Core Viewpoint - The article does not provide any specific insights or analysis related to a company or industry, focusing instead on the author's qualifications and disclosures [1][2][3]. Group 1 - The author holds multiple degrees in engineering, computer science, business management, and computer applications from various institutions [1]. - The author collaborates with another professional but emphasizes independent analysis and adherence to guidelines [1]. - There is a clear statement of no current stock or derivative positions in any mentioned companies, indicating a lack of conflict of interest [2]. Group 2 - The article includes disclaimers about past performance not guaranteeing future results and clarifies that no investment advice is being provided [3]. - It highlights that the views expressed may not reflect those of the platform as a whole, indicating a diversity of opinions among contributors [3]. - The article notes that the analysts may not be licensed or certified, which could impact the credibility of the analysis [3].

Company Performance - Organogenesis reported a quarterly loss of $0.13 per share, missing the Zacks Consensus Estimate of $0.04, and compared to a loss of $0.02 per share a year ago, representing an earnings surprise of -425% [1] - The company posted revenues of $86.69 million for the quarter ended March 2025, missing the Zacks Consensus Estimate by 4.06%, and down from $109.98 million year-over-year [2] - Over the last four quarters, Organogenesis has surpassed consensus EPS estimates two times and topped consensus revenue estimates three times [2] Stock Performance - Organogenesis shares have increased approximately 61.9% since the beginning of the year, contrasting with the S&P 500's decline of -4.3% [3] - The current consensus EPS estimate for the upcoming quarter is $0.04 on revenues of $143.96 million, and for the current fiscal year, it is $0.16 on revenues of $508.6 million [7] Industry Outlook - The Medical - Drugs industry, to which Organogenesis belongs, is currently ranked in the top 26% of over 250 Zacks industries, indicating a favorable outlook [8] - Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions, suggesting that industry performance can significantly impact stock performance [5][8]

Financial Data and Key Metrics Changes - Net revenue for Q1 2025 was $86.7 million, down 21% year-over-year [16] - Advanced Wound Care net revenue was $79.9 million, down 23% [17] - Surgical and Sports Medicine products net revenue was $6.8 million, up 11% [17] - Gross profit was $63 million, or 72.6% of net revenue, compared to 73.9% last year [17] - Operating loss for Q1 was $26.7 million, compared to an operating loss of $3.9 million last year [17] - GAAP net loss for Q1 was $18.8 million, compared to a net loss of $2.1 million last year [18] - Adjusted EBITDA loss for Q1 was $12.5 million, compared to adjusted EBITDA of $2.6 million last year [19] Business Line Data and Key Metrics Changes - Advanced Wound Care products experienced a significant decline in revenue, while Surgical and Sports Medicine products showed growth [17] - The company faced challenges due to the delayed implementation of the LCD, impacting customer demand and ordering patterns [5][6] Market Data and Key Metrics Changes - The market environment remains uncertain due to the delayed LCD, which has affected customer behavior and buying patterns [5][6] - The company is optimistic about the long-term opportunity as changes in coverage policies are expected to be implemented in 2026, potentially increasing patient access [10] Company Strategy and Development Direction - The company is focused on gathering robust clinical and real-world evidence to support its product portfolio and drive market penetration [11] - The RENEW program is on track, with expectations for a BLA submission by the end of 2025, targeting a large pain management market [12] - The company is expanding its manufacturing capabilities with a new biomanufacturing facility, which will support the introduction of new products [15] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to navigate the challenging market and reaffirmed financial guidance for 2025 [9][19] - The company anticipates a stabilization of market dynamics in the second half of 2025, despite ongoing uncertainties [26][58] Other Important Information - The company has $110.5 million in cash and cash equivalents as of March 31, 2025, with no outstanding debt [19] - The 2025 revenue guidance remains between $480 million and $535 million, with expectations for a gradual improvement in business