Organogenesis Holdings Inc. (ORGO) Earnings Call Transcript & Summary

Welcome, ladies and gentlemen, to the First Quarter 2025 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 those as non-GAAP financial measures. Reconciliations of those non-GAAP financial measures to the most comparable measures calculated and presented in accordance with GAAP are available in the earnings press release on the Investor Relations portion of our website. I would now like to turn the call over to Mr. Gary S. Gillheeney, Sr., Organogenesis Holdings President, Chief Executive Officer and Chief of the Board. Please go ahead.

Thank you, operator, and welcome, everyone, to Organogenesis Holdings First Quarter 2025 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 operating and strategic 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 guidance for 2025, which we reaffirmed in our press release this afternoon. Then we'll open it up for questions. Beginning with a review of our revenue results in Q1, we delivered sales in line with our guidance range outlined on our fourth quarter call. Our first quarter results reflected the expected disruption in customer demand and ordering patterns given the continued uncertainty related to the effective date of the final LCD for skin substitute grafts and cellular/tissue-based products for the treatment of DFU and VLU. Rumors of further delays in the effective date in late March added additional ambiguity and disruption in customer behavior, but we are proud of the team's execution in a challenging environment during the first quarter. They remained focused on ensuring our customers were both informed and well positioned to continue to treat patients with our full portfolio of [ highly ] efficacious products. This process and this focus proved to be even more valuable in the weeks leading up to CMS' stated effective date of April 13, 2025, and in the weeks following the announcement of the third delay in the implementation of the LCD until January 1, 2026. Organogenesis supports CMS' decision to delay the LCD implementation to review its coverage policies. As mentioned on previous earnings calls, we applaud the CMS and MACs for continuing to prioritize coverage with demonstrated clinical efficacy for skin substitute products. And we've been pushing for reform for many years and believe the LCD represented a substantial step forward towards cleaning up the market and providing access to all who need care. Importantly, we continue to believe that patients should have access to products with high-quality evidence of effectiveness that includes real-world evidence. We believe real-world evidence not only demonstrates a product safety and efficacy but also outcomes in the actual clinical use. Studies that use real-world evidence are important because they provide affirmative data demonstrating the safety and effectiveness of medical interventions in everyday settings, leading to more informed clinical decision-making. They also allow for larger sample sizes, more sites as well as the ability to include more patients with a profile similar to the Medicare population as compared to an RCT. That said, we continue to believe that coverage policy alone are not sufficient to address the rapidly escalating Medicare cost while ensuring cost-effective patient care and innovation. To that end, we recommend that CMS implement an integrated coverage and payment policy. And as a leader in the space, we will continue to bring stakeholders together to develop an advocate for such an integrated policy that will ensure patient access to the most appropriate products while achieving significant cost savings to Medicare. While we were prepared to execute our strategy in a post-LCD environment, following the CMS announcement on April 11, we quickly pivoted to maximize our substantial competitive advantages during the period of extended LCD delay. Organogenesis' strong brand equity, diverse portfolio and deep customer relationships have us well positioned to navigate a challenging market. And we are encouraged by the early progress in our team's broad-based efforts to engage with our customers to ensure our full portfolio of products are available and approved in their healing algorithms and formularies. We have reaffirmed our financial guidance for 2025 and are confident in the team's ability to execute our commercial strategy this year. Importantly, we remain confident in the long-term opportunity for Organogenesis as well. We continue to believe the material changes from the MACs in the coverage of skin substitutes to be implemented in 2026 represents an enormous opportunity for Organogenesis to serve more patients and importantly will be positive for the long-term health of the wound care market. We are aggressively pursuing our strategy to secure and submit additional clinical and real-world evidence to the MACs by the newly established deadline of November 1, 2025, and expect to submit a compelling case to secure coverage for PuraPly AM when the LCDs are implemented in 2026. We expect to remain 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. Now before turning the call over to Dave, I wanted to provide a brief update on a key area of strategic focus for our company. 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. With respect to our ReNu program, we remain on plan and continue to expect that all patients will complete the second Phase III study by the end of the second quarter. We expect to complete the initial statistical analysis and have top line data results from the second Phase III study to share publicly in September of this year. Our time line continues to target completion of the final clinical study report required for the modular BLA submission in the fourth quarter, which has us on track for a BLA submission by the end of this year. We continue to believe, if approved, introducing ReNu to a large and growing pain management market represents a transformational opportunity for Organogenesis. We believe ReNu, if approved, will potentially address an unmet medical need for all patients suffering from symptomatic knee OA, a degenerative joint disease that affects more than 30 million Americans. And we have a clear road map and time line for our ReNu BLA submission. And if successful, ReNu would be the only FDA-approved biologic intra-articular injection to improve pain symptoms related to symptomatic knee OA. Respect to our recent progress in expanding our clinical validation of our wound care solutions, our [ PREPARE ] study evaluating PuraPly AM plus standard of care versus standard of care alone continues to progress. We initiated enrollment of up to 170 patients with chronic DFUs last August and have enrolled more than 60 patients to date. We accelerated investigator site activation during the quarter and expect to complete an interim analysis in the third quarter. Our RCT evaluating Affinity for patients with VLU completed last patient, last visit for the initial patient cohort in Q1, and we are currently engaged in data monitoring and management activities. We expect to initiate new RCTs evaluating NuShield for patients with VLU and Novachor for patients with Mohs surgical excision wounds in the third quarter of 2025 and the first quarter of 2026, respectively. We continue to invest in generating clinical data for our existing products and pipeline products and believe such data enhances sales efforts with physicians and reimbursement dynamics with payers over time. And finally, we are pleased with the significant progress we've made in our efforts to expand our manufacturing capabilities, efficiencies and capacity with our newly leased biomanufacturing facility in Smithfield, Rhode Island. Upon completion, this new facility will support the reintroduction of both Dermagraft and TransCyte. TransCyte is a bioengineered cellular tissue scaffold that promotes burn healing and has received PMA approval for the treatment of deep second- and third-degree burns. This new facility will also support the introduction of FortiShield, a biosynthetic transitional wound matrix for second degree burns. Together, we believe these new products and the expansion of our manufacturing capacity overall will enhance our long-term growth and margin profile. With that, let me turn the call over to Dave.

