Theratechnologies Inc.

Ladies and gentlemen, thank you for standing by. Welcome to this Thera Technologies conference call. At this time, all participants are in a listen-only mode. Following the presentation, we will conduct a question and answer session. Instructions will be provided at that time for you to queue up for questions. If anyone has any difficulties here in the conference, please press star zero, star, the star key followed by zero for operator assistance at any time. I would now like to remind everyone this conference is being recorded today, February 25th, 2001, at 8.30 a.m. Eastern Time. And I would now like to turn the conference over to Denis Boucher, Vice President, Communications and Corporate Affairs. Mr. Boucher, please go ahead.

Thank you and welcome. Mr. Paul Levesque, President and Chief Executive Officer of Terra Technologies, and Mr. Philippe Dubuc, Senior Vice President, Chief I. on today's call. A Q&A period open exclusively to financial analysts will follow their presentation. Before Paul begins his remarks, I've been asked by Terra Technologies to read the following message regarding forward-looking statements. I would like to remind everyone that Terra Technologies' remarks today contain forward-looking statements about its current and future plans, expectations and intentions, results, levels of activity, performance, In preparing these forward-looking statements, several assumptions were made by Terra Technologies and there are risks that results actually obtained by the company will differ materially from those statements. As a consequence, the company cannot guarantee that any forward-looking statement will materialize and you are cautioned not to play undue reliance on them. Terra Technologies refers to current and potential investors the Terra Technologies public filings. Forward-looking statements represent Terra Technologies' expectations as of February 25th, 2021. Except as may be required by securities laws, Terra Technologies does not undertake any obligation to update any forward-looking statement, whether as a result of new information, future events, or otherwise. I would now like to turn the conference over to Paul.

