This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.

HLS Therapeutics Inc.
11/13/2025
Good morning and welcome to Q3 2025 Financial Results Conference Call for HLS Terfutics. At this point, I would like to turn the call over to David Mason, Investor Relations, for the introductory remarks. Please go ahead.
Thank you. Good morning, everyone, and thank you for joining us today. With me on the call is Craig Millian, Chief Executive Officer, John Hanna, Chief Financial Officer, and Brian Walsh, Chief Commercial Officer. Earlier this morning, we issued a news release announcing our financial results for the three and nine months ended September 30, 2025. This news release, along with our MD&A and financial statements, is available on HLS's website and on CDAR+. Please note that slides accompanying today's call can be viewed by the webcast, a link to which is available in our earnings press release and at our website on the events and presentations page. Certain matters discussed in today's conference call or answers that may be given to questions could constitute forward-looking statements. Actual results could differ materially from those anticipated. Risk factors that could affect results are detailed in the company's annual information form, which has been filed on CDAR+. 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 CDAR Plus and on our website. Please note that all financial information provided is in U.S. dollars unless otherwise specified. I would now like to turn the meeting over to Mr. Million. Please go ahead. Thanks, Dave.
Good morning, everyone, and thank you for joining us. On our call today, I'll review quarterly and year-to-date highlights, along with progress against corporate priorities. Brian will go into further detail on product performance, along with an update on launch preparations. And then John will follow with a detailed look at the numbers. Following John will hold a Q&A session. I want to start by highlighting the progress we've made over the past two years, improving profitability and cash flow, and strengthening our financial position. We believe these improvements were essential to set the stage for future growth. I'll start with adjusted EBITDA, which was $4.9 million in the third quarter, up 19% year-over-year, and $13.9 million year-to-date, up 25% over the same 2024 period. With the progress we've made year-to-date, we are on track to reach our target adjusted EBITDA range for the full year. Following an inflection point two years ago, in the third quarter of 2023, we've demonstrated steady quarterly improvement in adjusted EBITDA, excluding royalties. And in the third quarter, we continued that positive trend. In that two-year window, adjusted EBITDA, excluding royalties, has increased by more than 85%. This performance is a result of the operational improvements we've made over the past couple of years. focusing on the key performance drivers for our promoted products, while significantly reducing operating expenses and de-levering our balance sheet. Financial discipline we've instilled across the organization is generating results, with strong operating cash flow and continued debt reduction. Don will provide more details on our financial position in his section. On the revenue side, while Canadian product sales have grown 2% year-to-date in local currency, we have faced several headwinds throughout 2025. And in the third quarter, revenues were down 4%. Let's start with BSEPA. With an eye towards strengthening commercial capabilities for both BSEPA and ahead of the Femfidoic Acid launch, we made substantial and purposeful changes to the sales force this year. In 2025, more than half of our territories turned over as we proactively recruited, upgraded, and onboarded new talent. Those geographies are now filled with highly experienced and motivated sales representatives who are building momentum in their territories. With a fully deployed customer-facing organization, this completes the transition that began late last year with our exit from the Pfizer Promotional Services Agreement. Even with the scope of these changes, the SEPA has managed to grow prescriptions at a substantial rate of 24% year-to-date, and the third quarter was its most profitable quarter since launch. That said, the SEPA prescription growth is below the ambition we set for the year. Based on year-to-date results, we now expect the SEPA revenue growth on a percentage basis in the mid-teens for the full year on a local currency basis compared to our prior range of 18% to 26% growth. We are optimistic that with a fully trained and deployed sales team, we will continue to grow the SEPA in 2026 and beyond. Turning to Clozaril, we had an ambitious plan to grow our patient numbers this year across Canada. And while we still see many targeted growth opportunities ahead, they are taking longer to realize than anticipated. We have adjusted our guidance and now projected a decline of 4% to 5% for the Canadian clausural business and local currency for the full year. We estimate that about a third of the projected revenue decline is due to fluctuations in inventory at some hospital-based accounts, which had the effect of shifting revenue into 2024. We expect these inventory effects to impact 2025 comparisons to 2024, but not beyond. Plaza also recently faced increased competitive pressure in Ontario, where we maintain a very high market share. Earlier this year, a number of hospital accounts in Ontario were in play due to a large buying group contract that was up for a multi-year renewal. We successfully defended the vast majority of clausural business in Ontario, where a satisfied patient base, differentiated CSUN services, and innovative pronto offering helped support the clausural value proposition. Despite the increased competitive activity in Ontario, overall clausural patient numbers in Canada are down less than 1% versus prior year, and this is due to sizable gains we have achieved in other parts of the country, particularly the western provinces. Taking a slightly longer view, clausural patient numbers in Canada are actually up about 1% since the end of 2023. In addition, our U.S. collateral business has shown resilience and is currently outperforming expectations for the year. This stable U.S. performance represents a meaningful improvement over the historical trend. So, to summarize our outlook for the rest of the year, profitability remains strong, and we expect to grow adjusted EBITDA to meet our guidance range of 17% to 23% growth, which translates to $19.5 to $20.5 million. Based on our updated product sales guidance, we are now providing a consolidated revenue estimate for the year of $55 to $56 million. Looking toward 2026, we expect to grow both top line and adjusted EBITDA next year. Although we saw some recent increased competitive activity against Clauseril and Ontario, we have successfully grown our existing patient base over the past two years and expect business to stabilize in Canada. For Vesipa, now that our sales force is fully staffed, we're starting to see the positive impact, including recent increases in new to brand patients. This makes us optimistic for growth prospects. And of course, we're preparing to expand our cardiovascular portfolio with a second quarter launch of benfidoic acid, which will contribute to revenue in 2026. We'll provide a more detailed financial outlook for 2026 when we issue our year-end results in March. While we manage the near-term objective of profitably growing our existing product portfolio, I want to emphasize how excited we are about the growth opportunity ahead of us as we build HLS into a leading cardiovascular company in Canada. The introduction of bemidoic acid will help address a large and growing patient population of more than half a million Canadians who could benefit from additional LDL cholesterol lowering. This novel medicine will represent an important addition to the clinical armamentarium as there is a need for treatments beyond statins and ahead of the expensive injectables currently available. And we are excited to leverage powerful operational and platform synergies with BCIPA to position HLS as the leader in delivering novel cardiovascular risk-reducing oral therapies to the Canadian market. Brian will provide more details on our launch preparations and the commercial opportunity. But I want to underscore that this launch represents a pivotal moment for HLS and will drive growth for years to come. Even as we set the stage for future growth, we plan to largely hold the line on operating expenses in 2026. As said previously, we've built a cost structure that can support both our existing portfolio and the new product launches without significant incremental investment. The financial foundation for HLS is solid with improved profitability and cash flow. Our new credit agreement announced in the third quarter with favorable terms further strengthens our financial position. The agreement has a new syndicate of lenders and provides stability, lower interest expense, and greater flexibility to pursue strategic growth opportunities to expand our portfolio. With that, I'll turn it over to Brian to discuss our commercial performance and launch preparations. Brian?
You're reading a preview of the HLS Q3 2025 earnings call.
Free account.