United Therapeutics (UTHR) reported $677.7 million in revenue for the quarter ended March 2024, representing a year-over-year increase of 33.7%. EPS of $6.17 for the same period compares to $4.86 a year ago.The reported revenue represents a surprise of +7.96% over the Zacks Consensus Estimate of $627.72 million. With the consensus EPS estimate being $5.63, the EPS surprise was +9.59%.While investors scrutinize revenue and earnings changes year-over-year and how they compare with Wall Street expectations to ...

SILVER SPRING, Md. and RESEARCH TRIANGLE PARK, N.C., May 1, 2024: United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, today announced its financial results for the quarter ended March 31, 2024. Total revenues in the first quarter of 2024 grew 34 percent year-over-year to $677.7 million, compared to $506.9 million in the first quarter of 2023. "The first quarter of 2024 represents another quarter of record revenue and double-digit year-over-year revenue growth," jointly said Martine ...

Part I: Financial Information [Item 1. Consolidated Financial Statements](index=3&type=section&id=Item%201.%20Consolidated%20Financial%20Statements) This section presents United Therapeutics Corporation's unaudited consolidated financial statements for Q1 2024 and 2023, detailing financial position, performance, and cash flows [Consolidated Balance Sheets](index=3&type=section&id=Consolidated%20Balance%20Sheets) Total assets decreased to **$6.50 billion** and equity to **$5.34 billion**, primarily due to a **$1.0 billion** share repurchase Consolidated Balance Sheet Highlights (in millions) | Account | March 31, 2024 | December 31, 2023 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $1,251.5 | $1,207.7 | | Total current assets | $3,248.7 | $3,551.0 | | Total assets | $6,495.2 | $7,167.0 | | **Liabilities & Equity** | | | | Total current liabilities | $860.6 | $804.4 | | Total liabilities | $1,157.1 | $1,182.2 | | Total stockholders' equity | $5,338.1 | $5,984.8 | | Total liabilities and stockholders' equity | $6,495.2 | $7,167.0 | [Consolidated Statements of Operations](index=4&type=section&id=Consolidated%20Statements%20of%20Operations) Total revenues increased **34%** to **$677.7 million**, with net income reaching **$306.6 million** or **$6.17** per diluted share Q1 2024 vs Q1 2023 Statement of Operations (in millions, except per share data) | Metric | Q1 2024 | Q1 2023 | | :--- | :--- | :--- | | Total revenues | $677.7 | $506.9 | | Total operating expenses | $321.4 | $222.5 | | Operating income | $356.3 | $284.4 | | Net income | $306.6 | $240.9 | | Diluted net income per share | $6.17 | $4.86 | [Consolidated Statements of Cash Flows](index=7&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) Operating cash flow was **$376.5 million**, investing activities generated **$735.3 million**, and financing used **$1.07 billion** for share repurchases Cash Flow Summary (in millions) | Activity | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :--- | :--- | :--- | | Net cash provided by operating activities | $376.5 | $374.8 | | Net cash provided by (used in) investing activities | $735.3 | $(221.1) | | Net cash (used in) provided by financing activities | $(1,068.0) | $48.6 | | Net increase in cash and cash equivalents | $43.8 | $202.3 | [Notes to Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Consolidated%20Financial%20Statements) Notes detail accounting policies, investments, debt, share-based compensation, the **$1.0 billion** share repurchase, segment revenues, litigation, and recent acquisitions - The company operates as a single operating segment focused on developing and commercializing products for chronic and life-threatening conditions[69](index=69&type=chunk) - In March 2024, the Board authorized a **$1.0 billion** share repurchase program, and the company entered into an accelerated share repurchase (ASR) agreement, receiving an initial delivery of **3,275,199 shares**[65](index=65&type=chunk) - The effective tax rate for Q1 2024 was **23%**, up from **17%** in Q1 2023, primarily due to decreased excess tax benefits from share-based compensation[67](index=67&type=chunk) Revenues by Product (in millions) | Product | Q1 2024 | Q1 2023 | | :--- | :--- | :--- | | Tyvaso DPI | $227.5 | $118.7 | | Nebulized Tyvaso | $145.0 | $119.7 | | Remodulin | $128.0 | $121.4 | | Orenitram | $106.2 | $88.2 | | Unituxin | $58.4 | $49.1 | | Adcirca | $6.4 | $7.3 | | **Total Revenues** | **$677.7** | **$506.9** | [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=25&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses Q1 2024 results, highlighting **34%** revenue growth from Tyvaso, operating expense trends, R&D pipeline progress, and the impact of a **$1.0 billion** share repurchase [Results of Operations](index=35&type=section&id=Results%20of%20Operations) Total revenues increased **34%** to **$677.7 million** driven by **56%** Tyvaso growth, with R&D up **26%** and SG&A up **65%**, and a **23%** effective tax rate Revenue by Product - Q1 2024 vs Q1 2023 (in millions) | Product | Q1 2024 | Q1 2023 | % Change | | :--- | :--- | :--- | :--- | | Total Tyvaso | $372.5 | $238.4 | 56% | | Remodulin | $128.0 | $121.4 | 5% | | Orenitram | $106.2 | $88.2 | 20% | | Unituxin | $58.4 | $49.1 | 19% | | **Total Revenues** | **$677.7** | **$506.9** | **34%** | - The increase in Tyvaso sales was primarily driven by higher quantities sold of Tyvaso DPI following its commercial launch and growth in use by PH-ILD patients[180](index=180&type=chunk) - R&D expense increased by **26%** to **$104.1 million**, mainly due to higher spending on organ manufacturing projects and the TETON clinical studies for nebulized Tyvaso[190](index=190&type=chunk)[192](index=192&type=chunk) - Share-based compensation expense increased significantly to **$25.6 million** from a benefit of **$(12.4) million** in the prior year, primarily due to STAP expense driven by a **4%** increase in stock price in Q1 2024 versus a **19%** decrease in Q1 2023[195](index=195&type=chunk) [Research and Development](index=30&type=section&id=Research%20and%20Development) R&D focuses on Phase 3 TETON studies for nebulized Tyvaso, ADVANCE