RedHill Biopharma Ltd. · NASDAQ:RDHL
RedHill Biopharma — Q3 2021 Earnings Presentation
46 slides from RedHill Biopharma's earnings presentation, Nov 30, 2021
Slide 1: Third Quarter 2021 Financial Results and Operational Highlights
RedHill Biopharma (“RDHL”) Third Quarter 2021 Financial Results and Operational Highlights November 30, 2021 1
Slide 2: Forward Looking Statement
Forward Looking Statement This presentation does not constitute an offer or invitation to sell or issue, or any solicitation of an offer to subscribe for or acquire any of the Company’s securities or to participate in any investment in the Company. No representation or warranty is made to the accura
Slide 3: Opening Remarks
Opening Remarks Third Quarter 2021 Financial Results and Operational Highlights November 30, 2021 Dror Ben-Asher Chief Executive Officer 3
Slide 4: Corporate Highlights
Corporate Highlights Third Quarter 2021 Financial Results and Operational Highlights November 30, 2021 Guy Goldberg Chief Business Officer 4
Slide 5: Q3/2021 Highlights
Q3/2021 Highlights Financials • Strong quarterly revenues of $21.6 million • Talicia: 15% Q/Q growth in new prescription volume with continued achievement of launch milestones; improving coverage has set stage for potentially strong Q4/2021 • Movantik: Maintained market leadership position with stro
Slide 6: Emerging U.S. Specialty Pharma: Select Programs
Emerging U.S. Specialty Pharma: Select Programsi Commercial Productsii Talicia® (omeprazole magnesium, amoxicillin and rifabutin) - H. pylori infection in adults iii Movantik® (naloxegol) - Opioid induced constipation (OIC) in adults with chronic non-cancer pain Aemcolo® (rifamycin) - Travelers’ dia
Slide 7: COVID-19 Programs
COVID-19 Programs Potential Against Emerging Variants, including Omicron Third Quarter 2021 Financial Results and Operational Highlights November 30, 2021 Gilead Raday Chief Operating Officer 7
Slide 8: Opaganib - Advanced Oral Pill for COVID-19
Opaganib - Advanced Oral Pill for COVID-19 ➔ Opaganib shows apparent benefit in survival of moderately severe hospitalized COVID-19 patients* Phase 2/3 ➔ An underserved population which the COVID-19 Study Pfizer and Merck pills do not address 230 additional people treated with opaganib - totaling 46
Slide 9: Opaganib Proposed Anti-Viral MoA Independent of Omicron Spike-Protein Mutations
Opaganib Proposed Anti-Viral MoA is Independent of Omicron’s Spike-Protein Mutations Opaganib’s proposed action on the intracellular replication transcription complex isn’t affected by the changes in viral spike-protein of the Omicron variant (or other potential such variants) which are raising glob
Slide 10: Opaganib Anti-Inflammatory MoA Independent of Omicron Mutations
Opaganib Proposed Anti-Inflammatory MoA also Independent of Omicron’s Spike-Protein Mutations Opaganib’s anti-inflammatory activity isn’t limited by the changes in viral spike- protein of the Omicron variant (or other potential such variants) allowing the anti-inflammatory benefit to be maintained f
Slide 11: Opaganib Anti-Inflammatory MoA Independent of Omicron Mutations
Opaganib Proposed Anti-Inflammatory MoA also Independent of Omicron’s Spike-Protein Mutations Opaganib’s anti-inflammatory activity isn’t limited by the changes in viral spike- protein of the Omicron variant (or other potential such variants) allowing the anti-inflammatory benefit to be maintained f
Slide 12: Opaganib Reduced Mortality Rate in Lower Oxygen Subpopulation
