Theratechnologies Inc.

Good morning, ladies and gentlemen, and thank you for standing by. Welcome to TheraTechnologies' fourth quarter and full year fiscal 2023 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, February 21, 2024, at 830 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 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 cedarplus.ca and on EDGAR at sec.gov. Forward-looking statements represent Thera Technologies' expectations As of this morning, February 21st, 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. Theratechnologies 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, available on CEDAR 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 Theratechnology's investor website at theratech.com. With that, I would now like to turn the conference over to our President and CEO, Paul Levesque.

Thank you, Julie. Hello, everyone, and good morning. I am pleased to be reporting on Thorough Technology's financial results for the fourth quarter and full year ended November 30th, 2023. What began as a challenging year for the company shifted in the second half to end 2023 on a high note with record quarterly sales, a dramatic turnaround in adjusted EBITDA, and a financing that strengthen our balance sheet with new high quality institutional investors. Our strategy of pivoting our primary focus to commercial operations and minimizing resources for research and development activities is already paying off. We ended the year with strong fourth quarter results and are well on our way to achieving a solid adjusted EBITDA number in 2024. Q4 2023 was the highest quarterly revenue we've ever recorded in the company's history. Third quarter momentum in new prescription growth continued through the fourth quarter, translating into $23.5 million in sales, ending 2023 with total annual revenue of $81.8 million. This is a significant accomplishment in light of the hurdles we faced in the first half of 2023, namely inventory drawdowns, and non-favorable gross-to-net challenges. We also demonstrated strength on the bottom line in Q4 with a positive adjusted EBITDA of $5 million. This was our second consecutive quarter delivering on the strategic imperative, more than doubling adjusted EBITDA from Q3 to Q4 and ending the year with an adjusted EBITDA loss of only $2.9 million. This is a dramatic turnaround in cooperation to year-end 2022 when we reported an adjusted EBITDA loss of $22 million. Based on the strength of our performance over the last six months, we are providing guidance today of revenues between 87 and 90 million, with an adjusted EBITDA in the range of 13 to 15 million for the full year 2024. By doubling down on our commercial capabilities, we are more determined than ever before to create value for our shareholders in 2024. With the year already well underway, we are seeing a solid trend on key performance metrics such as enrollments and unique patients, signaling that our objectives can be achieved and even surpassed. However, based on the buildup and subsequent drawdown of inventories in the early part of fiscal year 2023, investors should expect some variability in revenue growth reporting in 2024, especially in the first half of the year. This being said, we are confident in delivering growth over full year 24, as evidenced by today's revenue and adjusted EBITDA guidance announcement. Now that this stage is set for our growth trajectory, let's dive deeper into what's driving our top line. Agrifta SV continues to be the standout product in our portfolio. Over the past six and eight months, Our team has demonstrated capacity to capture new patients in the ever-evolving competitive environment. In fact, our total number of unique patients hit an all-time high at the end of calendar 2023, up 13% year-over-year for the month of December. Allow me for a moment now to remind people about the Greta's SV's benefits and marketing benefits. given the noise about weight loss drugs, and particularly GLP-1s, where recent clinical research has shown them to also induce muscle mass reduction. As the only medication of its kind approved in the U.S. and designed specifically for adults with HIV, Agrifta-SV's unique mechanism of action decreases excess visceral abdominal fat while actually increasing lean body mass. This is especially important for people with HIV where muscle loss can be a serious issue. Furthermore, healthcare providers are increasingly recognizing that excess visceral abdominal fat is a medical condition that can lead to very serious health consequences if left untreated. We welcome this shift in understanding and diagnosis that should support patient identification and market demand for a GRIF-ISV. Before we move on, I want to address the recent update concerning our SVLA for the FAA formulation of Tesamorlin and take a moment to review the facts and timelines. As you are aware, on January 22nd, we were notified by the FDA that they would not meet the PDUFA date. At the time, we had received very few questions and had responded swiftly to all FDA requests. On January 23rd, at the end of the day, we received a complete response letter. While we are disappointed by this turn of events, we are confident in the FH formulation and plan to address the agency's comments in due course. To this end, we have been working closely with external regulatory experts to develop the comprehensive plan of action. In addition, we have requested a Type A meeting with the FDA to ensure our approach is aligned with their expectations. Let's take a closer look at the details. As previously explained in the press release, the questions outlined in the CRL are largely related to chemistry, manufacturing, and controls, also known as CMC. Concerning the microbiology, assays, impurities, and stability for both the drug product and the final reconstituted product. We already have most of the information on hand to address these questions, and we have started work streams related to the assay and microbiology. In addition, the FDA requested further information to address the potential impact of the new formulation on the immunogenicity risk. On this, after consultation with experts, we are preparing a risk assessment in accordance with the FDA's guidelines and we do not believe that additional