NEXGEL, Inc. (NXGL) Earnings Call Transcript
September 24, 2026
Earnings Call Speaker Segments
Hello, and welcome, everyone joining today's NEXGEL Investor Update Conference Call. [Operator Instructions] Please note, this call is being recorded. We are standing by, should you need any assistance. It is now my pleasure to turn the meeting over to Steven Glassman, Chairman of the Board of Directors. Please go ahead.
Thank you. Good afternoon, everyone. Welcome to the update call. I just wanted to reiterate, we appreciate everyone's interest as well as their patience over the past 6 weeks, as noted in the press release from the middle of August, just taking a step back and looking at the entire company and the different lines of businesses holistically and determining what is best way to move forward with shareholder value. So with that said, I'm going to go ahead and turn the call over to Brian Kieser, the Interim Chief Executive Officer and have Brian start out walking you through the update.
Thank you, Steve. Good afternoon, everyone. My name is Brian Kieser. I have the pleasure of holding the title of Interim Chief Executive Officer of NEXGEL Inc. I appreciate everybody's patience again, to reiterate what Steve said, over the last 6 weeks as we've done a strategic review of all of the business and our goal to determine the best path forward for NEXGEL its shareholders. What we will discuss today will be really a proposed platform reorganization that our Strategic Review Committee, along with our employees, have worked very, very hard on over the last 6 weeks. And before I begin, I do want to take a second to mention how important the employees have been over these last few months since this transaction with Celularity took place. I can tell you that we have a very hard-working, very dedicated team. And they have gone above and beyond to try and do everything they can to work with us and help us develop what we think could be a very successful plan for NEXGEL going forward. So a public thank you to all of our team members at NEXGEL. So where were we versus where we are now versus where we go tomorrow. Traditionally, NEXGEL was a high-quality hydrogel manufacturer and had a medical device pipeline. However, it looks to me and appears to us that NEXGEL drifted into non-medical, non-health care-related lines and focused more on over-the-counter consumer products. And we believe that those product lines have created a misalignment and a disconnect between the operational needs of the hydrogel business, legacy business and the needs of the -- and requirements of the over-the-counter business. And because of that, we feel like in order for NEXGEL to focus on a growth path, that we need to transform NEXGEL from an over-the-counter products line into a medical device line, a biomedical innovation line and a company that can scale in those areas. The transformation that we're talking about started with the acquisition of a diverse portfolio of licenses from Celularity. And those -- the portfolio of products really centered around regenerative biomaterials and focused on skin grafts, skin substitutes and products that can be used both in wound care and in surgical settings. Many of you may know that I came into the NEXGEL orbit as an initial investor in that transaction through Fountainhead LifeSciences and one of our subsidiaries, Sequence LifeScience. We committed $6.5 million of our investment towards innovation, training, manufacturing and supporting NEXGEL. And our goal was to become a strategic partner with NEXGEL, supporting the manufacturer and the economics of the products that were acquired in the Celularity transaction. We have done a great job. I think NEXGEL has done a great job as well as Sequence in working through a lot of those strategic partnership opportunities, and I'll be talking about that a little bit later. But that's only part of the really of the goal that we're trying to get to. And we see a vision for tomorrow for NEXGEL that creates a market-facing gateway for surgeon engagement that creates a closed-loop experience for surgeons to innovate and create medical devices and biomedical innovation that will help patients. We want to create a single point of care and continuum of care portfolio, and we want to create diversified lines among clinical reimbursement verticals and reimbursement channels. Our goal is to take NEXGEL fully into medical technology, medical device, biomedical innovation and focus on improved patient outcomes and procedural excellence within the clinical setting. Why we are here, I guess, is the next opportunity -- the next thing we need to talk about. Again, the most recent transaction is the acquisition of the Celularity assets by NEXGEL, the licenses of several of the biomaterials, placental skin grafts, et cetera. Our original acquisition thesis did not materialize as we expected it to. The original expectations were for a significant revenue growth, immediate profitability, a successful BioNX commercialization, existing reimbursement and clinical use pathways and expansion through additional products. What actually occurred, though, is that revenue and margin expectations were not achieved, customer products consumed more capital than anticipated -- excuse me, consumer products consumed more capital than anticipated, manufacturing and commercialization challenges disrupted execution, the initial BioNX commercial structure added cost, and the existing organizational structure separated manufacturing profits from commercialization economics. What did work in our transaction -- post transaction with Celularity? Interfyl, one of the core products acquired, remains a stable revenue generator. Arthrex, one of the -- our most stable customers, continues to bear fruit and be a strong and strategic relationship with NEXGEL, and we believe it presents multiple expansion opportunities. Our manufacturing transfer of technology to Sequence, which we believe will lower costs and improve margins, is occurring ahead of schedule. We recently launched an ocular business, and we believe that, that opportunity is positioned for growth. We have reevaluated the hydrogel component of NEXGEL, and we believe that there are additional revenue opportunities that have been unrealized to date. And we also believe there are opportunities to decrease costs and improve