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.

Financial Data and Key Metrics Changes - The company reported an adjusted net loss of $170 million for the quarter, with cash utilization of approximately $200 million outside of the share repurchase program [25][26] - The balance sheet remains strong with $4.5 billion in cash and no debt, alongside a significantly reduced share count due to the share repurchase program [25][26] Business Line Data and Key Metrics Changes - The company is focused on the development of IVT-1402 and Immunovant, aiming to establish a best-in-class anti-FcRn antibody [6] - The registrational data for brepcitinib in dermatomyositis is expected in the second half of the year, which is crucial for the commercial launch of the drug [6][19] - The company has multiple ongoing registrational trials, with five trials for IVT-1402 currently in progress [9] Market Data and Key Metrics Changes - The company is preparing for a pivotal trial in Graves' disease, with expectations for significant data to be released soon [19][27] - The competitive landscape includes multiple programs from other companies, but the company believes its oral therapy will provide a unique advantage [19][96] Company Strategy and Development Direction - The company aims to expand its commercial footprint significantly over the next few years, starting with pivotal data in dermatomyositis and subsequent launches across its FcRn portfolio [10][19] - The company is actively engaging in business development, looking for transformational late-stage opportunities, particularly in the current choppy market [48][54] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the upcoming data and its potential impact on the company's commercial strategy, particularly in Graves' disease [27][76] - The company is focused on ensuring successful clinical execution and is confident in its ability to meet timelines for upcoming trials [71][72] Other Important Information - The company completed a $1 billion share repurchase program, reducing its share count by over 15% [10] - An additional $500 million repurchase program has been authorized for opportunistic use as market conditions fluctuate [10] Q&A Session Summary Question: Data availability at the time of top line results for brepcitinib - Management expects to have top line and key secondary data available contemporaneously with the results, with a potential filing for approval at the beginning of next year [29][31] Question: Trial design for the Graves' disease study - The rationale for testing a lower dose in the second Graves' trial is to ensure FDA approval and advocate for a minimally efficacious dose [32][33] Question: Definition of a flare in the trial - Management indicated that the definition of a flare and treatment protocols are designed to ensure accurate identification of patients who are worsening [35][38] Question: Context around upcoming Graves' remission data - Any amount of meaningful remission would be considered practice-changing for doctors treating Graves' disease patients [44][45] Question: Business development outlook - The company remains opportunistic in its business development strategy, particularly in the current market environment [48][54] Question: Enrollment status for ongoing studies - Enrollment for IVT-1402 trials is on track, with the team actively engaged and enthusiastic about the indications [70][71] Question: Importance of upcoming data at ATA - The data is expected to highlight the transformative potential of the drug for Graves' patients, which could significantly impact enrollment and physician enthusiasm [75][76] Question: Roadmap for pivotal development and potential filing year for NIU - The company is on track to generate data for NIU in 2027, with plans for a supplemental NDA filing shortly thereafter [83][84]

