BridgeBio Pharma Q2 2024 Financial Results and Business Update

BridgeBio Pharma, Inc., a biopharmaceutical company dedicated to addressing genetic diseases, has released its financial results for the second quarter ending June 30, 2024, and has provided an update on its ongoing operations. The company remains focused on preparing for the commercial launch of acoramidis and aims to fully enroll its three Phase 3 clinical programs by the end of 2024. Dr. Neil Kumar, CEO and Founder, highlighted BridgeBio's unique potential to deliver value to both patients and shareholders.

Key Developments

Acoramidis for ATTR-CM
Acoramidis, a treatment aimed at transthyretin amyloid cardiomyopathy (ATTR-CM), has shown promising results. Starting at Month 3, patients on acoramidis exhibited significant improvements in time to first cardiovascular hospitalization (CVH) or all-cause mortality (ACM). By Month 30, acoramidis demonstrated a 42% reduction in composite CVH and ACM events compared to placebo. Increased serum TTR levels by Day 28 correlated with a reduced risk of ACM, CVM, and CVH through Month 30. Additionally, acoramidis resulted in a statistically significant reduction in ACM in the intention-to-treat (ITT) population at Month 30.

During the 2024 International Symposium of Amyloidosis (ISA), data revealed that acoramidis led to increased serum transthyretin (TTR) levels by Day 28, sustained through Month 30, indicating a reduced risk of all-cause mortality, cardiovascular mortality, and hospitalization in participants with ATTR-CM. At the European Society of Cardiology Heart Failure (ESC-HF) Congress 2024, further analyses confirmed these findings and demonstrated improvements in health-related quality of life as assessed by the EuroQoL Health Outcomes Assessment tool and the Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary score.

Encaleret for ADH1
The Phase 3 clinical trial of encaleret, a calcium-sensing receptor inhibitor for autosomal dominant hypocalcemia type 1 (ADH1), continues to enroll participants. BridgeBio plans to share topline data from this trial in 2025.

BBP-418 for LGMD2I/R9
BridgeBio has surpassed its interim analysis enrollment target for its Phase 3 FORTIFY study of BBP-418, a glycosylation substrate for limb-girdle muscular dystrophy type 2I/R9 (LGMD2I/R9). Recent FDA interactions have reinforced the potential to pursue Accelerated Approval for BBP-418. If approved, the company could qualify for a Priority Review Voucher.

Low-Dose Infigratinib for Achondroplasia and Hypochondroplasia
BridgeBio shared data from Month 12 and 18 of its Phase 2 trial in achondroplasia, showing a significant increase in annualized height velocity (AHV) and improvement in body proportionality. The treatment continues to be well tolerated. Infigratinib for achondroplasia has received Fast Track and Rare Pediatric Drug Designations from the FDA, which could qualify BridgeBio for a Priority Review Voucher if approved. The first participant consented for the observational run-in study for infigratinib in hypochondroplasia in May 2024.

Financial Overview

Cash and Equivalents
BridgeBio ended the quarter with $587 million in cash, cash equivalents, marketable securities, and short-term restricted cash, up from $392.6 million as of December 31, 2023. This increase was primarily due to proceeds from term loans and various equity financings, offset by refinancing costs and net cash used in operating activities.

Revenue and Expenses
For the three months ended June 30, 2024, revenue was $2.2 million, compared to $1.6 million in the same period the previous year. For the six months ended June 30, 2024, revenue was $213.3 million, a significant increase from $3.5 million in the same period the prior year. This increase was largely due to non-refundable upfront payments and service revenue under exclusive license and collaboration agreements.

Operating costs and expenses for the three months ended June 30, 2024, totaled $177.7 million, compared to $147.7 million in the same period the prior year. For the six months ended June 30, 2024, operating costs and expenses were $388.5 million, up from $275.7 million in the same period the previous year. The increase was mainly due to expenses supporting commercialization readiness and advancements in the company's research and development pipeline.

Net Loss
BridgeBio reported a net loss attributable to common stockholders of $73.5 million for the three months ended June 30, 2024, compared to $157.9 million for the same period the previous year. For the six months ended June 30, 2024, the net loss was $108.7 million, compared to $298.1 million for the same period in 2023.

Conclusion
BridgeBio Pharma continues to advance its pipeline of treatments for genetic diseases, with significant progress in clinical trials for acoramidis, encaleret, BBP-418, and infigratinib. The company's financial health remains robust, enabling ongoing efforts in research, development, and potential commercialization of its treatments.

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