Q4 2020 Theratechnologies Inc Earnings Call
[music].
Ladies and gentlemen, thank you for standing by welcome two disparate technologies conference call. At this time all participants are in a listen only mode. Following the presentation. We will conduct a question and answer session instructions will be provided at that time for you to queue up for questions.
If anyone has any difficulties hearing the conference Please press star zero.
Star Starkey, followed by zero for operator assistance at any time I would now like to remind everyone. This conference is being recorded today February 25, 2001 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.
Yeah.
Thank you and welcome Mr. <unk>, President and Chief Executive Officer, There are technologies and Mr. <unk> <unk> senior Vice.
Vice President and Chief Financial Officer will be the speakers on today's call.
On Q&A period open exclusively to financial analysts will follow their presentation.
Before Paul begins his remarks I've been asked by <unk> technologies to read the following message regarding forward looking statements I'd like to remind everyone that there are technologies remarks.
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 <unk> technologies and there are risks that results actually obtained by the company will differ materially from those statements.
A consequence, the company cannot guarantee that any forward looking statement will materialize and you are cautioned not to place on <unk>.
So on that.
There are technologies refers to current and potential investors to the forward looking information section of its management's discussion and analysis issued this morning and to the risk factors section of its annual information form dated February 24th 'twenty 'twenty, one available at Triple W. Dot <unk> Dot com.
And on Edgar at Triple W. S Dutch you'll be passed.
As an exhibit to its report on form 40 F dated February 'twenty five 2021 on debt.
<unk> technologies public filings.
Forward looking statements represent very technologies expectations as of February 25th 'twenty 'twenty, one except as may be required by securities laws. There are technologies does not undertake any obligation to update any forward looking statement, whether as a result from new information future events or otherwise I would now like to turn on the.
Conference over to Paul.
Thank you Danny and good morning, everyone and thank you for being with us today.
As we present, our financial results for the fourth quarter of 2020 and reflect on what works.
Formats, we are proud of what we have accomplished especially in a year, where global pandemic challenge our business model.
The company on joint less than a year ago on undergone significant changes I did eastern technologies of the future you won't have little over seven months with the company on that thanks to the continued progression of our IP.
Last April during my first quarterly call as CEO I said that I would take 60 to 90 days to review our business model and I didn't define the levers of success and investment required to fully recognize our potential.
I quickly realized that COVID-19, 19, or not changes where needed to optimize the commercialization of <unk>.
Our two unique products in HIV.
It also became clear that two instead of a range of sales performance Ultra grip Andrew Barnes.
More patient and HCP education was required to properly establish the benefits of our medicines as.
As such it.
In the second half of the year changes were implemented to adapt our business model and increase our digital and virtual marketing initiatives.
Goal is to improve patient I building upon real world evidence windstorm guidelines and had been stickier people living with HIV in the pandemic environment.
For instance, as telemedicine consultations between Hcp's in Asia increased we launched tools to allow both doctors and patients to have meaningful conversations and on.
On treatment option and to better understand the patients condition initiate their treatment with one of our HIV medicines maintained their clients.
We added to our education program, the latest information, which links visceral fat to worsening COVID-19 symptom severity. This.
This is an important message that supports the urgency to treat digital as a serious metabolic condition, particularly during the pandemic and to differentiate us from a lifestyle disease.
With regards though we have deployed the similar approach developing online tools and virtual events aimed at educating hcp's and patients on the importance of maintaining a non detectable virus.
For people living with HIV are detectable unquenchable harm low 10 has huge implications on their overall health and environment patients are at increased risk on HIV associated morbidity and mortality.
In fact, we branded a new program called equals Z, which tends toward viral load equals one mobility and we keep selling with regards those long acting profile as the key benefits versus the competition.
We're also developing tools to help hcp's identified people with multi drug resistant HIV and have exhausted options to treat their disease.
Goal here is to create a sense of urgency for doctors to treat there on central ambition.
Our new approach in patient activation Leverages HIV digital influencers.
And social media to drive patient identification and request.
Furthermore, our new community Vietnam, a team performs and digital outreach to case managers in high prepayments area should help identify patients at risk of Nyquil dystrophy, or a detectable viral load.
