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Biostem Technologies New
3/24/2026
Abby Braden PhD.: : Ladies and gentlemen, thank you for standing by my name is abby and I will be your conference operator today. Abby Braden PhD.: : At this time, I would like to welcome everyone to the bio stem technologies fourth quarter and full year 2025 earnings conference call. Abby Braden PhD.: : All lines have been placed on mute to prevent any background noise after the speakers remarks, there will be a question and answer session. Abby Braden PhD.: : If you would like to ask a question during this time simply press star followed by the number one on your telephone keypad. If you would like to withdraw your question, press star one again. Thank you. And I would now like to turn the conference over to Tripp Taylor with Investor Relations. You may begin.
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 Matyszewski, 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 Matyszewski.
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 bioretained 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 bioretained technology and position us extremely well across all sites of care as the market begins to focus on the clinical benefit of products rather than price. As expected, transition for the treatment of Medicare patients is underway in early 2026, as clinicians are adjusting their patient management protocols in response to the payment changes instituted by CMS on January 1st, 2026, and the direct impact on practice economics, as well as heightened documentation requirements and an ongoing threat of audits. 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 and 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 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 Clerix 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 Clerics introduced a new category of proprietary cryopreserved wet tissue allografts to BioStem's portfolio, distinct from our existing dry tissue in the Vendahe product family, which is derived from our proprietary bioretained 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 Clerics 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 Clerix 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 a million patients that have benefited from the technology. With the addition of BioTissues 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, and 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 Biotissues Experience National Salesforce 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 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. 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%, 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 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.
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