WASHINGTON, May 8, 2014 /PRNewswire/ -- Vanda Pharmaceuticals
Inc. (Vanda) (NASDAQ: VNDA), a biopharmaceutical company focused on
the development and commercialization of products for the treatment
of central nervous system disorders, today announced financial and
operational results for the first quarter ended March 31, 2014.
Key Highlights:
- On January 31, 2014, Vanda
announced that the U.S. Food and Drug Administration (FDA) approved
HETLIOZ™ (tasimelteon) 20mg capsules for the treatment of
Non-24-Hour Sleep-Wake Disorder (Non-24). Non-24 affects the
majority of totally blind individuals and it is estimated that
approximately 80,000 Americans have the disorder.
- On April 21, 2014, Vanda
launched HETLIOZ™ in the U.S. HETLIOZSolutions™ was also launched
to support and facilitate the treatment of blind individuals in the
U.S. living with Non-24.
FIRST QUARTER 2014 REPORTED RESULTS
Total revenues for the first quarter of 2014 were $9.1 million, compared to $8.1 million for the first quarter of 2013.
First quarter 2014 revenues included $1.7 million in Fanapt® royalties
received from Novartis as compared to royalties of $1.5 million for the first quarter of 2013.
Licensing revenues recognized from the amortization of the
$200.0 million upfront payment
received from Novartis for Fanapt® U.S. and Canadian
rights were $7.5 million for the
first quarter 2014, compared to $6.6
million for the first quarter of 2013. The higher
amortization amount in the first quarter of 2014 resulted from a
shortening of the expected patent life for Fanapt® in
the U.S.
Total operating expenses for the first quarter of 2014 were
$35.7 million, compared to
$12.6 million for the first quarter
of 2013. Selling, general and administrative expenses of
$27.9 million for the first quarter
of 2014 were $23.7 million higher
than for the same period in 2013 and reflect the increased
commercial activity in preparation for the launch of HETLIOZ™ in
the U.S.
First quarter 2014 financial results include $10.0 million for milestone payments associated
with the FDA approval of the HETLIOZ™ New Drug Application.
An $8.0 million milestone payment was
made to Bristol-Myers Squibb, which payment is treated as an
intangible asset and will be amortized over the expected patent
life of HETLIOZ™ in the U.S. A $2.0
million regulatory consulting milestone payment was expensed
to Research & development in the first quarter of 2014.
Vanda recorded a net loss of $26.5
million for the first quarter of 2014, compared to a net
loss of $4.5 million for the first
quarter of 2013. Diluted net loss per share for the first
quarter of 2014 was $0.79, compared
to a diluted net loss per share of $0.16 for the same period in 2013.
Cash, cash equivalents and marketable securities (Cash) were
$100.4 million as of March 31, 2014.
First Quarter 2014 Key Financial Figures(1)
(2)
|
Three Months
Ended
|
|
|
|
|
($ in thousands,
except per share amounts)
|
March
31
2014
|
|
December
31
2013
|
|
Change
($)
|
|
Change
(%)
|
|
|
|
|
|
|
|
|
Total
revenues
|
$
9,143
|
|
$
8,783
|
|
$
360
|
|
4%
|
Research &
development expenses
|
7,263
|
|
6,270
|
|
993
|
|
16%
|
Selling, general
& administrative expenses
|
27,893
|
|
9,927
|
|
17,966
|
|
181%
|
Non-cash stock-based
compensation 3
|
1,393
|
|
1,407
|
|
(14)
|
|
(1%)
|
Net loss
|
(26,533)
|
|
(7,747)
|
|
(18,786)
|
|
(242%)
|
|
|
|
|
|
|
|
|
Diluted net loss per
share
|
$
(0.79)
|
|
$
(0.23)
|
|
$
(0.56)
|
|
(243%)
|
Select Cash Flow Data(1)(2)
|
Three Months
Ended
|
|
March
31
|
|
March
31
|
($ in
thousands)
|
2014
|
|
2013
|
Net cash provided by
(used in)
|
|
|
|
Operating
activities
|
$
(23,904)
|
|
$
(9,125)
|
Investing
activities
|
389
|
|
30,477
|
Financing
activities
|
2,011
|
|
(193)
|
Select Balance Sheet Data(1)
|
March
31
|
|
December
31
|
|
March
31
|
($ in
thousands)
|
2014
|
|
2013
|
|
2013
|
|
|
|
|
|
|
Total cash and
marketable securities
|
$
100,402
|
|
$
130,350
|
|
$
110,932
|
(1) Unaudited.
