RedHill Biopharma Ltd. · NASDAQ:RDHL
RedHill Biopharma — IPO Roadshow (March 2021)
35 slides from RedHill Biopharma's IPO roadshow presentation, Mar 1, 2021
Slide 1: RedHill Biopharma Ltd. Corporate Update March 2021
RedHill Biopharma Ltd. (“RDHL”)Corporate UpdateMarch 2021 Free Writing Prospectus dated March 1, 2021Filed pursuant to Rule 433Relating to the Preliminary Prospectus Supplement datedMarch 1, 2021Registration Statement No. 333-232777 RedHill Biopharma Ltd. (“RDHL”)Corporate UpdateFebruary 2021 Full c
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: Strong U.S. Commercial Footprint and Robust Development Pipeline
Strong U.S. Commercial Footprint and Robust Development Pipelinewith Multiple Near-Term Milestones Corporate Highlights An emerging U.S. specialty biopharmaceutical company (Nasdaq: RDHL), primarily focused on U.S. commercialization and development of drugs for gastrointestinal (GI) diseases and inf
Slide 4: Development Pipeline
Development Pipeline**** Pre-Clinical Phase 1/2 Phase 3 NDA RHB-204 NTM disease NTM infections RHB-104 Crohn’s disease RHB-102(Bekinda®) Gastroenteritis IBS-D RHB-106 Bowel cleanser Opaganib (Yeliva®) Oncology Indications + COVID-19 RHB-107 (upamostat) Oncology/GI + COVID-19 Commercial Products** Ta
Slide 5: Emerging U.S. Specialty Pharma: Select Programs
Mytesi® Donnatal®EnteraGam® RHB-204NTMOpaganib COVID-19RHB-107COVID-19 RHB-104Crohn’s diseaseOpaganibCholangiocarcinomaRHB-106Bowel preparationRHB-102GastroenteritisRHB-102IBS-D Opaganib GIRHB-107Oncology/GI *Presented events are forward looking statements and estimates and are subject to uncertaint
Slide 6: Financial Highlights
Financial Highlights* RedHill Biopharma Ltd.Nasdaq: RDHL Market Cap (approx.) $400 million American Depositary Shares (ADSs) 42.01 million(Representing 420,199,054 million ordinary shares outstanding) Cash Balance as of February 15, 2021** Approx. $66 million * Financial information as of February 2
Slide 7: Consistent Revenue Growth Despite Challenging Pandemic Conditions
Consistent Revenue Growth Despite Challenging Pandemic Conditions
Slide 8: Talicia Launch Update: Strong Script Month over Month Growth
Talicia Launch Update: Strong Script Month over Month Growth Encouraging launch trajectory even with restrictive pandemic conditions * nTRx Volume Talicia Monthly nTRx Growth* Talicia Launch * Data from IQVIA Xponent; nTRx (normalized TRx)** Historical prescription growth may not be indicative of fu
Slide 9: Positive Reimbursement: Talicia Commercial & Government Coverage
7 out of 10 commercially insured patients can access Talicia6 out of 10 patients are without restrictions Positive Reimbursement TaliciaCommercial & Government Coverage Commercial & Government Coverage * Movantik coverage has remained relatively constant to YE 2019. 9 out of 10 commercially insured
Slide 10: Highly Experienced Senior Leadership
Highly Experienced Senior Leadership Dror Ben-Asher, Chief Executive OfficerP.C.M.I. Ltd. Adi Frish, Chief Corporate & Business Development OfficerY. Ben-Dror, MediGus Micha Ben Chorin, Chief Financial OfficerGVT, Pyramid Analytics, Starhome B.V. Reza Fathi, PhD, Senior VP R&DXTL, PharmaGenics, Harv
Slide 11: Opaganib (ABC294640, Yeliva)
Opaganib (ABC294640, Yeliva®)*Investigational new drugFirst-in-class, orally-administered sphingosine kinase-2 (SK2) inhibitor targeting multiple oncology, inflammatory and GI indicationsOngoing global Phase 2/3 study and positive top-line data from U.S. Phase 2 study for COVID-19--Phase 2 study for
Slide 12: Opaganib: The Product
The Product Potential first-in-class, orally-administered sphingosine kinase-2 (SK2) inhibitor - with anti-cancer, anti-inflammatory activities, targeting multiple oncology, inflammatory and GI indicationsPotent anti-viral activity, targeting a critical host factor - minimizing potential development
