TSE:HLS HLS Therapeutics Q2 2026 Earnings Report C$3.87 -0.03 (-0.77%) As of 03:59 PM Eastern ProfileEarnings HistoryForecast HLS Therapeutics EPS ResultsActual EPS-C$0.03Consensus EPS N/ABeat/MissN/AOne Year Ago EPS-C$0.09HLS Therapeutics Revenue ResultsActual Revenue$14.67 millionExpected RevenueN/ABeat/MissN/AYoY Revenue GrowthN/AHLS Therapeutics Announcement DetailsQuarterQ2 2026Date8/12/2026TimeBefore Market OpensConference Call DateWednesday, August 12, 2026Conference Call Time10:00AM ETConference Call ResourcesConference Call AudioConference Call TranscriptSlide DeckPress ReleaseEarnings HistoryCompany ProfileSlide DeckFull Screen Slide DeckPowered by HLS Therapeutics Q2 2026 Earnings Call TranscriptProvided by QuartrAugust 12, 2026ShareShareShare This ReportLink copied to clipboard.Key Takeaways Positive Sentiment: Cardiovascular portfolio growth accelerated: Q2 net sales rose 25% year over year, led by 18% Vascepa growth and NILEMDO’s first full quarter of sales exceeding $300,000. Positive Sentiment: NILEMDO access and uptake are progressing ahead of plan. Nearly 1,200 patients had started treatment by the end of Q2, private-payer coverage now reaches approximately 80% of privately insured Canadians, and public reimbursement negotiations are expected to begin later this year. Positive Sentiment: Additional growth catalysts are approaching: NEXLIZET remains on track for a Health Canada decision by year-end and a potential launch in the first half of 2027, while management expects NILEMDO momentum to strengthen in the second half of 2026. Neutral Sentiment: CLOZARIL trends were mixed but improving in Canada. The Canadian branded patient base grew for five consecutive months and Q2 sales declined only 1%, while U.S. sales fell to $3.0 million; management expects relatively flat U.S. year-over-year comparisons in the second half. Positive Sentiment: Management reaffirmed 2026 guidance of CAD 56–60 million in revenue and CAD 18.5–21 million in Adjusted EBITDA, citing expected second-half margin expansion, lower interest costs, debt reduction, and an active share buyback program. AI Generated. May Contain Errors.Conference Call Audio Live Call not available Earnings Conference CallHLS Therapeutics Q2 202600:00 / 00:00Speed:1x1.25x1.5x2xTranscript SectionsPresentationParticipantsPresentationSkip to Participants Operator00:00:00Good morning, and welcome to the second quarter fiscal 2026 financial results conference call for HLS Therapeutics. At this point, I would like to turn the call over to Dave Mason, Investor Relations, for the introductory remarks. Please go ahead. Dave MasonInvestor Relations at HLS Therapeutics00:00:15Good morning, everyone, and thank you for joining us today. With me on the call are Craig Millian, Chief Executive Officer, John Hanna, Chief Financial Officer, and Brian Walsh, Chief Operating Officer. Earlier this morning, we issued a news release announcing our financial results for the three and six months ended June 30, 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. Dave MasonInvestor Relations at HLS Therapeutics00:01:16Risk 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 USD, unless otherwise specified. I would now like to turn the meeting over to Mr. Millian. Please go ahead. Craig MillianCEO at HLS Therapeutics00:01:56Thanks, Dave. Good morning, everyone, and thank you for joining us today. On our call today, I'll take you through our second quarter performance along with a corporate update. Brian will then follow with a closer look at each of our products. John will cover the financials in detail. I'll be back with a few closing thoughts before we open it up for questions. Starting with the big picture. The story of this quarter is the acceleration of our cardiovascular growth engine. Our cardiovascular portfolio delivered second quarter net sales growth of 25% year-over-year, driven by double-digit Vascepa growth along with a strong first quarter of sales for newly launched NILEMDO. At the same time, our CLOZARIL patient base in Canada has grown sequentially for five consecutive months, including July. This is a positive sign that business is stabilizing. Craig MillianCEO at HLS Therapeutics00:02:54HLS is consistently generating cash, and with the strongest balance sheet in many years, we can invest in growing the company while also returning capital to shareholders. Now let's briefly review the second quarter financial highlights. Starting with the top line. Revenue in Q2 was $14.7 million, up 3.5% year-over-year. The cardiovascular portfolio led the way with a 25% increase in net sales in both local and reporting currency. Vascepa net sales grew 18%, which was a slight improvement over the strong growth it had in the first quarter. NILEMDO, in its first full quarter on the market, generated over $300,000 in net sales. This is slightly ahead of our forecast and particularly encouraging in that meaningful private payer coverage only started to take effect late in the quarter. Craig MillianCEO at HLS Therapeutics00:03:52In addition, as we announced last week, NILEMDO has now secured reimbursement with the largest private payers in Canada and achieved the unanimous recommendation for public reimbursement from Canada's Drug Agency. Brian will take you through greater detail on the NILEMDO launch and the near-term catalysts on the horizon. Turning to CLOZARIL. In Canada, the trend we highlighted last quarter continued, with consistent monthly gains in the base of patients on branded CLOZARIL. Net sales were down just 1% versus the second quarter of last year in both local and reporting currency, a further positive sign that the business is stabilizing. In the U.S., Q2 CLOZARIL net sales were down versus the prior year and are down about $600,000 year to date. Craig MillianCEO at HLS Therapeutics00:04:46This is in part due to a slight decrease in demand, but also reflected a challenging year-over-year comparison as the second quarter of last year accounted for 28% of full-year U.S. CLOZARIL sales. We expect a relatively flat year-over-year sales comparison for U.S. CLOZARIL for the second half of 2026. Adjusted EBITDA for the quarter was $4.7 million, about 10% less than prior year, similar to the Q1 decline, and in line with our expectations related to the incremental first half launch investment in NILEMDO. As we're now seeing the expected uptick in revenue growth driven by the NILEMDO launch, we expect margin expansion for our cardiovascular portfolio in the coming quarters. Even with the incremental investment to launch NILEMDO, and with only one full quarter of sales, the direct brand contribution from our cardiovascular portfolio is breakeven for the year. That brings me to capital allocation. Craig MillianCEO at HLS Therapeutics00:05:54Over the past couple years, we set out to put HLS on a stronger financial footing, and that work is largely done. We have successfully delevered the balance sheet, reduced our interest costs and built a business that is now consistently generating significant cash flow. Cash from operations is up 14% year-to-date, which reflects the operational improvements made over the past two years. With that foundation in place, our capital priorities have shifted to responsibly investing in new growth opportunities and returning capital to shareholders. In June, we launched a Normal Course Issuer Bid for up to 1.5 million shares and have been active buyers since. On the growth side, we continue to pursue business development opportunities that are consistent with our strategic focus, organizational capabilities, and financial resources. Craig MillianCEO at HLS Therapeutics00:06:52HLS is highly regarded as a potential partner in Canada based on our capabilities and customer relationships in specialty therapeutic areas. Our intent is to bring in assets at a reasonable cost that can meaningfully grow the top line, are accretive in the near term, and allow us to more fully leverage the infrastructure we've built in Canadian specialty markets. With our balance sheet in great shape, we will remain disciplined in our approach with the capacity to act when attractive opportunities present themselves. Moving to guidance, we are reaffirming our 2026 outlook. Revenue of $56 million to $60 million and Adjusted EBITDA of $18.5 million to $21 million. Consistent with the quarterly gating we outlined last quarter, we expect year-over-year Adjusted EBITDA comps to improve in the second half of the year as the cardiovascular portfolio revenue continues to ramp. Craig MillianCEO at HLS Therapeutics00:07:54With that, let me hand things over to Brian. Before I do, you may have noticed in Dave's introduction that Brian is now our Chief Operating Officer. Brian has been an impactful leader since joining HLS three years ago as Chief Commercial Officer. In his expanded role, Brian will continue to lead our commercial organization and will also oversee our field medical and patient support functions, creating even stronger alignment at the field and customer level. Brian, over to you. Brian WalshCCO at HLS Therapeutics00:08:24Thanks, Craig. Good morning, everyone. I'll take you through the portfolio this morning, starting with our cardiovascular growth drivers, Vascepa and NILEMDO, then CLOZARIL in Canada and the U.S. Starting with Vascepa, net sales grew 18% in Q2 year-over-year, and units grew 16%. Year-to-date, net sales grew 14% and units grew 17%. That's our second consecutive quarter of double-digit growth, reflecting the changes we made to the cardiovascular sales team in 2025. Prescriber breadth and depth both continue to track positively, meaning we are expanding a writer base, not just deepening it, and payer mix remains stable, supporting brand profitability. With patent protection through the late 2030s, Vascepa remains a durable growth driver in its seventh year on the market and will become an increasingly meaningful contributor to margin going forward. Now to NILEMDO, which completed its first full quarter on the market. Brian WalshCCO at HLS Therapeutics00:09:26Net sales were ahead of forecast, with wholesaler reorders continuing and the weekly ex-factory run rate strengthening as the quarter progressed. I've shared previously the enthusiasm that prescribers across Canada have shown for NILEMDO. Many reported having created lists of their patients that they've pre-identified for this therapy. In Q2, we witnessed this excitement translate to action, where at the end of Q2, prescribers had started