Anika Therapeutics, Inc.

Previous wording

We are a global leader in the design, development, manufacturing and commercialization of hyaluronic acid, or HA, innovations. In partnership with our 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 wording

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

Previous wording

We have over 30 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.

Current wording

We have over 30 years of global expertise developing, manufacturing and commercializing products based on our 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.

Previous 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 3 clinical trial for Cingal, which achieved its primary endpoint. We have been actively engaging with 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. We are continuing to advance NDA preparation activities and are working towards a submission to the FDA. Chemistry, Manufacturing and Controls (“CMC”) activities required for approval of HA as a drug remain a key milestone in the regulatory pathway and are expected to be a primary focus as we advance toward filing. While we remain confident in the clinical profile and commercial opportunity for Cingal, the timing of any potential NDA submission or regulatory approval remains subject to the completion of these development and regulatory requirements. We are committed to bringing this revolutionary pain management therapy to the approximate $1 billion U.S. addressable market.

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 3 clinical trial for Cingal, which achieved its primary endpoint. We have been actively engaging with the FDA, on next steps for U.S. regulatory approval. We continue to work towards addressing the FDA's requirements for Cingal's approval and are continuing to advance New Drug Application or NDA, preparation activities and are working towards a submission to the FDA. In September 2026, we completed enrollment in the bioequivalence study, which was one of the key FDA requirements. Chemistry, Manufacturing and Controls, or CMC, activities required for approval of HA as a drug also remain a key milestone in the regulatory pathway and are expected to be a primary focus as we advance toward filing. We are targeting to make the NDA submission by December 31, 2027. Regulatory approval remains subject to the completion of these development and regulatory requirements. We are committed to bringing this revolutionary pain management therapy to the approximate $1 billion U.S. addressable market.

Previous wording

Hyalofast is not currently approved for commercial use in the United States and is not available for commercial sale. Anika submitted a Premarket Approval (“PMA”) application to the FDA on October 31, 2025, following completion of its pivotal Investigational Device Exemption (“IDE”) clinical trial. The Company remains actively engaged with the FDA as it works through the ongoing PMA review process and responses to the deficiency letter that the Company received in January 2026.

Current wording

Hyalofast is not currently approved for commercial use in the United States and is not available for commercial sale. We submitted a Premarket Approval, or PMA, application to the FDA on October 31, 2025, following completion of a pivotal Investigational Device Exemption, or IDE, clinical trial. In October 2026, we received formal notification from the FDA that our current Hyalofast PMA application is not approvable, primarily based on the clinical data included in the submission. We continue to believe strongly in Hyalofast’s potential in the U.S. market, and we will continue discussions with the FDA regarding the evidence that may be required to support future approval.

Previous wording

Three and Six Months Ended June 30, 2026, Compared to Three and Six Months Ended June 30, 2025

Current wording

Three and Nine Months Ended September 30, 2026 Compared to Three and Nine Months Ended September 30, 2025

Previous wording

The following table presents revenue by product family for the three and six-month periods ended June 30, 2026, and 2025:

Current wording

The following table presents revenue by product family for the three and nine-month periods ended September 30, 2026, and 2025:

Previous wording

Revenue for the three- and six- month periods ended June 30, 2026, was $32.6 million and $62.2 million, respectively. Revenue increased $4.4** *million and $7.8 million, or 16% and 14%, for the three- and six- month periods ended June 30, 2026, compared to the same periods in 2025, respectively. The increase in revenue was driven by higher sales activity with our Original Equipment Manufacturer, or OEM Channel partners, primarily J&J MedTech, as well as higher Commercial Channel revenue due to international OA Pain Management revenues and Integrity revenues. *

Current wording

Revenue for the three- and nine-month periods ended September 30, 2026 were $30.6 million and $92.8 million, respectively, representing increases of $2.8 million and $10.6 million, or 10% and 13%, respectively, compared to the same period in 2025. The increase was primarily driven by higher Commercial Channel revenue due to international OA pain management revenues and Integrity product sales as well as higher OEM revenue through our OEM Channel partners, primarily DePuy Synthes.