trends [20] Q&A Session Summary Question: Inquiry about the cadence throughout the year and guidance confidence - Management expressed confidence in the guidance, highlighting optionality in the portfolio and the availability of PuraPly across all indications [24][25] Question: Clarification on gross margin expectations - Management indicated that gross margins are expected to improve in the second half of the year due to a mix shift in the product portfolio and reduced expirations [28][30] Question: Comparison of Q1 performance to Q4 and market dynamics - Management noted that confusion regarding the LCD led to a contraction in the market, which was not present in Q4 [36][37] Question: Future changes in the LCD and CMS involvement - Management believes that CMS is reviewing coverage policies and that the delay allows for more data collection, which could positively impact product approvals [41][42] Question: Guidance reiteration despite LCD delays - Management explained that the broader product portfolio and higher-margin products provide flexibility to maintain guidance despite the LCD delay [50][54]

Financial Data and Key Metrics Changes - The company reported net revenue for Q1 2025 of $86.7 million, a decrease of 21% year-over-year [15] - Advanced Wound Care net revenue was $79.9 million, down 23%, while Surgical and Sports Medicine products revenue increased by 11% to $6.8 million [16] - Gross profit for Q1 was $63 million, representing 72.6% of net revenue, compared to 73.9% in the previous year [16] - Operating loss for Q1 was $26.7 million, significantly higher than the operating loss of $3.9 million in the prior year [17] - GAAP net loss for Q1 was $18.8 million, compared to a net loss of $2.1 million last year [17] - Adjusted EBITDA loss for Q1 was $12.5 million, compared to adjusted EBITDA of $2.6 million in the previous year [18] Business Line Data and Key Metrics Changes - Advanced Wound Care experienced a revenue decline of 23%, while Surgical and Sports Medicine products saw an increase of 11% [16] - The company expects net revenue from Advanced Wound Care products for 2025 to be between $450 million and $500 million, indicating a year-over-year change of a decline of 1% to an increase of 10% [19] - Surgical and Sports Medicine products are projected to generate revenue between $30 million and $35 million, representing a year-over-year increase of 6% to 23% [19] Market Data and Key Metrics Changes - The company noted disruptions in customer demand and ordering patterns due to uncertainty surrounding the effective date of the final LCD for skin substitute grafts [5] - The delay in the LCD implementation until January 1, 2026, is expected to provide an opportunity for the company to serve more patients and positively impact the wound care market [10] Company Strategy and Development Direction - The company is focused on gathering robust clinical and real-world evidence to enhance its product portfolio and market penetration [11] - The RENEW program is on track, with expectations to complete the second Phase III study by the end of Q2 2025 and submit a BLA by the end of the year [12] - The company is expanding its manufacturing capabilities with a new biomanufacturing facility in Smithfield, Rhode Island, which will support the reintroduction of key products [14] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the long-term opportunities for the company, particularly with the expected changes in coverage policies in 2026 [10] - The company anticipates a challenging environment in the first half of 2025, followed by significant improvement in business trends starting in Q3 [19] - Management emphasized the importance of educating customers to stabilize buying behaviors and return to previous purchasing patterns [53] Other Important Information - The company reaffirmed its financial guidance for 2025, expecting net revenue between $480 million and $535 million, with a year-over-year change of roughly flat to an increase of 11% [19] - The company has $110.5 million in cash and cash equivalents as of March 31, 2025, with no outstanding debt obligations [18] Q&A Session Summary Question: Inquiry about the cadence throughout the year and guidance confidence - Management expressed confidence in the guidance, highlighting the optionality in the portfolio and the execution capabilities despite market uncertainties [22][23] Question: Clarification on gross margin expectations - Management indicated that gross margins should improve in the second half of the year due to a mix shift in the product portfolio and reduced expiries [26][27] Question: Comparison of Q1 performance to Q4 and market dynamics - Management noted that confusion regarding the LCD led to a contraction in the market, which was not present in Q4 [34] Question: Discussion on the delay of the LCD and its implications - Management explained that the delay allows for more data collection and could expand the number of products eligible for coverage, which is seen as positive [40][41] Question: Further clarification on guidance and expected inflection points - Management reiterated that the full portfolio is now available, which supports revenue stabilization and growth despite the LCD delay [48][49]