nearly 1,200 new patients on NILEMDO, as measured by new-to-brand RX, or NBRX. For comparison, this is about 3.5 times greater than where Vascepa was at the same point in its launch. What makes these early results especially encouraging is that most of the quarter was ahead of the full private coverage now coming into effect in Q3. On that front, private payer access is running ahead of our plan. Brian WalshCCO at HLS Therapeutics00:10:19As we announced on August 5th, we have now secured reimbursement with the largest private payers in Canada, representing approximately 80% of privately insured Canadians. The vast majority of these patients can now access NILEMDO as a full benefit without restrictions. Several of these agreements are already in effect, with the remainder taking effect during the third quarter. On the public side, also announced, Canada's Drug Agency has finalized its reimbursement recommendation for NILEMDO, with its expert committee voting unanimously to recommend reimbursement by participating public drug plans. This opens the window for us to begin negotiations with the pan-Canadian Pharmaceutical Alliance for product listing agreements. We intend to commence these negotiations later this year, keeping us on track for initial provincial listings in the first half of 2027. Brian WalshCCO at HLS Therapeutics00:11:11On NEXLIZET, the fixed-dose combination, we remain on track for a Health Canada decision by year-end, with launch to follow in the first half of 2027. As we have described, NILEMDO is a differentiated new entity, bempedoic acid, and it establishes the foundation. Once approved, NEXLIZET, which combines bempedoic acid with a commonly used lipid-lowering drug, ezetimibe, will bring the combined benefits of both medicines to patients in one daily pill. NEXLIZET potentially gives us another important growth catalyst within 12 months. Turning now to CLOZARIL in Canada, our national patient base has now grown for five consecutive months through July, and that growth is broad-based. Ontario posted sequential gains in each of those months, and in Western Canada, we saw double-digit patient growth in British Columbia versus last year, and growth rates accelerating in both Alberta and Saskatchewan. The fundamentals are intact. Brian WalshCCO at HLS Therapeutics00:12:12The brand continues to hold about a 50% market share, and CLOZARIL remains a strong, stable cash contributor. For CLOZARIL in the U.S., as Craig noted, the year-over-year decline primarily reflects a comparably large Q2 last year. The timing of the July 4th holiday last year pulled some ordering into June, contributing to the outsized comparable. This remains a high-margin, cash-generating business, and we continue to look for ways to maintain patient volumes and expand the specialty pharmacy program. With that, I'll turn it over to John for a detailed look at our financials. John? John HannaCFO at HLS Therapeutics00:12:52Thank you, Brian, and good morning, everyone. In my section, I'll review Q2 results, the balance sheet, and our capital allocation priorities. My comments are all in U.S. dollars as per our reported numbers, unless otherwise noted. Starting with revenue, total revenue for Q2 was $14.7 million, up 3.5% from Q2 last year and up 2.8% year-to-date. The increase was driven by our CV portfolio which, as Craig mentioned, grew 25% in Q2 in local currency, reflecting continued growth in Vascepa and the first full quarter of net sales from NILEMDO. CLOZARIL net sales in Canada were down just 1% in local currency versus Q2 last year, a significant improvement from Q1 comparables. John HannaCFO at HLS Therapeutics00:13:47CLOZARIL net sales in the U.S. were $3 million compared to $3.5 million in Q2 last year and were impacted by the factors discussed by Craig and Brian earlier. Finally, royalty revenue was $205,000 in Q2, compared to $148,000 in Q2 last year. Cost of sales in Q2 was up 14% compared to Q2 last year and up 13% year-to-date, with the increases due to demand growth in Vascepa and initial sales of NILEMDO. On the expense side, Q2 operating expenses, comprising sales and marketing, medical, regulatory, and patient support, as well as G&A, were $7.2 million, up 10% compared to Q2 last year. Year-to-date operating expenses were up 8%. The increases reflect our investment in NILEMDO launch. Q2 Adjusted EBITDA was $4.7 million compared to $5.2 million in Q2 last year. John HannaCFO at HLS Therapeutics00:14:54Adjusted EBITDA was impacted by the NILEMDO launch investment as just described. As we have discussed, we expect margins to improve for the second half of the year as NILEMDO revenue ramps. There is generally seasonal variation by quarter in Adjusted EBITDA, as those of you on the webcast can see on this slide. We expect a similar pattern in 2026, with a first-half dip followed by improving Adjusted EBITDA in the second half. Looking past the quarterly variation, since 2024, Adjusted EBITDA margin, excluding royalty revenue on a trailing 12-month basis, has increased from 20% to 32%. This reflects the operational improvements we've made, as well as growth in our CV portfolio. For Q2, the direct brand contribution from CLOZARIL to Adjusted EBITDA was $6.7 million. For the year-to-date period, the direct brand contribution was $12.4 million. John HannaCFO at HLS Therapeutics00:15:57Turning to the cardiovascular portfolio, even with additional launch expenses, the direct brand contribution was break even in both the Q2 and year-to-date periods. Cash from operations in Q2 was $2.9 million compared to $4.6 million in Q2 last year, while year-to-date cash from operations was $9.3 million compared to $8.1 million, up 14%. The year-to-date increase reflects the operational improvements made over the last two years, along with significantly lower interest expense. Interest was $1.3 million year-to-date compared to $3.1 million in the same period last year, the result of our 2025 credit agreement and a lower debt balance overall. This next slide highlights our cash generation. We can start by taking Adjusted EBITDA as a useful proxy for cash flow over time. John HannaCFO at HLS Therapeutics00:16:53From that, we first deduct royalty revenue, which is not core to our ongoing business, and then deduct net interest paid. What is left, shown in the bars, is a view of the capital we have available to allocate on a trailing 12-month basis. Excluding royalty matters here, because at the start of this period, royalties were contributing more than $9 million a year to Adjusted EBITDA. The dotted line shows trailing 12-month interest paid over the same period. Two things are happening at once. Our net interest paid has fallen from as high as $8.8 million in 2024 to $3.2 million, reflecting the debt we have repaid and the improved terms of our 2025 credit agreement. At the same time, we stripped out considerable sales and marketing expense while still growing the underlying business. John HannaCFO at HLS Therapeutics00:17:46Put that all together, and what the core business generates after servicing interest on our debt has grown from $2.3 million at the beginning of 2024 to $14.7 million at the end of Q2 this year. That combination is funding the capital priorities I will turn to next. As Craig outlined, with the balance sheet work largely complete, our capital allocation priorities have shifted. Let me take each in turn. First, investing in growth. We have the flexibility to pursue business development opportunities that meet the goals Craig outlined earlier, and we are well-positioned to act when the right opportunity presents itself. Second, returning capital to shareholders. In June, we launched a Normal Course Issuer Bid, allowing us to purchase up to 1.5 million common shares. We have been active purchasers under the bid since inception. John HannaCFO at HLS Therapeutics00:18:42Through to July 31st, we have repurchased approximately 340,000 shares, returning CAD 1.4 million to shareholders. We believe our shares represent compelling value at current prices, and the NCIB provides a flexible vehicle for returning capital as our cash flow allows. Third, on debt, the heavy lifting of delevering is behind us. In Q2, we made a principal repayment of $1.1 million. At June 30th, 2026, the principal balance on our term loan stood at $42.2 million, down 16% from the end of 2025. Net debt stood at $28.5 million, down 26% from the end of 2025. Taken together, our leverage ratio has declined significantly over the past two years. This is the strongest balance sheet position we have been in for years and is what gives us the flexibility Craig described. John HannaCFO at HLS Therapeutics00:19:39Going forward, debt will continue to decline through scheduled amortization, with any additional payments made at our discretion. Finally, looking at balance sheet, cash was $13.7 million at quarter end, up from $11.7 million at the end of 2025. I would note that provisions rose to $14.6 million at the end of Q2. As a reminder, one of our largest provincial rebates settles only once a year, typically in Q3, so we see a cyclical trend whereby provisions rise for three quarters and then drop back when the annual rebate is settled. In summary, the business is generating cash to fund both of our capital priorities simultaneously while debt continues to decline through scheduled prepayments. We are well-positioned to act on the right business development opportunities as they arise. With that, I will pass it back to Craig for his closing comments. Craig MillianCEO at HLS Therapeutics00:20:33Thanks, John. Before we open it up to Q&A, three quick thoughts on the quarter and where we are headed. First, HLS is a fundamentally stronger company than at any time in my tenure. The delevering work we set out to do is largely accomplished. We have our strongest balance sheet in years, and with consistent cash generation, we have begun returning capital to shareholders through a buyback. Second, the growth engine is starting to deliver. The cardiovascular portfolio grew approximately 25% this quarter. Vascepa is sustaining double-digit growth. NILEMDO is ahead of plan with payer coverage expanding. In Canada, the CLOZARIL patient base is growing once again. Third, several catalysts are ahead of us. Private coverage for NILEMDO continues to ramp. With a favorable Canada's Drug Agency recommendation, we will begin to pursue public reimbursement. Craig MillianCEO at HLS Therapeutics00:21:32NEXLIZET remains on track for