Greetings. Welcome to the business update call for BioStem Technologies, Incorporated. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. Please note this conference is being recorded. I will now turn the conference over to Trip Taylor of Investor Relations. Thank you. You may begin.
Good morning, and thank you, everyone, for joining our conference call to discuss BioStem's business update. Leading the call today will be Jason Matuszewski, the company's Chairman and Chief Executive. We're also joined by Brandon Poe, the company's Chief Financial Officer, and Barry Hassett, the company's newly appointed Chief Commercial Officer. Before we begin, I'd like to remind everyone that our remarks may contain forward-looking statements based on management's current expectations.
These involve inherent risks and uncertainties that could cause actual results to differ materially from those indicated. These risks are described in our filings with the OTC Markets. You're cautioned not to place undue reliance on forward-looking statements, which speak only as of the date made. The company undertakes no obligation to update them unless required by law. With that, I'd now like to turn the call over to Jason.
Thank you, Trip, and good morning, everyone. Today marks an important milestone for BioStem, as last night we announced the successful completion of our acquisition of BioTissue Holdings' surgical and wound care business. This transaction doubles our addressable market by accelerating BioStem's entry into the acute wound care market with leading skin substitute products and a robust commercial infrastructure. The purchase of these assets underscores our stated commitment to building a market-leading advanced wound care business.
For BioStem, this is more than an acquisition. It's a transformation of scale, capability, and market reach. This transaction is a natural strategic fit that complements our legacy business and aligns with our long-term goals and core priorities, including diversifying our end markets, expanding our product portfolio, extending our geographic commercial footprint, and scaling operational excellence. This business is expected to be a catalyst to BioStem's growth and profitability in 2026.
Looking at the first priority, diversifying our end markets, this acquisition will expand our reach beyond core non-acute mobile and physician office-based wound care markets and will provide access to both chronic and acute wound care markets in hospital inpatient, outpatient, and ambulatory surgery center settings. Our new products are included on the major GPO contracts that we assumed as part of the transaction, serve high-value adjacent markets, including acute surgical wounds, burns, and soft tissue repair, and we expect will generate synergies that expand our product suite and diversify our payer mix and revenue streams. Importantly, as we move into adjacent markets, we are also de-risking our reimbursement headwinds and exposure to CMS's changes to payment in the physician office and mobile wound sites of care.
While we anticipate these non-acute markets to continue to be important for patients, the CMS reimbursement policy changes will benefit the acute setting since there is no longer a capped product and procedure pay structure. Now, reimbursement is on a per-square-centimeter basis at $127 per square centimeter, allowing for higher-quality, evidence-based products to be favored in the hospital setting no matter the size of the wound.
The addition of BioTissue's surgical business positions BioStem within the surgical and hospital-based market, a highly attractive growth channel with a large annual U.S. addressable opportunity across orthopedic, podiatric, plastic, and general surgical indications. Together with our legacy business, this expansion more than doubles our overall market opportunity. We believe that we have the right strategy and the right team in place to further our market penetration and deliver growth over time.
Focusing on our next priority, expanding our product portfolio, BioTissue's comprehensive surgical and wound care offerings will be integrated into BioStem's portfolio. The acquired assets, including the NEOX and Clarix product families, two of the most recognized amniotic and umbilical-derived allograft brands in surgical and wound care today, NEOX products, including NEOX 1K, NEOX RT, and NEOX FLO, are optimized for chronic and acute wound care, particularly in complex hospital cases and surgical applications .
Clarix products, such as Clarix 1K, Clarix 100, and Clarix FLO, are primarily used in recon, orthopedic, and podiatric surgeries, offering regenerative solutions designed to enhance tissue repair and to reduce post-operative inflammation and scarring. Together, these products generated approximately $29 million in 2025 revenue with industry-standard gross margins of 65% and provide a strong foundation from which we believe we can build and drive growth.
