Theratechnologies Inc. (TH) Earnings Call Transcript & Summary

Good morning, ladies and gentlemen, and thank you for standing by. Welcome to Theratechnologies Fourth Quarter and Annual Fiscal Year 2021 Earnings Call. [Operator Instructions] I will now turn the call over to John Mullaly, LifeSci Advisors. Mr. Mullaly, Please go ahead.

Thank you, and welcome. Mr. Paul Levesque, President and Chief Executive Officer of Theratechnologies; and Mr. Philippe Dubuc, Senior Vice President and Chief Financial Officer, will be the speakers on today's call. Before Paul begins his remarks, I've been asked by Theratechnologies to read the following message regarding forward-looking statements. I would like to remind everyone that Theratechnologies' remarks today contain forward-looking statements about its current and future plans, expectations and intentions, results, level of activity, performance, goals or achievements or other future events or developments. In preparing these forward-looking statements, several assumptions were made by Theratechnologies, 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 place undue reliance on them. Theratechnologies refers current and potential investors to the forward-looking information section of its management discussion and analysis issued in this morning's -- issued this morning available on SEDAR at www.sedar.com and on EDGAR at www.sec.gov. Forward-looking statements represent Theratechnologies' expectations as of February 23, 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. I would now like to turn the conference over to Paul.

