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  Title	Organogenesis Holdings Inc. Reports Fourth Quarter 2024 Financial Results
  ID	7358605
  External ID	210500105
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  Published Date	Feb. 27, 2025, 3:05 p.m.
  Summary	Unlock stock picks and a broker-level newsfeed that powers Wall Street. Upgrade Now Organogenesis Holdings Inc. Reports Fourth Quarter 2024 Financial Results Organogenesis Holdings Inc. Thu, Feb 27, 2
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  Content ID	4663851
  Key	a6f02198-dd0e-4dbd-a5bd-c49a3df15ff4
  Content	Unlock stock picks and a broker-level newsfeed that powers Wall Street. Upgrade Now Organogenesis Holdings Inc. Reports Fourth Quarter 2024 Financial Results Organogenesis Holdings Inc. Thu, Feb 27, 2025, 4:05 PM 24 min read In This Article: ORGO +80.68% Organogenesis Holdings Inc. CANTON, Mass., Feb. 27, 2025 (GLOBE NEWSWIRE) -- Organogenesis Holdings Inc. (Nasdaq: ORGO), a leading regenerative medicine and tissue innovations company focused on empowering healing through the development, manufacturing, and sale of products for the advanced wound care, and surgical and sports medicine markets, today reported financial results for the fourth quarter and the year ended December 31, 2024. Fourth Quarter 2024 Financial Results Summary: Net revenue of $126.7 million for the fourth quarter of 2024, an increase of $27.0 million compared to net revenue of $99.7 million for the fourth quarter of 2023. Net revenue for the fourth quarter of 2024 consists of: Net revenue from Advanced Wound Care products of $118.6 million, an increase of 27% from the fourth quarter of 2023. Net revenue from Surgical & Sports Medicine products of $8.1 million, an increase of 24% from the fourth quarter of 2023. Net income of $7.7 million for the fourth quarter of 2024, compared to net loss of $0.6 million for the fourth quarter of 2023, an increase in net income of $8.3 million. Adjusted EBITDA of $18.2 million for the fourth quarter of 2024, compared to Adjusted EBITDA of $7.5 million for the fourth quarter of 2023, an increase of $10.7 million. Adjusted net income of $8.8 million for the fourth quarter of 2024, compared to adjusted net income of $1.9 million for the fourth quarter of 2023, an increase of $6.8 million. Fiscal Year 2024 Financial Results Summary: Net revenue of $482.0 million for the year ended December 31, 2024, an increase of $48.9 million compared to net revenue of $433.1 million for the year ended December 31, 2023. Net revenue for the year ended December 31, 2024 consists of: Net revenue from Advanced Wound Care products of $453.6 million, an increase of 12% year over year. Net revenue from Surgical & Sports Medicine products of $28.4 million, an increase of 3% year over year. Net income of $0.9 million for the year ended December 31, 2024, compared to net income of $4.9 million for the year ended December 31, 2023, a decrease of $4.0 million. Adjusted EBITDA of $49.8 million for the year ended December 31, 2024, compared to Adjusted EBITDA of $42.6 million for the year ended December 31, 2023, an increase of $7.2 million. Adjusted net income of $20.5 million for the year ended December 31, 2024, compared to adjusted net income of $12.7 million for the year ended December 31, 2023, an increase of $7.8 million. “Our 2024 results exceeded expectations in a difficult environment, underscoring our strong execution, brand equity and the trust of our customers to help them navigate this complex market,” said Gary S. Gillheeney, Sr., President, Chief Executive Officer and Chair of the Board for Organogenesis. “In 2025, we will continue to focus on our customers while we collaborate with policy and law makers to craft a solution that addresses spending while ensuring access to safe and effective therapies for all patients.” Story Continues Mr. Gillheeney, Sr. continued: “We expect to meet a key strategic milestone in 2025 by delivering the ReNu BLA submission by the end of the year. We believe this is a transformational opportunity for Organogenesis in that, if approved, ReNu will potentially address an unmet clinical need for all patients