Covalon Technologies Ltd.

for conference call and webcast. My name is Jenny, and I will be your conference operator today. As a reminder, today's conference call 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 questions via the webcast. Alternatively, if you would like to ask a question over the telephone, If you would press star, then the number one on the telephone keypad. If you would like to withdraw your question, please press star two. If at any time during this call you require immediate assistance, please press 4-0 for the operator. At this time, I would like to turn the conference over to Mr. Brent Ashton, Chief Executive Officer, and Ms. Katie Martinovich, Interim Chief Financial Officer. Please go ahead, Mr. Ashton and Ms. Martinovich.

Thanks, Jenny. And good morning to all of you on the call today. I hope that you all had a great holiday break here a week or two ago and are really excited at the recent turning of the calendar year here for 2025. We appreciate you connecting in today. Katie Martinovich, our interim chief financial officer, has joined me on the call here. And Salia Asadzada from Covalon is helping to coordinate the conference call and the webcast today. And she'll now provide us with some instructions.

Thank you, Brent. Good morning, everyone. My name is and I am the Executive Assistant to Covalent's Chief Executive Officer. I would like to thank everyone for taking the time this morning to attend our conference call. We will be discussing the financial statements, MD&A and press release related to Covalent's fourth quarter and full 2024 fiscal year ended September 30th, 2024. There will be an opportunity for you to ask questions at the end of the call. Before we begin the discussion, I would like to remind participants that this call and webcast are covered by Koblan's Safe Harbor Statement. Certain statements included on this conference call may be considered forward-looking. Such statements involve known and unknown risks, uncertainties, and other factors that may cause our actual results, performance, or achievements to be materially different from those implied by our statements. And therefore, these statements should not be taken as guarantees of future performance or results. All forward-looking statements are based on management's current beliefs, assumptions, and information currently available to us and related to anticipated financial performance, business prospects, partnership opportunities, strategies, regulatory developments, market acceptance, and future commitments, among other things. Participants on this conference call are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this conference call. Due to risks and uncertainties, including those identified by Kovalan in our public securities filings, actual events may differ materially from current expectations. Kovalan disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise. In the management's discussion and analysis, press release, and this call, Kovalan has provided non-GAAP financial measures that are meant to provide further understanding of our results by helping to highlight trends and assist in comparing different periods. The adjusted gross margin and adjusted EBITDA are terms that do not have any standardized meaning and may not be comparable to other companies. These measures are not meant to replace the similar IFRS accounting standard measures, and any adjusting items may recur in the future. I will now turn the call back over to Brent Ashton, Kovalan's Chief Executive Officer.

Thanks much, Sulia. Great to be able to speak with all of you today. During our call, I'll be covering three things. First, I joined Kovalan one year ago this past Saturday, and I'd love to provide you with my view on how exciting this past year has been and how much we've accomplished. Second, I'd like to talk to you about the excellent results of our fourth quarter and our 2024 fiscal year that ended on September 30th. And third, I also want to tell you that we have so much more we can do and will do in the next year and beyond. I'm electrified about the growth opportunities that lie ahead. This growth won't be completely linear and we're certainly in the early stages, but I'll be sharing some details that give the Kovalon team a lot of energy for our future as a company as well as some of the key areas of focus for us here in 2025. And after this, we'll take a Q&A from this audience. So jumping right in. It's been a year and three days since I joined Covalon. I came to this company with a strong background in the spaces that Covalon plays in, thanks to nearly 20 years of leadership roles at 3M and Becton Dickinson. And I came in with a ton of excitement and optimism for what we could accomplish in the short and long term. I really couldn't be more proud of what we've been able to achieve this past year, while also acknowledging that we're really just getting started on the multi-year journey to transform Covalent. A year ago, we reported our ninth consecutive quarter losing money, attributable to many things, including a large for our size, misaligned commercial organization that was just not generating the revenue needed to achieve profitability. Today, we're reporting our third consecutive quarter of greater than 30% growth and our third consecutive quarter of positive net income and EBITDA, really a function of a number of critical changes and focused areas of activities. These include the move to a smaller, more effective, customer-focused commercial organization that did a really solid job delivering growth in the areas that we directed them to. With a strong focus on our U.S. medical consumables business, this would be the combination of our U.S. advanced wound care business, where we sell primarily collagen dressings through our U.S. distribution partners, as well as our U.S. vascular access and surgical consumables business, where our Covalon team sells vascular access solutions and post-operative surgical dressings to U.S.