Summary of Rigel Pharmaceuticals FY Conference Call Company Overview - **Company**: Rigel Pharmaceuticals (NasdaqGS:RIGL) - **Date of Conference**: January 14, 2026 - **Speaker**: Raul Rodriguez, CEO and President Key Industry and Company Insights Strategic Objectives - Rigel's strategic plan includes four objectives: 1. Grow the commercial business 2. In-license and add products to the commercial portfolio 3. Advance the product pipeline in the clinic 4. Maintain financial discipline [2][4][41] Historical Growth - In 2020, Rigel was a one-product company with Tavalisse for adult chronic ITP. - By 2025, the company expanded to three commercial products: Tavalisse, Rezlidhia, and Gavreto, with four different indications [3][4]. Financial Performance - Rigel became profitable in Q3 2024, generating $100 million in cash since then [4]. - The company reported a 35% sales growth from 2022, projecting total revenue of $275-$290 million for the year, with product revenue between $255-$265 million [6][42]. Product Performance Tavalisse - Tavalisse sales grew by 47%, reaching $45 million, with a significant patient population of approximately 24,000 in the U.S. [7][9]. - The product is used primarily in patients who have failed first-line steroid treatments [10][11]. - The Inflation Reduction Act positively impacted patient retention on Tavalisse, reducing dropout rates due to affordability issues [12][13]. Rezlidhia - Rezlidhia targets adult patients with relapsed or refractory AML with an IDH1 mutation, addressing a significant unmet need [14][15]. - The product achieved a CR/CRH rate of 35% with a durability of response lasting 25 months [16]. Gavreto - Gavreto is indicated for non-small cell lung cancer and thyroid cancer with RET fusion-positive mutations, showing good sales growth from $7 million to over $10 million per quarter [17][18]. Pipeline Development R289 (IRAK1 and 4 Inhibitor) - R289 is being studied in low-risk MDS, with potential for significant market opportunities estimated in the multi-hundred million to billion-dollar range [6][29]. - The product has received fast track and orphan designation from the FDA, with ongoing studies to evaluate its efficacy in treating low-risk MDS [25][39]. Future Plans - Rigel aims to launch additional products in the Heme-Onc space by 2026-2028, focusing on late-stage assets with registrational data [20][21]. - The company is exploring other indications for R289, leveraging its unique mechanism of action in inflammatory modulation [43][44]. Financial Discipline - Rigel has maintained a strong cash position, doubling its cash reserves to $154 million in 2025, allowing for further investment in pipeline development [41]. - The company emphasizes maintaining low operational expenses while growing revenue, achieving a balance that supports profitability [40]. Conclusion - Rigel Pharmaceuticals is positioned for continued growth with a diversified product portfolio and a promising pipeline. The company is focused on expanding its commercial business, advancing its development pipeline, and maintaining financial discipline to support future initiatives [41][42].

Core Insights - Rigel Pharmaceuticals reported strong financial performance in 2025, with record net product sales and significant cash generation, anticipating continued growth in 2026 [2][4][11] Financial Performance - Preliminary total revenue for Q4 2025 is expected to be approximately $69.8 million, a 21% increase from $57.6 million in Q4 2024 [5] - For the full year 2025, total revenue is projected to be $294.3 million, up from $179.3 million in 2024, representing a growth of 64% [5] - Net product sales for 2025 are expected to be $232.0 million, a 60% increase compared to 2024 [7] Product Sales Breakdown - Q4 2025 net product sales include: - TAVALISSE: $45.6 million, up from $31.0 million in Q4 2024 - GAVRETO: $10.2 million, up from $8.1 million in Q4 2024 - REZLIDHIA: $9.6 million, up from $7.4 million in Q4 2024 [5] Clinical Development - Rigel is advancing its Phase 1b clinical study of R289 for lower-risk MDS, with preliminary data indicating 33% of patients achieved red blood cell transfusion independence [9] - The company plans to complete enrollment in the dose expansion phase of the R289 study by the second half of 2026 and share preliminary results by the end of 2026 [9][11] 2026 Outlook - Rigel anticipates total revenue for 2026 to be between $275 million and $290 million, with net product sales projected at $255 million to $265 million [11] - The company expects to report positive net income for the full year 2026 while funding existing and new clinical development programs [11]