Previous wording

Revenue from our OEM Channel product family increased by 14% for each of the three- and six-month periods ended June 30, 2026, respectively, compared to the same periods in 2025. For the three-month period ended June 30, 2026, the $2.4 million increase was primarily due to a $3.2 million increase in J&J MedTech revenue due to $6.1 million increase in sales volume, offset by a $2.9 million decrease due to lower pricing. This was offset by a $0.9 million decline in non-orthopedic revenue, largely attributable to shipment timing of veterinary products. For the six-month period ended June 30, 2026, OEM revenue increased as result of a $4.2 million increase in J&J MedTech revenue, due to $8.9 million increase in sales volume, offset by a $4.7 million decrease due to lower pricing. Non-orthopedic product revenue also increased by $0.3 million, due to timing on surgical product sales.

Current wording

Revenue from our OEM Channel product family increased 5% and 11% for the three- and nine-month periods ended September 30, 2026, respectively, compared to the same periods in 2025. For the three-month period ended September 30, 2026, the $0.8 million increase was due to a $0.5 million increase in non-orthopedic revenues primarily from the relaunch of Hyalomatrix and higher veterinary revenue; and a $0.3 million increase in DePuy Synthes revenues due to a $1.3 million increase in volume, primarily on Monovisc sales, offset by a $1.0 million decrease due to lower pricing. For the nine-month period September 30, 2026, the $5.2 million increase in OEM Channel revenue was primarily attributable to a $4.4 million increase in DePuy Synthes revenue, due to a $10.1 million increase in sales volume, offset by a $5.7 million decrease due to lower pricing and a $0.8 million increase in non-orthopedic revenues from higher Hyvisc, Hyalomatrix and Hyalobarrier product sales.

Previous wording

Revenue from our Commercial Channel product family increased 17% and 14% for the three- and six-month periods ended, June 30, 2026, respectively. For the three-month period ended June 30, 2026, regenerative product revenue increased by $0.4 million, primarily due to higher sales of Integrity and Hyalofast. International OA pain management product revenue increased by $1.6 million, due to higher sales of Cingal and Monovisc. For the six-month period ended June 30, 2026, regenerative revenue increased by $1.0 million, primarily due to higher sales in Integrity and Hyalofast sales. International OA pain management product revenue increased $2.3 million, driven by higher sales of Monovisc and Cingal.

Current wording

Revenue from our Commercial Channel product family increased 17% and 15% for the three- and nine-month periods ended September 30, 2026, respectively, compared to the same periods in 2025. For the three-month period ended September 30, 2026, Commercial Channel revenue increased by $2.0 million, driven by a $1.6 million increase in international OA Pain Management revenues, primarily from higher sales of Monovisc and Cingal and a $0.4 million increase in regenerative revenue, primarily from sales of Integrity products. For the nine-month period ended September 30, 2026, Commercial Channel revenue increased by $5.4 million, driven by a $3.9 million increase in international OA Pain Management revenues, primarily from higher sales volumeof Monovisc and Cingal and a $1.4 million increase in regenerative revenue, primarily from sales of Integrity and Hyalofast products.

Previous wording

Gross profit for the three- and six-months periods ended June 30, 2026, increased $6.9 million and $11.2 million to $21.2 million and $40.2 million, respectively. Gross profit for the three- and six-month periods ended June 30, 2025, was $14.4 million and $29.0 million, respectively. The increase in gross profit for the three- and six-month periods ended June 30, 2026, was primarily related to higher sales volume.

Current wording

Gross profit for the three- and nine-month periods ended September 30, 2026, was $18.8 million and $59.1 million, respectively. Gross profit for the three- and nine-month periods ended September 30, 2025, was $15.6 million and $44.6 million, respectively. The increase in gross profit for the three- and nine-month periods ended September 30, 2026, was primarily related to higher sales volumes and manufacturing productivity.

Previous wording

Gross margin for each of the three- and six-month periods ended June 30, 2026, was 65%. Gross margin for the three- and six-month period ended June 30, 2025, was 51% and 53%, respectively. The increase in gross margin was due to higher sales volume, increased manufacturing production and improved sales mix due to higher J&J MedTech revenues.

Current wording

Gross margin for the three- and nine-month periods ended September 30, 2026, was 62% and 64%, respectively. Gross margin was 56% and 54% for the three- and nine-month periods ended September 30, 2025, respectively. The increase in gross margin was due to higher sales volume, increased manufacturing production, lower inventory reserves and improved product sales mix, primarily from higher DePuy Synthes revenues.

