Financial Performance - United Therapeutics reported quarterly earnings of $6.63 per share, exceeding the Zacks Consensus Estimate of $6.29 per share, and up from $6.17 per share a year ago, representing an earnings surprise of 5.41% [1] - The company posted revenues of $794.4 million for the quarter ended March 2025, surpassing the Zacks Consensus Estimate by 9.39%, compared to year-ago revenues of $677.7 million [2] Earnings Outlook - The current consensus EPS estimate for the upcoming quarter is $6.75 on revenues of $771.36 million, and for the current fiscal year, it is $27.03 on revenues of $3.13 billion [7] - The estimate revisions trend for United Therapeutics is mixed, resulting in a Zacks Rank 3 (Hold) for the stock, indicating expected performance in line with the market in the near future [6] Industry Context - The Medical - Drugs industry, to which United Therapeutics belongs, is currently in the top 20% of over 250 Zacks industries, suggesting a favorable outlook compared to the bottom 50% [8] - Empirical research indicates a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can be tracked by investors [5]

Financial Performance - Total revenue reached $794 million, a 17% increase compared to Q1 2024[22] - Tyvaso (DPI and nebulized) generated $466 million in revenue, representing a 25% year-over-year growth[22] - Remodulin revenue increased by 8% year-over-year to $138 million[22] - Orenitram revenue grew by 14% year-over-year to $121 million[22] - Unituxin revenue remained stable at $58 million compared to the previous year[22] Pipeline and Development - TETON 1 and 2 studies for Tyvaso in Idiopathic Pulmonary Fibrosis (IPF) have completed enrollment, with TETON 2 data expected in the second half of 2025 and TETON 1 data expected in the first half of 2026[31,33] - The ADVANCE OUTCOMES study for Ralinepag in Pulmonary Arterial Hypertension (PAH) is nearing full enrollment, with data expected in 2026[41] - The EXPAND study for UKidney is progressing, with the first transplant expected in mid-2025[49] Strategic Outlook - The company is positioned for multiple waves of growth, with a focus on its current commercial portfolio, innovation in Tyvaso IPF/PPF and Ralinepag PAH, and revolution through xenotransplantation and organ alternatives[25]

Financial Performance - Total revenues for Q1 2025 increased by 17% year-over-year to $794.4 million, compared to $677.7 million in Q1 2024[1] - Net income for Q1 2025 was $322.2 million, reflecting a 5% increase from $306.6 million in Q1 2024[3] - Total revenues for Q1 2025 were $794.4 million, a 17.3% increase from $677.7 million in Q1 2024[28] - Operating income for Q1 2025 was $382.8 million, compared to $356.3 million in Q1 2024, reflecting a growth of 7.3%[28] - Net income for Q1 2025 was $322.2 million, up from $306.6 million in Q1 2024, representing a 5.1% increase[28] - Basic net income per share increased to $7.18 in Q1 2025 from $6.52 in Q1 2024, a rise of 10.1%[28] Revenue Breakdown - Total Tyvaso revenues grew by 25% to $466.3 million in Q1 2025, up from $372.5 million in Q1 2024[5] - Tyvaso DPI sales increased by 33% to $302.5 million, while nebulized Tyvaso sales rose by 13% to $163.8 million[4] - The growth in Tyvaso DPI revenues was driven by an increase in quantities sold, particularly among patients with pulmonary hypertension associated with interstitial lung disease[6] Expenses - Research and development expenses surged by 43% to $149.0 million in Q1 2025, compared to $104.1 million in Q1 2024[13] - Selling, general, and administrative expenses increased by 18% to $170.1 million in Q1 2025, up from $144.4 million in Q1 2024[16] - The company reported a significant increase in personnel expenses due to growth in headcount, contributing to the rise in general and administrative expenses[17] Tax and Financial Position - The effective income tax rate for Q1 2025 was 24%, up from 23% in Q1 2024, primarily due to decreased excess tax benefits from share-based compensation[20] - Cash, cash equivalents, and marketable investments totaled $5,032.0 million as of March 31, 2025[30] - Total assets were reported at $7,743.9 million, while total liabilities stood at $936.7 million as of March 31, 2025[30] Future Plans and Innovations - The company plans to advance its UHeart and UThymoKidney products with anticipated FDA investigational new drug applications[2] - The company plans to expand its reach in the pulmonary hypertension market and solidify its position with prostacyclin products[24] - Upcoming clinical studies include the TETON 2 trial for idiopathic pulmonary fibrosis and the UKidney first in human study[24] - The company aims to innovate for unmet medical needs and develop technologies for transplantable organ alternatives[24]