[PART I. FINANCIAL INFORMATION](index=4&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Unaudited Condensed Consolidated Financial Statements](index=4&type=section&id=Item%201.%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) The company reported a significant Q1 2025 net revenue decrease and increased net loss, with total assets declining and a notable asset write-down [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of March 31, 2025, total assets decreased to **$467.4 million**, driven by reduced cash, while liabilities and equity also declined Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $109,965 | $135,571 | | Accounts receivable, net | $103,320 | $109,861 | | Asset held for sale | $7,033 | $— | | Total current assets | $268,160 | $285,941 | | Total assets | $467,394 | $497,886 | | **Liabilities & Equity** | | | | Total current liabilities | $65,053 | $77,477 | | Total liabilities | $99,325 | $112,570 | | Total stockholders' equity | $242,902 | $262,897 | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Net revenue decreased **21.2%** to **$86.7 million** in Q1 2025, leading to a significantly increased operating loss and net loss per share Q1 2025 vs Q1 2024 Statement of Operations (in thousands, except per share data) | Metric | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Net revenue | $86,693 | $109,976 | | Gross profit | $62,970 | $81,280 | | Total operating expenses | $89,716 | $85,132 | | Loss from operations | $(26,746) | $(3,852) | | Net loss | $(18,843) | $(2,100) | | Net loss per share (basic and diluted) | $(0.17) | $(0.02) | - A write-down of **$6,567 thousand** for an asset held for sale was a significant operating expense in Q1 2025, contributing to the increased operating loss[14](index=14&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities significantly increased to **$19.9 million** in Q1 2025, alongside increased cash usage in investing and financing activities Cash Flow Summary (in thousands) | Activity | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(19,935) | $(10,162) | | Net cash used in investing activities | $(3,626) | $(2,222) | | Net cash used in financing activities | $(2,056) | $(2,608) | | **Change in cash, cash equivalents and restricted cash** | **$(25,617)** | **$(14,992)** | [Notes to Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) The notes detail key accounting policies, including a significant decline in Advanced Wound Care revenue, an asset write-down, PSU introduction, and no outstanding debt Revenue by Product Category (in thousands) | Product Category | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Advanced Wound Care | $79,927 | $103,864 | | Surgical & Sports Medicine | $6,766 | $6,112 | | **Total net revenue** | **$86,693** | **$109,976** | - In Q1 2025, the company listed a property for sale and recognized a **$6,567 thousand** write-down to adjust its carrying value to estimated fair market value[43](index=43&type=chunk) - The company introduced Performance Share Units (PSUs) in Q1 2025, granting **602,727 units** to executives, which vest based on performance goals[65](index=65&type=chunk)[66](index=66&type=chunk) - As of March 31, 2025, the company had no outstanding borrowings under its Term Loan Facility or its **$125 million** Revolving Facility[55](index=55&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=22&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management attributes the **21%** revenue decline to customer disruption from delayed Medicare LCDs, leading to increased net loss despite stable liquidity - The implementation of new Local Coverage Determinations (LCDs) by Medicare Administrative Contractors (MACs) has been delayed to **January 1, 2026**. If implemented as finalized, these LCDs would render several of the company's products, including PuraPly and Novachor, non-covered for DFU and VLU indications, which could materially impact