Brepocitinib Overview & RVT-3101 Update

Made public by

sourced by PitchSend

1 of 31

Creator

Roivant logo
Roivant

Category

Technology

Published

1H 2023

Slides

Transcriptions

#1Roivant Overview J.P. Morgan Healthcare Conference January 9, 2023 roivant#2Forward-Looking Statements Forward-Looking Statements This presentation includes forward-looking statements that are subject to substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. All statements other than statements of historical facts contained in this presentation, including statements regarding our future results of operations and financial position, business strategy, research and development plans, the anticipated timing, costs, design and conduct of our ongoing and planned preclinical studies and clinical trials for our products and product candidates, including the information presented in this presentation with respect to RVT-3101 and the potential for RVT-3101 to improve the treatment of Ulcerative Colitis (UC) and Crohn's Disease (CD) and to be a first-in-class agent, any commercial potential of our product candidates and the receipt of proceeds from the expected sale of the Myovant top-up shares to Sumitomo Pharma, are forward-looking statements. These forward-looking statements are based upon the current expectations and beliefs of our management as of the date of this presentation, and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Although we believe that our plans, intentions, expectations and strategies as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements. The interim data presented here for RVT-3101 is from the induction period of the TUSCANY-2 study and is based on an interim analysis of key efficacy and safety data, and such data may change following completion of the clinical trial and may not accurately reflect the complete results of the TUSCANY-2 study. Although we believe that our plans, intentions, expectations and strategies as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a number of risks, uncertainties and assumptions, including, but not limited to, those risks set forth in the sections captioned "Risk Factors" and "Forward-Looking Statements" of our filings with the U.S. Securities and Exchange Commission, available at www.sec.gov and investor.roivant.com. We operate in a very competitive and rapidly changing environment in which new risks emerge from time to time. These forward-looking statements are based upon the current expectations and beliefs of our management as of the date of this presentation, and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Except as required by applicable law, we assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise. This presentation includes data, results and attributes for RVT-3101 and certain other products and product candidates generated from separate, independent studies and that do not come from head-to-head analysis. Differences exist between study or trial designs and subject characteristics and caution should be exercised when comparing data across studies. Data regarding other products and product candidates is based on publicly available information. Disclaimer Today's discussions and presentation are intended for the investor community only; they are not intended to promote the product candidates referenced herein or otherwise influence healthcare prescribing decisions. roivant For investor audiences only 2#32022 Has Been an Incredible Year for Roivant ... Commercial Launch of VTAMA Became #1 most prescribed branded topical for psoriasis 8 weeks into launch Executed first major PBM/payer contract Japanese partner reported positive topline results in Phase 3 trial in AD Demonstrated favorable PK and safety in pediatric subjects with AD Pipeline Composition RVT-3101 and brepocitinib: ☐ Announced collaborations with Pfizer IMVT-1402: Unveiled next- generation anti-FcRn Batoclimab: Announced new indications Optimized pipeline and extended runway by discontinuing six programs n Clinical Progress Brepocitinib: Initiated Phase 3 trial in DM Brepocitinib: Completed enrollment in global Phase 2B trial in SLE Namilumab: Initiated Phase 2 trial in sarcoidosis RVT-2001: Expanded ongoing Phase 1/2 trial in lower-risk MDS Batoclimab: Initiated Phase 3 trials in MG and TED Additional Upside Established multiple partnerships in targeted protein degradation with aggregate milestone payments over $1B plus product royalties roivant ли LNP patent litigation progressed in Roivant's favor For investor audiences only 3#4... In Which We Built an Industry-Leading 2023 Catalyst Calendar JPM 2022 Program Catalyst JPM 2023 Expected Timing Program Catalyst Expected Timing RVT-3101 Induction data from Phase 2B trial in ulcerative colitis 1Q 2023 VTAMA (tapinarof) Topline data from Phase 3 1H 2023 VTAMA (tapinarof) trials in atopic dermatitis Topline data from Phase 3 trials in atopic dermatitis 1H 2023 cream cream roivant RVT-3101 Final data including chronic therapy period from Phase 2B trial in ulcerative colitis 1H 2023 IMVT-1402 Initial data from Phase 1 trial Mid 2023 Brepocitinib Topline data from potentially registrational Phase 2B trial in systemic lupus erythematosus 2H 2023 4 For investor audiences only#5Roivant Pipeline VTAMA / Psoriasis | Dermavant (tapinarof) cream 1% VTAMA/Atopic Dermatitis | Dermavant (tapinarof) cream 1% RVT-3101 Ulcerative Colitis | New Vant RVT-3101 Crohn's Diseases | New Vant BREPOCITINIB Dermatomyositis | Priovant BREPOCITINIB Systemic Lupus Erythematosus | Priovant BREPOCITINIB Other Indications | Priovant A BATOCLIMAB Myasthenia Gravis | Immunovant Y BATOCLIMAB Thyroid Eye Disease | Immunovant BATOCLIMAB Chronic Inflammatory Demyelinating Polyneuropathy | Immunovant Y BATOCLIMAB Graves' Disease | Immunovant A BATOCLIMAB Warm Autoimmune Hemolytic Anemia | Immunovant Y IMVT-1402 Numerous Indications | Immunovant n NAMILUMAB Sarcoidosis | Kinevant RVT-2001 Transfusion-Dependent Anemia in Patients with Lower-Risk MDS | Hemavant roivant Pipeline reflects both ongoing clinical trials and expected upcoming trials. VTAMA has only received FDA approval for psoriasis, not atopic dermatitis. Modality Preclinical Phase 1 Phase 2 Phase 3 Approved Topical Topical Biologic Biologic Small Molecule Small Molecule Small Molecule Biologic Biologic Biologic Biologic Biologic Biologic Biologic Small Molecule Represents registrational or potentially registrational trials For investor audiences only 5#6Roivant Has Potential Category Winners in 5 out of 7 Leading I&I Markets and is in Multiple Interesting Growth Areas as Well 2028 Top US I&I Markets¹ Additional Growth Markets Psoriasis $22.3 billion CIDP ~16K US Patients Atopic Dermatitis $12.2 billion Myasthenia Gravis ~59K US Cases Crohn's Disease $9.3 billion Thyroid Eye Disease ~15-20K New US Cases/Year Ulcerative Colitis $6.9 billion Graves' Disease ~116K US Incident Pop. SLE $3.8 billion Dermatomyositis ~37K US Adults Rheumatoid Arthritis $10.2 billion Psoriatic Arthritis $3.9 billion roivant Indications with active development programs Other than VTAMA in psoriasis, drugs are investigational and subject to regulatory approval. 1. Source: Evaluate Pharma. Other indications 6 For investor audiences only#7RVT-3101 VTAMA! Psoriasis | Dermavant (tapinarof) cream 1% ✓✓ Atopic Dermatitis | Dermavant VTAMA (tapinarof) cream 1% RVT-3101 Ulcerative Colitis | New Vant RVT-3101 Crohn's Diseases | New Vant BREPOCITINIB Dermatomyositis | Priovant BREPOCITINIB Systemic Lupus Erythematosus | Priovant BREPOCITINIB Other Indications | Priovant Y BATOCLIMAB Myasthenia Gravis | Immunovant Modality Preclinical Phase 1 Phase 2 Phase 3 Approved Topical Topical Biologic Biologic Small Molecule Small Molecule Small Molecule Biologic Biologic BATOCLIMAB Thyroid Eye Disease | Immunovant BATOCLIMAB Chronic Inflammatory Demyelinating Polyneuropathy | Immunovant Biologic др BATOCLIMAB Graves' Disease | Immunovant Biologic Y BATOCLIMAB Warm Autoimmune Hemolytic Anemia | Immunovant Biologic IMVT-1402 Numerous Indications | Immunovant Biologic n NAMILUMAB Sarcoidosis | Kinevant Biologic RVT-2001 Transfusion-Dependent Anemia in Patients with Lower-Risk MDS | Hemavant roivant Pipeline reflects both ongoing clinical trials and expected upcoming trials. VTAMA has only received FDA approval for psoriasis, not atopic dermatitis. Small Molecule A A A A A Represents registrational or potentially registrational trials For investor audiences only 7#8RVT-3101: A Phase 3-Ready Anti-TLIA Antibody for Ulcerative Colitis, Crohn's Disease and Other Indications Statistically Significant and Clinically Meaningful Effects Seen in UC Phase 2b • • High-end efficacy in all-comers population, statistically significant and clinically meaningful benefit at all doses tested Response rates enriched in patients positive for a prospectively defined biomarker (~60% of UC patients) Favorable safety and tolerability profile Large and Well-Validated Market Opportunity RVT-3101 is First-in-class with Large Data Set in Hand Additional Near-Term Catalyst • • • • . Both ulcerative colitis and Crohn's disease are large, well-validated commercial markets Additional value creation potential expected outside of IBD Robust dose ranging work to date: ~300 patients across four dose arms and two studies (including with SQ formulation) Efficient Phase 3 program planned with clearly defined path to approval Final UC Phase 2b data (TUSCANY-2) expected 1H 2023 Strong Intellectual Property Position • • Composition of matter IP protection until 2039+ (including extensions) Biologic confers 12 years of regulatory exclusivity following approval roivant For investor audiences only 8#9RVT-3101 Shows Consistent Effect Across Endpoints and Patient Populations Results were statistically significant for pooled drug and at each individual dose tested Clinical Remission (Modified Mayo) RVT-3101 Placebo Endoscopic Improvement ■RVT-3101 Placebo 45% 65% 40% Pbo-adj A = 27% p = 0.02 60% Pbo-adj A = 41% 55% Pbo-adj A = 21% p = 0.002 35% p = 0.01 37% 50% 45% Pbo-adj A = 21% 51% 30% 32% p = 0.01 40% 25% 35% 40% 30% 20% 25% 15% 20% 10% 12% 15% 19% 10% 10% 5% 10% 5% 0% 0% All-Comers Pooled Biomarker Positive Pooled All-Comers Pooled Biomarker Positive Pooled • roivant In -20% of patients across the study, biomarker was not analyzed due to lack of consent at specific sites • Among patients for whom biomarker status was analyzed, biomarker positive or negative status was determined in 100% of patients One-sided p-value of difference of proportions were computed using Chan And Zhang (1999) method, in accordance with Pfizer prespecified statistical analysis plan. Statistical significance considered to be a p-value ≤ 0.025. Values that are not significant are marked "NS" Placebo-adjusted delta values may not exactly match the difference between gross and placebo values due to rounding. For investor audiences only 9#10Expected Phase 3 Dose Shows Clinically Meaningful Improvements in Biomarker Positive Patients Beyond Those Seen in the Overall Population Clinical Remission (Modified Mayo) Endoscopic Improvement ■RVT-3101 Placebo RVT-3101 Placebo 45% Pbo-adj A 30% p = 0.02 65% 60% 40% 55% 35% Pbo-adj A 20% p = 0.01 40% Pbo-adj A = 46% p = 0.0005 56% 50% Pbo-adj A = 22% 45% 30% p = 0.01 31% 40% 25% 40% 35% 30% 20% 25% 15% 20% 10% 12% 15% 19% 10% 10% 5% 10% 5% 0% 0% All-Comers Biomarker Positive All-Comers Expected P3 Dose Expected P3 Dose Expected P3 Dose Biomarker Positive Expected P3 Dose roivant 10 For investor audiences only#11Consistent Data Supports Highly Compelling Clinical Activity for TLIA Class 45% 40% 35% Clinical Remission (Modified Mayo) ■RVT-3101 Placebo ■Comparator Pbo-adj A = 30% p = 0.02 40% Pbo-adj A 20% = p = 0.01 30% 31% 25% 20% 15% 10% 12% 10% 5% 0% All-Comers Expected P3 Dose Biomarker Positive Expected P3 Dose Placebo Endoscopic Improvement ■RVT-3101 Placebo ■Comparator Placebo 65% 60% Pbo-adj A = 46% p = 0.0005 55% 56% 50% Pbo-adj A=22% 45% p = 0.01 Pbo-adj A 25% 40% 40% 26% 35% 30% 25% 20% 15% 19% 10% 10% 1% 5% 0% PRAO23 All-Comers Expected P3 Dose Biomarker Positive Expected P3 Dose Pbo-adj A 31% 37% PRAO23 6% Figures reflect cross-trial comparison and not results from a head-to-head study. Differences exist between trial designs