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Anika Therapeutics, Inc.

For the period ended Mar 31, 2026. Filed Apr 30, 2026.

View on SEC.gov

About this filing

A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.

Mar 31, 2026 · Filed Apr 30, 2026

ANIK$14.55-24.7%Stored close · as of Nov 6, 2026

What changed in Management’s Discussion and Analysis?

Read the current filing

Previous report: 10-Q

Period ended 2025-09-30; filed 2025-11-05.

0001171843-25-007032

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

Current report: 10-Q

Period ended 2026-03-31; filed 2026-04-30.

0001171843-26-002852

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

The baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.

Compared 71 previous paragraphs and 61 current paragraphs.

28 unchanged; 20 reworded; 13 added; 23 removed; 0 previous and 0 current paragraphs rearranged.

Tables are not compared: 21 previous and 19 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.

A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.

Added paragraphs (13)

Current report

We are a global leader in the design, development, manufacturing, and commercialization of hyaluronic acid, or HA innovations. In partnership with clinicians, our sole focus is dedicated to delivering and advancing osteoarthritis, or OA pain management, and orthopedic regenerative solutions. At our core is a passion to deliver a differentiated portfolio that improves patient outcomes around the world.

Current report

Three Months Ended March 31, 2026, Compared to Three Months Ended March 31, 2025

Current report

Revenue for the three-month period ended March 31, 2026, was $29.6 million, an increase of $3.4 million, or 13%, compared to the same period in 2025. The increase in revenue was driven by higher sales activity with our Original Equipment Manufacturer, or OEM Channel partners, primarily J&J MedTech and certain non-orthopedic products as well as higher Integrity revenues and international OA Pain Management revenues.

Current report

Revenue from our OEM Channel product family increased by 14% for the three-month period ended March 31, 2026, as compared to the same period in 2025. For the three-month period ended March 31, 2026, the $2.1 million increase was driven by a $1.0 million increase in J&J MedTech revenue and a $1.1 million increase in non-orthopedic revenue. The J&J MedTech revenue increase was primarily due to $2.8 million increase in sales volume, offset by a $1.8 million decrease due to lower pricing. The non-orthopedic increase was due to a $1.5 million increase in the timing of veterinary product sales offset by a $0.4 million decrease in ophthalmic and wound care revenues.

Current report

Revenue from our Commercial Channel product family increased 12% for the three-month period ended March 31, 2026, as compared to the same period in 2025. For the three-month period ended March 31, 2026, the $1.3 million increase was driven by a $0.7 million increase in international OA pain management revenues and a $0.6 million increase in regenerative revenue. The international OA pain management revenue increase was due to higher Monovisc and Cingal product sales offset by lower Orthovisc product sales. The regenerative revenue increase was due to higher Integrity and Hyalofast product sales offset by lower Tactoset revenues.

Current report

Gross profit for the three-month period ended March 31, 2026, increased $4.3 million to $19.0 million, representing a 64% gross margin for the period as compared to 56% in the prior year period. The increase in gross profit for the three-month period ended March 31, 2026, as compared to the same period in 2025, primarily resulted from higher sales activity. Gross margin for the three-month period ended March 31, 2026, increased compared to the same period of prior year due to higher sales activity, increased production volume and lower inventory reserves and scrap.

Current report

Research and development expenses for the three-month period ended March 31, 2026, were $6.7 million, an increase of $0.7 million as compared to the same period in 2025. This is primarily due to increased spending on the Cingal clinical study and headcount.

Current report

Selling, general and administrative expenses for the three-month period ended March 31, 2026, were $17.8 million, an increase of $4.9 million, as compared to the same period in 2025. The increase for the three-month period ended March 31, 2026, was primarily driven by a $3.3 million increase in stock-based compensation and $1.6 million in severance costs associated with our restructuring strategy.

