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spk06: 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.
spk04: 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.
spk05: 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.
spk04: Good morning, everyone. Our last quarter was our best ever, and the same holds true for our last fiscal year. In fiscal 2020, we recorded net sales of $66.1 million, representing an increase of 4.5% from the previous year. Net revenues for Agrifta SV were essentially flat in 2020 compared to 2019. We recorded $35.4 million in net revenues from the Agripta franchise compared to $35.5 million last year. As for Targarzo, annual net revenues were up approximately 11% reaching $30.7 million in 2020 compared to 27.7 in 2019. Cost of sales slightly increased reaching $26.9 million in 2020 from $26.1 million the year before. Higher cost of sales is a reflection of production costs related to the manufacturing of GMP batches for our oncology platform. Cost of goods sold, on the other hand, was lower as Agrifta SV carries higher gross margins than the original formulation of Agrifta, and Progarzo gross margins increased in the latter part of the year, given the achievement of a predetermined net sales milestone amount in the third quarter of 2020. Selling expenses remained fairly stable and were up by approximately $400,000, reaching $26.9 million in 2020 compared to $26.5 million last year. In 2020, R&D expenses increased to $18 million compared to $10.8 million the previous year. The increase in R&D expenses is largely due to our oncology program, the development of the F8 formulation and multi-dose injector, our NASH program, as well as increased regulatory expenses and medical activities in Europe. G&A expenses grew to $12.2 million compared to $8.3 million in 2019. This is a result of the transition to a new CEO, the listing of our common shares on NASDAQ, and an increase in activities in Europe. Financial expenses for the year were down slightly to $5 million compared to $5.1 million last year. These include the interest payment on our convertible notes and a non-cash accretion expense of $2.1 million. These costs were offset by finance income of $300,000. In 2020, we recorded a net loss of $22.7 million, or 29 cents per share, compared to a net loss of $12.5 million, or 16 cents per share, in 2019. Operating activities used $13.6 million of cash in 2020 versus $3.4 million last year. Our operations used $7.3 million, while changes in operating assets and liabilities used $6.3 million. While increase to receivables and prepaid expenses were mostly offset by accounts payable and accrued liabilities, inventory build-up used $4.9 million, mostly due to the build-up of inventory in anticipation of the Tricarzo launch in Europe. Other uses of cash for the year were the payment of interest on our outstanding convertible to venture and the payment of a $3.5 million commercial milestone to time it. We ended the year with a cash and equivalence balance of $20.8 million. Given the capital raised in January 2021, our pro forma cash balance as at November 30th, 2020, was approximately $63.5 million. Looking at our Q4 numbers, total net sales reached $19.1 million compared to $16.4 million for the same quarter last year, representing an increase of 16.5%. Net sales of Egrifta rebounded nicely in Q4. They amounted to $10.8 million in the last quarter of 2020, compared to $8.7 million for the same quarter last year, representing an increase of 23%. For Garza, sales in Q4 2020 were $8.3 million, compared to $7.7 million last year, an increase of 9%. Cost of sales in Q4 2020 was down slightly to $6.7 million compared to $7 million for the same quarter last year. The decrease is mostly due to higher gross margins on EGRFTA SV compared to EGRFTA as well as a lower transfer price for Tragarso as previously mentioned. R&D expenses increased to $6.8 million in Q4 compared to $3.9 million for the same quarter last year This increase is largely due to the development of our oncology platform, BF8 formulation, and multi-dose pen injector, and expenses related to the development of tesamorelin in the treatment of NASH in the general population, as well as higher regulatory expenses and medical education initiatives in Europe. For the three-month period ended November 30, 2020, selling expenses were down to $6.5 million, compared to $7.7 million for the same period last year. The decrease is mostly associated with a transfer of resources from marketing to medical education activities. G&A expenses remain stable and stood at $3.3 million for the last quarter of 2020, compared to basically the same amount in the fourth quarter of last year. In Q4 2020, we recorded $1.4 million in finance costs compared to $1.3 million last year. And as previously stated, finance costs comprise interest on the convertible notes as well as accretion expense. For the fourth quarter of 2020, we recorded a negative adjusted EBITDA of $1.4 million, which is down from a loss of, an EBITDA loss of $3.2 million in Q4 of last year. The difference is mainly due to higher sales and lower selling expenses which were partially offset by higher R&D spending. I will now turn the call back to Paul for some closing remarks.
