BridgeBio Pharma Q1 2024 Financial Results and Business Update

BridgeBio Pharma, Inc., a biopharmaceutical company specializing in genetic diseases and cancers, reported its financial outcomes for the first quarter ending March 31, 2024, and provided an update on its ongoing operations.

BridgeBio has made significant strides in advancing its pipeline and strengthening its financial position. During the American College of Cardiology Annual Scientific Sessions, the company showcased cardiac magnetic resonance imaging evidence indicating clinical improvements in patients with transthyretin amyloid cardiomyopathy (ATTR-CM) undergoing treatment with acoramidis. Detailed results from the ATTRibute-CM Phase 3 study of acoramidis are expected to be presented at various medical conferences in 2024, including the European Society of Cardiology Heart Failure conference and the International Symposium on Amyloidosis.

The company is optimistic about the potential for Accelerated Approval for BBP-418, following discussions with the FDA regarding glycosylated alpha dystroglycan levels as a surrogate endpoint. The FORTIFY Phase 3 trial of BBP-418 in limb-girdle muscular dystrophy type 2I/R9 is actively enrolling participants, with full enrollment anticipated in 2024.

Financially, BridgeBio secured up to $1.5 billion in a Q1 2024 capital campaign. This includes a European licensing agreement for acoramidis, a Japanese licensing deal for infigratinib in skeletal dysplasias, and other financing arrangements. The company also launched BridgeBio Oncology Therapeutics (BBOT) with $200 million in private financing to expedite the development of its precision oncology pipeline.

BridgeBio's Marketing Authorization Application (MAA) for acoramidis was accepted for review by the European Medicines Agency (EMA), with an expected approval in 2025. This follows the November 29, 2024, Prescription Drug User Fee Act (PDUFA) date set by the U.S. FDA for the New Drug Application (NDA) of acoramidis.

The first quarter of 2024 saw BridgeBio end with $520 million in cash and equivalents. This financial stability is attributed to various funding sources, including a $437.7 million term loan, $315.3 million from equity financings, and proceeds from sales of equity securities totaling $63.2 million.

Revenue for the quarter was $211.1 million, a significant increase from $1.8 million in the same period in 2023. This rise was primarily due to non-refundable upfront payments under licensing agreements with Bayer and Kyowa Kirin. Operating costs and expenses totaled $210.8 million, an increase from $128.0 million in the previous year, driven by higher research and development expenses and commercialization readiness efforts.

BridgeBio's late-stage programs include acoramidis for ATTR-CM, which is under review by both the EMA and the FDA. The company has entered into a licensing agreement with Bayer, granting them exclusive rights to commercialize acoramidis in Europe, in return for tiered royalties and milestone payments.

The PROPEL 3 global Phase 3 study of infigratinib in achondroplasia is ongoing, with completion expected in 2025. BridgeBio also plans to initiate a clinical program for hypochondroplasia in 2024.

The FORTIFY Phase 3 trial of BBP-418 continues to enroll participants globally, and the CALIBRATE Phase 3 trial of encaleret in autosomal dominant hypocalcemia type 1 (ADH1) is also progressing, with topline data expected in 2025.

The launch of BBOT aims to enhance the development of BridgeBio's oncology pipeline, with leadership from experienced professionals in the field. The $200 million financing for BBOT was led by prominent investment firms, including Cormorant Asset Management and Omega Funds.

BridgeBio's solid financial performance and strategic partnerships position the company for the potential U.S. launch of acoramidis by the end of 2024 and the delivery of three Phase 3 readouts in 2025.