Theravance Biopharma, Inc. · NASDAQ:TBPH
Theravance Biopharma — Investor Presentation (September 2022)
25 slides from Theravance Biopharma's investor presentation, Sep 13, 2022
Slide 1: Transformed and Focused on Medicines that Make a Difference
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 herein are the property of their respective owners. T
Slide 2: Forward-looking Statements
Forward - looking Statements This presentation contains certain "forward - looking" statements as that term is defined in the Private Securities Litigation Ref orm Act of 1995 regarding, among other things, statements relating to goals, plans, objectives, expectations and future events. Theravance B
Slide 3: Theravance Biopharma At-a-Glance
Theravance Biopharma At - a - Glance 3 MSA, multiple system atrophy; PIFR, peak inspiratory flow rate. • Commercial product poised for significant near - term growth • YUPELRI PIFR - 2 Phase 4 • Phase 3 potential therapy for MSA patients with opportunity to differentiate from existing treatment opti
Slide 4: Theravance Biopharma Transformation
Free Cash Flow High cash burn Decreased cash burn Expect to be cash flow positive by 2023 Capital Structure $230M Convertible Senior Notes $420M Non - recourse TRELEGY Notes Debt - free Finalizing capital return program YUPELRI ® Slow launch due to pandemic headwinds Significant growth opportunities
Slide 5: Investment Highlights
Investment Highlights • Transformed and focused therapeutics company • Attractive pipeline and programs with YUPELRI ® , ampreloxetine and retained potential significant TRELEGY value • Strong, debt - free balance sheet • Finalizing capital return program • Sustainable, annual cash flow generation 2
Slide 6: Theravance Biopharma: Key Pillars of Value
Theravance Biopharma: Key Pillars of Value 6 MSA, multiple system atrophy; nOH , neurogenic orthostatic hypotension. Ampreloxetine in MSA Substantial opportunity for further growth in sizeable niche addressable patient population Investigational compound with potential to markedly differentiate from
Slide 7: 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 7 35% 65%
Slide 8: YUPELRI Hospital Sales and Community TRx Trends
YUPELRI ® Hospital Sales and Community TRx Trends 8 1. Joint VTRS/TBPH Market Research. * Hospital LA - NEB Market Share - IQVIA DDD through 6/30/2022. †Community LA - NEB Market Share includes Retail + DME / Med B FFS through Apr’22 ǂ Retail TRx Volume - Symphony Health METYS Prescription Dashboard
Slide 9: YUPELRI: Gaining Momentum in Sales and Hospital Volume
$12.9 $14.6 $13.8 $15.3 $15.3 $17.2 0 4 8 12 16 20 Q1'21 Q2'21 Q3'21 Q4'21 Q1'22 Q2'22 56,130 70,050 78,090 93,360 97,500 107,670 K 20 K 40 K 60 K 80 K 100 K 120 K Q1'21 Q2'21 Q3'21 Q4'21 Q1'22 Q2'22 YUPELRI ® | Gaining Momentum in Sales and Hospital Volume 9 Source: IQVIA DDD , HDS, VA and Non - Re
Slide 10: Substantial Opportunity for Further YUPELRI Growth
1. American Lung Association. 2. Clarivate COPD Disease Landscape & Forecast US 2021. 3. Revefenacin COPD Joint Venture Research 2016 & Symphony Health Metys . 4. Safka KA, et al. Chronic Obstr Pulm Dis 2017. 5. Estimated from IQVIA XPO and SolutionsRx Med B FFS prescription volume. 6. Trinity US YU
Slide 11: YUPELRI: Phase 4 Study (PIFR-2)
Randomization 1:1 2H ’23 Results YUPELRI SPIRIVA ® via HH* Once - daily treatment: 12 weeks N=488 Run - in YUPELRI ® : Phase 4 Randomized, Double - blind, Parallel - group Study (PIFR - 2) 11 Phase 4, Randomized, Double - Blind, Parallel ˗ Group Study in Adults With Severe - to - Very - Severe COPD
Slide 12: Ampreloxetine (TD-9855)
Ampreloxetine (TD - 9855) Investigational once - daily norepinephrine reuptake inhibitor for symptomatic neurogenic orthostatic hypotension in multiple system atrophy patients 12
Slide 13: Offering Hope to MSA Patients with Symptomatic nOH