Current report

For the three-month period ended March 31, 2026, the loss from continuing operations was $5.1 million, compared to a loss from continuing operations of $4.0 million for the same period in 2025. The $1.1 million increase in the loss from continuing operations was due to higher stock-based compensation and severance costs from our restructuring strategy.

Current report

The income tax expense was $0.2 million for the three-month period ended March 31, 2026, resulting in an effective tax rate of (4.9%). The income tax expense was $0.1 million for the three-month period ended March 31, 2025, resulting in an effective tax rate of (2.3%). The tax rates are consistent for the three-month period ended March 31, 2026, as compared to the same period in 2025, primarily due to a full valuation allowance being recorded against domestic deferred tax assets on March 31, 2026, and 2025.

Current report

Cash used in operating activities was $4.9 million and $0.1 million for the three-month periods ended March 31, 2026 and 2025, respectively. The increase in cash used in operating expenses was mainly due to inventory purchases with increased manufacturing production and building up safety stock and higher accounts receivable due to higher revenues. This was offset by higher stock-based compensation expense primarily related to the acceleration of stock-based compensation associated with the departure of our former Chief Executive Officer and an income tax refund received in the U.S.

Current report

Cash used in investing activities was $1.2 million for the three-month period ended March 31, 2026, as compared to cash provided by investing activities of $1.7 million for the same period in 2025. The change was primarily due to increase in capital expenditures as we are expanding capacity with manufacturing operations at our Bedford facility

Current report

Cash used in financing activities was $10.3 million and $5.4 million for the three-month periods ended March 31, 2026 and 2025, respectively. The increase in cash used in financing activities was primarily attributable to $8.7 million funding share repurchases during the three-month period ended March 31, 2026 versus $5.0 million in share repurchases in the prior year.
Removed paragraphs (23)

Previous report

We are a global joint preservation company that creates and delivers meaningful advancements in early intervention orthopedic care. Based on our collaborations with clinicians to understand what they need most to treat their patients, we develop minimally invasive products that restore active living for people around the world. We are committed to leading in high opportunity spaces within orthopedics, including osteoarthritis, or OA, pain management and regenerative solutions.

Previous report

In early 2020, we expanded our overall technology platform, product portfolio, and significantly expanded our commercial infrastructure, especially in the United States, through our strategic acquisitions of Parcus Medical, LLC, or Parcus Medical, a sports medicine and instrumentation solutions provider, and Arthrosurface Incorporated, or Arthrosurface, a company specializing in bone preserving partial and total joint replacement solutions. These acquisitions augmented our HA-based OA Pain Management and Regenerative Solutions products with a broad suite of products and capabilities focused on early intervention joint preservation, primarily in upper and lower extremities such as shoulder, foot/ankle, knee and hand/wrist.

Previous report

In October 2024, we announced a strategic shift to focus on our OA Pain Management and our Regenerative Solutions businesses. This strategic decision involved the sale of Arthrosurface in October 2024 and the sale of Parcus Medical in March 2025.

Previous report

In the United States, Monovisc and Orthovisc are marketed exclusively by 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 has subsequently extended this agreement, most recently in August 2022 through December 2028. Internationally, we market Monovisc and Orthovisc directly through a worldwide network of commercial distributors.

Previous report

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 are using a modular Premarket Approval, or PMA, filing process for our regulatory submission to the FDA for approval of Hyalofast in the U.S. We filed the first two modules with the FDA. 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, including statistically significant outcomes on key secondary endpoints such as Knee Injury and Osteoarthritis Outcomes Score, or KOOS, Sports and Recreation Function and Quality of Life and other measures including Total KOOS. 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.

