Theravance Biopharma, Inc. · NASDAQ:TBPH
Theravance Biopharma — Investor Presentation (January 2026)
62 slides from Theravance Biopharma's investor presentation, Jan 12, 2026
Slide 1: Theravance Biopharma Corporate Presentation January 2026
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.
Slide 2: Forward Looking Statements
2 Forward Looking Statements This presentation contains certain "forward - looking" statements as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding, among other things, statements relating to goals, plans, objectives, expectations and future events . Theravance B
Slide 3: Commercial-Stage Biotech Focused on Respiratory and Neurological Diseases
3 Commercial - Stage Biotech Focused on Respiratory and Neurological Diseases Strong Financial Position and Cash - Generating YUPELRI ® Set the Foundation for Near - Term Ampreloxetine Phase 3 Catalyst FDA, U.S. Food and Drug Administration; MSA, multiple system atrophy ; nOH, neurogenic orthostatic
Slide 4: Management team
4 Rick Winningham Chief Executive Officer Aziz Sawaf, CFA SVP, Chief Financial Officer Rhonda Farnum SVP, Chief Business Officer Áine Miller SVP, Development Leadership with Extensive Experience in Biotech
Slide 5: Ampreloxetine
5 AMPRELOXETINE The first once - daily, selective norepinephrine reuptake inhibitor in development to treat symptomatic neurogenic orthostatic hypotension ( nOH ) in patients with multiple system atrophy (MSA)
Slide 6: Multiple System Atrophy is a Rare and Severe Neurodegenerative Disease
6 Multiple System Atrophy (MSA) is a Rare and Severe Neurodegenerative Disease MSA is characterized by rapid neuronal loss leading to autonomic and motor failure 1. Fanciulli A, Wenning GK. Multiple - system atrophy. N Engl J Med. 2015;372(3):249 - 263. 2. Kalra DK, et al. Clin Med Insights: Cardiol
Slide 7: nOH is One of the Most Debilitating Features of MSA
7 Enabling the patient to maintain their ability to perform physical activities by treating nOH symptoms could be lifechanging nOH is One of the Most Debilitating Features of MSA with Severe Consequences 80% of patients with MSA experience nOH symptoms 1 MSA, multiple system atrophy; nOH , neurogeni
Slide 8: Patients with nOH due to MSA are Not Optimally Treated
8 Patients with nOH due to MSA are Not Optimally Treated High unmet need for a clinically meaningful treatment option remains MOA, mechanism of action; MSA, multiple system atrophy ; nOH , neurogenic orthostatic hypotension. 1. 150 board certified neurologists and 50 cardiologists were asked “Based
Slide 9: Ampreloxetine Intended to Target the Underlying Physiology of nOH in MSA
9 Ampreloxetine Intended to Target the Underlying Physiology of nOH in Patients with MSA Investigational, first - in - class 1 highly selective long - acting norepinephrine reuptake inhibitor ( NETi ) MSA, multiple system atrophy; nOH , neurogenic orthostatic hypotension. 1. Reflects Theravance Biop
Slide 10: OHSA is an FDA-Accepted Endpoint for Regulatory Approval
10 10 9 8 7 6 5 4 3 2 1 0 The Orthostatic Hypotension Symptom Assessment (OHSA) is an FDA - Accepted Endpoint for Regulatory Approval A 1 - point change is OHSA composite score is considered clinically meaningful 1 FDA, U.S. Food and Drug Administration; MSA, multiple system atrophy ; nOH , neurogen
Slide 11: Ampreloxetine Clinical Development
11 AMPRELOXETINE Clinical Development
Slide 12: Ampreloxetine Development Program Overview
12 Ampreloxetine Development Program Overview FDA, U.S. Food and Drug Administration; MSA, multiple system atrophy; NE, norepinephrine; NET, norepinephrine transporter; nOH , neurogenic orthostatic hypotension; QD, once a day; SBP, systolic blood pressure. 1. The initial Phase 3 program included the
Slide 13: Initial Phase Studies Enrolled Patients with MSA, Parkinson's and PAF
13 Initial Phase 3 Studies Enrolled Patients with MSA, Parkinson’s and PAF Purposefully enrolled higher percentage of patients MSA in REDWOOD (Study 0170) MSA, multiple system atrophy; OHSA, orthostatic hypotension symptom assessment; OL, open label; PAF, pure autonomic failure; PD, Parkinson’s dise
Slide 14: Mechanism of Action in MSA Patients Supported by Initial Phase 3 Studies
14 Mechanism of Action in MSA Patients Supported by Initial Phase 3 Studies BP, blood pressure; DHPG, dihydroxyphenylglycol ; LS, least - squares; MSA, multiple system atrophy; NE, norepinephrine, OHSA, orthostatic hypotension symptom assessment; SE, sta ndard error; SEM, standard error of mean. 1.
