• Organogenesis Holdings Inc. Reports Third Quarter 2024 Financial Results

    ソース: Nasdaq GlobeNewswire / 12 11 2024 16:05:01   America/New_York

    CANTON, Mass., Nov. 12, 2024 (GLOBE NEWSWIRE) -- Organogenesis Holdings Inc. (Nasdaq: ORGO), a leading regenerative medicine company focused on the development, manufacture, and commercialization of product solutions for the Advanced Wound Care and Surgical & Sports Medicine markets, today reported financial results for the third quarter ended September 30, 2024.

    Third Quarter 2024 Financial Results Summary:

    • Net revenue of $115.2 million for the third quarter of 2024, an increase of $6.6 million compared to net revenue of $108.5 million for the third quarter of 2023. Net revenue for the third quarter of 2024 consists of:
      • Net revenue from Advanced Wound Care products of $108.0 million, an increase of 7% from the third quarter of 2023.
      • Net revenue from Surgical & Sports Medicine products of $7.2 million, an increase of 1% from the third quarter of 2023.
    • Net income of $12.3 million for the third quarter of 2024, compared to net income of $3.2 million for the third quarter of 2023, an increase in net income of $9.1 million.
    • Adjusted net income of $12.9 million for the third quarter of 2024, compared to adjusted net income of $5.3 million for the third quarter of 2023, an increase in adjusted net income of $7.6 million.
    • Adjusted EBITDA of $13.4 million for the third quarter of 2024, compared to Adjusted EBITDA of $16.0 million for the third quarter of 2023, a decrease of $2.6 million.

    “Our third quarter results underscore the strength of our portfolio and brand equity as customers select Organogenesis as their trusted partner while they navigate this complex market,” said Gary S. Gillheeney, Sr., President, Chief Executive Officer and Chair of the Board for Organogenesis. “We continue to work with policy and lawmakers to craft a solution that addresses spending while ensuring access to safe and effective therapies for all patients, particularly those who are most vulnerable. We believe a resolution is on the horizon.”

    Third Quarter 2024 Financial Results:

      Three Months Ended September 30,  Change 
      2024  2023  $  % 
      (in thousands, except for percentages) 
    Advanced Wound Care $107,953  $101,357  $6,596   7% 
    Surgical & Sports Medicine  7,224   7,174   50   1% 
    Net revenue $115,177  $108,531  $6,646   6% 


    Net revenue for the third quarter of 2024 was $115.2 million, compared to $108.5 million for the third quarter of 2023, an increase of $6.6 million, or 6%. The increase in net revenue was driven by an increase of $6.6 million, or 7%, in net revenue for Advanced Wound Care products, and an increase of $0.1 million, or 1%, in net revenue for Surgical & Sports Medicine products.

    Gross profit for the third quarter of 2024 was $88.4 million, or 77% of net revenue, compared to $82.7 million, or 76% of net revenue for the third quarter of 2023, an increase of $5.6 million, or 7%.

    Operating expenses for the third quarter of 2024 were $82.1 million compared to $74.7 million for the third quarter of 2023, an increase of $7.4 million, or 10%. R&D expense was $10.3 million for the third quarter of 2024, compared to $10.5 million for the third quarter of 2023, a decrease of $0.2 million, or 2%. Selling, general and administrative expenses were $71.8 million for the third quarter of 2024, compared to $64.2 million for the third quarter of 2023, an increase of $7.6 million, or 12%.

    Operating income for the third quarter of 2024 was $6.2 million, compared to $8.1 million for the third quarter of 2023, a decrease of $1.8 million, or 22%.

    Total other expense, net, for the third quarter of 2024 was $0.4 million, relatively consistent with $0.4 million for the third quarter of 2023.

    Net income for the third quarter of 2024 was $12.3 million, or $0.09 per share, compared to $3.2 million, or $0.02 per share, for the third quarter of 2023, an increase of $9.1 million, or $0.07 per share.

    Adjusted EBITDA was $13.4 million for the third quarter of 2024, compared to $16.0 million for the third quarter of 2023, a decrease of $2.6 million, or 16%.

    Adjusted net income was $12.9 million for the third quarter of 2024, compared to $5.3 million for the third quarter of 2023, an increase of $7.6 million, or 143%.

    Non-GAAP operating income was $7.1 million for the third quarter of 2024, compared to $11.0 million for the third quarter of 2023, a decrease of $3.9 million, or 35%.

    As of September 30, 2024, the Company had $94.9 million in cash, cash equivalents and restricted cash and $62.1 million in net 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.

