TSE:HLS HLS Therapeutics Q3 2025 Earnings Report C$4.69 +0.04 (+0.86%) As of 05/13/2026 04:00 PM Eastern ProfileEarnings HistoryForecast HLS Therapeutics EPS ResultsActual EPS-C$0.12Consensus EPS N/ABeat/MissN/AOne Year Ago EPSN/AHLS Therapeutics Revenue ResultsActual Revenue$18.81 millionExpected RevenueN/ABeat/MissN/AYoY Revenue GrowthN/AHLS Therapeutics Announcement DetailsQuarterQ3 2025Date11/13/2025TimeAfter Market ClosesConference Call DateThursday, November 13, 2025Conference Call Time8:30AM ETConference Call ResourcesConference Call AudioConference Call TranscriptSlide DeckPress ReleaseEarnings HistoryCompany ProfileSlide DeckFull Screen Slide DeckPowered by HLS Therapeutics Q3 2025 Earnings Call TranscriptProvided by QuartrNovember 13, 2025 ShareLink copied to clipboard.Key Takeaways Positive Sentiment: Adjusted EBITDA improved to US$4.9M in Q3 (+19% YoY) and US$13.9M YTD (+25%), and management says it is on track to hit full‑year adjusted EBITDA guidance of 17%–23% growth (US$19.5–20.5M). Neutral Sentiment: Pasipa prescriptions are up 24% YTD and the salesforce is fully redeployed after a major rebuild, but management lowered full‑year Pasipa revenue growth guidance to the mid‑teens (from 18%–26%) given slower‑than‑expected adoption. Negative Sentiment: Management now expects a 4%–5% decline in Canadian Clozaril revenue for 2025 due to inventory timing and competitive pressure in Ontario, although patient numbers are broadly stable and U.S. Clozaril is outperforming expectations. Positive Sentiment: HLS expects Health Canada feedback in Q4 and plans a Q2‑2026 launch of bempedoic acid (Nilembo/NexleZed), targeting an addressable market of >500,000 Canadians and positioning an oral option ahead of costly injectables. Positive Sentiment: The balance sheet has strengthened — term loans down to CAD53.1M (net debt CAD43.5M), refinanced into a CAD107M Canadian facility with ~CAD1.5M annual interest savings — enabling continued debt reduction, buybacks, and selective BD opportunities. AI Generated. May Contain Errors.Conference Call Audio Live Call not available Earnings Conference CallHLS Therapeutics Q3 202500:00 / 00:00Speed:1x1.25x1.5x2xTranscript SectionsPresentationParticipantsPresentationSkip to Participants Moderator00:00:00Morning and welcome to Q3 2025 financial results conference call for HLS Therapeutics. At this point, I would like to turn the call over to David Mason, Investor Relations, for the introductory remarks. Please go ahead. David MasonInvestor Relations at HLS Therapeutics00:00:14Thank you. 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 and 9 months ended September 30, 2025. This news release, along with our MD&A and financial statements, is available on HLS's website and on SEDAR Plus. 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 at our website on the events and presentations 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. David MasonInvestor Relations at HLS Therapeutics00:01:14Risk factors that could affect results are detailed in the company's annual information form, which has been filed on SEDAR Plus. 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 Plus and on our website. Please note that all financial information provided is in U.S. dollars unless otherwise specified. I would now like to turn the meeting over to Mr. Millian. Please go ahead. Craig MillianCEO at HLS Therapeutics00:01:51Thanks, Dave. Good morning, everyone, and thank you for joining us. On our call today, I'll review quarterly and year-to-date highlights, along with progress against corporate priorities. Brian will go into further detail on product performance, along with an update on launch preparations. John will follow with a detailed look at the numbers. Following John, we'll hold a Q&A session. I want to start by highlighting the progress we've made over the past 2 years, improving profitability and cash flow, and strengthening our financial position. We believe these improvements were essential to set the stage for future growth. I'll start with Adjusted EBITDA, which was $4.9 million in the third quarter, up 19% year-over-year, and $13.9 million year-to-date, up 25% over the same 2024 period. With the progress we've made year-to-date, we are on track to reach our target Adjusted EBITDA range for the full year. Craig MillianCEO at HLS Therapeutics00:02:56Following an inflection point 2 years ago in the third quarter of 2023, we've demonstrated steady quarterly improvement in Adjusted EBITDA, excluding royalties. In the third quarter, we continued that positive trend. In that 2 year window, Adjusted EBITDA, excluding royalties, has increased by more than 85%. This performance is a result of the operational improvements we've made over the past couple of years, focusing on the key performance drivers for our promoted products while significantly reducing operating expenses and delevering our balance sheet. Financial discipline we've instilled across the organization is generating results, with strong operating cash flow and continued debt reduction. John will provide more details on our financial position in his section. On the revenue side, while Canadian product sales have grown 2% year-to-date in local currency, we have faced several headwinds throughout 2023, and in the third quarter, revenues were down 4%. Let's start with Pasipa. Craig MillianCEO at HLS Therapeutics00:04:08With an eye towards strengthening commercial capabilities for both Pasipa and ahead of the pempedoic acid launch, we made substantial and purposeful changes to the sales force this year. In 2025, more than half of our territories turned over as we proactively recruited, upgraded, and onboarded new talent. Those geographies are now filled with highly experienced and motivated sales representatives who are building momentum in their territories. With a fully deployed customer-facing organization, this completes the transition that began late last year with our exit from the Pfizer promotional services agreement. Even with the scope of these changes, Pasipa has managed to grow prescriptions at a substantial rate of 24% year-to-date, and the third quarter was its most profitable quarter since launch. That said, Pasipa prescription growth is below the ambition we set for the year. Craig MillianCEO at HLS Therapeutics00:05:10Based on year-to-date results, we now expect Pasipa revenue growth on a percentage basis in the mid-teens for the full year on a local currency basis, compared to our prior range of 18%-26% growth. We are optimistic that with a fully trained and deployed sales team, we will continue to grow Pasipa in 2026 and beyond. Turning to Clozaril, we had an ambitious plan to grow our patient numbers this year across Canada. While we still see many targeted growth opportunities ahead, they are taking longer to realize than anticipated. We have adjusted our guidance and now project a decline of 4%-5% for the Canadian Clozaril business in local currency for the full year. We estimate that about a third of the projected revenue decline is due to fluctuations in inventory at some hospital-based accounts, which had the effect of shifting revenue into 2024. Craig MillianCEO at HLS Therapeutics00:06:07We expect these inventory effects to impact 2025 comparisons to 2024, but not beyond. Clozaril also recently faced increased competitive pressure in Ontario, where we maintain a very high market share. Earlier this year, a number of hospital accounts in Ontario were in play due to a large buy-and-group contract that was up for a multi-year renewal. We successfully defended the vast majority of Clozaril business in Ontario, where a satisfied patient base, differentiated CSUN services, and innovative Pronto offering helped support the Clozaril value proposition. Despite the increased competitive activity in Ontario, overall Clozaril patient numbers in Canada are down less than 1% versus prior year, and this is due to sizable gains we have achieved in other parts of the country, particularly the Western provinces. Taking a slightly longer view, Clozaril patient numbers in Canada are actually up about 1% since the end of 2023. Craig MillianCEO at HLS Therapeutics00:07:13In addition, our U.S. Clozaril business has shown resilience and is currently outperforming expectations for the year. This stable U.S. performance represents a meaningful improvement over the historical trend. To summarize our outlook for the rest of the year, profitability remains strong, and we expect to grow Adjusted EBITDA to meet our guidance range of 17%-23% growth, which translates to $19.5-$20.5 million. Based on our updated product sales guidance, we are now providing a consolidated revenue estimate for the year of $55-$56 million. Looking toward 2026, we expect to grow both top-line and Adjusted EBITDA next year. Although we saw some recent increased competitive activity against Clozaril in Ontario, we have successfully grown our existing patient base over the past 2 years and expect business to stabilize in Canada. Craig MillianCEO at HLS Therapeutics00:08:15For Pasipa, now that our sales force is fully staffed, we're starting to see the positive impact, including recent increases in new-to-brand patients. This makes us optimistic for growth prospects. Of course, we're preparing to expand our cardiovascular portfolio with a second quarter launch of bempedoic acid, which will contribute to revenue in 2026. We'll provide a more detailed financial outlook for 2026 when we issue our year-end results in March. While we manage the near-term objective of profitably growing our existing product portfolio, I