revenue[95](index=95&type=chunk)[96](index=96&type=chunk) - Manufacturing of Dermagraft remains suspended, with plans to transition to a new facility in Smithfield, Rhode Island, expected to begin in **2027**. Delays could adversely affect future revenue[94](index=94&type=chunk) Reconciliation of Net Loss to Adjusted EBITDA (Non-GAAP, in thousands) | Metric | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Net loss | $(18,843) | $(2,100) | | EBITDA | $(22,458) | $144 | | Stock-based compensation expense | $3,367 | $2,407 | | Write-down for asset held for sale | $6,567 | $— | | **Adjusted EBITDA** | **$(12,524)** | **$2,551** | [Results of Operations](index=27&type=section&id=MD%26A_Results_of_Operations) Net revenue declined **21%** in Q1 2025, primarily due to a **23%** drop in Advanced Wound Care, while R&D expenses decreased and SG&A remained flat Revenue Comparison: Q1 2025 vs Q1 2024 (in thousands) | Category | Q1 2025 | Q1 2024 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Advanced Wound Care | $79,927 | $103,864 | $(23,937) | (23%) | | Surgical & Sports Medicine | $6,766 | $6,112 | $654 | 11% | | **Net revenue** | **$86,693** | **$109,976** | **$(23,283)** | **(21%)** | - The decrease in Advanced Wound Care revenue was primarily attributed to increased ambiguity and disruption in customer behavior following the delayed implementation of the LCDs[115](index=115&type=chunk) - R&D expenses decreased by **$2.2 million (17%)** due to a reduction in expenses for clinical research and trials[120](index=120&type=chunk) [Liquidity and Capital Resources](index=30&type=section&id=MD%26A_Liquidity_and_Capital_Resources) As of March 31, 2025, the company maintained strong liquidity with **$110.0 million** in cash and **$125.0 million** available credit, having prepaid its Term Loan Facility - As of March 31, 2025, the company had **$110.0 million** in cash and cash equivalents and **$125.0 million** available for borrowing under its Revolving Facility[125](index=125&type=chunk) - The company prepaid its Term Loan Facility in November 2024 and had no outstanding borrowings under the Term Loan or Revolving Facility as of March 31, 2025[134](index=134&type=chunk)[139](index=139&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=34&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company states that there were no material changes to its market risk disclosures during the three months ended March 31, 2025, as compared to the disclosures in its 2024 Annual Report on Form 10-K - There were no material changes to market risk disclosures during the first quarter of 2025[144](index=144&type=chunk) [Controls and Procedures](index=34&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the principal executive and financial officers, evaluated the company's disclosure controls and procedures and concluded they were effective as of March 31, 2025. There were no material changes in internal control over financial reporting during the quarter - Management concluded that as of March 31, 2025, the company's disclosure controls and procedures are effective[145](index=145&type=chunk) - No material changes to internal controls over financial reporting occurred during the quarter ended March 31, 2025[146](index=146&type=chunk) [PART II. OTHER INFORMATION](index=34&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Legal Proceedings](index=34&type=section&id=Item%201.%20Legal%20Proceedings) The company is contesting a complaint filed by a terminated employee under the U.S. False Claims Act and the Texas State Medicaid Fraud Prevention Act. The U.S. and the State of Texas have declined to intervene. The company believes the claims are without merit and intends to defend itself vigorously - The company was served with a complaint alleging claims under the U.S. False Claims Act and Texas State Medicaid Fraud Prevention Act by a terminated employee[147](index=147&type=chunk) - The United States and the State of Texas declined to intervene in the case in September 2024. The company believes the claims are without merit[147](index=147&type=chunk) [Risk Factors](index=34&type=section&id=Item%201A.