Q4 2020 Guardant Health Inc Earnings Call
LNG for earlier stage patients through the launch of Gardner via last week.
This launch marks our formal commercial entry into the estimated $15 billion opportunity of residual disease detection and recurrence monitoring.
We believe we will only grow as clinical and pharma applications of this technology increasingly become a new standard of care.
In screening, we expect to complete enrollment of our eclipse colorectal cancer screening trial and expand into other cancer types addressing an estimated 50 billion screening opportunity.
We also significantly strengthened our balance sheet with two capital raises during the year ending 2020 with $2 billion on cash.
With this capital we are well positioned to aggressively invest in 2021 on beyond which will more firmly secure and open up.
Massive opportunity to transform cancer care for millions of patients.
With that I will now turn the call over to Amir Ali for more detail on our Biopharma business and our pipeline activities.
Thanks, Tony.
Starting with our Biopharma business.
Sample volume in the fourth quarter of 2020 wells flow.
800 on for you on cash.
23% below the prior year per year.
Oliver volume.
We're up 58% from the third quarter on <unk>, reflecting Pasha recovery from Covid.
So a year end rush for sample analysis.
Envelope of services on the other revenue grew 100 on 48% true Gary Kain $6 million.
<unk>, Inc. Our growing pipeline of Cvs partnerships and <unk>.
Prospective studies.
We are pleased with our progress in the pharma testing volumes and growing Cvs partnerships.
However, in the first half of the year.
The impact of Covid to continue to be felt with slower trialing neural net delaying sample volumes as well as Cvs development services.
We are seeing significant interest in our companion diagnostic business. Following FDA approval off guard entry 60, as a companion diagnostic for OS in America.
We are pleased to announce that we have submitted supplemental PMA.
Our collaboration with Janssen.
Amazon Tenet and with Amgen for <unk>.
The selection of Olive Garden entry 60, CTX on the front.
On slide liquid biopsy device of choice in these two programs demonstrates the growing confidence from Biopharma in our IBD offering.
FDA granted priority review or breakthrough therapy designation for these therapies and we expect accelerated review by the agency.
We believe liquid biopsy tests can add additional clinical benefit from cancer patients beyond just the treatment selection.
We had over 40 publications, but non straight out of spec Chem liquid biopsy test a few weeks after treatment initiation camp sedimentary responders versus non responders across multiple camera cash on multiple classes of therapies.
He's very exciting based on liquid biopsy, it's clear that as more of these tools become part of clinical practice, such usage will usher and even more applications. Many that we can't even imagine today.
Now turning to our lunar program.
We mentioned last week, we were excited to announce the launch of garden to reveal the first love only liquid biopsy test for the detection of residual and recurrent disease.
With a simple blood draw this testing from the management of early stage colorectal cancer patients by detecting Cte DNA and love after surgery to identify patients with residual disease.
<unk> knows from adjuvant therapy, and by detecting recurrence Mongst earlier.
Brian entry wheel is net class on its own with industry, leading sensitivity specificity on average turnaround time of only seven days.
Compared to other tests that require tissue biopsy and also have turnaround times of four to eight weeks.
EBITDA, which is the current standard of care, how the sensitivity of 69% with 64% specificity and a survey lifestyle day.
91% sensitivity with Hanmi percentage specificity for garden to reveal.
This level of performance, we can achieve true analysis of over 400, K b of genome spanning across thousands of region that may contain somatic mutation or methylation signals from CRC.
It is vital that oncologists have better tools to quickly identify those high risk patients who may benefit from escalation.
The escalation of treatment.
That platform technology, we use for our MRI day test is based on the integrated analysis of somatic genomic methylation changes, which have potential for detecting tumor types with high level of somatic mutations.
<unk> reached the French share maturation patterns.
Besides CRC GAAP exciting.
Exciting visibility day day in other cancer types, like lung and bladder, which gives us confidence that our blood.
Tests will continue to have market, leading performance as we expand garden entry view from multi cancer types in the near future.
Turning to eclipse, we continue to see robust patient enrolment throughout the fourth quarter free.
We have now over 150 sites actively enrolling patients.
Overall, we are pleased with our progress on are on track to complete enrollment in 2021.
If successful.
<unk> will play a pivotal role in regulatory approval and reimbursement of our liquid biopsy screening tests.
We are starting to plan, our next screening clinical trial and other cancer types.
To share more updates about this in the latter part of 'twenty and 'twenty one.
With that I will turn the call over to Mike for more detail on our financials Mike.
On the Raleigh.
Total revenue for the fourth quarter of 2020 with $78 3 million up 25% from $62 9 million in the prior year quarter.
