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United Therapeutics (UTHR) Q4 Earnings & Sales Miss, Stock Down
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United Therapeutics (UTHR - Free Report) reported earnings of $2.35 per share for fourth-quarter 2021, widely missing the Zacks Consensus Estimate of $3.77 per share. Earnings declined 7.3% 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 $3.51 per share, up 6% year over year driven by higher revenues.
United Therapeutics markets four products for pulmonary arterial hypertension (“PAH”) — Remodulin, Tyvaso, Adcirca and Orenitram — and Unituxin for high-risk neuroblastoma.
Revenues for the reported quarter were $415.2 million, which missed the Zacks Consensus Estimate of $419.97 million. However, revenues rose 7.9% year over year driven by double-digit revenue growth of Tyvaso and Unituxin, partially offset by lower sales of the other three drugs.
Quarter in Detail
Tyvaso sales totaled $166.5 million, up 26% 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 2021. The company expects around 6,000 U.S. patients on Tyvaso therapy by the end of 2022.
Remodulin sales were $118.3 million, down 8% year over year. Unituxin’s sales of $50 million surged 68% year over year.
Adcirca sales were $8.1 million, down 63% 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 2008. Eli Lilly markets tadalafil as Cialis for erectile dysfunction. United Therapeutics’ Adcirca/Eli Lilly’s Cialis lost exclusivity in 2018 and generic versions are available.
Orenitram sales amounted to $72.3 million in the reported quarter, down 2% year over year.
Research and development (R&D) expenses were $82.9 million in the quarter, down 34% year over year. Selling, general and administrative expenses declined 19% to $127.9 million in the quarter due to higher legal and consulting costs.
Full-Year Results
United Therapeutics reported revenues of $1.69 billion, up 14% year over year. Sales were driven by growth in sales of Tyvaso, Orenitram and Unituxin. The company’s reported earnings for 2021 were $10.06 per share, down 12.8% from the year-ago period.
Pipeline Update
United Therapeutics is working on expanded indications for Orenitram and Tyvaso. Several 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.
United Therapeutics is seeking approval for its drug-device combination therapy, Tyvaso Dry Powder Inhaler (“DPI”), developed in partnership with MannKind Corporation (MNKD - Free Report) . Tyvaso DPI incorporates the dry powder formulation technology and Dreamboat inhalation device technology used in one of MannKind’s FDA-approved drugs. Per an existing agreement, MannKind is responsible for manufacturing and supplying Tyvaso DPI to United Therapeutics.
Along with the earnings release, United Therapeutics announced that the FDA has extended the review period of the new drug application (“NDA”) for Tyvaso DPI, which is now expected to be completed in May 2022. The NDA sought approval of Tyvaso DPI to treat PAH and PH-ILD.
The extension of the review period for Tyvaso DPI NDA along with lower-than-expected fourth-quarter results is likely to have dampened investors’ sentiments, which drove United Therapeutics’ shares lower by 13.2% on Thursday. In the past year, the stock has gained 0.3% against the industry’s decrease of 32.2%.
Image Source: Zacks Investment Research
In October, the FDA issued a complete response letter to United Therapeutics’ NDA for Tyvaso DPI. The company addressed the issues raised in the CRL and resubmitted the NDA in December, following which the FDA issued an action date for February 2022. However, earlier this month, the FDA requested additional information related to the pulmonary safety of Tyvaso DPI. The company’s response to the additional information requested was considered a major amendment to the NDA, which led to the extension of the review period to May. The company believes that Tyvaso DPI is expected to be less time-consuming to administer, and more mobile and convenient that can lead to higher acceptance by patients, likely driving sales higher.
United Therapeutics Corporation Price, Consensus and EPS Surprise
Image: Bigstock
United Therapeutics (UTHR) Q4 Earnings & Sales Miss, Stock Down
United Therapeutics (UTHR - Free Report) reported earnings of $2.35 per share for fourth-quarter 2021, widely missing the Zacks Consensus Estimate of $3.77 per share. Earnings declined 7.3% 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 $3.51 per share, up 6% year over year driven by higher revenues.
