“2014 was a transformational year for Vanda with the Hetlioz launch in the US for the treatment of Non-24-Hour Sleep-Wake Disorder. We are impressed with the continued growth of HETLIOZ and are fortunate to be able to offer this important treatment option for patients,” says Vanda Pharmaceuticals’ president and CEO Mihael H. Polymeropoulos, MD, in a release about the company’s fourth quarter 2014 and full year 2014 financial results. “The return of the US and Canadian commercial rights to Fanapt brings an immediately accretive product to Vanda further strengthening our U.S. commercial portfolio.”

Key highlights for Hetlioz (tasimelteon) include:

  • Hetlioz net product sales in the United States grew to $6.0 million in the fourth quarter of 2014, a 15% increase, compared to $5.2 million in the third quarter of 2014. Hetlioz net product sales were $12.8 million for the full year 2014.
  • Since the US commercial launch of Hetlioz in April 2014, over 760 new patient prescriptions have been written including over 220 in the fourth quarter of 2014. As of December 31, 2014, over 470 patients had initiated Hetlioz treatment and over 330 patients were on active treatment reflecting a cumulative persistence rate of approximately 70%.
  • The Hetlioz Marketing Authorization Application in the European Union (EU) is under review with a regulatory decision expected in the third quarter of 2015.
  • Tasimelteon life cycle management activities are ongoing and include a Smith-Magenis syndrome observational study with results expected in the first half of 2015 and preparations for a clinical development program for pediatric Non-24.
  • Hetlioz exclusivity in the United States is protected by orphan exclusivity and two patents listed in the FDA Orange Book (orphan exclusivity expiry in 2021; Patent No. 5,856,529 expiry expected in 2022 and Patent No. 8,785,492 expiry in 2033).

Vanda total revenues for the fourth quarter of 2014 were $15.4 million, compared to $8.8 million for the fourth quarter of 2013. Vanda total revenues for the full year 2014 were $50.2 million, compared to $33.9 million for 2013.

Selling, general, and administrative expenses were $17.3 million in the fourth quarter of 2014, compared to $9.9 million in the fourth quarter of 2013. Selling, general, and administrative expenses were $84.6 million in the full year 2014, compared to $25.1 million in 2013. The increases in selling, general, and administrative expenses in fourth quarter and full year 2014 were the result of the US commercial launch support for Hetlioz.

Research and development expenses were $4.8 million in the fourth quarter of 2014, compared to $6.3 million in the fourth quarter of 2013. Research and development expenses were $19.2 million in the full year 2014, compared to $28.5 million in 2013.

Vanda recorded a $77.6 million gain related to the Novartis arbitration settlement in the fourth quarter of 2014.

Vanda net income was $69.7 million for the fourth quarter of 2014, compared to a net loss of $7.7 million for the fourth quarter of 2013. Diluted net income per share for the fourth quarter of 2014 was $1.77, compared to a net loss per share of $0.23 for the fourth quarter of 2013. Vanda net income was $20.2 million for the full year 2014, compared to a net loss of $21.1 million for 2013. Diluted net income per share for the full year 2014 was $0.55, compared to a net loss per share of $0.69 for 2013.

In October 2014, Vanda completed a public common stock offering that resulted in $62.3 million in net proceeds. In December 2014, Vanda sold $25.0 million of common stock to Novartis as part of the arbitration settlement. Cash, cash equivalents, and marketable securities were $129.8 million as of December 31, 2014.