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5/7/2024
Greetings and welcome to Rigel Pharmaceuticals' financial conference call for the first quarter of 2024. At this time, all participants are in listen-only mode. A brief question and answer session will follow the formal presentation. If anyone today should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce our first speaker, Ray Fury, Rigel's Executive Vice President, General Counsel, and Corporate Secretary. Thank you, Mr. Furrier. You may now begin.
Thank you. Welcome to our first quarter 2024 financial results and business update conference call. The financial press release for the first quarter 2024 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 writer.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 uncertainty 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 31, 2023, and subsequent filings with the SEC, including our Quarter 1 reporting report on Point 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. With me today are Dave Santos, our Chief Commercial Officer, and Dean Shornow, our Chief Financial Officer. Additionally, I'd like to introduce Lisa Royker, our new chief medical officer. Lisa joined us in March and brings over 20 years of clinical development, regulatory, and medical affairs experience to Rangel. We are thrilled to have her on the team. Now beginning on slide four, we continue to grow our hematology and oncology business in the first quarter of the year, positioning us well for the remainder of 2024 and beyond. We started 2024 with strong commercial demand for our two marketed products, Tavalisan ITP and ResLydia in mutant IDH1 relapse or refractory AML, with demand bottles for each of these two products reaching a new quarterly high since their launch. This is particularly impressive since the first quarter of the year is typically one where our industry faces headwinds due to insurance co-pays and resets and the medical donut hole. The decline in net product sales from the prior quarter is primarily due to a decrease in Tavalis bottles remaining in our distribution channel or inventory. In addition, we are also expanding our commercial product portfolio with the recent acquisition of Gavretto, an FDA-approved therapy for the treatment of red fusion positive metastatic non-small cell lung cancer and advanced or metastatic thyroid cancer. Gabretto offers a valuable targeted treatment option for non-small cell lung cancer patients with red fusion positive disease. Gabretto will provide us with top line growth as well as leverage our existing commercial and medical affairs infrastructure. We remain on track to complete the transition of this asset in July of this year. In parallel, we're advancing our development programs, including the evaluation of ResLydia in a broad range of IDH1 mutant cancers with our strategic partners, MD Anderson Cancer Center and Connect. These alliances greatly enhance our ability to further evaluate ResLydia's potential in a cost and time-efficient manner. As we grow our commercial product portfolio and prioritize prudent clinical development, We are well positioned to advance our business and work towards financial breakeven. Before I turn the call over to Dave, I'll provide a summary of our previously announced acquisition of U.S. rights to Gabretto. On slide five, we are working diligently to ensure a smooth transition of Gabretto into our commercial product portfolio, which we expect to complete in July. There are strong synergies between this product and our existing portfolio, infrastructure, and expertise. We believe we have the right people and systems in place to bring this product to physicians and their patients. Gabretto is a once-daily oral RET inhibitor with an established foothold in the U.S. market, having generated $28 million in U.S. net product sales in 2023. Further, with patents that have issued or are expected to issue with statutory expiration dates between 2036 and 2041, we are well positioned to make Gavaretto available for years to come. In exchange for U.S. rights to Gavaretto, we will pay our partner, Blueprint, a purchase price of $15 million, $10 million of which is payable upon first commercial sale and $5 million of which is payable upon the first anniversary of the closing date. The deal also includes potential future regulatory and commercial milestone payments to Blueprint, as well as tiered royalties on net sales of Fabredo. We believe this puts Rigel in a favorable position to begin capturing value from this program in the near term. Now, I will turn the call over to Dave to provide updates on our commercial product portfolio. Dave?
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