Q3 2019 Earnings Call

Good afternoon, ladies and gentlemen, and welcome to the guarded held the Q3 2019 earnings conference call.

This time, all participants on eight listen only mode.

Later, we will conduct a question and answer session and instructions will follow at that time, if anyone should require assistance. During the conference. Please press Star then zero on your Touchstone telephone.

Reminder, this conference is being recorded.

Now I'll turn the conference over to your host Miscarry Mandeville. Please go ahead.

Thank you.

Earlier today ardent health released financial results for the corner and at September Thirtyth 2018.

The have nots steep news release, where he'd like the out into the company's distribution list. Please send an email to investors at garden help dotcom.

Before we begin I'd like to remind you that management will make statements. During this call affords me statement within the meaning of federal Securities laws.

He was involved material risks and uncertainties that could cause actual results or events to materially differ from those anticipated.

That's not information regarding these risks and uncertainties Pearson section entitled forward looking statements in the press release Garden issue today.

A more complete list and description. Please see the risk factor section of the company's annual report on Form 10-K for the year ended December 31st 2018, and other filings with the Securities and Exchange Commission.

Except as required by law garden disclaims any intention or obligation to update or revise any financial projections or forward looking statements, but there because if you look amazing.

Or otherwise this conference call contains time sensitive information and it's accurate only as of the life broadcast remember 70090, but that I'd like to turn the call over how many oaky ardent co founder and CEO Tony.

Thanks, Gary and thank you everyone for joining us this afternoon.

I'm pleased to welcome you to Garden Holdings third quarter 2019 earnings call.

Joining me today is a mere only tell a SaaS president and co founder and Daryl Byrd Tachy, our Chief Financial Officer.

Consistent with our values are putting patients first I will start OCO with a patient story.

A decade ago 69 year old position was diagnosed with page two prostate cancer by 2018 is cancer had become metastatic and was progressing despite an androgen deprivation therapy.

With a rising PPSA score an unpleasant side effects for MS therapy. He discontinued treatment close this private practice and began making end of life care decisions.

Looking for another option because I'm color just ordered a garden Threesixty test.

Quick we identified a somatic rocket two mutation is dr. immediately started them on a PARP inhibitor therapy, which has demonstrated promising data in BRAF mutated prostate cancer.

Nine months later this basin is alive stable that good work once again caring for his patients.

We believe this story demonstrates the growing importance of the precision medicine paradigm in oncology not just for lung cancer patients, but increasingly for patients across many cancer types, establishing a new standard of care for patients. However is not simple and requires generating evidence of superior clinical utility to so.

Gordon broad reimbursement, then clinical adoption for such new approaches.

And garden hose, we're committed to such investment aimed at advancing clinical utility across the continuum of cancer care.

In the treatment selection market for example, with garden Threesixty, we missed refocused our efforts in non small cell lung cancer will be believed the limitations of tissue created a critical gap and comprehensive testing through investments in high impact clinical studies were able to quickly established clinical utility in lung cancer, which in turn as home.

<unk> decreased I'm to reimbursement approved position conversion efficiency and lead to record clinical adoption.

Investments along with our many collaborations with leading cancer centers and pharmaceutical partners have led to over 130 peer reviewed publications in over 400 scientific abstracts detailing clinical evidence supporting our platform across dozens of cancer types.

For instance, at the reason European Society of Medical Oncology Conference in September results from the trial study demonstrated that patients with metastatic colorectal cancer, where they hurt to amplification detected by the garden Threesixty out say experienced clinical benefit from her two directed combination therapy. These results strong.

We suggested the garden through six can identify patients with her to amplified metastatic colorectal cancer, who could benefit from the dual her to targeted therapy.

As we have mentioned previously in addition to strong clinical data, we believe FTC approval of garden Threesixty will be an important catalyst for helping to establish a blood first paradigm that will lead to continued clinical adoption of garden Threesixty.

