Core Insights - Acoramidis has shown significant early and sustained clinical efficacy in reducing cumulative cardiovascular outcomes in patients with transthyretin amyloidosis cardiomyopathy (ATTR-CM) [1][2][3] Group 1: Clinical Efficacy - Acoramidis reduced cumulative cardiovascular mortality (CVM) or recurrent cardiovascular-related hospitalizations (CVH) by 49% through Month 30 compared to placebo, with a p-value of less than 0.0001 [1][3] - At Month 30, 53 events were avoided per 100 treated participants, with a 95% confidence interval of 29 to 79 [1][3] - Continuous treatment with acoramidis at Month 42 resulted in a 45% reduction in CVM compared to a switch from placebo to acoramidis, with a p-value of 0.0011 [3] Group 2: Patient Population Insights - Acoramidis demonstrated a consistent mitigation of NT-proBNP levels in patients with variant ATTR-CM, starting from Month 3 and continuing through Month 30 [3] - The findings highlight the importance of early and continuous treatment with acoramidis, regardless of TTR genotype, in both wild-type and variant ATTR-CM patients [3] Group 3: Regulatory Approvals - Acoramidis is approved as Attruby® by the U.S. FDA and as BEYONTTRA® by the European Commission, Japanese Pharmaceuticals and Medical Devices Agency, and the UK Medicines and Healthcare Products Regulatory Agency [4][5] Group 4: Future Developments - Additional data on the benefits of Attruby for ATTR-CM patients is planned for future medical meetings [4]

Core Insights - Acoramidis has shown a significant reduction in cardiovascular mortality (CVM) risk by 44% over 42 months post-randomization, establishing a new standard for outcomes in patients with transthyretin amyloid cardiomyopathy (ATTR-CM) [1][2] - The treatment also demonstrated a 46% hazard reduction in the composite outcome of CVM or first cardiovascular hospitalization (CVH) over the same period [1] - Acoramidis has been approved by the U.S. FDA as Attruby and by the European Commission, Japanese Pharmaceuticals and Medical Devices Agency, and UK Medicines and Healthcare Products Regulatory Agency as BEYONTTRA [1][5] Efficacy and Clinical Benefits - In the ATTRibute-CM study, acoramidis exhibited the fastest benefit observed in any Phase 3 study for ATTR-CM, with significant improvements noted as early as 3 months [1] - At Month 30, there was a 42% reduction in composite all-cause mortality (ACM) and recurrent CVH events compared to placebo [1] - A 50% reduction in the cumulative frequency of CVH events was also reported at Month 30 relative to placebo [1] - Acoramidis treatment resulted in improved or stable NT-proBNP levels in approximately 50% of participants at Month 30, compared to fewer than 20% in the placebo group, indicating meaningful clinical improvement [3] - The treatment also showed a greater proportion of patients with stable or improved NAC Stage at Month 30 compared to placebo, suggesting better disease stabilization [3] Regulatory and Commercial Developments - BridgeBio Pharma has entered into an exclusive licensing agreement with Bayer Consumer Care AG for the commercialization of BEYONTTRA in Europe [4] - Future medical meetings are planned to present additional data on the benefits of Attruby for ATTR-CM patients [5]

Core Viewpoint - BridgeBio Pharma has entered into a royalty financing agreement, selling a portion of its royalties from BEYONTTRA sales in Europe for $300 million, which will provide immediate capital to support its operations and product launches [1][2][4]. Financial Details - The agreement allows BridgeBio to receive $300 million in exchange for 60% of royalties on the first $500 million of annual BEYONTTRA net sales in Europe, with total payments capped at 1.45 times the initial investment [3][4]. - BridgeBio has previously received $210 million in upfront and regulatory milestone payments from Bayer for BEYONTTRA and anticipates an additional $75 million in near-term milestone payments [4]. Product Information - BEYONTTRA is an orally administered stabilizer of transthyretin (TTR) for treating wild-type or variant transthyretin amyloidosis in adult patients with cardiomyopathy (ATTR-CM) [6][8]. - Acoramidis, the active ingredient in BEYONTTRA, has shown significant clinical benefits, including a 42% reduction in composite adverse cardiovascular events and a 50% reduction in cumulative frequency of cardiovascular events at 30 months compared to placebo [6]. Strategic Partnerships - The partnership with HealthCare Royalty and Blue Owl Capital is aimed at strengthening BridgeBio's balance sheet to support the launch of Attruby and its pipeline of genetic medicines [2][3]. - HCRx has expressed confidence in the commercial potential of BEYONTTRA and is committed to supporting innovation in the biopharmaceutical industry through this investment [3].

