Q3 2021 Guardant Health Inc Earnings Call
Only liquid biopsy test that detects changes in circulating tumor DNA levels to provide an early indication of a patient's response to treatment.
It has confirmed our cell free tumor DNA levels were decreasing meaning she was indeed responding to treatment and their symptoms are likely a side effect from the therapy.
With this her oncologist ebb information he needed to continue treatment through the trial and the patients symptoms have since improved.
This story highlights how garden <unk> system can provide powerful information across multiple stages of cancer care from rather treatment selection with our garden 360, Cvs. So early treatment response monitoring with garden $3 60, a response.
Today, the garden 300 active product portfolio is increasingly providing oncologists with a set of comprehensive tools to unlock the full potential of precision oncology across the continuum of advanced cancer care.
Now turning to our performance, we realized record revenue during the third quarter of approximately $95 million growing 27% year over year.
On our earnings call in early August we share that the resurgence of COVID-19 cases was impacting oncology office visits and sales force access with our end cash international business, particularly impacted.
While the environment Didnt worsen these impacts persisted through August and into September.
Despite these continuing impacts from Covid, our team delivered strong clinical volumes of 22800 success up 9% from the second quarter of this year and 35% compared to the prior year I continue to be proud of how well our commercial team is executing in this environment and achieving healthy volumes and continue.
Growth.
Notably approximately 60% of our volume in the quarter came from the community setting which represents over 10% growth over the previous quarter.
We have also continued our strong cadence of clinical evidence supporting Garden 360 in September we shared new data Islip World Conference in lung cancer. The demonstrated advantages of using the garden 360 liquid biopsy test for clinical decision, making in advanced lung cancer.
Shortly after we showed data at ESMO, highlighting molecular targets of importance treatment resistance patterns and advantages of the gardens <unk> liquid biopsy test to help improve the management of advanced solid cancers. These.
These studies add to the growing evidence demonstrating that garden 360 is an easy and quick way to identify more patients with actionable biomarkers, allowing clinicians to start biomarker informed treatment sooner as compared to tissue biopsy of our comprehensive genomic profiling.
Turning to recurrence monitoring.
We are encouraged by the growing interest and early success of garden reveal and are continuing to invest heavily in the vast opportunity ahead, while leveraging our existing channel with oncologists.
We now have a full commercial channel dedicated to reveal and have added over 50 employees to the team during the third quarter.
Across our oncology portfolio, we have a commercial organization of more than 250 employees across sales marketing and medical affairs.
We are making solid progress towards our multi cancer go with data on colorectal cancer as well as bladder lung and breast indications similar.
Similar to our approach to therapy selection, we are investing in clinical studies across MRV to demonstrate the clinical utility of our test.
To that end NEF tober, we initiated the Oracle study to evaluate the performance of Gardner reveal to predict recurrence across many early stage cancers.
Specifically this is a thousand patient prospective observational multicenter study designed to evaluate the performance of reveal to predict cancer recurrence after curative intent treatment across 11 solid tumor types.
This study in combination with our existing studies would establish clinical evidence for Gardner appeal across nearly 80% of all solid tumor cancers.
The first patient was enrolled in early October.
If successful Oracle will pave the path for reimbursement for Gardner appeal across multiple cancer types definitively.
Establishing the blood only approach for MRV and unlocking the $15 billion total addressable market for MRV across all tumor types.
Moving on to Biopharma, we saw a healthy rebound in our biopharma business with volume of 4000.
839 samples of 32% from the second quarter and up 58% year over year.
We are seeing growing interest with our Biopharma partners are using reveal in the adjuvant setting with non trc indications such as lung bladder and breast our partners are seeing significant benefit with a blood only tissue agnostic approach and we look forward to growing usage of review on the Biopharma setting.
In addition to increasing sample volumes the number of customers. We serve continues to grow we now have more than 90 active biopharma partnerships with a healthy pipeline and we expect to have more than 100 partners by the end of the year.
The breadth of our product offering strong customer service and clinical market leadership makes us an attractive partner.
