Q2 2020 OpGen Inc Earnings Call
Greetings and welcome to the object incorporated conference call.
If anyone should require operator assistance during the conference. Please press star zero on your telephone keypad.
It's now my pleasure to introduce your host Megan Paul Investor Relations. Please go ahead.
Welcome to opt in order to about 23 calls.
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During the remarks.
Thank you Megan and thank you everyone for joining us this afternoon.
I would like to start this call by warmly thanking our teams at auction traders in Germany, and ours genetics in Vienna, Austria for demonstrating outstanding commitment dedication and work ethic. Despite the challenges we have all indoor not only professionally but also personally during this pandemic.
All of US here at object to seek to provide world class rapid diagnostics that help address not only the acute medical prices.
I do but also the looming prices up ever growing antimicrobial resistance, which killed 700000 people globally each year.
Option has been able to develop industry, leading rapid diagnostic tests, the bio informatics solutions that help save lives and improve antibiotic stewardship preserving the power of antibiotics as an effective weapons in the fight against antimicrobial resistance.
The second quarter 2020 marks the first kind of a quarter operating ever combined company and our business has grown year over year. During these challenging at unprecedented times.
We have successfully integrated our R&D projects operations, emptiness, allowing us to develop and commercialize industry, leading data driven solutions in infectious disease diagnostics.
As a combined business, we have what we believe it's an exciting portfolio commercial stage at EEI cleared or soon to be clear product in our pipeline.
Our portfolio of CE Mark in vitro diagnostic tests that we sell by a 26 distributors and to 45 countries in Europe, The Middle East Africa Asia Pacific I tried out as well as Latin America.
On today's call will address developments related to the cold I assume can damage.
As the World continues to take steps towards recovery from the first wave a magic and avoiding a second wave as best we can.
Well also review financial highlights from the second quarter and I'm sure you an update our strategic initiatives and pipeline opportunities.
First and foremost I would like to address a continuation of the global covert 19 come back.
While the extreme precautionary measures originally put in place are beginning to subside.
It is important to pause have reviewed publicly that make has continued to affect our business operations.
Hostile environment continues to be very challenging.
However, some elective surgeries are now being scheduled once again.
And various noncovered related clinical studies are beginning to reenroll patient samples and specific regions at hospitals on a case by case basis.
Corresponding with health care professionals has also improved although the focus remains managing the covert 19 kinetic most communication remains purely virtual.
Accordingly, we started to take decisive action and Reprioritizing, our R&D efforts to ensure the long term durability of our business.
We continue to adjust our operations and business practices to capitalize on opportunities to help assist in the fight against the virus.
With that being said, we're excited to have been able to announce on the 13th of July our newest strategic co promotion partnership in the United States and indeed in North America, We're married Silicon Biosystems to market and promote Mary's portfolio October 19 related products.
He also antibody test because that.
The self serve system and look out search circulated endothelial cell kit to our network of infectious disease health care distribution providers and research.
You bet D.A. emergency use authorization is granted in the U.S. This portfolio make eventually include a laboratory real time PCR test open for use on various PCR platforms.
We'll talk potential future after the a emergency use authorization. It may also include <unk> point of care platform, that's difficult 19 with rapid results.
As previously mentioned, we have continued to adjust to augment our combined company product research and development efforts towards mitigating the impact to covert 19 prices.
I'll just subsidiary Curators Gmbh secure access to an additional 5 million euros tranche and nondilutive debt financing for covert 90 related research and development from the European investment Bank.
Subject to certain conditions greatest can draw down the tranche during a nine month period, our E until early April 2021.
And the tranche will have a five year maturity from the time of drawdown and its interest only until there with actual interest payments all deferred into the bullet repayment at maturity.
This tragic also carries an equity incentive from 0.7% <unk>, 4% participating interest.
On the then prevailing market cap adoption to European investment bank at maturity.
Options Viads curator subsidiary in the second quarter continued to supply record PCR test kits developed and CBD marked by a strategic partner <unk> throughout Europe.
At the end customer prices have eroded significantly and transfer prices from third party manufacturers have become less attractive.
We have now develop our own proprietary PCR based Corona virus test kit.
