Theratechnologies Inc

TSX:TH

Earnings Call Transcript 2021-Q2

[Operator]

Good morning, ladies and gentlemen, and thank you for standing by. Welcome to the Theratechnologies conference call. [Operator Instructions] I would like to remind everyone that this conference call is being recorded today, July 15 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.

[Denis Boucher]

Thank you very much. Mr. Paul Lévesque, 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. A Q&A period will follow their presentation. Before Paul begins his remarks, I've been asked by Theratechnologies to read the following message regarding the 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, levels 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 sections of its management's discussion and analysis issued this morning available at www.sedar.com, and on EDGAR at www.sec.gov. Forward-looking statements represent Theratechnologies' expectations as of July 15, 2021. Except as may be required by securities laws, Theratechnologies does not undertake any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise. I would now like to turn the conference over to Paul.

[Paul Lévesque, President, CEO & Director]

Thank you, Denis. Good morning, everyone, and thank you for being with us today. Much has happened at Theratechnologies over the last 6 months as we continue to integrate step-wise changes that are intended to best optimize our business and position the company for long-term growth. An interesting aspect of our story that is not always understood, however, is that we have 1 foot in a clearly established revenue-generating commercial business with potential for upside. And another foot in an extremely promising pipeline in early-stage oncology, late-stage NASH development and life cycle management for our commercial portfolio. We firmly believe that the Phase I program evaluating our lead peptide-drug conjugate, TH1902, for treating sortilin-expressing cancers. And our Phase III development program evaluating tesamorelin for the treatment of NASH, both hold true promise to benefit patient communities in areas of unmet medical need as well as our stakeholders as we continue to strengthen our foundation for growth. As we announced today, we have completed our discussions with the FDA and EMA regarding the Phase III NASH program, and have a finalized Phase III clinical trial design and are now in a position to finalize the protocol. As we review the additional resources that are now required to conduct a Phase III clinical trial in NASH, we decided that it was in the best interest of the company and our stakeholders to evaluate opportunities that will allow us to more effectively execute this program, including initiating a search for a potential partner for late-stage development. While this will alter the planned timing of the Phase III clinical trial initiation, which was previously expected to begin in Q3 of calendar year 2021, by seeking and securing a partner, we may potentially add additional resources and capabilities. That will be of great value as we advance this exciting program towards a potential approval. We have already kicked off this initiative and retained the services of an external U.S.-based biopharma advisory firm to assist in identifying a potential partner. In many ways, this may sound like a shift from our existing strategy. However, this could not be further from the truth. In prudently shaping the future of Theratechnologies, we believe that we are keeping to our strategy and our promise to best serve patients and unlock shareholders value via a two-pronged approach: innovation and growth through our commercial business and promising pipeline programs. What is most promising about our current NASH position is the fact that we have built a ready-to-proceed Phase III clinical trial design, providing a very competitive program for a future partner. In particular, tesamorelin has demonstrated a strong and well-established track record of safety and efficacy over 10 years of product data in HIV-associated lipodystrophy. We have a strong intellectual property position that was further strengthened by newly issued patents for the treatment of liver disease and extends through 2040. We've collected extensive data from investigator-initiated studies in the hard-to-treat HIV NASH patient population that showed tesamorelin's unique mechanism of action that addresses the underlying cause of liver disease. With its new potential F8 formulation and multi-dose pen injector, to someone could have the opportunity to provide health care providers and patients suffering from NASH and HIV-related NASH, a new treatment option that may greatly improve adherence of tesamorelin and the treatment of this debilitating disease. And more importantly, we have received clarity from the U.S. and EU regulators and have finalized a comprehensive Phase III NASH trial design. In terms of regulatory discussions, the finalized Phase III trial design is planned for a multicenter, randomized, double-blind, placebo-controlled, 1:1 2-part study, designed to evaluate the safety and efficacy of tesamorelin in liver biopsy