spk05: Thank you, Philip. I think that based on what we have just discussed, it is fair to say that Thorough Technologies has turned a corner. I would even dare to say that the Thorough Technologies of today is substantially different than what it was when I joined the company. In 2020, we have not recorded as much growth as we would have liked, and we remain cautious about predicting results in the upcoming months due to the COVID-19. The vaccination phase should be the beginning of the end for the pandemic. However, it will continue to disrupt normal HCP patient interactions, especially in hospitals and clinics, which are mainly devoted to massive vaccination activities. We are therefore building for the long run. and I am confident that we have implemented the required measures and taken the necessary steps to give us a stronger competitive edge post-COVID-19. I also think that the progression of our pipeline in the last year is nothing short of spectacular. In just a year, and in the midst of the global pandemic, we managed to file two investigational new drug applications, receive two Study Me Proceed letters, and obtained a fast-track designation for our SORT1 positive oncology platform. This fast-track designation for SORT1 positive recurrent advanced solid tumors that are refractory to standard therapy is a much broader starting point than anticipated and provides the chance to have regular interaction with the FDA. We also have obtained a study may precede letter for our Phase III program in NASH, We are now entering into final discussions with the agency and should be ready to go by the third Q of this year. Meanwhile, other key activities are all moving forward as planned. That is the development of the IV push and intramuscular administration of Tricarzo and the Tessamore and FH formulation in a multidose pen. All of these are key to our futures. 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. Over the last year, we have raised the bar to new heights for Thera Technologies, and we thank you for being part of our journey. We will now take questions from analysts.
spk06: Ladies and gentlemen, if you would like to ask a question at this time, please press star followed by the number 1 on your telephone keypad. Again, it is star 1. We'll pause for just a moment. You have a question from the line of Edward Nash with Canaccord Genuity.
spk01: Hi. Good morning, everyone, and thanks so much for taking my call and really appreciate the nice overview today. I wanted to ask you just a couple of questions on the HIV program, and then I can jump back into the queue if necessary for my other questions. But one of the things you talked about is the HIV program that you're spending a lot of time, have been now for some time, to customize those programs on the marketing side to help to basically show how and fit into what is currently now real-world practice, which I think makes a lot of sense. We're seeing a lot of that happening in design of NASH trials, which I cover as well. And so I think you guys doing this is great. As you're doing that, do you see these changes as staying put and being maintained the way they will be in their new form even after COVID? Or will there be a regression to the mean to kind of move back to the traditional marketing sales efforts that we normally see with drugs?
spk05: Well, thank you, Edward. This is a good question, and I'm happy to respond. You know, this sort of investment that we're doing now to establish the need for both Trabarzo and Egrifta will be longstanding changes in investments. Fundamentally, our business responds to medical activities, marketing activities and sales activities. Fundamentally, the medical activities takes a little bit more time before producing a return. Marketing is medium term and sales should be within weeks or months. It's the convergence of all of this that makes it powerful. That obviously takes time to have the right KOL in front of the HIV providers, tell your story once, twice, three times, have the chems that will be following up to closing the sales. And meanwhile, ensuring that the patient, as I said, will have more information to own their conditions and ask more powerful questions to the HIV providers. So as I said, I think that this is not a short-term plan. This is a long-term plan. outcome over a long period of time. And quite frankly, aside from the pandemic, which is slowing down some of the activities that we are putting forward, I have no concerns whatsoever. The market is going to react to our promotional and messaging in the upcoming months and years. Thanks for your question.
