WASHINGTON, May 2, 2017 /PRNewswire/ -- Vanda
Pharmaceuticals Inc. (Vanda) (NASDAQ: VNDA), today announced
financial and operational results for the first quarter ended
March 31, 2017.
"We are pleased with the progress made in the first quarter of
2017 with the continued growth of our HETLIOZ business and the
successful expansion of the Fanapt U.S. field sales team," said
Mihael H. Polymeropoulos, M.D.,
Vanda's President and CEO. "Our research and development pipeline
is advancing and the tradipitant program is nearing completion of
the enrollment stage of the pruritus randomized clinical
study. We look forward to sharing the pruritus study results
in the third quarter of 2017."
Key Highlights:
- Total net product sales from HETLIOZ® and
Fanapt® were $37.4 million
during the first quarter of 2017, a 2% decrease compared to
$38.2 million in the fourth quarter
of 2016 and a 12% increase compared to $33.3
million the first quarter of 2016.
HETLIOZ® (tasimelteon)
- HETLIOZ® net product sales grew to $20.2 million in the first quarter of 2017, a 5%
increase compared to $19.3 million in
the fourth quarter of 2016 and a 25% increase compared to
$16.2 million in the first quarter of
2016.
Fanapt® (iloperidone)
- Fanapt® net product sales were $17.2 million in the first quarter of 2017, a 9%
decrease compared to $18.9 million in
the fourth quarter of 2016 and a 1% increase compared to
$17.1 million in the first quarter of
2016.
- An expansion of the Fanapt® U.S. field sales team
was completed during the first quarter of 2017.
Research and Development
HETLIOZ®
- Enrollment of patients for a Jet Lag Disorder clinical study is
ongoing. Results are expected in the second half of
2017.
- Enrollment in the Smith-Magenis Syndrome clinical study is
ongoing with results expected in 2018.
- A pharmacokinetic study of the HETLIOZ® pediatric
formulation is enrolling with results expected in 2018.
Fanapt®
- The Marketing Authorization Application (MAA) for oral
Fanaptum® tablets is under evaluation by the European
Medicines Agency for the treatment of schizophrenia in adults. A
decision on the Fanaptum® MAA is expected during the
second half of 2017.
Tradipitant
- Enrollment in a tradipitant clinical study for the treatment of
chronic pruritus in patients with atopic dermatitis is almost
complete. Results are expected in the third quarter of 2017.
- A tradipitant clinical study for the treatment of gastroparesis
is ongoing. Results are expected in the fourth quarter of
2017.
Cystic Fibrosis Transmembrane Conductance Regulator (CFTR)
Portfolio
- On March 29, 2017, Vanda
announced that it had entered into a license agreement with the
University of California San Francisco
(UCSF) to develop and commercialize a portfolio of CFTR activators
and inhibitors.
- Vanda intends to complete the technology transfer activities
from UCSF and initiate investigational new drug enabling studies
for several CFTR indications during 2017.
Cash, cash equivalents and marketable securities (Cash) were
$137.8 million as of March 31, 2017, representing a decrease to Cash
of $3.6 million during the first
quarter of 2017.
Non-GAAP Financial Results
For the first quarter of 2017, Non-GAAP net loss was
$4.9 million, or $0.11 per share, compared to a Non-GAAP net loss
of $7.1 million, or $0.17 per share, for the first quarter of
2016.
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."
2017 Financial Guidance
Vanda reiterates its prior 2017 financial guidance and expects
to achieve the following financial objectives in 2017:
Financial
Objectives
|
2017
Guidance
|
Combined net product
sales from
both
HETLIOZ® and Fanapt®
|
$165 to $175
million
|
HETLIOZ®
net product sales
|
$88 to $93
million
|
Fanapt®
net product sales
|
$77 to $82
million
|
Non-GAAP Operating
expenses,
excluding Cost of
goods sold(1)
|
$162 to $172
million
|
Intangible asset
amortization
|
$1.7
million
|
Stock-based
compensation
|
$9 to $12
million
|
Year-end 2017
Cash
|
$121 to $141
million
|
(1) Non-GAAP Operating expenses, excludes cost of goods sold,
intangible asset amortization and stock-based compensation.
