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Theratechnologies Inc. (NASDAQ:THTX)
Q1 2020 Earnings Call
Apr 14, 2020, 8:30 a.m. ET

Contents:

  • Prepared Remarks
  • Questions and Answers
  • Call Participants

Prepared Remarks:

Operator

Good morning, ladies and gentlemen, and thank you for standing by. Welcome to the Theratechnologies Conference Call. [Operator Instructions] I'd like to remind everyone that this conference call is being recorded today, April 14, 2020, at 8:30 a.m. Eastern Time.

I'd now like to turn the call over to Denis Boucher, Vice President of Communications and Corporate Affairs. Mr. Boucher, please go ahead.

Denis Boucher -- Vice President, Communications and Corporate Affairs

Well, thank you, and welcome. Paul Levesque, President and Chief Executive Officer of Theratechnologies; as well as Mr. Philippe Dubuc, Senior Vice President and Chief Financial Officer, will be the speakers 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 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, 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 section of its press release issued this morning and to the Risk Factors section of its Annual Information Form dated February 24, 2020, available at www.sedar.com and on EDGAR at www.sec.gov as an exhibit to our report on Form 40-F dated February 25, 2020 on the Theratechnologies' public filings. Forward-looking statements represent Theratechnologies' expectations as of April 14, 2020. 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.

Paul Levesque -- President and Chief Executive Officer

Thank you, Denis. Good morning, everyone, and thank you for being with us today. I was very much looking forward to my first opportunity to introduce myself and to make acquaintance with the analysts and the many investors on the line today. Of course, I would have preferred that my first public appearance as President and CEO of Theratechnologies happened under better and more normal circumstances.

Some of you may wonder why I decided to leave Pfizer and join a small Quebec-based pharmaceutical company. Let me answer this question by giving you a bit of background as to where I come from and how I see opportunities unfolding at Theratechnologies. I grew up in Quebec city, where I completed my undergraduate degree in biochemistry. I then obtained my postgraduate degree in Management from McGill University. I pursued this academic training given my attractions to science and business. Not surprisingly, I turned to the pharma industry. My first job in pharma was with Upjohn, where I stayed for the first six and a half years of my career. I then joined Pfizer in 1992, where I spend the next 28 years. Interestingly, I've been positioned outside of Quebec, namely the United States, Europe and Asia for half of those 35 years in the industry. My last assignment at Pfizer as Global President of the Rare Disease business unit was particularly exciting, challenging and rewarding. I've learned a lot, including to bring to patients unique therapies in areas of high unmet medical needs. This expertise is what I want to put to contribution at Theratechnologies as I foresee great opportunities ahead, where the same skill sets and approach will allow us to win in the marketplace.

Theratechnologies possesses all the key elements of a global pharma with end-to-end capabilities and a promising future. It has commercialized assets in areas of unmet medical needs. Trogarzo was approved under priority review, was designated as breakthrough and features a unique mode of action, preventing the HIV virus to enter into the cells. Combined to its safety profile, Trogarzo is an dispensable tool for HCPs to control the viral load in many patients. Furthermore, Trogarzo benefits from widespread reimbursement.

As for EGRIFTA, it is the only product approved to treat HIV-associated lipodystrophy, a metabolic condition, which has serious health consequences. The recently launched SV formulation offers a smaller injection volume, comes in a single vial and can be kept at room temperature. The table is set, I believe, for increased demand.

Now, let's talk about our pipeline for a moment. Theratechnologies has a promising pipeline in NASH and an oncology platform, which hold great potential. EGRIFTA has been on the market for eight years, and its safety profile is well established. The thinking is that preventing and decreasing the accumulation of patent deliver can prevent, stop or reverse the horrible inflammation cascade and health consequences associated to NASH. Based on the feedback received from the FDA and EMA, we are currently contemplating different trial designs to maximize the opportunities. Last, but not least, the animal model related to our oncology platform is also showing great potential and will be soon ready to enter first-in-human development.

In summary, not only do we have a significant potential with the assets already approved in the US and EU, but the future is exciting and full of promise. This is why I decided to join Theratechnologies. I feel absolutely privileged to have been called upon to take the helm of this Company at this time when it is facing such an exciting inflection point. The Company has existed for over 20 years, and top-notch individuals will help me carry the torch to success.

