- Total revenues in the first nine months of 2023 were
$147.4 million
- Vanda provides update on pipeline advancements and
regulatory plans
WASHINGTON, Nov. 8, 2023 /PRNewswire/ -- Vanda
Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced
financial and operational results for the third quarter ended
September 30, 2023.
"We have significantly advanced our development pipeline, now
expecting FDA decisions on two sNDAs for bipolar I disorder and
insomnia with PDUFA dates in the first half of 2024. We are also
pleased with our revenue performance despite the challenges with
the at-risk launch of a generic Hetlioz product," said Mihael H. Polymeropoulos, M.D., Vanda's
President, CEO and Chairman of the Board. "We look forward to
increasing and diversifying our future revenue sources with new
products and new indications on existing products as well as with
external business development activities."
Financial Highlights
Third Quarter of 2023
- Total net product sales from HETLIOZ® and
Fanapt® were $38.8 million
in the third quarter of 2023, a 41% decrease compared to
$65.3 million in the third quarter of
2022.
- HETLIOZ® net product sales were $17.5 million in the third quarter of 2023, a 58%
decrease compared to $41.3 million in
the third 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 $21.3 million in the third quarter of 2023, an
11% decrease compared to $24.0
million in the third quarter of 2022.
- Net income was $0.1 million in
the third quarter of 2023 compared to net income of $3.3 million in the third quarter of 2022.
- Cash, cash equivalents and marketable securities (Cash) was
$489.9 million as of September 30, 2023, representing an increase to
Cash of $0.5 million compared to
June 30, 2023.
First Nine Months of 2023
- Total net product sales from HETLIOZ® and
Fanapt® were $147.4
million in the first nine months of 2023, a 22% decrease
compared to $189.9 million in the
first nine months of 2022.
- HETLIOZ® net product sales were $79.1 million in the first nine months of 2023, a
34% decrease compared to $119.6
million in the first nine 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 $68.3 million in the first nine months of 2023, a
3% decrease compared to $70.3 million
in the first nine months of 2022.
- Net income was $4.9 million in
the first nine months of 2023 compared to a net loss of
$0.6 million in the first nine months
of 2022.
- Cash, cash equivalents and marketable securities (Cash) was
$489.9 million as of September 30, 2023, representing an increase to
Cash of $35.1 million, or 8%,
compared to September 30, 2022.
Key Operational Highlights
Fanapt® (iloperidone)
- The supplemental New Drug Application (sNDA) for
Fanapt® in bipolar I disorder in adults was accepted for
filing by the U.S. Food and Drug Administration (FDA) with a
Prescription Drug User Fee Act (PDUFA) target action date of
April 2, 2024.
HETLIOZ® (tasimelteon)
- The sNDA for HETLIOZ® in insomnia was accepted for
filing by the FDA with a PDUFA target action date of March 4, 2024. Vanda is continuing to pursue FDA
approval for HETLIOZ® in jet lag disorder.
- Vanda intends to file a petition to the U.S. Supreme Court for
a writ of certiorari in its HETLIOZ® Abbreviated New
Drug Application (ANDA) litigation against Teva Pharmaceuticals
USA, Inc., Apotex Inc. and Apotex
Corp. Chief Justice Roberts extended
the time for the filing of Vanda's forthcoming petition, which
Vanda expects to file by January 12,
2024.
Tradipitant
- Vanda continues to pursue FDA approval of a New Drug
Application (NDA) for tradipitant for patients with
gastroparesis.
- Vanda initiated a second Phase III study of tradipitant in
motion sickness and the study is over 20% enrolled. Vanda
previously announced positive results in its first Phase III study
of tradipitant in motion sickness. Vanda plans to pursue FDA
approval upon completion of the clinical development program.
GAAP Financial Results
Net income was $0.1 million in the
third quarter of 2023 compared to net income of $3.3 million in the third quarter of 2022.
Diluted net income per share was $0.00 in the third quarter of 2023 compared to
diluted net income per share of $0.06
in the third quarter of 2022.
Net income was $4.9 million in the
first nine months of 2023 compared to a net loss of $0.6 million in the first nine months of 2022.
Diluted net income per share was $0.09 in the first nine months of 2023 compared
to diluted net loss per share of $0.01 in the first nine 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.
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, November 8, 2023, at 4:30 PM ET. During the call, Vanda's management
will discuss the third 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 9774278.
A replay of the call will be available on Wednesday, November 8, 2023, beginning at
8:30 PM ET and will be accessible
until Wednesday, November 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 9774278.