United Therapeutics markets four products for pulmonary arterial hypertension (“PAH”) — Remodulin, Tyvaso, Adcirca and Orenitram — and Unituxin for high-risk neuroblastoma.
Revenues for the reported quarter were $415.2 million, which missed the Zacks Consensus Estimate of $419.97 million. However, revenues rose 7.9% year over year driven by double-digit revenue growth of Tyvaso and Unituxin, partially offset by lower sales of the other three drugs.
Quarter in Detail
Tyvaso sales totaled $166.5 million, up 26% 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 2021. The company expects around 6,000 U.S. patients on Tyvaso therapy by the end of 2022.
Remodulin sales were $118.3 million, down 8% year over year. Unituxin’s sales of $50 million surged 68% year over year.
Adcirca sales were $8.1 million, down 63% 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 2008. Eli Lilly markets tadalafil as Cialis for erectile dysfunction. United Therapeutics’ Adcirca/Eli Lilly’s Cialis lost exclusivity in 2018 and generic versions are available.
Orenitram sales amounted to $72.3 million in the reported quarter, down 2% year over year.
Research and development (R&D) expenses were $82.9 million in the quarter, down 34% year over year. Selling, general and administrative expenses declined 19% to $127.9 million in the quarter due to higher legal and consulting costs.
Full-Year Results
United Therapeutics reported revenues of $1.69 billion, up 14% year over year. Sales were driven by growth in sales of Tyvaso, Orenitram and Unituxin. The company’s reported earnings for 2021 were $10.06 per share, down 12.8% from the year-ago period.
Pipeline Update
United Therapeutics is working on expanded indications for Orenitram and Tyvaso. Several 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.
United Therapeutics is seeking approval for its drug-device combination therapy, Tyvaso Dry Powder Inhaler (“DPI”), developed in partnership with MannKind Corporation (MNKD - Free Report) . Tyvaso DPI incorporates the dry powder formulation technology and Dreamboat inhalation device technology used in one of MannKind’s FDA-approved drugs. Per an existing agreement, MannKind is responsible for manufacturing and supplying Tyvaso DPI to United Therapeutics.
Along with the earnings release, United Therapeutics announced that the FDA has extended the review period of the new drug application (“NDA”) for Tyvaso DPI, which is now expected to be completed in May 2022. The NDA sought approval of Tyvaso DPI to treat PAH and PH-ILD.
The extension of the review period for Tyvaso DPI NDA along with lower-than-expected fourth-quarter results is likely to have dampened investors’ sentiments, which drove United Therapeutics’ shares lower by 13.2% on Thursday. In the past year, the stock has gained 0.3% against the industry’s decrease of 32.2%.
Image Source: Zacks Investment Research
In October, the FDA issued a complete response letter to United Therapeutics’ NDA for Tyvaso DPI. The company addressed the issues raised in the CRL and resubmitted the NDA in December, following which the FDA issued an action date for February 2022. However, earlier this month, the FDA requested additional information related to the pulmonary safety of Tyvaso DPI. The company’s response to the additional information requested was considered a major amendment to the NDA, which led to the extension of the review period to May. The company believes that Tyvaso DPI is expected to be less time-consuming to administer, and more mobile and convenient that can lead to higher acceptance by patients, likely driving sales higher.
United Therapeutics Corporation Price, Consensus and EPS Surprise
United Therapeutics Corporation price-consensus-eps-surprise-chart | United Therapeutics Corporation Quote
Zacks Rank & A Key Pick
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 Collegium Pharmaceutical (COLL - Free Report) , sporting a Zacks Rank of 1.
Collegium’searnings per share estimates have moved north from $3.66 to $5.43 for 2022 in the past 30 days. COLL has gained 14.5% so far this year.
Collegium delivered a negative earnings surprise of 57.55%, on average, in the last four quarters.