Financial Data and Key Metrics Changes - The company reported net revenue for Q4 2024 of $126.7 million, a 27% increase year-over-year, exceeding previous guidance [14][16] - Gross profit for Q4 was $96 million, representing 75.5% of net revenue, up from 72.1% the previous year [14][15] - GAAP net income for Q4 was $7.7 million, compared to a net loss of $0.6 million last year, marking an increase of $8.3 million [15][16] - Adjusted EBITDA for Q4 was $18.2 million, or 14.4% of net revenue, compared to $7.5 million or 7.5% of net revenue last year [16] Business Line Data and Key Metrics Changes - Advanced Wound Care net revenue for Q4 was $119 million, up 27% year-over-year [14][16] - Net revenue from surgical and sports medicine products for Q4 was $8 million, an increase of 24% [14][16] - For the full year 2024, net revenue was $482 million, an 11% increase from $433.1 million in 2023, driven by a 12% increase in Advanced Wound Care products [16] Market Data and Key Metrics Changes - The company anticipates a challenging operating environment in the first half of 2025 due to delays in the implementation of LCDs, with expectations for improvement in the second half [8][20] - The final LCD ruling will affect 18 products, including key offerings like Aplograph and Dermagraft, while over 200 products will be classified as non-covered [9][10] Company Strategy and Development Direction - The company is focused on gathering clinical and real-world outcomes data to enhance its product portfolio and market penetration [10] - The RENEW program is a key strategic focus, with plans for a BLA submission by the end of 2025, targeting a large pain management market [12][14] - The company is advocating for a value-based payment methodology for skin substitute products to improve patient access and reduce Medicare expenditures [7][10] Management's Comments on Operating Environment and Future Outlook - Management noted that the delayed effective date for the final LCD ruling has created ambiguity and disruption in customer behavior, impacting demand [8][9] - The company expects significant improvement in business trends beginning in Q3 2025, following the implementation of the LCDs [20] - Management expressed confidence that the LCDs will be implemented as scheduled, despite potential for confusion in the market [36][38] Other Important Information - The company ended Q4 2024 with $136.2 million in cash and no outstanding debt, a significant improvement from $104.3 million in cash and $66.2 million in net debt obligations at the end of 2023 [17] - The company introduced financial guidance for 2025, expecting net revenue between $480 million and $535 million, with a focus on Advanced Wound Care products [18][19] Q&A Session Summary Question: Market competitiveness and customer behavior - Management indicated that there has not been a major change in the competitive environment, but customer buying behavior has shifted due to reimbursement dynamics [22][23] Question: Timeline for RENEW product submission - The company expects to file the BLA submission by the end of 2025 and anticipates FDA feedback in Q4 2026, with potential approval by late 2026 or early 2027 [25] Question: Sales force attrition and retention - Some attrition was noted, but it was not significant, and the company has successfully backfilled positions with good talent [29] Question: Progress on RCTs for non-covered products - The company expects to have an interim analysis for the PuraPly study in Q4 2025, with publication anticipated in Q1 2026 [30] Question: Assumptions regarding LCD implementation - Management believes the LCD will be implemented as planned, with no significant delays expected, despite potential for rescission [36][38]

Financial Data and Key Metrics Changes - The company reported net revenue for Q4 2024 of $126.7 million, a 27% increase year-over-year, exceeding previous guidance [15][19] - Gross profit for Q4 was $96 million, representing 75.5% of net revenue, up from 72.1% the previous year [15][16] - Operating income for Q4 was $10.2 million, compared to an operating loss of $1.3 million last year, marking an increase of $11.5 million [16] - GAAP net income for Q4 was $7.7 million, compared to a net loss of $0.6 million last year, an increase of $8.3 million [16] - Adjusted EBITDA for Q4 was $18.2 million, or 14.4% of net revenue, compared to $7.5 million or 7.5% of net revenue last year [17] Business Line Data and Key Metrics Changes - Advanced Wound Care net revenue for Q4 was $119 million, up 27% year-over-year [15] - Net revenue from surgical and sports medicine products for Q4 was $8 million, an increase of 24% [15] Market Data and Key Metrics Changes - The company anticipates a challenging operating environment in the first half of 2025 due to delays in the implementation of LCDs, with expectations for improvement in the