-based hospitals and other providers. So in this focused part of Covalent, we were able to drive significant growth of more than 65% in 2024. And we accomplished this incredible growth with about a third of the sales team members that we had in place a little over a year ago. There's been a ton of progress on the operations front, strengthening our in-house manufacturing, making critical investments in our quality team and systems, advancing our regulatory approach, and implementing a sales and operational planning system to reduce excess inventory or back orders. These advancements and investments have been a large part of our 2024 margin expansion success. We've also paid significant attention to our operating expenses, being a lot smarter about what and where we are spending up and down the organization. On this front, we were able to decrease our operating expenses by a little more than $2 million for the full year, even while we grew the business by almost $5 million. So these areas of focus in 2024 led us to completely flip our income position and achieve full year adjusted EBITDA of almost $5 million. In 2024, we also generated strong free cash flow after several years of cash burn. When combined with the warrant exercise proceeds in September of 2024, this led us to increase our cash to almost $17 million at the end of September, an increase of nearly $8 million, which is almost double our cash position from a year ago. And with zero debt, this positions Kovalon very well for future actions to accelerate growth, reduce costs, and invest in an exciting future for our company. In previous earnings calls, I've alluded to the significant amount of work that was needed to clean up some of the challenges of the past and enable us to build a strong future. We've accomplished a lot, and this is setting Kovalon up with a much stronger foundation to build from. I am very grateful to the full Kovalon team for being willing to embrace change, do things differently, and drive a strong continuous improvement mindset. And perhaps most importantly, Covalent has an amazing family of products and technologies that save lives and improve patient quality of life and clinical outcomes. And as I reflect on the past year's activities, this is the area that really jumps out at me professionally and personally. It's been so incredibly gratifying to speak with patients and the clinicians who cared for them and just hear their stories that they shared in their own words, on the amazing benefits they saw to using our unique differentiated technologies. In the future, we'll look to share some more of these stories, but for now, one quick one. This is from a mother of a three-year-old child who was recently in Boston Children's Hospital to address some challenging cardiac and gastrointestinal issues, and they had to have a vascular access catheter inserted into his body to provide critical-to-life infusions. And what she told us was, My son is almost three, and we had a really hard time finding dressings that would stay on securely without causing his skin to break down and cause all sorts of other issues. The Boston Children's Care Team introduced us to Covalon's Ivy Clear Soft Silicone Dressing, and it has seriously saved his skin. I know I speak for the entire Covalon team when I say that it's really stories like this that motivate us to wake up each day focused on how we can get more of our amazing products in use for the people who need them so dearly. And while our share price has more than tripled over the past 12 months as a result of our strong progress and accomplishments, I don't believe that the market has fully appreciated the value of Covalent relative to the significant runway we have to create value in the coming years, nor in comparison to the multiples of other med tech companies. And so as we look forward, it's really clear that we have an amazing opportunity to unlock significant further value for our shareholders. So to sum up part one of our time together here, it really was a strong 2024. A lot of great accomplishments that we are proud of, but I can assure you that no one in Covalent, including myself, feel like we're ready to fly that mission accomplished banner. In fact, it's really just the opposite. We've only just begun. So with that as a backdrop, it feels like a good time to cover our Q4 and our full year 2024 financial results in just a little more depth. I'm going to cover some of the key highlights here, and we've included greater details, both in the appendix to this slide deck that's up on our website, as well as in our press release, our financial statements, and our MD&A, which are also all available on the Covalent IR website. Kovalon delivered on a really solid Q4 financially with almost $9 million in revenue, which represented growth of 29% year on year. We'll double click on that in the next slide. This strong growth over Q4 last year enabled us to deliver an adjusted EBITDA amount of $1.1 million in Q4. And then for the year, just over $31 million in revenue. That's a growth of 17%. And that growth was inclusive of a $2.5 million decrease associated with our past decision to shift focus and resourcing from the medical coatings business to the U.S. medical consumables business. Excluding this coatings piece, Covalent grew almost 30% in 2024. And with this strong growth, we were able to post adjusted EBITDA for the year of $4.8 million. a significant improvement from 2023. Excuse me. We did this all while spending a lot of time and effort cleaning up some of the company's challenges and driving sustaining efforts in order to establish a really solid foundation that will support our future growth. And that growth work is underway and accelerating as we turbocharge our demand generation activities and set the company up for long-term success. Going a little deeper into some key financial outcomes here, with the strong focus on that US medical consumables business, here you can see the exceptional growth that we have driven in this space, both for the quarter at 72% and the year at 66%. Margin-wise, a huge turnaround here from Q4 a year ago, as well as for