BridgeBio Pharma NASDAQ: BBIO reported third-quarter revenue growth driven by sales of ATTR cardiomyopathy treatment Attruby and a one-time milestone tied to European partner Bayer’s commercialization of Beyonttra. The company also outlined plans for three potential U.S. product launches over the next seven months, subject to Food and Drug Administration decisions.
Total revenue for the third quarter of 2026 was $353.2 million, compared with $120.7 million a year earlier. U.S. Attruby net product revenue reached $253.2 million, up 14% sequentially and 134% year over year. Revenue also included a $75 million one-time Beyonttra sales milestone from Bayer and $20.5 million in royalty revenue, primarily from Beyonttra sales in Europe and Japan.
President and Chief Financial Officer Tom Trimarchi said the company recorded an operating loss of $11.6 million, improving from a $145.2 million operating loss in the prior-year quarter. Operating expenses rose to $344.4 million from $259.3 million as BridgeBio invested in Attruby and prepared for upcoming launches.
As of Sept. 30, BridgeBio held $1.5 billion in cash, cash equivalents and marketable securities, which Trimarchi described as the company’s strongest reported cash position. He said the company expects operating expenses to increase in the fourth quarter as launch-related spending catches up, followed by more modest expense growth and improving operating results through 2027.
Attruby growth and real-world evidence
Chief Executive Officer Neil Kumar said BridgeBio’s Attruby/Beyonttra franchise is annualizing at more than $1 billion in the U.S. market and above that level globally. He reiterated the company’s belief that the franchise can meet or exceed its $4 billion peak-sales assumption.
Kumar said growth in the U.S. is increasingly being driven by first-line patient starts. BridgeBio has seen Attruby prescribed by roughly 2,900 physicians, largely cardiologists at academic medical centers and high-volume heart-failure practices. He said more than 60% of potential prescribers have yet to try the product, with many of those clinicians being lower-volume or non-cardiology specialists.
During the question-and-answer session, Chief Business Officer Chinmay Shukla said a quarterly Attruby revenue increase of roughly $25 million to $30 million is the appropriate near-term expectation, with potential for that figure to rise over time. Chief Commercial Officer Matt Outten said persistency, compliance and gross-to-net trends have remained stable, while the number of physicians initiating Attruby in the first-line setting continues to expand.
Management highlighted two recent comparative real-world analyses of acoramidis, the active ingredient in Attruby, versus tafamidis. Kumar said a study using Komodo U.S. claims data found acoramidis was associated with a 34% reduction in composite clinical worsening and a 43% reduction in diuretic intensification compared with tafamidis. Separately, an analysis presented at the Heart Failure Society of America meeting using Epic Cosmos electronic health record data associated acoramidis with lower risks of a composite of death, hospitalization, new-onset atrial fibrillation and diuretic intensification.
BridgeBio also said Bayer’s Beyonttra launch has been strong in Europe, where Kumar said the brand is the market leader. The company received the $75 million sales milestone earlier than it had expected.
Three regulatory decisions ahead
BridgeBio expects FDA decisions on three programs in the coming months:
- BBP-418 for limb-girdle muscular dystrophy type 2I/R9: PDUFA date of Nov. 27, 2026. The company said no advisory committee meeting is planned. If approved, it would be the first therapy for any limb-girdle muscular dystrophy.
- Infigratinib for achondroplasia: Priority-review PDUFA date of Feb. 4, 2027. BridgeBio has also submitted a European marketing application and expects a potential European decision in the second half of 2027.
- Encaleret for autosomal dominant hypocalcemia type 1, or ADH1: Priority-review PDUFA date of May 8, 2027. No advisory committee is planned, according to the company.
For BBP-418, BridgeBio said it has identified more than 500 genetically diagnosed U.S. patients and that about 70% receive care through the Muscular Dystrophy Association Care Center Network. Anna Wade, chief operating officer of BridgeBio Neuromuscular, said the company expects its account managers to reach more than 90% of those centers by the PDUFA date. She said BridgeBio’s discussions with FDA have remained positive and that management expects a traditional full approval rather than accelerated approval.
BridgeBio plans to submit a European marketing authorization application for BBP-418 in the first half of 2028, based on final 36-month FORTIFY trial data expected in late 2027 or early 2028. Wade said European health authorities requested the longer-term data, and BridgeBio estimates there are more than 4,000 patients in Europe with the condition.
Pipeline expansion and launch preparations
For infigratinib, management said the FDA granted priority review for the achondroplasia application. The company said its commercial field team is staffed and has been conducting disease-state education. Justin To, chief executive of BridgeBio Skeletal Dysplasias, said the company does not expect a citizen petition from competitor Ascendis to affect the FDA review timeline or potential label.
For encaleret, BridgeBio said it has identified more than 600 genetically confirmed ADH1 patients in the U.S., up from about 500 in the previous quarter. The company is also expanding the drug’s development into chronic hypoparathyroidism. It dosed the first participant in the global Phase III RECLAIM-HP study in October.
The RECLAIM-HP study is expected to enroll approximately 160 patients and evaluates the proportion of participants achieving normal blood and urine calcium at week 24. Ananth Sridhar, chief operating officer of BridgeBio Cardiorenal, said BridgeBio estimates the chronic hypoparathyroidism population at roughly 200,000 people in the U.S. and Europe, compared with about 25,000 people with ADH1 in those markets. The company anticipates top-line results from RECLAIM-HP within 15 months.
Kumar also said BridgeBio nominated BBP-717, a next-generation monoclonal antibody program for ATTR cardiomyopathy, as a development candidate. The company plans to file an investigational new drug application for the program in 2027.
About BridgeBio Pharma (NASDAQ:BBIO)
BridgeBio Pharma, Inc is a biopharmaceutical company focused on discovering, developing and commercializing medicines for genetically driven diseases. The company operates through a portfolio of subsidiary and affiliated biotechnology businesses, with research programs spanning rare diseases, oncology, cardiology and other conditions linked to underlying genetic or molecular causes.
BridgeBio's portfolio includes therapies designed to address the root mechanisms of disease rather than primarily treating symptoms.
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