Revenue Growth and Sales Performance - Total revenues primarily consist of sales from commercial products, with price increases typically in the single-digit percentages per year[107]. - The company anticipates revenue growth driven by increased sales of Tyvaso DPI and Orenitram, along with modest price increases for some products[157]. - Total revenues for the three months ended March 31, 2025, increased by 17% to $794.4 million compared to $677.7 million for the same period in 2024[163]. - Tyvaso total net product sales grew by 25% to $466.3 million for the three months ended March 31, 2025, compared to $372.5 million for the same period in 2024[165]. - Tyvaso DPI net product sales increased by $75.0 million (33%) to $302.5 million for the three months ended March 31, 2025, compared to $227.5 million for the same period in 2024[163]. - Nebulized Tyvaso net product sales increased by $18.8 million (13%) to $163.8 million for the three months ended March 31, 2025, compared to $145.0 million for the same period in 2024[163]. - Orenitram net product sales increased by $14.5 million (14%) to $120.7 million for the three months ended March 31, 2025, compared to $106.2 million for the same period in 2024[163]. Research and Development - Research and development expenses include costs for clinical trials and third-party arrangements, with no tracking of fully-burdened expenses by individual product[121]. - The company has completed enrollment in the TETON 1 and TETON 2 studies with 598 and 597 patients respectively, targeting idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF)[127]. - The TETON studies showed significant improvements in forced vital capacity (FVC) with a 2.5% increase at week 8 and a 3.5% increase at week 16 for IPF patients[128]. - The company plans to seek FDA approval to expand the nebulized Tyvaso label to include indications for IPF and PPF if the TETON studies are successful[130]. - Ralinepag demonstrated a 29.8% reduction in median pulmonary vascular resistance (PVR) in a phase 2 study, with a p-value of 0.03[132]. - The ADVANCE OUTCOMES study is targeting enrollment of approximately 700 patients and aims to evaluate the time to first clinical worsening event in PAH patients[133]. - The company aims to develop an oral triple-combination therapy consisting of ralinepag, an endothelin receptor antagonist, and a PDE-5 inhibitor if the ADVANCE OUTCOMES study is successful[136]. Legal and Regulatory Matters - Ongoing litigation includes a lawsuit against Sandoz and Liquidia regarding patent and trade secret issues related to Remodulin and Tyvaso DPI[109]. - The company has settled litigation allowing generic versions of nebulized Tyvaso and Orenitram to enter the market in 2026 and 2027, respectively[113]. - The company is engaged in litigation concerning the regulatory exclusivity of its products, with a court ruling in its favor regarding exclusivity until May 2025[115]. Financial Performance and Expenses - Research and development expenses increased by 43% to $149.0 million in Q1 2025, compared to $104.1 million in Q1 2024[175]. - Selling, general, and administrative expenses rose by 18% to $170.1 million in Q1 2025, up from $144.4 million in Q1 2024[179]. - Gross-to-net deductions totaled $177.8 million as of March 31, 2025, compared to $131.1 million in the same period of 2024[171]. - The effective income tax rate for Q1 2025 was 24%, an increase from 23% in Q1 2024, primarily due to decreased excess tax benefits from share-based compensation[184]. - Share-based compensation expense increased by 24% to $31.8 million in Q1 2025, compared to $25.6 million in Q1 2024[182]. - Cost of sales for Q1 2025 was $92.5 million, a 27% increase from $72.9 million in Q1 2024[173]. Cash Flow and Investments - Net cash provided by operating activities for the three months ended March 31, 2025, was $461.2 million, an increase of $84.7 million (22%) compared to $376.5 