Q1 2020 Earnings Call
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Ladies and gentlemen, please standby your problem solving and momentarily once again think every patient simply standby.
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Ladies and gentlemen, thank you for joining.
As far as in a tariff Inc.'s first quarter 2020, any to conference call at the time off because they tend to listen only mode. After the speakers presentation. There will be a question and answer session.
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I would now like to turn the call over to Mr., Michael Brophy Chief Financial Officer. Thank you and please go ahead Sir.
Thanks, operator, good afternoon. Thank you for joining our conference call to discuss the results of our first quarter 2020.
So on the line its E. Chapman, our CEO, Bob Sherman, Chief operating Officer, Solemnly Boskovich General manager of oncology and Paul billing Chief Medical Officer.
Today's conference call is being broadcast live via webcast.
We will be referring to a slide presentation that has been posted two investor summit Terra Dot com a replay of the call will also be available at investor gotten the Terra Dot com.
During the course of this conference call, we will make forward looking statements regarding future events in our anticipated future performance, such as our operational and financial outlook our assumption.
For that outlook.
Impact of the Cobot, Nike pandemic on our business and operations.
Market size and partnership clinical studies opportunities and strategies and expectations for various current and future products, including product capabilities expected release date reimbursement coverage and related effects on our financial and operating results. We caution you that such statements reflect.
Our best judgment based on factors currently known to us and that actually events or results could differ.
Please refer to the documents we file from time to time with the FCC, including our most recent form 10-K or 10-Q in the form 8-K filed K filed with today's press release, those documents identify important risk and other factors that may cause our actual results.
To differ materially from those contained in or suggested by the forward looking statements <unk>.
Forward looking statements made during the call are being made as of today. If this call is replayed are reviewed after today. The information presented during the call may not can paint current or accurate information.
Harry disclaims any obligation to update or revise any forward looking statements. We will provide guidance on todays call, but will not provide any further guidance or updates on our performance during the quarter unless we do so in a public forum.
We will quote a number of numeric or growth stages, as we discuss our financial performance and unless otherwise noted he says referenced represents a year on year comparison.
Now I'd like to turn the call over to Steve.
Great. Thanks, Mike Good afternoon, everyone and thank you for joining US today, we're going to review the highlights from the quarter summarize the impact to covert 19 on her business in our response and give you an update on our clinical and commercial progress in transplant in oncology.
Oh until the highlights we posted 94 million in revenues any 52% gross margin in the quarter, which is by far the best quarter, we've ever had as a company and significantly above the range of 89 to 91 million, we preannounced Q1, with the largest sequential quarter on quarter unit growth in the company's history.
Despite the disruption in March from covert 19.
Revenues grew 41% over Q1 2019, driven by the strong volumes in another positive quarter for average selling prices. We were also very pleased to achieve a cost of goods sold of $202 per unit session dinner lab very close to the 200 dollar per unit level, we had set as a long term.
From target I will spend more time on both the S.P. in Cogs later in the call.
We also witnessed a very successful early launch of our prosperity tested the kidney transplant space. They very short timeframe, we felt orders from 45% at the top 50 and 37% at the top 100 transplant centers, but volume. We also activated 18 cops enters into proactive registry trial and.
Rolling 145 patients. We think these exceptional initial results indicate significant interest for a more accurate donor derived cell free DNA test.
We also responded very well to the Kogut 19 outbreak we were very early to implement key safety protocols for employees in our lab, which has continued running any high capacity with no disruption and we were able to scale our remote ordering capabilities can do levels as we've seen record demand for this service in March and April.
The ability to maintain high quality monitoring of patients away from medical facilities expansive clinical utility of our suite of tests to help patients get the care they need during this crisis.
We were also pleased to tee that coverage for average risk and I P. T has been expanded during this time by an additional 20 million lives. We've seen positive additional reimbursement from his change you're ready and we will continue to make the case to more large payers that are not yet covering and I P. T for all women.
As many of you are already aware, we completed a 279 billion dollar convertible debt financing in March the notes habit seven year maturity in a two in a quarter percent interest rate. We used about 79 million of the proceeds to pay down our senior secured order that credit facility, which we had put in place when the share price.
In the single digits and had a roughly 11% coupon. So we think we've improved the balance sheet with that deal and also added about 200 million in cash to further bolster our cash position.
