BioStem Technologies Q4 2025 Earnings Call Transcript

Quartr
Provided by Quartr
March 24, 2026

Key Takeaways

  • Positive Sentiment: BioStem completed the BioTissue surgical & wound asset acquisition in January, immediately expanding its presence into hospital inpatient/outpatient and ASC channels and adding the Neox and Clarix product families to its portfolio.
  • Positive Sentiment: The company reported a DFU randomized controlled trial showing superiority of its BioREtain product versus standard of care, with VLU top-line results expected mid‑2026 — data the company says will support hospital value‑analysis approvals and payer coverage.
  • Negative Sentiment: Q4 revenue was $10.1M with a 97% gross margin, but operating expenses jumped to $17.3M largely due to an $8.8M reserve for potential uncollectible accounts tied to distributor Venture Medical delays/appeals, pressuring near‑term profitability.
  • Negative Sentiment: Post‑acquisition cash fell to approximately $16M and management says cash runway is into late Q3 2026 (excluding a potential $10M 510(k) milestone payment), and the company is actively seeking financing to fund commercial growth and that milestone.
  • Positive Sentiment: Operationally, BioStem has a 12‑month manufacturing agreement with BioTissue (acquired products currently at ~60% gross margin including a 23% markup) and plans a tech transfer to its Pompano Beach facility after 12 months to target >80% gross margins over time.
AI Generated. May Contain Errors.
Earnings Conference Call
BioStem Technologies Q4 2025
00:00 / 00:00

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Operator

Ladies and gentlemen, thank you for standing by. My name is Abby, and I will be your conference operator today. At this time, I would like to welcome everyone to the BioStem Technologies fourth quarter and full year 2025 earnings conference call. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question and answer session. If you would like to ask a question during this time, simply press star followed by the number one on your telephone keypad. If you would like to withdraw your question, press star one again. Thank you, and I would now like to turn the conference over to Trip Taylor with investor relations. You may begin.

Trip Taylor
Investor Relations Contact at Gilmartin Group

Good afternoon, everyone, and thank you for joining our conference call to discuss BioStem's fourth quarter 2025 financial results and corporate highlights. Leading the call today will be Jason Matuszewski, the company's Chairman and Chief Executive Officer, Barry Hassett, the company's Chief Commercial Officer, and Brandon Poe, the company's Chief Financial 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 are 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. Finally, this call also includes references to non-GAAP financial measures.

Trip Taylor
Investor Relations Contact at Gilmartin Group

A reconciliation to comparable GAAP measures and related information can be found in our earnings release posted on the investor relations section of BioStem's website. With that, I'd now like to turn the call over to Jason Matuszewski.

Jason Matuszewski
Jason Matuszewski
Chairman and CEO at BioStem Technologies

Thank you, Trip, and good afternoon, everyone. Today, I'll focus on the progress we made through the fourth quarter and more recently as we continue to diversify the overall business. The addition of BioTissue's Surgical and Wound assets in January has meaningfully diversified our business, expanded our presence in the hospital-based settings, and increased our exposure to commercially insured patient populations. We also reallocated our resources toward these sites of care, reducing our exposure to CMS reimbursement changes that are impacting the physician office setting. As a result, BioStem looks profoundly different today than it did just a few months ago. To start, it is important to explain how we now think about our business in terms of sites of care that represent different customers that we serve. Our two focus areas consist of the hospital setting and the physician office setting.

Jason Matuszewski
Jason Matuszewski
Chairman and CEO at BioStem Technologies

When we talk about the hospital setting, it includes hospital inpatient, hospital outpatient departments, or HOPDs, and ambulatory surgery centers, or ASC customers. When we talk about the physician office setting, it includes office and mobile wound care customers. Physician office made up the vast majority of our customer base prior to the acquisition of the BioTissue assets. We address these two settings differently and have established a commercial structure to serve these sites of care most efficiently and effectively. Going forward, you will hear us refer to the hospital business and the physician office business. In the fourth quarter of 2025, our revenue consisted only of sales to the physician office customers. It was a solid finish to the year with fourth quarter revenue of $10.1 million.

