ORGO Organogenesis Holdings (A)

Organogenesis Holdings Inc. Reports First Quarter 2024 Financial Results

Organogenesis Holdings Inc. Reports First Quarter 2024 Financial Results

CANTON, Mass., May 09, 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 first quarter ended March 31st, 2024.

First Quarter 2024 Financial Results Summary:

  • Net revenue of $110.0 million for the first quarter of 2024, an increase of $2.3 million compared to net revenue of $107.6 million for the first quarter of 2023. Net revenue for the first quarter of 2024 consists of:
    • Net revenue from Advanced Wound Care products of $103.9 million, an increase of 3% from the first quarter of 2023.
    • Net revenue from Surgical & Sports Medicine products of $6.1 million, a decrease of 9% from the first quarter of 2023.
  • Net loss of $2.1 million for the first quarter of 2024, compared to a net loss of $3.0 million for the first quarter of 2023, a decrease in net loss of $0.9 million.
  • Adjusted net loss1 of $1.4 million for the first quarter of 2024, compared to an adjusted net loss of $0.7 million for the first quarter of 2023, an increase in adjusted net loss of $0.8 million.
  • Adjusted EBITDA of $2.6 million for the first quarter of 2024, compared to Adjusted EBITDA of $3.8 million for the first quarter of 2023, a decrease of $1.2 million.

"We delivered a strong start to 2024 with first quarter revenue exceeding the high-end of our revenue guidance," said Gary S. Gillheeney, Sr., President and Chief Executive Officer of Organogenesis. “Our commercial team executed well in navigating the challenging operating environment and driving solid momentum in the quarter.”

Mr. Gillheeney, Sr. continued: “As a market leader, I’m confident that the MACs prioritization of demonstrated clinical efficacy will strengthen our competitive position over the long term. Additionally, we continue to achieve milestones in our ReNu program, which we believe will provide clinically meaningful benefits to the millions of patients suffering from knee OA symptoms. I am very pleased with the advancements we have made as a company and extremely optimistic about our expansion opportunities in a significant new addressable market that has the potential to transform Organogenesis and to provide integrated healing solutions that substantially improve outcomes while lowering the overall cost of care.”

First Quarter 2024 Financial Results:

  Three Months Ended March 31,  Change 
  2024  2023  $  % 
  (in thousands, except for percentages) 
Advanced Wound Care $103,864  $100,917  $2,947   3%
Surgical & Sports Medicine  6,112   6,725   (613)  (9%)
Net revenue $109,976  $107,642  $2,334   2%
                 

Net revenue for the first quarter of 2024 was $110.0 million, compared to $107.6 million for the first quarter of 2023, an increase of $2.3 million, or 2%. The increase in net revenue was driven by an increase of $2.9 million, or 3%, in net revenue for Advanced Wound Care products partially offset by a decrease of $0.6 million, or 9%, in net revenue for Surgical & Sports Medicine products.

Gross profit for the first quarter of 2024 was $81.3 million, or 74% of net revenue, compared to $81.0 million, or 75% of net revenue for the first quarter of 2023, an increase of $0.2 million, or less than 1%.

Operating expenses for the first quarter of 2024 were $85.1 million compared to $85.0 million for the first quarter of 2023, an increase of $0.1 million, or less than 1%. R&D expense was $12.8 million for the first quarter of 2024, compared to $11.2 million for the first quarter of 2023, an increase of $1.6 million, or 14%. Selling, general and administrative expenses were $72.3 million for the first quarter of 2024, compared to $73.8 million for the first quarter of 2023, a decrease of $1.5 million, or 2%.

Operating loss for the first quarter of 2024 was $3.9 million, compared to an operating loss of $4.0 million for the first quarter of 2023, a decrease in operating loss of $0.1 million, or 3%.

Total other expense, net, for the first quarter of 2024 was $0.5 million, compared to $0.6 million for the first quarter of 2023, a decrease of $0.1 million, or 22%.

Net loss for the first quarter of 2024 was $2.1 million, or $(0.02) per share, compared to net loss of $3.0 million, or $(0.02) per share, for the first quarter of 2023, a decrease in net loss of $0.9 million, or $0.01 per share.

