We'll begin again. 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 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 any time. I would like to remind everyone that this conference call is being recorded today, February 28th, 2023 at 8:30 A.M. Eastern Time. I will now turn the call over to Ms. Elif McDonald, head of investor relations. Ms. McDonald, please go ahead. Thank you, MJ. Good morning, everyone. On the call today will be our President and Chief Executive Officer, Mr. Paul Lévesque, and Chief Financial Officer, Mr. Philippe Dubuc. During our Q&A session, we will be joined by Dr. Christian Marsolais, Chief Medical Officer, and Mr. John Leasure, our Global Commercial Officer. Before we begin, I'd like to remind everyone that Theratechnologies remarks today contain certain forward-looking statements containing 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 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. We refer current and potential investors to the forward-looking information and risk factors section of our management's discussion and analysis issued this morning and available on SEDAR at www.sedar.com and on EDGAR at sec.gov. Forward-looking statements represent Theratechnologies expectations as of February 27, 2023. With that, it is my pleasure now to turn the call over to Theratechnologies President and CEO, Paul Lévesque. Paul, go ahead. Thank you, Elif. Good morning, everyone. Today, we will be providing a review of our fourth quarter and full year 2022 financial results, business developments, and discuss what lies ahead for Theratechnologies in 2023. We have a lot to go over. Let's get started. First, I want to review some of our accomplishments and the milestones we have reached in the fourth quarter, bringing a strong finish to the year. 2022 wasn't just a successful year for Theratechnologies, but also one of big transformation. While Philippe will be providing a deep dive into the financials later on, I can tell you that our fourth quarter consolidated revenues ended at $21.4 million, reflecting a 14.2% growth. Annual revenues reached $80.1 million or approximately 15% growth in line with our 2022 revenue guidance. We are very pleased with these numbers because they reveal to us that the decisions we made during the year, such as bringing the sales teams in-house under strong commercial leadership and withdrawing from Europe in order to focus on the United States, have made a difference. In fact, these are the very reasons or results that give us the confidence to expect revenues for full year 2023 to come in between $90 million and $95 million. With such revenues and tight expense management, we are confident we will achieve positive adjusted EBITDA by year-end. Over the fourth quarter of 2022, our capital markets outreach was stronger than ever, and I was delighted to be on the road and meeting investors face to face for the first time in a long time. We appreciated the support of our capital market partners. We are pleased to welcome two new teams to our coverage. We look forward to working closely with Louise Chen of Cantor Fitzgerald and Justin Walsh of Jones Trading, and welcome them. We have also been very pleased with our relationship with Marathon Asset Management. We were very fortunate to secure a strong and strategic partner in a market that was very difficult for our sector in 2022. We were able to strengthen our financial position subsequent to Marathon credit facility in July by utilizing the first tranche towards purchasing $30 million of convertible notes due in June 2023. We look forward to a long and progressive relationship with them in the years to come. Let's take a moment now to touch on the greater macro environment. For biotechs, the last 18 months have been one of the most difficult periods the industry has ever seen. On average, the sector lost 40% of market value, and we were not spared. I want to acknowledge Theratechnologies' stock price, which currently trades around $1. I would be remiss if I did not admit our surprise at the market's reaction to the enrollment pause for the TH1902 phase 1 clinical trials back in December. We know that in the days and weeks that followed our announcement to voluntary pause enrollment, only about 3.5 million shares traded hands, and yet those shares cut our market cap by half. While we have no control over market activity, we were disappointed with the impact it had on our market cap. We are encouraged, however, that our largest shareholders and nearly 93 million shares held strong. In fact, based on recent filings, our top shareholders have added to their positions. I want to thank all of our shareholders, big and small, for their continued support in these uncertain times. The flip side, the takeaway from the investor reaction reveals to us that there is significant value assigned to the oncology program. Let me be clear. We believe today, as we did on December first, that the decision to pause enrollment was the right one for our clinical trial, our patients, our company and our shareholders. It was not an easy