Canton, MA, February 29, 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 fourth quarter and the year ended December 31, 2023.
“We are building positive momentum with the many commercial support programs implemented to enhance existing customer relationships and regain lost accounts in a uniquely challenging operating environment”, said Gary S. Gillheeney, Sr., President and Chief Executive Officer of Organogenesis. "Despite the expected operating environment challenges, we delivered revenues within the lower end of our guidance. Looking ahead to 2024, we expect to return to revenue growth through continued demonstration of value to our customers and new product launches in both our Advanced Wound Care and Surgical & Sports Medicine markets broadening our portfolio of differentiated treatment options.”
Mr. Gillheeney, Sr. continued: “We continue to make progress with the ReNu program, which we believe, represents a significant value driver by addressing a critical unmet need in treating the symptoms of knee osteoarthritis. We remain confident in the long-term opportunity for Organogenesis and expect to continue to lead in our space with highly innovative products that deliver on our mission to provide integrated healing solutions that substantially improve outcomes while lowering the overall cost of care.”
1 Defined as GAAP net income adjusted to exclude the effect of amortization, restructuring charges, LCD legal fees and sales retention, write-off of certain assets, facility construction project pause, GPO settlement fee and the resulting income taxes on these items.
| Three Month Ended December 31, | Change | |||||||||||||||
| 2023 | 2022 | $ | % | |||||||||||||
| (in thousands, except for percentages) | ||||||||||||||||
| Advanced Wound Care | $ | 93,165 | $ | 108,836 | $ | (15,671 | ) | (14 | %) | |||||||
| Surgical & Sports Medicine | 6,486 | 6,680 | (194 | ) | (3 | %) | ||||||||||
| Net revenue | $ | 99,651 | $ | 115,516 | $ | (15,865 | ) | (14 | %) | |||||||
Net revenue for the fourth quarter of 2023 was $99.7 million, compared to $115.5 million for the fourth quarter of 2022, a decrease of $15.9 million, or 14%. The decrease in net revenue was driven by a decrease of $15.7 million, or 14% in net revenue of Advanced Wound Care products and a decrease of $0.2 million, or 3% in net revenue of Surgical & Sports Medicine products.
Gross profit for the fourth quarter of 2023 was $71.9 million, or 72% of net revenue, compared to $88.4 million or 77% of net revenue, for the fourth quarter of 2022, a decrease of $16.5 million, or 19%.
Operating expenses for the fourth quarter of 2023 were $73.2 million, compared to $79.7 million for the fourth quarter of 2022, a decrease of $6.5 million, or 8%. R&D expenses were $11.8 million for the fourth quarter of 2023, compared to $11.4 million in the fourth quarter of 2022, an increase of $0.4 million, or 3%. Selling, general and administrative expenses were $61.4 million, compared to $68.3 million in the fourth quarter of 2022, a decrease of $6.9 million, or 10%.
Operating loss for the fourth quarter of 2023 was $1.3 million, compared to operating income of $8.7 million for the fourth quarter of 2022, a decrease of $10.0 million.
Total other expense, net, for the fourth quarter of 2023 was $0.5 million, compared to other income, net of less than $0.1 million for the fourth quarter of 2022, a decrease of approximately $0.6 million.
Net loss for the fourth quarter of 2023 was $0.6 million, or $(0.00) per share, compared to net income of $7.5 million, or $0.06 per share, for the fourth quarter of 2022, a decrease of $8.1 million, or $0.06 per share.
Adjusted net income was $1.9 million for the fourth quarter of 2023, compared to adjusted net income of $8.9 million for the fourth quarter of 2022, a decrease of $7.0 million, or 78%.
Adjusted EBITDA was $7.5 million for the fourth quarter of 2023, compared to $14.1 million for the fourth quarter of 2022, a decrease of $6.6 million, or 47%.
As of December 31, 2023, the Company had $104.3 million in cash, cash equivalents and restricted cash and $66.2 million in term loan debt obligations, compared to $103.3 million in cash, cash equivalents and restricted cash and $70.8 million in term loan debt obligations, as of December 31, 2022.
