What changed in this filing

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Item 1. Business

2026-03-03 compared with 2025-03-17 · 93 added, 92 removed, 316 unchanged (37% of the section changed)

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Anika ’ s Mission:

“Powered by our passionate team, we partner with clinicians to create and provide meaningful advancements in early intervention orthopedic care.

We are unwavering in our commitment to quality and compliance as we develop and commercialize solutions that restore active living for people around the world.”

“Together, we restore active living and redefine what’s possible with hyaluronic acid.”

Anika ’ s Core Values:

We engage with and invest in each other in a community that values diversity and inclusion.

We strive for the highest quality and compliance in everything we do.

We live up to our promises and do the right thing, every day.

We are agile and entrepreneurial in developing and delivering meaningful solutions.

We operate with mutual respect and trust and are collaborative as we grow together.

Accountability:

We are empowered and accountable to deliver results and value to all our stakeholders.

Trust and Respect:

We build trust and show respect in every interaction.

We are committed to quality as we work to improve people’s lives.

Empowerment & Teamwork:

We are empowered as a team to make decisions that drive impact.

We focus on what matters most and are driven to be better every day.

In October 2024, we announced a strategic shift to concentrate on our OA Pain Management and Regenerative Solutions portfolios.

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We will place particular emphasis on the commercial execution and adoption of the newest product in our Regenerative Solutions portfolio, the Integrity Implant System (“Integrity”), a HA-based scaffold designed for rotator cuff and other tendon repairs.

The Integrity system has shown strong performance, with over 40% sequential growth in surgeries and significant adoption by new customers.

We will continue to invest in our Regenerative Solutions R&D pipeline as we prepare for the U.S.

The Integrity system has shown strong performance, with continuing growth in surgeries and significant adoption by new customers.

We will continue to invest in our Regenerative Solutions R&D pipeline as we prepare for the potential U.S.

approval and launch of both Hyalofast and Cingal, each representing an incremental U.S.

addressable market of at least $1 billion.

Hyalofast is on track for a U.S.

launch by 2026, and we have submitted the first two modules of our premarket approval (“PMA”) application with the FDA.

We submitted our premarket approval (“PMA”) application with the FDA for Hyalofast on October 31, 2025.

We received a letter from the FDA in January 2026 in which the FDA identified a number of deficiencies in which we are preparing our response.

Additionally, we will build on the international commercial momentum of our entire OA Pain Management portfolio, led by Monovisc and Cingal.

Cingal has shown significant clinical success and is progressing towards a New Drug Application (“NDA”) filing in the U.S.

Cingal has shown significant clinical success and we have been actively engaging with the FDA on next steps for regulatory approval in the U.S.

On October 31, 2024 (the “Arthrosurface Closing Date”), we completed the sale of all outstanding equity interests (the “Arthrosurface Transaction”) of Arthrosurface Incorporated, a Delaware corporation and former wholly-owned subsidiary of the Company (“Arthrosurface”), which held our Arthrosurface asset group, to Phoenix Brio, Incorporated, a Delaware corporation (“Phoenix Brio”), pursuant to the terms and conditions of a Share Purchase Agreement, dated as of the Arthrosurface Closing Date (the “Arthrosurface Purchase Agreement”), by and amongst us, Arthrosurface, and Phoenix Brio.

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Products and Services

Anika provides a broad array of products and services, including:

We provide a broad array of products and services, including:

Osteoarthritis ( “ OA ” ) Pain Management :

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Our OA Pain Management products are generally administered to patients in an office setting.

In the United States, Monovisc and Orthovisc are marketed exclusively by J&J MedTech.

In the United States, Monovisc and Orthovisc are marketed exclusively by Johnson & Johnson MedTech (“J&J MedTech”).

In December 2011, we entered into a fifteen-year licensing agreement with J&J MedTech to exclusively market Monovisc in the United States through December 2026.

On October 16, 2025, J&J MedTech extended the agreement to exclusively market Monovisc in the United States through December 2031.

In December 2003, we entered into a ten-year licensing agreement to exclusively market Orthovisc in the United States.

J&J MedTech extended this agreement for additional five-year terms in 2007, 2012, 2017, and most recently in August 2022.