With these we wish to empower patients to own their condition, which will lead to superior interaction with H C vs and ultimately better.
The changes and improvements I, just mentioned could not have been accomplished on the Wellington grade and cross functionality between our sales medical and marketing teams and as a result, our commercial businesses now are more efficient reaching out to patients and HD piece in a more virtual environment.
However, like many other companies in the healthcare space. During this pandemic mutations to having face to face interactions have made it challenging to recognize more robust sales growth.
The urgency to treat multi drug resistant patients is not on understood. The HIV community and physicians may lack the resources to trigger a change.
In fact, our main barrier that we have experienced through the pandemic has been getting patients initiated on <unk>.
In order to when you say three months, regardless of what patient must be screened at the hospital or clinic. However, patients had been asked to stay home with one on hospitals are overwhelmed with COVID-19, they were buying the land and in most cases impeding the patient's ability to start treatment.
Unsurprisingly.
A similar paradigm emerge in Europe during the year as strict lockdown measures were imposed in many European countries. We saw the impact from COVID-19 delayed the review of our regulator on regulatory dossier peripheral garceau, thereby impeding our ability to launch our medicines in additional countries outside of Germany.
Patient identification is key and we wish to build a strong based on patients ready to get Entre Garza.
As soon as the Lockdown is lifted.
Looking ahead, we will continue to work toward obtaining reimbursement with regards though in other key European countries, and we'll remain focused on improving our U S and European seals on infrastructure.
[noise] adapt to this new pandemic imposed business environment.
Now before turning to the pipeline, let me touch upon the financing exercise were completed last month.
As announced on January 19, we closed a bought deal offering approximately $46 million.
To help on our R&D activities commercial initiatives and working capital needs as mentioned moments ago, we have identified opportunities to invest in the lifecycle management of our HIV medicines and enhance our marketing initiatives to continue to build our competitive position in the niche HIV markets we serve.
Strengthening our cash position through a D offering helps us to further support our HIV franchise.
Moreover, as we look towards 'twenty 'twenty, one we acknowledged that we're entering a huge inflection point from the company with the initiation of two significant pipeline progress things.
Phase one study in oncology that has the potential to progress quickly and a much larger late stage clinical study in Nash.
The recent offering ensures that we have the adequate resources to initiate our clinical program for a day and disease areas. We firmly believe that our current commercial assets continued to hold tremendous potential in our pipeline programs will prove to be significant drivers for the company going forward.
Through the January offering we are now well positioned to successfully execute on our 'twenty and 'twenty, one business strategy and objectives and build significant value for our shareholders.
Our pipeline is a strategically important part of our value driving objectives, and we are very excited about its prospects.
In oncology as we announced a few weeks ago on where lead times are drug conjugate th 19 on two received fast track designation from the FDA at the single agent for the treatment of all sorts of then positive cancers.
As per the M. DS website. The fast track is a process designed to facilitate development and expedite the review on drugs to treat serious conditions and feel on unmet medical need.
Purpose is to get important new drugs to the patients earlier.
E M D. As fast track designation opens the door to many benefits, including more frequent meetings with the FDA to discuss the drug's development plan.
And ensured collection of appropriate data needed to support drug approval.
More frequent read written communication from the FDA a balance.
And the design of the proposed clinical trial and the use of Biomarkers.
Is it your ability for accelerated approval on priority with you if relevant criteria are met.
And finally, rolling revenue, which means that's a drug company can summit completed sections of the new drug application E. N D day, rather than wait on sale every section of the NDA is completed before the entire application can be with you.
It is particularly remarkable to have a pain and fast track designation for such a broad indication based solely on preclinical data.
To assist with the execution of our phase one clinical trial, we have contracted with a well recognized global Seaworld, we expect to be in a position to deliver results from the dose escalating part of the trial around the end of 2021.
Through our sorts of one positive technology, we believe that we haven't fit for purpose peptide that could change the way cancer is treated.
But as you know this is only one element of our pipeline.
There is also of our Nash program, which we believe may provide another opportunity to bring an innovative treatment to an area of high unmet need.
