- Revenues for Q2 2024 were $50.5
million, an increase of 6% compared to Q1 2024 and an
increase of 10% compared to Q2 2023
- Financial Guidance reinstated for Full Year 2024
- Fanapt® approved for the acute treatment of
bipolar I disorder; commercial launch initiated in Q3 2024
- PONVORY® commercial launch in multiple sclerosis
initiated in Q3 2024
- Tradipitant NDA review for gastroparesis ongoing; PDUFA date
of September 18, 2024
- Positive results for tradipitant second Phase III motion
sickness study results announced in May
2024; NDA expected to be submitted in Q4 2024
WASHINGTON, July 31,
2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc.
(Vanda) (Nasdaq: VNDA) today announced financial and operational
results for the second quarter ended June
30, 2024.
"2024 has been marked by the achievement of significant clinical
development milestones and the expansion of our commercial
organization to support the commercialization of Fanapt in bipolar
disorder and Ponvory in multiple sclerosis," said Mihael H. Polymeropoulos, M.D., Vanda's
President, CEO and Chairman of the Board. "The expansion of our
commercial operations positions us well for future growth as we
advance our clinical development pipeline with late-stage and
early-stage assets."
Financial Highlights
Second Quarter of 2024
- Total net product sales from Fanapt®,
HETLIOZ® and PONVORY® were $50.5 million in the second quarter of 2024, a
10% increase compared to $46.1
million in the second quarter of 2023, and a 6% increase
compared to $47.5 million in the
first quarter of 2024.
- Fanapt® net product sales were $23.2 million in the second quarter of 2024, a 4%
decrease compared to $24.1 million in
the second quarter of 2023, and a 12% increase compared to
$20.6 million in the first quarter of
2024.
- HETLIOZ® net product sales were $18.7 million in the second quarter of 2024, a
15% decrease compared to $22.0
million in the second quarter of 2023, and a 7% decrease
compared to $20.1 million in the
first quarter of 2024. The decrease relative to the second quarter
of 2023 was the result of continued generic competition in the
U.S.
- PONVORY® net product sales were $8.6 million in the second quarter of 2024, an
increase of 26% compared to $6.8
million in the first 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 $4.5 million in the
second quarter of 2024, compared to net income of $1.5 million in the second quarter of 2023, and
net loss of $4.1 million in the first
quarter of 2024.
- Cash, cash equivalents and marketable securities (Cash) was
$387.7 million as of June 30, 2024, representing a decrease to Cash of
$6.5 million compared to March 31, 2024.
First Six Months of 2024
- Total net product sales from Fanapt®,
HETLIOZ® and PONVORY® were $97.9 million in the first six months of 2024, a
10% decrease compared to $108.6
million in the first six months of 2023.
- Fanapt® net product sales were $43.7 million in the first six months of 2024, a
7% decrease compared to $47.0 million
in the first six months of 2023.
- HETLIOZ® net product sales were $38.8 million in the first six months of 2024, a
37% decrease compared to $61.6
million in the first six months of 2023. The decrease
relative to the first six months of 2023 was the result of
continued generic competition in the U.S.
- PONVORY® net product sales were $15.4 million in the first six months of 2024.
The acquisition of PONVORY® from Janssen was completed
on December 7, 2023.
- Net loss was $8.7 million in the
first six months of 2024, compared to net income of $4.8 million in the first six months of
2023.
- Cash was $387.7 million as of
June 30, 2024, representing a
decrease to Cash of $0.6 million
compared to December 31, 2023.
Key Operational Highlights
Psychiatry Portfolio
- Fanapt® (iloperidone): Vanda initiated the
commercial launch of Fanapt® for the treatment of
bipolar I disorder in adults in the third quarter of 2024,
including the expansion of its existing sales force and the
introduction of prescriber awareness and comprehensive marketing
programs.
- Milsaperidone: Vanda expects to submit a New Drug Application
(NDA) for milsaperidone (also known as VHX-896 and P-88), the
active metabolite of Fanapt®, for the treatment of
schizophrenia and acute bipolar I disorder to the U.S. Food and
Drug Administration (FDA) in early 2025.
- Iloperidone LAI: Vanda expects to initiate a Phase III program
for the long acting injectable (LAI) formulation of
Fanapt® by the end of 2024.
