Akero Therapeutics, Inc. (AKRO): PESTLE Analysis [Nov-2025 Updated]

You're looking at Akero Therapeutics, Inc. (AKRO) and seeing a high-stakes bet on one molecule: efruxifermin (EFX). The entire strategic outlook is defintely hinged on the regulatory and political landscape, not just the balance sheet. While their cash reserves are strong, estimated near $850 million as of Q3 2025, the R&D burn for Phase 3 is substantial, estimated at $320 million for the fiscal year. We need to look past the financials and map the external forces-from rising FDA scrutiny to the Q1 2026 EFX data catalyst-to understand the real risk and opportunity in this $3.5 billion market capitalization play.

Akero Therapeutics, Inc. (AKRO) - PESTLE Analysis: Political factors

Increased FDA scrutiny on accelerated approval pathways for MASH (Metabolic Dysfunction-associated Steatohepatitis) drugs

You need to understand that the regulatory environment for MASH drugs is shifting from a green light to a more cautious amber, even with recent approvals. The U.S. Food and Drug Administration (FDA) is still using the accelerated approval pathway for MASH, which is a huge opportunity for Akero Therapeutics, Inc.'s Efruxifermin (EFX), but the scrutiny on post-marketing requirements is intense.

This is not a free pass. The FDA's August 2025 accelerated approval of Novo Nordisk's Wegovy (semaglutide) for MASH, following Madrigal Pharmaceuticals' Rezdiffra in 2024, confirms the pathway is viable for drugs that show a clear histological benefit (like MASH resolution or fibrosis improvement) based on a surrogate endpoint. Specifically, the Wegovy approval was based on interim data showing 63% of patients achieved MASH resolution with no worsening of fibrosis, compared to 34% on placebo.

But here's the kicker: both approvals require lengthy, confirmatory Phase 3 trials to validate long-term clinical benefit, such as a reduction in liver-related clinical events. For Wegovy, the ESSENCE trial's Part 2 is not expected to read out until 2029. This means Akero Therapeutics must be defintely prepared to commit substantial capital and time to a multi-year, large-scale confirmatory trial post-approval, or risk a withdrawal if the clinical benefit isn't proven.

Potential for new US legislation impacting drug pricing, specifically for high-cost biologics

The political pressure to lower drug prices in the U.S. is a major headwind, especially for high-cost biologics like Efruxifermin will be. Biologics represented only 5% of U.S. prescriptions in 2024, but they accounted for over 50% of the country's total prescription medicine spending.

We are seeing multiple legislative and executive actions targeting this imbalance in 2025:

• The 'Fair Prescription Drug Prices for Americans Act' (S. 1435/H.R. 3546), introduced in May 2025, proposes linking U.S. drug prices to the average price in six developed countries (Canada, France, Germany, Japan, Italy, and the United Kingdom).
• Violators of this international price cap would face steep financial penalties, specifically a fine 10 times the price difference per unit sold.
• The 'Prescription Drug Price Relief Act of 2025' (H.R. 3546) aims to waive government-granted monopolies and grant open licenses to other manufacturers if a brand-name drug's price is determined to be excessive compared to five reference countries.

Here's the quick math: If Akero Therapeutics launches a novel MASH biologic at a high price point, it immediately becomes a target for these price-control mechanisms. The risk isn't just a lower price, but a potential loss of market exclusivity (the 'monopoly') years earlier than expected, which would decimate long-term revenue projections.

Geopolitical tensions affecting global supply chain stability for clinical trial sites and drug components

Geopolitical instability is no longer just a macro-risk; it's a line item on the R&D budget. For a biotech company like Akero Therapeutics, Inc. that relies on global clinical trial sites and a complex supply chain for its drug substance, the recent trade policies and conflicts are increasing costs and timelines.

The U.S. administration's trade policy shifts in 2025 are particularly impactful:

• New U.S. tariffs announced in July 2025 are expected to affect over 150 countries, with initial rates of 20-40% on various goods, including pharmaceuticals.
• A consolidated tariff of 55% on Chinese imports came into effect on June 11, 2025, directly increasing the cost of Active Pharmaceutical Ingredients (APIs) and other components sourced from China.
• Geopolitical tensions, such as the Israel-Iran conflict in June 2025, drove Brent crude prices up to approximately $74/barrel (a 16.9% month-over-month increase from May 2025), which increases the cost of polymer feedstocks critical for bioprocessing systems.

