United Therapeutics Corporation · NASDAQ:UTHR
United Therapeutics — Q4 2023 Earnings Presentation
34 slides from United Therapeutics's earnings presentation, Feb 21, 2024
Slide 1: Fourth Quarter 2023 Financial Update
United Therapeutics Corporation Fourth Quarter 2023 Financial Update February 21, 2024
Slide 2: Safe Harbor Statement
2 INTRODUCTION Safe Harbor Statement All statements in this presentation are made as of February 21, 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 n
Slide 3: Today's Speakers
3 INTRODUCTION Today’s Speakers Dr. Martine Rothblatt Michael Benkowitz Chairperson & Chief Executive Officer President & Chief Operating Officer
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
Slide 5: Upcoming Investor Events
5 INTRODUCTION Upcoming Investor Events UBS European TD Cowen 44th Annual Leerink Partners Global Healthcare Conference Health Care Conference Biopharma Conference Tuesday, February 27, 2024 Tuesday, March 5, 2024 Tuesday, March 12, 2024
Slide 6: Upcoming Medical Conferences
6 INTRODUCTION Upcoming Medical Conferences American College of International Society for American Thoracic Society Cardiology (ACC) 73rd Heart & Lung (ATS) International Scientific Session Transplantation (ISHLT) Conference 2024 April 6-8, 2024 April 10-13, 2024 May 17-22, 2024
Slide 7: Dr. Martine Rothblatt
7 Dr. Martine Rothblatt CHAIRPERSON & CHIEF EXECUTIVE OFFICER
Slide 8: 4Q 2023 Performance Summary
8 4Q 2023 Performance Summary Product Product Revenue Percent Change1 $978 M Tyvaso DPI®/ Nebulized Tyvaso® $351 M 45% FY 23 Operating Cash Flow Remodulin® $115 M 6% $4.9 B Cash, Cash Equivalents, & Orenitram® $84 M 11% Marketable Investments Unituxin® $54 M 48% Highest Revenue for Tyvaso® Other + A
Slide 9: External Validation for Tyvaso DPI
9 HOW WE OPERATE External Validation for Tyvaso DPI® Sagard Healthcare Partners Acquired 1% Royalty Interest in Tyvaso DPI® from MannKind for $150 million + other milestones UTHR MARKET CAP AS OF FEBRUARY 11: ~$10 BILLION IMPLIED TYVASO DPI® REVENUE VALUATION OF $15 BILLION+ DEAL EXECUTED AFTER APPE
Slide 10: Positioned for Multiple Waves of Growth
10 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 11: Development Engine Addressing Unmet Needs
11 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 12: Tyvaso TETON 1 and 2 Studies
12 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 Study Size 576 576 Both Studies Targeted Study Geography U.S./Canada ROW1 for Year-End 20244 Change in absolute FVC2 from Primary
Slide 13: Tyvaso TETON PPF Study
13 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 14: Tyvaso for IPF
14 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 15: Ralinepag ADVANCE OUTCOMES Study
15 INNOVATION Ralinepag ADVANCE OUTCOMES Study Indication Group 1 PAH1 Trial Completion U.S. Addressable Population 50,000 patients Targeted in 20253 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 16: Ralinepag for PAH
16 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 6MWD5 with a manageable adverse event profile6 In 24-month open-label data, a 52 dyn.s/cm5 SUSTAINED 6MWD INCREA
Slide 17: Four Platforms with Four Organs; Multiple Shots on Goal
REVOLUTION 17 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 18: Xenotransplants March Toward the Clinic
18 REVOLUTION Xenotransplants March Toward the Clinic Pre-clinical progress • ”Pivotal” pre-clinical studies underway • Last pivotal non-clinical xenokidney transplant expected mid-24 • Upcoming FDA meetings to discuss IND and clinical protocol for 10-gene UKidney™ Designated Pathogen Free Facility
Slide 19: miroliverELAP: First Bioengineered Organ to Enter Human Clinical Trials
19 REVOLUTION miroliverELAP®: the First Bioengineered Organ 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 interventions: 30%
Slide 20: Foundation, Innovation, Revolution
