Theratechnologies Inc.

Good morning and welcome to the Thera Technologies second quarter fiscal year 2022 earnings call. All participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then one on your telephone keypad. To withdraw your question, please press star then two. Please note this event is being recorded. I would now like to turn the conference over to Elise McDonald, Senior Director of Investor Relations. Please go ahead.

Thank you, Andrea. Good morning, everyone. My name is Elise McDonald, and I recently joined Thera Technologies to lead the Investor Relations Program. I'm thrilled to be here and look forward to working closely with the amazing team at Thera Technologies, our investors, analysts, and capital market partners. I am especially excited about working with our outstanding management team and our exceptional board of directors. On the call today, you will be hearing from our president and chief executive officer, Mr. Paul Levesque, and senior vice president and chief financial officer, Mr. Philippe Dubuc. In addition, we will be joined by Dr. Christiane Marcellet, senior vice president and chief medical officer, and Mr. John Leisure, our global commercial officer, for our Q&A session. 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, results, levels of activity, performance, goals or achievements, or other future events or developments. In preparing these forward-looking statements, several assumptions were made by Thera Technologies and there are risks that results obtained by the company will 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. Thera Technologies refers current and potential investors to the forward-looking information section of its management's discussion and analysis filing issued this morning and available on CDAR at www.cdar.com and on EDGAR at sec.gov. Forward-looking statements represent TheraTechnologies' expectations as of July 13, 2022. Except as may be required by securities laws, TheraTechnologies does not undertake any obligation to update any forward-looking statement whether as a result of new information, future events, or otherwise. With that, I would now like to turn the conference over to TheraTechnologies President and CEO, Mr. Paul Levesque.

