• Organogenesis Holdings Inc. Reports Fourth Quarter 2024 Financial Results

    Source: Nasdaq GlobeNewswire / 27 Feb 2025 16:05:01   America/New_York

    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.”

    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.


    Investor Inquiries:
    ICR Healthcare
    Mike Piccinino, CFA
    OrganoIR@ICRHealthcare.com
    443-213-0500
    
    Press and Media Inquiries:
    Organogenesis
    communications@organo.com

    Primary Logo

Share on,