Thanks, John, and good morning to everyone joining the call today. I wish you a warm welcome and to express our thanks for taking part in Theratechnologies' journey. This has been an incredible year of milestone achievements in addition to the progress made in support of our commercial franchises. We want to focus your attention today on 4 key updates, which we believe are the major drivers in propelling our success in the new year. The drivers include the build-out of our own commercial sales and medical teams, our full year 2021 results, particularly our second half performance versus that of the first half, updates for our lead oncology asset, TH1902, and the progress in our NASH program. As we already draw near to the close of Q1 of our new fiscal year, we carry with us the full momentum of 4 successful quarters of progress. What stands out the most about Theratechnologies is just how differentiated we are in being an early-stage biotech as we possess both late- and early-stage assets. Moreover, in addition to our pipeline development, we're also a drug company with mature commercial brands and a strong strategy to grow our franchises for years to come. I am mentioning this now since we have recently announced the strengthening of our global commercial capabilities through the launch of an internal field force. Our commercial business has reached critical mass, and we look forward to kick starting our new stage of growth with this initiative. At present, we are finalizing our employment offers to top performers of the current sales force who will be joining the company from our partner contract sales organization. This will be in addition to the hiring of new experienced sales representatives in order to create a truly competitive field force. We do believe this will ultimately lead to superior performance and faster growth from our commercial portfolio. In parallel to this push to better serve our patients and health care providers, we're also strengthening our medical affairs team. We fully expect the expansion of our disease awareness initiatives, [ more ] ramp-up knowledge of the therapeutic field we are invested in across the patient and provider landscape. For example, we expect our PROMISE trial in North America and Europe for Trogarzo and the VAMOS study for [ HIV ] will contribute to helping health care providers identify patients in the diseases that we treat in building real-world evidence for assets, we are reinforcing the value they provide to patients, encouraging them to start and stay on therapy. We are optimistic for what lies ahead in the new year, coupled by a positive post-COVID momentum, especially now that face-to-face meetings have resumed across most states. In making the decision to transition from a contract field force model to one staff by Theratechnologies employees, we are confident that the hiring of our owned field, sales and medical affairs teams will significantly improve the important task of engagement with our customers. We believe that both recruitment and retention of top talent will also improve as we begin this new chapter of the company's corporate development. In summary on this topic, as our new sales and medical affairs colleagues are integrated into the fall, I would like to express how delighted we are to welcome these key members of our contract field force into the Theratechnologies family. While 2021 overall growth was 5.7%. The second half grew 10% compared to just 1% in the first half versus 2020. In addition, new patient enrollment across our franchises grew a blended 24% in the second half of the year as compared to the same year ago period. This is a very good sign that with post-COVID promotion, we are gaining traction in the marketplace. Growing revenues and the execution of our commercial strategy in the new year remains a high priority as we move swiftly to catch up with demand for Trogarzo [ and cryptic ] in patients with unmet needs. As a side note, capital access is very difficult in the current volatile biotech market. However, revenues from our commercial business serves to support and derisk our pipeline development. This relative advantage of being a revenue-generating enterprise is that our commercial business allows us to be more selective in our capital allocation choices. On the clinical track, we're happy to report that our oncology program is close, very close to establishing the maximum tolerated dose or MTD and to initiating the Part B of the Phase I trial of TH1902. We are now in the final stages of TH1902's, Phase I Part A dose escalation study, evaluating our lead investigational peptide drug conjugate for the treatment of sortilin-positive cancers. In total, 4 patients in the trial have been administered significant doses of TH1902, at 420 milligrams per square meter, equivalent to nearly 2x the indicated therapeutic dose of docetaxel. To date, we have observed a dose-limiting toxicity, or DLT, in 1 patient, consisting of a grade 4 neutropenia lasting more than 7 days as well as other adverse events after more than 1 cycle at 420 milligrams per square meter. As a result, we have decided to pursue the study at the lower dose of 300 milligram per square meter or approximately 1.5x the usual dose of docetaxel. We currently are enrolling patients at this lower dose to confirm the absence of DLTs following the first cycle. Once MTD has been established a study protocol allows for immediate initiation of enrollment of the larger open-label basket trial. The basket trial will further assess the safety and tolerability of TH1902. Additionally, the preliminary antitumor activity of TH1902 will be evaluated for all patients as per the responsive evaluation criteria in solid tumors. Based on additional research we have conducted on the SORT1 receptor, we have submitted an amendment to the Phase I protocol to the FDA to include the following solid tumor types. Hormone positive breast cancer, triple negative breast cancer, ovarian cancer, endometrial cancer and melanoma with approximately 10 patients per tumor type. In addition, one arm will be added to include a mix of tumor types, including thyroid, small cell lung, prostate and potential of the high sortilin expressing cancers with 15 patients in total. The original trial design consisted of 40 patients across a selection of solid tumors, including colorectal and pancreatic cancers. The plan now is to enroll a total of approximately 70 patients in the basket trial in order to evaluate the potential antitumor activity of TH1902. As previously mentioned, we're also exploring the possibility of out-licensing development and commercialization rights for TH1902, in Greater China. We are very pleased to report that there has been solid interest on the part of Chinese companies and that discussions are ongoing with a number of different pharmaceutical and biotech companies. In addition to the geographic exposure gain from these dialogues, we're also in exploratory talks with companies seeking to leverage our peptide as a carrier to target cancer cells through SORT1 receptors. Looking at the potential of TH1902's internal development, outlicensing and partnering opportunities, we are optimistic in our approach to managing the development of TH1902, for the treatment of solid metastatic and refractory cancers both in the near and medium term. Moving on to our national update. You may have recently seen in the news that a company with interest in NASH published very interesting data. The investment community subsequently reacted very favorably. Based on this and other recent data published in the area of NAFL and NASH, we are seeing renewed interest and believe more than ever in the prospects for tesamorelin as the treatment for NASH as a treatment for NASH as experts continue to gain awareness of the tesamorelin as a NASH treatment option. While we continue to see partnering in non-diluted financing options, our Phase III NASH program, the company will submit in the upcoming days an amended protocol to establish an interim analysis of primary endpoints. The new trial design will include a seamless Phase IIb/III study, where the first 350 of the planned total 1,094 patients data will be analyzed by a data monitoring committee in order to assess the efficacy of tesamorelin on a smaller subset of patients. A decision will then be made to proceed with the study's remainder of the planned total 1,094 patients. While this doesn't change the total number of patients required to seek accelerated FDA approval of tesamorelin for the treatment of general NASH. It will serve as a substantial derisking event and will inform the continuation of enrollment while providing an indication of benefits to patients. In the meantime, we continue to seek an ideal partner with both the credibility and the capability to assist us with the NASH program going forward. And in covering our basis, we're also seeking financing alternatives to execute the trial up to the interim analysis on our own. Before I turn the call over to Philippe, I want to note that our objectives for fiscal 2022 remain crystal clear. From a development perspective, we're also continuing our line extension efforts to further develop the benefits or convenience of our products, which includes new formulations and mode of administration. In total, our program management strategies to develop the complete portfolio of assets with clear, immediate, near-term, medium and long-term catalysts that will benefit not only patients' unmet needs, but provide entry and exit opportunities for investors at line. With this, I would like to turn the call over to Philippe, who will provide a financial summary for the reporting period before moving to Q&A. Philippe?

