Rigel Pharmaceuticals, Inc. · NASDAQ:RIGL
Rigel Pharmaceuticals — Q1 2024 Earnings Presentation
43 slides from Rigel Pharmaceuticals's earnings presentation, May 7, 2024
Slide 1: Q1 2024 Financial Results Presentation
Q1 2024 Financial Results Presentation May 7, 2024 1
Slide 2: Forward Looking Statements
Forward Looking Statements This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1955 (“PSLRA”) relating to, among other things, expected commercial and financial results; Rigel’s ability to earn and receive milestone payments; ex
Slide 3: Rigel Participants
Rigel Participants Raul Rodriguez Ray Furey, J.D. Dave Santos President & Executive Vice President, Executive Vice President & Chief Executive Officer General Counsel & Corporate Secretary Chief Commercial Officer Lisa Rojkjaer, M.D. Dean Schorno Executive Vice President & Executive Vice President &
Slide 4: Growing Our Hematology and Oncology Business
Growing Our Hematology and Oncology Business Commercial Execution Expansion & Development In-Licensing and Product Acquisition • GAVRETO® (pralsetinib) added to existing commercial and medical affairs operations • New late-stage assets which leverage current capabilities and capacity Development Pro
Slide 5: Acquired U.S. Rights to GAVRETO
Acquired U.S. Rights to GAVRETO® GAVRETO (pralsetinib) is a once daily, small • Established U.S. marketed product molecule, oral, kinase inhibitor of wild-type RET (rearranged during transfection) and • Blueprint will receive a purchase price of $15.0M oncogenic RET fusions ⎻ $10.0M payable upon fir
Slide 6: Grow Sales of TAVALISSE in ITP
Grow Sales of TAVALISSE in ITP 6
Slide 7: TAVALISSE indication and safety information
Kinase inhibitor indicated for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (cITP) who have had an insufficient response to a previous treatment. Select Important Safety Information Adverse Reactions: • Serious adverse drug reactions in the ITP double-blin
Slide 8: TAVALISSE Q1 2024 Performance
TAVALISSE Q1 2024 Performance Bottles Shipped to Patients and Clinics 2500 2,483 Bottles Shipped to Patients and Clinics in Q1 2024 2000 1500 10% Growth Versus Q1 2023 1000 500 $21.1M Q1 2024 Net Product Sales 0 Q1 Q2 Q3 Q4 2020 2021 2022 2023 2024 8
Slide 9: TAVALISSE New Patient Starts Continue to Drive Growth
TAVALISSE New Patient Starts Continue to Drive Growth New Patient Starts by Quarter Drivers of Consistent Quarterly Progress Since 2021 • Continued focus on increasing the breadth and depth of New Patient Starts among prescribers • Ensuring strong coverage and reimbursement with >95% commercial cove
Slide 10: Grow Sales of REZLIDHIA in mIDH1 R/R AML
Grow Sales of REZLIDHIA in mIDH1 R/R AML 10
Slide 11: REZLIDHIA approved and available in the U.S.
APPROVED AND AVAILABLE IN THE U.S. REZLIDHIA is indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible IDH1 mutation as detected by an FDA-approved test. Please see Important Safety Information on slides 39 & 40, including Boxed WARN
Slide 12: REZLIDHIA Q1 2024 Performance
REZLIDHIA Q1 2024 Performance Rezlidhia Launch-to-Date Sales 400 326 Bottles Shipped to Patients 390 350 and Clinics in Q1 2024 326 17% vs. Q4 2023 300 308 278 199% vs. Q1 2023 250 200 221 210 200 $4.9M 187 150 Q1 2024 Net Product Sales 100 109 113 64 50 26% vs. Q4 2023 2 227% vs. Q1 2023 0 Bottles
Slide 13: REZLIDHIA Continued Growth Driven by Institutions
REZLIDHIA Continued Growth Driven by Institutions Institutional use accounted for >84% of business in Q1 Q1 2024 REZLIDHIA New Patient Starts 350 326 • Institutional new patient starts Bottles Shipped to Patients and Clinics 300 278 51 continued to grow in breadth and depth with academic AML treater
Slide 14: GAVRETO Commercialization Plans
GAVRETO Commercialization Plans 14
Slide 15: GAVRETO approved in the U.S.
