Q3 2021 Natera Inc Earnings Call
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This conference call is being recorded today November 4th 2021.
I would now like to turn the conference call over to Michael Brophy Chief Financial Officer. Please go ahead.
Thanks, operator, good afternoon. Thank you for joining our conference call to discuss the results of our third quarter of 2021 on the line is Steve Chapman, Our CEO, Paul Billings, our Chief Medical Officer, and Tom and Moskovitz General manager of Oncology Today's conference call is being broadcast live via webcast, we will be referring to it.
Slide presentation that has been posted to investor Natera Com a replay of the call will also be available at Investor Natera.
During the course of this conference call, we will make forward looking statements regarding future events and our anticipated future performance, such as our operational and financial outlook and projections, our assumptions for that outlook, Mark and Si partnerships clinical studies opportunities and strategies and expectations for various current and future products, including product.
These expected release dates 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 actual events or results could differ materially. Please refer to documents we file from time to time with the SEC, including our most recent Form 10-K or Q and the form 8-K filed with today's press.
Release, those documents identify important risks and other factors that may cause our actual results to differ materially from those contained in or suggested by the forward looking statements forward looking statements made during the call are being made as of today that this call is replayed or reviewed after today. The information presented during the call may not contain correct or.
Or accurate information <unk>.
We disclaim any obligation to update or revise any forward looking statements. We will provide guidance on today's 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 changes as we discuss our financial performance and unless otherwise noted each such reference reference.
At a year on year comparison, and now I'd like to turn the call over to Steve.
Thanks, Mike Good afternoon, everyone and thank you for joining US we've got a pack session pool of announcements so let's get into the recent highlights.
The very strong momentum in Q3 continued as you can see from the metrics in the first bullet.
We processed 407000 units in Q3, which was approximately 55% growth over the same period of last year.
Total revenues and product revenues were both up 61% and 62% respectively over the same period last year that acceleration is being driven by continued strong growth the women's health products and big contributions from my apology and transplant products.
Those products are now large enough to shift their growth rates upward.
We heard a lot in the market during the quarter about the impact of Delta variant was having on the health care businesses, but as you can see from our Q3 volume we were able to blow through any headwinds COVID-19 presented.
As a result of the continued momentum we are raising our revenue guide beyond the range. We just gave a couple of months ago. In August we are now guiding revenues to be $615 million to $625 million for the full year.
We started the year guiding revenues at $500 million to $525 million.
So the top end of our range is now roughly $100 million above where it was at the start of the year that gives you a sense of the traction we're having and we continue to see across the company.
Mike will get into the full details of the guide later in the call.
In addition to the significant unit and revenue growth, we've got a set of transformative announcements in the transplant space.
Kidney we've continued to make significant progress first is the launch of prosper with quantification, which is a new technique only offered by the tariff that has shown improved performance over earlier message that report donor derived cell free DNA fraction alone.
Second is the announcement of the results of the Trifecta study, which we believe is the largest prospective multi site fully biopsy match study ever performed in the kidney transplant space.
Actual results exceeded our expectations and we believe could eliminate the need for costly multi modality approach is to bolster test performance.
I'm also excited to discuss the major new prosper commercial launches in heart and lung in both Oregon as a commercial launch announcement was supported by significant new prospective datasets that we believe can redefine these fields.
In oncology the major announcements continue to unfold we had another strong colorectal study published in clinical cancer research were reintroduced signature of velocity is a clinically useful metric.
The study demonstrated the value of calculating circulating tumor DNA growth rate over time or velocity, such that patients with fast growing tumors fare much worse than patients with slow growing tumors lots.
Philosophy, he can't be calculated if you're only reporting out positive or negative result, so we believe this will become a competitive advantage for natera and recurrence monitoring and we'll spend some time on this later in the call.
More broadly I think the launch of quantitative approaches in both oncology and transplant has a lot of parallels with our watch the fetal fraction metric for Panorama back in 2013 at that time, no. Other ni PT reporting on pedal fraction, but physicians really gravitated to our test because of that result, and the metric is now.
