UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM 8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of
the
Securities Exchange Act of 1934
Date
of
Report (Date of earliest event reported): May 1, 2008
VANDA
PHARMACEUTICALS INC.
(Exact
name of Registrant as specified in its charter)
Delaware
(State
or
other jurisdiction of incorporation)
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000-51863
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03-0491827
|
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(Commission
File No.)
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(IRS
Employer Identification No.)
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9605
Medical Center Drive
Suite 300
Rockville,
Maryland 20850
(Address
of principal executive offices and zip code)
Registrant’s
telephone number, including area code: (240)
599-4500
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Not
Applicable
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(Former
Name or Former Address, if Changed Since Last
Report)
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Check
the
appropriate box below if the Form 8-K filing is intended to simultaneously
satisfy the filing obligation of the registrant under any of the following
provisions:
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o
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Written
communications pursuant to Rule 425 under the Securities Act (17 CFR
230.425)
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o
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Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
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o
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Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act
(17 CFR 240.14d-2(b))
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o
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Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act
(17 CFR 240.13e-4(c))
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On
May 1,
2008, Vanda Pharmaceuticals Inc. issued a press release relating to its results
of operations and financial condition for the first quarter ended March 31,
2008. The full text of this press release is furnished as Exhibit 99.1 to
this Current Report on Form 8-K.
The
information in Item 2.02 of this Form 8-K and the Exhibit attached
hereto shall not be deemed “filed” for purposes of Section 18 of the
Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the
liabilities of that section, nor shall it be deemed incorporated by reference
in
any filing under the Securities Act of 1933 or the Exchange Act, except as
expressly set forth by specific reference in such a filing.
| Item 9.01. |
Financial
Statements and Exhibits.
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| (d) |
Exhibits
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Exhibit No.
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|
Description
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99.1
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Press
release of Vanda Pharmaceuticals Inc. dated May 1,
2008.
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SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant
has
duly caused this report to be signed on its behalf by the undersigned hereunto
duly authorized.
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VANDA
PHARMACEUTICALS INC.
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||
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By:
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/s/
STEVEN
A. SHALLCROSS
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Name:
Steven A. Shallcross
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Title:
Senior Vice President, Chief Financial Officer and
Treasurer
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Dated:
May 1, 2008
For
Immediate Release
Company
Contact:
Steven
A.
Shallcross
Senior
Vice President & CFO
Vanda
Pharmaceuticals Inc..
(240)
599-4500
steven.shallcross@vandapharma.com
Vanda
Pharmaceuticals Reports First Quarter 2008 Results
Expects
FanaptaTM
(iloperidone) PDUFA Action July 27, 2008;
Tasimelteon
(VEC-162) Phase III Trial Results Expected in June;
Analyst
Day Planned for May 6th
in
Washington, DC at the American Psychiatric Association (APA) Annual Meeting
ROCKVILLE,
MD.
- May 1,
2008 - Vanda Pharmaceuticals Inc. (NASDAQ: VNDA),
a
biopharmaceutical company focused on the development and commercialization
of
clinical-stage product candidates for central nervous system disorders, today
announced financial and operational results for the first quarter ended March
31, 2008.
Vanda
reported research and development (R&D) expenses in the first quarter of
2008 of $11.1 million, compared to fourth quarter of 2007 R&D expenses of
$12.6 million and first quarter of 2007 R&D expenses of $10.6 million. The
decrease in R&D expenses in the first quarter of 2008 relative to the fourth
quarter of 2007 is primarily attributable to lower tasimelteon (VEC-162)
clinical program costs including the ongoing Phase III tasimelteon chronic
primary insomnia clinical trial for which Vanda plans to report the top-line
results in June of 2008. The increase in R&D expenses in the first quarter
of 2008 relative to the first quarter of 2007 is primarily attributable to
the
same tasimelteon Phase III trial that was initiated in late 2007.
Net
loss
was $19.2 million for the first quarter of 2008, compared to $20.7 million
in
the fourth quarter of 2007 and $15.4 million in the first quarter of 2007.
