BioStem Technologies, Inc. (BSEM)
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17th Annual LD Micro Main Event Conference

Oct 30, 2024

Jason Matuszewski
CEO, BioStem Technologies

Onto our product portfolio across the continuum of care. Our current outstanding is about 16.2 million shares. On a fully diluted basis, about just over 20 million shares, and currently listed on the OTC, but filed a Form 10 in September of this year, and looking to uplist to the NASDAQ in the near term, so let's talk a little bit about our technology and our product offering. Currently, we offer these four products. Our lead product, AmnioWrap2, is sold in the post-acute space, specifically for diabetic foot ulcers, pressure ulcers, and venous leg ulcers. Within the long-term care, skilled nursing, and mobile wound care segments, our secondary product that we just announced that we're launching yesterday is Vendaje AC. It's a play on words because Vendaje is actually Spanish for bandage.

Our next product is Vendaje, and the last product is Vendaje Optic, used as a protective covering in the orbital space. Our first two products are full-thickness grafts, meaning they are inclusive of the amnion, intermediate, and chorion layers of the placenta. And our Vendaje product is specifically around the use of an amnion or a single-layer product. To talk a little bit about the segments that we currently service in the post-acute space, we service hospital inpatient, private office, wound care clinics, mobile wound care facilities, home health, nursing facilities, and long-term and skilled nursing facilities. Our revenue is broken up into 33% in the podiatry space, 33% in mobile wound care, 21% in private office, and 9% in dermatology. All of these areas or sites of service are located in the post-acute space.

Now to talk a little bit more in depth about our unique processing methodology, BioRetain, something that we're really proud about, and our R&D and operations team have taken over several years to kind of develop and look at a unique way to process our products. One of the major attributes is the amount of anti-inflammatory cytokines that are retained in the graft, as well as the growth factor concentrations, and another element is the collagen-based structure. Typically, when we see other products on the marketplace, these collagen structures almost look like haystacks disassembled and disassociated with each other. Whereas within the BioRetain products, we have these nice long-strand collagen-based structures, which help support fibroblast migration down the collagen structures and support the wound healing process. In regards to our product and IP portfolio, we have a series of patents, both in use as well as structure.

A total of 70 patents, specifically 27 around placental tissue, 5 around our BioRetain process, and 37 around existing processing technology, Auxocell Technologies. There are global as well as U.S.-based patents. To talk a little bit about the process and how we actually recover tissue from centers throughout the United States, and then go about processing our tissue through the BioRetain process, so we initiate with multiple recovery partners throughout the United States. They work with prospective mothers, typically in the first or second trimester, about the gifted donation, and we honor that gifted donation once receiving that material. Within the successful planned cesarean section, we receive that material within 24 hours, and after that, in 48 hours, we process that material via our BioRetain process, and then ultimately, that material is shelf-stable and good for four years in a room temperature environment.

A long shelf life for the product. To date, we've recovered over 500, excuse me, 5,000 placentas and processed up to 100,000 allografts at this time. To talk about the regulatory pathway in regards to our products, typically devices are around the 510(k) de novo PMA route. If you're thinking about biologics or drugs, it's typically the 351 pathway. Our products fit in the middle of that, which is the 1271 361 pathway. Organ transplantation is similar in this pathway, where the products have to be used for homologous use. In our case, placental tissue is considered a covering or barrier in the womb. So when used in a wound environment, it serves as a cover or barrier for the wound bed. The products are processed via good tissue practices and regulated by the FDA for disease and transmission risks.

Also to highlight, the products are considered minimally manipulated, meaning there's not a lot of manipulation associated with the product. Now to talk about our facility and something I kind of highlighted earlier, we are one of 34 accredited facilities by the American Association of Tissue Banks, or AATB. We're in the process of actually expanding our manufacturing footprint from roughly 1,500 sq ft of ISO cleanroom space to 3,000 sq ft of ISO cleanroom space, and that should be online, hopefully by the end of this year. That allows us to move from our current manufacturing capacity of roughly 30,000 square centimeters a month to north of 100,000 square centimeters on a monthly basis. Like I mentioned earlier, our facility is located in South Florida in Pompano Beach. One funny fun fact is we're 18 ft above sea level.

