Theravance Biopharma, Inc. · NASDAQ:TBPH
Theravance Biopharma — FY2022 Earnings Presentation
31 slides from Theravance Biopharma's earnings presentation, Feb 27, 2023
Slide 1: Strategic Actions and Fourth Quarter / Full Year 2022 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 Actions Focused on Continued Value Creation
Strategic Actions Focused on Continued Value Creation 4 PIFR, peak inspiratory flow rate. AGM, Annual General Meeting – May 2, 2023 Authorized $325M Capital Return Program Approved incremental $75M to existing $250M program initiated Sept‘22, with goal to complete program by end of 2023 • Repurchase
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 trigg
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) 6
Slide 7: YUPELRI | Growing Net Sales and Hospital Volume
93,450 97,770 107,790 113,220 137,760 K 20 K 40 K 60 K 80 K 100 K 120 K 140 K 160 K Q4'21 Q1'22 Q2'22 Q3'22 Q4'22 $15.3 $15.3 $17.2 $18.7 $19.5 0 4 8 12 16 20 24 Q4'21 Q1'22 Q2'22 Q3'22 Q4'22 YUPELRI ® | Growing Net Sales and Hospital Volume 7 Source: IQVIA DDD, HDS, VA and Non - Reporting Hospital
Slide 8: YUPELRI Hospital Sales and Community TRx Trends
YUPELRI ® Hospital Sales and Community TRx Trends Hospital share dropped slightly due to largest Q/Q growth in market volume since YUPELRI launch 8 1. Joint VTRS/TBPH Market Research. * Hospital LA - NEB Market Share - IQVIA DDD through 12/31/2022. †Community LA - NEB Market Share includes Retail +
Slide 9: YUPELRI: Phase 4 Randomized, Double-Blind, Parallel-Group 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) 9 Phase 4, Randomized, Double - Blind, Parallel˗Group Study in Adults With Severe - to - Very - Severe COPD and Suboptimal I
Slide 10: Ampreloxetine
Ampreloxetine Investigational once - daily norepinephrine reuptake inhibitor For symptomatic neurogenic orthostatic hypotension ( nOH ) in multiple system atrophy (MSA) patients 10
Slide 11: New Era in Treating MSA Symptoms: Product Positioning
New Era in Treating MSA Symptoms: Product Positioning 11 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 ca
Slide 12: 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 13: Study 0197 (CYPRESS): 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 13 MSA, multiple system atrophy; nOH , neurogenic orthostatic hypotension; OHSA, orthostatic hypotension symptom assessme
Slide 14: Financial Update
Financial Update 14
Slide 15: $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 ~$27M completed in 2023, through 2/27/23 $325 Million Capital Return Program 15 Complete Open Market Share Buybacks ~50% (or ~$155M) of $325M capital return pr
Slide 16: Q4 2022 Financial Highlights
Q4 2022 Financial Highlights Beginning 2023 from a position of strength 16 1. Cash, cash equivalents and marketable securities. SBC, Share - based compensation. Metric Amount (M) Note Cash and Cash Equivalents 1 (as of December 31, 2022) $327.5 • $118M taxes paid in Q4’22 for sale of TRELEGY royalty
Slide 17: 2023 Financial Guidance
2023 Financial Guidance Expected to generate non - GAAP 1 Profit in 2H 2023 17 1. Non - GAAP profit is expected to consist of GAAP income before taxes less share - based compensation expense and non - cash interest e xpense; see the section titled "Non - GAAP Financial Measure" for more information.
Slide 18: TRELEGY ELLIPTA Milestones and Royalties
Q4 Net Sales of $537M | 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 18 1. If both milestones are achieved in a given year, Theravance Bioph
Slide 19: 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 20: Management Team and Q&A Session
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 21: 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 22: 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 23: Appendix
Theravance WK Biopharma AK. Medicines That Make a Difference” Appendix
Slide 24: Appoints Susannah Gray to Board as new Independent Director
Appoints Susannah Gray to Board as new Independent Director 24 Susannah Gray served as the Executive Vice President and Chief Financial Officer of Royalty Pharma, the largest aggregator of pharmaceutical royalty interests worldwide, from January 2005 to December 2018. She was promoted to Executive V
Slide 25: Recent Accomplishments and Highlights
‣ 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
Slide 26: Patent Protection Into Late 2030s
Patent Protection Into Late 2030s 26 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 27: Substantial Opportunity for Further YUPELRI Growth
Substantial Opportunity for Further YUPELRI ® Growth Once - Daily Nebulized LAMA COPD treatment represents a sizeable niche market 27 1. American Lung Association. 2. Clarivate COPD Disease Landscape & Forecast US 2021. 3. Revefenacin COPD Joint Venture Research 2016. COPD, chronic obstructive pulmo
Slide 28: Offering Hope to MSA Patients with Symptomatic nOH
Offering Hope to MSA Patients with Symptomatic nOH 28 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 29: 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 30: Theravance Biopharma and Royalty Pharma Deal Summary
TRELEGY ELLIPTA Theravance Biopharma and Royalty Pharma Deal Summary • Upfront: $1.1B (Received) • Milestones: Up to $250M 30 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 31: Fourth Quarter 2022 Financials
Fourth Quarter 2022 Financials $ 327.5 million cash 1 as of December 31 , 2022 31 1. Cash, cash equivalents and marketable securities. 2. Amounts include share - based compensation. ($, in thousands) Revenue: Viatris collaboration agreement $ 14,613 $ 12,132 $ 48,624 $ 43,848 Viatris royalties (Non-