Over the last two years, our team has been working diligently on analytical and clinical validity studies to support a premarket approval application for garden Threesixty and what do we believe would be the first if its kind submission.

Today, I'm happy to announce a very important milestone for the company and for the precision oncology space and that we have recently submitted our P. M. A package for garden Threesixty to the FDIC.

We also believe that a final Medicare pancancer LCD could be issued by the end of the year.

As a reminder, this LCD could potentially expand Medicare coverage of the garden Threesixty assay to over a dozen advanced solid tumor cancer types with guideline recommended genomic target.

These tumor types represent the vast majority of all solid tumors. The draft LCD applies to advanced cancer patients who are covered by Medicare for next generation sequencing of tumor tissue, but have insufficient are unavailable tissue samples. This is an important step towards ensuring all Medicare beneficiaries.

With advanced cancer have timely access to guideline recommended treatment options.

We are encouraged by the increasing demand for products and in particular garden omni from our Biopharma partners Darden Omni offers our partners the upper opportunity to identify patients who may respond to immuno oncology agents as well as targeted therapies. For example, an area of growing interest is identification of.

Patients with homologous repair deficiency gene signatures, who may be candidates for a classic targeted therapy known as PARP inhibitors.

The continued robust progress across every segment of our business translated to another exceptionally strong quarter with total revenue growing 181% year over year to 60.8 million.

Over the same period clinical volumes grew 89% to 13259 clinical tests and biopharmaceutical volumes grew 111% to 5280 tests.

As a result in this progress we now expect revenue for 2019 to be in the range of 202 to 207 million, reflecting growth of 123% to 128% over 2018.

Before I turn the call over to a mirai to discuss the details of our lunar programs.

I would like to mention that Eric allele has stepped down from our board of directors. Following his departure from Sequoia capital.

I wanted to take a moment to thank hours for his guidance and contributions to garden over the past four years with that I'll now turn the call over to Mirror Ali.

Thanks tell me.

Similar to our clinical development and commercial atrophy card entries 60 in starting with lung cancer and lead indication. We are taking a similarly focused approach with our new on their programs.

Starting first with our don't ever one program, where we are developing an assay or I should not terribly decision, making and Chris.

We believe that's abolition evidence for clinical utility is it really is a critical components that drive sustained long term adoption endeavoring, France monitoring space.

One of the challenges have used space will be did demonstration of clinical utility to prospective interventional trial.

That is proving that earlier detection operators, each odcs or recurrence and lead time improving patient outcomes.

We believe this will be critical to changing cleaning those as ambitious reimbursement on a variety of payers.

So this AD I'm very pleased to announce that we have clinically validated our donor one assay and launched a CLIA waiver of this assay for prospective clinical trial.

In addition, we are planning to initiate a prospective interventional study for asthma therapy selection in colorectal cancer.

Linear future.

Now moving onto it on there too.

We've been diligently advancing our colorectal cancer screening program forward, where we believe that lot based assay, which adds tremendous value when looking at a thing rates of patient compliance with at the end of both screening.

A few weeks ago, we announced enrollment of the first page.

Our eclipse study.

This is a prospective multi site Registrational study designed to support the introduction of our known her to assay for use in guideline very common that colorectal cancer screening average risk at all.

This study is primary objective is to evaluate the performance of the no there to assay to detect colorectal cancer.

Asia specificity hearing screening.

The study all saying food secondary endpoints evaluating the assay activity related to call. It.

Over the next 24 must be plants, we enroll about 10000 individuals aged 45 to 84 or an average risk rectal cancer across about unread sites in the United States.

To our knowledge. This is the first blood based screening trial of this magnitude.

We are encouraged by our early discussions with both FDA and CMS and believed that if successful. This rig late threeq rates steady will aid that way or yeah argument there to assay.

Late here, yes coverage.

Both of which are critical for durable line true Fannie call.

We're very excited by our IP progress as well as the positive reception, we continue to receive from importance stakeholders in this space.

Yeah I agree there is a critical gap in the screening landscape for colorectal cancer, which is known to be FX, even saving lives.

