United Therapeutics Corporation · NASDAQ:UTHR
United Therapeutics — Q3 2023 Earnings Presentation
31 slides from United Therapeutics's earnings presentation, Nov 1, 2023
Slide 1: Third Quarter 2023 Financial Update
United Therapeutics Corporation Third Quarter 2023 Financial Update November 1, 2023
Slide 2: Safe Harbor Statement
2 INTRODUCTION Safe Harbor Statement All statements in this presentation are made as of November 1, 2023. 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 & Chief Executive Officer President & Chief Operating Officer UTHR: A Public Benefit Corporation
Slide 4: Other Executives Present Today
4 INTRODUCTION Other Executives Present Today James Edgemond Dr. Leigh Peterson Pat Poisson Chief Financial Officer & Treasurer Executive Vice President, Executive Vice President, Product Development & Technical Operations Xenotransplantation UTHR: A Public Benefit Corporation
Slide 5: Upcoming Investor Events
5 INTRODUCTION Upcoming Investor Events UBS Biopharma Conference J.P. Morgan Healthcare Conference Wednesday, November 8, 2023 Monday, January 8 – Thursday, January 11, 2024 UTHR: A Public Benefit Corporation
Slide 6: Dr. Martine Rothblatt
6 Dr. Martine Rothblatt CHAIRPERSON & CHIEF EXECUTIVE OFFICER UTHR: A Public Benefit Corporation
Slide 7: 3Q 2023 Performance Summary
7 3Q 2023 Performance Summary Product Product Revenue Percent Change1 $956 M Tyvaso DPI®/ Nebulized Tyvaso® $326 M 26% TTM Operating Cash Flow Remodulin® $131 M 15% $4.9 B Cash, Cash Equivalents, & Orenitram® $92 M 5% Marketable Investments Unituxin® $51 M 11% Highest Patient Count For Tyvaso franch
Slide 8: Positioned for Multiple Waves of Growth
8 INNOVATION Positioned for Multiple Waves of Growth1 Revenue $16B Wave 3 Organ Manufacturing $8B Wave 2 Tyvaso IPF/PPF & Ralinepag PAH $4B Wave 1 Current Commercial Portfolio $2B Today Future 1. Illustrative purposes only. Time UTHR: A Public Benefit Corporation
Slide 9: Development Engine Addressing Unmet Needs
9 01 INNOVATION Development Engine Addressing Unmet Needs PRECLINICAL NON-REGISTRATION REGISTRATION APPROVED Tyvaso® TETON 1 TETON 2 TETON PPF Ralinepag ADVANCE OUTCOMES Organ Manufacturing EVLP2/CLES2 UHeart™ UKidney™ ULobe™ ULung™ UThymoKidney™ 3D-Printed Kidney 1. EVLP = ex-vivo lung perfusion; 3
Slide 10: Tyvaso TETON 1 and 2 Studies
10 INNOVATION Tyvaso® TETON 1 and 2 Studies TETON 1 TETON 2 Indication Idiopathic pulmonary fibrosis Complete Enrollment for U.S. Addressable Population 100,000 patients Both Studies Targeted for Year-End 20244 Study Size 576 576 DSMC5 recommended continuation of Study Geography U.S./Canada ROW1 bot
Slide 11: Tyvaso TETON PPF Study
11 INNOVATION Tyvaso® TETON PPF Study Indication Progressive pulmonary fibrosis U.S. Addressable Population 60,000 patients First Patient Enrolled Study Size 698 patients in October 2023 Study Geography Global Change in absolute FVC1 from Primary Endpoint baseline to week 52 Enrollment Progress Firs
Slide 12: Tyvaso for IPF
12 INNOVATION Tyvaso for IPF1,2 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 the open-label extension 1. IPF = idiop
Slide 13: Ralinepag ADVANCE OUTCOMES Study
13 INNOVATION Ralinepag ADVANCE OUTCOMES Study Indication Group 1 PAH1 Trial Completion U.S. Addressable Population 50,000 patients Targeted in 20253 DSMC4 recommended continuation Study Size ~700 to 1,000 patients of both studies after an unblinded safety review of 510 patients Study Geography Glob
Slide 14: Organ Manufacturing Efforts
14 INNOVATION Organ Manufacturing Efforts OUR GOAL: An unlimited supply of tolerable, transplantable organs to address end stage organ disease
Slide 15: IVIVA Medical
15 INNOVATION IVIVA Medical • Mimics native kidney elements with a simple architecture • Uses a patient’s own cells, eliminating the need for immunosuppression • Based in Woburn, MA; 16 employees joined United Therapeutics • $50 million acquisition closed in October; 2% royalty on any commercial sal
Slide 16: Xenotransplantation
16 INNOVATION Xenotransplantation Pre-clinical progress • ”Pivotal” pre-clinical studies underway • Last xenokidney transplant expected early 2024 • FDA meeting to discuss IND and clinical protocol for 10-gene xeno-organs Designated Pathogen Free Facility (DPF) • ~$75 million investment in Christian