million in the same period of 2024[190]. - Net cash used in investing activities increased by $900.0 million (122%) to $(164.7) million for the three months ended March 31, 2025, primarily due to increased purchases of marketable investments[192]. - The net cash used in financing activities decreased by $974.2 million (91%) to $(93.8) million for the three months ended March 31, 2025, compared to $(1,068.0) million in the same period of 2024[193]. - As of March 31, 2025, cash and cash equivalents increased by $202.7 million (12%) to $1,899.9 million compared to December 31, 2024[189]. - Total cash and cash equivalents and marketable investments reached $5,032.0 million, reflecting a $289.7 million (6%) increase from $4,742.3 million as of December 31, 2024[189]. - Marketable investments—current decreased by $148.4 million (9%) to $1,421.4 million as of March 31, 2025, compared to $1,569.8 million as of December 31, 2024[189]. - Marketable investments—non-current increased by $235.4 million (16%) to $1,710.7 million as of March 31, 2025, compared to $1,475.3 million as of December 31, 2024[189]. - The company reported a significant increase in cash used for total purchases, sales, and maturities of marketable investments, contributing to the rise in cash used in investing activities[192]. Strategic Initiatives and Acquisitions - The company has entered into distribution agreements with Accredo and Caremark for Tyvaso DPI and other products in the U.S.[107]. - The company expects to manufacture sufficient quantities of commercial products, including plans to expand manufacturing capacity for Tyvaso DPI[106]. - The company has budgeted approximately $750 million for capital expenditures from Q2 2025 through the end of 2027 to support product development and commercialization[159]. - The company completed the first successful xenotransplantation of porcine hearts into two human patients, marking a significant milestone in organ transplantation[148]. - The company acquired Miromatrix Medical Inc. in December 2023, focusing on developing manufactured kidney and liver alternatives[155]. - The company is developing scalable technologies for efficient organ delivery, including partnerships for electric aircraft systems to minimize environmental impact[153].

Financial Data and Key Metrics Changes - United Therapeutics reported record revenue for 2024, marking the third consecutive year of record-setting revenue, with a nearly 24% growth over the full year 2023 and a 20% revenue growth in Q4 compared to Q4 2023 [9][21] - Total Tyvaso revenue for Q4 was $4 million, a 19% increase year-over-year, despite a slight sequential decline in net revenue due to contracting efforts [22][21] - Orenitram revenue grew by 28% in Q4 to $108 million, while Remodulin revenue reached $135 million, up 17% from the prior year [24][25] Business Line Data and Key Metrics Changes - Tyvaso experienced record patient shipments and near-record referrals, although the sequential decline in revenue was attributed to a larger gross-to-net ratio due to recent contracting efforts [22][23] - Orenitram saw record patient shipments, with close to 50% of new starts coming from transitions from Remodulin [24] - Unituxin achieved record revenue of $68 million in Q4, up 25% from the prior year, driven by both price and volume increases [27] Market Data and Key Metrics Changes - The company noted strong referral and start trends for Remodulin, with the new RemUnity Pro pump receiving FDA clearance, expected to launch later this year [26] - The expansion of the sales force in 2024 aimed to drive prescribing growth in the ILD treating community, resulting in significant prescriber growth [66][70] Company Strategy and Development Direction - The company is focused on a disciplined financial algorithm and capital allocation philosophy, having returned $1 billion to shareholders through an accelerated share repurchase program [18][19] - The development pipeline includes the uKidney clinical trial, which could potentially end dialysis for patients with end-stage renal disease, and the inhaled treprostinil for idiopathic pulmonary fibrosis [10][11] - The company is also excited about Ralinepag, which could change the treatment paradigm for pulmonary arterial hypertension [14][15] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in