suffering from knee OA. ” Fourth Quarter 2024 Financial Results: Three Months Ended December 31, Change 2024 2023 $ % (in thousands, except for percentages) Advanced Wound Care $ 118,585 $ 93,165 $ 25,420 27 % Surgical & Sports Medicine 8,071 6,486 1,585 24 % Net revenue $ 126,656 $ 99,651 $ 27,005 27 % Net revenue for the fourth quarter of 2024 was $126.7 million, compared to $99.7 million for the fourth quarter of 2023, an increase of $27.0 million, or 27%. The increase in net revenue was driven by an increase of $25.4 million, or 27%, in net revenue for Advanced Wound Care products, and an increase of $1.6 million, or 24%, in net revenue for Surgical & Sports Medicine products. Gross profit for the fourth quarter of 2024 was $95.6 million, or 75% of net revenue, compared to $71.9 million, or 72% of net revenue for the fourth quarter of 2023, an increase of $23.7 million, or 33%. Operating expenses for the fourth quarter of 2024 were $85.4 million compared to $73.2 million for the fourth quarter of 2023, an increase of $12.2 million, or 17%. R&D expense was $11.5 million for the fourth quarter of 2024, compared to $11.8 million for the fourth quarter of 2023, a decrease of $0.3 million, or 3%. Selling, general and administrative expenses were $73.9 million for the fourth quarter of 2024, compared to $61.4 million for the fourth quarter of 2023, an increase of $12.5 million, or 20%. Operating income for the fourth quarter of 2024 was $10.2 million, compared to an operating loss of $1.3 million for the fourth quarter of 2023, an increase in operating income of $11.5 million, or 905%. Total other expense, net, for the fourth quarter of 2024 was less than $0.1 million, compared to $0.5 million for the fourth quarter of 2023, a decrease of $0.5 million, or 95%. Net income for the fourth quarter of 2024 was $7.7 million, or $0.05 per share, compared to a net loss of $0.6 million, or $0.00 per share, for the fourth quarter of 2023, an increase in net income of $8.3 million, or $0.05 per share. Adjusted EBITDA was $18.2 million for the fourth quarter of 2024, compared to $7.5 million for the fourth quarter of 2023, an increase of $10.7 million, or 143%. Adjusted net income was $8.8 million for the fourth quarter of 2024, compared to $1.9 million for the fourth quarter of 2023, an increase of $6.8 million, or 354%. As of December 31, 2024, the Company had $136.2 million in cash, cash equivalents and restricted cash and no outstanding debt obligations, compared to $104.3 million in cash, cash equivalents and restricted cash and $66.2 million in net debt obligations as of December 31, 2023. Fiscal Year 2024 Financial Results: Year Ended December 31, Change 2024 2023 $ % (in thousands, except for percentages) Advanced Wound Care $ 453,639 $ 405,514 $ 48,125 12 % Surgical & Sports Medicine 28,404 27,626 778 3 % Net revenue $ 482,043 $ 433,140 $ 48,903 11 % Net revenue for the year ended December 31, 2024 was $482.0 million, compared to $433.1 million for the year ended December 31, 2023, an increase of $48.9 million, or 11%. The increase in net revenue was driven by an increase of $48.1 million, or 12%, in net revenue for Advanced Wound Care products and an increase of $0.8 million, or 3%, in net revenue for Surgical & Sports Medicine products. Gross profit for the year ended December 31, 2024 was $366.3 million, or 76% of net revenue, compared to $326.7 million, or 75% of net revenue for the year ended December 31, 2023, an increase of $39.6 million, or 12%. Operating expenses for the year ended December 31, 2024 were $367.6 million compared to $314.1 million for the year ended December 31, 2023, an increase of $53.5 million or 17%. R&D expense was $50.3 million for the year ended December 31, 2024, compared to $44.4 million for the year ended December 31, 2023, an increase of $5.9 million, or 13%. Selling, general and administrative expenses were $294.5 million for the year ended December 31, 2024, compared to $269.8 million for the year ended December 31, 2023, an increase of $24.8 million, or 9%. For the year ended December 31, 2024, the Company recorded impairment and write down expenses of $18.8 million and $4.0 