The current agreement expires in December 2028 unless extended at the option of J&J MedTech.

J&J MedTech has subsequently extended this agreement, and most recently from August 2022 through December 2028.

These licensing agreements of Monovisc and Orthovisc can be extended at the option of J&J MedTech.

Monovisc and Orthovisc have been market leaders, based on combined overall revenue in the viscosupplement market, since 2018.

Despite recent competitive pricing pressures and reduced market access, Monovisc and Orthovisc remain market leaders in the U.S.

OA Pain Management market.

Despite recent competitive pricing pressures and reduced market access, Monovisc and Orthovisc remain market leaders in the United States OA Pain Management market.

Internationally, we market our OA Pain Management products directly through a worldwide network of commercial distributors, and our international sales team has successfully expanded into new countries, driving double-digit growth in recent years.

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We also received confirmation that the clinical data for Cingal is a review issue and not a filing issue.

Additionally, in September 2024, we acquired the Aristospan NDA, which allowed us to address a recent FDA requirement and will enable us to source the reference drug for a bioequivalence study.

We had another Type-C meeting with the FDA in February 2025 to discuss finalizing NDA submission requirements.

Additionally, in September 2024, we acquired the Aristospan New Drug Application (“NDA”), which allowed us to address a recent FDA requirement and will enable us to source the reference drug for a bioequivalence study.

In April 2025, we subsequently sold the Aristospan NDA to a third party manufacturer who will supply the reference drug for the bioequivalence study.

We had another Type-C meeting with the FDA in February 2025 to discuss finalizing NDA submission requirements, including bioequivalence study requirements.

The preclinical and bioequivalence studies have been initiated..

We are committed to bringing this revolutionary pain management therapy to the approximate $1 billion U.S.

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Integrity received FDA clearance for commercial use in the United States in August 2023 and we initiated a limited market release in November 2023.

Since its launch, Integrity has shown strong performance, with over 40% sequential growth in surgeries and significant adoption by new customers.

Since its launch, Integrity has shown strong performance, with continuing growth in surgeries and significant adoption by new customers.

The system competes in a U.S.

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In the United States, Hyalofast is a pipeline product under a pivotal Investigational Device Exemption (“IDE”) clinical trial and is not available for commercial sale.

We have filed the first and second modules of its PMA with the FDA, and the product is on track for a U.S.

launch by 2026.

We submitted a PMA on October 31, 2025 with the FDA, and we are targeting a U.S.

launch by 2027, pending approval from the FDA.

For additional information, please see the section captioned “Item 1.

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As a result of these distinctions, we employ multiple sales models in the United States to ensure that we meet the needs of our customers and other healthcare system stakeholders.

For many years, we have maintained a mutually beneficial commercial partnership with J&J MedTech, which sells Monovisc and Orthovisc in the United States.

In this arrangement, we sell the Monovisc and Orthovisc products that we manufacture to J&J MedTech, and we also receive a royalty from J&J MedTech on their end-user sales of these products in the United States.

For many years, we have maintained a mutually beneficial commercial partnership with J&J MedTech.

Pursuant to our contracts with J&J MedTech, we are the exclusive supplier responsible for the manufacture and sale Monovisc and Orthovisc to J&J MedTech in the United States, while J&J MedTech is responsible for the marketing, sales and distribution to end user customers in the United States.

commercial partnerships for other products in our Non-Orthopedic product families.

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For 2025, 2024, and 2023, research and development expenses were $25.8 million, $25.5 million, and $21.8 million, respectively.

The increase in 2024 was primarily due to costs associated with ensuring compliance with growing global regulatory requirements, such as the European Union (“EU”) Medical Device Regulation (“MDR”), as well as new product development in our research and development pipeline.

This pipeline is led by Integrity, which received FDA clearance in August 2023 and was launched with first surgeries in rotator cuff repair and other tendon procedures in November 2023.

We anticipate continuing to commit resources to research and development activities, primarily for new product development, regulatory compliance, scale-up manufacturing activities, and preclinical and clinical activities.