Outside of the United States, we continue to expand our presence in Europe through established partnerships with the Premier cancer organizations, we have partnered with the Royal Marsden, a leading specialist treatment hospital in London. This is similar to the previously announced <unk> partnership in Spain, which establishes in house liquid biopsy testing.
Services running garden, 360 and sequencing onsite.
This service is expected to become operational in 2022 and will be available for clinical research and clinical care, providing industry, leading next generation sequencing to private and self paying patients with a plan for future expansion for National Health service patients.
In addition, we continue to make important progress with our JV in Asia, the Middle East and Africa, specifically in Japan. We are on track for PMA approval of Garden, 360, and launching our clinical laboratory outside of Tokyo by early next year.
We are also making excellent progress in other countries in the region as well as growing clinical volumes were both biopharma customers and oncology clinics.
Accordingly, we have decided to exercise our call right to purchase the remaining 50% of our joint venture from Softbank.
We are working towards the future, where all patients with cancer around the world have access to the latest innovations to inform treatment decisions and managed care for the best possible outcomes.
This additional partnership in Europe, and a redoubled commitment to our efforts in Asia Africa, and the Middle East are important steps towards realizing that vision.
Finally, before I turn the call over to Amir Ali I wanted to take a moment to welcome Myrtle Potter to our board of directors.
<unk> currently serves as Chief Executive Officer, and Board member of Sumita event Biopharma.
<unk> event Myrtle served as the president of commercial operations at Genentech Merck.
<unk> has previously served on the boards of Amazon.
Scripts Medco health solutions everyday health among others for extensive knowledge and experience, bringing the world class healthcare products to market will be invaluable as we scale our organization.
As garden growth I continue to be amazed by the incredible talent, we are bringing onboard joining our efforts to bring the best products to market as we strive to provide patients across all stages of cancer with access to the latest advancements in precision oncology I will now turn the call over to <unk> to provide an update on screening.
Thanks Tommy.
At the garden and we've always believed that a blood based screening test during wellness checkups as the potential to guard against cancer.
Blood based screening at the same toll reduces the need for patients followed through its much easier to integrate into a health system workflows expand accessibility to underserved communities, our would likely improve the compliance screening tests.
That said the complexities of malignant disease.
The imperfect nature of screening tests and they are more bds associated with follow on diagnostics mean that early detection.
Not in transit equate concert positive net health benefit.
Net health benefit of early detection versus potential harm from unnecessary screaming at Balboa diagnostic procedures varies for different cancer types.
For instance, a large study showed that while it is possible to final ovarian cancer early and long term outcomes. Sadly we're not these transport cancers detected early versus later at least based on the current interventions.
And Sam Hematology malignancies, such as chronic lymphocytic leukemia, Andy chemotherapy confers no survival benefit to patients diagnosed in the early stages and may introduce significant psychological at key events financial distress credit condition, and which now street.
As required.
Some investigators have applied blood based screening events low sensitivity test in a one size fits all approach regardless of cancer type with the presumption that early detection is always positive.
In contrast at Garden Intel our focus is to develop a highly accurate blood test to screen for cancer tax for early detection can offer a clear net population health benefit.
We started our screening program with CRC, whereas the patient compliance rates with screening remained stubbornly at 66% in a disease, where it's screening reduces the risk of death by 62%.
In addition, we believe that David opening a highly sensitive blood tests less visible and the regulatory approval and reimbursement pathways very clear.
We launched eclipse our prospective Registrational study in November of 2019, and made excellent progress over the past 24 months at mist, the backdrop of a global pandemic.
Impact on overall colonoscopy screening procedures.
I am so proud of our team who have worked tirelessly to continue patient enrollment and have kept us on track to hit our HL timeline set back in 2019.
We expect to hit our target patient enrollment in the coming weeks.
Shortly after its target enrollment is achieved we are planning to start running the collective SaaS booking our lap while we continue to collect colonoscopy reports a centralized pathology report does in these cases in parallel.
Expect to have the trial readout.
2022.
True Eclipse our team has developed a core competency is running a large registrational study and I believe this expertise will prove invaluable adds to be mobile and to add this sharp cancer types.
We are also making great progress building, our commercial infrastructure to launch our screening product and are on track to launch the <unk> version of our CRC screening assay in the first half of 2020 two.
