Organogenesis at Cantor Global Healthcare Conference: Strategic Shifts Ahead

On Wednesday, 03 September 2025, Organogenesis Holdings Inc (NASDAQ:ORGO) presented at the Cantor Global Healthcare Conference 2025, outlining a strategic vision marked by optimism and challenges. The company emphasized the anticipated benefits of the upcoming Physician Fee Schedule (PFS) changes, while acknowledging a tough first half of the year. With new product launches and operational adjustments, Organogenesis aims to drive growth and stability in the healthcare market.

Key Takeaways

• Organogenesis views the upcoming PFS changes as a "watershed moment" for market stability.
• The company expects a stronger second half of 2024, driven by new products and reduced disruptions.
• Growth in the surgical and sports medicine segment reached 16% in Q2 2024.
• A $70 million cash reserve supports ongoing developments and future plans.
• The Renew product, targeting knee pain, is on track for potential commercialization by 2027.

Financial Results

• First Half 2024: The company faced challenges but stayed within guided ranges.
• Second Half 2024: Anticipated to be stronger due to fewer disruptions and new product launches.
• Surgical and Sports Medicine Growth: Increased by 16% in Q2 2024 and 13% for the first half of 2024.
• Cash Position: Organogenesis holds $70 million in cash.
• Profitability: Expected in the latter half of the year.

Operational Updates

• Physician Fee Schedule (PFS): Expected to stabilize the market and encourage competition based on efficacy.
• Product Portfolio: Focus on PMA products like Dermagraft and Transite.
• New Product Launches: Introduction of two dehydrated products in Q2 2024.
• Commercial Organization: A hybrid rep model is in place to serve doctors in wound centers and ORs.
• Renew Product: Top-line data from the second phase three trial is expected by the end of the month, with a BLA application filing by year-end and potential commercialization by 2027.
• Facility Expansion: Dermagraft relaunch includes facility expansion in Smithfield, Rhode Island.
• RCT Progress: Publication expected by November 1.

Future Outlook

• 2026: The PFS is anticipated to have a significant positive impact.
• Renew Commercialization: If approved, commercialization is expected to begin in 2027, focusing on the hyaluronic acid space for knee pain treatment.
• Sales Force Expansion: Considering building or acquiring a sales channel for Renew, potentially involving 150-200 sales reps.

Q&A Highlights

• Physician Fee Schedule Impact: Expected to stabilize the market and eliminate the ASP plus six model, fostering competition based on efficacy and brand support.
• Surgical and Sports Medicine Growth: Driven by the PuraPly brand and Cygnus Matrix launch.
• Renew Product Launch: Aims to position further along the treatment algorithm for better pricing.
• RCT Progress: PuraPly may be available on the LCD by January 1.

Readers are encouraged to refer to the full transcript for a detailed understanding of Organogenesis’s strategic initiatives and financial outlook.

Full transcript - Cantor Global Healthcare Conference 2025:

Ross Osborne, Med Tech and Diagnostics Analyst, Cantor: Great. We’re going to get started. My name is Ross Osborne, the med tech and diagnostics analyst at Cantor and today we have Organogenesis Holdings. With us we have Gary Gilhini and Dave Francisco. With that, Gary, want to give us a brief background on yourself?

Gary Gilhini, Chairman, CEO and President, Organogenesis: Sure. I’m the chairman, CEO and president of Organogenesis. I’ve been with the company now for about twenty five years. Organogenesis has been around for about forty years. It’s one of the oldest biotech companies in the space.

And our company was formed really back in 1985 based on a spin off out of MIT, Doctor. Eugene Bell’s lab, and did research all the way to 1998 when we launched our first product, Dapolograph, which today is still the only product with two FDA approved indications. And the company has continued to innovate over the years and we’ve gone from a kind of below the knee one product company to a head to toe wound care surgical organization. Been So quite a transition over forty years.

Ross Osborne, Med Tech and Diagnostics Analyst, Cantor: Absolutely. Before we dive in, Dave, would you mind providing a brief background on yourself?

Dave Francisco, Organogenesis: Yeah, sure. I’ve been with Organogenesis for just over four years now. Before that I spent twenty years at PerkinElmer, a life science diagnostics and tools company.

Ross Osborne, Med Tech and Diagnostics Analyst, Cantor: Great, thank you. So jumping right in to everyone’s question around the physician fee schedule. Any updated thoughts here since we saw the initial proposal? How are you guys preparing for this assuming it goes through January 1?

Gary Gilhini, Chairman, CEO and President, Organogenesis: So clearly a big change in the industry is really a watershed moment. Probably the biggest change in our space in over a decade. So we certainly support a lot of the points. We’ve lobbied for a lot of the components that are actually reflected in that proposed rule, which is one is to balance and have consistent reimbursement across sites of care. So all of the ASP sites of care, the doctor office, long term care centers home, and the outpatient setting now have consistent reimbursement.