and subject characteristics, and caution should be exercised when comparing data across studies. • roivant Clinical Remission reported for RVT-3101 requires stool frequency ≤ 1 and 21 point reduction from baseline, rectal bleeding frequency = 0, and endoscopic score ≤ 1 Clinical Remission reported for PRA023 requires stool frequency ≤1 and 20 point reduction from baseline, rectal bleeding frequency = 0, and endoscopic score ≤ 1 11 For investor audiences only#12RVT-3101 Offers Transformative Potential in Biologic-Experienced Patients who are Biomarker Positive Clinical Remission (Modified Mayo) in Biologic-Experienced Patients ■RVT-3101 Placebo ■Comparator Placebo Endoscopic Improvement in Biologic-Experienced Patients ■RVT-3101 Placebo ■Comparator Placebo. 45% Pbo-adj A = 41% 40% p = 0.03, NS 35% 41% 30% Pbo-adj A =22% 25% 24% 20% 15% 10% 5% 0% 0% Biomarker Positive Expected P3 Dose Rinvoq 1% 65% Pbo-adj A =56% 60% p = 0.005 55% 56% 50% 45% 40% 35% Pbo-adj A=29% 30% 32% 25% Pbo-adj A 11% Pbo-adj A9% 20% Pbo-adj A = 5% 13% 15% 12% 10% 10% 2% 3% 5% 5% 0% 0% Stelara Zeposia mirikizumab Biomarker Positive Expected P3 Dose Rinvoq Pbo-adj A 14% 21% Pbo-adj A 10% 15% 3% 7% Not Reported 5% Stelara Zeposia mirikizumab Figures reflect cross-trial comparison and not results from a head-to-head study. Differences exist between trial designs and subject characteristics, and caution should be exercised when comparing data across studies. Data for comparators come from respective Phase 3 studies except for mirikizumab where Phase 2 data are presented (biologic-experienced subset not reported in Phase 3) • roivant Clinical Remission reported for RVT-3101 requires stool frequency ≤ 1 and 21 point reduction from baseline, rectal bleeding frequency = 0, and endoscopic score ≤ 1 • • Clinical Remission reported for Rinvoq requires stool frequency ≤1 and 20 point reduction from baseline, rectal bleeding frequency = 0, and endoscopic score ≤ 1 Clinical Remission reported for Stelara requires stool frequency ≤ 3, rectal bleeding frequency = 0, and endoscopic score ≤ 1 For RVT-3101, some biologic experienced patients had also received a JAK inhibitor. Rinvoq data exclude patients with prior JAK exposure and reflect weighted average across the two Phase 3 studies. Mirikizumab data reflect weighted average of 200mg/600mg dose groups in their Phase 2 study. 12 For investor audiences only#13RVT-3101 Was Well-Tolerated With No Safety Signals Identified in Ongoing Phase 2b Study Pbo N = 45 Pooled N = 200 Expected Ph3 Dose Participants with AEs Participants with severe AES Participants with serious AEs 56% 45% 53% 7% 2% 2% 7% 4% 3% Participants discontinued study due to AEs 0% 0% 0% Participants discontinued study drug due to AEs 4% 1% 1% Participants with dose reduced or temporary discontinuation due to AEs Deaths 0% 0% 0% 0% 0% 0% Most Common AEs / AEs of Interest Infection and Infestations 9% 10% 9% Anemia 9% 4% 2% Injection Site Reaction COVID-19 2% 5% 5% 2% 1% 1% • • • The most common treatment emergent AEs were infections, anemia and injection site reactions, which were balanced across arms There were no dose-related trends for AEs; severe and serious AEs were sporadic and generally considered not related to drug No impact of immunogenicity on clinical efficacy or safety results ADA rate of 46% and neutralizing antibody rate of 8% at expected Phase 3 dose O Immunogenicity results in-line with approved biologics* Humira showed ADA rates of 32 - 46% and neutralizing antibody rates of 11 - 23% at week 241 - Skyrizi showed ADA rates of 19% and neutralizing antibody rates of 8% at week 162 roivant Reflects interim results from induction period of study (through week 14). If a given patient had more than one occurrence in the same event category, only the most severe occurrence was counted. Patients were only counted once per treatment per event. *Based on published data. No head-to-head studies were performed with approved biologics. 