This growth was driven by year over year increase from both precision oncology testing revenue.
On development services and other revenue.
Total precision oncology testing, maybe reported fourth quarter was $64 7 million.
Both were 13% compared to 67 4 million from the prior year quarter.
Precision oncology revenue from clinical tests of the fourth quarter was $45 9 million from before.
47% from FERC on 43 million per the prior year quarter.
Fourth quarter clinical test volume was 72 parents on crude into the <unk> 53 per protein to form from the prior year quarter.
The clinical transplant with selling price was 2642 from the fourth quarter points to improve.
Up from two positive quoting on the prior year period.
Which also 9% increasing the clinical test ASP over the prior year quarter was principally due to expanded them up to corporate average of non lung cancer tests, which commenced in March 2020 on our success in gaining private payer coverage.
Our low clinical test volume increased sequentially by 2% in the fourth quarter compared to the first quarter liquids directed.
Clinical test revenue of $45 9 million decreased by $2 4 million compared to $48 3 million in the third quarter of 2020.
This was primarily due to quarter over quarter fluctuations and the revenue recognized from cash collected per test performed in prior periods, which in the fourth quarter of 2020 was $3 million lower than in the third quarter of 2020.
Precision oncology revenue from Biopharma testing in the fourth quarter totaled 18 content moving.
Foreign currency, 8% from currency on 2 million for the prior year quarter gross.
Sequentially up 57% from $12 million from the first quarter of constant currency.
Fourth quarter Biopharma costs totaled 4841 down 22% from the prior year quarter. However, sequential test volume was up 58% from the third quarter of 2020 due to a partial recovery from the Covid unusual year end seasonality.
Biopharma test ASP was 3892 down slightly from 4100 and substitute in the prior year period.
Changes in the mix of tests performed.
Development services and other revenue in the fourth quarter two.
With $13 6 million.
148% from the prior year quarter.
Gross profit for the fourth quarter of 2020 was $49 9 million compared to a gross profit of $41 1 million from the same period of the prior year.
Gross margin in the fourth quarter was 64% from.
It's a 65% during the fourth quarter of 2000 ounces.
We expect from our gross margins to continue to be in the mid sixties range for the foreseeable future as we launched new products, such as gone revealed which will take time to gain reimbursement coverage from Medicare.
Gross.
Total operating expenses for the fourth quarter of 2020 per 141 per $1 million or 110% increase from $6 seven per zero million from the fourth quarter of 2019.
This change was driven by an increase of $51 3 million stock based compensation expense primarily related to market based restricted stock units relative to the company's founders in May 2020.
As well as our continued investments in developing and commercializing new products and services and in scaling our operations.
In 2021.
Stock based compensation expenses to be between 107 to 118 million per per year.
In addition, we expect operating expenses to accelerate in 2021 as we continue to invest on our lunar program eclipsed another development on services as well as launch new products on it from a commercial organization from both the U S and internationally.
Net loss attributable to guardant health common.
From the stockholders was non acute point $7 million.
<unk> 19 cents per share per the fourth quarter of 2020 compared to $25 2 million on 2007 cents per share in the fourth quarter of 2019.
Adjusted EBITDA from the loss of <unk> 9 million in the fourth quarter of 2020.
On page $17 1 million loss in the fourth quarter printed on team.
As a reminder, we define adjusted EBITDA as net loss attributable to guardant health adjusted.
Based on associated interest income tax depreciation amortization other income or net expense noncontrolling interest contingent consideration acquisition related expenses.
Turning now to our full year 2020.
Total revenue was 200 net six 7 million.
34% increase from $214 4 million in 2019.
Precision oncology revenue increased 31%.
$236 $3 million from its comprised of clinical testing revenues of $178 million, which grew 70% year over year on Biopharma testing revenue of $64 5 million, which declined 19% year over year.
Despite the adverse impacts of Covid.
Per principal use per the year grew to 62264 of 27% year over year from.
<unk> 9000 in 2006 gross.
The average revenue recognized per clinical test in 2020 gross debt to focus on from the prior year, primarily as a result of the expanded Medicare coverage of non lung cancer test, which commenced in March 2020, and on success in gaining private pay coverage of our tests.
Clinical revenue per year at least December 31, 2020 also included $11 9 million revenue per payments from Medicare from peers percentage closer to prior years compared.
Compared to $6 8 million revenue in 2019.
The company does not expect to continue to receive payments our reported revenue for the specific appeals in 2021.
Biopharma testing volume was also impacted by Covid in 2020.
And despite a partial recovery in the fourth quarter to.
