Q1 2022 Quotient Ltd Earnings Call
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Good day and welcome to the quotient limited first quarter of fiscal year 2022 financial results Conference call. Today's conference is being recorded at this time I would like to turn the conference over to Peter <unk>. Please.
Please go ahead Sir.
Thank you Cecilia.
Good morning, everyone and welcome to quotient earnings conference call for the quarter ended June 30 of 2021.
Joining me today is Manuel O Mendez, Chief Executive officer of quotient.
Today's conference call is being broadcast live through an audio webcast and the replay of the conference call will be available later today at Www quotient PD Dot com.
During this call quotient will be making forward looking statements, including guidance of protections as the future operating results and expect the development and commercialization timelines.
Because such statements deal with future events actual results may differ materially from those projected in the forward looking statements.
Additional information concerning factors that could cause actual results to differ materially from dosing of the forward looking statements can be found in quotients filings with the use of <unk> Securities and Exchange Commission as well as in this morning's release the.
Forward looking statements, including guidance and projections provided during this call are valid only as of today's date and quotient assumes no obligation to publicly update. These forward looking statements with that I would like to turn the call over to closest Chief Executive Officer Manuel.
Thanks, Peter and good morning, everyone. Thank you for joining US today, we've accomplished a lot in the last couple of months consistent with our last earnings call today, we'll be updating you on 3 pillars the mosaic solution.
The quotient and quotient financial position.
First regarding our mosaic solution, we will provide an update on the Mosaiq transfusion pipeline, which includes 3 modalities immuno hematology serological disease screening and molecular disease screening next we were looking to the continued progress in our mosaic commercial execution as we prepare for our upcoming <unk>.
Launch in Europe.
Additionally, we provide an update on our continuing evaluation of ways to leverage the full capacity of mosaic solution to expand into new market segments.
The second pillar that we would comment on is the expansion of the Alba by quotient customer base product portfolio and geographical coverage and finally, we will provide an update on our third key pillar the strengthening of quotient financial position.
Regarding the transportation market, let's begin with our first mosaic transfusion modality, the mosaic expanded immuno hematology microarray I'm happy to announce that the EU field trials are progressing as expected we wanted to share some preliminary data in advance of the completion of the field trials the detail.
Performance results were published in our press release as of this morning.
The preliminary results are very good the microarray contains all of the key commercial relevance specificities.
Most of the specificities demonstrate performance of 99% or better.
Additionally, we received positive feedback from our customers, who stated that the mosaic time to result, it's much faster than the competition is.
It's very easy to use and requires minimal training. We are pleased to hear that our customers are happy with the mosaic solution.
We expect the CE Mark approval around year end, followed by the commercial launch in the EU and other countries, which accept the CE marking.
In the U S. The immuno hematology field trial activities have commenced protocols have been finalized and accepted by Irb's site specific testing agreements are being completed instruments have been installed and staff has been trained on operating the mosaic system.
Now I would like to update you on our second mosaic modality, the serological disease screening micro arrays, Firstly, let's review the updates on the initial Sds microarray for the U S. The.
The initial Sds field trials in the U S are on track to commence in Q3.
Followed by the submission of the 5.10-K premarket notification around year end.
Secondly, we're encouraged with the progress of the expanded Sds microarray development, where we integrated the tests into the microarray internal performance data results were 99 per cent or better for most test. The R&D team are working on the optimization of the micro array of performance.
Our target is to submit for CE, marking in Q3 of calendar year, 'twenty, 2 and to the U S. D. A F D. A by Q3 Q for calendar year 'twenty 2.
Next our third modality Mosaiq modality, the molecular disease screening microarray continues to progress through development with primers and synthetic target sequence of selected for HIV, 2 hepatitis E and west Nile virus.
Additionally, we established the external partnerships to accelerate the development of the commercial M. D S menu and the system in the assay integration.
Shifting beyond development. Our focus has also been almost say commercial execution of our commercial team and technical teams have been working on the qualification of the expected immuno hematology tenders within the next 2 years.
