Good afternoon. Thank you for standing by. Welcome to the Guardant Health Second Quarter 2021 Earnings Conference Call. At this time, all participant lines are in a listen only mode. After the speakers' presentation, we will have a question and answer Please be advised today's conference is being recorded.
I would now like to turn today's conference over to Carrie Mendiville, Investor Relations.
Thank you. Earlier today, Guardant Health released financial results for the quarter ended June 30, 2021. If you have not received this news release or if you'd like to be added to the company's distribution list, please send an e mail to investorsgardenhealth.com. Joining me today from Guardant are Helmy Altucchi, Amaralie Talazaz and Mike Zell. Before we begin, I'd 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 Certainty 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 of 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 discuss 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 today's 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 is active only as of the live broadcast, August 5, 2021. With that, I would like to turn the call over to Helmy.
Thanks, Carrie. Good afternoon and thank you for joining our Q2 2021 earnings call. Our mission at Guardant has always been to ensure patients have access to innovative Today, the vision is clearer than ever, and I've never been more excited about the opportunity ahead of us. This afternoon, we announced a new leadership structure which will allow us to aggressively move and scale into new areas of growth across the continuum of cancer care. We have created 2 focused areas within Guardant, oncology and screening.
AmirAli and I will serve as co CEOs With AmirAli leading our screening efforts and me leading oncology. We believe this leadership structure will provide the focus and strategic attention required To continue as the liquid biopsy leader in oncology, while aggressively pursuing the massive opportunity in cancer screening. This structure will also allow for scalability to address new areas across healthcare beyond screening and oncology. Everything we do at Varden is motivated by our commitment to serve patients. We are dedicated to bringing the absolute best Products to market that will provide clinically actionable information to inform patient care.
We believe that this new focused leadership structure will allow us to more rapidly address And in line with these commitments, I will start off today with a patient story. Last March, a 68 year old woman was diagnosed with colorectal cancer. Shortly after her diagnosis, surgery was performed followed by adjuvant therapy. In follow-up, our oncologists detected elevated levels of CA, but she scanned negative for evidence of disease. And another follow-up just over a year after the initial diagnosis, her oncologist ordered a Guardant reveal test which showed she was ctDNA negative.
Guardant revealed directly measures tumor derived DNA in the blood while Gardner Beal has a sensitivity of 91% compared to the CA test with a sensitivity of 69%. With a higher sensitivity than CA in the surveillance setting, Gardner Ville showed the patient was not actively progressing. This story highlights how Gardner Ville can Now turning to our 2nd quarter performance. Revenue grew 39% The product was $92,000,000 2nd quarter clinical volume grew to 20,830 tests, representing 52% growth over the prior year period and up 13% from the Q1 of this year. While patient visits and office access are still not fully back to pre COVID levels, We are pleased with how well our commercial team is continuing to execute in this environment and still achieve healthy volumes.
International clinical Volumes were impacted by the resurgence of COVID cases, especially in countries where the vaccination rates remain low. During the Q2, we saw strong growth in U. S. Clinical volumes Oncology offices gradually reopened throughout the quarter. However, in recent weeks, we have seen a reduction in oncology office visits And Salesforce Access in the United States and across our global business, which may have an adverse impact for the remainder of the year.
Although we have started to see some impact globally, we have not seen much yet in the United States. We are monitoring the Our portfolio is growing quickly and we have launched a record number of new products and product Great in the last year alone, but we are nowhere close to done. 2 of these new product launches were announced in the second quarter, Guardant360 Tissue Net and Guardant360 Response. Both products expand the custom Guardant360 portfolio to offer oncologists end to end testing solutions. TissueNet supplement our blood first approach.
Our TissueNet test provides an integrated solution for oncologists to use liquids first ahead of tissue, ensuring patients receive guideline complete testing with the fastest turnaround time. In oncology disorder is an integrated product and begins with the Guardant360 liquid biopsy test. If there is no biomarker Here she is able to quickly reflex the tissue with TissueNEXT. This integrated approach has a significantly higher biomarker detection rate than tissue alone. In the FLIP study in non small cell lung cancer, CGP liquid testing using Guardant360 identified 81% of patients with informative test And tissue testing found informative biomarkers in the remaining 19% of patients.
On the other hand, Standard of care tissue testing alone identified just 57% of the patients with an informed test result in this study. This study is one of many that highlights a blood first TissueNept approach offers a clinically superior paradigm. The early response to TissueNept has been very encouraging. The reimbursement path for tissue is well defined and we expect to submit the technical assessment application to MolDX this year. We believe this offering will serve as a Guardant360 Response is the 1st commercially available blood only liquid biopsy test that detects changes in ctDNA levels to provide oncology Our comprehensive product portfolio essentially enabled our oncologists to perform Profiling for treatment selection in both blood and tissue as well as response monitoring.
