Sep 12, 2025 7:00 AM Eastern Daylight Time United Therapeutics to Feature Clinical Data Across its Commercial and Development Portfolio at the European Respiratory Society Congress Share Results of the successful phase 3 TETON-2 study of inhaled treprostinil in idiopathic pulmonary fibrosis will be presented in an oral presentation SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, today announced that recent rese ...

United Therapeutics Has Near-Perfect Composite Rating Decades of market research reveals that the market's biggest winners tend to have an RS Rating above 80 as they launch their biggest runs. Among its other key ratings United Therapeutics carries an 84 EPS Rating out of 99. It also boasts a terrific 96 Composite Rating. The Composite score combines five separate proprietary ratings into one. The best growth stocks have a Composite Rating of 90 or better. Additionally, it has a best-possible SMR Rating (sa ...

PresentationTerence FlynnEquity Analyst All right. Great. Thanks. I think we're going to get started here, but I'm Terence Flynn, the U.S. biopharma analyst at Morgan Stanley. Very pleased to be hosting United Therapeutics this afternoon. Today from the company, we have James Edgemond, the company's CFO and Treasurer; and Harry Silvers, Investor Relations team. Thank you both so much for being here. Just before we get started, for important disclosures, please see the Morgan Stanley research disclosure webs ...

Summary of United Therapeutics FY Conference Call (September 08, 2025) Company Overview - **Company**: United Therapeutics (NasdaqGS: UTHR) - **Industry**: Biopharmaceuticals, focusing on respiratory diseases and organ transplantation Key Points and Arguments Clinical Trial Results - **Teton 2 Clinical Trial**: Announced as the best pivotal clinical trial outcome for United Therapeutics and the most successful idiopathic pulmonary fibrosis (IPF) pivotal trial ever reported [2][3] - **Results**: Nebulized Tyvaso showed superiority over placebo with a change in absolute forced vital capacity (FVC) of 95.6 milliliters from baseline to week 52, with a p-value of less than 0.0001 [3] - **Secondary Endpoints**: Statistically significant improvements were observed in most secondary endpoints, with some trending in favor of Tyvaso [3] Regulatory Approvals - **FDA and EMA Approval**: United Therapeutics has received orphan designation for nebulized Tyvaso for IPF treatment, ensuring a competitive edge before other therapies can be approved [4] Commercial Strategy - **Market Opportunity**: Approximately 100,000 patients in the U.S. with IPF represent a multibillion-dollar market opportunity [15] - **Salesforce Strategy**: Plans to establish a dedicated IPF/ILD Salesforce, leveraging similarities in call points between ILD and IPF [16][20] - **Sales Team Expansion**: Potential for a separate sales team to address the IPF market, with considerations for scaling based on market analysis [21][22] Capital Allocation - **Share Repurchase Program**: Initiated a $1 billion share repurchase program based on shareholder feedback and confidence in the company's commercial strength [25][26] - **Investment Focus**: Prioritizing internal R&D, corporate development, and returning cash to shareholders as part of capital allocation strategy [25] Pipeline and Future Developments - **Xenotransplant Program**: Key milestones include the first in-human transplant study (EXPAND) and IND clearance for the thymokidney product [42][46] - **Facility Expansion**: Operational facility in Christiansburg, Virginia, with plans for additional facilities in Minnesota and Texas, each with a capacity of approximately 125 organs per year [46][54] Competitive Landscape - **Competitor Analysis**: Awareness of competitors like Utrepia and their differentiation in dosing and tolerability, but confidence in Tyvaso's product profile for continued growth [31][32] - **Formulary Positioning**: Proactive engagement in contracting to position Tyvaso and Tyvaso DPI competitively against current and future products [40] Revenue Guidance - **Revenue Growth Expectation**: Anticipation of double-digit revenue growth from the current commercial business, but no specific revenue guidance provided for 2025 or 2026 [29] Additional Important Insights - **Treatment Duration**: No significant difference expected in treatment duration for IPF compared to PAH or ILD [24] - **Market Analysis**: Ongoing analysis of the IPF market to refine patient estimates and salesforce size [22] - **Regulatory Engagement**: Commitment to maintaining a strong relationship with the FDA and exploring avenues to expedite filing processes [10][13] This summary encapsulates the critical insights and strategic directions discussed during the United Therapeutics FY conference call, highlighting the company's advancements in clinical trials, regulatory approvals, commercial strategies, and future growth opportunities.

Group 1 - The article discusses United Therapeutics (NASDAQ: UTHR) and its potential to expand the Tyvaso treatment into the large Idiopathic Pulmonary Fibrosis (IPF) market [2] - The author is affiliated with Biotech Analysis Central, which provides extensive analysis and resources for healthcare investors, including a library of over 600 biotech investing articles and a model portfolio [2] - The service offers a subscription model with a monthly fee of $49 and an annual plan at a discounted rate of $399, which represents a 33.50% discount [1] Group 2 - The article does not contain any stock positions or plans to initiate positions in the companies mentioned, indicating an unbiased perspective [3] - There is a disclaimer regarding past performance not guaranteeing future results, emphasizing the independent nature of the analysis provided [4]

