Theravance Biopharma, Inc. · NASDAQ:TBPH
Theravance Biopharma — Investor Presentation (September 2023)
38 slides from Theravance Biopharma's investor presentation, Sep 12, 2023
Slide 1: Investor Presentation September 2023
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. I
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: Strategic Objectives to Drive Value Creation
Strategic Objectives to Drive Value Creation 3 1. Non - GAAP profit is expected to consist of GAAP income before taxes less share - based compensation expense and non - cash interes t expense. See the section titled "Non - GAAP Financial Measures” on Slide 2 for more information. MSA, multiple syste
Slide 4: 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 Co - promotion agreement with VIATRIS ® (35% / 65% Profit Share)
Slide 5: YUPELRI: Growing Net Sales and Hospital Volume
107,790 113,220 137,760 159,720 156,180 K 20 K 40 K 60 K 80 K 100 K 120 K 140 K 160 K 180 K Q2'22 Q3'22 Q4'22 Q1'23 Q2'23 $49.1 $53.4 $55.7 $47.0 $55.0 0 10 20 30 40 50 60 Q2'22 Q3'22 Q4'22 Q1'23 Q2'23 YUPELRI ® | Growing Net Sales and Hospital Volume 5 YUPELRI Hospital Doses Hospital doses sold inc
Slide 6: YUPELRI Hospital and Community Share Trends
YUPELRI ® Hospital and Community Share Trends 6 1. Joint VTRS/TBPH Market Research. * Hospital LA - NEB Market Share - IQVIA DDD through 6/30/2023. †Community LA - NEB Market Share includes Retail + DME / Med B FFS through May’23. 6.6% 7.6% 7.6% 8.6% 9.5% 10.7% 11.3% 11.6% 13.3% 12.5% 14.9% 15.2% 0%
Slide 7: YUPELRI Retail Trends
7 Source: Symphony Health METYS Prescription Dashboard through 6/30/2023. 9.7% 6.8% - 2.0% 10.2% 4.9% 4.1% 6.9% 7.8% K 5 K 10 K 15 K 20 K 25 K 30 K 2021-Q2 2021-Q3 2021-Q4 2022-Q1 2022-Q2 2022-Q3 2022-Q4 2023-Q1 2023-Q2 YUPELRI Retail TRx YUPELRI Retail TRx YUPELRI Retail TRx - 6.1% 9.5% 0.1% 11
Slide 8: Substantial Opportunity for Further YUPELRI Growth
8 Substantial Opportunity for Further YUPELRI ® Growth Long - Acting Nebulized Maintenance Patients Patients Using Short - Acting Nebulized Therapy ~200K Current Long - Acting Neb Patients ~200K Patients Inappropriately Using Short - Acting Nebulized Treatments for Maintenance Therapy Current COPD P
Slide 9: Development
Development YUPELRI PIFR - 2 Last patient enrolled; top - line disclosure anticipated Jan ’24 CYPRESS ( ampreloxetine ) Last patient enrolled anticipated H2 ‘24
Slide 10: YUPELRI Phase 4 Randomized 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 Suboptimal
Slide 11: PIFR-Experience Informed PIFR-Design
PIFR - 1 Experience Informed PIFR - 2 Design Chronic Obstr Pulm Dis . 2019; 6(4): 321 – 331. Note: The ns shown are the numbers in the analysis set or subset. Evaluable ns are 90 (Tio) and 89 (Rev) for the ITT analysis an d 70 (Tio) and 70 (Rev) for the subset analysis. FEV1, forced expiratory volum
Slide 12: Ampreloxetine
Ampreloxetine Investigational once - daily norepinephrine reuptake inhibitor For symptomatic neurogenic orthostatic hypotension (nOH) in multiple system atrophy (MSA) patients
Slide 13: The Ampreloxetine Opportunity: Symptomatic nOH in MSA
13 The Ampreloxetine Opportunity: Symptomatic nOH in MSA 1. Wan, L., Zhu, S., Chen, Z. et al., Transl Neurodegener 12, 38 (2023). 2. UCSD Neurological Institute (25K - 75K, with ~10K new cases per year); NIH National Institute of Neurological Disorders and Str oke (15K - 50K). 3. Delveinsight MSA Ma
Slide 14: Ampreloxetine: Designed to Reduce Symptoms in MSA
Untreated nOH NE Release Systolic Blood Pressure Ampreloxetine: Designed to Reduce Symptoms in MSA 14 Palma JA, Kaufmann H. Mov Disord Clin Pract 2017;4:298 - 308. 1. Data from MSA patients reported after 4 weeks of ampreloxetine administration in study 0169. 2. Data from MSA patients at week 6 of t
Slide 15: Study 0170: Prevented Blood Pressure Drop and Symptoms Worsening in MSA
Study 0170: Ampreloxetine Prevented Blood Pressure Drop and Symptoms Worsening in MSA 1 15 1. Data from MSA patients at week 6 of the randomized withdrawal period of study 0170 (n=33 for BP response, n=38 for OHSA Co mpo site). 2. The OHSA Composite is a neurological assessment tool measuring six cl
Slide 16: Studies 0169/0170: Durable Symptom Improvements in MSA
16 CI, confidence interval; MSA, multiple system atrophy; OHSA, Orthostatic Hypotension Symptom Assessment; OL, open - label; RW, ran domized withdrawal. Studies 0169/0170: Ampreloxetine Delivered Durable Symptom Improvements in MSA 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 01
Slide 17: Effective Treatment Requires Intact Peripheral Nerves
17 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 18: High Probability of Technical Success
High Probability of Technical Success CYPRESS: Phase 3 randomized withdrawal (RWD) study in patients with MSA 18 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 19: The Unique Benefits of Ampreloxetine Treatment
Study 0170 OHQ Questionnaire Scores LS Mean (95% CI) OHSA Symptoms composite score - 1.6 ( - 2.7, - 0.5) Dizziness - 1.5 ( - 3.2, 0.2) Vision - 1.7 ( - 3.2, - 0.3) Weakness - 0.7 ( - 2.3, 0.9) Fatigue - 1.5 ( - 3.1, 0.1) Trouble concentrating - 1.8 ( - 3.3, - 0.4) Head/neck discomfort - 2.2 ( - 3.7,