Within that time, we expect to participate in approximately 25 tenders, which represents approximately 50% of the totaled 21 million of annual donations in the European market currently.
Currently we have 15 customers with firsthand experience on the mosaic solution.
We have made progress with the previously committed 12 mosaic evaluations 5 of which are scheduled to take place by year end.
As an outcome of the evaluations, we expect to be able to participate in tenders, which required evaluations generates scientific data for white papers and build country reference sites.
In addition to these evaluations we expect of her farm. Another 10 workflow of assessments before the year end of the fiscal year. These assessments will not necessarily require the installation of an instrument I will focus on of lean assessment of the lab lab workflow.
Additionally, we have targeted of distribution programming countries, which accept a CE mark approval, we have identified 25 potential distributor relationships across 40 countries with the view to driving market adoption and alternate geographies to our current direct model.
The strong performance of the mosaic solution is documented and soon to be published peer review publication on the mosaic COVID-19 antibody microarray and its comparison to other commercially available high throughput Sars Covid 2 serological assays. The findings are another testament to the value of our mosaic <unk>.
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I'd like to conclude our update on the mosaic solution by providing you with information on how we of leverage mosaics power of flexibility by exploring opportunities in new market segments.
Part of our strategy has always been to develop and commercialize mosaiq beyond transfusion diagnostics.
As the commercial launch in transfusion diagnostics draws closer we invest the time to analyze the market and assess the capabilities of the Mosaiq technology.
The first the most all of used market is the 750 million plasma market that we have referenced in previous communications. This market requires serological and molecular testing.
We were first deploy a mosaic serological disease screening microarray that will essentially be a reduced version of our expanded Sds microarray as such we have decided to include a testing for the plasma market in the upcoming expanded Sds field trials.
Our analysis also shows the Mosaiq technology is well suited for clinical diagnostics.
The 2 areas that we will explore in more detail. The unexpected were addressed first or allergy testing and auto immune diseases based on our assessment of these 2 markets represent of total opportunity of greater than $5 billion and we are we have determined that mosaic is well suited for both clinical areas.
Finally in collaboration with an external party, we have completed a companion diagnostic study to assess the feasibility of mosaiq to help differentiate between vaccine induced syrup positivity and natural zero positivity. The results of the study are very encouraging.
We look forward to providing you with further information on our expansion into new markets in the coming quarters.
Now I'd like to update you on our second key pillar of Alba by quotient are Alba by quotient business generated $9 million in sales and grew 2% over the first quarter of last year the growth of our other business was adversely impacted by the conjectural price decrease of our largest OEM customer and their lower.
Number of shipping cycles in the quarter, we continued to see solid growth potential for our other business I have of evaluated several opportunities. These opportunities include the expansion of the product portfolio. The.
On the expansion of our customer base with the acquisition of new OEM customers and the Green geographical expansion, where we are now in the process of registering the alba by quotient products in additional markets, such as Germany, Switzerland, Spain and other countries.
Finally, our third and final key pillar of that I'd like to update you on the English is quotient financial position at the end of May and early June we issued convertible notes with an aggregate principal amount of $105 million at an attractive interest rate of $4.75 per cent.
These added cash to our balance sheet, which at June 30th 2021 showed $166.7 million in cash and short term investments.
We believe the fact that we are able to raise this amount of with Highbridge 1 of our important long start long term shareholders and other investors demonstrates the confidence of the investor base and our technology.
We are well financed to execute on our plans.
Additionally, we are in discussions to restructure or refinance our existing debt of $133 million with the main purpose to avoid further principal payments coming due before the commercial launch of Mosaiq.
Another action related to our financial flexibility. We are currently reviewing our P&L structure and how we allocate resources as an outcome of this analysis I have initiated actions to optimize our cost structure and reallocate resources as mosaic transitions into the commercial phase we.
We will further elaborate on this measures later in the calendar year.