Jason Matuszewski
Jason Matuszewski
Chairman and CEO at BioStem Technologies

Also in the fourth quarter, we published top-line results from our DFU clinical trial, demonstrating clear superiority of our BioREtain process product over the standard of care. In the coming months, we expect to publish further analysis of the DFU trial and top-line results for our VLU study. The results from our randomized controlled trials support the clinical effectiveness of our BioREtain technology and position us extremely well across all sites of care as the market begins to focus on the clinical benefit of products rather than price. As expected, transition for the treatment of Medicare patients is underway in early 2026 as clinicians are adjusting their patient management protocols in response to the payment changes instituted by CMS on January 1st, 2026, and the direct impact on practice economics as well as heightened documentation requirements and an ongoing threat of audits.

Jason Matuszewski
Jason Matuszewski
Chairman and CEO at BioStem Technologies

As a result of these impacts to providers, physician office revenue will be significantly lower for 2026 versus 2025. The newly acquired product lines are performing as expected. Importantly, the demand we saw at year-end reinforces the underlying value of our clinically differentiated products, and we believe it is a positive indicator as patient flow in these settings works towards a new equilibrium. Now, I want to provide our view of our recent acquisition and our focus moving forward in 2026. Consistent with our long-term strategy to expand the business and offer more products in more markets in the relentless pursuit of healing, we acquired BioTissue's Surgical and Wound assets at the beginning of the year. Importantly, this combination meaningfully expands our business by diversifying our opportunity across multiple sites of care, growing our revenue streams with additional products, and broadening our payer mix.

Jason Matuszewski
Jason Matuszewski
Chairman and CEO at BioStem Technologies

I want to take a deeper dive into the strategic rationale for the acquisition and explore four core priorities that have shaped how we view the business, reinforcing our confidence in our strategic direction. First, we have significantly diversified our end markets. Our physician office business is the foundation on which BioStem was built. It encompasses our perinatal tissue allograft products serving patients with chronic wounds, primarily diabetic foot ulcers, venous leg ulcers, and pressure ulcers across physician office settings inclusive of mobile wound care. BioStem's next phase of growth is anchored in our hospital business with a clear focus on driving adoption across clinical specialties and expanding commercial payer coverage. This business includes products used in complex surgical cases across hospital inpatient, hospital outpatient, and ambulatory surgery center settings, providing access to procedures that are more commonly reimbursed by commercial insurers.

Jason Matuszewski
Jason Matuszewski
Chairman and CEO at BioStem Technologies

By deepening our presence in these settings and aligning with payer priorities, we are diversifying our revenue mix and unlocking new pathways for payer coverage. As we expand into additional sites of care, patient populations, and procedural applications, we are also meaningfully reducing our reliance on CMS-driven reimbursement in the physician office and mobile wound care settings. This diversification is particularly important in today's evolving reimbursement landscape, where commercial payer alignment and site of care flexibility are increasingly critical to sustain growth. Second, we have significantly expanded and differentiated our product portfolio. At the center of this acquisition are two well-recognized allograft brands in surgical and wound care, the Neox and Clarix product families. These products are supported by a strong body of published clinical and technical evidence and are widely adopted by physicians across the country.

Jason Matuszewski
Jason Matuszewski
Chairman and CEO at BioStem Technologies

Importantly, Neox and Clarix introduce a new category of proprietary, cryopreserved, wet tissue allografts to BioStem's portfolio, distinct from our existing dry tissue in the VENDAJE product family, which is derived from our proprietary BioREtain technology. This expands our capabilities across multiple tissue formats and provides physicians with differentiated options depending on the clinical need, handling preferences, and site of care requirements. The Neox and Clarix lines span a range of configurations designed to address the full spectrum of clinical need. Neox products are optimized for chronic wound care in complex hospital and surgical settings, while Clarix products are primarily used in reconstructive and surgical applications. Together, these product families expand our portfolio of placental and umbilical cord tissue allografts offered in cryopreserved, lyophilized, and room temperature form factors.