<unk> declined 23% year over year to 15983 times.
Development services and other revenue grew 49% to $54 million from 2020.
From a growing pipeline of CTX partnerships and prospective studies.
Net loss attributable to guardant health common stockholders was $252 8 million compared to $75 7 million to 19.
Net loss per share was $2 6 billion in 2020 as compared to 80% from 2019.
Adjusted EBITDA was a loss of $8 2 million in 2020 compared to a loss of $53 3 million from 2019.
We ended 2020 with $2 billion in cash cash equivalents on marketable securities.
Now turning to our revenue outlook for the full year 2021. Despite the fact that we are still in the midst of a global Covid pandemic, who do the fundamental drivers of our business to be very strong.
Such Expo 2020, low revenue to be between 360 from $370 million.
Representing growth of approximately 27% over 2020 on the mid project the range there.
We expect clinical sample volume for terms towards you up to the growth from our 90000 tests, which represents growth of at least 43% over 2020.
And that we've been on outlook RPT assumptions around reimbursement.
Firstly, we anticipate by the upcoming billing code changed to government 360 <unk> in April.
To enable LTE PLO growth.
Short term impact on private payer reimbursement, which could offset any positive impact we see from an increased ADL TV investment late from EBITDA.
Secondly, although we are excited about the launch of new tests, such as gone it will be it will take time to receive medical coverage and subsequent private pay coverage and also we do not expect until 2021 revenue it's been material for these new tests.
Hello, Amit.
Really both function, we are still experiencing COVID-19 related impacts across our clinical and biopharma businesses and we anticipate that these impacts will continue on the first half of the year.
Specifically from the first quarter of 2021, we expect to see a reduction in biopharma volume compared to the seasonally high fourth quarter of 2020.
Furthermore, as I mentioned earlier, we do not expect to record revenue in 2021 from Medicare Appeals for samples processed from prior years, which in the fourth quarter of 2020, such as $4 6 million.
As a result of these factors we expect revenue in the first quarter of 2021 with sequentially lower than in the fourth quarter of 2020.
However, as we meet the on some of the Covid headwinds and coding transitions in the first half of 2021 day.
Net revenue growth accelerated pocketbooks, 30% by the end of Q on.
At this point I would like to turn the call back to hub for closing comments.
Thanks, Mike before closing I wanted to again, thank our team on garden for the dedication and effort. They have shown particularly over the past few quarters I believe that 2021 will be an unprecedented year for Gardner as we are bringing to fruition division. We had when we founded the company of significantly improving outcomes across.
The entire continuum of cancer care.
Indeed, this will be a pivotal year in terms of the number of product launches and the planned breath of our product portfolio.
I am confident that these product launches will serve as drivers for strong growth in 2022 and beyond.
New products also mark an important inflection point as we begin to transform garden from the leading liquid biopsy company could a leading cancer testing company.
With that we'll now open it up for questions.
As a reminder, if you wanted to ask a question you on its press star one on your telephone.
Star one on your telephone if you wish to ask a question.
Your first question comes from the line on Brian Weinstein with William Blair.
Hey, guys. Thanks for taking the questions.
On lots you mark to get into here, but we've heard a lot of companies. This earnings season talked about significant investments.
Going into 2021, given all the new products that are out there.
I'm curious if you can talk about the specific investments that you were making I heard in the prepared comments, Mike had made some comments about opex going up but more specifically can you talk about where those investments are are going you can give us some idea around specifically around things like preparing for CRC.
Launch, which.
It's still a little bit of ways, but something that you have to start to be thinking about or commercial efforts for <unk> assay.
As you think about scaling that up or anywhere else. So I'm, just curious where where do you think the key areas are poor investment this year.
Hey, Brian.
Okay then.
Yes, we're making investments across the organization I'll start and then Mike.
Mike.
But certainly an appropriate from a price on that.
On a day from December.
Sure thing.
Certainly on new products and the entire order.
Yes.
From.
RMB per occurred.
On the programs we are.
Certainly scaling up on the commercial.
Either low or amortization of as it is.
But aside from the billings growth rate spending into other parts of oncology.
And starting to think about.
We raised on the finish line on the curve.
Really the commercial planning stages for that.
On program.
Yes, maybe just to add.
Brian.
Part of it.
Particularly on the investment as you mentioned.
And when we looked at the operating expense that we think thats going to.
To round, because we as we make these investments.
Like an increase of $150 million to $290 million.
Increase over the year on compared to 2020, so yes, that's what we're that's what we're looking at the shape Inc.
Got it thank you and then.
As it relates to reveal can you talk more about kind of the basis of competition here, how it may be different than other products.
