UTHR

United Therapeutics reported second quarter results that modestly exceeded Wall Street’s revenue and adjusted EPS expectations, with management highlighting the impact of competitive dynamics in the inhaled prostacyclin market. CEO Dr. Martine Rothblatt emphasized progress in the company’s clinical programs, particularly the ADVANCE OUTCOMES study for ralinepag and the TETON-1 trial for Tyvaso in pulmonary fibrosis. President Michael Benkowitz noted that although revenue was flat sequentially, operational momentum improved, driven by record patient metrics and recent sales force expansion. Management acknowledged that more time is needed for the benefits of differentiated therapies to become evident to physicians. Is now the time to buy UTHR? Find out in our full research report (it’s free). Revenue: $783.3 million vs analyst estimates of $765.9 million (1.9% year-on-year decline, 2.3% beat) Adjusted EPS: $7.27 vs analyst estimates of $7.03 (3.5% beat) Operating Margin: 42.2%, down from 45.6% in the same quarter last year Market Capitalization: $22.11 billion While we enjoy listening to the management’s commentary, our favorite part of earnings calls is the analyst questions. Those are unscripted and can often highlight topics that management teams would rather avoid or topics where the answer is complicated. Here is what has caught our attention. Joseph Thome (TD Cowen) asked about regaining momentum amid increased competition. President Michael Benkowitz described ralinepag and SMI as differentiated offerings expected to stand out due to clinical benefit and patient preference. Jiale Song (Jefferies) requested details on the launch trajectory for new products. Benkowitz reiterated multibillion-dollar potential but said specifics depend on regulatory timing, with more information expected later this year. Jessica Fye (JPMorgan) questioned the achievability of consensus Tyvaso revenue targets for the second half. Benkowitz declined to reaffirm or update guidance, only stating that performance should improve relative to the first half. Ryan Mcelroy (Leerink Partners) inquired about Tyvaso’s future positioning in IPF and the drivers for adopting different formulations. Benkowitz explained that polytherapy is becoming standard in IPF, with Tyvaso likely used in combination with other treatments. Benjamin Burnett (Wells Fargo) asked about data requirements for expanding Tyvaso DPI and SMI into IPF. EVP Leigh Peterson said discussions are ongoing with the FDA, with bridging strategies under consideration and details to be presented at future conferences. In the coming quarters, StockStory analysts will be watching (1) progress on regulatory review and potential approval timelines for ralinepag and nebulized Tyvaso in new indications, (2) the impact of the expanded sales force on commercial performance and physician adoption, and (3) updates on clinical trial milestones, especially the TETON-PPF readout. Execution in organ transplantation and integration of Thymmune Therapeutics will also be important markers of long-term strategy. United Therapeutics currently trades at $515, in line with $518.68 just before the earnings. At this price, is it a buy or sell? See for yourself in our full research report (it’s free for active Edge members). ONE MORE THING: Top 5 Growth Stocks. The biggest stock winners almost always had one thing in common before they ran. Revenue growing like crazy. Meta. CrowdStrike. Broadcom. Our AI flagged all three. They returned 315%, 314%, and 455%, respectively. Find out which 5 stocks it’s flagging this month — FREE. Get Our Top 5 Growth Stocks for Free HERE. Stocks that have made our list include now familiar names such as Nvidia (+1,460% between June 2020 and June 2025) as well as under-the-radar businesses like the once-micro-cap company Kadant (+214% between June 2020 and June 2025). Find your next big winner with StockStory today.

Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Achieved a critical regulatory milestone by resolving FAA policy interpretation issues regarding the H500A motor's continued rotation, clearing the path for certification without engine design changes. Launched eIPP operations with United Therapeutics, representing a one-year pull-forward of commercialization by demonstrating real-world use cases ahead of formal type certification. Unveiled the MV250 military variant, leveraging 80% commonality with civilian aircraft to reduce development costs and accelerate deployment for contested logistics missions. Expanded the component sales business beyond motors and batteries to include flight control computers, securing Horizon Aircraft as a third major OEM customer. Validated hybrid-electric propulsion feasibility through the Electrified Powertrain Flight Demonstration (EPFD) with GE Aerospace, reaching a record altitude of 30,000 feet. Utilized international flight demonstrations in Scotland, Japan, and Hawaii to build operational data and secure new orders, such as the Loganair commitment. Maintained a disciplined production strategy by focusing on vertical integration and supplier qualification rather than immediate manufacturing rate increases. Raised full-year 2026 revenue guidance to $42 million - $50 million, driven by eIPP launch, MV250 demand, and expanded GE Aerospace partnership programs. Targeting a total aircraft backlog of $4 billion by year-end 2026, supported by a current pipeline of 1,001 aircraft valued at $3.9 billion. Anticipating a total of 250,000 nautical miles flown by year-end to bolster the safety record and operational data required for FAA rulemaking. Planning to utilize up to $1 billion in net financing from EXIM Bank to fund capital-intensive industrial investments and extend financial runway. Expects Q3 2026 revenue of $8 million - $12 million with adjusted EBITDA between negative $115 million and negative $125 million due to accelerated production engineering. Transitioned from requirements definition to the implementation phase for CX300 certification following 100% FAA acceptance of Detailed Design Standards. Identified execution risk in the H500A program related to scheduling FAA witnesses for remaining durability and lightning test teardowns. Acquired an AI company focused on validation and verification of safety-critical code to mitigate software certification risks. Formed the ACES consortium with Archer and Macquarie to standardize and deploy up to 250 charging sites, addressing infrastructure as a primary barrier to entry. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. Management confirmed that H500A motor delays did not impact the CX300 timeline, as the programs can be certified concurrently. The CX300 Detailed Design Standards (DDS) collector resolves policy issues upfront, allowing the aircraft to move quickly through the implementation phase. The MV250 targets 'contested logistics' with a 2,000-pound payload and 170-knot cruise speed, outperforming traditional rotorcraft in speed and range. BETA is pursuing a rapid prototyping contract over the next year, leveraging commercial certification progress to meet military acquisition reform goals. Component sales (motors, batteries, flight control computers) are described as 'sticky' revenue streams with high design-in barriers. Management expects the component business to carry margins between 40% and 60%, with flight control computers potentially exceeding that range. Higher energy density will be traded for increased payload and volume rather than just range, specifically to meet the needs of feeder fleets like UPS. Management noted that doubling range effectively quadruples accessible city pairs, significantly expanding the total addressable market.

