Q4 2025 BioStem Technologies Inc Earnings Call

March 24, 2026

Speaker #3: All lines have been placed on mute to prevent any background noise. After the speakers' 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.

Speaker #3: 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.

Speaker #3: You may begin. Good afternoon, everyone, and thank you for joining our conference call to discuss BIOSTEM's Q4 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 Po, the company's chief financial officer.

Philip Taylor: Good afternoon, everyone, and thank you for joining our conference call to discuss BioStem's Q4 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.

Speaker #3: Before we begin, I'd like to remind everyone that our

Speaker #1: 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.

Speaker #1: These risks are described in our filings with the OTC markets . You are cautioned not to undue reliance on forward looking statements , which speak only as of the date made .

Speaker #1: The company undertakes no obligation to update them unless required by law. Finally, this call also includes references to non-GAAP financial measures.

Speaker #1: 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.

Philip Taylor: 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.

Speaker #2: Thank you , 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 .

Jason Matuszewski: Thank you, Tripp, and good afternoon, everyone. Today, I'll focus on the progress we made through Q4 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.

Speaker #2: The addition of Bio-tissue 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 As a result , Biostim looks profoundly different today than it did just a few months ago .

Speaker #2: 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.

Speaker #2: When we talk about the hospital setting , it includes hospital inpatient , hospital , outpatient departments or opds and ambulatory surgery centers , or ASC customers .

Jason Matuszewski: 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 Q4 of 2025, our revenue consisted only of sales to the physician office customers. It was a solid finish to the year with Q4 revenue of $10.1 million.

Speaker #2: 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 Bio-Tissue. We addressed these two settings differently and have established a commercial structure to serve these sites of care.

Speaker #2: Most efficiently and effectively. Going forward, you will refer to the hospital business and the physician office business in the fourth quarter of 2025.

Speaker #2: 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 .

Speaker #2: Also , in the fourth quarter , we published top line results from our DFU clinical trial , demonstrating clear superiority of our bio retained 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 .

Jason Matuszewski: Also in Q4, 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 1 January 2026, and the direct impact on practice economics, as well as heightened documentation requirements and an ongoing threat of audits.

Jason Matuszewski: Also in Q4, 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 1st January 2026, and the direct impact on practice economics, as well as heightened documentation requirements and an ongoing threat of audits.

Speaker #2: The results from our randomized controlled trials support the clinical effectiveness of our BioRetained technology and position us extremely well across all sites of care.

Speaker #2: 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 .

Speaker #2: 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.

Jason Matuszewski: 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.

Speaker #2: 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 and more markets in the relentless pursuit of healing .

Speaker #2: We acquire Biotissue 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 for 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 .

Jason Matuszewski: 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.

Speaker #2: Our physician office business is the foundation on which Biostim 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 .

Speaker #2: 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.

Speaker #2: 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 .

Speaker #2: 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.

Jason Matuszewski: 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 sustained 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.

Speaker #2: 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 .

Speaker #2: The Niox and Clerics 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 , Niox and clerics introduce a new category of proprietary Cryopreserved wet tissue allografts to Biosim portfolio , distinct from our existing dry tissue and the vendor's product family , which is derived from our proprietary bio , retained technology .

Jason Matuszewski: 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 needs, 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 needs. 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.

Speaker #2: 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.

Speaker #2: The Niox and Clerics lines span a range of configurations designed to address the full spectrum of clinical need. Niox products are optimized for chronic wound care in complex hospital and surgical settings, while Clerics products are primarily used in reconstructive and surgical applications. Together, these product families expand our portfolio of placental and umbilical cord tissue.

Speaker #2: Allografts are 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 a million patients who have benefited from the technology.

Jason Matuszewski: 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: The recently acquired portfolio additions boast more than 25 years of clinical experience and more than a 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.

Speaker #2: With the addition of bio tissues processing technologies , Biostim now holds three proprietary platforms bio , retain , Triotech and stereo tech , positioning the company with a broader and more versatile technology stack across both dry and cryopreserved tissue products Third , and one of the most important strategic elements of this acquisition is the immediate extension of our commercial footprint .

Speaker #2: With access to the hospital care setting spearheaded by Barry Hassett, who has recently been appointed as our Chief Commercial Officer, we are in a stronger place than ever to execute on our long-term goals.

Speaker #2: Our commercial model is evolving into a broader, multi-channel strategy, as we are integrating bio tissues. We have an experienced national sales force of more than 25 direct sales representatives and managers, and more than 30 independent sales agents.