want to emphasize how excited we are about the growth opportunity ahead of us as we build HLS into a leading cardiovascular company in Canada. The introduction of bempedoic acid will help address a large and growing patient population of more than 500,000 Canadians who could benefit from additional LDL cholesterol lowering. Craig MillianCEO at HLS Therapeutics00:09:16This novel medicine will represent an important addition to the clinical armamentarium, as there is a need for treatments beyond statins and ahead of the expensive injectables currently available. We are excited to leverage powerful operational and platform synergies with Pasipa to position HLS as the leader in delivering novel cardiovascular risk-reducing oral therapies to the Canadian market. Brian will provide more details on our launch preparations and the commercial opportunity, but I want to underscore that this launch represents a pivotal moment for HLS and will drive growth for years to come. Even as we set the stage for future growth, we plan to largely hold the line on operating expenses in 2026. As said previously, we've built a cost structure that can support both our existing portfolio and the new product launches without significant incremental investment. Craig MillianCEO at HLS Therapeutics00:10:17The financial foundation for HLS is solid, with improved profitability and cash flow. Our new credit agreement announced in the third quarter with favorable terms further strengthens our financial position. The agreement has a new syndicate of lenders and provides stability, lower interest expense, and greater flexibility to pursue strategic growth opportunities to expand our portfolio. With that, I'll turn it over to Brian to discuss our commercial performance and launch preparations. Brian? Brian WalshChief Commercial Officer at HLS Therapeutics00:10:52Thanks, Craig, and good morning, everyone. I'll walk through our Q3 and year-to-date product performance and provide an update on our bempedoic acid launch preparations. Starting with Clozaril, our U.S. Clozaril business has performed well, and year-to-date sales were up 1%. This is a meaningful improvement over the historical trend and is the result of a durable established patient base coupled with targeted new patient growth through our specialty pharmacy partnership. For Clozaril in Canada, as Craig noted, we continue to drive strong growth in the West, including 11% patient number growth in British Columbia. That was offset by expected patient attrition in Quebec and some competitive pressures at select accounts in Ontario. Brian WalshChief Commercial Officer at HLS Therapeutics00:11:38While we have experienced some unit impact from the pressures in Ontario, we have successfully defended our value proposition in the vast majority of accounts while maintaining our net pricing integrity, which preserves the foundation for a healthy, sustainable business moving forward. Despite these pressures, our patient numbers are down less than 1% at the end of Q3 versus the same time last year and up 1% versus the end of 2023, demonstrating the solid fundamentals underpinning our Clozaril franchise in Canada. Importantly, Clozapine is significantly underutilized across Canada as the only approved product for treatment-resistant schizophrenia. This context creates multiple pathways for our team to bring the lifesaving Clozaril brand and our differentiated CSUN services to more patients across Canada. Looking at Pasipa, Q3 unit volume grew 22% compared to Q3 last year, and year-to-date unit growth was 24%. Brian WalshChief Commercial Officer at HLS Therapeutics00:12:44The key story with Pasipa this year has been our sales force rebuild following the Pfizer transition and ahead of our bempedoic acid launch. As Craig shared, we made many of these changes with the aim of strengthening our commercial capabilities for both Pasipa, but also before we launched bempedoic acid. As a result, throughout 2023, more than half of our territories were open for some period of time as we recruited and onboarded new representatives. At the end of Q3, we had reached full deployment across all territories, and we are very excited about the talents that we have attracted to join HLS. While everyone we hired is an experienced specialty sales representative, it still takes several months for a new representative to get fully trained and established with their new customers. Brian WalshChief Commercial Officer at HLS Therapeutics00:13:32We are seeing very good early signs that our new team members are becoming increasingly productive, which is evident by overall growth in new patient starts. For the first time this year, we grew new patient starts each month in the quarter versus the prior year. We are also seeing improved depth of prescribing by growing consistent prescribers 5% versus Q2 of this year and 29% versus Q3 of last year. We expect this growth to accelerate in the coming quarters as our transform sales team gains further traction, driving a more meaningful impact on our full year 2026. The fundamentals supporting Pasipa remain strong. The product remains prominent in the CCS treatment guidelines, and Pasipa maintains excellent formulary access across both public and private payers. We continue to take proactive steps to streamline the reimbursement process and improve retention rates for patients that are covered by private plans. Brian WalshChief Commercial Officer at HLS Therapeutics00:14:35Now let me turn to the exciting upcoming launch of bempedoic acid. As mentioned previously, Nexletol and NexleZed are the commercial product names used in the U.S., but we expect a variation in the brand name for the monotherapy once Health Canada approval is finalized. The monotherapy is a daily oral non-statin treatment containing the novel compound bempedoic acid. Its brand name in Canada will be Nilembo, which is aligned to the brand name in Europe. The second product is the fixed-dose combination of bempedoic acid with ezetimibe in a single daily pill, and in Canada, it will be marketed as NexleZed, the same name as in the U.S. What makes these products differentiated is they add a second completely independent pathway to cardiovascular risk reduction alongside Pasipa's unique mechanism. These new products address a very large addressable market focused on LDL cholesterol reduction. Brian WalshChief Commercial Officer at HLS Therapeutics00:15:35LDL is the ultimate biomarker for cardiovascular risk. It's integrated into every clinical guideline and physician practice pattern. 40% of at-risk patients and half of high-risk atherosclerotic cardiovascular disease patients in Canada do not achieve their CCS guideline-recommended LDL target. These elevated LDL levels put patients at significant risk of future catastrophic vascular events like myocardial infarction, stroke, and cardiovascular death. The unmet medical need is significant, and we estimate more than 500,000 Canadians could potentially benefit from these medicines. This gives us a clear, well-established entry point for these products into the Canadian cardiovascular system. The clinical profile of these products is very compelling for physicians, patients, and payers. Brian WalshChief Commercial Officer at HLS Therapeutics00:16:28We will launch Nilembo with the results from the CLEAR outcomes trial, a nearly 14,000-patient randomized double-blind cardiovascular outcome study that demonstrated meaningful reduction in major adverse cardiovascular events, or MACE, in patients unable to take recommended statin therapy. Nilembo and NexleZed provide a novel oral pathway for LDL lowering while being less likely to cause muscle-related side effects that limit statin adherence and can be used alone or in combination with other LDL-lowering therapies. In terms of clinical practice, physicians typically start patients with a statin, then add ezetimibe if additional LDL lowering is needed. If patients still aren't at goal, the current standard of care moves to PCSK9 inhibitors, which are injectable, expensive, and generally reserved for only the highest-risk patients. Brian WalshChief Commercial Officer at HLS Therapeutics00:17:25Nilembo and NexleZed slot in ahead of PCSK9s in this treatment algorithm, providing a simpler, lower-cost oral option for patients who need additional LDL lowering but aren't appropriate candidates for injectable therapy. Our pre-launch preparations have accelerated since last quarter. We're finalizing our dossiers for pricing and reimbursement discussions. Our medical teams, who have been established for several years with our KOLs on Pasipa, have started engaging with their customers on bempedoic acid story this summer, and they have been met with a high level of enthusiasm regarding the significant unmet need that the product addresses. On timing, we expect to hear from Health Canada in Q4, which would put us on track for a Q2 2026 commercial launch. By that time, we expect to have product available and to have achieved meaningful coverage with private insurers. Brian WalshChief Commercial Officer at HLS Therapeutics00:18:19Our engagement on the public reimbursement will continue throughout 2026, with the goal of achieving favorable provincial listing agreements beginning in 2027. The strategic synergies with Pasipa are significant. The Canadian Cardiovascular Society guidelines recommend both further LDL lowering for patients not at goal and consideration of Pasipa treatment for patients with elevated triglycerides as a marker of increased cardiovascular event risk. With our expanded portfolio, we'll be