# EDGAR Filing Document

**Accession Number:** 0001635088
**File Stem:** 0001140361-25-035190
**Filing Date:** 2025-9
**Character Count:** 47837
**Document Hash:** 27b1e7cad9258ab4b92f1f17fc2f7cef
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001140361-25-035190.hdr.sgml**: 20250917

**ACCESSION NUMBER**: 0001140361-25-035190

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 46

**CONFORMED PERIOD OF REPORT**: 20250917

**ITEM INFORMATION**: Regulation FD Disclosure

**ITEM INFORMATION**: Other Events

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20250917

**DATE AS OF CHANGE**: 20250917

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** Roivant Sciences Ltd.
- **CENTRAL INDEX KEY:** 0001635088
- **STANDARD INDUSTRIAL CLASSIFICATION:** PHARMACEUTICAL PREPARATIONS [2834]
- **ORGANIZATION NAME:** 03 Life Sciences
- **EIN:** 981173944
- **STATE OF INCORPORATION:** D0
- **FISCAL YEAR END:** 0331

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-40782
- **FILM NUMBER:** 251318794

**BUSINESS ADDRESS:**
- **ADDRESS IS A NON US LOCATION:** YES
- **STREET 1:** 7TH FLOOR, 50 BROADWAY
- **CITY:** LONDON
- **NON US STATE TERRITORY:** UNITED KINGDOM
- **PROVINCE COUNTRY:** X0
- **ZIP:** SW1H 0DB
- **BUSINESS PHONE:** 441-295-5950

**MAIL ADDRESS:**
- **ADDRESS IS A NON US LOCATION:** YES
- **STREET 1:** 7TH FLOOR, 50 BROADWAY
- **CITY:** LONDON
- **NON US STATE TERRITORY:** UNITED KINGDOM
- **PROVINCE COUNTRY:** X0
- **ZIP:** SW1H 0DB

?xml version='1.0' encoding='ASCII'?

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### UNITED STATES

### SECURITIES AND EXCHANGE COMMISSION

#### WASHINGTON, D.C. 20549

### FORM 8-K

#### CURRENT REPORT

#### Pursuant to Section 13 or 15(d) of the

#### Securities Exchange Act of 1934

#### Date of report (Date of earliest event reported): September 17, 2025

## Roivant Sciences Ltd.

#### (Exact name of registrant as specified in its charter)

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| | | |
|:---|:---|:---|
| **Bermuda**<br>| **001-40782**<br>| **98-1173944**<br>|
| **(State or other jurisdiction of incorporation)** | **(Commission File Number)** | **(I.R.S. Employer Identification No.)** |

---

#### 7th Floor

#### 50 Broadway

#### London SW1H 0DB

#### United Kingdom

#### (Address of principal executive offices, and Zip Code)

#### +44 207 400-3347

#### Registrant's Telephone Number, Including Area Code

#### Not Applicable

#### (Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (*see* General Instruction A.2. below):

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

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| | | |
|:---|:---|:---|
| **Title of each class** | **Trading Symbol(s)** | **Name of each exchange on which registered** |
| **Common Shares, $0.0000000341740141 per share**<br>| **ROIV**<br>| **The Nasdaq Global Select Market** |

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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

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| | |
|:---|:---|
| **Item 7.01** | **Regulation FD Disclosure.** |

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On September 17, 2025, Roivant Sciences Ltd. (the "Company") issued a press release announcing positive results from the Phase 3 VALOR study evaluating brepocitinib in dermatomyositis at its subsidiary Priovant Therapeutics. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

The information furnished under this Item 7.01, including Exhibit 99.1, shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934 or subject to the liabilities of that section or Sections 11 and 12(a)(2) of the Securities Act of 1933. The information in this Item 7.01, including Exhibit 99.1, shall not be deemed incorporated by reference into any other filing with the U.S. Securities Exchange Commission made by the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing.

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| | |
|:---|:---|
| **Item 8.01** | **Other Events.** |

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On September 17, 2025, the Company posted a presentation regarding the results from the Phase 3 VALOR study on the "Events & Presentations" page of its investor relations website at https://investor.roivant.com and will host a conference call and webcast to discuss the results at 8:00 a.m. E.D.T. on September 17, 2025. A copy of the presentation to be used by the Company during the conference call is filed as Exhibit 99.2 to this Current Report on Form 8-K and is incorporated herein by reference. The contents of the Company's website referenced in this Current Report on Form 8-K are not incorporated into this Current Report on Form 8-K.

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| | |
|:---|:---|
| **Item 9.01** | **Financial Statements and Exhibits.** |

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&nbsp;&nbsp;&nbsp;&nbsp;(d) Exhibits.