Thanks, Paul, and good morning, everyone. Consolidated revenues for the fourth quarter of our fiscal year 2021 were $18.8 million, down 1.9% versus Q4 of 2020. As I will explain later, our top line for the quarter was affected by a provision we are taking related to potential clawbacks in France and which are directly related to our ongoing negotiations with the government for the reimbursement of Trogarzo. We are, however, pleased to report that revenues of EGRIFTA SV were $12.7 million this quarter, up 18.6% from the same period of last year. Increased sales of EGRIFTA SV were the results of a higher unit sales and higher net selling price, mostly a result of a combination of our higher gross selling price and lower rebates and chargebacks from government payers in the U.S. Trogarzo revenues were $6 million during the quarter, down from $8.4 million in the same period of 2020. Unit sales were down 7% year-over-year and were mostly affected by lower new patient starts during the COVID-19 pandemic. We are currently seeing clinics reopen and face-to-face meeting with physicians increased as a result of the general reopening of the economy. We are confident that Trogarzo unit sales will start growing again in 2022, even if the recent short-term lockdowns related to the Omicron variant has affected the market in December to January. The bigger impact to Trogarzo revenues was related to a provision we needed to take in anticipation of clawbacks related to early sales of Trogarzo in France. This provision is mostly related to the anticipated price to be negotiated with the French government, which is being affected by the agreed price of a competing drug. Negotiations with the French government continue, and we believe we will be able to conclude these negotiations shortly. As our first quarter will end in the next few days, I can report that Trogarzo unit sales have resumed growing after a difficult few quarters and that EGRIFTA SV unit sales have grown in the 20% range from Q1 2020 to Q1 2021. So with this in mind, we are announcing a revenue guidance for fiscal 2022 this morning and are expecting sales revenue of between 79 and $84 million. Cost of sales in Q4 2021 was relatively stable at $6.4 million compared to $6.7 million for the same quarter last year. The decrease is mostly due to production-related costs, which were incurred in 2020, but not in 2021. R&D expenses amounted to $8.7 million in Q4 compared to $6.8 million for the same quarter last year. This increase is largely due to higher spending in our oncology program, including the Phase I trial and the NASH Phase III preparations, increased spending in medical and patient education as well as higher medical affairs initiatives in Europe. For the 3-month period ended November 30, 2021, selling expenses have amounted to $8.2 million compared to $6.5 million in the same period last year. The increase in selling expenses is largely associated with the addition of senior personnel in North America to build a stronger sales organization as well as increased activities in Europe ahead of the launch of Trivarzo in key markets. G&A expenses amounted to $3.5 million in Q4 2021, up slightly from $3.3 million in Q4 2020. The increase is mainly attributable to the overall increase in business activities and increased activity in Europe. In Q4 2021, net finance costs were $1.8 million compared to $1.4 million in finance costs in Q4 2020. As previously stated, net finance costs comprised of interest on the convertible notes, foreign exchange variations as well as accretion expense and are offset by interest earned on our cash balance. For the fourth quarter of 2021, we recorded a negative EBITDA of $5.5 million compared to negative $1.4 million last year. The difference is mainly due to the higher net loss during the quarter. So reflecting the impact of the capital raise during Q1 of 2021, we ended the year with cash and cash equivalents of $40.4 million. So Paul will be back for final comments. But first, we will open the call to take your questions.

[Operator Instructions] Our first question comes from the line of Andre Uddin with Mackie Research.