%20Risk%20Factors) The primary risk factor highlighted is the new Local Coverage Determinations (LCDs) finalized by seven Medicare Administrative Contractors (MACs). Although implementation has been delayed to January 1, 2026, if they take effect as written, they would classify several of the company's key products as 'non-covered' for diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs). This could have a material adverse effect on the company's business and revenue - New LCDs finalized by seven MACs, if implemented, would classify products like PuraPly, PuraPly AM, PuraPly XT, Novachor, TransCyte, Dual, and Matrix as 'non-covered' for DFUs and VLUs[96](index=96&type=chunk)[151](index=151&type=chunk) - The implementation of these new LCDs has been delayed until **January 1, 2026**, but uncertainty remains about further delays, revisions, or rescission[151](index=151&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=36&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities during the period - None[152](index=152&type=chunk) [Other Information](index=36&type=section&id=Item%205.%20Other%20Information) In March 2025, two company officers, Gary S. Gillheeney, Sr. and Antonio S. Montecalvo, adopted Rule 10b5-1 trading plans to sell shares of the company's Class A common stock, subject to certain conditions - On March 12, 2025, Gary S. Gillheeney, Sr. adopted a Rule 10b5-1 trading plan to sell up to **827,688 shares**[156](index=156&type=chunk) - On March 13, 2025, Antonio S. Montecalvo adopted a Rule 10b5-1 trading plan to sell up to **200,000 shares** (**40,708 common stock** and **159,292** from options)[157](index=157&type=chunk) [Exhibits](index=37&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including corporate governance documents, a lease amendment, a form of performance share award agreement, and officer certifications

[First Quarter 2025 Financial Results](index=1&type=section&id=First%20Quarter%202025%20Financial%20Results) [Q1 2025 Performance Summary](index=1&type=section&id=Q1%202025%20Performance%20Summary) Organogenesis reported a 21% year-over-year decrease in net revenue to $86.7 million for Q1 2025, driven by a 23% decline in the Advanced Wound Care segment, while the Surgical & Sports Medicine segment grew by 11% The company experienced a significant increase in net loss to $18.8 million, compared to a $2.1 million loss in Q1 2024, and an Adjusted EBITDA loss of $12.5 million Management expressed confidence in their commercial strategy despite market challenges and noted progress in the ReNu development plan, with a BLA submission expected by year-end 2025 Q1 2025 Key Financial Metrics vs. Q1 2024 | Metric | Q1 2025 | Q1 2024 | Change | | :--- | :--- | :--- | :--- | | **Net Revenue** | **$86.7M** | **$110.0M** | **-$23.3M (-21%)** | | - Advanced Wound Care | $79.9M | $103.9M | -23% | | - Surgical & Sports Medicine | $6.8M | $6.1M | +11% | | **Net Loss** | **$18.8M** | **$2.1M** | **+$16.7M** | | **Adjusted Net Loss** | **$13.4M** | **$1.4M** | **+$12.0M** | | **Adjusted EBITDA** | **($12.5M)** | **$2.6M** | **-$15.1M** | - CEO Gary S. Gillheeney, Sr. stated the company managed anticipated disruption well and is confident in its ability to execute its commercial strategy for the remainder of the year, leveraging strong brand equity and customer relationships[3](index=3&type=chunk) - The development of ReNu is progressing, with all patients expected to complete the second phase 3 study by the end of Q2 2025 The company remains on track to submit the Biologics License Application (BLA) by the end of 2025[3](index=3&type=chunk) [Detailed Financial Analysis (Q1 2025)](index=2&type=section&id=Detailed%20Financial%20Analysis%20%28Q1%202025%29) In Q1 2025, gross profit fell 23% to $63.0 million with a gross margin of 73%, down from 74% in Q1 2024 Operating expenses increased by 5% to $89.7 million, largely due to a $6.6 million write-down expense for an asset held for sale This led to an operating loss of $26.7 million, a significant increase from the $3.9 million loss in the prior-year period The company ended the quarter with $110.5 million in cash and no debt - Gross profit decreased by **$18.3 million** to **$63.0 million** in Q1 2025, with the gross margin slightly contracting to **73%** from 74% in Q1 2024[6](index=6&type=chunk) - Operating expenses rose **5%** to **$89.7 million**, primarily driven by a new **$6.6 million** write-down expense R&D expenses decreased by 17%, while SG&A expenses remained relatively flat[7](index=7&type=chunk) - The company's cash, cash equivalents, and restricted cash position decreased from **$136.2 million** at the end of 2024 to **$110.5 million** as of March 31, 2025, with no outstanding debt[11](index=11&type=chunk) Q1 2025 vs Q1 2024 Profit and Loss Details | Metric | Q1 2025 | Q1 2024 | Change | | :--- | :--- | :--- | :--- | | **Operating Loss** | **($26.7M)** | **($3.9M)** | **+$22.9M** | | **Net Loss** | **($18.8M)** | **($2.1M)** | **+$16.7M** | | **Net Loss per Share** | **($0.17)** | **($0.02)** | **($0.15)** | [Fiscal Year 