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 revenue for the first quarter was $86.7 million, down 21%. As Gary mentioned, these results were in line with the expectations we provided on our Q4 call, which called for total revenue in a range of $85 million to $95 million. Our Advanced Wound Care net revenue for the first quarter was $79.9 million, down 23%. Net revenue from Surgical & Sports Medicine products for the first quarter was $6.8 million, up 11%. Gross profit for the first quarter was $63 million or 72.6% of net revenue compared to 73.9% last year. Gross profit was unfavorably impacted in the period due primarily from lower revenue over our fixed costs as well as the expiration of excess product resulting from the delayed implementation of the LCD and related uncertainty. Operating expenses for the first quarter were $89.7 million compared to $85.1 million last year, an increase of $4.6 million or 5%. The year-over-year change in operating expenses was driven by a $6.6 million write-down of cost to adjust certain assets held for sale to their fair market value, offset partially by a $2.2 million reduction in research and development expenses, which declined 17% year-over-year due to the timing of expenses associated with clinical research and trials. SG&A expenses were essentially flat year-over-year as continued investments in our key long-term projects were offset by lower commissions and our focus on managing discretionary expenses in the period. Operating loss for the first quarter was $26.7 million compared to an operating loss of $3.9 million last year, an increase of $22.9 million. Excluding noncash amortization expenses in both periods and the write-down of assets held for sale in the quarter, our non-GAAP operating loss was $19.3 million compared to $3 million last year. GAAP net loss for the first quarter was $18.8 million compared to a net loss of $2.1 million last year, an increase of $16.7 million. Net loss to common for the first quarter was $21.6 million compared to a net loss of $2.1 million last year. Net loss to common includes both the impact of the cumulative dividend and the noncash accretion to redemption value on our convertible preferred stock. Adjusted EBITDA loss for the first quarter was $12.5 million compared to adjusted EBITDA of $2.6 million last year. And turning to the balance sheet. As of March 31, 2025, the company had $110.5 million in cash, cash equivalents and restricted cash with no outstanding debt obligations. And that compared to $136 million in cash, cash equivalents and restricted cash with no outstanding debt obligations as of December 31, 2024. We expect to see improving cash performance over the balance of 2025 and believe we have the requisite capital to execute our growth strategies with $110.5 million in cash, cash equivalents and restricted cash and $125 million available for future revolving borrowings under our revolving facility. Turning to a review of our 2025 revenue guidance, which we reaffirmed this afternoon's press release. For 12 months ending December 31, 2025, the company continues to expect net revenue of between $480 million and $535 million, representing a year-over-year change in the range of roughly flat to an increase of 11%. The 2025 net revenue guidance range continues to assume net revenue from Advanced Wound Care products of between $450 million and $500 million, representing a year-over-year change in the range of a decline of 1% to an increase of 10%; net revenues from Surgical & Sports Medicine products of between $30 million and $35 million, representing a year-over-year increase in the range of 6% to 23%. With respect to our profitability and EBITDA guidance, the company now expects GAAP net income in the range of $4.7 million to $34 million compared to $9.5 million and $38.8 million previously; EBITDA in the range of $20 million to $59.6 million compared to $27 million to $66.6 million previously; non-GAAP adjusted net income in the range of $15.3 million to $44.6 million, unchanged versus our prior guidance; and adjusted EBITDA in the range of $43.6 million to $83.2 million, again, unchanged versus our prior guidance. In addition to our formal financial guidance for 2025, we are providing some considerations for modeling purposes. We continue to expect the environment to be very challenging through the first half of 2025, followed by a significant improvement in our business trends beginning in the third quarter. For modeling purposes, we expect the second quarter revenue in the range of approximately $100 million to $110 million. Our profitability guidance for 2025 now assumes gross margin in the range of approximately 78% to 79% compared to 76% to 78% previously, GAAP operating expenses up low single digits year-over-year and excluding noncash intangible amortization of approximately $3.3 million, the nonrecurring FDA payment related to our BLA filing of $4.6 million and the $6.6 million write-down of assets in Q1. Our total non-GAAP operating expenses will increase approximately 5% to 7% year-over-year. There are no material changes to the other modeling assumptions for 2025 we outlined in our fourth quarter call. With that, I'll turn the call over to the operator to open up the call for your questions.

