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• Organogenesis is like a highly specialized Johnson & Johnson, but exclusively creating bioengineered skin and tissue products for complex, chronic wounds.
• Think of it as a biotechnology company, similar to a focused Regeneron, specializing in bioengineered skin and tissue products to heal severe chronic wounds.

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• Apligraf: A living, bilayered cellular product used for the treatment of diabetic foot ulcers and venous leg ulcers.
• Dermagraft: A cryopreserved human fibroblast-derived dermal substitute indicated for the treatment of full-thickness diabetic foot ulcers.
• PuraPly AM: A purified collagen matrix with broad-spectrum antimicrobial properties, designed for various wound types.
• Affinity: A cryopreserved placental allograft used as a protective barrier in chronic and acute wounds.

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Organogenesis (ORGO) primarily sells its products to other companies, specifically healthcare facilities and professionals within the U.S. These customers are the providers who then use Organogenesis's regenerative medicine products to treat patients.

The categories of customer companies that Organogenesis serves include:

• Hospitals
• Wound care centers
• Physician offices
• Ambulatory surgery centers (ASCs)

However, based on the company's latest SEC filings (e.g., its Annual Report on Form 10-K for the fiscal year ended December 31, 2023), Organogenesis has a highly diversified customer base. The company explicitly states that no single customer accounted for more than 10% of its net product revenue for the years ended December 31, 2023, 2022, or 2021. Therefore, Organogenesis does not have any individually identifiable "major customer companies" (whose names could be listed with symbols) that contribute a significant portion of its total revenue.

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Gary S. Gillheeney, Sr., President, Chief Executive Officer and Chair of the Board

Mr. Gillheeney has served as President and Chief Executive Officer of Organogenesis since 2014, and as Chair of the Board since 2023. He joined Organogenesis as Chief Financial Officer and Chief Operating Officer in 2002 and 2003, respectively, and played a key role in the company's growth, including through acquisitions. Prior to Organogenesis, he held executive positions as Chief Operating Officer, Chief Financial Officer, Treasurer, and Secretary at Innovative Clinical Solutions, Ltd. from 1999 to 2002. He also served as Senior Vice President, Chief Financial Officer, Treasurer, and Assistant Secretary at Providence Energy Corporation. He was recognized as an Ernst & Young "Entrepreneur of the Year" in 2009.

David C. Francisco, Chief Financial Officer

Mr. Francisco was appointed Chief Financial Officer of Organogenesis in February 2021. Before joining Organogenesis, he spent 20 years at PerkinElmer, Inc. (NYSE: PKI), where he held various leadership roles. His positions at PerkinElmer included Vice President and Treasurer, Vice President, Investor Relations, Vice President of Financial Operations, and Chief Financial Officer of its Human Health segment. He also previously held treasury and finance roles at Thomson Financial and Ligature, Inc.

Patrick Bilbo, Chief Operating Officer

Mr. Bilbo has served as Chief Operating Officer of Organogenesis since 2017. He previously held various executive positions at Organogenesis from 1999 to 2017, including Senior Vice President, Regulatory, Government Affairs and Administration. His career in regenerative medicine, biotechnology, and medical devices spans over 30 years. Before Organogenesis, he was Director, Regulatory and Clinical Affairs, for Cytyc Corporation (now Hologic Corporation) from 1994 to 1998, and also held management and research positions at Stryker Corporation and Harvard Medical School.

Brian Grow, Chief Commercial Officer

Mr. Grow has served as Chief Commercial Officer of Organogenesis since 2017. He joined the company in 2004 and has held roles of increasing responsibility, including Director of Sales, Commercial Operations, Associate Director, Marketing, Project Manager—Apligraf, Regional Sales Manager, and Tissue Regeneration Specialist. Prior to Organogenesis, he was a pharmaceutical sales representative for Bristol-Myers Squibb and a tissue engineering specialist for Innovex/Novartis.

Lori Freedman, Chief Administrative and Legal Officer

Ms. Freedman has served as Chief Administrative and Legal Officer since 2023. She joined Organogenesis in 2017, serving as Vice President and General Counsel since 2018. Her prior experience includes serving as Vice President, Corporate Affairs & General Counsel of pSivida Corp., a specialty biopharmaceutical company, from 2001 to 2016, and as Vice President, General Counsel for Allaire Corporation, a computer software company, from 1998 to 2001.