decision, but the right one. This decision was also supported by the FDA in our subsequent conversation with them. We strongly believe that by triggering some changes to the protocol, we will increase our probability of success. Our plan for TH1902 is to present an amended protocol to the FDA and resume dosing patients thereafter. Once the Phase 1 clinical trial has resumed, the company will also evaluate potential partnerships for TH1902. As outlined in my letter to shareholders in January and on many discussions with investors, we plan to fully lean into the growing commercial business. We have built a strong team under the leadership of industry veteran John Leasure, and our team has demonstrated their ability to drive business growth, and our infrastructure allows us to take on more to accelerate the growth trajectory. Let me take a minute now to go over the success we've had with our two brands. They have both clearly returned to solid double-digit sales growth in 2022. A 17.3% increase for EGRIFTA and 10.4% increase for Trogarzo. Our lead product, EGRIFTA SV, has had the best annual volume growth rate since 2017. In addition, when looking at the pool of patients that started therapy in 2019, 40% of Trogarzo and 33% of EGRIFTA SV patients are still on therapy after 24 months. Increasing long-term compliance was a key success factor for us in 2022, and it looks like we have moved the dial in the right direction. When it comes to Trogarzo, early analysis seems to demonstrate that the method of administration available as an IV push now has been well received and has opened new possibilities for the brand. Tactically, we are leveraging our new sales and medical team to expand awareness and utilization of EGRIFTA and TROGARZO with specialty prescribers and people living with HIV across the continuum of care. We have identified the three strategic pillars or imperatives for growing the business. First, we must deliver on science, which means we need to establish scientific rationale for treating adults with HIV and lipodystrophy. Similarly, doctors need to address uncontrolled viral load to make patients undetectable. We are leveraging all scientific publications through medical science liaison to educate HIV providers with the latest evidence. The second pillar is simply to pull the patient in. Helping them understand what excess visceral fat and uncontrolled viral loads are, what it means for them, and what they can do about it. Finally, we have hired nurse educators on the ground who are helping patients with their administration and improving their experience for superior compliance. Although we have a solid plan for building a profitable business with our current assets, we are also looking for opportunities to accelerate our journey. We believe there are accretive opportunities from products that may no longer fit the portfolio of larger firms, but would be a great complement to our products, such as those that are in HIV or HIV adjacent, allowing us to leverage our capabilities. Such opportunities could translate to in-licensing deals, co-promotions, or even a small acquisition. In the spirit of leaving no stone unturned, we have entered into an agreement with the World Orphan Drugs Alliance, WODA, for the distribution of EGRIFTA SV into 41 countries through named patient programs. This experiment may bring EGRIFTA SV to a number of new patients outside of the United States and may lead to additional revenues. While we are working towards achieving profitability, defined as positive adjusted EBITDA, I can tell you that we have turned to tightening our spending. Moving forward, we will be driving leverage P&L. This means a pivot to more stringent monitoring of expenses during the course of normal business. We have many one-off R&D expenses that will phase out as a function of time, such as the human factor study and the development costs associated to Bacteriostatic Water for Injection. Talking about the human factor study, we are on track to complete the study for EGRIFTA SV in the first half of 2023. We're also confident in successfully addressing the shortage of Bacteriostatic Water for Injection. We have now identified a third-party supplier for manufacturing the water and have already manufactured the validation batches. We are still on track to complete the work associated with the supplemental Biologics License Application filing for the F8 formulation of tesamorelin with the FDA in the last quarter of 2023. With regards to Trogarzo lifecycle management, as previously said, the IV push method of administration for which we received FDA approval in October 2022 seems to be very well received by HIV providers and their patients alike. We're also working closely with our partner at TaiMed Biologics in completing the data analysis from this study related to the development of an intramuscular method of administration for Trogarzo and subsequent filing of a new supplemental BLA with the FDA. These projects will serve to ensure lifecycle management Trogarzo for years to come. Coming back to our pipeline development of TH1902, we