We completed the development of a rapid one hour tasks.
That already includes our proprietary PCR compatible universal life as Barbara called.
And we're looking to see IBT, Mark and then offer to our network of distribution partners in Europe.
We'll continue to provide updates when there is more clarity regarding the available regulatory pathway and potential emergency use authorization and subsequent commercial launch in the United States in the near future.
But at this time no determination has been made yet whether or if so when you would see U.S.M.D.A. emergency use authorization for this product.
Depending on the availability of PCR care gifts that may already have eaten away from the FDA by all Menarini partnership in North America, we may determine whether or not to seek such key way into you asked for our own test kit.
Our skeptics has also made tremendous progress during the second quarter and into the summer.
Iris completed all three phases off the R&D program for its undisclosed global IB de partner.
Added a second technology evaluation agreement with another undisclosed globally to be corporation.
And it is collaboration with sandals.
Through the end of Q2.
Signed up new customers, such as Siemens technology accelerator and the Austrian agency for health and food safety as well as published strong data in collaboration with Johns Hopkins University and the Mayo clinic.
Last quarter, we also announced an investigator initiated collaboration with the Carlin's to Institute in Sweden.
To identify bacterial co infections in patients admitted to the intensive care unit for covert 19 pneumonia, using the unit Barrow H.P. and or authorized ammonia.
Curious have provided Carlin Scott was additional universal analyzer for increased throughput and additional HCAT cartridges to enable tactically first study in which the preliminary data was recently released.
Options you have airway scan Powerpoint ammonia identifies a life threatening bacterial co infections in covert 19 patients in just five hours.
And your live Arrow L.R.E.L.R.T.D.A.O. panels are at EEI cleared in the United States for retro protection of lower respiratory tract infections, such as pneumonia.
As with the European H.B. I pneumonia cartridge. We're also running a cobot 19 co infection testing campaign or in the United States with our Universal L.R.T. and our TBL cartridges.
Furthermore performance of the unit Arrow system was highlighted several posters and abstracts and am might broke 2020 online.
I'll now turn the call overcomes, Tim DAC, who will review financial results for the second quarter of trying to try and recent financial developments So business Jim.
Thank you Oliver on today's call I will touch briefly on the highlights in the second quarter 2020 financial results.
Please keep in mind that the business combination was approved on people first as this year. Therefore Q2 results include first full quarter as a combined company.
The year to date was six month numbers only include three months as a combined company and all references to 2019 pertaining to the option owners.
Any pro forma referenced they'll be noted separately.
Revenue for the second quarter of 2020 was 1.2 million up from $1 million.
A year ago increases largely due to strong collaboration revenue from Aries kinetics as well as international sales from Spiritus offset impart by lower collaboration revenue related to the New York State collaboration agreement.
And lower finished product revenue.
Total revenue for the first half of 2020 was 1.8 million compared with 2 million for the first at the 2019.
As a reminder, we disclosed on our last call that curated annualized revenue for Q1 0.1 was approximately $1 million.
Therefore, our pro forma revenue for the first half the 2020 was approximately $2.8 million.
Operating expenses for.
The combined company for the second quarter 2020 were 7.7 million compared with 3.6 million in the second quarter 2019.
Operating expenses for the first half of 2020 were 12.3 million compared with 8.4 million for the first back in 2019.
Net loss for the second quarter 2020 was 7.5 million were 49 cents per share as compared to 2.6 million or $2, a 94 cents per share in the second quarter 2019.
Net loss for the first half of 2020 was $11.4 million or one dollar per share.
Compared with the net loss of $6.4 million or $9.54 per share the first step 2019.
As we continue to navigate through the Kobin 19 recovery process, we will continue to.
To prioritize the transparency of our business, our pipeline and key financial matters.
However, at this time, we will not be providing any guidance for the company.
I'd like to conclude my prepared remarks by updating everybody wants and positive news.
Over the last few months, we achieve increasing our average volume out of stock with average trading volume in excess of 2 million shares per day.
We believe there are number the reasons for the increase trading activity in our stock.
Such as the completion of our business combination.
The announcement of the co promotional partnership mentoring.