The next slide shows a more details of our performance in the quarter, we continue to see volume growth across both for rising carrier screening and Panorama and I P. T. As we delivered the largest sequential unit growth in company history. We believe in the terrorists now the clear market leader by volume and I P. T testing.
With more than 2 million commercial test performed we have publish on significantly more and I P. T cases than any other company, we have a highly technically differentiated product and we now have multiple unique critical features that are unmatched by our competitors our strategy to combine are differentiated product with extreme focus on user.
Variance distributed through a highly trained direct commercial channel is working very well despite the impact of could 18 revenues and gross margins were also a record and this is largely due to the volume growth in improvement we've seen it or is fees.
The next slide shows our historical revenue trajectory over a longer time horizon, we set a long term goal of revenue acceleration driven by new products Ace P. improvements and volume growth, we've clearly been able to drive that acceleration or revenue in the last four quarters yourself with meaningful contributions from prosperity.
In transplant and signature in oncology still ahead of US we feel like we're very well positioned to come out the other side of the Coke 19 crisis in a strong long term position.
The next slide summarizes our response to the code at 19 outbreak compared to many in the industry. We think we're weathering. This this disruption well we've kept continuity of operations in or lab, and we've been able to fulfill record demand for mobile ordering and mobile blood draw capability.
For positioned to take care for pregnant women transplant patients and cancer patients. We offer a web based platform that allows the doctor to order the test completely remotely patients can then schedule in mobile visit.
Their blood draw will be performed at their house by qualified for bottomless and the blood is then sent to our lab like normal we've been working on this application for years as we handled roughly 10000 mobile blood draws in 2019, although the majority of a reproductive health orders are still coming through the usual office channel, we've been really pleased with how smoothly.
This increase in demand has been handle.
As we discussed when we announced our preliminary results for the quarter, we experienced about a 15% drop between the average weekly volume in the first 10 weeks of the quarter compared to the last two weeks if March the drop was not 15% across the board hardest hit where volumes from outbreak hot spots like New York in New Jersey and.
Audience from our Invitro fertilization channel.
Have you have clinics were effective we presented prevented from initiating new patients. But these are very determined customers. So expect to rebound winter clinics can fully reopen again.
In fact, just recently the relevant professional society, the American Society reproductive medicine reaffirmed the essential importance of timely access to procure study treatment paving the way for gradual resumption of patient care.
There was obviously a lot of confusion around these locked down orders in late March and we're already starting to see that the volume is recovery in April as doctors and patients get back on schedule and make adjustments having said all that we went through our guide for the year, specifically because the cadence of the recovery it's hard to forecast.
As I mentioned the top of the call. We did see some significant movement on the average risk coverage front in response to the cobot outbreak society for maternal fetal medicine posted updated practice suggestion, noting that positions could consider using cell free DNA testing in lieu of additional ultrasound tests.
Days later Aetna updated their coverage policy to temporarily cover and I P. T for all women. This represents a significant increasing covered lives and we think this move these moves bode well for the continued adoption of and I'd P.T. as the standard of care for all women in the future.
As we mentioned before we're not getting paid on a large portion of the average risk and I Pts we perform today getting full coverage on an ongoing basis can have a very meaningful impact on a gross profit we estimate from the volume we do today alone full average risk coverage would be worth roughly 60 million in gross profit.
And that figure does not include the significant uptick in volume from deeper penetration into the very large average risk where market.
Okay on now to the details of our unit economics Asps in Cogs for those of you that might be new to the terror earnings calls we track these metrics carefully to measure our progress towards cash flow breakeven for the reproductive health business and along with our volume and revenue growth. We consider these key metrics for measuring.
Our execution.
We're really pleased to have good news on both ASP is in Cogs. This quarter as you can see on the page.
On Asps recall that we initially guided 2020 revenues with the assumption that ASP as regard to modestly declined this year.
As we sit in March this was largely out of conservatism, but we've been pleased to continue to drive ASP is higher in Q1.
This is largely due to improving the fraction of time peers reimbursed or contracted rate with us as long as the underlying pair environment remains relatively stable. We think it's piece can also remained stable.
Especially because the expanded average risk coverage I described did not come into effect soon enough to meaningfully impact Q1.