It doesn't sound like a lot, but at least in South Florida, it means something. Now to talk a little bit about our commercialization partner, Venture Medical. Our goal as a manufacturer and identifier of existing products is to solely do that. We leverage our partner, our exclusive commercial partner, Venture Medical, for distribution and sales of all of our products. Venture has been instrumental in building out our commercial strategy over last year and into this year, and have done an amazing job of commercializing AmnioWrap2. Just recently, we announced that they will be sole exclusive distributor of our Vendaje AC product line as well to the post-acute space. Initially, we launched with them in AW2 and Q4 of last year and saw some really good success on the commercialization side.

Their footprint is over 150 representatives throughout the United States and are strongly positioned on the west coast of the United States, based in Missoula, Montana. We are looking to expand our footprint with their partnership into the east coast of the United States and targeting highly concentrated areas of Medicare beneficiaries. To talk a little bit about some of the clinical trial work that we are actually entering into, so we initiated two studies, one for our full-thickness product, which is amnion, intermediate, and chorion layers for DFUs. It's a multi-center site trial, 60 patients, 10 sites, and we're actively enrolling patients into this trial. We have actually an enrollment site just down the road here over at UCLA, and we're really proud of this trial.

I think it's going to show some really good results in regards to the use case of our product for treatment of DFU versus standard of care. And the second trial we're doing is a DFU study on our amnion-based product, similar structure where we're looking to have 10 to 14 sites with 60 patients. The primary outcome for both of these trials is complete closure at 12 weeks. And we're currently in process of setting up those sites and enrolling patients in that one. The third trial that we're actively working towards and standing up is a VLU or venous leg ulcer trial later this year, and hopefully working towards getting a data readout in Q2 of 2026. Why are we actually actively working towards these trials? Since I mentioned earlier that we're in the commercialization phase of our products.

The goal is to actually expand payer coverage for these products. So right now, our payer concentration is solely Medicare, and we're looking to expand into Medicaid as well as commercial payer coverage for these products, specifically GPO contract vehicles like Premier, Vizient and HPG. Now to talk about some of the retrospective data, and I think it yields to some of the results that hopefully we see in the RCTs. Just recently, we announced a retrospective paper that we looked at 50 patients treated with our AmnioWrap2 or Vendaje AC product versus a leading competitor product. And what we found in those Wagner 2, which is a more severe wound, that we have 27% more efficiency in treating these DFU in regards to the number of applications used to treat this wound against our competitors.

I think this is a testament to our BioRetain process in retaining all of those natural properties. I like to make a joke that you ultimately can build a sandwich in two ways. One is with Wonder Bread, where the bread serves as a function, excuse me, a structure that holds the sandwich together, but it serves no nutritional value. Or you can build that sandwich with organic natural bread, which ultimately supports not only a structure but also nutritional benefits, and we view our products as more of that organic natural bread that serves as a structure, but then eludes the natural elements within placental tissue to support the wound healing cascade process. Another retrospective study that we announced is our AmnioWrap2 and Vendaje AC comparison to standard of care.

This is something that's instrumental in really demonstrating our BioRetain process and why our BioRetain process is superior to other products on the marketplace. AW2 and VAC achieved almost a 10% higher expected wound closure rate compared to standard of care at 12 weeks. We hope to see that translation in our RCT as well. Secondly, for wounds that did not close, AWC and VAC resulted in a 93.6% improvement in expected percent area reduction over the standard of care, meaning we're getting these wounds closed very quickly at a rapid rate. Now to talk about the total market or addressable market, specifically in the wound healing segment. This is a massive problem. I think everyone here in this room identifies that currently we have 50 million Medicare beneficiaries to date, but by 2030, we'll have over 80 million Medicare beneficiaries.

