Full Press Release Details
Communications Manager
Vanda Pharmaceuticals Inc.
Vanda Pharmaceuticals Reports Second Quarter 2011 Results
ROCKVILLE, MD. August 4, 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 second
quarter and six months ended June 30, 2011.
We are pleased with our progress towards our vision of building a CNS specialty pharmaceutical
company. Fanapt scripts in the U.S. continued to grow, and we have made advances
towards the globalization of the franchise. We are excited about the prospects of our tasimelteon
programs in both Non-24 and major depression, which are currently underway. said Mihael
Polymeropoulos, M.D., President and Chief Executive Officer.
SECOND QUARTER 2011 REPORTED RESULTS
Total revenues for the second quarter of 2011 were $7.4 million, compared to $8.3 million for the
same period in 2010. Second quarter 2011 revenues included $0.8 million related to Fanapt
royalties received from Novartis as compared to $0.1 million for the second quarter of 2010.
Second quarter 2011 sales of Fanapt as reported by Novartis included a $2.7 million cumulative
adjustment to gross to net sales reserves that resulted in approximately $270 thousand less in
royalties to Vanda in the period. Second quarter 2010 revenues also included one-time product sales
to Novartis of $1.5 million. Total operating expenses for the second quarter of 2011 were $8.9
million, compared to $7.1 million for the second quarter of 2010. The primary driver of the higher
expenses in the second quarter of 2011 was the ongoing support of the tasimelteon N24HSWD clinical
A net loss of $1.3 million was recorded for the second quarter of 2011, compared to net income of
$1.3 million for the second quarter of 2010. Diluted net loss per share for the second quarter of
2011 was $0.05, compared to diluted net income of $0.04 per share for the second quarter of 2010.
Year to date June 30, 2011 Key Financial Figures1
| Six Months Ending | ||||||||||||||||
| June 30 | June 30 | |||||||||||||||
| (in thousands, except per share amounts) | 2011 | 2010 | Change ($) | Change (%) | ||||||||||||
| Total revenues | $ | 14,931 | $ | 20,711 | $ | (5,780 | ) | -28 | % | |||||||
| Research development expenses | 10,266 | 4,444 | 5,822 | 131 | % | |||||||||||
| General administrative expenses | 5,430 | 5,331 | 99 | 2 | % | |||||||||||
| Non-cash stock-based compensation 2 | 2,929 | 2,760 | 169 | 6 | % | |||||||||||
| Income (loss) before tax provision | (1,250 | ) | 7,437 | (8,687 | ) | -117 | % | |||||||||
| Tax provision (benefit) | (45 | ) | 5,268 | (5,313 | ) | -101 | % | |||||||||
| Net income (loss) | (1,205 | ) | 1,809 | (3,014 | ) | -167 | % | |||||||||
| Diluted net income (loss) per share | $ | (0.04 | ) | $ | 0.06 | $ | (0.10 | ) | -167 | % |
Second Quarter 2011 Key Financial Figures1
| Three Months Ended | ||||||||||||||||
| June 30 | March 31 | |||||||||||||||
| (in thousands, except per share amounts) | 2011 | 2011 | Change ($) | Change (%) | ||||||||||||
| Total revenues | $ | 7,430 | $ | 7,501 | $ | (71 | ) | -1 | % | |||||||
| Research development expenses | 5,999 | 4,267 | 1,732 | 41 | % | |||||||||||
| General administrative expenses | 2,572 | 2,858 | (286 | ) | -10 | % | ||||||||||
| Non-cash stock-based compensation 2 | 1,325 | 1,604 | (279 | ) | -17 | % | ||||||||||
| Income (loss) before tax provision | (1,392 | ) | 142 | (1,534 | ) | NA | ||||||||||
| Tax provision (benefit) | (51 | ) | 6 | (57 | ) | NA | ||||||||||
| Net income (loss) | (1,341 | ) | 136 | (1,477 | ) | NA | ||||||||||
| Diluted net income (loss) per share | $ | (0.05 | ) | $ | 0.00 | $ | (0.05 | ) | NA |
Select Cash Flow Data1
| Six Months Ending | ||||||||
| June 30 | June 30 | |||||||
| (in thousands) | 2011 | 2010 | ||||||
| Net cash provided by (used in) | ||||||||
| Operating activities | (8,883 | ) | (728 | ) | ||||
| Investing activities | 16,710 | (61,311 | ) | |||||
| Financing activities | 2,395 | |||||||
| Net change in cash and cash equivalents | $ | 7,827 | $ | (59,644 | ) |
Select Balance Sheet Data1
| June 30 | March 31 | June 30 | ||||||||||
| (in thousands) | 2011 | 2011 | 2010 | |||||||||
| Total cash and marketable securities | $ | 188,399 | $ | 194,555 | $ | 207,117 |
| (1) | Unaudited | |
| (2) | Non-cash stock-based compensation is allocated to both Research development and General administrative expenses |
OPERATIONAL HIGHLIGHTS
Fanapt prescriptions, as reported by IMS, reached 30,000 in the second quarter of 2011.
