Theravance Biopharma, Inc. · NASDAQ:TBPH
Theravance Biopharma — Q1 2024 Earnings Presentation
44 slides from Theravance Biopharma's earnings presentation, May 13, 2024
Slide 1: First Quarter 2024 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 Bio
Slide 3: Agenda
Introduction Rick Winningham Chief Executive Officer Ampreloxetine Update Áine Miller Senior Vice President, Head of Development YUPELRI ® Update Rhonda Farnum Senior Vice President, Chief Business Officer Financial Update Aziz Sawaf Senior Vice President, Chief Financial Officer Closing Remarks Ric
Slide 4: Strategic Objectives: Q1 2024 Progress
Strategic Objectives: Q1 2024 Progress 4 1. Source: GSK - reported Net Sales in USD. 2. Theravance stands to receive up to $200 million in Trelegy sales milestones paid directly from Royalty Pharma. The first p aym ent, of $25 million, will be triggered if Royalty Pharma (RP) receives $240 million o
Slide 5: 1. In the US, Viatris is leading the commercialization of YUPELRI, and Theravance Biopharma
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 . As of March 31, 2024 . 3 . As of March 31, 2024, Theravance Biopharma is eligible to
Slide 6: Ampreloxetine
Ampreloxetine Investigational once - daily norepinephrine reuptake inhibitor For symptomatic neurogenic orthostatic hypotension (nOH) in multiple system atrophy (MSA) patients
Slide 7: Phase 3 CYPRESS Study Update
Phase 3 CYPRESS Study Update Maximizing the Probability of Clinical and Regulatory Success 7 1. Kaufmann H. (2023, November 15 - 18). Evaluating clinically meaningful changes in the Orthostatic Hypotension Symptom Assessmen t domain of the Orthostatic Hypotension Questionnaire. [Poster presentation]
Slide 8: Virtual KOL Event on Ampreloxetine
VIRTUAL KOL EVENT To Discuss Ampreloxetine’s Promise for the Treatment of Symptomatic Neurogenic Orthostatic Hypotension (nOH) in Patients with Multiple System Atrophy (MSA) Horacio Kaufmann, MD, FAAN (New York University) Thursday, May 23, 2024 | 10:00 AM ET Italo Biaggioni, MD (Vanderbilt Universi
Slide 9: 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 10: YUPELRI Continued Y/Y Net Sales Growth
YUPELRI ® Continued Y/Y Net Sales Growth 10 In the US, Viatris is leading the commercialization of YUPELRI, and Theravance Biopharma co - promotes the product under a profit and loss sharing arrangement (65% to Viatris; 35% to Theravance Biopharma). $16.5 $29.6 $36.8 $30.3 $37.0 $38.7 $36.9 $41.8 $3
Slide 11: Theravance Hospital Execution Drives Value
Theravance Hospital Execution Drives Value 11 1. Source: IQVIA DDD, HDS, VA and Non - Reporting Hospital through Mar’24. Preliminary data subject to revision upon receipt of fi nal data. 19K 30K 54K 34K 47K 54K 56K 70K 78K 93K 98K 108K 113K 138K 162K 158K 162K 191K 213K 0K 50K 100K 150K 200K 250K Q3
Slide 12: YUPELRI Market Share Progression
YUPELRI ® Market Share Progression 12 1. Joint VTRS/TBPH Market Research (Aug’23). * Hospital LA - NEB Market Share - IQVIA DDD through Mar’24. †Community LA - NEB Market Share includes Retail + DME / Med B FFS through Jan’24. 8.6% 9.5% 10.8% 11.3% 11.6% 13.3% 12.4% 15.0% 15.2% 16.1% 16.7% 16.6% 0%
Slide 13: YUPELRI Retail Trends
13 Source: Symphony Health METYS Prescription Dashboard through Mar’24. TRx, Total Prescriptions; Rx, Prescriptions. - 2% ÛÚ Ï ß Ï Þ Ï á Ï â Ï ã Ï á Ï × ã Ï K 5 K 10 K 15 K 20 K 25 K 30 K 35 K Q1'22 Q2'22 Q3'22 Q4'22 Q1'23 Q2'23 Q3'23 Q4'23 Q1'24 YUPELRI Retail TRx YUPELRI Retail TRx YUPELRI Retail
Slide 14: YUPELRI Value Proposition
YUPELRI ® Value Proposition 14 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. As of March 31, 2024, Theravance Biopharma is eligible t
Slide 15: Financial Update
Financial Update Theravance Biopharma eo Medicines That Makea Difference
Slide 16: First Quarter 2024 Financials (Unaudited)