Adjusted net loss of $1.4 million for the first quarter of 2024, compared to adjusted net loss of $0.7 million for the first quarter of 2023, an increase in adjusted net loss of $0.8 million, or 115%.

Adjusted EBITDA was $2.6 million for the first quarter of 2024, compared to $3.8 million for the first quarter of 2023, a decrease of $1.2 million, or 32%.

As of March 31, 2024, the Company had $89.3 million in cash, cash equivalents and restricted cash and $64.9 million in debt obligations, compared to $104.3 million in cash, cash equivalents and restricted cash and $66.2 million in debt obligations as of December 31, 2023.

Fiscal Year 2024 Guidance:

For the year ending December 31, 2024 the Company is reaffirming its prior guidance for fiscal year 2024 and expects:

  • Net revenue between $445.0 million and $470.0 million, representing 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 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 9% to 27% year-over-year as compared to net revenue of $27.6 million for the year ended December 31, 2023.
  • Net (loss) income between ($10.6) million and $4.6 million and adjusted net (loss) income 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.

First Quarter Earnings Conference Call:

Management will host a conference call at 5:00 p.m. Eastern Time on May 9th 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 or access the teleconference . The live webcast can also be accessed via the company's website at . 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)
 
  March 31,  December 31, 
  2024  2023 
Assets      
Current assets:      
Cash and cash equivalents $88,626  $103,840 
Restricted cash  720   498 
Accounts receivable, net  96,148   81,999 
Inventories, net  27,694   28,253 
Prepaid expenses and other current assets  13,979   10,454 
Total current assets  227,167   225,044 
Property and equipment, net  114,245   116,228 
Intangible assets, net  14,970   15,871 
Goodwill  28,772   28,772 
Operating lease right-of-use assets, net  38,616   40,118 
Deferred tax asset, net  28,002   28,002 
Other assets  6,709   5,990 
Total assets $458,481  $460,025 
Liabilities and Stockholders’ Equity      
Current liabilities:      
Current portion of term loan $5,489  $5,486 
Current portion of finance lease obligations  1,103   1,081 
Current portion of operating lease obligations - related party  8,543   8,413 
Current portion of operating lease obligations  4,675   4,731 
Accounts payable  23,230   30,724 
Accrued expenses and other current liabilities  39,759   30,074 
Total current liabilities  82,799   80,509 
Term loan, net of current portion  59,371   60,745 
Finance lease obligations, net of current portion  1,604   1,888 
Operating lease obligations, net of current portion - related party  11,052   11,954 
Operating lease obligations, net of current portion  24,383   25,053 
Other liabilities  1,242   1,213 
Total liabilities  180,451   181,362 
Commitments and contingencies (Note 14)      
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; 133,267,888 and 132,044,944 shares issued; 132,539,340 and 131,316,396 shares outstanding at March 31, 2024 and December 31, 2023, respectively.  13   13 
Additional paid-in capital  321,088   319,621 
Accumulated deficit  (43,071)  (40,971)
Total stockholders’ equity  278,030   278,663 
Total liabilities and stockholders’ equity $458,481  $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

March 31,
 
  2024  2023 
Net revenue $109,976  $107,642 
Cost of goods sold  28,696   26,607 
Gross profit  81,280   81,035 
Operating expenses:      
Selling, general and administrative  72,322   73,834 
Research and development  12,810   11,202 
Total operating expenses  85,132   85,036 
Loss from operations  (3,852)  (4,001)
Other expense, net:      
Interest expense, net  (514)  (649)
Other income, net  23   23 
Total other expense, net  (491)  (626)
Net loss before income taxes  (4,343)  (4,627)
Income tax benefit  2,243   1,658 
Net loss and comprehensive loss $(2,100) $(2,969)
       
Net loss, per share:      
Basic and diluted $(0.02) $(0.02)
Weighted-average common shares outstanding      
Basic and diluted  131,861,772   131,083,841 



 
ORGANOGENESIS HOLDINGS INC.

