Group 1 - The article emphasizes the importance of enabling Javascript and cookies in browsers to prevent access issues [1] - It mentions that users with ad-blockers may face restrictions when trying to access the content [1]

Financial Data and Key Metrics Changes - Total revenues for Q3 2025 were $120.7 million, a significant increase from $2.7 million in the same period last year, primarily driven by $108.1 million in net product revenue from Atrobi [25][26]. - Total operating expenses increased to $259.3 million from $193.9 million year-over-year, with a notable rise in SG&A expenses by $68.8 million [26][27]. - The company ended Q3 with a strong cash position of $645.9 million, providing a solid cash runway for future operations [27]. Business Line Data and Key Metrics Changes - Atrobi generated $108.1 million in net product sales, with 5,259 unique patient prescriptions delivered to 1,355 unique healthcare providers [11][25]. - The company reported strong growth in the ATTR-CM market, with an increase in prescribing from both returning and new physicians [18][21]. Market Data and Key Metrics Changes - The ATTR-CM market continues to expand, with no signs of slowing down, contributing to a sustained growth runway for Atrobi [21]. - The company is seeing increased diagnosis rates for ATTR-CM, with expectations to reach closer to 250,000 diagnosed patients in the U.S. [39]. Company Strategy and Development Direction - The company aims for a market share of 30+% by volume in the coming years, focusing on the continued success of Atrobi and the upcoming launches of Encalirate and BBP-418 [6][11]. - The company is actively building infrastructure for global commercialization to ensure access to its therapies worldwide [24]. Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing success of Atrobi and the potential for strong market share growth, supported by positive clinical data from recent trials [6][11]. - The company is optimistic about the upcoming readouts for Infogratinib and the continued expansion of its pipeline [22][24]. Other Important Information - The company has a robust late-stage pipeline, with significant progress in R&D, including two recent positive phase 3 trial results [4][6]. - The company is focused on leveraging real-world evidence to support its market position and drive adoption of its therapies [16][78]. Q&A Session Summary Question: What is the percentage of new patient share for Atrobi? - Management estimates that the naive share is well in the 20s, with double-digit growth in overall prescriptions quarter-on-quarter [30][31]. Question: Can you elaborate on ATTR-CM diagnosis rates? - There has been robust growth in diagnosis rates, with ongoing education and excitement in the medical community about ATTR cardiomyopathy [39]. Question: Thoughts on Pfizer's 28-day free trial program? - Management views it positively as it encourages competition and emphasizes the importance of access for patients [44][46]. Question: How does the ex-US opportunity compare to the US market? - The ex-US opportunity is promising, with Bayer successfully commercializing in Europe, although pricing dynamics differ [50][52]. Question: Will there be a head-to-head study against Tafamidis? - Management believes that real-world evidence will be more impactful than a costly head-to-head study, as they already demonstrate superior efficacy [72][78]. Question: What differentiates Infogratinib in achondroplasia? - Infogratinib is expected to be more efficacious, safer, and more convenient due to its oral administration, addressing unmet needs in the market [83][86].

Financial Data and Key Metrics Changes - Total revenues for Q3 2025 were $120.7 million, consisting of $108.1 million from Attruby net product revenue, $4.3 million in royalty revenue, and $8.3 million in license and services revenue, compared to $2.7 million in the same period last year, indicating a significant increase in total revenues driven primarily by Attruby sales [25][26][27] - Operating expenses for Q3 2025 were $259.3 million, up from $193.9 million in the same period last year, with a notable increase in SG&A expenses [26][27] Business Line Data and Key Metrics Changes - Attruby generated $108.1 million in net product sales in Q3 2025, with 5,259 unique patient prescriptions delivered to 1,355 unique healthcare providers, reflecting strong commercial execution [11][25] - The company aims for a market share of 30-35% by volume in the ATTR-CM market, with continued momentum in both scientific and commercial aspects of the Attruby franchise [6][11] Market Data and Key Metrics Changes - The ATTR-CM market continues to expand, with growth coming from all segments, and an increase in prescribing from both returning and new physicians [18][20] - The company has seen a steady rise in first-time prescribers adopting Attruby, indicating growing prescriber confidence and sustained demand [20][21] Company Strategy and Development Direction - The company is focused on launching new products from its late-stage pipeline, including Encalirate and BBP-418, which have shown promising phase III results [4][22] - The strategy includes leveraging the experience gained from the Attruby launch to inform future product launches and expanding disease state education initiatives [22][23] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving a market share of over 30% for Attruby, supported by strong clinical data and ongoing market expansion [6][11] - The company anticipates continued growth in diagnosis rates for ATTR-CM, with expectations to reach approximately 250,000 diagnosed patients in the U.S. [39] Other Important Information - The company ended Q3 2025 with a strong cash position of $645.9 million, providing significant cash runway for future investments [27] - The company is actively building infrastructure for global commercialization to ensure access to its therapies worldwide [24] Q&A Session Summary Question: What is the percentage of new patient share for Attruby? - Management estimates that the naive share is well in the 20s, with double-digit growth in overall prescriptions quarter-on-quarter [30][31] Question: Can you elaborate on ATTR-CM diagnosis rates? - There has been robust growth in diagnosis rates, with ongoing excitement and education in the field, leading to increased identification of new patients [39] Question: Thoughts on Pfizer's 28-day free trial program? - Management views it positively as it encourages competition and emphasizes the importance of access programs [44][46] Question: How does the ex-US opportunity compare to the US? - The ex-US opportunity is promising, with Bayer successfully commercializing in Europe, although pricing dynamics differ [50][52] Question: Discussions with payers regarding formulary positioning of Attruby? - Management has not had discussions about formulary positioning with payers but remains focused on ensuring Attruby's availability [54][56] Question: What is driving the growth in unique prescribers and prescriptions per prescriber? - Growth is driven by both increased penetration within existing accounts and expansion into new centers, with a focus on educating physicians [58][60] Question: What are the differentiating elements for Infigratinib in achondroplasia? - Infigratinib is expected to be more efficacious, safer, and more convenient due to its oral route of administration [84][86]