clinical studies are required. Given the progress we have made since January 23rd, we remain focused on resubmitting our file to the FDA and obtaining approval of the FH formulation before the end of 2024. Our upcoming interaction with the FDA will further inform and confirm our resubmission plan and timelines for launching. In the meantime, I want to emphasize that this delay in no way impacts our successful commercialization of IGRIFTA-SV, which, as I mentioned earlier, generated record sales in 2023. Let's now shift gears and look at TruGarzo. In spite of the new market entrance, TruGarzo continues to be a vital treatment for people with HIV who have few options, and it remains a good companion to IGRIFTA-SV. In order to maximize our reach and impact, we have begun to tailor promotional efforts and hone in on healthcare providers who are specifically addressing multidrug resistance. We are determined to increase the value for the HIV community while also enabling Trogazo to be more profitable. These efforts to maximize Trogazo's benefits and wind down our R&D efforts for the lifecycle management of our products were further complemented by a series of regulatory milestones in December, beginning with the FDA approval of the IV push loading dose of Trabarzo. This simplified method of administration takes only 90 seconds and means that new patients no longer require initiation of treatment by 30-minute infusion. Using the IV push method for both loading and maintenance doses, makes Trogarzo a much more convenient option for heavily treated experienced adults and their healthcare providers. Moreover, we are awaiting the PDUFA date for the SBLI submission of an intramuscular administration of the Trogarzo maintenance dose. These line extension efforts exemplify our commitment to innovate, further improve adherence, and simplify the treatment experience for people with HIV. Now that we have completed most of the significant parts of these important projects, we have reset our cost base to better align with our overarching commitment to profitability. We are steadfast in realizing our strategic goal to reach more patients with new and improved products through organic but also inorganic opportunities. As stated previously, our U.S. commercial capabilities are primed to scale up for bolt-on accretive products and new partnerships. In this regard, we remain committed to our investors and will leave no stone unturned as we looked at all opportunities. Our efforts to be stringent with operating expenses while focusing on top-line growth through organic and inorganic opportunities have not gone unnoticed in the marketplace. In particular, I want to highlight our recent financing, which brought in new investors, among them Evistisma Quebec. Evistisma Quebec is a local fund that identified Thera Technologies as a company that can play a leadership role in Quebec and the broader Canadian biopharma ecosystem. IQ has chosen to invest in us because they believe in our capabilities. They came in to facilitate the growth strategy and ultimately participate in the creation of shareholder value. We welcome them to Thorough Technologies, thank them for their support on the business, and look forward to their strategic contributions. In addition to revenue expansion opportunities through our current commercial business and the growth potential that exists via acquisitions and partnerships, We are encouraged by the continued interest in our oncology program. We recently announced that we have enrolled the first six patients in part three of the phase one clinical trial of our lead investigational anti-cancer agent, Pseudocetaxel's endosortide. With these milestones behind us, we're well on our way to generating new evidence for this asset in the treatment of advanced ovarian cancer. We look forward to enrolling the next six patients at a higher dose and two reporting results in 2024. With the stunning investment made by industry in antibody drug conjugates in the past year, we remain confident that our peptide drug conjugate platform will attract the attention of oncology players in the near future. As a reminder, we have more than 40 patients who have been dosed with pseudocetaxelzendosortide building safety and efficacy evidence and confirming the role of the sortiline receptor. We are also encouraged by the results shared in the recent publications in Frontiers in Immunology, showing significant infiltration of tumor lymphocytes following the treatment of pseudocetaxel's endosortide in a cold animal model. In addition, on the preclinical front, we are advancing new peptide drug conjugates with other potent payloads. Therefore, while pseudocetaxel xanthosortide has already demonstrated in human activity, one has to remember that our SORT1 technology platform provides immense possibilities to advance other PDCs. Our early data suggests that these PDCs could be used alone or in combination with targeted therapies including checkpoint inhibitors. And finally, we believe our peptide could be conjugated with other anti-cancer treatment modalities, such as radioisotopes and nanoparticles. Before concluding, let me highlight our objectives for 2024. With growth and profitability as cornerstone of our operating plan, we have set ourselves up for a promising year with four clear and focused strategic imperatives. First, we are focused on growing the top line in delivering an adjusted EBITDA in the range of 13 to 15 million. This, even considering a final $5 million investment in oncology. We will accelerate the profitability of the company by leveraging our commercial capabilities and acquiring immediately a creative products that are aligned to our expertise. Therefore, M&A activities will be a key priority in 2024. We will seek to derive value from our investment in oncology with our Phase I clinical trial, and we'll continue to search for partners for pseudocetaxel's endosortide in our entire oncology platform. And finally, we all know that the plan is only as good as the people executing on it. To that end, we will continue to enhance and engage our talented team towards a new journey focused on commercialization. With this, I'd like to turn the call over to Philippe, who will go over the periods, financials, and details.