We expect to launch the IV would be very shocked the assay in 2023 pending successful FDA review and approval.
Recently, our collaborators at Samsung Medical Center.
Data data at American College of gas transfer all of January scientific meeting.
This was a retrospective study that use biobank samples from individuals with non CRC, whereas areas seven first half <unk> assumed somatic.
And the study researchers evaluate the performance of our test in an expanded cohort of 699 patients with CRC and found that test that achieved an overall sensitivity of 96% are at 94% specificity.
In Asia are in stage, one and two CRC that test offer at 93% overall sensitivity. Additionally, our test identified 90% of patients with symptomatic stage, one or two CRC.
Now looking beyond CRC operates strategy with multi cancer screening.
Our focus is to develop blood based screening for cancers, where it lives can be saved.
Our differentiated core technology platform, which leverages combined analysis of genomic methylation and <unk> maturities redeemed cell free DNA has the potential to detect many cancers at the earlier stages.
We have developed a new generation of our high sensitivity of sequencing assay for evaluation of cell free DNA across multiple tumor types.
This new assay used as a cost target at 16, Megabase annul trains reach cell free DNA at process setup highly informative reach apps in order to detect the presence of tumor derived signals, while maintaining low sequencing cost per sample.
In addition, we also utilize that to genetic signatures to evaluate tissue of origin <unk> are cancer.
We evaluated the performance of the assay and a pilot study using a biobank cohorts of under that 91 treatment nave lung cancer patients.
1576 cancer free individuals.
The assay demonstrated high sensitivity for detecting lung cancer cases for both early and late stage disease, while maintaining 95% specificity.
Our SaaS activity of detecting stage, one and two cancers.
78% and further increased to 93% and late stage patients stage three and four.
Importantly, we all observed even higher performance with sensitivity of 95% for stage one two in lung squamous cell carcinoma cases, which is a more aggressive form of lung cancer frequently found in smokers.
To evaluate the accuracy of our tissue of origin for a big chunk, we havent Bevalaqua classification, hawsehole distinguishing lung cancer patients patients with colorectal and breast cancers.
Overall, the model correctly identified T O or 90% of the excess lung cancer patients.
We are thrilled by our progress in lung cancer screening.
Lung cancer is the leading cause of cancer related death in the United States.
The evidence based screening guidelines re comment the annual lung cancer screening for high risk individuals. However, this screening comps minus steady demonstrate gross under utilization as only around 14% of people eligible for screening are up to date with screening or accommodate.
<unk>.
We believe lung cancer is a great clinical indication candidate prior screening tests.
To validate the performance of our assay in a lung cancer screening cohort, we have designing new prospective registrational study called shield.
Shield is a single arm clinical validation study designed to provide regulatory great evidence for the accuracy of our blood based assay in individuals between the ages of 50 to 80, who undergo as standard of care screening for lung cancer using low dose <unk> scanning.
Aspira <unk> recommendations all subjects in broadband shield will be high risk or Lancaster and either crime.
For farmers small cares.
We are targeting enrollment of nearly 10000 individuals.
Expect to begin enrollment in December of 2021 and to complete enrollment within 36 months.
We believe the promise of blood based cancers screening is quickly becoming a reality and.
And we see a brighter future for humanity by improving population health.
A successful readout of our eclipse trial.
Open up at $20 billion screening operational mechanic colorectal cancer and shield along with other future studies, we will open up opportunities in law again additional cancer types paving the way towards the total addressable screening marked up more than $50 billion.
I am confident about our strategy endeavour looking blood based test for screening market not just in CRC, but allstate multi cancer screening.
With that I will now turn the call over to Mike for more details of our financials and outlook for the remainder of 2020 one.
Thanks, Rami and Robyn.
Total revenue for the third quarter of 2021 with $94 8 million.
Of the 27% from $74 6 million in the prior year quarter.
This increase was primarily driven by strong growth in both the clinical and Biopharma sample volumes.
So precision oncology testing revenue for the third quarter was a record high of $79 3 million with a growth of 31% compared to $60 4 million in the prior year quarter.
