Anika Therapeutics, Inc.
For the period ended Jun 30, 2025. Filed Jul 30, 2025.
View on SEC.govAbout 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.
Jun 30, 2025 · Filed Jul 30, 2025
ANIK$14.55-24.7%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-03-31; filed 2025-05-09.
0001171843-25-003019
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-06-30; filed 2025-07-30.
0001171843-25-004826
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe 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 61 previous paragraphs and 69 current paragraphs.
39 unchanged; 14 reworded; 15 added; 8 removed; 0 previous and 1 current paragraphs rearranged.
Tables are not compared: 18 previous and 21 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 (15)
Current 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 scaffold for cartilage repair. This clinical trial had a two-year follow-up protocol. We are using a modular Premarket Approval (“PMA”) filing process for our regulatory submission to the FDA for approval of Hyalofast in the U.S. We have filed the first two modules with the FDA and were awaiting clinical data to submit the final module to 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 (“KOOS”) Sports and Recreation Function and Quality of Life and other measures including Total KOOS. The study was likely impacted by both a 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 plan to submit the final PMA module to the FDA in the second half of 2025.
Current report
Three and Six Months Ended June 30, 2025 Compared to Three and Six Months Ended June 30, 2024
Current 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 (“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.
Current report
Revenue from our OEM Channel product family decreased by 13% and 18% for the three- and six-month periods ended June 30, 2025, as compared to the same period in 2024. For the three-month period ended June 30, 2025, the $2.5 million decrease was primarily driven by a $3.0 million decrease in J&J MedTech revenue, attributable to lower sales volumes of $1.9 million and lower pricing which contributed $1.1 million of the decrease. This was offset somewhat by higher non-orthopedic product revenue of $0.5 million due to higher veterinary product sales. For the six-month period ended June 30, 2025, OEM Channel revenue decreased due to a $7.1 million reduction in J&J MedTech revenue, attributable to lower sales volumes of $2.9 million and lower pricing which contributed $4.2 million of the decrease. There was no change in non-orthopedic revenue for the six-month period ended June 30, 2025 with prior year.
Current report
Revenue from our Commercial Channel product family had no change for the three-month period ended June 30, 2025 and increased 8% for the six-month period ended June 30, 2025, as compared to the same period in 2024. For the three-month period ended June 30, 2025, regenerative revenue was up $1.0 million due primarily to higher Integrity and Hyalofast sales offset by a $1.0 million decrease in international OA pain management product sales, primarily related to timing of Monovisc shipments. For the six-month period ended June 30, 2025, regenerative revenue was up $1.7 million due primarily to higher Integrity and Hyalofast revenues.
Current report
Gross profit for the three-month period ended June 30, 2025 decreased $6.1 million and $10.4 million for the six-month period ended June 30, 2025 to $14.4 million and $29.0 million, respectively. Gross profit for the three- and six-month periods ended June 30, 2024 was $20.5 million and $39.5 million, respectively. The decrease in gross profit for the three- and six-month periods ended June 30, 2025 was primarily related to higher inventory reserves, higher production costs and lower revenue related to the timing of OA Pain Management revenues.
Current report
Gross margin for the three- and six-month periods ended June 30, 2025 was 51% and 53%, respectively. Gross margin for the three- and six-month period ended June 30, 2024 was 67% and 66%, respectively. 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.
Current report
Research and development expenses for the three- and six-month periods ended June 30, 2025 were as follows:
Current report
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. Research and development external costs for the three- and six-month periods ended June 30, 2024 were $5.1 million and $4.3 million, respectively. The increase in research and development external costs was primarily due to increased spending on Cingal and Integrity clinical studies.
Current report
Research and development internal costs for the three- and six-month periods ended June 30, 2025 were $3.5 million and $7.3 million, respectively. Research and development internal costs for the three- and six-month periods ended June 30, 2024 were $4.3 million and $8.8 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 June 30, 2025.
Current report
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. Selling, general and administrative expenses for the three- and six-month periods ended June 30, 2024 were $15.6 million and $30.7 million, respectively. The decrease was primarily due to $1.0 million and $2.4 million in non-recurring shareholder activism costs in the three- and six-month periods ended June 30, 2024, respectively with the remainder of the decrease attributed to lower headcount.