Financial Data and Key Metrics Changes - Total revenues for Q3 2025 were $120.7 million, a significant increase from $2.7 million in the same period last year, primarily driven by $108.1 million in net product revenue from Atrobi [26][27] - Total operating expenses increased to $259.3 million from $193.9 million year-over-year, with a notable rise in SG&A expenses by $68.8 million [26][27] - The company ended the quarter with a strong cash position of $645.9 million, providing a solid cash runway for future operations [27] Business Line Data and Key Metrics Changes - Atrobi generated $108.1 million in net product sales, with 5,259 unique patient prescriptions delivered to 1,355 unique healthcare providers [11][26] - The company aims for a market share of 30% to 35% by volume in the ATTR-CM market, with continued growth expected [11][19] Market Data and Key Metrics Changes - The ATTR-CM market is expanding, with growth coming from all segments, and an increase in prescribing from both returning and new physicians [19][21] - The company has seen a steady rise in first-time prescribers adopting Atrobi, indicating growing confidence among healthcare providers [19][21] Company Strategy and Development Direction - The company is focused on expanding its late-stage pipeline, with recent positive phase 3 readouts for BBP-418 and Encalirate, which are expected to redefine care for patients [23][25] - The strategy includes leveraging the success of Atrobi to inform future product launches and expanding disease state education initiatives [24][25] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing success of Atrobi and the potential for significant market share growth, supported by strong clinical data and a competitive pricing strategy [11][19] - The company anticipates continued growth in diagnosis rates for ATTR-CM, which will further expand the patient population eligible for Atrobi [36] Other Important Information - The company is actively building infrastructure for global commercialization to ensure access to its therapies worldwide [25] - Management highlighted the importance of real-world evidence in demonstrating the efficacy of Atrobi compared to competitors [70] Q&A Session Summary Question: What is the percentage of new patient share for Atrobi? - Management estimates that the naive share is now well in the 20s, with double-digit growth in overall prescriptions quarter-on-quarter [31] Question: Can you elaborate on ATTR-CM diagnosis rates? - There has been robust growth in diagnosis rates, with ongoing excitement and education in the field, leading to an expected increase in diagnosed patients [36] Question: Thoughts on Pfizer's 28-day free trial program? - Management views it positively as it encourages competition and emphasizes the importance of access for patients [41][42] Question: How do you see the ex-US opportunity relative to the US? - The ex-US opportunity is promising, with Bayer successfully commercializing in Europe, and management expects similar sales ratios between Europe and the US [48] Question: Have you discussed formulary positioning of Atrobi with payers? - Management has focused on ensuring Atrobi is on an equal playing field with competitors and has not yet had discussions regarding formulary positioning [49][50] Question: What is driving the momentum in unique prescribers and prescriptions per prescriber? - The momentum is driven by both greater penetration within existing accounts and expansion into new centers, with a focus on educating physicians [52] Question: What differentiates Infogratinib in achondroplasia? - Infogratinib is expected to be more efficacious, safer, and more convenient due to its oral administration, addressing unmet needs in the market [73][75] Question: What are the key assumptions for the $2 billion opportunity in achondroplasia and hypochondroplasia? - The estimates are based on capturing share from competitors and growing the market, addressing substantial unmet needs not covered by existing therapies [78]

