Theravance Biopharma, Inc. · NASDAQ:TBPH
Theravance Biopharma — Investor Presentation (September 2024)
47 slides from Theravance Biopharma's investor presentation, Sep 10, 2024
Slide 1: Theravance Biopharma Investor Presentation September 2024
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: Theravance Biopharma – Medicines That Make a Difference
3 Theravance Biopharma – Medicines That Make a Difference YUPELR I – First - in - class nebulized long - acting muscarinic antagonist (LAMA) for chronic obstructive pulmonary disease (COPD) Ampreloxetine – Potential first - in - class therapy targeting neurogenic orthostatic hypotension ( nOH )
Slide 4: Revenue Generating and Late-Stage Assets
4 Partner and Economic Interest Marketed NDA Filed Pivotal Development Indication Co - promote: 35% of profits to Theravance COPD YUPELRI US US launch 2019 Milestones, 14 - 20% royalties COPD YUPELRI China NDA filed June 2024 100% Commercial Rights 1 nOH in MSA Ampreloxetine CYPRESS Pivotal LPI Mid
Slide 5: Catalysts and Value Generating Milestones
5 5 Catalysts and Value Generating Milestones Date Value Catalyst Product TBD (LTM = $229M) $25M Milestone for 1 st year in which US net sales > $250M TBD (NDA submitted June 2024) $7.5M Milestone for NDA approval in China in COPD Mid - 2025 -- Last patient enrolled in Registrational Phase 3 CYPRESS
Slide 6: The Only Once-Daily, Nebulized LAMA Maintenance Medicine for COPD
The Only Once - Daily, Nebulized LAMA Maintenance Medicine for COPD LAMA, long - acting muscarinic antagonist; COPD, chronic obstructive pulmonary disease
Slide 7: COPD Remains a Serious Respiratory Condition with Unmet Needs
7 Symptoms include difficulty breathing, coughing, wheezing, chest tightness and fatigue 7 COPD Remains a Serious Respiratory Condition with Unmet Needs 1. CDC, 2023, NIH. ICS, inhaled corticosteroid; LABA, long - acting beta agonist; LAMA, long - acting muscarinic antagonist. Chronic Obstructive Pu
Slide 8: Nebulized Maintenance Therapy: An Important Treatment Option in COPD
8 Nebulized therapy is an important alternative for many COPD patients 8 Nebulized Maintenance Therapy: An Important Treatment Option in COPD 1. CDC, 2023, NIH. 2. Addressable patient population quantifies the number of patients within the intended target profile. So urc es: Citeline Pharma Custom I
Slide 9: YUPELRI Delivers a Full 24 Hours of Efficacy in a Single Daily Dose
9 YUPELRI Delivers a Full 24 Hours of Efficacy in a Single, Nebulized Daily Dose 1 1. YUPELRI [package insert]. Morgantown, WV: Mylan Specialty LP; 2. YUPELRI was studied in two 12 - week, randomized, double - blind, placebo - controlled, parallel - group confirmatory studies (Studies 1 and 2) to
Slide 10: YUPELRI Opportunity: Expand Use of Neb LAMA in ~1.9M COPD Patients
10 YUPELRI Opportunity: Expand Use of Neb LAMA in ~1.9M COPD Patients 1 1. Addressable patient population quantifies the number of patients within the intended target profile. Source: Joint VTRS/TB PH Market Research (Jun’24). 2. Global Initiative for Chronic Obstructive Lung Disease 2024 Report.
