Theravance Biopharma, Inc. · NASDAQ:TBPH
Theravance Biopharma — Investor Presentation (January 2023)
27 slides from Theravance Biopharma's investor presentation, Jan 9, 2023
Slide 1: Theravance Biopharma Investor Presentation January 2023
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 Reform Act of 1995 regarding, among other things, statements relating to goals, plans, objectives, expectations and future events. Theravance Biopha
Slide 3: Theravance Biopharma: Positioned for Value Creation
Theravance Biopharma: Positioned for Value Creation MSA, multiple system atrophy. Ampreloxetine in MSA Substantial opportunity for further growth Potential to markedly differentiate from other treatment options Retained future value of TRELEGY in milestones and certain outer year royalties Retained
Slide 4: Recent highlights and accomplishments
‣ Sold TRELEGY ELLIPTA royalty interests for $1.1B upfront , while retaining value through milestones and certain outer - year royalties for TRELEGY ‣ Eliminated all debt ‣ Completed financial restructuring ‣ Initiated $250 million capital return program, of which ~50% was completed as of 12/31/22:
Slide 5: 2023 Targets
2023 Targets 5 1. Non GAAP profit is expected to consist of GAAP income before taxes less share based compensation expense and non cash interes t expense. See the section titled "Non GAAP Financial Measure" for more information. 2. The first milestone payment, of $50.0 million, will be triggered if
Slide 6: YUPELRI overview
FDA - approved for maintenance treatment of COPD First and only once - daily, LAMA (long - acting muscarinic agent) nebulized maintenance medicine for COPD Co - promotion agreement with VIATRIS TM (35% / 65% Profit Share) 6
Slide 7: YUPELRI: Growing Net Sales and Hospital Volume
78,090 93,360 97,650 107,670 113,220 K 20 K 40 K 60 K 80 K 100 K 120 K Q3'21 Q4'21 Q1'22 Q2'22 Q3'22 $13.8 $15.3 $15.3 $17.2 $18.7 0 4 8 12 16 20 Q3'21 Q4'21 Q1'22 Q2'22 Q3'22 YUPELRI ® | Growing Net Sales and Hospital Volume 7 Source: IQVIA DDD, HDS, VA and Non - Reporting Hospital through 9/30/202
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 8 1. Joint VTRS/TBPH Market Research. * Hospital LA - NEB Market Share - IQVIA DDD through 9/30/2022. †Community LA - NEB Market Share includes Retail + DME / Med B FFS throug
Slide 9: Substantial Opportunity for Further YUPELRI Growth
Substantial Opportunity for Further YUPELRI ® Growth Once - Daily Nebulized LAMA COPD treatment represents a sizeable niche market 9 1. American Lung Association. 2. Clarivate COPD Disease Landscape & Forecast US 2021. 3. Revefenacin COPD Joint Venture Research 2016. COPD, chronic obstructive pulmon
Slide 10: YUPELRI: Phase 4 Randomized Study (PIFR-2)
Randomization 1:1 Results YUPELRI SPIRIVA ® via HH* Once - daily treatment: 12 weeks Run - in YUPELRI ® : Phase 4 Randomized, Double - blind, Parallel - group Study (PIFR - 2) 10 Phase 4, Randomized, Double - Blind, Parallel˗Group Study in Adults With Severe - to - Very - Severe COPD and Suboptimal
Slide 11: Ampreloxetine
Ampreloxetine Investigational once - daily norepinephrine reuptake inhibitor For symptomatic neurogenic orthostatic hypotension ( nOH ) in multiple system atrophy (MSA) patients 11
Slide 12: Potential Differentiating Features from Other Therapies
First - in - class therapy effective in treating a constellation of cardinal symptoms in MSA patients: Potential Differentiating Features from Other Therapies 12 Reflects Theravance Biopharma's expectations for ampreloxetine based on clinical trial data to date. Ampreloxetine is in development and n
Slide 13: Study 0197 (CYPRESS): Phase 3 randomized withdrawal study in MSA