The gold standard and a requirement for the field these new oncology and transplant metrics provide a window into a patient's underlying biology, which can offer physician crucial context, when deciding how to incorporate a test result into clinical decision, making our technology lends itself to these types of metrics further differentiating the <unk>.
Clinical utility of our products across all areas of our business I'm pleased that it continues to be a leader in the industry in this area of innovation.
We were also very pleased to secure another major competitive win by being selected by NRG oncology for the U S arm of the circulate trial you have seen the significance of the datasets coming down that circulate Japan, and we now think winning the critical U S arm puts us even further ahead in terms of developing prospective validation day.
For colorectal cancer.
These two trials together with the work, we're doing with BG, I and China make up the largest commercial CRC MRV markets. When you consider both the incidence and the reimbursement landscape.
Although we aren't going to do a deep dive on our signature of pharma trials today, we're now fully enrolling patients into both the phase III and vigor in zest trials, we discussed on our last call in our pharma pipeline continues to build.
We are also now offering a broad plex product to our pharma partners and you are you are setting.
As Youre aware mature can multiplex thousands of probes in a single reaction so offering a broad <unk> test in the range of 50 or 100 or more targets, it's easy for us to deal with.
We've only seen very targeted interest, thus far and the broader flex offering but for those who want it. We now have it available we've been doing this kind of work upon request for a long time, but we've now made it available as part of our standard menu.
In addition, Tara has developed a series of signature innovations that intends to introduce in 2022 and 2023 as you know from our Ni P T.
Business, we're constantly innovating and pushing the limits of the technology.
I'm also pleased to announce the progress of the critical launch of signature in China with our partner BG I recently.
Recently, BG I kicked off a multi site prospective trial in Gi cancers, including colorectal cancer. The study plans to roll roughly 500 patients and includes many of the top academic centers across China B.
P. G I plan to expand on this initiative in just kicking off a series of investigator initiated trials across other cancer types Guinea.
Gaining support from top academic centers and Kols is important for broader clinical launch which requires the Chinese FDA approval.
<unk> will take several years to achieve.
Finally, we're excited to announce the details of our roadmap in early cancer detection, we signed a partnership with our house University. It gives us access to perspective 40000 sample biobank of patients screened for colorectal cancer. In addition, we've got an exclusive option to license our houses IP and we have.
Access to their methylation signature, which is performing very well across all stages, which we plan to combine with our own methylation and T DNA technology.
As you can see we've had a very busy quarter I'll now jump into each of these starting with the unit growth on the next set of slides.
Our unit growth has really been accelerating recently and I think this longer term historical view gives us some context to the growth trajectory. We've been on for the last four quarters, you can see that while we've made steady if lumpy progress in prior years. The business has rocketed upward on a much deeper ramp since Q3 of last year that has not occurred.
Incidents in women's health, the new <unk> guidelines came out roughly 12 months ago.
Launched both our transplant and oncology products in the second half of last year.
We don't think this is a one year trend the ni P. T market is still very underpenetrated compared to the four to 5 million pregnancies in the U S. So there's a long way to go and of course, we were just getting started in both transplant oncology both of which were starting to see play out a significant opportunities.
On the next slide you can see the volume growth is clearly translating to revenue growth as well you can see once again the scale up and growth we've experienced in the last year. This is driven by both volume trends and also continued improvement in the realized.
Revenues per test or ASP, we saw.
Saw another nice to increase in the blended asps piece of the business over Q2, which continues a multi quarter trend going back to last year, we benefited from the volume mix shifting towards the newer higher priced products and we also had some healthy appeals wins on older claims that came in through the quarter in women's health, Mike will spend more time on the Asps later in the call, but we still have.
Plenty of room to run on the asps across their various products.
Okay. So we got a fantastic set of milestones to know review in Oregon Health I want to start off by highlighting some broader trends that are occurring where they're Oregon health products first we've expanded from a single organ product to now multiple organs with the launch of heart and lung our technology is robust.
