Covalon Technologies Ltd.

Good morning, ladies and gentlemen, and welcome to Covalent's fourth quarter fiscal 2025 conference call and webcast. My name is Constantine, and I will be your conference operator today. As a reminder, today's conference is being recorded. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question and answer session. If you would like to ask a question during this time, you can submit your type question via the webcast. Alternatively, if you would like to ask a question over the telephone, simply press star then the number one on your telephone keypad. If you would like to withdraw your question, please press star then the number two. If at any time during this call you require immediate assistance, please press star zero for the operator. At this time, I would like to turn the conference over to Mr. Brent Ashton, Chief Executive Officer. Please go ahead.

Hey, thanks, Constantine, and good morning to all of you on the call today. We really appreciate you connecting in. I'm joined here with Kim Crooks, our chief operating officer, and Katie Martinovich, our chief financial officer, as well as Saleha Asadzada from Kobalon, who's helping to coordinate the conference call and the webcast today. Saleha will now provide us with some instructions.

Thank you, Brent. Good morning, everyone. My name is Salia Sadzada, and I am the Executive Assistant to Kovalan's Chief Executive Officer. I'd like to thank everyone for taking the time this morning to attend our conference call. Before we begin the discussion, I would like to remind participants that this call and webcast are covered by Kovalan's Safe Harbour Statement. Please read the Safe Harbour Statement on this slide. This is also available on our website. I will now turn the call back over to Brent Ashton, Koblan's Chief Executive Officer.