2025 Guidance](index=3&type=section&id=Fiscal%20Year%202025%20Guidance) [Full Year 2025 Outlook](index=3&type=section&id=Full%20Year%202025%20Outlook) Organogenesis reaffirmed its full-year 2025 revenue guidance of $480.0 million to $535.0 million, representing a change of flat to 11% growth year-over-year The company updated its profitability guidance, now expecting net income between $4.7 million and $34.0 million, and Adjusted EBITDA between $43.6 million and $83.2 million Fiscal Year 2025 Guidance | Metric | Low End | High End | YoY Change vs. 2024 | | :--- | :--- | :--- | :--- | | **Net Revenue** | **$480.0M** | **$535.0M** | **~0% to +11%** | | - Advanced Wound Care | $450.0M | $500.0M | -1% to +10% | | - Surgical & Sports Medicine | $30.0M | $35.0M | +6% to +23% | | **Net Income** | **$4.7M** | **$34.0M** | N/A | | **Adjusted Net Income** | **$15.3M** | **$44.6M** | N/A | | **EBITDA** | **$20.0M** | **$59.6M** | N/A | | **Adjusted EBITDA** | **$43.6M** | **$83.2M** | N/A | [Consolidated Financial Statements](index=4&type=section&id=Consolidated%20Financial%20Statements) [Consolidated Balance Sheets](index=4&type=section&id=UNAUDITED%20CONSOLIDATED%20BALANCE%20SHEETS) As of March 31, 2025, Organogenesis reported total assets of $467.4 million, a decrease from $497.9 million at year-end 2024 The decline was primarily driven by a reduction in cash and cash equivalents Total liabilities also decreased to $99.3 million from $112.6 million, mainly due to lower accounts payable and accrued expenses Total stockholders' equity stood at $242.9 million Balance Sheet Summary (in thousands) | Account | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Total Current Assets** | **$268,160** | **$285,941** | | Cash and cash equivalents | $109,965 | $135,571 | | Accounts receivable, net | $103,320 | $109,861 | | **Total Assets** | **$467,394** | **$497,886** | | **Total Current Liabilities** | **$65,053** | **$77,477** | | **Total Liabilities** | **$99,325** | **$112,570** | | **Total Stockholders' Equity** | **$242,902** | **$262,897** | [Consolidated Statements of Operations](index=5&type=section&id=UNAUDITED%20CONSOLIDATED%20STATEMENTS%20OF%20OPERATIONS%20AND%20COMPREHENSIVE%20LOSS) For the three months ended March 31, 2025, the company's net revenue was $86.7 million, down from $110.0 million in the prior-year period Gross profit was $63.0 million A loss from operations of $26.7 million was recorded, significantly higher than the $3.9 million loss in Q1 2024 The net loss for the quarter was $18.8 million, or ($0.17) per share, compared to a net loss of $2.1 million, or ($0.02) per share, in Q1 2024 Q1 Statement of Operations (in thousands, except per share data) | Metric | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Net revenue | $86,693 | $109,976 | | Gross profit | $62,970 | $81,280 | | Total operating expenses | $89,716 | $85,132 | | Loss from operations | $(26,746) | $(3,852) | | Net loss | $(18,843) | $(2,100) | | Net loss per share (Basic & Diluted) | $(0.17) | $(0.02) | [Consolidated Statement of Cash Flows](index=6&type=section&id=UNAUDITED%20CONSOLIDATED%20STATEMENT%20OF%20CASH%20FLOWS) In Q1 2025, net cash used in operating activities was $19.9 million, an increase from $10.2 million in Q1 2024 Net cash used in investing activities was $3.6 million for property and equipment purchases Net cash used in financing activities was $2.1 million This resulted in a total decrease in cash, cash equivalents, and restricted cash of $25.6 million for the quarter Q1 Cash Flow Summary (in thousands) | Cash Flow Activity | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(19,935) | $(10,162) | | Net cash used in investing activities | $(3,626) | $(2,222) | | Net cash used in financing activities | $(2,056) | $(2,608) | | **Change in cash, cash equivalents and restricted cash** | **$(25,617)** | **$(14,992)** | | **Cash, cash equivalents, and restricted cash, end of period** | **$110,534** | **$89,346** | [Non-GAAP Financial Measures and Reconciliations](index=7&type=section&id=Non-GAAP%20Financial%20Measures%20and%20Reconciliations) [Reconciliation of GAAP Net Loss to Non-GAAP Adjusted EBITDA](index=7&type=section&id=Reconciliation%20of%20GAAP%20Net%20Loss%20to%20Non-GAAP%20Adjusted%20EBITDA) For Q1 2025, the company reported an Adjusted EBITDA loss of $12.5 million, a significant decrease from an Adjusted EBITDA income of $2.6 million in Q1 2024 The reconciliation from a GAAP net loss of $18.8 million includes adjustments for interest, taxes, D&A, stock-based compensation, and a $6.6 million write-down for an asset held for sale