e8vk
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): November 2, 2009
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 |
(Commission File No.)
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(IRS Employer Identification No.) |
9605 Medical Center Drive
Suite 300
Rockville, Maryland 20850
(Address of principal executive offices and zip code)
Registrants telephone number, including area code: (240) 599-4500
Not Applicable
(Former Name or Former Address, if Changed Since Last Report)
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:
o |
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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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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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Item 2.02. Results of Operations and Financial Condition.
On November 2, 2009, Vanda Pharmaceuticals Inc. issued a press release relating to its results
of operations and financial condition for the third quarter ended September 30, 2009. 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, as amended (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, as amended, or the
Exchange Act, except as expressly set forth by specific reference in such a filing.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
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Exhibit No. |
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Description |
99.1 |
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Press release of Vanda Pharmaceuticals Inc. dated November 2, 2009. |
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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By: |
/s/ STEPHANIE R. IRISH
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Name: |
Stephanie R. Irish |
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Title: |
Acting Chief Financial Officer and Treasurer |
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Dated: November 2, 2009
exv99w1
Exhibit 99.1
Not For Immediate Release
Company Contact:
Stephanie R. Irish
Acting Chief Financial Officer
Vanda Pharmaceuticals Inc.
(240) 599-4500
stephanie.irish@vandapharma.com
Vanda Pharmaceuticals Reports Third Quarter 2009 Results
ROCKVILLE, MD. November 2, 2009 Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ: VNDA), a
biopharmaceutical company focused on the development and commercialization of clinical-stage
products for central nervous system disorders, today announced financial and operational results
for the third quarter ended September 30, 2009.
Vanda reported a net loss of $7.7 million for the third quarter of 2009, compared to $12.4 million
for the second quarter of 2009 and $10.9 million for the third quarter of 2008. Total expenses for
the third quarter of 2009 were $7.7 million, compared to $12.4 million for the second quarter of
2009 and $11.2 million for the third quarter of 2008. Research and development (R&D) expenses for
the third quarter of 2009 were $2.1 million, compared to $7.2 million for the second quarter of
2009 and $3.8 million for the third quarter of 2008. The decrease in R&D expenses in the third
quarter of 2009 relative to the second quarter of 2009 is primarily due to the regulatory
consulting fees accrued in the second quarter as a result of the approval of Fanapt (iloperidone)
by the U.S. Food and Drug Administration (FDA). The decrease in R&D expenses in the third quarter
of 2009 relative to the third quarter of 2008 is primarily due to the completion of the Phase III
clinical trial of tasimelteon in chronic primary insomnia in 2008.
As of September 30, 2009, Vandas cash, cash equivalents, and marketable securities totaled
approximately $20.7 million. As of September 30, 2009, a total of approximately 27.2 million
shares of Vanda common stock were outstanding. Net loss per common share for the third quarter of
2009 was $0.28, compared to $0.46 for the second quarter of 2009 and $0.41 for the third quarter of
2008.
OPERATIONAL HIGHLIGHTS
On October 12, 2009, Vanda entered into an amended and restated sublicense agreement with Novartis
Pharma AG (Novartis). The parties had originally entered into a sublicense agreement on June 4,
2004 pursuant to which Vanda obtained certain worldwide exclusive licenses from Novartis relating
to Fanapt. The agreement is subject to, and will become effective upon, clearance under the
Hart-Scott-Rodino Antitrust Improvements Act of 1976 (HSR Act), which is expected by the end of
2009.
Page 1 of 8
Pursuant to the agreement, Novartis will have exclusive commercialization rights to all
formulations of Fanapt in the U.S. and Canada. Except for two post-approval studies started by
Vanda prior to the execution date of the agreement, which Vanda is obligated to complete, Novartis
will be responsible for the further clinical development activities in the U.S. and Canada,
including the development of a long-acting injectable (or depot) formulation of Fanapt.
Pursuant to the terms of the agreement, Vanda will be entitled to an upfront payment of $200
million, which it expects to receive within 30 days after the effective date of the agreement.
Vanda will be eligible for additional payments totaling up to $265 million upon the achievement of
certain commercial and development milestones for Fanapt in the U.S. and Canada. Vanda will also
receive royalties, which, as a percentage of net sales, are in the low double-digits, on net sales
of Fanapt in the U.S. and Canada. In addition, Vanda will no longer be required to make any future
milestone payments with respect to sales of Fanapt or any future royalty payments with respect to
sales of Fanapt in the U.S. and Canada.
