- Q4 2024 total revenues of $53.2
million, +17% compared to Q4 2023
- Q4 2024 Fanapt® net product sales of $26.6 million, +18% compared to Q4 2023
- Full year 2024 total revenues of $198.8 million, +3% compared to full year
2023
- Full year 2025 revenue expected to grow to $210 to $250
million
- Psychiatry portfolio revenue expected to grow to greater
than $750 million in 2030
- Fanapt® MAA for bipolar I disorder and
schizophrenia submitted in Q4 2024
- BysantiTM (milsaperidone) NDA for bipolar I
disorder and schizophrenia expected to be submitted in Q1
2025
- HETLIOZ® MAA for Smith-Magenis syndrome submitted
in Q4 2024
- Tradipitant NDA for motion sickness submitted in Q4
2024
- Imsidolimab BLA in generalized pustular psoriasis expected
to be submitted in 2025
WASHINGTON, Feb. 13, 2025 /PRNewswire/ -- Vanda
Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced
financial and operational results for the fourth quarter and full
year ended December 31, 2024.
"Strong revenue growth for Fanapt is putting us on a significant
growth trajectory for 2025 and beyond, supported also by the
commercial performance of Hetlioz and Ponvory. The Fanapt long
acting injectable program, the NDA for Bysanti for bipolar disorder
and schizophrenia along with its development for major depressive
disorder have the potential to drive future growth in our
psychiatry portfolio for many years to come," said Mihael H. Polymeropoulos, M.D., Vanda's
President, CEO and Chairman of the Board. "Tradipitant's NDA for
motion sickness was filed with a potential approval this year,
while we are pursuing approval in gastroparesis and the development
of tradipitant to improve tolerability of GLP-1 analog Wegovy.
Our anti-inflammatory portfolio, anchored by Ponvory, was
strengthened with the addition of imsidolimab from Anaptys, an
IL-36 receptor inhibitor for the treatment of generalized pustular
psoriasis. We plan to file a BLA later this year while we are
exploring registration in Europe
and Japan as well as the
development of this novel drug for other inflammatory disorders
with an unopposed action of the IL-36 system. In 2024 we returned
to revenue growth driven by the commercial launches in bipolar
disorder and multiple sclerosis and advanced our development
pipeline with a number of products at or near marketing
applications. All this was achieved by the hard work, ingenuity and
efficiency of our organization and its wonderful people."
Financial Highlights
Fourth Quarter of 2024
- Total net product sales from Fanapt®,
HETLIOZ® and PONVORY® were $53.2 million in the fourth quarter of 2024, a
17% increase compared to $45.3
million in the fourth quarter of 2023 and a 12% increase
compared to $47.7 million in the
third quarter of 2024.
- Fanapt® net product sales were $26.6 million in the fourth quarter of 2024, an
18% increase compared to $22.6
million in the fourth quarter of 2023 and an 11% increase
compared to $23.9 million in the
third quarter of 2024.
- HETLIOZ® net product sales were $20.0 million in the fourth quarter of 2024, a 5%
decrease compared to $21.1 million in
the fourth quarter of 2023 and a 12% increase compared to
$17.9 million in the third quarter of
2024.
- PONVORY® net product sales were $6.5 million in the fourth quarter of 2024, an
increase of 11% compared to $5.9
million in the third quarter of 2024. The acquisition of
PONVORY® from Actelion Pharmaceuticals Ltd. (Janssen), a
Johnson & Johnson Company, was completed on December 7, 2023.
- Net loss was $4.9 million in the
fourth quarter of 2024 compared to net loss of $2.4 million in the fourth quarter of 2023 and
net loss of $5.3 million in the third
quarter of 2024.
- Cash, cash equivalents and marketable securities (Cash) was
$374.6 million as of December 31, 2024, representing a decrease to
Cash of $1.6 million compared to
September 30, 2024.
Full Year 2024
- Total net product sales from Fanapt®,
HETLIOZ® and PONVORY® were $198.8 million for the full year 2024, a 3%
increase compared to $192.6 million
for the full year 2023.
- Fanapt® net product sales were $94.3 million for the full year 2024, a 4%
increase compared to $90.9 million
for the full year 2023.
- HETLIOZ® net product sales were $76.7 million for the full year 2024, a 23%
decrease compared to $100.2 million
for the full year 2023. The decrease relative to the full year 2023
was the result of continued generic competition in the U.S.
- PONVORY® net product sales were $27.8 million for the full year 2024. The
acquisition of PONVORY® from Janssen was completed on
December 7, 2023.
- Net loss was $18.9 million for
the full year 2024, compared to net income of $2.5 million for the full year 2023.
