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Theravance Biopharma, Inc. (TBPH)·Q1 2025 Earnings Summary

Executive Summary

  • Q1 2025 revenue was $15.388M and GAAP diluted EPS was -$0.27; non-GAAP net loss was -$8.618M, with quarter-end cash of $130.855M and no debt .
  • YUPELRI net sales were $58.344M (+6% YoY), with customer demand +5% YoY and hospital doses +48% YoY; implied TBPH 35% share was $20.420M .
  • Reaffirmed full-year 2025 guidance (R&D $32–$38M; SG&A $50–$60M; SBC $18–$20M; non-GAAP loss and cash burn similar to 2024) .
  • Versus S&P Global consensus for Q1 2025, revenue was slightly below ($15.388M vs $15.575M*) while Primary EPS beat (-$0.173* vs -$0.207*)—a small positive surprise that management tied to disciplined investment and margin focus (S&P Global).
  • Key catalysts: continued TRELEGY momentum toward 2025–2026 milestones and ampreloxetine CYPRESS top-line ~6 months after final open-label enrollment (target late summer), plus ongoing Strategic Review Committee actions .

What Went Well and What Went Wrong

What Went Well

  • YUPELRI growth and hospital execution: “record high volume… approximately 316,000 units pulled through the hospital channel, up 48% year-over-year” .
  • TRELEGY strength and milestones: GSK reported Q1 TRELEGY net sales of $854M (+14% YoY), tracking toward the $50M 2025 milestone; consensus raised ~$100M since February call .
  • Ampreloxetine progress and NDA readiness: “anticipate enrolling the final patient into the open-label portion by late summer; top line data available ~6 months later… intend to request a priority review” .

What Went Wrong

  • Losses widened YoY: GAAP net loss -$13.579M versus -$11.664M in Q1 2024; non-GAAP net loss -$8.618M versus -$4.544M in Q1 2024, driven by higher R&D and SG&A as CYPRESS enrollment and NDA work ramped .
  • Operating expense pressures: OpEx ex-SBC rose (R&D and SG&A) for pre-launch medical affairs and regulatory/NDA activities; seasonality pressured Q1 collaboration revenue .
  • Slight top-line miss versus consensus: revenue of $15.388M vs $15.575M* (S&P Global), though Primary EPS beat helped offset the narrative (S&P Global).

Financial Results

MetricQ1 2024Q4 2024Q1 2025
Revenue ($USD Millions)$14.503 $18.754 $15.388
GAAP Net Income ($USD Millions)-$11.664 -$15.528 -$13.579
GAAP Diluted EPS ($USD)-$0.24 -$0.31 -$0.27
Net Income Margin %-80.4% -82.8% -88.2%
Non-GAAP MetricsQ1 2024Q4 2024Q1 2025
Non-GAAP Net Loss ($USD Millions)-$4.544 -$2.472 -$8.618
Q1 2025 vs Estimates (S&P Global)Consensus*Actual
Revenue ($USD Millions)$15.575*$15.388
Primary EPS ($USD)-$0.207*-$0.173*

Values marked with * retrieved from S&P Global.

Segment/Operational Breakdown and KPIs

MetricQ1 2024Q4 2024Q1 2025
YUPELRI Net Sales – Viatris (100%) ($USD Millions)$55.226 $66.680 $58.344
YUPELRI Implied TBPH 35% Share ($USD Millions)$19.329 $23.338 $20.420
TRELEGY Global Net Sales ($USD Millions)$749 $853 $854
YUPELRI Demand YoY (%)—+11% FY +5%
YUPELRI Hospital Doses (Units)—~285,000 ~316,000
YUPELRI Hospital Doses YoY (%)—+49% +48%
Cash & Equivalents ($USD Millions)—$88.350 $130.855

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
R&D (ex-SBC)FY 2025$32–$38M $32–$38M Maintained
SG&A (ex-SBC)FY 2025$50–$60M $50–$60M Maintained
Share-Based CompensationFY 2025$18–$20M $18–$20M Maintained
Non-GAAP Loss & Cash BurnFY 2025Similar to 2024 Similar to 2024 Maintained
Other Income Recognition (TRELEGY milestones)FY 2025–2026Recognize only after cumulative milestones >$194M; none expected until 2026 earliest Unchanged; none expected until 2026 earliest Maintained