This said, let's talk about my 60- or 90-day plan. During my career, I must have transitioned to new roles over 15 times. Every time, I go at it in a very simple but systematic way. This time will be no different as I will start by assessing capabilities within the Company. I will then review our business model and pin down the levers of success and the investment required to fully activate them. Once everyone is onboard with what the right plan is, then we will focus on the execution. And I will hold people accountable for doing what needs to be done. As previously said, this is a simple way to dive and assess the situation, but it is the best way to share objectives and get colleagues to work as a cohesive team.

Now, the current situation with COVID-19 is everything but normal. And therefore, it will be imperative that we find an effective way to keep interacting with HCPs and patient association. From an operational perspective, the team was ready to face the crisis. We had a plan in place to ensure that patients will continue to have access to our products. The plan was rapidly implemented. We managed to take care of patients while protecting the health and safety of our employees and avoid a catastrophic scenario, where key employees could have been contaminated and become sick, thus, threatening business continuity. We had the technology required to have everyone at our head offices in Montreal and Dublin fully productive while working from home.

Measures taken have been effective so far. Furthermore, our supply chain remains unaffected and inventory of our products is sufficient to meet market demand for the next 12 months in all territories where they are commercialized. Ever since the crisis struck, we have worked to scale up our virtual capabilities. As you know, our sales representatives can no longer have face-to-face meeting with physician. In light of this challenge, we quickly implemented measures to maintain interaction with physicians through virtual meetings and webinars.

Despite these times being challenging, I believe that there is an opportunity for us. Indeed, people living with HIV are among the most vulnerable to COVID-19. This is especially true if the patient's viral load is not well controlled and his or her immune system is compromised. Trogarzo has been on the market for 18 months and is proven to be safe and effective in patients for whom other existing treatments have failed to bring their viral load below detection level. In fact, its unique mode of action makes it an ideal add-on for uncontrolled patients. More than ever, these patients must be looked after and must receive the best care available to protect them from COVID-19 and to avoid the potential dire consequences of being infected by it. If anything, COVID-19 is a good lesson to all that we should -- that we shall not be lenient when it comes to patients with detectable and unstable viral loads. This message is not only clinically relevant, it is completely grounded in today's crisis. We will now use the best vehicles to bring this message to targeted healthcare professionals and patient associations in the current context. Our goal is to ensure that everyone currently treated with one of our products continues to be without interruption, and that patients who should be treated with one of our products receive it without undue delay.

At the end of the day, we must remind ourselves that this crisis is not going to last forever. As it unfolds my role and that of my team is to maintain the highest level of activity under the circumstances, while looking ahead and being ready when things start getting back to normal. Our future also rely on the development of our pipeline. As we reported on March 31, our research and development activities are still progressing. And thus far, the clinical research organization we work with are still active.

On the NASH front, we're pleased with the feedback we received from both the FDA and from EMA regarding the proposed clinical development programs for tesamorelin in the treatment of NASH in people living with HIV. We should start discussion with the two agencies fairly soon to find a common approach for the research protocol. As you know, we intend to use a new formulation of tesamorelin, also known as F8. A pilot study to assess the bioequivalence of this new formulation to the original version of tesamorelin was recently completed, which paved the way to a complete bioequivalent study, which should be soon initiated.

Compared to the recently launched EGRIFTA SV, this new formulation of tesamorelin can be reconstituted once a week and remain stable at room temperature after reconstitution. Furthermore, given its much smaller volume of injection, Theratechnologies is assessing a multi-dose auto-injector for the F8 formulation. The F8 formulation is patent-protected until 2033 in the US and until 2034 in major EU countries. Our oncology program is also moving forward, and we should be in a position to release new clinical data in the near future. So as you can see, we remain very busy despite different context. Over the coming days and weeks, we will continue to develop and implement new initiatives aimed at reducing the impact of the crisis and to give us an edge when we come out of it.

On that note, I will let now Philippe present our results for the first quarter, and I will come back after for a few closing remarks. Philippe?