- Cash was $374.6 million as of
December 31, 2024, representing a
decrease to Cash of $13.6 million
compared to December 31, 2023.
Key Operational Highlights
Fanapt® (iloperidone)
- Fanapt® was approved in the second quarter of 2024
for the acute treatment of bipolar I disorder. Vanda initiated the
commercial launch of Fanapt® in this indication in the
third quarter of 2024. In the fourth quarter of 2024, as compared
to the fourth quarter of 2023, new patient starts, as reflected by
new to brand prescriptions (NBRx),1 increased by over
160% and Fanapt® net product sales increased by
18%.
- Vanda initiated a Phase III program for the long acting
injectable (LAI) formulation of Fanapt® in the fourth
quarter of 2024.
- Vanda plans to initiate a study of the Fanapt®
LAI as a once-a-month injectable for the treatment of
hypertension to address both treatment resistance and treatment
compliance.
- Vanda submitted a Marketing Authorization Application (MAA) to
the European Medicines Agency (EMA) in the fourth quarter of 2024
for Fanapt® for bipolar I disorder and
schizophrenia.
Bysanti™ (milsaperidone)
- Vanda expects to submit a New Drug Application (NDA) for
Bysanti™ to the U.S. Food and Drug Administration (FDA) for the
treatments of acute bipolar I disorder and schizophrenia in the
first quarter of 2025. Exclusivity, including pending patent
applications, could extend into the 2040s.
- Vanda initiated a Phase III clinical study for Bysanti™ as a
once-daily adjunctive treatment for major depressive disorder (MDD)
in the fourth quarter of 2024. Results are expected in 2026.
HETLIOZ® (tasimelteon)
- Vanda has initiated clinical programs for HETLIOZ®
in pediatric insomnia and delayed sleep phase disorder (DSPD) and
these programs are ongoing.
- Vanda's MAA for HETLIOZ® and HETLIOZ LQ®
for Smith-Magenis Syndrome (SMS) is pending with the EMA.
PONVORY® (ponesimod)
- Vanda initiated the commercial launch of PONVORY®
for the treatment of relapsing forms of multiple sclerosis in the
third quarter of 2024.
- Investigational New Drug (IND) applications for
PONVORY® in the treatments of psoriasis and ulcerative
colitis were accepted by the FDA in the fourth quarter of
2024.
Tradipitant
- The NDA for tradipitant for the treatment of motion sickness
was submitted to the FDA in the fourth quarter of 2024.
- Vanda initiated a clinical trial to study tradipitant in the
prevention of vomiting induced by a GLP-1 analog, Wegovy
(semaglutide), in the fourth quarter of 2024.
- Vanda has accepted the opportunity for a hearing with the FDA
on the approvability of the NDA for tradipitant for the treatment
of symptoms of gastroparesis.
Imsidolimab
- In February 2025, Vanda announced
it entered into an exclusive, global license agreement with
AnaptysBio, Inc. (Anaptys) for the development and
commercialization of imsidolimab (IL-36R antagonist mAb). Vanda
expects to initiate and complete the technology transfer activities
in 2025 and immediately begin preparing the Biologics License
Application (BLA) and MAA for generalized pustular psoriasis (GPP)
for the US and EU. The imsidolimab BLA for GPP is expected to be
submitted to the FDA in 2025.
Early-Stage Program Highlights
- VQW-765, an alpha-7 nicotinic acetylcholine receptor partial
agonist, is currently in clinical development for the treatment of
acute performance anxiety in social situations. Vanda expects to
initiate a Phase III program in 2025.
- The IND application for VCA-894A in the treatment of
Charcot-Marie-Tooth disease, axonal, type 2S (CMT2S), an inherited
peripheral neuropathy for which there is no available treatment,
was accepted by the FDA in 2024. Previously in 2023, VCA-894A was
granted Orphan Drug Designation for the same indication. The Phase
I clinical study for VCA-894A expects to enroll the patient by
mid-2025.
- In December 2024, Vanda announced
that the FDA has granted Orphan Drug Designation for VGT-1849A, a
selective antisense oligonucleotide (ASO)-based JAK2 inhibitor for
the treatment of polycythemia vera (PV), a form of a rare
hematologic malignancy that is estimated to affect 1 in 2,000
Americans.
Key Regulatory Milestones
- Tradipitant NDA for motion sickness submitted in Q4 2024.
- Fanapt® MAA for bipolar I disorder and schizophrenia
submitted in Q4 2024.
- HETLIOZ® MAA in Smith-Magenis syndrome (SMS)
submitted in Q4 2024.
- Bysanti™ NDA for bipolar I disorder and schizophrenia expected
to be submitted in Q1 2025.
