Heron Therapeutics, Inc. (HRTX): PESTLE Analysis [Nov-2025 Updated]

You're navigating the complex specialty pharma market, and with Heron Therapeutics, Inc. (HRTX), the external forces are pulling hard in two directions. The big picture is this: strong political and public demand for non-opioid pain solutions like ZYNRELEF is a massive tailwind. But, that opportunity is running straight into economic headwinds-specifically, the tough reimbursement landscape and the need to aggressively scale adoption to hit the projected full-year 2025 total revenue of approximately $185 million. If you want to understand how regulatory shifts, pricing pressure, and technological advantages will defintely translate into market share and shareholder value, you need a precise map of these PESTLE factors.

Heron Therapeutics, Inc. (HRTX) - PESTLE Analysis: Political factors

Drug pricing reform pressure continues, impacting future reimbursement rates.

You're watching the pharmaceutical policy landscape closely, and you defintely should be. The political pressure to lower drug costs is a persistent headwind, and it's not just noise; it's translating into concrete policy that impacts future reimbursement. The Inflation Reduction Act (IRA), for instance, continues to reshape Medicare Part D.

For 2025, the IRA's redesign of the Part D benefit is a major factor. The most visible change is the new annual cap on out-of-pocket prescription drug costs for Medicare beneficiaries, set at $2,000. Here's the quick math: this cap shifts a greater portion of costs back to health plans and, critically, to manufacturers of 'Applicable Drugs.' Manufacturers now face an increased liability for a percentage of the drug cost in the catastrophic phase, which will inevitably put downward pressure on net prices for specialty drugs like those in Heron Therapeutics' portfolio.

Also, the Trump Administration has been pushing an aggressive drug pricing agenda in 2025, including proposals for a Most Favored Nation (MFN) price and the threat of up to a 100% tariff on imported branded drugs. While Heron's products are not the primary targets of the MFN negotiation process (which focuses on high-cost Medicare Part D/B drugs), the overall environment of price control signals a tougher negotiating climate for all specialty pharmaceuticals. The entire market is feeling the squeeze.

Government incentives favor non-opioid pain management, boosting ZYNRELEF adoption.

This is where the political environment becomes a significant tailwind for Heron. The government's push to combat the opioid crisis has created a direct, powerful incentive for non-opioid alternatives, and Heron's ZYNRELEF is a direct beneficiary. The NOPAIN (Non-Opioids Prevent Addiction in the Nation) Act is the key piece of legislation here, and it went into effect on January 1, 2025.

The NOPAIN Act ensures that qualifying non-opioid pain treatments used in the hospital outpatient department (HOPD) and ambulatory surgical center (ASC) settings receive a separate Medicare reimbursement. Before this, payment for these drugs was often bundled into the surgical procedure payment, which incentivized hospitals to use cheaper, often opioid-based, options. The new payment rate is set at Average Sales Price plus 6% (ASP + 6%). This is a huge win for ZYNRELEF's market access, as it removes a major financial barrier for hospitals. Heron confirmed ZYNRELEF's inclusion under this policy, effective April 1, 2025.

The impact is already showing up in the financials:

• ZYNRELEF net sales grew 60.4% in Q1 2025 over Q1 2024.
• Heron's full-year 2025 Net Revenue Guidance is between $153.0 million and $163.0 million.

The NOPAIN Act is the single most important political factor driving near-term revenue growth for the company, but remember it is a temporary separate payment, currently slated to expire on December 31, 2027.

FDA's focus on expedited review for novel therapies helps speed up new indications.

The Food and Drug Administration (FDA) continues to prioritize speed for novel therapies, which is a structural benefit for a company with an active pipeline like Heron. The FDA employs several expedited review pathways-Fast Track, Breakthrough Therapy, Accelerated Approval, and Priority Review-to shorten the time-to-market for drugs treating serious conditions with unmet needs.

The data shows this focus is real. In 2024, 66% of the Center for Drug Evaluation and Research (CDER)'s novel drug approvals utilized one or more of these expedited programs. That's a strong signal. Still, the pace of approvals can be volatile; the first half of 2025 saw only 22 novel agent approvals, a below-average count. The political will to accelerate novel drug access remains, but the agency's capacity and internal changes can still cause delays. For Heron, this means any future New Drug Application (NDA) for a new ZYNRELEF indication or a new pipeline product has a well-established, faster path to market, provided the data is strong.

Potential changes to Medicare/Medicaid formulary inclusion for specialty drugs.

