BridgeBio Pharma, Inc. (BBIO) Q2 2025 Earnings Call Transcript

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

Overview

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.

Key Financial Performance

Attruby global sales $78 million in Q2 2025, representing approximately 100% revenue growth year-over-year. This growth is attributed to the strong and accelerating launch of Attruby, with increased patient prescriptions and prescribers.

Attruby U.S. net sales $71.5 million in Q2 2025, also reflecting 100% growth over the previous quarter. The growth is driven by momentum in treatment-naive patients and an increasing number of prescribers.

Total revenues $110.6 million in Q2 2025, up from $2.2 million in the same period last year. The increase is primarily due to $71.5 million in net product revenue from Attruby and $35.3 million in license and services revenue.

Operating costs and expenses $244.8 million in Q2 2025, compared to $177.7 million in the same period last year. The increase of $67.1 million is primarily driven by a $69.6 million increase in SG&A expenses, partially offset by a $3.5 million decline in R&D expenses.

Stock-based compensation expense $37.7 million in Q2 2025, up from $21.5 million in Q2 2024. This reflects ongoing investments in the Attruby brand and late-stage clinical programs.

Cash position $756.9 million at the end of Q2 2025, bolstered by proceeds from the strategic monetization of BEYONTTRA European royalties for $300 million and strong Attruby sales.

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Operating Highlights

Attruby launch: Strong and accelerating launch with 3,751 unique patient prescriptions and 1,074 unique prescribers. Weekly scripts grew by over 30%, leading to $78 million in global sales and $71.5 million in U.S. net sales in Q2 2025. Attruby is positively impacting thousands of patients and has the most generous access programs in the space.

Clinical research on Attruby: Published 3 results, including subpopulation analyses and scientific underpinnings of the disease. Demonstrated significant benefits in variant subtypes and cardiac arrhythmic involvement, with reductions in risk of CVH and AFib.

ATTR-CM market expansion: ATTR-CM category is rapidly growing, expected to reach $15-$20 billion at peak. Attruby is capturing share in treatment-naive patients and is expected to achieve 30%-40% peak market share.

Revenue growth: Total revenues reached $110.6 million in Q2 2025, driven by $71.5 million in Attruby net product revenue and $30 million regulatory milestone from BEYONTTRA pricing approval in Japan.

Financial position: Strong cash position of $756.9 million, supported by strategic monetization of BEYONTTRA European royalties for $300 million and Attruby sales.

Pipeline diversification: BridgeBio is transitioning to a diversified biopharma company with 3 late-stage assets (ADH1, LGMD2I, achondroplasia) expected to launch in 2026-2027, each with $1 billion+ peak sales potential.

Future launches: Attruby's success has built a strong commercial infrastructure to support future rare disease launches, with each new launch expected to exceed $1 billion in U.S. peak sales.

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Risk or Challenges

Market Competition: The ATTR cardiomyopathy market now has three players, increasing competitive pressures. This could impact market share and pricing strategies for Attruby.

Regulatory and Reimbursement Risks: Attruby's success is partly due to favorable IRA policies and generous access programs. Changes in these policies or reimbursement structures could negatively impact patient affordability and sales.

Pipeline and R&D Uncertainty: The company is heavily reliant on the success of its late-stage pipeline, including three Phase III trials. Any failure or delay in these trials could significantly impact future growth and diversification plans.

Operational Costs: Operating costs and expenses increased by $67.1 million year-over-year, driven by SG&A expenses. Sustained high costs could pressure profitability, especially if revenue growth slows.

Supply Chain and Inventory Management: Attruby's just-in-time supply model requires precise execution. Any disruptions could impact product availability and sales.

Market Expansion Challenges: The company aims to expand its market share in treatment-naive populations and underdiagnosed conditions. Achieving this requires significant educational and awareness efforts, which may not yield immediate results.

Economic and Financial Risks: The company relies on a strong cash position and recent monetization of royalties. Any economic downturn or financial mismanagement could strain resources and impact operations.

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Guidance & Outlook

Attruby Revenue Growth: Attruby achieved $71.5 million in net product revenue in Q2 2025, representing 100% growth over Q1. The ATTR-CM market is expected to reach $15 billion to $20 billion at peak, providing significant growth potential for Attruby.

ATTR-CM Market Expansion: The ATTR-CM category is expanding rapidly, with expectations to reach $15 billion to $20 billion at peak. This growth provides a strong tailwind for Attruby's continued success.

Future Product Launches: BridgeBio anticipates three additional product launches in 2026 and 2027, each with peak sales potential exceeding $1 billion in the U.S. market alone. These launches will leverage the commercial infrastructure established by Attruby.

ADH1 Phase III Trial: Results for the Phase III trial of a negative allosteric modulator for ADH1 are expected in fall 2025. The drug aims to normalize urinary and serum calcium levels, with potential response rates of 50% or greater.

LGMD2I Phase III Trial: Phase III trial results for Limb-Girdle Muscular Dystrophy Type 2i are anticipated in fall 2025. The drug targets this condition at its source with a small molecule approach.

