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United Therapeutics UTHR reported earnings of $3.62 per share for third-quarter 2021, beating the Zacks Consensus Estimate of $3.37 per share. However, earnings declined 6% year over year.
The abovementioned earnings include the impact of share-based compensation expenses, impairment charges and other items. Excluding these items, adjusted earnings were $4.16 per share, up 7% year over year driven by higher revenues.
United Therapeutics markets four products for pulmonary arterial hypertension (PAH) — Remodulin, Tyvaso, Adcirca, and Orenitram.
Revenues for the reported quarter were $444.7 million, which beat the Zacks Consensus Estimate of $416.0 million. Revenues rose 17% year over year driven by double-digit revenue growth of Tyvaso, Orenitram and Unituxin.
The stock was up 5.7% on Wednesday after the earnings were announced. This year so far, the stock has risen 34% against the industry’s decrease of 14.2%.
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Quarter in Detail
Orenitram sales amounted to $85.2 million in the reported quarter, up 14% year over year due to higher volumes resulting from patient growth, following the FREEDOM-EV label expansion. A price increase also pulled up Orenitram sales in the third quarter. The company saw the highest number of new patients on Orenitram at the end of the third quarter.
Tyvaso sales totaled $164.2 million, up 27% year over year, gaining from higher volumes as a result of patient growth, following the label expansion approval for the PAH associated with interstitial lung disease (PH-ILD) indication in April based on data from the phase III INCREASE study. With the approval for this indication, the company expects around 6,000 U.S. patients on Tyvaso therapy by the end of 2022. Approximately 4,000 U.S. patients were on Tyvaso therapy at the end of the third quarter.
Remodulin sales were $125.4 million, up 1% year over year. Unituxin’s (for the treatment of pediatric patients with high-risk neuroblastoma) sales of $55.3 million surged 47% year over year driven by volume growth and price increase.
Adcirca sales were $14.6 million, up 6% 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 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 $79.5 million in the quarter, up 15% year over year. Selling, general and administrative expenses rose 65% to $109.1 million in the quarter due to higher legal and consulting costs.
United Therapeutics is working on expanded indications for Orenitram and Tyvaso. Six phase III studies are ongoing across various forms of pulmonary hypertension and pulmonary fibrosis.
The 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 enrolled its first patients in June 2021.
Last month, the FDA issued a complete response letter to United Therapeutics’ new drug application (“NDA”) for its drug-device combination therapy, Tyvaso Dry Powder Inhaler or Tyvaso DPI. The NDA sought approval of Tyvaso DPI to treat PAH and PH-ILD. Per the CRL, the FDA identified a deficiency related to an open inspection issue at a third-party facility that performs analytical testing of the treprostinil drug substance. This prevented the FDA from approving the NDA in its present form. Following the CRL, the company anticipates that the FDA’s query regarding the deficiency can be resolved quickly and it can obtain approval for Tyvaso DPI in the United States by the summer of 2022. The drug-device product offers some benefits over 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. The NDA filing was based on data from the BREEZE study. United Therapeutics has developed Tyvaso DPI in collaboration with MannKind Corporation MNKD
United Therapeutics currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
A better-ranked drugmaker is Xencor (XNCR), sporting a Zacks Rank of 1. Estimates for the 2021 bottom line have narrowed from a loss of 75 cents per share to 33 cents per share, while that for 2022 have improved from a loss of $3.14 per share to a loss of $2.92 per share over the past 30 days.
United Therapeutics Corporation Price, Consensus and EPS Surprise
United Therapeutics Corporation price-consensus-eps-surprise-chart | United Therapeutics Corporation Quote
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