Previous report

Three and Nine Months Ended September 30, 2025 Compared to Three and Nine Months Ended September 30, 2024

Previous report

During the year ended December 31, 2024, we changed our classification of revenue. We previously disclosed revenue in three categories: OA Pain Management, Joint Preservation and Restoration and Non-Orthopedic. As a result of a change in strategic focus announced by us in 2024, revenue classification was delineated to provide a clear view to our value drivers. Revenue has been split between the Commercial Channel and the Original Equipment Manufacturer, or OEM, Channel. In the Commercial Channel, we have full responsibility for sales, marketing, and pricing of products through our commercial leaders, direct sales representatives, and independent distributors. Revenue from our Regenerative Solutions and international OA Pain Management businesses is included in the Commercial Channel. In the OEM Channel, we are responsible for development and manufacturing of products sold to our OEM partners governed by long-term agreements, but we do not control sales, marketing, or pricing with end users. Revenue from our U.S. OA Pain Management business and the Non-Orthopedic business is now included in the OEM Channel. All other revenue is reported in the Commercial Channel.

Previous report

Revenue for the three- and nine- month periods ended September 30, 2025 were $27.8 million and $82.2 million, respectively. Revenue decreased $1.7 million and $7.1 million, or 6% and 8%, for the three- and nine- month periods ended September 30, 2025 compared to the same period in 2024, respectively. The decrease in revenue was driven by lower pricing with our OEM Channel partners, primarily J&J MedTech.

Previous report

Revenue from our OEM Channel product family decreased by 20% and 19% for the three- and nine-month periods ended September 30, 2025, respectively, as compared to the same period in 2024. For the three-month period ended September 30, 2025, the $3.9 million decrease was primarily driven by a $3.2 million decrease in J&J MedTech revenue which was all attributable to lower pricing. There was also a $0.7 million decrease in non-orthopedic product revenue due to lower volume of veterinary product sales. For the nine-month period ended September 30, 2025, the $11.0 million decrease in our OEM Channel revenue was primarily due to a $10.4 million reduction in J&J MedTech revenue, attributable primarily to lower pricing which contributed $8.3 million of the decrease, as well as lower sales volumes accounting for $2.1 million of the decrease. There was a $0.6 million decrease in non-orthopedic revenue for the nine-month period ended September 30, 2025 with prior year due to lower veterinary product sales offset somewhat by higher ophthalmic sales.

Previous report

Revenue from our Commercial Channel product family increased by 22% and 13% for the three- and nine-month periods ended September 30, 2025, respectively, as compared to the same period in 2024. For the three-month period ended September 30, 2025, international OA pain management product sales increased $1.5 million, primarily related to higher Cingal and Orthovisc sales and regenerative revenue was up $0.7 million due primarily to an increase of Integrity and Hyalofast sales. For the nine-month period ended September 30, 2025, regenerative revenue was up $2.4 million due primarily due to an increase in Integrity and Hyalofast revenues and international OA pain management sales were up $1.4 million due to higher Cingal and Orthovisc sales offset somewhat by lower Monovisc sales.

Previous report

Gross profit for the three- and nine-month periods ended September 30, 2025 was $15.6 million and $44.6 million, respectively. Gross profit for the three- and nine-month periods ended September 30, 2024 was $19.4 million and $58.9 million, respectively. The decrease in gross profit for the three- and nine-month periods ended September 30, 2025 was primarily related to higher inventory reserves, higher production costs and a larger percentage of international sales which have a lower average selling price.

Previous report

Gross margin for the three- and nine-month periods ended September 30, 2025 was 56% and 54%, respectively. Gross margin was 66% for each of the three- and nine-month periods ended September 30, 2024. The decrease in gross margin was due to higher inventory reserves, higher manufacturing costs and a larger percentage of international sales which have a lower average selling price.

Previous report

Research and development external costs for the three- and nine-month periods ended September 30, 2025 were $3.3 million and $8.4 million, respectively. Research and development external costs for the three- and nine-month periods ended September 30, 2024 were $2.3 million and $6.6 million, respectively. The increase in research and development external costs was primarily due to increased spending on Cingal regulatory submission activities and Integrity clinical studies.

