WASHINGTON, Nov. 3, 2021 /PRNewswire/ -- Vanda
Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced
financial and operational results for the third quarter ended
September 30, 2021.
"Vanda is approaching another pivotal moment in its 18-year
history with the upcoming completion of the Phase III study of
tradipitant in gastroparesis and anticipated results by the end of
this year. We believe that tradipitant has the potential to become
the first new product in 40 years for the treatment of
gastroparesis, a serious and debilitating disorder that severely
impacts the lives of many people. Additionally, the launch of
HETLIOZ® and HETLIOZ LQ™ for nighttime sleep
disturbances in people with Smith-Magenis Syndrome is progressing
well as we are beginning our broad awareness campaign. Across all
of our programs, patient access to innovative treatments remains a
key goal of Vanda. We are currently working to address the
escalating reimbursement delays for HETLIOZ®, which are
especially impacting Non-24 patients with light perception, and we
are confident in our ability to drive positive outcomes for
patients. I am proud of the Vanda team for continuing to advance
Vanda's innovation objectives and creating value for patients and
all of the company's stakeholders," said Mihael H. Polymeropoulos, M.D., Vanda's
President, CEO and Chairman of the Board.
Financial Highlights
Third Quarter of 2021
- Total net product sales from HETLIOZ® and
Fanapt® were $70.1 million
in the third quarter of 2021, a 16% increase compared to
$60.3 million in the third quarter of
2020.
- HETLIOZ® net product sales were $45.6 million in the third quarter of 2021, a 15%
increase compared to $39.6 million in
the third quarter of 2020.
- Fanapt® net product sales were $24.5 million in the third quarter of 2021, an
18% increase compared to $20.7
million in the third quarter of 2020.
- Income before taxes was $10.7
million in the third quarter of 2021 compared to
$8.4 million in the third quarter of
2020.
First Nine Months of 2021
- Total net product sales from HETLIOZ® and
Fanapt® were $200.7
million in the first nine months of 2021, an 11% increase
compared to $180.5 million in the
first nine months of 2020.
- HETLIOZ® net product sales were $129.5 million in the first nine months of 2021,
an 11% increase compared to $116.5
million in the first nine months of 2020.
- Fanapt® net product sales were $71.2 million in the first nine months of 2021,
an 11% increase compared to $64.0
million in the first nine months of 2020.
- Income before taxes was $33.8
million in the first nine months of 2021 compared to
$20.7 million in the first nine
months of 2020.
- Cash, cash equivalents and marketable securities (Cash) was
$406.0 million as of September 30, 2021, representing an increase to
Cash of $57.4 million compared to
September 30, 2020.
Net Product Sales
|
Third
Quarter
|
|
(in
thousands)
|
September
30
2021
|
|
September
30
2020
|
|
$
Change
|
|
%
Change
|
|
HETLIOZ®
net product sales
|
$
|
45,615
|
|
|
$
|
39,618
|
|
|
$
|
5,997
|
|
|
15
|
%
|
|
Fanapt®
net product sales
|
24,480
|
|
|
20,690
|
|
|
3,790
|
|
|
18
|
%
|
|
Total
revenues
|
$
|
70,095
|
|
|
$
|
60,308
|
|
|
$
|
9,787
|
|
|
16
|
%
|
|
|
|
First Nine
Months
|
|
(in
thousands)
|
September
30
2021
|
|
September
30
2020
|
|
$
Change
|
|
%
Change
|
|
HETLIOZ®
net product sales
|
$
|
129,467
|
|
|
$
|
116,515
|
|
|
$
|
12,952
|
|
|
11
|
%
|
|
Fanapt®
net product sales
|
71,196
|
|
|
64,000
|
|
|
7,196
|
|
|
11
|
%
|
|
Total
revenues
|
$
|
200,663
|
|
|
$
|
180,515
|
|
|
$
|
20,148
|
|
|
11
|
%
|
Key Operational Highlights
Tradipitant
- Enrollment of the randomized portion of the Phase III clinical
study of tradipitant in gastroparesis is complete. The randomized
portion of the study is a 12-week study of approximately 200
patients with idiopathic or diabetic gastroparesis. Results are
expected by the end of 2021. Enrollment of the open label portion
of the study is ongoing with more than 250 patients enrolled.
HETLIOZ® (tasimelteon)
- Reimbursement challenges with HETLIOZ® prescriptions
for patients with Non-24 have increased significantly. While Vanda
is working to address these challenges and is confident in its
ability to successfully navigate the current environment, Vanda is
revising its HETLIOZ® net product sales guidance to
$170 to $190
million from the prior HETLIOZ® net product sales
guidance of $180 to $200 million.
