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spk00: The conference will begin shortly. To raise your hand during Q&A, you can dial star 11. The conference will begin shortly. To raise your hand during Q&A, you can dial star 1 1.
spk02: Good day and thank you for standing by. Welcome to the Verisight's third quarter 2022 financial results conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Shayla Gorman, Director of Investor Relations. Please go ahead.
spk11: Good afternoon, everyone, and thanks for joining us today for a discussion of our third quarter 2022 financial results. With me today are Mark Stapley, Verisight's Chief Executive Officer, Rebecca Chambers, our Chief Financial Officer, Dr. Tina Nova, President of our U.S. CLIA business, and Dr. Julia Kennedy, Global Chief Scientific Officer and Chief Medical Officer. Verisight issued a press release earlier this afternoon detailing our third quarter 2022 financial results. This news release, along with a business and financial presentation, is available in the investor relations section of our website at Verisight.com. Before we begin, I'd like to remind you that various statements that we may make during this call will include forward-looking statements as defined under applicable securities laws. Forward-looking statements are subject to risks and uncertainties, and the company can give no assurance they will prove to be correct. Further, we are not under any obligation to provide further updates on our business trends or our performance during the quarter. To better understand the risks and uncertainties that could cause actual results to differ, we refer you to the documents that Verisight files with the Securities and Exchange Commission, including Verisight's most recent Forms 10-Q and 10-K. In addition, this call will include certain non-GAAP financial measures. Reconciliation of these measures to the most directly comparable GAAP financial measures are included in today's earnings release, accessible from the IR section of Verisight's website. I will now turn the call over to Mark Stapley, Verisight's CEO.
spk07: Thanks, Shayla, and thanks, everyone, for joining us today. Our third quarter was incredibly strong in all respects, and we delivered growth of 25% year-over-year achieving revenue of $75.6 million. With outstanding execution by our team, we continue to realize the potential of our highly valuable CLEAR tests while also advancing our long-term growth opportunities and strategic vision. Our testing business, which represents over 85% of our revenue, grew 27% this quarter, exceeding our expectations. The seasonality we are used to seeing in the third quarter did not play out as anticipated, and traction in our core urology and endocrinology markets strengthened. We reported over 11,000 deciphered prostate tests in the quarter, up double digits sequentially. Our investment in our world-class commercial team, coupled with a continuous cycle of clinical evidence resulting in broader reimbursement coverage and guideline expansion, is paying off. We believe that we now have clear majority share in a market that is just over 25% penetrated. With the broadest indication coverage of any test and positive guidelines for many of those indications, we continue to have strong conviction that most men with prostate cancer should be receiving Decipher testing. We have a proven track record of executing a well-understood playback of evidence development fueling market penetration, which will enable us to achieve durable growth for Decipher for many years to come. To this point, during the quarter, key data were released from the Phase III Multicenter Multinational Stampede Trial. These findings suggest that Decipher Prostate may potentially be used to help inform decision-making regarding intensification of therapy in men with advanced prostate cancer. This adds to the body of evidence that we will use to expand reimbursement coverage of the Decipher Prostate test into the metastatic indication, making the test commercially available to even more patients diagnosed with prostate cancer on top of the over 90% that the test is indicated for currently. Additionally, a study was published in the Journal of the National Cancer Institute, and data were presented on a genomic signature derived from the Decipher grid database at the American Society for Radiation Oncology annual meeting. With close to 70 publications and many more podium presentations, the clinical evidence supporting the Decipher test is unparalleled. This strong body of evidence has led to enhanced guideline inclusion and commercial payer coverage. Last quarter, the National Comprehensive Cancer Network, or NCCN, further updated its prostate cancer guidelines, making Decipher the first and only gene expression test to achieve level one evidence status in prostate cancer. Further, over the last several quarters, our experienced managed care team has been utilizing the new evidence and guideline inclusion to drive and expand reimbursement for the Decipher prostate test. We recently received