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| | |
|:---|:---|
| **Exhibit No.** | **Description of Exhibit** |
| [99.1](ef20055655_ex99-1.htm) | Press Release, dated September 17, 2025. |
| [99.2](ef20055655_ex99-2.htm) | Presentation, dated September 17, 2025. |
| 104 | Cover Page Interactive Data File (embedded with Inline XBRL document). |

---

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#### SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

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| | |
|:---|:---|
| **ROIVANT SCIENCES LTD.** | **ROIVANT SCIENCES LTD.** |
| By: | /s/ Keyur Parekh |
| Name: Keyur Parekh | Name: Keyur Parekh |
| Title: Authorized Signatory | Title: Authorized Signatory |
| Dated: September 17, 2025 | Dated: September 17, 2025 |

---

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## Exhibit 99.1

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**Exhibit 99.1**<br>

Roivant and Priovant Announce Positive Phase 3 VALOR Study Results for Brepocitinib in 52-Week Placebo-Controlled Trial in Dermatomyositis (DM)

• Once-daily oral brepocitinib 30 mg demonstrated clinically meaningful and statistically significant improvement compared to placebo on the primary endpoint and all nine key secondary endpoints, including measurements of skin disease, muscle disease, steroid-sparing effect, and rapidity of onset

• On the primary endpoint, brepocitinib 30 mg achieved a week 52 mean Total Improvement Score (TIS) of 46.5 compared to 31.2 for placebo (p=0.0006), even with nearly twice as many patients coming off background steroids on brepocitinib 30 mg compared to placebo

<br> • More than two thirds of brepocitinib 30 mg patients experienced at least a moderate response (TIS≥40), and nearly half experienced a major response (TIS≥60)

<br> • Consistent dose response was seen between 30 mg and 15 mg dose arms, establishing 30 mg dose as optimal in this setting

<br> • Safety profile was consistent with previous clinical trials of brepocitinib and NDA filing is planned for calendar 1H 2026

<br> • Roivant will host an investor call to discuss these updates today, September 17, 2025, at 8:00 a.m. EDT

BASEL, Switzerland, LONDON, NEW YORK and DURHAM, NC, September 17, 2025 (GLOBE NEWSWIRE) – Roivant (Nasdaq: ROIV) and Priovant Therapeutics today announced positive results from the Phase 3 VALOR study evaluating brepocitinib in dermatomyositis (DM).

On the primary endpoint, brepocitinib 30 mg achieved a week 52 mean TIS of 46.5 compared to 31.2 for placebo (p=0.0006). A statistically significant difference between brepocitinib 30 mg and placebo on mean TIS was seen at all time points, including as early as week 4. This result represents the first ever positive outcome for a 52-week placebo-controlled trial in DM, and the first ever positive registrational trial for a targeted therapy in DM.

"Dermatomyositis is an incredibly debilitating autoimmune disease for patients, and we urgently need novel, approved efficacious therapies," said Dr. Ruth Ann Vleugels, M.D., M.P.H., M.B.A., Heidi and Scott C. Schuster Distinguished Chair in Dermatology, Founding Director of the Autoimmune Skin Disease Center and Connective Tissue Disease Clinics at Brigham and Women's Hospital and Program Director for the Dermatology-Rheumatology Fellowship at Harvard Medical School. "The VALOR study's success represents a groundbreaking moment for the dermatomyositis field, and the results reinforce brepocitinib's potential to serve as a deeply impactful treatment option for a substantial number of dermatomyositis patients once approved."

Brepocitinib also demonstrated clinically meaningful and statistically significant improvement over placebo on all nine key secondary endpoints. Dose-dependent response between brepocitinib 30 mg and brepocitinib 15 mg was seen consistently across the primary and secondary endpoints.

Approximately 75% of patients entered the VALOR study on background steroids, with a mean baseline dose of 12.2 mg/day in the brepocitinib 30 mg arm and 11.3 mg/day in the placebo arm. Of these patients on background steroids, 62% of brepocitinib 30 mg patients achieved a steroid dose ≤2.5 mg/day by the end of the study (compared to 34% for placebo) and 42% of brepocitinib 30 mg patients were able to come off steroids altogether (compared to 23% for placebo).

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Even against this backdrop, clinical improvement in the brepocitinib 30 mg arm was rapid, deep, lasting and broad, both in absolute terms and relative to placebo:

• Brepocitinib demonstrated clinically meaningful and statistically significant improvement relative to placebo on the CDASI (skin), MMT-8 (motor strength) and HAQ-Disability Index (patient questionnaire around daily living activities requiring functional muscle strength, like getting dressed or walking up five steps).

• More than two-thirds of brepocitinib 30 mg patients experienced at least a moderate response (TIS≥40), and nearly half experienced a major response (TIS≥60); of patients who entered the trial with moderate-to-severe skin disease, 44% on brepocitinib 30 mg achieved cutaneous clinical remission by week 52, compared to 21% on placebo.

<br> • Both TIS and CDASI achieved statistically significant separation from placebo as early as week 4 and sustained that separation at every assessment out to one year; median time to a TIS≥40 response was approximately 8 weeks.

The observed brepocitinib 30 mg safety profile was consistent with previous brepocitinib clinical trials. Adverse events of special interest (AESIs), which included malignancy, cardiovascular events, and thromboembolic events, did not occur with greater frequency in the brepocitinib 30 mg arm than the placebo arm.

"We are thrilled with the results of the VALOR study, and I would like to thank all of the patients, investigators, and study site staff who contributed to this important research achievement," said Ben Zimmer, Priovant CEO. "We are excited to continue working towards the rapid approval of brepocitinib in dermatomyositis and our broader goal of developing brepocitinib as a transformational therapy for multiple highly morbid autoimmune diseases where the need for novel efficacious therapies is greatest."

"The VALOR study is a hallmark example of what Roivant does best: identify a high value program with a differentiated mechanism of action, focus on creative development plans in indications like DM with high unmet need, and deliver on clinical execution excellence," said Mayukh Sukhatme, Roivant President and Chief Investment Officer. "I am extremely proud of Roivant's continued track record with VALOR as the 12th consecutive positive Phase 3 study for the company – an unparalleled achievement and a testament to Roivant's unrelenting focus on clinical strategy and execution."

