ORGO

Image source: The Motley Fool. Thursday, Aug. 6, 2026 at 5:00 p.m. ET Organogenesis Holdings President, Chief Executive Officer, and Chair of the Board - Gary S. Gillheeney, Sr. Chief Financial Officer - David Francisco Operator: Welcome, ladies and gentlemen, to the second quarter 2026 earnings conference call for Organogenesis Holdings Inc. [Operator Instructions] 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 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. Gillheeney, Sr., Organogenesis Holdings President, Chief Executive Officer, and Chair of the Board. Please go ahead, sir. Gary Gillheeney: Thank you, operator, and welcome everyone to Organogenesis Holdings' Second Quarter 2026 Earnings Conference Call. I'm joined on the call today by David 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 a brief review of our results and key developments in the second quarter and in recent months. Dave will then provide you with an in-depth review of our second 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 some closing comments before we open the call for your questions. Let me begin with a review of our results and key developments in Q2. Our revenue results reflect the significant contraction and slow pace of recovery in the skin substitute market as a result of the actions and comments from CMS in late December of 2025. Total revenue declined 58% year-over-year in the second quarter, driven primarily by a 61% decline in sales of our Advanced Wound Care products. We were pleased to see measured improvement in our business trends in the second quarter. On balance, we were encouraged to see the operating environment improve from what we experienced during the first quarter. Net product revenue increased 18% quarter-over-quarter in Q2, driven primarily by a 23% sequential increase in sales of our Advanced Wound Care products. As a leader in the industry, we leveraged our most comprehensive portfolio across multiple FDA classifications, including the only biologic PMA-approved product, Apligraf, to enhance our market share position with a 30% increase in wound care unit volume on a quarter-over-quarter basis, outperforming the declines that have been reported across the board in the industry. That said, revenue results for Q2 were below the expectations we outlined in our first quarter call. We attribute the majority of this performance to a slower pace of recovery from the significant contraction in the skin substitute market as a result of the sweeping changes from CMS to reform coverage and payment. The prolonged recovery has also prompted us to make important strategic decisions that are intended not only to reduce our cost structure, but also better position Organogenesis for success going forward. While operating and financial results in 2026 have been significantly impacted by the contraction in the skin substitute market this year, I want to make it clear that I remain very optimistic about our future. CMS' efforts to overhaul coverage and payment for the skin substitute market have addressed the waste, fraud and abuse from bad actors exploiting the system. With the proposed hospital Outpatient Prospective Payment System and the physician fee schedule announced last month, we believe CMS is now seeking to promote stabilization in the market. They've held payment rates steady. They've reinforced the differentiation of PMA products and the importance of clinical data in determining coverage. And we applaud these actions and look forward to expanding access to patients who need these products. 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 on 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 been and always will be the core of our foundation. As coverage policies evolve, evidence will be the currency of credibility, and we intend to remain in the lead. Importantly, we continue to advance our strategic initiative to expand the company's mission into entirely new markets with the ReNu program. Recently, the FDA formally accepted Amnuvx as the proprietary trade name for the biologic product previously known as ReNu. And if approved, Amnuvx will establish a new market category for a biologic product representing a transformational opportunity for Organogenesis in the more than 30 million Americans living with symptomatic knee osteoarthritis. Let me share a few updates on our progress in each of these important strategic initiatives in recent months. The compelling clinical results from our RCT evaluating the safety and efficacy of PuraPly AM in the management of non-healing diabetic foot ulcers, or DFUs, was submitted for publication. The results of this 170-patient study showed statistically significant DFU wound closure at 12 weeks. We believe publication 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. The RCT is complemented by an additional exciting publication in the Journal of Wound Care showing reduced rates of non-traumatic lower leg amputation among Medicare beneficiaries with DFU treated with PuraPly AM versus standard of care. The use of PuraPly AM in nearly 11,000 patients was associated with a statistically significant 20% lower overall amputation rate and an even lower 40% rate for amputations above or at the level of the knee. These new studies build on a significant body of evidence of clinical benefit of PuraPly AM, adding to the previous 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 determinations. On July 27, we announced peer-reviewed results published in the Journal of Wound Care demonstrating Affinity's benefit in the most challenging and complex venous leg ulcers, or VLU. The data showed statistically significant improvements in wound closure at 12 and 16 weeks for Affinity plus standard of care across both wound duration groups studied, offering compelling new evidence in one of the hardest to treat populations in chronic wound care. These results reinforce Affinity's benefit in the hard-to-heal wounds, the population that drives the greatest clinical burden and cost in VLU treatment. As those costs continue to rise, particularly within Medicare, this is a meaningful step forward for patients, clinicians and payers. Complementing our existing diabetic foot ulcer data, these results add to a growing body of RCT and real-world evidence that strengthens the case for expanded coverage across two of the most common costly wound types. With respect to our recent progress in our Amnuvx program, on July 6, we announced that the FDA accepted our biologic license application for Amnuvx and has set a PDUFA target action date of April 24, 2027. We believe this highly differentiated regenerative therapy has the potential to meaningfully change the treatment paradigm by offering a nonsurgical biologic option designed to address pain and improve function, particularly in patients with severe disease who lack approved nonsurgical options, and we look forward to continued engagement with the FDA as they complete their review. Before turning the call over to Dave, I want to comment on our updated outlook and important strategic decisions we've made subsequent to quarter end. We have updated our expectations for total revenue in 2026 in this afternoon's press release. While we continue to expect improvement in our revenue results on a sequential basis in the third and fourth quarters, our 2026 revenue guidance now reflects the expectation that we see a more measured pace of recovery as compared to what was contemplated in our prior expectation for total revenue in 2026. Given the impact of a prolonged recovery on our revenue expectations, we completed a restructuring in June. The restructuring included a workforce reduction of 138 employees and is expected to result in cost reductions of approximately $18 million on an annualized basis. This is our second restructuring announced in 2026, which together are expected to reduce annual operating expenses by more than $32 million on an annual basis. Importantly, the benefits of these activities are not limited to expense reductions. Rather, we believe our commercial team is now positioned to maximize the opportunity ahead as the skin substitute market expands from the recalibration over the first half of 2026. With that, let me turn the call over to Dave. David Francisco: Thanks, Gary. I'll begin with a review of our second quarter financial results. Unless otherwise specified, all growth rates referenced in my prepared remarks are for the 3-month period ending June 30, 2026, and are on a year-over-year basis. Net product revenue was $42.8 million, down 58% year-over-year. Our advanced Wound Care net product revenue was $36.1 million, down 61%. Net product revenue from Surgical & Sports Medicine products was $6.7 million, down 18% year-over-year. Our total revenue results included $1 million of income related to the grant issued by the Rhode Island Life Sciences Hub, offsetting our employee-related costs in our Smithfield facility. This compares to $0.2 million in the prior year period. Our second quarter results reflect notable improvement in growth trends on a sequential basis. Specifically, our total revenue increased 18% quarter-over-quarter, driven by a 23% increase in sales of Advanced Wound Care products. Gross profit was $19.1 million, or 45% of net product revenue, compared to 73% last year. Cost of goods included $1.8 million of restructuring-related charges. Excluding these adjustments, non-GAAP gross profit was $20.9 million or 49% of net product revenue. Operating expenses were $94.7 million compared to $113.6 million last year, a decrease of $18.8 million or 17%. Excluding cost of goods sold of $23.7 million for the second quarter and $27.6 million last year, our non-GAAP operating expenses were $63 million compared to $83.4 million last year, a decrease of $20.4 million, or 25%. The year-over-year change in operating expenses excluding cost of goods sold was driven by a $19.8 million or 27% decrease in SG&A expenses, offset partially by a $7.9 million or 76% increase in research and development expenses. Note, the second quarter R&D expenses included $5.6 million of non-recurring termination costs associated with various R&D programs and vendors. Operating expenses excluding cost of goods sold declined $9.3 million or 12% on a sequential basis, driven primarily by the