Guardant Health, Inc. (NASDAQ:GH) Q1 2022 Earnings Conference Call May 5, 2022 4:30 PM ET
Alex Kleban - VP, IR
Helmy Eltoukhy - Co-CEO
AmirAli Talasaz - Co- CEO
Mike Bell - CFO
Conference Call Participants
Puneet Souda - SVB Securities
Dan Arias - Stifel
Jack Meehan - Nephron Research
Yih-Ming Tu - Morgan Stanley
Derik De Bruin - Bank of America
Kyle Mikson - Canaccord
Mark Massaro - BTIG
Max Masucci - Cowen
Patrick Donnelly - Citi
Julie Qin - JPMorgan
David Delahunt - Goldman Sachs
Brian Weinstein - William Blair
Hello everyone. And welcome to the Guardant Health First Quarter Of 2022 Financial Results Call. My name is Charlie, and I'll be coordinating the call today. [Operator instructions] I'll now hand over to your host, Alex Kleban, Vice President of Investor Relations to begin Alex, please go ahead.
Thank you. Earlier today, Guardant Health released financial results for the quarter ended March 31, 2022. Joining me today from Guardant are Helmy Eltoukhy, Co-CEO; AmirAli Talasaz, Co-CEO and Mike Bell, Chief Financial Officer.
Before we begin, I'd like to remind you that during this call management will make forward-looking statements within the meeting of federal security laws. These statements involve material risks and uncertainties that could cause actual results or events 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 of the company’s annual report on Form 10-K for the year ended December 31, 2021 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 GAAP. 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 forward-looking statements, whether because of new information, future events or otherwise. This conference call contains time-sensitive information and is accurate only as of the live broadcast, May 05, 2022.
With that, I’d like to turn the call over to Helmy.
Thanks Alex. Good afternoon and thank you for joining our first quarter earnings call. I will begin the call today by providing an update on our progress across oncology. I will then turn the call over to a AmirAli for an update on our screening program and finally, Michael provide a more detailed look at our financials.
At Guardant, we are dedicated to helping patients across all stages of cancer live longer and healthier lives with the data provided from our powerful blood tests. In line with this commitment, I would like to start off with a patient story. In 2018, a 54-year old man was diagnosed with rectal cancer and had a successful surgery to remove his cancer. About three and a half years after surgery during a regular checkup, oncologist ordered a Guardant reveal test, which detected CTD signalling had a high likelihood of disease recurrence.
Because of this result, his oncologist decided to monitor him more closely and within a few weeks, determined he had a clinical recurrence. His oncologist then ordered a Guardant360 test, which revealed he had a number of alterations, including her to amplification.
Given this information, the patient had a number of potential first line treatment options targeting the HER2 Amplification. He was able to start treatment immediately and I'm happy to report that he is doing well. This is a great illustration of how the Guardant portfolio of products is increasingly working hand in hand to help inform patient treatment across the continuum of care.
Now turning to our performance on Slide 3, we ended the first quarter with revenue of $96 million up 22% over the prior year quarter. Our team delivers strong clinical test volume reaching 27,100 tests an increase of 47% from the prior year quarter. This was composed of a somewhat slow start in January and February due to the Omicron surge, followed by a very solid finish to the quarter in March, setting us up very nicely for the second quarter and a very strong grant for the rest of the year.
Moving on to Slide 4, I am proud of our team's work to established Guardant as the leader in liquid biopsy for a high performance test results and excellent customer service. Since the launch of our first product Guardant360, we have been focused on building relationships with a growing number of oncologists. We now have more than 11,000 ordering oncologists and within this group, we are seeing our core base of customers ordering more tests and using more Guardant products each quarter.
This is evidence of the depth we are building into these accounts and that drives adoption of CGP and unlocks more of the TAM over time. This in turn allows us to expand our portfolio and fuel, which positions us for long-term sustainable growth. We believe there is ample opportunity to continue growing both in terms of comprehensive genomic profiling and liquid biopsy share.
Last month, we announced a partnership with Epic, a widely used comprehensive electronic health record system in the United States to integrate our broad portfolio of cancer tests and enable our tests to be available to over 250 million individuals with a patient record. This integration will make it easier for health systems, community healthcare providers, and retail health clinics to make our blood tests part of routine clinical care by providing direct ordering access and results delivery.
We are proud of our team that is delivering on this initiative in a very condensed timeline, leveraging knowhow and lessons learned from across the sector. This is just the first of a number of partnerships that we are exploring to better integrate our products into clinicians workflows that will include additional EMR systems among other tools. We are also making progress in the reimbursement front. In early March, we received Medicare coverage for Guardant360 TissueNext test under the Moldex LTD.
We are already seeing that reimbursement of our tissue product accelerating the positive trends we have been seeing of increased depth of ordering per account has now more and more oncologists are ordering multiple products from Guardant and as a result, this is deepening our touchpoints and amplifying our overall brand awareness in the market.
Looking more closely at recurrence monitoring on Slide 5, we continue to be excited by the positive response to our Reveal assay, especially given where we are in the project cycle. The MRD space is still in the very early endings and we continue to hold a singularly unique space as the only commercially available lead only solution, despite a whole host of tissue-dependent entrance. We are very pleased so far with our progress since launch and the traction we are getting in MRD with our unique blood [ph] only assay, we believe we are on track and have all of the products and commercial elements necessary to be the leader in MRD.
Specifically, we continue to see strong quarter-over-quarter growth and are very pleased with our launch trajectory, with a respect to the competitive landscape and our previous product launches. We expect to have a series of future tailwinds, including indication expansion, reimbursement, and clinical utility data arriving, that sets us up well for long term growth.
Turning to Slide 6, outside of the United States, we are continuing to broaden our reach to deliver a new paradigm of cancer care to patients around the world. In mid-March, we were excited to announce that the Japanese Ministry of Health, Labor And Welfare approved the use of Guardant360 CDX in patients with advanced solid cancers. The Guardant360 CDX test was also granted approval as a companion diagnostics, identify patients with microsatellite and stability high, solid tumors who may benefit from Keytruda and patients with MSI high advanced colorectal cancer who may benefit from Opdivo.
It's regulatory approval has taken on added significance as CRC is the most commonly diagnosed cancer in Japan and this is globally the first liquid biopsy approval for IO therapy.
