ROCKVILLE, Md., Oct. 30 /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 third quarter
ended September 30, 2008. Vanda reported research and development
(R&D) expenses in the third quarter of 2008 of $3.8 million,
compared to $5.5 million in the second quarter of 2008 and $13.9
million in the third quarter of 2007. The decrease in R&D
expenses in the third quarter of 2008 relative to the second
quarter of 2008 is primarily attributable to lower costs in the
Phase III tasimelteon (VEC-162) chronic primary insomnia clinical
trial for which Vanda announced top-line results in June of 2008.
The decrease in R&D expenses in the third quarter of 2008
relative to the third quarter of 2007 is attributable to lower
clinical trial costs in 2008 compared to costs from trials
conducted in 2007, and the $5.0 million milestone charge recorded
in the third quarter of 2007 resulting from the submission of the
New Drug Application (NDA) for iloperidone. Net loss was $10.9
million for the third quarter of 2008, compared to $13.5 million
for the second quarter of 2008 and $21.9 million for the third
quarter of 2007. Net loss per common share for the third quarter of
2008 was $0.41, compared to $0.51 for the second quarter of 2008
and $0.82 for the third quarter of 2007. As of September 30, 2008,
Vanda's cash, cash equivalents, and marketable securities totaled
approximately $51.7 million. As of September 30, 2008, Vanda had a
total of approximately 26.7 million shares of common stock
outstanding. OPERATIONAL HIGHLIGHTS On September 10, 2008, Vanda
met with the U.S. Food and Drug Administration (FDA) to discuss the
not-approvable action letter that the FDA issued to Vanda on July
25, 2008 regarding iloperidone. The FDA asked Vanda to provide a
complete response to the not-approvable letter highlighting
arguments made during the meeting. Vanda expects to submit the
complete response within the next few weeks. The timing or outcome
of any FDA review of the response is uncertain at this time. Vanda
has suspended all commercial and development activities pending
further review. Vanda has also reduced its cash burn and is
reviewing a number of options to further reduce expenses and cash
burn. FINANCIAL DETAILS Operating Expenses. Third 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 clinical
trials and research initiatives, totaled $3.8 million, compared to
$5.5 million in the second quarter of 2008 and $13.9 million in the
third quarter of 2007. The decrease in R&D expenses in the
third quarter of 2008 relative to the second quarter of 2008 is
primarily attributable to lower costs in the Phase III tasimelteon
chronic primary insomnia clinical trial for which Vanda reported
top-line results in June of 2008. The decrease in R&D expenses
in the third quarter of 2008 relative to the third quarter of 2007
is primarily attributable to lower clinical trial costs in the
third quarter of 2008 compared to the costs from trials conducted
in the third quarter of 2007 and the $5.0 million milestone charge
recorded in the third quarter of 2007 resulting from the submission
of the NDA for iloperidone. -- General and administrative (G&A)
expenses totaled $7.4 million in the third quarter of 2008,
compared to $8.5 million in the second quarter of 2008 and $9.6
million in the third quarter of 2007. The decrease in G&A
expenses in the third quarter of 2008 relative to the second
quarter of 2008 is primarily due to lower iloperidone
pre-commercial launch expenses. The decrease in G&A expenses in
the third quarter of 2008 relative to the third quarter of 2007 is
primarily due to lower employee stock-based compensation expense
and lower iloperidone pre-commercial launch expenses. -- Employee
stock-based compensation expense recorded in the third quarter of
2008 totaled $3.6 million. Of these non-cash charges, $0.5 million
was recorded as R&D expense and $3.1 million was recorded as
G&A expense. In the second quarter of 2008 and the third
quarter of 2007, total stock-based compensation was $4.0 million
and $5.2 million, respectively. The decrease in stock-based
compensation in the third quarter of 2008 relative to the second
quarter of 2008 and the third quarter of 2007 is primarily due to
the lower fair market value of options granted in 2008. -- Net loss
for the third quarter of 2008 was $10.9 million, compared to a net
loss of $13.5 million for the second quarter of 2008 and $21.9
million for the third quarter of 2007. -- Net loss per common share
for the third quarter of 2008 was $0.41, compared to $0.51 for the
second quarter of 2008 and $0.82 for the third quarter of 2007. --
Cash and marketable securities decreased by $13.9 million during
the third quarter of 2008. Changes included $10.9 million of net
losses, decreases in accrued R&D expenses and accounts payable
of $5.2 million, net increases in prepaid expenses of $0.9 million,
fixed asset purchases of $0.5 million offset by $3.7 million in
non-cash depreciation, amortization, and stock-based compensation
expenses and net increases in other working capital of $0.1
million. -- Vanda's cash, cash equivalents, and marketable
securities as of September 30, 2008 totaled approximately $51.7
million, compared to approximately $93.2 million as of December 31,
2007. FINANCIAL GUIDANCE Net loss for the year is expected to be
approximately $56 million, or approximately $2.10 per share.
Non-cash charges for 2008, consisting primarily of stock-based
compensation expense and depreciation and amortization, are
expected to total approximately $16.5 million. The total cash
balance at December 31, 2008 is expected to be approximately $44
million. Fourth quarter cash expenditures, consisting primarily of
administrative overhead, personnel costs, costs to complete ongoing
carcinogenicity studies, costs to complete stability studies for
iloperidone, regulatory consulting fees, and commercial
discontinuation costs, are expected to total approximately $7.5
million. To reduce expenses, Vanda has taken the following actions:
-- Reduced headcount from 52 full-time employees as of June 30,
2008 to 44 full-time employees as of October 30, 2008. In addition,
Vanda has eliminated four full-time contract commercial positions.