company's March 2026 restructuring. By way of reminder, the March 2026 restructuring is expected to reduce our operating expenses by approximately $13.4 million on an annualized basis. Operating loss was $51 million compared to an operating loss of $12.6 million last year, an increase of $38.4 million. Excluding non-cash amortization and certain non-recurring costs in both periods, our non-GAAP operating loss was $41.1 million compared to $10 million last year, an increase of $31.1 million year-over-year. GAAP net loss was $96.3 million compared to a net loss of $9.4 million last year. Note, GAAP net loss in the period includes approximately $30 million of noncash tax expense related to the recording of full valuation allowance on the company's deferred tax assets. Net loss to common stockholders was $99.3 million compared to a net loss of $12.2 million last year. Net loss to common stockholders includes the impact of the cumulative dividend and the noncash accretion to redemption value on our convertible preferred stock. Adjusted net loss was $89 million compared to $7.5 million last year. We've included a detailed reconciliation of GAAP to non-GAAP adjusted loss in our press release this afternoon. Adjusted EBITDA loss is $34.4 million compared to adjusted EBITDA loss of $3.6 million last year. Turning to the balance sheet, as of June 30, 2026, the company had $46.8 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 expect that our cash on hand and other components of working capital as of June 30, 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. Today, the company entered into an ATM agreement with BTIG and Citizens JMP Securities, pursuant to which the company may offer to sell shares of its common stock, having an aggregate offering price of up to $75 million from time to time through sales agents. Sales under the ATM agreement, if any, will be made pursuant to the company's effective shelf registration statement on Form S-3 and related prospectus supplement. The company intends to use these net proceeds from any sales under the ATM agreement for working capital, general corporate purposes, research and development activities and other strategic initiatives. Turning to our 2026 outlook, which we've updated in this afternoon's press release. As Gary outlined earlier, our 2026 total revenue guidance now reflects the softer-than-expected results in the second quarter and the expectation that we see a more measured recovery in the overall operating environment as we move into the second half of the year. As a result, we now expect total net revenue for the full year of 2026 of $179 million to $215 million, representing a decline in the range of 62% to 68% year-over-year and compared to our prior guidance range, which assumed a decline in the range of 45% to 52% year-over-year. Note our total revenue range assumes sales of Advanced Wound Care products in the range of $151 million to $183 million, sales of our Surgical & Sports Medicine products in the range of $26 million to $30 million and grant income of $1.9 million. Our updated total revenue guidance continues to reflect the expectation that we see sequential improvement in our revenue trends in the third and fourth quarters, however, at a more measured rate versus what our prior guidance has assumed, resulting in a second half revenue decline in the range of approximately 64% to 74% year-over-year. 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 nearly 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 90% 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. 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 32% year-over-year in 2026, including more than 40% 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 March 2026 and June 2026 restructurings of approximately $7 million and $9 million, respectively. With that, I'll turn the call back over to Gary for closing remarks. Gary Gillheeney: Thanks, Dave. 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. The competitive landscape has changed dramatically in just a few months since CMS announced sweeping changes to coverage and 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. Organogenesis is doubling down on wound care. We are leaders because our business is built on efficacy and outcomes, and that is driving our expanding share as the market resets. Customer trust matters now in this new market more than ever before, and simply put, we believe we have the best evidence-based skin substitute products in wound care, bar none. We expect to enhance our leadership position by leveraging our portfolio to provide integrated healing solutions that substantially improve outcomes while lowering the overall cost of care. With that, I'll turn the call over to the operator for questions. Operator: [Operator Instructions] Our first question comes from Ryan Zimmerman from U.S. Bancorp. Iseult McMahon: Gary and Dave, this is Izzy on for Ryan. I just want to start to get kind of your higher-level thoughts on the broader market dynamics and what is going to give you confidence that Medicare is working to stabilize the market beyond just what we've seen in the OPPS proposal. Gary Gillheeney: So this is Gary, Izzy. So what we're seeing is month over month, we're seeing continued growth in the space. We're seeing more clinicians getting more comfortable with the current coverage and payment structure that's in place now. We still have a ways to go. And CMS reinstated the $127.14 reimbursement rate. I think they did that with the intention of stabilizing the market and bringing consistency to the market. They also continue to identify the tiers where they recognize PMA products and 510(k) products and the 361. So maintaining that tier structure is also bringing stability and signaling evidence is still an important function here and will carry weight going forward. So we think the stability, recognizing PMA products and we're starting to see more clinicians starting to use at least our product as we continue to take a fairly significant share in both the first and second quarters. Iseult McMahon: That's helpful. And as we start to think about the back half of the year, I was hoping you could speak a little bit more about the pacing that's baked into guidance for third quarter and fourth quarter? David Francisco: Yes, sure. This is Dave. Yes, so, as Gary mentioned, we were pleased with the strong sequential growth that we saw between Q1 and Q2. Obviously, as we talked about up fairly significantly in Advanced Wound Care units, up 30%. So that's coming off the Q1 trough. So our expectation is that the movement from here would be continued share gains, but more modest and obviously the growth on a sequential basis would be much more modest than what we'd anticipate or what we experienced in the first to the second quarter. So we see some modest growth into the third quarter with a little bit more strength in the fourth. Iseult McMahon: Helpful. And if I could just squeak one more in. Could you speak to what products are actually being paid for versus what might be held up in the market, whether it's synthetics, amniotics, anything you can provide there? Gary Gillheeney: We don't really see any particular product being held up. The concern is postapplication upon audit, would there be a potential clawback on those products? And what we're seeing in the market is products without RCTs are at significant risk. Sometimes -- many times, they're considered investigational. So clinicians are getting very concerned about products without RCTs. There's a flight to quality, which is why we're seeing the 30% growth that we're seeing in the market share gains because our products have significant evidence. So we think it's more postapplication that clinicians are concerned about the clawbacks and the potential paybacks for products that just don't have evidence in the space. Operator: [Operator Instructions] Our next question comes from Ravi Misra from Truist. Ravi Misra: So just want to kind of return to the guidance and the outlook that you provided on the call. Can you help us understand kind of what gives you comfort to get -- what are the kind of the puts and takes that get us to the low end or the high end of the guide? And then how should we think about that given your commentary just now on surging concerns, the 30% kind of sequential volume growth, how should we think of that on a 3Q versus 4Q basis and then returning maybe back to market in '27? Or is that kind of an elongated thing as well? Gary Gillheeney: Well, I'll start. I think as you look at our low guidance, as Dave indicated, what we've guided to, it's not what we've seen. Our second quarter growth has been fairly significant at 30%, but what we're guiding to is lower growth and lower share gains on the conservative side. So we're kind of guiding to where we are, but slightly less than the experience -- the growth experience we had in Q2. That's why we have more confidence in the low end of the range. Now the high end of the range, and I'll let Dave jump in, is basically reflecting the growth that we are seeing right now in our business with some small, what I call, market expansion at the end of the third quarter and fourth quarter. So we're guiding to less than the growth that we're seeing right now on the low end, and on the high end, we're guiding to exactly what we're growing at right now with the small market expansion. So that's kind of the range. Dave, you can jump in. David Francisco: No, absolutely. And just, Ravi, it's a little bit more biased towards Q4 than it is Q3 just because of the evolution of the business in the market. Ravi Misra: Great. And then maybe a follow-up. Just on Dermagraft, I saw in your Q that you're kind of shelving that for now. Can we talk about the opportunity there that you're maybe stepping away from or the thinking around when that does come back to market and the rationale for why? Gary Gillheeney: Well, it was slowing down the manufacturing build-out of Dermagraft to preserve cash. So Dermagraft is still a product that we expect to launch. We didn't have significant revenue built in '27 in our thinking or '28, but it will delay it probably a year of its intended launch which was somewhere in the middle of '27. So probably launch in the middle of '28, but it's a focus on preserving cash and going slower with that build-out. We think that's prudent right now. Operator: Please stand by. Do we have another question from Ravi? Ravi Misra: No, well, if there's time, yes, I guess I'll ask one more. Amnuvx, just help us think about maybe how you see this slotting into the competitive landscape if and when approved. Gary Gillheeney: Sure. So Amnuvx, if approved, will be the first biologic in this space. So we think it will have a unique place in this space. We don't see anything else coming to market before Amnuvx. So that's a very positive place to be. Obviously, the clinical data is strong, the safety data, the safety profile of the product is extremely strong. So there's a lot of strong tailwinds driving this product. We expect with the PDUFA date of April 2027, if approved, we would launch the product with a temporary code until we get a permanent code, which we would expect at the end of '27, the beginning of 2028, and we would expect the product to have a fairly significant ramp as we ramp our infrastructure. So the product is unique. There is no other biologic in this space, and we're pretty excited about it. Operator: I'm showing no further questions at this time. That does conclude our conference call for today. Thank you for your participation. Before you buy stock in Organogenesis, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and Organogenesis wasn’t one of them. The 10 stocks that made the cut could produce monster returns in the coming years. Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you’d have $400,209!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you’d have $1,375,393!* Now, it’s worth noting Stock Advisor’s total average return is 964% — a market-crushing outperformance compared to 215% for the S&P 500. Don't miss the latest top 10 list, available with Stock Advisor, and join an investing community built by individual investors for individual investors. See the 10 stocks » *Stock Advisor returns as of August 13, 2026. This article is a transcript of this conference call produced for The Motley Fool. While we strive for our Foolish Best, there may be errors, omissions, or inaccuracies in this transcript. As with all our articles, The Motley Fool does not assume any responsibility for your use of this content, and we strongly encourage you to do your own research, including listening to the call yourself and reading the company's SEC filings. Please see our Terms and Conditions for additional details, including our Obligatory Capitalized Disclaimers of Liability. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. Organogenesis (ORGO) Q2 2026 Earnings Call Transcript was originally published by The Motley Fool

Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Management attributes the 58% year-over-year revenue decline to a significant contraction in the skin substitute market following CMS regulatory actions in late 2025. The company achieved a 30% sequential increase in wound care unit volume, which management views as a flight to quality by clinicians toward proven PMA-approved products like Apligraf. Strategic restructuring, including two workforce reductions in 2026, aims to lower the cost structure by $32 million annually to align with a more measured market recovery. Management believes CMS's proposed payment systems signal a move toward market stabilization by reinforcing the importance of clinical data and maintaining tiered payment structures. The company is doubling down on its wound care leadership by prioritizing clinical evidence as the primary 'currency of credibility' for future coverage determinations. Operational focus has shifted toward preserving cash, leading to the decision to delay the Dermagraft manufacturing build-out and subsequent launch until mid-2028. Updated 2026 guidance assumes a more measured recovery pace than previously anticipated, with total revenue now expected between $179 million and $215 million. Management expects sequential improvement in the second half of 2026, targeting positive adjusted EBITDA generation by the fourth quarter. The Amnuvx program (formerly ReNu) represents a transformational opportunity for symptomatic knee osteoarthritis, with a PDUFA target action date set for April 24, 2027. Guidance for the remainder of the year is biased toward fourth-quarter strength as the market recalibrates and clinicians gain comfort with new payment structures. The company intends to leverage its ATM agreement for up to $75 million to fund working capital, R&D, and other strategic initiatives as needed. A second restructuring in June 2026 resulted in a workforce reduction of 138 employees and is expected to yield $18 million in annualized savings. Q2 results included a $30 million non-cash tax expense related to a full valuation allowance on deferred tax assets. R&D expenses for the quarter included $5.6 million in non-recurring termination costs associated with various programs and vendors. Management identified potential 'clawbacks' and audits as a significant risk for clinicians using products that lack robust randomized controlled trials (RCTs). One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. Management noted that CMS's reinstatement of specific reimbursement rates and maintenance of product tiers (PMA vs. 510(k)) are key signals of market stabilization. Clinicians are reportedly becoming more comfortable with the current coverage structure, though a full recovery remains ongoing. The low end of the guidance range assumes growth slightly below the 30% sequential volume increase seen in Q2, while the high end assumes current growth rates plus modest market expansion. Revenue growth is expected to be more modest in Q3 with increased strength in Q4. The company is slowing the manufacturing build-out to preserve cash, pushing the expected launch from mid-2027 to mid-2028. Management stated this delay is a prudent measure given the current revenue environment and does not impact long-term expectations for the product. If approved, Amnuvx would be the first biologic in its category, addressing a population of 30 million Americans with severe disease. The company plans to launch with a temporary code in 2027, transitioning to a permanent code and significant infrastructure ramp by early 2028.

Interested in Organogenesis? Here are five stocks we like better. Second-quarter revenue fell 58% year over year to $42.8 million, driven by a 61% decline in Advanced Wound Care sales amid ongoing CMS coverage and payment changes. The company reported a $96.3 million GAAP net loss, including approximately $30 million in non-cash tax expense. Despite the sharp annual decline, net product revenue increased 18% sequentially and Advanced Wound Care sales rose 23%, with wound-care volume up 30% from the first quarter. Management cited market-share gains, a CMS-driven “flight to quality” and supporting clinical evidence for products including PuraPly AM and Affinity. Organogenesis cut its 2026 revenue outlook to $179 million-$215 million and expects improvement to be weighted toward the fourth quarter, when it targets positive adjusted EBITDA. The company expects restructuring actions to reduce annual operating expenses by more than $32 million, but cash declined to $46.8 million and it authorized a potential $75 million at-the-market stock offering. Organogenesis (NASDAQ:ORGO) reported a sharp year-over-year decline in second-quarter revenue as the skin substitute market continued to adjust to coverage and payment changes from the Centers for Medicare & Medicaid Services, while management pointed to sequential improvement in product sales and market share gains. President, Chief Executive Officer and Chair Gary S. Gillheeney Sr. said total revenue declined 58% from the prior-year period, primarily reflecting a 61% decline in Advanced Wound Care sales. He attributed the results to a significant contraction and slower-than-anticipated recovery in the skin substitute market following CMS actions and comments in late December 2025. → Meta’s Earnings Drop Shows Wall Street Wants More Than Ad Growth Still, the company said net product revenue rose 18% sequentially in the second quarter, driven by a 23% increase in Advanced Wound Care product sales. Gillheeney said Organogenesis’ wound care unit volume increased 30% from the first quarter, which he said outperformed reported industry declines. Chief Financial Officer Dave Francisco said net product revenue was $42.8 million in the second quarter, down 58% year over year. Advanced Wound Care revenue totaled $36.1 million, down 61%, while Surgical & Sports Medicine revenue was $6.7 million, down 18%. → 4 Oil and Gas ETF Plays as Prices Stay Sky-High Total revenue also included $1 million of income related to a grant from the Rhode Island Life Sciences Hub, which offset employee-related costs at the company’s Smithfield facility. That compared with $0.2 million in grant income in the prior-year period. Gross profit was $19.1 million, or 45% of net product revenue, compared with 73% a year earlier. Cost of goods sold included $1.8 million in restructuring-related charges. Excluding those charges, non-GAAP gross profit was $20.9 million, or 49% of net product revenue, Francisco said. → Ulta's Growth Is Real, But So Are the Risks Operating expenses fell 17% to $94.7 million. Excluding cost of goods sold, non-GAAP operating expenses declined 25% to $63 million, as a $19.8 million reduction in selling, general and administrative expenses was partially offset by a $7.9 million increase in research and development expenses. R&D expense included $5.6 million of non-recurring termination costs associated with R&D programs and vendors. The company reported an operating loss of $51 million, compared with an operating loss of $12.6 million in the prior-year quarter. Its GAAP net loss was $96.3 million, versus a $9.4 million loss a year earlier. Francisco said the quarterly net loss included about $30 million in non-cash tax expense from recording a full valuation allowance on deferred tax assets. Adjusted EBITDA loss was $34.4 million, compared with an adjusted EBITDA loss of $3.6 million in the prior-year period. Gillheeney said CMS efforts to revise coverage and payment practices have addressed waste, fraud and abuse by certain market participants. He said