The drop in Cogs was due to R&D initiatives executed in 2019 and lab in supply chain efficiencies plus the rapid increase in volume we experienced in the quarter.
Those of you have who have followed us for years now that we ought to report lower cost per unit in Q1, because the lab runs extra week to get the job down in the immediate term when faced with higher volumes, we expect Cogs per unit to be higher than this level in Q2, partly because volumes will be lower over the same fixed base and.
We have implemented some cobot 19th specific measures like hazard pay for employees that we expect to temporarily effect hogs, having said that these Q1 numbers did not include the Cogs projects being launched during 2020. We previously described and I think the Q1 performance coupled with the Cox project, we tend to watch over there.
Next 12 months choice. It we can push this number beyond the 200 threshold overtime.
Okay now onto organ transplant during our early access program, we've seen significant interest from the top transplant centers. We've said for a long time that are unique product offering which has best in class sensitivity and negative predicted values, including the ability to identify the important T cell mediated rejection would be seen is.
Welcome to alternative for the transplant community that's exactly what we've seen in very short order. We've now seen roughly 45% at the top 50 centers place orders and 37% of the top 100 centers by going in place orders. This is really incredible and shows the need for a test like ours in the market.
Strong response, we've seen thus far indicates the long term potential of our ability to penetrate this market.
We're also seeing strong enrollment in our proactive trial as a reminder, proactive will follow 3000 kidney transplant patients over a three to five year period to examine the utility of prosperity to accurately identify organ rejection.
He very short time, Weve activated 18 of the leading centers with many more coming online soon and we've already enrolled 145 patients. This is exciting and has outpaced our expectations. Although the coded 19 pandemic, obviously impacted or ramp we're seeing volume growth again in part due to an interest in.
Remote monitoring and over the long term, we're excited about building a significant business and transplant space.
The next slide is just the same chart that we have shown since we announced the presentation of or validation data.
We've hit every milestone toward a commercial launch on time, we think we demonstrated in our early access phase that we can scale to volume in or just awaiting that iridian LCB before we can start billing Medicare as a reminder, and iridian Polish the guidance in a multi ex program, where we've already received positive coverage and we expect iridium final coverage.
Decision to come in soon.
Now I'd like to hand, the call over to Solomon for an updated update on our progress in oncology Solomon.
Thanks, Steve.
On the partnership front.
Our work continues under our development programs with BG and Foundation medicine.
And in both partnerships, we expect initial engagement from pharmaceutical clients this year.
In our direct pharma business, we continue to see very good momentum in terms of contract to future revenues, including prospective clinical trials as well as retrospective studies using banks samples.
In the direct clinical business as we've described previously we hired the first phase of sales reps for signature late last year and restarted and early access program with top academic institutions now having worked with the majority of the top NCCN centers. We were pleased with our early trajectory in Q1.
And although the ramp was impacted due to covert 19. We've also received significant interest in using Cigna Terra as a way to help mitigate the effects of the pandemic. We're now seeing volumes start to grow again in April.
Cancer care has been significantly disrupted by the Corona virus outbreak of cancer patients are elevated risk from exposure. Many standards surveillance visits and see cheese scans have been canceled.
Doctors are looking for a remote monitoring solutions and many are reevaluating the risk benefit about different chemotherapy, which can weaken the immune system.
An article published last month in Jamba about oncology practice during the current 19 pandemic actually called out early stage colorectal cancer, specifically as an example of where I've been treatment should be adjusted in the new environment.
We think cigna character and really helping these scenarios as summarized on this slide with our adamant and surveillance programs for stage, two and three colorectal cancer.
And especially with our remote blood draw capability as we've described previously we believe this clinical indication has the opportunity to translate over a million tests per year, which gives you a sense of the size of these oncology markets. We're just beginning to unlock.
[noise] utility of signature was highlighted recently in a new pure reviewed Kiss report published in J C O precision oncology, demonstrating the technologies capabilities and yet another type of GE cancer. This time in a softer geo cancer.
Study, which was published by co authors from Harvard University, and the Dana Farber Cancer Institute Falls, a 72 year old man with recurrent stage three suffered you'll cancer, whose recurrence was detected 350 days.
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Graphics imaging.
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Going no signs of cancer.
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Additions escalated to a pet scan, which revealed a four centimeter nodule and his liver that was later surgically removed.
