Biostem Technologies - Earnings Call - Q4 2024

Transcript

Operator (participant)

Good day, everyone, and welcome to the BioStem Technologies fourth quarter and full year 2024 conference call. Just a reminder that today's call is being recorded. At this time, I would like to hand things over to Mr. Adam Holdsworth. Please go ahead.

Adam Holdsworth (Director of Investor Relations)

Good afternoon, everyone, and thank you for joining our conference call to discuss BioStem Technologies' fourth quarter and full year 2024 financial results and corporate highlights. Leading the call today will be Jason Matuszewski, the company's Founder and Chief Executive Officer, and Mike Fortunato, the company's Chief Financial Officer. Before we begin, I'd like to remind everyone that our remarks today may contain forward-looking statements based on the current expectations of management, which involve inherent risks and uncertainties that could cause actual results to differ materially from those indicated. These risks are described in the company's filings with the over-the-counter market. We are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date made and may change at any time.

While we may update or revise these statements from time to time, the company undertakes no commitment to do so unless required by applicable securities laws. This call also includes references to certain financial measures that are not calculated in accordance with generally accepted accounting principles, or GAAP. We generally refer to these as non-GAAP financial measures. Reconciliations of these non-GAAP financial measures to the most comparable GAAP measures are available in the company's earnings press release on the investor relations section of BioStem Technologies' website. With that, I'm now pleased to turn the call over to Jason Matuszewski. Jason?

Jason Matuszewski (CEO)

Thank you, Adam, and thank you all for joining us today. Before we begin today's call, I want to turn the call over to Mike to address the delay in our form 10 and the challenges we've encountered related to revenue and recognition under ASC 606. We believe that these are the remaining issues associated with allowing our form 10 to become effective.

Mike Fortunato (CFO)

Thanks, Jason. The accounting complexity surrounding our distribution agreement with Venture has required a significant amount of dialogue with our auditors and the SEC, particularly around the treatment of bona fide service fees paid to Venture. We believe there are three potential outcomes for our financial reporting going forward, depending on the final resolution. One, a gross revenue model with adjustments to the timing of revenue recognition based on sell-through to end-user positions. Two, a hybrid net model where a portion of the bona fide service fees are treated as pass-throughs and remain in sales and marketing expense. Three, a fully net model where all of the bona fide service fees are netted against revenue, which could materially impact reported revenue. We would not expect any material change to net income, adjusted EBITDA, or EPS as a result of these discussions or the SEC review process.

We are working diligently with our legal and accounting advisors to resolve this matter, and we remain confident in our underlying business fundamentals. We appreciate your patience as we complete this important step to ensure our form 10 is both accurate and aligned with all applicable guidance. I'll turn the call back over to Jason.

Jason Matuszewski (CEO)

Thanks, Mike. I'm proud to report a milestone quarter and year for BioStem Technologies. For Q4 2024, consistent with our current accounting policies, we achieved revenue of $102.9 million, a significant increase from $11.5 million in the same quarter of 2023. For the full year, revenue reached $301.8 million, reflecting robust market demand, successful nationwide launches, and strategic execution across our portfolio. Our strong gross margin of 95% underscores our focus on operational efficiency and scalability, particularly during the significant product launch such as that Vendaje AC. We delivered positive GAAP net income of $15.5 million this quarter and $37.9 million for the year, with adjusted EBITDA of $11.1 million for Q4 and $39.4 million for the year. These outstanding results were driven by strong adoption of our proprietary BioREtain technology powering AmnioWrap2 Vendaje AC.

I want to specifically recognize our partner, Venture Medical, for their instrumental role in accelerating our growth and commercial success. Looking ahead, our nationwide CMS-approved pricing forVendaje AC® positions us competitively for 2025. We continue to invest strategically in clinical validation efforts to substantiate the clinical superiority of our products, which we believe will continue to drive market penetration and payer coverage. Our first randomized clinical trials are underway in diabetic foot ulcers and venous leg ulcers, with initial data expected by mid-2025. In the policy landscape, we've actively engaged with CMS, congressional leaders, and industry stakeholders to advocate for fair reimbursement frameworks that balance patient access to the most innovative technologies and responsible utilization. We were pleased that this past Friday, CMS announced a second delay in the implementation of the local coverage determination policy. It has now been delayed until January 1 of 2026.