Slide 11: Theravance / Viatris Partnership Drives YUPELRI Prescription Growth
11 Theravance / Viatris Partnership Drives YUPELRI Prescription Growth US Co - Promotion Agreement (35% / 65% Profit Share) Community (Doctor’s Office) Hospital MD starts YUPELRI Community MD starts YUPELRI Hospital starts make a sizeable contribution to the business • >80% of patients receiving Y
Slide 12: Strong US Hospital Execution Drives Value Creation
12 Strong US Hospital Execution Drives Value Creation 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 226K 0K 50K 100K 150K
Slide 13: YUPELRI US Net Sales Performance
13 YUPELRI ® US Net Sales Performance 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 $39.4 $
Slide 14: The YUPELRI China Opportunity
14 The YUPELRI ® China Opportunity NDA Filed June 2024 Viatris is the 8 th largest multinational company in China, with a sales force of ~4,200 covering >70K hospitals and 400K pharmacies in over 300 cities 5 #2 pharmaceutical market globally 1 Nearly 100M individuals with COPD; ~43% suffer from mod
Slide 15: YUPELRI Value Proposition
15 Once - Daily Nebulized LAMA COPD Maintenance Medicine o Last twelve m onths ’ US sales up 8% to $229M; Theravance receives 35% of US profits 1 o Brand profitable, with expanding profit margins o Medicare Part B therapy; FFS beneficiaries with supplemental insurance face out - of - pocket costs as
Slide 16: Ampreloxetine
The first NET inhibitor in development exclusively to treat symptoms of nOH in MSA NET, norepinephrine transporter; nOH , neurogenic orthostatic hypotension ; MSA, multiple system atrophy AMPRELOXETINE
Slide 17: Multiple System Atrophy: A progressive neurological disorder
17 Multiple System Atrophy (MSA): A progressive neurological disorder leading to autonomic failure and neurogenic orthostatic hypotension ( nOH ) Sources: Biorender.com. In MSA , abnormal deposits of mis - folded - synuclein are associated with progressive neuro - degeneration Neuro - degeneration
Slide 18: Neurogenic Orthostatic Hypotension: One of the Most Devastating Consequences of MSA
18 Neurogenic Orthostatic Hypotension ( nOH ): One of the Most Devastating Consequences of MSA 1. 203202ORIG1S000 - FDA, www.accessdata.fda.gov/drugsatfda_docs/nda/2014/203202Orig1s000SumR.pdf. Accessed 8 Sept. 2024. 2. Kau fmann H. (2023, November 15 - 18). Evaluating clinically meaningful changes
Slide 19: Ampreloxetine Intended to Increase Norepinephrine and Treat nOH
19 Ampreloxetine Intended to Increase Norepinephrine and Treat nOH Post - ganglionic sympathetic nerve Pre - ganglionic sympathetic nerve Autonomic ganglia NE Post - ganglionic Sympathetic Nerve ending NET NE VMAT Effector Cell NET Sympathetic activity ( NE released into the synapse) stimulates adre
Slide 20: Ampreloxetine MoA Supported by MSA Patient Data
20 Ampreloxetine MoA Supported by MSA Patient Data 1, 2 1. Data from MSA patients. Error bars represent SE. * p < 0.05 comparison to baseline reported after 4 weeks of ampreloxetine administration in study 0169. 2. Data from MSA patients at week 6 of the randomized withdrawal period of study 0170. A
Slide 21: The Unmet Need in MSA Patients with nOH is High
21 The Unmet Need in MSA Patients with nOH is High 1. Claassen D.O., Adler C.H., Hewitt L.A., Gibbons C. (2018), BMC Neurology, 18 (1), art. no. 125. MSA, multiple system atrophy; nOH neurogenic orthostatic hypotension. Advocacy groups, patients and caregivers are actively engaged and seeking new th
Slide 22: MSA Patients with nOH are Not Optimally Treated
22 MSA Patients with nOH are Not Optimally Treated Clinically meaningful options are needed 1. MSA Natural History Statistics, NYU September 2019. 2. Veeva Compass patient - level claims data, MSA patients (G90.3) with at least 1 Rx from 2020 - 2023. Product share defined as total “days supplied” in
Slide 23: Clinical Development Ampreloxetine
Clinical Development AMPRELOXETINE
Slide 24: Study 0170 (REDWOOD) Enrolled MSA, Parkinson's and PAF Patients
24 Study 0170 (REDWOOD) Enrolled MSA, Parkinson’s and PAF Patients 1. Study 0170 was terminated early because of negative results from Study 0169 (n=128 vs. 154 anticipated). MSA, multiple system atrophy; OHSA, orthostatic hypotension symptom assessment; OL, open label; PAF, pure autonomic failure;
Slide 25: Durable, Clinically-Significant Symptom Improvements Seen in MSA Patients
25 Durable, Clinically - Significant Symptom Improvements Seen in MSA Patients CI, confidence interval; DB, double - blind; MSA, multiple system atrophy; OHSA, orthostatic hypotension symptom assessment; OL, o pen label; RW, randomized withdrawal. BL1 2 3 4 0 2 4 6 8 BL 4 8 12 16 BL 18 20 22 time (w
Slide 26: Consistent Symptom Benefits Across Individual OHSA Items in MSA Patients
26 Consistent Symptom Benefits Across Individual OHSA Items in MSA Patients Data from MSA patients at week 6 of the randomized withdrawal period of study 0170; individual item score analyses are post - hoc, except for dizziness. CI, confidence interval; LS, least squares; MSA, multiple system atroph
Slide 27: Alignment with FDA on CYPRESS Trial Design and Regulatory Approach
27 Alignment with FDA on CYPRESS Trial Design and Regulatory Approach 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]. OHSA, orthostatic hyp
