Theravance Biopharma, Inc. · NASDAQ:TBPH
Theravance Biopharma — Q2 2024 Earnings Presentation
43 slides from Theravance Biopharma's earnings presentation, Aug 5, 2024
Slide 1: Second 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.
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 Ref orm Act of 1995 regarding, among other things, statements relating to goals, plans, objectives, expectations and future events. Theravance B
Slide 3: Agenda
3 Agenda Welcome / Opening Remarks Rick Winningham : Chairman and Chief Executive Officer YUPELRI ® / Commercial Overview Rhonda Farnum: Senior Vice President, Chief Business Officer Ampreloxetine / CYPRESS Update Dr. Áine Miller: Senior Vice President, Development Operating Results / Financial Upda
Slide 4: Strategic Objectives: Q2 2024 Progress
4 Strategic Objectives: Q2 2024 Progress 1. 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). 2. Source: Viatris Customer Demand (Q2’24) . 3 .
Slide 5: YUPELRI: First and only once-daily nebulized LAMA for 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) Rhonda Farnum Senior Vice President, Chief Business Officer
Slide 6: YUPELRI Net Sales Performance
6 YUPELRI ® 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 a rrangement (65% to Viatris ; 35% to Theravance Biopharma). 6 $16.5 $29.6 $36.8 $30.3 $37.0 $38.7 $36.9 $41.8 $39.4 $4
Slide 7: Strong Theravance Hospital Growth Accelerated
7 Strong Theravance Hospital Growth Accelerated 1. Source: IQVIA DDD, HDS, VA and Non - Reporting Hospital through Jun’24. Preliminary data subject to revision upon receipt of fi nal data. 7 19K 30K 54K 34K 47K 54K 56K 70K 78K 93K 98K 108K 113K 138K 162K 158K 162K 191K 213K 226K 0K 50K 100K 150K 200
Slide 8: YUPELRI Market Share Continues to Grow
8 YUPELRI ® Market Share Continues to Grow 1. Joint VTRS/TBPH Market Research (Jun’24). * Hospital LA - NEB Market Share - IQVIA DDD through Jun’24. †Community LA - NEB Market Share includes Retail + DME / Med B FFS through May’24. 8 9.5% 10.8% 11.3% 11.6% 13.3% 12.5% 15.0% 15.2% 16.1% 16.7% 16.6% 1
Slide 9: Substantial Opportunity for Further YUPELRI Growth
9 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 communit y p atients on YUPELRI in 2023. Sources: Citeline Pha
Slide 10: The YUPELRI China Opportunity
10 The YUPELRI ® China Opportunity 1. IQVIA Institute Global Use of Medicines 2024; 2. Wang C, Xu, J, Yang L, et al., The Lancet, 2018; 3. Yin P, Wang H, Vos T, et al., Chest, 2013, 4. Baipharm Monthly Report: New Drug Approvals, internal analysis (Jan ’23 – May ’24); 5. Source: Viatris (2021); 6. A
Slide 11: YUPELRI Value Proposition
11 YUPELRI ® Value Proposition 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 June 30, 2024, Theravance Biopharma is eligible t
Slide 12: Ampreloxetine: Investigational once-daily NET inhibitor for nOH in MSA
Ampreloxetine: Investigational once - daily norepinephrine transporter (NET) inhibitor For symptomatic neurogenic orthostatic hypotension ( nOH ) in multiple system atrophy (MSA) patients Dr. Áine Miller Senior Vice President, Development
Slide 13: CYPRESS Approach
13 CYPRESS Approach Focus on high - quality study prioritizing Centers of Excellence CYPRESS EXECUTION MSA, multiple system atrophy; RW, randomized withdrawal. Prioritize Academic Institutions and MSA Centers of Excellence (COE) Site Selection Leverage experienced sites to select appropriate patient
Slide 14: Study Progress and Key Milestones
14 Study Progress and Key Milestones Significant Acceleration in Sites Activations in Recent Quarters CYPRESS EXECUTION OL, open label 0 10 20 30 40 50 60 70 80 Q1 '23 Q2 '23 Q3 '23 Q4 '23 Q1 '24 Q2 '24 CYPRESS Site Activations First Patient Enrolled (US) Recruitment Opens >80% of Sites Activated To
Slide 15: CYPRESS Study: Randomized Withdrawal Study Design in Patients with MSA
15 CYPRESS Study: Randomized Withdrawal Study Design in Patients with MSA MSA, multiple system atrophy; OHSA, orthostatic hypotension symptom assessment; OL, open label; RW, randomized withdrawal. Entry Endpoint 8 - week double blind RW 12 - week open - label Baseline Randomization Ampreloxetine 10
Slide 16: Financial Update
Financial Update Aziz Sawaf Senior Vice President, Chief Financial Officer
Slide 17: Second Quarter 2024 Financials (Unaudited)
17 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 18: Second Quarter 2024 Financials (Unaudited) (Cont'd)
18 Second Quarter 2024 Financials (Unaudited) (Cont’d) 18 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 19: Q2 2024 Financial Highlights
19 Q2 2024 Financial Highlights Operating from a position of financial strength 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 rec
Slide 20: 2024 Financial Guidance
20 2024 Financial Guidance 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 21: TRELEGY Global Net Sales and Milestone Thresholds