Core Insights - Rigel Pharmaceuticals announced updated data from its ongoing Phase 1b study of R289, an oral prodrug of R835, targeting relapsed or refractory lower-risk myelodysplastic syndrome (MDS) [1][2] - The study results were presented at the 67th American Society of Hematology Annual Meeting, highlighting the potential of R289 as a treatment option for patients with transfusion-dependent lower-risk MDS [1][2] Study Overview - The Phase 1b study is evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of R289 in patients with relapsed or refractory lower-risk MDS [2] - Enrollment in the dose escalation phase was completed in July 2025, with the dose expansion phase starting in October 2025, involving up to 40 patients [2] Key Data Highlights - As of October 28, 2025, 33 patients were enrolled, with a median age of 75 and a median of 3 prior therapies [4] - R289 was generally well tolerated, with 33% of evaluable transfusion-dependent patients achieving durable red blood cell transfusion independence (RBC-TI) [3][4] - The most common treatment-emergent adverse events included diarrhea (30%), constipation (27%), and fatigue (27%) [4] Efficacy Results - Among evaluable transfusion-dependent patients, 6 out of 18 (33%) achieved RBC-TI lasting more than 8 weeks, with a median time to onset of 1.9 months [4] - Peak hemoglobin increases ranged from 2.9 to 6.1 g/dL compared to baseline in patients achieving RBC-TI [4] Regulatory Designations - R289 has received Orphan Drug designation and Fast Track designation from the FDA for the treatment of previously-treated transfusion-dependent lower-risk MDS [5]

Financial Performance & Guidance - Q3 2025 net product sales grew to $64.1 million, a 65% increase compared to Q3 2024[10, 158] - Rigel increased its 2025 net product sales guidance to $225 million - $230 million, up from $210 million - $220 million[12] - Rigel anticipates 2025 total revenue of ~$285 million to $290 million[162] - Cash, cash equivalents & short-term investments as of September 30, 2025, was $137.1 million compared to $77.3 million as of December 31, 2024[162] Product Performance - TAVALISSE Q3 2025 net product sales reached $44.7 million, a 70% increase compared to Q3 2024[16] - GAVRETO Q3 2025 net product sales reached $11.1 million, a 56% increase compared to Q3 2024[16] - REZLIDHIA Q3 2025 net product sales reached $8.3 million, a 50% increase compared to Q3 2024[16] R289 Clinical Development - In a Phase 1b study in R/R lower-risk MDS, 33% (6/18) of evaluable transfusion-dependent patients receiving ≥500 mg QD achieved RBC-TI >8 weeks[124, 131] - The median duration of RBC-TI was 22.9 weeks (9 - 104.3)[124] Strategic Collaborations - Contract revenues from collaborations were $5.4 million in Q3 2025[158]

Summary of Rigel Pharmaceuticals Conference Call Company Overview - Rigel Pharmaceuticals is a hematology and oncology biotech company focused on expanding its commercial business and pipeline [2][3] Commercial Products - Rigel has three approved products: - **TAVALISSE**: Indicated for immune thrombocytopenia (ITP) with net sales of $44.7 million last quarter, a 70% increase year-over-year [6] - **REZLIDHIA**: Approved for mutant IDH1 relapsed and refractory acute myeloid leukemia (AML) with sales of $8.3 million, a 50% growth from the previous year [6] - **GAVRETO**: Approved for RET fusion positive non-small cell lung cancer and thyroid cancer, with sales increasing from $7 million to $11.1 million [6][12] Financial Performance - Rigel reported $64 million in net product sales last quarter, a 65% increase from the same quarter last year, and $166 million over three months, surpassing total sales for all of 2024 [5] - The company generated $60 million in cash this year and has maintained profitability [4][30] - Guidance for revenue is set at $285-$290 million, with net product sales expected to be $225-$230 million [30] Pipeline Development - Rigel is focused on developing transformational programs, particularly R289 for low-risk myelodysplastic syndromes (MDS) [4][17] - R289 has received fast-track and orphan designations from regulatory agencies, indicating its potential for significant improvement in treatment options [20] - The company plans to initiate a registration study for R289 in 2027 [24] Market Opportunities - The U.S. market for adult chronic ITP has approximately 81,000 patients, with Rigel targeting the second-line treatment population of about 24,000 patients [7] - The market for low-risk MDS is substantial, with current treatments showing limited efficacy, presenting an opportunity for R289 [18][19] Strategic Partnerships - Rigel has partnered with various companies for product distribution, including Grifols in Europe and Kissei in Asia for TAVALISSE [13] - Collaborations with MD Anderson and MyeloMatch are underway to explore additional indications for Olutasidenib and AML treatments [25][27] Future Outlook - Rigel aims to continue in-licensing differentiated assets in hematology and oncology to enhance its portfolio [14][16] - The company is committed to maintaining financial discipline while investing in its pipeline to drive growth [31][32] Key Takeaways - Rigel Pharmaceuticals is experiencing significant growth in its commercial products and is strategically positioning itself for future opportunities in hematology and oncology [5][32] - The focus on developing innovative treatments like R289 and expanding its product offerings through partnerships is central to Rigel's growth strategy [4][14][24]

