Organogenesis Holdings Inc.

Previous wording

We offer a comprehensive portfolio of products in the markets we serve that address patient needs across the continuum of care. We have and intend to continue to generate data from clinical trials, real-world outcomes and health economics research that validate the clinical efficacy and value proposition offered by our products. Several of our existing and pipeline products in our portfolio have PMA, or 510(k) clearance from the FDA. Given the extensive time and cost required to conduct clinical trials and receive FDA approvals, we believe that our data and regulatory approvals provide us with a strong competitive advantage. Our product development expertise and multiple technology platforms provide a robust product pipeline, which we believe will drive future growth.

Current wording

We offer a comprehensive portfolio of products in the markets we serve that address patient needs across the continuum of care. We have generated and intend to continue to generate data from clinical trials, real-world outcomes and health economics research that validate the clinical efficacy and value proposition offered by our products. Several of our existing and pipeline products in our portfolio have PMA or 510(k) clearance from the FDA. Given the extensive time and cost required to conduct clinical trials and receive FDA approvals, we believe that our data and regulatory approvals provide us with a strong competitive advantage. Our product development expertise and multiple technology platforms provide a robust product pipeline, which we believe will drive future growth.

Previous wording

In the Surgical & Sports Medicine market, we are leveraging our broad regenerative medicine capabilities to address chronic and acute surgical wounds and tendon and ligament injuries. Our Sports Medicine products include NuShield and Cygnus Matrix for surgical applications in targeted soft tissue repairs; and Affinity, PuraPly MZ, PuraPly AM, and PuraPly SX for management of open wounds in the surgical setting. We currently sell these products through independent agencies and our direct sales force.

Current wording

In the Surgical & Sports Medicine market, we are leveraging our broad regenerative medicine capabilities to address chronic and acute surgical wounds and tendon and ligament injuries. Our Surgical & Sports Medicine products include NuShield and CYGNUS Matrix for surgical applications in targeted soft tissue repairs; and Affinity, PuraPly MZ, PuraPly AM, and PuraPly SX for management of open wounds in the surgical setting. We currently sell these products through independent agencies and our direct sales force.

Previous wording

On November 5, 2025, CMS released a final rule adopting policy changes for Medicare payments under the PFS and other Medicare Part B issues, effective on or after January 1, 2026. On November 25, 2025, CMS issued a final rule that adopted policy changes for Medicare payments under the Hospital OPPS, effective on or after January 1, 2026. For calendar year 2026, under the PFS and OPPS final rules, CMS will pay for certain skin substitute products, at a payment rate of approximately $127.14 per square centimeter (prior to the application of the geographic adjustments, as applicable), as incident-to supplies when they are used as part of a covered application procedure paid in the non-facility setting or used in the hospital outpatient department and ambulatory surgery center setting. Both the PFS and OPPS final rules assign skin substitutes to categories based on their FDA regulatory status, namely 361 HCT/Ps, PMAs and 510(k)s. CMS stated that categorizing and paying for skin substitute products based on relevant product characteristics, consistent with their FDA regulatory status, recognizes the clinical and resource differences in product types and is intended to incentivize competition to create more innovative products, while also resulting in significant savings to the Medicare Trust Fund. For calendar year 2026, the final PFS and OPPS rules provide for use of a single initial payment rate across these three categories, with CMS indicating that in future years, it intends to propose payment rates that differentiate between the three FDA regulatory categories. CMS is implementing these policy changes in the non-facility setting paid under the PFS and in the hospital outpatient department and ambulatory surgical center settings paid under OPPS to remain consistent across these different sites of care. While we believe CMS’ finalized PFS and OPPS payment structure will curb abuse under the current system and the resulting rapid escalation in Medicare spending, and ensure a much-needed consistent payment approach across sites of care, the changes could also materially and adversely impact utilization of our products, our business, our revenue and our profitability.