Feedback for both new products is very positive. We do not expect either product to be a significant revenue contributor in the near term as we work to establish reimbursement. Turning to our occurrence monitoring opportunity with Guardant Reveal. We are pleased by the encouraging feedback and reception from oncologists. Based on the early success we are seeing in the market around our deal, we have expanded this dedicated commercial team.
More than 9,000 colleges have ordered a Guardant360 test We are leveraging these existing customers as well as our relationship with KOLs for their launch of REVEAL. Beyond CRC, we are also making great advances in other cancer types compelling data on bladder, lungs and now breast as well. Moving on to biopharma. Biopharma volumes grew to 3,653 tests, up 30% year over year and up 4% from the Q1. We continue to experience some pressure in biopharma sample volumes given the lag in many of the samples coming to us for analysis Due to slower enrollment during COVID peaks.
Q2 Development Services and other revenue was approximately 19,500,000 Up 27% year over year. We are pleased by the growth of our overall pharma business and continue to serve an increasing number of biopharma customers with more than 80 active partnerships. As our biopharma business matures, we expect growth to be underpinned by sample volume, Including new product introductions, for example, multi indication reveal as well as companion diagnostics. This quarter, we announced 2 new companion diagnostic approvals with Janssen and Amgen, both for use in advanced non small cell lung cancer. Daphne has approved the Guardant360 CDF test as the 1st and only liquid biopsy companion diagnostic for comprehensive genomic profiling to Moving on to Guardant and Form, a real world evidence platform featuring an extensive clinical genomic liquid biopsy data set Advanced cancer patients.
We have signed more than a dozen biopharma collaborations for Guardant and Form since its launch just over a year ago. We are pleased with the success and growing interest from our biopharma partners in this offering. At Guardant, our sites are set not only in providing We are focused on establishing ourselves as a best in class company in these large markets while maintaining a culture of fast execution as the organization continues to scale. Since founding Garden, AmirAli and I have always had a Strong partnership and we've been laying the groundwork for these 2 focus areas of oncology and screening for quite some time. This co CEO leadership structure is a continuation of our current strategy and supports the evolution of our business.
We are scaling the team to The growth of both businesses and recently brought on Chris Freeman as our new Chief Commercial Officer of Oncology. We expect to bring on several more key leaders in the near future and have started building a dedicated commercial organization for our Having leadership teams dedicated to each opportunity will give us the focus and velocity to rapidly scale in Recent changes and additions to our Board of Directors. I will now be serving as Chairman of the Board and AmirAli will continue to serve on the Board as the Director. We believe this rotation and responsibility adds a fresh perspective and is in line with our overall focus to scale our organization. In addition, Megan Joyce has been appointed to our Board of Directors.
Megan is the Chief Operating Officer and Executive Vice President of Platform at Oscar Health, A high growth health tech and health insurance company where she leads operations, technology, clinical, marketing and new business lines. Prior to joining Oscar Health, Megan had several leadership roles at Uber, most recently as Regional General Manager of the United States and Canada. Our expertise in scaling high growth organizations will be invaluable to our next phase of growth. We look forward to our contributions and guidance. We are committed to continue to develop a portfolio of breakthrough products across all stages of cancer and ensure these innovations are not only available, But readily accessible for all patients.
We look forward to continuing to expand our product portfolio, attract and develop top talent And improve patient outcomes as we conquer cancer with data across the continuum of care. I will now turn the call over to AmirAli.
Thanks, Helmy. I want to start by echoing Helmy's excitement A successful readout of our ECLIPSE trial will potentially open up a $20,000,000,000 screening opportunity in colorectal cancer. And future studies will open up opportunities in additional cancer types, paving the way towards a Total addressable screening market of more than $50,000,000,000 We are confident that we will become the leader in screening, requires a dedicated and focused effort. I'm thrilled to assume the role of Co CEO As we position ourselves for the launch of our screening business, we are encouraged by the progress in the CRC indication, And this is just the first of many indication we will pursue for screening. I'm excited to announce That we have recently enrolled the 10,000 patients in our ECLIPSE trial.
I'm proud of the progress our clinical team made in running this study during the pandemic when enrollments in many Clinical trials were heavily impacted. Now based on the CRC prevalence that we see in Eclipse so We plan to enroll an additional 3,000 patients in this study for a total of 13,000. To ensure we reach the required number of CRC positive patients, we are confident that we will have total In parallel to running Eclipse, we are also making great progress building our commercial infrastructure to launch our screening product. I'm pleased to announce that we are planning to launch the LDT version of our CRC screening assay in The first half of twenty twenty two, and we expect to launch the IBD version of the assay in 2023, pending Successful FDA review and approval. The initial version of our screening test will be for CRC, And we expect over time more indications will be added to the assay.