positive coverage decisions from three major commercial payers, representing over 20 million members, bringing the total number of covered lives for the test to 195 million. Affirma, a market-defining test for thyroid cancer, had its strongest quarter so far this year, with revenue growth of 6% compared to the prior year period. We launched Affirma 11 years ago into a market that, at the time, was not using any genomic tests to help determine whether to carry out surgery on patients who presented with an indeterminate thyroid nodule. Again, through a cycle of evidence development, KOL support, guideline inclusion, and reimbursement, we defined a market that is now, we believe, over 50% penetrated with room to grow further. Thanks to our talented commercial team, Affirma continues to be our leading test in terms of patient results delivered during the quarter, and we believe it continues to be the market-leading genomic test in thyroid cancer. We added more than 65 new Affirma accounts this quarter and saw an increase in the number of tests ordered per account. We also experienced continued payer traction, adding four payer contracts with large regional plans, enabling Affirma to be an in-network offering for over 10 million additional health plan members, bringing the total to more than 230 million lives. Additionally, we launched a new online portal for our Affirma customers, providing a convenient way for physicians and their staff to track patient samples, view test results, order supplies, and in the near future, order tests online. This product enhancement, the first of a number that we plan to launch, will enhance ease of use for our customers, accelerate the time to patient results, and increase our internal efficiencies. Finally, we were excited to share new research at the American Thyroid Association Conference, which demonstrated our ability to uncover new thyroid cancer insights by drawing upon our extensive database and our whole transcriptome capabilities. Ultimately, we believed that such insights could help fuel the next phase of innovation in thyroid cancer care and further differentiate a firmer. All of these accomplishments give us confidence that Affirma will continue to deliver meaningful revenue growth in the mid to high single digits in 2023. Moving to our biopharma business, we continue to pioneer new frontiers in immuno-oncology, which we believe will help our biopharmaceutical partners advance cutting-edge treatments such as CAR-T cell therapies, immune checkpoint inhibitors, and others. For example, this quarter, an exciting study published in Nature Medicine suggested that our proprietary technology could help distinguish patients with large B-cell lymphoma who will benefit from CAR-T cell therapy. This is the first paper to make this connection between predefined immune biomarkers and response to such therapy among these patients. These findings provide an important proof point for how our multi-omics expertise and offerings can benefit our biopharma partners. Looking forward, We believe our broad portfolio and proven approach to evidence generation, reimbursement, and official commercial deployment gives us numerous opportunities to transform patient care and drive revenue growth. At the same time, with multiple early-stage products of various phases of developmental commercialization and with our strong sense of As a reminder, Our investments in our long-term growth opportunities are primarily focused on the aforementioned perceptor nasal swab test in lung cancer, as well as the development of in vitro diagnostics or ABD versions of the Invisia, Decipher, and nasal swab tests for the NCANA instrument. The Nightingale clinical utility study for our perceptor nasal swab test is progressing well, with enrollment plans for completion at the end of next year. We shared preliminary data from Nightingale and the CHESS annual meeting last month, suggesting that our test classifies more patients as low-risk for lung cancer so they can potentially avoid unnecessary procedures, and more patients as high-risk so they can proceed to more timely diagnosis and treatment, if necessary, as compared to standard of care. On the global launch of our test menu, all three of our IBD product development programs are on track, and we are looking forward to submitting the first of those, our Invisiogenomic Classifier, for EU regulatory approval in 2023. We are encouraged by the compelling data that were presented at the European Respiratory Society Annual Conference, further building awareness of the Invisia test among clinicians in Europe. In summary, we had a great quarter in which our team executed to deliver strong results on our current business and made important, tangible strides towards achieving our long-term strategic vision. We will continue to focus on driving improved outcomes for patients via our exceptional diagnostic tests and in turn driving growth and future profitability for VeriSight. With that, I will now turn the call over to Rebecca to discuss our financial results in more detail.
