Financial Data and Key Metrics Changes - Total revenues for Q1 2025 were $116.6 million, consisting of $36.7 million in attributed net product revenue and $79.9 million in license and services revenue [34] - Attributed net product revenue of $36.7 million was driven by strong demand across all major prescribers and patient segments [34] - Total operating expenses for Q1 2025 were $218.4 million, compared to $210.2 million in the same period last year, reflecting continued investment in the Atruvio brand and advancing late-stage pipeline [35] Business Line Data and Key Metrics Changes - The launch of Atruvio generated $36.7 million in revenue, indicating strong clinician and patient resonance with its clinical efficacy and safety [7][34] - The company reported 2,072 unique patients receiving prescriptions for Atruvio through April 25, with 756 unique healthcare providers writing at least one prescription [25] - The company expects to achieve peak year sales of $4.3 billion, representing about 30% of a $15 billion marketplace for Atruvio [18] Market Data and Key Metrics Changes - The market for ATTR Centimeters is estimated to have 250,000 to 300,000 patients in the U.S., with only about 50,000 diagnosed, indicating significant growth potential [44] - The company is seeing early uptake across all major prescriber and patient segments, including large academic centers and community cardiologists [25][26] Company Strategy and Development Direction - The company aims to maximize positive change in quality-adjusted life years for patients by developing meaningful medicines quickly, focusing on high-probability technical success programs [11][16] - BridgeBio is committed to a transparent commercial model that prioritizes patient access and support, differentiating itself from competitors [30] - The company plans to launch three additional commercial products in 2026 and 2027, expanding its portfolio [30] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing demand for Atruvio, attributing it to differentiated clinical efficacy and strong access programs [44][46] - The company anticipates modest growth in quarterly operating expenses for the remainder of the year, offset by Atruvio sales [35] - Management highlighted the importance of physician education and the growing market for ATTR therapies as key drivers for future growth [44][45] Other Important Information - The company received a $75 million regulatory milestone related to BEYONDRA's EU approval and expects to recognize a $30 million milestone in Q2 for BEYONDRA's approval in Japan [34] - The company ended the quarter with $540.6 million in cash and cash equivalents, excluding anticipated regulatory milestone payments [37] Q&A Session Summary Question: Can you provide granularity on the tailwind and what is working well? - Management noted that the demand is driven by differentiated clinical efficacy, market growth, and effective access programs [44][46] Question: Can you quantify the paid conversion rate and stocking in the quarter? - Management indicated that conversion rates are consistent or better than historical launches, with minor inventory impact on total sales [53][57] Question: What is resonating with healthcare professionals regarding the Atruvio launch? - Positive feedback has been received regarding the drug's rapid efficacy and strong patient support programs [84][86] Question: How do you expect new patient starts to evolve going forward? - Management expects continued growth in new patient diagnoses, driven by increased awareness and education among healthcare professionals [99][100] Question: What are the biggest hurdles for adoption? - The main hurdles include ensuring physicians are aware of the drug's benefits and navigating the competitive landscape as new entrants emerge [84][86]