Opaganib Reduced Mortality Rate For Subpopulation of Subjects with Lower Oxygen Supplementation at Baseline (<=60% FiO2) Higher mortality in the placebo arm versus the opaganib arm (15.7% [21/134] vs. 6% [7/117], a significant 62% benefit; nominal p-value 0.019) Kaplan-Meier Curves of Time to Death
Slide 13: Opaganib Benefited Reaching Room Air in Lower Oxygen Subpopulation
Opaganib Benefited Reaching Room Air in Subpopulation with Lower Oxygen Supplementation at Baseline (<=60% FiO2) • These are 251/463 subjects (54% of mITT) requiring Fraction of inspired Oxygen (FiO2) up to and including 60% at baseline (median FiO2) Primary Endpoint in mITT population has a nominal
Slide 14: Opaganib Benefit Across Key Secondary Endpoints
Opaganib Benefit Across Key-Secondary Endpoints in Subpopulation with Lower Oxygen Supplementation at Baseline (<=60% FiO2) Benefit observed across secondary endpoints with nominally significant p-values: Opaganib Placebo Parameter Statistics Outcome (N=117) (N=134) Patients With an Improvement of 2
Slide 15: Opaganib Mortality Benefit Consistent Across All Territories
Opaganib’s Mortality Benefit in Subpopulation with Lower Oxygen Supplementation at Baseline (FiO2 ≤60%) Consistent Across All Territories Mortality due to any cause at Day 42 in the subpopulation requiring ≤60% FiO2 at Baseline by Territory Opaganib Placebo Difference in Rates [%] Territory (N=117)
Slide 16: Analysis of Potential Confounders Supports Opaganib's Benefit
Analysis of Potential Confounders Supports Opaganib’s Benefit* Confounder Opaganib Placebo Difference Mortality Efficacy continuous noriskfactors 4.60% 11.20% -6.60% 59% Pooled Curr Age Group 1 4.60% 11.50% -6.80% 59% Age: </>median 4.60% 11.50% -6.90% 60% continuous age 4.50% 11.70% -7.20% 62% Card
Slide 17: Opaganib Global Phase 2/3 Study - Biomarkers Analysis
Opaganib Global Phase 2/3 Study - Biomarkers Analysis • Evaluation of baseline biomarkers supports the use of FiO2 as indicator of disease severity and as a predictor of the treatment benefit in the target population Biomarker medians by subpopulations (FiO2≤60% and FiO2>60% at baseline) Lower FiO2
Slide 18: Opaganib Global Phase 2/3 Study - Safety Analysis
Opaganib Global Phase 2/3 Study - Safety Analysis Safety events in this study were similar between treatment arms with no new safety concerns emerging • The majority of the TEAEs were mild to moderate in severity • Serious TEAEs were experienced by 52/230 (22.6%) patients in the opaganib arm versus
Slide 19: Opaganib Global Phase 2/3 Study - Post Hoc Analysis Perspective
Opaganib Global Phase 2/3 Study - Post Hoc Analysis Perspective ✓ FiO2 is a clinically and medically relevant parameter for capturing oxygen requirement & indicating disease severity – this conjecture is now also supported by known inflammatory biomarkers of disease severity Consistency of opaganib’
Slide 20: Opaganib Global Phase 2/3 Study - Regulatory Status
Opaganib Global Phase 2/3 Study - Regulatory Status • Data package filed in key territories worldwide – anticipating regulatory guidance for next steps in the targeted hospitalized COVID-19 patient population, where there is currently no effective treatment • EU (EMA) – has indicated rapid procedure
Slide 21: RHB-107 (upamostat)
RHB-107 (upamostat) Investigational new drug Novel orally administered, first-in-class small molecule targeting oncology, inflammatory lung diseases and GI indications Phase 2/3 COVID-19 ongoing in non-hospitalized patients in the U.S. and South Africa 21 21
Slide 22: RHB-107 - Phase 2/3 Study in Non-Hospitalized COVID-19 Patients
RHB-107 - Phase 2/3 Study in Non-Hospitalized COVID-19 Patients ✓ Phase 2/3 study in non-hospitalized patients with symptomatic COVID-19 ongoing in U.S. and South Africa ✓ Recruitment completed for part A of the study - Top-line data expected Q1/22 RHB-107 - Once-daily, orally-administered treatment