Philippe Dubuc -- Senior Vice President and Chief Financial Officer

Thank you, Paul, and good morning, everyone. Before diving into our financial results for the first quarter, I would like to give a brief update on our European operations. I'm pleased to say that we received an initial Trogarzo shipment from WuXi in China at the beginning of March, and that testing and quality control for the release of this shipment is ongoing. We do not foresee any issues preventing the release of commercial product. As Europe is pretty much coming to a standstill, we are currently reevaluating the timing of our launch but we are confident that we'll be able to commercially launch Trogarzo before the end of this fiscal year as discussions with payers, which were highly encouraging, have slowed substantially in the past few weeks. We also have encouraging signs in the market as new patients are still coming into our early access programs, highlighting the level of interest and the need for the product in EU countries.

So we closed our first quarter a couple of weeks before a worldwide pandemic was declared by the World Health Organization. Our first quarter results were not affected by the pandemic, and we recorded consolidated revenues of $15.7 million, compared to $15.1 million for the same quarter last year. This represents a growth of 4.1%.

During the first quarter, Trogarzo net sales reached $7.2 million, compared to $6.1 million for the same quarter last year, representing an increase of 17.4%. Trogarzo sales growth was a result of increased efforts put behind marketing, medical education efforts and patient engagement, such as direct-to-consumer campaigns and increased social media presence.

As for our EGRIFTA franchise, sales were slightly down due to a longer-than-usual delay between the time the prescription is written and the time the patient receives the first treatment. This is due to the introduction of EGRIFTA SV and is quite normal in a transition period when some insurers might take more time than others to include new products on their formularies. We expect the situation to come back to normal during our current second quarter. For the first quarter of 2020, EGRIFTA sales reached $8.5 million, compared to $8.9 million for the same quarter last year.

Cost of sales in Q1 2020 reached $6.7 million, compared to $6 million for the same quarter last year. The increase is primarily due to higher sales of Trogarzo, which carry a higher cost of goods sold. Cost of sales also includes a $1.2 million charge in amortization, a figure which is stable from quarter-to-quarter.

R&D expenses increased to $3.4 million in Q1, compared to $2.5 million for the same quarter last year. The increase is largely due to the development of our oncology platform and various regulatory expenses related to tesamorelin.

For the three-month period ended February 29, 2020, selling expenses were up compared to the same quarter last year. For Q1 2020, they amounted to $6.4 million compared to $5.4 million for the same quarter last year. The increase in marketing activities in the United States and the development of our infrastructure in Europe explain the increase in selling expenses.

G&A expenses increased as planned to $2.6 million in the first quarter of 2020, compared to $1.5 million for the same quarter last year. The increase is mainly due to the overall growth of the business, the higher level of activity in Europe and the listing of our common shares on NASDAQ. In Q1 2020, finance costs were $1.3 million, compared to $1.1 million last year. Finance costs also include -- finance costs include interest on the senior convertible notes, as well as an accretion expense of $500,000 compared to $357,000 for the same quarter last year.

For the first quarter of 2020, we recorded a negative EBITDA of $1 million, compared to a positive adjusted EBITDA of $1.5 million in Q1 of last year, and we generated a loss of $4.5 million, or $0.06 per share, compared to a net loss of $1.2 million, or $0.02 per share in the same period last year.

During the three-month period, our operations used $994,000 of cash, while changes in operating assets consumed $3.8 million, mostly as a result of a decrease in accounts payable. Our financial position remains strong with close to $35 million in cash and bonds at the end of the first quarter.

As previously announced, given the current situation with the worldwide pandemic, we have pulled our revenue guidance for the current fiscal year until further notice.

I will now turn the call back over to Paul for his closing remarks.

Paul Levesque -- President and Chief Executive Officer

Thank you, Philippe. When I decided to join Theratechnologies, the pandemic was not even on the radar. My decision was based on the fact that Theratechnologies has great assets, both commercial and in development. The pandemic has not changed any of that. Our assets and potential are there for the long-term, but the pandemic is a short-term event. We've managed to keep our business moving forward and to maintain our supply chain intact. Given our inventory levels, I'm not concerned by product shortage for existing and new patients.

As nobody knows how long this will last, my focus will be to monitor the situation closely and to align our expenses based on the evolution of our revenues in the coming months. At the same time, the team will try to turn this difficult situation into an opportunity. Now more than ever, people living with an uncontrolled or detectable viral load need to be looked after. We will continue to implement new initiatives to reach healthcare practitioners and patients virtually to communicate this crucial message.

