HLS Therapeutics Inc. ($HLS)

Good morning, and welcome to the Q1 Fiscal 2026 financial results conference call for the HLS Therapeutics. At this point, I would like to turn the call over to David Mason, Investor Relations for the introductory remarks.

Good morning, everyone, and thank you for joining us today. With me on the call is Craig Millian, Chief Executive Officer; John Hanna, Chief Financial Officer; and Brian Walsh, Chief Commercial Officer. Earlier this morning, we issued a news release announcing our financial results for the 3 months ended March 31, 2026. This news release, along with our MD&A and financial statements, is available on our website and on SEDAR+. Please note that slides accompanying today's call can be viewed via the webcast, a link to which is available in our earnings press release and on our website on the Events page. Certain matters discussed in today's conference call or answers that may be given to questions could constitute forward-looking statements. Actual results could differ materially from those anticipated. Risk factors that could affect results are detailed in the company's annual information form, which has been filed on SEDAR+. During the call, we will refer to adjusted EBITDA. Adjusted EBITDA does not have any standardized meaning prescribed by IFRS. Adjusted EBITDA is defined in our press release and annual filings that are available on SEDAR+ and on our website. Please note that all financial information provided is in U.S. dollars unless otherwise specified. And I would now like to turn the meeting over to Mr. Millian. Please go ahead.

Thanks, Dave. Good morning, everyone, and thank you for joining us today. On our call today, I'll take you through our Q1 performance, along with a corporate update. Brian will then follow with a deeper look at performance for each of our products with a focus on the NILEMDO launch. John will cover the financials in detail, and then I'll be back with a few closing thoughts before we open it up for questions. Starting with the big picture. We believe today's HLS is in a very favorable position, but Vascepa is still growing in its 7 in the market, Clozaril is showing resilience and NILEMDO is off to a great start, better than expected in many respects. Over the past couple of years, we've put HLS on a solid operational and financial footing, making necessary improvements to increase efficiency and profitability while delevering our balance sheet. In addition, we brought in 2 important new assets last year, NILEMDO and NEXLIZET that we believe will be important catalysts for growth. With a stronger financial foundation and expanded cardiovascular portfolio, we're now focused on accelerating growth in the years to come. With that, let me start by walking you through the first quarter highlights. Starting with the top line. Revenue in Q1 was $12.9 million, up 2% year-over-year. That growth was led by a 15% increase in Vascepa net sales, the highest year-over-year quarterly growth we've seen since Q2 of last year. This is encouraging in that the leadership and staffing changes, along with the commercial strategy that we put in place last year are having the desired impact. Adjusted EBITDA for the quarter was $3.5 million, down about $300,000 from the prior year, and that is as expected. As previously discussed, we're making a small increase in commercial investment to help ensure a successful NILEMDO launch. We expect that launch-related expenses will be mostly front-loaded in the first half of the year, with margins improving in the second half as spend normalizes and NILEMDO revenue ramps up. Cash from operations was up 80% year-over-year. And on the balance sheet, net debt at the end of Q1 was $31.9 million, down 52% in just 2 years. This delevering has strengthened our financial position and will increase our options through deploying capital. Now a few comments on our business performance. Turning to Clozaril. Q1 results were in line with expectations. As discussed on the last call, Clozaril encountered some contracting dynamics in Ontario in the latter part of 2025. And as expected, this is impacting year-over-year comparisons in the first half of 2026. And while we are seeing those residual impacts, we're also seeing positive signs that our business is stabilizing. Most encouraging is that we saw a sequential return to Clauser monthly patient growth in Ontario specifically and across Canada more broadly in both March and April. Month-to-month growth in our patient base is a positive leading indicator suggesting business results should follow. Regarding Vascepa, we're encouraged by the strong prescription and net sales growth seen in the first quarter. For full year 2026, we're projecting double-digit growth in both prescriptions and revenue. With sustained demand growth and increasingly stable payer mix and a cost structure that's now spread across multiple products, Vascepa should contribute growth along with market expansion for years to come. Now let's turn to NILEMDO, which had its full commercial launch in April. With just over 1 full month on the market, we've shipped nearly CAD 0.25 million worth of NILEMDO. Multiple wholesalers are placing reorders based on strong initial demand and the weekly run rate for ex-factory sales is growing. On the private payer side, Canada Life and Sun Life, 2 of the largest plans in Canada are already listing Nilemdo with full coverage and without restrictions. These 2 plans cover about 40% of all privately insured patients in Canada. Although early, we're pleased with how this launch is progressing. Regarding NEXLIZET, the fixed-dose combo pill combining bempedoic acid and ezetimibe, we expect to respond to Health Canada on their outstanding queries this quarter, keeping us on track to launch in the first half of 2027. The sequencing of the NILEMDO launch in Q2, followed by NEXLIZET, in the first half of 2027, is HLS 2 distinct growth catalysts within 12 months. From a big picture perspective, HLS is becoming a leading Canadian cardiovascular company. We have a growing portfolio of oral first-in-class medicines, each with compelling outcomes data, long pattern runways in Canada and a distinct role in addressing cardiovascular risk. And although we'll be tripling the number of products in our CV portfolio, the increased investment required is modest. We believe these dynamics add up to a unique and perhaps underappreciated opportunity as the economics of our cardiovascular franchise model are compelling. First, there are the expanding margins. We're leveraging existing infrastructure with no need to expand our customer base and footprint. With a stable cost structure as we introduce these new medicines and as sales volumes increase, the cardiovascular portfolio will become significantly more profitable in years to come. And second, the revenue opportunity here is significant. Based on what we believe are conservative assumptions, the NILEMDO and NEXLIZET franchise has the potential to more than double the size of the company. For those of you on the webcast, we're showing a slide with an illustrative example of how we're thinking about revenue potential for the NILEMDO and NEXLIZET franchise. Based on conservative estimates for peak market penetration of the target population, along with preliminary assumptions around patient compliance and gross to net, we get to a revenue range of CAD 50 million to CAD 100 million. Again, at that level, we would essentially double the size of the company. And we believe there could be additional upside to our assumptions. That said, I want to caveat that we will have a more fully formed view on peak sales potential once we finalize public payer negotiations by early next year. The bottom line is that NILEMDO and NEXLIZET are entering a sizable market, targeting a well-defined patient population with unmet need, and we are in a great position to capture this opportunity. Let's move on to guidance, where we are reaffirming our 2026 outlook. Revenue of $56 million to $60 million, reflecting mid-single-digit growth and adjusted EBITDA of $18.5 million to $21 million, which is relatively flat as we absorb the NILEMDO launch costs. As I mentioned, the launch investment is concentrated in the first half. We expect to see margin expansion as sales momentum picks up in the second half of 2026 and into 2027. This is reflected in the quarterly gating for adjusted EBITDA, where we expect a higher split in the second half of the year. So while 2026 is a year of incremental investment, the real growth story for HLS becomes the trajectory heading into 2027. And I'll come back to that in my closing remarks. But for now, let me hand it over to Brian.