In fact, the U.S. prevention services ask for three comments screening average risk at all for colorectal cancer, starting at age 50.

True age 75.

Yes.

Despite the guidelines and establish clinical evidence about one fair enough adults in the United States, we should be screen do not comply citing that <expletive> Ryan screening methods, our time consuming and.

And in case of Oscar invasive.

Our blood based assay is intended to improve screening compliance by removing barriers associated with right testing methods.

Because blood tests are ready play on him take all enrolled in medicine, we believe our test could significantly increase at year end speed screening guidelines.

Field, Oh, I am yeah that exist today.

I look forward to building the clinical evidence needed I mean should section of our assay commercially and drive planning cloud adoption.

With that I will now turn the call over to Derek very touchy or more detail on our financials Derrick.

Thank you were merely.

Revenue for the third quarter Threenineteen totaled 16.8 million.

181% from 21.7 million in the prior year quarter.

Third quarter revenue included 5.5 million due to payments received in the quarter from successful appeal of payers denial of reimbursement for samples processed in 2018.

Given the of the samples associated with the successful appeal.

The company does not leave this appeal revenue is indicative of ordinary course upgrades.

Increases in both volume and ASP for clinical testing.

Higher volume for Biopharma testing with the prime drivers of the increase in revenue.

Development services, primarily companion diagnostic programs also contributed to the increase in revenue.

Total precision oncology revenue in the third quarter with 52.1 million.

185% from 18.3 million in the prior year period.

Precision oncology revenue from clinical tests in the third quarter totaled 30.8 million.

244% for 9.6 million in the prior year quarter.

Due to increases in both volume and his team.

This included the 5.5 million of revenue from appealed the 2018 Sam.

Third quarter clinical precision oncology volume totaled 13259.

Up 89% from 7000 BOE 27 in the prior year quarter.

This increase was mainly due to reimbursement by Medicare.

Lung cancer patients starting in the fourth quarter 2018, plus increases in commercial payer payments that were beneficially affected by the protecting access Medicare Act of 2014.

Precision oncology revenue from biopharmaceutical test in the third quarter totaled 21.4 million.

145% from 8.7 million in the prior year quarter due to growth in the number program biopharmaceutical customers brought to garden.

Particularly for use of Gardened Army.

Third quarter biopharmaceutical precision oncology bullet volume totaled 5280 pent up.

111% from 2505 tests in the prior year quarter.

Average revenue recognized per biopharmaceutical test in the third quarter was $4052.

10% from $3491 in the prior year quarter.

Due to a greater number of carton omni test, which has a higher selling prices and garden through 60 test.

Development services revenue in the third quarter totaled 8.7 million.

156% from the prior year quarter due to an increase in projects from biopharmaceutical customers active in 2019, mainly for companion diagnostic development and regulatory related services.

Gross profit is total revenue less cars to precision oncology testing and cost of development services.

Gross profit for the third quarter 2019 was 42.3 million compared to a gross profit of 11.6 million in the same period of the prior year.

The gross margin in the third quarter was 70% as compared to 54% during the third quarter 2018.

These results are inclusive of the benefits of the 5.5 million Appeals revenue.

Gross margin improvement was primarily due to the increased average revenue per clinicals and biopharmaceutical test.

As a reminder, effective January 1st 2019, we adopted a new revenue accounting standard SP sixes.

Using the modified retrospective method, which means revenue reported for 2018 is not restated in our 2019 financial statements.

Instead, the accumulated difference, resulting from applying the new revenue standard to all contracts that were not completed at the adoption was reported to opening accumulated deficit as of January 119.

The effective the adoption of SP six effect was to increase Q3 revenue by 1.1 million compared to the revenue would have been reported without adoption of six effects.

The effective this change is disclosed in our Q3 results press release.

Total operating expense for the third quarter 29 team was 59.8 million.

67% increase.

35.9 million in the third quarter 2018.

