Theratechnologies Inc.

Good morning, ladies and gentlemen, and thank you for standing by. Welcome to TheraTechnology's third quarter fiscal year 2022 earnings call. 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 listening to submit a question may do so by clicking on 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 this time. I would like to remind everyone that this conference call is being recorded today, October 13, 2022, at 8.30 a.m. Eastern Time. I will now turn the call over to Ms. Alif McDonald, Head of Investor Relations. Please go ahead, ma'am.

Thank you, Operator, and good morning, everyone. On the call today will be our President and Chief Executive Officer, Mr. Paul Levesque, and Chief Financial Officer, Mr. Philippe Dubuc. During the Q&A session, we will be joined by Dr. Christian Marcellet, Chief Medical Officer, and Mr. John Leisure, our Global Commercial Officer. Before we begin, I'd like to remind everyone that TheraTechnologies' remarks today contain forward-looking statements regarding its 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 the company will differ materially from those assumptions. As such, the company cannot guarantee that any forward-looking statements will materialize, and you are cautioned not to place undue reliance on them. We refer current and potential investors to the forward-looking information section of our management discussion and analysis. issued this morning and available on CDAR at www.cdar.com and on EDGAR at www.sec.gov. Forward-looking statements represent TheraTechnologies' expectations as of October 13, 2022. With that, it is my pleasure to turn the conference over to TheraTechnologies President and CEO, Paul Levesque. Paul?

