BridgeBio(BBIO) - 2025 Q2 - Quarterly Results

Second Quarter 2025 Highlights The company reported strong Q2 revenue driven by the Attruby® launch and highlighted key upcoming clinical milestones Q2 2025 Key Financial Metrics | Metric | Value (USD) | | :--- | :--- | | Total Revenue | $110.6 million | | U.S. Attruby® Net Product Revenue | $71.5 million | | Royalty Revenue | $1.6 million | | License and Services Revenue | $37.5 million | | Cash, Cash Equivalents and Marketable Securities | $756.9 million | - The commercial launch of Attruby® is accelerating, with 3,751 unique patient prescriptions written by 1,074 unique prescribers as of August 1, 2025, showing strong month-over-month growth[2] - New clinical data for Attruby® from the ATTRibute-CM study reinforced its differentiated profile, showing significant benefits for variant ATTR-CM patients and linking TTR stabilization with improved survival[2] - The company anticipates several key late-stage clinical trial readouts, including topline results for BBP-418 (LGMD2I/R9) and encaleret (ADH1) in fall 2025, and infigratinib (achondroplasia) in early 2026[2][3] Business and Operational Updates The company details strong commercial momentum for Attruby®, progress in its late-stage pipeline, and recent corporate financing activities Commercial Progress The commercial launch of Attruby® shows strong momentum with significant growth in prescriptions and revenue - Since its FDA approval in November 2024, Attruby® has achieved 3,751 unique patient prescriptions from 1,074 unique prescribers[4] - The Chief Commercial Officer stated that product revenue nearly doubled in Q2, driven by growing adoption, and expressed confidence that Attruby® will become the standard of care for ATTR-CM[6] Pipeline Overview and Key Program Updates The company is advancing its late-stage pipeline with several key clinical trial readouts expected soon Pipeline Status and Next Expected Milestones | Program | Status | Next Expected Milestone | | :--- | :--- | :--- | | Acoramidis for ATTR-CM | Approved in U.S., EU, Japan, and UK | New rapidity of response data at ESC Congress in August 2025 | | BBP-418 for LGMD2I/R9 | FORTIFY, Phase 3 study enrollment completed | Topline results in fall 2025 | | Encaleret for ADH1 | CALIBRATE, Phase 3 study enrollment completed | Topline results in fall 2025 | | Infigratinib for achondroplasia | PROPEL 3, Phase 3 study enrollment completed | Topline results in early 2026 | Attruby (acoramidis) New clinical data reinforces Attruby's differentiated profile and a primary prevention study has been initiated - A post-hoc analysis showed acoramidis reduced the annual frequency of cardiovascular hospitalization due to atrial fibrillation (AF)/atrial flutter (AFL) by 43% compared to placebo[8] - A publication in JACC showed that for each 5-mg/dL increase in serum TTR level within 28 days of starting treatment, the relative risk reduction of mortality was up to 31.6% through Month 30[8] - The ACT-EARLY study, a primary prevention trial for ATTR, has dosed its first asymptomatic participant to test if acoramidis can delay or prevent the development of variant ATTR[10] BBP-418 (for LGMD2I/R9) The registrational Phase 3 FORTIFY study has completed enrollment, with topline interim results expected in fall 2025 - The last participant visit for the FORTIFY Phase 3 trial has been achieved, with topline results from the interim analysis cohort expected in fall 2025[10] - The interim analysis will assess a surrogate endpoint biomarker (glycosylated alpha-dystroglycan) to potentially support an Accelerated Approval filing in the U.S.