Financial Performance - BridgeBio generated net product revenue of $216.4 million during the nine months ended September 30, 2025[303]. - The company incurred net losses of $538.3 million and $276.0 million for the nine months ended September 30, 2025 and 2024, respectively[306]. - Total revenues, net for the three months ended September 30, 2025, increased by $118.0 million to $120.7 million compared to the same period in 2024, driven by a $108.1 million increase in net product revenue[318]. - Net product revenue for the three and nine months ended September 30, 2025, was $108.1 million and $216.4 million, respectively, generated from the commercial sale of Attruby in the U.S. following FDA approval in November 2024[319]. - The net loss attributable to common stockholders for the three months ended September 30, 2025, was $182.7 million, compared to a net loss of $162.0 million in the same period of 2024[316]. - For the nine months ended September 30, 2025, the company incurred a net loss of $538.3 million, compared to $276.0 million for the same period in 2024, representing a 95.0% increase in losses year-over-year[351]. Revenue Sources - The company anticipates future revenue to primarily be generated from recurring net product revenue following the commercialization of Attruby and significant future royalty revenue from Beyonttra sales[323]. - License and services revenue for the three months ended September 30, 2025, increased by $5.6 million, while for the nine months, it decreased by $90.6 million due to prior year recognition of $205.3 million in upfront license fees[321]. - Royalty revenue for the three and nine months ended September 30, 2025, was $4.3 million and $6.1 million, respectively, related to sales of Beyonttra in the EU and Japan following regulatory approvals[322]. Expenses and Losses - The company expects to continue incurring operating and net losses for at least the next several years[306]. - Selling, general and administrative expenses increased by $68.8 million (100.0%) for the three months ended September 30, 2025, and by $179.0 million (91.9%) for the nine months ended September 30, 2025, compared to the same periods in 2024[333][335]. - The increase in selling, general and administrative expenses for the three months was primarily driven by a $43.4 million increase in external costs and an $18.5 million increase in personnel-related expenses[334]. - Research and development expenses decreased by $7.6 million for the three months and $40.6 million for the nine months ended September 30, 2025, compared to the same periods in 2024, mainly due to reprioritization of R&D programs[328]. Cash Flow and Liquidity - Cash, cash equivalents, and marketable securities as of September 30, 2025, totaled $645.9 million, down from $681.1 million as of December 31, 2024[317]. - The company reported net cash used in operating activities of $389.5 million for the nine months ended September 30, 2025, primarily due to a net loss of $538.3 million[396]. - The company experienced a net cash outflow of $100.7 million related to changes in operating assets and liabilities, mainly due to an increase in accounts receivable[396]. - Net cash used in investing activities was $10.1 million for the nine months ended September 30, 2025, primarily due to purchases of marketable securities of $10.9 million[398]. Debt and Financing - The company had cash, cash equivalents, and marketable securities totaling $645.9 million as of September 30, 2025, while outstanding debt stood at $1.9 billion[350]. - The principal balances of the company's 2031 Notes, 2029 Notes, and 2027 Notes were $575.0 million, $747.5 million, and $550.0 million, respectively, with fixed interest rates[406]. - The company issued $550.0 million of 2027 Notes in March 2020, with net proceeds of approximately $537.0 million after expenses[373]. - The Bayer License Agreement entitles BridgeBio to an upfront payment of $135.0 million and potential milestone payments up to $600.0 million through 2026[312]. Regulatory and Product Development - BridgeBio has created 19 Investigational New Drug applications (INDs) and received FDA approval for three products since its inception in 2015[301]. - BridgeBio's commercial product, acoramidis, received FDA approval on November 22, 2024, and subsequent approvals in Europe and Japan[303]. - Product sales of Attruby, approved on November 22, 2024, are expected to provide a growing source of operating cash flow starting in 2025[394]. Other Financial Metrics - Interest income for the three months ended September 30, 2025, was $6.2 million, an increase of $2.9 million (88.2%) compared to $3.3 million in the same period in 2024[337]. - Interest expense decreased by $11.3 million (49.0%) for the three months ended September 30, 2025, totaling $(11.7) million compared to $(23.1) million in 2024[338]. - The company recognized a loss on extinguishment of debt of $21.2 million for the three months ended September 30, 2025, following the repayment of the term loan under the Amended Financing Agreement[344]. - Other income, net increased by $14.7 million (817.0%) for the three months ended September 30, 2025, totaling $16.5 million compared to $1.8 million in the same period in 2024[346].