Liquidia Corporation LQDA reported second-quarter 2026 earnings per share (EPS) of 74 cents, which topped the Zacks Consensus Estimate of 70 cents. In the year-ago quarter, the company reported a loss per share of 49 cents. Total revenues surged to $171.7 million from $8.8 million in the year-ago quarter and beat the Zacks Consensus Estimate of $165 million. The quarterly performance was powered by continued adoption of lead drug Yutrepia. However, shares were down 10% following the second-quarter results. Shares of LQDA have surged 128.5% year to date compared with the industry’s growth of  5.9%. Image Source: Zacks Investment Research Yutrepia is a dry-powder inhaled formulation of treprostinil delivered through a compact, easy-to-use device. It is approved to treat pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD) to improve exercise capacity. Yutrepia net product sales reached $170.4 million in the second quarter, up from $6.5 million a year earlier driven by higher Yutrepia volume. Product sales increased 31.0% sequentially. LQDA began commercial shipments of Yutrepia in the United States in June 2025, shortly after receiving full FDA approval on May 23, 2025. As of July 31, 2026, Liquidia had received approximately 5,900 unique prescriptions since launch and started more than 5,000 patients on therapy. More than 1,100 physicians had prescribed Yutrepia since launch as of July 31, and more than 30% of them had written prescriptions for at least five patients. The prescription-to-start conversion rate remained above 85%. LQDA also generates service revenues through its promotion agreement with Sandoz, under which the companies share profits from U.S. sales of Treprostinil Injection. Service revenues totaled $1.3 million in the second quarter, down from $2.3 million in the prior-year quarter mainly due to unfavorable gross-to-net adjustments. Research and development expenses skyrocketed 185% year over year to $17.2 million. The increase primarily reflected higher L606 program spending, greater Yutrepia research activity and increased personnel costs. Selling, general and administrative expenses increased 48.0% to $57.4 million, caused by higher personnel costs, increased stock-based compensation expenses, and commercial and consulting costs. Net income was $74.7 million in the quarter. The company had reported a net loss of $41.6 million in the year-ago quarter. Strong Yutrepia sales drove its fourth consecutive quarter of increasing profitability. Cash and cash equivalents totaled $284.2 million as of June 30, up from $222.8 million at the end of the first quarter. Management said cash flow from the commercial business allows Liquidia to fund expanded clinical investment alongside ongoing commercialization. Liquidia now has 10 clinical studies, between Yutrepia and L606, either underway or planned to start over the next 12 months. L606 is a twice-daily, liposomal formulation of treprostinil delivered through a next-generation nebulizer and is being evaluated in PAH and PH-ILD. The phase III Re-Spire study on L606 is currently enrolling. The company also plans to explore Yutrepia in additional indications, including pulmonary hypertension associated with chronic obstructive pulmonary disease, idiopathic pulmonary fibrosis (IPF), progressive pulmonary fibrosis and Raynaud’s phenomenon associated with systemic sclerosis. Liquidia said it is confident that it is on track for more than $1 billion in net revenues in 2027 while continuing to grow profitability. Management expects revenues to keep increasing in line with the quarterly growth trajectory seen since launch. LQDA expects second-half 2026 R&D spending to be double the first-half level and to increase again in 2027 as Re-Spire enrollment and other studies ramp up. SG&A expenses are expected to rise as the company scales commercially, with certain costs increasing in line with revenues. LQDA topped both revenue and earnings estimates in the second quarter. Yutrepia has emerged as a leading player in the inhaled prostacyclin market for PAH and PH-ILD. Liquidia Corporation price-consensus-eps-surprise-chart | Liquidia Corporation Quote Liquidia’s solid commercial performance is strengthening its financial position, with cash and equivalents reaching $284.2 million at quarter-end. The differentiated tolerability and dosing profiles of both Yutrepia and L606 should enable the company to tap into incremental opportunity in the PAH market. Management expects revenues to exceed $1 billion in 2027, supporting a favorable long-term growth outlook. Yutrepia’s primary competitor is United Therapeutics' UTHR Tyvaso (treprostinil), the long-established inhaled therapy approved for PAH in 2009 and PH-ILD in 2021. United Therapeutics highlighted two major regulatory filings — ralinepag tablets for PAH and nebulized Tyvaso for IPF — as potentially significant catalysts for long-term growth. Additional planned filings for ralinepag DPI and treprostinil SMI could further expand UTHR’s pipeline and growth opportunities. LQDA currently carries a Zacks Rank #1 (Strong Buy). Another top-ranked stock in the biotech sector is Repligen RGEN, which carries a Zacks Rank #1. You can see the complete list of today’s Zacks #1 Rank stocks here. Over the past 60 days, estimates for Repligen’s 2026 earnings per share have risen from $1.99 to $2.06, while those for 2027 EPS have increased from $2.57 to $2.62 during the same time. RGEN shares have gained 1.1% year to date. Repligen’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 16.80%. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Liquidia Corporation (LQDA) : Free Stock Analysis Report United Therapeutics Corporation (UTHR) : Free Stock Analysis Report Repligen Corporation (RGEN) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

This article first appeared on GuruFocus. Release Date: August 12, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Revenue in Q2 2026 was $14.7 million, exceeding guidance and up 146% year-over-year, driven by EPFD program and charger deliveries. Backlog reached 1,001 aircraft valued at $3.9 billion, nearly hitting the $4 billion year-end target by mid-year. Achieved significant certification milestones, including resolving FAA policy issues for the H500A motor and completing the CX-300 requirements definition phase. Launched EIPP operations with United Therapeutics, becoming the first company to do so, and expanded charging network to 138 sites with the ACES consortium targeting 250 more. Expanded defense and component sales, including the MV-250 unveiling, flight control computer sales to Horizon, and growing partnerships with GE Aerospace and General Dynamics. Adjusted EBITDA remained deeply negative at -$110 million in Q2, with full-year guidance widened to -$400 million to -$445 million. Operating expenses were high at $166 million, reflecting continued heavy R&D and G&A spending. Max demonstrated production rate remained unchanged, indicating a deliberate but slow ramp-up in manufacturing. The company faces execution risks in certification, with remaining tests and FAA approvals still pending for the H500A and CX-300. Cash burn is significant, though the planned $1 billion EXIM financing is intended to extend runway, but it is not yet finalized. Warning! GuruFocus has detected 2 Warning Sign with BETA. Is BETA fairly valued? Test your thesis with our free DCF calculator. Q: Given the significant progress on the H500A motor and the CX-300 requirements definition phase, could the certification of these two programs end up being closer together than previously expected, or is there a dependency that creates a lag?A: Kyle Clark, Founder and CEO: The intentional year split between the H500A and CX300 is not necessary, and they can be concurrently certified. The H500A's policy interpretation issues did not affect the CX300 program. We are in a strong position to move through TIA and flight testing, and the H500A could be concurrently certified if needed. The FAA's acceptance of our detailed design standards collector for the CX-300, a first in the AAM industry, resolves policy issues upfront, allowing us to move quickly. Q: What applications and use cases will you target for the MV-250 military aircraft, how quickly can it be deployed, and what is the expected selling price?A: Kyle Clark, Founder and CEO: The MV-250 is a multi-mission platform focused first on contested logistics, carrying a 2,000-pound payload over a 250 nautical mile tactical range. It can also be used for CASEVAC, Medevac, and launched effects, with a 13-hour loiter time. Its speed, range, and autonomous capabilities allow it to operate in riskier areas without a pilot. The aircraft has a low logistics tail, requiring about 1/10 of the crew of a legacy rotorcraft. We are targeting a rapid prototyping contract with the Army within the next year. Q: What is the most significant aspect of the joint charger announcement with Archer, and how do you expect the charging segment to grow, especially with EIPP now started?A: Kyle Clark, Founder and CEO: The partnership is about coalescing around a common standard and strategically deploying chargers. Archer brings unique insight into high-value metropolitan endpoints, while Beta provides the hardware and insight into cargo and medical routes. This creates a more powerful network. Herman Cuto, CFO, added that the consortium will grow as Beta has the only certified CCS charger suitable for electric aviation, and the immediate focus is identifying strategic locations and timelines. Q: Can you provide an update on the H500A engine certification, specifically what is left in phase four over the next 6 to 12 months?A: Kyle Clark, Founder and CEO: We are in pure execution mode. We have completed a large number of tests, including lightning and durability testing with associated teardowns overseen by the FAA. What remains are mechanical tests, dual-160 tests, and longer-term tests. We have over 80,000 hours of runtime on our motors, which is far more than typical turbine engines. The remaining work is repeating tests in front of the FAA, getting sign-off on methods, and ultimately receiving the type certificate. Q: How should we think about the completion of the CX-300 phase four, and what are the nuances of the testing process?A: Kyle Clark, Founder and CEO: The CX-300 certification is a well-known process. The three new technologiespropulsion, batteries, and fly-by-wirehave had their risks retired. The fly-by-wire system is enveloped by Part 25 standards, and battery issue papers are accepted. We have already flown with FAA test pilots to get early feedback on human factors. The remaining work involves conforming article structural tests, durability tests, and flying qualities tests. We have 80% commonality with the VTOL aircraft, and we adopt higher standards early to retire risk. Q: How are conversations with potential customers progressing for the MV-250, and is M&A on the roadmap to support defense applications?A: Kyle Clark, Founder and CEO: The demand signal for the MV-250 was strongly validated at Farnborough, with keen interest from the highest levels of the U.S. Military and foreign military interest. We are working towards a rapid prototyping contract. On M&A, we recently acquired an AI company focused on the validation and verification of safety-critical code within our flight controllers, addressing the hardest problem in the industrycertification. This is part of our strategy to focus acquisitions on the most challenging issues. Q: Can you discuss the aftermarket profit opportunity, and how higher energy density