Good afternoon, and welcome to Castle Biosciences Second Quarter 2021 Conference Call. As a reminder, today's call is being recorded. We will begin today's call with opening remarks and introductions, followed by a question-and-answer session.
I would like to turn the call over to Camilo Zucaro, Executive Director, Investor Relations and Corporate Communications. Please go ahead..
Thank you, operator. Good afternoon, everyone. Welcome to Castle Biosciences' second quarter 2021 financial results conference call. Joining me today is Castle's Founder, President and Chief Executive Officer, Derek Maetzold; and Chief Financial Officer, Frank Stokes. Information recorded on this call speaks only as of today, August 9, 2021.
Therefore, if you are listening to the replay or reading the transcript of this call, any time-sensitive information may no longer be accurate. A recording of today's call will be available on the Investor Relations page of the company's website for approximately three weeks.
Before we begin, I would like to remind you that some of the information discussed today may contain projections or other forward-looking statements regarding future events or the future financial performance of the company, including expectations and assumptions related to the impact of the COVID-19 pandemic and are made pursuant to safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
Forward-looking statements are based upon current expectations and involve inherent risks and uncertainties, and there can be no assurances that the results contemplated in these statements will be realized. A number of factors and risks could cause actual results to differ materially from those contained in these forward-looking statements.
These factors and other risks and uncertainties are described in detail in the company's Quarterly Report on Form 10-Q for the quarter ended June 30, 2021, and in the company's other documents and reports filed with the Securities and Exchange Commission.
These forward-looking statements speak only as of today, and we assume no obligation to update or revise these forward-looking statements as circumstances change. In addition, some of the information discussed today includes financial metrics such as adjusted revenue and adjusted gross margin, which are non-GAAP financial measures.
We believe these metrics provide useful supplemental information in assessing our revenue and cash flow performance.
Reconciliations of these non-GAAP financial measures to the most directly comparable GAAP financial measures are presented in the tables at the end of our earnings release issued earlier today, which has been posted on the Investor Relations page of the company's website. I will now turn the call over to Derek..
Thank you, Camilla, and good afternoon, everyone. Thank you for joining us today for Castle's second quarter 2021 earnings call. This afternoon I will discuss highlights from the quarter and recent progress against our growth initiatives. Frank will then provide additional detail on our financial results and performance.
I'd like to start today's call by thanking the Castle team. On the sales side, we're able to conduct sales trading updates in-person in the first quarter and we entered the second quarter fully engaged as our clinical - as our clinician customers continue to open up their practices.
It is our team's hard work that contributed to an exceptional quarter. And by exceptional, I mean that we had record test report volume in a single quarter for each of our proprietary gene ex profile tests. Say, differently we continue to execute on our long-term growth initiatives furthering our position as a leader in dermatologic diagnostics.
In the second quarter 2021, we delivered total revenue of $22.8 million, a 79% increase over the second quarter of 2020. Additionally, our adjusted revenue, excluding the effects of revenue adjustments related to test delivered in prior periods, was $22.9 million, a 120% increase over the second quarter of 2020.
As you may recall, we provided revenue guidance in May for the full year 2021. Due to our strong performance and expected continued momentum, we are raising our 2021 revenue guidance for the full year to $89 million to $93 million compared to our previously provided guidance of $80 million to $83 million.
We delivered 7,007 total gene expression profile reports in the second quarter 2021 compared to 3,314 in the same period of 2020. This includes 5,128 DecisionDx-Melanoma test reports delivered, despite cutaneous melanoma diagnoses remaining below historical 2019 levels by approximately 12% based upon our analysis of third-party data.
The year-over-year growth in DecisionDx-Melanoma test reports of 70% reflects gains in both diagnoses compared to 2020 as well as significant gains in market penetration. We understand that comparing test report growth to 2020 may be less informative given that we believe the pandemic impacted us the hardest during the second quarter of last year.