Financial Performance - Revenues for Q1 2025 were $116.6 million, a decrease of $94.5 million compared to $211.1 million in Q1 2024, primarily due to a $131.2 million drop in license and services revenue[11] - The net loss attributable to common stockholders for Q1 2025 was $167.4 million, compared to a net loss of $35.2 million in Q1 2024, resulting in a net loss per share of $0.88[20] - Total revenues for the three months ended March 31, 2025, were $116.633 million, a decrease from $211.120 million in the same period of 2024, representing a decline of approximately 44.7%[23] - The net loss for the first quarter of 2025 was $169.608 million, compared to a net loss of $36.160 million in the first quarter of 2024, indicating a significant increase in losses[23] - Operating costs for Q1 2025 were $221.0 million, an increase from $210.8 million in the same period last year, driven by a $40.5 million rise in selling, general and administrative expenses[15] - Total other expense for Q1 2025 was $65.2 million, an increase of $28.7 million compared to $36.5 million in Q1 2024, primarily due to higher interest expenses[18] - The total operating costs and expenses for the first quarter of 2025 were $221.005 million, compared to $210.777 million in the same period of 2024, an increase of approximately 4.9%[23] - The company incurred interest expense of $42.141 million in the first quarter of 2025, compared to $23.471 million in the same period of 2024, indicating an increase of approximately 79.3%[23] Cash and Assets - The company ended Q1 2025 with $540.6 million in cash and cash equivalents, down from $681.1 million at the end of 2024, reflecting a net cash used in operating activities of $199.2 million[10] - Cash and cash equivalents as of March 31, 2025, were $540.599 million, down from $681.101 million at the end of 2024, a decrease of approximately 20.7%[26] - The total assets as of March 31, 2025, were $881.638 million, a decrease from $919.338 million at the end of 2024, representing a decline of about 4.1%[26] - The company reported a net cash used in operating activities of $199.235 million for the first quarter of 2025, compared to $219.537 million in the same period of 2024, showing a decrease of approximately 9.2%[29] Clinical Trials and Product Development - The Phase 3 trial for BBP-418 in LGMD2I/R9 is fully enrolled with 112 participants, and the interim analysis topline readout is expected in the second half of 2025[8] - The Phase 3 trial of encaleret for ADH1 is also fully enrolled with 71 participants, with topline results anticipated in the second half of 2025[8] - BridgeBio expects encaleret to potentially become the first approved therapy for the treatment of ADH1[35] - The company anticipates BBP-812 could be the first therapeutic option for children born with Canavan disease[35] - BridgeBio plans to advance encaleret to a chronic hypoparathyroidism registrational study[35] - The expected completion of enrollment for BBP-812 in the CANaspire pivotal Phase 1/2 study is a key milestone[35] - BridgeBio is conducting multiple clinical trials, including the ACT-EARLY Phase 3 study[35] Regulatory and Market Considerations - Acoramidis was approved in the U.S., EU, UK, and Japan, with a significant 59% risk reduction for all-cause mortality or first cardiovascular-related hospitalization reported in a study subgroup[6] - The company expects to receive $105 million in regulatory milestone payments in Q2 for ex-U.S. approvals of BEYONTTRA®[10] - The company acknowledges potential risks related to regulatory approvals and market conditions[35] - BridgeBio's forward-looking statements are subject to risks and uncertainties that could lead to actual results differing materially[35] Strategic Focus and Funding - The company is focused on the commercial success of Attruby/BEYONTTRA[35] - BridgeBio is actively seeking additional funding through less dilutive sources than equity financings[35] - The company is monitoring macroeconomic factors, including inflation and geopolitical events, that may impact operations[35]

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]

Core Insights - The UK has granted marketing authorization for acoramidis, branded as BEYONTTRA, for treating wild-type or variant transthyretin amyloidosis in adult patients with cardiomyopathy (ATTR-CM) [1][2] - Acoramidis is the first and only approved treatment for ATTR-CM in the U.S., EU, UK, and Japan, with a label specifying near-complete stabilization (≥90%) of transthyretin (TTR) [1][3] - The approval is based on positive results from the Phase 3 ATTRibute-CM study, which demonstrated significant cardiovascular benefits [2][3] Summary by Category Product Approval - The Medicines and Healthcare products Regulatory Agency in the UK has approved acoramidis for ATTR-CM treatment [1][2] - Acoramidis has previously received approvals in the U.S. as Attruby™ and in the EU and Japan as BEYONTTRA [3] Clinical Study Results - The ATTRibute-CM study involved 632 participants and showed a 42% reduction in composite all-cause mortality and recurrent cardiovascular-related hospitalization events at Month 30 compared to placebo [1][2] - A 50% reduction in the cumulative frequency of cardiovascular-related hospitalization events was also observed at Month 30 [1] Market and Financial Aspects - BridgeBio will receive royalties in a tiered structure starting in the low-thirties percent on sales of BEYONTTRA in the UK [1][4][5] - Bayer is responsible for all commercial activities related to acoramidis in the UK [1][3]

Core Viewpoint - Purcell & Lefkowitz LLP is investigating BridgeBio Pharma, Inc. to determine if the company's directors breached their fiduciary duties related to recent corporate actions [1]. Group 1 - The investigation is on behalf of BridgeBio Pharma's shareholders [1]. - The law firm specializes in representing shareholders affected by securities fraud and breaches of fiduciary duty [3]. - Shareholders seeking more information can contact the firm for free [2].

PALO ALTO, Calif., April 22, 2025 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (NASDAQ:BBIO) ("BridgeBio" or the "Company"), a new type of biopharmaceutical company focused on genetic diseases, today announced that it will release its first quarter financial results and program updates after the market closes on Tuesday, April 29, 2025. BridgeBio will host a conference call to discuss the financial results and program updates at 4:30 pm ET the same day. To access the live webcast of BridgeBio's presentation, ...