Current wording

On November 5, 2025, CMS released a final rule adopting policy changes for Medicare payments under the PFS and other Medicare Part B issues, effective on or after January 1, 2026. On November 25, 2025, CMS issued a final rule that adopted policy changes for Medicare payments under the Hospital Outpatient Prospective Payment System (“OPPS”), effective on or after January 1, 2026. For calendar year 2026, under the PFS and OPPS final rules, CMS will pay for certain skin substitute products at a payment rate of approximately $127.14 per square centimeter (prior to the application of the geographic adjustments, as applicable), as incident-to supplies when they are used as part of a covered application procedure paid in the non-facility setting or used in the hospital outpatient department and ambulatory surgery center setting. Both the PFS and OPPS final rules assign skin substitutes to categories based on their FDA regulatory status, namely 361 HCT/Ps, PMAs and 510(k)s. CMS stated that categorizing and paying for skin substitute products based on relevant product characteristics, consistent with their FDA regulatory status, recognizes the clinical and resource differences in product types and is intended to incentivize competition to create more innovative products, while also resulting in significant savings to the Medicare Trust Fund. For calendar year 2026, the final PFS and OPPS rules provide for use of a single initial payment rate across these three categories, with CMS indicating that in future years, it intends to propose payment rates that differentiate between the three FDA regulatory categories. CMS is implementing these policy changes in the non-facility setting paid under the PFS and in the hospital outpatient department and ambulatory surgical center settings paid under OPPS to remain consistent across these different sites of care. While we believe CMS’ finalized PFS and OPPS payment structure will curb abuse under the current system and the resulting rapid escalation in Medicare spending, and ensure a much-needed consistent payment approach across sites of care, the changes could also materially and adversely impact utilization of our products, our business, our revenue and our profitability.

Previous wording

On January 1, 2026, CMS began testing the WISeR Model which uses technology-enabled prior authorization services on select Medicare services, including the use of skin substitutes. The WISeR Model will run in six states for five years and, according to CMS, is intended to reduce waste. Implementation of the WISeR Model could impact beneficiary access to our products in the applicable states, which could also materially and adversely impact utilization of our products, our business, our revenue and our profitability. On December 30, 2025, CMS published comments regarding discarded product, which have resulted in clinician confusion and material disruption in the market. While the longer-term impact of CMS’ updated 2026 Medicare reimbursement changes is still uncertain, we experienced a significant year-over-year decline in revenue in the first and second quarters of fiscal year 2026, and we are continuing to experience a significant year-over-year decline in revenue in the third quarter of fiscal year 2026.

Current wording

On January 1, 2026, CMS began testing the WISeR Model which uses technology-enabled prior authorization services on select Medicare services, including the use of skin substitutes. The WISeR Model will run in six states for five years and, according to CMS, is intended to reduce waste. Implementation of the WISeR Model could impact beneficiary access to our products in the applicable states, which could also materially and adversely impact utilization of our products, our business, our revenue and our profitability. On December 30, 2025, CMS published comments regarding discarded product, which have resulted in clinician confusion and material disruption in the market.

Previous wording

In December 2025, we completed a planned Type B meeting with the FDA, resulting in confirmation to initiate a rolling BLA for ReNu. We initiated our rolling BLA submission in December 2025 and completed the submission on April 24, 2026. During June 2026, the FDA accepted the BLA for review and assigned a PDUFA target action date of April 24, 2027.

Current wording

In December 2025, we completed a planned Type B meeting with the FDA, resulting in confirmation to initiate a rolling BLA for Amnuvx. We initiated our rolling BLA submission in December 2025 and completed the submission on April 24, 2026. During June 2026, the FDA accepted the BLA for review. During the third quarter, the FDA completed a Pre-License Inspection of our Norwood Facility and identified 18 items requiring remediation. In addition, we recently received information requests from the FDA related to the clinical data we submitted in the BLA following a mid-cycle communication teleconference. We are preparing responses to the information requests and currently expect to complete the identified remediation work in the Norwood facility by September 30, 2027. Accordingly, the PDUFA target action date is expected to be extended from April 24, 2027.

