Organogenesis Holdings Inc. (ORGO) SEC Filings & Earnings Calls

Severe revenue decline of 58% YoY, with Advanced Wound Care down 61%.

“Net revenue $42.8M vs $100.8M; Advanced Wound Care $36.1M vs $92.7M.”

Gross margin collapsed from 73% to 45%, indicating significant pricing or cost pressure.

“Gross profit margin 45% vs 73%.”

Net loss widened to $96.3M from $9.4M, with Adjusted EBITDA loss of $34.4M.

“Net loss $96.3M vs $9.4M; Adjusted EBITDA loss $34.4M vs $3.6M.”

Potential dilution from up to $75M equity offering.

“Shares having an aggregate offering price of up to $75,000,000.” · word for word

Medicare reimbursement dependency

“we experienced a significant year-over-year decline in revenue in the first and second quarters of fiscal year 2026, and we are continuing to experience a significant year-over-year decline in revenue in the third quarter of fiscal year 2026” · word for word

Market disruption and clinician confusion

“continued clinician confusion and material disruption in the market following the withdrawal of the LCD coverage policies for skin substitutes and CMS published comments regarding discarded product in December 2025” · word for word

Dermagraft relaunch delay

“given the decline in the skin substitute market and the decline in our net revenue we are delaying the relaunch of Dermagraft and cannot currently project specific timing” · word for word

Medicare reimbursement dependency

“The decrease in net product revenue in the three months ended March 31, 2026 was primarily due to a decrease in Advanced Wound Care net product revenue attributable to increased clinician confusion and material disruption in the market following the withdrawal of the LCD coverage policies for skin substitutes and CMS published comments regarding discarded pr” · word for word

Going concern risk from negative EBITDA

“Adjusted EBITDA $ (48,150) for three months ended March 31, 2026.”

Revolving facility expiration

“As of December 31, 2025 and March 31, 2026, we did not have outstanding borrowings under our Revolving Facility, which will expire on August 6, 2026.” · word for word

Severe revenue decline and margin collapse threaten viability; cash burn rate high.

“Revenue down 58%, gross margin 29%, net loss $53.2M, adjusted EBITDA loss $48.2M.”

Gross margin pressure

“Gross Margin: Minimum (75% Payout) 76.5%, Target (100% Payout) 77.3%, Maximum (200% Payout) 79.3%, Actual Result 76.4%, Metric Attainment (%) 0%”

Key person dependency

“CEO pay ratio 17:1; significant retention awards not disclosed in this filing.”

CMS payment reform for skin substitutes expected to cause market disruption and impact H1 2026 results.

“While we expect the first half of 2026 to be impacted by the market adapting to the sweeping changes from CMS to reform coverage and payment for skin substitutes” · word for word

Surgical & Sports Medicine segment showed slight revenue decline (-2% YoY), indicating potential weakness.

“Net product revenue from Surgical & Sports Medicine products of $7.9 million, a decrease of 2% from the fourth quarter of 2024” · word for word

Product liability claims

“We face the risk of product liability claims and may not be able to obtain or maintain adequate product liability insurance.” · word for word

Supply chain disruption

“Interruptions in the supply of our products or inventory loss may adversely affect our business, results of operations, and financial condition.” · word for word

Regulatory classification risk

“The FDA may determine that certain of our products that are, or are derived from, human cells or tissues, such as Affinity, Novachor, and NuShield, do not qualify for regulation solely under Section 361 of the Public Health Services Act, or PHSA.” · word for word

Clinical trial failure

“This second Phase 3 RCT of ReNu did not achieve statistical significance for its primary endpoint, despite results demonstrating a numerical improvement in baseline pain reduction over the first Phase 3 trial.” · word for word

Impairment risk

“We incurred non-cash impairment and write-down charges during 2025 and 2024 which adversely affected our fiscal year 2025 and 2024 operating results and we may be required to incur additional future impairment and write-down charges, which could adversely affect our operating results.” · word for word

Related party transactions may raise governance concerns.

“Lease amendments involve entities owned by holders of 5%+ of stock and board members.”

Reimbursement Risk

“more than 200 products would be classified as 'non-covered,' including our PuraPly, PuraPly AM, PuraPly XT, Novachor, TransCyte, Dual and Matrix products for DFUs and VLUs” · word for word

Clinical Trial Failure

“This second Phase 3 RCT of ReNu did not achieve statistical significance for its primary endpoint” · word for word

Revenue Concentration

“Advanced Wound Care products accounted for 94% of net product revenue in Q3 2025”

Negative Operating Cash Flow

“Net cash used in operating activities was $49.7 million” · word for word

Dependence on CMS payment rule for future growth; regulatory changes could impact

“In light of the recently announced CMS payment rule, I believe we are well-positioned in 2026 and beyond” · word for word