Rigel Pharmaceuticals, Inc. · NASDAQ:RIGL
Rigel Pharmaceuticals — Q3 2023 Earnings Presentation
30 slides from Rigel Pharmaceuticals's earnings presentation, Nov 7, 2023
Slide 1: Q3 2023 Financial Results Presentation
Q3 2023 Financial Results Presentation November 7, 2023 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, the potential and market opportunity of olutasidenib as therapeutics for R/R AML and other conditions
Slide 3: Rigel Participants
Rigel Participants Raul Rodriguez Ray Furey, J.D. President & Chief Executive Officer Executive Vice President, General Counsel & Corporate Secretary Dave Santos Dean Schorno Executive Vice President & Executive Vice President & Chief Commercial Officer Chief Financial Officer 3
Slide 4: Growing Our Business: Hematology/Oncology Focus
Growing Our Business: Hematology/Oncology Focus Commercial Execution Development & Expansion Development Programs TAVALISSE ® REZLIDHIA® in ITP in R/R AML • R2891 IRAK1/4 inhibitor Phase 1b trial in lower-risk MDS • Evaluating additional olutasidenib and fostamatinib opportunities In-license Opportu
Slide 5: Grow Sales of TAVALISSE in ITP
Grow Sales of TAVALISSE in ITP 5
Slide 6: TAVALISSE indication and select 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 7: TAVALISSE Q3 2023 Performance
TAVALISSE Q3 2023 Performance Bottles Shipped to Patients and Clinics 2500 2,412 Bottles Shipped to Patients and Clinics in Q3 2023 2000 1500 19% Growth Versus Q3 2022 1000 500 $24.5M Q3 2023 Net Product Sales Sales grew $5.3M (27%) vs Q3 2022 0 Q1 Q2 Q3 Q4 2019 2020 2021 2022 2023 7
Slide 8: New Patient Starts Continue to Drive Growth
New Patient Starts Continue to Drive Growth Consistent Quarterly Progress since Q2 2021 12% Compounded Annual Growth Rate (CAGR) 5.0 1,000 New Patient Starts per day Total New Patient Starts 4.0 800 3.0 600 2.0 400 1.0 200 0.0 0 2020 2021 2022 2023 (est) Q 0 Q 0 Q 0 Q 0 Q 1 Q 1 Q 1 Q 1 Q 2 Q 2 Q 2 Q
Slide 9: Expanding Our Commercial Heme/Onc Portfolio with REZLIDHIA
Expanding Our Commercial Heme/Onc Portfolio with REZLIDHIA 9
Slide 10: 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 28 & 29, including Boxed WARN
Slide 11: R/R AML Market Research
R/R AML Market Research HCPs continue to Patients continue to HCPs and patients perceive a significant fear relapse, and would both continue to unmet need in AML, benefit from the peace seek R/R AML particularly in the of mind associated therapies with a better R/R setting, for with therapies with b
Slide 12: mIDH1 R/R AML Market Overview
mIDH1 R/R* AML Market Overview1 2023 Incidence Over 20K patients2 FIT UNFIT ~60% of patients ~40% of patients R/R FIT R/R UNFIT Up to 60% relapse in 2 years Most are R/R in 2 years Primary Opportunity: mIDH1 Found in 6-9%3,4 of AML Near-term opportunity to impact the lives of ~1,000 mIDH1 R/R AML pa
Slide 13: REZLIDHIA Q3 2023 Performance
REZLIDHIA Q3 2023 Performance REZLIDHIA Launch-to-Date Sales 221 Bottles Shipped to Patients 250 and Clinics in Q3 2023 18% vs. Q2 2023 221 200 210 200 187 150 100 109 113 $2.7M Q3 2023 Net Product Sales 50 64 0 2 Bottles Shipped to Patients Total Bottles Sold $7.6M Launch Sales To-Date and Clinics
Slide 14: Institutional Adoption Improving
Institutional Adoption Improving Q3 REZLIDHIA New Patient Starts Higher Proportion of Business Driven by Institutions • Increased to highest level since 100% launch in September 13% 26% 25% 80% • Improved depth and breadth of Institutional adoption 60% ⎻ Compelling evidence in key mIDH1 R/R AML pati
Slide 15: REZLIDHIA Potential