are currently evaluating the changes needed to increase the probability of success of the clinical trial. The Scientific Advisory Committee will be providing expert advice and will be critical to examining different dosing strategies, tumors, and patient selections. These changes will be made in alignment with the FDA Project Optimus guidelines, ultimately improving the chance of success of TH1902. Let me speak for a moment about the Scientific Advisory Committee, as their collective experience and expertise in the field will be paramount to the future of TH1902. In addition to the study's principal investigator, the SAC includes several medical oncologists from across the U.S. who are leading experts in the end-to-end life cycle of oncology drug development. We will also continue to seek advice and input from Mace Rothenberg, who is currently a scientific advisor to Theratechnologies. Most recently, the company has been preparing response to questions received by the FDA. This work is well underway, and the findings will be considered by the SAC as part of their meeting, which is scheduled for the latter half of March when the data analysis are expected to be ready. Once expert advice is considered, we plan to promptly amend the protocol and resubmit to the FDA. I also want to add in here that the FDA has agreed to responding to us within 30 days of receipt of our submission. Our commitment to resuming our phase 1 clinical trial for TH1902 remains strong, and we are confident that by having an improved protocol will increase our probability of success. Let's turn our heads to a re-energized part of our pipeline. The further development of tesamorelin allows Theratechnologies to maintain its positioning as one of the few options for drug developers to immediately partner with a company in order to launch a phase 2b/3 NASH clinical trial. What is more amazing is the fact that repeatedly, quarter after quarter, NASH was losing momentum as a target within the life science investment community. That suddenly changed in the past few months as several companies reported extremely positive NASH data from their clinical trials, putting the disease back in the spotlight and highlighting partnering opportunities for our NASH program. When we compare our NASH candidate to that of our competitor, the liver fat reduction percentages are favorably comparable. Taking this into consideration, we remain extremely optimistic about partnership prospects in 2023. To wrap up my portion this morning, I want to reiterate that we are on track to achieving positive adjusted EBITDA by the end of this fiscal year. I want to thank our hardworking teams for their commitment to our goals that are ultimately to the benefit of improving the lives of the patients we serve. We have a path forward for returning TH1902 to the clinic. I wanna thank our investors and industry partners who have been on our side over the past few months. We appreciate your support and your feedback. I will now pass the microphone over to Philippe, our CFO, for his input. Thanks, Paul. Good morning, everyone. Consolidated revenues for the fourth quarter of our fiscal year 2022 were $21.4 million, up 14% versus Q4 of 2021. We are pleased to report that revenues from EGRIFTA SV sales were $14.5 million in the quarter, up 13.4% from the same period last year. Increased sales of EGRIFTA SV were the result of higher unit sales and a higher net selling price. Trogarzo revenues in Q4 2022 came in just shy of $7 million, up from $6 million in the same period of 2021, representing an increase of 16%. Recall that during the fourth quarter of fiscal 2021, Trogarzo net sales were impacted by a provision related to greater than anticipated clawbacks on units sold in France prior to finalization of reimbursement terms pursuant to Temporary Use Authorization. Trogarzo sales in the fourth quarter of 2022 were up marginally in the US and were affected by lower inventory levels at our distributor at the close of the quarter and slightly higher rebates to government payers. As our first quarter is ending today, I can confirm that we are happy with unit sales for the quarter and that we are on track to meet our recently announced guidance of $90 million-$95 million, representing growth of approximately 13%-19% compared to 2022 revenues. Cost of goods sold in Q4 2022 was $5.9 million compared to $5.2 million the same quarter last year. The increase is mostly due to certain write-downs during the quarter of inventory related to the manufacturing of pre-launch batches of the F8 formulation of tesamorelin. R&D expenses amounted to $9.5 million in Q4 2022 compared to $8.7 million in the same quarter last year. This increase is largely due to higher spending in our oncology program, including the phase 1 and the human factor study for EGRIFTA SV, and also spending related to the development of the intramuscular formulation of Trogarzo. In Q4 2022, selling expenses amounted to $7.8 million compared to $8.2 million for the same period last year. The decrease in selling expenses is largely associated to