- Full year 2023 revenues were $192.6
million
- PONVORY® acquisition completed in Q4 2023 and
transition ongoing
- 3 FDA PDUFA target action dates in 2024
- Ended 2023 with approximately $388
million in cash and cash equivalents
WASHINGTON, Feb. 7, 2024
/PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA)
today announced financial and operational results for the fourth
quarter and full year ended December 31,
2023.
"Despite significant external commercial and regulatory
challenges, last year was a landmark year for Vanda, as we
supported our commercial programs and, through a transformational
deal, we added PONVORY® to our portfolio alongside
Fanapt® and HETLIOZ®," said Mihael H. Polymeropoulos, M.D., Vanda's
President, CEO and Chairman of the Board. "At the same time, we
advanced our clinical development pipeline with three NDA and sNDA
submissions for insomnia, bipolar disorder and gastroparesis.
Looking forward to this year, we are committed to advancing our
clinical development pipeline and strengthening our commercial
presence with a portfolio of innovative products serving unmet
patient needs."
Financial Highlights
Fourth Quarter of 2023
- Total net product sales from HETLIOZ®,
Fanapt® and PONVORY® were $45.3 million in the fourth quarter of 2023, a
30% decrease compared to $64.5
million in the fourth quarter of 2022, and a 17% increase
compared to $38.8 million in the
third quarter of 2023.
- HETLIOZ® net product sales were $21.1 million in the fourth quarter of 2023, a
47% decrease compared to $40.1
million in the fourth quarter of 2022, and a 20% increase
compared to $17.5 million in the
third quarter of 2023. The decrease relative to the fourth quarter
of 2022 was the result of the at-risk launch of generic versions of
HETLIOZ® in the U.S.
- Fanapt® net product sales were $22.6 million in the fourth quarter of 2023, a 7%
decrease compared to $24.4 million in
the fourth quarter of 2022, and a 6% increase compared to
$21.3 million in the third quarter of
2023.
- PONVORY® net product sales were $1.6 million in the fourth quarter of 2023. These
net product sales reflect the revenue generated during the period
between the product acquisition date of December 7, 2023 and December 31, 2023.
- Net loss was $2.4 million in the
fourth quarter of 2023 compared to net income of $6.9 million in the fourth quarter of 2022, and
net income of $0.1 million in the
third quarter of 2023.
- Cash, cash equivalents and marketable securities (Cash) was
$388.3 million as of December 31, 2023, representing a decrease to
Cash of $101.6 million compared to
September 30, 2023. During the
period, Vanda completed the acquisition of PONVORY® from
Actelion Pharmaceuticals Ltd. (Janssen), a Johnson & Johnson
Company, for $100.0 million.
Full Year 2023
- Total net product sales from HETLIOZ®,
Fanapt® and PONVORY® were $192.6 million for the full year 2023, a 24%
decrease compared to $254.4 million
for the full year 2022.
- HETLIOZ® net product sales were $100.2 million for the full year 2023, a 37%
decrease compared to $159.7 million
for the full year 2022. The decrease was the result of the at-risk
launch of generic versions of HETLIOZ® in the U.S.
- Fanapt® net product sales were $90.9 million for the full year 2023, a 4%
decrease compared to $94.7 million
for the full year 2022.
- PONVORY® net product sales were $1.6 million for the full year 2023. These net
product sales reflect the revenue generated during the period
between the product acquisition date of December 7, 2023 and December 31, 2023.
- Net income was $2.5 million for
the full year 2023 compared to net income of $6.3 million for the full year 2022.
- Cash, cash equivalents and marketable securities (Cash) was
$388.3 million as of December 31, 2023, representing a decrease to
Cash of $78.6 million, or 17%,
compared to December 31, 2022. During
the period, Vanda completed the acquisition of PONVORY®
from Janssen for $100.0 million.
Key Operational Highlights
HETLIOZ® (tasimelteon)
- The supplemental New Drug Application (sNDA) for
HETLIOZ® in the treatment of insomnia is under review by
the U.S. Food and Drug Administration (FDA) with a Prescription
Drug User Fee Act (PDUFA) target action date of March 4, 2024. Vanda announced that on
February 4, 2024, it received a
notification from the FDA stating that the FDA had identified
deficiencies that preclude discussion of labeling and postmarketing
requirements/commitments at this time. No deficiencies were
disclosed by the FDA in the notification, and the FDA stated that
the notification does not reflect a final decision on the
information under review. On February 6,
2024, Vanda filed suit in the U.S. District Court for the
District of Columbia (D.C.
