United Therapeutics Corporation · NASDAQ:UTHR
United Therapeutics — Q1 2024 Earnings Presentation
31 slides from United Therapeutics's earnings presentation, May 1, 2024
Slide 1: First Quarter 2024 Financial Update
United Therapeutics Corporation First Quarter 2024 Financial Update May 1, 2024
Slide 2: Safe Harbor Statement
2 INTRODUCTION Safe Harbor Statement All statements in this presentation are made as of May 1, 2024. 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 not his
Slide 3: Today's Speakers
3 INTRODUCTION Today’s Speakers Dr. Martine Rothblatt Michael Benkowitz James Edgemond Chairperson & Chief Executive Officer President & Chief Operating Officer Chief Financial Officer & Treasurer
Slide 4: Other Executives Present Today
4 INTRODUCTION Other Executives Present Today Dr. Leigh Peterson Pat Poisson Executive Vice President, Executive Vice President, Product Development & Technical Operations Xenotransplantation
Slide 5: Upcoming Investor Event
5 INTRODUCTION Upcoming Investor Event 45th Annual Goldman Sachs Global Healthcare Conference Wednesday, June 12, 2024
Slide 6: Upcoming Medical Conferences
6 INTRODUCTION Upcoming Medical Conferences American Thoracic Society Seventh World PHA 2024 International (ATS) International Symposium on PH Conference and Conference 2024 Pulmonary Hypertension Scientific Sessions May 17-22, 2024 June 29 - July 1, 2024 August 15-18, 2024
Slide 7: James Edgemond
7 James Edgemond CHIEF FINANCIAL OFFICER & TREASURER
Slide 8: ASR Demonstrates Our Commitment to Balanced Capital Allocation
8 FOUNDATION ASR1 Demonstrates Our Commitment to Balanced Capital Allocation • Decision supported by shareholder feedback $1 billion • Ample remaining capital to meet mid- and long-term goals 3.3 million • Continued belief in our core share business and cash flow potential reduction • ASR represents
Slide 9: Dr. Martine Rothblatt
9 Dr. Martine Rothblatt CHAIRPERSON & CHIEF EXECUTIVE OFFICER
Slide 10: 1Q 2024 Performance Summary
10 1Q 2024 Performance Summary Product Product Revenue Percent Change1 $980 M Tyvaso DPI®/ Nebulized Tyvaso® $373 M 56% TTM Operating Cash Flow Remodulin® $128 M 5% $4.2 B Cash, Cash Equivalents, & Orenitram® $106 M 20% Marketable Investments Unituxin® $58 M 19% Highest Quarterly Revenue for Tyvaso®
Slide 11: Positioned for Multiple Waves of Growth
11 HOW WE OPERATE Positioned for Multiple Waves of Growth1 Revenue $16B REVOLUTION Organ Manufacturing $8B INNOVATION Tyvaso IPF/PPF & Ralinepag PAH $4B FOUNDATION Current Commercial Portfolio $2B Today Future 1. Illustrative purposes only. Time
Slide 12: Development Engine Addressing Unmet Needs
12 01 INNOVATION Development Engine Addressing Unmet Needs NON-REGISTRATION REGISTRATION APPROVED Tyvaso® TETON 1 – Idiopathic Pulmonary Fibrosis – U.S. and Canada TETON 2 – Idiopathic Pulmonary Fibrosis – ROW1 TETON PPF – Progressive Pulmonary Fibrosis Ralinepag ADVANCE OUTCOMES – PAH2 Organ Manufa
Slide 13: Tyvaso TETON 1 and 2 Studies
13 INNOVATION Tyvaso® TETON 1 and 2 Studies TETON 1 TETON 2 Indication Idiopathic pulmonary fibrosis U.S. Addressable Population 100,000 patients Complete Enrollment for Both Studies Targeted Study Size 576 576 for Year-End 20244 Study Geography U.S./Canada ROW1 Updated TETON baseline data to be pre
Slide 14: Tyvaso TETON PPF Study
14 INNOVATION Tyvaso® TETON PPF Study Indication Progressive pulmonary fibrosis U.S. Addressable Population 60,000 patients1,2,3 First Patient Enrolled Study Size 698 patients in October 2023 Study Geography Global Change in absolute FVC4 from Primary Endpoint baseline to week 52 Enrollment Progress
Slide 15: Tyvaso for IPF
15 INNOVATION 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 subgroup showed meaningful and sustained FVC improvement, including when placebo patients were crossed over in t
Slide 16: Ralinepag ADVANCE OUTCOMES Study
16 INNOVATION Ralinepag ADVANCE OUTCOMES Study Indication Group 1 PAH1 Trial Completion Targeted in 20263 U.S. Addressable Population 50,000 patients One pill, once a day, with a ~24-hour Study Size ~700 to 1,000 patients half-life that can approximate IV prostacyclin blood levels4 Study Geography G
Slide 17: Ralinepag for PAH
