WASHINGTON, Nov. 3, 2015 /PRNewswire/ -- Vanda
Pharmaceuticals Inc. (Vanda) (NASDAQ: VNDA), today announced
financial and operational results for the third quarter ended
September 30, 2015.
"With another strong performance in Q3, Vanda is on target to
achieve more than $100 million in net
product sales for 2015, which represents a significant milestone in
the history of the company," said Mihael H.
Polymeropoulos, M.D., Vanda's President and CEO. "We look
forward to growing our HETLIOZ Non-24 franchise, stabilizing Fanapt
revenue and pursuing exciting near-term opportunities, including
Jet Lag Disorder."
HETLIOZ® (tasimelteon)
- HETLIOZ® net product sales grew to $11.7 million in the third quarter of 2015, a 17%
increase compared to $10.0 million in
the second quarter of 2015 and a 124% increase compared to
$5.2 million reported in the third
quarter of 2014.
- A Phase III study of HETLIOZ® for the treatment of
Jet Lag Disorder is expected to begin in the first quarter of
2016.
- Preparations are ongoing for a 2016 European launch of
HETLIOZ® for the treatment of Non-24-Hour Sleep-Wake
Disorder (Non-24).
Fanapt® (iloperidone)
- Fanapt® net product sales of $16.7 million during the third quarter of 2015
reflected a 5% decline as compared to net product sales of
$17.6 million recorded in the second
quarter of 2015 and a 1% decline compared to $16.9 million reported by Novartis for
Fanapt® in the third quarter of 2014.
- Since August 2015, five
additional Fanapt® patents were listed in the U.S Food
and Drug Administration's (FDA) Orange Book further expanding the
method of use patent portfolio for Fanapt® which now
includes nine method patents with expiry dates that range from 2025
to 2031.
- In September 2015, the FDA
accepted for review a supplemental New Drug Application for
Fanapt® for the maintenance treatment of schizophrenia
in adults. The FDA has set a PDUFA goal date in May 2016 to complete its review.
- Vanda expects to file for European regulatory approval of oral
Fanapt® in the fourth quarter of 2015.
Cash, cash equivalents and marketable securities were
$144.3 million as of September 30, 2015.
Non-GAAP Financial Results
Vanda Non-GAAP total revenues for the third quarter of 2015 were
$28.3 million, compared to Non-GAAP
total revenues of $7.0 million for
the third quarter of 2014.
For the third quarter of 2015, Non-GAAP net loss was
$4.5 million, or $0.11 per share, compared with a Non-GAAP net
loss of $7.2 million, or $0.21 per share, for the same period in 2014.
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."
Vanda Affirms 2015 Financial Guidance
Vanda is affirming its 2015 financial guidance and expects to
achieve the following financial objectives in 2015:
- Combined net product sales from both HETLIOZ® and
Fanapt® of between $100 million
and $115 million.
- HETLIOZ® net product sales of between $40 million to $45 million.
- Fanapt® net product sales of between $60 million to $70 million.
- Non-GAAP Operating expenses, excluding cost of goods sold, of
between $100 million and $110
million.
Non-GAAP Operating expenses also excludes:
- Intangible asset amortization expense of $13.0 million.
- Stock-based compensation of between $8.5
million and $10.5 million.
Full U.S. HETLIOZ® Prescribing Information
can be found at: www.hetlioz.com.
Full U.S. Fanapt® Prescribing Information,
including Boxed Warnings and Important Safety Information can be
found at: www.fanapt.com.
Conference Call
Vanda has scheduled a conference call for today, Tuesday, November 3, 2015, at 4:30 PM ET. During the call, Vanda's
management will discuss the third quarter 2015 financial results
and other corporate activities. Investors can call
1-800-708-4539 (domestic) or 1-847-619-6396 (international) and use
passcode 40977296. A replay of the call will be available beginning
Tuesday, November 3, 2015 at
7:00 PM ET and will be accessible
until Tuesday, November 10, 2015, 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 40977296.
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 Total revenues" excludes Fanapt®
licensing revenue. 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)" and "Non-GAAP net income (loss) per share"
exclude Fanapt® licensing revenue, stock-based
compensation, intangible asset amortization and gain on arbitration
settlement.