-- Discontinued all commercial activities. -- Suspended all
non-essential manufacturing and pre-clinical activities. As a
result of these initiatives, Vanda expects its operating cash burn
to decrease to approximated $3.6 million per quarter beginning in
the first quarter of 2009. These expenditures will consist
primarily of administrative overhead, personnel costs, costs to
complete an ongoing carcinogenicity study and regulatory consulting
fees. Vanda is also evaluating its development pipeline and a
number of options to further reduce expenses and cash burn. Vanda
will provide additional guidance as soon as its plans are more
definitive. 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. 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
(Part II, Item 1A) of Vanda's quarterly report on Form 10-Q for the
quarter ended June 30, 2008 (File No. 000-51863). In addition to
the risks described above and in Part II, Item 1A of Vanda's
quarterly report on Form 10-Q, 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 Nine Months Ended
September 30, September 30, September 30, September 30, 2008 2007
2008 2007 Revenues from services $- $- $- $- Operating expenses:
Research and development 3,792,424 13,874,248 20,375,998 34,660,132
General and administrative 7,400,263 9,647,646 24,814,462
23,330,570 Total operating expenses 11,192,687 23,521,894
45,190,460 57,990,702 Loss from operations (11,192,687)
(23,521,894) (45,190,460) (57,990,702) Interest income 323,476
1,514,708 1,630,238 4,608,143 Other income - 71,345 - 71,345 Total
other income, net 323,476 1,586,053 1,630,238 4,679,488 Loss before
tax provision (10,869,211) (21,935,841) (43,560,222) (53,311,214)
Tax provision - 7,660 - 10,070 Net loss $(10,869,211) $(21,943,501)
$(43,560,222) $(53,321,284) Basic and diluted net loss per share
attributable to common stockholders $(0.41) $(0.82) $(1.63) $(2.03)
Shares used in calculation of basic and diluted net loss per share
attributable to common stockholders 26,650,534 26,612,853
26,649,439 26,223,151 VANDA PHARMACEUTICALS INC. (A Development
Stage Enterprise) CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited)
September 30, 2008 December 31, 2007 ASSETS Current assets: Cash
and cash equivalents $41,438,719 $41,929,533 Marketable securities
10,224,854 43,243,960 Prepaid expenses, deposits and other current
assets 2,942,703 1,781,881 Total current assets 54,606,276
86,955,374 Marketable securities, long-term - 7,979,331 Property
and equipment, net 1,885,775 1,345,845 Deposits 150,000 150,000
Restricted cash 430,230 430,230 Total assets $57,072,281
$96,860,780 LIABILITIES AND STOCKHOLDERS' EQUITY Current
liabilities: Accounts payable $899,035 $2,988,069 Accrued expenses
3,082,442 9,789,738 Total current liabilities 3,981,477 12,777,807
Long-term liabilities: Deferred rent 496,774 354,042 Total
liabilities 4,478,251 13,131,849 Stockholders' equity: Common stock
26,653 26,653 Additional paid-in capital 270,279,679 257,600,368
Accumulated other comprehensive income (loss) (241,814) 12,176
Deficit accumulated during the development stage (217,470,488)
(173,910,266) Total stockholders' equity 52,594,030 83,728,931
Total liabilities and stockholders' equity $57,072,281 $96,860,780
VANDA PHARMACEUTICALS INC. (A Development Stage Enterprise)
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited) Nine
Months Ended September 30, September 30, 2008 2007 Cash flows from
operating activities: Net loss $(43,560,222) $(53,321,284)
Adjustments to reconcile net income to net cash used in operating
activities: Depreciation and amortization 403,141 446,806
Stock-based compensation 12,679,311 14,480,108 Loss on disposal of
assets (173) 27,017 Accretion of discount on investments (212,664)
(1,315,609) Changes in assets and liabilities: Prepaid expenses and
other current assets (1,160,103) (1,414,371) Accounts payable
(2,089,044) 660,697 Accrued expenses (6,708,552) 5,544,227 Deferred
grant revenue - (140,599) Other liabilities 142,732 13,258 Net cash
used in operating activities (40,505,574) (35,019,750) Cash flows
from investing activities: Purchases of property and equipment
(943,659) (249,728) Proceeds from sales of property and equipment -
119,054 Purchases of marketable securities (11,491,577)
(107,570,370) Proceeds from sales of marketable securities
10,373,251 - Maturities of marketable securities 42,060,000
60,395,000 Net cash provided by (used in) investing activities
39,998,015 (47,306,044) Cash flows from financing activities:
Proceeds from exercise of stock options and warrants - 103,176
Proceeds from issuance of common stock, net of issuance costs -
111,254,850 Net cash provided by financing activities - 111,358,026
Effect of foreign currency translation 16,745 (6,654) Net increase
(decrease) in cash and cash equivalents (490,814) 29,025,578 Cash
and cash equivalents, beginning of period 41,929,533 30,928,895
Cash and cash equivalents, end of period $41,438,719 $59,954,473
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