We remain confident that through continued dialogue with all stakeholders, the final resolution will be a positive outcome for patients, providers, payers, and the overall industry. On our uplisting strategy, we are working toward addressing the remaining SEC comments and finalizing necessary documentation. Our Nasdaq listing approval is contingent only on the effective form 10, which we anticipate soon. Uplisting to Nasdaq remains a pivotal milestone, broadening our access to institutional investors and enhancing our long-term shareholder value. I'll now turn the call over to Mike Fortunato for our more detailed financial review.

Mike Fortunato (CFO)

Thank you, Jason, and good afternoon, everyone. We appreciate you joining us today, and I will now present BioStem Technologies' fourth quarter 2024 and year-end financial results, which were a record achievement for the company. As I discussed earlier, these results are unaudited and reported consistent with our current accounting policies and are subject to change, which could be material based on our resolution of SEC comments and final closing of our year-end audit. For the fourth quarter of 2024, net revenue was $102.9 million compared to $11.5 million for the same period in 2023, reflecting an increase of $91.3 million year-over-year. This increase was driven primarily by the nationwide launch of Vendaje AC and continued market demand for AmnioWrap2.

Gross profit for the fourth quarter was $99.3 million, or 97% of net revenue, compared to $10.9 million, or 95% of net revenue for the same period in 2023, reflecting an increase of $88.4 million. This improvement was largely due to the nationwide launch of Vendaje AC and continued demand for AmnioWrap2. Operating expenses for the fourth quarter of 2024 were $90.9 million compared to $11.2 million for the fourth quarter of 2023, an increase of $79.7 million. The increase in operating expenses is primarily due to increased headcount, higher bona fide service fees driven by an increase in sales through our partner, Venture Medical, expenses associated with the launch of Vendaje AC, and increases in share-based compensation. We are also pleased to report that we achieved our fourth consecutive quarter of positive GAAP net income.

Net income for the fourth quarter was $15.5 million, or $0.94 per share, with an adjusted EBITDA of $11.1 million. Turning now to full year results, net revenue for 2024 was $301.8 million compared to $16.7 million for the same period in 2023, an increase of $285.1 million. This increase was driven primarily by the nationwide launch of Vendaje AC and continued market demand for AmnioWrap2. Gross profit for the 12-month period was $288.1 million, or 95% of net revenue, compared to $15.4 million, or 92% of net revenue for the same period last year, an increase of $272.7 million. This growth is primarily attributable to new sales volumes from the launch of Vendaje AC and the continued growth of AmnioWrap2. Operating expenses for the 12 months of 2024 were $256.9 million compared to $23.2 million for the same period last year, an increase of $233.7 million.

The increase is primarily due to higher costs related to scaling our operations, including workforce expansion, higher bona fide service fees driven by an increase in sales through our partner, Venture Medical, and increases in share-based compensation. Net income for fiscal 2024 was $31.9 million, or $1.95 per share, with an adjusted EBITDA of $39.4 million. In addition, our cash balance has increased from $14.6 million from the previous quarter to $22.8 million in the fourth quarter, an increase of $8.2 million. During the fourth quarter of 2024, we completed a detailed deferred tax study, including a Section 382 analysis, and confirmed that there were no limitations existing in our ability to use prior accumulated net operating loss carry forwards. As a result, we utilized 100% of our federal and Florida net operating loss carry forwards, totaling approximately $54.7 million.

The utilization of these loss carry forwards fully offset our income tax expense in the amount of $5.8 million recognized through September 30 and resulted in an additional income tax benefit of $7.1 million for the fourth quarter of 2024. The full year income tax benefit as a result of fully utilizing our net operating loss carry forwards was $1.3 million. As we look ahead to 2025, we are confident that these strong fourth quarter results, combined with the successful execution of our strategic initiatives, position BioStem Technologies for sustained growth and success. We remain focused on driving expansion, increasing profitability, and maximizing value for our shareholders. I'll now turn the call back over to Jason for an update on operational highlights.