16 1. Amounts include share - based compensation. 2. Non - GAAP net profit (loss) from continuing operations consists of GAAP net loss before taxes excluding share - based compensati on expense and non - cash interest expense; see reconciliation on Slide 17 and the section titled "Non - GAAP Financi
Slide 17: First Quarter 2024 Financials (Cont'd)
First Quarter 2024 Financials (Unaudited) (Cont’d) 17 See the section titled "Non - GAAP Financial Measures" on Slide 2 for more information. GAAP Net Loss $ (11,664) $ (22,088) Adjustments: Share-based compensation expense 5,229 7,021 Non-cash interest expense 629 550 Income tax expense (benefit) 1
Slide 18: Q1 2024 Financial Highlights
Q1 2024 Financial Highlights Operating from a position of financial strength 18 1. Non - GAAP net profit (loss) from continuing operations consists of GAAP net income (loss) before taxes less share - based compen sation expense and non - cash interest expense; see reconciliation on Slide 17 and the
Slide 19: TRELEGY ELLIPTA Milestones and Royalties
Net Sales: Q1’24 of $749M, +32% Y/Y 2 Outer - Year Royalties 3 return in 2029: ▪ Ex - US royalties return Jul. 1, ௗ 2029 ▪ US royalties return after Jan. 1, ௗ 2031 ▪ Calculated on global net sales of eligible territories ▪ Share of royalties received equivalent to an upwardly tiered rate of 5.5 - 8.
Slide 20: TRELEGY Ellipta Sales Milestones
20 1. If both milestones are achieved in a given year, Theravance Biopharma will only earn the higher milestone. 2. GSK - reported Net Sales in USD. 3. Bloomberg Consensus as of 5/10/24. Theravance stands to receive up to $200 million in Trelegy sales milestones paid directly from Royalty Pharma. Th
Slide 21: 2024 Financial Guidance
2024 Financial Guidance 21 1. Non - GAAP net profit (loss) from continuing operations is expected to consist of GAAP net income (loss) before taxes less shar e - based compensation expense and non - cash interest expense; the section titled “Non - GAAP Financial Measures” on Slide 2 for more informa
Slide 22: Theravance's Strategic Focus
22 Theravance’s Strategic Focus • Grow YUPELRI in the United States; realize value through China expansion: • Drive U.S. hospital growth as part of overall brand maximization strategy • Achieve up to $150M in U.S. monotherapy sales milestones; first $25M for $250M of net sales in any given year • Re
Slide 23: Q&A Session
Rick Winningham Chairman and Chief Executive Officer Aziz Sawaf, CFA Senior Vice President, Chief Financial Officer Rhonda Farnum Senior Vice President, Chief Business Officer Áine Miller Senior Vice President, Development Q&A Session
Slide 24: YUPELRI (revefenacin) Inhalation Solution
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 25: 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 26: Appendix
Theravance WX Biopharma AK. Medicines That Make a Difference” Appendix
Slide 27: Appendix I: YUPELRI
Theravance WX Biopharma AK. Medicines That Make a Difference” Appendix I: YUPELRI®
Slide 28: Substantial Opportunity for Further YUPELRI Growth
28 Substantial Opportunity for Further YUPELRI ® Growth YUPELRI May Be Appropriate for ~2M Maintenance Patients in U.S. 1 1. Addressable patient population quantifies the number of patients within the intended target profile. 2. Estimated community patients on YUPELRI in 2023. Sources: Citeline Phar
Slide 29: YUPELRI Total Community & Retail TRx
29 × ß Ï ÛÜ Ï ß Ï à Ï × Ü Ï ã Ï ß Ï Ý Ï Ú Ï á Ï à Ï Ü Ï 30,000 50,000 70,000 Q1'21 Q2'21 Q3'21 Q4'21 Q1'22 Q2'22 Q3'22 Q4'22 Q1'23 Q2'23 Q3'23 Q4'23 Total Community TRx × Û Ï ÛÝ Ï ÛÚ Ï á Ï × Ü Ï ÛÚ Ï ß Ï Þ Ï á Ï â Ï ã Ï á Ï 10,000 20,000 30,000 40,000 Q1'21 Q2'21 Q3'21 Q4'21 Q1'22 Q2'22 Q3'22 Q4'22
Slide 30: Appendix II: Ampreloxetine
Theravance WX Biopharma AK. Medicines That Make a Difference” Appendix II: Ampreloxetine
Slide 31: Ampreloxetine Value Proposition
Ampreloxetine Value Proposition 31 1. “Estimating the prevalence and incidence of multiple system atrophy in the USA: Insights from a national claims database” , Parkinsonism and Related Disorders 11/4/2023; UC San Diego Dept. of Neurosciences (25K - 75K): https://neurosciences.ucsd.edu/centers - pr
