United Therapeutics Corporation · NASDAQ:UTHR
United Therapeutics — Q3 2024 Earnings Presentation
32 slides from United Therapeutics's earnings presentation, Oct 30, 2024
Slide 1: United Therapeutics Corporation Third Quarter 2024 Corporate Update
United Therapeutics Corporation Third Quarter 2024 Corporate Update October 30, 2024
Slide 2: Safe Harbor Statement
2 INTRODUCTION Safe Harbor Statement All statements in this presentation are made as of October 30, 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 no
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 Events
5 INTRODUCTION Upcoming Investor Events UBS Global Healthcare Oppenheimer Movers in 43rd Annual J.P. Morgan Conference Rare Disease Summit Healthcare Conference November 11-14, 2024 December 12, 2024 January 13-16, 2025
Slide 6: Upcoming Medical Conferences
6 INTRODUCTION Upcoming Medical Conferences PHenomenal Hope 2024 PVRI 2025 Annual Congress December 6, 2024 January 29 – February 1, 2025
Slide 7: Dr. Martine Rothblatt
7 Dr. Martine Rothblatt CHAIRPERSON & CHIEF EXECUTIVE OFFICER
Slide 8: 3Q 2024 Performance Summary
8 3Q 2024 Performance Summary Product Product Revenue Percent Change1 $1.1 B Tyvaso DPI®/ Nebulized Tyvaso® $434 M 33% TTM Operating Cash Flow Remodulin® $128 M 2% $4.6 B Cash, Cash Equivalents, & Orenitram® $113 M 23% Marketable Investments Unituxin® $61 M 19% Highest Quarterly Tyvaso®3, 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 $2B Today Future 1. Illustrative purposes only. Time
Slide 10: Development Engine Addressing Unmet Needs
10 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 Organs and O
Slide 11: Tyvaso TETON 1 and 2 Studies
11 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 TETON 1 Targeted Study Size 576 5975 for Year-End 20244 Study Geography U.S./Canada ROW1 TETON 2 Fully Enrolled Change in absolute
Slide 12: Tyvaso TETON PPF Study
12 INNOVATION Tyvaso® TETON PPF Study Indication Progressive pulmonary fibrosis U.S. Addressable Population 60,000 patients1,2,3 Currently Enrolling Study Size 698 patients Patients Study Geography Global Change in absolute FVC4 from Primary Endpoint baseline to week 52 Enrollment Progress Currently
Slide 13: Tyvaso for IPF
13 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 14: Ralinepag ADVANCE OUTCOMES Study
14 INNOVATION Ralinepag ADVANCE OUTCOMES Study Indication Group 1 PAH1 Data expected in 20263 U.S. Addressable Population 50,000 patients One pill, once a day, with a ~24-hour half-life that can approximate IV Study Size ~700 to 1,000 patients prostacyclin blood levels4 Study Geography Global Time f
Slide 15: Ralinepag for PAH
15 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 16: Ex-Vivo Lung Perfusion
16 INNOVATION Ex-Vivo Lung Perfusion • More than 830 lung evaluations, resulting in over 500 successful transplants1 • Lungs transplanted through EVLP2 would have otherwise been discarded • Two methods used: • XPS3: Third-party supplied EVLP device • CLES4: Internally-developed device with potential
Slide 17: Four Platforms with Four Organs and Organ Alternatives
REVOLUTION 17 Four Platforms with Four Organs and Organ Alternatives; 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 U
Slide 18: miroliverELAP: First Bioengineered Organ Alternative in Human Trials
18 REVOLUTION miroliverELAP®: the First Bioengineered Organ Alternative to Enter Human Clinical Trials • External liver assist product (ELAP) intended to provide liver support in the critical care setting • Acute liver failure is a devastating condition with no approved drug or medical device interv