a Health Canada decision by year-end, followed by a first half 2027 launch. In addition, we have the resources to act on business development opportunities that fit our criteria. Our goal is to build scale in the coming years, both organically and through disciplined business development. This will increase operating leverage, broaden reach with our customers, and create greater value for shareholders. That concludes my prepared remarks, and we look forward to keeping you updated on our progress. At this point, I'll ask our operator to please provide instructions for asking a question. Operator00:22:11Thank you. Ladies and gentlemen, we will now begin the question and answer session. Should you have a question, please press the star followed by the one on your touch tone phone. You will hear a prompt that your hand has been raised. If you wish to decline from the polling process, please press star followed by the two. If you are using a speakerphone, please lift the handset before pressing any key. First question comes from Michael Freeman with Raymond James. Please go ahead. Michael FreemanEquity Research Analyst at Raymond James00:22:41Hey, good morning, Craig, John, Brian, and congratulations, Brian, on your new role. My first question here is on Vascepa. Really encouraged to see this return to growth. I wonder if you could describe any of the ingredients involved in this, and perhaps the contribution of sales inquiries into docs for the purpose of advertising or showing them NILEMDO, while also having Vascepa in the bag. Craig MillianCEO at HLS Therapeutics00:23:19Thanks, Michael, for the question. Brian, do you want to take that? Brian WalshCCO at HLS Therapeutics00:23:21Hi, Michael. Good morning. Thank you. Yeah, great question. I think credit to the team. A lot of enthusiasm behind the NILEMDO launch, but remaining focused on both products in the franchise. One of our hypotheses with expanding the franchise was it creates more time in front of the customers, and we are seeing that. I am seeing it firsthand and our managers are reporting that back, that creating more absolute time for Vascepa in their interactions with customers. Brian WalshCCO at HLS Therapeutics00:23:50The NILEMDO story has a very clear value proposition, and they can move through that in their details and create an opportunity to extend on the benefits of Vascepa for cardiovascular reduction. We have talked in the past about how these are really synergistic in that way and that we are talking largely to the same customers about a similar segment of patients in their practice. To the team, we are seeing that strengthening in Q2 and optimistic it continues through the rest of the year moving forward. Craig MillianCEO at HLS Therapeutics00:24:23Yeah, and just maybe to add one additional point, I would say we have done a lot of work over the last couple of years also kind of rebuilding the commercial organization. We have had some departures and some restructuring over the past couple of years, and I think the strength of our portfolio in bringing in new assets has really made, I think, HLS a desired destination for a lot of really strong talent. So we have been able to recruit both at the sales rep level, at the manager level, really experienced, talented professionals with extensive experience and relationships in cardiovascular. So I think the team is as strong as it has ever been right now. Michael FreemanEquity Research Analyst at Raymond James00:25:07Great. All right, thanks very much for that. Now, looking at the guidance, it looks like there is an implied acceleration in second half EBITDA. I wonder if you could help build the bridge from here to there, talk about the growth drivers of that second half strength. Craig MillianCEO at HLS Therapeutics00:25:30Sure. I will start, and then maybe John, if I miss anything, maybe you can weigh in. I think, obviously, we just had our first full quarter of NILEMDO in Q2, and we expect, as Brian said, we are really encouraged by the week-over-week growth in ex-factory sales. Now with private payer coverage in many respects just hitting at the end of Q2 or into Q3, we have no reason to expect that acceleration not to continue. I think generally, we are holding the line on the expense side, and we expect to see some nice growth and continued growth and accelerated growth, quite frankly, on the cardiovascular side, driven in large part by the NILEMDO ramp. We expect to continue to see the growth in Vascepa that we have seen in the first half of the year. Craig MillianCEO at HLS Therapeutics00:26:23We are really encouraged, Michael, by the sequential growth in patients on the CLOZARIL side, which suggests that, and as we predicted, as the year goes by, we will see increasing stabilization on the CLOZARIL side as well. I think essentially managing our costs responsibly, which is what we, I think, have a pretty good track record of doing, and now starting to see that ramp in the top line we think will deliver improved margins in the back half of the year. John, I do not know if you have anything to add there. John HannaCFO at HLS Therapeutics00:27:00No, I think that is right. In the back half of the year as compared to the first two quarters, there will be a small decrease in the OpEx as compared to the second half to the first half, but primarily driven by what Craig had already outlined. Michael FreemanEquity Research Analyst at Raymond James00:27:23Okay. All right. Thank you very much. Congrats on the quarter. I am going to pass it on. Craig MillianCEO at HLS Therapeutics00:27:28Thanks. Brian WalshCCO at HLS Therapeutics00:27:28Thanks, Michael. John HannaCFO at HLS Therapeutics00:27:29Michael. Operator00:27:30Thank you. Next question comes from Max Chmielewski with Stifel. Please go ahead. Max ChmielewskiAnalyst at Stifel00:27:37Good morning, everyone. This is Max on for Justin. Nice quarter. Just the first question on CLOZARIL. I understand CSAN has historically been a pretty important tool in defending market share from generics. Can you maybe qualify what dynamics you're seeing more recently at the prescriber level as it relates to CSAN? Brian WalshCCO at HLS Therapeutics00:28:02Yeah. Hi, Max. Good morning. This is Brian Walsh. Thanks for the question. Yeah, we're seeing, as you said, CSAN is an important differentiator for the Canadian business, Health Canada mandated registry. Where we've seen across the country the differentiation play out, we've described previously some disruptions in Ontario, more from GPO contracts. But as a result of CSAN, the services we provide, the Pronto device that's integrated as part of that program, we've seen large numbers of patients move to pharmacies where they can get branded CLOZARIL, move to different ways to stay on the brand, and that's driven by the support that community physicians have for brand over generic because of the services and the device. Likewise, a lot of the growth in the West is driven by market share gains within the clozapine, so taking share from generics largely because of that service. Brian WalshCCO at HLS Therapeutics00:29:00We've had smaller whole account conversions in the West in Q2, which sets up encouraging for the rest of the year as well. Those are driven by the efforts of our team and the services that we provide on behalf of patients, again, with the device is an important part of that. Craig MillianCEO at HLS Therapeutics00:29:19We find patients are incredibly sticky unless they're forced to switch, which typically they're not, except in rare cases. For example, in Quebec, we've had a really strong retention rate, and part of that is based on the resources we've brought to bear in our customer-facing model, our go-to-market model, which provides a high level of support, as well as the preference for the Pronto device in many cases, as well as the, again, the high touch that CSAN provides. So, we think the suite of services that we provide around branded CLOZARIL has enabled us to maintain a very stable market share over extended periods of time and certainly allowed us to weather some of these temporary disruptions that happen from time to time. Max ChmielewskiAnalyst at Stifel00:30:21That's great. Thank you. Switching gears, can you maybe describe the current status of payer mix for Vascepa and what growth you've seen in the public channel sales versus the last few quarters? Craig MillianCEO at HLS Therapeutics00:30:35John, do you want to take that question? John HannaCFO at HLS Therapeutics00:30:38Yeah, I would say the public share as we exited the last couple of quarters of 2025 was in the just shade over 50% range. As we've progressed and seen some growth in 2026, we're moving up towards the 55% range. Probably through the year, we'll stay in that high end of the 50%-55% range. Craig MillianCEO at HLS Therapeutics00:31:13Yeah, I would add that the rate of growth on the public side relative to private has slowed considerably. We are seeing much greater stability in terms of payer mix in those provinces where we've been on public listings for a longer period of time. For example, Ontario and Quebec have become quite stable, which is good for us to be able to really predict our gross-to-net. Where we've seen some continued expansion on the public side, which is, as we expected, is the provinces where we were more recently listed, those being British Columbia and Alberta, where I think we've only been on listings for the last couple of years. Craig MillianCEO at HLS Therapeutics00:32:00The good news is, we are now, as predicted, starting to see that stabilization. I think we had expected to flatten out at about 50/50. I think as John said, we're probably a shade beyond that, but still within range. Max ChmielewskiAnalyst at Stifel00:32:18Great. Thank you. Just one last question. $13 million, almost $14 million in cash at the end of the quarter. As I understand it, somewhere in the range of $30 million in revolving capacity. So the balance sheet's been meaningfully improved. So well done on that front. As you focus on the NILEMDO launch, do you anticipate maybe a reduced focus on business development? As a follow-up to that, with the investments you've recently made on NILEMDO, how would you expect the commercial infrastructure to need to look like with the addition of additional products within cardiovascular? Craig MillianCEO at HLS Therapeutics00:32:57Yeah, that's a good question. I think our focus first of all is executing with our core assets, no question. That's