- In December 2020, the 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 To
date, more than 90 patients with SMS have been prescribed
HETLIOZ® or HETLIOZ LQ™ and a broad awareness campaign
is expected to begin during the fourth quarter of 2021.
- A Phase III clinical study of HETLIOZ® in delayed
sleep phase disorder (DSPD) is currently enrolling patients. The
study has a 28-day randomized evaluation period and plans to enroll
approximately 300 patients. DSPD is likely the most prevalent
circadian-rhythm sleep disorder, affecting approximately 1% of the
population, and there is no FDA approved treatment at this
time.2
Fanapt® (iloperidone)
- A Phase III clinical study of Fanapt® in acute
bipolar mania disorder is currently enrolling. The study is a
placebo controlled four-week evaluation of approximately 400
patients at sites in the U.S. and Europe.
- A repeat-dose clinical pharmacology study of the long acting
injectable (LAI) formulation of Fanapt® is ongoing. A
Phase III study of the LAI formulation for the treatment of acute
schizophrenia is planned to follow the pharmacology study.
- Evaluation of P88, the active metabolite of iloperidone, has
been initiated. P88 has the potential to improve the clinical
profile of Fanapt® and create sustained, long-term value
in the treatment of psychiatric disorders.
GAAP Financial Results
Income before taxes was $10.7
million in the third quarter of 2021 compared to
$8.4 million in the third quarter of
2020. Net income was $7.8 million in
the third quarter of 2021 compared to net income of $5.9 million in the third quarter of
2020. Diluted net income per share was $0.14 in the third quarter of 2021 compared to
diluted net income per share of $0.11
in the third quarter of 2020.
Income before taxes was $33.8
million in the first nine months of 2021 compared to
$20.7 million in the first nine
months of 2020. Net income was $26.1
million in the first nine months of 2021 compared to net
income of $15.1 million in the first
nine months of 2020. Diluted net income per share was
$0.46 in the first nine months of
2021 compared to diluted net income per share of $0.28 in the first nine months of 2020.
2021 Financial Guidance
Vanda is updating its 2021 financial guidance and expects to
achieve the following financial objectives in 2021:
|
Full Year
2021
Financial
Objectives
|
Revised Full Year
2021
Guidance
|
Prior Full Year
2021
Guidance
|
|
|
Total
revenues
|
$260 to $290
million
|
$270 to $300
million
|
|
|
HETLIOZ®
net product sales
|
$170 to $190
million
|
$180 to $200
million
|
|
|
Fanapt®
net product sales
|
$90 to $100
million
|
$90 to $100
million
|
|
|
Year-end 2021
Cash
|
Greater than $400
million
|
Greater than $400
million
|
|
Conference Call
Vanda has scheduled a conference call for today, Wednesday, November 3, 2021, at 4:30 PM ET. During the call, Vanda's management
will discuss the third 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 5961858. A
replay of the call will be available on Wednesday, November 3, 2021, beginning at
7:30 PM ET and will be accessible
until Wednesday, November 10, 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 5961858.
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
- P.J. Murphy, Delayed Sleep-Phase Type, Encyclopedia of
Sleep, Academic Press, 2013, Pages 22-25, ISBN 9780123786111,
https://doi.org/10.1016/B978-0-12-378610-4.00268-0
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 timelines for tradipitant and Fanapt® LAI,
the therapeutic and commercial potential of tradipitant and P88,
and Vanda's ability to address reimbursement challenges 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 for tradipitant in the
treatment of gastroparesis and Fanapt® LAI in the
treatment of acute schizophrenia, Vanda's ability to obtain
