022
|
|
December 31
2021
|
ASSETS
|
|
|
|
Current
assets:
|
|
|
|
Cash and cash
equivalents
|
$
135,029
|
|
$
52,071
|
Marketable
securities
|
331,830
|
|
380,742
|
Accounts receivable,
net
|
33,512
|
|
32,467
|
Inventory
|
1,194
|
|
1,025
|
Prepaid expenses and
other current assets
|
17,727
|
|
11,996
|
Total current
assets
|
519,292
|
|
478,301
|
Property and equipment,
net
|
2,573
|
|
3,113
|
Operating lease
right-of-use assets
|
8,400
|
|
9,272
|
Intangible assets,
net
|
18,565
|
|
20,081
|
Deferred tax
assets
|
74,039
|
|
74,878
|
Non-current inventory
and other
|
11,378
|
|
8,147
|
Total
assets
|
$
634,247
|
|
$
593,792
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
Current
liabilities:
|
|
|
|
Accounts payable and
accrued liabilities
|
$
45,551
|
|
$
34,438
|
Product revenue
allowances
|
45,885
|
|
39,981
|
Total current
liabilities
|
91,436
|
|
74,419
|
Operating lease
non-current liabilities
|
8,813
|
|
10,055
|
Other non-current
liabilities
|
6,800
|
|
4,390
|
Total
liabilities
|
107,049
|
|
88,864
|
Stockholders'
equity:
|
|
|
|
Common
stock
|
57
|
|
56
|
Additional paid-in
capital
|
686,235
|
|
669,223
|
Accumulated other
comprehensive loss
|
(1,193)
|
|
(175)
|
Accumulated
deficit
|
(157,901)
|
|
(164,176)
|
Total stockholders'
equity
|
527,198
|
|
504,928
|
Total liabilities and
stockholders' equity
|
$
634,247
|
|
$
593,792
|
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.