We have presented data and are continuing to Good technical performance in detecting early stage lung, bladder, pancreatic and a few other cancer types in pilot cohort study. Part of our strategy is to invest in adjacent areas or emerging trends that are synergistic to our efforts To that end, we have recently partnered with Lunet, a company focused on AI powered radiology Turning to clinical data. At this year's ASCO Annual Meeting, We presented about 20 abstracts covering our full suite of products. I would like to highlight a few of these abstracts In an MRD study led by UCSF in oligometristatic CRC patients, Guardant's reveal was used to analyze post procedure ctDNA in serial blood samples in 46 patients. Positive predictive value of positive post procedure ctDNA to predict recurrence was 96%.
And on average, ctDNA was detected 28 weeks before radiographic recurrence, Mean of 17 versus 45 weeks, respectively. Pfizer also presented data leveraging Guardant360 to assess ctDNA dynamics as a predictor of airway response. In newly diagnosed advanced non small cell lung cancer patients treated with Lorlatinib, Guardant360 was able to We also reported clinical outcomes from patients in the NILE study. Patients who received target therapy based on their Guardant360 results at comparable outcomes to those treated based on tissue results. Importantly, time to treatment in ctDNA cohort was Significantly shorter compared to the tissue cohort, 18 versus 32 days, respectively.
Lastly, in another abstract covering early stage cancer management using cancer specific genomic and epigenomic signals, Patients with early stage disease and 171 self declared healthy donors. Sensitivity for non small cell lung cancer was 70%, Stage 1, 56%, Stage 2, 80% And Stage 3, 83 percent and sensitivity for bladder cancer was 51% in non muscle invasive, 36 percent in muscle invasive, 69% with 95% specificity. These abstracts demonstrate the value and utility of liquid biopsy across the continuum of cancer care. With that, I will now turn the call over to Mike for more detail of our financials.
Thanks, Maher Ali. Total revenue for the Q2 of 2021 was $92,100,000 up 39 from $66,300,000 in the prior year quarter. This growth was driven by a year over year increase in both our precision oncology testing revenue and our development services and other revenue. Total precision oncology testing revenue for the Q2 was $72,600,000 A growth of 42% compared to $51,000,000 in the prior year quarter. Precision oncology revenue from clinical tests in the 2nd quarter was $61,100,000 or 54 percent from $39,600,000 for the prior year quarter.
2nd quarter clinical test volume, which primarily consisted of Guardant 360 tests, was 20,830, which is an increase of 2% from the prior year quarter. In the Q2 of 2021, the average estimated ASP The Calumet 360 CDx and LVT test was approximately $2,600 which was in line with our Following the April 1 increase to $5,000 of the Medicare reimbursement rate for Guardant360 CDX and the partial offset from potential payment delays or denials of the new Guardant360 CDX ADLT code from private payers. For the remainder of 2021, we expect the estimated ASP for Guardant360 CDx and LVT test To continue to average approximately $2,600 Note that the clinical revenue recognized in the Q2 of 2021 Consists of accrued revenue for tests performed in the period based on the estimated ASP as well as cash collected for tests performed in prior periods The cash collected was greater than the previously accrued revenue. As our ability to estimate the ASP for Guardant360 continues to improve due to our growing We expect clinical testing revenue for the second half of twenty twenty one to be primarily derived from And therefore, the amount of revenue recognized from cash collected for tests performed in prior periods will be significantly lower than in the first half of twenty twenty one.
Precision Oncology revenue from biopharma tests 2nd quarter BioPharmaTest totaled 3,653, up 30% from the prior year quarter. BioPharmatest ASP was $3,163 down 22% from $4,054 in the prior year period, Strong growth driver and in the 2nd quarter totaled $19,500,000 up 27% from the prior year quarter. Development services revenue included milestone payments for the 2 FDA companion diagnostic approvals we received in the Q2 of 2021. Gross profit for the Q2 of 2021 was $62,200,000 compared to a gross profit of $43,900,000 in the same period of the prior year. Gross margin was in line with our expectations and in the second quarter was 68% compared to 66% during the Q2 of 2020.
Operating expenses for the Q2 2021 were $159,800,000 an increase of 62% compared to $98,500,000 in the Q2 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 contingent consideration. Non GAAP operating expenses for the Q2 of 2021 were $124,700,000 a 71% increase from 70 $2,900,000 in the Q2 of 2020. We expect operating expenses to continue to accelerate in 2021 As we invest in our LUNAR program, the clip study and other development activities, as well as expand our commercial organization, both in our oncology business, Where we have launched several new products so far this year and in our screening business as we prepare for the planned launch of the LDT version of our CRC screening assay in the compared to $54,600,000 or $0.57 per share in the Q2 of 2020. Non GAAP net loss was $61,400,000 or $0.61 per share for the Q2 of 2020 Compared to $23,500,000 or $0.25 per share from the Q2 of 2020.
Adjusted EBITDA was a loss of $56,400,000 in the Q2 of 2021 compared to a $25,100,000 loss in the Q2 of 2020. We define adjusted EBITDA as non GAAP net loss adjusted for interest, income tax, depreciation, amortization and other income and expense. We ended the Q2 of 2021 With $1,800,000,000 in cash, cash equivalents and marketable securities. Now turning to our revenue outlook for the full year 2021. While we feel bullish about the trajectory of our business and again saw record revenue this quarter, we want to be cautious given the uncertainty around the impact of COVID-nineteen and in particular the delta variant on oncology office visits, clinical study enrollment and sales source access in the U.