R&D expenses for the third quarter 2019 were 24.6 million compared to 14.3 million in third quarter 2018.

The increase was primarily attributable to work to prepare the garden Threesixty IBT submission to the FDA.

Development and clinical studies for the lunar program.

And additional clinical studies improvement our new products.

Sales and marketing expenses for the third quarter 2019 were 18.8 million compared to 13.5 million in the third quarter 2018.

The increase was due to expansion of our commercial organization to drive increases in revenue.

General and administrative expenses for the third quarter were 16.4 million compared 8.1 million in the third quarter 2018.

This increase was primarily due to increases in personnel professional services, including legal and accounting.

And costs required sports transitioned to a public company.

Net loss attributable to garden of common stockholders was 12.8 million compared to 24.5 million in the third quarter 2018.

Net loss per share attributable to garden common stockholders was 14 cents per share in the third quarter 2019, as compose as compared to $1.94 cents per share in the corresponding period per year.

We ended the third quarter 2019, with 825.6 million in cash cash equivalents and marketable securities.

As Tony mentioned, we are updating our revenue guidance.

For the full year 2019, we expect revenue to be in the range of $202 million to $207 million.

Representing growth of 123% to 128% over 2018.

Our previous revenue expectation was 180 million to $190 million.

We now expect clinical sample volume for 2019 to be approximately 48000 test compared to our previous expectations of 44040 6000 clinical samples.

We now expect net loss in the range of $75 million $80 million compared to our previous expectations, a $112 million to $115 million.

This estimate includes costs associated with the start of our clinical trial in the fourth quarter 2019.

With that we'll now open it up questions operator.

Ladies and gentlemen, if you have a question at this time. Please press Star then the number one key on your test time telephone. If your question has been answered or you wish to remove yourself from Q. Please press the pound key.

Our first question comes from the line of Brian Weinstein with William Blair. Please go ahead.

Hi, guys. Good afternoon. This is actually Andrew Brackman on for Brian maybe we can just first start off with high level question around adoption of GE Threesixty, what you're seeing there what sort of institutions from a high level, our are sort of the ones, where you're getting that people sort of penetration is that an academic hospitals large I'd enter community hospitals, and how does that compare to what you had thought.

Before in the year. Thanks.

Yes, good question under.

So we're actually seeing pretty similar trend to what we've been seeing for last few quarters.

You know with Nile was expanded sales force and well I think some of the clinical data that is giving more confidence to use of liquid biopsy for biomarkers selection.

We're seeing you really a shift from.

Our penetration and academic centers to no really robust growth on the community side and so historically.

Years ago had been weighted on the academic side and now.

I think.

Just about 60% of our volume is in the community and that's where we're seeing I would say the.

Fastest growth right now of adoption, which is where you want to be because you know about 80% of oncologists backed us in the community setting.

Got it thanks, and then just one on guidance as we sort of think about.

The last sort of several quarter very obviously blown away sort of the consensus expectations. How should we think about you guys. What's what are sort of puts and takes in order to get to that low end of the range and then one Derek are there any other additional onetime payments associated in that guidance. Thanks.

So in the in the guidance there are not expectations of any onetime so you should be thinking about.

You know the the revenue in Q3, excluding that as you think about looking forward.

In terms of the guidance, we think that this is the.

Prudent guidance relative to what our expectations are we had indicated at the outset of the year lease.

Reminded the analysts that.

Our pharma business would be heavier in the first half.

And where we're seeing that exactly in the results, we still see that our pharma business in terms of programs that pharma customers, who bring to us is very robust.

We just had a bit more of their activity happened in Q3.

Then were.

Than we originally anticipated.

Thank you.

And your next question comes Juan Tyco Peterson with JP Morgan. Please go ahead.

Hey, Thanks, Nice quarter question, I guess, it with the Palmetto LCD getting finalized into year end, but then you've got the NCD coming in the first quarter.

Is the Palmetto LCD effectively move once once the MTD roles and or whats important is actually getting that in place.

Yes, so we look at the two areas.

