Organogenesis Holdings Inc. Price & Performance (ORGO)

We generally refer to these as non GAAP financial measures. Reconciliations of these 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. Goheenie, Senior Organogenesis Holdings' President Chief Financial Officer and Chair of the Board. Please go ahead, sir. Thank you, operator, and welcome everyone to Organogenesis Holdings' fourth quarter fiscal year twenty twenty four 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 fourth 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 fourth quarter financial results, our balance sheet and financial condition at quarter end, as well as our financial guidance for 2025. Which we introduced in our press release this afternoon, then we will open the call up for questions. Beginning with a review of our revenue results for Q4, we delivered sales results above the high end of the guidance range outlined on our third quarter call.

Growing 27% in the period. Our fourth quarter results reflect strong momentum in underlying business trends and customer demand in excess of what our guidance had assumed. As discussed in our recent investor calls, our our fourth quarter and fiscal year twenty twenty four guidance reflected the expectation that the final ruling from the MAX on the proposed LCDs would be announced in the fourth quarter with an effective date of 01/01/2025. [indiscernible] The LCD was finalized in the fourth quarter. However, the stated effective date of 02/12/2025 was later than we had assumed. We believe the stronger customer demand we experienced in the second half of the fourth quarter is a direct result of less disruption in the marketplace related to the delayed effective date for the final LCD ruling from the MAC. As mentioned on previous earnings calls, we applaud the MAX for continuing to prioritize coverage with demonstrated clinical efficacy for skin substitute products We have been pushing for reform for many years and believe the LCDs represent toward cleaning up the marketplace and providing access to all who need the care. That said, we continue to believe the MAX evidence based approach to coverage of skin substitute products should include both clinical and real world data.

Importantly, we continue to push for CMS to introduce the requisite changes to the payment policies for SCIM substitutes as well. As discussed on our last earnings call, we have communicated CMS that they should transition to a value based payment methodology where skin substitute categories are paid on a fixed per square centimeter basis. This value based payment methodology has the potential to substantially reduce Medicare Part B expenditures improve patient access, enable physicians to prescribe treatment options based on the individual needs of the patient and provide the best outcomes for patients in the healthcare system. As a leader in this market, we have been and will continue to actively engage with CMS to advocate for the requisite changes to the current system. We are proud of the team's strong execution in the fourth quarter They reacted quickly to the news of the delayed effective date and focused on ensuring our customers were both informed and well positioned to continue to treat our patients with our full portfolio of highly products. We believe the better than expected revenue results we delivered in the fourth quarter represent further evidence that Organogenesis' strong brand equity established commercial infrastructure and deep customer relationships taken together represent a substantial competitive advantage as we move through and navigate this uncertain market.

On 01/24/2025, the MAX announced the second delay in the implementation of the LCDs 2025. The news of this decision created additional ambiguity and disruption in customer behavior, which has resulted in a more challenging operating environment to date in 2025. Dave will discuss our guidance in more detail later on the call, but for now, I'll say that our team is focused on our targeted commercial strategy and on providing excellent service and support for our customers in this dynamic environment. We have introduced our financial guidance for 2025 assuming that the final LCD will be effective on April 13, 2025. As discussed on prior calls, when coverage and reimbursement changes are implemented, the business experiences disruption in demand and utilization trends as customers transition to the new policies. Based on the April 13, 2025 effective date, we expect the environment to continue to be challenging throughout the first half of twenty twenty five followed by an assumed stabilization in the market as such a significant improvement in our business trends beginning in the third quarter. We way of reminder, the LCDs as finalized in November of twenty twenty four only apply to DFU and VLU indications If the LCDs take effect as scheduled, a total of 18 products would remain covered including our Apolograph and DermaGraft products for both DFU and VLU and our Affinity InuShield products for DFU.

However, more than an estimated 200 products would be classified as non covered. We continue to believe these material changes from the MAX in the coverage of skin substitutes represents an enormous opportunity for Organogenesis to serve more patients and importantly will be a positive for the long term health of the wound care market. Before turning the call over to Dave, I wanted to provide a brief update on a key area of strategic focus for the company. We believe gathering robust and comprehensive clinical and real world outcomes data is essential in developing a competitive product portfolio and driving further penetration in the markets where we compete. We continue to invest in generating clinical data for our existing and pipeline and believe such data enhance sales efforts with physicians and reimbursement dynamics with payers over time. To that end, I'd like to share an update on our renew program as well as key clinical milestones for 2025. We completed the enrollment in our second Phase three prospective multicenter double blinded randomized saline controlled clinical trial to evaluate the efficacy of RHINO in patients with knee osteoarthritis in the second quarter of twenty twenty four. The study enrolled five ninety four randomized subjects with KL severity of two to four knee osteoarthritis.

