United Therapeutics (UTHR) and Liquidia (LQDA): Trading Places

Initial Disclosure: Funds managed by Bleecker Street are short United Therapeutics (UTHR) and long Liquidia Corp (LQDA). Please see the full disclosure at the end of this report.

UTHR is a $13 billion commercial-stage pharmaceutical company. The majority of its revenues come from a single product, Tyvaso. UTHR had been trying to keep a Tyvaso competitor called Yutrepia off the market for 5 years through patent suits, but its legal remedies appear to be coming to an end.

• Yutrepia launched in June. We conducted a survey in July that showed Yutrepia is making swift inroads into new patient prescriptions and Tyvaso’s existing patient base alike, capturing an estimated 5% market share in less than two months.

• We surveyed 18 Tyvaso prescribers in July, 11 of whom are top prescribers of the drug, and they were not only enthusiastic about Yutrepia, but had already prescribed Yutrepia to 5% of their addressable patient population within two months of launch.

• Yutrepia looks primed to take significant business away from UTHR: physicians estimated that Yutrepia would seize 50% market share on average, with several stating they would likely make Yutrepia their preferred prescribing choice because of its better tolerability and the ability to administer higher doses without discontinuation of treatment.

• Per doctors we spoke to, UTHR’s revenue erosion will be most pronounced in the fast-growing PH-ILD indication, where Yutrepia’s improved side effect profile is most helpful for patients.

• We estimate that a continued Yutrepia rollout at the pace observed in our survey will cause UTHR’s Tyvaso sales to decline ~11% by 2026 vs. 2024. We estimate this will drive a ~22% drop in 2026 EPS.

• UTHR’s pipeline appears too meager to be able to reignite sales growth in the face of stiff competition, including through a prospective Tyvaso indication that two doctors described to us as difficult to justify. Remaining UTHR patent challenges to Yutrepia seem to us to be insubstantial.

• Other next-generation therapies with superior dosing, including one from Insmed and another from LQDA, have designs on Tyvaso’s market and, we believe, will continue to take share from Tyvaso.

• We think the incumbent here is overexposed, and the challenger is significantly underappreciated. We are short UTHR and long LQDA.

UTHR Appears Poised for a Rude Awakening

Savvy UTHR competitor LQDA, whose CEO is the former co-CEO of UTHR, has launched Yutrepia to compete with UTHR’s pulmonary hypertension drug Tyvaso. That rollout appears to be running well ahead of expectations, per our conversations with top Tyvaso prescribers, many of whom are already introducing their patients to the drug. Several of those physicians opined to us that Yutrepia is a superior formulation and is a welcome solution for patients who find it difficult to tolerate Tyvaso or to escalate doses to an appropriate level.

UTHR has been highly litigious in protecting its profit pool from incoming competition. Over the course of the last five years, UTHR has filed numerous lawsuits and patent infringement cases against Liquidia in an effort to block the Yutrepia launch, with arguments ranging from patent infringement to irreparable harm. UTHR went so far as to allege that delaying Yutrepia would be in the interest of the public good, another move we believe the company attempted in order to extend UTHR’s monopoly status. A series of courtroom defeats led LQDA to receive FDA approval finally this May. For the first time since Tyvaso’s launch in 2009, there is a directly competing product. 

This month, we surveyed 18 Tyvaso prescribers, 11 of whom are top prescribers of the drug. Among the doctors surveyed, Yutrepia had already taken 5% share of Tyvaso prescriptions. We estimate that at this growth rate, Yutrepia will dent UTHR’s 2026 Tyvaso revenues by ~11%. Meanwhile, the legal cloud over LQDA appears to be on the cusp of clearing up, setting the stage for significant undisturbed revenue growth from Yutrepia.

An Introduction to Tyvaso and the Conditions it Treats

UTHR’s flagship product, Tyvaso, is an inhaled form of the drug treprostinil. In 2009, the FDA approved Tyvaso for the treatment of pulmonary arterial hypertension (PAH). Roughly 50,000-100,000 Americans suffer from PAH. There are numerous PAH treatments available, and assuming a patient’s condition is mild to moderate, they are often treated with a combination of cheaper oral medications before they might be considered for inhaled treprostinil.

In 2021, Tyvaso was also approved to treat pulmonary hypertension associated with interstitial lung disease (PH-ILD). PH-ILD has a similar population size to PAH, but unlike PAH, there were no other approved PH-ILD treatments, granting Tyvaso an effective monopoly in the category.

