Q2 2026 HLS Therapeutics Inc Earnings Call
Speaker #1: Good 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.
Operator 2: Good morning, and welcome to the Q2 fiscal 2026 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.
Operator: Good morning, and welcome to the Q2 fiscal 2026 financial results conference call for HLS Therapeutics. At this point, I would like to turn the call over to David Mason, Investor Relations Officer, for the introductory remarks. Please go ahead.
Speaker #1: Please go ahead.
Speaker #2: Good 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.
Dave Mason: Good 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 30 June 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.
David Mason: Good 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 Commercial Officer. Earlier this morning, we issued a news release announcing our financial results for the three and six months ended 30 June 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.
Speaker #2: Earlier this morning, we issued a news release announcing our financial results for the 3 and 6 months ended June 30, 2026. This news release along with our MD&A and financial statements is available on our website and on Cedar Plus.
Speaker #2: 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.
Speaker #2: 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.
Speaker #2: Risk factors that could affect results are detailed in the company's annual information form, which has been filed on Cedar Plus. During the call, we will refer to adjusted EBITDA, adjusted EBITDA does not have any standardized meaning prescribed by IFRS.
Dave Mason: Risk factors that could affect results are detailed in the company's annual information form, which has been filed on SEDAR+. During the call, we will refer to Adjusted EBITDA. Adjusted EBITDA does not have any standardized meaning prescribed by IFRS. Adjusted EBITDA is defined in our press release and annual filings that are available on SEDAR+ and on our website. Please note that all financial information provided is in USD unless otherwise specified. I would now like to turn the meeting over to Mr. Millian. Please go ahead.
David Mason: Risk factors that could affect results are detailed in the company's annual information form, which has been filed on SEDAR+. During the call, we will refer to Adjusted EBITDA. Adjusted EBITDA does not have any standardized meaning prescribed by IFRS. Adjusted EBITDA is defined in our press release and annual filings that are available on SEDAR+ and on our website. Please note that all financial information provided is in USD unless otherwise specified. I would now like to turn the meeting over to Mr. Millian. Please go ahead.
Speaker #2: Adjusted EBITDA is defined in our press release and annual filings that are available on Cedar Plus and on our website. Please note that all financial information provided is in US dollars unless otherwise specified.
Speaker #2: I would now like to turn the meeting over to Mr. Millian. Please go ahead.
Speaker #3: Thanks, 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.
Craig Millian: Thanks, Dave. Good morning, everyone, and thank you for joining us today. On our call today, I'll take you through our Q2 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, and 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 Q2 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 the business is stabilizing.
Craig Millian: Thanks, David. Good morning, everyone, and thank you for joining us today. On our call today, I'll take you through our Q2 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, and 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 Q2 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 the business is stabilizing.
Speaker #3: Brian will then follow with a closer look at each of our products, John will cover the financials in detail, and then I'll be back with a few closing thoughts before we open it up for questions.
Speaker #3: 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.
Speaker #3: Driven by double-digit placebo growth, along with a strong first quarter of sales for newly launched Nalendo. At the same time, our collateral patient base in Canada has grown sequentially for five consecutive months, including July.
Speaker #3: This is a positive sign that business is stabilizing. HLS 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.
Craig Millian: HLS 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 Q2 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 Millian: HLS 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 Q2 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.
Speaker #3: 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.
Speaker #3: The cardiovascular portfolio led the way with a 25% increase in net sales, in both local and reporting currency. PLENVU net sales grew 18%, which was a slight improvement over the strong growth it had in the first quarter.
Speaker #3: And Nalendo, 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, given that meaningful private payer coverage only started to take effect late in the quarter.
Speaker #3: In addition, as we announced last week, Nalendo has now secured reimbursement with the largest private payers in Canada, and achieved a unanimous recommendation for public reimbursement from Canada's drug agency.
Craig Millian: In 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 Q2 of last year in both local and reporting currency, a further positive sign that the business is stabilizing. In the US, Q2 Clozaril net sales were down versus the prior year and are down about $600,000 year to date.
Craig Millian: In 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 Q2 of last year in both local and reporting currency, a further positive sign that the business is stabilizing. In the US, Q2 Clozaril net sales were down versus the prior year and are down about $600,000 year to date.
Speaker #3: Brian will take you through greater detail on the Nalendo launch and the near-term catalyst on the horizon. Turning to CLOLATERA, in Canada, the trend we highlighted last quarter continued, with consistent monthly gains in the base of patients on branded CLOLATERA.
Speaker #3: 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.
Speaker #3: In the US, Q2 collateral net sales were down versus the prior year, and are down about 600,000 year to date. This is in part due to a slight decrease in demand, but it also reflects a challenging year-over-year comparison, as the second quarter of last year accounted for 28% of full-year US collateral sales.
Craig Millian: This is in part due to a slight decrease in demand, but also reflected a challenging year-over-year comparison as the Q2 of last year accounted for 28% of full-year US Clozaril sales. We expect a relatively flat year-over-year sales comparison for US Clozaril for the H2 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 H1 launch investment in NILEMDO. As we are 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 Millian: This is in part due to a slight decrease in demand, but also reflected a challenging year-over-year comparison as the Q2 of last year accounted for 28% of full-year US Clozaril sales. We expect a relatively flat year-over-year sales comparison for US Clozaril for the H2 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 H1 launch investment in NILEMDO. As we are 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.
Speaker #3: We expect a relatively flat year-over-year sales comparison for US collateral 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 Nalendo.
Speaker #3: As we're now seeing the expected uptick in revenue growth driven by the Nalendo launch, we expect margin expansion for our cardiovascular portfolio in the coming quarters.
Speaker #3: Even with the incremental investment to launch Nalendo, and with only one full quarter of sales, the direct brand contribution from our cardiovascular portfolio is break-even for the year.
Speaker #3: And that brings me to capital allocation. Over the past couple of years, we set out to put HLS on a stronger financial footing. And that work is largely done.
Craig Millian: Over the past couple years, we set out to put HLS on a stronger financial footing, and that work is largely done. We have successfully de-levered 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 Millian: Over the past couple years, we set out to put HLS on a stronger financial footing, and that work is largely done. We have successfully de-levered 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.
