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BridgeBio Pharma, Inc. (BBIO)·Q4 2024 Earnings Summary

Executive Summary

  • Q4 2024 revenue was $5.9M, up from $1.7M in Q4 2023, driven by the first U.S. sales of Attruby; GAAP net loss per share was $1.40 vs $0.96 YoY .
  • Attruby FDA approval on Nov 22 enabled $2.9M of net product revenue in Q4; EU approval on Feb 10 triggered a $75M milestone and tiered royalties beginning in the low-thirties percent, supporting near‑term cash inflows .
  • Year-end cash, cash equivalents, and short-term restricted cash were $681M; management expects $105M in regulatory milestone receipts in 1H 2025 (Europe, Japan) .
  • Consensus EPS and revenue estimates for Q4 were unavailable at time of query due to S&P Global API limits; no estimate comparisons are included (S&P Global data not retrieved).

What Went Well and What Went Wrong

What Went Well

  • U.S. and EU approvals and early commercial traction: “As of February 17, 2025, 1,028 unique patient prescriptions for Attruby have been written by 516 unique prescribers since FDA approval,” with category‑leading clinical results highlighted by the CCO .
  • Strong clinical differentiation: Attruby demonstrated earliest known time to separation (3 months) and substantial reductions in ACM/CVH (42% at 30 months; 46–48% reductions in composite ACM and recurrent CVH in OLE at 36–42 months) .
  • Advancing late-stage pipeline: FORTIFY (LGMD2I/R9), CALIBRATE (ADH1), and PROPEL 3 (achondroplasia) are fully enrolled with last participant–last visit expected before end of 2025 .

What Went Wrong

  • Elevated operating spend: Q4 operating costs and expenses rose to $231.9M (vs $179.2M YoY), primarily SG&A ramp for Attruby commercialization; quarterly loss from operations widened to $(226.0)M .
  • Higher financing burden: Q4 total other expense was $(40.2)M vs $7.1M in Q4 2023, reflecting increased interest expense and equity method losses .
  • Continued GAAP net losses: Q4 net loss to common shareholders was $(265.1)M vs $(168.1)M YoY, highlighting the transition-phase economics of launch amid scale-up costs .

Financial Results

Quarterly financials vs prior periods (oldest → newest)

MetricQ4 2023Q2 2024Q3 2024Q4 2024
Revenue ($USD Millions)$1.745 $2.168 $2.732 $5.882
Net Loss per Share (GAAP) ($)$(0.96) $(0.39) $(0.86) $(1.40)
Loss from Operations ($USD Millions)$(177.416) $(175.539) $(191.750) $(226.027)
Operating Costs & Expenses ($USD Millions)$179.161 $177.707 $194.482 $231.909

Revenue breakdown (Q4 2024)

Revenue ComponentQ4 2024
Total Revenue ($USD Millions)$5.882
Net Product Revenue (Attruby) ($USD Millions)$2.900
Services/Collaboration Revenue (Bayer/Kyowa Kirin)Included in total (exact amount not disclosed)

KPIs

KPIValuePeriod
Attruby prescriptions (unique patients)1,028As of Feb 17, 2025
Unique prescribers516As of Feb 17, 2025
Cash, cash equivalents & short-term restricted cash ($USD Millions)$681.2Dec 31, 2024
Expected regulatory milestones ($USD Millions)$105.01H 2025 (EU, Japan approvals)
EU approval milestone ($USD Millions)$75.0Feb 10, 2025
EU royalty structureTiered, beginning in low‑thirties percentFeb 10, 2025

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Regulatory milestones expected ($)1H 2025Not previously specified$105M expected from Europe and Japan approvalsNew
Acoramidis EU approval status1Q 2025CHMP positive opinion (Dec 13, 2024)EC approval granted Feb 10, 2025Achieved
Pipeline timing (FORTIFY, CALIBRATE, PROPEL 3)2025Enrollment ongoingFully enrolled; LPLV expected before end of 2025Maintained/clarified
Financial guidance (Revenue, OpEx, margins, OI&E, tax)2025Not providedNot providedMaintained (no formal quantitative guidance)

Earnings Call Themes & Trends

TopicQ2 2024 (Summary)Q3 2024 (Summary)Q4 2024 (Summary)Trend
Regulatory/LegalNDA filed; PDUFA 11/29/24; expanding evidence set across ISA/ESC Pre-approval prep; TRACE‑AI collaboration; intent to provide trial patients free drug for life FDA approval (Nov 22); EU approval (Feb 10); royalties/milestone structured Strengthening approvals/market access
Product performance (ATTR-CM)Early & sustained outcome benefits; 42% composite reduction; NT‑proBNP improvements Continued data updates; AI-driven screening (TRACE-AI) Launch traction: 1,028 scripts, 516 prescribers; CCO highlights 3‑month separation, 42% ACM+CVH reduction, 50% CVH reduction Accelerating launch metrics
R&D executionMultiple late-stage programs; progressing to readouts in 2025 FORTIFY, CALIBRATE, PROPEL 3 advancing; BTD for achondroplasia; RMAT for Canavan All three registrational studies fully enrolled; LPLV expected before end of 2025 Execution milestones achieved
Macro/financingCash $587M; term loan and equity financing; deconsolidation gains Cash $406M; gain on deconsolidation; continued financing activities YE cash $681M; $75M EU milestone and EU royalties; $105M expected milestones in 1H25 Improving liquidity profile
AI/Technology initiativesEvidence-generation and cardiac imaging analyses TRACE-AI Network with Yale Cardio-Data Science OLE outcomes integrated into narrative; no new AI items in PR AI collaboration established earlier; carrying through

