Theratechnologies Inc.

Good morning, ladies and gentlemen, and thank you for standing by. Welcome to Thera Technology's third quarter 2024 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 the 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 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, Thursday, October 10, 2024, at 8.30 a.m. Eastern Time. I will now turn the call over to Julia Schneiderman, Senior Director of Communications and Corporate Affairs at Thera Technologies.

Julie, please go ahead. Thank you, Operator, and good morning, everyone. On the call today will be Thera Technologies President and Chief Executive Officer, Mr. Paul Levesque, and Senior Vice President and Chief Financial Officer, Mr. Philippe Dubuc. During the Q&A session, they 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 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 www.sec.gov. Forward-looking statements represent Theratechnology's expectations as of this morning, October 10, 2024. Additionally, today, 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 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, 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 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, Judy. Hello, everyone, and good morning. I'm pleased to be reporting on TheraTechnologies financial results for the third quarter ended August 31, 2024. As I explained during our second quarter call, we have embarked on a new chapter at TheraTechnologies focused on commercializing innovative treatments. This strategic pivot, coupled with a cost structure that is fit for purpose, has enabled the company to achieve profitability and deliver on our commitment to shareholders to be adjusted a bit of positive quarter after quarter. In fact, in a short period of time, the turnaround is nothing short of spectacular. As you have seen today, our third quarter did not disappoint, and we have continued to demonstrate strength on the bottom line with an adjusted EBITDA figure of $7.2 million and a net profit of $3 million. Revenues for the quarter are also trending positively, up 8% from the same period last year and driven by our engine of growth, EGRF-2SV. Enrollments Unique patients and unit souls of Agripta SV reached double-digit growth year-to-date compared to the same period last year. In fact, in the last six months, Agripta SV has recorded, the drug has recorded its best performance in recent history, capturing patients and new prescribers at a non-precedent rate. By highlighting Agripta SV's unique value proposition, we've been able to differentiate the therapy from weight loss drugs where the focus is on BMI. EGRFTA-SV reduces visceral abdominal fat, which, if left untreated, can lead to serious medical conditions and is easily identifiable by measurement of waist circumference. Trigarzo remains one of the few options for the management of HIV multidrug resistance. While it has been facing strong competition over the past year, new prescriptions and repeals of Tricarzo have stabilized, and we do not expect further declines next year. Now, as previously announced in September, our CDMO responsible for the manufacturing of Egrifta SV implemented an unexpected voluntary shutdown following an FDA inspection in order to implement corrective measures to their plant. As a result, the production of two batches of EGRIFT-ASB were canceled, thus creating pressure on current inventory. It is important to note that the corrective measures have nothing to do with the manufacturing process of our medicine, but rather with the environment in which the product is manufactured. I want to be clear that this situation will have no impact at the patient level in 2024. However, We believe it will have an impact on ex-factory sales in the fourth quarter and, in turn, total revenue for full year 2024. Given this, and considering current trends for Trigarzo, we are changing top-line revenue guidance to be between $83 and $85 million. This change does not reflect demand for EGRF-ASV. which in recent history has never been so strong across all metrics, new patients, total unique patients, and unit solds. The new guidance reflects a constrained supply situation. Despite the circumstances affecting our top line, we're happy to firm up guidance for adjusted EBITDA, increasing it to $17 to $19 million from $13 to $15 million. This is a result of adapting our cost structure to our new strategic direction of refocusing efforts on commercial activities. With a cash position of close to $39 million and such a robust trajectory for adjusted EBITDA, we are in a strong position to take things to the next level. Looking to 2025, I want to share the latest information we have on the supply of EGRF-DSV. Our CDMO has reconfirmed it will resume activities mid-October in a manufacturing slot where GRIFTA is rescheduled for the week of October 21st. Thera Technologies will file a Prior Authorization Supplement, or PAS, with the review division. The PAS will include the remediation plan implemented by our CDMO, and we expect to submit in early November. While we expect to have very limited supply of Egrifta ASV in the latter part of November in terms of ex-factory sales, there will be still a six-week inventory held at the wholesaler and specialty pharmacy level. This will be enough drug to meet patient demand until mid-January. ESD has up to 120 days to approve the PAS and enable the batch to be released. As such, we took the precautionary step to notify the FDA drug shortage staff of the situation and also advise the market. We are working closely with all stakeholders and remain confident that any impact on patients in 2025 will be avoided. Moreover, we believe that in the first part of 2025, we will fully make up for sales not recorded in the fourth quarter of 2024. We will continue to update the market as things become available. Turning to the DFA formulation of Tessam Orlin, I want to provide an update on our timelines for a resubmission to the FDA. Following our Type A meeting with the FDA, we believe we have addressed all of the agency's questions, including the ones related to immunogenicity and microbiology, and I'm confident these pieces are behind us. We expect to have the file completed shortly and intend to submit by the end of November. The FDA has confirmed a four-month review. It is also important to note that our CDMO for DF8 is not the same as our manufacturer for DF4. Our team believes strongly in the benefits of Tessam Orlin as the only FDA-approved treatment of its kind for people with HIV and lipodystrophy, and we are all hands on deck to bring this new formulation to market and to continue sharing our value proposition in new data. Next week, three Theratechnologies posters will be presented at ID Week in Los Angeles. ID Week is one of the foremost scientific conferences in this field. One poster presents data linking excess visceral abdominal fat, or EVAF, to increased cardiovascular risk in people with HIV, while a second poster documents how use of Tessamorlin to reduce excess visceral abdominal fat can lower cardiovascular disease risk in people with HIV. And other posters will report on the study design and baseline characteristics of the PROMIS-US trial, an observational real-world study of ibelizumab in heavily treatment-experienced patients with multidrug resistance. We've also had the recent publications on ibelizumab data in the Journal of AIDS. As people live longer with HIV and with greater exposure to antiretroviral medicines, they may experience higher amounts of excess visceral abdominal fat and risk multidrug resistance. We look forward to sharing our findings with HIV clinicians and researchers and to contributing to the scientific and treatment discourse on HIV. In keeping with our commitment to adding value through medical activities, I would like to provide an update on our ongoing Phase I clinical trial of Pseudocetaxel's endosortide, our lead investigational PDC candidate. At this time, recruitment for both cohorts in advanced ovarian cancer has been completed. We've had no reports of DLTs, including neuropathy and itoxicity. One patient remains in the trial at the higher dose of 2.5 mg per kg, and we plan to share results once the last patient has completed treatment and the overall data analysis is finalized. Our strengthened financial positioning, in particular our bottom line performance and cash position, has changed many things for us, opening the door to new possibilities and collaborations. We have doubled down on our efforts to find new products to market and to enter into partnerships. To this end, we've made significant progress in our search for new products both in the U.S. and in Canada. Based on our experience with the grifta and drogarzo, as well as the commercial capabilities we have built, we are uniquely positioned to in-license and bring to market innovative therapies that challenge the standard of care in rare or niche markets. This requires a specialized set of skills and experience managing regulatory and market access requirements and specialized patient support initiatives. We are confident that Thera Technologies has a compelling value proposition to offer. Our North American focus strategy is very clear, and we are confident we can achieve our long-term objective of delivering sustained top and bottom line growth and value for shareholders. With this, I'd like to turn the call over to Philippe, who will go over the periods, financials, and details. Philippe? Thank you, Paul.