Thanks, Saleha. Glad to be able to be with you all today. And really, thanks so much to everyone on the call for taking time out of your busy end of calendar year schedules to be with us today, this morning. Before I begin, I'm very pleased to be able to share that yesterday afternoon, Kovalon's board voted to approve the appointment of Katie Martinovich as chief financial officer and remove the interim designation from her title. This decision reflects the board's acknowledgement of Katie's loyal and dedicated contributions in leading the company's financial management and her contributions during her tenure as interim CFO. So congratulations to Katie. I'm looking forward to sharing the results and progress that we're making as we advance forward with our growth journey here at Kovalon. During today's call, we'll cover the following topics. First, I'm going to start with sharing some thoughts by Nancy Moreau, a rockstar key opinion leader in the vascular access world. Second, I'm going to share some notable recent accomplishments and outcomes from Kovalon that have us really excited for our future as a company. Third, I'll dive in on our financials. We'll walk through our Success in closing out our fiscal year 2025 with our highest quarter of revenue for the year, as well as looking deeper at Q4, the full fiscal year, and as we've done for the past year and a half or so, we'll also showcase some key metrics from our U.S. vascular access and surgical consumable sales channel. Fourth, we'll go a little bit deeper into our operational optimization work that we've been driving over the past year and a bit. And then we'll wrap up to take questions from the audience. Just one note, the web interface questions will be prioritized first. So as we go through the next 20 to 30 minutes or so, please make sure you enter any questions you might have there so that we can answer them. Excuse me. Last quarter, I shared the story of Jaden, a young woman with significant medical challenges and the role that Covalon's amazing IV clear technology has made to her quality of life. This quarter will pivot from the patient side to more around the clinician side. Dr. Nancy Moreau is a literal force of nature. In my more than 10 years operating in the vascular access space, I'm really hard-pressed to think of anyone who is more respected by more practicing clinicians than Nancy. She's someone whose guidance shapes clinical standards, influences clinical decisions, and as an amazing educator, there are literally tens of thousands of nurses who advance their clinical skills to improve patient outcomes based on interactions with her in one form or the other. Kovalon has been working closely with Dr. Moreau, and we're looking forward to seeing her on the podium next year at major scientific meetings, such as the Infusion Nurses Society annual meeting, where she'll be discussing the clinical challenges that Kovalon is working hard to help clinicians all over the world address. Her message here that you can see on the screen is clear. Despite years of effort and innovation, Catherine associated bloodstream infections remain a major source of preventable patient harm with significant outcome implications for patients and high cost impacts on health systems. Despite a lot of progress through both products and practice existing prevention bundles are just not enough. There is still a critical gap, one that stems from the persistent contamination of IV lines across all care settings. And that's exactly where Valguard, our product, Covalent's product, delivers meaningful value. As Dr. Moreau states, Valguard provides the missing layer of protection that most current infection prevention bundles lack. The recent study from Montefiore that showed a significant reduction in CLABSI rates proves the impact that this technology can have on patient outcomes and hospital performance. You may be asking, hey, like, why should this matter to investors? Well, because independent validation from someone of Dr. Moreau's stature helps to accelerate trust and adoption of innovative medical technologies like Valgard, nurses and infection preventionists often look for credible third-party clinical leaders to help support new technologies before they adopt and scale usage. With this kind of expert advocacy from Dr. Moreau and others, growing clinical evidence, and exciting future sales and marketing plans, we see a clear pathway to a significant expansion for Valgard. With the comments from Nancy and her perspective on Valgard, it's a good segue into some exciting highlights since our last earnings call back in August. Last quarter, we shared the pending publication of the Valgard Bloodstream Infection Study that was led by the Children's Hospital at Montefiore in New York City. This peer-reviewed study did indeed publish in mid-September in the fall edition of the Journal of the Association for Vascular Access, and the study authors presented the results to a packed room at the Association for Vascular Access annual meeting in late September. With this evidence in hand, Covalent has had a ton of new conversations and touch points with hundreds of customers, and the sales opportunity pipeline is very strong. Just look at the key highlights from the authors. A significant decrease in CLABSI rates. PCCU, that's the Pediatric Critical Care Unit, CLABSI-free. These are huge outcomes. I wish I could take you, each of you, into the PCCU at Montefiore or other hospitals where our product is used. And you can look at around all these precious babies and kids and in adult facilities, adults. A lot of them are going through some really rough and really complex medical issues. And if not for Valgaard, some of them would develop a bloodstream infection and have an even longer stay in the hospital for some. And for some others, they just wouldn't make it. An unimaginable outcome for a parent, for a spouse, for a child, and the absolute toughest conversation for a nurse or a doctor to have with family members, your child, your spouse, your mother, your father, they didn't make it. I'm and the team are extremely proud at Kovalon that we're helping our clinician partners protect their precious patients. And then switching gears and switching products, also very proud to be able to share that we recently secured a new strategic partner on our U.S. advanced room care business, our collagen business. We're excited for the growth prospects of this new partner and have secured a first purchase order for more than a million dollars that will ship once we receive packaging in our second quarter of 2026. Of course, we were also very excited to be able to issue the special dividend of 15 cents per share, which paid out a few weeks ago. We've heard from a number of shareholders who used the proceeds from the dividend payment to purchase additional shares of Covalent, which we appreciate. The special dividend payment, which was the first ever in our company's history, is a solid reflection of the strong financial performance and continued success that we've had. Following the $4.1 million dividend payment in mid-November, I'm happy to report that as of the end of last week, we had $17 million Canadian in cash, which compares to $16.7 million from a little more than a year ago at the end of our fiscal 2024 on September 30th, 2024. So solid cash generation by the company. And on the quality front, very pleased, but not at all surprised that we recently completed an onsite ISO 13485 