Rigel Pharmaceuticals, Inc. · NASDAQ:RIGL
Rigel Pharmaceuticals — Q4 2023 Earnings Presentation
37 slides from Rigel Pharmaceuticals's earnings presentation, Mar 5, 2024
Slide 1: Q4 & FY 2023 Financial Results Presentation
Q4 & FY 2023 Financial Results Presentation March 5, 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 Francois Di Trapani Joseph Lasaga Dean Schorno Senior Vice President, Executive Vice P
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 Prog
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 ⎻ $10.0M payable upon fir
Slide 6: GAVRETO Approved in the U.S.
APPROVED IN THE U.S. GAVRETO is indicated for the treatment of adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer as detected by an FDA-approved test, and adult and pediatric patients 12 years of age and older with advanced or metastatic RE
Slide 7: Growing Our Oncology Targeted Therapy Portfolio
Growing Our Oncology Targeted Therapy Portfolio GAVRETO US Net Sales ($M)1 A compelling and synergistic opportunity 30.0 27.7 • Enables entry into a well-identified subset of large solid tumor market 25.0 22.8 – Immediately recognizable population of RET fusion-positive patients 20.0 – Challenging t
Slide 8: NSCLC and Treatment of RET fusion-positive Patients
NSCLC and Treatment of RET fusion-positive Patients ~235K Lung cancer patients in 20241 1L therapy for treatment eligible patients3 ~5% ~20% MKIs* ~15% Chemo+ICI _ ** ~41K ~3K RET fusion- GAVRETO positive patients2 ~75% treated with ~194K RET inhibitor ~60% * Multi-Kinase Inhibitors ** Immune Checkp
Slide 9: Pralsetinib Clinical Data Overview
Pralsetinib Clinical Data Overview
Slide 10: RET-altered Solid Tumors Have Been Underserved Historically
RET-altered Solid Tumors Have Been Underserved Historically1,2,3,4,5 Disease Overview Historical Medical Need l RET is one of the first oncogenic kinase fusions cloned from an epithelial tumor, an oncogenic driver primarily in solid tumors Non-selective therapies in RET+ NSCLC have poor outcomes wit
Slide 11: MKIs, Platinum-based Therapies and Immunotherapies Have Suboptimal Response Rates and PFS
MKIs, Platinum-based Therapies and Immunotherapies are Associated with Suboptimal Response Rates and PFS Studies Evaluating Kinase Inhibitors in Patients with RET Fusion-positive NSCLC Outcomes ORR (%) Median PFS (months) Vandetanib, Cabozantinib, Lenvatinib, 4.5-7.3 MKI 0 - 28% Sorafenib1,2,3,4,5 A
Slide 12: Targeted Therapies May Lead to Better Outcomes in Biomarker Driven Cancers
Targeted Therapies May Lead to Better Outcomes in Patients with Biomarker Driven Cancers • Evolution towards a biomarker driven strategy in NSCLC • Pralsetinib is an oral tyrosine kinase inhibitor that selectively and potently targets oncogenic RET fusions and mutations and has very low affinity for
Slide 13: Pralsetinib Has Shown Profound Clinical Benefit Regardless of Treatment History
Pralsetinib Has Shown Profound Clinical Benefit with Transformative Response Rates Regardless of Treatment History1 Phase 1: Phase 2: ARROW: Phase 1/2 Dose-escalation and Expansion Study Dose Escalation Expansion Cohorts Previously treated NSCLC (n=130)1 Treatment-naïve NSCLC (n=107)1 Pralsetinib: 3
Slide 14: CNS Metastases in Patients with RET fusion-positive NSCLC
The Development of CNS Metastases is Common and a Poor Prognostic Factor in Patients with RET fusion-positive NSCLC1 Data cutoff: March 4, 2022 Pralsetinib CNS Efficacy in RET fusion–positive NSCLC 2 All (n=15) CNS ORR, % (95% CI) 53.3 (26.6–78.7) CR, n (%) 3 (20.0) PR, n (%) 5 (33.3) n=8 Median DOR
Slide 15: Pralsetinib Has a Differentiated Value Proposition
Pralsetinib Has a Differentiated Value Proposition The only once daily, oral, precision therapy that selectively and potently inhibits RET alterations High and durable response rates regardless of treatment history Clinically proven to cross the blood-brain barrier Established safety and tolerabilit
Slide 16: GAVRETO Commercialization Plans
GAVRETO Commercialization Plans 16
Slide 17: Leveraging Rigel's Capabilities to Ensure Patient Access