Thanks, Craig. Good morning, everyone. I'll take you through our products, starting with Clozaril and Vascepa, then focusing on the NILEMDO launch. Starting with Clozaril Canada, Q1 results were as anticipated. Due to the 2025 Ontario GPO renegotiations that we've detailed previously, year-over-year comparisons will be unfavorable in the first half of the year and are expected to normalize in the second half. Importantly, patient volume in Ontario returned to sequential growth in March and again in April, evidence the changes have been worked through, and we are expecting continued sequential patient growth in Ontario throughout the year. We also continue to see high patient retention in Quebec, while other provinces are showing solid growth. British Columbia, in particular, delivered 11% patient growth versus Q1 last year. The Clozaril fundamentals are intact, the largest strategic accounts were retained and patient volumes are growing again in Ontario and across Canada overall. The brand maintains approximately a 50% market share and remains a strong, stable cash contributor. As for Clozaril in the U.S. revenues were down 2%, in line with expectations. We expect to take a modest and customary price increase later this year and we'll continue to look for ways to maintain patient volumes and expand the specialty pharmacy program to bolster this business. On Vascepa, Q1 unit growth remained strong at 18% versus prior year and net sales growth strengthened, a validation of the go-to-market changes we made in 2025. New-to-brand prescription improvements that began in Q4 2025 continued into Q1. Prescriber breadth and depth are both tracking positively, demonstrating that we are not just deepening prescribing with existing writers, but also expanding the prescriber base. And payer mix continues to stabilize, which should help improve the profitability of the brand. Vascepa has patent protection through late 2030s, and we see a long runway for continued profitable growth. Now let's turn to NILEMDO. The opportunity is well defined. In Canada, roughly 5 million to 6 million Canadians live with cardiovascular disease or elevated cardiovascular risk, 3 million are on statins. We are targeting a clearly identified subset. Those not reaching their LDL goal despite treatment and those that cannot tolerate statins or cannot titrate to an effective dose. Bempedoic acid works outside the muscle tissue, avoiding the side effects of many patients experience on statins. We estimate that population conservatively at 0.5 million Canadians a large reachable group with a clear clinical need. From a pricing perspective, NILEMDO is priced at CAD 425 per day. That places it squarely in the gap between generic statins and more costly PCSK9 injectables, which are approximately CAD 15 to CAD 20 per day. And it's worth noting that PCSK9 inhibitors have less than 1% market share of LDL lowering therapy in Canada. This is largely due to the access restrictions that are in place. NILEMDO fills that gap with an oral, well-tolerated option at a price point to payers and physicians can genuinely get behind. The formal commercial launch for NILEMDO occurred in April, and early indicators are that we are off to a very strong start. Our reps are reporting something that you rarely see at launch, large numbers of clinicians who already have lists of their patients identified and who are ready to prescribe NILEMDO. These are statin intolerant patients who have been waiting for an oral option. Clinicians are familiar with the drug and have been following its real-world progress in the U.S. and Europe. They are excited by the CLEAR-outcomes trial data and have been waiting to have this option available for their Canadian patients. Our awareness, trial and usage, or ATU study, a blinded market research study that was completed in January provides us with imperial evidence on the baseline of awareness and readiness of physicians to prescribe in Canada. The study was comprised of 70 target cardiologists and endocrinologists, and it showed over 90% total awareness before we had promoted the product at all. These physicians follow the same global guidelines in literature as their U.S. and European peers, and NILEMDO has been part of that landscape for years. Over 80% indicated willingness to prescribe. Our National Advisory Board echoed the same message, clear unmet need and strong physician anticipation. We expect this ex-factory demand to accelerate in the coming weeks as awareness grows around the private payer access we achieved in April. Canada Life and Sun Life, two of the largest private payers in Canada have now listed NILEMDO as a full benefit with no prior authorization. Canada Life was in effect for the commercial launch and Sun Life went effective on April 29. Together, they represent approximately 40% of privately insured lives. These early listings are evidence to the value proposition for the brand is resonating. Active discussions with the remaining major private insurers are progressing well and we expect the vast majority of private insured patients will have coverage by the time we report Q2 earnings. On public reimbursement, our dossier has been submitted to both CDA and NS with their evaluations expected this summer. That will feed into PCP negotiations, targeting initial provincial listings in the first half of 2027. On NEXLIZET, we are expecting approval and launch in the first half of 2027. We think of NILEMDO and NEXLIZET separate but connected catalysts. NILEMDO establishes the foundation physician familiarity with the mechanism, the outcomes data and the patient population. Within a year, we follow with NEXLIZET, a fixed-dose combination delivering greater LDL lowering with less pill burden, a natural step for a position already writing NILEMDO. From a reimbursement standpoint, we expect to be able to converge the NILEMDO and NEXLIZET timelines, meaning the public listing process for NEXLIZET does not need to start from zero. This is a meaningful structural advantage of the staged approach. One further note, European LDL guidelines have moved from 1.8 to 1.4 mill per liter for very high-risk patients. We expect Canadian guidelines will follow. A review is expected within the next 12 to 24 months. This would expand the addressable population meaningfully, and this would occur after the NEXLIZET launch. This upside is not in our current estimates. Finally, as it relates to economics, NEXLIZET adds a third product on the same commercial infrastructure with modest incremental investment required. With NILEMDO gaining momentum in 2026 and both products in market in 2027, we have a lot to look forward to in the cardiovascular franchise. With that, I'll turn it over to John for a detailed look at our financials. John?