second half [9][21] - The final LCD ruling will affect 18 products, including key offerings like Aplograph and Dermagraft, while over 200 products will be classified as non-covered [10] Company Strategy and Development Direction - The company is focused on gathering robust clinical and real-world outcomes data to enhance its product portfolio and market penetration [11] - The RENEW program is a key strategic focus, with plans for a BLA submission by the end of 2025, targeting a large pain management market [14][15] Management's Comments on Operating Environment and Future Outlook - Management noted that the stronger customer demand in Q4 was due to less disruption in the marketplace related to the delayed effective date for the final LCD ruling [6][9] - The company expects significant improvement in business trends beginning in Q3 2025, following the implementation of the LCDs [10][21] Other Important Information - The company had $136.2 million in cash and cash equivalents as of December 31, 2024, with no outstanding debt obligations [18] - Financial guidance for 2025 includes net revenue expectations between $480 million and $535 million, with a focus on Advanced Wound Care products [19][20] Q&A Session Summary Question: Market competitiveness and customer behavior - Management indicated that there is no major change in the competitive environment, but customer buying behavior has shifted due to reimbursement dynamics [23][24] Question: Timeline for RENEW product submission - The company expects to file the BLA submission at the end of 2025 and anticipates FDA feedback in Q4 2026, with potential approval by late 2026 or early 2027 [26][27] Question: Sales force attrition and retention - Some attrition was noted, but it was not significant, and the company has successfully backfilled positions [31] Question: Progress on RCTs for non-covered products - The PuraPly study is expected to have an interim analysis in Q4 2025, with publication anticipated in Q1 2026 [32] Question: Assumptions regarding LCD implementation - Management believes the LCD will be implemented as planned, despite potential for rescission if CMS is dissatisfied [38][40]

Part I [Business](index=6&type=section&id=Item%201.%20Business) Organogenesis is a regenerative medicine company specializing in advanced wound care and surgical/sports medicine products with a focus on leveraging its broad portfolio and expanding market penetration [Overview](index=6&type=section&id=Overview) The company develops and sells regenerative medicine products for the advanced wound care and surgical & sports medicine markets - Organogenesis is a regenerative medicine company focused on developing and selling products for the advanced wound care and surgical & sports medicine markets[22](index=22&type=chunk) - The company's product portfolio includes solutions with Premarket Application (PMA) approval or 510(k) clearance from the FDA, targeting markets driven by an aging population and comorbidities like diabetes and obesity[23](index=23&type=chunk) [Recent Developments](index=6&type=section&id=Recent%20Developments) Key developments include a **$130.0 million** financing, a new manufacturing facility lease, and a licensing agreement with Vivex Biologics - In November 2024, the company raised **$130.0 million** in gross proceeds through the sale of 130,000 shares of Series A Convertible Preferred Stock to Avista Healthcare Partners[31](index=31&type=chunk) - Approximately **$25.5 million** of the proceeds from the financing were used to repurchase 7,921,731 shares of Class A common stock from existing stockholders[31](index=31&type=chunk) - The company entered into a lease for a 122,000-square foot biomanufacturing facility in Smithfield, Rhode Island, with manufacturing of Dermagraft, Apligraf, and PuraPly expected to commence in 2027[28](index=28&type=chunk) - Entered into a trademark license and manufacturing agreement with Vivex Biologics, Inc for its CYGNUS and VIA Matrix products, involving an upfront fee, milestone payments, and royalties[26](index=26&type=chunk)[27](index=27&type=chunk) [Market Overview](index=10&type=section&id=Market%20Overview) The company targets a global wound care market estimated at **$20 billion** and an osteoarthritis market estimated at **$7 billion** - The global total addressable market for acute and chronic wounds was estimated at approximately **$20 billion** as of 2021[37](index=37&type=chunk) - The total addressable market for osteoarthritis (OA) was estimated at approximately **$7 billion** as of 2023, a key target for the company's Surgical & Sports Medicine pipeline[41](index=41&type=chunk) [Our Commercial Products](index=12&type=section&id=Our%20Commercial%20Products) The product portfolio includes PMA-approved, 510(k)-cleared, and Section 361 HCT/P regulated solutions for wound care - Apligraf is the only