Blueprint Medicines Corporation (BPMC): PESTLE Analysis [Nov-2025 Updated]

You need to know exactly where Blueprint Medicines Corporation (BPMC) stands as 2025 unfolds, because the external environment is changing faster than ever, and its future isn't just about the science. Precision oncology is a high-stakes game, where everything from the US Inflation Reduction Act (IRA) to global supply chain stability will dictate success. We've mapped the Political, Economic, Sociological, Technological, Legal, and Environmental forces-the PESTLE factors-that will truly dictate if BPMC can hit its projected 2025 Ayvakit net product revenue of $450 million to $480 million. Get a clear view of the near-term risks and opportunities that matter most for BPMC's valuation.

Blueprint Medicines Corporation (BPMC) - PESTLE Analysis: Political factors

US Inflation Reduction Act (IRA) price negotiation risk for high-cost oncology drugs starting in 2026.

The US Inflation Reduction Act (IRA) of 2022 fundamentally shifted the political landscape for high-cost drugs, and this is a near-term risk for Blueprint Medicines Corporation, especially now under the Sanofi umbrella. The IRA empowers Medicare to negotiate prices for certain high-cost, single-source drugs, with the first negotiated prices taking effect in 2026.

Here's the quick math: Small-molecule drugs, like BPMC's flagship product Ayvakit (avapritinib), become eligible for negotiation after nine years on the market. Ayvakit was first approved in January 2020 for GIST, so it is safe from the initial 2026 and 2027 negotiation cycles. But the long-term risk is real, so you need to look past 2028.

The most immediate political risk for Ayvakit is its multiple-indication status. The IRA grants an exemption for drugs with a single orphan disease indication, but Ayvakit is approved for multiple indications, including gastrointestinal stromal tumors (GIST), advanced systemic mastocytosis (SM), and indolent systemic mastocytosis (ISM). Because it has more than one approved use, it is not eligible for the single orphan drug exemption and is a clear future target once it hits the nine-year mark.

Faster FDA and EMA approval pathways for breakthrough therapies in rare diseases.

The political will in both the US and Europe to accelerate drug approvals for rare diseases is a major opportunity for BPMC's pipeline. The company focuses on precision oncology and rare immunological disorders like systemic mastocytosis (SM), and these pathways can shave years off development time.

The European Medicines Agency (EMA) has streamlined its accelerated assessment pathways to cut approval times from a standard 210 days to as few as 90 days for qualifying medications. In the US, leveraging the FDA's Accelerated Approval pathway for rare diseases could reduce development costs by approximately 60%, according to one study. This is a massive tailwind for a biotech portfolio like BPMC's.

This opportunity is concretely reflected in the Sanofi acquisition of BPMC, announced in June 2025 for approximately $9.5 billion. Part of the deal's value is tied to a Contingent Value Right (CVR) of up to $6 per share for shareholders, which is contingent on the successful and rapid development of the pipeline candidate BLU-808. This CVR structure is a direct financial bet on BPMC's ability to capitalize on these faster regulatory pathways, especially for a drug like BLU-808, a wild-type KIT inhibitor in Phase 2a studies for immunology indications.

• Accelerate time-to-market for pipeline candidates like elenestinib and BLU-808.
• Reduce overall clinical development costs by an estimated 60% via Accelerated Approval.
• EMA fast-track can cut review time from 210 days to 90 days for priority drugs.

Geopolitical risk impacting global supply chains for active pharmaceutical ingredients (APIs).

The concentration of Active Pharmaceutical Ingredient (API) and precursor production in a few key Asian countries, primarily China and India, has become a major geopolitical risk in 2025. This vulnerability is a direct political concern, as trade disputes and national security concerns can instantly disrupt the supply of BPMC's oral small-molecule drugs.

The US government has imposed tariffs on pharmaceutical imports, including up to 25% duties on certain Chinese APIs and up to 20% on certain Indian APIs. For a company like BPMC, which relies on a complex global supply chain for its commercial product, Ayvakit, these tariffs translate directly into higher input costs. Some pharmaceutical firms have already reported API cost increases of 12-20% due to these trade restrictions and the push for supply chain diversification.

This means BPMC, or its new parent Sanofi, must invest heavily in a 'China+1' or 'India+1' strategy-a political imperative to diversify sourcing to other regions or even on-shore production, which is expensive and complex. This is defintely a cost pressure that will weigh on the gross margin of the Ayvakit franchise, which is expected to generate approximately $700 million to $720 million in global net product revenue in 2025.