I would like to comment on the situation around our investments into credit Suisse supply chain funds at the beginning of July we received a further pay out of $5.8 million, which reduced the remaining balance of our investment in those funds to $28.9 billion.
Based on the latest communication from credit Suisse. We extent expect of further pay out in August we continue to remain confident that we should recover the remaining balance with this I would like to turn it back to Peter for the financial update.
Thank you Manuel.
Fiscal first quarter product sales were $9 million, an increase of 1.3% from last year's fourth quarter.
First quarter said, although by quotient sales increased by 2%, while the sales of mosaic of COVID-19 antibody test decreased versus prior year.
Within the Alba by quotient business OEM sales represented 65 per cent of oil product sales and reached $5.9 million a decrease of 5.3% versus prior year.
This decrease is mainly related to a lower number of shipments to 1 large customer in Q1 of FY 'twenty 2 versus prior year.
Direct and distributor sales of $3.1 million increased 20% year over year and represent 35% of product sales.
Sales of the mosaic COVID-19 antibody test decreased versus prior year, driven by a lack of market demand for antibody testing.
In the first quarter gross margin on product sales was 41% an increase of 39% in Q1 of last year. The improvement is in line with the trend observed over the last few quarters and driven by a better sales mix.
In the first quarter, we recorded an operating loss of $22 million compared with $19.7 million last year.
In the quarter operating expense were $25.8 million, an increase of $2.5 million over the prior year.
Research and development expense was $12.5 million, an increase of $1 million year over year.
This increase is related to the start of our expanded IH field trials in Europe, and 2 of write off of R&D raw materials.
General and administrative expense were $10.8 million, an increase of $1.3 million compared to prior year.
Included in G&A is stock compensation expense that increased from 1 million to $1.8 million a year over year do.
The increase in total G&A cost is mainly driven by costs related to leadership changes.
Sales and marketing expense of $2.5 million dollar increased $250000 from the prior years first quarter, reflecting the continued scaling up of the commercial group in view of the launch of our first commercial menu for donor labs.
In the first quarter depreciation of the amortization were $1.4 million versus $2 million 1 year ago.
Depreciation and amortization decreased.
Due to changes in India to estimated the useful economic life of certain operating equipment.
Net other expense was $2.4 million compared with $5.7 million into first quarter of last year net.
Net other expense consisted of interest expense of 600000 dollar to a million dollar expense related to the change in fair value of the convertible loans derivatives and 200000 dollar foreign exchange gain.
Compared to interest expense of price point 9 million dollar and the foreign exchange gain of 200000 dollar in the last year's first quarter.
Interest expense was lower in the first quarter of FY 'twenty 2 due to a decrease in accrued royalties.
The decrease in accrued royalties is due to a shift of expected future revenues towards market outside the U S and Europe.
Our net loss for the quarter was $24.4 million or 24 cents per ordinary share compared with $25.4 million or 32 cents per ordinary share in the prior years for this quarter.
Net cash used in operating activities totaled $32.1 million dollar in the first quarter of fiscal 2022, compared with $24.8 million dollar in the prior year's first quarter.
These numbers include interest payments.
The increase of cash used in operations is primarily driven by changes in the timing of D&O insurance payments on it.
Payments related to changes in senior leadership.
Capital expenditures in the first quarter of fiscal 2021 with $1.4 million compared with 800000 dollar in the prior year.
Spend interest mainly include the purchase of the Mosaiq instrument the manufacturing equipment.
Moving on to the balance sheet available cash and cash equivalents and short term investments at June 32021 were $166.7 million compared to $111.7 million 1 year ago. In addition, we held $8.3 million of restricted cash reserve related to our senior secured loan and rent.
He posted for our Swiss facility.
Our short term investments include investments into 2 credit Suisse supply chain finance funds.
Swiss suspended redemption and the announced liquidation of these funds in March 2021.
Between March and July the company received 3 pay out of the total <unk> remaining investments at June 30 of 2021 was $28.9 million.
These funds continue to be subject to significant devaluations of the uncertainties on the company has taken an impairment charge of $2.3 million in March 2021.
