Organogenesis (ORGO) Q3 2026 Earnings Call Transcript

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DATE

Thursday, Nov. 5, 2026

CALL PARTICIPANTS

• President, Chief Executive Officer, and Chair of the Board - Gary S. Gillheeney Sr.
• Chief Financial Officer - Dave Francisco.

TAKEAWAYS

• Net Product Revenue -- $45.5 million, representing a 70% decrease year over year driven by market contraction following the withdrawal of Local Coverage Determination policies.
• Advanced Wound Care Revenue -- $38.2 million, declining 73% year over year due to payment policy changes and clinician confusion regarding discarded product rules.
• Surgical & Sports Medicine Revenue -- $7.3 million, falling 19% year over year during the three-month period.
• Sequential Revenue Growth -- 6% increase compared to the second quarter of 2026, reflecting improving clinician clarity and product utilization.
• Gross Profit Margin -- 52%, down from 76% in the prior year, impacted by lower revenue scale and inventory write-downs.
• GAAP Operating Expenses -- $75.0 million, a 42% reduction year over year following restructuring activities and cost-control initiatives.
• Annualized Cost Savings -- $45.0 million, including $32.0 million related to restructuring and $8.5 million in headcount savings within cost of goods sold.
• GAAP Net Loss -- $29.6 million, compared to a net income of $21.6 million in the prior year.
• Cash and Equivalents -- $26.9 million as of Sept. 30, 2026, down from $94.3 million at the end of 2025.
• Full Year 2026 Revenue Guidance -- $179.4 million to $200.0 million, indicating an annual decline of 65% to 68%.
• Advanced Wound Care Guidance -- $151.0 million to $171.0 million for the full year 2026.
• Surgical & Sports Medicine Guidance -- $26.0 million to $27.0 million for the full year 2026.
• Grant Income Guidance -- $1.9 million for the full year 2026, providing supplemental non-product revenue.
• Adjusted EBITDA Loss Reduction -- 60% to 80% reduction targeted for the second half of 2026 compared to the first half of the year.
• Amnuvx Remediation Cost -- $8.0 million total, with $4.0 million representing incremental spending and $4.0 million in pulled-forward capital improvements.
• Market Share -- 30% increase achieved since the first quarter of 2026, outperforming major established competitive portfolios.
• Competitor Inventory Impact -- 20% of skin substitute sales in the third quarter were estimated to originate from inventory liquidations by companies exiting the market.
• FDA Remediation Items -- 18 items identified at the Norwood facility following a pre-license inspection, requiring facility upgrades.
• PDUFA Target Date Extension -- The regulatory review timeline for Amnuvx has been extended from April 24, 2027, to accommodate remediation work.
• Liquidity Outlook -- Management stated that current cash on hand and net cash flows from product sales are sufficient to fund operations for at least 12 months.

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RISKS

• Gillheeney stated, "the uncertainty around comments on discarded product has created real confusion for our customers, particularly around Apligraf," contributing to the market contraction.
• Gillheeney noted that the FDA "identified 18 items requiring remediation" at the Norwood facility, which will extend the regulatory review timeline for Amnuvx.

SUMMARY

Organogenesis Holdings Inc. (NASDAQ:ORGO) reported a significant decline in quarterly revenue compared to the prior year, primarily attributed to shifts in Medicare reimbursement policies and market confusion regarding discarded product rules. Management indicated that the skin substitute market has likely bottomed out, with sequential revenue growth and broad-based market share gains across its product portfolio. The company has implemented substantial restructuring measures to reduce its operating expense profile and is prioritizing clinical evidence to differentiate its biologic offerings from competitors. While regulatory delays for the Amnuvx program have extended the development timeline, the company remains focused on securing a Biologics License Application for the knee osteoarthritis treatment.

• Management reported ongoing constructive engagement with federal policymakers regarding the distinct manufacturing and administration requirements of living cell-based therapies.
• The company is evaluating alternative financing strategies to fund capacity enhancements at the Smithfield facility and support future commercialization efforts.
• CEO Gillheeney stated, "As coverage policies evolve, evidence will be the currency of credibility, and we intend to remain in the lead."
• Management expects the competitive landscape to narrow to four or five major players with quality products as companies without comparable clinical evidence exit the wound care market.
• The Amnuvx program aims to address a treatment gap for more than 30 million Americans living with symptomatic knee osteoarthritis who lack disease-directed nonsurgical options.

