Theravance Biopharma, Inc. · NASDAQ:TBPH
Theravance Biopharma — Investor Presentation (January 2020)
34 slides from Theravance Biopharma's investor presentation, Jan 13, 2020
Slide 1: Corporate Presentation January 2020
Corporate Presentation January 2020 THERAVANCE ® , the Cross/Star logo and MEDICINES THAT MAKE A DIFFERENCE® are registered trademarks of the Theravance Biopharma group of companies. All third party trademarks used herein are the property of their respective owners. © 2020 Theravance Biopharma. All
Slide 2: Forward looking statements
Forward looking statements 2 Under the safe harbor provisions of the U . S . Private Securities Litigation Reform Act of 1995 , the company cautions investors that any forward - looking statements or projections made by the company are subject to risks and uncertainties that may cause actual results
Slide 3: Strategic objective
Strategic objective 3 Transform the treatment of serious diseases through the discovery, development, and commercialization of organ - selective medicines designed to maximize patient benefit while minimizing patient risk
Slide 4: Creating transformational value for stakeholders
Creating transformational value for stakeholders 1. TBPH holds 85% economic interest in upward - tiering royalty stream of 6.5% – 10% payable by GSK (net of TRC expenses paid and the amount of cash, if any, expected to be used by TRC pursuant to the TRC Agreement over the next four fiscal quarters).
Slide 5: Key programs supported by proven development and commercial expertise
Program Indication Research Phase 1 Phase 2 Phase 3 Filed Marketed Collaborator Organ - selective YUPELRI® (revefenacin) LAMA COPD TD - 1473 GI JAKi UC CD TD - 8236 Inhaled JAKi Inflammatory lung diseases Wholly - owned TD - 5202 Irreversible JAK3i Inflammatory intestinal diseases New programs Multi
Slide 6: Economic interest in GSK's TRELEGY ELLIPTA
Economic interest GSK’s TRELEGY ELLIPTA (FF/UMEC/VI): First and only once - daily single inhaler triple therapy
Slide 7: Economic interest in GSK's TRELEGY ELLIPTA
Economic interest in GSK’s TRELEGY ELLIPTA UPWARD - TIERING ROYALTIES OF ~5.5% TO 8.5% OF WORLDWIDE NET SALES 1 Strongest US ELLIPTA launch to date ~31% share in class Marketed in >38 countries, including China launched in 4Q19 sNDA filed 2Q19 for mortality benefit compared with ANORO in COPD sNDA f
Slide 8: YUPELRI (revefenacin) inhalation solution
YUPELRI ® (revefenacin) inhalation solution First and only once - daily, nebulized maintenance medicine for COPD
Slide 9: First and only once-daily, nebulized maintenance medicine for COPD
First and only once - daily, nebulized maintenance medicine for COPD YUPELRI ® (revefenacin) inhalation solution FDA - APPROVED FOR THE MAINTENANCE TREATMENT OF COPD 1. Global Strategy for Diagnosis, Management, and Prevention of COPD, 2018; 2. TBPH market research (N = 160 physicians); ref ers to U
Slide 10: YUPELRI commercial strategy
Patient remains on YUPELRI ® as maintenance therapy Patients converted and discharged from hospital with prescription for YUPELRI ® Patients with worsening COPD symptoms present in hospital 1. For COPD and other respiratory diseases. TBPH is eligible to receive up to $259 million in development and
Slide 11: YUPELRI launch metrics
Majority of YUPELRI® volume flows through durable medical equipment channel (approximately 3 month lag in data capture); rema ini ng volume flows through hospitals, retail and long - term care pharmacies. Wholesale acquisition cost (WAC): $1,066 per month (or ~$35 per day). 1. For patients with supp
Slide 12: Our science
Our science Organ - selective approach designed to optimize therapeutic index
Slide 13: Organ-selective approach optimizes therapeutic index
Organ - selective approach leverages proven and deep expertise in developing lung - selective medicines for respiratory disease 13 Conventional Systemic Compound Theravance Biopharma Organ - selective Compound Illustrated example: lung selectivity Expanded therapeutic index Narrow therapeutic index
Slide 14: TD-1473 (JNJ-8398) Oral gut-selective pan-JAK inhibitor
TD - 1473 (JNJ - 8398) Oral gut - selective pan - JAK inhibitor Goal: Treat inflammatory intestinal diseases
Slide 15: Improved preclinical profile of gut-selective pan-JAK inhibitor
Improved preclinical profile of a novel, potent, gut - selective pan - JAK inhibitor Tyk2: tyrosine kinase 2. 15 0 20 40 60 80 7.5 8 8.5 9 9.5 10 JAK1 Tyk2 % Absorbed 0 20 40 60 80 7.5 8 8.5 9 9.5 10 JAK1 Tyk2 % Absorbed Percent Inhibitory potency (pKi) Percent Inhibitory potency (pKi) Tofacitinib T
Slide 16: Systemic exposures low; tissue concentrations at or above JAK inhibition levels
Systemic exposures low; tissue concentrations at or above JAK inhibition levels Tofacitinib concentrations extracted from J Pharmacol Exp Ther 348:165 – 173, January 2014. BID: twice daily; Hr: hours; IC 50 : concentration to produce 50% maximal inhibition; PK: pharmacokinetics. 16 Plasma Concentrat
Slide 17: Potential for increased efficacy and safety with gut selectivity
Potential for increased efficacy and safety with gut selectivity 1. Presented at the European Crohn’s and Colitis Organization meeting, March 8, 2019, Copenhagen, Denmark. 2. Component of total Mayo score clinical response. 3. Maintenance phase of the study will have induction responder patients re