PALO ALTO, Calif., March 31, 2025 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (NASDAQ:BBIO) ("BridgeBio" or the "Company"), a new type of biopharmaceutical company focused on genetic diseases, today presented results showing statistically significant improvements in clinical outcomes as compared to placebo for time to all-cause mortality (ACM) or first cardiovascular-related hospitalization (CVH) in both variant (ATTRv) and wild-type (ATTRwt) transthyretin amyloid cardiomyopathy (ATTR-CM) patients from a pre ...

Core Viewpoint - BridgeBio Pharma has received approval from the Japanese Ministry of Health for acoramidis, branded as Beyonttra, to treat adults with transthyretin-mediated amyloid cardiomyopathy (ATTR-CM), marking a significant advancement in treatment options for this progressive and fatal disease [1][2]. Company Overview - BridgeBio Pharma, Inc. is a biopharmaceutical company focused on developing treatments for genetic diseases, founded in 2015. The company aims to deliver transformative medicines through a pipeline that includes early science to advanced clinical trials [9]. Product Details - Acoramidis is a selective small molecule, orally administered, and is a near-complete (≥90%) stabilizer of transthyretin (TTR). It has shown potential in reducing all-cause and cardiovascular mortality risks [1][6]. - The drug was well-tolerated in clinical trials, with a reported 0% mortality during a 30-month treatment period in the Japanese Phase 3 study [3][8]. Clinical Trial Results - The approval in Japan was based on positive outcomes from a Phase 3 open-label study and the global ATTRibute-CM Phase 3 trial. Key findings include: - Early separation in time to first event (all-cause mortality or cardiovascular-related hospitalization) at 3 months compared to placebo [3][8]. - A 42% reduction in composite all-cause mortality and recurrent cardiovascular hospitalization events at Month 30 relative to placebo [3][8]. - A 50% reduction in cumulative frequency of cardiovascular hospitalization events at Month 30 compared to placebo [3][8]. Commercialization and Financials - Alexion, AstraZeneca Rare Disease holds an exclusive license to develop and commercialize acoramidis in Japan. BridgeBio will receive a $30 million milestone payment upon approval and low double-digit royalties on sales [4][8].

Core Insights - BridgeBio Pharma announced the presentation of cardiovascular outcomes data from its Phase 3 study of acoramidis in patients with ATTR-CM at the ACC Annual Scientific Sessions & Expo in March 2025 [1] Group 1: Presentation Details - Acoramidis improves serum TTR levels in patients with wild-type or variant transthyretin amyloid cardiomyopathy [2] - Acoramidis improves NYHA class at month 30 versus placebo in patients with ATTR-CM [2] - Addition of concomitant tafamidis did not further increase serum TTR levels in participants treated with acoramidis [3] - Efficacy results of acoramidis in ATTR-CM were robust according to pre-specified NT-proBNP sensitivity analyses [3] - Acoramidis-mediated early increase in serum transthyretin level reduces cardiovascular-related hospitalizations and mortality [3] Group 2: Moderated Posters - Primary endpoint efficacy results in the ATTRibute-CM study addressed tafamidis use [4] - Geographic healthcare disparities and diagnostic trends among patients with transthyretin amyloid cardiomyopathy [4] Group 3: Product Information - Attruby (acoramidis) is the first near-complete stabilizer of TTR approved in the U.S. for treating ATTR-CM in adults [5] - Attruby aims to reduce cardiovascular death and related hospitalizations and was generally well-tolerated with mild side effects [5] Group 4: Company Overview - BridgeBio Pharma focuses on discovering, creating, testing, and delivering transformative medicines for genetic diseases [6] - The company was founded in 2015 and has a pipeline ranging from early science to advanced clinical trials [6]

Core Insights - BridgeBio Pharma, Inc. has appointed Thomas Trimarchi, Ph.D. as President and Chief Financial Officer, who will continue to oversee FP&A and accounting operations [1] - Brian Stephenson, Ph.D. is departing from the company for personal reasons but will remain as a consultant [2] - Dr. Stephenson expressed pride in his contributions to the company and its innovative financial model aimed at serving patients with genetic diseases [3] Company Overview - BridgeBio Pharma, Inc. is a biopharmaceutical company focused on discovering, creating, testing, and delivering transformative medicines for genetic diseases [4] - The company was founded in 2015 and has a pipeline that includes programs from early science to advanced clinical trials [4] - The team is dedicated to applying advances in genetic medicine to expedite patient care [4]