[10] Encaleret (for ADH1) The fully enrolled Phase 3 CALIBRATE study for ADH1 is on track for topline results in fall 2025 - The CALIBRATE Phase 3 trial is fully enrolled with 71 participants, and topline results are expected in fall 2025[10] - A Phase 2 proof-of-principle study in hypoparathyroidism showed 80% of participants achieved normal blood and urine calcium within 5 days, supporting advancement into late-stage development[10] Infigratinib (for achondroplasia) The fully enrolled Phase 3 PROPEL 3 study expects topline results in early 2026 for this highly designated drug - The PROPEL 3 Phase 3 trial is fully enrolled with 114 participants, and topline results are expected in early 2026[10] - Infigratinib has received Breakthrough Designation, Orphan Drug Designation, Fast Track Designation, and Rare Pediatric Disease Designation from the FDA for achondroplasia[14] - BridgeBio has reached regulatory alignment with the FDA to initiate clinical development for infigratinib in children with achondroplasia from birth to less than 3 years old by the end of the year[10][11] Corporate Updates The company strengthened its financial position through a partial royalty sale and a milestone payment - Received $300 million from the partial and capped sale of a portion of royalties on BEYONTTRA sales in Europe to HealthCare Royalty (HCRx) and Blue Owl Capital[14] - Received a $30 million regulatory-related milestone cash payment from Alexion for the Japan approval of BEYONTTRA[14] Financial Performance This section details the company's quarterly financial results, balance sheet, and cash flow statements Financial Summary The company reported a strong cash position and significant revenue growth driven by Attruby®, alongside increased operating expenses - The company's cash, cash equivalents, and marketable securities totaled $756.9 million as of June 30, 2025, an increase from $681.1 million at the end of 2024[12] - The increase in Q2 revenue was primarily driven by $71.5 million in net product revenue from Attruby® and a $35.3 million increase in license and services revenue, including a $30.0 million milestone from Alexion[13] - The rise in Q2 operating expenses was mainly due to a $69.6 million increase in SG&A expenses to support the commercial launch of Attruby®[16] Q2 2025 vs Q2 2024 Financial Results (in thousands) | Metric | Q2 2025 | Q2 2024 | | :--- | :--- | :--- | | Total Revenues, Net | $110,565 | $2,168 | | Total Operating Costs and Expenses | $244,843 | $177,707 | | Net Loss Attributable to Common Stockholders | ($181,903) | ($73,456) | | Net Loss Per Share | ($0.95) | ($0.39) | Condensed Consolidated Financial Statements The financial statements detail revenue growth, a strengthened cash position, and significant financing activities Condensed Consolidated Statements of Operations Quarterly revenue surged due to Attruby® sales, improving the loss from operations despite a higher net loss Q2 2025 Statement of Operations Highlights (in thousands) | Line Item | Q2 2025 | Q2 2024 | | :--- | :--- | :--- | | Total revenues, net | $110,565 | $2,168 | | Total operating costs and expenses | $244,843 | $177,707 | | Loss from operations | ($134,278) | ($175,539) | | Total other income (expense), net | ($47,380) | $99,995 | | Net loss attributable to common stockholders | ($181,903) | ($73,456) | Condensed Consolidated Balance Sheets The balance sheet reflects a stronger cash position and increased total assets, alongside higher liabilities from new financing Balance Sheet Highlights (in thousands) | Account | June 30, 2025 | Dec 31, 2024 | | :--- | :--- | :--- | | Cash, cash equivalents and marketable securities | $756,892 | $681,101 | | Total assets | $1,080,190 | $919,338 | | 2031 Notes, net | $563,597 | — | | Term loan, net | — | $437,337 | | Total BridgeBio stockholders' deficit | ($1,787,860) | ($1,467,904) | Condensed Consolidated Statements of Cash Flows Significant cash inflows from financing activities offset cash used in operations, resulting in a net cash increase Six-Month Cash Flow Summary (in thousands) | Cash Flow Activity | H1 2025 | H1 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | ($279,916) | ($144,834) | | Net cash provided by (used in) investing activities | ($14,597) | $25,792 | | Net cash provided by financing activities | $362,369 | $273,819 | | Net increase in cash, cash equivalents and restricted cash | $67,856 | $154,777 |