Vericel Corporation (VCEL) Earnings Call Transcript & Summary

[Audio Gap] Bank of America. Today, I'm here to introduce Vericel, a leading provider of advanced therapies for the sports medicine and severe burn care markets. Please welcome to the stage Nick Colangelo, Vericel's Chief Executive Officer; and Joe Mara, Chief Financial Officer.

Thanks, Gracia. It's great to be here. And before I begin, I just want to remind folks that this presentation contains forward-looking statements, so you should refer to our documents on file with the SEC for further information. As Gracia mentioned, Vericel is a leader in advanced therapies for the sports medicine and the severe burn care market. We have a highly innovative portfolio of specialty biologics and advanced cell therapies that repair tissue and restore function. Our lead product is MACI, which is a cell therapy product that uses the patient's own cells to repair damaged cartilage tissue, which we launched in 2017 for the repair of cartilage defects of the knee. And it's become the leading restorative cartilage repair product on the market and the only FDA-approved product approved in its class. So we recently received FDA approval for MACI Arthro, which we believe will drive greater penetration into our addressable patient market. On the burn care side, we're focused on hospitalized burn patients, severe burn patients. And for those patients, the treatment pathway basically entails removing the burn tissue or the eschar and then grafting the wound to promote healing. And we actually have products that cover both aspects of the treatment pathway. NexoBrid is an orphan biologic product in the U.S. that we launched a little over a year ago that's indicated for the removal of eschar. And Epicel is the only FDA-approved permanent skin replacement for large full-thickness burns. And so having products that address both aspects of the treatment pathway, we believe positions us to have the premier portfolio in this space. And our portfolio is very unique and that we have significant barriers to entry. MACI and Epicel are regulated as combination device biologic products in the U.S. And so there's really no generic pathway for other products to enter the market, and there's no near-term like competitors either on the market now or in development. So we think we have a great position there. And then again, NexoBrid is an orphan biologic, so it has orphan exclusivities, biologic data exclusivities. And so we think it's an exceptional portfolio to continue to drive sustained growth as we move forward. And we think the company is very well positioned to do so. So it starts with our financial position. So as I'll talk about in a moment, we've generated several years of high revenue growth and we continue to do so, significant profit growth as we've delivered positive adjusted EBITDA and operating cash flow each year. We were GAAP positive, net income positive last year, and have a very strong balance sheet with over $160 million in cash and no debt. So we're very well positioned from a financial perspective. We've developed one of the premier sports medicine businesses and obviously are a leader in cartilage repair, and we expect to be able to enhance and reinforce our leadership position there with the launch of MACI Arthro. We've developed the burn care business into a second high-growth franchise. The burn care franchise grew 22% last year. So we're excited about having both NexoBrid and Epicel as we move forward. And then we continue to expand our core portfolio. So we expect to initiate a MACI ankle study for the treatment of cartilage defects in the ankle. And we just completed our new manufacturing facility and world headquarters in Burlington, Massachusetts, which will allow us to potentially launch MACI outside the United States in the years to come. So we think there's a great growth pathway for the company as we continue to move forward. We operate in large, underserved markets that we think will support the growth. The current TAM for our core portfolio is about $4 billion. And with the potential addition of the MACI ankle indication, it would bring that to over $5 billion. So clearly significant markets to support our expected near-term and long-term growth. And we do have a strong track record of revenue growth as I mentioned, since we launched MACI in 2017. Our compounded annual revenue growth rate is about 20%. Last 2 years, was 20% growth. And we expect 20% to 23% growth this year based on the momentum of our core portfolio, the launch of MACI Arthro and then continued uptake for NexoBrid. And then as we look in the out years, again, the potential launch outside the U.S. of MACI and then MACI Ankle indication that we think we're well positioned for continued growth in the years ahead. In addition to our strong revenue growth, we've now had two straight years in 2023 and 2024 where we've had 20% top-line revenue growth and more