United Therapeutics Corporation · NASDAQ:UTHR
United Therapeutics — Q2 2025 Earnings Presentation
61 slides from United Therapeutics's earnings presentation, Jul 30, 2025
Slide 1: United Therapeutics Corporation Second Quarter 2025 Corporate Update
United Therapeutics Corporation Second Quarter 2025 Corporate Update JULY 30, 2025
Slide 2: Safe Harbor Statement
INTRODUCTION 2 2 Safe Harbor Statement All statements in this presentation are made as of July 30, 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 are no
Slide 3: Today's Speakers
3 INTRODUCTION Today’s Speakers Dr. Martine Rothblatt Michael Benkowitz Chairperson and Chief Executive Officer President and Chief Operating Officer
Slide 4: Other Executives Present Today
4 INTRODUCTION Other Executives Present Today James Edgemond C.Q. Deng Chief Financial Officer and Treasurer Senior Vice President, Biostatistics, Statistical Programming & Data Management Dr. Leigh Peterson Dr. Gil Golden Executive Vice President, Executive Vice President, Chief Medical Officer Pro
Slide 5: Upcoming Investor Conferences
5 INTRODUCTION Upcoming Investor Conferences Morgan Stanley Global Bernstein’s Second Annual Healthcare Conference Healthcare Forum September 8, 2025 September 23, 2025
Slide 6: Upcoming Medical Conferences
6 INTRODUCTION Upcoming Medical Conferences World Transplant 18th Congress of the Congress 2025 International August 2-6, 2025 Xenotransplantation Association September 30 – October 3, 2025 European American College of Respiratory Society Chest Physicians Congress CHEST 2025 Annual September 27 - Oc
Slide 7: Dr. Martine Rothblatt
7 Dr. Martine Rothblatt CHAIRPERSON AND CHIEF EXECUTIVE OFFICER
Slide 8: 2Q 2025 Performance Summary
8 2Q 2025 Performance Summary Product Product Revenue Percent Change1 $1.4 B Tyvaso DPI®/ Nebulized Tyvaso® $470 M 18% TTM Operating Cash Flow Remodulin® $135 M 9% $5.0 B Cash, Cash Equivalents, & Orenitram® $124 M 16% Marketable Investments Unituxin® $58 M 13% Highest Quarterly Tyvaso3, Orenitram,
Slide 9: Positioned for Multiple Waves of Growth
9 HOW WE OPERATE Positioned for Multiple Waves of Growth1 Revenue $16B REVOLUTION Xeno and Organ Alternatives $8B INNOVATION Tyvaso IPF/PPF & Ralinepag PAH $4B FOUNDATION Current Commercial Portfolio $3B Today Future 1. Illustrative purposes only. Time
Slide 10: Development Engine Addressing Unmet Needs
10 01 PIPELINE Development Engine Addressing Unmet Needs NON-REGISTRATION REGISTRATION FILED APPROVED ® Tyvaso TETON 1 – Idiopathic Pulmonary Fibrosis – U.S. and Canada TETON 2 – Idiopathic Pulmonary Fibrosis – ROW1 TETON PPF – Progressive Pulmonary Fibrosis Ralinepag VISIT THE NEW ADVANCE OUTCOMES
Slide 11: Repurchase Authorization Demonstrates Commitment to Balanced Capital Allocation
11 CAPITAL ALLOCATION Repurchase Authorization Demonstrates Our Commitment to Balanced Capital Allocation Strong financial position and robust balance sheet $1 billion Confidence in upcoming catalysts and undervalued share price $1.0 billion Cash & Equivalents4 Ample remaining capital to meet mid- a
Slide 12: Foundation, Innovation, Revolution
12 FOUNDATION INNOVATION REVOLUTION Tyvaso DPI Tyvaso DPI Xenotransplantation Nebulized Tyvaso Nebulized Tyvaso Regenerative Medicine Orenitram Ralinepag 3D Printed Organ Remodulin EVLP5 Alternatives Unituxin Bio-Artificial Organ PAH Alternatives PAH1 PH-ILD PH-ILD2 IPF3 XENO AND PPF4 ORGAN ALTERNAT
Slide 13: Michael Benkowitz
13 Michael Benkowitz PRESIDENT AND CHIEF OPERATING OFFICER
Slide 14: Continued Strong Revenue Growth in 2Q/25
14 COMMERCIAL EXECUTION Continued Strong Revenue Growth in 2Q/25 Quarterly revenue, millions USD Tyvaso3, worldwide 800 ▲ 18% y/y1 to $470M 700 Remodulin, worldwide 17% 600 CAGR2 ▼ 9% y/y to $135M 500 Orenitram 400 ▲ 16% y/y to $124M 300 Unituxin, worldwide ▲ 13% y/y to $58M 200 100 Total Revenue ▲
Slide 15: Tyvaso DPI is the Best Positioned Inhaled Prostacyclin