confirmed patients with NAS score of at least 4 in Stage 2 or 3 fibrosis. The clinical trial will also use a futility analysis that would be conducted after the first approximately 400 patients have completed 18 months of treatment and have received a second liver biopsy. This will allow us to see if an early treatment effect with tesamorelin has been observed to determine if the study should proceed as planned. We will be in a position to file an sBLA after approximately 1,100 patients, including 75 to 100 people living with HIV have completed 18 months of treatment and have received the second liver biopsy. Following potential approval, an additional 1,800 patients are expected to be enrolled to continue measuring clinical outcomes over a period of 5 years. As I said earlier, and will reiterate again, with the feedback from the U.S. and EU regulators, we have built a launch-ready Phase III development path forward. We believe that we are creating a stronger position to unlock the intrinsic value of our NASH pipeline asset by evaluating opportunities, including identifying a potential partner to bring this ambitious program through development and toward approval. This strategy will also allow us to continue to invest and further strengthen our commercial business and advance our promising SORT1+ Technology through clinical development as quickly as possible. Turning to our oncology pipeline. We continue to be very excited about the SORT1+ Technology in sortilin-expressing cancers and our recent discoveries garnered from preclinical work continued to confirm this opportunity. As I've said before, we believe that we have developed a targeted peptide drug conjugate that can potentially transform the way cancer is treated. Just recently, we reported preclinical in vivo findings of the anti-metastatic effect and tolerability of TH1902, further supporting TH1902's prospects, has a promising cancer-killing platform technology in sortilin-expressing cancers. These results demonstrate that TH1902 has better anti-metastatic activity. When compared to docetaxel alone, when administered at equal concentrations in the lung metastasis cancer model expressing the SORT1 receptor. It is well known that the survival rate for metastatic cancer is extremely low, and that SORT1 receptor expression increases as cancers progress. These new findings confirm that by targeting SORT1 receptor, TH1902 may potentially be effective in the treatment of metastasis. Most importantly, these preclinical findings, if confirm in humans, are promising signs that there may finally be a way to inhibit hard-to-treat cancers with a more effective and better-tolerated treatment and further broaden the cancer types that can potentially be treated with our SORT1+ Technology. Our SORT1+ Technology, including TH1902, is truly groundbreaking cancer treatment approach. Based on its mechanism of action and compared to cytotoxic drugs like docetaxel or doxorubicin, TH1902 allows for increases in intracellular concentration of the cytotoxic payload, offering a different PK profile while increasing the therapeutic window of the cytotoxic drug being conjugated. What is also extremely important when comparing TH1902 to an equimolar dose concentration of a cytotoxic drug like docetaxel alone is the absence of neutropenia. In our preclinical models, TH1902 has not shown to induce neutropenia, potentially allowing for sustained treatment, better tolerability and increased efficacy of TH1902. In terms of what to expect next for this program, based on the current progress of the trial, we plan to provide a safety and efficacy interim readout from the Phase I Part A of the study in Q4 of this calendar year. By year-end, we expect to have completed the Part A dose escalation study to establish the maximum-tolerated dose and inform the next step of the Phase I Part B basket trial which is expected to begin in early 2022. When we think about the potential runway for growth that is ahead of us, especially as we move our pipeline of potential medicines closer to approval, it is helpful and insightful to look back at how the biotech market has matured in the last decade. One thing of note that has stood out in the last few years is just how resilient the biotech industry has been. This is the case whether we're talking about driving innovation in healthcare care or talking about biotech's legitimacy as an investment class. Investors are looking to the sector for sources of new technology, innovation and approaches that will transform patients' life. At Theratechnologies, we have aligned our own way forward with these ideas in mind to keep up with change, drive innovation and evolve our business in anticipation of the strong growth that is to come. We've taken cues from the biotech industry historically and modeled best-in-class standards that place a strong emphasis on the need to address 3 key areas of importance. The first is building talent, second is handling complexity, and finally, improving commercial and development execution. On this first area of importance, we've placed a strong emphasis on near-term execution to best position ourselves for