And in 2022, the Tyvaso dry powder inhaler (DPI) was approved for PAH and PH-ILD. The DPI formulation is a more convenient form factor than the original nebulizer, leading to higher compliance.

Tyvaso DPI grew to become most of Tyvaso revenue, and Tyvaso in turn became the majority of UTHR’s revenue, with PH-ILD appearing to account for most of the script growth:

As of Q1 2025, annualized Tyvaso revenues were $1.9 billion.

Yutrepia Appears to Offer Material Treatment Advantages to Tyvaso

Yutrepia is also a formulation of treprostinil, but in a powder that appears to be better-tolerated by patients, based on clinical studies and our interviews with top Tyvaso prescribers. Liquidia’s PRINT technology for manufacturing treprostinil means Yutrepia particles are roughly half the size of Tyvaso particles. This emphasis on particle uniformity appears to improve tolerability and limit discontinuations due to adverse events like persistent cough.

Patients in Yutrepia trials were able to titrate up to a dose that is multiples of the maximum dose in Tyvaso DPI’s trials. Further, the ongoing Yutrepia trial in PH-ILD, ASCENT, has shown no discontinuations at 8 weeks, while an observational study of Tyvaso DPI in PH-ILD patients reported discontinuation rates of 50%+, especially among patients who had never had a Tyvaso treatment. Patients in this Tyvaso DPI study stopped treatment as soon as 4 days in.

When we asked pulmonologists about tolerability and patient feedback, they consistently referenced Yutrepia’s superior side effect profile, its formulation, and device properties as reasons for adoption.

“At this point in time, Yutrepia may be more beneficial or more efficacious for patients than Tyvaso DPI. We may argue among ourselves about Tyvaso nebulized versus Yutrepia, but at least if we're comparing apple to apples, Tyvaso DPI versus Yutrepia DPI, I believe that Yutrepia is probably more efficacious because it's more tolerable and because it's more deliverable at higher concentration to the lungs as compared to Tyvaso.”

- Northwell Health Pulmonologist

We heard repeatedly that Yutrepia was proving itself out the gate with success in harder-to-treat patients who had to discontinue Tyvaso:

“So the ones that I changed from Tyvaso to Yutrepia were mainly due to side effects that they were still having with the Tyvaso DPI and not improving. They were not able to escalate the dose, so we ended up changing. Another one we were able to escalate, but was unhappy with some of the side effects that were still present. And the PAH patients, since Yutrepia seems to be well tolerated from a side-effect standpoint, I just decided to see if it's for those PAH patients as well… In terms of the early experience, it has been good. With Yutrepia, you know, we've been able to escalate therapy on those cases and there seem to be minimal side effects.”

- National Jewish Health Pulmonologist

“What I have done more recently since the beginning of July, actually, is those people I can't get them to titrate in a nebulized form or they are on DPI but they can't get to a target dose -- I have switched a few of them to Yutrepia. And so far, I haven't heard back from them that they are having significant worsening of cough or significant side effects. I'm excited about that as a treatment option for those patients who I cannot get targeted on the optimum dose with Tyvaso… I had several patients have to stop treatment altogether, and they have been waiting for Yutrepia to be approved in order to get some kind of treatment for their disease.”

- Northwell Health Pulmonologist

One physician cited a case in which Yutrepia helped an ILD patient go straight to a high-dose DPI treatment quickly:
“To date, I have one patient, who is actually a PH-ILD patient, who wanted to go directly to a DPI. Didn't want to do the nebulizer thing, wanted to wait until Yutrepia became available, started on it, and he is just blasting through the dose titration. He's really tolerating increasing the dosing without blinking, and without complaints of cough, airway irritation, or anything else.”

- Penn Presbyterian Pulmonologist

While a pulmonologist cited Yutrepia as the favorable, low flow option:

“At the end I mean I tried both devices myself placebo, and they're completely different – Yutrepia is low flow and low resistance so it's easy to get in there rapidly… and the other one you have to put a little bit more effort, with the Tyvaso DPI, because it’s high resistance and high flow.”

- Cleveland Clinic Pulmonologist

Tyvaso Prescribers We Surveyed Reported 5% Yutrepia share in July

This month, we surveyed 18 Tyvaso prescribers, 11 of whom are top prescribers of the drug, on their prescribing activity, and Yutrepia has been winning market share with both de novo scripts and switches of existing scripts.