Previous wording

Research and development expenses for the three- and six-month periods ended June 30, 2026, were as follows:

Current wording

Research and development expenses for the three- and nine-month periods ended September 30, 2026, and 2025 were as follows:

Previous wording

Research and development external costs for the three- and six-month periods ended June 30, 2026, were $3.0 million and $5.5 million, respectively. Research and development external costs for the three- and six-month periods ended June 30, 2025, were $2.8 million and $5.1 million, respectively. The increase in research and development external costs was primarily due to increased spending on Cingal clinical study and Integrity development costs offset somewhat by Hyalofast clinical trial costs.

Current wording

Research and development external costs were $3.0 million and $8.5 million for the three- and nine-month periods ended September 30, 2026, respectively, compared to $3.3 million and $8.4 million for the corresponding periods in 2025. The decrease in external research and development costs for the three-month period ended September 30, 2026 was primarily driven by lower spending on the Hyalofast and Cingal clinical studies. For the nine-month period ended September 30, 2026, external research and development costs increased slightly by $0.1 million, primarily from higher clinical spending on Cingal and an increase in regulatory and new product development costs, offset by a decrease in Hyalofast clinical expenditures related to PMA submission to the FDA in late 2025.

Previous wording

Selling, general and administrative expenses for the three- and six-month periods ended June 30, 2026, were $10.9 million and $28.7 million, respectively. Selling, general and administrative expenses for the three- and six-month periods ended June 30, 2025, were $12.2 million and $25.1 million, respectively. The decrease for the three-month period ended June 30, 2026, was due primarily to reduced headcount with severance actions announced in the first quarter of 2026 and lower legal fees. The increase for the six-month period ended June 30, 2026, was primarily due to $2.4 million in severance costs recorded in 2026 and $2.4 million increase in stock-based compensation, primarily related to a charge during the three-month period ended March 31, 2026, for the transition of the Company’s former Chief Executive Officer. This was offset by lower legal and professional fees.

Current wording

Selling, general and administrative expenses for the three- and nine-month periods ended September 30, 2026, were $11.7 million and $40.4 million, respectively. 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. The decrease for the three-month period ended September 30, 2026 was due primarily to a $0.7 million decrease in legal expenses and lower employee-related costs due to a reduction in headcount offset by a $1.4 million increase in stock-based compensation. The increase for the nine-month period ended September 30, 2026, was primarily due to $2.5 million in severance costs and a $3.9 million increase in stock-based compensation primarily related to a charge during the three-month period ended March 31, 2026, for the transition of our former Chief Executive Officer, which was partially offset by a $1.2 million decrease in legal expense and lower headcount costs.

Previous wording

The income tax expense was $0.1 million and $0.3 million for the three- and six-month periods ended June 30, 2026, resulting in effective tax rates of 2.1% and (21.2) %, respectively. The income tax expense was $0.7 million and $0.8 million for the three- and six-month periods ended June 30, 2025, resulting in an effective tax rate of (17.2) % and (9.8) %, respectively. The decrease in income tax expense was due to lower taxable income expected in the U.S. in 2026 due to the ability to deduct more research and development costs. The Company’s effective tax rate for the three-month and six-month periods ended June 30, 2026, was primarily driven by the full valuation on the Company's deferred tax assets in the US and the projected taxable income for the Company resulting in current tax expense in 2026.

Current wording

We had a small income tax benefit for the three-month period ended September 30, 2026, and $0.3 million in income tax expense for the nine-month period ended September 30, 2026, resulting in effective tax rates of 3.4% and (16.7)%, respectively. We had income tax expense of $0.9 million and $1.7 million for the three- and nine-month periods ended September 30, 2025, resulting in an effective tax rate of (42.0)% and (17.0)%, respectively. Our effective tax rate for the three-month and nine-month periods ended September 30, 2026, was primarily driven by the full valuation on our deferred tax assets in the United States and our projected taxable income resulting in current tax expense in 2026.

Previous wording

We present certain information with respect to adjusted Earnings Before Interest, Tax, Depreciation and Amortization, or EBITDA, adjusted net income, (loss) from continuing operations, 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.