Vanda retains exclusive rights to Fanapt outside the U.S. and Canada and Vanda will have exclusive
rights to use any of Novartis data for Fanapt for developing and commercializing Fanapt outside
the U.S. and Canada. At Novartis option, the parties will enter into good faith discussions
relating to the co-commercialization of Fanapt outside of the U.S. and Canada or, alternatively,
Novartis will receive a royalty on net sales of Fanapt outside of the U.S. and Canada.
Vanda continued the clinical, regulatory and commercial evaluation for tasimelteon, a MT1/MT2
melatonin agonist, currently in Phase III stage of development.
FINANCIAL DETAILS
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Operating Expenses. Third quarter 2009 R&D expenses of $2.1 million consisted primarily of
$0.5 million of salaries and benefits, $0.7 million of non-cash stock based compensation costs
for R&D personnel,$0.2 million for the carcinogenicity study and $0.2 million in consulting
fees. This compares to $7.2 million for the second quarter of 2009 and $3.8 million for the
third quarter of 2008. The decrease in R&D expenses in the third quarter of 2009 relative to
the second quarter of 2009 is primarily due to the regulatory consulting fees accrued in the
second quarter as a result of the approval of Fanapt by the FDA. The decrease in R&D
expenses in the third quarter of 2009 relative to the third quarter of 2008 is primarily due
to the completion of the Phase III clinical trial of tasimelteon in chronic primary insomnia
in 2008. |
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General and administrative (G&A) expenses of $5.3 million for the third quarter of 2009
consisted primarily of $0.4 million of salaries and benefits and $2.6 million of non-cash
stock based compensation costs for G&A personnel, as well as $0.5 million of legal fees, $0.7
million of commercial costs and $0.2 million of insurance costs. This compares to $5.0
million for the second quarter of 2009 and $7.4 million for the third quarter of 2008. The
decrease in G&A expenses in the third quarter of 2009 relative to the third quarter of 2008 is
primarily due to lower stock-based compensation and commercial expenses. |
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Employee stock-based compensation expense recorded in the third quarter of 2009 totaled
$3.3 million. Of these non-cash charges, $0.7 million was recorded as R&D expense and $2.6
million was recorded as G&A expense. For the second quarter of 2009 and the third quarter of
2008, total stock-based compensation expense was $2.8 million and $3.6 million, respectively.
The increase in stock-based compensation expense in the third quarter of 2009 relative to the
second quarter of 2009 is the result of the issuance of additional non- |
Page 2 of 8
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qualified stock options in 2009. The decrease in stock-based compensation expense in the third
quarter of 2009 relative to the third quarter of 2008 is primarily due to a lower stock-based
compensation expense resulting from the workforce reduction in the fourth quarter of 2008. |
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Cash and marketable securities decreased by $8.3 million during the third quarter of 2009.
Changes included $7.7 million of net losses, increases of $0.5 million in inventory, decreases
in accrued expenses and accounts payable of $2.9 million, increases in prepaid expenses of
$1.5 million, offset by $3.9 million in non-cash depreciation, amortization, and stock-based
compensation expense and $0.4 million in proceeds from the exercise of stock options. |
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Vandas cash, cash equivalents and marketable securities as of September 30, 2009 totaled
approximately $20.7 million, compared to approximately $46.5 million as of December 31, 2008. |
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Net loss for the third quarter of 2009 was $7.7 million, compared to a net loss of $12.4
million for the second quarter of 2009 and a net loss of $10.9 million for the third quarter
of 2008. |
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Net loss per common share for the third quarter of 2009 was $0.28, compared to $0.46 for
the second quarter of 2009 and $0.41 for the third quarter of 2008. |
FINANCIAL GUIDANCE
Vanda is currently concentrating its efforts on the transition of the commercialization and
development rights to Fanapt in the U.S. and Canada to Novartis and expects to work closely on the
joint steering committee to assist in the anticipated commercial launch of Fanapt in the first
quarter of 2010. The transition includes all regulatory, manufacturing and post-marketing
commitments requested by the FDA. Under the terms of the agreement with Novartis, except for two
small post-approval studies started by Vanda prior to the execution date of the agreement, which
Vanda is obligated to complete, Novartis will be responsible for the further clinical development
activities in the U.S. and Canada, including the development and commercialization of a depot
formulation of Fanapt. In addition, the Company will also evaluate the regulatory path and
commercial opportunity for Fanapt outside the U.S. and Canada. Vanda will also continue the
clinical, regulatory and commercial evaluation for tasimelteon. The Company intends to operate on a
reduced spending plan with its fixed overhead costs expected to be approximately $2.5 million to $3
million per quarter.