So, to provide a different perspective our second quarter 2021 report volume for DecisionDx-Melanoma is a 39% increase over the second quarter of 2019. And this is in the face of the ongoing decrease cutaneous melanoma diagnoses I just mentioned.
Although we cannot be certain of any potential future impacts of COVID-19 including the emergence and spread of variants, we believe the positive momentum we have seen will continue. Additionally, the expansion of our sales team is complete.
And beginning on July 1, our dermatology clinician focused outside sales force approximately doubled in size to the mid 60s. And each of our sales representatives is selling all three of our skin cancer diagnostic product lines.
Utilizing our existing sales channels and calling on dermatologists as a primary call point, followed by Mohs surgeons, surgeons who work in skin cancer including surgical oncologists and head and neck surgeons and dermatopathologists.
We have seen that our market is promotionally responsive and we believe that our continued increase in market penetration is being positively impacted by three promotional variables. Number one, nearly 90% of our calls in the second quarter were in-person, up from just over 75% in the first quarter of 2021.
Number two, the number of average calls per day per sales reps continues to improve. And specifically, more than doubled in the second quarter of 2021 compared to the second quarter of 2020 although, it is still below the pre-COVID first quarter levels of 2020 by approximately 20%.
And number three, we are seeing a continued return to in-person peer-to-peer programs to the extent that for the first half of 2021, we've already exceeded our totals for all of 2020.
Thus, we believe that we are well positioned for continued growth for the remainder of 2021 due to these three variables combined with a doubling of our dermatology focused sales team. Turning our DecisionDx-SCC tests for patients diagnosed with high-risk cutaneous squamous cell carcinoma and one or more risk factors.
We delivered 784 rest reports in the second quarter of 2021. We remain extremely pleased with the rate of adoption for this test. We believe one clear differentiator for Castle is our position as a leader in dermatologic GEP tests.
We have seen and expect to continue to see value through leveraging our established dermatologic commercial channels for SCC as well as for our comprehensive diagnostic test offering. Third-party data shows that over 90% of dermatologists and Mohs surgeons diagnose both melanoma [ph] SCC providing us with leverage that we are seeing in the field.
And more specifically for the first six months ended June 30, 2021, approximately 70% of clinicians who ordered DecisionDx-SCC also ordered DecisionDx Melanoma. We are a data-driven evidence-based company and we invest heavily in evidence development.
At this year's American Head and Neck Society 10th International Conference on Head and Neck Cancer, we presented new data demonstrating that DecisionDx-SCC complements current risk assessment methods in patients with cutaneous squamous cell carcinoma of the head and neck.
Archival primary tumor specimens and associated data from a cohort of 278 patients from 33 different clinical sites were included in the study. The patients had high risk SCC located on the head or neck and 54 patients or 19% overall developed regional and/or distant metastasis.
Patients received either a Castle Class 1 low-risk biological test result, a Class 2 moderate biological risk test result or a Class 2B high biological risk test result had significantly different three-year metastatic free survival rates of 92.1%, 76.1% or 44.4%, respectively, with a p value of less than 0.0001.
Furthermore, as expected, using Multivariate Cox regression analysis, the decision the DecisionDx-SCC test was found to be an independent predictor of metastasis when compared to AJCC staging.
Additionally and I would say more importantly, DecisionDx-SCC had a substantially higher hazard ratio 9.07 compared to 2.51 with AJCC staging, demonstrating the increase in risk stratification compared to AJCC staging alone.
We continue - we plan to continue investing in evidence development for all of our gene expression profile tests, as it remains a key component of our growth strategy, supporting both adoption of our test by clinicians and reimbursement by commercial payers.
As we've previously discussed, the technical assessment dossier for our DecisionDx-SCC test was submitted to Palmetto and Noridian in the second quarter of 2020. We received confirmation of acceptance of this submission as being complete in the third quarter of 2020.
And although, there can be no assurances, we continued to plan for a draft local coverage determination or LCD to be posted in 2021. But I remind you that there is no specific timeframe under which Palmetto and Noridian must operate.