job one. In parallel, we think we have the capacity to continue to be disciplined and thoughtful in terms of how we approach business development. We are looking at. We continue to screen assets very actively and look at a lot of stuff, and they have to meet our criteria of what is sensible for us to add at this stage of our evolution. We think there are attractive assets out there. I think a good example is the deal we did with Esperion on the bempedoic acid assets. Craig MillianCEO at HLS Therapeutics00:33:42Wherever possible, we strive to leverage the infrastructure we've built in Canada, both on the cardiovascular side and on the neuropsych side, and I think even more broadly, the capabilities we have, for example, in patient support services, which in many ways are transferable across multiple high touch therapeutic areas. We think we've got capacity. I think on a case-by-case basis, we'll evaluate the return on investment of an expansion of infrastructure. Certainly there may come a time where for example, in cardiovascular, if we wanted to move into different facets of cardiovascular, we might look to expand. But rest assured, it'll be well thought through and in a disciplined way, with an opportunity to very quickly generate a positive return. Max ChmielewskiAnalyst at Stifel00:34:41Wonderful. Thanks so much, guys. John HannaCFO at HLS Therapeutics00:34:47Thank you. Operator00:34:47Thank you. Next question comes from David Martin from Bloom Burton. Please go ahead. David MartinAnalyst at Bloom Burton00:34:52Good morning. When Vascepa was first launched, if I recall correctly, a material proportion of doctors waited to prescribe the drug until there was coverage for all patients. In other words, their privately insured patients, they didn't prescribe for them until public reimbursement was in place. Do you expect the same with NILEMDO? Brian WalshCCO at HLS Therapeutics00:35:20Hi, David. Good morning. This is Brian. It's not an either/or. Obviously, with public reimbursement, it just creates a wide-open access picture and makes it much easier for physicians to prescribe. I wouldn't say physicians intentionally wait, but it becomes just more nuanced for them to find those public patients. There's private patients in their practice. That's the work that our teams do with them to help identify the support we provide to our assistance program. But no question, now we have a message of very broad private access so physicians can identify at that level, and there's really not a lot of nuance on the surface for us on the private side where we're landed with pretty broad coverage and no restrictions, essentially. We're excited for that catalyst. We see it going into Q3 to accelerate, as Craig mentioned. Brian WalshCCO at HLS Therapeutics00:36:13As we go into next year, we expect to achieve public listings, and that will certainly make those conversations and the prescribing even easier for physicians and lift both sides. Craig MillianCEO at HLS Therapeutics00:36:25Yeah, I think launching NILEMDO into this market, I think in a sense, there was almost more pent-up demand, because this truly fits an unmet need that exists within a very prevalent existing paradigm as it relates to reducing cardiovascular risk in patients at risk, requiring LDL reduction and unable to get there with the current standard of care. We know there are a lot of those patients out there. This is a product that I think many of our physicians that we call them were eagerly anticipating this launch, and I think that bears out in terms of the pretty rapid uptake that Brian described on new-to-brand. I think Vascepa required a little bit more, and I talked about this in earlier calls, a little bit more category building, so to speak, because it really is very unique in terms of what it does. Craig MillianCEO at HLS Therapeutics00:37:27That required, in some respects, a little bit more education in terms of exactly how to fit that in. That is why I think we continue to see progress with Vascepa even many years in, because I think the data are so robust, but it is also we are creating a treatment paradigm with Vascepa that frankly already existed in a sense with bempedoic acid. David MartinAnalyst at Bloom Burton00:37:51When you say no restrictions, I know Vascepa has significant restrictions on the public payer side of things. Is that differentiated on the private payer side? In other words, did Vascepa with private payers have restrictions that you are not seeing with NILEMDO? Brian WalshCCO at HLS Therapeutics00:38:10Yeah, exactly, Dave. We estimate about half the patients on Vascepa, through our private coverage, have a prior authorization to conform to the various criteria. We, at this point, with the private access we have achieved with NILEMDO, that 80% is without the need for prior authorization. Physicians know it is a full benefit, and physicians can prescribe it without the need to do paperwork. The vast majority of patients should be able to go to the pharmacy and fill a script, where half the patients with Vascepa would need to go through some paperwork process, which we support through our assistance program. But it is a barrier, it takes time, and the physicians are busy. It just creates a bit of that element of a bit of a barrier. David MartinAnalyst at Bloom Burton00:39:01Great. Last question, if I can. The 300,000+ of NILEMDO sales, how much of that do you think was stocking in the channel? Should we expect a dip in the second quarter as- Brian WalshCCO at HLS Therapeutics00:39:18No David MartinAnalyst at Bloom Burton00:39:18initial Brian WalshCCO at HLS Therapeutics00:39:20No, we see continued growth into the quarter. The channel build stays on-hand, so as we grow, they will continue to hold more. We are seeing this through the IQVIA data. We are seeing the pull-through from actual prescriptions, the new-to-brand patients. The algorithms are pretty sophisticated at this point with the wholesalers and last mile to patient to the next day. So they are not holding a lot of inventory. We are seeing this being demand-driven. Craig MillianCEO at HLS Therapeutics00:39:51Yeah, there was no heavy initial stocking. As Brian says, the stocking builds as the demand grows and the days on hand tend to be consistent. So, we continue to see on a weekly basis, increases in orders. In other words, our weekly run rate in July certainly is better than June, better than in May, and now we have not even yet been able to really activate our teams around some of the new access wins that we have. So we are looking at our internal forecast in general and raising them around NILEMDO. We expect third quarter to be much stronger than second quarter and then growing momentum as we head into 2027. David MartinAnalyst at Bloom Burton00:40:42Okay, thanks. That is it for me. Brian WalshCCO at HLS Therapeutics00:40:45Thanks, Dave. Operator00:40:48Thank you. The next question comes from Christopher Pugh with Canaccord. Please go ahead. Christopher PughAnalyst at Canaccord00:40:55Hey, good morning. Yeah, thanks for taking my question. I am on the line for Tania right now. Considering it is still early, but I am interested to hear on perhaps, are you seeing any cross-selling synergy with Vascepa for NILEMDO? Are the sales force leveraging existing relationships with the specialists to drive the trial of NILEMDO and any trends on perhaps through prescriptions? Brian WalshCCO at HLS Therapeutics00:41:26Sure. This is Brian. Thanks for the question. Exactly, and that is one of our key drivers for this deal was the synergy essentially at the base of the customer between Vascepa and the bempedoic acid franchise. It is almost a complete overlap with the call point, the same customer base. So we are seeing exactly that synergy you described. With Vascepa, any product where you are going into year six or seven, it is a little bit more difficult to bring new information. Our teams do the best they every day to do that and support patients. But bringing something new, exciting, creates an opportunity for more time in front of the customer. Brian WalshCCO at HLS Therapeutics00:42:08What I have seen and what our teams have reported is the NILEMDO story is straightforward. It fits a very established unmet need, as Craig described. We have created an access milieu which is very efficient and easy. It's creating more time for Vascepa. As we went through the quarter, Q2, despite the loss in NILEMDO, we saw acceleration in new-to-brand patients for Vascepa, and we've seen that strong year-over-year growth. So those hypotheses are playing out that we have a strong foundation as a franchise to build on, and we're excited to do so with NEXLIZET going into 2027 as well. Christopher PughAnalyst at Canaccord00:42:53That's great to hear. I just got one last question regarding the expenses. You mentioned that you're holding the line on the expense side. So would it be fair to say that the Q2 was perhaps peak spend on the S&M for NILEMDO? Craig MillianCEO at HLS Therapeutics00:43:13Just- John HannaCFO at HLS Therapeutics00:43:13I think that is- Craig MillianCEO at HLS Therapeutics00:43:14Go ahead, John. John HannaCFO at HLS Therapeutics00:43:16Yeah, I think that is fair to say that it's likely the peak of the four quarters. Craig MillianCEO at HLS Therapeutics00:43:24Yeah, I would say, we do a lot of dynamic budgeting at HLS, so we're always looking at where we can generate the best return on any dollar we spend. We look across the entire portfolio, so it may very well be where we're generating growth with NILEMDO. We might increase some investment there, but we'll look at other areas that we might be able to find some savings. That's a dynamic process. But on net, we're looking obviously to make sure we're maintaining our profitability, as John mentioned. Christopher PughAnalyst at Canaccord00:44:02Okay, that's it for me. Thanks. Craig MillianCEO at HLS Therapeutics00:44:05Thank you. Operator00:44:08Thank you. We have no further questions, and we will turn the call back over to Craig Millian for closing comments. Craig MillianCEO at HLS Therapeutics00:44:13Great. Thank you. Thank you all for participating on today's call. We look forward to reporting to you on our progress in the coming quarters and speaking with you again soon. Bye. Goodbye, and have a great afternoon. Operator00:44:27Ladies and gentlemen, this concludes your conference call for today. We thank you for participating, and we ask that you please disconnect your lines.Read