Jason Matuszewski (CEO)

Thank you, Mike. As we close this record-breaking year, I want to briefly highlight four key pillars driving BioStem's continued success and what we are really excited about in 2025. First, our strong financial performance has positioned us exceptionally well. Additionally, our increased cash position has further strengthened our balance sheet, providing a solid financial foundation to support our ongoing strategic initiatives and future growth. Our cash balance has increased to $22.8 million at the end of Q4, up from $14.6 million in the previous quarter, reflecting an improvement of $8.2 million. Second, our nationwide launch of Vendaje AC®, alongside the continued market strength of AmnioWrap2™, represents a critical milestone in our commercial strategy. The CMS national pricing approval effective from Q4 has significantly expanded patient access across the U.S., further accelerating our growth trajectory in the chronic wound care market.

We are strategically focused on transitioning more customers to Vendaje AC for enhanced brand continuity within the Vendaje product family, while simultaneously reducing our SG&A expenses by eliminating licensing fees associated with AmnioWrap2, which we believe will ultimately improve our bottom line. Third, our commitment to clinical excellence remains strong. We are currently conducting three randomized controlled clinical trials. Our first trial, evaluating our BioREtain amnion chorion allograft for diabetic foot ulcers, has enrolled 75% of the patients to date, with enrollment to complete in the coming months. Our second trial, assessing amnion allograft for diabetic foot ulcers, began enrollment in January and has enrolled over 30% of the patients to date. Our third trial, recently IRB approved and enrolling patients, focuses on the non-healing venous leg ulcers.

Thirty-seven sites comprising of large institutions, academia, and clinical research sites are currently participating in these studies, with several more in process. These trials are progressing as planned, with early data readouts expected by mid to late 2025 and final results anticipated in early 2026. Fourth, we remain actively engaged with CMS, Congress, and industry stakeholders regarding CMS's local coverage determination policy through Project EPIC. Efficiency provides improved care. Project EPIC proposes a national framework designed to bring standardized regulatory and reimbursement regulation, improved patient access, and sustainable innovation to wound care. It seeks rescission of restrictive LCDs, stabilization through temporary payment freezes anchored to Q4 2024 ASP, and the eventual introduction of a national coverage determination and evidence-based reimbursement model that recognizes the benefits of superior products driving improved patient outcomes.

Notably, recent analysis published in the peer-reviewed Journal of Wound Care indicates that the proposed restrictive LCD could inadvertently increase Medicare Trust Fund expenditures significantly. Restricting treatments to an arbitrary number of applications over a fixed period could lead to higher rates of treatment failure, increased hospitalizations, amputations, emergency visits, and overall healthcare resource use, ultimately increasing Medicare expenditures by potentially hundreds of millions of dollars annually. Project EPIC provides a thoughtful alternative aimed at balancing cost containment, clinical flexibility, and optimized patient outcomes. Since publicly introducing Project EPIC, we have received overwhelming positive feedback from industry peers, policymakers, healthcare providers, and patient advocacy groups, all recognizing the potential of this balanced approach to improve patient access and accelerate innovation in wound care. There are two additional matters that I would like to provide further clarity on.

First, I want to address our announcement last November of the signing of a letter of intent to acquire commercial-stage products and development technologies from ProgenaCare Global. Following due diligence, we decided to pause the acquisition process, and as a lender, we are continuing to follow their progress. Moving forward, we remain actively engaged in evaluating opportunities for acquisitions, joint ventures, or other agreements that will expand our product portfolio and our market penetration. Secondly, I want to address the FDA warning letter we received dated January 17th of 2025 related to FDA's September 2023 inspection of our manufacturing facility in Pompano Beach, Florida. The warning letter cited observations concerning four injectable-based products, namely OROPRO, PROVISCUS, NEOFYL, and RHEO.