product with PMA approval for both venous leg ulcers (VLUs) and diabetic foot ulcers (DFUs)[44](index=44&type=chunk) - Manufacturing and sales of Dermagraft, a PMA-approved product for DFUs, were suspended in 2021-2022, with plans to resume at a new facility in 2027[45](index=45&type=chunk) - The portfolio includes placental allografts such as Affinity, Novachor, and NuShield, which are regulated as Section 361 HCT/Ps[43](index=43&type=chunk)[46](index=46&type=chunk) - PuraPly AM, a 510(k) cleared product, is a collagen matrix with PHMB antimicrobial for managing various wound types[47](index=47&type=chunk) [Our Business Strategy](index=14&type=section&id=Our%20Business%20Strategy) The business strategy focuses on deepening market penetration, developing the product pipeline, and expanding sales reach - Deepen presence in the Advanced Wound Care market by leveraging a comprehensive product portfolio and investing in clinical data to support physician and payer education[53](index=53&type=chunk) - Accelerate penetration into the Surgical & Sports Medicine market using placental-based and collagen products, leveraging the existing commercial infrastructure[54](index=54&type=chunk) - Continue to develop a robust product pipeline for both markets, with new products expected to launch in the next few years[55](index=55&type=chunk) - Expand sales reach by optimizing the sales organization, broadening geographic footprint, and increasing focus on sales outside the United States[56](index=56&type=chunk)[57](index=57&type=chunk) [Product Pipeline and Clinical Studies](index=16&type=section&id=Product%20Pipeline%20and%20Clinical%20Studies) The product pipeline includes line extensions and new products, with a Phase 3 study for ReNu in knee osteoarthritis ongoing - The pipeline includes line extensions for PuraPly, Apligraf, and Dermagraft, as well as new products like FortiShield (biosynthetic wound matrix) and TransCyte (bioengineered tissue for burns)[60](index=60&type=chunk)[62](index=62&type=chunk)[63](index=63&type=chunk)[64](index=64&type=chunk) - A Phase 3 clinical study for ReNu in symptomatic knee osteoarthritis (OA) is ongoing, with a biologics license application (BLA) submission expected in the second half of 2025[25](index=25&type=chunk)[68](index=68&type=chunk) - The first Phase 3 trial for ReNu met its primary endpoint, showing a **statistically significant reduction in knee pain (p=0.0177)** at six months[67](index=67&type=chunk) [Commercial Infrastructure, Manufacturing, and Regulation](index=18&type=section&id=Commercial%20Infrastructure%2C%20Manufacturing%2C%20and%20Regulation) The company utilizes a large direct and independent sales force, in-house and third-party manufacturing, and navigates multiple FDA regulatory pathways - As of December 31, 2024, the commercial team consisted of **256 direct sales representatives** and approximately **160 independent agencies**[69](index=69&type=chunk) - The company manufactures its primary non-placental products in-house and uses third-party manufacturers for placental-based products[74](index=74&type=chunk) - Products are regulated through various FDA pathways, including PMA (Apligraf, Dermagraft), 510(k) clearance (PuraPly), and as Section 361 HCT/Ps (Affinity, NuShield)[43](index=43&type=chunk)[44](index=44&type=chunk)[47](index=47&type=chunk)[78](index=78&type=chunk)[83](index=83&type=chunk) - Reimbursement is critical and relies on coverage from Medicare, Medicaid, and private payers; Medicare payment for products is bundled in outpatient hospital settings but paid separately based on Average Sales Price (ASP) in physician offices[88](index=88&type=chunk)[93](index=93&type=chunk) [Risk Factors](index=29&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks from payer reimbursement policies, supplier dependency, regulatory changes, and stockholder concentration - The company's success is highly dependent on coverage and reimbursement from government and private payers, which is unstable and subject to policy changes like **Medicare LCDs**[18](index=18&type=chunk) - Finalized Medicare LCDs, with a delayed implementation until April 13, 2025, would render over 200 products, including the company's PuraPly, Novachor, and others, as **"non-covered"** for DFU and VLU indications, which could materially impact revenue[204](index=204&type=chunk)[312](index=312&type=chunk) - There is a risk that the FDA may determine that placental products like Affinity, Novachor, and NuShield do not qualify for regulation solely under Section 361 of the PHSA, which could require suspension of sales until more stringent FDA approval is obtained[19](index=19&type=chunk)[161](index=161&type=chunk)[163](index=163&type=chunk) - The company depends on a limited group of suppliers and manufacturers for key products, and any interruption could cause material delivery delays and impact sales[20](index=20&type=chunk)[112](index=112&type=chunk) - The Significant Stockholder Group beneficially owns approximately **40% of the Class A common stock**, allowing them to effectively determine the outcome of all matters requiring stockholder approval[239](index=239&type=chunk) [Unresolved Staff Comments](index=85&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments) The company reports no unresolved staff comments from the SEC - None[279](index=279&type=chunk) [Cybersecurity](index=85&type=section&id=Item%201C.