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BridgeBio Pharma, Inc.

BBIO
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Business Summary

BridgeBio Pharma, Inc. is a commercial-stage, multi-product biopharmaceutical company that focuses on discovering, developing, and delivering medicines for patients with genetic diseases, utilizing a decentralized hub-and-spoke operating model. The company aims to translate genetic science advancements into therapies for patient populations with significant unmet medical needs, emphasizing capital efficiency with an average investment of less than $40.0 million to proof-of-concept data and less than $10.0 million to reach Investigational New Drug (IND) submission. BridgeBio evaluates performance at the portfolio level based on progress across development milestones, regulatory approvals, and commercialization, and its ability to reallocate resources as data emerge. The company's objective is to develop medicines that meaningfully improve patient outcomes and maximize positive impact on quality-adjusted life-years as quickly as possible, by advancing programs underpinned by clear genetic drivers, established disease mechanisms, and therapeutic approaches designed to address the underlying cause of disease .

The core business model revolves around a portfolio operating model, where "spokes" are program-specific teams responsible for research, development, and scientific leadership for individual conditions or product candidates, structured as dedicated, minimum viable development units. The "hub" consists of centralized functions providing shared business and finance operations, clinical and regulatory expertise, and the commercial platform. This structure allows for separation of asset-level scientific development from enterprise-level execution, supports disciplined capital allocation, and scales the commercial platform for existing and future products. Revenue is generated through product sales, as well as license and service agreements and royalty payments from collaboration partners. The primary customer segments are patients with genetic diseases, with a focus on rare and genetically defined conditions.

BridgeBio's largest commercial product is Attruby (acoramidis), approved by the FDA in November 2024 for the treatment of transthyretin amyloid cardiomyopathy (ATTR-CM) in adults to reduce cardiovascular death and cardiovascular-related hospitalization. Attruby generated $362.4 million in U.S. net product revenues in 2025. As of February 20, 2026, Attruby has achieved 7,804 unique patient prescriptions in the United States and 1,856 prescribing healthcare professionals . Outside the United States, acoramidis is marketed as Beyonttra and is commercialized through strategic collaboration partners, including Bayer in Europe and Alexion in Japan, as well as directly by BridgeBio in certain international markets. Beyonttra contributed $105.0 million in license and services revenue and $11.4 million in royalty revenue in 2025.

The company also has other commercial products: Nulibry (fosdenopterin) for Molybdenum Cofactor Deficiency (MoCD) Type A, which was approved by the FDA in February 2021. In March 2022, BridgeBio sold global rights to NULIBRY to Sentynl Therapeutics, Inc. and did not generate significant royalty revenue from NULIBRY in 2025. TRUSELTIQ (infigratinib) for cholangiocarcinoma, which received accelerated approval from the FDA in May 2021 but had its approval withdrawn in May 2023. The intellectual property related to infigratinib is still utilized in ongoing clinical investigations for other FGFR-related conditions.

BridgeBio's Phase 3 registrational programs include infigratinib for achondroplasia, BBP-418 for Limb-Girdle Muscular Dystrophy Type 2I/R9 (LGMD2I/R9), and encaleret for Autosomal Dominant Hypocalcemia Type 1 (ADH1). Infigratinib for achondroplasia reported positive Phase 3 topline results in February 2026, meeting all primary and secondary endpoints with a mean treatment difference in annualized height velocity of +2.10 cm/year versus placebo at Week 52. Encaleret for ADH1 reported positive Phase 3 topline results in October 2025, with 76% of participants achieving both serum and urine calcium within target ranges on encaleret, compared to 4% on conventional therapy. BBP-418 for LGMD2I/R9 also reported positive interim Phase 3 topline results in October 2025, demonstrating a statistically significant near doubling (1.8-fold increase) in glycosylated αDG from baseline at 3 months compared to placebo.