the agency’s proposed hospital outpatient prospective payment system and physician fee schedule, announced in July, appeared intended to promote market stabilization by holding payment rates steady and reinforcing differentiation for premarket approval, or PMA, products and products supported by clinical data. During the question-and-answer session, Gillheeney said CMS reinstated a reimbursement rate of $127.14 and maintained product tiers recognizing PMA products, 510(k) products and Section 361 products. He said clinicians have become more comfortable with the current payment and coverage framework but remain concerned about potential post-application audits and clawbacks. He said products without randomized controlled trials, or RCTs, face greater risk of being considered investigational, contributing to what he described as a “flight to quality.” Organogenesis highlighted recently submitted and published clinical evidence for its wound care portfolio. The company said results from a 170-patient RCT of PuraPly AM in non-healing diabetic foot ulcers showed statistically significant wound closure at 12 weeks and were submitted for publication. It also cited a Journal of Wound Care publication involving nearly 11,000 Medicare beneficiaries with diabetic foot ulcers. The study associated PuraPly AM treatment with a 20% lower overall non-traumatic lower-leg amputation rate compared with standard of care, along with a 40% lower rate for amputations above or at the knee level. Separately, the company said peer-reviewed results published July 27 in the Journal of Wound Care showed statistically significant improvements in wound closure at 12 and 16 weeks for Affinity plus standard of care in complex venous leg ulcers. Organogenesis completed a June restructuring that reduced its workforce by 138 employees and is expected to generate approximately $18 million in annualized cost reductions. Together with a restructuring announced in March, the actions are expected to reduce annual operating expenses by more than $32 million, management said. Francisco said the company had $46.8 million in cash equivalents and restricted cash as of June 30, down from $94.3 million at the end of 2025. The company had no outstanding debt obligations at either date. Management expects available cash, working capital components and net cash flow from product sales to fund operating expenses and capital expenditures for at least the next 12 months. The company also entered into an at-the-market equity offering agreement with BTIG and Citizens JMP Securities, allowing it to sell up to $75 million of common stock from time to time. Organogenesis said any proceeds would be used for working capital, general corporate purposes, research and development, and other strategic initiatives. For 2026, Organogenesis lowered its revenue outlook to a range of $179 million to $215 million, representing a year-over-year decline of 62% to 68%. Its prior outlook contemplated a decline of 45% to 52%. Advanced Wound Care revenue is projected at $151 million to $183 million. Surgical & Sports Medicine revenue is projected at $26 million to $30 million. Grant income is expected to total $1.9 million. The company expects sequential revenue improvement in the third and fourth quarters, though at a more measured pace than previously anticipated. Francisco said the outlook is weighted more toward the fourth quarter and assumes positive adjusted EBITDA in that period. The company expects to reduce operating expenses excluding cost of goods sold by approximately 32% for the full year, including more than 40% in the second half. Organogenesis said the FDA accepted its biologics license application for Amnuvx, previously known as ReNu, and established an April 24, 2027, PDUFA target action date. Gillheeney said that, if approved, Amnuvx would be the first biologic in its treatment area for symptomatic knee osteoarthritis and could be launched using a temporary code before a permanent code is expected around late 2027 or early 2028. The company is also slowing the manufacturing build-out for Dermagraft to preserve cash. Gillheeney said the expected launch timing has shifted from the middle of 2027 to approximately the middle of 2028, adding that the company had not assumed significant Dermagraft revenue in its 2027 or 2028 planning. Organogenesis Inc operates as a regenerative medicine company focused on the development, manufacturing and commercialization of therapeutic solutions for wound care, surgical repair and sports medicine. The company's product portfolio addresses a range of acute and chronic tissue repair needs, leveraging bioengineered skin substitutes, human placental-derived products and other allografts designed to promote healing and reduce scarring. Organogenesis markets its therapies to hospitals, outpatient clinics, wound care centers and other healthcare providers. Key offerings include Apligraf, a living skin substitute for treatment of diabetic foot ulcers and venous leg ulcers; Dermagraft, a cryopreserved human fibroblast-derived dermal substitute; Grafix, a placental membrane allograft for complex and chronic wounds; and TheraSkin, a cryopreserved human skin allograft used in surgical and reconstructive procedures. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "Organogenesis Q2 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for August 2026.

CANTON, Mass., Aug. 06, 2026 (GLOBE NEWSWIRE) -- Organogenesis Holdings Inc. (Nasdaq: ORGO), a leading regenerative medicine and tissue innovations company focused on empowering healing through the development, manufacture, and sale of product solutions for the Advanced Wound Care and Surgical & Sports Medicine markets, today reported financial results for the second quarter ended June 30, 2026. Second Quarter 2026 Financial Results Summary: Net revenue of $42.8 million for the second quarter of 2026, a decrease of $58.0 million compared to net revenue of $100.8 million for the second quarter of 2025. Net revenue for the second quarter of 2026 consists of: Net loss of $96.3 million for the second quarter of 2026, compared to a net loss of $9.4 million for the second quarter of 2025, an increase in net loss of $86.9 million. Adjusted net loss of $89.0 million for the second quarter of 2026, compared to an adjusted net loss of $7.5 million for the second quarter of 2025, an increase in adjusted net loss of $81.5 million. Adjusted EBITDA loss of $34.4 million for the second quarter of 2026, compared to Adjusted EBITDA loss of $3.6 million for the second quarter of 2025, an increase in EBITDA loss of $30.7 million. "We are encouraged by signs of measured improvement in business trends in the second quarter, though the pace of recovery from the significant market contraction is slower than we expected," said Gary S. Gillheeney, Sr., President, Chief Executive Officer and Chair of the Board for Organogenesis. "Our business is built on efficacy and outcomes, and that is driving our expanding share as the market resets and customers turn to solutions they can trust. We remain convinced that we occupy the strongest long-term position and will remain the leader with the best evidence-based regenerative medicine products, while advancing the ReNu program to unlock new markets for the company." Second Quarter 2026 Financial Results: Net product revenue for the second quarter of 2026 was $42.8 million, compared to $100.8 million for the second quarter of 2025, a decrease of $58.0 million, or 58%. The decrease in net product revenue was driven by a decrease of $56.6 million, or 61%, in net product revenue for Advanced Wound Care products. Gross profit for the second quarter of 2026 was $19.1 million, or 45% of net product revenue, compared to $73.1 million, or 73% of net product revenue for the second quarter of 2025, a decrease of $54.0 million, or 74%. Operating expenses for the second quarter of 2026 were $94.7 million compared to $113.6 million for the second quarter of 2025, a decrease of $18.8 million, or 17%. Cost of goods sold was $23.7 million for the second quarter of 2026, compared to $27.6 million for the second quarter of 2025, a decrease of $4.0 million, or 14%.   Selling, general and administrative expenses were $54.0 million for the second quarter of 2026, compared to $73.8 million for the second quarter of 2025, a decrease of $19.8 million, or 27%. R&D expense was $18.3 million for the second quarter of 2026, compared to $10.4 million for the second quarter of 2025, an increase of $7.9 million, or 76%. Operating loss for the second quarter of 2026 was $51.0 million, compared to an operating loss of $12.6 million for the second quarter of 2025, an increase in operating loss of $38.4 million. Total other income, net, for the second quarter of 2026 was $0.1 million, compared to $0.7 million for the second quarter of 2025, a decrease of $0.6 million. Net loss for the second quarter of 2026 was $96.3 million, or $(0.77) per share, compared to net loss of $9.4 million, or $(0.10) per share, for the second quarter of 2025, an increase in net loss of $86.9 million, or $(0.67) per share. Adjusted net loss was $89.0 million for the second quarter of 2026, compared to adjusted net loss of $7.5 million for the second quarter of 2025, an increase in adjusted net loss of $81.5 million. Adjusted EBITDA loss was $34.4 million for the second quarter of 2026, compared to Adjusted EBITDA loss of $3.6 million for the second quarter of 2025, an increase in adjusted EBITDA loss of $30.7 million. Non-GAAP operating loss was $41.1 million for the second quarter of 2026, compared to non-GAAP operating loss of $10.0 million for the second quarter of 2025, an increase in non-GAAP operating loss of $31.1 million. Six Months ended June 30,2026 Financial Results: Net product revenue for the six months ended June 30, 2026 was $79.1 million, compared to $187.5 million for the six months ended June 30, 2025, a decrease of $108.4 million, or 58%. The decrease in net product revenue was driven by a decrease of $107.0 million, or 62%, in net product revenue for Advanced Wound Care products. Gross profit for the six months ended June 30, 2026 was $29.6 million, or 37% of net product revenue, compared to $136.1 million, or 73% of net product revenue for the six months ended June 30, 2025, a decrease of $106.5 million, or 78%. Operating expenses for the six months ended June 30, 2026 were $200.9 million compared to $227.0 million for the six months ended June 30, 2025, a decrease of $26.2 million, or 12%. Cost of goods sold was $49.4 million for the six months ended June 30, 2026, compared to $51.4 million for the six months ended June 30, 2025, a decrease of $1.9 million, or 4%.   