Theravance Biopharma, Inc. · NASDAQ:TBPH
Theravance Biopharma — FY2023 Earnings Presentation
42 slides from Theravance Biopharma's earnings presentation, Feb 26, 2024
Slide 1: Fourth Quarter & Full Year 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 Bio
Slide 3: Agenda
Introduction Rick Winningham Chief Executive Officer Ampreloxetine Overview Rick Winningham Chief Executive Officer Áine Miller Senior Vice President, Development YUPELRI ® Update Rhonda Farnum Senior Vice President, Chief Business Officer Financial Update Aziz Sawaf Senior Vice President, Chief Fin
Slide 4: 2023 Year-End Highlights
2023 YearEnd Highlights41. In the US,Viatris is leading the commercialization of YUPELRI, and Theravance Biopharma co promotes the product under a profit and loss sharing a rrangement (65% to Viatris ; 35% to Theravance2Non GAAP net profit (loss) from continuing operations consists of GAAP net incom
Slide 5: 2024 Strategic Objectives
2024 Strategic Objectives 5 1 . Non - GAAP net profit (loss) from continuing operations is expected to consist of GAAP net income (loss) before taxes less share - based compensation expense and non - cash interest expense. See the section titled "Non - GAAP Financial Measures" on Slide 2 for more in
Slide 6: 1. In the US, Viatris is leading the commercialization of YUPELRI, and Theravance Biopharma
6 1. In the US, Viatris is leading the commercialization of YUPELRI, and Theravance Biopharma co - promotes the product under a profit and loss sharing a rrangement (65% to Viatris ; 35% to Theravance Biopharma). 2 . As of December 31, 2023 . 3 . As of December 31, 2023, Theravance Biopharma is elig
Slide 7: Ampreloxetine
Ampreloxetine Investigational once - daily norepinephrine reuptake inhibitor For symptomatic neurogenic orthostatic hypotension (nOH) in multiple system atrophy (MSA) patients
Slide 8: Ampreloxetine Value Proposition
Ampreloxetine Value Proposition 8 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 - pro
Slide 9: MSA Prevalence in the United States: ~50K Patients
MSA Prevalence in the United States: ~50K PatientsRecent Data C onfirm S ignificant P opulation with Unmet N eeds1. 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", Parki
Slide 10: Ampreloxetine Ex-U.S. Opportunity
10 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 11: High Unmet Need in Symptomatic nOH in MSA
High Unmet Need in Symptomatic nOH in MSAMany Patients Suffer Debilitating Symptoms Without Adequate Therapy1. The Neurological Alliance, 2021/2022.2. Merola A, et al., Mov Disord 2018.3. Claassen DO, et al., BMC Neurol 2018.ME/CFS, myalgic encephalomyelitis/chronic fatigue syndrome; MSA, multiple s
Slide 12: 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 13: Phase 3 CYPRESS Study Update
Phase 3 CYPRESS Study Update Maximizing the Probability of Clinical and Regulatory Success 13 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 14: YUPELRI
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 15: YUPELRI Continued Net Sales Growth
YUPELRI ® Continued Net Sales Growth 15 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). $9.1 $16.5 $29.6 $36.8 $30.3 $37.0 $38.7 $36.9 $41.8 $
Slide 16: Theravance Hospital Execution Drives Value
Theravance Hospital Execution Drives Value 16 1. Source: IQVIA DDD, HDS, VA and Non - Reporting Hospital through 12/31/2023. Preliminary data subject to revision upon receipt o f final data. 10K 19K 30K 54K 34K 47K 54K 56K 70K 78K 93K 98K 108K 113K 138K 160K 156K 160K 189K 0K 20K 40K 60K 80K 100K 12
Slide 17: YUPELRI Market Share Gains Continue
YUPELRI ® Market Share Gains Continue 17 1. Joint VTRS/TBPH Market Research (Aug’23). * Hospital LA - NEB Market Share - IQVIA DDD through Dec’23. †Community LA - NEB Market Share includes Retail + DME / Med B FFS through Nov’23. 7.8% 8.7% 9.5% 10.8% 11.3% 11.7% 13.3% 12.5% 14.9% 15.1% 16.0% 16.6% 0
Slide 18: YUPELRI Total Community Retail TRx Track Directionally
188%-5%12%5%6% -2%9%5% 3% 0%7%6%30,00050,00070,000Q4'20 Q1'21 Q2'21 Q3'21 Q4'21 Q1'22 Q2'22 Q3'22 Q4'22 Q1'23 Q2'23 Q3'23Total Community TRx10% -1%13%10%7% -2%10%5% 4%7%8%9%10,00020,00030,000Q4'20 Q1'21 Q2'21 Q3'21 Q4'21 Q1'22 Q2'22 Q3'22 Q4'22 Q1'23 Q2'23 Q3'23o'Total Community' includesRetail + DM
Slide 19: YUPELRI Retail Trends