    Nine Months ended September 30, 2024, Financial Results:

      Nine Months Ended September 30,  Change 
      2024  2023  $  % 
      (in thousands, except for percentages) 
    Advanced Wound Care $335,054  $312,349  $22,705   7% 
    Surgical & Sports Medicine  20,333   21,140   (807)  (4%) 
    Net revenue $355,387  $333,489  $21,898   7% 


    Net revenue for the nine months ended September 30, 2024 was $355.4 million, compared to $333.5 million for the nine months ended September 30, 2023, an increase of $21.9 million, or 7%. The increase in net revenue was driven by an increase of $22.7 million, or 7%, in net revenue for Advanced Wound Care products partially offset by a decrease of $0.8 million, or 4%, in net revenue for Surgical & Sports Medicine products.

    Gross profit for the nine months ended September 30, 2024 was $270.7 million, or 76% of net revenue, compared to $254.8 million, or 76% of net revenue for nine months ended September 30, 2023, an increase of $15.9 million, or 6%.

    Operating expenses for the nine months ended September 30, 2024 were $282.2 million compared to $241.0 million for the nine months ended September 30, 2023, an increase of $41.2 million or 17%. R&D expense was $38.7 million for the nine months ended September 30, 2024, compared to $32.6 million for the nine months ended September 30, 2023, an increase of $6.1 million, or 19%. Selling, general and administrative expenses were $220.7 million for the nine months ended September 30, 2024, compared to $208.4 million for the nine months ended September 30, 2023, an increase of $12.3 million, or 6%. For the nine months ended September 30, 2024, the Company recorded impairment and write down expenses of $18.8 million and $4.0 million, respectively.

    Operating loss for the nine months ended September 30, 2024 was $11.5 million, compared to operating income of $13.8 million for the nine months ended September 30, 2023, a decrease in operating income of $25.3 million, or 183%.

    Total other expense, net, for the nine months ended September 30, 2024 was $1.6 million, consistent with $1.6 million for the nine months ended September 30, 2023.

    Net loss for the nine months ended September 30, 2024 was $6.8 million, or $(0.05) per share, compared to net income of $5.5 million or $0.04 per share, for the nine months ended September 30, 2023, a decrease in net income of $12.3 million, or $(0.09) per share.

    Adjusted EBITDA was $31.6 million for the nine months ended September 30, 2024, compared to $35.1 million for the nine months ended September 30, 2023, a decrease of $3.5 million, or 10%.

    Adjusted net income was $11.7 million for the nine months ended September 30, 2024, compared to $10.7 million for the nine months ended September 30, 2023, an increase in adjusted net income of $1.0 million, or 9%.

    Non-GAAP operating income was $13.9 million for the nine months ended September 30, 2024, compared to $21.0 million for the nine months ended September 30, 2023, a decrease of $7.1 million, or 34%.

    As of September 30, 2024, the Company had $94.9 million in cash, cash equivalents and restricted cash and $62.1 million in net 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 Guidance:

    For the year ending December 31, 2024 the Company is updating its prior revenue guidance and updating its profitability guidance and expects:

    • Net revenue between $455.0 million and $480.0 million, representing an increase of approximately 5% to 11% year-over-year, as compared to net revenue of $433.1 million for the year ended December 31, 2023.
      • The 2024 net revenue guidance range assumes:
        • Net revenue from Advanced Wound Care products between $429.0 million and $452.0 million, an increase of 6% to 11% year-over-year as compared to net revenue of $405.5 million for the year ended December 31, 2023.
        • Net revenue from Surgical & Sports Medicine products between $26.0 million and $28.0 million, a decrease of 7% to 0% year-over-year as compared to net revenue of $27.6 million for the year ended December 31, 2023.
    • Net loss between $12.3 million and $0.6 million and adjusted net income between $6.7 million and $18.4 million.
    • EBITDA between $(1.3) million and $14.4 million and Adjusted EBITDA between $31.7 million and $47.4 million.

    Third Quarter Earnings Conference Call:

    Management will host a conference call at 5:00 p.m. Eastern Time on November 12th to discuss the results of the quarter, and provide a corporate update with a question and answer session. To access the live webcast or to register to obtain a unique pin number and telephone dial-in to access the live teleconference, visit the ‘Investors’ section of the Company’s website (investors.organogenesis.com). The webcast will be archived on the Company’s website for approximately one year.


