WASHINGTON ,
May 5,
2022 /PRNewswire/ -- Vanda Pharmaceuticals Inc.
(Vanda) (Nasdaq: VNDA) today announced financial and operational
results for the first quarter ended March
31, 2022.
"We are excited with our progress in improving patient access
for HETLIOZ®, especially for Medicaid beneficiaries with
Non-24 and SMS diagnoses," said Mihael H.
Polymeropoulos, M.D., Vanda's President, CEO and Chairman of
the Board. "Further, we now anticipate completing enrollment of the
Fanapt® bipolar disorder study by the end of this year
and look forward to expanding our psychiatry franchise. Today we
are sharing details of our advanced analysis of data from the
tradipitant clinical program in gastroparesis, which support the
efficacy of tradipitant, and we look forward to discussing our
planned New Drug Application with the FDA."
Financial Highlights
- Total net product sales from HETLIOZ® and
Fanapt® were $60.2 million
in the first quarter of 2022, a 4% decrease compared to
$62.7 million in the first quarter of
2021.
- HETLIOZ® net product sales were $37.0 million in the first quarter of 2022, a 6%
decrease compared to $39.3 million in
the first quarter of 2021, due in part to the continued
reimbursement challenges for prescriptions for patients with
Non-24.
- Fanapt® net product sales were $23.2 million in the first quarter of 2022, a 1%
decrease compared to $23.3 million in
the first quarter of 2021.
- Net loss was $6.4 million in the
first quarter of 2022 compared to net income of $8.7 million in the first quarter of 2021.
- Cash, cash equivalents and marketable securities (Cash) was
$435.2 million as of March 31, 2022, representing an increase to Cash
of $57.0 million compared to
March 31, 2021 and an increase to
Cash of $2.4 million compared to
December 31, 2021.
Key Operational Highlights
HETLIOZ® (tasimelteon)
- Clinical trials for HETLIOZ® in delayed sleep phase
disorder (DSPD) and symptoms of autism spectrum disorder (ASD) are
currently enrolling patients.
- Since November 2021, more than 15
states have revised or agreed to revise their Medicaid prior
authorization criteria to broaden access to HETLIOZ® for
patients with Non-24 and nighttime sleep disturbances in
Smith-Magenis Syndrome (SMS).
- In January 2022, Vanda settled
its HETLIOZ® patent litigation against one of the
defendants. The trial for the consolidated lawsuit against the
remaining defendants was held in March
2022. A decision is expected from the court in the second
half of 2022.
Tradipitant
Tradipitant is a neurokinin-1 (NK-1) receptor antagonist in
development for the treatment of idiopathic and diabetic
gastroparesis. Earlier in the year, Vanda reported results of a
clinical study and initial exploratory analysis. Vanda has now
completed a pooled analysis of two clinical studies of tradipitant
in gastroparesis consisting of 342 patients with relevant clinical
endpoints. We believe these studies are adequate and well
controlled and support substantial evidence of efficacy of
tradipitant. Figure 1 and Table 1 show the results of such pooled
analysis of all patients randomized in the two studies (intent to
treat population, ITT) and Figure 2 and Table 2 show the results
for the same parameters in the population of patients who were
judged as compliant to treatment based on analysis of drug exposure
(treatment compliant population).
Table 1: Week 4 Pooled Analysis: ITT Population for
Study 1 and Study 2
|
Tradipitant
n=175
|
Placebo
n=167
|
P-value
|
DD-Nausea
|
-1.15
|
-0.85
|
0.0138
|
% Nausea Free
Days
|
20.96
|
12.52
|
0.0085
|
PGI-C
|
2.72
|
3.00
|
0.0237
|
Overall Benefit
Score
|
1.13
|
0.88
|
0.0115
|
GCSI
|
-0.99
|
-0.76
|
0.0265
|
Table 2: Week 4 Pooled Analysis: Treatment Compliant
Population for Study 1 and Study 2
|
Tradipitant
n=117
|
Placebo
n=167
|
P-value
|
DD-Nausea
|
-1.37
|
-0.85
|
0.0002
|
% Nausea Free
Days
|
27.44
|
12.58
|
0.0001
|
PGI-C
|
2.53
|
2.99
|
0.0009
|
Overall Benefit
Score
|
1.27
|
0.88
|
0.0005
|
GCSI
|
-1.15
|
-0.75
|
0.0007
|
Consistently, both pooled analyses show tradipitant to be
superior to placebo in key clinical parameters including
improvement in DD-Nausea (primary endpoint parameter), percent
Nausea Free Days, Patient Global Impression scale change (PGI-C),
Overall Benefit Score and Gastroparesis Cardinal Symptom Index
(GCSI) score.
- Vanda is continuing to conduct an open-label study of safety
for tradipitant in gastroparesis and continues to receive requests
from patients reaching out to gain access to tradipitant through
the Expanded Access program which has multiple patients continuing
to take tradipitant for more than a year.
- Vanda has scheduled a pre-NDA meeting with the U.S. Food and
Drug Administration (FDA) to discuss the planned New Drug
Application submission for tradipitant in the short-term treatment
of nausea in gastroparesis.
- The Phase III study of tradipitant in the treatment of motion
sickness has restarted enrollment and is already over 15% enrolled.
A prior Phase II study of tradipitant in the treatment of motion
sickness observed a significantly lower incidence of vomiting in
tradipitant-treated patients as compared to placebo-treated
patients.