S. And across our global business. Therefore, we are maintaining our guidance of $360,000,000 to $320,000,000 Representing growth of approximately 27% over 2020 at the midpoint of the range. We continue to expect clinical sample volume for 2021 to be greater than 90,000 tests, representing growth of at least 42% over 2020. At this point, I would like to turn the call back to Helmy for closing comments.
Thanks, Mike. Before closing, I want to thank our team for their incredible work this quarter as we work to establish ourselves And our product portfolio and establish our solutions as a class in cancer testing. We are looking forward to bringing this momentum into the second half of the year. With that, we will now open it up to questions.
Thank you. And our first question will come from the line of Tycho Peterson with JPMorgan.
Hi, good afternoon. This is Julia on for Tycho. To start off, maybe you can spend a little bit more time on the new leadership Obviously, we all understand that screening is a different animal from oncology in terms of reimbursement I am on go to market channel, etcetera. So with this leadership structure change, like what specific operational changes can we expect For the cancer screening business, especially in terms of resource allocation and financial reporting. I know you touched on commercial team Expansion is a major part of it, but are there any meaningful changes in the OpEx outlook or the long term strategy we should be thinking about?
And Helmy, I think you mentioned in the beginning that there are potential opportunities beyond screening and oncology. So just wondering if you could elaborate a little more what
I'll start and then I'll let Marillyn kind of fill in on the spending side. But This is really a culmination of changes and an evolution of the organization that has been ongoing For the last several years, and I think it really is a testament to the confidence we have around screening, around our separate businesses And the scalability of the future that we want to set up. Malabhavir, you talked a little bit about the screening side of things.
Yes. So I'm thrilled with this additional responsibility, and I believe it would generate actually There are a bunch of corporate matters that are beyond these two businesses that we are kind of confident. So definitely, As always, we're very close partners and still operate under One Guardant entity business operation that we have. Just wanted to make sure we have more focus and dedication across different business lines that we are going to run. I think
I think in terms of the second part of your question, I think this structure also allows Scalability beyond the areas that we're targeting today. We're not making obviously any announcements around those areas, but we do know that our platform Really has the legs and I think the capabilities of addressing other areas of health, but more to come in the future.
All right. I guess we'll stay tuned. And then separately, I have a question on the G360 response test. Just curious, since you already have REVEAL, what's the rationale for launching response as a separate test instead of having a single Quantitative MRD test. And then a related note, I've got several clients asking this.
Does the response test Any cannibalization on G360?
So the response is really, I think, a Very well targeted product. If you think about therapeutic response, most targeted immunotherapies are really targeted towards Advanced cancer patient market. And so to you're really constraining 2 different animals that don't belong, MRD And therapeutic response. So this is absolutely the right product for the field. We're seeing really a lot of excitement in terms of The launch of this test, we have a wealth of data over 40 publications that really support the science and the clinical utility and clinical ability of this application.
And it's really part and parcel to, I think, what we laid the groundwork for Now I think over 5 years ago, in terms of our tumor response map, you make a decision, a physician makes a decision in terms of which Treatment to put advanced cancer patient on, for many reasons, the current standard of care is Less than stellar in terms of determining and understanding whether that patient will respond or not, especially to therapies like immunotherapies. And the Guardant response can come in and just a few weeks later, essentially that test is able to help with adjudication Determination of that patient is indeed responding or not. So it's a fantastic product that Sits squarely in kind of the unmet need that exists today in the advanced cancer patient market. So we actually see it as an amplification Of our current products, not cannibalization in any way.
Great. Thank you.
And our next question comes from the line of Doug Schenkel with Cowen and Company.
Hey, good afternoon. Thanks for taking my Just going back to the leadership structure change. Clearly, the opportunities are large here and complex, Even acknowledging that, this leadership change is, it's a bit unusual, especially in this space. Again, I know the opportunities are big, but I mean we could get on the list of bigger, more diversified growth Companies in life science tools and diagnostics and none of them have this structure. And this includes very successful companies like Thermo, Danaher, Agilent, just Name 3.
And I could probably name 15 to 30 more. So recognizing part of leading a company is being decisive and nimble and ultimately having one person at the helm. What precedent can you point to that How did the Board make a decision that this was the right thing to do when no one else in the space has? And often and this is really important, Co CEO structures lead to eventual single CEO structures. Usually, these are temporary when we've seen them in other areas.
Helmy, this seems like it could be a sign that you're likely to leave the CEO role at some point relatively soon. Are you committed to this current role through 2022? This seems very, very important given how many clinical readouts and how many
Yes. Just to put it kind of bluntly, I'm not going anywhere and Firmly committed to Guardant, as is AmirAli. It would be crazy to leave when we have so much opportunity to address So many patients. I don't see another opportunity, frankly, in existence that could really match what we have on our plate. I think this is Really an acknowledgment of how much focus, how much mind share it really takes To win, to succeed in these ambitious areas where we're addressing.
