BioStem Technologies Q4 2025 Earnings Call - BioTissue Acquisition Repositions Firm Toward Hospital Revenue to Offset Medicare Headwinds
Summary
BioStem used the Q4 call to announce a sharp strategic pivot. Management closed the BioTissue surgical and wound assets on January 21, 2026, and is reallocating sales and commercial resources toward hospital inpatient, HOPD, and ASC channels to reduce exposure to CMS-driven physician office reimbursement changes. The company reported solid Q4 product economics but flagged a one-time $8.8 million allowance tied to receivable stress at distributor Venture Medical and a pulled-forward cash position after the acquisition, leaving BioStem cash-constrained through much of 2026 unless it secures financing.
Clinical momentum is the other pillar. Management published top-line DFU randomized data showing BioREtain superiority and expects VLU top-line midyear, data they say will support hospital value analysis approvals and payer conversations. Integration and margin upside are explicit targets: a 12-month manufacturing supply agreement with BioTissue yields mid-60% gross margins today, with management forecasting a return to above 80% gross margins after tech transfer and in-house manufacturing, subject to milestone and royalty payments tied to the deal.
Key Takeaways
- BioStem reported Q4 2025 revenue of $10.1 million, nearly flat vs the prior period ($10.5M) but down from $22.7 million in Q4 2024.
- Q4 gross profit was $9.8 million, implying a 97% gross margin, up from 88% in the prior period and 84% in Q4 2024, driven by product mix favoring items without licensing fees.
- Operating expenses jumped to $17.3 million in Q4, primarily due to an $8.8 million allowance for potentially uncollectible receivables from distributor Venture Medical, tied to CMS payment delays and denials.
- Management closed the BioTissue surgical and wound asset acquisition on January 21, 2026, adding the Neox and Clarix product families and processing platforms CryoTek and SteriTek to BioStem’s BioREtain portfolio.
- The acquisition materially shifts the company toward hospital sites of care, including inpatient, HOPDs, and ASCs, diversifying away from the physician office and CMS-driven Medicare exposure.
- During a 12-month manufacturing supply agreement, acquired products are expected to carry gross margins of approximately 60% due to a 23% cost-plus markup to BioTissue.
- BioStem plans a technology transfer after the 12-month supply period and expects to bring manufacturing in-house at its Pompano Beach facility, targeting gross margins north of 80% for those products once fully integrated, net of royalty payments.
- The transaction structure includes a $15 million upfront component, a $10 million 510(k) milestone payment expected in the second half of 2026, and up to $15 million in potential royalty payments, per management commentary.
- Management guided Q1 2026 revenue to roughly $5.0 million to $6.0 million, reflecting the impact of physician office declines and the partial contribution from acquired assets starting Jan 21.
- BioStem’s cash was $29.5 million at end of Q4, falling to approximately $16 million after closing the BioTissue deal, and CFO expects cash runway, excluding the $10M milestone, into late Q3 2026 while the company is a net cash consumer this year.
- Company is actively seeking financing to fund commercial expansion and the $10 million 510(k) milestone, with management warning continued cash consumption through most of 2026.
- Clinical evidence is central to the strategy: management published DFU randomized controlled trial top-line results showing BioREtain superiority and expects VLU top-line mid-2026, data intended to support hospital value analysis committee approvals and payer coverage discussions.
- BioStem will deploy the acquired commercial footprint: >25 direct sales reps, >30 independent agents, existing GPO contracts, and plans to expand to at least 40 direct reps to accelerate hospital penetration and cross-sell product families.
- Management expects physician office revenue to be significantly lower in 2026 versus 2025, with stabilization and potential sequential improvement only in the second half of 2026 as clinicians adapt to CMS changes.
- KPMG was appointed independent auditor; management expects to finalize 2024 and 2025 audits soon as part of the Nasdaq uplisting plan, and welcomed Jodi Ungrodt as new audit committee chair.
- Commercial initiatives include launching BioREtain preserved dry products to hospital customers in Q2 2026, a pending medical device launch subject to FDA clearance, national medical education programs, and focused payer coverage efforts.
- Venture Medical will continue to serve physician office and mobile wound channels during the market transition, while BioStem concentrates internal resources on hospital-based growth.
- Management characterizes the acquisition as immediately accretive to hospital presence and commercially strategic, but warned of short-term revenue and cash volatility as physician office volumes re-price and integration costs are incurred.
Full Transcript
Abby, Conference 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 1 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 Philip Taylor with investor relations. You may begin.
Philip Taylor, Investor Relations, BioStem Technologies: 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.
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, Chairman and Chief Executive Officer, BioStem Technologies: Thank you, Tripp, 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.
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.
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 1, 2026, and the direct impact on practice economics as well as heightened documentation requirements and an ongoing threat of audits.
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.
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.
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.
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.
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.
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.
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.
Now, let me turn the call over to Barry, who will touch more on our growth drivers and our commercial strategy.
Barry Hassett, Chief Commercial Officer, 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.
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.
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.
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.
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, Chairman and Chief Executive Officer, 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.
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, Chief Financial Officer, 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.
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.
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.
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.
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.
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, Chairman and Chief Executive Officer, 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 CleRx 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.
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.
Abby, Conference Operator: Thank you, and we’ll now begin the question and answer session.
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.
Swayampakula Ramakanth (RK), Analyst, H.C. Wainwright & Co.: Thank you. This is RK from H.C. Wainwright & Co. 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, Chief Financial Officer, 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.
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.
Swayampakula Ramakanth (RK), Analyst, H.C. Wainwright & Co.: 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, Chairman and Chief Executive Officer, 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.
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.
Swayampakula Ramakanth (RK), Analyst, H.C. Wainwright & Co.: Okay. Thanks. I’ll step back into the queue. Thanks.
Abby, Conference Operator: Our next question comes from the line of Jeff Johnson with Baird. Your line is open.
Dane, Analyst, 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, Chief Financial Officer, BioStem Technologies: Yeah, Jason, 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 21. 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.
The $10 million payment that we expect to make, that’s tied to the milestone for a 510K 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.
To answer your question directly, I’d say late Q3 right now is really where we expect our cash to run to.
Dane, Analyst, 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, Chairman and Chief Executive Officer, 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 plus 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.
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, Chief Commercial Officer, 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.
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.
Abby, Conference Operator: Our final question comes from the line of Bruce Jackson with Benchmark. Your line is open.
Bruce Jackson, Analyst, 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, Chairman and Chief Executive Officer, BioStem Technologies: Thanks, Bruce, for your question. Brandon, I don’t know if you wanna jump in there.
Brandon Poe, Chief Financial Officer, BioStem Technologies: 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.
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 plus 80% for those specific products. That’s the intent right now, and we’re moving toward that.
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 510K, 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, Chairman and Chief Executive Officer, BioStem Technologies: Bruce, I’ll just add a little color on the operational side of things. Andrew Van Vliet, 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.
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, Analyst, 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, Chairman and Chief Executive Officer, 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, Analyst, Benchmark: All right. Thank you very much.
Jason Matuszewski, Chairman and Chief Executive Officer, BioStem Technologies: Thanks, Bruce.