Previous report

Research and development internal costs for the three- and nine-month periods ended September 30, 2025 were $3.7 million and $11.0 million, respectively. Research and development internal costs for the three- and nine-month periods ended September 30, 2024 were $3.7 million and $12.4 million, respectively. The decrease in internal research and development costs was primarily due to a reduction in headcount and a gain on the sale of an intangible asset during the three-month period ended September 30, 2025.

Previous report

Selling, general and administrative expenses for the three- and nine-month periods ended September 30, 2025 were $11.9 million and $37.0 million, respectively. Selling, general and administrative expenses for the three- and nine-month periods ended September 30, 2024 were $13.5 million and $44.2 million, respectively. The decrease for the three-month period ended September 30, 2025 was due to a $0.7 million decrease in stock-based compensation with the reminder of the decrease attributed to lower headcount. The decrease for the nine-month period ended September 30, 2025 was primarily due to $2.2 million in non-recurring shareholder activism costs, a $1.5 million decrease in stock-based compensation with the remainder of the decrease attributed to lower headcount and professional fees.

Previous report

For the three- and nine-month periods ended September 30, 2025, the loss from continuing operations was $3.2 million and $11.8 million, respectively. For the three- and nine-month periods ended September 30, 2024, the loss from continuing operations was $1.8 million and $6.3 million, respectively. The increase in the loss from continuing operations was primarily due to lower revenue and lower gross margin due to higher manufacturing costs and increased inventory reserves.

Previous report

The income tax expense was $0.9 million and $1.7 million for the three- and nine-month periods ended September 30, 2025, resulting in effective tax rates of (42.0)% and (17.0)%, respectively. The income tax expense was $2.2 million and $3.5 million for the three- and nine-month periods ended September 30, 2024, resulting in an effective tax rate of 667.7% and (126.3)%, respectively.

Previous report

The net change in the effective tax rate for the three- and nine-month periods ended September 30, 2025, compared to the same periods in 2024, was primarily driven by the impact of a higher year-to-date pre-tax loss in the current year and higher U.S. current tax expense in the prior year. The higher tax expense in the prior year was due to higher current income tax expense in the U.S.

Previous report

Adjusted EBITDA in the nine-month period ended September 30, 2025, decreased $11.1 million as compared with the same period in 2024. The decrease in Adjusted EBITDA for the period was primarily driven by lower revenue due primarily to a decrease in J&J Medtech sales and lower gross profit from higher manufacturing costs, higher inventory reserves and higher proportion of international sales that have a lower average selling price.

Previous report

Adjusted net income and adjusted diluted earnings per share in the nine-month period ended September 30, 2025 decreased $5.8 million and $0.40, respectively, as compared with the same period in 2024. The decrease for the period was primarily due to lower revenues and lower gross profit due primarily to higher inventory reserves.

Previous report

Cash provided by operating activities was $6.6 million for the nine-month period ended September 30, 2025, as compared to cash provided by operating activities of $3.8 million for the same period in 2024. The increase in cash provided by operating activities for the nine-months ended September 30, 2025, compared to the same period in prior year, was primarily due to a lower net loss and an improvement in the change in working capital during the nine-month period ended September 30, 2025, primarily from a reduction in inventory and an increase in accounts payable.

Previous report

Cash used in investing activities was $0.6 million for the nine-month period ended September 30, 2025, as compared to cash used in investing activities of $7.0 million for the same period in 2024. The change was primarily due to $4.5 million received from the sale of Parcus Medical. Capital expenditures were $6.2 million in the nine-month period ended September 30, 2025 compared to $6.4 million for the same period in 2024. The decrease in capital expenditures was due to timing of purchases related to our continued manufacturing capacity expansion at our facility in Bedford, Massachusetts.