well-positioned as the Canadian leader in oral cardiovascular risk reduction, able to partner with physicians to address a much broader set of patients working to reduce their remaining risk. Our customer-facing teams are energized and ready to launch these new products. With that, I'll turn it over to John for the financial results. John? John HannaCFO at HLS Therapeutics00:19:11Thank you, Brian, and good morning, everyone. I'll focus my remarks on our Q3 and year-to-date financial performance, the continued strengthening of our balance sheet, and our capital allocation approach. Starting with revenue, total revenue for Q3 was CAD 13.5 million compared to $14.1 million in Q3 last year. Year-to-date revenue was CAD 40.3 million compared to CAD 41.1 million in the same period last year. Craig and Brian have already covered off the key factors impacting revenue for the quarter and the year. Excluding royalties, revenue from Canadian product sales in local currency and revenue from U.S. Clozaril sales were both up on a year-to-date basis by 2.3% and 1%, respectively. The timing of orders can impact quarterly results, and for this reason, we view year-to-date revenue as a more relevant measure of the comparison of year-over-year revenue performance. Royalty revenue was CAD 180,000 in Q3 compared to CAD 195,000 in Q3 last year. John HannaCFO at HLS Therapeutics00:20:27Royalty revenue comparisons have normalized here in Q3 2025 following the sale of the Zempezime royalty in Q2 2024. HLS has one remaining royalty interest. Foreign exchange continues to be a headwind when translating Canadian dollar sales to U.S. dollars for reporting purposes. Year-to-date, foreign exchange has negatively impacted consolidated revenue by approximately $0.8 million. On the expense side, we continue to demonstrate strong operational discipline, helping to drive increases in Adjusted EBITDA and cash flow. Q3 operating expenses comprising sales and marketing, medical regulatory and patient support, and G&A were down 22% compared to Q3 last year. Year-to-date, these expenses were down 20%. This performance reflects our focus over the past 12 to 18 months on operational efficiency and driving product profitability. Cost of sales have increased in the quarter and year-to-date periods, largely due to growth in unit volumes and net sales for Pasipa. John HannaCFO at HLS Therapeutics00:21:46As Craig mentioned earlier, Adjusted EBITDA growth in Q3 and the year-to-date period was strong, increasing 19% and 25%, respectively. Similar to the discussion on OpEx, this is due to our efforts to optimize operations and drive product profitability. I want to highlight the consistent improvement we've made in our profitability trajectory. As shown in the slide in our presentation, on a trailing 12-month basis, Adjusted EBITDA, excluding royalties, has shown consistent quarterly improvement since bottoming out in late 2023. Q3 continues this positive trend. As Craig mentioned, since Q3 2023, Adjusted EBITDA ex royalties has grown by 87%. For the third quarter, the direct brand contribution from Clozaril to Adjusted EBITDA was CAD 6.3 million, while the direct brand contribution from Pasipa was CAD 0.6 million. Year-to-date, contributions were CAD 19.2 million for Clozaril and CAD 0.7 million for Pasipa. John HannaCFO at HLS Therapeutics00:22:59Cash from operations in Q3 was CAD 2.5 million, up 67% compared to Q3 last year. Year-to-date, cash from operations was CAD 10.6 million, up 121% versus the same period last year. This strong operating cash flow performance reflects our improved profitability. Another driver of our cash flow improvement has been the reduction in interest expense. Year-to-date, we've reduced interest expense by 38%, saving $2.6 million. This reflects the significant progress we've made in paying down debt and lowering our effective interest rate. Turning to the balance sheet, at quarter end, the carrying amount of our term loans stood at CAD 53.1 million, down CAD 12.9 million, or 19%, from CAD 67.4 million at December 31, 2024, and down CAD 33.6 million, or almost 40%, since the end of 2023. As a result of our continued debt reduction, net debt stood at CAD 43.5 million at quarter end, compared to CAD 50 million at December 31, 2024. John HannaCFO at HLS Therapeutics00:24:11Our deleveraging, combined with our improved operational performance, has fundamentally strengthened our financial position and created greater flexibility for capital allocation. Further strengthening our financial position, in August, we successfully refinanced our debt facility, entering into a new Canadian-denominated credit agreement with total borrowing capacity of $107 million. National Bank of Canada is the lead, and the syndicate includes TD Bank, RBC, and Innovation Federal Credit Union. This replaces our previous U.S. dollar facility and extends our maturity to August 2029. The Canadian-denominated structure provides a natural hedge against our predominantly Canadian operations while reducing foreign exchange exposure. We've achieved meaningful interest rate savings of 25-50 basis points on spreads, plus over 100 basis points from favorable Canadian base rates. This should net us annual savings of approximately CAD 1.5 million in interest expense. This enhanced financial flexibility supports our capital allocation priorities. John HannaCFO at HLS Therapeutics00:25:25Our outlook for capital allocation remains balanced and is focused on 3 areas: 1, continued debt reduction, returning capital to shareholders through share buybacks, and 3, strategic portfolio expansion. Importantly, we've funded all 3 priorities: debt reduction, share buybacks, and portfolio expansion through operating cash flow without requiring additional financing. In summary, we're delivering on our profitability commitments, generating strong cash flow, and continuing to strengthen our balance sheet. We've built a solid financial foundation that provides flexibility to invest in our portfolio while also returning capital to shareholders. With that, I'll turn it back to Craig for closing remarks. Craig? Craig MillianCEO at HLS Therapeutics00:26:15Thank you, John. In closing, our consistently improving profitability demonstrates that the operational transformation we've executed is working. We're generating improved cash flow, significantly reducing our debt burden, and building a more sustainable cost structure that can also support growth. The pending approval of bempedoic acid will transform our cardiovascular franchise in Canada and further establish HLS as a leader in delivering novel oral therapies to reduce cardiovascular risk. We remain focused on execution and are confident that our strategy, our team, and our growing portfolio of important medicines will continue to deliver results and create value. That concludes our prepared remarks. At this point, I'll ask the operator to please provide instructions for asking questions. Operator? Moderator00:27:09Thank you. Ladies and gentlemen, we will now begin the question-and-answer session. To ask a question, you may press the star followed by the number 1 on your telephone keypad. If you're using a speakerphone, please speak up your headset before pressing the keys. To withdraw your question, please press the star followed by the number 2. With that, our first question comes from the line of Michael Freeman with Raymond James. Please go ahead. Michael FreemanResearch Analyst at Raymond James00:27:33Hey, good morning, everybody, and congratulations on all this progress. I think as a quick first one, I wonder if you could describe any interactions you've had with Health Canada on bempedoic acid. Craig MillianCEO at HLS Therapeutics00:27:51Thanks, Michael, for the question. I'll turn it over to Brian. Brian WalshChief Commercial Officer at HLS Therapeutics00:27:55Hey, Michael, good morning. You were progressing with the regulatory review. We've had very good engagement on bempedoic acid, and you were expecting to hear from them this quarter. We're on track for a product launch in Q2 of next year. Michael FreemanResearch Analyst at Raymond James00:28:14Okay. Okay. Now, on the Clozaril business, you described well some of these Canadian headwinds. I wonder what your overall plans are for maintaining or growing this business, I guess, broadly, but specifically in Canada. You have a very strong market share in Ontario that maybe competitors are nibbling away at, but there does seem to be quite a lot of headroom in other provinces in Canada. I wonder what your game plan is. Brian WalshChief Commercial Officer at HLS Therapeutics00:28:51Yeah. Yeah, it's a great question, Michael. That's where for this brand, given the significant underutilization of Clozaril, we see a lot of pathways to growth. Over the last couple of years, we've reported on significant growth, double-digit growth in the Western provinces. We still have less than a third of those markets, so we still see significant headroom, good profitability opportunities in those markets. We have been making subtle changes to shift resources to accelerate that growth. Even within Ontario, where there's some modest pressure, there's still significant population growth and growth opportunities throughout the province. Craig MillianCEO at HLS Therapeutics00:29:35Yeah. And just to add, even in Quebec, where you may recall a year or so ago, a little over a year, we actually changed our model there to really focus on patient retention due to some of the challenges in terms of acquisition of patients in Quebec. That has been a resounding success. We have been able