Slide 15: Consistent Symptom Benefits Across Individual OHSA Items in REDWOOD
15 Consistent Symptom Benefits Observed Across Individual OHSA Items in Patients with MSA in the Phase 3 REDWOOD Study 1 CI, confidence interval; LS, least squares; MSA, multiple system atrophy; OHDAS, orthostatic hypotension daily activity scale ; O HQ, orthostatic hypotension questionnaire; OHSA,
Slide 16: Durable, Clinically-Significant Symptom Benefit in REDWOOD
16 Ampreloxetine Demonstrated a Durable, Clinically - Significant Symptom Benefit in Patients with MSA in the Phase 3 REDWOOD Study 1 CI, confidence interval; DB, double - blind; MSA, multiple system atrophy; OHSA, orthostatic hypotension symptom assessment; OL, o pen label; RW, randomized withdrawa
Slide 17: Pivotal Phase 3 CYPRESS Trial Informed by REDWOOD
17 Pivotal Phase 3 CYPRESS Trial was Informed by REDWOOD Study Results in Patients with nOH due to MSA MSA, multiple system atrophy; nOH , neurogenic orthostatic hypotension; OHDAS, orthostatic hypotension daily activity scale; OHQ, orthostatic hypotension quest ion naire; OHSA, orthostatic hypotens
Slide 18: CYPRESS Design and Execution Optimizes Probability of Success
18 CYPRESS Design and Execution Optimizes Probability of Success Replicating the elements that led to the observed benefits in patients with MSA in the REDWOOD study KOL, key opinion leader; MSA, multiple system atrophy; OHSA, orthostatic hypotension symptom assessment . CYPRESS protocol leverages l
Slide 19: CYPRESS Topline Readout will Provide an Extensive Data Set
19 CYPRESS Topline Readout will Provide an Extensive Data Set CYPRESS study replicated the elements that led to the observed benefits in patients with MSA in the REDWOOD study Population • Patient disposition: status during OL and RW • Baseline characteristics: demography, clinical characteristics a
Slide 20: Positioned to Capitalize Rapidly Upon Potential Positive CYPRESS Readout
20 Positioned to Capitalize Rapidly Upon Potential Positive Readout from Pivotal Phase 3 CYPRESS Trial FDA, U.S. Food and Drug Administration; NDA, new drug application. Alignment with FDA achieved; NDA preparations underway NDA Readiness Completed enrollment in Q3 2025; open - label portion now com
Slide 21: Ampreloxetine Market Opportunity
21 AMPRELOXETINE Market Opportunity
Slide 22: Concentrated, Rare Neurology Market with Potential Therapeutic Breakthrough
22 Concentrated, Rare Neurology Market with Potential Therapeutic Breakthrough High Potential Adoption Value of Innovation Addressable Patients • Potential to be first therapy to deliver durable, clinically meaningful improvement in nOH in patients with MSA • Chronic neurology orphan therapies comma
Slide 23: ~40,000 Patients with MSA Suffer from Symptomatic nOH in the U.S.