After the inspection, but before the warning letter, we had already ceased manufacturing and distribution of these four products as of late February 2024, which represented less than a quarter of 1% of our 2024 net revenue. In the warning letter, FDA explained that the agency determined these products did not qualify for regulation solely under Section 361 of the Public Health Service Act as tissue products, but were instead subject to regulation as a biological product. In response to the warning letter, we submitted a comprehensive written response to the FDA on February 10, 2025, outlining our plan for addressing all identified concerns. We reiterated our decision to discontinue the manufacturing and distribution of the four products and detailed corrective actions, enhancements to our quality management systems, and compliance measures aligning with FDA regulations for our current tissue product portfolio.

More importantly, our current products have received written confirmation from the Tissue Reference Group at the FDA that they meet Section 361 criteria, confirming the regulatory pathway for the current portfolio is considered a tissue product, while the observations cited in the warning letter, on the other hand, were issued under the regulations applicable to the manufacturing of drugs and biologic products. The warning letter citations are therefore not directly relevant to the products that we currently manufacture and distribute. However, we recognize that there are some similarities between the processing regulations for tissue products and manufacturing regulations for drug and biological products, and our corrective actions are designed to address these commonalities and opportunities for improvement. We continue to provide regular updates to the FDA on our progress and remain fully committed to maintaining the highest standards of product quality, safety, and regulatory compliance.

On the public company front, our pathway to uplisting to Nasdaq is clear and defined and progressing. We are actively addressing the SEC comments and finalizing the amended form 10 filings required for Nasdaq listing. We believe achieving this milestone will significantly enhance BioStem's visibility, credibility, and access to broader institutional investment, creating long-term shareholder value. Looking ahead to 2025, we are confident that the strategic initiatives we have established will sustain our strong momentum. We expect continued financial growth, further clinical validation, expanded payer coverage, and ongoing market penetration of our core products, AmnioWrap2 and Vendaje AC. We are also actively exploring opportunities to expand our advanced wound care portfolio and to launch our platform technology into complementary market sectors. I want to express my gratitude to our exceptional team at BioStem, as well as our trusted partner, Venture Medical.

Our shareholders and all our stakeholders who contribute daily to our vision of improving outcomes in patients with chronic wounds. With that, Operator, please open the line for questions.

Operator (participant)

Once again, everyone, if you would like to ask a question today, please press star one on your telephone keypad. Once again, it is star one if you have a question. I'll pause for just a moment to assemble the roster. We'll take our first question today from Swayampakula Ramakanth with H.C. Wainwright.

Swayampakula Ramakanth (Managing Director and Senior Healthcare Analyst)

Good afternoon. This is RK from HC Wainwright. How are you folks doing this afternoon?

Jason Matuszewski (CEO)

Good. RK, how's it going?

Swayampakula Ramakanth (Managing Director and Senior Healthcare Analyst)

Good, good. A couple of quick questions. The first one regarding trying to get the resolution on the bona fide service payments that you need to do to Venture. What sort of payments are these, and then how much is it going to impact your reported revenue lines? I know it's not easy to figure out with the regulatory bodies, but in general, what is your expectation in terms of timing for the upliftment?

Mike Fortunato (CFO)

Jason, do you want me to take that?

Jason Matuszewski (CEO)

Yep, go for it, Mike.

Mike Fortunato (CFO)

Sure, sure. Thanks for the question. Yeah, the basic issue here is the payments we make to Venture Medical are classified currently as sales and marketing expense and OpEx. The question that the SEC is asking is around whenever you make payments to a customer, the question becomes, is that a discount or is it for bona fide services or some distinct services they're providing? The way we've accounted for it, we believe they're distinct services. It's a sales and marketing engine for us in getting our goods to the end user customers. They're just going—it's highly technical. It's taking longer than I'd like, but we just submitted a response back to the SEC staff, I want to say, a couple of days ago, so I'm looking forward to hearing from them. At the end of the day, it's really geography on the income statement.