to limit any sort of attrition in Quebec to low single-digit % and really patient-by-patient work to retain everyone of our patients. The stickiness of that patient population in Quebec is quite remarkable. Often when there is attrition, it is due to reasons such as a patient passing away, for example, not necessarily due to a switch. The strategy has worked in terms of maximizing our retention of patients in Quebec, defending our really dominant share in Ontario. Craig MillianCEO at HLS Therapeutics00:30:35We have fantastic relationships at the major accounts there, the major mental health institutions, and we think there are still opportunities to grow. Admittedly, it is certainly a competitive space. As Brian said, really a lot of headroom for growth out in the Western provinces. Michael FreemanResearch Analyst at Raymond James00:30:57I wonder if you could provide similar color on Clozaril in the U.S. Brian WalshChief Commercial Officer at HLS Therapeutics00:31:03Yeah. Very different dynamic. It's a very stable patient population, but a different share, lower share, higher value per patient. Our regular core business has been very stable. As accounts there, we tend to have more private pay patients. We've been able to offset some natural patient attrition through targeted growth through specialty pharmacy, where we're able to offer financial assistance and educational support programs. We continue to see that we've achieved, I think, a level of stability with that business, and we can see that continuing in the coming years. Michael FreemanResearch Analyst at Raymond James00:31:55Excellent. Now, last one for me. There was some mention of pursuing business development as a result of you guys strengthening your balance sheet. What should we expect in terms of sort of structure of in-licensing, perhaps, or size of deal? Would we expect something similar to what we saw with bempedoic acid, or are you scaling up your ambition? Craig MillianCEO at HLS Therapeutics00:32:29It's a good question. What I would say is, so we love the bempedoic acid deal, and obviously, there's other deals of that magnitude. We think this is going to create significant shareholder value. We think these are products that will generate tens of millions of dollars in revenue and, again, fit so beautifully with the infrastructure we already have in place and really building our positioning as a premier cardiovascular company in Canada. Obviously, the opportunity to continue to do deals like that are very attractive, albeit not necessarily an infinite number of those opportunities. I do think with the strengthening balance sheet and the new debt facility, that does, I'd say, widen the aperture in terms of the type of deals we can do. Craig MillianCEO at HLS Therapeutics00:33:22I think right now, our focus is on continuing to bring in assets that are materially significant, that will add significantly material revenues to our top line. We think that's very important. We're not interested in things that are too. Moderator00:34:09Excuse me, ladies and gentlemen. Please continue to stand by. Ladies and gentlemen, thank you for standing by. The presenter is now reconnected. Please go ahead. Craig MillianCEO at HLS Therapeutics00:35:32Apologies. We're in a meeting room at a hotel, and the Wi-Fi dropped here. I'm not sure when the call dropped. I know we had a question from Michael. Michael FreemanResearch Analyst at Raymond James00:35:45You're in the criteria. Craig MillianCEO at HLS Therapeutics00:35:46Yeah. Yeah. So I mean, I'll just be brief. The answer is yes. We're looking at deals, I think, similar in scope to what we've done, but I would say, again, with the strengthened balance sheet and with kind of the increased flexibility with the lending agreement, we're in a position, I think, to broaden the aperture. Looking at things that obviously fit with our model in Canada, and that can easily be broadened, but that have significant sales potential. Obviously, we'll be opportunistic as well. I think we're looking at opportunities to expand our business as well in the U.S., recognizing that those will be maybe challenging to identify. We're confident we can continue to build out our business there as well. Stay tuned. Craig MillianCEO at HLS Therapeutics00:36:38We're very active, and we're very committed to continuing to grow top line now that we've really put our financial house in order and have a cost structure that we think can support a lot more growth. Michael FreemanResearch Analyst at Raymond James00:36:54Okay. Thank you very much. I'll pass the line. Moderator00:37:00Thank you. If you would like to ask a question, simply press the star 1 on your telephone keypad. Your next question comes from David Martin with Bloomberg. Please go ahead. David MartinAnalyst at Bloomberg00:37:12Good morning. First question. The CEPA scripts were up 22% in third quarter year over year, but the net sales were up only 2.1% in local currency. You mentioned inventory fluctuations. I'm wondering, are you seeing inventories more stable or even some restocking post Q3? Are you also seeing pressure on your net pricing? Did that feed into it as well? Craig MillianCEO at HLS Therapeutics00:37:40Yeah. I don't know, John, if you want to comment on this. I mean, I would say that, and this has historically been the case, obviously the growth and demand outpacing growth in net sales. This is really an artifact of having launched first into the private markets and then subsequently launching into the public markets with the different economics of that. Over time, we went from 100% of our business being private to now a blend. The good news is now we're starting to see stabilization as we've expected. As we continue to grow in both segments, both channels, we continue to see more significant growth, I would say, on the public side. That does drive an increase in rebates. That certainly has some impact on gross to net. The goal has been to stabilize that payer mix. Craig MillianCEO at HLS Therapeutics00:38:43When that occurs, we believe we'll see a narrowing of that difference between demand growth and net sales growth, but we're not quite there yet. I think probably the largest explanation for that, David, is payer mix. I don't know, John, if there's any other elements that you would. John HannaCFO at HLS Therapeutics00:39:02No, I wouldn't correct that. I think you covered it well. We did comment a little bit on inventory for Clozaril for the CEPA. It's really sort of the routine wholesaler orders that our biggest wholesalers place big orders, and depending on where they drop. There was nothing significant to comment on there for the quarter. Craig MillianCEO at HLS Therapeutics00:39:22Yeah. There is lumpiness for certain in terms of order patterns, which is why we, especially with a limited number of products, any large order that takes place in 1 quarter versus another can influence year-over-year comparisons, which is why we tend to focus more on year-to-date versus quarter because there is that variability. David MartinAnalyst at Bloomberg00:39:45Okay. Was there a large order that got pushed from Q3 into Q4? Craig MillianCEO at HLS Therapeutics00:39:51No. As I say, nothing specific to this quarter. David MartinAnalyst at Bloomberg00:39:54Okay. For Clozaril, the growth out west, is that mainly coming from taking share from competitors, or are you seeing increasing overall usage of clozapine? Brian WalshChief Commercial Officer at HLS Therapeutics00:40:10It's both. We're population growth and utilization of clozapine, but our share has been increasing steadily as well. It's a population there, like other places in Canada, where there's this large installed population, and we're competing for the new starts. I think we're competing even ahead of our market share in that dynamic portion of the market. It's both we're winning more in the new start population, but we're seeing the overall, we're seeing utilization increase. David MartinAnalyst at Bloomberg00:40:47Okay. Great. Last question. You've obviously got good infrastructure to take on additional cardiovascular drugs. If you took on another psychiatry drug, would you need to build out your salesforce, or could that be layered onto the group you've got now? Brian WalshChief Commercial Officer at HLS Therapeutics00:41:08It would depend on the indication specifically. I think most of the opportunities on the neuroscience side would require some incremental build. We believe we still have capacity to bring in additional cardiovascular products within our existing footprint, just given the coverage and life cycle of the CEPA. Craig MillianCEO at HLS Therapeutics00:41:31Yeah. We definitely have capacity, we believe, on the cardiovascular side. That'll certainly continue to be a focus. We think we've got a really, now with the upgrade in the salesforce and bringing on some super talented folks, a really strong customer-facing organization in addition to our medical team. Similarly, on the Clozaril side, we have a very strong multidisciplinary team. As Brian said, there's some really strong foundational elements to that team, which gives us the versatility to bring in a range of products that we could then adapt accordingly. That would require most likely some additional salespeople. We have a fairly light footprint. David MartinAnalyst at Bloomberg00:42:20Okay. Thank you. Moderator00:42:24Thank you. We have no further questions at this time. I would like to turn it back to Craig Millian for closing remarks. Craig MillianCEO at HLS Therapeutics00:42:32Thank you, operator. Thank you all