Q1 Adjusted EBITDA Reconciliation (in thousands) | Line Item | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Net loss | $(18,843) | $(2,100) | | Interest (income) expense, net | $(961) | $514 | | Income tax benefit | $(6,940) | $(2,243) | | Depreciation and amortization | $3,444 | $3,072 | | Amortization of intangible assets | $842 | $901 | | **EBITDA** | **$(22,458)** | **$144** | | Stock-based compensation expense | $3,367 | $2,407 | | Write-down to fair value for asset held for sale | $6,567 | $— | | **Adjusted EBITDA** | **$(12,524)** | **$2,551** | [Reconciliation of GAAP Net Loss to Non-GAAP Adjusted Net Loss](index=8&type=section&id=Reconciliation%20of%20GAAP%20Net%20Loss%20to%20Non-GAAP%20Adjusted%20Net%20Loss) The company's adjusted net loss for Q1 2025 was $13.4 million, compared to an adjusted net loss of $1.4 million in Q1 2024 The adjustment from the GAAP net loss of $18.8 million primarily accounts for the amortization of intangible assets and the write-down of an asset held for sale, net of tax effects Q1 Adjusted Net Loss Reconciliation (in thousands) | Line Item | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Net loss | $(18,843) | $(2,100) | | Amortization of intangible assets | $842 | $901 | | Write-down to fair value for asset held for sale | $6,567 | $— | | Tax on above | $(2,000) | $(241) | | **Adjusted net loss** | **$(13,434)** | **$(1,440)** | [Reconciliation of GAAP Loss from Operations to Non-GAAP Operating Loss](index=8&type=section&id=Reconciliation%20of%20GAAP%20Loss%20from%20Operations%20to%20Non-GAAP%20Operating%20Loss) Non-GAAP operating loss for Q1 2025 was $19.3 million, an increase from a $3.0 million loss in the prior-year quarter This figure is derived from the GAAP operating loss of $26.7 million by adding back the amortization of intangible assets and the write-down for an asset held for sale Q1 Non-GAAP Operating Loss Reconciliation (in thousands) | Line Item | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Loss from operations | $(26,746) | $(3,852) | | Amortization of intangible assets | $842 | $901 | | Write-down to fair value for asset held for sale | $6,567 | $— | | **Non-GAAP operating loss** | **$(19,337)** | **$(2,951)** | [Projected Non-GAAP Reconciliations for Fiscal Year 2025](index=8&type=section&id=Projected%20Non-GAAP%20Reconciliations%20for%20Fiscal%20Year%202025) For the full fiscal year 2025, the company provided reconciliations for its guidance Projected GAAP net income of $4.7 million to $34.0 million is expected to reconcile to an Adjusted EBITDA of $43.6 million to $83.2 million Similarly, projected adjusted net income is expected to be between $15.3 million and $44.6 million FY2025 Projected GAAP Net Income to Adjusted EBITDA (in thousands) | Line Item | 2025 Low | 2025 High | | :--- | :--- | :--- | | Net income | $4,700 | $34,000 | | Adjustments (Interest, Tax, D&A, etc.) | $15,300 | $25,600 | | **EBITDA** | **$20,000** | **$59,600** | | Additional Adjustments (Stock Comp, Write-down, FDA fee) | $23,600 | $23,600 | | **Adjusted EBITDA** | **$43,600** | **$83,200** | FY2025 Projected GAAP Net Income to Adjusted Net Income (in thousands) | Line Item | 2025 Low | 2025 High | | :--- | :--- | :--- | | Net income | $4,700 | $34,000 | | Adjustments (Amortization, Write-down, FDA fee) | $14,500 | $14,500 | | Tax on above | $(3,900) | $(3,900) | | **Adjusted net income** | **$15,300** | **$44,600** | [Other Information](index=10&type=section&id=Other%20Information) [Forward-Looking Statements](index=10&type=section&id=Forward-Looking%20Statements) This report contains forward-looking statements regarding the company's expected financial performance for fiscal 2025 and strategic plans These statements are subject to numerous risks and uncertainties, including changes in product reimbursement levels, competition, technological changes, the ability to raise funds, and regulatory approvals, which could cause actual results to differ materially from expectations - Forward-looking statements include guidance on revenue, net income, and EBITDA for fiscal 2025[26](index=26&type=chunk) - Key risks include uncertainty in coverage and reimbursement (including proposed LCDs effective as soon as Jan 1, 2026), significant competition, rapid technological change, and the ability to obtain regulatory approval for products like ReNu[26](index=26&type=chunk) [About Organogenesis Holdings Inc.](index=11&type=section&id=About%20Organogenesis%20Holdings%20Inc.) Organogenesis Holdings Inc. is a leading regenerative medicine company that develops, manufactures, and commercializes solutions for the advanced wound care and surgical and sports medicine markets, offering a comprehensive portfolio of innovative products - The company focuses on regenerative medicine solutions for advanced wound care and surgical/sports medicine markets[27](index=27&type=chunk)

