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DATE

Thursday, May 7, 2026 at 5 p.m. ET

CALL PARTICIPANTS

  • Chief Executive Officer — Gary S. Gillheeney
  • Chief Financial Officer — David Francisco

TAKEAWAYS

  • Net Product Revenue -- $36.3 million, a 58% decline, attributed mainly to advanced wound care headwinds and reimbursement policy disruption.
  • Advanced Wound Care Revenue -- $29.5 million, a 63% decrease, linked to coverage changes and market confusion following CMS commentary.
  • Surgical & Sports Medicine Revenue -- $6.8 million, stable year over year, showing resilience relative to other business lines.
  • Gross Profit -- $10.5 million, or 29% of net product revenue, down from 73%, reflecting substantial margin decline.
  • Inventory Write-Downs -- $4.3 million, related to facility closure ($1 million) and regulatory changes ($3.3 million).
  • Non-GAAP Gross Profit -- $14.8 million, or 41% of net product revenue, after adjusting for inventory write-downs.
  • Operating Expenses -- $106.1 million, down $7.3 million (6%) versus last year, driven by reduced SG&A and one-off items despite higher R&D spend.
  • Operating Loss -- $68.9 million GAAP, an increase of $42.1 million, with a non-GAAP operating loss of $56 million, up $36.7 million.
  • GAAP Net Loss -- $53.2 million, widening by $34.3 million from prior year; net loss to common shareholders was $56.2 million including preferred stock impacts.
  • Adjusted Net Loss -- $43.7 million, up from $13.4 million; adjusted EBITDA loss was $48.2 million, up from $12.5 million.
  • Cash & Liquidity -- $92.1 million in cash and no outstanding debt; access to a $75 million revolving facility underscores balance sheet flexibility.
  • 2026 Revenue Guidance -- Updated to $270 million-$310 million, a projected 45%-52% decrease, versus previous expectation of a 25%-38% decline.
  • 2026 Cost Reduction Initiatives -- Restructuring completed in March resulted in 88 headcount reductions and closure of the St. Petersburg facility, yielding expected annualized cost savings of $14 million.
  • Clinical Milestone -- BLA submission for ReNu to the FDA finalized April 28; management described this as a "significant milestone" for the knee osteoarthritis program.
  • PuraPly AM Clinical Evidence -- "Statistically significant wound closure at 12 weeks" in non-healing diabetic foot ulcer trial, supporting reimbursement and publication strategies.
  • 2026 Profitability Outlook -- Positive adjusted EBITDA targeted for the second half, with cost controls expected to reduce operating expenses (excluding COGS) by 25% for the year and more than 30% in the year's second half.

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RISKS

  • CEO Gillheeney stated, "these market headwinds have not abated. Rather, in some cases, it has resulted in clinicians moving away from skin substitutes entirely," highlighting persistent negative revenue impact and potential for ongoing market contraction.
  • CFO Francisco noted, "Our 2026 total revenue guidance now reflects the expectation that we see more measured improvement in clinician confusion and the overall operating environment as we move through the year," indicating uncertainty and a slower recovery.
  • Management reported operating loss and adjusted EBITDA loss both widened substantially due to ongoing disruption, pressure on margins, and inventory write-downs.
  • CEO Gillheeney said, "our level of uncertainty as to the timing of a resolution has unfortunately increased since the fourth quarter earnings call in February," showing increased risk regarding policy clarification by CMS.

SUMMARY

Organogenesis Holdings (ORGO 6.13%) attributed its 58% net revenue decline primarily to significant operating headwinds resulting from CMS reimbursement policy changes and market confusion regarding skin substitute wastage, which disproportionately affected advanced wound care sales. Management explicitly cited ongoing industry-wide clinician confusion and the lack of timely CMS clarification as key obstacles to near-term revenue and profitability improvement. Restructuring actions, including a workforce reduction and facility closure, were executed to offset demand contraction and are projected to save $14 million annually. The company reported progress on strategic initiatives, including completion of the BLA submission for ReNu and release of favorable PuraPly AM clinical trial data, potentially strengthening its product and reimbursement position long term. 2026 guidance now assumes a deeper full-year revenue contraction in the 45%-52% range, with management projecting sequential improvement and a return to positive adjusted EBITDA in the second half as cost management measures take effect.

