WASHINGTON, May 6, 2020 /PRNewswire/ -- Vanda
Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced
financial and operational results for the first quarter ended
March 31, 2020.
"Our strong financial performance in the first quarter well
positions Vanda to continue to innovate and serve our patients,
even during this deadly pandemic," said Mihael H. Polymeropoulos, M.D., Vanda's
President and CEO.
Key Financial and Corporate
Highlights
- Total revenues from HETLIOZ® and Fanapt®
were $58.0 million in the first
quarter of 2020, a 22% increase compared to $47.7 million in the first quarter of 2019.
- HETLIOZ® net product sales were $35.3 million in the first quarter of 2020, a 22%
increase compared to $29.0 million in
the first quarter of 2019.
- Fanapt® net product sales were $22.7 million in the first quarter of 2020, a 21%
increase compared to $18.8 million in
the first quarter of 2019.
- Cash, cash equivalents and marketable securities (Cash) were
$312.3 million as of March 31, 2020, representing an increase to Cash
of $44.5 million compared to
March 31, 2019.
- Net income was $0.5 million for
the first quarter of 2020, compared to a net loss of $0.6 million for the first quarter of 2019.
Key Product and Pipeline Highlights
Vanda is working proactively across its business and research
units to protect employees and customers, and to maintain business
continuity as a result of the COVID-19 pandemic.
Products
Vanda is encouraged by the strong performance of its commercial
products during the first quarter of 2020, driving 22%
year-over-year growth. Vanda is implementing marketing and sales
strategies aimed at overcoming the disruptions caused by the
pandemic. Vanda remains committed to continue innovating and
bringing value to patients and prescribers, while advancing and
strengthening the awareness and use of its products.
Pipeline
The COVID-19 pandemic has impacted clinical research globally,
including Vanda's previously reported clinical trials. New
recruitment for the tradipitant atopic dermatitis, gastroparesis
and motion sickness programs, as well as the HETLIOZ®
delayed sleep phase disorder study and Fanapt® bipolar
disorder and long acting injectable studies, is currently on
hold.
Tradipitant
- The ongoing atopic dermatitis and gastroparesis studies have
been adapted in accordance with U.S. Food and Drug Administration
(FDA) guidance to protect the health and safety of currently
enrolled patients and healthcare providers.
- The results of the recent atopic dermatitis (EPIONE),
gastroparesis (VLY686-2301) and motion sickness (Motion Sifnos)
studies have all been submitted to peer-review publications.
- See below for details on Vanda's clinical study, ODYSSEY
VLY-686-3501, for the treatment of patients with COVID-19 Acute
Respiratory Distress Syndrome (ARDS).
HETLIOZ® (tasimelteon)
- Discussions with the FDA are ongoing regarding the supplemental
New Drug Applications for HETLIOZ® in the treatments of
jet lag disorder and Smith-Magenis Syndrome.
COVID-19 Therapeutic Program
Vanda initiated the following activities aimed at combating
COVID-19:
- Vanda announced the initiation of ODYSSEY VLY-686-3501, a Phase
III double-blind placebo-controlled trial investigating the
efficacy and safety of tradipitant for the treatment of patients
with COVID-19 ARDS. Results of this study are expected in the third
quarter of 2020.
- Vanda also announced the initiation of the CALYPSO genetics
study to evaluate the role of human and viral genetic variations in
COVID-19 infection and disease severity.
- Vanda and the University of Illinois at
Chicago (UIC) announced a research partnership to identify
small molecule inhibitors of cathepsin-L, a host enzyme required
for viral processing.
GAAP Financial Results
Net income was $0.5 million for
the first quarter of 2020, compared to a net loss of $0.6 million for the first quarter of
2019. Diluted net income per share was $0.01 in the first quarter of 2020, compared to a
diluted net loss per share of $0.01
in the first quarter of 2019.
2020 Financial Guidance
Vanda will continue to assess the impact of the rapidly evolving
COVID-19 pandemic on its business and operations and will provide
future updates to its financial guidance as necessary. The
financial guidance communicated by Vanda as of February 25, 2020 is shown below.
Full Year
2020
Financial
Objectives
|
Full Year
2020
Guidance
|
Total
revenues
|
$240 to $260
million
|
HETLIOZ®
net product sales
|
$155 to $165
million
|
Fanapt®
net product sales
|
$85 to $95
million
|
Year-end 2020
Cash
|
Greater than $320
million
|
Conference Call
Vanda has scheduled a conference call for today, Wednesday, May 6, 2020, at 4:30 PM ET. During the call, Vanda's management
will discuss the first quarter 2020 financial results and other
corporate activities. Investors can call 1-866-688-9426 (domestic)
or 1-409-216-0816 (international) and use passcode 2583625. A
replay of the call will be available on Wednesday, May 6, 2020, beginning at 7:30 PM ET and will be accessible until
Wednesday, May 13, 2020 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 2583625.
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.
CAUTIONARY NOTE REGARDING FORWARD LOOKING
STATEMENTS
Various statements in this release, including,
but not limited to, the guidance provided under "2020 Financial
Guidance" above and statements regarding Vanda's ODYSSEY study, its
collaboration with the UIC and its clinical development programs
for tradipitant, HETLIOZ® and Fanapt®, are
"forward-looking statements" under the securities laws.