Really thurlow kind of pathways in terms of.

Securing pancancer Medicare coverage and so.

I think it's nice to have the optionality of both pathways in terms of being able to.

Secure would we believe is going to be the largest step function and ASP increase for our clinical volume.

And so we believe the LCD should get finalized later.

Later this year.

NCD, we believe that will be kicking in.

Essentially.

Probably a quarter after.

FDA approval of.

Garden Threesixty.

And so and the than the review cycle is informally six months from.

From submission so.

We certainly think that the LCD would be something we can draw on well before the NCD.

And then how many are you able to talk on progress within Japan, JV other kind of milestones, we should be paying attention to over the coming quarters there.

We continue to make excellent progress there, we're seeing now thousands of samples that reprocessing in Japan.

As well as in southeast.

Asia, and so joint venture with Softbank.

Continues to make good progress we believe our FDA package is important not just in the U.S., but internationally since it's that data that will be used in our submissions to other regulatory bodies, such as the PM da and so the team is working diligently on some of those activities.

Translating that work into.

The form factor required for.

For the PMD in Japan so.

I think I think probably nothing specific to update at this time, but we're very pleased with the progress.

And then on on CGP comprehensive genomic profiling, that's been stuck at around 15% can you just talked to what it takes to move the needle there.

You mean in terms of penetration into.

Yes, it will from what we can estimated the 15% to 20% range in terms of tissue or liquid comprehensive genomic profiling penetration.

I think we are seeing as more targeted therapy is become available.

Obviously, the NCCN guidelines have been updated from just a few markers to now eight biomarkers for NCCN lung cancer, we saw Pixthree CA.

Recently added.

As an option for breast cancer patients and so.

It's going to take this this multifactorial effort to I think move the needle to.

Really ensure that.

The comprehensive genomic profiling is done.

For newly diagnosed metastatic patients at the first line setting and so the good news. There is I think we are seeing that move on we're seeing that needle move and it's not just us that is.

Is.

Putting the effort and it's.

Really the whole space and all the pharmaceutical companies that are.

Selling into that market are are helping as well so yes, we're very confident that.

That's going to continue moving in the right direction.

Okay, and then one follow up.

Mentioned Softbank before obviously a lot of people are focused on their ownership are you able to talk to your dialogue with them.

Your interactions, obviously, there's fear they'll come back to market.

I can tell you the board level.

I think.

Everyone is very positive about gardens in future.

You know prospects from the space, but we can comment on any individual investors holdings.

General.

Understood. Thanks.

Your next question comes on line of Doug Schenkel with Cowen. Please go ahead.

Hey, good afternoon, guys and thanks for taking my questions.

Maybe just a quick follow up to one or tyco's questions on the submission to the FDA the Pmeight package.

Sounds like the answer so both of these is yes, but just to confirm our you officially pursuing all the dual path process and based on what you submitted to the FDA is the expectation that this will support a pan cancer label without any requirement for insufficient gesture.

So.

I got really here so what we believe it based on getting traction that we have.

Greg races.

CMS is we don't needs to go through.

Separate parallel review cycle, our entry 16 ours benefits from Ngs at Citi.

We just need to get the FTC approval and ill have.

I hope, which matches the coverage criteria, <expletive> Ryan and GSS.

So essentially changes there that entry the impact.

Our test.

And regarding like two streams sufficiency are not yet that's the right languages are draft coverage policy.

Palmetto.

For FCD integrating believes on the final label that we can get.

Hey post approval assets it is squarely comments.

The impact of assay that issue.

Additionally, the right okay.

Okay. That's helpful. Thank you for that.

So this this was clearly another great quarter.

On multiple fronts, I would say, especially on the clinical side, where you had great sequential and year over year growth.

Anything special to call out there or is this is this really just continued execution and follow through on Nick and and the more efficiency with the expanded salesforce.

Yes, I think we're continuing to see some benefits from Nile from the sales force expansion and so on but I think as we've communicated in the past.