Increased regulatory scrutiny on clinical trial diversity and patient recruitment protocols.

The political push for health equity has translated into new, mandatory clinical trial regulations. The Food and Drug Omnibus Reform Act (FDORA) of 2022 mandates that sponsors of Phase 3 or pivotal studies for drugs and biologics must submit a Diversity Action Plan (DAP).

The final FDA guidance on the DAP was expected around mid-2025, and the requirements will apply to new qualifying studies enrolling 180 days after that final guidance. For BPMC, which has multiple ongoing and planned pivotal trials, including the HARBOR study for elenestinib in indolent systemic mastocytosis, this new mandate creates operational complexity and cost.

The DAP must outline concrete strategies to enroll and retain participants from underrepresented racial and ethnic groups, which often requires new site selection, community engagement, and patient support infrastructure. Failing to meet diversity targets can lead to regulatory delays, which is the last thing you want when trying to commercialize a $9.5 billion asset portfolio. This means BPMC must be proactive in engaging with underutilized trial sites and local communities to ensure their data is generalizable to the real-world patient population.

Blueprint Medicines Corporation (BPMC) - PESTLE Analysis: Economic factors

The economic environment for Blueprint Medicines Corporation (BPMC) in 2025 is a study in contrasts: strong commercial performance for its lead drug, Ayvakit (avapritinib), is running head-on into a global macro-economic reality of tight credit and aggressive healthcare cost containment. The company is, however, building a war chest of cash that provides a significant buffer.

Projected 2025 Ayvakit net product revenue is expected to be in the range of $700 million to $720 million, driving core growth.

The core of BPMC's economic strength is the commercial success of Ayvakit in treating systemic mastocytosis (SM). Following a strong start to the year, the company raised its full-year 2025 global net product revenue guidance for Ayvakit to a range of $700 million to $720 million. This represents a substantial increase from the initial estimates, showing the growing market penetration, especially in the US. The first quarter of 2025 alone saw Ayvakit net product revenues hit $149.4 million, with the US market contributing the vast majority at $129.4 million.

Here's the quick math: Hitting the midpoint of the guidance, $710 million, means the company needs to generate an average of approximately $186.87 million in revenue per quarter for the remaining three quarters of 2025. That's a big jump, but it's supported by growing patient interest and market expansion.

Continued pressure on global healthcare systems to reduce costs, impacting reimbursement rates.

Despite strong US sales, the global market for high-cost specialty drugs is getting tougher. Governments and payers are pushing hard on price, which directly impacts reimbursement (the payment a health plan makes for a medical service or drug). In the US, the Inflation Reduction Act (IRA) is a massive headwind, empowering Medicare to negotiate prices on certain high-expenditure drugs, with the first negotiated prices taking effect in early 2026.

In Europe, the implementation of the new EU Health Technology Assessment (HTA) legislation, which began on January 12, 2025, for oncology and advanced therapies, adds complexity to market access. BPMC is actively navigating this, with a 2025 goal to achieve reimbursement for Ayvakit in $\geq$ 20 countries overall. The push for joint negotiation and real-world evidence is a new hurdle for market access teams to clear.

High interest rates and tighter credit markets challenging capital raising for smaller biotechs.

The general biotech funding environment remains challenging. While BPMC is relatively insulated due to its commercial product revenue and strong cash position, the cost of capital for the industry is high. The Federal Reserve lowered the Federal Funds Rate target range to 3.75%-4.00% in October 2025, but this is still a high-rate environment compared to the near-zero rates of the past decade.

This macro-trend affects smaller, pre-commercial biotechs more severely, but it still influences BPMC's debt financing costs. The company's net interest expense was $8.129 million in Q1 2025, up from $5.895 million in the same quarter last year, reflecting the higher cost of servicing its debt. The good news is that BPMC reported a robust cash, cash equivalents, and investments balance of $899.8 million as of March 31, 2025, which gives them a long runway to reach a self-sustainable financial profile.

Strong US dollar potentially reducing the value of ex-US Ayvakit sales.

Currency risk is a factor, especially as BPMC expands its global footprint. A strong US dollar means that revenue generated in foreign currencies (like the Euro or Yen) translates into fewer US dollars when reported on the income statement. While the US market is dominant, accounting for $129.4 million of Q1 2025 revenue, the ex-US sales of $20 million are subject to this currency translation risk.

The company is aiming to secure reimbursement in more than 20 countries, which will increase the proportion of foreign-denominated revenue and, in turn, increase the exposure to foreign exchange (FX) volatility. This is a risk that requires careful hedging (a financial strategy to offset potential losses). One clean line: FX volatility is the silent tax on international sales.