Speaker #3: 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.
Speaker #3: 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.
Speaker #3: And on the growth side, we continue to pursue business development opportunities that are consistent with our strategic focus, organizational capabilities, and financial resources. HLS is highly regarded as a potential partner in Canada based on our capabilities and customer relationships and specialty therapeutic areas.
Craig Millian: HLS 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 have 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 to $60 million and Adjusted EBITDA of $18.5 to $21 million. Consistent with the quarterly gating we outlined last quarter, we expect year-over-year Adjusted EBITDA comps to improve in the H2 of the year as the cardiovascular portfolio revenue continues to ramp. With that, let me hand things over to Brian.
Craig Millian: HLS 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 have 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 to $60 million and Adjusted EBITDA of $18.5 to $21 million. Consistent with the quarterly gating we outlined last quarter, we expect year-over-year Adjusted EBITDA comps to improve in the H2 of the year as the cardiovascular portfolio revenue continues to ramp. With that, let me hand things over to Brian.
Speaker #3: Our intent is to bring in assets at a reasonable cost that can meaningfully grow the top line, or a creative in the near term, and allow us to more fully leverage the infrastructure we've built in Canadian specialty markets.
Speaker #3: 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.
Speaker #3: Revenue of 56 to 60 million dollars, and adjusted EBITDA of 18.5 to 21 million dollars. Consistent with the quarterly gating we outlined last quarter, we expect year over year adjusted EBITDA comps year over year adjusted EBITDA comps to improve in the second half of the year as the cardiovascular portfolio revenue continues to ramp.
Speaker #3: With that, let me hand things over to Brian, and before I do, you may have noticed in Dave's introduction that Brian is now our chief operating officer.
Craig Millian: 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.
Craig Millian: 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.
Speaker #3: Brian has been an impactful leader since joining HLS three years ago, as chief commercial officer. And 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.
Speaker #3: Brian, over to you.
Speaker #2: Thanks, Craig. Good morning, everyone. I'll take you through the portfolio this morning, starting with our cardiovascular growth drivers, placebo and Nalendo, then collateral in Canada, and the US.
Brian Walsh: Thanks, Craig. Good morning, everyone. I will take you through the portfolio this morning, starting with our cardiovascular growth drivers, VASCEPA and NILEMDO, then Clozaril in Canada and the US. 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 is 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 rider 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.
Craig Millian: Thanks, Craig. Good morning, everyone. I will take you through the portfolio this morning, starting with our cardiovascular growth drivers, VASCEPA and NILEMDO, then Clozaril in Canada and the US. 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 is 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 rider 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.
Speaker #2: Starting with placebo, net sales grew 18% in Q2 year over year, and units grew 16%. Year to date, net sales grew 14%, and units grew 17%.
Speaker #2: 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 the writer base, not just deepening it, and payer mix remains stable, supporting brand profitability.
Speaker #2: With patent protection through the late 2030s, Placebo remains a durable growth driver in its seventh year on the market and will become an increasingly meaningful contributor to margins going forward.
Speaker #2: Now to Nalendo, which completed its first full quarter on the market. Net sales were ahead of forecasts, with wholesaler reorders continuing and the weekly X-factory run rate strengthening as the quarter progressed.
Brian Walsh: Net sales were ahead of forecast, with wholesaler reorders continuing and the weekly ex-factory run rate strengthening as the quarter progressed. I have shared previously the enthusiasm that prescribers across Canada have shown for NILEMDO. Many reported having created lists of their patients that they have 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 three and a half 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.
Craig Millian: Net sales were ahead of forecast, with wholesaler reorders continuing and the weekly ex-factory run rate strengthening as the quarter progressed. I have shared previously the enthusiasm that prescribers across Canada have shown for NILEMDO. Many reported having created lists of their patients that they have 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 three and a half 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.
Speaker #2: I've previously shared the enthusiasm that prescribers across Canada have shown for Nalendo. Many have reported creating lists of patients they've pre-identified for this therapy.
Speaker #2: In Q2, we witnessed this excitement translate to action, where at the end of Q2, prescribers had started nearly 1,200 new patients on Nalendo, as measured by new-to-brand RX, or NBRX.
Speaker #2: For comparison, this is about 3.5 times greater than where placebo 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.
Speaker #2: On that front, private payer access is running ahead of our plan. As we announced on August 5th, we have now secured reimbursement with the largest private payers in Canada, representing approximately 80% of privately insured Canadians.
Brian Walsh: As we announced on 5 August, 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.
Craig Millian: As we announced on 5 August, 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.
Speaker #2: The vast majority of these patients can now access Nalendo as a full benefit without restrictions. Several of these agreements are already in effect with the remainder taking effect during the third quarter.
Speaker #2: On the public side, also announced, Canada's drug agency has finalized its reimbursement recommendation for Nalendo, with its expert committee voting unanimously to recommend reimbursement by participating public drug plans.
Speaker #2: 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.
Speaker #2: And on NexoZet, 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.
Brian Walsh: On NEXLIZET, the fixed-dose combination, we remain on track for a Health Canada decision by year-end, with launch to follow in H1 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.
Craig Millian: On NEXLIZET, the fixed-dose combination, we remain on track for a Health Canada decision by year-end, with launch to follow in H1 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.
Speaker #2: As we have described, Nalendo is a differentiated new entity—bempedoic acid—and it establishes the foundation. Once approved, NexoZet, which combines bempedoic acid with the commonly used lipid-lowering drug ezetimibe, will bring the combined benefits of both medicines to patients in one daily pill.
Speaker #2: NexoZet potentially gives us another important growth catalyst within 12 months. Turning now to collateral in Canada, our national patient base has now grown for five consecutive months through July.
Speaker #2: 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.
Speaker #2: The fundamentals are intact. The brand continues to hold about a 50% market share, and Collateral remains a strong, stable cash contributor. For Collateral in the U.S., as Craig noted, the year-over-year decline primarily reflects a comparatively large Q2 last year.