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, Vanda's
expectations regarding the timing of the FDA's decisions with
respect to the sNDAs for Fanapt® and
HETLIOZ®, Vanda's plans to increase and diversify its
sources of revenue, Vanda's intention to petition the U.S. Supreme
Court for a writ of certiorari in connection with its ANDA
litigation and Vanda's expectations regarding the timing thereof
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 ability
to meet the PDUFA target action dates for the sNDAs for
Fanapt® and HETLIOZ®, the FDA's assessment of
the sufficiency of the data packages included in Vanda's regulatory
submissions for Fanapt®, HETLIOZ® and
tradipitant, Vanda's ability to develop and/or acquire new products
and obtain FDA approval of new indications for its existing
products, Vanda's ability to complete the clinical program for
tradipitant in the treatment of motion sickness, Vanda's ability to
file its petition for a writ of certiorari with the U.S. Supreme
Court on or before January 12, 2024
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
|
|
Nine Months
Ended
|
|
September 30
2023
|
|
September 30
2022
|
|
September 30
2023
|
|
September 30
2022
|
Revenues:
|
|
|
|
|
|
|
|
HETLIOZ® net product sales
|
$
17,500
|
|
$
41,335
|
|
$
79,095
|
|
$
119,554
|
Fanapt® net product sales
|
21,315
|
|
23,983
|
|
68,274
|
|
70,346
|
Total
revenues
|
38,815
|
|
65,318
|
|
147,369
|
|
189,900
|
Operating
expenses:
|
|
|
|
|
|
|
|
Cost of goods sold
excluding amortization
|
3,063
|
|
6,320
|
|
11,336
|
|
18,044
|
Research and
development
|
16,600
|
|
24,857
|
|
52,484
|
|
67,316
|
Selling, general and
administrative
|
24,767
|
|
29,854
|
|
89,270
|
|
103,703
|
Intangible asset
amortization
|
380
|
|
379
|
|
1,137
|
|
1,137
|
Total operating
expenses
|
44,810
|
|
61,410
|
|
154,227
|
|
190,200
|
Income (loss) from
operations
|
(5,995)
|
|
3,908
|
|
(6,858)
|
|
(300)
|
Other
income
|
5,875
|
|
1,553
|
|
14,858
|
|
1,987
|
Income (loss) before
income taxes
|
(120)
|
|
5,461
|
|
8,000
|
|
1,687
|
Provision (benefit)
for income taxes
|
(257)
|
|
2,191
|
|
3,091
|
|
2,273
|
Net income
(loss)
|
$
137
|
|
$
3,270
|
|
$
4,909
|
|
$
(586)
|
Net income (loss) per
share, basic
|
$
0.00
|
|
$
0.06
|
|
$
0.09
|
|
$
(0.01)
|
Net income (loss) per
share, diluted
|
$
0.00
|
|
$
0.06
|
|
$
0.09
|
|
$
(0.01)
|
Weighted average shares
outstanding, basic
|
57,519,031
|
|
56,574,503
|
|
57,329,969
|
|
56,397,805
|
Weighted average shares
outstanding, diluted
|
57,595,344
|
|
56,969,033
|
|
57,512,225
|
|
56,397,805
|
VANDA PHARMACEUTICALS INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS
(in
thousands)
(unaudited)
|
|
|
September 30
2023
|
|
December 31
2022
|
ASSETS
|
|
|
|
Current
assets:
|
|
|
|
Cash and cash
equivalents
|
$
183,186
|
|
$
135,029
|
Marketable
securities
|
306,672
|
|
331,830
|
Accounts receivable,
net
|
29,272
|
|
33,512
|
Inventory
|
1,006
|
|
1,194
|
Prepaid expenses and
other current assets
|
16,436
|
|
17,727
|
Total current
assets
|
536,572
|
|
519,292
|
Property and equipment,
net
|
2,128
|
|
2,573
|
Operating lease
right-of-use assets
|
7,428
|
|
8,400
|
Intangible assets,
net
|
17,428
|
|
18,565
|
Deferred tax
assets
|
67,772
|
|
74,039
|
Non-current inventory
and other
|
10,277
|
|
11,378
|
Total
assets
|
$
641,605
|
|
$
634,247
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
Current
liabilities:
|
|
|
|
Accounts payable and
accrued liabilities
|
$
32,595
|
|
$
45,551
|
Product revenue
allowances
|
52,242
|
|
45,885
|
Total current
liabilities
|
84,837
|
|
91,436
|
Operating lease
non-current liabilities
|
7,472
|
|
8,813
|
Other non-current
liabilities
|
6,196
|
|
6,800
|
Total
liabilities
|
98,505
|
|
107,049
|
Stockholders'
equity:
|
|
|
|
Common
stock
|
58
|
|
57
|
Additional paid-in
capital
|
697,001
|
|
686,235
|
Accumulated other
comprehensive loss
|
(967)
|
|
(1,193)
|
Accumulated
deficit
|
(152,992)
|
|
(157,901)
|
Total stockholders'
equity
|
543,100
|
|
527,198
|
Total liabilities and
stockholders' equity
|
$
641,605
|
|
$
634,247
|
Corporate Contact:
Kevin Moran
Senior Vice President, Chief Financial Officer and Treasurer
Vanda Pharmaceuticals Inc.
202-734-3400
pr@vandapharma.com
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SOURCE Vanda Pharmaceuticals Inc.