Priovant plans to file an NDA for brepocitinib in dermatomyositis in the first half of 2026.

#### About Dermatomyositis
Dermatomyositis (DM) is a multi-organ idiopathic inflammatory condition that affects approximately 50,000 adults in the United States. DM is characterized by debilitating muscle weakness and skin lesions. DM-related muscle weakness causes significant impairment to daily living activities, such as walking up stairs, carrying groceries, and getting dressed. Dermatomyositis rashes often affect large portions of a patient's body including the scalp and are often disfiguring and painful. No targeted therapies are approved for DM, and a majority of patients require high-dose chronic oral corticosteroids.

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#### About the VALOR Study
VALOR was the longest and largest interventional DM study ever conducted, enrolling 241 subjects globally. Subjects were randomized 1:1:1 to brepocitinib 30 mg, brepocitinib 15 mg and placebo, with one-year of double-blind treatment. The primary endpoint was the difference at week 52 between brepocitinib and placebo in mean Total Improvement Score (TIS), a composite endpoint of multiple measures of DM disease activity.

#### Investor Conference Call Information
Roivant will host a live conference call and webcast at 8:00 a.m. EDT on Wednesday, September 17, 2025, to discuss the Phase 3 results for brepocitinib in dermatomyositis. To access the conference call by phone, please register online using this <u>registration link</u>. The presentation and webcast details are available under "Events & Presentations" in the Investors section of the Roivant website at https://investor.roivant.com/news-events/events. The archived webcast will be available on Roivant's website after the conference call.

#### About Priovant

#### <br>
Priovant Therapeutics is a biotechnology company dedicated to developing novel therapies for autoimmune diseases with high morbidity and few available treatment options. The company's lead asset is brepocitinib, a dual selective inhibitor of TYK2 and JAK1. Through dual TYK2/JAK1 inhibition, brepocitinib distinctively suppresses key cytokines linked to autoimmunity—including type I IFN, type II IFN, IL-6, IL-12, and IL-23—with a single, targeted, once-daily oral therapy. Brepocitinib recently generated positive Phase 3 data in dermatomyositis, and an NDA submission is planned for the first half of 2026. Brepocitinib is also being evaluated in non-infectious uveitis (Phase 3) and cutaneous sarcoidosis (Phase 2).

#### About Roivant
Roivant (Nasdaq: ROIV) is a biopharmaceutical company that aims to improve the lives of patients by accelerating the development and commercialization of medicines that matter. Roivant's pipeline includes brepocitinib, a potent small molecule inhibitor of TYK2 and JAK1 in development for the treatment of dermatomyositis, non-infectious uveitis and cutaneous sarcoidosis; IMVT-1402 and batoclimab, fully human monoclonal antibodies targeting FcRn in development across several IgG-mediated autoimmune indications; and mosliciguat, an inhaled sGC activator in development for pulmonary hypertension associated with interstitial lung disease. We advance our pipeline by creating nimble subsidiaries or "Vants" to develop and commercialize our medicines and technologies. Beyond therapeutics, Roivant also incubates discovery-stage companies and health technology startups complementary to its biopharmaceutical business. For more information, visit <u>https://roivant.com</u>.

#### Roivant Forward-Looking Statements
This press release contains forward-looking statements. Statements in this press release may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended (the "Securities Act"), and Section 21E of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), which are usually identified by the use of words such as "anticipate," "believe," "continue," "could," "estimate," "expect," "intends," "may," "might," "plan," "possible," "potential," "predict," "project," "should," "would" and variations of such words or similar expressions. The words may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act.

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Our forward-looking statements include, but are not limited to, statements regarding our or our management team's expectations, hopes, beliefs, intentions or strategies regarding the future, and statements that are not historical facts, including statements about the clinical and therapeutic potential of our product candidates, the availability and success of topline results from our ongoing clinical trials and any commercial potential of our product candidates following applicable regulatory approvals. In addition, any statements that refer to projections, forecasts or other characterizations of future events, results or circumstances, including any underlying assumptions, are forward-looking statements. Actual results may differ materially from those contemplated in these statements due to a variety of risks, uncertainties and other factors.

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 Risk Factors section of our filings with the U.S. Securities and Exchange Commission. Moreover, 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 press release, 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.

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| |
|:---|
| **Contacts:** |
| <u>Investors</u> |
| Keyur Parekh |
| keyur.parekh@roivant.com |
| <u>Media</u> |
| Stephanie Lee |
| <u>stephanie.lee@roivant.com</u> |
| <u>Priovant</u> |
| Daniel Herz Roiphe |
| <u>daniel.herz-roiphe@priovant.com</u> |

---

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## Exhibit 99.2

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**Exhibit 99.2**<br>

<br> ![](image00001.jpg)

Brepocitinib in DM: VALOR Topline Results September 17, 2025

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![](image00002.jpg)

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, and any commercial potential of our products and product candidates 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. 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.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 for brepocitinib as compared to a potential competitor product generated from separate, independent studies and that do not come from head- to-head analyses. Differences exist between study or trial designs and subject characteristics and caution should be exercised when comparing data across studies. Data regarding other products is based on publicly available information. 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.

