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): May 5, 2011
VANDA PHARMACEUTICALS INC.
(Exact name of Registrant as specified in its charter)
Delaware
(State or other jurisdiction of incorporation)
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001-34186
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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 Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17
CFR 240.14d-2(b))
o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17
CFR 240.13e-4(c))
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Item 2.02. |
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Results of Operations and Financial Condition. |
On May 5, 2011, Vanda Pharmaceuticals Inc. (the Company or Vanda) issued a press release
and held a conference call regarding its results of operations and financial condition for the
quarter ended March 31, 2011. The full text of the press release is furnished as Exhibit 99.1 to
this Current Report on Form 8-K.
Various statements made during the conference call were 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, 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 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, product candidates or partnered products to
be demonstrably safe and effective; Vandas failure to obtain regulatory approval for its products
or product candidates or to comply with ongoing regulatory requirements; a lack of acceptance of
Vandas products, product candidates or partnered 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 additional research and
development activities; Vandas failure to identify or obtain rights to new products or product
candidates; Vandas failure to develop or obtain sales, marketing and distribution resources and
expertise or to otherwise manage its growth; limitations on Vandas ability to utilize some or all
of its prior net operating losses and research and development credits; 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 or product candidates under
its license and sublicense agreements and other factors that are described in the Risk Factors
and Managements Discussion and Analysis of Financial Condition and Results of Operations
sections of Vandas Annual Report on Form 10-K for the fiscal year ended December 31, 2010 , which
is on file with the SEC and available on the SEC website at www.sec.gov. Additional information
will also be set forth in those sections of Vandas Quarterly Report on Form 10-Q for the quarter
ended March 31, 2011, which will be filed with the SEC in the second quarter of 2011. In addition
to the risks described above and in Vandas Annual Report on Form 10-K and Quarterly Reports 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 conveyed on the conference
call will be provided only as of the date of the call, and the Company undertakes no obligation,
and specifically declines any obligation, to update or revise publicly any forward-looking
statements made during the call after the date thereof, whether as a result of new information,
future events, or otherwise.
The information in Item 2.02 of this Current Report on 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.
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Item 9.01. |
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Financial Statements and 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 May 5, 2011. |
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/ James Kelly
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Name: |
James Kelly |
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Title: |
Chief Financial Officer |
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Dated: May 9, 2011
exv99w1
Exhibit 99.1
Company Contact:
Cristina Murphy
Communications Manager
Vanda Pharmaceuticals Inc.
(240) 599-4500
cristina.murphy@vandapharma.com
Vanda Pharmaceuticals Reports First Quarter 2011 Results
ROCKVILLE, MD. May 5, 2011 Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ: VNDA), a
biopharmaceutical company focused on the development and commercialization of products for central
nervous system disorders, today announced financial and operational results for the first quarter
ended March 31, 2011.
We are very excited about the significant progress we have made to date in 2011 said Mihael H.
Polymeropoulos, M.D., President and Chief Executive Officer. Our first product, Fanapt®, which is
marketed in the U.S. for the treatment of schizophrenia has now entered a Phase I study to evaluate
the safety and pharmacokinetic profiles of two different long-acting formulations in patients with
schizophrenia. In addition, we have expanded the tasimelteon clinical program with a Phase IIb/III
Study in Major Depression that will begin in the second half of 2011.
Key Highlights:
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Vanda recorded first quarter 2011 revenue of $7.5 million including royalties of $0.9
million. Fanapt® prescriptions, as reported by IMS, reached 25,000 in the first quarter of
2011. |
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Fanapt® long-acting injectable (depot) formulation advanced into clinical studies. |
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European filing for oral Fanapt® is targeted for the second half of 2011. |
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Tasimelteon program expanded to include a Phase IIb/III study in patients with Major
Depressive Disorder. Study expected to begin in the second half of 2011. |
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The European Commission (EC) granted orphan drug designation for tasimelteon for
Non-24-Hour Sleep/Wake Disorder (N24HSWD.) |
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Top-line efficacy results for tasimelteon for N24HSWD are expected in mid 2012; NDA
submission planned for the first half of 2013. |
Page 1 of 8
FIRST QUARTER 2011 REPORTED RESULTS
Total revenues for the first quarter of 2011 were $7.5 million, compared to $12.4 million for the
same period in 2010. First quarter 2011 revenues included $0.9 million related to Fanapt®
royalties received from Novartis as compared to $2.1 million for the first quarter of 2010. The
higher first quarter 2010 royalty revenue was the result of initial wholesaler stocking at launch.