Slide 13: Opaganib - Ongoing Phase 2/3 COVID-19 Study
Opaganib (Yeliva®) - Ongoing Phase 2/3 COVID-19 Study U.S. randomized, double-blind, placebo-controlled Phase 2 studyPositive top-line safety and efficacy dataSmall sample size of 40 hospitalized patients with COVID-19 pneumoniaFocused on safety and initial efficacy signals; not powered for statisti
Slide 14: Opaganib Phase 2 COVID-19 Study - Positive Top-Line Data
Opaganib Phase 2 COVID-19 Study - Positive Top-Line Data U.S. Phase 2 study of opaganib in patients hospitalized with COVID-19 pneumonia:Non-powered study of 40 patients, randomized 1:1 to received opaganib or placebo on top of standard-of-care. Follow up for up to 42 days post treatment initiationP
Slide 15: Opaganib - Complete Inhibition of SARS-CoV-2
Opaganib’s unique MoA combines potent antiviral and anti-inflammatory activities, targeting a host cell component and minimizing likelihood of resistance Opaganib (Yeliva®) - Complete Inhibition of SARS-CoV-2 Potent Anti-SARS-CoV-2 Activity: Opaganib evaluated in in vitro model of human lung bronchi
Slide 16: RHB-107 (upamostat)
RHB-107 (upamostat)Investigational new drugPotential first-in-class small molecule targeting oncology, inflammatory lung diseases and GI indicationsU.S. Phase 2/3 COVID-19 outpatient study ongoing 16
Slide 17: RHB-107 - S1 Serine Protease Inhibitor with Ongoing Phase 2/3 COVID-19 Outpatient Study
RHB-107 - S1 Serine Protease Inhibitor with Ongoing Phase 2/3 COVID-19 Outpatient Study 17 The Drug Potential first-in-class, orally-administered inhibitor of S1 family of trypsin-like serine proteases with potential for use in the treatment of cancer, inflammatory lung diseases, irritable bowel syn
Slide 18: RHB-107 - Ongoing Phase 2/3 COVID-19 Outpatient Study
RHB-107 - Ongoing Phase 2/3 COVID-19 Outpatient Study Study design: 310 patients to be enrolled in a 2-part, multicenter, randomized, double-blind, placebo-controlled, parallel-group Phase 2/3 studyInnovative use of home-based monitoring technologies with home nursing support allowing patients parti
Slide 19: Commercial Operations - Strong U.S. Presence
Commercial Operations - Strong U.S. Presence Launched Aemcolo® in Q4/2019, Talicia® in Q1/20 and promoting Movantik® since April 2020 Sales force of 100 reps + 30 field support professionals promoting 3 products to thousands of GI, PCPs and other HCPs *Movantik® is a registered trademark of AstraZen
Slide 20: Talicia - Approved by U.S. FDA for Treatment of H. pylori Infection
Talicia®- Approved by U.S. FDA for Treatment of H. pylori Infection in Adults Approved Indication Treatment of H. pylori infection in adults Drug Omeprazole magnesium, amoxicillin and rifabutin 10 mg*/ 250 mg/ 12.5 mg delayed-release capsules* Approved NDA approved by U.S. FDA in November 2019 - lau
Slide 21: H. pylori infection and progressive gastro-duodenal damage
H. pylori infection → Progressive gastro-duodenal damageH. pylori - a Group I carcinogen and the strongest risk factor for gastric cancer1 and peptic ulcer disease; Also associated with iron deficiency, B12 deficiency and drug malabsorptionGastric cancer - a leading cause of cancer mortality worldwi
Slide 22: Talicia - Potential First-Line Therapy Targeting up to $1.4B U.S. Market
Talicia®- Potential First-Line Therapy Targeting up to $1.4B U.S. MarketEfficacy - demonstrated clinical activity with high statistical significance in eradicating H. pylori in U.S. pivotal Phase 3 studyAddresses concerns of resistance to clarithromycin and metronidazoleAttractive tolerability profi
Slide 23: Movantik - FDA-Approved for Treatment of Opioid-Induced Constipation
Movantik®- FDA-Approved for Treatment of Opioid-Induced Constipation Approved Indication Treatment of opioid-induced constipation (OIC) in adults with chronic non-cancer pain Drug Oral naloxegol tablets available in 12.5mg and 25mg dosage strengths Approved Approved in the U.S. in 2014 - launched in
