Chief Commercial Officer Matt Houghton said Attruby’s growth has been strongest in first-line patients and attributed momentum to the “exceptional data” for the therapy and the company’s field execution. He emphasized that the company has historically provided a quarterly “new patient start” figure, but said BridgeBio will stop reporting that metric going forward because competitors do not disclose comparable data and continued disclosure could create a competitive disadvantage.BridgeBio reiterated that Att ...

BridgeBio (NasdaqGS:BBIO) Q4 2025 Earnings call February 24, 2026 04:30 PM ET Company ParticipantsAdi Jayaraman - Senior Managing DirectorAndrew Tsai - Managing DirectorChinmay Shukla - SVP of Strategic FinanceJustin To - CEO of Skeletal DysplasiasMatt Outten - Chief Commercial OfficerNeil Kumar - CEOTom Trimarchi - President and CFOConference Call ParticipantsBiren Amin - Managing Director and Investment Analyst in Life SciencesEliana Merle - Senior Biotech Equity Research AnalystMani Foroohar - Senior Man ...

BridgeBio (NasdaqGS:BBIO) Q4 2025 Earnings call February 24, 2026 04:30 PM ET Company ParticipantsAdi Jayaraman - Senior Managing DirectorAndrew Tsai - Managing DirectorChinmay Shukla - SVP of Strategic FinanceJustin To - CEO of Skeletal DysplasiasMatthew Outten - Chief Commercial OfficerNeil Kumar - CEOTom Trimarchi - President and CFOConference Call ParticipantsBiren Amin - Managing Director and Investment Analyst in Life SciencesEliana Merle - Senior Biotech Equity Research AnalystMani Foroohar - Senior ...

BridgeBio (NasdaqGS:BBIO) Q4 2025 Earnings call February 24, 2026 04:30 PM ET Speaker9Good afternoon. I'll be your conference operator today. All lines have been placed on mute to prevent any background noise. After the company's remarks, there will be a question and answer session. If you would like to ask a question, press star followed by 1 on your telephone keypad. If you'd like to withdraw your question, press the pound key. Thank you. Before we begin, I'd like to remind everyone that today's call may ...

Core Insights - BridgeBio Pharma reported preliminary unaudited Q4 and Full Year 2025 net product revenue of $146.0 million and $362.4 million respectively, indicating strong commercial performance for its product Attruby (acoramidis) [1] - Attruby is becoming the preferred therapy for newly diagnosed ATTR-CM patients, with 6,629 unique patient prescriptions written by 1,632 prescribers as of December 31, 2025, driven by its differentiated clinical data and increasing real-world confidence [1] - The company announced a new TTR amyloid depleter antibody program aimed at exploring the potential for ATTR-CM disease reversal, with clinical advancement expected between 2027 and 2028 [1] - Interim analysis from the FORTIFY Phase 3 study of BBP-418 in LGMD2I/R9 showed significant benefits, leading the FDA to recommend a traditional full approval pathway, with an NDA submission planned for the first half of 2026 [1] - A rapid increase in the diagnosis of ADH1 has been noted, with over 1,700 unique patients identified since October 2023, and an NDA submission for encaleret based on CALIBRATE trial results is anticipated in the first half of 2026 [1] - The initiation of the RECLAIM-HP Phase 3 trial for encaleret in chronic hypoparathyroidism is scheduled for summer 2026 following a successful End of Phase 2 interaction with the FDA [1] - The PROPEL 3 Phase 3 study of infigratinib for children with achondroplasia has achieved LPLV, with topline results expected by the end of Q1 2026 [1] - As of December 31, 2025, the company had approximately $587.5 million in cash, cash equivalents, and marketable securities, positioning it well to support the acceleration of Attruby and potentially launch three additional medicines globally [1] Company Overview - BridgeBio Pharma is a biopharmaceutical company focused on genetic diseases, founded in 2015, with a commitment to delivering transformative medicines quickly and effectively [2][7] - The company operates on a decentralized model, aiming to double the number of patients served by the end of 2026 [2]