On January seven we announced that we had received just studying the proceeds that are from the FDA from the phase III clinical trial on more than for the treatment of match.
As per the Fda's recommendation, we have requested a meeting with the agency to discuss the findings on the heart of protocol.
Ensure that we enter phase III development, that's fully in line with your expectations for this trial.
We also plan to discuss with the European authorities to ensure that we can have a common program in both territories.
Our goal remains to initiating the phase III trial in the third quarter of this calendar year.
In addition to our pipeline in development on a multi dose pen injector that will be used within USAID formulation of Assam warning is progressing well, we still expect to file for a supplemental biologics license application in early 'twenty and 'twenty two.
It is clear to me not even taking into account the Nash indication at the Enphase formulation in pneumonia and injector it hasn't potential to change the way physicians look at the management on vegetable fat.
Furthermore, in conjunction with our agreement with I'm on my own objects. We also continued to make progress evaluating and 90 push formulation up from ours and expect this study for that indication to be completed in the third quarter of 2021.
Following that time in I'm, sorry on the acknowledged geez aren't planning to evaluate an intramuscular method of administration, which requires on that study is expected to begin in the first half of 'twenty and 'twenty one.
Our objective in 'twenty 'twenty, we're ambitious and had been met or exceeded on the strategic front two advancing the pipeline and prepare for the future austerity technologists.
Let's now turn to finish for fourth quarter and full 'twenty 'twenty result, Phillip please.
Please go ahead.
Good morning, everyone.
Our last quarter was our best ever and the same holds true for our last fiscal year.
In fiscal 2020, we recorded net sales of $66 $1 million, representing an increase of $4 five per cent from the previous year.
Net revenues for a grifter as they were essentially flat in 2020 compared to 2019.
We recorded $35 $4 million and net revenues from the grip to franchise compared to $35 5 million last year.
As Bertrand Russell annual net revenues were up approximately 11%, reaching $37 million in 2020 compared to 20 772019.
Cost of sales slightly increased reaching $26 9 million.
From 2020 from $26 $1 million a.
The year before.
Cost of sales is a reflection of production costs related to the manufacturing of GMP batches for our oncology platform.
Cost of goods sold on the other hand was Lord Grifter SV carries higher gross margins than the original formulation of a drift up and regards on gross margins increased in the latter part of the year given the achievement of a pre determined net sales milestone about in the third quarter of 2000.
20.
Selling expenses remained fairly stable and were up by approximately $400000, reaching $26 9 million in 2020 compared to $26 $5 million last year.
In 2020, R&D expenses increased to $18 million compared to $10 $8 million on the previous year.
The increase in R&D expenses is largely due to our oncology program.
The development of the FAA formulations, and multi dose injector, our Nash program as well as increased regulatory expenses and medical activities in Europe.
G&A expenses grew to $12 2 million compared to $8 3 million in 2019.
This is a result of the transition to a new CEO the listing of our common shares on NASDAQ and an increase in activities in Europe.
Financial expenses for the year were down slightly to $5 million compared to $5 $1 million last year.
These include the interest payment on our convertible notes.
And the noncash accretion expense of $2 $1 million.
These costs were offset by financing income of $300000.
Great.
In 2020, we recorded a net loss of $22 $7 million or 29 cents per share compared to a net loss of $12 5 million or <unk> 16 per share in 2019.
Operating activities used $13 $6 million of cash in 2020 versus $3 $4 million last year.
Our operations used $7 $3 million, while changes in operating assets and liabilities.
$6 3 million.
While increased receivables and prepaid expenses were mostly offset by accounts payable and accrued liabilities inventory buildup juice point $4 $9 million, mostly due to the buildup of inventory in anticipation of the <unk> launch in Europe.
Are there uses of cash for the year were the payment of interest on our outstanding convertible debenture.
On the payment of a $3 $5 million commercial milestone to time it.
We ended the year in cash and equivalents balance of $28 million.
Given the capital raised in January 2021, our pro forma cash balance as at November 30 of 2020 was approximately 63 and a half million dollars.
Looking at our Q4 numbers total net sales.
Reached $19 1 million compared to $16 4 million for the same quarter last year, representing an increase of $6 16, 5%.