So it allows the patient and the doctor to treat where they best can get product and where the facility works best for that patient. So that’s a huge change. The per square centimeter reimbursement in both sites of care, which means they’re unbundling in the HOPD setting, is an enormous change, a real positive change in my opinion. And the tiers that CMS identified, based on FDA classifications, they clearly identified PMA products as being clinically differentiated and recognizing that as well as 510s and three sixty one’s as three separate tiers. So we think that’s a real positive step forward that just gives more access to PMA products with proven FDA indications that all patients will now have access to, where they really did not have access to that in certain sites of care based on the reimbursement model.

So an enormous change, we think, the better. Better for patients, better for the market. Will bring stability to the market, eliminate the ASP plus six model, which has brought a lot of challenges to the space. Good news is market has expanded since from ’twenty one to ’twenty four. The market’s doubled in volume, which is good.

That means patients who really do need advanced care are getting it now, like in long term care centers. Unfortunately, the costs have gone up by a multiple of 10, while the volume has gone up a multiple of two. So all that disruption now should leave the market. There really is no financial incentive to use one product over another. It will be based on clinical efficacy, service, and the overall brand support, which is where we live.

That’s the world we live in, so we feel very comfortable that a stable market is ahead of us.

Ross Osborne, Med Tech and Diagnostics Analyst, Cantor: Great. And then maybe to level set the room, could you walk through your current product portfolio, areas of strength, maybe areas where you would like to grow or provide incremental data?

Gary Gilhini, Chairman, CEO and President, Organogenesis: Well, certainly, if the physician fee schedule holds, our PMA products become extremely valuable, both to the patient and to the company. The relaunch of Dermograph, which we’ve announced with our facility expansion in Spithfield, Rhode Island is a PMA product. That’s certainly very positive for us. Our burn portfolio, which includes Transite, which is a PMA approved product, will also be manufactured at our new site in Smithfield. So that’s exciting.

We certainly will continue to build our surgical bag. And as we move down the path with our renew product, if approved, we’ll certainly be building out that channel as well. Great.

Ross Osborne, Med Tech and Diagnostics Analyst, Cantor: And then I guess ahead of January 1, what does the second half of this year look like? Do you think physician behavior changes ahead of the PFS going through as it goes through as is? Or is the second half going to be reflective of the first half in terms of product mix?

Gary Gilhini, Chairman, CEO and President, Organogenesis: I think defer to Obviously, Dave on

Dave Francisco, Organogenesis: the first half was pretty challenging for us, and we knew it, right? So I think we guided in a certain way. We executed against plan. We came in within those ranges in the first half. We always anticipated that the second half would be stronger.

And there are a couple of things there, less disruption, customer disruption related to the LCD moving from go live dates. And then also, we’d launched some new products in the second quarter. And those really gained momentum at the back half of the second quarter. That’s continuing into the third quarter, and we expect to see that through the back half. The only thing we do anticipate is a little bit more pricing pressure as it gets to the end of Q4 because there’ll be inventory on the shelves of some of these companies that will be trying to move that forward before the oneonetwenty six but we’ve incorporated that all into our guidance.

Great. And then you mentioned new product launches. Could we run run through biometrics?

Ross Osborne, Med Tech and Diagnostics Analyst, Cantor: How that fits in your portfolio? I believe you launched in June, so early learnings there.

Dave Francisco, Organogenesis: Yeah, that’s one of them. We launched two actually and both of them are gaining traction. So again, one of the reasons why we think the difference between the first half and the second half will be pretty strong.

Ross Osborne, Med Tech and Diagnostics Analyst, Cantor: Great. And then how does that fit into your broader product portfolio, biometrics? It’s a

Dave Francisco, Organogenesis: dehydrated product, so it’s one of the options that we’ve got in the portfolio. Those are the two that we introduced in the back half, which are both dehydrated products. They have different attributes, but they’ve got a place in this marketplace. So we’re excited about the traction we’re getting so far.

Ross Osborne, Med Tech and Diagnostics Analyst, Cantor: Great. And then maybe switching surgical and sports medicine side of the business. What’s driving growth there? It seems like an exciting opportunity for you guys.

Dave Francisco, Organogenesis: Yes, really is. I mean, grew 16% in the second quarter and 13% for the half. So we are excited about what we’re seeing there. There’s really kind of three things going on. One is we continue to see nice uptick in our PuraPly brand between the antimicrobial, the SX product, which we built specifically for the OR and then the MZ which is a particular product.

So those are doing well. We also launched Cygnus Matrix so it’s another opportunity to have a dehydrated placental based product in the portfolio. And we also have launched an initiative within the commercial organization to have hybrid reps So they’re going both into the OR and Advanced Wound Care Centers. So that’s added some value there too.

Ross Osborne, Med Tech and Diagnostics Analyst, Cantor: And then how does a hybrid rep model play out over time? I guess what’s the runway there versus completely having to bifurcate?