spk09: Thanks, Mark. As Mark said, we had another stellar quarter with $75.6 million in revenue, an increase of 25% over the prior year. We grew total volume to over 26,000 tests, a 26% increase over the same period in 2021, and despite expectations of typical summer seasonality, a 6% increase sequentially. We delivered testing revenue of $64.6 million, an increase of 27% year-over-year, driven by higher-than-expected deciphered prostate and affirma volume, with last quarter's affirma supply chain situation now in the rearview mirror. Testing ASP was up slightly sequentially on volume of approximately 24,000 tests, driven primarily by mix, as well as improved payer contracting across our Affirma and Decipher tests. Third quarter product volume was approximately 2,400 tests, resulting in revenue of $3.3 million, up 12% year-over-year despite a currency headwind of over 10% given prior year rates. Biopharmaceutical and other revenue totaled $7.7 million. ahead of expectations with seasonality having a smaller impact than anticipated. The biopharmaceutical business usually contributes about half of the revenue in this line, with IVD services and manufacturing making up the remainder, and this quarter was no different. Moving to gross margin and operating expenses, I will highlight non-GAAP results which exclude the amortization of acquired intangible assets, other acquisition-related expenses, and restructuring costs, but does include routine stock-based compensation. Non-GAAP gross margin was 66%, approximately flat sequentially. Testing gross margin was 69%, up 40 basis points compared to the prior quarter. Product gross margin was lower, 7% sequentially. Importantly, we've made great progress on our manufacturing transfer as we're now fulfilling Prosigna kits out of France ahead of our year-end goal. As with any transition like this, we saw some incremental costs as we stood up the process, which led to the lower product gross margins. Biopharmaceutical and other gross margin was lower due to product mix shift. Non-GAAP operating expenses, excluding the cost of revenue, increased by $2.1 million sequentially to $51.1 million, driven by ramping clinical trial and project expenses, as well as higher commission expense given our revenue outperformance. Research and development expense increased by $1.4 million to $10.5 million. Sales and marketing expenses grew $1.2 million to $24.3 million. And G&A expenses were down half a million dollars to $16.3 million. We recorded a gap net loss of $8.7 million, which included $7.4 million of stock-based compensation. We increased our overall cash position by approximately $6 million and ended the quarter with approximately $170 million of cash, cash equivalents, and short-term investments. Turning to our updated 2022 guidance, we are raising our full-year revenue expectations to $288 million to $293 million, or 31% to 33% growth versus the prior year on a reported basis. This range, compared to our previous guidance of $272 million to $280 million, reflects our strong performance in the third quarter, continued outperformance of our urology business, a FIRMA full-year revenue growth of low to mid-single digits, and current currency rates. We expect BioPharma and other revenue to be down sequentially given project timing. As we've said previously, we believe we have plenty of cash on hand to take the business to profitability barring M&A. In 2023, we anticipate we will be able to continue to invest in our long-term growth drivers and remain approximately cash flow neutral, excluding the impact of prior acquisition-related contingent consideration expense. I will now turn the call back to Shayla.
spk11: Thank you, Rebecca. We'll now go into the Q&A portion of the call, and Tina Nova, president of our U.S. CLIA business, and Julia Kennedy, global chief scientific officer and chief medical officer, will join us. Operator, please open the line.
spk02: Thank you. And as a reminder, to ask a question, you will need to press star 11 on your telephone. Please stand by while we compile the Q&A roster. One moment for our first question that comes from Mason Carrico with Stephens. Please proceed.
spk01: Hey, guys. This is Jacob Bond for Mason. Thanks for taking the questions. Maybe just starting with Affirma and maybe a cleanup here. Was there a carryover of vendor-related issues from that 2Q vendor-related impact on Affirma volumes during the quarter? Or was it more or less back to business as usual throughout the entirety of the quarter?
spk07: Yeah, I would say, and as Rebecca mentioned, that's very much in the rearview mirror for us now. And we think the positive effect, if you like, of that in the third quarter was very muted, very small. Most of the issues that affected us in the second quarter were dealt with in that quarter, and we were able to get back to normal. And that activity with that vendor has been back to normal during the bulk of the third quarter as well. So very much behind us.
spk09: And just as a reminder, the third quarter of last year did see a decently large impact for Afirma by Omicron. So that is just something to keep in the back of your mind as well.
spk01: Okay, got it. Awesome. So then moving on to your biopharma business, you all have recently been talking a lot about the immuno-oncology opportunity and the high demand you're seeing from biopharma. If possible, could you provide some color on just the size of the business currently maybe just run rating the contribution from this business. And then what are your expectations for the ramp and potential scale of this business over the long term, maybe, say, next three years or so?