    ORGANOGENESIS HOLDINGS INC.
    UNAUDITED CONSOLIDATED BALANCE SHEETS
    (amounts in thousands, except share and per share data)

      September 30,  December 31, 
      2024  2023 
    Assets      
    Current assets:      
    Cash and cash equivalents $94,340  $103,840 
    Restricted cash  586   498 
    Accounts receivable, net  101,272   81,999 
    Inventories, net  27,036   28,253 
    Prepaid expenses and other current assets  15,275   10,454 
    Total current assets  238,509   225,044 
    Property and equipment, net  89,868   116,228 
    Intangible assets, net  13,302   15,871 
    Goodwill  28,772   28,772 
    Operating lease right-of-use assets, net  34,943   40,118 
    Deferred tax asset, net  35,889   28,002 
    Other assets  5,013   5,990 
    Total assets $446,296  $460,025 
    Liabilities and Stockholders’ Equity      
    Current liabilities:      
    Current portion of term loan $5,964  $5,486 
    Current portion of finance lease obligations  1,147   1,081 
    Current portion of operating lease obligations - related party  6,172   8,413 
    Current portion of operating lease obligations  3,926   4,731 
    Accounts payable  23,971   30,724 
    Accrued expenses and other current liabilities  36,101   30,074 
    Total current liabilities  77,281   80,509 
    Term loan, net of current portion  56,153   60,745 
    Finance lease obligations, net of current portion  1,019   1,888 
    Operating lease obligations, net of current portion - related party  9,217   11,954 
    Operating lease obligations, net of current portion  22,785   25,053 
    Other liabilities  1,294   1,213 
    Total liabilities  167,749   181,362 
    Commitments and contingencies (Note 15)      
    Stockholders’ equity:      
    Preferred stock, $0.0001 par value; 1,000,000 shares authorized; none issued  —   — 
    Common stock, $0.0001 par value; 400,000,000 shares authorized; 133,305,050 and 132,044,944 shares issued; 132,576,502 and 131,316,396 shares outstanding at September 30, 2024 and December 31, 2023, respectively  13   13 
    Additional paid-in capital  326,317   319,621 
    Accumulated deficit  (47,783)  (40,971)
    Total stockholders’ equity  278,547   278,663 
    Total liabilities and stockholders’ equity $446,296  $460,025 


    ORGANOGENESIS HOLDINGS INC.
    UNAUDITED     CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
    (amounts in thousands, except share and per share data)

      Three Months Ended
    September 30,    		  Nine Months Ended
    September 30,    		 
      2024  2023  2024  2023 
    Net revenue $115,177  $108,531  $355,387  $333,489 
    Cost of goods sold  26,796   25,789   84,690   78,712 
    Gross profit  88,381   82,742   270,697   254,777 
    Operating expenses:            
    Selling, general and administrative  71,795   64,222   220,657   208,373 
    Research and development  10,344   10,470   38,741   32,610 
    Impairment of property and construction  —   —   18,842   — 
    Write down of capitalized internal-use software costs  —   —   3,959   — 
    Total operating expenses  82,139   74,692   282,199   240,983 
    Income (loss) from operations  6,242   8,050   (11,502)  13,794 
    Other expense, net:            
    Interest expense, net  (471)  (444)  (1,605)  (1,688)
    Other income, net  52   31   47   82 
    Total other expense, net  (419)  (413)  (1,558)  (1,606)
    Net income (loss) before income taxes  5,823   7,637   (13,060)  12,188 
    Income tax benefit (expense)  6,508   (4,470)  6,248   (6,675)
    Net income (loss) and comprehensive income (loss) $12,331  $3,167  $(6,812) $5,513 
                 
    Net income (loss) per share:            
    Basic $0.09  $0.02  $(0.05) $0.04 
    Diluted $0.09  $0.02  $(0.05) $0.04 
    Weighted-average common shares outstanding            
    Basic  132,575,301   131,312,483   132,342,203   131,230,882 
    Diluted  133,926,755   133,417,721   132,342,203   132,790,296 


    ORGANOGENESIS HOLDINGS INC.
    UNAUDITED CONSOLIDATED STATEMENT OF CASH FLOWS
    (amounts in thousands, except share and per share data)

