- Q2 2023 total revenues were $46.1
million
- Total revenues in the first six months of 2023 were
$108.6 million
- Vanda provides update on pipeline advancements and
regulatory plans
WASHINGTON, July 27,
2023 /PRNewswire/ -- Vanda Pharmaceuticals Inc.
(Vanda) (Nasdaq: VNDA) today announced financial and operational
results for the second quarter ended June
30, 2023.
"During the second quarter we continued our efforts to protect
our commercial interests in the HETLIOZ® franchise in
the face of the at-risk generic launch. We recorded a higher number
of HETLIOZ® prescription dispenses in the second quarter
of 2023 as compared to the first quarter of 2023, a testament to
our dedication to our patient services and the loyalty of our
patients," said Mihael H.
Polymeropoulos, M.D., Vanda's President, CEO and Chairman of
the Board. "We also advanced towards our goal of marketing
authorizations for Fanapt® in bipolar disorder,
HETLIOZ® in insomnia and tradipitant in patients with
gastroparesis."
Financial Highlights
Second Quarter of 2023
- Total net product sales from HETLIOZ® and
Fanapt® were $46.1 million
in the second quarter of 2023, a 28% decrease compared to
$64.4 million in the second quarter
of 2022.
- HETLIOZ® net product sales were $22.0 million in the second quarter of 2023, a
47% decrease compared to $41.2
million in the second quarter of 2022. The decrease was the
result of the at-risk launch of a generic version of
HETLIOZ® in the U.S.
- Fanapt® net product sales were $24.1 million in the second quarter of 2023, a 4%
increase compared to $23.2 million in
the second quarter of 2022.
- Net income was $1.5 million in
the second quarter of 2023 compared to net income of $2.6 million in the second quarter of 2022.
- Cash, cash equivalents and marketable securities (Cash) was
$489.4 million as of June 30, 2023, representing a decrease to Cash of
$12.1 million, or 2%, compared to
March 31, 2023.
First Six Months of 2023
- Total net product sales from HETLIOZ® and
Fanapt® were $108.6
million in the first six months of 2023, a 13% decrease
compared to $124.6 million in the
first six months of 2022.
- HETLIOZ® net product sales were $61.6 million in the first six months of 2023, a
21% decrease compared to $78.2
million in the first six months of 2022. The decrease was
the result of the at-risk launch of a generic version of
HETLIOZ® in the U.S.
- Fanapt® net product sales were $47.0 million in the first six months of 2023, a
1% increase compared to $46.4 million
in the first six months of 2022.
- Net income was $4.8 million in
the first six months of 2023 compared to a net loss of $3.9 million in the first six months of
2022.
- Cash, cash equivalents and marketable securities (Cash) was
$489.4 million as of June 30, 2023, representing an increase to Cash
of $48.5 million, or 11%, compared to
June 30, 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
continues to pursue U.S. Food and Drug Administration (FDA)
approval of a supplemental New Drug Application (sNDA) for
Fanapt® in bipolar I disorder.
HETLIOZ® (tasimelteon)
- Vanda is continuing to pursue FDA approvals for
HETLIOZ® in the indications of insomnia and jet lag
disorder.
- In May 2023, the U.S. Court of
Appeals for the Federal Circuit (the Federal Circuit) affirmed the
lower court ruling in favor of Teva Pharmaceuticals USA, Inc. (Teva), Apotex Inc. and Apotex Corp.
(Apotex) in the HETLIOZ® Abbreviated New Drug
Applications litigation. Vanda disagrees with the Federal Circuit's
ruling, and in June 2023, Vanda
requested a rehearing from the Federal Circuit. On July 18, 2023, the Federal Circuit requested a
response from Teva and Apotex, which is due August 1, 2023.
Tradipitant
- Vanda continues to pursue FDA approval of a New Drug
Application (NDA) for tradipitant for patients with
gastroparesis.
- Vanda announced positive results in the Phase III study of
tradipitant in motion sickness. Vanda plans to continue the motion
sickness clinical program and pursue FDA approval upon completion
of additional efficacy and safety studies.
Early-Stage Programs
- Vanda announced that the FDA had granted Orphan Drug
Designation for VCA-894A for the treatment of Charcot-Marie-Tooth
disease, axonal, type 2S (CMT2S), caused by cryptic splice site
variants within IGHMBP2.
GAAP Financial Results
Net income was $1.5 million in the
second quarter of 2023 compared to net income of $2.6 million in the second quarter of
2022. Diluted net income per share was $0.03 in the second quarter of 2023 compared to
diluted net income per share of $0.05
in the second quarter of 2022.
Net income was $4.8 million in the
first six months of 2023 compared to a net loss of $3.9 million in the first six months of 2022.
Diluted net income per share was $0.08 in the first six months of 2023 compared to
diluted net loss per share of $0.07
in the first six months 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, Thursday, July 27, 2023, at 4:30 PM ET. During the call, Vanda's management
will discuss the second 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 4063687.