Now let's discuss our comprehensive diagnostic test offering for difficult-to-diagnose melanocytic lesions, also called unequivocal, uncertain or suspicious. As you may recall, in April, we announced our plans to acquire myPath Melanoma, and the deal closed in late May.
myPath Melanoma and DecisionDx, DiffDx-Melanoma, our gene expression profile test designed to provide an objective and comprehensive diagnostic test offering to a dermatopathologist and dermatologist in characterizing these difficult to diagnose melanocytic lesions has likely to be benign, malignant or in rare cases intermediate risk for malignancy.
Let me remind you, it is estimated that there are over 2 million biopsies of suspected melanoma annually in the US. Thankfully, approximately 85% of these biopsies receive a definitive diagnosis of either benign or malignant, as determined by dermatopathologists using traditional microscopic analyses.
Thus, up to 300 lesions or 15% are not constantly diagnosed with traditional histopathology. These difficult to diagnose melanocytic lesions do require additional or ancillary testing before definitive diagnosis can be reached. It is important to reduce this diagnostic uncertainty so the patient's treatment plan can be determined and implemented.
In the case of a benign lesion, the treatment plan is generally do nothing on that lesion. Whereas in the case of malignant lesion, the commission would at a minimum preferred a wide local excision and depending on the depth and other characteristics pursue a sentinel node biopsy procedure as well.
So let's talk about our acquisition of the Myriad myPath Laboratory and the Myriad myPath Melanoma test. As you may recall, a few years ago we began development on our own DiffDx-Melanoma test to address this unmet medical need to provide improved clarity around difficult to diagnose lesions.
In addition to developing a test of high sensitivity and specificity, our target product profile included the criteria of having both a low technical failure rate that is being able to report a test result out of more than 95% of orders as well as a small intermediate test result.
Our assessment of the published literature and market research was that while clinicians and dermatopathologists valued the myPath Melanoma test, they perceived the technical failure rate and intermediate rate of test is being high. As you know, we succeeded in achieving our target product profile.
However, we also knew that we would be investing additional performance studies including additional work in pediatrics to serve our customers and build market share and penetration, while competing with Myriad for the same patient population. Not to mention that we'd also have an estimated 18 to 24-month wait for Medicare coverage.
Myriad announced its intention to divest myPath Melanoma in the fourth quarter of 2020 just as we were making our DiffDx-Melanoma test available for clinical use.
We determined that housing both gene expression profile tests were difficult to use - were difficult for use and difficult to diagnose lesions and providing structure to ordering it could enable us to serve more patients more quickly. Significantly advanced the combined evidence development had moved forward reimbursement in a significant manner.
I am pleased to announce that even though we only had one full month of offering the combined diagnostic test offering that is June, we're able to deliver 627 test reports for myPath Melanoma and DiffDx-Melanoma combined for the second quarter, a record number of test reports delivered for a suspicious pigment lesion offering for a quarterly period.
Furthermore, we are also successful meeting our objective of upgrading the myPath Melanoma test ability to provide clinically actionable results. From less than 80% when offered as a standalone test to more than 95% when offered in combination with DiffDx-Melanoma.
This is a fantastic achievement and results in more patients getting an actual test result more of the time.
In addition to this performance, it's also worth noting or pointing out the National Conference of Cancer Network or NCCN guidelines support the use of ancillary testing, including gene expression profile tests for indeterminate melanocytic neoplasms following histopathology, meaning those tests are supported by the NCCN guidelines.
As you should expect, our reimbursement team is already focused - focusing on driving appropriate payment from commercial payers through the use of both a more extensive base of evidence and NCCN guidelines support.
In summary, we delivered an excellent quarter financial performance with our strong execution on our growth initiatives, delivering on our commitment to our stakeholders and continuing to create value for patients and stockholders. I'll now turn the call over to Frank, who'll provide additional detail relating to our financial results..