Importantly, this revenue is supported by a strong body of clinical and technical evidence. These newly acquired products have a strong foundation of published data that highlights the unique advantages of the core technology as well as its clinical performance. We are excited to be adding this technical and clinical data to our expanding library. In fact, post-acquisition, we now have three industry-leading proprietary technologies that offer unique benefits to the market: BioRetain, CryoTek, and SteriTek. We remain committed to demonstrating the advantage of these technologies both technically and in terms of clinical performance in patients. Looking at the third priority, extending our commercial footprint, to lead this next phase of growth, I am very pleased to announce that we have appointed Barry Hassett as our Chief Commercial Officer.
Barry brings a deep industry experience and strong track record of launching and establishing new technologies and building high-performance commercial teams in medical technology and regenerative therapies, and we believe that he is well-positioned to lead our team into this next phase of commercial growth. With the acquisition, we expect to significantly extend our commercial footprint and national reach through the integration of BioTissue's experienced national sales force, including both direct sales representatives and independent sales agents. The acquisition also includes assignment of prominent group purchasing organization contracts, or GPOs, giving us access to major GPO networks and immediately strengthening our presence across hospital inpatient, outpatient, and ambulatory surgery care settings.
The new national sales force team of approximately 20 direct sales representatives and more than 30 independent sales agents expands our internal commercial capabilities immediately and will be focused on hospital and surgical settings, immediately establishing our presence in the acute market and creating a foundation to reach new call points in urology, women's health, general surgery, and orthopedics, among a multitude of other specialties.
This sales force will be focused on acute settings with the ability to expand into non-acute over time. As we look ahead, our commercial strategy is structured to drive national growth through a multi-channel mode that expands BioStem's footprint across both acute and non-acute sites of care. In parallel, Venture Medical will continue to play an important role in our commercial strategy, serving the non-acute sites of care, including physician offices, mobile wound care providers, and alternate site channels.
As our business scales, our commercial model will evolve to support a broader, more flexible distribution structure in the non-acute market, allowing us to complement our long-standing partnership with Venture Medical with additional distribution relationships where appropriate. Anchored by this expanded commercial footprint and diversified channel strategy, BioStem is well-positioned to capture a meaningful share across the spectrum of wound care sites and settings. Turning to our final priority, operational excellence.
At BioStem, our vertically integrated manufacturing facility continues to deliver industry-leading margins and high-quality performance. As part of this acquisition, we entered into a manufacturing and supply agreement with BioTissue for the acquired products for a minimum of 12 months, after which time we intend to onboard the acquired products to our manufacturing facility. As we transition manufacturing in-house, we expect gross margin expansion while continuing to scale the business.
This plan reflects the strength of our quality systems, our operational discipline, and our readiness to scale production to meet future demand. Now, turning to the financial details of the transaction. Under the terms of this agreement, we acquired BioTissue's surgical and wound care business for an upfront cash payment of approximately $15 million for all purchased and licensed assets. There is also an additional regulatory milestone payment of up to $10 million payable upon the 510(k) clearance of a pipeline product. This clearance would add another clinically proven product to the BioStem portfolio that is ready to be commercialized. In addition, there are potentially royalty milestone payments equal to 7% of sales on the acquired products, up to $15 million. The royalty payments will only begin following the completed tech transfer of manufacturing from BioTissue to BioStem.
Notably, the acquired assets generated approximately $29 million in sales in 2025 and are expected to be growth and EBITDA accretive for BioStem in 2026. Post-closing, BioStem's cash and equivalents balance is approximately $16 million. We believe that our balance sheet remains strong and can support our future strategic initiatives. The financial profile of our business provides great options, and we will look to further bolster our balance sheet as we evaluate the optimal capital structure.
We are prepared to evaluate multiple options, including non-dilutive alternatives. In closing, this transaction advances our strategic plan, supporting market diversification, portfolio expansion, commercial growth, and scalable operational excellence. As we look to solidify a leadership position in the wound care market, we believe we are progressing toward our goal of supporting the full continuum of wound healing from acute surgical repair to chronic wounds.