This instability is also pushing clinical trial activity out of the U.S. Regulatory uncertainty is prompting some biotech firms to relocate early-stage trials to markets like Australia, where trials can start within 6-8 weeks, despite the added cost of about $1 million in filing fees.

Government funding priorities shifting towards obesity and metabolic disorders research

The political focus on obesity and metabolic disorders is creating a mixed, but largely favorable, environment for research funding, which can de-risk early-stage science for companies like Akero Therapeutics, Inc.

The National Institutes of Health (NIH), specifically the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), continues to prioritize this area. We see multiple funding opportunities posted in 2025, including those focused on 'Nutrition Obesity Research Centers (NORCs)' and 'Optimal Treatment Strategies for use of Anti-Obesity Medications (AOMs).'

However, you need to watch the public health side. The President's Fiscal Year (FY) 2026 budget request proposes the near total elimination of the National Center for Chronic Disease Prevention and Health Promotion at the Centers for Disease Control and Prevention (CDC).

This is a critical distinction:

The government is backing the science, but it's pulling back on the public health infrastructure needed to identify the 14.9 million U.S. adults estimated to have MASH. That's a potential bottleneck for commercial adoption.

Akero Therapeutics, Inc. (AKRO) - PESTLE Analysis: Economic factors

The economic landscape for a clinical-stage biotech like Akero Therapeutics is less about revenue and more about capital efficiency and runway. You need to look at their balance sheet as a strategic asset, not just an accounting ledger. The key takeaway is that Akero is well-capitalized to execute its Phase 3 strategy, but the high-interest-rate environment still pressures future financing options.

Strong cash reserves of approximately $850 million as of Q3 2025, providing a long runway.

As of Q3 2025, Akero Therapeutics holds strong cash reserves, cash equivalents, and marketable securities, estimated near $850 million. This figure is a critical buffer, especially for a company with no commercial revenue, and it provides a projected cash runway that extends well into 2028, according to management. This defintely gives them significant operating flexibility, insulating them from the immediate need to raise capital at potentially unfavorable valuations.

For context, the cash balance was $1,086.2 million at the end of Q2 2025, following a significant capital raise in January 2025. The subsequent cash burn, typical for a biotech in late-stage trials, brings the Q3 figure down, but the overall position remains robust. This long runway is the single most important economic factor right now.

Estimated Research & Development (R&D) expense for fiscal year 2025 is around $320 million, driven by Phase 3 trials.

The core of Akero's economic activity is its R&D spend. The estimated R&D expense for the full fiscal year 2025 is around $320 million. This massive investment is directly tied to the advancement of their lead product candidate, efruxifermin (EFX), particularly the three concurrent Phase 3 SYNCHRONY studies (Histology, Real-World, and Outcomes).

Here's the quick math: R&D expenses were $69.6 million in Q1 2025 and $69.3 million in Q2 2025. The full-year projection of $320 million accounts for the accelerated manufacturing scale-up for clinical supplies and potential marketing applications, plus higher personnel costs to manage the complex, global Phase 3 program. This is a high-cost, high-reward phase.

• Q1 2025 R&D Expense: $69.6 million.
• Q2 2025 R&D Expense: $69.3 million.
• Primary Cost Drivers: Phase 3 SYNCHRONY trials and clinical supply manufacturing.

High interest rate environment increasing the cost of capital for potential future debt financing.

While Akero is not currently dependent on debt, the prevailing high interest rate environment-driven by the Federal Reserve's efforts to combat inflation-significantly increases the cost of capital for any potential future debt financing. This isn't an immediate problem, but it's a strategic risk. If the company needed to secure a large loan (say, a $500 million facility) for a commercial launch build-out in 2027, the interest rate would be materially higher than it was in 2022.

The current environment means that equity financing, while dilutive, remains the more attractive option compared to high-cost debt, especially since the company has minimal total debt, reported at only $605,000. This low debt load is a strength, but the overall cost of capital (WACC) is still elevated by the macro environment.

Market capitalization estimated near $3.5 billion, reflecting significant clinical risk/reward.

The company's market capitalization is a direct reflection of investor sentiment regarding the potential success of EFX. As of November 2025, the market cap is approximately $4.47 billion, significantly higher than the $3.5 billion enterprise value. This valuation is typical for a mid-cap biotech with a promising, late-stage asset targeting a massive market-metabolic dysfunction-associated steatohepatitis (MASH), which affects an estimated 17 million Americans.

