Theravance Biopharma, Inc. · NASDAQ:TBPH
Theravance Biopharma — Q1 2023 Earnings Presentation
41 slides from Theravance Biopharma's earnings presentation, May 8, 2023
Slide 1: First Quarter 2023 Financial Results and Business Update
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. F
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: Agenda
Introduction and Overview Rick E Winningham Chief Executive Officer Commercial and Development Update Rhonda F. Farnum Senior Vice President, Chief Business Officer Richard A. Graham Senior Vice President, Research and Development Financial Update Aziz Sawaf Senior Vice President, Chief Financial Of
Slide 4: 2023 Targets
2023 Targets 4 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 trigg
Slide 5: Progress Against 2023 YUPELRI Targets
‣ Total YUPELRI reported net sales reach $47.0M up 8% Y/Y 1 ‣ Retail new patient starts and total prescriptions up 61% and 29% Y/Y, accelerating from Q4 ‣ YUPELRI market shares again reac h new h ighs ‣ On track to complete PIFR - 2 study and provide top - line results in 2H’23 ‣ Continue YUPELRI Ne
Slide 6: Progress Against 2023 Ampreloxetine Targets
MSA, multiple system atrophy; nOH , neurogenic orthostatic hypotension . Progress Against 2023 Ampreloxetine Targets Milestones Achieved with CYPRESS Study ‣ Initiate Phase 3 CYPRESS trial in MSA patients with symptomatic nOH in Q1’23 ‣ Submit orphan drug designation request in early 2023 Target ‣ I
Slide 7: Progress Against 2023 Financial Targets
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 Royalty
Slide 8: 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)
Slide 9: YUPELRI Growing Net Sales and Hospital Volume
97,770 107,790 113,220 137,760 158,550 K 20 K 40 K 60 K 80 K 100 K 120 K 140 K 160 K 180 K Q1'22 Q2'22 Q3'22 Q4'22 Q1'23 $43.7 $49.1 $53.4 $55.7 $47.0 0 10 20 30 40 50 60 Q1'22 Q2'22 Q3'22 Q4'22 Q1'23 YUPELRI ® | Growing Net Sales and Hospital Volume 9 1. In the US, Viatris is leading the commercial
Slide 10: YUPELRI Hospital and Community Share Trends
YUPELRI ® Hospital and Community Share Trends 10 1. Joint VTRS/TBPH Market Research. * Hospital LA - NEB Market Share - IQVIA DDD through 3/31/2023. †Community LA - NEB Market Share includes Retail + DME / Med B FFS through Jan’23 ǂRetail TRx Volume - Symphony Health METYS Prescription Dashboard thr
Slide 11: Continued Record-High Retail New Patient Starts
Continued Record - High Retail New Patient Starts 61% Y/Y and 23% Q/Q growth; Key Driver of Future Brand Performance 11 1. Retail data serves as a proxy for the total community (Retail + DME) Source: Symphony Health METYS Prescription Dashboard through 3/31/2023 0 500 1,000 1,500 2,000 2,500 3,000 3
Slide 12: Development
Development YUPELRI PIFR - 2 Top - line results anticipated H2 ‘23 CYPRESS (ampreloxetine) Last patient enrolled anticipated H2 ‘24
Slide 13: PIFR-Experience Informed PIFR-Design
PIFR - 1 Experience Informed PIFR - 2 Design Chronic Obstr Pulm Dis . 2019; 6(4): 321 – 331. Note: The ns shown are the numbers in the analysis set or subset. Evaluable ns are 90 (Tio) and 89 (Rev) for the ITT analysis an d 70 (Tio) and 70 (Rev) for the subset analysis. FEV1, forced expiratory volum
Slide 14: YUPELRI Phase 4 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) 14 Phase 4, Randomized, Double - Blind, Parallel˗Group Study in Adults With Severe - to - Very - Severe COPD and Suboptimal
Slide 15: Ampreloxetine
Ampreloxetine Investigational once - daily norepinephrine reuptake inhibitor For symptomatic neurogenic orthostatic hypotension ( nOH ) in multiple system atrophy (MSA) patients
Slide 16: Our CYPRESS Study is Now Recruiting
16 MSA, multiple system atrophy; nOH , neurogenic orthostatic hypotension. Our CYPRESS Study is Now Recruiting
Slide 17: Ampreloxetine: Designed to Reduce Symptoms in MSA
Untreated nOH NE Release Systolic Blood Pressure Ampreloxetine: Designed to Reduce Symptoms in MSA 17 Palma JA, Kaufmann H. Mov Disord Clin Pract 2017;4:298 - 308. 1. Data from MSA patients reported after 4 weeks of ampreloxetine administration in study 0169. 2. Data from MSA patients at week 6 of t
Slide 18: Effective Treatment Requires Intact Peripheral Nerves
18 Effective Treatment Requires Intact Peripheral Nerves REFERENCES: Fanciulli A, Wenning GK. Multiple - system atrophy. N Engl J Med. 2015;372(3):249 - 263. Jordan J, Shibao C, Biaggioni I. Multiple system atrophy: using clinical pharmacology to reveal pathophysiology. Clin Auton Res . 2015;25(1):5
Slide 19: Increased Norepinephrine, Prevented Blood Pressure Drop and Symptoms Worsening in MSA
Increased Norepinephrine, Prevented Blood Pressure Drop and Symptoms Worsening in MSA 1, 2 19 1. Data from MSA patients. Error bars represent SE. * p < 0.05 comparison to baseline reported after 4 weeks of ampreloxetine administration in study 0169. 2. Data from MSA patients at week 6 of the randomi
Slide 20: The Unique Benefits of Ampreloxetine Treatment
Study 0170 OHQ Questionnaire Scores LS Mean (95% CI) OHSA Symptoms composite score - 1.6 ( - 2.7, - 0.5) Dizziness - 1.5 ( - 3.2, 0.2) Vision - 1.7 ( - 3.2, - 0.3) Weakness - 0.7 ( - 2.3, 0.9) Fatigue - 1.5 ( - 3.1, 0.1) Trouble concentrating - 1.8 ( - 3.3, - 0.4) Head/neck discomfort - 2.2 ( - 3.7,