For the fiscal year ended December 31, 2025, the company reported total revenue of $478.8 million , which includes $362.4 million in product revenue, $105.0 million in license and services revenue, and $11.4 million in royalty revenue. The cost of sales was $10.3 million . Research and development expenses were $456.0 million , selling, general and administrative expenses were $362.0 million , restructuring, impairment and related charges were $23.4 million , and performance-based milestone awards were $2.0 million . The company reported a net loss of $375.0 million and a diluted net loss per share of $2.01 . Cash and cash equivalents were $412.0 million as of December 31, 2025. Total debt, including current and non-current portions of convertible senior notes and the term loan, was $1,575.0 million for the 2031 Notes, $575.0 million for the 2029 Notes, $575.0 million for the 2027 Notes, and $467.0 million for the Term Loan, as of December 31, 2025.

Year-over-year, product revenue from Attruby increased significantly from $0 in 2024 to $362.4 million in 2025, following its FDA approval in November 2024. License and services revenue increased from $10.3 million in 2024 to $105.0 million in 2025, driven by the $75.0 million regulatory milestone payment from Bayer and the $30.0 million regulatory milestone payment from Alexion. Royalty revenue increased from $0 in 2024 to $11.4 million in 2025. Total revenue grew from $10.3 million in 2024 to $478.8 million in 2025. Research and development expenses increased from $362.0 million in 2024 to $456.0 million in 2025. Selling, general and administrative expenses increased from $362.0 million in 2024 to $362.0 million in 2025. The company recognized a loss on extinguishment of debt of $21.2 million in 2025 related to the full repayment of the Amended Financing Agreement.

Significant operational developments during the period include the FDA approval of Attruby in November 2024, followed by its U.S. launch. Beyonttra received European Commission, UK, and Japan approvals in the first half of 2025. The company reported positive Phase 3 topline results for infigratinib in achondroplasia in February 2026, positive Phase 3 topline results for encaleret in ADH1 in October 2025, and positive interim Phase 3 topline results for BBP-418 in LGMD2I/R9 in October 2025. BridgeBio also completed a Royalty Interest Purchase and Sale Agreement on June 27, 2025, selling certain royalty rights for $300.0 million in cash. The company issued $575.0 million principal amount of 2031 Notes in February 2025, with net proceeds of approximately $563.0 million , and used a portion to repay the $450.0 million outstanding principal of the Initial Term Loan.

Business Outlook

BridgeBio plans to continue its collaborations with Bayer and Alexion in 2026 to drive continued growth for Beyonttra in Europe and Japan, respectively. The company expects to progress its Phase 3 programs for infigratinib, BBP-418, and encaleret towards anticipated approvals in the United States and Europe during 2026, actively preparing for worldwide commercial launches if approved.

Regarding growth areas, infigratinib for achondroplasia is expected to have an NDA submission to the FDA and an MAA submission to the EMA in the second half of 2026, following positive Phase 3 results. The company believes low-dose infigratinib, if approved, would have meaningful commercial potential in a total global market opportunity estimated to exceed $5.0 billion for achondroplasia and other FGFR-driven skeletal dysplasias. The PROPEL infant and toddler study (PROPEL I&T) for oral infigratinib in infants and young children with achondroplasia has dosed its first participant, and an open-label, long-term extension study is ongoing to evaluate long-term safety, tolerability, and efficacy. The company also plans to study infigratinib for hypochondroplasia in 2027, with enrollment in the Phase 2 portion of ACCEL 2/3 completed and proof-of-concept results expected in the second half of 2026.

Encaleret for ADH1 is slated for an NDA submission to the FDA in the first half of 2026, followed by an MAA to the EMA, based on positive Phase 3 CALIBRATE trial data. The estimated market for ADH1 includes 25,000 carriers of ADH1-causative variants in the EU and US. Furthermore, BridgeBio plans to initiate a registrational Phase 2/3 study of encaleret in pediatric ADH1 in the first quarter of 2026 and a registrational Phase 3 study in adults with Chronic Hypoparathyroidism (CHP) in the summer of 2026. CHP represents a larger potential patient population with an estimated 200,000 patients in the US and Europe.

