Core Insights - Encaleret demonstrated significant efficacy in normalizing blood and urine calcium levels in post-surgical hypoparathyroidism patients, with 80% achieving normal levels within 5 days of treatment initiation compared to 0% on conventional therapy at baseline [1][6] - The treatment was well-tolerated, with no serious adverse events reported during the study [1] - BridgeBio plans to initiate a registrational clinical study for encaleret in chronic hypoparathyroidism in 2026 based on the promising Phase 2 results [1][3] Company Overview - BridgeBio Pharma, Inc. is focused on developing transformative medicines for genetic diseases, with a pipeline that includes early science to advanced clinical trials [5] - The company was founded in 2015 and aims to leverage advances in genetic medicine to expedite patient care [5] Study Details - The Phase 2 proof-of-concept study evaluated the PTH-independent effects of encaleret on renal calcium handling in ten participants with post-surgical hypoparathyroidism, administered at 162 mg twice daily for up to 5 days [2] - Calcitriol was stopped one day prior to the first dose, and calcium levels were titrated based on blood calcium after starting encaleret [2] Additional Findings - Encaleret treatment resulted in a rapid and sustained reduction in fractional excretion of calcium in nine participants, supporting its potential as an orally-administered treatment option for chronic hypoparathyroidism [6] - Data from preclinical studies of infigratinib were also presented, showing significant improvements in bone growth and skull development in relevant mouse models, indicating broad potential for treating skeletal conditions [4]

Core Insights - BridgeBio Pharma, Inc. is hosting an investor webinar on September 10, 2025, focusing on its Phase 3 clinical trial for autosomal dominant hypocalcemia type 1 (ADH1) [1][2] - Dr. Rachel Gafni will discuss the pathophysiology of ADH1, the unmet medical needs, and the rationale for evaluating encaleret as a treatment [2] - The ongoing CALIBRATE study is expected to provide topline results in fall 2025 [2] Company Overview - BridgeBio Pharma is a biopharmaceutical company established to develop transformative medicines for genetic diseases, with a pipeline that includes early science to advanced clinical trials [4] - Founded in 2015, the company aims to leverage advances in genetic medicine to expedite patient treatment [4] Webinar Access - The investor webinar can be accessed via the "Events & Presentations" section on BridgeBio's website, with a replay available for 30 days post-event [3]

Core Insights - BridgeBio Pharma reported strong commercial progress with 3,751 unique patient prescriptions for Attruby as of August 1, 2025, indicating robust month-over-month growth in treatment-naïve patients [1][3] - The company achieved total second-quarter revenue of $110.6 million, driven by $71.5 million in U.S. Attruby net product revenue, $1.6 million in royalty revenue, and $37.5 million in license and services revenue [1][12] - Attruby's clinical profile was reinforced by new analyses from the ATTRibute-CM study, showing significant benefits for patients, including a 59% relative risk reduction in mortality and a 43% reduction in annual frequency of cardiovascular hospitalization due to atrial fibrillation [1][8] Commercial Progress - The launch of Attruby has accelerated, with nearly double the product revenue this quarter, attributed to growing adoption among healthcare providers [4] - The company ended the quarter with $756.9 million in cash and marketable securities, positioning it well for ongoing commercial activities and upcoming clinical trials [2][9] Pipeline Overview - Key upcoming milestones include topline results from the CALIBRATE study for encaleret in ADH1 expected in fall 2025, and from the PROPEL 3 study for infigratinib in achondroplasia expected in early 2026 [2][11] - The FORTIFY Phase 3 study of BBP-418 for LGMD2I/R9 has completed enrollment, with topline results anticipated in fall 2025 [1][6] Financial Performance - Total revenues for the three months ended June 30, 2025, were $110.6 million, a significant increase from $2.2 million in the same period last year, primarily due to the success of Attruby [12][13] - Operating costs for the quarter were $244.8 million, up from $177.7 million year-over-year, largely driven by increased selling, general, and administrative expenses related to the commercial launch of Attruby [14][15] Key Program Updates - Attruby is positioned as a near-complete transthyretin stabilizer for treating transthyretin amyloid cardiomyopathy (ATTR-CM), with ongoing studies to further validate its efficacy [7][31] - The company is also advancing its pipeline with BBP-418 and encaleret, aiming to address significant unmet needs in genetic diseases [9][11]

Pipeline and Approvals - Attruby (acoramidis) is now FDA approved in the US for Transthyretin Amyloidosis (ATTR-CM)[8, 40, 42] - Beyonttra (acoramidis) is approved in the EU, Japan, and UK[11, 32] - Three Phase 3 trials are fully enrolled: BBP-418 for Limb-Girdle Muscular Dystrophy 2I/R9 (112 patients), encaleret for Autosomal Dominant Hypocalcemia Type 1 (71 patients), and infigratinib for Achondroplasia (114 participants)[12] Attruby (acoramidis) Clinical and Commercial Performance - Attruby demonstrated a 42% reduction in the composite of all-cause mortality and recurrent cardiovascular-related hospitalization events at Month 30[44] - Attruby showed a 50% reduction in the cumulative frequency of cardiovascular-related hospitalization events at Month 30[44] - In Q1 2025, Attruby generated $36.7 million in total U S revenue[51] - Attruby has achieved 77% Medicare lives in equal formulary position to tafamidis[51] Market and Financial Outlook - The global annual ATTR market is projected to reach $15-$20 billion at its peak[30, 66] - BridgeBio envisions a vision for 2030 with >$8 billion in revenue[35] - The company estimates the market opportunity for Infigratinib in Achondroplasia and Hypochondroplasia to be $2B+ each[30] - The company estimates the market opportunity for BBP-418 in Limb-Girdle Muscular Dystrophy Type 2I/R9 (LGMD2I/R9) to be $1B+[30, 146] - The company estimates the market opportunity for Encaleret in Autosomal Dominant Hypocalcemia Type 1 (ADH1) to be $1B+[30, 121]

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]