• Total Revenue: $116.6 million for Q1 2025.
• Attruby Net Product Revenue: $36.7 million.
• License and Services Revenue: $79.9 million, primarily from BEYONTTRA's EU approval.
• Total Operating Expenses: $218.4 million, up from $210.2 million in the same period last year.
• Stock-Based Compensation Expense: $29.4 million, compared to $28.9 million in Q1 2024.
• R&D Expense: $111.4 million, down from $141 million in the same period last year.
• SG&A Expense: $106.4 million, up from $65.8 million in the same period last year.
• Restructuring Expense: $0.6 million, compared to $3.4 million in the same period last year.
• Cash and Cash Equivalents: $540.6 million at the end of the quarter.

• Warning! GuruFocus has detected 6 Warning Signs with BBIO.

Release Date: April 29, 2025

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Positive Points

• BridgeBio Pharma Inc (NASDAQ:BBIO) reported strong revenue of $36.7 million from the launch of Attruby, indicating positive market reception.
• Attruby demonstrated a 42% relative risk reduction in cardiovascular hospitalization and mortality at 30 months, with a 50% reduction in cardiovascular hospitalization.
• The company has a robust pipeline with three Phase III readouts expected in the next year, including efforts in chronic hypoparathyroidism.
• BridgeBio Pharma Inc (NASDAQ:BBIO) has a strong financial position with $540.6 million in cash and cash equivalents, excluding anticipated regulatory milestone payments.
• The company is expanding its market presence with the rapid enrollment of trials and positive progress in key additional markets, such as hypochondroplasia.

Negative Points

• Operating expenses increased to $218.4 million in Q1 2025, reflecting continued investment in the Attruby brand and late-stage pipeline.
• SG&A expenses rose significantly to $106.4 million, driven by the commercial rollout of Attruby.
• The company faces competition in the ATTR-CM market, with new entrants potentially impacting market share.
• There is uncertainty regarding the long-term sustainability of current growth rates, particularly in the face of potential market saturation.
• The company acknowledges potential risks and uncertainties that could cause actual results to differ materially from forward-looking statements.

Q & A Highlights

Q: Can you provide more details on the tailwinds that contributed to the strong quarter? A: Neil Kumar, CEO, explained that the demand is primarily driven by the differentiated clinical efficacy of Attruby, which shows early separation and a 42% relative risk reduction at 30 months. Additionally, market growth and effective access programs have been significant contributors. The company is also the only sponsor offering free drugs for life to trial participants, which has positively impacted their reputation among physicians.

Q: Can you quantify the paid conversion rate for Attruby sales? A: Matthew Outten, Chief Commercial Officer, stated that conversion rates from free trial to paid prescriptions are tracking well, consistent or better than historical launches. The distribution network is designed for easy access, with distributors holding about one to two weeks of inventory, indicating demand-driven sales.

Q: How is the Limb-Girdle Muscular Dystrophy (LGMD) program progressing, and are there concerns about FDA approval based on biomarkers? A: Neil Kumar, CEO, expressed confidence in the LGMD program, noting positive interactions with the FDA and the likelihood of approval based on glycosylation of [ADG]. The company expects positive clinical outcomes based on Phase II data and is running a confirmatory trial to support approval.

Q: What are the expectations for the ADH1 and LGMD Phase III trials, and why should investors be excited? A: Neil Kumar highlighted the significant market potential for both ADH1 and LGMD, with large patient populations and first-in-class treatment opportunities. The achondroplasia program also presents a promising market, with potential best-in-class oral treatment options.

Q: What is resonating with healthcare professionals regarding the Attruby launch, and what are the biggest hurdles? A: Matthew Outten noted that the strong clinical data, including early efficacy and impact on hospitalization rates, are resonating well with physicians. The biggest hurdles include ensuring patients can access the medication easily, which the company is addressing through robust patient support programs.

Q: How is the market growth for ATTR-CM expected to evolve, and what is driving new patient starts? A: Neil Kumar explained that the market is growing due to increased awareness and education, with more companies launching products. The company expects continued high numbers of new diagnoses, driven by increased screening and education efforts.

Q: How does the company view the impact of tariffs and royalties on its financials? A: Thomas Trimarchi, COO, stated that the impact of tariffs is minimal due to the U.S.-based manufacturing and IP domicile. Royalties from ex-U.S. partners are accounted for in the top-line revenue, with no significant tariff implications expected.

Q: What excites you about the chronic hypoparathyroidism indication for Encaleret? A: Neil Kumar and Ananth Sridhar highlighted the large market opportunity, significantly larger than ADH1, and the potential for Encaleret to be a paradigm-changing treatment. The company is advancing towards registration for this indication.

For the complete transcript of the earnings call, please refer to the full earnings call transcript.