BBP-418 for LGMD2I/R9 is planned for an NDA submission to the FDA in the first half of 2026, following positive interim Phase 3 FORTIFY study results. The disease affects an estimated 7,000 individuals across the United States and Europe, including patients with LGMD2I/R9 and other potentially addressable dystroglycanopathies. If approved, BBP-418 may be eligible for a Priority Review Voucher under the Rare Pediatric Disease program.

BridgeBio is also developing a next-generation depleter program for ATTR-CM, currently in preclinical development, with plans to advance it into the clinic in 2027–2028. This monoclonal antibody is designed to selectively bind misfolded, amyloidogenic TTR and promote clearance, potentially complementing existing ATTR-CM therapies. The company maintains minority equity interests in GondolaBio, LLC (27.5% ownership interest as of December 31, 2025) and BridgeBio Oncology Therapeutics, Inc. (18.2% ownership interest as of December 31, 2025), which offer exposure to early-stage development opportunities. GondolaBio intends to initiate a Phase 2b/3 clinical trial for PORT-77 in erythropoietic protoporphyria (EPP) in 2026.

In terms of capital allocation, BridgeBio issued $632.5 million principal amount of 2033 Notes on January 21, 2026, as a subsequent event. The company used approximately $48.3 million of the net proceeds from the 2025 Note Offering to repurchase shares of its common stock and fully repaid the Amended Financing Agreement for $467.0 million in February 2025.

Management explicitly flagged several structural headwinds and execution risks. The commercial success of Attruby and Beyonttra, and future product candidates, is dependent on market acceptance by physicians, patients, and healthcare payors. The company's ability to penetrate foreign markets subjects it to additional regulatory burdens and other risks. Healthcare legislative measures aimed at reducing costs, such as the Inflation Reduction Act of 2022 (IRA) and potential reference pricing or most-favored-nation (MFN) pricing models, could impact product revenues and harm the business. The company also faces significant competition from established pharmaceutical and biotechnology companies, with competitors potentially achieving commercial success or regulatory approval before BridgeBio or developing safer, more advanced, or more effective therapies.

Risk Factors

BridgeBio faces substantial risks, including its heavy dependence on the commercial success of Attruby and Beyonttra, which relies on market acceptance by physicians, patients, and healthcare payors. The company's profitability is significantly tied to its ability to sell products at competitive prices and secure adequate coverage and reimbursement from governmental or private third-party payors, with the approved list price of Attruby in the United States being $18,759.12 for a 28-day supply through December 2025, increasing to $19,790.00 in January 2026. Failure to comply with healthcare laws, including the federal Anti-Kickback Statute and False Claims Act, could result in substantial penalties, such as imprisonment, criminal fines, administrative civil money penalties, and exclusion from federal healthcare programs. Healthcare legislative measures, including the Inflation Reduction Act of 2022 (IRA) and potential federal and state efforts to implement reference pricing or most-favored-nation (MFN) pricing models, could materially adversely affect the business by reducing product revenues and increasing rebate obligations. For example, the proposed GLOBE and GUARD models could impose additional mandatory rebates on manufacturers of certain Medicare Part B and Part D drugs for select Medicare populations, representing 25% of Medicare patients, if Medicare prices exceed those in economically comparable countries. The company operates in a highly competitive biopharmaceutical industry, where competitors may achieve commercial success or regulatory approval sooner or develop superior therapies. Clinical trials are expensive, time-consuming, and uncertain, with potential for substantial delays due to factors like patient enrollment difficulties or adverse events, and preliminary or interim data may not be predictive of final results. The novel nature of certain product candidates, such as gene therapies, presents manufacturing complexities and limited clinical or regulatory experience, making development time and cost difficult to predict. Reliance on third-party manufacturers for commercial supplies and clinical trial materials exposes the company to risks of supply disruptions or failures to meet regulatory requirements. Furthermore, the ability to obtain and maintain sufficient intellectual property protection for its products and product candidates is critical, as patent terms may be inadequate, and third-party claims of infringement could prevent or delay commercialization efforts.