INDUSTRY GLOSSARY

• Amnuvx: A biologic therapy for knee osteoarthritis, formerly known as the ReNu program, currently under FDA review.
• BLA: Biologics License Application, a request for permission to introduce a biologic product into interstate commerce.
• CMS: Centers for Medicare & Medicaid Services, the federal agency that administers the Medicare program.
• DFU: Diabetic Foot Ulcer, a common and difficult-to-treat complication of diabetes.
• ECM: Extracellular Matrix, a network of molecules that provide structural and biochemical support to surrounding cells.
• LCD: Local Coverage Determination, a decision by a Medicare Administrative Contractor on whether a service or item is reasonable and necessary.
• PDUFA: Prescription Drug User Fee Act, which establishes target dates for the FDA to complete reviews of drug applications.
• PMA: Premarket Approval, the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices.

Full Conference Call Transcript

Operator: Welcome, ladies and gentlemen, to the third quarter 2026 earnings conference call for Organogenesis Holdings Inc. At this time, all participants have been placed in listen-only mode. Please note that this conference call is being recorded and that the recording will be available on the company's website for replay shortly.

Before we begin, I would like to remind everyone that our remarks today may contain forward-looking statements that are based on the current expectations of management and involve inherent risks and uncertainties that could cause actual results to differ materially from those indicated, including the risks and uncertainties described in the company's filings with the Securities and Exchange Commission, including Item 1A, Risk Factors, of the company's most recent annual report and its subsequently filed quarterly reports. You are cautioned not to place undue reliance upon any forward-looking statements, which speak only as of the date made.

Although it may voluntarily do so from time to time, the company undertakes no commitment to update or revise the forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by applicable securities laws. This call will also include references to certain financial measures that are not calculated in accordance with generally accepted accounting principles, or GAAP. We generally refer to those as non-GAAP financial measures. Reconciliations of those non-GAAP financial measures to the most comparable measures calculated and presented in accordance with GAAP are available in the earnings press release on the investor relations portion of our website. I would now like to turn the call over to Mr. Gary S.

Gillheeney Sr., Organogenesis Holdings President, Chief Executive Officer, and Chair of the Board. Please go ahead, sir.

Gary Gillheeney Sr.: Thank you, operator, and welcome everyone to Organogenesis Holdings third quarter 2026 earnings conference call. I am joined on the call today by Dave Francisco, our Chief Financial Officer. Let me start with a brief agenda of what we will cover during our prepared remarks. I will begin with a brief review of our results and key developments in the third quarter and in recent months. Dave will then provide you with an in-depth review of our third quarter financial results, our balance sheet and financial condition at quarter end, as well as our financial outlook for 2026, which we updated in our press release this afternoon.

I will then provide you some closing comments before we open up the call for your questions. Beginning with a review of our results and key developments in Q3, our revenue results reflect the significant contraction and slow pace of recovery in the skin substitute market following the withdrawal of the LCD coverage policies for skin substitutes and CMS's published comments regarding discarded product in December of 2025. On balance, we were encouraged to see the operating environment improve from what we experienced during the second quarter, particularly as it relates to improving clinician confusion. Although net product revenue declined 70% year-over-year in the third quarter, our net product revenue increased 6% quarter-over-quarter in Q3.

As a leader in the industry, we leveraged our most comprehensive portfolio across multiple FDA classifications, specifically the only biologic PMA-approved product, Apligraf, to enhance our market share position with an increase in volume on a quarter-over-quarter basis, outperforming the declines that have been reported across the industry. As discussed on our second quarter conference call, the competitive landscape has changed dramatically in the months following CMS's sweeping changes to payment policy. Distributor-driven competitors, high-priced amniotic players, and companies engaged in fraudulent practices have been substantially reduced. Many of the remaining players are diversifying away from wound care or exiting the category altogether.

