Guardant Health, Inc. (GH) Q1 2020 Earnings Report, Transcript and Summary

Ladies and gentlemen, thank you for standing by and welcome to the Guardant Health Q1 2020 Earnings Call. At this time all participants lines are in a listen-only mode. After the speakers' presentation, there will be a question-and-answer session. [Operator Instructions] I will now turn the call over to your first speaker Carrie Mendivil, Investor Relations. Please go ahead.

Thank you, earlier today Guardant Health released financial results for the quarter ended March 31, 2020. 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 email to investors at guardanthealth.com. Before we begin, I'd like to remind you that management will make statements starting this call that are forward-looking statements within the meaning of federal securities laws. These statements involve material risks and uncertainties that could cause actual results or events to materially differ from those anticipated. Additional information regarding these risks and uncertainties appears in the section titled Forward Looking Statements in the press release Garden 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, 2019, and then its other filings with the Securities and Exchange Commission. 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 that is accurate only as of the live broadcast May 7, 2020. With that, I'll turn the call over to Helmy Eltoukhy, Co-Founder and Chief Executive Officer. Helmy?

Thanks Carrie. Good afternoon and thank you for joining our first quarter 2020 earnings call. Joining me today is AmirAli Talasaz, our President and Co-Founder, and Derek Bertocci, our Chief Financial Officer. Firstly, I hope everyone is in the best of health and in good spirits during these trying times. The world today clearly looks quite different then when we last updated you on our business at the end of February. I want to take a moment to thank our partners in the healthcare community, all of whom are making extraordinary care for both COVID and non-COVID patients in these difficult times. I'm also very proud of the Guardant team for the tremendous dedication and drive they have shown over the past few months, quickly adapting to this new environment. And with this is pandemic, cancer patients, particularly those in late stages of the disease, still need access to information to guide treatment decisions. The Guardant team remains steadfast in our commitment to serving patients and consistent with these values. I will start off our call with a patient story. Two and half years ago, an 86-year-old woman was diagnosed with stage 4 non-small cell lung cancer. Genomic profiling was completed and the patient was found to have an patient was found to have an EGFR exon dilution. Following diagnosis, she was placed on an oral anti-EGFR TKI and responded well to treatment until recently. Approximately 50% of patients responding to a first-or second-generation anti-EGFR TKI therapy while developing T97M resistance mutation, which fortunately is targetable. In order to determine her next line of therapy, protocol just needed a genomic reassessment of tumor. However, given the COVID-19 pandemic and risk-averse exposure. He was reluctant to bring her into the office for testing. Using Guardent's mobile phlebotomy services, he was able to have blood drawn in the safety of her home, and tested using Guardant 360 which identified a T97M resistance mutation. He was able to immediately start her on a new treatment to manage her cancer. Not only does her story demonstrate the importance of the precision oncology paradigm, but it highlights how our liquid biopsy technology and suite of services are uniquely qualified to address the needs of patients during this challenging time. Moving on to our business we ended the first quarter with revenue of $67.5 million, growing about 84% over the first quarter of 2019. During the quarter, we continue to see strong demand for our commercial products. And began receiving payments for Guardant 360 from our local Medicare administrative contractor related to the Pan-Cancer LPD for non-lung test. While our business overall was strong in the first quarter, we did start to see an impact from the site of COVID-19 during the second half of March which continued into April. Due to the ongoing and rapidly changing nature of the COVID-19 pandemic, we are withdrawing our full-year 2020 financial guidance, which we had previously provided on our Q4 2019 earnings call in late February. Even with the impact of COVID-19, clinical volumes for Guardant 360 grew 60% to15,257 clinical tests, compared to the first quarter of 2019. And biopharmaceutical volumes grew 40% to 5,266 tests. Exiting the first quarter, US clinical volumes were down about 30% compared to the average level of clinical samples over the first 10 weeks of the quarter. Cancer treatment, particularly for those patients in late stages of the disease is not something that can be delayed for long. Accordingly, during the past two weeks we have begun to see a slight uptick in sample volume from the lowest points in early April. AmirAli will give further detail on the impact of COVID-19 related to our biopharma business and R&D pipeline. While the immediate future is difficult to predict, we believe that oncology will be less impacted over the medium to long term as compared to other areas across the healthcare industry. It remains our mission at Guardant to conquer cancer with data. And at this pandemic, we have three priorities. Firstly, ensuring the health and safety of our employees, while continuing to serve patients. Secondly, leveraging our own resources to contribute to that effort to combat the pandemic. And thirdly, sustaining investments across our organization so that we are well positioned to support patients and realize the full opportunity of our platform over the long term. Starting with our internal response to the pandemic, our employees' health and safety remain our top priority. Guardant has been designated an essential business that can continue necessary operations during the pandemic. In early March, we probably instituted protocols to about 2/3 of our employees to work remotely. For those employees still in our facilities, we have reduced the workplace density, implemented strict social distancing and other protective measures in order to ensure their health and safety. Consistent with our overall belief that earlier detection leads to better outcomes, we have for several weeks now been operating voluntary repeat COVID-19 testing for our employees which we view as an important step to ensuring their health and safety in our workplace. We also believe that this type of active surveillance testing, capacity permitting, is a model that if widely adopted would be a benefit to many essential businesses across the country. Unfortunately, we believe that currently there exists a major COVID-19 testing gap, both in the United States and abroad. Today in the US, there are only a few hundred thousand tests performed per day, while many estimate a need for five to 10 times that number. We are committed to applying our resources and expertise to help discover solutions and are currently exploring the feasibility of developing our own high throughput diagnostic test for COVID-19 to contribute to closing this gap. This exploration include the substantial effort from R&D to determine our ability to bring such a test to market as well as outreach to potential customers of the test. Even as we explore the viability for Guardant to contribute to the critical testing needed to help fight this pandemic, we remain unwavering in our commitment to serving patients in the advanced cancer setting. Here, we have continued to be focused on shifting the market to a blood first paradigm for genotyping, which we believe will help address that even greater challenges this new environment creates for access to tumor tissue. To this end, we have ramped up and instituted a number of efforts to continue engagement with physicians and patients during these unusual times. In support of these efforts, we have leveraged our existing mobile phlebotomy service that broadens our reach to late stage cancer patients. As the pandemic spreads, we are able to scale up this program and offer home blood draws for Guardant 360, as demonstrated in the patient story I shared at the top of the call, to protect vulnerable patients from possible exposure to COVID-19 and hospitals and doctors' offices. Furthermore, we have initiated an expanded financial assistance program that helps patients affected by the COVID-19 pandemic to ensure that as few patients as possible are denied access to our services during this challenging time. Finally, with our sales force out of the field, we have been successfully engaging our customers through virtual channels. We have been able to leverage our medical affairs team to support customers with clinical consultations over video conference about specific patient cases. Given the challenges of obtaining the biopsy or monitoring patients from progression, we have seen high levels of engagement with their teams due to the unique value proposition of Guardant 360 in overcoming the many barriers that this pandemic as either exacerbated or created. Earlier this week, we launched the clear you review campaign to raise awareness for complete biomarker testing and the critical role it plays in guiding initial treatment decisions for newly diagnosed advanced non-small cell lung cancer patient. This campaign called attention to both the need for complete biomarker testing and the risk under genotyping can have on patient outcomes. In this difficult period, it has never been more critical to match patients with the right therapy the first time. Even in these uncertain times, we are well capitalized to continue to invest across our business, execute on our vision and move into this next phase of growth. We believe that the unique opportunity we have here at Guardant will allow us to serve patients well beyond those in advanced stages of the disease. To realize this opportunity, we are committed to sustaining investments across our platform so that we are well positioned to serve our patients now, through the recovery and over the long term. I'm incredibly proud of the outstanding efforts across our organization, and believe that we will come out of this period even stronger as a company. We are continuing to invest in our team. We recently brought on John Saia as Guardant's new General Counsel. I'm excited to have John is part of the Guardant team and I'm confident in his ability to lead our legal team as we continue to scale our business. I also want to thank Michael Wiley for his many contributions at Guardant. Michael has assumed a new role as Head of Corporate Affairs where he will advance our efforts across strategic initiatives and public policy advocacy. With that, I will now turn the call over to AmirAli for more detail on our efforts on combating COVID-19, our biopharma partnerships and our LUNAR program.