Jason Matuszewski
Jason Matuszewski
Chairman and CEO at BioStem Technologies

The recently acquired portfolio additions boast more than 25 years of clinical experience and more than 1 million patients that have benefited from the technology. With the addition of BioTissue's processing technologies, BioStem now holds three proprietary platforms, BioREtain, CryoTek, and SteriTek, positioning the company with a broader and more versatile technology stack across both dry and cryopreserved tissue products. Third, one of the most important strategic elements of this acquisition is the immediate extension of our commercial footprint with access to the hospital care setting. Spearheaded by Barry Hassett, who was recently appointed as our Chief Commercial Officer, we are in a stronger place than ever to execute on our long-term goals. Our commercial model is evolving into a broader multi-channel strategy as we are integrating BioTissue's experienced national sales force of more than 25 direct sales representatives and managers and more than 30 independent sales agents.

Jason Matuszewski
Jason Matuszewski
Chairman and CEO at BioStem Technologies

In addition, the reassignment of major GPO contracts provides immediate access to the hospital inpatient, outpatient, and ASC customers. While Barry will speak in more detail about how we plan to leverage this platform, at a high level, this expanded commercial infrastructure meaningfully increases our reach and positions us to compete in sites of care where we have historically had limited presence. Finally, this acquisition will allow us to scale our operational excellence. On the operational side, we have entered into a manufacturing and supply agreement with BioTissue for a minimum of 12 months post-close of the acquisition. This ensures continuity of supply and quality as they will continue manufacturing the Clarix and Neox products for us during the integration period. Following that 12-month period, we intend to execute a technology transfer and bring manufacturing of the acquired products to our in-house facility in Pompano Beach.

Jason Matuszewski
Jason Matuszewski
Chairman and CEO at BioStem Technologies

Importantly, the unit economics related to the tech transfer are extremely compelling for BioStem. Our gross margins on the acquired products during this 12-month supply period are expected to be approximately 60%. This gross margin includes the impact of a cost plus markup of 23% from BioTissue. BioStem's existing manufacturing operations have historically delivered margins in excess of 85%, among the highest in the industry for the past several years. As we bring these products in-house, we expect significant gross margin expansion on the production of Clarix and Neox products as we eliminate the markup and leverage our own vertically integrated manufacturing facility. This is expected to more than offset the future royalty payments and be an important driver of future profitability improvement as we scale the business.

Jason Matuszewski
Jason Matuszewski
Chairman and CEO at BioStem Technologies

Now, let me turn the call over to Barry, who will touch more on our growth drivers and our commercial strategy.

Barry Hassett
Barry Hassett
Chief Commercial Officer at BioStem Technologies

Thanks, Jason. At this point, we are allocating substantially all of our internal commercial resources toward the hospital and related sites of care, where reimbursement is heavily driven by commercial payers and there are stronger unit economics supporting the treatment of Medicare patients with chronic wounds. In parallel, we continue to partner with Venture Medical to serve the physician office and mobile settings that have been significantly impacted by recent Medicare payment changes as that market works through this transition. Following the acquisition, we now have a comprehensive product portfolio that positions BioStem with a strong foundation, as well as the opportunity to expand into a number of high-value surgical specialty markets, including orthopedics and sports medicine, particularly foot and ankle, urology and colorectal surgery, women's health, plus chronic wound care in the hospital outpatient setting.

Barry Hassett
Barry Hassett
Chief Commercial Officer at BioStem Technologies

Together, these segments represent a combined market opportunity of approximately $23 billion, and we believe our expanded universe of end markets enhances our ability to drive long-term growth. To capture this opportunity, we have identified several key strategic initiatives that we believe will support the continued execution of our commercial strategy and position the business to drive rapid and sustainable growth. These initiatives include expanding our sales force to broaden our geographic penetration, increasing medical education to accelerate adoption through peer-to-peer engagement, expanding payer coverage, and executing our product roadmap. Collectively, we believe these efforts will deepen market penetration, expand our customer base, and drive long-term revenue growth. First, from a sales force perspective, we currently have more than 25 direct sales representatives and managers, along with more than 30 independent sales agents providing national reach and supported by major GPO contract coverage.