Financial Data and Key Metrics Changes - The company reported an adjusted net loss of $170 million for the quarter, with cash utilization of approximately $200 million outside of the share repurchase program [23] - The balance sheet remains strong with $4.5 billion in cash as of June 30, 2025, and no debt [23] Business Line Data and Key Metrics Changes - The company is focused on the development of IVT-1402 and Immunovant, aiming to establish a best-in-class anti-FcRn antibody [5] - The registrational data for brepcitinib in dermatomyositis is expected to be released in the second half of the year, which is crucial for the commercial launch [5][6] - The company has completed a $1 billion share repurchase program, reducing the share count by over 15% [8][9] Market Data and Key Metrics Changes - The company is actively involved in ongoing litigation related to LNP technology with Moderna, with a trial scheduled for March 2026 [19] - The competitive landscape includes multiple programs targeting dermatomyositis, with the company positioned as the only oral therapy in late-stage development [17][92] Company Strategy and Development Direction - The company aims to expand its commercial footprint significantly over the next few years, starting with pivotal data in dermatomyositis [7] - The focus is on clinical execution and advancing multiple registrational trials, particularly for IVT-1402 and brepcitinib [10][11] - The company is looking for opportunistic business development opportunities, especially in a choppy market [46][52] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the upcoming data and its potential impact on the company's commercial strategy [24] - The management highlighted the importance of engaging with the physician community to ensure successful product launches [95] Other Important Information - The company is preparing for a potential launch in dermatomyositis and is actively engaging with the physician community [92][95] - The company has a robust pipeline with multiple ongoing registrational trials and is focused on clinical execution [10][68] Q&A Session Summary Question: Data availability at the time of top-line results for brepcitinib - Management expects to share top-line data along with key secondary and major safety data contemporaneously [28] Question: Trial design for the Graves trial and rationale for lower dose testing - The trial design aims to ensure FDA approval with a focus on a minimally efficacious dose [31] Question: Definition of a flare in the trial and treatment protocols - The management indicated that the definition of a flare and treatment protocols are designed to ensure accurate patient management [34][37] Question: Context around upcoming Graves remission data - Management emphasized that any meaningful remission would be practice-changing for patients and doctors [43] Question: Business development outlook and interest in the China market - The company is agnostic in its asset hunting and is actively exploring opportunities in the Chinese market [52] Question: Enrollment status for ongoing studies - Management reported that enrollment for IVT-1402 trials is on track and progressing well [68] Question: Importance of upcoming data presentation at ATA - The management aims to highlight the transformative potential of the drug for Graves' patients [72] Question: Roadmap for pivotal development and potential filing year for NIU - The company is on track to generate data for NIU by 2027, with plans for a subsequent filing [80]

Core Insights - STRATA Skin Sciences is working with CMS to obtain temporary codes for expanded reimbursement of its XTRAC excimer laser treatment, aiming for implementation as early as the 2026 rule cycle [2][3] - The American Medical Association has approved updates to CPT codes, expanding reimbursement eligibility for XTRAC treatments to include various inflammatory and autoimmune skin conditions effective January 1, 2027 [2] - STRATA's efforts could potentially triple the addressable patient population, benefiting over 30 million individuals with chronic skin conditions [3] Company Developments - STRATA has received significant support from legislators, patient advocacy groups, and academic leaders, reinforcing confidence in the efficacy of Excimer Laser therapy [4] - Recent peer-reviewed studies have confirmed the safety and effectiveness of combining 308-nm excimer laser therapy with JAK inhibitors for treating vitiligo, with one study showing a 100% overall response rate [5][6] - The company is involved in ongoing litigation against LaserOptek America, with the Federal District Court agreeing to add LaserOptek Korea as a defendant, indicating potential for significant damages [7][8] Product and Market Strategy - STRATA's XTRAC excimer laser is positioned as a leading drug-free option for treating skin conditions, with a focus on enhancing patient outcomes [4][9] - The company offers a unique Partnership Program that includes a fee per treatment cost structure, on-site training, and marketing support to promote its technologies [11] - STRATA's intellectual property portfolio includes patents for localized treatment methods, positioning the company for future growth in the dermatology market [9]

Core Viewpoint - AbbVie has received marketing approval from the European Commission for its drug Rinvoq to treat giant cell arteritis (GCA), marking the eighth approved indication for this medication [1][4]. Group 1: Rinvoq Approval and Clinical Data - Rinvoq (15 mg, once daily) is the first JAK inhibitor approved in the EU for GCA and the first oral advanced therapy for this condition [2]. - The approval was based on the phase III SELECT-GCA study, which demonstrated that 46% of GCA patients treated with Rinvoq achieved sustained remission compared to 29% in the placebo group [3]. Group 2: Financial Performance and Market Impact - Rinvoq generated sales of nearly $6 billion in 2024, reflecting a year-over-year increase of 50.4% due to ongoing label expansions [6]. - Combined sales of Rinvoq and AbbVie's other drug Skyrizi reached $17.7 billion in 2024, with expectations to exceed $31 billion by 2027 driven by market growth and new indications [8][9]. Group 3: Competitive Landscape - Rinvoq and Skyrizi have shown strong performance against other novel therapies in clinical studies, providing a competitive advantage in the market [8]. - Other JAK inhibitors, such as Pfizer's Xeljanz and Lilly/Incyte's Olumiant, are also present in the market, with Olumiant generating sales of $957.4 million and Xeljanz $1.17 billion in 2024 [10][11].