Thanks Helmy. I hope all of you and your families are staying safe and healthy. I want to start by giving a bit more detail about our efforts for COVID-19. As Helmy mentioned, we are currently exploring the visibility of looking at hydro-put diagnostic tests for COVID-19. While we were offering third party surveillance testing to our own employees, we realize there is still a major shortfall with this data testing. We believe there will be significant testing needs around the world for the foreseeable future related to COVID-19. And fell to social responsibility to leverage our expertise to contribute to this need. The test we are developing is a saliva-based viral RNA test to identify active COVID-19 infections. Our test is differentiated from currently available testing methodologies so as not to exert additional pressure on the existing supply chain. Our goal is to offer at least 10,000 tests per day, with the turnaround time of 24 to 36 hours. We plan to offer this assay initial in the state of California to essential workers in the front line setting and underserved communities, as well as employers for surveillance testing of employees. Moving to our core business and starting with biopharma, we continue to experience strong demand for our products during the quarter. In mid-March, however we began to see some delays with respect to certain studies. That said, it's too early to comment on the overall impact of the pandemic on our precision oncology testing for biopharma clients. Biopharma customers are still continuing to pursue companion diagnostic programs, and we have yet to see any slowdown of engagement related to our CDX development services business. Now turning to our LUNAR program. We are continuing to execute against our strategy and invest in this program in order to unlock the significant addressable market opportunities in monitoring adjuvant therapy selection and screening. Starting with LUNAR 1, we are continuing our research and development activities at relatively full capacity, and remain focused on generating evidence based on interventional studies to establish the clinical utility of residual disease testing, which will be a critical component to drive sustained long-term adoption in this space. Now our last earning call, we announced the initiation of our corporate study, a randomized control study aimed to establish clinical utility for the detection of ctDNA in adjuvant setting in colon cancer. We also announced a second study in collaboration with Stand Up To Cancer, MGH and Dana-Farber Cancer Institute, which is a prospective interventional study to manage adjuvant treatments stage three colon cancer patients based on the detection of ctDNA post surgery. While enrollment in both studies has temporarily slowed down, these are multi-year studies and we do not currently expect this disruption to have a material impact on the timing of their completion. Now moving to LUNAR 2. We made excellent progress with our ECLIPSE trial during the first two and half months of the quarter. And now have more than 100 sites on-boarded to enroll patients. However, as you know, beginning in mid-March elective procedures be to be deferred in order to preserve resources for COVID-19 patients, and to protect people from coronavirus exposure. During the last two weeks of the quarter, we saw significant decline in enrollment, as significantly fewer individuals were receiving colonoscopy and signing up for this study. While we still believe it is possible to complete the enrollments within the 24-month timeframe, we announced last November it is too soon to definitely say when the colonoscopy screenings and subsequently our enroll that will ramp up again. That said, we've been able to accelerate the on-boarding of additional new sites as a result of their increased bandwidth due to lower procedure volumes. We have also decided to expand our target number of clinical sites from 100 to 150 to compensate for potential delays in enrollment. Last weekend, we presented three poster presentation at the Digestive Disease Week Spiritual Meeting, including one post of distinction on the performance of our LUNAR 2 assay. In that presentation, we demonstrated improved specificity of our assay in a previously presented CRC profile. Specificity improved slightly from 89% to 94% when testing colonoscopy screened negative samples versus samples from samples self-identified healthy individuals. Returning to our advanced cancer business, from the beginning, one of Guardant's key differentiators has been our focus on high impact clinical studies. In early April, data was published in major cancer from a steady led by Memorial Sloan-Kettering Cancer Center, its findings demonstrated that Guardant 360 shows 89% concordance. It's been tissue and blood for identifying breast cancer patients with PIK3CA mutations. Guardant 360 also detected significantly more potential resistance alteration compared to tissue biopsy testing. These findings build upon the plasma match study results and show the importance of using a liquid biopsy test to conduct comprehensive genomic testing in metastatic breast cancer. In conclusion, I want to again thank the Guardant team for their incredible efforts to develop our COVID-19 tests while we maintain our focus on our existing business, serving cancer patient and our biopharma partners as well as executing on our LUNAR pipeline activities. We are continuing to invest in our pipeline and remain focused on areas as our long-term growth drivers for our business. With that, I will now turn the call over to Derek Bertocci for more detail on our financials. Derek?