Slide 18: TD-1473: late-stage studies in ulcerative colitis and Crohn's disease
TD - 1473: Gut - selective pan - JAK inhibitor LATE - STAGE STUDIES IN ULCERATIVE COLITIS AND CROHN’S DISEASE Phase 2 Crohn’s and Phase 2b/3 UC studies ongoing Phase 2 Crohn’s and Phase 2b UC data expected late - 2020 Global collaboration with JNJ leverages joint development expertise and provides s
Slide 19: TD-8236 Inhaled lung-selective pan-JAK inhibitor
TD - 8236 Inhaled lung - selective pan - JAK inhibitor Goal: Treat moderate - to - severe asthma regardless of T2 phenotype
Slide 20: High medical and economic burden in uncontrolled asthma
High medical and economic burden in uncontrolled asthma 1. 2018 DR/Decision Resources, LLC. All rights reserved. Reproduction, distribution, transmission or publication is prohibited ; reprinted with permission; 2. Sadatsafavi , M., et al. Can Respir J 2010;17:74 - 80; 3. Nurmagambetov T, et al. Ann
Slide 21: TD-8236: preliminary positive FeNO data in mild asthmatics
-16 -14 -12 -10 -8 -6 -4 -2 0 2 1 2 3 4 5 6 7 TD - 8236: Lung - selective pan - JAK inhibitor PRELIMINARY POSITIVE FENO DATA IN MILD ASTHMATICS FeNO: fractional exhaled nitric oxide. 21 Phase 1 data; mild asthmatics ( 6 - Hour Post - Dose FeNO) Day BL 4000 µg 500 µg 1500 µg 150 µg Placebo - adjusted
Slide 22: TD-8236: Phase 2 allergen challenge study
TD - 8236: Lung - selective pan - JAK inhibitor PHASE 2 ALLERGEN CHALLENGE STUDY FeNO: fractional exhaled nitric oxide. 22 Phase 2 allergen challenge study underway Data expected 2020 TD - 8236 Phase 2 Lung Allergen Challenge 12 weeks (N=21) Dose characterization Randomized, double - blind, placebo
Slide 23: Early-stage organ-selective programs
Early - stage organ - selective programs
Slide 24: Opportunity to address multiple therapeutic areas with organ-selective approach
Opportunity to address multiple therapeutic areas with novel organ - selective approach 1. TD - 5202 is being developed in collaboration with Janssen Biotech, Inc. for inflammatory intestinal diseases e.g. celiac disea se. 2. Theravance Biopharma and Pfizer Inc. entered into a global license agreeme
Slide 25: Ampreloxetine (TD-9855) for symptomatic nOH
Ampreloxetine (TD - 9855) Once - daily norepinephrine reuptake inhibitor for symptomatic neurogenic orthostatic hypotension
Slide 26: Reduced quality of life and limited options for symptomatic nOH patients
Reduced quality of life, significant care - giver burden and limited therapeutic options for symptomatic nOH patients 1. Ha AD, et al. Parkinsonism Relat Disord 2011;17:625 - 8; 2. Mathias C, et al. J Neurol 1999;246:893 - 8. nOH : neurogenic orthostatic hypotension; MSA: multiple system atrophy; PA
Slide 27: Ampreloxetine mechanism: prolonging effect of endogenous norepinephrine
Untreated nOH NE Release at Neurovascular Junction Systolic Blood Pressure Designed to reduce symptoms of nOH by prolonging the effect of endogenous norepinephrine 1. Palma JA, Kaufmann H. Mov Disord Clin Pract 2017;4:298 - 308. NE: norepinephrine; NET: norepinephrine transporters. 27 Vasodilation B
Slide 28: Potential for durable symptom improvement in underserved patients
Potential to provide meaningful and durable symptom improvement to underserved patients Baseline OHSA #1 (Orthostatic Hypotension Symptom Assessment Question 1) >4 points. Negative change indicates improvement in symptoms; improvement of 1 point is defined as the MCID (minimal clinically importan t
Slide 29: The Theravance Biopharma Difference
The Theravance Biopharma Difference
Slide 30: Multiple potential milestones and value driving catalysts in 2020 and beyond
TRELEGY ELLIPTA 1 ‣ FDA approval decision for asthma ‣ FDA approval decision for mortality benefit vs. ANORO in COPD TD - 8236 ‣ Phase 1 Part C data in severe asthmatics ‣ Phase 2 allergen challenge data TD - 5202 ‣ Phase 1 topline data Ampreloxetine ‣ Phase 3 4 - week efficacy data TD - 1473 ‣ Phas
Slide 31: Creating transformational value for stakeholders
Creating transformational value for stakeholders 31 Innovative research yielding organ - selective assets Proven development and commercial expertise Strategic partnerships Value driving catalysts Strong capital position
Slide 32: Strategic objective
Strategic objective 32 Transform the treatment of serious diseases through the discovery, development, and commercialization of organ - selective medicines designed to maximize patient benefit while minimizing patient risk
Slide 33: About YUPELRI (revefenacin) inhalation solution
About YUPELRI ® (revefenacin) inhalation solution YUPELRI ® (revefenacin) inhalation solution is a novel once - daily nebulized LAMA approved for the maintenance treatment of COPD in the US . Market research by Theravance Biopharma indicates approximately 9 % of the treated COPD patients in the US u
Slide 34: YUPELRI indication and Important Safety Information
YUPELRI ® (revefenacin) inhalation solution YUPELRI® inhalation solution is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD) . Important Safety Information (US) YUPELRI is contraindicated in patients with hypersensitivity to revefenacin or any com
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