I mean, we're addressing 3 areas of oncology That have been grandstanding challenges for outstanding challenges for decades. And it takes really singular focus to really open up these Huge TAMs that exist in each one, dollars 20,000,000,000 $30,000,000,000 TAMs, dollars 50,000,000,000 TAMs. And with due to all due respect I don't think they're necessarily solving some of these complex challenges we're addressing here. No one thought that liquid biopsy was a viable technology when we started Guardant. And there is a lot in terms of how we've succeeded in the past.
That is bucking it's about bucking the trend and Doing what is right for the business and what is right for patients regardless of tradition or what has been done in the past.
Okay. Super helpful and I appreciate you Giving us a little bit more on the thinking behind this. Now maybe just for a couple more near term questions. And I'm sorry if I missed this in your prepared remarks. I understand that guidance factors in the reality of the environment We're in that there is still some uncertainty as it relates to what's going on with COVID and specifically the Delta variant.
And recognizing that, I'm wondering if you can say anything about what you saw over the course of the quarter and what you've seen In the early part of the second half of the year in terms of ordering activity and your ability for the sales force to actually get in
Yes. So I think as we mentioned in our remarks, We actually saw improvement during the quarter. We saw offices opening up. We saw more access, Which I think is part of the driver in terms of the strong quarter that we had in Q2. I think what we've started to see, especially in the last few days, is some of these offices are starting to restrict access, starting to close back up.
And that's not surprising given where really the number of cases are per day now in the United States, how fast Things are rising. And so it's certainly something that despite the strong progress we're seeing, the momentum we're seeing, We wanted to be, I think, cautious in terms of the second half of the year because we're still in the summer months and Who knows what happened, especially in the winter. I don't know if Mike is there anything else?
Well, maybe just also to reiterate, where we did see a little bit of impact was in the International business, of course, that's not the large piece of our business, but we saw an impact there. And again, I think we've seen continued Uncertainty internationally as well. So again, just another reason why we've maintained the guidance
Our next question is going to come from the line of Tejas Devont with Morgan Stanley.
Hey, good afternoon guys. Thanks for taking the time. This is Edmund on for Tejas. The first question I had was on MRD And given the debate around the tumor informed and tumor agnostic assays, Helmy, can you provide us with some quantitative color on how the mind share battle is progressing? I guess in a simpler time, is
there any way you can give us
some information on how many
of your new ordering positions for VBL and RESPONSE
Yes. I think we continue
to see good traction. It's Very logistically straightforward test that really fits in to how physicians currently order Yes. A test like CA and how they practice medicine, it's something that I think we've been very pleased by the traction we've seen with the reveal. We continue to be pleased. There are a number of KOLs who I think have talked publicly in various forums, both In the U.
S. And internationally about the challenges with tissue acquisition, even in the early stage Cancer setting and how having a really tissue independent approach is one that is I think Really simplifies some of those and addresses some of those challenges that exist. In terms of it's obviously hard to get exact Numbers, but we really do not see a lot of pushback, whether or not Physicians have been existing or are new users to these types of tests. And so we're very pleased by The traction that Reville is seeing by the reception that we're seeing with really whole class and the position that we've been in front.
Got it. And I'm sorry if I missed this, but can you remind me on the timeline for reimbursement and the plans to
So I think we've mentioned before that we expect Reimbursement by end of the year for at least on the Medicare side, private payroll, I think will take Sometime as some of the utility studies read out most likely. In terms of multiple indications, It's something that should happen relatively soon. It's we have Data that we've presented at ASCO that shows I think the progress we've made and the excellent results that We're seeing with the platform beyond CRC, we presented data in bladder and lung that's very compelling. And I think we've mentioned in the prepared remarks data on breast as well. So expect to see those in
the coming quarters.
Got it. And one last one for me on Eclipse. Maybe Amir, you guys Show data on cancer patient populations at ASCO. And first, is
it still right to think about Read out timing for
early next year. And second, in terms of the bogey for the eClip's Well, data, how should we think about this in terms
of the cancer patient population data presented at ASCO?
Yes. So as you I mentioned the script. We expect that we will finish the enrollment by November, the original time We have from the beginning with all the ups and downs that we have in this running this trial in pandemic. I'm very pleased with that given this Hi, this is Sean, 3,000 patients. And right after that, I think after a few months, we're going to have to read out the pick list As we mentioned before, so still we are on track to be ready to run those samples when study ended.
