Rigel Pharmaceuticals, Inc.

Greetings, and welcome to Rigel Pharmaceutical's financial conference call for the third quarter of 2023. At this time, all participants are in listen-only mode. The brief question and answer session will follow the formal presentation. If anyone today should require operator assistance during the conference, please press star zero from your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce our first speaker, Ray Furey. Rigel's Executive Vice President, General Counsel, and Corporate Secretary. Thank you, Mr. Fury. You may begin.

Welcome to our third quarter 2023 financial results business update conference call. The financial press release for the third quarter 2023 was issued a short while ago and can be viewed along with the slides for this presentation in the news and events section of our investor relations site on Rigel.com. As a reminder, during today's call, we may make forward-looking statements regarding our financial outlook and our plans and timing for regulatory and product development. These statements are subject to risks and uncertainties that may cause actual results to differ from those forecasted. A description of these risks can be found in our most recent annual report on Form 10-K for the year ended December 31st, 2022, and subsequent filings with the SEC, including our third quarter quarterly report on Form 10Q on file with the SEC. Any forward-looking statements are made only as of today's date, and we undertake no obligation to update these forward-looking statements to reflect subsequent events or circumstances. At this time, I would like to turn the call over to our President and Chief Executive Officer, Raul Rodriguez. Raul.

Thank you, Ray, and thank you, everyone, for joining today. Also with me today are Dave Santos, our Chief Commercial Officer, and Dean Shornum, our Chief Financial Officer. Let me begin on slide four. The third quarter was an important one for Rigel, one in which we made meaningful progress on growing the sales of our commercial products. This growth, coupled with tight financial discipline, allowed us to make important progress on our plans to reach financial break-even. We'll review the components of this during today's presentation. Regarding product sales, in the third quarter, we delivered a robust performance for our first approved product, Tavalise, for adult chronic ITP. Demand bottles shipped to patients and clinics reached a new quarterly record since launch. We grew net product sales by 15% quarter over quarter and 27% year over year. We are pleased with the continued momentum that our team is generating for Tavalise. For our second approved product, Reslydia, for adult relapse or refractory mutant IDH1 positive AML, we saw continued growth in bottles shipped to patients and clinics in the third quarter as we increased awareness of the product through our new institutional sales team. Just last week, we announced several poster presentations at the ASH meeting, which include new supportive data on Reslydia in various mutant IDH1 relapse or refractory AML patient populations. We look forward to engaging with the medical community at the ASH meeting to further raise awareness and highlight our products. Shifting to our development programs, here we're extremely focused and cost-efficient in our efforts. With R289, our IRAC 1 and 4 inhibitor in phase 1B for lower risk MDS, we are currently enrolling the third cohort and we expect initial results from all dose groups in mid 2024. We continue to evaluate clinical development options to expand our pipeline, particularly with olosutinib. We believe olosutinib has potential in a variety of settings in AML and in additional cancers where mutant IDH1 plays a role. We plan to be modest. We plan that modest, focused investments in our hemonc opportunities will be funded from our own internal business. I will touch on this more later in the presentation. In addition, we continue to assess in-license opportunities for late-stage hematology oncology products to broaden our pipeline that are synergistic and further leverage our in-house capabilities. In summary, this past quarter was important, as we made good progress on our plan to reach financial break-even. This is based on strong growth from our commercial business and financial expense discipline. Now, let us review this in more detail, starting with Dave on our commercial business. Dave? Thank you, Ro.