To date, there is no evidence that would lead to a different valuation and all the timing of the mountain of food of payoffs is not clear. We believe we will be able to recover the outstanding funds within fiscal year 2022.
During the first quarter the company issued convertible senior notes for the total aggregate principal amount of $105 million or 100.5 minute dollar of net of cost for the issue of DS notes.
The notes carry for 75% interest and will mature on May 26, 2026, unless converted into equity or redeemed in cash prior to the updates.
The convertible debt is included in our balance sheet under long term debt for a total amount of 73 million dollar well of $29.9 where the dollar are reflected as convertible loans derivatives.
This derivative reflects the value of the call and put option related to potential conversion or voluntary redemption.
The value of the of the derivative will be reassessed quarterly.
In addition, quotient that has an outstanding senior debt for the total amount of $133 million out of which 32 million dollar are classified as current portion of long term debt.
This amount relates to principal payments due in October 2021 in April of 'twenty, 'twenty, 2 respectively as of <unk>.
Previously announced we are in advanced discussions to refinance or restructure this outstanding debt facility.
With our current strong cash position at the expected finalization of the debt restructuring, we're well financed and do not anticipate any liquidity constraints of the foreseeable future.
Accounts receivable totaled $4.5 million dollar the inventory totaled $23.2 million.
Compared to March 31st the accounts receivable decreased by $900000 due to seasonality in sales, while inventories increased by $1.1 million.
The increase in inventory is related to the acquisition of instruments of an increase in raw materials for our conventional reagent business.
Moving to guidance for fiscal 2022, we're maintaining our full year revenue forecast from productivity of Alba by quotient reagents in the range of $35.5 million to $36.500.
No milestones related to other revenues are expected.
For the second quarter of fiscal 2022, we expect sales of Alba by quotient reagents between the $8, 2 and $8.7 million.
We forecast capital expenditures in the range of $5 million to $10 million.
With the exploration of our most of the field trials, we expect cash used in operations of approximately $6.5 million to $7 million. This amount does not include debt service cost or capital expenditures.
No guidance is provided on the operating loss.
We do not expect major revenue derived from mosaiq through the balance of the current fiscal year.
With that let me now turn the call back to them on the west.
Thank you Peter looking forward now I would like to share upcoming plans for the 3 key pillars as I mentioned, a few moments ago, beginning with the mosaic solution and transfusion of pipeline.
The CE, marking field trials of our first mosaic transfusion modality. The expanded immuno hematology microarray are progressing as planned and we expect the initial European regulatory submission to be completed in the third quarter of the current calendar year. We expect the obtained the CE Mark of our expanded immuno hematology microarray.
Around year end.
U S field trials are expected to start in the third quarter of fiscal year 'twenty to 'twenty, 2 with an FDA submission anticipated before fiscal year end.
Regarding our second modality, the serological disease screening microarray, we will commence field trials for the initial Sds 5.10-K submission in Q3 calendar year 2021 and we expect to resubmit to the U S. Initial Sds microarray around year end.
The R&D team will continue to optimize the performance of the expanded Sds microarray.
We expect to start your EU and U S field trials in Q2 calendar year 'twenty 'twenty, 2 with an anticipated European regulatory submission and the F. D. A BLA submission in the third quarter of calendar year 'twenty 'twenty 2.
As mentioned before we plan to include the S. D S plasma of microarray and the expanded Sds field trials.
This will help accelerate the timelines associated with our plasma opportunity.
On the patient side, we are developing the patient microarray. According to the letter of agreement with Ortho and expect our European submission in the third quarter of calendar year 'twenty 'twenty 2.
Regarding the outlook of our third mosaic transfusion modality, the molecular disease screening microarray. We're currently evaluating alternatives for the instrument set up to integrate extraction and amplification as we already have detection.
Shifting now to Mosaiq commercial execution, we will continue to provide customers with insight on how to optimize the workflows with the mosaic solution prior to the first European tenders.
