WASHINGTON, Aug. 7, 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 second
quarter ended June 30, 2014.
"We are encouraged by the early positive reception of HETLIOZ by
patients, physicians and payors. We look forward to more patients
benefiting from HETLIOZ in the coming months and years," said
Mihael Polymeropoulos MD, President
and CEO of Vanda Pharmaceuticals.
Key Highlights:
- As of August 6, 2014, over 420
new patient prescriptions have been written for
HETLIOZ®(tasimelteon) in the U.S.
- In June 2014, Vanda announced
that the European Medicines Agency (EMA) accepted for evaluation
the Marketing Authorization Application for oral
HETLIOZ® capsules for the treatment of
Non-24-Hour Sleep-Wake Disorder (Non-24).
- In July 2014, the U.S. Patent
and Trademark Office (USPTO) issued a new method of use patent for
HETLIOZ® in the treatment of
Non-24.
SECOND QUARTER 2014 REPORTED RESULTS
Total revenues for the second quarter of 2014 were $10.9 million, compared to $9.1 million for the first quarter of 2014 and
$8.3 million for the second quarter
of 2013. Net product revenues related to U.S. sales of
HETLIOZ® in the second quarter of 2014 were $1.6 million.
Total operating expenses for the second quarter of 2014 were
$32.5 million, compared to
$35.7 million for the first quarter
of 2014 and $11.7 million for the
second quarter of 2013. Vanda recorded a net loss of
$21.6 million for the second quarter
of 2014, compared to a net loss of $26.5
million for the first quarter of 2014 and $3.4 million for the second quarter of
2013.
Cash, cash equivalents and marketable securities (Cash) were
$63.6 million as of June 30, 2014.
Year to Date June 30, 2014 Key
Financial Figures(1) (2)
|
Six Months
Ended
|
|
|
|
|
|
June
30,
|
|
June
30,
|
|
|
|
|
($ in thousands,
except per share amounts)
|
2014
|
|
2013
|
|
Change
($)
|
|
Change
(%)
|
|
|
|
|
|
|
|
|
Total
revenues
|
$
20,005
|
|
$
16,387
|
|
$
3,618
|
|
22%
|
Research &
development expenses
|
10,777
|
|
14,211
|
|
(3,434)
|
|
(24%)
|
Selling, general
& administrative expenses
|
56,032
|
|
9,413
|
|
46,619
|
|
495%
|
Non-cash stock-based
compensation (3)
|
2,836
|
|
2,432
|
|
404
|
|
17%
|
Net loss
|
(48,108)
|
|
(7,902)
|
|
(40,206)
|
|
(509%)
|
|
|
|
|
|
|
|
|
Diluted net loss per
share
|
$
(1.42)
|
|
$
(0.28)
|
|
$
(1.14)
|
|
(407%)
|
Second Quarter 2014 Key Financial Figures(1)
(2)
|
Three Months
Ended
|
|
|
|
|
|
June
30,
|
|
March
31,
|
|
|
|
|
($ in thousands,
except per share amounts)
|
2014
|
|
2014
|
|
Change
($)
|
|
Change
(%)
|
|
|
|
|
|
|
|
|
Total
revenues
|
$
10,862
|
|
$
9,143
|
|
$
1,719
|
|
19%
|
Research &
development expenses
|
3,514
|
|
7,263
|
|
(3,749)
|
|
(52%)
|
Selling, general
& administrative expenses
|
28,139
|
|
27,893
|
|
246
|
|
1%
|
Non-cash stock-based
compensation (3)
|
1,443
|
|
1,393
|
|
50
|
|
4%
|
Net loss
|
(21,575)
|
|
(26,533)
|
|
4,958
|
|
19%
|
|
|
|
|
|
|
|
|
Diluted net loss per
share
|
$
(0.64)
|
|
$
(0.79)
|
|
$
0.15
|
|
19%
|
Select Cash Flow Data(1)(2)
|
Six Months
Ended
|
|
June
30,
|
|
June
30,
|
($ in
thousands)
|
2014
|
|
2013
|
Net cash provided by
(used in)
|
|
|
|
Operating
activities
|
$
(60,569)
|
|
$
(17,168)
|
Investing
activities
|
10,756
|
|
31,428
|
Financing
activities
|
2,043
|
|
601
|
Select Balance Sheet Data(1)
|
June
30,
|
|
December
31
|
|
June
30,
|
($ in
thousands)
|
2014
|
|
2013
|
|
2013
|
|
|
|
|
|
|
Total
Cash(4)
|
$
63,585
|
|
$ 130,350
|
|
$ 103,633
|
(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 June
30, 2014.
