Ladies and gentlemen, thank you for standing by, and welcome to the Guardant Health Q4 2020 Earnings Conference Call. At this time, all participants' lines are in a listen only mode. After the speakers' presentation, there will be a question and answer Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Ms. Carrie Mendiville.
Thank you. Please go ahead, ma'am.
Thank you. Earlier today, Guardant Health released financial results for the quarter full year ended December 31, 2020. If you've not received this news release or if you'd like to be added to the company's distribution list, please send an email to investorsgardenhealth .com. Joining me today from Guardant Health is Helmy Elsoukie, Chief Executive Officer Amir Elieb Halazaz, President and Mike Balfe, Chief Financial Officer. Before I begin, I'd like to remind you that management will make statements during this call that are forward looking statements within the meaning of federal securities laws.
These statements involve material risks and uncertainties that could cause actual results or events to materially differ from those anticipated. Additional information regarding these risks and uncertainties appears in the section entitled Forward Looking Statements in the press release Guardant issued today. For a more complete list and description, please see the Risk Factors section on the company's annual report on Form 10 ks for the year ended December 31, 2020, and in its other filings with the Securities and Exchange Commission. This call will also include a discussion of certain financial measures that are not calculated in accordance with generally accepted accounting principles. Reconciliation to the most directly comparable GAAP financial measure may be found in Earnings Release submitted to the SEC.
Except as required by law, Guardant disclaims any intention or obligation to update or revise any financial projections or forward looking statements, whether because of new information, future events or otherwise. This conference call contains time sensitive information and
Thanks, Carrie. Good afternoon and thank you for joining our Q4 and full year 2020 earnings call. We founded Guardant with a mission to improve outcomes for patients across the continuum of cancer care. The cornerstone of everything we do at Guardant is motivated by this commitment to serve patients. I'm particularly encouraged by the resilience and perseverance of our team to maintaining this commitment despite the strain that the pandemic has presented to the care delivery systems in the U.
S. And abroad. And so consistent with these values, I will start off our call with a patient story. Shortly after giving birth, A 43 year old woman was diagnosed with metastatic cancer. By the time of her diagnosis, her cancer had progressed so aggressively That she was not a candidate for chemotherapy.
She was extremely weak, only able to drink a bit of water throughout the day. The hospital immediately brought in palliative care and began making plans to bring her to a hospice. At the same time, her oncologist ordered a Guardant360 And received the results within a matter of days. Results showed a RET mutation and our oncologist was able to confirm with a PETCT scan that she had non small cell lung cancer. He immediately made the decision to put her on Gabretto, a targeted therapy for patients with RET positive metastatic non small cell lung cancer.
It arrived the next morning and the patient was able to begin treatment 18 hours after getting her Guardant360 test results. Within 4 days, she was already showing encouraging progress. She is much more alert and awake, eating throughout the day and able to hold her newborn daughter. Her story demonstrates how critical time can be when treating patients with aggressive late stage cancers and how our liquid biopsy platform can rapidly produce results to enable oncologists to make quick treatment decisions and match them with cutting edge therapies. There is no doubt that 2020 was an extraordinarily challenging year.
I could not be more proud of the Guardant team for their steadfast commitment to serving cancer patients in our core business as well as our recent efforts to alleviate We ended the year with $287,000,000 in revenue, growing 34% over 2019. In therapy selection, clinical volumes for Guardant360 grew 27% to 63,254 tests. Clinical growth was strong despite a virtual selling environment and widespread office closures, which Recent data has shown results within a 65% decline in new patient diagnosis this year. We continue to make progress on the reimbursement front And now have more than 200,000,000 covered lives for non small cell lung cancer and more than 100,000,000 covered lives for multi cancer testing. This progress in reimbursement led to 70% growth in our clinical revenues compared to the prior year.
We received FDA approval for Guardant360 CDX And as a companion diagnostic to identify non small cell lung cancer patients with EGFR alterations who may benefit from treatment with Calgarissa. Following this approval, we launched 2 versions of our Guardant360 test, Guardant360 CDx, the FDA approved version of our assay and Guardant360 LDT, the next generation version of the assay that offers additional biomarkers. We also announced 3 new CDX partnerships with Janssen, Amgen and Radius Health. In recurrence monitoring, we initiated multiple studies which are aiming to establish clinical utility for the detection of ctDNA in the adjuvant setting in colon cancer. And in early detection, we continue to make progress enrolling patients in our Clip study onboarding more than 150 enrollment sites, exceeding our target and are on track to complete enrollment in 2021.
