Q2 2021 Theratechnologies Inc Earnings Call
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Ladies and gentlemen, please standby your their technologies conference call will begin momentarily once again, ladies and gentlemen, please stay on the line.
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Good morning, ladies and gentlemen, and thank you for standing by welcome to this their technologies conference call. At this time all participants are in a listen only mode. Following the presentation. We will conduct a question and answer session and instructions will be provided at that time for you to true up for questions.
If anyone has any difficulties hearing the conference. Please press star followed by zero for operator assistance at any time I would like to remind everyone that this conference call is being recorded today July 15th at 830, a M. Eastern time and I would now like to turn the conference over to Denis Boucher, Vice President Communications and corporate Affairs. Mr. Boucher. Please go ahead.
Thank you very much Mr. Paul <unk>, President and Chief Executive Officer, Sarah and technologies and Mr. Phillips Senior Vice President and Chief Financial Officer will be the speakers on today's call a Q&A period, we will follow their presentation.
And before Paul begins his remarks, I'd like Nash Bioterror and technologies to read the following message regarding the forward looking statements.
I would like to remind everyone that there are technologies 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 and preparing these forward looking statements several assumptions were made by.
<unk> technologies and there are risks that results actually obtained by the company will differ materially from those statements as a consequence the company cannot guarantee that any forward looking statement will materialize and you are cautioned not to place undue reliance on them. There are technologies refers current and potential investors to day.
Forward looking information section of its management's discussion and analysis issued this morning available at Triple W. Dot <unk> dot com and on Edgar at Triple W. Dot FCC that she will be forward looking statements represent very technologies expectations as of July 15th 2021.
As may be required by securities laws, Terry technologies does not undertake any obligation to update any forward looking statement, whether as a result of new information future events or otherwise I would not like to turn the conference over to Paul.
Thank you Denise good morning, everyone and thank you for being with us today.
Much has happened at a Saar and technologies over the last 6 months as we continue to integrate stepwise changes that are intended to best optimize our business and position the company for long term growth.
And interesting aspect of our story that is not always understood. However is that we have 1 split and a clearly established revenue generating commercial business with potential for upside and another foot in and extremely promising pipeline in early stage oncology late stage Nash development and lifestyle.
Lifecycle management for our commercial portfolio.
We firmly believe that the phase 1 program, if and waiting and where lead peptide drug conjugate th 19, and true for treating shortly and expressing cancers and our phase III development program that and waiting to somewhere in and for the treatment of Nash both hold true promise to benefit patient communities in areas of unmet medical and.
Need as well as our stakeholders as we continued to strengthen our foundation for growth.
And we announced today, we have completed and we're in discussions with the FDA and EMA regarding the phase III Nash program and Havent finalized phase III clinical trial design and are now in a position to finalize the protocol.
As we review the additional resources and are now required to conduct a phase III clinical trial in Nash, we decided that it wasn't the best interest of the company and our stakeholders to evaluate opportunity that will allow us to more effectively execute this program, including initiating a search for a potential partner.
Late stage development.
While this will alter day planned timing of the phase III clinical trial initiation, which was previously expected to begin in Q3 of calendar year, 2020, 1 by seeking and securing a partner.
And then potentially add additional resources and capabilities that will be of great value as we advance this exciting program toward a potential approval.
We have already kicked off this initiative and retained the services of and external you Wednesdays 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 true.
And prudently shaping and future technologies, we believe that we are keeping to our strategy and our promise to best serve patients and unlock shareholders value via a 2 pronged approach.
Ovation 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 our future partner and.
In particular.
Just some Oregon has demonstrated a strong and well established track record of safety and efficacy over 10 years of product data and HIV associated lipodystrophy.
We had a strong intellectual property position was further strengthened by newly issued patents for the treatment of liver disease and extend through 'twenty 4.
We've collected extensive data from investigator initiated studies and the hard to treat HIV Nash patient population and that shows just some moral and unique mechanism of action and addresses the underlying cause of liver disease.
With its new potential ethane formulation and multi dose pen injector to some more and could have the opportunity to provide health care providers and patients suffering from Nash in HIV related Nash and new treatment option and greatly improve adherence after some warning and the treatment of this debilitating disease and.