CONFERENCE CALL
Vanda has scheduled a conference call for today, Monday, November 2, 2009, at 10:00 AM ET. During
the call, Mihael H. Polymeropoulos, M.D., President and CEO, and Stephanie Irish, Acting CFO, will
discuss quarterly results and other corporate activities. Investors can call 1-800-901-5247
(domestic) and 1-617-786-4501 (international) prior to the 10:00 AM start time and ask for the
Vanda Pharmaceuticals conference call hosted by Dr. Polymeropoulos (participant passcode 46702701).
A replay of the call will be available Monday, November 2, 2009, at 1:00 PM ET and will be
accessible until Monday, November 9, 2009, 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 87052099.
The conference call will be broadcast simultaneously on the companys 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
Page 3 of 8
necessary software. The call will also be archived on the Vanda Web site for a period of 30 days,
through December 2, 2009.
ABOUT VANDA PHARMACEUTICALS INC.:
Vanda Pharmaceuticals Inc. is a biopharmaceutical company focused on the development and
commercialization of clinical-stage products 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 Pharmaceuticals Inc.
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 companys forward-looking statements include, among others: the extent and
effectiveness of the development, sales and marketing and distribution support Fanapt receives;
Vandas ability to successfully commercialize Fanapt outside of the U.S. and Canada; delays in the
completion of Vandas clinical trials; a failure of Vandas products to be demonstrably safe and
effective; Vandas failure to obtain regulatory approval for its products or to comply with ongoing
regulatory requirements for its products; a lack of acceptance of Vandas products in the
marketplace, or a failure to become or remain profitable; Vandas expectations regarding trends
with respect to its costs and expenses; Vandas inability to obtain the capital necessary to fund
its commercial and research and development activities; Vandas failure to identify or obtain
rights to new products; Vandas failure to develop or obtain sales, marketing and distribution
resources and expertise or to otherwise manage its growth; a loss of any of Vandas key scientists
or management personnel; losses incurred from product liability claims made against Vanda; a loss
of rights to develop and commercialize Vandas products under its license and sublicense agreements
and other factors that are described in the Risk Factors section (Part II, Item 1A) of Vandas
quarterly report on Form 10-Q for the fiscal quarter ended June 30, 2009 (File No. 001-34186). In
addition to the risks described above and in Part II, Item 1A of Vandas quarterly report on Form
10-Q, other unknown or unpredictable factors also could affect Vandas 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.
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Page 4 of 8
VANDA PHARMACEUTICALS INC.
(A Development Stage Enterprise)
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited)
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Three Months Ended |
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Nine Months Ended |
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September 30, |
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September 30, |
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September 30, |
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September 30, |
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2009 |
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2008 |
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2009 |
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2008 |
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Revenue |
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$ |
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$ |
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$ |
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$ |
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Operating expenses: |
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Cost of sales |
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376,792 |
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606,143 |
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Research and development |
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2,091,984 |
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3,792,424 |
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11,620,918 |
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20,375,998 |
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General and administrative |
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5,266,434 |
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7,400,263 |
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14,478,786 |
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24,814,462 |
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Total operating expenses |
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7,735,210 |
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11,192,687 |
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26,705,847 |
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45,190,460 |
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Loss from operations |
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(7,735,210 |
) |
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(11,192,687 |
) |
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(26,705,847 |
) |
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(45,190,460 |
) |
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Interest income |
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9,842 |
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323,476 |
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84,391 |
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1,630,238 |
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Net loss |
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$ |
(7,725,368 |
) |
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$ |
(10,869,211 |
) |
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$ |
(26,621,456 |
) |
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$ |
(43,560,222 |
) |
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Basic and diluted net loss per
share attributable to
common stockholders |
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$ |
(0.28 |
) |
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$ |
(0.41 |
) |
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$ |
(0.99 |
) |
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$ |
(1.63 |
) |
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Shares used in calculation of
basic and diluted net loss
per share attributable to
common stockholders |
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27,196,694 |
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26,650,534 |
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26,920,742 |
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26,649,439 |
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Page 5 of 8
VANDA PHARMACEUTICALS INC.