%20Cybersecurity) The company manages cybersecurity risk through a program based on the NIST Framework with oversight from the Audit Committee - The company's cybersecurity strategy is managed by an internal information security team and utilizes the **NIST Cybersecurity Framework** for assessing and monitoring threats[281](index=281&type=chunk) - Governance is provided by the **Audit Committee of the Board of Directors**, which receives quarterly updates on the cybersecurity program[285](index=285&type=chunk) - The company engages third-party cybersecurity partners for monitoring, penetration testing, and vulnerability assessments[283](index=283&type=chunk) [Properties](index=85&type=section&id=Item%202.%20Properties) The company's main operations are in Massachusetts, with a new 122,000-square-foot manufacturing facility being added in Rhode Island | Location | Size (sq. ft.) | Use | Notes | | :--- | :--- | :--- | :--- | | Canton, MA | ~300,000 | Corporate HQ, manufacturing, R&D | Four-building campus. Three buildings leased from related parties. | | Norwood, MA | ~43,850 | Office, lab, manufacturing | Leased facility. | | Smithfield, RI | ~122,000 | Manufacturing, office | New lease signed Nov 2024; manufacturing to start in 2027. | | AL, CA, FL, MA | Smaller | Manufacturing, warehouse, office, lab | Various smaller leased facilities. | [Legal Proceedings](index=87&type=section&id=Item%203.%20Legal%20Proceedings) The company is defending a False Claims Act lawsuit filed by a terminated employee, which it believes is without merit - On January 22, 2025, the company was served with a complaint alleging claims under the U.S. False Claims Act and Texas Medicaid Fraud Prevention Act, brought by a terminated employee[291](index=291&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[291](index=291&type=chunk) [Mine Safety Disclosures](index=87&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[293](index=293&type=chunk) Part II [Market For Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=88&type=section&id=Item%205.%20Market%20For%20Registrant's%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) The company's stock trades on Nasdaq under "ORGO", and **7.9 million shares** were repurchased in November 2024 for **$25.5 million** - The company's Class A common stock is listed on the Nasdaq Capital Market under the symbol **ORGO**[296](index=296&type=chunk) - The company has never declared or paid cash dividends and does not expect to in the foreseeable future[297](index=297&type=chunk) Issuer Purchases of Equity Securities (Q4 2024) | Period | Total Shares Purchased | Average Price Paid per Share | | :--- | :--- | :--- | | October 2024 | — | $-- | | November 2024 | 7,921,731 | $3.2163 | | December 2024 | — | $-- | | **Total Q4 2024** | **7,921,731** | **N/A** | [Reserved](index=90&type=section&id=Item%206.%20Reserved) This item is reserved - Reserved[304](index=304&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=91&type=section&id=Item%207.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Fiscal year 2024 saw an 11% revenue increase to **$482.0 million**, but a net loss from operations of **$1.3 million** due to impairment charges [Results of Operations](index=97&type=section&id=Results%20of%20Operations) Revenue growth was driven by Advanced Wound Care, while operating income declined due to impairment and software write-downs Fiscal Year Performance Comparison | Metric | FY 2024 | FY 2023 | YoY Change | | :--- | :--- | :--- | :--- | | Net Revenue | $482.0M | $433.1M | +11% | | - Advanced Wound Care | $453.6M | $405.5M | +12% | | - Surgical & Sports Medicine | $28.4M | $27.6M | +3% | | Gross Profit | $366.3M | $326.7M | +12% | | Income (Loss) from Operations | ($1.3M) | $12.5M | -110% | | Net Income | $0.9M | $4.9M | -82% | | Adjusted EBITDA | $49.8M | $42.6M | +17% | - The increase in 2024 revenue was primarily driven by a **$48.1 million (12%)** increase in Advanced Wound Care product sales from new and existing customers[339](index=339&type=chunk) - Operating expenses in 2024 included a one-time impairment charge of **$18.8 million** for property and construction and a **$4.0 million** write-down of capitalized internal-use software costs[334](index=334&type=chunk)[350](index=350&type=chunk) - Selling, general and administrative (SG&A) expenses