Organogenesis Holdings Inc.
For the period ended Sep 30, 2026. Filed Nov 5, 2026.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2026 · Filed Nov 5, 2026
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Item 1A. Risk Factors
Investing in our Class A common stock involves a high degree of risk. Our Annual Report on Form 10-K for the year ended December 31, 2025, includes a detailed discussion of our risk factors under the heading “Part I, Item 1A—Risk Factors.” Other than the risk factor set forth below, there have been no material changes from such risk factors during the quarter ended September 30, 2026. You should consider carefully the risk factor set forth below, the risk factors discussed in our Annual Report on Form 10-K for the year ended December 31, 2025, and all other information contained in or incorporated by reference in this Form 10-Q before making an investment decision. If any of the risks discussed in the Annual Report on Form 10-K for the year ended December 31, 2025, or herein actually occur, they may materially harm our business, financial condition, operating results, cash flows or growth prospects. As a result, the market price of our Class A common stock could decline, and you could lose all or part of your investment. Additional risks and uncertainties that are not yet identified or that we think are immaterial may also materially harm our business, financial condition, operating results, cash flows or growth prospects and could result in a complete loss of your investment.
Our future capital needs are uncertain and we may need to raise funds in the future, and such funds may not be available on acceptable terms or at all.
Our cash balance has been declining in 2026 due to reduced product revenue. We may seek to raise cash from stock offerings, including sales under the ATM Agreement, borrowings under future credit facilities or other sources. Our Revolving Facility expired on August 6, 2026, and our net product revenue for the nine months ended September 30, 2026 decreased materially compared to the prior-year period, primarily as a result of market disruption following the withdrawal of the LCD coverage policies for skin substitutes and CMS published comments regarding discarded product in December 2025. Our capital requirements will depend on many factors, including:
the costs associated with our sales and marketing efforts;
the expenses we incur in manufacturing and selling our products;
the costs of developing and commercializing new products or technologies;
the cost of obtaining and maintaining regulatory approval or clearance of certain products and products in development;
the number and timing of acquisitions and other strategic transactions such as our acquisitions of NuTech Medical and CPN Biosciences, and integration costs associated with such acquisitions;
the costs associated with capital expenditures; and
unanticipated general, legal, and administrative expenses.
We cannot assure you that the ATM Agreement will provide us with meaningful liquidity. Although a substantial portion of the $75.0 million aggregate sales value remained available as of September 30, 2026, the ATM Agreement is not a committed financing facility, and our ability to sell shares under it depends on market conditions, the trading price and trading volume of our Class A common stock, limitations imposed by applicable securities laws and our registration statement and the satisfaction of other conditions. As a result, we may be unable to raise any specific amount, or any amount, under the ATM Agreement when we need capital, and any sales we do make would dilute our existing stockholders.
Our operating plan may change as a result of many factors currently unknown to us and we may need additional funds sooner than planned. Additional funds may not be available when we need them on terms that are acceptable to us, or at all, and our recent operating results, the decline in the trading price of our Class A common stock and the expiration of our Revolving Facility may make additional financing more difficult or more costly to obtain. Furthermore, if we issue equity or convertible debt securities to raise capital, you may experience dilution, and the new equity or convertible debt securities may have rights, preferences, and privileges that are senior to or otherwise adversely affect your rights as a stockholder. In addition, if we raise capital through collaboration, licensing or other similar arrangements, it may be necessary to relinquish valuable rights to our products, potential products or proprietary technologies, or grant licenses on terms that are not favorable to us. If we cannot raise capital on acceptable terms, we may not be able to develop our product candidates, enhance our existing products, execute our business plan, take advantage of future opportunities, or respond to competitive pressure, changes in our supplier relationships, or unanticipated customer requirements. Any of these events could adversely affect our ability to achieve our development and commercialization goals, which could have a material adverse effect on our business, results of operations, and financial condition.
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