The question, essentially, the bona fide service fees you see in the sales and marketing expense, I think we actually have them separately classified. Those would move if the SEC says, "Look, you got to do this on a net revenue basis." Essentially, it would go against revenue. Revenue would come down by that amount, but also sales and marketing would come down. When we talk about net income, EBITDA, etc., not being affected, that's what we're talking about moving those costs up against revenue.

Swayampakula Ramakanth (Managing Director and Senior Healthcare Analyst)

Okay. It's either going to hit the gross margin or the operating margin. That.

Mike Fortunato (CFO)

It'll hit the gross margin in the sense that revenue would be decreased by the amount of the bona fide service fees. Yeah. It is not ideal, but the net income and EBITDA would be the same, so roughly.

Swayampakula Ramakanth (Managing Director and Senior Healthcare Analyst)

Okay, okay. I got it. In terms of the timing, do you have any idea?

Mike Fortunato (CFO)

We don't. I mean, I'd love to be able to tell you all. It's something I've been working on very hard, obviously. I think we're kind of at the beck and call of the SEC at this point, but we've kind of put forth our final best argument for why we believe it's correct the way it currently is. We're just waiting to hear back from them. I can tell you that the Nasdaq application has been submitted. There were a couple of comments that we had that we cleared with them. Once this is—we're clear with the SEC one way or the other, we should be good to go. I just don't have timing for you. I apologize.

Swayampakula Ramakanth (Managing Director and Senior Healthcare Analyst)

No issues. On the FDA letter itself, on the inspection letter and the clarifications that you have right now, because you are not really commercializing those products anymore, is that relevant at all in the sense are there any of those processes that you're doing right now for your other products that could be impacted by that same letter? Since you're not doing any production, that letter basically means nothing?

Jason Matuszewski (CEO)

Yeah. RK, I'll take that one. We just wanted to get it out and make sure everyone understood exactly what you just said, that when the FDA came and did the site inspection, we already were working towards discontinuing those products, and their focus on those injectable-based products are separate and distinct than our existing product line that we're commercializing today. We just wanted to make sure everyone understood that there really is no impact to the manufacturing operation of our facility based on this warning letter and that they were solely focused on those four injectable products and looking at it in the lens of a 351 or BLA or drug and biologic product versus how we manufacture products today, which is good tissue practices and towards AATB-accredited practices.

Swayampakula Ramakanth (Managing Director and Senior Healthcare Analyst)

Great. You ended the fourth quarter with $108 million. Even though you exited the year at $300-odd million for the year, can we analyze the fourth quarter number for 2025? Do you think how sustainable is that in general? If there is expectation for growth, what sort of expectation? What's the push and pull on that annualization number, basically?

Jason Matuszewski (CEO)

Right. Do you want to speak to that?

Mike Fortunato (CFO)

Yeah, sure, sure. I can speak to the revenue number. Just to be clear, the product is still selling. There's still volume. There's a lot of demand. The question then becomes, if we have to restate the revenue number, it'd probably be better to model on EBITDA versus revenue at this point, only because what would change would be the revenue number would come down by the same amount that the sales and marketing or bona fide service fee would be coming down. The economics are exactly the same. It's just the placement of the cost on the income statement. I don't know if that helps you or not. That's the way I kind of think about it. At the end of the day, it's a question of, does it go against revenue?

Swayampakula Ramakanth (Managing Director and Senior Healthcare Analyst)

That's not the question at all I'm asking. I'm just talking about the expectations for 2025. Let's assume everything is as is, like what you're just reporting. You reported like $104 million or so for the fourth quarter. Can we analyze it and expect somewhere north of $400 million for 2025? What's the push and pull on that?

Mike Fortunato (CFO)

Yeah. I mean, unfortunately, we don't like to—I mean, I'm not in a position to give guidance around that. I mean, Jason, I don't know if you want to give any more color on it, but without giving guidance.

Jason Matuszewski (CEO)

Yeah, RK, I think obviously having the LCD pushed to implementation in January 1 of 2026, I think that sets us up to continue our progress through 2025. We also mentioned that we are looking to have some data for our first DFU trial later this year as well. Like Mike said, currently, we do not extend guidance around where we are going. I think we are in a good position throughout 2025 to continue our progress.