More importantly, we have received Saturday from the U S and EU regulators and have finalized a comprehensive phase III Nash trial design.
In terms of regulatory discussions and the finalized phase III trial design is planned for a multicenter randomized double blind placebo control 1 to 1.2 part study designed to evaluate the safety and efficacy of the sub orland in liver biopsy confirmed patients with any ASP.
For or at least 4 and stage 2 or 3 fibrosis.
The clinical trial will also use the fertility analysis that would be conducted after the 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 and early treatment effect with just some warning thats been observed to determine if the study should proceed as planned.
We will be and are positioned to pilot and SBA Lee after approximately 1100 patients, including 75 to 100 people living with HIV and completed 18 months of treatment and have received the second liver biopsy.
Following potential approval and additional 800 patients are expected to be enrolled to continue measuring clinical outcomes over a period of 5 years.
And like I said earlier, and we'll 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 programs through development and toward approval.
This strategy will also allow us to continue to invest and further strengthen our commercial business and advance and we're promising sort 1 positive technology and through clinical development as quickly as possible.
Turning to our oncology pipeline and continued to be very excited about the sort, 1 positive technology and shorts and and expressing cancers and our recent discoveries.
Ordinary from preclinical work continued to confirm to support Trinity.
As I've said before and 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 and people finding on the day and time its aesthetic effect and Tolerability of Th 19 O..2 further supporting th 19, low twos prospects has the promising cancer and getting platform technology, and certainly and expressing cancers.
These results demonstrate that th 19, O 2 had better and time and does static activity when compared to Docetaxel alone when administered at equal concentrations in there along with a status cancer model expressing the fourth 1 receptor.
It is well known and that the survival rate for metastatic cancer is extremely low and that's worth 1 receptor expression increases as cancerous progress.
These new findings confirm that by targeting <unk>, 1 receptor each 19, and what you may potentially be effective and the treatment of metastasis and most importantly, these preclinical findings if confirm and human.
Our promising signs that there may finally be and wait 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 sort 1 positive technology.
Our fourth 1 positive technology, including Th 19, new true is truly groundbreaking and.
Answering treatment approach based on its mechanism of action and compared to cytotoxic drugs like docetaxel or doxorubicin th 19, and what to allow us for increases in interest salad or concentration of the cytotoxic payload offering a different PK profile, while increasing the therapeutic window of the cytotoxic.
Drug being conjugate it well.
And what is also extremely important when comparing th 19 O 2.2 and equivalent dose concentration of a cytotoxic drug like Docetaxel alone is the absence of neutropenia and I.
Our preclinical models Th 19 O true has not shown to induce neutropenia and potentially allowing for sustained treatment better tolerability and increased efficacy of <unk> 19.
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 1 part a of this study in Q4 of this calendar year.
By year, and we expect to have completed the part a dose escalation study to establish the maximum tolerated dose and informed and next step of the phase 1 part B basket trial, which is expected to begin in early 2020.2.
Okay.
And we think about the potential runway for growth that is ahead of us, especially as we move our pipeline of potential medicines closer into approval. It is helpful and insightful to look back and how the biotech market has matured and last decade.
1 thing of note and has stood out with and last few years is just how resilient the biotech industry has been.
This is the case, whether we're talking about driving innovation and healthcare or talking about biotech legitimacy and an investment class.
Investors are looking to the sector for sources of new technology innovation and approaches that will transform patients' lives.
And third technologies, we have in line and our own way forward with these ideas in mind to keep up with change driving innovation and evolve our business and anticipation of the strong growth that is to come.
We've taken cues from the biotech industry, historically and model best in class standards and placed a strong emphasis on day need to address 3 key areas of importance.
The first is building talent.
And he is handling complexity, and finally, improving commercial and development execution.
Oh and disbursed area of importance, we've placed a strong emphasis on near term execution to best position ourselves for success. When you looked at and our recent investment which extend our human capital. We have brought on experienced talent, that's already assuming critical leadership roles and trained to successful.
Execution of our strategic objectives.