success. When you look at our recent investment, which extends our human capital, we have brought on experienced talent that are assuming critical leadership roles ensuring the successful execution of our strategic objectives. Recently, we welcomed André Dupras as a Vice President, who will lead our Human Resources function. Mr. Dupras brings more than 25 years of experience and was most recently Vice President of Human Resources at Clementia Pharmaceuticals. André will ensure that we are attracting the very best talent in the industry to help us grow the business, and he will ensure that we retain our current exceptional group of employees. In addition, Daniel Böck was brought on to lead our business and corporate development efforts. In this new creative role, Daniel will support the company's commercial and R&D strategic partnerships and alliances and assist in building out our relationships in the industry. Having strong leadership in these key positions gives us the ability to manage the complexity of operating a commercial and R&D business through the pandemic and beyond. We really look forward to their leadership and the contributions that they will bring to Theratechnologies in their respective field and roles. Turning to the second area of importance, handling complexity. I think nearly every company in every industry can point out to the COVID-19 pandemic as a prime example of how the organization has handled complexity during this time. For us, this has been centered around our commercial business. To that end, Symphony, one of the leading data providers for the industry, published data on office visits pertaining to HIV diagnosis during the pandemic. Looking at the data, the most significant takeaway related to our company was that through 2020 and into early 2021, overall genomic resistance testing was down 25% compared to previous periods. This is pretty significant that this data serves as a general proxy for our industry, and at a high level, is indicative of the pervasive challenges that we faced in the first half of this year. As many of you are aware, genomic testing is a prerequisite for initiating specialty HIV drug treatments like Trogarzo. During the second quarter, we continued to see this impact our top line results, in particular, Trogarzo as patient prerequisite testing continue to be hindered by the pandemic-created strains on health care facilities and physicians. The introduction of competitive pressures from newly launched therapies for the treatment of HIV may have also impacted the U.S. sales performance of Trogarzo during the quarter. In the EU, we continue to work toward obtaining an appropriate price and widespread reimbursement for Trogarzo in key European countries, and believe we have created a strong foundation for our medicines for when the pandemic-associated lockdown measures are fully lifted. Nonetheless, both in the U.S. and EU, we have continued to enhance our medical liaison teams and community outreach engagements as we look to build this area further as patients get ready to resume doctors' appointments again. Concurrently, we continue to prepare HCPs to be better informed and with better resources to prescribe our medicines, helping to ensure that patients adhere to prescribe treatment plans as they move through their patient journeys in the effort to improve their overall health. As I touched upon the third and final key area of importance, improving commercial and development execution, we continue to take the necessary proactive measures to build out our commercial business while being mindful that the short-term impact of COVID on the industry may continue in the U.S. and EU until we have fully exhibited the sustained challenges related to the pandemic. When we think about where we want to be with regards to sales following a full exit from the pandemic, we remain optimistic. We believe the sales, marketing and educational support infrastructure that we've built started to bear fruit on EGRIFTA SV sales during this quarter, which grew 12% over 2020. We are encouraged by the incremental gains in EGRIFTA SV sales in the first half of the year and believe that this is indicative of our patient activation efforts and digital strategy to support patients to initiate our therapy. These continued efforts around our HIV business are intended to be catalysts for a steady and incremental ramp-up in revenues going forward, and will also serve to reduce execution risk all the way through to the commercial stages of our pipeline candidates. We are firmly grounded in these near and long-term initiatives. And we are executing on our strategic operating plans accordingly while efficiently deploying capital and managing operating expenses. Looking at the overall business, I believe we have made valuable progress in 2021 thus far. And I can say with true conviction that we have executed against our strategy as reflected in a better, stronger organization with a talent pool that is aligning with our growth trajectory and ambition. With this, I would like to turn the call over to Philippe now to discuss the second quarter results. Philippe, please go ahead.

