Theratechnologies Inc.

Good morning, ladies and gentlemen, and thank you for standing by. Welcome to Thera Technologies' first quarter 2025 earnings call. We would like to remind everyone that all figures on this call are quoted in U.S. dollars. At this time, all participants are in a listen-only mode. Following the presentation, we will conduct a question and answer session with analysts. Instructions will be provided at that time for you to queue up for questions. Following the analyst Q&A session, Investors wishing to submit a question may do so by clicking the Ask a Question link on the webcast platform. If anyone has any difficulties hearing the conference, please press the star key followed by zero for operator assistance at any time. I would like to remind everyone that this conference call is being recorded today, Wednesday, April 9, 2025 at 8.30 a.m. Eastern Time. I will now turn the call over to Joanne Choi, Senior Director, Investor Relations at Thera Technologies. Joanne, please go ahead.

Thank you, Drew. Good morning, and thank you for joining Thera Technologies' first quarter 2025 earnings call. On today's call, we are joined by Paul Levesque, Thera Technologies President and Chief Executive Officer, and Philippe Dubuc, Senior Vice President and Chief Financial Officer. After the prepared remarks, we will open up the call for your questions where we will be joined by Dr. Christian Marsolais, Senior Vice President and Chief Medical Officer, and John Leisure, the company's Global Commercial Officer. Before we begin, I'd like to remind everyone that today's remarks contain forward-looking statements within the meaning of securities laws, including our business and financial outlook. Actual results may differ materially from historical performance and those forward-looking statements implied herein. These statements together with the assumptions Underlying them and the risks related thereto are outlined in detail in the forelooking information section of their technologies and DNA issued this morning and available on CEDAR Plus and on EDGAR. Forelooking statements represent their technologies expectations as of this morning, April 9, 2025. Additionally, the company, using the term adjusted EBITDA, which is Not a financial measure under IFRS or U.S. Generally Accepted Accounting Principles U.S. GAAP. Adjacent EBITDA excludes the effects of items that primarily reflect the impact of long-term investment and financing decisions rather than the results of day-to-day operations. Thera Technologies believes that this measure can be a useful indicator of its operational performance and financial condition from one period to another. The company uses this non-IFRS measure to make financial, strategic, and operating decisions. Reconciliation of adjusted EBITDA to net loss is found in our MD&A issue this morning, as well as on CEDAR Plus and EDGAR, as mentioned earlier. Thank you. I will now turn the conference over to our CEO.

