WASHINGTON, May 5, 2021 /PRNewswire/ -- Vanda
Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced
financial and operational results for the first quarter ended
March 31, 2021.
"Despite seasonal and global challenges, we recorded another
quarter of strong revenue across our commercial portfolio coupled
with the launch of HETLIOZ® in the new indication of
nighttime sleep disturbances in patients with Smith-Magenis
Syndrome," said Mihael H.
Polymeropoulos, M.D., President and CEO of Vanda. "In our
clinical programs, we have made significant progress, reaching 85%
randomization in our Phase III tradipitant study in gastroparesis
and initiating a new clinical program for HETLIOZ® in
delayed sleep phase disorder."
Financial Highlights
- Total net product sales from HETLIOZ® and
Fanapt® were $62.7 million
in the first quarter of 2021, an 8% increase compared to
$58.0 million in the first quarter of
2020.
- HETLIOZ® net product sales were $39.3 million in the first quarter of 2021, an
11% increase compared to $35.3
million in the first quarter of 2020.
- Fanapt® net product sales were $23.3 million in the first quarter of 2021, a 3%
increase compared to $22.7 million in
the first quarter of 2020.
- Income before taxes was $10.4
million in the first quarter of 2021 compared to
$1.2 million in the first quarter of
2020.
- Cash, cash equivalents and marketable securities (Cash) was
$378.2 million as of March 31, 2021, representing an increase to Cash
of $65.8 million compared to
March 31, 2020.
Key Operational Highlights
Tradipitant
- The gastroparesis Phase III clinical study (VP-VLY-686-3301) is
ongoing. The study has a target enrollment of 200 randomized
patients and is expected to complete enrollment in the second
quarter of 2021, with a New Drug Application (NDA) filing expected
in late 2021 or early 2022.
HETLIOZ® (tasimelteon)
- In December 2020, the U.S. Food
and Drug Administration (FDA) approved HETLIOZ® capsule
and liquid formulations for the treatment of adults and children,
respectively, with nighttime sleep disturbances in Smith-Magenis
Syndrome (SMS).1 HETLIOZ® capsules, for
adults with SMS, were immediately available after approval and the
HETLIOZ LQ™ liquid formulation, for children with SMS,
became available in the first quarter of 2021.
- A Phase III clinical study of HETLIOZ® in delayed
sleep phase disorder (DSPD) was initiated in the first quarter of
2021.
Fanapt® (iloperidone)
- A Phase III clinical study of Fanapt® in bipolar
disorder resumed during the first quarter of 2021 after pausing in
2020 due to the COVID-19 pandemic.
- Development of the long acting injectable (LAI) formulation of
Fanapt® is ongoing.
- A clinical development program of Fanapt® in
Parkinson's disease psychosis (PDP) was initiated in the first
quarter of 2021.
GAAP Financial Results
Income before taxes was $10.4
million in the first quarter of 2021 compared to
$1.2 million in the first quarter of
2020. Net income was $8.7 million in
the first quarter of 2021 compared to net income of $0.5 million in the first quarter of
2020. Diluted net income per share was $0.15 in the first quarter of 2021 compared to
diluted net income per share of $0.01
in the first quarter of 2020.
2021 Financial Guidance
Vanda expects to achieve the following financial objectives in
2021:
Full Year
2021
Financial
Objectives
|
Full Year
2021
Guidance
|
Total
revenues
|
$270 to $300
million
|
HETLIOZ®
net product sales
|
$180 to $200
million
|
Fanapt®
net product sales
|
$90 to $100
million
|
Year-end 2021
Cash
|
Greater than $400
million
|
Conference Call
Vanda has scheduled a conference call for today, Wednesday, May 5, 2021, at 4:30 PM ET. During the call, Vanda's management
will discuss the first quarter 2021 financial results and other
corporate activities. Investors can call 1-866-688-9426 (domestic)
or 1-409-216-0816 (international) and use passcode 5709209. A
replay of the call will be available on Wednesday, May 5, 2021, beginning at 7:30 PM ET and will be accessible until
Wednesday, May 12, 2021 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 5709209.