      Nine Months Ended
    September 30,    		 
      2024  2023 
    Cash flows from operating activities:      
    Net income (loss) $(6,812) $5,513 
    Adjustments to reconcile net income (loss) to net cash provided by operating activities:      
    Depreciation and amortization  10,008   7,466 
    Amortization of intangible assets  2,569   3,688 
    Reduction in the carrying value of right-of-use assets  6,377   5,964 
    Non-cash interest expense  313   321 
    Deferred interest expense  274   367 
    Provision recorded for credit losses  3,723   1,320 
    Deferred tax benefit  (7,887)  — 
    Loss on disposal of property and equipment  444   104 
    Adjustment for excess and obsolete inventories  5,884   4,351 
    Stock-based compensation  7,687   6,630 
    Impairment of property and construction (Note 6)  18,842   — 
    Write down of capitalized internal-use software costs (Note 6)  3,959   — 
    Changes in operating assets and liabilities:      
    Accounts receivable  (22,996)  (1,761)
    Inventories  (5,749)  (7,473)
    Prepaid expenses and other current assets and other assets  (4,052)  (4,491)
    Operating leases  (9,253)  (6,282)
    Accounts payable  (6,022)  (3,661)
    Accrued expenses and other current liabilities  5,882   8,179 
    Other liabilities  80   68 
    Net cash provided by operating activities  3,271   20,303 
    Cash flows from investing activities:      
    Purchases of property and equipment  (6,671)  (21,040)
    Net cash used in investing activities  (6,671)  (21,040)
    Cash flows from financing activities:      
    Payments of term loan under the 2021 Credit Agreement  (4,219)  (3,281)
    Principal repayments of finance lease obligations  (804)  (114)
    Payments of withholding taxes in connection with RSUs vesting  (1,173)  (333)
    Proceeds from the exercise of stock options  184   — 
    Net cash used in financing activities  (6,012)  (3,728)
    Change in cash, cash equivalents and restricted cash  (9,412)  (4,465)
    Cash, cash equivalents, and restricted cash, beginning of period  104,338   103,290 
    Cash, cash equivalents, and restricted cash, end of period $94,926  $98,825 
    Supplemental disclosure of cash flow information:      
    Cash paid for interest $4,105  $3,896 
    Cash paid for income taxes $5,493  $3,021 
    Supplemental disclosure of non-cash investing and financing activities:      
    Cumulative effect adjustment for adoption of ASU No. 2016-13 $—  $615 
    Change in purchases of property and equipment included in accounts payable and accrued expenses and other current liabilities $(222) $4,146 
    Right-of-use assets obtained through operating lease obligations $1,201  $5,138 
             

    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, Adjusted net income, and non-GAAP operating income to evaluate our operating performance and trends and make planning decisions. Our management believes Adjusted EBITDA, Adjusted net income, and non-GAAP operating 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, Adjusted net income, and non-GAAP operating 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 (loss) excluding: (i) interest expense, net, (ii) income tax benefit (expense), (iii) depreciation and amortization, (iv) amortization of intangible assets, (v) stock-based compensation expense, (vi) restructuring charges, (vii) legal fees related to the issued and subsequently withdrawn local coverage determinations (LCDs), (viii) compensation expenses related to retention for sales employees impacted by the issued and subsequently withdrawn LCDs, (ix) impairment of a purchased building and improvements and (x) write-down of capitalized software costs.

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

      Three Months Ended
    September 30,    		  Nine Months Ended
    September 30,    		 
      2024  2023  2024  2023 
      (Unaudited, in thousands) 
    Net income (loss) $12,331  $3,167  $(6,812) $5,513 
    Interest expense, net  471   444   1,605   1,688 
    Income tax benefit (expense)  (6,508)  4,470   (6,248)  6,675 
    Depreciation and amortization  3,570   2,544   10,008   7,466 
    Amortization of intangible assets  834   1,229   2,569   3,688 
    EBITDA  10,698   11,854   1,122   25,030 
    Stock-based compensation expense  2,712   2,417   7,687   6,630 
    Restructuring charge (1)  —   95   —   1,878 
    Legal fees (2)  —   1,182   —   1,182 
    Sales retention (3)  —   422   —   422 
    Impairment of building and improvements (4)  —   —   18,842   — 
    Write-down of capitalized software costs (5)  —   —   3,959   — 
    Adjusted EBITDA $13,410  $15,970  $31,610  $35,142 
     
    1. Amount reflects employee severance, retention and benefits as well as other exit costs associated with the Company’s restructuring activities.
    2. Amount represents the legal fees incurred related to the issued and subsequently withdrawn LCDs.
    3. Amount represents the compensation expenses related to retention for those sales employees impacted by the issued and subsequently withdrawn 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 in the development of internal-use software, that the Company determined have no future value.