I'd like to conclude with the mosaic solution portion by providing you with all of look into how we plan on leveraging the Mosaiq technology in new market segments. We will continue the of the assessment of the market opportunities and seek additional external partnerships, particularly in companion diagnostics.
Additionally, we will dive deeper into this opportunity and provide an update in our Q2 earnings call in early November.
Moving on to our second key pillar Alba by quotient of the team continues the assessment of opportunities to accelerate sales growth and have identified opportunities to expand our product portfolio and our team is in discussions with potential new OEM customers and we'll continue the registered products in new markets to expand direct business.
And finally to our third key pillar of our financial position, we have the healthy cash position that allows us to have sufficient financial flexibility to execute on our plans. We are confident that we can address our outstanding senior debt notes in the near future, which will further improve our cash runway.
That brings us to the end of our forward looking plans before we conclude I'd like to take a moment to thank Peter for his commitment and contribution to quotient Peter joined US a few a few a year and a half ago and at that time. He has made a significant impact for the business on our company on behalf of of the cushion of family I want to thank Peter for his value contribution of support.
To help drive our company and strategic vision.
We are in the final stages of our CFO search and we hope to be able to share a more detailed update by the end of this quarter as you know Peter will stay with us until the end of the year, but you know I just wanted to take the time to thank him for his contribution and the work we've done so far since Mike since I joined the.
Now I would like to turn it over to Cecilia to open the Q&A session.
Okay.
If you wish to ask a question at this time. Please press star 1 on your telephone keypad. Please ensure the mute function on your telephone of switched off to allow your signal to reach our equipment.
Please press star 1 to ask the question we will take the first question from Josh Jennings from Cowen. Please go ahead.
Hi, This is Eric on for Josh Thanks for taking the question.
Looking at the preliminary EU field trial data that you reported today, which look very strong could you help us understand what the remaining steps are for these results to be finalized is there any risk that the correlation of these antigen identification task of drop in the final analysis.
And then are there any other antigens that could be included in the final ige or expanded IH menu. Thank you.
Yeah. So thanks for the question I appreciate it yeah. So are we next steps is basically where we're gathering more data in the different 3 different sides that we are engaging in our field trials are as we continue to consolidate and generate additional data of course of the results are what will change, but we don't expect them to.
The any major difference with the specificity that we've outlined are there are more specificities of that are that are being evaluated like the reverse grouping and you know antibody screening those will be you know further are analyzed and shared we could not share the data on all of that's where you know a where instead of the.
Gathering additional information on those but also the performance of those is also looking very good. So yes as we continue to do that we will continue to share more information and you know we'll go forward any anything else you want to add Peter.
I think the decent.
Yeah. So yeah. So we talked about the additional specificity. So that's sort of be included so we expect at least you know to have a you know the 18.17 to 18 the specificities in in in our submission.
Okay.
Great and then looking beyond the clinical programs and thinking about future commercial traction if you're able to capture the IH tenders in the coming months, how long do you think it would be for those centers are really able to pick up the utilization of the mosaic to the point that we're seeing meaningful meaningful revenues come through are there any other trainer.
<unk> on the system that we should have in mind as well.
No you know I think look I think it's gonna be a matter of the speed of implementation as they complete the tender process for US we participate and then you know it will be you know trying to accelerate a you know as part of the process. What we have identified is you know of I project manager of let's say that we would.
<unk> as part of those as well as the I T component that we know becomes critical you know for any type of implementation. So having a team ready to support that process are you in a phased approach as we work.
Work collaboratively with customers in that the implementation so no, but we don't foresee again, we don't have a specific timeline. We've we've talked about yeah, we will be going on either the speed of the institution or trying to provide resources to accelerate the adoption of those to go live for much quicker. So.
We're looking at different options to be able to do that.
Yeah.
That's helpful. And then 1 more if I if I may of thank you for sharing all of the detail around the tender process.
Can you help us understand how many blood centers have experienced with mosaiq through the hyper care program adoption of COVID-19 antibody testing and through ongoing evaluation programs or are.