Swayampakula Ramakanth (Managing Director and Senior Healthcare Analyst)

Okay. Perfect. Thank you. Thank you very much for taking all my questions.

Jason Matuszewski (CEO)

Thanks, RK.

Operator (participant)

The next question is Erik Voss, Mission Vertical.

Erik Voss (Research Analyst)

Hey, guys. Can you hear me?

Mike Fortunato (CFO)

Yep. We can hear you.

Erik Voss (Research Analyst)

Great. First of all, congratulations on a great year and a spectacular quarter. That was quite impressive. I'm wondering, just to start off again, just to reiterate, can you verify your earnings and EBITDA don't change in any of these scenarios that you're contemplating changing the top line to?

Mike Fortunato (CFO)

Yeah, yeah. I can take that, Jason. I mean, I think there could potentially be a small change if we go net—sorry, if we say gross, there could be a small change in the revenue with respect to—because currently, we're essentially recognizing revenue we sell to Venture Medical. The question would become from the SEC would be, look, if the end user is your customer, should you essentially recognize revenue when that stuff is sold through? I can tell you that the turnover is very fast. That number, if there is a decrease in revenue, would not be material. I think it could change slightly. We're not talking magnitudes of tons of money. We're just talking probably two weeks' worth of inventory or two weeks' worth of sales, potentially.

Erik Voss (Research Analyst)

Got it. What you said is earnings do not change. Earnings are going to—the earnings you guys report are the earnings.

Mike Fortunato (CFO)

Yeah. I mean, earnings would change only to the extent I do not think they materially change, I think is what we said. Basically, they could change a little bit, but I do not think they are going to materially change.

Erik Voss (Research Analyst)

Perfect. Okay. Can you help us with taxes then going forward? That $0.94 was on zero taxes or even a benefit. What should the effective tax rate be, Mike?

Mike Fortunato (CFO)

Yeah. We're estimating around 24% tax rate at this point.

Erik Voss (Research Analyst)

Okay. The tax rate?

Mike Fortunato (CFO)

Yeah, go ahead. Sorry.

Erik Voss (Research Analyst)

The tax rate in this quarter was zero?

Mike Fortunato (CFO)

Essentially, I think we had a benefit. It was like minus 2% or something like that because we had a little bit of an excess benefit that came through. Basically, the NOLs are all gone. We essentially used them all up for the 2024 earnings. Going forward, we're looking at ways to potentially reduce taxes, obviously, and make sure we're squared away there. We actually just engaged new tax advisors to help us in that regard.

Erik Voss (Research Analyst)

Okay. Perfect. Maybe going after the outlook for 2025 in a little bit different way, Jason, can you kind of comment or give us a sense for how distribution looks right now versus mid-year? I know that you guys were kind of focused on the West Coast and were moving to the East Coast. If you could talk maybe about penetration across the nation, penetration with podiatrists, and if and when you're in hospitals, we'd love to just get a sense for what ending you think this distribution story is in right now, Jason.

Jason Matuszewski (CEO)

Yeah. I mean, I think right now, like you mentioned, Eric, we initiated with Venture Medical, and we had a more higher concentration specifically on the West Coast and then also specifically in what we call the mobile wound care segment, looking at long-term care, skilled nursing, physician office, and smaller podiatry groups. Now, as we kind of cascaded through 2024 and into early 2025, and frankly, now with this LCD overhang kind of pushed back till the beginning of 2026, I think there's an opportunity just to really start looking at some larger organizations more on the East Coast, east of Mississippi.

We are in constant dialogue with the Venture team on how do we penetrate the geography of northeast and southeast regions, and then also to how do we expand our access to some of the groups that are in their, I'll call it, more hometown geography out on the West Coast and looking at some of the larger mobile wound care providers, etc. Mobile wound care is an expansive—it's had a lot of expansion over the last few years. It's definitely the largest revenue generator in regards to the pie of where our end physicians are located. Then kind of looking at where our organization seeks new opportunities is definitely getting into the hospital segment and also the ambulatory surgery center segment and hospital outpatient segment. Last but not least, into the VA and federal segment.

