BridgeBio Pharma, Inc. (BBIO) Q3 2025 Earnings Call Transcript

Access earnings results, analyst expectations, report, slides, earnings call, and transcript.

Overview

The earnings call highlights strong revenue growth, promising product development, and a robust cash position. Despite increased expenses, the company maintains significant cash reserves. The Q&A reveals positive sentiment towards market dynamics and strategic positioning, with growth in patient share and prescriber engagement. Management's confidence in product efficacy and market potential further supports a positive outlook. The market cap indicates a moderate reaction, suggesting a stock price increase in the range of 2% to 8% over the next two weeks.

Key Financial Performance

Total revenues $120.7 million in Q3 2025, consisting of $108.1 million of Attruby net product revenue, $4.3 million of royalty revenue, and $8.3 million of license and services revenue. This represents an increase of $118 million compared to the same period last year, primarily due to the launch and growth of Attruby.

Attruby net product revenue $108.1 million in Q3 2025. This is a significant increase from $0 in the same period last year, driven by strong growth across all market segments.

Royalty revenue $4.3 million in Q3 2025, attributed to ex-U.S. net sales of Beyonttra in Europe and Japan.

License and services revenue $8.3 million in Q3 2025, contributing to the overall revenue growth.

Operating expenses $259.3 million in Q3 2025, compared to $193.9 million in the same period last year. This increase of $65.4 million was primarily driven by a $68.8 million increase in SG&A expenses, partially offset by a slight decline in R&D expenses.

Cash position $645.9 million in cash, cash equivalents, and marketable securities at the end of Q3 2025, providing significant cash runway for the company.

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Operating Highlights

Attruby: Continued strong commercial execution with $108.1 million in net product sales for Q3 2025. Achieved 5,259 unique patient prescriptions and 1,355 unique HCPs. Targeting 30-35% market share by volume in the long term.

BBP-418: Phase III FORTIFY trial in limb-girdle muscular dystrophy type 2i exceeded expectations, meeting all primary and secondary endpoints. Demonstrated significant improvements in ambulatory and pulmonary function.

Encaleret: Phase III CALIBRATE trial in autosomal dominant hypocalcemia type 1 showed profound normalization of blood and urine calcium and PTH levels. Plans to launch and initiate Phase III in chronic hypoparathyroidism.

Infigratinib: Phase III readout for achondroplasia expected in early 2026. Positioned as the first daily oral medication for this condition.

ATTR-CM Market: Continues to expand with increased prescribing from new and returning physicians. Attruby positioned as the least expensive option in the market, supporting long-term competitiveness.

Global Expansion: Beyonttra gaining traction in Europe with nearly 50% NBRx in Germany within 6 months of launch. Infrastructure being built for global commercialization of pipeline products.

R&D Productivity: Achieved industry-leading timelines and high probability of technical success (over 70%) for programs. Decentralized hub-and-spoke model credited for efficiency.

Financial Position: Strong cash position of $645.9 million as of Q3 2025, supporting transition into a diversified late-stage multiproduct business.

Pipeline Growth: Expanding portfolio with 17 programs at GondolaBio, including promising assets in EPP, alpha-1 antitrypsin deficiency, and hereditary pancreatitis.

Commercial Strategy: Leveraging learnings from Attruby launch to prepare for upcoming launches of encaleret, BBP-418, and infigratinib. Focus on disease awareness, HCP engagement, and patient access strategies.

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Risk or Challenges

Market competition: The company faces competitive pressures in the ATTR-CM market, particularly from existing players like Pfizer. While Attruby has shown strong performance, competition remains a challenge, especially as competitors may make claims about their products that could influence market perception.

Regulatory hurdles: The company highlighted regulatory challenges, such as the need to address inaccurate claims by competitors in Europe. This indicates potential regulatory scrutiny and the need for compliance in different markets.

Supply chain and commercialization risks: Scaling rare disease commercialization, particularly for upcoming launches like encaleret and BBP-418, poses challenges. Building disease awareness, engaging healthcare provider networks, and ensuring patient access require significant operational effort and resources.

Economic uncertainties: The U.S. healthcare environment is becoming increasingly cost-conscious, which could impact pricing and access for Attruby and other products. This creates financial risks in maintaining competitiveness.

Strategic execution risks: The company is expanding its global footprint and preparing for multiple product launches, which involves hiring, infrastructure development, and market access strategies. These activities carry execution risks, especially in ensuring timely and effective implementation.

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Guidance & Outlook

Market Share Goal for Attruby: BridgeBio aims to achieve a 30-plus percent market share by volume for Attruby in the coming years, with potential to become a market leader.

Phase III FORTIFY Trial of BBP-418: The trial for limb-girdle muscular dystrophy type 2i exceeded expectations, meeting all primary and secondary endpoints. The drug showed significant improvements in muscle function and pulmonary function, with a safe profile. Additional data on its impact on other tissues, including the heart, will be shared.