spk01: All right. No, that's helpful. I want to just follow up, if I could. Just with regard to the Trogarzo single bolus injection, it's good to hear that that trial is fully enrolled, and I know that that's under TimeMed's purview. But with regard to developing IM for that, is that really just a matter of chemistry? Do we know that that can be done? It was kind of the discussion I had with you guys on Tessa Morell, and when we were moving from the different generations of the F2, F4, F8, it was just a matter of chemistry. Is that the same here where we know it can be done, it just needs the time to be able to get that done?
spk02: Yes. Yeah, go ahead, Christian.
spk05: Thank you again for your question. This is more technical. I'll turn to Christian. Christian, go ahead.
spk02: Yeah, absolutely. And if you remember, Edward, we have presented some data at CROI about two, four years ago on an IAM injection process. in Taiwanese patients. And what we have to do now is to redo it in North American patients at the right dose, at the dose which is being approved. And in terms of the source of drug, it's the exact same thing. The difference with the IV slow push is that it's the concentrated drug product which is administered to the patient. The IAM will be the same thing. And that study will be initiated as soon as we, in the coming weeks with the IAM.
spk01: Okay. And I'm sorry, really last question just on HIV. Can you just make a comment on any off-the-cuff conversations you've had or any formal analysis you've done to see to what degree has there been any impact from recobia? I know recobia also needs another active drug, or obviously testosterone does. I'm sorry, trigarzo does. But just curious how much recobia has kind of, if it has, put a wrench in the works.
spk05: Yeah, well, thank you. I mean, from what we know, StamSphere was approved last year. They've been negotiating access. From what we know, they have not been put in a better access position than we are, position ourselves in on the plans, and they probably do not have the same coverage as we have because it takes a fair amount of time to get access with the numerous plans in the U.S., They share the same indication, which is not bad from my perspective because that should contribute to opening up the segment. The segment that we are in is multi-drug resistance. And Postemsevere will have to do a bit of what we're doing, which is educate the patients and the doctors for, you know, them to have a sense of urgency to change the triplets of medicines that they are currently using. And what we have that they don't have is a long-acting one. So a long-acting formulation allows you to have a better coverage. And a lot of people say that one of the reasons why a multidrug resistance has emerged is because of the lack of compliance. So if you use a BID medicine, you're directionally going in the wrong direction. going to continue to hammer our long-acting benefits, which will be translated into the IV push and eventually the IM formulation. So, again, I think that, you know, for stems of year, it's something that, you know, we're watching. We respect competition, but we'll fight competition. And I think that, you know, as long as the MDR segment increases, you know, we're going to be in good shape. Thank you, Edward.
spk01: Thank you. Appreciate it.
spk06: Once again, ladies and gentlemen, if you have a question, please press star one. You have a question from the line of Andre Uddin.
spk00: Good morning, Paul. Just actually wanted to ask you, what do you think would be your most important catalyst in the next 12 months?
spk05: Well, thank you for that question. I think that, you know, and having a chance to show the safety associated to TH1902 in human, and also early sign of efficacy is definitely something that will be a catalyst. And obviously, we know that we can proceed with the NASH study that we have put in front of the food and drug, because we received a study and we proceed, but we are refining the protocol now, and every bit is important for the future success of that program, so having a protocol approved that the FDA will like is also a key catalyst. And let me turn to Christian for additional color.
spk02: Christian? Oh, that's mainly also something that we've discussed in the past. With the oncology, based on our technology, what we have is we bring the cytotoxic specifically in the cancer cell, and in the animal studies we haven't seen any neutropenia. Then in the first inhuman, as you know, it will be a dose escalation. And as soon as we reach level where we would be in the zone where the cytotoxic alone, those attack cells would be toxic, if we don't see neutropenia, that will be a very, very good sign for the platform. As for the efficacy data, we need to wait a bit longer because even if we see something, we still need two, three months before we can confirm the efficacy. Then what we think for the oncology, End of the summer, probably some safety, and probably towards the end of the year, some efficacy data, which should be something that will be an important catalyst for the company. Thank you.