HETLIOZ® (tasimelteon)
- Vanda has initiated a HETLIOZ LQ® program in
pediatric insomnia. Although the prevalence of insomnia in children
is difficult to determine, it is estimated that 20-40% of children
experience significant sleep problems.1,2 There are
currently no approved treatments for pediatric insomnia.
- Vanda continues to pursue FDA approval for HETLIOZ®
for the treatment of jet lag disorder and insomnia. Vanda is
challenging the FDA's rejection of Vanda's supplemental New Drug
Application (sNDA) for the treatment of jet lag disorder in the
U.S. Court of Appeals for the D.C. Circuit. Vanda has accepted the
opportunity for a hearing with the FDA on the approvability of the
insomnia sNDA.
- Vanda's lawsuit asserting that U.S. Patent No. 11,285,129 will
be infringed by generic versions of HETLIOZ® marketed by
Teva Pharmaceuticals USA, Inc.
(Teva) and Apotex Inc. and Apotex Corp. (Apotex) is currently
pending in the U.S. District Court for the District of Delaware. Vanda announced in July 2024 that the District Court ordered that
Vanda's HETLIOZ® lawsuit may proceed.
- Vanda submitted a Marketing Authorization Application for
HETLIOZ® and a Line Extension Application for HETLIOZ
LQ® to the European Medicines Agency for the treatment
of nighttime sleep disturbances in Smith-Magenis Syndrome.
PONVORY® (ponesimod)
- Vanda announced in May 2024 that
ownership of the U.S. NDA and Investigational New Drug (IND)
applications for PONVORY® had been transferred to Vanda
from a Johnson & Johnson Company. Vanda initiated the
commercial launch of PONVORY® for the treatment of
relapsing forms of multiple sclerosis in the third quarter of 2024
including the deployment of a specialty sales force.
- Vanda expects to file IND applications with the FDA for
PONVORY® in the treatment of psoriasis and ulcerative
colitis, in 2024.
Tradipitant
- The NDA for tradipitant for the treatment of symptoms of
gastroparesis is under review by the FDA with a PDUFA target action
date of September 18, 2024. Although
the review is ongoing, the FDA provided a preliminary notice that
deficiencies preclude discussion of labeling. Gastroparesis is a
significant unmet medical need with the last treatment option
approved over 40 years ago and an estimated prevalence in the U.S.
of over 6 million individuals.3
- In May 2024, Vanda announced
positive results from the second Phase III study of tradipitant for
the treatment of motion sickness. Vanda expects to submit an NDA
for the treatment of motion sickness to the FDA in the fourth
quarter of 2024. An eventual NDA approval of tradipitant for the
treatment of motion sickness would significantly expand the
addressable patient population, with approximately 30% of the U.S.
population reported to suffer from motion sickness under ordinary
travel conditions that include travel by sea, air and
land.4
Early-Stage Programs
- VPO-227, a CFTR inhibitor for the treatment of cholera, has
received approval to proceed in a Phase I study in Bangladesh, a country where treatment of
cholera remains a significant and unmet need. Vanda plans to
initiate this study by the end of 2024.
- The Phase I clinical study for 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, expects to enroll the patient in mid-2024.
- The Phase I clinical study of VTR-297 for the treatment of
onychomycosis, a fungal infection of the nail, was initiated in
April 2024. The study is over 75%
enrolled and is expected to be completed in the third quarter of
2024.
- 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.
GAAP Financial Results
Net loss was $4.5 million in the
second quarter of 2024 compared to net income of $1.5 million in the second quarter of
2023. Diluted net loss per share was $0.08 in the second quarter of 2024 compared to
diluted net income per share of $0.03
in the second quarter of 2023.
Net loss was $8.7 million in the
first six months of 2024 compared to net income of $4.8 million in the first six months of
2023. Diluted net loss per share was $0.15 in the first six months of 2024 compared to
diluted net income per share of $0.08
in the first six months of 2023.
