PresentationMatthew GlineCEO & Director Yes. Thanks for having us. I'm very aware there's like a large 40-minute timer here that's counting down slowly. So I'm aware of the time to fill. We have a lot to say, though. So look, I'm the CEO of Roivant. We are a biopharma company. I think most are probably at least somewhat familiar with us. We mostly focus on development-stage drug development, clinical stage drug development. And today, we have a portfolio of several quite late-stage clinical programs, one of ...

Group 1 - The discussion revolves around the interpretation of recent data and its implications for patients and doctors in the context of DM (disease management) [2] - There is a focus on the importance of understanding the results and how they can influence medical practice and patient care [2] - The conversation highlights the initial nervousness regarding placebo effects but suggests a sense of relief now that the desired results have been achieved [1]

Summary of Roivant Sciences Conference Call Company Overview - **Company**: Roivant Sciences (NasdaqGS:ROIV) - **Event**: BofA Global Healthcare Conference - **Date**: September 24, 2025 Key Points Industry Context - **Focus Area**: Dermatomyositis (DM) and related therapies - **Significance**: The DM treatment landscape has historically been challenging, with many drugs failing to achieve regulatory approval. The introduction of a novel therapy, BREPO, marks a significant advancement in this field [6][7][8]. BREPO Data and Implications - **Clinical Data**: The recent data from the BREPO study is viewed as a major breakthrough for the DM community, providing hope for patients who have limited treatment options [6][7]. - **Patient Impact**: BREPO offers a once-daily oral alternative to cumbersome IVIG treatments, which are difficult for patients to manage alongside their daily lives [7][8]. - **Steroid Reduction**: The study demonstrated a meaningful benefit in reducing steroid dosages for patients, which is crucial given that 75% of DM patients are treated with steroids and immunosuppressants [8]. Adoption and Market Strategy - **Adoption by Clinicians**: It is anticipated that clinicians will initially prescribe steroids and immunosuppressants before considering BREPO as a treatment option. Patients on high doses of steroids are likely to seek alternatives [10][11]. - **Target Patient Population**: Approximately 35,000 to 40,000 patients with DM are currently treated, many of whom may be eligible for BREPO [11]. - **Market Approach**: The launch strategy focuses on building strong relationships with a concentrated group of 200 referral centers, emphasizing medical engagement over traditional promotional methods [21][22]. Future Pipeline and Indications - **Additional Indications**: Roivant is studying BREPO in other indications, including non-infectious uveitis and cutaneous sarcoidosis, with plans for further exploration in rare disease settings [25][26]. - **Intellectual Property**: The company holds patent extensions for BREPO through 2039, providing a solid foundation for future development [25]. Competitive Landscape - **Market Position**: Roivant believes it occupies a unique position in the JAK inhibitor market, particularly in rare and orphan diseases, with limited direct competition in the late-stage development of JAK1/TYK2 dual inhibitors [29][30]. Regulatory Considerations - **FDA Engagement**: Discussions with the FDA regarding dosing for non-infectious uveitis have been positive, with a focus on achieving effective outcomes for patients with severe conditions [31][34]. Challenges and Considerations - **Market Dynamics**: The company acknowledges the challenges faced by previous therapies in the DM space and aims to differentiate BREPO through compelling clinical data and patient support initiatives [21][22]. - **Long-term Treatment Plans**: The approach to treatment duration will vary by patient, with some potentially requiring long-term therapy based on their individual responses [46][48]. Conclusion - Roivant Sciences is positioned to make a significant impact in the treatment of dermatomyositis and related conditions with the introduction of BREPO, supported by strong clinical data and a focused market strategy. The company is also exploring additional indications and maintaining a robust intellectual property portfolio to support future growth.

Core Viewpoint - Momentum investing focuses on following a stock's recent price trends, aiming to buy high and sell higher, with the expectation that established trends will continue [1] Company Summary: Roivant Sciences Ltd. (ROIV) - Roivant Sciences Ltd. has a Momentum Style Score of B, indicating potential for solid momentum investing [2] - The company currently holds a Zacks Rank of 2 (Buy), suggesting it is positioned for outperformance in the market [3] - Over the past week, ROIV shares have increased by 6.82%, while the Zacks Medical - Biomedical and Genetics industry remained flat [5] - In a longer timeframe, ROIV shares have risen by 28.35% over the past month, significantly outperforming the industry's 1.27% [5] - Over the last quarter, ROIV shares increased by 32.56%, and over the past year, they gained 25.55%, compared to the S&P 500's 12.64% and 18.69% respectively [6] - The average 20-day trading volume for ROIV is 8,748,874 shares, indicating a bullish sign as the stock is rising with above-average volume [7] Earnings Outlook - Recent earnings estimate revisions show one upward revision for the current fiscal year, raising the consensus estimate from -$1.11 to -$1.09 [9] - For the next fiscal year, two estimates have moved upwards with no downward revisions, indicating positive sentiment [9] Conclusion - Considering the positive momentum indicators and earnings outlook, ROIV is a 2 (Buy) stock with a Momentum Score of B, making it a strong candidate for near-term investment [11]