Core Viewpoint - Organogenesis Holdings Inc. reported a significant decline in net revenue for the first quarter of 2025, primarily due to a decrease in Advanced Wound Care product sales, while Surgical & Sports Medicine products showed growth. The company remains optimistic about its commercial strategy and ongoing product development, particularly the ReNu project [1][3][4]. Financial Performance - Net revenue for Q1 2025 was $86.7 million, down from $110.0 million in Q1 2024, representing a decrease of $23.3 million or 21% [4][7]. - Advanced Wound Care products generated $79.9 million in revenue, a decrease of 23% year-over-year, while Surgical & Sports Medicine products saw an increase to $6.8 million, up 11% [4][7]. - Gross profit for Q1 2025 was $63.0 million, or 73% of net revenue, compared to $81.3 million, or 74% of net revenue in Q1 2024, marking a decrease of $18.3 million or 23% [5]. - Operating expenses rose to $89.7 million, an increase of 5% from $85.1 million in Q1 2024, with R&D expenses decreasing by 17% to $10.6 million [6]. - The company reported a net loss of $18.8 million for Q1 2025, compared to a net loss of $2.1 million in Q1 2024, reflecting an increase in net loss of $16.7 million [9][10]. Cash Position - As of March 31, 2025, the company had $110.5 million in cash and cash equivalents, down from $136.2 million at the end of 2024, with no outstanding debt [11]. Guidance for Fiscal Year 2025 - The company reaffirmed its revenue guidance for 2025, expecting net revenue between $480.0 million and $535.0 million, which represents a year-over-year change of roughly flat to an increase of 11% [12][14]. - Expected net revenue from Advanced Wound Care products is projected to be between $450.0 million and $500.0 million, while Surgical & Sports Medicine products are expected to generate between $30.0 million and $35.0 million [14].

Core Viewpoint - Organogenesis supports the U.S. Centers for Medicare & Medicaid Services' (CMS) decision to delay local coverage determinations (LCDs) for skin substitute grafts and cellular and tissue-based products to review coverage policies, emphasizing the importance of high-quality evidence of effectiveness for patient access [1][2] Group 1: Company Position and Recommendations - The company advocates for an integrated coverage and payment policy to address rising Medicare costs while ensuring patient access to effective products [2] - Organogenesis has been a leader in regenerative medicine for four decades, innovating in advanced wound care therapies and bioengineered living cell products [2] - The company emphasizes the role of real-world evidence in demonstrating product safety, efficacy, and clinical outcomes [2] Group 2: Company Overview - Organogenesis Holdings Inc. focuses on the development, manufacture, and commercialization of solutions for advanced wound care and surgical and sports medicine markets [3] - The company offers a comprehensive portfolio of innovative regenerative products to meet patient needs across the continuum of care [3]

Core Viewpoint - Organogenesis Holdings Inc. will report its first quarter financial results for fiscal year 2025 on May 8, 2025, after market close [1] Group 1: Financial Reporting - The financial results will be discussed in a conference call scheduled for 5:00 p.m. Eastern Time on the same day [2] - Participants can access the live webcast through the company's website, and the webcast will be archived for approximately one year [2] Group 2: Company Overview - Organogenesis Holdings Inc. is a leading company in regenerative medicine, focusing on advanced wound care and surgical and sports medicine markets [3] - The company offers a comprehensive portfolio of innovative regenerative products to meet patient needs across the continuum of care [3]

Organogenesis Holdings Inc. (NASDAQ:ORGO) Q4 2024 Earnings Conference Call February 27, 2025 5:00 PM ET Company Participants Gary S. Gillheeney, Sr. – President and Chief Executive Officer Dave Francisco – Chief Financial Officer Conference Call Participants Brooks O'Neil – Lake Street Capital Markets Ross Osborn – Cantor Fitzgerald Ryan Zimmerman – BTIG Operator Please standby. Welcome, ladies and gentlemen, to the Fourth Quarter and Fiscal Year 2024 Earnings Conference Call for Organogenesis Holdings, Inc ...