The following table represents net revenue by product grouping for the year ended December 31, 2023 and December 31, 2022, respectively:
| Year Ended December 31, | Change | |||||||||||||||
| 2023 | 2022 | $ | % | |||||||||||||
| (in thousands, except for percentages) | ||||||||||||||||
| Advanced Wound Care | $ | 405,514 | $ | 422,231 | $ | (16,717 | ) | (4 | %) | |||||||
| Surgical & Sports Medicine | 27,626 | 28,662 | (1,036 | ) | (4 | %) | ||||||||||
| Net revenue | $ | 433,140 | $ | 450,893 | $ | (17,753 | ) | (4 | %) | |||||||
Net revenue for the year ended December 31, 2023 was $433.1 million, compared to $450.9 million for the year ended December 31, 2022, a decrease of $17.8 million, or 4%. The decrease in net revenue was driven by a decrease of $16.7 million, or 4% in net revenue of Advanced Wound Care products and a decrease of $1.0 million, or 4% in net revenue of Surgical & Sports Medicine products.
Gross profit for the year ended December 31, 2023 is $326.7 million, or 75% of net revenue, compared to $345.9 million, or 77% of net revenue, for the year ended December 31, 2022, a decrease of $19.2 million, or 6%.
Operating expenses for the year ended December 31, 2023 were $314.1 million, compared to $323.6 million for the year ended December 31, 2022, a decrease of $9.4 million, or 3%. R&D expenses were $44.4 million for the year ended December 31, 2023, compared to $39.8 million for year ended December 31, 2022, an increase of $4.6 million, or 12%. Selling, general and administrative expenses were $269.8 million for year ended December 31, 2023, compared to $283.8 million year ended December 31, 2022, a decrease of $14.1 million, or 5%.
Operating income for the year ended December 31, 2023 was $12.5 million, compared to an operating income of $22.3 million for the year ended December 31, 2022, a decrease of $9.8 million.
Total other expense, net, for the year ended December 31, 2023 was $2.1 million, compared to $2.0 million for the year ended December 31, 2022, a decrease of $0.1 million.
Net income of $4.9 million for the year ended December 31, 2023 or $0.04 per share, compared to net income of $15.5 million, or $0.12 per share for the year ended December 31, 2022, a decrease of $10.5 million, or $0.08 per share.
Adjusted net income for the year ended December 31, 2023 was $12.7 million., compared to $26.2 million for the year ended December 31, 2022, a decrease of $13.5 million, or 52%.
Adjusted EBITDA of $42.6 million for the year ended December 31, 2023, compared to Adjusted EBITDA of $49.3 million for the year ended December 31, 2022, a decrease of $6.7 million, or 14%.
For the year ending December 31, 2024, the Company expects:
Financial results for the fourth fiscal quarter and year ended December 31, 2023 will be reported after the market closes on Thursday, February 29th. Management will host a conference call at 5:00 p.m. Eastern Time on February 29th to discuss the results of the quarter, and 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. A live webcast of the call will also be provided on the investor relations section of the Company's website at investors.organogenesis.com.
For those unable to participate, the webcast will be archived at investors.organogenesis.com for approximately one year.
ORGANOGENESIS HOLDINGS INC.