2024 Financial Guidance
Vanda reinstates financial guidance and expects to achieve the
following financial objectives in 2024:
|
Full Year
2024
Financial
Objectives
|
Full Year
2024
Guidance
|
|
Total
revenues
|
$180 to $210
million
|
|
Year-end 2024
Cash
|
$360 to $390
million
|
Conference Call
Vanda has scheduled a conference call for today, Wednesday, July 31, 2024, at 4:30 PM ET. During the call, Vanda's management
will discuss the second quarter 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 1278669.
A replay of the call will be available on Wednesday, July 31, 2024, beginning at
8:30 PM ET and will be accessible
until Wednesday, August 7, 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 1278669.
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
- Calhoun SL, Fernandez-Mendoza J, Vgontzas AN, Liao D, Bixler
EO. Prevalence of insomnia symptoms in a general population sample
of young children and preadolescents: gender effects. Sleep Med.
2014 Jan;15(1):91-5. doi: 10.1016/j.sleep.2013.08.787. Epub 2013
Oct 16. PMID: 24333223; PMCID: PMC3912735.
- Fricke-Oerkermann L, Plück J, Schredl M, Heinz K, Mitschke A,
Wiater A, Lehmkuhl G. Prevalence and course of sleep problems in
childhood. Sleep. 2007 Oct;30(10):1371-7. doi:
10.1093/sleep/30.10.1371. PMID:
17969471; PMCID: PMC2266270.
- Rey et al J Neurogastroenterol Motil, Jan 2012.
- Turner M, Griffin MJ. Motion sickness in public road transport:
passenger behavior and susceptibility. Ergonomics. 1999: 42:
444-461.
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 "2024 Financial Guidance"
above, and statements regarding Vanda's plans for pursuit of
FDA approval of tradipitant for the treatment of motion sickness,
milsaperidone for the treatments of schizophrenia and acute bipolar
I disorder, and HETLIOZ® for the treatments of insomnia
and jet lag disorder; Vanda's clinical development plans for the
LAI formulation of Fanapt®, PONVORY® for
the treatments of psoriasis and ulcerative colitis, VPO-227 for the
treatment of cholera, VCA-894A for the treatment of CMT2S, and
VTR-297 for the treatment of onychomycosis; the prevalence of
pediatric sleep disorders; the regulatory status of the Company's
NDA for tradipitant for the treatment of symptoms of gastroparesis;
the prevalence of gastroparesis; the commercial opportunity for
tradipitant for the treatment of motion sickness; and the impact of
generic competition on sales of HETLIOZ® in future
periods 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 to the FDA the NDAs for tradipitant for the treatment of
motion sickness and milsaperidone for the treatments of
schizophrenia and acute bipolar I disorder within the specified
timeframes; the FDA's assessment of the sufficiency of the data
packages to be included in the NDAs for tradipitant and
milsaperidone; Vanda's ability to correct the deficiencies
identified by the FDA with respect to the sNDA for
HETLIOZ® for the treatment of insomnia; the outcome in
the U.S. Court of Appeals of Vanda's challenge to the FDA's
rejection of its sNDA for HETLIOZ® for the treatment of
jet lag disorder; Vanda's ability to initiate the Phase III program
for the LAI formulation of Fanapt® by the end of 2024;
the accuracy of the estimates regarding the prevalence of pediatric
sleep disorders; Vanda's ability to file the INDs, and initiate the
Phase III studies for, PONVORY® for the treatments of
psoriasis and ulcerative colitis by the end of 2024; the outcome of
the FDA's review of Vanda's NDA for tradipitant for the treatment
of symptoms of gastroparesis; the accuracy of the estimates
regarding the prevalence of gastroparesis; Vanda's ability to