Brian Walsh: The brand continues to hold about a 50% market share, and Clozaril remains a strong, stable cash contributor. For Clozaril in the US, as Craig noted, the year-over-year decline primarily reflects a comparably large Q2 last year. The timing of the 4 July 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?
Craig Millian: The brand continues to hold about a 50% market share, and Clozaril remains a strong, stable cash contributor. For Clozaril in the US, as Craig noted, the year-over-year decline primarily reflects a comparably large Q2 last year. The timing of the 4 July 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?
Speaker #2: The timing of the July 4th holiday last year pulled some ordering into June, contributing to the outsize comparable. This remains a high-margin, cash-generating business, and we continue to look for ways to maintain patient volumes and expand, especially the pharmacy program.
Speaker #2: With that, I'll turn it over to John for a detailed look at our financials. John?
Speaker #3: Thank 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 US dollars, as per our reported numbers, unless otherwise noted.
John Hanna: Thank 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 USD 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. Clozaril net sales in the US were $3 million compared to $3.5 million in Q2 last year and were impacted by the factors discussed by Craig and Brian earlier.
John Hanna: Thank 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 USD 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. Clozaril net sales in the US were $3 million compared to $3.5 million in Q2 last year and were impacted by the factors discussed by Craig and Brian earlier.
Speaker #3: 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.
Speaker #3: Reflecting continued growth in placebo, and the first full quarter of net sales from Nalendo. Collateral net sales in Canada were down just 1% in local currency, versus Q2 last year, a significant improvement from Q1 comparables.
Speaker #3: Collateral 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.
Speaker #3: 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 Plenvu and initial sales of Nalendo.
John Hanna: 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 the NILEMDO launch. Q2 Adjusted EBITDA was $4.7 million, compared to $5.2 million in Q2 last year. Adjusted EBITDA was impacted by the NILEMDO launch investment, as just described. As we have discussed, we expect margins to improve for H2 of the year as NILEMDO revenue ramps.
John Hanna: 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 the NILEMDO launch. Q2 Adjusted EBITDA was $4.7 million, compared to $5.2 million in Q2 last year. Adjusted EBITDA was impacted by the NILEMDO launch investment, as just described. As we have discussed, we expect margins to improve for H2 of the year as NILEMDO revenue ramps.
Speaker #3: 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.
Speaker #3: Year to date, operating expenses were up 8%. The increases reflect our investment in Nalendo launch. Q2 adjusted EBITDA was $4.7 million, compared to $5.2 million in Q2 last year.
Speaker #3: Adjusted EBITDA was impacted by the Nalendo launch investment, as just described. As we have discussed, we expect margins to improve for the second half of the year as Nalendo revenue ramps up.
Speaker #3: 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.
John Hanna: 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 H1 dip followed by improving Adjusted EBITDA in the H2. 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. Turning 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.
John Hanna: 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 H1 dip followed by improving Adjusted EBITDA in the H2. 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. Turning 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.
Speaker #3: 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.
Speaker #3: For Q2, the direct brand contribution from Collateral to adjusted EBITDA was $6.7 million. For the year-to-date period, the direct brand contribution was $12.4 million.
Speaker #3: Turning 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.
Speaker #3: 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.
John Hanna: 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. From 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.
John Hanna: 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. From 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.
Speaker #3: 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.
Speaker #3: 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.
Speaker #3: From that, we first deduct royalty revenue, which is not core to our ongoing business, and then deduct net interest paid. What is left, as shown in the bars, is a view of the capital we have available to allocate on a trailing 12-month basis.
Speaker #3: 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.
John Hanna: 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. Put that all together, and what the core big 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'll turn to next.
John Hanna: 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. Put that all together, and what the core big 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'll turn to next.
Speaker #3: 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.
Speaker #3: At the same time, we stripped out considerable sales and marketing expense, while still growing the underlying business. Put 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.
Speaker #3: That combination is funding the capital priorities I'll turn to next. As Craig outlined, with the balance sheet work largely complete, our capital allocation priorities have shifted.
John Hanna: 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, and we have been active purchasers under the bid since inception. Through to 31 July, 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.
John Hanna: 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, and we have been active purchasers under the bid since inception. Through to 31 July, 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.
Speaker #3: Let me take each in turn. First, investing in growth. We have the flexibility to pursue business development outlined earlier. And we are well positioned to act when the right opportunity presents itself.
Speaker #3: 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. And we have been active purchasers under the bid since inception.
Speaker #3: Through to July 31st, we have repurchased approximately 340,000 shares, returning $1.4 million Canadian 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.
Speaker #3: Third, on debt, the heavy lifting of delivering 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.
John Hanna: In Q2, we made a principal repayment of USD 1.1 million. At 30 June 2026, the principal balance on our term loan stood at USD 42.2 million, down 16% from the end of 2025. Net debt stood at USD 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. Going forward, debt will continue to decline through scheduled amortization, with any additional payments made at our discretion. Finally, looking at balance sheet, cash was USD 13.7 million at quarter end, up from USD 11.7 million at the end of 2025. I would note that provisions rose to USD 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.
John Hanna: In Q2, we made a principal repayment of USD 1.1 million. At 30 June 2026, the principal balance on our term loan stood at USD 42.2 million, down 16% from the end of 2025. Net debt stood at USD 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. Going forward, debt will continue to decline through scheduled amortization, with any additional payments made at our discretion.
Speaker #3: And 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.
Speaker #3: This is the strongest balance sheet position we've been in for years, and that is what gives us the flexibility Craig described. Going forward, debt will continue to decline through scheduled amortization, with any additional payments made at our discretion.
Speaker #3: 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 rebate 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.
John Hanna: Finally, looking at balance sheet, cash was USD 13.7 million at quarter end, up from USD 11.7 million at the end of 2025. I would note that provisions rose to USD 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.
John Hanna: 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.
John Hanna: 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.
Speaker #3: In summary, the business is generating cash to fund both of our capital priorities simultaneously, while debt continues to decline through scheduled repayments. We are well positioned to act on the right business development opportunities as they arise, and with that, I'll pass it back to Craig for his closing comments.