Barry Hassett
Barry Hassett
Chief Commercial Officer at BioStem Technologies

Initially, this team will focus on hospital and surgical settings where we are establishing BioStem's presence across key call points mentioned earlier. As the year progresses, we anticipate continued ramping of the sales organization to include at least 40 direct representatives and additional independent sales agents to expand geographic coverage and our ability to serve additional hospitals and clinicians. Second, with regard to medical education, we are launching a comprehensive initiative, including national physician symposia, industry-sponsored professional society symposia, local dinner programs, and online webinars designed to offer peer-to-peer education delivered by experienced clinicians. Third, we are increasing patient access to our BioREtain products. The publication of our DFU and VLU studies positions us to drive adoption of our products through value analysis committee approvals at the hospital system level.

Barry Hassett
Barry Hassett
Chief Commercial Officer at BioStem Technologies

The DFU study is a level one randomized controlled trial that demonstrated the statistically significant superiority of BioREtain processed allografts when compared to standard of care under a very rigorous patient selection protocol and endpoint evaluation. This is the type of rigorous data required by VACs to authorize purchases. Separately, we will be initiating efforts to utilize this clinical data to expand commercial payer coverage. Lastly, we are advancing our product pipeline. We will launch our BioREtain preserved dry products through the new commercial team in the second quarter of 2026, exposing that portfolio of products to the hospital customer base. We also expect to launch a new medical device product pending clearance by the FDA, which is one of the key post-acquisition milestones that is part of our integration of the Neox and Clarix portfolios.

Barry Hassett
Barry Hassett
Chief Commercial Officer at BioStem Technologies

In parallel with all these activities in hospital-based sites of care, Venture Medical will continue to serve the physician offices, mobile wound care, and alternate site settings, such as long-term care facilities, where they have deep relationships and proven execution, as well as an ever-broadening portfolio of solutions to serve patients with chronic non-healing wounds. Now I'll turn the call back to Jason for our 2026 outlook.

Jason Matuszewski
Jason Matuszewski
Chairman and CEO at BioStem Technologies

Thanks, Barry. As you can see, we have taken meaningful steps to reposition the business, and we believe we are now operating from a position of strength with a clear and actionable path forward. The foundation we have built, including expanding commercial infrastructure, differentiating the product portfolio, and continuing to strengthen our clinical evidence foundation positions us well to capitalize on this $23 billion opportunity. Turning to our outlook, our hospital business is performing in line with historical levels of the acquired assets through our early integration activities. We believe there is a significant opportunity for growth in this business following the completion of the commercial organization integration and ramp in sales rep productivity as we execute our multifaceted growth strategy. In the physician office business, we believe the recent reimbursement changes will ultimately benefit BioStem.

Jason Matuszewski
Jason Matuszewski
Chairman and CEO at BioStem Technologies

We are confident in our ability to gain market share with our clinically validated products over the long term. In the near term, the confusion in the market is indicative that this substantial transition will take time to be digested and operationalized by clinicians. In the meantime, this has led to significant declines in our physician office business to date in Q1 versus Q4 of 2025. We expect the physician office market to stabilize in the second half of 2026, paving the way for sequential revenue growth improvement. With that, I'll turn the call over to Brandon to walk through our fourth quarter financial results.

Brandon Poe
Brandon Poe
CFO at BioStem Technologies

Thanks, Jason, and good afternoon, everyone. Turning to our fourth quarter results, our revenue totaled $10.1 million compared to $10.5 million in the prior period and $22.7 million in the fourth quarter of 2024. We're able to achieve revenue largely flat to the prior period, despite continued competition from higher priced products under the ASP +6% reimbursement model. Gross profit for the fourth quarter was $9.8 million, representing gross margin of 97% compared to $9.3 million and 88% in the prior period and $19.1 million and 84% in the fourth quarter of 2024. The sequential increase in gross margin was a result of a mix shift towards our products that do not carry a licensing fee.

Brandon Poe
Brandon Poe
CFO at BioStem Technologies

Operating expenses for the fourth quarter totaled $17.3 million, compared to $7.8 million in the prior period and $10.6 million in the fourth quarter of 2024. The sequential increase was primarily driven by $8.8 million in potential uncollectible accounts receivable due from our distributor, Venture Medical. During the fourth quarter, Venture saw a slowdown in payments from certain Venture customers due to delays or denials in payments by CMS to those customers. Ultimately, this resulted in a slowdown in payments from Venture to BioStem. In many cases, the amounts recorded for these potential uncollectible accounts are under active appeal. Our agreement with Venture allows for an extension of payment terms for those accounts that are under active appeal with CMS.