17 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 18: Ex-Vivo Lung Perfusion
18 INNOVATION Ex-Vivo Lung Perfusion • More than 700 lung evaluations, resulting in 440 successful transplants1 • Lungs transplanted through EVLP2 would have otherwise been discarded • Two methods used: • XPS3: Third-party suppled EVLP device • CLES4: Internally-developed device with a potentially b
Slide 19: Four Platforms with Four Organs; Multiple Shots on Goal
REVOLUTION 19 Four Platforms with Four Organs; Multiple Shots on Goal 1. 3DAP = 3D autologous printed. 2. Bio-Art = Bioartificial. 3. ELAP = external liver assist product. Xeno Regen Med 3DAP1 Bio-Art2 Kidney UKidney™ IVIVA Kidney UThymoKidney™ mirokidney® Heart UHeart™ Lung ULobe™ ULung™ miroliverE
Slide 20: Xenotransplants March Toward the Clinic
REVOLUTION 20 Xenotransplants March Toward the Clinic CLINICAL DPF NOW OPERATIONAL NYU TRANSPLANT First transplant of a xenothymokidney into a living recipient First combined mechanical heart pump and organ transplant First xenotransplant into a living human using 125-organ annual capacity FDA-appro
Slide 21: Xenotransplants March Toward the Clinic
REVOLUTION 21 Xenotransplants March Toward the Clinic XENO REVIEW MANUSCRIPT 10-GENE PRECLINICAL MANUSCRIPT First comprehensive review publication on First documented use of standard, FDA- xenotransplantation approved, immunosuppression with long-term survival in preclinical xenotransplantation Deta
Slide 22: Foundation, Innovation, Revolution
22 FOUNDATION INNOVATION REVOLUTION Tyvaso DPI® Tyvaso DPI Xenotransplantation Nebulized Tyvaso® Nebulized Tyvaso Regenerative Medicine Orenitram® Ralinepag 3D Organ Printing Remodulin® EVLP5 Bio-Artificial Organs Unituxin® PAH ORGAN PAH1 PH-ILD MANUFACTURING PH-ILD2 IPF3 PPF4 LUNG TRANSPLANT 1. PAH
Slide 23: Michael Benkowitz
23 Michael Benkowitz PRESIDENT & CHIEF OPERATING OFFICER
Slide 24: Continued Strong Revenue Growth in 1Q/24
24 COMMERCIAL EXECUTION Continued Strong Revenue Growth in 1Q/24 Quarterly revenue, millions USD 700 Tyvaso3, worldwide Tyvas o Remodulin Orenitram Unituxin Adcirca/Other ▲ 56% y/y1 to $373M 600 13% Remodulin, worldwide CAGR2 500 ▲ 5% y/y to $128M 400 Orenitram ▲ 20% y/y to $106M 300 Unituxin, world
Slide 25: Tyvaso
25 COMMERCIAL EXECUTION Tyvaso® 351 373 W/W1 Combined Revenue▲56% y/y2 to $373M4 319 326 U.S. Combined Revenue ▲54% y/y to $361M4 134 • Most prescribed prostacyclin in the U.S.4 29% 258 242 238 120 118 124 US CAGR3 • Highest revenue quarter ever 4 201 • Highest referrals and starts4 • No material in
Slide 26: Orenitram
26 COMMERCIAL EXECUTION Orenitram® Quarterly revenue, millions USD Revenue▲20% y/y1 to $106M 106 • Highest revenue quarter 13% 88 95 92 • Ninth sequential quarter of y/y CAGR2 88 85 83 84 quarterly revenue growth 79 75 75 74 76 76 72 72 69 62 58 54 51 1Q/19 2Q/19 3Q/19 4Q/19 1Q/20 2Q/20 3Q/20 4Q/20
Slide 27: Remodulin
27 COMMERCIAL EXECUTION Remodulin® 168 Quarterly revenue, millions USD 156 156 W/W1 revenue ▲5% y/y2 to $128M 145 140 132 132 U.S. revenue ▲16% y/y to $108M 125 128 130 125 123 121 127 131 128 119 118 127 114 115 123 123 107 • Most prescribed U.S. parenteral prostacyclin 117 115 112 • Near-record re
Slide 28: Unituxin
28 COMMERCIAL EXECUTION Unituxin® 58 Quarterly revenue, millions USD 55 56 54 W/W1 revenue▲19% y/y2 to $58M 53 50 49 51 U.S. revenue ▲21% y/y to $53M4 53 46 44 45 44 48 48 49 49 45 • Highest revenue quarter 38 43 43 37 44 43 42 • The most prescribed antibody therapy 34 40 30 37 30 36 for high-risk n
Slide 29: Product revenue highlights
29 Most prescribed U.S. prostacyclin Most prescribed Highest revenue quarter ever parenteral prostacyclin in the U.S. Highest level of referrals and starts Near-record referrals and starts Record total revenue th 14 consecutive quarter of y/y1 revenue growth The most prescribed Ninth sequential quar
Slide 30: Q&A
30 Q&A Dr. Martine Rothblatt Chairperson & Chief Executive Officer Michael Benkowitz President & Chief Operating Officer James Edgemond Chief Financial Officer & Treasurer Dr. Leigh Peterson EVP, Product Development & Xenotransplantation Patrick Poisson EVP, Technical Operations Dewey Steadman Head
Slide 31: Therapeutics
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