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![](image00003.jpg)

Roivant in 2025: Transformational Potential 3 For investor audiences only Note: All references are to calendar years and are approximate and subject to change. The timing of the litigation-related events noted above is subject to change, including at the discretion of the court. See Slide 2 for further information on these forward- looking statements Validate IMVT-1402 First- /Best-in-Class Potential Bato MG & CIDP data further validate "Deeper is Better"; TED data expected 2H '25 Focused execution on 6 announced IMVT-1402 indications Registrational Dermatomyositis (DM) Readout Pivotal study will enable brepocitinib to be first novel oral DM drug with multi-year lead over any other late-stage program; planned FDA filing in 1H '26 Advance LNP Litigation with Moderna and Pfizer/BioNTech Summary judgment phase ongoing in US Moderna case; jury trial scheduled for March 2026 Ongoing progress following Markman ruling in Pfizer/BioNTech case

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![](image00004.jpg)

4 For investor audiences only Robust Late-Stage Pipeline with 11 Registrational Trials in Indications with Blockbuster Potential Focusing on Clinical Trial Execution to Drive Significant Potential Value Note: Trials listed as registrational include those that we believe are potentially registrational Note: All references are to calendar years and are approximate and subject to change. See Slide 2 for further information on these forward-looking statements Modality Proof of Concept Registrational Status BREPOCITINIB Dermatomyositis \| Priovant Small Molecule FDA Filing expected 1H 2026 BREPOCITINIB Non-Infectious Uveitis \| Priovant Small Molecule Actively Enrolling BREPOCITINIB Cutaneous Sarcoidosis \| Priovant Small Molecule ► Actively Enrolling IMVT-1402 Graves' Disease \| Immunovant Biologic Actively Enrolling IMVT-1402 Difficult-to-Treat Rheumatoid Arthritis \| Immunovant Biologic Actively Enrolling IMVT-1402 Myasthenia Gravis \| Immunovant Biologic Actively Enrolling IMVT-1402 Sjögren's Disease \| Immunovant Biologic Actively Enrolling IMVT-1402 Chronic Inflammatory Demyelinating Polyneuropathy \| Immunovant Biologic Actively Enrolling IMVT-1402 Cutaneous Lupus Erythematosus \| Immunovant Biologic ► Actively Enrolling BATOCLIMAB Thyroid Eye Disease \| Immunovant Biologic Topline expected 2H 2025 MOSLICIGUAT Pulmonary Hypertension associated with Interstitial Lung Disease \| Pulmovant Inhaled ► Actively Enrolling ONGOING BD Pipeline Expansion Opportunities \| Roivant

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![](image00034.jpg)

5 For investor audiences only Brepocitinib Data in DM Kicks Off 36 Months Stacked with Potential Readouts and Launches Note: Figure is illustrative of potential registrational data readouts and product launches and is not intended to be representative of timelines on the events noted. Trials listed as registrational include those that we believe are potentially registrational Launch of Brepocitinib in NIU Launch of IMVT-1402 in Multiple Potential Blockbuster Indications Brepocitinib Registrational Data Readouts IMVT-1402 Registrational Data Readouts DM NIU D2T RA GD MG SjD CIDP Launch of Brepocitinib in DM Potential for additional indications and pipeline expansion

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![](image00006.jpg)

CONFIDENTIAL Brepocitinib VALOR Topline Results

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![](image00007.jpg)

CONFIDENTIAL Brepocitinib – Highlights of Phase 3 VALOR Study Results in DM VALOR succeeded, with highly significant, robust, and consistent data across primary and all key secondary endpoints Consistent dose response seen between 15 mg and 30 mg, establishing 30 mg dose as optimal in this setting Responses were rapid, deep, and broad, and showed clinically meaningful benefit to both muscle and skin symptoms Robust benefit: Brepocitinib 30 mg showed a mean TIS of 46.5, a delta of >15 points (p=0.0006) relative to placebo at week 52 (TIS of 31.2), even with twice as many patients coming off background steroids on brepocitinib compared to placebo Depth of response: >2/3 of brepocitinib 30 mg patients experienced at least a moderate response (TIS40), and nearly half experienced a major response (TIS60) Rapidity of response: Onset was rapid with median time to a TIS40 response of ~2 months; TIS and CDASI responses significant as early as week 4 Breadth of response: Positive data on all 10 pre-specified endpoints demonstrating improvement in both skin and muscle symptoms Brepocitinib 30 mg safety profile in VALOR was consistent with prior clinical studies FDA filing planned for calendar 1H 2026 7 For investor audiences only TIS: Total Improvement Score CDASI-A: Cutaneous Dermatomyositis Activity and Severity Index - Activity Subscore Product candidate is investigational and subject to regulatory approval. Timing is based on current expectations and subject to FDA feedback

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![](image00008.jpg)

CONFIDENTIAL DM Patients Have Significant Unmet Medical Needs 75% 13% 11% Therapies Received by Treated DM Patients Steroids & ISTs Alone IVIG-Containing Regimens Off-Label Targeted Therapy-Containing Regimens (No IVIG) Standard-of-care in DM is largely unchanged since the 1980s: combinations of corticosteroids and off-label ISTs Patient and physician need for modern, targeted therapies is extraordinarily high given that unapproved targeted therapies with no RCT data (including JAK inhibitors) are used off-label at rates comparable to IVIg Even among patients treated with IVIg or off-label targeted therapies, chronic high- dose steroid use remains high, with most requiring doses ≥10 mg/day for ≥100 days/year DM: Dermatomyositis IST: Immunosuppressive therapy IVIG: Intravenous immunoglobulin RCT: Randomized controlled trial Data Source: Analysis by Roivant/Priovant using closed claims data from Inovalon. Analysis includes patients with DM with continuous enrollment from 2020-2022. Conclusions corroborated through independent Veeva Compass open claims data through 2024. 8 For investor audiences only