million, respectively. Operating loss for the year ended December 31, 2024 was $1.3 million, compared to operating income of $12.5 million for the year ended December 31, 2023, a decrease in operating income of $13.8 million, or 110%. Total other expense, net, for the year ended December 31, 2024, was $1.5 million, compared to $2.1 million for the year ended December 31, 2023, a decrease of $0.6 million, or 29%. Net income for the year ended December 31, 2024 was $0.9 million, or $(0.01) per share, compared to net income of $4.9 million or $0.04 per share, for the year ended December 31, 2023, a decrease in net income of $4.0 million, or $(0.05) per share. Adjusted EBITDA was $49.8 million for the year ended December 31, 2024, compared to $42.6 million for the year ended December 31, 2023, an increase of $7.2 million, or 17%. Adjusted net income was $20.5 million for the year ended December 31, 2024, compared to $12.7 million for the year ended December 31, 2023, an increase in adjusted net income of $7.8 million, or 61%. As of December 31, 2024, the Company had $136.2 million in cash, cash equivalents and restricted cash and no outstanding debt obligations, compared to $104.3 million in cash, cash equivalents and restricted cash and $66.2 million in net debt obligations as of December 31, 2023. Fiscal Year 2025 Guidance: For the year ending December 31, 2025, the Company expects: Net revenue between $480.0 million and $535.0 million, representing a range of roughly flat to an increase of approximately 11% year-over-year, as compared to net revenue of $482.0 million for the year ended December 31, 2024. The 2025 net revenue guidance range assumes: Net revenue from Advanced Wound Care products between $450.0 million and $500.0 million, a decrease of 1% to an increase of 10% year-over-year as compared to net revenue of $453.6 million for the year ended December 31, 2024. Net revenue from Surgical & Sports Medicine products between $30.0 million and $35.0 million, an increase of 6% to 23% year-over-year as compared to net revenue of $28.4 million for the year ended December 31, 2024. Net income between $9.5 million and $38.8 million and adjusted net income between $15.3 million and $44.6 million. EBITDA between $27.0 million and $66.6 million and Adjusted EBITDA between $43.6 million and $83.2 million. Fourth Quarter Earnings Conference Call: Management will host a conference call at 5:00 p.m. Eastern Time today to discuss the results of the quarter and fiscal year, and to provide a corporate update with a question and answer session. Those who would like to participate may access the live webcast here , or access the teleconference here . The live webcast can also be accessed via the company’s website at investors.organogenesis.com. The webcast will be archived on the company website for approximately one year. ORGANOGENESIS HOLDINGS INC. UNAUDITED CONSOLIDATED BALANCE SHEETS (amounts in thousands, except share and per share data) December 31, 2024 2023 Assets Current assets: Cash and cash equivalents $ 135,571 $ 103,840 Restricted cash 580 498 Accounts receivable, net of allowance for credit losses of $9,576 and $6,860 109,861 81,999 Inventories, net 26,219 28,253 Prepaid expenses and other current assets 13,710 10,454 Total current assets 285,941 225,044 Property and equipment, net 89,128 116,228 Intangible assets, net 12,468 15,871 Goodwill 28,772 28,772 Operating lease right-of-use assets, net 37,110 40,118 Deferred tax asset, net 39,462 28,002 Other assets 5,005 5,990 Total assets $ 497,886 $ 460,025 Liabilities, Redeemable Convertible Preferred Stock, and Stockholders’ Equity Current liabilities: Current portion of term loan $ — $ 5,486 Current portion of finance lease obligations 1,170 1,081 Current portion of operating lease obligations - related party 3,671 8,413 Current portion of operating lease obligations 4,272 4,731 Accounts payable 28,911 30,724 Accrued expenses and other current liabilities 39,453 30,074 Total current liabilities 77,477 80,509 Term loan, net of current portion — 60,745 Finance lease obligations, net of current portion 718 1,888 Operating lease obligations, net of current portion - related party 8,283 11,954 Operating lease obligations, net of current portion 25,198 25,053 Other liabilities 894 1,213 Total liabilities 112,570 181,362 Commitments and contingencies (Note 20) Series A redeemable convertible preferred stock, $0.0001 par value; 130,000 and 0 shares authorized, issued and outstanding at December 31, 2024 and 2023, respectively; liquidation preference of $131,387 and $0 at December 31, 2024 and 2023, respectively. 