This represents a 17% increase over first quarter 2011 prescriptions. Since its launch in January
2010, over 110,000 Fanapt prescriptions have been written in the U.S.
Vanda continues its effort to expand the availability of Fanapt to markets outside the
U.S. and Canada. On July 22, 2011, the European Medicines Agency (EMA) notified Vanda that it had
accepted for evaluation the Marketing Authorization Application (MAA) for oral iloperidone tablets.
It is estimated that schizophrenia affects approximately 5 million Europeans or 1.0% of the
European Union (EU) population.
On July 11, 2011, Vanda announced it had entered into an exclusive license agreement with Probiomed
for the commercialization of Fanapt in Mexico. Under the terms of the agreement,
Probiomed will seek regulatory approval for Fanapt in Mexico. With $9.3 billion in
annual sales, Mexico is the second largest pharmaceutical market in Latin America and the 14th
largest pharmaceutical market in the world.
On August 1, 2011, Vanda announced it had entered into an exclusive license agreement with
Biotoscana for the commercialization of Fanapt in Argentina. On July, 28, 2011, Biotoscana
filed for market approval of Fanapt with the Administraci n Nacional de
Medicamentos, Alimentos y Tecnolog a M dica (ANMAT). With over $5 billion in annual sales,
Argentina is the fourth largest pharmaceutical market in Latin America.
Enrollment continues in the first pivotal efficacy study of tasimelteon for the treatment of
N24HSWD in blind individuals with no light perception. An investigator meeting was held in May
2011 for the new German investigative sites.
Preparation for a tasimelteon Phase IIb/III study in major depression is ongoing and it is our
expectation that the study will begin enrollment in the second half of 2011.
Vanda has scheduled a conference call for today, Thursday, August 4, 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 CFO, will discuss the second quarter 2011 results and other corporate activities.
Investors can call 1-866-314-5232 (domestic) and 1-617-213-8052 (international) prior to the 10:00
AM start time and ask for the Vanda Pharmaceuticals conference call hosted by Dr. Polymeropoulos
(participant passcode 16117516). A replay of the call will be available beginning Thursday, August
4, 2011 at 1:00 PM ET and will be accessible until Thursday, August 11, 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 57140859.
The conference call will be broadcast simultaneously on Vanda s 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 Vanda s website for a period of 30
days, through September 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 company s forward-looking statements include, among others: the extent and
effectiveness of the development, sales and marketing and distribution support Fanapt receives;
Vanda s ability to successfully commercialize Fanapt outside of the U.S. and Canada; delays in the
completion of Vanda s clinical trials; a failure of Vanda s products, product candidates or
partnered products to be demonstrably safe and effective; Vanda s 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 Vanda s products, product candidates or partnered
products in the marketplace, or a failure to become or remain profitable; Vanda s expectations
regarding trends with respect to its costs and expenses; Vanda s inability to obtain the capital
necessary to fund additional research and development activities; Vanda s failure to identify or
obtain rights to new products or product candidates; Vanda s failure to develop or obtain sales,
marketing and distribution resources and expertise or to otherwise manage its growth; limitations
on Vanda s ability to utilize some or all of its prior net operating losses and research and
development credits; 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 or product candidates under its license and sublicense agreements