In this new market, customers are deciding which products and which partners they can trust, and they are deciding based on efficacy, outcomes, and evidence. That is the foundation Organogenesis was built on and the primary driver of the continued growth in market share we are achieving this year. These gains are broad-based, with Apligraf, PuraPly AM, Affinity, and NuShield all demonstrating meaningful improvement. That breadth tells us that customers are placing their confidence in our portfolio, not just a single product. We are also treating more patients, and utilization of our skin substitutes is increasing. Our team's commitment to our customers and their patients is paying dividends.

Claims data analysis further supports the fact that Organogenesis is gaining market share, with our share increasing more than 30% versus Q1 and increasing at a rate more than double the major established competitive portfolios. While this growth is more measured than we contemplated in our guidance at the beginning of 2026, we are strengthening our position as this market reshapes. I want to make it clear that I remain very optimistic about our future.

With more than 40 years in regenerative medicine and the most diverse evidence-based portfolio with technologies in each FDA category, we believe we are best positioned in the skin substitute market and will continue to be a leader in the space with the best evidence-based portfolio in the market. It is from this strong long-term market position that we are making important strategic decisions and prioritizing our investments that will support our company's future growth and continued leadership in this market. We are increasing our focus on clinical evidence with new published studies because science and evidence have always been core to our foundation.

As coverage policies evolve, evidence will be the currency of credibility, and we intend to remain in the lead. We continue to advance our strategic initiative to expand the company's mission into entirely new markets with the Amnuvx program. Let me share a few updates on our progress in each of these important strategic initiatives in recent months. on October 12th, we announced the publication of previously released results from PREPARE, a prospective multicenter randomized controlled trial evaluating the safety and efficacy of PuraPly AM in the management of non-healing diabetic foot ulcers, or DFU.

The trial achieved its primary endpoints, and the results published in the Journal of Wound Care demonstrate statistically significant improvements in wound closure at 12 weeks among patients treated with PuraPly AM plus standard of care, providing clinical evidence supporting the use of PuraPly AM in one of the most costly and difficult to treat chronic wound populations. We believe publications of these impactful results will strongly support PuraPly AM's inclusion in any future coverage policies, underscoring its critical role in the wound healing algorithm. We have built a significant body of evidence on the clinical benefit of PuraPly AM, including publications on comparative effectiveness research and a prospective analysis of a large patient registry.

Together, this compelling evidence spans more than 23,000 patients studied, reflecting both the primary and supporting data CMS considers when making coverage determination. Payor review data continues to differentiate Organogenesis in a recalibrated market, where we are gaining share while competitors without comparable evidence are pivoting away from wound care or exiting the market altogether. Turning to an update on our Amnuvx program. Amnuvx, formerly ReNu program, is our initiative to bring a new regenerative therapy intended to meaningfully change the treatment paradigm for knee osteoarthritis. Knee OA is a leading cause of chronic pain, functional impairment, disability, and reduced quality of life. Unfortunately, this patient population progresses through temporary measures until the only option is a total knee replacement.

No biologic therapy for knee OA pain has been approved by the FDA, leaving no disease-directed option between conventional injections and joint replacement. If approved, Amnuvx will establish a new market category for a biologic product that addresses this massive treatment gap for more than 30 million Americans living with symptomatic knee osteoarthritis. We believe this highly differentiated regenerative therapy has the potential to meaningfully change the treatment paradigm by offering a non-surgical biologic option designed to address pain and improve function, particularly for patients with severe disease who lack approved non-surgical options. We completed the BLA submission for Amnuvx with the FDA in April of this year. in June of this year, the FDA accepted the BLA for review.

During the third quarter, the FDA completed a pre-license inspection of our Norwood facility and identified 18 items requiring remediation. In addition, we received information requests from the FDA related to the clinical data we submitted in the BLA following a mid-cycle communication teleconference. We are preparing responses to the information request and currently expect to complete the identified remediation work in the Norwood facility by September 30th, 2027. Accordingly, the PDUFA target date will be extended from April 24th, 2027. While the timeline has been extended, our commitment to pursuing a BLA for this unique non-surgical single injection biologic is unchanged.

We have well-established leading capability to manufacturing the living technology, and therefore are confident that we will resolve the identified observations, and we look forward to continuing engagement with the FDA as we complete their review. With that, let me turn the call over to Dave.