Management Commentary

  • CEO perspective on market resonance and access: “It is exciting to see patients, physicians, and payers resonate with our message that the greater levels of TTR stabilization that Attruby delivers can be of benefit… and that the TTR protein is clinically important, not toxic.” — Neil Kumar, Ph.D., Founder & CEO .
  • CCO on clinical differentiation and launch traction: “Attruby's category-leading results - time to separation of just three months, along with a 42% reduction in all-cause mortality and recurrent hospitalizations and a 50% reduction in cardiovascular hospitalizations at 30 months - set it apart…” — Matt Outten, CCO .
  • CFO on Q3 pre-launch readiness: “We are prepared to launch acoramidis in the U.S., upon approval by the FDA, at the end of 2024 as well as to read out our three ongoing Phase 3 studies in 2025.” — Brian Stephenson, Ph.D., CFA .

Q&A Highlights

  • Launch breadth and prescriber mix: Early scripts were broadly distributed beyond centers of excellence, reflecting activation across heart failure practices (10k+ HFpEF practices), with 430 scripts and 250+ prescribers within weeks post-approval (updated metrics later exceeded in Feb) .
  • Go-to-market message: Emphasis on 3-month separation and 42% composite reduction resonating with clinicians; aim for parity access to ensure a clinical sale vs price-driven dynamics .
  • Market access cadence: Achieved ~77% parity coverage early, aided by hospitalization reductions that matter to payers; expectation to continue gaining parity across plans .
  • Timeline for investor communications: Management expects first formal earnings calls starting April/May 2025, with metrics on patients, prescribers, and payers to gauge launch health .

Note: A formal Q4 2024 earnings call transcript was not available; management’s January 13, 2025 JPM presentation and Q&A are used as the closest primary source .

Estimates Context

  • S&P Global consensus estimates for Q4 2024 EPS and revenue were unavailable at time of query due to API daily limit; press release and 8‑K did not disclose Street comparisons. Values retrieved from S&P Global were not available; thus, no beat/miss analysis vs consensus is included.
  • Given launch-phase dynamics and absence of numerical guidance, we expect Street models to emphasize Attruby uptake (scripts, prescribers), payer parity progress, and EU/Japan milestone timing (including $105M in 1H 2025) .

Key Takeaways for Investors

  • Launch traction and clinical differentiation are the near-term stock drivers: early script and prescriber breadth plus clear outcome benefits (3-month separation; 42–50% reductions) should support adoption and payer parity .
  • Cash runway strengthened by milestones and royalties: YE cash $681M with $75M EU milestone received and $105M regulatory milestones expected in 1H 2025; royalty tier begins in low‑thirties percent, de‑risking near‑term liquidity .
  • Operating leverage to watch: SG&A ramp was substantial in Q4 to support launch; monitor cost discipline vs revenue scale-up and any nonrecurring items (e.g., deal-related costs cited for FY) .
  • Pipeline optionality in 2025: Three fully enrolled Phase 3 programs (LGMD2I/R9, ADH1, achondroplasia) with LPLV expected before end of 2025 provide multiple catalysts beyond Attruby .
  • Market access parity is key: Management targets clinical sale and parity access rather than pricing battles; hospitalization reductions bolster payer rationale, smoothing reimbursement path .
  • Near-term communications: Expect first earnings calls in April/May 2025 with more detailed launch KPIs (patients, prescribers, payer metrics), providing clearer visibility into revenue trajectory .
  • EU approval achieved; Japan next: EU commercialization (via Bayer) and Japan approval in 1H 2025 are incremental geographic growth and cash flow catalysts .

Appendix: Additional Press Releases Relevant to Q4

  • FDA approval of Attruby (Nov 22, 2024): first and only near-complete TTR stabilizer with label specifying ≥90% stabilization; clinical outcomes detailed; patient access programs launched .
  • OLE outcomes (Nov 18, 2024): sustained benefit with 36% ACM reduction at Month 36 and 46–48% composite ACM/CVH reductions at Months 36–42; published in Circulation .
  • CHMP positive opinion (Dec 13, 2024): EU recommendation ahead of EC approval; benefits consistent with ATTRibute-CM .
  • Q3 financials and business update (Nov 12, 2024): pre-launch readiness, TRACE‑AI collaboration, and financial trends .