In terms of data we presented at ASCO, we're very pleased with continued data generation We get access to additional CRC cohort, cancer screen cohort, Negative or positive findings. We continue to be pleased with the data. I think we updated our data like across multiple cohorts for total of like over 1,000 chases die around 1300 patients that we showed in ASCO There is some kind of uniqueness in Nicholas in terms of being a prospective screening study, 13,000 patients that we find 67 in CRC and nothing can replace that. We continue to always Technically, you risk actually the finding of Eclipse. But at the end of the day, we have to run And see what we're going to see there, but we feel good about it.
And I think time would tell, but we feel pretty good about
Got it. Super helpful. Thank you, guys.
And our next question will come from the line of Brian Weinstein, Morgan Stanley.
Hey, now I'm sorry, just in case anybody is curious, I'm still aware. It's all good. So a couple of questions for you guys. Going back to the new leadership structure here. I definitely heard the questions from Tycho and Doug, but Kind of wanted to dig in a little bit here.
I get why you want to do this, but I am curious about things like Decisions on deployment of capital, decisions on Other kind of corporate matters, who's in charge really? I mean, at the end of the day, where does the buck stop on kind of broad Setting that broader strategic decision making. With the co CEO structure, it's not clear to me kind of who is at the end of the day really held accountable for broader corporate performance.
We've always had a strong partnership Myself and Murali since the founding of Guardant, I think it's pretty clear things are on screening and Murali will be in charge of The stations are on oncology, I will be in charge of. And we're still having essentially Combined leadership structure around other areas and obviously some of those decisions rise to the Board level as well, which is heavily engaged at Guardant. So I rarely see no issues or not a lot of deviation from where things were in terms of business structure. We're very confident that a lot of the strategic decisions will continue to be made in the context of 1Guardant and really 1Mindset.
Okay. And then as it relates To the CRC screening product, the LVT approach, we haven't really seen that before. Can you talk about obviously, you get in the market a little sooner, but is there any other kind of Strategic rationale in terms of data collection or other things that would cause you to kind of go with that LDT approach? And then Are you willing to kind of talk about what your updated expectations are for performance of the assay from in terms of an early In early stage detection as well as advanced antinomol, where you think you guys could potentially come in on both of those? Thank you.
Yes. Thank you for asking about the LDT and the rationale behind that. Actually, we We're still expecting actually
the STI approval of this does hopefully that Chris goes on because
I'll be reviewing 2023, and that would be the major commercial push for us. But Couple of years before that, it would be very important for us to go into the market, start shaping the market the way that we The blood based screening could add social impact and it can impact outcomes for patients in the right way. Jared, experience for the field integrate our test with Bright Health Networks share the experience for people And really add this blood based screening into a bunch of PCP workflows and in Some are key accounts. So it's a very strategic move for us. On the CRC side, I don't believe like some of the Real world evidence would maybe add much into really I don't see any data gap that, that real world evidence would feel in terms of the CRC data.
I think Eclipse would be Very comprehensive by itself. Bunch of other ISDs that we've done and we are pressing to do are really sufficient. If we add some For CRC Research Health Counsel, in terms of performance, all the data that we've seen different cohorts independent during With different cancer centers and KOLs and PIs, we have published them in different conference In a presentation, we are going to continue to do so. You asked about the advanced IDN alone. That's an area that actually we look into extensively.
While we believe that maybe the performance of advanced I think it's not required for FDA approval potential like Medicare reimbursement based on the NCD, But we do believe that performance is important for commercial adoption of the test and expansion of the TAMP. And as a result, we Looking to finding surrogate biomarkers in blood that can have a good sense of security for advanced. As you know, please stay tuned In the right conference setting, we are going to show some performances hopefully there. So But it's an area that we have looked at for some time. Thank you.
And our
next question will come from the line of Derik De Bruin with Bank of America.
Hi, this is John on for Derik. I wanted to Ask about the ASPs, the clinicals. With all these new product launches, Do you see the ASP for clinical going up in 2022?
Yes, it's Mark here. No, I think when we look at the clinical ASP and we were very explicit in the prepared remarks ASP for Guardant360 and so called Guardant360 CDX and LVT. Now this quarter it is 2,600 On the back of the ADLP change. And we expect that to be the same for the remainder of the year. Of course, we're launching new products and reimbursement is going to take time.
So if we take the overall clinical volume And revenue then, yes, the ASP overall is probably going to go down because we're not getting paid for some of the tests. But for Diamond360, it should at least remain where it is. And if we can We collect better from the private payers with the new ADLT code than we previously expected, but some Thank you for some of the time.
Got you. Thank you. And then, you mentioned that the international market, Sequential decline in revenue that was Delta. But going forward, how do you see that growing? And Back in the domestic, like what percentage of the digits are in person?
You mentioned last quarter that it was around 30, 40. I'm wondering how much Improvement there, Sven?
Yes, maybe just on the international. I don't think we said it was sequentially down. What we said is that we saw an impact. And I think we were more referring to The impact on the growth rather than the decline. So we're still I'd say, we're still Seeing strong performance internationally, but we've continued to see impact because we're in many different countries and the impact across those countries It varies.
And again, it's making an impact on our ability to grow the business. Yes, it's not sequential decline.