The market cap is a forward-looking value, essentially a bet on the drug's approval and commercial success. The fact that the enterprise value is lower than the market cap is due to the large cash position. What this estimate hides, however, is the extreme volatility; the stock's 52-week range has been between $21.87 and $57.56, showing how quickly the valuation can swing on clinical trial news.

Next step: Strategy team should model the impact of a 200-basis-point increase in the benchmark interest rate on a hypothetical $750 million debt raise for commercialization in 2027.

Akero Therapeutics, Inc. (AKRO) - PESTLE Analysis: Social factors

Rising global prevalence of MASH/NASH, fueled by the obesity and type 2 diabetes epidemics, creating massive market demand.

You can't look at the MASH (Metabolic Dysfunction-Associated Steatohepatitis) market without seeing the overwhelming social trends driving its growth. This isn't a niche disease; it's a massive public health crisis tied directly to the global obesity and Type 2 diabetes epidemics. Honestly, the numbers are staggering.

The US adult MASH population alone was an estimated 14.9 million people in 2020, and this is projected to climb to 18.4 million people by 2030. That's a 6.7% prevalence in US adults. The disease is also deeply intertwined with other metabolic conditions: globally, almost 69% of patients with Type 2 diabetes have MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease, formerly NAFLD). Plus, of those living with MASH, more than 8 in 10 also have obesity, and over 40% have Type 2 diabetes. It's a huge, expanding patient pool that needs effective treatment, and that's the clear opportunity for Akero Therapeutics.

Here's a quick look at the US burden of advanced disease, which is Akero's primary target:

What this estimate hides is the urgency: the number of patients with advanced MASH (F $\ge$ F2) is growing much faster than the overall MASH population. This group is at high risk of progression to cirrhosis and liver cancer, making them the most critical target for new therapies like Akero's Efruxifermin.

Growing patient advocacy and awareness groups pushing for non-invasive, effective therapeutic options.

The patient voice is getting loud, and that's a good thing for drug developers who are focused on patient-friendly solutions. Patient advocacy groups like the Global Liver Institute (GLI) and the Fatty Liver Foundation (FLF) have been instrumental in the recent shift in nomenclature from NASH to MASH, specifically to remove the stigmatizing terms 'non-alcoholic' and 'fatty.'

This push is all about reducing stigma and increasing early diagnosis, which directly translates into a demand for less invasive diagnostics and treatments. The current gold standard for MASH diagnosis is still an invasive liver biopsy, which many patients refuse. The advocacy agenda for 2024 and 2025 has centered on:

• Promoting non-invasive diagnostic biomarkers.
• Enhancing patient-centered clinical trial design.
• Increasing public education and screening.

If a drug can show strong efficacy without requiring a biopsy as the sole endpoint, or if it works alongside a new non-invasive test, patient adoption will defintely be faster. This social pressure is forcing the industry to prioritize patient experience.

Focus on health equity and access to innovative treatments for chronic liver diseases in diverse populations.

Health equity is a major theme in 2025, especially concerning chronic diseases like MASH where prevalence shows significant racial and ethnic disparities. The disease burden is not evenly distributed across the US population.

Data shows that MASH prevalence is highest among Hispanic individuals at 45.4%, compared to 32.2% in non-Hispanic White and 20.3% in non-Hispanic Black individuals. This disparity is often compounded by systemic barriers related to socioeconomic factors and social determinants of health, which can lead to delayed diagnosis and more advanced disease by the time a patient finally gets care.

For a company like Akero, this means that success isn't just about efficacy; it's about ensuring their commercial strategy addresses access and affordability in these high-prevalence, underserved communities. Managed care organizations are already being urged to prepare for implementing equitable treatment management strategies. Ignoring this social imperative will lead to payer pushback and limited market penetration.

Public perception of injectable biologics versus oral treatments influencing patient adoption rates.

The MASH treatment landscape is quickly dividing into oral and injectable options, and patient preference is a key factor in adoption. Akero's Efruxifermin (AKR-001) is an injectable biologic, which puts it in direct competition with the oral option, Resmetirom, and other injectable GLP-1 agonists like Semaglutide, which is expected to gain a MASH indication.