Our efforts to battlefield 19 with collaborators such as many and via other distributor channels.
The continued execution about every strategic partnering programs and corresponding news blow out.
And of course strengthen our balance sheet via both or ATM facility and the exercise of warrants from the October 2019 public offering.
Because of this strong support we have raised approximately $24.2 million in a first 70 plus from onto this year.
We may consider utilizing extent expanded capacity under our ATM facility or other financing alternatives on a selective basis at the appropriate time over the coming months in theaters.
Total current shares outstanding or approximately 719.7 million shares.
As of June 30, 2020, we recorded 12.9 million in cash.
With that I'll turn the call back dollar to discuss additional key milestones.
Thank you Jeff.
I would now like to highlight some of options key development programs and commercial activities.
As stated on our previous call in May of this year, we have submitted to the Acuitas AMR gene panel price. So its five 10-K to the FDA and the second quarter of 2019.
The agency had responded in July of 2019, and again in January or 2020 with excessive questions and what are called for additional information request matters.
Auction has responded and its continuing to respond to the FDA raised additional information request.
We anticipate approaching a clearance to Salem 40, Acuitas AMR gene panel prices in the second half of 2012.
Exact timing cannot be projected due to covert 19 pandemic and subsequent ft a delays.
As a result of looking back the FDA has granted a 90 day extension to all marketing submissions and applications on old as of June 20 trial.
Which resulted in options original submission deadline of July 15th.
Being extended through October 13th of 2020.
Despite the FDA decision to extend the all submissions.
Option will continue to be prepared for speedy communications with the agency showed the timeline change.
Our team is fully prepared and has continued to provide information and data required for the review process immediately upon request.
With regards to our Acuitas marching peril for Europe.
Clinical trials were initiated during the first quarter planning twice.
We currently have nine participating sites growing urine samples for enrollment for the acuity is a more gene panel Europe denovo.
Testing and the trial have been suspended during most of the second quarter of 2020 due to hospitals focusing resources on the go with 19 could that.
However, a number of sites have re initiated enrollment at the end of second quarter.
During the unexpected cause of this trial, we have conducted a comprehensive market survey to inform our future prioritization of programs across our portfolio pipeline assets and platforms and various indication areas, including our bio informatics solutions.
We expect to provide updates on a potential on any potential future changes.
We may make to our pipeline and prioritization of various parts of the business in due course.
Earlier in the year, we announced the completion of the final milestone during the first year of our partnership with the New York State Department of Health and Human Health solutions now part of ITC.
We announced in the second quarter that this partnership has been expanded into a second here to detect track and merit and microbial resistant infections and healthcare institutions statewide.
In response to the gold at 19 kinetic in New York State testing of the program was put on hold by the Watts works better and participating hospitals during the second quarter with fights expecting to begin running tests again in Q3.
We will continue to update shareholders regarding the expected restart date this program where more information is available.
Based on strong validating data published by our genetics and several of its clinical partners such as the Mayo clinic and Johns Hopkins.
As well the excellent progress made in the execution on the partnered R&D programs. We've continued to work very closely with our first undisclosed global leading IBT corporate partner in defining potential next areas of collaboration.
Iris has also added a new undisclosed global IBT company now conducting an evaluation and technical feasibility study of hours DB and recently added Stephens technology accelerator as customer to some of ours Bioinformatic service offerings.
Overall, we're really excited about the upcoming milestones that inflection points in the IRS IBT R&D collaborations.
Just to remind everyone.
Upon completion of all three phases that are partnered R&D project, which has recently occurred there is the potential during the next three month for our partner to exercise an option.
Which upon exercise what brand from a 90 day exclusive negotiation period for certain continued R&D collaboration strategic partnering licensing and commercial rights to the hours database.
In closing, we're very pleased with our results for the second quarter 2020, and head into the third quarter with a strong foundation at a healthy financial position, which has been significantly strengthened during the course Q2 and a year to date.
Although our current global business environment remains uncertain as continued investments in various strategic initiatives, we strongly believe option as well position to meet our our long term product and profitability targets.
Our combined proprietary product portfolio and pipeline includes many exciting prospects such as the pending FDA clearance decision of the exceed what is a more gene panel price looks in the United States.