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Key Risks to Organogenesis (ORGO)

1. Reimbursement and Regulatory Changes: Organogenesis operates in the healthcare sector, making it highly susceptible to changes in government healthcare programs and private health plan coverage, as well as overall regulatory shifts. Uncertainty and delays in reimbursement policies, particularly from the Centers for Medicare and Medicaid Services (CMS), can significantly impact product adoption, revenue, and profitability. For instance, the company's 2025 guidance was based on specific Local Coverage Determinations (LCDs), and ongoing reimbursement uncertainty has been noted as a market disruptor that is expected to remain challenging into the second half of 2025.
2. Financial Performance and Cash Flow Challenges: Organogenesis has faced profitability challenges, evidenced by negative earnings per share (EPS) and negative EBITDA margins. The company has also reported consistent revenue declines in 2025, alongside substantial negative free cash flow. While the company's debt-to-equity ratio has recently indicated a low level of leverage, the persistent cash flow challenges and financial underperformance pose a significant risk to its operational stability and growth prospects.
3. Intense Industry Competition: The regenerative medicine market, where Organogenesis is a key player, is highly competitive. The introduction of new products by competitors and heightened pricing competition can lead to margin pressures, affect market share, and impact the company's ability to achieve long-term growth.

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Organogenesis (ORGO) operates primarily in two main addressable markets: Advanced Wound Care and Surgical & Sports Medicine.

The total addressable market for Organogenesis's Advanced Wound Care and Surgical & Sports Medicine products was estimated to be approximately $24 billion in 2021, with specific breakdowns as follows:

• Advanced Wound Care: Approximately $10 billion (U.S. and global, with the global market for advanced wound care estimated at $10 billion in 2021 and projected to grow).
• Surgical & Sports Medicine: Approximately $14 billion (U.S.).

Another estimate from 2021 places the combined addressable market for Advanced Wound Care and Surgical & Sports Medicine at approximately $25 billion, comprising $10 billion for Advanced Wound Care and $15 billion for Surgical & Sports Medicine.

For skin substitutes, a key product category for Organogenesis including products like Apligraf and PuraPly AM, internal company estimates indicate that if the potentially addressable market in the United States alone were fully penetrated, annual revenue could exceed $9 billion.

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Organogenesis (ORGO) is expected to drive future revenue growth over the next 2-3 years through several key strategies:

1. Continued Growth in Advanced Wound Care and Surgical & Sports Medicine Products: The company consistently reports strong sales in both its Advanced Wound Care (AWC) and Surgical & Sports Medicine (SSM) segments. AWC products are the primary revenue driver, contributing approximately 94% of total revenue in 2024, and both segments are projected to see continued year-over-year increases in net revenue through 2025. Organogenesis' sales results have been driven by enhanced customer relationships, regained accounts, and the acquisition of new accounts.
2. Favorable CMS Policy Changes and Reimbursement for Skin Substitutes: Recent and anticipated changes in the Centers for Medicare & Medicaid Services (CMS) policies are expected to significantly boost market access and growth. The finalization of skin substitute classifications and a new payment methodology by CMS are seen as positive for the long-term health of the wound care market and are anticipated to enhance Organogenesis' competitive position, especially for its PMA products.
3. New Product Development and Expansion, including the ReNu Program: Organogenesis is focused on expanding its product portfolio and entering new markets. The company highlights the successful launch of several new products and views its ReNu program as a "transformational opportunity" for future growth, particularly within the pain management market, despite a past Phase III trial setback. The reintroduction of products like Dermagraft is also noted as a lever for growth.
4. Leveraging Underpenetrated Market Opportunities and Clinical Validation: Analysts suggest that Organogenesis is well-positioned for growth due to underpenetrated market opportunities in both advanced wound care and surgical markets. The company's strategic focus on clinical validation and securing Medicare reimbursement for its products, including NuShield, PuraPly AM, and PuraPly XT, is expected to drive long-term growth.

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Share Repurchases

• On November 27, 2024, Organogenesis entered into a stock repurchase agreement to buy back 500,000 shares of its Class A common stock at $4.057 per share from the GN 2016 Family Trust, with the transaction expected to close around December 3, 2024.
• This repurchase was approved by the Audit Committee and a Transaction Committee of the Board.
• A portion of the proceeds from the company's sale of Series A Convertible Preferred Stock in November 2024 was used to fund this share repurchase.

Share Issuance

• On November 12, 2024, Organogenesis secured a $130 million private placement through the sale of Series A Convertible Preferred Stock to Avista Healthcare Partners.
• The Preferred Stock is convertible into common stock at $3.79 per share.
• The number of common shares issued increased from 126,458,784 at December 31, 2024, to 127,639,990 at September 30, 2025.

Inbound Investments

• Organogenesis received a $130 million private placement from Avista Healthcare Partners on November 12, 2024, through the sale of Series A Convertible Preferred Stock.
• The net proceeds from this investment are designated for strategic growth initiatives, including operating activities, clinical development, working capital, and debt repayment.
• As part of the investment, Garrett Lustig from Avista Healthcare Partners joined Organogenesis' Board of Directors.

Capital Expenditures

• Organogenesis invests between $1.9 million and $10.7 million per quarter in property, plant, and equipment.
• These investments are aimed at supporting capacity or efficiency.