Precision oncology revenue from clinical tests in the third quarter was $61 3 million of 27% from $48 3 million for the prior year quarter.
First quarter clinical test volume was 22806, which is an increase of 35% from the prior year quarter.
Blended clinical ISP for the third quarter of 2021, it was $2699, which was above our estimate due to an improvement in the ASP for <unk> 360, <unk>, where the team has done an excellent job ensuring payers were well prepared for the new <unk> code and efficiently process claims.
We are seeing solid traction for our new clinical products reveal tissue next in response and we expect the volumes to continue to increase with time. However, we don't expect these new products to significantly contribute to revenue until we received Medicare and private payer reimbursement thus.
Therefore, whilst we expect carbon 360, <unk> and CTX asps to.
To continue at similar levels, we expect the blended clinical ASP will be impacted as we were reimbursement of the new products.
Yeah.
Decision oncology revenue from Biopharma samples in the third quarter totaled $17 9 million or.
49% from $12 zero million dollars for the prior year quarter.
Biopharma volume was strong with third quarter samples totaling 4839, 58% from the prior year quarter.
We are very pleased with a healthy rebound and we are still on track for low double digit volume growth for 2021.
Biopharma sample ISP was approximately $3700 down 5% from approximately 3900 in the prior year period, but improved from the second quarter of 2021 due to the Omega and garden 360 mix.
Development services and other revenue in the third quarter totaled $15 $5 million.
Of 9% from the prior year quarter.
We are continuing to see strong overall demand for development services.
Several projects have recently been completed or soon to be completed and we expect some near term lumpiness in this revenue line related to the timing of project milestones and other contractual arrangements.
As a result, we expect that our development services and other revenue may be sequentially lower in the fourth quarter and as new projects take time to ramp up this is likely to persist into next year.
Gross profit for the third quarter of 2021, with 64 zero million dollars compared to a gross profit of $53 4 million.
In the same period of the prior year.
Gross margin was in line with our expectations and in the third quarter was 67% compared to 68% in the second quarter of 2021 and 72% in the prior year quarter.
Operating expenses for the third.
Quarter of 2021 were $171 3 million an increase of 34%.
That's a $127 6 million in the third quarter of 2020.
Non-GAAP operating expenses exclude stock based compensation and related employer payroll tax payments acquisition related expenses amortization of intangible assets and changes in fair value of the contingent consideration.
Non-GAAP operating expenses for the third quarter 2021 by $135 1 million and 88% increase from $71 8 million in the prior year quarter.
2021 has been a year of significant investment and we expect operating expenses to continue to accelerate for the remainder of the year as we invest in our lunar program Eclipse study and other development activities and in our screening business as we prepare for the planned launch of the LDC version of our CFC screening assay in the first half of 2022.
Net loss was $107 5 million or $1.06 per share for the third quarter of 2021.
Third to $77 7 million or <unk> 78 per share in the third quarter of 2020.
Non-GAAP net loss was $70 5 million or <unk> 70 per share for the third of course of 2021.
$15 4 million or <unk> 15 per share for the third quarter of 2020.
Adjusted EBITDA was a loss of $65 2 million in the third quarter of 2021.
At September 30 up in 2021 weeks.
We expect to complete the purchase before the end of the second quarter of 'twenty to 'twenty two.
Now turning to our revenue outlook for the full year 2021.
We continue to expect revenue to be between 360 and $370 million representing growth of approximately 27% over 2020 at the midpoint.
We experienced some COVID-19 related impacts the clinical volumes during the third quarter with respect to field service access to oncologists and tighten restrictions internationally.
We saw recovery in September and into October as compared to a relatively weak August.
But continue to see an impact on calls yesterday.
And Salesforce access in the U S and across our global business.
While we expect clinical volumes to growth compared to this quarter.
We continue to be cautious given the uncertainty around the impacts of COVID-19.
Despite this we are expecting quarterly clinical volumes to finish the year strongly and grow approximately 40% year over year in the fourth quarter of this year.
We've made great strides this year as we continued to broaden our oncology product portfolio and expand our reach into the cancer screening market.
We're aggressively pursuing the best opportunities ahead, and we have come.