Speaker #1: Thanks, John. Before we open it up to Q&A, three quick thoughts on the quarter and where we're headed. First, HLS is a fundamentally stronger company than at any time in my tenure.
Craig Millian: Thanks, 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 clozapine patient base is growing once again. Third, several catalysts are ahead of us. Private coverage for NILEMDO continues to ramp. With a favorable CDA recommendation, we will begin to pursue public reimbursement.
Craig Millian: Thanks, 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 clozapine patient base is growing once again. Third, several catalysts are ahead of us. Private coverage for NILEMDO continues to ramp. With a favorable CDA recommendation, we will begin to pursue public reimbursement.
Speaker #1: 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've begun returning capital to shareholders through a buyback.
Speaker #1: Second, the growth engine is starting to deliver. The cardiovascular portfolio grew approximately 25% this quarter. The SEPA is sustaining double-digit growth, and the LEMDO is ahead of plan with payer coverage expanding, and in Canada, the collateral patient base is growing once again.
Speaker #1: And third, several catalysts are ahead of us. Private coverage for LEMDO continues to ramp. With a favorable CADTH recommendation, we will begin to pursue public reimbursement.
Speaker #1: And next was that it 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.
Craig Millian: NEXLETOL remains on track for a Health Canada decision by year-end, followed by a H1 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 will ask our operator to please provide instructions for asking a question.
Craig Millian: NEXLETOL remains on track for a Health Canada decision by year-end, followed by a H1 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 will ask our operator to please provide instructions for asking a question.
Speaker #1: Our goal is to build scale in the coming years, both organically and through disciplined business development. This will increase operating leverage, broaden our reach with customers, and create greater value for shareholders.
Speaker #1: 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.
Speaker #2: Thank 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.
Operator 2: Thank 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 1 on your touchtone 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 2. 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.
Operator: Thank 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 1 on your touchtone 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 2. 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.
Speaker #2: If you wish to decline from the polling process, please press star followed by two. And if you are using a speakerphone, please lift the handset before pressing any keys.
Speaker #2: The first question comes from Michael Freeman with Raymond James. Please go ahead.
Speaker #4: Hey, good morning, Craig, John, Brian, and congratulations Brian on your new role. My first question here is, is on the SEPA. It really encourages to see this return to growth.
Michael Freeman: Hey, 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.
Michael Freeman: Hey, 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.
Speaker #4: 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 the LEMDO.
Speaker #4: While also having the SEPA in the bag.
Speaker #1: Yeah. Thanks, Mike, for the question. Brian?
Craig Millian: Yeah. Thanks, Mike, for the question. Brian, do you want to-
Craig Millian: Yeah. Thanks, Michael, for the question. Brian, do you want to-
Speaker #5: Hi, Michael. Good morning. Thank you. Yeah, great question. I think credit to the team. A lot of enthusiasm behind the LEMDO launch, but remaining focused on both products and the franchise.
Brian Walsh: Yeah. Hi, 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 our 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. The NILEMDO story has a very clear value proposition, and they can move through that in their details and create an opportunity to expand 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.
Craig Millian: Yeah. Hi, 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 our 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. The NILEMDO story has a very clear value proposition, and they can move through that in their details and create an opportunity to expand 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.
Speaker #5: One of our hypotheses with expanding the franchise was it creates more time in front of the customers, and we're seeing that. I'm seeing it firsthand, and our managers are reporting that back—that creating more absolute time for the SEPA in their interactions with customers, the LEMDO story, has a very clear value proposition, and they can move through that in their details and create an opportunity to expand on the benefits of the SEPA for cardiovascular reduction.
Speaker #5: We've talked in the past about how these are really synergistic in that way, and that we're talking largely to the same customers about a similar segment of patients in their practice.
Speaker #5: So, credit to the team. We're seeing that strengthening in Q2, and we're optimistic it continues through the rest of the year moving forward.
Brian Walsh: So to the team, we are seeing that strengthening in Q2 and optimistic it continues through the rest of the year moving forward.
Craig Millian: So to the team, we are seeing that strengthening in Q2 and optimistic it continues through the rest of the year moving forward.
Speaker #1: Yeah, and just maybe to add one additional point, I would say we've done a lot of work over the last couple of years, also kind of rebuilding the commercial organization.
Craig Millian: Yeah. 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 is ever been right now.
Craig Millian: Yeah. 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 is ever been right now.
Speaker #1: We've had some departures and some restructuring over the past couple of years, and I think the strength of our portfolio and bringing in new assets has really made HLS a desired destination for a lot of really strong talent.
Speaker #1: So we've been able to recruit both at the sales rep level and at the manager level—really experienced, talented professionals with extensive experience and relationships in cardiovascular.
Speaker #1: So I think the team is as strong as it's ever been right now.
Speaker #4: All right, all right. Thanks very much for that. Now, looking at the guidance, it looks like there's an implied acceleration in second-half EBITDA.
Michael Freeman: All right. Thanks very much for that. Now, looking at the guidance, it looks like there is an implied acceleration in H2 EBITDA. I wonder if you could help build the bridge from here to there, talk about the growth drivers of that H2 strength.
Michael Freeman: All right. Thanks very much for that. Now, looking at the guidance, it looks like there is an implied acceleration in H2 EBITDA. I wonder if you could help build the bridge from here to there, talk about the growth drivers of that H2 strength.
Speaker #4: I wonder if you could help build the bridge from here to there, talk about the growth drivers, of that second half strength.
Speaker #1: Sure. Yeah, I'll 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 the LEMDO in Q2, and we expect as Brian said, we're really encouraged by the week over week growth in X Factory sales.
Craig Millian: Sure. Yeah. 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. So 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.
Craig Millian: Sure. Yeah. 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. So 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.
Speaker #1: And 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.
Speaker #1: So I think if generally we're holding the line on the expense side and we expect to see some nice growth in continued growth and accelerated growth, quite frankly, on the cardiovascular side driven in large part by the LEMDO ramp, we expect to continue to see the growth in the SEPA that we've seen in the first half of the year.