batteries may impact customer placement and battery margins?A: Kyle Clark, Founder and CEO: Higher energy density batteries increase aircraft performance and payload, which is what customers like UPS want. They don't necessarily want more range; they want more payload and volume. As energy density improves, the accessible city pairs increase exponentially, which is good for customers and Beta. Herman Cuto, CFO, added that the component business typically carries a 40% to 60% margin, with flight control computers carrying a much higher margin. Q: Can you provide an update on the hybrid electric engine partnership with GE Aerospace and the future of that collaboration?A: Kyle Clark, Founder and CEO: We have multiple programs with GE, including the hybrid turbo generator built around the CT7 for the MV-250. This partnership covers power electronics, electromagnetics, and controls. The collaboration is proving high-altitude, high-speed, high-temperature, and high-voltage capabilities. The level of integration between GE, Beta, and Sikorsky is extremely positive, and the rate of technical development and flight demonstrations is exceptional. Q: Can you elaborate on the opportunity for component sales beyond flight control computers and motors, and what other components have a viable market?A: Kyle Clark, Founder and CEO: We have sold motors, propellers, inverters, high-voltage systems, flight control computers, flight controls, batteries, and lightweight data acquisition systems. These sales are sticky because customers design their control laws around our hardware. Our strategy is to get designed in early, generate margin, and grow with the programs. Herman Cuto, CFO, noted that the component business carries a 40% to 60% margin, with flight control computers being significantly higher. Q: What should we expect from the EIPP operations going forward, and will they be similar to the initial demonstration?A: Kyle Clark, Founder and CEO: The initial EIPP flight was executed within hours of the contract, demonstrating readiness. Now we are expanding to other jurisdictions and moving into Part 135 operations with a repeatable cadence of multiple flights per day. Herman Cuto, CFO, added that over the next four to six weeks, we expect Louisiana and Texas to come online with customers like Metro, Bristow, and Future Flight Global, For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Image source: The Motley Fool. Friday, Aug. 7, 2026 at 9:00 a.m. ET Chairperson and Chief Executive Officer - Martine Rothblatt President and Chief Operating Officer - Michael Benkowitz Chief Financial Officer and Treasurer - James Edgemond Executive Vice President of Product Development and Xenotransplantation - Leigh Peterson Executive Vice President of Strategic Development - Pat Poisson Investor Relations - Harrison Silvers Operator: Good morning, and welcome to the United Therapeutics Corporation Second Quarter 2026 Corporate Update. My name is JL, and I'll be your conference operator today. [Operator Instructions] Please note that this call is being recorded. I'll now turn the webcast over to Harry Silvers, Investor Relations at United Therapeutics. Harrison Silvers: Thank you, JL. Good morning, everyone. It is my pleasure to welcome you to the United Therapeutics Corporation's Second Quarter 2026 Corporate Update Webcast. Remarks today will include forward-looking statements representing our expectations or beliefs regarding future events. These statements involve risks and uncertainties that may cause actual results to differ materially. Our latest SEC filings, including Forms 10-K and 10-Q, contain additional information on these risks and uncertainties. We assume no obligation to update forward-looking statements. Today's remarks may discuss the progress and results of clinical trials or other developments with respect to our products. These remarks are intended solely to educate investors and are not intended to serve as the basis for medical decision-making or to suggest that any products are safe and effective for any unapproved or investigational uses. Full prescribing information for the products is available on our website. Accompanying me on today's call are Dr. Martine Rothblatt, our Chairperson and Chief Executive Officer; Michael Benkowitz, our President and Chief Operating Officer; James Edgemond, our Chief Financial Officer and Treasurer; Dr. Leigh Peterson, our Executive Vice President of Product Development and Xenotransplantation; and Pat Poisson, our Executive Vice President of Strategic Development. Note that Martine Rothblatt, James Edgemond and I will participate in a fireside chat and one-on-one meetings at the Wells Fargo Healthcare Conference, September 8 in Boston; the Cantor Fitzgerald Global Healthcare Conference in New York on September 9. Pat Poisson will join us for the Morgan Stanley Healthcare Conference in New York on September 14. And then lastly, the Bernstein Third Annual Healthcare Forum in New York on September 23. Our scientific, commercial and medical affairs teams will be present at the European Respiratory Society Congress in Barcelona, September 5 through 9, and the American College of Chest Physicians CHEST 2026 Annual Meeting in Phoenix, October 18 through 21. Now I will turn the webcast over to Martine for an overview of our development pipeline and business activities. Martine? Martine Rothblatt: We have slides available for reference, and I encourage you to review those at your leisure. I'm not going to speak directly to the slides. The first half of 2026 has been one of the most consequential periods in United Therapeutics' history. First, we delivered exceptional clinical results from our ADVANCE OUTCOMES study, demonstrating ralinepag's potential to become a major new oral therapy for patients with PAH. Then we unblinded TETON-1, which surpassed the impressive TETON-2 results we reported last September. Together, these results put us in an extraordinary position, a new molecule advancing toward the PAH market and a potential new indication for nebulized Tyvaso in IPF, representing an opportunity meaningfully larger than our currently approved markets and a new option for patients. With these highly statistically significant clinical results, we recently submitted to the FDA what we believe are two of the most important new drug applications in rare pulmonary disease: the sNDA for nebulized Tyvaso in IPF and the NDA for ralinepag in PAH. And we are not stopping there with additional filings planned later this year, including an IND for ralinepag DPI and an NDA for treprostinil SMI. We are moving with urgency toward what we believe will be a pivotal change in our growth trajectory as we plan to bring pioneering advanced inhalation technologies to patients. We expect potential approvals in 2027 for nebulized Tyvaso in IPF, ralinepag in PAH and the SMI device in PAH and PH-ILD. These are not incremental opportunities. We believe they are multibillion-dollar catalysts with the potential to redefine patient treatment paradigms, improve outcomes for patients and fundamentally transform our growth profile and competitive position. Looking further ahead, enrollment in our TETON-PPF trial is nearly complete, paving the way for another substantial Phase III readout in the back half of 2027. Based on the successful TETON-1 and TETON-2 studies as well as the similarities in underlying fibrosis and disease progression between IPF and PPF, we have a high degree of confidence in our ability to report another positive outcome. If successful, TETON-TPF would open the door to an even larger opportunity, at least double that of IPF, and position nebulized Tyvaso to become a leading therapy for patients with pulmonary fibrosis. Turning to our organ pipeline, we continue to make strong progress toward our goal of expanding the availability of transplantable organs. The UKidney EXPAND study continues to make great progress with completion of the initial six-patient cohort expected later this year. In parallel, we soon anticipate initiating the UThymoKidney EXTEND registration-enabling study. Lastly, with recent clearance from the FDA, we are working to commence our EXPRESS-UHeart study. Moreover, by the end of this year, we will complete construction of our 2 additional commercial-scale DPFs in Minnesota and Texas. With 3 authorized clinical trials, United Therapeutics is not just participating in the future of xenotransplantation; we are leading it. We believe this work can redefine organ transplantation, save countless lives and create one of the most significant growth opportunities in our company's history. Our deep organ pipeline represents a bold and differentiated extension of United Therapeutics' mission with the potential to transform how patients access life-saving organs and how United Therapeutics will create substantial value over the long term. We will be sharing with you more details about these programs as each moves through their development time lines. Our ability to pursue these opportunities is supported by a disciplined approach to capital allocation through our budget algorithm, which has positioned us near the top of our industry in operating efficiency. We have also been thoughtful in deploying capital toward internal growth objectives while remaining mindful of returning capital to shareholders. As an example, we recently deployed capital to acquire Thymmune Therapeutics, adding a promising thymus-based regenerative medicine platform that fits squarely within our mission. This acquisition broadens our organ alternative strategy and strengthens our ability to pursue therapies that could restore immune function for patients with serious diseases. We see tremendous potential ahead, and we're excited to welcome the Thymmune team to United Therapeutics. To close, we believe United Therapeutics is entering a defining era, one shaped by scientific ambition, innovative platforms and a pipeline with the potential to transform care across some of the most challenging areas of medicine. As these opportunities advance, we see a future in which our impact on patients, our industry and our growth trajectory can reach an entirely new level, making United Therapeutics a growth story unlike any other in biotech. And with that, I'll turn the call over to our President, Michael Benkowitz, who will provide an overview of our commercial performance for the quarter. Mike? Michael Benkowitz: Thank you, Martine, and good morning, everyone. For the second quarter of 2026, we generated approximately $783 million in total revenue, essentially flat with the first quarter. While these results were below our expectations, they do not change our confidence in the strength of our business, the opportunities in front of us or our ability to create substantial value over the coming years. I want to start by acknowledging something directly. Over the last several quarters, we understand investors have been looking for a faster acceleration in growth, and we recognize that confidence is earned through execution, not projections. So our focus is on improving results. As we evaluate the current state of the business, we believe the underlying fundamentals are strong, and we believe we are positioned to deliver improved performance in the second half of the year. Simply put, we exited the second quarter with considerably more momentum than the reported revenue line alone would suggest. Based on the trends we're seeing today, we expect the second half of 2026 to be stronger than the first half of 2026, and we remain focused on accelerating revenue growth as we move through