  • Trial evidence for PuraPly AM demonstrated statistically significant benefit, potentially bolstering future reimbursement policies and market positioning not factored elsewhere.
  • Cash position, access to a $75 million revolving credit facility, and no debt were emphasized as supporting operational flexibility despite projected revenue headwinds.
  • Leadership characterized the impact from CMS policy interpretations as "transient" but confirmed risk of longer duration, exacerbating coverage and utilization uncertainty throughout most of 2026.
  • Comments in the Q&A specified technology and processing delays with MACs and WISeR further compounded Q1 disruptions, requiring customers to resubmit unprocessed claims for January and February.

INDUSTRY GLOSSARY

  • CMS: Centers for Medicare & Medicaid Services, the federal agency overseeing healthcare reimbursement policy directly impacting payor coverage for wound care and skin substitute products.
  • LCD: Local Coverage Determination, a regional reimbursement policy impacting what products and procedures are covered under Medicare within specific jurisdictions.
  • MAC: Medicare Administrative Contractor, an organization processing Medicare claims and implementing LCDs across assigned territories.
  • BLA: Biologics License Application, an FDA submission seeking regulatory approval to market a new biologic product.
  • PMA: Premarket Approval, the FDA's most stringent regulatory pathway for high-risk medical devices and some biologics.
  • WISeR: Reference to an administrative reimbursement system implicated in Q1 claims processing delays; not industry-standard nomenclature but cited as a factor in claim disruption.
  • DFU: Diabetic Foot Ulcer, a chronic wound complication in diabetic patients representing a core clinical application for company products.

Full Conference Call Transcript

Gary Gillheeney: Thank you, operator, and welcome, everyone, to Organogenesis Holdings First Quarter 2026 Earnings Conference Call. I'm joined on the call today by Dave Francisco, our Chief Financial Officer. Let me start with a brief agenda of what we'll cover during our prepared remarks. I'll begin with an overview of our first quarter revenue results and provide an update on key developments in recent months. Dave will then provide you with an in-depth review of our first 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.

Then I will provide you with some closing comments before we open the call up for questions. Beginning with a review of our revenue results for Q1, our revenue results reflect the significant challenges in the operating environment outlined on our fourth quarter call in February. Net revenue declined 58% year-over-year, driven by a 63% decline in sales of our Advanced Wound Care products. Sales of our Surgical & Sports Medicine products were flat year-over-year. And as expected, the withdrawal of the LCD coverage policies for skin substitutes announced on December 24 and comments regarding discarded products on December 30, resulted in clinicians' confusion and material disruption in the market during the first quarter.

Our team performed well during this period of unprecedented disruption in the skin substitute market. As a leader in the industry, we expect to gain share in this new environment as we leverage the largest, most comprehensive portfolio across multiple FDA classifications. Despite the significant decline in our product revenue in the first quarter, we believe we enhanced our market share position as our unit volume outperformed the declines that have been reported across the industry. This is encouraging in isolation, but it's even more impressive when viewed in light of the significant impact on utilization of our PMA-approved product over the first 4 months of 2026 as a result of CMS' commentary on December 30.

As discussed on our fourth quarter call, we believe the comments on December 30 regarding product wastage were intended to proactively address activity from certain competitors in the market that were attempting to exploit the new payment policies by focusing on larger sized skin substitute products, specifically amniotic products. The initial market response to these comments was significant clinician confusion and uncertainty. Unfortunately, these market headwinds have not abated. Rather, in some cases, it has resulted in clinicians moving away from skin substitutes entirely. While CMS' December 30 commentary represents what we believe to be a material but transient impact on 2026 revenue trends, the harm to patients is both more severe and enduring.

The impact on utilization of our clinically superior PMA-approved skin substitutes doesn't just delay healing, it exposes our most vulnerable patients to preventable complications, infections, amputations and potentially fatal outcomes. This market disruption requires urgent correction. We believe the significant clinician confusion impacting utilization of our PMA-approved products as a result of the agency's comment on December 30 will be less of a headwind as we progress through 2026. We continue to believe CMS' efforts to overhaul coverage and payment for our market represents meaningful steps towards reform. We believe that CMS should clarify the comments on discarded products to stem the unintended impact on patient access to clinically validated skin substitute products, particularly PMA products like Apligraf.

