Financial Data and Key Metrics Changes - Net income for Q4 2022 was $7.5 million, a decrease of $43.5 million compared to $51 million in Q4 2021, primarily due to a prior year tax benefit of $32 million [2] - Adjusted EBITDA for Q4 2022 was $14.1 million, or 12% of net revenue, down from $26.3 million, or 21% of net revenue, in the previous year [2] - Operating income for Q4 2022 was $8.7 million, a decrease from $19.8 million in the prior year [67] Business Line Data and Key Metrics Changes - Net revenue for Advanced Wound Care products in Q4 2022 was $108.8 million, down 10% year-over-year, while Surgical & Sports Medicine products revenue was $6.7 million, down 6% [21][29] - PuraPly products generated $56.8 million in revenue for Q4 2022, a decline of 9% [29] - Excluding certain products, there was low double-digit growth in the number of accounts served in both hospital outpatient and physician office settings [23] Market Data and Key Metrics Changes - The company experienced a 10% decline in sales of non-PuraPly products due to reimbursement uncertainty and competitive pressures [22] - The company expects sales of non-PuraPly products to increase approximately 28% year-over-year in 2023 [3][73] Company Strategy and Development Direction - The company is in the second year of a strategic repositioning, focusing on expanding its commercial reach beyond spine fusion and foot and ankle procedures [5] - The company aims to strengthen its competitive position in the surgical sports medicine market and enhance its product offerings [34][71] - The company plans to optimize independent agency relationships and pilot new commercial strategies [5] Management's Comments on Operating Environment and Future Outlook - Management acknowledged a challenging operating environment in Q4 2022, with expectations for continued competitive noise in 2023 [70] - The company remains confident in its long-term growth potential, targeting sustainable low double-digit growth on a normalized basis [71] - Management expects to navigate challenges in the office setting due to competitive pressures but anticipates stable growth in wound care centers and hospital outpatient settings [52][70] Other Important Information - The company has paused construction of its Canton manufacturing facility due to increased costs, with a 40% rise in estimated project investment [26] - The company has $103.3 million in cash and cash equivalents and $70.8 million in debt obligations as of December 31, 2022 [31] Q&A Session Summary Question: What are the assumptions underpinning the guidance from a macro perspective? - Management acknowledged competitive noise but indicated expectations for market growth in 2023 [6] Question: Why has PuraPly seen drastic declines in usage for 2023? - Management noted a pause in acquisition due to the publication of the physician fee schedule, which is expected to improve over time [7] Question: Can you elaborate on potential rebates from CMS? - Management indicated uncertainty regarding potential refund amounts owed to CMS [8][57] Question: What is the outlook for competitive pressures? - Management believes competitive pressures may improve as the market absorbs new product information and efficacy becomes a key differentiator [12][62]