Study 0197 (CYPRESS): Phase 3 randomized withdrawal study in patients with MSA Primary endpoint: change in OHSA composite score Offering Hope to MSA Patients with Symptomatic nOH 13 MSA, multiple system atrophy; nOH , neurogenic orthostatic hypotension; OHSA, orthostatic hypotension symptom assessme
Slide 14: Financials
Financials Theravance “i Biopharma AK Medicines That Make a Difference
Slide 15: Retained Value of 85% TRELEGY ELLIPTA Interest
Retained Value of Theravance Biopharma’s 85% TRELEGY ELLIPTA Interest 1 15 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 16: $250 Million Capital Return Program
~$95M: Purchased GSK's equity stake in Theravance Biopharma (Sep'22) and completed Dutch auction tender offer (Nov'oInitiated open market share repurchase program in Q4'22oo~$33M completed as of 12/31/22$250 Million Capital Return Program16CompleteInitiated in Q4'22~50% (or ~$128M) of $250M capital
Slide 17: Financial Guidance
Financial Guidanceo2022 OPEX Range:-Total OPEX: narrowing range to $90 100M 1,2o2022 guidance includes ~$10M in non recurring spend:-Majority in Q1 to support completion of late stage programsoGuidance excludes-Non cash share based compensation (SBC)-One time restructuring, severance termination cos
Slide 18: Theravance Biopharma: Positioned for Value Creation
Theravance Biopharma: Positioned for Value Creation MSA, multiple system atrophy. Ampreloxetine in MSA Substantial opportunity for further growth Potential to markedly differentiate from other treatment options Retained future value of TRELEGY in milestones and certain outer year royalties Retained
Slide 19: Management team and Q&A
Rick E Winningham Chairman and Chief Executive Officer Former CEO, Theravance , Inc. (now INVA) Former President (Oncology/ Immunology/Oncology Therapeutics Network), Bristol Myers Squibb Aziz Sawaf , CFA Senior Vice President, Chief Financial Officer Former Theravance Biopharma, Vice President, Fin
Slide 20: 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
Slide 21: 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
Slide 22: Appendix
Theravance WK Biopharma AK. Medicines That Make a Difference” Appendix
Slide 23: Potential for ampreloxetine to differentiate from approved therapies
Droxidopa Midodrine Ampreloxetine 1 Indication Symptomatic nOH OH Symptomatic nOH associated with MSA MOA Norepinephrine prodrug; vasoconstrictor Desglymidodrine prodrug; alpha 1 - receptor agonist; vasoconstrictor Norepinephrine transporter reuptake inhibitor Dosing 3x daily, titration to effect 3x
Slide 24: Offering Hope to MSA Patients with Symptomatic nOH
Offering Hope to MSA Patients with Symptomatic nOH 24 MSA, multiple system atrophy; nOH , neurogenic orthostatic hypotension. 33rd International Symposium on the Autonomic Nervous System November 2 – 5, 2022: Sheraton Maui , Hawaii Kaufmann H, et al. Abstract 33 / Virtual Poster 117 Blood pressure a
Slide 25: Shift Toward Broad Symptomatic Improvement for MSA Patients
Shift Toward Broad Symptomatic Improvement for MSA Patients 1. Data from MSA patients at week 6 of the randomized withdrawal period of study 0170. 2. Biaggioni I, et al. Abstract 34 / Virtual Poster 106; Kaufmann H, et al. Abstract 33 / Virtual Poster 117; Freeman R, et al. Abstract 30 / Virtual Pos
Slide 26: TRELEGY ELLIPTA Theravance Biopharma and Royalty Pharma Deal Summary
TRELEGY ELLIPTA Theravance Biopharma and Royalty Pharma Deal Summary • Upfront: $1.1B (Received) • Milestones: Up to $250M 26 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
Slide 27: Third Quarter 2022 Financial Highlights
Third Quarter 2022 Financial Highlights $ 487 million cash 1 as of September 30 , 2022 27 1. Cash, cash equivalents and marketable securities. 2. Amounts include share - based compensation. ($, in thousands) Revenue: Viatris collaboration agreement $ 12,445 $ 10,397 $ 34,010 $ 31,716 Collaboration r
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