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Theravance Biopharma, Inc. (TBPH)·Q3 2025 Earnings Summary

Executive Summary

  • Q3 2025 delivered record YUPELRI net sales of $71.4M (+15% YoY) and non-GAAP breakeven, with cash of $332.7M and no debt; GAAP EPS was $0.07 and non-GAAP net income was $2.3M .
  • Revenue of $20.0M grew 19% YoY, entirely from the Viatris collaboration; GAAP net income of $3.6M benefited from a $6.5M tax true-up tied to the Q2 TRELEGY royalty sale .
  • Guidance maintained for FY25 OpEx, but tone improved: management achieved non-GAAP breakeven in Q3 and expects similar breakeven in Q4 (ex one-time items), vs prior guidance for non-GAAP losses similar to 2024; milestone accounting reiterated for potential $25M YUPELRI (license revenue) and $50M TRELEGY (other income) in Q4 .
  • Near-term catalysts: triggering $25M YUPELRI milestone if Q4 net sales ≥ ~$54M, and $50M TRELEGY milestone if Q4 global sales ≥ ~$471M; medium-term transformational catalyst is CYPRESS Phase 3 ampreloxetine topline in Q1 2026 .

What Went Well and What Went Wrong

What Went Well

  • Record YUPELRI net sales and brand profitability: “Theravance delivered strong results…record YUPELRI net sales and the achievement of non-GAAP breakeven,” CEO Rick Winningham noted .
  • Hospital channel strength: doses up 29% YoY with hospital market share ~21%, reinforcing inpatient initiation and outpatient transition strategy .
  • TRELEGY momentum improves milestone visibility: Q3 global sales ~$1.0B and YTD ~$2.9B put FY25 $50M milestone within reach; only ~$471M needed in Q4 .

What Went Wrong

  • GAAP profit aided by one-time tax benefit: income tax benefit of $6.5M boosted GAAP net income; excluding it, Q3 would have been a $2.9M GAAP net loss .
  • SG&A up YoY: SG&A rose to $18.3M vs $16.9M prior year, reflecting pre-launch and commercial activities; share-based comp though declined YoY .
  • Revenue declined sequentially vs Q2 due to absence of Q2’s $7.5M licensing milestone (China approval), highlighting mix sensitivity to one-time items .

Financial Results

MetricQ3 2024Q2 2025Q3 2025
Revenue ($USD Millions)$16.868 $26.195 $19.990
GAAP Net Income ($USD Millions)$(12.698) $54.835 $3.615
GAAP Diluted EPS ($USD)$(0.26) $1.08 $0.07
Non-GAAP Net Income ($USD Millions)$(2.897) $(4.225) $2.260
Net Income Margin (%)(75.3)% 209.3% 18.1%

Notes: Net income margin computed from reported revenue and GAAP net income in cited filings.

Versus Estimates (Q3 2025)

MetricActualConsensusSurprise
Revenue ($USD Millions)$19.990 $19.900*+$0.090
EPS ($USD)$0.07 $(0.13)*+$0.20

Values retrieved from S&P Global.*

Segment/Revenue Breakdown

Revenue Component ($USD Millions)Q3 2024Q2 2025Q3 2025
Viatris Collaboration Revenue$16.868 $18.695 $19.990
Licensing Revenue$0.000 $7.500 $0.000
Total Revenue$16.868 $26.195 $19.990

KPIs

KPIQ3 2024Q2 2025Q3 2025
YUPELRI Net Sales (Viatris, $USD Millions)$62.189 $66.330 $71.363
TBPH Implied 35% Share ($USD Millions)$21.766 $23.216 $24.977
Customer Demand YoY Growth (%)—+4% +6%
Hospital Doses YoY Growth (%)—+31% +29%
Hospital Market Share (%)—20.4% ~21%
Cash, Cash Equivalents & Marketable Securities ($USD Millions)—$338.804 $332.700
Debt ($USD)—$0.0 $0.0

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
R&D (ex SBC)FY 2025$32M–$38M $32M–$38M Maintained
SG&A (ex SBC)FY 2025$50M–$60M $50M–$60M Maintained
Share-Based CompensationFY 2025$18M–$20M $18M–$20M Maintained
Non-GAAP Net Income from OperationsQ4 2025Similar non-GAAP loss to 2024 Breakeven expected (ex one-time) Raised
Milestone AccountingQ4 2025TRELEGY/ YUPELRI milestones recognized when earned TRELEGY $50M other income; YUPELRI $25M license revenue if thresholds met Clarified (maintained policy)

