Guardant Health (NASDAQ:GH) Q1 2020 Earnings Call

0:01 Ladies and gentlemen, thank you for standing by and welcome to the Garvant Health Q1 2020 earnings call.

0:08 At this time, all participants' lines are in a listen-only mode. After the speaker's presentation, there will be a question-and-answer session. To ask a question during the session, you will need to press star 1 on your telephone. Please be advised that today's conference is being recorded. If you require any further assistance, please press star 0. I will now turn the call over to our first speaker, Carrie Mendeville, Investor Relations. Please go ahead.

0:36 Thank you. Earlier today, Garden 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 gardenhealth.com. Before we begin, I'd like to remind you that management will make statements during this call that are forward-looking statements These statements involve material risks and uncertainties that could cause actual results or events to materially differ from those anticipated. Additional information regarding these risks and uncertainties appears in the section entitled Forward Looking Statements in the Press Release Garden Issue 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.

1:25 and other filings with the Securities and Exchange Commission. Except as required by law, GARDEN disclaims any intention or obligation to update or revise any financial projections or forward-looking statements, 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 7, 2020. With that, I'll turn the call over to Helmy Eltoukhy, GARDEN's co-founder and chief executive

1:51 officer. Helmy? Thanks, Carrie. Good afternoon and thank you for joining our first quarter 2020 earnings call. Joining me today is Amir Ali Talasaz, our president and co-founder, and Derek Bertacci, 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 than 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 efforts to care for both COVID and non-COVID patients in these difficult times. I'm also very proud of the Garten team for the tremendous dedication and drive they have shown over the past few months, quickly adapting to this new environment.

2:42 Amidst this pandemic, cancer patients, particularly those in late stages of the disease, still need access to information to guide treatment decisions. The GARDEN 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 a half years ago, an 86-year-old woman was diagnosed with stage four non-small cell lung cancer. Genomic profiling was completed, and the patient was found to have an EGFR exon 19 deletion. 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 will develop a T790M resistance mutation, which fortunately is targetable.

3:38 In order to determine her next line of therapy, her oncologist needed a genomic reassessment of her tumor. However, given the COVID-19 pandemic, and risk of her exposure, he was reluctant to bring her into the office for testing. Using GARDEN's mobile phlebotomy services, he was able to have blood drawn in the safety of her home and tested using GARDEN360, which identified a T790M 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.

4:28 Moving on to our business, we ended the first quarter with a revenue of $67.5 million, growing about 84% over the first quarter of 2019. During the quarter, we continued to see strong demand for our commercial products and began receiving payments for Garden360 from our local Medicare administrative contractor related to the pan-cancer LCD for non-lung tests. While our business overall was strong in the first quarter, we did start to see an impact from the spread 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.

5:20 Even with the impact of COVID-19, clinical volumes for Garden360 grew 60% to 15,257 clinical tests compared to the first quarter of 2019. And biopharmaceutical volumes grew 40% to 5,266 tests. Exiting the first quarter, U.S. 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.

6:08 Amir Ali will give further detail on the impacts 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 Garden to conquer cancer with data. Amidst 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 the 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.

7:00 Starting with our internal response to the pandemic, our employees' health and safety remain our top priority. Garden has been designated an essential business that can continue necessary operations during the pandemic. In early March, we promptly instituted protocols to let two-thirds of our employees 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 offering voluntary repeat COVID-19 testing for our employees, which we view as an important step to ensuring their health and safety in our workplace.

7:51 We also believe that this type of active surveillance testing, capacity permitting, is a model that if widely adopted would be of 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 U.S., there are only a few hundred thousand tests performed per day, while many estimate a need for five to ten 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.

8:42 This exploration includes a 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 Garten 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 the 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.

9:29 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 spread, we were able to scale up this program and offer home blood draws for Garden360, as demonstrated in the patient story I shared at the top of the call, to protect vulnerable patients from possible exposure to COVID-19 in 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.

10:29 Given the challenges of obtaining a biopsy or monitoring patient progression, We have seen high levels of engagement with our teams due to the unique value proposition of Garden360 in overcoming the many barriers that this pandemic has either exacerbated or created. Earlier this week, we launched the Clear Your 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 patients. This campaign calls 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.

11:19 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 GARDEN 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 am 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 Garden's new general counsel. I'm excited to have John as part of the Garden team and I'm confident in his ability to lead our legal team as we continue to scale our business.

12:15 I also want to thank Michael Wiley for his many contributions at Garden. 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 Amir Ali for more detail on our efforts on combating COVID-19, our biopharma partnerships and our lunar program.