Recently, we welcomed the other day Dupage, Vice Presidents, who will lead our human resources function, Mr and Dupont brings more than 25 years of experiences and was more most recently vice president and instead of human resources and commend chef pharmaceuticals.
And Trey will ensure that we are attracting the very best talent in the industry to help us grow the business any will ensure that we retain our current exceptional group of employees.
In addition, Daniel book was brought on to lead our business and corporate development efforts and this new create growth Danielle will support the company's commercial and R&D strategic partnerships and alliances and assist and building out our relationships in the industry.
Having strong leadership and these key positions gives us the ability to manage the complexity of operating and commercial and R&D business through the pandemic and beyond.
We really look forward to their leadership and contributions and they will bring to third technologies and their respective.
And rolls.
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 is a prime example of how the organization and I had to handle complexity. During this time.
For us this has been centered around our commercial business.
That and Symphony 1 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 take away related to our company was that through 2020 and into early 'twenty 'twenty..1 overall genomic resistance testing was down 25 per cent compared to previous periods.
This is pretty significant at this day. So 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 regard zone.
During the second quarter, we continued to see this impact our top line results in particular with regard zone as patient and prerecorded testing continued to be hindered by the pandemic created strain on health care facilities and physicians.
The introduction of competitive pressures from newly launched and therapies for the treatment.
Treatment of HIV you may have also impacted the U S sales performance with regard zone during the quarter.
And do you we continue to work toward obtaining and appropriate price and widespread reimbursement, but regards and wing key European countries and believe we have created a strong foundation for our medicines for 1 dependent make associated lockdown measures are fully lifted.
Nonetheless, both and do you west they need and we have continued to enhance our medical years old 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 hcp's to be better informed and with better resources to prescribe our medicines and helping to ensure that patients had deere to prescribe treatment plans as they move through their patient journey and the effort to improve their overall health.
And I touched upon in the third and final key area of importance, improving commercial and development execution.
We continue to take the necessary proactive measures to build down and were commercial business, while being mindful of the short term impact from Covid on the industry may continue in the U S and you until we have fully exited this is.
Stained 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 and infrastructure that was built started to bear fruit on the grip dies vs sales during this quarter, which grew 12% over 20.
'twenty.
We are encouraged by the incremental gains and a grip day to be sales in the first half of the year and believe that this is indicative of where a 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 and steady and incremental ramp up and ready and us going forward and.
And we'll also served 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 2020, 1 and 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 Filip now to discuss our second quarter results Phillip. Please go ahead.
Thanks, Paul and good morning, everyone.
So all day revenues for the second quarter of fiscal 2021 were $17.8 million and increase of 4% over Q2.2020, mostly due to an increase and a S V sales and hampered by lower sales of Truecar zone net.
Sales of a grifter as V were $10.3 million up 12% from the same period last year. When we recorded sales of $9.3 million.
Unit sales will be grifter relative relatively stable compared to last year, but net sales were better due to a higher net selling price and lower rebates to payers.
Given the switch from the Drifter S Z from the old version of Big Grifter, which carried higher percentage discounts and a grifter SV.
With regards to revenues were down 6% year over year as a result of lower sales to specialty pharmacies and the effect of the ongoing COVID-19 pandemic.
And the resulting and 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 <unk> were positively impacted by unusually large orders by pharmacies, which has since stabilized.
And the E U.
While the Covid situation is still problematic.
With respect to patients getting on boarded on therapy, our team and Europe continues to identify patients. We believe that the latter part of the year may provide incremental gains price.
Pricing discussions are progressing and the EU and.
And the reception has been positive.
With this in mind, we have laid the groundwork to growing revenues of the thorough technologies franchise and.
And I 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 from the same quarter last year. The decrease is mostly due to higher gross margins on a grifter as compare to rift out as well as a lower transfer price for <unk>, given the achievement of a pre determined.
Net sales in Q3 of last year.
R&D expenses amounted to $6.4 million, and Q2.2021 compared to $3.6 million from this.
Same quarter last year.
This increase is largely due to higher spending and oncology with the initiation of our phase 1 trial.
Increased activity related to our Nash program, including on the new F 8 formulation.