Financial Performance - For the year ended December 31, 2022, Organogenesis generated revenue of $450.9 million and incurred operating expenses of $323.6 million[20]. - The company reported net income of $15.5 million, $94.2 million, and $17.2 million for the fiscal years 2022, 2021, and 2020, respectively, but has incurred significant losses in many years since inception, with an accumulated deficit of $45.3 million as of December 31, 2022[204]. - The company expects to incur significant sales and marketing costs to support product sales, impacting future profitability[204]. - The company reported that reimbursement rates for its products have been unstable and unpredictable, which could adversely affect its financial condition[196]. Market Opportunity - The addressable Advanced Wound Care and Surgical & Sports Medicine markets totaled approximately $24 billion in 2021, with an estimated $10 billion for Advanced Wound Care and $14 billion for Surgical & Sports Medicine[26]. - The immediate addressable Surgical & Sports Medicine market is estimated at approximately $14 billion, with a CAGR of about 6% through 2028[41]. - The addressable market for skin substitutes in the U.S. could exceed $9 billion if fully penetrated, highlighting significant growth potential[39]. - The worldwide wound biologics market was estimated at approximately $1.7 billion in 2021, with skin substitutes representing about 62% of this market[36]. Product Portfolio and Development - Organogenesis has a comprehensive portfolio of products, including Apligraf and Dermagraft, which have received FDA approvals, providing a strong competitive advantage[17]. - The advanced wound care product suite includes various offerings such as Affinity, Novachor, Apligraf, and Dermagraft, targeting chronic and acute wounds[56]. - The company has established a robust pipeline of products expected to launch in the coming years, enhancing its market offerings[27]. - The company has a robust product pipeline, including line extensions for PuraPly and PuraPly AM, aimed at addressing additional clinical applications[70]. Clinical Efficacy and Studies - Apligraf achieved a 56% complete wound closure rate for diabetic foot ulcers by 12 weeks, compared to 38% for conventional therapy (p=0.0042) with a median time to closure of 65 days[93]. - Apligraf demonstrated a 57% closure rate by week 24 for venous leg ulcers, compared to 40% for the control group (p=0.022)[98]. - PuraPly AM demonstrated wound closure rates of 52%, 62%, and 73% at weeks 20, 26, and 32 respectively, with a median time to closure of 17 weeks across 307 patients[81]. - ReNu treatment for knee osteoarthritis resulted in a statistically significant reduction in pain compared to hyaluronic acid and saline at 12 months follow-up[86]. Regulatory and Compliance - The company is currently evaluating regulatory pathways and market potential for products in major markets, including the European Union[115]. - Medicare coverage for the company's products is determined by each MAC for its specific jurisdiction, with all MACs currently covering the products in outpatient settings[125]. - The FDA regulates the manufacturing processes, requiring compliance with Quality System Regulation (QSR) for medical device products[158]. - The company must comply with medical device reporting regulations, including reporting serious injuries or malfunctions to the FDA[161]. Competitive Landscape - The company competes in a highly competitive market with several key competitors, including Amniox Medical, Inc. and Smith & Nephew plc, focusing on product efficacy and customer support[149]. - The company relies on a combination of intellectual property protections, including patents and trademarks, to maintain its competitive position in the market[152]. - The company emphasizes the importance of timely development and regulatory approval for new products to meet market demand, as delays could negatively impact operational results[211]. Employee and Organizational Culture - The company has approximately 1,030 employees worldwide as of December 31, 2022, with no employees represented by a collective bargaining agreement[191]. - The company has not raised employee contributions to healthcare benefits for 7 years running, indicating a commitment to employee welfare[192]. - The company aims to maintain an "open door" culture to encourage employee feedback and foster a respectful working environment[192]. - The company prioritizes employee health and safety through various programs and a dedicated Environmental Health & Safety team[193]. Risks and Challenges - The company faces potential adverse effects on its business if Medicare finalizes policies that limit reimbursement for skin substitutes in 2024 or 2025[196]. - The company has identified material weaknesses in its internal control over financial reporting, which could lead to inaccurate financial reporting and loss of investor confidence[205][207]. - The company is dependent on a limited group of suppliers for its products, which poses risks of significant product development costs or delivery delays[201]. - The company may face significant competition that could adversely affect its business and financial condition[201].

Financial Data and Key Metrics Changes - The company reported net revenue of $116.9 million for Q3 2022, a 3% increase year-over-year, driven by a 2% increase in advanced wound care products and a 15% increase in surgical and sports medicine products [7][33] - Gross profit for Q3 2022 was $90.7 million, approximately 77.6% of net revenue, compared to 77% in the previous year [34] - Operating income decreased to $1.8 million from $16.3 million year-over-year, while net income fell to $0.2 million from $12.6 million [39][40] - Adjusted EBITDA for Q3 2022 was $11.6 million, or 10% of net revenue, down from $21.7 million, or 19% of net revenue, in the prior year [40] Business Line Data and Key Metrics Changes - Advanced wound care net revenue was $109.5 million, up 2% year-over-year, while surgical and sports medicine products generated $7.3 million, up 15% [33] - Sales of PuraPly products increased by 12% year-over-year, contributing $63.7 million to net revenue [34][33] - Non-PuraPly product sales declined by 6% year-over-year, primarily due to a 21% decline in PMA and other products [15][16] Market Data and Key Metrics Changes - The company experienced a challenging operating environment in the physician office setting, impacted by competitive pressures and staffing challenges [9][10] - The hurricane Ian affected demand in Florida during the last week of the quarter, which contributed to lower sales results [8] - The company anticipates continued competitive pressure in the amniotic products market until CMS publishes ASPs [21][22] Company Strategy and Development Direction - The company aims to diversify revenue across physician specialties and sites of care, targeting product development and commercial strategies to drive growth [12] - The company paused the construction of a manufacturing facility in Canton, Massachusetts, due to a 40% increase in expected investment costs [24][25] - The company plans to continue launching innovative products and expanding its sales force to enhance market penetration [23][11] Management's Comments on Operating Environment and Future Outlook - Management noted that competitive pressures and reimbursement confusion are significant challenges, particularly in the office setting [52][58] - The company updated its full-year 2022 guidance, expecting net revenue between $448 million and $465 million, reflecting a decline of approximately 2% year-over-year [20][43] - Management expressed confidence in the company's unique value proposition and broad product portfolio to navigate current challenges [22][23] Other Important Information - The company is progressing in its Phase 3 clinical trial for ReNu for knee osteoarthritis, with over 82% of patients enrolled [27] - The company plans to submit an IND amendment to the FDA and expects to launch a second Phase 3 trial by mid-2023 [28] Q&A Session Summary Question: What factors contributed to the decline in the amnion business? - Management indicated that competitive pressure and confusion regarding reimbursement have persisted, impacting sales [52] Question: Any updates on Novachor and its impact on TransCyte? - Novachor is currently in a soft launch phase, with expectations for a more significant impact next year. Alternatives for TransCyte manufacturing are being explored [54] Question: How do the recent challenges affect the fourth quarter outlook? - Management acknowledged that the hurricane and competitive pressures impacted sales, but they expect to remain at the lower end of guidance [57] Question: What is the expectation for pricing strategies moving forward? - Management confirmed that pricing has been affected by competition, and they are focused on understanding account dynamics to navigate the situation [61] Question: What are the expectations for growth in 2023? - Management refrained from providing specific guidance for 2023 but noted that a larger sales force and new products should positively impact growth [64] Question: How will the company manage costs in the upcoming year? - Management emphasized a prudent investment approach based on revenue outlook while maintaining strong fundamentals [66]