the full year. The two big drivers here were on the operations side, where our continued optimization of our in-house manufacturing efforts delivered a lot of benefit, as well as additional help from product mix. And from an operating expense standpoint, a sizable reduction in operating expenses for the quarter and the year. A significant chunk of this decrease was the cost savings that were realized from the restructuring of the US commercial team. And this drove a 33% reduction in our overall sales and marketing expense for the year, But it's also worth noting that in a year where we took on a ton of sustaining work to build a strong foundation for the future, and a year where we grew the business by almost 20%, the total operating expenses for the company, excluding sales and marketing, only grew 5.8%. A ringing testament to smart operating expense management and a highly efficient Kovalon team. And then looking to income and cash. The $1.1 million in adjusted EBITDA in Q4 was a $2.9 million turnaround from a year ago and even more impressive for the year with a $7.5 million improvement from 2023. Earnings per share came in solid for the year at 11 cents per share, which was a big increase from last year's negative 29 cents per share. And from a cash position, as I alluded to earlier, a significant swing from the end of 2023 where between strong free cash flow generation and the warrant proceeds, we increased our cash position by almost $8 million to get to $16.7 million. And it's worth noting here that we do maintain the bulk of our cash position denominated in US dollars, which resulted in a positive currency benefit within 2024 and likely continues as we move forward here in 2025. And moving to the next slide, I wanted to provide a little more visibility and granularity to our U.S. vascular access and surgical consumables business, which it's a smaller portion of our revenues today, but it's a really important area of focus for Covalon and one that is growing rapidly. I'm going to show you a couple of database examples of the business that give the team and I a lot of optimism and confidence that our strategy is working. One thing right off the bat is that Covalent is a strong partner to the hospitals that if you wanted or needed the best care possible, these are the ones you would go to. In fact, of the 10 best US children's hospitals, according to the latest US News and World Report rankings, Covalent is a trusted partner to eight of these. We help these amazing institutions provide the best possible care via our unique and differentiated vascular access solutions and post-operative surgical dressings. As you'll recall, in the past 15 months, we did have to make a series of tough but very deliberate decisions to our U.S. medical consumable selling teams. To wit, of the 14 individuals who had U.S. sales as a primary role back in October 2023, only four of those individuals are still with the company, and we've added two new members to the team. We've also been implementing a new CRM system to add robustness around pipeline management, as well as general rigor and management attention to our sales and marketing focus. And with such a large amount of disruption in 2024, the U.S. Vascular Access and Surgical Consumables team had a very high focus on maintaining continuity with our largest and most important hospital customers. And the team did a stellar job here. We maintained all but one of our top 50 accounts, hospital accounts, that is, from 2023. And the one loss was more of a portfolio discontinuation decision. So that was some really solid execution. But even with all that distraction, our number two priority was to grow revenue at our existing accounts, increase the usage of products we already had adoption of, and then also cross-sell to add new products into play at the account. In a lot of cases, this meant some new introductions, introducing a new Kovalon employee to the customer, rebuilding relationships and whatnot. And here we also had a lot of success. we were able to grow our revenue at our top 50 hospital accounts from 2023 by 55%. And on the next slide, I'll go one step deeper on this. And then our third selling priority of 2024 was to add new customers to the mix. And here we had a solid outcome of adding 66 new hospitals to the Covalent family, which was a big increase from a year ago. So a lot of success here, even in a year with a lot of change. And now to look a little closer at the growth of existing accounts. This slide is another demonstration of the success of the commercial playbook. If we dig in and look at the 15 largest children's hospitals in the United States, and here we use the inpatient bed count from Becker's Hospital Review as the source. At the end of our 2024 fiscal year, Kovalon had business at 10 of these 15 big children's hospitals. And if you look at the growth that we've seen at most of these accounts in 2024, it really demonstrates the success of the strategy and the focus. All 10 of these large institutions grew at least above the market growth rate of about 5% in 2024. Eight of the 10 of these accounts grew revenue at least 50%, which is 10 times the underlying growth rate. And six of them more than doubled revenue, which is 20 times the market growth rate. So a huge thank you to our team for this outstanding accomplishment. And rest assured, you know, we aren't talking about small little revenue accounts here that move from $2,000 in 23 to $4,000 in 24. In the middle bubble here, you can see the expansion over the past two years of what we designate as a large account. These are hospitals that deliver more than $100,000 in revenue to Covalent in a given year. So within that same subset of the 15 largest U.S. pediatric hospitals you see at the top, in 2022, we had just one large account, these $100,000 accounts, one large account. In 2023, that increased to three large accounts, and last year it more than doubled to seven. Some amazing progress in the past 24 months. And obviously we still have a lot of opportunity for growth within these accounts, and