continuing double-digit growth for the foundational business and anticipated growth inflection with expected approvals for Ralinepag and IPF indications for Tyvaso [35][36] - The management team emphasized the importance of executing commercially and maintaining strong dynamics in the business [28][29] Other Important Information - The company has made significant investments in capital expenditures to support new manufacturing facilities and has acquired companies to enhance organ alternative development expertise [17] - The company is committed to evaluating its capital allocation strategy continuously [19] Q&A Session Summary Question: Growth trajectory for 2025 and seasonality impacts - Management expects continued double-digit growth for the foundational business and does not foresee changes in growth projections despite recent contracting efforts [35][36] Question: uKidney clinical trial and investment in DPF facilities - The first transplant is expected mid-year, with a formal review of safety and patient survival data planned before proceeding with additional transplants [44][45] Question: Tyvaso's growth in the context of competitive dynamics - Management believes that Tyvaso can continue to grow despite competition, as it remains a critical part of the treatment for pulmonary arterial hypertension [50][51] Question: Baseline disease severity of the first patient in the xenotransplant study - The first patients will not have severe comorbidities but are not eligible for current kidney transplant waitlists due to medical reasons [58][59] Question: Tyvaso's intellectual property and contracting strategy - The company has implemented a strategy to lock in payers with additional rebates to maintain competitive parity and ensure continued growth [80]

United Therapeutics Corporation Fourth Quarter 2024 Corporate Update February 26, 2025 INTRODUCTION Safe Harbor Statement All statements in this presentation are made as of February 26, 2025. We undertake no obligation to publicly update or revise these statements, whether as a result of new information, future events, or otherwise. Statements included in this presentation that are not historical in nature are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of ...

Core Viewpoint - United Therapeutics reported strong fourth-quarter 2024 earnings and revenue growth, driven by increased product sales, although Tyvaso sales fell short of expectations [1][2][4]. Financial Performance - Fourth-quarter 2024 earnings were $6.19 per share, exceeding the Zacks Consensus Estimate of $6.10, representing a 42% year-over-year increase [1]. - Revenues for the quarter reached $735.9 million, surpassing the Zacks Consensus Estimate of $725.3 million, and reflecting a 20% year-over-year growth [2]. - Full-year 2024 earnings were $24.64 per share, beating the Zacks Consensus Estimate of $24.48, with a 124.3% year-over-year increase [9]. - Total revenues for 2024 were $2.89 billion, exceeding the Zacks Consensus Estimate of $2.87 billion, and showing a 24% year-over-year growth [9]. Product Sales Breakdown - Tyvaso sales totaled $415.9 million, a 19% increase year-over-year, although it missed the Zacks Consensus Estimate of $425 million [4]. - Tyvaso dry powder inhalation (DPI) sales were $273.2 million, up 28% year-over-year, while nebulized Tyvaso sales were $142.7 million, up 4% [3]. - Remodulin sales rose 17% year-over-year to $134.5 million, and Orenitram sales increased 28% year-over-year to $107.8 million [5]. - Unituxin sales grew 25% year-over-year to $67.5 million, while Adcirca sales decreased by 31% to $4.7 million [5]. Research and Development - Research and development expenses were $133.8 million, down 12% year-over-year due to prior year costs [8]. - Selling, general, and administrative expenses increased by 27% to $168.5 million, attributed to higher personnel and legal costs [8]. Pipeline and Future Prospects - Key phase III programs include Tyvaso for chronic fibrosing interstitial lung disease and oral ralinepag for PAH [10]. - Top-line data from the TETON-2 study is expected in the second half of 2025, with potential for Tyvaso sales to exceed current levels if approved for idiopathic pulmonary fibrosis [11]. - The FDA has cleared a new drug application for a clinical study on xenotransplantation with investigational UKidney [12].

