Supernus Pharmaceuticals, Inc. (NASDAQ:SUPN) Q3 2019 Earnings Conference Call - Final Transcript
Nov 06, 2019 • 09:00 am ET
Good morning, ladies and gentlemen, and welcome to Supernus Pharmaceuticals Third Quarter 2019 Financial Results Conference Call. [Operator Instructions]
I would now like to turn the conference over to Peter Vozzo of Westwicke, Investor Relations representative for Supernus Pharmaceuticals. Sir, you may begin.
Thank you, Tawanda. Good morning, everyone, and thank you for joining us today for Supernus Pharmaceuticals third quarter 2019 financial results conference call. Yesterday, after the close of the market, the Company issued a press release announcing these results. On the call with me today are Supernus' Chief Executive Officer, Jack Khattar; and Chief Financial Officer, Greg Patrick. Today's call is being made available via the Investor Relations section of the Company's website at ir.supernus.com. Following remarks by management, we will open the call to questions.
During the course of this call, management may make certain forward-looking statements regarding future events and the Company's future performance. These forward-looking statements reflect Supernus' current perspective on existing trends and information and can be identified by such words as expect, plan, will, may, anticipate, believe, should, intend and other words of similar meaning. Any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, including those noted in the Risk Factors section of the Company's 2018 Annual Report on Form 10-K. Actual results may differ materially from those projected in these forward-looking statements.
For the benefit of those of you who may be listening to the replay, this call is being held and recorded on November 6th, 2019 at approximately 9:00 a.m. Eastern Time. Since then, the Company may have made additional announcements related to the topics discussed. Please reference the Company's most recent press releases and current filings with the SEC. Supernus declines any obligation to update these forward-looking statements except as required by applicable securities laws.
I will now turn the call over to Jack.
Jack A. Khattar
Thank you, Peter. Good morning, everyone, and thanks for taking the time to join us as we discuss our 2019 third quarter results. In our press release yesterday, we announced the results of the P301 first Phase III study for SPN-810 for the treatment of impulsive aggression in ADHD patients 6 to 11 years old. The study was a randomized, double-blind, placebo controlled, multicenter, parallel group clinical trial in patients diagnosed with ADHD.
Patients receiving SPN-810 36 milligram showed a median percent reduction of 58.6% in the average weekly frequency of impulsive aggression episodes from the baseline that was not statistically significant with a p-value of 0.092 compared to placebo. These results are based on the combined analysis of the data from stages one and two in the study. In stage one, which was the stage right before the interim analysis, the median percent reduction was 60%, which was statistically significant with a p-value of 0.029 compared to placebo. However, post the interim analysis in stage two of the study, the increase in variability in the 36 milligram treatment arm seems to have adversely impacted the results in the combined