Looking at the Q4, we ended with $78,300,000 of revenue, growing 25% over the Q4 of 2019. Clinical volumes for Guardant360 grew to 17,353 tests, a 14% increase compared to the Q4 of 2019. After the successful launch of Guardant360 CDX in September, we were encouraged by the acceleration of volume and addition of new customers that we saw in October. Unfortunately, the COVID resurgence adversely affected access to oncology accounts with office closures approaching Early pandemic levels towards the middle of November and for all of December. Despite these extraordinary challenges, We are encouraged by the growth of not only Guardant360 test orders, but by the continued growth in the total number of oncologists ordering our tests per quarter, Another record number in Q4.
We are confident that outside of the impacts related to COVID, The fundamental drivers of adoption for liquid biopsy remain intact. This belief is certainly bolstered by the strong recovery we are seeing at and are investing in programs to expand global access to our liquid biopsy program. We have partnered with 1 of the premier cancer centers in Spain, Galder Braun Institute of Oncology to help build a liquid biopsy lab that will physically bring our technology to Europe. We have also achieved critical regulatory accreditations, including CE marking for Guardant360 CDX and important ISO certifications. In APAC, through our joint venture, we are also making excellent progress and expanding our commercial reach with testing now being provided in over 40 countries.
I'm excited to announce that we recently submitted our And our new lab is expected to be operational in Japan later this year. Looking ahead in 2021, we expect revenues to continue to increase over 2020 with accelerated growth in the second half of the year. I believe this will be a pivotal year for Guardant as we continue to invest across our business to build the foundations for complete cancer testing across the continuum of care. In our therapy selection business, we expect to continue to expand the utility of Guardant360 with additional approvals, clinical data, as well as broadening use of the test in the molecular response and monitoring settings. These developments will serve to grow the total addressable market from $6,000,000,000 today as these new applications of liquid biopsy take hold.
We are also very excited for the upcoming launch of our first tissue product, which we believe will address the unmet need that persists in the therapy selection market due to the challenges with many of the existing tissue In recurrence monitoring, we are breaking new ground just as we did with Guardant360 several years ago, Ushering in a new era of precision oncology for earlier stage patients through the launch of Guardant Reveal last week. This launch marks our formal commercial entry into the estimated $15,000,000,000 opportunity of residual disease detection and recurrence monitoring that we believe will only grow as clinical and at pharma applications of this technology increasingly become a new standard of care. In screening, we expect to complete enrollment of our clips colorectal cancer screening trial and expand into other cancer types, addressing an estimated $50,000,000,000 cleaning opportunity. We also significantly strengthened our balance sheet with 2 capital raises during the year, ending 2020 with $2,000,000,000 in cash. With this capital, We are well positioned to aggressively invest in 2021 and beyond, which will more firmly secure and open up A massive opportunity to transform cancer care for millions of patients.
With that, I will now turn the call over to AmirAli for more detail on our biopharma business and our pipeline activities.
Thanks, Helmy. Starting with our biopharma business, Sample volume in Q4 of 2020 was 4,841 tests, 23% below the prior year period. However, volumes were up 50 8% from the Q3 of 2020, reflecting partial recovery from COVID, but more so The year end rush for sample analysis. Developmental services and other revenue grew 100 and 48% to $13,600,000 reflecting our growing pipeline of CVX partnerships and prospective studies. We are pleased with our progress in pharma testing volumes and growing CDx partnerships.
However, in the first half of the year, we expect the impact of COVID to continue to be felt with slower trial enrollment, We are pleased to announce that we have submitted supplemental PMAs for our collaboration with Janssen, With Amivantanet and with Amgen for suterosib, the selection of Guardant360 CDx As the frontline liquid biopsy device of choice in these two programs demonstrates the growing confidence of biopharma in our IBD offering. FDA granted priority review or breakthrough therapy designation for these therapies, and we expect We believe liquid biopsy tests can add additional clinical benefit to cancer patients Beyond just treatment selection, we have over 4 d publications that demonstrate that a second liquid biopsy She tests a few weeks after treatment initiation can segment responders versus non responders across multiple tumor types and multiple classes of therapies. These are exciting days for liquid biopsy, and it's clear that As more of these tools become part of clinical practice, such usage will usher in even more applications, Many that we cannot even imagine today. Now turning to our LUNAR program. As Helmy mentioned, last week, we were excited to announce the launch of Guardant ReVeil, the first blood only liquid biopsy test For the detection of residual and recurrent disease, with a simple blood draw, this test improves the management of Early stage colorectal cancer patients by detecting ctDNA in blood after surgery to identify patients with residual disease Guardant's reveal is in a class of its own with industry leading sensitivity and specificity And also have turnaround times of 4 to 8 weeks.
