BridgeBio Pharma, Inc. (BBIO) Earnings

Management highlights

### Portfolio and Commercial Progress - Atruvi (ATTR-CM treatment) grew 23% quarter-over-quarter, making it the fastest growing brand in the ATTR-CM space. Growth is driven entirely by first-line treatment-naive patients, with 2-3 percentage point of first-line share growth quarter-over-quarter; the second-line switch segment has normalized to a lower steady state after post-launch forced switching inflated volumes in prior quarters. - New clinical data published in Q2 2026 confirms Atruvi delivers the first ever documented direct kidney protection in ATTR-CM patients, with hazard ratios for all-cause mortality/cardiovascular hospitalization of 0.42 and cardiovascular hospitalization alone of 0.34, matching the kidney protection benefit profile of SGLT2 inhibitors. Multiple independent real-world evidence studies confirm Atruvi delivers statistically significant 34-37% reductions in cardiovascular events and hospitalizations relative to Pfizer's partial stabilizer defamitis, with clinical separation observed as early as 30 days. - The Phase III CardioTransform trial of combination knockdown + stabilizer therapy failed to meet its primary endpoint, eliminating the scientific case for frontline combination therapy and reinforcing stabilizer monotherapy as the standard of care. ### Late-Stage Regulatory and Launch Progress - All three of Bridge Bio's late-stage pipeline programs have submitted NDAs to the FDA: 1. BBP-418 (LGMD2I): NDA accepted with priority review, PDUFA date November 27, 2026, no advisory committee planned. It would be the first approved therapy for LGMD2I, which affects ~1,000 patients in the U.S. Commercial teams are fully hired, trained, and in the field, with payer outreach and patient identification activities ongoing. 2. Incalaret (ADH1): NDA accepted, priority review granted, PDUFA date May 8, 2027, no advisory committee planned; MAA submitted to the EMA. It would be the first approved therapy for ADH1, with over 2,200 patients identified to date. A Phase III trial for the broader chronic hypoparathyroidism indication (200,000 patients in the U.S./EU, a potential blockbuster opportunity) has commenced site activation and patient screening, with readout expected in 18 months. 3. Infogratinib (achondroplasia): NDA submitted after positive Phase III results published in the *New England Journal of Medicine*, targeting MAA submission in Q4 2026 and approval in mid-2027. It is the first oral once-daily treatment for achondroplasia, with demonstrated efficacy that addresses key unmet need in a market with existing injectable competitors. Commercial teams are fully built out for launch. ### Early Pipeline Progress - Gondola Bio (in which Bridge Bio retains an ownership stake) reported positive Phase 2a data for its EPP program, and will initiate a Phase 2b/3 trial in Q3 2026 that could form the basis for regulatory approval if successful. The broader pipeline includes 17 programs across indications including ADPKD, Alpha-1 antitrypsin deficiency, neurofibromatosis type 1, and CMT1A, with 5 new INDs expected by the end of 2026 and 8 clinical proof-of-concept readouts expected in 2027-2028. ### Financial Position - Total Q2 2026 revenue was $243.7 million, up 120% year-over-year. Operating loss was $107.1 million, a 20% improvement year-over-year. Post-quarter, Bridge Bio closed a $1 billion preferred equity financing, bringing total cash/equivalents to ~$1.7 billion, enough to fund all planned operations and three upcoming launches.

Guidance

- Atruvi is on track to reach blockbuster (>$1 billion) annual worldwide sales in 2026, maintaining prior guidance for 30-40% annual sales growth. - Management expects Atruvi's first-line share growth will accelerate over the next 12-18 months, with clinical differentiation from new kidney protection and real-world evidence data driving share gains starting 6-9 months after data publication. - Five new INDs are expected by the end of 2026, with 8 clinical proof-of-concept readouts scheduled for 2027-2028. - Bridge Bio expects to reach breakeven profitability and sustainable cash flow generation by 2027, maintaining prior guidance for steady operating loss improvement as Atruvi's margin expansion offsets pre-launch investments for the three new programs. - Infogratinib peak market share in achondroplasia is expected to exceed 65%, maintaining prior guidance.