Group 1 - United Therapeutics reported quarterly earnings of $6.19 per share, exceeding the Zacks Consensus Estimate of $6.10 per share, and up from $4.36 per share a year ago, representing an earnings surprise of 1.48% [1] - The company achieved revenues of $735.9 million for the quarter ended December 2024, surpassing the Zacks Consensus Estimate by 1.46%, and an increase from $614.7 million year-over-year [2] - Over the last four quarters, United Therapeutics has surpassed consensus EPS estimates three times and topped consensus revenue estimates four times [2] Group 2 - The stock's immediate price movement will depend on management's commentary during the earnings call and future earnings expectations [3] - United Therapeutics shares have gained approximately 1.3% since the beginning of the year, matching the S&P 500's gain of 1.3% [3] - The current consensus EPS estimate for the upcoming quarter is $6.88 on revenues of $741.63 million, and for the current fiscal year, it is $27.49 on revenues of $3.14 billion [7] Group 3 - The estimate revisions trend for United Therapeutics is currently unfavorable, resulting in a Zacks Rank 4 (Sell) for the stock, indicating expected underperformance in the near future [6] - The Medical - Drugs industry, to which United Therapeutics belongs, is currently in the top 50% of Zacks industries, suggesting that stocks in this category tend to outperform those in the bottom 50% [8]

Financial Performance - United Therapeutics reported full year 2024 revenues of $2.88 billion, a 24% increase from 2023[1] - Fourth quarter 2024 total revenues reached $735.9 million, up 20% from $614.7 million in Q4 2023[3] - Net income for the full year 2024 was $1.195 billion, compared to $984.8 million in 2023, reflecting a 21% increase[3] - Total net income per diluted share for 2024 was $24.64, up from $19.81 in 2023[3] - Operating income for the year ended December 31, 2024, was $1,377.0 million, up 16.3% from $1,184.9 million in 2023[31] - Net income for Q4 2024 was $301.3 million, representing a 38.7% increase compared to $217.1 million in Q4 2023[31] - Basic net income per share for the year ended December 31, 2024, was $26.44, an increase of 25.4% from $21.04 in 2023[31] Sales and Product Performance - Tyvaso product sales grew by 31% to $1.620 billion in 2024, driven by increased patient numbers and utilization[7] - The company experienced a 41% increase in Tyvaso DPI sales for the full year, totaling $1.034 billion[4] - Total revenues for Q4 2024 reached $735.9 million, a 19.7% increase from $614.7 million in Q4 2023[31] Research and Development - Research and development expenses for 2024 totaled $481 million, an 18% increase from $408 million in 2023[12] - Research and development expenses for Q4 2024 were $133.8 million, a decrease from $151.4 million in Q4 2023[31] - Research and development expenses increased to $40.2 million for drug delivery device technologies and $8.0 million for ex vivo lung perfusion technology in 2024, compared to 2023[14] Expenses and Liabilities - The cost of sales for the year increased by 19% to $304.3 million, primarily due to growth in Tyvaso DPI revenues[10] - Selling, general, and administrative expenses rose by 27% to $168.5 million for the three months ended December 31, 2024, and by 49% to $709.7 million for the year ended December 31, 2024, compared to 2023[15] - Share-based compensation expense increased by 63% to $27.0 million for the three months ended December 31, 2024, and by 268% to $144.0 million for the year ended December 31, 2024, compared to 2023[19] - The company accrued a liability of $71.1 million related to ongoing litigation with Sandoz Inc. as of December 31, 2024[17] Tax and Equity - The effective income tax rate decreased to approximately 22% for the year ended December 31, 2024, compared to 23% for 2023, due to a decrease in nondeductible acquisition costs[21] - Total stockholders' equity rose to $6,444.0 million in 2024, up from $5,984.8 million in 2023[33] Cash and Assets - Cash, cash equivalents, and marketable investments totaled $4,742.3 million as of December 31, 2024, down from $4,903.9 million in 2023[33] - Total assets increased to $7,364.0 million in 2024, compared to $7,167.0 million in 2023[33] - Total liabilities decreased to $920.0 million in 2024, down from $1,182.2 million in 2023[33] Future Outlook - The company plans to continue expanding its sales and marketing efforts to educate prescribers on its treprostinil products[2] - The company expects continued momentum into 2025 and anticipates readouts from its TETON and ralinepag clinical trials[27] - The increase in sales and marketing expenses for the year ended December 31, 2024, was primarily due to personnel, marketing, and consulting expenses[18] Strategic Initiatives - The company announced FDA clearance for a registration-enabling xenotransplantation study with UKidney[2] - The company aims to innovate for unmet medical needs and expand the availability of transplantable organs as part of its public benefit purpose[25]