for participating on today's call. We look forward to reporting to you on progress in the coming quarters and speaking with you again soon. Thanks. Have a great morning. Moderator00:42:47Thank you, presenters. Ladies and gentlemen, this concludes today's conference call. Thank you all for joining me now. This con.Read moreParticipantsExecutivesCraig MillianCEOJohn HannaCFOBrian WalshChief Commercial OfficerDavid MasonInvestor RelationsAnalystsModeratorMichael FreemanResearch Analyst at Raymond JamesDavid MartinAnalyst at BloombergPowered by Earnings DocumentsSlide DeckEarnings Release HLS Therapeutics Earnings HeadlinesHLS Therapeutics to Host Q1 2026 Financial Results Conference CallMay 1, 2026 | finance.yahoo.comHLS Therapeutics to Present at the 2026 Bloom Burton & Co. Healthcare Investor ConferenceApril 14, 2026 | finance.yahoo.comYour $29.97 book is free todayWhy Some Traders Skip Stocks Entirely You don't need a big account to trade options. In fact, options can give you up to 12 times the leverage of stocks — with a fraction of the capital tied up. This free guide lays it all out in plain English — from A to Z, with step-by-step examples you can follow in your own account.May 14 at 1:00 AM | Profits Run (Ad)HLS Therapeutics Inc (HLTRF) Q4 2025 Earnings Call Highlights: Strong EBITDA Growth and ...March 12, 2026 | finance.yahoo.comHLS Therapeutics Announces NILEMDOTM (bempedoic acid) is now available in Canada for the Reduction of LDL-Cholesterol in Patients at Risk of Cardiovascular DiseaseMarch 5, 2026 | finance.yahoo.comHLS Therapeutics to Host Fiscal 2025 Financial Results Conference CallFebruary 26, 2026 | finance.yahoo.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 Moderator00:00:00Morning and welcome to Q3 2025 financial results conference call for HLS Therapeutics. At this point, I would like to turn the call over to David Mason, Investor Relations, for the introductory remarks. Please go ahead. David MasonInvestor Relations at HLS Therapeutics00:00:14Thank you. 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 and 9 months ended September 30, 2025. This news release, along with our MD&A and financial statements, is available on HLS's website and on SEDAR Plus. 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 at our website on the events and presentations 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. David MasonInvestor Relations at HLS Therapeutics00:01:14Risk factors that could affect results are detailed in the company's annual information form, which has been filed on SEDAR Plus. 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 Plus and on our website. Please note that all financial information provided is in U.S. dollars unless otherwise specified. I would now like to turn the meeting over to Mr. Millian. Please go ahead. Craig MillianCEO at HLS Therapeutics00:01:51Thanks, Dave. Good morning, everyone, and thank you for joining us. On our call today, I'll review quarterly and year-to-date highlights, along with progress against corporate priorities. Brian will go into further detail on product performance, along with an update on launch preparations. John will follow with a detailed look at the numbers. Following John, we'll hold a Q&A session. I want to start by highlighting the progress we've made over the past 2 years, improving profitability and cash flow, and strengthening our financial position. We believe these improvements were essential to set the stage for future growth. I'll start with Adjusted EBITDA, which was $4.9 million in the third quarter, up 19% year-over-year, and $13.9 million year-to-date, up 25% over the same 2024 period. With the progress we've made year-to-date, we are on track to reach our target Adjusted EBITDA range for the full year. Craig MillianCEO at HLS Therapeutics00:02:56Following an inflection point 2 years ago in the third quarter of 2023, we've demonstrated steady quarterly improvement in Adjusted EBITDA, excluding royalties. In the third quarter, we continued that positive trend. In that 2 year window, Adjusted EBITDA, excluding royalties, has increased by more than 85%. This performance is a result of the operational improvements we've made over the past couple of years, focusing on the key performance drivers for our promoted products while significantly reducing operating expenses and delevering our balance sheet. Financial discipline we've instilled across the organization is generating results, with strong operating cash flow and continued debt reduction. John will provide more details on our financial position in his section. On the revenue side, while Canadian product sales have grown 2% year-to-date in local currency, we have faced several headwinds throughout 2023, and in the third quarter, revenues were down 4%. Let's start with Pasipa. Craig MillianCEO at HLS Therapeutics00:04:08With an eye towards strengthening commercial capabilities for both Pasipa and ahead of the pempedoic acid launch, we made substantial and purposeful changes to the sales force this year. In 2025, more than half of our territories turned over as we proactively recruited, upgraded, and onboarded new talent. Those geographies are now filled with highly experienced and motivated sales representatives who are building momentum in their territories. With a fully deployed customer-facing organization, this completes the transition that began late last year with our exit from the Pfizer promotional services agreement. Even with the scope of these changes, Pasipa has managed to grow prescriptions at a substantial rate of 24% year-to-date, and the third quarter was its most profitable quarter since launch. That said, Pasipa prescription growth is below the ambition we set for the year. Craig MillianCEO at HLS Therapeutics00:05:10Based on year-to-date results, we now expect Pasipa revenue growth on a percentage basis in the mid-teens for the full year on a local currency basis, compared to our prior range of 18%-26% growth. We are optimistic that with a fully trained and deployed sales team, we will continue to grow Pasipa in 2026 and beyond. Turning to Clozaril, we had an ambitious plan to grow our patient numbers this year across Canada. While we still see many targeted growth opportunities ahead, they are taking longer to realize than anticipated. We have adjusted our guidance and now project a decline of 4%-5% for the Canadian Clozaril business in local currency for the full year. We estimate that about a third of the projected revenue decline is due to fluctuations in inventory at some hospital-based accounts, which had the effect of shifting revenue into 2024. Craig MillianCEO at HLS Therapeutics00:06:07We expect these inventory effects to impact 2025 comparisons to 2024, but not beyond. Clozaril also recently faced increased competitive pressure in Ontario, where we maintain a very high market share. Earlier this year, a number of hospital accounts in Ontario were in play due to a large buy-and-group contract that was up for a multi-year renewal. We successfully defended the vast majority of Clozaril business in Ontario, where a satisfied patient base, differentiated CSUN services, and innovative Pronto offering helped support the Clozaril value proposition. Despite the increased competitive activity in Ontario, overall Clozaril patient numbers in Canada are down less than 1% versus prior year, and this is due to sizable gains we have achieved in other parts of the country, particularly the Western provinces. Taking a slightly longer view, Clozaril patient numbers in Canada are actually up about 1% since the end of 2023. Craig MillianCEO at HLS Therapeutics00:07:13In addition, our U.S. Clozaril business has shown resilience and is currently outperforming expectations for the year. This stable U.S. performance represents a meaningful improvement over the historical trend. To summarize our outlook for the rest of the year, profitability remains strong, and we expect to grow Adjusted EBITDA to meet our guidance range of 17%-23% growth, which translates to $19.5-$20.5 million. Based on our updated product sales guidance, we are now providing a consolidated revenue estimate for the year of $55-$56 million. Looking toward 2026, we expect to grow both top-line and Adjusted EBITDA next year. Although we saw some recent increased competitive activity against Clozaril in Ontario, we have successfully grown our existing patient base over the past 2 years and expect business to stabilize in Canada. Craig MillianCEO at HLS Therapeutics00:08:15For Pasipa, now that our sales force is fully staffed, we're starting to see the positive impact, including recent increases in new-to-brand patients. This makes us optimistic for growth prospects. Of course, we're preparing to expand our cardiovascular portfolio with a second quarter launch of bempedoic acid, which will contribute to revenue in 2026. We'll provide a more detailed financial outlook for 2026 when we issue our year-end results in March. While we manage the near-term objective of profitably growing our existing product portfolio, I want to emphasize how excited we are about the growth opportunity ahead of us as we build HLS into a leading cardiovascular company in Canada. The introduction of bempedoic acid will help address a large and growing patient population of more than 500,000 Canadians who could benefit from additional LDL cholesterol lowering. Craig MillianCEO at HLS Therapeutics00:09:16This novel medicine will represent an important addition to the clinical armamentarium, as there is a need for treatments beyond statins and ahead of the expensive injectables