And we're seeing it translates well across the organs and a very cost efficient way, which we think offers great a great expansion opportunity for any tariffs.
Second, whereas at one point, we only had retrospective data that's now no longer the case, we now have significant prospected multi site data in some cases, we believe we now have the most significant prospective data in this space.
Third we focused on innovation to improve test performance for example, with the launch of quantification and now we're seeing <unk> that are exceptional from just C. T. DNA alone these trends expanding to other organs producing high quality multi site perspective, dataset and delivering exceptional AUC through innovation all supported path for <unk>.
<unk> growth and prosperity.
In kidney its been a little more than a year. Since we were awarded our local coverage decision for prospera and we started our commercial launch in earnest and we're very pleased with the level of commercial traction were generating so far of the top 100 transplant centers 45 have now implemented prosperity routinely into their practice.
We've also been pleased with enrollment in our registry trial proactive where we now have more than 2500 patients enrolled you may recall, there was external skepticism about whether we would be able to successfully enroll patients into this trial, but clearly we've done an exceptional job this level of adoption among top centers just a little more.
A year into the launch gives us confidence that our commercial plan is working now with the addition of new Oregon's very strong multi site perspective data and our innovative quantitative approach running even better positioned to build on the momentum we've seen thus far.
Let me talk now for a minute about prospera with quantification.
Prospera is now the only commercially available seat gosh cell free DNA test for kidney rejection that provides three values.
The quantity of the donor derived cell free DNA.
Fraction of the donor derived cell free DNA and the total amount of cell free DNA on every report.
Other available cell free DNA tests only report on the fraction of donor derived cell free DNA alone, which has limitations, especially when the total cell free DNA is high which may result in false negatives.
As you can see here on the left side of the slide the percentage of the donor derived cell free DNA as a fraction that incorporates the absolute quantity of donor derived cell free DNA as the numerator and the total amount of cell free DNA as the denominator.
The donor derived cell free DNA. It comes from the donated Oregon and the total cell free DNA, mostly comes from the recipient the fraction of donor derived cell free DNA can change significantly if the denominator or the recipient cell free DNA is artificially increased when reporting donor derived.
Cell free DNA fraction alone like our competitors do doctors need to be very careful about any factors that might impact. The denominator. There are 10 of items on the right hand of the slide that we've identified in the literature that can impact the total cell free DNA are.
Our hypothesis was that incorporating a measurement of the absolute quantity of cell free DNA, rather than just a fraction alone into the result would improve the sensitivity of the assay and that's exactly what we're now seeing in our studies.
To test our hypothesis, we performed the validation study of the prosper with quantification method with UCLA that resulted in a peer reviewed paper published in the journal of American Nephrology, one of the Premier journals. The paper showcase the improved performance from prosper with quantification of 41 kidney transplant.
Nine of whom were experiencing rejection incorporating the quantity of donor derived cell free DNA with the fraction of donor derived cell free DNA improve the sensitivity of the prosperity test from initially identified in seven out of nine cases of rejection to then nine out of nine cases are active rejection, which we then can.
Firm with biopsy. This improvement has now been seen across several different independent dataset, a number of which are in submission for publication.
Most significant data set comes from the Trifecta study, which I'll go into on the next slide.
Yesterday, we announced the results of the Trifecta study. The Trifecta study is a multi site prospective trial being led by Dr. Phil Halloran from the University of Alberta, leading kols in the field.
Study, which included more than 300 biopsy matched samples a greater than 100 biopsy matched rejections is the largest multi site perspective fully biopsy match study ever performed in the space and.
In the study we tested the AUC of prosper with quantification to distinguish rejection from non rejection using <unk> 2019 criteria and we showed an AUC a 0.81.
We then use molecular pathology is the standard and shouldn't AUC a 0.89.
The recent studies suggest that molecular pathology may be a better standards and band, suggesting that prospera may be performing better than previously suspected.