UNAUDITED CONSOLIDATED

STATEMENT OF CASH FLOWS


(amounts in thousands, except share and per share data)
 
  Three Months Ended

March 31,
 
  2024  2023 
Cash flows from operating activities:      
Net loss $(2,100) $(2,969)
Adjustments to reconcile net loss to net cash used in operating activities:      
Depreciation  3,072   2,694 
Amortization of intangible assets  901   1,230 
Reduction in the carrying value of right-of-use assets  2,203   1,939 
Non-cash interest expense  105   107 
Deferred interest expense  122   122 
Provision recorded for credit losses  968   243 
Loss on disposal of property and equipment  347   63 
Adjustment for excess and obsolete inventories  2,515   1,407 
Stock-based compensation  2,407   1,914 
Changes in operating assets and liabilities:      
Accounts receivable  (15,117)  (3,429)
Inventories  (4,670)  (2,163)
Prepaid expenses and other current assets and other assets  (4,315)  (4,774)
Operating leases  (2,199)  (2,122)
Accounts payable  (4,391)  (1,390)
Accrued expenses and other current liabilities  9,962   2,029 
Other liabilities  28   22 
Net cash used in operating activities  (10,162)  (5,077)
Cash flows from investing activities:      
Purchases of property and equipment  (2,222)  (7,562)
Net cash used in investing activities  (2,222)  (7,562)
Cash flows from financing activities:      
Payments of term loan under the 2021 Credit Agreement  (1,406)  (938)
Payments of withholding taxes in connection with RSUs vesting  (1,120)  (298)
Proceeds from the exercise of stock options  180   - 
Principal repayments of finance lease obligations  (262)  - 
Net cash used in financing activities  (2,608)  (1,236)
Change in cash, cash equivalents and restricted cash  (14,992)  (13,875)
Cash, cash equivalents, and restricted cash, beginning of period  104,338   103,290 
Cash, cash equivalents, and restricted cash, end of period $89,346  $89,415 
Supplemental disclosure of cash flow information:      
Cash paid for interest $1,375  $1,271 
Cash paid for income taxes $35  $128 
Supplemental disclosure of non-cash investing and financing activities:      
Cumulative effect adjustment for adoption of ASU No. 2016-13 (Note 2) $  $615 
Purchases of property and equipment included in accounts payable and accrued expenses $786  $1,986 
Right-of-use assets obtained through operating lease obligations $701  $1,586 
         

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 (loss) to evaluate our operating performance and trends and make planning decisions. Our management believes Adjusted EBITDA and adjusted net income (loss) 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 (loss) 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 loss to non-GAAP EBITDA and non-GAAP Adjusted EBITDA, for the periods presented:

` Three Months Ended March 31, 
  2024  2023 
  (Unaudited, in thousands) 
Net loss $(2,100) $(2,969)
Interest expense, net  514   649 
Income tax benefit  (2,243)  (1,658)
Depreciation  3,072   2,694 
Amortization  901   1,230 
EBITDA  144   (54)
Stock-based compensation expense  2,407   1,914 
Restructuring charge (1)     1,908 
Adjusted EBITDA $2,551  $3,768 

(1) Amount reflects employee severance, retention and benefits as well as other exit costs associated with the Company’s restructuring activities.



The following table presents a reconciliation of GAAP net loss to non-GAAP adjusted net loss, for the periods presented:

  Three Months Ended March 31, 
  2024  2023 
  (Unaudited, in thousands) 
Net loss $(2,100) $(2,969)
Amortization  901   1,230 
Restructuring charge (1)     1,908 
Tax on above  (243)  (839)
Adjusted net loss $(1,442) $(670)

(1) Amount reflects employee severance, retention and benefits as well as other exit costs associated with the Company’s restructuring activities.

The following table presents a reconciliation of projected GAAP net (loss) income 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 (loss) income $(10,565) $4,616 
Interest expense, net  3,000   2,200 
Income tax expense  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 
Adjusted EBITDA $15,823  $34,957 
         

The following table presents a reconciliation of projected GAAP net (loss) income to projected non-GAAP adjusted net (loss) income included in our guidance for the year ending December 31, 2024:

  Year Ending December 31, 
  2024L  2024H 
Net (loss) income $(10,565) $4,616 
Amortization  3,400   3,400 
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 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 .



Investor Inquiries:
Westwicke Partners
Mike Piccinino, CFA
 
443-213-0500

Press and Media Inquiries:
Organogenesis
 
EN
09/05/2024

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