And that we will that we will be a leader in cancer across the continuum of care.
At this point, we will open up the call for questions.
Thank you we will now proceed the Q&A if you'd like to ask a question you compress star one on your telephone keypad. If you would like to withdraw your question you can press star two.
These 19 will only be taking them one question and one follow up from each person Mike King.
Our first question today comes from Puneet <unk> from SVP Leerink Puneet. Your line is now open.
Hi, Thanks for taking the question so.
Theme, so far for a patient that's a half finished a colonoscopy and we have to ask a few reports and their CRC where confirm.
And based on all the data that'd be a shame, we felt comfortable that actually be needs to increase the enrollment target from 10000 to 13000.
And same spend C O R prevalence in CRC incidents to remain the same so we believe based on all the information we have right now.
Feel very comfortable that 13000 is the right target into all of them just cause I found out obviously comments about other companies trials.
But you know probably actually maybe what's giving experienced this.
Maybe how well this sidesaddle beams satellite bed or the trials once they expect the prevalence of C. R scheme do you find a location you friend G. O. I think there are a bunch of factors there that potentially health guard that you as you may remember during the early days of Covid.
In fact, we doubled down on our screening spending instead of throwing just down on during those days in fact, we last Saturday shapes or some additional I tripped protide prevalence kind of sightseeing far study.
But yeah, I know well or did they did that we're seeing at garden.
That's that's a townhouse comments about other trials out there.
That's great and they're very helpful and for my follow up I know, it's early you talked about the green burst mend <unk> for the shield trial or the shield assay wanted to merge is out of the trial, but could you maybe just talk about where potentially how are you thinking about.
Sort of a pricing of this assay and what is the regulatory pathway here and the guidelines inclusion pathway that you need in order to get this a screening test on to the market. Thank you.
Yes, I'm in line screening site that has been something that'd be very well studied during the last couple of years and always the criteria that'd be used for selecting our next send indication as Maltese bacteria nights create a biology technology, but also reimbursement Afghan regulate trade pathway.
Eclipses like one kind of a steady.
Are there kind of.
Analysis by a bank studies could really complicates the.
Yeah sure their performance out of your guys seen eclipse, we don't need to do this perspective, two years steady sample collection of eclipse and run it.
Having said that throughout the years actually since 2019, we try to.
De risked that technology on our assay in the cohorts that 10 minutes as closely to the screening population that we're kind of I guess, an eclipse I think the closest although it's not exactly the same.
The closest or do you assume some average patients with early stage CRC that you know you're basically seeing the performance of our assay.
You talked about the limitation out those data definitely we are very excited actually thrilled with the performance of our assets and we are.
And I'm very optimistic about what we're gonna seen eclipse, but.
According to the comments I always mentioned it eclipses the eclipse so you'll have to just wait.
Very few months away from really getting this data from eclipse all the signs that we are seeing so far in general gives us a lot of confidence, but we have to see what eclipse, there's gonna have crossed it yet whether it'd be around that cohort.
Okay, Great and then as a follow up.
Monitoring the job posting sites.
You guys are clearly building organization in advance of.
The launch of that product as you know the team next year can you just give us any idea about the type of sales force that that youre looking to have here size be qualifications, where you're gonna be getting people from.
Any kind of information on that I think would be helpful. Thank you.
Yeah, absolutely so.
We're very excited about actually 2022 you know, it's gonna be a year for us that we are kind of.
Go after a bunch of market shaping activities really our goal is to do the right investment that once we have FDA approval in 2020 three if we can maximize the mark that adoption at that time.
And we are building.
Sales channel that accordingly.
Objectives that we have in this market shaping phase of our commercial base.
It ranges from engagement to be a bunch of high value stakeholder in that can basically helped set the right framework for blood based screening to be used in proper way in health Sistema also.
A bunch of early adopters on the PCP side.
Also we are gonna engaged heavily with bunch of health system and.
Try to get a bunch of engagements widened we are really.
Post LDC validation of our test to really integrate the blood based screening assay into procedures workflows and.
Systems that these health care systems.
So that would be our activity in 2020, two I know you're kind of drop appropriately investments about sizable commercial channel to really go after those opportunities for us.