While an oral pill is often preferred for convenience, patient surveys show that the primary drivers for treatment choice are efficacy and impact on symptoms, not just the route of administration. This is where a highly effective injectable can overcome the preference for a pill. For example, physicians are already showing a strong preference for Semaglutide (an injectable for obesity/T2D) for MASH treatment, with 52% to 75% of specialists saying they would be 'very likely' to prescribe it if approved. This suggests that high efficacy trumps the inconvenience of an injection for a life-threatening disease like MASH.

Akero needs to clearly articulate the superior efficacy and safety profile of Efruxifermin to justify the injectable format. The key trade-off for the patient is simple: a less convenient route of administration for a potentially greater therapeutic benefit, especially for advanced fibrosis. Safety profiles and reimbursement policies will ultimately guide the individual choice.

Akero Therapeutics, Inc. (AKRO) - PESTLE Analysis: Technological factors

Technology is a double-edged sword for Akero Therapeutics; it presents a clear path to faster, more precise clinical development but also fuels the massive competitive threat from other drug classes. Your core technological risk hinges on the near-term clinical data readout, but the long-term opportunity lies in embracing non-invasive diagnostics and artificial intelligence (AI) to redefine the MASH (Metabolic Dysfunction-Associated Steatohepatitis) treatment paradigm.

Efruxifermin (EFX) Phase 3 HARMONY study data readout is a critical near-term catalyst, expected in early Q1 2026.

The most immediate and high-stakes technological event is the readout from the Phase 3 SYNCHRONY program, which builds on the earlier Phase 2b HARMONY study. Specifically, the preliminary topline results for the SYNCHRONY Real-World study are expected in the first half of 2026. This trial is critical because it assesses the safety and tolerability of Efruxifermin (EFX) in patients diagnosed using non-invasive methods, reflecting how the drug would be used in real-world clinical practice.

The main Phase 3 registrational trial, SYNCHRONY Histology, which uses the traditional liver biopsy endpoint for accelerated approval, has its 52-week results anticipated in the first half of 2027. The successful use of a pre-filled device, the LyoJect 3S dual chamber syringe, in these Phase 3 studies also demonstrates a key technological advancement for commercial readiness, supporting convenient once-weekly self-administration by patients.

Advancements in non-invasive diagnostic tools (e.g., imaging, biomarkers) for MASH/NASH are changing trial enrollment and monitoring.

The technology for diagnosing and monitoring MASH is rapidly shifting away from the invasive liver biopsy, which is painful and prone to sampling error. This shift is a major tailwind for drug development, potentially reducing screening failures and improving patient recruitment for trials like Akero's.

Key non-invasive tests (NITs) now play a central role in clinical practice and are increasingly accepted in trial design:

• Enhanced Liver Fibrosis (ELF) Test: A blood-based biomarker panel that correlates with liver fibrosis severity.
• Transient Elastography (TE): An ultrasound-based technique (e.g., FibroScan) that measures liver stiffness, a proxy for fibrosis.
• Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI-PDFF): Highly accurate imaging for quantifying liver fat, a key measure of treatment response.

Akero Therapeutics has already embraced this trend; the SYNCHRONY Real-World study, which enrolled 601 patients, included individuals with MASH or MASLD diagnosed non-invasively. This is defintely the future of MASH trials.

Competition from other drug classes, like GLP-1 agonists, pushing the need for best-in-class efficacy and safety.

The technological and market dominance of Glucagon-like Peptide-1 (GLP-1) receptor agonists, primarily used for diabetes and obesity, creates immense competitive pressure. These drugs, while not solely focused on MASH, drive significant metabolic improvements that impact liver health. You need a drug like EFX to be best-in-class or, better yet, complementary.

The sheer scale of the competition is staggering, and it's backed by massive 2025 fiscal year revenue projections:

Here's the quick math on EFX's differentiation: Phase 2b data showed EFX, when added to a stable dose of a GLP-1 drug, resulted in a 65% relative reduction in liver fat after 12 weeks. This compares favorably to a mere 10% drop in the GLP-1-placebo control arm, suggesting EFX's mechanism (an FGF21 analog) is truly complementary to the GLP-1 class.

Use of AI/machine learning to optimize clinical trial design and patient selection, potentially reducing trial costs.