Just had a few questions. When do you think we would see some Phase I 1902 safety data? And when do you think you would also start the Phase II/III NASH trial?

TH1902, as we said, is about to finalize its maximum tolerated dose and the basket trial, I think, is going to be following right after. Christian, do you want to provide additional color to that?

Yes, what we mentioned is that we have seen some DLT at 420 milligrams per meter square. We reduced the dose to 300 milligram per meter square, which is 1.5x the dose of docetaxel when given or administered alone, and this is a very good dose. And now we're proceeding with the study enrolling 3 patients looking at the DLT and the following 3 patients after that will be ready to open the basket trial. At this stage, based on the data that we have, we're not expecting any DLTs of 300. That will be known in the next 2, 3 months.

When it comes to your second question, the NASH, we are about to file the amended protocol with the FDA. We expect a 30- to 40-day response from them. And following that, we'll have pretty much everything that is needed for us to actually clarify our plan forward. But this is a major decision that we've made and that we are announcing today because we -- doing so will allow us -- 350 patients have been treated to have hard endpoint data, which is very, very significant. And being able to go with the Phase IIb/III seamless protocol allows us to carry on with the recruitment of patients and therefore, not waste time. So I think we're going step-wise now. First, to confirm that this amended protocol is fine with the FDA; second, ensure that we can finance one way or another, either through a partnership or other financial means support at the beginning of the trial, and we will certainly get back to you as soon as we have a final decision made when it comes to that.

That's great. Just also a couple of other questions. I was just wondering if there are any synergies with Rukobia and Trogarzo based on what was seen at the CRA conference this year?

Yes. The -- so what we present like at the moment of what we have shown in our pivotal trial in the 40 patients, we had combination of Ibalizumab and Rukobia. And even if those are the 2 only fully active agent, we can control the viral. It becomes undetectable. And we see that, that combination is more and more used in the market. We also work with scientists that are assessing the synergy or additive effect of different drug in in vitro models, and those data will be presented most likely later this year. At the moment, what I can say is that with Rukobia, we see an additive effect, which is very, very good.

Okay. And just one last one here. Just there was an independent Italian study last year showing that VAT levels predicted Covid ICU admission. And just wondering if there are any studies looking at EGRIFTA for this? And is there any law label use going on for EGRIFTA in this indication?

Andre, this is a very good question, and this was a very nice observation. And this -- there's the Italian study, but we had -- there were other also U.S. studies looking at the -- making the link between the significant amount of fat and more severe symptoms of COVID. And what we've done, it's really showing that VAT is not only cosmetic. It needs to be treated and physicians need to tackle that. And what we did, the medical team was able to talk to the [ QO ] about these data, these data was very well received. It was also included in our speaker program and the physician in our speaker program were able to talk about this. Then that's something which is important. And it shows that for like for us, it's in the HIV patient population, but that should be treated and making sure that it is reduced to the maximum.

Thank you, Christian. It further reinforces the fact that the VAT or lipodystrophy is a serious medical condition. So we're using the bulk of evidence in continuing medical education. And we think that more and more doctors will see for themselves that we are the only solution to treat lipodystrophy in HIV patients.

And our next question comes from the line of Endri Leno with National Bank.

A few for me, but I'll start with the first one for Paul, perhaps. The question is on the sales force. What is the rationale for internalizing the sales force? And what do you plan to achieve that you're not achieving through the CSO?

Well, anyone in business will tell you that contract sales organizations are fine, but normally, you use a contract field force for only a period of time, either before you transition to something else or because you have a new indication and you want to have a surge that is not permanent in the type of activities that you want to have for the long run. So our rationale was if we want to beat the competition, if we want to be relevant, we want to actually produce the type of growth that we want to set for ourselves, we need to have a very engaged, very competent, very relevant field force. And I think that we wanted to see if we could move these products before initiating the transition because this is a significant endeavor. And as I highlighted in the speech, we were extremely pleased with the results we got in terms of new prescriptions, new enrollments in the latter part of the year last year as soon as we could execute on our strategies and tactics when it comes down to interacting face-to-face with physicians. So to me, that was a trigger and what we foresee is more effectiveness, field force effectiveness, more synergy with the medical field team. And all of that together will actually, I think, trigger superior engagement and superior results. John, do you want to add a few things?