15 TYVASO DPI Tyvaso DPI is the Best Positioned Inhaled Prostacyclin DOSING No commercially available treprostinil DPI has published data at higher doses than Tyvaso DPI TOLERABILITY Tolerability of Tyvaso DPI has been shown to increase over time1 PARTICLE DEPOSITION Tyvaso DPI’s low flow rate and o
Slide 16: Dosing for Tyvaso DPI is not Limited
16 TYVASO DPI DOSING Dosing for Tyvaso DPI is not Limited TYVASO DPI HAS BEEN STUDIED AND PUBLISHED AT HIGHER DOSES THAN YUTREPIA THERE IS NO 33 MAXIMUM Nebulized 27 22% Breath LABELED DOSE Nebulized HIGHER Equivalents DOSES (176mcg) WITH Breath Equivalents IN PUBLISHED TYVASO DPI.1 (238.5mcg) CLINI
Slide 17: Tyvaso DPI Tolerability Increases Over Time
17 TYVASO DPI TOLERABILITY Tyvaso DPI Tolerability Increases Over Time The BREEZE study and its Optional Extension Phase The INSPIRE study and its open label extension demonstrated that key tolerability issues like cough and showed a worsening over time of these key throat irritation decrease over t
Slide 18: Tyvaso DPI is the Optimal Particle Size
18 TYVASO DPI ADMINISTRATION Tyvaso DPI is the Optimal Particle Size With a median size of 2.6 µm, Tyvaso DPI particles are in the optimal size range of 1-5 µm for pulmonary deposition1 FDKP2 microparticles rapidly dissolve in the neutral pH of the lungs and promote1: • Exposure to treprostinil • De
Slide 19: Tyvaso DPI is Easy to Use
19 TYVASO DPI USE Tyvaso DPI is Easy to Use 1 Tyvaso DPI1 Yutrepia2 Head positioning Breaths per cartridge/capsule 1 2 Flow rate required to dispense powder 20 L/min 99 L/min3 Daily cleaning required No Yes Refrigeration required by patient No No 1. Tyvaso DPI prescribing information. 2. Yutrepia pr
Slide 20: Tyvaso DPI is the Best Positioned Inhaled Prostacyclin
20 TYVASO DPI Tyvaso DPI is the Best Positioned Inhaled Prostacyclin DOSING TOLERABILITY PARTICLE EASE OF USE DEPOSITION
Slide 21: Dr. Leigh Peterson
21 Dr. Leigh Peterson EVP, PRODUCT DEVELOPMENT AND XENOTRANSPLANTATION
Slide 22: IPF is a Large Corridor of Indifference
22 TETON MARKET IPF1 is a Large Corridor of Indifference Worldwide sales of branded pirfenidone and nintedanib4 $4 billion 100,000 PATIENTS AFFECTED IN THE U.S.1 30,000 TO 40,000 NEW CASES EACH YEAR IN THE U.S.1 ONLY 30% OF PATIENTS ARE ON IPF THERAPY DUE TO AE2 PROFILE3 $4 BILLION + WORLDWIDE SALES
Slide 23: Approved Therapies Only Slow the Rate of FVC Decline
23 TETON MARKET Approved Therapies Only Slow the Rate of FVC Decline nintedanib pirfenidone Adjusted annual rate of decline in FVC was -112.4 Mean change from baseline to month 12, -216 mL in mL/year with nintedanib and -223.3 ML/year with the pirfenidone group and -363 mL in the placebo placebo (di
Slide 24: Treprostinil Has Antifibrotic Properties
24 TETON MECHANISM OF ACTION Treprostinil Has Antifibrotic Properties TREPROSTINIL ANTI-FIBROTIC PATHWAYS1 EP2 activation2 ▼ fibroblast to myofibroblast differentiation ▼ fibroblast proliferation ▼ collagen overproduction DP1 activation3 ▼ inflammatory cell recruitment ▼ extracellular matrix synthes
Slide 25: Tyvaso for IPF
25 TETON RATIONALE Tyvaso for IPF1,2 MEANINGFUL, SUSTAINED FVC IMPROVEMENT The TETON studies evolved from UT-sponsored in vitro studies and FVC3 observations in INCREASE4 and INCREASE OLE5 IPF safety subgroup6 showed meaningful and sustained FVC improvement, including when placebo patients were cros
Slide 26: The TETON Program Consists of Three Studies
26 TETON PROGRAM The TETON Program Consists of Three Studies TETON 11 TETON 22 TETON PPF3 U.S. and Canada Argentina Italy United States Germany 598 patients4 Australia Mexico Canada Israel Belgium Netherlands Argentina New Zealand IDIOPATHIC PULMONARY Chile New Zealand Australia South Korea FIBROSIS
Slide 27: TETON Study Design
27 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 worsening3 Time to first acute exacerbation of IPF4 Overall survival at week 52 Predicted FVC at week 52 K-BILD5 score at week 52 DLCO6 at
Slide 28: TETON Study Design