Previous report

Cash used in financing activities was $5.3 million for the nine-month period ended September 30, 2025, as compared to cash used in financing activities of $7.4 million for the same period in 2024. In both periods, the cash used in financing activities was primarily attributable to utilization of cash for share repurchases and employee tax withholding in exchange for shares surrendered by equity award holders.
Reworded paragraphs (20)

Previous wording

You should read the following discussion in conjunction with our financial statements and related notes appearing elsewhere in this report and our audited consolidated financial statements and related notes contained in our Annual Report on Form 10-K for the year ended December 31, 2024, or our 2024 Form 10-K. In addition to historical information, this report contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 concerning our business, consolidated financial condition, and results of operations. The Securities and Exchange Commission, or the SEC, encourages companies to disclose forward-looking statements so that investors can better understand a company’s future prospects and make informed investment decisions. Forward-looking statements are subject to risks and uncertainties, many of which are outside our control, which could cause actual results to differ materially from these statements. Therefore, you should not rely on any of these forward-looking statements. Forward-looking statements can be identified by such words as "will," "likely," "may," "believe," "expect," "anticipate," "intend," "seek," "designed," "develop," "would," "future," "can," "could," and other expressions that are predictions of or indicate future events and trends and that do not relate to historical matters. All statements other than statements of historical facts included in this report regarding our strategies, prospects, financial condition, operations, costs, plans, and objectives are forward-looking statements. Examples of forward-looking statements include, among others, statements regarding expected future operating results, expectations regarding the timing and receipt of regulatory results, anticipated levels of capital expenditures, and expectations of the effect on our financial condition of claims, litigation, and governmental and regulatory proceedings.

Current wording

You should read the following discussion in conjunction with our financial statements and related notes appearing elsewhere in this report and our audited consolidated financial statements and related notes contained in our Annual Report on Form 10-K for the year ended December 31, 2025, or our 2025 Form 10-K. In addition to historical information, this report contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act, concerning our business, consolidated financial condition, and results of operations. The Securities and Exchange Commission, or the SEC, encourages companies to disclose forward-looking statements so that investors can better understand a company’s future prospects and make informed investment decisions. Forward-looking statements are subject to risks and uncertainties, many of which are outside our control, which could cause actual results to differ materially from these statements. Therefore, you should not rely on any of these forward-looking statements. Forward-looking statements can be identified by such words as "will," "likely," "may," "believe," "expect," "anticipate," "intend," "seek," "designed," "develop," "would," "future," "can," "could," and other expressions that are predictions of or indicate future events and trends and that do not relate to historical matters. All statements other than statements of historical facts included in this report regarding our strategies, prospects, financial condition, operations, costs, plans, and objectives are forward-looking statements. Examples of forward-looking statements include, among others, statements regarding expected future operating results, expectations regarding the timing and receipt of regulatory results, anticipated levels of capital expenditures, and expectations of the effect on our financial condition of claims, litigation, and governmental and regulatory proceedings.

Previous wording

We have over thirty years of global expertise developing, manufacturing and commercializing products based on our hyaluronic acid, or HA, technology platform. HA is a naturally occurring polymer found throughout the body that is vital for proper joint health and tissue function. Our proprietary technologies for modifying the HA molecule allow product properties to be tailored specifically to multiple uses, including enabling longer residence time to support OA pain management and creating a solid form of HA called Hyaff, which is a platform utilized in our Regenerative Solutions portfolio.

Current wording

We have over thirty years of global expertise developing, manufacturing and commercializing products based on our technology platform, HA. HA is a naturally occurring polymer found throughout the body that is vital for proper joint health and tissue function. Our proprietary technologies for modifying the HA molecule allow product properties to be tailored specifically to multiple uses, including enabling longer residence time to support OA pain management and creating a solid form of HA called Hyaff, which is a platform utilized in our Regenerative Solutions portfolio.

