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BridgeBio Pharma, Inc. (BBIO)·Q3 2024 Earnings Summary

Executive Summary

  • Q3 2024 was an execution-heavy set-up quarter ahead of acoramidis (Attruby) approval: revenue was $2.7M, GAAP EPS was $(0.86), and operating expenses rose as BBIO readied commercialization and advanced late-stage programs .
  • Operating costs increased due to commercialization readiness (marketing, advertising, salesforce build) and pipeline advancement; other income turned positive on gains from deconsolidations and securities marks .
  • Key catalysts were reiterated/achieved: PDUFA Nov 29; completion of FORTIFY enrollment; CALIBRATE screening completion; FDA Breakthrough Therapy for infigratinib; RMAT for BBP-812 .
  • Post-quarter, FDA approved acoramidis as Attruby; management highlighted near-complete stabilization on label, 42% reduction in composite CV hospitalization and death at 30 months, and robust access/pricing programs—likely a major stock driver into commercialization .

What Went Well and What Went Wrong

  • What Went Well

    • Regulatory and pipeline momentum: acoramidis NDA accepted (PDUFA Nov 29), late-cycle meeting complete; FORTIFY enrollment completed; CALIBRATE screening completed; infigratinib received Breakthrough Therapy; BBP-812 received RMAT .
    • ATTRibute-CM data depth: additional analyses showed 42% reduction in ACM+recurrent CVH events and 50% reduction in CVH at 30 months; supports clinical impact narrative ahead of launch .
    • Balance sheet flexibility: $405.7M cash/short-term restricted cash at 9/30, with expected $500M U.S. approval milestone and $105M EU/JP regulatory milestones tied to acoramidis approvals .

  • What Went Wrong

    • Minimal Q3 revenue ($2.7M) with loss from operations $(191.8)M; GAAP net loss $(162.0)M, reflecting heavy OPEX pre-launch and reduced services revenue versus prior year .
    • SG&A stepped up meaningfully (to support commercialization), pressuring near-term P&L; SG&A +$33.0M YoY in Q3 and +$91.1M YTD YoY .
    • Gene therapy portfolio rationalization: despite scientific advances in CAH (BBP-631), BBIO will reduce gene therapy budget by >$50M and seek partners, reflecting capital allocation trade-offs .

Financial Results

MetricQ3 2023Q1 2024Q2 2024Q3 2024
Revenue ($M)$4.091 $211.120 $2.168 $2.732
Loss from Operations ($M)$(157.692) $0.343 $(175.539) $(191.750)
Other Income (Expense), net ($M)$(21.796) $(36.503) $99.995 $27.496
Net Loss Attributable to Common ($M)$(176.999) $(35.216) $(73.456) $(162.040)
GAAP EPS (diluted)$(1.08) $(0.20) $(0.39) $(0.86)
Cash, Cash Eq. + ST Restricted Cash ($M, period-end)N/A$519.8 $587.2 $405.7

Notes: Q1 revenue reflects upfront/license recognition (Bayer/Kyowa Kirin); Q3 revenue minimal as services recognition declined with Navire-BMS termination effective June 2024 .

Operating Expenses detail

Operating Costs ($M)Q3 2023Q1 2024Q2 2024Q3 2024
R&D and other$125.734 $141.570 $115.293 $121.042
SG&A$35.777 $65.807 $59.523 $68.819
Restructuring/Impairment/Related$0.272 $3.400 $2.891 $4.621
Total Operating Costs & Expenses$161.783 $210.777 $177.707 $194.482

Select KPIs

KPIQ1 2024Q2 2024Q3 2024
Total Other Inc/(Exp), net ($M)$(36.503) $100.0 $27.5
Stock-based Comp ($M, quarter)$28.850 $21.451 $27.131
Cash Paid for Interest ($M, YTD/period)$35.315 (Q1) $49.046 (H1) $78.236 (9M)

Segment breakdown: Not applicable; BBIO does not report revenue by operating segments in these releases .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent (Q3)Change
Acoramidis (U.S.) PDUFA2024Nov 29, 2024 (Q2) Nov 29, 2024; late-cycle complete Maintained/advanced regulatory process
U.S. approval tied milestoneUpon FDA approvalNot previously quantified in Q2 PR$500M expected under royalty funding agreement New/added specificity
EU/JP regulatory milestonesUpon EU/JP approvalsNot detailed in Q2 PR$105M aggregate expected New/added specificity
FORTIFY (BBP-418)Enrollment"Enrollment completion in 2024" Enrollment completed Achieved/advanced
CALIBRATE (encaleret)Enrollment"Enrollment completion in 2024" Screening completed; enrollment completion 2024 On track
PROPEL 3 (infigratinib)EnrollmentCompletion in 2024 Continues to enroll; completion anticipated by year-end Maintained
Phase 3 readouts20253 Phase 3 readouts in 2025 (implied) Reiterated: 3 Phase 3 readouts in 2025 Maintained

No formal numerical FY revenue/margin/OpEx guidance was provided in Q3 materials -.