Segment performance

Bridge Bio reports all commercial revenue in Q2 2026 from its single commercial product segment, Atruvi (acaramidase): - Atruvi net product revenue: $222.4 million, up 211% year-over-year (from $71.5 million in Q2 2025), with a sequential increase of over $35 million quarter-over-quarter. Atruvi revenue represented 91.26% of Bridge Bio's total Q2 2026 revenue of $243.7 million. Other revenue segments: - Royalty revenue: $15.4 million (up from $1.6 million YoY), 6.32% of total revenue, primarily from Biantra sales in the EU and Japan. - License and services revenue: $5.8 million (down from $37.4 million YoY, which included a $30 million one-time regulatory milestone in Q2 2025), 2.38% of total revenue.

Risks & headwinds

- Actual clinical and commercial results may differ from current expectations due to inherent uncertainty in FDA/EMA regulatory review, even with positive prior interactions with agencies. - First-line ATTR-CM market remains competitive, and there is uncertainty around how physicians will digest the CardioTransform data and new Atruvi kidney data, which could impact the timing and magnitude of share gains. - Patient identification is a core driver of revenue for all three rare disease pipeline programs, and slower than expected identification of undiagnosed patients could delay commercial ramp. - While the clinical data for Atruvi's kidney protection is strong, it is new, and it remains uncertain how much it will change physician prescribing behavior over the near term. - The achondroplasia market has two existing approved competitors, and market adoption of infogratinib could be slower than expected if provider/patient switching behavior is lower than anticipated.

Analyst Q&A

• Q: What drives the consistent first-line growth of Atruvi, and how will the CardioTransform trial failure impact Atruvi's first-line share going forward?

  A: Atruvi's growth to date is rooted in its well-established clinical differentiation, including rapid separation from placebo and large reductions in hospitalization rates. New data including real-world evidence, kidney protection, and the CardioTransform failure reinforce this story, adding momentum for future share growth. Management expects stabilizer first-line therapy will grow as a share of the overall ATTR-CM market, with Atruvi (a near-complete stabilizer) positioned to capture disproportionate share. The full impact of new data will take 6-9 months to pull through into sales, but management expects accelerating first-line growth over the next 12-18 months.

• Q: Pfizer has cut net prices via new payer contracts for its competing ATTR-CM product. Do you need to respond with price cuts to maintain share?

  A: Management does not plan to respond to aggressive price cuts from Pfizer, as they believe clinical differentiation will carry share and access. They note the large independent data confirming Atruvi reduces hospitalizations by 34% relative to Pfizer's product, which is meaningful for payers managing costs for sick patient populations. They expect long-term parity in access between the two products, with Atruvi winning on clinical differentiation rather than price competition.

• Q: How important is the new Atruvi kidney protection data for prescribing, and how will Atruvi perform after Pfizer's product goes generic?

  A: The kidney data is brand new, so its full impact will emerge over the next 2-3 quarters, but it is highly meaningful to physicians: ~50% of ATTR-CM patients have some level of kidney impairment, and the data also explains Atruvi's early onset of efficacy. Management expects Atruvi will continue growing even after Pfizer's product goes generic, because of its clear clinical differentiation, stakeholder economics that do not strongly favor generic versions, and potential upside from increased relative share of voice if Pfizer stops promotion post-loss of exclusivity.

• Q: What has regulatory engagement been like for the three new NDAs, and how do you expect review timelines to proceed?

  A: All three programs completed rigorous placebo-controlled RCTs (the gold standard for rare disease) with strong p-values and clean safety profiles, leading to very productive interactions with the FDA. The FDA has accepted all three NDAs, granted priority review to two, and not scheduled advisory committees for any, indicating a healthy regulatory relationship. Engagement with the EMA has also been positive to date.

• Q: How does the failure of CardioTransform change your peak share assumption for Atruvi, which previously assumed a 30-40% peak share in a four-player combination market?

  A: Management notes CardioTransform has eliminated the scientific case for combination therapy, which should be positive for Atruvi's peak share as a leading stabilizer. However, they will not update the peak share assumption until after full CardioTransform data is presented at ESC and physicians have had time to digest the results, so no update is provided at this time.