19 Source: Symphony Health METYS Prescription Dashboard through Dec’23. TRx , Total Prescriptions. 7% - 2% 10% 5% 4% 7% 8% 9% 7% K 5 K 10 K 15 K 20 K 25 K 30 K 35 K Q4'21 Q1'22 Q2'22 Q3'22 Q4'22 Q1'23 Q2'23 Q3'23 Q4'23 YUPELRI Retail TRx YUPELRI Retail TRx YUPELRI Retail TRx YUPELRI ® Retail Trends
Slide 20: YUPELRI Value Proposition
YUPELRI ® Value Proposition 20 1. In the US, Viatris is leading the commercialization of YUPELRI, and Theravance Biopharma co - promotes the product under a profit and loss sharing a rrangement (65% to Viatris ; 35% to Theravance Biopharma). 2. As of December 31, 2023, Theravance Biopharma is eligib
Slide 21: Financial Update
Financial Update Theravance sk Biopharma AX Medicines Tot Make aDiference
Slide 22: Fourth Quarter 2023 Financials (Unaudited)
22 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 compensation expense and non - cash interest expense; see reconciliation on Slide 23 and the section titled "Non - GAAP Financial
Slide 23: Fourth Quarter 2023 Financials (Cont'd)
Fourth Quarter 2023 Financials (Unaudited) (Cont’d) 23 See the section titled "Non - GAAP Financial Measures" on Slide 2 for more information. GAAP Net Loss from Continuing Operations $ (8,511) $ (14,258) $ (55,193) $ (92,824) Adjustments: Share-based compensation expense 5,825 6,948 25,371 39,734 N
Slide 24: Q4 2023 Financial Highlights
Q4 2023 Financial Highlights Significant Capital Returns from a Position of Strength 24 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 23
Slide 25: TRELEGY ELLIPTA Milestones and Royalties
Net Sales: Q4'23 of $737M, +35% YoY; FY'23 of $2,739M, +28% YoY2OuterYear Royalties 3 return in 2029:?ExUS 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 upwardlytiered rate of 5.
Slide 26: 2024 Financial Guidance
2024 Financial Guidance 26 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 27: Theravance's Strategic Focus
27 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 28: 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 29: YUPELRI Important Safety Information
YUPELRI revefenacin ) Inhalation SolutionYUPELRI inhalation solution is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (ImportantSafety Information (YUPELRIis contraindicated in patients with hypersensitivity to revefenacin or any component of this pro
Slide 30: 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 n
Slide 31: Appendix
Theravance kX Biopharma AR. Medicines That Make a Difference” Appendix
Slide 32: Appendix I: YUPELRI
Theravance kK Biopharma AK. Medicines That Make a Difference” Appendix |: YUPELRI®
Slide 33: Substantial Opportunity for Further YUPELRI Growth
33Substantial Opportunity for Further YUPELRI GrowthYUPELRI May Be Appropriate for ~2M Maintenance Patients in U.S. 11. Addressable patient population quantifies the number of patients within the intended target profile.2. Estimated community patients on YUPELRI in 2023.Sources:Citeline Pharma Custo
Slide 34: Appendix II: Ampreloxetine
Theravance kK Biopharma AK. Medicines That Make a Difference” Appendix II: Ampreloxetine
Slide 35: Effective Treatment Requires Intact Peripheral Nerves
35 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 36: Demonstrated Durable, Clinically-significant Symptom Improvements in MSA Patients
36 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 37: Increased Norepinephrine, Prevented Blood Pressure Drop and Symptoms Worsening
Increased Norepinephrine, Prevented Blood Pressure Drop and Symptoms Worsening in MSA Patients 1, 2 37 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 38: 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 39: Appendix III: Corporate
Theravance kX Biopharma AR. Medicines That Make a Difference” Appendix III: Corporate
Slide 40: Progress Against Financial Targets
401. 2024 Estimates assume midpoint of Guidance.Progress Against Financial TargetsReduction in Expense B ase C ombined with YUPELRI Net Sales Growth, and No Debt$0$50$100$150$200$250$300$3502021 2022 2023 2024ERD SGAShare-Based Comp Severance RestructuringSignificant Expense Reductions$ millions$ mi
Slide 41: Granted Patent Protection Into Late 2030s
Granted Patent Protection Into Late 2030s 41 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 42: Viatris Collaboration Agreement Revenue
42 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