Release Date: August 06, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Rigel Pharmaceuticals Inc (RIGL, Financial) reported a 40% increase in net product sales, reaching $33.5 million in Q2 2024 compared to $23.9 million in Q2 2023.
- The addition of GAVRETO to the product portfolio has been successful, contributing nearly $2 million in early sales.
- Tavalisse achieved its seventh consecutive quarterly record high with $26.4 million in net product sales, a 24% increase from Q1 2024.
- REZLIDHIA sales doubled compared to the same period last year, reaching $5.2 million in Q2 2024.
- The company is nearing financial breakeven, which will allow for reinvestment in business and pipeline programs.
Negative Points
- Despite the growth, Rigel Pharmaceuticals Inc (RIGL) still faces significant competition in the market, particularly with new approvals like baricitinib for glioma.
- The company has not yet provided revenue guidance for the coming years, which may create uncertainty for investors.
- There are ongoing risks and uncertainties related to regulatory and product development that could impact future results.
- The cost of product sales increased due to higher amortization of intangibles and royalties, as well as increased personnel-related costs.
- The company is still in the early stages of some clinical trials, such as the Phase 1b trial for R289, which means it will take time to see results and potential market impact.
Q & A Highlights
Q: Could you expand a bit on the reasons for the new IRAK1/4 dose escalation cohorts?
A: The focus is to determine the optimal dose for phase two expansion, evaluating safety, PK, and preliminary efficacy. We want to thoroughly explore all potential combinations, including once daily and twice daily dosing. Data will be available by the end of the year. (Lisa Rojkjaer, EVP & Chief Medical Officer)
Q: What is the goal for the MD Anderson collaboration study with olutasidenib, venetoclax, and azacytidine?
A: We are encouraged by preliminary data and aim to evaluate olutasidenib in its own right, particularly with an oral decitabine regimen. This could lead to a novel oral triplet therapy, beneficial for elderly patients ineligible for intensive therapies. (Lisa Rojkjaer, EVP & Chief Medical Officer)
Q: Are you planning to provide revenue guidance for the company in the coming years?
A: The business is solidifying, and new product launches make forecasting challenging. We evaluate providing guidance regularly and may do so in the future. Reaching financial breakeven is a significant achievement, allowing us to generate cash for additional clinical trials. (Raul Rodriguez, President & Chief Executive Officer)
Q: What are the key drivers for new patient starts for TAVALISSE?
A: Growth is driven by both new prescribers and increased depth within existing prescribers. We are seeing more earlier line patients, and the continuous flow of new patient starts and strong carryover from refills contribute to sales growth. (Dave Santos, EVP & Chief Commercial Officer)
Q: How will you balance financial discipline with potential new indications or strategies?
A: We aim to continue deals similar to those with Forma and Blueprint, focusing on hem onc products that leverage our current capabilities and are near-term market-ready. This approach provides significant growth opportunities and financial impact. (Raul Rodriguez, President & Chief Executive Officer)
Q: What is the impact of the FDA approval of baricitinib for glioma on your study plans for olutasidenib?
A: Baricitinib's approval is positive, proving IDH's role in gliomas. Our study with CONNECT positions olutasidenib in the maintenance setting post-radiotherapy, and we are exploring other potential settings. Differences between the molecules will be highlighted as we progress. (Lisa Rojkjaer, EVP & Chief Medical Officer; Dave Santos, EVP & Chief Commercial Officer)
Q: How do you plan to manage a more complex product portfolio?
A: Our team has matured and solidified its ability to execute on different priorities. We have successfully transitioned to managing multiple products and are confident in handling a more complex portfolio. (Dave Santos, EVP & Chief Commercial Officer)
Q: What are your expectations for the third quarter gross to net adjustments for TAVALISSE, REZLIDHIA, and GAVRETO?
A: We expect gross to net adjustments to be approximately 35% for TAVALISSE, 23% for REZLIDHIA, and 26% for GAVRETO. We anticipate continued strength in year-over-year net product sales growth. (Dean Schorno, EVP & Chief Financial Officer)
Q: How are you progressing with the R289 IRAK1/4 inhibitor program?
A: Enrollment in the fourth dose level of 250 mg twice daily is nearing completion. We anticipate presenting preliminary data from the first part of the trial later this year. (Lisa Rojkjaer, EVP & Chief Medical Officer)
Q: What are the strategic goals for your development collaborations with MD Anderson and CONNECT?
A: We aim to advance olutasidenib into new clinical indications and evaluate it in combination with other agents. Our goal is to position ourselves for subsequent registrational trials and provide new treatment options for underserved patient populations. (Lisa Rojkjaer, EVP & Chief Medical Officer)
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