they are a large area of focus here in 2025. And a special call out here for our ValGuard product line. Our ValGuard product is one of our newest products for Kovalon. We launched the product in late 2020, and it's quickly becoming a strong tool for customers looking to help reduce bloodstream infections in their patients. ValGuard is a transparent environmental barrier designed to protect catheter hubs and line connections from external contaminants and gross contamination, including bodily fluids and other secretions. We've seen strong early adoption, but really still miles and miles of runway growth here for the future. And looking at our sales growth here within these large, important children's hospitals, whose logos you see at the top of the screen, in 2024, our Valgar business at these large hospitals grew almost 80% overall, which was great to see. And we are driving hard to continue this strong growth curve. And I've deliberately chosen to go a little deeper into our U.S. vascular access and surgical consumables business because it's a really key part of our future for so many different reasons. And one of those reasons is that it represents a big part of our focused goal to transform Covalent into a more predictable, high-growth med tech leader. I've talked in the past, and I know this comes up in the Q&A period a fair bit, around lumpiness of our business. year to year variability quarter to quarter visit variability and really at the heart of it the makeup of our company they have different elements of predictability and continuity our international business largely concentrated in the middle east is our lumpiest of businesses driven by large bid and tenders with frequent timing shifts that delay or even cancel revenue we're not alone here this is very common in the industry in the past years In the past 10 years, actually, our lowest annual revenue was $1.4 million and our highest was $22 million. So you can see a ton of variability. Our medical coatings business was also a challenge as there were very few customers. And as we saw a couple of years ago, when your business really consists of one main large customer and that goes away, it creates a big void. In the past 10 years prior to 2024, Our lowest revenue year for coatings was $850,000, and our highest was $6.7 million. Again, a lot of up and down there. And that leaves our U.S. medical consumables business. Here, given the variability we've seen over the past decade on the two segments I just spoke about, it was a deliberate strategy for the company to overweight our growth focus on this business, which is more predictable than other pieces of covalent. And as you can see here, we've had a lot of success with this, moving this important business from 27% of our company's revenue a decade ago to 86% of our revenue in 2024. And in that same timeframe, we've grown revenue in our U.S. medical consumables business from $2 million to more than $25 million, a 10-year compounded annual growth rate of more than 33% per year, and most notably 66% growth in 2024. Now, this U.S. medical consumables business is not immune from lumpiness. On the U.S. advanced wound care business, we're not directly driving the demand generation efforts for our collagen products. That comes from our partners. And we do see these partners win and lose chunks of business, as well as building inventory in anticipation of business wins or bleeding it off if they lose business or the wins don't materialize to the degree first anticipated. But it's been much more predictable and steadier than our international or medical coatings business. And the US vascular access and surgical consumables piece, that is really critical. It does take a lot of work to get into these hospitals, but once it is in, it's a very sticky recurring revenue model. It will bounce around a little bit quarter to quarter, but much less variability than any of the other pieces of Covalent. And it is the one that we absolutely control from end to end the most. And so as we continue to grow and accelerate our US medical consumables business, we do expect to see better growth consistency. I'm gonna pause here for a water, one second here. Up here in Toronto, it's a little dry and a little snowy this morning. And so transitioning to the third part that I told you I would walk you through today around the piece of being so much more we can accomplish in the next year and beyond. Good question would be, hey, what are some of the key actions and areas of focus for 2025? And so the elements you see on the slide, they don't represent our plan nor the entirety of our focus for the future, but they are for really critical areas that will be high priority items for 2025. Nailing these in the months and quarters ahead doesn't guarantee five years of future success, but they are absolutely critical to enable the bright covalent future that I know is achievable. The first area is around our growth-focused commercial advancement. I highlighted earlier the success of the 2024 playbook in the medical consumables business, and it would be easy to say, hey, that play is working, just keep at it. But we know that in all of the areas we play in, we're still a smaller fish in a very large pond, and there's a ton of room for us to accelerate our growth in our advanced wound care business, in our vascular access and surgical consumables business, both in the United States and in international, and in spaces that we'll play in in the future. And although we still see a fair bit of distraction from a number of our competitors, they aren't standing still either. And so we have a lot of focus on how we can transform our commercial approach and accelerate our growth to get to scale. Delivering the most impactful tools and content to accelerate demand generation. Put our team members in the best possible situation to succeed with our customers. Utilize new technologies to improve productivity and accelerate our sales pipelines. My background historically has been on the commercial side, and this is my single biggest area