In oncology based diagnostics and if you think that having to increase if we are already in the market clinically. It's something that provides you already kind of kind of clinical advantage when talking to clinicians.
Maybe on an early on.
Okay.
Yes sure. So once they are actually are just a couple of rate sensitive commercial activity care on garnet and Hugo boss, So Brian <unk>.
Very good very excited on the answer is yes.
Clearly many of our.
Kols on technology.
Kind of early adopters that we are targeting to have these days are overlapping with the type of people range track that cologuard entries.
And on particularly with respect or on the quality of the product and services that they've got from garden's health throughout the years.
EMEA.
Very happy with the fact that we are.
All of these cash that does not depend on having.
Access to check average issue on that also.
Good day market, leading performance, while logistics is much better turnaround on responding better it doesn't come on site.
The size of the cleaning process and specific to further create.
Really the way they are.
CA either.
I'm curious about Commerce day shutdown for your high bandwidth of doctors at this time on the delta between reveal.
CA is very obvious on the health on a sub 64 69 versus 91 Andre.
As I said very big Delta that generates a lot of excitement.
Your next question comes from the line of Tycho Peterson from J P. Morgan.
Hey, thanks so.
A similar line of questioning on the tissue launch just curious.
And what do you think the market was running machine between foundation care some of the others. If you could.
Confirm specific launch timelines and how youre thinking about share capture and then also on the FDA approval pathway.
Yes.
Thanks.
It sounds like.
The thought about for some time.
It was really a matter of when.
Non.
Let me look sufficient space.
Includes bill quite surprised at how much of a challenge ordering new patient growth.
<unk> continues to be if you think about it.
Anytime from a positioning point of view.
Three to four weeks.
Yes.
Hey, there.
The growth in days, but in terms of the tissue acquisition actually in the result.
It takes three to four weeks, which is a non starter in terms of the.
Time to treatment decision.
I apologize.
The frontline setting.
So we realize that the range of our on hand.
And really capitalizing on the market.
Net.
So those are on patient growth.
Is it really integrated with our current offerings.
Variety of users.
Customer experience that is completely differentiated in terms of getting more markers faster and quicker and more from gateway.
Yes.
<unk>.
We expect to be able to provide the division. So the way we think about it.
We'll be able to capitalize that.
Paradigm in the market.
And I think it's a low base, we will set on being able to take.
Considerable share from.
Some of the existing players, but some of the challenges that exist.
There is still a large percentage of the basin.
The presentation deck.
Volume genotype comprehensively and even more of an orange.
On buying setting.
The treasury.
Treatment and as such on the list.
I mean, we think moving squarely address whether this tissue offerings.
We haven't really had a timeline on it.
In terms of the.
For the others, but based on.
Okay. That's helpful and then on <unk> hundred 60, just curious how we should think about the mix.
<unk> hundred 60, and then the LDP.
Yes, I think you can imagine that in on both 360, <unk> and a half day or on lifecycle management Cba's amongst relative guidance on faded as the IBD great device.
Three months EBITDA guidance <unk>.
Yeah, Brian device.
I think now.
Sure.
Portfolio would really enable us to be nimble and add.
Nearly all coming Biomarkers.
On the clinical practice or on the pharma trial practice tactically as their entire offerings.
And Cvs would be flow through the revisions weighted.
Florida three months as I mentioned that both of them on triangle operated and reported a foreseeable future.
Okay last one just curious.
As we think about the eclipse study kind of getting wrapped up later this year and any comments you guys can make on on follow on studies for lung breast from some other indications.
Yes sure.
Really excited about the stock based ads b.
Sure.
I think on oil pipeline.
Starting two years ago, when he talked about our ambitions around the early cancers screening.
Before that we talked about force answering price at the time of aircraft, Spain, CIC was one up on <unk>, almost lung cancer breast cancer and ovarian cancer.
Sure. Thanks on pilot data, our stomach cancer types earlier and remains on progress first office asset types. So.
We believe they have a platform technology that we have that integrates genomic biomarkers epigenomics and on the epigenome.
Genomic side.
Installation on plus of this strike Charles changes as a result of fragmentation on pattern changes.
So very powerful refined cash servicing various stages of disease.
<unk> as a result of available data that we've seen Inc.
Neither Castro died.
And created a primetime that out there, we really get at cliffs.
The last innings of it.
Our tire Kingdom doing some clinical trials around other cancer types.
Charlie on that program would be a multi fasteners and profile.
<unk> cash will be our lead indication despite the price.
Okay. That's helpful. Thank you.
Your next question comes from them on I'm, Doug Schenkel from Cowen.
