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UTHR Q1 Earnings Miss Estimates, Shares Jump on Strong Outlook

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Key Takeaways

  • UTHR Q1 EPS and revenues missed estimates, but shares rose on long-term growth optimism.
  • United Therapeutics reported strong phase III data for Tyvaso in IPF and ralinepag in PAH.
  • UTHR plans FDA filings for nebulized Tyvaso in IPF and ralinepag later in 2026.

United Therapeutics (UTHR - Free Report) reported first-quarter 2026 earnings per share (EPS) of $5.82, which missed the Zacks Consensus Estimate of $6.73. Earnings decreased 12% year over year.

United Therapeutics markets four products for pulmonary arterial hypertension (PAH): Tyvaso, Orenitram, Adcirca and Remodulin. It also markets Unituxin for treating pediatric patients with high-risk neuroblastoma.

Revenues in the first quarter totaled $781.5 million, which missed the Zacks Consensus Estimate of $800 million. Revenues decreased 2% year over year.

UTHR's Q1 Earnings in Detail

A key driver of the company’s top line is Tyvaso products. United Therapeutics markets two versions of Tyvaso: Tyvaso dry powder inhalation (DPI) and nebulized Tyvaso. Both versions are approved for the treatment of PAH and pulmonary hypertension associated with interstitial lung disease (PH-ILD) indications.

Combined Tyvaso sales totaled $457.5 million, down 2% year over year due to lower revenues from nebulized Tyvaso. Tyvaso sales fell short of the Zacks Consensus Estimate of $469 million.

Tyvaso DPI generated revenues of $330.3 million, climbing 9% year over year due to an increase in patient demand and some pricing benefits.

Revenues from nebulized Tyvaso (treprostinil) were $127.2 million, down 22%, largely due to reduced U.S. demand and weaker international sales, despite modest price increases.

Sales of Orenitram rose 12% year over year to $135.6 million, primarily driven by higher volumes sold.

Remodulin (including Remunity Pump) sales declined 8% year over year to $126.6 million.

Unituxin sales were down 8% year over year to $53.6 million.

Adcirca sales were $2.9 million, down 52% year over year.

Research and development expenses were $138.2 million in the quarter, down 7% year over year, mainly due to lower milestone payments for drug delivery device technologies, partly offset by higher personnel costs.

Selling, general and administrative expenses increased 8% to $184.1 million in the quarter.

As of March 31, 2026, UTHR had cash, cash equivalents and investments of $3.8 billion compared with $4.6 billion as of Dec. 31, 2025. The company had no debt.

UTHR's Pipeline & Other Updates

United Therapeutics’ key phase III programs include Tyvaso in patients with various forms of chronic fibrosing interstitial lung disease (TETON studies) and oral ralinepag in PAH indications (ADVANCE OUTCOMES study).

The TETON program comprises two late-stage parallel studies — TETON-1 (conducted in the United States and Canada) and TETON-2 (internationally). Top-line data from TETON-2 were previously reported in September 2025.

In March, the company unveiled robust data from the TETON-1 study evaluating nebulized Tyvaso for the treatment of patients with idiopathic pulmonary fibrosis (IPF), a devastating lung disease with limited treatment options.

The study demonstrated a statistically significant improvement in lung function in IPF patients, with a 130.1 mL increase in forced vital capacity (FVC) at 52 weeks from baseline versus placebo. The study successfully met its primary endpoint. The therapy also significantly reduced the risk of clinical worsening and showed favorable trends across key secondary endpoints. Per management, the exceptional TETON-1 study data surpassed the strong outcomes from the TETON-2 study of Tyvaso.

Based on data from the TETON-1 and TETON-2 studies, United Therapeutics intends to submit a supplemental new drug application to the FDA by the end of summer, seeking priority review for the approval of nebulized Tyvaso in IPF.

Besides IPF, UTHR is also conducting a phase III TETON PPF study to evaluate the therapy in progressive pulmonary fibrosis. Eligible patients who completed the TETON-1 study could enroll in TETON-OLE, an ongoing open-label extension study assessing the long-term safety and tolerability of nebulized Tyvaso in fibrotic lung disease.

In early March, United Therapeutics also announced data from the phase III ADVANCE OUTCOMES Study. The study met both its primary and secondary endpoints.

Data from the study demonstrated that treatment with ralinepag reduced the risk of clinical worsening by 55% versus placebo and showed durable efficacy in delaying disease progression in patients with PAH. Statistically significant improvements were also observed in key secondary endpoints such as six-minute walk distance and changes in N-terminal pro-B-type natriuretic peptide levels. The company intends to submit a new drug application for ralinepag to the FDA in the second half of 2026.

Management expressed strong confidence in the company’s pipeline. The company believes that Tyvaso for IPF and ralinepag for PAH, both backed by completed phase III studies, have the potential to become best-in-class therapies. Management further stated that each drug could individually generate revenues exceeding the company’s current annual sales base, supporting its target of growing the annual revenue run rate from $3 billion to $4 billion by the end of 2027. This led the stock to rise 4% on Wednesday, despite the earnings and sales miss in the first quarter.

Year to date, shares of United Therapeutics have rallied 22.5% against the industry’s 1.3% decline.

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UTHR's Zacks Rank & Stocks to Consider

United Therapeutics currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the biotech sector are Amarin Corporation (AMRN - Free Report) and Indivior Pharmaceuticals (INDV - Free Report) , each currently sporting a Zacks Rank #1 (Strong Buy) and Catalyst Pharmaceuticals (CPRX - Free Report) , which carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Over the past 60 days, estimates for Amarin’s 2026 loss per share have narrowed from $7.01 to $6.36. Over the same period, loss per share estimates for 2027 have also narrowed from $5.50 to $4.64. AMRN shares have risen 6.8% year to date.

Amarin’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 50.02%.

Over the past 60 days, estimates for Indivior Pharmaceuticals’ 2026 earnings per share have increased from $3.03 to $3.35. Over the same period, EPS estimates for 2027 have risen to $3.69 from $3.46. INDV shares have risen 13.1% year to date.

Indivior Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 65.44%.

Over the past 60 days, estimates for Catalyst Pharmaceuticals’ 2026 earnings per share have declined from $2.82 to $2.79. Over the same period, EPS estimates for 2027 have surged from $3.20 to $3.28. CPRX shares have gained 30.8% year to date.

Catalyst Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 35.19%.

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