the decision to exit the European market in 2022 and is somewhat offset by higher spending to support our commercialization efforts in the U.S. G&A expenses amounted to $4 million in Q4 2022, up from $3.5 million in Q4 2021. The increase is due to an overall increase in activity to reflect the growth of our business in North America related to the onboarding of our field force during 2022, which is offset by lower spending in Europe. In Q4 2022, net finance costs were $2.1 million compared to $1.8 million in Q4 of 2021. The higher net finance cost is mostly due to the increased interest rate paid on our long-term debt compared to the interest paid on the convertible debentures in 2021. Net loss for the quarter came in at $7.9 million compared to $9.9 million in the same quarter last year, mostly as a result of higher sales and gross margins in 2022 compared to 2021. We ended the fiscal year with cash bonds and money market funds of $33.1 million. As mentioned before, we anticipate in ending the year on a solid path to becoming adjusted EBITDA positive. We believe our continued anticipated top-line growth, combined to lower spending, mostly in research and development, will help achieve this objective. In particular, we should complete many important projects in the first half of this year, including the development of the IM mode of administration of Trogarzo, both human factor studies for EGRIFTA SV and for the F8 formulation, as well as the development of our own source of Bacteriostatic Water for Injection necessary to reconstitute the F8 formulation. The completion of these projects, along with the stated goal of partnering our clinical development programs, should allow us to benefit from substantial leverage from our operations in the latter part of 2023 and through 2024 and 2025. We also announced this morning that Marathon had removed the filing of the HFS with the FDA as a condition to access the second tranche of the term loan for $20 million through an amendment to the credit agreement. As a reminder, the proceeds of this 2nd tranche are earmarked for the redemption of the remaining outstanding convertible notes due in June of this year. Paul Lévesque will be back for a few final comments after the question period. We're now ready to take questions from the line operator. Thank you. We will now take questions from analysts. To ask a question, you may press Star then one on your telephone keypad. If you are using a speakerphone, please pick up your handset before pressing the keys. To withdraw from the question queue, please press Star then two. At this time, we will pause momentarily to assemble our roster. Today's first question comes from Louise Chen with Cantor. Please go ahead. Hi. Good morning, everyone. This is Kareem 'Karbi' Fakhry on for Louise from Cantor. Thank you for taking my questions. First of all, we're wondering if you could provide additional color in terms of your potential partners for Phase 3 NASH opportunity. Has there been any recent events or changes in NASH space that you think have impacted discussions with potential partners? Second, you mentioned that you are planning to tighten your spending moving forward. How are you thinking about OpEx in relative terms to fourth quarter numbers? Thank you so much. Thank you very much for your question. Let me just address your first question about part, you know, partnership for NASH. We have been active for a long time. You know, we've said that in previous calls. I just want people to understand that there's something significant that has changed, and it's the context. The context we believe is far more favorable now than it was a year or a year and a half ago. Once a lot of people, you know, started challenging the fact that maybe the mission was impossible when it came to NASH. With the data that was produced last fall by two active companies in NASH, I think has changed the perspective over the mission being possible. What we are saying is in that context, there are very, very few companies that are at the point where we are with a compound that has established its safety profile, that has a protocol that is ready to go with phase 2b/3, and also that has a dose that has been determined. We have a lot going for ourselves. We have secured IP as well for this new journey that we may start. I'm more enthusiastic than ever that we can find a partner in, you know, 2023. I can only tell you that we will devote a fair amount of that, you know, our efforts to make that happen. We've got a lot of contacts, and we'll reach out. I think that there are some companies that were standing on the sidelines in the last 18 months that will come forward. At the very least, that's what I'm expecting. When it comes down to tightening expenses, I'll turn to Philippe for this so that he provides additional color. I said in my speech that we intend to drive leverage P&L moving forward. What we mean by that is definitely having the top line growing faster than the expense line. We've already factored that in in 2023. We will carry that philosophy forward in 2024 and 