Finally, we also compared rejection versus quiescence, essentially rejection versus exceptionally stable patients, resulting in the AUC of point 91. This last analysis. The comparison rejection to quiescence similar in concept to that used by some of our competitors and their recent multi modality publications.
Unfortunately, it isn't a very useful analysis clinically, which I'll touch on in a minute.
Overall, the Auc's from the Trifecta study are exceptional.
That data is now in prospera with quantification performed very well and at Terra now has the largest fully biopsy match study that's ever been performed in the kidney transplant space.
I wanted to take a second to quickly touch on rejection versus quiescence, because it's easy to get confused on the different types of analyses that are out there.
Rejection versus non rejection is different from rejection versus quiescence quiescence includes essentially only the most stable of stable patients as you can see below this type of analysis excludes intermediate patients, which really isn't practical in a real world setting in most cases, it's not possible.
To determine a patient is quiescent without doing a biopsy first to determine if there are any non rejection pathological findings that is why the vast majority of the papers in the field have assess rejection versus non rejection, which remains the main benchmark for performance.
Do you assess the landscape of testing available keep in mind that the analysis being performed maybe different than the intended use population and just and thus the results maybe less clinically useful.
So far from what we seen multi modality approaches have not been validated in rejection versus non rejection cohorts and their performance in that intended use population remains to be seen.
Okay. The next slide I'm really pleased to provide details on the recent launch of prosper and the heart transplant setting as I said before it's been relatively easy for us to expand beyond kidney to other organs because of our robust core technology. In addition, it's also proving to be commercially efficient because we're able to leverage a lot of the same.
Infrastructure in terms of nurse coordinators and customer support. So it's also been cost efficient for us to enter this space we.
We think prospera heart offers compelling advantages versus our competing tests.
Our validation studies multi site study that included greater than 250 prospective samples collected during 2020 in 2021 for the purpose of validating Prospera heart and another 100 samples from a biopsy matched biobank you could see the results of the study on the right hand side of the page. The initial results were impressive but then.
Further improved with quantification, where we were able to achieve an area under the curve of 0.88.
These are really exceptional AUC isn't a heart transplant monitoring space further underscoring the power of our technology.
What's critical about these results is that the prosper hard tests delivering this exceptional AUC by performing cell free DNA alone and therefore, we believe there is no need for cumbersome and costly multi modality approach is to bolster test performance competitor testing heart must be collected at a site that is.
Set up for specialized handling because the sample must be immediately spun down and shipped on dry ice.
Our test is a simple blood test patients can access or convenient mobile phlebotomy service, which can be important given the frequency of testing. In addition to competitive testing heart churches Medicare twice for every multi modality patient time point since separate DNA and RNA tests are being performed on each patient.
Because we are delivering excellent performance on a cell free DNA based test alone Prospera heart reduces the cost of the system and it's less than half the price the expensive multi modality approaches. We think this combination test performance convenience and cost represents a compelling offering for physicians and patients.
We keep the product expansion opportunities rolling on the next page with our lung transplant launch.
We're getting a lot of the same efficiencies, but this launch the same robust prospera workflow and leveraging a lot of the same commercial infrastructure that we built the sales and commercial teams overlap with the heart team. So again, it's very efficient for us to go after this opportunity.
We think the validation data and results in lung are very strong. The study was run by the lung transplant program at the Ohio State University was presented at chest, a few weeks ago and very well received.
<unk> study examined 204 plasma samples obtained with concurrent bronchoscopy biopsy procedures from 100 and for lung transplant recipients between September of 2020 in June of 2021.
Using the prospera lung test donor derived cell free DNA levels were compared across clinical history pathologic diagnostic cohorts. During the study 35 episodes of acute rejection or analyze this study represents the largest trial of a commercially available donor derived cell free DNA tests for lung transplant assessment and once again.
The AUC was incredibly strong underscoring the power of our technology.