increased by **9%** in 2024, mainly due to a **$19.8 million** increase in royalty expense[346](index=346&type=chunk) - Research and development (R&D) expenses grew **13%** in 2024, driven by increased clinical research and consulting costs for pipeline products[348](index=348&type=chunk) [Liquidity and Capital Resources](index=102&type=section&id=Liquidity%20and%20Capital%20Resources) The company's liquidity improved with **$135.6 million** in cash, bolstered by a **$130 million** financing used to repay debt and repurchase stock Key Financial Position Metrics | Metric | Dec 31, 2024 | Dec 31, 2023 | | :--- | :--- | :--- | | Cash and cash equivalents | $135.6M | $103.8M | | Working Capital | $208.5M | $144.5M | | Total Debt | $1.9M | $69.2M | - In November 2024, the company raised net proceeds of **$120.6 million** from a Series A Convertible Preferred Stock issuance[355](index=355&type=chunk) - The company used **$66.6 million** of the proceeds to fully repay its Term Loan Facility and **$25.5 million** to repurchase common stock[355](index=355&type=chunk)[365](index=365&type=chunk) - Net cash provided by operating activities was **$14.2 million** in 2024, a decrease from **$30.9 million** in 2023, primarily due to a **$31.8 million** increase in accounts receivable[360](index=360&type=chunk)[361](index=361&type=chunk) - The company has **$125.0 million** available for future borrowing under its Revolving Facility[356](index=356&type=chunk)[374](index=374&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=109&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's exposure to market risks, primarily foreign currency exchange rates, is not considered material - The company's primary market risk is foreign currency exchange rate variability, but exposure is considered minimal due to the short duration of foreign currency contracts[382](index=382&type=chunk)[383](index=383&type=chunk) [Financial Statements and Supplementary Data](index=109&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) This section refers to the consolidated financial statements and auditor's report included elsewhere in the Annual Report - The company's consolidated financial statements and the auditor's report are located in a subsequent section of the 10-K[384](index=384&type=chunk) [Changes in and Disagreements with Accountants on Accounting and Financial Disclosure](index=109&type=section&id=Item%209.%20Changes%20in%20and%20Disagreements%20with%20Accountants%20on%20Accounting%20and%20Financial%20Disclosure) The company reports no changes in or disagreements with its accountants on accounting and financial disclosure - None[385](index=385&type=chunk) [Controls and Procedures](index=109&type=section&id=Item%209A.%20Controls%20and%20Procedures) Disclosure controls were deemed effective, and a previously identified material weakness in internal control has been remediated - Management concluded that disclosure controls and procedures were **effective** as of December 31, 2024[387](index=387&type=chunk) - A previously reported material weakness related to IT general controls and segregation of duties was **remediated** as of December 31, 2024[391](index=391&type=chunk)[392](index=392&type=chunk) - Remediation actions included implementing a new ERP system, adding experienced accounting personnel, and designing new IT general controls[392](index=392&type=chunk) [Other Information](index=113&type=section&id=Item%209B.%20Other%20Information) No directors or officers adopted or terminated Rule 10b5-1 trading arrangements during the fourth quarter of 2024 - No director or officer adopted or terminated a Rule 10b5-1 trading plan in Q4 2024[395](index=395&type=chunk) [Disclosure Regarding Foreign Jurisdictions that Prevent Inspections](index=113&type=section&id=Item%209C.%20Disclosure%20Regarding%20Foreign%20Jurisdictions%20that%20Prevent%20Inspections) This item is not applicable to the company - Not applicable[396](index=396&type=chunk) Part III [Directors, Executive Officers and Corporate Governance](index=114&type=section&id=Item%2010.%20Directors%2C%20Executive%20Officers%20and%20Corporate%20Governance) Required information will be provided in the company's Definitive Proxy Statement and is incorporated by reference [Executive Compensation](index=114&type=section&id=Item%2011.%20Executive%20Compensation) Required information will be provided in the company's Definitive Proxy Statement and is incorporated by reference [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=114&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) Required information will be provided in the company's Definitive Proxy Statement and is incorporated by reference [Certain Relationships and Related Transactions, and Director Independence](index=114&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions%2C%20and%20Director%20Independence) Required information will be provided in the company's Definitive Proxy Statement and is incorporated by reference [Principal Accounting Fees and Services](index=114&type=section&id=Item%2014.