[Philippe Dubuc, Senior VP & CFO]

Thanks, Paul, and good morning, everyone. Consolidated revenues for the second quarter of fiscal 2021 were $17.8 million, an increase of 4% over Q2 2020, mostly due to an increase in EGRIFTA SV sales and hampered by lower sales of Trogarzo. Net sales of EGRIFTA SV were $10.3 million, up 12% from the same period last year when we recorded sales of $9.3 million. Unit sales of EGRIFTA were relatively stable compared to last year, but net sales were better due to a higher net selling price and lower rebates to public payers, given the switch from EGRIFTA SV from the old version of EGRIFTA, which carried higher percentage discounts than EGRIFTA SV. Trogarzo revenues were down 6% year-over-year as a result of lower sales to specialty pharmacies, the effect of the ongoing COVID-19 pandemic resulting in difficulty for patients to visit health care facilities to meet with physicians and obtain their intravenous infusion, competitive pressures and slightly higher rebates as well. These factors were partially offset by a higher selling price. And recall that in Q2 2020, at the beginning of the pandemic, net sales of Trogarzo were positively impacted by unusually large orders by pharmacies, which have since stabilized. In the EU, while the COVID situation is still problematic mostly with respect to patients getting onboarded on therapy, our team in Europe continues to identify patients. We believe that the latter part of the year may provide incremental gains. Pricing discussions are progressing in the EU and reception has been positive. With this in mind, we have laid the groundwork to growing revenues of the Theratechnologies franchise and expect to see our efforts bear fruit from these strategic initiatives. Cost of sales in Q2 2021 was down to $5.9 million compared to $7.3 million for the same quarter last year. The decrease is mostly due to higher gross margins on EGRIFTA SV compared to EGRIFTA as well as a lower transfer price for Trogarzo given the achievement of a predetermined amount of net sales in Q3 of last year. R&D expenses amounted to $6.4 million in Q2 2021 compared to $3.6 million for the same quarter last year. This increase is largely due to higher spending in oncology with the initiation of our Phase I trial, increased activity related to our NASH program including on the new F8 formulation, increased spending in medical and patient education as well as higher medical affairs initiatives in Europe. For the 3-month period ended May 31, 2021, selling expenses were on par with Q2 2020 and were stable at $6.9 million. G&A expenses amounted to $3.9 million in Q2, up slightly from $3.7 million in Q2 2020. The increase in G&A expenses is largely due to increased overall business activity in 2021 compared to 2020. This increase is partly offset by onetime items incurred in 2020 as a result of the retirement of the company's previous CEO. In Q2 2021, we recorded $1 million in net finance costs compared to $1.4 million in Q2 2020. As previously stated, finance costs comprised of interest on convertible notes as well as accretion expense. Net finance costs in 2021 were reduced by foreign exchange gains of $378,000. For the second quarter of 2021, we recorded a negative EBITDA of $2.6 million compared to negative $1.5 million last year. This difference is mainly due to a higher net loss during the quarter. For the second quarter of 2021, our operations, including variations in working capital, used approximately $700,000 of cash, which explains why our cash balance has remained virtually identical to that of February 28, 2021, at approximately $57 million. I will now turn the call back to Paul for some closing remarks.

[Paul Lévesque, President, CEO & Director]

Thank you, Philippe. Looking back at the first half of the year, we're pleased with the organization that we have become. Innovation that we are developing is really special and has the ability to greatly improve. And in many instances, transform patients' lives across areas of high unmet medical need. As we look to carry this momentum through the remainder of 2021, I am ever the more confident that we will improve our commercial business while advancing our research pipeline. In the short term, our priorities remain focused on delivering growth from our commercial portfolio, completing the dose escalation part of our oncology trial, and of course, exploring opportunities, including finding a potential partner to maximize the value of our Phase III NASH program. And with that, we will now open the call to take your questions. [Operator Instructions]

[Operator]

[Operator Instructions] Our first question comes from Andre Uddin with Research Capital.

[Andre Uddin, Managing Director of Healthcare Research]

In terms of your NASH potential partnership, which I think is actually a great idea, can you please describe your ideal partner? Will you look for them to fully fund the Phase III trial or will you look to codevelop it and then later co-promote it? And also with this potential partner, would you look to co-promote EGRIFTA for HIV?

[Paul Lévesque, President, CEO & Director]

Well, thank you, Andre, for the question, and I'm glad you feel that way. This is certainly a position of strength that we're facing at this time. We have an approved protocol in our lab. There are not too many companies that can actually, in such an area of unmet medical need, be in a position like this. When it comes down to the ideal partner, I think that it can take different forms. And it's kind of too early to actually take a look at all the possibilities that are ahead. But they're certainly the one that comes with co-development, co-promotion so co-commercialization down the road. Other companies may decide to actually that they want to invest, but they would want us to continue the development and maybe have a piece of the commercialization later on. So I think that we have already with our adviser, have done a mapping of the potential pharmaceutical companies, big companies, medium-sized, with an interest in NASH. And we know what these companies are. And I think that we'll see down the road what type of partnership we can sign with them. But one thing is for sure, nobody knows tesamorelin more than we do. So we need to actually keep investing, keep unfolding our plan, and we're fully committed to put that to life with a partner with other means that we're going to find in the upcoming months.

[Andre Uddin, Managing Director of Healthcare Research]

Okay. And just also on the business development front, are you looking to add any new commercial-stage products that you think would fit with your current sales force?