Brandon Poe
Brandon Poe
CFO at BioStem Technologies

For accounts where CMS reduces or outright denies claims, our agreement allows for a reduction in payment amounts by Venture to BioStem. We continue to monitor very closely the efforts made by Venture to resolve these outstanding potential uncollectible accounts, and we'll take steps to collect on this balance in the future. The fourth quarter allowance for uncollectible accounts is one time in nature, and we do not expect additional significant uncollectible accounts that would materially impact future results. In other operating expenses, sequential increases in legal costs and commercial headcount to support the BioTissue asset acquisition were partly offset by lower spend on our clinical trials. Moving to the balance sheet, our cash balance was $29.5 million at the end of the fourth quarter, compared to $27.2 million at the end of the prior period.

Brandon Poe
Brandon Poe
CFO at BioStem Technologies

Following the closing of the BioTissue asset acquisition on January 21, 2026, our cash and cash equivalents balance was approximately $16 million. Given that we are largely through the quarter, I want to add to Jason's comments and provide additional color on our outlook for Q1. In the quarter, the hospital business is performing in line with historical levels of the acquired assets. With the acquired assets being on track in Q1, adjusted for a January 21 start date and the physician office being down significantly, as Jason noted, we anticipate Q1 revenue to be in the range of $5 million-$6 million. In the second half of the year, after completing integration activities, expanding our sales force, and beginning execution on our strategic plan, we expect to drive sequential and year-over-year growth in the hospital business.

Brandon Poe
Brandon Poe
CFO at BioStem Technologies

With the physician office market expected to stabilize in the second half of the year, we see an opportunity for sequential revenue growth in that business. We are confident that our newly diversified business includes all the foundational elements to support market share gains and drive BioStem towards category leadership. I also want to provide a brief update on the status of our 2024 and 2025 financial audits. As you know, we appointed KPMG as our independent auditor in October of 2025, and they have been actively working to complete the independent audits for both fiscal years. We expect to finalize the audits in the very near future. This important step toward our planned Nasdaq uplisting is progressing as expected, and we will provide updates as key milestones are reached. Lastly, for my comments, I would like to welcome Jodi Ungrodt to BioStem.

Brandon Poe
Brandon Poe
CFO at BioStem Technologies

Jodi has recently joined our board of directors and has stepped into the role of the audit committee chairperson. Jodi is a seasoned advisor to life science companies and spent nearly three decades at Ernst & Young working with companies through initial public offerings, business combinations, and other transformative events. I am personally excited to have Jodi join the team, and I'm looking forward to working with her. Please refer to the press release that was published this past Monday for more information about Jodi's appointment. With that, I'll turn the call back to Jason.

Jason Matuszewski
Jason Matuszewski
Chairman and CEO at BioStem Technologies

Thanks, Brandon. As I look ahead to 2026, the hospital business is positioned to represent a strong majority of our revenue, supported by growing adoption of the Neox and Clarix portfolios across our expanding hospital and ASC channels. Our focus remains on diversifying our end markets, differentiating our product portfolio, and expanding our commercial footprint with access to the hospital care setting. BioStem has entered 2026 as a more diversified, hospital-focused business with increasing alignment to commercial reimbursement and reduced exposure to physician office and Medicare reimbursement dynamics. We will leverage our commercial strategy, including expanding our sales force to broaden our geographic penetration, increasing medical education to accelerate adoption through peer-to-peer engagement, expanding payer coverage, and executing our product roadmap.

Jason Matuszewski
Jason Matuszewski
Chairman and CEO at BioStem Technologies

With a broader product portfolio, expanded commercial reach, and strengthened operational foundation, we believe we are well-positioned to deliver more durable, sustainable growth and emerge as a market leader in advanced regenerative medicine. Operator, you may now open the line for questions.