21 21 0 500 1,000 1,500 2,000 2,500 3,000 3,500 4,000 4,500 2021 2022 2023 2024 E 2025 E 2026 E Consensus Forecast 3 Actuals 2 Net Sales ($M) Annual upper - tier threshold 1 Annual lower - tier threshold 1 TRELEGY Global Net Sales ($M) $50M $25M $50M $25M $100M $50M $1,674 $2,142 $2,739 $3,3 74 $3,7
Slide 22: Theravance's Strategic Focus
22 Theravance's Strategic FocusGrow YUPELRI, maximize ampreloxetine, optimize financial returns 1. As of June 30, 2024, Theravance Biopharma is eligible to receive from Viatris potential global development, regulatory and sales milestone payments (excluding China and adjacent territories) totaling u
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
24 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 25: About YUPELRI (revefenacin) Inhalation Solution
25 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 26: Appendix
Theravance ik Biopharma AR. Medicines That Make a Difference” Appendix
Slide 27: Appendix I: YUPELRI
Theravance ik Biopharma AR. Medicines That Make a Difference” Appendix I: YUPELRI®
Slide 28: Viatris Collaboration Agreement Revenue
28 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 29: Appendix II: Ampreloxetine
Theravance ik Biopharma AR. 7 Medicines That Make a Difference” Appendix II: Ampreloxetine
Slide 30: MSA Prevalence in the United States: ~50K Patients
30 MSA Prevalence in the United States: ~50K Patients Recent data confirm significant population with unmet needs 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”, P
Slide 31: Ampreloxetine ex-U.S. Opportunity
31 Ampreloxetine ex - U.S. Opportunity Significant unmet needs in leading therapeutics markets 1. Thelansis nOH Market Report 2023; TBPH Internal Analysis. nOH graphics reflect the mid - point of the provided ranges. 2. Prevalen ce estimate for Germany, France, UK, Italy and Spain. MSA, multiple sys
Slide 32: High Unmet Need in Symptomatic nOH in MSA
32 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, myalgic encephalomyelitis/chronic fatigue syndrome; MSA,
Slide 33: Ampreloxetine Offers Unique Hope
33 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
Slide 34: Effective Treatment Requires Intact Peripheral Nerves
34 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 35: Durable, Clinically-significant Symptom Improvements in MSA
35 Durable, Clinically - significant Symptom Improvements in MSA Demonstrated in Initial Phase 3 Program 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
Slide 36: Increased Norepinephrine, Prevented Blood Pressure Drop and Symptoms Worsening in MSA
36 Increased Norepinephrine, Prevented Blood Pressure Drop and Symptoms Worsening in MSA Patients 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 th
Slide 37: Study 0170 OHQ Questionnaire Composite Score and Individual Items in MSA
37 Study 0170 OHQ Questionnaire Composite Score and Individual Items in MSA Individual item score analyses are post - hoc, except for dizziness. CI, confidence interval; LS, least squares; MSA, multiple system atrophy; OHDAS, orthostatic hypotension daily activity scale ; OHQ, orthostatic hypotensio
Slide 38: Prevented Worsening of Standing SBP in MSA Patients with No Impact on Supine SBP
38 Prevented Worsening of Standing SBP in MSA Patients with No Impact on Supine SBP • Standing blood pressure improvement of 18.5 mmHg compared to placebo during randomized withdrawal phase • No difference in supine blood pressure relative to placebo Data from MSA patients at week 6 of the randomize
Slide 39: Appendix III: Corporate
Theravance ik Biopharma AR. 7 Medicines That Make a Difference” Appendix III: Corporate
Slide 40: Several Near and Mid-Term Catalysts and Value Creating Milestones
40 Several Near and Mid - Term Catalysts and Value Creating Milestones Product Catalyst Value Date Milestone for U.S. Net Sales > $250M in any calendar year $25M TBD Submission of China Application in COPD N/A June - 2024 Milestone for China Approval in COPD $7.5M TBD Ampreloxetine Last Patient In f
Slide 41: Granted Patent Protection Into Late 2030s
41 COPD, Chronic obstructive pulmonary disease; nOH, neurogenic orthostatic hypotension; PTE, patent term extensions. 41 Granted Patent Protection Into Late 2030s Compound Invention Estimated Patent Expiry YUPELRI ® / revefenacin Composition of Matter 2028 (once PTE awarded) Polymorph 2030 - 2031 Me
Slide 42: Progress Against Financial Targets
42 Progress Against Financial Targets Reduction in expense base combined with YUPELRI® net sales growth, and no debt 1. 2024 Estimates assume mid - point of Guidance; excludes $3.0M non - cash impairment charge incurred in Q2’24. 42 $0 $50 $100 $150 $200 $250 $300 $350 2021 2022 2023 2024E R&D SG&A
Slide 43: TRELEGY ELLIPTA Milestones and Royalties
43 Net Sales 2 : Q2’24 of $1.065B, +40% Y/Y ; 1H’24 of $1.814B, +37% Y/Y 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