OUTCOMES for ralinepag, and organ manufacturing initiatives like xenotransplantation - Enrolling two Phase 3 studies (TETON 1 and TETON 2) for nebulized Tyvaso in Idiopathic Pulmonary Fibrosis (IPF) and one Phase 3 study (TETON PPF) in Progressive Pulmonary Fibrosis (PPF)[145](index=145&type=chunk)[147](index=147&type=chunk) - Enrolling the ADVANCE OUTCOMES Phase 3 study for ralinepag, a once-daily oral prostacyclin receptor agonist for PAH[151](index=151&type=chunk) - Organ manufacturing programs are a key long-term goal, with successful xenotransplants of porcine hearts (UHeart) and a thymokidney (UThymoKidney) into living human patients under compassionate use authorizations[154](index=154&type=chunk)[161](index=161&type=chunk)[166](index=166&type=chunk) - In February 2024, the company inaugurated a clinical-scale, designated pathogen-free (DPF) facility in Virginia to supply cGMP-compliant xenografts for human clinical trials[160](index=160&type=chunk) [Financial Condition, Liquidity, and Capital Resources](index=39&type=section&id=Financial%20Condition%2C%20Liquidity%2C%20and%20Capital%20Resources) The company maintains **$4.2 billion** liquidity, initiated a **$1.0 billion** ASR, and reduced its credit facility balance to **$600.0 million** Liquidity Position (in millions) | Category | March 31, 2024 | December 31, 2023 | | :--- | :--- | :--- | | Cash and cash equivalents | $1,251.5 | $1,207.7 | | Marketable investments | $2,948.2 | $3,696.2 | | **Total** | **$4,199.7** | **$4,903.9** | - In March 2024, the company paid **$1.0 billion** to repurchase common stock under an ASR agreement[198](index=198&type=chunk)[204](index=204&type=chunk) - The outstanding balance under the Credit Agreement was reduced to **$600.0 million** as of March 31, 2024, from **$700.0 million** at year-end 2023[199](index=199&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=39&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company reports no material changes in its market risk exposure since December 31, 2023 - There have been no material changes in the company's market risk exposure since the end of the previous fiscal year[208](index=208&type=chunk) [Item 4. Controls and Procedures](index=39&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls were effective as of March 31, 2024, with no material changes in internal control over financial reporting - The CEO and CFO have concluded that disclosure controls and procedures were effective as of the end of the period[209](index=209&type=chunk) - No changes in internal control over financial reporting occurred during the quarter that have materially affected, or are reasonably likely to materially affect, such controls[209](index=209&type=chunk) Part II: Other Information [Item 1. Legal Proceedings](index=40&type=section&id=Item%201.%20Legal%20Proceedings) This section incorporates by reference the detailed discussion of legal proceedings from Note 12 of the consolidated financial statements - For details on legal proceedings, the report refers to Note 12—Litigation in the financial statements[210](index=210&type=chunk) [Item 1A. Risk Factors](index=40&type=section&id=Item%201A.%20Risk%20Factors) This section outlines significant business risks, including reliance on treprostinil therapies, competition, IRA pricing pressures, supply chain, IP challenges, and PBC risks - The company relies heavily on sales of its treprostinil-based therapies (Tyvaso DPI, nebulized Tyvaso, Remodulin, Orenitram), which comprise the vast majority of revenues[211](index=211&type=chunk) - Competition is a major risk, with over fifteen competing PAH drugs and new entrants like Merck's Winrevair™ and potentially Liquidia's Yutrepia, which could materially adversely affect revenues[215](index=215&type=chunk) - The Inflation Reduction Act (IRA) is expected to have a significant impact, particularly the new Medicare Part D discounting program beginning in 2025, which will affect Orenitram and Tyvaso DPI revenues[247](index=247&type=chunk)[250](index=250&type=chunk) - Manufacturing strategy exposes the company to risks, including reliance on third parties like MannKind for Tyvaso DPI and the complexity of developing manufacturing for organ programs[220](index=220&type=chunk)[223](index=223&type=chunk)[230](index=230&type=chunk) - Intellectual property rights may not deter competitors, with ongoing patent challenges from Liquidia regarding Tyvaso patents being a notable risk[273](index=273&type=chunk)[276](index=276&type=chunk) - As a Public Benefit Corporation (PBC), directors must balance shareholder financial interests with the company's public benefit purpose, which could influence decisions in ways that do not maximize short-term shareholder value and may increase litigation risk[296](index=296&type=chunk)[298](index=298&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=53&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) In March 2024, the Board approved a **$1.0 billion** share repurchase program, initiating an ASR and receiving **3,275,199 shares** - On March 25, 2024, the company initiated a **$1.0 billion** share repurchase program and entered into an ASR agreement with Citibank[299](index=299&type=chunk) - An initial delivery of **3,275,199 shares** was received on March 27, 2024, representing approximately **80%** of the total shares expected to be repurchased under the ASR agreement[299](index=299&type=chunk) [Item 5. Other Information](index=54&type=section&id=Item%205.%20Other%20Information) No director or Section 16 officer adopted or terminated any Rule 10b5-1 trading plans or other non-Rule 10b5-1 trading arrangements during Q1 2024 - No director or Section 16 officer adopted or terminated any Rule 10b5-1 plans or non-Rule 10b5-1 trading arrangements during the quarter[300](index=300&type=chunk) [Item 6. Exhibits](index=54&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Form 10-Q, including corporate documents, the accelerated share repurchase agreement, and officer certifications - Key exhibits filed include the Master Confirmation for the Accelerated Share Repurchase with Citibank, N.A., dated March 25, 2024[301](index=301&type=chunk)