I want to extend my gratitude to both BioStem and BioTissue teams for their professionalism and partnership throughout this transaction, and once again, congratulate Barry on his new role at this pivotal time for BioStem. Lastly, to those employees that are joining our team from BioTissue, I want to send out a special welcome to the team. I'm excited to have you as part of our team and excited about what we can accomplish together with the entire BioStem team. As we move forward, our team's focus remains on executing integration seamlessly, preserving strong financial discipline, and driving commercial excellence across the expanded portfolio. Operator, you may now open the line for questions.
Thank you. If you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. Our first question is from Ryan Zimmerman with BTIG. Please proceed.
Hi, good morning, everyone. This is Izzy on for Ryan. Thank you for taking the question. Just two for me. I was curious how you're thinking about the acquisition's impact on the composition of the current product portfolio, and just as a follow-up to that, what impact it might have on legacy product demand. Thanks for taking the questions.
Barry, I'll let you handle that one.
Sure, Jason. Yeah, thank you for the question. In terms of the current product portfolio, we really believe this is complementary. So our current portfolio is comprised of a single-layer amnion product and a full-thickness amniochorion. The BioTissue portfolio, while it does have a single-layer amnion, also has two full-thickness umbilical cord products, one that's cryopreserved and one that's terminally sterilized and can be stored at room temperature, as well as micronized products.
So this adds, we think, two important products to the mix that, again, we think will be complementary. Right now, our current sales are primarily in the office or exclusively in the mobile markets, and the BioTissue sales are almost exclusively in hospital settings. So we think that this is almost completely complementary across the board and that the broader portfolio is just going to put additional options on the menu, so to speak, for customers.
Our next question comes from Swayam Ramakanth with H.C. Wainwright & Co. Please proceed.
Good morning, Jason. Congratulations. This is RK from H.C. Wainwright. A couple of quick questions. The first one, as you said, you're pivoting towards the acute surgical suite with the acquisition of these products from BioTissue. So considering the changing CMS reimbursement environment, how should we think about the revenue mix or the expected revenue mix between the outpatient wound clinics, which you service through BioStem, and the inpatient surgical business that you're getting, say, by the end of 2027? So I'm thinking like a couple of years down the line. How should we think about this mix?
Yeah, I'll take it. Thanks, RK, for the question. I appreciate it. And thanks for joining the call today. I'll try to touch base on a little bit of it, and then maybe if Barry wants to add a little bit more detail to it. As we stated, this asset suite is primarily situated in the, we'll call it, acute space. So in the hospital setting, in 2025, they generated just over $29 million in total sales. So it's a great team. It's a great set of assets. And we're really excited to look to push that forward as we look at how the new landscape unfolds.
And we're still continuing to work with Venture Medical in the physician office segment, in the mobile wound care segment, where these patients still need to be treated, and those patients aren't going away. We're going to continue on pushing on both ends. I don't know if strategically it's a pivot. It's more of broadening our ability to commercialize and provide best-in-class perinatal tissue products.
Perfect. And then with the acquisition, you're obviously getting the much looked out for, the GPO contracts through this acquisition. How does that help your legacy business? And I know it's too early, but in general, how should we think about the timeline when you can actually get to see the full value of the GMO, I mean, the GPO contracts that you're able to access now?
Yeah, I think today's day one. We're aggressively working to assign those agreements over and start that dialogue with the major GPO groups. And through that dialogue, like you asked, we'll look to expand that product portfolio to include our BioRetain products and give the folks in the field from BioTissue, as well as our existing channels, the opportunity to sell not only in the non-acute space but also in the acute space.
One last question from me, Jason. As you start this new relationship, obviously, the sales force headcount is also increasing incredibly. So in terms of cross-selling, how easy is it, and how quickly can that be integrated to get your products also into the bag of these folks who are coming on board?
I'll hand that one to Barry.