EA, which is the current standard of care, has a sensitivity of This level of performance has been achieved Through analysis of over 400 kilobytes of genome spanning across thousands of regions 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 or de escalation of treatment. The platform technology we use for our MRD test is based on the integrated analysis of somatic We'll continue to have market leading performance as we expand Guardant's Rebuild to multi cancer types in the near future. Turning to Eclipse, we continue to see robust patient enrollments throughout the Q4. We have now over 150 sites Actively enrolling patients.
Overall, we are pleased with our progress
and are
on track to complete enrollment in 2021. If successful, Eclipse will play a pivotal role in regulatory approval and reimbursement of our liquid biopsy screening We are starting to plan our next screening clinical trial in other cancer types and expect to share more updates about this in the latter part of 2021. With that, I will turn the call over to Mike for for more detail of our financials. Mike?
Thanks, AmirAli. Total revenue for the Q4 of 20 20 was $78,300,000 up 25 percent from $62,900,000 in the prior year quarter. This growth was driven by a year over year increase in both precision oncology testing revenue and development services and other revenue. Total precision oncology testing ready for the Q4 was $64,700,000 a growth of 13% compared to $57,400,000 in the prior year quarter. Precision Oncology revenue from clinical tests in the 4th quarter was $45,900,000 up 47% from $31,300,000 for the prior year quarter.
4th quarter clinical test volume was $17,353, up 14% from the prior year quarter. The chemical test beverage selling price was 2,642 in the Q4 of 2020, up from 2,049 in the prior year period. The 29% increase in the clinical test ASP over the prior year quarter was principally due to expanded medical coverage of non lung cancer tests, which commenced in March 2020 and our success in gaining private payer coverage of our tests. Although clinical test volume increased sequentially by 2% in the Q4 compared to the Q3 of 2020, Clinical cash revenue of $45,900,000 decreased by $2,400,000 compared to $48,300,000 in the Q3 of 2020. This was primarily due to quarter over quarter fluctuations in the revenue recognized from cash collected The test performed in the prior periods, reaching the Q4 of 2020, was $3,000,000 lower than in the Q3 of 2020.
Precision oncology revenue from biopharma testing in the 4th quarter totaled 18,800,000 down 28% from $26,200,000 for the prior year quarter, but sequentially up 57% from $12,000,000 in the Q3 of 2020. 4th quarter biopharma test totaled $4,841 down 23% in the prior year quarter. However, sequential test volume was up 58% In the Q3 of 2020, due to a partial recovery from COVID and the usual year end seasonality. Biopharma test ASP was 3,000 Development services and other revenue in the 4th quarter totaled $13,600,000 of 148% from the prior year quarter. Gross profit for the Q4 of 2020 was $49,900,000 compared to a gross profit of $41,100,000 in the same period of the prior year.
Gross margin in the 4th quarter was 64% compared to 65% during the Q4 of 2019. We expect our gross margins to continue to be in the mid-60s range For the foreseeable future as we launch new products such as Guardant Reveal, which will take time to gain new investment coverage from Medicare and from private payers. Total operating expenses for the Q4 of 2020 were $141,100,000 a 110% increase from €67,000,000 in the Q4 of 2019. This change was driven by an increase of €51,300,000 Stock based compensation expense primarily related to market based restricted state units, granted 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, we expect stock based compensation expense to be between $170,000,000 $180,000,000 for the full year.
In addition, We expect operating expenses to accelerate in 2021 as we continue to invest in our LUNAR program, Eclipse study and other development activities as well as launch new products and expand our commercial organization in both the U. S. And internationally. Net loss attributable to Cardenal's common stockholders was $93,700,000 or $0.94 per share for the Q4 of 2020 compared to $25,200,000 or $0.27 per share in the Q4 of 2019. Adjusted EBITDA was a loss of $29,800,000 in the Q4 of 2020 compared to a $17,100,000 loss in the Q4 of 2019.
As a reminder, we define adjusted EBITDA as net loss attributable to Guardant Health adjusted for stock based compensation, interest, Income tax, depreciation, amortization, other income and expense, non controlling interest, contingent consideration and acquisition related expenses. Turning now to the full year 2020. Total revenue was $286,700,000 a 34% increase $136,300,000 and is comprised of clinical testing revenue of $171,800,000 which grew 70% year over year and biopharma testing revenue of $64,500,000 which declined 19% year over year. Despite the adverse impacts of COVID, clinical test volumes for the year grew to 62,254, up 27% year over year from 49,926 tests. The average revenue recognized for clinical test in 2020 rose 34% from the prior year, Primarily as a result of the expanded Medicare coverage of non lung cancer tests which commenced in March 2020 and our success in daily private pay coverage of our tests.