spk07: Yeah, maybe I'll start, and then, Rebecca, you might want to jump in with some of the quantification. But we're really excited about the immuno-oncology business in particular and how our biopharma team supports customers in that business and partners. You know, we've had a number of really interesting publications over the last several quarters, including with Immunoscore IC in colon and lung cancer, and more recently with a great Nature publication in CAR T-cell, as I mentioned earlier. And so, you know, the number of assays we have, both kind of proprietary ones that we've developed as well as the custom ones that we can develop on demand, for our customers, I think really demonstrates for them an opportunity with VeriSight to advance their clinical trial programs, to help identify biomarkers, and ultimately at some point drive towards companion diagnostic development. In terms of the revenue numbers, Rebecca?
spk09: Yeah, I'd be happy to take that portion. So you can explicitly see the BioPharm and other revenue line in the face of our P&L. Approximately half of that revenue line is the biopharma portion. The other piece is the IBD contract development and manufacturing, about 50-50. Two very different growth dynamics across the two portions of that business purposely. The biopharma piece is growing very nicely. That should be accretive to total company growth. On the contract IBD and manufacturing piece of that revenue line, That is not necessarily a growth factor for the organization very purposely. The reason for it is effectively we use those same resources for our own IVD development and manufacturing and as we move towards more and more of that, that is going to become less of a meaningful contributor to revenue over time. So it's a bit of a tale of two businesses, if you will, with obviously the more strategic asset from a revenue perspective being the biopharma asset and the contract development piece being very important for our R&D efforts and IVB strategy specific to VeriSight.
spk07: Maybe one thing I'll add just on the biopharma side, agreeing with everything Rebecca said, The revenue itself, due to the nature of those contracts and the timing of milestones, can be very lumpy quarter by quarter, just to bear that in mind as well.
spk09: Absolutely. And we think about that growth being accretive on an annual basis more so than a quarterly basis.
spk01: Okay, got it. Appreciate the color, guys. I'll hop back in the queue. Thanks.
spk07: Thank you.
spk02: Thank you. One moment for our next question. That comes from the line of Andrew Brackman with William Blair. Please proceed.
spk04: Hey, guys. Good afternoon. This is Griffin on for Andrew. Thank you for the questions. Maybe just on the guide here, so beat by about 9.2 versus consensus, raised about 14.5 with most of that beat in the quarter from Decipher. You talked about large numbers. I think there was a competitor yesterday that had like mid-teens growth in the competing tests versus something pretty close to 50% for Decipher. Can you just talk about how you think about the durability of prostate longer term, maybe next year? I think that's just a big question we get.
spk07: Yeah, maybe a couple thoughts on that. By the way, firstly, just so you know, the beat was driven also by, from our standpoint, the Affirma product as well. Affirma had a record quarter in terms of volume, and I'm extremely proud of what that team's been able to accomplish and how that product continues to grow. The market's over 50% penetrated, and we keep demonstrating an ability to both bring on new customers and also increase the volume at existing customers, both of which are driving upside in volume. And then, of course, we're working on the ASP, as we've talked about before. On Decipher, kind of a similar story, but an earlier stage story. Decipher is in a market that is about just over 25% penetrated, also represents the majority share. And we've clearly been able to demonstrate through that playbook of evidence development and guideline inclusion, including the NCCN Level 1 guidelines, and it's the only genomic expression test that does that, that has that Level 1 guideline. We just keep driving, you know, more and more market adoption of Decipher. I'm going to turn to Tina to add any color commentary she wants to. I mean, she's driving this business with her team and doing an exceptional job of doing so.
spk10: No, thank you. It's a great question. And I think if you compare Decipher to Affirma, as Mark just mentioned, Affirma's been on the market for many years, but continues to gain new customers and continues to do very well. And if you compare that to Prostate, you would think that on a direct comparison, you would say that Prostate is more like year three in its development, because by the time we had coverage for all the different biopsies and for RP. That was just a few years ago. So we really believe we have a lot of runway. We're still gaining a lot of new physicians every year. We continue to develop on the clinical utility side. We're doing presentations at all the major meetings and not only posters, but also podium presentations by others. And the level one evidence that just came out is really
spk07: incredible validation of the product yeah and as I think I've said before you know I don't I don't see this situation changing for the foreseeable future here I mean we've got a lot of a lot more room a lot of headroom in the market for decipher as I said you know in the prepared remarks here we're at the point where most every man with prostate cancer should be getting a decisive test there's very few indications left that we need to we need to get included so I Plenty of opportunity for ongoing growth in the future.