Slide 23: Additional R&D Programs Overview
Additional R&D Programs Overview Third Quarter 2021 Financial Results and Operational Highlights November 30, 2021 Guy Goldberg Chief Business Officer 23
Slide 24: RHB-204
RHB-204 Investigational new drug Targeting pulmonary nontuberculous Mycobacteria (NTM) disease - with Orphan Drug designation, QIDP designation, including Fast-Track development status U.S. Phase 3 Study Ongoing 24
Slide 25: RHB-204 - CleaR-MAC Phase 3 Study Ongoing
RHB-204 - CleaR-MAC Phase 3 Study Ongoing A Phase 3 study to assess RHB-204 as a first-line treatment for the treatment of pulmonary Mycobacterium avium Complex (MAC) disease in adults with nodular bronchiectasis Study Initiated - November 2020 - Multi-center, randomized, double-blind, two-part, pla
Slide 26: RHB-104
RHB-104 Investigational new drug Combination therapy targeting MAP bacteria for treatment of Crohn’s disease and potentially other autoimmune diseases Positive First Phase 3 Study in Crohn’s Disease - Study Successfully Met Its Primary Endpoint and Key Secondary Endpoints Potential Diagnostic Progre
Slide 27: RHB-104 MAP US Study in Crohn's Disease - Reminder Summary
RHB-104 MAP US Study in Crohn’s Disease - Reminder Summary The first global, double-blind placebo-controlled study to demonstrate the efficacy of anti-MAP therapy in Crohn’s disease • RHB-104 is a promising new class of treatment for Crohn’s disease • Demonstrated statistically significant benefit o
Slide 28: RHB-104 - Our Plans
RHB-104 - Our Plans Possible progress in MAP diagnostic technology may enable advancement towards a confirmatory study in MAP positive moderate-severe Crohn’s patients Planned confirmatory trial design, pending regulatory input: • Relatively small study in 100-150 MAP positive moderate-severe patien
Slide 29: Commercial Progress Q3/21
Commercial Progress Q3/21 Third Quarter 2021 Financial Results and Operational Highlights November 30, 2021 Rob Jackson Senior VP Sales & Marketing 29
Slide 30: Summary
Summary RedHill achieved record Q3/21 prescription volume 117% Talicia® growth over Q3/20 15% Q/Q growth for Talicia® and 1.1% for Movantik® in Q3/21 73% market share for Movantik® – maintaining market leadership in the PAMORA class RedHill anticipating a strong Q4/21 for both brands 30
Slide 31: Consecutive Quarterly Growth in Q2/21 and Q3/21
RedHill Delivered Consecutive Quarterly Growth in Q2/21 and Q3/21 Movantik Growth Factors: ✓ Market access successes Movantik nTRx Growth - All Channels with major payors 120,000 110,000 +5.6% +1.1% ✓ Focused RedHill execution 100,000 in Pain segment nTRx Volume 90,000 ✓ Favorable opioid 80,000 pres
Slide 32: Opioid Prescribing Volume is Stabilizing
Opioid Prescribing Volume, which is Highly Correlated with PAMORA Prescribing Volume, is Stabilizing Opioid Rx Volume 12-Month Moving Annual Total (MAT) 160,000,000 155,000,000 150,000,000 nTRx Volume 145,000,000 140,000,000 135,000,000 130,000,000 Opioid Rx Volume MAT Opioid Rx Volume Trend 32
Slide 33: U.S. PAMORA Market is Stabilizing and Showing Signs of Growth
The U.S. PAMORA Market is Stabilizing and Showing Signs of Growth* PAMORA Market Volume 12-Month Moving Annual Total (MAT) 555,000 550,000 545,000 nTRx Volume 540,000 535,000 530,000 525,000 520,000 Jul-20 Jul-21 Jun-20 Nov-19 Apr-20 May-20 Nov-20 Apr-21 May-21 Jun-21 Dec-19 Jan-20 Feb-20 Mar-20 Aug
Slide 34: Movantik Continues to Achieve New Milestones