Slide 32: MSA Prevalence in the United States: ~50K Patients
MSA Prevalence in the United States: ~50K Patients Recent Data C onfirm S ignificant P opulation with Unmet N eeds 1. Fanciulli A, Wenning GK. N Eng J Med 2015:372:249 – 63. 2. “Estimating the prevalence and incidence of multiple system atrophy in the USA: Insights from a national claims database” ,
Slide 33: Ampreloxetine Ex-U.S. Opportunity
33 1. Thelansis nOH Market Report 2023; TBPH Internal Analysis. nOH graphics reflect the mid - point of the provided ranges. 2. Prevalence estimate for Germany, France, UK, Italy and Spain. MSA, multiple system atrophy; nOH neurogenic orthostatic hypotension. Ampreloxetine Ex - U.S. Opportunity Sign
Slide 34: High Unmet Need in Symptomatic nOH in MSA
High Unmet Need in Symptomatic nOH in MSA Many Patients Suffer Debilitating Symptoms Without Adequate Therapy 1 . The Neurological Alliance, 2021/2022. 2 . Merola A, et al., Mov Disord 2018 . 3. Claassen DO, et al., BMC Neurol 2018. ME/CFS, m yalgic encephalomyelitis/chronic fatigue syndrome; MSA, m
Slide 35: Ampreloxetine Offers Unique Hope
Droxidopa Ampreloxetine Indication Symptomatic nOH in PD, PAF and MSA patients Symptomatic nOH in MSA patients [intended indication] Efficacy Durability OHSA#1(dizziness, lightheadedness only) Clinical effectiveness >2 weeks not established OHSA Composite (all six symptoms) Clinically meaningful and
Slide 36: High Probability of Technical Success
High Probability of Technical Success CYPRESS: Phase 3 randomized withdrawal (RWD) study in patients with MSA 36 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 37: Effective Treatment Requires Intact Peripheral Nerves
37 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 38: Demonstrated Durable, Clinically-significant Symptom Improvements in MSA Patients
38 BL, baseline; CI, confidence interval; MSA, multiple system atrophy; OHSA, orthostatic hypotension symptom assessment; RWD, r and omized withdrawal. Demonstrated Durable, Clinically - significant Symptom Improvements in MSA Patients 33 34 31 32 64 42 20 20 18 20 0 0 4 0 4 8 12 16 18 20 22 2 4 6 8
Slide 39: Increased Norepinephrine, Prevented Blood Pressure Drop in MSA Patients
Increased Norepinephrine, Prevented Blood Pressure Drop and Symptoms Worsening in MSA Patients 1, 2 39 1. Data from MSA patients. Error bars represent SE. * p < 0.05 comparison to baseline reported after 4 weeks of ampreloxetine ad ministration in study 0169. 2. Data from MSA patients at week 6 of t
Slide 40: Prevented Worsening of Standing SBP in MSA Patients
Data from MSA patients at week 6 of the randomized withdrawal period of study 0170. Standing SBP measured at 3 min and supine SB P measured at 10 min. Line represents the mean +/ - standard deviation. MSA, multiple system atrophy; SBP, systolic blood pressure; SD, standard deviation. Prevented Worse
Slide 41: Appendix III: Corporate
Theravance WX Biopharma AK. Medicines That Make a Difference” Appendix III: Corporate
Slide 42: Progress Against Financial Targets
42 1. 2024 Estimates assume mid - point of Guidance. Progress Against Financial Targets Reduction in Expense B ase C ombined with YUPELRI ® Net Sales Growth, and No D ebt $0 $50 $100 $150 $200 $250 $300 $350 ÜÚÜÛ ÜÚÜÜ ÜÚÜÝ 2024E R&D SG&A Share-Based Comp Severance & Restructuring Significant Expense
Slide 43: Granted Patent Protection Into Late 2030s
Granted Patent Protection Into Late 2030s 43 COPD, Chronic obstructive pulmonary disease ; nOH, neurogenic orthostatic hypotension; PTE, patent term extensions. Compound Invention Estimated Patent Expiry YUPELRI ® / revefenacin Composition of Matter 2028 (once PTE awarded) Polymorph 2030 - 2031 Meth
Slide 44: Viatris Collaboration Agreement Revenue
44 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