Financial Performance - For the nine months ended September 30, 2022, the company generated $335.4 million in net revenue, a decrease of 1.3% from $339.5 million in the same period of 2021[114]. - The net income for the nine months ended September 30, 2022, was $8.0 million, down from $43.2 million in the prior year, reflecting a significant decline[114]. - The company reported a gross profit of $257.5 million for the nine months ended September 30, 2022, compared to $257.9 million for the same period in 2021, showing a slight decrease[132]. - Net income for the three months ended September 30, 2022, was $0.215 million, a significant decrease from $12.577 million in the same period in 2021[134]. - Adjusted EBITDA for the three months ended September 30, 2022, was $11.605 million, compared to $21.650 million in the same period in 2021, reflecting a decline of 46.3%[134]. - Net revenue for the three months ended September 30, 2022, was $116.859 million, a 3% increase from $113.753 million in the same period in 2021[136]. - Advanced Wound Care products generated net revenue of $109.514 million in the three months ended September 30, 2022, up 2% from $107.341 million in 2021[136]. - Surgical & Sports Medicine products saw a revenue increase of 15% to $7.345 million in the three months ended September 30, 2022, compared to $6.412 million in 2021[137]. - Net revenue from PuraPly products was $63.7 million for the three months ended September 30, 2022, up from $57.0 million in the same period in 2021[138]. Expenses - Selling, general and administrative expenses increased to $215.5 million for the nine months ended September 30, 2022, up from $182.9 million in 2021, reflecting increased investments in market development[132]. - Research and development expenses rose to $28.4 million for the nine months ended September 30, 2022, compared to $22.5 million in the prior year, indicating a focus on product development[132]. - Research and development expenses rose by 7% to $9.575 million in the three months ended September 30, 2022, from $8.953 million in 2021[141]. - Selling, general and administrative expenses increased by 27% to $79.328 million in the three months ended September 30, 2022, from $62.369 million in 2021[142]. Cash Flow and Capital Expenditures - Net cash provided by operating activities was $17.1 million for the nine months ended September 30, 2022, compared to $44.0 million for the same period in 2021[151]. - During the nine months ended September 30, 2022, the company used $23.2 million in cash for capital expenditures[154]. - The company expects that its cash on hand and working capital will be sufficient to fund operating expenses and capital expenditures for at least 12 months beyond the filing date of the quarterly report[147]. Debt and Borrowings - As of September 30, 2022, the company had outstanding borrowings of $73.1 million under the Term Loan Facility of the 2021 Credit Agreement[162]. - The 2021 Credit Agreement provides for a term loan facility not to exceed $75.0 million and a revolving credit facility not to exceed $125.0 million[157]. - As of September 30, 2022, the company had $73.1 million in borrowings outstanding under its term loan facility[170]. - There were no borrowings outstanding under the revolving credit facility as of the same date[170]. - Borrowings under both facilities bear interest at variable rates, with a 10% change in interest rates having no material impact on debt obligations or financial position[170]. Financial Position - As of September 30, 2022, the company had an accumulated deficit of $52.8 million, indicating ongoing financial challenges since inception[114]. - As of September 30, 2022, the company had working capital of $141.3 million, including $107.3 million in cash and cash equivalents[147]. Market and Operational Risks - The company continues to monitor the impact of COVID-19 on its operations, although it has not materially affected financial results through September 30, 2022[115]. - The majority of the company's operations are located in the United States, with minimal exposure to foreign currency fluctuations[171]. - The functional currency of the Swiss subsidiary is the U.S. dollar, indicating limited foreign currency risk[171]. - The company has engaged in contracts with vendors in currencies other than the U.S. dollar, but the exposure has been minimal due to short transaction durations[171]. - Established policies and procedures are in place for managing market risk and financial instruments[168]. - The company is primarily exposed to interest rate risk and currency exchange rate variability[168]. - Overall, the company believes it does not have a material exposure to foreign currency risk[171]. - The management of market risk is governed by internal processes established by the company[168]. Strategic Initiatives - The company plans to transition Dermagraft manufacturing to Massachusetts, which is expected to result in substantial long-term cost savings[118]. - The company is focusing on clinical development of ReNu for knee osteoarthritis treatment, having discontinued clinical development of NuCel[117].