Financial Data and Key Metrics Changes - The company reported total revenue of $69.5 million for Q3 2025, including record net product sales of $64.1 million, a 65% year-over-year increase [4][27] - Net income for the third quarter was $27.9 million, compared to $12.4 million for the same period in 2024 [29] - Cash balance increased to $137.1 million, up from $77.3 million at the end of 2024 [29] Business Line Data and Key Metrics Changes - TAVALISSE generated $44.7 million in net product sales, a 70% increase year-over-year [11][27] - GAVRETO achieved $11.1 million in net product sales, reflecting a 56% increase compared to Q3 2024 [12][27] - REZLIDHIA reported $8.3 million in net product sales, a 50% increase year-over-year [12][27] Market Data and Key Metrics Changes - The company has expanded access to TAVALISSE in Japan, Europe, Canada, Israel, and South Korea, with ongoing regulatory approvals in new markets [13] - The commercial portfolio has shown strong year-over-year growth, with net product sales exceeding $200 million on a trailing 12-month basis [11] Company Strategy and Development Direction - The strategic objectives focus on growing the hematology and oncology business through commercial performance and pipeline expansion [4] - The company is pursuing additional in-licensing deals or asset acquisitions to achieve significant growth [7] - The 2025 revenue guidance has been raised to $285-$290 million, reflecting anticipated growth of 55%-59% compared to 2024 [9][30] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to achieve significant long-term growth through strong commercial execution and financial discipline [9][32] - The company aims to continue driving sales of commercial products while funding key development programs in its internal pipeline [31][32] Other Important Information - The company is advancing its development pipeline, including the ongoing phase 1b study of R289 and collaborations for olutasidenib in various cancer studies [5][16] - The company has received fast-track designation and orphan drug designation from the FDA for R289, indicating a promising regulatory pathway [19] Q&A Session Summary Question: Competitive positioning of R289 in lower-risk MDS versus Rytelo - Management indicated it is too early to speculate on competitive positioning and plans for a registrational study [34] Question: Data needed for potential priority review of R289 - Management noted that the fast-track designation opens potential for priority review, but further data from the dose expansion study is needed [38] Question: Expectations for updated data at ASH for R289 - Management confirmed that updated data will include 16 weeks of follow-up on all patients, providing a robust data set for presentation [40]

Financial Performance & Guidance - Rigel increased its 2025 net product sales guidance from approximately $210 million - $220 million to approximately $225 million - $230 million[15, 89] - Q3 2025 net portfolio sales grew by $25.2 million, a 65% increase compared to Q3 2024[24] - Q3 2025 net product sales were $64.1 million[84] - Rigel anticipates 2025 total revenue of approximately $285 million to $290 million, an increase from the previous guidance of approximately $270 million to $280 million[88] - Cash, cash equivalents, and short-term investments as of September 30, 2025, were $137.1 million, compared to $77.3 million as of December 31, 2024[87] Product Sales Performance - TAVALISSE Q3 2025 net product sales were $44.7 million[27, 86] - GAVRETO Q3 2025 net product sales were $11.1 million[27, 86] - REZLIDHIA Q3 2025 net product sales were $8.3 million[27, 86] R289 Clinical Development - R289 is under evaluation in a Phase 1b study for patients with lower-risk MDS[14, 43] - The FDA granted Fast Track designation for R289 for previously-treated transfusion-dependent lower-risk MDS and Orphan Drug designation for MDS[42, 43] Strategic Collaborations - Grifols collaboration revenues were $3.1 million in Q3 2025[34, 86] - Kissei collaboration revenues were $1.8 million in Q3 2025[34, 86] - Medison collaboration revenues were $0.2 million in Q3 2025[34, 86]