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
- Refer to Company press release titled "FDA Approves
HETLIOZ® (tasimelteon) for the Treatment of Nighttime
Sleep Disturbances in Smith-Magenis Syndrome" issued on
December 1, 2020.
https://vandapharmaceuticalsinc.gcs-web.com/node/14306/pdf
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 "2021
Financial Guidance" above and statements regarding the clinical
development and regulatory timelines for tradipitant 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 its
ability to continue to grow its business in the U.S. and Vanda's
ability to complete the clinical development and obtain regulatory
approval for tradipitant in the treatment of gastroparesis.
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, 2020,
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
2021
|
|
March 31
2020
|
Revenues:
|
|
|
|
HETLIOZ® net product sales
|
$
|
39,343
|
|
|
$
|
35,336
|
|
Fanapt® net product sales
|
23,326
|
|
|
22,664
|
|
Total
revenues
|
62,669
|
|
|
58,000
|
|
Operating
expenses:
|
|
|
|
Cost of goods sold
excluding amortization
|
6,030
|
|
|
5,207
|
|
Research and
development
|
16,131
|
|
|
15,527
|
|
Selling, general and
administrative
|
29,797
|
|
|
37,021
|
|
Intangible asset
amortization
|
370
|
|
|
370
|
|
Total operating
expenses
|
52,328
|
|
|
58,125
|
|
Income (loss) from
operations
|
10,341
|
|
|
(125)
|
|
Other
income
|
87
|
|
|
1,366
|
|
Income before income
taxes
|
10,428
|
|
|
1,241
|
|
Provision for income
taxes
|
1,778
|
|
|
755
|
|
Net income
|
$
|
8,650
|
|
|
$
|
486
|
|
Net income per share,
basic
|
$
|
0.16
|
|
|
$
|
0.01
|
|
Net income per share,
diluted
|
$
|
0.15
|
|
|
$
|
0.01
|
|
Weighted average
shares outstanding, basic
|
55,145,789
|
|
|
53,806,317
|
|
Weighted average
shares outstanding, diluted
|
56,505,087
|
|
|
54,870,146
|
|
VANDA
PHARMACEUTICALS INC.
|
CONDENSED
CONSOLIDATED BALANCE SHEETS
|
(in
thousands)
|
(unaudited)
|
|
|
March 31
2021
|
|
December 31
2020
|
ASSETS
|
|
|
|
Current
assets:
|
|
|
|
Cash and cash
equivalents
|
$
|
72,132
|
|
|
$
|
61,031
|
|
Marketable
securities
|
306,030
|
|
|
306,709
|
|
Accounts receivable,
net
|
31,474
|
|
|
30,036
|
|
Inventory
|
1,361
|
|
|
1,280
|
|
Prepaid expenses and
other current assets
|
10,227
|
|
|
10,089
|
|
Total current
assets
|
421,224
|
|
|
409,145
|
|
Property and
equipment, net
|
3,840
|
|
|
4,136
|
|
Operating lease
right-of-use assets
|
10,194
|
|
|
10,459
|
|
Intangible assets,
net
|
21,189
|
|
|
21,559
|
|
Deferred tax
assets
|
80,355
|
|
|
81,516
|
|
Non-current inventory
and other
|
6,389
|
|
|
6,641
|
|
Total
assets
|
$
|
543,191
|
|
|
$
|
533,456
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
Current
liabilities:
|
|
|
|
Accounts payable and
accrued liabilities
|
$
|
26,105
|
|
|
$
|
31,509
|
|
Product revenue
allowances
|
35,679
|
|
|
34,427
|
|
Total current
liabilities
|
61,784
|
|
|
65,936
|
|
Operating lease
non-current liabilities
|
11,125
|
|
|
11,497
|
|
Other non-current
liabilities
|
2,655
|
|
|
2,757
|
|
Total
liabilities
|
75,564
|
|
|
80,190
|
|
Stockholders'
equity:
|
|
|
|
Common
stock
|
56
|
|
|
55
|
|
Additional paid-in
capital
|
656,057
|
|
|
650,300
|
|
Accumulated other
comprehensive income
|
192
|
|
|
239
|
|
Accumulated
deficit
|
(188,678)
|
|
|
(197,328)
|
|
Total stockholders'
equity
|
467,627
|
|
|
453,266
|
|
Total liabilities and
stockholders' equity
|
$
|
543,191
|
|
|
$
|
533,456
|
|
Corporate Contact:
AJ Jones II
Chief Corporate Affairs and Communications Officer
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.