Paul? Thank you, Joanne, and good morning, everyone. I'm pleased to report on our fiscal first quarter and the ending quarter. February 28th, with total revenues of $19 million, representing 17% growth from the same period last year. The strong performance on a relative basis was driven by the strength of our lead asset, the Grifta SV, which continues to carry the best momentum we have seen since its market introduction. There are two main reasons for this. First, excess special abdominal fat, or EVAP, is increasingly being recognized by the medical community as a potentially serious condition requiring attention and treatment. There's also strong supporting evidence linking EVAP with increased cardiovascular risk and metabolic disease, which I will expand upon a bit more on the call shortly. This, coupled with our specialized field force focused on community education and product differentiation, has truly been the driving force behind this uptake. This brings me to the recent approval of our F8 formulation of Tesam Morlin. We are absolutely thrilled to be bringing this new and improved formulation to the market, where it will continue to remain our engine of growth for years to come. A Gryphna WR comes with a host of new benefits for patients. To start, this new formulation only requires a once-weekly reconstitution as opposed to daily, which is a material enhancement designed with patients in mind for a simpler and less cumbersome administration. The F8 formulation requires a smaller volume of administration and comes with a smaller syringe and needle than the current F4 formulation. And finally, in developing this new formulation, we conducted a very thorough human factor study. This substantial investment resulted in crystal clear instruction for use for the patient. We are very confident that this new and improved formulation will lead to better patient experience, adherence, and duration of treatment. As you recall, we resumed distribution of Egrifta SV in mid-February following a temporary drug shortage that began in early January, which resulted in a sales loss of six to seven weeks. Fortunately, new and returning patients were able to fill their scripts within one or two weeks after supply was restored, and we are now fully back in business. With March patient data in, we're happy to report that our total number of unique patients is up year over year, indicating the base of patients is back on treatment. In addition, new enrollments were up 15% in the first quarter compared to last year. This speaks to the dedication and performance of our field force, who were able to successfully market the benefits of Agripta SV through that unfortunate period. Our teams are working hard to orchestrate a successful launch and effective transition from DF-4 to DF-8, which will be available in pharmacies beginning in July. Importantly, this week's approval of the prior approval supplement lifts any remaining uncertainty regarding supply. With ample SV on the market and additional batches in production and ready for shipment, we look forward to a seamless transition from a GRIFTA SV to a GRIFTA WR to be completed in early 2026. To further develop the strength of our HIV business, we recently presented data from the PROMIS-US and VAMA studies at CROI in March. The first poster featured data from the real-world observational registry PROMIS-US demonstrating the efficacy and safety of ibilizumab in reducing HIV to undetectable levels in heavily treatment-experienced patients with multidrug-resistant situations. Researchers presented an interim unmatched subgroup analysis comprising 112 participants. Results showed impressive reduction of viremia in patients whose regimens include ibelizumab despite having lower CD counts and higher viral loads at baseline than the non-ibelizumab control group. Ibelizumab was well tolerated with no infusion reaction and treatment emergent adverse events. Despite the advent of new therapies, multidrug resistance has persisted. As a result, there continues to be a need to establish and maintain virologic control, especially for people who are heavily treatment-experienced. These latest data suggest that ibilizumab is an indispensable agent for hard-to-treat patients and will continue to be used in combination with other long-acting injectables. We look forward to continuing to enroll patients in this first-of-its-kind registry. In the second poster, researchers from the Visceral Adiposity Measurement and Observation Study, or VAMUS, demonstrated that EVAP drives cardiovascular risk in patients with HIV. Investigators presented data highlighting the limitations of using BMI alone in assessing CV risk, particularly given the high CV risk observed in study participants with a normal or low BMI but high levels of EVAP. Traditionally, clinicians have used BMI as a marker to assess the risk of cardiovascular disease and other comorbidities in this population, but have often overlooked the importance of EVAP. These findings underscore that if healthcare providers focus solely on BMI, a sizable population of normal weight and overweight individuals with HIV, EVAP, and high CV risk will be missed. We hope this study encourages the use of simple and more precise tools for assessing EVAP, such as measuring waist circumference as a proven means to identifying people with HIV who are at risk of cardiovascular disease. Shifting over to business development, I want to start by sharing our approach to capital allocation in light of our new business strategy. With the drug shortage now behind us, our HIV business remains strong from a demand perspective, and we're now on the brink of generating meaningful cash flow supported by our new operating structure. When thinking about long-term value creation, we made the strategic decision to commit ourselves to increasing the bottom line of this organization. This means that we will remain prudent in our span to execute on the plan expansion of our portfolio through acquisitions and in-licensing of late-stage products. Central toward philosophy is to invest in the opportunities that offer the highest return on investment. This is why we are prioritizing products where we will have the ability to derive meaningful synergies from our current infrastructure, so that our top line will continue to outpace our expenses. In conjunction, we continue to make progress with the launches of Alizarcin and Danidalorcin in Canada with preparations for filing to be submitted later this year. Finally, on oncology, we continue to engage with potential partners. Oncology is all about discovering new targets, particularly in advanced cancers. Our sort one platform is, in of itself, an innovative technology that can have applications in many cancer treatments in the future. We will update you as development takes place. Before handing over the call to Philippe to review our first quarter performance in more detail, I would like to close with a few words on tariffs. We've been closely following the situation with tariffs and have mapped out our supply chains, particularly for Agrifta SV, which is pretty straightforward. While we cannot avoid any impact entirely, as our manufacturing process currently takes place both in the U.S. and Canada, we do not expect to be significantly impacted by tariffs should they be enforced. And with the approval of the F8 formulation, we will soon be moving 100% of our manufacturing to a new CDMO based in the U.S. With that, I will now turn over to Philippe to review our first quarter performance.