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![](image00009.jpg)

CONFIDENTIAL VALOR Study Success Represents a Landmark Achievement in Dermatomyositis Field Extensive track record of failure for targeted therapies in dermatomyositis, even among approved drugs that are blockbusters in other I&I indications Failed in DM and PM Failed in DM Failed in DM and PM Failed in DM and PM Failed in DM, PM, and IMNM Failed in DM and PM Failed in DM and PM Failed in DM and PM First successful registrational trial for a targeted therapy in DM First successful 52-week placebo-controlled trial for any therapy in DM First successful placebo-controlled trial of any kind for a once-daily oral therapy in DM Largest interventional DM trial ever conducted, including other ongoing trials Brepocitinib Oral once-daily selective inhibitor of TYK2 and JAK1 DM: Dermatomyositis PM: Polymyositis IMNM: Immune-mediated necrotizing myopathy All trademarks are the property of their respective owners 9 For investor audiences only

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![](image00010.jpg)

CONFIDENTIAL Brepocitinib Inhibits both TYK2 and JAK1, Making It Particularly Well-Suited to Address Underlying DM Pathobiology Pathogenic Cytokine Role in DM Pathogenesis Brepocitinib Selective JAK1 Inhibitor Selective Tyk2 Inhibitor Type I IFN Antibody Type I IFN (IFNα/β) Lymphocyte Activation Type II IFN (IFNγ) Th1 Lymphocyte Polarization IL-12 IL-6 Th17 Lymphocyte Polarization B Cell Activation Partial IL-23 10 For investor audiences only

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![](image00011.jpg)

CONFIDENTIAL Key Endpoint Important Features P-Value Mean TIS (Primary) Composite endpoint, focus on muscle disease and global benefit 0.0006 CDASI-A change from baseline at Week 52 Improvement in skin disease activity 0.0006 DMOMS at Week 52 DM-specific muscle and skin composite measure of benefit 0.0014 TIS40 Response at Week 52 Moderate TIS response (focus on global benefit / muscle) 0.0040 Time to Consecutive TIS40 Response by Week 52 Time to onset of sustained benefit (particularly high bar) 0.0155 Patients achieving TIS40 Response + ≤2.5 mg OCS at Week 52 Achievement of clinical response and steroid reduction 0.0006 CDASI-A 40% Response with ≥4-point improvement at Week 52 Clinically meaningful skin response 0.0357 TIS60 Response at Week 52 Major TIS response – Highest TIS response threshold 0.0126 Change from baseline in HAQ-DI at Week 52 Improvement in physical and functional disability and daily living activities related to muscle strength 0.0035 Change from baseline in CDASI-A at Week 4 Rapid onset of skin response 0.0003 Brepocitinib 30 mg Achieved Statistically Significant Benefit On All Ten Ranked Endpoints Measurements of skin disease, muscle disease, rapidity of onset, and steroid sparing; consistent dose response was also seen across endpoints 11 For investor audiences only

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![](image00012.jpg)

CONFIDENTIAL Eligible Patients Definite or probable dermatomyositis (2017 EULAR/ACR criteria) Skin activity: CDASI-A ≥6 Muscle activity: MMT-8 ≤142 Refractory or intolerant to SOC therapy Permitted Background Therapy Oral IST, antimalarial, and/or OCS Primary Endpoint 30 mg vs. placebo mean Total Improvement Score at Week 52 BREPOCITINIB 15 MG QD (N = 81) BREPOCITINIB 30 MG QD (N = 81) PLACEBO (N = 79) Primary Endpoint 52-WEEK TREATMENT PERIOD 12 VALOR: Global Phase 3 Placebo- Controlled Study Evaluating Brepocitinib In Dermatomyositis N=241 adults with dermatomyositis Randomized 1:1:1 by PhGA-VAS IST: Immunosuppressive therapy OCS: Oral corticosteroids CDASI-A: Cutaneous Dermatomyositis Activity and Severity Index - Activity Subscore MMT-8: Manual testing of 8 muscle groups SOC: Standard of care PhGA-VAS: Physician's Global Assessment – Visual Analog Scale Mandatory corticosteroid taper to ≤5 mg/day from week 12 to 36; recommended further tapering at investigator discretion 12 For investor audiences only

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CONFIDENTIAL Brepocitinib 30 mg (n = 81) Brepocitinib 15 mg (n = 81) Placebo (n = 79) Mean Age (years) (± SD) 50.4 (14.5) 50.7 (12.1) 50.7 (13.5) Sex (Female) – no. (%) 65 (80%) 67 (83%) 55 (70%) Region: US/Canada – no. (%) 32 (40%) 34 (42%) 30 (38%) Disease Activity – no. (%) Mild 13 (16%) 19 (24%) 13 (16%) Moderate 54 (67%) 40 (49%) 48 (61%) Severe 14 (17%) 22 (27%) 18 (23%) Mean MMT-8 Score (± SD) 121.7 (16.4) 124.5 (14.2) 121.6 (17.0) Mean CDASI-A Score (± SD) 19.5 (11.3) 18.7 (11.3) 21.1 (12.0) History of ILD – no. (%) 19 (24%) 17 (21%) 11 (14%) Medications at Baseline – no. (%) Immunosuppressant 55 (68%) 57 (70%) 61 (77%) Antimalarial 24 (30%) 22 (27%) 19 (24%) Corticosteroids 60 (74%) 58 (72%) 64 (81%) Mean dose (mg/day) (± SD) 12.2 (5.7) 10.7 (6.2) 11.3 (5.9) MMT-8: Manual muscle testing of 8 muscles CDASI-A: Cutaneous Dermatomyositis Activity and Severity Index - Activity Subscore ILD: Interstitial lung disease Enrolled Population Had Highly Active, Multisystem Disease Arms were well-balanced across demographics, baseline disease activity, and background medications 13 For investor audiences only