Speaker #2: 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.

Jason Matuszewski: 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.

Speaker #2: This expanded commercial infrastructure meaningfully increases our reach and positions us to compete in sites of care where we have historically had limited presence.

Speaker #2: Finally , this acquisition will to scale our operational excellence on the operational side , we have entered into a manufacturing and supply agreement with Bio-tissue for a minimum of 12 months post of the acquisition .

Speaker #2: This ensures continuity of supply and quality, as they will continue manufacturing the Clerics 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.

Jason Matuszewski: Importantly, the unit economics related to the tech transfer are extremely compelling for BioStem. Our gross margins on the acquired products during this twelve-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.

Speaker #2: 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 Bio-Tissue. BioStem's existing manufacturing operations have historically delivered margins in excess of 85%.

Speaker #2: 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 clerics and products.

Speaker #2: 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.

Speaker #2: 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.

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

Speaker #3: 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.

Barry Hassett: 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.

Speaker #3: 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 Biostim 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 .

Speaker #3: 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 .

Barry Hassett: 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.

Speaker #3: 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 .

Speaker #3: 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 Biostim presence across key call points mentioned earlier .

Barry Hassett: 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, 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.

Speaker #3: 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 , increasing patient access to our bio retained products .

Speaker #3: 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.

Speaker #3: The DFU study is a level one randomized controlled trial that demonstrated the statistically significant superiority of bio-retained, 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 VAX to authorize purchases.

Barry Hassett: 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 VA to authorize purchases. Separately, we will be initiating efforts to utilize this clinical data to expand commercial payer coverage. Lastly, advancing our product pipeline, we will launch our BioRetain preserved dry products through the new commercial team in Q2 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.

Speaker #3: Separately , we will be initiating efforts to utilize this clinical data to expand commercial payer coverage Lastly , advancing our product pipeline . We will launch our bio retain preserved dry products through the new commercial team .

Speaker #3: 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 clerics 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 .

Barry Hassett: 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.

Speaker #3: 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.

Speaker #2: 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 .

Jason Matuszewski: 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.

Speaker #2: The foundation we have built, including expanding commercial infrastructure, differentiating the product portfolio, and continuing to strengthen our clinical evidence. This foundation positions us well to capitalize on this $23 billion opportunity.

Speaker #2: Turning to our outlook, our hospital business is performing in line with historical levels of the acquired assets through our early integration activities.

Speaker #2: 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 .

Speaker #2: 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.

Jason Matuszewski: 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 H2 of 2026, paving the way for sequential revenue growth improvement. With that, I'll turn the call over to Brandon to walk through our Q4 financial results.

Speaker #2: 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.

Speaker #2: 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 results

Speaker #4: 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 .

Brandon Poe: Thanks, Jason, and good afternoon, everyone. Turning to our Q4 results, our revenue totaled $10.1 million compared to $10.5 million in the prior period and $22.7 million in Q4 2024. We were 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 Q4 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 Q4 2024. The sequential increase in gross margin was a result of a mix shift towards our products that do not carry a licensing fee.

Speaker #4: We're able to achieve revenue largely flat to the prior period , despite continued competition from higher priced products under the . ASP , plus 6% reimbursement model Gross profit for the fourth quarter was 9.8 million , representing gross margin of 97% , compared to 9.3 million in 80 8% in the prior period .

Speaker #4: And 19.1 million in 80 4% in the fourth quarter of 2020 . For the sequential increase in gross margin was the 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 .

Brandon Poe: Operating expenses for Q4 totaled $17.3 million compared to $7.8 million in the prior period and $10.6 million in Q4 2024. The sequential increase was primarily driven by $8.8 million in potential uncollectible accounts receivable due from our distributor, Venture Medical. During Q4, 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.

Speaker #4: 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.

Speaker #4: 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.

Speaker #4: 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 and for accounts where CMS reduces or outright denies claims .

Brandon Poe: 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 will take steps to collect on this balance in the future. The Q4 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 Q4 compared to $27.2 million at the end of the prior period.

Speaker #4: 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 will take steps to collect on this balance in the future.

Speaker #4: 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.

Speaker #4: In other operating expenses , sequential increases in legal costs and commercial headcount to support the Bio-tissue 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 Bio-tissue asset acquisition on January 21st , 2026 , our cash and cash equivalents balance was approximately 16 million .