[Operator Instructions] And our first question will come from Brooks O'Neil of Lake Street Capital Markets.

This is Aaron on the line for Brooks. Just curious maybe about the cadence as we move throughout the year, understanding the back half being more weighted, but -- and also there's some still uncertainty out there. But maybe just more curious about some of the key puts and takes that are embedded within the guidance and maybe what you're most confident with moving forward.

Yes, sure, Aaron. This is Dave. So look, we're very confident in our prior guide. I think what we've illustrated here is we have a lot of optionality in our portfolio given the uncertainty that we saw in 2024 regarding the reimbursement landscape that we see now. So we're pretty excited about that opportunity. We have all the tools, products and people that we need to execute against that initiative that we've got this year. So I'd say, look, from the last time we guided, there was a significant change in the market environment. But nonetheless, we've reaffirmed our guidance on the top line and the bottom line. And I think the big piece there is we've got a situation where PuraPly is now available across the full healing algorithms, so all indications, inclusive of DFU and VLU. We've got the full portfolio beyond PuraPly as well for all indications. And we see in the back half a stabilization of the market and customer buying behavior. The offset to that to some extent that gets us to the same level is, obviously, we've got a situation where we've got to get those products back on to formularies. The competition remains in a push-off of the LCD that's been challenging for us in the past, but obviously, we executed very, very well in 2024. And there is some uncertainty that remains probably in the back half of the fourth quarter of this year as well. So we're also seeing some high-ASP entrants still continue to enter the market as well. So those are the kinds of puts and takes that I see from the overall guidance perspective.

Right. Okay. That makes sense. Appreciate that. And maybe just a little bit more color on the gross margin. I appreciate again the guidance there at the end of the call. But is there anything we should be thinking about as far as based on your typical historical margin sort of sequential growth? Or just maybe any more color there would be fantastic.