Thank you, Derek, and good afternoon, everyone. We are pleased that the investments we have made in our growth initiatives along with solid execution from the Castle team enabled us to deliver a strong quarter. We reported revenue of $22.8 million in the second quarter of 2021 compared to $12.7 million in the second quarter of 2020, a 79% increase.
Overall, the increased revenues reflect higher report volumes for both DecisionDx-Melanoma and DecisionDx Uveal Melanoma and higher per unit rates, partially offset by lower positive revenue adjustments related to tests delivered in prior periods. Our gross margin during the second quarter was 83%, essentially flat to the second quarter of 2020.
Our adjusted gross margin, excluding the effects of intangible asset amortization and revenue associated with test reports delivered in prior periods, was 84% compared to 79% for the second quarter of 2020. Going forward, we expect amortization of the acquired intangible asset to be approximately $700,000 per quarter.
Our total operating expenses, including cost of sales, for the quarter ended June 30, 2021, were $31.6 million compared to $13.4 million for the same period last year.
The largest driver of the increase was higher SG&A which increased by $10.4 million for the three months into June 30, 2021 compared to the same period in 2020 attributable in large part to higher personnel costs associated with our increased headcount which include salaries, bonuses, benefits and stock-based compensation.
These higher personnel costs were primarily attributable to the expansion of our sales and marketing teams as well as administrative support functions.
The remainder of the increase in SG&A was primarily associated with conferences and training events as well as higher travel costs as our commercial team returns to in-person events, as Derek mentioned. R&D expense increased by $4.1 million in the second quarter of 2021 compared to 2020.
It was primarily associated with costs incurred in our clinical studies and associated increases in personnel costs attributable to additional headcount to manage and run these studies. As we've discussed, the investments we are making in our R&D activities are a key part of our growth initiatives.
We expect our R&D expense to increase further as we continue to support our commercial products and pipeline initiatives, which we believe position us well for near and long-term growth.
Total non-cash stock-based compensation expense, which is allocated among costs of sales, R&D and SG&A, totaled $4.8 million for the quarter ended June 30, 2021 compared to $1.6 million for the quarter ended June 30, 2020.
We expect further increases in stock-based compensation expense in future periods reflecting both higher post-IPO stock option valuations as well as additional awards outstanding due to growth in our headcount. Our net loss for the second quarter of 2021 was $8.8 million compared to a net loss of $1.4 million for the second quarter of 2020.
Diluted loss per share attributable to common stockholders for the second quarter of 2021 was $0.35 a share compared to diluted loss per share attributable to common stockholders of $0.08 a share for the second quarter of 2020.
Operating cash flow for the six months ended June 30, 2021 was negative $10.1 million compared to positive $13.3 million for the same period in 2020. It was primarily attributable to the net loss, increases in working capital requirements and recruitment of a portion of the Medicare advance payment partially offset by non-cash charges.
You'll recall that the prior-year operating cash flow benefited from the seat - the receipt of $8.3 million associated with the Medicare advance payment. This year beginning in April, recoupment of the advance payment began. As of June 30, 2021, $2.2 million has been applied to the balance in recoupment.
Investing cash flows during the six months ended June 30, 2021 were primarily associated with a $33 million payment for the acquisition of myPath Melanoma. Finally, we had cash and cash equivalents at June 30, 2021 of $368 million and no debt.
As we look to the rest of the year, we have raised our annual revenue guidance to $89 million to $93 million to reflect the performance of the company over the first half of the year and the belief that the current recovery trends should continue for the remainder of the year.
We continue to invest aggressively in our growth plans, which revolve around our commercial team expansion, evidence development and progression of our pipeline tests all in order to continue to create value for clinicians, patients and stockholders. I'll now turn the call back to Derek..
Thank you, Frank.
In summary, we are extremely pleased with our second quarter performance across the entire company, on commercial execution coupled with continued evidence development enabled us to drive record test support volume for each of our proprietary gene expression profile tests and this translated into our second highest GAAP revenue and record adjusted revenue in a single quarter.
