Nebulized Tyvaso
Search documents
UTHR Stock Rises 12.5% on Promising Data From TETON-1 Tyvaso Study
ZACKS· 2026-03-31 17:06
Core Insights - United Therapeutics (UTHR) shares increased by 12.5% following the announcement of positive results from the phase III TETON-1 study, which evaluated nebulized Tyvaso for idiopathic pulmonary fibrosis (IPF) treatment [1][8]. Study Details - The TETON program includes two late-stage studies: TETON-1 in the U.S. and Canada, and TETON-2 internationally, with TETON-2 results reported in September 2025 [2]. - The TETON-1 study showed a statistically significant improvement in lung function, with a 130.1 mL increase in forced vital capacity (FVC) at 52 weeks compared to placebo, successfully meeting its primary endpoint [5][8]. - The therapy also significantly reduced the risk of clinical worsening and showed favorable trends in secondary endpoints, including delayed time to first acute IPF exacerbation and improvements in quality of life scores [6][9]. Safety and Efficacy - Nebulized Tyvaso demonstrated consistent benefits across all patient subgroups, with a safety profile consistent with prior studies and no new safety concerns identified [7][10]. - Management noted that the TETON-1 data surpassed the outcomes from TETON-2, indicating a significant advancement for IPF patients [9]. Future Plans - United Therapeutics plans to file a supplemental new drug application with the FDA by summer, seeking priority review for nebulized Tyvaso in IPF based on the strong results from both TETON-1 and TETON-2 studies [10]. - The company is also conducting a phase III TETON PPF study to evaluate the therapy in progressive pulmonary fibrosis, with an ongoing open-label extension study for long-term safety assessment [11]. Stock Performance - Year-to-date, UTHR shares have risen by 20.8%, contrasting with a 4.3% decline in the industry [4].
Compared to Estimates, United Therapeutics (UTHR) Q4 Earnings: A Look at Key Metrics
ZACKS· 2026-02-25 18:30
Core Insights - United Therapeutics reported revenue of $790.2 million for the quarter ended December 2025, reflecting a 7.4% increase year-over-year, but fell short of the Zacks Consensus Estimate by 1.88% [1] - The company's EPS was $7.70, up from $6.19 in the same quarter last year, exceeding the consensus estimate of $6.78 by 13.5% [1] Revenue Breakdown - Revenues from the Rest-of-World segment were $37.4 million, surpassing the estimated $28.71 million, marking a 23.8% increase year-over-year [4] - U.S. revenues totaled $752.8 million, slightly below the estimated $753.92 million, with a year-over-year growth of 6.7% [4] - Remodulin in the U.S. generated $104.3 million, underperforming the estimate of $112 million, representing a year-over-year decline of 4.8% [4] - Tyvaso in the U.S. reported revenues of $457.2 million, slightly below the estimate of $464.91 million, with a year-over-year increase of 11.6% [4] - Adcirca revenues were $7.8 million, exceeding the estimate of $4.62 million, showing a significant year-over-year increase of 66% [4] - Orenitram generated $121.2 million, closely matching the estimate of $121.24 million, with a year-over-year growth of 12.4% [4] - Other products brought in $6.6 million, surpassing the average estimate of $5.1 million, reflecting a 20% year-over-year increase [4] - Unituxin revenues were $62.3 million, exceeding the estimate of $51.29 million, but showing a year-over-year decline of 7.7% [4] - Nebulized Tyvaso reported $125.7 million, below the estimate of $144.35 million, with a year-over-year decline of 11.9% [4] - Tyvaso DPI revenues were $338.6 million, exceeding the estimate of $313.3 million, marking a 23.9% increase year-over-year [4] Stock Performance - United Therapeutics shares have returned -0.7% over the past month, compared to a -0.3% change in the Zacks S&P 500 composite [3] - The stock currently holds a Zacks Rank 4 (Sell), indicating potential underperformance relative to the broader market in the near term [3]
Unveiling United Therapeutics (UTHR) Q4 Outlook: Wall Street Estimates for Key Metrics
ZACKS· 2026-02-20 15:15