moreParticipantsExecutivesDave MasonInvestor RelationsCraig MillianCEOBrian WalshCCOJohn HannaCFOAnalystsMichael FreemanEquity Research Analyst at Raymond JamesMax ChmielewskiAnalyst at StifelDavid MartinAnalyst at Bloom BurtonChristopher PughAnalyst at CanaccordPowered by Earnings DocumentsSlide DeckPress Release HLS Therapeutics Earnings HeadlinesHLS Therapeutics (TSE:HLS) Upgraded at Raymond James FinancialAugust 17 at 1:24 AM | americanbankingnews.comHLS Therapeutics (TSE:HLS) Stock Rating Upgraded by Canaccord Genuity GroupAugust 15, 2026 | americanbankingnews.comThe REAL Reason Trump is Invading IranFor a moment… Forget about Trump’s ties to Israel. Forget about reports of Iran’s nuclear program. Because my research has led me to believe we’re risking World War 3 with Iran for a completely different reason.August 19 at 1:00 AM | Banyan Hill Publishing (Ad)HLS Therapeutics Inc.August 6, 2026 | barrons.comHLS Therapeutics to Host Q2 2026 Financial Results Conference CallJuly 30, 2026 | finance.yahoo.comHLS:CA HLS Therapeutics Inc.July 28, 2026 | seekingalpha.comSee More HLS Therapeutics Headlines Get Earnings Announcements in your inboxWant to stay updated on the latest earnings announcements and upcoming reports for companies like HLS Therapeutics? Sign up for Earnings360's daily newsletter to receive timely earnings updates on HLS Therapeutics and other key companies, straight to your email. Email Address About HLS TherapeuticsHLS Therapeutics (TSE:HLS) Inc is a specialty pharmaceutical company. It is focused on the acquisition and commercialization of branded pharmaceutical products in the North American markets. The company is focused on treatment products for the central nervous system (CNS), and cardiovascular specialties. The company products include Clozaril, Absorica, Vascepa, CSAN Pronto, Trinomia and Perseris. The company earns revenue in the form of product sales and royalties, out of which product sales contribute to the majority of the revenue. 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PresentationSkip to Participants Operator00:00:00Good morning, and welcome to the second quarter fiscal 2026 financial results conference call for HLS Therapeutics. At this point, I would like to turn the call over to Dave Mason, Investor Relations, for the introductory remarks. Please go ahead. Dave MasonInvestor Relations at HLS Therapeutics00:00:15Good morning, everyone, and thank you for joining us today. With me on the call are Craig Millian, Chief Executive Officer, John Hanna, Chief Financial Officer, and Brian Walsh, Chief Operating Officer. Earlier this morning, we issued a news release announcing our financial results for the three and six months ended June 30, 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. Dave MasonInvestor Relations at HLS Therapeutics00:01:16Risk 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 USD, unless otherwise specified. I would now like to turn the meeting over to Mr. Millian. Please go ahead. Craig MillianCEO at HLS Therapeutics00:01:56Thanks, Dave. Good morning, everyone, and thank you for joining us today. On our call today, I'll take you through our second quarter performance along with a corporate update. Brian will then follow with a closer look at each of our products. John will cover the financials in detail. I'll be back with a few closing thoughts before we open it up for questions. Starting with the big picture. The story of this quarter is the acceleration of our cardiovascular growth engine. Our cardiovascular portfolio delivered second quarter net sales growth of 25% year-over-year, driven by double-digit Vascepa growth along with a strong first quarter of sales for newly launched NILEMDO. At the same time, our CLOZARIL patient base in Canada has grown sequentially for five consecutive months, including July. This is a positive sign that business is stabilizing. Craig MillianCEO at HLS Therapeutics00:02:54HLS is consistently generating cash, and with the strongest balance sheet in many years, we can invest in growing the company while also returning capital to shareholders. Now let's briefly review the second quarter financial highlights. Starting with the top line. Revenue in Q2 was $14.7 million, up 3.5% year-over-year. The cardiovascular portfolio led the way with a 25% increase in net sales in both local and reporting currency. Vascepa net sales grew 18%, which was a slight improvement over the strong growth it had in the first quarter. NILEMDO, in its first full quarter on the market, generated over $300,000 in net sales. This is slightly ahead of our forecast and particularly encouraging in that meaningful private payer coverage only started to take effect late in the quarter. Craig MillianCEO at HLS Therapeutics00:03:52In addition, as we announced last week, NILEMDO has now secured reimbursement with the largest private payers in Canada and achieved the unanimous recommendation for public reimbursement from Canada's Drug Agency. Brian will take you through greater detail on the NILEMDO launch and the near-term catalysts on the horizon. Turning to CLOZARIL. In Canada, the trend we highlighted last quarter continued, with consistent monthly gains in the base of patients on branded CLOZARIL. Net sales were down just 1% versus the second quarter of last year in both local and reporting currency, a further positive sign that the business is stabilizing. In the U.S., Q2 CLOZARIL net sales were down versus the prior year and are down about $600,000 year to date. Craig MillianCEO at HLS Therapeutics00:04:46This is in part due to a slight decrease in demand, but also reflected a challenging year-over-year comparison as the second quarter of last year accounted for 28% of full-year U.S. CLOZARIL sales. We expect a relatively flat year-over-year sales comparison for U.S. CLOZARIL for the second half of 2026. Adjusted EBITDA for the quarter was $4.7 million, about 10% less than prior year, similar to the Q1 decline, and in line with our expectations related to the incremental first half launch investment in NILEMDO. As we're now seeing the expected uptick in revenue growth driven by the NILEMDO launch, we expect margin expansion for our cardiovascular portfolio in the coming quarters. Even with the incremental investment to launch NILEMDO, and with only one full quarter of sales, the direct brand contribution from our cardiovascular portfolio is breakeven for the year. That brings me to capital allocation. Craig MillianCEO at HLS Therapeutics00:05:54Over the past couple years, we set out to put HLS on a stronger financial footing, and that work is largely done. We have successfully delevered the balance sheet, reduced our interest costs and built a business that is now consistently generating significant cash flow. Cash from operations is up 14% year-to-date, which reflects the operational improvements made over the past two years. With that foundation in place, our capital priorities have shifted to responsibly investing in new growth opportunities and returning capital to shareholders. In June, we launched a Normal Course Issuer Bid for up to 1.5 million shares and have been active buyers since. On the growth side, we continue to pursue business development opportunities that are consistent with our strategic focus, organizational capabilities, and financial resources. Craig MillianCEO at HLS Therapeutics00:06:52HLS is highly regarded as a potential partner in Canada based on our capabilities and customer relationships in specialty therapeutic areas. Our intent is to bring in assets at a reasonable cost that can meaningfully grow the top line, are accretive in the near term, and allow us to more fully leverage the infrastructure we've built in Canadian specialty markets. With our balance sheet in great shape, we will remain disciplined in our approach with the capacity to act when attractive opportunities present themselves. Moving to guidance, we are reaffirming our 2026 outlook. Revenue of $56 million to $60 million and Adjusted EBITDA of $18.5 million to $21 million. Consistent with the quarterly gating we outlined last quarter, we expect year-over-year Adjusted EBITDA comps to improve in the second half of the year as the cardiovascular portfolio revenue continues to ramp. Craig MillianCEO at HLS Therapeutics00:07:54With that, let me hand things over to Brian. Before I do, you may have noticed in Dave's introduction that Brian is now our Chief Operating Officer. Brian has been an impactful leader since joining HLS three years ago as Chief Commercial Officer. In his expanded role, Brian will continue to lead our commercial organization and will also oversee our field medical and patient support functions, creating even stronger alignment at the field and customer level. Brian, over to you. Brian WalshCCO at HLS Therapeutics00:08:24Thanks, Craig. Good morning, everyone. I'll take you through the portfolio this morning, starting with our cardiovascular growth drivers, Vascepa and NILEMDO, then CLOZARIL in Canada and the U.S. Starting with Vascepa, net sales grew 18% in Q2 year-over-year, and units grew 16%. Year-to-date, net sales grew 14% and units grew 17%. That's our second consecutive quarter of double-digit growth, reflecting the changes we made to the cardiovascular sales team in 2025. Prescriber breadth and depth both continue to track positively, meaning we are expanding a writer base, not just deepening it, and payer mix remains stable, supporting brand profitability. With patent protection through the late 2030s, Vascepa remains a durable growth driver in its seventh year on the market and will become an increasingly meaningful contributor to margin going forward. Now to NILEMDO, which completed its first full quarter on the market. Brian WalshCCO at HLS Therapeutics00:09:26Net sales were ahead of forecast, with wholesaler reorders continuing and the weekly ex-factory run rate strengthening as the quarter progressed. I've shared previously the enthusiasm that prescribers across Canada have shown for NILEMDO. Many reported having created lists of their patients that they've pre-identified for this therapy. In Q2, we witnessed this excitement translate to action, where at the end of Q2, prescribers had started nearly 1,200 new patients on NILEMDO, as measured by new-to-brand RX, or NBRX. For comparison, this is about 3.5 times greater than where Vascepa was at the same point in its launch. What makes these early results especially encouraging is that most of the quarter was ahead