Previous wording

We derive our net product revenue from our portfolio of Advanced Wound Care and Surgical & Sports Medicine products. We primarily sell our Advanced Wound Care products through direct sales representatives who manage and maintain the sales relationships with hospitals, wound care centers, government facilities, ASCs and physician offices. We primarily sell our Surgical & Sports Medicine products through third party agencies. As of June 30, 2026, we had approximately 180 direct sales representatives and approximately 187 independent agencies and after full implementation of the latest restructuring we had approximately 148 direct sales representatives and no change to independent agencies.

Current wording

We derive our net product revenue from our portfolio of Advanced Wound Care and Surgical & Sports Medicine products. We primarily sell our Advanced Wound Care products through direct sales representatives who manage and maintain the sales relationships with hospitals, wound care centers, government facilities, ASCs and physician offices. We primarily sell our Surgical & Sports Medicine products through third-party agencies. As of September 30, 2026, we had approximately 139 direct sales representatives and approximately 181 independent agencies.

Previous wording

Grant income relates to a grant the Company received from a governmental agency during the second quarter of 2025 related to its Smithfield Facility. We expect to recognize grant income through 2026 as the Company recognizes the related expenses that the grant is intended to compensate.

Current wording

Grant income relates to a grant we received from a governmental agency during the second quarter of 2025 related to our Smithfield Facility. We expect to recognize grant income as we recognize the related expenses that the grant is intended to compensate.

Previous wording

Impairment and fair value adjustments to assets held for sale relate to the pending sale of one of our buildings located on our Canton, Massachusetts campus that was adjusted to fair market value based on current market conditions. We recorded charges related to the impairment and fair value adjustments of the property during the second quarter of 2024, each quarter of 2025 and the second quarter of 2026.

Current wording

Impairment and fair value adjustments to assets held for sale relate to the sale of one of our buildings located on our Canton, Massachusetts campus that was adjusted to its estimated fair market value, net of estimated costs to sell, based on observable market conditions. We recorded write-downs of the property during the first quarter of 2025 and additional write-downs later in 2025, and we recorded a favorable fair value adjustment of $1.2 million during the second quarter of 2026. We completed the sale of the building in July 2026 for net proceeds of $3.6 million.

Previous wording

In determining whether a valuation allowance for deferred tax assets is necessary, we analyze both positive and negative evidence related to the realization of deferred tax assets including projected future taxable income, recent financial results and estimates of future reversals of deferred tax assets and liabilities. In addition, we consider whether it is more likely than not that a tax position will be sustained on examination by taxing authorities based on the technical merits of the position. As of June 30, 2026 the Company has established a full valuation allowance against our deferred tax assets that the Company believes are more likely than not to expire before being utilized.

Current wording

In determining whether a valuation allowance for deferred tax assets is necessary, we analyze both positive and negative evidence related to the realization of deferred tax assets including projected future taxable income, recent financial results and estimates of future reversals of deferred tax assets and liabilities. In addition, we consider whether it is more likely than not that a tax position will be sustained on examination by taxing authorities based on the technical merits of the position. As of September 30, 2026, we have established a full valuation allowance against our deferred tax assets that we believe are more likely than not to expire before being utilized.

Previous wording

The following table presents a reconciliation of GAAP net loss to non-GAAP EBITDA and non-GAAP Adjusted EBITDA for each of the periods presented:

Current wording

The following table presents a reconciliation of GAAP net income (loss) to non-GAAP EBITDA and non-GAAP Adjusted EBITDA for each of the periods presented:

Previous wording

Comparison of Three and Six Months Ended June 30, 2026 and 2025

Current wording

Comparison of Three and Nine Months Ended September 30, 2026 and 2025

Previous wording

The decrease in net product revenue in the three and six months ended June 30, 2026 was primarily due to a decrease in Advanced Wound Care net product revenue attributed to continued clinician confusion and material disruption in the market following the withdrawal of the LCD coverage policies for skin substitutes and CMS published comments regarding discarded product in December 2025.

Current wording

The decrease in net product revenue in the three and nine months ended September 30, 2026 was primarily due to a decrease in Advanced Wound Care net product revenue attributed to continued clinician confusion and material disruption in the market following the withdrawal of the LCD coverage policies for skin substitutes and CMS published comments regarding discarded product in December 2025.

