Theravance Biopharma, Inc. · NASDAQ:TBPH
Theravance Biopharma — JP Morgan Healthcare Conference 2022
24 slides from Theravance Biopharma's conference presentation, Jan 10, 2022
Slide 1: JP Morgan Healthcare Conference January 13, 2022
JP Morgan Healthcare Conference January 13, 2022 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 party trademarks used here
Slide 2: Forward-looking statements safe harbor
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 to differ materially from th
Slide 3: Rapid transition to a streamlined, respiratory focused Theravance Biopharma
Rapid transition to a streamlined, respiratory focused Theravance Biopharma 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 nex
Slide 4: Key pillars of respiratory-focused value creation plan
Key pillars of respiratory - focused value creation plan 1. Source: TBPH Analysts Consensus [8] December 9, 2021. 2. Source: Bloomberg GSK Analysts Consensus December 16, 2021. JAK, Jan us kinase; PIFR, peak inspiratory flow rate. 3. TBPH holds 85% economic interest in upward - tiering royalty strea
Slide 5: YUPELRI: FDA-approved for maintenance treatment of COPD
FDA - approved for maintenance treatment of COPD First and only once - daily, LAMA (long - acting muscarinic agent) nebulized maintenance medicine for COPD
Slide 6: Once-daily LAMAs and nebulizer use in COPD
‣ Once - daily LAMAs are first - line therapy for moderate - to - very severe COPD 1 ‣ 9% of COPD patients (~800,000) use nebulizers for ongoing maintenance therapy; 41% use nebulizers at least occasionally for bronchodilator therapy 2 <83(/5, Š UHYHIHQDFLQ LQKDODWLRQ VROXWLRQ 1. Global Strategy for
Slide 7: Where the market has been
Where the market has been 6RXUFH 6+$ 0(7<6 WKURXJK 4 ¶ /$ 1(% ORQJ DFWLQJ QHEXOL]HU 7 ‣ Universal brand challenges – Reduced office visits – Reduced/limited new treatment starts ‣ Pulmonologists enlisted for ER, ICU, hospital, COVID outpatient evaluation ‣ Overall new product starts for pulmonologis
Slide 8: YUPELRI hospital sales and community TRx trends
YUPELRI ® hospital sales and community TRx trends Continued market share growth across both the hospital and retail channels 0.3 1.1 2.2 3.4 5.4 6.5 6.3 7.4 7.8 8.7 9.5 0% 5% 10% 15% 20% 25% Hospital LA - NEB Market Share 1 Hospital Market Share YUPELRI LA-NEB Market Share 1. Hospital LA - NEB Marke
Slide 9: YUPELRI hospital volume has returned to growth
0 2,000 4,000 6,000 8,000 10,000 YULPELRI Weekly Hospital Doses YUPELRI ® hospital volume has returned to growth Source: IQVIA DDD through 12/24/2021. 9 2019 Growth from launch 2020 Flat 2021 Return to growth Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov
Slide 10: Substantial opportunity for further YUPELRI growth
Substantial opportunity for further YUPELRI ® growth ‣ COPD is under - diagnosed 1 ‣ COPD patients with or without symptoms may be treated with rescue and/or maintenance therapies ‣ Estimated patient counts from volume using average ‘days of therapy’ assumptions vary considerably across DME and reta
Slide 11: Favorable YUPELRI outlook in 2022 and beyond
Favorable YUPELRI ® outlook in 2022 and beyond 11 1. Data on file from TBPH survey of HCPs October 2020 - October 2021. COPD, chronic obstructive pulmonary disease; PIFR, peak inspiratory flow rate; PPE, personal protective equipment ; QD, once a d ay. Additional potential growth opportunities Obser
Slide 12: Pipeline focused on highest value core respiratory opportunities
Pipeline focused on highest value core respiratory opportunities 1. Excluding programs that are in the process of being wound down following restructuring. JAK, Janus kinase; PIFR, peak inspiratory flow rate. 12 New Theravance: Core Respiratory Focused pipeline of core respiratory programs 1 Impleme
Slide 13: A new, respiratory focused Theravance Biopharma
A new, respiratory focused Theravance Biopharma 1. TBPH estimate derived from integrating multiple data sources 2. TBPH holds 85% economic interest in upward - tiering royalty st ream 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 pu
Slide 14: YUPELRI Phase 4 randomized study (PIFR-2)
YUPELRI ® : Phase 4 randomized, double - blind, parallel - group study (PIFR - 2) A Phase 4, Randomized, Double - Blind, Parallel˗Group Study in Adults With Severe to Very Severe COPD and Suboptimal Inspiratory Flow Rate. *Dry powder inhaler (Spiriva ® HandiHaler ®) . FEV 1 , forced expiratory volum
Slide 15: Lung-selective JAK inhibitor nezulcitinib in viral ARDS environment
Lung - selective JAK inhibitor nezulcitinib demonstrates potential to protect lungs in an IFN γ - driven viral ARDS hyperinflammatory environment *Comparable blockade in lung IL - 13 – pSTAT6 in vivo model; ****p<0.0001. ARDS, acute respiratory distress syndrome; IFN γ , interferon - gamma; IL - 6,
Slide 16: Phase 2 study: hospitalized patients with severe COVID-19
Study 0188 (NCT: 04402866). Ventilator - free survival is defined as elapsed time (in days) from randomization to first day a participant progresses to IMV or death. CI, confidence interval; CRP, C - Reactive protein; HR, hazard ratio; IMV, invasive mechanical ventilation; ITT, intent - to - treat.
Slide 17: Outcomes of the UK COVID Therapeutics Advisory Panel
Outcomes of the UK COVID Therapeutics Advisory Panel https://www.gov.uk/government/groups/the - covid - 19 - therapeutics - taskforce https://www.ukri.org/about - us/policies - standards - and - data/data - collection/uk - covid - 19 - therapeutics - advisory - panel/recommended - tr eatments - for
Slide 18: 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 19: Economic interest in GSK's TRELEGY
Economic interest in GSK’s TRELEGY 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). 75% of TRC in
Slide 20: Financial Guidance
Financial Guidance 1. Excluding share - based compensation (SBC) and one - time restructuring, severance and termination costs (estimated $18 – 20M betwe en 2021 and 2022, of which the majority will be incurred by Q1 2022). 20 Execution of cost - cutting initiatives results in lowered 2021 OPEX guid
Slide 21: Rapid transition to a streamlined, respiratory focused Theravance Biopharma
Rapid transition to a streamlined, respiratory focused Theravance Biopharma 21 Significant cost reduction program reduces Company size to become sustainably cash - flow positive beginning 2H 2022 Focus on leveraging expertise in developing and commercializing respiratory therapeutics Streamlined R&D
Slide 22: Q&A Session
Q&A Session Rick E Winningham Chairman and Chief Executive Officer Andrew A. Hindman Senior Vice President, Chief Financial Officer Rhonda F. Farnum Senior Vice President, Commercial and Medical Affairs Richard A. Graham Senior Vice President, Research and Development
Slide 23: YUPELRI (revefenacin) inhalation solution: 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
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
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