Yeah, thanks, Jason. So obviously, we want to put our current portfolio in the bags of the sales team. Our first priority is ensuring a smooth and seamless and quick integration. So our initial focus out of the gate is, frankly, business as usual with regard to Venture as the office and mobile market evolves and with regard to the newly acquired commercial team with regard to their hospital business. I think our expectation is that we will train them on our technology and how to position our technology with the CryoTech and SteriTech technologies and look to benefit from those synergies probably sometime in the second quarter of this year.
Thank you. Thank you, Jason and Barry, for taking all my questions. Appreciate it.
Thanks, RK.
Our next question is from Subbu Nambi with Guggenheim Securities. Please proceed.
Hi guys. This is Thomas on for Subbu. Thanks for taking our questions. I'll ask both of mine upfront. In terms of just beyond revenue and EBITDA contribution, what are the important KPIs that BioStem will be tracking over the next 12-24 months to measure the success of the acquisition? And then separately, what are the milestones we should be looking out for in terms of the tech transfer over the next 12 months or so? Thank you.
Barry, you want to take the KPIs on the sales channel side?
Sure. Again, I think it's hard not to prioritize revenue there, but I think market share preservation and expansion in both spaces are key KPIs for us, as well as expansion of the team. So one of the advantages here, one of the priorities for us, is to continue to invest in this business and expanding the team and creating an even more comprehensive footprint throughout the country. So I think that's probably another KPI for us here in the short term.
On the operational KPIs, when we look at having the ability to tech transfer these products, we, as you all know, have been following the story. We've been really good at being efficient on the manufacturing side, and so we're really excited once we're able to start looking at initiating the tech transfer and getting it into our facility.
Our team has been amazing at being lean and mean and making these products at great gross margins, and I think we are a leader in the gross margin category for manufacturing perinatal tissue products, so we think there's some creativeness definitely by moving once we're able to complete the tech transfer from the facility at BioTissue to here. The great thing, too, is BioTissue is local in the sense of they're down in Miami. We're here in Fort Lauderdale. So the ease and hopefully the ability to get that tech transfer completed should be pretty straightforward since it's geographically pretty close as well.
Great. Thanks so much, guys, and congrats on the deal.
Thank you.
Our next question is from Josh Jennings with TD Cowen. Please proceed.
Hi, good morning. I echo the congratulations on the transaction. I'm sorry if I missed some of this or if you're not disclosing, but I was hoping to just get a better sense of the breadth of BioTissue's sales organization that you're bringing under the BioStem roof and just any way to help us think about the current coverage of different regions in the United States and how, obviously, you'll be strategic in terms of expanding as you see fit, but maybe just how much coverage you have in the outpatient wound care channel as well as the acute channel.
I'll give that one to Barry. Thanks for asking the question, Josh. Appreciate it.
Yeah, Josh. So as far as the team that's coming on board, it's just over 20 people. From an overall commercial perspective, 18 of those are either direct salespeople or sales managers. And then there's a complementary team of more than 30 independent sales agencies. And those range from individual 1099s to groups that have multiple individuals anywhere from four to 10 or 15 folks. And in fact, there's at least one large group on the Gulf Coast of Florida that has an organization of well over 20 at this point in time. It's a broad national footprint. There are still definitely some gaps there, and that's kind of what I alluded to on one of the earlier questions with regard to expanding the team and filling some of those gaps. But this gives us a tremendous head start with a very experienced team.
Many of the folks on this team have been selling this technology for more than 10 years at this point in time. So it gives us a tremendous head start in that space. You talked about the outpatient wound care space. I assume you're referring to the hospital outpatient environment, and that's something that we're going to be watching closely. Much of BioTissue's business is currently in the acute space in the hospital, and the hospital, all of the growth, well, the vast majority of the growth, the explosive growth in outpatient wound care has been in the offices and the mobile space over the last few years.
One of the reasons for, well, the reimbursement drove that, and the capitated reimbursement in the hospital outpatient space also contributed to that. With the changes in payment this year, that changes the hospital outpatient environment. So that's something that we're going to be able to look to leverage with the BioTissue team. And we'll be watching closely in the market overall as some of this, some of the advanced or chronic wound care may shift back into the hospital outpatient space or at least see an increased rate of growth there.