While we will continue to engage with CMS on this issue, our level of uncertainty as to the timing of a resolution has unfortunately increased since the fourth quarter earnings call in February. Accordingly, we have updated our expectations for total revenue in 2026 in this afternoon's press release. Our 2026 total revenue guidance now reflects the expectation that we see more measured improvement in clinician confusion and the overall operating environment as we move through the year. While we continue to expect improvement in our revenue results on a sequential basis over the balance of the year, our overall revenue outlook reflects a more measured recovery this year.

The prolonged recovery is now expected to impact our financial results over the first 9 months of 2026 with a return to more normalized profitability now expected in the fourth quarter. Given the impact on our revenue expectations as a result of the prolonged recovery, we completed a restructuring in March. The restructuring included a workforce reduction of 88 employees and the closing of operations in our St. Petersburg, Florida facility and is expected to result in cost reductions of approximately $14 million on an annualized basis. While our 2026 is off to a difficult start, I want to make it clear that I am very optimistic about our future.

We continue to expect to drive significant market share gains in the second half of 2026, and we remain confident in the long-term opportunity for Organogenesis. Our overall position is very strong, and it is from this strong position that we are making capital investments that will support our company's future growth and continued leadership. Before I turn the call over to David, I wanted to provide updates on some key regulatory and clinical developments in recent months, beginning with an update of our ReNu program. On April 28, we announced the completion of our BLA submission to the FDA.

This represents a significant milestone in our effort to bring a new regenerative therapy intended to treat a large and growing unmet need in symptomatic knee osteoarthritis, a serious condition affecting more than 30 million Americans. We believe ReNu has the potential to meaningfully change the treatment paradigm by offering a nonsurgical biologic option designed to address pain and improve functionality, particularly for patients with severe disease who lack an approved nonsurgical option. We initiated a rolling BLA submission in December of 2025 with nonclinical modules and have now completed the application with the submission of the clinical and chemistry manufacturing and control modules.

We are confident in the progress of our regulatory engagement, and we look forward to continuing our productive discussions with the FDA during the review process. We believe gathering robust and comprehensive clinical and real-world evidence is an essential component of developing a competitive product portfolio and driving further penetration in the markets where we compete. Science and evidence have always been core to our foundation. And as coverage policies evolve, evidence will be the currency of credibility, and we intend to remain a leader in these markets.

On April 6, we announced the completion of a randomized controlled trial evaluating the safety and efficacy of PuraPly AM plus standard of care versus standard of care alone in the management of non-healing diabetic foot ulcers. This was a prospective multicenter randomized controlled trial of 170 patients. The trial achieved its primary endpoint, demonstrating statistically significant wound closure at 12 weeks compared to standard of care alone with a p-value of less than 0.0477. This strong performance is an important study, which underscores the clinical efficacy of PuraPly AM in the management of non-healing DFUs. These wounds pose a significant burden to patients and are extremely costly to our health care system.

We believe publication of these impactful results will strongly support PuraPly AM's inclusion in future coverage policies, underscoring its critical role in the wound healing algorithm. Further demonstrating the clinical effectiveness of our PuraPly antimicrobial technology and advancing ReNu represents further validation of our long-term strategy to invest in expanding the body of clinical evidence supporting our technology and developing regenerative medicine solutions that address significant unmet medical needs as we expand our mission to include transformative new markets for Organogenesis.

With more than 40 years in regenerative medicine and a diverse evidence-based portfolio of 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 highly innovative, highly efficacious products that deliver on our mission of advancing healing and recovery beyond our customers' expectations. With that, let me turn the call over to David.

David Francisco: Thanks, Gary. I'll begin with a review of our first quarter financial results. Unless otherwise specified, all growth rates referenced during my prepared remarks are on a year-over-year basis. Net product revenue for the first quarter was $36.3 million, down 58% year-over-year. As Gary mentioned, these results came in below the expectations we provided on our Q4 call, which called for total revenue decline of approximately 50% year-over-year. Our Advanced Wound Care net product revenue for the first quarter was $29.5 million, down 63%. Net product revenue from Surgical & Sports Medicine products for the first quarter was $6.8 million, flat year-over-year.

