United Therapeutics(US:UTHR)2025-07-30 10:34Part I Financial Information Consolidated Financial Statements The consolidated financial statements present the company's financial position, results of operations, and cash flows for the periods ended June 30, 2025 Consolidated Balance Sheets As of June 30, 2025, total assets increased to $7.91 billion from $7.36 billion at year-end 2024, driven by growth in marketable investments and property, plant, and equipment Consolidated Balance Sheet Highlights (in millions) | Account | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Total Assets | $7,908.0 | $7,364.0 | | Cash and cash equivalents | $1,593.1 | $1,697.2 | | Total marketable investments | $3,373.3 | $3,045.1 | | Property, plant, and equipment, net | $1,362.4 | $1,222.4 | | Total Liabilities | $734.4 | $920.0 | | Line of credit | $— | $300.0 | | Total Stockholders' Equity | $7,173.6 | $6,444.0 | Consolidated Statements of Operations For the six months ended June 30, 2025, revenues grew 14.4% to $1.59 billion, with net income reaching $631.7 million and diluted EPS of $13.02 Statement of Operations Summary (in millions, except per share data) | Metric | Q2 2025 | Q2 2024 | YoY Change | H1 2025 | H1 2024 | YoY Change | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Total revenues | $798.6 | $714.9 | +11.7% | $1,593.0 | $1,392.6 | +14.4% | | Operating income | $364.5 | $319.9 | +13.9% | $747.3 | $676.2 | +10.5% | | Net income | $309.5 | $278.1 | +11.3% | $631.7 | $584.7 | +8.0% | | Diluted EPS | $6.41 | $5.85 | +9.6% | $13.02 | $12.03 | +8.2% | Consolidated Statements of Cash Flows Net cash provided by operating activities increased 7% to $652.9 million for the six months ended June 30, 2025, while investing activities shifted to a net use of $464.6 million Six Months Ended June 30, Cash Flow Summary (in millions) | Cash Flow Category | 2025 | 2024 | | :--- | :--- | :--- | | Net cash provided by operating activities | $652.9 | $608.7 | | Net cash (used in) provided by investing activities | $(464.6) | $655.3 | | Net cash used in financing activities | $(292.4) | $(1,116.0) | | Net (decrease) increase in cash | $(104.1) | $148.0 | Notes to Consolidated Financial Statements The notes provide detailed information on revenues, share-based compensation, a new $2.5 billion credit facility, and ongoing litigation - In April 2025, the company entered into a new $2.5 billion unsecured revolving credit facility, maturing in 2030, with a zero outstanding balance as of June 30, 2025373943 - Total share-based compensation expense for the six months ended June 30, 2025 was $69.6 million, a decrease from $75.3 million in 2024 due to the exercise of remaining STAP awards475758 - The effective tax rate for the first six months of 2025 was 24%, up from 22% in 2024, primarily due to decreased excess tax benefits from share-based compensation66 Revenues by Product - Six Months Ended June 30 (in millions) | Product | 2025 | 2024 | % Change | | :--- | :--- | :--- | :--- | | Tyvaso DPI | $617.7 | $485.8 | +27.2% | | Nebulized Tyvaso | $318.2 | $284.9 | +11.7% | | Remodulin | $272.9 | $275.3 | -0.9% | | Orenitram | $244.6 | $213.3 | +14.7% | | Unituxin | $116.6 | $110.1 | +5.9% | | Total Revenues | $1,593.0 | $1,392.6 | +14.4% | - The company is involved in multiple legal proceedings, including patent and trade secret litigation with Liquidia, and accrued a $72.6 million liability from Sandoz litigation as of June 30, 2025818284 Management's Discussion and Analysis (MD&A) Management discusses financial performance driven by Tyvaso DPI and Orenitram sales, competitive pressures, R&D pipeline progress, and capital expenditure plans Results of Operations For the six months ended June 30, 2025, revenues increased 14% to $1.59 billion, with R&D and SG&A expenses rising due to milestone payments, organ manufacturing, and a PP&E impairment charge Six Months Ended June 30, 2025 vs 2024 (in millions) | Line Item | 2025 | 2024 | $ Change | % Change | | :--- | :--- | :--- | :--- | :--- | | Total Revenues | $1,593.0 | $1,392.6 | $200.4 | 14% | | Cost of Sales | $180.1 | $150.7 | $29.4 | 20% | | Research & Development | $283.0 | $243.7 | $39.3 | 16% | | Selling, General, & Administrative | $382.6 | $322.0 | $60.6 | 19% | | Operating Income | $747.3 | $676.2 | $71.1 | 11% | - Tyvaso DPI net product sales increased by $131.9 million (27%) for the first six months of 2025, driven by patient growth and increased utilization following Medicare Part D redesign167169 - R&D expense growth was driven by a $35.0 million increase in milestone payments for drug delivery technologies and increased spending on manufactured organ projects182 - SG&A expenses included a $21.7 million impairment charge for certain