Fanapt® (iloperidone)
- A Phase III study of Fanapt® in acute manic episodes
in patients with bipolar disorder is over 75% enrolled and expected
to complete enrollment by the end of 2022.
GAAP Financial Results
Net loss was $6.4 million in the
first quarter of 2022 compared to net income of $8.7 million in the first quarter of
2021. Diluted net loss per share was $0.11 in the first quarter of 2022 compared to
diluted net income per share of $0.15
in the first quarter of 2021.
2022 Financial Guidance
Vanda expects to achieve the following financial objectives in
2022:
Full Year
2022
Financial
Objectives
|
Full Year
2022
Guidance
|
Total
revenues
|
$240 to $280
million
|
HETLIOZ® net
product sales
|
$150 to $180
million
|
Fanapt® net
product sales
|
$90 to $100
million
|
Year-end 2022
Cash
|
Greater than $440
million
|
Conference Call
Vanda has scheduled a conference call for today, Thursday, May 5, 2022, at 4:30 PM ET. During the call, Vanda's management
will discuss the first quarter 2022 financial results and other
corporate activities. Investors can call 1-866-688-9426 (domestic)
or 1-409-216-0816 (international) and use passcode number 1355275.
A replay of the call will be available on Thursday, May 5, 2022, beginning at 7:30 PM ET and will be accessible until
Thursday, May 12, 2022 at
7:30 PM ET. The replay call-in number
is 1-855-859-2056 for domestic callers and 1-404-537-3406 for
international callers. The passcode number is 1355275.
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, the guidance provided under "2022 Financial Guidance"
above and statements regarding Vanda's plans for continued pursuit
of regulatory approval of tradipitant for the treatment of
gastroparesis, the timing of the court's decision with respect to
the Company's HETLIOZ® patent litigation and the
clinical development timelines for Fanapt® 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 assumptions regarding the
strength of its business in the U.S., the FDA's willingness to meet
with Vanda to discuss the planned NDA submission for tradipitant
and Vanda's ability to complete enrollment of the Phase III
clinical study of Fanapt® in bipolar disorder.
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 Annual Report on Form 10-K for the
fiscal year ended December 31, 2021,
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
|
|
March 31
2022
|
|
March 31
2021
|
Revenues:
|
|
|
|
HETLIOZ® net
product sales
|
$
37,031
|
|
$
39,343
|
Fanapt® net
product sales
|
23,161
|
|
23,326
|
Total revenues
|
60,192
|
|
62,669
|
Operating
expenses:
|
|
|
|
Cost of goods sold excluding amortization
|
5,665
|
|
6,030
|
Research and development
|
20,969
|
|
16,131
|
Selling, general and administrative
|
40,848
|
|
29,797
|
Intangible asset amortization
|
379
|
|
370
|
Total operating
expenses
|
67,861
|
|
52,328
|
Income (loss) from
operations
|
(7,669)
|
|
10,341
|
Other income
|
105
|
|
87
|
Income (loss) before
income taxes
|
(7,564)
|
|
10,428
|
Provision (benefit) for income taxes
|
(1,134)
|
|
1,778
|
Net income
(loss)
|
$
(6,430)
|
|
$
8,650
|
Net income (loss) per
share, basic
|
$
(0.11)
|
|
$
0.16
|
Net income (loss) per
share, diluted
|
$
(0.11)
|
|
$
0.15
|
Weighted average shares
outstanding, basic
|
56,105,239
|
|
55,145,789
|
Weighted average shares
outstanding, diluted
|
56,105,239
|
|
56,505,087
|
VANDA PHARMACEUTICALS INC.
|
CONDENSED
CONSOLIDATED BALANCE SHEETS
|
(in
thousands)
|
(unaudited)
|
|
|
March 31
2022
|
|
December 31
2021
|
ASSETS
|
|
|
|
Current
assets:
|
|
|
|
Cash and cash equivalents
|
$
66,927
|
|
$
52,071
|
Marketable securities
|
368,249
|
|
380,742
|
Accounts receivable, net
|
30,497
|
|
32,467
|
Inventory
|
1,290
|
|
1,025
|
Prepaid expenses and other current assets
|
25,305
|
|
11,996
|
Total current assets
|
492,268
|
|
478,301
|
Property and equipment,
net
|
2,917
|
|
3,113
|
Operating lease
right-of-use assets
|
8,945
|
|
9,272
|
Intangible assets,
net
|
19,702
|
|
20,081
|
Deferred tax
assets
|
70,798
|
|
74,878
|
Non-current inventory
and other
|
8,928
|
|
8,147
|
Total assets
|
$
603,558
|
|
$
593,792
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
Current
liabilities:
|
|
|
|
Accounts payable and accrued liabilities
|
$
51,394
|
|
$
34,438
|
Product revenue allowances
|
39,348
|
|
39,981
|
Total current
liabilities
|
90,742
|
|
74,419
|
Operating lease non-current liabilities
|
9,660
|
|
10,055
|
Other non-current liabilities
|
1,033
|
|
4,390
|
Total liabilities
|
101,435
|
|
88,864
|
Stockholders'
equity:
|
|
|
|
Common stock
|
56
|
|
56
|
Additional paid-in capital
|
674,001
|
|
669,223
|
Accumulated other comprehensive loss
|
(1,328)
|
|
(175)
|
Accumulated deficit
|
(170,606)
|
|
(164,176)
|
Total stockholders'
equity
|
502,123
|
|
504,928
|
Total liabilities and
stockholders' equity
|
$
603,558
|
|
$
593,792
|
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.