28 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 ≥ 40 days prior to baseli
Slide 29: 2024 TETON 1 and TETON 2 Resizing
29 TETON DESIGN 2024 TETON 1 and TETON 2 Resizing KEY CONSIDERATIONS Blinded standard deviation observed to date 1,247 Use of background therapy 1,195 subjects at expansion 1,177 Patient retention 1,066 Regulatory feedback on sample size Regulatory feedback on statistical analysis Recent IPF1 clinic
Slide 30: TETON Baseline Characteristics Compare Favorably to Recent IPF Studies
30 TETON BASELINE TETON Baseline Characteristics Compare Favorably to Recent IPF1 Studies TETON 23 TETON 13 FIBRONEER-IPF4 pirfenidone5,6 nintedanib7 Age 72 73 70 67 67 Gender (male) 80% 77% 83% 74% 79% Time since diagnosis 3.6 3.8 3.5 1.5 1.6 Baseline FVC2 (mL) 2,696 2,724 2,842 N/A 2,719 % predict
Slide 31: Key Statistical Protocols
31 TETON STATS Key Statistical Protocols1 STUDY POWERING DROPOUTS/DISCONTINUATIONS 80% to detect an 80 mL change in FVC2 MMRM3 where the missing values will be 3 FIBRONEER-IPF was 90% powered to detect a 74 mL change in FVC implicitly imputed, or through multiple imputation DEATHS IN STUDY DMC5 REVI
Slide 32: Anticipated IPF Timeline
32 TETON TIMELINE Anticipated IPF Timeline1 Sept. 2025 1H 2026 2H 2026 2027 TETON 2 TETON 1 sNDA2 Launch 1. Timeline reflects UT's current expectation but is subject in all respect to clinical trial outcomes and the outcomes of FDA interactions. 2. sNDA = supplemental new drug application.
Slide 33: C.Q. Deng
33 C.Q. Deng SVP, BIOSTATISTICS, STATISTICAL PROGRAMMING & DATA MANAGEMENT
Slide 34: TPIP Data May Overstate Its True Potential
34 TPIP PHASE 2 DATA TPIP1 Data May Overstate Its True Potential IMBALANCED PATIENT Baseline characteristics not well balanced and may POPULATION favor active drug; baseline 6MWD2 not characteristic of current PAH3 studies AGGRESSIVE STATISTICAL Dropouts remarkably higher in the active arm that ANAL
Slide 35: Baseline 6MWD Was Not Reflective of Recent Studies
35 TPIP – IMBALANCED PATIENT POPULATION Baseline 6MWD1 Was Not Reflective of Recent Studies BASELINE 6MWD IN RECENT PAH STUDIES (in m) 417 419 408 401 401 356 45m+ LOWER BASELINE 6MWD TPIP STELLAR INSPIRE TORREY TROPOS BREEZE phase 2b sotatercept Yutrepia seralutinib cibotercept Tyvaso DPI 20252 202
Slide 36: Baseline 6MWD Was Not Balanced Between Arms
36 TPIP – IMBALANCED PATIENT POPULATION Baseline 6MWD1 Was Not Balanced Between Arms 23m The 6MWD spread between active and placebo arms was >3x more than 3x higher for the TPIP MORE SPREAD PAH9 phase 2b BETWEEN study compared to ARMS other recent PAH 7m exercise capacity 5m studies 0.4m 2m 2m ZENIT
Slide 37: Dropouts Were Remarkably Higher in the Active Arm
37 TPIP – IMBALANCED PATIENT POPULATION Dropouts Were Remarkably Higher in the Active Arm DROPOUT PERCENT BY ARM (ACTIVE/CONTROL) 13/115 subjects (11%) 10/120 7/69 10% of TPIP phase 2b 10/160 subjects patients on active drug subjects (8%) subjects discontinued therapy (6%) (10%) v. zero on placebo a
Slide 38: TPIP Phase 2b 6MWD Data May Be Positively Skewed
38 TPIP – AGGRESSIVE STATISTICAL ANALYSIS TPIP Phase 2b 6MWD1 Data May Be Positively Skewed MEDIAN V. MEAN IMPLY DATA SKEW This data skew could lead to the over-estimation of the treatment effect2 Mean ~20% higher 8 patients than median in excluded from active and ~40% endpoint DATA IMPUTATION lower
Slide 39: Weak Phase 2a in PH-ILD; No Evidence TPIP Will Succeed
39 TPIP PH-ILD Weak Phase 2a in PH-ILD1; No Evidence TPIP Will Succeed in a Confirmatory PH-ILD Study Small study with 3:1 No 6MWD3 baseline was randomization2 designed as given so relative health of a safety study, so efficacy participants can’t be fully Imbalanced ILD4 conclusions cannot be made d
Slide 40: TPIP Data May Overstate Its True Potential
40 TPIP DATA ANALYSIS TPIP1 Data May Overstate Its True Potential IMBALANCED AGGRESSIVE PATIENT STATISTICAL POPULATION ANALYSIS LACK OF CLARITY IN PH-ILD 1. TPIP = treprostinil palmitil inhalation powder.
