WASHINGTON, July 31, 2019 /PRNewswire/ -- Vanda
Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced
financial and operational results for the second quarter ended
June 30, 2019.
"The exceptional commercial performance of HETLIOZ and Fanapt
positions Vanda to continue on its path of growth and long term
value creation," said Mihael H.
Polymeropoulos, M.D., Vanda's President and CEO. "The
recently announced positive results from the tradipitant motion
sickness study further enhance the potentially broad therapeutic
utility of tradipitant as a treatment option for the millions of
patients with gastroparesis, motion sickness and atopic
dermatitis."
Key Financial Highlights:
- Total net product sales from HETLIOZ® and
Fanapt® were $59.1 million
in the second quarter of 2019, a 24% increase compared to
$47.7 million in the first quarter of
2019 and a 25% increase compared to $47.4
million in the second quarter of 2018.
- HETLIOZ® net product sales were $37.8 million in the second quarter of 2019, a
31% increase compared to $29.0
million in the first quarter of 2019 and a 35% increase
compared to $28.0 million in the
second quarter of 2018.
- Fanapt® net product sales were $21.2 million in the second quarter of 2019, a
13% increase compared to $18.8
million in the first quarter of 2019 and a 10% increase
compared to $19.3 million in the
second quarter of 2018.
- Cash, cash equivalents and marketable securities (Cash) were
$292.7 million as of June 30, 2019, representing an increase to Cash
of $24.8 million as compared to
March 31, 2019.
Key Research and Development Highlights:
Tradipitant
- In July 2019, Vanda announced
positive results from a Phase II clinical study (Motion Sifnos) of
tradipitant in motion sickness. Patients with a prior history
of motion sickness were treated with tradipitant or placebo prior
to a chartered trip on the Pacific Ocean. In this setting,
significantly fewer patients on tradipitant vomited than those on
placebo. Vanda intends to initiate a Phase III program in
motion sickness in 2019 with a plan to file for marketing
authorization in 2020.
- After meeting with the U.S. Food and Drug Administration (FDA)
in May 2019 to discuss the Phase III
program, Vanda initiated a Phase III clinical study of tradipitant
in gastroparesis in the second quarter of 2019 and plans to begin
randomizing patients in the third quarter of 2019.
- Enrollment in the Phase III clinical study (EPIONE) of
tradipitant in atopic dermatitis is ongoing. Results are expected
in the first half of 2020. A second Phase III clinical study
is expected to begin in the first quarter of
2020.
HETLIOZ® (tasimelteon)
- The FDA's review of the supplemental New Drug Application
(sNDA) of HETLIOZ® for the treatment of jet lag disorder is ongoing
with a Prescription Drug User Fee Act (PDUFA) target date of
August 16, 2019. On July 19, 2019, Vanda received a "Deficiencies
Preclude Discussion" letter from the FDA. The letter
does not specify any deficiencies in the file at this time.
Vanda will await the PDUFA action and work expeditiously to resolve
any potential deficiencies.
- Vanda expects to file a sNDA for HETLIOZ® for the
treatment of Smith-Magenis Syndrome in the third quarter of 2019.
- Vanda plans in the third quarter of 2019 to initiate a Phase II
clinical study of HETLIOZ® in delayed sleep phase
disorder (DSPD) in patients who have a mutation in the CRY1 gene,
which is believed to be causative in a subset of patients with
DSPD.
Fanapt® (iloperidone)
- Enrollment is ongoing in a pharmacokinetic study for the
once-a-month long acting injectable (LAI) formulation of
Fanapt®.
- A randomized study of Fanapt® in bipolar disorder is
planned to begin in 2019.
VTR-297 (histone deactetylase (HDAC) inhibitor)
- Enrollment is ongoing in a Phase I clinical study (1101) of
VTR-297 in hematologic malignancies.
Non-GAAP Financial Results
Non-GAAP net income was $15.0
million for the second quarter of 2019, or $0.28 per share, compared to a Non-GAAP net
income of $7.7 million, or
$0.15 per share, for the second
quarter of 2018.