Net sales of a grifter rebounded nicely in Q4 day.
Mount it to $10 $8 million on the last quarter of 2020 compared to $8 7 million for the same quarter last year, representing an increase of 23 per cent.
<unk> sales in Q4 of 2020 were $8 $3 million.
Compared to $7 7 million last year.
Increase of 9%.
Cost of sales in Q4, 2020 was down slightly to $6 $7 million compared to $7 million for the same quarter last year.
The decrease is mostly due to higher gross margins on a steep compared to a drift on as well as a lower transfer price force Ricardo.
As previously mentioned.
R&D expenses increased to $6 8 million from Q4 compared to $3 9 million for the same quarter last year. This increase is largely due to the <unk>.
Element of our oncology platform paid formulation and multi dose pen injector and expenses related to the development of tests Marlin in the treatment of Nash in the general population as well as higher regulatory expenses and medical education initiatives in Europe.
For the three month period ended November 32020, selling expenses were down to $6 5 million.
<unk> to $7 $7 million for the same period last year.
The decrease is mostly associated with a transfer of resources from marketing to medical education activities.
G&A expenses remained stable and stood at $3 $3 million per the.
Last quarter of 2020 compared to basically the same amount in the fourth quarter of last year.
In Q4, 2020, we recorded a $1 4 million net finance costs compared to $1 $3 million last year, but as per.
Finance costs comprise interest on the convertible notes as well as accretion expense.
For the fourth quarter of 2020, we recorded a negative adjusted EBITDA of $1 4 million, which is down from a loss of <unk>.
EBITDA loss of $3 2 million in Q4 of last year the.
The difference is mainly due to higher sales and lower selling expenses, which were partially offset by higher R&D spending.
I'll now turn the call back to Paul for some closing remarks.
I think that based on what we have just discussed it is spirit, just saying that they're on technologies has turned a corner I would even dare to say that Denver technology as of today substantially different than what it was when I joined the company.
In 2020, we have not recorded as much growth as we would have liked and we remain cautious about predicting results in the upcoming months due to the COVID-19.
The vaccination phase should be the beginning of the end for the pandemic. However, it will continue to disrupt normal HCP patient interactions, especially in hospitals and clinics, which are mainly devoted to massive acceleration activities.
We are therefore building for the long run and I'm confident that we have implemented the required measures and taken the necessary steps to give us a stronger competitor to match post COVID-19.
I also think that the progression of our pipeline them last year is nothing short of spectacular.
In just a year and in the midst of a global pandemic, we manage to file two investigational new drug applications received two study May proceed letters and obtain a fast track designation. We're we're sort one policy on my apology platform.
This fast track designation for shortening positive recurrent advanced solid tumors that are refractory to standard therapy is a much brothers starting point than anticipated and provides a good chance to have regular interactions with the FDA.
We're also we also have obtained the study May proceed letter or our phase III program in Nash. We are now entering into final discussions with the agency and should be ready to go by the third Q on this year.
Meanwhile, other key activities are on moving forward that plant that is the development of the IV Bush and intramuscular administration of Truecar, So and it just sounds more or less enphase formulation in a multi dose pen.
All of these are key to our futures.
Moving to January offering, we're now well positioned to successfully execute on our 'twenty 'twenty, one business strategy and objectives and build significant value for our shareholders.
Over the last year, we have from raised the bar to new Heights, Fortunately on technologies and we thank you for being part of our journey.
We will now take questions from analysts.
Okay.
Ladies and gentlemen, if you would like to ask a question at this time. Please press star followed by the number one on your telephone keypad.
And it is star one.
Well pause for just a moment.
Yeah.
You have a question from the line of Edward Nash with Canaccord Genuity.
Hey, good morning, everyone and thanks, so much for taking my call and really appreciate the overview today.
I wanted to I wanted to ask you just a couple of questions on the on the HIV program and then I can I can jump back into the queue if necessary from my other questions, but one of the things you've talked about is the HIV program that you are spending a lot of time have been now for some time to customize those programs on the marketing side.
