UTHR Stock Overview
United Therapeutics Corporation, a biotechnology company, engages in the development and commercialization of products to address the unmet medical needs of patients with chronic and life-threatening diseases in the United States and internationally.
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United Therapeutics Corporation Competitors
Price History & Performance
|Historical stock prices|
|Current Share Price||US$205.89|
|52 Week High||US$245.48|
|52 Week Low||US$158.38|
|1 Month Change||-4.37%|
|3 Month Change||-13.60%|
|1 Year Change||9.71%|
|3 Year Change||162.75%|
|5 Year Change||67.64%|
|Change since IPO||3,278.71%|
Recent News & Updates
United Therapeutics: Ability To Expand Tyvaso To Large IPF Market
Summary Tyvaso is being explored by United Therapeutics Corporation in the TETON program (two phase 3 studies) which will determine if label expansion for idiopathic pulmonary fibrosis can be achieved. Tyvaso in an ad-hoc analysis in the short 16-week INCREASE study was shown to improve FVC in PH-ILD patients with IPF. It is expected that the global idiopathic pulmonary fibrosis market could reach $5.32 billion by 2028. Ralinepag is being developed as an oral drug option for the treatment of patients with pulmonary arterial hypertension. United Therapeutics Corporation (UTHR) is a great long-term biotech to own. That's because it is already producing revenues with its drug named Tyvaso (treprostinil), which has been approved by the FDA for pulmonary arterial hypertension ((PAH)) and Pulmonary hypertension with interstitial lung disease ((PH-ILD)). Total revenues in the most recent report increased by 5% year over year, which can be improved upon, but still good nonetheless. Where I believe it can improve on sales with Tyvaso is if it can ultimately obtain FDA approval for this drug for the treatment of patients with idiopathic pulmonary fibrosis ((IPF)). It is a large multi billion-dollar market and there are only a few drugs approved for this indication. While these drugs do okay for these patients, they appear to slightly slow the decline of IPF, but not actually target the underlying cause. What United intends to do is advance the TETON program, that is deploying two studies which will look at the potential for Tyvaso to become a possible disease-modifying drug for IPF. While a major undertaking, I believe it could be a huge payoff if it succeeds. It has already initiated one phase 3 study known as TETON 1 and hopes to soon initiate the other phase 3 study TETON 2 soon enough. The point being that it hopes it can expand on the Tyvaso label to include IPF as well. It even has the ability to advance an oral drug known as Ralinepag for the treatment of patients with pulmonary arterial hypertension ((PAH)). There are two phase 3 studies which are being advanced for this indication which are ADVANCED CAPACITY and ADVANCED OUTCOMES. I believe that this already a great long-term biotech to own because it is already generating revenues with the sale of Tyvaso for a few indications. The ability to possibly expand to the IPF market would be huge for the company, its investors and especially patients who desperately need a new treatment option for IPF. Potential Label Expansion Of Tyvaso For The Treatment Of Patients With Idiopathic Pulmonary Fibrosis The main reason why I believe it is important to look at United Therapeutics Corporation all has to do with the ability to expand the label of Tyvaso to treat patients with IPF. Idiopathic pulmonary fibrosis ((IPF)) is a chronic lung disease which progresses rapidly. The main issue is that it causes scar tissue to build up in the lungs, which in turn makes it hard for oxygen to reach the bloodstream in a proper manner. The term "idiopathic" means it is not known what causes the pulmonary fibrosis to occur. Thus, the name idiopathic pulmonary fibrosis. This disease typically effects the older aged population and comes with some horrible symptoms. Such symptoms that can be found with this disease are: Lung cancer Blood clots occurring in the lungs High blood pressure evolving Pneumonia. It is a very large market opportunity to go after, should United Therapeutics succeed in the phase 3 TETON program using Tyvaso. It is expected that the global idiopathic pulmonary fibrosis market could reach $5.32 billion by 2028. This is a large multi-billion dollar market for sure and that's not all. It is a huge unmet medical need, where new treatment options are desperately needed. Why do I state this? That's because the two approved drugs which are now used to treat IPF are OFEV (nintedanib) from Boehringer Ingelheim and Esbriet (pirfenidone) from Genentech subsidiary of Roche (RHHBY, [[RHHBF]]). Both of these drugs have been approved to slow progression of the disease, but there is room for more improvement. Especially, since there are also a lot of side effects with the two currently approved drugs noted above. Why is United Therapeutics advancing Tyvaso for IPF? The first reason I already mentioned briefly in that current treatment options modestly slow the decline (deterioration) of FVC over a period of time. What the hope with Tyvaso is to actually improve FVC. This is not just me stating this, it is what was actually observed in the short 16-week duration of the INCREASE study. Tyvaso was actually shown to improve Forced Vital Capacity ((FVC)) in the 16-weeks treatment period. The PH-ILD patients also had IPF and as such improvements in FVC were noticed in this INCREASE study. This is great for such a short period of time. The second reason why it is a good idea is because of the great safety profile which was observed from this study. Speaking of the short treatment period of 16-weeks, the phase 3 TETON studies are being designed to treat IPF patients over a period of 52 weeks. If FVC was improved in such an analysis in only 16 weeks, then the