Increased spending in medical and patient education, as well as higher medical affairs initiatives in Europe.
For the 3 months 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 and Q2.
Slightly from $3.7 million in Q2.2020.
The increase and G&A expenses is largely due to increased overall business activity in 2020, 1 compared to 2020.
This increase is partly offset by 1 time items incurred in 2020 as a result of the retirement of the company's previous CEO.
And Q2, 2021, we recorded $1 million and net finance costs compared to $1.4 million in Q2 'twenty 'twenty.
And as previous state 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 $378000.
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 $700000 of cash which explains why our balance our cash balance has remained virtually identical to that of February 'twenty, 8 'twenty 'twenty, 1 and approximately $57 million.
I will now turn the call back to Paul for some closing remarks.
And thank you for the.
Looking back at the first half of the year, we're pleased with the organization that we have to come.
And innovation that we are developing is really special and it has the ability to greatly improve and in many instances transform patients' lives across areas of high unmet medical need.
And 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.
And 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 and we will now open the call to take your questions as the operator mentioned at the beginning of this call and I would like to remind you and you can submit a question enrich and form via the webcast platform. Please register on the webcast link which is available and the events section of our Investor website to summit Youre.
Okay.
Yeah.
Hello, Ladies and gentlemen, if you have a question or a comment at this time. Please press. The Star then the 1 key on your Touchtone telephone. If your question has been answered you wished and move yourself from the queue. Please press the pound key.
Our first question comes from Andre who didn't with research capital.
Good morning, everyone thinks in terms of.
And I should potential partnership, which I think is actually a great idea and can you. Please describe your ideal partner.
And look for them to fully fund and the phase III trial or will you look to co develop it and then later co promoted.
And also with this potential partner would you look to co promote grifter for HIV. Thanks.
Well, thank you and is ready for the question and I'm glad you feel that that way. This is certainly you.
You know our position of strength that we're facing at this time, we have and approved protocol and our lap and we're not too many companies that can actually in such an area of unmet medical need be.
And in a position like this when it comes down to the ideal partner I think that it can take different for them and it's kind of <unk> 2 actually.
Take a look at all the possibilities that are ahead, but there are certainly the 1 that comes with you know a co development co promotion and so commercialization down the road other companies may decide to actually and they want to invest the day once a day.
And they would want us to continue the development and maybe had a piece of the commercialization later on so I think that you know we have already with our advisor.
<unk> has done a mapping of the potential pharmaceutical companies are big companies medium size with an interest in Nash and we know what these companies are and I think that and we'll see down the road what type of partnership we can find with them, but 1 thing is for sure.
Nobody knows to somewhere and more than we do so we need to actually keep out investing keep unfolding our plan and we're fully committed to put that to life.
And with a partner or with other manille means that we're gonna find and the upcoming months.
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.
And 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 and the bag and the U S and we have only 1 product in Europe. So we'll take a look at how we can identify what I call. The drug companion that could actually synergize with the portfolio that.
We have and that would increase and critical mass of assets that would make sense for the target of doctors that we are calling on and at this time. So we will actually do some work. We've already started again to pandemic made some of that more complicated, but we will look into it and we'll see if we find that sweet spot and again.
And with the ideal companion.
And just also 1 last question here I just saw that.
And they grift, a phase 2 trial being run and with 100 and HIV patients with Mci or mild cognitive impairment can you discuss how this trial came about and when the results from that trial or spark did roughly if you know.
Okay.
It sounds and do you want to handle this.
Absolutely, yes, Andre. Thank you for the question I don't know Andre if you remember, but we have done first.
A few years ago, a study and non HIV and the general population and milestone cognitively impaired patients.
With Doctor and Vitiello, and we have shown positive results.
Following that study that was also studies, showing and HIV that and increased waist circumference and is also associated with mild cognitive impairment and doctor pressed south or and Ron Ellis I've been working with us.
To start that trial and that's trial that's been ongoing for a number probably about 2 years now we opened up their recruitment will be completed in 2022 and if there's a 6 month study then we should potentially see results and 2023.
And it's a good rationale for base based on the preceding studies that were done with a grip Tong.