Previous wording

As we look towards the future, our business is positioned to capture value within our target markets of OA Pain Management and Regenerative Solutions. We believe our future success will be driven by our:

Current wording

As we look forward to the future, our business is positioned to capture value within our target markets of OA Pain Management and Regenerative Solutions. We believe our future success will be driven by our:

Previous wording

Our OA Pain Management product family consists of Monovisc and Orthovisc, our injectable, HA-based OA pain management offerings that are indicated to provide pain relief from osteoarthritis conditions; and Cingal, our novel, single-injection OA Pain Management product consisting of our proprietary cross-linked HA combined with a fast-acting steroid.

Current wording

Our OA Pain Management product family consists of Monovisc and Orthovisc, our injectable, HA-based OA pain management offerings that are indicated to provide pain relief from OA conditions; and Cingal, our novel, single-injection OA Pain Management product consisting of our proprietary cross-linked HA material combined with a fast-acting steroid.

Previous wording

Cingal is our next generation fast-acting, long-lasting, non-opioid, clinically proven osteoarthritis pain product which is designed to provide both short- and long-term pain relief through at least six months. It is currently sold outside the United States in over 50 countries. In 2022, we completed a third Phase III clinical trial for Cingal, which achieved its primary endpoint. Cingal is not currently approved for commercial use in the United States. We have been actively engaging with the U.S. Food and Drug Administration, or the FDA, on next steps for U.S. regulatory approval.

Current wording

Cingal is our next generation fast-acting, long-lasting, non-opioid, clinically proven OA pain product that is designed to provide both short- and long-term pain relief through at least six months. It is currently sold outside the United States in over 35 countries. In 2022, we completed a third Phase III clinical trial for Cingal, which achieved its primary endpoint. We have been actively engaging with the U.S. Food and Drug Administration, or the FDA, on next steps for U.S. regulatory approval. We have made significant progress in addressing the FDA's requirements for Cingal's approval. In April 2023, we held a Type-C meeting with the FDA, which led to an advice letter received from the FDA in April 2024. The letter included positive feedback and new challenges that we are actively addressing. 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 New Drug Application, or 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. addressable market.

Previous wording

Our Regenerative Solutions product family consists of: (a) our portfolio of orthopedic regenerative solutions products utilizing HA, including Integrity, our hyaluronic acid-based scaffold for rotator cuff repair and other tendon procedures, Tactoset, an HA-enhanced, flowable, injectable and settable bone void filler used to facilitate bone regeneration and augment hardware in poor quality bone, and Hyalofast, a hyaluronic acid scaffold for cartilage repair, sold outside of the United States in over 30 countries. Hyalofast is not currently approved for commercial use in the United States.

Current wording

Our Regenerative Solutions product family consists of: (a) our portfolio of orthopedic regenerative solutions products utilizing HA, including Integrity, our HA-based scaffold for rotator cuff repair and other tendon procedures, Tactoset, an HA-enhanced, flowable, injectable and settable bone void filler used to facilitate bone regeneration and augment hardware in poor quality bone, and Hyalofast, a hyaluronic acid scaffold for cartilage repair, sold outside of the United States in over 30 countries. In the United States, Hyalofast is a pipeline product under a pivotal Investigational Device Exemption or IDE clinical trial and is not available for commercial sale. We submitted a premarket approval or PMA on October 31, 2025 with the FDA, and we are targeting a U.S. launch by 2027, pending approval from the FDA.

Previous wording

The following table presents revenue by product family for the three and nine-month periods ended September 30, 2025 and 2024:

Current wording

The following table presents revenue by product family for the three-month periods ended March 31, 2026, and 2025 as follows:

Previous wording

Research and development expenses for the three- and nine-month periods ended September 30, 2025 were as follows:

Current wording

Research and development expenses for the three-month period ended March 31, 2026, are as follows:

Previous wording

We present certain information with respect to adjusted Earnings Before Interest, Tax, Depreciation and Amortization, or EBITDA, adjusted net income, adjusted diluted earnings per share or adjusted EPS, which are financial measures not based on any standardized methodology prescribed by accounting principles generally accepted in the United States, or GAAP, and is not necessarily comparable to similarly titled measures presented by other companies.