First quarter 2010 revenues also included one-time product sales to Novartis of $3.7 million.
Total operating expenses for the first quarter of 2011 were $7.5 million, compared to $6.3 million
for the first quarter of 2010. The primary driver of the higher expenses in the first quarter of
2011 was the ongoing support of the tasimelteon N24HSWD clinical studies.
Net income was $0.1 million for the first quarter of 2011, compared to $0.5 million for the first
quarter of 2010. Basic and diluted earnings per share for the first quarter of 2011 were $0.00,
compared to $0.02 per share for the first quarter of 2010.
First Quarter 2011 Key Financial Figures1
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Three Months Ended |
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March 31 |
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December 31 |
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(in thousands, except per share amounts) |
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2011 |
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2010 |
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Change ($) |
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Change (%) |
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Total revenues |
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$ |
7,501 |
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$ |
7,752 |
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$ |
(251 |
) |
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-3 |
% |
Research
& development expenses |
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4,267 |
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3,822 |
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445 |
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12 |
% |
General & administrative expenses |
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2,858 |
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2,762 |
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96 |
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3 |
% |
Non-cash stock-based compensation2 |
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1,604 |
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1,335 |
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269 |
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20 |
% |
Net income (loss) before tax provision |
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142 |
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933 |
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(791 |
) |
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-85 |
% |
Tax provision (benefit) |
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6 |
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(1,266 |
) |
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1,272 |
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NA |
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Net income (loss) |
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136 |
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2,200 |
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(2,064 |
) |
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-94 |
% |
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Diluted net income (loss) per share |
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$ |
0.00 |
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$ |
0.08 |
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$ |
(0.08 |
) |
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-100 |
% |
Select Cash Flow Data1
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Three Months Ended |
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March 31 |
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March 31 |
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(In thousands) |
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2011 |
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2010 |
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Net cash provided by (used in) |
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Operating activities |
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(3,264 |
) |
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(4,826 |
) |
Investing activities |
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13,225 |
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(32,457 |
) |
Financing activities |
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1,933 |
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Net change in cash and cash equivalents |
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$ |
9,961 |
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$ |
(35,350 |
) |
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Select Balance Sheet Data1
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March 31 |
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December 31 |
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March 31 |
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(in thousands) |
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2011 |
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2010 |
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2010 |
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Total cash and marketable securities |
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$ |
194,555 |
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$ |
198,037 |
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$ |
202,424 |
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(1) |
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Unaudited |
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(2) |
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Non-cash stock-based compensation is allocated to both Research & development and General &
administrative expenses. |
Page 2 of 8
OPERATIONAL HIGHLIGHTS
First quarter 2011 sales of Fanapt® were reported by Novartis to be $9.0 million. Fanapt®
prescriptions, as reported by IMS, reached 25,000 in the first quarter of 2011.
Novartis initiated a clinical study for the once a month injectable depot formulation of Fanapt® in
April 2011. This is a Phase I study that will evaluate the safety and pharmacokinetic profiles of
two different long-acting formulations of Fanapt® in patients with schizophrenia. A long-acting
injectable formulation could offer a potential new option for patients with schizophrenia who might
benefit from less frequent dosing compared to an oral medication.
Vanda expects to file for European regulatory approval of oral Fanapt® in the second half of 2011.
This continues the effort to expand the availability of Fanapt® to markets outside the U.S. and
Canada.
On March 31, 2011, Vanda announced plans to evaluate tasimelteon in Major Depressive Disorder.
There is considerable evidence that suggests circadian rhythm disturbances are important in the
pathophysiology of mood disorders. Treatment with tasimelteon would represent a novel and
differentiated approach to assisting the millions of patients who suffer from the symptoms of major
depression. A Phase IIb/III clinical trial will examine safety and efficacy of tasimelteon versus
placebo and is expected to begin during the second half of 2011. The study will include an 8-week
treatment period and an optional open-label extension.
