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Receptos, Inc. (RCPT)
Q2 2014 Results Earnings Conference Call
August 12, 2014, 08:00 AM ET
Faheem Hasnain - President and CEO
Graham Cooper - CFO
Sheila Gujrathi - Chief Medical Officer
Joseph Schwartz - Leerink Partners
Jim Birchenough - BMO Capital Markets
Previous Statements by RCPT
» Receptos' (RCPT) CEO Faheem Hasnain on Q1 2014 Results - Earnings Call Transcript
» Receptos' CEO Discusses Q4 2013 Results - Earnings Call Transcript
» Receptos, Inc.'s CEO Discusses Q3 2013 Results - Earnings Call Transcript
» Receptos' CEO Discusses Q2 2013 Results - Earnings Call Transcript
I would now like to introduce your host for today's conference, Faheem Hasnain, Chief Executive Officer. Please go ahead.
Good morning, thank you for joining us for the Receptos second quarter 2014 earnings call. With me today are Graham Cooper, our Chief Financial Officer; and Sheila Gujrathi, our Chief Medical Officer. Today's call is also being webcast live on our website and will be available for replay until August 26th.
Before we begin I'll ask Graham to handle the forward-looking statement disclaimer. I’ll then provide a business update and Sheila will review our clinical development programs and then Graham will walk you through our financial results. I will summarize by outlining the opportunity for Receptos and our strategy to maximize the value of our assets. And after that of course we'll be happy to take any questions that you may have. Graham?
Thanks, Faheem. Please note that except for statements of historical facts, the statements in this conference call are forward-looking statements under the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements involve risks and uncertainties that can cause actual results to differ materially from those in such forward-looking statements. Please see the forward-looking statement disclaimer on the company's earnings press release issued today, as well as the risk factors in the company's SEC filings.
Undue reliance should not be placed on forward-looking statements which speak only as of the date they are made and the facts and assumptions underlying these forward-looking statements may change. Except as required by law Receptos disclaims any obligation to update these forward-looking statements to reflect future information, events or circumstances.
Thanks Graham. The second quarter of 2014 was a transformative quarter for Receptos. We reported positive results from the Phase 2 portion of the RADIANCE trial in relapsing multiple sclerosis in June setting the stage for an extremely successful equity offering and giving us even greater confidence as we drive forward with our Phase 3 programs.
Furthermore, I am pleased to report today two new key pieces of information. First, with regard to the Phase 3 trial of RPC1063 in ulcerative colitis, we have completed enrollment in that trail. As you will recall the primary endpoint to the trail is the induction of clinical remission after eight weeks of therapy. So we are clearly on track to announce the results of that trial in the fourth quarter consistent with current guidance. The trail was designed to enroll 180 patients and based on strong interest among clinicians and patients we ended up over enrolling the trail by about 10%.
Second, we were recently notified that we have been granted a late breaking oral platform presentation at MS Boston 2014 which is a joint ACTRIMS/ECTRIMS meetings this year. We understand that there are over 1500 regular abstracts and approximately 150 late breaking abstract submitted for presentation. So we were very gratified to find that we had made the cut in this exclusive group. The presentation is scheduled for Saturday, September 13.
In addition to the top line data that we have disclosed already we plan to go into greater detail for the primary and secondary efficacy endpoints as well as safety and tolerability data. Also as a reminder we mentioned in a recent press release that Receptos announced the additions of Mary Szela and Richard Heyman to our Board of Directors. Mary is the CEO and Chairperson of Melinta Therapeutics and was previously Senior Vice President of Global Strategic Marketing at Abbott Laboratories. Rich Heyman was recently Chief Executive Officer at two private companies, Seragon Pharmaceuticals, which recently got acquired by Roche for up to $1.7 billion in transaction value. We are very pleased to have both Mary and Rich join our Board.
I will now hand the call over to Sheila to review the key aspects of our Phase II data and the implications for our differentiation platform. She will also provide an update on the Phase III program in relapsing MS as well as the [inaudible] and GLP-1 programs.
Thank you Faheem. As noted the top line Phase II data has already been disclosed I won’t plan to go into great detail but I do want to review the data particularly as it pertains to differentiation profile that continues to emerge for RPC1063. As Faheem mentioned the data will be presented in detail during our Oral Podium presentation at the MS Boston meeting on September 13.
First, with regard to our primary efficacy endpoint, we saw a reduction in MRI base lesion count at 86% for both dose group compared to placebo. This result was highly significant again with a p value well below 0.0001. The efficacy result is inline with the efficacy that had been seen with other S1P receptor modulators in Phase II and Phase III trials. We also showed improvements for patients in RPC1063 in the MRI base key secondary endpoints with p values over less than 0.0001. And on annualized relapse rate another pre-specified key secondary endpoint we showed favorable trends for the RPC1063 treatment groups over placebo, notwithstanding the fact that we did not power the study to detect differences from placebo on ARR with statistical significance and recognizing that there are low rates of relapses in a 24 week trial. We’ll plan to explain this more fully when we disclose the detailed results next month.