The economic outlook is defintely strong on the top line, but the bottom line still faces macro-pressures from interest rates and global reimbursement hurdles. Your next step should be to model the impact of a 5% currency fluctuation on the ex-US revenue component of the $700 million to $720 million guidance.

Blueprint Medicines Corporation (BPMC) - PESTLE Analysis: Social factors

Growing patient and physician demand for targeted, precision oncology treatments

The social shift toward personalized medicine (precision oncology) is a massive tailwind for Blueprint Medicines Corporation. Patients and physicians are defintely moving away from the old one-size-fits-all chemotherapy models, demanding treatments that target the root cause of their disease, like the KIT D816V mutation addressed by AYVAKIT (avapritinib). This demand is evident in the market size alone: the global oncology precision medicine market is estimated to be valued at $\mathbf{USD 153.81}$ billion in 2025.

For BPMC's core franchise in Systemic Mastocytosis (SM), this social awareness is translating directly into patient identification and revenue. Over the last five years, the number of diagnosed SM patients observable in U.S. claims data has grown at a compound annual growth rate of $\mathbf{25}$ percent, with more than $\mathbf{25,000}$ diagnosed patients in the U.S. today. This growth is a direct result of increased disease awareness and the availability of a targeted therapy. Your strategy here must focus on maintaining this educational and diagnostic momentum.

Increased public scrutiny on drug pricing and access, especially for rare diseases

Honest to goodness, the high price of specialty drugs, particularly for rare diseases, is a major social and political flashpoint. While the median annual list price for a new drug was over $\mathbf{\$370,000}$ in 2024, BPMC's flagship product, AYVAKIT, has a list price (Wholesale Acquisition Cost, or WAC) of $\mathbf{\$40,837}$ for all doses and package sizes as of January 2025. This price point puts BPMC squarely in the spotlight, even with its life-changing efficacy.

To mitigate this scrutiny and ensure patient access-which is a social imperative-BPMC employs a comprehensive patient support system, YourBlueprint. This program is the company's direct answer to the affordability problem. The quick math on access shows a strong defense against public criticism:

The company also plans to achieve reimbursement of AYVAKIT in at least $\mathbf{20}$ countries overall by the end of 2025, which is a key social metric for global responsibility and access.

Focus on health equity requiring broader inclusion in clinical trials

The push for health equity is a non-negotiable social factor for all biopharma companies in 2025. Failure to ensure diverse representation in clinical trials is not just bad ethics; it creates an incomplete dataset that limits a drug's market utility across diverse patient populations. Honestly, the industry has a lot of work to do.

The disparity data is stark and creates a clear risk for BPMC's future programs, like the Phase 3 HARBOR trial for elenestinib. For instance, the African American population comprises only $\mathbf{6\%}$ of therapeutic cancer clinical trial participants, but their cancer prevalence is $\mathbf{10\%}$. Similarly, the Hispanic population makes up only $\mathbf{3\%}$ of participants despite a $\mathbf{7\%}$ cancer prevalence. Only an estimated $\mathbf{3\%}$-$\mathbf{5\%}$ of adult cancer patients participate in U.S. trials at all.

Your action here is to embed diversity into trial design from the start. BPMC has publicly stated a commitment to Equity, Diversity, and Inclusion (ED&I), and this must translate to:

• Partnering with community oncology centers to reach underserved populations.
• Designing decentralized trials to remove geographic and logistical barriers.
• Ensuring patient-facing materials are culturally and linguistically appropriate.

What this estimate hides is the potential for different ethnic groups to metabolize or respond to kinase inhibitors differently; you need to know this before launch.

High-profile success stories of targeted therapies raising patient expectations

The success of precision therapies like AYVAKIT in treating the root cause of disease, rather than just managing symptoms, has fundamentally reset patient expectations. This success is now the new baseline for any novel therapy in oncology or rare disease.

BPMC itself is a high-profile success story, which means the pressure is on for its pipeline. AYVAKIT is one of the most successful rare disease launches to date, anchoring a Systemic Mastocytosis franchise that BPMC estimates has a peak revenue opportunity of $\mathbf{\$4}$ billion, with $\mathbf{\$2}$ billion in annual revenues expected to be achieved by AYVAKIT by 2030. The 2025 global net product revenue guidance of $\mathbf{\$700}$ million to $\mathbf{\$720}$ million is the proof point that patients are getting better results and expecting more.