Hey, good afternoon, guys. Thank you for taking my questions I want to start with a high level question and then I want to come back and talk about something specifically on guard on reveal.
So first the high level question.
I think it's fair to say that you guys have established yourself as.
Early on one of the adults in the room when it comes to developing liquid biopsy tests in a responsible way.
You quickly got a seat at the table early with the FDA and CMS and groups like ACR.
This put you on a position to not just launched <unk> hundred 60, but to do it successfully with clinical and regulatory rigor that resembles what those of US who grew up in biopharma saw there, but didn't see often in the early days of diagnostics.
That said.
The market is getting more crowded as menus from competitors seem to be evolving in a way where.
It looks like Theres going to be 4% to five companies down the line that look quite similar in terms of what they offer what their menu looks like and I think that's going to happen in the next four to five years, if not sooner.
That's long been our view, but I think the pace of moving towards that is accelerating I mean, even you guys have come up a couple of times on this call launch the tissue products.
On the <unk> product is coming to market a lot more quickly than we anticipated. So my question is.
How should we expect guardant to differentiate over the long term when you in four or five other companies have IH menu that goes from multi cancer in a single cancer screening for therapy selection and blood and tissue to monitoring whats going to differentiate garden from others in the long term.
That's a great question.
From a time on thinking as a company.
It's not just fundamentally on the differentiation even on therapy from them.
<unk> loans.
Yes.
From a couple of dozen company and in the local growth.
And on the surface.
Theres always on competition, there's always in a crowded field.
But in reality, it's early the quality.
Level of performance of these products the level of clinical evidence.
Early the customer service channel on the White Glove service that we provide billing and reimbursement.
Will it take.
On dimension.
Early in the changes in cash.
Area change clinical practice health care.
As you all know.
And we believe that we are second to none in each one of those as I mentioned just from therapy selection, but really taking that same approach to these new products that we're launching on low end so yes.
We're actually I think.
Pleasantly surprised by how much differentiation still continues and this growth 316 vs.
That has been launched.
There is no different with the reveal on this growth.
And there is abundant.
Good day.
Right.
But we'll reveal now is really the only one.
We believe true liquid biopsy and the market share.
On the ended.
Really the advantage of the Brexit without any disadvantages in terms of performance.
Service and customer experience.
If you think about the other.
The one company that really does.
Okay.
On the channel and oncology market.
<unk> 9000 in Poland This quarter.
Further on.
Earlier broad reimbursement for <unk>.
So that's quite a burden.
Okay.
I am very pleased with relative markets.
First thing I would say the competition is important.
Because of declining market is bringing awareness of new products.
I think it is.
Really allowed.
<unk> standard and.
And claims from customers understand really the.
Used cases.
What good looks low.
Alright.
Really not a differentiation in terms of the performance of our products from the performance of our services without a backdrop.
Thanks for all that that's helpful and interesting and now for the reveal specific question.
In your recent.
Presentations on our press release I think you indicated that reveal has a sensitivity of 91% you talked about that on your prepared remarks today as well.
I believe this improvement is at least in part attributable to the fact that on top of methylation markers and you've now added genomic alteration assessment to the assay.
I may be oversimplifying, or maybe misstating, this but assuming on going down the right path.
Im just wondering if.
The addition of these additional markers, which seems to be important to import the improving performance.
Led to any other compromises as part of the assay, specifically I'd love to just hear if you think you need to.
Basically you require a larger sample size too.
Accommodate the additional markers on this asset and then simple.
Probably a more simple question and I know it's early.
But I believe that most would would assert that there is an inherent advantage to using a non bespoke cash versus a tumor informed cash if there are not other compromises required.
I know that's your belief.
Are you hearing anything in terms of early market reaction or market research that is consistent with that view. Thank you.
Regarding the <unk>.
Our platform technology for <unk>.
Gil maybe starting with that 91%.
Yes.
Script actually Thats defensive at this survey LMS and on one here on trying to maintain that R&D relapse.
The balance rates have actually the operating teams Trc Stephanie.
Now.
This is the exact same assay that we're using in our clinical trials for Brian spend up to contract value.
<unk> stopped processing prove that happened or.
Together.
This device.
On a potential.
On our K Cup this device in the years to come.
The process on operational infrastructure as Inc.
Our device, but.
I would say on in fact, the curve progresses very very similar to what we are doing our comparative and shelf space for breast cancer and others.
Studies.
But yes. The core platform is based on combining an invigorated Inc. Multimodal information from the same cell free DNA pipeline.
Which in this case, we are combining somatic and based on excavations.
For MRI.