Current report
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 effective tax rates of (17.2)% and (9.8)%, respectively. The income tax expense was $1.3 million and $1.4 million for the three- and six-month periods ended June 30, 2024, resulting in an effective tax rate of (109.2)% and (43.8)%, respectively.
Current report
The net change in the effective tax rate for the three- and six-month periods ended June 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 greater projected U.S. taxable income, despite the continued presence of a full valuation allowance in 2025.
Current report
Adjusted EBITDA in the six-month period ended June 30, 2025, decreased $7.6 million as compared with the same period in 2024. The decrease in Adjusted EBITDA for the period was primarily driven by lower gross profit from lower revenue and higher manufacturing costs.
Current report
Cash used in operating activities was $0.3 million for the six-month period ended June 30, 2025, as compared to cash used in operating activities of $1.2 million for the same period in 2024. The decrease in cash used in operating activities for the six-months ended June 30, 2025, compared to the same period in prior year, was primarily due to an improvement in the change in working capital during the six-month period ended June 30, 2025, primarily from a reduction in inventory and accounts receivable.
Removed paragraphs (8)
Previous report
Three Months Ended March 31, 2025 Compared to Three Months Ended March 31, 2024
Previous report
Revenue from our OEM Channel product family decreased by 23% for the three-month period ended March 31, 2025, as compared to the same period in 2024, due primarily to lower pricing on sales to J&J MedTech, and lower revenue from J&J MedTech due to lower end user sales in 2025.
Previous report
Revenue from our Commercial Channel product family increased 18% for the three-month period ended March 31, 2025, as compared to the same period in 2024, primarily due to higher international sales on our OA Pain Management products and growing commercial adoption of our newest products, particularly Integrity, which offset lower sales of certain legacy products.
Previous report
Gross profit for the three-month period ended March 31, 2025 decreased $4.3 million to $14.7 million, representing a 56% gross margin for the period as compared to 65% in the prior year. The decrease in gross profit for the three-month period ended March 31, 2025, as compared to the same period in 2024, primarily resulted from lower revenue and higher manufacturing costs. Gross margin for the three-month period ended March 31, 2025 decreased compared to the same period of prior year due to larger percentage of international sales that generally have a lower average selling price, higher manufacturing costs and increase in inventory reserves and scrap.
Previous report
Research and development expenses for the three-month period ended March 31, 2025 were $6.1 million, a decrease of $0.3 million as compared to the same period in 2024. The decrease was primarily related to reduced headcount and lower product development and regulatory costs.
Previous report
Selling, general and administrative expenses for the three-month period ended March 31, 2025 were $12.9 million, a decrease of $2.2 million, as compared to the same period in 2024. This decrease for the three-month period ended March 31, 2025 was primarily due to reduced headcount, lower marketing expenses and other non-recurring corporate costs that occurred in 2024.
Previous report
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 income tax expense was immaterial for the three-month period ended March 31, 2024, resulting in an effective tax rate of (2.2%). The tax rates are consistent for the three-month period ended March 31, 2025, as compared to the same period in 2024, primarily due to a full valuation allowance being recorded against domestic deferred tax assets at March 31, 2024.
Previous report
Cash used in operating activities was $0.1 million for each of the three-month periods ended March 31, 2025 and 2024, respectively. We had a slightly higher net loss during the three-month period ended March 31, 2025 that caused an increase in cash used in operating activities in 2024 offset by lower stock-based compensation, depreciation and amortization and improved working capital.
Reworded paragraphs (14)
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.
Current 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.
Previous wording
The following table presents revenue by product family for the three-month period ended March 31, 2025 and 2024 as follows:
Current wording
The following table presents revenue by product family for the three and six-month periods ended June 30, 2025 and 2024:
Previous wording
Revenue for the three-month period ended March 31, 2025 was $26.2 million, a decrease of $2.9 million, or 10%, compared to the same period in 2024. The decrease in revenue was driven by lower sales activity with our OEM Channel partners, primarily J&J MedTech and the discontinuation of certain non-orthopedic products.