In fact, new prescriptions were split roughly evenly between Tyvaso switches and prostacyclin-naive patients, suggesting Yutrepia adoption is broad-based:

Physicians we spoke to were very welcoming of the new treatment and were willing to allow it to supplant Tyvaso in their practice in many cases:

“I will be definitely prescribing more Yutrepia than Tyvaso. So, what I'm doing since the beginning of July, that's when I started to prescribe it, I'm exclusively now prescribing Yutrepia…”

- Northwell Health Pulmonologist

“My personal take based on the mechanism of action of these drugs is if I have to rank them, I would say Yutrepia is probably going to be better tolerated for patients… So, Yutrepia is going to do better when you compare and contrast to Tyvaso, that's for sure.”

- Northwestern Medicine Pulmonologist

“I mean, it's pretty early, to be honest, but I do think that it is useful especially with the formulation, and especially with patients with really decreased inspiratory effort, where they may not be getting the full effect of Tyvaso because they just can't inhale it deeply enough.”

- Rush Hospital Pulmonologist

Our Base Case Estimate Is UTHR Will Lose ~11% of Tyvaso Revenue by 2026

We estimate that UTHR currently has ~8,800 Tyvaso patients as of Q1 2025 between the PAH and PH-ILD populations. Based on the results of our July survey, we estimate in our base case that Yutrepia will capture ~30% of existing patients in 2026, resulting in a 11% loss of Tyvaso revenues, a 3% total revenue decline, and an accompanying 22% decline in UTHR EPS from 2024 to 2026. 

In our bear case, which assumes that Yutrepia share capture accelerates, we estimate that Yutrepia will take ~45% of the market in 2026, causing a 28% decline in Tyvaso revenues, a 12% decline in total UTHR revenue, and a 37% fall in UTHR EPS from 2024 to 2026:

UTHR management, for its part, asserted to investors in mid-Q2 2025 that Yutrepia will only take a 5% share of the market due to “undifferentiation across the board”:

However, per our survey results, not only is LQDA already at an estimated ~5% market share only two months after launch: several top prescribers we spoke to expected a 50 / 50% market share split in their practices longer-term, with some doctors forecasting an 80 / 20% split in favor of Yutrepia going forward, particularly in ILD.

“So I can see the, at least at our center, and in terms of my patients, I could see more of my inhaled population now by the end of the year, maybe like 10% of them being mostly Yutrepia, that would include both new starts and transitions, and then I think that number's going to increase. I think that number's going to just keep going up as time goes by.”

- National Jewish Health Pulmonologist

“Just judging by the data, I think people will probably use it more. And, you know, on the medium horizon, yeah, I think a 50-50 prescription split makes sense.”

- Rush Hospital Pulmonologist

“So I think there's, there's some good opportunity for Yutrepia in the market to do well, because right now, what other option do you have?”

- Baylor College of Medicine Pulmonologist

“It depends on how Yutrepia delivers its research and how aggressive it gets and how many points it tries to tackle… so if it gets aggressive, then I think it could become a 50 / 50 share split.”

- Baylor College of Medicine Pulmonologist

“I think, probably 50-50 prescription split on the PAH group, and then on the ILD group, I would probably, say probably 80-20 in favor of Yutrepia, I think is a good number, actually, on the PAH-ILD side.”

- National Jewish Health Pulmonologist

UTHR’s Legal Challenges to Yutrepia Seem Close to Exhausted

UTHR and LQDA have been locked in a legal battle over Yutrepia since 2020. That year, Yutrepia filed an NDA for Yutrepia, prompting a lawsuit from United Therapeutics. The two have been in a morass of patent litigation ever since, with United Therapeutics delaying Yutrepia’s commercialization even as Liquidia invalidated or was found not to infringe on key UTHR patents. Yutrepia eventually received marketing approval in May 2025, after an exclusivity period for Tyvaso DPI expired.

