United Therapeutics Corporation · NASDAQ:UTHR
United Therapeutics — Technical Presentation (September 2025)
26 slides from United Therapeutics's technical presentation, Sep 28, 2025
Slide 1: Phase 3 TETON-2 Results Webcast
United Therapeutics Corporation Phase 3 TETON-2 Results Webcast SEPTEMBER 28, 2025
Slide 2: Safe Harbor Statement
INTRODUCTION 2 2 Safe Harbor Statement All statements in this presentation are made as of September 28, 2025. We undertake no obligation to publicly update or revise these statements, whether as a result of new information, future events, or otherwise. Statements included in this presentation that a
Slide 3: Today's Speakers
3 INTRODUCTION Today’s Speakers Dr. Leigh Peterson Dr. Steve Nathan Executive Vice President, Schar Chair, Advanced Lung Disease and Lung Product Development and Transplant Program, Inova Fairfax Hospital & Xenotransplantation Chair of the TETON Steering Committee Dr. Peter Smith Dr. C.Q. Deng Senio
Slide 4: Dr. Leigh Peterson
4 Dr. Leigh Peterson EVP, PRODUCT DEVELOPMENT AND XENOTRANSPLANTATION
Slide 5: TETON-2 Headline Conclusions
5 TETON-2 RESULTS TETON-2 Headline Conclusions 1 2 3 The study met its primary The study also met Nebulized Tyvaso endpoint of change from statistical significance for (inhaled treprostinil) was several key secondary well tolerated, and the baseline in absolute FVC efficacy endpoints, such safety pr
Slide 6: Dr. Peter Smith
6 Dr. Peter Smith SVP, PRODUCT DEVELOPMENT AND LEAD FOR THE GLOBAL TETON PROGRAM
Slide 7: TETON Study Design
7 TETON DESIGN TETON 2 Study Design1 PRIMARY ENDPOINT STUDY VISIT SCHEDULE Change in absolute FVC2 from baseline to week 52 SECONDARY ENDPOINTS Time to clinical worsening event3 Time to first acute exacerbation of IPF4 Overall survival at week 52 Percent predicted FVC at week 52 K-BILD5 score at wee
Slide 8: TETON Study Design
8 TETON DESIGN TETON 2 Study Design1 SELECTED KEY INCLUSION CRITERIA SELECTED KEY EXCLUSION CRITERIA Age 40+ Primary obstructive disease, FEV17/FVC < 0.70 FVC2 ≥ 45% predicted >10 L/min of supplemental oxygen use at baseline If on pirfenidone or nintedanib: stable dose for ≥ 30 days prior to baselin
Slide 9: TETON-2 Baseline Characteristics Balanced Between Treatment Groups
9 TETON BASELINE TETON-2 Baseline Characteristics Balanced Between Treatment Groups Inhaled Treprostinil Placebo (n=298) (n=295) Age (yrs) 71.9 71.6 Male % 79.9% 80.3% Female % 20.1% 19.7% Years since diagnosis 4.0 3.7 FVC (mL), mean 2683.7 2708.3 FVC (% predicted), mean 76.4% 77.2% DLCO (% predicte
Slide 10: Dr. Steve Nathan
10 Dr. Steve Nathan SCHAR CHAIR, ADVANCED LUNG DISEASE AND LUNG TRANSPLANT PROGRAM, INOVA FAIRFAX HOSIPITAL & CHAIR OF THE TETON STEERING COMMITTEE
Slide 11: Primary Endpoint
11 TETON-2 RESULTS Primary Endpoint Change from Baseline in Absolute FVC at 52 Weeks 95.6 mL* (95% CI, 52.2, 139.0) P<0.0001 *(H-L estimate) Hodges-Lehmann estimate and non-parametric aligned stratified rank Wilcoxon test
Slide 12: Primary Endpoint
12 TETON-2 RESULTS Primary Endpoint TETON Forest Plot of FVC by Visit
Slide 13: Change by Background Therapy
13 TETON-2 RESULTS Change by Background Therapy No Background Therapy Background Nintedanib Background Pirfenidone 43.9 mL (H-L estimate) 97.6 mL (H-L estimate) 127.9 mL (H-L estimate) (95% CI, -45.0, 132.8); (95% CI, 26.1, 169.2); (95% CI, 58.8, 196.9); P=0.3329 P=0.0075 P=0.0003 *Imputed Medians
Slide 14: Secondary Endpoints