the balance of the year. That said, we are not reaffirming or updating any prior revenue growth expectations for 2026 today. Turning to Tyvaso, total revenue for the quarter was $453 million. Nebulized Tyvaso remained pressured by competitive dynamics within the inhaled prostacyclin category as patients and providers evaluate an increasing number of treatment options. We expected this market to become more competitive over time, and that's precisely what we are seeing today. Tyvaso DPI, meanwhile, continued to demonstrate growth and, more importantly, exited the quarter with what we view as significant underlying momentum. As we have discussed previously, quarterly sales are not always the best measure of underlying demand. Starts, referrals, total patients and commercial patients all reached record levels exiting the quarter. Those metrics give us confidence not only in the durability of the franchise but also in our ability to translate that momentum into stronger commercial performance over the second half of the year. So we remain confident in the strength and long-term value of our existing commercial portfolio. Our conviction is grounded in what we believe are highly differentiated therapies that offer meaningful advantages in efficacy, convenience, dosing and long-term tolerability. We continue to believe these characteristics matter deeply to patients and providers and position us well for sustained growth. Recognition of these benefits, particularly in a highly competitive environment, are taking time to crystallize with physicians. However, we believe our commercial strategy has us well positioned to accelerate that process, and the underlying trends we are seeing reinforce our belief that we are moving in the right direction. As we discussed last quarter, we significantly expanded, that is roughly doubled, our sales force. Those representatives entered the field in early July and are already increasing our reach and frequency of engagement with physicians across both PAH and PH-ILD. We recruited an exceptionally strong team with deep, relevant experience, and we expect their efforts to meaningfully enhance awareness of our therapies, accelerate adoption and support stronger commercial performance over time. To round out this section, we believe the combination of record patient metrics, increased commercial reach, the strength of our differentiated portfolio and growing physician awareness positions us well to accelerate performance in the second half of the year. At the same time, it's important to recognize that our story is not solely about the next quarter or the next year. We continue to believe that we have 2 potentially transformative opportunities in front of us. First, nebulized Tyvaso and IPF; second, ralinepag in PAH. Both represent areas of substantial unmet need, both have the potential to become multibillion-dollar opportunities and both have the potential to further strengthen our leadership position in respiratory and cardiopulmonary disease. For Tyvaso in IPF, we continue to see strong interest from physicians following the TETON results, and we remain excited about the potential impact this therapy could have for patients with limited treatment options today. For ralinepag, we believe the opportunity to introduce the first once-daily oral prostacyclin could represent a meaningful advancement for patients and providers seeking a differentiated treatment option. We have previously projected a $4 billion revenue run rate by the end of 2027 with our existing commercial portfolio. We still see a path to achieve this, although it has certainly narrowed. Factoring in some of the revenue from our anticipated IPF and ralinepag launches next year should get us there and beyond. Our strategy is straightforward. We are focused on executing and growing the business we have today while simultaneously preparing the organization for what we believe could be 2 important future launches. We do not view these future opportunities as replacing our current growth story. Rather, we view our current commercial portfolio as providing a strong, durable and growing foundation, while Tyvaso and IPF and ralinepag offer meaningful upside beyond that foundation. That combination gives us confidence not only in the long-term potential of United Therapeutics but also in our ability to accelerate growth in the near term and create value across multiple time horizons. Before I close, I want to share with our investors something that is an important part of our culture and how we work. Across the company, we have a rallying cry called LTFI, which stands for Lock The F In. While there are certainly exciting opportunities on the horizon in 2027 and beyond, LTFI is a reminder that our responsibility is not to focus on future possibilities at the expense of present execution. We have patients, providers, shareholders and fellow Unitherians counting on us today. LTFI is our commitment to all of those stakeholders. It's a reminder that, while we are excited about what may come next, our focus remains on what we must deliver now. And we believe the trends we are seeing today position us to do exactly that. We are focused; we are accountable. We are committed to accelerating performance in the second half of the year. And we will continue to be LTFI as we deliver for patients, providers, our colleagues and our shareholders. With that, I'll pass the call back to Harry to start our Q&A session. Harry? Harrison Silvers: Great. Thank you, Michael, and thank you, Martine, for the excellent overviews this morning. Before I give this over to JL to start the Q&A session, I would just like to remind those on the call asking questions, please try to limit yourselves to one question with respect to the long queue that we have. Operator: [Operator Instructions] Your first question comes from the line of Joseph Thome of TD Cowen. Joseph Thome: Maybe just as we're thinking about some of the other offerings, either ralinepag in PAH or the Tresmi in PAH and PH-ILD, I guess, how much do you think you're going to be able to kind of recapture maybe some of the momentum that you did lose by increased competition in the space? Yes, just kind of your thoughts around that. Harrison Silvers: Thanks, Joe. I'm going to pass it to Michael to answer that question. Michael Benkowitz: Yes. So I think in terms of ralinepag, as I think both Martine and I said in our opening remarks, we look at that as a multibillion-dollar opportunity. We've talked about the notion that this is a super-prostacyclin. We think the data that we saw in the ADVANCE OUTCOMES study certainly support that. I think the initial reactions and feedback we're getting from physicians is very positive. And I think the combination of -- it's not just it being a once-daily oral prostacyclin, which we think is differentiated in and of itself. But more importantly, actually, the clinical benefit that we saw in the trial, I think, is really going to position us well for an exciting launch and, like we said, a multibillion-dollar opportunity. I think -- similarly with SMI, I think we look at SMI as really being a really differentiated way to deliver inhaled therapies across eventually all of our indications. And so I think when -- we believe that it's going to be, I think, very well received by both the physicians and the patients. We think there could be potentially some tolerability benefits. And so we look at that as really being, again, another way to kind of differentiate ourselves relative to competition. Operator: Your next question comes from the line of Roger Song of Jefferies. Jiale Song: Great. Also along the line, in terms of those new product launch, appreciating the 2027 guidance reaffirmation. How should we think about the launch ramp-up for those new products, including the nebulized IPF, Tyvaso IPF and then ralinepag and Tresmi? Harrison Silvers: Thanks, Roger. Michael will answer that question for you. Michael Benkowitz: Sure, Roger. Thanks for the question. I think we're going to have more information to share on launch trajectory or launch ramps as we get to the back half of the year or early 2027. I think we're working through that now. As we said, I think we certainly look at both as being multibillion-dollar opportunities. I don't think that's really in question. How quickly we get there? I think we're kind of working through that. And then obviously, a lot of that's going to depend on when we're able to launch. Do we get priority review or not? So I think as we get a little bit more information on the status of our regulatory filings and the timing of when we could see an approval and just kind of continue doing kind of our work on the commercial side to prepare our launch trajectory, we'll have more information to share later this year, as I said. Operator: Your next question comes from the line of Jessica Fye of JPMorgan. Jessica Fye: I guess this one is for Michael, and I appreciate the comments on how you see the business set up for a stronger back half than first half. I guess just in the interest of getting consensus numbers in the right place for this sort of period prior to the IPF launch, I think back half Tyvaso consensus is for about $1.047 billion of revenue. Is that achievable based on kind of the larger sales force and the other dynamics you mentioned? Or should the Street be thinking about that number a little bit differently? Just want to make sure expectations are in the right place for the next couple of quarters. Harrison Silvers: Thanks for the question, Jess. Good to hear from you this morning. We got Michael to answer that. Michael Benkowitz: Yes. So Jess, as we said, we're not really kind of reaffirming or updating anything at this point. As I said in my opening remarks, we expect it to be -- we expect the second half to be stronger than the first half. And I think we're just going to kind of leave it at that for right now. Operator: Your next question comes from the line of Roanna Ruiz of Leerink Partners. Ryan Mcelroy: You have Ryan on for Roanna. Maybe pivoting over to IPF. Coming out of ATS and your conversations with physicians, can you kind of talk about your expectations for where you think Tyvaso is going to be positioned in the IPF treatment landscape? And between nebulizer, DPI and SMI, what do you think is really the main driver of future prescribing for this franchise? Harrison Silvers: Ryan, thanks for the question. We got Michael again for you. Michael Benkowitz: Yes. So just to make sure everybody is clear, when we launch into IPF next year, we're just not launching with the nebulized Tyvaso -- we still have -- have some engagement to do with the FDA to understand exactly what we're going to need to do to get an approval in that indication for both DPI and SMI. So the launch next year will solely be nebulized in IPF. And I think it's -- the feedback we're getting is, as I said in my remarks, really, I think, a lot of excitement around IPF, around the data, around the treatment option. And so I think as we've kind of talked to some of the top KOLs, they said whether they use it first line or whether they add it on, it's really going to be patient-dependent. But I think they all said ultimately, it doesn't -- it probably doesn't really even matter because I think what they're saying is IPF is moving towards what we're seeing in PAH in terms of a polytherapy approach to treating these patients. And so I think the vast, vast majority of the docs we're talking about have said they're going to use Tyvaso in combination with other products. And so whether it's sequenced first or second, it