spk00: That's great. Thank you. And just in terms of a housekeeping question for Philippe, in terms of SG&A, If you look roughly at the run rate in the fourth quarter, should we expect that for 2020? Andre, this is Denny Boucher here. Would you speak a little louder because we can barely hear you? Okay, I'll pick up here. Just in terms of a housekeeping question, do you expect SCNA for the run rate in fourth quarter to be the same in 2021, roughly?
spk04: Yes, it should be in line. There might be a little bit more expenses in Europe, but in North America, it should be in line.
spk00: Okay. And also for 2021, do you expect any price increases for Greta or Tricarzo? I know that's hard to predict.
spk04: Well, we're not going to disclose that, but you could probably expect some, yes. Okay.
spk00: Okay, that's great. Thanks. That's all for me.
spk04: Thanks, Andre.
spk06: You have a question from the line of Indri Lino with National Bank.
spk03: Hi, good morning, and thanks for taking my questions. A couple for me. First, I was wondering if you can talk a little bit about Tregarso in Europe. First, how are the sales or what kind of receptions are you getting in Germany and any kind of initial forays in Norway? But also a bit of color on, you mentioned, I think, on prepared remarks, Paul, on patient identification for Tragardia in Europe. And then lastly, on that one, the post-authorization study for Tragardia. And the question I had there, I mean, is it more of an observational study, or are there any endpoints, how long it might take, and the cost? Thanks.
spk05: Thank you, Andrew. So the situation in Europe is unfolding nicely when it comes down to establishing the quality of the medicine that we have. And if anything, you know, through the launch convention that we had in Germany, where we had, you know, well over 200 attendants, the need for Tragarzo is clear. And what we're doing now, because we are in a lockdown situation, and that is mind-boggling, as you can imagine. But the patients have been identified. So we have a number of patients identified. We know how many we need to actually hit our objective. And quite frankly, I keep saying to the folks over there, do whatever you can do under the circumstances. As long as the patients have been identified, even if they are on the sideline for the time being, as soon as things reopen, they will be treated. And we obviously have a fair amount of patients treated on the early access program, especially in France, where we have a significant cohort under the ATU, so the temporary utilization approval, and that will continue. So we're building, you know, a number of patients now that will be getting out, tested, and getting on Travarso as soon as it reopens. And, you know, I can tell you from a scientific point of view, I'm very happy with what I hear. We have a team of MSL absolutely stunning in Europe, virologists for some of them in the different countries, Germany, Spain, France, and what have you. the science first, you know, I'm ticking off all the boxes at this time from that point of view. When it comes to submission to countries, some countries are overwhelmed at this time by COVID. So it is possible that some of our submissions will be late, you know, but again, we'll pick up pace as fast as possible and we'll try to maximize, meanwhile, before the drug is reimbursed, what we call the early access program. Thank you for your question.
spk03: Thank you. And just to follow up on that, on the post-authorization study, is it only an observational study, or are there any endpoints that you need to hit, and how much might it cost? Okay, I'm going to ask. Thank you.
spk05: I'll ask Christian to answer this one.
spk02: Thank you. For the registry in Europe, this is a registry that was requested by the European agencies, and the goal is really to look at the long-term efficacy. They wanted to be reassured that the efficacy of the drug will be maintained in the long term. We already have very good data up to 96 weeks that have been published, but they wanted to have data on the longer term. that's the goal. Then it's also safety, but safety, we know that this drug is extremely safe, but it's really the efficacy question. And the study is ready to wrap up in Europe.
spk05: And thank you, Andrew. And as a rule, these post-marketing surveillance trials are very positive because they allow you to build a network of leaders, KOLs, people interacting with patients and other colleagues, building confidence into a new medicine, and that's precisely what we're going to try to leverage.
spk03: Great. Thank you very much for that caller. And one more for me. Is it possible to provide any information? I mean, if there is anything new on discussions that you might have had with the EMA Fortress of Maryland in NASH, in terms of kind of are there any points of divergence between them at the FDA that you're looking to bridge before you start this trial? And that's it for me. Thank you.