122,419 — Stockholders’ equity: Preferred stock, $0.0001 par value; 870,000 and 1,000,000 shares authorized at December 31, 2024 and 2023, respectively; none issued or outstanding — — Common stock, $0.0001 par value; 400,000,000 shares authorized; 126,458,784 and 132,044,944 shares issued; 125,730,236 and 131,316,396 shares outstanding at December 31, 2024 and 2023, respectively 13 13 Additional paid-in capital 302,994 319,621 Accumulated deficit (40,110 ) (40,971 ) Total stockholders' equity 262,897 278,663 Total liabilities, redeemable convertible preferred stock, and stockholders' equity $ 497,886 $ 460,025 ORGANOGENESIS HOLDINGS INC. UNAUDITED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS) (amounts in thousands, except share and per share data) Three Months Ended December 31, Year Ended December 31, 2024 2023 2024 2023 Net revenue $ 126,656 $ 99,651 $ 482,043 $ 433,140 Cost of goods sold 31,051 27,769 115,741 106,481 Gross profit 95,605 71,882 366,302 326,659 Operating expenses: Selling, general and administrative 73,856 61,381 294,513 269,754 Research and development 11,530 11,770 50,271 44,380 Impairment of property and construction — — 18,842 — Write down of capitalized internal-use software costs — — 3,959 — Total operating expenses 85,386 73,151 367,585 314,134 Income (loss) from operations 10,219 (1,269 ) (1,283 ) 12,525 Other expense, net: Interest expense, net 61 (502 ) (1,544 ) (2,190 ) Other income (expense), net (27 ) (25 ) 20 57 Total other income (expense), net 34 (527 ) (1,524 ) (2,133 ) Net income (loss) before income taxes 10,253 (1,796 ) (2,807 ) 10,392 Income tax (expense) benefit (2,580 ) 1,228 3,668 (5,447 ) Net income (loss) and comprehensive income (loss) $ 7,673 $ (568 ) $ 861 $ 4,945 Accretion of redeemable convertible preferred stock to redemption value (412 ) — (412 ) — Cumulative dividend on redeemable convertible preferred stock (1,386 ) — (1,386 ) — Net income (loss) attributable to common stockholders 5,875 (568 ) (937 ) 4,945 Net income (loss), per share: Basic $ 0.05 $ 0.00 $ (0.01 ) $ 0.04 Diluted $ 0.04 $ 0.00 $ (0.01 ) $ 0.04 Weighted-average common shares outstanding Basic 129,679,843 130,916,950 131,673,278 131,231,317 Diluted 132,162,370 131,857,509 131,673,278 132,746,727 ORGANOGENESIS HOLDINGS INC. UNAUDITED CONSOLIDATED STATEMENT OF CASH FLOWS (amounts in thousands, except share and per share data) Year Ended December 31, 2024 2023 2022 Cash flows from operating activities: Net income $ 861 $ 4,945 $ 15,532 Adjustments to reconcile net income to net cash provided by operating activities: Depreciation and amortization 13,623 10,448 5,845 Amortization of intangible assets 3,403 4,918 4,883 Reduction in the carrying value of right-of-use assets 8,348 8,083 7,303 Non-cash interest expense 394 427 434 Deferred interest expense 305 490 501 Deferred tax expense (benefit) (10,719 ) 2,012 1,980 Loss on disposal of property and equipment 1,140 235 4,482 Loss on lease termination — 559 — Loss on extinguishment of term loan 215 — — Provision recorded for credit losses 3,938 1,297 1,781 Adjustment for excess and obsolete inventories 8,210 6,580 9,648 Stock-based compensation 10,578 8,996 6,552 Impairment of property and construction (Note 8) 18,842 — — Write down of capitalized internal-use software costs (Note 8) 3,959 — — Changes in operating assets and liabilities: Accounts receivable (31,800 ) 5,539 (8,770 ) Inventories (6,204 ) (8,179 ) (9,410 ) Prepaid expenses and other current and other assets (2,549 ) (10,115 ) (378 ) Operating leases (14,066 ) (8,439 ) (7,006 ) Accounts payable (2,372 ) (108 ) 3,260 Accrued expenses and other current liabilities 9,164 3,138 (11,850 ) Other liabilities (1,062 ) 91 72 Net cash provided by operating activities 