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United Therapeutics (UTHR) Q2 Earnings & Sales Beat, Stock Up
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United Therapeutics (UTHR - Free Report) reported earnings of $3.65 per share for second-quarter 2021, beating the Zacks Consensus Estimate of $2.86 per share. Earnings rose 51% year over year due to higher revenues and lower costs.
The abovementioned earnings include the impact of share-based compensation expenses, impairment charges and other items. Excluding these items, adjusted earnings were $4.09 per share, up 11% year over year.
Revenues for the reported quarter were $446.5 million, which beat the Zacks Consensus Estimate of $379.0 million. Revenues rose 23% year over year driven by revenue growth of all its products.
United Therapeutics markets four products for pulmonary arterial hypertension (PAH) — Remodulin, Tyvaso, Adcirca, and Orenitram.
The stock was up 14.1% on Wednesday after the earnings were announced. This year so far, the stock has risen 35.8% against the industry’s decrease of 10.7%.
Image Source: Zacks Investment Research
Quarter in Detail
Orenitram sales amounted to $76.2 million in the reported quarter, up 1% year over year due to higher volumes resulting from patient growth, following the FREEDOM-EV label expansion
Tyvaso sales totaled $123.8 million, up 29% year over year, gaining from higher volumes as a result of patient growth following the label expansion approval for PAH associated with interstitial lung disease (PH-ILD) indication in April based on data from the phase III INCREASE study. The approval for this indication has made Tyvaso eligible for more than double the patients on therapy.
The company saw the highest level of new prescriptions and patient starts of Tyvaso and Orenitram since their launches in the second quarter. It expects to double the number of patients on Tyvaso therapy by 2022 mainly through the PH-ILD label expansion.
Remodulin sales were $139.8 million, up 17% year over year due to recovery in patient starts from the impact of the pandemic.
Unituxin’s (for the treatment of pediatric patients with high-risk neuroblastoma) sales of $53.1 million surged 83% year over year driven by volume growth.
Adcirca sales were $23.6 million, up 22% 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 - 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 $74.3 million in the quarter, down 17% year over year. Selling, general and administrative expense rose 7% to $112.8 million in the quarter due to higher legal and consulting costs.
Pipeline Update
United Therapeutics is working on expanded indications for Orenitram and Tyvaso.
In January 2021, the BREEZE study met its primary objective of demonstrating safety and tolerability of Tyvaso dry powder inhaler/Tyvaso DPI in PAH patients who transitioned from Tyvaso Inhalation Solution. A new drug application (NDA) seeking approval of Tyvaso DPI for both PAH and PH-ILD indications is under priority review with the FDA with a decision expected in October. The approval of the NDA is subject to an inspection by the FDA of the Tyvaso DPI manufacturing facility in Danbury. The FDA has initiated the inspection. The Danbury facility is operated by United Therapeutics’ partner, MannKind Corporation (MNKD - Free Report)
Other key phase III programs include Tyvaso in PAH 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.
United Therapeutics developed an Implantable System for Remodulin (ISR), an implantable pump for delivering Remodulin intravenously in collaboration with Medtronic (MDT - Free Report) . In June, the companies, announced plans to discontinue the ISR program.
Image: Bigstock
United Therapeutics (UTHR) Q2 Earnings & Sales Beat, Stock Up
United Therapeutics (UTHR - Free Report) reported earnings of $3.65 per share for second-quarter 2021, beating the Zacks Consensus Estimate of $2.86 per share. Earnings rose 51% year over year due to higher revenues and lower costs.
The abovementioned earnings include the impact of share-based compensation expenses, impairment charges and other items. Excluding these items, adjusted earnings were $4.09 per share, up 11% year over year.
Revenues for the reported quarter were $446.5 million, which beat the Zacks Consensus Estimate of $379.0 million. Revenues rose 23% year over year driven by revenue growth of all its products.
United Therapeutics markets four products for pulmonary arterial hypertension (PAH) — Remodulin, Tyvaso, Adcirca, and Orenitram.
The stock was up 14.1% on Wednesday after the earnings were announced. This year so far, the stock has risen 35.8% against the industry’s decrease of 10.7%.
Image Source: Zacks Investment Research
Quarter in Detail
Orenitram sales amounted to $76.2 million in the reported quarter, up 1% year over year due to higher volumes resulting from patient growth, following the FREEDOM-EV label expansion
Tyvaso sales totaled $123.8 million, up 29% year over year, gaining from higher volumes as a result of patient growth following the label expansion approval for PAH associated with interstitial lung disease (PH-ILD) indication in April based on data from the phase III INCREASE study. The approval for this indication has made Tyvaso eligible for more than double the patients on therapy.
The company saw the highest level of new prescriptions and patient starts of Tyvaso and Orenitram since their launches in the second quarter. It expects to double the number of patients on Tyvaso therapy by 2022 mainly through the PH-ILD label expansion.
Remodulin sales were $139.8 million, up 17% year over year due to recovery in patient starts from the impact of the pandemic.
Unituxin’s (for the treatment of pediatric patients with high-risk neuroblastoma) sales of $53.1 million surged 83% year over year driven by volume growth.
Adcirca sales were $23.6 million, up 22% 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 - 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 $74.3 million in the quarter, down 17% year over year. Selling, general and administrative expense rose 7% to $112.8 million in the quarter due to higher legal and consulting costs.
Pipeline Update
United Therapeutics is working on expanded indications for Orenitram and Tyvaso.
In January 2021, the BREEZE study met its primary objective of demonstrating safety and tolerability of Tyvaso dry powder inhaler/Tyvaso DPI in PAH patients who transitioned from Tyvaso Inhalation Solution. A new drug application (NDA) seeking approval of Tyvaso DPI for both PAH and PH-ILD indications is under priority review with the FDA with a decision expected in October. The approval of the NDA is subject to an inspection by the FDA of the Tyvaso DPI manufacturing facility in Danbury. The FDA has initiated the inspection. The Danbury facility is operated by United Therapeutics’ partner, MannKind Corporation (MNKD - Free Report)
Other key phase III programs include Tyvaso in PAH 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.
United Therapeutics developed an Implantable System for Remodulin (ISR), an implantable pump for delivering Remodulin intravenously in collaboration with Medtronic (MDT - Free Report) . In June, the companies, announced plans to discontinue the ISR program.
Zacks Rank
United Therapeutics currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
United Therapeutics Corporation Price and Consensus
United Therapeutics Corporation price-consensus-chart | United Therapeutics Corporation Quote