Leveraging Rigel’s Capabilities to Ensure Patient Access Reimbursement and Distribution Patient Services Coverage 97% Commercial Coverage • Rigel’s wholesaler network • Over 7 years of experience in rare • Strong existing relationships matches >95% to current diseases working with patients, with PBM
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 Q3 choice • Staff dedicated to GAVRETO at RIGEL ONECARE will ensure high customer service • New patients enter the network via RIGEL ONECARE or
Slide 19: Key Drivers for Continued GAVRETO Growth
Key Drivers for Continued GAVRETO Growth Patient Identification1 • Awareness of the RET biomarker being associated with an FDA approved therapy is high and stable at ~90% • RET testing rate has directionally increased to ~80% of 1L NSCLC patients being tested ⎻ Testing rates are similar between acad
Slide 20: 2024 Commercialization Timeline
2024 Commercialization Timeline Q1 Q2 Q3 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 GAVR
Slide 21: TAVALISSE and REZLIDHIA 2023 Results
TAVALISSE and REZLIDHIA 2023 Results 21
Slide 22: Growing Annual Sales of TAVALISSE and REZLIDHIA
Growing Annual Sales of TAVALISSE and REZLIDHIA Total Net Product Sales ($M) 2023 Highlights 104 100 29 • Generated $104.3M in full-year 80 77 net product sales 62 63 – 36% ($28M) growth vs. 2022 23 60 27 18 18 44 19 • TAVALISSE generated $93.7M 40 16 14 16 24 – 24% ($18M) growth vs. 2022 12 19 20 1
Slide 23: Development Programs Update
Development Programs Update 23
Slide 24: Hematology and Oncology Pipeline Expansion
Hematology and Oncology Pipeline Expansion Development Opportunities1 In-Licensing & Product Acquisition Olutasidenib • Evaluate olutasidenib in a broad • Differentiated asset(s) in range of IDH1-mutant cancers hematology, oncology or Leverage related areas including AML, MDS and glioma Heme/Onc R28
Slide 25: Strategic Alliance with MD Anderson to Advance REZLIDHIA
Strategic Alliance with MD Anderson to Advance REZLIDHIA (olutasidenib) in AML and Other Cancers1 • Rigel and The University of Texas MD Anderson Cancer Center will evaluate olutasidenib, in combination with other agents, to treat newly diagnosed and relapsed or refractory patients with: − AML − Hig
Slide 26: Potential Olutasidenib Opportunity in Glioma
Potential Olutasidenib Opportunity in Glioma1 High Unmet Need Remains in Glioma Olutasidenib Activity in Enhancing Gliomas7 • Gliomas are a heterogeneous group of primary brain tumors that are associated with diffuse brain infiltration and premature death.2,3 • Diffuse gliomas are the most common pr
Slide 27: Collaboration with CONNECT for Phase 2 Trial of Olutasidenib in Glioma
Collaboration with CONNECT to Conduct a Phase 2 Trial of Olutasidenib in Glioma1 • Olutasidenib will be included in CONNECT’s TarGeT-D, a molecularly guided Phase 2 umbrella clinical trial for HGG • Rigel and CONNECT will evaluate olutasidenib in newly diagnosed pediatric and young adult patients (<
Slide 28: Financials
Financials rigel.
Slide 29: Q4 2023 Financial Highlights
Q4 2023 Financial Highlights Net Product Sales ($M) Q4 ‘23 Net Product Sales: • TAVALISSE: $25.7M TAVALISSE REZLIDHIA 29.5 27.1 • REZLIDHIA: $3.9M 3.9 23.8 23.9 2.7 22.8 1.5 Q4 ‘23 Total Bottles Shipped: 19.2 0.9 2.6 18.6 • TAVALISSE: 2,671 17.1 17.6 16.0 16.2 • REZLIDHIA: 308 12.4 24.5 25.7 Q4 ‘23
Slide 30: Q4 2023 Financial Results
Q4 2023 Financial Results (In thousands, except for per share amounts) • In Q4 2023, contract revenues from Three Months Ended December 31, Year Ended December 31, 2023 2022 2023 2022 Revenues Net Product Sales $ 29,539 $ 22,783 $ 104,294 $ 76,718 collaborations of $6.2M included: Contract revenues
Slide 31: 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 32: 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 33: 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 34: 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 35: 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 36: 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 37: Thank You
Thank You www.rigel.com rigel.
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