AI is now a formal technological tool in MASH drug development, moving beyond just buzzwords. In March 2025, the European Medicines Agency (EMA) issued a Qualification Opinion for the AIM-NASH tool, an AI-based digital pathology system developed by PathAI.

This tool uses machine learning to analyze liver biopsy scans, addressing the high variability among human pathologists. The technology is expected to enhance trial reliability and efficiency by:

• Reducing the pathologist variability that causes screening failure in trials.
• Potentially allowing for smaller clinical trials with fewer patients to obtain clearer evidence.
• Providing a continuous scoring scale (e.g., HistoIndex's qFibrosis®) that reduces placebo noise, making a drug's true anti-fibrotic effect easier to differentiate.

Akero Therapeutics is already on this trend, using AI-powered digital analysis in a post-hoc analysis of its 96-week Phase 2b HARMONY study data, which showed concordance between the AI-based histology scores and non-invasive tests like the ELF score and FibroScan measurement.

Akero Therapeutics, Inc. (AKRO) - PESTLE Analysis: Legal factors

Patent protection and intellectual property (IP) enforcement for efruxifermin against biosimilar competition

For a clinical-stage biotech like Akero Therapeutics, the entire valuation hinges on intellectual property (IP) protection for efruxifermin (EFX), a novel biologic. You need to defintely track their patent estate closely because biosimilar competition is the single biggest threat to long-term revenue. The company's core strategy, once EFX is approved, will be to apply for Patent Term Extension (PTE) in the U.S., a process that can add up to five years of market exclusivity to compensate for time lost during clinical trials.

Right now, the focus is on strengthening the patent portfolio to cover the molecule, its manufacturing process, and its use in treating MASH (metabolic dysfunction-associated steatohepatitis). The legal team must be ready to enforce these patents aggressively against any potential biosimilar entrants, a costly but necessary action to protect what could be a multi-billion dollar asset.

Strict compliance with global clinical trial regulations (GCP) across all Phase 3 sites internationally

Running three concurrent Phase 3 trials-SYNCHRONY Histology, SYNCHRONY Outcomes, and SYNCHRONY Real-World-means the company is managing a complex web of global regulatory requirements, specifically Good Clinical Practice (GCP).

This scale-up is why Research and Development (R&D) expenses are so high. For the three-month period ended June 30, 2025, Akero Therapeutics reported R&D expenses of $69.3 million, a 25.3% increase year-over-year, driven largely by the cost of these complex global studies and manufacturing scale-up. Any misstep in GCP compliance, even at a single international site, could lead to the U.S. Food and Drug Administration (FDA) or European Medicines Agency (EMA) rejecting the data, causing a massive delay and a loss of billions in potential market capitalization. It's a high-stakes compliance game.

Here is a quick look at the financial impact of this compliance and operational scale:

Potential for product liability litigation post-approval, common with novel biologic therapies

Once EFX is approved and commercialized, the risk shifts from clinical trial compliance to product liability. As a novel biologic, even with a strong safety profile, the company faces inherent exposure to costly and damaging product liability claims if unforeseen harmful side effects emerge post-launch.

To be fair, the Phase 2b SYMMETRY data showed EFX was generally well-tolerated, with the most frequent adverse events being Grade 1 or 2 gastrointestinal (GI) issues like diarrhea and nausea. Still, even a manageable side effect profile doesn't eliminate the litigation risk. The company must establish adequate insurance reserves and robust pharmacovigilance (post-market safety monitoring) systems to mitigate this financial and reputational exposure.

Compliance with the Health Insurance Portability and Accountability Act (HIPAA) regarding patient data privacy

Since Akero Therapeutics is a U.S.-based company conducting clinical trials involving protected health information (PHI), strict adherence to the Health Insurance Portability and Accountability Act (HIPAA) is non-negotiable. This isn't just about clinical data; it extends to all patient information handled by the company and its third-party vendors.

The legal compliance burden also covers a broader spectrum of U.S. healthcare laws, including anti-kickback statutes and the False Claims Act, which govern future commercial relationships with physicians and payors. This legal overhead is a significant component of the $11.6 million in General and Administrative (G&A) expenses reported for Q2 2025, which pays for the professional services and personnel needed to manage this regulatory complexity.

• Audit data systems: Ensure all PHI storage meets HIPAA Security Rule standards.
• Train all personnel: Mandate annual training on data privacy and anti-kickback laws.
• Vet third-party vendors: Require Business Associate Agreements (BAAs) for all data handlers.

