Theravance Biopharma, Inc. · NASDAQ:TBPH
Theravance Biopharma — Q2 2023 Earnings Presentation
35 slides from Theravance Biopharma's earnings presentation, Aug 7, 2023
Slide 1: Second 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. S
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: Strategic Objectives Focused on Value Creation
Strategic Objectives Focused on Value Creation 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 Measures” on Slide 2 for more information. MSA, multiple sys
Slide 5: 2023 Progress
2023 Progress 5 1. In the US, Viatris is leading the commercialization of YUPELRI, and Theravance Biopharma co - promotes the product under a prof it and loss sharing arrangement (65% to Viatris; 35% to Theravance Biopharma). 2 . Non - GAAP profit is expected to consist of GAAP income before taxes l
Slide 6: 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 Co - promotion agreement with VIATRIS TM (35% / 65% Profit Share)
Slide 7: YUPELRI: Growing Net Sales and Hospital Volume
107,790 113,220 137,760 159,720 156,180 K 20 K 40 K 60 K 80 K 100 K 120 K 140 K 160 K 180 K Q2'22 Q3'22 Q4'22 Q1'23 Q2'23 $49.1 $53.4 $55.7 $47.0 $55.0 0 10 20 30 40 50 60 Q2'22 Q3'22 Q4'22 Q1'23 Q2'23 YUPELRI ® | Growing Net Sales and Hospital Volume 7 1. In the US, Viatris is leading the commercia
Slide 8: YUPELRI Hospital and Community Share Trends
YUPELRI ® Hospital and Community Share Trends 8 1. Joint VTRS/TBPH Market Research. * Hospital LA - NEB Market Share - IQVIA DDD through 6/30/2023. †Community LA - NEB Market Share includes Retail + DME / Med B FFS through May’23. 6.6% 7.6% 7.6% 8.6% 9.5% 10.7% 11.3% 11.6% 13.3% 12.5% 14.9% 15.2% 0%
Slide 9: YUPELRI Retail Trends
9 Source: Symphony Health METYS Prescription Dashboard through 6/30/2023. 9.7% 6.8% - 2.0% 10.2% 4.9% 4.1% 6.9% 7.8% K 5 K 10 K 15 K 20 K 25 K 30 K 2021-Q2 2021-Q3 2021-Q4 2022-Q1 2022-Q2 2022-Q3 2022-Q4 2023-Q1 2023-Q2 YUPELRI Retail TRx YUPELRI Retail TRx YUPELRI Retail TRx - 6.1% 9.5% 0.1% 11
Slide 10: Substantial Opportunity for Further YUPELRI Growth
10 Substantial Opportunity for Further YUPELRI ® Growth Long - Acting Nebulized Maintenance Patients Patients Using Short - Acting Nebulized Therapy ~200K Current Long - Acting Neb Patients ~200K Patients Inappropriately Using Short - Acting Nebulized Treatments for Maintenance Therapy Current COPD
Slide 11: Development
Development YUPELRI PIFR - 2 Top - line results anticipated Q4 ‘23 CYPRESS (ampreloxetine) Last patient enrolled anticipated H2 ‘24
Slide 12: 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) 12 Phase 4, Randomized, Double - Blind, Parallel˗Group Study in Adults With Severe - to - Very - Severe COPD and Suboptimal
Slide 13: PIFR Experience Informed PIFR-2 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: Ampreloxetine
Ampreloxetine Investigational once - daily norepinephrine reuptake inhibitor For symptomatic neurogenic orthostatic hypotension (nOH) in multiple system atrophy (MSA) patients
Slide 15: High Probability of Technical Success
High Probability of Technical Success CYPRESS: Phase 3 randomized withdrawal (RWD) study in patients with MSA 15 Enrichment Strategies for Clinical Trials to Support Determination of Effectiveness of Human Drugs and Biological Products Gu ida nce for Industry https://www.fda.gov/media/121320/downloa
Slide 16: Symptoms of nOH in MSA: Significant Unmet Need
Symptoms of nOH in MSA: Significant Unmet Need 16 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. UCSD Neurological Institute (25K - 75K, with ~10K new cases per
Slide 17: Ampreloxetine's Potential for MSA Patients
Ampreloxetine’s Potential for MSA Patients: Highly Differentiated Therapy Delivering Significant Market Expansion 1. NORTHERA ® (droxidopa) [package insert]. Deerfield, IL: Lundbeck. 2014. 2. ProAmatine ® (midodrine hydrochloride) [Warning Ref 4052798]. Lexington, MA: Shire. 2017. 3. Low, AJMC, 2015
Slide 18: Financial Update
Financial Update Theravance “it Biopharma AK ‘Medicines That Make a Difference
Slide 19: Second Quarter 2023 Financials
Second Quarter 2023 Financials 19 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 expens e and non - cash interest expense; see reconciliation on Slide 20 and the section titl
Slide 20: Second Quarter 2023 Financials (Cont'd)
Second Quarter 2023 Financials (Cont’d) 20 See the section titled "Non - GAAP Financial Measures" on Slide 2 for more information. GAAP Net Loss from Continuing Operations $ (15,645) $ (22,793) $ (37,733) $ (63,052) Adjustments: Share-based compensation expense 6,264 9,709 13,285 24,254 Non-cash int
Slide 21: Q2 2023 Financial Highlights
Q2 2023 Financial Highlights Significant Capital Returns from a Position of Strength 21 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 20 and the section title
Slide 22: 2023 Financial Guidance
2023 Financial Guidance Expected to Generate Non - GAAP 1 Profit in 2H 2023 22 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 Measures" on Slide 2 for more
Slide 23: $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 >$80M completed in Q2 2023 $325 Million Capital Return Program On Track to Complete Program by Year - End 23 Complete ($95M) Open Market Share Buybacks Complete ($169M) ~$264M completed o
Slide 24: TRELEGY ELLIPTA Milestones and Royalties
Q2’23 Net Sales of $760 M |YTD Net Sales of $1.33B 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 24 1. If both milestones are achieved in a given year, Theravance Bioph
Slide 25: 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 26: 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 27: 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
Slide 28: 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 29: Appendix
Theravance WX Biopharma AK. Medicines That Make a Difference” Appendix
Slide 30: Patent Protection Into Late 2030s
Patent Protection Into Late 2030s 30 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 aw
Slide 31: Viatris Collaboration Agreement Revenue
31 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 32: TRELEGY ELLIPTA Royalty Pharma Deal Summary
TRELEGY ELLIPTA Theravance Biopharma and Royalty Pharma Deal Summary • Upfront: $1.1B (Received) • Milestones: Up to $250M 32 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 33: Offering Hope to MSA Patients with Symptomatic nOH
Offering Hope to MSA Patients with Symptomatic nOH 33 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 an
Slide 34: 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 35: Key accomplishments since prior update
‣ 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