Earnings Call Themes & Trends

TopicPrevious Mentions (Q1 2025)Previous Mentions (Q2 2025)Current Period (Q3 2025)Trend
YUPELRI product performanceNet sales $58.3M; hospital doses +48% YoY; addressable market remains sizable Net sales $66.3M; demand +4% YoY; one-time price benefit; hospital doses +31% YoY Record net sales $71.4M; demand +6% YoY; hospital doses +29% YoY; market share ~21% Improving
R&D execution (CYPRESS)Open-label nearing completion; topline ~6 months after last patient Enrollment complete by late summer; NDA prep underway Open-label complete; topline on track Q1 2026; expedited NDA and priority review planned On track
Regulatory/legalOrphan Drug designation reiterated; NDA planning NDA readiness and alignment with FDA Preparing for expedited NDA; KOL event 12/8 Building
TRELEGY milestones/macroQ1 sales $854M; 2025/26 milestones laid out Q2 sales $1.1B; YTD $2.0B; $50M milestone on pace Q3 sales ~$1.0B; YTD ~$2.9B; ~$471M needed in Q4 to hit $50M Strengthening
Capital allocation/Strategic ReviewCommittee active; return excess capital emphasized First outcome: $225M TRELEGY sale; capital return focus Return excess cash reiterated; Q&A focused on capital vs launch funding Shareholder-friendly
Disease education/market developmentClinical presentations (AAN, MSA congress) Clinical/scientific updates continue Disease education campaign “Power in the Periphery” launched; AAS presentations Expanding engagement

Management Commentary

  • CEO: “Theravance delivered strong results in the third quarter, highlighted by record YUPELRI net sales and the achievement of non-GAAP breakeven…” .
  • CBO: “Q3 net sales increased 15% year-over-year to $71.4 million…hospital volume increasing 29% versus Q3 of 2024…market share ~21%” .
  • CFO: “We achieved non-GAAP profit break-even in the quarter…ended with $333 million of cash and no debt…expect $75 million of milestones in Q4” .
  • Development: “Open-label portion is complete…top-line results in the first quarter of 2026…intend to request priority review if the data are supportive” .

Q&A Highlights

  • Capital returns vs launch readiness: Management emphasized financial strength and will revisit capital return decisions post-CYPRESS topline; ampreloxetine launch expected to be efficient (rare disease) .
  • Pipeline focus: Near-term 110% focus on growing YUPELRI and executing CYPRESS; broader options evaluated post-success to maximize shareholder value .
  • Clinical endpoints/MCID: A one-point OHSA composite change is clinically meaningful; Cypress is designed to replicate prior MSA subgroup benefits and includes FDA-aligned anchoring analysis .
  • Hospital data utilization: CHEST analyses on exacerbations and cost reduction will be pursued for medical education and promotional reinforcement .

Estimates Context

  • Q3 2025 EPS beat: Actual $0.07 vs consensus $(0.13); revenue in line/slight beat: $20.0M vs $19.9M .
  • Expect estimates to reflect improved non-GAAP profitability trajectory (breakeven in Q3 and expected similar breakeven in Q4), stronger YUPELRI brand profitability, and high-probability Q4 milestones ($75M) .

Values retrieved from S&P Global.*

Key Takeaways for Investors

  • Positive inflection in profitability: Non-GAAP breakeven achieved; management expects similar breakeven in Q4 (ex one-time items), improving the near-term P&L profile .
  • Durable YUPELRI growth: Record net sales, expanding margins, and strong hospital channel metrics underpin cash generation; $25M milestone likely if Q4 net sales ≥ ~$54M .
  • Milestone cash catalysts: TRELEGY momentum suggests $50M FY25 and $100M FY26 milestones are within reach; cash receipt expected Q1 following achievement .
  • Ampreloxetine catalyst: CYPRESS topline in Q1 2026 represents a transformational outcome; expedited NDA and priority review planning could compress timelines if data are favorable .
  • Capital deployment flexibility: Robust cash ($332.7M) and no debt support strategic optionality, including potential additional capital returns post-data .
  • Trading implications: Near-term stock drivers include Q4 milestone attainment and continued YUPELRI execution; medium-term is dominated by CYPRESS readout and regulatory trajectory .
  • Watch items: Mix effects from one-time items (licensing/milestones) on reported revenue; SG&A trend as pre-launch costs progress; hospital share sustainability and payer dynamics .

Supporting Detail and Disclosures

  • Third Quarter Financials and Viatris Collaboration: revenue $19.990M, GAAP net income $3.615M, non-GAAP net income $2.260M, cash $332.7M; YUPELRI net sales $71.363M; implied 35% share $24.977M .
  • Guidance and Milestone Accounting: FY25 OpEx ranges maintained; non-GAAP breakeven achieved with similar expected in Q4; TRELEGY and YUPELRI milestones accounting clarified .
  • Prior Quarters for Trend: Q2 2025 revenue $26.195M (incl. $7.5M licensing), GAAP EPS $1.08; Q1 2025 revenue $15.388M, GAAP net loss $(13.579) .
  • TRELEGY Sales: Q3 global net sales ~$1.0B; YTD ~$2.9B; thresholds to trigger $50M FY25 and $100M FY26 milestones outlined .
  • Ampreloxetine Program: CYPRESS open-label complete; topline Q1 2026; disease education campaign and AAS presentations support scientific engagement .