Conference Call
Vanda has scheduled a conference call for today, Tuesday, May 2, 2017, at 4:30 PM ET. During the call, Vanda's
management will discuss the first quarter 2017 financial results
and other corporate activities. Investors can call 1-800-708-4539
(domestic) or 1-847-619-6396 (international) and use passcode
44748467. A replay of the call will be available on Tuesday, May 2, 2017, beginning at 7:00 PM ET and will be accessible until
Tuesday, May 9, 2017, at 11:59 PM ET. The replay call-in number is
1-888-843-7419 for domestic callers and 1-630-652-3042 for
international callers. The passcode number is 44748467.
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 (loss)," "Non-GAAP Net
income (loss) 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.
This press release includes a projection of 2017 Non-GAAP
Operating expenses, excluding Cost of goods sold, a forward-looking
Non-GAAP financial measure under the heading "2017 Financial
Guidance." This Non-GAAP financial measure is determined by
excluding cost of goods sold, stock-based compensation and
intangible asset amortization. Vanda is unable to reconcile this
Non-GAAP guidance to GAAP because it is difficult to predict the
future impact of these adjustments.
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 in the subheading to this release and
under "2017 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 successfully
commercialize HETLIOZ® in Europe and obtain European Marketing
Authorization for oral Fanaptum® 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, 2016, which is 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 fiscal quarter
ended March 31, 2017, to be filed
with the SEC in the second quarter of 2017. 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.
COMPANY CONTACT:
Jim Kelly
Executive Vice President & Chief Financial Officer
Vanda Pharmaceuticals Inc.
(202) 734-3428
jim.kelly@vandapharma.com
VANDA
PHARMACEUTICALS INC.
|
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
|
(in thousands,
except for share and per share amounts)
|
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended
|
|
|
|
|
|
|
|
March
31
|
|
March
31
|
|
|
|
|
|
|
|
2017
|
|
2016
|
|
Revenues:
|
|
|
|
|
|
|
|
|
|
|
HETLIOZ®product sales, net
|
|
|
$
|
20,182
|
|
$
|
16,201
|
|
|
Fanapt®product sales, net
|
|
|
|
17,233
|
|
|
17,061
|
|
|
|
Total
revenues
|
|
|
|
|
37,415
|
|
|
33,262
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
Cost of goods sold
excluding amortization
|
|
|
4,003
|
|
|
5,956
|
|
|
Research and
development
|
|
|
|
10,567
|
|
|
7,548
|
|
|
Selling, general and
administrative
|
|
|
|
30,297
|
|
|
29,290
|
|
|
Intangible asset
amortization
|
|
|
|
454
|
|
|
2,943
|
|
|
|
Total operating
expenses
|
|
|
|
45,321
|
|
|
45,737
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from
operations
|
|
|
|
|
(7,906)
|
|
|
(12,475)
|
|
|
Other
income
|
|
|
|
|
280
|
|
|
117
|
|
Loss before income
taxes
|
|
|
|
|
(7,626)
|
|
|
(12,358)
|
|
|
Provision for income
taxes
|
|
|
|
19
|
|
|
-
|
|
Net loss
|
|
|
|
$
|
(7,645)
|
|
$
|
(12,358)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share,
basic and diluted
|
|
|
$
|
(0.17)
|
|
$
|
(0.29)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average
shares outstanding,basic and diluted
|
44,398,359
|
|
|
43,104,462
|
|
|
|
|
|
|
|
|
|
|
|
|
|
VANDA
PHARMACEUTICALS INC.