Clinical revenue for the year early to CENTRE31, 2020 also included $11,900,000 revenue for payments from MediCath from peers for sample prices in prior years compared to $6,800,000 revenue in 2019. The The company does not expect to continue to exceed payments or record revenue for these specific appeals in 2021. Biopharma testing volume was also impacted by COVID in 2020. And despite a partial recovery in the 4th quarter, declined 23% year over year to 15,983 tests. Development services and other revenue grew 49% to $50,400,000 in 2020, reflecting our growing pipeline of CDx partnerships and prospective studies.
Net loss attributable to Guardant Health common stockholders was $2,800,000 compared to 75,700,000 In 2019, net loss per share was $2.60 in 2020 as compared to $0.84 in 2019. Adjusted EBITDA was a loss of $85,200,000 in 2020 compared to a loss of $53,300,000 in 2019. We ended 2020 with $2,000,000,000 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, We view the fundamental drivers of our business to be very strong and as such expect 2021 revenue to be between $70,000,000 representing growth of approximately 27% over 2020 at the midpoint of the range.
We expect clinical sample volume for 2021 to be greater than 90,000 tests, which represents growth of at least 42% over 2020. Embedded in our outlook are a few key assumptions around reimbursement. Firstly, we anticipate that the The billing code change to Guardant360 CDX in April to an ADL2 PLA code may have a short term impact on private payroll reimbursement, This could offset any positive impact we will see from an increased ADLT reimbursement rate from Medistar. Secondly, Although we are excited about the launch of new tests such as Guardant review, it will take time to receive Medicare coverage and subsequent private pay coverage. And as such, we do not expect the As Helmy and Amaroli both mentioned, We are still experiencing COVID related impacts across our clinical and biopharma businesses, and we anticipate that these impacts will continue in the first half of the year.
Specifically, in the Q1 of 2021, we expect to see a reduction in biopharma volume compared to the seasonally high Q4 of 2020. Furthermore, as I mentioned earlier, we do not expect to record revenue in 2021 from Medicare peers for samples processed in prior years, which in the Q4 of 2020 touches $4,600,000 As a result of these factors, we expect revenue in the Q1 of 2021 to sequentially lower than in the Q4 of 2020. However, as we move beyond some of the COVID headwinds and coding transitions in the first half of twenty twenty one, we
Thanks, Mike. Before closing, I want to again thank our team at Guardant for the dedication and effort they have shown, Particularly over the past few quarters, I believe that 2021 will be an unprecedented year for Guardant as we are bringing to fruition the vision we 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 breadth of our product portfolio. I'm confident that these product launches will serve as drivers for strong growth in 2022 and beyond. These new products also mark an important inflection point as we begin to transform Guardant from the leading liquid biopsy company to the leading cancer testing company.
With that, we'll now open it up to questions.
Your first question comes from the line of Brian Weinstein with William
Blair. Hey, guys. Thanks for taking the questions. Lot A lot to get into here, but we've heard a lot of companies this earnings season talk about significant investments Going into 2021 given all of the new products that are out there. I'm curious if you can talk about The specific investments that you are 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 going and give us some idea around those, specifically around things like preparing for the CRC launch, which is still a little bit of ways, but something that you have to start to be thinking about or Commercial efforts for the MRD assay as you think about scaling that up or anywhere else. I'm just curious where you think the key areas are for investment this year?
Hey, Brian, it's Satya again. Yes, we're making investments across our organization. I'll start and then let's maybe Mike fill in. But certainly, it's focused on our pipeline activities in R and D, I'm just investing certainly
in these
new products, the new trials that we have And if some R and D for new programs we have, kind of certainly Scaling up the commercial side of the organization, obviously these new products, Santenacil themselves, we're expanding into other parts of oncology And also starting to think about as we race down the finish line of the clips, really the commercial planning stages for Yes.
Maybe just to add, Brian, for us it's a A pivotal year of investment as you mentioned. And when we look at the operating expense, yes, we think that's going To ramp up as we make these investments, something like an increase of €150,000,000 to €180,000,000 Increased over the year compared to 2020. So yes, that's what we're looking at for this year coming.
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 G360 already in the market clinically is something that provides you any kind of clinical advantage when talking to clinicians. Thanks.
Yes, sure. So what we are actually just a couple of weeks into this commercial activity around So far I can tell you it's super good. Very excited with the enthusiasm that we are seeing. Really many of our KOLs and technology enthusiasts, they can early adopters that we are targeting at this stage are Overlapping with the type of people we interacted with for Guardant360, they have kind of pretty good respect for the quality of the Product and services that they've got from Guardant Health throughout the years. They are amazed and actually very happy with the fact that we are It's not only test that does not really depend on having access to tumor tissue and also with Market leading performance, while logistically is much better, turnaround time is much better.