This follows prior regulatory approval for Guardant360 CDX from the Ministry of Health, Labour and Welfare in December of 2021 as a companion diagnostic for identifying patients with metastatic non-small cell lung cancer, who may benefit for treatment with [indiscernible]. Following this approval, we are now working to securing public reimbursement by the end of 2022.
Japan represents a very large market opportunity with about 400,000 late stage patients compared to 700,000 in the United States and similar reimbursement rates for CGP. We are now in the process of building a commercial footprint to serve this enormous opportunity.
We are also moving to quickly establish our footprint in the European market, as we are seeing early track to the hospitals and doctors with programs in the United Kingdom and Spain. In fact, this month, our laboratory in partnership with Vall d'Hebron in Spain, will launch and be officially operational. We look forward to being able to provide local access to Guardant360 in the region, ensuring that no cancer patient globally is left behind.
Moving on to biopharm on Slide 7, we delivered 5,100 tests in the first quarter representing growth of 45% year-over-year. We ended the quarter with more than 110 active partnerships, reflecting a growing and diverse set of customers. The breadth of our product offering, strong customer service and our clinical market leadership makes us an attractive partner. We have a healthy pipeline of discussions and expect the number of customers to continue to grow over the course of the year.
We are also seeing growing interest for our Guardant and form offering further driving our mission of being a partner of choice for biopharma. We have now signed several deals for Guardant form spanning applications from translational oncology to clinical development and study planning and have seen strong growth in the number of partners and customers we are talking to with regards to this platform.
Turning the Slide 8, earlier this year, I shared our vision for our smart liquid biopsy platform. We continue to make excellent progress towards this launch and are seeing strong initial interest from our biopharm partners. We are encouraged by their early feedback and excitement on its capabilities that are profoundly more rich than any liquid biopsy oncology products in the market today.
Diving a bit deeper into the platform, what defines all the diverse cell types in our body is not the genetic sequence information itself, but everything beyond that, such as epigenetics and other markers. We expect this product to redefine drug development enabling for the first time that greatly expanded views with an underlying tumor biology, to which the field in general has been largely blind due to the lack of available tools.
It's still early days, but we are beginning to witness first-hand the power that deep multimodal interrogation of cancer pathways will have on development of next generation precision medicines, and are very excited for the countless applications possible from this new platform. We look forward to sharing more about this next chapter of our smart liquid biopsy platform at Investor Day planned for the fall of this year.
Before turning the call over to AmirAli, I would like to take a moment to talk about what drives us at Guardant. One of our most important values is to put the patient first, everything we do has to be led by that north star.
Another core value is blaze a trail. With the momentous launch, our screening test shield a few days ago, we've now spent almost a decade putting these values into practice to make blood based cancer testing across the entire continuum of cancer care a reality. We've made countless difficult decisions along the way, all to develop the right technology and product market fit to bring our vision to fruition. We learned along the way that as a company, when you blaze a trail, you have to constantly innovate and disrupt to deliver progress often displacing incumbent technologies and companies like we did with Guardant360 eight years ago Guardant revealed last year, and this week with SHIELD.
This generates excitement and attracts new investment to propel more innovation. We've seen this in the form of billions of dollars in capital invested by financial markets and competitors into blood-based testing. Disruption also triggers reactions at time. All of this is evidence that we are very much on the right track and leading the nascent industry. I am very proud of our team, our products and this exciting next chapter of Guardant Health.
I will now turn the call over to AmirAli, to provide an update in our screening program.
Thanks, Helmy. Turning to Slide 9. At Guardant, we've always believed that a blood-based screening test during wellness checkups has the potential to shield patient from cancer. We've been on a 10-year journey to bring a high-performing blood-based screening test in the market that can save millions of lives worldwide. For colorectal cancer, our core belief is that even the blood-based test, combined with a high level of early-stage detection is the key to improving screening compliance and making our vision a reality.
This has the potential to improve health equity and access to screening for underserved populations. I'm so excited to announce that we are now officially on the market with our LDT tests and only a short distance away from showing pivotal results in ECLIPSE and filing for FDA approval.
Starting with our Shield LDT test, launched this past Monday on Slide 10. This is truly a seminal moment for the Guardant and the availability of the Shield test represents a major milestone in our commitment to transform cancer screening. We have developed highly sensitive technology to detect early-stage cancers with a simple blood draw.
We are pleased to report the following performance metrics. Overall sensitivity of CRC detection of 91% at specificity of 92%. The specificity of 94% in screen negative normals, which excludes early adenomas. Early-stage sensitivity of 94%, Stage 1 sensitivity of 90% and Stage 2 sensitivity of 97%. And advanced adenoma detection of 20%.
The clinical performance of the this assay was validated using a set of 309 patient samples, including 92 in CRC, 62 in advanced adenoma and 166 normal cases. CRC patient samples were accrued across 6 unique cohorts collected in the U.S., Canada and the EU. And samples with a advanced adenoma in normal cases were collected in the U.S., mainly from the same colonoscopy sites participating in the ECLIPSE trial. Subjects were balanced by age, a mean of 64 years old and gender. If the ECLIPSE readout is close to our LDT performance, we are confident that Shield will become the leading noninvasive CRC screening methodology.
Turning to Slide 11. The recent LDT validation results are shown together with prior studies that we have reported in past conferences. This demonstrated producibility of overall sensitivity, early-stage performance and specificity. Moving on to Slide 12. One notable item is the assay's performance in advanced adenoma detection. This is the result of a new R&D pipeline that was ramped up over the past year using a proteomics approach. It has yielded solid results in providing advanced adenoma detection and also has a slight boost to early-stage CRC sensitivity. Importantly, we were able to include this upgraded technology into the assay we are using for ECLIPSE.
We believe our Shield blood test has the potential to be much more effective in reducing CRC mortality and adding more life years gain than any other stool-based screening test. Throughout the history of Guardant, we have dealt with several skeptics who claim that blood test cannot add value in oncology. And every time they have been proven wrong. And liquid biopsy showed it can, in fact, transform precision oncology.
Current recommendation of USPS CRC screening strategies are based on models that have 100% adherence. However, we've seen studies with real world evidence showing much lower adherence rate for stool-based test versus blood-based test. In a peer review publication, shown in Slide 13 from Harvard Medical School in 2019. The effectiveness of different CRC screening tests were modeled under gas option. 100% adherence rate and compared to reported real world adherence rates in this publication.