Surely get too.

I would tell us is as the market, it's really going to require the the three pieces now we have.

Under our belt with this FDIC submission hopefully we'll have soon if they approval and then would the LCD, we should have the that pancancer reimbursement and so.

I think we've been we've seen probably better than expected uplift.

In advance of some of those those factors but.

No I think the good news is.

We're we're kind of swimming and where the rivers flowing so to speak clinical comprehensive genomic profiling is becoming more and more something that is a requirement for for advanced cancer patients are test garden 360 is really the simplest way for physicians to give that information and the quickest way.

And so.

I think what you're seeing is there is some of the obviously investments we've made but.

The fact that.

We're in the early innings of large market opportunity.

Okay. That's great what one last one I Miss listed in the prepared remarks, but I don't think I heard any update on covered lives again, I apologize if I missed it.

I think you guys are around 160 million last quarter and any update at this point.

We continue to add.

Plans small plan here and there, but I would say no no substantive update at this time.

Okay. Thank you again.

Thank you.

Your next question comes on line of Derik Debruin with Bank of America. Please go ahead.

Hi, good afternoon.

Hey, Thanks, a couple of questions.

One great to hear dish and committed gardens restricts the FDA can you give us.

So the timing on that will take the pmeight some summits in the six to nine month range.

So.

Yes, we have greater devices National guard entries.

Thanks.

But review process is gonna be like six months instead of nine months.

Having said that like the asked and go through this review cycle and see how that cycle goes in terms of back half.

And maybe different questions asset there.

Yes.

As we make more progress there would become more.

Obvious for us what would be the timeline for the capital as I mentioned typically for breakthrough devices.

I'd like six months.

Great.

On the equip study enrolling now 24 months time, I guess any sense from when you would have first.

Before sort of look at data coming out and just a couple of questions on.

You.

As you already walk down the out say and everything ready to go and started analyzing that as of now.

Yes so.

You know that plant as actually.

Enrollment tick up to 24 months, maybe shorter than that once you got this apples.

Brian .

You have a package of sub.

Evidence that we have for FDA review.

Getting came after evolves equip stays really are designed to be at rig rates for great state for us.

In terms of assets, we match add here like the technology that we presented our pilot data is basically the same thing that stays the same thing VR in that.

Hello.

Product development of that assay, which meant just making IVC version of that asked a similar process that guard entry to 60 last year, we have got entries technology for line.

IBT version of it you have to go through some process.

Hi itself that news as diabetes so.

We are in that process for no other yeah, a lot of shale last patient.

Yes.

Okay.

We believe we can use it I mean those timelines.

Maybe verizons assay ready to run back.

Great and then just one final question for Derek.

By this quarter by R&D was way too high and my.

I see is actually my estimate with waste behind my R&D was way too low this quarter bonds modeling can you give us since our guidance on the trajectory for both of those robots Opex lines.

So as as you can see with our guidance, we're assuming that we continue to.

Grow our activity. So I think if you if you use Q3 is a baseline.

There would be increases.

R&D as we continue to pursue the lunar program, both development and the clinical trial, which has now started enrolling so that should go up.

We would expect to see some modest increases also on sales and marketing as we are continuing to try and.

The increase our efforts there and we will be adding some.

Reps to increase our efforts there.

I think the bigger figuring piece would be an R&D.

Thanks.

Your next question comes at a lot of Mark This story with Canaccord Genuity. Please go ahead.

Okay.

Congrats on a great quarter.

A lot of a lot of my questions have already been answered, but one settle nuance of CRC screening.

You know exact sciences is enrolling patients beginning at the age of 40 enough. Then I believe a clip is looking for 45 to 85 I recognize this is a subtle nuance given the size of the market, but just any commentary around just that age cut off.

Whether its age 50, 45, or 40, and how you may address potentially a lower each market in the future.

So you know extra.

So the details of this data is put together it was after consultation with.

Yes, we believe actually to.

Study that we are doing.

