WASHINGTON, Nov. 6, 2019
/PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq:
VNDA) today announced financial and operational results for the
third quarter ended September 30,
2019.
"These results affirm Vanda's corporate strategy, and continue
to demonstrate our ability to grow our commercial assets and expand
our pipeline of products," said Mihael H.
Polymeropoulos, M.D., Vanda's President and CEO. "I am proud
of the progress we have made in our research and development
programs, with several new filings expected to be submitted within
the next two years. Furthermore, Vanda has put in place a proactive
regulatory strategy to better support our patients and
products."
Key Financial Highlights:
- Total net product sales from HETLIOZ® and
Fanapt® were $59.5 million
in the third quarter of 2019, a 21% increase compared to
$49.1 million in the third quarter of
2018.
- HETLIOZ® net product sales were $37.6 million in the third quarter of 2019, a 26%
increase compared to $29.9 million in
the third quarter of 2018.
- Fanapt® net product sales were $21.9 million in the third quarter of 2019, a 14%
increase compared to $19.2 million in
the third quarter of 2018.
- Cash, cash equivalents and marketable securities (Cash) were
$299.6 million as of September 30, 2019, representing an increase to
Cash of $59.0 million compared to
September 30, 2018.
Key Research and Development Highlights:
Tradipitant
- Enrollment in EPIONE, the Phase III clinical study of
tradipitant in atopic dermatitis, is complete. Results from EPIONE
are expected in the first quarter of 2020.
- In October 2019, EPIONE II, a
second Phase III clinical study of tradipitant in atopic
dermatitis, began enrolling patients.
- Enrollment in the Phase III study of tradipitant in
gastroparesis is ongoing as Vanda continues to engage with the U.S.
Food and Drug Administration (FDA) on tradipitant's regulatory
path.
- Vanda plans to initiate the Phase III program of tradipitant in
motion sickness in the fourth quarter of 2019. Vanda expects to
file a New Drug Application with the FDA for tradipitant for the
treatment of motion sickness in 2020.
HETLIOZ® (tasimelteon)
- Vanda received a complete response letter (CRL) on August 16, 2019 from the FDA related to the
supplemental New Drug Application (sNDA) of HETLIOZ® for
the treatment of Jet Lag Disorder (JLD). Vanda met with the FDA to
discuss the CRL in a Post Action meeting and is determining its
next steps.
- Vanda plans to meet with the FDA in the fourth quarter of 2019
to discuss the HETLIOZ® Smith-Magenis Syndrome clinical
study results and expects to submit an sNDA by year-end 2019.
- An observational study of delayed sleep phase disorder (DSPD)
is ongoing. Vanda plans to initiate a Phase III clinical study of
HETLIOZ® in DSPD patients by year-end 2019.
Fanapt® (iloperidone)
- A pharmacokinetic study for the once-a-month long acting
injectable (LAI) formulation of Fanapt® is ongoing.
- A study of Fanapt® in bipolar disorder is planned to
begin by year-end 2019.
VTR-297 (histone deactetylase (HDAC) inhibitor)
- Enrollment in the Phase I clinical study (1101) of VTR-297 in
hematologic malignancies is ongoing.
Corporate Highlights:
- Vanda announced the appointment of Anne
Sempowski Ward to its Board of Directors, effective
October 28, 2019, increasing the
total number of members on the Board to six.
- Vanda announced the hiring of Scott L.
Howell as its Chief People Officer, Aranthan "AJ" Jones II
as its Chief Corporate Affairs and Communications Officer and
Joakim "Kim" Wijkstrom as its Chief Marketing Officer, further
bolstering the executive leadership team.
GAAP Financial Results
Net income was $100.4 million for
the third quarter of 2019, or $1.88
per share, compared to net income of $7.2
million, or $0.14 per share,
for the third quarter of 2018.
The income tax benefit of $88.1
million reflected in the financial results for the third
quarter of 2019 includes the favorable impact of the release of
Vanda's deferred tax asset valuation allowance.