spk04: Okay. And then on Affirma, just following up on that, so you've reiterated the mid-to-high single-digit 23 growth. Just from a price and volume assumption, can you just maybe quantify the benefit you expect next year following the depressed Affirma ASPs that we saw in the second half with that CPT code change?
spk09: Yeah, so good question, Griff. And I think that's probably parsing it a little bit more than we're ready to do so here. I think you absolutely identified that ASP should be a tailwind. With volume growth that we're seeing, that also should be a tailwind. The puts and takes in any given quarter aren't necessarily something we want to get in the habit of guiding to, just because that's highly dependent on a number of different variables. The most important thing to know is we are very confident in the mid to high single-digit growth in 2023 for Afirma. ASP will no longer be a headwind. It should be a tailwind. And in volume growth, there's plenty of room left in the market to get to penetration levels that support incremental volume growth.
spk04: Okay. If I could just sneak one more in, the $7 million operating cash flow is pretty unique in small-cap diagnostics land. How do you think about just the M&A appetite? What kind of assets are most appealing right now? Anything on that front?
spk07: Yeah, so firstly, I mean, obviously very proud of our team in terms of delivering that strong cash generation in the quarter, and obviously ending the quarter with $170 million of cash up from last quarter is fantastic. In terms of M&A, our situation, our position there hasn't changed. We've always said we're open to M&A, and we never ignore opportunities that presented themselves to us. But the bar is very high, and it's not our primary focus right now. Our primary focus is growing our business, and continuing to execute on what we're doing here, including near-term and long-term drivers. But given we are very focused on cash and a clear path to profitability, we'd only be interested in significant assets that were at an inflection point, where they would be accretive in some way to our growth rate and our cash position. Small technology bolt-on type of things would also be possible, but I'm talking about anything of significance here. So, you know, no change in our approach there. I will say that, you know, we're now, what are we, over a year into our integrations of Decipher and Helio DX. And, you know, given our team's experience that we've developed over that year and prior, we'd be very successful at absorbing acquisitions if we did decide to do them. So, you know, some good experiences there. But like I said at the beginning, more kind of, you know, on the watch rather than trying to drive anything at this point.
spk05: Okay, excellent.
spk02: Thank you. One moment for our next question. And it comes from the line of Mike Mattson with Needham & Company. Please proceed.
spk08: Yeah, thanks for taking my questions, and congrats on the solid quarter. I guess first I wanted to ask about operating expenses. it looks like it grew significantly slower than revenue. And first time I can remember seeing that, so in a while at least. So is that something that you can sustain now, you know, driving leverage, just growing FX? I know you've done some acquisitions and stuff, so that probably was why it was growing a bit faster before.
spk07: Yeah, I mean, I'll start and then Rebecca jump in. But we're very, as you know, we're very focused, Rebecca and I and the whole team on, cash generation, fiscal responsibility, using our operating expenses in the most effective way for the greatest return, both near-term and long-term. And so I'm happy to have mentioned and talked about the portfolio review work that we went through that culminated recently. And we've been doing that for over a year. This isn't a reactionary thing. It's actually just good management. We will continue to do it going forward. but as far as where we are today, we've made all the decisions we need to make, and so the investment level that we're making right now and into next year reflects the effect of all of those prudent decisions. Rebecca?
spk09: Yeah, absolutely, and I completely agree. I think when we look going forward, there are, line by line, a couple of different factors. On the R&D side, obviously, Nightingale is a critical priority for us and as that is that enrollment continues to ramp you will see expense ramping but over time absolutely believe R&D should be a point of leverage on sales and marketing we have a very unique structure in that what our specialty sales teams serving the urology endocrinology and pulmonology markets actually are incredibly productive given we can serve those markets worth anywhere from 40 to 50 people. And therefore, sales and marketing has been an extreme point of leverage for this organization and will continue to be one on a go-forward basis, especially with some of the decisions recently made around the pulmonology portfolio. On GNA, absolutely, should also be a point of leverage on a go-forward basis, especially x.com. So I think you hit the nail on the head when we look about what our investment areas are in 2020. And, you know, we've highlighted those all to you all at this point in time. So, you know, not saying there'll be 100% drop-down margins or incremental margins. That obviously wouldn't be prudent, but you should definitely see incremental margins on a go-forward basis out of OPEX.