Along with additional clinical trial and future regulatory milestones such as an expected Chinese regulatory approval alternative arrow and an ammonia test once the Chinese and Mph conclude this review and ancillary Chinese clinical data becomes available.
But above all four truly excited by the multiple strategic partnering and licensing opportunities around the Irish genetics technology platform as well as the unit airway 30 platform.
As always we appreciate your ongoing support and look forward to growing this business together.
I would now like to turn the call back to the operator for questions.
Thank you.
We will now be conducting a question and answer session.
If you would like to ask the question. Please press star one on your telephone keypad.
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Depresses our team he would like to remove your question from the Q.
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One moment please poll for questions.
The first question is from Maxim Jacobs with Edison Group. Please go ahead.
Okay.
A question.
Well I was wondering on a German government investigation and see the merger.
It is offensive like.
What's the worst case scenario that can happen you that.
Investigation.
Sure Maxime.
There will be in Germany, it's kind of a funny one because it is I believe political but so theoretically.
The German government upon review of any M&A transaction of a non European union acquire or acquiring a company here in Germany has the has the right for review such a transaction up to five years interiors.
And could hypothetically, even declare a transactional envoy now for that to happen as a hypothetical worst case it would take a vote of the entire German federal government.
The only time this has ever happened in history is a upon a hostile acquisition by a Chinese company of a nuclear metals.
Company. So what we would normally see is a clearance post hoc basically staying no further concerns.
Given that this is up.
Primarily at least that's our understanding primarily driven by the fact that greatest has a franchise in covert 19 related products.
They could of course require us.
As option to continue providing these products.
On an ongoing basis also to German and European customers, which frankly is our business plan and strategy anyways. So that would be have absolutely no concern, but that's sort of the hypothetical scenario, we do anticipate now Germany coming out on our summer holidays, we would expect a response here over the next couple of weeks.
I will of course update the market as soon as we have that.
Okay and that's extremely helpful.
Putting into context and then.
I was just wondering about just on the.
The many co promotion he just given given the level of sense about.
Your where those products fit into the market like what what's what's their edge.
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Hi, the how is it in the marketed.
Sure sure. So I mean, the first thing I understand the relationship with Menarini globally is a strategic one they are obviously our exclusive distribution partner here in Europe across 11 key markets for our Universal platform and so we recently added to that a strategic partnership the.
Yes.
And Canadian and Mexican co marketing and co promotion.
Aspects to.
This is for a for a portfolio of products. Initially there's two products to sell search platform, which is a mary.
Silicon Biosystems own platform for research use only it's really looking at circulating endothelial cells, which in certain.
Complications of covert patients may play a role that's mostly targeting large academic centers and then the.
The yields an antibody test kit is one of only for FDA emergency use authorized.
The antibody test could fats.
Takes a simple drop a blogs results in 10 minutes.
And basically indicate for both AG and IGPM antibodies, whether you've had a.
Hey, cobot infection, either very recently or over the last several weeks or months, depending on whether its I'd GE or idea.
Very simple to use validated in literally tens of thousands of outpatient specimen.
Hi, quality performance data AR, and AP and one of the key factors and that's also why we're excited about demartini partnership marrying is taken care of all the supply chain issues, so they're they're buying the product and keeping it in stock in inventory at Menarini Silicon biosystems in the U.S. buying it from he'll then in Texas.
Bob in.
Almost unlimited quantity literally they can have access to potentially millions of tasks.
Every every month.
So supply chain shortage will not be an issue performances, great. It's an FDA EU way and the deal that we have with Mary is fairly simple as we announced on the in our July 13th press release, It's a a co marketing co promotion. So it's not a distribution deal.
Adoption, we're not buying any product, we're not stocking any product, we're not actually fulfilling any orders were reaffirming our customers or potential customers to marry Silicon Biovance, then do all of the contracting at order fulfillment invoicing and accounts receivable collecting and we get paid a commission on the net.
Revenue realized by Menarini on Thats referral customers.
Which I think about it from a margin profile that sector mission that we get from at our any would be pure margin as we don't have any cost of goods.
In one called.
