Theratechnologies Inc.

Good morning, ladies and gentlemen, and thank you for standing by. Welcome to Thera Technologies' first quarter 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 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 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 10, 2024, at 8.30 a.m. Eastern Time. I will now turn the call over to Julie Schneiderman, Senior Director, Communications and Corporate Affairs at Thera Technologies. Julie, please go ahead.

Thank you, Operator, and good morning, everyone. On the call today will be Theratechnologies President and Chief Executive Officer, Mr. Paul Levesque, and Senior Vice President and Chief Financial Officer, Mr. Philippe Dubuc. During the Q&A session, we will be joined by Dr. Christian Marsolais, Senior Vice President and Chief Medical Officer, and Mr. John Leisure, the company's Global Commercial Officer. Before we begin, I'd like to remind everyone that remarks today contain forward-looking statements regarding the company's current and future plans, expectations, and intentions with respect to future events. Forward-looking statements are based on assumptions, and there are risks there are risks that results obtained by Thera Technologies may differ materially from those statements. As such, the company cannot guarantee that any forward-looking statement will materialize, and you are cautioned not to place undue reliance on them. The company refers current and potential investors to the forward-looking information section of Thera Technologies' management discussion and analysis issued this morning and available on CEDAR Plus at www.cedarplus.ca and on edgar at www.sec.gov. Forward-looking statements represent Theratechnology's expectations as of this morning, April 10, 2024. Additionally, today, the company is using the term adjusted EBITDA, which is not a financial measure under International Financial Reporting Standards, IFRS. or U.S. generally accepted accounting principles, U.S. GAAP. Adjusted 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 issued this morning and available on CEDAR Plus and on EDGAR at the web addresses mentioned earlier. Investors can also follow the company on LinkedIn and X, formerly Twitter, and sign up for alerts on Theratechnologies' investor website at at theratech.com. With that, I would now like to turn the conference over to our President and CEO, Paul Levesque.

Thank you, Judy. Hello, everyone, and good morning. I am pleased to be reporting on TheraTechnologies' financial results for the first quarter ended February 29, 2024. Today, I will be brief, as we were together not that long ago for our fourth quarter and full year 2023 call. You may recall that we ended 2023 with a very strong second half. This rounded out a six-month positive trajectory with Agripta SV as our engine of growth and a robust adjusted EBITDA number to set us on a path to profitability in 2024. I also alluded to the fact that we should expect some variability in revenue growth reporting in 2024, especially in the first half of the year, based on the buildup and subsequent drawdown of inventory. For Q1, to little surprise, this has been the case. Our first quarter 2024 sales results are a stark contrast to those reported in the first quarter of last year, which I will elaborate on shortly. Looking forward, a reverse trend is unfolding. In fact, we expect a stronger second quarter for 2024 versus the unusually weak second quarter reported in 2023. We also expect second half reporting to better reflect our overall performance. While sales reporting has been erratic, enrollments and unique patients show consistent growth, particularly when it comes to our priority brand, Agripta SV. First quarter momentum in new prescription growth continued, with new enrollments up 21%, and the number of unique patients up 14% compared to the first quarter of 2023. Interestingly, the number of unique prescribers is also steadily increasing, up 13% this past February alone as compared to the same month in 2023. We've also continued to demonstrate strength on the bottom line, making this our third consecutive quarter of near flat to positive adjusted EBITDA. Our new cost structure, together with our strategic focus on commercial capabilities, puts Athera Technologies on the brink of producing stronger cash flow and value for shareholders. As such, I'm pleased to reaffirm our guidance for full year 2024 of revenues between $87 and $90 million, and it just stood a bit down in the range of $13 to $15 million. Let's take a moment now to circle back on the inventory challenges we have faced so that I can provide clarity on the disconnect we are seeing between our key performance indicators and top-line results. To illustrate the situation, I want to highlight how sales of Agripta SV to a few specialty pharmacies has been out of sync with demand, resulting in a historically low number of days on hand. When we take a closer look at the slide, you can see that inventory on hand at the end of first Q23 was approximately 55 days. In contrast, the inventory on hand at the end of first quarter 24 was only about 27 days. The difference in days on hand has impacted our first quarter revenues and growth. We are actively monitoring our distribution network with the goal of maintaining 30 to 35 days on hand at the pharmacy level. At the same time, I want to reiterate that patient demand remains strong, with total patient numbers up significantly from the same quarter last year. Together, these factors should lead to more stable revenue growth. Now, before we move on to oncology, allow me to provide an update concerning recent FDA submissions and how we are moving forward the lifecycle management of our products with the F8 formulation of Tesamorelin. During our last earnings calls, I shared an overview of the complete response letter we received from the FDA in January and our plan of action for a type B meeting with the FDA. The meeting took place several weeks ago. And we received important feedback on our file. We are now awaiting the FDA's minutes of the meeting and remain on track with our resubmission and to receive an FDA decision before the end of 2024. Finally, I want to touch on the intramuscular administration of the Trogarzo maintenance dose. The refusal to file letter received from the FDA in February indicates that it would require the conduct of a new study to pursue the registration of the IM method of administration. Given the cost of the study and the evolving competitive landscape, we have decided to deprioritize this project for the foreseeable future. It is important to know that the IV push method of administration for Trigarzo is already simplified or simplifying the treatment burden for patients and their healthcare providers as a quicker and more convenient option. Trigarzo remains a vital therapy for a small subset of people with HIV who have very limited treatment options at their disposal to address multi-drug resistance. Equally, it is an important companion to a Grifta SV. Now on to oncology and the acceleration of our Phase I clinical trial on pseudocetaxel's endosortide. The recent announcement that the enrollment of the new cohort of patients at the increased dose level is underway is an important milestone. The first patient has already been treated with the 2.5 mg per kg dose, the equivalent of 1.5 times the dose of docetaxel when used alone, sets us well on our way to further characterizing pseudocetaxel xanthosortide as a potentially viable therapy for individuals with advanced ovarian cancer. Earlier this week, our team presented two preclinical posters at ACR in San Diego. I want to highlight the results of our new chemtothesin peptide conjugates in the treatment of sirtulin-positive colorectal cancer, and in particular, the PDC with an exaticant payload. We have also completed the preliminary characterization of several additional novel PDCs. In addition to the human data we have on pseudocetaxel's endosortide, these latest preclinical data highlight the promising tolerability in anti-tumor effects of our new PDCs, further demonstrating the versatility flexibility, and effectiveness of our SORT1 positive technology platform. Now that we have significantly advanced our oncology program with important evidence on multiple PVCs with different payloads, coupled with the more than 40 patients already treated with pseudocytac cells and Dusortide, we believe we are in a position of strength to continue engaging with a partner for additional developmental steps. We are now accelerating these activities. Turning to commercial business development, as we move further along our journey as a bottom line focused biopharma company, I know there is a great deal of anticipation for further details around product acquisitions and future growth. I want to reiterate that our growth trajectory for both the top and bottom line has put us in a position of strength. This should facilitate the acquisition of new assets, which could be instruments of value creation for shareholders. With M&A more important than ever for third technologies, the timing is ideal to welcome two new board members, Jordan Zwick and Elina Qi, both with an abundance of expertise and experience in this area. With this, I'd like to turn the call over to Philippe, who will go over the periods, financials, and details. Philippe?