currently available. We are excited to leverage powerful operational and platform synergies with Pasipa to position HLS as the leader in delivering novel cardiovascular risk-reducing oral therapies to the Canadian market. Brian will provide more details on our launch preparations and the commercial opportunity, but I want to underscore that this launch represents a pivotal moment for HLS and will drive growth for years to come. Even as we set the stage for future growth, we plan to largely hold the line on operating expenses in 2026. As said previously, we've built a cost structure that can support both our existing portfolio and the new product launches without significant incremental investment. Craig MillianCEO at HLS Therapeutics00:10:17The financial foundation for HLS is solid, with improved profitability and cash flow. Our new credit agreement announced in the third quarter with favorable terms further strengthens our financial position. The agreement has a new syndicate of lenders and provides stability, lower interest expense, and greater flexibility to pursue strategic growth opportunities to expand our portfolio. With that, I'll turn it over to Brian to discuss our commercial performance and launch preparations. Brian? Brian WalshChief Commercial Officer at HLS Therapeutics00:10:52Thanks, Craig, and good morning, everyone. I'll walk through our Q3 and year-to-date product performance and provide an update on our bempedoic acid launch preparations. Starting with Clozaril, our U.S. Clozaril business has performed well, and year-to-date sales were up 1%. This is a meaningful improvement over the historical trend and is the result of a durable established patient base coupled with targeted new patient growth through our specialty pharmacy partnership. For Clozaril in Canada, as Craig noted, we continue to drive strong growth in the West, including 11% patient number growth in British Columbia. That was offset by expected patient attrition in Quebec and some competitive pressures at select accounts in Ontario. Brian WalshChief Commercial Officer at HLS Therapeutics00:11:38While we have experienced some unit impact from the pressures in Ontario, we have successfully defended our value proposition in the vast majority of accounts while maintaining our net pricing integrity, which preserves the foundation for a healthy, sustainable business moving forward. Despite these pressures, our patient numbers are down less than 1% at the end of Q3 versus the same time last year and up 1% versus the end of 2023, demonstrating the solid fundamentals underpinning our Clozaril franchise in Canada. Importantly, Clozapine is significantly underutilized across Canada as the only approved product for treatment-resistant schizophrenia. This context creates multiple pathways for our team to bring the lifesaving Clozaril brand and our differentiated CSUN services to more patients across Canada. Looking at Pasipa, Q3 unit volume grew 22% compared to Q3 last year, and year-to-date unit growth was 24%. Brian WalshChief Commercial Officer at HLS Therapeutics00:12:44The key story with Pasipa this year has been our sales force rebuild following the Pfizer transition and ahead of our bempedoic acid launch. As Craig shared, we made many of these changes with the aim of strengthening our commercial capabilities for both Pasipa, but also before we launched bempedoic acid. As a result, throughout 2023, more than half of our territories were open for some period of time as we recruited and onboarded new representatives. At the end of Q3, we had reached full deployment across all territories, and we are very excited about the talents that we have attracted to join HLS. While everyone we hired is an experienced specialty sales representative, it still takes several months for a new representative to get fully trained and established with their new customers. Brian WalshChief Commercial Officer at HLS Therapeutics00:13:32We are seeing very good early signs that our new team members are becoming increasingly productive, which is evident by overall growth in new patient starts. For the first time this year, we grew new patient starts each month in the quarter versus the prior year. We are also seeing improved depth of prescribing by growing consistent prescribers 5% versus Q2 of this year and 29% versus Q3 of last year. We expect this growth to accelerate in the coming quarters as our transform sales team gains further traction, driving a more meaningful impact on our full year 2026. The fundamentals supporting Pasipa remain strong. The product remains prominent in the CCS treatment guidelines, and Pasipa maintains excellent formulary access across both public and private payers. We continue to take proactive steps to streamline the reimbursement process and improve retention rates for patients that are covered by private plans. Brian WalshChief Commercial Officer at HLS Therapeutics00:14:35Now let me turn to the exciting upcoming launch of bempedoic acid. As mentioned previously, Nexletol and NexleZed are the commercial product names used in the U.S., but we expect a variation in the brand name for the monotherapy once Health Canada approval is finalized. The monotherapy is a daily oral non-statin treatment containing the novel compound bempedoic acid. Its brand name in Canada will be Nilembo, which is aligned to the brand name in Europe. The second product is the fixed-dose combination of bempedoic acid with ezetimibe in a single daily pill, and in Canada, it will be marketed as NexleZed, the same name as in the U.S. What makes these products differentiated is they add a second completely independent pathway to cardiovascular risk reduction alongside Pasipa's unique mechanism. These new products address a very large addressable market focused on LDL cholesterol reduction. Brian WalshChief Commercial Officer at HLS Therapeutics00:15:35LDL is the ultimate biomarker for cardiovascular risk. It's integrated into every clinical guideline and physician practice pattern. 40% of at-risk patients and half of high-risk atherosclerotic cardiovascular disease patients in Canada do not achieve their CCS guideline-recommended LDL target. These elevated LDL levels put patients at significant risk of future catastrophic vascular events like myocardial infarction, stroke, and cardiovascular death. The unmet medical need is significant, and we estimate more than 500,000 Canadians could potentially benefit from these medicines. This gives us a clear, well-established entry point for these products into the Canadian cardiovascular system. The clinical profile of these products is very compelling for physicians, patients, and payers. Brian WalshChief Commercial Officer at HLS Therapeutics00:16:28We will launch Nilembo with the results from the CLEAR outcomes trial, a nearly 14,000-patient randomized double-blind cardiovascular outcome study that demonstrated meaningful reduction in major adverse cardiovascular events, or MACE, in patients unable to take recommended statin therapy. Nilembo and NexleZed provide a novel oral pathway for LDL lowering while being less likely to cause muscle-related side effects that limit statin adherence and can be used alone or in combination with other LDL-lowering therapies. In terms of clinical practice, physicians typically start patients with a statin, then add ezetimibe if additional LDL lowering is needed. If patients still aren't at goal, the current standard of care moves to PCSK9 inhibitors, which are injectable, expensive, and generally reserved for only the highest-risk patients. Brian WalshChief Commercial Officer at HLS Therapeutics00:17:25Nilembo and NexleZed slot in ahead of PCSK9s in this treatment algorithm, providing a simpler, lower-cost oral option for patients who need additional LDL lowering but aren't appropriate candidates for injectable therapy. Our pre-launch preparations have accelerated since last quarter. We're finalizing our dossiers for pricing and reimbursement discussions. Our medical teams, who have been established for several years with our KOLs on Pasipa, have started engaging with their customers on bempedoic acid story this summer, and they have been met with a high level of enthusiasm regarding the significant unmet need that the product addresses. On timing, we expect to hear from Health Canada in Q4, which would put us on track for a Q2 2026 commercial launch. By that time, we expect to have product available and to have achieved meaningful coverage with private insurers. Brian WalshChief Commercial Officer at HLS Therapeutics00:18:19Our engagement on the public reimbursement will continue throughout 2026, with the goal of achieving favorable provincial listing agreements beginning in 2027. The strategic synergies with Pasipa are significant. The Canadian Cardiovascular Society guidelines recommend both further LDL lowering for patients not at goal and consideration of Pasipa treatment for patients with elevated triglycerides as a marker of increased cardiovascular event risk. With our expanded portfolio, we'll be well-positioned as the Canadian leader in oral cardiovascular risk reduction, able to partner with physicians to address a much broader set of patients working to reduce their remaining risk. Our customer-facing teams are energized and ready to launch these new products. With that, I'll turn it over to John for the financial results. John? John HannaCFO at HLS Therapeutics00:19:11Thank you, Brian, and good morning, everyone. I'll focus my remarks on our Q3 and year-to-date financial performance, the continued strengthening of our balance sheet, and