Thank you, Brian, and good morning, everyone. In my section, I'll review Q1 results, the balance sheet and our capital allocation priorities. My comments are all in U.S. dollars as per our reported numbers unless otherwise stated. Starting with revenue. Total revenue for Q1 was $12.9 million, up 2% from $12.6 million in Q1 last year. The increase is due to growth in Vascepa net sales, which were $4.8 million, up 15% from Q1 last year. As well as appreciation of the Canadian dollar to the U.S dollar. Clozaril net sales, Canada and U.S. regions combined were $7.8 million compared to $8.2 million in Q1 last year. Clozaril net sales in the U.S. were down slightly in Q1. While in Canada, Clozaril net sales in Q1 were impacted by the factors discussed by Craig and Brian. Finally, royalty revenue was $246,000 in Q1 compared to $197,000 in Q1 last year. On the expense side, Q1 operating expenses comprising sales and marketing, G&A and medical, regulatory and patient support were $6.7 million compared to $6.4 million in Q1 last year. The increase reflects our investment in the NILEMDO launch, which accounted for approximately $0.5 million of incremental OpEx. Cost of sales in Q1 was $2.7 million compared to $2.4 million in Q1 last year, with the increase largely due to demand growth in Vascepa. Q1 adjusted EBITDA was $3.5 million compared to $3.8 million in Q1 last year. Adjusted EBITDA was impacted by the NILEMDO launch investment as just described. As we have discussed, launch costs will be largely confined to the first half of 2026, with margins improving as we move through the second half of the year. There is generally seasonal quarterly variation in adjusted EBITDA. As those of you on the webcast can see on this slide, we expect a similar pattern in 2026. Though more pronounced in the first half given the NILEMDO launch investment with revenue beginning to ramp in Q2 and accelerating through the second half of the year. For Q1, the direct brand contribution from Clozaril to adjusted EBITDA was $5.6 million. In addition, even with additional launch expense, the direct brand contribution from the entire CV portfolio was breakeven in Q1. Cash from operations in Q1 was $6.4 million, up 80% compared to Q1 last year. The increase reflects the operational improvements made over the past 2 years, along with significantly lower interest expense $0.7 million in the quarter compared to $1.7 million in Q1 last year as a result of the new credit agreement and lower debt balance overall. Our focus on operational improvements has increased our profitability and generated the strong cash flows that are enabling our balanced capital allocation approach today. Our balanced approach for capital allocation allows us to accomplish multiple objectives. First, deploying capital to expand our portfolio with our balance sheet now in much better shape, we have greater flexibility to pursue additional opportunities. We are primarily focused on commercial stage assets in our core or adjacent therapeutic areas that can leverage our existing infrastructure. Second is to continue to delever the balance sheet by paying down debt. In Q1, we made principal repayments totaling $5.1 million. At March 31, 2026, the principal balance on our term loan stood $44.2 million, down 12% from the end of 2025. As a result of our continued delevering net debt stood at $31.9 million at the end of Q1, down 17% from the end of 2025. And thirdly is the return of capital to shareholders via share buybacks. During 2025, we purchased more than 500,000 shares. Although we do not currently have an active NCIB in place, we will explore opportunities to launch one in 2026 as we believe the shares represent compelling value at current prices. Finally, looking at the balance sheet. Cash was $12.3 million at quarter end, up from $11.7 million at the end of 2025. In summary, as we look ahead, we will continue with our balanced view to capital allocation, debt repayment, investing in growth and returning capital to shareholders. With our strengthened balance sheet and improved cash flow profile, we are increasingly well positioned to be more active on the business development front. And with that, I'll pass it back to Craig for his closing comments.