Slide 19: Xenotransplants March Toward the Clinic
REVOLUTION 19 Xenotransplants March Toward the Clinic IND EXPECTED SHORTLY DPF2 OPERATIONS Pre-IND1 feedback received; expect to file Christiansburg, VA: Operational an IND shortly for UKidney™ 10-gene 125 organ annual capacity; $75 million investment edited xenokidney Stewartville, MN: Under constr
Slide 20: Xenotransplants March Toward the Clinic
REVOLUTION 20 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 21: Foundation, Innovation, Revolution
21 FOUNDATION INNOVATION REVOLUTION Tyvaso DPI® Tyvaso DPI Xenotransplantation Nebulized Tyvaso® Nebulized Tyvaso Regenerative Medicine Orenitram® Ralinepag 3D Organ Alternative Remodulin® EVLP5 Printing Unituxin® Bio-Artificial Organ PAH Alternatives PAH1 PH-ILD PH-ILD2 IPF3 XENO AND PPF4 ORGAN ALT
Slide 22: James Edgemond
22 James Edgemond CHIEF FINANCIAL OFFICER & TREASURER
Slide 23: Commitment to Balanced Capital Allocation; Accelerated Share Repurchase Complete
23 CAPITAL ALLOCATION Commitment to Balanced Capital Allocation; Accelerated Share Repurchase Complete PRIORITY 1 COMMERCIAL/R&D $1 billion ASR1 completed in 3Q, INVESTMENT reducing outstanding UTHR shares by approximately 7%2 ~3.5 Multi-tranche program resulted in MILLION PRIORITY 2 CORPORATE retir
Slide 24: Michael Benkowitz
24 Michael Benkowitz PRESIDENT & CHIEF OPERATING OFFICER
Slide 25: Continued Strong Revenue Growth in 3Q/24
25 COMMERCIAL EXECUTION Continued Strong Revenue Growth in 3Q/24 Quarterly revenue, millions USD Tyvaso3, worldwide 700 ▲ 33% y/y1 to $434M 600 13% Remodulin, worldwide 500 CAGR2 ▼ 2% y/y to $128M 400 Orenitram ▲ 23% y/y to $113M 300 200 Unituxin, worldwide ▲ 19% y/y to $61M 100 Total Revenue 0 ▲ 23
Slide 26: Tyvaso
26 COMMERCIAL EXECUTION Tyvaso® 434 W/W1 Combined Revenue▲33% y/y2 to $434M4 398 373 U.S. Combined Revenue ▲30% y/y to $420M4,6 351 319 326 145 • Most prescribed prostacyclin in the U.S.4 31% 130 • Highest revenue quarter ever 4 US CAGR3 258 124 134 • No material inventory changes q/q 4,5 242 238 12
Slide 27: Orenitram
27 COMMERCIAL EXECUTION Orenitram® Quarterly revenue, millions USD Revenue▲23% y/y1 to $113M 13% 106 107 113 CAGR2 • Highest revenue quarter 92 85 88 88 95 84 • 11th sequential quarter of y/y quarterly 83 75 75 74 76 79 76 revenue growth 72 72 62 69 51 9 9 0 0 0 0 1 1 1 1 2 2 2 2 3 3 3 3 4 4 4 /1 /1
Slide 28: Remodulin
28 COMMERCIAL EXECUTION Remodulin® 168 Quarterly revenue, millions USD 145 147 W/W1 revenue ▼2% y/y2 to $128M 140 132 132 131 128 130 U.S. revenue ▲3% y/y to $115M 119 125 125 118 123 121 127 128 128 127 114 115 107 123 • Most prescribed U.S. parenteral prostacyclin 117 115 115 111 111 112 • Highest
Slide 29: Unituxin
29 COMMERCIAL EXECUTION Unituxin® Quarterly revenue, millions USD W/W1 revenue▲19% y/y2 to $61M U.S. Unituxin ex-U.S. Unituxin 58 61 U.S. revenue ▲18% y/y to $58M4 55 56 53 54 51 52 58 50 49 53 • Record total and U.S. revenue 46 44 45 44 49 48 48 49 45 44 47 • The most prescribed antibody therapy 38
Slide 30: Record revenue across products
30 Most prescribed Most prescribed U.S. prostacyclin parenteral prostacyclin in the U.S. Record revenue Highest number of patients on therapy Record total revenue th 16 consecutive quarter of y/y1 revenue growth Record revenue 11th sequential quarter of The most prescribed quarterly y/y revenue grow
Slide 31: Q&A
31 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 32: United Therapeutics: A Public Benefit Corporation
Therapeutics A PUBLIC BENEFIT CORPORATION x) o = iS =)