Thanks, Elif, and welcome to our team. Hello, everyone. I hope that everyone has had a good start to their summer. And thank you so much for joining the TheraTechnologies team for our update call today. As we enter the second half of the fiscal year, we are making progress in real time across all of our strategic imperatives. What I mean by this, and as you've seen from our latest press releases, is that we've been very focused on our efforts to move the corporate needle forward and hit critical milestones for our commercial business and therapeutic pipeline. We are executing despite challenging times, not only in the biocapital markets, but also the tough overall macro environments which have been affected by inflation, supply chain issue, and geopolitical turmoil that we are witnessing on a daily basis. This is why the updates that we have provided this quarter, and there have been many as of recent, are helping to distinguish Thera Technologies from other healthcare names. Operationally, not only are we surviving through these tough moments, we are thriving. We announced yesterday that we successfully received a binding commitment letter for a $100 million non-dilutive term loan with Marathon Asset Management. The credit facility significantly strengthens our balance sheet and will make it possible to rapidly buy back and cancel $30 million of convertible notes due June 2023 through private agreements with certain U.S. note holders. The financing stands as a testament to our unique investment proposition and a real vote of confidence from a world-class asset management firm that is well known for its excellence in producing risk-adjusted returns on behalf of their investor base. Marathon's investment in Thera is indeed a show of support, not only for our mission, our track record of execution, but also for the whole management team. This morning, we announced an update on our TH-1902 program, which highlighted our lead asset safety profile and tolerability. As Christian can further explain, the pharmacokinetics data observed in humans showed low levels of free-dose Hidnaxel, consistent with what was observed in the prior preclinical studies, leading to a better safety profile than the use of cytotoxic alone. As noted in the release, we established a safety profile at 300 mg per square meter, or 1.5 times the therapeutic dose of docetaxel alone. Notably, one patient with endometrial cancer achieved stable disease over a 33-week period and was able to receive 11 cycles of TH1902. This is a clinically meaningful result in late-stage disease, where they are very limited treatment options. We also had two advanced prostate cancer patients who had progressed on standard chemo or hormone therapy. Both showed signs of efficacy. The first patient achieved a confirmed partial response with a tumor mass reduction of 53%, and the other patient achieved a PSA response with stabilization of disease without any further progression. Given that, on average, patients received eight rounds of treatment prior to TH1902. We are very encouraged by this update. It is meaningful and gives us hope that we can help improve patient outcomes and change the lives of those touched by heart and very hard to treat cancers. Building on our oncology pipeline update, we are so pleased to note that the CQDM, Quebec Biopharmaceutical Research Consortium, has provided a new cancer research grant to validate the entire metastatic potential of Th1902. The CQDM, together with the Quebec Breast Cancer Foundation and Mitacs, announced a contribution of more than one million Canadian dollars for a new research project at Université du Québec à Montréal focused on several metastatic cancer models. In particular, this new investment will further expand our knowledge in advanced metastatic breast cancer. This public-private partnership complements Athera Technologies' annual investment in the development of our targeted oncology platform using Th1902 in breast cancer and could increase the spectrum of patients or cancer patients who might ultimately benefit from this new therapy. Now, let's look at this past quarter's event. As noted in today's earnings press release, we have executed on our strategic plans in the quarter including our decision to focus sales efforts on the U.S., which is our strongest core market. As announced in April 2022, we made the decision to return commercialization rights of Tragarzo in Europe to our business partner, TimeEd Biologics, who owns the molecule. A notice of termination has been sent to TimeEd, and the transition will be complete by the end of October 2022. Despite this decision, TAIMED remains a very strong strategic partner for us. While we had every intention of bringing TruGarzo to Europe patients, it became clear through pricing and reimbursement discussion with local governments that we would not be able to carry a viable and sustainable business in the region. We recognize the uncertainty this situation may have caused for key stakeholders, especially patients, and we remain absolutely committed to a smooth transition back to TimeEd, and will continue to provide all necessary support for them to make important decisions concerning European patients' access to Trogarzo, a treatment whose therapeutic benefits have been proven. The shift in focus to the U.S. and the time to make the appropriate operational transition narrows our revenue range to roughly the midpoint of our forecasted 2022 guidance, as we expect our top-line revenue to be within $79.82 million for the full 2022 fiscal year. Commercially, we remain on track with our financial goals as consolidated sales grew 8.3% to $19.3 million for the quarter. Reflective of the momentum built up in our sales strategy, year-to-date revenue grew 13.9% to $37.8 million, which puts us well within striking distance to meet or better exceed our target as fiscal year guidance. In looking at Q2 versus Q1 patient enrollment numbers for the year, Egrifta's enrollment grew by 48% and Trigarzo by 26%. Combined quarterly patient enrollment growth was 19% year over year We believe these meaningful increase was driven by the return of in-person patient visits in doctor's offices following the easing of pandemic restrictions. Supporting these solid top line numbers has been the onboarding of our dedicated commercial field force in the US, which is now complete. Moreover, we have made key additions across the company in line with our corporate strategy, and to support our ongoing and expanded projects. We are pleased to welcome new team members to Athera Technologies and look forward to their contributions and leadership in their respective roles. I think we have some of the brightest and best talent in the industry and the business, and I appreciate their hard work and dedication to the mission and purpose of our company. Exiting the first half of 2022, we continue to be pleased with the recapitalization of the company as it allows us to continue to grow our commercial business to scale. Furthermore, we believe this supports our future revenue growth, which we are driving through evaluating and extending the lifecycle management of our existing commercial products, while successfully moving our lead oncology asset through its larger basket trial. Additionally, outlicensing, development, and commercialization rights for TH1902 in Greater China continue to move forward. We are very excited to showcase our dose escalation data to further these discussions and continue to move forward with an increasing number of potential partners. Now, let me update the market with regards to lifecycle management of our commercial business at a high level. In March 2021, we submitted an amendment to the FDA to the instructions for use section that is included in the IGRIFTA-SV patient information. This followed some complaints the company received from patients related to the reconstitution of IGRIFTA-SV after its launch in 2019. Along with these new instructions, we now provide patients with detailed training through our call center, and the number of complaints have dropped dramatically. The FDA responded to our amendment outside of the timeline set forth in the regulation with a complete response letter asking the company to carry out a human factor study to ensure that patients reconstitute the product in the proper manner. We have recently initiated the study, which we believe will be carried out to the FDA's satisfaction and also within their imposed timeframe of one year. This request does not affect the commercial availability of a GRIPTA SV. As previously announced, our intention was to file an SBLA for the FH formulation by the end of the first quarter of calendar 2022. Unfortunately, the issue around the global supply of bacteriostatic water for injection required for the reconstitution of the FH formulation has not been resolved. According to the FDA website, the estimated recovery of supply of bacteriostatic water is scheduled for October 2022. In addition, since the FDA has asked us to perform a human factor study for the reconstitution of Egrifta SV, we have proactively decided to carry out this study before filing the SVLA for the F8 formulation. As such, We will be filing the SBLA for the F8 once we have consistent sourcing of bacteriostatic water for injection and have completed the human factor study. Now, I'd like to provide an update on NASH. The NASH program is still on pause pending the sourcing of bacteriostatic water and the securing of a partner with resources and capabilities. After internal discussions and to further de-risk the Phase III trials, The company has submitted an amended protocol to the FDA. The new protocol, Phase 2B-3 Seamless Study Design, includes an interim analysis of the first 350 or so patients. This data will be analyzed by a data monitoring committee to assess the efficacy of the Samorlan and will allow us to generate hard endpoint data on NAS score and fibrosis. A decision will then be made whether to continue the study until the full number of patients, 1,094, have completed 18 months of treatment. The FDA has agreed to this redesign protocol. We continue to have discussion with potential NASH partners and are very encouraged to see renewed NASH interests and recent industry partnership announcements. Finally, on Tragarzo, an FDLA was filed with the FDA in the fourth quarter of 2021 for the company's IV push mode of administration for the treatment of HIV patients. The FDA has accepted our filing and has provided a target date of October 3rd, 2022 in accordance with the Prescription Drug User Fee Act. Theratechnologies and Tymid are also evaluating an intramuscular mode of administration for Trigarzo within the TMB-302 study. This trial is now fully enrolled, and we expect completion of the study in the second half of 2022. That covers our updates for the quarter, and I would like now to pass the call to Philippe, our CFO. Philippe?