- Q2 2022 total revenues were $64.4
million
- Total revenues in the first six months of 2022 were
$124.6 million
- Vanda provides update on pipeline advancements and upcoming
milestones
WASHINGTON, Aug. 3, 2022
/PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA)
today announced financial and operational results for the second
quarter ended June 30, 2022.
"During the second quarter we made significant progress towards
commercializing our products and improving access to
HETLIOZ® for patients with Non-24," said Mihael H. Polymeropoulos, M.D., Vanda's
President, CEO and Chairman of the Board. "We advanced our clinical
pipeline, with significant clinical milestones expected in the
coming quarters, and we are preparing our NDA for tradipitant in
gastroparesis and our sNDA for HETLIOZ® in
insomnia."
Financial Highlights
Second Quarter of 2022
- Total net product sales from HETLIOZ® and
Fanapt® were $64.4 million
in the second quarter of 2022, a 5% decrease compared to
$67.9 million in the second quarter
of 2021.
- HETLIOZ® net product sales were $41.2 million in the second quarter of 2022, a 7%
decrease compared to $44.5 million in
the second quarter of 2021, due in part to continued reimbursement
challenges for prescriptions for patients with Non-24.
- Fanapt® net product sales were $23.2 million in the second quarter of 2022, a 1%
decrease compared to $23.4 million in
the second quarter of 2021.
- Net income was $2.6 million in
the second quarter of 2022 compared to $9.7
million in the second quarter of 2021.
First Six Months of 2022
- Total net product sales from HETLIOZ® and
Fanapt® were $124.6
million in the first six months of 2022, a 5% decrease
compared to $130.6 million in the
first six months of 2021.
- HETLIOZ® net product sales were $78.2 million in the first six months of 2022, a
7% decrease compared to $83.9 million
in the first six months of 2021, due in part to continued
reimbursement challenges for prescriptions for patients with
Non-24.
- Fanapt® net product sales were $46.4 million in the first six months of 2022, a
1% decrease compared to $46.7 million
in the first six months of 2021.
- Net loss was $3.9 million in the
first six months of 2022 compared to net income of $18.3 million in the first six months of
2021.
- Cash, cash equivalents and marketable securities (Cash) was
$440.9 million as of June 30, 2022, representing an increase to Cash
of $44.4 million compared to
June 30, 2021.
Key Operational Highlights
HETLIOZ® (tasimelteon)
- Clinical trials for HETLIOZ® in delayed sleep phase
disorder (DSPD) and sleep disturbances in autism spectrum disorder
(ASD) are currently enrolling patients.
- Vanda is preparing for the submission of a supplemental New
Drug Application (sNDA) for HETLIOZ® in the treatment of
insomnia.
- Since November 2021, more than 15
states have revised or agreed to revise their Medicaid prior
authorization criteria to broaden access to HETLIOZ® for
patients with Non-24 and patients with nighttime sleep disturbances
in Smith-Magenis Syndrome (SMS).
- In July 2022, an Administrative
Law Judge struck down a Medicare Part D plan policy that blocked
HETLIOZ® coverage for sighted Non-24 patients. Vanda
intends to advocate with other Part D plans to challenge similar
policies and improve HETLIOZ® access for Non-24
patients.
- In January 2022, Vanda settled
its HETLIOZ® patent litigation against one of the
Abbreviated New Drug Application (ANDA) defendants. The trial for
the consolidated lawsuit against the remaining defendants was held
in March 2022. A decision is expected
from the court by the end of 2022.
Tradipitant
- Vanda is continuing to conduct an open-label safety study for
tradipitant in gastroparesis and continues to receive requests from
patients seeking access to tradipitant through the Expanded Access
program that has multiple patients who have taken tradipitant for
more than a year.
- Vanda recently held a pre-NDA meeting with the U.S. Food and
Drug Administration (FDA) to discuss the planned New Drug
Application (NDA) submission for tradipitant in the short-term
treatment of nausea in gastroparesis. Vanda is preparing for the
submission of the NDA for this indication.
- The Phase III study of tradipitant in the treatment of motion
sickness is approximately 30% enrolled.
Fanapt® (iloperidone)
- Enrollment of the Phase III clinical study of
Fanapt® in acute manic episodes in patients with bipolar
disorder is close to being fully enrolled. The study is a placebo
controlled four-week evaluation of approximately 400 patients at
sites in the U.S. and Europe.
Results are expected by the end of 2022.
VQW-765
- The Phase II clinical study of a single-dose treatment of
VQW-765 to alleviate social/performance anxiety is fully enrolled.
Results are expected by the end of 2022.
GAAP Financial Results
Net income was $2.6 million in the
second quarter of 2022 compared to net income of $9.7 million in the second quarter of
2021. Diluted net income per share was $0.05 in the second quarter of 2022 compared to
diluted net income per share of $0.17
in the second quarter of 2021.
Net loss was $3.9 million in the
first six months of 2022 compared to net income of $18.3 million in the first six months of 2021.
Diluted net loss per share was $0.07
in the first six months of 2022 compared to diluted net income per
share of $0.32 in the first six
months of 2021.
2022 Financial Guidance
Vanda expects to achieve the following financial objectives in
2022:
Full Year
2022
Financial
Objectives
|
Full Year
2022
Guidance
|
Total
revenues
|
$240 to $280
million
|
HETLIOZ® net
product sales
|
$150 to $180
million
|
Fanapt® net
product sales
|
$90 to $100
million
|
Year-end 2022
Cash
|
Greater than $440
million
|
Conference Call
Vanda has scheduled a conference call for today, Wednesday, August 3, 2022, at 4:30 PM ET. During the call, Vanda's management
will discuss the second quarter 2022 financial results and other
corporate activities. Investors can call 1-800-715-9871 (domestic)
or 1-646-307-1963 (international) and use passcode number 4304469.