Mark <unk> setting.
Reaction the kols on target.
<unk> growth that we add chillers.
As I mentioned during the second week of those covenant shall launch, but all the conversations so far has been very very.
Positive.
<unk>.
This is really resonating with customers that we're talking to so far.
All of the assay.
<unk> really health care practice tremendous SP on an end of Datacom per products with other blood on the standard of care as day by FCA and there is saying that the performance on the promise there is a big Delta in terms of performance on promise and that generates a lot of Op Inc.
Sites on having.
Having said that.
It's got it takes outside prided ourselves on this debt multiple conversations.
In order for this thing to get on that.
At the outset, but there are still appropriate.
<unk> on the market, what we put out there.
Thank you for that and just one thing I may have missed on that answer in terms of the sample size requirement nothing nothing different with the current version recognizing that it's pretty consistent with what you're doing as part of that other study.
Yes.
From a number of larger with Ya man in terms of sample types. It's the same number of blood chipset, Inc.
For our clinical trials is exactly that Sam its mark.
We made it our scalable on top of the infrastructure on the operational aspects of it.
The devices the SME loans.
Because on average and on the.
But the genomic panel.
Yes.
Brian.
Okay, Alright, thank you very much.
Your next question comes from the line.
<unk> powder from SVP Leerink.
Alright, great.
Thanks, Tony.
Merrily.
First question I have is on guidance you're projecting 90000.
In terms of test volumes here, which feels pretty robust.
But the revenue growth.
For the full year, it's coming in slightly lower than what we had anticipated.
And so I just wanted to hear.
Youre pointing out Biopharma volume production in the first quarter on Medicare Appeals also not being included so low.
I completely hear you on that but.
Just wondering maybe could you give us a view of where you stand in terms of.
The demand that's coming through Biopharma for Biopharma services on the.
<unk> hundred 60, currently and what is the demand outlook from Biopharma, Inc.
Throughout the year, because as I view, it not only youll see a demand from those products, but you also see demand from.
The recurrence monitoring product.
And potentially some other products that you could potentially launch so just wanted to get a sense on how.
Should we view the biopharma growth.
Mike.
Yes, yes.
I think when we look at the Biopharma growth I mean, we think thats going to be strong we think it will be.
Low double digit growth so coming on line.
Robust performance I think you mentioned that.
The difference even though we took on strong critical volume may be a bit of a difference from the numbers you on.
And I think the main driver.
On the clinical ISP.
We saw the ISP being around.
2006 hundred in the fourth quarter, and that's probably likely to be the ISP income.
2021 are laid out some assumptions on reimbursement is around new products.
And not expecting reimbursements for those on.
On material revenue for those on.
So potentially the issues with private payers as we switch to <unk>.
<unk> two <unk> code. So I think really the discrepancy is not coming from Biopharma volume, which again, we think is strong this more on the ASB assumptions.
Okay, that's very helpful.
And then on the Eclipse study.
It appears that enrollment is progressing well I'm wondering if we should expect anything any other data sets that were smaller cohorts and whatnot.
Maybe ACR you have DW are coming up as well and as <unk>.
Could you maybe just elaborate.
Potential for any data sets smaller dataset, there and again if you could just maybe clarify on the timing of the readout care for a close because I think that's highly anticipated.
Hung investors.
On the Maryland.
Sure so in terms of the upcoming data.
I would like to make major Congress and we are back on now.
<unk> net.
Our collaborators are better.
Contributors of data every day has started device through a bunch of.
Elaborate as to assess the performance of our spanning assay in Yukon cohorts, having said that.
All of those cohorts is kind of in a biobank setting.
And there are similarities to expand that type of data, we showed before ratios, but it's going to get free asset.
I think so far on all the data are positive that mark.
Aside from Congress as buying traveled on the data set similar to what you expect from a platelet switches from.
<unk> got 10 outlet.
Yes.
Yes.
Such day that there will be really get it from a cliffs range.
Seems to be still patient on for that study percentage.
Okay, and then last one.
And then yes go ahead.
The second part of your less loans.
Yes.
Just in terms of in terms of the.
Timeline for eclipse.
And given the growth.
The robust enrollment that youre seeing there.
Yes, so so far actually we are expecting that.
Steady.
By the timeline that we already mentioned, so true quota that ebb and flow up and balance, but overall I think we are on track to finish on.
On the timelines that we always mentioned on.
So far so we'll see how it is bouncing on steering that remain there of that next few months.
Okay, Great and last one if I could squeeze in on.
R&D and recurrence monitoring obviously.
You have had data here in CRC, but when we look at another competitor on space.