So all the patients and that trial or HIV and.
All of the basins and that trial, our HIV. It is linked to a city that doctor running less epidemiological study that Dr. Ron Ellis and done in the past showing the link between increase increased waist circumference, which has increased the visceral adipose tissue or ectopic fat and decrease and cutting.
Okay, great. Thank you that's it from me.
Okay.
Our next question comes from Edward Nash with Canaccord Genuity.
Hi, good morning, guys.
So I wanted to understand so I know that we just got the protocol now.
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're looking at only Hum Nash patients that were the head HIV.
So I'm just trying to understand now that you're now that you're deciding to 2 partner I mean, your cash balance is what it is which is going to drop his decision, but but we already kind of knew what your cash balance was been too. So just what's changed between since last year and and now with regards to your decision to look for a partner for the.
The phase III Nash.
Well, thank you very much.
And this and what has changed is that the.
The cohort size now has increased.
And a smooth and negotiation with the agencies a day.
Vascular 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 cost 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 we have a protocol and he is ready to proceed and.
And I think that if there is a moment, where we can with credibility.
Attract and discussed 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 you know.
First and you 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 you.
You know team up and take a look at the protocol.
It's not too late and we can weekend and do different things if needed but the protocol is ready to proceed and we have all the confidence and the world that this protocol will tip. This too and approval so going back to your question I think that you know.
What has changed is the additional cost and complexity of this trial and I think it's prudent and probably a good thing that we explore the opportunity of having a partner and at this time. Thank you for your question.
And if that was helpful and.
And I guess, the second parts of that and just with regards to modeling. This I mean, obviously this could go this can take many different forms as you mentioned.
But of the phase III.
Company is running phase III right now for Nash and they're all they're all in this alone and.
Wanted to know on that side or have you already guys have have you already had people having accessed.
The data on a confidential basis.
Showing interest or is this kind of and effort. That's now now that you have a BD Guy on board is this something that's just now starting new for.
From scratch.
Well I'm not going to get into the details, 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 protest process step wise and we'll let you know once we have more day.
Same.
Got it that's great and then my last question is just with regard to the Feight formulation. The pin formulation can you remind us again when you expect to have that available for us to replace the Grifter SC.
Because it sounds and you want to absolutely.
Plan is to submit the dose and the.
First quarter of 2020, 2 and then it should be available.
It's a 5 month review then it should be available towards the third and fourth quarter of 2022 and and the main reason is that we need to gather more adult he'd like the paint is relatively new and we are gathering stability data partnership line.
Great. Thank you so much guys.
Our next question comes from and Brilinta with National Bank.
I'll.
Pick up again with the Nash and I have a couple more after that but.
Question I had is that what possibilities and you guys foresee that a partner and they ask for general and nasty and I, probably try and agreement.
Would you mind repeating your question because the line was and all that clear and we Couldnt hear you very well sure yeah.
So what is the possibility that you guys foresee that a partner and May ask for a general Nash data prior to and agreement.
Okay.
Well I mean day.
This is an interesting question, but you know we've got a ready and.
To proceed protocol at this time that there's been negotiated so you know I think that the 2 agencies, where you know pleased.
Pleased with what we actually presented in front of them and quite frankly over the last 12 months, we have rather and our support for test some warranty and in the general population you would remember that to get to this point, it's been a pretty long journey.
Started with you know, having an interest in Nash and the HIV population and base.
Animal based with based on our early interactions with the agencies. We actually were told that we should and I actually think about the general population and.
And we actually look forward to that and we ended up running and we're support you know among the experts and the industry and I think now we're all set to go pitch sounds do you want to add anything there and maybe and we just to and I'll go back and the scientific size and the mechanism of action, There's a clear association between.
Decrees release, and G H and increase this royalty post tissue and increase and liver fat and both patient population non HIV and HIV and Thats really the mechanism of action that we're targeting the only thing that we have done so far we have done studying with the grifter and both HIV and non <unk>.
And both patient population, we have shown a good similar degrees and this 1 was both tissue and and the HIV population, we have shown the decrease and liver fat of about 40%, which we think it is the same because there's a good correlation between the degrees and this 1 will be post tissue and liver fat, therefore, and the general book.