Previous wording

The decrease in cost of goods sold in the six months ended June 30, 2026 was primarily due to lower costs associated with the decrease in net product revenue, partially offset by increased inventory write-down adjustments for excess and obsolete inventory resulting from a facility closure and LCD regulatory changes.

Current wording

The decrease in cost of goods sold in the nine months ended September 30, 2026 was primarily due to lower costs associated with the decrease in net product revenue, partially offset by increased inventory write-down adjustments for excess and obsolete inventory resulting from a facility closure and LCD regulatory changes.

Previous wording

The decrease in gross profit in the three and six months ended June 30, 2026 as a percentage of revenue is due to volume and pricing related impacts of the Medicare reimbursement changes and product mixes.

Current wording

The decrease in gross profit in the three and nine months ended September 30, 2026 as a percentage of revenue was due to volume and pricing related impacts of the Medicare reimbursement changes and product mix.

Previous wording

The increase in research and development expenses in the three and six months ended June 30, 2026 was primarily due to pre-launch activities related to Dermagraft in our biomanufacturing facility in Smithfield, Rhode Island, terminating certain R&D programs and related vendor agreements and supporting ReNu BLA efforts.

Current wording

The increase in research and development expenses in the nine months ended September 30, 2026 was primarily due to pre-launch activities related to Dermagraft in our biomanufacturing facility in Smithfield, Rhode Island, terminating certain R&D programs and related vendor agreements and supporting Amnuvx BLA efforts.

Previous wording

The decrease in selling, general and administrative expenses in the three months ended June 30, 2026 was primarily due to a decrease in commissions and royalty, partially offset by an increase in allowance for expected credit losses, an increase in headcount-related expenses for severance and other costs associated with the Company’s restructuring activities.

Current wording

The decrease in selling, general and administrative expenses during the three and nine months ended September 30, 2026 was primarily due to a decrease in commissions and royalty expenses, as well as a decrease in headcount-related expenses resulting from the Company’s restructuring activities.

Previous wording

During the three and six months ended June 30, 2025, we recorded decreases of $1.7 million and $8.3 million, respectively, to adjust certain assets held for sale to their fair market value.

Current wording

During the three and nine months ended September 30, 2025, we recorded decreases of $0.9 million and $9.2 million, respectively, to adjust certain assets held for sale to their fair market value.

Previous wording

During the three and six months ended June 30, 2026, we recorded an increase of $1.1 million to adjust certain assets held for sale to their fair market value.

Current wording

During the three months ended September 30, 2026, we recorded no adjustments to certain assets held for sale. During the nine months ended September 30, 2026, we recorded a favorable fair value adjustment of $1.2 million to adjust certain assets held for sale to their fair market value.

Previous wording

Other income (expense) net, decreased by $0.6 million in the three months ended June 30, 2026. Other income (expense), net, decreased by $1.2 million in the six months ended June 30, 2026. The decreases resulted primarily from interest income generated from our interest-bearing sweep accounts offset by amortization of debt discount and debt issuance costs.

Current wording

Other income (expense), net, decreased by $0.6 million in the three months ended September 30, 2026. Other income (expense), net, decreased by $1.7 million in the nine months ended September 30, 2026. The decreases resulted primarily from lower interest income earned on our interest-bearing sweep accounts as a result of lower average cash balances.

Previous wording

The decrease in the income tax benefit (expense) for the three and six months ended June 30, 2026 is primarily attributable to establishing a valuation allowance against the Company’s deferred tax assets.

Current wording

The change in the income tax benefit (expense) for the nine months ended September 30, 2026 is primarily attributable to the establishment of a full valuation allowance against our deferred tax assets during the second quarter of 2026. Income tax expense for the three months ended September 30, 2026 was immaterial as a result of the full valuation allowance.

Previous wording

As of June 30, 2026, we had working capital of $139.7 million, which included $46.1 million in cash and cash equivalents. We expect that our cash on hand and other components of working capital as of June 30, 2026, plus net cash flows from product sales will be sufficient to fund our operating expenses and capital expenditure requirements for at least 12 months beyond the filing date of this Form 10-Q notwithstanding the expiration of our credit facility on August 6, 2026.