1. Hanauer et al 2021; Weinblatt et al 2017; Cohen et al 2019 2. Skyrizi (risankizumab) FDA Summary Basis of Approval 13 For investor audiences only#14RVT-3101 Shows High-End Efficacy Results in TUSCANY-2 Statistically significant and clinically meaningful efficacy results observed at every dose tested and in both overall and biomarker positive populations Overall Population At Expected P3 Dose Biomarker Positive Population* At Expected P3 Dose Clinical Remission Endoscopic Improvement 31% 40% 40% 41% for biologic-experienced 56% 56% for biologic-experienced Well-tolerated with no dose-related trends in AEs and no impact of immunogenicity on clinical efficacy or safety results roivant * A single, prospectively defined biomarker was used in the study and was the same biomarker used in the Phase 2a study 14 For investor audiences only#15VTAMA (tapinarof) VTAMA! Psoriasis | Dermavant (tapinarof) cream 1% VTAMA/Atopic Dermatitis | Dermavant (tapinarof) cream 1% RVT-3101 Ulcerative Colitis | New Vant RVT-3101 Crohn's Diseases | New Vant BREPOCITINIB Dermatomyositis | Priovant BREPOCITINIB Systemic Lupus Erythematosus | Priovant Modality Preclinical Phase 1 Topical Topical Biologic Biologic Small Molecule Small Molecule BREPOCITINIB Other Indications | Priovant Small Molecule BATOCLIMAB Myasthenia Gravis | Immunovant Y BATOCLIMAB Thyroid Eye Disease | Immunovant Biologic Biologic BATOCLIMAB Chronic Inflammatory Demyelinating Polyneuropathy | Immunovant Biologic др BATOCLIMAB Graves' Disease | Immunovant Biologic BATOCLIMAB Warm Autoimmune Hemolytic Anemia | Immunovant Biologic Y IMVT-1402 Numerous Indications | Immunovant Biologic n NAMILUMAB Sarcoidosis | Kinevant Biologic RVT-2001 Transfusion-Dependent Anemia in Patients with Lower-Risk MDS | Hemavant roivant Pipeline reflects both ongoing clinical trials and expected upcoming trials. VTAMA has only received FDA approval for psoriasis, not atopic dermatitis. Small Molecule Phase 2 Phase 3 Approved A A A A A Represents registrational or potentially registrational trials 15 For investor audiences only#16VTAMA Leads the Other Branded Topicals in Weekly TRX VTAMA Became the #1 Most Prescribed Branded Topical for Psoriasis 8 Weeks into Launch PsO Branded Topical Market - Weekly TRxs¹ 4,500 4,000 3,500 3,000 2,500 2,000 1,500 1,000 500 1/7 1/21 roivant 2/4 VTAMA (tapinarof) cream 1% ZZORYVE™ (roflumilast) cream 0.3% Source: IQVIA National Prescription Audit (NPA). 2/18 3/4 3/18 4/1 4/15 4/29 WYNZORA 5/13 5/27 6/10 ENSTILAR 6/24 7/8 ⚫DUOBRII 7/22 8/5 8/19 BRYHALI 9/2 9/16 ⚫LEXETTE 9/30 10/14 ⚫SORILUX 10/28 11/11 11/25 SOTYKTU 12/9 12/23 VTAMA AMA (tapinarof) cream 1% ENSTILAR ZZZ ZORYVE™ (roflumilast) cream 0.3% WYNZORA DUOBRII LEXETTE BRYHALI SORILUX SOTKYTU 16 For investor audiences only#17First Major PBM/Payer Contract Signed Initial contract provides national template for unrestricted access to VTAMA, setting it up to become the mainstay of topical treatment Effective date: October 1, 2022 Unrestricted access requiring only automatic lookback for a steroid or physician e-attestation of prior steroid use 87% of psoriasis patients use a topical steroid first line¹ $0 copay for covered claims with MyVTAMA savings card roivant 1. Analysis of Symphony Health claims data of patients diagnosed with PsO from February 2018 to January 2019 and tracked through February 2021 Dosing and Administration Apply VTAMA once a day to affected areas. Use exactly as your doctor tells you to and wash your hands after application (unless the treatment is on your hands). For questions about how to apply, patients can visit VTAMA.com/patient-experience for a video on the correct application process. About VTAMA (tapinarof) cream 1% VTAMA Cream is a steroid-free prescription medicine for adults with plaque psoriasis. It is not known if VTAMA Cream is safe and effective in children. Scan to watch our video guide to administering VTAMA VTAMA IMPORTANT SAFETY INFO Imwer instala sit need, muralesa mápacing wit, a wi tempor inciele ant ut labore et delers megre aliqus ut saer od minn veniam cu nestrud exercitatier torace laboris nisl ut a veteras slum delers sa hug at nala perstar. Excepteur sint scent 17 For investor audiences