margins across the hydrogel line. We've also scaled the BioNX leadership to an appropriate level and have found and secured the leadership talent needed to grow the Celularity products acquired by NEXGEL as we move forward. What didn't work? The consumer products just underperformed. Those products have been losing revenue, have been declining in revenue over the last several years. Margins continued to erode, and most of the consumer products are operating at a loss. Working capital was consumed much faster than expected, partly due to an increased BioNX personnel ledger. As we first made the transition, we again scaled that back and have properly staffed the BioNX commercialization team for these products. The commercialization assumptions, the operating profits and the sales opportunities of these products were misunderstood, and that -- we discovered that early into the transaction. And the initial cost structure and actually, current cost structure of the manufacturing and cost of these products are just not sustainable. And so cost reductions are necessary, have been necessary and have been implemented. But the cost reductions alone will not unlock the value of the assets that we have. In short, the current structure is not sustainable. Our primary constraints as of today are liquidity. Additional capital is required. Debt, the current operating business cannot support the $15 million of debt burden. Profitability, the stand-alone economics of NEXGEL remain insufficient to support the current structure. And fragmentation. Management, manufacturing, regulatory, quality and commercialization capabilities are distributed across separate entities. The strategic review identified a path to consolidate the regenerative medicine platform. The Fountainhead operating team and the Sequence LifeScience and NVISION Biomedical Technology assets, we believe can be integral to a proposed reorganization. The status quo right now is limited liquidity, large debt burden, fragmented operations and constrained access to growth capital. We believe that a reorganization could provide new capital, a recapitalized balance sheet, contributing operating assets from Fountainhead, consolidated management and infrastructure and a platform positioned for future financing. So I'd like now to provide you what our vision is for NEXGEL and what we are trying to build for the future. We believe that we could create, in a reorganization, combining all of the assets, an integrated life sciences ecosystem. We could create a surgeon-centric platform that shapes procedural excellence across clinical indications. It would connect innovation, training, manufacturing and commercialization into 1 coordinated system, 1 entity. It would place the surgeon, the procedure and the patient rather than the product at the center of the platform, engagement and the ability to influence procedural excellence to find the experience. The platform is designed to advance procedural excellence, improve patient outcomes, advance standard of care and enhance quality of life. We believe that we can create a scalable, high-touch experience where we can scale infrastructure while preserving personalized, trust-based surgeon relationships. We believe that we can create surgeon-led product development where healthcare providers across all disciplines use real-world clinical insight to guide product development, validation and education. We believe we can reduce fragmentation and friction. We'll integrate capabilities, accelerate learning and training and reduce execution risk. We believe we can address many of the industry challenges and center an experience around patient outcomes and quality of life. So what would this look like? When simplified, Fountainhead LifeSciences is a platform that provides innovation, manufacturing and engagement through a series of entities. The engagement would come from the current NEXGEL commercialization team, the innovation and manufacturing. The engine, if you would, would come from NVISION Biomedical Technologies, Sequence LifeScience and LockHill Advanced Manufacturing Technologies. All members and subsidiaries of the Fountainhead LifeSciences platform and the experience tying it all together, where innovation, manufacturing and engagement come together to improve patient outcomes, elevate the standard of care and elevate quality of life would be done at the CadaverLab housed here with Fountainhead LifeSciences. And so what is Fountainhead LifeSciences? And what are the subsidiaries of Fountainhead? What assets do they have that will help support this vision? NVISION Biomedical Technologies is an orthopedic medical device company that manufactures -- develops and manufactures spinal implants, lower extremity foot and ankle implants and sports medicine implants. It houses a complete engineering and design team, has its own internal prototyping capabilities in-house, intellectual property patent council, an entire quality and regulatory management team and a robust product commercialization and sales team. NVISION has cleared over 35 products with the FDA and holds over 20 patents for medical devices in the orthopedic space. Sequence LifeScience, which many of you may know led the investment, is also a Fountainhead subsidiary. Sequence has 17 ISO Class 5 cleanrooms, it has ISO Class 7 lyophilization rooms and 3 ISO Class 7 packaging rooms. Sequence also has a full R&D wet lab doing research on human tissue, placental tissue stem cells, many advanced future cellular therapies. It has a staff of PhDs and scientists. It has its own quality and regulatory department. It has its own manufacturing and operational staff. And in addition to producing products that it sells and commercializes, it has a robust contract manufacturing and packaging business. LockHill Advanced Manufacturing Technologies is also another asset that Fountainhead can bring to bear. LockHill currently runs 10 polymer and resin printers, has post-processing, milling and machining capabilities, has FDA regulatory and quality teams and also is able to do contract manufacturing for third parties. LockHill and NVISION are the leaders in lower extremity nonmetal solutions for the foot and ankle and have expanded their products into sports medicine and other extremities. And the CadaverLab is a 2,500 square foot 12-station surgical suite and [ Bioskill ] suite. It has a state-of-the-art classroom lecture hall that could accommodate 75 or more participates. It has another 750 square foot overflow community classroom. The CadaverLab trains -- currently has contracts and trains EMTs. Fire departments were using CadaverLab training for pre-emergency room trauma. It is a training and [ Bioskill ] suite for many of the large orthopedic and other medical device companies around the country that come and train surgeons when they're in the San Antonio and Hill Country area of Texas. And it is a -- the centerpiece of what Fountainhead does and how Fountainhead operates as a fully vertically integrated system. So what are we proposing? We're proposing to reorganize, contribute the core Fountainhead operating assets to NEXGEL as part of this reorganization. We're proposing to raise $5 million in new capital. With that, we will recapitalize and simplify NEXGEL's balance sheet. Our goal is to align the ownership, management, manufacturing and commercialization, and we want to operate through a single public company platform. But what does that look like? Today, multiple entities are trying to share economics in order to operate. We have duplicated infrastructure between the NEXGEL teams and the Fountainhead teams. The economics, again, are divided between the companies. And each company -- each entity has its own capital requirements. Our vision for the future is 1 platform, 1 management team, 1 capital strategy and 1 public ownership vehicle. What Fountainhead would contribute to this is more than $10 million of 2026 revenue. We would contribute our tissue processing and biologic manufacturing operations, existing supplier donor recovery and customer relationships, the capabilities to manufacture the products recently acquired by Celularity, a complete established quality and regulatory infrastructure, a product development and innovation platform that serves both medical device and tissue and biologics and pending clinical trials for Sequence products. The NVISION medical device business would also be contributed, includes 20-plus patents on medical devices and processes. And a complete engineering and design team, a complete specialized quality and regulatory team. It's about $10 million to $12 million of inventory between Sequence and NVISION, a 42,000 square foot production facility and associated real estate, cleanrooms, manufacturing equipment, prototyping equipment and additional equipment valued by management in total, of between $17 million and $20 million. What other things are we hoping to contribute? Strategic assets and economic contribution, an experienced management team, integration with the CadaverLab surgeon-led engagement ecosystem, accounting, finance, human resources, marketing and investor relations support. These are operating assets and capabilities, these are not passive investments. All descriptions and the values we believe should remain preliminary and subject to an independent review and evaluation. Why consolidation changes the economics. The platform economics, we believe, are stronger than the stand-alone economics. Under the current structure, again, the manufacturing economics are realized outside of NEXGEL. The commercialization costs and the risk concentrated are concentrated inside NEXGEL. We have duplicated expenses, separate funding requirements, and there's limited ability to invest in growth. If we combine, the manufacturing and commercialization economics are consolidated. We share an operating infrastructure. We diversify revenue across hydrogel biologics, medical devices and contract manufacturing. We have a greater ability to invest in products and innovation and commercialization and a much improved pathway to profitability. The value is created by consolidating assets, earnings, management and capital. I'd like to speak briefly, but intently on an illustrative combined company financial profile. This is an unaudited estimate, and it would be subject to completion of the audit and preparation of SEC compliant pro forma financial information. The objective we're trying here -- to achieve here with this reorganization is to survive is to emerge with a business model that can actually generate attractive gross margins and operating profits. Standing alone today, NEXGEL's revenue for the next 2 years are forecasted at $11 million in fiscal year 1, with a gross profit of roughly $2.7 million, a gross margin of 24% and an operating profit -- or operating loss, excuse me, of $1.5 million. In fiscal year 2, a modest $2 million growth of $13 million, gross profit of $3.5 million, equating to a 27% gross margin, with a $600,000 operating loss. If we reorganized, in the first 12 months following reorganization, revenue at current levels, assuming no growth and no other additional outside opportunities, would be just shy of $21 million with a gross profit of $15 million and a gross margin of -- excuse me, 73%. The overall 12-month loss would be $1 million, but that loss would be over really the first 5 or 6 months as we're recovering and cash flow positive over the second half of that first 12-month period. In the second 12-month period, forecasted revenues, $31 million; gross profit, $23 million; gross margin, 74.6% and an operating profit of $4.4 million. As I mentioned earlier, part of the reorganization is new capital requirements. We believe we need approximately $5 million of new capital, 40% of this to support operations and liquidity, 22% to restore commercial growth, 28% to integrate the platform and launch growth initiatives and 10% to pay the transaction costs. No proceeds are intended to fund consumer products, noncore assets or the legacy initiatives that do not fit into our proposed platform strategy. The recapitalization objective is to reduce or eliminate the existing debt burden through conversion or restructuring, provide an operating runway, complete the platform integration, restore commercial execution and position the company for future financing. What this means for existing common shareholders? In short, a smaller percentage of a potentially stronger and better capitalized company. Currently, shareholders maintain approximately 21% ownership after a full conversion of the $14.9 million in convertible notes, excluding any warrant exercise. Alongside that, the company's liquidity is