Net
loss per common share for the first quarter of 2008 was $0.72, compared to
$0.78
in the fourth quarter of 2007, and $0.61 in the first quarter of
2007.
As
of
March 31, 2008, Vanda’s cash, cash equivalents, and marketable securities
totaled approximately $77.0 million. As of March 31, 2008, the company had
a
total of approximately 26.6 million shares of common stock
outstanding.
OPERATIONAL
HIGHLIGHTS
FanaptaTM
(iloperidone)
On
September 27, 2007, Vanda announced that it had submitted a New Drug Application
(NDA) to the U.S. Food and Drug Administration (FDA) for FanaptaTM
(formerly referred to as Fiapta), its investigational atypical antipsychotic
for
the treatment of schizophrenia. On November 27, 2007 the company announced
that
the FDA had accepted and filed the NDA. Under the Prescription Drug User Fee
Act
(PDUFA) of 1992, Vanda expects a PDUFA action on or about July 27,
2008.
Tasimelteon
(VEC-162)
As
previously announced, Vanda has completed enrollment for its tasimelteon Phase
III chronic primary insomnia clinical trial. Vanda expects to report top-line
results in June 2008. Vanda enrolled 324 patients in the trial, which is a
randomized, double-blind, placebo-controlled 35-day study, measuring sleep
onset
and maintenance, as well as next-day performance.
Analyst
Day Announcement
Vanda
will host an Analyst Day on Tuesday, May 6, 2008 in Washington, D.C. at the
American Psychiatric Association (APA) Annual Meeting, beginning at 6:30 p.m.
ET. Vanda management and key opinion leaders in the field of schizophrenia
will
discuss the company’s development and commercial plans and recently presented
poster data.
Interested
parties are invited to listen and view a live webcast of this event from 6:30
p.m. ET to approximately 8:00 p.m. ET on Tuesday, May 6, 2008 on the company's
Web site, www.vandapharma.com.
Investors should go to the Web site at least 15 minutes early to register,
download, and install any necessary audio software. A webcast replay will be
available for 90 days following the live event.
FINANCIAL
DETAILS
|
·
|
Operating
Expenses. First quarter 2008 R&D expenses, primarily consisting of
salaries and related costs of R&D personnel, stock-based compensation,
and the costs of consultants, materials and supplies associated with
the
company’s clinical trials and research initiatives, were $11.1 million,
down from $12.6 million in the previous quarter and up from $10.6
million
in the first quarter of 2007. The decrease in R&D expenses in the
first quarter of 2008 relative to the fourth quarter of 2007 is primarily
attributable to lower tasimelteon clinical program costs including
the
ongoing Phase III chronic primary insomnia clinical trial for which
Vanda
plans to report the top-line results in June of 2008. The increase
in
R&D expenses in the first quarter of 2008 relative to the first
quarter of 2007 is primarily attributable to the same tasimelteon
Phase
III trial that was initiated in late 2007. In the first quarter of
2007
R&D expenses were attributable to FanaptaTM,
tasimelteon and VSF-173 clinical trial costs for programs that were
primarily conducted in 2006 and completed in early 2007.
|
General
and administrative (G&A) expenses totaled $9.0 million in the first quarter
of 2008, down from $9.5 million in the fourth quarter of 2007, and up from
$6.2
million in the first quarter of 2007. The decrease in G&A expenses in the
first quarter of 2008 relative to the fourth quarter of 2007 is primarily due
to
lower costs for FanaptaTM
pre-launch commercial activities. The increase in G&A expenses in the first
quarter of 2008 relative to the first quarter of 2007 is primarily due to
increased stock-based compensation charges, salaries and related costs of
non-R&D personnel, marketing, insurance, and facilities
expenses.
Page
2 of 8
Employee
stock-based compensation expense recorded in the first quarter of 2008 was
$5.1
million. Of the total $5.1 million of non-cash charges, $1.1 million was
recorded in R&D expenses and $4.0 million was recorded in G&A expenses.