Vanda provides Non-GAAP financial information, which it believes
can enhance an overall understanding of its financial performance
when considered together with GAAP figures. Refer to the sections
of this press release entitled "Non-GAAP Financial Information" and
"Reconciliation of GAAP to Non-GAAP Financial Information" for more
detailed information regarding Non-GAAP financial information.
2019 Financial Guidance
Vanda reiterates its prior 2019 net product sales guidance and
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
million
|
HETLIOZ®
net product sales
|
$137 to $143
million
|
Fanapt®
net product sales
|
$78 to $82
million
|
Year-end 2019
Cash
|
Greater than $275
million
as compared to prior
guidance of
Greater than $260
million
|
Conference Call
Vanda has scheduled a conference call for today, Wednesday, July 31, 2019, at 4:30 PM ET. During the call, Vanda's
management will discuss the second 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
2589983. A replay of the call will be available on Wednesday, July 31, 2019, beginning at
7:30 PM ET and will be accessible
until Wednesday, August 7, 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 2589983.
The conference call will be broadcast simultaneously on Vanda's
website, www.vandapharma.com. Investors should click on the
Investor Relations 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.
Non-GAAP Financial Information
Vanda believes that the Non-GAAP financial information provided
in this press release can assist investors in understanding and
assessing the ongoing economics of Vanda's business and reflect how
it manages the business internally and sets operational goals.
Vanda's "Non-GAAP Selling, general and administrative expenses" and
"Non-GAAP Research and development expenses" exclude stock-based
compensation. Vanda's "Non-GAAP Net income," "Non-GAAP Net income
per share" and "Non-GAAP Operating expenses excluding Cost of goods
sold" exclude stock-based compensation and intangible asset
amortization.
Vanda believes that excluding the impact of these items better
reflects the recurring economic characteristics of its business, as
well as Vanda's use of financial resources and its long-term
performance.
These Non-GAAP financial measures, as presented, may not be
comparable to similarly titled measures reported by other companies
since not all companies may calculate these measures in an
identical manner and, therefore, they are not necessarily an
accurate measure of comparison between companies.
The presentation of these Non-GAAP financial measures is not
intended to be considered in isolation or as a substitute for
guidance prepared in accordance with GAAP. The principal limitation
of these Non-GAAP financial measures is that they exclude
significant elements that are required by GAAP to be recorded in
Vanda's financial statements. In addition, they are subject to
inherent limitations as they reflect the exercise of judgments by
management in determining these Non-GAAP financial measures.
In order to compensate for these limitations, Vanda presents its
Non-GAAP financial guidance in connection with its GAAP guidance.
Investors are encouraged to review the reconciliation of our
Non-GAAP financial measures to their most directly comparable GAAP
financial measure.
About Vanda Pharmaceuticals Inc.
