Q1 2020 Earnings Call
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Ladies and gentlemen, please standby your conference well begin shortly I feel that time, the lights will again be placed in home. Thank you for your patience.
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It could be you may begin.
Thank you.
Welcome to the opt in first quarter 2020 earnings call and business update.
At this time, all participants are in listen only mode.
Following management's prepared remarks.
Yes, you want a session.
As a reminder, this conference is being recorded today may stabbing twentytwenty.
Before we begin I would like to caution you.
Comments made during this conference call my management that contain forward looking statements.
Regarding the operations up and future results.
Option, including a subsidiary curious.
I encourage you should review options filings with Securities and Exchange Commission, including without limitation.
The company's most recent form 10-K.
Form 10-Q for the first quarter of 2020, we filed with the FTC, which identify specific factors that may cause actual results or events to differ materially from those described in the forward a forward looking statements.
Factors that may affect the company's results include but are not limited to our ability to successfully achieved the expected synergies companies completed this combination with curated.
And to implement that combined company Scott.
The impact of the current global Cobot 90 pandemic on our business in operations, our use of proceeds from the Aki market offering that we commence in February 2020 as was the proceeds recent warrant warrant exercise.
Pursuit of Becky clearance of the Acuitas Air marching panel for use with bacterial islip.
For our other parts and services.
Right, but talking about parts and services for hospitals and other health care providers in general as well in the current cobot 19 pandemic situation to predict particular.
The success of our commercialization efforts and partnering strategy you effect on our business of its existing and new regulatory requirements and other economic and competitive factors.
The content for this conference call contains time sensitive information that is accurate only as a deal does live call May 720 20.
Company undertakes no obligation to revise or update any statements to reflect events or circumstances. After the date at this conference call, except as required by law.
Joining the call today will be Oliver shot president and CEO and Tim deck default option.
I would now like to turn the call over to Oliver shock. The recently appointed CEO of option. Following the completion of the business combination was curious.
Oliver.
Thank you Joe and thank you everyone for joining us this afternoon.
It's a pleasure for me on my first earnings call is the new CEO of option to share with you the vision and mission that we all share here at the newly combined company, including our teams that curators in Germany, and ours genetics in Vienna, Austria.
All of US here at auction Sri vision to successfully addressed the looming crisis of ever growing at a microbial resistance or anymore.
Our mission is to develop rapid diagnostic tests as well as bio informatics solutions that help to rapidly identify pathogens anthem resistance marker profiles in hospitalized patients with severe life threatening infectious diseases, such as pneumonia urinary tract infections and other indications.
Such rapid testing will help doctors select the best and most appropriate antibiotic therapy.
Hope save lives and improve everybody like stewardship, that's preserving antibiotics as an effective weapon and to fight against kind of my crop of resistance.
This is really what is meant by applying precision medicine principles to the infectious disease setting.
To that end our strategy here at option is to deploy our PCR platforms, such as unit Faro and Acuitas as well as our lighthouse knowledge base at all for services some strategic partnering opportunities for our next generation sequencing for Ngs based RCB database and artificial intelligence powered prediction algorithm.
As a combined business, we have an exciting portfolio of commercial stage ft. It cleared or soon to be clear.
Products in our pipeline.
A broad portfolio CE marked in vitro diagnostic tests that we sell by 18 distributors into 43 countries in Europe, The Middle East Africa Asia Pacific in China, as well as Latin America.
On today's call. We will also discuss recent developments regarding the global Cobot 19 can damage to review the combined company pipeline and provide a brief overview of options first quarter 2020 financial results.
On April 1st 2020, following strong shareholder support on both the option accuray to sites, we transformed the business three highly strategic and synergistic transaction.
The company announced the completion of the business combination between option and greatest.
Highlighting a new leadership team and board of directors.
Combined companies complimentary platforms and highly relevant products are designed to help to rapidly diagnosed and fight life threatening infectious diseases.
This broad portfolio undoubtedly supports an attractive combination of revenue growth opportunities.
Reaching future profitability and achieving scale.
We anticipate tremendous value, creating opportunities for the combined company both in the near term, but also medium and long term.
We look forward to reporting combined company financial results for the second quarter of 2020 and thereafter.
