Financial Results and Business Update for the Year Ended March 31, 2024
May 30, 2024
Speakers
Matthew | Richard | Frank | Eric Venker, MD, | Mayukh |
Gline | Pulik | Torti, MD | PharmD | Sukhatme, MD |
Chief | Chief | Vant Chair | President and | President and |
Executive Officer | Financial Officer | Chief Operating | Chief Investment | |
Officer | Officer |
2
For investor audiences only
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, potential uses of cash and capital allocation, research and development plans, profitability, the anticipated timing, costs, design, conduct and results of our ongoing and planned preclinical studies and clinical trials for our products and product candidates, any commercial potential of our products and product candidates, and the benefits expected to be realized from Dermavant's renegotiation of its existing debt obligations, 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 initial or topline study results presented here for (i) brepocitinib in non-infectious uveitis and (ii) batoclimab in Graves' Disease are based on initial analyses of key efficacy and safety data and such data may not accurately reflect the complete results of those studies.
These forward-looking statements may 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.govand 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 for brepocitinib as compared to certain other products generated from separate, independent studies and that do not come from a 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.
VTAMA cream is only FDA-approved for the topical treatment of plaque psoriasis in adults but is under clinical investigation for the treatment of atopic dermatitis in adults and children aged two (2) years old and above.
Non-GAAP Financial Information
The discussions during this conference call will include certain financial measures that were not prepared in accordance with U.S. generally accepted accounting principles (GAAP). Additional information regarding non-GAAP financial measures can be found on slide 31 and in our earnings release furnished with our Current Report on Form 8-K dated May 30, 2024. Any non-GAAP financial measures presented are not, and should not be viewed as, substitutes for financial measures required by U.S. GAAP, have no standardized meaning prescribed by U.S. GAAP and may not be comparable to the calculation of similar measures of other companies.
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.
3
For investor audiences only
Agenda
- Roivant in 2024
- Immunovant Updates
- Recent Brepocitinib NIU Data
- VTAMA® Psoriasis Launch and Atopic Dermatitis Program
- Upcoming Catalysts and Other Business Updates
- Financial Update
- Q&A
4
For investor audiences only
2024 Will Be a Year of Expansion for Roivant
Deliver Clinical Data for Leading Anti-FcRn Franchise and Announce Development Plans for 1402
Anticipate that deeper IgG suppression may lead to greater efficacy across
multiple indications with
data from batoclimab to inform IMVT-1402 trial design
Advance Clinical | File VTAMA sNDA in | Expand Pipeline | Finalize Capital |
Development In a | AD & Accelerate PsO | Through Mid-Late- | Allocation Strategy |
Range of | Revenue Growth | Stage Business | Across Best Value |
Underappreciated | Development | Creation | |
Pipeline Opportunities | Opportunities |
Expect clinical trial | sNDA filed with FDA PDUFA | Bolster pipeline through | Plan to be prudent and |
readouts for brepocitinib | action expected 4Q 2024; | creative, win-win deals | thoughtful; will prioritize |
and namilumab to inform | accelerate PsO revenue | with partners, enabled by | optimizing shareholder |
portfolio expansion | growth through script | execution track record and | base for next era of |
decisions | expansion and GTN yield | strong balance sheet | Roivant growth |
accretion |
All timelines reference calendar years. | 5 |
For investor audiences only
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
Modality
Preclinical
Phase 1
Phase 2
Phase 3
Approved
Psoriasis | Dermavant | Topical | ► | |||||
Atopic Dermatitis | Dermavant | Topical | sNDA Filed | |||||
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 Indication | 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 | 6 |
For investor audiences only
Immunovant Updates
Ongoing Progress at Immunovant Building a Leading FcRn Franchise
IMVT-1402 Development
Progress
- Held successful Type B meeting with the FDA on 1402 development
- On track to initiate 4-5 potentially registrational programs for IMVT- 1402 over this fiscal year
Portfolio Optimization | IMVT-1402 IP | |
• IMVT-1402 designated as lead | • Recently issued patent for IMVT- |
program | 1402 covering composition of |
• Batoclimab efforts will be | matter, method of use, and |
methods for manufacturing | |
optimized to inform IMVT-1402 | |
development plans | • IP extends to June 2043 before |
• Retain optionality for registration | any use of patent term extension |
with batoclimab if data is | |
supportive |
8
For investor audiences only
Updates Across Broad Spectrum of Indications Where Greater IgG Reduction
May Drive Best-In-Class Efficacy
GD
MG
CIDP
TED
Detailed results from the study of batoclimab as well as an overview of the development plan of IMVT-1402 expected in the fall of 2024
Topline data from the batoclimab study is expected over this fiscal year, and Immunovant is expected to begin potentially registrational development with IMVT-1402 in the same timeframe
The batoclimab study will be run approximately two quarters longer prior to unblinding period 1 to better ensure that the data from the batoclimab trial can be used to optimize the IMVT-1402 CIDP trial design
Topline data from the potentially registrational study of batoclimab remains on track to read out in the first half of calendar year 2025, and represents a potential first-in-class opportunity
9
For investor audiences only
Consistent Evidence Across Programs and Indications that Greater IgG
Reduction Leads to Greater Efficacy1
MG
TED
GD
RA ITP
Company | Evidence of Greater IgG Reductions Translating to Clinical Benefit | |
Patient-level scatter plot showed that greater IgG declines ➔ greater
MG-ADL improvements2,3
Greater IgG reduction across arms ➔ higher rates of anti-TSHR antibody reduction and greater clinical response rates
Greater IgG reduction across treatment cohorts ➔ higher rates of anti-TSHR autoantibody reduction and numerically higher responses for ATD dose tapering and ATD discontinuation observed
Greater IgG reduction across arms ➔ greater platelet responses4
In those patients with greater IgG reduction ➔ correlation with greater autoAb reduction ➔ correlation with greater clinical response5
1. Many of the analyses above were post-hoc and not all were statistically significant. Cross trial and post-hoc analyses are inherently limited and are presented for hypothesis generating purposes only, nevertheless | 10 |
consistent and numerically positive increases in efficacy were observed as noted above; 2. argenx JP Morgan Healthcare Conference Presentation January 2021; 3. Momenta Vivacity-MG Interim Phase 2 Investor | |
Presentation, 2020; 4. IgG reduction at day 8 estimated by WebPlotDigitizer for 4mg/kg, 7mg/kg and 10mg/kg doses; 5. Janssen Research & Development, ACR poster, November 2023..MG: Myasthenia gravis, TED: | For investor audiences only |
Thyroid eye disease, GD: Graves' disease, ITP: Immune thrombocytopenic purpura, RA: Rheumatoid arthritis | |
Attachments
- Original Link
- Original Document
- Permalink
Disclaimer
Roivant Sciences Ltd. published this content on 30 May 2024 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 30 May 2024 13:05:08 UTC.