A replay of the call will be available on Wednesday, August 3, 2022, beginning at
8:30 PM ET and will be accessible
until Wednesday, August 10, 2022 at
8:30 PM ET. The replay call-in number
is 1-800-770-2030 for domestic callers and 1-609-800-9909 for
international callers. The passcode number is 4304469.
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 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 "2022 Financial Guidance"
above and statements regarding Vanda's plans for pursuit of
regulatory approval of tradipitant in the treatment of
gastroparesis and HETLIOZ® in the treatment of insomnia,
Vanda's strategy for improving access to HETLIOZ® for
all Non-24 patients, the timing of the court's decision with
respect to the Company's HETLIOZ® patent litigation, and
the clinical development timelines for Fanapt® and
VQW-765 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 the
strength of its business in the U.S., the FDA's assessment of the
sufficiency of the data packages to be included in Vanda's planned
NDA and sNDA submissions for tradipitant and HETLIOZ®,
Vanda's ability to fully enroll and complete the Phase III clinical
study of Fanapt® in bipolar disorder and Vanda's ability
to complete the Phase II clinical study of VQW-765 in
social/performance anxiety. 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,
2021, 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
2022
|
|
June 30
2021
|
|
June 30
2022
|
|
June 30
2021
|
Revenues:
|
|
|
|
|
|
|
|
HETLIOZ® net product sales
|
$
41,188
|
|
$
44,509
|
|
$
78,219
|
|
$
83,852
|
Fanapt® net product sales
|
23,202
|
|
23,390
|
|
46,363
|
|
46,716
|
Total
revenues
|
64,390
|
|
67,899
|
|
124,582
|
|
130,568
|
Operating
expenses:
|
|
|
|
|
|
|
|
Cost of goods sold
excluding amortization
|
6,059
|
|
6,566
|
|
11,724
|
|
12,596
|
Research and
development
|
21,490
|
|
20,248
|
|
42,459
|
|
36,379
|
Selling, general and
administrative
|
33,001
|
|
28,347
|
|
73,849
|
|
58,144
|
Intangible asset
amortization
|
379
|
|
369
|
|
758
|
|
739
|
Total operating
expenses
|
60,929
|
|
55,530
|
|
128,790
|
|
107,858
|
Income (loss) from
operations
|
3,461
|
|
12,369
|
|
(4,208)
|
|
22,710
|
Other
income
|
329
|
|
235
|
|
434
|
|
322
|
Income (loss) before
income taxes
|
3,790
|
|
12,604
|
|
(3,774)
|
|
23,032
|
Provision for income
taxes
|
1,216
|
|
2,951
|
|
82
|
|
4,729
|
Net income
(loss)
|
$
2,574
|
|
$
9,653
|
|
$
(3,856)
|
|
$
18,303
|
Net income (loss) per
share, basic
|
$
0.05
|
|
$
0.17
|
|
$
(0.07)
|
|
$
0.33
|
Net income (loss) per
share, diluted
|
$
0.05
|
|
$
0.17
|
|
$
(0.07)
|
|
$
0.32
|
Weighted average shares
outstanding, basic
|
56,508,533
|
|
55,582,916
|
|
56,307,999
|
|
55,365,558
|
Weighted average shares
outstanding, diluted
|
56,821,024
|
|
56,903,340
|
|
56,307,999
|
|
56,705,419
|
VANDA PHARMACEUTICALS
INC. CONDENSED CONSOLIDATED BALANCE
SHEETS (in
thousands) (unaudited)
|
|
|
June 30
2022
|
|
December 31
2021
|
ASSETS
|
|
|
|
Current
assets:
|
|
|
|
Cash and cash
equivalents
|
$
58,226
|
|
$
52,071
|
Marketable
securities
|
382,632
|
|
380,742
|
Accounts receivable,
net
|
28,805
|
|
32,467
|
Inventory
|
1,496
|
|
1,025
|
Prepaid expenses and
other current assets
|
25,736
|
|
11,996
|
Total current
assets
|
496,895
|
|
478,301
|
Property and equipment,
net
|
2,746
|
|
3,113
|
Operating lease
right-of-use assets
|
8,603
|
|
9,272
|
Intangible assets,
net
|
19,323
|
|
20,081
|
Deferred tax
assets
|
72,687
|
|
74,878
|
Non-current inventory
and other
|
8,848
|
|
8,147
|
Total
assets
|
$
609,102
|
|
$
593,792
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
Current
liabilities:
|
|
|
|
Accounts payable and
accrued liabilities
|
$
50,236
|
|
$
34,438
|
Product revenue
allowances
|
38,164
|
|
39,981
|
Total current
liabilities
|
88,400
|
|
74,419
|
Operating lease
non-current liabilities
|
9,286
|
|
10,055
|
Other non-current
liabilities
|
2,867
|
|
4,390
|
Total
liabilities
|
100,553
|
|
88,864
|
Stockholders'
equity:
|
|
|
|
Common
stock
|
57
|
|
56
|
Additional paid-in
capital
|
677,955
|
|
669,223
|
Accumulated other
comprehensive loss
|
(1,431)
|
|
(175)
|
Accumulated
deficit
|
(168,032)
|
|
(164,176)
|
Total stockholders'
equity
|
508,549
|
|
504,928
|
Total liabilities and
stockholders' equity
|
$
609,102
|
|
$
593,792
|
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
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SOURCE Vanda Pharmaceuticals Inc.