Current wording
Revenue for the three- and six- month periods ended June 30, 2025 were $28.2 million and $54.4 million, respectively. Revenue decreased $2.5 million and $5.4 million, or 8% and 9%, for the three- and six- month periods ended June 30, 2025 compared to the same period in 2024, respectively. The decrease in revenue was driven by lower sales activity with our OEM Channel partners, primarily J&J MedTech.
Previous wording
For the three-month period ended March 31, 2025, the loss from continuing operations was $4.0 million, compared to a loss from continuing operations of $2.0 million for the same period in 2024. The $2.0 million increase in the loss from continuing operations was due to lower revenue and higher manufacturing costs.
Current wording
For the three- and six- month periods ended June 30, 2025, the loss from continuing operations was $4.3 million and $8.6 million, respectively. For the three- and six month periods ended June 20, 2024, the loss from continuing operations was $1.8 million and $4.3 million, respectively. The increase in the loss from continuing operations was primarily due to lower revenue and higher manufacturing costs.
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-month periods ended March 31, 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 and six-month periods ended June 30, 2025 and 2024, respectively:
Previous wording
Adjusted EBITDA in the three-month period ended March 31, 2025 decreased $2.6 million as compared with the same period in 2024. The decrease in adjusted EBITDA for the period was primarily due to a decrease in OEM Channel revenues and lower gross profit. .
Current wording
Adjusted EBITDA in the three-month period ended June 30, 2025 decreased by $5.0 million as compared with the same period in 2024. The decrease in Adjusted EBITDA for the period was primarily driven by lower gross profit from lower revenue and higher manufacturing costs.
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-month periods ended March 31, 2025 and 2024, respectively:
Current 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 six-month periods ended June 30, 2025 and 2024, 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-month periods ended March 31, 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 and six-month periods ended June 30, 2025 and 2024, respectively:
Previous wording
Adjusted net income and adjusted diluted earnings per share in the three-month period ended March 31, 2025 decreased by $1.0 million and $0.19, respectively, as compared with the same period in 2024. The decrease for the period was primarily due to lower revenues and gross profit.
Current wording
Adjusted net income and adjusted diluted earnings per share in the three-month period ended June 30, 2025 decreased $2.3 million and $0.16, respectively, as compared with the same period in 2024. The decrease for the period was primarily due to lower revenues and lower 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 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 $53.4 million and $55.6 million, and working capital totaled $84.6 million and $90.3 million, at March 31, 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 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 $53.2 million and $55.6 million, and working capital totaled $83.2 million and $90.3 million, at June 30, 2025 and December 31, 2024, respectively.
Previous wording
The following changes contributed to the net change in cash and cash equivalents in the three-month period ended March 31, 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 six-month period ended June 30, 2025 as compared to the same period in 2024.
Previous wording
Cash provided by investing activities was $1.7 million for the three-month period ended March 31, 2025, as compared to cash used in investing activities of $1.8 million for the same period in 2024. The change was primarily due to proceeds of $4.5 million from the sale of Parcus Medical offset by a $1.0 million increase in capital expenditures to support manufacturing operations at our Bedford facility.
Current wording
Cash provided by investing activities was $1.1 million for the six-month period ended June 30, 2025, as compared to cash used in investing activities of $5.2 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 $4.3 million in the six-month period ended June 30, 2025 compared to $5.2 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 wording
Cash used in financing activities was $5.4 million for the three-month period ended March 31, 2025, as compared to cash used in financing activities of $2.3 million for the same period in 2024. The increase in cash used in financing activities was primarily attributable to $4.0 million used to fund the share repurchase program that began in May 2024 and the utilization of cash for employee tax withholding in exchange for shares surrendered by equity award holders.
Current wording
Cash used in financing activities was $5.3 million for the six-month period ended June 30, 2025, as compared to cash used in financing activities of $3.4 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.
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 three months ended March 31, 2025. For additional discussion, see Note 9 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 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 six months ended June 30, 2025. For additional discussion, see Note 11 to the condensed consolidated financial statements included in this report.
Rearranged current paragraphs (1)
Current report — wording carried from elsewhere
Adjusted net income and adjusted diluted earnings per share in the six-month period ended June 30, 2025 decreased $7.8 million and $0.53, respectively, as compared with the same period in 2024. The decrease for the period was primarily due to lower revenues and lower gross profit.