surveillance audit with no non-conformances. Kim, Theresa, and our entire Covalent team have made a lot of progress on the operational and quality front over the past year or two, and it's great to see this show up in things like this audit. And then flipping back to the product front, last quarter we did a bit of a deep dive into an exciting new indication that we obtained on our CovaClear IV product. This is the mud flap application, essentially an indication for using the dressing as a secondary barrier protection device to protect the primary IV dressing from contamination. Well, this new indication is really starting to gain traction. Happy to report that a major children's hospital in the Midwest first learned about this novel use of our product earlier this year and started a trial on one single unit over the hospital. Thanks to the great work of our Covalent team working with the hospital, combined with an incredibly strong outcome from the trial, The hospital chose to adopt this product for use on 11 different units within the facility. What we term as a house wide adoption. All told we expect this 1 account to drive more than 50,000 dollars in incremental revenue with this new indication. Our sales funnel for this product is growing exponentially and we see a bright future for the use case. And then a good wrap up here to a really successful fall season for our scientific meeting engagement and participation. Across the three important meetings that we participated in over the past few months, Kovalon was on the podium at a major meeting for the first time in our company's history at the Association for Vascular Access when the Montefiore study authors presented the results from their ValGuard study. We had really strong engagement in the booth and managed to generate more than 700 customer leads across all three events, which was almost 30% higher than last year with the same meetings. Our sales and marketing teams are conducting strong follow-up to these leads to bring them to revenue fruition. So with that as a backdrop, moving to the financial side, first we'll look at Q4. Revenue came in at $8.7 million. This was our highest revenue quarter of fiscal year 2025 and essentially flat Q4 a year ago. Strong growth in both U.S. vascular access and surgical, as well as our international sales channel, was offset by declines in our U.S. advanced wound care sales channel. Gross margins were down compared to a year ago, largely driven by product and geographical mix. On the product side, it was a shifting of skew mix within our U.S. advanced wound care sales channel. And on the geographic front, our international revenue was about 15% of our total revenue, but more than double what it was a year ago. But the international business does carry a lower margin profile than the US. Operating expenses were down about 10% versus last year's Q4. And we had a drop in our adjusted EBITDA, almost entirely a function of our gross margin change from a year ago. Looking at the full fiscal year, revenue came in at 32.8 million, which was up 5% from fiscal year 2024. Similar story to Q4, strong growth in both U.S. vascular access and surgical, as well as international. Both grew more than 40% on the year, but that was offset by single digit percentage declines in our U.S. advanced wound care business. Gross margin at just over 53% was impacted by three things. The product and geographical mix shifts that I spoke to for Q4, as well as inventory write-offs that we spoke about last quarter. If you exclude the inventory write-off expense in FY25, our gross margin for the year was 56%. Operating expenses were down 6.4% from FY24, and in fact, down more than $3 million from our FY23 levels, so a strong continuation of our disciplined spending and solid operational execution. Adjusted EBITDA and EPS were both down due to the margin shift, partially offset by the reduced spending. So now looking at the US vascular access and surgical consumable sales channel a little more closely, we continue to be a strong partner to the top children's hospitals in the United States. Looking at the metrics that we believe are important key performance indicators for this channel, as we look at our top 50 US hospital customers from last year, in terms of retention of these important customers that we've worked hard to acquire and grow in the past, we've maintained 100% success in retaining all 50 of these customers throughout the full 2025 fiscal year. Our second priority is around growing our existing accounts, either by adding new products or new product use cases, or by growing the volume of existing products in the account. And here we've seen solid total revenue growth of 25% in the full fiscal year from the same group of our top 50 customers, top 50 hospital customers from last year. And then last but not least is adding new customers where for the year, we've added 74 new hospital customers While we're certainly proud of this growth and acceleration, we've really only scratched the surface in terms of what we can be here. And then transitioning to wrap up the presentation. A year ago, I shared these four areas of focus for 2025. And each quarter, we've done a double click on one of the four. As a company, we're really proud of the progress and advancements that we've made in each area. And today, we'll go a little deeper on the operational optimization front. The operations front has been a huge area of progress for Covalent in the past two years. Started with bringing Kim Crooks back to lead this area, and she's done a great job strengthening our team and doing work in this area. And it was a well-deserved promotion earlier in 2025 to be our chief operating officer and join our board of directors a few months ago. Over the past year, Covalent has taken important steps to strengthen the operational backbone of our company. Our work is focused on four core priorities that are transforming how we manufacture, how we manage quality, and how we scale for the future. Going to the next slide. First, we are accelerating automation and digital enablement. We've introduced real-time dashboards, automated batch release workflows, and a new EQMS, or electronic quality management system. In the new year, we'll be introducing new manufacturing modules within our ERP system. These tools give our teams better visibility, faster decision-making, and tighter control over materials, scheduling, and quality. By adopting collaborative digital platforms, we're breaking down silos, enabling a more connected data-driven operation. Second, we're streamlining processes to drive cost efficiency. Through value stream mapping and updated SOPs, we removed unnecessary steps and cleared bottlenecks that slowed production. More rigorous planning based on demand, order, flow, and run rates has reduced waste and shortened changeover times. Third, we're embedding a culture of continuous improvement. We strengthened our use of root cause analysis, expanded mistake proofing, and reduced scrap and rework by addressing the core drivers of variability. Weekly operational huddles and structured quality reviews have sharpened our focus on accountability and responsiveness. This culture shift ensures that operational excellence isn't just an initiative, it's how we run the business every day. And finally, we're elevating capability through talent development. Cross-training our teams has significantly increased flexibility across the organization. We're aligning staffing