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CONFIDENTIAL 241 subjects randomized Brepocitinib 30 mg (n=81) Brepocitinib 15 mg (n=81) Placebo (n=79) 75 (93%) completed the blinded treatment period 70 (86%) completed the blinded treatment period 65 (82%) completed the blinded treatment period 6 (7%) discontinued early 11 (14%) discontinued early 14 (18%) discontinued early Disposition: Brepocitinib Had Substantially Higher Completion Rate and Substantially Lower Rescue Rate Than Placebo 12 subjects (15%) received rescue medication 15 subjects (19%) received rescue medication 24 subjects (30%) received rescue medication 14 The definition of rescue medication was prespecified. This included initiation or clinically-meaningful increase in intensity of one or more systemic therapies given for treatment of DM. For investor audiences only

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CONFIDENTIAL Brepocitinib Showed Significant and Clinically Meaningful Improvement on Primary Endpoint of TIS 0 5 10 15 20 25 30 35 40 45 50 0 4 8 12 16 20 32 36 40 44 48 52 Mean TIS (± SE) Brepocitinib 30 mg (n = 81) Brepocitinib 15 mg (n = 81) Placebo (n = 79) 24 28 Study Week \* \* \* \* \* \* \* \* \* \*\* \*Nominal P < 0.05 \*\* P < 0.001 Separation between brepocitinib 30 mg and placebo at all time points, starting as early as week 4, achieved together with substantially greater steroid reduction in brepocitinib 30 mg arm 46.5 37.5 31.2 Primary Endpoint 30 mg vs. Placebo At Week 52 TIS∆ 15.3 P = 0.0006 15 Brepocitinib 30 mg Placebo Mean dose at baseline (mg/day) 12.2 11.3 ≤2.5 mg/day by week 48-52 62% 34% Off steroids by week 48-52 42% 23% Steroid reduction among patients on background OCS For investor audiences only

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CONFIDENTIAL 46% 29% 26% >2/3 of Patients on 30 mg Achieved Moderate TIS Response (TIS40) & Nearly Half Achieved Major TIS Response (TIS60) Patients Achieving Moderate TIS Response (TIS40) at Week 52 Patients Achieving Major TIS Response (TIS60) at Week 52 68% 54% 44% Brepocitinib 30 mg (n = 81) Brepocitinib 15 mg (n = 81) Placebo (n = 79) Brepocitinib 30 mg (n = 76) Brepocitinib 15 mg (n = 77) Placebo (n = 72) Adjusted response rate (risk) differences calculated using the Mantel-Haenszel method. 16 For investor audiences only ∆ P 30 mg vs. Placebo 22.2% 0.0040 15 mg vs. Placebo 11.6% 0.1420 ∆ P 30 mg vs. Placebo 19.5% 0.0126 15 mg vs. Placebo 6.2% 0.3920

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CONFIDENTIAL Brepocitinib 30 mg Resulted in High Rates of Clinically Meaningful Improvement 68% 58% 46% 38% 0% 10% 20% 30% 40% 50% 60% 70% Cross-Trial Comparison of TIS Responder Rates At Similar Timepoints TIS40 Response Rate TIS60 Response Rate ProDERM – Week 40 Open-Label VALOR – Week 52 Placebo-Controlled Aggarwal et al, NEJM 2022 ProDERM – Week 40 Open-Label VALOR – Week 52 Placebo-Controlled Brepocitinib 30 mg (n = 81) Octagam (IVIg) (n = 45)1 Disclaimer: 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. 1) 17 For investor audiences only

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CONFIDENTIAL 36% 20% 9% 54% 41% 27% More Than A Third of Brepocitinib 30 mg Patients Achieved Both Major TIS Response And Minimal or No Steroid Burden At Week 52 \*Nominal p-value calculated as part of post-hoc analysis Adjusted response rate (risk) differences calculated using the Mantel-Haenszel method. Patients Achieving Moderate TIS Response (TIS40) with Oral Steroids ≤2.5 mg/day at Week 52 Patients Achieving Major TIS Response (TIS60) with Oral Steroids ≤2.5 mg/day at Week 52 Brepocitinib 30 mg (n = 81) Brepocitinib 15 mg (n = 81) Placebo (n = 79) Brepocitinib 30 mg (n = 81) Brepocitinib 15 mg (n = 81) Placebo (n = 79) 18 For investor audiences only ∆ P 30 mg vs. Placebo 25.7% 0.0006 15 mg vs. Placebo 13.0% 0.0851 ∆ P 30 mg vs. Placebo 27.1% <0.0001\* 15 mg vs. Placebo 12.0% 0.0289\*