All of these centers of that factored into your comment around 15 customers, who have mosaic experience. We're just trying to get a sense of how many centers represent the lowest hanging fruit for for quotient of once the markets in hand.
Yeah. Those are included in the 15 that we referenced in our in our in my remarks.
So so far and that's basically mainly you know between Europe and the U S.
And certainly our goal is as we move forward with the with the evaluations as I mentioned, the you know of the 12 to complete 5 of those and then we're looking at additional you know workflow analysis, which may or may not include the.
The and instrument installations. So our goal is to get the mosaiq in the hands of our customers because of the feedback that we've received every time is so positive that you know are so we're going to be working with that in the next you know of months to come then to be aggressive in in those devalued.
The sons, or even lean assessments to be able to continue to drive that adoption.
And then the other piece that I would add which may maybe sort of a additional to your question is also as I mentioned in my remarks, we're looking at the distributor models for countries that receive CE, marking a 2 to ensure that the us there are opportunities in in are in those countries.
Once we get CE, marking that you know then we we don't perhaps not even have to participate in tender process, but that could be an interesting opportunity for us going forward as well.
Yeah.
Understood. Thank you.
Okay great.
The stand those inefficiencies then we say hey by the way those inefficiencies can be helped the address by.
Introducing the the mosaic solutions, so it's sort of a way to you know help customers understand how they can be better and then on top of it you know as you justify you know the the mosaic opportunity that you say, okay, well I can help.
Save X percent on your current operations because of this solution. So that not only does it help efficiencies on the way the operate but then on going forward what the mosaic solution can help address.
To justify the the investment they would make on on our on our system on our solution and then even have savings beyond that which I think has been referred to by our friends My predecessor, as a 20% savings in operations, even before in a while the the mosaics solution has been implement so so that's the goal and that versus.
A a and evaluation may not be as deep as the Alina assessment, but in our in our target we would try to see if we can combine both but.
But you know some of the evaluations are part of of tender process, which may or may not include alien Lina assessment, but our goal would be to sort of include that because he will clearly.
Help address some of the efficiencies and effectiveness of that they can gain with our solution.
Okay. That's helpful and you alluded to the overview of the cost structure the teams.
Somewhat preliminary when expected the in the position to from an elaborate on those plans and we'll just exercise the lead to net cost savings or more of of reallocation of the current.
Current spending and where do you see like I guess the the the.
It's a combination of the ultimate I'll hop.
Yeah. Thanks for the question I think that's the company is going to be a combination of both on I'll help Peter comment on that but it's.
I was I was coming in you know, we I started looking of different functional areas of of spend you know how are we spending against benchmarks 1 for on established business like on all of the business at the 1 for are we investing for growth for our mosaics solution and from from that standpoint, we've looked at some potential efficient.
Sees you know that we that we see 1 of their is out relocation opportunities also there's some savings of opportunities. So we're gonna we're looking at both so again I I think it's of it as we transition to commercial phase, there's some things that are pretty obvious.
To us as we look at you know the the the different distribution, but Peter you Wanna comment Yeah, No I think it's indeed, both so it's it's basically just took a step back because of the fresh look at our cost structure, where we allocate all the cost, especially the way I see.
The as the grew as well and then how would we relocate those as we get into commercial and also making sure. You know we continue to properly from the all of the business to make sure. We can support the you know the the future growth there first.
Verses of course investing into the mosaic of opportunity. So a lot of it will be rebalancing, especially the external spent but then also of course, you know, making sure we get more efficient and get better value for the money we spend and then the the the last thing I would add on that is as I look. It also so we need to make sure we deliver on the here and now on the the transfusion.
So that's the of course of the main focus for us on the mosaic solution, but additionally, as I mentioned in my remarks that we believe that some low hanging fruit as that would say on the on the plasma and you know on the clinical market that we need to be able to you know also fund and you know, perhaps even accelerated because.