Two two to basically show Hel and fit into what is currently now real world practice, which I think makes a lot of sense, we're seeing a lot of that happening in design of Nash trials, with which I cover as well and so I think you guys doing this is great.
And is it.
As Youre doing that do you see these changes as staying put and being maintained.
Way they will be in their new form even after COVID-19.
Or will there be kind of will there be a regression to the mean to kind of move back to the traditional.
Marketing and sales efforts that we normally see with a with drugs.
Well thank you.
This is this is a good question and I'm happy to have to respond.
This sort of investment that we're doing now to establish the needs for both <unk> and <unk> will be loans pending changes in investment.
Yeah.
Fundamentally our business responds to medical activities marketing activities and sales activities fundamentally the medical activity takes a little bit more time before producing a return.
Marketing is medium term and sales should be within weeks or months and it's D.
Convergence of all of this that makes it powerful so what we're doing now it was a very comprehensive plan and I am sure that.
The outcome will actually get only better as a function of time as obviously it takes time to have the right T O L. In front of our HIV providers tell your story once twice three times have D cabinet will be following up to closing the sale and Meanwhile, ensuring that the patient is debt.
We'll have more information to own their conditions and ask more powerful questions would be HIV providers. So as I said I think that this is not a short term long.
On a long term plan debt will actually produce superior outcome over a long period of time and quite frankly aside from the pandemic.
She is slowing down some of the activities that we are on a cohort.
No no.
Hum.
Concerns whatsoever.
The market is going to react to.
Our promotional and messaging in the upcoming months and years. Thanks for your question.
That's helpful and one just follow up if I could just start with regard to the triggers a single bolus injection.
It's good to hear that that trial fully enrolled and I know that that time meds, that's under time minutes per view, but with regard to developing I am.
For that is that is that really just a matter of chemistry, we know that that can be done. It was kind of the discussion I had with you guys on customer Ella and when we were moving from the different generations of the F. Two F. RFP that was just a matter of Chemistries is is that the same here. When we know it can be done I just need the time to be able to get that done.
Oh, Yes, Yes go ahead, Jonathan and thank you again for your question. This is more technical loss from <unk>.
It sounds going on yes, absolutely.
You remember, where we are present.
At some day, that's probably about four years ago on net.
<unk> injection and Taiwanese patients than what do we have to do now is to redo it and north American patients at the right. Those are the those which is being approved.
In terms of the source of drugs, it's the exact same thing.
The difference with the IV slow push on stuff, that's concentrated drug product, which is administered to the patient the iam won't be the same thing and that study will be initiated.
As soon as we are.
In the coming weeks with the items.
Okay, and I'm, sorry, well really last question just on HIV. Just can you just make a comment on on any.
The tough conversations you've had or any formal.
Eight the patient and adopters for you know.
They're going to have a sense of urgency to change the triplets of medicines that they are currently using and what we have that they don't have it belong acting one so long acting you know formulation allows you to have a better coverage.
And you know a lot of people say that one of the reason why a multi drug resistance of them or just because of the lack of compliance with you use a VIP medicines youre directionally going.
In the wrong direction and.
We're going to continue to add her on our long acting benefits, which will be translated into the Ivy boy and eventually organization. So again I think that was.
As of your is something that you know we were watching.
Respect competition will fight competition, and I think that as long as the M. D. R segment increases.
We're going to be in good shape I do other work. Thank you I appreciate it.
Once again, ladies and gentlemen, hope you have a question. Please press star one you have a question from the lineup Andre <unk>.
Within a full Martin.
Perfect. So you wanted to ask you what do you think would be your most important countless from the next 12 months.
Well. Thank you for for that question I think that you know getting into.
Cancer, now and having a chance to show the safety associated to Th 19 on too inhuman and also early sign of efficacy is definitely something that.
It will be a catalyst and obviously, we know that we can proceed with Nash study that we have put in front of the food and drug because we received a standard. We proceed but we are reclining the protocol now and every bit as important for the future success of that program, so having a political on it.
<unk>.
<unk> well, Mike is also a key take tablets and on.
Christy on for additional color.
That's mainly also on something up from discussing with the oncology based on our technology.
We.