%20Principal%20Accounting%20Fees%20and%20Services) Required information will be provided in the company's Definitive Proxy Statement and is incorporated by reference Part IV [Exhibits and Financial Statement Schedules](index=115&type=section&id=Item%2015.%20Exhibits%20and%20Financial%20Statement%20Schedules) This section lists the documents filed as part of the Form 10-K report, including financial statements and material contracts [Form 10-K Summary](index=121&type=section&id=Item%2016.%20Form%2010-K%20Summary) The company reports no Form 10-K summary - None[413](index=413&type=chunk) Financial Statements and Notes [Report of Independent Registered Public Accounting Firm](index=124&type=section&id=Report%20of%20Independent%20Registered%20Public%20Accounting%20Firm) RSM US LLP issued an unqualified opinion, highlighting Critical Audit Matters related to impairment valuation and preferred stock accounting - The auditor issued an **unqualified opinion** on the financial statements and the effectiveness of internal control over financial reporting[422](index=422&type=chunk)[423](index=423&type=chunk) - Two **Critical Audit Matters** were identified: the determination of fair value for an impaired building and the accounting for the new redeemable convertible preferred stock[426](index=426&type=chunk)[427](index=427&type=chunk)[432](index=432&type=chunk) [Consolidated Financial Statements](index=129&type=section&id=Consolidated%20Financial%20Statements) Total assets grew to **$497.9 million** while liabilities decreased to **$112.6 million** following debt repayment, with net income of **$0.9 million** for FY 2024 Consolidated Balance Sheet Summary (in thousands) | | Dec 31, 2024 | Dec 31, 2023 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $135,571 | $103,840 | | Accounts receivable, net | $109,861 | $81,999 | | Total current assets | $285,941 | $225,044 | | Total assets | $497,886 | $460,025 | | **Liabilities & Equity** | | | | Total current liabilities | $77,477 | $80,509 | | Term loan, net | $0 | $66,231 | | Total liabilities | $112,570 | $181,362 | | Redeemable convertible preferred stock | $122,419 | $0 | | Total stockholders' equity | $262,897 | $278,663 | Consolidated Statement of Operations Summary (in thousands) | | FY 2024 | FY 2023 | FY 2022 | | :--- | :--- | :--- | :--- | | Net revenue | $482,043 | $433,140 | $450,893 | | Gross profit | $366,302 | $326,659 | $345,874 | | Income (loss) from operations | ($1,283) | $12,525 | $22,304 | | Net income | $861 | $4,945 | $15,532 | | Net income (loss) attributable to common stockholders | ($937) | $4,945 | $15,532 | [Notes to Consolidated Financial Statements](index=133&type=section&id=Notes%20to%20Consolidated%20Financial%20Statements) Notes detail an **$18.8 million** impairment charge, the issuance of **$130 million** in preferred stock, and a **$25.5 million** common stock repurchase - In Q2 2024, the company recorded an impairment charge of **$18.8 million** on a purchased building and associated construction in Canton, MA, reducing its carrying value to a fair value of **$13.6 million**; a write-down of **$4.0 million** for capitalized internal-use software was also recorded[513](index=513&type=chunk)[519](index=519&type=chunk)[520](index=520&type=chunk) - The company issued 130,000 shares of Series A Redeemable Convertible Preferred Stock for gross proceeds of **$130 million**; the stock carries an **8.0% dividend** (payable in cash or in-kind) and is classified as mezzanine equity due to holder redemption rights[542](index=542&type=chunk)[544](index=544&type=chunk)[551](index=551&type=chunk) - In November 2024, the company repurchased and retired 7,921,731 shares of its Class A common stock from existing stockholders, including directors and their affiliates, for a total cost of **$25.5 million**[542](index=542&type=chunk)[553](index=553&type=chunk)[554](index=554&type=chunk) - The company fully repaid its Term Loan Facility in November 2024; as of December 31, 2024, there were no outstanding borrowings under the Term Loan or the **$125 million** Revolving Facility[534](index=534&type=chunk)[537](index=537&type=chunk)[541](index=541&type=chunk)

Exhibit 99.1 FOR IMMEDIATE RELEASE Organogenesis Holdings Inc. Reports Fourth Quarter 2024 Financial Results Fourth Quarter 2024 Financial Results Summary: Fiscal Year 2024 Financial Results Summary: • Net revenue of $126.7 million for the fourth quarter of 2024, an increase of $27.0 million compared to net revenue of $99.7 million for the fourth quarter of 2023. Net revenue for the fourth quarter of 2024 consists of: o Net revenue from Advanced Wound Care products of $118.6 million, an increase of 27% from ...