On the left-hand side in this chart, assuming 100% adherence, FIT-DNA with 3-year interval and FIT with 1-year interval, averted 42 to 45 CRC cases and 25 to 26 CRC deaths. Colonoscopy 46 cases and 26 tests and SEPT9 with 3-year interval, 35 cases and 23 deaths per 1,000 individuals.
Now the right-hand side is assuming reported real-world adherence. SEPT9 averted more than 30 CRC cases and 19 CRC deaths. Colonoscopy 34 cases and 20 deaths, FIT-DNA and FIT 16 to 25 cases and 10 to 16 deaths per 1,000 individuals. It's interesting to note that SEPT9 demonstrated superiority in adherence adjusted effectiveness despite its low performance of 68% CRC sensitivity, 22% of advanced adenoma sensitivity, with only 80% specificity.
The key takeaway here is that with real-world adherence levels, stool-based testing would mean almost perfect performance to massive effectiveness or clinical benefit of blood-based tests. Therefore, we believe our Shield blood test has the potential to have a higher benefit assessment by USPSTF than any other school-based screening tests.
Turning to our ECLIPSE trial on Slide 14. The patient journey in ECLIPSE is broken into multiple stage gates. On our last earnings call, we shared our progress with patient enrollment and collecting colonoscopy and pathology reports to reach our target number of confirmed CRCs. We have designed this study to receive a certain level of positive CRC reports, and we are still waiting on a number of those to come in.
At this point in time, delivery of pathology reports from the centralized pathology review board has been slower than we expected. We are doing everything we possibly can to accelerate these as quickly as possible. We now expect the readout for ECLIPSE to be in the second half of the year with the September, October time frame as a likely case.
We have already started our modular submission to FDA and are planning to submit our PMA application by end of the year, pending successful ECLIPSE readout. We believe we will be the first to have a blood-based cancer screening test with Medicare coverage and FDA approval. Post approval, we have the opportunity to secure ADLT status for this test. And with PAMA, we are confident that we will be able to secure Medicare pricing of over $500. We are clearly operating in a very different environment than 8 years ago, and I'm confident about our pricing strategy.
We expect this test to reach favorable long-term gross margins of around 60%. Through sales and marketing efficiencies, powered by higher adherence and patient refresh for blood testing we believe we can be a profitable company within a couple of years following USPSTF guideline inclusion.
Moving on to Slide 15. Colorectal cancer screening is just the start of this journey. We will soon expand into multi-cancer screening, including lung, pancreas and others, where we believe cancer screening can save lives. Recently at the American Association for Cancer Research Annual Meeting, we presented new data demonstrating the ability of our next-generation Shield multi-cancer assay to accurately detect early-stage cancers. This assay is designed to analyze approximately 20,000 epigenomic biomarkers that are informative for detection of a wide range of solid tumors in a single blood test.
The data for 4 cancer tests were demonstrated as examples for the rectal, lung, pancreatic and bladder. In addition, the blood test identified the tumor tissue origin with high accuracy. By adding new indications to our blood test, the test benefit and the resulting life year gain should further improve. Once commercially available, this indication expansion will be a major catalyst for our Shield assay. We believe Shield will be the patient referred CRC screening method at launch as that indication expansion will even further accelerate its adoption relative to stool-based tests. Completely transforming the screening market from what it is today.
With that, I will now turn the call over to Mike for more details on our financials and outlook for 2022.
Thanks, AmirAli. Turning to Slide 16. Total revenue for the first quarter of 2022 was $96.1 million, up 22% from $78.7 million in the prior year quarter. Total precision oncology testing revenue for the first quarter was $84.1 million with growth of 32% compared to $63.7 million in the prior year quarter.
This increase was driven by strong year-over-year growth in both clinical and biopharma central volumes. Precision oncology revenue from clinical tests was $66.0 million of 32% from $49.8 million for the prior year quarter. First quarter clinical test volume was $27,100, which is an increase of 47% from the same period of the prior year. After the COVID peak at the start of 2022, we finished the first quarter with good momentum. We also continue to see strong uptake for our new clinical products, REVEAL, TissueNext and Response and we expect volume from these products to continue to increase as we progress throughout the year.
For the first quarter of 2022, the ASP for Guardant360 was in the 2,600 to 2,700 range, which is consistent with the last few quarters and the blended clinical ASP was approximately $2,450. While we expect Guardant 360 ASP to be stable in 2022, the blended clinical ASP will continue to be impacted as reimbursement of new products will take time to ramp up. We were very pleased in the first quarter to receive Medicare reimbursement for TissueNext at $2,920. But as a reminder, we don't expect our new products to start to significantly contribute to revenue until they receive Medicare and private payer reimbursement.
Precision oncology revenue from biopharma tests in the first quarter totaled $18.1 million, up 30% from $13.9 million for the prior year quarter. Biopharma volume was strong with first quarter samples totaling 5,100, which was up 45% from the prior year quarter. Note the volume was 23% lower than the fourth quarter of 2021 due to the positive seasonality in the biopharma business that we encounter towards the end of each calendar year. Biopharma and sample ASP in the first quarter was approximately $3,600, down 10% from the prior year period, was in line with the fourth quarter 2021 due to a similar product mix.
Development services and other revenue in the first quarter totaled $12.0 million, down 20% from the prior year quarter. Compared to the fourth quarter of 2021, development services and other revenue was down 38%, primarily because fourth quarter 2021 revenue included royalties for the 8-month period from May to December whereas first quarter 2022 revenue, including royalties for the 3-month period January to March 2022.
For the remainder of 2022, we will continue to recognize royalties on a quarterly basis. As we've previously highlighted, while we continue to see strong demand for our development services, several companion diagnostic projects were successfully completed in the second half of 2021. And as such, we expect that our quarterly development services revenue will be lower than prior year for the next few quarters as new projects take time to ramp up.
Gross profit for the first quarter of 2022 was $64.1 million compared to a gross profit of $49.9 million in the same period of the prior year. Gross margin in the first quarter was 67% compared to 63% in the prior year quarter. The change in gross margins primarily due to development services and other revenue, where the gross margin improved from 65% in the prior year quarter to 89% in the first quarter of 2022.