(2) Prior year amounts have been restated to reflect a change in
accounting method for the attribution of stock-based compensation.
Refer to footnote 3 in the quarterly report on Form 10Q for
the quarter ending March 31,
2014.
(3) Non-cash stock-based compensation is allocated to both Research
& development and Selling, general & administrative
expenses.
OPERATIONAL HIGHLIGHTS
On January 31, 2014, Vanda
announced that the FDA approved HETLIOZ™ 20mg capsules for the
treatment of Non-24. HETLIOZ™ is the first medication
approved by the FDA for the treatment of Non-24. Non-24
affects the majority of totally blind individuals and it is
estimated that approximately 80,000 Americans have the
disorder.
On April 21, 2014, Vanda launched
HETLIOZ™ in the U.S. HETLIOZSolutions™ was launched to
support and facilitate the treatment of blind individuals in the
U.S. living with Non-24. HETLIOZSolutions™
provides patients with a host of resources including information
about Non-24 and HETLIOZ™, insurance support, overview of financial
assistance programs, and pharmacy access.
During the first quarter of 2014, the Non-24 Disease Awareness
campaign was expanded with radio and television advertisements
broadcast nationwide. Our awareness campaign has resulted in
over 7,000 responses by individuals who opted in to learn more
about Non-24 and its treatment. The majority of responders
are likely patients and friends and family of blind individuals.
We have begun identifying Patient Directed Physician (PDP)
targets and, over the last few weeks, our field force has called
upon approximately 500 PDPs, which we believe will benefit patients
as they seek appropriate treatment for their condition.
Vanda expects to file for European regulatory approval of
HETLIOZ™ during 2014. This begins the effort to expand the
availability of HETLIOZ™ to markets outside of the U.S.
HETLIOZ™ was previously granted orphan drug designation by the
European Commission for the treatment of Non-24.
Vanda recorded first quarter 2014 revenues of $9.1 million including Fanapt®
royalties of $1.7 million.
Fanapt® prescriptions, as reported by IMS, were
approximately 40,600 for the first quarter of 2014. This
represents a 6% decrease versus fourth quarter 2013 prescriptions
and a 5% increase over first quarter 2013 Fanapt®
prescriptions.
2014 FINANCIAL GUIDANCE
- Total 2014 operating expenses are expected to be between
$110.0 and $120.0 million. This
includes intangible asset amortization expense of $2.5 million and $6.0 to $8.0
million of non-cash stock based compensation. Total 2013
operating expenses were $54.3
million.
- Full year 2014 expenses are expected to reflect lower research
and development spending as compared to 2013 and an increase in
commercial spending to support the commercial launch of HETLIOZ™ in
the U.S.
Full HETLIOZ™ Prescribing Information can be found at:
www.hetlioz.com.
CONFERENCE CALL
Vanda has scheduled a conference call for today, Thursday, May 8, 2014, at 10:00 AM ET. During the call, Vanda's
management will discuss the first quarter 2014 financial results
and other corporate activities. Investors can call
1-888-895-5271 (domestic) and 1-847-619-6547 (international) and
use passcode 37132179. A replay of the call will be available
beginning Thursday, May 8, 2014 at
12:30 PM ET and will be accessible
until Thursday, May 15, 2014, 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 access number is 37132179.
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.
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.