That was extremely helpful. And then just my last question one of a macro question.
Yes.
Well, what do you have on where we are in terms of the recovery.
Elective procedures.
[laughter].
I just as good luck.
And first of all these days depends on the country and the GRC here in Europe.
We have seen countries, even hard hit countries, like Italy, or Spain et cetera also here in Germany definitely pick up.
It's it's probably not a lot an extremely stevie it's probably more of a a U shape.
That said, if where for example, looking at to orthopedic procedures.
In the in the U.S. and we've got some inside the rate at one of our partners areas medical who are one of the leaders in orthopedic bone cement.
They seemed a tremendous uptake and gamma on these so you know hip and knee replacement elective surgery. So.
It varies depending on where we're heading here over the summer and into the fall with regards to have a second wave and can we can we get that carved out, but it's actually been surprisingly steep.
Europe coming out of this summer. We are seeing are also non covered related testing volumes and forecast by our distribution partners picking up again.
Our and again us hospitals.
Seem to be opening up for things other than Covance.
Cautiously and it varies state by state.
Generally good good.
Willingness and open up here in the third quarter to start to upstart testing again.
In wonderful.
Thanks again for taking my questions.
We expect.
The next question is from Ben Haynor with a life Global Please go ahead.
Good afternoon gentleman, thanks for taking taking the questions here can you hear me okay.
Perfectly.
Great. So just just looking at the news you had yesterday on on.
The large detection bacterial pathogens in them, our detection work flow with with Ngs.
My understanding is how this work is you don't facility runs the test.
In obviously their own facility.
Ngs takes the output sends it or the areas areas uses the him our prediction AI program since the results back to the the hospital or the facility.
So it's kind of bio informatics is a service am I understanding that correctly.
So youre right I mean, our genetics has basically both the capability to offer exactly what you said SaaS software and service I see anybody who in their own facility runs. The next gen sequencing upload the past few file into the hours cloud and then basically the Rx team using.
The prediction algorithms will interpret the data and returned the results. We do also have a.
A service lab, Indiana. So we're also receiving specimen where ours genetics actually performs the next gen sequencing in the wet lab.
And then basically goes through the the artificial intelligence powered prediction algorithms and bio informatics. So we can do both.
For example, in our strategic R&D partnership with that large global IBT corporate.
Yes, genetics and conducted.
All of the wet lab work so they were actually send specimen.
Fantastic.
The specific press release, you referred to indeed part of the Cajun collaboration.
Where that was more of a software as a service, but they also ramped that we we have a full qiagen sample prep set up and again access to next Gen sequencing, Indiana, so either as possible and depending on the preference off the collaboration partner ours is so happy to offer offer either Mayo clinic again.
Some of the publication.
That's out there Mayo did all of their own Ngs and just to offload the data and ours did the data interpretation.
Okay. Good I mean, it sounds like you like quite the slick solution and I know others that have looked to that kind of doing something similar with a guy and I looked at some of the papers referenced in the the paper published on the results that you guys were able to get it didn't seem like anyone who is coming closer.
Terms, so the levels sensitivity specificity.
Are you seeing anyone else out there getting close to the numbers that you've been able to achieve in a in the city the unit.
The work you've done I mean, we certainly we certainly believe that are as has some of the bad validated.
Eight out there in terms of really full clinical data.
It peer reviewed and published so definitely a head start out. We also of course see a number of file rather well funded next gen sequencing players.
You have coming by carriers doing doing service.
Our CLIA lab.
By DNA, a couple of others. So.
Clearly this is getting better but I think there's some genetics is the first.
First time has been able to demonstrate that it's not only possible to detect or predict resistance antibiotics.
Mark reduction, but really train these AI algorithms and identified a number.
A feature sufficient to predict antibiotic susceptibility.
I think about it that's what you really want you want to tell the doctor at the end of the day look this blog.
Given this next gen sequencing information at all if the data we have in the in this curated rsvb.
Suggest that this spot is still susceptible therefore use drug a b or C.
That's also what our strategic collaboration is about really for a specific set off.
Certain box with certain antibiotic drugs.
So look at.
Literally thousands of data points.