of the full private coverage now coming into effect in Q3. On that front, private payer access is running ahead of our plan. Brian WalshCCO at HLS Therapeutics00:10:19As we announced on August 5th, we have now secured reimbursement with the largest private payers in Canada, representing approximately 80% of privately insured Canadians. The vast majority of these patients can now access NILEMDO as a full benefit without restrictions. Several of these agreements are already in effect, with the remainder taking effect during the third quarter. On the public side, also announced, Canada's Drug Agency has finalized its reimbursement recommendation for NILEMDO, with its expert committee voting unanimously to recommend reimbursement by participating public drug plans. This opens the window for us to begin negotiations with the pan-Canadian Pharmaceutical Alliance for product listing agreements. We intend to commence these negotiations later this year, keeping us on track for initial provincial listings in the first half of 2027. Brian WalshCCO at HLS Therapeutics00:11:11On NEXLIZET, the fixed-dose combination, we remain on track for a Health Canada decision by year-end, with launch to follow in the first half of 2027. As we have described, NILEMDO is a differentiated new entity, bempedoic acid, and it establishes the foundation. Once approved, NEXLIZET, which combines bempedoic acid with a commonly used lipid-lowering drug, ezetimibe, will bring the combined benefits of both medicines to patients in one daily pill. NEXLIZET potentially gives us another important growth catalyst within 12 months. Turning now to CLOZARIL in Canada, our national patient base has now grown for five consecutive months through July, and that growth is broad-based. Ontario posted sequential gains in each of those months, and in Western Canada, we saw double-digit patient growth in British Columbia versus last year, and growth rates accelerating in both Alberta and Saskatchewan. The fundamentals are intact. Brian WalshCCO at HLS Therapeutics00:12:12The brand continues to hold about a 50% market share, and CLOZARIL remains a strong, stable cash contributor. For CLOZARIL in the U.S., as Craig noted, the year-over-year decline primarily reflects a comparably large Q2 last year. The timing of the July 4th holiday last year pulled some ordering into June, contributing to the outsized comparable. This remains a high-margin, cash-generating business, and we continue to look for ways to maintain patient volumes and expand the specialty pharmacy program. With that, I'll turn it over to John for a detailed look at our financials. John? John HannaCFO at HLS Therapeutics00:12:52Thank you, Brian, and good morning, everyone. In my section, I'll review Q2 results, the balance sheet, and our capital allocation priorities. My comments are all in U.S. dollars as per our reported numbers, unless otherwise noted. Starting with revenue, total revenue for Q2 was $14.7 million, up 3.5% from Q2 last year and up 2.8% year-to-date. The increase was driven by our CV portfolio which, as Craig mentioned, grew 25% in Q2 in local currency, reflecting continued growth in Vascepa and the first full quarter of net sales from NILEMDO. CLOZARIL net sales in Canada were down just 1% in local currency versus Q2 last year, a significant improvement from Q1 comparables. John HannaCFO at HLS Therapeutics00:13:47CLOZARIL net sales in the U.S. were $3 million compared to $3.5 million in Q2 last year and were impacted by the factors discussed by Craig and Brian earlier. Finally, royalty revenue was $205,000 in Q2, compared to $148,000 in Q2 last year. Cost of sales in Q2 was up 14% compared to Q2 last year and up 13% year-to-date, with the increases due to demand growth in Vascepa and initial sales of NILEMDO. On the expense side, Q2 operating expenses, comprising sales and marketing, medical, regulatory, and patient support, as well as G&A, were $7.2 million, up 10% compared to Q2 last year. Year-to-date operating expenses were up 8%. The increases reflect our investment in NILEMDO launch. Q2 Adjusted EBITDA was $4.7 million compared to $5.2 million in Q2 last year. John HannaCFO at HLS Therapeutics00:14:54Adjusted EBITDA was impacted by the NILEMDO launch investment as just described. As we have discussed, we expect margins to improve for the second half of the year as NILEMDO revenue ramps. There is generally seasonal variation by quarter in Adjusted EBITDA, as those of you on the webcast can see on this slide. We expect a similar pattern in 2026, with a first-half dip followed by improving Adjusted EBITDA in the second half. Looking past the quarterly variation, since 2024, Adjusted EBITDA margin, excluding royalty revenue on a trailing 12-month basis, has increased from 20% to 32%. This reflects the operational improvements we've made, as well as growth in our CV portfolio. For Q2, the direct brand contribution from CLOZARIL to Adjusted EBITDA was $6.7 million. For the year-to-date period, the direct brand contribution was $12.4 million. John HannaCFO at HLS Therapeutics00:15:57Turning to the cardiovascular portfolio, even with additional launch expenses, the direct brand contribution was break even in both the Q2 and year-to-date periods. Cash from operations in Q2 was $2.9 million compared to $4.6 million in Q2 last year, while year-to-date cash from operations was $9.3 million compared to $8.1 million, up 14%. The year-to-date increase reflects the operational improvements made over the last two years, along with significantly lower interest expense. Interest was $1.3 million year-to-date compared to $3.1 million in the same period last year, the result of our 2025 credit agreement and a lower debt balance overall. This next slide highlights our cash generation. We can start by taking Adjusted EBITDA as a useful proxy for cash flow over time. John HannaCFO at HLS Therapeutics00:16:53From that, we first deduct royalty revenue, which is not core to our ongoing business, and then deduct net interest paid. What is left, shown in the bars, is a view of the capital we have available to allocate on a trailing 12-month basis. Excluding royalty matters here, because at the start of this period, royalties were contributing more than $9 million a year to Adjusted EBITDA. The dotted line shows trailing 12-month interest paid over the same period. Two things are happening at once. Our net interest paid has fallen from as high as $8.8 million in 2024 to $3.2 million, reflecting the debt we have repaid and the improved terms of our 2025 credit agreement. At the same time, we stripped out considerable sales and marketing expense while still growing the underlying business. John HannaCFO at HLS Therapeutics00:17:46Put that all together, and what the core business generates after servicing interest on our debt has grown from $2.3 million at the beginning of 2024 to $14.7 million at the end of Q2 this year. That combination is funding the capital priorities I will turn to next. As Craig outlined, with the balance sheet work largely complete, our capital allocation priorities have shifted. Let me take each in turn. First, investing in growth. We have the flexibility to pursue business development opportunities that meet the goals Craig outlined earlier, and we are well-positioned to act when the right opportunity presents itself. Second, returning capital to shareholders. In June, we launched a Normal Course Issuer Bid, allowing us to purchase up to 1.5 million common shares. We have been active purchasers under the bid since inception. John HannaCFO at HLS Therapeutics00:18:42Through to July 31st, we have repurchased approximately 340,000 shares, returning CAD 1.4 million to shareholders. We believe our shares represent compelling value at current prices, and the NCIB provides a flexible vehicle for returning capital as our cash flow allows. Third, on debt, the heavy lifting of delevering is behind us. In Q2, we made a principal repayment of $1.1 million. At June 30th, 2026, the principal balance on our term loan stood at $42.2 million, down 16% from the end of 2025. Net debt stood at $28.5 million, down 26% from the end of 2025. Taken together, our leverage ratio has declined significantly over the past two years. This is the strongest balance sheet position we have been in for years and is what gives us the flexibility Craig described. John HannaCFO at HLS Therapeutics00:19:39Going forward, debt will continue to decline through scheduled amortization, with any additional payments made at our discretion. Finally, looking at balance sheet, cash was $13.7 million at quarter end, up from $11.7 million at the end of 2025. I would note that provisions rose to $14.6 million at the end of Q2. As a reminder, one of our largest provincial rebates settles only once a year, typically in Q3, so we see a cyclical trend whereby provisions rise for three quarters and then drop back when the annual rebate is settled. In summary, the business is generating cash to fund both of our capital priorities simultaneously while debt continues to decline through scheduled prepayments. We are well-positioned to act on the right business development opportunities as they arise. With that, I will pass it back to Craig for his closing comments. Craig MillianCEO at HLS Therapeutics00:20:33Thanks, John. Before we open it up to Q&A, three quick thoughts on the quarter and where we are headed. First, HLS is a fundamentally stronger company than at any time in my tenure. The delevering work we set out to do is largely accomplished. We have our strongest balance sheet in years, and with consistent cash generation, we have begun returning capital to shareholders through a buyback. Second, the growth engine is starting to deliver. The cardiovascular portfolio grew approximately 25% this quarter. Vascepa is sustaining double-digit growth. NILEMDO is ahead of plan with payer coverage expanding. In Canada, the CLOZARIL patient base is growing once again. Third, several catalysts are ahead of us. Private coverage for NILEMDO continues to ramp. With a favorable Canada's Drug Agency recommendation, we will begin to pursue public reimbursement. Craig MillianCEO at HLS Therapeutics00:21:32NEXLIZET remains on track for a Health Canada decision by year-end, followed by a first half 2027 launch. In addition, we have the resources to act on business development opportunities that fit our criteria. Our goal is to build scale in the coming years, both organically and through disciplined business