UTHR still has two patent suits directed at Liquidia and Yutrepia, but we believe they are unlikely to succeed: one concerns Patent No. 11,826,327 (the ‘327 patent), and one just filed regarding Patent No. 11,357,782 (the ‘782 patent). The ‘327 patent was filed in 2021 and covers improving exercise capacity in PH-ILD patients using treprostinil. The ‘782 patent was filed the same year and covers a specific manner and speed of administering inhaled treprostinil. UTHR was not able to obtain an injunction stopping Yutrepia’s rollout in the ‘327 suit, which would have required UTHR to show that Liquidia’s patent challenge in the case lacked obvious merit. The ‘782 suit, on the other hand, was filed this May regarding a patent added to the FDA Orange Book listing for Tyvaso DPI only this April and expiring in 2027. We believe these are last-gasp attempts by UTHR to put LQDA on the back foot and will not succeed.

UTHR’s Pipeline Appears Insufficient to Plug a Yutrepia-Sized Hole

Furthermore, the UTHR pipeline seems to us to lack the strength to reverse forthcoming Tyvaso revenue losses to Yutrepia, which may explain the acrimony over the Yutrepia launch.

UTHR touts the revenue potential of an additional Tyvaso indication being pursued in idiopathic pulmonary fibrosis (IPF), with sell-side analysts viewing it as a key source of medium-term revenue growth since Tyvaso is a well known drug, but we believe the likelihood of a blockbuster IPF commercialization is not high. IPF is a form of ILD that counts about 100,000 sufferers in the United States, and UTHR stands to receive a 7-year orphan drug exclusivity period in IPF if Tyvaso is approved for the disease. However, physicians we spoke to had a mixed view of the likelihood of success in IPF.

According to two Tyvaso prescribers we interviewed, IPF itself is unlikely to respond to Tyvaso treatment, making it less useful than approved treatments like antifibrotic medications. A significant minority of IPF patients already have pulmonary hypertension, with prevalence estimates varying depending on the study but clustering conservatively around 25-40%. Since UTHR’s Phase 3 TETON studies in IPF are screening patients using CT scans, not the right-heart catheterization used to detect pulmonary hypertension, it is possible that Tyvaso is treating only pulmonary hypertension caused by IPF, not the IPF itself. As one prescriber stated:

“We have a center of excellence studying interstitial lung disease. IPF is a condition that is a scarring process. The lung scarring isn’t a vascular phenomenon - it's likely autoimmune or genetics-driven, and the prostacyclin agonists like Tyvaso don’t really interact with the disease, they only address some of the vascular problems that stem from it. So I don’t think this is going to be a transformational agent at all in IPF and I’m willing to put money on it… One in three IPF patients have some sort of pulmonary hypertension.”

- Corewell Health Pulmonologist

Moreover, even if Tyvaso is eventually approved for IPF but Yutrepia is physician-preferred, some doctors will likely prescribe Yutrepia off label, irrespective of any orphan drug exclusivity. Per a top prescriber we spoke to, the compound is the same, therefore so is the application:

“So as long as it’s [Yutrepia’s] in the market and it continues to deliver on what it says it does, I don't think that Tyvaso will be the only player in the IPF market… I don't really think that it's going to work out the way United Therapeutics thinks it will.”

- Baylor Medicine Pulmonologist

Tyvaso Competition Will Only Intensify, Further Denting UTHR Revenues

We believe emerging inhaled therapies by Liquidia, Insmed, and others will only continue to eat at Tyvaso market share over the medium term.

These include Insmed’s treprostinil palmitil (TPIP) powder, which reported promising Phase 2 trial results in June and only requires once-a-day administration, rather than the 4 daily doses required for Tyvaso and the 3-5 per day needed for Yutrepia. Physicians we spoke to were very excited at the prospect of having a once-daily option for patient compliance, expressing cautious optimism.

Liquidia, too, is investigating a next-generation treprostinil suspension called L606 that would require only twice-daily administration and plans to commence a pivotal trial by the end of 2025. Despite L606 requiring a nebulizer for drug administration, twice a day use would likely preclude patients from having to carry around the device and would offer a material improvement over the status quo, according to a Tyvaso prescriber.

UTHR, for its part, remained in the preclinical stage for its once-daily Tyvaso equivalent as of April 2025.

UTHR Management Is Selling Eye-Popping Amounts of Stock

In the last 12 months, as UTHR’s legal challenges to the Yutrepia launch all but completely fell away, UTHR executives and board members have been dumping stock. Insider took home $179M in net proceeds, with the company’s General Counsel Accounting for $50M of that total:

We think the writing is on the wall for UTHR’s Tyvaso, and we are long LQDA.

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