Yes, I mean, I think things improved from the 30%, probably reached at least 50 And there are more of them started opening up and we're going in the right direction, but obviously we're seeing things Now close back up, I mean, I think yesterday there are 150,000 new cases in the U. S. So clearly, I think there's a lot of justified risk in the part of clinicians given the impact on the cancer patients, advanced cancer patients of this disease.
Thank you. And our next question will come from the line of Patrick Donnelly with Citi.
Great, thanks. AmirAli, just wanted to follow-up on one of the prior questions there, I think it was Brian, talking about the LDT launch. Have you guys kind of carved out a type of population you think will be addressable with this launch relative to the overall pie coming with the IBD launch? I know other companies That have done LDT launches, have carved out a tranche where they feel is addressable with the LDT. I'm just curious your guys' perspective on that.
Yes. So still our population, even for LDT launch would be average risk Population, having said that, we don't expect like major adoption before FDA approval. We believe that stamp of FDA approval, we We're getting multiple coverage policies would continue to We did adoption of this, especially on the mainstream adopter. But we do believe there are a lot of opportunities with early adopters and People who are really interested in a bunch of people that we are working with, they really want to use our test event Sooner than later, so we are kind of responding to some extent some of the market demand too. But now that we are carving out and going just after, let's say, high risk patient population, Of course, we don't have that strategy at this time.
We're going to go into markets still with average risk indication with the Offering that we have, but we are going to see that the way market would react to the data package that we're going to put in front of them and all the evidence that we Generated during the last few years.
Okay. That's helpful. And then, Helmut, I know you mentioned you've seen some This is closing back up over the last couple of weeks. Do you feel better prepared to weather another, let's say, partial shutdown? I mean, are there learnings from the first time around That will help you guys insulate volumes better if this continues to worsen and offices close-up.
I'm just curious if you think the impact this time around would be less Given we all learned something from the first
time around.
Yes, I think certainly our ability to Interact remotely with clinician offices. So we've really built a lot of capabilities in that area, built that muscle. I think the question would be more kind of speed of growth and so on and how that could be impacted. And Obviously, it all depends on severity of Delta and there's other variants that come around. But Yes, I don't expect kind of what happened in Q2 of last year around the industry where People got paralyzed with what happened.
I think we're all living to we're all learning to live, I think, with the disease in the background to some extent.
Thank you. And our next question will come from the line of Dan Arias with Stifel.
Good afternoon, guys. Thanks for the questions. Amira Lee on Eclipse and just expanding the study to 13,000 enrollees, anything you Touch on there just in terms of the need for that move. You guys aren't the 1st company to take the population up for a trial like this. Just kind of curious if it's total overall colorectal cancer patients that you need to increase the number of, is it related to subpopulations by stage or Or is it something else altogether?
Yes. It's related to the number of CRCs that we need to find in that So you can think about it more like United event driven study that there are some certain number of CRCs we need To finding this patient population that we are screening in our first study to be powered to make the claims that we have as part of the acceptance So there is a minimum number of CRC patients that we need to find. When we started the study Based on the prevalence of CRC that we knew at that time, our calculation shows in our data powered study we need 10,000 patients. And as we are enrolled more and more patients and we started actually getting some reports on number of events that we had, Thank you. We like fine tuning the number based on the most recent actual prevalence that we are seeing in this study.
That's why the study is Going from 10,000 to 13,000 to find the additional CRCs that we need to find. That's a driver Indrolling more patients. We see it as
still certainly in line with Where we thought things could play out and then certainly going to conclude in our view within the Time lines we initiated when we first started. So I think we're very pleased by where we are. We couldn't be more thrilled.
Yes. Okay. Thank you. And then just maybe Mike on the mix between Omni And G360 on the pharma side, what direction do you think that split heads in the coming quarters? Obviously, that's got an implication on the ASPs there going forward.
Yes. In this quarter, we definitely saw this weighted more towards the 360. I think as we look for the remainder of the year, we do probably double correct a little bit. And I think our forecast is Probably coming back more on the omni side. And so we're expecting the ASPs to improve a little bit because it was a bit of an outlier It's important.
But a lot of it depends on the pipeline and the samples that we get through the door as well, but That's how we're looking at it. Okay. Thank you, guys.
And our next question will come from the line of Matt Sykes with Goldman Sachs.
Hey, guys. This is Dave on for Matt. Congrats on hitting 10,000 patients in Eclipse, very exciting, As well as the LUNAR-two launch next year. You've been very successful in oncology testing. Screening is an even bigger opportunity, of course.
Could you tell us more about your strategy for ramping sales and marketing To reach the hundreds of thousands of PCPs out there?
Yes, sure.
So We talked about it
a little bit before too. We started actually building the leadership of our commercial channel and screening side Few quarters ago. And now I'm happy that actually we have like a couple of layers of that leadership already in place. It's a dedicated leadership on screening site at the highest level. It was one of our internal executives that we had on oncology site that took The responsibility of leading the commercial efforts on screening side, very now on the individual that we I'm really excited about having him.