Operator

Thank you, and we'll now begin the question and answer session.

Operator

If you have dialed in and would like to ask a question, please press star one on your telephone keypad to raise your hand and join the queue. If you would like to withdraw your question, press star one a second time. If you're called upon to ask your question and are listening via speakerphone on your device, please pick up your handset and ensure that your phone is not on mute when asking your question. To be able to take as many questions as possible, we ask that you please limit yourself to one question and one follow-up. Again, it is star one to join the queue. Our first question comes from the line of Swayampakula, Ramakanth with H.C. Wainwright. Your line is open.

Ramakanth Swayampakula
Ramakanth Swayampakula
Managing Director and Senior Equity Analyst at H.C. Wainwright

Thank you. This is RK from H.C. Wainwright. Good afternoon, Jason and Brandon. Just a couple of quick questions. You know, the first one being on the BioTissue accretion part of it. You know, with BioTissue surgical assets generating about $29 million in 2025, and given, you know, considering the upfront cost and also you bringing in 20 direct sales folks and integrating them, you know, when in 2026 do you think that segment would be EBITDA positive on a standalone basis?

Brandon Poe
Brandon Poe
CFO at BioStem Technologies

Hey, RK, it is Brandon. I'll try and take that question. I think we said previously that business, you know, when you look at what we brought over from a revenue perspective, the $29 million you mentioned, along with the team we brought over, you know, we felt like that was an EBITDA positive business, as a standalone. Now, you know, that obviously doesn't include, you know, the support functions like finance or HR or other G&A type functions. I think generally we feel like that business, you know, really it currently is EBITDA positive based on, you know, what we brought over. I think over time, you know, we'll continue to leverage that to cover the fixed costs of some of those overhead components that I just mentioned.

Brandon Poe
Brandon Poe
CFO at BioStem Technologies

That's kind of where we are. We're not really giving guidance for 2026, and we talked about Q1 simply 'cause where we are. That's how we think about the profitability of that business right now.

Ramakanth Swayampakula
Ramakanth Swayampakula
Managing Director and Senior Equity Analyst at H.C. Wainwright

Okay. Just for a second question on the VENDAJE. Now that the VENDAJE is placed in the 12-month status quo category, you know, can you give us some idea of what would be needed, you know, for that to move to the covered status, let's say in 2027, you know, cycle? You know, just so that we understand, you know, what you'll be able to get a better reimbursement number.

Jason Matuszewski
Jason Matuszewski
Chairman and CEO at BioStem Technologies

Yeah, I can take that, RK. Jason here. You know, when we're looking at what was considered status quo or covered or not covered from an LCD perspective, that LCD ultimately was rescinded. We continue to go forward on our clinical trials, the DFU study as well as the VLU study. As we mentioned in the call, we're looking to publish full readout of that DFU study here near term in the next few months, as well as top-line results of the VLU study. That data we feel strongly can support whatever the new potential LCD or NCD or coverage policy that CMS decides to create. But we also realize that that process is gonna require the full commenting period as well as previous LCDs.

Jason Matuszewski
Jason Matuszewski
Chairman and CEO at BioStem Technologies

We don't anticipate, I guess, anything coming an LCD effective by year end, because we'll still need to go through that whole LCD approval process. We also feel strongly that the data that was created and presented late last year on DFU as well as, you know, hopefully having VLU data at least top-line results mid to late this year will support a status of covered versus status quo if that's even frankly an option by CMS.

Ramakanth Swayampakula
Ramakanth Swayampakula
Managing Director and Senior Equity Analyst at H.C. Wainwright

Okay. Thanks. I'll step back into the queue. Thanks.

Operator

Our next question comes from the line of Jeff Johnson with Baird. Your line is open.

Analyst at Baird

Hey, guys. Good afternoon. This is Dane on for Jeff. Maybe I'll go back to a little bit Brandon's comments about the outlook here, and maybe I'll be a little bit more focused on the cash flow side. You know, talking about after the close of the BioTissue being at $16 million, obviously it looks like gross margins will step down with those BioTissue assets being a greater percentage of the business and then investing more in the expanded sales force going direct and then potentially even the one-time $10 million payment, I believe, pending that FDA clearance. Just kind of where do you sit from a cash flow runway standpoint, where you sit right now?