Craig Millian: We expect to continue to see the growth in VASCEPA that we have seen in the H1 of the year, and we are really encouraged, Michael, by the sequential growth in patients on the Clozaril side, which suggests that, 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 H2 of the year. John, I do not know if you have anything to add there.
Craig Millian: We expect to continue to see the growth in VASCEPA that we have seen in the H1 of the year, and we are really encouraged, Michael, by the sequential growth in patients on the Clozaril side, which suggests that, 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 H2 of the year. John, I do not know if you have anything to add there.
Speaker #1: And we're really encouraged, Michael, by the sequential growth in patients on the cholesterol side, which suggests that—and as we predicted—as the year goes by, we'll see increasing stabilization on the cholesterol side as well.
Speaker #1: So I think, essentially, managing our costs responsibly—which is what we've, I think, established 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.
Speaker #1: John, I don't know if anything to add there.
Speaker #3: No, I think that's right. And 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 second half to the first half.
John Hanna: No, I think that is right, and in the H2 of the year as compared to the first 2 quarters, there will be a small decrease in the OpEx as compared to H2 to the H1. But primarily driven by what Craig had already outlined.
John Hanna: No, I think that is right, and in the H2 of the year as compared to the first 2 quarters, there will be a small decrease in the OpEx as compared to H2 to the H1. But primarily driven by what Craig had already outlined.
Speaker #3: But primarily driven by what Craig had already outlined.
Speaker #4: Okay, all right. Thank you very much. Congrats on the quarter. I'm going to pass it on.
Michael Freeman: Okay. All right. Thank you very much. Congrats on the quarter. I am going to pass it on.
Michael Freeman: Okay. All right. Thank you very much. Congrats on the quarter. I am going to pass it on.
Speaker #1: Thanks.
Speaker #5: Thanks, Michael.
Craig Millian: Thanks.
Brian Walsh: Thanks, Michael.
Michael Freeman: Thanks, Michael.
Speaker #4: Michael.
Michael Freeman: Michael.
Speaker #2: Thank you. Next question comes from Max Schmielewski with Staples. Please go ahead.
Operator 2: Thank you. Next question comes from Max Chmielewski with Stifel. Please go ahead.
Operator: Thank you. Next question comes from Max Chmielewski with Stifel. Please go ahead.
Speaker #4: Good morning, everyone. This is Max on for Justin. Next quarter, just the first question, on collateral I understand CSAN is historically been a pretty important tool in defending market share from generics.
Max Chmielewski: Good morning, everyone. This is Max on for Justin. Nice quarter. 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 are seeing more recently at the prescriber level as it relates to CSAN?
Max Chmielewski: Good morning, everyone. This is Max on for Justin. Nice quarter. 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 are seeing more recently at the prescriber level as it relates to CSAN?
Speaker #4: Can you maybe qualify what dynamics you’re seeing more recently at the prescriber level as it relates to CSAN?
Speaker #5: Yeah. 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.
Brian Walsh: Yeah. Hi, Max. Good morning. This is Brian Walsh. Thanks for the question. We are seeing, as you said, CSAN is an important differentiator for the Canadian business, Health Canada mandated registry, where we have seen across the country the differentiation play out. We have described previously some disruptions in Ontario, more from GPO contracts. As a result of CSAN, the services we provide, the Pronto device that is integrated as part of that program, we have 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 is 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.
Max Chmielewski: Yeah. Hi, Max. Good morning. This is Brian Walsh. Thanks for the question. We are seeing, as you said, CSAN is an important differentiator for the Canadian business, Health Canada mandated registry, where we have seen across the country the differentiation play out. We have described previously some disruptions in Ontario, more from GPO contracts. As a result of CSAN, the services we provide, the Pronto device that is integrated as part of that program, we have 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 is 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.
Speaker #5: 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 devices integrated as part of that program, we've seen large numbers of patients move to pharmacies where they can get branded collateral, move to different ways to stay on the brand.
Speaker #5: And that's driven by the support that community physicians have for brand over generic because of the services and the device. Likewise, in a lot of the growth in the West is driven by market share gains within the collateral team.
Speaker #5: So, taking share from generics largely because of that service. We've had smaller account, whole-account conversions in the West in Q2, which sets up encouragingly for the rest of the year as well.
Brian Walsh: We have 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.
Max Chmielewski: We have 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.
Speaker #5: And those are driven by the efforts of our team and the services that we provide on behalf of patients, again, with the devices an important part of that.
Speaker #1: Yeah, and we 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 that's a part of that is based on the resources we've brought to bear.
Craig Millian: Yeah. We find patients are incredibly sticky, unless they are forced to switch, which typically they are not, except in rare cases. For example, in Quebec, we have had a really strong retention rate, and that part of that is based on the resources we have brought to bear in our customer-facing model or 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 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.
Craig Millian: Yeah. We find patients are incredibly sticky, unless they are forced to switch, which typically they are not, except in rare cases. For example, in Quebec, we have had a really strong retention rate, and that part of that is based on the resources we have brought to bear in our customer-facing model or 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 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.
Speaker #1: 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.
Speaker #1: So we think the sweetest services that we provide around branded collateral has enabled us to maintain a very stable market share over extended period of time.
Speaker #1: And it certainly allowed us to weather some of these temporary disruptions that happen from time to time.
Speaker #4: That's great. Thank you. Switching gears, could you maybe describe the current status of payer mix for the SEPA and what growth you've seen in the public channel sales versus the last few quarters?
Max Chmielewski: That is great. Thank you. Switching gears, can you maybe describe the current status of payer mix for VASCEPA and what growth you have seen in the public channel sales versus the last few quarters?
Max Chmielewski: That is great. Thank you. Switching gears, can you maybe describe the current status of payer mix for VASCEPA and what growth you have seen in the public channel sales versus the last few quarters?
Speaker #1: John, do you want to take that question?
Craig Millian: John, do you want to take that question?
Craig Millian: John, do you want to take that question?
Speaker #3: Yeah, I would say the public share as we exited the last couple of quarters of 2025 was sort of in the just a shade over 50% range.