And now we have next layers of leadership in place too. As we speak, we are building the next layers to be ready for the Cell DTC launch, and we believe we are going Commercial and all operational infrastructure that we need to support this LDP launch first half of next year.
Fantastic. And could you tell us a little bit more about the AI powered pathology partnership you announced for multimodal screening?
Yes. So the company that we have partnership has partnership with is called on it. There are AI companies in radiology and pathology, very strong team with very heavy experience on AI side, Especially on the image processing. And they have already have some regulated products in radiology side That helps with the productivity and improved productivity of the radiologists in reading different kind of scans on different kind of Scanning modalities. And when you think about what would be the future of screening, we believe that anti blood based assays Are very important, but cannot be the only assets there to really Streamline screening journey for the patients.
So we envision, obviously, a multimodal solution out there That starts with the eye care point would be blood based screening, but there would happen we need to put some kind of additional solution on the front end and Back to really have a great experience and work still for patients and providers To really take open up the opportunities that blood based screening can offer in the field. So we are very excited about that partnership. We're going to work with them to see how much we can shape actually the future activities for them to really help us on the screening side.
Thank you. And our next question will come from the line of Jack Meehan with Nephron.
Thank you. Good afternoon. I was wondering if you could comment on how much Guardant Reveal added in the quarter in terms of volumes. And we're waiting on the Medicare final LCD for MRD. Do you think there's a chance that
you could be included in that? Yes, I mean, there is a final LCD for CRC. And I think the one that is still in draft is the one that expands that and Send that to applications of molecular response as well. And so yes, that is hopefully going to happen Later this year in terms of finalization, but that's obviously up to them in terms of their time lines.
Yes. On the volumes, obviously, we're not splitting out the specific revealed volumes For competitive reasons amongst other things. And we did say in their prepared remarks that the vast majority Of the samples in the volume that we reported were down to 360. I think what we would say again is that the ReVeil Launches gone as well as we could have expected and we're really pleased with it. So the volumes are coming through the door It's good as we expected and we continue to see them grow.
But yes, we're not going to be breaking those out for submission.
Great. Thank you. And then just one math question, sorry, juggling a few earnings points. So sorry if this is A dumb question, but you had $61,000,000 of clinical sales, 20,830 tests. My math was going in $2,900 price point.
I know you quoted $2,600 is there some other dynamic that I missed?
Yes. I tried to explain that in the prepared remarks, but maybe the courage to show you know this. The way that we recognize revenue in the past, there's always been a large sort of cash collection components from samples from Previous periods included in revenue. We're moving more and more to having our revenue just purely based on the improved revenue from the samples In that quarter, so there's still some cash in the Q2 number from prior periods and that's where your math is off a bit.
And our last question will come from the line of Andrew Cooper with Raymond James.
Hey, guys. Thanks for sneaking me in. A lot has been covered. But maybe just first, when we think about the screening commercial sales force you intend to build and the sort of time line on LDT See to FDA. Can you help us a little bit more think about, obviously, it's early today, but where you want to In the first half when you're launching that LDT and then where you want to be again when we think about the timing for the FDA approval.
So just sort of what The stage gate looks like would be helpful.
So a lot of Cyxo's metrics for us during this LDT period is making Sure. Actually, we can build strategic relationship, get into workflows and really build a bunch of Our metrics more than like volume metrics. So and we would be ready that once FDA approval comes, in fact, all the Infrastructure and workflow integrations actually we have built during this period of time would take us to the Maximal opportunity that blood based screening can offer much faster than without this LDT experience. Having said that, we think there is good opportunity with like early adopters and like really this technology and enthusiastic Based on the data that they've seen, in fact, they want to get their hands on this device and start using it clinically. Our main goal, as I mentioned, is for this LDT early launch is to build much of Our metrics and make sure we are well integrated into TCP workflows and Meaning, that's what the network system.
Okay, great. And maybe just one more, if I could. On luted, again, just thinking about sort of the multi modality, I just want to make sure you're kind of thinking about the way you are viewing this Appropriately, they've got Scope. Io that is more on the immuno oncology side and then more of the kind of traditional radiography type Tools as well. So is this something you envision on the front end with the IO piece or maybe the back end in terms of reflexing from a multi The cancer test, how do we think about where this fits into the Guardant pipeline?
I would maybe encourage you to maybe Stay tuned a little bit and we are excited about this partnership and we have our vision of how this multimodal Integrated radiology blood testing could really shape the future. Let us go through that process, and we will keep you Post about the progress that we make, I can just tell you that we are very excited about this future and the way Screening can get streamlined for the patients in oncology and potentially than other diseases.
Thank you. And with that, we have no further questions and we would like to thank everyone for participating on today's Guardant Health 2nd Quarter 2021 Earnings Conference Call. This concludes today's conference call and you may now disconnect. Thank you.