constrained, debt burdened. It has separated manufacturing and commercial economics, and it has limited, if any, ability to finance growth. Under our proposed platform, existing comp shareholders retain approximately 5% ownership in the following proposed recapitalization, which is a new capital raise, management equity and Fountainhead contribution. Debt is recapitalized, operating assets and management has contributed, manufacturing and commercialization economics are consolidated, new growth capital is introduced and revenue base is diversified. This proposed transaction will materially dilute existing common shareholders. However, we believe the investment thesis is that a smaller ownership percentage and a better capitalized, more complete operating platform can provide greater long-term value than a larger ownership percentage and the currently liquidity constrained and fragmented structure. What would be our process, our protections and our next steps? We would immediately move for an independent governance process. This proposed transaction is a related party transaction. We would ask for review negotiation and approval by the independent special committee. We would ask for independent legal counsel, an independent financial adviser, an independent valuation, an independent fairness opinion, completion of audits of the contributed businesses defendant agreements, satisfaction of the applicable NASDAQ and SEC requirements, and stockholder approval, if required. In the near-term processes, we need to evaluate stakeholder support, secure interim liquidity, begin audits and independent valuations, negotiate definitive transaction documents and pursue necessary finance and required approvals. I want to make sure everybody understands on this call that no transaction has been completed. This is simply a proposal that we want to make aware to all of the shareholders. Management believes the proposed reorganization offers a more attractive past than preserving the current structure. But the transaction remains subject to an independent review, evaluation, negotiation, financing and required approval. I want to thank you all for taking time to walk through that with me and for your attention as I walked through this deck. It is available online. And we have filed the appropriate 8-K with this, and it is available for you. I want to make myself, I want to make Ian Blackman, our Chief Financial Officer; Kevin Harris, the Chairman of our Strategic Review Committee; and Steve Glassman, our Chairman of our Board, available as we open a question-and-answer portion of our call. And I, again, thank you for your time.
[Operator Instructions] Our first question comes from Naz Rahman with Maxim Group.
I have a few. So the first one I want to start on is on time line. Just sort of a 2-part question. So at the end of 2Q, those [ biases ] assets that was acquired earlier this year, they weren't really fully integrated in terms of like the tech transfer in terms of like setting up and training the sales force and in terms of securing contracts with potential institutions and payers. And now you have this proposed transaction. So my question is, one, how long do you think it's going to take, given it has an area to completely integrate the BioNX asset? And does that affect the time line, the [ rose ] integration? Does that have to occur first? And two, how long do you think it would take to do the proposed integration?
Thank you for the question. So as of today, I can share with you that our Sequence processing, tissue processing team spent 6 weeks at the Celularity facility, learning how to process, specifically Interfyl, which is a specialized product and something that is outside of what our team at Sequence has ever made before. As a matter of fact, Celularity is the only one in the country making it. We completed the tech transfer on September 12. Our team returned here. We actually purchased equipment from Celularity needed to make the product, and our team is going through the installation and the validation of the equipment that is needed to produce Interfyl. We believe that -- and Celularity has been very supportive of this tech transfer, and I do want to take the opportunity to thank them on that. And we believe that we should be ready to produce Interfyl internally in San Antonio within the next 2 to 3 weeks. We're finalizing packaging right now, final packaging. And we believe that we should be able to turn on manufacturing here. That's going to continue regardless of the time line of the transaction as that is part of what we have to do in order to keep NEXGEL moving forward. NEXGEL, under the current arrangement, just won't be able to with the economics that are currently there. Without us helping manufacture, we're not going to be able to hit the numbers we're hoping to hit. As it relates to the other tech transfer pieces, those were completed, and we're starting production down here in San Antonio. So from an integration of the manufacturing of the products acquired in the Celularity transaction, Interfyl would be the last of our products to integrate. Again -- and I would tell you that we're -- again, it's been a lot of work. We -- as I said, 3 of our team members spent 6 weeks up there. But I would also say that from a sales standpoint, from a sales integration, we have been to Arthrex. We've met with Arthrex, had very, very promising meetings. We feel like there's a back order, there's a significant back order currently with Arthrex. We feel like we can -- we're going to be able to dig in that once we start manufacturing down here in the next 2 to 3 weeks. Does that help answer your question?
Yes. The other part of that question was, how long do you think it would take to complete the proposed integration?
Well...
Between the two companies.
I think the near-term stuff is within weeks. The longer-term integration valuation audits, that could take 3 to 5 months.
Got it. That was helpful. So my next question is on those hypothetical combined financials. Does that combined financial, does that include BioNX running at full operations and at steady state? Or are you still assuming in those financials that there's still a ramp-up in BioNX from fiscal -- for fiscal year 1 and 2?
I'm going to let Kevin Harris, member of the Board and Chairman of the Strategic Review, jump in on those questions.