12:42 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 feasibility of developing a high-throughput diagnostic test for COVID-19. While we were offering third-party surveillance testing to our own employees, we realized there is still a major shortfall with this state of testing. We believe there will be significant testing needs around the world for the foreseeable future related to COVID-19. and felt a social responsibility to leverage our expertise to contribute to this need.

13:30 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 a turnaround time of 24 to 36 hours. We plan to offer this assay initially in the state of California to essential workers in the frontline setting and underserved communities, as well as to employers for surveillance testing of employees. Moving to our core business and starting with biopharma.

14:18 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 service businesses. 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.

15:12 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. In 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 treatment in stage 3 colon cancer patients based on the detection of ctDNA post-surgery.

16:10 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 a half months of the quarter and now have more than 100 sites onboarded to enroll patients. However, as you know, beginning in mid-March, elective procedures began 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.

17:07 While we still believe it is possible to complete enrollment within the 24-month timeframe we announced last November, it is too soon to definitely say when the colonoscopy screenings and subsequently our enrollment will ramp up again. That said, we've been able to accelerate the onboarding 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's virtual meeting, including one poster 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 cohort.

18:12 Specificity improved slightly from 89% to 94% when testing colonoscopy screened negative samples versus samples from self-identified healthy individuals. Returning to our advanced cancer business, from the beginning one of GARDEN's key differentiators has been our focus on high-impact clinical studies. In early April, data was published in Nature Cancer from a study led by Memorial Sloan Kettering Cancer Center. Its findings demonstrated that GARDEN360 showed 89% concordance between tissue and blood for identifying breast cancer patients with PIK3CA mutations.

19:03 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 Gartner team for their incredible efforts to develop our COVID-19 test while we maintain our focus on our existing business serving cancer patients 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 that are long-term growth drivers for our business.

19:55 With that, I will now turn the call over to Derek Bertacci, for more detail on our financials. Derek? Thank you, AmirAli.

20:05 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.

20:54 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.

21:41 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 about 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.

22:37 The increase in ASP was due principally to the start in March 2020 of reimbursement by Medicare for testing of non-lung cancer samples in accordance with the expanded draft LCD issued by Meridian in May of 2019. Palmetto GBA is the Medicare Administrative Contractor, or MAC, responsible for administrating Medicare's Molecular Diagnostic Services Program, or MOL-DX. Noridian is the MAC responsible for adjudicating claims submitted to Medicare by labs located in California, such as Garden Health, and is a participant in MOL-DX.

23:23 The expanded draft LCD issued by Neridian for our Garden360 test is consistent with the expanded LCD that Palmetto GBA finalized in December 2019 and made effective in February 2020. We note that Neridian 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 pharmacoprecision oncology volume totaled 5,266 tests, up 40% from 3,762 tests in the prior year quarter.

24:20 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 Gardens Omni test, which has a higher selling price than the GARDEN360 test. Similar to clinical oncology testing, we are seeing indications that biopharmaceutical sample volumes and precision oncology revenue may also be adversely impacted by the COVID-19 pandemic.

25:10 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 cost efficiencies.

26:03 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 Garden 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 a patent license agreement executed in March 2020.

26:59 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 the key gene license agreement, and the cost of compliance with the requirements of becoming a large accelerated public filer with the SEC.

27:54 Net loss tributable to Garden Health common stockholders was 27.7 million or 29 cents per share compared to 26.1 million or 30 cents 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 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 Thank you.

28:45 Thank you. Thank you. 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 the magnitude or duration of specific impacts on our business.

29:36 At this point, I'd like to turn the call back to Helmy.

29:42 Thank you, Derek. Before closing, I want to again thank our team at Garten 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. As a reminder, to ask a question, you will need to press star 1 on your telephone keypad.

30:28 To withdraw your question, please press the pound key. Please stand by while we compile the Q&A roster. Our first question comes from the line of Doug Shanko of Cohen. Your line is open.

30:46 Hey, good afternoon, guys, and thank you for taking my questions. I just want to ask a few on what's going on 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, you know, 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 leaps that you think total clinical volume might have been 1 to 1,500 tests 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 and detail recently opened accounts.

31:34 Thirdly, I'm wondering if there's any signs that Thank you for joining us. 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.