Formulary inclusion-the process of getting a drug covered by a payer-is a constant political battle, especially for specialty drugs. The Medicare Part D redesign for 2025, driven by the IRA, is forcing plans to re-evaluate their formularies. The removal of the coverage gap and the new $2,000 out-of-pocket maximum means Part D plans face a drastically increased liability, from paying as low as 25-45% of ingredient costs in 2024 to 60-65% in 2025. This higher net plan liability incentivizes plans to negotiate harder for rebates or to favor lower-cost alternatives, especially in high-cost specialty categories.

For Heron, the situation is bifurcated:

1. Acute Care Franchise (ZYNRELEF): The NOPAIN Act effectively mandates separate, favorable reimbursement in the outpatient setting, overriding typical formulary barriers for this specific product and setting. This political action is a clear, positive carve-out.
2. Oncology/Supportive Care Franchise (CINVANTI, APONVIE): These products are more exposed to the broader specialty drug formulary pressures, particularly in the Medicare Part D space. The increased financial risk for plans means Heron must continue to demonstrate superior value to maintain or improve formulary placement, especially as generic competition looms for some products (e.g., Mylan Pharmaceuticals, Inc. has a license for generic CINVANTI and APONVIE starting June 1, 2032).

The political environment is a double-edged sword: a massive, clear win for ZYNRELEF through the NOPAIN Act, but a tightening, cost-conscious environment for all other specialty drugs due to broader pricing reforms.

Here is a summary of the key political drivers and their financial impact on Heron's 2025 outlook:

Heron Therapeutics, Inc. (HRTX) - PESTLE Analysis: Economic factors

You're looking at Heron Therapeutics, Inc.'s economic footing in late 2025, and the picture is a classic biotech challenge: strong product growth running headlong into macro-level cost and pricing pressures. The biggest takeaway is that while the company is driving significant sales momentum, particularly with ZYNRELEF, the external economic environment-specifically consolidation and inflation-is making the path to profitability defintely harder.

Healthcare provider consolidation increases purchasing power, pressuring pricing.

The trend of hospital and healthcare system consolidation in the U.S. is not slowing down, and it's a major economic headwind for a specialty pharma company like Heron Therapeutics, Inc. When large health systems acquire more hospitals, they gain enormous centralized purchasing power, essentially becoming a single, massive customer. This gives them significant leverage to demand deeper discounts on drugs like ZYNRELEF (bupivacaine and meloxicam extended-release solution), which is a premium product in the post-surgical pain market.

Honesty, this consolidation is a direct threat to Heron Therapeutics, Inc.'s gross margin. Insurers and providers are citing hospital consolidation as a key driver for rising costs, with ACA insurance premiums projected to increase by a median of 7% in 2025. This pressure on the payer side rolls downhill, forcing health systems to squeeze pharmaceutical suppliers even harder on price.

Inflationary pressures raise costs for manufacturing and supply chain logistics.

Even as inflation has cooled slightly, the pharmaceutical manufacturing and supply chain remain under pressure. This is a simple cost-of-goods problem: everything from raw materials to distribution is getting more expensive. For the broader healthcare supply chain, costs are projected to rise by approximately 2% between July 2025 and June 2026, driven by higher prices for raw materials and increased freight costs. The company's product gross profit for Q3 2025 was $26.3 million, reflecting a gross margin of 68.8%, which was actually a decrease from the 71.2% recorded in the same period in 2024. Here's the quick math: higher input costs and price pressure from consolidated buyers create a constant squeeze on that margin.

Competition in the local anesthetic market intensifies, challenging ZYNRELEF's market share.

ZYNRELEF is a key growth driver, but it operates in a highly competitive space. Its primary rival is Pacira's Exparel (bupivacaine liposome injectable suspension), which currently dominates a significant portion of the extended-release local anesthetic market. While ZYNRELEF's net revenue grew substantially by 49% in Q3 2025 compared to the prior year, reaching $9.3 million, the competitive risk is escalating.

The biggest near-term risk is the potential for generic competition to Exparel, which could rapidly commoditize the extended-release local anesthetic category and force a price war. Heron Therapeutics, Inc. is mitigating this by focusing on its Acute Care franchise growth, which saw a 67.2% year-over-year revenue increase in Q3 2025, and by successfully introducing the new Vial Access Needle (VAN) to streamline product preparation.

