Vanda Pharmaceuticals, Inc. (NASDAQ:VNDA) Q4 2018 Earnings Conference Call Transcript

Feb 13, 2019 • 04:30 pm ET

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Vanda Pharmaceuticals, Inc. (NASDAQ:VNDA) Q4 2018 Earnings Conference Call Transcript

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Presentation
Operator
Operator

Good day, ladies and gentlemen, and welcome to the Vanda Pharmaceuticals Fourth Quarter 2018 Earnings Conference Call. At this time, all participants are in a listen-only mode. (Operator Instructions) Later, we will conduct a question-and-answer session and instructions will follow at that time. As a reminder, today's conference is being recorded.

I'd now like to introduce your host for today's conference, Mr. Jim Kelly, Executive Vice President and Chief Financial Officer. Sir, please go ahead.

Executive
James Patrick Kelly

All right, thank you, Liz. Good afternoon, and thank you for joining us to discuss Vanda Pharmaceuticals fourth quarter and full-year 2018 performance. Our fourth quarter and full-year 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 will be providing live and archived versions of this conference call on our website. Joining me on today's call is Dr. Mihael Polymeropoulos, our President and CEO. Following my introductory remarks, Mihael 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 Operation sections of our Annual Report on Form 10-K for the fiscal year ended December 31, 2017, and quarterly report on Form 10-Q for the quarter ended September 30, 2018, which are available on the SEC's EDGAR system and on our website. Additional factors may be set forth in those sections of our Annual Report on Form 10-K for the fiscal year ended December 31, 2018 to be filed with the SEC in the first quarter of 2019.

We encourage all investors to read these reports and our other SEC filings. The information we provide on this call is provided only as 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'd now like to turn the call over to our CEO, Dr. Mihael Polymeropoulos.

Executive
Mihael Polymeropoulos

Thank you, Jim. Good afternoon. 2018 has been a year of great accomplishments and growth for Vanda in both commercial and research and development. Before I review our achievements and share our plans for 2019, I would like to address the importance of last week's announcement and how it makes our Company stronger for our patients and shareholders.

Last week, we announced that Vanda filed a complaint against the Food and Drug Administration asking the court to set aside a partial clinical hold affecting certain proposed studies of 20%. The FDA imposed this partial clinical hold on two proposed studies. The first was a proposed