Theravance Biopharma, Inc. · NASDAQ:TBPH
Theravance Biopharma — Q1 2025 Earnings Presentation
23 slides from Theravance Biopharma's earnings presentation, May 8, 2025
Slide 1: First Quarter 2025 Financial Results and Business Update
Theravance Biopharma First Quarter 2025 Financial Results and Business Update May 8, 2025 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).
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 Reform Act of 1995 regarding, among other things, statements relating to goals, plans, objectives, expectations and future events. Theravance Biopha
Slide 3: Agenda
Agenda Opening & Closing Remarks Rick Winningham: Chief Executive Officer Commercial Updates Rhonda Farnum: Senior Vice President, Chief Business Officer Development & Regulatory Updates Dr. Áine Miller: Senior Vice President, Development TRELEGY & Financial Updates Aziz Sawaf: Senior Vice President
Slide 4: Continued Momentum to Start 2025 Across All Value Drivers
Continued Momentum to Start 2025 Across All Value Drivers Ampreloxetine TRELEGY / Corporate • Q1 net sales of $58.3M increased 6% Y/Y1 • CYPRESS open label enrollment nearing • 2024 TRELEGY net sales reached $854M completion (+14% Y/Y), on pace to trigger 2025 • Customer demand increased 5% Y/Y2 mil
Slide 5: The Only Once-Daily, Nebulized LAMA Maintenance Medicine for COPD
The Only Once-Daily, Nebulized LAMA Maintenance Medicine for COPD Co-promotion agreement with VIATRISTM (35% / 65% Profit Share) Rhonda Farnum Senior Vice President, Chief Business Officer COPD, chronic obstructive pulmonary disease; LAMA, long-acting muscarinic antagonist
Slide 6: Continued Year-over-Year YUPELRI Net Sales Growth in the US
Continued Year-over-Year YUPELRI® Net Sales Growth in the US Annual YUPELRI Net Sales Quarterly YUPELRI Net Sales (2023 to Present) 250 $238.6 80 $221.0 $66.7 Total YUPELRI Net Sales ($M) $201.9 70 200 $60.6 $62.2 60 $58.3 $58.3 $55.0 $55.2 $54.5 $161.9 $142.8 50 $47.0 150 40 100 30 $55.1 20 50 10 0
Slide 7: US Hospital Growth Continues Over Years into Launch
US Hospital Growth Continues Over 6 Years into Launch 350K 316 K 300K 286 K 250K YUPELRI Hospital Doses 228 K 227 K 214 K 200K 192 K 163 K 158 K 162 K 150K 138 K 108 K 113 K 93 K 98 K 100K 78 K 70 K 56 K 50K 0K Q1'21 Q2'21 Q3'21 Q4'21 Q1'22 Q2'22 Q3'22 Q4'22 Q1'23 Q2'23 Q3'23 Q4'23 Q1'24 Q2'24 Q3'24
Slide 8: Significant YUPELRI Future Potential
Significant YUPELRI® Future Potential Continued Opportunity for Demand Growth • Market research supports continued growth with sizable remaining addressable patient population1 • Increasing adoption of concomitant use with LAMA/LABA and switches from handheld-only regimens • Success in further diver
Slide 9: GSK's TRELEGY
GSK’s TRELEGY The First And Only Once-Daily Triple Therapy In a Single Inhaler For Adult Patients With COPD Or Asthma Milestone and royalty agreement with Royalty Pharma Aziz Sawaf Senior Vice President, Chief Financial Officer COPD, chronic obstructive pulmonary disease
Slide 10: Up to $150M in TRELEGY Sales Milestones in 2025 and 2026
Up to $150M in TRELEGY Sales Milestones in 2025 and 2026 Q1’25 Net Sales of $854M, up 14% YoY; on pace to trigger 2025 and 2026 milestones 2025 and 2026 Sales Milestones1 Strong TRELEGY Global Net Sales Growth ($M) $4,500 $4,117 $3,926 Global Net Sales Royalty Milestone to $4,000 Year $3,456 Equival
Slide 11: TRELEGY Royalties Returning in 2029 Represent a Significant Source of Value