|
CONDENSED
CONSOLIDATED BALANCE SHEETS
|
(in
thousands)
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31
2017
|
|
December 31
2016
|
|
ASSETS
|
|
|
|
|
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
|
$
|
20,111
|
|
$
|
40,426
|
|
|
Marketable
securities
|
|
|
|
|
117,645
|
|
|
100,914
|
|
|
Accounts receivable,
net
|
|
|
|
17,751
|
|
|
20,268
|
|
|
Inventory
|
|
|
|
|
|
816
|
|
|
779
|
|
|
Prepaid expenses and
other current assets
|
|
|
12,239
|
|
|
11,788
|
|
|
|
Total current
assets
|
|
|
|
|
168,562
|
|
|
174,175
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Property and
equipment, net
|
|
|
|
5,461
|
|
|
5,015
|
|
Intangible assets,
net
|
|
|
|
|
27,365
|
|
|
27,819
|
|
Non-current inventory
and other
|
|
|
|
3,332
|
|
|
3,365
|
|
|
|
Total
assets
|
|
|
|
$
|
204,720
|
|
$
|
210,374
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
|
|
|
|
Accounts payable and
accrued liabilities
|
|
$
|
18,025
|
|
$
|
16,196
|
|
|
Accrued government
and other rebates
|
|
|
29,943
|
|
|
34,124
|
|
|
Milestone obligation
under license agreement
|
|
|
|
|
25,000
|
|
|
-
|
|
|
|
Total current
liabilities
|
|
|
|
72,968
|
|
|
50,320
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Milestone obligation
under license agreement
|
|
|
|
-
|
|
|
25,000
|
|
|
Other non-current
liabilities
|
|
|
|
3,610
|
|
|
3,724
|
|
|
|
Total
liabilities
|
|
|
|
|
76,578
|
|
|
79,044
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders'
equity:
|
|
|
|
|
|
|
|
|
|
|
Common
stock
|
|
|
|
|
45
|
|
|
44
|
|
|
Additional paid-in
capital
|
|
|
|
|
481,551
|
|
|
477,087
|
|
|
Accumulated other
comprehensive income
|
|
|
50
|
|
|
58
|
|
|
Accumulated
deficit
|
|
|
|
|
(353,504)
|
|
|
(345,859)
|
|
|
|
Total stockholders'
equity
|
|
|
|
128,142
|
|
|
131,330
|
|
|
|
Total liabilities and
stockholders' equity
|
|
$
|
204,720
|
|
$
|
210,374
|
|
|
|
|
|
|
|
|
|
|
|
|
|
VANDA
PHARMACEUTICALS INC.
|
Reconciliation of
GAAP to Non-GAAP Financial Information
|
(in thousands,
except for share and per share amounts)
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended
|
|
|
|
|
|
|
|
March
31
|
|
March
31
|
|
|
|
|
|
|
|
2017
|
|
2016
|
|
Net loss
|
|
|
|
|
|
$
|
(7,645)
|
|
$
|
(12,358)
|
|
Adjustments:
|
|
|
|
|
|
|
|
|
|
|
Stock-based
compensation
|
|
|
|
2,256
|
|
|
2,266
|
|
|
Intangible asset
amortization
|
|
|
|
454
|
|
|
2,943
|
|
Non-GAAP Net
loss
|
|
|
|
$
|
(4,935)
|
|
$
|
(7,149)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP Net loss per
share, basic
|
|
|
$
|
(0.11)
|
|
$
|
(0.17)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average
shares outstanding, basic
|
|
|
44,398,359
|
|
|
43,104,462
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses
|
|
|
|
$
|
45,321
|
|
$
|
45,737
|
|
Adjustments:
|
|
|
|
|
|
|
|
|
|
|
Cost of goods sold
excluding amortization
|
|
|
(4,003)
|
|
|
(5,956)
|
|
|
Stock-based
compensation
|
|
|
|
(2,256)
|
|
|
(2,266)
|
|
|
Intangible asset
amortization
|
|
|
|
(454)
|
|
|
(2,943)
|
|
Non-GAAP Operating
expenses excluding
|
|
|
|
|
|
|
|
|
|
Cost of goods
sold
|
|
|
|
$
|
38,608
|
|
$
|
34,572
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
|
|
$
|
10,567
|
|
$
|
7,548
|
|
Adjustment:
|
|
|
|
|
|
|
|
|
|
|
Stock-based
compensation
|
|
|
|
(409)
|
|
|
(524)
|
|
Non-GAAP Research and
development
|
|
|
$
|
10,158
|
|
$
|
7,024
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling, general and
administrative
|
|
|
$
|
30,297
|
|
$
|
29,290
|
|
Adjustment:
|
|
|
|
|
|
|
|
|
|
|
Stock-based
compensation
|
|
|
|
(1,847)
|
|
|
(1,742)
|
|
Non-GAAP Selling,
general and administrative
|
|
$
|
28,450
|
|
$
|
27,548
|
|
|
|
|
|
|
|
|
|
|
|
|
|
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/vanda-pharmaceuticals-reports-first-quarter-2017-financial-results-300449874.html
SOURCE Vanda Pharmaceuticals Inc.