Thanks, John. Before we open it up to Q&A, 3 quick thoughts on why we think this is a compelling time to pay attention to HLS. First, with significant growth in adjusted EBITDA and cash from operations, along with a substantial reduction in net debt, we are a fundamentally stronger company than we were even just 12 months ago. Second, with NILEMDO, we've launched an important medicine with exciting potential, and the launch is going well. Physician awareness was over 90% before we made a single sales call. Ex-factory sales run rate is tracking well, and we've already achieved full coverage at both Canada Life and Sun Life. These early signals are positive. And third, the acceleration is ahead of us, not behind us. Private payer coverage will continue to ramp throughout this year. We expect to achieve public payer reimbursement in early 2027, and we expect to launch NEXLIZET the combination pill in the first half. We're confident that the NILEMDO/NEXLIZET franchise has the potential to more than double our business with patent protection running into the late 2030s. And with our balance sheet in the best shape it's been in years, we have the firepower to do more business development. So the portfolio is in place, the team is executing and the catalysts are in front of us, and we look forward to keeping you updated. That concludes my prepared remarks. And at this point, I'll ask our operator to please provide instructions for asking questions. Operator?

[Operator Instructions] Your first question comes from Michael Freeman from Raymond James.

Congratulations on these results and all the exciting things happening. I wonder if you could just give us a bit more color on the NILEMDO launch, how you're staging this launch positions you're targeting sales force you're deploying. And as much as much information as you can share on its reception and signals of growth and the help of this launch.

Brian?

Michael, thanks for the question. So we've maintained a commercial cardiovascular infrastructure in Canada for a number of years now with the medical science liaison team that's been established across Canada and the sales force over 20 individuals were experienced in cardiovascular specialty. So that's our team to take this portfolio to the next level. We fully trained the team at the beginning of April on NILEMDO. The medical team has been out for about a year since we first licensed the deal, engaging with key opinion leaders and we activated the sales team with this launch in April. We've been seeing as indicated in some of my remarks, very positive reception from physicians through advisory boards from payers through initial discussions. The value proposition is resonating very well, where there's the unmet need for an affordable oral option and the speed to these early listings, and we believe more to come in the coming weeks show that that's resonating well. They're making this product available quickly and with limited -- with no restrictions for patients. So importantly, physicians we expect to be able to write the product, patients go to the pharmacy and get the prescription. So all things are going well. I would say, even ahead of our ambitions on the private payer side, and we'll work through the plan with respect to public reimbursement, as I detailed, more in negotiations later part of this year.