Before diving into the business updates I would like to address the continuation of the global Cobot 19 pandemic and how it has impacted our business this quarter.
Government regulations and directives continue to disrupt the status quo with shelter in place orders closing of national borders and the extensions of travel restrictions.
The hospital environment continues to be extremely challenging as the majority of elective surgeries have been canceled and clinical studies put on hold.
In this environment it has become increasingly difficult to speak with health care professionals regarding matters unrelated to managing the cold with 19 condemning.
Accordingly, we have continued to adjust our operations and business practices to capitalize on opportunities to help assistant to fight against the virus.
Have prioritized the health and safety of all auction employees.
Fortunately the fundamentals and drivers of our core business remains strong.
As mentioned on our call in March the Cobot 19 pandemic further highlights the obvious need for infectious disease precision medicine solutions, such as rapid DNA and ornate testing.
To address this need we've adjusted and augmented our combined company product development efforts towards mitigating the impact of the covert 19 crisis.
Option via its greatest subsidiary continues to supply rapid PCR test kits developed in CBD marked by its strategic partner BG throughout Europe.
The first shipments of kits by be Jibril received in mid March and since then cure rates has sold more than 15000 tests of the BG <unk> Koby two product via its distribution network in EMEA.
We're excited to announce that in addition to the distribution of BTI test kits, we've developed our own proprietary PCR based koby to test.
We're currently finalizing development and are looking at the various regulatory pathways available in Europe and in the United States.
We'll continue to provide updates when there was more clarity regarding the approval pathways and potential commercial launch timelines in the near future.
Additionally, we recently announced the start of an investigator initiated collaboration with the Carlin Sky Institute in Sweden.
Identify bacterial co infections in patients admitted to the intensive care unit for Covance 19, pneumonia, using the universal HP and were hospitalized pneumonia Pal.
Greatest has provided karolinska with additional unit arrow analyzers for increased throughput.
And additional HP and cartridges to enable testing these critical specimens.
And the study is already well underway.
This is a crucial study has high risk cobot 19 patients, especially in intensive care units and on ventilation many of whom have pre existing conditions are at a much higher risk of acquiring bacterial co infections.
We expect to see initial results in the coming weeks and we will provide an update as soon as results are available for publication.
In December of 2019.
Just had received FDA clearance for an expanded label claim for our unit there were lower respiratory panel to include the use of Bronco, they'll all of our specimen or email and testing for pneumocystis.
In addition to a broad range of bacterial pathogens antibiotic resistance markers.
This makes the unit Barrow LR cheap Yale test uniquely differentiated as the first and only FDA cleared test, which includes this key pathogen relevant, especially in immunocompromised patients.
The new B.L. indication substantially increases the total addressable market for the universe system in the United States.
As with the European Hps pneumonia cartridge, we're running a cope with 19 co infection testing campaign here in the United States with our Universal LR tea and our T. Bell cartridges.
The overall business outlook for this exciting new product has been transformed.
Hospitals, and health systems addressing the immediate covert 19 crisis or focusing entirely on this matter.
New Univ Arrow system installations at many new plant evaluations have being pushed out to otherwise free hospital in laboratory resources.
That said, we have recently installed new Youtube Arrow analyzers at a chain of labs in the northeast if the United States for running some of our additional portfolio of universal cartridges for urinary tract infections on the research use only lately.
We've also recently successfully completed the first you whats installations of unit Vero linked to hospital lab information systems in the first quarter.
Conversely, with the number of hospitalized cobot 19 patients in intensive care units globally, many of them in ventilators at with the rise in bacterial pneumonia, they likely complication and co morbidity.
One of Arrow lower respiratory tract test could become an important tool for hospitals treating the many acutely ill patients.
Recent new installations in Europe have continued.
Accomplished by a virtual online training and installation support sessions held directly with end customers of some of our distribution partners.
The ease of use an intuitive workflow of the universe system lend themselves to such virtual setup hands on times, approximately two minutes and remote training as a viable alternative.
I'll now turn the call over to Tim deck, who will review financial results for the first quarter 2020, and recent financial developments for business.
Yeah.
Thank you all are.
Revenue for the first quarter of 2020.
Gen. Standalone was 617000 down from 1 million in the prior year period.
The decrease was primarily due to lower collaboration revenue from our New York State contract has revenue from the final milestone was lower than that of the first quarter 2019.