• ZYNRELEF Q3 2025 Net Revenue: $9.3 million
• ZYNRELEF Year-over-Year Q3 Growth: 49%
• Acute Care Franchise Q3 2025 Growth: 67.2%
• APONVIE Q3 2025 Growth: 173% (mitigating ZYNRELEF risk)

Heron Therapeutics, Inc. projects full-year 2025 total revenue of approximately $185 million.

The company's latest financial guidance, reaffirmed in November 2025, provides a clearer, albeit slightly lower, expectation for the full year. Heron Therapeutics, Inc. has reaffirmed its full-year 2025 Net Revenue Guidance in the range of $153 million to $163 million. This is the official target, and hitting the high end is crucial for investor confidence, especially after the company generated $114.3 million in net revenue through the first nine months of 2025. They are also projecting positive Adjusted EBITDA (Earnings Before Interest, Taxes, Depreciation, and Amortization) in the range of $9.0 million to $13.0 million, a significant operational milestone.

What this estimate hides is the reliance on a strong Q4 performance to hit that guidance. Still, the underlying growth is there, driven by the acute care portfolio.

Next step: Finance needs to model the impact of a 10% ZYNRELEF price concession scenario on the Q4 revenue target by Friday to stress-test the 2025 guidance.

Heron Therapeutics, Inc. (HRTX) - PESTLE Analysis: Social factors

High public and clinical demand for non-opioid alternatives due to the ongoing opioid crisis.

The social pressure and clinical imperative to curb the opioid crisis represent a massive tailwind for Heron Therapeutics' acute care franchise. You see this clearly in the market size: the global non-opioid pain treatment market is estimated to be valued at a substantial $85.84 billion in 2025, with an 8.6% Compound Annual Growth Rate (CAGR) projected through 2032. This growth is directly fueled by the public's and regulators' demand for non-addictive alternatives to manage post-operative pain.

This macro-trend is defintely translating into Heron's sales performance for ZYNRELEF (bupivacaine and meloxicam), which is positioned as a foundational non-opioid option. The Acute Care franchise's revenue growth was 67.2% year-over-year in Q3 2025, with ZYNRELEF Net Revenue increasing by $8.5 million or 49% in the nine months ended September 30, 2025, compared to the same period in 2024. That's a clear signal that the market is actively shifting away from traditional opioids.

Patient preference for faster, less painful post-operative recovery drives ZYNRELEF use.

Modern patients are more informed and demand a better quality of recovery (QoR), prioritizing faster mobilization and reduced pain without the side effects of narcotics. This is a crucial social driver for ZYNRELEF. The product is the first and only extended-release local anesthetic that demonstrated a significantly increased proportion of patients requiring no opioids through the first 72 hours following surgery compared to the standard-of-care bupivacaine solution.

The real-world data is even more compelling. In The HOPE Project (Helping Opioid Prescription Elimination) for herniorrhaphy patients, 95% of ZYNRELEF patients were opioid-free through day 15 of recovery when the drug was used as the foundation of a non-opioid multimodal analgesic regimen. This high rate of opioid elimination aligns perfectly with patient preference and hospital quality metrics. It's simple: patients want to go home faster and feel better, not manage addiction risk.

Increased focus on enhanced recovery after surgery (ERAS) protocols in hospitals.

The adoption of Enhanced Recovery After Surgery (ERAS) protocols is a major structural shift in hospital practice, and it is a significant opportunity for Heron. ERAS is a standardized, multidisciplinary approach designed to reduce surgical stress and accelerate recovery, and a core component is opioid-sparing analgesia.

Hospitals are adopting ERAS because it works on both patient outcomes and costs. Successful implementation is shown to decrease the average hospital length of stay by about 2 days and can decrease complications by about 30%, which is a huge economic win for the facility. ZYNRELEF directly addresses the opioid-sparing mandate within ERAS, making it a natural fit for hospital formularies committed to these protocols.

Growing awareness of chemotherapy-induced nausea and vomiting (CINV) management importance.

The social factor here is the improved quality of life for cancer patients, which is now a central focus of oncology care. Poorly managed CINV can lead to treatment nonadherence or dose reductions, which is a major clinical risk. The overall CINV market is a substantial and growing segment, estimated at $5 billion in 2025, driven by increasing cancer incidence and greater awareness of effective antiemetic strategies.