23 ~40,000 Patients with MSA Suffer from Symptomatic nOH in the U.S. MSA is underdiagnosed and often misdiagnosed 1 - 3 ~80% have symptomatic nOH 4,5 ~40K with symptomatic nOH ~50K Patients w/ MSA 6,8,9 Estimated patient population for symptomatic nOH due to MSA in the U.S. Epidemiology supported by
Slide 24: Significant Commercial Opportunity Given Available Treatments
24 Significant Commercial Opportunity for Ampreloxetine Given Available Treatments MSA, multiple system atrophy; nOH , neurogenic orthostatic hypotension; OHSA, orthostatic hypotension symptom assessment. 1. Veeva Compass patient - level claims data, MSA patients (G90.3) with at least 1 Rx from 2020
Slide 25: Opportunity to Address Significant Unmet Need in nOH
25 Ampreloxetine has an Opportunity to Address the Significant Unmet Need In nOH Treatment with its Unique Target Product Attributes HCP, healthcare professional; MSA, multiple system atrophy; nOH , neurogenic orthostatic hypotension. 1. N=200 board certified neurologists (n=150) and cardiologists (
Slide 26: Targeted Launch Plan Leverages Concentrated MSA Treatment Landscape
26 Targeted Launch Plan Leverages Concentrated MSA Treatment Landscape MSA, multiple system atrophy. 1. Veeva Compass patient - level claims data, MSA patients (G90.3), 2022 - 2024. 2. Centers of Excellence: https://missionmsa.org/re source - library/centers - of - excellence - overview/, https://ww
Slide 27: Payers Acknowledge High Burden and Large Unmet Need
27 Payers Acknowledge its High Burden and Large Unmet Need for Novel Treatments CVL, covered lives; MSA, multiple system atrophy; nOH , neurogenic orthostatic hypotension. Source: Trinity Pre - Topline Ampreloxetine Pricing and Demand Opportunity Assessment June 2025 (N=10 Payers). Disease Burden Pe
Slide 28: Premium Value Opportunity Driven by Unmet Need and Clinical Impact
28 Premium Value Opportunity Driven by Unmet Need and Clinical Impact Rare Disease Launches (’21 - ’24) 1 Average launch price ($K) for chronic therapies by therapeutic area (n=52) $579 $399 $396 $355 $337 $333 $310 $255 Metabolism (n=9) Immunology (n=10) Hepatology (n=1) Musculoskeletal (n=6) Derma
Slide 29: Market Opportunity for Ampreloxetine in Europe and Asia
29 Meaningful Market Opportunity for Ampreloxetine Exists in Europe and Asia Patients with MSA Patients with nOH due to MSA Patients with MSA Patients with nOH due to MSA • 28 CYPRESS study sites in EU • Existing relationships with KOLs and patient advocacy groups • Will seek EMA scientific advice/
Slide 30: Ampreloxetine US Intellectual Property Summary
30 Subject Matter Orphan Drug Designation Molecule Method of Treatment Ampreloxetine US Intellectual Property Summary PTE is patent term extension. LOE estimates based only on US patents. Ex - US patents have been filed but are not shown here. • * March 2043 represents the base term; may be eligible
Slide 31: Ampreloxetine: Potential to Transform Care in a Rare and Debilitating Disease
31 Ampreloxetine: Potential to Transform Care in a Rare and Debilitating Disease FDA, U.S. Food and Drug Administration; MSA, multiple system atrophy; nOH, neurogenic orthostatic hypotension. Addresses rare neurological disorder with high unmet need De - risked Phase 3 program designed with FDA alig
Slide 32: The Only Once-Daily, Nebulized LAMA Maintenance Medicine for COPD
32 COPD, chronic obstructive pulmonary disease; LAMA, long - acting muscarinic antagonist. The Only Once - Daily, Nebulized LAMA Maintenance Medicine for COPD
Slide 33: Nebulized Maintenance Therapy: A Critical Treatment Option in COPD
33 Nebulized Maintenance Therapy: A Critical Treatment Option in COPD COPD, chronic obstructive pulmonary disease; FFS, Fee For Service; LAMA, long - acting muscarinic antagonist. 1. Donahue, 2019. 2. Avalere, 2024. YUPELRI is contraindicated in patients with hypersensitivity to revefenacin or any c
Slide 34: YUPELRI Opportunity: Expand Use of Neb LAMA in ~1.9M COPD Patients
34 YUPELRI Opportunity: Expand Use of Neb LAMA in ~1.9M Patients with COPD 1 COPD, chronic obstructive pulmonary disease; LABA, long - acting beta agonist; LAMA, long - acting muscarinic antagonist; Neb, nebul ized therapy. 1. Addressable patient population quantifies the number of patients within
Slide 35: Theravance / Viatris Partnership Drives YUPELRI Prescription Growth
35 Theravance / Viatris Partnership Drives YUPELRI Prescription Growth U.S. Co - Promotion Agreement (35% / 65% Profit Share) Community (Doctor’s Office) Hospital MD starts YUPELRI Community MD starts YUPELRI Patients continue YUPELRI YUPELRI candidate experiences symptoms or exacerbation Fulfillm
Slide 36: Continued Year-over-Year YUPELRI Net Sales Growth in the U.S.