2025, and we have many one-off expenses that will go away as a function of time. Philippe, do you want to provide additional color? Sure, Karbi. It's mostly on the R&D that will be more reasonable in 2023 compared to 2022. Again, it's if you look at Q4, it might not be the best as comparator, but you, if you look at 2021, that's kind of where we think we'll end up in this year. A lot of that spending will be in Q1 and Q2. The spending will decrease in Q3 and Q4, again with the projects that are ongoing that should complete in Q2. Selling expenses, again, close to 2021 versus more or closer to 2021 than closer to 2022. SG&A or G&A, if you look at Q4, it's a pretty good proxy for what we'll have in 2023. Thank you for your question. Thank you. The next question comes from Andre Uddin with Research Capital. Please go ahead. Good morning, Paul Lévesque, Philippe Dubuc, John Leasure, and Christian Marsolais. It sounds like your NASH partnership discussions have picked up. Can you please elaborate on what ideally you're looking for in terms of a partner? Well, I mean, there's at this stage of the game, I think that the global partner is what we have in mind. You know, there's obviously many companies that have activities in Europe only, we could have that sort of geography split as well. You know, what is at play now is global partnership, and that is what we would like to embark. As you may know, when it comes to get the product approved in Europe, the guidelines from the agency over there is slightly different from North America. The protocol that we currently have developed under Christian's leadership has taken that into account and will be measuring as part of the trial, both the NAS score and the impact on fibrosis. The protocol, you know, should be equipped to actually satisfy both agencies in due time. Philippe, do you want to carry on in terms of what would be an ideal type of partnership? Yeah, sure. In keeping with our objective to become EBITDA positive, we'd be willing to do some R&D and do some of the development with the partner. But the cost would have to be borne by the partner. It would be a neutral effect on our bottom line. That's really what we're looking for is for someone to share in the development and take some of the cost away from us. That's great. Thank you. Andre, I would like just to add that, as you know, the protocol as it stands now, we have embedded an interim analysis, after the first, 350 patients or so are treated and pick up data on fibrosis and the NAS score. To some extent, we believe that the full cost of the trial, if the signals are not good, will never have to be beared, either by ourselves or the partner, as Philippe indicated. Okay, that's great. Just maybe just another question here. Just could you please explain what would be required for the EGRIFTA SV HFS? Christian, do you want to? Yes. The HFS, it's, there are guidelines and what we have to do, we have to change the instruction for use. To ensure and test it with some patient people that have used the EGRIFTA in the past and people that have not used EGRIFTA in the past. We did a formative study indicating that the work that we've done so far is very good. Most of the patients passed the test. We submitted the protocol to the FDA. We're waiting for their feedback, and we're ready to do the test study. At the moment, our timelines are good for submission of the dossier by before mid-year this year. That's great. Just one last one. Go ahead, Andre. Sure. I was just gonna ask, maybe could you also discuss the next steps that would be required in terms of development of the intramuscular formulation of Trogarzo and how that's proceeding? Sure. Christian? Yeah. The, this stage, we completed the trial, then it's really a question of completing the blood analysis and the statistical analysis and completing the dossier for submission to the FDA. That should be done this year and seeking for approval from the FDA. That's great. Thank you. Thank you, Andre. The next question comes from Andre Lino with National Bank. Please go ahead. Hey, good morning. Thanks for taking my question. The first one I wanted to ask, I mean, Paul, you mentioned that you're looking at potentially new products to add adjacent to HIV or HIV-related ones. I mean, can you expand a little bit on that? What would be kind of an ideal product for your bid in terms of size, in terms of revenues, cost to acquire a mature or recently product? Like, just kind of like how do you think about it and what would be an ideal product for you to consider? Thank you, Andre. First of all, let me call this out and I'll turn to John, who's very active in that space to try to identify a good complement for the portfolio we have. I just wanna, you know, call this out is that we want to actually we are open to new business, but it's gonna have to be accretive. We want to have something that is typically already approved, that is on the market, typically reimbursed, but deprioritized by some of the major firms. You know, I'll turn to John, he's gonna tell you how we actually think about it so