Dose expansion phase will determine the recommended Phase 2 dose of R289 for patients with transfusion dependent R/R lower-risk MDS , /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL), a commercial stage biotechnology company focused on hematologic disorders and cancer, today announced the first patient has been enrolled in the dose expansion phase of the ongoing Phase 1b study of R289 in patients with relapsed or refractory (R/R) lower-risk myelodysplastic syndrome (MDS). R289 is Rigel's potent a ...

Summary of Rigel Pharmaceuticals (RIGL) 2025 Conference Call Company Overview - Rigel Pharmaceuticals is a hematology and oncology company focused on expanding its product portfolio and profitability [2][4] Commercial Products - **Current Products**: - TAVALISSE: For immune thrombocytopenia (ITP) - Rezlidia: For IDH1-mutant relapsed/refractory acute myeloid leukemia (AML) - Gavreto: For RET fusion-positive non-small cell lung cancer and thyroid cancer [3][4] - **Financial Performance**: - Achieved $102 million in revenue for the first half of 2025, with Q2 showing a 76% growth compared to Q2 2024 [4] - TAVALISSE grew by 52% year-over-year, Rezlidia by 36% [16][17] Market Insights - **TAVALISSE**: - Target market includes approximately 81,000 patients in the U.S. with chronic ITP, with 24,000 patients eligible for treatment beyond the first line [5][6] - Early use of TAVALISSE shows significantly better patient outcomes (80-90% benefit in second and third lines) compared to later lines [8][9] - **Rezlidia**: - Addresses a significant unmet need in AML, with 22,000 new cases annually and a high mortality rate [10] - The product has a 35% response rate and a duration of response of nearly 26 months [11] - **Gavreto**: - Positioned to capture market share from existing treatments, with a recent guideline shift favoring RET fusion inhibitors [14] - Achieved $11.8 million in net sales in Q2, showing strong growth potential [15] Clinical Development - **R289**: A dual IRAK1/4 inhibitor targeting lower-risk myelodysplastic syndromes, with fast track and orphan drug designations from the FDA [20][23] - **Oludacitinib (Rezlidia)**: Ongoing studies in glioma and AML, with collaborations established to enhance research and development [28][31] Financial Position - The company reported a profit of $71 million in the first half of 2025, with a cash position increasing from $77 million to $108 million [36] - Raised revenue guidance for total revenue to $270-$280 million and net product sales to $210-$220 million [36][37] Growth Strategy - Rigel aims to continue growing its commercial products while advancing its development programs, particularly R289 and oludacitinib [39] - The company has maintained a 32% CAGR since 2021 and expects approximately 50% growth in 2025 [38] Partnerships and Collaborations - Rigel has established partnerships for international commercialization of its products, enhancing revenue through royalties and product sales [17][18] Conclusion - Rigel Pharmaceuticals is positioned for significant growth with a strong product pipeline, effective commercialization strategies, and a focus on addressing unmet medical needs in hematology and oncology [39]

Financial Data and Key Metrics Changes - The company achieved net product sales of over $58 million, representing a 76% year-over-year increase, marking the best quarter ever [4][31] - Total revenue for the second quarter was $101.7 million, which included $42.7 million in contract revenues from collaborations [4][31] - The company reported net income of $59.6 million for the second quarter, compared to a net loss of $1 million in the same period in 2024 [32] Business Line Data and Key Metrics Changes - TAVALISSE generated $40.1 million in net product sales, a 52% increase compared to 2024 [31] - GAVRETO net product sales reached $11.8 million, up from $1.9 million in 2024, reflecting a 32% sequential growth [31][12] - Reslidia reported $7 million in net product sales, a 36% increase year-over-year [31] Market Data and Key Metrics Changes - The company raised its total revenue guidance for 2025 to between $270 million and $280 million, up from the previous range of $200 million to $210 million [8][33] - The updated guidance reflects anticipated growth of 45% to 52% compared to 2024, exceeding the roughly 30% growth rate delivered over the last few years [8][34] Company Strategy and Development Direction - The company focuses on growing its hematology and oncology business through commercial execution, advancing its pipeline, and maintaining financial discipline [4][6] - The company is committed to pursuing additional in-licensing deals or acquisitions that fit its commercial capabilities and product focus [6][20] - The development pipeline includes R289, a dual IRAK1 and IRAK4 inhibitor, currently in a Phase Ib clinical study for lower risk MDS [16][20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to continue growth, citing improved patient affordability and a strong commercial execution strategy [42][51] - The company anticipates continued positive net income for the full year 2025 while funding existing and new clinical development programs [33][34] Other Important Information - The company recognized $40 million in non-cash revenue related to its collaboration with Lilly, following the decision not to exercise its right to share in future development expenses for okaducerptib [5][30] - The company ended the quarter with a cash balance of over $108 million, compared to $77.3 million as of the same period in 2024 [33] Q&A Session Summary Question: Can you split up the percentages contribution to TAVALISSE's growth? - The growth was driven by a higher percentage of new patient starts, accelerated by improved patient affordability in 2025 [41] Question: Is the 32% CAGR from 2021 to 2024 expected to continue into 2026 and beyond? - The company has not provided guidance beyond this year but expects continued growth and confidence in the product's value [50][51] Question: How does the IRA impact shape guidance going forward? - The company expects continued growth in revenues, projecting double-digit growth at the midpoint of guidance [65]