It doesn't come out Sacrifice of the clinical sensitivity and specificity for their patients. Really the way they are comparing us with is with CA, a standard of That's my true to the conversation that we are having with the doctors at this time and the delta between REVEAL and CEA is very obvious, performance of 6,469 versus 9,100 is, I think, a
Your next question comes from the line of Tycho Peterson from JPMorgan.
Hey, thanks. Similar line of question on the tissue launch. Just curious, A, what you think the market was really missing between foundation Sure. And then also the FDA approval pathway.
Yes. Thanks, Doug, for the question. It's something we obviously have I thought about it for some time. It was really a matter of when, not if. And when we look at the tissue space, We were still quite surprised that how much of a challenge ordering these tissue tests It continues to be.
If you think about it, the end to end time from a physician point of view is 3 to 4 weeks. I know a lot of them today, they're 10 days, 14 days, but in terms of the tissue acquisition, actually getting the results back, it really takes 3 to 4 weeks, which is a nonstarter in terms of The time to treatment decision and urgency the oncologist has in the frontline setting. And so we realized that if we The range is on hand with CGC and really catalyzing the market that we've developed our own tissue test. We could really integrate that with our current offerings and provide a user experience customer experience that is completely differentiated in terms of Getting more markers faster and quicker and more completely. And that's really the experience that We expect to be able to provide the division.
So the way we think about it is that in the base case, we'll be able to And I think in the bull case, we'll certainly be able to take a Considerable share from some of the existing players. But some of the challenges I think that exist are that there's still a large percentage of patients, We're 50 percent of patients that aren't unit tests comprehensively and even more of that aren't unit tests in the frontline setting Before the trigger is pulled for treatment and that's the challenge and that's the unmet need we think we can squarely address for this tissue offering.
Okay. That's helpful. And then on G360, just curious how we should think about the mix between G360 and the LDP?
Yes. I think you can imagine that both 360 CDX and 360 LDT is going to have their own life cycle management. CDX most probably is going to get updated as an IBD grade device and with less frequency than Guardant 360 LBT as a Nokia grade device. I think that would be seen in our portfolio would really enable us to be nimble and add newly upcoming biomarkers On the clinical practice or on the pharma trial practice actually passed their entire offerings and CDx We go through the revisions with lower frequency, as I mentioned. But both of them are going to get upgraded
Okay. Last one, just curious, as we
think about the ECLIPSE study
kind of getting wrapped up later this year, Any comments you guys can make on follow on studies for lung, breast, some other indications?
Yes, sure. Actually, we are pretty excited about this topic. And I think Starting 2 years ago when we talked about our admissions around early cancer screening, even before that, we talked about 4 cancer types that at the time were pursuing CRC was one of them, the other one was lung cancer, breast cancer and ovarian cancer. We've actually, I think, some pilot data for SOPHIE cancer types earlier, and we made some progress for SOPHIE cancer types. So We believe the platform technology that we have that integrates the genomic biomarkers with epigenomics.
And on the epigenomic side, Mentulation plus all the structural changes as a result of fragmentation pattern changes is super duper powerful to find Cancers in early stages of disease and we are happy with some of the visibility data that we've seen in other cancer type that I think it's really the prime time that after we really get eclipsed with hopefully the last innings of it, We start talking and doing some clinical trials around other cancer types. The future of our run up program would be The multi cancer screening program lets CIC continue to be our leading indication in this marketplace.
Okay, that's helpful. Thank you.
Your next question comes from the line of Doug Schenkel from Cowen.
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 Guardant Reveal. So first, the high level question.
I think it's fair to say that
you guys 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 AACR. This put you in a position to not just launch G360, 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 Ed, the market is getting more crowded as menus from competitors seem to be evolving in a way where It looks like there's going to be 4 to 5 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 4 to 5 years, if not sooner. That's long been our view, but it I think the pace of moving towards that is accelerating.
I mean, even you guys has come up a couple of times on this call, launched a tissue product, And the MRD 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 and 4 or 5 other companies Have a menu that goes from multi cancer and single cancer screening to therapy selection in blood and Issue to monitoring, what's going to differentiate Guardant from others in the long term?
That's a great question, Doug, One that obviously we spent a lot of time on thinking as a company. It's not just one dimension that differentiates us. Even EmTherapy selection when we launched, There are probably a couple dozen companies in the lithography space. And so on the surface, you could say that There's always been competition and there's always been a crowded field. But in reality, it's really the quality, The level of performance of these products, the level of clinical evidence that supports them, really the customer Service channel, the white glove service that we provide, billing and reimbursement, it really takes 5 or 6 different dimensions to
Really a
change in standard of care, a change in clinical practice in health care, as you all know. And we believe that we are second to none. And Each one of those, as I mentioned, not just in therapy selection, but really taking that same approach to these new products that we are launching as well. And so, Yes. We're actually, I think pleasantly surprised by how much differentiation still continues to exist with 360 versus Every other product that hasn't been launched that's out there.