our capital allocation approach. Starting with revenue, total revenue for Q3 was CAD 13.5 million compared to $14.1 million in Q3 last year. Year-to-date revenue was CAD 40.3 million compared to CAD 41.1 million in the same period last year. Craig and Brian have already covered off the key factors impacting revenue for the quarter and the year. Excluding royalties, revenue from Canadian product sales in local currency and revenue from U.S. Clozaril sales were both up on a year-to-date basis by 2.3% and 1%, respectively. The timing of orders can impact quarterly results, and for this reason, we view year-to-date revenue as a more relevant measure of the comparison of year-over-year revenue performance. Royalty revenue was CAD 180,000 in Q3 compared to CAD 195,000 in Q3 last year. John HannaCFO at HLS Therapeutics00:20:27Royalty revenue comparisons have normalized here in Q3 2025 following the sale of the Zempezime royalty in Q2 2024. HLS has one remaining royalty interest. Foreign exchange continues to be a headwind when translating Canadian dollar sales to U.S. dollars for reporting purposes. Year-to-date, foreign exchange has negatively impacted consolidated revenue by approximately $0.8 million. On the expense side, we continue to demonstrate strong operational discipline, helping to drive increases in Adjusted EBITDA and cash flow. Q3 operating expenses comprising sales and marketing, medical regulatory and patient support, and G&A were down 22% compared to Q3 last year. Year-to-date, these expenses were down 20%. This performance reflects our focus over the past 12 to 18 months on operational efficiency and driving product profitability. Cost of sales have increased in the quarter and year-to-date periods, largely due to growth in unit volumes and net sales for Pasipa. John HannaCFO at HLS Therapeutics00:21:46As Craig mentioned earlier, Adjusted EBITDA growth in Q3 and the year-to-date period was strong, increasing 19% and 25%, respectively. Similar to the discussion on OpEx, this is due to our efforts to optimize operations and drive product profitability. I want to highlight the consistent improvement we've made in our profitability trajectory. As shown in the slide in our presentation, on a trailing 12-month basis, Adjusted EBITDA, excluding royalties, has shown consistent quarterly improvement since bottoming out in late 2023. Q3 continues this positive trend. As Craig mentioned, since Q3 2023, Adjusted EBITDA ex royalties has grown by 87%. For the third quarter, the direct brand contribution from Clozaril to Adjusted EBITDA was CAD 6.3 million, while the direct brand contribution from Pasipa was CAD 0.6 million. Year-to-date, contributions were CAD 19.2 million for Clozaril and CAD 0.7 million for Pasipa. John HannaCFO at HLS Therapeutics00:22:59Cash from operations in Q3 was CAD 2.5 million, up 67% compared to Q3 last year. Year-to-date, cash from operations was CAD 10.6 million, up 121% versus the same period last year. This strong operating cash flow performance reflects our improved profitability. Another driver of our cash flow improvement has been the reduction in interest expense. Year-to-date, we've reduced interest expense by 38%, saving $2.6 million. This reflects the significant progress we've made in paying down debt and lowering our effective interest rate. Turning to the balance sheet, at quarter end, the carrying amount of our term loans stood at CAD 53.1 million, down CAD 12.9 million, or 19%, from CAD 67.4 million at December 31, 2024, and down CAD 33.6 million, or almost 40%, since the end of 2023. As a result of our continued debt reduction, net debt stood at CAD 43.5 million at quarter end, compared to CAD 50 million at December 31, 2024. John HannaCFO at HLS Therapeutics00:24:11Our deleveraging, combined with our improved operational performance, has fundamentally strengthened our financial position and created greater flexibility for capital allocation. Further strengthening our financial position, in August, we successfully refinanced our debt facility, entering into a new Canadian-denominated credit agreement with total borrowing capacity of $107 million. National Bank of Canada is the lead, and the syndicate includes TD Bank, RBC, and Innovation Federal Credit Union. This replaces our previous U.S. dollar facility and extends our maturity to August 2029. The Canadian-denominated structure provides a natural hedge against our predominantly Canadian operations while reducing foreign exchange exposure. We've achieved meaningful interest rate savings of 25-50 basis points on spreads, plus over 100 basis points from favorable Canadian base rates. This should net us annual savings of approximately CAD 1.5 million in interest expense. This enhanced financial flexibility supports our capital allocation priorities. John HannaCFO at HLS Therapeutics00:25:25Our outlook for capital allocation remains balanced and is focused on 3 areas: 1, continued debt reduction, returning capital to shareholders through share buybacks, and 3, strategic portfolio expansion. Importantly, we've funded all 3 priorities: debt reduction, share buybacks, and portfolio expansion through operating cash flow without requiring additional financing. In summary, we're delivering on our profitability commitments, generating strong cash flow, and continuing to strengthen our balance sheet. We've built a solid financial foundation that provides flexibility to invest in our portfolio while also returning capital to shareholders. With that, I'll turn it back to Craig for closing remarks. Craig? Craig MillianCEO at HLS Therapeutics00:26:15Thank you, John. In closing, our consistently improving profitability demonstrates that the operational transformation we've executed is working. We're generating improved cash flow, significantly reducing our debt burden, and building a more sustainable cost structure that can also support growth. The pending approval of bempedoic acid will transform our cardiovascular franchise in Canada and further establish HLS as a leader in delivering novel oral therapies to reduce cardiovascular risk. We remain focused on execution and are confident that our strategy, our team, and our growing portfolio of important medicines will continue to deliver results and create value. That concludes our prepared remarks. At this point, I'll ask the operator to please provide instructions for asking questions. Operator? Moderator00:27:09Thank you. Ladies and gentlemen, we will now begin the question-and-answer session. To ask a question, you may press the star followed by the number 1 on your telephone keypad. If you're using a speakerphone, please speak up your headset before pressing the keys. To withdraw your question, please press the star followed by the number 2. With that, our first question comes from the line of Michael Freeman with Raymond James. Please go ahead. Michael FreemanResearch Analyst at Raymond James00:27:33Hey, good morning, everybody, and congratulations on all this progress. I think as a quick first one, I wonder if you could describe any interactions you've had with Health Canada on bempedoic acid. Craig MillianCEO at HLS Therapeutics00:27:51Thanks, Michael, for the question. I'll turn it over to Brian. Brian WalshChief Commercial Officer at HLS Therapeutics00:27:55Hey, Michael, good morning. You were progressing with the regulatory review. We've had very good engagement on bempedoic acid, and you were expecting to hear from them this quarter. We're on track for a product launch in Q2 of next year. Michael FreemanResearch Analyst at Raymond James00:28:14Okay. Okay. Now, on the Clozaril business, you described well some of these Canadian headwinds. I wonder what your overall plans are for maintaining or growing this business, I guess, broadly, but specifically in Canada. You have a very strong market share in Ontario that maybe competitors are nibbling away at, but there does seem to be quite a lot of headroom in other provinces in Canada. I wonder what your game plan is. Brian WalshChief Commercial Officer at HLS Therapeutics00:28:51Yeah. Yeah, it's a great question, Michael. That's where for this brand, given the significant underutilization of Clozaril, we see a lot of pathways to growth. Over the last couple of years, we've reported on significant growth, double-digit growth in the Western provinces. We still have less than a third of those markets, so we still see significant headroom, good profitability opportunities in those markets. We have been making subtle changes to shift resources to accelerate that growth. Even within Ontario, where there's some modest pressure, there's still significant population growth and growth opportunities throughout the province. Craig MillianCEO at HLS Therapeutics00:29:35Yeah. And just to add, even in Quebec, where you may recall a year or so ago, a little over a year, we actually changed our model there to really focus on patient retention due to some of the challenges in terms of acquisition of patients in Quebec. That has been a resounding success. We have been able to limit any sort of attrition in Quebec to low single-digit % and really patient-by-patient work to retain everyone of our patients. The stickiness of that patient population in Quebec is quite remarkable. Often when there is attrition, it is due to reasons such as a patient passing away, for example, not necessarily due to a switch. The strategy has worked in terms of maximizing our retention of patients in Quebec, defending our really dominant share in Ontario. Craig MillianCEO at HLS Therapeutics00:30:35We have fantastic relationships