Current wording

As of September 30, 2026, we had working capital of $110.5 million, which included $21.3 million in cash and cash equivalents. We expect that our cash on hand and other components of working capital as of September 30, 2026, plus net cash flows from product sales will be sufficient to fund our operating expenses and capital expenditure requirements for at least 12 months beyond the filing date of this Form 10-Q.

Previous wording

During the six months ended June 30, 2026, net cash used in operating activities was $10.5 million, resulting from our net loss of $149.4 million and net cash provided by in connection with changes in our operating assets and liabilities of $78.6 million, partially offset by non-cash charges of $60.3 million. Changes in our operating assets and liabilities included a decrease in accounts receivable of $119.5 million, an increase in inventory of $11.8 million, a decrease in prepaid expenses and other current assets and other assets of $4.8 million, a decrease in operating lease liabilities of $3.8 million, and a decrease in accrued expenses and other current liabilities of $29.3 million and a decrease in accounts payable of $1.4 million, partially offset by an increase in other liabilities of $0.6 million.

Current wording

During the nine months ended September 30, 2026, net cash used in operating activities was $29.1 million, resulting from our net loss of $179.1 million, partially offset by net cash provided in connection with changes in our operating assets and liabilities of $71.5 million, and non-cash charges of $78.4 million. Changes in our operating assets and liabilities included a decrease in accounts receivable of $123.6 million, an increase in inventory of $14.7 million, a decrease in prepaid expenses and other current assets and other assets of $6.9 million, a decrease in operating lease liabilities of $5.8 million, a decrease in accrued expenses and other current liabilities of $31.7 million and a decrease in accounts payable of $6.9 million, partially offset by an increase in other liabilities of $0.2 million.

Previous wording

During the six months ended June 30, 2025, net cash used in operating activities was $52.8 million, resulting from our net loss of $28.2 million and net cash used in connection with changes in our operating assets and liabilities of $58.8 million, partially offset by non-cash charges of $34.3 million. Net cash used in changes in our operating assets and liabilities included an increase in inventory of $15.9 million, an increase in accounts receivable of $13.6 million, an increase in prepaid expenses and other current assets and other assets of $12.9 million, a decrease in accrued expenses and other current liabilities of $13.9 million, and a decrease in operating lease liabilities of $4.1 million, partially offset by an increase in accounts payable of $1.6 million.

Current wording

During the nine months ended September 30, 2025, net cash used in operating activities was $49.7 million, resulting from our net loss of $6.7 million and net cash used in connection with changes in our operating assets and liabilities of $88.7 million, partially offset by non-cash charges of $45.7 million. Changes in our operating assets and liabilities included an increase in accounts receivable of $64.3 million, an increase in inventory of $15.0 million, an increase in prepaid expenses and other current assets and other assets of $3.3 million, a decrease in operating lease liabilities of $6.3 million, and a decrease in accrued expenses and other current liabilities of $1.9 million, partially offset by an increase in accounts payable of $0.6 million and an increase in other liabilities of $1.5 million.

Previous wording

During the six months ended June 30, 2026, we used $4.2 million of cash in investing activities consisting exclusively of capital expenditures.

Current wording

During the nine months ended September 30, 2025, we used $9.5 million of cash in investing activities consisting exclusively of capital expenditures.

Previous wording

During the six months ended June 30, 2025, net cash used in financing activities was $2.3 million. This consisted of principal payments on finance lease obligations of $0.6 million and net cash payments associated with our stock awards activities of $1.8 million.

Current wording

During the nine months ended September 30, 2026, net cash used in financing activities was $36.2 million. This consisted of payments for landlord assets, net of tenant allowance of $24.0 million, principal payments on finance lease obligations of $10.6 million, net cash payments associated with our stock awards activities of $3.1 million, partially offset by net proceeds of $1.4 million from issuance of common stock in connection with our ATM Agreement.

Previous wording

During the six months ended June 30, 2026, net cash used in financing activities was $32.7 million. This consisted of payments for landlord assets, net of tenant allowance of $19.5 million, principal payments on finance lease obligations of $10.2 million and net cash payments associated with our stock awards activities of $3.1 million.