This success raises the bar for BPMC's next-generation programs, like elenestinib and BLU-808. Patients now expect:

• A high confirmed overall response rate (ORR), like the $\mathbf{95}$ percent achieved in treatment-naïve advanced SM patients in the PATHFINDER trial of AYVAKIT.
• Durable response and prolonged survival benefits.
• A favorable safety profile that supports long-term, chronic treatment.

The market is no longer satisfied with marginal gains; they want disease-modifying therapies.

Blueprint Medicines Corporation (BPMC) - PESTLE Analysis: Technological factors

You need to understand that technology, for a precision oncology company like Blueprint Medicines Corporation, isn't just about the drug itself; it's about the entire ecosystem of diagnostics, data science, and manufacturing that makes the targeted drug viable. The technological landscape in 2025 presents both a clear path for their targeted kinase inhibitors and a longer-term competitive threat from novel, complex modalities.

Advancements in companion diagnostics (CDx) crucial for identifying eligible patient populations

Blueprint Medicines' entire business model, centered on precision therapy, relies heavily on technological advancements in companion diagnostics (CDx). A CDx is a test that identifies patients most likely to benefit from a specific drug by detecting a particular biomarker, like a gene mutation.

For their anchor product, Ayvakit (avapritinib), the target is the KIT D816V mutation in systemic mastocytosis (SM). The ability to accurately and widely screen for this mutation is a primary driver of market growth. In 2025, the company raised its full-year guidance for AYVAKIT net product revenue to between $700 million and $720 million, a figure underpinned by the increasing diagnosis rates and prescriber base expansion. This revenue growth directly correlates with the technological success of the diagnostic tools. The company's strategy involves continuous investment in these tools to improve patient stratification in clinical trials and enhance the overall understanding of disease biology.

Pipeline focus on next-generation inhibitors like BLU-222 (CDK2 inhibitor) showing promising Phase 1/2 data

While Blueprint Medicines has demonstrated early technological success with its next-generation inhibitors, a strategic pivot in 2025 highlights the high-stakes nature of this R&D. The company's CDK2 inhibitor, BLU-222, showed promising Phase 1 data in combination with other drugs for hormone-receptor-positive/HER2-negative breast cancer.

Specifically, the data showed compelling reductions in biomarkers like thymidine kinase 1 (TK1) and circulating tumor DNA (ctDNA), which are predictive of clinical benefit. However, in January 2025, Blueprint Medicines announced it would de-prioritize further investment in the BLU-222 program after completing the Phase 1 dose escalation. This decision, despite the positive early data, signals a strategic shift to focus resources on other, potentially more differentiated, next-generation programs, including targeted protein degraders, or to seek a partner to advance BLU-222.

Competition from novel modalities, including cell and gene therapies, in the oncology space

The core technology of Blueprint Medicines is small-molecule kinase inhibition, which faces competition not only from rival tyrosine kinase inhibitors (TKIs) but also from revolutionary novel modalities. Cell and gene therapies (CGTs), such as CAR T-cell therapy, are reaching an inflection point in 2025, with oncologists reporting an increase in the average number of patients treated, rising from 17 to 25.1.

While CGTs are currently challenged by reimbursement, infrastructure, and complex manufacturing-the global CGT manufacturing market is still projected to soar to approximately $97.33 billion by 2033-their long-term, potentially curative nature poses a significant technological threat to chronic TKI treatments. The competition is already direct in some areas; for instance, rival companies are advancing next-generation KIT inhibitors, like Cogent's bezuclastinib, which is directly competing with Ayvakit in systemic mastocytosis and gastrointestinal stromal tumors (GIST).

Here's the quick math: A single, curative CGT could displace years of chronic TKI revenue, so the threat is real, defintely.

Increased use of AI and machine learning to accelerate drug discovery and trial design

Blueprint Medicines is actively incorporating advanced computational tools into its R&D framework. The company has integrated technologies like artificial intelligence (AI) and machine learning (ML) to enhance its core kinase inhibition research platform and new modalities like targeted protein degradation.

The industry trend in 2025 shows AI platforms leveraging deep learning and generative models to predict molecular interactions and optimize drug candidates, which is helping to dramatically reduce R&D timelines, sometimes by as much as 50%. For Blueprint Medicines, this means:

• Faster Hit-to-Lead: AI models can sift through chemical libraries to identify promising compounds more accurately, eliminating many dead ends early on.
• Optimized Molecular Design: Using AI to improve the selectivity and potency of their next-generation inhibitors, like BLU-808, before they even reach the lab.
• Clinical Trial Efficiency: AI is used to optimize trial design and help recruit suitable participants, which is crucial for rare diseases like systemic mastocytosis.