Vanda is a 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
SMS 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
March 31, 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 June 30, 2019, to be filed with
the SEC in the third 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
|
|
Six Months
Ended
|
|
|
|
|
|
|
June
30
|
|
June
30
|
|
June
30
|
|
June
30
|
|
|
|
|
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
Revenues:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
HETLIOZ® product sales,
net
|
|
|
$
|
37,835
|
|
$
|
28,045
|
|
$
|
66,792
|
|
$
|
53,468
|
|
Fanapt®
product sales, net
|
|
|
|
21,225
|
|
|
19,305
|
|
|
39,981
|
|
|
37,474
|
|
|
Total
revenues
|
|
|
|
|
59,060
|
|
|
47,350
|
|
|
106,773
|
|
|
90,942
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of goods sold
excluding amortization
|
|
|
6,368
|
|
|
5,213
|
|
|
11,481
|
|
|
9,773
|
|
Research and
development
|
|
|
|
10,950
|
|
|
9,866
|
|
|
24,228
|
|
|
19,282
|
|
Selling, general and
administrative
|
|
|
|
31,468
|
|
|
27,960
|
|
|
62,497
|
|
|
54,782
|
|
Intangible asset
amortization
|
|
|
|
379
|
|
|
398
|
|
|
759
|
|
|
750
|
|
|
Total operating
expenses
|
|
|
|
49,165
|
|
|
43,437
|
|
|
98,965
|
|
|
84,587
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income from
operations
|
|
|
|
|
9,895
|
|
|
3,913
|
|
|
7,808
|
|
|
6,355
|
|
Other
income
|
|
|
|
|
1,649
|
|
|
788
|
|
|
3,134
|
|
|
1,410
|
Income before income
taxes
|
|
|
|
11,544
|
|
|
4,701
|
|
|
10,942
|
|
|
7,765
|
|
Provision for income
taxes
|
|
|
|
18
|
|
|
90
|
|
|
28
|
|
|
88
|
Net income
|
|
|
|
$
|
11,526
|
|
$
|
4,611
|
|
$
|
10,914
|
|
$
|
7,677
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income per share,
basic
|
|
|
$
|
0.22
|
|
$
|
0.09
|
|
$
|
0.21
|
|
$
|
0.16
|
Net income per share,
diluted
|
|
|
$
|
0.21
|
|
$
|
0.09
|
|
$
|
0.20
|
|
$
|
0.15
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average
shares outstanding, basic
|
|
|
53,101,499
|
|
|
52,172,982
|
|
|
52,928,101
|
|
|
49,270,829
|
Weighted average
shares outstanding, diluted
|
|
|
54,579,982
|
|
|
53,945,640
|
|
|
54,932,932
|
|
|
51,101,464
|
VANDA
PHARMACEUTICALS INC.
|
CONDENSED
CONSOLIDATED BALANCE SHEETS
|
(in
thousands)
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30
2019 (1)
|
|
December 31
2018 (1)
|
|
ASSETS
|
|
|
|
|
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
|
$
|
46,543
|
|
$
|
61,005
|
|
|
Marketable
securities
|
|
|
|
|
233,618
|
|
|
196,355
|
|
|
Accounts receivable,
net
|
|
|
|
23,890
|
|
|
28,780
|
|
|
Inventory
|
|
|
|
|
|
1,057
|
|
|
994
|
|
|
Prepaid expenses and
other current assets
|
|
|
10,694
|
|
|
11,998
|
|
|
|
Total current
assets
|
|
|
|
|
315,802
|
|
|
299,132
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Marketable
securities, non-current
|
|
|
12,517
|
|
|
-
|
|
Property and
equipment, net
|
|
|
|
4,240
|
|
|
4,417
|
|
Operating lease
right-of-use assets
|
|
|
11,718
|
|
|
-
|
|
Intangible assets,
net
|
|
|
|
|
23,783
|
|
|
24,542
|
|
Non-current inventory
and other
|
|
|
|
4,423
|
|
|
4,039
|
|
|
|
Total
assets
|
|
|
|
$
|
372,483
|
|
$
|
332,130
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
|
|
|
|
Accounts payable and
accrued liabilities
|
|
$
|
29,307
|
|
$
|
21,584
|
|
|
Product revenue
allowances
|
|
|
|
33,269
|
|
|
31,231
|
|
|
Milestone obligations
under license agreements
|
|
|
|
|
-
|
|
|
200
|
|
|
|
Total current
liabilities
|
|
|
|
62,576
|
|
|
53,015
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating lease
non-current liabilities
|
|
|
|
12,992
|
|
|
-
|
|
|
Other non-current
liabilities
|
|
|
|
221
|
|
|
3,693
|
|
|
|
Total
liabilities
|
|
|
|
|
75,789
|
|
|
56,708
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders'
equity:
|
|
|
|
|
|
|
|
|
|
|
Common
stock
|
|
|
|
|
53
|
|
|
52
|
|
|
Additional paid-in
capital
|
|
|
|
|
621,559
|
|
|
611,587
|
|
|
Accumulated other
comprehensive income
|
|
|
386
|
|
|
1
|
|
|
Accumulated
deficit
|
|
|
|
|
(325,304)
|
|
|
(336,218)
|
|
|
|
Total stockholders'
equity
|
|
|
|
296,694
|
|
|
275,422
|
|
|
|
Total liabilities and
stockholders' equity
|
|
$
|
372,483
|
|
$
|
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 June 30,
2019, to be filed in the third quarter of 2019, for more
information.