that it could be a good fit for our business. John? Well, Paul said it right. I mean, you just have to look at our two assets right now and, you know, similar products to that. These are deprioritized or at least EGRIFTA is certainly deprioritized by bigger pharma, smaller niche products that we can launch with a targeted sales force, so more in the sort of rare disease space. Again, they don't have to be, you know, necessarily HIV or in the metabolic space, but if they're adjacent to that, obviously we have expertise, that would be nice. We're looking at other categories as well. I think we're open to different things. We're also looking at potentially co-promote deals, where our sales force would other companies would take advantage of our commercial capabilities and sales force. Thank you, John. The bottom line here is that it has to be accretive, you know, generated, generating, you know, positive EBITDA, adjusted EBITDA, so that we don't have any setback in our journey to, you know, turn this organization, you know, positive from an adjusted EBITDA point of view. No, that's great. Thank you. Another question perhaps, still for John, I mean, it was also mentioned that, you know, you're looking to expand awareness and utilization of EGRIFTA and Trogarzo. I mean, the question there is that like, is there room to actually do that? I mean, EGRIFTA has been in the market for a very long time and Trogarzo for five years now. Like, how could you expand awareness more than what it already is? Well, first of all, I mean, we have a new sales and marketing team completely, so we're looking at new strategies all the time. We're looking at programs, as Paul mentioned, in activating patients through social media and creating awareness and driving them into physicians. This has proven to be very successful. There's also a lot of increased interest in weight loss drugs, in particular, the GLP-1s, which y'all may be familiar with. We're finding, it's causing increased interest in market expansion. We're seeing increased interest in testing with waist-to-hip to identify patients with lipodystrophy. There's a lot of things happening in this space. If you look at the amount of literature being published around weight loss and HIV, it's grown exponentially. I think for those reasons, I'm optimistic. Similarly, if you look at Trogarzo, there's increased interest in long-acting injectable products and new ones are being released, and that sort of opens up the market to new possibilities of combination therapy that never existed before. For both those reasons, I'm fairly optimistic. Okay. That's great. Thank you. One last for me. Is there any way you can give us guidance on, I mean, guidance in the sense that for 2023 sales, could you possibly break down the growth, what you expect between price and volume there? That's it for me. Thank you. we've taken price increases on January first of 7%, and so the rest should come through unit growth sales. Okay, great. Thank you. Thanks, everybody. That's it for me. Thanks, Andre. Thank you, Andre. As a reminder, to ask a question, you may press Star and then one. Seeing no further questions, I would like to turn the call back over to Paul for final words. You have any questions? There was one. There's a few questions from the webcast, and most of them have been addressed, but there is one for on the TH1902 program. In a general sense, knowing that the SAC will be looking at the full data, in the CMO's opinion, what is the main issue with the construct of the PDC? Is it the SORT1 as a target, the linker stability, or the chemo agent that's not powerful enough? Any thoughts on what's happening here? I think that the construct of the PDC is the right one. We've done many, many tests in preclinical that we have seen that are very good and show very strong efficacy. What we have to do in the human, and the question for the SAC will be more related to the clinical data and what we've seen so far. It will be more linked to the frequency of administration of the drug. We do believe by changing the frequency on a weekly basis, we can show more efficacy. The selection of patient will be very important. As we have mentioned in the past, there are patients that have received more than 11, 12, or 15 prior cycle or prior treatment for cancer. This is normal in the dose escalation, but we certainly want to reduce the number of prior treatment in the new basket trial, the new part of this study. There will be also selection of tumor type because at the moment, we have seen signs of efficacy, and we'll certainly select the tumor type in which we have seen the best signs of efficacy. Okay. Well, thank you very much for attending this morning. Thank you, operator, and thank you everyone for joining us on this call and for being a part of our journey. We look forward to our next quarterly call with you and providing an update on our efforts. Thank you and have a great day. The conference is now concluded. Thank you for your participation. You may now disconnect your line.
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