Vanda Pharmaceuticals, Inc. (NASDAQ:VNDA) Q3 2018 Earnings Conference Call Transcript

Nov 07, 2018 • 04:30 pm ET

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Vanda Pharmaceuticals, Inc. (NASDAQ:VNDA) Q3 2018 Earnings Conference Call Transcript

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Presentation
Operator
Operator

Hello, and welcome to the Third Quarter 2018 Vanda Pharmaceuticals Incorporated Earnings Teleconference. My name is Michelle, and I will be your operator for today's call. At this time all participants are in a listen-only mode. Later, we will conduct a question-and-answer session. (Operator Instructions) Please note that today's conference is being recorded.

I will now turn the call over to Mr. Jim Kelly, Executive Vice President and Chief Financial Officer. Sir, you may begin.

Executive
James Patrick Kelly

Great. Thank you, Michelle. Good afternoon, and thank you for joining us to discuss Vanda Pharmaceuticals' third quarter 2018 performance. Our third quarter 2018 results were released this afternoon and are available on the SEC's EDGAR system and on our website, www.vandapharma.com. In addition, we are providing live and archived versions of this conference call on our website.

Joining me on today's call is Dr. Mihaeles Polymeropoulos, our President and CEO. Following my introductory remarks, Mihaeles will update you on our ongoing activities, then I will comment on our financial results before opening the lines for your questions.

Before we proceed, I'd like to remind everyone that various statements that we make on this call will be forward-looking statements within the meaning of federal securities laws. Our forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. These risks are described in the Risk Factors and Management's Discussion and Analysis of Financial Condition and Results of Operations sections of our annual report on Form 10-K for the fiscal year ended December 31, 2017, and on quarterly report on Form 10-Q for the quarter ended June 30, 2018, which are available on the SEC's EDGAR system and on our website. We encourage all investors to read these reports and our other SEC filings. The information we provide on this call is provided only as of today, and we undertake no obligation to update or revise publicly any forward-looking statements we may make on this call on account of new information, future events or otherwise, except as required by law.

With that said, I would like to now turn the call over to our CEO, Dr. Mihaeles Polymeropoulos.

Executive
Mihael H. Polymeropoulos

Thank you, Jim. Good afternoon. This quarter marks more than four years since the launch of HETLIOZ for Non-24 hours sleep-wake disorder. At this time, we have identified more than 20,000 patients with Non-24, one of the rarest circadian rhythm disorders. Our innovative approach to commercialize HETLIOZ in Non-24 continues to drive significant revenue growth, achieving a 34% year-over-year growth this quarter. We continued building on our success and have now submitted a supplemental New Drug Application to the FDA in order to market tasimelteon for Jet Lag Disorder.

In Smith-Magenis Syndrome, SMS, we have completed enrollment of the study and plan to have top line results by end of the year. At the same time, we are now initiating investigations into delayed sleep phase disorder, one of the most common circadian rhythm sleep disorders affecting about 0.5% of the population or more than