only#18Phase 3 Atopic Dermatitis ADORING Program - Study Design Two identically-designed pivotal trials followed by long-term, open-label extension ADORING Study Design Double-blind Treatment (8 weeks) Tapinarof 1% QD Long-term Open Label Extension (48 weeks) Patients with AD ➤ Ages 2 years & above (max 20% 18 years) ➤IGA score ≥ 3 BSA ≥ 5% - 35% EASI score > 6 (N=400 per pivotal study) ADORING 1 (DMVT 3101) R 2:1 ADORING 3 Vehicle QD Tapinarof 1% QD Long-term Extension (LTE) (DMVT 3103) Withdrawal & Re-treatment ADORING 2 R 2:1 (DMVT 3102) roivant Vehicle QD Primary endpoint: › Proportion of subjects who have a vIGA-ADTM O or 1 Baseline at Week 8 Secondary endpoints: › Proportion of subjects with EASI 75 @ week 8 › Mean change in %BSA from Baseline at Week 8 › Proportion of subjects with EASI 90 @ Week 8 › Proportion of subjects with > 4-pt reduction in PP-NRS @ Week 8 • Follow- Up (7 Days) Off- Treatment Enrollment Update ADORING 1 & 2 enrollment remains on track with data expected 1H 2023 • There is strong patient and investigator enthusiasm for the ADORING 3 long-term extension study 18 For investor audiences only#19Efficacy Data from a Phase 2b, Randomized Clinical Trial of Tapinarof Cream for the Treatment of Atopic Dermatitis Response rates: 49% of patients achieved IGA response and 51% of patients achieved EASI75 response at week 8 IGA Score 0 or 1 and ≥2-Grade Improvement at Week 8 Primary Endpoint was at 12 Weeks: Assessed in ITT Population EASI75 at Week 8 Secondary Endpoint was at 12 Weeks: Assessed in ITT Proportion of Patients (NRI Analysis) 60% Tapinarof 1% BID (n=40) Tapinarof 1% QD (n=41) -Tapinarof 0.5% BID (n=43) 50% Tapinarof 0.5% QD (n=41) Vehicle BID (n=42) 40% Vehicle QD (n=40) 30% 20% 10% Population (NRI Analysis) 70% -Tapinarof 1% BID (n=40) Week 8 * Tapinarof 1% QD (n=41) 49% * 60% Tapinarof 0.5% BID (n=43) Tapinarof 0.5% QD (n=41) * 13% Proportion of Patients 50% Vehicle BID (n=42) Vehicle QD (n=40) 40% 30% 20% 10% Week 8 51% 18% 0% 0% Week 1 Week 2 Week 4 Week 8 Week 12 Week 1 Week 2 Week 4 Week 8 Week 12 Japanese partner has also reported positive topline IGA and EASI75 results in Phase 3 trial for tapinarof in AD roivant 19 *Difference vs vehicle is statistically significant at p-value of 0.05 or lower. NRI analysis to account for higher dropout rates in vehicle group. BID, twice daily; IGA, Investigator Global Assessment; EASI, Eczema Area and Severity Index; ITT, intention to treat; NRI, non-responder imputation; QD, once daily. For investor audiences only#20VTAMA Is Just Getting Started Penetrating 400,000+ TRX Weekly Topical Market' Psoriasis and Atopic Dermatitis Total Market - Weekly TRX2 Psoriasis 600,000 VTAMA approved indication 500,000 400,000 300,000 200,000 100,000 3,922 VTAMA (tapinarof) cream 1% 65,703 161,487 91,862 Topicals Atopic Dermatitis VTAMA Phase 3 data expected 1H 2023 Total 35,825 356,749 518,236 320,924 Systemics Total Topicals Systemics Total Grand Total roivant 1. VTAMA has only received FDA approval for psoriasis, not atopic dermatitis. 2. Source: IQVIA National Prescription Audit (NPA). Market data as of week ending 09/16/2022. VTAMA TRX as of 12/23/2022. Psoriasis market weekly TRxs factored at the product level using ICD-10 code claim analytics. Topical Steroid Other Topical Biologic Oral 20 20 For investor audiences only#21Batoclimab and IMVT-1402 VTAMA! Psoriasis | Dermavant (tapinarof) cream 1% ✓✓ Atopic Dermatitis | Dermavant VTAMA (tapinarof) cream 1% RVT-3101 Ulcerative Colitis | New Vant RVT-3101 Crohn's Diseases | New Vant BREPOCITINIB Dermatomyositis | Priovant BREPOCITINIB Systemic Lupus Erythematosus | Priovant BREPOCITINIB Other Indications | Priovant Y BATOCLIMAB Myasthenia Gravis | Immunovant Modality Preclinical Phase 1 Phase 2 Phase 3 Approved Topical Topical Biologic Biologic Small Molecule Small Molecule Small Molecule Biologic Y BATOCLIMAB Thyroid Eye Disease | Immunovant Y BATOCLIMAB Chronic Inflammatory Demyelinating Polyneuropathy | Immunovant A A Y BATOCLIMAB Graves' Disease | Immunovant BATOCLIMAB Warm Autoimmune Hemolytic Anemia | Immunovant IMVT-1402 Numerous Indications | Immunovant n NAMILUMAB Sarcoidosis | Kinevant RVT-2001 Transfusion-Dependent Anemia in Patients with Lower-Risk MDS | Hemavant roivant Pipeline reflects both ongoing clinical trials and expected upcoming trials. VTAMA has only received FDA approval for psoriasis, not atopic dermatitis. Biologic Biologic Biologic Biologic Biologic Biologic Small Molecule A Represents registrational or potentially registrational trials 21 For investor audiences only#22Anti-FcRn Franchise Overview + $2 Batoclimab ༤༥༽. ༩༦ + + + + IMVT-1402 ༽༩ + + + + + roivant 1. Potential outcomes if Phase 1 results are as predicted by pre-clinical studies in cynomolgus monkeys Tailored dosing to address varying symptom severity across indications and stage of disease Short term maximal IgG suppression • Lower chronic doses where less IgG suppression needed • Fixed duration dosing in certain conditions Multiple pivotal trials ongoing in MG, TED and CIDP Chronic dosing to address symptom severity and duration for extended periods of time (>12 weeks)1 • • Sustained maximal IgG suppression where needed Chronic delivery with simple subcutaneous delivery in seconds No or minimal impact to albumin / LDL Pivotal-enabling catalyst in 2023: IMVT-1402 initial Phase 1 data expected in mid-2023 22 22 For investor audiences only#23IMVT-1402 is designed to deliver maximum IgG reduction while minimizing impact to LDL levels Albumin IgG concentration (mg/mL), mean percent change from baseline ± SD 100 Similar, maximum IgG reduction as batoclimab 50 -50 Batoclimab 60 FcRn Batoclimab Albumin IMVT-1402: Head-to-Head Monkey Study Albumin concentration (g/L), mean ± SD Similar albumin impact as placebo 50 I = 干[ H 40 30 6 ULN 5 4 3 LLN 2 20 -100 ↑ 1 10 0 7 14 21 28 35 42 56 -12 7 14 21 28 35 42 49 56 Day Day roivant Batoclimab 50 mg/kg (n=3) IMVT-1402 50 mg/kg (n=7) 1 Cholesterol concentration (mmol/L), mean ± SD Similar cholesterol impact as placebo IMVT-1402 3 FcRn IMVT-1402 LDL concentration (mmol/L), mean ± SD Similar LDL impact as placebo I H 1 01 1 t -12 7 14 21 28 35 42 49 56 -12 7 14 21 28 35 42 49 56 Day Day IMVT-1402 5 mg/kg (n=7) Placebo (n=3) Dose administration 23 Note: Ribbon representations generated from X-Ray crystal structure. Batoclimab solved at 2.4Å resolution. IMVT-1402 solved at 2.6Å resolution. For investor audiences only#24Brepocitinib VTAMA Psoriasis | Dermavant (tapinarof) cream 1% ✓✓ Atopic Dermatitis | Dermavant VTAMA (tapinarof) cream 1% RVT-3101 Ulcerative Colitis | New Vant RVT-3101 Crohn's Diseases | New Vant BREPOCITINIB Dermatomyositis | Priovant BREPOCITINIB Systemic Lupus Erythematosus | Priovant Modality Preclinical Phase 1 Phase 2 Phase 3 Approved Topical Topical Biologic Biologic Small Molecule Small Molecule BREPOCITINIB Other Indications | Priovant Small Molecule Y BATOCLIMAB Myasthenia Gravis | Immunovant Biologic BATOCLIMAB Thyroid Eye Disease | Immunovant Biologic BATOCLIMAB Chronic Inflammatory Demyelinating Polyneuropathy | Immunovant Biologic др BATOCLIMAB Graves' Disease | Immunovant Biologic Y BATOCLIMAB Warm Autoimmune Hemolytic Anemia | Immunovant Biologic Y IMVT-1402 Numerous Indications | Immunovant Biologic n NAMILUMAB Sarcoidosis | Kinevant Biologic RVT-2001 Transfusion-Dependent Anemia in Patients with Lower-Risk MDS | Hemavant roivant Pipeline reflects both ongoing clinical trials and expected upcoming trials. VTAMA has only received FDA approval for psoriasis, not atopic dermatitis. Small Molecule A Represents registrational or potentially registrational trials 24 24 For investor audiences only#25Brepocitinib Overview First-in-class dual TYK2/JAK1 inhibitor being developed for specialty autoimmune diseases with high morbidity/mortality and limited treatment options Unique, Dual-Targeting Mechanism Robust Clinical Data Distinctive Strategy Tailored to Novel Mechanism Dual inhibition of TYK2 and JAKI is expected to potentially provide greater efficacy than agents that inhibit either alone in multiple highly inflammatory autoimmune diseases Statistically significant and clinically