Tomahawk, WI 03/18/2014 (Basicsmedia) – The U.S. Food and Drug Administration approved a drug from Vanda Pharmaceuticals Inc. (NASDAQ:VNDA) to treat non-24-hour sleep-wake disorder (or simply ‘non-24’) in January. Hetlioz (tasimelteon) is the first ever drug approved to treat non-24. Non-24 is a chronic circadian rhythm disorder that affects some people who are totally congenitally blind or have lost their vision entirely. Hetlioz is likely to become commercially available in the second quarter of 2014.

Full Year And Quarterly Results

FY2013 total revenues were $33.9 million, compared to $32.7 million for FY2012. The company received royalties of $7.1 million for Fanapt in FY2013 from Novartis AG (ADR) (NYSE:NVS). Novartis has made an upfront payment of $200.0 million for U.S. and Canadian rights to Fanapt.

Operating expenses for FY2013 were $54.3 million, compared to $61.0 million for FY2012. R&D expenses for FY2013 were $28.2 million. R&D expenses were significantly lower compared to the FY2012 level of $45.4 million primarily on account of the completion of the clinical trials and efficacy studies related to Hetlioz.

FY2013 net loss was $20.3 million, compared to $27.7 million for FY2012.

4Q2013 total revenues were $8.8 million, compared to $7.9 million for 4Q2012. Royalties from Novartis for Fanapt were $2.0 million in 4Q2013 as compared to $1.2 million in 4Q2012. Total operating expenses for 4Q2013 were $16.5 million compared to $14.3 million for 4Q2012. Net loss for 4Q2013 was $7.6 million, compared to $6.4 million for 4Q2012.

The launch of Hetlioz in the U.S. is imminent and the process for launching it in Europe too has begun. With a unique drug for a niche market, the company will see revenue growth in 2014 and beyond from Hetlioz sales. Patient investors can hold on to the stock of Vanda Pharmaceuticals Inc. (NASDAQ:VNDA) on account of definite future growth prospects. But for more impatient investors, there are other options in the biopharma sector with strong ‘Buy’ recommendations.

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