Enrollment is ongoing in tasimelteon studies VP-VEC-162-3201 (efficacy) and VP-VEC-162-3202
(safety) in the treatment of N24HSWD in totally blind individuals. Top line efficacy results are
expected in mid 2012 and an NDA submission is planned for the first half of 2013.
On March 8, 2011, tasimelteon was granted orphan drug designation by the European Commission (EC)
for the treatment of N24HSWD in totally blind individuals. Orphan designation for a medicinal
product by the EC provides benefits that can take a variety of forms including tax incentives,
protocol assistance, eligibility for grants and initiatives supporting research and development
related to this orphan indication, reduction of marketing application fees and annual fees for
qualifying companies, and potential marketing exclusivity for up to 10 years in the European Union.
REVISED FULL YEAR 2011 FINANCIAL GUIDANCE
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General and administrative expenses are expected to be between $10.0 and $12.0 million. |
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Research and development expenses are expected to be between $30.0 and $34.0 million. |
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Total U.S. GAAP operating expenses are expected to be between $41.0 and $47.0 million.
This includes $1.5 million related to amortization of an intangible asset and $5.0 to $6.0
million of stock-based compensation. |
Page 3 of 8
CONFERENCE CALL
Vanda has scheduled a conference call for today, Thursday, May 5, 2011, at 10:00 AM ET. During the
call, Mihael H. Polymeropoulos, M.D., President and CEO, and James P. Kelly, Senior Vice President
and Chief Financial Officer, will discuss the first quarter 2011 results and other corporate
activities. Investors can call 1-866-383-7998 (domestic) and 1-617-597-5329 (international) prior
to the 10:00 AM start time and ask for the Vanda Pharmaceuticals conference call hosted by Dr.
Polymeropoulos (participant passcode 44118664). A replay of the call will be available beginning
Thursday, May 5, 2011 at 1:00 PM ET and will be accessible until Thursday, May 12, 2011, 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 73214212.
The conference call will be broadcast simultaneously on Vandas website,
http://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 Vandas website for a period of 30
days, through June 3, 2011.
ABOUT VANDA PHARMACEUTICALS INC.:
Vanda Pharmaceuticals Inc. is a biopharmaceutical company focused on the development and
commercialization of products for central nervous system disorders. For more on Vanda, 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, 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 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, product candidates or
partnered products to be demonstrably safe and effective; Vandas failure to obtain regulatory
approval for its products, product candidates or partnered products or to comply with ongoing
regulatory requirements; a lack of acceptance of Vandas products, product candidates or partnered
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 additional research and development activities; Vandas failure to identify or
obtain rights to new products or product candidates; Vandas failure to develop or obtain sales,
marketing and distribution resources and expertise or to otherwise manage its growth; limitations
on Vandas ability to utilize some or all of its prior net operating losses and research and
development credits; 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 or product candidates under its license and sublicense agreements
and other factors that are described in the Risk Factors and Managements Discussion and
Analysis of Financial Condition and Results of Operations sections of Vandas annual report on
Form 10-K for the fiscal year ended December 31, 2010 which is on file with the SEC and available
on the SECs website at www.sec.gov. In addition to the risks described above and in Vandas
annual report on Form 10-K and quarterly reports 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
Page 4 of 8
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 5 of 8
VANDA PHARMACEUTICALS INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited)
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Three Months Ended |
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March 31, |
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March 31, |
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(In thousands, except for per share amounts) |
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2011 |
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2010 |
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Revenues: |
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Licensing agreement |
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$ |
6,606 |
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$ |
6,606 |
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Royalty revenue |
|
|
895 |
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|
|
2,067 |
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Product sales |
|
|
|
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|
|
3,748 |
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Total revenues |
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|
7,501 |
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|
12,421 |
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Operating expenses: |
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|
|
|
|
|
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Cost of sales product |
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|
|
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|
|
1,375 |
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Research and development |
|
|
4,267 |
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|
|
2,041 |
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General and administrative |
|
|
2,858 |
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|
|
2,489 |
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Intangible asset amortization |
|
|
369 |
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|
|
369 |
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|
|
|
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Total operating expenses |
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|
7,494 |
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|
6,274 |
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|
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|
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Income from operations |
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|
7 |
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|
|