We performed the pre specified interim analysis on fifty percent of the planned four seventy four subjects after six months of follow-up in the fourth quarter of twenty twenty four. The Data Monitoring Committee or DMC recommended the clinical trial proceed without modification without increase in sample size. The DMC also reviewed available safety data and found the safety data to be consistent with the known safety profile for ReNu. Regarding our next steps, we expect to have all patients completing the study by the end of the second quarter of twenty twenty five. We expect to complete the initial statistical analysis and have top line data results from the second Phase three study to share publicly in September of twenty twenty five.

Our current timeline targets completion of the final clinical study report required for the BLA submission in the fourth quarter which has us on track for a BLA submission by the end of twenty twenty five. And we continue to believe that if approved, introducing Renew to a large and growing pain management market represents a transformational opportunity for the company. We believe renew, if approved, will potentially address an unmet clinical need for all patients suffering from symptomatic NeoA. A degenerative joint disease that affects more than thirty million Americans, Today, we have a clear roadmap and timeline for our RENEW BLA submission and if successful, RENEW would be the only FDA approved biologic intraarticular injection to improve pain symptoms related to symptomatic knee osteoarthritis. With that, let me turn the call over to Dave. Thanks, Gary. I'll begin with a review of our fourth quarter financial results. And unless otherwise specified, all growth rates referenced during my prepared remarks are on a year over year basis. Net revenue for the fourth quarter was $126,700,000 up 27%. As Gary mentioned, these results were ahead of the expectations we provided on our Q3 call which called for a total fourth quarter revenue in the range of $100,000,000 to $125,000,000 Our Advanced Wound Care net revenue for the fourth quarter was $119,000,000 up 27% and net revenue from Surgical and Sports Medicine products for the fourth quarter was 8,000,000 up 24%.

Gross profit for the fourth quarter was $96,000,000 or 75.5% of net revenue, compared to 72.1% last year. Operating expenses for the fourth quarter were $85,400,000 compared to $73,200,000 last year an increase of $12,200,000 or 17%. This year over year change in operating expenses was driven by a $12,500,000 or 20% increase in selling, general and administrative expenses compared to the prior year period Research and development expenses declined 3% year over year, but increased 11% sequentially, due to the timing of expenses associated with clinical trials and research. Operating income for the fourth quarter was $10,200,000 compared to an operating loss $1,300,000 last year an increase of $11,500,000 GAAP net income for the fourth quarter was 7,700,000.0 compared to a net loss of $600,000 last year an increase of $8,300,000 and net income to common for the fourth quarter was $5,900,000 compared to a net loss of $600,000 last year. Net income to common includes the impact of both the cumulative dividend and the non cash accretion to redemption value on our convertible preferred stock. Adjusted EBITDA for the fourth quarter was $18,200,000 or 14.4% of net revenue compared to $7,500,000 or 7.5% of net revenue last year.

We're pleased with the financial results we delivered in the fourth quarter where we leveraged the better than expected revenue results to drive adjusted EBITDA that exceeded the high end of our guidance range by more than $2,000,000 Turning to a brief review of our financial results for the twelve months ended 12/31/2024. Net revenue was $482,000,000 compared to $433,100,000 for the year ended December 31, 2023, an increase of $48,900,000 or 11%. The increase in net revenue was driven by an increase $48,100,000 or 12% in the net revenue of Advanced Wound Care products an increase of $800,000 or 3% net revenue of Surgical and Sports Medicine products. Adjusted EBITDA was $49,800,000 or 10.3% of net revenue compared to adjusted EBITDA of $42,600,000 or 9.8% of net revenue the year ended December 3120 Turning to the balance sheet. As of 12/31/2024, the company had $136,200,000 of cash, cash equivalents and restricted cash, This compared to $104,300,000 in cash, cash equivalents and restricted cash in $66,200,000 in net debt obligations as of 12/31/2023. As discussed in our third quarter call, the private placement Series A convertible preferred stock to Avista Healthcare Partners in November 2024 provided important capital to execute our long term growth strategies and substantially enhanced our balance sheet and financial condition.

We used a portion of the $122,700,000 of net proceeds from this transaction to pay off the outstanding borrowings of 66,600,000.0 on our long term debt facility. We appreciate the support from a leading healthcare investor and believe it reflects Avista's confidence in the compelling opportunity investing in Organogenesis presents. [indiscernible] five financial guidance, which we introduced in this afternoon's press release. For the twelve months ended 12/31/2025, the company expects net revenue between $480,000,000 and $535,000,000 dollars representing year over year change in the range of a roughly flat to an increase of 11%. The 2025 net revenue guidance range assumes net revenue from a Advanced Wound Care products between $450,000,000 and $500,000,000 representing a year over year change in the range of a decline of 1% to an increase of 10%.