Yes, that's a great question. So the BioNX assets that are assumed in the illustrative combined forecast are essentially -- we wanted to be conservative because we believe that the assumptions that were undertaken at the beginning of the transaction produced underrealized revenue outcomes and also really have some underappreciated framework around the margins that existed with those revenues as well. So the forecast that we put together assumes, first and foremost, the elimination of participating in all of the consumer product lines and businesses that NEXGEL has historically been in. It assumes the hydrogel business continues to operate under the rolling 12 months of historical revenues that they've had, applying no growth on them in the first year and applying no changes or efficiency gains to the cost of goods that would go into generating the hydrogel revenues. With regards to the purchased assets that BioNX is commercializing and that were purchased from Celularity, we split it out to really the piece that is being supplied to Arthrex, which is obviously one of the core assets that was purchased in the transaction. And what we did was we took the existing order since the close of the transaction in April, plus the orders that have not been fulfilled and sit in a backlog or that are backordered but have been placed by Arthrex, and we annualized those moving forward on a 12-month basis so that we can show essentially what is happening real time since the integration in the purchase of those assets. And we're basically in doing so, we're moving away from the forecast that might have been placed or assumed by previous management under the conditions of what they thought they were buying on the Celularity side. So that generates a little over $6 million from an Arthrex perspective. And then the second piece is all of the other biologics assets. If you call them skin substitutes or patches, it's everything else that would include, in particular, things like BioVance that is being sold by the BioNX piece today. And then the combined businesses takes in addition to what we just talked about with the NEXGEL hydrogel assets and the purchased assets from Celularity and stacks on the revenue streams that exist with the medical device business on NVISION and the similar biologics business that exists today at Sequence. Really, the big piece that comes out of that is, yes, the stand-alone company has about $11 million of revenue and the combined company has almost $21 million of revenue. But I think that if you look at the print version of this presentation and have a chance to kind of digest the numbers, what is really much more meaningful is the fact that the stand-alone business today of NEXGEL has operating losses going forward on pretty much a continuous basis and is achieving that off of gross margins that are in the low 20% -- mid-20% range, which really doesn't provide adequate coverage to run the business. And when you combine these, capturing the manufacturing economics alongside the commercialization economics inside of the same company, what we're really capable of being able to do is shift the gross margins into the mid-70s range. And that is really what the achievement of putting these assets together is, yes, we've been working on cost reductions. Today, we've reduced cost already by a little bit over $1.5 million. We are underway with reductions right now that are going to eliminate another $2.5 million. So collectively, we're reducing and rightsizing the cost structure for the historical NEXGEL business by a reduction of over $4 million. But the restructuring of the business itself is what adds a tremendous amount of value.
Got it. That was very helpful. And then one last question, if I may. So I understand you're shutting down the consumer line. But are you also planning on divesting the consumer lines? Or have you potentially initiated the process of divesting the consumer lines? Like what kind of multiples are you sort of seeing or what kind of sales price that you get for the...
Yes, great question. At this eye and condition of the products, knowing that they're kind of operating in a less than attractive gross margin position and they're losing money to operate them. Some of that capital loss is generated because we're a public company. So if you had a private market buyer, they might not have the same loss structure that we would. But in general, they operate or they sell at about a 3x multiple of sales. Plus if you have substantial inventory, you take that cost on. Typically, the 3x sales also comes with 2 to 3 months' worth of inventory as is assumed. That goes into that transaction. We've gone through the process today of looking not only at what we have in inventory, but the historicals, and we've already engaged an outside broker to give us a valuation. And we've started to take the process to build the listing package, if you will, and the term sheet, the offering memorandum to get that out. So I think I said it was 3x sales, 3x profits. So we don't see these assets bringing significant value given that the profitability is really not that meaningful. There is collectively across the board, somewhere in the neighborhood of $400,000 to $500,000 of inventory between all of the consumer lines of businesses. So that may be where, give or take, the final proceeds come in from lifting this. But we have started the process. We're creating the offering memorandums to list it on a -- with a listing broker that sells these types of businesses on a day-to-day basis.
[Operator Instructions] Our next question comes from [ Andrew Dean ], [ Present Value ].
Very clear presentation. Thank you very much. I'm just interested in your OTC [ agta ] business. Are you proposing that for sale?
I'm sorry, could you repeat that question?
Yes. So I'm just saying, very clear presentation. Thinking about your hydrogel business, are you -- I think from the previous question, are you proposing that is in a sales process finance?
For the hydrogel business? So we believe that there is significant value that can still be extracted from the hydrogel business. And again, as I mentioned at the outset of the call, the team, the employees that we have, our team members have done an unbelievable job. They've been coming forward with opportunities to take cost out of the hydrogel manufacturing process. And so we believe that there is value in the hydrogels. We believe that there's a tremendous value in surgical applications and more hospital and office type applications for the hydrogels. And so our goal is to continue to try and -- our goal is to continue to try and grow the hydrogel business while taking cost out of the system, making them more efficiently. The other thing is the hydrogels, when placed into the surgical settings, in these hospital settings, there are many times on the same call patterns as the NVISION products that are being sold and marketed to hospitals and surgeons as well as in many cases, the tissue products that are being marketed to hospitals and surgeons. So being able to put the hydrogels in the sales bag of our distribution partners that are currently carrying the medical device products as well as the tissue products, it allows us to really put more in the bag to sell. And it gets -- our goal is to get more of the pie when we're marketing these products.