I'd like to emphasize that our strong second quarter results and continued momentum can be attributed to our purpose-driven Castle team.
Their dedication and commitment have taken us to the next level in our business and continue to make an impact in the lives of patients with skin cancer and other dermatologic diseases with high unmet clinical needs. This concludes our remarks. Thank you for your continued interest in Castle. Operator, we are now ready for Q&A..
Certainly. We will now begin the Q&A session. [Operator Instructions] The first question is from Catherine Schulte with R.W. Baird. Please proceed..
Hey, guys. Congrats on the quarter and thanks for the questions.
I guess, first, can we just get your thoughts on the delta variant impact on melanoma diagnoses and rep access is what kind of trends that you see in July and what are your assumptions embedded in your guidance for the balance of the year?.
So, we didn't pull July just closed last week. Our qualitative feedback is that across the country we aren't seeing anything necessarily in terms of rep access, although there is noise in corners as you would expect to see and it's way too early to look at third-party diagnosis at least the data we purchase in terms of predicting July.
So at this point in time we're assuming that there could be a modest impact without assuming anything like it goes back to second quarter third quarter last year.
But we're assuming that that was between the improvement that we saw in 2Q 2021 over 1Q 2021 in terms of access and calls per day as well as even though diagnoses are down still about 12% compared to 19%. We can't see how we're going to see a shutdown of medical commerce. I guess that would significantly alter our guidance right now.
That being said, we could be surprised you're in a few months in terms of the severity of a reaction but as of right now we are hearing about that. But it's still early, Catherine..
Okay. Great. And then for the reopened DecisionDx-Melanoma LCD how did those open meetings go.
And are you confident that MolDx has the data that they need to reaffirm your existing coverage criteria?.
So, maybe last question first.
So, I think the position that was put into the to the draft LCDs and they're posted back in the second quarter sort of wraps up I presume where Medicare and Medicaid are ready and WPSG see themselves which is that you have a couple of critical articles here but we don't see anything that that should result in a change in coverage.
And I think that we don't have any other intelligence that would say otherwise this point in time. I think in terms of the actual meetings that we attended participated in there was no negative discussions or questions or presentations.
I think we had an opportunity to get across quite succinctly by using a number of existing customers as well as ourselves to reinforce the strong wealth of data of what 31, 32 publications out there that support the coverage that they made a year, year and a half ago now. They made a year, and year and a half ago now.
So I think the - the meetings went well, and no indication anything different than, I guess, I would say from our perspective.
Franklin, do you want to add any comments?.
I agree..
Okay. Maybe last one for me. Your 10-Q noted that you recently started two additional studies for pipeline tests for new indications.
Any color you can share on, on what those new indications are?.
Not yet, Catherine. We'll - we'll look it at the right time when we - when we think it's appropriate to - to talk a little bit more detail about that. But for now, we're - we're not disclosing the indications just for some competitive reasons..
Okay, great. Thank you..
Thank you, Ms. Schulte. The next question is from Thomas Flaten with Lake Street Capital Markets. Please proceed..
Hey, guys. Thanks for taking the questions and congrats on the quarter as well.
Just, I was wondering if you guys could give us a quick progress report on the AD and psoriasis project that you have ongoing in terms of bringing new sites in, and et cetera?.
Yeah. Sure, qualitative only, not quantitative here. So we complete the input from not only our steering committee, but a number of other thoughtful clinical scientists, dermatologists, back in the first half of the year. The protocol was completed, locked up through our central IRB.
We are in the process of recruiting sites and opening up centers under contract and IRB approval. I would say that maybe on a qualitative basis, and we've been in kind of skin cancer diagnostics, I guess. And we were quite small in 2010 or 2011, so maybe that doesn't count.
But I would say that our clinical research operations team has never seen the kind of interest and veracity of people raise their hand up saying can I be involved with any of our programs so far? And I think we've done some exciting things now with cutaneous melanoma but also the high-risk squamous cell test.