Net revenue from Surgical and Sports Medicine products of between $30,000,000 and $35,000,000 representing a year over year increase of 6% to 23%. With respect to our GAAP profitability and EBITDA guidance for the company, the company expects GAAP net income in a range of $9,500,000 to $38,800,000 EBITDA in a range of $27,000,000 to $66,600,000 non GAAP adjusted net income in the range of $15,300,000 to $44,600,000 and adjusted EBITDA in the range of $43,600,000 to $83,200,000 In addition to our formal financial guidance for 2025, we're providing some considerations for modeling purposes. As Gary mentioned, we introduced our financial guidance for 2025 with the assumption that the final LCD will be effective on 04/13/2025. Given this implementation date delay, we expect the environment will be very challenging throughout the first half of twenty twenty five followed by a significant improvement in our business trends beginning in the third quarter. For modeling purposes, we expect the first quarter revenue in the range of $85,000,000 to $95,000,000 and our profitability guidance for 2025 assumes gross margins in the range of 76% to 78%, GAAP operating expenses will be down 2% to flat year over year and excluding non cash intangible amortization of approximately 3,300,000.0 and a non recurring FDA payment related to our renew BLA filing of 4,600,000.0 Our total non GAAP operating expenses will increase approximately 3% to 6% year over year.

Note the expected increase in non GAAP operating expenses this year is primarily related to incremental investments in clinical studies and regulatory related spending in preparation for our Renew BLA efforts as well as strategic investments to support key commercial and organizational efficiency initiatives. Finally, our full year profitability guidance range also assumes total interest and other income of approximately 4,000,000 compared to expense of $1,500,000 last year, A GAAP tax rate and non GAAP tax rate of 26 Non cash depreciation of approximately $14,800,000 non cash stock compensation expense of approximately $12,000,000 capital expenditures of approximately 45,000,000 and a weighted average diluted share of approximately $134,000,000 With that, I'll turn the call over to the operator to open your call to your questions.

Thank you. We also ask that you please wait for your name And our first question will come from the line of Brooks O'Neil of Lake Street Capital Markets. Your line is open.

Thank you very much. Good afternoon, you guys.

I guess, I'd like to start by just asking if you mentioned you expect the first half to be very competitive. Could you just give us a feel for what you're seeing in the market place right now from competitors And maybe importantly also sort of the typical behavior you're seeing from doctors as it relates to loading up inventory of your products or competitors' product etcetera.

Yes, sure, Brooks. This is Dave. Thanks for the question. So we're not really seeing a major change in the competitive environment. It's really more customer buying behavior. As you recall, we had anticipated that the LCD would be implemented on the January 1 and so we expected some disruption in the fourth quarter. When that didn't happen and got pushed to February and now actually pushed out to mid April, we're seeing some kind of changing in buying behaviors with our customers. When any kind of time that there's a reimbursement dynamic change then customers pause oftentimes test the reimbursement, need to get comfortable with it. And what we're seeing right now is exactly that. And as far as what you said about stocking and such, obviously some of our technology as you know that are on the covered list are living technologies. So with that short shelf life, we don't have that option with customers.

Interesting. And then I'm curious, you talked or Gary talked a little bit about process of moving forward with renew And I'm just curious if you could update us on what you're currently thinking the timeline would look like after submission of your application? And how quick be able to put the market the product on the market.

Sure. So we're expecting to file the BLA submission at the end of twenty twenty five. We would expect to hear from the FDA probably in Q4 of twenty twenty six with expectation of getting a approval at the end of twenty twenty six perhaps the beginning of twenty twenty seven. That's our current timeline, Brooks.

Okay, great. Thank you very much.

You're welcome.

Thank you. One moment for the next question. And our next question will be coming from the line of Ross Osborne of Cantor Fitzgerald.

Your line is open.

Hey, guys. Congrats on the strong quarter and thanks for taking our question. So maybe starting off on your sales force, would be curious to hear you experienced any heightened levels of attrition or retention has been pretty good through the quarter and how that's trended year to date?

Yes. Actually, we did see some attrition in the quarter, but it wasn't really that significant, Ross. And we've done a nice job of backfilling those heads and seeing some good talent out there. So we feel good about where we are right now. And again, the team executed extraordinarily well in 2024. So we're pleased Yes, glad to hear it. And then in terms of your products that were not on the covered list, any update on how those RCTs are going?