In the fourth quarter of 2007 and the first quarter of 2007, total stock-based
compensation was $5.2 million and $4.0 million, respectively. The increase
in
stock-based compensation from the first quarter of 2008 and the fourth quarter
of 2007 compared to the first quarter of 2007 is primarily the result of the
higher fair value of options granted during 2007 compared to options granted
in
prior periods.
|
·
|
Net
loss for the first quarter of 2008 was $19.2 million. This compares
to a
net loss of $20.7 million in the fourth quarter of 2007, and $15.4
million
in the first quarter of 2007.
|
|
·
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Net
loss per common share for the first quarter of 2008 was $0.72, compared
to
$0.78 in the fourth quarter of 2007 and $0.61 in the first quarter
of
2007.
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|
·
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Cash
and marketable securities decreased by $16.2 million during the first
quarter of 2008. Changes included $19.2 million of net losses and
decreases in accrued R&D expenses and accounts payable of $2.7
million, fixed asset purchases of $0.2 million offset by $5.2 million
in
non-cash depreciation, amortization, and stock-based compensation
expenses, decreases in prepaid expenses of $0.6 million and net decreases
in other working capital of $0.1 million.
|
|
·
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Vanda’s
cash, cash equivalents, and marketable securities at the end of the
first
quarter of 2008 totaled approximately $77.0 million, compared to
approximately $93.2 million as of December 31, 2007.
|
FINANCIAL
GUIDANCE
The
company reaffirms its prior guidance and anticipates that its current cash
balance will be sufficient to fund operations through the FanaptaTM
PDUFA
action date and into the fourth quarter of 2008. Vanda plans to focus its
efforts primarily on completing and reporting the top-line results for the
ongoing tasimelteon Phase III chronic primary insomnia clinical trial and
continuing essential FanaptaTM
pre-launch commercial activities.
CONFERENCE
CALL
The
company has scheduled a conference call for today, Thursday, May 1, 2008 at
10:30 AM ET. During the call, Mihael H. Polymeropoulos, M.D., President and
CEO,
and Steven A. Shallcross, Sr. Vice President and CFO, will discuss quarterly
results and other corporate activities. Investors can call 1-866-510-0710
(domestic) and 1-617-597-5378 (international) prior to the 10:30 AM start time
and ask for the Vanda Pharmaceuticals conference call hosted by Dr.
Polymeropoulos. A replay of the call will be available Thursday, May 1, 2008,
at
12:30 PM ET and will be accessible until Thursday, May 8, 2008, at 5:00 PM
ET.
The replay call-in number is 1-888-286-8010 for domestic callers and
1-617-801-6888 for international callers. The access number is 34135192.
The
conference call will be broadcast simultaneously on the company's Web site,
http://www.vandapharma.com.
Investors should click on the Investor Relations tab and are advised to go
to
the Web site at least 15 minutes early to register, download, and install any
necessary software. The call will also be archived on the Vanda Web site for
a
period of 30 days, through May 30, 2008.
Page
3 of 8
ABOUT
VANDA PHARMACEUTICALS INC.:
Vanda
Pharmaceuticals Inc. is a biopharmaceutical company focused on the development
and commercialization of clinical-stage product candidates for central nervous
system disorders. The company has three product candidates. Vanda's lead product
candidate, FanaptaTM
(iloperidone),
is a compound for the treatment of schizophrenia and bipolar disorder, for
which
Vanda has recently submitted an NDA to the FDA. Vanda's second product
candidate, tasimelteon (VEC-162), is a compound for the treatment of sleep
and
mood disorders, which is currently in Phase III for chronic primary insomnia.
Vanda's third product candidate, VSF-173, is a compound for the treatment of
excessive sleepiness in Phase II. For more on Vanda Pharmaceuticals Inc., please
visit http://www.vandapharma.com.