A replay of the call will be available on Thursday, July 27, 2023, beginning at
8:30 PM ET and will be accessible
until Thursday, August 3, 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 4063687.
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 FDA
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 and 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 pursue and obtain FDA approval of the sNDAs for
Fanapt® and HETLIOZ® and the NDA for
tradipitant, the FDA's assessment of the sufficiency of the data
packages to be included in Vanda's regulatory submissions for
Fanapt®, HETLIOZ® and tradipitant, Vanda's
ability to complete the clinical program for tradipitant in the
treatment of motion sickness, the outcome of Vanda's request for a
rehearing by 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
|
|
Six Months
Ended
|
|
June 30
2023
|
|
June 30
2022
|
|
June 30
2023
|
|
June 30
2022
|
Revenues:
|
|
|
|
|
|
|
|
HETLIOZ® net product sales
|
$
21,979
|
|
$
41,188
|
|
$
61,595
|
|
$
78,219
|
Fanapt® net product sales
|
24,077
|
|
23,202
|
|
46,959
|
|
46,363
|
Total
revenues
|
46,056
|
|
64,390
|
|
108,554
|
|
124,582
|
Operating
expenses:
|
|
|
|
|
|
|
|
Cost of goods sold
excluding amortization
|
3,499
|
|
6,059
|
|
8,273
|
|
11,724
|
Research and
development
|
16,647
|
|
21,490
|
|
35,884
|
|
42,459
|
Selling, general and
administrative
|
28,399
|
|
33,001
|
|
64,503
|
|
73,849
|
Intangible asset
amortization
|
378
|
|
379
|
|
757
|
|
758
|
Total operating
expenses
|
48,923
|
|
60,929
|
|
109,417
|
|
128,790
|
Income (loss) from
operations
|
(2,867)
|
|
3,461
|
|
(863)
|
|
(4,208)
|
Other
income
|
5,459
|
|
329
|
|
8,983
|
|
434
|
Income (loss) before
income taxes
|
2,592
|
|
3,790
|
|
8,120
|
|
(3,774)
|
Provision for income
taxes
|
1,072
|
|
1,216
|
|
3,348
|
|
82
|
Net income
(loss)
|
$
1,520
|
|
$
2,574
|
|
$
4,772
|
|
$
(3,856)
|
Net income (loss) per
share, basic
|
$
0.03
|
|
$
0.05
|
|
$
0.08
|
|
$
(0.07)
|
Net income (loss) per
share, diluted
|
$
0.03
|
|
$
0.05
|
|
$
0.08
|
|
$
(0.07)
|
Weighted average shares
outstanding, basic
|
57,453,916
|
|
56,508,533
|
|
57,233,878
|
|
56,307,999
|
Weighted average shares
outstanding, diluted
|
57,535,615
|
|
56,821,024
|
|
57,469,105
|
|
56,307,999
|
VANDA PHARMACEUTICALS INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS
(in
thousands)
(unaudited)
|
|
|
June 30
2023
|
|
December 31
2022
|
ASSETS
|
|
|
|
Current
assets:
|
|
|
|
Cash and cash
equivalents
|
$
150,031
|
|
$
135,029
|
Marketable
securities
|
339,320
|
|
331,830
|
Accounts receivable,
net
|
33,621
|
|
33,512
|
Inventory
|
1,080
|
|
1,194
|
Prepaid expenses and
other current assets
|
9,452
|
|
17,727
|
Total current
assets
|
533,504
|
|
519,292
|
Property and equipment,
net
|
2,164
|
|
2,573
|
Operating lease
right-of-use assets
|
7,782
|
|
8,400
|
Intangible assets,
net
|
17,808
|
|
18,565
|
Deferred tax
assets
|
70,476
|
|
74,039
|
Non-current inventory
and other
|
9,948
|
|
11,378
|
Total
assets
|
$
641,682
|
|
$
634,247
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
Current
liabilities:
|
|
|
|
Accounts payable and
accrued liabilities
|
$
31,929
|
|
$
45,551
|
Product revenue
allowances
|
55,468
|
|
45,885
|
Total current
liabilities
|
87,397
|
|
91,436
|
Operating lease
non-current liabilities
|
7,942
|
|
8,813
|
Other non-current
liabilities
|
6,445
|
|
6,800
|
Total
liabilities
|
101,784
|
|
107,049
|
Stockholders'
equity:
|
|
|
|
Common
stock
|
57
|
|
57
|
Additional paid-in
capital
|
693,835
|
|
686,235
|
Accumulated other
comprehensive loss
|
(865)
|
|
(1,193)
|
Accumulated
deficit
|
(153,129)
|
|
(157,901)
|
Total stockholders'
equity
|
539,898
|
|
527,198
|
Total liabilities and
stockholders' equity
|
$
641,682
|
|
$
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.