of focus here in 2025, working with our commercial leadership and the full team to make an even greater impact here in 2025 and beyond. Second is accelerating our market development activities. Candidly, previous leadership at Kovalon did not put a high degree of focus on this. prior to my arrival, but it is the cornerstone of every successful large and small medical device company that I've seen in my past. When you boil market development down in the medical device context to its basics, it's really about educating clinical customers about the problem, the clinical problem. This could be medical adhesive related skin injury. It could be bloodstream infections or wounds that won't heal properly. Those are the problems. And then demonstrating that Kovalon technology helps to solve that problem through clinical evidence, testing data, or other means. And then ultimately communicating all of this to meet our customers where they are and how they want to receive information. It's also about building relationships and engaging with key opinion leaders and key influencers. These are typically clinicians who are well regarded by their peers. And there we want to tap into their expertise, and reach and work with them on clinical challenges that they are passionate about. We are playing catch up here, but I'm excited about how we've moved the needle in the past year. We've collaborated with key hospitals to advance two separate clinical evidence studies with customers that are eager to share the results of their research with the broader medical community. We're working closely with the study sponsors who are pursuing publication and peer reviewed journals targeting for later this year. We're also actively engaging with clinical researchers on new and exciting opportunities for collaborative evidence generation. The team is very, very energized on this front. Third area is around optimizing and evolving our operations. We made a lot of headway in 2024, especially related to scaling our operations to meet increased demand for our collagen product, investing in quality and compliance and other key activities. In 2025, a few areas of focus on this front. One is we're investing in automation and other manufacturing enhancements to drive out waste and cost out of our production process. We're also working to simplify and streamline our supply chain and several other actions in the operations area that we'll share in future conversations. And all of these activities will be well supported by the improved quality systems and processes that we made happen in 2024. And here's probably as good a spot as any to comment on the potential tariffs that have been in the news here the past couple of months. Of most relevance to Covalent would be the potential for an across-the-board 25% tariffs on goods entering the United States from Canada. There's certainly lots of opinions on if or how this will play out, And if it plays out, what would the Canadian economy look like? Or what would the Canadian dollar look like six months or a year from now? I'm not going to wade into the politics of all this, but it is important to note here that while we do manufacture the majority of our collagen in Canada, we've still maintained volume at our contract manufacturer in the United States. And if warranted, we could shift more volume back to the United States. But if these tariffs do come into play, our models would say the worst case impact would be a couple hundred basis points of margin pressure. And it's important to understand that we do have a number of options to reduce this potential impact. It's also worth noting that almost all of our revenue comes in U.S. dollars, but the majority of our costs are in Canadian dollars. So if this worst-case tariff scenario were to play out, it would seem to reason that the Canadian dollar would likely lose value against the U.S. dollar, which would then provide Covalon with a substantial translation benefit. And of course, we're constantly assessing the best manufacturing strategy for the future, ensuring we have the right drivers in place on quality, total delivered cost, and speed. And then last but not least, innovation and business development. While we're very focused and excited about the products and technologies we have today, we also have a large hopper of opportunities to advance around new products, new uses for existing products, and inorganic actions such as partnerships, mergers, and acquisitions. In 2024, with so much focus around our sustaining work, this wasn't a big area of activity. But in 2025, we are accelerating our activities here. We feel it's critical as we think about the company we want to be in the future. For competitive and confidentiality reasons, these aren't areas we can talk about publicly yet. And we're early on in the process. But I will tell you that the hopper is overflowing with opportunities on many, many different fronts. So lots of excitement here in 2025 and beyond. And so to wrap up today's call so that we can take some questions, a quick summary. The past year has been a really exciting one. The team accomplished a lot in a short amount of time and has been open to a lot of change. It was a strong Q4 and a strong year overall. Really proud of the work of the full team to make that happen. A lot of critical actions and outcomes that led to the success of Q4 and 2024. And then the future is bright. We have visibility to a very significant multi-year growth opportunity here at Kovalon. Hopefully I've given you some glimpses into what we're doing and what we're shooting for here. It's going to be a very exciting journey and we really appreciate your strong support. And so with that, we're gonna 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 a couple of minutes of a pause here to allow time for questions to be answered, and then we'll have Celia triage the questions for us. She will announce the question and who the question is from, and then Katie or I will provide the answers. If time permits afterwards, we'll open the lineup for verbal questions.