Dave Francisco: Thanks, Gary. I'll begin with a review of our third quarter financial results. Unless otherwise specified, all growth rates referenced during my prepared remarks are for the three-month period ending September 30th, 2026, and are on a year-over-year basis. Net product revenue was $45.5 million, down 70%. Our Advanced Wound Care net product revenue was $38.2 million, down 73%. Net product from Surgical & Sports Medicine products was $7.3 million, down 19%. Importantly, our third quarter results reflect an encouraging improvement in growth trends on a sequential basis. Specifically, our total revenue increased 6% quarter-over-quarter, driven by a 6% increase in sales of Advanced Wound Care products and a 10% increase in sales of our Surgical & Sports Medicine products.

Gross profit was $23.6 million, or 52% of net product revenue, compared to 76% last year. Operating expenses were $75 million compared to $130.1 million last year, a decrease of $55.2 million, or 42%. Excluding cost of goods sold of $21.9 million in Q3 and $36.3 million in last year, our non-GAAP operating expenses were $53 million compared to $93.9 million last year, a decrease of $41 million, or 44%. The year-over-year change in operating expenses, excluding cost of goods sold, was driven by a $34.7 million, or 43% decrease in SG&A expenses, and a $5.3 million, or 40% decrease in research and development expenses.

Operating loss was $29.5 million compared to operating income of $20.7 million last year, a decrease of $50.2 million. GAAP net loss was $29.6 million compared to net income of $21.6 million last year. Net loss to common stockholders was $32.7 million compared to net income of $14.5 million last year. Net loss to common stockholders includes the impact of the cumulative dividend and the non-cash accretion to redemption value of our convertible preferred stock. Adjusted net loss was $29.3 million compared to adjusted net income of $23.2 million last year. Adjusted EBITDA loss was $22.4 million compared to adjusted EBITDA of $30.1 million last year.

We have included a detailed reconciliation of GAAP to non-GAAP adjusted net loss and adjusted EBITDA loss in our press release this afternoon. Turning to the balance sheet, as of September 30th, 2026, the company had $26.9 million in cash equivalents, and restricted cash, and no outstanding debt obligations, compared to $94.3 million in cash equivalents, and restricted cash, and no outstanding debt obligations as of December 31st, 2025. We expect that our cash on hand and other components of working capital as of September 30th, 2026, plus net cash flows from product sales, will be sufficient to fund our operating expenses and capital expenditure requirements for at least the next 12 months.

We continue to evaluate alternative financing strategies to accelerate key investments, including Amnuvx commercialization and enhancing capacity and efficiencies from our Smithfield facility. Turning to our 2026 outlook, which we've updated in this afternoon's press release. While our 2026 outlook continues to reflect the expectation that we see sequential improvement in our revenue trends in the third and fourth quarters, our updated total revenue range now reflects the expectation that we see a more measured recovery in the overall operating environment in the second half of 2026.

We now expect total net revenue for the full year of 2026 of $179 million-$200 million, representing a decline in the range of 65%-68% year over year, and compared to our prior guidance, which assumed a decline in the range of 62%-68% year over year. Note that our total net revenue ranges assumes sales of Advanced Wound Care products in the range of $151 million-$171 million, sales of our Surgical & Sports Medicine products in the range of $26 million-$27 million, and grant income of $1.9 million.

With respect to our profitability expectations, our updated guidance continues to assume improving quarterly adjusted EBITDA performance on a sequential basis, which is expected to result in more than a 60% reduction in adjusted EBITDA loss in the second half of 2026 as compared to the first half of 2026 at the low end of the range, and more than 80% reduction in adjusted EBITDA loss in the second half of 2026 as compared to the first half of 2026, including the expectation of positive adjusted EBITDA generation in the fourth quarter. Note that we have materially reduced our expense profile this year.

Cost savings related to our March 2026 and June 2026 restructurings and incremental cost reduction activities in the second half of 2026 are expected to result in a total reduction in operating expense of approximately $45 million, of which approximately $32 million is related to restructuring. With that, I'll turn the call back over to Gary for closing remarks.