That you puree doesn't build into the database and the bigger your data set yet for any of these southpark drug combinations to better these prediction algorithms to top.
So we're definitely excited we believe we have a head start.
Again, I know, it's going to be key to continue working with partners. Both academic clinical but also corporate sub to continue building out that database and make an error with every backdrop combination that's being up being analyzed.
Excellent doesn't that's great color there and then.
No. It's only been a couple days since the release and then I guess, so weve found out today that you've got a second undisclosed global IBT Corporation now that you're working with.
Have you have you seen.
Additional incoming interest straw.
And now that the data is out there.
Yeah. There do you have there is definitely a great interest now it's also fair to say, though that the universe all.
Okay large in vitro diagnostic corporations in the classical microbiology space is a finite number.
Right so.
Everybody who's not probably one of the two parties also knows that it's not them.
But yes, we've definitely seen at that was also what happened with the second parties are based on some of the early announcements with our first partnership has definitely triggered some inbound interest and we continue to keep open dialogue, but again with.
With that so first partnership we're really at a point, where all of the work and this was completely not affected not not by a single day not one iota by Covis. So the team, Indiana continued powering through all of that executed on time.
Deliberate the final report here.
In July all three phases completed which now thats. The some three month clock for the potential to exercise that option and that of course.
What I just want to reiterate it is an option once exercised that gives the party.
90 days of exclusive negotiation, it's not a first right of refusal there was no pre agreed commercial or economic terms. So obviously it could be a very interesting triggering point given that there is additional parties in the makes looking at the technology and doing their own feasibility work.
Okay, Great and then as I guess, it's kind of becoming a guess who game of guests who it's not just given the define a number of these guys out there I guess.
Lastly from me I guess is once more for Tim I know you said, you're not going to offer guidance, but you know just looking at the combined companies income statement and <unk> exempting the transaction costs that you saw in in Q2.
There are any special consideration. So we should be thinking about you know to the changes in for changes in the various line items of Opex going forward.
Well I think the best way to answer that question is in and I've said this in the past.
We did file pro forma statements.
If you go back and look at the numbers last year and compare them to the spend in this quarter in just multiply by four annualized the numbers are actually lower than the pro forma and there's really lower for a couple of reasons.
So im not giving specific guidance I would say if you look at the three main line items between.
R&D.
You'll see that the number annualized is probably about three or $4 million less than the spend the year before.
You touched on that in my remarks, the reason the clinical trials associated with the earn had been put on hold.
So you can kind of do your own estimate of what those costs would be and try to see if they'd be in the back half of the year.
So thats easy do DNA pretty straight forward. If you look good the pro Formas before and look at what we spend this quarter you don't have to do much work and then from the sales and marketing perspective.
You'll see that the numbers were significantly higher last year.
And of course that makes sense in terms of where we are in terms of travel restrictions opportunity to get in front of customers and such so.
I would suggest that it has a alluding to here I would take a look at that time, we had in and looked at though.
We did today or acute and you get pretty close to the numbers.
Okay got it that's very helpful. Thanks, a lot for taking the questions gentlemen, the plan.
Thanks.
Your next question is from Yi Chen with H.C. Wainwright. Please go ahead.
Hi, Thank you for taking my questions.
It is with any part of the.
Second quarter revenue, the maybe two coconut team.
Yes.
Okay. So I right into it in my remarks, we we did continue to.
Distribute.
BG I used cars Colby to PCR kits in Europe.
And so that did contribute.
To the international revenue.
If the question is did any revenue it onto them at our any partnership contribute the answer is no because we only close that deal on July 13th So that is not part of any Q2 numbers.
John.
So in could you give us more color.
Commercial and solution approach for the new recipes.
Sounds koby to PC returns capability and we choose.
When it gets the studio city, Mark in how each of whom to.
Managed.
Just to be June products.
So as BJ, that's fairly simple as as I alluded to scale up with.
A third parties, such as VDI and many others over over the last couple of months. So on the one that increasing their transfer prices.
To their distribution partners and at the same time market prices coming down substantially here in Europe for the sub PCR kits.
We will be replacing the BG kits from a from a commercial distribution side with our own Sars Koby toolkit simply because the margin profile is going to be here.