CAUTIONARY
NOTE REGARDING FORWARD-LOOKING STATEMENTS
Various
statements in this release are “forward-looking statements” under the securities
laws. Words such as, but not limited to, “believe,” “expect,” “anticipate,”
“estimate,” “intend,” “plan,” “targets,” “likely,” “will,” “would,” and “could,”
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. Vanda is at
an
early stage of development and may not ever have any products that generate
significant revenue. Important factors that could cause actual results to differ
materially from those reflected in the company’s forward-looking statements
include, among others: delays
in
the completion of Vanda’s clinical trials; a
failure
of Vanda’s product candidates to be demonstrably safe and effective;
Vanda’s
failure to obtain regulatory approval for its products or to comply with ongoing
regulatory requirements; a
lack of
acceptance of Vanda’s product candidates in the marketplace, or a failure to
become or remain profitable; Vanda’s
inability to obtain the capital necessary to fund its research and development
activities; Vanda’s
failure to identify or obtain rights to new product candidates; Vanda’s
failure to develop or obtain sales, marketing and distribution resources and
expertise or to otherwise manage its growth; a
loss of
any of Vanda’s key scientists or management personnel; losses
incurred from product liability claims made against Vanda; a
loss of
rights to develop and commercialize Vanda’s products under its license and
sublicense agreements and other factors that are described in the “Risk Factors”
section (Item 1A) of Vanda’s annual report on Form 10-K for the year ended
December 31, 2007 (File No. 000-51863). In addition to the risks described
above
and in Item 1A of Vanda’s annual report on Form 10-K, 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.
####
Page
4 of 8
VANDA
PHARMACEUTICALS INC.
(A
Development Stage Enterprise)
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited)
|
Three
Months Ended
|
|||||||
|
March
31,
|
March
31,
|
||||||
|
2008
|
2007
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||||||
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Revenues
from services
|
$
|
-
|
$
|
-
|
|||
|
Operating
expenses:
|
|||||||
|
Research
and development
|
11,102,665
|
10,592,059
|
|||||
|
General
and administrative
|
8,959,214
|
6,233,549
|
|||||
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Total
operating expenses
|
20,061,879
|
16,825,608
|
|||||
|
Loss
from operations
|
(20,061,879
|
)
|
(16,825,608
|
)
|
|||
|
Interest
income
|
865,750
|
1,433,654
|
|||||
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Total
other income, net
|
865,750
|
1,433,654
|
|||||
|
Loss
before tax provision
|
(19,196,129
|
)
|
(15,391,954
|
)
|
|||
|
Tax
provision
|
-
|
806
|
|||||
|
Net
loss
|
$
|
(19,196,129
|
)
|
$
|
(15,392,760
|
)
|
|
|
|
|||||||
|
Basic
and diluted net loss per share
attributable to common
stockholders
|
$
|
(0.72
|
)
|
$
|
(0.61
|
)
|
|
|
|
|||||||
|
Shares
used in calculation of basic and diluted net loss per share attributable
to common stockholders
|
26,648,344
|
25,340,455
|
|||||
Page
5 of 8
VANDA
PHARMACEUTICALS INC.
(A
Development Stage Enterprise)
CONDENSED
CONSOLIDATED BALANCE SHEETS (Unaudited)
|
March
31, 2008
|
December
31, 2007
|
||||||
|
ASSETS
|
|||||||
|
Current
assets:
|
|||||||
|
Cash
and cash equivalents
|
$
|
56,015,493
|
$
|
41,929,533
|
|||
|
Marketable
securities
|
15,028,210
|
43,243,960
|
|||||
|
Prepaid
expenses, deposits and other current assets
|
1,176,179
|
1,781,881
|
|||||
|
Total
current assets
|
72,219,882
|
86,955,374
|
|||||
|
Marketable
securities, long-term
|
5,994,202
|
7,979,331
|
|||||
|
Property
and equipment, net
|
1,602,025
|
1,345,845
|
|||||
|
Deposits
|
150,000
|
150,000
|
|||||
|
Restricted
cash
|
430,230
|
430,230
|
|||||
|
Total
assets
|
$
|
80,396,339
|
$
|
96,860,780
|
|||
|
LIABILITIES
AND STOCKHOLDERS' EQUITY
|
|||||||
|
Current
liabilities:
|
|||||||
|
Accounts
payable
|
$
|
1,825,933
|
$
|
2,988,069
|
|||
|
Accrued
expenses
|
8,491,785
|
9,789,738
|
|||||
|
Total
current liabilities
|
10,317,718
|
12,777,807
|
|||||
|
Long-term
liabilities:
|
|||||||
|
Deferred
rent
|
422,407
|
354,042
|
|||||
|
Total
liabilities
|
10,740,125
|
13,131,849
|
|||||
|
Stockholders'
equity:
|
|||||||
|
Common
stock
|
26,653
|
26,653
|
|||||
|
Additional
paid-in capital
|
262,706,082
|
257,600,368
|
|||||
|
Accumulated
other comprehensive income (loss)
|
29,874
|
12,176
|
|||||
|
Deficit
accumulated during the development stage
|
(193,106,395
|
)
|
(173,910,266
|
)
|
|||
|
Total
stockholders' equity
|
69,656,214
|
83,728,931
|
|||||
|
Total
liabilities and stockholders' equity
|
$
|
80,396,339
|
$
|
96,860,780
|
|||
Page
6 of 8
VANDA
PHARMACEUTICALS INC.