Furthermore, the bespoke asset in this case was designed to based off of a foundation one tissue chest that had already been ordered as part of the Piceance standard care.
Exactly the way, we envision the partnership working.
We're very pleased about this demonstration of the potential of our technology and on the proof of principle for our collaboration with Foundation medicine.
We also continue to expand our leadership position with validation data in MRT testing applications for the first time, we and our collaborators were awarded an oral presentation at ASCO with an expanded dataset in early stage colorectal cancer.
After it was holding or virtual meeting this year and we look forward to presenting this data along with three other accepted posters. We also have an oral presentation coming up.
ESMO Gi later, this year and posters at multiple conferences in 2020.
On the publication front. In addition to the five papers, we have already published.
We have four papers currently IND submission, including a pan cancer set of patients treated with immunotherapy in inspire study.
And the ice by two data in Neoadjuvant breast cancer.
Meanwhile, we have new cohorts from at least five different cancer types currently undergoing analysis in our laboratory, which we plan to use to drive future publications.
This flow of new data will help unlock additional clinical indications and support the growth of our pharma business, where studies range across many different cancer types. Some of the data expected. This year will actually be presented in collaboration with some of our pharma clients.
All of this was an addition to the perspective trials that we announced previously in colorectal cancer.
I'm not going to go into the details on all these studies again, but new investors can still find our prepared remarks from past events on our website. The key updates here is that we're still moving forward on all of these trials ended the second quarter of this year were scheduled to enroll the first patients for both the circulate idea trial in Japan, and our Ron spoke.
CRC trial.
Finally, we're still on track to receive final coverage decision from Medicare and the second half of this year as we've discussed previously the public comment period ended in Q4 of last year, which went smoothly and there's generally a 12 month window in which Medicare would publish the final LCD.
We're also in active discussions with Medicare on coverage for new indications and I look forward to sharing more details on not in the future.
Now I'm going to hand, the call over to Mike to review the financials Mike.
Thanks Solomon.
You can see the summary results for the quarter on the slide as Steve mentioned earlier in the call. We came in at 94 million for the quarter, which is above the Preannounced. We gave in April the key driver for the additional revenue above the pre announcement was additional cash receipts for tests that we reported down in prior periods as we've talked about in the past.
We're pleased to see our approach to revenue accruals for quarters. In 2018, 2019 has proven to be conservative and cash collections for those periods continue to exceed expectations.
As Steve described the revenue and gross margin performance was primarily driven by strong volume growth and continued improvement on both ask season Cogs.
We made progress would both be guy and ask them I and that revenue recognition contributors to the quarter, but that partnership revenue was slightly lower in Q1 versus Q4 of 29 team.
We're pleased that the reimbursement environment has remained stable. So far this year, we're cautiously optimistic that weekend maintained its performance through the balance of the year, we do expect Cogs could move up as Steve mentioned from this low level and the next few quarters. As we you would be additional expenses related to ensuring our lab space and productive and as.
We expand capacity, but I think this quarter demonstrates we can get blended cost of goods sold per unit below $200 over time, particularly for the reproductive health business, which currently makes up the vast majority of our volumes.
On the operating system front, we saw increases over last year as expected as we ramp the commercial and clinical trial effort in both transplant and oncology expenses into reproductive health business remain stable, even as volumes continued to ramp that demonstrates to us that our path to cash flow breakeven in that part of the business.
It's achievable when the world gets a little more back to normal and we can resume growing volumes.
As you know we withdrew the guide for the year given the unknown around the cobot Nike situation and Steve gave some color on where specifically we are being impacted while the preliminary data on a on weekly receive units in April in early May looks encouraging we think it is too early for us the forecast precisely when we can return to growing.
Yes, so we certainly expect that to happen this year based on everything we know today.
With the convert deal now done and the overhead note retired we feel we are in a very strong cash position and we'll be able to execute on our plan. Despite this cover 19 disruption.
With that let me hand, the call over to the operator for questions operator.
As a reminder, so that's the question you'll need to pass Taiwan and your telephone.
Well, it's all your question please press the pound key.
And by the compound kill any roster.
My first question comes from the line of Doug Schenkel with Palin Your line is nothing.
Hey, good afternoon guys.