Operating expenses for the first quarter of 2022 were $187.5 million, an increase of 19% compared to $157.8 million in the first quarter of 2021. Non-GAAP operating expenses exclude stock-based compensation and related payroll tax payments, acquisition-related expenses, amortization of intangible assets and contingent consideration.
Non-GAAP operating expenses for the first quarter of 2022 were $158.7 million, a 58% increase from the $100.7 million in the prior year quarter. This increase was driven by the significant investments made over the past 12 months in our commercial infrastructure and in the continued development of our product pipeline and clinical data across both oncology and screening.
Throughout 2022, we will continue to invest in progressing our strong pipeline of oncology products as well as in generating clinical data to support their reimbursement. The screening, 2022 investment will be focused on the commercial launch of our Shield LDT test, completing the data readout from ECLIPSE, the PMA submission for our CRC device and the continued development of our multi-cancer screening test.
Net loss attributable to Guardant Health common stockholders was $123.2 million or $1.21 per share for the first quarter of 2022 compared to $109.7 million or $1.09 per share in the first quarter of 2021. Non-GAAP net loss was $93.2 million or $0.91 per share for the first quarter of 2022 compared to $49.4 million or $0.49 per share for the first quarter of 2021.
Adjusted EBITDA was a loss of $86.6 million in the first quarter of 2022 compared to $45.4 million loss in the first quarter of 2021. We define adjusted EBITDA of non-GAAP net loss attributable to Guardant Health adjusted for interest, income tax, depreciation, amortization and other income and expense. We ended the first quarter of 2022 with approximately $1.6 billion in cash, cash equivalents and marketable securities.
We feel we have a strong cash balance that can support our ongoing operations for the foreseeable future. and which gives us flexibility to continue to invest in our business to drive robust future growth. As a reminder, we previously shared our decision to exercise our call line to purchase the 50% of the Guardant Health EMEA joint venture shares that we do not currently own. We still expect to complete this transaction before the end of the second quarter of 2022.
Now turning to our revenue outlook for the full year 2022 on Slide 17. We continue to expect revenue to be between $460 million and $470 million, representing growth of approximately 24% over 2021 at the midpoint. As a reminder, embedded in this guidance range are a few key assumptions. First, we expect clinical oncology sample volume for the full year 2022 to grow by more than 50% compared to 2021, and biopharma volume to grow by at least 30%.
As a result, we expect precision oncology testing revenue to grow more than 35% over the prior year, with higher growth expectations for the second half of the year versus the first half due to the reduced impact from COVID and improved reimbursement of new clinical products.
Second, we expect development services and other revenue to be approximately $50 million for 2022. Finally, while we are excited about the launch of our Shield LDT test, we are not expecting significant revenue contributions from it this year. We are continuing to make great strides across our business broadening our product portfolio with our Shield LDT test and expanding our reach into the cancer screening market.
We are aggressively pursuing the best opportunities ahead, and we are confident that we will be a leader in cancer across the continuum of care.
At this point, we will now open it up to questions.
[Operator Instructions] Our first question comes from Puneet Souda of SVB Securities.
So first one, primarily on the Stage 1 and 2 performance for Shield CRC screening that was remarkable at sort of the 90% and 97% that you had, obviously, well ahead of anyone that -- I mean, anyone was expecting sort of that number. And if I look at that performance, I mean do you -- the main question from investors at this point is really, do you expect that data to hold up in the ECLIPSE trial?
I know it's sort of hard to speculate, and you've given a number of point around validation study in cohorts and some of the samples from the ECLIPSE side. But sort of -- does this give you enough confidence that the performance on the sensitivity side is going to hold?
Obviously, we are very excited with the Shield LDT launch, and the fact that performance across independent cohorts, some of the samples actually we are running obviously for the first time. And especially for the sample sets, CRC side, the samples came from United States, Canada, Europe that data is holding up under early stage.
We continue to see reproducibility on the assay over time over different reagent batches, all the things that basically could contribute into technical variation of the assay, we are very pleased with that. And on the specificity side and the sample there even much, much, much closer to actually what we expect in ECLIPSE, as I mentioned in the prepared remark how the samples came, in fact all the examples came from many sites who naturally are contributing, in fact, in the ECLIPSE trial.
So in terms of expectations, still the same that I always mentioned, I think so far, what we've seen on the early-stage side, high 80s, low 90s. And now we'll see what ECLIPSE is going to have for us. On the specificity side, samples are much, much closer to really intended use statement now. So I think we have a very good understanding of specificity at this time.
Okay. That's great. And just a follow-up on that. Thanks for really clarifying the modeling and the questions that have been raised around sort of the USPSTF and potential coverage after USPSTF. But just to boil that down that modeling study that you showed. I mean, is it safe to say if the sensitivity of liquid biopsy is strong?
Obviously, the ease of use of a simple blood draws are strong and the sort of the performance that you're seeing at sort of the 90% and 30, 92% specificity that even a 20% advanced adenoma data, and I appreciate that, that had some more larger confidence interval around it. But even with the large confidence interval as long as USPSTF is modeling and including the adherence adjusted that you have no doubt that this would be covered by commercial payers. I just want to be clear on that point.
So our current understanding based on everything that we look at, in fact, actually it's interesting, you look at 2021 USPSTF writings from that communities, but it's -- the awareness is there that adherence is obviously a parameter. It has not been always FIT and Cologuard kind of models. It's been -- I assume adherence is like 100%, but they know that and they reference based on real-world experience, obviously, adherence is not 100%, we wouldn't have the issues we are dealing with probably not having any blood test. There were no issues with patient preference and adherence.
So tha's why everybody is well aware of this. And now we need to do our work to make sure we continue to publish papers on the modeling and show the importance of adherence, which is the reality of the business we are running. That's the way to save lives to make sure patients would comply and adhere to these kind of tests year after year in terms of like every 3 years for by sustaining to the test. They need to test almost -- the impact of it with a life year again would go down.
So it's notable that it's not that we need for sure to have adherence in the model in order to show positive life year kind of gain and contribution in this field. Like all these kind of tests with the performances that we are talking about based on our assessment and over time, you're going to show our understanding of models over time in different conferences that we are going to talk to you guys.