Thanks, Salif. Hello, everyone. Thank you for joining us today. Before we start our review of the current reporting period, I'm proud to say that thus far, BISchool 2022 has been an overwhelming success. Quantitatively, our performance to date stands as testimony to the company's hard work in transforming the business for both immediate and future growth. We have witnessed the organization come together as a team over the course of the last year, which is reflected in our numbers. We've put great consideration into our technology's forward operating plan, which has been designed to unlock value in the legacy business. This will be especially impactful now that we have built our own sales teams and have focused activities in the United States. This includes investing in areas such as our medical affairs programs to facilitate the diagnosis of patients with lyco dystrophy and the identification of patients with uncontrolled HIV viral load. We are also enhancing the patient experiences through improved methods of administration and new formulations. In speaking of the patient experience, we wanted to highlight the recent FDA approval of TRIGARZO for administration by 30-second IV push for heavily treated patients. This new method of administration reduces maintenance dose time from 15 minutes to 30 seconds. Not only the safety and PK profile of Trigarzo IV push similar to that of IV infusion, but the new method of administration is designed to make maintenance dosing easier on patients and healthcare providers. Thus, we firmly believe that we will be able to further expand Trigarzo into more clinics and increase patient adherence at the same time. Additionally, the new intramuscular study for Trigarzo is now fully enrolled, and the last patient visit is scheduled for next month. We believe that IAM could provide an even more convenient method of administration, including access to patient treatment outside of the clinic, such as in the pharmacy settings. We are delighted in the fact that we can demonstrate a strong commitment to fostering superior patient experiences. The simple fact of the matter is that the market is ramping up quickly towards non-oral regimens, so the approval of Trogarzo for IV push could not have come at a better time. Incidentally, SART Technologies announced data from two poster presentations at the AIDS 2022 conference showing the potential for improved treatment regimens. The first presentation demonstrated pharmacokinetic modeling data supporting proof of concept that additional methods of administration could be viable. This is a big endorsement for IM formulation administration for which the study will shortly be completed. Furthermore, the second presentations demonstrated how TROGARZO in combination with another fully active agent could lead to simpler dosing regimens in heavily treated experience populations. This abstract was selected as a top 300 abstract by the conference. Moving to IGRIFTA-SV now, which is a current formulation on the market. As previously announced, the FDA requested that the company carry out a human factor study with the ultimate goal of fine-tuning patient instruction for use. The study is ongoing and progressing well, and it is ultimately our hope that this will improve patient adherence to treatment. As the FDA has asked us to do a human factor study for IGRIFTA-SV, we have proactively decided to do one for DFA formulation as well. This study has been initiated and is running in near parallel to the SV study. Given the uncertainty regarding the supply of bacteriostatic water for injection, we have decided to take control of the situation and take matters into our own hands and have signed an agreement with a contract manufacturer to source the water ourselves. We believe this will firm up our timeline to launch the F8 formulation for lipodystrophy and ensure continuous supply of bacteriostatic water upon launch. In settling this go-forward strategy, we're currently on track to deliver the filing of this new F8 formulation in the fourth quarter of 2023 with a targeted launch date in the first quarter of 2024. Now, as a high-level overview of the reporting period, and with one more quarter to go, momentum in our business continues and the sales force that we have put in place is in full swing. As such, we are confident that we will deliver on revenue guidance of between $79 and $82 million while achieving new heights in the new fiscal year. To be more specific on product performance, we're happy to report that year-to-date U.S. revenue growth is a blend at 18% in line with our objectives. TRIGARZO revenues are up 17% year-to-date, while IGRIFTA SV sales are up 18%. This financial performance is being driven by our strategies to facilitate both diagnosis for lipodystrophy patients and patient identification for TRIGARZO. Philippe, as usual, will provide more insights into the reporting periods, consolidated numbers on today's calls, which does include Europe. As noted on the second quarter call, we separately announced the signing of a $100 million non-dilutive credit agreement with Marathon Asset Management, a major institutional healthcare investor. Not only was this a vote of confidence for Thera, the financing also lifts the financial burden of having to repay a convertible debenture due in June 23, which in turn further allows us to execute our commercial and pipeline development plans unencumbered. And while the new growth associated to our commercial activities is very exciting, the future of our technologies remain with the advancement of our powerful sort-one positive oncology platform. As such, we remain laser focused on recruiting patients and advancing the current basket trial. Earlier in the quarter, we provided an update on the dose escalation portion of TH-1902 phase one study and announced signs of efficacy that were observed in three heavily pretreated patients. The preclinical work that we're performing with our sort one positive technology is getting noticed by many in the industry and was featured in the recognized journal The data was published as part of the publication's special issue, Targeting Drug Resistance and Metastatic Pathways for Cancer Therapy. The publication highlighted the in vitro and in vivo efficacy of Th1902 in inhibiting ovarian and triple negative breast cancer stem-like cells. It also served to demonstrate potential mechanisms by which Th1902 can bypass underlying causes of resistance to docetaxel, contributing to treatment failure and disease recurrence. In prior studies, we have shown inhibition of vasculogenic mimicry in vitro, further adding to the body of evidence that SORT1 receptor in our peptide drug conjugate allows for enhanced benefits versus docetaxel alone. This is really the first evidence of Th19O2 targeting of human breast and ovarian cancer stem-like cells, both in vitro and in vivo preclinical models. Our excitement comes from the fact that the potential therapeutic benefits include sustained efficacy, as cancer stem cells can act as hidden cancer cell reservoirs, often associated with recurring cancers. Just yesterday, we announced that we have been selected to present new data showing high expression of SORT1 receptor in several cancer types, The data will be presented in a poster session at the 34th Joint Symposium of ENA, a highly recognized oncology conference that will take place at the end of the month in Barcelona, Spain. We continue to believe that our program's unique mechanism of action gives it an exceptional chance of succeeding where others have not been able to progress. On the TH1902 China Outlicensing and Partnership front, discussions are moving forward as enrollment of the basket trial continues. Finally, as per previous communications, the NASH program remains on pause until we have identified a partner with the capabilities and resources to carry this program forward. By making partnering a condition to advancing the program, we are acting responsibly vis-a-vis our investors as this is a costly endeavor. Recent positive news in the field of NASH has rejuvenated interest from many investors. As one of the only late-phase NASH companies with a mechanism of action that targets the dysregulation of fat accumulation in the ectopic compartments, including the liver, we feel more optimistic than ever in finding a partner and seeing this program move forward. I would like to now pass the call to Philip, our Chief Financial Officer. Thank you, Paul.