kind of doesn't matter, but they're going to quickly get to polytherapy. Operator: Your next question comes from the line of Ben Burnett of Wells Fargo. Benjamin Burnett: I just wanted to follow up just on IPF. And just what's your expectation for the type of data that you would need to generate to get the DPI and the SMI into IPF? Like would this just be bridging data? Or would you anticipate you need to generate any more efficacy data? Harrison Silvers: Ben, thanks. I think for part of the question with the SMI, perhaps Pat can address that. And maybe, Leigh, if you want to add any commentary on bridging to the Tyvaso DPI. Patrick Poisson: Yes, you want me to start, Harry? Harrison Silvers: Yes. Patrick Poisson: Yes. I mean we're engaged with FDA to have those discussions to understand what they need to see for Tyvaso DPI. So it's yet to be determined. And I'll pass it over to Leigh to maybe add some color to the clinical approach. Leigh Peterson: Yes. So as Pat said, we're engaging with FDA. We have some good ideas for bridging, and with regard to our current population that's enrolled as far as potentially new starts, we have a proposed strategy that we'll be presenting to them, and we look forward to seeing what they have to say, similar to what we've done in the past with regard to bridging. So -- and that goes for both SMI and DPI. Operator: Your next question comes from the line of Ashwani Verma of UBS. Ashwani Verma: Can you talk about the sales force expansion heading into the IPF and ralinepag potential approval? How much of the sales force is already deployed? And I'm assuming the physician calling point is a little bit different. So how much does that help with the current Tyvaso indications? Harrison Silvers: Thanks for the question, Ash. Good to hear from you this morning. Michael can take that one for you. Michael Benkowitz: Sure, Ash. Yes. So we -- what we've talked about in the past and what I mentioned in my opening remarks is our plan has always been to roughly double the size of the sales force to support both the IPF and ralinepag indications. And we've done that. So we accelerated that process, made that decision earlier this year to accelerate that process and get those sales reps out in the field by July 1, which we've essentially done. I mean we still got maybe one or two openings that we have to fill. But essentially, we've expanded the sales force. Now of course, ralinepag and IPF are not approved indications. So they're not out detailing those two products or indications, but we're using them, I think, to really kind of get a little bit more leverage and a little bit greater reach and frequency to providers in our approved indications of PAH and PH-ILD. And so that -- like I said, we have them out in early July, and so they're out and starting to call on those physicians. I think the -- your point on the call point is it's a little bit different in the sense that with IPF, those patients are much more in the community than the academic centers, and that was really sort of the rationale behind expanding the sales force in IPF is because we knew we were going to have to go deeper into the community than we previously have had to because that's where those patients reside. So it's not necessarily a different physician. It's just a question of getting deeper into the community than we currently have. Operator: Your next question comes from the line of Olivia Saunders of Cantor. Olivia Brayer: Are you able to put some numbers around how big of a revenue opportunity you see IPF being, maybe, kind of, overall franchise at peak? And just given how impressive JASCAYD's uptake has been so far, how does that impact the way that you guys are thinking about your own launch just given some of the differences between JASCAYD and Tyvaso? I also did want to see if there's anything you can say around baseline characteristics of the TETON PPF patients enrolled so far, just given that you're hitting that 95% plus and whether you guys plan to publish those details after enrollment wraps. Harrison Silvers: Thanks, Olivia, for your questions. I think Michael will address the commercial expectations side of it, and then maybe Leigh can answer the part on PPF patient characteristics. Michael Benkowitz: Yes. So I think, Olivia, on your first question in terms of opportunity, as I said, I think to an earlier question, I think we'll start to provide more information on kind of all of that peak potential and ramp and trajectory and all of that as we get to the second half -- deeper into the second half of the year. The -- yes, JASCAYD has had, I think, a very strong launch. I mean there's no question. And so we're certainly -- we're certainly looking at that. We're looking at what OFEV and Esbriet and all those things factor into kind of how we're thinking about the Tyvaso trajectory. But like I said, we'll have more details to share on that as we get to kind of later part of this year, early 2027. Harrison Silvers: Leigh, do you want to take the PPF question? Leigh Peterson: Yes. So as we mentioned, our PPF study enrollment is actually quite a bit ahead of schedule, finishing up very, very shortly. And yes, we will present the baseline characteristics of those -- that patient population in upcoming conferences. And so basically, that's your answer. Yes, you will be seeing those. We look forward to sharing. Operator: Your next question comes from the line of Lisa Walter of RBC Capital Markets. Lisa Walter: Just a quick one on the IPF sNDA filing. Wonder if you could share the date when it was filed and when we could hear about acceptance of the filing and whether you think there is potential for priority review? Any color here would be helpful. Harrison Silvers: Thanks, Lisa. Always happy to take your questions. I think Leigh can answer that one. Leigh Peterson: Yes. So we submitted late June, and we will be learning shortly if we're able to receive priority review, probably -- well, I can't really give a specific date on that. But again, that would be a six-month review period if that is received and 10 months otherwise. So that's basically what I can say right now. Harrison Silvers: I think that was perfect, Leigh. Operator, you can go ahead and wrap up the call. Operator: Thank you for participating in today's United Therapeutics Corporation earnings webcast. A rebroadcast of this webcast will be available for replay for one week by visiting the Events and Presentations section of the United Therapeutics Investor Relations website at ir.unither.com -- that is -- sorry, that is at ir.unither.com. You may now disconnect. 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This article is a transcript of this conference call produced for The Motley Fool. While we strive for our Foolish Best, there may be errors, omissions, or inaccuracies in this transcript. As with all our articles, The Motley Fool does not assume any responsibility for your use of this content, and we strongly encourage you to do your own research, including listening to the call yourself and reading the company's SEC filings. Please see our Terms and Conditions for additional details, including our Obligatory Capitalized Disclaimers of Liability. The Motley Fool has positions in and recommends United Therapeutics. The Motley Fool has a disclosure policy. United Therapeutics (UTHR) Q2 2026 Earnings Call Transcript was originally published by The Motley Fool

United Therapeutics UTHR reported second-quarter 2026 earnings per share (EPS) of $7.27, beating the Zacks Consensus Estimate of $6.82. Bottom line increased 13.4% year over year. United Therapeutics markets four products for pulmonary arterial hypertension (PAH): Tyvaso, Orenitram, Adcirca and Remodulin. It also markets Unituxin for the treatment of pediatric patients with high-risk neuroblastoma. Revenues in the quarter totaled $783.3 million, which missed the Zacks Consensus Estimate of $803 million. Top line declined 2% year over year. Year to date, shares of United Therapeutics have rallied 6.5% against the industry’s 3.9% decline. Image Source: Zacks Investment Research A key driver of the company’s top line is Tyvaso products. United Therapeutics markets two versions of Tyvaso, Tyvaso dry powder inhalation (DPI) and nebulized Tyvaso. Both versions are approved for the treatment of PAH and pulmonary hypertension associated with interstitial lung disease (PH-ILD) indications. Combined Tyvaso sales totaled $452.6 million, down 4% year over year due to lower revenues from nebulized Tyvaso. Tyvaso sales fell short of the Zacks Consensus Estimate of $469 million. Tyvaso DPI generated revenues of $326.6 million, climbing 4% year over year due to an increase in patient demand and some pricing benefits. Revenues from nebulized Tyvaso (treprostinil) were $126 million, down 18%, largely due to reduced U.S. demand despite modest price increases. Sales of Orenitram rose 1% year over year to $125.7 million. Remodulin (including Remunity Pump) sales declined 6% year over year to $126.3 million primarily due to lower demand in the United States despite an increase in international revenues. Unituxin sales were up 12% year over year to $65.2 million. Adcirca sales were $6.7 million, roughly consistent with the prior-year quarter. Research and development expenses were $146.3 million in the quarter, up 9% year over year, mainly due to higher spending on clinical programs and a rise in the fair value of contingent consideration liabilities related to acquired manufactured organ and organ alternative projects. Selling, general and administrative expenses declined 3% year over year to $206.7 million in the quarter. As of June 30, 2026, UTHR had cash, cash equivalents and investments of $3.8 billion compared with $3.5 billion as of March 31, 2026. United Therapeutics is pursuing significant label expansion opportunities for Tyvaso in broader pulmonary fibrosis settings, including idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF). The company's IPF development program consists of two late-stage parallel studies, TETON-1 (conducted in the United States and Canada) and TETON-2 (internationally). The TETON studies evaluated nebulized Tyvaso for the treatment of patients with IPF, a devastating lung disease with limited treatment options. Based on data from the studies, UTHR submitted a supplemental new drug application to the FDA in June for the approval of nebulized Tyvaso in IPF. If the drug is approved for this indication, United Therapeutics expects Tyvaso sales in the IPF indication to exceed the drug’s sales in the PAH indication. Patient enrollment is ongoing in the phase III TETON PPF study evaluating the drug in patients with PPF. Top-line data is expected in the second half of 2027. The company is developing Tresmi, an investigational inhaled treprostinil solution delivered via a soft mist inhaler for the treatment of PAH and PH-ILD. The therapy is designed to reduce coughing by up to 90% compared with Tyvaso DPI. UTHR plans to submit regulatory applications for both indications in 2026, with a commercial launch in 2027, subject to regulatory approval. Another promising late-stage pipeline asset is ralinepag, a potential next-generation growth driver for the company’s PAH franchise. The selective prostacyclin receptor agonist is being developed in two formulations, an oral version and a DPI version (RAL-DPI). The growth of oral ralinepag increased significantly following positive data from the pivotal phase III ADVANCE OUTCOMES study in patients with PAH in March 2026. The study met its primary and secondary endpoints. Based on the