Current wording

During the nine months ended September 30, 2025, net cash used in financing activities was $12.6 million. This consisted of payments for landlord assets under construction, net of tenant allowance of $10.0 million, principal payments on finance lease obligations of $0.9 million and net cash payments associated with our stock awards activities of $1.6 million.

Previous wording

In August 2021, we and our subsidiaries entered into a credit agreement with SVB and several other lenders (the “Lenders”), which we refer to as the 2021 Credit Agreement. The 2021 Credit Agreement, as amended, provided for a term loan facility not to exceed $75.0 million (the “Term Loan Facility”) and a revolving credit facility not to exceed $125.0 million (the “Revolving Facility”). In November 2024, we and the Lenders amended the 2021 Credit Agreement to allow for the issuance of the Convertible Preferred Stock, and to require the repayment of the Term Loan Facility within one business day of such issuance, among other terms. We prepaid the Term Loan Facility in November 2024, and amounts borrowed under the Term Loan Facility may not be re-borrowed.

Current wording

In August 2021, we and our subsidiaries entered into a credit agreement with SVB and several other lenders (the “Lenders”), which we refer to as the 2021 Credit Agreement. The 2021 Credit Agreement, as amended, provided for a term loan facility not to exceed $75.0 million (the “Term Loan Facility”) and a revolving credit facility not to exceed $125.0 million (the “Revolving Facility”), which was reduced to $75.0 million in October 2025. In November 2024, we and the Lenders amended the 2021 Credit Agreement to allow for the issuance of the Convertible Preferred Stock, and to require the repayment of the Term Loan Facility within one business day of such issuance, among other terms. We prepaid the Term Loan Facility in November 2024, and amounts borrowed under the Term Loan Facility may not be re-borrowed. As of December 31, 2025 and August 6, 2026, the date on which the Revolving Facility expired in accordance with the terms of the credit agreement, we had no outstanding borrowings.

Previous wording

Our unaudited condensed consolidated financial statements have been prepared in accordance with GAAP. The preparation of unaudited condensed consolidated financial statements requires us to make estimates, assumptions and judgments that affect the reported amounts of assets, liabilities, and the disclosure at the date of the unaudited condensed consolidated financial statements, as well as revenue and expenses recorded during the reporting periods. Management bases its estimates, assumptions and judgments on historical experience and on various other factors that it believes to be reasonable under the circumstances. Different assumptions and judgments would change the estimates used in the preparation of our unaudited condensed consolidated financial statements, which, in turn, could materially change our results from those reported. Management evaluates its estimates, assumptions and judgments on an ongoing basis. Historically, our critical accounting estimates have not differed materially from actual results. However, if our assumptions change, we may need to revise our estimates, or take other corrective actions, either of which may also have a material adverse effect on our condensed consolidated statements of operations and comprehensive loss, liquidity and financial condition. See also our Annual Report on Form 10-K for the fiscal year ended December 31, 2025, for information about these accounting policies as well as a description of our other significant accounting policies.

Current wording

Our unaudited condensed consolidated financial statements have been prepared in accordance with GAAP. The preparation of unaudited condensed consolidated financial statements requires us to make estimates, assumptions and judgments that affect the reported amounts of assets, liabilities, and the disclosure at the date of the unaudited condensed consolidated financial statements, as well as revenue and expenses recorded during the reporting periods. Management bases its estimates, assumptions and judgments on historical experience and on various other factors that it believes to be reasonable under the circumstances. Different assumptions and judgments would change the estimates used in the preparation of our unaudited condensed consolidated financial statements, which, in turn, could materially change our results from those reported. Management evaluates its estimates, assumptions and judgments on an ongoing basis. Historically, our critical accounting estimates have not differed materially from actual results. However, if our assumptions change, we may need to revise our estimates, or take other corrective actions, either of which may also have a material adverse effect on our condensed consolidated statements of operations and comprehensive income (loss), liquidity and financial condition. See also our Annual Report on Form 10-K for the fiscal year ended December 31, 2025, for information about these accounting policies as well as a description of our other significant accounting policies.