District Court) challenging the FDA's conduct in reviewing the
insomnia sNDA. Vanda is asking the D.C. District Court to compel
the FDA to adhere to the legally mandated 180-day review period for
sNDAs and to declare as unlawful and void the regulations the FDA
relies upon to issue complete response letters.
- Vanda is also continuing to pursue FDA approval for
HETLIOZ® in the treatment of jet lag disorder. Vanda
announced in January 2024 that the
D.C. District Court granted Vanda's motion for summary judgment on
its claim against the FDA for unlawfully delaying a hearing on the
approvability of Vanda's sNDA for HETLIOZ® in the
treatment of jet lag disorder. The D.C. District Court ordered the
FDA to either finally resolve Vanda's jet lag sNDA or commence a
hearing on the sNDA on or before March 5,
2024.
- In January 2024, Vanda filed a
petition for a writ of certiorari with the U.S. Supreme Court to
review the decision of the U.S. Court of Appeals for the Federal
Circuit in Vanda's HETLIOZ® Abbreviated New Drug
Application (ANDA) litigation against Teva Pharmaceuticals
USA, Inc. (Teva), Apotex Inc. and
Apotex Corp. (collectively, Apotex). Teva and Apotex have waived
their opportunity to respond to Vanda's petition, which is now ripe
for decision by the U.S. Supreme Court.
Fanapt® (iloperidone)
- The article "Efficacy and Safety of Iloperidone in Bipolar
Mania: A Double-Blind, Placebo-Controlled Study" was published in
January 2024 in the Journal of
Clinical Psychiatry.1 The findings of this pivotal study
have been submitted to the FDA as part of Vanda's sNDA for
Fanapt® in the treatment of bipolar I disorder in
adults.
- The sNDA for Fanapt® in the treatment of bipolar I
disorder in adults is under review by the FDA with a PDUFA target
action date of April 2, 2024.
PONVORY® (ponesimod)
- Vanda completed the acquisition of the U.S. and Canadian rights
to PONVORY® from Janssen for $100.0 million in December
2023 and the transition is ongoing. PONVORY® is a
once-daily oral selective sphingosine-1-phosphate receptor 1
modulator, approved by the FDA and Health Canada to treat adults
with relapsing forms of multiple sclerosis, and is a potential
therapeutic candidate for the treatment of a diverse group of
inflammatory/autoimmune disorders ranging from psoriasis to
ulcerative colitis.
- Vanda announced in January 2024
that the U.S. Patent and Trademark Office (USPTO) had issued a
notice of allowance for its PONVORY® patent application,
17/962,968, covering methods for reducing clinical management
events before or during the treatment of multiple sclerosis and
methods for reinstating treatment after missed doses. When issued,
the patent is anticipated to expire on October 10, 2042. Upon issuance, Vanda intends to
list this patent in the FDA publication Approved Drug Products with
Therapeutic Equivalence Evaluations, commonly known as the Orange
Book.
Tradipitant
- The article "The Efficacy of Tradipitant in Patients with
Diabetic and Idiopathic Gastroparesis in Phase III Randomized
Placebo-Controlled Clinical Trial" was published in January 2024 in the Clinical Gastroenterology
and Hepatology Journal.2 The findings of this
pivotal study as well as a previously reported positive
placebo-controlled study in diabetic and idiopathic gastroparesis
have been submitted to the FDA as part of Vanda's New Drug
Application (NDA) for tradipitant in the treatment of symptoms of
gastroparesis in adults.3
- In December 2023, Vanda announced
that the NDA for tradipitant for the treatment of symptoms of
gastroparesis was accepted for filing and is under review by the
FDA with a PDUFA target action date of September 18, 2024.
- The second Phase III study of tradipitant in the treatment of
motion sickness is over 50% enrolled. In May
2023, Vanda previously announced positive results from its
first Phase III study of tradipitant in the treatment of motion
sickness. Vanda plans to pursue FDA approval upon completion of the
clinical development program.
Early-Stage Programs
- In January 2024, Vanda announced
that the FDA had approved the Investigational New Drug (IND)
application to evaluate VCA-894A for the treatment of a patient
with Charcot-Marie-Tooth disease, axonal, type 2S (CMT2S), an
inherited peripheral neuropathy for which there is no available
treatment.
- In January 2024, Vanda announced
that the FDA had also approved the IND to evaluate VTR-297 for the
treatment of onychomycosis, a fungal infection of the nail.