(A
Development Stage Enterprise)
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited)
|
Three
Months Ended
|
|||||||
|
March
31,
|
March
31,
|
||||||
|
2008
|
2007
|
||||||
|
Cash
flows from operating activities:
|
|||||||
|
Net
loss
|
$
|
(19,196,129
|
)
|
$
|
(15,392,760
|
)
|
|
|
Adjustments
to reconcile net income to net cash used in operating
activities:
|
|||||||
|
Depreciation
and amortization
|
122,629
|
148,671
|
|||||
|
Stock-based
compensation
|
5,105,714
|
4,107,972
|
|||||
|
Loss
on disposal of assets
|
610
|
-
|
|||||
|
Accretion
of discount on investments
|
(162,519
|
)
|
(230,268
|
)
|
|||
|
Changes
in assets and liabilities:
|
|||||||
|
Prepaid
expenses and other current assets
|
606,421
|
109,921
|
|||||
|
Accounts
payable
|
(1,355,101
|
)
|
(767,846
|
)
|
|||
|
Accrued
expenses
|
(1,299,209
|
)
|
(1,419,185
|
)
|
|||
|
Other
liabilities
|
68,365
|
38,361
|
|||||
|
Net
cash used in operating activities
|
(16,109,219
|
)
|
(13,405,134
|
)
|
|||
|
Cash
flows from investing activities:
|
|||||||
|
Purchases
of property and equipment
|
(186,442
|
)
|
(118,678
|
)
|
|||
|
Purchases
of marketable securities
|
(1,485,150
|
)
|
(65,477,330
|
)
|
|||
|
Proceeds
from sales of marketable securities
|
2,790,026
|
-
|
|||||
|
Maturities
of marketable securities
|
29,060,000
|
950,000
|
|||||
|
Net
cash provided by (used in) investing activities
|
30,178,434
|
(64,646,008
|
)
|
||||
|
Cash
flows from financing activities:
|
|||||||
|
Proceeds
from exercise of stock options and warrants
|
-
|
56,516
|
|||||
|
Proceeds
from issuance of common stock, net of issuance
costs
|
-
|
111,291,219
|
|||||
|
Net
cash provided by financing activities
|
-
|
111,347,735
|
|||||
|
Effect
of foreign currency translation
|
16,745
|
(4,150
|
)
|
||||
|
Net
increase in cash and cash equivalents
|
14,085,960
|
33,292,443
|
|||||
|
Cash
and cash equivalents, beginning of period
|
41,929,533
|
30,928,895
|
|||||
|
Cash
and cash equivalents, end of period
|
$
|
56,015,493
|
$
|
64,221,338
|
|||
Page
7 of 8
SOURCE
Vanda Pharmaceuticals Inc.
5/1/2008
CONTACT:
Steven A. Shallcross, Senior Vice President, Chief Financial Officer of Vanda
Pharmaceuticals Inc., +1-240-599-4500
Web
site:
http://www.vandapharma.com
(VNDA)
CO:
Vanda
Pharmaceuticals Inc.
Page
8 of 8