Organogenesis Holdings Inc. (NASDAQ:ORGO) Q2 2022 Earnings Conference Call August 9, 2022 5:00 PM ET Company Participants Gary Gillheeney - President and Chief Executive Officer Dave Francisco - Chief Financial Officer Conference Call Participants Steve Lichtman - Oppenheimer Ryan Zimmerman - BTIG Operator Good afternoon, ladies and gentlemen, and welcome to the Second Quarter 2022 Earnings Conference Call for Organogenesis Holdings Inc. At this time, all participants have been placed in a listen-only mode. ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended June 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number 001-37906 ORGANOGENESIS HOLDINGS INC. (Exact Name of Registrant as Specified in Its Charter) Delaware 98-1329150 (State or Other Jurisdiction of Incorp ...

Financial Data and Key Metrics Changes - The company reported net revenue of $98.1 million for Q1 2022, a decrease of 4% year-over-year, primarily due to flat growth in Advanced Wound Care products and a 39% decline in Surgical & Sports Medicine products [8][26] - Adjusted net revenue, excluding ReNu and NuCel, increased by 1% year-over-year [9][26] - Gross profit for Q1 2022 was $73 million, approximately 74% of revenue, compared to 75% in the previous year [27] - Operating income decreased to $0.9 million from $12.6 million year-over-year [31] - Net income for Q1 2022 was $0.1 million, down from $9.9 million in the prior year [32] Business Line Data and Key Metrics Changes - Advanced Wound Care net revenue was $91 million, essentially flat year-over-year [26] - Surgical & Sports Medicine products generated $7.2 million in revenue, down 39% due to the suspension of ReNu and NuCel marketing [26] - PuraPly products saw a 29% increase in sales year-over-year, reaching $53.3 million [27][12] - Amniotic products experienced a 32% decline year-over-year, reflecting the impact of Omicron on the national launch of Affinity [12] Market Data and Key Metrics Changes - The overall operating environment in Q1 was impacted by rising Omicron case counts, affecting patient consultations and elective procedures [15] - The company expects steady improvement in the operating environment as COVID-related headwinds diminish throughout 2022 [16] Company Strategy and Development Direction - The company aims to diversify revenue across physician specialties and sites of care through targeted product development and commercial strategies [14] - The midpoint of the full-year revenue range assumes amniotic growth of approximately 12% year-over-year in 2022 [13] - The company plans to launch new products and line extensions to drive demand and expand market presence [10] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the full-year 2022 guidance, expecting net revenue between $485 million and $515 million, representing growth of 4% to 10% year-over-year [17][34] - The company anticipates stronger growth trends in the second half of 2022, driven by new product contributions and a return to a normalized operating environment [17][34] Other Important Information - The company appointed Michele Korfin and Gilberto Quintero to the Board of Directors, enhancing the board's experience and diversity [23][24] - The company is making progress in its Phase III clinical trial of ReNu for knee osteoarthritis, with enrollment on track [21] Q&A Session Summary Question: Update on amniotic product line and Affinity - Management noted that Q1 performance for Affinity was as expected, with positive trends observed in recent weeks and confidence in continued expansion throughout the year [45] Question: Update on commercial organization growth - The company plans to add approximately 50 new direct sales representatives and is evaluating agency relationships for competency [51] Question: Medicare pricing expectations - Management indicated that pricing changes would be reflected in the average selling price (ASP) as they occur, but no specific pricing strategy was discussed [60] Question: Restructuring program and gross margins - The restructuring aims to increase capacity and efficiency, with expectations for gross margins to improve as revenue increases throughout the year [63]

Table of Contents ORGANOGENESIS HOLDINGS INC. UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended March 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number: 001-37906 (Exact Name of Registrant as Specified in Its Charter) Delaware 98-1329150 (State or Other Jurisdiction of (I.R ...

Organogenesis Empowering Healing Oppenheimer Annual Healthcare Conference 3/15/22 Organogenesis Empowering Healing 2 Forward Looking Statements and Other Important Cautions This presentation 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," "anticipa ...

Organogenesis Holdings Inc. (NASDAQ:ORGO) Q4 2021 Earnings Conference Call March 1, 2022 5:00 PM ET Company Participants Gary Gillheeney - President and Chief Executive Officer Dave Francisco - Chief Financial Officer Conference Call Participants Ryan Zimmerman - BTIG Danielle Antalffy - SVB Leerink Steven Lichtman - Oppenheimer Operator Good afternoon, ladies and gentlemen and welcome to the Fourth Quarter 2021 Earnings Conference Call for Organogenesis Holdings Inc. [Operator Instructions] Please note tha ...