Theravance Biopharma, Inc. · NASDAQ:TBPH
Theravance Biopharma — Q3 2022 Earnings Presentation
26 slides from Theravance Biopharma's earnings presentation, Nov 7, 2022
Slide 1: Third Quarter 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. 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: Important Information Regarding the Tender Offer
Important Information Regarding the Tender Offer This slide presentation is for informational purposes only and is neither an offer to buy nor the solicitation of an offer to sell any of the Company’s ordinary shares, par value $ 0 . 00001 per share (the “Shares”) . A Dutch auction tender offer (the
Slide 4: 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 Andrew A. Hindman Senior Vice President, Chief Finan
Slide 5: Theravance Biopharma: Transformed and Focused
Theravance Biopharma: Transformed and Focused 5 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 f
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 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 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 through Aug’22 ǂ Retail TRx Volume - Symphony Health METYS Prescription Dashboard
Slide 9: Substantial Opportunity for Further YUPELRI Growth
Substantial Opportunity for Further YUPELRI ® Growth 9 1. American Lung Association. 2. Clarivate COPD Disease Landscape & Forecast US 2021. 3. Revefenacin COPD Joint Venture Research 2016. YUPELRI may be appropriate for COPD patients, including but not limited to: ► Moderate - to - very - severe CO
Slide 10: 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) 10 Phase 4, Randomized, Double - Blind, Parallel ˗ Group Study in Adults With Severe - to - Very - Severe COPD and Suboptima
Slide 11: Ampreloxetine (TD-9855)
Ampreloxetine (TD - 9855) Investigational once - daily norepinephrine reuptake inhibitor for symptomatic neurogenic orthostatic hypotension in multiple system atrophy 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 deve lop ment and
Slide 13: Offering Hope to MSA Patients with Symptomatic nOH
Offering Hope to MSA Patients with Symptomatic nOH 13 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 and pharmacodynamic response of ampreloxetine, a norepinephrine reuptake
Slide 14: 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 14 MSA, multiple system atrophy; nOH , neurogenic orthostatic hypotension; OHSA, orthostatic hypotension symptom assessme
Slide 15: TRELEGY Royalty Transaction
TRELEGY Royalty Transaction GSK’s TRELEGY ELLIPTA (FF/UMEC/VI): Once - daily single inhaler triple therapy 15
Slide 16: Retained Value of Theravance Biopharma's 85% TRELEGY ELLIPTA Interest
Retained Value of Theravance Biopharma’s 85% TRELEGY ELLIPTA Interest 1 16 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 17: Initiated $250 Million Capital Return Program
~9.6M shares at $9.75/share closed Sep. 20, 2022 to purchase up to $95M Theravance Biopharma ordinary shares initiated on Sep. 28, 2022, offer extended to midnight (NYC) Nov. 17, 2022 to repurchase ~$60M Theravance Biopharma ordinary shares Expected to initiate subsequent to completion of the Offer,
Slide 18: Third Quarter 2022 Financial Highlights
Third Quarter 2022 Financial Highlights $ 487 million cash 1 as of September 30 , 2022 18 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
Slide 19: 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 • Guidance excludes : – Non - cash share - based compensation (SBC) – One
Slide 20: Theravance Biopharma Transformed and Focused
Theravance Biopharma Transformed and Focused 20 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 treat
Slide 21: 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 Andrew A. Hindman Senior Vice President, Chief Financial Officer Former Chief Business Officer, Acorda Therapeuti
Slide 22: 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 23: 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 24: Appendix
Theravance WK Biopharma AK. Medicines That Make a Difference” Appendix
Slide 25: Potential for ampreloxetine to differentiate from approved therapies
Offering Hope to MSA Patients with Symptomatic nOH Potential for ampreloxetine to differentiate from approved therapies 25 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 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 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 ex