Core Insights - United Therapeutics (UTHR) shares increased by 33% following the announcement of positive results from the late-stage TETON-2 study for nebulized Tyvaso in idiopathic pulmonary fibrosis (IPF) patients [1][9] - The study demonstrated that Tyvaso outperformed placebo in improving lung function, as measured by forced vital capacity (FVC), with a change of 95.6 mL after 52 weeks [2][9] - The safety profile of Tyvaso remained consistent with previous studies, and benefits were observed across various patient subgroups [3] Study Details - The TETON-2 study met its primary endpoint and several key secondary endpoints, including time to first clinical worsening event and changes in lung diffusion capacity [2][3] - United Therapeutics is also conducting the TETON-1 study, with results expected in the first half of 2026, and plans to meet with the FDA to expedite regulatory review [5][6] Market Potential - Approximately 100,000 IPF patients are estimated to be in the United States, indicating a significant market opportunity for Tyvaso, which could exceed its current sales in pulmonary arterial hypertension (PAH) indications [8] - Year-to-date, UTHR shares have risen 15%, outperforming the industry growth of 12% [8] Financial Performance - In Q2 2025, United Therapeutics generated nearly $470 million from Tyvaso sales, reflecting an 18% year-over-year increase driven by patient demand [11] Industry Impact - Following UTHR's positive results, shares of other treprostinil manufacturers, Insmed (INSM) and Liquidia Corporation (LQDA), also saw increases of 7% and 3%, respectively [12] - Insmed is developing a prodrug of treprostinil, which may offer advantages in dosing frequency compared to Tyvaso [13] - Liquidia has received FDA approval for its inhaled treprostinil product, Yutrepia, marking a new competitor in the market [15]

Core Viewpoint - United Therapeutics Corporation's stock surged 33% following positive late-stage clinical trial results for Tyvaso in idiopathic pulmonary fibrosis, indicating strong market confidence in the drug's potential [2][3] Growth - Tyvaso, approved by the FDA in 2009, generated $1.6 billion in sales last year, reflecting a 31% year-over-year increase [3] - The company has seen its revenues grow at an average rate of 19.9% over the last three years, compared to a 5.3% increase for the S&P 500 [6] Profitability - United Therapeutics exhibits significantly higher profit margins than most companies in the Trefis coverage universe, with an operating margin of 50.1% over the last four quarters [8][15] - The company's net income margin stands at 40.4%, compared to 12.7% for the S&P 500 [15] Financial Stability - United Therapeutics has a very strong balance sheet, with a debt figure of $0.0 at the end of the most recent quarter, resulting in a debt-to-equity ratio of 0.0% [9][15] - Cash and cash equivalents amount to $3.0 billion, making up 38.6% of total assets of $7.9 billion [15] Downturn Resilience - UTHR stock has shown more resilience than the S&P 500 during recent downturns, recovering fully from significant declines in previous market crises [10][16] Valuation - At current levels near $400, UTHR stock trades at 6x trailing revenues, which aligns with its historical average [12] - The stock appears slightly cheap relative to the broader market based on price-to-sales and price-to-earnings ratios [7][11]

Group 1 - Proactive provides fast, accessible, informative, and actionable business and finance news content to a global investment audience [2] - The news team covers medium and small-cap markets, as well as blue-chip companies, commodities, and broader investment stories [3] - Proactive's content includes insights across various sectors such as biotech, pharma, mining, natural resources, battery metals, oil and gas, crypto, and emerging technologies [3] Group 2 - Proactive is committed to adopting technology to enhance workflows and improve content production [4] - The company utilizes automation and software tools, including generative AI, while ensuring all content is edited and authored by humans [5]

United Therapeutics Corporation UTHR released data on Tuesday from its TETON-2 study evaluating the use of nebulized Tyvaso (treprostinil) Inhalation Solution for idiopathic pulmonary fibrosis (IPF).The study met its primary efficacy endpoint of demonstrating improvement in absolute forced vital capacity (FVC) relative to placebo. FVC is a standard pulmonary function test.Tyvaso demonstrated superiority over placebo for the change in absolute FVC by 95.6 mL from baseline to week 52 in patients with IPF.Bene ...

Core Insights - MannKind Corporation has announced that United Therapeutics Corporation has exercised its option to develop a second dry powder inhalation therapy under their 2018 collaboration agreement [1][2] Group 1: Collaboration and Agreement Details - The original agreement led to the FDA approval of Tyvaso DPI in May 2022 and included an option for United Therapeutics to expand the license to additional active ingredients [2] - Under the expanded agreement, MannKind will formulate a second investigational molecule using its proprietary Technosphere platform, while United Therapeutics will handle preclinical and clinical development [2] - MannKind will receive an upfront payment of $5 million, with potential development milestone payments of up to $35 million and 10% royalties on net sales of any resulting product [3] Group 2: Development Activities - Formulation and development activities for the new investigational molecule will commence immediately [4] Group 3: Company Overview - MannKind Corporation focuses on developing and commercializing innovative inhaled therapeutic products and devices to address serious unmet medical needs, particularly in endocrine and orphan lung diseases [5] - The company aims to utilize its formulation capabilities and device engineering to alleviate the burden of diseases such as diabetes, NTM lung disease, pulmonary fibrosis, and pulmonary hypertension [6]