NIU Phase 2 Topline Results and Corporate Updates

April 2024

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 here with respect to the results of the NEPTUNE study of brepocitinib in noninfectious uveitis, 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.

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 brepocitinib and certain other products and product candidates generated from separate, independent studies and that do not come from a head-to-head analysis. Differences exist between study or trial designs and patient characteristics and caution should be exercised when comparing data across studies. Data regarding other products and product candidates is based on publicly available information.

This presentation also contains estimates and other statistical data made by independent parties and by us relating to data about our industry. This data involves a number of assumptions and limitations, and you are cautioned not to give undue weight to such estimates. In addition, projections, assumptions, and estimates of our future performance and the future performance of the markets in which we operate are necessarily subject to a high degree of uncertainty and risk. These and other factors could cause results to differ materially from those expressed in the estimates made by the independent parties and by us.

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Disclaimer

This presentation is intended for the investor community only; it is not intended to promote the product candidates referenced herein or otherwise influence healthcare prescribing decisions.

Agenda

  • Roivant in 2024

  • Capital Allocation Update

  • Positive Results from Phase 2 NEPTUNE Study of Brepocitinib in NIU

  • Q&A

2024 Will Be a Year of Expansion for Roivant

Bolster pipeline through creative, win-win deals with partners, enabled by execution track record and strong balance sheet

Anticipate that deeper IgG suppression may lead to greater efficacy across multiple indications with readouts for batoclimab in

CIDP and MG

Roivant Announces $1.5B Share Repurchase Program Including Purchase of Entire Sumitomo Stake for $648M, Reducing Share Count by ~9%

Goal of repurchase program is to drive value creation for investors by taking advantage of price dislocation to reduce share count and shareholder concentration, while maintaining strong price discipline

Roivant is purchasing Sumitomo's full stake of 71.3M shares for $9.10/share ($648M), reducing share count by approximately 9%1

Board approved a share repurchase program of up to $1.5B through a potential combination of open-market repurchases, tender offers and private transactions

We remain confident that our capital position is sufficient to fully fund our existing programs through profitability, expand our pipeline with business development opportunities and additional indications, and return capital to shareholders

1. Based on 805.8 million shares outstanding as of February 9, 2024

Our Next Chapter is Anchored by Our Robust Late-Stage Pipeline

Exciting late-stage pipeline with 6 ongoing registrational trials in multi-billion dollar markets and 4-5 additional potentially registrational programs with IMVT-1402 expected by March 2025

ModalityPreclinicalPhase 1

Phase 2

Phase 3

Approved

Psoriasis | Dermavant

Topical

Atopic Dermatitis | Dermavant

Topical

sNDA Submitted

BATOCLIMAB Myasthenia Gravis | Immunovant

Biologic

BATOCLIMAB Thyroid Eye Disease | Immunovant

Biologic

BATOCLIMAB Chronic Inflammatory Demyelinating Polyneuropathy | Immunovant

Biologic

BATOCLIMAB Graves' Disease | Immunovant

Biologic

IMVT-1402 Numerous Indications | Immunovant

Biologic

BREPOCITINIB Dermatomyositis | Priovant

Small Molecule

BREPOCITINIB Non-Infectious Uveitis | Priovant

Small Molecule

BREPOCITINIB Other Indications | Priovant

Small Molecule

NAMILUMAB Sarcoidosis | Kinevant

Biologic

UNDISCLOSED Undisclosed Indications

Undisclosed

Pipeline reflects both ongoing clinical trials and expected upcoming trials. VTAMA has only received FDA approval for psoriasis, not atopic dermatitis. Other than VTAMA in psoriasis, all drugs are investigational and subject to regulatory approval.

Represents potentially registrational trials

Positive Results from Phase 2 NEPTUNE Study of Brepocitinib in NIU

Summary of NEPTUNE Study Results

All endpoints evaluated at week 24 were positive and dose-responsive

On pre-specified primary efficacy endpoint of Treatment Failure rate at week 24, brepocitinib 45 mg achieved lowest (best) observed rate (29%) among active NIU studies measuring this registrational endpoint

  • Approximately 2x lower (better) than observed rate in corresponding registrational study of Humira (VISUAL 1), the only approved non-steroidal treatment for NIU

Significant benefit also observed on macular edema, a major contributor to blindness in NIU patients

  • Data suggests potential to resolve macular edema in many patients and potential to prevent or reverse swelling before threshold for macular edema is reached and patient is formally diagnosed with UME

Success achieved despite a steroid taper more than twice as fast as precedent studies, including VISUAL 1

Brepocitinib: Potential Large Orphan Franchise

First Phase 3 readout expected in 2025 (dermatomyositis), with NDA submission to follow

Brepocitinib Background

Indication Strategy

  • Dual inhibitor of TYK2 and JAK1, optimized for highly inflammatory indications

  • Clinically meaningful benefit in seven phase 2 studies (once-daily oral administration)

  • Exposure in >1,400 subjects and patients suggests safety profile consistent with approved JAK inhibitors

  • IP protection expected to at least 2039

Significant Unmet Need & Commercial Opportunity in NIU

Uveitis is the fourth-leading cause of blindness among working-age population in the developed world1

  • Accounts for approximately 10% of cases of blindnessin U.S.2,3

  • Tens of thousands of new instances of legal blindness per year2

Etiology: Approximately half idiopathic, half in context of other systemic autoimmune disease4

Approximately 30,000 patients on biologics for non-anterior NIU, including Humira (only approved therapy) and off-label therapies5

  • Rapid growth rate from 2019-2023

No competitors in Phase 3, limited competition in Phase 2

At an orphan price point with differentiated data, multi-$B peak sales potential in post-biologic population alone

  • Additional potential blockbuster opportunity in broader non-anterior NIU population

  • 1. Barisani-Asenbauer, T., Maca, S.M., Mejdoubi, L. et al. Uveitis- a rare disease often associated with systemic diseases and infections- a systematic review of 2619 patients. Orphanet J Rare Dis 7, 57 (2012).

  • 2. Thorne et al, JAMA Ophthalmol. (2016).

  • 3. Emmett T. E.Cunningham & Manfred Zierhut (2021) Vision Loss in Uveitis, Ocular Immunology and Inflammation, 29:6, 1037-1039.

  • 4. Lopalco et al, Clin Exp Rheum 2018.

  • 5. Roivant/Priovant analysis of closed claims data from Inovalon. Includes idiopathic and sequela of other autoimmune disease. Includes Humira and off-label therapies.

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Roivant Sciences Ltd. published this content on 02 April 2024 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 02 April 2024 12:47:04 UTC.