The increase in 2025 was primarily due to costs associated with increased spending on Cingal U.S.

regulatory submission activities and our Integrity clinical study, as well as ensuring compliance with growing global regulatory requirements, such as the European Union (“EU”) Medical Device Regulation (“MDR”) and new product development initiatives.

Our new product development efforts focus on HA-based products in unmet, large, and growing orthopedic markets to drive long-term value, specifically in OA Pain Management and Regenerative Solutions.

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As we move forward, we plan to continue investing in novel and meaningful new products for our target markets based on our core capabilities, including further expanding our regenerative HA technology platform.

Our development focus for OA Pain Management will continue to be on bringing Cingal, our next-generation, non-opioid, single-injection OA pain product combined with a fast-acting steroid, to the U.S.

Our development focus for OA Pain Management will continue to be on targeting to bring Cingal, our next-generation, non-opioid, single-injection OA pain product combined with a fast-acting steroid, to the U.S.

In 2022, we completed a third Phase III clinical trial for Cingal, which achieved its primary endpoint.

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regulatory approval.

In September 2024, we acquired the Aristospan NDA to assist with our Cingal regulatory filing with the FDA.

We have made significant progress in addressing the FDA's requirements for Cingal's approval, including a Type-C meeting with the FDA and acquiring the Aristospan NDA to enable us to source the reference drug for a bioequivalence study.

We had another Type-C meeting with the FDA in February 2025 to discuss finalizing NDA submission requirements.

We have made significant progress in addressing the FDA's requirements for Cingal's approval.

This includes having numerous meetings with the FDA to discuss finalizing NDA submission requirements and starting a bioequivalence study in 2025.

In parallel, we are exploring the potential to advance Cingal through commercial partnerships in the U.S.

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We are developing novel solutions and line extensions across our regenerative solutions segments, with a key focus on the shoulder, knee, and foot and ankle.

These include enhancements to existing regenerative solutions such as our Tactoset Injectable Bone Substitute, which received an additional premarket notification (510(k)) clearance in 2021 for hardware augmentation, and our Integrity Implant System, a regenerative HA-based patch product targeted at rotator cuff repair that received 510(k) clearance in August 2023 and is now in full market release.

Integrity has shown strong performance, with over 40% sequential growth in surgeries and significant adoption by new customers.

These include enhancements to existing regenerative solutions such as our Tactoset Injectable Bone Substitute for hardware augmentation, our Integrity Implant System, a regenerative HA-based patch product targeted at rotator cuff repair that received 510(k) clearance in August 2023 and is now in full market release.

Integrity has shown strong performance, with strong growth in surgeries and significant adoption by new customers.

In addition, we have made significant progress on a full regenerative pipeline, leveraging the commercial success of Integrity, as well as progress on our clinical trial to support approval in the United States for Hyalofast, our single-stage, off-the-shelf cartilage repair therapy, currently sold only outside the United States.

We have fully enrolled the 200 patients targeted in the Hyalofast trial.

This pivotal trial has a two-year follow-up protocol expected to be completed in early 2025 before regulatory submission is finalized.

We filed the first module as part of a modular PMA in 2024, which is the first step in seeking FDA approval for Hyalofast in the United States, and the second module was filed in January 2025.

The final module of the PMA will be filed in 2025 once the clinical data becomes available for submission to the FDA.

In early 2023, we completed enrollment of 200 patients in our U.S.

pivotal FastTRACK Phase III clinical trial evaluating Hyalofast, a single-stage, hyaluronic acid-based scaffold for cartilage repair.

This clinical trial had a two-year follow-up protocol.

We used a modular PMA filing process for our regulatory submission to the FDA for approval of Hyalofast in the U.S.

In July 2025, we received topline results from the study and Hyalofast did not achieve significance on its pre-specified co-primary endpoints for pain and function.

Although the study did not meet its co-primary endpoints, Hyalofast demonstrated consistent improvements over microfracture across all measures of pain and function, Sports and Recreation Function and Quality of Life and other measures including Total Knee Injury and Osteoarthritis and Outcomes Score.

The statistical analysis was impacted by both a disproportionately higher subject dropout rate in the microfracture arm and missed visits due to COVID.