Selling, general and administrative expenses were $119.2 million for the six months ended June 30, 2026, compared to $146.3 million for the six months ended June 30, 2025, a decrease of $27.2 million, or 19%. R&D expense was $33.5 million for the six months ended June 30, 2026, compared to $21.0 million for the six months ended June 30, 2025, an increase of $12.4 million, or 59%. Operating loss for the six months ended June 30, 2026 was $119.9 million, compared to an operating loss of $39.3 million for the six months ended June 30, 2025, an increase in operating loss of $80.6 million. Total other income, net, for the six months ended June 30, 2026 was $0.5 million, compared to $1.7 million for the six months ended June 30, 2025, a decrease of $1.2 million. Net loss for the six months ended June 30,2026 was $149.4 million, or $(1.21) per share, compared to net loss of $28.2 million, or $(0.27) per share, for the six months ended June 30, 2025, an increase in net loss of $121.2 million, or $(0.94) per share. Adjusted net loss was $132.8 million for the six months ended June 30, 2026, compared to adjusted net loss of $20.9 million for the six months ended June 30, 2025, an increase in adjusted net loss of $111.8 million. Adjusted EBITDA loss was $82.5 million for the six months ended June 30, 2026, compared to Adjusted EBITDA loss of $16.2 million for the six months ended June 30, 2025, an increase in adjusted EBITDA loss of $66.4 million. Non-GAAP operating loss was $97.1 million for the six months ended June 30, 2026, compared to non-GAAP operating loss of $29.3 million for the six months ended June 30, 2025, an increase in non-GAAP operating loss of $67.7 million. As of June 30, 2026, the Company had $46.8 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.Fiscal Year 2026 Outlook: For the year ending December 31, 2026, the Company now expects: Total net revenue between $179.0 million and $215.0 million, representing a decline in the range of 62% to 68%, as compared to total net revenue of $564.2 million for the year ended December 31, 2025. Second Quarter Earnings Conference Call: Management will host a conference call at 5:00 p.m. Eastern Time on August 6th to discuss the results of the quarter, and to provide a corporate update with a question and answer session. Those who would like to participate may access the live webcast here, or access the teleconference here. The live webcast can also be accessed via the company’s website at investors.organogenesis.com. The webcast will be archived on the company website for approximately one year. Non-GAAP Financial Measures Our management uses financial measures that are not in accordance with generally accepted accounting principles in the United States, or GAAP, in addition to financial measures in accordance with GAAP to evaluate our operating results. These non-GAAP financial measures should be considered supplemental to, and not a substitute for, our reported financial results prepared in accordance with GAAP. Our management uses Adjusted EBITDA, adjusted net income (loss) and non-GAAP operating income (loss) to evaluate our operating performance and trends and make planning decisions. Our management believes Adjusted EBITDA, adjusted net income (loss) and non-GAAP operating income (loss) help identify underlying trends in our business that could otherwise be masked by the effect of the items that we exclude. Accordingly, we believe that Adjusted EBITDA, adjusted net income (loss) and non-GAAP operating income (loss) provide useful information to investors and others in understanding and evaluating our operating results, enhancing the overall understanding of our past performance and prospects, and allowing for greater transparency with respect to key financial metrics used by our management in its financial and operational decision-making. Adjusted EBITDA Adjusted EBITDA consists of GAAP net loss excluding: (i) interest (income) expense, net, (ii) income tax (benefit), (iii) depreciation and amortization, (iv) amortization of intangible assets, (v) stock-based compensation expense, and (vi) additional infrequently occurring adjustments described in more detail below. The following table presents a reconciliation of GAAP net loss to non-GAAP EBITDA and non-GAAP Adjusted EBITDA, for the periods presented: Adjusted Net Loss Adjusted net loss is defined as GAAP net loss plus (i) amortization of intangible assets and (ii) additional infrequently occurring adjustments described in more detail below, less the estimated tax on these adjustments. The following table presents a reconciliation of GAAP net loss to non-GAAP adjusted net loss, for the periods presented: Non-GAAP Operating Loss Non-GAAP operating loss is defined as GAAP loss from operations plus (i) amortization of intangible assets and (ii) additional infrequently occurring adjustments described in more detail below. The following table presents a reconciliation of GAAP net loss from operations to non-GAAP operating loss, for the periods presented: Forward-Looking Statements This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements relate to expectations or forecasts of future events. Forward-looking statements may be identified by the use of words such as “forecast,” “intend,” “seek,” “target,” “anticipate,” “believe,” “expect,” “estimate,” “plan,” “outlook,” and “project” and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. Such forward-looking statements include statements relating to the Company’s expected revenue, competitive positioning and long-term opportunities. Forward-looking statements with respect to the operations of the Company, strategies, prospects, and other aspects of the business of the Company are based on current expectations that are subject to known and unknown risks and uncertainties, which could cause actual results or outcomes to differ materially from expectations expressed or implied by such forward-looking statements. These factors include, but are not limited to: (1) the impact of any changes to the coverage and reimbursement levels for the Company’s products, particularly in light of CMS’ updated 2026 Medicare reimbursement and coverage changes; (2) the Company faces significant and continuing competition, which could adversely affect its business, results of operations and financial condition; (3) rapid technological change could cause the Company’s products to become obsolete and if the Company does not enhance its product offerings through its research and development efforts, it may be unable to effectively compete; (4) to be commercially successful, the Company must convince physicians that its products are safe and effective alternatives to existing treatments and that its products should be used in their procedures; (5) the Company’s ability to raise funds to expand its business; (6) the Company has incurred losses in the prior periods and may incur losses in the future; (7) changes in applicable laws or regulations; (8) the possibility that the Company may be adversely affected by other economic, business, and/or competitive factors; (9) the Company’s ability to maintain production or obtain supply of its products in sufficient quantities to meet demand; (10) the Company’s ability to build out its Smithfield, Rhode Island facility on time and on budget; (11) whether the Company is able to obtain regulatory approval for and successfully commercialize ReNu; and (12) other risks and uncertainties described in the Company’s filings with the Securities and Exchange Commission, including Item 1A (Risk Factors) of the Company’s Form 10-K for the year ended December 31, 2025 and its subsequently filed periodic 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. About Organogenesis Holdings Inc. Organogenesis Holdings Inc. is a leading regenerative medicine and tissue innovations company focused on empowering healing through the development, manufacture, and sale of solutions for the Advanced Wound Care and Surgical & Sports Medicine markets. Organogenesis offers a comprehensive portfolio of innovative regenerative products to address patient needs across the continuum of care. For more information, visit www.organogenesis.com. CONTACT: Investor Inquiries: ICR Healthcare Mike Piccinino, CFA [email protected] Press and Media Inquiries: Organogenesis [email protected]

CANTON, Mass., July 27, 2026 (GLOBE NEWSWIRE) -- Organogenesis Holdings Inc. (Nasdaq: ORGO), a leading regenerative medicine company focused on product solutions for the Advanced Wound Care and Surgical and Sports Medicine markets, today announced published results from a prospective, multicenter, randomized controlled trial (RCT) evaluating Affinity plus standard of care (SoC) compared to SoC alone in the management of complex venous leg ulcers (VLUs). The results were published in the Journal of Wound Care demonstrating statistically significant improvements in wound closure at weeks 12 and 16 for the Affinity + SoC group across two wound duration strata studied, providing compelling new peer-reviewed evidence for one of the most difficult-to-treat wound populations in chronic wound care. “These clinically meaningful results demonstrate the value of Affinity as a protective barrier in challenging VLUs,” said Patrick Bilbo, Chief Operating Officer of Organogenesis. “Paired with our DFU data, this strengthens the case that Affinity delivers meaningful outcomes for the patients who need it most.” The 206-patient trial, which randomized 1:1 to Affinity + SoC or SoC alone, followed patients for 24 weeks after a four-week run-in period. Across both baseline wound duration (BWD) strata, which included wounds present for more than 6 months and wounds present for more than 24 months, the Affinity + SoC group achieved significantly higher rates of wound closure than SoC alone at weeks 12 and 16 (p<0.05). This trial builds on the growing body of evidence for Affinity, now spanning RCTs and real-world