Earnings Call Themes & Trends

Note: A Q3 2024 earnings call transcript was not available in our document set; themes reflect Q1/Q2/Q3 company materials.

TopicPrevious Mentions (Q-2 and Q-1)Current Period (Q3 2024)Trend
AI/Technology initiativesNo specific AI program disclosures in Q1/Q2 PRs - -TRACE-AI Network collaboration for large-scale federated AI screening in ATTR-CM New focus introduced
Regulatory milestones (acoramidis)EMA MAA accepted; U.S. PDUFA 11/29/24 reiterated NDA accepted; late-cycle complete; PDUFA 11/29/24 Steady progress; de-risking
Product efficacy narrative (acoramidis)CMR imaging consistent with clinical improvement (Q1); multiple ISA/ESC analyses (Q2) - -Additional ESC/HFSA analyses (42% composite reduction; QoL benefits) Strengthening evidence base
R&D execution (enrollment)Aim to fully enroll three Phase 3s in 2024 FORTIFY enrollment completed; CALIBRATE screening completed; PROPEL 3 continues -On/above plan
Pipeline regulatory designationsNotable progress in Q2 for infigratinib (data) Breakthrough Therapy (infigratinib); RMAT (BBP-812) Upgraded regulatory momentum
Portfolio allocationOncology spin-out BBOT funded (Q1) Gene therapy budget reduced >$50M; partner sought for CAH Capital discipline sharpened

Management Commentary

  • “I’m excited for the upcoming opportunity to serve patients with ATTR-CM in the commercial marketplace… proud to have released our first case study in The Journal of Portfolio Management” — Neil Kumar, CEO .
  • “We are prepared to launch acoramidis in the U.S., upon approval by the FDA, at the end of 2024… and to read out our three ongoing Phase 3 studies in 2025.” — Brian Stephenson, CFO .
  • “It is our intent to honor the courage of our U.S. clinical trial patients by providing them acoramidis free for life.” — Acoramidis program update .
  • On post-hoc outcomes: “A 42% reduction in composite ACM and recurrent CVH events… at 30 months” — Late-stage update .
  • Post-quarter approval webcast: “Attruby… is the only oral stabilizer with… near complete stabilization in the label… 42% relative risk reduction against hospitalization and death; 50% reduction in CV hospitalization at 30 months.” — Neil Kumar .

Q&A Highlights

  • The Q3 2024 earnings call transcript was not available in the document corpus; therefore, Q&A themes and clarifications cannot be summarized. We will update if the transcript becomes available.

Estimates Context

  • Wall Street consensus (S&P Global) for Q3 2024 revenue and EPS could not be retrieved due to an SPGI daily request limit; as a result, we cannot assess beat/miss versus consensus at this time. We will refresh when access is restored.
  • Reported results: revenue $2.7M and GAAP EPS $(0.86) for Q3 2024 .

Key Takeaways for Investors

  • Near-term: Post-quarter FDA approval of acoramidis (Attruby) transforms BBIO into a commercial-stage story in a large market; label highlights near-complete stabilization and hard outcomes reduction—key for uptake; strong access/pricing stance may accelerate adoption .
  • Cash inflows: Approval triggers $500M milestone under the royalty funding agreement; EU/JP approvals would add $105M aggregate—material liquidity catalysts alongside $405.7M cash/short-term restricted cash at Q3 end .
  • 2025 pipeline readouts: Three Phase 3 readouts expected (LGMD2I/R9, ADH1, achondroplasia)—multiple value-inflection points beyond acoramidis -.
  • Infigratinib differentiation: FDA Breakthrough Therapy Designation plus statistically significant AHV and proportionality signals at low dose underpin potential best-in-class oral profile; enrollment on track - .
  • Capital allocation: Operating expense intensity reflects launch prep and late-stage advancement; gene therapy spend trimmed by >$50M, with partnering pursued for CAH to preserve focus/capital .
  • Evidence strength: Recurrent event analyses and OLE data deepen the clinical impact narrative for acoramidis—supporting share gains versus existing therapies .
  • Watch items: Early launch metrics for Attruby (switching dynamics, TTR stabilization monitoring, hospitalization trends), EU/JP regulatory timelines, and 2025 Phase 3 data cadence.

Appendix: Additional Q3-Relevant Press Releases (select)

  • FORTIFY (BBP-418) enrollment completed; interim readout 2025; potential U.S. Accelerated Approval via αDG surrogate -.
  • Infigratinib (achondroplasia) received FDA Breakthrough Therapy Designation; PROPEL 3 enrollment targeted to complete by year-end -.
  • BBP-812 (Canavan) received RMAT; exploring Accelerated Approval pathway; positive functional signals reported -.
  • CAH gene therapy BBP-631: first-ever endogenous cortisol production increases in CAH; BBIO to reduce gene therapy budget and seek partners -.