Current wording

We present certain information with respect to adjusted Earnings Before Interest, Tax, Depreciation and Amortization, or EBITDA, adjusted net income(loss), and adjusted diluted earnings per share or adjusted EPS, which are financial measures not based on any standardized methodology prescribed by accounting principles generally accepted in the United States, or GAAP, and are not necessarily comparable to similarly titled measures presented by other companies.

Previous wording

We have presented adjusted EBITDA, adjusted net income, adjusted EPS, because they are key measures used by our management and board of directors to understand and evaluate our operating performance and to develop operational goals for managing our business. We believe these financial measures help identify underlying trends in our business that could otherwise be masked by the effect of the expenses that we exclude. In particular, we believe that the exclusion of these items in calculating these measures can provide a useful tool for period-to-period comparisons of our core operating performance. Accordingly, we believe that these measures provide useful information to investors and others in understanding and evaluating our operating results, enhancing the overall understanding of our past performance and future prospects and allowing for greater transparency with respect to key financial metrics used by our management in their financial and operational decision-making.

Current wording

We have presented adjusted EBITDA, adjusted net income, and adjusted EPS, because they are key measures used by our management and board of directors to understand and evaluate our operating performance and to develop operational goals for managing our business. We believe these financial measures help identify underlying trends in our business that could otherwise be masked by the effect of the expenses that we exclude. In particular, we believe that the exclusion of these items in calculating these measures can provide a useful tool for period-to-period comparisons of our core operating performance. Accordingly, we believe that these measures provide useful information to investors and others in understanding and evaluating our operating results, enhancing the overall understanding of our past performance and future prospects and allowing for greater transparency with respect to key financial metrics used by our management in their financial and operational decision-making.

Previous wording

We present information below with respect to adjusted EBITDA, which we define as our net income (loss) excluding interest and other expense, net, income tax benefit, depreciation and amortization, stock-based compensation, and acquisition-related expenses.

Current wording

We present information below with respect to adjusted EBITDA, which we define as our net loss excluding interest and other (income), net, provision for income tax, depreciation and amortization, share-based compensation, severance costs and non-recurring professional fees.

Previous wording

The following is a reconciliation of adjusted EBITDA, a non-GAAP metric, to net loss, the most directly comparable GAAP financial measure, for the three and nine-month periods ended September 30, 2025 and 2024, respectively:

Current wording

The following is a reconciliation of adjusted EBITDA, a non-GAAP metric, to net loss, the most directly comparable GAAP financial measure, for the three-month periods ended March 31, 2026 and 2025, respectively:

Previous wording

Adjusted EBITDA in the three-month period ended September 30, 2025 decreased by $3.7 million as compared with the same period in 2024. The decrease in Adjusted EBITDA for the period was primarily driven by lower revenue due primarily to a decrease in J&J Medtech sales and lower gross profit from higher manufacturing costs and higher proportion of international sales that have a lower average selling price.

Current wording

Adjusted EBITDA in the three-month period ended March 31, 2026, increased $4.2 million as compared with the same period in 2025. The increase in adjusted EBITDA for the period was primarily due to higher revenue and gross profit.

Previous wording

We present information below with respect to adjusted net (loss) income and adjusted EPS. We define adjusted net (loss) income as our net (loss) income excluding amortization and depreciation of acquired assets, share-based compensation, and other non-recurring items, such as product rationalization charges, severance costs and costs of shareholder activism. We define adjusted EPS as GAAP diluted earnings per share excluding the above adjustments to net (loss) income used in calculating adjusted net (loss) income, each on a per share and tax effected basis.

Current wording

We present information below with respect to adjusted net income(loss) and adjusted EPS. We define adjusted net income (loss) as our net loss excluding share-based compensation, severance costs, and non-recurring professional fees. We define adjusted EPS as GAAP diluted EPS excluding the above adjustments to net income (loss) used in calculating adjusted net income (loss), each on a per share and tax effected basis.