For both the heart and lung products, we plan to submit dossiers for Medicare reimbursement under the existing local coverage decision and we anticipate receiving coverage in 2020. Two as you can see we have a lot of exciting opportunities. We've made a lot of progress in kidney and we're now expanding to other organs. We've been hard at work in developing very strong date.
And now we have in some cases, the largest prospective datasets available we're innovating and we're launching improvements such as prosper with quantification, we're seeing exceptional auc's I think we're in an excellent position long term to compete very well in the Oregon health space.
I'm going to hand, it over to Solomon in a minute to walk through all the recent news on signature, but first I want to spend a moment describing the effort we have underway in early cancer detection.
Our strategy here is to pursue a capital efficient development program that does not distract from the work, we're doing with Cigna Terra, but instead leverages. The technology, we're already developing along with the data we are generating with our growing base of clinical invoice volumes in oncology.
The last item is critical because we run it upfront exome on every signatures sample, we're accumulating a dataset of tens of thousands of early stage cancer exon that has never existed before we can know interrogating that data set to assist in the design of a DNA based signature that maximizes test performance. We've already completed the initial design of the <unk>.
Rectal cancer early screening DNA component now, we're excited to validate and expand on that effort with our new partnership with our House University.
And the partnership with <unk>, we secured access to a biobank of 40000 colorectal screening samples prospectively collected it would match outcome data outcomes data with it has the effect of examples or stage, one or two cancers. We've also secured an exclusive option to license the IP and access to a methylation cigna.
From our house, which demonstrated strong.
A potential in a recently published study.
Methylation signature alone reported average sensitivity of 85% with the specificity of 99% across stage one through four colorectal cancers. The performance was also very strong in early stage cancers with 80% sensitivity in stage, one and 85% sensitivity in stage two cancers.
We will of course need to replicate these results and we also believe we can improve upon the methylation signature by incorporating it into our own unique methylation workflow in adding in our DNA technology.
We'll start off with the colorectal assay and then have the potential to add additional cancer types in the future. So while we continue to build on our lead with signature and M. D. We've got a targeted program running in this adjacent and very large market I look forward to providing periodic updates on our progress here in the future.
With that let me now hand, it over to Solomon to cover the other oncology updates Solomon.
Thanks, Steve.
We've highlighted this arm of the study on the slide because we believe it can eliminate unnecessary treatment for the majority of patients right now adjuvant chemotherapy is standard for all stage three and high risk stage two patients even though we know that most patients are already cured by surgery alone and will not benefit from the chemotherapy Japanese.
The Japanese group May be able to report preliminary results from this deescalation arm in the next year and we think those results plus the data from the U S will be enough to impact M. C C and guidelines and could make it very unlikely that a study like this would ever be right again.
I think this really highlights our competitive advantage as we've developed a multiyear lead and prospective clinical data and we think winning this trial is going to significantly extend that leadership position.
Okay excited to get into a little more detail now on the news velocity data that Steve touched on earlier in his opening comments in early October we published a perspective study with 168 stage three colorectal cancer patients with a total of just over 1200 blood samples analyzed.
First of all the study recapitulated, our strong test performance in early stage CRC that we publish before this time with a nice homogeneous population of stage three colorectal cancer.
E S P.
For our products stepped up modestly again in Q3 as we continued to add some wins from additional an I T. T coverage. We also benefited from roughly 5 million in revenue from cash collections from prior periods, which is historically is more than one to 2 million dollar range, but can be lumpy as we've discussed in the past I call that I can give you some <unk>.
Contact for the revenue guide for the rest of the year, which implies significant sequential organic growth in queue for.
We also got a bump in our realized collections per unit for Sydney Tara from the D. O T pricing going into effect in Q3, we think that a D. O T will continue to help gross and a pair of S. P. As as more and more patients that started with an interior the sheer moved to the recurrence monitoring setting which is covered by the ADL T pricing.
Overall, though we chosen to let it sit in Terre a S. P b much lower than they otherwise could be because we're taking in growing volumes from a range of indications that are not yet reimbursed secret terror adoption across cancer types has exceeded our expectations, so far which is tough on gross margins any.