Yes. I mean, as with any product, I mean, having a highly engaged sales force is absolutely critical. And with a contract sales force, I think there's some inherent limitations. One, we had a fairly high turnover rate. And due to the nature of these -- the contracts could be somewhat transitory. And having our own people is going to be significantly -- be a significant benefit to these products. We also hired a VP of Sales last year that has significant experience in HIV. So we're in the process of building the capabilities of the sales force, and we think it's going to really pay big dividends in the coming months.

That is a great color. And one more follow-up on that. What would be the cost bump initially? And what kind of ROI are you targeting and any time lines you can give if you can to achieve an ROI with the internal life sales force?

Well, the cost is pretty much cost neutral because we did pay FD management fee to setting us to manage our operations. So we're no longer paying that. We do have to hire some more support staff. But the cost, in general, is neutral. It really is for the engagement, the lower turnover and the recruitment of top performers. So on a cost basis, it's pretty neutral, but it's really on the operations that -- where the impact is best seen.

Next question I have on Trogarzo. So first, if you can quantify what the flowback provisioning Trogarzo was this quarter, just more for modeling purposes. And the other question on Trogarzo is if you can give an update where it has gained reimbursement in Europe and what other countries are you targeting there?

Well, the situation in Europe is one country at a time. As you know, we got an indication for being able to commercialize by -- from EMA a while ago. But the negotiation is country by country. We've got some countries now where we have been able to negotiate a good price and no cap when it comes down to total number of patients we can recruit. There are some other countries where we have a good price, but we do have a cap. And there are some other countries in Europe, as you may imagine, where there's a direct relationship between pricing and volume. And for those, we are extremely careful before accepting an offering that would not allow us to actually promote for the long run based on the fact that we would not be able to reap the benefits of our investments. So we are negotiating with many countries. All the countries in Europe for which we have approvals are in scope, incidentally, we just negotiated a good price in Israel recently, and we will continue in smaller countries like Austria and like Norway, but the main countries for us in Europe is probably France. We find that there's a significant potential in Italy where we secured a price earlier last year, at the end of 2021. And we also have a great deal of expectation for a country like Portugal, that is a small country, but that carries a fair amount of HIV-1 patients. Spain is in scope, U.K. is in scope. And it's one country at a time, as I said, based on their way of negotiating. So we have to be customer-facing, customer-focused and it's one country at a time. And we'll let you know where it pans out in the end. But to answer your questions, all the countries are in scope. We just need to do the right negotiation and get out of the negotiation in a way where we could actually have a go-to-market model that makes sense for us. Now I think your second question had to do with Trogarzo and the potential clawback. Is that what I heard? Philippe, do you want to take that one?

Endri, we're not announcing the exact size of the provision. We're still in negotiation with the French government, so we want to keep that private for now. But what I can say is that we would have shown growth on the top line overall for the quarter if we hadn't had it. So that's all we're going to say right now.

No, that's good color. That's good color. And just a couple quick ones for me on the development products, and I'll turn it over to the line. But on the NASH, the modified protocol, is this in response to any feedback you received during discussions with potential partners? Or is it an internally developed strategy?

Well, it's twofold, I guess. We've been doing a fair bit of analysis to compare the benefits of doing a Phase IIb and then a Phase III trial. And quite frankly, a Phase IIb trial would be very similar to doing this interim analysis that we want to embed in our Phase III protocol. So we believe that we are good to go, and the agency believes that a long time ago because they gave us a study in the proceeds letter. But at the same time, chopping off the study in smaller bits from the financial point of view makes a great deal of sense and being able to have hard endpoint analysis after the first 350 patients are treated, makes also a lot of sense from both a science and a financing point of view. So we think that providing that the agency is fine with this approach, which is called seamless type of approach or protocol, I think we are going to have all the cards on the table for us to make a final decision. Christian, do you want to add to this?