We think that Ah the mosaic could be a really great solution in some of these clinical areas. As you guys are probably saw in our in the R.
R. A K I think we we released the.
Doctor of Haussmann has joined the starting Monday this past Monday and you know so we're already in discussions on how we can leverage he's expertise in the clinical diagnostics across our business. So I'm not saying that we're going to distract ourselves now and not the liver on transfusion because that's the here and now we are fully committed to do that but I think there's other.
The opportunities that I think as the team we believe we'd be very interesting for us to pursue.
Right and the the last 1 just on the on the U S field trials for the expanded die each.
Menu sounds like you got most of the of pieces in place kind of what's left.
To do before he could start the trial.
Well frankly speaking is now out while we're you know completing the the C E. Mark trials. So we're actually to be honest with Ya. Some runs that we have to do from a matter of fracturing perspective, you know that you know the that that are scheduled in there that's pretty much. It the team is working.
On some smaller tweaks.
The in some of the specificity of that you know we want to be able to do you know a for the U S market, but I think from a clinic a clinical trial or if you'll try perspective all of the things are in place for us to be able to deliver on that so it's a matter of you know you know just shifting some of the resources you know.
There from the sea Mark the field trial to the U S. But you know again nothing should be in the way for us to be able to do that at this point.
Alright, thank you.
And again, we're excited with the look Ah I'm, sorry, I I I wouldn't say, we're very excited with the with the field trial data on the sea Mark again, it's a place that the the the teams are excited because we haven't been there before you know of at the level of.
Of quality of the results. So I think the super encouraging again on everybody's kind of pumped internally for that.
The ceiling on my next question from from Goldman Sachs. Please go ahead.
Thank you and thanks for asking my questions on on Peter I. Appreciate it just first time huh.
Hey, I'm, great just maybe on plasma.
You know you kind of Internet last quarter now, you're you're going to leverage your clinical trials times for that how should we think about the timeline for plasma has just been accelerated a little bit or it's just kind of you know how do you think of the timeline for plasma.
Yeah of course, so I think it will follow so it's been pulled in because I'd say I think previously we've communicated that to be in 2023.
So of as we run them in parallel then you know with our S. T. S for U S. I think it will be more in parallel with with what we have there. So you know in terms of launch so I would say maybe a couple of quarters in let me look at Peter and and the C D.
I mean, we haven't really find out of the determined to the exact time on for the submission. What we said is we could bring it into the STS field trials right and then I think the submission yeah still need to figure out exactly how how we secret stuff, but I think look it looks like it's a couple of quarters in at a minimum on that.
I am pushing for for this 1 site that we have which is gonna be sufficient for us too then.
Take the state and then submit for approval. So again I I would say you know at least 662 quarters of 6 months prior to you know to where what we had originally.
Great. Thanks for maybe.
Maybe more like you like I would say it mimics the the S. T S.
Approval for the U S N C. Marking the same you know so it matches the STS expected approvals of that we see instead of logging. It by you know the those that time.
Okay, that's really helpful.
And then just on on Alba, you mentioned, a couple of things in terms of.
Expand the product portfolio of expanding out of the Geography's. Yeah. I know you were gonna get more details on the cost structure and and but I'm just wondering how.
Those investments in Alba fit into how you're thinking about sort of the future cap allocation within the company.
Yeah. So so what we're saying look of I'll give you some little simple things I mean, we didn't have the product registered in in my opinion key countries.
In Europe, so that the that doesn't take a lot of investment, but we're gonna get a nicer a nice return even outside of Europe, but like there's opportunities you know in Asia that we were not really going after which we are now so that doesn't take a lot because it's it's more tender base. So it's just you know.
Ah margin any of the discussion with you know through a distributor in specific countries. So I think again in terms of port for product portfolio is not a huge investment.
It's just you know we can absorb that within the allocation that we have currently from for you know of R&D and development in the other business. So it's not like the huge investment on the other so I would say for all by its very minor.