at the major accounts there, the major mental health institutions, and we think there are still opportunities to grow. Admittedly, it is certainly a competitive space. As Brian said, really a lot of headroom for growth out in the Western provinces. Michael FreemanResearch Analyst at Raymond James00:30:57I wonder if you could provide similar color on Clozaril in the U.S. Brian WalshChief Commercial Officer at HLS Therapeutics00:31:03Yeah. Very different dynamic. It's a very stable patient population, but a different share, lower share, higher value per patient. Our regular core business has been very stable. As accounts there, we tend to have more private pay patients. We've been able to offset some natural patient attrition through targeted growth through specialty pharmacy, where we're able to offer financial assistance and educational support programs. We continue to see that we've achieved, I think, a level of stability with that business, and we can see that continuing in the coming years. Michael FreemanResearch Analyst at Raymond James00:31:55Excellent. Now, last one for me. There was some mention of pursuing business development as a result of you guys strengthening your balance sheet. What should we expect in terms of sort of structure of in-licensing, perhaps, or size of deal? Would we expect something similar to what we saw with bempedoic acid, or are you scaling up your ambition? Craig MillianCEO at HLS Therapeutics00:32:29It's a good question. What I would say is, so we love the bempedoic acid deal, and obviously, there's other deals of that magnitude. We think this is going to create significant shareholder value. We think these are products that will generate tens of millions of dollars in revenue and, again, fit so beautifully with the infrastructure we already have in place and really building our positioning as a premier cardiovascular company in Canada. Obviously, the opportunity to continue to do deals like that are very attractive, albeit not necessarily an infinite number of those opportunities. I do think with the strengthening balance sheet and the new debt facility, that does, I'd say, widen the aperture in terms of the type of deals we can do. Craig MillianCEO at HLS Therapeutics00:33:22I think right now, our focus is on continuing to bring in assets that are materially significant, that will add significantly material revenues to our top line. We think that's very important. We're not interested in things that are too. Moderator00:34:09Excuse me, ladies and gentlemen. Please continue to stand by. Ladies and gentlemen, thank you for standing by. The presenter is now reconnected. Please go ahead. Craig MillianCEO at HLS Therapeutics00:35:32Apologies. We're in a meeting room at a hotel, and the Wi-Fi dropped here. I'm not sure when the call dropped. I know we had a question from Michael. Michael FreemanResearch Analyst at Raymond James00:35:45You're in the criteria. Craig MillianCEO at HLS Therapeutics00:35:46Yeah. Yeah. So I mean, I'll just be brief. The answer is yes. We're looking at deals, I think, similar in scope to what we've done, but I would say, again, with the strengthened balance sheet and with kind of the increased flexibility with the lending agreement, we're in a position, I think, to broaden the aperture. Looking at things that obviously fit with our model in Canada, and that can easily be broadened, but that have significant sales potential. Obviously, we'll be opportunistic as well. I think we're looking at opportunities to expand our business as well in the U.S., recognizing that those will be maybe challenging to identify. We're confident we can continue to build out our business there as well. Stay tuned. Craig MillianCEO at HLS Therapeutics00:36:38We're very active, and we're very committed to continuing to grow top line now that we've really put our financial house in order and have a cost structure that we think can support a lot more growth. Michael FreemanResearch Analyst at Raymond James00:36:54Okay. Thank you very much. I'll pass the line. Moderator00:37:00Thank you. If you would like to ask a question, simply press the star 1 on your telephone keypad. Your next question comes from David Martin with Bloomberg. Please go ahead. David MartinAnalyst at Bloomberg00:37:12Good morning. First question. The CEPA scripts were up 22% in third quarter year over year, but the net sales were up only 2.1% in local currency. You mentioned inventory fluctuations. I'm wondering, are you seeing inventories more stable or even some restocking post Q3? Are you also seeing pressure on your net pricing? Did that feed into it as well? Craig MillianCEO at HLS Therapeutics00:37:40Yeah. I don't know, John, if you want to comment on this. I mean, I would say that, and this has historically been the case, obviously the growth and demand outpacing growth in net sales. This is really an artifact of having launched first into the private markets and then subsequently launching into the public markets with the different economics of that. Over time, we went from 100% of our business being private to now a blend. The good news is now we're starting to see stabilization as we've expected. As we continue to grow in both segments, both channels, we continue to see more significant growth, I would say, on the public side. That does drive an increase in rebates. That certainly has some impact on gross to net. The goal has been to stabilize that payer mix. Craig MillianCEO at HLS Therapeutics00:38:43When that occurs, we believe we'll see a narrowing of that difference between demand growth and net sales growth, but we're not quite there yet. I think probably the largest explanation for that, David, is payer mix. I don't know, John, if there's any other elements that you would. John HannaCFO at HLS Therapeutics00:39:02No, I wouldn't correct that. I think you covered it well. We did comment a little bit on inventory for Clozaril for the CEPA. It's really sort of the routine wholesaler orders that our biggest wholesalers place big orders, and depending on where they drop. There was nothing significant to comment on there for the quarter. Craig MillianCEO at HLS Therapeutics00:39:22Yeah. There is lumpiness for certain in terms of order patterns, which is why we, especially with a limited number of products, any large order that takes place in 1 quarter versus another can influence year-over-year comparisons, which is why we tend to focus more on year-to-date versus quarter because there is that variability. David MartinAnalyst at Bloomberg00:39:45Okay. Was there a large order that got pushed from Q3 into Q4? Craig MillianCEO at HLS Therapeutics00:39:51No. As I say, nothing specific to this quarter. David MartinAnalyst at Bloomberg00:39:54Okay. For Clozaril, the growth out west, is that mainly coming from taking share from competitors, or are you seeing increasing overall usage of clozapine? Brian WalshChief Commercial Officer at HLS Therapeutics00:40:10It's both. We're population growth and utilization of clozapine, but our share has been increasing steadily as well. It's a population there, like other places in Canada, where there's this large installed population, and we're competing for the new starts. I think we're competing even ahead of our market share in that dynamic portion of the market. It's both we're winning more in the new start population, but we're seeing the overall, we're seeing utilization increase. David MartinAnalyst at Bloomberg00:40:47Okay. Great. Last question. You've obviously got good infrastructure to take on additional cardiovascular drugs. If you took on another psychiatry drug, would you need to build out your salesforce, or could that be layered onto the group you've got now? Brian WalshChief Commercial Officer at HLS Therapeutics00:41:08It would depend on the indication specifically. I think most of the opportunities on the neuroscience side would require some incremental build. We believe we still have capacity to bring in additional cardiovascular products within our existing footprint, just given the coverage and life cycle of the CEPA. Craig MillianCEO at HLS Therapeutics00:41:31Yeah. We definitely have capacity, we believe, on the cardiovascular side. That'll certainly continue to be a focus. We think we've got a really, now with the upgrade in the salesforce and bringing on some super talented folks, a really strong customer-facing organization in addition to our medical team. Similarly, on the Clozaril side, we have a very strong multidisciplinary team. As Brian said, there's some really strong foundational elements to that team, which gives us the versatility to bring in a range of products that we could then adapt accordingly. That would require most likely some additional salespeople. We have a fairly light footprint. David MartinAnalyst at Bloomberg00:42:20Okay. Thank you. Moderator00:42:24Thank you. We have no further questions at this time. I would like to turn it back to Craig Millian for closing remarks. Craig MillianCEO at HLS Therapeutics00:42:32Thank you, operator. Thank you all for participating on today's call. We look forward to reporting to you on progress in the coming quarters and speaking with you again soon. Thanks. Have a great morning. Moderator00:42:47Thank you, presenters. Ladies and gentlemen, this concludes today's conference call. Thank you all for joining me now. This con.Read moreParticipantsExecutivesCraig MillianCEOJohn HannaCFOBrian WalshChief Commercial OfficerDavid MasonInvestor RelationsAnalystsModeratorMichael FreemanResearch Analyst at Raymond JamesDavid MartinAnalyst at BloombergPowered by