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 2015 Non-GAAP
Operating expenses, excluding cost of goods sold, a forward-looking
Non-GAAP financial measure under the heading "2015 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 the
Non-GAAP financial measures to their most directly comparable GAAP
financial measure.
About Vanda Pharmaceuticals Inc.
Vanda Pharmaceuticals Inc. is a biopharmaceutical company
focused on the development and commercialization of products for
the treatment of central nervous system disorders. For more
on Vanda, please visit www.vandapharma.com.
Forward-Looking Statements
Various statements in this release, including, but not limited
to, the guidance provided in the heading of this press release and
under "Vanda Affirms 2015 Financial Guidance" above, and statements
regarding Vanda's clinical plans for HETLIOZ®, Vanda's
European commercial launch of HETLIOZ® and Vanda's U.S.
and EU regulatory strategy for Fanapt®, are
"forward-looking statements" under the securities laws. Words
such as, but not limited to, "believe," "expect," "anticipate,"
"estimate," "intend," "plan," "project," "target," "goal,"
"likely," "will," "would," and "could," or the negative of these
terms and similar expressions or words, identify forward-looking
statements. 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
ability to successfully commercialize HETLIOZ® for the
treatment of Non-24 in the U.S. and Europe; uncertainty as to the market awareness
of Non-24 and the market acceptance of HETLIOZ®; Vanda's
ability to generate U.S. sales of Fanapt® for the
treatment of schizophrenia; the timing and costs of Vanda's
establishment of a sales and marketing, supply chain, distribution,
pharmacovigilance, compliance and safety infrastructure to promote
Fanapt® in the U.S.; Vanda's dependence on third-party
manufacturers to manufacture HETLIOZ® and
Fanapt® in sufficient quantities and quality; Vanda's
limited sales and marketing infrastructure; the regulatory status
of Fanapt® in Europe;
Vanda's ability to successfully commercialize HETLIOZ®
and Fanapt® outside the U.S.; Vanda's ability to
prepare, file, prosecute, defend and enforce any patent claims and
other intellectual property rights; Vanda's ability to obtain the
capital necessary to fund its research and development or
commercial activities; a loss of rights to develop and
commercialize Vanda's products under its license agreements; the
ability to obtain and maintain regulatory approval of Vanda's
products, and the labeling for any approved products; the timing
and success of preclinical studies and clinical trials conducted by
Vanda or its development partners; a failure of Vanda's products to
be demonstrably safe and effective; the size and growth of the
potential markets for Vanda's products and the ability to serve
those markets; Vanda's expectations regarding trends with respect
to its revenues, costs, expenses and liabilities; the timing and
costs of complying with the remaining post-marketing commitments
and post-marketing requirements established in connection with the
FDA's approval of Fanapt®; the scope, progress,
expansion, and costs of developing and commercializing Vanda's
products; Vanda's failure to identify or obtain rights to new
products; a loss of any of Vanda's key scientists or management
personnel; limitations on Vanda's ability to utilize some or all of
its prior net operating losses and orphan drug and research and
development credits; the costs and effects of litigation; losses
incurred from product liability claims made against Vanda; use of
existing cash, cash equivalents and marketable securities 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, 2014
and quarterly report on Form 10-Q for the quarter ended
June 30, 2015 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, 2015, to be filed with the SEC in