So as you mentioned in your prepared remarks, consistent with what you're talking about earlier on the last two weeks of a quarter you saw a drop versus Q4 weekly levels of around 15% you've talked about seeing some improvement. Since then so just to try to unpack that a little bit more Q2 volume is typically lower than Q1, but.
You had a lot of momentum through the first 10 weeks of Q1.
If it weren't for coated would you still have expected Q2 volume to be lower than Q1, but that's the first part second part is.
How much better has volume Ben since the end of Q1.
And then the third part is.
In hindsight as if you tried to dissect that's a little bit more what's the 15% drop versus trends likely a function of the population density and presumably your market concentration in certain hot spots and is the improvement sense a function of not just your response, but also the back.
That as new hot spots of popped up maybe you don't have as much exposure.
Yes. Thanks, Doug This is Steve So I'll just clarify what we said in his prepared remarks is the last two weeks of March were down about 15% from the.
Average in the first 10 weeks at the quarter.
You know that that sort of first 10 week period was in blow out you know record period of time for us. So that the drop is roughly from sort of 15% of that and it was roughly in line with our Q4 weekly volume average.
We have seen the business recovery, we're actually quite nicely in in April but.
But it varies somewhat depending on which segment to the business, you're looking at it which region.
Looking at says we mentioned some of the harder hit areas I'm like Ivy F. for example.
Although.
The outlook is positive as we've we've seen these new statement come out for me SRM that at least and the guideline for a little bit you know, we're still waiting to see that come in the appointment get reschedule no. Other areas of business, we're actually back to a peak levels or in certain segments, we've actually now exceeded.
Previous peak level. So we're feeling good about about the recovery and good about the trajectory and.
April I do think the you know the ability to go out and close raw new customers. You know is impacted somewhat so while we're getting back the business that we lost I do think certain customers, we will be able to close and we have seen that occur.
Yeah, I do think in general that sort of pipeline of closing a lot of new businesses, it's pushed out slightly.
Okay. That's helpful and in terms of new practice openings I would think that would be a little more challenging right now just given its harder to get in front of practices. So is most beer growth right now most of your volume kind of same stores versus new new.
[music] volumes and if so is that something that we should be cognizant of you know maybe not for Q2, but as we think about second half trajectory.
Yeah, Yeah, well look I mean, I I do think we've definitely seen some signs that we can close new customers in this environment and we have put a lot of effort into digital activities like many others haven't we've set up this you know very slick mobile for bottoming capability and in certain areas you know a call.
Energy and organ transplant for example, I think it's a it's very helpful for those patients to not have to go into the office. So we are seeing some new accounts come on where they are interested particularly in the in the mobile capabilities or the ability to monitor patients remotely I think our first goal was to to get you know build back up to the.
Existing accounts in same store sales and then <unk> you know at the same time go out and look for new customers that they want access to the service than we've seen both occur new customers closed and the base business coming back, but I do think.
It comparing it to an environment, where theres no kogan pandemic certainly the ramp of closing new customers is not going to be the same as it would be if we were full steam ahead in reps walking into offices every day. So we can close new business and we are but it's not going to be at the same pace that you would've seen otherwise.
My toward a loss Mike would you also want to add anything to that Mike No settlement anything to add yeah, I think you covered it.
And then last one for me any discussing with some of the pairs that have moved to temporarily expand and IP to cover to average risk patients that would suggest these decisions could be made permanent.
Yes, Mike you want to take that.
Yeah. So.
Thanks for the question is the.
The the coverage policies that we've seen come out have had.
Explicit.
I didn't answer them linking them to the Corona virus.
Outbreak in there and they're they're limited in their time duration. So there's nothing in the document that would tell you that it's it's going to go on for an extended period of time.
But we just got to see I mean, I think it's instructive that that the expansion of coverage policies seem to come right on the heels.
Additional practice recommendations from the professional societies and so.
I think well, we don't know I think we would expect.
That those kind of coverage policies would would follow the the professional society recommendations. So it's possible that it could continue.
Okay, alright, thanks, a lot.
Thank you on our next question comes in a line of Tyco Peterson with JP Morgan Your line is open.
Hey, this is all any on for Tycho. Thanks for taking my question.
So firstly I was wondering if you can help frame the at now opportunity you mentioned that today, you're seeing about 60 million in unreimbursed gross profit.