Okay. That seems to make sense. So it's not for sale? Basically, your...
The hydrogels? No, at this point, no, we believe the hydrogels can be a significant asset operating asset for the combined entity.
And the hydrogel today are function as a modestly profit line of business in isolation. So -- it's something that is not punishing us in the near term from a liquidity perspective.
Sure, understandable. Have you considered sort of outreach into other international markets for the hydrogels?
Yes, we have. We've had preliminary discussions outside the U.S.
And on the regulatory standpoint, do you think there's a chance of success now?
I think it's too early to tell. I think there's always an opportunity for success. It's just where you're looking to market the products, what the individual countries, healthcare regulatory environment looks like. And so if we're going to do something like that, we would look at the ones with the most favorable and probably easiest paths to allow us into the country market. But we're still evaluating that. We've had people reach out, but there's nothing substantive to report on. And thus, we haven't built any international sales for hydrogels into our existing forecast.
Interesting, but you already to consider?
I'm sorry?
You receive them? You would be...
Yes. We're considering, for sure.
Our next question is from [ Beth Mihalos ], private investor.
So just wanted to -- for the purposes of clarification, I wanted to ask you the following. The 12 trailing month sales for NEXGEL before this transaction, before the original transaction with Celularity, was $11.27 million. Let's call it, $11 million. And then according to press releases, [ take cases ] and so on, an additional run rate of about $22 million to $24 million was brought over from Celularity. We were told and we read in multiple press releases that the run rate of the business was expected to be combined as is, about $35 million or tripling the size of NEXGEL. And so I'm confused here when I hear this in the press release and I see the presentation on the SEC website. You're saying NEXGEL today as is, is anticipated to do only $11 million in sales. So what happened with the $22 million that came from Celularity?
The $22 million from Celularity, unfortunately, hasn't materialized. And there are, I think, a misunderstanding of the Medicare reimbursement environment for wound care, I think, is a large factor in that. And the estimation of how much surgical business would be brought from Celularity and the sales mix between wound care and surgical I think was misunderstood as well. So those numbers did not materialize. And so it's -- our goal now is to look for new channels. And basically, we're going out working with new distributors. We're working with new customers and looking for new channels for the Celularity products.
So you're saying that NEXGEL raised $15 million to purchase an asset that was producing $22 million in sales at Celularity. And once it came over to NEXGEL, we just changed the name on the door, so to speak, with -- previous management said that there were sales force people coming in, in fact, investing in the deal and so on. So once this asset came over to NEXGEL, sales dropped to 0 basically from $22 million run rate going to 0?
Not to 0, but substantially lowered. And again, that's the Medicare reimbursement. The majority of sales from Celularity that Celularity reported and that were used as an estimate of what was coming over were made in the wound care environment. And at that point in time, the wound care reimbursement rate for Celularity products was north of $1,000 per square centimeter. In January 1, 2026, CMS reduced all skin substitutes. So not just the products that Celularity we're selling, but the products that Sequence sold the products at every other skin substitute and skin graft company sold to $127 per square centimeter. That's a decrease of 90%. And so that went into effect January 1, 2026. And so even at historical volumes, the sales revenue was going to be cut significantly.
Wow, okay. So on a previous conference call, somehow I believe -- I took at least a mental note that the wound care business from the Celularity assets was only about 10% of their overall business. And there were "6 existing lines of commercialized products." And forgive me, I didn't go into each and every 1 of them because this is only 1 of my investments, right? So I assume that wound care was only 10% of the -- what was coming over from Celularity, but it appears that now almost everything was coming from Celularity was wound care? Is that what kind of happened?
That's correct. Yes, that's correct. The majority of Celularity sales were in the wound care space. I think it's important to know that -- note also, yes, Medicare dropped their reimbursement by 90% to $127 per square centimeter. Which, by the way, they have a firm that is going -- that is going to be the same reimbursement in 2027. They announced that in July. But I think there's something else that needs to be made clear and that it needs to be understood in this. In addition to dropping the reimbursement, the $127 per square centimeters, audits of claims increased fivefold. There are audits on almost every claim being made now in the skin substitute wound care arena. And those audits are, many times, resulting in clawbacks from Medicare to the physician. And so the way clawbacks can sometimes work is that the physician gets audited for a prior year's claim, say, something that was done in Q3 or Q4 of last year. And as a result of the audit, they aren't required to repay that claim. And how that is repaid is either the physician, the provider sends a check in. But more often, they recoup it from further Medicare claims. So let's say that the provider is submitting claims in Q3 of 2026. And he gets an audit for Q3 of 2025, and that audit results in a clawback. They will deduct the claim being paid from Q3 2026 for the amount due on the clawback. And we are seeing in effect, healthcare providers not getting any reimbursement. Where they should be reimbursed, and I'm just going to put out a number, $10,000 over -- for several claims, they get a 0 bill. They get a $10,000 bill -- they get a $10,000 claim showing paid with a deduction of $10,000, and they get 0. And the number of those audits that are currently occurring, we are seeing practices go out of business. And physicians and healthcare providers not able to provide these wound care services to patients. And unfortunately, the patients are the ones that are suffering because they're not getting the treatments needed that these products can provide. I hope that adds color to the situation that we're currently dealing with, with wound care products.