I think there's a lot of green field for us compared to our competitors, where I think there's a lot of opportunity that we have to tap into areas where, yes, there would be head-to-head competition, but at the same time, a lot of opportunity for us to really articulate our story about our BioREtain products and the product differentiation there.

Erik Voss (Research Analyst)

Yeah. That's fantastic. That's my final question. Thanks a lot, guys. Congratulations again.

Jason Matuszewski (CEO)

Thanks, Erik.

Erik Voss (Research Analyst)

Thanks.

Mike Fortunato (CFO)

Thanks.

Operator (participant)

Just a reminder, everyone, that is star one. If you have a question, we'll go to Mitchell Sacks Grand Slam.

Mitchell Sacks (Research Analyst)

Hey, guys. Two questions. One is, if we look at your revenue, where you go with kind of the worst-case scenario with the SEC saying the costs are going to be removed from revenue, what does your gross margin look like then on a percentage basis?

Mike Fortunato (CFO)

Yeah. Thanks for the question. Let me just look at something here really quick. I had something prepared for that. I think the easiest way to do this would be, if you think about the revenue, roughly 78%, I'll say 72-78% of that's going to come out of sales and marketing and into gross margin, into the gross margin line. Let me see if I have something here on that. I don't think I have it off the top of my head, but I can definitely, if you wanted to connect with me offline, I could definitely think about that. Let me see here. Hang on one second.

Mitchell Sacks (Research Analyst)

Sure.

Jason Matuszewski (CEO)

Yeah. Maybe the easier way to answer your question, Mitchell, is to look at, like Mike just said, we would just be moving up the bona fide services, SG&A, and netting it against top-line revenue in a worst-case scenario, and then ultimately then calculating gross margin from there.

Mike Fortunato (CFO)

Yeah. I'm sorry. I don't have the number off the top of my head, but we can definitely, to Jason's point, you'd just simply take the sales and the bona fide service fee out of the OpEx and jam it into as an offset to revenue and then rerun it.

Mitchell Sacks (Research Analyst)

Okay. My second question comes with respect to the revenue that was generated in the fourth quarter. I know you're not giving guidance. When I think about that just sort of more simplistically, is there any seasonality or is there anything that occurred in the quarter that skewed revenues to that quarter that would not be reappearing in future quarters? I don't know how to think about it, like one-time stocking kind of stuff, or is it just sort of a normal course of business for the fourth quarter? Is there any seasonality?

Jason Matuszewski (CEO)

Yeah. I mean, we get this question quite a bit, actually. Sadly, any sort of chronic wound does not have a season to it. I think we continue to push, the venture teams continue to push on getting product commercialized. I think maybe some uncertainty around the market in regards to where things go. If you guys do not know, the original LCD implementation date was February. I do not know, does that push providers to look at the use of skin substitutes prior to that date and make sure patients are getting treated with the appropriate products before they come off, the ability to have them may or may not address why was there broader adoption of the product. We do continue to kind of grow our customer base.

Kind of to my answer back to Eric, I think there's areas in which we didn't have tapped into at the beginning or middle of last year where we started to get access into later in the half of the year, more geographically on the East Coast versus the West Coast.

Mitchell Sacks (Research Analyst)

Okay. With respect to your customers, is there any kind of stocking, or is stuff just ordered as needed? In other words, how does that flow?

Jason Matuszewski (CEO)

Yeah. Kind of as Mike mentioned earlier, a lot of the material is flowed through. We do not have a situation where Venture takes possession and holds inventory for long periods of time. A lot of the material is sold through at a very rapid pace through to the end customer, which would be the physician.

Mitchell Sacks (Research Analyst)

Okay. In that situation, if we think about sales, what occurred in the fourth quarter, hopefully, you would be able to build on that in 2025. That would be your goal.

Jason Matuszewski (CEO)

That is correct.

Mitchell Sacks (Research Analyst)

Okay. That's good for me. Thank you.

Jason Matuszewski (CEO)

Thank you.