And it's no different with the reveal. On the surface, you There's a bunch of companies working on MRT, but, you know, Reveal now is really the only, what we believe, truly good biopsy In the market that's issue independent that really has advantages of liquid without any disadvantages in terms of performance and Customer service and customer experience. And so if you think about it, we're the one company that really does And that entire maintaining of care that is very strong channel in oncology market, over 9,000 oncologists have ordered that test and That's probably a broad reimbursement for products like Guardant360. And so we're, I think, pretty pleased with how the market Last thing I will say is that competition is important because it defines markets, it brings awareness to new products and I think it really allows physicians to understand and clients and customers to understand Really the use cases and what good looks like. It's hard to really have differentiation in terms of the
Thanks for all that. That's helpful and interesting. And now for the REVEAL specific question. In your recent presentations and press release, I think you indicated that Reveal has a sensitivity of 91%. You talked about that in your Fair remarks today as well.
I believe this improvement is at least in part Attributable to the fact that on top of methylation markers, you've now added genomic alteration assessment to the assay. I may be oversimplifying or maybe misstating this, but assuming I'm going down the right path, I'm just wondering if the addition of these additional markers, which seemed to be important to improving performance Have 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 to accommodate the additional markers on this asset. And then probably a more simple question, and I know it's early, but I Believe that most would assert that there is an inherent advantage to using a non bespoke test versus a tumor informed 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.
Thanks, Doug.
Regarding this core platform technology for REVEAL, Maybe starting with that 91% sensitivity
that I mentioned in
the script, actually that's the sensitivity in the surveillance When you're trying to detect early relapse, which is the Vadricka actually the opportunity in CRC setting. Now This is the exact same assay that we are using in our clinical trials for cobra and standard to cancer in fact, Except some process improvement happened for scalability of this device for So some of the process and operational infrastructure has improved for device, but the assay and impact the performance is very, very similar to what we are doing our But yes, the core platform is based on Combining and integrating multimodal information from the same cell free DNA fragment, which in this case we are Combining somatic, intangential and methylation for MRD setting. Reactions of KOLs and the target list that we had, still it's as I mentioned, it's early during the 2nd week of this commercial launch, but All the conversations so far has been very, very positive. And I think this is really resonating with Customers that we talked to so far that a blood only assay can really help their practice tremendously. And really they are comparing the performances with other blood only standard of care assay like CA.
And they are saying that the performance and the promise is a big delta in terms of performance on promise here and that generates a lot of excitement. Having said that, We think it's going to take some time for adoption of this test. Multiple conversation needs to happen in order for this thing to get This does get adopted, but we are super pleased with the early reaction of the market to what we put out there.
Thank you for that. And just one thing I may have missed in that answer in terms of the sample size requirement, nothing different with the current version Recognizing that it's pretty consistent with what you're doing as part of that other study?
Yes, it's the same actually the number of blood tubes, if you mean, in terms of sample It's the same number of blood tubes that we are getting for our clinical trials. It's exactly the same. It's more we made it more scalable
Okay. All right. Thank you very much.
Your next question comes from the line of Puneet Souda from SVB Leerink.
All right, great. Thanks Helmy and Amerile. First question I have is on guidance. You're Projecting 90,000 in terms of test volumes here, which feels pretty robust. But the revenue growth for the full year is coming in slightly lower than what we had anticipated.
And so I just want to hear and you're pointing out biopharma volume reduction in the 1st quarter And Medicare appeals also not being included. So 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 for biopharma services, Omni G360 currently and what is the demand outlook from biopharma throughout the year? Because As I view it, not only you'll 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 want to get a sense on how should we view the biopharma growth?
I mean, we think that's going
to be strong. We think it will be low double digit growth. So carrying on that sort of a robust performance. I think you mentioned that a bit of a difference even though we talk about strong clinical volume, maybe a bit of a difference From the numbers that you added, I think the main driver there is on the clinical ASP. We saw the ASP being around 2,600 in the 4th quarter and that's probably likely to be the ASP Throughout 2021, I laid out some assumptions on reimbursements around new products and not expecting reimbursement for those and nonmaterial revenue for those.
And also potentially the issues with private payers as we switch CDX To an ADLT PLA code. So I think, really the discrepancy is not coming from biopharma volume, which again, we think is strong. It's more on the ASP assumptions that are on them.