regulatory approval of tradipitant in the treatment of
gastroparesis, the ability of P88 to improve the clinical profile
of Fanapt®, and Vanda's ability to improve patient
access to HETLIOZ®. 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
|
|
Nine Months
Ended
|
|
September
30
2021
|
|
September
30
2020
|
|
September
30
2021
|
|
September
30
2020
|
|
Revenues:
|
|
|
|
|
|
|
|
|
HETLIOZ®
net product sales
|
$
|
45,615
|
|
|
$
|
39,618
|
|
|
$
|
129,467
|
|
|
$
|
116,515
|
|
|
Fanapt® net
product sales
|
24,480
|
|
|
20,690
|
|
|
71,196
|
|
|
64,000
|
|
|
Total
revenues
|
70,095
|
|
|
60,308
|
|
|
200,663
|
|
|
180,515
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
Cost of goods sold
excluding amortization
|
6,797
|
|
|
5,898
|
|
|
19,393
|
|
|
16,952
|
|
|
Research and
development
|
19,653
|
|
|
12,298
|
|
|
56,032
|
|
|
40,728
|
|
|
Selling, general and
administrative
|
32,456
|
|
|
34,001
|
|
|
90,600
|
|
|
104,939
|
|
|
Intangible asset
amortization
|
370
|
|
|
369
|
|
|
1,109
|
|
|
1,108
|
|
|
Total operating
expenses
|
59,276
|
|
|
52,566
|
|
|
167,134
|
|
|
163,727
|
|
|
Income from
operations
|
10,819
|
|
|
7,742
|
|
|
33,529
|
|
|
16,788
|
|
|
Other income
(expense)
|
(97)
|
|
|
659
|
|
|
225
|
|
|
3,943
|
|
|
Income before income
taxes
|
10,722
|
|
|
8,401
|
|
|
33,754
|
|
|
20,731
|
|
|
Provision for income
taxes
|
2,951
|
|
|
2,454
|
|
|
7,680
|
|
|
5,584
|
|
|
Net income
|
$
|
7,771
|
|
|
$
|
5,947
|
|
|
$
|
26,074
|
|
|
$
|
15,147
|
|
|
Net income per share,
basic
|
$
|
0.14
|
|
|
$
|
0.11
|
|
|
$
|
0.47
|
|
|
$
|
0.28
|
|
|
Net income per share,
diluted
|
$
|
0.14
|
|
|
$
|
0.11
|
|
|
$
|
0.46
|
|
|
$
|
0.28
|
|
|
Weighted average
shares outstanding, basic
|
55,668,156
|
|
|
54,666,128
|
|
|
55,467,528
|
|
|
54,325,832
|
|
|
Weighted average
shares outstanding, diluted
|
57,040,736
|
|
|
55,209,032
|
|
|
56,818,295
|
|
|
55,054,772
|
|
|
VANDA
PHARMACEUTICALS INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS
(in
thousands)
(unaudited)
|
|
September
30
2021
|
|
December
31
2020
|
|
ASSETS
|
|
|
|
|
Current
assets:
|
|
|
|
|
Cash and cash
equivalents
|
$
|
50,522
|
|
|
$
|
61,031
|
|
|
Marketable
securities
|
355,446
|
|
|
306,709
|
|
|
Accounts receivable,
net
|
41,496
|
|
|
30,036
|
|
|
Inventory
|
902
|
|
|
1,280
|
|
|
Prepaid expenses and
other current assets
|
13,442
|
|
|
10,089
|
|
|
Total current
assets
|
461,808
|
|
|
409,145
|
|
|
Property and
equipment, net
|
3,318
|
|
|
4,136
|
|
|
Operating lease
right-of-use assets
|
9,580
|
|
|
10,459
|
|
|
Intangible assets,
net
|
20,450
|
|
|
21,559
|
|
|
Deferred tax
assets
|
76,105
|
|
|
81,516
|
|
|
Non-current inventory
and other
|
8,506
|
|
|
6,641
|
|
|
Total
assets
|
$
|
579,767
|
|
|
$
|
533,456
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
Accounts payable and
accrued liabilities
|
$
|
31,820
|
|
|
$
|
31,509
|
|
|
Product revenue
allowances
|
40,177
|
|
|
34,427
|
|
|
Total current
liabilities
|
71,997
|
|
|
65,936
|
|
|
Operating lease
non-current liabilities
|
10,457
|
|
|
11,497
|
|
|
Other non-current
liabilities
|
3,992
|
|
|
2,757
|
|
|
Total
liabilities
|
86,446
|
|
|
80,190
|
|
|
Stockholders'
equity:
|
|
|
|
|
Common
stock
|
56
|
|
|
55
|
|
|
Additional paid-in
capital
|
664,408
|
|
|
650,300
|
|
|
Accumulated other
comprehensive income
|
111
|
|
|
239
|
|
|
Accumulated
deficit
|
(171,254)
|
|
|
(197,328)
|
|
|
Total stockholders'
equity
|
493,321
|
|
|
453,266
|
|
|
Total liabilities and
stockholders' equity
|
$
|
579,767
|
|
|
$
|
533,456
|
|
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
View original
content:https://www.prnewswire.com/news-releases/vanda-pharmaceuticals-reports-third-quarter-2021-financial-results-301415740.html
SOURCE Vanda Pharmaceuticals Inc.