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CONFIDENTIAL Time Course of CDASI-Activity Change from Baseline Statistically significant, clinically meaningful separation between brepocitinib 30 mg and placebo at all time points, starting as early as week 4 Brepocitinib 30 mg (n = 81) Brepocitinib 15 mg (n = 81) Placebo (n = 79) -14 -12 -10 -8 -6 -2 -4 0 0 4 8 12 16 20 32 36 40 44 48 52 Study Week 24 28 Mean CFB in CDASI-A (± SE) \*Nominal P < 0.05 \*\* P < 0.001 \* \* \* \* \* \* \* \* \*\* \*\* -7.0 -9.4 -11.7 19 For investor audiences only

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CONFIDENTIAL Brepocitinib 30 mg Achieved Meaningful Cutaneous Improvement in Subjects with Moderate-to-Severe Skin Disease at Baseline Ns for subjects with moderate-to-severe skin disease at baseline: brepocitinib 30 mg n = 46; placebo n = 53 \*Nominal p-value calculated as part of post-hoc analysis CDASI-A: Cutaneous Dermatomyositis Activity and Severity Index - Activity Subscore Mean Percent Reduction in CDASI-A by Week 52 Subjects with baseline CDASI-A > 14 Portion of Patients Achieving Cutaneous Clinical Remission by Week 52 (CDASI-A ≤ 5) Subjects with baseline CDASI-A > 14 Highly morbid, often treatment-resistant population representing significant share of DM patients 44% 21% 30 mg vs. Placebo: ∆ 26.6%; P=0.0060\* 63% 37% 30 mg vs. Placebo: ∆ 25.7%; P=0.0016\* 20 For investor audiences only

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CONFIDENTIAL Brepocitinib 30 mg Demonstrated Substantial Evidence of Improvement on Muscle Disease Across Multiple Endpoints Motor Strength Confirmed Benefit on MMT-8 with Brepocitinib 30 mg vs. Placebo Global Benefit Substantial Improvement on TIS in Patients with Moderate-to-Severe Muscle Disease at Baseline +17 points vs. Placebo in patients with MMT-8 < 136 at baseline1 Functional Muscle Improvement HAQ-Disability Index Achieved Clinical and Statistical Significance 13.5 vs. 8.7 ∆ 4.8, P=0.042 -.30 points vs. Placebo, P = 0.0035 72% on brepocitinib 30 mg achieved 7-point increase3, compared to 54% on placebo 72% on brepocitinib 30 mg achieved TIS40 in this subgroup, versus 46% on placebo 49% on brepocitinib 30 mg achieved the MCID of at least -0.3, compared to 29% on placebo 1. 2. 3. Based on a post-hoc analysis Nominal P value 7-point change on the MMT-8 score represents 1 category of muscle disease activity (i.e., moderate vs. mild disease). MCID: Minimum clinically important difference 21 For investor audiences only

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CONFIDENTIAL Brepocitinib 30 mg Achieved Rapid Onset Of Action, With Confirmed Benefit As Early As Week 4 Rapid onset of action consistent with TYK2/JAK1 mechanism of action Rapid Statistically Significant Separation From Placebo Rapid Achievement of Clinical Improvement Thresholds Week 4 Time to achieve statistically significant separation on both TIS\* and CDASI-A for brepocitinib 30 mg vs. placebo 32 days Median Time to TIS20 61 days Median Time to TIS40 TIS: Total Improvement Score; CDASI-A: Cutaneous Dermatomyositis Activity and Severity Index - Activity Subscore \*Based on nominal p value. 22 For investor audiences only

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CONFIDENTIAL Key Endpoint Important Features Brepocitinib 30mg (n=81) Placebo (n=79) P-Value Mean TIS (Primary) Composite endpoint, focus on muscle disease and global benefit 46.5 31.2 0.0006 CDASI-A change from baseline at Week 52 Improvement in skin disease activity -11.7 -7.0 0.0006 DMOMS at Week 52 DM-specific muscle and skin composite measure of benefit 57.9 40.5 0.0014 TIS40 Response at Week 52 Moderate TIS response (focus on global benefit / muscle) 67.9% 44.3% 0.0040 Time to Consecutive TIS40 Response by Week 52 Time to onset of sustained benefit (particularly high bar) 85 days 168 days 0.0155 Patients achieving TIS40 Response + ≤2.5 mg OCS at Week 52 Achievement of clinical response and steroid reduction 54.3% 26.6% 0.0006 CDASI-A 40% Response with ≥4- point improvement at Week 52 Clinically meaningful skin response 61.7% 44.3% 0.0357 TIS60 Response at Week 52 Major TIS response – Highest TIS response threshold 46.1% 26.4% 0.0126 Change from baseline in HAQ-DI at Week 52 Improvement in physical and functional disability and daily living activities related to muscle strength -0.337 -0.042 0.0035 Change from baseline in CDASI-A at Week 4 Rapid onset of skin response -6.4 -3.5 0.0003 Brepocitinib 30 mg Achieved Statistically Significant Benefit On All Ten Ranked Endpoints Measurements of skin disease, muscle disease, rapidity of onset, and steroid sparing; consistent dose response was also seen across endpoints 23 For investor audiences only

