NeuroOne Medical Technologies Corporation (NMTC): PESTLE Analysis [Nov-2025 Updated]

You're looking for a clear, actionable breakdown of the external forces shaping NeuroOne Medical Technologies Corporation (NMTC), and honestly, the landscape for a small-cap neuro-device company is a defintely tight wire act between technological innovation and commercial reality. The direct takeaway is that while their proprietary thin-film electrodes offer a strong technological moat, near-term success hinges entirely on the Zimmer Biomet partnership and managing a capital-intensive R&D pipeline against a backdrop of tight federal budgets. Here's the quick math: NMTC's projected 2025 R&D and G&A spend of over $12 million dwarfs their expected revenue, which is likely to be below $3 million, meaning capital raises are a constant reality. So, we need to map these external Political, Economic, Sociological, Technological, Legal, and Environmental (PESTLE) forces-from high interest rates to the ethical debate around future brain-computer interfaces (BCI)-to see where the real risks and opportunities lie for your investment thesis.

NeuroOne Medical Technologies Corporation (NMTC) - PESTLE Analysis: Political factors

For a company like NeuroOne Medical Technologies Corporation, political factors are less about broad policy and more about hyper-specific regulatory and fiscal decisions that directly impact your time-to-market and cost structure. The key takeaway for 2025 is a mixed bag: a major tax risk is off the table, but regulatory timelines are still a quagmire, and global trade friction is hitting your component costs right now.

Shifting FDA approval timelines create high commercial risk for new devices.

The U.S. Food and Drug Administration (FDA) approval process is the single biggest political risk to your commercialization strategy. Your devices, like the Evo® sEEG Electrode, fall under Class II or Class III, meaning the time and cost to market are highly sensitive to regulatory shifts and internal FDA bandwidth.

While the FDA works under performance goals set by the Medical Device User Fee Amendments (MDUFA V), the real-world timeline is often far longer than the official clock. You can't control the FDA's pace, so you must control your submission quality.

Here's the quick math on the 2025 regulatory landscape, which dictates your cash burn rate before you can sell a product:

The PMA process, required for high-risk devices, is the real time-sink, with the FDA aiming for an average total time to decision of approximately 285 days across the FY 2025-2027 period, but the average total review time is closer to 363.2 days. Plus, the standard PMA user fee for fiscal year 2025 is a substantial $483,560, a major upfront cost for a small-cap company. If your submission is incomplete, an Additional Information (AI) request can put your application on hold for 180 days or more, stalling your revenue timeline defintely.

Potential reinstatement of the US medical device excise tax impacting profitability.

Honesty, this is a risk that has been largely mitigated, but it always lurks in the background of healthcare policy debates. The controversial 2.3% excise tax on the sale price of taxable medical devices was originally part of the Affordable Care Act (ACA).

The good news is that the tax was permanently repealed on December 20, 2019, and sales of taxable medical devices after December 31, 2015, are not subject to it. This means you do not have to factor a 2.3% reduction in gross revenue into your 2025 financial models. Still, any future legislative effort to fund healthcare initiatives could resurrect a similar tax, instantly eroding your gross margins and R&D budget.

Federal funding for neurological research (NIH) influences early-stage development grants.

Federal funding, primarily through the National Institutes of Health (NIH), is a critical leading indicator for the entire neurological device ecosystem. While NeuroOne Medical Technologies Corporation is a commercial-stage company, a healthy grant environment feeds the academic and clinical research that validates and drives adoption of new neurotechnology.

The political climate around federal spending has created significant headwinds for new research in fiscal year 2025. The NIH's two main neuroscience-focused institutes-the National Institute of Neurological Disorders and Stroke (NINDS) and the National Institute of Mental Health (NIMH)-have awarded 37 percent fewer new neuroscience-related grants in FY2025 compared to the previous nine-year average.

This decline, driven by a new NIH policy requiring multiyear grants to be funded with a single upfront lump sum, reduces the number of new research projects that could eventually become clinical partners or early adopters of your technology. The NINDS budget request for FY2025 was $2,833.8 million, but a shift in how that money is allocated-favoring renewals over new projects-is what matters. Fewer new grants means a slower pipeline of foundational science for the next generation of neuro-devices.

Trade tensions affect global supply chains for specialized components.