Brandon Poe
Brandon Poe
CFO at BioStem Technologies

Yeah, Jeff, I can take that. Yeah, thanks for the question. This is Brandon. So yeah, you're right. We're $16 million is where we were. We closed the deal on January 21st. You know, I'd say we're, you know, by the end of Q1 we'll be a little bit below that. We're currently, you know, a consumer of cash generally, and that's largely due to you know, the physician office business dropping off pretty significantly in Q1 due to the changes that we've seen through CMS and the reimbursement. I think you're gonna see us consume cash here for the majority of 2026. From a runway perspective, I'm excluding the $10 million payment you just referenced. You know, we've got cash certainly into late Q3 or longer, certainly no earlier than Q3.

Brandon Poe
Brandon Poe
CFO at BioStem Technologies

The $10 million payment that we expect to make, that's tied to the milestone for a 510(k) clearance, that's connected to our BioTissue asset acquisition. You know, our expectations right now is that'll be later, probably second half of 2026, and that could obviously change that situation. We're actively, just so you're aware, we're actively looking at opportunities to bring cash into the business, one, to finance that $10 million payment, but really ultimately to drive the commercial growth that we, you know, we referenced on the call about, you know, driving commercial growth, driving the hospital engine, and really supporting and driving that business. That's really where we're looking for some additional financing.

Brandon Poe
Brandon Poe
CFO at BioStem Technologies

To answer your question directly, I'd say late Q3 right now is really where we expect our cash to run to.

Analyst at Baird

Okay. That's helpful. Yeah, and then maybe where you ended off there, I mean, how do you guys see the cross-selling opportunity here between the hospital and the physician setting, and any early insights that you've gained just in the first two months here since closing that deal? Thanks, guys.

Jason Matuszewski
Jason Matuszewski
Chairman and CEO at BioStem Technologies

Yeah. We actually have Barry Hassett on the call as well today, so I'm gonna extend that question over to Barry to address. Just on a high level, we've really seen initially some good success and excitement from the BioTissue team that came over in the transaction. We feel there's a high degree of promise associated with it. If you guys remember backwards, the BioTissue team at the time of ASP +6 and some of the other reimbursement methodologies never had an access to sell a higher ASP product into the physician office segment. They're somewhat constricted to the hospital segment as well as the ambulatory surgery center and the OR and what attracted us to acquiring them, those assets.

Jason Matuszewski
Jason Matuszewski
Chairman and CEO at BioStem Technologies

When we look at, you know, kinda creating neutrality around pricing, it really lends to the relationships they've had built in the hospital outpatient as well as the OR and ASCs to extend our existing product lines as well as the core Neox and Clarix product families to support adoption of those products in a physician office segment. I'll hand it over to Barry to add a little bit more color there.

Barry Hassett
Barry Hassett
Chief Commercial Officer at BioStem Technologies

Yeah. Jason, I think you hit on all the right points as far as the BioTissue team not really previously having the opportunity to sell heavily into the office setting because of where the price positioning was, and now the market being neutralized there. You know, we view this very positively because they have a lot of relationships in that space, and we believe the two best technologies on the market to go out and go after that business. I think you need to consider, you know, as we mentioned, the physician office space is down right now. That's across the entire segment. All of the companies in this space are reporting that.

Barry Hassett
Barry Hassett
Chief Commercial Officer at BioStem Technologies

There's been a pullback on the use of skin substitutes in that space as it absorbs the new payment environment and kinda figures out how it's gonna move forward. In the meantime, we're keeping an eye out for potential uptick in patient treatment in the hospital outpatient space, specifically with regard to chronic wounds, because with the new CMS payment scenario, that outlook has actually improved, as we switched over from 2025 to 2026.

Operator

Our final question comes from the line of Bruce Jackson with Benchmark. Your line is open.

Bruce Jackson
Bruce Jackson
Equity Research Analyst of Healthcare Technology at Benchmark

Hi. Thanks for taking my questions. I wanted to go back to the gross margins with bringing the BioTissue products in-house. When do you think you're gonna have those products in-house? And then how do the gross margins expand from there? How long is it gonna take to get back up to the 85% range?