Excellent. Thank you for that. And just was curious on the milestone payment, $10 million for achieving 510(k) clearance for a new product. Is there any details you can share just on is that for a specific development program under the BioTissue was working on, or is that for a suite of products? Again, I apologize if you already addressed that, but appreciate you taking the questions and congratulations.
Yeah, thanks, Josh. Yeah. So the BioTissue team back in September submitted for a 510(k) for their flow-based product. And so we're looking towards getting a 510(k) award and moving that product from 361 up to a device 510(k) regulatory framework.
As a reminder, if you would like to ask a question, it is star one on your telephone keypad. Our next question is from Bruce Jackson with The Benchmark Company. Please proceed.
Hi. Good morning and thanks for taking my questions. With the BioTissue product line, there's ocular and surgical. Can you give us a rough idea of what the mix is between those two product lines?
Thanks, Bruce. Thanks for joining the call. This acquisition is solely focused on the surgical wound care side of the BioTissue business. As we stated last year in 2025, that surgical wound care segment delivered just over $20 million in top-line revenue, excuse me, $29 million in top-line revenue.
Okay. I'm sorry. I needed some clarification there. So this is all the surgical business that we're getting right now, and also all the reps are then dedicated to the hospital surgical business.
That is correct.
Okay. Okay. Got it. And then with the commercial milestones with the royalty and everything, is there a bonus retention program for the reps?
Currently, there is a bonus retention program. The milestone activity or the milestone payments are predicated on a successful tech transfer. So when we move the manufacturing of the existing BioTissue products into our facility and that is successfully validated at our facility and we're able to actually manufacture that product and ship it, that's when that royalty is initiated. So obviously, as I alluded to earlier, there's some synergies around us internally manufacturing versus BioTissue continuing to manufacture it.
But through this acquisition, we've built a great partnership with the BioTissue leadership team as well as the operational team, and we're excited to have them support us in the interim, at least at a minimum of 12 months going forward. Then as we get closer to the end of that 12 months, we'll look to start that conversation around tech transfer and bringing the manufacturing expertise in-house and where we feel like there's definitely some synergies of improvement from the COGS perspective.
Okay. Great. That's it for me. Congratulations on the creative acquisition.
Thanks, Bruce. Appreciate it. Thank you for your time.
Our next question is from Mike Matson with Needham & Company. Please proceed.
Yeah. Thanks. Just a question on how you're financing the deal. I assume you're just using cash on your balance sheet. Is that correct? And can you give us a sense of kind of where things will end up once you close the deal?
Yeah. Brandon, do you want to take that one?
Yeah, I will. Thanks for the question, Mike. Yeah. We're going to fund this initial $15 million with cash on the balance sheet. And then we'll look at sort of what the right decisions are for the capital structure as we move into the later Q1 and Q2 of this year. This milestone payment of $10 million, we do expect sometime in 2026. So we'll be looking at the right decisions there to finance that as well, potentially.
Okay. Thanks. And then what about gross margins for the products that you guys are acquiring? Is it similar to your own gross margins?
Yeah, I'll take that too. So currently, we mentioned those products are in the 65% margin range. They'll probably be a little bit lower than that as we're purchasing those products from BioTissue as they continue to manufacture the products on our behalf. But we do expect after we get through tech transfer, 12 months or later than now, we do expect to get some benefit on the gross margin side. But currently, they're at about 65%.
Okay. Got it. Thanks.
Thanks, Mike.
With no further questions, I would like to turn the conference back over to management for closing remarks.
Thank you again to everybody for joining the call this morning. It was an earlier one for folks that are on the West Coast. As I said earlier, we're really excited about this transaction and looking forward to bringing the BioTissue folks and welcoming them to the stand. Thank you all for the time this morning.
Thank you. This will conclude today's conference. You may disconnect at this time, and thank you for your participation.