Organogenesis Holdings Inc.

Welcome, ladies and gentlemen, to the first 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 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 poor-looking statements that are based on current expectations of management and involve inherent risks and uncertainties that could cause actual results that differ materially from those indicated. including the risks and uncertainties described in this 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 poor-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 poor-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 these 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. Goheny Sr. Organogenesis Holdings President, Chief Executive Officer, and Chair of the Board. Please go ahead, sir.

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. They 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. That revenue declined 58% year over year, driven by a 63% decline in sales of our advanced wound care products. Sales of our surgical and sports medicine products were flat year over year. And as expected, the withdrawal of the LCD coverage policies for skin substitutes announced on December 24th And comments regarding discarded product on December 30th 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 four months of 2026 as a result of CMS's commentary on December 30th. As discussed on our fourth quarter call, we believe the comments on December 30th 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 size 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's December 30th 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 comments on December 30th will be less of a headwind as we progress through 2026. We continue to believe CMS's 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 in clinically validated skin substitute products, particularly PMA products like . While we will continue to engage with CMS on this issue, our level of uncertainty as to the timing of the 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 expectations 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 nine 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 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 Renew program. On April 28th, 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 non-surgical biologic option designed to address pain and improve functionality, particularly for patients with severe disease who lack an approved non-surgical option. We initiated a rolling VLA submission in December of 2025 with non-clinical 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 penetrations 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 6th, we announced the completion of a randomized controlled trial evaluating the safety and efficacy of PurePly AM plus standard of care versus standard of care alone in the management of non-healing diabetic foot ulcers. This was a prospective multi-center 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 the p-value of less than 0.0477. This strong performance is an important study which underscores the clinical efficacy of PureApply AM and the management of non-healing DFUs. These wounds pose a significant burden to patients and are extremely costly to our healthcare system. We believe publication of these impactful results will strongly support PureApply AM's inclusion in future coverage policies, underscoring its critical role in the wound healing algorithm. Further demonstrating the clinical effectiveness of our Purify 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 in 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 of 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.

Thanks, Gary. I'll begin with a review of our first quarter financial results. unless otherwise specified or growth rates referenced during my prepared remarks or 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 and 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 growth. 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 6.4% 6 million write-downs of certain non-recurring 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 non-cash amortization and certain non-recurring costs in both periods, Our non-GAAP property 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 dividends and the non-cash appreciation 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 with 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 non-recurring inventory write-down adjustments for excess and obsolete inventory. We've included a detailed reconciliation of GAAP and non-GAAP adjusted loss in our first 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 31st, 2025. We believe we are well capitalized with our cash on hand and other components of working capital, availability under a well-developed 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 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 is soon to decline in the range of 25% to 38% year-over-year. Note the change in our total revenue expectations is a result of our biased assumptions regarding sales of our advancing repair 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 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've 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.

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 VLA submission, and generated strong clinical evidence supporting PureFly AM, further validating our long-term strategy. We expect the operating environment will remain difficult through the first nine months of 2026 with sequential revenue improvement of 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.

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 while we compile the Q&A roster. Our first question comes from Ryan Zimmerman with BTIG. Please go ahead.

Hi, Gary, Dave. This is Izzy on for Ryan. Thank you for taking the questions. 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?

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 two 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 preauthorization is required. There was also an issue with a large MAC that was struggling to process claims the entire first quarter. In fact, we've 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 three-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 30th, 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 Applegraph brand, are down about 22%. You know, we're definitely seeing some share gain from our perspective, but the just contraction in the market, the issues around wastage, and the technology challenges, you know, with the Mac and Wiser are things that we didn't see, you know, when we had our call in February. Dave, anything to add?

No, no, that's absolutely right.

I appreciate that. Thank you. And, I mean... 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?

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, Applegraph, or to come out with an indication for use. There's been no instructions or clarity on exactly what their wastage policy is. 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 Applegraph appropriately for patients that need it.

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 that the 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? Thanks for taking the questions.

Yeah, 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 two things. One is, you know, the customer confusion should abate as we move through the year. And then in addition to that, you know, 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.

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