Gary Gillheeney Sr.: Thanks, Dave. The market disruption has reshaped the skin substitute category, and while we support many of the revisions to reimbursement, the uncertainty around comments on discarded product has created real confusion for our customers, particularly around Apligraf. During the past year, we've been engaging constructively with federal policymakers on the distinct value of living cell-based biologic therapies, including why discarded product rules should reflect how these products are manufactured and administered. While that work continues, we're encouraged by the progress as customers increasingly are returning to products proven to deliver positive outcomes for patients. Biologic therapies made from biologic sources, and as a living cell-based biologic, Apligraf is supplied as a single fixed-size unit with a limited shelf life.

For more than 25 years, the science behind our technologies have been clear. Our biologic PMA products, Apligraf, Dermagraft, and TransCyte, have been rigorously studied and FDA approved based on clinical data. We believe our biologic PMAs and clinical evidence that underpin them will be the cornerstone of the market going forward. Organogenesis introduced living cell technology with Apligraf, and today we are building on that foundation to define a sustainable future for Advanced Wound Care. We are emerging from this reset as a biologic company supported by multiple regenerative technology platforms. Amnuvx, now under BLA review, would, if approved, add to our arsenal of biologic therapies that harness the body's natural healing mechanisms.

Going forward, we will continue to leverage our advanced science and unmatched breadth of clinical data as part of our vision to be a force for meaningful change and set a higher expectation in healing and recovery. With that, I'll turn the call over to the operator to open the call up for questions. Thank you.

Operator: Thank you, sir. If you'd like to ask a question, please signal by pressing star 11 on your telephone keypad. If you're using a speakerphone, please make sure your mute function is turned off to allow your signal to reach our equipment. Please stand by for our first question. Our first question comes from the line of Ryan Zimmerman of BTIG. Your line is now open.

Ryan Zimmerman: Good afternoon, Gary and Dave. Can you hear me okay?

Dave Francisco: We can, Ryan.

Ryan Zimmerman: All right, great. A lot of things are up in the air in this market. It's been, I think, more challenging for everyone than anticipated. What is your current thinking, Gary, around how the recovery curve takes shape? What I'm trying to understand is just as we've cycled through this, it's taken longer than I think everyone's anticipated. Do you have a sense for when you think you kind of come out the other side of this dynamic? Given we saw the PFS rates, we saw the OPPS last night, not a whole lot changed from what was proposed. It seems like Medicare is sticking with what they're intended from the proposal.

Gary Gillheeney Sr.: For us, we think we certainly are coming up on the other side. The market has clearly bottomed out. We're seeing an improvement in overall market expansion. We've seen it from Q1-Q2. Q3 data is still not available yet, but based on our market share gains and our growth, our expectation is the market is expanding again. As the market absorbs all of the changes that are going on, Ryan, there's still a lot of inventory in the market. We estimate almost 20% of the sale of skin substitutes in Q3 are from companies who are no longer in the space, that have actually

Ryan Zimmerman: Right

Gary Gillheeney Sr.: just dumped a lot of inventory. As that process is through, which we think it will in the next quarter or two, as confusion, particularly around our products and the utilization of Apligraf, is getting clearer, we're starting to see a path forward. I think we've certainly hit the bottom, and we're coming up on the other side. It's just a matter of who's left in the market and how customers respond to who's left in the market. We think the focus on efficacy and evidence is really important. There's audits going on still out there, and the ones that win are the ones that have evidence, RCTs in those audits.

It's moving back to evidence, which is what we've always wanted it to be.

Ryan Zimmerman: Right. Just to be clear, Gary, if there's a price versus volume dynamic that's occurring here where there is lower price for these products, but the volumes are starting to pick up, that began in Q1. Arguably, by the end of the fourth quarter, we should be through that kind of dynamic?

Gary Gillheeney Sr.: I would think by the end of the year, certainly through Q1, we're going to understand and start to see a lot more clarity, because price can only go so far. I think the volume and price will settle out at least by Q1, and we'll get a better sense of how the market's really moving and what the potential of the market is.

Ryan Zimmerman: Okay. Dave, for you made a comment. You guys have done a lot of cost cutting through this year to manage through things. I'm just wondering if you could spend a minute on kind of the adjusted EBITDA comments in fourth quarter being positive, given the guidance. Maybe help us kind of bridge from the revenue composition to the positive adjusted EBITDA, because given what we saw this quarter, it does require some tighter expense control again in fourth quarter.