Thank you, AmirAli. Revenue for the first quarter of 2020 totaled $67.5 million up 84% from $36.7 million in the prior year quarter. The increase was driven by significant increases in both testing volume and average selling price for ASP per test. Total precision oncology testing revenue for the first quarter was $60.2 million up 109% from $28.8 million in the prior year period. Precision oncology revenue from clinical tests in the first quarter totaled $38 million up 122% from $17.1 million for the prior year quarter. First quarter clinical precision oncology volume totaled 15,257 tests, up 60% from 9,521 tests in the prior year quarter. However, first quarter test volume was adversely impacted by the COVID-19 pandemic starting in March, resulting in no growth from the prior quarter volume of 15,270 tests. As Helmy mentioned, average daily clinical US sample volume declined steadily across the last three weeks of March, bottoming approximately 30% below the average level in the first 10 weeks of Q1 2020. Clinical US sample volume steadied at this level in the first three weeks of Q2, then picked up approximately 10% across the next two weeks of the second quarter. We believe this reflects the acute nature of care for late stage cancer patients, whereby diagnosis and treatment cannot be delayed for too long. While encouraging, there is still too much uncertainty of the impact of COVID-19 to provide a forecast for clinical volumes at this time. Clinical precision oncology ASP was $2,489 in the first quarter of 2020, up 38% from $1,800 in the prior year period, and up 21% from $2,049 in the fourth quarter of 2019. The increase in ASP was due principally to the start in March 2020, a reimbursement by Medicare for testing of non-lung cancer samples in accordance with the expanded draft LCD issued by Noridian in May of 2019. Our meadow GBA is the Medicare administrative contractor or MAC responsible for administrating Medicare's molecular diagnostic services program, or MolDX. Noridian the MAC responsible for adjudicating claims submitted to Medicare by labs located in California, such as Guardant Health, and is a participant in MolDX. The expanded draft LCD issued by Noridian for our Guardant 360 test is consistent with the expanded LCD that Palmetto GBA finalized in December 2019 and made effective in February 2020. We know that Noridian has yet to finalize their draft LCD. However, they have been making payments under it since March. Precision oncology revenue from biopharmaceutical tests in the first quarter totaled 22.3 million up 90% from $11.7 million for the prior year quarter. First quarter pharma precision oncology volume totaled 5,266 tests, up 40% from 3,762 tests in the prior year quarter. As we had forecasted, first quarter volume was lower than in the prior quarter, down 17% from Q4 2019, due mainly to the timing of customer programs. ASP was 4,230 up 36% from 3,109 in the prior year period. The increase in ASP was due to a greater proportion of such tests, being the Guardant omni test, which has a higher selling price in the Guardant 360 tests. Similar to clinical oncology testing, we are seeing indications biopharmaceutical sample volumes and precision oncology revenue may also be adversely impacted by the COVID-19 pandemic. Development services revenue in the first quarter totaled $7.3 million, down 7% from the prior year quarter. The decrease was primarily related to the timing of project related milestones for companion diagnostic development programs. Gross profit for the first quarter of 2020 was $47 million compared to a gross profit of $23.1 million in the same period of the prior year. Gross margin in the first quarter was 70% as compared to 63% during the first quarter of 2019. Gross margin improvement was primarily due to higher ASP with contribution also from production and cost efficiencies. Total operating expenses for the first quarter of 2020 were $81.9 million, a 75% increase from $46.8 million in the first quarter of 2019. R&D expenses for the first quarter of 2020 were $37 million compared to $16.3 million in the first quarter of 2019. The increase was primarily attributable to increased spend to support our LUNAR programs, including the ECLIPSE clinical trial. Our FDA submission for Guardant 360 and other research and development programs, as well as $8.5 million of expense related to in-process R&D assets expense in connection with the patent license agreement executed in March 2020. Sales and marketing expenses for the first quarter of 2020 were $25.1 million, compared to $17.8 million in the first quarter of 2019. The increase was due to increases in sales and marketing staff, plus programs to increase education and awareness about liquid biopsy. General and administrative expenses for the fourth quarter were $19.8 million compared to $12.7 million in the first quarter of 2019. This increase was primarily due to additional staff to support the growth of the company. Legal expenses, including charges related to key chain license agreement and the cost of compliance with the requirements of becoming a large accelerated public filing with the SEC. Net loss attributable to Guardant Health common stockholders was $27.7 million or $0.29 per share compared to $26.1million or $0.30 per share in the first quarter of 2019. We ended the first quarter of 2020 with $758 million in cash, cash equivalents and marketable securities. As Helmy mentioned, we are with withdrawing our financial outlook. The impact of the COVID-19 pandemic on oncologists, diagnosis and treatment of cancer patients and biopharmaceutical drug development programs will depend on many factors, including the duration of the outbreak, and the mitigation requirements affecting healthcare, delivery and society in general. While there is still too much uncertainty about the impact of COVID-19 to provide a revenue forecast at this time, the continued flow of patient samples for testing and interest in new programs from biopharmaceutical customers indicates that the need and demand for our products and services is solid. We are mindful of the times and our focus on ensuring our spending is well controlled while we meet the needs of oncologists, late stage cancer patients, our biopharmaceutical customers and our shareholders. We look forward to providing you with an updated outlook once we can reasonably estimate magnitude or duration of specific impacts on our business. At this point, I'd like to turn the call back to Helmy.