A multiple of.
Better why you to call a lot lower than buying BG kits plus as I said, our test is a one hour time to results test kit.
The BG test kits or is a roughly two and a half hour time to results kit, so significantly faster significantly cheaper significantly better margins.
Performance, we'll see the data when the final verification validation data is out.
Yeah, we're certainly confident that.
The product that we've developed from a our assay development team is going to.
At least meets if not surpass.
Performance, but again that data once out we will communicate and then once the market strategically will do exactly what we did with the with the VDI kit, namely use our European distribution network.
Across different markets.
Now can be.
Can be eastern Europe can be across a core European markets.
Can be internationally, where ever CE, Mark is accepted as a regulatory clearance.
So far just reiterate we have not made a determination or decision whether or if so when we may also seat FDA you way.
Jimmy you less because again, we may find ourselves in a position that.
Under the main our partnership.
And if you look at them at our AG Global website, you'll find a full portfolio of various coal was 19 related assets.
We don't exactly know which of these will get FDA emergency use authorization at when by deepened when they do they would become available to us under the Menarini commercial co promotion partnership.
Thats also what we said in our press release up back in July.
Therefore, if there were a PCR kit that has already received SKU way.
We may prefer that over going through the whole eway process followme product, but to be determined.
As of yet unclear.
But just to follow up met a renewed till the 19.
PCR products due to require only on a construction.
Were they do not.
My understanding is that the ones they have at least that I've seen year Europe.
They do but we also law.
Believes that they have certain programs and again that desktop so far so far the ones that they have require and on a trap.
And our kit will work either with or without denominate crap, depending on what your input materials goaltender dry swap straight you can go use Paul will then go straight into the PCR.
But if you had something that's being heavily diluted et cetera, you could just as well use any any write off the mill aren't a prep kit.
You'd still have the advantage of having a one hour time to result, PCR as opposed to some of the ones that on the market that are more to it out some of them in three hours.
Got it.
Thank goodness.
We used 58 has recently established too close to four.
We're going to maintain screening test used own population that do not have symptoms or are not expected to have put them into infection and so far I think there's only one test who that's for Labcorp, who previously would be issued.
Now begun we issue can you in squint purposes. So I'm just wondering what is he and the opinion on koby maintains screening test for asymptomatic.
And what is options approach to that.
The net population as people returned to more places and schools.
When you say DNA or you talked about the European Medical Association.
Yeah.
That will be well because they're not involved so technically there is no approval required by the M&A or any other.
Governmental or supranational body in Europe.
It's still in the fortunate situation that so all of these products, our CE, Mark which basically means the upon signing a declaration of conformity, it's a self certification.
What we're certainly seeing right now.
Literally these days and weeks here, and Germany, and Europe people coming back from summer holidays, a case numbers going back up there is tremendous pressure on testing.
Here are the local state just decided that every teacher from kindergarten through high school is entitled to having two tests done over the months of August and September So there's going to be tremendous pressure on getting has done.
So there is so far at least here in Europe, we're not seeing any restrictions in terms of certain.
Evidenced that that you need to.
To to have four for at least a regulatory clearance.
And the question is are you really going for screening as a screening claim or you are really.
Thinking of it more as a diagnostic test.
And then again, if you look at our products both.
The BG kit as well as our own PCR kit.
This is no option.
Aimed at fees Ultra high throughput.
Mass screening platform, we think of something like a Roche cobas platform or others, where you are you doing and the thousands hundreds of thousands against a highly automated central App, we're talking about.
That run on standard real time PCR platforms 96, well played so you do 96 test at a time.
Minus probably two for you control.
So it's for moderate throughput.
And you know hundreds or maybe a few thousands of tests per per instrument. So prolapse there.
So getting after looking at mass screening there are other approaches and other platforms that are probably better suited.
Got it thank you very much.
Good thing.
There are no further questions at this time I would like to turn the floor back over the mystery shop for any closing remarks.
Well, thanks, everyone for joining us today, and we look forward to updating you as we continue to progress the business for more information. Please visit the investor section of our website or our SEC filings and feel free to give Tim or myself a call. Thank you very much and have great day.
This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.
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