development. This will increase operating leverage, broaden reach with our customers, and create greater value for shareholders. That concludes my prepared remarks, and we look forward to keeping you updated on our progress. At this point, I'll ask our operator to please provide instructions for asking a question. Operator00:22:11Thank you. Ladies and gentlemen, we will now begin the question and answer session. Should you have a question, please press the star followed by the one on your touch tone phone. You will hear a prompt that your hand has been raised. If you wish to decline from the polling process, please press star followed by the two. If you are using a speakerphone, please lift the handset before pressing any key. First question comes from Michael Freeman with Raymond James. Please go ahead. Michael FreemanEquity Research Analyst at Raymond James00:22:41Hey, good morning, Craig, John, Brian, and congratulations, Brian, on your new role. My first question here is on Vascepa. Really encouraged to see this return to growth. I wonder if you could describe any of the ingredients involved in this, and perhaps the contribution of sales inquiries into docs for the purpose of advertising or showing them NILEMDO, while also having Vascepa in the bag. Craig MillianCEO at HLS Therapeutics00:23:19Thanks, Michael, for the question. Brian, do you want to take that? Brian WalshCCO at HLS Therapeutics00:23:21Hi, Michael. Good morning. Thank you. Yeah, great question. I think credit to the team. A lot of enthusiasm behind the NILEMDO launch, but remaining focused on both products in the franchise. One of our hypotheses with expanding the franchise was it creates more time in front of the customers, and we are seeing that. I am seeing it firsthand and our managers are reporting that back, that creating more absolute time for Vascepa in their interactions with customers. Brian WalshCCO at HLS Therapeutics00:23:50The NILEMDO story has a very clear value proposition, and they can move through that in their details and create an opportunity to extend on the benefits of Vascepa for cardiovascular reduction. We have talked in the past about how these are really synergistic in that way and that we are talking largely to the same customers about a similar segment of patients in their practice. To the team, we are seeing that strengthening in Q2 and optimistic it continues through the rest of the year moving forward. Craig MillianCEO at HLS Therapeutics00:24:23Yeah, and just maybe to add one additional point, I would say we have done a lot of work over the last couple of years also kind of rebuilding the commercial organization. We have had some departures and some restructuring over the past couple of years, and I think the strength of our portfolio in bringing in new assets has really made, I think, HLS a desired destination for a lot of really strong talent. So we have been able to recruit both at the sales rep level, at the manager level, really experienced, talented professionals with extensive experience and relationships in cardiovascular. So I think the team is as strong as it has ever been right now. Michael FreemanEquity Research Analyst at Raymond James00:25:07Great. All right, thanks very much for that. Now, looking at the guidance, it looks like there is an implied acceleration in second half EBITDA. I wonder if you could help build the bridge from here to there, talk about the growth drivers of that second half strength. Craig MillianCEO at HLS Therapeutics00:25:30Sure. I will start, and then maybe John, if I miss anything, maybe you can weigh in. I think, obviously, we just had our first full quarter of NILEMDO in Q2, and we expect, as Brian said, we are really encouraged by the week-over-week growth in ex-factory sales. Now with private payer coverage in many respects just hitting at the end of Q2 or into Q3, we have no reason to expect that acceleration not to continue. I think generally, we are holding the line on the expense side, and we expect to see some nice growth and continued growth and accelerated growth, quite frankly, on the cardiovascular side, driven in large part by the NILEMDO ramp. We expect to continue to see the growth in Vascepa that we have seen in the first half of the year. Craig MillianCEO at HLS Therapeutics00:26:23We are really encouraged, Michael, by the sequential growth in patients on the CLOZARIL side, which suggests that, and as we predicted, as the year goes by, we will see increasing stabilization on the CLOZARIL side as well. I think essentially managing our costs responsibly, which is what we, I think, have a pretty good track record of doing, and now starting to see that ramp in the top line we think will deliver improved margins in the back half of the year. John, I do not know if you have anything to add there. John HannaCFO at HLS Therapeutics00:27:00No, I think that is right. In the back half of the year as compared to the first two quarters, there will be a small decrease in the OpEx as compared to the second half to the first half, but primarily driven by what Craig had already outlined. Michael FreemanEquity Research Analyst at Raymond James00:27:23Okay. All right. Thank you very much. Congrats on the quarter. I am going to pass it on. Craig MillianCEO at HLS Therapeutics00:27:28Thanks. Brian WalshCCO at HLS Therapeutics00:27:28Thanks, Michael. John HannaCFO at HLS Therapeutics00:27:29Michael. Operator00:27:30Thank you. Next question comes from Max Chmielewski with Stifel. Please go ahead. Max ChmielewskiAnalyst at Stifel00:27:37Good morning, everyone. This is Max on for Justin. Nice quarter. Just the first question on CLOZARIL. I understand CSAN has historically been a pretty important tool in defending market share from generics. Can you maybe qualify what dynamics you're seeing more recently at the prescriber level as it relates to CSAN? Brian WalshCCO at HLS Therapeutics00:28:02Yeah. Hi, Max. Good morning. This is Brian Walsh. Thanks for the question. Yeah, we're seeing, as you said, CSAN is an important differentiator for the Canadian business, Health Canada mandated registry. Where we've seen across the country the differentiation play out, we've described previously some disruptions in Ontario, more from GPO contracts. But as a result of CSAN, the services we provide, the Pronto device that's integrated as part of that program, we've seen large numbers of patients move to pharmacies where they can get branded CLOZARIL, move to different ways to stay on the brand, and that's driven by the support that community physicians have for brand over generic because of the services and the device. Likewise, a lot of the growth in the West is driven by market share gains within the clozapine, so taking share from generics largely because of that service. Brian WalshCCO at HLS Therapeutics00:29:00We've had smaller whole account conversions in the West in Q2, which sets up encouraging for the rest of the year as well. Those are driven by the efforts of our team and the services that we provide on behalf of patients, again, with the device is an important part of that. Craig MillianCEO at HLS Therapeutics00:29:19We find patients are incredibly sticky unless they're forced to switch, which typically they're not, except in rare cases. For example, in Quebec, we've had a really strong retention rate, and part of that is based on the resources we've brought to bear in our customer-facing model, our go-to-market model, which provides a high level of support, as well as the preference for the Pronto device in many cases, as well as the, again, the high touch that CSAN provides. So, we think the suite of services that we provide around branded CLOZARIL has enabled us to maintain a very stable market share over extended periods of time and certainly allowed us to weather some of these temporary disruptions that happen from time to time. Max ChmielewskiAnalyst at Stifel00:30:21That's great. Thank you. Switching gears, can you maybe describe the current status of payer mix for Vascepa and what growth you've seen in the public channel sales versus the last few quarters? Craig MillianCEO at HLS Therapeutics00:30:35John, do you want to take that question? John HannaCFO at HLS Therapeutics00:30:38Yeah, I would say the public share as we exited the last couple of quarters of 2025 was in the just shade over 50% range. As we've progressed and seen some growth in 2026, we're moving up towards the 55% range. Probably through the year, we'll stay in that high end of the 50%-55% range. Craig MillianCEO at HLS Therapeutics00:31:13Yeah, I would add that the rate of growth on the public side relative to private has slowed considerably. We are seeing much greater stability in terms of payer mix in those provinces where we've been on public listings for a longer period of time. For example, Ontario and Quebec have become quite stable, which is good for us to be able to really predict our gross-to-net. Where we've seen some continued expansion on the public side, which is, as we expected, is the provinces where we were more recently listed, those being British Columbia and Alberta, where I think we've only been on listings for the last couple of years. Craig MillianCEO at HLS Therapeutics00:32:00The good news is, we are now, as predicted, starting to see that stabilization. I think we had expected to flatten out at about 50/50. I think as John said, we're probably a shade beyond that, but still within range. Max ChmielewskiAnalyst at Stifel00:32:18Great. Thank you. Just one last question. $13 million, almost $14 million in cash at the end of the quarter. As I understand it, somewhere in the range of $30 million in revolving capacity. So the balance sheet's been meaningfully improved. So well done on that front. As you focus on the NILEMDO launch, do you anticipate maybe a reduced focus on business development? As a follow-up to that, with the investments you've recently made on NILEMDO, how would you expect the commercial infrastructure to need to look like with the addition of additional products within cardiovascular? Craig MillianCEO at HLS Therapeutics00:32:57Yeah, that's a good question. I think our focus first of all is executing with our core assets, no question. That's job one. In parallel, we think we have the capacity to continue to be disciplined and thoughtful in terms of how we approach business development. We are looking at. We continue to screen assets very actively and look at a lot of stuff, and they have to meet our criteria