Theratechnologies Inc.

Good morning, ladies and gentlemen, and thank you for standing by. Welcome to Thera Technologies' fourth quarter and fiscal year 2024 earnings call. We would like to remind everyone that all figures on this call are quoted in US dollars. At this time, all participants are in a listen-only mode. Following the presentation, we will conduct a question and answer session with the 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'd like to remind everyone that this conference call is being recorded today, Wednesday, February 23rd. 26, 2025, at 8.30 a.m. Eastern Time. I would now like to turn the conference call over to Joanne Choi, Senior Director, Investor Relations at TheraTechnologies. Joanne, please go ahead.

Thank you, Jamie. Good morning, and thank you for joining TheraTechnologies' fiscal fourth quarter and full year 2024 earnings call. On today's call, we are joined by Paul Levesque, TheraTechnologies' President and Chief Executive Officer, and Salif Dibouk, 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 Lazor, 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 financial and business outlook. Actual results may differ materially from historical performance and those forward-looking statements implied herein. These statements together with the assumptions underlying them are outlined in detail in the forward-looking information section of Thera Technologies Management's discussion and analysis issued this morning and available on CEDAR Plus and on EDGAR at www.sec.gov. Forward-looking statements represent Thera Technologies' expectations as of this morning, February 26, 2025, and investors are encouraged to review the risk factor section contained in the MD&A. Additionally, the company is using the term adjusted EBITDA, which is not a financial measure, under international financial reporting standards or U.S. generally accepted accounting principles. Adjusted EBITDA excludes the effects of items that primarily reflects the impact of long-term investment in 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 issued 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. Hello and good morning to all. Just as we wrapped up our fiscal 2024 year, we shared a slew of material business developments that I will go over in more detail on this call. 2024 represented a real sea change for Athera Technologies. Since embarking on our strategic pivot to fully focus on scaling our commercial business 24 months ago, I'm extremely pleased to have ended the fiscal year with adjusted EBITDA of $20 million compared to minus $3 million a year ago. Our teams delivered exceptionally across all pillars of our business, and I'm proud of what we have achieved this past year. In fact, as you will see, we're only just getting started. Before I jumped into full-year performance, I want to start with some of our recent company developments to set the stage for 2025 and beyond. First, I am pleased to reiterate that we have resumed distribution of EGRIPTA-SVT. The brief shortage of the patient level is now behind us, and patients can once again fill their prescriptions. After many discussions with the FDA on February 13th, the agency via its drug shortage staff indicated that it would allow the company to sell and distribute two newly manufactured batches of Egrifta ASV while the review of the PAS is ongoing. These two batches represent up to six months of supply. We are grateful to the FDA for their continued collaboration and commitment to getting patients their therapy. We have manufactured one additional batches of Egrifta ASV and two additional batches are scheduled for production before the end of the third quarter of 2025. As a reminder, the FAA formulation will be manufactured with a new CDMO based in the US. In early December, we announced that we closed on new credit facilities, securing up to $75 million, which Philippe will expand on later in the call. In addition to replacing our prior credit agreement, this recent financing is truly fit for purpose. This will enable us to execute on our longer-term growth strategy, which is to strengthen and scale our commercial business underpin by our HIV portfolio. This brings me to another major announcement, our partnership with Ionis Pharmaceuticals. We entered into an exclusive licensing agreement with Ionis to bring Donny Dalorsen and Ollie Zarsen to the Canadian market for three distinct indications. Before I go into these exceptional assets and the disease areas they treat, I want to say a few words about our partner. My admiration for Ionis dates back several years to my days at Pfizer where, as the head of the global rare disease business unit, I had the opportunity to familiarize myself with their impressive discovery and development efforts. Ionis is an extraordinary organization and true pioneer in RNA technology. And it is also led by a leadership team that carries the same passion for innovation as we do here at Thera. The first product done in Allorsen is being evaluated for the treatment of hereditary angioedema, or HAE, which is a rare genetic and potentially life-threatening disease that involves recurrent attacks of severe swelling in various parts of the body. HAE. has an estimated prevalence of less than 1,000 patients in Canada. Patients with this condition have treatment options, but they're still on medical needs. Donnie-Dallorsen's efficacy, safety profile, and simplicity of self-administration demonstrate that it offers the many attributes patients are looking for. If approved, Donnie-Dallorsen could be the preferred prophylactic treatment for both patients new to therapy and patients currently on available therapies. Dunny-Dalorsen has been filed in the U.S. with a PDUFA action date of August 21, 2025, and we will also be filing in Canada this year. The second product, Olisarsen, was recently approved by the FDA and is marketed in the U.S. under the name of