Geopolitical tensions, particularly with China, are translating directly into higher costs for your specialized components, like electronic sensors and titanium alloys. The medical device industry relies on complex global supply chains, and new tariffs in 2025 are introducing significant friction.

Supply chain leaders are estimating a 3 to 6 percent cost increase due to tariff-driven inflation. For components sourced from China, tariffs can be steep. For example, tariffs on raw materials like titanium and semiconductors from China have been reported at 15%. Other Chinese medical imports face an effective tariff rate of around 30% due to a combination of baseline and specialized levies.

This political instability forces a clear action: you must diversify your sourcing away from high-tariff regions like China and explore nearshoring options to countries like Mexico or India, or even reshoring to the U.S., to maintain cost stability and a reliable component flow. Supply chain diversification is now a political risk mitigation strategy.

NeuroOne Medical Technologies Corporation (NMTC) - PESTLE Analysis: Economic factors

High Cost of Capital and Equity Dilution

While the broader economic environment of high interest rates increases the cost of capital for most development-stage companies, NeuroOne Medical Technologies Corporation's (NMTC) primary cost of capital risk is currently centered on equity dilution, not debt. The company reported being debt-free as of June 30, 2025, which shields it from the immediate pressure of rising benchmark interest rates on borrowing costs. However, securing the necessary capital to fund operations through at least fiscal year 2026 required an oversubscribed public offering in April 2025, which raised approximately $8.2 million in net proceeds. This capital structure means high interest rates act as a high hurdle rate for project returns, but the more direct economic impact is the dilution of existing shareholders.

The reliance on equity is a classic trade-off for a pre-profitability MedTech firm. It ensures a strong cash position-$8.0 million in cash and cash equivalents as of June 30, 2025-but it continually increases the share count. This is the defintely the most expensive form of financing for a growing company.

Inflationary Pressure and Margin Resilience

Inflationary pressure, particularly in raw materials and specialized labor, is a constant headwind for medical device manufacturers of single-use electrodes. However, NMTC has demonstrated a strong ability to manage these costs through operational efficiencies and scaling. The company has a domestic supply chain, which helps mitigate the volatility of global tariffs and some international supply chain inflation.

The most concrete evidence of this management is the significant expansion of product gross margin. Management raised its fiscal year 2025 product gross margin guidance to a range of 50% to 53%, up from the previous guidance of 47% to 51%. This is a huge jump from the 31% product gross margin reported for fiscal year 2024. Here's the quick math on the margin story:

This margin expansion is crucial because it shows that for every dollar of product revenue, the company retains significantly more to cover operating expenses, accelerating the path toward profitability even with persistent macro-inflation.

Reimbursement Rates for sEEG Procedures

Reimbursement is the lifeblood of any MedTech company. For NMTC's sEEG (stereoelectroencephalography) procedures and the OneRF Ablation System, the reimbursement landscape is a mix of pressure and opportunity. The Centers for Medicare & Medicaid Services (CMS) finalized a 2.83% reduction in the Medicare Physician Fee Schedule (MPFS) conversion factor for Calendar Year (CY) 2025, dropping it to $32.35 from $33.29 in CY 2024. This general cut puts financial pressure on hospitals and physicians, who are the ultimate buyers of NMTC's products, potentially making them more sensitive to the cost of new devices.

What this estimate hides is that private payers often follow Medicare's lead, slowly ratcheting up the pressure on procedural reimbursement overall. The key for NMTC is that their devices, like the OneRF Ablation System, must demonstrate superior clinical outcomes and cost-effectiveness to justify their price point against this backdrop of declining procedural reimbursement.

Near-Term Revenue Projections for 2025

The company's near-term revenue picture for fiscal year 2025 is significantly stronger than a 'below $3 million' figure suggests. NMTC has consistently reiterated its fiscal year 2025 product revenue guidance in the range of $8.0 million to $10.0 million. This is a projected increase of between 132% and 190% over the $3.5 million product revenue in fiscal year 2024.

For the first nine months of fiscal year 2025 (ending June 30, 2025), the company had already achieved $6.4 million in product revenue. This strong performance is underpinned by the expanded distribution partnership with Zimmer Biomet, which also generated a separate, non-product license revenue payment of $3.0 million in the first nine months of the fiscal year.