Achondroplasia Phase III Trial: Phase III trial results for achondroplasia are expected in early 2026. The drug aims to address this high unmet need condition.

Encouraging Data for Encaleret: Encaleret has shown promise in chronic hypoparathyroidism, normalizing urine and serum calcium levels in 80% of patients within 5 days of dosing. This drug could address unmet needs in hypoparathyroidism with its oral administration and potential to avoid kidney and bone issues.

ACT-EARLY Trial for Attruby: The ACT-EARLY trial aims to extend the use of Attruby beyond the acute phase of ATTR-CM to potential prevention. This trial reinforces the importance of early disease detection and treatment.

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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 driving the faster patient add numbers and how might this change in the third and fourth quarters?

A:The faster patient add numbers are driven by strength in treatment-naive starts, continued switch activity, increased screening, and awareness. Unique patient starts and prescriber counts are increasing. The Attruby profile resonates with both patients and doctors due to benefits like a 50% reduction in hospitalization rates. The market is expanding, and BridgeBio is becoming the partner of choice for healthcare professionals. The NBRx share is estimated to be 18%-20% and growing healthily. Factors like better access, increasing scientific share of voice, and new data (e.g., serum TTR paper) are also contributing to momentum.

Q:How have the 28-day free trial, patient assistance programs, and gross-to-net trends evolved in the second quarter compared to the first quarter?

A:These components have normalized in the second quarter. The company emphasizes the importance of serving underpenetrated populations with ATTR cardiomyopathy. Generous access programs and pricing are seen as long-term strategies to maintain market share and support underserved communities. Gross profit margins are expected to stay normalized over time.

Q:What is the community versus academic market share for Attruby, and how is the pipeline positioned for infigratinib and hypochondroplasia?

A:The majority of Attruby's market share is in COE or COE-capitated practices, but there is a pickup in the community due to increased awareness. For infigratinib, the focus is on providing a daily oral treatment option with deeper efficacy by targeting the MAPK pathway and STAT1. Market research suggests an oral treatment could capture 60% of the market. Recent data shows infigratinib has potential for similar efficacy in hypochondroplasia as in achondroplasia.

Q:What would be considered a meaningful win in the upcoming Phase III CALIBRATE trial for encaleret?

A:A meaningful win would be achieving concomitant normalization of blood and urine calcium, which are critical biomarkers for the condition. In Phase II, 69% of participants achieved this on encaleret compared to 0% on standard care. A majority of patients achieving these criteria in Phase III would be seen as clinically meaningful and statistically significant.

Q:What are the key efficacy and biomarker thresholds for potential approval of limb-girdle MD2I based on upcoming interim data?

A:Key thresholds include a robust effect on glycosylated alpha-dystroglycan (5% or more elevation), a 40% or more reduction in CK, trends in functional endpoints (statistical significance not required), and a well-tolerated safety profile. These would support regulatory approval on an accelerated basis.

Q:What are the competitive dynamics in the multipayer market for ATTR therapies?

A:Competition is more intense in the switch category, with Alnylam and Pfizer being key competitors. Alnylam is more active in the switch category, while Pfizer is more competitive in the treatment-naive population. There is no significant race to the bottom in pricing or contracting. Clinical differentiation and efficacy are the primary competitive factors.

Q:What areas for growth have been identified for Attruby, and what is BridgeBio excited about for the remainder of the year?

A:Growth areas include continued clinical and efficacy differentiation, early impact and efficacy, and improving access. BridgeBio is excited about publishing more data on early action, real-world evidence, and health economic parameters. They are also focused on making Attruby easily accessible to patients and physicians.

Q:What is driving prescribing growth for Attruby, and where is the most growth occurring?

A:Prescribing growth is driven by the efficacy of Attruby, positive patient and HCP experiences, and support programs. Growth is occurring in both academic and community centers, with HCPs continuing to prescribe more after seeing positive results.

Q:What is the potential for encaleret in hypoparathyroidism, and how does it compare to existing therapies?

A:Encalaeret shows promise for hypoparathyroidism, with rapid and durable normalization of blood and urine calcium. In a Sentinel study, 80% of participants normalized these levels within 5 days. Encalaeret could differentiate by being oral, reducing urinary calcium excretion, and avoiding long-term bone resorptive effects seen with PTH replacement therapy.

Q:How is BridgeBio leveraging data to promote Attruby in the first-line setting, and what additional data is expected in the next 12-24 months?

A:BridgeBio is leveraging data through publications, conferences, and real-world evidence studies. They are focusing on clinical differentiation, rapidity of response, and health economic parameters. Upcoming data will include real-world evidence on biomarkers like NT-proBNP and troponin, quality of life, hospitalization measures, and health economic outcomes.

Q:Review of Unclear Management Responses

A:Management avoided providing a direct answer to the question about inventory changes in Q2 relative to Q1. While they mentioned that held inventory was lower in Q2 due to a just-in-time model, they did not provide specific numerical details or a clear comparison.

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Earnings Word Cloud

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

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