Would be a baby so say for F basis, Arctic cat dividends.

Although paving the path for getting math for both for it.

40 to 45, it's something which is not on this vote for eclipse that at that moment.

Yes.

Comment on that.

Other companies not quite there right.

Yes, it's also thats a moving target you see as many of the difference.

Yes.

Agencies, and so on an groups have different age recommendations in terms of what they believe is.

I think.

Viable and beneficial from population health plan to view and so I think that's probably something that's going to continue to be a moving target I think is the space evolves and something that we're going to continue to track.

Great and then on the winner one obviously you've talked about the clinical validation.

For research use.

Yes, you also talked about initiating a prospective agitation study for colorectal cancer I guess, what I'm really trying to get added when do you expect to watch lunar one for the clinical monitoring and do you intends to initiate the monitoring in the clinic out with colorectal cancer initially.

So as you mentioned the remarks, we believe there are some work.

That's needed to be down the fields, which Eric additional clinical utility data to show Thats really looking at the.

Ambridge Otcs indifferent Astra types with sherritt patient outcome benefit.

We decided clinical over the asked David share very excited but with this development on the progress our team may and initiate a major prospective interventional study that based on what we buy into a lot do something that frankly on the patients and show what would be the outcome.

Benefit for patients. We believe this is the right next step in terms of.

You are going to access for our main incorporate test for clinical testing in markets still.

Todays comments.

Great and maybe on the commercial side I know, you've you've made a significant.

And your Salesforce this year.

But as we think about a really large market only roughly 15% penetrated I think there is at least one other CGP lap company out there with.

One or two with larger sales forces.

It's obvious your existing Salesforce is extremely efficient.

But can you maybe just give us an update on the size of your U.S. Salesforce today, and do you see an opportunity to make some additions in 2020.

Yes, I think.

Maybe take a step back can kind of just tell you. The philosophy, we have it's all about efficiency and continuing to see.

The right number in terms of revenue revenue per rep. So I think the way we think about it is.

As long as we continue to see productivity gains as we expand the sales force in multiple ways, we're going to continue to be to doing that.

We certainly want to see.

Marginal contribution for us.

You know that's close to the 2 million dollar range in terms of his views.

On basically saw two around as we add additional ways. So I think we're going to continue to be aggressive.

Just in terms of adding.

Account executives are team, but really thinking about all of the different channels.

In terms of sales and marketing whether its digital marketing whether its.

Co promotions within other organizations I think we're we're evaluating all of those different.

And investing in all those different avenues and aggressively growing them.

Where they can be accretive.

Great in the last one from me your pharma volumes were outstanding Triple digit growth.

Can you talk about maybe your funnel for companion diagnostic side. So we think about 2020.

You know can you give us a sense of the interest to do similar deals like what you have with Astrazeneca for instance.

Yes, so the pipeline looks extremely strong we're seeing a lot of interest in really being able to leverage garden 360 in the fact that it's out there today its units already being used for patient care that give us our partners are running start when they think when thinking about.

Their drugs and being able to get patients tested for those drugs as quickly as possible, we think certainly having a FTC approval.

Behind us is only going to accelerate interest and.

Adoption of the GE Threesixty platform.

For companion diagnostic work, so we were really seeing pipeline that.

It is is very robust and just continues to grow.

Every month.

Great. Thanks, guys.

And your final question comes the line of Puneet Souda with SVB Leerink. Please go ahead.

Yes, Hi help me.

Early congrats on the quarter first of all.

My first question is on on lunar one adjuvant trial that you highlighted here.

When when should we expect to read out and if you can give us some metrics around what the potential for.

You know reduction in times of these adjuvant trials and where the adjuvant.

Reduction in the trial sizes as well.

And as this.

Only one biopharma partnership here just can you if you can give us sort of what's your what's your expectation here in the near term and.

On that point also if you could remind us what's unique about the lunar assay as a tumor naive assay versus the tumor in front of approaches that we're seeing in the market, where it could a tumor naive b most beneficial.

