BridgeBio Plans Four Global Launches by 2027 as Attruby Annualizes Above $1 Billion
核心洞察
BridgeBio Pharma expects to expand from one commercial product to four globally launched therapies by 2027, according to President and CFO Thomas Trimarchi.
Attruby, the company's ATTR cardiomyopathy (搜索) treatment, is annualizing at more than $1 billion globally about six quarters after launch and holds roughly 25% of new patient starts.
Real-world data showed acoramidis delivered a 34% improvement over tafamidis on a composite of diuretic intensification, cardiovascular hospitalizations and all-cause mortality.
BridgeBio Pharma expects 2027 to mark its expansion from a single commercial product to four globally launched therapies, President and CFO Thomas Trimarchi said during a Bernstein discussion. The company's strategy centers on developing medicines for genetic diseases with substantial unmet need, particularly where a genetic mechanism can be directly targeted, he said, adding that capital allocation discipline and net present value considerations shape the operating model.
"We are here in this world to help as many patients living with genetic disease as we possibly can in the shortest amount of time," Trimarchi said.
Attruby Builds Commercial Momentum in ATTR Cardiomyopathy
Attruby, the company's treatment for ATTR cardiomyopathy (搜索), is annualizing at more than $1 billion globally about six quarters after launch, according to Trimarchi. BridgeBio expects the drug to reach global blockbuster status on a full-year basis by the end of the year.
The company estimates that 15,000 to 16,000 patients annually are now reaching the "bottom of the funnel" in the ATTR cardiomyopathy (搜索) market, compared with an estimated 8,000 patients two years earlier. Trimarchi said Attruby holds about 25% share of new patient starts and that share is growing.
BridgeBio recently released real-world data comparing acoramidis, the active ingredient in Attruby, with tafamidis. According to Trimarchi, the analysis showed a 34% improvement for acoramidis on a composite measure of diuretic intensification, cardiovascular hospitalizations and all-cause mortality. He said the company also published data suggesting a kidney-protective effect, although the mechanism remains under investigation.
Julie Miller Everett, chief operating officer of BridgeBio's Skeletal Dysplasias Business, said emerging evidence across the category has reinforced the company's confidence in Attruby's differentiation. BridgeBio continues to project more than $4 billion in peak-year sales for acoramidis.
Trimarchi said the company expects quarterly Attruby revenue increases of approximately $25 million to $30 million for the next several quarters, potentially through late 2027. He attributed the near-term pace partly to normalization in switches from tafamidis and to the changing mix between second-line and treatment-naive patients.
Lifecycle-management efforts for acoramidis include the ACT-EARLY primary-prevention study in certain asymptomatic variant patients, a cardiac imaging study, further research into the renal findings, and a once-daily formulation that Trimarchi said could enter the clinic within 12 to 18 months.
BBP-418 and Encaleret Advance Toward Regulatory Decisions
Among the planned launches, BBP-418 is being developed for Limb-Girdle Muscular Dystrophy Type 2I/R9 (搜索). Trimarchi described the condition as a progressive disease with no approved therapy, affecting an estimated 2,000 to 2,500 people in the U.S., approximately 5,000 in Europe, and another roughly 2,000 patients in Japan with related Fukuyama Muscular Dystrophy.
He said BBP-418's Phase 3 trial showed statistically significant benefits versus placebo across measures including the North Star Ambulatory Assessment, forced vital capacity and a 10-meter walk test. BridgeBio expects an FDA decision on or before a Nov. 27, 2026, PDUFA date. Trimarchi said the company has identified about 500 U.S. patients with confirmed genotypes and mapped prescribers, which will form the initial launch pool.
BridgeBio also has encaleret under FDA review for autosomal dominant hypocalcemia type 1 (搜索), or ADH1. Trimarchi said the therapy is designed to address activating mutations in the calcium-sensing receptor (搜索). In its Phase 3 study, more than 75% of patients discontinued conventional calcium and vitamin D therapy and achieved normal-range blood and urine calcium levels after six months, he said.
Encaleret has a May 8 PDUFA date. BridgeBio has begun a Phase 3 study in postsurgical hypoparathyroidism (搜索), and Trimarchi said the company expects to enroll that study next year and potentially report results from late 2027 to early 2028.
Infigratinib Targets the FGFR3 Mutation in Achondroplasia
Miller Everett outlined BridgeBio's planned launch approach for infigratinib in achondroplasia (搜索). She said the oral therapy directly targets the FGFR3 (搜索) mutation associated with the condition, unlike currently available CNP analog treatments.
According to Miller Everett, infigratinib demonstrated statistically significant benefits in annualized height velocity and proportionality within 52 weeks. BridgeBio also presented data on otitis media, or ear infections, and sleep apnea, which she said showed benefits within 52 weeks.
She said only about 20% to 30% of U.S. families have opted for available treatment, compared with an estimated 70% to 80% outside the U.S. BridgeBio sees three potential sources of demand: untreated patients, patients seeking to move from injectable therapies, and patients who previously discontinued treatment.
BridgeBio has deployed medical personnel and is building commercial infrastructure in the U.S., while establishing country-specific commercialization models internationally. Trimarchi said the company sees the next 18 months as a period in which its four-product portfolio could support a broader, durable biopharmaceutical business.
BridgeBio Pharma is a biopharmaceutical company focused on discovering, developing and delivering medicines for patients with genetically driven diseases and cancers. Founded in 2015, the company operates through a group of subsidiary biotechnology businesses, each generally focused on a specific disease area or therapeutic program, with research and development spanning rare diseases, genetically defined cancers, cardiovascular conditions and other serious disorders.