    Adjusted Net Income (Loss)

    Adjusted Net Income (Loss) is defined as GAAP net income (loss) plus (i) amortization of intangible assets, (ii) restructuring charges, (iii) legal fees related to the issued and subsequently withdrawn LCDs, (iv) compensation expenses related to retention for sales employees impacted by the issued and subsequently withdrawn LCDs, (v) impairment of a purchased building and improvements and (vi) write-down of capitalized software costs less the estimated tax on the above.

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

      Three Months Ended September 30,  Nine Months Ended September 30, 
      2024  2023  2024  2023 
      (Unaudited, in thousands) 
    Net income (loss) $12,331  $3,167  $(6,812) $5,513 
    Amortization of intangible assets  834   1,229   2,569   3,688 
    Restructuring charge (1)  —   95   —   1,878 
    Legal fees (2)  —   1,182   —   1,182 
    Sales retention (3)  —   422   —   422 
    Impairment of building and improvements (4)  —   —   18,842   — 
    Write-down of capitalized software costs (5)  —   —   3,959   — 
    Tax on above  (225)  (791)  (6,850)  (1,936)
    Adjusted net income $12,940  $5,304  $11,708  $10,747 
     
    1. Amount reflects employee severance, retention and benefits as well as other exit costs associated with the Company’s restructuring activities.
    2. Amount represents the legal fees incurred related to the issued and subsequently withdrawn LCDs.
    3. Amount represents the compensation expenses related to retention for those sales employees impacted by the issued and subsequently withdrawn 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 in the development of internal-use software, that the Company determined have no future value.

    Non-GAAP Operating Income (Loss)

    Non-GAAP operating income (loss) is defined as GAAP income (loss) from operations plus (i) amortization of intangible assets, (ii) restructuring charges, (iii) legal fees related to the issued and subsequently withdrawn LCDs, (iv) compensation expenses related to retention for sales employees impacted by the issued and subsequently withdrawn LCDs, (v) impairment of a purchased building and improvements and (vi) write-down of capitalized software costs.

    The following table presents a reconciliation of GAAP income (loss) from operations to non-GAAP operating income, for the periods presented:

      Three Months Ended September 30,  Nine Months Ended September 30, 
      2024  2023  2024  2023 
      (Unaudited, in thousands) 
    Income (loss) from operations $6,242  $8,050  $(11,502) $13,794 
    Amortization of intangible assets  834   1,229   2,569   3,688 
    Restructuring charge (1)  —   95   —   1,878 
    Legal fees (2)  —   1,182   —   1,182 
    Sales retention (3)  —   422   —   422 
    Impairment of building and improvements (4)  —   —   18,842   — 
    Write-down of capitalized software costs (5)  —   —   3,959   — 
    Non-GAAP operating income $7,076  $10,978  $13,868  $20,964 
     
    1. Amount reflects employee severance, retention and benefits as well as other exit costs associated with the Company’s restructuring activities.
    2. Amount represents the legal fees incurred related to the issued and subsequently withdrawn LCDs.
    3. Amount represents the compensation expenses related to retention for those sales employees impacted by the issued and subsequently withdrawn 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 in the development of internal-use software, that the Company determined have no future value.

    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, 2024:

      Year Ended December 31, 
      2024L  2024H 
    Net income (loss) $(12,300) $(600)
    Interest expense, net  3,000   3,000 
    Income tax expense  (8,000)  (4,000)
    Depreciation and amortization  13,000   13,000 
    Amortization of intangible assets  3,000   3,000 
    EBITDA $(1,300) $14,400 
    Stock-based compensation expense  10,000   10,000 
    Impairment of building and improvements  19,000   19,000 
    Write-down of capitalized software costs  4,000   4,000 
    Adjusted EBITDA $31,700  $47,400 


    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, 2024:

      Year Ending December 31,  
      2024L  2024H  
    Net income (loss) $(12,300) $(600) 
    Amortization of intangible assets  3,000   3,000  
    Impairment of building and improvements  19,000   19,000  
    Write-down of capitalized software costs  4,000   4,000  
    Tax on above  (7,000)  (7,000) 
    Adjusted net income $6,700  $18,400  


    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); (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) any resurgence of the COVID-19 pandemic and its impact, if any, on the Company’s fiscal condition and results of operations; (11) 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; (12) whether the Company is able to obtain regulatory approval for and successfully commercialize ReNu; and (13) 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, 2023 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@westwicke.com

Press and Media Inquiries:
Organogenesis
communications@organo.com

    Primary Logo

シェアする