There is slightly.
So it'd be more publications more datasets that have come out obviously gardened is focused on building a strong clinical evidence for its products and as usually the first one to do so so maybe just if you.
Good.
Elaborate for US the efforts that you are doing on on recurrence monitoring CRC and maybe indications beyond that in IR longer breast that could potentially yield.
Further datasets on clinical evidence that helps position.
Look at the assay more closely.
Thank you absolutely.
It's actually our finished several other loans which are ongoing.
On my script.
On the data that we are talking about in terms of performance of our reveal is coming from our collaborator standard.
Our.
A major part as measured Castro.
Space, So the manuscript under review, but hopefully.
That will get published.
And your next question comes from the line of Tejas Savant from Morgan Stanley.
Hey, guys.
Good evening, thanks for the time here.
Help me and him early on.
On the tissue biopsy launch.
How many you've spoken a couple of times about sort of the importance of reducing the turnaround time there.
The entrenched sort of tissue biopsy competitors.
How much shorter do you think that turnaround time can be particularly given the fact that a lot of time since the pathologist to take some time to GAAP.
Drew on the sample and send it off to the lab.
How exactly do you plan to sort of.
On a compressed that timeline relative to some of the other competition out there.
That's a great question.
Or liquid Budd.
Everything about it.
Good day.
From the turnaround time, and we look at a low to other lipid Budd is out there.
An important index amended.
On Monday and longer.
And that's not even day bandwidth on consolidated time on getting tissue.
Certainly I.
I think.
The level of automation and operational excellence that we have in our organization.
It doesn't seem to be asked for other products that are out there and so clearly there is a lot of unknowns.
Confer and apply to that issue.
So I'm very confident about it.
It's not just about the tissue product on its own.
It's also about how these products work together.
Liberated from the tissue product.
And I think having that sort of integrated offering.
Customer experience, which is.
More aligned with.
And quoted on this team which is made.
Making sure they get relative terms.
On the Biomarkers and their patients as quickly as possible and not missing anything and we think we'll be able to provide.
And that is at a level that really hasn't been seen.
Good day.
Got it that's helpful and one quick follow up for Mike.
Just in terms of the guide here.
What are you sort of intuitive.
Including four O U S expansion I mean, obviously, you've got the allowed to Brian Brian.
From ship you announce.
On the Japan expansion as well so all U S. And then on the development services front I mean, obviously.
Sort of an uptick in 2020 there.
Much of a normalization should we expect on that line item in 2021.
Well on the on the O U S book.
We're not breaking out those numbers.
But we think that.
It's a great opportunity for us and probably an opportunity for <unk>.
Our upside throughout the year.
Us too.
How that goes in both Europe and in Asia on the.
The development services side.
Yes, I mean, we've been this strong.
Stronger over the last three quarters actually on so I think that that will continue through the year.
Good bullish about.
On the development services revenue.
2021.
Alright, thanks, so much guys.
Yeah.
Your next question comes from the line of Derik de Bruin from Bank of America.
Hey, Thanks for squeezing me in just a follow up on Eclipse could you just sort of like outline a little bit more.
Once you get the readout the potential for commercialization.
Your general thoughts on LDP vs inclusion in guidelines.
We think this is an area we skipping a lot of input from investors just basically wanting to understand what's your approaches and do you need to go out and build a sales force and is that driven built into your plan just a little bit more on your on your on your commercialization efforts on on Eclipse would be really helpful and that's my only question. Thanks.
Further and further.
I think we started it in November of 2019.
But on a per months.
And Thats whats the timeline for enrollment will be opaque.
On another little bit of volume too.
Simple.
It correlated.
Good.
In the meantime, clearly we're very optimistic.
The performance, we released data.
On the data already in other cohorts.
Where we are and what we believe is performance.
We'll meet the standard.
Principal.
That's been.
Outlined on the NPV per Medicare coverage.
I think we're cautiously optimistic.
But still be able to read out.
Well above those.
And so in the meantime, we are laying on the.
Foundations for commercial.
And the primary care space.
Clearly very large segment.
And our numbers a couple of hundred.
Rather than primary care physician.
So that does take considerable investment.
They are.
In the early stages of building out the team.
Yes.
The data readout or ready to go.
Your next question comes from the line of Patrick Donnelly with Citi.
Great. Thanks, guys help me maybe.
Maybe one for you just on the guidance certainly appreciate that you guys volumes were pressured nearly as much as other diagnostic tests during COVID-19. The recovery, we're not going to be quite a sharp can you just talk through I guess the impact you saw as we went through <unk> and then the level of conservatism.