[Paul Lévesque, President, CEO & Director]

The answer is yes. We are on the lookout, and this is a strategy that makes a lot of sense for us because we've got 2 products in the bag in the U.S. We have only 1 product in Europe. So we'll take a look at how we can identify what I call a drug companion that could actually synergize with the portfolio that we have, and that would increase the critical mass of assets. That would make sense for the target of doctors that we are calling on at this time. So we will actually do some work. We've already started. Again, the pandemic made some of that more complicated, but we will look into it. And we'll see if we find that sweet spot again with the ideal companion.

[Andre Uddin, Managing Director of Healthcare Research]

Okay. And just also, one last question here. I just saw that there is an EGRIFTA Phase II trial being run with 100 HIV patients with MCI or mild cognitive impairment. Can you discuss how this trial came about? And when the results for that trial are expected roughly, if you know?

[Paul Lévesque, President, CEO & Director]

Christian, do you want to handle, please?

[Christian Marsolais, Senior VP & Chief Medical Officer]

Absolutely. Yes, Andre. Thank you for the question. I don't know, Andre, if you remember, but we have done first, a number of years ago, a study in non-HIV in the general population in mild cognitively impaired patients with [ Dr. Orbetello ], and we have shown positive results. Following that study, there are also studies showing, in HIV, that an increased waist circumference is also associated with mild cognitive impairment and Dr. Fred Schaerf and Ron Ellis have been working with us to start that trial. And that trial has been ongoing for a number -- probably about 2 years now. We hope that the recruitment will be completed in 2022, and it is a 6-month study, then we should potentially see results in 2023. And it's a good rationale for -- based on the preceding studies that were done with EGRIFTA.

[Andre Uddin, Managing Director of Healthcare Research]

So all the patients in that trial were HIV?

[Christian Marsolais, Senior VP & Chief Medical Officer]

All the patients in that trial are HIV. It is linked to a study that Dr. Ron Ellis -- a pedomanological study that Dr. Ron Ellis has done in the past showing the link between increased waist circumference,which is increased visceral adipose tissue or ectopic fat and decrease in cognition.

[Operator]

Our next question comes from Edward Nash with Canaccord Genuity.

[Edward Hamilton Nash, Analyst]

So I wanted to understand, so I know that we just got the protocol now approved, I guess, officially. But we've known since roughly almost a year ago now that you were not going to be allowed -- or the agency was not going to be receptive to you looking at only NASH patients that were the head HIV. So I'm just trying to understand now that you're deciding to partner. I mean, your cash balance is what it is, which is going to drive the decision. But we already kind of knew what your cash balance was then, too. So just what's changed between -- since last year and now with regards to your decision to look for a partner for the Phase III NASH.

[Paul Lévesque, President, CEO & Director]

Well, thank you very much. Listen, what has changed is that the cohort size now has increased. And through the negotiation with the agencies, they've asked for additional monitoring to be done. And the monitoring is something that we had partially anticipated, but that's the type of thing that comes out when you negotiate with the agencies. All of that is increasing costs just about 25%. 25% over the period of time of that trial is significant. And I think that this is the sweet spot now that we are facing because we have a protocol that is ready to proceed. And I think that if there is a moment where we can, with credibility attract and discuss with a potential partner, it is now. Having done that 6 months ago, we were in the midst of interacting with the agencies at that time. So first thing that they would have asked is tell me more. And I think that we would like to see if the partner wants to actually be part of the beginning of that trial. So this is the moment that we're in. It's the ideal time. I think that if the partner would like to team up, take a look at the protocol, it's not too late. We can do different things if needed. But the protocol is ready to proceed, and we have all the confidence in the world that this protocol will tip this to an approval. So going back to your question, I think that what has changed is the additional cost, the complexity of this trial. And I think it's prudent and probably a good thing that we explore the opportunity of having a partner in at this time. Thank you for your question.

[Edward Hamilton Nash, Analyst]

No. I think that was helpful. And I guess the second part to that is just with regards to modeling this, I mean, obviously, this could go -- this can take many different forms, as you mentioned. But of the 6 Phase III -- 6 companies running Phase IIIs right now for NASH. They're all in this alone. And I just wanted to know on that side, have you already guys -- have you already had people having access the data on a confidential basis showing interest? Or is this kind of an effort that now that you have a BD guy on board, is this something that's just now starting new from scratch?