APPROVED IN THE U.S. GAVRETO is indicated for the treatment of adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer as detected by an FDA-approved test, and adult and pediatric patients 12 years of age and older with advanced or metastatic RE
Slide 16: Growing Our Oncology Targeted Therapy Portfolio
Growing Our Oncology Targeted Therapy Portfolio A Compelling and Synergistic Opportunity 1L Treatment of RET fusion-positive NSCLC Patients1 • Enables entry into a well-identified subset of large solid tumor market – Immediately recognizable population of RET fusion-positive patients – Challenging t
Slide 17: GAVRETO Drivers and Opportunities for Growth
GAVRETO Drivers and Opportunities for Growth EXPAND OPTIMIZE MAXIMIZE ENSURE Patient Identification Choice of Therapy Carryover Patient Access • High awareness of RET • Most oncologists have not • High response rates in both • Access to coverage, • Testing rate increasing tried GAVRETO in 1L RET tre
Slide 18: Committed to Access Without Interruption
Committed to Access Without Interruption Ready to serve current and newly prescribed patients • Rigel’s Limited Network will ensure provider and patient Q2 choice July • Staff dedicated to GAVRETO at RIGEL ONECARE will ensure high customer service • New patients enter the network via RIGEL ONECARE o
Slide 19: 2024 Commercialization Timeline
2024 Commercialization Timeline Q1 Q2 July Q4 •Prepare distribution network •RIGEL ONECARE implements •Begin distributing and •Continue expanding plan to transition current and promoting GAVRETO to breadth of prescribers newly prescribed GAVRETO customers •Increase academic and patients •Focus on GA
Slide 20: GAVRETO (pralsetinib) Clinical Overview
GAVRETO (pralsetinib) Clinical Overview
Slide 21: Biomarker-Based Therapy is Standard of Care for NSCLC
Biomarker-Based Therapy is Standard of Care for NSCLC RET-fusion positive cancers RET-fusion positive NSCLC Suboptimal responses with platinum-based l RET fusions are present in ~2% of NSCLC1,2, the most common type of lung cancer, and ~20% of papillary regimens (ORR ~50%; median PFS: 6-8m)4 thyroid
Slide 22: Pralsetinib in RET Fusion+ Solid Tumors: ARROW Study Results
Pralsetinib in RET Fusion + Solid Tumors: Updated Results from the Phase 1/2 “ARROW” Study Potential for better response rates when used first-line in NSCLC1 Phase 1: Dose Escalation Phase 2 Pralsetinib 30-600 mg RP2D: 400 mg QD QD or BID Prior platinum treatment (n=130) Treatment-naïve (n=107) 20 2
Slide 23: Intracranial Efficacy in NSCLC Patients with Brain Metastases
Promising Intracranial Efficacy in NSCLC Patients with Brain Metastases – ARROW Study1 25% of RET fusion-positive NSCLC patients have brain metastases at diagnosis2 Intracranial response in patients with measurable CNS metastases at baseline (n=15) 1 N=15 CNS ORR, % (95% CI) 53.3 (26.6–78.7) CR, n (
Slide 24: Pralsetinib Has a Differentiated Value Proposition
Pralsetinib Has a Differentiated Value Proposition The only once daily, oral, RET inhibitor approved for patients with NSCLC and thyroid cancer with RET gene fusions High and durable response rates regardless of prior treatment history1 Promising intracranial efficacy in patients with brain metastas
Slide 25: Clinical Development Program Update
Clinical Development Program Update 25
Slide 26: Hematology and Oncology Pipeline Expansion
Hematology and Oncology Pipeline Expansion Development Opportunities1 In-Licensing & Product Acquisition Olutasidenib • Broad range of IDH1-mutant • Differentiated asset(s) in cancers including AML, MDS and hematology, oncology or glioma Leverage related areas Heme/Onc • Late-stage programs Capabili
Slide 27: Strategic Alliance with MD Anderson to Advance REZLIDHIA
Strategic Alliance with MD Anderson to Advance REZLIDHIA (olutasidenib) in AML and Other Cancers1 • Rigel and The University of Texas MD Anderson Cancer Center will evaluate olutasidenib in combination with other agents to treat newly-diagnosed and relapsed/refractory patients with IDH1-mutated: − A
Slide 28: Collaboration with CONNECT: Phase 2 Olutasidenib Trial in Glioma
Collaboration with CONNECT to Conduct a Phase 2 Trial with Olutasidenib in Glioma1 • Gliomas account for 29-35% of CNS tumors in children, adolescents and young adults; approximately 1/3 are high grade gliomas (HGG) (800-1000 new cases/year in US)2 • IDH1 mutations are found in up to 36% of HGGs in
Slide 29: Lower-Risk MDS Treatment Landscape
Lower-Risk MDS (LR-MDS) Treatment Landscape • MDS is a heterogeneous group of diseases primarily of the elderly characterized by cytopenias and increased risk of transformation to AML. • Therapeutic strategy depends upon MDS risk classification (IPSS scoring system). • Goal of treatment for LR-MDS:
Slide 30: Dual Targeting of IRAK1 & IRAK4 Pathways in MDS by R289
Dual Targeting of the IRAK1 & IRAK4 Pathways in MDS by R289, a Novel Dual IRAK1 & IRAK4 Inhibitor1 Dysregulation of immune/inflammatory signaling pathways is associated with MDS • Chronic stimulation of both the interleukin-1 receptor (IL-1R) and toll-like receptor (TLR) pathways leads to a proinfla
Slide 31: R289 Phase 1b Trial in Relapsed/Refractory Lower-Risk MDS
R2891: Phase 1b Trial in Relapsed/Refractory Lower-Risk MDS Open-label, multicenter trial to evaluate the safety, tolerability, PK and preliminary activity of R289 in patients with LR-MDS (NCT05308264) Dose Escalation Phase Dose Expansion Phase Standard 3+3 Design2 Primary Endpoints: • Incidence of
Slide 32: RIPK1 Inhibitor Programs with Partner Lilly
RIPK1 Inhibitor Programs in Immune and CNS Diseases with Partner Lilly Immune Diseases • R552, a potent and selective RIPK1 inhibitor, completed a Phase 1 study which demonstrated potential best-in-class status compared to competition • Lilly initiated a Phase 2a clinical trial studying LY3871801(pr
Slide 33: Financials
Financials rigel.