We have been able to turn on the dime and to adjust very quickly to the reality that has changed our world. We were among the first in the pharma industry to implement contingency measures to minimize the impact on our business and to preserve the health and safety of our staff and our customers. I want to thank the entire team for what they have done so far and for their continued support as we work together to make it through the crisis. I have no doubt that we will be coming out of this stronger.

I want to thank you all for being on the call today, and we will now take questions from financial analysts. Thank you.

Questions and Answers:

Operator

[Operator Instructions] And our first question comes from the line of Brian Abrahams. Go ahead, please. Your line is open.

Brian Abrahams -- RBC Capital Markets -- Analyst

Hi. Thanks so much for taking my questions. It's Brian Abrahams from RBC Capital Markets here. I guess, starting off on Trogarzo, just wondering if you could maybe talk a little bit more specifically about how the administration of Trogarzo is being accomplished during this COVID-19 crisis. What kind of impact you're seeing of the pandemic on new patient starts and compliance for existing patients? And whether there might be ways to further increase the rate of -- which patients are getting home infusions? What are the barriers there? Is that something you could potentially accelerate in this environment? And then I have a follow-up. Thanks.

Paul Levesque -- President and Chief Executive Officer

Thank you, Brian, for the question. I'll turn to Jovan, our Head of Commercial, to answer the question with hands on experience. Jovan?

Jovan Antunovic -- Senior Vice President and Chief Commercial Officer

Yeah. Thank you, Paul, and thank you, Brian, for the question. So, as it relates to the infusion process, Brian, we have not seen any impact as of today. All the locations that are infusing are considered essential services. And for the home infusion situation, we have people that are certified and take necessary precautions.

As it relates to the slowdown, I think it's probably fair to say that there has been a slowdown across the industry on multiple therapeutic areas, and it varies from company to company. And we have seen a little bit of a slowdown, but we are still very happy that we are continuing to get enrollments for both Trogarzo and EGRIFTA during this past -- these past few weeks.

Brian Abrahams -- RBC Capital Markets -- Analyst

Got it. That's really helpful. And then, I guess, just my other question would be sort of bigger picture. And first, welcome to Paul. And Paul, just wondering if you could maybe speak to -- and obviously, I know it's early days, but your thoughts in terms of any potential changes in overall strategy or expansion of focus for the Company perhaps into some of the areas like rare diseases, where you have particular levels of experience that you can leverage as well. And I'll hop back in the queue. Thanks.

Paul Levesque -- President and Chief Executive Officer

Thank you. Thank you for the question. Well, as I said in my opening remarks, I think that I will be going at it in a very systematic way. So I just want to review the capabilities of this organization. I've been on Board now for the last six days. So, obviously, I still have a bit of deep dive to do. But so far, so good. I'm very, very happy with the colleagues and their knowledge and the fact that they've been carrying the load for so long. This Company has had success and is well anchored.

Now, it all starts with having products that actually offer solutions to unmet medical needs. So I need to review the quality of our message, and what is the plan that we have to make sure that we take advantage of the opportunities. And I truly believe that it's the same type of work that I was doing at Pfizer in rare disease. It's a small population, but at the same time, we just need to zoom on those patients and healthcare providers that actually face a situation where patients are not controlled the best possible way. And then the execution is where we're going to win in the marketplace. So, I'm going to go in a very, very systematic way, but I'm pretty, pretty sure that these products can actually find significant success over a decent period of time.

Brian Abrahams -- RBC Capital Markets -- Analyst

Got it. Thanks so much.

Paul Levesque -- President and Chief Executive Officer

Thank you, Brian.

Operator

Our next question comes from the line of Edward Nash. Go ahead, please. Your line is open.

Adam -- Canaccord Genuity LLC -- Analyst

Hello, Paul and Philippe and Theratechnologies team. This is Adam on for Edward. I just have a few questions for you guys. The first is if you could comment on the status of conversion rate from EGRIFTA to EGRIFTA SV? And has this process slowed at all during the pandemic? And kind of what are you -- do you have any numbers on what percentage of the existing EGRIFTA users are now on the SV formulation?

Paul Levesque -- President and Chief Executive Officer

Thank you, Edward, for the question. Yes, the conversion has occurred, and it is being slowed down for a couple of reasons. But I'll turn to Jovan, who has the latest information on this. He will tell you again what has been the reimbursement status and when we believe that things will go back to normal. Jovan? Jovan, you may be on mute.