Sadly, 20% of those folks have some sort of chronic wound, and actively today, we have over 7 million individuals here in the United States that have chronic non-healing wounds, and that is growing. To also talk a little bit more about specific indications or, excuse me, issues within the United States, there's a 13% increase in PAD from 2020 to 2030. A large portion of this market is roughly 43% specifically in pressure ulcers, 31% in diabetic foot ulcers, 12% in venous leg ulcers. Those are areas in which we're looking to treat with our products. In regards to the market for the chronic wound market, it's about $1.1 billion as of 2022, growing at an exponential CAGR of north of 12%. Now to talk a little bit about the financial performance of our organization over the last few quarters and some of our strategic growth initiatives.

As you can tell, we've been on a tear, like I mentioned earlier, in regards to commercialization of our product lines. We've had an amazing back half of 2023, specifically Q4, of $11.5 million in revenue generation. And 2024, we're on our way to a very successful year. To dive a little bit deeper into Q1 and Q2 numbers, so Q1, $41.9 million in revenue, Q2, $74.5 million in revenue, Q1 net income of $4.4 million, Q2 of $6.3 million. For the first half of the year, it's $9.6 million in net revenue. That's on a non-adjusted EBITDA basis as well. So very successful year so far and really excited to kind of see where things go going forward. Sorry, one thing to also mention is our cash position.

As of the end of last year or, excuse me, at the end of Q2, we had about $6.5 million in cash currently on the balance sheet. Now to talk about some of the strategic initiatives and for our mission to sustain this type of growth, as well as look at product diversification and risk mitigation, so we're going to continue to expand our product portfolio and look at, like I mentioned earlier, GPO and IDN contracts for the specific acute space. We're going to continue to expand our product portfolio right now, obviously focusing on AmnioWrap2 or AW2, but then the launch of Vendaje AC will help support into the post-acute space. All of these products will continue to have very strong margins.

Second to that, continue to strengthen our reimbursement strategy, broadening our path specifically into the GPO side of things, as well as commercial payers based on hopefully our solid clinical results later next year, and then looking at M&A targets going forward into the back half of this year, as well as into next year, to build out a portfolio of products for our commercial engine team, Venture Medical, across the continuum of care. Our current products serve almost like the last book of the bookend of the bookshelf, meaning we have product that is a product of last resort. A patient has to not respond to standard of care for over 30 days, and then they're able to actually utilize our product as advanced skin substitute.

We're looking at products that ultimately service that patient upstream in the diagnostic space, energy debridement space, collagen or synthetic-based products, things of that nature, biofilm busting products, to really build out a portfolio of products that ultimately build a stickier relationship for Venture's customers. Now let's talk a little bit about our capital market strategy. As I mentioned earlier, we filed our Form 10 in September of 2027. We're actively working with the SEC to get comments back on that Form 10 and then also submitted our NASDAQ application. Hopefully, in imminent fashion, we'll see an uplisting here before the end of the year. To talk a little bit about the management team, like I mentioned, and thank you for the introduction earlier, my name is Jason Matuszewski. Matuszewski? Matuszewski. I am the Co-founder and CEO.

My co-founding partner, Andrew Van Vurst, is the COO and oversees all of our operations and manufacturing. Mike Fortunato is our CFO, who has really strong experience working as head of technical accounting at Facebook and was instrumental in the Upwork IPO. Also served as an enforcement agent for eight years in the Bay Area here for the SEC. So great experience in the public markets. Our Chief Commercial Officer, Shawn McCarrey, helped and was instrumental in the AxoGen commercialization of their products and built that team from sub-10 individuals to north of 80 individuals and a revenue run rate of 10 million to over 100 million in revenue. And last but not least, our VP of R&D, Dr. Wendy Weston, who came over from University of Miami Tissue Bank, who has been instrumental in developing and patenting the BioRetain process.

Now to talk a little bit about our board of directors. Most recently, I've moved down as the chairman of the board and brought in Tom Dugan as the chair of the board. He served as vice president of the wound care division at Smith & Nephew for a very long time, as well as becoming the CEO of Amniox or BioTissue, and then subsequently the CEO of Integrum. Tom has an instrumental experience and a long history in wound care, helping Smith & Nephew develop their PICO or negative pressure program, as well as other programs within Smith & Nephew, helping support wound care. Brandon Poe, who is our audit chair, who is currently the CFO at Medsphere and served as the CFO at Illumina.