Yes. And I'd like to just add a few thoughts, Michael, a couple of things. So one is to launch, we had a set of -- we have many KPIs and at this point, all of them are ahead of plan. So we don't have prescribing data yet. That will come soon, and we'll certainly be able to report that on future calls. But if we look at the leading indicators, looking at our sales ramp every week, although we've only been on the market one full month in April and then the parts of May. Every week, we're seeing significant increase in shipments, including reorders from wholesalers, which is a good indication that there is pull-through at the pharmacy level and physicians are prescribing. We're hearing very positive anecdotes from our reps in the field. We also are ahead of plan, I would say, in terms of our private payer coverage. So it's interesting as we're seeing this demand despite the fact that we're just now getting these plans on board. So that should be another catalyst. And as Brian mentioned, we've got the 2 large ones already covering NILEMDO and a number of other large private payers, we're in active discussions with, and we expect those will be on board as well in the next couple of months, certainly ahead of when we report Q2 earnings. So those are all very positive. The last thing I'll say is what's also very encouraging is that kind of the synergy we're seeing with Vascepa. And I think the fact that we're seeing significant growth in Q1 for Vascepa is not an accident. I think our thesis was that the rising tide will lift all boats and that bringing in frankly, upgrading some of our talent at least in commercial leadership and in the field and bringing in kind of a highly motivated experience people to launch NILEMDO there would be some very positive halo effects on Vascepa, and we're seeing that as well. So all signs are really, frankly, ahead of where we thought we would be at this point, which is very exciting. I don't want to get ahead of my skis because it is early. So I don't want to be hyperbolic here, but I think we're just very pleased with how this is all playing out.

Thanks for the reminder on the Vascepa synergy. That's an important way point. I wonder, for my second question, I wonder if you could comment on these 2 events and read-throughs to HLS. One, you did mention the European recommendations on LDL levels. And I wonder if you could speak a little bit more about potential impact should Canada pursue a similar policy. And then any read-throughs on NILEMDO, NEXLIZET developer being acquired recently. How should we think about that in the frame of HLS investment?

Sure. So I'll start with the second question and maybe let Brian speak to the first one. So as far as the acquisition recently announced related to Esperion, no impact. We did no impact whatsoever in our conversations with our partner, same level of commitment, business as usual on a go-forward basis. And again, I don't want to speak to them, but I think they very much view operations to continue as they have. So we very much view this as a nonevent as it relates to impact on our business in Canada. And then as far as the recent guideline changes, which continues kind of thematically, the idea that lower is better as it relates to LDL cholesterol and the fact that the vast majority of patients despite the availability of statins for decades are not -- many are not getting to goal, either due to currently efficacy or due to the inability to get to enough dosage without experience and side effects that they can't get to their LDL goal. So this change in guideline, we vision will actually expand the patient pool as far as patients who previously might have been at goal, I think of things in terms of milligrams per deciliter. So getting -- it used to be 100 that was lowered to 70, it was 50 for high-risk patients, which is going to require even more aggressive treatment. And I think that fits very well certainly with our combo pill, which achieves up to 38% LDL lowering.

Yes, I would just add, I think we've spoken to a number of opinion leaders, many involved with the guidelines in Canada. And although we expect it will take 1 to 2 years for the Canadian guidelines to reflect they and really the community are looking to the U.S. and European guidelines and incorporating that into their behaviors today. As we indicate these listings that we're getting or not come with restrictions. So as physicians adapt their behavior they'll be able to use NILEMDO where they see appropriate to meet the goals that they have for their patients. So we think even though the guidelines will lag in Canada, the behavior will change well ahead of that. And we're continuing -- we'll be -- we're doing work to quantify that, but it's not a factor that's based on the numbers that Craig shared in terms of the starting addressable population.

Okay. And just so I have it right, could you repeat what the prior level was and what it's been reduced to now?

Yes, as currently in Canada, it's 1.8 millimoles per liter, and the European guidelines are indicating to 1.4 millimoles per liter for high-risk patients.

[Operator Instructions] And there are no further questions at this time. I will turn the call back over to Craig Millian, CEO, for closing remarks.

Great. Thank you. So thanks, everyone, for participating, especially I know there's a long holiday weekend coming up in Canada. So I appreciate that and wish everyone a happy holiday weekend. And we look forward to continuing to report on our progress in the coming quarters and speaking again to you all very soon. Take care.

Ladies and gentlemen, this concludes today's conference call. You may now disconnect. Thank you.