Thank you, Derek. Before closing, I wanted again thank our team of Guardant for the strength, dedication and effort they have shown, particularly over the last few months. In these unprecedented times, I have even more confidence in the value that liquid biopsy can bring to the cancer treatment paradigm. We are well prepared operationally, financially and strategically to navigate through this challenging period and we remain focused on our long-term opportunity ahead of us to transform cancer patient care. With that, we'll now open it up to questions.

[Operator Instructions] Our first question comes from the line of Doug Schenkel of Cowen. Your line is open.

I just want to ask a few on what's going on the clinical side. You obviously did a great job, providing a lot of detail there. So I just have a few follow-ups. So the first is, it seems like the trajectory you were on through much of Q1, certainly over the first 10 weeks, if that had carried through the end of the quarter? Is it right to conclude based on your prepared remarks and making some logical leads that you think total clinical volume might have been on to one and a half thousand test higher if not for the pandemic? In terms of where you're seeing pressure, I'm curious, how much of that is same store versus just an inability to open up new accounts in detail recently opened accounts. Thirdly, I am wondering if there is any signs that this could actually, you never wish for a pandemic, but you just wonder if the value proposition associated with a blood based test becomes that much more clear to clinicians. So maybe this actually leads to a share acceleration over time. And then lastly on ASPs, given that you only started getting paid on volume for solid tumors, other than non-small cell lung cancer in March, I'm wondering if we should be expecting that ASP to move up sequentially. Thank you.