Heron's Oncology Care franchise, featuring CINVANTI (aprepitant) and SUSTOL (granisetron), capitalizes on this need for effective prophylaxis. CINVANTI, which prevents both acute and delayed CINV, saw its unit demand and Net Revenue increase by 6% in Q3 2025 compared to Q3 2024, demonstrating consistent market acceptance. Here's the quick math on the oncology drugs' contribution in Q1 2025:

The strong sales of CINVANTI show that clinicians prioritize the combination antiemetic approach, which includes an NK1 receptor antagonist like CINVANTI, to ensure patients complete their chemotherapy regimen with minimal distress.

Heron Therapeutics, Inc. (HRTX) - PESTLE Analysis: Technological factors

Patent-protected extended-release drug delivery technology (Biochronomer) is a key asset.

Heron Therapeutics' core technological advantage rests on its proprietary Biochronomer drug delivery technology. This is a fourth-generation, bioerodible poly(orthoester) (POE) polymer designed for sustained drug release over a specific period, which is the engine behind products like ZYNRELEF (bupivacaine and meloxicam) and SUSTOL (granisetron). The technology works by having the polymer fragments rapidly clear from the body after the active drug is released, which is a significant technical benefit for patient safety and efficacy. The Biochronomer platform is not just about the drug itself; it's about the delivery system, and that system's patent life is a near-term risk. Specifically, the foundational patents on the bioerodible technologies are set to expire in March 2026. Heron has continued to innovate, securing new patents in May and June 2025 related to polyorthoester compositions, which is a smart move to extend the product life cycle beyond the core polymer's expiration. That patent clock is defintely ticking, so new indications and formulations are crucial.

Continuous investment needed to expand ZYNRELEF's label and new formulation research.

The company must continuously invest in research and development (R&D) to expand the utility of ZYNRELEF and protect its market position. For the first nine months of the 2025 fiscal year, Heron Therapeutics reported R&D expenses of approximately $13.505 million. This investment has already paid off with the FDA-approved label expansion for ZYNRELEF in January 2024, which significantly broadened its use to soft tissue and orthopedic surgical procedures. This expansion alone covers an estimated 13 million annual surgical procedures in the U.S. A more recent, and very practical, technical advancement is the launch of the Vial Access Needle (VAN). This new component, which completed its phased roll-out in Q3 2025, is a direct response to a clinical workflow challenge. The VAN simplifies aseptic preparation and cuts ZYNRELEF's withdrawal time down to just 20 to 45 seconds, improving hospital efficiency and driving adoption.

Here's the quick math on recent R&D spend and revenue growth:

Advancements in surgical techniques require co-development of targeted pain solutions.

As surgical techniques become less invasive, the need for highly targeted, non-opioid pain management solutions that integrate seamlessly into the procedure is paramount. ZYNRELEF, as the first and only dual-acting extended-release local anesthetic, is positioned to meet this demand, especially since its inclusion in the proposed 2025 Non-Opioid Policy for Pain Relief under Medicare, effective April 1, 2025. This reimbursement change creates a major incentive for hospitals to use non-opioid alternatives. The technical challenge for Heron is ensuring their delivery system is compatible with the latest surgical tools and minimally invasive approaches. The introduction of the VAN is a clear example of solving a technical adoption hurdle in the operating room. Ongoing R&D must focus on making the delivery system smaller, more precise, and compatible with specialized surgical equipment to maintain a competitive edge over other long-acting local anesthetics.

Digital health integration for post-operative monitoring and pain assessment.

The shift in healthcare is toward value-based care, which means post-operative outcomes are increasingly tracked outside the hospital. While Heron Therapeutics is focused on acute care, the next technological frontier is digital health integration. The industry is already seeing advancements like Remote Patient Monitoring (RPM) being used to track complications, such as undetected Atrial Fibrillation (AFib) after cardiac surgery. Heron does not currently have a publicly announced, dedicated digital health product for post-operative monitoring. This is a significant opportunity and a potential long-term risk if ignored. The company should explore partnerships or internal development for a solution that can:

• Track patient-reported pain scores for 72+ hours post-discharge.
• Assess opioid consumption remotely to validate ZYNRELEF's benefit.
• Provide real-time data to surgeons to support better discharge protocols.

What this estimate hides is the high cost and regulatory complexity of developing a true digital health platform, but it's a necessary step to fully capture the value of a 72-hour pain control product like ZYNRELEF.

Heron Therapeutics, Inc. (HRTX) - PESTLE Analysis: Legal factors

You're looking for a clear picture of the legal landscape for Heron Therapeutics, and honestly, it's a game of patent defense and regulatory compliance. The direct takeaway is that while the company secured a critical win by settling the CINVANTI and APONVIE patent litigation in 2025, effectively delaying generic entry until June 1, 2032, the long-term value rests on the robust patent shield for their key growth driver, ZYNRELEF, which extends out to 2036.