Operations and it should be similar and all of our experts who work and the bed and expert and who worked with told US that this is the best 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 into the general population.
Okay, great. Thank you for that actually 1 more perhaps for Christina.
If you can please refresh us on the current end point from the last protocol and versus your prior expectations and results already obtained and trocar so patch.
For you mean for a 4 day grifter and us in terms of the endpoint for the for the Phase III trial, yes. Please.
Yeah.
Looking at at the moment is a normalization and the Nash for patients will be.
And we'll have a nash score of 4 and more at the entry and fibrosis book 2 or 3 we're looking at the normalization of mass and 10% of the pace and this is a primary endpoint.
Without and he gets a impact on fibrosis.
But fibrosis will also be assessed.
And fibrosis will it be a secondary endpoint and based on the data and a recent publication from Dr. For lumber, we know that the decrease of 30% and liver fat is associated with normalization of Nash and is also associated with decrease of fibrosis.
And we're quite confident and those 2 endpoints for the phase 3 program.
Okay.
Thank you my other question has more to do with the sales in the quarter for Truecar. So 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 and rebates.
Do you have a few I think you had a few statements and your speech and you go ahead.
Oh sure sure. So Andrew it's it's really a mix of everything. So we are we did see lower lower.
Unit volumes.
With regards and what's been more affected by the pandemic, especially if you don't win immuno compromised patients are told to stay at home.
So that that was affected.
And affected the the unit sales and affected new prescriptions as well.
Remember last year, there was a huge spike and orders from from.
Pharmacies at the beginning of the pandemic, so that kind of normal doubt 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 -6% and <unk>.
<unk>.
Okay no great.
Great. Thank you.
And we're looking more into specialty volume 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 are pretty much open and do you watch the last quarter and as we see new cases.
Starting to ramp up and all that I mean should we expect sales volume at least flattish or a bit below.
I'll turn it upwards.
Well. Thank you for your questions. We are into this for growth. So we're committed to with regards though we're committed to Arista and 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 what to our physicians and patients somehow so.
We are optimistic that we're going to be firming up the performance of both asset.
And I think has slowed down and has slowed down in Europe due to the pandemic and the locked down and now we will resume our pricing and negotiation what is important to me quite frankly that this drug <unk> will be relevant to patients and HCP and it's going to work hard because we know that they need you know alternatives to treat.
Their patients so we foresee growth with both handsets and the upcoming months and we're going to work hard to make that happen and I think that you know I would leave it at that for now.
Okay, great. Thank you and 1 last 1 from me. If you guys can talk a little bit in terms of cost cost how do you see them over the next 2 to 4 quarters.
And if you want to take that.
Well until we are we start the Nash trial.
You can pretty much assume that.
SG&A front and even on the R&D front and it should be relatively stable. So until we we do start the Nash trial.
This quarter is probably a good proxy.
Great. Thank you very much thanks, Mike.
And let me ask and Lee.
And your question again, I'd like just to say that there's new dynamics going on and HIV as new competitors are launching but.
But at the same time.
The market is moving to long acting we have a long acting compounds with regards though so we're going to make and we're going to make sure that that gets to our physicians and that D. C. The benefits of prescribing provides though in the mix of drug and they need to take.
Prescribed to control patients.
Thanks, again, ladies and gentlemen, if you have a question or a comment at this time. Please press. The Star then the 1 key on your Touchtone telephone.
Okay.
Oh is it seems as we do not have additional questions from analysts we will now turn to questions submitted by other participants and riding.
The first question that we have is.
And if there is a timeframe that you expect to finalize a partnership in Nash.
And 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 it a little bit of time now and somehow we've been slowed down to better accelerate and 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 day.
The slowing down and aspect of this will be forgotten and very very fast. So what is more important for us at this time. It is really to find the ideal partner and I think that timeline, we will take care of itself along the way. Thank you. Paul another question here, if we don't find a partner.
When we decide to proceed on our own or just give up on it.
And that will certainly not going to give up we have you don't want per.
Protocol that we weren't absolutely the harder to get to where it is now and that can actually make us enter the market.