Phase III CALIBRATE Trial of Encaleret: The trial for autosomal dominant hypocalcemia type 1 showed profound normalization of blood and urine calcium and PTH levels. The drug is being prepared for launch and a Phase III trial in chronic hypoparathyroidism.

Attruby's Market Expansion: Attruby continues to grow in the ATTR-CM market, with increasing adoption by new and returning physicians. The drug is positioned as the least expensive option in the market, supporting long-term competitiveness.

Future Growth Opportunities: BridgeBio is focusing on expansion programs for hypochondroplasia and chronic hypoparathyroidism, as well as leveraging its sister company GondolaBio's 17 programs in the Mendelian landscape.

Upcoming Launches: BridgeBio is preparing for the launches of encaleret, BBP-418, and infigratinib, with commercial leadership and infrastructure already being established. Infigratinib is expected to read out in early 2026.

Global Commercialization: The company is building infrastructure for global commercialization to support coordinated launches and sustained access for its therapies.

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Shareholder Return Plan

The selected topic was not discussed during the call.

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Key Q&A

Q:What is the current percentage of new patient share for the company, and how has it changed since the last quarter?

A:The naive share is estimated to be well in the 20s now, up from 18%-20% in the previous quarter. There has been double-digit growth in overall script quarter-on-quarter, with significant growth in the NBRx setting.

Q:What are the trends in ATTR cardiomyopathy diagnosis rates and the impact of market dynamics like AMVUTTRA's higher ASP?

A:Diagnosis rates have shown robust growth compared to the same quarter last year, with new practices and doctors finding more patients. The higher ASP of AMVUTTRA is not seen as a significant factor affecting the market, as most cardiologists focus on data efficacy, safety, and cost rather than profit from buy-and-bill dynamics.

Q:What is the company's view on Pfizer's 28-day free trial program for VYNDAMAX?

A:The company views Pfizer's 28-day free trial program as a positive development and believes it aligns with their own generous patient programs. They do not see it as having a significant impact on their market share.

Q:What is the size of the OUS (outside the U.S.) opportunity for ATTR, and how does it compare to the U.S. market?

A:The OUS opportunity is significant, with Bayer performing well in commercialized countries. However, price points in Europe are lower than in the U.S. The company expects the sales ratio between Europe and the U.S. to be similar to what is seen in TAF.

Q:Have there been discussions with payers about formulary positioning of Attruby when TAF generics enter the market or about combination therapy?

A:No discussions have been held with payers about formulary positioning of Attruby when TAF generics enter the market or about combination therapy. The company expects payers to control the category more in the future but not within the next 6-12 months.

Q:What is driving the growth in unique prescribers and prescriptions per prescriber for Attruby?

A:Growth is driven by both greater penetration within existing accounts and expansion into new centers. The company has also targeted ancillary or satellite practices and employed IT techniques to identify new prescribers.

Q:What is the marketing message for Attruby regarding patients with mixed phenotype?

A:The focus is on cardiomyopathy as the primary driver of mortality and morbidity. The company emphasizes its differentiated binding profile and superior efficacy in the variant population, supported by a 59% hazard reduction in this group.

Q:What are the company's plans for early-stage and mid-stage pipeline investments?

A:The company is focused on executing its current launches but sees significant opportunities in rare and orphan diseases due to scientific advancements. They are exploring partnerships and acquisitions to expand their pipeline.

Q:What are the company's thoughts on conducting a head-to-head study for Attruby against tafamidis?

A:The company believes it has already demonstrated superior efficacy through various measures and does not see a head-to-head study as necessary or impactful for market share. They are focusing on real-world evidence to differentiate their product.

Q:What are the differentiating elements for infigratinib in achondroplasia, and how does the company view its market potential?

A:Infigratinib is seen as more efficacious, safer, and more convenient (oral route of administration) compared to competitors. The company believes it can address unmet needs and expand the market, with a potential TAM of $2 billion each for achondroplasia and hypochondroplasia.

Q:What gives the company confidence in encaleret as a $1 billion-plus product?

A:The company cites a large treatable population (up to 12,000 in the U.S.), high efficacy (76% normalization rate), and a safer profile compared to standard care. They believe the drug addresses significant unmet needs and can achieve substantial market penetration.

Q:Review of Unclear Management Responses

A:Management avoided giving direct answers to questions about the impact of TAF generics on Attruby's formulary positioning and the potential for combination therapy. They also did not provide quantitative breakdowns for growth drivers in unique prescribers and prescriptions per prescriber, and their comments on the OUS opportunity lacked specific numerical details.

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Earnings Word Cloud

The most frequently occurring keywords in this quarter's earning call

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The earnings call highlights strong financial performance, positive product development updates, and strategic market positioning, with a focus on clinical efficacy and market expansion. The Q&A section further emphasizes growth potential and competitive advantages, despite some management ambiguity on inventory specifics. The overall sentiment is positive, with optimistic guidance and strategic initiatives likely driving stock price upwards.

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