As well as a reduction in our legacy fish revenue.
Additionally, curious in Aries revenue for the first quarter of 2020 was approximately $900000.
Generating pro forma combined unaudited revenue for the quarter of over 1.5 million.
Since the business combination did not occur until April one 2020 is important to note that the 900000 of pro forma revenue generated by fear I guess in areas in the first quarter will be excluded from our year end reported revenue totals for 2020.
Operating expenses for option Standalone for the first quarter of 2020 were 4.6 million compared with 4.8 million in the first quarter 2019.
Included in the 4.6 million in the first quarter of 2020.
Were approximately $200000 of transaction cost associated with the business combination.
And $750000 associated within impairment charge for intangible assets related to our legacy fish business.
Net loss for option Standalone for the first quarter 2020 was $3.9 million or 53 cents per share as compared to 3.9 million or $8.25 per share in the first quarter of 2019.
As we navigate during and through the covert 19 pandemic, we will continue to prioritize the transparency of our business pipeline and key financial metrics.
We will not be providing revenue or any other guidance today.
However, I will say that during this unique John we have been reviewing the operational expense structure and cash burn of the combined company and expect to provide a more detailed and updated outlook in the coming months as the business climate evolves.
I'd like to prepare conclude my prepared remarks by updating everyone on our cash position.
Over the last few months, we have seen tremendous volume in our stock with average daily trading volumes of roughly 2.4 million shares per day.
This bump was has primarily been due to the completion of our business combination and our efforts to battle. The co bid 19 through our collaborations with BG and others.
Because of the strong support we have raised approximately $15 million since mid February through early may.
Both from our ATM facility.
Exercises of the $2 per share warrants issued in October 2019 public offering.
We will continue to utilize the AC ATM facility or other financing all to alternatives on a selective basis at the appropriate time over the coming months in quarters.
Total current shares outstanding are approximately 15 million shares.
As of March 30, Onest 2020, we reported 11.5 million in cash combined with a 900000 of cash from greatest our pro forma cash at March 30, Onest 2020 would have been $12.4 million.
With that I'll turn the call back to Oliver to discuss additional key milestones.
Thank you Tim.
I would now like to highlight some of options key development programs and commercial activities.
Last may we submitted the Acuitas am our gene panel price lets five 10-K to the FDA.
The agency responded in July of 2019 with extensive questions and what is called an additional information request letter.
In early January 2020, we submitted formal responses to a majority of the agencies questions. After which we received additional questions from the FDA in mid January.
Through the first quarter, we've responded to all questions posed by the agency and we'll continue to work address any final remaining open items with the FDA through the interactive review process.
While we believe the review process now nearing completion, we have been experiencing modest delays and the remaining review timeline attributable to the cobot 19 pandemic. Consequently, the exact timing to obtain a clearance decision for the Acuitas AMR gene panel price lets as a diagnostic test is currently unknown.
However, given the time bound constraints of the FDA review process. We continue to expect a near term FDA clearance decision in the coming months.
As mentioned on our previous earnings call in March this year, we had all nine centers accruing urine samples for enrollment for the Acuitas AMR gene panel in Europe Denovo.
We had anticipated the completion of this clinical trial by mid spring.
However, due to the ongoing covert 19 pandemic, our clinical trial sites notified us that they have suspended clinical trial activities until further notice.
We currently estimate that this program freeze put last until early summer as the clinical laboratory sites focused on efforts to support the code would find team condemning.
We're making full use of this unexpected pause if the trial by conducting a comprehensive market survey and primary market research to inform our future prioritization of programs across all of the portfolio of pipeline assets and platforms. The combined company in various indication areas, including our bio informatics solutions.
Additionally, progress has slowed with the New York State Digital Health initiative.
Option had successfully completed all plant milestones in collaboration with the New York State Department of Health and the Loom Health solutions.
Develop a state of the art research program to detect track and manage and micro resistant infections that healthcare institutions statewide.
In response to the code 19 emergency in New York State.
Testing of the program has been put on hold by the Wadsworth fair and participating hospitals.
We've also successfully completed the final milestone for the first year, if the contract in the first quarter.
And although progress has slowed there was a clear expectations by all stakeholders. The project would continue into a second here.