Pat Daly, who is our Compensation Chair, who was a longtime member at J&J and served as the CEO of Cohera, as well as currently serving as the global vice president at IQVIA, a large medtech data company. And last but not least, my co-founding partner and our PhD scientist, Dr. Ken Warrington, who was one of the co-founding partners at Lacerta Therapeutics. So where are we going from here? As I mentioned earlier, we have some of the very superior products specifically around the BioRetain process. We feel strongly that these products are differentiated compared to our peers in the space, and we're going to be a leader in this space in regards to perinatal or placental-based tissues. We'll continue to focus on developing and building out a robust clinical data set for our products, specifically our two RCTs. We're working towards expanding payer coverage.

Obviously, with the RCT data, we'll help support GPO contracting vehicles, but then also looking at adding more retrospective data to our products as we continue to treat patients with our products, and we're committed to revenue growth and profitability via our existing organic commercialization of our products, but then also looking at M&A targets along the way to expand our continuum of care products, and with that, I open it up to any questions.

Can you comment on the revenues to spike from second half last year to the first half of this year?

Yeah. I think the biggest driver or catalyst to that is obviously working with Venture Medical. Venture Medical, when we struck that deal, they already had 150-plus individuals on the ground.

And for them to accelerate and commercialize this product was initially a flip of their existing customer base to our product, and then subsequently expanding that coverage from only those three max to then now seven max at the start of this year helped allow them to have more access for their folks to convert existing customers and then expand into new customer base.

And then is that deal exclusive with Venture Medical too? Where do you think the penetration is with Venture into the market? Yeah. And what's the ceiling on that? Yeah.

I think right now, to answer your question, yes, it is exclusive with us, specifically placental tissue products. It's the exclusive product that they commercialize today. I think right now we're sub-20% penetration in the post-acute space with them. I think there's still a lot of room to grow in the post-acute space.

I think also too, some of the initiatives that we'll be taking at the end of this year and into next year is really targeting the acute space into the hospital system with these products, either on regional purchasing coalition agreements or RPCs, as well as IDN or local agreements within hospital systems. So I think there's a lot of opportunity not only in the post-acute space but also in the acute space.

No problem. Medicare reimbursement, right? Are you seeing pressure on that? Are you going to go up?

Yeah. So at least in the so there's kind of two silos to Medicare reimbursement for these skin substitute products. One is in the post-acute space, the model's ASP+6. This has been implemented due to the Inflation Reduction Act that started in January of 2022.

So at least in the post-acute space, we report our ASP data on a quarterly basis and kind of continue to report that. I think one of the unique aspects is we leverage a bona fide services model with Venture Medical. So we sell product to them at a WAC transfer price, and then they ultimately charge us a bona fide service that meets a four-prong test. Those services met a fair market value as well as to coming up with that percentage. And it ultimately stabilizes our pricing. So we continue to sell at that WAC to them consistently quarter over quarter. I think one that supports us helping to continue to commercialize the product at a standard price, but also allows us to collect data from a retrospective or real-world data perspective. So right now, I don't think we see any sort of compression on the pricing.

I think as we kind of roll forward, I think at some point, because of the pricing structure, Medicare may see a way to restructure this thought, at least for these products, similar to what you saw maybe with some of these bigger branded-based drugs that Medicare put pressure on. Or I should say CMS put pressure on. Go ahead.

Can you share how you think about your accounts receivable balance and maybe some of the terms you extend to your customers?

Yeah. So technically, we really only have one customer, i.e., Venture Medical. So it's siloed in that respect. Venture's terms are 90 days. So we have continued to kind of a very continuous relationship in regards to receiving those receivables. Obviously, as sales grow, receivables grow up. The concept around 90 days is really around the fact that the reimbursement cycle is typically 45 days.

For them to ultimately get products sold into the physician and then that physician getting reimbursed and then ultimately they get paid for their invoices, that's kind of the compound of why we got to 90 days. We do ship product on a daily basis to Venture Medical. So there is no sort of stuffing a channel in this situation where we're actually continuously shipping product on a daily basis, almost like a just-in-time type delivery. That's it. Thank you so much. Thank you.

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