(A Development Stage Enterprise)
CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited)
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September 30, 2009 |
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December 31, 2008 |
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ASSETS |
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Current assets: |
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Cash and cash equivalents |
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$ |
17,417,647 |
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$ |
39,079,304 |
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Marketable securities |
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3,265,175 |
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7,378,798 |
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Prepaid expenses, deposits and other current assets |
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2,632,783 |
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1,287,400 |
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Inventory |
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1,758,427 |
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Total current assets |
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25,074,032 |
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47,745,502 |
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Property and equipment, net |
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1,411,326 |
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1,758,111 |
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Restricted cash |
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430,230 |
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430,230 |
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Intangible asset, net |
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11,393,857 |
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Total assets |
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$ |
38,309,445 |
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$ |
49,933,843 |
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LIABILITIES AND STOCKHOLDERS EQUITY |
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Current liabilities: |
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Accounts payable |
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$ |
6,346,236 |
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$ |
512,382 |
|
Accrued expenses |
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|
2,046,028 |
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|
2,898,417 |
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Total current liabilities |
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8,392,264 |
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|
3,410,799 |
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Long-term liabilities: |
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Deferred rent |
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505,831 |
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|
502,770 |
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Total liabilities |
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8,898,095 |
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|
3,913,569 |
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Stockholders equity: |
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Common stock |
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27,202 |
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|
26,653 |
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Additional paid-in capital |
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|
280,980,068 |
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|
270,988,157 |
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Accumulated other comprehensive income (loss) |
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|
43 |
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|
(20,029 |
) |
Deficit accumulated during the development stage |
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(251,595,963 |
) |
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(224,974,507 |
) |
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Total stockholders equity |
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29,411,350 |
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|
46,020,274 |
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Total liabilities and stockholders equity |
|
$ |
38,309,445 |
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|
$ |
49,933,843 |
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Page 6 of 8
VANDA PHARMACEUTICALS INC.
(A Development Stage Enterprise)
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited)
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Nine Months Ended |
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September 30, |
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September 30, |
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2009 |
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2008 |
|
Cash flows from operating activities: |
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|
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Net loss |
|
$ |
(26,621,456 |
) |
|
$ |
(43,560,222 |
) |
Adjustments to reconcile net loss to net cash used
in operating activities: |
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|
|
|
|
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|
Depreciation and amortization |
|
|
346,785 |
|
|
|
403,141 |
|
Employee and non-employee stock-based compensation |
|
|
8,708,726 |
|
|
|
12,679,311 |
|
Loss on disposal of assets |
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|
|
|
|
|
(173 |
) |
Amortization of net discounts on short-term investments |
|
|
122,963 |
|
|
|
(212,664 |
) |
Amortization of intangible assets |
|
|
606,143 |
|
|
|
|
|
Changes in assets and liabilities: |
|
|
|
|
|
|
|
|
Prepaid expenses and other current assets |
|
|
(1,345,383 |
) |
|
|
(1,160,103 |
) |
Inventory |
|
|
(1,758,427 |
) |
|
|
|
|
Accounts payable |
|
|
833,854 |
|
|
|
(2,089,044 |
) |
Accrued expenses |
|
|
(852,389 |
) |
|
|
(6,708,552 |
) |
Other liabilities |
|
|
3,061 |
|
|
|
142,732 |
|
|
|
|
|
|
|
|
Net cash used in operating activities |
|
|
(19,956,123 |
) |
|
|
(40,505,574 |
) |
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Cash flows from investing activities: |
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|
|
Acquisition of intangible asset |
|
|
(7,000,000 |
) |
|
|
|
|
Purchases of property and equipment |
|
|
|
|
|
|
(943,659 |
) |
Purchases of marketable securities |
|
|
(11,365,815 |
) |
|
|
(11,491,577 |
) |
Proceeds from sales of marketable securities |
|
|
126,547 |
|
|
|
10,373,251 |
|
Maturities of marketable securities |
|
|
15,250,000 |
|
|
|
42,060,000 |
|
|
|
|
|
|
|
|
Net cash provided by (used in) investing activities |
|
|
(2,989,268 |
) |
|
|
39,998,015 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from financing activities: |
|
|
|
|
|
|
|
|
Proceeds from exercise of stock options, warrants
and restricted stock units |
|
|
1,283,734 |
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by financing activities |
|
|
1,283,734 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Effect of foreign currency translation |
|
|
|
|
|
|
16,745 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net change in cash and cash equivalents |
|
|
(21,661,657 |
) |
|
|
(490,814 |
) |
|
|
|
|
|
|
|
|
|
Cash and cash equivalents, beginning of period |
|
|
39,079,304 |
|
|
|
41,929,533 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents, end of period |
|
$ |
17,417,647 |
|
|
$ |
41,438,719 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental disclosure of non-cash investing activities |
|
|
|
|
|
|
|
|
Intangible asset acquisition included in accounts payable |
|
$ |
5,000,000 |
|
|
|
|
|
Page 7 of 8
SOURCE Vanda Pharmaceuticals Inc.
11/2/2009
CONTACT: Stephanie R. Irish, Acting 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