Brandon Poe: Following the closing of the BioTissue asset acquisition on 21 January 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 21 January start date and the physician office being down significantly, as Jason noted, we anticipate Q1 revenue to be in the range of $5 to 6 million. In H2, 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.

Speaker #4: 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.

Speaker #4: 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 21st start date, and the physician office being down significantly.

Speaker #4: As Jason noted . We anticipate Q1 revenue to be in the range of 5 to $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 , and 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 .

Brandon Poe: With the physician office market expected to stabilize in H2, 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.

Speaker #4: We are confident that our newly diversified business includes all the foundational elements to support market share gains and drive biostim towards category leadership .

Speaker #4: 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.

Speaker #4: This important step toward our planned Nasdaq listing is progressing as expected, and we will provide updates as key milestones are reached. Lastly, for my comments, I would like to welcome Jodie to BioStem.

Speaker #4: Jodie has recently joined our Board of Directors and has stepped into the role of the Audit Committee Chairperson. Jodie 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.

Brandon Poe: 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 throw the call back to Jason.

Speaker #4: I am personally excited to have Jodie 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 Jodie's appointment. With that, I'll turn the call back to Jason.

Speaker #2: 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 Niox and clerics 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 Biochem 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 .

Jason Matuszewski: 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.

Speaker #2: Dynamics We will leverage our commercial strategy , including expanding our Salesforce 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 .

Jason Matuszewski: 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.

Jason Matuszewski: 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.

Speaker #2: 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 operations.

Speaker #2: You may now open the line for questions .

Speaker #5: 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.

Operator: Thank you. 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.

Speaker #5: 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 .

Speaker #5: 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 .

Speaker #5: And our first question comes from the line of Swayam Cooler with H.C. Wainwright. Your line is open.

Speaker #6: Thank you . This is RK from right . Good afternoon , Jason and Brandon So a couple of quick questions . You know the first one being on the on the .

Swayampakula Ramakanth: Thank you. This is RK from H.C. Wainwright. Good afternoon, Jason and Brandon. 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?

Speaker #6: Bio tissue accretion part of it . You know with with with bio tissue , surgical assets generating about 29,000,000 in 2025 and given , 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

Speaker #4: Yeah . Hey , okay , this is Brandon . I'll try and take that question . So I think we said previously that that 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 .

Brandon Poe: Yeah. 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.

Speaker #4: Now , you know that obviously doesn't include , you know , the support functions like finance or HR or other G&A type functions .

Speaker #4: So I think generally we feel like that business , you know , really currently is EBITDA positive based on , you know , what we brought over .

Speaker #4: And I think, over time, we'll continue to leverage that to cover the fixed costs of some of those overhead components that I just mentioned.

Speaker #4: So that's kind of where we are . We're not , we're not really giving guidance for 2026 . And we talked about Q1 simply because where we are , but that's how we think about the profitability of that business right now .

Brandon Poe: 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.

Speaker #6: Okay . And then on just for a second question on the on the vendor , he now that the vendor he 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 , for that to move to the covered status , let's say in 2027 .

Swayampakula Ramakanth: 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.

Speaker #6: You know , cycle You know , just , just so that we understand , you know , what you'll be able to get a better reimbursement number

Speaker #7: Yeah , I can , I can take that . Okay . Jason here , you know , when we're looking at what was considered status quo or covered or not covered from a , from an LCD perspective , that LCD ultimately was rescinded .

Jason Matuszewski: 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-

Speaker #7: And so 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 .

Jason Matuszewski: 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, NCD, or coverage policy that CMS decides to create. We also realize that process is going to 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.

Speaker #7: Near term in the next few months , as well as top line results of the Vlu study that data . We we feel strongly can can support whatever the new potential LCD or NCD or coverage policy that CMS decides to create .

Speaker #7: But we also realize that that process is going to require the full commenting period, as well as previous LCDs. So we don't anticipate, I guess, anything coming.

Speaker #7: An LCD effective by year end because we'll still need to go through that whole LCD approval process . But 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 , mid to late this year will support a status of covered versus status quo .

Jason Matuszewski: 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.

Speaker #7: If that's even, frankly, an option. By CMS.

Speaker #6: Okay, thanks. I'll step back and step back into the queue. Thanks.

Swayampakula Ramakanth: Okay. Thanks. I'll step back into the queue. Thanks.

Speaker #5: And our next question comes from the line of Jeff Johnson with Baird. Your line is open.

