WASHINGTON, Feb. 10, 2021 /PRNewswire/ -- Vanda
Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced
financial and operational results for the fourth quarter and full
year ended December 31, 2020.
"I am very proud of the significant accomplishments we realized
during this challenging year," said Mihael
H. Polymeropoulos, M.D., President and CEO of Vanda. "As we
look forward to the new year, it is worth noting some of our
significant accomplishments from 2020: Vanda achieved record
commercial revenue despite extraordinary difficulty in the field,
which we believe is a testament to the value our products bring to
patients; HETLIOZ® received FDA approval for nighttime
sleep disturbances in patients with Smith-Magenis Syndrome; our
tradipitant gastroparesis Phase III study continued recruitment;
the FDA approved individual Expanded Access to tradipitant for
multiple gastroparesis patients; we launched the tradipitant study
for COVID-19 pneumonia; the FDA approved the Investigational New
Drug application for VSJ-110 in allergic conjunctivitis; the United
States Supreme Court affirmed the patent ruling on
Fanapt®; and our research and development efforts
advanced the clinical programs for our commercial assets as well as
those in our pipeline. We look forward to another great year of
accomplishments, including further revenue growth, the commercial
launch of HETLIOZ® in patients with Smith-Magenis
Syndrome, and the results of the tradipitant Phase III study in
gastroparesis, to highlight a few."
Key Financial and Corporate Highlights
Fourth Quarter of 2020
- Total net product sales from HETLIOZ® and
Fanapt® were $67.7 million
in the fourth quarter of 2020, an 11% increase compared to
$60.9 million in the fourth quarter
of 2019.
- HETLIOZ® net product sales were $44.2 million in the fourth quarter of 2020, a
14% increase compared to $38.6
million in the fourth quarter of 2019.
- Fanapt® net product sales were $23.5 million in the fourth quarter of 2020, a 5%
increase compared to $22.3 million in
the fourth quarter of 2019.
- Income before taxes was $10.9
million in the fourth quarter of 2020 compared to
$5.8 million in the fourth quarter of
2019.
Full Year 2020
- Total net product sales from HETLIOZ® and
Fanapt® were $248.2
million for the full year 2020, a 9% increase compared to
$227.2 million for the full year
2019.
- HETLIOZ® net product sales were $160.7 million for the full year 2020, a 12%
increase compared to $143.0 million
for the full year 2019.
- Fanapt® net product sales were $87.5 million for the full year 2020, a 4%
increase compared to $84.2 million
for the full year 2019.
- Income before taxes was $31.7
million for the full year 2020 compared to $29.0 million for the full year 2019.
- Cash, cash equivalents and marketable securities (Cash) was
$367.7 million as of December 31, 2020, representing an increase to
Cash of $55.6 million compared to
December 31, 2019.
Key Product and Pipeline Highlights
Products
Vanda is encouraged by the strength of its commercial
performance during the fourth quarter of 2020. Vanda continues to
implement marketing and sales strategies aimed at supporting growth
and minimizing the impact of disruptions caused by the COVID-19
pandemic, including the Fanapt® for schizophrenia
direct-to-consumer campaign, which was launched in 2020. Vanda is
continuing its activities to support and facilitate the treatment
of individuals in the U.S. living with Smith-Magenis Syndrome
(SMS), and is committed to its awareness campaign and the support
of patients suffering with Non-24-Hour Sleep-Wake Disorder.
Pipeline
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 first half
of 2021, with a New Drug Application (NDA) filing projected in the
second half of 2021.
- The COVID-19 pneumonia Phase III clinical study (ODYSSEY
VLY-686-3501) is ongoing.
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 SMS.1
HETLIOZ® capsules, for adults with SMS, were immediately
available after approval and the HETLIOZ LQ™ liquid
formulation, for children with SMS, is expected to be available in
the first quarter of 2021. SMS is estimated to affect
1/15,000-25,000 births in the U.S.2 HETLIOZ®
is the first and only FDA approved medication for patients with
SMS.
- A Phase III clinical study for HETLIOZ® in delayed
sleep phase disorder (DSPD) is expected to be initiated in the
first quarter of 2021.
- A clinical development program for HETLIOZ® in
autism spectrum disorder (ASD) is expected to be initiated in the
first quarter of 2021.
Fanapt® (iloperidone)
- Development of the long acting injectable (LAI) formulation of
Fanapt® is ongoing.
- A clinical program for Fanapt® in Parkinson's
disease psychosis (PDP) is expected to begin in the first quarter
of 2021.
GAAP Financial Results
Income before taxes was $10.9
million in the fourth quarter of 2020 compared to
$5.8 million in the fourth quarter of
2019. Net income was $8.2 million in
the fourth quarter of 2020 compared to net income of $4.2 million in the fourth quarter of
2019. Diluted net income per share was $0.15 in the fourth quarter of 2020 compared to
diluted net income per share of $0.08
in the fourth quarter of 2019.
Income before taxes was $31.7
million for the full year 2020 compared to $29.0 million for the full year 2019. Net income
was $23.3 million for the full year
2020 compared to net income of $115.6
million for the full year 2019. The full year 2019 net
income of $115.6 million and the 2019
income tax benefit of $86.5 million
include the favorable impact of the release of Vanda's deferred tax
asset valuation allowance.
Diluted net income per share was $0.42 for the full year 2020 compared to diluted
net income per share of $2.11 for the
full year 2019.
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, February 10, 2021, at 4:30 PM ET. During the call, Vanda's management
will discuss the fourth quarter and full year 2020 financial
results and other corporate activities. Investors can call
1-866-688-9426 (domestic) or 1-409-216-0816 (international) and use
passcode number 3557867. A replay of the call will be available on
Wednesday, February 10, 2021,
beginning at 7:30 PM ET and will be
accessible until Wednesday, February 17,
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
3557867.