Core Viewpoint - Analysts forecast that United Therapeutics (UTHR) will report quarterly earnings of $6.78 per share, reflecting a year-over-year increase of 9.5%, with anticipated revenues of $805.31 million, marking a 9.4% increase compared to the previous year [1]. Earnings Estimates - The consensus EPS estimate for the quarter has been revised downward by 0.2% over the past 30 days, indicating a collective reassessment by analysts [2]. - Changes in earnings estimates are crucial for predicting investor reactions, as empirical studies show a strong correlation between earnings estimate revisions and short-term stock price performance [3]. Revenue Estimates - Analysts estimate 'Revenues- Adcirca' will reach $4.62 million, a decrease of 1.6% from the year-ago quarter [5]. - The average prediction for 'Revenues- Orenitram' is $121.24 million, indicating a year-over-year increase of 12.5% [5]. - The consensus for 'Revenues- Other products' stands at $5.10 million, reflecting a year-over-year decline of 7.3% [5]. - 'Revenues- Remodulin' is expected to be $131.46 million, showing a decrease of 2.3% year over year [6]. - 'Revenues- Tyvaso' is projected to reach $488.25 million, indicating a year-over-year increase of 17.4% [6]. - 'Revenues- Unituxin' is expected to be $51.29 million, suggesting a significant decline of 24% year over year [6]. - 'Revenues- Nebulized Tyvaso' is forecasted at $144.35 million, reflecting a slight increase of 1.2% from the prior year [7]. - 'Revenues- Tyvaso DPI' is expected to reach $313.30 million, indicating a year-over-year increase of 14.7% [7]. - 'Revenues- United States' is projected to be $753.92 million, reflecting a change of 6.8% from the prior-year quarter [7]. - 'Revenues- Rest-of-World' is estimated at $28.71 million, suggesting a year-over-year decline of 4.9% [8]. Stock Performance - Over the past month, shares of United Therapeutics have returned +1.8%, contrasting with the Zacks S&P 500 composite's -0.8% change [8]. - Currently, UTHR holds a Zacks Rank 4 (Sell), indicating potential underperformance relative to the overall market in the near future [8].
Compared to Estimates, United Therapeutics (UTHR) Q3 Earnings: A Look at Key Metrics
ZACKS· 2025-10-29 14:36
Core Insights - United Therapeutics reported revenue of $799.5 million for the quarter ended September 2025, reflecting a year-over-year increase of 6.8% [1] - The company's EPS was $7.16, up from $6.39 in the same quarter last year, indicating a positive earnings performance [1] - Revenue fell short of the Zacks Consensus Estimate of $817.8 million, resulting in a surprise of -2.24%, while EPS exceeded expectations by 3.92% [1] Revenue Breakdown - U.S. revenues were $774.8 million, compared to an estimated $810.22 million, marking an 8% increase year-over-year [4] - Revenues from the Rest-of-World segment were $24.7 million, below the estimated $33.09 million, representing a decline of 21.8% year-over-year [4] - Tyvaso generated $470.1 million in U.S. revenue, falling short of the $507.8 million estimate, while Unituxin brought in $46.5 million, below the $62.24 million estimate [4] - Adcirca revenues were $9.7 million, exceeding the $5.49 million estimate, with a significant year-over-year increase of 38.6% [4] - Orenitram revenues reached $131.1 million, slightly above the $124.02 million estimate, reflecting a 15.8% year-over-year increase [4] - Tyvaso DPI revenues were $336.2 million, surpassing the $322.54 million estimate, with a year-over-year growth of 22.4% [4] - Other products generated $6.9 million, exceeding the $5.35 million estimate, with a year-over-year increase of 25.5% [4] Stock Performance - Over the past month, United Therapeutics shares have returned -0.9%, contrasting with the Zacks S&P 500 composite's increase of 3.8% [3] - The stock currently holds a Zacks Rank 3 (Hold), suggesting it may perform in line with the broader market in the near term [3]
Compared to Estimates, United Therapeutics (UTHR) Q2 Earnings: A Look at Key Metrics
ZACKS· 2025-07-30 14:31