We bring the Cyclothyme, specifically of the cancer cell and and the animal studies, we haven't seen any neutropenia than in the first the new amendments you know he told me a dose escalation and as soon as we reach level, where we would be on the zone, where despite the fact of all those attacks would be dark six if you don't see entered your opinion on.
<unk> <unk>, it's fine part of that.
As for the efficiency data, we need to wait a bit longer because even if you see something so maybe two or three months before we can confirm the efficacy than what we paying for the oncology end of the summer probably some safety that'd probably sports on the end of the year, some efficacy data, which which should be something that will be on.
An important catalyst for the company.
Thank you that's great. Thank you and just in terms of our housekeeping question briefly.
In terms of SG&A, if you look right roughly at the run right on the fourth.
Quarter should we expect or 2000 Andre Andre This is Betty bouchey here would you speak a little louder because we can barely hear you okay I'll pick up here.
Yeah. It's just just in terms of a housekeeping question do you expect.
C N a for the run rate in the fourth quarter to be the same in 2021 roughly.
Roughly.
Yeah, it should be it should be in line.
There might be a little bit more expenses in Europe in North America. It should it should be on line so okay and.
Also for 2021 do you expect any price increases for a director or <unk>.
And it was like her to predict.
Well, we don't.
That's going to disclose that but you could probably expects up yes. Okay.
Okay. That's great. Thanks for calling from me.
600.
You have a question from the lineup injury Leno with National Bank.
Hi, good morning, and thanks for taking my questions. A couple from your first I'll I'll take that can talk a little bit about a trump card. So.
Europe first how are the sales for what kind of reception are you getting in Germany, and any kind of initial <unk> in a doorway, but also a bit of color on you mentioned I think ill prepared remarks ball on patient identification patrol cars in Europe, and then lastly on that one day posted authority Petrocaribe joke.
And the question on there I mean, you did more of an observational study or are there any endpoints, how long it might take and the costs.
Thanks.
Thank you Andrea so the situation in Europe is unfolding nicely when it comes down with ambushing Depaul give the medicine that we have and if anything.
So the launch on convention that we had in Germany, where we had well over 200 dependence.
The need for <unk> regarding that was clear and what we're doing now because we orange on lockdown situation and that is mindboggling educating imagine a day.
Patients had been identified so we have a number of patients identified we know happening we need to actually get our objective.
And quite frankly on each.
Saying to the folks over there.
Whatever you you can do under the circumstances and hope you have the patience have been identified even and beyond that high high on for the timing as soon as things reopen.
Will be treated and we've obviously have a fair amount of patients treated on deep early access program as efficiently, France, where we have a significant oh Lord on your D. H U so the temporary utilization approval.
And that will continue so we're building.
A number of patients now on that will be getting out tested and getting on to regard low as soon as it reopens.
And.
I can tell you from a scientific point of view I'm very happy with what I here, we have a team of MSL.
Absolutely stunning in Europe are virologist for some of them into different countries, Germany, Spain, France, and what have you. So as per my plan to set up the science.
I am kicking on all the boxes at this time from that point of view.
When it comes true.
When it comes to submission to countries. Some countries are rip over a while back this time by Covid. So it is possible that some of our submissions will be late.
But again, we will pick up the pace.
As possible and we'll try to maximize Meanwhile, before the drivers reimbursed when we called the early access program.
Thank you for your question.
Thank you.
And just to follow up on that on the pulse of orientation study.
I mean, if it's only on a provisional study are are there any and point that you need to hit and how much my could cost.
If you haven't okay, I'm going to ask.
Let's see on to Windsor. This month. Thank you the partner registry in Europe. This as a registry the appointment the requested by the European agencies and the goal is really to look at the law permits I can see the water can be reassured that.
The efficacy of that driver will be maintained a mall from we already have a good day up to 96 weeks out of them.
But they wanted to update on the wall.
That's the bold and it's also safety, but safe television on that destroying is extremely safe.
It's it's really the question.
City is ready to wrap up in Europe.
Thank you Andrea.
As a rule these post marketing surveillance on trial are very positive because he allowing you to build a network of leaders gaol's people interacting with patients another call the building confidence into a new medicine, and that's precisely what we're going to try to leverage.
