BridgeBio Reports First Quarter 2025 Financial Results and Business Updates

- $36.7 million in first full quarter of U.S. Attruby™ net product revenue and as of April 25, 2025, 2,072 unique patient prescriptions written by 756 unique prescribers

- Observational run-in study for hypochondroplasia Phase 2 trial fully enrolled significantly ahead of schedule. The first participant was also dosed in the Phase 2 interventional study

- Proof-of-principle study of encaleret, an oral calcium-sensing receptor antagonist, in hypoparathyroidism resulted in 78% of N=9 study participants achieving concomitant normal blood and urine calcium within 5 days. The Company intends to advance development to enable registration in chronic hypoparathyroidism

- The Company ended the quarter with $540.6 million in cash and cash equivalents, which does not include $105 million in regulatory milestone payments anticipated in Q2 for ex-U.S. approvals of BEYONTTRA®

- Earnings call followed by question-and-answer period for the analyst and institutional investor community today, April 29, 2025 at 4:30 pm ET

PALO ALTO, Calif., April 29, 2025 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) ("BridgeBio” or the "Company”), a new type of biopharmaceutical company focused on genetic diseases, today announced its financial results for the first quarter ended March 31, 2025, and provided an update on the Company's revenue, commercial progress of Attruby, and key late-stage pipeline highlights.

Commercial Progress:

The first full quarter of Attruby net product revenue was $36.7 million. As of April 25, 2025, 2,072 unique patient prescriptions for Attruby have been written by 756 unique healthcare providers since FDA approval in November 2024.

"The increasing surge in patient prescriptions by doctors across the U.S. shows that the ATTR-CM community believes what we believe - Attruby delivers profound results for patients with separation from placebo in as early as three months, a 42% reduction in all-cause mortality and recurrent hospitalizations, and a 50% decrease in cardiovascular hospitalizations at 30 months,” said Matt Outten, Chief Commercial Officer of BridgeBio. "With the approval of BEYONTTRA in the EU, UK, and Japan, acoramidis is well positioned to become the global first line therapy of choice for ATTR-CM.”

Pipeline Overview:

Key Program Updates:

"I'm grateful that Attruby has found a place and is continuing to grow in the front line of the ATTR-CM paradigm,” said Neil Kumar, Ph.D., CEO and founder of BridgeBio. "This success is due to its stellar clinical efficacy, safety profile, and the access work we have done to ensure patients in need can get our drug. As we continue to demonstrate our commercial capabilities, I'm also pleased to observe our continued distinctive performance in clinical development - this quarter's announcements regarding our hypochondroplasia and hypoparathyroidism programs are good examples of our speed and breadth of capabilities.”

Attruby (acoramidis) - First near-complete (≥90%) transthyretin (TTR) stabilizer for treatment of transthyretin amyloid cardiomyopathy (ATTR-CM):

• Acoramidis was approved as BEYONTTRA by the European Commission in February 2025, the Japanese Ministry of Health, Labour, and Welfare (MHLW) Agency in March 2025, and the United Kingdom Medicines and Healthcare Products Regulatory Agency in April 2025 with all labels specifying near-complete stabilization of TTR.
• At this year's American College of Cardiology (ACC) Annual Scientific Sessions & Expo, BridgeBio shared a prespecified analysis that acoramidis achieved statistical significance with a 59% risk reduction for time to all-cause mortality or first cardiovascular-related hospitalization versus placebo in the ATTRibute-CM study subgroup of variant ATTR-CM patients.
• More data on the benefit of Attruby will be shared at the European Society of Cardiology Heart Failure Congress in May 2025 and at additional medical meetings in the second half of 2025.

BBP-418 - Glycosylation substrate for limb-girdle muscular dystrophy type 2I/R9 (LGMD2I/R9):

• FORTIFY is a Phase 3 clinical trial of BBP-418 in LGMD2I/R9, a rare genetic disorder caused by variants in the fukutin‑related protein (FKRP) gene that results in progressive muscle degeneration and damage, and eventual loss of functional independence. The trial is fully enrolled with 112 participants and is the largest prospective interventional study to ever be conducted in LGMD2I/R9.
• The study includes a planned interim analysis at 12 months focused on assessing a surrogate endpoint biomarker (glycosylated alpha-dystroglycan) to support a potential Accelerated Approval in the U.S.
• BridgeBio expects last participant - last visit and topline readout of the interim analysis cohort in the second half of 2025.
• If successful, BBP-418 would be the first approved therapy for individuals living with LGMD2I/R9.

