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]

It has been about a month since the last earnings report for United Therapeutics (UTHR) . Shares have added about 9% in that time frame, outperforming the S&P 500.Will the recent positive trend continue leading up to its next earnings release, or is United Therapeutics due for a pullback? Before we dive into how investors and analysts have reacted as of late, let's take a quick look at the most recent earnings report in order to get a better handle on the important catalysts.How Have Estimates Been Moving S ...

United Therapeutics (UTHR) reported $794.4 million in revenue for the quarter ended March 2025, representing a year-over-year increase of 17.2%. EPS of $6.63 for the same period compares to $6.17 a year ago.The reported revenue compares to the Zacks Consensus Estimate of $726.19 million, representing a surprise of +9.39%. The company delivered an EPS surprise of +5.41%, with the consensus EPS estimate being $6.29.While investors scrutinize revenue and earnings changes year-over-year and how they compare wit ...

United Therapeutics (UTHR) Q1 2025 Earnings Call April 30, 2025 09:00 AM ET Company Participants Dewey Steadman - Head, IRMartine Rothblatt - Founder, Chairman & CEOMichael Benkowitz - President & COOLeigh Peterson - Executive Vice President of Product Development & XenotransplantationJames Edgemond - CFO & TreasurerAshwani Verma - Executive Director - SMID Biotech & Biopharma Conference Call Participants Joseph Thome - Managing Director, Senior Biotechnology AnalystJessica Fye - Managing Director & Equity ...

United Therapeutics (UTHR) Q1 2025 Earnings Call April 30, 2025 09:00 AM ET Speaker0 Good morning and welcome to the United Therapeutics Corporation First Quarter twenty twenty five Corporate Update. My name is Torben and I will be your conference operator today. All participants on the call portion of this webcast will be in listen only mode until the question and answer portion of this earnings call. Please note, this call is being recorded. I would now like to turn the webcast over to Dewey Steadman, Hea ...

United Therapeutics (UTHR) came out with quarterly earnings of $6.63 per share, beating the Zacks Consensus Estimate of $6.29 per share. This compares to earnings of $6.17 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 5.41%. A quarter ago, it was expected that this drugmaker would post earnings of $6.10 per share when it actually produced earnings of $6.19, delivering a surprise of 1.48%.Over the last four quarters, the comp ...

Safe Harbor Statement All statements in this presentation are made as of April 30, 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 1995. Forward-looking statements include, among others, statements related to our revenue growth expec ...

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]