6,147 |
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Other income: |
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Interest income |
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|
135 |
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|
|
47 |
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Total other income |
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135 |
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|
|
47 |
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Income before income tax provision |
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|
142 |
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|
|
6,194 |
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|
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|
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|
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Tax provision |
|
|
6 |
|
|
|
5,665 |
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|
|
|
|
|
|
|
|
|
|
|
|
|
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|
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Net income |
|
$ |
136 |
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|
$ |
529 |
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|
|
|
|
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|
|
|
|
|
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Net income per share: |
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|
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|
|
Basic and diluted |
|
$ |
0.00 |
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|
$ |
0.02 |
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|
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Shares used in calculation of net income
per share: |
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Basic |
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|
28,101,418 |
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|
|
27,704,418 |
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|
|
|
|
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Diluted |
|
|
28,936,835 |
|
|
|
28,318,754 |
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|
|
|
|
|
|
|
|
|
|
|
|
|
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Page 6 of 8
VANDA PHARMACEUTICALS INC.
CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited)
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(In thousands) |
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March 31, 2011 |
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December 31, 2010 |
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ASSETS |
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Current assets: |
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|
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Cash and cash equivalents |
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$ |
52,520 |
|
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$ |
42,559 |
|
Marketable securities |
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|
142,035 |
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|
|
155,478 |
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Accounts receivable |
|
|
895 |
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|
|
511 |
|
Prepaid expenses, deposits and other current assets |
|
|
1,619 |
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|
|
1,843 |
|
Deferred tax, current |
|
|
182 |
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|
|
182 |
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|
|
|
|
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Total current assets |
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|
197,251 |
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|
|
200,573 |
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|
|
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Property and equipment, net |
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|
860 |
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|
937 |
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Intangible asset, net |
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|
9,153 |
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|
9,522 |
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Deferred tax, non-current |
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|
1,639 |
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|
1,639 |
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Restricted cash |
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|
430 |
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|
|
430 |
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Total assets |
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$ |
209,333 |
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$ |
213,101 |
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LIABILITIES AND STOCKHOLDERS EQUITY |
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Current liabilities: |
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Accounts payable |
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$ |
834 |
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$ |
648 |
|
Accrued liabilities |
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|
2,141 |
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|
|
1,324 |
|
Accrued income taxes |
|
|
2,272 |
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|
|
2,266 |
|
Deferred revenue, current |
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|
26,789 |
|
|
|
26,789 |
|
|
|
|
|
|
|
|
Total current liabilities |
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|
32,036 |
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|
|
31,027 |
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|
|
|
|
|
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Long-term liabilities: |
|
|
|
|
|
|
|
|
Deferred rent |
|
|
482 |
|
|
|
490 |
|
Deferred revenue, non-current |
|
|
137,247 |
|
|
|
143,853 |
|
|
|
|
|
|
|
|
Total liabilities |
|
|
169,765 |
|
|
|
175,370 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders equity: |
|
|
|
|
|
|
|
|
Common stock |
|
|
28 |
|
|
|
28 |
|
Additional paid-in capital |
|
|
292,946 |
|
|
|
291,342 |
|
Accumulated other comprehensive income |
|
|
99 |
|
|
|
2 |
|
Accumulated deficit |
|
|
(253,505 |
) |
|
|
(253,641 |
) |
|
|
|
|
|
|
|
Total stockholders equity |
|
|
39,568 |
|
|
|
37,731 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities and stockholders equity |
|
$ |
209,333 |
|
|
$ |
213,101 |
|
|
|
|
|
|
|
|
Page 7 of 8
SOURCE Vanda Pharmaceuticals Inc.
CONTACT: Cristina Murphy, Communications Manager, of Vanda Pharmaceuticals Inc., +1-240-599-4500
Web site: http://www.vandapharma.com
(VNDA)
CO: Vanda Pharmaceuticals Inc.
Page 8 of 8