They are close by. When you add actually adherence, I think that they also become significant based on our understanding. That's almost like stool-based test need to detect everything in order to release lack of compliance and adherence to really have similar kind of life gain contribution to patient population. That's our current understanding at this time.
Our next question comes from Dan Arias of Stifel.
AmirAli, just to maybe follow up on that. Can you just kind of recrystallize what you said and clarify whether you think that real-world adherence will be considered as the USPSTF guideline consideration? And that you think that, that is what will drive a 3-year interval for the test rather than a 1 year.
Yes, sure. These models actually -- the time in terms of that goes into models, actually, there are kind of public information. You can just solve those modelings in fact, and kind of see what goes into it. Adherence is a parameter there. And it's been noted that so far when they look at stool-based test since all of them in terms of adherence, they have similar ballpark kind of issues.
That's our kind of at least assumption why they haven't really look at that here in a meaningful way. Everything just model went simple like 100% versus when we are talking about a new mode of screening that it's the main value that, hey, this is a patient-preferred blood-based test with the potential for much higher adherence, much higher compliance.
Obviously, that needs to be a factor. And for sure, it's a parameter in the models. But so far, it's been used just as a kind of a placeholder 100%. And as I mentioned, if you look at 2021 write-offs, they say even that renal adherence is not 100% based on some real-world evidence. But so far, in a modeling exercises that they've done, they went with that simple assumption.
Yes. Okay. And then can you maybe expand a little bit on cost and the COGS associated with Shield? And then how that aligns with the economics of testing, either on an annual basis or a 3-year basis? And then along those lines, the extent to which you just think you achieve price competitiveness with some of the other tests that are on the market.
Yes, we're confident about our pricing strategy that it's clear based on ADLT obviously that expanding 3-year pricing. We -- after FDA approval, we are going to be qualified, we expect we are going to be qualified as ADLT post the FDA approval. And the pricing advantages that you get with ADLT, I mean the way the pricing gets set up. I think that's great upside for our side.
Now if -- and then the manager pricing historically came. Diagnostics has been really the indicator of some of the conversations with private players in terms of price entering for software private players. And there are a bunch of stories around that and how the Medicare pricing helped with those negotiations. And in fact, some private payers who kind of have pricing issues, there are stories of how comps might actually handle this.
So I think this favorable PMA -- half of kind of rates, which is not come as a result of ADLT for this test post hopefully successful with FDA would really set the top line. But if you go with the assumption that our longer ASP damage is 500$ we are building this assay on our operation in such a way that with ASP of $500, we are going to have 60% plus gross margin.
And we know that's possible. In fact, the way chemistry works, the way process engineering and investments we've done so far would show us that at scale, we can get to those COGS points, and we are going to our P&Listen-only mode with 60% margin. Even if you just go with $500 price.
Our next question comes from Jack Meehan of Nephron Research.
Wanted to move over to the oncology side of the business, start with Guardant Reveal. I was wondering if you could provide an update just how the discussions are going with MolDX around potential reimbursement for that test?
Yes. I mean we've asked. We've essentially submitted everything that they've requested, and we're just waiting right now on kind of their feedback on that information. So nothing there -- nothing new to report at this time.
Okay. And if I look to the 27,100 clinical tests in the quarter, I just kind of triangulate based on the ASP commentary Mike laid out. It seems like you had about 2,000 or so all other tests beyond Guardant360 in the quarter. Is there any way you can just provide a little bit of color around like what's the largest within there between Reveal, TissueNext or Response? And then off that, how does the reimbursement work for TissueNext, did you start getting paid for that yet?
Yes. I think, firstly, on TissueNext reimbursement, we received the positive coverage in Q1. So I think we'll expect to be able to recognize revenue from the Medicare side of things in Q2 going forward. And then for the volume, I think your numbers probably are a little bit short on the new products. I think we've seen really good traction across the board.
Without breaking them out, I think it's fair to say that Guardant Reveal is really ahead of those new products, and that's because it's been on the market for just over a year now, the products were launched in middle of last year. But again, we've seen really solid traction. We're really pleased with the volume, both on the core Guardant360 business, but also, yes, with the new products, and so a really strong year-over-year growth that we've seen on the volume.
Our next question comes from Tejas Savant of Morgan Stanley.
This is Edmund on for Tejas. The first question on the new version of the Shield test, it requires less depth sequencing and obviously, the price of sequencing per GB has gone down with the emerging players and Illumina's new chemistry. So I was wondering to what degree were these 2 factors, the less depth of sequencing and the lower price of sequencing or GB. So what degree will that provide an offset to the margins for this product?
So in terms of our road map to get to that $200 [indiscernible] that I mentioned, we had scale. In fact, that's based on the current economics of sequencing dollars. The sequencing part is material part of our deal of material, but not it before our COGS impact. That's why like what we need to deliver on that. It's not a future activity, a bunch of stuff already happened, but we need to continue making progress is, in fact, on process engineering and automation versus reliance on new chemistry that would be top sequencing pricing to get to that cost.
If you know what you're doing in the field of NGS and you have some level of good experience that I'm happy with the type of caliber talent we have at Guardant. Sequencing can be run actually very efficiently in terms of the total COGS planning.
So I imagine, in facts future to surviving actually screening tests would -- majority of done with, in fact, with heavy rely on NGS, and in fact, they could keep their COGS really on their control in this market. So in short, definitely any single dollar saving for further sequencing cost reduction, we would take it in terms of gross margin improvement. But it's not that we needed in order to get to 60% margin at scale.
Got it. And then a follow-up question. With the Epic agreement, it's good to hear that the integration is going well. But how are you expecting this to impact ordering patterns? And specifically, with the inclusion of Shield, does this change your expectations about its revenue contributions ahead of the FDA approval?
Helmy, do you want to start with the impact of -- and then I can...
Yes, I can start. Now we're very excited about kind of this partnership. We think it's going to be a big boost to certainly, our oncology portfolio as well as Shield down the line. Increasingly, as these tests become standard of care, being able to integrate in Epic and really have that ease of ordering really removing sort of barriers and friction in terms of that process is going to be a big boost and a big catalyst for volume for years to come. Epic is one of a number of partnerships that we're exploring right now. And so we see a future where all of our products are very highly accessible across the electronic health record ecosystem. And then I'll let AmirAli comment on kind of impacting on Shield.