• Total Product Revenue Guidance (FY 2025): $8.0M - $10.0M
• Product Revenue Achieved (9 Months FY 2025): $6.4M
• License Revenue Received (9 Months FY 2025): $3.0M

The bottom line is that the revenue ramp is real, but the company still reported a net loss of $2.0 million for the first nine months of fiscal 2025, which shows that while the top line is growing, the company is not yet profitable. Finance: draft a 13-week cash view by Friday to monitor burn rate against the remaining funding runway.

NeuroOne Medical Technologies Corporation (NMTC) - PESTLE Analysis: Social factors

Growing public awareness and acceptance of neuro-modulation and epilepsy surgery

The social landscape for NeuroOne Medical Technologies Corporation is defintely favorable, driven by a growing public and medical acceptance of advanced neuro-modulation techniques. For patients with drug-resistant epilepsy, which is about 30% of all epilepsy patients, traditional medication simply doesn't work. This failure rate pushes both physicians and families to consider surgical and device-based options like stereoelectroencephalography (sEEG) and radiofrequency (RF) ablation-the core of NMTC's OneRF Ablation System.

This acceptance is not just clinical; it's deeply personal. Neuromodulation, which involves implantable devices that send electrical impulses to the brain or nerves, is increasingly seen as a viable path to a better quality of life. For example, a recent study on VNS Therapy, a form of neuromodulation, found that 94% of surveyed patients and caregivers wished they had discovered the treatment sooner. That's a powerful social endorsement that helps drive the adoption of all new, effective neuro-technologies.

Aging US population increases the prevalence of neurological disorders needing treatment

The demographics of the United States are creating a massive, sustained tailwind for neurological device companies. Simply put, an aging population means more neurological disorders, and that means a larger addressable market for NMTC's diagnostic and therapeutic tools. A comprehensive analysis published in November 2025 revealed that over 180 million Americans-more than half (54%) of the U.S. population-are living with a neurological disease or disorder.

The burden is clearly shifting toward chronic management due to longer lifespans. Deaths from neurological illness have declined by 15% since 1990, but the years lived with disability have risen by 10%, meaning people are living longer with these conditions. Here's the quick math on two major conditions that drive demand for advanced neuro-care:

This trend is not slowing down. The rise in neurological disease burden is directly linked to an older U.S. population that is more vulnerable to conditions affecting the nervous system.

Ethical debate around brain-computer interfaces (BCI) could impact future product lines

While NMTC's current focus is on sEEG and ablation, their thin-film electrode technology is a platform that could extend into full Brain-Computer Interfaces (BCI). This future opportunity comes with a significant social risk: the ethical debate. The advancements by companies like Neuralink, including the first human implant in 2024, have intensified public and regulatory scrutiny on neurotechnology.

The core ethical concerns center on:

• Patient Autonomy and Consent: Ensuring patients fully understand the long-term effects of integrating BCIs into their identity.
• Data Privacy: The bidirectional nature of advanced devices raises major privacy risks for sensitive neural data.
• Therapy vs. Enhancement: The blurring line where medical treatment becomes human enhancement, which complicates regulatory oversight.

The global response is already mobilizing: Chile amended its constitution in 2021 to protect 'neurorights,' and UNESCO is preparing a global standard-setting instrument on the ethics of neurotechnology, with a proposed framework being debated in November 2025. Any future NMTC product in the BCI space will face a much tougher social and regulatory environment than current sEEG devices.

Physician training and comfort with new sEEG technology drives initial sales velocity

The adoption rate of new technology in medicine is always a social factor-it's about physician comfort and training. The good news for NMTC is that the sEEG method is now the standard of care in the U.S. for pre-surgical epilepsy evaluation. A 2022 survey showed that 92% of responding U.S. tertiary referral epilepsy centers used sEEG, and 76% used it more frequently than older sub-dural grids. This high adoption of the underlying procedure is a huge accelerator for NMTC's sEEG and OneRF Ablation products.

The company's commercial execution reflects this comfort level. As of Q1 FY2025, the OneRF Ablation System was placed in 5 prominent epilepsy centers, with sales discussions initiated at an additional 18 centers nationwide. This initial sales velocity is directly tied to the comfort and training provided by their distribution partner, Zimmer Biomet. This momentum is a key driver for the company's strong financial outlook, which projects FY2025 product revenue to range between $8.0 million and $10.0 million, representing up to 190% growth year-over-year.

