Theravance Biopharma, Inc. · NASDAQ:TBPH
Theravance Biopharma — Q3 2020 Earnings Presentation
25 slides from Theravance Biopharma's earnings presentation, Nov 5, 2020
Slide 1: Third Quarter 2020 Financial Results and Business Update
Third Quarter 2020 Financial Results and Business Update November 5, 2020 THERAVANCE BIOPHARMA ® , THERAVANCE ® , the Cross/Star logo and MEDICINES THAT MAKE A DIFFERENCE ® are registered trademarks of the Theravance Biopharma group of companies (in the U.S. and certain other countries). All third p
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 resul
Slide 3: Q3 Financial results and business update agenda
Q3 Financial results and business update agenda 3 Introduction Gail B. Cohen Vice President, Corporate Communications & Investor Relations Overview Rick E Winningham Chief Executive Officer Commercial and Development Update Frank Pasqualone Senior Vice President, Chief Commercial Operations Officer
Slide 4: YUPELRI (revefenacin) inhalation solution
YUPELRI ® (revefenacin) inhalation solution First and only once - daily, nebulized maintenance medicine for COPD
Slide 5: YUPELRI FDA-approved for the maintenance treatment of 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); refers to US COPD patients. COPD, chronic obstructive pulmonary disease; LAMA, lo
Slide 6: YUPELRI launch metrics
YUPELRI ® launch metrics Strong customer acceptance and market uptake Majority of YUPELRI ® volume flows through durable medical equipment channel (approximately 3 - month lag in data capture); remaining volume flows thro ugh hospitals, retail and long - term care pharmacies. Wholesale acquisition c
Slide 7: Pipeline programs
Program Indication Research Phase 1 Phase 2 Phase 3 Filed Marketed Collaborator Ampreloxetine (TD - 9855) NRI S ymptomatic nOH Wholly - owned Organ - Selective TD - 1473 GI JAKi UC CD TD - 5202 Irreversible JAK3i Inflammatory intestinal diseases YUPELRI ® (revefenacin) LAMA COPD TD - 8236 Inhaled JA
Slide 8: TD-8236 Potential first inhaled JAKi for asthma
TD - 8236 Potential first inhaled JAKi for asthma
Slide 9: TD-8236: Phase 1 clinical trial design
TD - 8236: Phase 1 clinical trial design Parts A & B completed September 2019; Part C enrollment completed — data reporting 4Q 2020 PART C MoA Biomarkers (Moderate - to - severe asthmatics + ICS) FeNO, fractional exhaled nitric oxide; ICS, inhaled corticosteroids; MAD, multiple ascending dose; pSTAT
Slide 10: TD-8236: Positive Phase 1 trial in healthy subjects and asthma patients
TD - 8236: Positive Phase 1 trial in healthy subjects and patients with mild and moderate/severe asthma ‣ Biomarkers of JAK target engagement (pSTAT1 and pSTAT6) significantly reduced in lungs of T2 high and T2 low moderate/severe asthmatics on top of inhaled corticosteroids ‣ Ongoing analysis of ef
Slide 11: No impact of TD-8236 on the Late Asthmatic Response
-50 -40 -30 -20 -10 0 10 20 30 40 -0.4 -0.2 0.0 0.2 0.4 Favors Placebo Favors TD - 8236 Favors TD - 8236 Favors Placebo No impact of TD - 8236 on the Late Asthmatic Response (LAR) Significant reductions in inflammation marker ( FeNO ) and favorable safety and tolerability ‣ TD - 8236 was generally w
Slide 12: TD-8236 FeNO Reductions Consistent Across Phase 1 and 2
-50 -40 -30 -20 -10 0 10 20 30 40 TD - 8236 FeNO Reductions Consistent Across Phase 1 and 2 ‣ FeNO reductions observed in moderate - to - severe asthmatics taking inhaled corticosteroids LAC, lung allergen challenge. 12 Phase 1 (Part B) Mild Asthmatics Phase 2 (LAC) Mild Asthmatics Phase 1 (Part C)
Slide 13: TD-0903 Program
TD - 0903 Program Nebulized lung - selective pan - JAK inhibitor to treat: ‣ Acute hyperinflammation of the lung in COVID - 19 ‣ Chronic inflammation for the prevention of lung transplant rejection
Slide 14: Potential for TD-0903 effect
Potential for TD - 0903 effect Host inflammatory response to COVID - 19 drives ALI and ARDS ALI Acute Lung Injury; ARDS, Acute respiratory distress syndrome Adapted from Siddiqi HK, et al. J Heart Lung Transplant 2020 Mar 20. CRP, C - reactive protein; LDH, lactate dehydrogenase; NT - proBNP, ventri
Slide 15: TD-0903: Development plan designed to progress rapidly
Phase 1: Healthy volunteers 1 mg 3 mg 10 mg Phase 2: Hospitalized COVID - 19 patients 1 mg 3 mg 10 mg Single - ascending dose Multiple - ascending dose x 7 days Dose X + SOC Placebo + SOC x x Part 2: Parallel group x 7 days 1 mg 3 mg 10 mg Repeat - dose safety, tolerability & PK Single - dose safety
Slide 16: TD-0903 Phase 1 Supports Initiation of Phase 2 in COVID-19
TD - 0903 Phase 1 Supports Initiation of Phase 2 in COVID - 19 Nebulized lung - selective pan - JAK inhibitor to treat acute hyperinflammation of the lung in COVID - 19 ‣ TD - 0903 was well tolerated as single daily doses across a dose range from 1 mg to 10 mg for 7 days in healthy subjects ‣ Advers
Slide 17: Economic interest GSK's TRELEGY ELLIPTA
Economic interest GSK’s TRELEGY ELLIPTA (FF/UMEC/VI): First and only once - daily single inhaler triple therapy
Slide 18: Economic interest in GSK's TRELEGY
Economic interest in GSK’s TRELEGY Upward - tiering royalties of ~5.5 – 8.5% of worldwide net sales 1 Q3 net sales of £194MM (or $252MM) Market share with sales up 45% year - over - year US asthma indication approved September 9, 2020, and launched this quarter ‣ Results from the CAPTAIN study publi
Slide 19: Third quarter 2020 financial highlights
Third quarter 2020 financial highlights Well - capitalized with $358.3 million 1 as of September 30, 2020 1. Cash, cash equivalents and marketable securities. 2. Amounts include share - based compensation. 19
Slide 20: The Theravance Biopharma Difference
The Theravance Biopharma Difference
Slide 21: Multiple potential milestones and value-driving catalysts expected in 2021
Q1 Q2 Q3 Q4 Multiple potential milestones and value - driving catalysts expected in 2021 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 Agreem
Slide 22: Creating transformational value for stakeholders
Creating transformational value for stakeholders 22 Innovative research yielding organ - selective molecular designed assets Proven development and commercial expertise Strategic partnerships Value driving catalysts Strong capital position
Slide 23: Holding steadfast to our mission
Holding steadfast to our mission 23 …treatments for serious diseases to maximize patient benefit while minimizing patient risk Discovering… Developing… Commercializing…
Slide 24: About YUPELRI (revefenacin) inhalation solution
About YUPELRI ® (revefenacin) inhalation solution YUPELRI ® (revefenacin) inhalation solution is a 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 use neb
Slide 25: 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 co