You have an array of questions there, Doug. Let me see if I can remember them all. I think the first one, we're not really breaking that out in terms of what it would be, but I don't think you're that far off in terms of the - in terms of your estimate there. I think in terms of same store sales or new additions, I think surprisingly, we are seeing new additions, even new addition ads even in this environment. But to your point, this is an uncertain environment. Customers want to minimize risk across every decision they make. And the fact that there thousands to thousand oncologists that have used our tests, that are familiar with the quality and the service we can provide and our technology and what it offers is an advantage for us. We're able to strengthen and deepen our relationships with those customers during this time, and that's something we've been able to pursue. I think that being said, the backdrops obviously very challenging in many of these oncology offices. The pendulum, at least in April and the late part of March swung towards fear of COVID, over necessarily matching patients to the most effective therapy as quickly as possible. That said, we do believe this is a unique opportunity, despite the tragedy that's around us, for liquid biopsy. The fact that liquid biopsy does cut through a lot of the logistical challenges of getting access to tissue, needing an army of medical professionals to determine what may be the best molecular profile of that patient and the best associated treatment. And so the fact that we have mobile phlebotomy, that it's a simple blood draw to get access to that information, even I think accentuates the advantages that liquid can offer even more so. So we do see that there is a silver lining there in terms of liquid biopsy being able to uniquely position itself, and Guardant 360 more specifically, in the workflow of these oncology offices that that need a solution like this to protect their patients from further risk of exposure. The last one was maybe ASP? I guess, Derek, can you take that?

So relative to your question on ASP, this obviously was a quarter where we saw a significant jump by the start of reimbursement for non-lung samples. So we would expect there won't be another big step function like this in Medicare. We would expect as we saw when the Medicare lung reimbursement started, it was a slow, gradual process working through with private payers to get them to take on that reimbursement. We would expect the same thing with private payers, moving them from lung to pan-cancer reimbursement, but that will be a slower more steady process over several quarters.

Our next question comes from the line of Puneet Souda of Leerink. Your line is open.

Thanks Helmy and congrats on a strong quarter in this disruption, and also welcome to John to the team. So first question I have is on the use of mobile phlebotomy. I mean I appreciate the details here that you are seeing in the last couple of weeks. Could you quantify the contribution that you're seeing from mobile phlebotomy in the quarter? And how effective do you think it will be, you know, as we go through this May and June sort of time period? And how permanent do you think mobile phlebotomy becomes as a fixture of G360 going forward? We have obviously seen significant increase in telehealth among oncology. So wondering if mobile phlebotomy is something that you continue to use, utilize higher as you go forward among these patient groups?

Yes, great question Puneet. Mobile phlebotomy is something that we've had for many years. But we've certainly seen acceleration of its use. It really is dependent on in which territory, the density of a territory, but some areas we're seeing multi-fold increase in terms of its use. But I would say that we look at the suite of services more holistically. Mobile phlebotomy is just one aspect, and one service that we can provide that can give the physician and patient comfort in terms of reliably and easily getting access to this kind of information. I would say the financial assistance program for COVID affected patients is another one that we've seen a lot of benefit from. And I think the third one is really moving to digital and virtual channels, really leveraging those. We're seeing physicians for the first time in oncology leverage videoconference, Zoom meetings and so on to be able to consult with their patients, to consult with our account representative then our medical affairs staff. And we don't think this will go away completely, even if we're past COVID. We think this is going to accelerate the digital revolution in the oncology space, and we're well equipped to be able to enter that area. We moved really quickly, in terms of mobilizing all of these services. And so it's something that we're prepared to maintain for the foreseeable future as this space and the field continues to adapt to these new technologies.

Okay, that's helpful.

And if I may add one more point, this mobile phlebotomy, we are seeing a lot of benefit. I also would like to highlight, that putting mobile phlebotomy aside when you look at just the logistics of blood collection, even still in a centralized fashion in the clinic, and you're conquer that logistics versus logistics of tissue sample retrieval from biobank or pathology lab. Still, you're seeing some significant advantages, even in blood draws in-clinic still, versus release of samples from other departments or other locations, which were impacted during these times.

Thanks for the detail. That's very helpful. So the next question is on trials. If you could, I appreciate you're seeing a clinical trial impact, so I just wanted to get a view on how both on the omni and G360 are levered to therapeutics clinical trials? Where the assay might be necessary versus other trials where it might be exploratory currently? Could you give us a sense of how that could play out, and what are you hearing from the biopharma customers both large and small? And on the LUNAR 2 trial, I appreciate you giving details around the 150 clinical trial site increases. But if you could provide any sense of, sort of, a recovery that you were expecting here. I suppose, so that you can do this trial without having colonoscopies out there, but with more trials, what's your expectation in terms of the timeline, sort of, shift in at least in the near term?