NeuroOne Medical Technologies Corporation (NMTC) - PESTLE Analysis: Technological factors

When you look at NeuroOne Medical Technologies Corporation (NMTC), the technology factor isn't just a part of the business; it is the business. The core strength is a clear technological leap over incumbent solutions, but that lead is constantly challenged by the rapid pace of innovation in artificial intelligence (AI) and competitive product development. To be defintely clear, NMTC's future hinges on its ability to translate superior electrode performance into seamless, integrated surgical tools.

NMTC's proprietary thin-film electrode technology offers a clear competitive advantage.

The biggest advantage NMTC holds is its proprietary thin-film electrode platform, which fundamentally changes the invasiveness of neuro-monitoring. These electrodes are manufactured with polyimide thin film, making them over 7 times thinner than traditional silicone-based electrodes and approximately 90% thinner than some competitors' offerings. This thinness and flexibility allow for a less invasive implant, often through a dime-sized opening instead of a full craniotomy, which reduces trauma, inflammation, and recovery time for the patient.

The technical precision is a game-changer for diagnosis. For instance, the technology is cited to provide 99.7% signal accuracy in neural signal monitoring, a critical metric for pinpointing seizure onset zones. Plus, the OneRF ablation system, which leverages this platform, is the first and only FDA-cleared system for brain procedures that uses a single implant for both diagnostic monitoring and therapeutic radiofrequency (RF) ablation. You eliminate the need for a second, separate surgery, which is a massive win for both patient safety and hospital efficiency.

Rapid advancements in AI for seizure detection and brain mapping create integration opportunities.

The high-resolution data captured by NMTC's thin-film electrodes is perfectly positioned to capitalize on the explosion of AI and machine learning in neuro-diagnostics. Current research shows that AI-powered seizure prediction models can offer up to 44.8% improved performance compared to baseline methods, and some deep learning models are achieving an accuracy of 99.83% in precise epileptic seizure detection using single-channel EEG signals.

This is a huge opportunity. NMTC's technology has the potential to increase the resolution of brain recordings, which is the exact, high-quality data feed that powerful computing techniques like AI and machine learning need to function optimally. Mayo Clinic researchers, for example, are developing AI tools to pinpoint seizure hotspots more quickly and accurately, potentially reducing the duration of invasive monitoring and the associated risks like infection. The integration of NMTC's hardware with a third-party or in-house AI-driven software layer could become the next standard of care.

Competitors are also developing next-generation minimally invasive neuro-monitoring tools.

Despite NMTC's unique advantages, the neuro-monitoring market is fiercely competitive and large. The global brain monitoring equipment market is valued at $9.101 billion in 2025, and the broader Neurology Devices Market is projected to grow from $18.1 Billion in 2024 to $41.2 Billion by 2035. This growth attracts major players, so you can't get complacent.

Key competitors like Medtronic, Natus Medical, and Philips Healthcare are continuously innovating and expanding their product portfolios, focusing heavily on minimally invasive procedures and advanced diagnostic tools. While NMTC has the 'first and only' FDA-cleared single-electrode ablation system for brain procedures, the race is on for the next generation of multi-functional, minimally invasive devices. The table below shows the competitive landscape and the sheer scale of the market NMTC is operating in.

The OneBridge connection system simplifies surgical workflow, a key adoption driver.

Surgical workflow efficiency is a major driver for hospital adoption, and NMTC addresses this with its design, which includes the proprietary cable assembly and zero force connection box for the Evo electrode. This system, which simplifies the connection process, is designed to reduce the complexity and time of the procedure. For example, the single thin tail design of the Evo electrode allows it to be tunneled through one incision, which should reduce infection risk and procedure time.

The ease of use and reduced procedural steps are critical for neurosurgeons. The strong commercial traction is a direct result of this simplified workflow, which is distributed through the expanded exclusive partnership with Zimmer Biomet. This partnership underpins the company's financial guidance, which projects fiscal year 2025 product revenue to range between $8.0 million and $10.0 million, representing a massive increase of between 132% and 190% over the prior year. That kind of growth says surgeons are adopting the simplified process.

• Reduce procedure time: Single-tail electrode design.
• Lower infection risk: Fewer incisions needed.
• Easy connection: Zero force connection box.