32:10 Well, the battery of questions, let me see if I can remember them all. You know, I think the first one, you know, 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, you know, in terms of your estimate there. You know, I think in terms of same-store sales or new additions, I think surprisingly we are seeing new additions, even new physician ads, even in this environment. But, you know, to your point, this is an uncertain environment. Customers want to minimize risk across every decision they make. And the fact that, you know, there are thousands, you know, 7,000 to 8,000 oncologists that have used our tests that are familiar with the quality and the service we can provide in 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 it's something we've been able to pursue.

33:11 I think that being said, the backdrop's 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. Thank you very much. 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 Garden360 more specifically in the workflow of these oncology offices that need a solution like this to protect their patients from further risk of exposure.

34:42 I guess the last one was ASP, maybe Derek, do you want to take that?

34:45 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, there 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 a pan-cancer reimbursement. But that will be a slower, more steady process over several quarters.

35:34 Okay, thanks again.

35:36 Thank you. Our next question comes from the line of Puneet Sudha, Fleering. Your line is open.

35:46 Hi, great. Thanks, Helmy, and congrats on a strong quarter in this disruption. And also welcome to John Saia to the team. So first question I have is on the use of mobile phlebotomy. I mean, I appreciate the details here that you're seeing in the last couple of weeks. Could you quantify the contribution that you're seeing for mobile phlebotomy in the quarter? and how effective do you think it will be 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 a significant increase in telehealth among oncology, so wondering if mobile phlebotomy is something that you continue to utilize Thank you very much.

37:09 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 video conference, Zoom meetings and so on to be able to consult with their patients, to consult with our account representatives and 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 a digital revolution in the oncology space.

38:14 And we're well equipped to be able to enter that era. We move 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.

38:37 Okay, that's helpful. If I add one more point.

38:39 Yes, please.

38:41 Yes, which mobile phlebotomy, definitely you're seeing a lot of benefit. I also would like to highlight that even 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 compare that logistics versus logistics of tissue sample retrieval from biobank or pathology lab, So you're seeing some significant advantages given in blood draws in clinics still versus release of samples from other departments or other locations which could be impacted during these times.

39:20 Thanks for the detail. That's very helpful. So the next question is on trials. I appreciate you're seeing a clinical trial impact, but just wanted to get a view on on how both 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, you know, 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, you know, sort of a recovery that you are expecting here. I suppose so that you can't do this trial without having colonoscopies out there, but with more trials, what's your expectation in terms of the timeline, you know, sort of shift at least in the near term?

40:23 Amir Ali Talasaz.

40:25 Yeah, sure. Yeah, so regarding our using of our assays and our assets in our partners' clinical trials, we cannot talk about the specific trials, obviously. But in general, we are seeing actually a bunch of studies that they are continuing relatively at full speed, some studies that have been impacted maybe more than other ones. In the segments that in our products have been used in prospective screening trials, we've seen some kind of marginal impact in those kind of sample volume. Retrospective is different. We have to see what's going to happen as a result of pandemic in retrospective sample conversation.

41:16 The timeline for those conversations are longer, so it's still too early to assess if any impact is going to get experienced on the retrospective side or not. As we mentioned in the opening remarks, the development services are moving full speed. We haven't experienced any kind of slowdown in conversations, and pipelines 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 and a couple months in terms of ramping up Eclipse trial. What we saw was a significant decline in the last part of March. The amount of decline that we saw and some of the cushions that we have in our timelines in Eclipse trial program, we see still a good possibility that we are going to hit the 24 months, but there is some aspect and all those teachers and doing trials in those sites would ramp up.

42:17 On the other side, since those sites have 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, they are even becoming open to talk with us and being included in our Eclipse trial. Thank you. Actually, we are very happy with Communication and back and forth that we have with CDRH.

43:21 In fact, I don't believe we've noticed any kind of slowdown from CDRH side or even our side when we're responding back to them. So the back and forth has been strong. The conversations have been going full speed. And whenever actually they raise any kind of 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... Great, thank you. Your next question comes from the line of Tycho Peterson of JP Market.

44:17 Your line is open.

44:19 Hi, this is Julia, all for Tycho. Thanks for taking a question. So Helmy, you mentioned about the site expansion for Looter 2. Just wondering how much does that add to your OPEX for the year?

44:31 We're all in to it. Site expansion. So, you know, since our trial enrollment actually slowed down, so there's been some OPEX saving there. So we don't believe actually additional of these sites would have a material impact on the previously quoted OPEX that we put for the whole Eclipse trial that is going to be 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.