Revenue Growth and Sales Performance - Total revenues are primarily driven by sales of commercial products, including Tyvaso DPI, nebulized Tyvaso, and Remodulin, with price increases typically in the single-digit percentages per year [361]. - The company anticipates revenue growth in the near term from continued sales growth of Tyvaso DPI and an increase in the number of patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD) being treated [369]. - Total revenues for 2024 increased by 24% to $2,877.4 million compared to $2,327.5 million in 2023 [376]. - Net product sales of Tyvaso grew by 31% to $1,620.4 million in 2024, up from $1,233.7 million in 2023 [378]. - Tyvaso DPI net product sales increased by $302.5 million in 2024, driven by higher quantities sold and price increases [376]. - Remodulin net product sales rose by 9% to $538.1 million in 2024, primarily due to increased quantities sold in the U.S. [379]. - Orenitram net product sales increased by 21% to $434.3 million in 2024, attributed to higher quantities sold and price increases [380]. - Unituxin net product sales grew by 20% to $238.7 million in 2024, driven by price increases and higher quantities sold [382]. - The U.S. accounted for $2,739.7 million of total revenues in 2024, while the rest of the world contributed $137.7 million [384]. Competition and Market Dynamics - The company is facing increasing competition, including from generic products and new therapies, which may impact sales of its commercial products [357]. - The company faces competitive pressure from established pharmaceutical companies and potential market share erosion from investigational products like Yutrepia [373]. Product Development and Regulatory Approvals - The company is developing a new product, ralinepag, for the treatment of pulmonary arterial hypertension (PAH) and is engaged in research related to organ transplantation technologies [360]. - The timing and outcome of clinical studies and regulatory approvals are critical factors for the company's future product launches and revenue growth [370]. - The FDA cleared the new version of the Remunity Pump, called RemunityPRO, in January 2025, enhancing the delivery options for Remodulin [359]. Financial Performance and Expenses - Total cost of sales for 2024 was $309.7 million, an increase of 20% from $257.5 million in 2023, driven by higher Tyvaso DPI royalty expenses and product costs [388][389]. - Research and development expenses rose to $481.0 million in 2024, an 18% increase from $408.0 million in 2023, primarily due to increased expenditures on manufactured organ projects and licensing payments [390][394]. - Selling, general, and administrative expenses totaled $709.7 million in 2024, a 49% increase from $477.1 million in 2023, largely due to personnel and legal expenses [395][396]. - Share-based compensation expense surged to $144.0 million in 2024, a 268% increase from $39.1 million in 2023, influenced by a 60% rise in stock price and more awards granted [399][400]. - Income tax expense for 2024 was $343.9 million, compared to $289.5 million in 2023, with an effective tax rate of approximately 22% [402]. Cash Flow and Investments - Cash and cash equivalents increased by 41% to $1,697.2 million in 2024 from $1,207.7 million in 2023 [407]. - Total cash and cash equivalents and marketable investments decreased by 3% to $4,742.3 million in 2024 from $4,903.9 million in 2023 [407]. - Net cash provided by operating activities rose by 36% to $1,327.1 million in 2024 compared to $978.0 million in 2023 [408]. - Net cash provided by investing activities increased significantly by 158% to $417.2 million in 2024 from $(719.6) million in 2023 [408]. - Net cash used in financing activities increased by $1,242.9 million in 2024, primarily due to a $1.0 billion share repurchase [411]. Liabilities and Obligations - The outstanding balance under the 2022 Credit Agreement was $300.0 million as of December 31, 2024, classified as a current liability [412]. - Contractual obligations totaled $1,593.0 million as of December 31, 2024, with $1,191.1 million due within one year [413]. - The company had a liability of $140.8 million related to rebates and chargebacks as of December 31, 2024, up from $108.4 million in 2023 [420]. Investment Strategy and Risk Management - The company has invested $3.0 billion in corporate debt securities and U.S. government and agency securities as of December 31, 2024 [424]. - The company maintains a conservative investment approach, focusing on unstructured, highly-rated securities with relatively short maturities to mitigate investment-related risks [425]. - The company actively monitors market conditions and developments specific to the securities in which it invests to manage investment-related risks [425]. - The company acknowledges that while it takes prudent measures to mitigate risks, some risks cannot be fully eliminated due to uncontrollable circumstances [425].