data, across multiple chronic wound indications. These findings reinforce the benefit of Affinity in the hardest-to-heal wounds, the population that drives the greatest clinical burden and cost in VLU treatment. As VLU costs continue to grow, particularly within the Medicare population, these results present a meaningful step forward for patients, clinicians, and payers. This VLU data set complements existing Affinity evidence in diabetic foot ulcers (DFUs), reinforcing the clinical and economic rationale for expanded coverage across two of the most prevalent and costly chronic wound types. About Affinity Affinity is the only hypothermically stored human placental allograft composed of fresh, unaltered amniotic membrane that retains its native extracellular matrix scaffold and living cells for use as a protective barrier. Never dehydrated or frozen, Affinity is minimally manipulated, aseptically processed, and uniquely preserved in a fresh state. Affinity is intended for use as a protective barrier in the management of acute and chronic wounds. About Organogenesis Holdings Inc. Organogenesis Holdings Inc. is a leading regenerative medicine company focused on the development, manufacture, and commercialization of solutions for the Advanced Wound Care and Surgical and Sports Medicine markets. Organogenesis offers a comprehensive portfolio of innovative regenerative products to address patient needs across the continuum of care. For more information, visit www.organogenesis.com. Forward-Looking Statements This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements relate to expectations or forecasts of future events. Forward-looking statements may be identified by the use of words such as “forecast,” “intend,” “seek,” “target,” “anticipate,” “believe,” “expect,” “estimate,” “plan,” “outlook,” and “project” and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. Such forward-looking statements include statements relating to the expected benefits to patients from using Affinity and to the Company from the sale of Affinity. Forward-looking statements are subject to known and unknown risks and uncertainties, which could cause actual results or outcomes to differ materially from expectations expressed or implied by such forward-looking statements. These factors include, but are not limited to: (1) the impact of any changes to the coverage and reimbursement levels for Affinity and the Company’s other products, particularly in light of CMS’ updated 2026 Medicare reimbursement and coverage changes; (2) the Company faces significant and continuing competition, which could adversely affect its business, results of operations and financial condition; (3) rapid technological change could cause the Company’s products to become obsolete and if the Company does not enhance its product offerings through its research and development efforts, it may be unable to effectively compete; (4) to be commercially successful, the Company must convince physicians that its products are safe and effective alternatives to existing treatments and that its products should be used in their procedures; (5) the Company’s ability to raise funds to expand its business; (6) the Company has incurred losses in the prior periods and may incur losses in the future; (7) changes in applicable laws or regulations; (8) the possibility that the Company may be adversely affected by other economic, business, and/or competitive factors; (9) the Company’s ability to maintain production or obtain supply of its products in sufficient quantities to meet demand; (10) the Company’s ability to build out its Smithfield, Rhode Island facility on time and on budget; and (11) other risks and uncertainties described in the Company’s filings with the Securities and Exchange Commission, including Item 1A (Risk Factors) of the Company’s Form 10-K for the year ended December 31, 2025 and its subsequently filed periodic 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. CONTACT: Contacts Investor Inquiries: ICR Healthcare Mike Piccinino, CFA [email protected] Press and Media Inquiries: Cheston Turbyfill [email protected]

Image source: The Motley Fool. Thursday, May 7, 2026 at 5 p.m. ET Chief Executive Officer — Gary S. Gillheeney Chief Financial Officer — David Francisco 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. Before you buy stock in Organogenesis, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and Organogenesis wasn’t one of them. The 10 stocks that made the cut could produce monster returns in the coming years. Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you’d have $475,926!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you’d have $1,296,608!* Now, it’s worth noting Stock Advisor’s total average return is 981% — a market-crushing outperformance compared to 205% for the S&P 500. Don't miss the latest top 10 list, available with Stock Advisor, and join an investing community built by individual investors for individual investors. See the 10 stocks » *Stock Advisor returns as of May 8, 2026. This article is a transcript of this conference call produced for The Motley Fool. While we strive for our Foolish Best, there may be errors, omissions, or inaccuracies in this transcript. As with all our articles, The Motley Fool does not assume any responsibility for your use of this content, and we strongly encourage you to do your own research, including listening to the call yourself and reading the company's SEC filings. Please see our Terms and Conditions for additional details, including our Obligatory Capitalized Disclaimers of Liability. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. Organogenesis (ORGO) Q1 2026 Earnings Transcript was originally published by The Motley Fool

CANTON, Mass., May 07, 2026 (GLOBE NEWSWIRE) -- Organogenesis Holdings Inc. (Nasdaq: ORGO), a leading regenerative medicine and tissue innovations company focused on empowering healing through the development, manufacture, and sale of product solutions for the Advanced Wound Care and Surgical & Sports Medicine markets, today reported financial results for the first quarter ended March 31, 2026. First Quarter 2026 Financial Results Summary: Net revenue of $36.3 million for the first quarter of 2026, a decrease of $50.4 million compared to net revenue of $86.7 million for the first quarter of 2025. Net revenue for the first quarter of 2026 consists of: Net revenue from Advanced Wound Care products of $29.5 million, a decrease of 63% from the first quarter of 2025. Net revenue from Surgical & Sports Medicine products of $6.8 million, consistent with the first quarter of 2025. Net loss of $53.2 million for the first quarter of 2026, compared to a net loss of $18.8 million for the first quarter of 2025, an increase in net loss of $34.3 million. Adjusted net loss of $43.7 million for the first quarter of 2026, compared to an adjusted net loss of $13.4 million for the first quarter of 2025, an increase in adjusted net loss of $30.3 million. Adjusted EBITDA loss of $48.2 million for the first quarter of 2026, compared to Adjusted EBITDA loss of $12.5 million for the first quarter of 2025, an increase in EBITDA loss of $35.6 million. “The first quarter presented a challenging start to the year, as expected; however, we remain well positioned to navigate this period of unprecedented disruption and continue to expect to drive significant market share gains in the second half of 2026,” said Gary S. Gillheeney, Sr., President, Chief Executive Officer, and Chair of the Board for Organogenesis. “We remain confident in the long-term opportunity for Organogenesis, supported by the largest, most comprehensive portfolio across multiple FDA classifications, a significant achievement with the ReNu BLA submission, and an ever-expanding body of clinical evidence.” First Quarter 2026 Financial Results: Net product revenue for the first quarter of 2026 was $36.3 million, compared to $86.7 million for the first quarter of 2025, a decrease of $50.4 million, or 58%. The decrease in net product revenue was driven by a decrease of $50.4 million, or 63%, in net product revenue for Advanced Wound Care products. Gross profit for the first quarter of 2026 was $10.5 million, or 29% of net product revenue, compared to $63.0 million, or 73% of net product revenue for the first quarter of 2025, a decrease of $52.5 million, or 83%. Operating expenses for the first quarter of 2026 were $106.1 million compared to $113.4 million for the first quarter of 2025, a decrease of $7.3 million, or 6%. Cost of goods sold was $25.8 million for the first quarter of 2026, compared to $23.7 million for the first quarter of 2025, an increase of $2.0 million, or 9%. Selling, general and administrative expenses were $65.2 million for the first quarter of 2026, compared to $72.5 million for the first quarter of 2025, a decrease of $7.3 million, or 10%. R&D expense was $15.2 million for the first quarter of 2026, compared to $10.6 million for the first quarter of 2025, an increase of $4.5 million, or 42%. For the three months ended March 31, 2025, the Company recorded write-down expenses of $6.6 million. Operating loss for the first quarter of 2026 was $68.9 million, compared to an operating loss of $26.7 million for the first quarter of 2025, an increase in operating loss of $42.1 million. Total other income, net, for the first quarter of 2026 was $0.4 million, compared to $1.0 million for the first quarter of 2025, a decrease of $0.5 million. Net loss for the first quarter of 2026 was $53.2 million, or $(0.44) per share, compared to net loss of $18.8 million, or $(0.17) per share, for the first quarter of 2025, an increase in net loss of $34.3 million, or $(0.27) per share. Adjusted net loss was $43.7 million for the first quarter of 2026, compared to adjusted net loss of $13.4 million for the first quarter of 2025, an increase in adjusted net loss of $30.3 million. Adjusted EBITDA loss was $48.2 million for the first quarter of 2026, compared to Adjusted EBITDA loss of $12.5 million for the first quarter of 2025, an increase in adjusted EBITDA loss of $35.6 million. Non-GAAP operating loss was $56.0 million for the first quarter of 2026, compared to non-GAAP operating loss of $19.3 million for the first quarter of 2025, an increase in non-GAAP operating loss of $36.7 million. 