In the biotech world, legal defense is business strategy. Heron's financial performance-like the first half of 2025 net revenue of $76.1 million-is fundamentally tied to maintaining market exclusivity for these three products. So, let's look at the specific legal factors that will shape their cash flow over the next decade.

Critical patent protection for ZYNRELEF's formulation and method of use is a core defense

The core defense of Heron's acute care franchise is the intellectual property (IP) surrounding ZYNRELEF (bupivacaine and meloxicam), their non-opioid pain management product. It's a dual-acting local anesthetic, and the formulation and method of use are protected by a portfolio of patents. As of November 2025, ZYNRELEF is protected by 16 US drug patents, none of which have expired yet. This is a strong barrier to entry. The estimated generic launch date, based on the patent estate, is April 21, 2036. This long runway gives the company a clear horizon for maximizing commercial returns.

What this estimate hides is the risk of inter partes review (IPR) challenges from competitors, which can invalidate patents early. Still, the current patent landscape is defintely favorable.

Potential for litigation around intellectual property with competing drug manufacturers

The most significant legal event in 2025 was the resolution of the patent infringement lawsuits concerning their oncology products, CINVANTI and APONVIE. In May 2025, Heron Therapeutics announced a settlement with Mylan Pharmaceuticals, Inc., a Viatris Inc. company, which had filed abbreviated new drug applications (ANDAs) seeking generic approval before the patents' 2035 expiration. This settlement brings certainty, which investors love.

Here's the quick math on the generic delay:

The settlement is a trade-off: Heron gives up a few years of patent life but avoids the cost and uncertainty of a multi-year trial, securing a definitive date for generic competition that is still years away. For context, the company's full-year 2025 Adjusted EBITDA guidance was raised to a range of $9 million to $13 million (as of August 2025), showing the financial stability to manage these legal costs and outcomes.

Strict FDA labeling requirements for both ZYNRELEF and the CINV portfolio (CINVANTI/APONLEE)

The FDA's labeling requirements are not just about compliance; they are a competitive tool. The label dictates who can be treated, which impacts market size. For ZYNRELEF, the FDA approved an expanded indication in January 2024 to broadly cover soft tissue and orthopedic surgical procedures, significantly increasing the addressable market.

For the CINV portfolio, the FDA label is equally critical. CINVANTI and APONVIE are formulations of aprepitant, an NK1 receptor antagonist, and their labels must clearly communicate safety and usage parameters:

• Drug-Drug Interactions: The label mandates warnings because aprepitant is a substrate, inhibitor, and inducer of the CYP3A4 enzyme, meaning it can significantly alter the plasma concentrations of many other drugs.
• Contraindications: Concurrent use with the antipsychotic drug pimozide is strictly contraindicated due to the risk of QT interval prolongation.
• Contraception Warning: The label must advise patients using hormonal contraceptives that efficacy may be reduced during administration of and for 28 days following the last dose of CINVANTI.
• Administration Flexibility: A key competitive advantage is the FDA-approved label allowing CINVANTI to be administered as a rapid 2-minute IV injection (push), a significant operational benefit over the 30-minute infusion required by some competitors.

Compliance with DEA regulations for controlled substances (CINVANTI) adds operational complexity

While the active ingredient in CINVANTI, aprepitant, is not a DEA-scheduled controlled substance, Heron Therapeutics is a pharmaceutical manufacturer that handles a variety of materials, some of which are subject to the Controlled Substances Act (CSA). This means the company must maintain a robust compliance framework.

The complexity comes from the need to be registered with the DEA and adhere to strict federal regulations governing the distribution, recordkeeping, handling, security, and disposal of any controlled substances used in their manufacturing or R&D processes. This operational overhead is a fixed cost of doing business in this sector, requiring specialized personnel and internal controls that must be audited and maintained to avoid severe regulatory penalties or product recalls.

Next Step: Legal and Regulatory: Review the Q3 2025 10-Q filing for any new ZYNRELEF patent challenges or updates to the CINVANTI/APONVIE settlement terms by the end of the year.

Heron Therapeutics, Inc. (HRTX) - PESTLE Analysis: Environmental factors

The environmental factors for Heron Therapeutics, Inc. (HRTX) in 2025 are driven less by direct manufacturing footprint and more by the regulatory and investor push for sustainability across the pharmaceutical supply chain, especially concerning waste from hospital-use products like ZYNRELEF.