data, United Therapeutics recently submitted a new drug application for oral ralinepag to the FDA. Beyond the oral formulation, UTHR is developing ralinepag DPI (RAL-DPI), an inhaled dry-powder version of ralinepag, in collaboration with MannKind Corporation MNKD. While initially targeting PAH, management sees potential opportunities for RAL-DPI in PH-ILD, IPF and PPF. The company plans to file an investigational new drug application later this year. Management expects approval for nebulized Tyvaso in IPF and oral ralinepag in PAH in 2027. United Therapeutics is progressing well with the development of its organ manufacturing business. Last month, the company acquired Thymmune Therapeutics, a Cambridge-based, privately held biotech company developing regenerative thymic cell therapies. The acquisition reinforces United Therapeutics’ commitment to advancing regenerative medicine and expanding the availability and long-term success of organ transplantation. The acquisition added THY-100, Thymmune’s lead investigational therapy, to the company’s pipeline. United Therapeutics Corporation price-consensus-eps-surprise-chart | United Therapeutics Corporation Quote United Therapeutics currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech sector are Harmony Biosciences HRMY and Liquidia Corporation LQDA, each currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here. Over the past 60 days, earnings per share estimates for Harmony Biosciences have increased from $3.20 to $3.33 for 2026. Over the same period, estimates for earnings per share increased from $3.64 to $3.87 for 2027. HRMY shares have risen 2.2% year to date. Harmony Biosciences missed on earnings in three of the trailing four quarters and beat in the remaining one, delivering an average negative surprise of 13.97%. Over the past 60 days, estimates for Liquidia’s 2026 earnings per share have increased to $3.02 from $2.97. Over the same period, EPS estimates for 2027 have risen to $5.31 from $4.81. LQDA shares have gained 158.4% year to date. Liquidia’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 54.40%. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report United Therapeutics Corporation (UTHR) : Free Stock Analysis Report MannKind Corporation (MNKD) : Free Stock Analysis Report Liquidia Corporation (LQDA) : Free Stock Analysis Report Harmony Biosciences Holdings, Inc. (HRMY) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

This article first appeared on GuruFocus. Release Date: August 05, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. United Therapeutics Corp (NASDAQ:UTHR) reported exceptional clinical results from its advanced outcomes study, demonstrating ralinepag's potential as a major new oral therapy for PAH. The company submitted two important new drug applications to the FDA: an sNDA for nebulized Tyvaso in IPF and an NDA for ralinepag in PAH, with potential approvals expected in 2027. Tyvaso DPI showed growth and exited the quarter with record levels of starts, referrals, tolls, and commercial patients, indicating strong underlying momentum. The company has a deep and differentiated organ pipeline, including xenotransplantation programs (Kidney Expand, UKidney, and UKHeart studies), which could create significant long-term growth opportunities. United Therapeutics Corp (NASDAQ:UTHR) expanded its sales force by roughly double in early July, which is expected to increase physician engagement and support stronger commercial performance in the second half of the year. United Therapeutics Corp (NASDAQ:UTHR) generated approximately $783 million in total revenue in Q2 2026, which was essentially flat with the first quarter and below company expectations. Nebulized Tyvaso revenue remained pressured by increased competition within the inhaled prostacyclin category, as patients and providers evaluate more treatment options. The company did not reaffirm any prior revenue growth expectations for 2026, signaling uncertainty about near-term financial performance. The path to achieving the previously projected $4 billion revenue run rate by the end of 2027 has narrowed, requiring contributions from anticipated IPF and ralinepag launches. The launch of Tyvaso in IPF will initially be limited to the nebulized formulation, as regulatory approval for DPI and SMI devices in that indication is still pending further FDA engagement. Warning! GuruFocus has detected 3 Warning Sign with UTHR. Is UTHR fairly valued? Test your thesis with our free DCF calculator. Q: How much of the recent momentum lost to increased competition in the inhaled prostacyclin space can be recaptured with new offerings like Roliopag in PAH or the SMI device in PH-ILD? A: Michael Benkowitz, President and COO, stated that Roliopag represents a multi-billion dollar opportunity, supported by the strong data from the advanced outcome studies. He noted that the initial feedback from physicians is very positive, and the combination of once-daily oral dosing with the demonstrated clinical benefit positions the company for an exciting launch. Similarly, the SMI device is viewed as a differentiated way to deliver therapies across all indications, with tolerability benefits that should be well-received by physicians and patients, further differentiating the company from competitors. Q: Can you provide expectations for the launch ramp-up for new products, including nebulized Tyvaso in IPF, Roliopag, and the SMI device? A: Michael Benkowitz, President and COO, said the company will share more detailed launch trajectory information in the second half of 2026 or early 2027. He emphasized that both opportunities are expected to be multi-billion dollar opportunities, but the speed of the ramp will depend on regulatory factors, such as whether priority review is granted. The company is currently working on commercial preparation and will provide updates as more information on regulatory filing status becomes available. Q: Is the consensus estimate of $147 million in back-half Tyvaso revenue achievable given the competitive dynamics, or should expectations be adjusted? A: Michael Benkowitz, President and COO, declined to reaffirm or update specific revenue guidance, reiterating that the company expects the second half of 2026 to be stronger than the first half. He did not provide further specifics on quarterly revenue targets, leaving the guidance at a high level. Q: Coming out of ATS, how do you expect Tyvaso to be positioned in the IPF treatment landscape, and what will be the main driver of future prescribing? A: Michael Benkowitz, President and COO, clarified that at launch, only nebulized Tyvaso will be available for IPF, as the company is still in discussions with the FDA regarding DPI and SMI approvals. Feedback from key opinion leaders indicates excitement about the data, and they expect IPF treatment to move toward a polytherapy approach, similar to PAH. Most physicians plan to use Tyvaso in combination with other products, making the sequencing less important than the overall shift to combination therapy. Q: What type of data would be needed to get DPI and SMI approved for IPFwould bridging data suffice, or would additional efficacy data be required? A: Pat Poisson, EVP of Strategic Development, and Dr. Lee Peterson, EVP of Product Development, explained that the company is engaged with the FDA to determine the requirements. They have ideas for bridging studies and a program to present to the agency, similar to past approaches. The specifics are yet to be determined, but the same bridging strategy applies to both SMI and DPI. Q: Can you discuss the sales force expansion ahead of the IPF launch, and how much of it is already deployed to support current indications? A: Michael Benkowitz, President and COO, confirmed that the company has essentially completed its plan to roughly double the sales force, with representatives entering the field by July 1st. Since Roliopag and IPF are not yet approved, these reps are currently focused on increasing reach and frequency for approved indications like PAH and PH-ILD. The expansion is strategically aimed at going deeper into the community where IPF patients reside, which differs from the more academic-center focus of PAH. Q: How big is the IPF revenue opportunity at peak, and how does the impressive uptake of a competitor impact your launch strategy? Also, can you share baseline characteristics of PPF patients enrolled in the trial? A: Michael Benkowitz, President and COO, said the company will provide more details on peak potential and launch trajectory later in 2026 or early 2027. He acknowledged the competitor's strong launch and noted that the company is factoring in historical launches like Ofev and Esbriet into its planning. Dr. Lee Peterson added that the PPF study enrollment is ahead of schedule and nearly complete, with baseline characteristics of the patient population to be presented at upcoming conferences. Q: Can you share the filing date for the IPF sNDA, when we might hear about acceptance, and whether priority review is a possibility? A: Dr. Lee Peterson, EVP of Product Development, confirmed the sNDA was submitted in late June. The company expects to learn shortly whether it will receive priority review, which would result in a 6-month review period, versus a standard 10-month period. No specific date was provided for the acceptance announcement. For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Interested in United Therapeutics Corporation? Here are five stocks we like better. Second-quarter revenue was approximately $783 million, essentially flat sequentially, as competition pressured nebulized TYVASO sales. Management expects stronger performance in the second half of 2026 but did not update its full-year revenue outlook. TYVASO DPI showed strong momentum, with record patient starts, referrals and commercial patients, while United Therapeutics roughly doubled its sales force to support PAH and PH-ILD growth and potential future IPF and ralinepag launches. The company advanced its respiratory pipeline by filing applications for nebulized TYVASO in IPF and ralinepag in PAH, with potential approvals in 2027. Its xenotransplantation programs also progressed, including planned kidney and heart studies and new organ-manufacturing facilities. These 3 Stocks Lowered Their Share Counts Drastically in Q1 United Therapeutics (NASDAQ:UTHR) reported second-quarter 2026 revenue of approximately $783 million, essentially flat from the first quarter, as competitive pressure affected sales of its nebulized TYVASO therapy. Company executives said they expect stronger performance in the second half of the year but did not reaffirm or update previous 2026 revenue-growth expectations. TYVASO revenue totaled $453 million during the quarter. President and Chief Operating Officer Michael Benkowitz said nebulized TYVASO faced increasing competition in the inhaled prostacyclin category, while TYVASO DPI continued to grow. He said the company exited the quarter with record levels of patient starts, referrals, total patients and commercial patients for the DPI formulation. → SpaceX’s First Earnings Report Could Decide Whether Shorts or Bulls Have Control The Top 3 Stock Picks at the World’s Greatest Hedge Fund “We exited the second quarter with considerably more momentum than the reported revenue line alone would suggest,” Benkowitz said. United Therapeutics expects second-half 2026 performance to exceed first-half results, supported by expanded commercial coverage and patient-demand metrics. United Therapeutics roughly doubled its sales force and deployed the expanded team in early