This technological adoption is critical for maintaining a competitive pipeline and is a key part of the scalable innovation and operational excellence that underpins their growth strategy.

Blueprint Medicines Corporation (BPMC) - PESTLE Analysis: Legal factors

The legal landscape for Blueprint Medicines Corporation has been fundamentally reshaped in 2025, primarily due to the acquisition by Sanofi and the strategic divestiture of Gavreto, shifting the focus from direct commercial litigation to managing complex collaboration agreements and maintaining the high-value intellectual property (IP) portfolio for Ayvakit.

Maintaining patent exclusivity for Ayvakit (avapritinib) and Gavreto (pralsetinib) against generic competition.

Protecting the core assets, particularly Ayvakit, is the most critical legal priority. For Ayvakit, the legal strategy centers on a layered defense of patents and regulatory exclusivities (NCE and Orphan Drug Exclusivity, or ODE) that extend well into the next decade. The estimated generic launch date for Ayvakit is far out, projected for March 8, 2042, based on its patent portfolio.

This long IP runway is a key reason for the Sanofi acquisition. Still, the company must actively defend against Paragraph IV certifications (generic challenges) that have been possible since January 10, 2024. For Gavreto, the legal risk has been largely transferred; the US rights sale to Rigel Pharmaceuticals means Blueprint Medicines Corporation's exposure is now limited to contract adherence and royalty collection, not the direct cost of patent defense in the US market.

Evolving global data privacy laws (e.g., GDPR) affecting clinical trial data management.

Data privacy compliance, particularly with the European Union's General Data Protection Regulation (GDPR), is a persistent and costly legal obligation. As a multinational pharmaceutical company, Blueprint Medicines Corporation handles vast amounts of sensitive patient data from clinical trials, which triggers the highest level of scrutiny.

The company has proactively addressed this by certifying its adherence to the EU-U.S. Data Privacy Framework (DPF), a key legal mechanism for transatlantic data transfers, effective as of October 8, 2025. This certification helps ensure the legal basis for moving clinical trial data from the EU to the US, but it requires continuous, resource-intensive maintenance.

For large global enterprises in the highly-regulated healthcare sector, the internal and external costs for initial GDPR compliance and ongoing maintenance are substantial, often exceeding $1 million annually. Failure to comply carries a maximum penalty of €20 million or 4% of annual global revenue, whichever is higher, so the investment is defintely a risk mitigation action.

Complex licensing and collaboration agreements, such as the one with Roche/Genentech for Gavreto.

The legal complexity around Gavreto has shifted from a co-development arrangement with Roche/Genentech to a multi-party divestiture and royalty structure. The original collaboration with Roche/Genentech was terminated, effective February 22, 2024.

Blueprint Medicines Corporation then executed a new legal arrangement, selling the US rights to Rigel Pharmaceuticals. This deal provides Blueprint Medicines Corporation with a purchase price of $15.0 million (paid in two tranches) and eligibility for up to $102.5 million in future regulatory and commercial milestone payments, plus tiered royalties ranging from 10% to 30% on US net sales. The legal risk here is managing the performance and compliance of Rigel Pharmaceuticals to ensure full payment of milestones and royalties.

Additionally, the exclusive collaboration and license agreement with CStone Pharmaceuticals for Gavreto in Greater China (Mainland China, Hong Kong, Macau, and Taiwan) remains a separate, complex legal entity that requires continuous oversight.

Strict FDA/EMA requirements for post-marketing surveillance and real-world evidence generation.

Regulatory approval is not the end of the legal journey; it triggers stringent post-marketing obligations. The FDA and the European Medicines Agency (EMA) require continuous pharmacovigilance (drug safety monitoring) and the generation of Real-World Evidence (RWE) to confirm the long-term safety and effectiveness of approved drugs like Ayvakit.

These requirements mandate a robust compliance program that includes:

• Maintaining an Adverse Event Reporting System (FAERS in the US, EudraVigilance in the EU).
• Implementing Risk Evaluation and Mitigation Strategies (REMS) where required.
• Conducting required post-marketing studies to fulfill conditional or accelerated approvals.

For example, while Ayvakit's approval for Indolent Systemic Mastocytosis (ISM) was a full approval, the company must still manage the legal risk of potential label changes or withdrawals if new safety signals emerge from the broader patient population. This continuous regulatory compliance is a significant operational and legal cost, but it's non-negotiable for maintaining market access.