Slide 17: Regenerative Medicine and 3D Organ Printing
17 INNOVATION Regenerative Medicine and 3D Organ Printing ULobe™ Regenerative Lung ULung™ 3D-Printed Lung ULobe is a development-stage engineered lung generated with a ULung is a development-stage personalized lung composed of a porcine lung scaffold and human allogeneic lung cells 3D printed lung s
Slide 18: Wave 1, Wave 2, Wave 3
18 WAVE 1 WAVE 2 WAVE 3 Tyvaso DPI® Tyvaso DPI UHeart™ Nebulized Tyvaso® Nebulized Tyvaso ULobe™ Orenitram® Ralinepag UKidney™ Remodulin® ULung™ Unituxin® PAH UThymoKidney™ PH-ILD 3DAP5 Kidney PAH1 IPF3 PH-ILD2 PPF4 ORGAN MANUFACTURING 1. PAH = pulmonary arterial hypertension; 2. PH-ILD = pulmonary
Slide 19: Michael Benkowitz
19 Michael Benkowitz PRESIDENT & CHIEF OPERATING OFFICER UTHR: A Public Benefit Corporation
Slide 20: Continued Strong Revenue Growth in 3Q/23
20 COMMERCIAL EXECUTION Continued Strong Revenue Growth in 3Q/23 600 Tyvaso Tyvaso Remodulin Orenitram Unituxin Adcirca Other ▲26% y/y1 to $326M 500 11% CAGR2 Remodulin 400 ▲15% y/y to $131M 300 Orenitram ▲5% y/y to $92M 200 Unituxin 100 ▲11% y/y to $51M 0 Total Revenue 8 8 8 8 9 9 9 9 0 0 0 0 1 1 1
Slide 21: Orenitram
21 COMMERCIAL EXECUTION Orenitram® Quarterly revenue, millions USD 95 92 Revenue▲5% y/y1 to $92M 88 88 85 83 79 • Second-highest revenue quarter 75 75 74 76 76 72 72 ever 11% 69 58 62 CAGR2 • Seventh sequential quarter of y/y 52 50 54 50 54 51 quarterly revenue growth 8 8 8 8 9 9 9 9 0 0 0 0 1 1 1 1
Slide 22: Remodulin
22 COMMERCIAL EXECUTION Quarterly revenue, millions USD Remodulin® 160 159 168 154 156 156 Revenue▲15% y/y1 to $131M 145 140 2% 132 132 CAGR2 131 127 128 130 127 125 125 123 121 • Most prescribed parenteral 119 118 114 prostacyclin in the U.S. 107 • Near record level of patient referrals Generic SQ4
Slide 23: Unituxin
23 COMMERCIAL EXECUTION Unituxin® 55 56 Revenue▲11% y/y1 to $51M Quarterly revenue, millions USD 53 51 50 46 49 • The first antibody therapy FDA- 44 45 44 approved for children with high-risk 18% 38 37 neuroblastoma CAGR2 34 30 30 • The most prescribed antibody 29 27 therapy for high-risk neuroblast
Slide 24: Tyvaso
24 COMMERCIAL EXECUTION Tyvaso® Tyvaso DPI Nebulized Tyvaso 319 326 Revenue▲26% y/y1 to $326M 258 • Most prescribed prostacyclin in the U.S. 242 238 25% • Highest revenue quarter ever CAGR2 201 • Highest number of patients on therapy, 172 164 167 patient referrals, and patient starts 154 130 132 119
Slide 25: MannKind Manufacturing Expansion
25 COMMERCIAL EXECUTION MannKind Manufacturing Expansion • First phase of process improvements and new equipment installations complete • Increased supply led to fulfillment improvements in 3Q • Second phase, including installation of a high-speed filling line, expected to be complete in 1H/2024 New
Slide 26: PH-ILD Field Force Expansion
26 COMMERCIAL EXECUTION PH-ILD Field Force Expansion Regional Nurse Specialists Reimbursement Specialists Medical Science Liaisons Sales Representatives
Slide 27: Nebulized Tyvaso
27 COMMERCIAL EXECUTION Nebulized Tyvaso® Nebulized Tyvaso Remains an Important, Differentiated Option • Platform of nebulized Tyvaso and Tyvaso DPI® gives physicians and patients the option to choose the format that’s right for them • Precise titration in one-breath increments before transitioning
Slide 28: United Therapeutics
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Slide 29: Third quarter commercial highlights by product
29 Most prescribed U.S. prostacyclin Most prescribed Highest revenue quarter ever parenteral prostacyclin in the U.S. Highest patients on therapy, Near record patient referrals, and patient starts level of patient referrals Record total revenue th 12 consecutive quarter of double-digit revenue growt
Slide 30: Q&A
30 Q&A Dr. Martine Rothblatt Chairperson & Chief Executive Officer Michael Benkowitz President & Chief Operating Officer Dr. Leigh Peterson EVP, Product Development & Xenotransplantation Patrick Poisson EVP, Technical Operations James Edgemond Chief Financial Officer & Treasurer Dewey Steadman Head
Slide 31: United Therapeutics
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