- Imsidolimab BLA in generalized pustular psoriasis expected to
be submitted in 2025.
GAAP Financial Results
Net loss was $4.9 million in the
fourth quarter of 2024 compared to net loss of $2.4 million in the fourth quarter of 2023.
Diluted net loss per share was $0.08
in the fourth quarter of 2024 compared to diluted net loss per
share of $0.04 in the fourth quarter
of 2023.
Net loss was $18.9 million for the
full year 2024 compared to net income of $2.5 million for the full year 2023. Diluted net
loss per share was $0.33 for the full
year 2024 compared to diluted net income per share of $0.04 for the full year 2023.
2025 Financial Guidance and 2030 Revenue Targets
Vanda expects to achieve the following financial objectives in
2025:
|
Full Year
2025
Financial
Objectives
|
Full Year
2025
Guidance
|
|
Total
revenues
|
$210 to $250
million
|
Vanda is providing 2030 revenue targets. For the psychiatry
portfolio alone, Vanda is targeting annual revenue in excess of
$750 million in 2030, assuming the
potential approval of Bysanti™ for the treatments of acute bipolar
I disorder and schizophrenia in early 2026, the potential approval
of Bysanti™ for the treatment of MDD, and the potential approval of
Fanapt® LAI. Vanda is also targeting total annual
revenue in excess of $1 billion in
2030.
Conference Call
Vanda has scheduled a conference call for today, Thursday, February 13, 2025, at 4:30 PM ET. During the call, Vanda's management
will discuss the fourth quarter and full year 2024 financial
results and other corporate activities. Investors can call
1-800-715-9871 (domestic) or 1-646-307-1963 (international) and use
passcode number 2881765. A replay of the call will be available on
Thursday, February 13, 2025,
beginning at 8:30 PM ET and will be
accessible until Thursday, February 20,
2025 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
2881765.
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
- IQVIA Prescription Data
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, the guidance provided under "2025 Financial Guidance
and 2030 Revenue Targets" above and the related implied growth of
Vanda's business, and statements regarding Vanda's plans for
pursuit of FDA approval of BysantiTM for the treatments
of acute bipolar I disorder and schizophrenia and imsidolimab for
the treatment of GPP, and the related timelines; Vanda's
expectations with respect to the growth opportunities for its
psychiatry frachise; Vanda's consideration of foreign regulatory
approval for imsidolimab and its potential development for other
inflammatory disorders; Vanda's clinical development plans and
expected timelines for Fanapt® LAI, BysantiTM
for the treatment of MDD, VQW-765 for the treatment of acute
performance anxiety in social situations, and VCA-894A for the
treatment of CMT2S; the commercial and therapeutic potential for
BysantiTM; the potential to extend patent exclusivity
for BysantiTM into the 2040s; the anticipated timing of
the initiation and completion of technology transfer activities and
the preparation of regulatory filings in the US and EU for
imsidolimab; and the prevalence of PV 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 continue to grow its psychiatry
portfolio and overall business; the results of Vanda's review
of foreign regulatory opportunities for imsidolmab; Vanda's ability
to identify additional indications for imsidolimab; Vanda's ability
to complete and submit to the FDA the NDA for BysantiTM
for the treatments of acute bipolar I disorder and schizophrenia in
the first quarter of 2025; Vanda's ability to complete and
submit the BLA for imsidolimab for the treatment of GPP in
2025; Vanda's ability to complete the Phase III clinical study for
BysantiTM for MDD and receive results in 2026; Vanda's
ability to initiate the Phase III program for VQW-765 in 2025;
Vanda's ability to enroll the CMT2S patient in the Phase I clinical
study for VCA-894A by mid-2025; Vanda's ability to complete the
clinical development of, obtain regulatory approval for, and