Operator (participant)

We will move to Dick Huebner, GVC.

Dick Huebner (Senior Managing Partner)

Jason, congratulations on a really good quarter and year. I have a question as it relates to the percent of revenues that stem from Medicare currently. Do you have information on that?

Jason Matuszewski (CEO)

Yeah. I mean, a majority of our revenue is predicated on Medicare reimbursement at this time.

Dick Huebner (Senior Managing Partner)

Okay. Jason, I've read that a couple of the approved items for treatment for lower extremity wounds currently are under $200. What is the cost per patient for treatment utilizing your products?

Jason Matuszewski (CEO)

Most of the prices that can be found in the marketplace are subject to ASP price reporting. Vendaje AC, as well as, both have published ASPs that you can go on CMS's website and find them.

Dick Huebner (Senior Managing Partner)

Okay. I find it interesting. My mother, four years ago, Medicare picked up the expense for 30 bariatric chamber treatments to heal a wound at the cost of about $75,000, where the infections were antibiotic-resistant and it was not being healed. I find it amazing that they would not look to expend several thousand dollars versus—that bariatric chamber ran 18 hours a day and was fully booked for nine months. I mean, it was a pretty amazing process to go through, but Medicare picked up all of the expense of that. It just seems to me, given cost-efficient alternatives, that they would not be willing to take more extreme measures than a couple of hundred dollar expenditures that seem to be working currently in the market or not working that well in the market.

Jason Matuszewski (CEO)

Yeah. I mean, I think it's an interesting point. Dr. Tudbeck actually just drafted—and you can look at online at Journal Wound Care—they did an analysis of actually what is the cost, especially in the skin substitute space, the cost to Medicare and the cost to the Medicare Trust Fund for the use of these products. It was actually a fascinating discovery that even moving these products up to where they are today from an ASP price reporting perspective actually saved the Medicare Trust Fund dollars. Why? Because ultimately, patients aren't having amputations. Patients aren't getting sepsis, which will drive a significant amount of cost to the system if these patients ultimately get brought back into the hospital system. Frankly, those wounds and amputations have to be treated.

There is a really bad statistic around the mortality rate of patients that ultimately end up losing a limb, and it's very high in a very short period of time. Hopefully, our goal is, with utilizing our BioREtain technology, that we have the ability to actually save those patients, save their limbs, and frankly, hopefully save their lives.

Dick Huebner (Senior Managing Partner)

I can't believe that the government wouldn't consider it because I don't think they give full consideration to anything. It seems like to me that they might give consideration to the fact that, hey, it does increase the mortality, and therefore, remove all those patients from being on Medicare to reshift that to the state and Medicaid costs because 90% of the people there live on average 15 months of their life there. Hey, you can shift the cost from Medicare to Medicaid if we continue with treatments that result in amputations and higher mortality rates. Anyway, that's a political commentary we don't need to get into. Thanks for your time.

Jason Matuszewski (CEO)

No problem. Thanks.

Operator (participant)

That was our final question for today. I'd like to hand the call back to Mr. Jason Matuszewski for any additional or closing remarks.

Jason Matuszewski (CEO)

All right. First and foremost, I want to thank everybody for joining the call. As we close out this call, I want to take a moment to reflect on how far we've come and where we're going. 2024 was a transformative year for BioStem Technologies, one defined by record financial performance, commercial execution, clinical progress, and strategic clarity. We launched new products, expanded our national footprint, advanced our trials, and brought forward a policy vision for the future of wound care. What excites me most about 2025 is the momentum we're carrying into it, with a clear strategy, a powerful platform in bioretain, and a passionate team committed to improving the lives of patients. We're focused on execution, advancing our clinical data, expanding payer access, launching new initiatives, and completing our uplisting to Nasdaq.

Above all, we remain committed to delivering value to our patients, our providers, and to you, our shareholders. Thank you for your continued trust and support, and we look forward to keeping you updated throughout the rest of this year. Thank you all.

Operator (participant)

Once again, ladies and gentlemen, that does conclude our conference. We would like to thank you all for your participation today. You may now disconnect.