Yes, sure. So similar to the revenue, it should be back-end loaded. And the issue there is that we've got -- just based on the dynamics of the marketplace, we've got a major mix shift in the product portfolio. And I also mentioned that we had excess inventory in our living technology that expired in the first quarter. Some of that will spill into the second quarter as well. We don't expect that to repeat in the second half. And that's all related to delays in the LCD as we really -- obviously, the living technology was on the covered list. And therefore -- we have a 6-week lead time for the demand pull for those products. And so obviously, it had some extra expiry that we saw in the first quarter and expect that to continue into the second quarter as well. So a big jump up in gross margin overall based on that mix shift and the lack of expiry going forward.

Our next question will be coming from Ryan Zimmerman of BTIG.

In the fourth quarter, you had a really strong performance. And I kind of think about the environment at that time in the market with some of the uncertainty. At the time, we thought the LCD was coming. And so you saw buying patterns that were really strong for you and maybe not so much for those companies that were not included on the covered list. I guess I'm curious why that didn't follow a similar pattern this quarter given kind of going into the first quarter, again, the LCD is now delayed a second time at this point before the third delay, and I would have expected kind of a similar dynamic. So I'm curious, Gary, what you can say about kind of why that didn't follow a similar pattern this quarter.

Yes. Sure, Ryan. So when you look at the fourth quarter, we didn't see much of a change until the end of December, and we did start to see some softening at the end of the year with the confusion setting in. So that really did happen at the end of December, and then it continued to perpetuate in January. So a lot of the financial buyers were continuing to buy high-ASP products until such time as the LCD drops. There was a lot of caution and a little contraction in the market that we've seen in the first quarter that we hadn't seen in the fourth quarter last year. And that contraction, which we believe is temporary, has a lot to do with the confusion and also all the audits that are going on in the field right now, particularly for our customers. So the dynamics were a little different, and -- but we've pivoted and we're -- with our portfolio. We have the optionality to do extremely well with the LCD or with our optionality without the LCD.

Very fair, Gary. That's helpful color. I guess as you think about the -- getting back on the same question, the pacing dynamics, I guess I'm curious why the second quarter now would have maybe still a slowdown relative to the back half of the year and what makes the back half of the year normal in the face of the LCDs now occurring Jan 1, 2026, in your guys' view.

Well, the first delay, which was, I guess, 60 days, there really was confusion assuming that this thing was going to drop. Now you've got it basically pushed off almost 9 months. So we're now getting our customers back and our products back on formularies like PuraPly and others for DFU and VLU. So that takes time. If you recall, when we had this issue at least back in '23, it took us maybe 3 months to get everybody back on formulary. We're actually seeing a better trend right now. But that trend of getting folks back, we still saw in Q2 -- excuse me, in Q1.

Okay. That's very helpful. And then stepping back for a second, just given the effort that has occurred over the year -- in years past with corralling cost in the wound care market, it seems like -- again, we want to -- Medicare wants to get this right, having -- trying to read through the tea leaves here. But at the same time, it's being held off until 2026. So what in your mind is going to change? Or what are you hearing from CMS in terms of why they're holding off? And what may change between now and early 2026, if you have any thoughts, Gary?

Sure. It's a great question. So we think that CMS is now heavily involved in driving this process. And I think they were pretty clear in their press release that they're reviewing the coverage policies that exist today in the MACs. So that's encouraging. They're going to look at the data. They are offering time to get more data. They've indicated that where products may have big impacts in the market and could be left off or there are gaps in the market that those types of products would be looked at. So I think it's not just a delay, which if it was delayed in its current form, that would not be a good thing, but the fact that it's delay to reevaluate the data and look for additional data as well as giving you more time to provide the data, we think it just expands the number of products, and we think that's extremely positive for our PuraPly AM product for sure that it has the ability to get -- and we do expect with the additional data that we'll be filing that PuraPly AM will be on the approved list. That's our belief right now, and that's how we view this. So I think that's one reason for the delay. The second is, as you know, we believe payment is a big part of the solution here. And we think CMS is aggressively looking at payment. We don't know if we'll see anything in July in the proposed rule. But if there is no payment solution, there needs to be something to baffle the cost and slow down spending, and that would be the LCD that's available to them on January 1. So I think they're expanding the LCD. So it's more impactful to patients, meaning more products, more accessibility. But at the same time, it's a backstop. If payment doesn't happen and then they have no LCD, then it's basically where we are today, which is not a good place. So I don't know if that's helpful, Ryan, but that's my view.