Offering Hope to MSA Patients with Symptomatic nOH 13 1. 2019 IQVIA Claims Analysis; NIH; 2. Mathias CJ, et al. J Neurol 1999 Oct;246(10):893 - 8; 3. Data from MSA patients after 4 wee ks of ampreloxetine administration in study 0169. 4. Data from MSA patients at week 6 of the randomized withdrawal
Slide 14: Potential for ampreloxetine to differentiate from approved therapies
Offering Hope to MSA Patients with Symptomatic nOH Potential for ampreloxetine to differentiate from approved therapies 14 1. Reflects Theravance Biopharma's expectations for ampreloxetine based on clinical trial data to date. Ampreloxetine is in development and not approved for any indication. Data
Slide 15: Offering Hope to MSA Patients with Symptomatic nOH
Offering Hope to MSA Patients with Symptomatic nOH 15 33rd International Symposium on the Autonomic Nervous System November 2 – 5, 2022: Sheraton Maui, Lahaina, Hawaii Kaufmann H, et al. Abstract 33 / Virtual Poster 117 Blood pressure and pharmacodynamic response of ampreloxetine, a norepinephrine r
Slide 16: Phase 3 randomized withdrawal study in patients with MSA
Phase 3 randomized withdrawal study in patients with MSA Primary endpoint: change in OHSA composite score Offering Hope to MSA Patients with Symptomatic nOH 16 MSA, multiple system atrophy; nOH , neurogenic orthostatic hypotension; OHSA, orthostatic hypotension symptom assessment; RWD, randomized wi
Slide 17: Sale of Economic Interest: TRELEGY ELLIPTA
Sale of Economic Interest GSK’s TRELEGY ELLIPTA (FF/UMEC/VI): Once - daily single inhaler triple therapy 17
Slide 18: Retained Value of Theravance Biopharma's 85% TRELEGY ELLIPTA Interest
Retained Value of Theravance Biopharma’s 85% TRELEGY ELLIPTA Interest 1 18 1. All of its units in Theravance Respiratory Company, LLC. 2. The first milestone payment, of $50.0 million, will be triggered if Royalty Pharma receives $240.0 million or more in royalty pa yments from GSK with respect to 2
Slide 19: Theravance Biopharma and Royalty Pharma Deal Summary
TRELEGY ELLIPTA Theravance Biopharma and Royalty Pharma Deal Summary • Upfront: $1.1B • Milestones: Up to $250M 1. If both milestones are achieved in a given year, Theravance Biopharma will only earn the higher milestone. 2. Based on 100% of TRELEGY ELLIPTA royalties. 3. U.S. royalties expected to e
Slide 20: Financial Guidance
Financial Guidance • Reiterating 2022 OPEX guidance: – R&D: range of $45 – 55M – SG&A: range of $35 – 45M • 2022 guidance includes ~$10M in non - recurring spend: – Majority in Q1 to support completion of late - stage programs – OPEX Q3 and onward will reflect recurring spend only • Guidance exclude
Slide 21: Rick E Winningham Chairman and Chief Executive Officer Former CEO, Theravance, Inc. (now INVA)
Rick E Winningham Chairman and Chief Executive Officer Former CEO, Theravance, Inc. (now INVA) Former President (Oncology/ Immunology/Oncology Therapeutics Network), Bristol Myers Squibb Andrew A. Hindman Senior Vice President, Chief Financial Officer Former Chief Business Officer, Acorda Therapeuti
Slide 22: The Board of Directors
The Board of Directors Experienced leaders from a diverse range of relevant backgrounds 22 Dean Mitchell Former President & CEO, Lux Biosciences • Extensive management experience in the pharmaceutical and biotherapeutics industries with expertise in later stage drug development and commercialization
Slide 23: Investment Highlights
Investment Highlights • Transformed and focused therapeutics company • Attractive pipeline and programs with YUPELRI ® , ampreloxetine and retained potential significant TRELEGY value • Strong, debt - free balance sheet • Finalizing capital return program • Sustainable, annual cash flow generation 2
Slide 24: 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 co
Slide 25: 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 n
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