UNAUDITED CONSOLIDATED BALANCE SHEETS
(amounts in thousands, except share and per share data)
| December 31, | ||||||||
| 2023 | 2022 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 103,840 | $ | 102,478 | ||||
| Restricted cash | 498 | 812 | ||||||
| Accounts receivable, net | 81,999 | 89,450 | ||||||
| Inventories | 28,253 | 24,783 | ||||||
| Prepaid expenses and other current assets | 10,454 | 5,086 | ||||||
| Total current assets | 225,044 | 222,609 | ||||||
| Property and equipment, net | 116,228 | 102,463 | ||||||
| Intangible assets, net | 15,871 | 20,789 | ||||||
| Goodwill | 28,772 | 28,772 | ||||||
| Operating lease right-of-use assets, net | 40,118 | 43,192 | ||||||
| Deferred tax asset, net | 28,002 | 30,014 | ||||||
| Other assets | 5,990 | 1,520 | ||||||
| Total assets | $ | 460,025 | $ | 449,359 | ||||
| Liabilities and Stockholders' Equity | ||||||||
| Current liabilities: | ||||||||
| Current portion of term loan | $ | 5,486 | $ | 4,538 | ||||
| Current portion of finance lease obligations | 1,081 | — | ||||||
| Current portion of operating lease obligations - related party | 3,140 | 3,001 | ||||||
| Current portion of operating lease obligations | 10,004 | 8,707 | ||||||
| Accounts payable | 30,724 | 32,330 | ||||||
| Accrued expenses and other current liabilities | 30,074 | 26,447 | ||||||
| Total current liabilities | 80,509 | 75,023 | ||||||
| Term loan, net of current portion | 60,745 | 66,231 | ||||||
| Finance lease obligations, net of current portion | 1,888 | — | ||||||
| Operating lease obligations, net of current portion - related party | 17,227 | 20,367 | ||||||
| Operating lease obligations, net of current portion | 19,780 | 20,947 | ||||||
| Other liabilities | 1,213 | 1,122 | ||||||
| Total liabilities | 181,362 | 183,690 | ||||||
| Commitments and contingencies (Note 18) | ||||||||
| 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; 132,044,944 and 131,647,677 shares issued; 131,316,396 and 130,919,129 shares outstanding at December 31, 2023 and 2022, respectively. | 13 | 13 | ||||||
| Additional paid-in capital | 319,621 | 310,957 | ||||||
| Accumulated deficit | (40,971 | ) | (45,301 | ) | ||||
| Total stockholders' equity | 278,663 | 265,669 | ||||||
| Total liabilities and stockholders' equity | $ | 460,025 | $ | 449,359 | ||||
ORGANOGENESIS HOLDINGS INC.
UNAUDITED CONSOLIDATED
STATEMENTS OF OPERATIONS AND
COMPREHENSIVE INCOME
(amounts in thousands, except share and per share data)
| Three Months Ended December 31, | Year Ended December 31, | |||||||||||||||
| 2023 | 2022 | 2023 | 2022 | |||||||||||||
| Net revenue | $ | 99,651 | $ | 115,516 | $ | 433,140 | $ | 450,893 | ||||||||
| Cost of goods sold | 27,769 | 27,110 | 106,481 | 105,019 | ||||||||||||
| Gross profit | 71,882 | 88,406 | 326,659 | 345,874 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Selling, general and administrative | 61,381 | 68,293 | 269,754 | 283,808 | ||||||||||||
| Research and development | 11,770 | 11,395 | 44,380 | 39,762 | ||||||||||||
| Total operating expenses | 73,151 | 79,688 | 314,134 | 323,570 | ||||||||||||
| Loss (income) from operations | (1,269 | ) | 8,718 | 12,525 | 22,304 | |||||||||||
| Other expense, net: | ||||||||||||||||
| Interest expense, net | (502 | ) | 30 | (2,190 | ) | (2,009 | ) | |||||||||
| Other income (expense), net | (25 | ) | 6 | 57 | (13 | ) | ||||||||||
| Total other expense, net | (527 | ) | 36 | (2,133 | ) | (2,022 | ) | |||||||||
| Net income before income taxes | (1,796 | ) | 8,754 | 10,392 | 20,282 | |||||||||||
| Income tax (expense) benefit | 1,228 | (1,268 | ) | (5,447 | ) | (4,750 | ) | |||||||||
| Net (loss) income and comprehensive (loss) income | $ | (568 | ) | $ | 7,486 | $ | 4,945 | $ | 15,532 | |||||||
| Net income, per share: | ||||||||||||||||
| Basic | $ | (0.00 | ) | $ | 0.06 | $ | 0.04 | $ | 0.12 | |||||||
| Diluted | $ | (0.00 | ) | $ | 0.06 | $ | 0.04 | $ | 0.12 | |||||||
| Weighted-average common shares outstanding | ||||||||||||||||
| Basic | 130,916,950 | 128,661,435 | 131,231,317 | 130,070,231 | ||||||||||||
| Diluted | 131,857,509 | 133,348,995 | 132,746,727 | 132,383,152 | ||||||||||||
ORGANOGENESIS HOLDINGS INC.