Immediate term, but we think is a very bullish sign for the longer term potential of this market.
You can see we improved gross margins meaningfully year over year, but still a gross margin for this quarter and for the rest of the year reflects this investment if you will and test volume ahead of reimbursement, particularly for thinking of terror and that's been balance out by strong and growing gross margins for R. N I P T and horizon products that are now well above the.
Blended average at two that point Cogs per unit in the quarter. We're on track as an I P. T. Cogs remained in 150 range in the password using cause over time remains intact, but we still have a roadmap in place to meaningfully reduced didn't care at Cox per unit overtime as we've discussed in the past.
As we covered on our queue to call. The R. N D N S T and a line also reflect the significant upfront investment we are making an oncology and research and development. We are adding staff to execute on scaling the lab along with the pull some slate of clinical trial work, we are doing with academic and farmer partners. We've said before that we.
Are not planning to hit back with our current product offerings with version one point O a cigarette tear it apart spera and I think the update Stephen Solomon provided make clear how quickly we can turn opex investments into differentiating new features <unk> terror and prosperity. In addition to the entirely new product launches Steve covered.
Open. Please go ahead.
Hey, guys good evening.
Steve one for you on on the <unk> Biobank sample project can you share some color on timelines for.
The launch and completion of your validation study and at what point do you expect to launch a prospective trial and launch commercially and then I have a quick follow up on the guide.
Yes. Thanks for the question. So we're really excited about this partnership.
The methylation data that they published looks very strong.
The biobank, obviously is very significant so we were very pleased to get access to this we hope to generate some combined data on the performance of DNA and the.
Sort of version two of the methylation platform in 2022.
Two four I think tells you that all the trends that we're seeing here in Q3 are looking really stable. It's not really you know not a one time benefit or anything like that and so we were able to blow right through any concerns related to the Delta variant and you can see in our Q3 performance so maybe that affected.
This but you just can't tell that in the numbers. So we're feeling great about you know the trajectory that we're on.
Thank you and our next question comes from the line at Tech or Peterson with J P. Morgan here in my neck Open. Please go ahead.
Hey, Thanks, and congrats on over <unk> on a cross spera frustrated with quiet quiet application is that an incremental pricing opportunity or is that more about capturing market share and then secondly, spare obviously your competitors gotten in a fair amount of trouble I'm just curious if there's pull back and how do you think about that in order to that directory too for you guys.
And then I had one follow up on the screen after that.
Yeah. So the prospera quantification technique is you know obviously something that you need to the terrorists performing exceptionally well. We've designed this in a way that we really don't have to do any additional workflow and so although I think we could go you know try to kick.
Price, we made the decision to just pass this through as a benefit to patients uhm and two physicians without increasing the price in any way, but it's it's an exceptionally streamline workflow where we've we've leveraged some novel.
Microbiology and novel bioinformatics techniques to be able to provide this without really increasing our Cogs you know with regards to some of the challenges with the competitive landscape. We don't think that there's any blow back to the terror you.
You know I think we're in a very good position.
And we look forward to competing heart.
And then I think there was one that just one last one there go.
Go ahead, yeah screaming I was just curious how you're thinking about kind of the multi cancer opportunity I mean, obviously, it's great you've got about 40000 temperature colorectal but.
As we think about additional cancer indications any rough sensitive that timeline will just be over the next year or two or how do you think about multi cancer.
The significant amount of information that we have coming from all the tumor axons that we've run and we use that to build a proprietary DNA only.
Ah aspect of the test now we're combining that with this mess methylation signature that we gained access to through the partnership with our house that is performing very well plus some internal discovery work and methylation workflow work that we're doing it in the tariffs. So we plan on putting those two things together generating some.
Proof of concept data.
In early 'twenty, two and then running 40000 sample.
Biobank.
Thereafter, our hope is that that 40000 biobank.