That's terrible because once you say that reimbursements are down 90%, I wonder whether anybody's skin ulcer, diabetic or otherwise, would ever be repaired. I mean, how can you have a business where 90% of revenue disappears just like that? Whoever -- I don't see how that model is going to continue, but this remains to be seen, God help us. And just to summarize this, I just wanted to make sure I understand this correct. So basically, what used to be a $22 million -- $24 million business at Celularity run rate, $24 million business last year became almost 0 run rate business because of changes and this and that at NEXGEL. That's what happened. We got nothing. Existing -- the shareholders that were in NEXGEL last year in December got diluted, got a business that on paper was doing $20 million to $24 million and now it's doing next to nothing because of regulatory and other changes. Is that kind of correct?
Yes. It's unfortunate to say that, but I would say that I would agree that the sales numbers that were forecasted were not achievable. And a lot of this is due to the decrease in reimbursement, again, a 90% decrease in reimbursement and the fact that there just aren't the number of providers putting these products on, they can't afford to put the products on. And it's unfortunate that this kind of tsunami of activity happened right around the time that this transaction was being effectuated. And I would say it's happening across the board. I would invite you to research other companies in the space and see how they're doing as well. It's not affecting just NEXGEL, it's affecting everybody in the space. I would say this though, and I'd invite you to do some research. CMS did put out some documentation on -- in July, I want to say it, right around, on or around July 15, which addressed the clinical evidence, the type of clinical evidence that they would look for going forward in the future for these types of products, the types of products that Sequence and NEXGEL now make. And they referred to a consensus statement that was done by a group in November of 2025 as to what level of evidence they really believe can demonstrate efficacy of the product for use and reimbursement in wound care. It's led many to believe that there might be some further guidance coming from CMS that might call for clinical data in the future. I will tell you that we believe that clinical evidence for these products is going to be paramount to reimbursement and that products that don't carry clinical evidence will potentially fail to be reimbursed. The other -- tell you that is kind of a nice silver lining in this, if there is any silver line to find is that the BioVance product that was purchased and acquired -- the license acquired by NEXGEL is one of the few products that has commercial reimbursement in addition to Medicare reimbursement. And so we are seeing an increase in revenues on the commercial reimbursement side for these products, which is a very good sign. We are receiving -- we're not actually having to go out and sell. We're actually receiving calls from people about purchasing the product and using it because it does get commercial insurance reimbursement. So we're doing everything we can to maximize those opportunities. And Dave Hazard, who runs BioNX commercialization side of that for NEXGEL, he and his team are working and pursuing every lead that we get. And we do get leads, I would say, on a biweekly basis from companies looking to carry the product. So we're working to find sales channels, any available sales channels on wound care, but we're also working very, very hard to establish a stronger surgical and clinical network for these products as well.
Now let me ask you a couple of questions on hypothetical here. So hypothetically, after this transaction is the way -- this transaction, the way you envision it, and whole team, company, new NEXGEL, let's call it new NEXGEL, we'll have sales of approximately $21 million annualized. So from the existing $11 million in original NEXGEL before the Celularity transaction, what kind of revenues from those $11 million will be part of this $21 million in the new company? After all sales of assets, shutdowns, whatever you're divesting from right now, what part of this $11 million of original NEXGEL will go into the $21 million of new NEXGEL?
Well, we're taking out some consumer, right? Because in the new [ NVISION ], what we presented, we're taking out consumer. Our goal is to divest the consumer assets.
Right. So is that $5 million, $6 million, $4 million, $3 million? What is being sold? What is being jettisoned?
The consumer products, Silly George, Kenkoderm and any of the other consumer product, any of the other consumer product.
Just stuff like this. But what kind of revenues are we talking about basically selling out, selling to private equity or something out of the $11 million run rate?
I would say probably in the neighborhood probably $3 million to $4 million is what the total consumer product.
It's quite closer to 5.
$5 million?
Yes, it was closer to 5.
And again, that $5 million carries significant cost to it, too. There's no margin in that $5 million.