than double our adjusted EBITDA or profit growth. And so with 58% adjusted EBITDA profit growth last year. And as I mentioned, we're a GAAP net income positive as well. And we're actually at a point now where our cash generation is reaching an inflection point. So we invested nearly $100 million in our new facility over the past few years. Our cash balance actually grew during that time. And with most of that CapEx behind us now, starting in the second quarter, we expect to generate significant cash going forward. So really excited about the outlook company as we move forward. So I'll start with MACI in the cartilage repair market. Cartilage injuries are a significant issue because -- and their costs, it's essentially a pothole on the surface of the knee caused by acute or repetitive injuries and the issues that cartilage, unlike most tissues in your body does not have intrinsic healing properties. So if you have a cartilage injury, it basically puts you on a path to, obviously, chronic knee pain and loss of function, but also osteoarthritis and ultimately, partial and full knee replacement. So it's a very significant issue, a very large commercial opportunity for us. There's about 750,000 knee cartilage repair procedures each year. And without going through all the details, for us, there's about 60,000 patients in our addressable market and our current revenue per implant of around $60,000 per implant, it results in a greater than $3 billion addressable market for us which clearly has been supporting the growth that we've seen. The product itself is composed of taking a patient's cartilage cells or chondrocytes, seeding them onto a resorbable collagen membrane that is surgically implanted. So we take a biopsy, it's sent to us. We process it. We expand the cells. We cryopreserve them until a surgeon and a patient are ready to move forward with surgery. We thaw the cells, further expand them. They're seeded at about 0.5 million to 1 million cells per square centimeter, shipped to the surgeon at this hospital or ASC. When they implant the membrane, basically the chondrocytes which are spindle cells, they hold on to the collagen fibers, they migrate down to the subchondral bone and then start to replicate, produce extracellular matrix and ultimately fill that pothole on the knee with cartilage. So very innovative product. The reason MACI has become the leading product on the market is that, first of all, it was approved by under a BLA by the FDA. It's got a very broad label, unsurpassed clinical data. So addresses a good number of the patients in that overall addressable market. It's a vastly superior, much less invasive, simpler, faster surgical procedure, and that's what's broadened out the surgeon base that uses MACI. Rehab protocols are much shorter because it's a less invasive surgery, and it's got terrific reimbursement coverage, all the major plans in the country cover MACI under their medical policies. So we expect those attributes to continue to grow or support the growth of the core business, but really MACI Arthro or the arthroscopic delivery of MACI represents another significant procedural advancement that really targets the largest portion of our addressable market, which I'll cover in a moment and really just accelerates or continues down our path of trying to make these cartilage repair procedures with MACI simpler and less invasive which is kind of a common playbook in the med tech industry. So when you look at our overall -- this is a busy slide, but if you look at our overall addressable market of those 60,000 patients on the left-hand side, the two columns represent sort of where MACI prior to the Arthro launch was kind of a go-to product. So in the patella or at the back of the knee cap when you have a cartilage injury, it's really hard to use other treatments in that area. So we have double-digit penetration into the patella market, which is about 10,000 patients a year. Also, if you have large defects greater than 4 square centimeters, which is really a large pothole on the surface of the knee, that's where MACI has double-digit penetration as well. Again, the MACI Arthro instruments are designed to treat 2 to 4 square centimeter defects on the femoral condyle. So that's the most common area as you'd expect, that bears the most forces and weight from the knee. So you have a lot of injuries there and it represents about 20,000 patients a year or 1/3 of the addressable market. And again, the instruments are designed for either a 2, a 3 or 4 square centimeter defect, it really simplifies and we think that we've had single-digit penetration in that part of the market, and we think MACI Arthro will allow us to get much greater penetration into that market. And finally, the last 20,000 patients of the 60,000 patient TAM are really just other small defects throughout the knee, which I'll talk about in a minute as well. So when we look at the progress of MACI Arthro