John Hanna: Yeah. 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 have progressed and seen some growth in 2026, we are moving up towards the 55% range. Probably through the year, we will stay in that high end of the 50% to 55% range.
John Hanna: Yeah. 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 have progressed and seen some growth in 2026, we are moving up towards the 55% range. Probably through the year, we will stay in that high end of the 50% to 55% range.
Speaker #3: And as we've progressed and seen some growth in 2026, we're moving up towards the 55% range. And probably through the year, we'll stay in that high end of the 50 to 55% range.
Speaker #1: Yeah, 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.
Craig Millian: Yeah. 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 have 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 have 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 have only been on listings for the last couple of years. The 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.
Craig Millian: Yeah. 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 have 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 have 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 have only been on listings for the last couple of years. The 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.
Speaker #1: So for example, Ontario and Quebec, have become quite stable. Which is good for us to be able to really kind of predict our growth to net.
Speaker #1: Where we've seen some continued expansion on the public side, which is as we expected, is in the provinces where we're more recently listed—those being British Columbia and Alberta, where I think we've only been on listings for the last couple of years.
Speaker #1: So the 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.
Speaker #1: I think, as John said, we're probably a shade beyond that. But still within range.
Craig Millian: I think as John said, we are probably a shade beyond that, but still within range.
Craig Millian: I think as John said, we are probably a shade beyond that, but still within range.
Speaker #4: Great. Thank you. And just one last question. 13, 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.
Max Chmielewski: Great. Thank you. Just one last question. 13, almost 14 million CAD in cash at the end of the quarter. As I understand it, somewhere in the range of 30 million CAD in revolver capacity. The balance sheet has 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 have recently made on NILEMDO, how would you expect the commercial infrastructure to need to look like with the addition of additional products within cardiovascular?
Max Chmielewski: Great. Thank you. Just one last question. 13, almost 14 million CAD in cash at the end of the quarter. As I understand it, somewhere in the range of 30 million CAD in revolver capacity. The balance sheet has 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 have recently made on NILEMDO, how would you expect the commercial infrastructure to need to look like with the addition of additional products within cardiovascular?
Speaker #4: So the balance sheet's been meaningfully improved. So well done on that front. Are you as you focus on the Lemdo 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 the Lemdo?
Speaker #4: How would you expect the commercial infrastructure to need to look with the addition of presumably additional products within cardiovascular?
Speaker #1: Yeah, that's a good question. So I think our focus, first of all, is executing with our core assets, no question. So that's job one.
Craig Millian: Yeah, that is a good question. I think our focus first of all is executing with our core assets, no question. So that is 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 Millian: Yeah, that is a good question. I think our focus first of all is executing with our core assets, no question. So that is 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.
Speaker #1: In parallel, we think we have the capacity to continue to be disciplined and thoughtful in terms of how we approach business development. So we are looking at we continue to screen assets very actively.
Speaker #1: And look at a lot of stuff; then they have to meet our criteria for what is sensible for us to add at this stage.
Speaker #1: Of our evolution. And we think there are attractive assets out there. I think good example is the deal we did with Asperion on the benzodiazepine acid.
Speaker #1: Assets. Wherever 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.
Craig Millian: Wherever possible, we strive to leverage the infrastructure we have built in Canada, both on the cardiovascular side and on the neuropsych side. 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. So we think we have got capacity. I think on a case-by-case basis, we will evaluate the return on investment of an expansion of infrastructure. So 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 will be well thought through and in a disciplined way, with an opportunity to very quickly generate a positive return.
Craig Millian: Wherever possible, we strive to leverage the infrastructure we have built in Canada, both on the cardiovascular side and on the neuropsych side. 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. So we think we have got capacity. I think on a case-by-case basis, we will evaluate the return on investment of an expansion of infrastructure. So 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 will be well thought through and in a disciplined way, with an opportunity to very quickly generate a positive return.
Speaker #1: So 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. So 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 the disciplined way.
Speaker #1: With an opportunity to very quickly generate a positive return.
Max Chmielewski: Wonderful. Thanks so much, guys.
Max Chmielewski: Wonderful. Thanks so much, guys.
Speaker #4: Wonderful. Thanks so much, guys.
Speaker #3: Thank you.
John Hanna: Thank you.
John Hanna: Thank you.
Speaker #2: Thank you. Next question comes from David Martin from Bloom Burton. Please go ahead.
Operator 2: Thank you. Next question comes from David Martin from Bloomberg. Please go ahead.
Operator: Thank you. Next question comes from David Martin from Bloomberg. Please go ahead.
Speaker #5: Good morning. When the SEPA was first launched, if I recall correctly, a material proportion of doctors waited to prescribe the drug until there was coverage for all patients.
David Martin: Good 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?
David Martin: Good 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?
Speaker #5: So, in other words, for privately insured patients, they didn't prescribe for them until public reimbursement was in place. Do you expect the same with Nalendo?
Speaker #6: Hi, David. Good morning. This is Brian. It's not an either-or. Obviously, with public reimbursement, it just creates a wide-open access picture. It makes it much easier for physicians to prescribe.
Craig Millian: Hi, 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 private patients in their practice.
Craig Millian: Hi, 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 private patients in their practice.
Speaker #6: I wouldn't say physicians intentionally wait, but it just becomes more nuanced for them to find those public patients. There are private patients in their practice.
Speaker #6: 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.
Brian Walsh: 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 unlimited and no restrictions, essentially. We're excited for that catalyst. We see it going into Q3 to accelerate, as Craig mentioned. But as 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 at that point.
Craig Millian: 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 unlimited and no restrictions, essentially. We're excited for that catalyst. We see it going into Q3 to accelerate, as Craig mentioned. But as 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 at that point.
Speaker #6: So physicians can identify at that level, and there's really not a lot on the private side, where we've landed with pretty broad coverage and limited, and no restrictions, essentially.
Speaker #6: So, we're excited for that catalyst we see going into Q3 to accelerate, as Craig mentioned. But as we go into next year, we expect to achieve public listings, and that will certainly make those conversations in the prescribing even easier for physicians and lift both sides at that point.
Speaker #1: Yeah, and I think launching Nalendo 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.