Yes. defensively look, we are very excited about all the advantages in terms of workflow. Advantages when you're dealing with EHR, EMR, which has such a high -- relatively high penetration in our installed base. And on the screening side, definitely, we are heavy on electronic ordering even today based on LDT launch that we have a bunch of those of our operation, which we are excited and very excited that this EHR kind of connection with further make our customers happy in terms of ease of ordering.
In terms of revenue contribution, I just refer back to what Mike mentioned that mainly because of low ASPs before FDA approval, we don't expect material revenue contribution of Shield this year. But we are just very few days post LDT launch, and we are pleased with what's happening just in a matter of a few days.
Our next question comes from Derik De Bruin of Bank of America.
Derik De Bruin
A follow-up on the last one, just on your commercialization plans and how you're going to roll this out? And also just to compare your plans based upon there's obviously another multi-cancer detection test that's been -- that's out there is an LDT right now. And you sort of look at their approach on doing concierge and going after that. Could you just sort of talk about what your commercialization plans are. How you're going to do it and sort of like what the costs are going to be and how much sales force you need? I'm just -- I think that's where we're getting a lot of questions from investors is just once you sort of go beyond the data, how do you get the commercial rollout and the costs associated with it?
Yes, sure. Actually, at Guardant and our commitment is to make sure patients at all classes would get access to our Shield product. And definitely, the business impact of it is we are after unlocking this $20 billion CRC screening market opportunity. And they mentioned that multi-cancer indication would give on top of that. In order to really unlike that $20 billion opportunity and go after that $110 million, $120 million kind of patient population who are eligible for CRC screening.
You need to have a path for reimbursement guideline inclusion. And that's the path that we are taking. As a result, our commercial plan is very different than some players who are just generating access for their test for a highly privileged individual who can just do self-pay. We have issues with it and we don't believe that's the path to $20 billion opportunity. The number of patients who go into that category is obviously a manufacture of this $110 million.
Now in terms of commercial strategy behind this is, obviously, we are heavily engaging primary care physicians, key hospital systems and employers. We are in an LDT launch phase with about 100 people commercial team all in. And over time, we would expand it at scale to about like 700 people as we get closer and closer to the USPSTF guideline inclusion. So you can expect over time in a systemic and thoughtful way you would scale, obviously, based on some of the additional information that we get in terms of getting closer to the FDA approval, getting closer to the USPSTF, but our plan is to have that in-house 700 people or so commercial team.
The way that this P&L is going to look different than I think maybe stool-based P&L is, look, the patient preferences this blood testing the adherence, we expect to be much higher than stool-based testing. As a result, S&M efficiency per sample would be much, much higher. Now combined us with 60% gross margin at least even with ASP of 500. We think we are going to have a profitable guidance a year or 2 right after USPSTF inclusion -- guideline inclusion.
Derik De Bruin
Great. And just my follow-up question is this is can you clarify your -- why you pushed out the readout for Eclipse? Is it a pathology backlog? Or because you haven't hit enough CRC cases and need to enroll more patients? Could you just a little clarify that? I've got some of those investors that are a little bit -- that want a little bit more of an expansion on that.
Thanks for asking. Because there are a lot of stuff that's going well this excitement around that LDT I have to say, it sounds great. We are waiting for this ECLIPSE read out to come out. I think it's going to be a defining moment for patients for a full industry like we work on this think for years now. We are waiting for this thing to happen, and we are doing our best to make sure we get to that point sooner than later.
Now in terms of the main contributing factors like still we are waiting for -- like a, unfortunately, the details of this trial operation is complicated. And there is central pathology review that needs to look at all disease cases that we are finding in the colonoscopy cases. And there is still a few thousand cases in the backlog of that review that needs to happen.
So based on number of CRCs we found, the reports that we got, the backlog of that centralized pathology and a bunch of stuff that we are doing to increase the productivity. But for such a regulated study that's still that single large centralized pathology review is very important. Now we expect the readout to be second half. And the best guess is around September or October time frame, but we think now instead of midyear, that's going to be sometime after. It's -- we are waiting for it. We are doing the best. Our team is on it. We are doing the best that we can. We are waiting for this thing to come. And we just think to now wait a little bit.
Our next question comes from Kyle Mikson of Canaccord.
Congrats on the quarter. So just similar to the question before. I just wanted to know if you could kind of walk through your confidence level that the AA sensitivity, the 20% from the sample sale on Monday. Is that reproducible just given the other screening products have seen degradation of over 15 percentage points. And so it's obviously going to be a big swing factor for FDA and so forth. And so I just wanted to get your sense there.
Yes, sure. So the nature of advanced adenoma that's the reason which we have a much lower number of samples for training and for this validation, much lower number of samples is like advanced adenoma cases, it needs to come from colonoscopy session effectively, right? So the people who go to colonoscopy, in fact, a fraction of these advanced adenomas are for the patient who are going like, obviously, through colonoscopy, and we are getting blood sample from their colonoscopy. So in terms of really the clinical indication, I mean, it could not be like closer than this in terms of ECLIPSE.
In terms of variation, I think it's just a confidence interval around this 20%. We have 51 advanced adenoma data that we are seeing like about 20% sensitivity. So when you look at the confidence interval around it, that's just a statistical variation. And obviously, ECLIPSE is going to quantify the exact sensitivity since we have already identified over 1,000 plus kind of advanced adenomas. We are going to have a like a very fine tune. So that confidence interval, we showed it in our LDT press release.
I'm hope I'm not misquoting but that confidence interval is from, I think, 12% to 32% when you go from 20% out of 51%. So -- but that's the issue of low end. We just need higher-end advanced adenoma to figure out. In terms of degradation, I mean, these are coming from screening sites effectively. So it stood the same kind of advanced adenomas to a large extent.
#Perfect. Our next question comes from Mark Massaro of BTIG.
There seems to be some sufficient confusion out there in the marketplace. But I wanted to just maybe get to the basics. There was that CMS memo January 2021 that specified that CMS would cover any blood-based test at sensitivity and specificity of 74 and 90, but it also cited a test interval of once every 3 years. So I guess -- I know that's a CMS question, but do you have any doubt or material doubt that you can't obtain once every 3-year interval from CMS?
