WASHINGTON, July 28, 2021 /PRNewswire/ -- Vanda
Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced
financial and operational results for the second quarter ended
June 30, 2021.
"Vanda had another outstanding quarter of commercial revenue
growth as we resumed activity across a number of our clinical
programs. Our tradipitant in gastroparesis program is nearing
completion, bringing us closer to a much-needed new treatment
option for patients with gastroparesis and a potentially
transformational commercial opportunity for Vanda," said
Mihael H. Polymeropoulos, M.D.,
Vanda's President, CEO and Chairman of the Board.
Financial Highlights
Second Quarter of 2021
- Total net product sales from HETLIOZ® and
Fanapt® were $67.9 million
in the second quarter of 2021, a 9% increase compared to
$62.2 million in the second quarter
of 2020.
- HETLIOZ® net product sales were $44.5 million in the second quarter of 2021, a 7%
increase compared to $41.6 million in
the second quarter of 2020.
- Fanapt® net product sales were $23.4 million in the second quarter of 2021, a
13% increase compared to $20.6
million in the second quarter of 2020.
- Income before taxes was $12.6
million in the second quarter of 2021 compared to
$11.1 million in the second quarter
of 2020.
First Six Months of 2021
- Total net product sales from HETLIOZ® and
Fanapt® were $130.6
million in the first six months of 2021, a 9% increase
compared to $120.2 million in the
first six months of 2020.
- HETLIOZ® net product sales were $83.9 million in the first six months of 2021, a
9% increase compared to $76.9 million
in the first six months of 2020.
- Fanapt® net product sales were $46.7 million in the first six months of 2021, an
8% increase compared to $43.3 million
in the first six months of 2020.
- Income before taxes was $23.0
million in the first six months of 2021 compared to
$12.3 million in the first six months
of 2020.
- Cash, cash equivalents and marketable securities (Cash) was
$396.5 million as of June 30, 2021, representing an increase to Cash
of $56.6 million compared to
June 30, 2020.
Key Operational Highlights
Tradipitant
- The Phase III clinical study of tradipitant in gastroparesis is
nearing completion with 95% of the target 200 patients already
enrolled. Results are expected by the end of 2021.
HETLIOZ® (tasimelteon)
- A Phase III clinical study of HETLIOZ® in delayed
sleep phase disorder (DSPD) is currently enrolling patients.
Fanapt® (iloperidone)
- A Phase III clinical study of Fanapt® in bipolar
disorder is currently enrolling patients.
- A clinical pharmacology study of the long acting injectable
(LAI) formulation of Fanapt® is ongoing.
Key Publications
- The article "Tasimelteon safely and effectively improves sleep
in Smith–Magenis syndrome: a double-blind randomized trial followed
by an open-label extension" was published in July 2021 in Genetics in
Medicine.1
GAAP Financial Results
Income before taxes was $12.6
million in the second quarter of 2021 compared to
$11.1 million in the second quarter
of 2020. Net income was $9.7 million
in the second quarter of 2021 compared to net income of
$8.7 million in the second quarter of
2020. Diluted net income per share was $0.17 in the second quarter of 2021 compared to
diluted net income per share of $0.16
in the second quarter of 2020.
Income before taxes was $23.0
million in the first six months of 2021 compared to
$12.3 million in the first six months
of 2020. Net income was $18.3 million
in the first six months of 2021 compared to net income of
$9.2 million in the first six months
of 2020. Diluted net income per share was $0.32 in the first six months of 2021 compared to
diluted net income per share of $0.17
in the first six months 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, July 28, 2021, at 4:30 PM ET. During the call, Vanda's management
will discuss the second 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 5298904. A
replay of the call will be available on Wednesday, July 28, 2021, beginning at
7:30 PM ET and will be accessible
until Wednesday, August 4, 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 5298904.
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
- Polymeropoulos, C.M., Brooks, J., Czeisler, E.L., Fisher, M.A.,
Gibson, M.M., Kite, K., Smieszek, S.P., Xiao, C., Elsea, S.H.,
Birznieks, G., Polymeropoulos, M.H. (2021). Tasimelteon safely and
effectively improves sleep in Smith–Magenis syndrome: a
double-blind randomized trial followed by an open-label extension.