Core Insights - BridgeBio Pharma reported preliminary unaudited Q4 and Full Year 2025 net product revenue of $146.0 million and $362.4 million, respectively, indicating strong commercial performance for its product Attruby (acoramidis) [1] - Attruby is becoming the preferred therapy for newly diagnosed ATTR-CM patients, with 6,629 unique patient prescriptions written by 1,632 prescribers as of December 31, 2025, driven by its differentiated clinical data [1] - The company announced a new TTR amyloid depleter antibody program aimed at exploring the potential for ATTR-CM disease reversal, with clinical advancement expected between 2027 and 2028 [1] - The interim analysis from the FORTIFY Phase 3 study of BBP-418 in LGMD2I/R9 showed a statistically significant 2.6 point benefit on NSAD relative to placebo at 12 months, leading the FDA to recommend a traditional full approval pathway [1] - A rapid increase in the diagnosis of ADH1 has been observed, with over 1,700 unique patients identified since October 2023, prompting the company to plan an NDA submission based on CALIBRATE trial results in the first half of 2026 [1] - The initiation of the RECLAIM-HP Phase 3 trial of encaleret in chronic hypoparathyroidism is scheduled for summer 2026 following a completed End of Phase 2 interaction with the FDA [1] - The company achieved LPLV for PROPEL 3, with topline results expected by the end of Q1 2026, and LPI for the Phase 2 portion of ACCEL 2/3 [1] - As of December 31, 2025, the company had approximately $587.5 million in cash, cash equivalents, and marketable securities, positioning it well to support the acceleration of Attruby and potentially launch three additional medicines globally [1] Company Overview - BridgeBio Pharma is a biopharmaceutical company focused on discovering, creating, testing, and delivering transformative medicines for genetic diseases, founded in 2015 [6] - The company emphasizes a decentralized model to drive impact across various communities, aiming to double the number of patients served by the end of 2026 [2]

Core Insights - BridgeBio Pharma reported a total revenue of $120.7 million for Q3 2025, driven primarily by $108.1 million in U.S. Attruby net product revenue, alongside $4.3 million from royalty revenue and $8.3 million in license and services revenue [1][3][10] - The company has seen significant commercial progress, with 5,259 unique patient prescriptions written by 1,355 unique prescribers as of October 25, 2025, indicating strong adoption of Attruby since its FDA approval in November 2024 [1][2][4] - BridgeBio plans to file New Drug Applications (NDAs) for BBP-418 and encaleret in the first half of 2026, aiming for full approval of these therapies [1][5][8] Commercial Performance - Attruby's launch has been characterized by strong physician adoption and continued growth across all market segments, reflecting its differentiated clinical profile [4][6] - The company reported a significant increase in total revenues, with a $118 million rise compared to the same period last year, primarily due to the commercial success of Attruby [10][11] Pipeline Developments - Positive interim analysis results from the FORTIFY Phase 3 study of BBP-418 showed a 1.8x increase in glycosylated αDG from baseline at 3 months, with sustained improvements at 12 months [1][8] - The CALIBRATE Phase 3 study of encaleret for ADH1 met its primary endpoint, with 76% of participants achieving target calcium levels at Week 24 [1][8] - The PROPEL 3 study of infigratinib for achondroplasia is fully enrolled, with topline results expected in early 2026 [1][8] Financial Overview - As of September 30, 2025, the company had $645.9 million in cash, cash equivalents, and marketable securities, positioning it well to support the commercialization of Attruby and advance its late-stage pipeline [1][9] - Operating costs for Q3 2025 were $265.9 million, reflecting increased investments in support of Attruby's commercial launch [14][15] Key Metrics - The net loss attributable to common stockholders for Q3 2025 was $182.7 million, compared to $162.0 million for the same period in the prior year, with a net loss per share of $0.95 [22][23] - Total revenues for the nine months ended September 30, 2025, were $347.9 million, up from $216.0 million in the prior year [11][12]