Income before income taxes was $12.3
million in the third quarter of 2019, a 69% increase
compared to $7.3 million in the third
quarter of 2018.
2019 Financial Guidance
Vanda reiterates its 2019 net product sales guidance and expects
results in the upper half of the range. In addition, Vanda
provides an update to Year-end 2019 Cash and expects to achieve the
following financial objectives in 2019:
Full Year
2019
Financial
Objectives
|
Full Year
2019
Guidance
|
Combined net product
sales from both
HETLIOZ® and Fanapt®
|
$215 to $225
million1
|
HETLIOZ®
net product sales
|
$137 to $143
million1
|
Fanapt®
net product sales
|
$78 to $82
million1
|
Year-end 2019
Cash
|
Greater than $295
million
as compared to prior
guidance of
Greater than $275
million
|
1) Results
expected in the upper half of the range
|
|
Conference Call
Vanda has scheduled a conference call for today, Wednesday, November 6, 2019, at 4:30 PM ET. During the call, Vanda's management
will discuss the third quarter 2019 financial results and other
corporate activities. Investors can call 1-866-688-9426 (domestic)
or 1-409-216-0816 (international) and use passcode 5377942. A
replay of the call will be available on Wednesday, November 6, 2019, beginning at
7:30 PM ET and will be accessible
until Wednesday, November 13, 2019,
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 5377942.
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 "2019 Financial Guidance" above,
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 complete the clinical development and obtain regulatory
approval of tradipitant for the treatment of motion sickness,
gastroparesis and/or chronic pruritus in atopic dermatitis, the
outcome of the lawsuit initiated by Vanda against the FDA relating
to tradipitant, Vanda's discussion and potential resolution of the
deficiencies that the FDA believes are contained in the sNDA for
HETLIOZ® for the treatment of Jet Lag Disorder and
Vanda's ability to obtain marketing approval for the use of
HETLIOZ® in the treatment of Jet Lag Disorder following
any such resolution, Vanda's ability to complete the clinical
development, submit an sNDA and obtain regulatory approval of
tasimelteon for the treatment of sleep disorders in patients with
Smith-Magenis Syndrome 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, 2018 and quarterly report on Form
10-Q for the quarter ended June 30,
2019, which are 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 September 30,
2019, to be filed with the SEC in the fourth quarter of
2019. 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
|
|
Nine Months
Ended
|
|
|
|
|
|
|
September
30
|
|
September
30
|
|
September
30
|
|
September
30
|
|
|
|
|
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
Revenues:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
HETLIOZ®product sales, net
|
$
|
37,589
|
|
$
|
29,923
|
|
$
|
104,381
|
|
$
|
83,391
|
|
Fanapt®product sales, net
|
|
21,896
|
|
|
19,212
|
|
|
61,877
|
|
|
56,686
|
|
|
Total
revenues
|
|
59,485
|
|
|
49,135
|
|
|
166,258
|
|
|
140,077
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of goods sold
excluding amortization
|
|
6,782
|
|
|
5,068
|
|
|
18,263
|
|
|
14,841
|
|
Research and
development
|
|
11,347
|
|
|
11,390
|
|
|
35,575
|
|
|
30,672
|
|
Selling, general and
administrative
|
|
30,221
|
|
|
26,047
|
|
|
92,718
|
|
|
80,829
|
|
Intangible asset
amortization
|
|
376
|
|
|
397
|
|
|
1,135
|
|
|
1,147
|
|
|
Total operating
expenses
|
|
48,726
|
|
|
42,902
|
|
|
147,691
|
|
|
127,489
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income from
operations
|
|
10,759
|
|
|
6,233
|
|
|
18,567
|
|
|
12,588
|
|
Other
income
|
|
1,517
|
|
|
1,030
|
|
|
4,651
|
|
|
2,440
|
Income before income
taxes
|
|
12,276
|
|
|
7,263
|
|
|
23,218
|
|
|
15,028
|
|
Provision (benefit)
for income taxes
|
|
(88,147)
|
|
|
92
|
|
|
(88,119)
|
|
|
180
|
Net income
|
$
|
100,423
|
|
$
|
7,171
|
|
$
|
111,337
|
|
$
|
14,848
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income per share,
basic
|
$
|
1.88
|
|
$
|
0.14
|
|
$
|
2.10
|
|
$
|
0.30
|
Net income per share,
diluted
|
$
|
1.84
|
|
$
|
0.13
|
|
$
|
2.03
|
|
$
|
0.28
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average
shares outstanding, basic
|
|
53,297,298
|
|
|
52,389,012
|
|
|
53,052,521
|
|
|
50,321,640
|
Weighted average
shares outstanding, diluted
|
|
54,541,625
|
|
|
54,709,749
|
|
|
54,803,851
|
|
|
52,315,642
|
VANDA
PHARMACEUTICALS INC.