Genetics in Medicine.
https://doi.org/10.1038/s41436-021-01282-y
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 and commercial potential 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., Vanda's
ability to complete the clinical development and obtain regulatory
approval for tradipitant in the treatment of gastroparesis, the
prevalence of gastroparesis and Vanda's ability to successfully
commercialize tradipitant. 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
|
|
Six Months
Ended
|
|
June 30
2021
|
|
June 30
2020
|
|
June 30
2021
|
|
June 30
2020
|
|
Revenues:
|
|
|
|
|
|
|
|
|
HETLIOZ® net product sales
|
$
|
44,509
|
|
|
$
|
41,561
|
|
|
$
|
83,852
|
|
|
$
|
76,897
|
|
|
Fanapt® net product sales
|
23,390
|
|
|
20,646
|
|
|
46,716
|
|
|
43,310
|
|
|
Total
revenues
|
67,899
|
|
|
62,207
|
|
|
130,568
|
|
|
120,207
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
Cost of goods sold
excluding amortization
|
6,566
|
|
|
5,847
|
|
|
12,596
|
|
|
11,054
|
|
|
Research and
development
|
20,248
|
|
|
12,903
|
|
|
36,379
|
|
|
28,430
|
|
|
Selling, general and
administrative
|
28,347
|
|
|
33,917
|
|
|
58,144
|
|
|
70,938
|
|
|
Intangible asset
amortization
|
369
|
|
|
369
|
|
|
739
|
|
|
739
|
|
|
Total operating
expenses
|
55,530
|
|
|
53,036
|
|
|
107,858
|
|
|
111,161
|
|
|
Income from
operations
|
12,369
|
|
|
9,171
|
|
|
22,710
|
|
|
9,046
|
|
|
Other
income
|
235
|
|
|
1,918
|
|
|
322
|
|
|
3,284
|
|
|
Income before income
taxes
|
12,604
|
|
|
11,089
|
|
|
23,032
|
|
|
12,330
|
|
|
Provision for income
taxes
|
2,951
|
|
|
2,375
|
|
|
4,729
|
|
|
3,130
|
|
|
Net income
|
$
|
9,653
|
|
|
$
|
8,714
|
|
|
$
|
18,303
|
|
|
$
|
9,200
|
|
|
Net income per share,
basic
|
$
|
0.17
|
|
|
$
|
0.16
|
|
|
$
|
0.33
|
|
|
$
|
0.17
|
|
|
Net income per share,
diluted
|
$
|
0.17
|
|
|
$
|
0.16
|
|
|
$
|
0.32
|
|
|
$
|
0.17
|
|
|
Weighted average
shares outstanding, basic
|
55,582,916
|
|
|
54,501,308
|
|
|
55,365,558
|
|
|
54,153,812
|
|
|
Weighted average
shares outstanding, diluted
|
56,903,340
|
|
|
55,081,397
|
|
|
56,705,419
|
|
|
54,975,771
|
|
|
VANDA
PHARMACEUTICALS INC.
CONDENSED CONSOLIDATED BALANCE
SHEETS
(in
thousands)
(unaudited)
|
|
|
June 30
2021
|
|
December
31
2020
|
|
ASSETS
|
|
|
|
|
Current
assets:
|
|
|
|
|
Cash and cash
equivalents
|
$
|
57,242
|
|
|
$
|
61,031
|
|
|
Marketable
securities
|
339,251
|
|
|
306,709
|
|
|
Accounts receivable,
net
|
37,090
|
|
|
30,036
|
|
|
Inventory
|
1,055
|
|
|
1,280
|
|
|
Prepaid expenses and
other current assets
|
12,014
|
|
|
10,089
|
|
|
Total current
assets
|
446,652
|
|
|
409,145
|
|
|
Property and
equipment, net
|
3,631
|
|
|
4,136
|
|
|
Operating lease
right-of-use assets
|
9,898
|
|
|
10,459
|
|
|
Intangible assets,
net
|
20,820
|
|
|
21,559
|
|
|
Deferred tax
assets
|
78,641
|
|
|
81,516
|
|
|
Non-current inventory
and other
|
8,003
|
|
|
6,641
|
|
|
Total
assets
|
$
|
567,645
|
|
|
$
|
533,456
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
Accounts payable and
accrued liabilities
|
$
|
31,788
|
|
|
$
|
31,509
|
|
|
Product revenue
allowances
|
40,201
|
|
|
34,427
|
|
|
Total current
liabilities
|
71,989
|
|
|
65,936
|
|
|
Operating lease
non-current liabilities
|
10,740
|
|
|
11,497
|
|
|
Other non-current
liabilities
|
3,696
|
|
|
2,757
|
|
|
Total
liabilities
|
86,425
|
|
|
80,190
|
|
|
Stockholders'
equity:
|
|
|
|
|
Common
stock
|
56
|
|
|
55
|
|
|
Additional paid-in
capital
|
660,086
|
|
|
650,300
|
|
|
Accumulated other
comprehensive income
|
103
|
|
|
239
|
|
|
Accumulated
deficit
|
(179,025)
|
|
|
(197,328)
|
|
|
Total stockholders'
equity
|
481,220
|
|
|
453,266
|
|
|
Total liabilities and
stockholders' equity
|
$
|
567,645
|
|
|
$
|
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.