Craig Millian: Yeah. 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's a lot of those patients out there. This is a product that I think many of our physicians that we call on were eagerly anticipating this launch. 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've 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 Millian: Yeah. 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's a lot of those patients out there. This is a product that I think many of our physicians that we call on were eagerly anticipating this launch. 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've 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.
Speaker #1: And we know there's a lot of those patients out there. So this is a product that I think many of our physicians that we call and we're eagerly anticipating this launch.
Speaker #1: And I think that bears out in terms of the pretty rapid uptake that Brian described on new to brand. I think the SEPA required a little bit more and I've 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.
Speaker #1: And so that required, in some respects, a little bit more education in terms of exactly how to fit that in. And that's why I think we continue to see progress with the SEPA, even many years in, because I think the data are so robust. But it's also—we're creating a treatment paradigm with the SEPA that, frankly, already existed in a sense with benzodiazepine acid.
Craig Millian: And so that 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.
Craig Millian: And so that 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.
Speaker #5: When you say 'no restrictions,' I know that SEPA has significant restrictions on the public payer side of things. But is that differentiated on the private payer side?
David Martin: When you say no restrictions, I know VASCEPA has significant restrictions on the public payer side of things. But 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?
David Martin: When you say no restrictions, I know VASCEPA has significant restrictions on the public payer side of things. But 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?
Speaker #5: In other words, did the SEPA with private payers have restrictions that you're not seeing with Nalendo?
Speaker #6: Yeah, exactly, Dave. We estimate about half of patients on SEPA through our private coverage have a prior authorization to conform to the various criteria.
Brian Walsh: Yeah, exactly, David. 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. So 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. In turn, it just creates a bit of that element of a bit of a barrier.
David Martin: Yeah, exactly, David. 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. So 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. In turn, it just creates a bit of that element of a bit of a barrier.
Speaker #6: And we, at this point, with the private access we've achieved with Nalendo, that 80% is without the need for a prior authorization. So physicians know it's a full benefit and paid physicians can prescribe it without the need to do paperwork.
Speaker #6: So, the vast majority of patients should be able to go to the pharmacy and fill a script, whereas about half of patients with a SEPA would need to go through some paperwork process—which we support through our assistance program—but it is a barrier.
Speaker #6: It takes time. And physicians are busy to try to just create a bit of that element of a bit of a barrier.
Speaker #5: Great. And last question, if I can. The $300,000-plus of Nalendo sales, how much of that do you think was stocking in the channel?
David Martin: Great. Last question, if I can. The 300,000-plus of NILEMDO sales, how much of that do you think was stocking in the channel?
David Martin: Great. Last question, if I can. The 300,000-plus of NILEMDO sales, how much of that do you think was stocking in the channel? And should we expect a dip in Q2 as initially
Brian Walsh: Um-
Speaker #5: And should we expect a dip in the second quarter, as initial?
David Martin: And should we expect a dip in Q2 as initially
Brian Walsh: No, we see continued growth into the quarter. The channel build stays on-hand, so as we grow, they will continue to hold more. But we are seeing this through the IQVIA data. We are seeing the pull-through from actual prescriptions, the new-to-brand patients.
David Martin: No, we see continued growth into the quarter. The channel build stays on-hand, so as we grow, they will continue to hold more. But we are seeing this through the IQVIA data. We are seeing the pull-through from actual prescriptions, the new-to-brand patient's.
Speaker #6: No, we see continued growth into the quarter. The channel build stays on hand, so as we grow, they'll continue to hold more. But we're seeing this through the IQVIA data.
Speaker #6: We're seeing the pull-through from actual prescriptions—the new-to-brand patients. So the algorithms are pretty sophisticated at this point with the wholesalers.
David Martin: Yeah.
David Martin: Yeah.
Brian Walsh: The algorithms are pretty sophisticated at this point with the wholesalers and last mile to patients the next day. So they are not holding a lot of inventory. We are seeing this being demand-driven.
David Martin: The algorithms are pretty sophisticated at this point with the wholesalers and last mile to patients the next day. So they are not holding a lot of inventory. We are seeing this being demand-driven.
Speaker #6: And last mile, the patients the next day. So they're not holding a lot of inventory. We're seeing this being demand-driven.
Speaker #1: Yeah, there was no heavy initial stocking, as Brian said. The stocking builds as the demand grows, and the days on hand tend to be consistent.
Craig Millian: Yeah, there was no heavy initial stocking. As Brian Walsh 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. So 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 forecasts in general and raising them around NILEMDO. We expect Q3 to be much stronger than Q2, and then growing momentum as we head into 2027.
Craig Millian: Yeah, there was no heavy initial stocking. As Brian Walsh 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. So 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 forecasts in general and raising them around NILEMDO. We expect Q3 to be much stronger than Q2, and then growing momentum as we head into 2027.
Speaker #1: So we continue to see on a weekly basis increases in orders. So in other words, have weekly run rate in July, certainly is better than June, better than May.
Speaker #1: And now, we haven't even yet been able to really activate our teams around some of the new access wins that we have.
Speaker #1: So we are looking at our internal forecast and raising them around Nalendo. We expect the third quarter to be much stronger than the second quarter, and then growing momentum as we head into 2027.
Speaker #5: Okay, thanks. That's it for me.
David Martin: Okay, thanks. That is it for me.
David Martin: Okay, thanks. That is it for me.
Speaker #6: Thanks, Dave.
Brian Walsh: Thanks, David.
David Martin: Thanks, David.
Speaker #4: Thank you. The next question comes from Christopher Pugh with Canaccord. Please go ahead.
Operator 2: Thank you. The next question comes from Christopher Pugh with Canaccord. Please go ahead.
Operator: Thank you. The next question comes from Christopher Pugh with Canaccord. Please go ahead.
Speaker #7: Hey, good morning. Yeah, thanks for repeating my question. I'm on the line for Daniel right now. I know it's still early, but I'm interested to hear if you are seeing any cross-selling synergies with the SEPA for Nalendo?