We do not doubt about it based on everything that we know. So I think NCD is NCD. In fact, you know what's the bar of changing NCDs that like these stuff changing FC, that's why typically, CMS and CAG do not publish NCDs. The bar of changing NCDs, in fact, very high. So NCD language is very clear. I think one thing that maybe -- maybe I take this opportunity that maybe there is not also high awareness around it. Like the way CMS looks at it like specificity of 90%, our understanding, in fact, is like -- they want to make sure that the specificity is better than Cologuard and that 90% is coming from 89.8% from Cologuard study when you exclude advanced adenomas.
So effectively when you just get specificity in completely negative samples. So when we are talking about our specificity numbers, like, for instance, in this LDT. Like it's not that 92% for LDT. That includes some early adenoma, it's like when you exclude that. So in fact, that 90% the FDA or the final readout of ECLIPSE let's say could be, in fact, a little bit lower, but more of 90% is that. So -- and we feel based on the threshold that we set. Hopefully, we are going to get there, with ECLIPSE trials easily. But I would tell.
Great. I recently put out a survey where 75% of docs indicated that they were likely to order a new blood-based test even if it was not recommended by USPSTF. So I guess, I would be curious if you think that that's reasonable relative to some of the survey work you've done. And then there's been a lot of pushback about your 20% AA sensitivity. Can you walk us through how you think you can gain uptake? Notably, it seems like AA is not at the front in mind of many primary care physicians. It seems like it's FDA approval and overall sensitivity and specificity. But help us think about how you can get to a $500 price and get into USPSTF even if your AA is not above what Cologuard is.
Yes. So actually, I think those maybe on [indiscernible], maybe a few things at the same time. So in terms of the PCP, we talked about our market research and the clear top thing for them is CRC performance, advanced adenoma still in terms of awareness of differentiation of different products. I think in mid to longer term, that could be a parameter, but those are research-based, and you're just very few days into the market. I tell you what we are hearing today in very, very early days is, in fact, strong confirmation of what we've said so far.
But again, this is just a 3-day conferential activity, and maybe we can have the same conversation 3 to 6 months from today. We cannot be more pleased with actually what we are hearing from the market and confirmation of what we think would really drive the adoption of blood-based tests and how much market is waiting for such tests to come to the market. That's the reality.
In terms of the requirement for USPSTF, I tried to cover it in the prepared remarks. But the most important thing, they look at 3 things. One is clinical evidence. That's why we are doing ECLIPSE. Second, they look at benefits and harm. Lack of compliance is on top of many people's minds. So it's something that it's not that it's a high bar of education or awareness around that.
Adherence, there's a good understanding. In fact, I mentioned it's a parameter in the modeling. So based on our exercise that hopefully, in near future, we can show the way the models are working in our end based on what we've seen so far. We are going to have a very positive life share gain again offered with liquid testing. We are in the ballpark of other tests, reasonable ballpark.
And then when you include adherence, I think it's not even close. And I doubt if you are making mistakes. So when you incorporate adherence, actually, the blood-based test shines very strongly with what we are talking about. So that's our current understanding of USPSTF.
I think CMS and FDA recovered it before the bars are kind of relatively very clear in terms of requirements and the precedence and like the primary endpoint of our FDA studies, clinical trial go, it's all-around CRC performance and advanced adenoma is a secondary finding in ECLIPSE trial. But we are excited with this performance that we've shown so far. That's why we even upgraded our assay with this latest and greatest asset that we have on the research side. And now we see what ECLIPSE is going to us.
Our next question comes from Max Masucci of Cowen. Max?
Just a quick follow-up on Mark's question. I think the NCD, it states that it will provide coverage for any qualifying test, either once every 3 years or at the interval designated in the FDA label if the FDA indicates the specific test interval. So just curious if you're expecting the FDA to recommend a specific interval when they rule on the ECLIPSE data and if they do, how that would -- how that recommendation would play into USPSTF's eventual ruling on the test interval as well?
Based on actually what I know with the FDA in the label and kind of indication. I would be surprised if they get into like kind of interval testing. So this is not our expectation in terms of like for the experiences we have with other products like data getting screen interval testing of when or how or how often use let's say Guardant360 CD those conversation never even came up. It's all-around safety and efficacy of the treatment. And now how often used, there are some other elements, including health economy kind of argument that comes to the picture and the added benefit of those tests, your test relative to other tests.
Listen, the way we are looking in the mainstream is people know that lack of compliance is a major issue. And people are noticing blood-based cancer screening can -- as a potential for a tremendous population and health benefits. So people out there in mainstream are trying to help instead of trying to make sure blood-based screening test is not going to be something that the U.S. citizen would get access to it. So in fact, many stakeholders, like just look at the NCD, I'm not sure if it ever has done to have a finalized NCD before anyone even qualifies for it. So I think there are many efforts in the field, in the mainstream to make sure patients would get access to these life-changing diagnostics, and we are very excited with that.
Got it. USPSTF, obviously, assuming 100% adherence in some of the models to support the recommendations, but they clearly acknowledge the importance of adherence in the real world. So if you're looking across health care advocacy groups, guideline bodies, regulators, reimbursement decision makers, which of those parties do you expect to be the biggest advocate for the use of adherence adjusted modeling, especially when they're determining the role that your test could play in underserved populations and other individuals that are in lower income areas.
It's our relationship and we are excited with our partnership with multiple patient advocacy group in this front. This is something that -- again, like the whole mainstream and ecosystem is trying to make sure, in fact, such game changing life saving tests get out there successfully. And we can really increase compliance rate well over 80% with these kind of devices, but high sensitive high-performing devices, not just devices. But the only thing they can do is late-stage detection.
So it needs to be the right device too. I think everybody on the mainstream and the stakeholders and influencers are in alignment. There are some former USPSTF members that are in our advisory board. We are kind of discussing with them, brainstorming we've done about strategy and it's also on the top of the mind kind of makes sense to them.
But obviously, hey, you have a good life year kind of a gain in terms of impact. And when you consider the reality of the problem today, which is the problem of compliance problem of adherence when you incorporate those, like the model would clearly show you why blood can add value in a very tremendous way. So because we have lack of adherence and lack of compliance. But it's not that that's the only way to get positive life year gains shown in the model. But once you include it, the delta, it goes in a lot favor in a very big way. Based on what we've done the modeling so far, that's hopefully in the near future, we would talk about it.