United Therapeutics (UTHR) could be a solid choice for investors given its recent upgrade to a Zacks Rank #2 (Buy). This upgrade primarily reflects an upward trend in earnings estimates, which is one of the most powerful forces impacting stock prices.The sole determinant of the Zacks rating is a company's changing earnings picture. The Zacks Consensus Estimate -- the consensus of EPS estimates from the sell-side analysts covering the stock -- for the current and following years is tracked by the system.The ...

SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, announced today that Patrick Poisson, Executive Vice President, Technical Operations, will provide an overview and update on the company’s operations during a fireside chat session at the Leerink Partners Global Biopharma Conference 2024 in Miami Beach, Florida. The session will take place on Tuesday, March 12, 2024, from 1:40 p.m. to 2:10 p.m., Eastern Daylight ...

SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, announced today that Michael Benkowitz, President and Chief Operating Officer, will provide an overview and update on the company’s operations during a fireside chat session at the TD Cowen 44th Annual Health Care Conference in Boston. The session will take place on Tuesday, March 5, 2024, from 12:50 p.m. to 1:20 p.m., Eastern Standard Time, and can be accessed v ...

United Therapeutics‘ (UTHR) fourth-quarter 2023 earnings of $4.36 per share beat the Zacks Consensus Estimate of $3.92. Earnings rose 63% year over year on the back of higher product sales.Revenues in the reported quarter were $614.7 million, beating the Zacks Consensus Estimate of $562 million. Revenues rose 25% year over year, driven by Tyvaso sales.Quarter in DetailUnited Therapeutics markets four products for pulmonary arterial hypertension (PAH) — Remodulin, Tyvaso, Adcirca and Orenitram. It also marke ...