Movantik Continues to Achieve New Milestones Over 2.5 million prescriptions since launch Nearly 90% of all insurance plans provide access for Movantik Q3/21 nNRx growth vs. Q3/20 Q3/21 Prescriber base +2% vs. Q3/20 34
Slide 35: Talicia Delivered 15% Prescription Growth in Q3/21
Talicia Delivered 15% Prescription Growth in Q3/21 Talicia nTRx Growth 2,000 1,800 1,600 Planned Field Starts 1,400 Launch Returning 1,200 nTRx Volume “Full” 1,000 Strength 800 600 COVID-19 400 Pullback 200 - Talicia continues to achieve new milestones with 15% Q/Q growth in Q3/21 and growing commer
Slide 36: RedHill Delivered 15% nTRx Growth for Talicia in Q3/21
RedHill Delivered 15% nTRx Growth for Talicia in Q3/21 Talicia Growth Initiatives: Talicia Growth 5,000 +15% ✓ Improving commercial 4,500 payor coverage supports 4,000 volume growth 3,500 nTRx Volume 3,000 2,500 ✓ Improving office access 2,000 enabling trial and usage 1,500 1,000 ✓ Improving field 5
Slide 37: Talicia Expanded Unrestricted Coverage in Medicaid
Talicia Expanded Unrestricted Coverage in Medicaid Talicia Lives Covered • In October, Talicia was included as a 80% preferred brand with no restrictions on the Medi-Cal (State of California) 70% 8 out of 10 lives contract drug list for 2M Fee-For- 60% 6 out of Service Medicaid lives 50% 10 lives 40
Slide 38: Talicia Continues to Achieve New Milestones
Talicia Continues to Achieve New Milestones Record Weekly, Monthly and Quarterly nTRx Volume Highest Level of Commercial (8/10) and Government (6/10) Coverage 117% nTRx Volume Growth Over Q3/2020 38
Slide 39: Aemcolo: Prepared for International Travel to Return
Aemcolo: Prepared for International Travel to Return % Aemcolo Commercial Lives Covered • Almost 50 million people 90% traveled from the U.S. to Mexico and the Caribbean in 80% 82% 2019 70% 60% • Travel decreased by more 64% 50% than half in 2020 due to 40% pandemic travel restrictions 30% and safet
Slide 40: Q4/21 - Commercial Outlook
Q4/21 - Commercial Outlook Continuous Improvement in Execution Established the Foundation for a Strong Q4/21 Movantik®: Focus on volume growth, market growth and additional payor wins Talicia®: >15% Q/Q growth in Q3/21; Anticipating accelerated new prescription and prescriber volume growth in Q4/21
Slide 41: Financials
Financials Third Quarter 2021 Financial Results and Operational Highlights November 30, 2021 Micha Ben Chorin Chief Financial Officer 41
Slide 42: Q3/2021 Financial Highlights (1/3)
Q3/2021 Financial Highlights (1/3) Record revenues and plan to be near commercial operational breakeven on a quarterly basis by end of 2021* • Cash position** of approximately $51.5 million as of September 30, 2021 • Post Q3/21 key financings: • Strategic investment in RedHill by South Korea’s Kukbo
Slide 43: Q3/2021 Financial Highlights (2/3)
Q3/2021 Financial Highlights (2/3) • Total operating expenses of $29.8 million in Q3/2021, a decrease of $6 million compared to Q2/2021 • Research and development expenses of $5.8 million, a decrease of $4.5 million compared to Q2/2021, mainly attributable to the completion of our global COVID-19 Ph
Slide 44: Q3/2021 Financial Highlights (3/3)
Q3/2021 Financial Highlights (3/3) • Operating Loss and Net Loss were $17.4 million and $21.4 million, respectively, compared to $24.9 million and $29.1 million, respectively, in Q2/2021. The decrease was mainly attributable to the Talicia® inventory expiration date extension, progress in our COVID-
Slide 45: Q&A
Q&A Third Quarter 2021 Financial Results and Operational Highlights November 30, 2021 Dror Ben-Asher Chief Executive Officer 45
Slide 46: Thank you
Thank you RedHill Biopharma Website: www.RedHillbio.com Email: info@redhillbio.com 46