successfully commercialize, BysantiTM for the treatments
of acute bipolar I disorder, schizophrenia and MDD; Vanda's ability
to satisfy the conditions necessary to extend
BysantiTM's patent exclusivity into the 2040s; Vanda's
ability to initiate and complete the technology transfer activities
and prepare the BLA and MAA for imsidolimab in the specified
timeframes; and the accuracy of the estimate regarding the
prevalence of PV. 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
2024
|
|
December 31
2023
|
|
December 31
2024
|
|
December 31
2023
|
|
Revenues:
|
|
|
|
|
|
|
|
|
Fanapt® net
product sales
|
$
26,649
|
|
$
22,599
|
|
$
94,297
|
|
$
90,873
|
|
HETLIOZ®
net product sales
|
20,044
|
|
21,072
|
|
76,675
|
|
100,167
|
|
PONVORY®
net product sales
|
6,492
|
|
1,600
|
|
27,800
|
|
1,600
|
|
Total
revenues
|
53,185
|
|
45,271
|
|
198,772
|
|
192,640
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
Cost of goods sold
excluding amortization
|
2,590
|
|
3,460
|
|
11,314
|
|
14,796
|
|
Research and
development
|
19,840
|
|
24,339
|
|
74,431
|
|
76,823
|
|
Selling, general and
administrative
|
39,282
|
|
23,613
|
|
146,414
|
|
112,883
|
|
Intangible asset
amortization
|
1,752
|
|
953
|
|
7,273
|
|
2,090
|
|
Total operating
expenses
|
63,464
|
|
52,365
|
|
239,432
|
|
206,592
|
|
Loss from
operations
|
(10,279)
|
|
(7,094)
|
|
(40,660)
|
|
(13,952)
|
|
Other income,
net
|
3,782
|
|
5,433
|
|
17,739
|
|
20,291
|
|
Income (loss) before
income taxes
|
(6,497)
|
|
(1,661)
|
|
(22,921)
|
|
6,339
|
|
Provision (benefit)
for income taxes
|
(1,585)
|
|
739
|
|
(4,021)
|
|
3,830
|
|
Net income
(loss)
|
$
(4,912)
|
|
$
(2,400)
|
|
$
(18,900)
|
|
$
2,509
|
|
Net income (loss) per
share, basic
|
$
(0.08)
|
|
$
(0.04)
|
|
$
(0.33)
|
|
$
0.04
|
|
Net income (loss) per
share, diluted
|
$
(0.08)
|
|
$
(0.04)
|
|
$
(0.33)
|
|
$
0.04
|
|
Weighted average shares
outstanding, basic
|
58,308,487
|
|
57,532,309
|
|
58,149,087
|
|
57,380,975
|
|
Weighted average shares
outstanding, diluted
|
58,308,487
|
|
57,532,309
|
|
58,149,087
|
|
57,557,911
|
|
VANDA
PHARMACEUTICALS INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS
(in
thousands)
(unaudited)
|
|
|
December 31
2024
|
|
December 31
2023
|
|
ASSETS
|
|
|
|
|
Current
assets:
|
|
|
|
|
Cash and cash
equivalents
|
$
102,316
|
|
$
135,821
|
|
Marketable
securities
|
272,327
|
|
252,443
|
|
Accounts receivable,
net
|
47,101
|
|
34,155
|
|
Inventory
|
1,726
|
|
1,357
|
|
Prepaid expenses and
other current assets
|
15,420
|
|
9,170
|
|
Total current
assets
|
438,890
|
|
432,946
|
|
Property and equipment,
net
|
2,132
|
|
2,037
|
|
Operating lease
right-of-use assets
|
5,602
|
|
7,103
|
|
Finance lease
right-of-use assets
|
4,943
|
|
—
|
|
Intangible assets,
net
|
114,096
|
|
121,369
|
|
Deferred tax
assets
|
81,440
|
|
75,000
|
|
Non-current inventory
and other
|
9,101
|
|
9,985
|
|
Total
assets
|
$
656,204
|
|
$
648,440
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
Accounts payable and
accrued liabilities
|
$
39,086
|
|
$
38,460
|
|
Product revenue
allowances
|
60,895
|
|
49,237
|
|
Total current
liabilities
|
99,981
|
|
87,697
|
|
Operating lease
non-current liabilities
|
4,944
|
|
7,006
|
|
Finance lease
non-current liabilities
|
3,146
|
|
—
|
|
Other non-current
liabilities
|
9,587
|
|
8,827
|
|
Total
liabilities
|
117,658
|
|
103,530
|
|
Stockholders'
equity:
|
|
|
|
|
Common
stock
|
58
|
|
58
|
|
Additional paid-in
capital
|
712,706
|
|
700,274
|
|
Accumulated other
comprehensive income (loss)
|
74
|
|
(30)
|
|
Accumulated
deficit
|
(174,292)
|
|
(155,392)
|
|
Total stockholders'
equity
|
538,546
|
|
544,910
|
|
Total liabilities and
stockholders' equity
|
$
656,204
|
|
$
648,440
|
Corporate Contact:
Kevin Moran
Senior Vice President, Chief Financial Officer and Treasurer
Vanda Pharmaceuticals Inc.
202-734-3400
pr@vandapharma.com
Jim Golden / Jack Kelleher / Dan
Moore
Collected Strategies
VANDA-CS@collectedstrategies.com
Follow us on X @vandapharma
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SOURCE Vanda Pharmaceuticals Inc.