Encaleret - Calcium-sensing receptor (CaSR) antagonist for autosomal dominant hypocalcemia type 1 (ADH1) and chronic hypoparathyroidism:

• CALIBRATE, the Phase 3 clinical trial of encaleret in ADH1, a genetic form of hypoparathyroidism, is fully enrolled with 71 participants. The registrational study is the largest prospective interventional study to ever be conducted in ADH1.
• BridgeBio expects last participant - last visit and to report topline results in the second half of 2025.
• If successful, encaleret would be the first approved therapy for individuals living with ADH1.
• A Phase 2 proof-of-principle clinical trial of encaleret in participants with hypoparathyroidism resulted in 78% of N=9 study participants achieving concomitant normal blood and urine calcium within 5 days. The Company intends to advance development to enable registration in chronic hypoparathyroidism.

Infigratinib - FGFR1-3 inhibitor for achondroplasia and hypochondroplasia:

• PROPEL 3, the Phase 3 clinical trial of infigratinib in achondroplasia, the most common form of disproportionate short stature, is fully enrolled with 114 participants randomized.
• BridgeBio expects to achieve last participant - last visit in the second half of 2025 and topline results in early 2026.
• The Company has reached regulatory alignment with the FDA on the clinical development plan for infigratinib in children with achondroplasia from birth to less than 3 years old. The Company expects to initiate clinical development in this important age range by the end of the year.
• The observational run-in study for the Phase 2 portion of ACCEL 2/3 clinical trial for individuals with hypochondroplasia achieved full enrollment significantly ahead of schedule. The first participant was also dosed in the Phase 2 portion of ACCEL 2/3.
• Supportive preclinical data shows single-digit nanomolar potency against pathogenic FGFR3 variants and improved skeletal growth in a mouse model of hypochondroplasia, supporting the advancement of infigratinib into clinical development for hypochondroplasia.
• If successful, infigratinib would be the first approved oral therapy for children living with achondroplasia and hypochondroplasia.

BBP-812 - Adeno-associated virus (AAV) 9 gene therapy for Canavan disease:

• Data from CANaspire, the ongoing clinical trial of BBP-812, were presented at the National Tay-Sachs & Allied Diseases Association (NTSAD) Annual Family Conference, showing that participants continue to have significant, sustained reductions in urine N-acetylaspartate (NAA) and meaningful, dose-dependent improvements in motor function compared to children with Canavan in the natural history study.
• Recent interactions with the FDA indicate alignment on an Accelerated Approval pathway based on the ongoing CANaspire trial for BBP-812 in Canavan disease using urine NAA as a surrogate endpoint. The FDA understands the unmet need for the condition and has expressed openness to collaborate with BridgeBio to bring this therapy to children living with the disease as quickly as possible.
• If successful, BBP-812 would be the first therapy for children born with Canavan disease.

Corporate Updates:

• BridgeBio priced $500 million aggregate principal amount of 1.75% convertible senior notes due 2031 ("2031 Notes”) in a private offering to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended. In connection with the offering, the Company granted the initial purchasers an option to purchase up to an additional $75 million aggregate principal amount of notes. The net proceeds BridgeBio received from the Note Offering were equal to approximately $563.0 million, after deducting the Initial Purchasers' discount and offering expenses. BridgeBio used approximately $48.3 million and repurchased shares of its common stock. BridgeBio used approximately $459 million of the net proceeds from the 2031 Notes to repay and terminate the term loan.
• The Company ended the quarter with $540.6 million in cash and cash equivalents, which does not include $105 million in regulatory milestone payments anticipated in Q2 for ex-U.S. approvals of BEYONTTRA.
• Thomas Trimarchi, Ph.D. was appointed President and Chief Financial Officer of the Company.