Tringulza for the treatment of familial chylomicronemia syndrome, or SCS. FCS is a rare genetic disease characterized by extremely elevated triglyceride levels and chronic debilitating symptoms. Those living with FCS have a high risk of potentially fatal acute pancreatitis, which is a painful inflammation of the pancreas, and chronic health issues such as fatigue and severe recurrent abdominal pain. There are less than 300 patients with FCS in Canada, many of them already diagnosed and overly represented in eastern Quebec, where the population is more likely to carry the gene mutation. Currently, there are no approved treatments for FCS in Canada. We will file all these ARCINs for the first indication mid-year in Canada, and we are excited to bring this potential first-in-class innovative treatment to market. In addition, There are three Phase III trials underway evaluating Olisarcin for a much more prevalent disease known as severe hypertriglyceridemia, or SHTG, which is a symptomatic disease where people can suffer debilitating chronic symptoms that impact all aspects of their lives, including severe abdominal pain and cognitive impairment. In the most severe manifestation, SHTG patients can suffer from life-threatening pancreatitis events that require intensive hospital care. As a result, physicians recognize the importance of lowering severely elevated triglycerides with established guidelines already in place. The total addressable market for this second indication represents patients in the millions in the U.S. alone, with a similar prevalence in Canada on a per capita basis. All three studies are fully enrolled with over 2,400 patients with data expected in the second half of this year. We eagerly await the results and enormous potential for this second indication of Olisarcin in Canada. The market opportunity for these products in Canada is significant and is expected to drive growth for years to come over and above our existing business. In Canada, based on recent pricing recommendations specifically for rare disease drugs, we anticipate the commercial opportunity of these assets to exceed $30 million in revenue. However, with the approval of the much larger indication in severe hypertriglyceridemia, we anticipate peak sales of double that amount. As mentioned, we will be submitting regulatory filings for both products to Health Canada in 2025, and preparations for submissions are already well underway. Market readiness, including the identification of specialized centers of excellence and KOL outreach is also moving along rapidly. We are confident in our ability to maximize revenue potential for these opportunities and deliver on additional assets with new and existing partners. As we look ahead, we remain active in building a robust portfolio of high-value innovative assets that can benefit from our established infrastructure and networks in the U.S., but also in Canada. Moving over to our existing portfolio, Agrifta SV realized unprecedented performance this past year. Full-year sales were $60 million, representing 12% growth year-over-year. More importantly, we saw an acceleration in performance in the latter part of 2024. Our field force has been extremely effective in highlighting Agrifta SV's differentiation and unique value proposition. We continue to benefit from a favorable selling environment supported by the continued momentum of GLP-1s. But it's important to understand how our product is different. A grifted ISV reduces excess visceral abdominal fat and actually increases lean muscle mass. While GLP-1s are very effective at lowering body mass index, people with HIV in particular cannot afford to lose muscle mass. Further, excess visceral abdominal fat is increasingly being recognized by treating physicians as a medical condition that requires attention. This supportive landscape has contributed to the strong performance this past year, which will only be further enhanced by the launch of our new F8 formulation with an expected approval on March 25th. This new formulation will be a once-weekly reconstitution as opposed to daily, with 50% reduction in volume of injection leading to a much less cumbersome administration and improved patient experience. Before handing the call over to Philip, I just want to wrap up with a quick update on our oncology program, where we are actively searching for a partner to continue the important evaluation of our novel PDCs. We recently announced preliminary efficacy and safety data from Part 3 of our Phase 1B trial of pseudocetaxel's endosortide. The purpose of this part of the trial was to improve the overall safety profile and improve efficacy for a heavily pretreated population of advanced ovarian cancer patients. Thirteen patients were recruited to two different dosing arms in Part 3. Seven patients received a weekly infusion of 1.75 mg per kg, and six patients received 2.5 mg per kg on a three-weeks-on, one-week-off schedule every 28 days. In the higher dose arm, we observed significant tumor reductions, including one patient with complete resolution of a liver lesion. This efficacy data was further supported by reduction in the CA-125 tumor biomarker in four of six patients. Investigators observed no dose-limiting toxicities in either arm. As a result, I'm very pleased to report that the FDA has agreed to amendments to our protocol to increase the dose of pseudocetaxel xanthosortide on the same weekly infusion cycle to 3.33, followed by 3.90 milligrams per kilogram per week. I want to remind you this oncology program carries a huge amount of favorable preclinical data, which led to the initial FAST-TRACK designation by the FDA. Moreover, we have those 48 patients to date. All in all, we have a meaningful data set for an oncology trial of this kind, and we are confident we can find the right partner to continue this important science. Thanks for now. I will now turn the call over to Philip.