TRELEGY Royalties Returning in 2029 Represent a Significant Source of Value Beginning in 2029, royalties from 5.5% - 8.5% on TRELEGY net sales return to Theravance Biopharma1 Overview of Royalty Terms Total Global TRELEGY Net Sales ($M) (Consensus Estimates 2) Royalties extend until longest-lived pa
Slide 12: Ampreloxetine
AMPRELOXETINE The first once-daily, selective norepinephrine reuptake inhibitor in development to treat symptomatic nOH in MSA Dr. Áine Miller Senior Vice President, Development MSA, multiple system atrophy; nOH, neurogenic orthostatic hypotension
Slide 13: CYPRESS Update
CYPRESS Update Quality-first approach to study execution • Disciplined, data-driven approach in collaboration with high quality centers • Open label enrollment approaching completion with last patient anticipated by late summer • Top line data anticipated ~6 months after last patient enrolled into t
Slide 14: Scientific and Regulatory Updates
Scientific and Regulatory Updates American Academy of Neurology (April 2025) • Back-to-back oral presentations with new analyses from the previous Phase 3 program validating ampreloxetine’s target engagement, pharmacodynamic effects on blood pressure; analyses suggest no worsening of supine hyperten
Slide 15: Financial Update
Financial Update Aziz Sawaf Senior Vice President, Chief Financial Officer
Slide 16: First Quarter 2025 Financials (Unaudited)
First Quarter 2025 Financials (Unaudited) Three Months Ended March 31, ($, in thousands) 2025 2024 (Unaudited) Revenue: Viatris collaboration agreement $ 15,388 $ 14,503 Total revenue 15,388 14,503 Costs and expenses: Research and development (1) 11,452 8,968 Selling, general and administrative (1)
Slide 17: First Quarter 2025 Financials (Unaudited) (Cont'd)
First Quarter 2025 Financials (Unaudited) (Cont’d) Reconciliation of GAAP to Non-GAAP Net Loss (In thousands, except per share data) Three Months Ended March 31, 2025 2024 (Unaudited) GAAP Net Loss $ (13,579) $ (11,664) Adjustments: Share-based compensation expense 4,877 5,229 Non-cash interest expe
Slide 18: First Quarter 2025 Financial Highlights
First Quarter 2025 Financial Highlights Metric Q1 ‘25 (M) Q1 ‘24 (M) Note VIATRIS Collaboration Revenue $15.4 $14.5 Increase driven by ampreloxetine: • R&D: Higher CYPRESS enrollment and SG&A and R&D Expense, ex-SBC $24.9 $20.5 incremental NDA and regulatory activities • SG&A: Commercial and medical
Slide 19: Reiterating All Financial Guidance Metrics
Reiterating All Financial Guidance Metrics 2025 OPEX Guidance: Operating Expenses ($M) • R&D (excluding share-based comp): $32M - $38M $140 • SG&A (excluding share-based comp): $50M - $60M $120 111.3 • Share-Based Compensation: $18M - $20M 109.0 2025 Non-GAAP Loss and Cash Burn Guidance1: $100 32.5
Slide 20: Strong Cash Generation; Significant Upside Potential with Ampreloxetine
Strong Cash Generation; Significant Upside Potential with Ampreloxetine Compelling Financial Profile $131 million in cash at quarter end, with $50M milestone received; no debt, and limited cash use anticipated Up to $150M in additional TRELEGY milestones possible through 2026; royalties returning fr
Slide 21: Q&A Session
Q&A Session Rhonda Farnum Rick Winningham Senior Vice President, Chief Executive Officer Chief Business Officer Aziz Sawaf, CFA Áine Miller Senior Vice President, Senior Vice President, Chief Financial Officer Development
Slide 22: 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 compo
Slide 23: 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 nebulizer