United Therapeutics ( UTHR Quick Quote UTHR - Free Report) reported earnings of $2.19 per share for the fourth quarter of 2020, which missed the Zacks Consensus Estimate of $2.97 per share. Earnings were higher than the year-ago earnings of $1.20 per share.
The abovementioned earnings include the impact of share-based compensation expenses, unrealized gains/losses on privately-held companies, license related fees and other items. Excluding these items, adjusted earnings were $3.31 per share, up 68.9% year over year.
Revenues for the reported quarter were $384.9 million, which beat the Zacks Consensus Estimate of $356.0 million. Revenues rose 24% year over year.
United Therapeutics markets four products for pulmonary arterial hypertension (PAH) — Remodulin, Tyvaso, Adcirca and Orenitram. Higher sales of Orenitram, Remodulin and Tyvaso offset lower sales of Unituxin and Adcirca in the quarter.
This year so far, the stock has risen 14.4% compared with the
industry’s increase of 3%.
Quarter in Detail
Orenitram sales amounted to $74.0 million in the reported quarter, up 45% year over year due to higher volumes resulting from patient growth, following an expanded Orenitram label, reflecting the FREEDOM-EV results.
Tyvaso sales totaled $131.7 million, up 44% year over year, gaining from higher volumes as a result of patient growth and price increases. Remodulin sales were $127.9 million, up 19% year over year.
Meanwhile, fourth-quarter 2019 revenues were hurt by a “corrected order” by a U.S. distributor, which reduced revenues in the quarter. Excluding this one-time 2019 operation in the distributor order patterns, U.S. Remodulin sales would have been flat while sales of Tyvaso and Orenitram would have risen 27% and 30%, respectively in the fourth quarter of 2020.
Adcirca sales were $21.6 million, down 22% year over year as generic competition resulted in continued erosion of market share in the quarter. 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.
Unituxin’s (for the treatment of pediatric patients with high-risk neuroblastoma) sales of $29.7 million were down 12% year over year.
Research and development (R&D) expenses were $126.1 million in the quarter, up 11% year over year. Selling, general and administrative expense rose 51% to $158.7 million in the quarter.
Total revenues for 2020 came in at $1.48 billion, up 2.4% year over year. Adjusted earnings were $14.46 per share, up 11.8% year over year.
United Therapeutics is working on expanded indications for Orenitram and Tyvaso. A supplemental new drug application to expand the Tyvaso label to include data from the phase III INCREASE study is under review with the FDA with a decision expected in April 2021. The pivotal phase III INCREASE study evaluated Tyvaso in patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD), a lung disease for which no treatments are presently approved. If approved, the label update will increase Tyvaso's eligible U.S. population by more than 30,000 patients.
Other important phase III programs include Tyvaso dry powder inhaler/Tyvaso DPI (PAH — phase III BREEZE study), Tyvaso in PAH patients who have COPD (phase III PERFECT study), Tyvaso in patients with chronic fibrosing interstitial lung disease (TETON-phase III to begin soon) and Ralinepag (PAH — phase III ADVANCE studies). Last month, the company announced that the BREEZE study met its primary objective of demonstrating safety and tolerability of Tyvaso DPI in PAH patients who transitioned from Tyvaso Inhalation Solution. A NDA seeking approval of Tyvaso DPI for indications covering PAH and PH-ILD is expected to be filed in April.
The company is also working on bringing multiple second generation Remodulin drug delivery systems to drive sales growth. These includes RemUnity, a pre-filled, semi-disposable pump system for subcutaneous delivery of Remodulin, which the company has developed in partnership with DEKA. United Therapeutics launched the product commercially this month, much delayed from previous expectations due to pandemic-related issues.
United Therapeutics has developed an Implantable System for Remodulin (ISR), an implantable pump for delivering Remodulin intravenously in collaboration with
Medtronic ( MDT Quick Quote MDT - Free Report) . Though Medtronic’s pre-market approval for the ISR device was given approval by the FDA in December 2017, the launch is pending on the satisfaction of further regulatory requirements by Medtronic, which are expected to be fulfilled in the fourth quarter of 2021. Launch of the ISR is expected in late 2021.
Also, United Therapeutics expects to resubmit the NDA for Trevyent disposable treprostinil pump system for the subcutaneous treatment of PAH in 2021. The NDA was earlier given a complete response letter by the FDA in April 2020.
In 2021, United Therapeutics plans to launch four new products and indications, while Remunity Pump has already been launched. Tyvaso Inhalation Solution in PH-ILD, Tyvaso DPI and ISR for Remodulin are expected to be launched later in the year.
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