Core Viewpoint - United Therapeutics reported a revenue of $798.6 million for the quarter ended June 2025, reflecting an 11.7% increase year-over-year, and an EPS of $6.41, up from $5.85 in the previous year [1] Revenue Performance - U.S. revenues reached $759.8 million, exceeding the average estimate of $749.74 million by analysts, marking a 12.5% increase year-over-year [4] - Revenues from the Rest-of-World segment were $38.8 million, slightly above the average estimate of $33.98 million, but represented a 2.3% decline year-over-year [4] - Tyvaso generated $455.3 million in U.S. revenues, slightly above the average estimate of $452.61 million [4] - Unituxin in the U.S. brought in $55.4 million, surpassing the average estimate of $53.07 million [4] - Adcirca revenues were $6.5 million, exceeding the average estimate of $4.81 million, reflecting a 14% increase year-over-year [4] - Orenitram generated $123.9 million, above the average estimate of $118.65 million, with a 15.7% year-over-year increase [4] - Tyvaso reported $469.6 million, slightly below the average estimate of $473.16 million, but still a 17.9% increase year-over-year [4] - Remodulin revenues were $134.7 million, below the average estimate of $137.99 million, representing an 8.6% decline year-over-year [4] - Unituxin generated $58.4 million, exceeding the average estimate of $55.58 million, with a 13% year-over-year increase [4] - Tyvaso DPI revenues were $315.2 million, in line with the average estimate of $313.48 million [4] - Nebulized Tyvaso brought in $154.4 million, slightly below the average estimate of $154.53 million [4] - Other products generated $5.5 million, exceeding the average estimate of $4.95 million, reflecting a 12.2% year-over-year increase [4] Stock Performance - United Therapeutics shares returned +2.3% over the past month, compared to the Zacks S&P 500 composite's +3.4% change [3] - The stock currently holds a Zacks Rank 3 (Hold), indicating potential performance in line with the broader market in the near term [3]
United Therapeutics (UTHR) Reports Q1 Earnings: What Key Metrics Have to Say
ZACKS· 2025-04-30 14:35
Core Insights - United Therapeutics reported $794.4 million in revenue for Q1 2025, a 17.2% increase year-over-year, with an EPS of $6.63 compared to $6.17 a year ago [1] - The revenue exceeded the Zacks Consensus Estimate of $726.19 million by 9.39%, and the EPS also surpassed the consensus estimate of $6.29 by 5.41% [1] Revenue Breakdown - U.S. Revenues: $749.60 million, exceeding the average estimate of $695.02 million, representing a 16.9% year-over-year increase [4] - Rest-of-World Revenues: $44.80 million, surpassing the average estimate of $27.05 million, reflecting a 23.8% year-over-year increase [4] - Tyvaso Revenue in the U.S.: $441.10 million, compared to the average estimate of $405.30 million [4] - Remodulin Revenue in the U.S.: $120.20 million, exceeding the average estimate of $113.15 million [4] - Adcirca Revenue: $6 million, below the average estimate of $4.77 million, showing a 6.3% decrease year-over-year [4] - Orenitram Revenue: $120.70 million, surpassing the average estimate of $111.47 million, with a 13.7% year-over-year increase [4] - Tyvaso Revenue: $466.30 million, exceeding the average estimate of $413.63 million, with a remarkable 105% year-over-year increase [4] - Remodulin Revenue: $138.20 million, above the average estimate of $126.42 million, reflecting an 8% year-over-year increase [4] - Unituxin Revenue: $58.20 million, below the average estimate of $62.95 million, showing a 0.3% decrease year-over-year [4] - Tyvaso DPI Revenue: $302.50 million, exceeding the average estimate of $271.57 million [4] - Nebulized Tyvaso Revenue: $163.80 million, surpassing the average estimate of $137.44 million [4] - Other Products Revenue: $5 million, below the average estimate of $5.68 million, reflecting a 19.4% decrease year-over-year [4] Stock Performance - Shares of United Therapeutics have returned -2% over the past month, compared to the Zacks S&P 500 composite's -0.2% change [3] - The stock currently holds a Zacks Rank 3 (Hold), indicating potential performance in line with the broader market in the near term [3]