Itself is enough for us to get approval from the FDA for the test we don't know if that's the case, we haven't yet gone and spoken with the FDA when it's very likely that it wont in fact be sufficient to get approval, but that's what we hope and if that turns out to be the case that would be a massive win for us.
Because we Wouldnt then subsequently have to do the prospective study.
I think we plan on having that conversation with the FDA sooner rather than later so we can understand if we do have to do a prospective trial, we can start planning for that.
Executing on that.
Now in colorectal alone we think the trial.
You can look around it.
Trials are taken liking that kind of three year range.
Now.
That's okay, because we don't have to be the first test on the market.
I think this is such a huge opportunity.
It's not necessarily just about being the first one on the market, it's about doing it right and having the right test having the right customer experience have been the right performance. So if we see in the proof of concept and the subsequent validation data that we really have something here that we think is going to be a winter, we're not going to hesitate to pull the trigger.
In that perspective trial.
As far as the much broader expansion too.
To Pan cancer.
We're gonna have to we're going to have to get through some of these phase gates and hit some of these milestones before we can really talk about the timeline for doing a prospective study of that size.
Got it Super helpful. And then on Cigna, Tara I, just wanted to get a sense of.
The sort of the catalyst path ahead.
Events that we ought to be watching out for in terms of the datasets and Readouts for Cigna tariff. We obviously saw your data on if you will and a number of other datasets. So there is momentum here, but it sort of in terms of thinking of larger indications more impactful studies, just if you could just walk us.
Through.
What are some of the things to watch out for in potential conferences, where we should be expecting.
They have more data readouts around second terra that are meaningful.
Sure.
People had seen previously in a conference multiple myeloma and then we have we're looking at a pretty exciting slate of abstract to send to a C. R as well, which will be in the spring and you know I think it's a little early to say exactly to what extent you know how we're gonna use the.
Is for two to extend our reimbursement pathway. So how those discussions with Medicare and with our other pairs, but there's a lot to look forward to here.
Got it Super helpful and last one if I could just squeeze in in terms of a D. L. T reimbursement was there any contribution in the corner and I apologize if I missed that.
Yeah great.
Yeah, I'll take it yet so we did get a modest bump in the quarter from the D. O T pricing and I think that's something that can be it can can you tailwind for signal Clara clinical volumes in these gonna reimbursed cancers.
Take really I, you get more and more patients that I've started cleaning up there. We'll go through that first that's six months kind of argument window and then they <unk> flipping through the recurrent monitoring indication Bobby indication that's reimbursed under the a D. O T. So as you can build a bigger base of patients that have have kind of gone through that for six.
The mix of your volume is gonna shift toward that <unk> monitoring indication that will tend to be <unk>, but we did start to see a little bit of that in Q3.
Okay Super helpful. Thanks, guys.
Thank you and our next question comes from the line of Catherine shops, but they aren't Carolina. Adult then please go ahead.
Hey, guys. Thanks for the questions, Yes, first for Signet Tara I believe Hitler waiting on the I L. R umbrella O C D to be finalized and then you could submit data pockets for other indications to amend the billing article is that still your plan and if so what are the indications that you kind of have you know ready to go once we have a.
Final all C D. And then obviously Medicare is running behind schedule here have you heard anything from them in terms of timing.
Okay, well, let's reimburse you know the commercialization part is easy and you know that's something that we do exceptionally well. So I think we'll we'll have to you know we'll have to deal with that when the time comes but our women's he'll channel I think is an exceptional channel for commercialization.
You are now broadly covering the vast majority of women's health providers is and as you know you know many women I use their their obgyn or G y N as as their primary care provider, but yeah lots of opportunities for commercialization and we'll cross that bridge in the future.
Okay, great. Thanks.
Thank you and our next question comes from the line of Max Mr. <unk>.
Counting your line is open. Please go ahead.
Hi, Congrats on a great update across the board.
600 dollar range for micro deletions as a standalone product. So it's a lot of volume that that we run a lot of results. We returned to patients and then submit for reimbursement with the with the.