the fourth quarter of 2015. In addition to the risks
described above and in Vanda's annual report on Form 10-K and
quarterly reports on Form 10-Q, current reports on Form 8-K and
other filings with the SEC, 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 (Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended
|
|
Nine Months
Ended
|
|
September
30
|
|
September
30
|
|
September
30
|
|
September
30
|
(in thousands,
except for share and per share amounts)
|
2015
|
|
2014
|
|
2015
|
|
2014
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues:
|
|
|
|
|
|
|
|
|
|
|
|
|
HETLIOZ®product sales, net
|
$
|
11,682
|
|
$
|
5,222
|
|
$
|
29,159
|
|
$
|
6,781
|
|
Fanapt®product sales, net
|
|
16,662
|
|
|
107
|
|
|
48,917
|
|
|
107
|
|
Fanapt®royalty revenue
|
|
-
|
|
|
1,689
|
|
|
-
|
|
|
4,919
|
|
Fanapt®licensing revenue
|
|
-
|
|
|
7,764
|
|
|
-
|
|
|
22,981
|
|
|
Total
revenues
|
|
28,344
|
|
|
14,782
|
|
|
78,076
|
|
|
34,788
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of goods
sold
|
|
6,510
|
|
|
703
|
|
|
17,291
|
|
|
901
|
|
Research and
development
|
|
9,974
|
|
|
3,701
|
|
|
20,398
|
|
|
14,479
|
|
Selling, general and
administrative
|
|
18,458
|
|
|
11,290
|
|
|
55,650
|
|
|
67,321
|
|
Intangible asset
amortization
|
|
2,943
|
|
|
536
|
|
|
10,029
|
|
|
1,718
|
|
|
Total operating
expenses
|
|
37,885
|
|
|
16,230
|
|
|
103,368
|
|
|
84,419
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) from
operations
|
|
(9,541)
|
|
|
(1,448)
|
|
|
(25,292)
|
|
|
(49,631)
|
|
Other
income
|
|
80
|
|
|
22
|
|
|
225
|
|
|
98
|
Net income
(loss)
|
$
|
(9,461)
|
|
$
|
(1,426)
|
|
$
|
(25,067)
|
|
$
|
(49,533)
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) per
share:
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and
diluted
|
$
|
(0.22)
|
|
$
|
(0.04)
|
|
$
|
(0.60)
|
|
$
|
(1.46)
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average
shares outstanding:
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and
diluted
|
|
42,435,405
|
|
|
33,886,845
|
|
|
42,059,839
|
|
|
33,814,154
|
|
|
|
|
|
|
|
|
|
|
|
|
VANDA
PHARMACEUTICALS INC.
|
CONDENSED
CONSOLIDATED BALANCE SHEETS (Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
($ in
thousands)
|
|
|
|
|
September 30,
2015
|
|
December 31,
2014
|
|
|
|
|
|
|
|
|
|
|
|
ASSETS
|
|
|
|
|
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
|
$
|
46,786
|
|
$
|
60,901
|
|
|
Marketable
securities
|
|
|
|
|
97,529
|
|
|
68,921
|
|
|
Accounts receivable,
net
|
|
|
|
15,789
|
|
|
3,654
|
|
|
Inventory
|
|
|
|
|
|
3,797
|
|
|
5,170
|
|
|
Prepaid expenses and
other current assets
|
|
|
9,976
|
|
|
3,084
|
|
|
|
Total current
assets
|
|
|
|
|
173,877
|
|
|
141,730
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Property and
equipment, net
|
|
|
|
4,159
|
|
|
2,437
|
|
Intangible assets,
net
|
|
|
|
|
41,695
|
|
|
26,724
|
|
Restricted cash and
other
|
|
|
|
|
813
|
|
|
813
|
|
|
|
Total
assets
|
|
|
|
$
|
220,544
|
|
$
|
171,704
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
|
|
|
|
Accounts payable and
accrued liabilities
|
|
$
|
45,889
|
|
$
|
7,786
|
|
|
|
Total current
liabilities
|
|
|
|
45,889
|
|
|
7,786
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Milestone obligation
under license agreement
|
|
25,000
|
|
|
-
|
|
|
Other non-current
liabilities
|
|
|
|
3,718
|
|
|
3,101
|
|
|
|
Total
liabilities
|
|
|
|
|
74,607
|
|
|
10,887
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders'
equity:
|
|
|
|
|
|
|
|
|
|
|
Common
stock
|
|
|
|
|
43
|
|
|
41
|
|
|
Additional paid-in
capital
|
|
|
|
|
458,908
|
|
|
448,744
|
|
|
Accumulated other
comprehensive income
|
|
|
37
|
|
|
16
|
|
|
Accumulated
deficit
|
|
|
|
|
(313,051)
|
|
|
(287,984)
|
|
|
|
Total stockholders'
equity
|
|
|
|
145,937
|
|
|
160,817
|
|
|
|
Total liabilities and
stockholders' equity
|
|
$
|
220,544
|
|
$
|
171,704
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
VANDA
PHARMACEUTICALS INC.