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. Fiscal Year 2026 Outlook: For the year ending December 31, 2026, the Company now expects: Total net revenue between $270.0 million and $310.0 million, representing a decline in the range of 45% to 52%, as compared to total net revenue of $564.2 million for the year ended December 31, 2025. The 2026 total net revenue guidance range assumes a sequential improvement in revenue trends in the second quarter, however, at a more measured rate versus what the prior guidance assumed resulting in a first half revenue decline in the range of approximately 52% to 49% year over year. We continue to expect strong sequential revenue growth in the third and fourth quarters of 2026, however, the low-end of the 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. First Quarter Earnings Conference Call: Management will host a conference call at 5:00 p.m. Eastern Time on May 7th to discuss the results of the quarter, and to provide a corporate update with a question and answer session. Those who would like to participate may access the live webcast here, or access the teleconference here. The live webcast can also be accessed via the company’s website at investors.organogenesis.com. The webcast will be archived on the company website for approximately one year. Non-GAAP Financial Measures Our management uses financial measures that are not in accordance with generally accepted accounting principles in the United States, or GAAP, in addition to financial measures in accordance with GAAP to evaluate our operating results. These non-GAAP financial measures should be considered supplemental to, and not a substitute for, our reported financial results prepared in accordance with GAAP. Our management uses Adjusted EBITDA, adjusted net income (loss) and non-GAAP operating income (loss) to evaluate our operating performance and trends and make planning decisions. Our management believes Adjusted EBITDA, adjusted net income (loss) and non-GAAP operating income (loss) help identify underlying trends in our business that could otherwise be masked by the effect of the items that we exclude. Accordingly, we believe that Adjusted EBITDA, adjusted net income (loss) and non-GAAP operating income (loss) provide useful information to investors and others in understanding and evaluating our operating results, enhancing the overall understanding of our past performance and prospects, and allowing for greater transparency with respect to key financial metrics used by our management in its financial and operational decision-making. Adjusted EBITDA Adjusted EBITDA consists of GAAP net loss excluding: (i) interest (income) expense, net, (ii) income tax (benefit), (iii) depreciation and amortization, (iv) amortization of intangible assets, (v) stock-based compensation expense, and (vi) additional infrequently occurring adjustments described in more detail below. The following table presents a reconciliation of GAAP net loss to non-GAAP EBITDA and non-GAAP Adjusted EBITDA, for the periods presented: Adjusted Net Loss Adjusted net loss is defined as GAAP net loss plus (i) amortization of intangible assets and (ii) additional infrequently occurring adjustments described in more detail below, less the estimated tax on these adjustments. The following table presents a reconciliation of GAAP net loss to non-GAAP adjusted net loss, for the periods presented: Non-GAAP Operating Loss Non-GAAP operating loss is defined as GAAP loss from operations plus (i) amortization of intangible assets and (ii) additional infrequently occurring adjustments described in more detail below. The following table presents a reconciliation of GAAP net loss from operations to non-GAAP operating loss, for the periods presented: Forward-Looking Statements This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements relate to expectations or forecasts of future events. Forward-looking statements may be identified by the use of words such as “forecast,” “intend,” “seek,” “target,” “anticipate,” “believe,” “expect,” “estimate,” “plan,” “outlook,” and “project” and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. Such forward-looking statements include statements relating to the Company’s expected revenue, competitive positioning and long-term opportunities. Forward-looking statements with respect to the operations of the Company, strategies, prospects, and other aspects of the business of the Company are based on current expectations that are subject to known and unknown risks and uncertainties, which could cause actual results or outcomes to differ materially from expectations expressed or implied by such forward-looking statements. These factors include, but are not limited to: (1) the impact of any changes to the coverage and reimbursement levels for the Company’s products, particularly in light of CMS’ updated 2026 Medicare reimbursement and coverage changes; (2) the Company faces significant and continuing competition, which could adversely affect its business, results of operations and financial condition; (3) rapid technological change could cause the Company’s products to become obsolete and if the Company does not enhance its product offerings through its research and development efforts, it may be unable to effectively compete; (4) to be commercially successful, the Company must convince physicians that its products are safe and effective alternatives to existing treatments and that its products should be used in their procedures; (5) the Company’s ability to raise funds to expand its business; (6) the Company has incurred losses in the prior periods and may incur losses in the future; (7) changes in applicable laws or regulations; (8) the possibility that the Company may be adversely affected by other economic, business, and/or competitive factors; (9) the Company’s ability to maintain production or obtain supply of its products in sufficient quantities to meet demand; (10) the Company’s ability to build out its Smithfield, Rhode Island facility on time and on budget; (11) whether the Company is able to obtain regulatory approval for and successfully commercialize ReNu; and (12) other risks and uncertainties described in the Company’s filings with the Securities and Exchange Commission, including Item 1A (Risk Factors) of the Company’s Form 10-K for the year ended December 31, 2025 and its subsequently filed periodic 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. About Organogenesis Holdings Inc. Organogenesis Holdings Inc. is a leading regenerative medicine and tissue innovations company focused on empowering healing through the development, manufacture, and sale of solutions for the Advanced Wound Care and Surgical & Sports Medicine markets. Organogenesis offers a comprehensive portfolio of innovative regenerative products to address patient needs across the continuum of care. For more information, visit www.organogenesis.com. CONTACT: Investor Inquiries: ICR Healthcare Mike Piccinino, CFA [email protected] Press and Media Inquiries: Organogenesis [email protected]

Interested in Organogenesis? Here are five stocks we like better. Organogenesis reported Q1 net product revenue of $36.3M, down 58% year‑over‑year (advanced wound care down 63%), which management attributes to market disruption and clinician confusion after CMS withdrew local coverage determinations and issued controversial "wastage" commentary. Management cut 2026 revenue guidance to $270–$310M (a 45–52% decline), completed a March restructuring (88 job cuts and a facility closure) targeting about $14M in annualized savings, and expects measured sequential improvement with positive adjusted EBITDA in the second half. As longer‑term positives, the company completed its ReNu BLA submission and reported a positive randomized trial for PuraPly AM in diabetic foot ulcers; Organogenesis also holds about $92.1M in cash with up to $75M of revolver availability. Organogenesis (NASDAQ:ORGO) reported a sharp year-over-year revenue decline in the first quarter of 2026, with executives pointing to significant disruption in the skin substitute market following Medicare policy changes and related commentary from the Centers for Medicare & Medicaid Services (CMS). President, CEO, and Chair Gary S. Gillheeney Sr. said first-quarter performance “reflect[s] the significant challenges in the operating environment” discussed on the company’s prior call. Net revenue fell 58% year-over-year, driven by a 63% drop in advanced wound care sales, while surgical and sports medicine revenue was flat. → Insider Sales: Top AST SpaceMobile Insider Cuts Postion Over 30% Gillheeney said clinicians faced “confusion and material disruption in the market” after the withdrawal of local coverage determination (LCD) policies for skin substitutes announced on Dec. 24 and CMS commentary on discarded product issued Dec. 30. He characterized CMS’s wastage commentary as “material but transient” for 2026 revenue trends, but said the impact on patient care could be longer lasting, arguing reduced use of PMA-approved products can expose patients to “preventable complications, infections, amputations, and potentially fatal outcomes.” During Q&A, Gillheeney added that the reimbursement transition was more complex than expected, citing “two sites of care with complete changes in the reimbursement model” and changes to reimbursement by product. He also highlighted issues related to “WISeR,” saying the company encountered technology challenges in states where prior authorization is required, as well as claim-processing problems at a “large MAC” that struggled “the entire first quarter,” with March claims only recently beginning to process. He said customers must rebill for January and February. → Light Speed Returns: Corning Cashes In on NVIDIA Growth Gillheeney said Organogenesis is engaging with CMS but does not have “direct clarity” on when the agency might clarify its wastage comments. He said the company’s objective is either an exemption for PMA products “because of all of the confusion around the handling and the billing and usage of a biologic, like our product Apligraf,” or clearer guidance. “There’s been no instructions or clarity on exactly what… their wastage policy is,” he said. Chief Financial Officer Dave Francisco reported net product revenue of $36.3 million, down 