Core Insights - Acoramidis has shown significant clinical benefits in reducing the incidence of atrial fibrillation (AF) and cardiovascular-related hospitalizations in patients with transthyretin amyloid cardiomyopathy (ATTR-CM) [1][4][5] - The drug has received regulatory approvals in multiple regions, including the U.S. and Europe, indicating its potential as a treatment option for ATTR-CM [1][6] Group 1: Clinical Outcomes - In a post-hoc analysis of the ATTRibute-CM study, acoramidis reduced the annual frequency of cardiovascular hospitalizations (CVH) due to AF/atrial flutter (AFL) by 43% compared to placebo [1][4] - The incidence of new-onset AF/AFL was reduced by 17% in patients with no prior history of AF when treated with acoramidis [1][4] - A 42% reduction in composite all-cause mortality (ACM) and recurrent CVH events was observed at Month 30 relative to placebo [3] - Acoramidis treatment led to a greater than 50% reduction in ACM and CVH in participants with variant ATTR-CM compared to placebo [7] Group 2: Functional Capacity and Quality of Life - Patients with variant ATTR-CM treated with acoramidis showed a clinically significant slower decline in functional capacity and quality of life compared to placebo [7] - At Month 30, the mean difference in the 6-minute walk distance was 86.7 meters in favor of acoramidis (p = 0.0048) [7] - The KCCQ-OS score change from baseline at Month 30 was 20.3 points higher in the acoramidis group compared to placebo (p = 0.0019) [7] Group 3: Regulatory Approvals and Future Directions - Acoramidis is approved as Attruby™ by the U.S. FDA and as BEYONTTRA by the European Commission and other regulatory agencies [1][6] - The company plans to present more data on the benefits of acoramidis for ATTR-CM patients at future medical meetings [6]

Core Insights - The study of acoramidis in the ATTRibute-CM trial indicates that early and sustained increases in serum transthyretin (TTR) levels are associated with improved survival outcomes in patients with transthyretin amyloid cardiomyopathy (ATTR-CM) [1][2][5] - Acoramidis, a near-complete TTR stabilizer, has shown significant clinical benefits, including reductions in all-cause mortality (ACM) and cardiovascular-related hospitalizations (CVH) [1][6][12] Group 1: Clinical Findings - A 5-mg/dL increase in serum TTR level within 28 days of treatment initiation correlates with a relative risk reduction of mortality of up to 31.6% through Month 30 [1][5] - The ATTRibute-CM study is the first to demonstrate a direct link between increased serum TTR and survival in ATTR-CM patients [1][2] - Acoramidis treatment resulted in a mean increase of 9.1 mg/dL in serum TTR levels within 28 days, which was sustained throughout the 30-month treatment period [5][6] Group 2: Statistical Outcomes - The study reported a 42% reduction in composite ACM and recurrent CVH events relative to placebo at Month 30 [4] - A 50% reduction in the cumulative frequency of CVH events was observed relative to placebo at Month 30 [4] - The analysis showed that the early increase in serum TTR levels was associated with reduced ACM, independent of baseline risk factors [5][6][12] Group 3: Regulatory Approvals - Acoramidis is approved as Attruby™ by the U.S. FDA and as BEYONTTRA by the European Commission, Japanese Pharmaceuticals and Medical Devices Agency, and UK Medicines and Healthcare Products Regulatory Agency [1][7] Group 4: Company Overview - BridgeBio Pharma, Inc. focuses on developing transformative medicines for genetic diseases and has a pipeline that includes advanced clinical trials [10]

Core Insights - BridgeBio Pharma reported $36.7 million in net product revenue for Attruby in its first full quarter, with 2,072 unique patient prescriptions written by 756 prescribers as of April 25, 2025 [1][2] - The company has made significant progress in its clinical trials, including the full enrollment of the observational run-in study for hypochondroplasia Phase 2 trial ahead of schedule [1][6] - BridgeBio ended the quarter with $540.6 million in cash and cash equivalents, excluding anticipated regulatory milestone payments of $105 million for ex-U.S. approvals of BEYONTTRA [1][9] Commercial Progress - The first full quarter of Attruby net product revenue was $36.7 million, with 2,072 unique patient prescriptions written by 756 healthcare providers since FDA approval in November 2024 [2][13] - The Chief Commercial Officer highlighted a 42% reduction in all-cause mortality and a 50% decrease in cardiovascular hospitalizations at 30 months for patients treated with Attruby [3] Pipeline Overview - Acoramidis for ATTR-CM is approved in the U.S., EU, Japan, and UK, with the first participant in the ACT-EARLY Phase 3 trial expected to be dosed in 2025 [4] - BBP-418 for LGMD2I/R9 and encaleret for ADH1 have completed enrollment in their Phase 3 studies, with topline results expected in the second half of 2025 [4][6] - Infigratinib for achondroplasia is fully enrolled, with topline results anticipated in early 2026 [4][6] Key Program Updates - Attruby has shown strong clinical efficacy and safety, contributing to its growth in the ATTR-CM treatment paradigm [5][6] - The Phase 2 proof-of-principle study of encaleret in hypoparathyroidism showed 78% of participants achieving normal calcium levels within 5 days, with plans to advance to a registrational study in 2026 [6][7] Financial Updates - Cash and cash equivalents decreased to $540.6 million as of March 31, 2025, primarily due to operating activities and loan repayments [9][10] - Total revenues for the three months ended March 31, 2025, were $116.6 million, down from $211.1 million in the same period the previous year, mainly due to a decrease in license and services revenue [10][11] - The company recorded a net loss attributable to common stockholders of $167.4 million for the quarter, compared to a loss of $35.2 million for the same period in 2024 [20]