|
Reconciliation of
GAAP to Non-GAAP Financial Information (Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended
|
|
Nine Months
Ended
|
|
September
30
|
|
September
30
|
|
September
30
|
|
September
30
|
(in thousands,
except for share and per share amounts)
|
2015
|
|
2014
|
|
2015
|
|
2014
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income
(loss)
|
$
|
(9,461)
|
|
$
|
(1,426)
|
|
$
|
(25,067)
|
|
$
|
(49,533)
|
Adjustments:
|
|
|
|
|
|
|
|
|
|
|
|
|
Fanapt®licensing revenue
|
|
-
|
|
|
(7,764)
|
|
|
-
|
|
|
(22,981)
|
|
Stock-based
compensation
|
|
2,061
|
|
|
1,411
|
|
|
6,074
|
|
|
4,247
|
|
Intangible asset
amortization
|
|
2,943
|
|
|
536
|
|
|
10,029
|
|
|
1,718
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP Net
loss
|
$
|
(4,457)
|
|
$
|
(7,243)
|
|
$
|
(8,964)
|
|
$
|
(66,549)
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP Net loss per
share:
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and
diluted
|
$
|
(0.11)
|
|
$
|
(0.21)
|
|
$
|
(0.21)
|
|
$
|
(1.97)
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average
shares outstanding:
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and
diluted
|
|
42,435,405
|
|
|
33,886,845
|
|
|
42,059,839
|
|
|
33,814,154
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
revenues
|
$
|
28,344
|
|
$
|
14,782
|
|
$
|
78,076
|
|
$
|
34,788
|
Adjustment:
|
|
|
|
|
|
|
|
|
|
|
|
|
Fanapt®licensing revenue
|
|
-
|
|
|
(7,764)
|
|
|
-
|
|
|
(22,981)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP Total
revenues
|
$
|
28,344
|
|
$
|
7,018
|
|
$
|
78,076
|
|
$
|
11,807
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses
|
$
|
37,885
|
|
$
|
16,230
|
|
$
|
103,368
|
|
$
|
84,419
|
Adjustments:
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of goods
sold
|
|
(6,510)
|
|
|
(703)
|
|
|
(17,291)
|
|
|
(901)
|
|
Stock-based
compensation
|
|
(2,061)
|
|
|
(1,411)
|
|
|
(6,074)
|
|
|
(4,247)
|
|
Intangible asset
amortization
|
|
(2,943)
|
|
|
(536)
|
|
|
(10,029)
|
|
|
(1,718)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP Operating
expenses
|
$
|
26,371
|
|
$
|
13,580
|
|
$
|
69,974
|
|
$
|
77,553
|
excluding Cost of
goods sold
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development
|
$
|
9,974
|
|
$
|
3,701
|
|
$
|
20,398
|
|
$
|
14,479
|
Adjustment:
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based
compensation
|
|
(516)
|
|
|
(442)
|
|
|
(1,743)
|
|
|
(1,377)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP Research and
development
|
$
|
9,458
|
|
$
|
3,259
|
|
$
|
18,655
|
|
$
|
13,102
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling, general and
administrative
|
$
|
18,458
|
|
$
|
11,290
|
|
$
|
55,650
|
|
$
|
67,321
|
Adjustment:
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based
compensation
|
|
(1,545)
|
|
|
(969)
|
|
|
(4,331)
|
|
|
(2,870)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP Selling,
general and administrative
|
$
|
16,913
|
|
$
|
10,321
|
|
$
|
51,319
|
|
$
|
64,451
|
COMPANY CONTACT:
Jim Kelly
Senior Vice President & Chief Financial Officer
Vanda Pharmaceuticals Inc.
(202) 734-3428
jim.kelly@vandapharma.com
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/vanda-pharmaceuticals-reports-third-quarter-2015-financial-results-300171512.html
SOURCE Vanda Pharmaceuticals Inc.