Negotiations and discussions between the collaboration parties are currently ongoing and we will provide an update as soon as available.
With regards to the subsidiary ours genetics, we recently announced the publication of a feasibility study recognizing the potential antibiotic susceptibility testing and bacterial pathogens identification using next generation sequencing were ngs.
The study has been pretty published in the journal of clinical microbiology.
The article is titled species identification and antibiotic resistance prediction by analysis of whole genome sequence data using RCB.
An analysis of isolates from the universal lower respiratory tract infection trial.
And reports on a study evaluating the performance of pathogen identification antibiotic susceptibility testing based on a whole genome DNA sequencing using the ours genetics artificial intelligence powered cloud based bio informatics platform Arse genetics dark cloud.
And its underlying reference database ours TB.
Based on the strong validating data.
We have seen tremendous interest from our current IBT corporate partner as well as inbound interest from potential new collaboration partners.
Overall, we're really excited about the upcoming milestone an inflection points in the Rs IBT R&D collaboration.
Just to remind everybody upon completion of the R&D project phase, which we expect to occur in the third quarter of 2020.
There was the potential for our partner to exercise an option for a 90 day excuse if negotiation period for certain partnering licensing and commercial rights to the hours DB.
While we continue to face sporadic challenges with supply chain disruptions travel restrictions and stay at home policies were confident in the opportunities that lie ahead for the newly combined company.
Near term at FDA clearance decision.
Strategic partnering and licensing opportunities and the upcoming launch of the Acuitas AMR gene panel for isolates in the United States, along with additional clinical trial and future regulatory milestones.
Such as an expected Chinese approval of Univ Arrow, and and ammonia test make for a very exciting stream of upcoming news flow and value inflection points.
Our combined company platform is extremely agile flexible and has elements in place to rapidly identified develop and create novel test formats needed to address potential future infectious disease outbreaks.
In recent weeks, we've made tremendous progress on the business integration post closing of the transaction between option in curators.
Our us commercial sales and marketing team has been integrated and a curated team members have joined option Inc. employees effective may onest.
The team is integrating all customer leads and funnel across all products from unit Vero to fish to Acuitas and bio informatics into a joint CRM system.
The European fish business transfer from option I guess in Denmark, two curators and Germany is on track for Q2, after which the option asked facility will be closed out.
The R&D and operations teams are running at full portfolio review and strategic prioritization assessment based on the aforementioned market sounding exercise and we expect to provide updates on portfolio decisions and synergies in the weeks and months ahead.
Our regulatory teams on both sides are making big strides towards integration of the company's quality management systems and regulatory procedures.
The finance it happened teams are working tirelessly, bringing I T systems tools and processes together under one common option group philosophy.
There's a lot of excitement in the organization and people are seeing plenty of opportunities to grow the business and grow professionally and a much stronger and streamlined combined business.
In closing, we're very pleased with all results for the first quarter of 2020 in light of the global condemning we appreciate your ongoing support as we navigate through these turbulent get equally exciting times I.
I would now like to turn the call back to the operator for questions.
Thank you well now begin the question answer session. If you do have a question. Please press star one now to be placed into Q.
Authorization clearance.
We are in a number of strategic collaboration licensing and partnering discussions around that platform.
And so to the extent that any potential future third party partner might look at it at putting certain menu that might warrant emergency use authorization on it that could certainly accelerate things. It's also currently part of a number of potential Nondilutive grant funding opportunities that were explore.
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Again that might accelerate development time lines, but to be perfectly honest that platform in order to get it. So it's full industrial look and feel and be ready for prime time is going to be probably in in 2021, rather than this year.
Thanks for the the update their <unk> Leslie for me on the on the greatest business and I guess particular in the the areas side.
Can you talk about the the visibility there that you have the the the book genes and you know how any sense of how quickly someone that revenue might be <unk> <unk> <unk> recognizes you at work off some of that business business that you've already booked.
Yeah, well so the the on the hours genetics, it's fairly straightforward right now I mean, we announced the the <unk> corporate partnership but in September of 2019.
We did announce at the time that that is a 10 month R. and D. program, that's fully pre funded by the corporate partner.
The partner also pre paid for the option.
So that what we're seeing in the first quarter. If this year and into Q2 and Q3. This year is effectively revenue recognition onto that collaboration.