CANTON, Mass., Feb. 27, 2025 (GLOBE NEWSWIRE) -- Organogenesis Holdings Inc. (Nasdaq: ORGO), a leading regenerative medicine and tissue innovations company focused on empowering healing through the development, manufacturing, and sale of products for the advanced wound care, and surgical and sports medicine markets, today reported financial results for the fourth quarter and the year ended December 31, 2024. Fourth Quarter 2024 Financial Results Summary: Net revenue of $126.7 million for the fourth quarter ...

CANTON, Mass., Jan. 27, 2025 (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 and Sports Medicine markets, today announced that fourth quarter and fiscal year 2024 financial results will be reported after the market closes on Thursday, February 27th. Management will host a conference call at 5:00 p.m. Eastern Time on February 27th ...

CANTON, Mass., Nov. 22, 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 and Sports Medicine markets, announced plans to expand manufacturing capacity with a long-term lease for a 122,000-square foot state-of-the-art biomanufacturing facility located at 100 Technology Way in Smithfield, Rhode Island. “We are pleased to join t ...

CANTON, Mass., Nov. 15, 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 and Sports Medicine markets, commends today’s decision by the U.S. Centers for Medicare & Medicaid Services (CMS) on local coverage determination (LCD) based on peer-reviewed and evidence-based data of clinical efficacy. The LCD covers skin substitute g ...

Financial Data and Key Metrics Changes - Net revenue for Q3 2024 was $115.2 million, up 6% year-over-year, exceeding previous guidance [25] - Gross profit for Q3 was $88 million, representing 76.7% of net revenue, compared to 76.2% last year [26] - Operating income decreased to $6.2 million from $8.1 million year-over-year, a decline of 22% [27] - Adjusted net income increased to $12.9 million from $5.3 million year-over-year, primarily due to a change in income tax [28] - Adjusted EBITDA for Q3 was $13.4 million, or 12% of net revenue, down from 14.7% last year [29] Business Line Data and Key Metrics Changes - Advanced wound care net revenue was $108 million, up 7% year-over-year [26] - Net revenue from surgical and sports medicine products was $7 million, up 1% [26] Market Data and Key Metrics Changes - The company expects net revenue for 2024 to be between $455 million and $480 million, representing a year-over-year increase of 5% to 11% [32] - Advanced wound care products are expected to generate revenue between $429 million and $452 million, a year-over-year increase of 6% to 11% [33] Company Strategy and Development Direction - The company is focused on leveraging clinical data to secure coverage for additional products and is actively engaging with CMS for payment reform [22][37] - The RENEW program is on track for a BLA submission by the end of Q4 2025, which could transform pain management for knee osteoarthritis [11][38] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in navigating the challenging operating environment and highlighted strong execution from the commercial team [7][35] - The company anticipates potential near-term disruptions in Q4 due to LCDs but remains optimistic about long-term growth opportunities [32][49] Other Important Information - The company completed a private placement of Series A convertible preferred stock, raising $100 million to fund strategic growth initiatives [30][31] - CMS has not proposed changes to payment policies for skin substitutes for 2025, but the company is advocating for a value-based payment methodology [16][19] Q&A Session Summary Question: Update on broadening the salesforce and focus on sports medicine - The company increased its rep count in the quarter, with good performance noted, particularly in wound care [42] Question: Insights on operating expenses and R&D spending - R&D expenses were lower than expected, with a return to Q2 spending levels anticipated in Q4 [43][44] Question: Guidance for Q4 and impacts from LCDs - The company expects limited impact in Q3 but maintains a wide range for Q4 guidance due to potential customer spending pullback [46][49] Question: Timeline for RENEW program and interim analysis - The last patient visit was completed in June, with an interim analysis expected by Q4, keeping the BLA submission on track for Q4 2025 [50][51]

CANTON, Mass., Nov. 12, 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 announced that it has entered into a Subscription Agreement with affiliates of Avista Healthcare Partners (“Investors”) for the sale of its Series A Convertible Preferred Stock (“Preferred Stock”) in a private placement f ...