Management Priorities

Management's overall tone emphasizes BridgeBio's evolution into a commercial-stage biopharmaceutical company with multiple approved products and a growing global commercial footprint, alongside a robust portfolio of late-stage development programs. They highlight the company's decentralized hub-and-spoke model as a key enabler of speed and efficiency in achieving clinical proof-of-concept, citing an average investment per program of less than $40.0 million to proof-of-concept data and less than $10.0 million to reach IND submission. Strategic priorities for the period ahead include driving continued commercial momentum for Attruby and Beyonttra, progressing multiple Phase 3 programs towards anticipated regulatory approvals in the United States and Europe during 2026, and actively preparing for the worldwide commercial launches of these products, if approved. Management also underscores the continued focus on early-stage development, including expansion indications and the initiation of new registrational studies, such as encaleret in chronic hypoparathyroidism and pediatric ADH1 in 2026, and studying infigratinib for hypochondroplasia in 2027.

View Source Annual Report on SEC.gov ↗

References

  1. [1] Item 1, Business — Overview
  2. [2] Item 1, Business — Overview
  3. [3] Item 1, Business — Overview
  4. [4] Item 1, Business — Overview
  5. [5] Item 1, Business — Overview
  6. [6] Item 1, Business — Our Objective Function and How We Define Success
  7. [7] Item 1, Business — ATTRUBY Summary
  8. [8] Item 1, Business — ATTRUBY Summary
  9. [9] Item 1, Business — ATTRUBY Summary
  10. [10] Item 1, Business — ATTRUBY Summary
  11. [11] Item 1, Business — ATTRUBY Summary
  12. [12] Item 1, Business — Infigratinib for Achondroplasia Summary
  13. [13] Item 1, Business — Encaleret for the treatment of Autosomal Dominant Hypocalcemia Type 1 Summary
  14. [14] Item 1, Business — Encaleret for the treatment of Autosomal Dominant Hypocalcemia Type 1 Summary
  15. [15] Item 1, Business — BBP-418 for the treatment of Limb Girdle Muscular Dystrophy Type 2I/R9 Summary
  16. [16] Item 7, Management's Discussion and Analysis of Financial Condition and Results of Operations — Consolidated Results of Operations
  17. [17] Item 7, Management's Discussion and Analysis of Financial Condition and Results of Operations — Consolidated Results of Operations
  18. [18] Item 7, Management's Discussion and Analysis of Financial Condition and Results of Operations — Consolidated Results of Operations
  19. [19] Item 7, Management's Discussion and Analysis of Financial Condition and Results of Operations — Consolidated Results of Operations
  20. [20] Item 7, Management's Discussion and Analysis of Financial Condition and Results of Operations — Consolidated Results of Operations
  21. [21] Item 7, Management's Discussion and Analysis of Financial Condition and Results of Operations — Consolidated Results of Operations
  22. [22] Item 7, Management's Discussion and Analysis of Financial Condition and Results of Operations — Consolidated Results of Operations
  23. [23] Item 7, Management's Discussion and Analysis of Financial Condition and Results of Operations — Consolidated Results of Operations
  24. [24] Item 7, Management's Discussion and Analysis of Financial Condition and Results of Operations — Consolidated Results of Operations
  25. [25] Item 7, Management's Discussion and Analysis of Financial Condition and Results of Operations — Consolidated Results of Operations
  26. [26] Item 7, Management's Discussion and Analysis of Financial Condition and Results of Operations — Consolidated Results of Operations
  27. [27] Item 7, Management's Discussion and Analysis of Financial Condition and Results of Operations — Liquidity and Capital Resources
  28. [28] Item 7, Management's Discussion and Analysis of Financial Condition and Results of Operations — Liquidity and Capital Resources
  29. [29] Item 7, Management's Discussion and Analysis of Financial Condition and Results of Operations — Liquidity and Capital Resources