Slide 20: Ampreloxetine's Significant Potential
Ampreloxetine’s Significant Potential 20 Reflects Theravance Biopharma's expectations for ampreloxetine based on clinical trial data to date. Ampreloxetine is in deve lop ment and not approved for any indication. Data on file. 1. UCSD Neurological Institute (25K - 75K, with ~10K new cases per year);
Slide 21: Financial Update
Financial Update Theravance “i Biopharma Ar
Slide 22: Second Quarter 2023 Financials
Second Quarter 2023 Financials 22 1. Amounts include share - based compensation. 2. Non - GAAP net loss from continuing operations consists of GAAP net loss before taxes excluding share - based compensation expens e and non - cash interest expense; see reconciliation on Slide 20 and the section titl
Slide 23: Second Quarter 2023 Financials (Cont'd)
Second Quarter 2023 Financials (Cont’d) 23 See the section titled "Non - GAAP Financial Measures" on Slide 2 for more information. GAAP Net Loss from Continuing Operations $ (15,645) $ (22,793) $ (37,733) $ (63,052) Adjustments: Share-based compensation expense 6,264 9,709 13,285 24,254 Non-cash int
Slide 24: Q2 2023 Financial Highlights
Q2 2023 Financial Highlights Significant Capital Returns from a Position of Strength 24 1. Non - GAAP loss from continuing operations consists of GAAP loss before taxes excluding share - based compensation expense and no n - cash interest expense; see reconciliation on Slide 20 and the section title
Slide 25: 2023 Financial Guidance
2023 Financial Guidance Expect to Generate Non - GAAP 1 Profit in 2H 2023 25 1. Non - GAAP profit is expected to consist of GAAP income before taxes less share - based compensation expense and non - cash interes t expense; see the section titled "Non - GAAP Financial Measures" on Slide 2 for more in
Slide 26: $325 Million Capital Return Program
x ~$95M: Purchased GSK's equity stake in Theravance (Sep’22) and completed Dutch auction tender offer (Nov’22) x >$80M completed in Q2 2023 $325 Million Capital Return Program On Track to Complete Program by Year - End 26 Complete ($95M) Open Market Share Buybacks Complete ($169M) At 6/30/23: ~$264M
Slide 27: TRELEGY ELLIPTA Milestones and Royalties
Q2’23 Net Sales of $760 M |YTD Net Sales of $1.33B 4 Outer - Year Royalties 3 return in 2029: TRELEGY ELLIPTA Milestones and Royalties GSK’s TRELEGY ELLIPTA (FF/UMEC/VI): First and only once - daily single inhaler triple therapy 27 1. If both milestones are achieved in a given year, Theravance Bioph
Slide 28: Theravance Biopharma: Positioned for Value Creation
Theravance Biopharma: Positioned for Value Creation MSA, multiple system atrophy; nOH, neurogenic orthostatic hypotension. Ampreloxetine for nOH new era in treating MSA symptoms Substantial opportunity for further growth Potential to offer a unique, first in class treatment benefit Retained future v
Slide 29: Senior Leadership
Rick E Winningham Chairman and Chief Executive Officer Aziz Sawaf, CFA Senior Vice President, Chief Financial Officer Rhonda F. Farnum Senior Vice President, Chief Business Officer Richard A. Graham Senior Vice President, Research and Development Senior Leadership
Slide 30: 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 31: 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 32: Appendix
Theravance kX Biopharma AR. Medicines That Make a Difference” Appendix
Slide 33: Patent Protection Into Late 2030s
Patent Protection Into Late 2030s 33 COPD, Chronic obstructive pulmonary disease ; nOH, neurogenic orthostatic hypotension; PTE, patent term extensions. Compound Invention Granted / Pending Application Estimated Patent Expiry YUPELRI ® / revefenacin Composition of Matter Granted US 2028 (once PTE aw
Slide 34: Viatris Collaboration Agreement Revenue
34 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
Slide 35: 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 35 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
Slide 36: Offering Hope to MSA Patients with Symptomatic nOH
Offering Hope to MSA Patients with Symptomatic nOH 36 MSA, multiple system atrophy; nOH, neurogenic orthostatic hypotension. 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 an
Slide 37: Shift Toward Broad Symptomatic Improvement for MSA Patients
Shift Toward Broad Symptomatic Improvement for MSA Patients 1. Data from MSA patients at week 6 of the randomized withdrawal period of study 0170. 2. Biaggioni I, et al. Abstract 34 / Virtual Poster 106; Kaufmann H, et al. Abstract 33 / Virtual Poster 117; Freeman R, et al. Abstract 30 / Virtual Pos
Slide 38: Shift Toward Broad Symptomatic Improvement for MSA Patients
Shift Toward Broad Symptomatic Improvement for MSA Patients 1. Data from MSA patients at week 6 of the randomized withdrawal period of study 0170. 2. Biaggioni I, et al. Abstract 34 / Virtual Poster 106; Kaufmann H, et al. Abstract 33 / Virtual Poster 117; Freeman R, et al. Abstract 30 / Virtual Pos
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