Jason Matuszewski
Jason Matuszewski
Chairman and CEO at BioStem Technologies

Thanks, Bruce, for your question. Brandon, I don't know if you wanna jump in there.

Brandon Poe
Brandon Poe
CFO at BioStem Technologies

Yeah, I can talk, again. This is Brandon, Bruce. Thanks for the question. Jason mentioned on the call, you know, 60% gross margins is where we see it now. That's really impacted by the markup that we're paying for the service to BioTissue to continue to manufacture the products on our behalf. When that goes away, not only do we recoup sort of that markup, but we also feel like, you know, we've got a vertically integrated facility. You know, we know how to make these products. We're very good at it. We've shown it over the past. Not only do we lose the markup, we also think that we can do it more efficiently. We know their COGS.

Brandon Poe
Brandon Poe
CFO at BioStem Technologies

Generally, you know, our COGS for very similar products are less, frankly. I think, you know, our expectation is that after one year, that's when the manufacturing or the tech transfer agreement allows us to bring that in-house. We've got a little bit of work to do on our side. Not a ton of work, but a little bit of work to bring that into our facility. Our expectation is that, you know, sometime mid Q1 or shortly after the one-year anniversary, we'll bring that in-house. We've got expectations that we get back up to p+80% for those specific products. That's the intent right now, and we're moving toward that.

Brandon Poe
Brandon Poe
CFO at BioStem Technologies

I mean, the one thing that goes against us a little bit is there is a royalty payment on the back end that we've talked about. Again, the $15 million up front, $10 million for the 510(k), and then there's an up to $15 million royalty payment. Even with that royalty payment, which at some point will go away, we still feel like we can get, you know, close to that 80% gross margin pretty quickly in 2027.

Jason Matuszewski
Jason Matuszewski
Chairman and CEO at BioStem Technologies

Bruce, I'll just add a little color on the operational side of things. Andrew Van Vurst, our COO and Co-Founder, has already been hard at work in putting the team in kind of an operational mode to look at how do we start thinking about tech transfer and what are the processes and CapEx and requirements and things of that nature that we need for our facility to support manufacturing the Clarix and Neox family products. Really working with the BioTissue team as well, we're looking to try to target that we have pretty much everything ready to set and go as soon as we hit that 12-month mark.

Jason Matuszewski
Jason Matuszewski
Chairman and CEO at BioStem Technologies

That's kind of been our goal and why we already started, you know, just a month or so into owning the assets, started those conversations about tech transfer and looking at, you know, how do we from operational perspective execute on a successful tech transfer and accelerate as fast as we can to improve those gross margins.

Bruce Jackson
Bruce Jackson
Equity Research Analyst of Healthcare Technology at Benchmark

Okay, great. My follow-up on the VLU study last quarter you said it was recruiting a little bit faster than expected. When do you think you're going to have that one wrapped up? Thank you.

Jason Matuszewski
Jason Matuszewski
Chairman and CEO at BioStem Technologies

I think last quarter, we were seeing good enrollment in Q3. In Q4, we actually had a little bit of slower enrollment in the VLU study. We're still targeting to try to get a top-line readout here in the middle of this year. We did see a little bit of a slowdown in enrollment over the holidays in Q4.

Bruce Jackson
Bruce Jackson
Equity Research Analyst of Healthcare Technology at Benchmark

All right. Thank you very much.

Jason Matuszewski
Jason Matuszewski
Chairman and CEO at BioStem Technologies

Thanks, Bruce.

Executives
    • Barry Hassett
      Barry Hassett
      Chief Commercial Officer
    • Brandon Poe
      Brandon Poe
      CFO
    • Jason Matuszewski
      Jason Matuszewski
      Chairman and CEO
Analysts
    • Bruce Jackson
      Equity Research Analyst of Healthcare Technology at Benchmark
    • Ramakanth Swayampakula
      Managing Director and Senior Equity Analyst at H.C. Wainwright
    • Trip Taylor
      Investor Relations Contact at Gilmartin Group
    • Analyst at Baird
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