20 FOUNDATION INNOVATION REVOLUTION Tyvaso DPI® Tyvaso DPI Xenotransplantation Nebulized Tyvaso® Nebulized Tyvaso Regenerative Medicine Orenitram® Ralinepag 3D Organ Printing Remodulin® Bio-Artificial Organs Unituxin® PAH PH-ILD ORGAN PAH1 IPF3 MANUFACTURING PH-ILD2 PPF4 1. PAH = pulmonary arterial
Slide 21: Michael Benkowitz
21 Michael Benkowitz PRESIDENT & CHIEF OPERATING OFFICER
Slide 22: Continued Strong Revenue Growth in 4Q/23
22 COMMERCIAL EXECUTION Continued Strong Revenue Growth in 4Q/23 Quarterly revenue, millions USD Tyvaso, worldwide 700 Tyvaso Remodulin Orenitram Unituxin Adcirca/Other ▲45% y/y1 to $351M 600 Remodulin, worldwide ▼6% y/y to $115M 500 10% CAGR2 Orenitram 400 ▲11% y/y to $84M 300 Unituxin, worldwide ▲
Slide 23: Orenitram
23 COMMERCIAL EXECUTION Orenitram® Quarterly revenue, millions USD 95 92 Revenue▲11% y/y1 to $84M 88 88 85 84 83 76 79 76 • Eighth sequential quarter of y/y 75 75 74 69 72 72 quarterly revenue growth 58 62 11% 54 54 CAGR2 52 51 50 50 1Q/18 2Q/18 3Q/18 4Q/18 1Q/19 2Q/19 3Q/19 4Q/19 1Q/20 2Q/20 3Q/20
Slide 24: Remodulin
24 COMMERCIAL EXECUTION U.S. Remodulin ex-U.S. Remodulin 168 Remodulin® 160 154 159 156 156 Quarterly revenue, millions USD 145 140 W/W1 revenue ▼6% y/y2 to $115M 132 132 131 127 138 128 130 127 125 U.S. revenue ▲9% y/y to $106M6 131 130 119 125 118 123 121 127 114 115 123 123 107 117 • Most prescri
Slide 25: Unituxin
25 COMMERCIAL EXECUTION Unituxin® Quarterly revenue, millions USD 53 55 56 54 W/W1 revenue▲48% y/y2 to $54M 50 49 51 U.S. revenue ▲34% y/y to $49M4 46 44 48 45 44 49 49 48 45 44 • Soft comparable prior-year quarter 38 43 42 43 43 37 34 40 • The most prescribed antibody therapy 37 30 34 29 30 15% 36
Slide 26: Tyvaso
26 COMMERCIAL EXECUTION Tyvaso® Tyvaso DPI U.S. Nebulized Tyvaso ex-U.S. Nebulized Tyvaso 351 W/W1 Revenue▲45% y/y2 to $351M 319 326 U.S. Revenue ▲40% y/y to $337M 124 • Most prescribed prostacyclin in the U.S. 258 242 238 120 118 • Highest revenue quarter ever 26% US CAGR3 201 • No material invento
Slide 27: Nebulized Tyvaso
27 COMMERCIAL EXECUTION Nebulized Tyvaso® SEQUENTIAL PATIENT GROWTH FROM 3Q/23 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-br
Slide 28: Tyvaso DPI: First and Only DPI Tailored for Distal Lungs
28 COMMERCIAL EXECUTION Tyvaso DPI®: The first and only DPI tailored for drug delivery to the distal lungs for PH1 ONE BREATH per cartridge2 DEEP LUNG delivery1 NO CLEANING required3 ROOM TEMP patient storage5 NO MAX labeled dose4 HIGH PATIENT satisfaction6 1. Colleen McEvoy, et al. Tyvaso DPI: Drug
Slide 29: We've Been Here Before…
29 COMMERCIAL EXECUTION We’ve Been Here Before… FOUR PATHWAYS INVOLVED IN PAH POLYTHERAPY IS NORM PAH is a complex, multifactorial disease with Polytherapy is the standard of care multiple pathways1 for PAH treatment2 1. N Engl J Med 2021; 384:1204-1215 DOI: 10.1056/NEJMoa2024277. 2. Burks M, Sticke
Slide 30: We've Been Here Before… PH-ILD
30 COMMERCIAL EXECUTION We’ve Been Here Before… NOT CURATIVE BROAD PCY3 USE STUDIED IN PAH ONLY PH-ILD In the phase 3 study, Activin signaling inhibitors No Group 3 PH-ILD patients 70% were on background PCY are not a cure for PAH1 were in the phase 3 study1 and 40% on parenteral PCY1 1. N Engl J Me
Slide 31: Deep Clinical Experience With Treprostinil
31 COMMERCIAL EXECUTION Deep Clinical Experience With Treprostinil Ensures a Place in the Treatment Paradigm USE EXPERIENCE DOSE RESPONSE HEMODYNAMICS BLOOD TESTING Two decades of Correlation Improvement No regular use and safety between dose and across a blood testing data1-4 outcomes5 wide array o
Slide 32: Most Prescribed U.S. Prostacyclin, Highest Revenue Quarter Ever
32 Most prescribed U.S. prostacyclin Most prescribed Highest revenue quarter ever parenteral prostacyclin in the U.S. Record total revenue th 13 consecutive quarter of double-digit revenue growth1 The most prescribed Eighth sequential quarter of antibody therapy for quarterly y/y1 revenue growth hig
Slide 33: Q&A
33 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 34: Therapeutics
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