Jovan Antunovic -- Senior Vice President and Chief Commercial Officer

You're absolutely right, Paul. I was on mute. So, as it relates to the conversion question, the percentage of patients in Q1 that we've been able to -- the new starts, rather, that we've been able to start on EGRIFTA is hovering in the range of about 60%. We are getting close to having all our plans at the same level of where we are with the original EGRIFTA formulation. We are seeing a little bit of slowdown as it relates to some of the government payers taking action and putting EGRIFTA on -- EGRIFTA SV on formulary. But we expect that to -- that activity to pick up over the coming weeks as they move more and more toward virtual meetings to be able to address those aspects.

So, probably to your point about when will things get back to normal. I mean, that's a difficult question to answer. But likely, it seems to be headed toward, at least from the standpoint of the payers, that we're making progress. On some cases, we're slowed down a little bit, but I expect within about a month we should be in a position where the formularies, at least in the coverage, we should be in a position where we're fairly close to where we are with the EGRIFTA formulation.

Adam -- Canaccord Genuity LLC -- Analyst

Excellent. Thank you for that clarification. And any additional comments you can make about the status of the F8 formulation? And has an injector been identified for the use of that outlook today?

Philippe Dubuc -- Senior Vice President and Chief Financial Officer

Yes, Adam, it's Philippe Dubuc here. The -- where we're at, we pretty much found a dose that we believe will be bioequivalent, but we need to confirm this. So, we are planning a confirmatory trial that should start next month, but we need to be sure of that with our CRO, although we're not seeing any delays right now. We have identified a few injectors, injectors that are already on the market that have been used for a number of years. So, we don't believe that that will be the time-critical factor in the development and launch of the F8. But we have found a few, and we're confident that we'll get one that is adaptable to EGRIFTA.

Adam -- Canaccord Genuity LLC -- Analyst

Yeah. That's great to hear and then sorry, one -- yeah.

Paul Levesque -- President and Chief Executive Officer

Maybe just to remind that the F8 is stable at room temperature and even once reconstituted. Then for the patient to have a multi-dose vial in a pen will be a very significant advantage.

Adam -- Canaccord Genuity LLC -- Analyst

Yeah. No. No. It is true. And I just want to -- one more comment before I turn it on over. So, can you just comment again on whether there were any supply hiccups for Trogarzo or EGRIFTA, EGRIFTA SV? I know you made a comment earlier, but I just want to see if there's any additional detail or color you can provide. And thank you for taking my comments -- questions.

Paul Levesque -- President and Chief Executive Officer

I'm sorry, I didn't get that, Adam.

Adam -- Canaccord Genuity LLC -- Analyst

Oh, I was just wondering if there was any sort of supply hiccups or any sort of additional color you can supply for the EGRIFTA, EGRIFTA SV products.

Paul Levesque -- President and Chief Executive Officer

For the transition?

Adam -- Canaccord Genuity LLC -- Analyst

No. [Speech Overlap]

Jovan Antunovic -- Senior Vice President and Chief Commercial Officer

Supply.

Paul Levesque -- President and Chief Executive Officer

Supply, no. We have no issues actually. We have a lot of inventory as well. When we launched EGRIFTA SV, we manufactured a few lots for validation. And so, we have at least a year of inventory of EGRIFTA SV.

Adam -- Canaccord Genuity LLC -- Analyst

Thank you.

Paul Levesque -- President and Chief Executive Officer

Thank you, Edward [Phonetic], for your question.

Operator

[Operator Instructions] And our next question comes from the line of Andre Uddin. Go ahead, please. Your line is open.

Andre Uddin -- Mackie Research Capital Corporation -- Analyst

Sure. Good morning, everyone. Congratulations, Paul, on your appointment. In terms of marketing expenses, maybe Philippe, you could answer this, how much on a monthly basis should we expect the run rate to roughly drop, given that you're not going to be able to have any sales reps on the ground marketing to physicians, you won't go to conferences and reps won't be traveling? Thanks.

Paul Levesque -- President and Chief Executive Officer

Thank you, Andre, for your question. I do not have -- and I'll turn to Philippe in a moment who can comment more precisely, but I do not have this number. But the point is to say, obviously, we're going to be saving money from many of those lines, like traveling, like T&A and all of this. Question is, what is it that should be reinvested to support the business? What is it that needs to be saved to ensure that we don't jeopardize profitability? So we're going to put the cursor at the right place, but we are in a growing mode, and it's important that we don't short change ourself when it comes down to the potential of the top line for these assets. But I can tell you, we're going to do a deep dive to actually take a look closely at what type of expenses can be banked and how much of that can be reinvested in some of their activities.