Summary of BridgeBio Pharma's Conference Call on ADH1 Calibrate Phase 3 Results Company and Industry Context - **Company**: BridgeBio Pharma - **Industry**: Biotechnology, specifically focusing on rare genetic conditions and therapies Key Points and Arguments 1. **Positive Phase 3 Data**: The Calibrate clinical trial for autosomal dominant hypocalcemia type 1 (ADH1) showed positive results, marking a significant advancement for patients suffering from this condition [2][8][22] 2. **Therapeutic Impact**: Encaleret, the investigational drug, demonstrated the ability to normalize calcium and parathyroid hormone (PTH) levels in a majority of patients, addressing the root cause of ADH1 [5][11][22] 3. **Study Results**: - 76% of participants achieved target serum and urine calcium levels within 24 weeks of treatment with encaleret [8][17] - 91% of participants showed a positive response in PTH levels [18] - Encaleret was well tolerated, with no discontinuations due to adverse effects [9][21] 4. **Prevalence of ADH1**: The estimated prevalence of ADH1 is approximately 1 in 25,000, translating to about 12,000 individuals in the U.S. [9][10] 5. **Mechanism of Action**: Encaleret acts as a calcilytic, targeting the calcium-sensing receptor (CASR) to restore mineral homeostasis, which is disrupted in ADH1 patients [10][11] 6. **Future Studies**: Plans to initiate a phase 2/3 study in pediatric patients and a phase 3 study in chronic hypoparathyroidism are underway [24][26] Additional Important Information 1. **Commercial Strategy**: BridgeBio Pharma is preparing for a potential blockbuster launch of encaleret, leveraging its existing commercial infrastructure from previous product launches [26][29] 2. **Market Dynamics**: The ADH1 market is underrecognized, presenting a significant opportunity for diagnosis and treatment expansion [27][66] 3. **Regulatory Engagement**: The company plans to engage with the FDA for a New Drug Application (NDA) submission in the first half of 2026 [24] 4. **Patient Identification**: Increased awareness and new ICD-10 codes are expected to facilitate the identification of ADH1 patients, enhancing market access [45][66] 5. **Safety Profile**: The safety profile of encaleret appears favorable, with manageable adverse events primarily related to the drug's mechanism of action [21][94] This summary encapsulates the critical insights from the conference call, highlighting the advancements in treatment for ADH1 and the strategic direction of BridgeBio Pharma.

Core Insights - The CALIBRATE study of encaleret for patients with ADH1 met all pre-specified primary and key secondary efficacy endpoints [1] - Encaleret demonstrated significant efficacy in achieving target serum and urine calcium levels compared to conventional therapy [2] - The drug was well-tolerated with no discontinuations related to the study drug [1] Efficacy Results - 76% of participants treated with encaleret achieved both serum and urine calcium within target ranges at Week 24, compared to 4% on conventional therapy at Week 4 (p<0.0001) [1][2] - In a key secondary analysis, 91% of encaleret-treated participants had intact PTH above the lower limit of the reference range at Week 24, compared to 7% on conventional therapy at Week 4 (p<0.0001) [1] - By Day 3 after randomization, 71% of encaleret participants had an albumin-corrected serum calcium within the reference range [4] Safety and Tolerability - Encaleret was well-tolerated, with safety findings consistent with known ADH1 biology [12] - 65 of 67 randomized participants (97%) chose to continue in the long-term extension of the study [5] Future Plans - The company plans to submit a New Drug Application (NDA) to the FDA in the first half of 2026 [1][6] - Registrational studies of encaleret in chronic hypoparathyroidism and pediatric ADH1 are planned for 2026 [1][6] Study Design - The CALIBRATE study enrolled 70 adults with ADH1, randomizing 67 participants in a 2:1 ratio (encaleret: standard of care) [4] - The primary endpoint was defined as the proportion of participants achieving target serum and urine calcium levels [2]

Core Insights - The presentation focuses on encaleret, a small molecule being developed for autosomal dominant hypocalcemia type 1 (ADH1) [2][3] - The webinar includes insights from key figures in the field, including Dr. Rachel Gafni and Dr. Scott Adler, who will discuss the clinical development program for encaleret [3] Market Opportunity - The company aims to highlight the market potential for ADH1 and the patient experience associated with the condition [4]