Core Insights - Rigel Pharmaceuticals reported a strong second quarter in 2025, with a 76% year-over-year increase in net product sales, reaching $58.9 million, and a net income of $59.6 million [2][5][7] Financial Performance - Total revenues for Q2 2025 were $101.7 million, comprising $58.9 million in net product sales and $42.7 million in contract revenues from collaborations [5][10] - Net product sales grew significantly, with TAVALISSE sales at $40.1 million (up 52% from $26.4 million in Q2 2024), GAVRETO at $11.8 million (up from $1.9 million), and REZLIDHIA at $7.0 million (up 36% from $5.2 million) [5][11] - For the first half of 2025, total revenues were $155.0 million, with net product sales of $102.5 million, reflecting a 72% increase compared to the same period in 2024 [8][9] Cost and Expenses - Total costs and expenses for Q2 2025 were $40.6 million, an increase from $36.4 million in Q2 2024, primarily due to higher product sales costs and increased R&D expenses [6][9] - The company reported a net income of $59.6 million for Q2 2025, compared to a net loss of $1.0 million in Q2 2024 [7][12] Business Developments - Rigel completed enrollment in the dose escalation part of its Phase 1b study evaluating R289 in patients with relapsed or refractory lower-risk myelodysplastic syndrome (MDS) [2][11] - The company updated its 2025 financial guidance, projecting total revenue of approximately $270 to $280 million, an increase from the previous estimate of $200 to $210 million [10][13] Collaborations and Agreements - Rigel recognized $40.0 million in non-cash revenue from the release of the remaining cost share liability related to its agreement with Eli Lilly for the development of ocadusertib [3][5] - The company continues to receive milestone and tiered royalty payments on future net sales of ocadusertib as part of its agreement with Lilly [3]

Summary of Rigel's Conference Call Company Overview - **Company**: Rigel Pharmaceuticals - **Industry**: Hematology and Oncology Core Business and Products - Rigel aims to grow its hematology and oncology business with three approved products: - **TAVALISSE** for Immune Thrombocytopenic Purpura (ITP) - **Reslidia** for mutant IDH1 relapsed and refractory Acute Myeloid Leukemia (AML) - **GAVRETO** for RET fusion positive non-small cell lung cancer and thyroid cancer - The company has achieved profitability and plans to maintain it while investing in development opportunities [2][4][60] Financial Performance - Rigel's commercial business has shown a **32% CAGR** since emerging from COVID-19, driven by TAVALISSE and the recent acquisition of GAVRETO [5][6] - Projected net product sales for the current year are between **$185 million and $192 million**, indicating continued growth [5][60] - Q1 sales for TAVALISSE reached **$28 million**, reflecting a **35% year-over-year growth** [6] Product Development and Pipeline - Rigel is developing **R289**, a dual IRAK1 and IRAK4 inhibitor, currently in a Phase 1b study for lower risk MDS, with potential for significant impact on patient care [3][27] - Plans to expand the use of **oludasidenib** beyond mutant IDH1 AML to include glioma trials later this year [4][27] - Rigel is actively seeking in-licensing and acquisition opportunities for late-stage products in hematology and oncology [4][28] Market Dynamics and Competitive Position - TAVALISSE is gaining traction in the treatment of ITP, with a growing patient base and improved treatment paradigms [11][13] - Reslidia shows promising clinical data with a **35% CR/CRH rate** and a durability of response lasting nearly **26 months**, significantly better than previous treatments [17][19] - GAVRETO has captured about **50% market share** in its category, with efforts to convert patients from less effective treatments [21][22] Clinical Trials and Research - Rigel is focusing on the treatment of transfusion-dependent lower risk MDS patients, with a unique mechanism of action targeting inflammatory pathways [31][32] - The company has initiated a Phase II study for oludasidenib in glioma, collaborating with MD Anderson for broader research opportunities [56][58] Financial Outlook - Rigel anticipates total revenue between **$200 million and $210 million** for the year, with a continued focus on financial discipline and cash flow generation [60][61] - The company is committed to funding its development programs through its own cash flow, maintaining a strong financial position [60][62] Conclusion - Rigel is positioned for significant growth in the hematology and oncology sectors, with a robust product portfolio, promising clinical developments, and a strong financial outlook, making it an attractive opportunity for investors [62]