Philippe, do you want to comment further?

Philippe Dubuc -- Senior Vice President and Chief Financial Officer

Well, it's difficult to say at this point, Andre, because we -- of course, there's a lot of expenses that will be lower. But the -- we're not planning any cuts for now. It depends on how long this pandemic lasts and how long our sales force needs to stay at home. So right now, we're not planning any cuts in personnel. Obviously, some expenses will be lower. But as Paul said, we might take the opportunity to look at how to redeploy that capital. So, it's difficult to say -- it's safe to say that it will be lower, but putting a number at this point is probably not doable.

Andre Uddin -- Mackie Research Capital Corporation -- Analyst

Okay. And just one other question. Given that COVID-19 has two HIV domains in its genome, just wondering if you're going to be testing Trogarzo against the virus?

Paul Levesque -- President and Chief Executive Officer

We didn't get that last part, Andre.

Christian Marsolais -- Senior Vice President and Chief Medical Officer

I can take the question.

Andre Uddin -- Mackie Research Capital Corporation -- Analyst

Yeah. So, given that COVID-19 has two different HIV domains in its genome, just wondering if you're going to be testing Trogarzo against COVID-19.

Paul Levesque -- President and Chief Executive Officer

No. Thank you for the question, Andre. So, Christian, do you want to answer that question, please?

Christian Marsolais -- Senior Vice President and Chief Medical Officer

Yeah, absolutely. The -- we had some decision, of course, like many of the other companies. And at the moment, based on the way the ibalizumab is working on the CD4 -- domain two of the CD4, the scientific rational might not be the best to some extent in terms of anticipating activity for COVID. But we're also trying to work with some lab to see if we can test the drug just in case we see some activity then. They are very busy at the moment, but in the coming weeks, I think that we'll most likely be able to test ibalizumab.

Andre Uddin -- Mackie Research Capital Corporation -- Analyst

Okay. Thank you.

Operator

And our next question comes from the line of Endri Leno. Go ahead, please. Your line is open.

Endri Leno -- National Bank Financial, Inc. -- Analyst

Hi. Good morning, and thanks for taking my question. A quick one for me. I was wondering if you can -- and Paul, you commented a little bit on this fairly soon, in terms of the discussions with the FDA and the EMA on EGRIFTA for NASH, I was wondering if you can provide perhaps a bit more of the concrete time line. And also, what -- any light that you can shed that in terms of what kind of requirements or the differences between the two agencies are that you are trying to bridge with a unified development approach? Thank you.

Paul Levesque -- President and Chief Executive Officer

Endri, thank you for the question. This is a very important program for us, and we want to make sure that we harmonize the feedback, and we have only one trial further that is going to be satisfactory to both agencies. So, we need to agree to endpoints, we need to agree to sample size or cohort size, and that's what we're trying to do at the moment. We just want to make sure that we have it right, and we want to do it with the F8 formulation as per the previous comments that we've made.

Christian, do you want to add anything to this?

Christian Marsolais -- Senior Vice President and Chief Medical Officer

Yeah. Well, the discussion with the FDA and the EMA is taking place now because we received the feedback, and we're pleased with the feedback that we received. As you know, it takes time because by the time that you send your response, you have another 60-day or 90 days. But everything is aligned at the moment for a start of the program toward the end of this year. And the goal is to have a common protocol for both EU and the US. And as Paul mentioned before and Philippe in his answer for the F8, we'll be starting the confirmatory study with the F8 in the coming weeks. And based on those results -- based on the results of the pilot, we're quite confident that we can show bioequivalence with the confirmatory study. Then we would be ready to start the NASH program at the end of this year with the new formulation, which will be a multi-dose vial. That's -- we're very pleased with the discussion so far.

Endri Leno -- National Bank Financial, Inc. -- Analyst

Great. Thank you very much.

Operator

[Operator Instructions] Our next question comes from the line of Doug Loe. Go ahead, please. Your line is open.