Other Legal Updates
- Vanda announced in January 2024
that the United States Court of
Federal Claims denied in part the U.S. government's motion to
dismiss Vanda's claims against the U.S. for the FDA's uncompensated
taking of Vanda's trade secrets and confidential information,
thereby allowing Vanda's lawsuit to proceed. Vanda is seeking
compensation from the U.S. for the takings it contends occurred
through the FDA's improper communication and disclosure of trade
secrets and confidential information to certain generic drug
manufacturers. Vanda now intends to engage in discovery to support
its claims.
GAAP Financial Results
Net loss was $2.4 million in the
fourth quarter of 2023 compared to net income of $6.9 million in the fourth quarter of
2022. Diluted net loss per share was $0.04 in the fourth quarter of 2023 compared to
diluted net income per share of $0.12
in the fourth quarter of 2022.
Net income was $2.5 million for
the full year 2023 compared to net income of $6.3 million for the full year 2022. Diluted net
income per share was $0.04 for the
full year 2023 compared to diluted net income per share of
$0.11 for the full year 2022.
2024 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 generic versions of HETLIOZ®, Vanda is unable
to provide 2024 financial guidance at this time.
Conference Call
Vanda has scheduled a conference call for today, Wednesday, February 7, 2024, at 4:30 PM ET. During the call, Vanda's management
will discuss the fourth quarter and full year 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 8053170. A replay of the call will be
available on Wednesday, February 7,
2024, beginning at 8:30 PM ET
and will be accessible until Wednesday,
February 14, 2024 at 11:59 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 8053170.
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.
References
- Torres R, Czeisler EL, Chadwick SR, et al. Efficacy and safety
of iloperidone in bipolar mania: a double-blind, placebo-controlled
study. J Clin Psychiatry.
https://doi.org/10.4088/JCP.23m14966
- Carlin, J. L., Polymeropoulos, C., Camilleri, M., Lembo, A.,
Fisher, M., Kupersmith, C., Madonick, D., Moszczynski, P.,
Smieszek, S., Xiao, C., Birznieks, G., & Polymeropoulos, M. H.
(2024). The efficacy of tradipitant in patients with diabetic and
idiopathic gastroparesis in phase III randomized placebo-controlled
clinical trial. Clinical Gastroenterology and Hepatology.
https://doi.org/10.1016/j.cgh.2024.01.005
- Carlin, J. L., Lieberman, V. R., Dahal, A., Keefe, M. S., Xiao,
C., Birznieks, G., Abell, T. L., Lembo, A., Parkman, H. P., &
Polymeropoulos, M. H. (2021). Efficacy and Safety of Tradipitant in
Patients with Diabetic and Idiopathic Gastroparesis in a
Randomized, Placebo-Controlled Trial. Gastroenterology, 160(1),
76–87.e4. https://doi.org/10.1053/j.gastro.2020.07.029
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 X @vandapharma.
CAUTIONARY NOTE REGARDING FORWARD LOOKING STATEMENTS
Various statements in this press release, including, but not
limited to, statements regarding the advancement of Vanda's
clinical development pipeline and strengthening of its commercial
presence, Vanda's plans for pursuit of FDA approval of
HETLIOZ® in the treatments of insomnia and jet lag
disorder, Fanapt® in the treatment of bipolar I in
adults and tradipitant in the treatment of symptoms of
gastroparesis and the treatment of motion sickness, Vanda's
expectations regarding the timing of the FDA's decisions with
respect to the sNDAs for HETLIOZ® and Fanapt®
and the NDA for tradipitant, the potential for PONVORY®
to treat a diverse group of inflammatory/autoimmune disorders, the
USPTO's plans to issue the new PONVORY® patent, the
anticipated life of the patent and Vanda's intentions to list the
patent in the Orange Book 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 the clinical development of the products in its
pipeline and obtain regulatory approval and market acceptance of
these products, Vanda's ability to obtain FDA approval of the sNDAs