Yeah, sure. So regarding our using of our assays and our assets in our partners' clinical trials, we cannot talk about the specific trials, obviously, by general are seeing actually bunch of studies that they are continuing relatively at full speed. Some states that have been impacted maybe more than other ones. So in the segments that in our products has been used in prospective screening trials, we've seen some kind of marginal impact in those sample volume. Retrospective, this is different than you know - we have to see, like what's going to happen as a result of pandemic in retrospective samples conversations. You know the timeline for those conversations are longer, so it's too early to assess if any impact is going to get experienced under retrospective side or not. As we mentioned in the opening remarks, that development services are moving full speed. We haven't experienced any kind of slowdown in conversations, that have been strong. Regarding LUNAR 2 trial, there is some aspects of it which we have to just see what's going to happen within the next couple of months in terms of ramping up ECLIPSE trial. What we sell as a significant decline in the last part of March. The amount of decline that we saw and some of the pushbacks that we have in our timelines in ECLIPSE trial program, we see so a good possibility that we are going to hit the 24 months. But there is some aspects of it that we have to see how quickly colonoscopy procedures and things trials in those sites would ramp up. And on the other side, since those sites out time, they've been more engaged with us. We have managed to increase number of sites actually significantly during last quarter. Even the sites, actually, they were not open to work with us for our ECLIPSE trial, now in fact, there are becoming open to work with us and being included in our ECLIPSE trial. So, this is actually pretty exciting to in for the future of LUNAR 2, but in terms of the exact ramp up in ECLIPSE, I think we have to wait still few more weeks and better assessment then.

Okay, I appreciate that. And the last one if I can squeeze on the FDA, any updates there for G360? Or any feedback or questions from FDA? and I appreciate that. Look, in during these times FDA diagnostic division is likely busy with COVID, but I'm just wondering if there are any updates on that front. Thank you.

Actually, we are really happy with communication and back and forth that we have with CDRH. In fact, I don't know if we've noticed any kind of slowdown from CDRH side or even our side when responding back to them. So the back and forth has been strong. Conversations have been going full speed, and whenever actually they raise any question, our team has been able to respond to them very quickly. So we are in the process of the review, and still we have to wait to see more progress to see what we are going to see that. But I'm very happy with the progress that we've seen so far and average and contribution by the agency during these difficult times. I don't believe we've notice any slowdown in our activities with the branch we are in touch with.

Your next question comes from the line of Tycho Peterson of JP Morgan. Your line is open.

This is Julia on for Tycho. Thanks for taking the question. Helmy mentioned about the site expansions or alluded to, just wondering how much does that add to your OpEx for the year?

Site expansion. So, since our trial enrollment have actually slow down. So there's been some OpEx saving there. So we don't believe actually addition of these sites would have a material impact on the previously quoted OpEx that we put for the whole ECLIPSE trial that is area within 70 to 100 million. So we believe within that range we can execute on ECLIPSE with additional sites that we are adding to the program.

Got it. And then on the rationale for developing your own COVID test, just curious what inning are you guys currently in, in terms of the timeline? And why do you believe that Guardant is well positioned to participate in this market given the number of players who already out there and ramping up capacity?

So maybe in terms of timelines. We are in the feasibility phase, we are doing something differentiated relative to the vast majority of the tests which are out there. We want to be additive instead of competing with some shared resources which everybody is trying to add into. In terms of timeline, we are talking about like order of weeks, we are not talking about months. It's a program that's making progress very quickly and I think we should be able to have some updates about that in near future. In terms of why Guardant - to be honest with you, I hoped we did not need to get into this thing. Our battle with COVID-19 started earlier at Guardant, as Helmy mentioned during remarks. We are testing all of our employees now for several weeks in a surveillance setting and we are monitoring what was happening in the field. And few of us, we couldn't actually really sleep well and be at ease with what was happening in terms of lack of testing that was happening. And we felt social responsibility that if we can contribute, we have to try to contribute versus trying to be opportunistic during this time of pandemic. So we felt our responsibility, and now we are doing our best to see if we can contribute in solving this problem. And we are putting our technical expertise on the innovation side, are stable and high throughput, highly efficient clinical testing. And there are not many stories that players are doing new technology, development on the other side, they are building very high throughputs operational capacity. And I think we are pretty good there. So we are putting our expertise in line to see if we can contribute.

Got it. And lastly, do you guys have an update on when you're expecting to submit OMNI for FDA approval?

Well, OMNI we haven't provided any timeline for PMA submission. But we are making actually pretty good progress on the IVD developments of our device with omni-panel, but we haven't provided any timeline or a submission or applicable as of now.

Our next question comes from the line of Derik De Bruin from Bank of America. Your line is open.