meaningful benefit in all five placebo-controlled studies completed to date (oral, once-daily) Exposure in >1,000 subjects and patients to date; safety profile consistent with approved JAK inhibitors Rather than standard set of highly competitive broad market JAK indications, pursue series of uncrowded, orphan and specialty autoimmune diseases with highest morbidity/mortality and where we expect that both TYK2 and JAK1 inhibition will contribute to efficacy Two Ongoing Registrational Programs Single registrational phase 3 study in dermatomyositis initiated Large, global phase 2B study in lupus with enrollment complete; data anticipated in 2H 2023 (designed to serve as one of two registrational studies) Additional indications to be announced Strong Intellectual Property Position Patent protection expected through ~2039 roivant 25 25 For investor audiences only#262023: Biggest Year Yet for Roivant roivant#272023: Roivant's Biggest Year Yet VTAMA (tapinarof) cream 1% r Expanded VTAMA Coverage and Reach VTAMA Phase 3 Readout in AD RVT-3101 (Anti-TL1A) UC Phase 2b Data Ongoing 1H 2023 1H 2023 ༧ང་ IMVT-1402 (Next-Gen Anti-FcRn) Human Data Mid-2023 Brepocitinib (TYK2/JAK1) Pivotal Trial Readout in SLE 2H 2023 Ongoing coverage expansion expected to increase net yield and add revenue Positive readout would pave way to atopic dermatitis market, which is ~4x the size of psoriasis market Positive final data from global Phase 2b would validate best-in-class potential Two potentially best-in- class anti-FcRn antibodies with deeper IgG reduction and simple subQ dosing give flexibility to maximize value across indications If positive could serve as one of two registrational trials in a large market with high unmet need roivant References are to calendar years. 27 For investor audiences only#28Key Catalysts Program Vant Catalyst VTAMA (tapinarof) cream Updates on commercial launch of VTAMA in psoriasis Expected Timing Roivant pipeline growth r LNP platform ३ ли New mid/late-stage in-licensing announcements Updates to LNP patent litigation Roivant Discovery Updates on discovery programs and technology Ongoing Ongoing Ongoing Ongoing VTAMA (tapinarof) cream Topline data from Phase 3 trials in atopic dermatitis 1H 2023 IMVT-1402 Y Initial data from Phase 1 trial Mid 2023 RVT-3101 r Final data from Phase 2B trial in ulcerative colitis 1H 2023 Brepocitinib Topline data from potentially registrational Phase 2B trial in systemic lupus erythematosus 2H 2023 Batoclimab Y Initial data from Phase 2 trial in Graves' disease 2H 2023 RVT-2001 Batoclimab Data from RVT-2001 Phase 1/2 trial in lower-risk myelodysplastic syndrome Initial data from pivotal Phase 2B trial in chronic inflammatory demyelinating polyneuropathy 2H 2023 1H 2024 Namilumab n Topline data from Phase 2 trial in sarcoidosis 1H 2024 Batoclimab A Topline data from Phase 3 trial in myasthenia gravis 2H 2024 Batoclimab Y Topline data from Phase 3 trials in thyroid eye disease Topline data from Phase 3 trial in dermatomyositis 1H 2025 2025 Brepocitinib roivant All catalyst timings are based on current expectations and, where applicable, contingent on FDA feedback, and may be subject to change. All timelines reference calendar years. 28 For investor audiences only#29Thank you. roivant

Download to PowerPoint

Download presentation as an editable powerpoint.

Related

1st Quarter 2021 Earnings Presentation image

1st Quarter 2021 Earnings Presentation

Technology

Rackspace Technology Q4 2022 Earnings Presentation image

Rackspace Technology Q4 2022 Earnings Presentation

Technology

CBAK Energy Technology Investor Presentation image

CBAK Energy Technology Investor Presentation

Technology

Jianpu Technology Inc 23Q1 Presentation image

Jianpu Technology Inc 23Q1 Presentation

Technology

High Performance Computing Capabilities image

High Performance Computing Capabilities

Technology

SOLOMON Deep Learning Case Studies image

SOLOMON Deep Learning Case Studies

Technology

1Q20 Earnings image

1Q20 Earnings

Technology

Nutanix Corporate Overview image

Nutanix Corporate Overview

Technology