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United Therapeutics (UTHR) Q4 Earnings & Sales Beat Estimates
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United Therapeutics‘ (UTHR - Free Report) fourth-quarter 2023 earnings of $4.36 per share beat the Zacks Consensus Estimate of $3.92. Earnings rose 63% year over year on the back of higher product sales.
Revenues in the reported quarter were $614.7 million, beating the Zacks Consensus Estimate of $562 million. Revenues rose 25% year over year, driven by Tyvaso sales.
Quarter in Detail
United Therapeutics markets four products for pulmonary arterial hypertension (PAH) — Remodulin, Tyvaso, Adcirca and Orenitram. It also markets Unituxin for treating pediatric patients with high-risk neuroblastoma.
Tyvaso sales totaled $350.6 million, up 45% year over year. Tyvaso revenues contributed $213.7 million to sales from the Tyvaso dry powder inhalation (DPI) formulation, which was launched in 2022 and $136.9 million in sales from nebulized Tyvaso. Sales of Tyvaso DPI rose 132% in the quarter, driven by higher volumes and continued growth in utilization by patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD). Sales of nebulized Tyvaso declined 9% due to lower volumes following patient switch to Tyvaso DPI.
Tyvaso DPI is a drug-device product that offers some benefits over the nebulized Tyvaso and is approved for PAH and PH-ILD indications. Nebulized Tyvaso is also approved for PAH and PH-ILD.
Tyvaso sales beat the Zacks Consensus Estimate of $321 million and our model estimate of $309 million.
Shares of United Therapeutics were up 2.3% on Feb 21, likely due to the better-than-expected Tyvaso sales. The stock has lost 0.3% year to date against the industry’s 1.0% rise.
Image Source: Zacks Investment Research
Remodulin (including Remunity Pump) sales fell 6% year over year to $115.1 million, while Orenitram sales rose 11% year over year to $84.1 million.
Unituxin sales rose 48% year over year to $54.2 million. Adcirca sales were $6.8 million, down 35% year over year.
Research and development expenses were $151.4 million in the quarter, up 61% year over year. Selling, general and administrative expenses were down 19% to $132.2 million in the quarter.
Full-Year Results
United Therapeutics reported total revenues of $2.33 billion, up 20% year over year. The upside was driven by growth in sales of Tyvaso and Orenitram.
The company’s reported earnings for 2023 were $19.81 per share, up 32% from the year-ago period.
Pipeline Update
United Therapeutics’ key phase III pipeline programs include TETON 1 and TETON 2 phase III studies of nebulized Tyvaso in patients with idiopathic pulmonary fibrosis and ADVANCE OUTCOMES studies on oral ralinepag for PAH.
Last year in October, United Therapeutics announced that the first patient had been enrolled in the 52-week phase III TETON PPF study of nebulized Tyvaso in patients with another type of pulmonary fibrosis called progressive pulmonary fibrosis.
Sues FDA Over NDA Filing Process
In a separate press release, United Therapeutics announced that it has filed a lawsuit against the FDA, alleging that the latter made a mistake in allowing Liquidia Corporation (LQDA - Free Report) to amend a pending new drug application (NDA) submission. The amendment, filed by Liquidia last year in September, sought to add PH-ILD indication in their NDA seeking approval for Yutrepia in PAH.
Per UTHR, such amendments are not allowed and should only be approved by way of a separate NDA. Moreover, Liquidia seeks approval for Yutrepia in PH-ILD based on the INCREASE study conducted by United Therapeutics. If the company is successful in its litigation against the FDA, Liquidia's drug approval in PH-ILD indication might be delayed for up to 30 months.
The above litigation is part of an ongoing lawsuit between United Therapeutics and Liquidia over Tyvaso’s patents. Yutrepia is a DPI formulation of treprostinil developed by Liquidia Technologies, which was granted tentative approval by the FDA in November 2021. A final approval is pending until the litigations related to Tyvaso patents is resolved.
United Therapeutics currently carries a Zacks Rank #2 (Buy). Some other top-ranked stocks in the overall healthcare sector include Adicet Bio (ACET - Free Report) and Puma Biotechnology (PBYI - Free Report) . While Puma Biotechnology sports a Zacks Rank #1 (Strong Buy) at present, Adicet carries a Zacks Rank #2. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Puma Biotechnology’s 2023 earnings per share have risen from 72 cents to 73 cents. Meanwhile, during the same period, earnings per share estimates for 2024 have improved from 64 cents to 71 cents. Year to date, shares of PBYI have rallied 50.4%.
Earnings of Puma Biotechnology beat estimates in three of the last four quarters while missing the same on one occasion. Puma delivered a four-quarter average earnings surprise of 76.55%.
In the past 60 days, estimates for Adicet Bio’s 2024 loss per share have improved from $2.11 to $1.81. Year to date, shares of ACET have surged 42.3%.
Earnings of Adicet Bio beat estimates in two of the trailing four quarters while missing the mark on the other two occasions. On average, Adicet came up with a four-quarter negative earnings surprise of 8.36%.