So I just want to follow up on the COVID questions, but I want to take a different approach. So I'm curious, you're using saliva. What's the limited detection in terms of viral particles in the saliva? I guess, how soon after infection do you start to see shedding into the saliva? How does it compare relative to a blood sample in terms of where you are in that window of opportunity to detect?

Yes, sure. So in general, there is some good evidence based on literature using different kind of assays when they had some experience saliva and nasal swabs. And if you do saliva collection the right way and you know you transport it properly, in fact you can get very good clinical sensitivity. And even, now there are some ERA-approved devices that are saliva based. In terms of limit of detection, I think we are really in visibility mode, but there is nothing in our assay that doesn't give us confidence that our assay should have worse limit of detection than other RT-PCR based assays. So that stack looks pretty solid, but you know we are in the visibility, we have to see what's happening in the matter of the next few days or weeks. The major contribution that hopefully we're going to have for the field is high-throughput or ultra-high throughput testing of fleet. So, we'll see.

I would just maybe add some color there. A lot of what we're doing is really kind of to be orthogonal to the existing supply chain and find a methodology that works that could be scaled up aggressively. If there is a need, and I want to reiterate, as soon as there is not a need, Guardant is okay getting out of the COVID field.

So I guess those lines, and you mentioned the throughput that was where my next question is. Are you doing a NovaSeq approach on this and so we're getting a question of, like what's the, - how do you look at this, sort of like the cost of goods on s test like that? I'm just be curious about your using then sort of the next-gen sequencing technologies on how you - what is the economics around doing this? How many do you need to load? What do you need to do? I'm sort of curious on how it all works?

So actually as a platform, the technology sector you're using, we are leveraging, a lot of expertise we have internally stacked that we built for G360 for its cancer detection. So as a result, it's NGS-based. It's going to be very cheap, so still we are in the visibility phase. But it's not that all NGS-based are going to be expensive. And in fact I'm pretty confident actually this could be a low cost test in terms of the cost that we are going to have at this scale. At this scale we are talking about. So again hopefully we can go through this visibility phase and maybe in a few weeks we will have more updates for you.

Great on the, - on the recent data release at the DDW, could you break that out in terms of different stages, early, late, sort of like where you are in pre-cancerous? And just a little bit more color on how the sensitivity sort of specifically works across the different sub-types?

Yes, sure. For clarification actually, the disease cohort was like the CRC cohort was the same on that actually we showed before in our previous reports. The differentiation in this, and you know, it's like whose contributions slight improvement, is instead of looking at blood samples from individuals or declaring they are healthy, right? We look at it test cohort of patients who have gone through colonoscopy screening, and they colonoscopy screened negative patients. So there is confirmation they don't have various stage or any stage CRC, and they don't have advanced, as you know. And when you look at that cohort as the headset for your specificity, we saw an increased specificity from 89% to 94%, or on the other side non-specificity reduced from 11% to 6% so that's basically the slight improvement that we reported. This cohort remains the same as what we had before in our previous data disclosures.

Your next question comes from the line of Patrick Donnelly of Citi. Your line is open.

Maybe just one on the operating spend, sort of understand some of the clinical trial spend will get pushed out a little bit here? Are you making any other changes in terms of the planned spend for this year? Just given some pause on some of the volumes. Any changes to the original outlook there?

Sure. So, Patrick we are looking at this interesting period. Obviously COVID-19, and it's causing some disruption to our revenues, but we are looking at this also as an opportunity to take our substantial and strong balance sheet and continue to pursue the programs that we see driving future revenue growth. So we are not pulling back on those programs. What we are doing is looking at all of our expenses and trying to make sure there are areas where we can pull back, or there are potential savings like travel statements better. We're making sure that we are capturing those savings. But we think that we should not take off our effort to pursue the programs and will provide long-term growth for the company and reward both patients, doctors and shareholders.

Okay. And then maybe on the oncology volumes, certainly encouraging to hear the 10% uptick in the last few weeks. Can you maybe just talk about, has that the broad based geographically? I know you guys usually a pretty good data on that front. And then any conversations with customers in terms of the ordering patterns on what they're seeing? Are people coming back after, again, kind of avoiding office visits for a little while? What's the right way to think about that being sustainable or maybe even being higher?

Yeah, that's a good question. So we're not really seeing any, I would, say materials geographic differences. And we're really seeing it's fairly broad in terms of the comeback or the uptake. I would say that this has been reported by multiple data sources that just the physical number of office visits, the number of patients that are coming in, the number of new diagnoses in cancer has come down relatively significantly in 25% to 35% range depending which data you look at. And so obviously that is having an effect. And just in terms of patient flow, physician offices clearly struggling to some extent, if they're not getting the same patient flow, then I'm seeing the same kind of patients coming in. And that's something that clearly we'll have to see how that plays out. But we're hopeful that as people get used to this new normal, that as the pendulum swings from the fear of COVID to the certainty of dying from cancer, that things will come back at some point. It's obviously hard to estimate exactly what that recovery looks like. Some of that is dependent on many factors. The second that happens in the winter, but we do know that cancer is going to remain and remain a significant problem for many of these patients. And we're going to have to figure out what is the right approach to deal swiftly and aggressively with the care of these patients. And that's something that I really commend the team here, and obviously commend all the health care professionals in the front lines who are adapting quickly to this new environment.

