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United Therapeutics (UTHR) Q3 Earnings & Sales Beat Estimates

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United Therapeutics (UTHR - Free Report) reported third-quarter 2022 adjusted earnings of $4.91 per share, which beat the Zacks Consensus Estimate of $3.57 per share. Earnings rose 44% year over year.

Revenues for the reported quarter were $516.0 million, which beat the Zacks Consensus Estimate of $492.9 million. Revenues rose 16% year over year driven by Tyvaso.

Shares were up 11% in response to the earnings and sales beat. Shares of United Therapeutics have returned 17.3% in the year-to-date period against the industry’s decline of 29.1%.

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Quarter in Detail

United Therapeutics markets five products for pulmonary arterial hypertension (PAH) — Remodulin, Tyvaso, Adcirca, Unituxin and Orenitram, all of which use PAH drug substance, treprostinil.

United Therapeutics has increased its patient (being treated with one of its treprostinil therapies) additions per quarter by about 66%, from around 300 per quarter in 2021 to around 500 per quarter in 2022. It expects to have 25,000 patients on its medicines by 2025 compared with 10,000 at present.

Tyvaso sales totaled $257.7 million, up 57% year over year, gaining from higher volumes due to patient growth, following the label expansion approval for pulmonary hypertension associated with interstitial lung disease (PH-ILD) indication in 2021 as well as the launch of the Tyvaso dry powder inhalation (DPI) formulation in June.

The Tyvaso DPI formulation for PAH and pulmonary hypertension (PH) associated with PH-ILD is a drug-device product, which offers some benefits over the nebulized Tyvaso Inhalation Solution, which is already approved in the United States to treat PAH and PH-ILD. Tyvaso DPI is expected to be less time-consuming to administer and more mobile and convenient than the original Tyvaso version.

United Therapeutics developed the Tyvaso DPI in partnership with MannKind Corporation (MNKD - Free Report) . Per an existing commercial supply agreement, MannKind is responsible for manufacturing and supplying Tyvaso DPI to United Therapeutics.

In 2021, the company set a goal to double the number of Tyvaso patients from 3,000 to around 6,000 by the end of 2022. As of the end of October, it had around 5,600 patients on Tyvaso.

Orenitram sales amounted to $87.5 million in the reported quarter, up 3% year over year.

Remodulin (including Remunity Pump) sales were $114.0 million, down 9% year over year, due to reduced sales in the United States as well as international markets.

In September, United Therapeutics launched a patient-filled version of the Remunity pump and now offers both pre-filled and patient-filled options. The company said the re-launch of the pump is proceeding well and Remunity starts and total patients on Remunity are expected to grow over the balance of 2022.

Unituxin sales reached $46.1 million, down 17% year over year.

Adcirca sales were $10.7 million, down 27% year over year.

Please note that United Therapeutics bought the exclusive rights to commercialize Adcirca (tadalafil) for PAH in the United States from Eli Lilly (LLY - Free Report) in November 2008. Eli Lilly markets tadalafil as Cialis for erectile dysfunction. Adcirca/Cialis lost exclusivity in 2018 and generic versions are available.

Research and development expenses were $66.1 million in the quarter, down 17% year over year. Selling, general and administrative expenses declined 10% to $98.4 million in the quarter due to Tyvaso-related higher branded prescription drug fee expense.

Pipeline Update

United Therapeutics is working on expanded indications for Orenitram and Tyvaso. Multiple phase III studies are ongoing across various forms of PH and pulmonary fibrosis indications.

Key phase III programs include Tyvaso in patients with various forms of chronic fibrosing interstitial lung disease (TETON studies) and oral ralinepag (PAH — ADVANCE CAPACITY and ADVANCE OUTCOMES studies).

United Therapeutics is enrolling patients in the phase III TETON 1 and TETON 2 studies in patients with idiopathic pulmonary fibrosis. While TETON 1 is being conducted at sites located in the United States and Canada, TETON 2, which was initiated in October 2022, is being conducted outside of the United States and Canada. Enrollment is ongoing in the ADVANCE CAPACITY and ADVANCE OUTCOMES studies.

However, the phase III PERFECT study, evaluating Tyvaso in WHO Group 3 PH patients who have chronic obstructive pulmonary disease, was discontinued in September. The study was discontinued based on a recommendation of the study’s independent Data Safety Monitoring Committee, which conducted an efficacy analysis of the study.

Zacks Rank & Key Pick

United Therapeutics currently carries a Zacks Rank #3 (Hold).

A better-ranked stock in the same sector is Assertio (ASRT - Free Report) , carrying a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Assertio’s earnings estimates for 2022 have increased from 40 cents to 51 cents in the past 90 days, while that for 2023 have gone up from 29 cents to 34 cents. Shares of Assertio have risen 21.6% year to date. Earnings of ASRT beat earnings estimates in three of the last four quarters while missing in one. Assertio delivered an earnings surprise of 126.39%, on average.

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