for HETLIOZ® and Fanapt® and the NDA for
tradipitant, the FDA's ability to meet the PDUFA target action
dates for the sNDAs for HETLIOZ® and Fanapt®
and the NDA for tradipitant, the FDA's assessment of the
sufficiency of the data packages included in Vanda's regulatory
submissions for HETLIOZ®, Fanapt® and
tradipitant, Vanda's ability to complete the clinical program for
tradipitant in the treatment of motion sickness, the results of any
clinical trials conducted for PONVORY® in the treatment
of other inflammatory/autoimmune disorders and Vanda's ability to
obtain regulatory approval of PONVORY® for any such
additional indications, the payment by Vanda to the USPTO of all
fees required prior to the issuance of the new PONVORY®
patent, the ultimate issuance of the patent by the USPTO and
Vanda's ability to protect its intellectual property rights and
defend the new PONVORY® patent against any attempt to
invalidate it. 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
2023
|
|
December 31
2022
|
|
December 31
2023
|
|
December 31
2022
|
Revenues:
|
|
|
|
|
|
|
|
HETLIOZ® net product sales
|
$
21,072
|
|
$
40,101
|
|
$
100,167
|
|
$
159,655
|
Fanapt® net product sales
|
22,599
|
|
24,381
|
|
90,873
|
|
94,727
|
PONVORY® net product sales
|
1,600
|
|
—
|
|
1,600
|
|
—
|
Total
revenues
|
45,271
|
|
64,482
|
|
192,640
|
|
254,382
|
Operating
expenses:
|
|
|
|
|
|
|
|
Cost of goods sold
excluding amortization
|
3,460
|
|
6,238
|
|
14,796
|
|
24,282
|
Research and
development
|
24,339
|
|
18,454
|
|
76,823
|
|
85,770
|
Selling, general and
administrative
|
23,613
|
|
32,782
|
|
112,883
|
|
136,485
|
Intangible asset
amortization
|
953
|
|
379
|
|
2,090
|
|
1,516
|
Total operating
expenses
|
52,365
|
|
57,853
|
|
206,592
|
|
248,053
|
Income (loss) from
operations
|
(7,094)
|
|
6,629
|
|
(13,952)
|
|
6,329
|
Other
income
|
5,433
|
|
2,984
|
|
20,291
|
|
4,971
|
Income (loss) before
income taxes
|
(1,661)
|
|
9,613
|
|
6,339
|
|
11,300
|
Provision for income
taxes
|
739
|
|
2,752
|
|
3,830
|
|
5,025
|
Net income
(loss)
|
$
(2,400)
|
|
$
6,861
|
|
$
2,509
|
|
$
6,275
|
Net income (loss) per
share, basic
|
$
(0.04)
|
|
$
0.12
|
|
$
0.04
|
|
$
0.11
|
Net income (loss) per
share, diluted
|
$
(0.04)
|
|
$
0.12
|
|
$
0.04
|
|
$
0.11
|
Weighted average shares
outstanding, basic
|
57,532,309
|
|
56,651,984
|
|
57,380,975
|
|
56,461,877
|
Weighted average shares
outstanding, diluted
|
57,532,309
|
|
57,188,551
|
|
57,557,911
|
|
56,983,171
|
VANDA
PHARMACEUTICALS INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS
(in
thousands)
(unaudited)
|
|
|
December 31
2023
|
|
December 31
2022
|
ASSETS
|
|
|
|
Current
assets:
|
|
|
|
Cash and cash
equivalents
|
$
135,821
|
|
$
135,029
|
Marketable
securities
|
252,443
|
|
331,830
|
Accounts receivable,
net
|
34,155
|
|
33,512
|
Inventory
|
1,357
|
|
1,194
|
Prepaid expenses and
other current assets
|
9,170
|
|
17,727
|
Total current
assets
|
432,946
|
|
519,292
|
Property and equipment,
net
|
2,037
|
|
2,573
|
Operating lease
right-of-use assets
|
7,103
|
|
8,400
|
Intangible assets,
net
|
121,369
|
|
18,565
|
Deferred tax
assets
|
75,000
|
|
74,039
|
Non-current inventory
and other
|
9,985
|
|
11,378
|
Total
assets
|
$
648,440
|
|
$
634,247
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
Current
liabilities:
|
|
|
|
Accounts payable and
accrued liabilities
|
$
38,460
|
|
$
45,551
|
Product revenue
allowances
|
49,237
|
|
45,885
|
Total current
liabilities
|
87,697
|
|
91,436
|
Operating lease
non-current liabilities
|
7,006
|
|
8,813
|
Other non-current
liabilities
|
8,827
|
|
6,800
|
Total
liabilities
|
103,530
|
|
107,049
|
Stockholders'
equity:
|
|
|
|
Common
stock
|
58
|
|
57
|
Additional paid-in
capital
|
700,274
|
|
686,235
|
Accumulated other
comprehensive loss
|
(30)
|
|
(1,193)
|
Accumulated
deficit
|
(155,392)
|
|
(157,901)
|
Total stockholders'
equity
|
544,910
|
|
527,198
|
Total liabilities and
stockholders' equity
|
$
648,440
|
|
$
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.