launch, which really began in earnest this year, as we talked about on our earnings call last week, we've trained over 400 surgeons to date, so that pace is actually ahead of our plan and ahead of the number of surgeons we had trained at a similar point in time following the original MACI launch. So really encouraged by that. But what we're seeing with the behaviors of those surgeons is even more encouraging in terms of the early leading indicators. So we see that biopsy growth rate for MACI Arthro trained surgeons year-to-date versus last year, is up over 30%. So significantly greater than the overall biopsy growth rate. And then we see within certain segments of those surgeons, for instance surgeons who maybe only thought about MACI for patella or back in the knee cap injury is actually taking biopsies, growing at a higher rate, but taking biopsies for other parts of the knee, which is great because they're thinking about more patients for MACI. And then we've seen a significant number of the MACI Arthro cases that are done are actually outside of the femoral condyle. So surgeons are thinking about using or are actually using MACI Arthro in other parts of the knee, in particular, the trochlea which is behind the knee cap and it's a difficult place to do procedures. And so we're encouraged that surgeons are kind of thinking about a broader application from MACI Arthro and we think that's going to drive continued growth for us. So turning to our burn care franchise. First of all, as I mentioned, when you had these hospitalized burn patients, the first part of the treatment pathway is to remove the burn tissue so that you reduce the possibility of infections, sepsis, burn progression because your body has an inflammatory response. So you need to get rid of that dead tissue. So very important to do so. So right now, surgical excision is the standard of care. So into the OR, take a knife, slice away the dead tissue until you get to healthy tissue, which you can tell when you start to see blood, et cetera. So there's a lot of healthy tissue with blood loss, so very traumatic for the patient. There are some non-surgical treatments that are recognized as being less efficacious. So there's clearly an unmet need for an effective and selective debridement agent for -- or eschar removal agent for this eschar. And that's where NexoBrid comes in. So NexoBrid is a product that we think is going to change the standard of care for these patients. So it's a mixture of proteolytic enzymes that are topically applied and these enzymes recognize collagen proteins in the skin that are denatured by thermal burns, and they're able to dissolve away that tissue but leave the healthy tissue. So much better for the patient. It's applied outside of the OR. And really, again, we think will change the standard of care over time. We've seen good adoption in terms of the number. There's 140 burn centers in the country. We were targeting the top 90 when we launched NexoBrid a little over a year ago, currently have 60 ordering centers, so making good progress in adoption of NexoBrid. And then as I mentioned, once you remove the eschar, you need to figure out how you're going to cover the wound. Skin is highly immunogenic, you can't -- it's the largest organ in the body, but you can't do an organ transplant of someone else's skin, the body will just sluff it off. So you either have to do autografts of a patient's own skin which is difficult when you have these large burns. So we're routinely treating patients who have 60%, 70%, 80% of their body surface area burn. So there's not a lot of healthy skin to do autograft. So we take a small biopsy of the skin, just like with MACI, we expand the keratinocytes. We create these grafts that are applied to the patient and promote healing. And as I mentioned, it's the only FDA-approved permanent skin replacement. And the chart on the right just shows there's a profound survival benefit for patients who are treated with Epicel at every decile of burn compared to the standard of care. So really excited about the burn care franchise. As I said, turned it into a second high-growth franchise. Our goal now is we've expanded our commercial footprint. The entire sales force to selling both products, focused on NexoBrid uptake, having all the centers who are using NexoBrid become consistent users and then broadening out the Epicel utilization as we're in more hospitals. So last slide in my last 7 seconds is that while we've got a great portfolio really provides a long pathway for growth for us. We're also continuing -- we built the company on business development deals. We acquired MACI, Epicel from Sanofi about a decade ago. We licensed in NexoBrid and we continue to look for products in the sports medicine or the burn care markets or other adjacencies that leverage our cell therapy manufacturing and development skills. So with that, we are out of time, and I thank you for attending.