[Paul Lévesque, President, CEO & Director]

Well, I'm not going to get into the detail, but the outreach has started and the discussions are ongoing. And I cannot reveal where we are. But this is serious stuff. There is a fair amount of interest at this time, and we're going to go through the process step-wise, and we'll let you know once we have more to say.

[Edward Hamilton Nash, Analyst]

Got it. That's great. And then my last question is just with regard to the F8 formulation, the pen formulation, can you remind us again when you expect to have that available for -- to replace the EGRIFTA SV?

[Paul Lévesque, President, CEO & Director]

Christian, do you want to...

[Christian Marsolais, Senior VP & Chief Medical Officer]

Yes. Absolutely. The plan is to submit the dossier in the first quarter of 2022, then it should be available. It's a 5-month review, then it should be available towards the third fourth quarter of 2022. And the main reason is that we need to gather more stability like the F8 is relatively new, and we are gathering stability data for the share slide.

[Operator]

Our next question comes from Endri Leno with National Bank.

[Endri Leno, Associate]

I'll pick up again with the NASH, and I have a couple more after that. But a question I had is that what possibility do you guys foresee that a partner may ask for a general NASH data prior to an agreement?

[Paul Lévesque, President, CEO & Director]

Would you mind repeating your question because the line wasn't all that clear and we couldn't hear you very well.

[Endri Leno, Associate]

Sure. Yes. So what is the possibility that you guys foresee that a partner may ask for a general NASH data prior to an agreement?

[Paul Lévesque, President, CEO & Director]

Well, I mean this is an interesting question, but we've got a ready-to-proceed protocol at this time that has been negotiated. So I think that the 2 agencies were pleased with what we actually presented in front of them. And quite frankly, over the last 12 months, we have broadened our support for tesamorelin in the general population. You would remember that to get to this point, it's been a pretty long journey. We started with having interest in NASH in the HIV population. And based with -- based on our early interaction with the agencies, we actually were told that we should actually think about the general population. And we actually look forward to that, and we ended up broadening our support among the experts in the industry. And I think now we're all set to go. Christian, do you want to add anything?

[Christian Marsolais, Senior VP & Chief Medical Officer]

Yes. Maybe, Endri, just to -- I'll go back on the scientific side and the mechanism of action. There is a clear association between decreased release in G8 and increased visceral adipose tissue, and increase in liver fat in both patient population, non-HIV and HIV. And that's really the mechanism of action that we're targeting. The other thing that we have done so far, we have done a study with EGRIFTA in both HIV and non-HIV. In both patient population, we have shown a good similar decrease in visceral adipose tissue. And in the HIV population, we have shown a decrease in liver fat of about 40%, which we think it is the same because there's a good correlation between the decrease in visceral adipose tissue and liver fat. Therefore, in the general population, it should be similar. And all of our experts that we work -- independent experts that we worked with told us that this is the best way and the best approach to go then. We're very confident with the data that we have, and it was supported by the regulatory agencies that we can go ahead and move in the general population.

[Endri Leno, Associate]

Okay. Great. Actually one more, perhaps for Christian. If you can please refresh us on the current endpoint as per the last protocol versus your prior expectations and the results already obtained in Trogarzo at NASH, please?

[Christian Marsolais, Senior VP & Chief Medical Officer]

Yes. For -- you need for the EGRIFTA NASH in terms of the endpoint for the Phase III trial?

[Endri Leno, Associate]

Yes, please.

[Christian Marsolais, Senior VP & Chief Medical Officer]

Yes. What we're looking at, at the moment is a normalization in the NASH. 4 patients will be -- will have an NAS score of 4 and more at the entry and fibrosis of 2 or 3. We're looking at the normalization of NASH in 10% of the patient. This is a primary endpoint without a negative impact on fibrosis. But fibrosis will also be assessed, and fibrosis will be a secondary endpoint. And based on the data and recent publication from Dr. Loomba, we know that the decrease of 30% in liver fat is associated with normalization of NASH, and it's also associated with decrease of fibrosis. Then we're quite confident in those 2 endpoints for the Phase III program.

[Endri Leno, Associate]

Got it. Great. My other question is more to do with the sales in the quarter for Trogarzo. I don't know if you guys are able to provide a bit of a breakdown of the 6% decline. And how much of that was due to lower volume, how much was due to competition and then rebates?