Great. Thank you very much for the color and one more for me.
Is it possible to provide any any information I mean, if there is anything new on discussions that you might have had with that report this on more leaning Nash.
Kind of are there any point that day purchase between them at the FDA that you're looking to bridge before you started to trial and that's it for me. Thank you.
Let's jump relative further in terms of new no book.
Brandy.
We already have submitted the kind.
Kind of the <unk> interview on where the scientific advisory HIV.
We know their position we know their questions were comfortable and interesting to our questions and that will take place on parallel with our discussion with D. M D to ensure that were common.
Comment simple program.
Midyear for historic of the city in the church.
Okay, great. Thank you very much.
Is there are no additional questions at this time.
I'm sorry, we have a follow up question from Edward net.
Hi, Thanks, if we're sorry, sorry for that I. Appreciate you doing the follow up I just wanted to ask a couple of quick questions just per timeline.
Standpoint, so the the.
Supplemental BLA for the F a pen injector.
On.
Cooking was given when you're looking to submit that we should have potential approval from new hiccups by the end of 22 or early twenty-three at the latest.
And I just wanted to know would you guys be launching that immediately.
For customer Rohan or would you hold on for a little bit since we've just had the the new formulation on the market for not that long so far.
At the moment in terms of the.
Competing to file for the submission of <unk> want to have a one combining both the drugs.
The device on multiple multiple span.
That should be.
We are targeting a an approval probably more towards yes on the second half of 2022.
And the goal will also be to prepare to market for something like this we paying us on mentioned before but this is certainly something that's what should have an impact.
Both of our positions on basis.
And we will be preparing a launch rochester on that because.
So we intend to launch it for indications. We currently have and do just switch have been like what we did the between the F. One and the force of ESV formulation when depend on and the new formulation becomes available we will be using it as soon as it becomes available as part of the night.
But we will actually make a submission for a grifter soon as we can enhance the.
The patient.
Patient experience and we believe that this will be significant.
Yep, no discussions I've had with HIV dogs.
They were they were pleased with the with the going to the to the four but.
Definitely kind of changes the whole game and so I think that's that's great to know you guys will be coming out with that directly and my last question is I know.
It is not currently on my model book, but this year, we are going to start to really get some meat on the bone with regard to the oncology programs and I just wanted to see I know with 19 O. Two that were you are preclinical with melanoma.
You've got Youre looking at multiple solid tumors endometrial ovarian colorectal pancreatic just wanted to understand the differentiation with the conjugate docetaxel an O two and Dachsie widow for what would O four where does <unk> fit in I know, it's earlier stage, but just kind of better understand the.
Sleet landscape of the two programs you have right now.
Well. Thank you that's a good question quite frankly.
Before entering what 19 on or can be used for we haven't to see how far we can go with 19 O two and quite frankly with the fast track net we got entertained low.
Label associated with that 19 on two has whined application. So quite frankly would continue the progression of 19 more and we will potentially design additional anti drug conjugate.
First and foremost we're trying to see the full potential up 19 O two with the overall objective.
Ringing them to the market as fast as possible. So could see on do you want a wagon.
Yeah I know this is it.
What we have to do and maybe the reason is because like in the beginning when we bought the company get very limits is if it gets the date that on O nine.
I guess the date on with 19 at two on the in breast cancer in 19 O four on the Orient answer and this is the way.
But since then with the work that was done at the additional research clear to see that on the ninth to ask that much stronger potential and what we initially or thinking debt as I was saying I think that we have to see to see the entire bench on Thanksgiving, but we will carry on our strategic thinking.
John continues to.
Establish confidence with 19 O four and I'm sure that we'll have.
Co positioning at the range.
That's great. Thank you guys are very much and congratulations on getting a lot of clinical on structural work done in a in a really hard year.
Thank you appreciate it thanks for your support.
And there are no questions at this time.
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Well. Thank you very much on during new additional questions. At this time, we will conclude our call. This morning, I would like to thank everyone for being on the call today on behalf of everyone year at their technologies I wish you a very good day.
Ladies and gentlemen, this does conclude today's conference you May know oh disconnect. Thank you for your participation.
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