Yes, sure. So actually we are very excited about this clinical validation of zone. There why then.

This prospective study that very bad who is.

Our partners is stage on various on healthier.

A lot more information about the.

Study.

Although we shake without fills in more details our other partners involved that.

Oh, you more right now, but it's stage that based on there.

Interesting announcement on Airwatch in terms of why we think our product is better.

In our new owner assays in general we are looking at somebody Fantasia sham various altogether.

As for another one of your specific recast some added and his time excavation signatures and lot.

No fire information about the tumor, but just the fact that yes, I think somatic mutation.

In addition gives you a lot of opportunities in terms of having to.

Much better test in terms of performance and Val if you add the logistical challenges.

Looking at all.

There are sizing and as a based on what you find out that human rights issue I think.

I would imagine which area a lot of.

Logistical challenges.

Our perspective.

Very excited about what the or anything that performances that.

We've seen so far while here mixing.

Right.

Seatbelts together.

Okay. Thanks for that and if I could ask on the clinical growth, obviously very strong growth here.

Can you elaborate on the mix of test that you are.

Getting from newer oncologist or more for community setting versus.

New centers or versus your more since prior centers that you have had and in terms of the.

Expectations off newer centers AD and the Salesforce, where where you stand currently can you continue to drive that would would the existing sales and commercial force you have.

Yes, I think as we commented earlier was certainly seeing.

Tremendous growth in the community setting we are now about 60% community in terms of our volume.

We also have seen I think of fairly good growth in terms of Sam same physician sales.

So we're seeing repeat.

Use of garden Threesixty grow, but we're also continuing despite does being four or five years.

Post commercialization on many thousands of oncologists that a border the test we're still adding.

New oncologist per month really at a record pace and so we're seeing I think robust signals of growth across really those those three.

Metrics, which are the signs you want to see in terms of continued penetration into the clinical market at least clinical oncology market.

Okay, and then if I could ask on omni what's been the feedback from biopharm overall, our they really utilizing the broad menu of genes here 500, or so and the features a if you could talk about.

Are you seeing demand for those features and specifically.

Before.

M.B. and my question, mainly on TMB is.

There seems to be more.

You know sort of questions and a rounded rather than conclusions.

Among the bio pharma data that we have seen so far you have a unique vantage point, what's your view on TMB oral thank you.

Yes, I think there's certainly been an ebb and flow around tumor mutational burden, we see TMB is one step along a continuum and a paradigm shift to using a lot more genomic information to segment patients than using single Biomarkers.

Or using.

Single proteins and so on to do that so you know regardless of where TMB I think shakes out.

You know that approach is something that is certainly.

The the precision medicine informed approach or genomic and form AFFO to certainly where the puck is heading and so I think as we mentioned in our prepared remarks.

You need pretty complex genomic information for things like modest repair deficiencies for PARP inhibitors were seeing you know a lot of markers of interest that.

Our outside of what garden Threesixty happens to offer now, becoming and vogan and really seeing the pendulum I think swing back from immuno oncology to targeted therapy development as well, which is a nice weeds, but really seeing both sides of the.

The.

Kind of the drug development.

Picture really kind of move aggressively forward, we're seeing a lot more competition in this space and so a lot of our Biopharma partners really want to understand as much as they can about there.

They are drugs in their their assets so that they can be as competitive as possible and that's really where garden omni I think fits in terms of being able to provide that information.

That can be useful.

Alright, great. Thanks, congrats on the quarter.

Thanks.

And I'm showing no further questions at this time I would now like to turn the conference back to Miami OLTP for closing remarks.

Well, thank you again and I look forward to.

Toggling again that our next earnings call. Thank you.

Ladies and gentlemen. This concludes today's conference. Thank you very your participation and have a wonderful day you may all disconnect.

Q3 2019 Earnings Call

Demo

Guardant Health

Earnings

Q3 2019 Earnings Call

GH

Thursday, November 7th, 2019 at 9:30 PM

Transcript

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