Roivant
Overview
J.P. Morgan Healthcare Conference
January 9, 2023
Forward-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.
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For investor audiences only
2022 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
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
LNP patent litigation progressed in Roivant's favor
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For investor audiences only
- In Which We Built an Industry-Leading 2023 Catalyst Calendar
JPM 2022 | ||
Program | Catalyst | Expected Timing |
VTAMA | Topline data from Phase 3 | |
(tapinarof) | 1H 2023 | |
trials in atopic dermatitis | ||
cream | ||
JPM 2023 | |||||
Program | Catalyst | Expected Timing | |||
RVT-3101 | Induction data from Phase | 1Q 2023 | |||
2B trial in ulcerative colitis | |||||
VTAMA | |||||
Topline data from Phase 3 | |||||
(tapinarof) | 1H 2023 | ||||
trials in atopic dermatitis | |||||
cream | |||||
Final data including chronic | |||||
RVT-3101 | therapy period from Phase | 1H 2023 | |||
2B trial in ulcerative colitis | |||||
IMVT-1402 | Initial data from Phase 1 | Mid 2023 | |||
trial | |||||
Topline data from | |||||
Brepocitinib | potentially registrational | 2H 2023 | |||
Phase 2B trial in systemic | |||||
lupus erythematosus
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For investor audiences only
Roivant Pipeline
Modality | Preclinical | Phase 1 | Phase 2 | Phase 3 | Approved | |
Psoriasis | Dermavant | Topical | ► | ||||
Atopic Dermatitis | Dermavant | Topical | ► | ||||
RVT-3101 Ulcerative Colitis | New Vant | Biologic | ► | ||||
RVT-3101 Crohn's Diseases | New Vant | Biologic | ► | ||||
BREPOCITINIB Dermatomyositis | Priovant | Small Molecule | ► | ||||
BREPOCITINIB Systemic Lupus Erythematosus | Priovant | Small Molecule | ► | ||||
BREPOCITINIB Other Indications | Priovant | Small Molecule | ► | ||||
BATOCLIMAB Myasthenia Gravis | Immunovant | Biologic | ► | ||||
BATOCLIMAB Thyroid Eye Disease | Immunovant | Biologic | ► | ||||
BATOCLIMAB Chronic Inflammatory Demyelinating Polyneuropathy | Immunovant | Biologic | ► | ||||
BATOCLIMAB Graves' Disease | Immunovant | Biologic | ► | ||||
BATOCLIMAB Warm Autoimmune Hemolytic Anemia | Immunovant | Biologic | ► | ||||
IMVT-1402 Numerous Indications | Immunovant | Biologic | ► | ||||
NAMILUMAB Sarcoidosis | Kinevant | Biologic | ► | ||||
RVT-2001 Transfusion-Dependent Anemia in Patients with Lower-Risk MDS | Hemavant | Small Molecule | ► | ||||
Pipeline reflects both ongoing clinical trials and expected upcoming trials. VTAMA has only received FDA approval for psoriasis, not atopic dermatitis.
- Represents registrational or potentially registrational trials
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For investor audiences only
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Roivant Sciences Ltd. published this content on 09 January 2023 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 09 January 2023 14:08:02 UTC.