spk08: Okay, thanks. And then just one on encounter, and I know this probably isn't new in terms of, like, the order or the sequencing of the tests, the IVD tests that you're planning to launch in Europe, but I guess why is Invisia the first one? I mean, just given the kind of home run success of Decipher's test, I mean, why wouldn't you go with Decipher first?
spk07: It's an excellent question. You can imagine one we pondered a lot when we first, you know, started to look at this. And the reason is quite simple. Invisia was very far advanced already in terms of, you know, before we acquired Decipher. in terms of advancing the code set and getting the test ready and validating it and being able to demonstrate conformity with our existing lab-developed tests. So it is a perfect illustration of the model of complex, clear-based tests and then being able to move that over to the encounter. And it was so far along on that journey that it's just a case of getting it ready and submitting it. Decipher prostate needed to go back several steps to be commenced from the beginning forward, right? We had to start that work at the very beginning that we'd already done on Invisio. So we looked at this well over a year ago, just as we completed the Helio acquisition, and the team came forward with what I thought was an extremely smart and responsible approach of launching Invisio first, use that to prove, you know, get our team to demonstrate, you know, the capabilities there. And then Decipher came next because, for the very reason you mentioned, there is a big market for prostate testing and an unmet need over there and a pent-up demand, we believe. So that's why that's the next one on the docket. And then, of course, NasalSwap the year after that.
spk08: And with just Invisia, I mean, do you think that there's a big enough market there that you could drive kind of encounter placements with that alone? Are you going to need kind of a broader menu before it really starts scaling up?
spk07: You need more. I mean, if you think about insufficial lung disease, you know, an IPF, it's a rare condition. And so, you know, it helps to have that additional test on the menu for sure. And our European team is looking forward to having that in their portfolio to be able to sell. But it's going to need the menu and for us to, you know, at least add Decipher. I think once we add Decipher prostate, you see a kind of a step function increase in the interest going forward. And then, of course, when you lay a nasal swab on top of that, you get the next big step function.
spk09: And recall, there already is a pretty significant install base of NCounter instruments in the European market. And so, as we look forward to the growth factors of the organization over, you know, a long-term timeframe, this is much more about the actual pull-through of the kits and the reagents more so than instrument placement.
spk08: Yeah, okay, got it. Thank you.
spk02: Thank you. One moment for our next question. It comes from Tejas Savant with Morgan Stanley. Your question, please.
spk12: Hello, this is for Tejas. Thank you for taking our questions. You mentioned that you see a lot of room for growth in your prostate decipher test, but specifically on the recent shift in dynamics and prostate classifier landscape, do you see this could be a share gain opportunity for you? Do you think this could represent a temporary bump as some of the competitor tests would chance, or do you view the potential share shift as sustainable?
spk07: When you're referring to the shifting dynamics, are you talking about with respect to exact and MDX health?
spk06: Yes.
spk07: Or something different? Okay. Yeah, I mean, Tina, I'll pass that over to you. I mean, you're living this every day.
spk10: Yeah. You know, I think that, you know, we feel very good about the market that we occupy. We feel very good about the customers that we have and how we've penetrated. the market, and our test is different from that test. You know, they don't have the grid offering that we have, which really is very much used by a lot of our physicians to look at other genes in the RUO setting and think about it very differently than just the test itself. And because of our level of evidence and how far ahead we are, and again, back to that level one that just came out with the NCCN guidelines, that's very, very different than the competition where they're seeing a level three. So I still think that with our market position, even with that movement from exact to MDX, that we still have a great position in the marketplace. And I don't feel that's going to make a great difference to us.
spk05: Totally agree.
spk12: Got it. That was super helpful. And then as a separate follow-up, Could you elaborate on the trial design for the Percepta nasal swab study Nightingale, and have that enrollment for that study caught up, and how many patients are you expecting to enroll into the study by year-end, and how does that timeline for the trial readout stack up against timelines for getting that test on encounter?