36 $60.6 $55.2 $54.5 $62.2 $66.7 $58.3 $66.3 $71.4 0 10 20 30 40 50 60 70 80 Q4'23 Q1'24 Q2'24 Q3'24 Q4'24 Q1'25 Q2'25 Q3'25 Quarterly YUPELRI Net Sales (Trailing Eight Quarters) Continued Year - over - Year YUPELRI ® Net Sales Growth in the U.S. In the US, Viatris is leading the commercialization o
Slide 37: Strong Q3 Performance and Expanding YUPELRI Profitability
37 Strong Q3 Performance and Expanding YUPELRI ® Profitability LABA, long - acting beta agonist; LAMA, long - acting muscarinic antagonist. 1. Joint VTRS/TBPH Market Research. 2. Addressable patient population quantifies the number of patients within the intended t arg et profile. Source: Joint VTRS
Slide 38: Granted Patent Protection into Late 2030s
38 Granted Patent Protection into Late 2030s Patent Expiry Invention Compound 2028 Composition of Matter YUPELRI ® / revefenacin 2030 - 2031 Polymorph 2039 Method for the maintenance treatment of COPD patients • Total of 7 generics filed ANDAs in November 2022, with 1 subsequent filer • Litigation s
Slide 39: Milestones from Royalty Pharma: GSK's TRELEGY
39 GSK’s TRELEGY COPD, chronic obstructive pulmonary disease The First and Only Once - Daily Triple Therapy in a Single Inhaler for Adult Patients with COPD or Asthma Milestones from Royalty Pharma
Slide 40: On Pace to Achieve $150M in TRELEGY Sales Milestones in 2025 and 2026
40 On Pace to Achieve $150M in TRELEGY Sales Milestones in 2025 and 2026 Q3’25 Net Sales of $1.0B and YTD Net Sales of $2.9B, up 13% YoY 1. If both milestones are achieved in a given year, Theravance Biopharma will only earn the higher milestone, payable by Royalty Pharma (RP) pursuant to the Equity
Slide 41: Financials and Capital Management
41 Financials and Capital Management
Slide 42: Third Quarter 2025 Financial Highlights
42 Third Quarter 2025 Financial Highlights SBC, Share - Based Compensation. 1. Non - GAAP net income (loss) consists of GAAP net income (loss) before taxes less (i) share - based compensation expense; (ii) no n - cash interest expense; (iii) non - cash impairment expense; and (iv) non - recurring re
Slide 43: Reaffirmed Operating Expense Guidance with Improved Margin Outlook
43 1. Non - GAAP net loss consists of GAAP net income (loss) before taxes less ( i ) share - based compensation expense; (ii) non - cash interest expense; (iii) non - cash impairment expense; and (iv) non - recurring revenue and income items; see reconciliation on Slide 17 and the section titled "No
Slide 44: Commercial-Stage Biotech Focused on Respiratory and Neurological Diseases
44 Commercial - Stage Biotech Focused on Respiratory and Neurological Diseases Strong financial position and cash - generating YUPELRI ® set the foundation for near - term Phase 3 catalyst FDA, U.S. Food and Drug Administration; MSA, multiple system atrophy ; nOH , neurogenic orthostatic hypotension
Slide 45: Appendix
45 Appendix
Slide 46: Third Quarter 2025 Financials (Unaudited)
46 Third Quarter 2025 Financials (Unaudited) 1. Amounts include share - based compensation. 2. Non - GAAP net income (loss) consists of GAAP net income (loss) before taxes exclu ding (i) share - based compensation expense; (ii) non - cash interest expense; (iii) non - cash impairment expense; and (i
Slide 47: Third Quarter 2025 Financials (Unaudited) (Cont'd)
47 Third Quarter 2025 Financials (Unaudited) (Cont’d) 47 See the section titled "Non - GAAP Financial Measures" on Slide 2 for more information. GAAP Net Income (Loss) $ 3,615 $ (12,698) $ 44,871 $ (40,891) Adjustments: Licensing revenue (1) - - (7,500) - Net gain on realized contingent milestone an
Slide 48: Appendix
Appendix COPD, chronic obstructive pulmonary disease; LAMA, long - acting muscarinic antagonist.