Based on the strength and consistency of the overall data and the positive real-world clinical experience including data from multiple independent studies outside the U.S.

over the past 15 years, we submitted the final PMA module to the FDA on October 31, 2025.

As expected, we received in January 2026 a deficiency letter from the FDA informing us that the Hyalofast PMA lacks information needed to complete its review.

Among other things, the letter addressed matters related to chemistry, manufacturing and controls (CMC) and the statistical analysis plan for both primary and secondary endpoints and whether any of these endpoints achieved statistical significance.

We plan to continue to engage with the FDA to explore potential approaches to address the FDA’s concerns so that it might complete its review.

Although there can be no assurance that we will be able to fully address the FDA’s concerns, we continue to believe the totality of evidence presented in this study and the data from outside the United Sates demonstrates the clinical value of Hyalofast.

Intellectual Property

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Additionally, many of our competitors compete with us for collaborations in research and development, clinical trial, and commercialization programs.

We primarily compete with other market participants on the efficacy and safety reputation of our products, as well as the breadth of our overall product portfolio.

We primarily compete with other market participants on the efficacy and safety of our products, as well as the breadth of our overall product portfolio.

Other competitive factors include the timing and scope of regulatory approvals, availability of manufacturing supplies and raw materials, marketing and sales capabilities, reimbursement coverage, product pricing, and patent protection.

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If these market makers demand significant price concessions or exclude us as a supplier, our product revenue could be adversely impacted.

Despite these challenges, our products, like Monovisc, Orthovisc, and Cingal, have maintained strong market positions due to their clinical efficacy and safety profiles.

Despite these challenges, many of our products, such as Monovisc, Orthovisc, and Cingal, have maintained strong market positions due to their clinical efficacy and safety profiles.

Our regenerative solutions, including Integrity and Hyalofast, are also gaining traction, supported by robust clinical data and innovative technology.

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Governmental Regulation

The clinical development, manufacturing, and marketing of our products are subject to governmental regulation in the United States, the European Union, and other territories worldwide, including under the Federal Food, Drug, and Cosmetic Act (“FDCA”) in the United States.

The clinical development, manufacturing, and marketing of our products are subject to governmental regulation in the United States, the EU, and other territories worldwide, including under the Federal Food, Drug, and Cosmetic Act (“FDCA”) in the United States.

Medical products regulated by the FDA and other authorities are generally classified as drugs, biologics, or medical devices.

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An advisory committee of external experts may review the application and provide recommendations to the FDA.

The FDA generally conducts a pre-approval inspection of the manufacturing facilities to ensure compliance with the FDA’s quality system regulation (“QSR”).

The FDA generally conducts a pre-approval inspection of the manufacturing facilities to ensure compliance with the FDA’s quality management system regulation (“QMSR”).

The FDA will approve the device for commercial distribution if the data and information in the PMA constitute valid scientific evidence and provide reasonable assurance of the device’s safety and effectiveness.

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Regulation of a Drug

New drugs require FDA approval of a NDA to be marketed.

New drugs require FDA approval of an NDA to be marketed.

The approval process typically takes several years and varies based on the product’s type, complexity, and novelty.

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This includes requirements for monitoring, record-keeping, advertising and promotion, reporting adverse experiences, and limitations on industry-sponsored scientific and educational activities.

FDA regulations mandate that PMA and NDA approved products be manufactured in specific facilities, and all devices and drugs must comply with the QSR and cGMP regulations, respectively.

On February 2, 2024, the FDA published a final rule to amend its QSR requirements to align more closely with international consensus standards for medical devices by incorporating the 2016 edition of the ISO 13485 standard.

This amended regulation, known as the Quality Management System Regulation, will be effective February 2, 2026.

FDA regulations mandate that PMA and NDA approved products be manufactured in specific facilities, and all devices and drugs must comply with the QMSR and cGMP regulations, respectively.

Manufacturers and other entities involved in the manufacture and distribution of cleared or approved devices or drugs must register their establishments and list their products with the FDA and certain state agencies.

These manufacturers are subject to periodic announced and unannounced inspections by the FDA and state agencies to ensure compliance with regulatory requirements.