Average freight volumes I'm just wondering if that includes not only what piece of that lies at night and the remainder how much it's United.
Yeah, Mike why don't you take that.
Yeah sure so.
Just hasn't as background just about one there's about 210 million covered lives commercial covered lives in the United States.
Got 110 million of those wives already had a policy covering average risk and IP.
And Oh the remaining.
No is circa 20 25 million covered lives and United is bigger they're more in the 40 to 45 million a covered lives range, depending on how you you count some other ancillary clamps. So if you think about adding as a percentage of the total commercial covered lives or their circa 10% of the commercial lives in United States.
And I think that's that's a that's a reasonably good approximation of their impact on our business. So certainly it's a it's a tailwind for us it's not a you know it's an enormous change and our ASP trajectory, but certainly it's certainly a contributor the balance of the of the commercial covered lives for average risk.
It really is kind of a long tail and you've got Humana, maybe the next biggest one and then it gets into assortment of blues plans et cetera. So.
It's a it's a good contributor and it's not the but the majority you can see for my remarks that United's obviously quite a bit.
Thats helpful. Thank you and then I would also wondering in terms of I'm. The question of whether that's great temporary policy could be a precursor for permanent quite.
Whether you could comment on what we could see come out of the next review [laughter] policy, which is I believe schedules for me it and whether you had any conversations with them. After the temporary policy was released.
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Yeah.
I'll comment on that so you know generally when you have these discussions with the plans they.
You know they they keep the information flow pretty.
Pretty limited a they don't want to give away anything I mean public companies et cetera.
So you don't get you know exact road map, we do feel positive long term with you all of these large payers.
They generally tend to follow the professional societies you know, we we've said before that we heard that there's something positive coming from ECOG. We continue to hear that in fact, we heard that again.
More recently and if there's something drafted that's going to be released in the near future. That's positive. We don't know what it says and we don't know exactly when it's going to come out, but we do know that that that's there in the background.
I also mentioned.
Sort of Backstopping all of this is a the smart study. So if you remember the details of the smart study to Terra Prospectively study.
20000 patients over a period of several years I think the trial started roughly five years ago, and we expect that data to be published later this year and we think that will actually be the largest.
Perspective, and I P study looking at both chromosomal Aneuploidies and micro deletions, that's ever been done in the field of in IP and we think that study has a very significant opportunity to move the market. The rest of the way forward. If we're not there by that.
With respect to.
In United and others, specifically you know obviously, we're doing everything we can.
To engage with them and moved the business forward, but we really don't know exactly what their plans are going to say, we expect them to track the society guidelines.
Thanks, and then lastly, I was wondering also in terms of the delayed you've seen in the last two weeks of March I'm, just wondering specific to and I could see how much it can be postponed due to the seven week testing when no I'm for NTT and if you can talk about whether some of those patients I'm could come back soon.
Rather than later and any other dynamics you can see there.
Yes, we think there you know there's a period of time, where ever have rule that sort of figured out how they were going to manage that last couple of weeks in March and we sort of see that as as probably you know the worst period of time for disruption on the business and I think across every sector of our business whether it's the different.
Products in prenatal or whether it's you know transplant oncology we have seen.
The volume recover in a pretty meaningful way sense that that low in the last two weeks of March now some of that.
His practice is figuring out how they're going to operate in this environment and then pushing to play button restarting someone that is us going out in closing new customers are enrolling new customers in our mobile in remote solutions and then some of it is a is catch up on on patients.
Yeah, we haven't seen we've gone through looked at you know gestational age isn't things and we haven't seen a big bolus of a catch up patients come back in on on the and I P. T front.
But I don't think that they were they were pushed out significantly you know such that there would be a very meaningful shift in there.
Average gestational age anyway.
Great. That's helpful. Thank you.
Our next question comes from the line.
Matt Cici with Canaccord Genuity your line is open.
Hi, Thanks for taking the questions.
Are you seeing any evidence of a share gains and and I P.T. as certain larger competitors are concerned inundated with coven 19 testing and do you have any expectations. There I know we've seen a large central labs report on sharp volume declines for testing that's not related to cover the 19th.
Yes, certainly we've been at a very competitive environment for a long time I mean, I think as you. All know you know we were the fourth and I PT to market. You know we're now the market leader. So a lot of our growth does come from a volume.
