Expects Fanapta(TM) (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
/PRNewswire-FirstCall/ -- 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 Fanapta(TM) (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
Fanapta(TM) (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, http://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 Fanapta(TM), 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
Fanapta(TM) 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. 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. -- 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.
-- 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. -- 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
Fanapta(TM) 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 Fanapta(TM) 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.
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, Fanapta(TM) (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. VANDA PHARMACEUTICALS INC. (A
Development Stage Enterprise) CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS (Unaudited) Three Months Ended March 31, March 31, 2008
2007 Revenues from services $- $- Operating expenses: Research and
development 11,102,665 10,592,059 General and administrative
8,959,214 6,233,549 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 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 $(0.72) $(0.61) common stockholders Shares
used in calculation of basic and diluted net loss per share
attributable to common stockholders 26,648,344 25,340,455 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 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 DATASOURCE: Vanda Pharmaceuticals Inc.
CONTACT: Steven A. Shallcross, Senior Vice President, Chief
Financial Officer of Vanda Pharmaceuticals Inc., +1-240-599-4500
Web site: http://www.vandapharma.com/
Copyright
Vanda Pharmaceuticals (NASDAQ:VNDA)
과거 데이터 주식 차트
부터 6월(6) 2024 으로 7월(7) 2024
Vanda Pharmaceuticals (NASDAQ:VNDA)
과거 데이터 주식 차트
부터 7월(7) 2023 으로 7월(7) 2024