spk07: Yeah, so a couple things there. In terms of the Nightingale study itself, I'm not going to give any more detail on the trial design, but You know, I reported last quarter that we're about a quarter behind in our enrollment. I'm extremely pleased so far with the progress the team's making. It's still very early days and very, you know, relatively small patient numbers so far, as you would expect, because the ramp comes as you bring on more and more sites. But the site acquisition, the site initiation is very much on track, and we're seeing an increase in the per site, you know, patient numbers as well, which is very encouraging at this stage. So it's nice to see that. I think it'll be a couple more quarters before we start to see those numbers get to where it really demonstrates how far along we are. We do still expect, based on the work that we're doing and the projections that we've done, that we can meet our own internal guideline of getting that done by the end of next quarter, end of next year, I'm sorry, end of 2023, in terms of the final patient enrollment. Now, relative to the encounter implementation, Again, this goes back to our model and our strategy. Having these tests launched in the U.S., reimbursed in the U.S., and so on, certainly helps with our OUS market. But at the same time, we're looking at ways that we can generate even more evidence development and show clinical utility with our partners outside the U.S. And so nothing at this stage yet, but that's something that we're going to be looking at. John Light just joined us as a GM of our pulmonology business, and that's one thing he's going to be thinking about. is the OUS market. But I would tend to, you know, at this stage I would think about it as being a typical model of you launch the test in the U.S. and then, you know, the OUS reimbursement comes after that.
spk12: Got it. That's super helpful to color. Thank you.
spk02: Thank you. One moment for our next question, please. And it comes from the line of Matthew Sykes with Goldman Sachs. Please proceed.
spk03: Hey guys, congrats on the quarter. This is Dave on from Matt. You had some good wins on the commercial payer coverage side. Could you tell us more about how these discussions went and any expectations for future discussions going forward?
spk07: Yeah, I mean, I'll start and anyone else on the team can feel free to add in here, but the way these discussions go is typically the way they go. There's a lot of blocking and tackling and a lot of negotiation and and a lot of hard work by a very experienced team to get every one of these over the finish line. And even when you do, there are plenty that take a long time to get, and some you don't even ever get, even for tests that are as well embedded or guided or utilized as both Affirma and Decipher. So the team's done a great job just continuing the drumbeat here. We've always got more in the pipeline. It's nice to see so many covered lives now, and both of those are core testing products. Anything you want to add?
spk10: Yeah, I would just say that Decipher is still early in its progression with the commercial payers. We continue to add every quarter. We did add a few more this quarter as well. And again, as I mentioned previously, I think the addition of the Level 1 evidence by NCCN and the presentations that were done that extend our clinical utility data are very, very helpful. and securing these contracts.
spk03: Great. And then on the manufacturing transition to Marseille, great to hear that the first wave is completed. Any additional color there around next steps, what we can look for going forward?
spk07: No, I think it was great to see the fulfillment staff completed and transitioned over to Marseille, and the team's doing a really, really nice job over there. The key part of the next stage is the actual manufacturing, and that will take through, as we mentioned before, through the end of 2023 to get done. So nothing more to report on that until we get to the end of next year, but I don't foresee any problems with that.
spk03: Great. Thanks, guys.
spk02: Thank you. And with that, I'll conclude the Q&A session, and we'll turn the call back to Mark Stapley for final remarks.
spk07: Thank you. I appreciate it. So, you know, as you just heard, we had an excellent quarter and we're on track to finish out the year strong. I'd like to thank our incredibly talented team for their hard work, execution, and deep commitment to the patients we ultimately serve. I'd also like to thank our executive chairwoman and Verisight co-founder, Bonnie Anderson, for all of her support during the last 18 months. Bonnie will continue to help us achieve our long-term goals from the vantage point of board chair as she transitions fully into that important role from January the 1st next year. So I'm really looking forward to continuing to partner with her and the board. Our high-value tests are addressing key unmet needs, as you know, delivering insights that enable physicians to provide exceptional care to their patients at moments that matter in the race to diagnose and treat cancer. We have a portfolio of great products, a winning formula for commercializing them, and a clear pathway for making them available to patients around the world. I couldn't be more excited about our progress to date and the tremendous opportunities that lie ahead for VeriSight. With that, I want to thank you for joining us today, and we look forward to keeping you apprised of our progress. Thank you.
spk02: Thank you. And ladies and gentlemen, this concludes our call for today. Thank you for joining us. You may now disconnect.
spk00: The conference will begin shortly. To raise your hand during Q&A, you can dial star 11.
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