Slide 28: CYPRESS Designed to Reproduce Study 0170 MSA Patient Results
28 CYPRESS Designed to Reproduce Study 0170 MSA Patient Results MSA, multiple system atrophy; nOH , neurogenic orthostatic hypotension; OHSA, orthostatic hypotension symptom assessment; RW, randomized withdrawal. Entry Endpoint 8 - week double blind RW 12 - week open - label Baseline Randomization A
Slide 29: Market Opportunity Ampreloxetine
Market Opportunity AMPRELOXETINE
Slide 30: Ampreloxetine Global Opportunity
30 Prevalence in Europe 1,2 45 - 60K MSA Patients with nOH Prevalence in China & Japan 1 90 - 105K MSA Patients with nOH Ampreloxetine Global Opportunity Significant unmet needs in leading therapeutics markets 1. Thelansis nOH Market Report 2023; TBPH Internal Analysis. nOH graphics reflect the mid
Slide 31: Concentrated Treatment Landscape, Centered on MSA, nOH Specialists
31 Concentrated Treatment Landscape, Centered on MSA, nOH Specialists 1. Centers of Excellence: https://missionmsa.org/resource - library/centers - of - excellence - overview/ , https://www.psp.org/centers - of - care 2. Veeva Compass patient - level claims data, MSA patients (G90.3), 1/1/2023 - 12/
Slide 32: Ampreloxetine Value Proposition in MSA with nOH
32 Ampreloxetine Value Proposition in MSA with nOH Potential best - in - class agent with orphan drug disease designation 1 o Once - daily dosing with durable, clinically meaningful efficacy in target population o No observed supine hypotension further distinguishes from competitive landscape o MOA
Slide 33: TRELEGY
The only once - daily, 3 - in - 1 treatment for COPD or asthma TRELEGY COPD, chronic obstructive pulmonary disease
Slide 34: TRELEGY Milestones and Royalties Represent Added Value
34 TRELEGY Milestones and Royalties Represent Added Value 1. As of 06/30/24, Theravance stands to receive up to $200 million in TRELEGY sales milestones paid directly from Royalty Pharma (RP). In each year from 20 24 to 2026, a first payment will be triggered if RP receives a minimum royalty payment
Slide 35: $200M in Potential TRELEGY Sales Milestones if Upper Tier Thresholds are Met
35 $200M in Potential TRELEGY Sales Milestones if Upper Tier Thresholds are Met 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. GSK - reported Net Sales in USD. 4. Bloomberg Consensus as o
Slide 36: Global TRELEGY Royalties to Return Beginning in 2029
36 Global TRELEGY Royalties to Return Beginning in 2029 1. Eligibility generally ends 15 years after first launch in an eligible territory: U.S. royalties are expected to end late 2 032 , while ex - U.S. royalties are expected to end in the mid - 2030s on a country - by - country basis. 2. Total roy
Slide 37: Financials & Capital Management
Financials & Capital Management
Slide 38: Q2 2024 Financial Highlights
38 Q2 2024 Financial Highlights 1. Non - GAAP net profit (loss) from continuing operations consists of GAAP net income (loss) before taxes less share - based compen sation expense, non - cash interest expense, and non - cash impairment expense; see reconciliation on Slide 46 and the section titled "
Slide 39: 2024 Financial Guidance
39 2024 Financial Guidance 1. 2024 Estimates assume mid - point of Guidance; 2. Non - GAAP net profit (loss) from continuing operations is expected to consist of GAAP net income (loss) before taxes less share - based compensation expense, non - cash interest expense, and non - cash impairment expens
Slide 40: Summary: Theravance's Strategic Imperatives
40 Preserve Financial Strength Address the Significant Problem of nOH in MSA Devastating neurological disorder causing unremitting symptoms of autonomic failure in ~80% of patients 2,3 Ampreloxetine as best - in - class agent may be uniquely tailored to mitigate these symptoms and improve quality of
Slide 41: Senior Leadership
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 Senior Leadership
Slide 42: Appendix Slides
Appendix Slides
Slide 43: YUPELRI (revefenacin) Inhalation Solution
43 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
Slide 44: About YUPELRI (revefenacin) Inhalation Solution
44 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 45: Second Quarter 2024 Financials (Unaudited)
45 Second Quarter 2024 Financials (Unaudited) 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, non - cash interest expense and non - cash impairment expense;
Slide 46: Second Quarter 2024 Financials (Unaudited) (Cont'd)
46 Second Quarter 2024 Financials (Unaudited) (Cont’d) 46 See the section titled "Non - GAAP Financial Measures" on Slide 2 for more information. GAAP Net Loss $ (16,529) $ (15,645) $ (28,193) $ (37,733) Adjustments: Share-based compensation expense 5,376 6,264 10,604 13,285 Non-cash impairment of l
Slide 47: Granted Patent Protection into Late 2030s
47 Granted Patent Protection into Late 2030s COPD, chronic obstructive pulmonary disease; nOH , neurogenic orthostatic hypotension; PTE, patent term extensions. Estimated Patent Expiry Invention Compound 2028 Composition of Matter YUPELRI ® / revefenacin 2030 - 2031 Polymorph 2039 Method for the mai
Theravance Biopharma — Investor Presentation (September 2024) on 6ix