with workload patterns to maximize utilization, and we're upskilling employees to support more advanced equipment, processes, and digital tools. Building this capability is essential to sustaining our progress and unlocking further productivity gains. Together, these actions are transforming Covalent into a more efficient, more agile, and more scalable company, one with the operational strength to support our growth and deliver exceptional outcomes for clinicians and the patients who rely on us. So to wrap up today's call so that we can then take some questions, a quick summary. We're making a significant impact on saving and improving patients' lives. And we are an important partner to the thousands of amazing clinicians who rely on our product every day to do their amazing work. Our visibility is rapidly increasing. You see that through the work with Dr. Moreau and evidence publications. And when you talk to companies and customers throughout the spaces that we play in. The recent dividend that we paid out was a really important milestone in our company's history, and it's a strong reflection of where we've gotten to of late and the belief we have in our future. And last but not least, the areas that we're focusing on and investing in are driving really strong outcomes to benefit today and even more so in the future. And so with that, we'll transition to Q&A. For our questions, we'll start with questions that are typed into the Q&A feature here online. We'll take about a 30-second pause to get things in order. and then answer your questions. Okay, our first question comes from Arnold Shell. Good morning, Arnold. And the question is, you know, top 50 hospital customers grew 25%, 74 new hospital customers were added, and total revenue growth for the year was only 5.3%. So his question is around, you know, what's shrinking and why? And so as I explained earlier, that offset was around our U.S. advanced wound care sales channel. And as we've talked about this past year, on the heels of some incredibly strong growth last year, where we almost doubled the revenue, some inventory build in the channel in 2024 impacted our growth this year and led to that single digit decline. So that is that question. Arnold also has another question. Without the dividend payment, cash would have been up $3.5 million. How is this cash being generated? And will this level of cash generation continue in future quarters? Yeah, we're really proud of the work we've done over the last couple of years. Over the last two years, our cash flow from operations has totaled over $5 million. And that's after several years of burning through cash. And so the cash is being generated through strong combination of strong growth on many of our products, operational efficiencies that Kim and the team have been able to drive and a really strong outcome for the company. As for the future, obviously we're very bullish on our future as a company and the ability to continue to generate cash. Our next question comes from Zach. I'm not sure I'll pronounce this correctly. Apologies if incorrect. What are your expectations for gross margins in 2026 relative to 2025? And, you know, I would say on the gross margin front, you know, we closed the year X the inventory issue at around 56%. And really, you know, see gross margins right in that sweet spot for med tech companies in the low 50s to high 50s, some maybe into the low 60s. I will tell you, you know, at the 56% for the year, we're well above the gross margins of many of our larger competitors that have, you know, scale and volume that we're driving towards, but not there yet. Good morning. So Matthew Martin has a question as well. Good morning, Matthew. What are your expectations for the new wound care strategic partner? And so, yeah, we did receive a purchase order, a first purchase order for more than $1 million. And so we're working with them to see how we can take that, expand upon that and go from there. Excited about the opportunity to work with them. I think it's off to a good start and we'll advance from there. So Zach has another question, which is, what would you say has been the primary driver of slowing growth in revenue this year? And do you expect that to change this year? Yeah, as I said, you know, that the, you know, 40% plus growth in both vascular access and surgical consumables in the US, as well as in international. And so that slowing growth in revenue was on the US advanced wound care side, largely driven by that inventory challenge, as well as a disruption related to an ownership transition of a strategic partner there. Do we expect that to change this year? Yeah, I mean, as we continue to advance our US advanced wound care sales channel. We're always driving to maximize revenue there and we'll advance quarter on quarter as we go. Kind of a related question from Matthew. Can you provide more color on the disruption related to an ownership transition of the U.S. Advanced Wound Care strategic partner? Is this impact expected to persist in subsequent quarters? And so, yeah, so unfortunately these things sometimes happen to your customers. One of our strategic partners on the U.S. Advanced Wound Care side went through some challenges and had an ownership transition. Not the first company to go through financial challenge and won't be the last. I tell you, though, it does make me really glad at Kovalon that we built a very strong financial foundation sitting on $17 million of cash and no debt, seven straight profitable quarters. But yeah, no, the impact is not expected to persist long term. We did in the quarter here pick up business with the new owners. And I'd say that's off to a very good start. But there is a little bit of disruption here in the short term. And then there's some questions from Arnold and Jeff Shell around growth and 2025 growth versus outstanding growth. You know, I guess I would answer these questions by saying, you know, we've got three sales channels that we focus on. Our U.S. vascular access and surgical consumables, lots of solid progress this year, 40% growth in 25. That's eight to 10 times the market growth rate. And it was even higher than that in Q4. The sales channel where we control the most directly, and I think we've had sequential quarterly growth in eight of the last nine quarters. The international business also more than 40% growth for the year and almost double the revenue in the quarter versus the prior year. And then there's the US advanced room care business. So coming off a year last year where that sales channel had a massive growth of about 70%, inherent was the meaningful growth in channel inventory, logical when you have that kind of growth. So a tough call. As we look forward, we're doing everything we can to drive our growth. It's key. We have alignment on the board of the biggest area of focus is obviously to drive the growth, drive sales and marketing, expand our customer touch points and partners on the U.S. side. And so that's the growth we're doing. Is the journey going to be completely linear? Absolutely not. I think I've said that quite often. You know, we're not a Costco or McDonald's with, you know, tiny single digit increases in revenue every quarter. So, you know, we do have a bright future ahead, but that journey won't be a completely linear journey. So I think, and I'm just going to look here, I think that wraps up the questions on the web interface. We'll pause here. I think the operators will take over if there's any