|
(3) Non-cash
stock-based compensation is allocated to both Research &
development and Selling, general & administrative
expenses.
|
(4) Total Cash
reflects cash, cash equivalents and marketable
securities
|
OPERATIONAL HIGHLIGHTS
As of August 6, 2014, over 420 new
patient prescriptions have been written for HETLIOZ® in
the U.S. This represents growth of approximately 90% in new
prescriptions since the Company's June 4,
2014 commercial update. HETLIOZ® was
launched in the U.S. in April 2014
for the treatment of Non-24, a disorder which affects the majority
of totally blind individuals. It is estimated that approximately
80,000 Americans have the disorder.
On July 22, 2014, a new method of
use patent was issued by the USPTO for HETLIOZ® in the
treatment of Non-24 (patent number 8,785,492). The '492
patent is expected to expire in 2033, potentially further extending
the exclusivity protection of HETLIOZ®. In the U.S.,
HETLIOZ® is also covered by a composition of matter
patent (patent number 5,856,529), which including a Hatch-Waxman
5-year extension is currently expected to expire in 2022.
Both patents, '529 and '492, are now listed in the FDA's Orange
Book.
In June 2014, the EMA accepted for
evaluation Vanda's Marketing Authorization Application for oral
HETLIOZ® capsules for the treatment of Non-24.
HETLIOZ® was previously granted orphan drug
designation by the European Commission for the treatment of
Non-24.
Vanda has initiated development activities for the use of
HETLIOZ® in the pediatric population with Non-24, as
well as in patients with Smith-Magenis syndrome.
The VLY-686, NK1 antagonist, Phase 2 study in chronic pruritus
is ongoing and results are expected in mid-2015.
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 $2.3 million and $6.0 to $8.0
million of non-cash stock based compensation.
Full HETLIOZ® Prescribing Information can
be found at: www.hetlioz.com.
CONFERENCE CALL
Vanda has scheduled a conference call for today, Thursday, August 7, 2014, at 10:00 AM ET. During the call, Vanda's
management will discuss the second quarter 2014 financial results
and other corporate activities. Investors can call
1-800-708-4540 (domestic) and 1-847-619-6397 (international) and
use passcode 37729521. A replay of the call will be available
beginning Thursday, August 7, 2014 at
12:30 PM ET and will be accessible
until Thursday, August 14, 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 37729521.
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 HETLIOZ® 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 which is on file
with the SEC and available on the SEC's website at www.sec.gov and
Vanda's quarterly report on Form 10-Q for the quarter ended
June 30, 2014 to be filed with the
SEC. 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
|
|
Six Months
Ended
|
|
|
|
|
|
June 30,
|
|
June 30,
|
|
June 30,
|
|
June 30,
|
($ in thousands,
except per share amounts)
|
2014
|
|
2013
(1)
|
|
2014
|
|
2013
(1)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
HETLIOZ®product
revenue(2)
|
|
$
|
1,559
|
|
$
|
-
|
|
$
|
1,559
|
|
$
|
-
|
|
Fanapt®royalty revenue
|
|
|
1,539
|
|
|
1,641
|
|
|
3,230
|
|
|
3,103
|
|
Fanapt®licensing agreement
(3)
|
|
|
7,764
|
|
|
6,678
|
|
|
15,216
|
|
|
13,284
|
|
|
Total
revenues
|
|
|
|
10,862
|
|
|
8,319
|
|
|
20,005
|
|
|
16,387
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of
sales
|
|
|
|
198
|
|
|
-
|
|
|
198
|
|
|
-
|
|
Research and
development
|
|
|
3,514
|
|
|
6,100
|
|
|
10,777
|
|
|
14,211
|
|
Selling, general and
administrative
|
|
28,139
|
|
|
5,260
|
|
|
56,032
|
|
|
9,413
|
|
Intangible asset
amortization
|
|
|
617
|
|
|
372
|
|
|
1,182
|
|
|
741
|
|
|
Total operating
expenses
|
|
|
32,468
|
|
|
11,732
|
|
|
68,189
|
|
|
24,365
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from
operations
|
|
|
|
(21,606)
|
|
|
(3,413)
|
|
|
(48,184)
|
|
|
(7,978)
|
|
Other
income
|
|
|
|
31
|
|
|
30
|
|
|
76
|
|
|
76
|
Loss before tax
benefit
|
|
|
(21,575)
|
|
|
(3,383)
|
|
|
(48,108)
|
|
|
(7,902)
|
|
Tax
benefit
|
|
|
|
-
|
|
|
-
|
|
|
-
|
|
|
-
|
Net loss
|
|
|
$
|
(21,575)
|
|
$
|
(3,383)
|
|
$
|
(48,108)
|
|
$
|
(7,902)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per
share:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and
diluted
|
|
|
$
|
(0.64)
|
|
$
|
(0.12)
|
|
$
|
(1.42)
|
|
$
|
(0.28)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares used in
calculations of net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
per share:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and
diluted
|
|
|
|
33,874,625
|
|
|
28,377,254
|
|
|
33,777,207
|
|
|
28,361,340
|
|
(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 June
30, 2014.