Investment if the you know if if any incremental to what we have all of I located there, but it's kind of give us a big return. So it's more on the on those sides that we were coming thing so I.
I I hope that answers your question.
Of the telephone the just the last 1 for me just just given COVID-19 on the resurgence we're seeing how are you factoring this into.
To your plans and obviously, it's incredibly uncertain. So it's hard but just how are you thinking about potential resurgence in covenant of access.
On foreign and as we go into the back half of the year.
Yeah, we don't of lots of right now on that we don't anticipate any impact from COVID-19 into a into the projects is that we have it whether it's on timeline or you know our ability to continue with our past that we've described the the during the skull. So so in terms of business reception, we don't see that today on the country what we.
Seen as the UK or just open studying this past Monday, where you know you don't have to quarantine. So for the first time of them I'm gonna be able to visit our eating Berg side, because I wasn't allowed to go.
So I think of what we've seen is sort of the going the other way what we what we have seen is that you know I think of you you've you've also read it in the news that even people who have been vaccinated you know because of the Delta virus, you know, they're getting infected which you know we had a consult on take that came to visit us experienced that.
So again, we don't foresee anything any major impact to our operations of our business, but we we are keeping a close look on on how that we're gonna be managing that from a company standpoint in our employees of going forward.
Thanks very much.
Yeah.
As a reminder of she'll ask the question. Please pastime 1 leave of not take our next question from some game of Numb from the T. I G Research. Please go ahead.
Hi, Thanks for taking the questions just a few questions for me, maybe starting out with the 25 distribution contract targeting 40 country.
Sorry, finding out what the what.
The address book market the air outside of Europe.
Uh-huh.
Yeah, we have not really communicated on this yet I think again.
The the team is working on that sanji of and we'll be looking at you know the releasing some of these data and in the in the near future.
So you know I'd, rather not comment on that right now, but it but it was what we can for sees that it can be of significant opportunity of both from from an instrument as well as the N V agents standpoint, you know for US too you know of participated in this alternate markets again, we're gonna be providing a little bit more color on revenue targets.
For distribution of book for Europe, and in the coming weeks.
Because I think again, we realize this a little bit hard for for some of you guys out there to plug into your you know sort of projections, so Peter and I have discussed that we need to sort of come out with a little bit more clear what is the revenue expectations of what are the assessments et cetera.
So we'll be sharing a little bit more of that in the future.
Gotcha, and then on the molecular testing site add the apartments for for your establishing would you mind characterizing the types of partners there uhm I need hardly large local I D D player on it.
The.
Kind of curious.
I'd, rather not comment on the hard because you know we have not put out any comments on this I think I'm, sorry, I I I would love to share more but.
I will as soon as we're ready to make it make this public we will.
The idea of here is again, we believe the there are opportunities for us to accelerate on the on the instrument side and where there are opportunities for us to accelerate on the assay development side.
So again, we're gonna be looking at you know the.
And how that's going on and then help the impact our of timelines of then come back with a more detailed communication on that in the future.
Okay, No worries and then lastly on plasma testing and that inclusion in the standard.
The child, Yeah kind of yeah, just to clarify did that just expand the number of samples you are analyzing does it or does it also potentially impact the timeline for extended STS trials and no and from Russia, Yeah, I know it should yeah I know it shouldn't it's just we're adding 1 <unk>.
Right.
1 of additional side that will then generate the data that we need in order to get a plasma claim.
So it should have no bearing or impact on our STS the submission go to field trials other submission for that matter.
So, we'll we'll <unk>, we'll ensure that that doesn't happen again is planned this way anyway.
Gotcha. Thank you so much.
Thank you good to hear from you.
I say are no further questions and they can't this time I would like to check on the call back from Manuel for any additional or closing remarks.
But I just want to thank everyone for joining us today on this call and we look forward to updating you on our progress during.
During the the next part of the earnings call and a great to hear from you have a nice day of guys.
Take care.
Thank you that's book the today's conference call. Thank you for your participation, ladies and gentlemen, you may not just kind of.
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