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Theravance Biopharma, Inc. (TBPH)·Q4 2024 Earnings Summary

Executive Summary

  • Record YUPELRI US net sales of $66.7M in Q4 (+10% YoY) and $238.6M for FY 2024 (+8% YoY); hospital doses up 49% YoY and brand-level profitability at launch-to-date highs. Bold takeaway: YUPELRI demand and hospital execution drove a record quarter .
  • Q4 total revenue was $18.8M (all Viatris collaboration revenue); GAAP net loss was $(15.5)M and Non-GAAP net loss $(2.5)M; YE cash was $88.4M (excludes $50M TRELEGY milestone received in Feb 2025) .
  • GSK-reported TRELEGY net sales were $3.46B in FY 2024 (+26% YoY), triggering a $50M milestone to Theravance; management sees potential for up to $150M of additional milestones across 2025–2026. Bold takeaway: TRELEGY milestones provide near-term cash and medium-term optionality .
  • 2025 guidance: R&D (ex-SBC) $32–38M, SG&A (ex-SBC) $50–60M, SBC $18–20M; expect minimal Non-GAAP losses and cash burn similar to 2024; updated accounting for TRELEGY milestones delays “Other Income” recognition until cumulative milestones exceed $194M .
  • Strategic Review Committee continues to evaluate alternatives to unlock shareholder value; near-term catalysts include YUPELRI growth/milestones, China NDA approval, TRELEGY milestones, and the Phase 3 CYPRESS enrollment and NDA readiness for ampreloxetine .

What Went Well and What Went Wrong

What Went Well

  • Record YUPELRI performance: net sales reached $66.7M (+10% YoY), demand up 9% QoQ, hospital doses up 49% YoY; “Our hospital-based commercial organization executed particularly well through the end of the year” (CEO) .
  • TRELEGY strength and milestones: FY 2024 sales of $3.46B (+26% YoY) triggered a $50M payment; management expects high probability of additional milestones in 2025–2026 (CFO) .
  • Ampreloxetine progress: FDA Type C interaction reaffirmed the regulatory path; on track to enroll last patient in CYPRESS open-label mid-2025 with top-line ~6 months later; strong physician receptivity to the target profile .

What Went Wrong

  • Profitability still negative: GAAP net loss $(15.5)M; Non-GAAP net loss $(2.5)M in Q4; sequential increase in operating expenses excluding SBC to $22.1M tied to prelaunch and enrollment spend .
  • Near-term seasonality: Management flagged typical Q1 softness in collaboration revenue given YUPELRI seasonality (CBO) .
  • Estimates comparison unavailable: S&P Global consensus estimates could not be retrieved at the time of analysis, limiting beat/miss assessment (see Estimates Context) [GetEstimates error].

Financial Results

MetricQ2 2024Q3 2024Q4 2024
Total Revenue ($USD Millions)$14.256 $16.868 $18.754
GAAP Net Loss ($USD Millions)$(16.529) $(12.698) $(15.528)
Basic & Diluted EPS ($USD)$(0.34) $(0.26) $(0.31)
Non-GAAP Net Income (Loss) ($USD Millions)$(6.250) $(2.897) $(2.472)
Net Income Margin %-115.7% -75.3% -82.8%
Cash & Equivalents ($USD Millions)$96.078 $91.361 $88.350

Segment/KPI Detail

MetricQ2 2024Q3 2024Q4 2024
YUPELRI Net Sales (100% recorded by Viatris, $USD Millions)$54.530 $62.189 $66.680
TBPH Implied 35% Share of YUPELRI Net Sales ($USD Millions)$19.085 $21.766 $23.338
Viatris Collaboration Revenue ($USD Millions)$14.256 $16.868 $18.754
Hospital Doses (Units)226K 227K 285K
Operating Expenses excl. SBC ($USD Millions)$21.634 $21.180 $22.128

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
R&D (ex-SBC)FY 2025N/A$32–38M New
SG&A (ex-SBC)FY 2025N/A$50–60M New
Share-Based CompensationFY 2025N/A$18–20M New
Non-GAAP Loss & Cash BurnFY 2025N/AMinimal; similar to 2024 levels New
TRELEGY Milestone Accounting (Other Income)FY 2025–2026Prior recognition thresholds lowerRecognize Other Income only after cumulative milestones >$194M; none expected in 2024–2025; ~$6M in 2026 if $150M achieved Updated accounting
YUPELRI US Sales MilestoneNext eligible yearN/A$25M milestone upon first calendar year net sales ≥$250M Potential milestone (not formal guidance)