Slide 41: Dr. Gil Golden
41 Dr. Gil Golden EVP AND CHIEF MEDICAL OFFICER
Slide 42: TPIP Faces a Challenging Path to Potential Approval
42 TPIP MARKET TPIP1 Faces a Challenging Path to Potential Approval NO NEAR-TERM PATH TO Lack of clear safety and efficacy in PH-ILD would carry MARKET IN IPF5 over to IPF and no clear path to market entry before 20346 UNPROVEN SAFETY Long term safety has not been proven MANY YEARS FROM MARKET TPIP
Slide 43: No Near-Term Path to Market for TPIP in IPF
43 TPIP MARKET - PATH No Near-Term Path to Market for TPIP in IPF1 TPIP is an ester prodrug in a lipid nanoparticle2 Clinical superiority or a major contribution in patient care would be required to bring an Ester prodrugs are considered to be a ester prodrug to market during a potential “same drug”
Slide 44: TPIP Long-Term Safety Has Not Been Proven
44 TPIP MARKET - SAFETY TPIP Long-Term Safety Has Not Been Proven ONLY MODEST SHORT-TERM Only 16-week safety data has been presented; long-term SAFETY DATA data from phase 2 OLE1 not expected until 20272 IMBALANCED DROPOUTS IN 10% dropout rate in active arm v. zero in control arm PHASE 2b UNKNOWN LO
Slide 45: A Potential TPIP Launch Is Many Years Away
45 TPIP MARKET - TIMELINE A Potential TPIP Launch Is Many Years Away APPROVAL AND LAUNCH, IF SUCCESSFUL, NOT EXPECTED UNTIL 2029-2030 7 Recent phase 3 exercise capacity Clinical outcomes studies take 6 studies in PH1 have taken a weighted even longer to conduct average of close to three years to run
Slide 46: What Could UTHR Look Like in 2030?
46 TPIP MARKET - TIMELINE What Could UTHR Look Like in 2030?1 ONCE-DAILY ORAL RALINEPAG Potentially paradigm-shifting in PAH, reducing the need for inhaled therapy ONCE-DAILY NCE2 INHALED Likely a similar timeline as TPIP PROSTACYCLIN NOVEL TYVASO DEVICES ON MARKET New devices could increase conveni
Slide 47: TPIP Faces a Challenging Path to Potential Approval
47 TPIP MARKET TPIP1 Faces a Challenging Path to Potential Approval NO NEAR-TERM MANY YEARS PATH TO MARKET FROM MARKET IN IPF2 UNPROVEN SAFETY 1. TPIP = treprostinil palmitil inhalation powder. 2. IPF = idiopathic pulmonary fibrosis.