Discovery of violative conditions, including failure to conform to QSR and cGMP regulations, could result in enforcement actions.

Discovery of violative conditions, including failure to conform to QMSR and cGMP regulations, could result in enforcement actions.

Products may only be promoted for the cleared or approved indications and in accordance with the label provisions.

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EU Regulation

In the European Union, medical devices must be CE marked to be marketed.

CE marking involves working with a notified body (or self-certifying for low-risk devices) to demonstrate that the device meets all applicable general safety and performance requirements of EU medical devices legislation, including compliance with the manufacturer’s Quality Management System.

In the EU, medical devices must be CE marked to be marketed.

CE marking involves working with a notified body (or self-certifying for certain low-risk, Class I devices) to demonstrate that the device meets all applicable general safety and performance requirements of EU medical devices legislation, including compliance with the manufacturer’s Quality Management System.

The EU’s Medical Devices Directive (“MDD”) has been replaced by the EU Medical Devices Regulation (“EU MDR”), effective May 26, 2021.

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These conditions include compliance with EU MDR requirements for post-market surveillance, vigilance, and registration, having a contract with an EU MDR notified body before September 26, 2024, and filing an agreement for conformity assessment by May 26, 2024.

The EU also removed its 12-month "sell-off" provision, allowing non-transitioning medical devices that comply with the MDD to be supplied in the EU after May 2025 until stock is depleted.

The EU MDR generally requires increased levels of clinical data compared to MDD requirements, and all product technical data must comply with the latest standards regardless of when the product was initially developed.

Drug approval in the European Union follows one of several processes:

(i) a centralized procedure involving the European Medicines Agency’s Committee for Medicinal Products for Human Use;

Drug approval in the EU follows one of several processes:

(i) a centralized procedure, involving a scientific opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (“CHMP”), with the marketing authorization granted by the European Commission;

(ii) a mutual recognition procedure, where an individual country's regulatory agency approves the product, followed by mutual recognition by other countries' regulatory agencies;

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UK Regulation

The UK formally left the EU on January 31, 2020.

The EU and the UK concluded a Trade and Cooperation Agreement (“TCA”), provisionally applicable since January 1, 2021, and formally applicable since May 1, 2021.

The TCA includes specific provisions concerning pharmaceuticals, such as the mutual recognition of GMP inspections and GMP documents but does not provide for wholesale mutual recognition of UK and EU pharmaceutical regulations.

Currently, the UK has implemented EU legislation on the marketing, promotion, and sale of medicinal products through the Human Medicines Regulations 2012 (as amended), with the Medicines and Healthcare products Regulatory Agency (“MHRA”) responsible for authorizing all medicinal products.

While the UK regulatory regime aligns with EU regulations in many ways, it is possible that these regimes will diverge more significantly in the future now that the UK’s regulatory system is independent from the EU.

As of January 1, 2021, the Medicines and Healthcare products Regulatory Agency (“MHRA”) is the UK’s standalone medicines and medical devices regulator.

On January 1, 2025, a new arrangement called the “Windsor Framework” came into effect and reintegrated Northern Ireland under the regulatory authority of the MHRA with respect to medicinal products.

The Windsor Framework removes EU licensing processes and EU labeling and serialization requirements in relation to Northern Ireland and introduces a UK-wide licensing process for medicines.

In order to obtain a UK marketing authorization to commercialize products in the UK, an applicant must follow one of the UK national authorization procedures or one of the remaining post-Brexit international cooperation procedures.

The MHRA has introduced changes to national licensing procedures, including procedures to prioritize access to new medicines that will benefit patients, a 150-day assessment (subject to clock-stops) and a rolling review procedure.

In addition, since January 1, 2024, the MHRA introduced the International Recognition Procedure (“IRP”), which enables the MHRA when reviewing certain types of marketing authorization applications to take into account the expertise and decision-making of trusted regulatory partners, including the EMA.

Regarding medical devices, since the end of the Brexit transitional period on January 1, 2021, new regulations require medical devices to be registered with the MHRA before being placed on the Great Britain market.

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Manufacturers may choose to use the UKCA mark voluntarily before these dates.