Blueprint Medicines Corporation (BPMC) - PESTLE Analysis: Environmental factors

The environmental factors for Blueprint Medicines Corporation (BPMC) in 2025 are primarily driven by escalating regulatory and investor demands for transparency, especially concerning the carbon footprint of their outsourced supply chain and the management of hazardous R&D waste. The company's small operational footprint means its direct environmental impact is low, but its reliance on third-party contract manufacturing organizations (CMOs) for commercial products like AYVAKIT shifts the major environmental risk to Scope 3 emissions (value chain emissions), which are harder to control.

To be fair, the biggest near-term opportunity is the commercial expansion of Ayvakit into new indications, but the biggest risk is defintely the looming IRA impact on future pricing. Finance: model a 5-year DCF scenario with a 15% price haircut post-2026 for key products by the end of next month.

Increasing investor and regulatory pressure for comprehensive Environmental, Social, and Governance (ESG) reporting

Investor scrutiny on Environmental, Social, and Governance (ESG) performance is intensifying, particularly in the US and Europe. Blueprint Medicines Corporation addresses this by aligning its disclosures with the Sustainability Accounting Standards Board (SASB) standards for the Biotechnology and Pharmaceuticals Industry. The Nominating and Governance Committee of the Board of Directors is explicitly tasked with overseeing the company's ESG policies and initiatives, including environmental matters. This governance structure is a direct response to the market's demand for clear, material sustainability data.

The acquisition by Sanofi, valued at approximately $9.1 billion in cash plus contingent value rights (CVRs) in June 2025, will significantly alter BPMC's future ESG reporting landscape. Post-acquisition, BPMC's environmental performance will likely be integrated into Sanofi's much larger, more scrutinized global sustainability framework, which will demand a higher level of Scope 3 (value chain) emissions reporting and reduction targets.

Need for sustainable supply chain practices to reduce carbon footprint in drug manufacturing

The pharmaceutical industry's carbon footprint is notoriously high, with up to 80% of emissions often categorized as Scope 3, coming from the supply chain, including raw material acquisition and manufacturing. Blueprint Medicines Corporation, as a commercial-stage biopharmaceutical company, relies on third-party Contract Manufacturing Organizations (CMOs) for its commercial drug supply, including key raw materials sourced from regions like China. This outsourcing model means BPMC's own direct (Scope 1 and 2) emissions are minimal, but its Scope 3 emissions are substantial and largely outside its direct operational control.

To mitigate this risk and meet emerging standards, BPMC must push its CMOs to adopt green chemistry principles and renewable energy sources. Failure to do so exposes the company to supply chain disruptions and regulatory non-compliance, especially with the European Union's Corporate Sustainability Reporting Directive (CSRD) indirectly influencing global supply chain partners.

Managing and reducing hazardous waste from R&D laboratories and clinical trial materials

The core of BPMC's environmental challenge lies in its Cambridge, Massachusetts-based research and development (R&D) operations, which generate hazardous waste. The company maintains hazardous and non-hazardous waste management protocols and contracts with third parties for disposal to ensure compliance with all local, state, and federal regulations.

While the company does not publicly disclose its total hazardous waste volume for 2024 or 2025, it highlights internal efforts to reduce waste, such as:

• Maintaining a hazardous waste program with routine internal inspections.
• Implementing a recycling program for laboratory materials like pipette tip boxes and media bottles.
• Recycling 1,671 pounds of plastic from its Cambridge lab facility in 2023.

What this estimate hides is the total volume of non-recyclable hazardous waste generated, which is the true environmental liability of its R&D engine.

Climate change risks potentially disrupting global manufacturing and distribution logistics

Climate change poses a direct, material risk to the pharmaceutical supply chain, particularly for a company like Blueprint Medicines Corporation that relies on a global network of third-party suppliers and manufacturers. Extreme weather events, such as the 2023 tornado that severely damaged a Pfizer manufacturing plant, illustrate the immediate threat to drug production capacity.

BPMC's risk exposure is heightened by its reliance on third parties in China for the manufacture and supply of certain raw materials. Any climate-related disruption in this region could materially affect the supply of its commercial product, AYVAKIT, which is projected to generate approximately $680 million to $710 million in global net product revenues in 2025. The company conducts an annual Enterprise Risk Assessment that covers risk areas and maintains a Disaster Recovery and Business Continuity Policy, which is tested annually, to mitigate the impact of such disruptions.