Next Step: Legal Counsel: Conduct a full IP landscape analysis by Q1 2026 to identify and file for all possible secondary patents covering EFX formulations and combination therapies.

Akero Therapeutics, Inc. (AKRO) - PESTLE Analysis: Environmental factors

You're looking at a clinical-stage biotech, so the environmental challenge for Akero Therapeutics, Inc. isn't a factory smokestack; it's the supply chain and clinical trial waste. The industry's environmental footprint is substantial-about 55% higher in greenhouse gas emissions than the automotive sector-and for a company like Akero, the indirect, or Scope 3, emissions from suppliers account for roughly 80% of the total impact. Your focus, then, must be on vendor due diligence and waste management compliance, which is getting much stricter in 2025.

Need for sustainable manufacturing practices for biologic drug production to meet Environmental, Social, and Governance (ESG) standards

The core of Akero's environmental risk lies in its reliance on Contract Manufacturing Organizations (CMOs) for its lead candidate, efruxifermin (EFX), a biologic drug. Biologic production is resource-intensive, requiring significant energy and water for cell culture, purification, and sterile conditions. To meet rising investor and regulatory ESG standards, Akero must push its CMOs to adopt sustainable bioprocessing materials and green chemistry practices. For instance, the broader pharmaceutical industry is under pressure to cut its emissions intensity by 59% from 2015 levels by the end of 2025 to align with the Paris Agreement goals. This isn't just a compliance issue; it's a capital markets requirement.

Here's the quick math: Akero's Research and Development (R&D) expenses, which include the manufacture of clinical supplies, were $69.6 million in Q1 2025 and $69.3 million in Q2 2025. A significant portion of this spend flows directly into the supply chain, which is the source of the majority of the industry's carbon footprint. Your action is to integrate environmental metrics into your CMO contracts now.

Managing the environmental impact of clinical trial waste and supply chain logistics globally

Akero is running large, multi-site Phase 3 clinical studies-SYNCHRONY Histology, SYNCHRONY Outcomes, and SYNCHRONY Real-World-for EFX. These global trials generate substantial clinical trial waste, including used syringes, needles, packaging, and unused or expired drug product. The company's net impact analysis already highlights 'Waste' as a category where its positive outcomes are achieved by causing negative impacts. This is a concrete limit.

The logistics of shipping temperature-sensitive biologic supplies and trial materials worldwide also contribute heavily to Scope 3 emissions. The industry's top strategies for addressing this in 2025 include:

• Transitioning to renewable energy sources for manufacturing and cold chain logistics.
• Implementing sustainable supply chain practices, which is the hardest part.
• Focusing on packaging optimization to reduce material volume and weight.

Regulatory pressure to reduce the carbon footprint of pharmaceutical operations and distribution

Regulatory scrutiny on pharmaceutical waste and emissions is intensifying in 2025, especially in the US. The Environmental Protection Agency (EPA)'s Management Standards for Hazardous Waste Pharmaceuticals (Subpart P) are being adopted and enforced by many states, which directly impacts how clinical trial sites and healthcare facilities manage waste.

The most critical change is a nationwide ban on the sewering (flushing down the drain) of any hazardous waste pharmaceuticals, which includes many active pharmaceutical ingredients (APIs). For Akero, this means ensuring every site in the SYNCHRONY program is compliant with the new standards for accumulation, storage, and disposal within the 365-day limit.

Ensuring ethical sourcing of materials and minimizing water and energy consumption in production facilities

While Akero does not own large-scale production facilities, its commitment to ethical sourcing and resource efficiency is still measured through its value chain. The company's overall net impact ratio is 75.6%, which, while positive, indicates room for improvement in resource usage.

Minimizing water and energy consumption is a direct cost-saver and a key ESG metric for investors. In biologic manufacturing, this means adopting continuous manufacturing processes, which are known to reduce energy consumption, waste generation, and raw material use. This is the future of efficient drug production.

Your team needs to start asking your CMOs for their specific metrics on:

• Water-to-product ratio (liters of water per kilogram of API).
• Energy-to-product ratio (kWh per kilogram of API).
• Waste reduction targets, especially for solvents and single-use bioprocessing materials.

Honestly, the pressure to demonstrate these metrics will only increase as EFX moves closer to potential commercialization, which will scale up the manufacturing footprint exponentially.