However, the UKCA mark will not be recognized in the EU.

However, the UKCA mark is not recognized in the EU.

The EU regulatory framework for medical devices continues to apply in Northern Ireland under the Northern Ireland Protocol.

Medical devices in Northern Ireland may carry either an EU CE mark or a UK and Northern Ireland CE mark (“CE UKNI”), although devices bearing the CE UKNI marking will not be accepted on the EU market.

Medical devices placed on the Northern Ireland market generally require CE marking under EU rules;

where a UK Approved Body is used for mandatory third-party conformity assessment for the Northern Ireland market, the device must bear CE UKNI, although devices bearing the CE UKNI marking will not be accepted on the EU market.

Other Health Care Laws

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Rules and regulations regarding reimbursement change frequently, often on short notice.

In the United States, our products are administered by healthcare providers and reimbursed under a “buy-and-bill” model, pursuant to which providers purchase the product and seek reimbursement from third-party payers.

Under this model, providers bear inventory, billing, and reimbursement risk, and may be sensitive to reimbursement levels, payment timing, claims denials, and administrative requirements imposed by payers.

Even where coverage is available, third-party payers may impose prior authorization, step therapy, site-of-care restrictions, or other utilization management requirements, or may delay, deny, or reduce payment based on administrative, technical, or documentation-related reasons.

These practices may discourage provider adoption or reduce utilization of our products.

government, state legislatures, and foreign governments continue to implement cost-containment programs, including price controls, coverage and reimbursement restrictions, and generic substitution requirements.

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For example, the Further Consolidated Appropriations Act, 2020, repealed the Cadillac tax, the health insurance provider tax, and the medical device excise tax.

It is impossible to determine how future healthcare reform measures or efforts to challenge, repeal, or replace the ACA will impact our business.

It is impossible to determine how future healthcare reform measures, including changes affecting Medicare reimbursement, utilization management, site-of-care policies, or drug pricing and payment methodologies, will impact our business.

Data Privacy and Security Laws

We are also subject to various laws and regulations concerning data privacy in the United States, Europe, and elsewhere, including the General Data Protection Regulation (“GDPR”), in the European Union and the United Kingdom.

These legal requirements impose stringent requirements on the processing, administration, security, and confidentiality of personal data and empower enforcement agencies to impose large penalties for noncompliance.

We are also subject to various laws and regulations concerning data privacy in the United States, Europe, and elsewhere, including Section 5(a) of the Federal Trade Commission Act, U.S.

state consumer privacy laws, state breach notification laws, rules restricting the transfer of sensitive personal data, and comprehensive privacy and data protection laws, in the EU and the United Kingdom, including the General Data Protection Regulation (“GDPR”).

These laws and regulations impose stringent requirements on the processing, administration, security, and confidentiality of personal data and empower enforcement agencies to impose large penalties for noncompliance.

In addition, various jurisdictions around the world continue to propose new laws that regulate the privacy and/or security of certain types of personal data.

Complying with these laws, if enacted, would require significant resources and leave us vulnerable to possible fines, penalties, litigation, and reputational harm if we are unable to comply.

Complying with these laws and regulations, requires us to devote significant resources.

Any failure or perceived failure to comply with them may subject us to fines, penalties, litigation, reputational harm, and may also require us to change our data processing strategies.

Environmental Laws

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Environmental, Social and Governance

In 2021, we began a process to develop a foundational Environmental, Social and Governance (“ESG”) framework for our organization.

This framework integrates our six key corporate values:

People, Quality, Integrity, Accountability, Innovation and Teamwork.

The initial step in our ESG journey included the completion of a “materiality assessment” based on the Sustainability Accounting Standards Board (“SASB”) framework.

Our materiality assessment was a research-intensive and stakeholder-inclusive process and included guidance and insight from external advisors, and crucial feedback from key internal and external stakeholders, including investors, customers, suppliers, employees, and our board of directors.

As a result of the materiality assessment, we identified the themes that are most important to our stakeholders and our business within traditional environmental, social and governance pillars.

Most immediately, our materiality assessment enabled us to select our six key focus areas, with a goal to be aligned with SASB standards for the medical device industry.