[Paul Lévesque, President, CEO & Director]

Philippe, do you have a few -- I think you had a few statements in your speech. Can you go ahead?

[Philippe Dubuc, Senior VP & CFO]

Sure. Sure. So Endri, it's really a mix of everything. So we are -- we did see lower unit volumes. Trogarzo has been more affected by the pandemic, especially if -- when immunocompromised patients are told to stay at home. So that was affected -- it affected the unit sales, it affected new prescriptions as well. Remember, last year, there was a huge spike in orders from pharmacies at the beginning of the pandemic. So that kind of normalled out a little bit between -- during that quarter last year. But still inventory levels at the end of last quarter were kind of high. So it's really a mix of everything that resulted in this minus 6% in sales.

[Endri Leno, Associate]

Okay. No, great. But as we look more into -- I mean specially volumes, like what are you seeing or what do you expect to see over the next few quarters? I mean given that most of the things were pretty much open in the U.S. the last quarter and as we see new cases starting to ramp up a little bit. I mean, should we expect sales or volumes at least flattish or a bit below or a bit up, trending upwards?

[Paul Lévesque, President, CEO & Director]

Well, thank you for the questions. We are into this for growth. So we're committed to Trogarzo. We're committed to EGRIFTA. The good news is now the field force are up and running. Again, face-to-face calls are increasing. And obviously, that's the best way we can get our messages out to our physicians and patients somehow. So we are optimistic that we're going to be firming up the performance of both assets. Things have slowed down in Europe due to the pandemic and the lockdown. Now we will resume our pricing and negotiation. What is important to me, quite frankly, is that this drug, Trogarzo, be relevant to patients and HCPs. And we're going to work hard because we know that they need alternatives to treat their patients. So we foresee growth with both assets in the upcoming months, and we're going to work hard to make that happen. And I think that I would leave it at that for now.

[Endri Leno, Associate]

Okay. Great. And one last one for me. If you guys can talk a little bit in terms of costs, hyper costs, how do you see them over the next 2, 4 quarters?

[Paul Lévesque, President, CEO & Director]

Philippe, do you want to take that?

[Philippe Dubuc, Senior VP & CFO]

Yes. Well, until we start the NASH trial, I think you can pretty much assume that on the SG&A front, and even on the R&D front, it should be relatively stable. So until we do start the NASH trial, this quarter is probably a good proxy.

[Paul Lévesque, President, CEO & Director]

And let me add one thing on your question again. I'd like just to say that there's new dynamics going on in HIV as new competitors are launching. But at the same time, the market is moving to long-acting. We have a long-acting compound with Trogarzo. So we're going to make sure that, that gets to our physicians and that they see the benefits of prescribing Trogarzo in the mix of drugs they need to take or to prescribe to control patients.

[Operator]

[Operator Instructions]

[Denis Boucher]

As it seems, as we do not have additional questions from analysts, we will now turn to questions submitted by other participants in writing. The first question that we have is, if there is a timeframe that you expect to finalize a partnership in NASH?

[Paul Lévesque, President, CEO & Director]

Well, as we said today, I think it should be clear that we are going to look at all the options that we have. As I said, we are in a position of strength. It's very important that we take a little bit of time now and somehow even slow down to better accelerate in a few months. This is a long journey. So if we can find a partner that will bring resources but also capabilities, I think that the slowing down aspect of this will be forgotten very, very fast. So what is more important for us, at this time, it's really to find the ideal partner. And I think that time line will take care of itself along the way.

[Denis Boucher]

Thank you, Paul. Another question here. If we don't find a partner, would we decide to proceed on our own or just give up on it?

[Paul Lévesque, President, CEO & Director]

Well, we're certainly not going to give up. We have a protocol that we worked absolutely hard to get to where it is now, and that can actually make us enter the market first, second or third and be extremely relevant in an area of unmet medical need. So we're just, as I said, at this time, it's premature to actually go over and speculate over what would happen. But the partnership is on the table at this time. We've got an advisory company that is helping out. The process has started, the outreach is on. And we'll actually meet these organizations, unveil the data, get them to see what we have seen, get them to actually interact with the advisers and KOLs that are supporting this. And I'm very confident that they're going to want to actually be part of it.