UNAUDITED CONSOLIDATED
STATEMENT OF CASH FLOWS
(amounts in thousands, except share and per share data)
| Year Ended December 31, | ||||||||||||
| 2023 | 2022 | 2021 | ||||||||||
| Cash flows from operating activities: | ||||||||||||
| Net income | $ | 4,945 | $ | 15,532 | $ | 94,202 | ||||||
| Adjustments to reconcile net income to net cash provided by operating activities: | ||||||||||||
| Depreciation | 10,448 | 5,845 | 5,781 | |||||||||
| Amortization of intangible assets | 4,918 | 4,883 | 4,949 | |||||||||
| Amortization of operating lease right-of-use assets | 8,083 | 7,303 | 5,946 | |||||||||
| Non-cash interest expense | 427 | 434 | 346 | |||||||||
| Deferred interest expense | 490 | 501 | 1,493 | |||||||||
| Deferred tax expense (benefit) | 2,012 | 1,980 | (31,976 | ) | ||||||||
| Loss on disposal of property and equipment | 235 | 4,482 | 1,407 | |||||||||
| Loss on lease termination | 559 | — | — | |||||||||
| Provision recorded for credit losses | 1,297 | 1,781 | 2,999 | |||||||||
| Adjustment for excess and obsolete inventories | 6,580 | 9,648 | 12,079 | |||||||||
| Stock-based compensation | 8,996 | 6,552 | 3,864 | |||||||||
| Loss on extinguishment of debt | — | — | 1,883 | |||||||||
| Change in fair value of earnout liability | — | — | (3,985 | ) | ||||||||
| Changes in operating assets and liabilities: | ||||||||||||
| Accounts receivable | 5,539 | (8,770 | ) | (28,654 | ) | |||||||
| Inventories | (8,179 | ) | (9,410 | ) | (9,302 | ) | ||||||
| Prepaid expenses and other current and other assets | (10,115 | ) | (378 | ) | (34 | ) | ||||||
| Operating leases | (8,439 | ) | (7,006 | ) | (6,156 | ) | ||||||
| Accounts payable | (108 | ) | 3,260 | 3,847 | ||||||||
| Accrued expenses and other current liabilities | 3,138 | (11,850 | ) | 9,354 | ||||||||
| Other liabilities | 91 | 72 | (6,065 | ) | ||||||||
| Net cash provided by operating activities | 30,917 | 24,859 | 61,978 | |||||||||
| Cash flows from investing activities: | ||||||||||||
| Purchases of property and equipment | (24,364 | ) | (33,898 | ) | (31,220 | ) | ||||||
| Net cash used in investing activities | (24,364 | ) | (33,898 | ) | (31,220 | ) | ||||||
| Cash flows from financing activities: | ||||||||||||
| Line of credit repayments under the 2019 Credit Agreement | — | — | (10,000 | ) | ||||||||
| Term loan repayments under the 2019 Credit Agreement | — | — | (60,000 | ) | ||||||||
| Proceeds from term loan under the 2021 Credit Agreement, net of debt discount and issuance cost | — | — | 73,174 | |||||||||
| Term loan repayments under the 2021 Credit Agreement | (4,688 | ) | (2,813 | ) | (938 | ) | ||||||
| Principal repayments of finance lease obligations | (485 | ) | (200 | ) | (2,630 | ) | ||||||
| Proceeds from the exercise of stock options | — | 2,070 | 2,198 | |||||||||
| Payments of withholding taxes in connection with RSUs vesting | (332 | ) | (648 | ) | (737 | ) | ||||||
| Payments of deferred acquisition consideration | — | (608 | ) | (483 | ) | |||||||
| Payment to extinguish debt | — | — | (1,620 | ) | ||||||||