We will continue to assess and update our ESG initiatives as our business grows and as we implement processes and improvements over time.

In 2021, we began building a foundational Environmental, Social and Governance (“ESG”) framework guided by our corporate values.

We completed a Sustainability Accounting Standards Board (“SASB”)-based materiality assessment that incorporated input from advisors and key stakeholders.

This process identified the ESG topics most significant to our business and led to the selection of six initial focus areas aligned with SASB standards for the medical device industry.

We plan to review and update our ESG efforts as needed over time.

Human Capital Management

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Our culture is centered around our fundamental values of:

We engage and invest in each other in a community that values diversity and inclusion.

We are agile and entrepreneurial in developing and delivering meaningful solutions to our healthcare stakeholders within our target markets.

We strive for the highest quality and compliance in everything we do.

We operate with mutual respect and trust and are collaborative as we grow together.

We live up to our promises and do the right thing, every day.

Accountability :

We are empowered and accountable to deliver results and value to all of our stakeholders.

Trust and Respect :

We build trust and show respect in every interaction.

We are committed to quality as we work to improve people’s lives.

Empowerment & Teamwork :

We are empowered as a team to make decisions that drive impact.

We focus on what matters most and are driven to be better every day.

Talent Acquisition and Management

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We believe that our employees’ understanding of how their work contributes to our overall strategy and performance is key to our success.

To communicate these important topics engagingly, we utilize various channels, including all-employee town hall meetings led by senior management, company-wide information sessions known as Knowledge Boosters, and regular email and intranet updates from our CEO and other key executives.

Additionally, we conduct company-wide employee engagement surveys using an external platform to assess perceptions in areas such as inclusion, professional development, reward/recognition, equity, engagement, and overall satisfaction.

Our management team evaluates the results, compares them with prior periods and peer data, and identifies potential improvement opportunities.

To communicate these important topics engagingly, we utilize various channels, including all-employee town hall meetings led by senior management through regular email and intranet updates from our CEO and other key executives.

We also monitor voluntary turnover as compared to national and industry benchmarks and evaluate improvement opportunities through exit and stay interviews.

Diversity, Equity and Inclusion

We are committed to a diverse, equitable, and inclusive workplace where all employees, regardless of gender, race, ethnicity, national origin, age, sexual orientation or identity, education, or disability, are valued, respected, and supported.

Beginning in 2021, we committed to key elements of the MassBio CEO Pledge for a More Equitable and Inclusive Life Science Industry.

We continue to work on a multi-year approach to meet our commitment, including developing and communicating a corporate Diversity, Equity, and Inclusion Policy Statement and creating a Diversity Dashboard.

The Diversity Dashboard tracks current diversity within the organization and is shared with the board of directors for engagement and oversight.

We have also conducted employee surveys and focus groups to discuss diversity and inclusion.

We will continue to enhance workforce diversity through focused talent acquisition goals and development plans.

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We have established safety policies and protocols and regularly update employees on any changes.

We have adjusted attendance policies to encourage those who may be ill to stay home.

To further protect on-site employees, we provide personal protective equipment and cleaning supplies.

We also provide general information updates and support to ensure employees have the resources and information to protect their health and that of their families and co-workers.

To further protect on-site employees, we invest resources for environmental, health and safety, conduct regular safety training for our employees and provide personal protective equipment and cleaning supplies.

Product Liability

The testing, marketing, and sale of human health care products entail an inherent risk of allegations of product liability, and we cannot assure that substantial product liability claims will not be asserted against us.

Although we have not received any material product liability claims to date, we cannot assure that if material claims arise in the future, our insurance will be adequate to cover all situations.

Moreover, we cannot assure that such insurance, or additional insurance, if required, will be available in the future or, if available, will be available on commercially reasonable terms.

Although we have not received any material product liability claims to date, we cannot be sure that if material claims arise in the future, our insurance will be adequate to cover all situations.

Moreover, we cannot be sure that such insurance, or additional insurance, if required, will be available in the future or, if available, will be available on commercially reasonable terms.

Any product liability claim, if successful, could have a material adverse effect on our business, financial condition, and results of operations.

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business