45:06 Got it. And then on the rationale for developing your own COVID test, just curious, what innings are you guys currently in in terms of the timeline? And, you know, why do you believe that Garden is, you know, well positioned to participate in this market, given, you know, the number of players who are already out there and ramping up capacity?

45:33 So maybe in terms of timelines, we are in the feasibility phase. We are doing something differentiated, at least relative to the vast majority of the tests which are out there, because we want to be additive instead of going and computing with some shared resources which everybody's trying to tap into. But in terms of timeline, we are talking about an order of weeks. We are not talking about months. This is 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 Garden, to be honest with you, I hope we did not need to get into this thing. Our battle with COVID-19 started early at Garden. 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 a 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 really trying to be opportunistic in this time of pandemic.

46:53 So we felt the 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 on the table and, you know, high throughput, highly efficient clinical testing. And, you know, there are not many stories that players are doing new technology development. On the other side, they are building very high throughput operational capacity. And I think we are pretty good there. So we are putting our expertise in line to see if we can contribute.

47:29 Got it. And lastly, do you guys have an update on when you're expecting to submit OMNI for FDA approval?

47:39 For OMNI, we haven't provided any timeline for our PMA submission, but we are making actually pretty good progress on the IVD development of our device with OMNI panel, but we haven't provided any timeline for submission or approval as of right now.

47:59 Okay, thank you.

48:02 Thank you. Our next question comes from the line of Derek DeBruin from Bank of America. Your line is open.

48:13 Hello, good afternoon. 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 particle in the saliva. I guess how soon after infection do you start to see shedding into the saliva? You know, how does it compare relative to a blood sample in terms of where you are in that window of opportunity to detect?

48:49 Yeah sure so you know actually now there is some good evidence based on literature using different kind of assays when they were heads of experiments between saliva and nasal swab and if you do saliva collection in a right way and you know you transport it properly in fact you can get very good clinical sensitivities and even now there are some EUA approved devices as you may know which are saliva based. In terms of limit of detection I think we are really in the feasibility mode but There is nothing in our assay that doesn't give us confidence that our assay should have worse limits of detection than other RT-PCR-based assays. So, you know, the stack looks pretty solid. But, you know, we are in the feasibility. We have to see what's going to happen in a matter of next few days or weeks.

49:40 The major contribution that hopefully we are going to have for the field is high-throughput or ultra-high-throughput testing, hopefully. So, we'll see. I was just going to add some color there.

49:51 A lot of what we're doing is really trying to be orthogonal to the existing supply chain and find a methodology and workflow that could be scaled up aggressively if there's a need. And I want to reiterate that as soon as there's not a need, gardens is okay getting out of the COVID testing field.

50:11 Yeah. So I guess along those lines, and you mentioned the throughput, that was sort of my next question is Are you doing a NovaSeq approach on this? It sort of gets into the question of how do you look at the cost of goods on a test like that. I'm just sort of curious about using the next-gen sequencing technologies on how you – what are 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.

50:44 So actually, the platform, the technology stack we are using, we are leveraging a lot of expertise we have internally stacked that we built for 360. And in fact, our donors were the cancer detection. So as a result, it's NGS-based. And it's going to be very cheap. So still, again, we are in the feasibility phase. But it's not that all NGS-based tests are going to be expensive. 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 we are talking about. So again, hopefully we can't go through this visibility phase and maybe in a few weeks we would have more updates for you guys.

51:36 Great. On the recent data released at the DDW, Could you break that out in terms of, you know, different stages, you know, early, late, sort of like where you are in precancerous and just sort of a little bit more color on how the sensitivity sort of works across the different subtypes?

52:03 Yeah, sure. For clarification, actually, the disease cohort was like the CRC cohort was the same one that actually we showed before. in our previous reports. The differentiation in this, and you know, it's like, whose contribution, slight improvement, is instead of looking at blood samples from individuals for declaring they are healthy, right, we look at the test cohort of patients who have gone through colonoscopy screening and their colonoscopy screened negatively. So there's confirmation they don't have parity state or any state CRC, and they don't have advanced adenomas. And when you look at that cohort as the test set for your specificity, we saw increased specificity from 89% to 94%, or on the other side, nonspecificity reduced from 11% to 6%.

53:05 That's basically the spike improvement that we reported. The disease cohort remained the same as what we had before in our previous data disclosures.

53:18 Got it. Thank you.

53:22 Thanks. Your next question comes from the line of Patrick Don Lee of Citi. Your line is open.

53:31 Great, thanks, guys. Maybe just one on the operating spend. I certainly 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?