[Denis Boucher]

Thank you. [Operator Instructions] Now on the oncology platform. Given the time line presented during the last webcast, can it be assumed that we are in the therapeutic-dosage level of docetaxel?

[Paul Lévesque, President, CEO & Director]

Christian, do you want to provide an update?

[Christian Marsolais, Senior VP & Chief Medical Officer]

Yes. Absolutely. I won't go into specifics of the trial. As you know, the -- we have to manage the study very confidentially to some extent, and make sure that if we announce something that everything will be validated. But at the moment, the recruitment is going very well. We're recruiting patients and dose escalating at a rate of 3 to 4 weeks. We could do it every 3 weeks. But by the time that we recruit the following patient ensuring that everything is done, and we have the appropriate data from the prior cycle, then it's going -- the increase is every 3 to 4 weeks. And we started the first patient, as you know, on March 23. And the study is proceeding well. And we also now have increased the number of sites. We started with per site of Dr. Cheryl Ginsberg, MD Anderson, has been open for a few weeks, and we now have opened 2 additional sites for recruitment.

[Denis Boucher]

Thank you, Christian. We have another question regarding the oncology platform, regarding the number of patients that have been dosed so far and if all 4 centers have enrolled patients.

[Christian Marsolais, Senior VP & Chief Medical Officer]

At the moment, all 4 centers are active in screening patients. At the moment, we have 2 sites that recruited patients. But in the coming months, the other sites will also add patients to this program.

[Denis Boucher]

Thank you very much. Regarding our HIV business, with the focus increasingly on oncology, what's to think of the HIV business?

[Paul Lévesque, President, CEO & Director]

Well, the HIV business is that we've got a commercial lane to our business, and we're generating revenue. So we shouldn't be ashamed of generating revenue. It's a good thing. And what is more important to me is even the fact that we are building capabilities for the future. We have an organization in Europe. We have an organization in the U.S. We're calling on doctors. We've got MSLs on the ground. We're doing what midsized, large-sized pharma are doing, and that's going to be handy in the future. Especially as the NASH program is going to unfold, I think there was going to be a long prelaunch phase associated to that, having people on the ground, capabilities. Having people who know inside out, what a [ great phase ] is all about will be a great asset for ourselves and also for our potential partner. So the HIV business for now is important. It's generating revenues, and it allows us to build capabilities for the future.

[Denis Boucher]

Thank you. Going back to the oncology platform. In terms of efficacy, are there any expectations coming out of our Phase I?

[Paul Lévesque, President, CEO & Director]

Christian?

[Christian Marsolais, Senior VP & Chief Medical Officer]

Yes. Maybe let me start with the objective of this Phase I trial, which is really to determine what will be the maximum rate of dose of the drug, which will be the dose that will be used in the Phase II. However, as you know, that study is done in cancer patients that are advanced and that are resistance to prior treatment. And it is possible that we observe some efficacy. And this is why we think based on the number of cycle and the length of time it takes to confirm if there's a response because if we see an impact on the tumor shrinkage, we still need to wait for 3 months before we can confirm the response that we would be in a position to revoke some information in the fourth quarter of 2021.

[Denis Boucher]

That's great. Thank you, Christian. One additional question. In terms of safety, is there -- do we expect to see neutropenia at scheduled doses?

[Christian Marsolais, Senior VP & Chief Medical Officer]

Once again, this is the same thing. It's -- I cannot talk about the results or the dose that we're up exactly at the moment. However, based on the animal data that we have seen, and based on the test program that we have conducted, we certainly do think that we won't see neutropenia at equimolar concentration of docetaxel that we will be able to dose escalate higher than the dose of docetaxel presently used to treat cancer patients. And once again, we think that this data will firm up, and we'll probably be able to announce something in the fourth quarter of 2021.

[Denis Boucher]

Wonderful. Thank you, Christian. [Operator Instructions] And I will give a few seconds for additional questions to come in.There doesn't seem to be more questions coming in this morning. So at this time, we will conclude this morning's earnings conference call. I would like to thank everyone for being on the call this morning. And on behalf of everyone here at Theratechnologies, I wish you a very pleasant day. Thank you.

[Operator]

Well, ladies and gentlemen, this does conclude today's presentation. You may now disconnect, and have a wonderful day.