Douglas W. Loe -- Echelon Wealth Partners Inc. -- Analyst

Yeah. Good morning. Thanks very much operator, and Paul welcome aboard. I wanted to stick with Trogarzo a little bit, if that's OK. A little bit of a good news, bad news story in the quarter, in our view. The positive that it's up 17.4% year-over-year. Bad news is that it's only up 17.4% year-over-year during so early days of launch. So Paul, just wondering in your early days, looking at the market opportunity for Trogarzo specifically, if you agree with our analysis and others that the target market, even just in the US, is somewhere between 10,000 and 20,000 patients, somewhere in that range. Current sales levels would still imply that there are more drug-resistant patients who are not on Trogarzo therapy than who are. Just -- I'm just kind of talk through the competitive landscape there. What the barriers are that you need to overcome in order to enhance adoption? Is it pricing? Is it the fact that it's administered in infusion centers? And is that an intractable problem to consolidated sales growth going forward? And I'll just sort of leave it open-ended there, just kind of comment on how you think you might be able to kick-start quarterly sales for Trogarzo in future periods. I'll leave it there. Thanks.

Paul Levesque -- President and Chief Executive Officer

Thank you, Doug, for the question. I think this is a critical one. So let me give you a few bits from my perspective, again, after six or seven days on Board. Trogarzo is indeed approaching the marketplace with an offering that is significant because there's an unmet medical need there. There's many, many patients that are facing resistance at this time. But to your question, what is it that needs to be done? I think Trogarzo is challenging the mindset and the paradigm of treatment.

Let me take and draw a parallel with rheumatology. In rheumatology, first-line medicines are infusion. The Remicade is an infusion medicine, has been for many years, and it's still standard of care. In this category, doctors switched to oral combination a while ago. And now we have to challenge them, challenge them to say, the infusion is half an hour, twice a month, the drug is well tolerated. And more importantly, the mechanism of action is probably the best one you can have because it prevents the virus from entering into the cells. So we just need to do a fair amount of education, education that our MSL can do, our opinion leaders can do, our reps can do by following up on these sort of webinars and calls. But I think that if we don't step back a little bit and go high on science, doctors will not create that sense of urgency for themselves that they need to have. That's one.

And second, I think that I want to review very, very deeply the type of pool strategy that we have because I'm absolutely convinced that if patients were to know that this was an option for them, knowing that whatever happens to them will happen for life, I think that many of them would say, I wouldn't mind having an IV formulation twice-a-month infusion like we see in other categories, providing that this is the best long-term strategy for me. And I think that this is where we are. We need to challenge the mindsets of both providers and patients. And that is why I'm going to review the plan and put emphasis on the education phase because there is a bit of education to do. And I think that if you don't -- you go too fast to selling without doing justice to the education component, you won't succeed in the marketplace.

So infusion -- IV infusion is a fact. If this medicine was not IV infusion, then obviously, it could open up to even a bigger set of patients. But at the same time, I don't see for many resisting patients the IV formulation being an obstacle, providing that we put that into perspective with HIV providers. Thank you for the question.

Douglas W. Loe -- Echelon Wealth Partners Inc. -- Analyst

That's good feedback. Thanks, Paul.

Operator

And there are no further questions in queue at this time. I turn the call back over to our presenters.

Paul Levesque -- President and Chief Executive Officer

Well, thank you very much. So, as there are no...

Operator

Looks like we don't. Go ahead, please.

Paul Levesque -- President and Chief Executive Officer

No? Okay. So, as there are no additional question at this time, I want to thank everybody for being on the call this morning, and I wish you a very pleasant day. Thank you.

Operator

[Operator Closing Remarks]

Duration: 39 minutes

Call participants:

Denis Boucher -- Vice President, Communications and Corporate Affairs

Paul Levesque -- President and Chief Executive Officer

Philippe Dubuc -- Senior Vice President and Chief Financial Officer

Jovan Antunovic -- Senior Vice President and Chief Commercial Officer

Christian Marsolais -- Senior Vice President and Chief Medical Officer

Brian Abrahams -- RBC Capital Markets -- Analyst

Adam -- Canaccord Genuity LLC -- Analyst

Andre Uddin -- Mackie Research Capital Corporation -- Analyst

Endri Leno -- National Bank Financial, Inc. -- Analyst

Douglas W. Loe -- Echelon Wealth Partners Inc. -- Analyst

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