Here's the quick math: Product gross margin is also expected to jump to a range of 47% to 51% in fiscal year 2025, up from 31% in the prior year. Higher margins often reflect a premium on innovation and manufacturing efficiency, which is what the thin-film platform and simplified connection system deliver.

NeuroOne Medical Technologies Corporation (NMTC) - PESTLE Analysis: Legal factors

You're operating in one of the most heavily regulated sectors in the world, so your legal environment isn't just a compliance checklist-it's a core strategic hurdle. For NeuroOne Medical Technologies Corporation, the legal landscape in 2025 is defined by rigorous FDA scrutiny, the need to aggressively defend proprietary technology, and the non-negotiable costs of data privacy and product safety. Honestly, your regulatory success is the only thing that unlocks revenue.

Stringent FDA 510(k) and PMA regulatory pathways govern product market entry.

The U.S. Food and Drug Administration (FDA) clearance process is the primary gatekeeper for your products. NeuroOne Medical Technologies Corporation has successfully navigated the 510(k) pathway for its core electrode technology, which is for devices deemed substantially equivalent to a legally marketed predicate device. As of late 2025, the company has 3 FDA 510(k) cleared products for use in the brain, which is a major commercial asset.

The latest win came on August 18, 2025, with the 510(k) clearance for the OneRF® Trigeminal Nerve Ablation System, which treats severe facial pain. This clearance allows for a limited commercial launch targeted for the fourth quarter of calendar 2025. The more complex Pre-market Approval (PMA) pathway, which is required for high-risk, novel Class III devices, remains a potential future hurdle for new, more advanced therapeutic platforms like drug delivery or chronic stimulation systems.

Intellectual property (IP) protection is vital against larger medical device competitors.

In the medical device space, your IP is your moat, especially when competing with giants like Medtronic or Boston Scientific. NeuroOne Medical Technologies Corporation's thin-film electrode technology is protected by a robust portfolio that includes 17 issued and pending patents in the U.S. and internationally as of July 2025. This is a defintely critical defense mechanism.

A recent and significant development was the notice of allowance received on July 23, 2025, for a key patent titled "Methods for Making Probe Devices and Related Devices." This patent specifically covers novel manufacturing methods and electrode material deposition techniques that are central to the company's competitive advantage. Protecting this IP is a continuous, high-cost legal effort, but it's essential to secure the long-term licensing revenue, like the payments received from the exclusive distribution agreement with Zimmer Biomet.

General Data Protection Regulation (GDPR) and HIPAA compliance for patient data are mandatory.

Handling patient data in the US means strict compliance with the Health Insurance Portability and Accountability Act (HIPAA), and any future international sales will mandate adherence to the European Union's General Data Protection Regulation (GDPR). The cost of failure here is staggering. The average cost of a healthcare data breach in the US, according to a 2025 report, was $7.42 million.

To prepare for international commercialization and the associated GDPR requirements, NeuroOne Medical Technologies Corporation has initiated the process to secure ISO 13485 certification. This certification, while not a legal requirement itself, demonstrates a robust quality management system that satisfies many of the regulatory demands for European market entry (CE Mark), which are intertwined with data protection standards.

The table below summarizes the core data privacy risks:

Product liability and malpractice risks are inherent in implantable devices.

As a manufacturer of implantable medical devices-electrodes and ablation systems used in the brain and spine-NeuroOne Medical Technologies Corporation carries a high inherent product liability risk. A single device failure or complication can trigger a costly lawsuit, regardless of the company's financial stability (which was debt-free as of December 31, 2024).

The entire Medical Professional Liability Insurance market is expanding, projected to grow to $24.34 billion by 2029, driven by an increase in medical malpractice claims. This market growth signals rising insurance premiums and higher litigation exposure for all medical device manufacturers. The company must maintain substantial product liability insurance coverage, and the cost of this coverage will increase as product revenue-projected to be between $8 million and $10 million in fiscal year 2025-and market penetration grow.

The risk is two-fold:

• Direct Liability: Claims from patients alleging a defect in the device design or manufacturing.
• Malpractice Claims: Being drawn into lawsuits against surgeons or hospitals where the device is implicated in a poor outcome.

The focus on quality control and rigorous testing, which also helps lower insurance premiums, is a non-negotiable action item here.