Could you repeat the question? Yes.

Just curious how your progress on your RC are going for the products not on the covered list?

Sure. So our PuraPly study which we started, we expect to have an interim analysis interim analysis in Q4 and we expect to have a publication in Q1 of twenty twenty six for that study with the expectation of having it ready and available for reconsideration by the MAX by Q1 of twenty twenty six when we believe they'll be considering assuming the LCD goes forward reconsideration of products Okay, got it. Thank you for taking our questions.

Sure.

Thank And our next question will be coming from the line of Ryan Zimmerman with Zimmerman of BTIG.

Your line is open.

Thank you. Good afternoon, everyone. Thanks for taking our question. Congrats on the quarter. Maybe to start, Gary, listening to one of your competitors last night, they expect LCDs to go through as written. You've made the statement that it's your prevailing assumption your current operating assumption just want to be clear, I mean you have no reason to believe it would be changed at this I know this is your assumption, but is there anything you can say from your perspective having had those discussions Are you you're operating under the view that nothing is changing as written right now? That's correct. I mean, I think it's clear to CMS and the MAX that the cost are continuing to spiral And though the LCD is not perfect, we think it's a good step and it's a mechanism to gain some of the savings that they're looking to gain. So we think from that perspective, it's likely, more likely than not that it would go forward. I don't think it will be delayed. That's not something that I think could happen. I mean, it's possible it could be rescinded because delaying it again is caused would cause significant confusion in the market.

And I think CMS is hearing how confusing the market is and patients are not being served appropriately with all of the confusion going on. So That's another reason [indiscernible] in April. It's certainly another reason not to delay it But if for some reason they weren't happy with it, it would be rescinded is probably a better answer quite honestly. At this point in time and start again. But I think it will be implemented.

Okay.

Very helpful. And then as we think about it, in the context of the guidance, I appreciate that you're giving a wider range on guidance For the year, given some of the unknowns, are going to play out here in the first half of the year. But Maybe Dave and Gary, take us through kind of your assumption on both the low end and the high end and what I really want to kind of understand is what's convertible in your mind from a product standpoint what's at risk from a product standpoint as you try and move product usage or sales to the products that are on the covered list. Yes, sure. I think the idea there on the first half really is the fact that because it got delayed from February to mid April was the kind of issue there that just extends that confusion and ambiguity in the [indiscernible] February that we would start to see some switching and transition in February. Now that's obviously pushed to the second quarter. So we've got a longer period of this uncertainty. When we think about the back half though, so I think back your question about low end versus high end.

The one question is, is how quickly do you convert those products in the back half of Q2 assuming it goes into place in April 13? That's one component. How successful are we? And then I think as you think about the back half and as we talked about the business trends changing once we get to the third quarter, As Gary mentioned in his prepared remarks, we're three products out of 'eighteen. So we see a major, major shift in the competitive dynamics in the back half and see a lot of opportunity for share gains amongst ourselves and other traditional players in the market. And us as a market leader we think we'll take a proportionate share of that. So we see the back half being stronger than the first.

Okay.

In addition, Ryan, to converting our own products obviously, there's significant market share available as Dave mentioned. I This a very large component of the market particularly just DFU and VLU is available. What we're also finding out some customers are only using products that are on that approved list even for non DFU and VLU to avoid any potential confusion of using a product inappropriately and not getting reimbursed. So So we feel that the DFU VLU open market is substantial, but there's also non DFU and VLU that we're seeing now with covered products.

And but just maybe the follow-up on the I think one of the big components of the Advanced Wound Care business is PuraPly, right? And as of today, it's not on the list. And But just to remind everyone, not necessarily all purify usage is strictly relegated to DFU and VLU. I guess what I'm trying to understand is [indiscernible] [indiscernible] entire business line isn't going away. Come April 13, and some of that is preserved outside of potentially what's included in the LCD.

That's completely accurate. Just as a benchmark, about 55% of the market is DFU, VLU, the rest of it is non DFU, VLU.

So as a guide, that's generally what we've seen in the space. I think our [indiscernible] relationship to non DFU is a little higher. It's used a lot in dermatology and other wounds. So So PuraPly has a better ratio than that. For us. So you're right, Brian.

There's a lot of revenue still available Very clear.

Including the surgical side.

Including the surgical side. Very helpful, Gary. Yes.

Thank you. And at this time, I'm not showing any more questions in the queue. And at this time, we thank you for participating in today's conference call. You may all disconnect. Thank you very much. Thank you.