Earnings Call Themes & Trends

TopicPrevious Mentions (Q3 2024)Previous Mentions (Q4 2024)Current Period (Q1 2025)Trend
Hospital execution & formulary/TIDoses +40% YoY; share gains; TI strategy highlighted Doses +49% YoY; ~285K units; record profitability ~316K units; +48% YoY; “record high volume” Improving
Pricing/channel mix & ASPSequential improvement vs Q2; mix strategy Favorable pricing vs H1 2024 Margin expansion focus; collaboration revenue seasonality noted Improving
Ampreloxetine CYPRESSOn track; mid-2025 open-label completion Positive FDA Type C alignment; expedited NDA plan Final open-label patient late summer; top-line ~6 months later; request priority review Progressing
Payer engagement (ampreloxetine)——Early payer education on endpoints, unmet need Initiated
Tariffs/macro exposure——No material impact expected; U.S.-based YUPELRI manufacturing; TRELEGY economics unaffected Stable
YUPELRI ChinaNDA filed June 2024; 14–20% royalties; $7.5M milestone on approval Timing reminder; potential royalties/milestone “Waiting for regulatory decision”; mid-2026 baseline Awaiting decision
IP/Litigation (Paragraph IV)——5 of 8 filers settled; 3 litigants outstanding Progressing
Competitive landscape (ensifentrine)Concomitant add-on use observed; nebulization awareness positive ——Neutral

Management Commentary

  • “YUPELRI delivered solid results… net sales increasing 6% to just over $58 million… hospital doses increased 48% year-on-year” – CEO Rick Winningham .
  • “We anticipate enrolling the final patient into the open-label portion by late summer with top line data available approximately 6 months later… intend to request a priority review” – SVP Development Áine Miller .
  • “This puts us on track to achieve the $50 million [TRELEGY] milestone this year… consensus estimates materially exceeding the sales thresholds” – CFO Aziz Sawaf .
  • “Our commercial partnership with Viatris delivered solid YUPELRI sales growth, aided by a strong performance in the hospital setting” – CEO Rick Winningham (press release) .

Q&A Highlights

  • Ampreloxetine manufacturing and IP: API manufacturing currently outside U.S. (Taiwan); IP resides in Ireland; management sees flexibility to adjust if needed .
  • Hospital transition-of-care: voucher program and local coordination to ensure discharge scripts convert to maintenance care; sharing best practices across territories .
  • Payer engagement: early discussions to educate on OHSA composite and quality-of-life endpoints; preparing for post-approval access dynamics .
  • YUPELRI Paragraph IV: five of eight filers settled; three ongoing litigants .
  • Tariffs: no material expected impact; TRELEGY milestones/royalties based on net sales (not COGS); YUPELRI benefits from U.S.-based manufacturing .

Estimates Context

  • Q1 2025: Revenue slightly missed ($15.388M actual vs $15.575M consensus*), while Primary EPS beat (-$0.173* actual vs -$0.207* consensus). GAAP diluted EPS reported was -$0.27 (different construct from S&P Primary EPS) .
  • Expect intra-year improvement as seasonality fades and hospital/community conversion efforts continue; consensus for TRELEGY supports 2025–2026 milestones per management .

Values marked with * retrieved from S&P Global.

Key Takeaways for Investors

  • YUPELRI remains a durable growth driver with strong hospital momentum and improving mix; watch adherence/persistency improvements and the pace of discharge-to-community conversion .
  • Ampreloxetine is the pivotal 2025–2026 catalyst: final open-label enrollment targeted late summer, with top-line ~6 months later and a planned priority review request if positive .
  • Operating expense profile should ease in H2 as CYPRESS completes, partly offset by NDA preparation; reaffirmed guidance reduces near-term estimate risk .
  • TRELEGY performance is a non-dilutive cash source (milestones), with consensus above thresholds for 2025 and 2026; note accounting recognition timing (no other income until cumulative milestones exceed $194M) .
  • Near-term trading implications: modest EPS beat vs consensus, slight revenue miss; stock may be more sensitive to CYPRESS enrollment/timing updates and Strategic Review Committee actions .
  • Medium-term thesis: combination of YUPELRI profitability, potential ampreloxetine launch in a high-unmet-need niche, and milestone/royalty economics can drive improving cash profile and value realization .

Appendix: Additional Relevant Q1 2025 Press Releases

  • Ampreloxetine analyses at International MSA Congress: subgroup results support mechanism and durable symptom relief; underscores unmet need in MSA nOH .
  • April announcement of upcoming MSA Congress presentations (mechanistic and burden analyses) .