58% year-over-year. Advanced wound care net product revenue was $29.5 million, down 63%, and surgical and sports medicine net product revenue was $6.8 million, flat year-over-year. Total revenue included $1 million of income tied to a grant from the Rhode Island Life Science Hub, which Francisco said offset employee-related costs at the company’s Smithfield facility. → Years in the Making, AMD’s Upside Movement Has Just Begun Gross profit was $10.5 million, or 29% of net product revenue, compared to 73% in the prior-year period. Francisco attributed part of the pressure to inventory write-downs, including $4.3 million of adjustments for excess and obsolete inventory tied to a facility closure ($1 million) and LCD regulatory changes ($3.3 million). Excluding those write-downs, he said non-GAAP gross profit was $14.8 million, or 41% of net product revenue. Operating expenses were $106.1 million, down from $113.4 million a year earlier. Excluding cost of goods sold, non-GAAP operating expenses were $80.3 million compared to $89.7 million, a 10% decline. Francisco said the change reflected a $7.3 million decrease in SG&A and a $6.6 million write-down of certain non-recurring expenses that impacted the first quarter of 2025, partially offset by a $4.5 million increase in R&D expense. Organogenesis posted an operating loss of $68.9 million, compared to an operating loss of $26.7 million in the prior-year quarter. On a non-GAAP basis, operating loss was $56.0 million versus $19.3 million. GAAP net loss was $53.2 million compared to $18.8 million, while net loss to common stockholders was $56.2 million, which Francisco said reflected the cumulative dividend and non-cash appreciation to redemption value of convertible preferred stock. Adjusted net loss was $43.7 million versus $13.4 million, and adjusted EBITDA loss was $48.2 million versus $12.5 million. With the recovery now expected to take longer, Gillheeney said the company completed a restructuring in March that included a workforce reduction of 88 employees and the closure of operations at its St. Petersburg, Florida facility. He said the actions are expected to produce about $14 million in annualized cost reductions. As of March 31, 2026, Francisco said Organogenesis had $92.1 million in cash, cash equivalents, and restricted cash, with no outstanding debt, compared to $94.3 million at the end of 2025. He also cited “working capital availability under a revolving facility of up to $75 million.” Management lowered its full-year 2026 revenue outlook, citing a “more measured improvement in clinician confusion and overall operating environment” than previously anticipated. Francisco said the company now expects total net revenue of $270 million to $310 million in 2026, representing a 45% to 52% year-over-year decline. Previously, the company’s guidance assumed a decline in the range of 25% to 38%. Francisco said the revision primarily reflects updated assumptions for advanced wound care sales. While the company continues to expect sequential improvement in the second quarter, he said the pace is expected to be more measured, and the updated view implies first-half revenue declining approximately 49% to 52% year-over-year. He said the company continues to expect “strong sequential revenue growth in both the third and fourth quarters of 2026,” while the low end of guidance assumes a more prolonged recovery with second-half revenue declines similar to the first half. On profitability, Francisco said the company’s updated outlook still assumes improved adjusted EBITDA performance sequentially and positive adjusted EBITDA generation in the second half. To help protect profitability and cash flow, the company now expects to reduce operating expenses excluding cost of goods sold by about 25% year-over-year in 2026, including more than 30% in the second half. He said these assumptions include approximately $7 million of estimated cost savings in the third and fourth quarters tied to the restructuring. In response to an analyst question about confidence in a back-half recovery, management pointed to month-over-month improvement within the first quarter that continued into April, along with expectations that “customer confusion should abate” and that “competition dynamics will be quite a bit different” later in the year. Gillheeney highlighted two recent developments the company views as important to its longer-term strategy. He said Organogenesis completed its biologics license application (BLA) submission for ReNu on April 28, describing it as a milestone for a regenerative therapy aimed at symptomatic knee osteoarthritis. He said the company began a rolling BLA submission in December 2025 with nonclinical modules and completed the application with submission of the clinical and chemistry, manufacturing, and controls modules. Gillheeney also cited clinical results for PuraPly AM. He said the company announced completion of a randomized controlled trial on April 6 evaluating PuraPly AM plus standard of care versus standard of care alone in non-healing diabetic foot ulcers. The prospective multicenter trial enrolled 170 patients and 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. Gillheeney said the company believes publication of the results will support inclusion in future coverage policies. In closing remarks, Gillheeney said the operating environment is expected to remain difficult through the first nine months of 2026, with sequential revenue improvement through the year and a return to “more normalized profitability” in the fourth quarter. Organogenesis Inc operates as a regenerative medicine company focused on the development, manufacturing and commercialization of therapeutic solutions for wound care, surgical repair and sports medicine. The company's product portfolio addresses a range of acute and chronic tissue repair needs, leveraging bioengineered skin substitutes, human placental-derived products and other allografts designed to promote healing and reduce scarring. Organogenesis markets its therapies to hospitals, outpatient clinics, wound care centers and other healthcare providers. Key offerings include Apligraf, a living skin substitute for treatment of diabetic foot ulcers and venous leg ulcers; Dermagraft, a cryopreserved human fibroblast-derived dermal substitute; Grafix, a placental membrane allograft for complex and chronic wounds; and TheraSkin, a cryopreserved human skin allograft used in surgical and reconstructive procedures. The article "Organogenesis Q1 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for May 2026.

Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Management attributed the 58% revenue decline to a massive 63% contraction in the skin substitute market following CMS commentary on discarded products and reimbursement policy changes. The December 30 CMS comments regarding product wastage caused significant clinician confusion, leading some providers to move away from skin substitutes entirely to avoid perceived audit risks. Despite the revenue drop, the company believes it enhanced its market share position as unit volume outperformed broader industry declines. Operational performance was further hampered by technical issues with the WISeR system and a major Medicare Administrative Contractor (MAC) that struggled to process claims throughout the first quarter. The company executed a strategic restructuring in March, reducing its workforce by 88 employees and closing a Florida facility to align its cost structure with the current revenue environment. Management emphasized that while the market disruption is material, they view it as a transient headwind that will abate as clinicians gain comfort with new billing protocols. The updated 2026 revenue guidance assumes a more measured and prolonged recovery, with market-related headwinds expected to persist through the first nine months of the year. Management expects a return to normalized profitability in the fourth quarter of 2026, driven by sequential revenue improvements and the realization of $14 million in annualized cost savings. The company anticipates significant market share gains in the second half of 2026 as competitive dynamics shift and the largest, most comprehensive portfolio in the industry provides a stability advantage. The BLA submission for ReNu, completed in April 2026, is a key strategic pillar intended to transition the company into the symptomatic knee osteoarthritis market. Future coverage policies are expected to be increasingly evidence-based, with the company positioning its recent PuraPly AM clinical trial success as a critical tool for maintaining preferred status. First quarter gross margin was significantly impacted by $4.3 million in inventory write-downs related to facility closures and regulatory changes. The company flagged increased uncertainty regarding the timing of a formal CMS resolution or clarification on wastage policies since the previous earnings call. A $1 million grant from the Rhode Island Life Sciences Hub was recognized as income, partially offsetting employee-related costs at the Smithfield facility. Management warned that the current market disruption is causing enduring harm to patients by delaying access to clinically validated PMA-approved products. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. Management explained that the complexity of the reimbursement change was higher than anticipated, involving two sites of care and simultaneous changes to payment models and product rates. Technical failures in the WISeR pre-authorization system and MAC processing delays for January and February claims were unforeseen factors that exacerbated the downturn. The company has no direct clarity on when CMS will provide an update but continues to lobby for an exemption for PMA-approved products due to their unique handling requirements. In the absence of agency guidance, the company is focusing on providing its own clarity to customers to rebuild confidence in utilizing Apligraf. Management noted that they have observed month-over-month improvements in the first quarter that have continued into April. The recovery thesis relies on the abatement of customer confusion and a belief that the competitive landscape will be more favorable as smaller players struggle with the new regulatory environment.