Baked in here as we think about the trajectory as we go through 'twenty one in terms of patients coming back again, obviously the impact was on quite a significant given your patient set but just curious in terms of how you factor that in.
Volume guidance.
Yes, Sir.
I can touch on.
So, yes Q4 was interesting.
Coming off the heels of our loans from.
Cvs.
And we really saw a nice acceleration in terms of the number of physicians ordering on a.
Volume that we're seeing from business both on the.
So it's very encouraging.
No I think the resurgence.
Okay.
On the greater than most.
Really.
And before that.
I'm really proud of.
Significant.
In terms of office closures I think.
Well below 20% in terms of <unk>.
Person.
This is really similar to the height of the fund them in April and May in terms of access.
And so it's a very challenging environment to be able to so.
There, but I think that despite the inc.
Very nice.
Year over year growth in Q4.
And so I think it's a testament to both the.
Differentiation of the product is low.
Really the resilience of the garden team on board and resilience.
Additional offices.
Two I think deal.
The patient care and low environment.
I think baked into the numbers for 2021.
On a considerable growth there in terms of clinical volume.
90 loans.
Over 20 funding.
So I think we are we are very low.
Bullish in terms of really continued adoption of this COVID-19 thing I think the challenges are.
It's certainly going to continue in the first half of the year.
We expect.
We're seeing Covid is in.
Decline hopefully they continue to do so over the next couple of quarters.
We were able to see.
Further acceleration of growth.
Of the year.
Maybe a range statistics on both.
You said, it all but really baked into our assumptions.
As COVID-19.
Of course that was impacting dependent.
Rollout of birth rate, we built into the numbers for the Covid impact in the fourth and the first half of the year on.
And then making an assumption that in the second health.
So that alleviated so.
So thats, how thats, how were looking at EBITDA and Thats facing two on numbers, but having said that we still think if we achieved 90 passes.
Clinical tests.
Sure that will be a free.
Strong growth.
That's helpful guys I appreciate it.
Your next question comes from the line of Dan Arias from Stifel.
Yeah, Hi, guys. Thanks for getting me in here, maybe just one from me on reveal.
Obviously, you guys are looking to get settled here in colorectal cancer first but just to the point on usage in a broader setting.
I'm just curious where you are in terms of your thinking about.
How quickly clinicians might look to translate confidence in one tumor type to usage and another on other words, if you build on the asthma data and a cobra rebuilt positively to net.
Sort of be the gateway to adoption in other cancers.
Do you think that you kind of have to true things out tumor type by tumor type.
And then most recently borrowed from a revisit of the true.
And so it really.
On a singularly focused on on loans initially.
And what we found was the.
By using a compass that Lisa regimen of non clinical utility.
That really maximizes the positive reaction of the users.
These products.
Find utility.
There's decision making in lung cancer.
Given the many physicians are generally.
On many other cancer types.
On that day.
On the kind of.
Translates into.
Positive.
Assumption.
And Christine clinical utility and other cancer types as low in both.
Yes.
The strong trends from the lung cancer.
<unk> seen growth in other chemicals.
Continuing to track the growth that we've had.
Add in lung that being said as we improve it.
Cases for any utility in other cancers.
Those can be added drivers.
Indications so we can take the.
Basically when we have a drug approvals on breast cancer.
And from.
Based on some on them contain considerable that come from increases in volume.
On the indications and so we.
We believe that it will be no different.
Those products with government.
Okay. Thank you.
Your next question comes from a line of Max Masucci from Canaccord Genuity.
Hey, Thanks for squeezing me in.
The prepared remarks, you spoke about the 65% decline in new diagnoses of cancer in 2020. Unfortunately, some of these patients may never have the chance to receive a garden 360 test, but I'd imagine that for those that do it will be there'll be diagnosed at a later stage. So how are you thinking about this playing out in <unk>.
'twenty, one probably more on the second half and is this something you can act upon proactively and forecast in 2021 or not so much.
<unk>.
Yes.
The growth.
Exactly how much of the backlog is that fair.
That was great given the.
Different timescales on.
In terms of diagnosis.
The disease.
Did these days.
Net.
<unk>.
So many patients still on non Compliances with unit.
I think that though.
A lot of room to grow even outside of that book.
Whether it per se.
Non.
I think they are.
From a book.
Bullish in terms of continued volume increases in terms of the RMC.
As a low incidence of other products on down the line and so we're still very much in the early innings of adoption of these type of income.
Okay.
Great. Thank you.
There are no further questions at this time.
I would like to thank everybody for joining this concludes today's conference call you may now disconnect.
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Yes.
Okay.
Yes.
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