Dave Francisco, Organogenesis: The benefit is you’re just following the doctor. So you’ve got the relationship with the doctor. You can either go to the wound center or you can go to the OR. And so we’ve seen some good traction from that.

Ross Osborne, Med Tech and Diagnostics Analyst, Cantor: Perfect. And then maybe switching gears to renew. What’s the latest update there?

Gary Gilhini, Chairman, CEO and President, Organogenesis: So we finished the second phase three trial and we expect to have the top line data by the end of this month. And if it’s successful, we had a successful first phase three trial, as you know. If it’s successful, we expect to file the BLA application by the end of this year, and have approval by the ’6, one year. And we would expect to commercialize the product in the ’7 after we get coding and get on formularies, particularly with the commercial payers. We would expect to see traction in the ’27, if it’s approved.

Ross Osborne, Med Tech and Diagnostics Analyst, Cantor: So assuming approval, what does that commercial launch look like? Will you guys need to generate incremental data? What does the sales force needed to commercialize that product?

Gary Gilhini, Chairman, CEO and President, Organogenesis: Well, we certainly think we want to commercialize the product ourselves. So we’ll have a direct sales force. Now how we get ourselves into that channel, it could be that we build it, it could be that we acquire it. So we’re looking at all options. Certainly acquiring a channel, maybe the fastest path to revenue and potentially add to the pain bag as well.

So we think that that’s certainly the optimal way to go. But if that’s not an option, then we’ll probably build our own sales force, which we think would be about a 150 to 200 sales reps starting Got

Ross Osborne, Med Tech and Diagnostics Analyst, Cantor: it. So what does that marketplace look like in terms of competitive offerings? Who do you think you can displace Or are you guys growing the market?

Gary Gilhini, Chairman, CEO and President, Organogenesis: It’s an interesting market, the pain space. So today, the algorithm is NSAIDs, physical therapy steroids, then hyaluronic acid is kind of the last resort before a total knee replacement. Unfortunately, the gap in time with a lot of patients who are receiving hyaluronic acid and when they can get a total knee replacement is a long time. So it’s a challenging time for them. So we think if approved that we would be attacking that hyaluronic acid space And we’re happy to to be even after the hyaluronic acid assets if necessary.

If that gives us a better pricing, which it could, The further along you are in the algorithm and there’s no other options, it gives you a bit of an opportunity with good data to get some some better pricing. But the hyaluronic acid and and after they’ve exhausted hyaluronic acid is where our space is, where our sweet spot is. Perfect.

Ross Osborne, Med Tech and Diagnostics Analyst, Cantor: And then I guess maybe touch base on the balance sheet. How are guys feeling about it?

Dave Francisco, Organogenesis: Yeah. Really good. So obviously, we did utilize some cash in the first half, but with $70 some odd million of cash on the balance sheet and our forward looking ability to generate profit in the back half, we feel quite comfortable with it.

Ross Osborne, Med Tech and Diagnostics Analyst, Cantor: And then looking at 2026, what excites you the most?

Gary Gilhini, Chairman, CEO and President, Organogenesis: The PFS schedule excites us the most, quite honestly. A stable environment, competing on efficacy, competing on brand is a place that we like to live. Our portfolio is developed differently. Dehydrated amnions really dominate the market, but our portfolio is built on these stages of healing from the inflammatory stage all the way to the remodeling stage. We have products in each stage and that’s how our algorithms and our reps are trained.

And we have dehydrated as well as living technology depending upon the comorbidities of the patient, need. So, you know, where we have the broadest portfolio, but it’s not just, similar products in a broad portfolio, it’s different technologies. So we cross PMA’s, 510s, three sixty one’s and we think that’s the right way to treat the patient. We think that’s the right way the market should be looking at companies and portfolios that can solve all of the stages of healing. So not to get into the stages of healing too deeply, but the first stage is the inflammatory stage.

Most wounds stall in that stage, and you can’t move on to healing until you get out of it. So our PuraPly antimicrobial product prevents the reformation of biofilm and bioburden in the wound, so it can move on to healing. And many times they will heal if they have other comorbidities in the patient where they need additional products or all the way ultimately to a living technology to get that wound to heal, we

Ross Osborne, Med Tech and Diagnostics Analyst, Cantor: have it. Great. And then any questions from the audience? If not, and lastly for me, any update on your RCT progress?

Dave Francisco, Organogenesis: Yeah, it’s moving along. So we expect to have a publication by the November 1. And so that’s in line with the expectations. And so we hope to have PuraPly available on the LCD in the January 1. Yes.

Great. Looking forward to

Ross Osborne, Med Tech and Diagnostics Analyst, Cantor: that. Well, for being here.

Dave Francisco, Organogenesis: Appreciate Appreciate the time invitation. Appreciate it. Thank you so much. Thank you.

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