hope is that a longer treatment period would mean a substantially greater increase in FVC with a longer treatment period. This is not guaranteed to occur, but if it does happen, then it would be a huge competitive advantage over the other two already regulatory approved drugs OFEV and ESBRIET. It was a post-hoc analysis which is why there should be some caution here, but still the ability to see an improvement in FVC is huge, considering that the two currently approved drugs only serve to slow decline in FVC instead. Having said all that, the first pivotal TETON 1 study of Tyvaso inhalation solution for IPF patients was initiated back in June of 2021. The main thing to note is that this is a U.S. study. United Therapeutics is in the process of launching a second phase 3 study known as TETON 2 coming up. It will be similar to TETON 1, but a huge difference is that it will be conducted outside of the United States. Ralinepag Could Offer Huge Improvement For Pulmonary Arterial Hypertension Patients Even though Tyvaso was approved for the treatment of patients with pulmonary hypertension ((PH)) and pulmonary arterial hypertension ((PAH)), United Therapeutics is advancing an oral drug for PAH. Pfizer (PFE) completed its acquisition of Arena Pharmaceuticals for $6.7 billion back in March of 2022. However, before such an acquisition took place, United Therapeutics bought rights to Ralinepag for an upfront payment of $800 million to Arena at that time. Thus, the reason why United now has rights to advance this drug for PAH. Ralinepag is a once daily oral receptor agonist drug which is currently being explored in two phase 3 studies. These two phase 3 studies are ADVANCE CAPACITY and ADVANCE OUTCOMES. In terms of the ADVANCED OUTCOMES study, it is a randomized, placebo-controlled, double-blind study which is evaluating the use of oral Ralinepag in patients with PAH. The other late-stage study, known as ADVANCE OUTCOMES, is a study being done to determine if Ralinepag can have a huge impact on exercise capacity for patients with PAH. Why the need to advance Ralinepag for PAH? There are a few reasons actually. The first reason is the ability to give patients an oral drug option for starters. The second reason is because in nonclinical trials and proof of concept phase 2, Ralinepag demonstrated superior and improved pharmacology over UPTRAVI (selexipag) in PAH. UPTRAVI is marketed by Johnson & Johnson (JNJ) and was approved for the treatment of patients with PAH to delay disease progression and reduce risk of hospitalization. These two ongoing phase 3 studies will ultimately determine how well Ralinepag does in treating patients with PAH. Financials According to the 10-Q SEC Filing, United Therapeutics had $3.8 billion in cash as of June 30, 2022. It generated total revenues of $466.9 million in Q2 of 2022 which was a 5% year over year increase compared to the same quarter in the year prior. It added a good number of patients on Tyvaso, about 500 during the quarter to be specific. Not only that, but it also had other advancements as well during the same time period. It obtained FDA approval of Tyvaso DPI for PAH and Pulmonary hypertension with interstitial lung disease ((PH-ILD)). What DPI stands for is "dry inhalation powder" which is the first treatment of its type for both of these indications. It offers a more convenient portable option for these patients. That's because the inhaler is so small it fits in the palm of a patient's hand.
|UTHR||US Biotechs||US Market|
Return vs Industry: UTHR exceeded the US Biotechs industry which returned -30.6% over the past year.
Return vs Market: UTHR exceeded the US Market which returned -23.7% over the past year.
|UTHR Average Weekly Movement||3.3%|
|Biotechs Industry Average Movement||11.0%|
|Market Average Movement||6.9%|
|10% most volatile stocks in US Market||15.7%|
|10% least volatile stocks in US Market||2.8%|
Stable Share Price: UTHR is less volatile than 75% of US stocks over the past 3 months, typically moving +/- 3% a week.
Volatility Over Time: UTHR's weekly volatility (3%) has been stable over the past year.
About the Company
United Therapeutics Corporation, a biotechnology company, engages in the development and commercialization of products to address the unmet medical needs of patients with chronic and life-threatening diseases in the United States and internationally. Its commercial therapies include Remodulin to treat patients with pulmonary arterial hypertension (PAH) to diminish symptoms associated with exercise; Tyvaso, an inhaled formulation of prostacyclin analogue treprostinil to enhance the exercise ability in PAH patients and pulmonary hypertension associated with interstitial lung disease (PH-ILD); Orenitram, a tablet dosage form of treprostinil to enhance the exercise capacity in PAH patients; Unituxin, a monoclonal antibody for treating high-risk neuroblastoma; and Adcirca, an oral PDE-5 inhibitor to enhance the exercise ability in PAH patients. The company also engages in developing Tyvaso DPI, a dry powder inhalation form of Tyvaso; Remunity Pump, a small, lightweight, durable pump and separate controller; RemoPro and Ralinepag for the treatment of PAH; Aurora-GT, a gene therapy product to rebuild the blood vessels in the lungs; and Tyvaso PERFECT and TETON studies, which are the studies of Tyvaso in patients with World Health Organization (WHO) Group 3 pulmonary hypertension associated with chronic obstructive pulmonary disease (PH-COPD).
United Therapeutics Corporation Fundamentals Summary
|UTHR fundamental statistics|
Is UTHR overvalued?See Fair Value and valuation analysis
Earnings & Revenue
|UTHR income statement (TTM)|
|Cost of Revenue||US$117.90m|
Last Reported Earnings
Jun 30, 2022
Next Earnings Date
|Earnings per share (EPS)||13.86|
|Net Profit Margin||35.27%|
How did UTHR perform over the long term?See historical performance and comparison