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CONFIDENTIAL Overview of Safety Events Brepocitinib 30 mg QD (N=81) Brepocitinib 15 mg QD (N=81) Placebo (N=79) Participants with: AEs 73 (90%) 70 (86%) 72 (91%) Death 0 0 0 SAEs 13 (16%) 7 (9%) 10 (13%) AEs leading to treatment discontinuation 5 (6%) 6 (7%) 9 (11%) AEs leading to study discontinuation 3 (4%) 4 (5%) 3 (4%) Adverse Events of Special Interest: Cardiovascular events 1 (1%) 0 2 (3%) Thromboembolic events 0 0 1 (1%) Viral reactivation 4 (5%) 2 (2%) 4 (5%) Opportunistic infections 0 0 0 New or recurrent diagnoses of malignancy 0 0 2 (3%) Increase in ALT or AST 1 (1%) 2 (2%) 1 (1%) Abbreviations: AE=adverse event, ALT=alanine aminotransferase, AST=aspartate aminotransferase, SAE=serious adverse event. Note: Percentages are based on the number of unique participants with an event out of the column total. Treatment-emergent AEs are reported. . Adverse events of special interest balanced across treatment arms; no new safety signals for brepocitinib Brepocitinib safety database includes over 1,500 patients and subjects, with a safety profile that appears consistent with approved JAK inhibitors 24 For investor audiences only

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CONFIDENTIAL Statistically and clinically significant improvement in skin disease Statistically and clinically significant improvement in muscle disease Breadth of Response High TIS response rates even while aggressively tapering steroids Functional remission of skin disease achieved in nearly half of subjects with moderate-to-severe disease at baseline Depth of Response Confirmed benefit on TIS and CDASI as early as week 4 Median Time to TIS40 of 8 weeks Speed of Response Nearly all DM patients can potentially benefit from brepocitinib Significant fraction of patients can potentially achieve deep, clinically meaningful responses Patients can potentially achieve rapid improvement in symptoms in as few as 4 weeks Observed Results in VALOR Implication for Patients VALOR Results Confirm Brepocitinib's Potential to Meaningfully Improve the Lives of Patients with DM Results achieved with a convenient once-daily oral therapy TIS: Total Improvement Score CDASI-A: Cutaneous Dermatomyositis Activity and Severity Index - Activity Subscore 25 Safety database of >1,500 patients Adverse events of special interest balanced across treatment arms; no new safety signals for brepocitinib Safety Potentially favorable benefit:risk profile for patients For investor audiences only

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Upcoming Roivant Investor Day Thursday, December 11th, 2025 In-Person Details to follow

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Q&A

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Appendix

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Dermatomyositis: Disease Overview Literature-Based Estimates Priovant Claims Analysis Other Companies Developing DM Therapies 23K1 70K 40K 52K2 51K Dermatomyositis is a chronic inflammatory disease of the skin and muscles that affects approximately 40-50K US adults US ADULT PREVALENCE 29 For investor audiences only 37K INCIDENCE Literature-Based Estimates 1.1/100, 0003 3.0/100, 0004 1. 2. 3. 4. Smoyer-Tomic et al, BMC Musculoskeletal Disorders (2012) Reeder et al, Arch Dermatol (2010) Kronzer et al, Arth Care Res (2021) Osman et al, Sci Reports (2023) Priovant Claims Analysis 2.2/100,000 1.4/100,000

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30 For investor audiences only Brepocitinib: Other Details ROIV owns 74%1 of Priovant, with Pfizer owning 25%. Ownership Geographic Rights Intellectual Property Milestones Royalties As of June 30, 2025. 65% on a fully diluted basis. Includes potential patent term extension We expect Brepocitinib to have US exclusivity at least until 20392. Priovant has commercial rights to brepocitinib in US and Japan. Priovant is obligated to pay Pfizer mid tens-of-millions if sales exceed a mid hundreds-of-millions amount in Priovant territories. Pfizer is obligated to pay Priovant low tens-of-millions if sales exceed a mid hundreds-of-millions amount in non-Priovant territories. Priovant is obligated to pay Pfizer tiered sub-teens royalties on annual sales in Priovant territories. Pfizer is obligated to pay Priovant tiered high single digits to sub-teens royalties on annual sales in non-Priovant territories.

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31 For investor audiences only Speaker Biographies Matthew Gline Matt Gline serves as Chief Executive Officer of Roivant Sciences. Mr. Gline joined Roivant in March 2016 and previously served as Chief Financial Officer. From April 2014 to March 2016, he was a Vice President at Goldman Sachs, Fixed Income Digital Structuring, where he focused on technology and data strategy. Prior to Goldman Sachs, Mr. Gline was a co-founder of Fourthree, a risk analytics technology and consulting company. From 2008 to 2012, he served as Vice President at Barclays, Enterprise Risk Management Advisory, where he provided analysis for corporate clients related to capital markets access for financing and risk management. Mr. Gline earned his A.B. in Physics from Harvard College. Benjamin Zimmer Ben Zimmer has been CEO of Priovant since the company's creation in 2021. Prior to joining Priovant he served on the leadership team of Roivant as acting COO (2018-2019) and President, Roivant Health (2018-2021). In this role, Ben led the incubation, launch, and board oversight of Datavant (majority stake acquired by New Mountain Capital), Sinovant (included in Roivant-DSP transaction), and VantAI. From 2015-2018, Ben worked at Roivant in a variety of roles across business operations, clinical operations, and public affairs. Before Roivant, Ben founded and ran a public policy-focused non-profit and worked as a consultant at McKinsey. He holds an A.B. in History from Harvard College and a J.D. from Yale Law School.

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Thank you.

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