Vanda Pharmaceuticals Inc., 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 second quarter ended June 30, 2014.
“We are encouraged by the early positive reception of HETLIOZ by patients, physicians and payors. We look forward to more patients benefiting from HETLIOZ in the coming months and years,” said Mihael Polymeropoulos MD, President and CEO of Vanda Pharmaceuticals.
Key Highlights:
- As of August 6, 2014, over 420 new patient prescriptions have been written for HETLIOZ®(tasimelteon) in the U.S.
- In June 2014, Vanda announced that the European Medicines Agency (EMA) accepted for evaluation the Marketing Authorization Application for oral HETLIOZ® capsules for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24).
- In July 2014, the U.S. Patent and Trademark Office (USPTO) issued a new method of use patent for HETLIOZ® in the treatment of Non-24.
SECOND QUARTER 2014 REPORTED RESULTS
Total revenues for the second quarter of 2014 were $10.9 million, compared to $9.1 million for the first quarter of 2014 and $8.3 million for the second quarter of 2013. Net product revenues related to U.S. sales of HETLIOZ® in the second quarter of 2014 were $1.6 million.
Total operating expenses for the second quarter of 2014 were $32.5 million, compared to $35.7 million for the first quarter of 2014 and $11.7 million for the second quarter of 2013. Vanda recorded a net loss of $21.6 million for the second quarter of 2014, compared to a net loss of $26.5 million for the first quarter of 2014 and $3.4 million for the second quarter of 2013.
Cash, cash equivalents and marketable securities (Cash) were $63.6 million as of June 30, 2014.
OPERATIONAL HIGHLIGHTS
As of August 6, 2014, over 420 new patient prescriptions have been written for HETLIOZ® in the U.S. This represents growth of approximately 90% in new prescriptions since the Company’s June 4, 2014 commercial update. HETLIOZ® was launched in the U.S. in April 2014 for the treatment of Non-24, a disorder which affects the majority of totally blind individuals. It is estimated that approximately 80,000 Americans have the disorder.
On July 22, 2014, a new method of use patent was issued by the USPTO for HETLIOZ® in the treatment of Non-24 (patent number 8,785,492). The ‘492 patent is expected to expire in 2033, potentially further extending the exclusivity protection of HETLIOZ®. In the U.S., HETLIOZ® is also covered by a composition of matter patent (patent number 5,856,529), which including a Hatch-Waxman 5-year extension is currently expected to expire in 2022. Both patents, ‘529 and ‘492, are now listed in the FDA’s Orange Book.
In June 2014, the EMA accepted for evaluation Vanda’s Marketing Authorization Application for oral HETLIOZ® capsules for the treatment of Non-24. HETLIOZ® was previously granted orphan drug designation by the European Commission for the treatment of Non-24.
Vanda has initiated development activities for the use of HETLIOZ® in the pediatric population with Non-24, as well as in patients with Smith-Magenis syndrome.
The VLY-686, NK1 antagonist, Phase 2 study in chronic pruritus is ongoing and results are expected in mid-2015.
2014 FINANCIAL GUIDANCE
Total 2014 operating expenses are expected to be between $110.0 and $120.0 million. This includes intangible asset amortization expense of $2.3 million and $6.0 to $8.0 million of non-cash stock based compensation.
Full HETLIOZ® Prescribing Information can be found at: www.hetlioz.com.
CONFERENCE CALL
Vanda has scheduled a conference call for today, Thursday, August 7, 2014, at 10:00 AM ET. During the call, Vanda’s management will discuss the second quarter 2014 financial results and other corporate activities. Investors can call 1-800-708-4540 (domestic) and 1-847-619-6397 (international) and use passcode 37729521. A replay of the call will be available beginning Thursday, August 7, 2014 at 12:30 PM ET and will be accessible until Thursday, August 14, 2014, at 11:59 PM ET. The replay call-in number is 1-888-843-7419 for domestic callers and 1-630-652-3042 for international callers. The access number is 37729521.
The conference call will be broadcast simultaneously on Vanda’s website, 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.
ABOUT VANDA PHARMACEUTICALS INC.:
Vanda Pharmaceuticals Inc. is a biopharmaceutical company focused on the development and commercialization of products for the treatment of central nervous system disorders. For more on Vanda, please visit www.vandapharma.com.