14 TETON-2 RESULTS Secondary Endpoints Time to First Clinical Worsening Event Inhaled treprostinil resulted in a 29% reduction in risk of clinical worsening compared to placebo (cox-regression: P=0.0190) 81 (27.2%) inhaled treprostinil and 115 (39%) placebo patients experienced clinical worsening (c
Slide 15: Secondary Endpoints
15 TETON-2 RESULTS Secondary Endpoints Summary of First Clinical Worsening Events Inhaled Treprostinil Placebo P value (n=298) (n=295) Clinical Worsening Event 81 (27.2%) 115 (39.0%) 0.0023 (chi-square) Death (all cause) 4 (1.3%) 3 (1.0%) Respiratory Hospitalization 30 (10.1%) 38 (12.9%) (adjudicate
Slide 16: Secondary Endpoints
16 TETON-2 RESULTS Secondary Endpoints Time to First Acute Exacerbation of IPF Inhaled treprostinil resulted in a 46% reduction in risk of first acute exacerbation of IPF (cox-regression: P=0.1368) 9 (3%) inhaled treprostinil and 17 (5.8%) placebo patients experienced a first acute exacerbation of I
Slide 17: Secondary Endpoints
17 TETON-2 RESULTS Secondary Endpoints Overall Survival at Week 52 Inhaled treprostinil resulted in a 23% reduction in the risk of death (cox- regression: P=0.3986) 19 (6.4%) inhaled treprostinil and 24 (8.1%) placebo patients died prior to week 52 (chi- square: P=0.4087)
Slide 18: Secondary Endpoints
18 TETON-2 RESULTS Secondary Endpoints Change from Baseline in % Predicted FVC at Week 52 2.7%* (95% CI, 1.5, 4.0) P<0.0001 *(H-L estimate) Hodges-Lehmann estimate and non-parametric aligned stratified rank Wilcoxon test
Slide 19: Secondary Endpoints
19 TETON-2 RESULTS Secondary Endpoints Change from Baseline in K-BILD Total and Domain Scores 2.73 1.69 2.96 2.29 (H-L estimate) (95% CI, 0.23, 5.69) (95% CI, 0.29, 5.17) (95% CI, -1.61, 4.98) (95% CI, 0.5, 4.08); P=0.0338 P=0.0282 P=0.3156 P=0.0124 (H-L estimates) *Imputed Medians
Slide 20: Secondary Endpoints
20 TETON-2 RESULTS Secondary Endpoints Change from Baseline in % Predicted DLCO (ppDLCO) 1.91% (95% CI, 0.07, 3.75); P=0.0416 (H-L estimate) *Imputed Median
Slide 21: Forest Plot of Subgroup Analyses of FVC (mL) at Week 52
21 TETON-2 RESULTS Forest Plot of Subgroup Analyses of FVC (mL) at Week 52 Hodges-Lehmann location Hodges-Lehmann location shift shift
Slide 22: Summary of Adverse Events
22 TETON-2 RESULTS Summary of Adverse Events Inhaled Treprostinil Placebo (n=298) (n=295) Total number of AEs 1558 1302 Number of subjects with at least one AE 273 (91.6%) 264 (89.5%) Total number of SAEs 115 96 Number of subjects with at least one SAE 75 (25.2%) 68 (23.1%) Total number of Drug-rela
Slide 23: Summary of Common Adverse Events
23 TETON-2 RESULTS Summary of Common Adverse Events Inhaled Treprostinil Placebo (n=298) (n=295) Cough 144 (48.3%) 71 (24.1%) Headache 59 (19.8%) 35 (11.9%) Diarrhea 41 (13.8%) 50 (16.9%) Dyspnea 36 (12.1%) 31 (10.5%) Bronchitis 30 (10.1%) 30 (10.2%) Dizziness 29 (9.7%) 19 (6.4%) Worsening idiopathi
Slide 24: TETON-2 Headline Conclusions
24 TETON-2 RESULTS TETON-2 Headline Conclusions 1 2 3 The study met its primary The study also met Nebulized Tyvaso was endpoint of change from statistical significance for well tolerated, and the several key secondary safety profile was baseline in absolute FVC efficacy endpoints, such consistent w
Slide 25: Dr. Leigh Peterson
25 Dr. Leigh Peterson EVP, PRODUCT DEVELOPMENT AND XENOTRANSPLANTATION
Slide 26: Q&A
26 Q&A Dr. Leigh Peterson EVP, Product Development and Xenotransplantation Dr. Steve Nathan Schar Chair, Advanced Lung Disease and Lung Transplant Program, Inova Fairfax Hospital & Chair of the TETON Steering Committee Dr. Peter Smith SVP, Product Development and Lead for the Global TETON Program Dr
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