BridgeBio — Third Quarter 2026 Earnings Summary

Financial Performance:

• Total third quarter revenues were $353.2 million, compared to $120.7 million in the same period of 2025, representing a year-over-year increase of $232.5 million.
• U.S. Attruby net product revenue was $253.2 million, up approximately $145 million year-over-year and $31 million sequentially.
• License and services revenue was $79.3 million, driven by a one-time $75.0 million sales milestone from Bayer, compared to $8.3 million in the prior year period.
• Royalty revenue was $20.5 million, up $16.2 million year-over-year, primarily from BEYONTTRA sales in the EU and Japan.
• Loss from operations was $11.6 million for the quarter, compared to a loss of $145.2 million in the prior year period.
• Net loss attributable to common stockholders was $83.0 million for the quarter, compared to $182.7 million in the prior year period.
• Net loss per share was $0.42 for the quarter, compared to $0.95 in the prior year period.
• Cash, cash equivalents, and marketable securities totaled $1.5 billion as of September 30, 2026, compared to $587.5 million as of December 31, 2025.
• Total operating costs and expenses were $364.8 million for the quarter, up $98.9 million year-over-year, driven by increases in SG&A ($63.2 million), R&D ($30.6 million), and cost of revenues ($13.9 million).
• Stock-based compensation for the quarter was $39.9 million, compared to $35.3 million in the prior year period.
• Total other income (expense), net was $(47.6) million for the quarter, compared to $(41.3) million in the prior year period.

Guidance and Future Outlook:

• The Company intends to submit a Marketing Authorization Application (MAA) to the EMA for BBP-418 in the first half of 2028.
• Potential EU approval for oral infigratinib is expected in the second half of 2027.
• Potential EU approval for encaleret is expected in the second half of 2027.
• Topline data for the RECLAIM-HP Phase 3 study for encaleret in chronic hypoparathyroidism is expected in early 2028.
• Clinical studies for BBP-418 in individuals under 12 years of age are planned for the first half of 2027.
• The Company plans to submit an Investigational New Drug (IND) application for BBP-717 in 2027.
• Management stated that cash, cash equivalents, and marketable securities fully fund all three launches and expansion indications.

Business Segments and Product Lines:

• Attruby (acoramidis): Growth was led by the treatment-naïve segment, with increases in newly diagnosed patients starting treatment and market share. Real-world evidence shows an 18% lower risk of death, hospitalization, new atrial fibrillation, or diuretic escalation versus tafamidis, and a 25% lower risk of hospitalization. Cardiac MRI data suggests potential reversal of structural damage through 42 months, with up to half of completers achieving clinically meaningful improvement. The first participant was dosed in the Phase 3b/4 ASCEND-ATTR study.
• BBP-418: Has a PDUFA date of November 27, 2026, with Priority Review. The U.S. field team has reached over 70% of MDA Care Centers, with a target of 90% by PDUFA. Phase 3 FORTIFY trial data showed 100% of treated participants with elevated troponin I returned to normal range versus 40% on placebo, and 54% had stable or improved heart pumping function versus 25% on placebo.
• Oral infigratinib: Has a PDUFA date of February 4, 2027, with Priority Review. The U.S. field team is fully staffed. Phase 3 PROPEL 3 data showed a 38% lower rate of ear infections and stable sleep apnea measures compared to placebo. The Phase 2/3 ACCEL study for hypochondroplasia is expanding to higher doses.
• Encaleret: Has a PDUFA date of May 8, 2027, with Priority Review. The U.S. field team is fully deployed, and over 600 genetically confirmed patients have been identified. Phase 3 CALIBRATE data showed a significant increase in kidney function (eGFR) and 100% of participants reported improvement in at least one ADH1 symptom. The first participant was dosed in the RECLAIM-HP study for chronic hypoparathyroidism.
• BBP-717: Nominated as a development candidate for ATTR-CM to deplete amyloid deposits, with an IND submission planned for 2027.

Market and Competitive Landscape:

• Real-world evidence differentiates acoramidis from tafamidis, with a first peer-reviewed comparison showing a 34% reduction in clinical worsening.
• BBP-418 is positioned as the first and only approved therapy for LGMD2I/R9, with no existing approved treatments.
• Oral infigratinib is the only therapeutic option in development for achondroplasia holding Breakthrough Therapy Designation and is positioned as the first approved oral therapy for the condition.
• Encaleret is positioned as the first approved therapy specifically indicated for ADH1 and the only oral therapy in development for chronic hypoparathyroidism to normalize both blood and urine calcium.
• The chronic hypoparathyroidism market represents an estimated population of 200,000 patients in the U.S. and EU.

Risks and Challenges:

• Forward-looking statements are subject to risks including clinical trial results not indicating final data, target patient populations not being as large as anticipated, and regulatory agencies not agreeing with approval strategies.
• Risks include potential delays in pre-commercial activities, commercial launches, or operational execution not occurring on anticipated timelines.
• Real-world experience with Attruby may not translate into differentiated clinical, commercial, or market outcomes.
• Risks include the ability to obtain additional funding, volatility in share price, and impacts from macroeconomic and geopolitical events.
• Specific risks include the potential for the share repurchase program to be modified, suspended, or discontinued.

Management Commentary and Tone:

• CEO Neil Kumar expressed being "heartened" by consistent evidence that acoramidis outperforms tafamidis on survival and hospitalization outcomes, describing the moment as "particularly special" due to three upcoming PDUFA dates.
• CCO Matt Outten noted that Attruby delivered "another quarter of sequential growth" driven by first-line share gains and that the company's field teams are "hired and ready" for the upcoming launches.
• Management highlighted the significance of the upcoming approvals for BBP-418, infigratinib, and encaleret as "first for communities that have waited far too long."

Other Key Points:

• The Company issued $632.5 million in 2033 Notes during the nine months ended September 30, 2026.
• The Company issued $575.0 million in 2031 Notes during the nine months ended September 30, 2025.
• The Company repurchased $252.5 million of common stock during the nine months ended September 30, 2026.
• The Company issued $933.9 million in preferred stock during the nine months ended September 30, 2026.
• The Company paid $2.7 million in preferred stock dividends during the nine months ended September 30, 2026.
• The Company launched "Type Hype," a patient-facing campaign to encourage genetic testing for LGMD.
• The Company presented data on acoramidis at the Heart Failure Society of America Annual Scientific Meeting 2026 and the European Society of Cardiology Congress 2026.
• The Company presented data on BBP-418 at the World Muscle Society Congress 2026.
• The Company presented data on oral infigratinib at the Annual European Society for Paediatric Endocrinology Meeting 2026 and the ASBMR 2026 Annual Meeting.
• The Company presented data on encaleret at the American Society of Nephrology Kidney Week 2026 and the ASBMR 2026 Annual Meeting.
• A conference call and webcast to discuss results was held on October 29, 2026.