United Therapeutics ( UTHR Quick Quote UTHR - Free Report) reported earnings of $5.03 per share for first-quarter 2022, beating the Zacks Consensus Estimate of $2.96 per share. Earnings were 63 cents in the year-ago quarter
United Therapeutics markets four products for pulmonary arterial hypertension (PAH) — Remodulin, Tyvaso, Adcirca, and Orenitram, all of which use PAH drug substance, treprostinil.
Revenues for the reported quarter were $461.9 million, which beat the Zacks Consensus Estimate of $411.0 million. Revenues rose 22% year over year driven by double-digit revenue growth of Tyvaso, Orenitram and Unituxin. United Therapeutics expects to have 25,000 patients on its therapies by 2025.
The stock was up 3.7% on Wednesday after the earnings announcement. This year so far, the stock has declined 13.8% compared with the
industry’s decrease of 19.6%. Image Source: Zacks Investment Research Quarter in Detail
Tyvaso sales totaled $172.0 million, up 40% year over year, gaining from higher volumes as a result of patient growth, following the label expansion approval for the PH-ILD indication in April 2021.
The company expects around 6,000 U.S. patients on Tyvaso therapy by the end of 2022. United Therapeutics is approximately halfway toward the goal, with about 4,400 active patients on Tyvaso therapy as of the end of the first quarter.
Orenitram sales amounted to $82.8 million in the reported quarter, up 14% year over year due to higher volumes (driven by the FREEDOM-EV label expansion) and price increases.
Remodulin sales were $131.7 million, up 1% year over year as higher international revenues were offset by lower U.S. sales. Remodulin saw the highest level of referrals in the first quarter of 2022 since 2014 despite generic competition. Unituxin’s sales of $55.6 million rose 27% year over year, driven by the launch in Japan and price increase.
Adcirca sales were $9.8 million, up 2% year over year.
Please note that United Therapeutics bought exclusive rights to commercialize Adcirca (tadalafil) for PAH in the United States from
Eli Lilly ( LLY Quick Quote 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 (R&D) expenses were $69.0 million in the quarter compared with $303.7 million in the year-ago quarter due to higher impairment and special charges recorded in the year-ago quarter. Selling, general and administrative expenses declined 33% to $79.0 million in the quarter.
United Therapeutics is working on expanded indications for Orenitram and Tyvaso. Seven phase III studies are ongoing across various forms of pulmonary hypertension and pulmonary fibrosis.
The FDA approved a label expansion of Tyvaso to include patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD) in April 2021. The company is seeking approval for its drug-device combination therapy, Tyvaso Dry Powder Inhaler (DPI) as a potential treatment for PAH and PH-ILD. In October 2021, United therapeutics received a complete response letter (CRL) from the FDA for Tyvaso DPI and resubmitted the NDA in December 2021. In February 2022, the FDA asked for additional information related to Tyvaso DPI’s pulmonary safety. The company responded to the request and a decision from the FDA is expected later this month.
The drug-device product 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. If approved, Tyvaso DPI has the potential to expand Tyvaso’s use in both Group 1 and Group 3 pulmonary hypertension
Key phase III programs include Tyvaso in WHO Group 3 pulmonary hypertension (PH) patients who have COPD (PERFECT study), Tyvaso in patients with various forms of chronic fibrosing interstitial lung disease (TETON studies) and oral ralinepag (PAH — ADVANCE CAPACITY and ADVANCE OUTCOMES studies). The first TETON study in patients with idiopathic pulmonary fibrosis (IPF) is currently enrolling patients. The second phase III study of Tyvaso in IPF patients, TETON 2 will be conducted in the United States and is expected to commence soon. Enrollment is ongoing in the PERFECT, ADVANCE CAPACITY and ADVANCE OUTCOMES studies.
United Therapeutics currently carries a Zacks Rank #3 (Hold). You can see
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