Core Insights - Rigel Pharmaceuticals reported strong third-quarter performance, leading to an increase in full-year 2025 revenue guidance due to outstanding commercial execution and pipeline development [2][10]. Financial Performance - Total revenues for Q3 2025 were $69.5 million, comprising $64.1 million in net product sales (up 65% from $38.9 million in Q3 2024) and $5.4 million in contract revenues [4][10]. - Net product sales for TAVALISSE reached $44.7 million (70% growth), GAVRETO at $11.1 million (56% growth), and REZLIDHIA at $8.3 million (50% growth) compared to the same period in 2024 [4][11]. - For the nine months ended September 30, 2025, total revenues were $224.5 million, with net product sales growing 69% year-over-year [7]. Costs and Expenses - Total costs and expenses for Q3 2025 were $41.0 million, slightly down from $41.3 million in Q3 2024, primarily due to lower costs of product sales [5][10]. - Research and development costs increased due to clinical activities related to olutasidenib and R289, along with higher personnel-related costs [5][8]. Net Income - Rigel reported a net income of $27.9 million for Q3 2025, compared to $12.4 million in Q3 2024, translating to $1.55 basic and $1.46 diluted earnings per share [6][10]. Cash Position - As of September 30, 2025, cash, cash equivalents, and short-term investments totaled $137.1 million, up from $77.3 million at the end of 2024 [9][10]. Clinical Development - Rigel is advancing its Phase 1b study of R289 for lower-risk MDS, with enrollment completed in the dose escalation phase and the first patient enrolled in the dose expansion phase [2][11]. - Updated data from the R289 study will be presented at the ASH Annual Meeting in December [10][11]. 2025 Outlook - The company updated its 2025 revenue guidance to approximately $285 to $290 million, an increase from the previous estimate of $270 to $280 million [12][24]. - Rigel anticipates reporting positive net income for the full year 2025 while funding existing and new clinical development programs [12].

Core Insights - Rigel Pharmaceuticals is set to present data from its ongoing Phase 1b study of R289, a dual IRAK1/4 inhibitor, at the 67th American Society of Hematology (ASH) Annual Meeting on December 7, 2025, focusing on patients with relapsed or refractory lower-risk myelodysplastic syndrome (MDS) [1][2][5] - The ASH Annual Meeting will also feature four poster presentations regarding REZLIDHIA (olutasidenib) for treating relapsed or refractory mutated isocitrate dehydrogenase-1 (mIDH1) acute myeloid leukemia (AML) [1][5] R289 Study Details - The Phase 1b study of R289 has enrolled 33 patients as of July 15, 2025, with a median age of 75 and a median of 3 prior therapies; 61% of these patients had a high transfusion burden at baseline [6] - R289 was administered at doses ranging from 250 mg once daily to 500 mg twice daily, with the most common treatment-emergent adverse events being diarrhea (28.1%), constipation (25%), and increased creatinine/ALT (21.9%) [6] - Among evaluable transfusion-dependent patients receiving doses of at least 500 mg, 31% achieved durable red blood cell transfusion independence for over 8 weeks, with a median time to onset of 2.2 months and a median duration of 24.3 weeks [6] REZLIDHIA Data Highlights - In a pivotal cohort of the Phase 2 registrational study involving 147 patients with R/R mIDH1 AML, 24% maintained stable disease after two treatment cycles, with a subsequent response rate of 33% [9] - The median overall survival for late responders was reported at 23.9 months, indicating that patients with stable disease after two cycles may benefit from continued treatment [9][10] - The overall response rate in a real-world cohort of olutasidenib-treated patients was 50%, supporting its use as a viable therapeutic option in post-venetoclax treatment settings [9][10] Company Overview - Rigel Pharmaceuticals, Inc. is a biotechnology company focused on developing therapies for hematologic disorders and cancer, founded in 1996 and based in South San Francisco, California [26]

Core Insights - Rigel Pharmaceuticals (RIGL) is set to report its third-quarter 2025 results on November 4, with revenue expectations at $61.6 million and earnings at 93 cents per share [1][6] Group 1: Revenue Drivers - The primary revenue sources for Rigel include sales from marketed products and contract revenues from collaborations [2] - The significant revenue growth in Q3 is anticipated to be driven by strong demand for Tavalisse, which treats chronic immune thrombocytopenia (ITP) [2][6] - Sales from other marketed products, Rezlidhia (olutasidenib) and Gavreto (pralsetinib), are also expected to contribute positively to Rigel's revenue in the upcoming quarter [3][6] Group 2: Stock Performance - Year-to-date, Rigel's shares have increased by 88%, significantly outperforming the industry average rise of 7.3% [3] Group 3: Pipeline Developments - Rigel is advancing its pipeline with R289, a dual IRAK1 and IRAK4 inhibitor, currently in early-stage studies for lower-risk myelodysplastic syndrome (MDS) [4] - The company is also exploring additional uses for Rezlidhia beyond its current approval for relapsed or refractory IDH1-mutated acute myeloid leukemia (AML) [7] Group 4: Earnings Surprise History - Rigel has a strong history of earnings surprises, having exceeded earnings expectations in the last four quarters with an average surprise of 1,840.49% [8] Group 5: Earnings Prediction Model - The current model does not predict a definitive earnings beat for Rigel, as the Earnings ESP stands at 0.00% with both the Most Accurate Estimate and the Zacks Consensus Estimate at 93 cents per share [9][10]