Organogenesis Holdings Inc. Reports Fourth Quarter 2023 and Fiscal Year 2023 Financial Results; Introduces Fiscal Year 2024 Guidance

2024-02-29

财报

CANTON, Mass., Feb. 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.

Fourth Quarter 2023 Financial Results Summary:

Net revenue of $99.7 million for the fourth quarter of 2023, a decrease of 14% compared to net revenue of $115.5 million for the fourth quarter of 2022. Net revenue for the fourth quarter of 2023 consists of: Net revenue from Advanced Wound Care products of $93.2 million, a decrease of 14% from the fourth quarter of 2022.

Net revenue from Surgical & Sports Medicine products of $6.5 million, a decrease of 3% from the fourth quarter of 2022.

Net loss of $0.6 million for the fourth quarter of 2023, compared to net income of $7.5 million for the fourth quarter of 2022, a decrease of $8.1 million.

Adjusted net income1 of $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.

Adjusted EBITDA of $7.5 million for the fourth quarter of 2023, compared to Adjusted EBITDA of $14.1 million for the fourth quarter of 2022, a decrease of $6.6 million.

Fiscal Year 2023 Financial Results Summary:

Net revenue of $433.1 million for the year ended December 31, 2023, a decrease of 4% compared to net revenue of $450.9 million for the year ended December 31, 2022. Net revenue for the year ended December 31, 2023 consists of: Net revenue from Advanced Wound Care products of $405.5 million, a decrease of 4% year-over-year.

Net revenue from Surgical & Sports Medicine products of $27.6 million, a decrease of 4% year-over-year.

Net income of $4.9 million for the year ended December 31, 2023, compared to net income of $15.5 million for the year ended December 31, 2022, a decrease of $10.5 million.

Adjusted net income1 of $12.7 million for the year ended December 31, 2023, compared to an adjusted net income of $26.2 million for the year ended December 31, 2022, a decrease of $13.5 million.

Adjusted EBITDA of $42.6 million for the year ended December 31, 2023, compared to an adjusted EBITDA of $49.3 million for the year ended December 31, 2022, a decrease of $6.7 million.

“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.”

1Defined 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.

Fourth Quarter 2023 Financial Results:

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.

Fiscal Year 2023 Results

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%.

Fiscal Year 2024 Guidance:

For the year ending December 31, 2024, the Company expects:

Net revenue between $445.0 million and $470.0 million, an increase of approximately 3% to 9% 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 $415.0 million and $435.0 million, an increase of approximately 2% to 7% 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 $30.0 million and $35.0 million, an increase of approximately 9% to 27% year-over-year as compared to net revenue of $27.6 million for the year ended December 31, 2023.

Net income (loss) between ($10.6) million and $4.6 million and adjusted net income (loss) between ($8.1) million and $7.1 million.

EBITDA between $5.8 million and $25.0 million and Adjusted EBITDA between $15.8 million and $35.0 million.

Earnings Conference Call:

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 $— $—

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.

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

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, 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.

About Organogenesis Holdings Inc.

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.