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
- Orphanet ORPHA number 819.
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 Vanda's revenue
expectations for 2021, the commercial launch of HETLIOZ®
for the treatment of patients with SMS, Vanda's marketing and sales
strategies, the expected availability of the HETLIOZ
LQTM liquid formulation and the clinical development and
regulatory timelines for tradipitant, HETLIOZ® and
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 its ability to continue to grow its business
in the U.S., the ability of Vanda's third-party manufacturer to
timely provide Vanda with a supply of the HETLIOZ LQTM
liquid formulation, and Vanda's ability to complete the clinical
development and obtain regulatory approval for tradipitant in the
treatment of gastroparesis and COVID-19 pneumonia,
HETLIOZ® in the treatment of DSPD and ASD,
Fanapt® LAI in the treatment of schizophrenia, and
Fanapt® in the treatment of PDP. Therefore, no assurance
can be given 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.
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, 2019, 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
|
|
Twelve Months
Ended
|
|
December
31
2020
|
|
December
31
2019
|
|
December
31
2020
|
|
December
31
2019
|
Revenues:
|
|
|
|
|
|
|
|
HETLIOZ® net product sales
|
$
|
44,171
|
|
|
$
|
38,599
|
|
|
$
|
160,686
|
|
|
$
|
142,980
|
|
Fanapt® net product sales
|
23,482
|
|
|
22,331
|
|
|
87,482
|
|
|
84,208
|
|
Total
revenues
|
67,653
|
|
|
60,930
|
|
|
248,168
|
|
|
227,188
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
Cost of goods sold
excluding amortization
|
6,412
|
|
|
6,225
|
|
|
23,364
|
|
|
24,488
|
|
Research and
development
|
14,849
|
|
|
13,074
|
|
|
55,577
|
|
|
48,649
|
|
Selling, general and
administrative
|
35,571
|
|
|
37,018
|
|
|
140,510
|
|
|
129,736
|
|
Intangible asset
amortization
|
370
|
|
|
370
|
|
|
1,478
|
|
|
1,505
|
|
Total operating
expenses
|
57,202
|
|
|
56,687
|
|
|
220,929
|
|
|
204,378
|
|
Income from
operations
|
10,451
|
|
|
4,243
|
|
|
27,239
|
|
|
22,810
|
|
Other
income
|
473
|
|
|
1,567
|
|
|
4,416
|
|
|
6,218
|
|
Income before income
taxes
|
10,924
|
|
|
5,810
|
|
|
31,655
|
|
|
29,028
|
|
Provision (benefit)
for income taxes
|
2,734
|
|
|
1,594
|
|
|
8,318
|
|
|
(86,525)
|
|
Net income
|
$
|
8,190
|
|
|
$
|
4,216
|
|
|
$
|
23,337
|
|
|
$
|
115,553
|
|
Net income per share,
basic
|
$
|
0.15
|
|
|
$
|
0.08
|
|
|
$
|
0.43
|
|
|
$
|
2.17
|
|
Net income per share,
diluted
|
$
|
0.15
|
|
|
$
|
0.08
|
|
|
$
|
0.42
|
|
|
$
|
2.11
|
|
Weighted average
shares outstanding, basic
|
54,731,042
|
|
|
53,389,950
|
|
|
54,427,683
|
|
|
53,137,562
|
|
Weighted average
shares outstanding, diluted
|
55,596,697
|
|
|
54,973,952
|
|
|
55,190,802
|
|
|
54,847,060
|
|
VANDA
PHARMACEUTICALS INC. CONDENSED CONSOLIDATED BALANCE
SHEETS (in
thousands) (unaudited)
|
|
|
December
31
2020
|
|
December
31
2019
|
ASSETS
|
|
|
|
Current
assets:
|
|
|
|
Cash and cash
equivalents
|
$
|
61,031
|
|
|
$
|
45,072
|
|
Marketable
securities
|
306,709
|
|
|
267,057
|
|
Accounts receivable,
net
|
30,036
|
|
|
26,367
|
|
Inventory
|
1,280
|
|
|
1,140
|
|
Prepaid expenses and
other current assets
|
10,089
|
|
|
14,500
|
|
Total current
assets
|
409,145
|
|
|
354,136
|
|
Property and
equipment, net
|
4,136
|
|
|
3,864
|
|
Operating lease
right-of-use assets
|
10,459
|
|
|
11,180
|
|
Intangible assets,
net
|
21,559
|
|
|
23,037
|
|
Deferred tax
assets
|
81,516
|
|
|
87,680
|
|
Non-current inventory
and other
|
6,641
|
|
|
3,851
|
|
Total
assets
|
$
|
533,456
|
|
|
$
|
483,748
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
Current
liabilities:
|
|
|
|
Accounts payable and
accrued liabilities
|
$
|
31,509
|
|
|
$
|
27,590
|
|
Product revenue
allowances
|
34,427
|
|
|
31,915
|
|
Total current
liabilities
|
65,936
|
|
|
59,505
|
|
Operating lease
non-current liabilities
|
11,497
|
|
|
12,455
|
|
Other non-current
liabilities
|
2,757
|
|
|
843
|
|
Total
liabilities
|
80,190
|
|
|
72,803
|
|
Stockholders'
equity:
|
|
|
|
Common
stock
|
55
|
|
|
54
|
|
Additional paid-in
capital
|
650,300
|
|
|
631,307
|
|
Accumulated other
comprehensive income
|
239
|
|
|
249
|
|
Accumulated
deficit
|
(197,328)
|
|
|
(220,665)
|
|
Total stockholders'
equity
|
453,266
|
|
|
410,945
|
|
Total liabilities and
stockholders' equity
|
$
|
533,456
|
|
|
$
|
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.