Okay. That's very helpful. And then on the ECLIPSE study, Helmy, it It appears the enrollment is progressing well. Wondering if we should expect anything, any other data That were smaller cohorts and whatnot and maybe AACR, you have DDW coming up as well and ASCO, could you maybe just elaborate potential for any datasets, smaller datasets there? And again, if you could just maybe clarify on the timing of the readout here for Eclipse because I think that's highly anticipated Among investors.
Yes, sure. So in terms of the upcoming Thank you, David. If you could imagine like many major conferences, we are going to continue to provide some additional data. In fact, our collaborators are going to contribute a lot of data. We gave access to our device to a bunch of Collaborators to assess the performance of our screening assay in different cohorts.
Having said that, All those cohorts is kind of in a biobank setting, and there are similarities It's been the type of data we showed before versus what it's going to get presented. But I think so far, all the data are positive and more to come in different Congress is in terms of the data set similar to what we expect from Eclipse, which is prospective screening of 10,000 Patients, we are not going to have such data, we'll be really get it from Eclipse. We need to be still patient for that study to finish.
Okay. And then lastly. Yes, go ahead.
If you could just take a part of your question.
Yes, I mean, it was just in terms of the timeline for Eclipse and given the growth the robust
Yes. So, so far, actually, we are expecting that the study would finish by the And the timelines that we always mentioned. So, so far so good. We'll see how it continues during the remainder of the next few months.
Okay, great. And last one, if I could squeeze in on MRD and recurrence monitoring. Obviously, You have had data here in CRC, but when we look at another competitor in space, there is there So I think more publications, more data sets that have come out. Obviously, Guardant is focused on building strong clinical evidence for Products and is usually the first one to do so. So maybe just if you could elaborate for us the efforts that you are Doing on recurrence monitoring, the CRC and maybe indications beyond that in eye or lung or breast that could potentially yield Further data sets and clinical evidence that helps physicians look at the assay more closely.
Thank you. Absolutely. So there are several ISDs that actually are finished. There are several other ones which are ongoing. We have a 9 inch script that the data that we are talking about in terms of performance of our reveal is I'm in front of collaboration with our major partners, major cancer centers in the United States.
So there is a manuscript under review that
of Tejas Svante from Morgan Stanley.
Hey, guys. Good evening. Thanks for the time here. Helmy and AmirAli, on the tissue biopsy launch, Helmy, you've spoken a couple of times about sort of The importance of reducing the turnaround time there versus 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 times since Pathologists who take some time to draw the sample and send it off to the lab. And how exactly do you plan to sort of compress that time line relative to some of the other competition out there?
That's Great question. I mean, I think I would just refer you to our liquid biopsy. We're averaging about 5 days on average in terms of turnaround time and you look at a lot of other liquid biopsies out there, they're 10, 14 days, sometimes even longer. And that's not even taking into account pathology time and getting tissue access. So there's certainly, I think a level of automation and operational excellence that we have in our organization that Doesn't seem to be matched with other products that are out there.
And so clearly, there's a lot of know how that we can Confirm and apply to the tissue side of the process. So I'm very confident that it's not just about And the tissue product on its own. It's also about how all these products work together, lipid products, the tissue products. And I think in having that sort of integrated offering, we can provide a customer experience, which is More aligned with what Ancology is trying to see, which is making sure they get everything they can in terms of biomarkers And their patients as quickly as possible and not missing anything. And we think we'll be able to provide that experience that It's at a level that really hasn't been seen in this field to date.
Got it. That's helpful. And one quick follow-up for Mike. Just in terms of the guide here, how are you what are you sort of Including for OUS expansion, I mean, obviously, you've got the wildebran partnership you announced and the Japan expansion as well. So OUS and then on the Development Services front, I mean, obviously, sort of an uptick in 2020 there.
How much of a normalization should we expect and that line item in 2021?
Well, on the OUS, of
course, we're not breaking out those numbers. But we think that's a great opportunity for us and probably an opportunity for upside throughout the year as to As to how that goes in both Europe and in Asia. On the development services side, Yes, I mean we've seen that strong over the last three quarters actually. And so I think that will continue through the year And then we're bullish about the development services revenue throughout 2021.
All right. Thanks so much, guys.
Your next question comes from the line of Derik to 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 sort of get the readout, the potential for commercialization, Just your general thoughts on LDT versus inclusion in guidelines. This is an area we're skipping a lot of input on Investors just basically wanting to understand what your approach is and do you need to go out and build a sales force and is that written built into your plan. Just a little bit more on your commercialization efforts on ECLIPSE would be really helpful. And that's my only question.
Thanks.