of what is sensible for us to add at this stage of our evolution. We think there are attractive assets out there. I think a good example is the deal we did with Esperion on the bempedoic acid assets. Craig MillianCEO at HLS Therapeutics00:33:42Wherever possible, we strive to leverage the infrastructure we've built in Canada, both on the cardiovascular side and on the neuropsych side, and I think even more broadly, the capabilities we have, for example, in patient support services, which in many ways are transferable across multiple high touch therapeutic areas. We think we've got capacity. I think on a case-by-case basis, we'll evaluate the return on investment of an expansion of infrastructure. Certainly there may come a time where for example, in cardiovascular, if we wanted to move into different facets of cardiovascular, we might look to expand. But rest assured, it'll be well thought through and in a disciplined way, with an opportunity to very quickly generate a positive return. Max ChmielewskiAnalyst at Stifel00:34:41Wonderful. Thanks so much, guys. John HannaCFO at HLS Therapeutics00:34:47Thank you. Operator00:34:47Thank you. Next question comes from David Martin from Bloom Burton. Please go ahead. David MartinAnalyst at Bloom Burton00:34:52Good morning. When Vascepa was first launched, if I recall correctly, a material proportion of doctors waited to prescribe the drug until there was coverage for all patients. In other words, their privately insured patients, they didn't prescribe for them until public reimbursement was in place. Do you expect the same with NILEMDO? Brian WalshCCO at HLS Therapeutics00:35:20Hi, David. Good morning. This is Brian. It's not an either/or. Obviously, with public reimbursement, it just creates a wide-open access picture and makes it much easier for physicians to prescribe. I wouldn't say physicians intentionally wait, but it becomes just more nuanced for them to find those public patients. There's private patients in their practice. That's the work that our teams do with them to help identify the support we provide to our assistance program. But no question, now we have a message of very broad private access so physicians can identify at that level, and there's really not a lot of nuance on the surface for us on the private side where we're landed with pretty broad coverage and no restrictions, essentially. We're excited for that catalyst. We see it going into Q3 to accelerate, as Craig mentioned. Brian WalshCCO at HLS Therapeutics00:36:13As we go into next year, we expect to achieve public listings, and that will certainly make those conversations and the prescribing even easier for physicians and lift both sides. Craig MillianCEO at HLS Therapeutics00:36:25Yeah, I think launching NILEMDO into this market, I think in a sense, there was almost more pent-up demand, because this truly fits an unmet need that exists within a very prevalent existing paradigm as it relates to reducing cardiovascular risk in patients at risk, requiring LDL reduction and unable to get there with the current standard of care. We know there are a lot of those patients out there. This is a product that I think many of our physicians that we call them were eagerly anticipating this launch, and I think that bears out in terms of the pretty rapid uptake that Brian described on new-to-brand. I think Vascepa required a little bit more, and I talked about this in earlier calls, a little bit more category building, so to speak, because it really is very unique in terms of what it does. Craig MillianCEO at HLS Therapeutics00:37:27That required, in some respects, a little bit more education in terms of exactly how to fit that in. That is why I think we continue to see progress with Vascepa even many years in, because I think the data are so robust, but it is also we are creating a treatment paradigm with Vascepa that frankly already existed in a sense with bempedoic acid. David MartinAnalyst at Bloom Burton00:37:51When you say no restrictions, I know Vascepa has significant restrictions on the public payer side of things. Is that differentiated on the private payer side? In other words, did Vascepa with private payers have restrictions that you are not seeing with NILEMDO? Brian WalshCCO at HLS Therapeutics00:38:10Yeah, exactly, Dave. We estimate about half the patients on Vascepa, through our private coverage, have a prior authorization to conform to the various criteria. We, at this point, with the private access we have achieved with NILEMDO, that 80% is without the need for prior authorization. Physicians know it is a full benefit, and physicians can prescribe it without the need to do paperwork. The vast majority of patients should be able to go to the pharmacy and fill a script, where half the patients with Vascepa would need to go through some paperwork process, which we support through our assistance program. But it is a barrier, it takes time, and the physicians are busy. It just creates a bit of that element of a bit of a barrier. David MartinAnalyst at Bloom Burton00:39:01Great. Last question, if I can. The 300,000+ of NILEMDO sales, how much of that do you think was stocking in the channel? Should we expect a dip in the second quarter as- Brian WalshCCO at HLS Therapeutics00:39:18No David MartinAnalyst at Bloom Burton00:39:18initial Brian WalshCCO at HLS Therapeutics00:39:20No, we see continued growth into the quarter. The channel build stays on-hand, so as we grow, they will continue to hold more. We are seeing this through the IQVIA data. We are seeing the pull-through from actual prescriptions, the new-to-brand patients. The algorithms are pretty sophisticated at this point with the wholesalers and last mile to patient to the next day. So they are not holding a lot of inventory. We are seeing this being demand-driven. Craig MillianCEO at HLS Therapeutics00:39:51Yeah, there was no heavy initial stocking. As Brian says, the stocking builds as the demand grows and the days on hand tend to be consistent. So, we continue to see on a weekly basis, increases in orders. In other words, our weekly run rate in July certainly is better than June, better than in May, and now we have not even yet been able to really activate our teams around some of the new access wins that we have. So we are looking at our internal forecast in general and raising them around NILEMDO. We expect third quarter to be much stronger than second quarter and then growing momentum as we head into 2027. David MartinAnalyst at Bloom Burton00:40:42Okay, thanks. That is it for me. Brian WalshCCO at HLS Therapeutics00:40:45Thanks, Dave. Operator00:40:48Thank you. The next question comes from Christopher Pugh with Canaccord. Please go ahead. Christopher PughAnalyst at Canaccord00:40:55Hey, good morning. Yeah, thanks for taking my question. I am on the line for Tania right now. Considering it is still early, but I am interested to hear on perhaps, are you seeing any cross-selling synergy with Vascepa for NILEMDO? Are the sales force leveraging existing relationships with the specialists to drive the trial of NILEMDO and any trends on perhaps through prescriptions? Brian WalshCCO at HLS Therapeutics00:41:26Sure. This is Brian. Thanks for the question. Exactly, and that is one of our key drivers for this deal was the synergy essentially at the base of the customer between Vascepa and the bempedoic acid franchise. It is almost a complete overlap with the call point, the same customer base. So we are seeing exactly that synergy you described. With Vascepa, any product where you are going into year six or seven, it is a little bit more difficult to bring new information. Our teams do the best they every day to do that and support patients. But bringing something new, exciting, creates an opportunity for more time in front of the customer. Brian WalshCCO at HLS Therapeutics00:42:08What I have seen and what our teams have reported is the NILEMDO story is straightforward. It fits a very established unmet need, as Craig described. We have created an access milieu which is very efficient and easy. It's creating more time for Vascepa. As we went through the quarter, Q2, despite the loss in NILEMDO, we saw acceleration in new-to-brand patients for Vascepa, and we've seen that strong year-over-year growth. So those hypotheses are playing out that we have a strong foundation as a franchise to build on, and we're excited to do so with NEXLIZET going into 2027 as well. Christopher PughAnalyst at Canaccord00:42:53That's great to hear. I just got one last question regarding the expenses. You mentioned that you're holding the line on the expense side. So would it be fair to say that the Q2 was perhaps peak spend on the S&M for NILEMDO? Craig MillianCEO at HLS Therapeutics00:43:13Just- John HannaCFO at HLS Therapeutics00:43:13I think that is- Craig MillianCEO at HLS Therapeutics00:43:14Go ahead, John. John HannaCFO at HLS Therapeutics00:43:16Yeah, I think that is fair to say that it's likely the peak of the four quarters. Craig MillianCEO at HLS Therapeutics00:43:24Yeah, I would say, we do a lot of dynamic budgeting at HLS, so we're always looking at where we can generate the best return on any dollar we spend. We look across the entire portfolio, so it may very well be where we're generating growth with NILEMDO. We might increase some investment there, but we'll look at other areas that we might be able to find some savings. That's a dynamic process. But on net, we're looking obviously to make sure we're maintaining our profitability, as John mentioned. Christopher PughAnalyst at Canaccord00:44:02Okay, that's it for me. Thanks. Craig MillianCEO at HLS Therapeutics00:44:05Thank you. Operator00:44:08Thank you. We have no further questions, and we will turn the call back over to Craig Millian for closing comments. Craig MillianCEO at HLS Therapeutics00:44:13Great. Thank you. Thank you all for participating on today's call. We look forward to reporting to you on our progress in the coming quarters and speaking with you again soon. Bye. Goodbye, and have a great afternoon. Operator00:44:27Ladies and gentlemen, this concludes your conference call for today. We thank you for participating, and we ask that you please disconnect your lines.Read moreParticipantsExecutivesDave MasonInvestor RelationsCraig MillianCEOBrian WalshCCOJohn HannaCFOAnalystsMichael FreemanEquity Research Analyst at Raymond JamesMax ChmielewskiAnalyst at StifelDavid MartinAnalyst at Bloom BurtonChristopher PughAnalyst at CanaccordPowered by