Collaboration is fully on track, we've not miss the beep. So the team in Vienna is executing and delivering every step of the way. So we anticipate that program to not be adversely affected in any way from the covert crisis. Despite all to stay at home. That's the good thing about bio and from addicts, you can actually do a lot of things from from a home office as.
Well.
So again that is a program that should complete it's development phase and the third quarter.
And that's the the timeframe at which we would anticipate.
Having a more strategic discussion with a partner again, they can once they exercise that option. They haven't 90 day of exclusive negotiation, it's not a first right of refusal it's not a pre determined set of economic terms. So it's basically talking exclusively with them about a certain license scope.
And access to the R.S. database and the bioinformatics tools and so right now I'd say, we're very very nice spot revenue recognition is going to continue throughout <unk> three and then we're teeing it up for hopefully a broader more engaged more involved and and economically extremely.
Attractive partnering opportunity in the in the latter part of this year.
Excellent that's very helpful and hopefully the extremely attractive opportunity bears fruit.
For taking the questions gentlemen.
I spent.
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For a ticket my question Oh could you come and.
Insisting the size of the potential market for appeal to see emerging panel you're incentive to versus isolation, because if there's any.
And also what's your commercialization strategy going forward for these for the kids a string panels, particularly funny considering that.
19, condemn it could be with us potentially throughout the u.
Sure. Thanks <unk>. Good good question. So the first of all the fundamental difference the panel off the air Mortgaging panel, whether for isolates or you're on per Se is the same the same SH now looking at bacterial isolates, which would be the first Clarence <unk>.
Mostly in let's call it.
Outbreak monitoring and and epidemiologists settings.
The substantially bigger market opportunity is the urine Pal.
Because there's a well over a million cases of severe critical a urinary tract infections in the United States.
Although I'd say the bacterial isolates of course has the advantage of working from isolates, whether they come from from your N. or other specimens. So it's also very broadly applicable.
In my view I would say <unk> is a great proof of proof of B.S.C.. It's the proof that we can get a F.D.A. Clarence on the platform, it's going to validate the platform.
Running on the thermal Fisher Quantstudio five.
And it'll allow us to basically start building the building the commercial infrastructure get the installed base out sign up customer sides. While we continue with the urine trial and then and then launch the year now how we think about that commercially.
We have already fully integrated the greatest USA sales and marketing team into option. So it's effectively being operating for this past month as a single <unk> one team with the greatest an option folks jelled into one team under the leadership of Chris Emery, Our Chief commercial officer for the America.
As as well and it's <unk> It was our chief marketing and scientific Affairs Officer.
We're looking at the exact same customer accounts for both the Univ arrow lower respiratory tract as well as the Acuitas <unk> and in the future Acuitas you're in panels. So there's real synergy here, we're going to the same hospitals same labore trees same called points and you know it's fair to say that we've.
At least start at the the market education and preparation, it's really a cross selling approach putting together both companies current sites current research. He was only users for the Acuitas funnel opportunities and then figuring out whether an account a is ready for for you know.
Univ Arrow account, adding the Acuitas am our panel or vice versa.
You know, we thinking about the the New York State.
You're of course, right, you know who knows how long to cope with 19 crisis with us although I think the acute phase at least in the in the coming months should hopefully subside now the second wave is always a possibility, but we would certainly envisage once the marching panel is available that all the preparation that's being put in there.
We'll be marketed and sold through the combined commercial team. So channel wise. It. We're we're not looking at having to build a new commercial team that team is now in place, it's fully operational and they're really excited and waiting for the F.D.A. took it was a green light that launched this product in the U.S. market here in the coming coming weeks and months.
Okay. Thanks second question, you mentioned that so.
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Europe's <unk> March is that number.
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Well, it's it's fair to say that certainly in the in the early days in March supply was extremely extremely hard to come by.
Supply has substantially improved in in you know over the month of April into me. So.
Certainly a what we're seeing in in Q2, so far is a significantly.
Increased number compared to March.
And you know again, it's it's sort of addressing a certain segment of the market. This is a a test that runs on the A.B.I. 7500 platform, which is another thermal Fisher instrument system.
It also potentially runs on other similar P.C.R. systems <unk> and you know we're working through our distribution network. These things also have their own rhythm you see a lot of purchasing.