14,208 30,917 24,859 Cash flows from investing activities: Purchases of property and equipment (10,032 ) (24,364 ) (33,898 ) Net cash used in investing activities (10,032 ) (24,364 ) (33,898 ) Cash flows from financing activities: Term loan repayments under the 2021 Credit Agreement (66,563 ) (4,688 ) (2,813 ) Proceeds from issuance of redeemable convertible preferred stock, net of issuance costs 120,688 — — Payments for the repurchase of common stock (25,479 ) — — Principal repayments of finance lease obligations (1,081 ) (485 ) (200 ) Proceeds from the exercise of stock options 1,247 — 2,070 Payments of withholding taxes in connection with RSUs vesting (1,175 ) (332 ) (648 ) Payments of deferred acquisition consideration — — (608 ) Net cash provided by (used in) financing activities 27,637 (5,505 ) (2,199 ) Change in cash, cash equivalents and restricted cash 31,813 1,048 (11,238 ) Cash, cash equivalents, and restricted cash, beginning of year 104,338 103,290 114,528 Cash, cash equivalents, and restricted cash, end of year $ 136,151 $ 104,338 $ 103,290 Supplemental disclosure of cash flow information: Cash paid for interest $ 4,970 $ 5,436 $ 2,649 Cash paid for income taxes $ 6,965 $ 3,052 $ 1,201 Supplemental disclosure of non-cash investing and financing activities: Cumulative effect adjustment for adoption of ASU No. 2016-13 $ — $ 615 $ — Deferred acquisition consideration and earnout liability recorded for business acquisition $ — $ — $ 828 Change in purchases of property and equipment included in accounts payable and accrued expenses and other current liabilities $ (432 ) $ 841 $ 1,928 Right-of-use assets obtained through operating lease obligations $ 5,109 $ 5,869 $ 1,350 Right-of-use assets obtained through finance lease obligations $ — $ 3,454 $ — Redeemable convertible preferred stock issuance costs included in accrued expenses $ 67 $ — $ — Prepaid rent reclassified to right-of-use assets $ 230 $ — $ — Accretion to redemption value and cumulative dividends on redeemable convertible preferred stock $ 1,798 $ — $ — Non-GAAP Financial Measures Our management uses financial measures that are not in accordance with generally accepted accounting principles in the United States, or GAAP, in addition to financial measures in accordance with GAAP to evaluate our operating results. These non-GAAP financial measures should be considered supplemental to, and not a substitute for, our reported financial results prepared in accordance with GAAP. Our management uses Adjusted EBITDA and Adjusted net income to evaluate our operating performance and trends and make planning decisions. Our management believes Adjusted EBITDA and Adjusted net income help identify underlying trends in our business that could otherwise be masked by the effect of the items that we exclude. Accordingly, we believe that Adjusted EBITDA and Adjusted net income provide useful information to investors and others in understanding and evaluating our operating results, enhancing the overall understanding of our past performance and prospects, and allowing for greater transparency with respect to key financial metrics used by our management in its financial and operational decision-making. Adjusted EBITDA Adjusted EBITDA consists of GAAP net income excluding: (i) interest expense, net, (ii) income tax expense, (iii) depreciation and amortization, (iv) amortization of intangible assets, (v) stock-based compensation expense, and (vi) additional infrequently occurring adjustments described in more detail below. The following table presents a reconciliation of GAAP net income to non-GAAP EBITDA and non-GAAP Adjusted EBITDA, for the periods presented: Three Months Ended December 31, Year Ended December 31, ($, in thousands) 2024 2023 2024 2023 Net income (loss) $ 7,673 $ (568 ) $ 861 $ 4,945 Interest expense, net (61 ) 502 1,544 2,190 Income tax expense 2,580 (1,228 ) (3,668 ) 5,447 Depreciation and amortization 3,615 2,982 13,623 10,448 Amortization of intangible assets 834 1,229 3,403 4,918 EBITDA 14,641 2,917 15,763 27,948 Stock-based compensation expense 2,891 2,366 10,578 8,996 Restructuring charge (1) — 1,918 — 3,796 Legal fees (2) — — — 1,182 Sales