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United Therapeutics (UTHR) Q4 Earnings & Sales Beat Estimates
United Therapeutics‘ (UTHR - Free Report) fourth-quarter 2023 earnings of $4.36 per share beat the Zacks Consensus Estimate of $3.92. Earnings rose 63% year over year on the back of higher product sales.
Revenues in the reported quarter were $614.7 million, beating the Zacks Consensus Estimate of $562 million. Revenues rose 25% year over year, driven by Tyvaso sales.
Quarter in Detail
United Therapeutics markets four products for pulmonary arterial hypertension (PAH) — Remodulin, Tyvaso, Adcirca and Orenitram. It also markets Unituxin for treating pediatric patients with high-risk neuroblastoma.
Tyvaso sales totaled $350.6 million, up 45% year over year. Tyvaso revenues contributed $213.7 million to sales from the Tyvaso dry powder inhalation (DPI) formulation, which was launched in 2022 and $136.9 million in sales from nebulized Tyvaso. Sales of Tyvaso DPI rose 132% in the quarter, driven by higher volumes and continued growth in utilization by patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD). Sales of nebulized Tyvaso declined 9% due to lower volumes following patient switch to Tyvaso DPI.
Tyvaso DPI is a drug-device product that offers some benefits over the nebulized Tyvaso and is approved for PAH and PH-ILD indications. Nebulized Tyvaso is also approved for PAH and PH-ILD.
Tyvaso sales beat the Zacks Consensus Estimate of $321 million and our model estimate of $309 million.
Shares of United Therapeutics were up 2.3% on Feb 21, likely due to the better-than-expected Tyvaso sales. The stock has lost 0.3% year to date against the industry’s 1.0% rise.
Image Source: Zacks Investment Research
Remodulin (including Remunity Pump) sales fell 6% year over year to $115.1 million, while Orenitram sales rose 11% year over year to $84.1 million.
Unituxin sales rose 48% year over year to $54.2 million. Adcirca sales were $6.8 million, down 35% year over year.
Research and development expenses were $151.4 million in the quarter, up 61% year over year. Selling, general and administrative expenses were down 19% to $132.2 million in the quarter.
Full-Year Results
United Therapeutics reported total revenues of $2.33 billion, up 20% year over year. The upside was driven by growth in sales of Tyvaso and Orenitram.
The company’s reported earnings for 2023 were $19.81 per share, up 32% from the year-ago period.
Pipeline Update
United Therapeutics’ key phase III pipeline programs include TETON 1 and TETON 2 phase III studies of nebulized Tyvaso in patients with idiopathic pulmonary fibrosis and ADVANCE OUTCOMES studies on oral ralinepag for PAH.
Last year in October, United Therapeutics announced that the first patient had been enrolled in the 52-week phase III TETON PPF study of nebulized Tyvaso in patients with another type of pulmonary fibrosis called progressive pulmonary fibrosis.
Sues FDA Over NDA Filing Process
In a separate press release, United Therapeutics announced that it has filed a lawsuit against the FDA, alleging that the latter made a mistake in allowing Liquidia Corporation (LQDA - Free Report) to amend a pending new drug application (NDA) submission. The amendment, filed by Liquidia last year in September, sought to add PH-ILD indication in their NDA seeking approval for Yutrepia in PAH.
Per UTHR, such amendments are not allowed and should only be approved by way of a separate NDA. Moreover, Liquidia seeks approval for Yutrepia in PH-ILD based on the INCREASE study conducted by United Therapeutics. If the company is successful in its litigation against the FDA, Liquidia's drug approval in PH-ILD indication might be delayed for up to 30 months.
The above litigation is part of an ongoing lawsuit between United Therapeutics and Liquidia over Tyvaso’s patents. Yutrepia is a DPI formulation of treprostinil developed by Liquidia Technologies, which was granted tentative approval by the FDA in November 2021. A final approval is pending until the litigations related to Tyvaso patents is resolved.
United Therapeutics Corporation Price
United Therapeutics Corporation price | United Therapeutics Corporation Quote
Zacks Rank & Other Key Picks
United Therapeutics currently carries a Zacks Rank #2 (Buy). Some other top-ranked stocks in the overall healthcare sector include Adicet Bio (ACET - Free Report) and Puma Biotechnology (PBYI - Free Report) . While Puma Biotechnology sports a Zacks Rank #1 (Strong Buy) at present, Adicet carries a Zacks Rank #2. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Puma Biotechnology’s 2023 earnings per share have risen from 72 cents to 73 cents. Meanwhile, during the same period, earnings per share estimates for 2024 have improved from 64 cents to 71 cents. Year to date, shares of PBYI have rallied 50.4%.
Earnings of Puma Biotechnology beat estimates in three of the last four quarters while missing the same on one occasion. Puma delivered a four-quarter average earnings surprise of 76.55%.
In the past 60 days, estimates for Adicet Bio’s 2024 loss per share have improved from $2.11 to $1.81. Year to date, shares of ACET have surged 42.3%.
Earnings of Adicet Bio beat estimates in two of the trailing four quarters while missing the mark on the other two occasions. On average, Adicet came up with a four-quarter negative earnings surprise of 8.36%.