  30. [30] Item 7, Management's Discussion and Analysis of Financial Condition and Results of Operations — Liquidity and Capital Resources
  31. [31] Item 7, Management's Discussion and Analysis of Financial Condition and Results of Operations — Liquidity and Capital Resources
  32. [32] Item 7, Management's Discussion and Analysis of Financial Condition and Results of Operations — Consolidated Results of Operations
  33. [33] Item 7, Management's Discussion and Analysis of Financial Condition and Results of Operations — Consolidated Results of Operations
  34. [34] Item 7, Management's Discussion and Analysis of Financial Condition and Results of Operations — Consolidated Results of Operations
  35. [35] Item 7, Management's Discussion and Analysis of Financial Condition and Results of Operations — Consolidated Results of Operations
  36. [36] Item 1, Business — Acoramidis (Attruby/Beyonttra) License Agreement with Bayer
  37. [37] Item 1, Business — License Agreement with Alexion
  38. [38] Item 7, Management's Discussion and Analysis of Financial Condition and Results of Operations — Consolidated Results of Operations
  39. [39] Item 7, Management's Discussion and Analysis of Financial Condition and Results of Operations — Consolidated Results of Operations
  40. [40] Item 7, Management's Discussion and Analysis of Financial Condition and Results of Operations — Consolidated Results of Operations
  41. [41] Item 7, Management's Discussion and Analysis of Financial Condition and Results of Operations — Consolidated Results of Operations
  42. [42] Item 7, Management's Discussion and Analysis of Financial Condition and Results of Operations — Consolidated Results of Operations
  43. [43] Item 7, Management's Discussion and Analysis of Financial Condition and Results of Operations — Consolidated Results of Operations
  44. [44] Item 7, Management's Discussion and Analysis of Financial Condition and Results of Operations — Consolidated Results of Operations
  45. [45] Item 7, Management's Discussion and Analysis of Financial Condition and Results of Operations — Consolidated Results of Operations
  46. [46] Item 7, Management's Discussion and Analysis of Financial Condition and Results of Operations — Consolidated Results of Operations
  47. [47] Item 1, Business — Corporate Royalty Interest Purchase and Sale Agreement
  48. [48] Item 1, Business — 2031 Notes
  49. [49] Item 1, Business — 2031 Notes
  50. [50] Item 1, Business — Financing Agreement
  51. [51] Item 1, Business — Infigratinib for Achondroplasia Summary
  52. [52] Item 1, Business — Encaleret for the treatment of Autosomal Dominant Hypocalcemia Type 1 Summary
  53. [53] Item 1, Business — Encaleret for the treatment of Chronic Hypoparathyroidism ("CHP")
  54. [54] Item 1, Business — BBP-418 for the treatment of Limb Girdle Muscular Dystrophy Type 2I/R9 Summary
  55. [55] Item 1, Business — GondolaBio
  56. [56] Item 1, Business — BridgeBio Oncology Therapeutics, Inc.
  57. [57] Item 1, Business — Subsequent Event - 2033 Notes, net
  58. [58] Item 1, Business — 2031 Notes
  59. [59] Item 1, Business — Financing Agreement
  60. [60] Item 1A, Risk Factors — Our profitability will depend significantly on our ability to sell enough product at competitive prices and on the availability of adequate coverage and reimbursement through governmental or private third-party payors.
  61. [61] Item 1A, Risk Factors — Our profitability will depend significantly on our ability to sell enough product at competitive prices and on the availability of adequate coverage and reimbursement through governmental or private third-party payors.
  62. [62] Item 1A, Risk Factors — Federal legislative and regulatory efforts to implement reference pricing or most-favored-nation pricing models could impact our product revenues and materially harm our business.
  63. [63] Item 1, Business — Overview
  64. [64] Item 1, Business — Overview

Analysis on 5/22/2026