Sure.
Yeah.
Yeah.
Okay. Thank you Brian our next question is from Derik de Bruin.
From Bank of America Derrick Your line is now open.
Hi, good afternoon.
Just.
The first question I think is on the O U S expansion, I mean, youre, making some big pushes into Spain, the U K.
And obviously, there's the the JV purchase how should we think about the particularly in the in the Spain, and UK situations, where sort of the volumes.
You know what.
Liquid biopsy with UE now with volume through there and how do you sort of think this changes the utilization going forward and and when do you see the O U S revenues becoming material.
I think I don't think that for the question.
We did have you made any performance improvements the test again I'm just trying to think about how this translates.
To the prospective data.
Yes, sure I shouldn't cohort discuss resenting a C G by our partners and SaaS <unk> Medical center to expand it.
As more data gets generate so that feeds into our algorithm decides not to do the training.
Based on more.
I know samples representation of all kind of smaller sub population.
And in theory, you kind of expect maybe spare farmers gifts.
Better slightly but bigger market I think from my perspective.
Got it.
As a follow up there were some headlines in the quarter around M&A I was curious if you could just weigh in on your thoughts around continuing to forge ahead with the organic strategy versus maybe the benefits of doing something you know in terms of the terms of more of a big deal.
Yeah no. Thanks for the question.
We have a extensive team was built.
Around the corporate development, we obviously have a lot of cash in the bank.
You know I think we'd like to use it for something that makes sense potentially but.
As you mentioned our bar is very high and we are very excited about the organic opportunities we have peanut butter pipeline.
The progress we.
We're making with lunch.
A whole host of products over the last 12 months into the market and have obviously, some pretty breakthrough products are planned.
So they're coming.
Quarters in years, and so the bar as I.
Understandably very high.
Capex through the year has been has been well planned out and tried to year.
Dan to increase.
Size of the commercial team on the oncology and we mentioned that Thats.
Now at over 250 people, so thats more than doubled.
In the last 12 months and.
And as we come in towards the backend of the year and into into next year.
We start to build the commercial team on the on the screening side getting ready for the <unk> launch so commercially.
Commercially.
That's been really the driver of our Opex increase this share I think we will do going into next year on the.
On the research and development side, because that's also been a big driver of the increase on Opex.
We've got ongoing studies with eclipse, we announce here now.
Oracle study and the <unk> studies that are commencing so there'll be they'll come into factor.
Next year, and then we continue to innovate.
And develop new products and again, we launched three new products. This year. So we're continuing on that spend so we expect research and development spend also just to continue to to drive those initiatives next year.
On the personnel piece.
We're not breaking that out specifically on the percentage, yes, I mean, we've obviously seen that increase and again I mentioned that the additional.
People in the on the commercial on both oncology and non screening so that's becoming.
As a grower for us and we're investing in people and growing the size of the organization. We're also building out the infrastructure of the business as well. So yes. That's also a driving force for Opex increase.
Great. Thanks, very much I'll hop back in the queue.
Thank you Matt.
Next question comes from Patrick Donnelly from Citi. Patrick Your line is now open.
Thank you maybe one for you just on the on the volume side. It sounds like September and October recovered pretty nicely from August I think you are talking about 40% volume increase in <unk> can you just talk about the cadence as we went through the quarter and even even in October youre confidence level things are stable to obviously pointing up.
Here as we enter into 'twenty, two just trying to get comfortable with the volume piece. It sounds like you guys are a little more confident relative to last quarter certainly.
Yeah no. Thanks for the question.
Yeah, I think I think the good news was some of the early learnings.
I think in the last call.
Of of patients and so you know it'll be it'll be a sizeable amount open that spoke spend over the next few years and it's similar level to eclipse, but yeah. We went up sort of breaking out each individual's study, maybe and given those costs.
Understood that's correct.
Thank you Patrick our next question is from Julia Quinn from J P. Morgan Julia Your line is now open.
Hi, Good afternoon, just a follow up I'm gonna be all I know, you're not ready to quantify the the volume contribution in a corner, but just qualitative me you know it's reveal uptake sofa, mainly within Biopharma users are you see equal attraction for clinical customers and I was still expecting L. C D touch by.