So that tells me that we're correct in our assessment and the input that we were getting for some of our KOL advisors that there is such a huge unmet need here if you could solve this. It's going to be a fantastic gain in patient care which should be for us. So, I would say, perhaps next time we go and chat.
We'll provide some numbers in terms of progression, in terms of centers and size patients enrolled. But so far, it's early and we're seeing nothing but things that are actually exceeding our internal targets in terms of recruitment..
Great. And then just one more for me.
Given everything that's going on and I know you've only had the new field team out there for you know five, six weeks or do you have any thoughts on when we might expect to see that new expanded field team have kind of a run rate performance or production given that there's a lot of new folks out there in 12 to 18 months [indiscernible]..
Yeah so historically in non-COVID times I would say we would expect to have people kind of come 100% effective or fully effective probably what Frank five, six months in post-hire. So these individuals largely came onboard I think in April-May-ish time period completed sort of their Phase 2 training just before the 4th of July.
We had a national meeting here in July to kind of regroup the entire field force together and march out beginning August 1. I think I would say we should be able to move that up. I don't have any data for that.
So, I would still think that that our revised guidance includes the positive impact of that group which we probably see more so in the fourth quarter than the third quarter just based on assumptions of timing But the flip side of that to go back to Catherine's question would be are we going to be surprised that there's kind of a retrenchment on a rep access or patient visits by doctors that we don't account for.
So I would I would assume we're going to see continued progression in 3Q compared to second quarter and fourth year compared to the third quarter.
The question would be how hard do we hit 2022 running? Are we seeking to see continued impacts on promotional access or not? So far, we are seeing that as I commented earlier but I think that's a plus or minus there.
But probably four or five six months out is when you should start seeing a real drilling right, Frank?.
I agree..
All right. Thanks, guys. Congrats on the quarter..
Thanks, Thomas..
Thank you, Mr. Flaten. The next question is from Sung Ji Nam with BTIG. Please proceed..
Hi. Thanks for taking the questions and congrats on the quarter. For myPath Melanoma the DiffDx-Melanoma platform obviously very impressive volume there already with just one-month contribution from myPath Melanoma.
Is that it with your backlog heading into that or you know post-acquisition or is this how we could model in terms of the volume you know cadence for the rest of the year if you could talk about it? Also if you might be able to talk about the split between myPath and DiffDx-Melanoma and if not then we'd love to hear kind of if it's playing out as you guys are expecting in terms of how you're positioning the different tests available?.
Yeah. So I don't have a split in front of me here and I probably as much as well going forward to be less relevant. I don't think there was a backlog of tests. That being said we are our field forces did not mention the impending acquisition. I don't think Myriad forces it either but I don't know if that meant people were kind of waiting at all.
I don't have any kind of sense on that. So maybe there was some pent-up demand there but I'm not sure if that's the case but going forward or how we position these tests.
So our perspective was to focus on the core of what's best for the patient first and I think that what does that mean for us now we kind of have both of these assets and can do something better than we could before just doing it alone. I think that there is clearly more evidence that was developed by Myriad over the years.
They had statistics overall on accuracy that I don't think was much better than or different from in fact I would argue [indiscernible] could be slightly better but they had more data and more of it published and we launched our DiffDx-Melanoma test back in November.
We were uncomfortable with the level of pediatric data that we had in our validation set. So we chose not to even test the pediatric population till we developed additional data.
So I think overall how we present this to our customers which are both dramatic pathologists and beginning this month also dermatologists is to say hey if you have an uncertain diagnosis or you're scratching your head is difficult to diagnose.
You don't want to call it benign in case you're wrong but it's also a big leap to call it malignant melanoma. Our test is an option for you. Now we'd like to do unless you object to us is to go ahead and run my myPath melanoma test for us to why is that just based on the mountain of data. No other reason.