Right, that's helpful and then just a quick one on the Noridian side. Any update in terms of LCD time? I know, obviously, you called out, they've been making payments, or payments been collected since March. But maybe just an update on expectations there. Thank you.

Yeah, there's really no update at this time there. It's really up to Noridian in terms of when they will finalize that policy. But as we said, we've been receiving payments regularly from Noridian since March.

Your next question comes from the line of David Westenberg Guggenheim. Your line is open.

I just actually want to follow up on the geographic question. So a lot of major cancer centers do tend to be in major cities. And if we do see kind of a phased reopening, I'm just kind of curious if you've seen any differences in volumes between the community setting in the academic setting? And should that matter, if we say, if we see COVID persist or we see some sort of phased opening with maybe non-urban centers, opening up before urban centers?

Yeah, that's a great question. We are seeing differences between those two categories. We saw that the community wasn't as affected in terms of the dip as academic. Academic really took a much bigger hit. We believe that's because they tend to be more generalist, and they are putting a lot of their resources on onto battling COVID, versus some of these community sites are insulated from that. We're still seeing that trend holding to some extent with community really not as affected in buffering kind of this low quite, quite a bit better than the academic centers. So I agree with that sentiment that you stated.

And can I kind of follow-up with that? Have you given any data in the past between where your volumes are in terms of - I think you kind of mentioned that community is actually an important setting just because the personnel isn't in place to necessarily do some of the surgeries that require tissue. So I don't know if you have any color on those differences. I mean, on that percent or if you can't, maybe something qualitative.

Yeah so typically the numbers that are out there, that 85% of patients are treated in the community setting, which is why that's the goal as we penetrate deeper into physician workflows, is to get to higher and higher dosing on the community side. Historically, we've trended towards about 60% community, 40% academic. But in recent weeks, it's been even higher than that.

Perfect. No, thank you. That's very helpful. And then just I'll just do one short one. Can you talk about maybe the capacity that your biopharma partners are running at in terms of working on oncology? Just with potential shift in focus and resources in pharma to maybe - devoted to COVID?

There is a, maybe only a handful of companies are deeply in the COVID space. I think historically a lot of the shifts in spending have maybe hit sales and marketing. They've hit R&D, but I would say it's probably too early to say given - these reprioritization of portfolios take some time at many of these companies. So I think it's too early to comment on that.

Your next question comes from the line of Max Masucci of Canaccord. Your line is open.

So first on the COVID-19 tests. Would you be looking to go after, sort of, a large scale testing in an asymptomatic population more of a proactive versus a reactive approach? And will the development or the processing of the COVID test be done solely by Guardant? Could we potentially see some industry group effort or partnerships?

So we are doing this kind of testing at Guardant for our own employees for weeks now. Vast majority of cases are symptomatic people. So capacity per meeting, I think this is a right way of doing it, like testing the symptomatic patients. Having said that, I think there are some even need the symptomatic fronts in the essential businesses, and people in the front line of this disease that they need to get prior to that attention. And there are some unmet needs there. But hopefully when the capacity gets filled up and maybe we can contribute to some extent. Then I think hopefully we reached that day that aysomptomatic patients can get screened. That's our belief and that's our mission, even in oncology space, find it early and deliver a result, signs prevention earlier. That's the way to improve outcomes, so same thing in this space. In terms of employers, there are actually a bunch of companies who are interested --companies on the essential business side. They have employees on-site now, or do you want to employees back on-site and they want to make sure they do that as safe as they can. So there are a bunch of employers who are thinking about what should be their strategies to increase safety in their work environment. I think that tells us there are a lot of opportunities for partnerships here.

Great, that's helpful. And then maybe one more. Are you seeing, or do you expect to see some elevated interest and the use of LUNAR 1 in the adjuvant setting during COVID? Just to inform better decisions around eliminating the number of immune-suppressed patients. And then are there any new opportunities that might be popping up as a result of this?

So, currently we don't have LUNAR 1 clinical tests that we basically gave broad access to oncologists. We have a clinical raise in our LUNAR 1 product, which is used in clinical trial or some early investigation by select KOLS. So as a result, I don't think we're in a position to comment what would be the future of this kind of clinical MRD setting in this pandemic. Having said that, I think in general, blood test liquid biopsy tests are removing bunch of barriers, and could open up new opportunities in providing better care to patients across the whole spectrum of care.

Okay, well thank you again and hope everyone to stay healthy safe in this challenging time.

Thank you.

Ladies and gentlemen, this concludes today's conference call. You may now disconnect.