Slide 34: Q1 2024 Financial Highlights
Q1 2024 Financial Highlights Net Product Sales ($M) Q1 ‘24 Net Product Sales: • TAVALISSE: $21.1M TAVALISSE REZLIDHIA 29.5 27.1 • REZLIDHIA: $4.9M 3.9 26.0 23.8 23.9 2.7 22.8 1.5 Q1 ‘24 Total Bottles Shipped: 19.2 0.9 2.6 4.9 18.6 • TAVALISSE: 2,193 16.2 • REZLIDHIA: 390 24.5 25.7 Q1 ‘24 Bottles Shi
Slide 35: Q1 2024 TAVALISSE Net Sales
Q1 2024 TAVALISSE Net Sales Sequential Impact from Decrease in Bottles Remaining in Distribution Channel Bottle Volume Net Product Sales ($M) 3100 30 2671 25.7 0.2 2600 2463 2483 25 2193 21.1 2100 20 -4.8 1600 15 1100 10 600 5 208 100 0 -400 -290 Q4’23 Net Change in Change in Q1’24 Net Bottles to Pa
Slide 36: Q1 2024 Financial Results
Q1 2024 Financial Results (In thousands, except for per share amounts) Three Months Ended March 31, • In Q1 2024, contract revenues from 2024 2023 Revenues collaborations of $3.5M included: Net Product Sales $ 26,003 $ 23,745 Contract revenues from collaborations 3,531 2,325 • Kissei $2.3M Total rev
Slide 37: 2024 Value Drivers
2024 Value Drivers Expanding Product Sales for TAVALISSE and REZLIDHIA • Continue to broaden TAVALISSE and REZLIDHIA awareness and adoption • Identify ex-US collaboration(s) for olutasidenib Commercialize GAVRETO • Effectively add to Rigel’s commercial business Continued Financial Discipline Develop
Slide 38: TAVALISSE Indication and Important Safety Information
TAVALISSE® (fostamatinib disodium hexahydrate) Tablets DRUG INTERACTIONS • Concomitant use of TAVALISSE with strong CYP3A4 inhibitors increases exposure to the INDICATION major active metabolite of TAVALISSE (R406), which may increase the risk of adverse reactions. Monitor for toxicities that may re
Slide 39: About REZLIDHIA (olutasidenib)
About REZLIDHIA® (olutasidenib) INDICATION REZLIDHIA is an isocitrate dehydrogenase-1 (IDH1) inhibitor indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible IDH1 mutation as detected by an FDA-approved test. IMPORTANT SAFETY INFORMA
Slide 40: Important Safety Information (Cont.)
IMPORTANT SAFETY INFORMATION (Cont.) WARNINGS AND PRECAUTIONS Hepatotoxicity Monitor patients frequently for clinical symptoms of hepatic dysfunction such as fatigue, anorexia, right upper abdominal discomfort, dark urine, or jaundice. Obtain baseline liver function tests prior to initiation of REZL
Slide 41: About GAVRETO (pralsetinib)
About GAVRETO® (pralsetinib) INDICATIONS GAVRETO (pralsetinib) is indicated for the treatment of: • Adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA-approved test • Adult and pediatric patients 12 years of ag
Slide 42: Important Safety Information (Cont.)
IMPORTANT SAFETY INFORMATION (Cont.) • Risk of Impaired Wound Healing: Impaired wound healing can occur in patients who receive drugs that inhibit the vascular endothelial growth factor (VEGF) signaling pathway. Therefore, GAVRETO has the potential to adversely affect wound healing. Withhold GAVRETO
Slide 43: Thank You
Thank You www.rigel.com rigel.
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