Being handled through for example, the World Health organization regional offices and various European markets. So you know I think there's definitely a potential for growth here.
One thing to remember, though is we we as we mentioned on this call were also working on our own Corona virus test kit, which we believe will have certain distinct advantages of both for me turn around standpoint from a cost a good standpoint.
We have developed a unique and truly differentiated proprietary.
Buffer.
That allows going straight from the swab specimen into the P.C.R. completely eliminating the need for are in a preparation.
Now that not only takes out about 30 minutes of time. It also takes out a significant.
You know it's call it four to $5 cost per test on the on a prep.
A lot of these kids work with you know with for example, Cajun ornate prep kits, which are which are great, but they're short in supply. It's wants to keep bottlenecks. In this situation right now is ornate <unk> not the actual P.C.R.S. nice. So we're really excited about that and again, we're looking at having a product that's a complete solution from those swap.
All the way through to the P.C.R. result at economically much more attractive terms to the to the distributors and customers, but also quite frankly to us with significantly higher margins on our own product compared to anything that we basically by and trade from from a Chinese partner.
Could you, let us know the price.
And also when do you expect to complete clinical.
Oh, sorry.
Yep.
Well, so the clinical validation of our own tests, let's take that one first it's <unk> you know the question of weeks not months. So we're working on it hearing cute too certainly expect us to get that get that done rather soon.
Freshly the the key thing there is how quickly you get access to to a sufficient number of of specimen force with a lot of.
Focus on these political validation studies, but we're working with a number of local large labs and hospitals in Europe. So.
That should should be very doable here in terms of price we've not commented on the specifics of either hour.
Transfer price from B.G.I., nor our transfer is now.
This is standard distribution business typically what you see and diagnostic test kit distribution, you've typically look at distributor margins in the let's call. It 20 to 40 per cent range.
A few backtrack from the publically available information most of these PCR kits in Europe get reimbursed in the various national health care systems somewhere in the 30 to 50 Euro range.
So if that's what the lab charges, you know kind of Ah backtrack, and and then kind of approximate something that that.
Our distributor might be selling to the lab, we're selling to them everybody needs to make a margin so.
Hopefully <unk>.
It gives you a sense of of the the range that you have to be looking at.
Quick follow up for it yeah.
So.
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Market that Oh.
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Have you ever considered a survivor based.
[laughter] [laughter] the letter is a good one.
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Saliva per se, it's probably not an optimal specimen for a simple reason, it's a pretty heterogeneous.
Type of sample now taken a effectively that's what we're currently working with and we've been running our own essay for you know the last couple of months.
Couple of times, a week testing our staff anybody who wants to get tested any day of the week and it's basically you know buckled swap. So it's not one of these super high and as a friend jail swaps that you've got to.
<unk> Forever <unk> initially got to be an independent PCR test kit, because it's going to be running on existing installed base off a regular P.C.R. machines.
Again, whether you look at things like an A.B.I. 7500, a roach light cyclic 480, I you know thermal Fisher quantstudio et cetera. So that's the type of platforms.
Is there the notion of potentially integrating corolla virus test as an essay into some of our cartridge based solutions.
That's a possibility that's part of the you know more more medium term portfolio review and out the for that too you know once we've been able to complete whether or not that product. You know has as enough differentiation. It actually makes sense because again P.C.R. testing for covert itself is is probably no longer the the true bottleneck.
Right now.
And then are we looking at a Europe and the U.S. well.
Given the regulatory pathway I think it's fair to assume that it's going to be that you marked first but are we also looking at the emergency use authorization pathway absolutely.
Also with a a strategic partner that we have in Europe wouldn't matter <unk>, we're working with us and 11 countries.
There was always you know opportunities to think creatively about how we bring additional products to market through existing distribution partnerships in channels. So.
Yeah. Thank you.
Okay.
Okay.
Mhm.
Mm.
So there's no further questions.
<unk>.
I'd certainly like to think everybody for joining us today.
And we look forward to updating you as we continue to progress the business for more information. Please visit with the Investor section of our website, where R.S.C.C. falling and feel free to give Tim more myself recall really appreciate your attendance and thank you very much.
Yeah.
Oh.
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Mhm.
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