|
(2) HETLIOZ® product
revenue is recognized upon delivery of product shipments to the
specialty pharmacies.
|
(3) Fanapt® licensing
agreement revenue reflects the amortization of the $200 million
upfront payment received from Novartis for the right to
commercialize and develop Fanapt® in the U.S. and
Canada.
|
VANDA
PHARMACEUTICALS INC.
|
CONDENSED
CONSOLIDATED BALANCE SHEETS (Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
($ in
thousands)
|
|
|
|
|
June 30,
2014
|
|
December 31,
2013 (1)
|
|
|
|
|
|
|
|
|
|
|
|
ASSETS
|
|
|
|
|
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
|
$
|
16,994
|
|
$
|
64,764
|
|
|
Marketable
securities
|
|
|
|
|
46,591
|
|
|
65,586
|
|
|
Accounts
receivable
|
|
|
|
|
2,376
|
|
|
2,031
|
|
|
Inventory
|
|
|
|
|
|
1,093
|
|
|
-
|
|
|
Prepaid expenses and
other current assets
|
|
|
4,166
|
|
|
2,703
|
|
|
Restricted
cash
|
|
|
|
|
-
|
|
|
530
|
|
|
|
Total current
assets
|
|
|
|
|
71,220
|
|
|
135,614
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Property and
equipment, net
|
|
|
|
2,312
|
|
|
2,198
|
|
Intangible asset,
net
|
|
|
|
|
11,855
|
|
|
5,037
|
|
Restricted cash,
non-current
|
|
|
|
785
|
|
|
500
|
|
|
|
Total
assets
|
|
|
|
$
|
86,172
|
|
$
|
143,349
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
|
|
|
|
Accounts
payable
|
|
|
|
$
|
248
|
|
$
|
661
|
|
|
Accrued
liabilities
|
|
|
|
|
6,753
|
|
|
5,180
|
|
|
Deferred
rent
|
|
|
|
|
|
234
|
|
|
221
|
|
|
Deferred
revenues
|
|
|
|
|
31,059
|
|
|
26,789
|
|
|
|
Total current
liabilities
|
|
|
|
38,294
|
|
|
32,851
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deferred rent,
non-current
|
|
|
|
2,853
|
|
|
2,888
|
|
|
Deferred revenues,
non-current
|
|
|
44,000
|
|
|
63,486
|
|
|
Other
liabilities
|
|
|
|
|
140
|
|
|
-
|
|
|
|
Total
liabilities
|
|
|
|
|
85,287
|
|
|
99,225
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders'
equity:
|
|
|
|
|
|
|
|
|
|
|
Common
stock
|
|
|
|
|
34
|
|
|
33
|
|
|
Additional paid-in
capital
|
|
|
|
|
357,119
|
|
|
352,240
|
|
|
Accumulated other
comprehensive income
|
|
|
10
|
|
|
21
|
|
|
Accumulated
deficit
|
|
|
|
|
(356,278)
|
|
|
(308,170)
|
|
|
|
Total stockholders'
equity
|
|
|
|
885
|
|
|
44,124
|
|
|
|
Total liabilities and
stockholders' equity
|
|
$
|
86,172
|
|
$
|
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 June
30, 2014.
|
INVESTOR CONTACT:
Chad Rubin
Vice President
The Trout Group
(646) 378-2947
crubin@troutgroup.com
SOURCE Vanda Pharmaceuticals Inc.