53:51 Sure. So, Patrick, we're looking at this as an interesting time. Obviously COVID-19 is causing some disruption to our revenue, 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 as 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 if there are areas where we can hold back or there are potential savings like travel savings that 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 that will provide the long-term growth for the company and reward both patients, doctors, and shareholders.

54:59 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 been broad-based geographically? I know you guys usually have 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 and maybe even going higher?

55:29 Yeah, that's a good question. So we're not really seeing any, I would say, material geographic differences. We're really seeing it's fairly broad in terms of the comeback or the uptick. I would say that, you know, this has been reported by, I think, multiple data sources that just the physical number of office visits, the number of patients that are coming in, the number of new diagnoses have come down, you know, relatively significantly in the 25 to 35 percent range, depending which data you look at. And so obviously that is having an effect in just terms of patient flow.

56:15 You know, physician offices clearly are struggling to some extent. You know, if they're not getting the same patient flow, they're not 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 it is dependent on many factors, the second peak, the second wave, what happens in the winter. But we do know that cancer is going to remain and it's going to remain a significant problem for many of these patients.

57:08 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 healthcare professionals on the front lines

57:28 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 have been collected since March, but maybe just an update on expectations there. Thank you.

57:43 Yeah, there's really no update at this time there. It's really up to Noridian in terms of when they'll finalize that policy. But as we said, we've been receiving payments. regularly from Noribian since March.

58:01 Okay. Thanks, Ali. Your next question comes from the line of David Westenberg of Guggenheim. Your line is open.

58:13 Hi. Thanks for taking my question. 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 and the academic setting. And should that matter if we see COVID persist or we see some sort of phased opening with maybe non-urban centers opening up before urban centers?

58:46 Yeah, that's a great question. We are seeing differences between those two. We saw that 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're putting a lot of their resources onto battling COVID versus some of these community sites were more insulated from that. We're still seeing that trend holding to some extent with community really Not as affected and buffering this blow quite a bit better than the academic centers. I agree with that sentiment that you stated.

59:35 Can I follow up with that? Have you given any data in the past between where your volumes are in terms of... I think you've 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, you know, if you can't, maybe some qualitative.

1:00:01 Yeah, so typically the numbers that are out there are that 80 to 85 percent of patients are treated in the community setting, which is why, you know, that's the goal as we penetrate deeper into physician workflows is to get to higher and higher indexing 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.

1:00:32 Perfect. Thank you. That's very helpful. 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?

1:00:54 There's maybe only a handful of companies that are deeply in the COVID space. I think historically, a lot of the shifts in spending have hit maybe sales and marketing before 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 it's I think it's too early to comment on that.

1:01:25 Thank you very much. Your next question comes from the line of Max Masucci of Canaccord. Your line is open.

1:01:38 Hi, thanks for taking the questions. So first on the COVID-19 test, would you be looking to go after sort of a large-scale test We were doing this kind of testing at Gartner for our own employees for weeks now and the vast majority of

1:02:16 and many other cases are the symptomatic people. And capacity per meeting, I think this is the right way of doing it, like testing the symptomatic patients. Having said that, I think there are some even needs in the symptomatic front, in the essential businesses and people on the front line of this disease that they need to get priority attention. There are some even unmet needs there. to some extent, then I think hopefully we reach today that asymptomatic patients can get screened. That's our belief, and that's even our mission in the oncology space, find it early and deliver results and interventions earlier, and that's the way to improve outcomes.

1:03:07 So the same thing is true in this space. In terms of employers, definitely there are a bunch of companies who are interested in the compliance on the essential business side. They have employees on site now or they want to bring employees back on site and they want to make sure they do it as safe as they can. So there are a bunch of employers who are thinking about what should be their strategy to increase safety in their working market. And I think that tells us there are a lot of opportunities for partnerships here.

1:03:44 Great. That's helpful.

1:03:45 Maybe one more.

1:03:46 So are you seeing or do you expect to see some elevated interest in the use of Lunar One in the adjuvant setting during COVID just to inform better decisions around limiting the number of immune-suppressed patients? And then are there any new opportunities that might be popping up as a result of this?

1:04:11 So currently we don't have a LunarOne clinical test that we basically gave broad access to it to oncologists. We have a clinical version of our LunarOne 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 position to comment Thanks for taking the questions.

1:05:12 Okay, well, thank you again.

1:05:14 I hope everyone can stay healthy and safe in this challenging time. Thank you. Thank you. Ladies and gentlemen, this concludes today's conference call. You may now disconnect.