No, I think that is.

Okay. Great. And then last one for me. On the oncology, the TH1902, the out-license in China, how imminent is this as a strategy, would you do it if you have content on the table at this point? Or would you wait until you have established the MTD and have some indication of activity from the PACE trial?

Well, thanks for the question. I'll let Philippe answer that question. We are in negotiation with many companies. Some of them are very happy with what they've seen and already we have terms. Some others, it may actually turn to we want to see more. But what can we say? I think the overall objective here was to get a Chinese partner because we're not going to develop ourselves for the Chinese market. So we wanted someone to get involved as early as possible have as much as possible a parallel development track. And so obviously, if we contacted probably 100 companies and some of them said, we'd rather wait for Phase I data, but some of them are willing to take the risk. So we don't see why we should wait because there will be milestones associated to every regulatory and development hurdle that we go through. So really what we wanted to achieve was have someone as early as possible in the development so that they could help us bring the product forward on a global basis. So in... this is a value-generating strategy that we want to put forward.

And I'm showing no further questions.

Okay. So we'll take a few questions from the web platform, and there's quite a few on the oncology trial in terms of the selection of the de cancers that we'll be putting into the Phase Ib trial. So I'll read and paraphrase a few of them. So can you please clarify the Phase Ib cancer types and what informed the decision to add more types and to drug pancreatic and colorectal. And was that -- was it something that was seen in the trial or other work that you did?

Yes. Well, thank you for the question. This is an important announcement that we've made today. And I wouldn't like anybody to actually see this as a drop of colorectal or pancreatic. You should see it the other way around. What we've done is that we are optimizing our basket trial to see early sign of efficacy, based on the sort on work that we've done to measure the expression of that receptor. Christian, do you want to say more?

Yes. So, If you remember, the protocol was submitted to the FDA and completed a bit more than 1.5 years ago. But since then, we've done many, many analysis on different tumor types. And what we have seen is that, that sort of sector is significantly expressed in a large number of patients in all of the cancers that we've selected for the Phase I. And as Paul said, it's a better chance to have a sign of efficacy, but it's also a better chance to have a fast track to the FDA without a diagnostic test. And that's the goal at the moment. And maybe just for colorectal cancer or pancreatic cancer, we've seen some expression, but it's only in the lower percentage of patients eventually, with the diagnostic test that could work as well. The initial goal is fast to market and the cancer types that are expressing the most of this [ work the end]. So this is a very important point in today's conversation. We are just highlighting some -- or integrating some new learnings into our protocol so that we increase our chance of winning and driving an indication as fast as possible.

And maybe just to close on that, we are planning to either publish or present the results from the Sortilin work that we've been doing. So do you expect INR902 IND to be for all SORT1 or expressing solid tumors? Or will they be a Phase II, Phase III for each cancer type Jim?

Yes. This is a very good question. It will depend on what we see in our basket trial. At the moment, most drugs are developed tumor type by tumor type. If we see more efficacy in one tumor type, we might use that approach because it will be faster to market. If we see similar efficacy in many different tumors, there could be a kind of a basket approach as well. But I think that it will most likely be a one-type cancer for the past.

Okay. On TH1902, again, how serious were the adverse events in the cycles after the initial cycle?

Yes. What we've seen is our adverse events are linked to when you give a higher dose of docetaxel, at some point, you cannot reach or go higher to a certain level. And what you see with docetaxel, we've seen the same after 2, 3 cycles at to the signs of nerve toxicity that's seen with those impact. We've seen also some signs of digital electivity, same with docetaxel and some fatigue. Then we have a regular discussion with all of the investors taking part of the study and based on that observation, we decided to go to the 300 milligram per meter where we think that even if it's a 1.5x the dose of docetaxel, it will be much better tolerated, and we'll be able to give way more cycle at the 300-milligram square, which is the objective in treating advanced cancer patients.

A question here. Will you be looking at other applications for the SORT1 receptor outside of oncology?