| Net cash used in financing activities | (5,505 | ) | (2,199 | ) | (1,036 | ) | ||||||
| Change in cash, cash equivalents and restricted cash | 1,048 | (11,238 | ) | 29,722 | ||||||||
| Cash, cash equivalents, and restricted cash, beginning of year | 103,290 | 114,528 | 84,806 | |||||||||
| Cash, cash equivalents, and restricted cash, end of year | $ | 104,338 | $ | 103,290 | $ | 114,528 | ||||||
| Supplemental disclosure of cash flow information: | ||||||||||||
| Cash paid for interest | $ | 5,436 | $ | 2,649 | $ | 5,787 | ||||||
| Cash paid for income taxes | $ | 3,052 | $ | 1,201 | $ | 607 | ||||||
| Supplemental disclosure of non-cash investing and financing activities: | ||||||||||||
| Cumulative effect adjustment for adoption of ASU No. 2016-13 (Note 2) | $ | 615 | $ | — | $ | — | ||||||
| Deferred acquisition consideration and earnout liability recorded for business acquisition | $ | — | $ | 828 | $ | — | ||||||
| Purchases of property and equipment in accounts payable and accrued expenses | $ | 841 | $ | 1,928 | $ | 3,750 | ||||||
| Right-of-use assets obtained through operating lease obligations | $ | 5,869 | $ | 1,350 | $ | 53,793 | ||||||
| Right-of-use assets obtained through finance lease obligations | $ | 3,454 | $ | — | $ | — | ||||||
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.
The following table presents a reconciliation of GAAP net income to non-GAAP EBITDA and non-GAAP Adjusted EBITDA, for each of the periods presented:
| Three Months Ended December 31, | Year Ended December 31, | |||||||||||||||
| ($, in thousands) | 2023 | 2022 | 2023 | 2022 | ||||||||||||
| Net (loss) income | $ | (568 | ) | $ | 7,486 | $ | 4,945 | $ | 15,532 | |||||||
| Interest expense, net | 502 | (30 | ) | 2,190 | 2,009 | |||||||||||
| Income tax expense (benefit) | (1,228 | ) | 1,268 | 5,447 | 4,750 | |||||||||||
| Depreciation | 2,982 | 1,514 | 10,448 | 5,845 | ||||||||||||
| Amortization | 1,229 | 1,221 | 4,918 | 4,883 | ||||||||||||
| EBITDA | 2,917 | 11,459 | 27,948 | 33,019 | ||||||||||||
| Stock-based compensation expense | 2,366 | 1,855 | 8,996 | 6,552 | ||||||||||||
| Restructuring charge (1) | 1,918 | 750 | 3,796 | 2,268 | ||||||||||||
| Write-off of certain assets (2) | — | — | — | 4,200 | ||||||||||||
| Settlement fee (3) | — | — | — | 2,600 | ||||||||||||
| Facility construction project pause (4) | — | — | — | 632 | ||||||||||||
| Legal fees (5) | — | — | 1,182 | — | ||||||||||||
| Sales retention (6) | 272 | — | 694 | — | ||||||||||||
| Adjusted EBITDA | $ | 7,473 | $ | 14,064 | $ | 42,616 | $ | 49,271 | ||||||||
(1) Amounts reflect employee retention and benefits as well as other exit costs associated with the Company's restructuring activities.
(2) Amount reflects the disposal of certain equipment related to the same facility.
(3) Amounts reflect the fee the Company paid to a GPO to settle previously disputed GPO fees.
(4) Amount reflects the cancellation fees incurred in connection with the Company's decision to pause one of its manufacturing facility construction projects.