Slide 48: Q&A
48 Q&A Dr. Martine Rothblatt Chairperson and Chief Executive Officer Michael Benkowitz President and Chief Operating Officer James Edgemond Chief Financial Officer and Treasurer Dr. Leigh Peterson EVP, Product Development and Xenotransplantation Patrick Poisson EVP, Technical Operations Dr. Gil Gold
Slide 49: Appendix
Appendix
Slide 50: Tyvaso TETON 1 and 2 Studies
50 INNOVATION Tyvaso TETON 1 and 2 Studies TETON 1 TETON 2 Indication Idiopathic pulmonary fibrosis U.S. Addressable Population 100,000 patients TETON 2 data expected 2H/25 Study Size 5983 5974 Study Geography U.S./Canada ROW1 TETON 1 data expected 1H/26 Change in absolute FVC2 from Primary Endpoint
Slide 51: Tyvaso TETON PPF Study
51 INNOVATION Tyvaso TETON PPF Study Indication Progressive pulmonary fibrosis Study Size 698 patients Currently Enrolling Study Geography Global Patients Change in absolute FVC1 from Primary Endpoint baseline to week 52 Enrollment Progress Currently enrolling 1. FVC = forced vital capacity, or the
Slide 52: Ralinepag ADVANCE OUTCOMES Study
52 INNOVATION Ralinepag ADVANCE OUTCOMES Study Indication Group 1 PAH1 Data expected in 20263 One pill, once a day, with a ~24-hour U.S. Addressable Population 50,000 patients half-life that can approximate IV prostacyclin blood levels4 Study Size ~700 patients Potential to develop a triple combo of
Slide 53: Ralinepag for PAH
53 INNOVATION DURABLE PVR IMPROVEMENT Ralinepag for PAH1,2 Phase 2 OLE3 data demonstrate long-term treatment with ralinepag produces durable and clinically-relevant responses for PVR4 and 6MWD6 with a manageable adverse event profile7 SUSTAINED 6MWD INCREASE In 24-month open-label data, a 52 dyn.s/c
Slide 54: Three Platforms with Four Organs & Organ Alternatives
OUR FUTURE 54 54 Three Platforms with Four Organs & Organ Alternatives XENOTRANSPLANTATION FIRST IND1 IND TRANSPLANT SUBMITTED EXPECTED SHORTLY EXTEND STUDY EXPRESS STUDY EXPAND STUDY UKidney UThymoKidney UHeart ALLOGENEIC REGENERATIVE MEDICINE PHASE 1 STUDY OPEN miroliverELAP2 mirokidney miroliver
Slide 55: Rapidly Progressing Toward a Revolution
REVOLUTION 55 55 Rapidly Progressing Toward a Revolution EXPAND UKIDNEY CLINCAL STUDY HIGHLIGHTS1 • ~50 patients: six in initial cohort; ~44 in expanded cohort • ESRD/dialysis patients age 55-70 • Ineligible for a kidney transplant or significantly waitlisted • Endpoints at 24 weeks: survival, funct
Slide 56: Tyvaso
56 COMMERCIAL EXECUTION Tyvaso W/W1 Combined Revenue▲18% y/y2 to $470M4 466 470 434 U.S. Combined Revenue ▲17% y/y to $455M4,5 398 416 • Most prescribed prostacyclin in the U.S.4 31% 3 351 373 US CAGR • Highest revenue quarter4 319 326 141 139 • Record patient shipments during the quarter4 145 136 2
Slide 57: Orenitram
57 COMMERCIAL EXECUTION Orenitram Quarterly revenue, millions USD Revenue▲16% y/y1 to $124M 11% 121 124 • Record patient shipments CAGR2 113 • Highest revenue quarter 106 107 108 95 • 14th sequential quarter of y/y quarterly 92 85 83 88 88 84 revenue growth 79 75 75 74 72 76 76 72 0 0 0 1 1 1 1 2 2
Slide 58: Remodulin
58 COMMERCIAL EXECUTION Remodulin Quarterly revenue, millions USD 147 140 138 W/W1 revenue ▼9% y/y2 to $135M 128 130 132 132 131 128 128 135 135 125 127 125 U.S. revenue ▼7% y/y to $114M 119 118 114 123 121 115 123 118 120 115 115 • Most prescribed U.S. parenteral prostacyclin 109 111 111 109 112 11
Slide 59: Unituxin
59 COMMERCIAL EXECUTION Unituxin Quarterly revenue, millions USD W/W1 revenue▲13% y/y2 to $58M 68 U.S. Unituxin ex-U.S. Unituxin U.S. revenue ▲18% y/y to $55M4 61 58 58 58 55 56 62 54 53 51 52 58 • The most prescribed antibody therapy 50 57 46 49 53 55 for high-risk neuroblastoma in the U.S. 44 45 4
Slide 60: Most prescribed U.S. prostacyclin; Record patient shipments; Highest revenue quarter
60 Most prescribed Most prescribed U.S. prostacyclin parenteral prostacyclin in the U.S. Record patient shipments Highest revenue quarter 19th consecutive quarter of y/y1 revenue growth The most prescribed 14th sequential quarter of antibody therapy for quarterly y/y revenue growth high-risk neurobl
Slide 61: Ics
Ics A PUBLIC BENEFIT CORPORATION Uni t=) 3 3a wo ® = a