July, according to Benkowitz. The representatives are currently promoting approved therapies in pulmonary arterial hypertension, or PAH, and pulmonary hypertension associated with interstitial lung disease, or PH-ILD. → 3 Drone Stocks That Should Soar After the Summer Slump Liquidia: Court victory the awakening of an industry giant? The larger field organization is intended to support potential future launches in idiopathic pulmonary fibrosis, or IPF, and PAH. Benkowitz said the IPF patient population is more concentrated in community settings than the company’s current customer base, requiring broader outreach beyond academic medical centers. Management said the company still sees a path to its previously discussed $4 billion annualized revenue run rate by the end of 2027, although Benkowitz said that path has narrowed. He added that anticipated contributions from potential IPF and ralinepag launches could help the company reach or exceed that level. United Therapeutics expects second-half 2026 revenue performance to be stronger than the first half. The company did not provide updated 2026 revenue guidance or confirm analysts’ specific TYVASO revenue estimates. Management said TYVASO DPI demand indicators, including starts and referrals, reached record levels exiting the quarter. → The Bitcoin Comeback May Already Be Underway—2 ETFs for Exposure Chairperson and Chief Executive Officer Martine Rothblatt said the company submitted two major regulatory applications following positive clinical results: a supplemental new drug application, or sNDA, for nebulized TYVASO in IPF and a new drug application, or NDA, for ralinepag in PAH. Rothblatt characterized the TETON-1 IPF results as exceeding the TETON-2 findings reported last September. She also cited results from the ADVANCE OUTCOMES study of ralinepag, which management believes support the oral therapy’s potential in PAH. Leigh Peterson, executive vice president of product development and xenotransplantation, said the IPF sNDA was submitted in late June. The company expects to learn shortly whether the FDA will grant priority review. A priority review would carry a six-month review period, compared with 10 months under a standard review, Peterson said. The company expects potential approvals in 2027 for nebulized TYVASO in IPF, ralinepag in PAH, and its treprostinil small-molecule inhalation device, or SMI, in PAH and PH-ILD. United Therapeutics also plans to file an investigational new drug application for ralinepag DPI and an NDA for treprostinil SMI later this year. Benkowitz said management views ralinepag as a potential once-daily oral prostacyclin option and a multibillion-dollar opportunity. He said physicians’ initial feedback on the ADVANCE OUTCOMES data has been positive. The company also expects SMI to offer a differentiated method of administering inhaled therapies, potentially including tolerability benefits. If TYVASO receives approval in IPF next year, the initial launch would involve the nebulized formulation only. Benkowitz said United Therapeutics remains in discussions with the FDA regarding the data needed to support IPF indications for TYVASO DPI and SMI. Peterson said the company has proposed bridging strategies for both DPI and SMI and is seeking FDA feedback. Management did not specify whether additional efficacy studies would be required. In discussions with physicians following the TETON results, Benkowitz said clinicians have expressed interest in using TYVASO alongside other IPF medicines. He said providers expect IPF treatment to move toward a polytherapy approach, similar to treatment patterns in PAH, although sequencing would depend on individual patients. United Therapeutics also said enrollment in its TETON PPF trial is nearly complete and ahead of schedule. The company expects to disclose baseline characteristics of enrolled progressive pulmonary fibrosis patients at future conferences and anticipates a Phase 3 readout in the second half of 2027. Beyond its pulmonary portfolio, United Therapeutics continues to advance organ-transplantation programs. Rothblatt said the UKidney EXPAND study’s initial six-patient cohort is expected to be completed later this year, while the company anticipates initiating the UThymoKidney EXTEND registration-enabling study. Following FDA clearance, the company is also preparing to begin the EXPRESS-UHeart study. The company expects to complete construction by year-end on two additional commercial-scale designated pathogen-free facilities in Minnesota and Texas. Rothblatt also noted the recent acquisition of Thymmune Therapeutics, which added a thymus-based regenerative medicine platform to United Therapeutics’ organ-alternative strategy. United Therapeutics Corporation (NASDAQ: UTHR) is a biotechnology company dedicated to the development and commercialization of unique products to address life-threatening illnesses. The company's primary focus has been on pulmonary arterial hypertension (PAH), where it has launched several therapies designed to improve functional capacity and quality of life for patients. Its marketed products include continuous infusion treprostinil (Remodulin), inhaled treprostinil (Tyvaso), oral treprostinil (Orenitram) and tadalafil (Adcirca), each tailored to different modes of administration and patient needs. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "United Therapeutics Q2 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for August 2026.

SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C., August 05, 2026--(BUSINESS WIRE)--United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, today announced its financial results for the quarter ended June 30, 2026. Total revenues in the second quarter of 2026 decreased by two percent year-over-year to $783.3 million, compared to $798.6 million in the second quarter of 2025. "We just submitted what we believe are two of the most important NDAs in rare pulmonary disease history: ralinepag tablets in PAH and Nebulized Tyvaso in IPF," said Martine Rothblatt, Ph.D., Chairperson and Chief Executive Officer of United Therapeutics. "We believe that these submissions, accompanied by our planned filings later this year – an IND application for ralinepag DPI and an NDA for treprostinil SMI – may herald an opportunity for a quantum increase in our growth by the end of the decade. By next year, we expect potential approvals for Nebulized Tyvaso in IPF and ralinepag tablets in PAH, two potentially transformative, multi-billion-dollar catalysts that could significantly enhance our growth profile. We expect Tyvaso DPI will then follow Nebulized Tyvaso’s wake into IPF and then PPF. Moreover, our organ manufacturing pipeline continues to advance rapidly with clinical trials ongoing or being planned for liver, kidney, heart, and lung products, and the launch later this year of two xeno-organ production facilities in Minnesota and Texas." "Tyvaso DPI exited the second quarter at record levels of starts, referrals, commercial patients, and total patients, reflecting strong underlying demand," said Michael Benkowitz, President and Chief Operating Officer of United Therapeutics. "Supported by our competitively differentiated device, deep clinical experience, and significant remaining opportunity in PH-ILD, we are confident in our ability to extend our leadership position in the inhaled prostacyclin class." Second Quarter 2026 Financial Results Key financial highlights include (dollars in millions, except per share data): Revenues The table below presents the components of total revenues (dollars in millions): Total Tyvaso revenues decreased by four percent to $452.6 million in the second quarter of 2026, compared to $469.6 million in the second quarter of 2025, driven by a decrease in Nebulized Tyvaso revenues, partially offset by growth in Tyvaso DPI revenues. The growth in Tyvaso DPI revenues resulted primarily from an increase in quantities sold of $6.9 million and a price increase of $9.4 million, partially offset by higher gross-to-net deductions. The decrease in Nebulized Tyvaso revenues resulted primarily from a decrease in U.S. quantities sold of $37.6 million, partially offset by a price increase. The decrease in Remodulin revenues resulted primarily from a decrease in U.S. quantities sold of $12.3 million, partially offset by an increase in international revenues. We believe the availability of competitive therapies negatively impacted sales of Nebulized Tyvaso, Tyvaso DPI, and Remodulin for the three and six months ended June 30, 2026. The table below presents the breakdown of total revenues between the United States and rest-of-world (ROW) (in millions): Expenses Cost of sales. The table below summarizes cost of sales by major category (dollars in millions): Cost of sales, excluding share-based compensation. The increase in cost of sales for the three months ended June 30, 2026, as compared to the same period in 2025, was primarily due to an increase in inventory reserve expense. Of this increased amount, $7.5 million related to estimated losses under a commercial supply agreement intended to provide sufficient Tyvaso DPI inventory to meet the needs of our patients. Research and development expense. The table below summarizes the nature of research and development expense by major expense category (dollars in millions): Research and development, excluding share-based compensation. The increase in research and development expense for the three months ended June 30, 2026, as compared to the same period in 2025, was primarily due to: (1) an increase in expenditures related to cardiopulmonary treatment projects; and (2) an increase in the fair value of our contingent consideration obligations for manufactured organ and organ alternative projects obtained through acquisition. Selling, general, and administrative expense. The table below summarizes selling, general, and administrative expense by major category (dollars in millions): General and administrative, excluding impairment of PP&E and share-based compensation. The increase in general and administrative expense for the three months ended June 30, 2026, as compared to the same period in 2025, was primarily due to: (1) an increase in personnel expense due to growth in headcount; and (2) an increase in consulting expenses, partially offset by a decrease in legal expenses related to litigation matters. Impairment of PP&E. The decrease in impairment of PP&E during the three months ended June 30, 2026, as compared to the same period in 2025, was primarily due to the impairment charge to write down the carrying value of certain PP&E in 2025, which did not recur in 2026. Sales and marketing, excluding share-based compensation. The increase in sales and marketing expense for the three months ended June 30, 2026, as compared to the same period in 2025, was primarily due to an increase in personnel expense due to growth in headcount. Share-based compensation expense. The table below summarizes share-based compensation expense by major category (dollars in millions): Interest income. Interest income was $31.5 million and $51.3 million for the three months ended June 30, 2026 and 2025, respectively. The decrease in interest income was primarily due to a decrease in marketable investments due to the sale of securities to fund our two accelerated share repurchase agreements in March 2026 (the 2026 ASR agreements). Other income (expense), net. Other income (expense), net for the three months ended June 30, 2026 and 2025 was $13.3 million in income and $0.1 million in expense, respectively. The increase in other income was primarily due to