O N.
The last case, Yeah, I think we are.
This is taylor expectation.
As it pertains to reimbursement I would say it for.
I guess a couple on Biopharma volume from me.
Volume trends appear to be looking very strong, but I was wondering if you guys can benchmark what youre seeing in terms of sample volumes.
Relative to pre pandemic levels and what is your backlog the backlog of work looking like heading into 2022.
Great.
Yes, it's Mike here.
I think we're sort of recovering now from the from the depths of the.
The pandemic impact.
We're back to levels, where we were before that and we as we forecast going out.
Towards the end of the year I think we just see that rebound.
Getting stronger and stronger so.
No thats very positive frozen I think Mexico.
Pandemic levels.
And in terms of backlog of work heading into next year can you give some color on what that looks like.
Backlog of work.
We don't generally break out a dollar value of that.
But I think.
That's changing that and there's no there's no real trend to look at I think it just fluctuates on a quarterly basis.
Got it thank you very much.
Thank you J P. Jess on next question comes from David Western but from Guggenheim Securities. David Your line is now open.
Hi, Thank you for taking the question. So I wanted to focus on the comedian Oncologists you you highlighted the growth. There are there any initiatives are there that you want to highlight and then as we look to the next three to five years. What do you think the magnitude of growth is going to is going to be in the community oncologists versus the academic setting.
And that's all the questions I have.
Alright.
When you say when you think about how the market is.
As a segment, that's often thought to be about 80% in the community are mixes are well over I think 60% community known so theres more growth.
To be had there so that's certainly an area of focus for us.
I think there are a number of reasons why I think we're doing well there because you just need a critical mass to be able to.
Yes.
Really the.
Distributed nature of the community setting so we've really expanded the commercial team over.
In the last year, and especially with the launch of reveal.
It's not just the commercial team, but it's also the medical affairs team that is very critical of them really having.
That.
Those genomic specialists and medical.
Partners to be able to help with interpretation of results and feedback on test reports and so that's something that we invested in a very early on.
Investing as well and then finally, it's the service offering really being able to provide.
Customer service experience, a white glove service.
It's being utilized and so you know again the the volume that we're seeing we're very pleased with and and it's in line with our expectations, but again you know we have this now multi multi progress on the clinical side Uhm and wind up breaking out the volumes, but we said that you know the the main.
Growth driver photos continues to be gone through 60 L. B T C D X and from a revenue perspective, you know the vast majority of our revenues coming from those two seven fully reimbursed permits.
Got it <unk> Oh, I guess, maybe cause final question time Uhm, how do you thinking about like the market share at that's plain any <unk> with a lot of players just one I can't get a sense about how do you think you'll probably market dynamics. Thank you.
Yeah. That's a good question in terms of all the matrix you could try that.
We believe it's never really been in a better position than we have now you continue to make great progress. We think we have great.
Foreman from assured voice perspective, and we continue to invest you know not just in a narcotics but.
The commercial offering a commercial channel as well and we feel very good and all of the areas that we can today and we were.
Going to continue to invest more as we have is if you need to have success.
Thank you.
Hi, Thank you Blue final question comes from my <unk> from Stifle Diane Your line is now open.
Hi, guys. This is <unk>.
Daniel May shut down for Dan artists.
First just a clarification, primarily I think I heard the <unk> is expected in the first half of the year I I just wanted to make sure I heard that right and and if so I'm just curious if there's a possibility that reading out sooner.
And then for Mike on F. PS the <unk>. The expected are you expected <unk>, what am I trying to say the bun it averages lower what's the new products, but is your expectation that the issue with the private payers and that new radio P. Code is largely works through I know you mentioned you said that you chose a working on.
On that so I'm, just trying to get a feel for it maybe that's something that is less of an issue going forward.
Okay. This is I'm gonna ask starting first first question so.
Those issues.
Very strong SBS.
Okay I appreciate it guys. Thanks.
Thank you Dan that concludes the Q&A session for today. Thank you for joining today's call you may now disconnect.
Okay.
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