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

Speaker #8: Hey , guys . Good afternoon . This is Dan on for Jeff . Maybe I'll go back to a little bit . Brandon's comments about about the outlook here and maybe I'll be a little bit more focused on the cash flow side , but , you know , talking about after the close of the bio tissue being at 16 million , obviously it looks like gross margins will step down with those bio tissue assets being a greater percentage of the business .

[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?

Speaker #8: And then investing more in the the expanded sales force going direct . And then potentially even the , the one time $10 million payment , I believe , pending that FDA clearance .

Speaker #8: So just kind of, where do you sit from a cash flow runway standpoint, where you sit right now?

Speaker #4: Yeah . Jason , I can do that . Yeah . Thanks for the question . Is Brandon . Yeah . So , so yeah , you're right .

Brandon Poe: Yeah. Jason, I can hit that. Yeah, thanks for the question. This is Brandon. Yeah, so yeah, you're right. We were $16 million. That is where we were. We closed the deal on 21 January 2024. 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 going to see us consume cash here for the majority of 2026. From a runway perspective, and I'm excluding the $10 million payment you just referenced.

Speaker #4: We're 16 million is where we were when we closed the deal in January 21st . You know , I'd say we're , you know , by the end of Q1 , we'll be , we'll be a little bit below that .

Speaker #4: We're currently , you know , a consumer of cash generally . And that's , that's largely due to , you know , the , the physician office business dropping off pretty significantly in Q1 due to the changes that we've seen through CMS and the reimbursement .

Speaker #4: And so I think you're going to see us consume cash here for the majority of 2026 . So from a runway perspective , and I'm excluding the $10 million payment , you just referenced , you we've got cash .

Brandon Poe: 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 510(k) clearance, that's connected to our BioTissue asset acquisition. You know, our expectations right now is that'll be later, probably H2 2026, and that could obviously change that situation. We're actively, just so you're aware, looking at opportunities to bring cash into the business.

Speaker #4: Certainly in the late Q3 or longer , certainly no earlier than Q3 and the $10 million payment that we expect to make . And that's that's tied to the for those tied to the milestone , for a 510 K clearance that's our bio tissue asset acquisition , you know , our expectations right now is that'll be later , probably second half of 2026 .

Speaker #4: And that could call into that that that could obviously change that situation where we're actively just so you're aware , we're actively looking at opportunities to bring cash into the business .

Speaker #4: 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 .

Brandon Poe: 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 what 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.

Speaker #4: And that's, that's really where we're looking for some additional financing. But to answer your question directly, I'd say late Q3 right now is where they would expect our cash to run to.

Speaker #8: Okay , that's helpful . Yeah . And then maybe were you were 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 ?

[Analyst] (Baird): Okay, that's helpful. Yeah, 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? Any early insights that you've gained just in the first two months here, since closing that deal? Thanks, guys.

Speaker #8: Thanks , guys

Speaker #7: Yeah , we actually have Barry Hassett on the call as well today . So I'm going to extend that question over to Barry to to address .

Jason Matuszewski: Yeah. We actually have Barry Hassett on the call as well today. 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 back then, the BioTissue team at the time of ASP plus six and some of the other reimbursement methodologies never had access to sell a higher ASP product into the physician office segment. They're somewhat restricted to the hospital segment as well as the ambulatory surgery center and the OR, and what attracted us to acquiring them, those assets.

Speaker #7: But just on a high level, we've really seen initially some good success and excitement from the bio team that came over in the transaction.

Speaker #7: And we , we feel there's a high degree of promise associated with it . If you guys remember back words , the Bio-tissue team at the time of ASP plus six and some of the other reimbursement methodologies , never had an access to sell a higher ASP product into the physician office segment .

Speaker #7: So they're somewhat constricted to the hospital segment as well as the surgery center and the Or . And what attracted us to to acquiring them , those assets .

Speaker #7: And so, when we look at, you know, kind of creating neutrality around pricing, it really lends—they have built in the hospital outpatient as well as the O.R.

Jason Matuszewski: When we look at, you know, kind of creating neutrality around pricing, it really lends what they 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. But I'll hand it over to Barry to add a little bit more color there.

Speaker #7: and ASCs to extend our existing product lines , as well as the core Niox and clerics , product families to support adoption of those products in a physician office segment .

Speaker #7: So but I'll hand it over to Barry to , to add a little bit more color there . Yeah .

Barry Hassett: 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.