Slide 21: Offering Hope to MSA Patients with Symptomatic nOH
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 21 Enrichment Strategies for Clinical Trials to Support Determination of Effectiveness of Human Drugs and Biological Prod
Slide 22: New Era in Treating MSA Symptoms: Product Positioning
New Era in Treating MSA Symptoms: Product Positioning 22 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 on file. 1. U CS D Neurological Institute (25K - 75K, with ~10K new
Slide 23: Financial Update
Financial Update
Slide 24: First Quarter 2023 Financials
First Quarter 2023 Financials 24 1. Amounts include share - based compensation. 2. Non - GAAP net loss from continuing operations consists of [GAAP net loss before taxes excluding share - based compensation expen se and non - cash interest expense]; see reconciliation on Slide 25 and the section tit
Slide 25: First Quarter 2023 Financials (Cont'd)
First Quarter 2023 Financials (Cont’d) 25 GAAP Net Loss from Continuing Operations $ (22,088) $ (40,259) Adjustments: Share-based compensation expense 7,021 14,545 Non-cash interest expense 550 - Income tax expense (benefit) (395) 524 Non-GAAP Net Loss from Continuing Operations $ (14,912) $ (25,190
Slide 26: Q1 2023 Financial Highlights
Q1 2023 Financial Highlights Significant Capital Returns from a Position of Strength 26 1. Non - GAAP loss from continuing operations consists of GAAP loss before taxes excluding share - based compensation expense and no n - cash interest expense; see reconciliation on Slide 25 and the section title
Slide 27: $325 Million Capital Return Program
x ~$95M: Purchased GSK's equity stake in Theravance (Sep’22) and completed Dutch auction tender offer (Nov’22) x ~$33M completed in Dec’22 x ~$55M completed in 2023, through 3/31/23 x ~$87M completed in 2023, through 4/30/23 $325 Million Capital Return Program On Track to Complete Program by Year -
Slide 28: 2023 Financial Guidance
2023 Financial Guidance Expected to Generate Non - GAAP 1 Profit in 2H 2023 28 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.
Slide 29: Theravance Biopharma: Positioned for Value Creation
Theravance Biopharma: Positioned for Value Creation MSA, multiple system atrophy; nOH , neurogenic orthostatic hypotension. Ampreloxetine for nOH new era in treating MSA symptoms Substantial opportunity for further growth Potential to offer a unique, first in class treatment benefit Retained future
Slide 30: Q&A Session
Rick E Winningham Chairman and Chief Executive Officer Aziz Sawaf, CFA Senior Vice President, Chief Financial Officer Rhonda F. Farnum Senior Vice President, Chief Business Officer Richard A. Graham Senior Vice President, Research and Development Q&A Session
Slide 31: YUPELRI 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 32: 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 33: Appendix
Theravance WK Biopharma AK. Medicines That Make a Difference” Appendix
Slide 34: Patent Protection Into Late 2030s
Patent Protection Into Late 2030s 34 COPD, Chronic obstructive pulmonary disease ; nOH , neurogenic orthostatic hypotension; PTE, patent term extensions. Compound Invention Granted / Pending Application Estimated Patent Expiry YUPELRI ® / revefenacin Composition of Matter Granted US 2028 (once PTE a
Slide 35: Viatris Collaboration Agreement Revenue
35 Viatris Collaboration Agreement Revenue Theravance Entitled to Share of US profits (65% to Viatris; 35% to Theravance) 1. Any reimbursement from Viatris attributed to the 65% cost - sharing of our R&D expenses is characterized as a reduction of R&D expense. 2. Amount included as a receivable on t
Slide 36: TRELEGY ELLIPTA Milestones and Royalties
Q1’23 Net Sales of $ 567M | FY 2022 Net Sales of $2.1B 4 Outer - Year Royalties 3 return in 2029: TRELEGY ELLIPTA Milestones and Royalties GSK’s TRELEGY ELLIPTA (FF/UMEC/VI): First and only once - daily single inhaler triple therapy 36 1. If both milestones are achieved in a given year, Theravance B
Slide 37: Theravance Biopharma and Royalty Pharma Deal Summary
TRELEGY ELLIPTA Theravance Biopharma and Royalty Pharma Deal Summary • Upfront: $1.1B (Received) • Milestones: Up to $250M 37 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 38: Substantial Opportunity for Further YUPELRI Growth
Substantial Opportunity for Further YUPELRI ® Growth Once - Daily Nebulized LAMA COPD treatment represents a sizeable niche market 38 1. American Lung Association. 2. Clarivate COPD Disease Landscape & Forecast US 2021. 3. Revefenacin COPD Joint Venture Research 2016. COPD, chronic obstructive pulmo
Slide 39: Offering Hope to MSA Patients with Symptomatic nOH
Offering Hope to MSA Patients with Symptomatic nOH 39 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 40: 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 41: Recent Highlights Summary
‣ Sold TRELEGY ELLIPTA royalty interests for $1.1B upfront , while retaining value through milestones and certain outer - year royalties ‣ Eliminated all debt, ~$650 million ‣ Completed financial restructuring ‣ Initiated $250 million capital return program , of which ~62% was completed as of Februa