|
VANDA
PHARMACEUTICALS INC.
|
Reconciliation of
GAAP to Non-GAAP Financial Information
|
(in thousands,
except for share and per share amounts)
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended
|
|
Six Months
Ended
|
|
|
|
|
|
|
June
30
|
|
June
30
|
|
June
30
|
|
June
30
|
|
|
|
|
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
Net income
|
|
|
|
|
|
$
|
11,526
|
|
$
|
4,611
|
|
$
|
10,914
|
|
$
|
7,677
|
Adjustments:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based
compensation
|
|
|
|
3,101
|
|
|
2,721
|
|
|
6,383
|
|
|
5,872
|
Intangible asset
amortization
|
|
|
|
379
|
|
|
398
|
|
|
759
|
|
|
750
|
Non-GAAP Net
income
|
|
|
|
$
|
15,006
|
|
$
|
7,730
|
|
$
|
18,056
|
|
$
|
14,299
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP Net income
per share, basic
|
|
|
$
|
0.28
|
|
$
|
0.15
|
|
$
|
0.34
|
|
$
|
0.29
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average
shares outstanding, basic
|
|
|
53,101,499
|
|
|
52,172,982
|
|
|
52,928,101
|
|
|
49,270,829
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses
|
|
|
|
$
|
49,165
|
|
$
|
43,437
|
|
$
|
98,965
|
|
$
|
84,587
|
Adjustments:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of goods sold
excluding amortization
|
|
|
(6,368)
|
|
|
(5,213)
|
|
|
(11,481)
|
|
|
(9,773)
|
Stock-based
compensation
|
|
|
|
(3,101)
|
|
|
(2,721)
|
|
|
(6,383)
|
|
|
(5,872)
|
Intangible asset
amortization
|
|
|
|
(379)
|
|
|
(398)
|
|
|
(759)
|
|
|
(750)
|
Non-GAAP Operating
expenses excluding
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of goods
sold
|
|
|
|
$
|
39,317
|
|
$
|
35,105
|
|
$
|
80,342
|
|
$
|
68,192
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
|
|
$
|
10,950
|
|
$
|
9,866
|
|
$
|
24,228
|
|
$
|
19,282
|
Adjustment:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based
compensation
|
|
|
|
(756)
|
|
|
(316)
|
|
|
(1,484)
|
|
|
(637)
|
Non-GAAP Research and
development
|
|
|
$
|
10,194
|
|
$
|
9,550
|
|
$
|
22,744
|
|
$
|
18,645
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling, general and
administrative
|
|
|
$
|
31,468
|
|
$
|
27,960
|
|
$
|
62,497
|
|
$
|
54,782
|
Adjustment:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based
compensation
|
|
|
|
(2,345)
|
|
|
(2,405)
|
|
|
(4,899)
|
|
|
(5,235)
|
Non-GAAP Selling,
general and administrative
|
|
$
|
29,123
|
|
$
|
25,555
|
|
$
|
57,598
|
|
$
|
49,547
|
COMPANY CONTACT:
Jim Kelly
Executive Vice President & Chief Financial Officer
Vanda Pharmaceuticals Inc.
(202) 734-3428
jim.kelly@vandapharma.com
View original
content:http://www.prnewswire.com/news-releases/vanda-pharmaceuticals-reports-second-quarter-2019-financial-results-300894361.html
SOURCE Vanda Pharmaceuticals Inc.