Sorry, there was a little discussion. I think we started in November of 2019, I think, about 24 months. And so, yeah, that's what the timeline for enrollment will be. It'll take, you know, another little bit of time to process the samples and The data is collated and then get that submitted to the FDA. In the meantime, clearly, we're very optimistic about The performance we've released in the data already in other cohorts where we have in what we believe is performance that We'll meet the standards and the minimum thresholds that have been outlined in the NCD for Medicare coverage.
So I think we're cautiously optimistic that Hillcrest
will be able
to read out, well above those targets. And so in the meantime, we are laying out the foundations for commercial And so that's going to take considerable investment. And we are certainly in the early stages of laying that out and building out the team so that as soon as The data reads out, we're ready to go.
Your next question comes from the line of Patrick Donnelly with Citi.
Great. Thanks guys. Helmy, maybe one for you just on the guidance. Certainly Appreciate that your guys' volumes weren't pressured nearly as much as other diagnostic tests during COVID, so the recovery, they're not going to be quite as sharp. Can you just talk through, I guess, the impact you saw as we went through 4Q?
And then
the level of conservatism that's kind
of baked in here as we think about The trajectory as we go through 2021 in terms of patients coming back, again, obviously, the impact wasn't quite as significant given your patient set. Just curious in terms
of how you factor that in volume then?
Yes. No, I can start and then Mike So yes, Q4 was interesting. Obviously, we are just coming off the heels of our launch of our CDX And our LVP. And we really saw a nice acceleration in terms of the number of physicians during the test, the Volume that we're seeing in terms of both of those tests, so it's very encouraging. But as you know, I think the resurgence of COVID was Probably greater than most had really anticipated at that time or before that time and Really caused significant impact in terms of office closures.
I think we went well below 20% in terms of In person, you know, business, really similar to the height of the pandemic in April May in terms of access. And so it's a very challenging environment to be able to sell there. But I think despite that, you saw very nice, I think year over year growth in Q4. And so I think it's a testament to both the, I I think differentiation of the products as well as really the resilience of the Guardant team as well as resilience of these physician offices that I've learned to, I think, deal with patient care in this new environment. I think baked into the numbers we have for 2021, I think we had considerable growth there in terms of the clinical volume of 90,000 Over 2020.
And so I think we are very bullish in terms of in the first half of the year. And we expect, as we're seeing COVID It has declined and hopefully they continue to do so over the next couple of quarters that we're able to see Further acceleration in growth in the back half of the year.
Yes, maybe Helmut Just to add,
but I think you said it all, but really relating to our assumption is COVID And of course, everything is factoring dependent on how that can roll out, but we built into the numbers really a COVID In the first half of the year and then making an assumption that in the second half of the year that sort of alleviated. So that's how we're looking at the year and that's relating to our numbers. But as Henry said, we still think if we achieve 90,000 clinical tests in
Your next question comes from the line of Dan Arias from Stifel.
Yes. Hi, guys. Thanks for getting me in here. Helmy, maybe just one for 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 in another?
In other words, If you build on the ESMO data and if COBRA reads out positively, can that sort of be a gateway to adoption in other cancers? Or do you think that, you know, you kind of have to prove things out tumor type by tumor type?
Yeah. I think what we can take parallels from what we did with 360 in terms of really, almost singularly focusing on lung initially. And what we found was that And by using Compass that leads us in the direction of maximum clinical utility that really maximizes the And it's a positive reaction of the user experience. So as these products find utility Impact decision making in one cancer type. Given that many physicians are generalists and they're seeing many other cancer types, We found that that kind of translates into positive perceptions and I think we're seeing clinical utility in other cancer types as well.
And so ever since we've had strong traction in lung cancer, We've seen growth in other cancer sites that are continuing to track the growth that we've had in the month. That being said, as we prove out specific cases for gene utility and other cancer tests, Those can be added drivers for those specific indications. We've seen that With 360, when we have drug approvals in breast cancer or in prostate and so on, and We've seen considerable step function increases in volume for the specific indications. And so we believe that it will be no different for
Your next question comes from the line of Matt Mazzucci from Canaccord Genuity. Hey, thanks for squeezing me in.
In the prepared remarks, you spoke about the 65% decline of new diagnoses of Cancer in 2020, unfortunately, some of these patients may never have the chance to receive a Guardant360 test, but I'd imagine that for those that do, it will be They'll be diagnosed at a later stage. So how are you thinking about this playing out in 2021, probably more in the second half? And is this something you can act upon proactively and forecast in 2021 or not so much? Thanks.
Yes. I mean, I think it's difficult to assess exactly how much of a backlog effect And I'd said, we see that so many patients still are not I think there's still a lot of room to grow even outside That backlog, whether it persists or not. So I think that's why I think we're very bullish in terms of Continued volume increase in terms of Guardant360 as well as potential other products down the line. And so there's we're still very much in the early innings of adoption of these types of tests.
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.