And if the myPath melanoma test fails to report a test result which is around what I think about 11%, 12% of the time in published literature that we can go ahead and offer you to run our DiffDx-Melanoma test as a backup to that or if we get an indeterminate score or intermediate result out of myPath Melanoma tests, we can also run our DiffDx-Melanoma test.
So rather than having us give you an actionable report result, which we would think would be benign or malignant 75% to 80% of the time, we're able to go out and show even just in the month of June we were able to take that and make it above 95%. That's a pretty good upgrade to the ability to have clarity around uncertain diagnoses.
Wouldn't you agree doctor? And so that's the discussion that we're having with physicians. I think it's the right call to make, because it does the best for patient care. And as long as we're alive, that's good for us. Now on the back end of that, the myPath Melanoma test already has an existing LCD as you know.
It already is established as an ADLT test as well. So that does pull through reimbursement for us at least on the Medicare side quite substantially. So all around it's - it's a good outcome for - for patient care if we organize test ordering and process, I just told you.
And at the end of the day, I would expect the - the bulk of the - of the differential test order is to probably be the myPath Melanoma tests for the time being, a minority being DiffDx, it would be those really that are - that are - that are non-reportable because of - of test failure or they have an intermediate myPath result.
Now as we develop additional evidence, we may find out that maybe there are populations of our DecisionDx-Melanoma test outperforms the myPath test, in which case we'll make adjustments in a very transparent fashion to customers.
Does that answer your questions?.
I think, so, yeah. Yeah..
Oh I know - I know. So for modeling wise….
Sorry..
Yeah, so modeling wise - of course, I - you would say, of course, you would say this, Derek. But I guess I would - I would not go ahead and jump from first quarter to second quarter. I would probably let us get - get third quarter numbers out. And that probably becomes more tangible going forward..
Got it. That's super helpful.
And then I just have one more follow up just we'd love to hear the progress we're making with the - with the commercial payers, especially you know you mentioned the NCCN guideline inclusion for the DiffDx-Melanoma and myPath Melanoma? You received recent the - for the SEC - DecisionDx-SCC getting the KOL the expert panel recommendations for that test as well.
Just kind of we'd love to hear kind of how those conversations are progressing with the private payers?.
Yeah. So first of all on the - on the differential side of the business, our comprehensive diagnostic offering, which includes both myPath and our DiffDx-Melanoma test. We only began those interactions I guess call it late June probably July when kind of things got moved over well, we could run the test and we're putting it out well to customers.
So I think it's too early to see how we impact that. Now my sense is that is that since the myPath Melanoma tests have been offered up for strategic divestment since last fall is that there wasn't much attention paid by the Myriad managed care folks moving that test forward because of lead time, at least that's our belief.
So I think we're starting from ground zero to something interesting. So I think as we move through the third quarter and fourth quarter, my hope would be that they're pointing to not only Medicare coverage a substantial database but also NCCN guideline inclusion should accelerate against kind of a fairly low base.
But I think it's too early to comment on success or failure on that one Sung-Ji, except that that certainly is a heavy focus of our team. But that only started here late June, early July. In terms of squamous cell carcinoma, we are moving forward on that effort as well.
Our sort of internal models was that we would be successful in appealing and getting paid on a one-off basis by a claim by claim basis in 2021. And that's part of the reason why we aren't accruing revenue.
Our historical perspective would be sort of significant commercial players are likely to want to hold back until they see something for Medicare and that that could be a draft LCD for example being posted. So I think there is an opportunity in 2022 to have us see progress.
But I would say that still is early and I would agree with you, that was a very nice article in terms of really looking at sort of some influential KOLs in high volume physicians to be frank coming together and recognizing that we need something better and this looks to be like the better solution..
Great. Thanks so much..
Thank you, Ms. Nam. There are no additional questions waiting at this time. I'll will now pass it back to Derek for closing remarks..
This concludes our second quarter 2021 earnings call. Thank you again for joining us today and for your continued interest in Castle Biosciences..
That concludes the Castle Biosciences second quarter 2021 conference call. Enjoy the rest of your day..