Our total revenue results for the first quarter include $1 million of income related to the grant issued from the Rhode Island Life Sciences Hub, offsetting the employee-related costs in our Smithfield facility. This compares to no impact in the prior year period. Gross profit for the first quarter was $10.5 million or 29% of net product revenue compared to 73% last year. First quarter cost of goods included $4.3 million of inventory write-down adjustments for excess and obsolete inventory resulting from a facility closure and LTD regulatory changes of $1 million and $3.3 million, respectively. Excluding inventory write-down adjustments, non-GAAP gross profit was $14.8 million or 41% of net product revenue.

Operating expenses for the first quarter were $106.1 million compared to $113.4 million last year, a decrease of $7.3 million or 6%. Excluding cost of goods sold of $25.8 million for the first quarter and $23.7 million last year, our non-GAAP operating expenses were $80.3 million compared to $89.7 million last year, a decrease of $9.4 million or 10%. The year-over-year change in operating expenses, excluding cost of goods sold was driven by a $7.3 million or 10% decrease in SG&A expenses and a $6.6 million write-down of certain nonrecurring expenses, which impacted the first quarter of 2025, offset partially by a $4.5 million or 42% increase in research and development expenses.

Operating loss for the first quarter was $68.9 million compared to an operating loss of $26.7 million last year, an increase of $42.1 million. Excluding noncash amortization and certain nonrecurring costs in both periods, our non-GAAP operating loss was $56 million compared to $19.3 million last year, an increase of $36.7 million year-over-year. GAAP net loss for the first quarter was $53.2 million compared to a net loss of $18.8 million last year, an increase in net loss of $34.3 million. Net loss to common stockholders for the first quarter was $56.2 million compared to a net loss of $21.6 million last year.

Net loss to common stockholders includes the impact of the cumulative dividend and the noncash accretion to redemption value of our convertible preferred stock. Adjusted net loss for the first quarter was $43.7 million compared to $13.4 million last year. Adjusted net loss excludes after-tax impacts of intangible amortization, write-down of assets held for sale, employee severance and benefits as well as other exit costs associated with the company's restructuring activities and nonrecurring inventory write-down adjustments for excess and obsolete inventory. We've included a detailed reconciliation of GAAP to non-GAAP adjusted loss in our press release this afternoon. Adjusted EBITDA loss for the first quarter was $48.2 million compared to adjusted EBITDA loss of $12.5 million last year.

Turning to the balance sheet. As of March 31, 2026, the company had $92.1 million in cash, cash equivalents and restricted cash and no outstanding debt obligations compared to $94.3 million in cash, cash equivalents and restricted cash and no outstanding debt obligations as of December 31, 2025. We believe we are well capitalized with our cash on hand and other components of working capital, availability under our revolving facility of up to $75 million and net cash flows from product sales. Turning to our 2026 outlook, which we updated this afternoon's press release.

As Gary outlined earlier, our 2026 total revenue guidance now reflects the expectation that we see a more measured improvement in clinician confusion and overall operating environment as we move through the year. As a result, we now expect total revenue -- net revenue for the full year 2026 of $270 million to $310 million, representing a decline in the range of 45% to 52% year-over-year and compared to our prior guidance range, which assumed a decline in the range of 25% to 38% year-over-year. Note the change in our total revenue expectations is a result of revised assumptions regarding sales of our advanced wound care products.

Our updated total revenue guidance continues to reflect the expectations we see sequential improvement in our revenue trends in the second quarter, however, at a more measured rate versus what our prior guidance assumed, resulting in first half revenue decline in the range of approximately 52% to 49% year-over-year. We continue to expect strong sequential revenue growth in both the third and fourth quarters of 2026. However, the low end of our guidance range now assumes a more prolonged recovery in market-related headwinds, resulting in a second half revenue decline similar to the first half of 2026.

With respect to our profitability expectations, our updated guidance continues to assume improved quarterly adjusted EBITDA performance on a sequential basis and positive adjusted EBITDA generation in the second half of 2026. Given the lower revenue expectations for 2026 and the related impact on gross profit, we have adjusted our assumptions for operating expenses, excluding cost of goods sold to reduce the impact on our profitability and cash flow this year. Specifically, we now expect to reduce our operating expenses, excluding cost of goods sold, approximately 25% year-over-year in 2026, including more than 30% year-over-year in the second half of 2026.