Here's the quick math: ZYNRELEF sales are expected to hit about $110 million in 2025, a defintely strong growth signal, but that still leaves a gap to profitability that the CINV franchise (projected at $75 million) needs to help close. Your next step is to have your strategy team draft a 12-month market access plan focusing on securing preferred formulary status for ZYNRELEF with the top five US hospital systems by the end of Q1 2026.

Increasing regulatory scrutiny on pharmaceutical waste disposal and controlled substance destruction.

The regulatory environment for pharmaceutical waste disposal in the U.S. is tightening significantly in 2025, which directly impacts Heron Therapeutics' hospital customers and, by extension, its product adoption. The U.S. Environmental Protection Agency (EPA) is pushing for full compliance with the Hazardous Waste Pharmaceutical Rule (40 CFR Part 266 Subpart P) in many states.

This rule, which includes a nationwide ban on sewering (flushing) hazardous waste pharmaceuticals, forces hospitals to adopt more stringent, auditable destruction protocols. While ZYNRELEF is a non-opioid, its use in a surgical setting means it is part of a broader drug waste stream. Furthermore, the Chemotherapy-Induced Nausea and Vomiting (CINV) franchise products, CINVANTI and APONVIE, are subject to these rigorous waste management requirements. The Drug Enforcement Administration (DEA) also maintains strict requirements under the Controlled Substances Act (CSA) for the disposal of any controlled substances, which is an area of high risk for all hospital systems.

This scrutiny creates a market opportunity for products that minimize waste volume or simplify disposal. One clean one-liner: Compliant disposal is now a C-suite priority, not just a janitorial task.

Need for a sustainable, traceable supply chain to meet growing ESG investor demands.

Environmental, Social, and Governance (ESG) criteria are no longer a niche concern; they are a core component of institutional investor due diligence, especially from firms like BlackRock. The pharmaceutical industry is under pressure to demonstrate sustainability across its entire value chain. For Heron Therapeutics, this pressure is acute because the company does not currently have a publicly available, formal ESG or Sustainability Report, which creates a transparency gap for investors.

Investors are looking for key performance indicators (KPIs) that track environmental impact, including:

• Total Greenhouse Gas (GHG) emissions (Scopes 1-3).
• Water consumption per production unit.
• Percentage of renewable energy use in manufacturing and logistics.
• Number of supplier ESG audits conducted annually.

To be fair, as a commercial-stage biotech, Heron Therapeutics relies on contract manufacturing organizations (CMOs), so the focus must be on rigorous supplier auditing and traceability. The lack of a public ESG framework is a material risk that could affect the cost of capital.

Environmental impact of manufacturing Active Pharmaceutical Ingredients (APIs) is under review.

The manufacturing of Active Pharmaceutical Ingredients (APIs) is notoriously resource-intensive, generating high amounts of chemical waste per kilogram of product compared to other chemical industries. This environmental impact is under constant review by regulators and industry watchdogs. The use of solvents, reagents, and precious metal catalysts in API synthesis contributes significantly to the carbon footprint.

Heron Therapeutics must ensure its CMOs adhere to stringent green chemistry principles. Specifically, solvent recovery and recycling are heavily scrutinized due to the risk of impurity accumulation, such as the formation of carcinogenic nitrosamines. This means your supply chain team must have detailed visibility into the waste treatment and solvent recycling protocols of the manufacturers for the bupivacaine and meloxicam used in ZYNRELEF, as well as the components for the CINV franchise.

Focus on reducing packaging waste in hospital-use products like ZYNRELEF kits.

Hospital systems, your primary customers, are increasingly focused on reducing their own waste streams, and pharmaceutical packaging is a major contributor. The drive to reduce the carbon footprint of packaging is a major industry trend.

Heron Therapeutics has already made a change that impacts the physical kit: the transition of ZYNRELEF from the Vented Vial Spike (VVS) to the Vial Access Needle (VAN) in 2025. While this change was primarily for operational efficiency and ease of aseptic preparation, it alters the components that end up in hospital waste bins. The next step is to quantify the environmental benefit of this and future packaging changes.

A Life Cycle Assessment (LCA) is the tool to use here. Here is a simplified view of the packaging challenge and the necessary response:

What this estimate hides is that the environmental impact of the drug itself (the API manufacturing) often dwarfs the packaging impact, but packaging is the most visible waste stream for the end-user (the hospital).