Company Overview - Roivant Sciences (NASDAQ:ROIV) is a biopharmaceutical company focused on developing transformative medicines [1] - The company has a market capitalization of approximately $10.23 billion [5] Stock Performance - On September 18, 2025, Citigroup adjusted its rating for Roivant to Neutral, maintaining a hold action, with the stock price at $15.47 [1] - Bank of America raised its price target for Roivant from $12 to $16.50 [1] - Currently, ROIV's stock price is $14.99, reflecting a decrease of approximately 1.93% or $0.30 [4] - Over the past year, ROIV has reached a high of $16.05 and a low of $8.73 [5] - Today's trading volume for ROIV is 2,323,718 shares, indicating active investor interest [5] Clinical Study Results - Roivant announced positive results from its Phase 3 VALOR study, which evaluated brepocitinib for treating dermatomyositis (DM) [2][6] - The study showed that a 30 mg daily dose of brepocitinib led to significant improvements compared to a placebo, achieving a week 52 mean Total Improvement Score (TIS) of 46.5 versus 31.2 for the placebo group [3] - The p-value of 0.0006 indicates strong statistical significance, with more than two-thirds of patients on the 30 mg dose experiencing at least a moderate response, and nearly half achieving a major response [3] Future Plans - Roivant plans to file a New Drug Application (NDA) in the first half of 2026, following the consistent safety profile of brepocitinib [4][6] - The company will also host an investor call to discuss the findings from the VALOR study [4]

Company Overview - Roivant Sciences Ltd. (ROIV) shares increased by 7.8% to $15.28 in the last trading session, with a notable trading volume, and have gained 20.6% over the past four weeks [1][2] Clinical Development - Roivant, in partnership with Priovant Therapeutics, announced that their investigational candidate brepocitinib met the primary and all nine key secondary endpoints with statistical significance in the phase III VALOR study for dermatomyositis (DM) [2] - Brepocitinib demonstrated rapid, durable, and broad improvements in skin and muscle disease, along with a safety profile consistent with prior studies, marking a significant milestone as the first positive outcome for a 52-week placebo-controlled study in DM [2] Financial Expectations - The company is projected to report a quarterly loss of $0.26 per share, reflecting a year-over-year change of +10.3%, with expected revenues of $6.24 million, up 39.5% from the previous year [3] - Trends in earnings estimate revisions are correlated with near-term stock price movements, indicating potential strength in ROIV's stock [3][4] Industry Context - Montes Archimedes Acquisition, part of the same industry as Roivant, has seen its consensus EPS estimate remain unchanged, suggesting that stock price movements may not continue without earnings estimate trends [4] - ADC Therapeutics SA, another company in the biomedical and genetics industry, has a consensus EPS estimate of -$0.37, representing a year-over-year change of +11.9% [5]

Core Points - The conference call is focused on the VALOR Phase III study results conducted by Roivant Platforms [2] - Key executives presenting include Stephanie Lee, Matt Gline, and Ben Zimmer, indicating a collaborative effort in the presentation of the study results [2] - The presentation includes slides and a press release available on the company's investor relations website, emphasizing transparency and accessibility of information [2][3] Presentation Details - The call is being recorded, which suggests that the information shared will be documented for future reference [1] - Forward-looking statements will be made during the presentation, highlighting the company's commitment to providing insights into future expectations and developments [3] - The presentation will include slide numbers to assist participants in following along, indicating a structured approach to the information being shared [3]