|
CONDENSED
CONSOLIDATED BALANCE SHEETS
|
(in
thousands)
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30
2019 (1)
|
|
December 31
2018 (1)
|
|
ASSETS
|
|
|
|
|
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
|
$
|
39,208
|
|
$
|
61,005
|
|
|
Marketable
securities
|
|
|
|
|
198,577
|
|
|
196,355
|
|
|
Accounts receivable,
net
|
|
|
|
26,824
|
|
|
28,780
|
|
|
Inventory
|
|
|
|
|
|
1,019
|
|
|
994
|
|
|
Prepaid expenses and
other current assets
|
|
|
14,382
|
|
|
11,998
|
|
|
|
Total current
assets
|
|
|
|
|
280,010
|
|
|
299,132
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Marketable
securities, non-current
|
|
|
61,827
|
|
|
-
|
|
Property and
equipment, net
|
|
|
|
4,156
|
|
|
4,417
|
|
Operating lease
right-of-use assets
|
|
|
11,436
|
|
|
-
|
|
Intangible assets,
net
|
|
|
|
|
23,407
|
|
|
24,542
|
|
Deferred tax
assets
|
|
|
|
|
89,072
|
|
|
-
|
|
Non-current inventory
and other
|
|
|
|
4,541
|
|
|
4,039
|
|
|
|
Total
assets
|
|
|
|
$
|
474,449
|
|
$
|
332,130
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
|
|
|
|
Accounts payable and
accrued liabilities
|
|
$
|
26,992
|
|
$
|
21,584
|
|
|
Product revenue
allowances
|
|
|
|
33,004
|
|
|
31,231
|
|
|
Milestone obligations
under license agreements
|
|
|
|
|
-
|
|
|
200
|
|
|
|
Total current
liabilities
|
|
|
|
59,996
|
|
|
53,015
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating lease
non-current liabilities
|
|
|
|
12,793
|
|
|
-
|
|
|
Other non-current
liabilities
|
|
|
|
753
|
|
|
3,693
|
|
|
|
Total
liabilities
|
|
|
|
|
73,542
|
|
|
56,708
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders'
equity:
|
|
|
|
|
|
|
|
|
|
|
Common
stock
|
|
|
|
|
53
|
|
|
52
|
|
|
Additional paid-in
capital
|
|
|
|
|
625,524
|
|
|
611,587
|
|
|
Accumulated other
comprehensive income
|
|
|
211
|
|
|
1
|
|
|
Accumulated
deficit
|
|
|
|
|
(224,881)
|
|
|
(336,218)
|
|
|
|
Total stockholders'
equity
|
|
|
|
400,907
|
|
|
275,422
|
|
|
|
Total liabilities and
stockholders' equity
|
|
$
|
474,449
|
|
$
|
332,130
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1)
|
With the adoption of
Accounting Standards Codification Subtopic ASC 842, Leases, on
January 1, 2019, Vanda recognized operating lease liabilities and
right-of-use assets. Prior period financial statements were not
recast for the new leasing standard. Please refer to footnote 2 in
the quarterly report on Form 10-Q for the quarter ended September
30, 2019, to be filed in the fourth quarter of 2019, for more
information.
|
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.