Financial Data and Key Metrics Changes - The company reported total revenue of $53.3 million for Q1 2025, with a year-over-year net product sales growth of 68% [4][40] - Net income for the quarter was $11.4 million, a significant improvement from a net loss of $8.2 million in the same period of 2024 [4][43] - The company anticipates total revenue for 2025 to be in the range of $200 million to $210 million, with net product sales expected to be approximately $185 million to $192 million [6][45] Business Line Data and Key Metrics Changes - TAVALISSE generated net product sales of $28.5 million, a 35% increase year-over-year [40] - GAVRETO, which became available in June 2024, reported net product sales of $9 million, reflecting a 15% year-over-year growth [10][40] - Reslidia achieved net product sales of $6.1 million, marking a 25% increase compared to the prior year [40] Market Data and Key Metrics Changes - The company is expanding access to its products in international markets, with TAVALISSE now available in Japan, Europe, Canada, and Israel [16] - Regulatory approvals for TAVALISSE have been received in Mexico and South Korea, indicating growth opportunities in these regions [16] Company Strategy and Development Direction - The company aims to continue focusing on commercial growth while maintaining financial discipline, with plans to expand its hematology and oncology portfolio through business development [6][19] - The company is committed to advancing its development pipeline, particularly with R289 and elutacitinib, and plans to initiate a Phase II study in recurrent glioma later this year [18][39] - The company has a strategic alliance with MD Anderson Cancer Center to broaden the development of elutacitinib into AML and MDS [36] Management's Comments on Operating Environment and Future Outlook - Management highlighted a strong start to the year despite a challenging business environment for the biotech market, emphasizing the robustness of the corporate strategy [4][6] - The company expects to report positive net income for the full year of 2025 while funding existing and new clinical development programs [45][47] Other Important Information - The company notified Lilly that it will not exercise its right to share in future development expenses for ogadusertib, which may impact future royalty rates [7] - The company reported a sequential decrease in net product sales from Q4 2024 due to inventory drawdowns across distribution channels [41] Q&A Session Summary Question: Clarification on the Target D program and its objectives - Management explained that the Target D program is an umbrella study for patients post-surgery and radiotherapy, while the company's own clinical study will target a different patient population [50][51] Question: Commentary on product sales and first-quarter resets - Management expressed satisfaction with the growth in demand for all three brands, indicating that they were prepared for changes related to the Inflation Reduction Act [60][63] Question: Expectations for R289 and dose escalation - Management confirmed that they are exploring split doses and will seek regulatory feedback on dose escalation data before advancing to the recommended Phase II dose [68][71] Question: Inquiry about ANDA filers and market entry - Management clarified that while there are no current ANDA filers, it is technically possible for second filers to enter the market if they can defeat existing patents [72][74]

Core Viewpoint - Rigel Pharmaceuticals reported strong financial results for Q1 2025, with significant revenue growth and net income, positioning the company for continued investment in its pipeline and commercial growth [2][5][6]. Financial Performance - Total revenues for Q1 2025 were $53.3 million, comprising $43.6 million in net product sales and $9.8 million in contract revenues, marking a 68% increase in net product sales compared to $26.0 million in Q1 2024 [5][9]. - Net income for the quarter was $11.4 million, or $0.64 per share, a turnaround from a net loss of $8.2 million in the same period of 2024 [9][26]. - The company anticipates total revenue for 2025 to be approximately $200 to $210 million, excluding $40 million in non-cash revenue expected in Q2 2025 [6][11]. Product Sales - TAVALISSE net product sales reached $28.5 million, a 35% increase from $21.1 million in Q1 2024 [5][7]. - GAVRETO, which became commercially available in June 2024, generated $9.0 million in net product sales [5][7]. - REZLIDHIA net product sales were $6.1 million, reflecting a 25% increase from $4.9 million in the same period of 2024 [5][7]. Clinical Development - The company is advancing its Phase 1b clinical study of R289 for patients with relapsed or refractory lower-risk myelodysplastic syndromes (MDS) [2][7]. - R289 has received Orphan Drug and Fast Track designations from the FDA for the treatment of MDS [6][7]. Corporate Developments - Rigel appointed Dr. Mark Frohlich to its Board of Directors as an independent director [7]. - The company entered a settlement agreement with Annora Pharma regarding patent litigation related to TAVALISSE, allowing Annora to sell a generic version by Q2 2032 under certain conditions [7][8]. - Rigel notified Eli Lilly that it will not exercise its opt-in right for the development of ocadusertib, expecting to recognize approximately $40 million in non-cash revenue in Q2 2025 as a result [7][8]. Cost Structure - Total costs and expenses for Q1 2025 were $40.6 million, up from $36.5 million in Q1 2024, primarily due to increased personnel and research and development costs [8][26].