retention (3) — 272 — 694 Impairment of property and construction (4) — — 18,842 — Write down of capitalized internal-use software costs (5) — — 3,959 — Disposal of construction in progress (6) 645 — 645 — Adjusted EBITDA $ 18,177 $ 7,473 $ 49,787 $ 42,616 (1)  Amounts reflect employee retention and benefits as well as other exit costs associated with our restructuring activities. (2)  Amount reflects the legal and consulting fees incurred related to the published and subsequently withdrawn 2023 local coverage determinations, or LCDs. (3)  Amount reflects the compensation expenses related to retention for those sales employees impacted by the published and subsequently withdrawn 2023 LCDs. (4)  Amount reflects the impairment of a purchased building and associated unfinished construction work. (5)  Amount reflects the write-down of costs previously capitalized as construction in progress in the development of internal-use software, that we determined have no future value. (6)  Amount reflects construction in progress terminated and disposed of at one of our Canton, Massachusetts facilities, resulting from our decision to move certain operations to the Smithfield Facility. Adjusted net income Adjusted net income is defined as GAAP net income (loss) plus (i) amortization of intangible assets and (ii) additional infrequently occurring adjustments described in more detail below, less the estimated tax on these adjustments. The following table presents a reconciliation of GAAP net income (loss) to non-GAAP Adjusted net income, for the periods presented: Three Months Ended December 31, Year Ended December 31, ($, in thousands) 2024 2023 2024 2023 Net income (loss) $ 7,673 $ (568 ) $ 861 $ 4,945 Amortization of intangible assets 834 1,229 3,403 4,918 Restructuring charge (1) — 1,918 — 3,796 Legal fees (2) — — — 1,182 Sales retention (3) — 272 — 694 Impairment of property and construction (4) — — 18,842 — Write down of capitalized internal-use software costs (5) — — 3,959 — Disposal of construction in progress (6) 645 — 645 — Tax on above (399 ) (923 ) (7,249 ) (2,859 ) Adjusted net income $ 8,753 $ 1,928 $ 20,461 $ 12,676 (1)  Amounts reflect employee retention and benefits as well as other exit costs associated with our restructuring activities. (2)  Amount reflects the legal and consulting fees incurred related to the published and subsequently withdrawn 2023 LCDs. (3)  Amount reflects the compensation expenses related to retention for those sales employees impacted by the published and subsequently withdrawn 2023 LCDs. (4)  Amount reflects the impairment of a purchased building and associated unfinished construction work. (5)  Amount reflects the write-down of costs previously capitalized as construction in progress in the development of internal-use software, that we determined have no future value. (6)  Amount reflects construction in progress terminated and disposed of at one of our Canton, Massachusetts facilities, resulting from our decision to move certain operations to the Smithfield Facility. Projected EBITDA and Adjusted EBITDA The following table presents a reconciliation of projected GAAP net income (loss) to projected non-GAAP EBITDA and projected non-GAAP Adjusted EBITDA included in our guidance for the year ending December 31, 2025: Year Ended December 31, ($, in thousands) 2025L 2025H Net income $ 9,500 $ 38,800 Interest income (4,000 ) (4,000 ) Income tax expense 3,400 13,600 Depreciation and amortization 14,800 14,800 Amortization of intangible assets 3,300 3,300 EBITDA 27,000 66,600 Stock-based compensation expense 12,000 12,000 BLA submission fee to the FDA 4,600 4,600 Adjusted EBITDA 43,600 83,200 Note: Numbers may not foot or recalculate due to rounding. Projected Adjusted Net Income (Loss) The following table presents a reconciliation of projected GAAP net loss to projected non-GAAP adjusted net income included in our guidance for the year ending December 31, 2025: Year Ended December 31, ($, in thousands) 2025L 2025H Net income $ 9,500 $ 38,800 Amortization of intangible assets 3,300 3,300 BLA submission fee to the FDA 4,600 4,600 Tax on above (2,100 ) (2,100 ) Adjusted net (loss) income $ 15,300 $ 44,600 Note: Numbers may not foot or recalculate due to rounding. Forward-Looking Statements This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements relate to expectations or forecasts of future events. Forward-looking statements may be identified by the use of words such as “forecast,” “intend,” “seek,” “target,” “anticipate,” “believe,” “expect,” “estimate,” “plan,” “outlook,” and “project” and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. Such forward-looking statements include statements relating to the Company’s expected revenue, net income (loss), Adjusted net income, EBITDA, and Adjusted EBITDA for fiscal 2024 and the breakdown of expected revenue in both its Advanced Wound Care and Surgical & Sports Medicine categories. Forward-looking statements with respect to the operations of the Company, strategies, prospects, and other aspects of the business of the Company are based on current expectations that are subject to known and unknown risks and uncertainties, which could cause actual results or outcomes to differ materially from expectations expressed or implied by such forward-looking statements. These factors include, but are not limited to: (1) the impact of any changes to the coverage and reimbursement levels for the Company’s products (including as a result of the recently proposed LCDs scheduled to take effect in April 2025); (2) the Company faces significant and continuing competition, which could adversely affect its business, results of operations and financial condition; (3) rapid technological change could cause the Company’s products to become obsolete and if the Company does not enhance its product offerings through its research and development efforts, it may be unable to effectively compete; (4) to be commercially successful, the Company must convince physicians that its products are safe and effective alternatives to existing treatments and that its products should be used in their procedures; (5) the Company’s ability to raise funds to expand its business; (6) the Company has incurred losses in the current period and prior periods and may incur losses in the future; (7) changes in applicable laws or regulations; (8) the possibility that the Company may be adversely affected by other economic, business, and/or competitive factors; (9) the Company’s ability to maintain production or obtain supply of its products in sufficient quantities to meet demand; (10) the impact of the suspension of commercialization of: (a) ReNu and NuCel in connection with the expiration of the FDA’s enforcement grace period for HCT/Ps on May 31, 2021 and (b) Dermagraft in the second quarter of 2022 pending transition of manufacturing to a new manufacturing facility or a third-party manufacturer; (11) whether the Company is able to obtain regulatory approval for and successfully commercialize ReNu; and (12) other risks and uncertainties described in the Company’s filings with the Securities and Exchange Commission, including Item 1A (Risk Factors) of the Company’s Form 10-K for the year ended December 31, 2024 and its subsequently filed periodic reports. You are cautioned not to place undue reliance upon any forward-looking statements, which speak only as of the date made. Although it may voluntarily do so from time to time, the Company undertakes no commitment to update or revise the forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable securities laws. About Organogenesis Holdings Inc. Organogenesis Holdings Inc. is a leading regenerative medicine company focused on the development, manufacture, and commercialization of solutions for the advanced wound care and surgical and sports medicine markets. Organogenesis offers a comprehensive portfolio of innovative regenerative products to address patient needs across the continuum of care. For more information, visit www.organogenesis.com . CONTACT: Investor Inquiries: ICR Healthcare Mike Piccinino, CFA OrganoIR@ICRHealthcare.com 443-213-0500 Press and Media Inquiries: Organogenesis communications@organo.com View Comments Terms and Privacy Policy Your Privacy Choices More Info Recommended Stories
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