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
Various statements in this release, including, but not limited
to, the guidance provided under "2014 FINANCIAL GUIDANCE" above,
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
the company's forward-looking statements include, among others:
Vanda's ability to successfully commercialize HETLIOZ™ for the
treatment of Non-24 in the U.S., uncertainty as to the market
awareness of Non-24 and the market acceptance of HETLIOZ™, Vanda's
dependence on third-party manufacturers to manufacture HETLIOZ™ in
sufficient quantities and quality, Vanda's limited sales and
marketing infrastructure, the regulatory status of tasimelteon in
Europe 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, 2013 and quarterly
report on Form 10-Q for the quarter ended March 31, 2014, which are on file with the SEC
and available on the SEC's website at www.sec.gov. 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
|
|
|
|
|
|
|
March 31
|
|
March 31
|
|
($ in thousands,
except per share amounts)
|
|
2014
|
|
2013
(1)
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues:
|
|
|
|
|
|
|
|
|
|
Licensing
agreement
|
|
$
|
7,452
|
|
$
|
6,606
|
|
|
Royalty
revenue
|
|
|
|
1,691
|
|
|
1,462
|
|
|
|
Total
revenues
|
|
|
|
9,143
|
|
|
8,068
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
|
7,263
|
|
|
8,111
|
|
|
Selling, general and
administrative
|
|
27,893
|
|
|
4,153
|
|
|
Intangible asset
amortization
|
|
|
565
|
|
|
369
|
|
|
|
Total operating
expenses
|
|
|
35,721
|
|
|
12,633
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from
operations
|
|
|
|
(26,578)
|
|
|
(4,565)
|
|
|
Other
income
|
|
|
|
45
|
|
|
46
|
|
Loss before tax
benefit
|
|
|
(26,533)
|
|
|
(4,519)
|
|
|
Tax
benefit
|
|
|
|
-
|
|
|
-
|
|
Net loss
|
|
|
$
|
(26,533)
|
|
$
|
(4,519)
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per
share:
|
|
|
|
|
|
|
|
|
|
Basic and
diluted
|
|
|
$
|
(0.79)
|
|
$
|
(0.16)
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares used in
calculations of net loss
|
|
|
|
|
|
|
|
per share:
|
|
|
|
|
|
|
|
|
|
Basic and
diluted
|
|
|
#
|
33,678,706
|
|
|
28,345,555
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) Prior year amounts have been restated to reflect a change in
accounting method for the attribution of stock-based compensation.
Refer to footnote 3 in the quarterly report on Form 10Q for the
quarter ending March 31, 2014.
VANDA
PHARMACEUTICALS INC.
|
|
CONDENSED
CONSOLIDATED BALANCE SHEETS (Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
($ in
thousands)
|
|
|
|
|
March 31,
2014
|
|
December 31,
2013 (1)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ASSETS
|
|
|
|
|
|
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
|
$
|
43,260
|
|
$
|
64,764
|
|
|
|
Marketable
securities
|
|
|
|
|
57,142
|
|
|
65,586
|
|
|
|
Accounts
receivable
|
|
|
|
|
1,691
|
|
|
2,031
|
|
|
|
Inventory
|
|
|
|
|
|
192
|
|
|
-
|
|
|
|
Prepaid expenses and
other current assets
|
|
|
3,132
|
|
|
2,703
|
|
|
|
Restricted
cash
|
|
|
|
|
100
|
|
|
530
|
|
|
|
|
Total current
assets
|
|
|
|
|
105,517
|
|
|
135,614
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Property and
equipment, net
|
|
|
|
2,208
|
|
|
2,198
|
|
|
Intangible asset,
net
|
|
|
|
|
12,472
|
|
|
5,037
|
|
|
Restricted cash,
non-current
|
|
|
|
785
|
|
|
500
|
|
|
|
|
Total
assets
|
|
|
|
$
|
120,982
|
|
$
|
143,349
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
Accounts
payable
|
|
|
|
$
|
953
|
|
$
|
661
|
|
|
|
Accrued
liabilities
|
|
|
|
|
13,164
|
|
|
5,180
|
|
|
|
Deferred
rent
|
|
|
|
|
228
|
|
|
221
|
|
|
|
Deferred
revenues
|
|
|
|
|
31,059
|
|
|
26,789
|
|
|
|
|
Total current
liabilities
|
|
|
|
45,404
|
|
|
32,851
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deferred rent,
non-current
|
|
|
|
2,831
|
|
|
2,888
|
|
|
|
Deferred revenues,
non-current
|
|
|
51,764
|
|
|
63,486
|
|
|
|
|
Total
liabilities
|
|
|
|
|
99,999
|
|
|
99,225
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders'
equity:
|
|
|
|
|
|
|
|
|
|
|
|
Common
stock
|
|
|
|
|
34
|
|
|
33
|
|
|
|
Additional paid-in
capital
|
|
|
|
355,644
|
|
|
352,240
|
|
|
|
Accumulated other
comprehensive income
|
|
|
8
|
|
|
21
|
|
|
|
Accumulated
deficit
|
|
|
|
|
(334,703)
|
|
|
(308,170)
|
|
|
|
|
Total stockholders'
equity
|
|
|
|
20,983
|
|
|
44,124
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities and
stockholders' equity
|
|
$
|
120,982
|
|
$
|
143,349
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) Prior year amounts have been restated to reflect a change in
accounting method for the attribution of stock-based compensation.
Refer to footnote 3 in the quarterly report on Form 10Q for the
quarter ending March 31,
2014.
INVESTOR CONTACT:
Chad Rubin
Vice President
The Trout Group
(646) 378-2947
crubin@troutgroup.com
SOURCE Vanda Pharmaceuticals Inc.