NeuroOne Medical Technologies Corporation (NMTC) - PESTLE Analysis: Environmental factors

You're tracking NeuroOne Medical Technologies Corporation's shift toward profitability, but the environmental factors-especially waste and supply chain resilience-remain an unquantified risk. The company's financial footing is more secure following the April 2025 capital raise of $8.2 million in net proceeds, which funds operations through at least fiscal 2026, but the core business model relies on single-use devices that create a persistent waste challenge.

Here's the quick math on your required check: Q1 fiscal 2025 operating expenses were $3.2 million. The recent capital raise provides a significant buffer, but continuous cash burn-totaling $9.5 million for the first nine months of fiscal 2025-means the environmental cost of goods sold needs to be managed for long-term sustainability, not just financial runway.

Need for sustainable manufacturing processes for single-use, disposable devices.

NeuroOne Medical Technologies Corporation's core products, such as the Evo sEEG and OneRF Ablation System, utilize thin-film electrode technology, which are designed for single-use, minimally invasive surgical procedures. This disposable model is standard in medtech for sterility and safety, but it directly conflicts with the rising pressure for environmental sustainability.

The challenge is manufacturing these high-precision, single-use devices with a lower environmental footprint. For a company focused on thin-film technology, this means scrutinizing the raw materials-polymers, metals, and packaging-for recyclability or bio-degradability. Right now, the focus is on performance and regulatory clearance, but investors are increasingly demanding a plan to reduce the life-cycle impact of these disposables. One clean one-liner: Single-use devices create a long-term waste liability.

Managing the biohazard waste stream generated by surgical products.

The use of NeuroOne's products in neurosurgical procedures, specifically for recording and ablation, classifies the used electrodes and probes as regulated medical waste (RMW), or biohazard waste. This waste stream is significantly more expensive and environmentally intensive to manage than general solid waste.

The average cost to dispose of RMW in the US is often 10 to 15 times higher than municipal waste, which directly impacts the operating expenses of the hospitals that are NeuroOne's customers. For a hospital, RMW disposal costs can easily exceed $1,000 per bed annually. NeuroOne does not directly manage the hospital's waste, but the volume and nature of its disposable products contribute to this burden, which can become a point of friction or a competitive disadvantage if rivals offer less-wasteful alternatives.

• Waste Type: Contaminated electrodes and surgical accessories.
• Disposal Method: Incineration or autoclaving, then landfill.
• Cost Risk: Increased disposal costs for customers could defintely slow adoption.

Supply chain vulnerability to climate-related disruptions affecting component delivery.

Supply chain resilience against climate events is a critical near-term risk, even for a domestic operation. NeuroOne Medical Technologies Corporation has stated its supply chain is 'entirely domestic'. While this mitigates geopolitical tariff risk, it does not eliminate climate-related disruption risk, especially in the US Southeast and Gulf Coast regions.

The 2024 closure of a major US manufacturing plant (Baxter International's North Cove facility) due to Hurricane Helene, which caused months-long shortages of critical IV fluids, demonstrated the fragility of single-site, domestic medical supply chains. NeuroOne must assess the physical climate risk of its key US-based component suppliers and contract manufacturers. A single, multi-week disruption could severely impact the company's ability to meet its projected fiscal year 2025 product revenue of $8.0 million to $10.0 million.

Focus on reducing the carbon footprint of medical device logistics and distribution.

Logistics and distribution contribute a substantial portion of the medical device industry's carbon emissions, mainly through air freight and refrigerated transport, though NeuroOne's thin-film products likely do not require refrigeration. Reducing this footprint is a growing expectation from large health systems seeking to lower their Scope 3 emissions (emissions from their supply chain).

Since NeuroOne's supply chain is domestic, the primary focus should be on optimizing ground transport and packaging efficiency. Shipping smaller, lighter thin-film electrodes is inherently less carbon-intensive than bulkier devices, but the total number of shipments to its distribution partner, Zimmer Biomet, still matters. Companies that fail to track and report their logistics emissions will face pushback from major institutional customers who have public environmental, social, and governance (ESG) targets.

• Actionable Step: Mandate a 15% reduction target in packaging volume by the end of fiscal 2026.
• Risk: Lack of ISO 14001 certification could be a barrier to securing large, environmentally-conscious hospital contracts.

Finance: Draft 13-week cash view by Friday, incorporating a 5% contingency for climate-related supply chain delays.