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Vanda Pharmaceuticals Reports Fourth Quarter 2013 and Full Year 2013 Results
WASHINGTON February 13, 2014 Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ:VNDA), a biopharmaceutical company focused on the development and commercialization of products for the treatment of central nervous system disorders, today announced financial and operational results for the fourth quarter and full year ended December 31, 2013.
The recent FDA approval of HETLIOZ marks an important advancement in the treatment of Non-24, said Mihael H. Polymeropoulos, M.D., Vandas President and Chief Executive Officer. We are excited by the opportunity to help Non-24 patients and are committed to providing much needed support and facilitating access to this new therapeutic option.
|||On January 31, 2014, Vanda announced that the U.S. Food and Drug Administration (FDA) approved HETLIOZ (tasimelteon) 20mg capsules for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24). Non-24 affects the majority of totally blind individuals and it is estimated that approximately 80,000 Americans have the disorder.|
|||HETLIOZ is the first and only FDA approved medication for Non-24. Vanda expects HETLIOZ to be available to patients in the second quarter of 2014.|
|||Vanda is preparing to file a Marketing Authorization Application (MAA) for tasimelteon for the treatment of Non-24 with the European Medicines Agency (EMA) during 2014.|
FULL YEAR 2013 REPORTED RESULTS
Total revenues for the full year 2013 were $33.9 million, compared to $32.7 million for 2012. Full year 2013 revenues included $7.1 million in Fanapt® royalties received from Novartis as compared to royalties of $5.9 million for the prior year. Both 2013 and 2012 revenues include $26.8 million recognized from the $200.0 million upfront payment previously received from Novartis for Fanapt® U.S. and Canadian rights.
Total operating expenses for 2013 were $54.3 million, compared to $61.0 million for 2012. Full year 2013 research and development expenses of $28.2 million included $3.5 million in milestone payments associated with the FDA acceptance of the HETLIOZ New Drug Application. The primary driver of the lower research and development expenses in 2013 as compared to $45.4 million in 2012 was the completion of the HETLIOZ Non-24 and Major Depressive Disorder efficacy studies. General and administrative expenses of $24.6 million for 2013 were $10.7 million higher than for 2012 and reflect the increased commercial activity in preparation for the launch of HETLIOZin the United States.
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The following information was filed by Vanda Pharmaceuticals Inc. (VNDA) on Thursday, February 13, 2014 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-K Annual Report statement of earnings and operation as management may choose to highlight particular information in the press release.
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