uh live questions that would like to be asked ladies and gentlemen if you would like to ask a question please press star followed by the number one on your touch tone phone you will hear a prompt that your hand has been ranged if you would like to withdraw from the polling process please press star then the number two if you are using a speakerphone please make sure to lift your handset before pressing any case The first question comes from the line of Charles Chigal, private investor. Please ask your question.

Hi, thank you for the call. Can you tell me what it means when you have these interactions with these 74 new hospitals? How does that, what is that actually? Is that, that's not new business. How does that work?

Yeah, good morning, Charles, and thank you for the question. Really happy to talk about that. So those are 74 hospital customers in the United States that prior to 2025, we did not have any business and no revenue at. And so this is work that our sales and marketing team, our collective commercial efforts and our market development work has helped generate an interest in one or more products. And so within 25, Within 2025, we added those 74 customers that prior to the year starting, we had not had any revenue relationship with. Good question, thank you.

Can I just ask a follow up? Are there any ways you can increase your the possible interaction with these hospitals, like sending people in for demonstrations. Is that something you do normally?

Absolutely. Absolutely, Charles. So, uh, and this is why the metrics we put up on the page are, are relevant, right? Uh, first job is when we win new business, we don't want to lose it. We've done an outstanding job of that retained all the customers. We, we, uh, we, uh, our top 50 last year. Um, And then that middle metric around growing existing business, this is something that I think is really important for us as a company. So very important to win new business. But then when we get into an account, we typically get in, not always, sometimes in a bigger way. An example was the one I gave with children's, sorry, I almost slipped up and gave the name of the hospital, which the hospitals don't usually like us naming them. But that large Midwestern hospital large Midwestern Children's Hospital, where we got into 11 units housewide. But normally it's one product, one unit. And then from there, our team works with the hospital to expand. So it might be from the ICU or the NICU into the hematology, oncology, the cancer wards. It might be from just ValGuard to using ValGuard and IV Clear or CovaClear. And so that's a key part of what we do. The focus is really clear, right? It's how do we add new customers? And once we get in, how do we make Covalon's presence spread? How do we support these amazing nurses and infection preventionists to do the incredible work that they do? in a bigger way. And so we're really excited. And 2026, we've got some really exciting new things coming on that front and looking forward to sharing those with you in the coming meetings. So thanks, Charles. Good opportunity to allow me to explain a little more about what we do and how we do it. Are there other questions?

Okay. There are no further questions at this time, so I'll turn the call back over to Brent Ashton for closing comments. Sir, please go ahead.

Hey, thank you so much, Konstantin, and thanks to everyone on the call for joining us today. As you can probably tell, I'm incredibly proud of the progress our teams are making and the impact that we're having alongside our nurses and infection professionals and other clinicians who trust our products to help protect their patients. As I said on that answer to Charles, the work they are doing is incredible. I think all of us know a nurse, an infection preventionist, a doctor in our lives, the sacrifices they make under really challenging times. And it gives us a lot of pride that they trust us to help protect their precious patients. We've got real momentum. We've got a stronger foundation than ever and a clear path forward. I'm genuinely excited about where we're heading. And I appreciate the continued support from all of you as we advance Covalent's mission together. So on behalf of the entire Covalent team and our board of directors, I wish each of you all the best for the holidays. Stay safe and looking forward to the turn of the calendar to 2026. Thank you and have a great day.