Our next question comes from Patrick Donnelly of Citi. Patrick.
I'll just keep it to one. I know it's run a little late. AmirAli, maybe just on the ECLIPSE delay, just following up on the earlier question. Just to be clear, it sounds like it's just kind of the review running along. You guys are still confident the sample size is correct. And then on the back of that, how quickly can you turn the PMA submission around? It sounds like you're still confident that happens in '22. So the timeline on the FDA side doesn't sound like it's slipping. I just wanted to confirm that. And again, confidence level and the ability to turn that around relatively quickly.
Yes. So maybe I start from the last part of your question. And based on our planning, actually, we still believe we can submit our PMA package to agency this year. There are a bunch of analytical clinical validation that stuff needs to happen and based on the reality of what's happening on the clinical side. The project planning gets adjusted in terms of the kind of sequence of experimentation and so forth. So we feel that this year, we can submit our final module of our PMA to agency.
As I mentioned, we started the modular submission already. So we are -- the reviews started, in fact, for us for some of our early modules. And in terms of the timeline delay, this is -- there are many things that we are executing great. And this is something that obviously, not good to see. This is not something we are happy about. Obviously, there are some stuff which is -- we are doing our best to increase the -- what happened in the centralised review board, which is outside Guardant the way to be to really go through this backlog sooner than later, but it's -- these are the details of complicated trial operation.
And we are doing our best. We are on it to minimize this timeline delay. We need to get to our CRC number, the CRC number that we having mind for this study to be powered, and we are still a few more to go. So we have a few more to go, and we have to go through this backlog and then we see. So -- yes. Many things we are executing very nicely, and I'm very excited, but this is something that really is not good. And -- but we are honored that we are doing our best to rectify and get this data as soon as possible. I think all of us are waiting for this for so long.
Our next question comes from Julie Qin of JPMorgan.
So maybe just a quick follow-up on Shield. I know you made a very clear point about the importance of compliance in terms of guideline reviews. How much important do you think USPSTF we put on AA performance? And I assume that you talked about using an improved version of the assay for this later study. So I assume there are additional levers you can pull to further enhance the AA performance as well. Just wondering if you can get any color in terms of the theoretical, how much theoretical improvement potential there is for a performance?
Yes. So actually, we are pleased with where we are in terms of the current region of the test, CRC like we worked on it all along, like many samples like the performance like even close to even what we've seen so far, gets validated, with ECLIPSE, with advanced adenoma performance that we've shown. We believe we are going to have a leading test for colorectal cancer screening in terms of number of cases that in long term are going to be ordered, we think our test would be the preferred and leading assay.
Having said that, is this the best, and there is no way to kind of improve the test in terms of advanced adenoma performance, I cannot make that time. In fact, I tap in to Guardant360 experience like the way that test was 8 years ago versus today, there are a bunch of performance improvement, 1 advantage of having multitude sample collection from ECLIPSE is around test, versioning and potential upgrades. But I -- we think what we've seen with LDT if it gets confirmative we are kind of in a very good shape.
In terms of USPSTF, so it's a complicated multifactor model, CRC sensitivity plays a role the advanced adenoma detection plays a role in energy stage adenomas in terms of detection play a role there adherence and compliance and follow-on kind of plays a role. And I think we talked about it. So once you add that adherence, like I think, blood-based test, we believe it's going to have much higher life year gain save versus any store test now.
Our penultimate question comes from Matthew Sykes of Goldman Sachs.
This is Dave on for Matt. Congrats again on the Shield launch. Can you give us an idea of the order of magnitude of Shield volume you expect next year. It looks like the 1 multi-cancer screening test in the market is expecting around 80,000 or 100,000 tests in its full year.
So maybe actually give us some time for the next year guidance. I can tell you that actually what we are seeing in the very few days of this launch is actually a lot more than what we expected. So -- but we have to see like even based on what we see looks like there's been a bunch of underestimation of what it would be then with this such a limited commercial team. So -- but we are not ready at this time to talk about next year guidance for sample volume on Shield. This is very new for us. So we need to understand this better. But so far, so good, I can say. We will keep you posted.
Got it. And can you tell us a little more about how you arrived at the $900 cash pay price.
Yes. So obviously, we talked about the value of the test and for the people who are going to actually offer some cash basis, we need to establish a list pricing and this cash pricing would be something which is going to be important in terms of the track record of payment for us when we go to the ADLT and pricing for ADLT, post FDA approval. So we are setting some groundwork spread. So please stay tuned.
And our final question comes from Brian Weinstein of William Blair.
I was just going to ask you about that pricing question as well. Maybe it's a substantial premium to Cologuard. Just was thinking through that, and thinking through with the ADLT, you obviously will get reviewed on that pricing based off of what you're seeing on the private side. Do you expect that you will be able to contract with private payers ahead of inclusion in quality metrics?
And then I'll just ask the second one right now just because it's a short one. In near time do you guys expect that there will be any kind of FDA panel review for this, given this is kind of a new class, and we're going to have, I think, 3 or more that will be coming this is kind of a short period of time.
Maybe, again, I start from the last part of your question, Brian. So in terms of panel review, the FDA decision on what they want to. But I don't agree 3, 4 devices will come at the same time. In fact, what we know -- we are going to be at least quarters away from anybody else trying to submit their package. So just a notion that there would be multiple submissions at the same time and joint review even for 360 CDx that we got approval with foundation on liquid like you have a month away from each other, I've had an experience that kind of notion of are review for a brand neo liquid biopsy for treatment selection by agency.
So we cannot comment on a bunch of, I think, maybe to some extent. -- random statements that's coming to our market from different annuals. So in terms of actually reimbursement expectation, it's -- the reality is FDA would enable CMS coverage, Medicare coverage shortly after obviously would a to ask for Medicare Advantage coverage.
There is always some early players that actually would jump on it post Medicare. There is, I think, some players that with jump on it post-potential ACS guideline inclusion. But we as like the default expectation would be many of the private payers would jump on the ship right after USPSTF guideline inclusion. So that's our expectation at this time.
At this time, we have no current questions. And therefore, this concludes today's call. Thank you all for joining. You may now disconnect your lines.