Vanda Pharmaceuticals, Inc. (VNDA)

[surf1944]

Vanda Pharmaceuticals Reports Third Quarter 2009 Results
Press Release
Source: Vanda Pharmaceuticals Inc.
On 7:00 am EST, Monday November 2, 2009

Companies:Vanda Pharmaceuticals, Inc.
ROCKVILLE, Md., Nov. 2 /PRNewswire-FirstCall/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA - News), 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(TM) (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, Vanda's 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(TM). 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.

Pursuant to the agreement, Novartis will have exclusive commercialization rights to all formulations of Fanapt(TM) 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(TM).

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(TM) 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(TM) 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(TM) or any future royalty payments with respect to sales of Fanapt(TM) in the U.S. and Canada.

Vanda retains exclusive rights to Fanapt(TM) outside the U.S. and Canada and Vanda will have exclusive rights to use any of Novartis' data for Fanapt(TM) for developing and commercializing Fanapt(TM) outside the U.S. and Canada. At Novartis' option, the parties will enter into good faith discussions relating to the co-commercialization of Fanapt(TM) outside of the U.S. and Canada or, alternatively, Novartis will receive a royalty on net sales of Fanapt(TM) 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


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(TM) 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.


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.


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-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.


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.


Vanda's 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.


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.


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(TM) 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(TM) 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(TM). In addition, the Company will also evaluate the regulatory path and commercial opportunity for Fanapt(TM) 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 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 December 2, 2009.