Market Overview - The S&P 500 Index is down -0.17%, while the Dow Jones Industrials Index is up +0.77%, and the Nasdaq 100 Index is down -0.80% [1] - Weakness in chipmakers, particularly Nvidia, which is down more than -2%, is impacting the broader market due to regulatory actions from China's Cyberspace Administration [2][11] - The overall market is negatively affected by the decline in major technology stocks, with Amazon, Tesla, and Meta Platforms all down more than -1% [12] Economic Indicators - US housing news showed weaker-than-expected results, with August housing starts falling -8.5% month-over-month to 1.307 million, below expectations of 1.365 million [3] - Building permits also fell unexpectedly by -3.7% month-over-month to a 5.25-year low of 1.312 million, against expectations of an increase [3] - MBA mortgage applications rose +29.7% in the week ended September 12, with refinancing applications up +57.7% [4] Federal Reserve Actions - The Federal Reserve approved a quarter-percentage-point rate cut and indicated two additional cuts are expected before the end of the year due to concerns over the labor market [1][5] - The market anticipates a total of about 70 basis points in rate cuts by year-end, with a focus on the Fed's new economic forecasts [5] Company-Specific Developments - Uber Technologies is down more than -4% following insider selling by CEO Khosrowshahi, who sold $28.6 million in shares [13] - Manchester United reported a Q4 loss and cut its 2026 revenue outlook, leading to a decline of more than -6% in its stock [12] - Roivant Sciences is up more than +12% after its drug met primary endpoints in a Phase 3 trial [14] - Workday is up more than +8% after an upgrade from Guggenheim Securities [14] - Walmart is up more than +2% following a price target increase from Bank of America [15]

Core Insights - Roivant Sciences Ltd and Priovant Therapeutics announced positive results from the Phase 3 VALOR study for brepocitinib in treating dermatomyositis, marking a significant advancement in targeted therapy for this chronic autoimmune disorder [1][4]. Group 1: Study Results - Brepocitinib 30 mg showed a statistically significant improvement on the primary endpoint with a week 52 mean Total Improvement Score (TIS) of 46.5 compared to 31.2 for placebo (p=0.0006) [2][3]. - The treatment demonstrated clinically meaningful improvements across all nine key secondary endpoints, including skin and muscle disease metrics, steroid-sparing effects, and rapidity of onset [2][4]. Group 2: Patient Background and Outcomes - Approximately 75% of patients in the VALOR study were on background steroids, with a mean baseline dose of 12.2 mg/day in the brepocitinib group and 11.3 mg/day in the placebo group [5]. - Among those on steroids, 62% of brepocitinib patients reduced their steroid dose to ≤2.5 mg/day by the end of the study, compared to 34% for placebo, and 42% of brepocitinib patients were able to discontinue steroids entirely, versus 23% for placebo [5]. Group 3: Safety and Future Plans - The safety profile of brepocitinib 30 mg was consistent with previous clinical trials, indicating a favorable safety outcome [6]. - Priovant plans to file a New Drug Application (NDA) for brepocitinib in dermatomyositis in the first half of 2026 [6].

Group 1: Stock Market Overview - U.S. stocks exhibited mixed performance, with the Dow Jones index increasing by over 200 points on Wednesday [1] Group 2: Notable Stock Movements - Lyft, Inc. shares surged by 13.5% to $22.92 following the announcement of an expansion plan with Waymo to Nashville, where Lyft's Flexdrive will manage Waymo's fully autonomous vehicles [1] - New Fortress Energy Inc. saw its shares jump 32.3% to $2.6501 after securing a long-term gas supply agreement with the Puerto Rican government [3] - Oruka Therapeutics, Inc. experienced a 14.1% increase in shares to $17.01 after announcing interim Phase 1 results for ORKA-001 and a $180 million private placement [3] - Robo.ai Inc. shares rose by 12.9% to $1.9190 [3] - Roivant Sciences Ltd. gained 12% to $15.89 after reporting Phase 3 results for brepocitinib in treating a debilitating skin-muscle disease [3] - Opendoor Technologies Inc. shares surged by 11.1% to $9.91 [3] - Gevo, Inc. also gained 11.1%, reaching $2.1089 [3] - Blue Gold Limited saw a 10.5% increase to $11.05 [3] - Workday, Inc. shares surged by 9% to $238.63 after an upgrade from Piper Sandler, raising the price target from $220 to $235 [3] - Parsons Corporation gained 6.9% to $80.64 after being awarded a task order for Indo-Pacific Counter-Nuclear Smuggling System Deployment [3] - e.l.f. Beauty, Inc. shares increased by 4.6% to $149.91, with B of A Securities maintaining a Buy rating and raising the price target from $135 to $160 [3]