net unrealized gains on equity securities. Income tax expense. Income tax expense for the three months ended June 30, 2026 and 2025 was $39.7 million and $98.9 million, respectively. Our effective income tax rate (ETR) for the three months ended June 30, 2026 and 2025 was 11 percent and 24 percent, respectively. Our ETR for the three months ended June 30, 2026 decreased compared to our ETR for the three months ended June 30, 2025, primarily due to increased excess tax benefits from share-based compensation. Share repurchase. In March 2026, our Board of Directors approved a share repurchase program authorizing up to $2.0 billion in aggregate repurchases of our common stock, which expires on March 9, 2027. In March 2026, we also entered into the 2026 ASR agreements with Citibank, N.A. to repurchase approximately $1.5 billion of our common stock. During the three months ended June 30, 2026, we received an additional 378,936 shares of our common stock upon the first to settle of the 2026 ASR agreements. The other 2026 ASR agreement settled in August 2026, and we received an additional 215,948 shares of our common stock upon final settlement. In total, we repurchased 2,759,343 shares of our common stock under the 2026 ASR agreements, of which 2,543,395 were held as treasury stock in our consolidated balance sheets as of June 30, 2026. As of June 30, 2026, $500 million remained available under the share repurchase program authorized by our Board for purchases through March 9, 2027. Webcast We will host a webcast to discuss our second quarter 2026 financial results on Wednesday, August 5, 2026, at 9:00 a.m. Eastern Time. The webcast can be accessed live via our website at https://ir.unither.com/events-and-presentations. An investor presentation is available now, and after the webcast a replay of the webcast will also be available, at the same location on our website. About United Therapeutics Founded by CEO Martine Rothblatt to discover a cure for her daughter's life-threatening rare disease, pulmonary arterial hypertension, United Therapeutics transforms the treatment of rare diseases and pioneers alternatives to expand the supply of transplantable organs. From our innovative therapies to our groundbreaking manufactured organs, we are bold and unconventional. We move quickly from scientific theory to practical technologies that can save lives. As a public benefit corporation, even our legal structure reflects our commitments. We serve patients, act with integrity, create long-term shareholder value, and operate with sustainable practices that protect the future we are working to build. Forward-Looking Statements Statements included in this press release 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 statements related to: our research and development and regulatory plans, including the potential outcome of our NDA and sNDA seeking approval for ralinepag tablets for PAH and Nebulized Tyvaso for IPF, respectively, our plans to submit by the end of this year an IND for ralinepag DPI and an NDA for treprostinil SMI, our plans to develop Tyvaso DPI for IPF and PPF; the potential for us to achieve a quantum increase in our growth by the end of the decade; our expectation that ralinepag tablets and Nebulized Tyvaso for IPF represent multi-billion-dollar catalysts that could significantly enhance our growth profile; our organ manufacturing pipeline, including our planned clinical trials and our plan to launch new xeno-organ facilities later this year; our expectation that our competitively differentiated device, deep clinical experience, and significant remaining opportunity in PH-ILD will enable us to extend our leadership position in the inhaled prostacyclin class; and our goals of expanding the supply of transplantable organs, developing practical technologies that can save lives, creating long-term shareholder value, and operating with sustainable practices. These forward-looking statements are subject to certain risks and uncertainties, such as those described in our periodic reports filed with the Securities and Exchange Commission, that could cause actual results to differ materially from anticipated results. Consequently, such forward-looking statements are qualified by the cautionary statements, cautionary language and risk factors set forth in our periodic reports and documents filed with the Securities and Exchange Commission, including our most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K. We claim the protection of the safe harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. We are providing this information as of August 5, 2026, and assume no obligation to update or revise the information contained in this press release whether as a result of new information, future events, or any other reason. ORENITRAM, REMODULIN, REMUNITY, REMUNITYPRO, TYVASO, TYVASO DPI, and UNITUXIN are registered trademarks of United Therapeutics Corporation. ADCIRCA is a registered trademark of Eli Lilly and Company. Abbreviations: 1. NDA = new drug application. 2. PAH = pulmonary arterial hypertension. 3. IPF = idiopathic pulmonary fibrosis. 4. IND = investigational new drug. 5. DPI = dry powder inhaler. 6. SMI = soft mist inhaler. 7. PPF = progressive pulmonary fibrosis. View source version on businesswire.com: https://www.businesswire.com/news/home/20260805108888/en/ Contacts For Further Information Contact: Investor Inquirieshttps://ir.unither.com/contact-ir Media [email protected]

United Therapeutics (UTHR) reported $783.3 million in revenue for the quarter ended June 2026, representing a year-over-year decline of 1.9%. EPS of $7.27 for the same period compares to $6.41 a year ago. The reported revenue represents a surprise of -2.51% over the Zacks Consensus Estimate of $803.48 million. With the consensus EPS estimate being $6.82, the EPS surprise was +6.6%. While investors closely watch year-over-year changes in headline numbers -- revenue and earnings -- and how they compare to Wall Street expectations to determine their next course of action, some key metrics always provide a better insight into a company's underlying performance. Since these metrics play a crucial role in driving the top- and bottom-line numbers, comparing them with the year-ago numbers and what analysts estimated about them helps investors better project a stock's price performance. Here is how United Therapeutics performed in the just reported quarter in terms of the metrics most widely monitored and projected by Wall Street analysts: Revenues- Unituxin: $65.2 million versus $56.5 million estimated by four analysts on average. Compared to the year-ago quarter, this number represents a +11.6% change. Revenues- Adcirca: $6.7 million compared to the $5.71 million average estimate based on four analysts. The reported number represents a change of +3.1% year over year. Revenues- Tyvaso: $452.6 million versus $468.89 million estimated by four analysts on average. Compared to the year-ago quarter, this number represents a -3.6% change. Revenues- Remodulin: $126.3 million compared to the $130.03 million average estimate based on four analysts. The reported number represents a change of -6.2% year over year. Revenues- Orenitram: $125.7 million versus $133.32 million estimated by four analysts on average. Compared to the year-ago quarter, this number represents a +1.5% change. Revenues- Other products: $6.8 million versus the two-analyst average estimate of $5.4 million. The reported number represents a year-over-year change of +23.6%. Revenues- Nebulized Tyvaso: $126 million versus $135.18 million estimated by two analysts on average. Compared to the year-ago quarter, this number represents a -18.4% change. Revenues- Tyvaso DPI: $326.6 million compared to the $336.25 million average estimate based on two analysts. The reported number represents a change of +3.6% year over year. View all Key Company Metrics for United Therapeutics here>>> Shares of United Therapeutics have returned -8% over the past month versus the Zacks S&P 500 composite's +3.5% change. The stock currently has a Zacks Rank #2 (Buy), indicating that it could outperform the broader market in the near term. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report United Therapeutics Corporation (UTHR) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Management attributes flat sequential revenue to increased competition within the inhaled prostacyclin category, which has pressured nebulized Tyvaso performance. The company doubled its sales force in July 2026 to increase engagement frequency and reach deeper into community-based physicians ahead of major launches. Record levels of patient starts, referrals, and total commercial patients at the end of Q2 are cited as indicators of underlying momentum not yet reflected in revenue. Strategic positioning is shifting toward 'super-prostacyclin' ralinepag and nebulized Tyvaso for IPF, which management views as multibillion-dollar opportunities. The acquisition of Thymmune Therapeutics serves as a strategic extension of the organ alternative mission, adding a thymus-based regenerative medicine platform. Operating efficiency is maintained through a disciplined 'budget algorithm' to fund high-stakes clinical readouts and organ manufacturing infrastructure. Management expects the second half of 2026 to outperform the first half, driven by the expanded sales force and record patient metrics exiting Q2. The $4 billion revenue run rate target for 2027 remains achievable but has 'narrowed,' now requiring contributions from anticipated IPF and ralinepag launches. Potential 2027 approvals are expected for nebulized Tyvaso in IPF, ralinepag in PAH, and the SMI device in PAH and PH-ILD. The TETON-PPF trial is nearing full enrollment, with a Phase III readout projected for the second half of 2027 to target an opportunity double the size of IPF. Construction of two commercial-scale organ manufacturing facilities in Minnesota and Texas is scheduled for completion by the end of 2026. The sNDA for nebulized Tyvaso in IPF and the NDA for ralinepag in PAH were submitted in late June 2026, with priority review status pending. Management explicitly declined to reaffirm or update prior 2026 revenue growth expectations despite expressing confidence in second-half momentum. A 'Lock The F In' (LTFI) internal culture is emphasized to ensure current commercial execution is not sacrificed for future pipeline potential. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. Management believes ralinepag's once-daily oral profile and clinical outcomes from ADVANCE OUTCOMES will differentiate it from current competitors. The SMI device is expected to offer tolerability benefits that could help recapture momentum across all inhaled indications. Physician feedback suggests IPF is moving toward a polytherapy approach similar to PAH, where Tyvaso would be used in combination with other products. The vast majority of doctors surveyed indicated they would use Tyvaso regardless of whether it is sequenced as first or second-line therapy. The 2027 IPF launch will initially be limited to the nebulized form; the company is currently negotiating bridging strategies with the FDA for DPI and SMI versions. Management is proposing a strategy to the FDA that may involve new patient starts or specific bridging data rather than full new efficacy trials. The expanded sales force is currently detailing approved PAH and PH-ILD indications to build relationships before the potential 2027 launches. The expansion was specifically designed to reach IPF patients who reside more frequently in community settings rather than academic centers.