property, plant, and equipment during the second quarter of 2025183185 Research and Development R&D focuses on expanding existing product indications and advancing manufactured organs, with key milestones including TETON 2 data expected in September 2025 and FDA IND clearance for UKidney - Enrollment is complete for the TETON 1 and TETON 2 Phase 3 studies of Nebulized Tyvaso for Idiopathic Pulmonary Fibrosis (IPF), with topline data from TETON 2 expected in September 2025130134 - The FDA cleared an Investigational New Drug (IND) application for the UKidney xenotransplant product in January 2025, allowing a clinical trial to commence142143146 - Recent acquisitions of Miromatrix and IVIVA have expanded capabilities in regenerative medicine, with a Phase 1 study of miroliverELAP® initiated in June 2025159 Financial Condition, Liquidity, and Capital Resources The company maintains a strong liquidity position with $4.97 billion in cash and marketable investments, secured a new $2.5 billion credit facility, and authorized a $1.0 billion share repurchase program - Total cash, cash equivalents, and marketable investments stood at $4.97 billion as of June 30, 2025193 - In April 2025, the company entered into a new five-year, $2.5 billion unsecured revolving credit facility, with a zero balance as of June 30, 2025192199 - In July 2025, the board authorized a new share repurchase program for up to $1.0 billion of common stock, expiring March 31, 2026191 Quantitative and Qualitative Disclosures About Market Risk The company states that its exposure to market risk has not materially changed since December 31, 2024 - There have been no material changes in the company's exposure to market risk since the end of the previous fiscal year202 Controls and Procedures As of June 30, 2025, disclosure controls and procedures were effective, with no material changes in internal control over financial reporting during the quarter - Management concluded that as of June 30, 2025, the company's disclosure controls and procedures are effective203 - No changes in internal control over financial reporting occurred during the quarter that have materially affected, or are reasonably likely to materially affect, such controls203 Part II Other Information Legal Proceedings This section incorporates by reference the detailed discussion of litigation from Note 12 of the financial statements, including disputes with Sandoz and Liquidia - The company refers to Note 12 of the consolidated financial statements for details on legal proceedings205 Risk Factors The company outlines significant risks including reliance on treprostinil therapies, intense competition, IRA impact, manufacturing challenges, and unique litigation risks as a Public Benefit Corporation - The company relies heavily on sales of its treprostinil-based therapies, which comprise the vast majority of its revenues206 - Competition is a major risk, with over fifteen competing PAH drugs and new entrants like Merck's Winrevair and Liquidia's Yutrepia, approved in May 2025210 - The Inflation Reduction Act (IRA) is expected to significantly impact revenues, particularly the Medicare Part D manufacturer discounting program affecting Tyvaso DPI and Orenitram starting in 2025244246 - Significant manufacturing risks exist, including reliance on third-party manufacturers like MannKind for Tyvaso DPI and complex processes for manufactured organ programs214215225 - The company's status as a Public Benefit Corporation (PBC) requires balancing shareholder interests with its public benefit purpose, exposing it to unique litigation risks293294296 Unregistered Sales of Equity Securities and Use of Proceeds The company reported no unregistered sales of equity securities or repurchases of its outstanding equity securities during the six months ended June 30, 2025 - During the six months ended June 30, 2025, the company did not repurchase any of its equity securities or sell any unregistered equity securities297 Other Information In Q2 2025, Chairperson and CEO Dr. Martine Rothblatt and officer Michael Benkowitz adopted Rule 10b5-1(c) trading plans to exercise stock options and sell shares - On May 2, 2025, Chairperson and CEO Dr. Martine Rothblatt adopted a Rule 10b5-1(c) trading plan to exercise up to 294,000 stock options298 - On June 3, 2025, trusts beneficially owned by officer Michael Benkowitz adopted a Rule 10b5-1(c) trading plan to exercise up to 576,940 stock options299 Exhibits This section lists the exhibits filed with the Form 10-Q, including the new Credit Agreement from April 2025 and amended Stock Incentive Plan - Key exhibits filed include the Credit Agreement dated April 25, 2025, and the Amended and Restated 2015 Stock Incentive Plan301