Roivant Sciences(ROIV) - 2025 Q4 - Earnings Call Transcript

Financial Data and Key Metrics Changes - The company reported just under $5 billion in cash on the balance sheet as of March 31, 2025, with no debt [11][35] - The net cash usage for the quarter was approximately$ 150 million, which is considered a normal quarter for the business [35] - The company has repurchased $1.3 billion of its own stock, reducing the share count by nearly 15% [11][35] Business Line Data and Key Metrics Changes - The company is focused on multiple late-stage pipeline products, including brevacitinib and IMG1402, with significant clinical execution and progress across all main clinical franchises [7][8] - Brevacitinib is expected to be a market therapy within the next couple of years, with pivotal studies ongoing in multiple indications [8][12] - The company has initiated studies in dermatomyositis and cutaneous sarcoidosis, with data readouts expected in the near future [14][18] Market Data and Key Metrics Changes - The company is addressing a patient population with high unmet needs, particularly in dermatomyositis, where the only approved therapy is IVIG [40] - The estimated market for dermatomyositis is between 40,000 to 70,000 patients in the U.S., with approximately 34,000 currently treated [100] Company Strategy and Development Direction - The company aims to capitalize on its strong cash position to drive profitability and pipeline expansion, with$ 2 billion reserved for future opportunities [11][12] - The focus is on indications with high unmet needs and potential for first-in-class therapies, particularly in the FcRn space [19][88] - The company is preparing for a busy data generation period over the next 36 months, with multiple potential blockbuster launches anticipated [10][31] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming data readouts and the potential for significant market opportunities, particularly in immunology [10][31] - The company acknowledges the challenging market environment but feels well-positioned compared to peers [12][35] - Management emphasized the importance of capital allocation and the strategic focus on high unmet medical needs [11][12] Other Important Information - The company is in the summary judgment phase of its LNP litigation against Moderna and Pfizer, with a trial expected to follow [32][34] - The company is also awaiting a ruling in the Pfizer case, which is anticipated later this year [51] Q&A Session Summary Question: What are the expectations for the DM study? - Management indicated that a positive study with statistically significant separation from placebo is necessary for success in the DM study [39][40] Question: Can you provide an update on the LNP litigation against Moderna? - Management noted that narrowing the case is a normal part of patent litigation and that parameters will be evident in the near future [43][44] Question: What is the status of the pending Pfizer Markman decision? - Management stated that the timing of the Markman decision is at the judge's discretion and is hopeful for a ruling later this year [51] Question: How is the company planning to position Brevacitinib if approved? - Management views the entire market as addressable and believes many patients represent low-hanging fruit due to the lack of options [60] Question: What are the expectations for the placebo response in the DM study? - Management referenced published data from similar studies that showed a well-behaved placebo response, which is encouraging [70] Question: What is the observable population for dermatomyositis in the U.S.? - Management estimates the DM market to be between 40,000 to 70,000 patients, with around 34,000 currently treated [100]