spk02: Thanks, John. Well, in terms of new knowledge, we already have submitted the kind of the package if you want. We have a scientific advice for HIV. We know their position. We know their questions. We're comfortable in addressing their questions. And that will take place in parallel with our discussion with the FDA to ensure that we have a common clinical program mid-year for a start of the study in the third year.
spk03: Thank you very much.
spk06: If there are no additional questions at this time, I'm sorry. We have a follow-up question from Edward Nash.
spk01: Hi. Thanks. Sorry for that. I appreciate you doing the follow-up. I just wanted to ask a couple of quick questions just for timeline standpoint. So the supplemental BLA for the F8 pin injector, I'm thinking, given when you're looking to submit, that we should have potential approval, if there are no hiccups, by the end of 22 or early 23 at the latest. And I just wanted to know, would you guys be launching that immediately for Tessa Morellen, or would you hold off for a little bit since we've just had the new formulation on the market for not that long so far?
spk02: At the moment, in terms of completing the file for the submission of DFA, we want to have a one file combining both the drug and the device, the multi-dose pen. That should be, and we're targeting an approval probably more towards the end or the second half of 2022. And the goal will also be to prepare the market for something like this. We think, as Paul mentioned before, that this is certainly something that should have an impact, both for physicians and patients, and we'll be preparing a launch so it could be launched as soon as it is approved by the FDA.
spk05: So we intend to launch it for the indication we currently have, you know, and do the switch a bit like what we did between the F1 and the F4, so the ESG formulation. When the pen and the new formulation becomes available, we will be using it as soon as it becomes available part of the NASH trial, but we will actually make a submission for GRIFTA so that we can enhance the patient experience, and we believe that this will be significant.
spk01: Yeah, no, discussions I've had with HIV docs, you know, I think they were pleased with the going to the F2 to F4, but F8 definitely kind of changes the whole game. And so I think that's great to know you guys will be coming out with that directly. And my last question is I know, you know, it's not currently in my model, but this year we are going to start to really get some meat on the bone with regard to the oncology programs. And I just wanted to see, I know with 1902 that you're in preclinical with melanoma and that you've got, you're looking at multiple solid tumors, endometrial, ovarian, colorectal, pancreatic. Just wanted to understand the differentiation with the conjugate docetaxel in 02 and doxy with 04. What would 04, where does 04 fit in? I know it's earlier stage, but just kind of to better understand the complete landscape of the two programs you have right now.
spk05: Well, thank you. That's a good question. Quite frankly, you know, before entering what 1904 can be used for, we have to see how far we can go with 1902. And quite frankly, you know, with the fast track that we got and the type of, you know, label associated to that, 1902 has wide application. So quite frankly, we continue the progression of 1904 and drug conjugate. But first and foremost, we're trying to see the full potential of 1902 with the overall objective of bringing that to the market as fast as possible. So, Christiane, do you want to add anything?
spk02: Yeah, no, this is exactly what we have to do. And maybe the reason is because, like, at the beginning when we bought the company, we had very limited efficacy data on both. We had efficacy data with 1902 only in breast cancer and 1904 only in ovarian cancer, and this is the way that was positioned. But since then, with the work that was done and the additional research, we clearly see that 1902 has a much broader potential than what we initially were thinking. As Paul is saying, I think that we have to to see the entire potential of 1902.
spk05: But we will carry on our strategic thinking as Christian continues to establish confidence with 1904, and I'm sure that we'll have, you know, co-positioning at the right time.
spk01: That's great. Thank you guys very much, and congratulations in getting a lot of clinical and structural work done in a really hard year.
spk05: Thank you. I appreciate it. Thanks for your support.
spk06: And there are no questions at this time.
spk04: Well, thank you very much. If there are no additional questions at this time, we will conclude our call this morning. I would like to thank everyone for being on the call today. On behalf of everyone here at Thera Technologies, I wish you a very good day.
spk06: Ladies and gentlemen, this does conclude today's conference. You may now all disconnect. Thank you for your participation.
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