Slide 24: OIC is a Large and Underserved Market
OIC is a Large and Underserved Market* 50 million U.S. adults with chronic pain**** 15 million U.S. patients with chronic painare prescribed opioids*** 6.2 – 12.4**million opioid users in theU.S. may have OIC* 71% of patients with OIC report little to no benefit from constipation treatments*** *Bell
Slide 25: Movantik - the #1 Prescribed Oral PAMORA
Movantik - the #1 Prescribed Oral PAMORA* The #1 prescribed oral PAMORA specifically designed to treat OIC** Over 2,000,000 prescriptions written since 2015** Movantik is covered or preferred without prior authorization for the majority of commercial and Medicare Part D patients in the U.S.**** The
Slide 26: Aemcolo
Launched by RedHill in the U.S. - December 2019A rifamycin antibacterial approved by U.S. FDA in Nov. 2018 for the treatment of travelers’ diarrhea caused by noninvasive strains of E. coli in adultsIn-licensed U.S. rights from Cosmo Pharmaceuticals N.V. in Oct. 2019Robust U.S. patent portfolio and F
Slide 27: RHB-204 Targeting Pulmonary NTM Disease
RHB-204Investigational new drugTargeting pulmonary nontuberculous Mycobacteria (NTM) disease - with QIDP designation, including Fast-Track development statusU.S. Phase 3 Study Initiated
Slide 28: RHB-204 Planned Indication and Product
Planned Indication Pulmonary nontuberculous mycobacteria disease (NTM) caused by MAC infection The Product Patent-protected, oral all-in-one combination of three antibiotic drugs (clarithromycin, clofazimine and rifabutin) each known to be active against NTM disease caused by MAC* Key Attributes Tar
Slide 29: RHB-204 for Pulmonary NTM - Background and Epidemiology
RHB-204 for Pulmonary NTM - Background and Epidemiology 29 1 Wassilew et al, RESPIRATION 2016 2 Griffith DE, et al. An official ATS/IDSA statement: diagnosis, treatment, and prevention of nontuberculous mycobacterial diseases Am J Respir Crit Care Med. 2007;175(4):367-416; 3 American Thoracic Societ
Slide 30: RHB-204 - Phase 3 Study Initiated
A Phase 3 study to assess the efficacy and safety of RHB-204 as a first-line treatment of pulmonary nontuberculous mycobacteria (NTM) disease caused by Mycobacterium avium complex (MAC) Study Initiated November 2020 Study Design Multi-center, randomized, double-blind, two-part, placebo-controlled, p
Slide 31: RHB-104 Crohn's Disease
RHB-104Investigational new drugCombination therapy targeting MAP bacteria for treatment of Crohn’s disease and potentially other autoimmune diseasesPositive First Phase 3 Study in Crohn’s Disease - Study Successfully Met Its Primary Endpoint and Key Secondary Endpoints
Slide 32: The Link between Crohn's Disease and MAP
The Link between Crohn’s Disease and MAP MAP (mycobacterium avium subsp. paratuberculosis) is the causative agent of Johne’s disease, an infectious disease in cattle, clinically and pathologically similar to Crohn’s diseaseAn intracellular pathogen that proliferates in monocytes/macrophagesExtremely
Slide 33: RHB-104 for Crohn's - Product and Market Overview
RHB-104 for Crohn’s - Product and Market Overview Planned Indication Treatment of Crohn’s disease in adult patients The product Patent-protected combination of 3 antibiotics (clarithromycin, clofazimine and rifabutin) in a single oral capsule with potent intracellular, antimycobacterial and anti-inf
Slide 34: Phase 3 MAP US Study
Multi-center, randomized, double-blind, placebo-controlled, parallel group study (MAP US study) to assess efficacy and safety of orally-administered, fixed-dose combination RHB-104 in subjects with moderately to severely active Crohn’s disease, on-top of baseline background SoC medications Number of
Slide 35: Thank You!
RedHill Biopharma Ltd.21 Ha’arba’a St. Tel-Aviv, 6473921, Israel Email: info@redhillbio.comTel: +972-3-541-3131 35 Thank You!