Summary of Roivant Sciences FY Conference Call (March 03, 2026) Company Overview - **Company**: Roivant Sciences (NasdaqGS:ROIV) - **Event**: 46th Annual TD Cowen Healthcare Conference Key Points PDUFA Date and Drug Launch - The PDUFA date for Roivant's therapy is set for the third quarter of 2026, with a planned launch by the end of September 2026 [6][8] - The company received a priority review from the FDA, indicating confidence in the therapy's data quality [10] Market Expectations and Physician Feedback - Surveys indicate that physicians expect a 30% market share for the new therapy, which aligns with historical accuracy of such surveys [12][13] - There is significant excitement among physicians regarding the potential to reduce steroid burden for patients [16] Treatment Landscape - Approximately 75% of the 40,000 patients tracked are currently managed with DMARDs and oral steroids, while 25% are on IVIG or off-label treatments [17][18] - The new therapy is expected to attract patients dissatisfied with current treatments, particularly those with high steroid burdens [19][20] Efficacy and Labeling - The therapy is anticipated to have a broad indication for dermatomyositis, aiming to serve a wide patient population [13][14] - The study included a steroid taper, and the company plans to provide extensive information on managing steroid reduction [15] Clinical Trials and Data - The NEPTUNE study showed a 29% relapse rate at the 45 mg dose, significantly better than Humira's 62% [23] - The CLARITY studies are designed to mirror NEPTUNE, with a focus on steroid tapering [24][26] Future Studies and Approvals - The company is preparing for phase 3 studies based on positive phase 2 data, with discussions ongoing with the FDA regarding trial design [48][49] - The goal is to maintain consistency with successful phase 2 data in future studies [49] Mosliciguat and Other Programs - Mosliciguat is being studied for pulmonary hypertension with promising phase 1 data showing significant peripheral vascular resistance reduction [61] - The phase 2b PHOCUS study is expected to read out data in the second half of the year, focusing on PVR and six-minute walk metrics [62][64] IMVT-1402 for Graves' Disease - Data from the FORWARD studies for Graves' disease is expected next year, with a focus on controlling refractory patients [82][83] - The therapy aims to provide a new treatment option for patients who are currently uncontrolled on antithyroid drugs (ATDs) [82][84] Legal Matters - Ongoing litigation with Moderna regarding intellectual property, with the company feeling confident about its position [92][93] Additional Insights - The company is focused on addressing the needs of patients who are currently dissatisfied with existing therapies, particularly in underdeveloped treatment landscapes [20][73] - There is a strong emphasis on the importance of patient comfort and the potential for new therapies to improve quality of life [70][72]

Core Thesis - United Therapeutics Corporation is positioned for growth driven by its lead product treprostinil, which is used in treating pulmonary arterial hypertension (PAH) and is expanding into idiopathic pulmonary fibrosis (IPF) [2][3] Company Overview - United Therapeutics is a commercial-stage biotechnology company focused on treprostinil, a prostacyclin analogue, with multiple delivery platforms including Tyvaso, Tyvaso DPI, Remodulin, and Orenitram [2] - The company has established a profitable franchise in PAH and pulmonary hypertension-associated interstitial lung disease (PH-ILD) [2] Growth Drivers - The expansion of Tyvaso into idiopathic pulmonary fibrosis represents a significant growth opportunity, addressing a larger patient population with high unmet medical needs [3] - The ex-US TETON-2 Phase 3 trial has successfully met its primary endpoint, indicating potential anti-fibrotic benefits of treprostinil [3] - The ongoing TETON-1 study in the US and Canada is critical for supporting a supplemental New Drug Application (NDA) and could expand the addressable market to approximately 100,000 patients in the US [3] Financial Position - United Therapeutics has over $4 billion in cash and investments, with strong annual operating cash flow exceeding $1.3 billion, indicating a robust financial position [4] - The company does not rely on external financing, allowing it to absorb litigation risks and fund research and development initiatives [4] Competitive Landscape - While there is competitive pressure from companies like Liquidia, United Therapeutics' multi-modal platform and established patient support infrastructure provide a competitive advantage [5] - The TETON-1 trial is seen as a pivotal moment for the company, with a strong core franchise offering downside protection [5] Market Performance - As of January 15th, United Therapeutics' shares were trading at $471.99, with trailing and forward P/E ratios of 17.89 and 15.15 respectively [1]

Liquidia R&D Day Webcast presentation October 28, 2025 ©2025 LIQUIDIA CORPORATION ALL RIGHTS RESERVED Forward-looking statements This presentation includes, and our response to questions may include, forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 ("PSLRA"). All statements contained in this presentation other than statements of historical facts, including statements regarding our future results of operations and financial position, our strategic and fina ...

Company Overview - United Therapeutics (UTHR) shares increased by 3.5% to close at $286.14, following a period of decline where the stock lost 7.7% over the past four weeks [1] - The rise in share price is linked to a recovery after a decline due to positive results from a pulmonary arterial hypertension (PAH) study conducted by Insmed, which evaluated a prodrug formulation of UTHR's treprostinil [2] Financial Performance - United Therapeutics is expected to report quarterly earnings of $6.87 per share, reflecting a year-over-year increase of 17.4% [3] - Revenue projections for the upcoming quarter stand at $796.42 million, which is an 11.4% increase compared to the same quarter last year [3] Earnings Estimates and Market Sentiment - The consensus EPS estimate for United Therapeutics has been revised 0.7% higher in the last 30 days, indicating a positive trend that typically correlates with stock price appreciation [4] - The company currently holds a Zacks Rank of 3 (Hold), suggesting a neutral outlook in the market [4] Industry Context - United Therapeutics operates within the Zacks Medical - Drugs industry, where BioCryst Pharmaceuticals (BCRX) is another player, having closed 2% lower at $10.40 [4] - BioCryst's consensus EPS estimate remains unchanged at $0.02, representing a significant year-over-year change of 133.3% [5]