First and second or third and and be extremely relevant in an area of unmet medical need. So we're just as I said at this time its premature to actually go and work.
And speculate over what would happen, but the partnership is on the table at this time, we've got and advisory company that is helping out with the process has started the outreach is on and will will actually meet these organizations unveil the data get them to see what we have seen get them to actually.
<unk> interact with the advisors and Kols that are supporting this and I'm very confident that they're going to want to actually be part of it.
Thank you before we.
Go on with more questions I'd like to remind participants that you can submit questions in writing on the webcast platform.
You do have questions. Please don't hesitate to submit it.
Now R&D oncology platform given the timeline presented during the last webcast.
Can it be assumed that we are in the therapeutic dosage level of Docetaxel.
And you want to provide an update yes absolutely.
And I won't go into specifics of the trial as you know we have to manage the study.
And naturally through some expense and make sure that.
If we announce something that everything will be validated but at the moment the recruitment is going very well.
We think patients and those 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 base and ensuring that everything is done.
And we have the appropriate data from the prior cycles and it's growing.
Increases.
And for weeks and we started the first patient as you know on March 23, and then the cities per this proceeding well and we also now have increased the number of sites. We started with a per site of Doctor started Gettysburg M. D. Anderson has been open for a few weeks and we now have opened 2 additional sites.
Movement and Covid.
Channel.
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.
At the moment all force sensors are active and screening patients at the moment, we have 2 sites that are recruited basins.
But in the coming months. The other sites will also have patients to this program and <unk>.
Very much.
Regarding our HIV business.
With the focus.
And increasingly on oncology.
And what's what's what's to think of the HIV business well.
<unk> business is that we've got a commercial and.
Leg to our business and we're generating revenue so we shouldn't be ashamed level generating revenue and a good thing and what is more important to me is even the fact that we are building capabilities for the future.
We have and organization in Europe, we have and organization and the U S. We're calling on doctors, we've got <unk> sales on the ground. We're doing what mid size large sized pharma are doing and that's gonna be handy and the future.
Especially as the Nash program is going to unfold I think theres going to be a long prelaunch phase associated to that.
And having people on the ground capabilities, having people no inside out and what <unk>.
Great day is all about will be a great asset for ourselves and also for potential partners. So the HIV business for now is important and generating revenues and it allows us to build capabilities for the future. Thank you.
Going back to the oncology platform in terms of efficacy are there any expectations coming out of our phase 1.
Yes.
And when would we start with the with.
The objective of this phase 1 trial, which is really to determine what will be the next month's break from those of the drug which will be the dose that will be used and the phase..2 however, as you know that's that he has done and cancer patients that are events and resistance to prior treatment and it is possible that we observed some efficacy.
And this is why we think and based on the number of cycle and the length of time. It takes to confirm if there is a response because if we see and impact on the tumor shrinkage, we still need to wait for 3 months before we can confirm to response that would be and are positioned to.
And the bulk some information and the port quarter of 2021.
That's great. Thank you discount.
And 1 additional question in terms of the safety is there.
Do we expect to see neutropenia at.
That's scheduled doses.
Once again. This is the same thing is going to talk about the results are to those that were up exactly at the moment.
However, based on the animal data that we have seen and based on the Tox program that we have conducted we certainly do thing that we won't see neutropenia at EQM Overconcentration of Docetaxel.
We will be able to dose escalate higher than the dose of Docetaxel presents the used to treat cancer patients and once again, we think that this data will firm up and we would probably be able to announce something and the fourth quarter of 2021 on the book.
Thank you.
I'd like to remind participants that if you would like to submit a question and writing you can do so.
And our webcast platform and.
And I will give a few seconds for additional questions to come in.
Uh huh.
There doesn't seem to be more questions coming in this morning. So at this time, we will conclude this morning earnings conference call I would like to thank everyone for being on the call. This morning, and on behalf of variable and a year at their technologies and I wish you a very pleasant day. Thank you.
Ladies and gentlemen, this does conclude today's presentation. You may now disconnect and have a wonderful day.
Okay.
Moving.
And.
And.
Yes.
Okay.
And.