Thank you, Denis. Good morning, everyone, and thank you for being with us today. As we present the financial results for the fourth quarter of 2020 and reflect on our full-year performance, we are proud of what we have accomplished, especially in a year where a global pandemic challenged our business model. The company I joined less than a year ago has undergone significant changes. I believe these are technologies of the future will have little resemblance with the company of the past thanks to the continued progression of our pipeline. Last April, during my first quarterly call as CEO, I said that it would take 60 to 90 days to review our business model and identify the levers of success and investment required to fully recognize our potential. I quickly realized that COVID-19 or not, changes were needed to optimize the commercialization of our two unique products in HIV. It also became clear that to accelerate the sales performance of both Agrifta and Drogarzo, much more patient and HCP education was required to properly establish the benefits of our medicines. As such, in the second half of the year, changes were implemented to adapt our business model and increase our digital and virtual marketing initiatives. The goal is to improve patient outcomes by building upon real-world evidence to inform guidelines and advance the care of people living with HIV in the pandemic environment. For instance, as telemedicine consultations between HCPs and patients increased, we launched tools to allow both doctors and patients to have meaningful conversations about treatment options and to better understand patients' conditions, initiate their treatment with one of our HIV medicines, and maintain their compliance. We added to our education program the latest information which links visceral fat to worsening COVID-19 symptoms severity. This is an important message that supports the urgency to treat visceral fat as a serious metabolic condition, particularly during the pandemic, and to differentiate it from a lifestyle disease. As for Trigarzo, we have deployed a similar approach by developing online tools and virtual events aim at educating HCPs and patients on the importance of maintaining a non-detectable viral load. For people living with HIV, a detectable uncontrolled viral load can have huge implications on their overall health, and these viral mutations are at increased risk of HIV-associated morbidity and mortality. In fact, we branded a new program called V equals V, which stands for viral load equals vulnerability, and we keep selling Trigarzo's long-acting profile as a key benefit versus a competition. We're also developing tools to help HCPs identify people with multi-drug-resistant HIV that have exhausted options to treat their disease. The goal here is to create a sense of urgency for doctors to treat their uncontrolled conditions. Our new approach in patient activation leverages HIV digital influencers and social media to drive patient self-identification and request. Furthermore, our new community liaison team performs a digital outreach to case managers in high prevalence area to help identify patients at risk of lycophystrophy or a detectable viral load. With these, we wish to empower patients to own their conditions. which will lead to superior interaction with HTPs and ultimately a better outcome. The changes and improvement I just mentioned could not have been accomplished without the well-integrated cross-functionality between our sales, medical, and marketing teams. And as a result, our commercial business is now far more efficient at reaching out to patients and HTPs in a more virtual environment. However, like many other companies in the healthcare space during this pandemic, Limitations to having face-to-face interactions have made it challenging to recognize more robust sales growth. The urgency to treat multidrug-resistant patients is not well understood in the HIV community, and physicians may lack resources to trigger a change. In fact, a main barrier that we have experienced through the pandemic has been getting patients initiated on Trogazo. In order to initiate treatment on Trogazo, a patient must be screened at the hospital or clinic However, patients have been asked to stay home while hospitals are overwhelmed with COVID-19, thereby delaying and in most cases impeding the patient's ability to start treatment. Unsurprisingly, a similar paradigm emerged in Europe during the year. As strict lockdown measures were imposed in many European countries, we saw the impact from COVID-19 delay the review of our regulatory dossier for Tregazo thereby impeding our ability to launch our medicines in additional countries outside of Germany. Patient identification is key, and we wish to build a strong base of patients ready to get on Tregazo as soon as lockdown is lifted. Looking ahead, we will continue to work towards obtaining reimbursement for Tregazo in other key European countries, and will remain focused on improving our U.S. and European sales infrastructures to adapt to this new pandemic-imposed business environment. Now, before turning to the pipeline, let me touch upon the financing exercise we completed last month. As announced on January 19, we closed a bought deal offering of approximately $46 million to help fund our R&D activities, commercial initiatives, and work in capital needs. As mentioned moments ago, we have identified opportunities to invest in the life cycle management of our HIV medicines and enhance our marketing initiatives to continue to build our competitive position in the niche HIV markets we serve. Strengthening our cash position through the offering helps us to further support our HIV franchise. As we look towards 2021, we acknowledge that we're entering a huge inflection point for the company with the initiation of two significant pipeline programs. A phase one study in oncology that has the potential to progress quickly and a much larger late stage clinical study in NASH. The recent offering ensures that we have the adequate resources to initiate our clinical programs for these disease areas. We firmly believe that our current commercial assets continue to hold tremendous potential and our pipeline programs will prove to be significant value drivers for the company going forward. Through the January offering, we are now well positioned to successfully execute on our 2021 business strategy and objectives and build significant value for our shareholders. Our pipeline is a strategically important part of our value-driving objectives, and we are very excited about its prospects. In oncology, as we announced a few weeks ago, our lead peptide drug conjugate, TH19O2, received fast-track designation from the FDA as a single agent for the treatment of all sorts of positive cancers. As per the FDA's website, the fast-track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill unmet medical need. The purpose is to get important new drugs to the patient earlier. The FDA's Fast-Track designation opens the door to many benefits, including more frequent meetings with the FDA to discuss the drugs development plan and ensure collection of appropriate data needed to support drug approval. More frequent written communication from the FDA about such things as the design of the proposed clinical trials and the use of biomarkers. Eligibility for accelerated approval and priority review, if relevant criteria are met. And finally, rolling review, which means that the drug company can submit completed sections of the new drug application, the NDA, rather than wait until every section of the NDA is completed before the entire application can be reviewed. It is particularly remarkable to have obtained a fast track designation for such a broad indication based solely on preclinical data. To assist with the execution of our phase one clinical trial, we have contracted with a well-recognized global CRO. We expect to be in a position to deliver results for the dose escalating part of the trial around the end of 2021. Through our SORT1 positive technology, we believe that we have developed a fit-for-purpose peptide that could change the way cancer is treated. But as you know, this is only one element of our pipeline. There is also our NASH program, which we believe may provide another opportunity to bring an innovative treatment to an area of high unmet need. On January 7th, we announced that we had received a study may proceed letter from the FDA for the phase three pinnacle trial up to Sam Orlin for the treatment of NASH. As per the FDA's recommendation, we have requested a meeting with the agency to discuss the fine details of our protocol to ensure that we enter phase three development fully aligned with their expectations for this trial. We also plan to discuss with the European authorities to ensure that we can have a common program in both territories. Our goal remains to initiate the phase three trial in the third quarter of this calendar year. In addition to our pipeline, the development of a multi-dose pen injector that will be used with the new F8 formulation of the Samorin is progressing well. We still expect to file for supplemental biologics license application in early 2022. It is clear to me not even taking into account the NASH indication that the FH formulation in the multidose pen injector has the potential to change the way physicians look at the management of visceral fat. Furthermore, in conjunction with our agreement with PyMed Biologics, we also continue to make progress evaluating an IV push formulation of Trabarzo and expect a study for that indication to be completed in the third quarter of 2021. Following that time in, Theratechnologies are planning to evaluate an intramuscular method of administration for Trigarzo. That study is expected to begin in the first half of 2021. Our objectives in 2020 were ambitious and have been met or exceeded on the strategic front to advance the pipeline and prepare for the future of Theratechnologies. Let's now turn to Philippe for fourth quarter and full 2020 results.