Current wording

We present certain information with respect to adjusted Earnings Before Interest, Tax, Depreciation and Amortization, or EBITDA, adjusted net income from continuing operations, and adjusted diluted earnings per share or adjusted EPS from continuing operations, 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, (loss) from continuing operations, 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.

Current wording

We have presented adjusted EBITDA, adjusted net income from continuing operations, and adjusted EPS from continuing operations, 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) from continuing operations excluding interest and other (income) expense, net, income tax benefit (provision), depreciation and amortization, share-based compensation, and severance costs.

Current wording

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

Previous wording

Adjusted EBITDA is not prepared in accordance with GAAP, and should not be considered in isolation of, or as an alternative to, measures prepared in accordance with GAAP. There are a number of limitations related to the use of adjusted EBITDA rather than net income (loss) from continuing operations, which is the nearest GAAP equivalent. Some of these limitations are:

Current wording

Adjusted EBITDA is not prepared in accordance with GAAP, and should not be considered in isolation of, or as an alternative to, measures prepared in accordance with GAAP. There are a number of limitations related to the use of adjusted EBITDA rather than net loss from continuing operations, which is the nearest GAAP equivalent. Some of these limitations are:

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 six-month periods ended June 30, 2026, and 2025, respectively:

Current wording

The following is a reconciliation of adjusted EBITDA, a non-GAAP metric, to net loss from continuing operations, the most directly comparable GAAP financial measure, for the three and nine-month periods ended September 30, 2026, and 2025, respectively:

Previous wording

Adjusted EBITDA in the six-month period ended June 30, 2026, increased $11.6** **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.

Current wording

Adjusted EBITDA for the three-month period ended September 30, 2026 increased by $4.2 million compared to the same period in 2025. The increase was primarily driven by higher revenue as well as higher gross profit resulting from manufacturing efficiencies and favorable product mix.

Previous wording

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

Current wording

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

Previous wording

The following is a reconciliation of adjusted net income (loss) from continuing operations, a non-GAAP metric, to net income (loss) from continuing operations, the most directly comparable GAAP financial measure, for the three and six-month periods ended June 30, 2026, and 2025, respectively:

Current wording

The following is a reconciliation of adjusted net income (loss) from continuing operations, a non-GAAP metric, to net loss from continuing operations, the most directly comparable GAAP financial measure, for the three and nine-month periods ended September 30, 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 six-month periods ended June 30, 2026, and 2025, respectively:

Current wording

The following is a reconciliation of adjusted diluted EPS from continuing operations, a non-GAAP metric, to diluted EPS from continuing operations, the most directly comparable GAAP financial measure, for the three and nine-month periods ended September 30, 2026, and 2025, respectively:

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 $38.4** **million and $57.5 million, and working capital totaled $77.0 million and $80.2 million, at June 30, 2026, and December 31, 2025, respectively.

Current wording

We require cash to fund our operating activities and to make capital expenditures and other investments in our 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 $45.0 million and $57.5 million, and working capital totaled $76.3 million and $81.5 million, at September 30, 2026 and December 31, 2025, respectively.

Previous wording

The following changes contributed to the net change in cash and cash equivalents in the six-month period ended June 30, 2026, as compared to the same period in 2025.

Current wording

The following changes contributed to the net change in cash and cash equivalents in the nine-month period ended September 30, 2026, as compared to the same period in 2025.

Previous wording

Cash used in investing activities was $2.5 million for the six-month period ended June 30, 2026, as compared to cash provided in investing activities of $1.1 million for the same period in 2025. The change was primarily due to $4.5 million received from the sale of Parcus Medical in March 2025. Capital expenditures were $2.9 million in the six-month period ended June 30, 2026, compared to $4.3 million for the same period in 2025. The decrease in capital expenditures was due to timing of purchases related to our continued manufacturing capacity expansion at our facility in Bedford, Massachusetts.

Current wording

Cash used in investing activities was $4.3 million for the nine-month period ended September 30, 2026 compared to cash used in investing activities of $0.6 million for the same period in 2025. The change was primarily due to $4.5 million received from the sale of Parcus Medical in March 2025. Capital expenditure was $4.6 million in the nine-month period ended September 30, 2026, compared to $6.2 million for the same period in 2025. The decrease in capital expenditure was due to timing of purchases related to our continued manufacturing capacity expansion at our facility in Bedford, Massachusetts.