Christopher Pugh: Hey, good morning. Yeah, thanks for taking my question. I am on the line for Tania right now. Considering it is still early, I am interested to hear on perhaps, are you seeing any cross-selling synergies with VASCEPA for NILEMDO, and are the sales force leveraging the existing relationships with the specialists to drive the trial of NILEMDO and any trends on perhaps through prescriptions?
Christopher Pu: Hey, good morning. Yeah, thanks for taking my question. I am on the line for Tania right now. Considering it is still early, I am interested to hear on perhaps, are you seeing any cross-selling synergies with VASCEPA for NILEMDO, and are the sales force leveraging the existing relationships with the specialists to drive the trial of NILEMDO and any trends on perhaps through prescriptions?
Speaker #7: And, like our kind of the Salesforce leveraging existing relationships with the specialists to drive the trial of Nalendo. And any trends on, perhaps, dual prescriptions?
Speaker #6: Sure. This is Brian. Thanks for the question. Exactly. That's one of our key drivers for this deal—the synergy, essentially, at the base of the customer between the SEP and the benzodiazepine acid franchise.
Brian Walsh: Sure. This is Brian. Thanks for the question. Exactly, and that's one of our key drivers for this deal is the synergy essentially at the base of the customer between VASCEPA and the bempedoic acid franchise. It's almost a complete overlap with the call point, the same customer base. We are seeing exactly that synergy you described. With VASCEPA, any product where you're going into year 6 or 7, it's 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. What I've seen and what our teams have reported is the NILEMDO story is straightforward. It fits a very established unmet need, as Craig described. We've created an access milieu which is very efficient and easy.
Christopher Pu: Sure. This is Brian. Thanks for the question. Exactly, and that's one of our key drivers for this deal is the synergy essentially at the base of the customer between VASCEPA and the bempedoic acid franchise. It's almost a complete overlap with the call point, the same customer base. We are seeing exactly that synergy you described. With VASCEPA, any product where you're going into year 6 or 7, it's 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. What I've seen and what our teams have reported is the NILEMDO story is straightforward. It fits a very established unmet need, as Craig described. We've created an access milieu which is very efficient and easy.
Speaker #6: It's almost a complete overlap with the call point, the same customer base. And so we are seeing exactly that synergy you described. The SEPA, any product where you're going into year six or seven, it's a little bit more difficult to bring new information.
Speaker #6: Our teams do the best every day to do that. And support patients. But bringing something new, exciting, creates an opportunity for more time in front of the customer.
Speaker #6: And what I've seen and what our teams have reported is the Nalendo story is straightforward. It fits the very established on that need as Craig described.
Speaker #6: We've created an access milieu, which is very efficient and easy, and so it's creating more time for the SEPA. As we went through the quarter, Q2, despite the loss in Nalandron, we saw an acceleration in new patients—new brand patients—for the SEPA.
Brian Walsh: It's creating more time for VASCEPA. As we went through the quarter in Q2, despite the loss of 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. We're excited to do so with NEXLIZET going into 2027 as well.
Christopher Pu: It's creating more time for VASCEPA. As we went through the quarter in Q2, despite the loss of 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. We're excited to do so with NEXLIZET going into 2027 as well.
Speaker #6: And we've seen that strong year-over-year growth. So those hypotheses are playing out, and we have a strong foundation as a franchise to build on.
Speaker #6: And we're excited to do so with Nexals going into 2027 as well.
Speaker #7: That's great to hear. I just got one last question regarding the expenses. So you mentioned that you're holding the line. On the expense side, so would it be fair to say that the Q2 was perhaps like peak spend on the S&M for Nalendo?
Christopher Pugh: That'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. Would it be fair to say that the Q2 was perhaps peak spend on the S&M for NILEMDO?
Christopher Pu: That'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. Would it be fair to say that the Q2 was perhaps peak spend on the S&M for NILEMDO?
Brian Walsh: Just-
Christopher Pu: Just-
John Hanna: I think that is-
John Hanna: I think that is-
Speaker #1: Yeah, John.
Brian Walsh: Go ahead, John.
John Hanna: Go ahead, John.
Speaker #2: Yeah, I think it's fair to say that it's likely the peak of the four quarters.
John Hanna: Yeah, I think that is fair to say that it's likely the peak of the four quarters.
John Hanna: Yeah, I think that is fair to say that it's likely the peak of the four quarters.
Speaker #1: Yeah, and 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.
Brian Walsh: Yeah, and 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. And so, 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. So that's a dynamic process. But on net, we're looking, obviously, to make sure we're maintaining our profitability, as John mentioned.
John Hanna: Yeah, and 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. And so, 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. So that's a dynamic process. But on net, we're looking, obviously, to make sure we're maintaining our profitability, as John mentioned.
Speaker #1: And so we look across the entire portfolio. So it may very well be, where we're generating growth with Nalendo, we might increase some investment there, but we'll look at other areas that we might be able to find some savings.
Speaker #1: So that's a dynamic process. But on net, we're obviously looking to make sure we're maintaining our profitability, as John mentioned.
Speaker #7: Okay, that's it for me. Thanks.
Christopher Pugh: Okay, that's it for me. Thanks.
Christopher Pu: Okay, that's it for me. Thanks.
Speaker #6: Thank ank you.
Brian Walsh: Thank you.
Christopher Pu: Thank you.
Speaker #4: Thank you. We have no further questions. I will turn the call back over to Craig Millian for closing comments.
Operator 2: Thank you. We have no further questions. I will turn the call back over to Craig Millian for closing comments.
Operator: Thank you. We have no further questions. I will turn the call back over to Craig Millian for closing comments.
Speaker #1: Great, thank you. And thank you all for participating on today's call. We look forward to reporting to you on our progress in the coming quarters.
Craig Millian: Great. 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.
Craig Millian: Great. 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.
Speaker #1: And speaking with you again soon. Bye. Goodbye, and have a great afternoon.
Operator 2: Ladies and gentlemen, this concludes your conference call for today. We thank you for participating, and we ask that you please disconnect your lines.
Operator: Ladies and gentlemen, this concludes your conference call for today. We thank you for participating, and we ask that you please disconnect your lines.