(5) Amount represents the legal fees incurred related to the recently published and withdrawn local coverage determinations, or LCDs.
(6) Amount represents the compensation expenses related to retention for those sales employees impacted by the LCDs.
The following table presents a reconciliation of GAAP net income to non-GAAP adjusted net income, for each of the periods presented:
| Three Months Ended December 31, | Year Ended December 31, | |||||||||||||||
| ($, in thousands) | 2023 | 2022 | 2023 | 2022 | ||||||||||||
| Net (loss) income | $ | (568 | ) | $ | 7,486 | $ | 4,945 | $ | 15,532 | |||||||
| Amortization | 1,229 | 1,221 | 4,918 | 4,883 | ||||||||||||
| Restructuring charge (1) | 1,918 | 750 | 3,796 | 2,268 | ||||||||||||
| Write-off of certain assets (2) | — | — | — | 4,200 | ||||||||||||
| Settlement fee (3) | — | — | — | 2,600 | ||||||||||||
| Facility construction project pause (4) | — | — | — | 632 | ||||||||||||
| Legal fees (5) | — | — | 1,182 | — | ||||||||||||
| Sales retention (6) | 272 | — | 694 | — | ||||||||||||
| Tax on above | (923 | ) | (527 | ) | (2,859 | ) | (3,898 | ) | ||||||||
| Adjusted net income | $ | 1,928 | $ | 8,930 | $ | 12,676 | $ | 26,217 | ||||||||
(1) Amounts reflect employee retention and benefits as well as other exit costs associated with the Company's restructuring activities.
(2) Amount reflects the disposal of certain equipment related to the same facility.
(3) Amounts reflect the fee the Company paid to a GPO to settle previously disputed GPO fees.
(4) Amount reflects the cancellation fees incurred in connection with the Company's decision to pause one of its manufacturing facility construction projects.
(5) Amount represents the legal fees incurred related to the recently published and withdrawn local coverage determinations, or LCDs.
(6) Amount represents the compensation expenses related to retention for those sales employees impacted by the LCDs.
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, | ||||||||
| ($, in thousands) | 2024L | 2024H | ||||||
| Net (loss) income | $ | (10,565 | ) | $ | 4,616 | |||
| Interest expense, net | 3,000 | 2,200 | ||||||
| Income tax expense (benefit) | 308 | 5,061 | ||||||
| Depreciation | 9,680 | 9,680 | ||||||
| Amortization | 3,400 | 3,400 | ||||||
| EBITDA | 5,823 | 24,957 | ||||||
| Stock-based compensation expense | 10,000 | 10,000 | ||||||
| Restructuring charge | - | - | ||||||
| Adjusted EBITDA | 15,823 | 34,957 | ||||||
The following table presents a reconciliation of projected GAAP net income (loss) to projected non-GAAP adjusted net income included in our guidance for the year ending December 31, 2024:
| Year Ended December 31, | ||||||||
| ($, in thousands) | 2024L | 2024H | ||||||
| Net (loss) income | $ | (10,565 | ) | $ | 4,616 | |||
| Amortization | 3,400 | 3,400 | ||||||
| Restructuring charge | — | — | ||||||
| Tax on above | (918 | ) | (918 | ) | ||||
| Adjusted net (loss) income | $ | (8,083 | ) | $ | 7,098 | |||
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, 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 reimbursement levels for the Company's products; (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 prior years 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; 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, 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.
Organogenesis Holdings Inc. is a leading regenerative medicine company offering a portfolio of bioactive and acellular biomaterials products in advanced wound care and surgical biologics, including orthopedics and spine. Organogenesis's comprehensive portfolio is designed to treat a variety of patients with repair and regenerative needs. For more information, visit www.organogenesis.com.
Investor Inquiries:
ICR Westwicke
Mike Piccinino, CFA
OrganoIR@westwicke.com
Press and Media Inquiries:
Organogenesis
Lori Freedman
LFreedman@organo.com