Earnings Call Themes & Trends

TopicPrevious Mentions (Q2 2024)Previous Mentions (Q3 2024)Current Period (Q4 2024)Trend
YUPELRI pricing/channel mixASP headwinds; corrective actions underway; expect improvement in 2025 Sequential ASP/channel mix improvement vs Q2; optimism into 2025 Favorable pricing and improved channel mix supported record net sales; remind Q1 seasonality Improving into 2025; near-term Q1 seasonal dip
Hospital executionDoses up 43% YoY; formulary wins driving discharge scripts Doses up 40% YoY; therapeutic interchange expanding share Doses up 49% YoY; execution across large systems and interchange protocols (CBO detail) Strengthening; key growth flywheel
China NDA (YUPELRI)NDA filed June 2024; strong partner; 15-month median review Continued emphasis on China economics and milestones Awaiting regulatory decision; baseline timing mid-2026; $7.5M approval milestone, 14–20% royalties On track; approval timing watch
TRELEGY milestonesConfidence in 2024 milestones; consensus above thresholds $50M milestone likely with Q4 sales >$610M (below consensus) $50M achieved; potential $150M in 2025–2026; royalties return from 2029 Delivering; multi-year cash/royalty tail
Ampreloxetine (CYPRESS)Timeline updated: last patient mid-2025; top-line ~6 months later; FDA-aligned design Enrollment momentum; safety/tolerability data updates FDA Type C interaction reaffirmed NDA path; launch readiness research shows high unmet need; strong intent to prescribe Progressing to pivotal inflection
Strategic ReviewExploring ways to unlock value (tax assets, YUPELRI, ampreloxetine, TRELEGY) Formal Strategic Review Committee formed; separated Chair/CEO roles Committee continues evaluation; capital discipline reiterated Ongoing; potential corporate actions

Management Commentary

  • CEO: “Theravance Biopharma ended 2024 on a high note… record fourth quarter YUPELRI net sales and profitability, while achieving $50 million in TRELEGY related sales milestones… positioning us to continue driving YUPELRI growth in 2025 and beyond.”
  • CBO: “The growth in Q4 was primarily driven by a 9% increase in demand… an improved channel mix, meaning stronger demand in the higher-margin channels.”
  • CFO: “Given the brand's continued growth trajectory and consensus being well above the required thresholds, we believe there is a high probability of achieving the higher end of milestones in both 2025 and 2026, totaling an additional $150 million.”
  • Development SVP: “We reaffirmed alignment on key requirements for a full approval should the CYPRESS study be positive… poised for an expedited regulatory filing… intend to request a priority review.”

Q&A Highlights

  • Hospital channel drivers: Execution across large systems, therapeutic interchange embedded in EMR protocols, 14-person hospital team focus; interchange accounts at ~36% share vs ~19% overall (CBO) .
  • Seasonality: Management cautioned Q1 tends to be softer; hospital census (RSV/flu) a tailwind but overall Q1 seasonal dip expected (CBO) .
  • China timing: Baseline assumption ~2 years from June 2024 submission → mid-2026; $7.5M approval milestone and 14–20% royalties (CFO) .
  • FDA feedback and NDA prep: Type C meeting to confirm filing content; investing in completing major NDA modules pre-readout to expedite filing (CEO) .
  • SG&A build for ampreloxetine: No incremental 2025 FTEs pre-data; measured investments (~$55M midpoint SG&A ex-SBC) for market research/access/medical affairs (CFO) .

Estimates Context

  • S&P Global consensus (EPS/revenue) for TBPH could not be retrieved at the time of analysis due to an API limit; therefore, beat/miss vs Street is unavailable. We anchored assessment on reported actuals, guidance, and qualitative commentary. Values from S&P Global were unavailable at time of analysis [GetEstimates error].

Key Takeaways for Investors

  • YUPELRI’s Q4 record and hospital execution validate the growth flywheel; watch Q1 seasonal softness, then potential ASP/channel mix improvements into 2025 to support net sales growth trajectory .
  • TRELEGY cash inflows are real: $50M received in Feb 2025 and potential up to $150M across 2025–2026; royalty stream returns beginning 2029 (ex-US) and 2031 (US) .
  • 2025 opex discipline: R&D (ex-SBC) $32–38M; SG&A (ex-SBC) $50–60M; SBC $18–20M; management targets minimal Non-GAAP losses and cash burn similar to 2024, preserving cash for pivotal readout and launch prep .
  • Ampreloxetine offers a pivotal 2H25 inflection: FDA alignment, strong physician interest, and differentiated profile; success could transform medium-term outlook; risk remains around clinical outcomes and regulatory review timing .
  • Strategic Review Committee is a potential corporate catalyst (asset monetization/partnering/structural moves); near-term visibility remains limited, but governance steps and Lazard engagement signal intent to unlock value .
  • China adds incremental optionality: YUPELRI NDA filed; potential $7.5M approval milestone and attractive royalties; timing baseline mid-2026 .
  • Traders: near-term narrative hinges on Q1 seasonality vs sustained hospital momentum; medium-term positioning should factor TRELEGY milestone cadence and CYPRESS timeline as stock-moving events .