Speaker #3: Jason , I think you hit on all the right points as far as the Bio-tissue team , not really previously having the opportunity to sell heavily into the office setting because of where the price positioning was .

Speaker #3: And now the market being neutralized there . So , you know , we view this very positively because they have a lot of relationships in that space .

Speaker #3: 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 .

Speaker #3: That's across the entire segment . All of the all of the companies in this space are reporting that . And there's been a pullback on the use of skin substitutes in that space as it absorbs the new reimbursement or new payment environment .

Barry Hassett: There's been a pullback on the use of skin substitutes in that space as it absorbs the new payment environment and kind of figures out how it's going to 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.

Speaker #3: And kind of figures out how it's going to move , how it's going to 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 .

Speaker #5: And our final question comes from the line of Bruce Jackson with benchmark . Your line is open .

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

Speaker #9: Hi , thanks for taking my questions . I wanted to go back to the gross margins with bringing the bio products in-house . When do you think you can have those products in-house ?

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

Speaker #9: And then how do the gross margins expand from there ? How long is it going to take to get back up to the 85% range

Barry Hassett: Jason?

Speaker #7: Thanks , Bruce , for your question , Brandon , I don't know if you want to jump in there .

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

Speaker #4: Yeah , yeah , I can I can . This is Brandon . Bruce , thanks for the question . Yeah , so , you know , Jason mentioned on the call , you know , 60% is gross margins is where we see it now .

Brandon Poe: This is Brandon. Bruce, thanks for the question. You know, Jason mentioned on the call, you know, 60% is gross margins 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 that 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.

Speaker #4: That's , that's really impacted by the markup that we're paying for the service to buy tissue to continue to manufacture the products on our behalf .

Speaker #4: When that goes away , not only do we do we recoup sort of that markup , but we also feel like we've got we've got a vertically integrated facility .

Speaker #4: You know , we know how to make these products . We're very good at it . We've shown it over the past . So not only do we lose the markup , we also think that we can do it more efficiently .

Speaker #4: We know their cogs and you know our cogs for very similar products are less , frankly . So I think , you know , our expectation is that after one year , that's what the manufacturing of the tech transfer agreement .

Brandon Poe: 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 what the manufacturing of 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, but shortly after the one-year anniversary, we'll bring that in-house. You know, we've got expectations that we get back up to +80% for those specific products. That's the intent right now, and we're moving toward that.

Speaker #4: Allows us to bring that in-house . And 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 .

Speaker #4: Our expectation is that , you know , sometime mid Q1 or shortly after the one year anniversary , we'll bring that in-house . And , you know , we've got expectations that we get back up to plus 80% for those specific products .

Speaker #4: 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.

Brandon Poe: 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.

Speaker #4: So again , the upfront , 10 million for the 510 K , and then there's an up to $15 million royalty payment . But even with that royalty payment , which at some point will go away , we still feel like we can get close to that 80% gross margin pretty quickly in 2027 .

Speaker #7: And I'll just add a little color just to add a little color on the operational side of things . So , Andrew , remember our CEO 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 , and CapEx and requirements and things of that nature that we need for our facility to support manufacturing the clerics and the family products and really working with the Biotissue team as well .

Jason Matuszewski: Bruce, I'll just add a little color on the operational side of things. Andrew Vembu, 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, 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.

Speaker #7: 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.

Speaker #7: And so that's kind of been our goal and why we've 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 , those gross margins

Jason Matuszewski: 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.

Speaker #9: Okay , great . And then my follow up on the Vlu study last quarter , you said it was recruiting a little bit faster than expected .

Bruce Jackson: 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 gonna have that one wrapped up? Thank you.

Speaker #9: When do you think you're going to have that one wrapped up ? Thank you

Jason Matuszewski: 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, so 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.

Speaker #7: I think last quarter we were we were seeing good enrollment in Q3 . In Q4 , we actually had a little bit of slower enrollment in the study .

Speaker #7: So we're still targeting to try to get a top line readout here in the middle of this year . But we did see a little bit of a slowdown in enrollment over the holidays in Q4

Speaker #9: All right . Thank you very much .

Bruce Jackson: All right. Thank you very much.

Speaker #7: Thanks , Bruce

Jason Matuszewski: Thanks, Bruce.

Operator: Ladies and gentlemen, that concludes our question-and-answer session and today's call. We thank you for your participation, and you may now disconnect.

Q4 2025 BioStem Technologies Inc Earnings Call

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