REZLIDHIA Potential Promising treatment CR/CRh of 35% Strong efficacy for R/R AML (32% CR, 48% ORR) across R/R setting Targeted treatment 25.9 months median Well characterized across all IDH1 duration of CR/CRh safety profile mutation subtypes (28.1 months for CR) No requirement Potential benefit in
Slide 16: 65th Annual ASH Meeting and Exposition
65th Annual ASH Meeting and Exposition American Society of Hematology Booth # 2805 San Diego, CA - Dec 9-12, 2023 • Showcasing Rigel’s heme/onc portfolio • Important opportunity to increase awareness of Rigel, the Rigel pipeline, TAVALISSE and REZLIDHIA 16
Slide 17: Development Programs Update
Development Programs Update 17
Slide 18: Hematology/Oncology Pipeline Expansion
Hematology/Oncology Pipeline Expansion Development Opportunities In-Licensing Criteria Olutasidenib1 • AML • Differentiated asset(s) in hematology, oncology or • Glioma Leverage related areas • MDS Heme/Onc • Late-stage programs Capabilities • Synergistic to current in-house Fostamatinib1 capabiliti
Slide 19: 65th ASH Annual Meeting: Abstracts (Dec 9-12)
65th ASH Annual Meeting: Abstracts (Dec 9-12) 2888 Olutasidenib for the Treatment of mIDH1 Acute Myeloid Leukemia in Patients Relapsed or Refractory to Hematopoietic Stem Cell Transplant, Prior mIDH1 Inhibitor, or Venetoclax Jorge Cortes, Joseph G Jurcic, Maria Baer, William Blum, P Brent Ferrell, B
Slide 20: Lower-Risk MDS Treatment Landscape
Lower-Risk MDS Treatment Landscape • MDS is a clonal disorder of hematopoietic stem cells (HSCs) leading to dysplasia and ineffective hematopoiesis in the bone marrow • Risk of autoimmune abnormalities, cytopenias, progression to AML and death 1 2 X First-Line Therapy: Second-Line Therapy: Lenalidom
Slide 21: R289 Open-label Phase 1b Study in Lower-Risk MDS
R2891 Development: Open-label Phase 1b Study of Patients with Lower-Risk MDS Patients with Lower-Risk MDS Relapsed/Refractory or Inadequate Response to Prior Therapy with Known Clinical Benefit* Dose Escalation Phase Dose Expansion Phase Primary Endpoint: Standard 3+3 Design2 • Safety Cohort 4 – R28
Slide 22: RIPK1 Inhibitor Programs with Partner Lilly
RIPK1 Inhibitor Programs in Immune and CNS Diseases with Partner Lilly R5521 in 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 R552
Slide 23: Financials
Financials rigel.
Slide 24: Q3 2023 Financial Highlights
Q3 2023 Financial Highlights Net Product Sales ($M) Q3 ‘23 Net Product Sales: • TAVALISSE: $24.5M TAVALISSE REZLIDHIA 27.1 • REZLIDHIA: $2.7M 23.8 23.9 2.7 22.8 Q3 ‘23 Total Bottles Shipped: 19.2 0.9 1.5 2.6 18.6 • TAVALISSE: 2,551 17.1 17.6 16.2 16.0 • REZLIDHIA: 210 12.4 24.5 Q3 ‘23 Bottles Shippe
Slide 25: Q3 2023 Financial Results
Q3 2023 Financial Results (In thousands, except for per share amounts) Three Months Ended September 30, • In Q3 2023, contract revenues from Revenues 2023 2022 collaborations of $1.0M were from Net Product Sales $ 27,129 $ 19,188 Rigel’s agreement with Grifols Contract revenues from collaborations 1
Slide 26: 2023 and 2024 Value Drivers
2023 and 2024 Value Drivers Expanding Product Sales • Continue to broaden TAVALISSE and REZLIDHIA awareness and adoption – Promotional activities – Scientific education and publications – Maximizing access for patients • Identify ex-US collaboration(s) for olutasidenib Continued Financial Discipline
Slide 27: TAVALISSE 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 28: 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 29: 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 30: Thank You
Thank You www.rigel.com rigel.
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