Forward-looking statements are based upon current expectations that
involve risks, changes in circumstances, assumptions 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 maintain business continuity during the global COVID-19
pandemic and related market volatility; the duration and severity
of the global COVID-19 pandemic, including prevailing economic
conditions and general uncertainties relating thereto that may be
unknown and unforeseeable; the ability of Vanda and the UIC to
identify small molecule inhibitors of cathepsin-L; Vanda's ability
to enroll patients in and complete its ODYSSEY study; a failure of
tradipitant to be demonstrably safe and effective in the treatment
of COVID-19 ARDS; Vanda's ability to complete the clinical
development and obtain regulatory approval for tradipitant in the
treatment of COVID-19 ARDS, atopic dermatitis, gastroparesis and
motion sickness; Vanda's ability to successfully resume the
clinical programs that are currently on hold; and other factors
that are described in the "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, 2019,
which is on file with the SEC and available on the SEC's website
at www.sec.gov. Additional factors may be described in those
sections of Vanda's quarterly report on Form 10-Q for the quarter
ended March 31, 2020, to be filed
with the SEC in the second quarter of 2020. In addition to the
risks described above and in Vanda's annual report on Form 10-K and
quarterly reports on Form 10-Q, other unknown or unpredictable
factors also could affect Vanda's results. There can be no
assurance that the actual 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.
Therefore, no assurance can be given that the outcomes stated in
such forward-looking statements and estimates will be achieved.
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 release is provided
only as of the date of this 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.
VANDA
PHARMACEUTICALS INC.
|
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
|
(in thousands,
except for share and per share amounts)
|
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended
|
|
|
|
|
|
|
|
March
31
|
|
March
31
|
|
|
|
|
|
|
|
2020
|
|
2019
|
|
Revenues:
|
|
|
|
|
|
|
|
|
|
|
HETLIOZ®product sales, net
|
|
|
$
|
35,336
|
|
$
|
28,957
|
|
|
Fanapt®product sales, net
|
|
|
|
22,664
|
|
|
18,756
|
|
|
|
Total
revenues
|
|
|
|
|
58,000
|
|
|
47,713
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
Cost of goods sold
excluding amortization
|
|
|
5,207
|
|
|
5,113
|
|
|
Research and
development
|
|
|
|
15,527
|
|
|
13,278
|
|
|
Selling, general and
administrative
|
|
|
|
37,021
|
|
|
31,029
|
|
|
Intangible asset
amortization
|
|
|
|
370
|
|
|
380
|
|
|
|
Total operating
expenses
|
|
|
|
58,125
|
|
|
49,800
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from
operations
|
|
|
|
|
(125)
|
|
|
(2,087)
|
|
|
Other
income
|
|
|
|
|
1,366
|
|
|
1,485
|
|
Income (loss) before
income taxes
|
|
|
|
1,241
|
|
|
(602)
|
|
|
Provision for income
taxes
|
|
|
|
755
|
|
|
10
|
|
Net income
(loss)
|
|
|
|
$
|
486
|
|
$
|
(612)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) per
share, basic
|
|
|
$
|
0.01
|
|
$
|
(0.01)
|
|
Net income (loss) per
share, diluted
|
|
|
$
|
0.01
|
|
$
|
(0.01)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average
shares outstanding, basic
|
|
|
53,806,317
|
|
|
52,752,774
|
|
Weighted average
shares outstanding, diluted
|
|
|
54,870,146
|
|
|
52,752,774
|
|
VANDA
PHARMACEUTICALS INC.
|
CONDENSED
CONSOLIDATED BALANCE SHEETS
|
|
|
|
|
|
|
(in
thousands)
|
|
|
|
|
|
|
|
|
|
|
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31
2020
|
|
December 31
2019
|
|
ASSETS
|
|
|
|
|
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
|
$
|
64,950
|
|
$
|
45,072
|
|
|
Marketable
securities
|
|
|
|
|
247,376
|
|
|
267,057
|
|
|
Accounts receivable,
net
|
|
|
|
29,272
|
|
|
26,367
|
|
|
Inventory
|
|
|
|
|
|
1,320
|
|
|
1,140
|
|
|
Prepaid expenses and
other current assets
|
|
|
17,828
|
|
|
14,500
|
|
|
|
Total current
assets
|
|
|
|
|
360,746
|
|
|
354,136
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Property and
equipment, net
|
|
|
|
3,877
|
|
|
3,864
|
|
Operating lease
right-of-use assets
|
|
|
10,875
|
|
|
11,180
|
|
Intangible assets,
net
|
|
|
|
|
22,667
|
|
|
23,037
|
|
Deferred tax
assets
|
|
|
|
|
86,641
|
|
|
87,680
|
|
Non-current inventory
and other
|
|
|
|
3,719
|
|
|
3,851
|
|
|
|
Total
assets
|
|
|
|
$
|
488,525
|
|
$
|
483,748
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
|
|
|
|
Accounts payable and
accrued liabilities
|
|
$
|
26,045
|
|
$
|
27,590
|
|
|
Product revenue
allowances
|
|
|
|
33,177
|
|
|
31,915
|
|
|
|
Total current
liabilities
|
|
|
|
59,222
|
|
|
59,505
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating lease
non-current liabilities
|
|
|
|
12,139
|
|
|
12,455
|
|
|
Other non-current
liabilities
|
|
|
|
778
|
|
|
843
|
|
|
|
Total
liabilities
|
|
|
|
|
72,139
|
|
|
72,803
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders'
equity:
|
|
|
|
|
|
|
|
|
|
|
Common
stock
|
|
|
|
|
54
|
|
|
54
|
|
|
Additional paid-in
capital
|
|
|
|
|
635,730
|
|
|
631,307
|
|
|
Accumulated other
comprehensive income
|
|
|
781
|
|
|
249
|
|
|
Accumulated
deficit
|
|
|
|
|
(220,179)
|
|
|
(220,665)
|
|
|
|
Total stockholders'
equity
|
|
|
|
416,386
|
|
|
410,945
|
|
|
|
Total liabilities and
stockholders' equity
|
|
$
|
488,525
|
|
$
|
483,748
|
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.