Previous wording

The following is a reconciliation of adjusted net loss, a non-GAAP metric, to net income (loss), the most directly comparable GAAP financial measure, for the three and nine-month periods ended September 30, 2025 and 2024, respectively:

Current wording

The following is a reconciliation of adjusted net income (loss), a non-GAAP metric, to net loss, the most directly comparable GAAP financial measure, for the three-month periods ended March 31, 2026 and 2025, respectively:

Previous wording

The following is a reconciliation of adjusted diluted EPS, a non-GAAP metric, to diluted EPS, the most directly comparable GAAP financial measure, for the three and nine-month periods ended September 30, 2025 and 2024, respectively:

Current wording

The following is a reconciliation of adjusted diluted EPS, a non-GAAP metric, to diluted EPS, the most directly comparable GAAP financial measure, for the three-month periods ended March 31, 2026, and 2025, respectively:

Previous wording

Adjusted net income and adjusted diluted earnings per share in the three-month period ended September 30, 2025 decreased $0.4 million and $0.03, respectively, as compared with the same period in 2024. The decrease for the period was primarily due to lower revenues and lower gross profit.

Current wording

Adjusted net income and adjusted diluted earnings per share in the three-month period ended March 31, 2026, increased by $4.7 million and $0.33, respectively, as compared with the same period in 2025. The increase for the period was primarily due to higher revenue and gross profit.

Previous wording

We require cash to fund our operating activities and to make capital expenditures and other investments in the business. We expect that our requirements for cash to fund these uses will increase as our operations expand. We continue to generate cash from operating activities and believe that our operating cash flows, cash currently on our balance sheet and availability under our credit facility will be sufficient to allow us to continue to invest in our existing business, to manage our capital structure on a short and long-term basis, and to meet our anticipated operating cash needs. Cash and cash equivalents aggregated $58.0 million and $55.6 million, and working capital totaled $82.5 million and $90.3 million, at September 30, 2025 and December 31, 2024, respectively.

Current wording

We require cash to fund our operating activities and to make capital expenditures and other investments in the business. We expect that our requirements for cash to fund these uses will increase as our operations expand. We continue to generate cash from operating activities and believe that our operating cash flows, cash currently on our condensed consolidated balance sheet and availability under our credit facility will be sufficient to allow us to continue to invest in our existing business, to manage our capital structure on a short and long-term basis, and to meet our anticipated operating cash needs. Cash and cash equivalents aggregated $41.0 million and $57.5 million, and working capital totaled $72.6 million and $80.2 million, at March 31, 2026, and December 31, 2025, respectively.

Previous wording

The following changes contributed to the net change in cash and cash equivalents in the nine-month period ended September 30, 2025 as compared to the same period in 2024.

Current wording

The following changes contributed to the net change in cash and cash equivalents in the three-month period ended March 31, 2026 as compared to the same period in 2025.

Previous wording

Our contractual obligations and other commercial commitments are summarized in the section captioned “Part II, Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations—Liquidity and Capital Resources—Contractual Obligations and Other Commercial Commitments” in our 2024 Form 10-K for the year ended December 31, 2024. There were no material changes to our contractual obligations reported in our 2024 Form 10-K during the nine months ended September 30, 2025. For additional discussion, see Note 11 to the condensed consolidated financial statements included in this report.

Current wording

Our contractual obligations and other commercial commitments are summarized in the section captioned “Part II, Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations—Liquidity and Capital Resources—Contractual Obligations and Other Commercial Commitments” in our 2025 Form 10-K for the year ended December 31, 2025. There were no material changes to our contractual obligations reported in our 2025 Form 10-K during the three months ended March 31, 2026. For additional discussion, see Note 9 to the condensed consolidated financial statements included in this report.