Slide 49: YUPELRI (revefenacin) Inhalation Solution
49 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 a
Slide 50: About YUPELRI (revefenacin) Inhalation Solution
50 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
Slide 51: YUPELRI Delivers Efficacy in a Single, Nebulized Daily Dose
51 YUPELRI Delivers a Full 24 Hours of Efficacy in a Single, Nebulized Daily Dose 1 FEV1, forced expiratory volume in one second; LS, least squared. 1. YUPELRI [package insert]. Morgantown, WV: Mylan Specialty LP; 2. YUPELRI was studied in two 12 - week, randomized, double - blind , placebo - cont
Slide 52: Comparison of Yupelri, Dupixent, and Ohtuvayre in COPD Treatment
52 Comparison of Yupelri , Dupixent, and Ohtuvayre in COPD Treatment COPD, chronic obstructive pulmonary disease; FDA, U.S. Food and Drug Administration; LABA, LAMA, long - acting muscarinic antagonist; LABA, long - acting beta agonist. Source: 2025 GOLD Report, Prescribing Info Ohtuvayre ( ensifent
Slide 53: Ampreloxetine Appendix
53 AMPRELOXETINE Appendix
Slide 54: Recent Publications and Presentations Highlight Durable Symptom Benefit
54 Recent Publications and Presentations Highlight Durable Symptom Benefit Observed in Previous REDWOOD/0170 Study in MSA Patients 1 AAS, American Autonomic Society; MSA, multiple system atrophy. 1. Ampreloxetine is in development and not approved for any indication. No conclusion can be drawn regar
Slide 55: Increase in Standing Blood Pressure Correlated with Symptom Improvement
55 Ampreloxetine Increase in Standing Blood Pressure Correlated with Improvement in Symptoms and Daily Activities in Patients with MSA in the REDWOOD/0170 Study 1 MSA, multiple system atrophy; OHDAS, orthostatic hypotension daily activity scale; OHSA, orthostatic hypotension symptom assessment; RW,
Slide 56: Ampreloxetine is a Potent and Selective Norepinephrine Reuptake Inhibitor
56 Ampreloxetine is a Potent and Selective Norepinephrine Reuptake Inhibitor (NRI) 5 - HT, serotonin; DA, dopamine; NE, norepinephrine. Smith JA, et al. Int J Neuropsychopharmacol . 2014;18(2):pyu027. Hegde S et al. 2018 International Congress of Parkinson’s Disease and Movement Disorders. Abstract
Slide 57: Ampreloxetine Preferentially Improved Standing Systolic Blood Pressure in MSA
57 Ampreloxetine Preferentially Improved Standing Systolic Blood Pressure in MSA Data from randomized withdrawal period in Study 0170 LS, least squares; mmHg, millimeters of mercury; MSA, multiple system atrophy; PAF, pure autonomic failure; PD, Parkinson’s D ise ase; SE, standard error. Data taken
Slide 58: Ampreloxetine Improved Upright Blood Pressure Physiologically
58 Ampreloxetine Improved Upright Blood Pressure “Physiologically” Data from MSA patients at week 6 of the randomized withdrawal period of study 0170 MSA, multiple system atrophy; SBP, systolic blood pressure; SD, standard deviation. Data from MSA patients at week 6 of the randomized withdrawal peri
Slide 59: Study 0170 Randomized Withdrawal Period: Overall Disposition
59 Study 0170 Randomized Withdrawal Period: Overall Disposition Low frequency of discontinuations overall o Only two discontinuations for adverse events – one each in placebo and ampreloxetine groups Total (n = 128) Ampreloxetine (n = 64) Placebo (n = 64) 119 (93.0) 58 (90.6) 61 (95.3) Completed tre
Slide 60: Study 0170 Randomized Withdrawal Period: AE Summary
60 Study 0170 Randomized Withdrawal Period: AE Summary Randomized withdrawal period o TEAEs were similar between placebo and ampreloxetine group o No adverse events of supine hypertension were observed o No clinically significant differences for laboratory parameters, ECG changes, ambulatory BP moni
Slide 61: AEs in MSA Subgroup: Randomized Controlled Phases of Studies 0169 and 0170
61 AEs in MSA Subgroup: Randomized Controlled Phases of Studies 0169 and 0170 Ampreloxetine appears safe and well - tolerated in MSA patients o Overall, the AE profile was similar between placebo and ampreloxetine groups during the randomized controlled phases o Only 2 SAEs considered related to stu
Slide 62: MSA Patients with nOH Suffer Worse Symptom Burden and Daily Functioning
62 MSA Patients with nOH Suffer Worse Symptom Burden and Daily Functioning Study 0169 Analysis Presented at AAS o Amongst patients with α - synucleinopathies , MSA patients reported the highest symptom burden, most severe impact to activities of daily living and worst quality of life , despite treat
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