Note these updated assumptions are inclusive of estimated cost savings in the third and fourth quarters related to our recently announced restructuring of approximately $7 million. With that, I'll turn the call back over to Gary for closing remarks.

Gary Gillheeney: Thanks, Dave. In closing, the first quarter was a challenging start to the year as expected. I want to thank our team for their performance and resilience during a period of unprecedented market disruption. But despite the headwinds, we believe we've enhanced our market share position, met a significant milestone by completing our renewed BLA submission and generated strong clinical evidence supporting PuraPly AM, further validating our long-term strategy. We expect the operating environment will remain difficult through the first 9 months of 2026 with sequential revenue improvement over the balance of the year and a return to more normalized profitability in the fourth quarter.

We remain confident in our position as a leader in regenerative medicine with a diverse and evidence-based portfolio and more than 40 years of innovation in service of our mission to advance healing and recovery for the patients who depend on us most. With that, I'll turn the call over to the operator to open the call up for questions.

Operator: [Operator Instructions] Our first question comes from Ryan Zimmerman with BTIG.

Iseult McMahon: This is Iseult on for Ryan. I was hoping to start with spending some time on the first quarter performance. Could you unpack a little bit what you guys saw throughout the quarter and particularly what changed between the fourth quarter call in February and today in terms of volumes? I mean what was better or worse than expected?

Gary Gillheeney: Sure. I'll start. Well, we've certainly seen a lot of disruption as we expected you normally would see with a change in reimbursement. But the level of complexity of that change was more than we've seen in the past. So you had 2 sites of care with complete changes in the reimbursement model in addition to changing the actual reimbursement for each product. We also had the issue in the first quarter around WISeR. So WISeR really did have an impact in the first quarter. We didn't expect some of the challenges that they've had technology-wise in the states in which pre-authorization is required.

There was also an issue with a large MAC that was struggling to process claims the entire first quarter. In fact, we just recently started to process claims for March. And unfortunately, customers have to rebuild for claims in January and February. So all of that disruption on top of what you normally see when there's a reimbursement change. So we've typically guided to a 3-month impact of a reimbursement change. But with the additional complexity that we're seeing now and the issue of wastage, which came out in December 30, has created enormous confusion in the market, which is why this prolonged delay in market recovery. So what we've seen is a contraction of the market by about 63%.

That's an enormous contraction in the market. We're certainly down less than that. We believe we've taken share. In fact, our core brands, excluding our Apligraf brand are down about 22%. So we're definitely seeing some share gain from our perspective, but just contraction in the market, the issues around wastage and the technology challenges with the MAC and WISeR are things that we didn't see when we had our call in February. Dave, anything to add?

David Francisco: No, no, that's absolutely right. Let them all.

Iseult McMahon: I appreciate that. And what, if anything -- or do you have any line of sight as to when we might get an update from CMS clarifying some of their comments around these wastage policies?

Gary Gillheeney: We don't have any direct clarity on when they would do that. We're still engaged with them. Our objective is to either get them to exempt PMAs because of all of the confusion around the handling and the billing and usage of a biologic like our product Apligraf or to come out with an indication for use. There's been no instructions or clarity on exactly what their wastage policy is. So we don't have clarity on when they will change or when they'll bring clarity, but we're certainly bringing clarity to our customers, and we're seeing more and more comfort in utilizing the product Apligraf appropriately for patients that need it.

Iseult McMahon: Got it. And then last one for me, kind of dovetails into guidance for the year. I was just curious what gives you confidence in that back half recovery? I understand this updated range accounts for more moderation through the remainder of the year. But have you seen anything through April and May that gives you more confidence?

David Francisco: Yes. We did see improvement month-over-month in the first quarter, and that's continued into April. So that's one part of it. And what we've always expected here, as Gary mentioned, we're going to continue to gain share. But there's 2 things. One is the customer confusion should abate as we move through the year. And then in addition to that, we think the competition dynamics will be quite a bit different at that point as well. So that's how we've built up our forecast with sequential growth quarter-over-quarter as we move through the year.

Operator: We are currently showing no remaining questions in the queue at this time. This does conclude our conference for today. Thank you for your participation.