We know that there could be some other applications based on SORT1 expressions in other parts of the body. But quite frankly, we've got our hands full now with SORT1 expression in oncology and its potential. You also heard that some companies have shown interest in our peptide as a carrier to get to the cancer cells. And we'll have to do a fair bit of education on the SORT1 receptor as we get into the basket trial so that people can understand how it works and why we have identified this entry to the cancer cells, while the vast majority of companies have not. So we've got to be very, very prudent here in the way that we spread ourselves and there are many additional applications outside of cancer, but this is not part of our journey at this time. Christian? Okay. How long will it take to confirm safety at the 300 milligram level as you give a time line? Christian.

So, I think what -- the way the product as said is what we recruit 3 patients. We need to hold them for 3 weeks, and there is no new -- we go to the next 3 patients hold them for 3 weeks after we will be ready for the basket trial. I think the one thing that we have to be careful in terms of time line, sometimes we have a patient who is almost ready to start, and there's a significant progression of the condition and the patient has to be excluded from the trial that there could be a bit more time in recruiting the patients. But I think within the next 2, 3 months, we should be able to confirm as we're moving ahead with the basket trial.

I want people to understand. Thank you, Christian, that the dose escalation, unfortunately, is not always a straight line, and it could mean sometimes as you go one step forward to have one step backwards. And it looks like now we are really at the end of this process. So we need to confirm what just Christian highlighted in the next couple of weeks. And as soon as that confirmation is done, we'll actually start opening up at a different pace towards the basket trial.

So last question on oncology, any upcoming conference presentations on cancer? I'm going to answer that. We can't really answer it, but we'll tell you that AACR is coming up and ASCO is coming up in June as well. So that's all we can say on that for now. There's a question on the estimated cost of pursuing the first 350 patients in NASH. And we're still working with our CRO on contributing the exact cost, but it should be in the $50 million range. So about 1/3 of the overall cost then for 1/3 of the patients. And there's a question on the impact, again, on the cost impact on the sales force transition. As we said, there are a little bit of some upfront cost to set it up. But on a go-forward basis, it should be a cost control. So that confirms the -- concludes the Q&A session. So I'll hand it back over to Paul for closing remarks.

Well, thank you to everyone who joined our call today. We hope that we have clearly articulated that the 4 main drivers of Theratechnologies 2022 strategic operating plan. Our marching orders are rather clear and focused on these drivers, which includes, firstly, the rollout of our newly established internal sales and medical field force in support of our franchise activities. We believe our internal sales force will allow the company to be even more competitive in 2022 and beyond as we flex our superior ability to connect and engage with patients and providers in order to improve therapeutic outcomes. Second, from a financial metric perspective, it is our intent to build upon the momentum of the second half of fiscal 2021 and are targeting from 13% to 20% growth in our commercial portfolio now that face-to-face activities have mostly resumed. The continued commercial success of our brand is a strategic imperative and at the core of maintaining a fundamentally strong balance sheet as well as working capital defined activities. Third, we will continue to advance development of our oncology pipeline and the development of TH1902, for the treatment of solid metastatic and refractory cancers. In tandem to this R&D effort, we are exploring out-licensing development for TH1902in Greater China. In addition to partnership with other pharma and biotech companies who are interested in our peptide as a carrier to target cancer cells through SORT1 receptors. Lastly, we will continue to advance our Phase III NASH program. Partnering discussions around NASH carried over from 2021 eso continuing, while we seek nondiluted financing options for the program. Having filed an amended protocol with the FDA, we are moving the program forward, which will carry a significantly derisk development profile by assessing the efficacy of tesamorelin on a much smaller subset of patients. I would like to reiterate that we believe these driving forces will allow the companies to be even more competitive in 2022. And unlike a majority of early-stage biopharmaceutical companies are technologies commercial business vastly differentiates ourselves as we continue to work on our development pipeline of late and early-stage assets spread across several indications. And with this, thank you, everyone, for joining our fiscal review of the period. We look forward to the next set of quarterly financial and milestone updates as our story progresses. Have a great day, everyone.

This concludes today's conference call. Thank you for participating, and you may now disconnect.