United Therapeutics (UTHR) closed the last trading session at $219.18, gaining 0.2% over the past four weeks, but there could be plenty of upside left in the stock if short-term price targets set by Wall Street analysts are any guide. The mean price target of $290.92 indicates a 32.7% upside potential.The mean estimate comprises 13 short-term price targets with a standard deviation of $50.38. While the lowest estimate of $178 indicates a 18.8% decline from the current price level, the most optimistic analys ...

Financial Data and Key Metrics Changes - The company reported its highest revenue quarter ever at $615 million, up 25% from Q4 2022, and record annual revenues of over $2.3 billion, up 20% over 2022 [16][24] - Worldwide Remodulin revenue was $115 million for Q4, down 6% year-over-year, primarily due to international order timing, while U.S. Remodulin revenue was up 9% [17] - Worldwide Unituxin revenue was $54 million in Q4, up 48% from the prior year, driven by pricing and volume increases [36] Business Line Data and Key Metrics Changes - Tyvaso revenue increased 45% to $351 million, with U.S. revenue up 40% to $337 million, marking the highest quarter ever for both [62] - Orenitram revenue was $84 million during the quarter, up 11% from the prior year, reflecting increases in volume, price, and average dose [60] - The company noted that both Tyvaso nebulizer and Tyvaso DPI remain the most prescribed prostacyclin treatments in the U.S. and the only approved therapies for PH-ILD [62] Market Data and Key Metrics Changes - The company believes that the IPF market represents a 100,000 patient opportunity in the U.S., with only two approved therapies currently available [9] - The company anticipates that the mix of Tyvaso patients being treated for PH-ILD will continue to grow, with a current estimate of around 50-50 between PAH and PH-ILD [100] Company Strategy and Development Direction - The company is positioned for three waves of growth: existing commercial business, near-term pipeline led by TETON studies, and long-term growth through organ technologies [25][8] - The company is developing several investigational approaches using multiple technologies for organ transplantation, including xenotransplantation and bioartificial organs [13][57] - The company is focused on expanding its sales force to increase market share in PH-ILD and enhance prescriber engagement [55] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in meeting revenue growth targets despite potential challenges from clinical trial outcomes and regulatory approvals [8] - The company is optimistic about the prospects for its Tyvaso DPI product, citing strong demand metrics and record referrals [47][48] - Management highlighted the importance of safety in clinical trials and the company's commitment to ensuring patient safety as a priority [92] Other Important Information - The company received FDA clearance for its investigational new drug application for the miroliverELAP system, allowing it to enter human clinical trials [59] - The company is actively pursuing business development opportunities, focusing on complementary products and platforms in rare lung and cardiovascular diseases [93] Q&A Session Summary Question: Can you discuss the underlying patient demand for Tyvaso and inventory dynamics? - Management noted record referrals for Tyvaso, with a slight decrease in conversion to starts, which is expected to improve in Q1 [46][48] Question: How will the IRA changes affect out-of-pocket costs for patients? - Management indicated that the elimination of the catastrophic phase will lower out-of-pocket costs for patients, leading to a reduction in the utilization of the patient assistance program [51][80] Question: What is the expected mix of Tyvaso patients for PAH versus PH-ILD? - Management expects the mix to trend in favor of PH-ILD as the company continues to expand its market presence [83][100] Question: How does the company view safety in the adoption of new therapies? - Management emphasized that safety is a top priority and that physicians will consider the safety profile of new therapies when making treatment decisions [117][92] Question: What are the company's capital allocation priorities? - The company focuses on internal research and development, business development opportunities, and returning capital to shareholders [116][93]

Financial Performance - Total revenue reached $615 million, a 25% year-over-year increase[34] - Tyvaso revenue was $351 million, representing a 45% year-over-year increase[34] - Remodulin revenue was $115 million, a 6% year-over-year increase[34] - Orenitram revenue was $84 million, an 11% year-over-year increase[34] - Unituxin revenue was $54 million, a 48% year-over-year increase[34] - The company's operating cash flow for FY23 was $978 million[24] - The company has $4.9 billion in cash, cash equivalents, and marketable investments[24] Tyvaso DPI - Sagard Healthcare Partners acquired a 1% royalty interest in Tyvaso DPI from MannKind for $150 million plus other milestones[13] - The company highlights an implied Tyvaso DPI revenue valuation of over $15 billion based on a deal executed after an appeals court ruling, where a 1% royalty equated to $150 million[114] Clinical Trials and Development - TETON 1 and TETON 2 studies for Idiopathic Pulmonary Fibrosis (IPF) are approximately 70% enrolled[28] - The ADVANCE OUTCOMES study for PAH is targeted for trial completion in 2025[31]