Gains for competitive wins.
I think many of the a smaller.
More targeted competitors are offering the same sort of mobile type capabilities, you know that we're offering I'm not sure necessarily whether you know the big box laboratories are.
Going after it in that same way I'm sure. They they will if they're not already.
But we're continuing to win on the quality of our product in the unique Differentiators and you know our significant focus on user experience the advantage for us as we entered into this period or was that we already had all these remote services set up so remote genetic counseling, we have chat.
Lots that can.
Talk to the patient in various ways that we built in house, we Didnt go out and acquire those capabilities, we just built them.
We did more than 10000 mobile draws in you know in 2019, so as we saw that significant ramp in mobile.
Accessibility being requested from our physicians, we were able to step in and service it.
Without a lot of operational challenges.
Great and then can you just maybe speak to any covert 19 disruption you're seeing the major Max, namely Meridian and so that's shaped your opinion about the timing of the Finalization for signature colon and then any new any new color you might have gotten recently.
Or on pricing or are you still expecting to be pegged to an existing monitoring test on the market. Thanks.
Yes. So you know we're in constant contact with the bold Dx program you know as we mentioned, we've we've done pretty submissions on other products or any oncology space, which we're very excited about and we're continuing to have those discussions about additional products.
Certainly I think there's a lot to focus on at this point.
By the various.
Max you know, there's generally a timeline to which.
They need to issue a the final coverage decision and we expect a oncology to issue within that.
Timeline that that's been outlined we don't expect there to be any sort of significant disruption and again, we continue to be in direct discussions with the key decision makers and we're feeling very positive about not only the colorectal tests, but also the discussions that we're having Tom about about other pro.
Alex and oncology on pricing, we don't have any additional updates at this point, we expect that to occur after the a final mold Dx coverage decision goes in place.
Great. Thanks for taking the questions.
Thank you and our next question comes on line of Alex Nowak with Craig Hallum. Your line is helpful.
Great. Good afternoon, everyone. This is actually will supinski on for Alex here, Thanks for taking the questions.
First one for me you know on transplants, you recently published the progress of the proactive study showing enrolled showing enrollment among sites host prosperity news beyond the registry trial being doctors, who weren't enrolling for the registry study you know how is the test adoption there.
Yes, so we haven't announced a volume numbers there, but we did talk about the penetration I think we said a 45% of the top 50 transplant centers by volume and 37% of the top 100 transplant centers by volume have used the product.
During the early access program.
Some of those are engaged in proactive and you can just kind of run the math and figure out you know.
Which ones are proactive or not but yeah. There's many that are outside a proactive that are using the test we see really handful of different types of accounts I think some have specific patient cohorts that they want to order donor derived testing on I think you know some one order it more routinely as.
Part of their patient care, but overall, we believe this is a very large market opportunity that is only about 5% penetrated today. Despite all of the.
I think competitive activity between knots and others in the field of there's there's an enormous amount of greenfield opportunity. When you just run the numbers on the total number of patients that that need to be monitored per year. So we feel excited about it.
The early feedback that we've gotten from physicians really meets our expectations, both and what they're looking for in a product and second to in the capability to really penetrate.
And make this a much larger than 5%.
Got it appreciate the color there and then second one for me you know Mike the Terra obviously, followed the approach of other companies and suspended guidance at this time, but you know just with the temporary coverage of that not the potential UN H share gains during cold that ability to keeps in sales with remote monitoring and the pipeline still on track is it fair.
So to say that you could still hit the original guidance range that you guys provided beginning here.
It's certainly possible, but you know Steve touched on one of the key variables, which is new accounts starts and you know just circling diagnostics you just need to sales rep to be in the in the office or in the center would the physician to it to get a new account started and obviously physicians are much more accommodating to remote start ups now than they.
They had been previously, but that's just a it's very hard for us and forecast a and so I mean as we look into right. Now we think it's wise just so just a monitor that and.
Over the course, the summer we'd like to get some more data points honestly would assume environment and they come back to you in August.
Got it understood. That's it for me Thanks, guys are taking the questions.
Thank you I'm not showing any further questions.
Great well. Thank you so much we appreciate you joining take care.
Ladies and gentlemen, this does conclude program you may now disconnect.
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