Financial Performance - Total third quarter revenue reached $120.7 million, with $108.1 million from U.S. Attruby net product revenue, $4.3 million from royalty revenue, and $8.3 million in license and services revenue[2]. - Total revenues for the nine months ended September 30, 2025, were $347.9 million, a $131.9 million increase from the prior year, primarily driven by a $216.4 million increase in net product revenue from Attruby[14]. - The company reported net product revenue of $108.1 million for the three months ended September 30, 2025, compared to no revenue in the same period of 2024, and total revenues of $120.7 million for the same quarter[27]. - The net loss attributable to common stockholders for the three months ended September 30, 2025, was $182.7 million, compared to $162.0 million for the same period in 2024[24]. - Net loss for the nine months ended September 30, 2025, was $538.3 million, compared to a net loss of $276.0 million for the same period in 2024[34]. - Cash used in operating activities increased to $389.5 million in 2025 from $325.4 million in 2024[34]. - Cash paid for interest decreased to $43.7 million in 2025 from $78.2 million in 2024[37]. - Cash, cash equivalents, and restricted cash at the end of the period were $645.1 million, up from $407.9 million in 2024[35]. - Net cash provided by financing activities was $361.5 million in 2025, compared to $274.5 million in 2024[35]. Research and Development - The Phase 3 study of BBP-418 showed a 1.8x increase in glycosylated αDG from baseline at 3 months (p<0.0001) and an average reduction in serum CK of 82% at 12 months (p<0.0001) compared to placebo[2]. - The primary endpoint of the CALIBRATE Phase 3 study for encaleret was met, with 76% of participants achieving target calcium levels at Week 24 compared to 4% on conventional therapy (p<0.0001)[11]. - The company plans to file NDAs for both BBP-418 and encaleret with the FDA in the first half of 2026[2]. - The company expects topline results from the PROPEL 3 study of infigratinib in early 2026, with the study fully enrolled[11]. - BridgeBio plans to initiate clinical trials of encaleret in pediatric ADH1 and chronic hypoparathyroidism in 2026[2]. - The company has a robust pipeline with multiple upcoming milestones, including data sharing from the Phase 3 ACCEL 2/3 study in hypochondroplasia in 2026[2]. - The company emphasizes the potential for BBP-418 to become the first approved treatment for LGMD2I/R9[43]. Operating Expenses - For the three months ended September 30, 2025, total operating costs and expenses were $265.9 million, an increase of $71.4 million from $194.5 million in the same period of 2024, primarily driven by a $68.8 million increase in selling, general and administrative expenses[15]. - For the nine months ended September 30, 2025, total operating costs and expenses were $731.7 million, up from $583.0 million in the prior year, reflecting a $179.0 million increase in selling, general and administrative expenses[17]. - Stock-based compensation expenses for the three months ended September 30, 2025, were $35.3 million, an increase from $27.1 million in the same period of 2024[18]. - Total other income (expense), net for the three months ended September 30, 2025, was $(41.3) million, a decrease of $68.8 million compared to $27.5 million in the prior year[20]. Patient and Prescription Data - As of October 25, 2025, there have been 5,259 unique patient prescriptions written by 1,355 unique prescribers, indicating strong month-over-month growth in the treatment naïve patient segment[2]. Cash and Assets - BridgeBio ended the quarter with $645.9 million in cash, cash equivalents, and marketable securities, providing strong capital to advance its pipeline[2]. - Cash, cash equivalents, and marketable securities as of September 30, 2025, totaled $645.9 million, down from $681.1 million at the end of 2024[30]. - The company had total assets of $998.3 million as of September 30, 2025, compared to $919.3 million at the end of 2024[30]. Product Information - Attruby is indicated for the treatment of cardiomyopathy of transthyretin-mediated amyloidosis (ATTR-CM) in adults[39]. - Adverse reactions for Attruby included diarrhea (11.6% vs 7.6% for placebo) and upper abdominal pain (5.5% vs 1.4% for placebo)[40].

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]

PresentationI now would like to turn the conference over to Jean-François Boucher, ADF Group's Chief Financial Officer. Please go ahead, sir.Good morning, ladies and gentlemen, and welcome to the ADF Group Inc. Presentation for Acquisition of LAR Groupe. [Operator Instructions] Also note that this call is being recorded on Wednesday, October 29, 2025.Jean-François BoursierChief Financial Officer Thank you. Good morning, and welcome to ADF's conference call, where we will provide additional information about ...

Core Insights - The company announced positive Phase III data from the CALIBRATE clinical trial for patients with autosomal dominant hypocalcemia type 1, marking a significant advancement for ADH1 patients [2][3]. Group 1 - The webinar was hosted by the company to present the top line results of the CALIBRATE Phase III trial [1]. - The CEO expressed gratitude towards the team and stakeholders involved in the trial, highlighting the importance of the results for patients and their families [2].

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.