enroll patients and initiate the Phase I study for VPO-227 for the
treatment of cholera by the end of 2024; Vanda's ability to enroll
the patient for the Phase I study for VCA-894A for the treatment of
CMT2S by mid-2024; Vanda's ability to continue to enroll patients
and complete the Phase I study of VTR-297 for the treatment of
onychomycosis in the third quarter of 2024; and the ability of
generic competitors to increase their share of the market 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
2024
|
|
June 30
2023
|
|
June 30
2024
|
|
June 30
2023
|
|
Revenues:
|
|
|
|
|
|
|
|
|
Fanapt® net
product sales
|
$
23,150
|
|
$
24,077
|
|
$
43,729
|
|
$
46,959
|
|
HETLIOZ®
net product sales
|
18,708
|
|
21,979
|
|
38,761
|
|
61,595
|
|
PONVORY®
net product sales
|
8,616
|
|
—
|
|
15,446
|
|
—
|
|
Total
revenues
|
50,474
|
|
46,056
|
|
97,936
|
|
108,554
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
Cost of goods sold
excluding amortization
|
2,733
|
|
3,499
|
|
6,173
|
|
8,273
|
|
Research and
development
|
16,661
|
|
16,647
|
|
37,815
|
|
35,884
|
|
Selling, general and
administrative
|
39,474
|
|
28,399
|
|
69,559
|
|
64,503
|
|
Intangible asset
amortization
|
1,752
|
|
378
|
|
3,770
|
|
757
|
|
Total operating
expenses
|
60,620
|
|
48,923
|
|
117,317
|
|
109,417
|
|
Loss from
operations
|
(10,146)
|
|
(2,867)
|
|
(19,381)
|
|
(863)
|
|
Other
income
|
4,630
|
|
5,459
|
|
9,201
|
|
8,983
|
|
Income (loss) before
income taxes
|
(5,516)
|
|
2,592
|
|
(10,180)
|
|
8,120
|
|
Provision (benefit)
for income taxes
|
(998)
|
|
1,072
|
|
(1,516)
|
|
3,348
|
|
Net income
(loss)
|
$
(4,518)
|
|
$
1,520
|
|
$
(8,664)
|
|
$
4,772
|
|
Net income (loss) per
share, basic
|
$
(0.08)
|
|
$
0.03
|
|
$
(0.15)
|
|
$
0.08
|
|
Net income (loss) per
share, diluted
|
$
(0.08)
|
|
$
0.03
|
|
$
(0.15)
|
|
$
0.08
|
|
Weighted average shares
outstanding, basic
|
58,220,838
|
|
57,453,916
|
|
57,990,890
|
|
57,233,878
|
|
Weighted average shares
outstanding, diluted
|
58,220,838
|
|
57,535,615
|
|
57,990,890
|
|
57,469,105
|
|
VANDA
PHARMACEUTICALS INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS
(in
thousands)
(unaudited)
|
|
|
June 30
2024
|
|
December 31
2023
|
|
ASSETS
|
|
|
|
|
Current
assets:
|
|
|
|
|
Cash and cash
equivalents
|
$
102,953
|
|
$
135,821
|
|
Marketable
securities
|
284,723
|
|
252,443
|
|
Accounts receivable,
net
|
41,864
|
|
34,155
|
|
Inventory
|
1,469
|
|
1,357
|
|
Prepaid expenses and
other current assets
|
8,171
|
|
9,170
|
|
Total current
assets
|
439,180
|
|
432,946
|
|
Property and equipment,
net
|
2,303
|
|
2,037
|
|
Operating lease
right-of-use assets
|
6,375
|
|
7,103
|
|
Intangible assets,
net
|
117,599
|
|
121,369
|
|
Deferred tax
assets
|
76,559
|
|
75,000
|
|
Non-current inventory
and other
|
9,355
|
|
9,985
|
|
Total
assets
|
$
651,371
|
|
$
648,440
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
Accounts payable and
accrued liabilities
|
$
39,598
|
|
$
38,460
|
|
Product revenue
allowances
|
54,193
|
|
49,237
|
|
Total current
liabilities
|
93,791
|
|
87,697
|
|
Operating lease
non-current liabilities
|
6,005
|
|
7,006
|
|
Other non-current
liabilities
|
9,059
|
|
8,827
|
|
Total
liabilities
|
108,855
|
|
103,530
|
|
Stockholders'
equity:
|
|
|
|
|
Common
stock
|
58
|
|
58
|
|
Additional paid-in
capital
|
706,844
|
|
700,274
|
|
Accumulated other
comprehensive loss
|
(330)
|
|
(30)
|
|
Accumulated
deficit
|
(164,056)
|
|
(155,392)
|
|
Total stockholders'
equity
|
542,516
|
|
544,910
|
|
Total liabilities and
stockholders' equity
|
$
651,371
|
|
$
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
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SOURCE Vanda Pharmaceuticals Inc.