Constructive contracted rate and then as you alluded to you with the fresh the time, we get paid is quite low so I'm yeah, yeah per cent paid rates on micro dolls, and that kind of single digit percentage kind of range and so the resulting in a S. P S or if there's only a few bucks out of the S. P that can change really meaningfully when we can get the publication out.
On the smart data that we talked about earlier this year and if we can use that data to to see some guideline revisions in favor microbism testing. So I can get somebody that we're very excited about seeing more developments on going into 2022.
Makes sense thanks, guys.
Thank you and our next question comes from the line kind of likes in Iraq with Craig Hallum Capital Group. Your mind is open. Please go ahead.
Okay.
And if you take that penetration benefits still go on prenatal seem to terror still Miss very early phase of launches in a single cancer and and then the big efforts you are making here and transplant how're you thinking about growth going into 2022.
Yeah, well I mean, obviously, there's a lot of stuff going on.
Continuing to execute well across the business lots of exciting momentum and transplant you know as we announce today you know a lot of exciting momentum I'm thinking of terror.
You know very very long way to go in N. I P. T. So there's a lot of excitement like you want a constant comment specifically on sort of how we're thinking about forecasting or or you know what we're thinking about <unk> for 22.
Yeah, I mean, I I think that the trend that you saw in Q3, we think are pretty stable trance see that through the guide that we have out there now for the for the full year and we got a couple of pretty important product launches going with the nuclear and prosperity and there's a lot for us to learn as we go through the next quarter.
So on those launches so I I mean, I can to pay providing a guy for 22 on kind of a typical timeline will give them an updated J P. J P. Morgan conference and they will likely returned with a formal got in queue for but you know all these kind of trends you can kind of see them you know Q2 and cute three has been.
I have been pretty stable and quiet disruptive.
Yeah, just simply not true.
There's a very small portion of our.
The business that we're doing that's part of our registry trial.
And the remainder is commercial testing.
Yeah, and I'll pick up on the just on the breaking out of the.
The different products.
I think for us it's a it's a matter of.
Just getting to learn.
How these products perform quarter to quarter and what the right trends are what the right growth trends are so that we can feel great that we're accurately forecasting them and being able to share those with you guys.
How these products perform quarter to quarter and what the right trends are what the right growth trends are so that we can feel great that we're accurately forecasting them and being able to share those with you guys.
Similar to my comment on the last question is that we currently still have a lot to learn with these products I mean, I think in a lot of ways Q3.
It's really the first full quarter, where we had.
Teams in place and they had been in place long enough to kind of know which ended up in and have a have a lock territory.
And be able to beat it.
Be able to be productive.
And so it's not long.
Until we will be able to give more detail and give more guidance on it but we're at the time at the moment.
Learning and still watching the launch has happened.
Awesome and then if I can sneak one last one and congrats on the 40000 samples from the University in Europe, I guess can you speak to.
Why do you why you decided to.
Pursue that option as opposed to something else.
I'm just curious.
I believe the university's based in Denmark can you speak to.
The homogeneity.
How much in any of the heterogeneity of the samples and whether or not you think that the sample types would be rich enough for U S equivalents.
Questions about.
When we go for a pre submission meeting with the FDA on among other things I mean as.
As I said before.
This probably.
May not end up being the end all be all set that we need to get the test.
Reimbursed, we hope it will be and we think we have a good case when we go make a pre submission meeting, but you know ultimately.
Ultimately, we might end up having to do a prospective trial now if the test performs as we expect it to and we continue to believe the market opportunities as big as are we.
Thank and others thinking is we will not hesitate to pull the trigger and run that trial, even if we're not going to be the first to market, which we don't think matters. If you look at MIP T. We were the fourth to market multi.
Multiple years after others and now we have 40% share.
So you want to have the best test you wont have the best distribution the best customer experience and you don't have to be first to market to deliver that.
Great Congrats guys.
Thank you and that concludes today's question and answer session.
So ladies and gentlemen, this does conclude today's conference call. Thank you for participating you may now disconnect everyone have a great day.
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