No, no, that's -- very appreciative. And it sounds like there's a range of options, maybe more so than what we saw in the original LCDs that could come out of this kind of come early January 2026, and maybe we are having that discussion around either new payment models or so forth. But yes, we'll have to see. I appreciate the color.

[Operator Instructions] And our next question will be coming from Ross Osborn of Cantor Fitzgerald.

Starting off, and I apologize for going back to guidance, but if I remember the commentary correctly for this year, guidance that you reiterated today assumed a strong inflection point in the second half of the year due to the LCD coming through. So could you disclose, I guess, one more time, why you think you can still hit your prior guidance given the fact that the LCD is obviously not going through?

Ross, I'm sorry, but it was very difficult to understand what you said. We can hear you loud and clear, but it's a little garbled.

Is this better now?

Yes.

Yes, that's much better. Great.

Okay. Great. So I was just asking about guidance, and sorry to hone on this topic, but based upon your original guidance and your commentary, it assumed a strong inflection in the second half of the year given that the LCD would go through. I'm just still a little bit confused why you guys were able to reiterate guidance given that it won't go through. So just curious what the uplift in the revenue is at this point.

Yes, sure. So what I indicated a little bit earlier was the benefits that we've got is PuraPly is now available for all indications. And obviously, that's a huge win for us. We've got the full portfolio of products as well, which PuraPly and some of the licensed products are higher-margin products. So obviously, that helps gross margin as well as well as the top line. And so we see continued stabilization of the market and customer buying behaviors in the back half. And so those all coupled together, we think, are really beneficial for us overall. The offset to that, of course, is that, as Gary mentioned, it takes time to bring the products back on to the formularies. The competition dynamics are still the same as they were in '24, which, again, we were successful in that year. But remember, we had assumed post-LCD, we'd have 3 commercialized products out of 18 for DFUs and VLUs. That doesn't exist anymore. The competition is still there. There's still some uncertainty, and we assume there's some offsets to the benefit in the late part of Q4, just like we saw in Q1.

So if you think about it, under the LCD that we had fewer products on the LCD, so the forecast is built on volume moving to those products. Now we have the breadth of our portfolio, as Dave said, which is much broader, and we do have higher-margin products in our portfolio. So you're replacing a few products with a lot of volume with a number of products with higher margins. So that offset basically is volume versus price. That's the magic of our portfolio. The optionality that we have and the flexibility we have to be able to pivot and move to different products at different pricings and different sites of care is what allows us to continue to reinforce guidance, and we're confident in the guidance.

Understood, and that's helpful. And then stabilization is an interesting word obviously given all the market dynamics. Could you just expand on that a little bit and why you think that will occur?

Yes, I'll start and David can jump in. So as we're educating our customers, we spent a lot of time engaging with our customers. There was confusion around which products were on the LCD or not and whether or not the non-DFU and VLU wounds could still be utilizing our products. So as that information gets in, we're seeing customers starting to go back to their old buying habits and their buying patterns as we get on formulary. So we think that's the stabilization, and there's no LCD impact at all for the rest of the year. So we think the combination of our education and the fact that the LCD is now pushed into another year is what the stabilization is based on.

Yes, I agree, Gary. I think the last announcement was on April 11. So obviously, we have some lingering impact in the second quarter, and we expect that to really be stable in the back half as people really understand the reimbursement landscape and get more comfortable in this market.

Understood. And then I guess last question for me, and I'll jump back in queue. Could you guys parse out volume versus pricing for the second half of this year, meaning are you planning on introducing higher-priced products to make up for potentially lost volume kind of playing the game of the companies on LCD?

Yes. So we're not introducing anything new necessarily. I mean we've obviously got new products periodically. But the reality is it's just the fact that, as Gary said and I think I mentioned as well, that we have the full portfolio at our disposal for DFUs and VLUs. So it really just is higher-margin products across some of the licensed products as well as our PuraPly franchise now is available for that fairly large subset of the market. So we can address all indications with the entire portfolio. So it's just a mix shift from only the covered products in that subset to the full portfolio.

And 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.

Thank you very much.