I thought so all along because I heard in the past that pretty much every division was profitable on its own, except for being a public company and now in the public company, and that probably was true as is. But now you're saying things have gone, they have deteriorated. So now they're losing money. It's a good choice. We can't have both generating the business. So okay, so $5 million from original, let's say, $5 million to $6 million from original NEXGEL will go into new NEXGEL. And you said that the assets that are coming over from Fountainhead are about $10 million run rate. But I was wondering, are these $10 million -- is this $10 million run rate basically wholesale kind of revenues? Because what I thought -- and forgive me, I'm -- Sequence was manufacturing products then apparently selling them to NEXGEL, then NEXGEL puts a markup, and then just Salesforce would sell them to final customers with a market. So when you say Sequence/Fountainhead, the other divisions are bringing in $10 million in revenues, are these final customer revenues or wholesale revenues, such that when they come into next -- into new NEXGEL, are these $10 million going to be $10 million? Or are they going to be sold as $15 million or even $17 million to final customers? I hope you understand my question.
Yes, I do. No, these are $10 million in sales to customers that don't include NEXGEL. So these are existing customers. We don't have any sales currently to NEXGEL because we had -- Sequence hasn't started selling product and manufacturing product yet, that will be taking place in the coming weeks as we finish the validation. So the $10 million that we our forecasting and first year revenues contributed by the Fountainhead companies are based on annualized or estimates of actual 2026. And I think it would be good to mention too, Sequence is going through the same suffering on the wound care side that NEXGEL is, and its sales and reimbursements are way down as well. What is nice is that Sequence is -- one of their products, their flagship product, Activate, is in the final stages of its clinical trial. And we're actually going to be attending the the Society of Advanced Wound Care Annual Meeting in Las Vegas in mid-October, where we'll be presenting interim data. And we're very comfortable that, that interim data is going to show a much better efficacy than the standard of care. And we're excited that we believe our final data should be ready and be published in the -- in several journals here by the end of the year. So we would be bringing an asset in that's currently going through a lot of the same suffering as NEXGEL, but we'll have the clinical evidence that is, we feel, is supported by the consensus statement that the CMS has referred everyone to for what they would consider appropriate level of evidence. So we're seeing the same things, but the answer to your question is the $10 million has -- there is no intercompany between NEXGEL and Sequence. This is all outside revenues that come in. And again, these are based off of current revenues, which are -- as we talk here in Fountainhead, are about as draconian as they can get.
Okay. And so how do we get from $5 million, $6 million original NEXGEL of revenues, plus $10 million Fountainhead revenues. How do we get to $21 million in year 1 run rate?
So we anticipate, based on our discussions with Arthrex, also the ability for Sequence to manufacture Interfyl for Arthrex, we're going to be able to not quite a significant back order down. As a matter of fact, when the transaction closed in April, there was already a $0.5 million back order on to Arthrex. And that is -- has grown by almost a factor of 3. I think we're right around 2.5x, almost 3x the backlog now. And that also allows for Arthrex. So we're making up that backlog and there's some additional Arthrex sales that hadn't been realized that we know are going to be realized because of manufacturing constraints. So that's kind of where we have it. And then the ocular business, the NEXGEL launch, excuse me, this year is included as well. Excuse me, I'm sorry. And that replaces some of the OTC consumer product business that was lost is this ocular business that has been launched by NEXGEL.
Well, this sounds wonderful. Actually, let me just summarize here. So original NEXGEL revenues of about $5 million, $6 million, plus Fountainhead revenues of $10 million, plus ocular, plus anticipated growth in new contracts. All this equals to about $21 million in expectations under safe harbor provisions and everything. Did I understand that correct?
Yes. What I would like to do is offer an opportunity to have an off-line conversation so that we can allow others to get some questions in, if they have any. But yes, I'd be more than happy to walk you through this and give you additional time to answer your question.
One last question. This is only 30 seconds or less. So in your financial calculations of what capital is needed. Have you factored in enough -- heavy factors is not the right way to put the question. But your calculations include the anticipated $10 million to $15 million that NEXGEL can potentially get from the sales of Silly George and the other assets. You said 3x sales approximately or Kevin said that. So I'm thinking if you sell $5 million worth of Silly George and other revenues, at 3x sales, this should bring $15 million of cash into new company NEXGEL. Did I get that correct?
No, I think Kevin had misspoke. I think he originally said sales, but then went back to correct himself and say it was 3x profits. And so...
But there are no profits?
Yes. And the profits are minimal, if not 0. So I would say that inventory, the value of the over-the-counter product lines would be minimal, with the exception of -- there would be some inventory, whatever the inventory would -- that we'd be able to sell. So that's why it's -- there's certainly more cost to carry that minimal profit that it makes sense. So the margins aren't great. The gross margins aren't great. And so we're not expecting to see significant revenue from that, but we do expect to have significant cost reduction that will more than offset the revenue.
Okay. Got it. I really appreciate your time and attention and carefully answering all these questions. I really appreciate it. Best of luck.
Thank you. At this time, we have no further questions in the queue.
Okay. Well, thank you, everyone, for your time and attention. Hopefully, we'll continue to move forward and make progress. And again, thank you for your time.
Thank you. This brings us to the end of today's meeting. We appreciate your time and participation. You may now disconnect.
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