Dave Francisco: Yeah. So, you're right, Ryan. We have done quite a bit. As we mentioned, we've done two RIFs, and then as you kind of look at the differential between the operating expenses between the second quarter and the third, we're down about $10 million on an adjusted basis. So, from our standpoint, that's, call it $40 million annualized, and then there was almost $8.5 million of incremental savings on headcount that was in COGS. So, that's where we came up with the Some of these are project deferrals and things of that nature, so that's where we're at about $45 million on an annualized basis. So, we have made a lot of progress there.

I think when you look at the differential between the potential for break-even position that we've got in the fourth quarter, it's really at the high end of the range. So, we've continued to see progress in a reduction in adjusted EBITDA. Some of that was revenue, some of it was cost cuts, but down, call it $12 million-$13 million each quarter improvement. So, again, if we're on the low end, it's still negative, but on the higher end, if we hit those numbers, then we expect to be net positive.

Ryan Zimmerman: Okay. Understood. Well, I will leave it there and hop back in queue, guys. Thank you.

Gary Gillheeney Sr.: Thanks, Ryan.

Dave Francisco: Thanks, Ryan.

Operator: One moment for our next question. Our next question comes from the line of Ravi Misra of Truist Securities. Your line is now open.

Ravi Misra: Hi. Thanks for taking the question. I appreciate the time. Just one, I guess, on the market size. I wonder if it's a little bit of a last man standing type of environment here, and it looks like, at least the sequential commentary that you've made, just curious if you're willing to, based on that and the competitors exiting the space, are you looking to call a bottom here, or is there visibility in sight on the other end yet in terms of where this market is shaping out. It was a miss on the top line, at least versus consensus, but it was better, right, than we had expected, I think, versus the prior quarters.

Just help me understand, what's the trajectory, I guess, of any recovery that may or may not be emerging, if you could give detail on that. Thanks. Sorry for the convoluted question.

Gary Gillheeney Sr.: Sure. Obviously, I don't think anyone can predict with great accuracy this market, but I think what we've seen, the change between Q1 and Q2 as it relates to market expansion, the market coming back, we're seeing something similar in Q3, though again, the data isn't there. It's not complete yet. So, we clearly have seen the bottom. Without question, we've seen the bottom. I think the challenge is there is a lot of low-cost inventory that's going to flush through that's impacting the market. When that goes through the system, which we believe it'll be gone by the end of the year, we think that the trajectory forward is going to be strong.

We think it'll be double digit from a market expansion perspective, and we think there'll be four or five major competitors in the space with quality products. We think if the LCDs are put back in place, which we think that there's a strong possibility that could happen, that would also redefine the market probably to those same four or five competitors with solid products and solid evidence. Then I think the market will steadily grow because the wounds aren't going away. The fact that a lot of patients are not being treated, things are a lot worse in those hospitals right now, and they need to be treated. So they will get treated.

It's just a matter of over time, clinicians getting comfortable enough to step back in with skin substitutes.

Ravi Misra: Thanks. On the PDUFA commentary, I'm sorry if you discussed this already, we've been jumping through calls. With the pushout now on the date and the expense management that you were talking about with Ryan just now, how do we think about the incremental costs, I guess, around that delay, and how should that be built into your model in the sense of, is the identification of the remediation efforts going to take a year, two years? Any framework around timing or expenses you could put around that would be great.

Gary Gillheeney Sr.: Sure. Based on our current estimate, we expect the remediation to be done by September 30th, 2027. So that's our expected timeframe right now. We believe the incremental cost, or I should say the total cost for the remediation is about $8 million, which is about $4 million of incremental cost. The other $4 million are kind of pulled forward, things that we were going to do anyway to enhance the facility and improve margins. The FDA wants us to put them in place now, which is fine. So it's an $8 million total spend, a $4 million pull forward. Dave?

Dave Francisco: That's right. With about 25% of that done in 2026, the remainder in 2027 through, as Gary said, the third quarter.

Operator: Okay. I am showing no further questions remaining at this time. That does conclude our conference for today. Thank you for your participation.

Gary Gillheeney Sr.: Thank you.

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