Financial Updates:

Cash and Cash Equivalents

Cash and cash equivalents totaled $540.6 million as of March 31, 2025, compared to $681.1 million as of December 31, 2024. The $140.5 million net decrease in cash and cash equivalents was primarily attributable to net cash used in operating activities of $199.2 million, repayment of the Company's previous term loan under the credit facility, including prepayment fees, of $459.0 million, and the repurchase of common stock of $48.3 million using proceeds from the 2031 Notes during the three months ended March 31, 2025. These decreases in cash and cash equivalents were partially offset by net proceeds of $563.0 million received from the issuance of the 2031 Notes.

Revenues

Revenues for the three months ended March 31, 2025, were $116.6 million compared to $211.1 million for the same period in the prior year. The $94.5 million decrease in revenues was primarily due to a $131.2 million decrease in license and services revenue, offset by a $36.7 million increase in net product revenue.

License and services revenue

License and services revenue for the three months ended March 31, 2025 was $79.9 million compared to $211.1 million for the same period in the prior year. Revenue recognized during the three months ended March 31, 2025 primarily consists of $75.0 million related to the achievement of the regulatory milestone under the exclusive license and collaboration agreement with Bayer Consumer Care AG (a subsidiary of Bayer AG) ("Bayer”), triggered by the European Commission's approval of BEYONTTRA. A portion of the remaining revenue mainly reflects the incremental service revenue recognized from the non-refundable upfront payments received in 2024 under the exclusive license agreements with Bayer and Kyowa Kirin Co., Ltd ("KKC”). Revenue for the three months ended March 31, 2024, was primarily attributable to the recognition of the majority of the non-refundable upfront payments under the Bayer and the KKC exclusive license agreements.

Net product revenue

Net product revenue for the three months ended March 31, 2025 was $36.7 million and relates to revenue generated from the commercial sale of Attruby in the U.S. following FDA approval in November 2024.

Operating Costs and Expenses

Operating costs and expenses for the three months ended March 31, 2025 were $221.0 million compared to $210.8 million for the same period in the prior year.

Operating costs and expenses increased by $10.2 million for the three months ended March 31, 2025, compared to the same period in the prior year. The increase was primarily driven by a $40.5 million rise in selling, general and administrative expenses ("SG&A”), mainly to support the commercial activities of Attruby. This included higher marketing, advertising, and personnel expenses due to the buildup of BridgeBio's salesforce in the U.S. Additionally, cost of revenues increased by $2.0 million, primarily reflecting the cost of goods sold following the commercial launch of Attruby upon FDA approval in November 2024.

These increases were partially offset by a $29.5 million decrease in research and development expenses ("R&D”), largely due to the divestiture of two early-stage R&D affiliates in 2024, whose expenses are no longer reflected in the current period. The decrease also reflects lower license fees and reduced R&D costs following the FDA approval of Attruby. Restructuring, impairment, and related charges also declined by $2.8 million as we are nearing completion of BridgeBio's restructuring initiatives.

Stock-based compensation expenses included in operating costs and expenses for the three months ended March 31, 2025, were $29.4 million, of which $18.0 million is included in SG&A expenses, $11.3 million is included in R&D expenses, and $0.1 million is included in cost of goods sold. Stock-based compensation expenses included in operating costs and expenses for the same period in the prior year were $28.9 million, of which $16.1 million is included in SG&A expenses and $12.8 million is included in R&D expenses.

Total Other Income (Expense), Net

Total other income (expense), net for the three months ended March 31, 2025, was $65.2 million of other expense, net compared to $36.5 million of other expense, net for the same period in the prior year.

The increase in total other expense, net of $28.7 million for the three months ended March 31, 2025, compared to the same period in the prior year, was primarily due to an increase in interest expense of $18.7 million and a net loss from equity method investments of $15.6 million, partially offset by a decrease in loss on extinguishment of debt of $5.4 million.

Net Loss Attributable to Common Stockholders of BridgeBio and Net Loss per Share

For the three months ended March 31, 2025, the Company recorded a net loss attributable to common stockholders of BridgeBio of $167.4 million, compared to $35.2 million, for the three months ended March 31, 2024.

For the three months ended March 31, 2025, the Company reported a net loss per share of $0.88 compared to $0.20, for the three months ended March 31, 2024.