Theravance Biopharma, Inc. · NASDAQ:TBPH
Theravance Biopharma — FY2019 Earnings Presentation
30 slides from Theravance Biopharma's earnings presentation, Feb 24, 2020
Slide 1: Fourth Quarter and Full Year 2019 Financial Highlights and Business Update
Fourth Quarter and Full Year 2019 Financial Highlights and Business Update February 24, 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 t
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: TD-1473 Oral gut-selective pan-JAK inhibitor
TD - 1473 (JNJ - 8398) Oral gut - selective pan - JAK inhibitor Goal: Treat inflammatory intestinal diseases
Slide 7: TD-1473: Gut-selective pan-JAK inhibitor late-stage studies in UC and Crohn's
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 8: TD-5202 Organ-gut selective irreversible JAK3 inhibitor
TD - 5202 Organ - gut selective irreversible JAK3 inhibitor Goal: Treat inflammatory intestinal diseases
Slide 9: TD-5202 FIH Overall Results Summary
TD - 5202 FIH Overall Results Summary ‣ No SAEs or severe AEs were reported ‣ All treatment - emergent AEs in TD - 5202 - treated subjects were mild in severity AE: adverse event; C max,ss : maximal steady - state concentration; ECG: electrocardiogram; JAK: Janus kinase; IC 50 : half - maximal inhib
Slide 10: Ampreloxetine (TD-9855) for symptomatic neurogenic orthostatic hypotension
Ampreloxetine (TD - 9855) Once - daily norepinephrine reuptake inhibitor for symptomatic neurogenic orthostatic hypotension
Slide 11: Potential to provide meaningful and durable symptom improvement
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 12: 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 13: 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 14: TD-8236: Preliminary positive FeNO data in mild asthmatics
-16 -14 -12 -10 -8 -6 -4 -2 0 2 BL 1 2 3 4 5 6 7 TD - 8236: Lung - selective pan - JAK inhibitor PRELIMINARY POSITIVE FENO DATA IN MILD ASTHMATICS ‣ Phase 1 biomarker study in moderate to severe asthmatics ongoing; data expected mid - 2020 FeNO: fractional exhaled nitric oxide. 14 Phase 1 data; mild
Slide 15: TD-8236: Phase 2 allergen challenge study
TD - 8236: Lung - selective pan - JAK inhibitor PHASE 2 ALLERGEN CHALLENGE STUDY FeNO: fractional exhaled nitric oxide. 15 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 16: Early-stage organ-selective programs
Early - stage organ - selective programs
Slide 17: Opportunity to address multiple therapeutic areas with novel organ-selective approach
Opportunity to address multiple therapeutic areas with novel organ - selective approach 1. 1 May be overstated by up to 50% as based on a claims analysis rather than medical record review 17 Intravitreal eye - selective pan - JAKi Diabetic macular edema US prevalence: ~2.7 million Inhaled nebulized
Slide 18: YUPELRI (revefenacin) inhalation solution
YUPELRI ® (revefenacin) inhalation solution First and only once - daily, nebulized maintenance medicine for COPD
Slide 19: 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 20: 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 21: 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. As of December 27, 201
Slide 22: Fourth Quarter 2019 Financial Highlights
1 Cash, cash equivalents and marketable securities. 2 Amounts include share - based compensation. 3 Derived from the audited consolidated financial statements included in the Company’s 2018 Form 10 - K. 22 Fourth Quarter 2019 Financial Highlights WELL CAPITALIZED WITH $285.8M 1 AS OF DECEMBER 31, 20
Slide 23: 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 24: Economic interest in GSK's TRELEGY ELLIPTA upward-tiering royalties
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 fi
Slide 25: The Theravance Biopharma Difference
The Theravance Biopharma Difference
Slide 26: Multiple potential milestones and value driving catalysts in 2020 and beyond
TRELEGY ELLIPTA 1 ‣ FDA decision for asthma and separately for mortality benefit vs. ANORO in COPD ‣ Upsizing of note facility 2 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 -
Slide 27: Creating transformational value for stakeholders
Creating transformational value for stakeholders 27 Innovative research yielding organ - selective assets Proven development and commercial expertise Strategic partnerships Value driving catalysts Strong capital position
Slide 28: Strategic objective
Strategic objective 28 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 29: 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 30: 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