Q3 2021 Castle Biosciences Inc Earnings Call

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Good afternoon, and welcome to Castle Biosciences third quarter, 2021 conference call. As a reminder, today's call is being recorded. I'll begin today's call with opening remarks and introductions followed by question and answer session. I would now like to turn the call over to Camilla Zuckero, Executive Director of Investor Relations and corporate communication. Please go ahead.

Good afternoon, and welcome to Castle Biosciences third quarter, 2021 conference call. As a reminder, today's call is being recorded. I'll begin today's call with opening remarks and introductions followed by question and answer session. I would now like to turn the call over to Camilla Zuckero, Executive Director of Investor Relations and corporate communication. Please go ahead.

As a reminder, today's call is being recorded.

I'll begin today's call with opening remarks, and introduction followed by question and answer session I would now like to turn the call over to know what's your throat.

Executive director of Investor Relations and corporate communication. Please go ahead.

Thank you operator, good afternoon, everyone. Welcome to Castle Biosciences third quarter 2021 financial results Conference call. Joining me today is Castle's founder President and Chief Executive Officer, Derek Meatzold and Chief Financial Officer, Frank Stokes.

Information recorded on this call speaks only as of today November 8th 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.

Information recorded on this call speaks only as of today November 8th 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.

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 the safe Harbour 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 September 30th 2021, and then the company's other documents and reports filed with the Securities and Exchange Commission.

And are made pursuant to the safe Harbour 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 September 30th 2021, and then the company's other documents and reports filed with the Securities and Exchange Commission.

We're 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.

are described in detail in the company's quarterly report on Form 10-Q for the quarter ended September 30th 2021, and then 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.

Metrics provide useful supplemental information and 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. Hello, and good afternoon, everyone. Thank you for joining us today for castle third quarter 2021 earnings call. We are pleased to discuss with you this afternoon, another strong quarter, including a 54% increase in revenue and a  71% increase in adjusted revenue year over year, despite the lingering impacts of decreased cutaneous melanoma diagnoses of 16%, compared to historical pre COVID-19 numbers in 2019. In August we raised our 2021 revenue guidance to 89 million to $93 million.

Thank you. Hello, and good afternoon, everyone. Thank you for joining us today for castle third quarter 2021 earnings call. We are pleased to discuss with you this afternoon, another strong quarter, including a 54% increase in revenue and a  71% increase in adjusted revenue year over year, despite the lingering impacts of decreased cutaneous melanoma diagnoses of 16%, compared to historical pre COVID-19 numbers in 2019. In August we raised our 2021 revenue guidance to 89 million to $93 million.

Thank you for joining us today for castle third quarter 2021 earnings call.

We are pleased to discuss with you. This afternoon, another strong quarter, including a 54% increase in revenue and a <unk>.

71% increase in adjusted revenue year over year, despite the lingering impacts of decreased cutaneous melanoma diagnoses of 16%, compared to historical pre COVID-19 numbers in 2019. In August we raised our 2021 revenue guidance to 89 million to $93 million.

We are pleased to say that we are on track to meet this increased range. As I just noted third quarter 2021, cutaneous melanoma diagnosis were down 116% compared to the pre-COVID third quarter 2019, but it is too soon to know the impact on fourth quarter diagnoses.

As I, just noted third quarter 2021, cutaneous melanoma diagnosis.

116% compared to the pre Covid third quarter 2019, but it is too soon to know the impact on fourth quarter diagnoses.

We can tell you that October was solid with trends similar to third quarter trends, but I would note that all else being equal fourth quarter volume is typically flat to slightly lower than 3Q due to the holidays and fewer working days. However, we may see some positive offsets to these factors in the fourth quarter from successes in our growth initiatives, including our expanded commercial team and recent publications have evidence supporting our test. I'll discuss this in more detail in a moment. You may recall from the onset of the pandemic, we made the strategic decision to accelerate investments in our growth initiatives, including expanding our commercial team as well as our R&D programs both for our commercial and pipeline tests.

We can tell you that October was solid with trends similar to third quarter trends, but I would note that all else being equal fourth quarter volume is typically flat to slightly lower than 3Q due to the holidays and fewer working days. However, we may see some positive offsets to these factors in the fourth quarter from successes in our growth initiatives, including our expanded commercial team and recent publications have evidence supporting our test. I'll discuss this in more detail in a moment. You may recall from the onset of the pandemic, we made the strategic decision to accelerate investments in our growth initiatives, including expanding our commercial team as well as our R&D programs both for our commercial and pipeline tests.

initiatives, including our expanded commercial team and recent publications have evidence supporting our test. I'll discuss this in more detail in a moment. You may recall from the onset of the pandemic, we made the strategic decision to accelerate investments in our growth initiatives, including expanding our commercial team as well as our R&D programs both for our commercial and pipeline tests.

Commercial and pipeline tests.

These decision because we believe they would ensure we remain in a position to impact patient care, ensure our resiliency and continue creating value for stockholders in the near and long term. Further, we identified two additional areas of strategic growth that we believe complement our existing business and align with our focus of addressing indications with unmet clinical needs to improve patient care. The first was our acquisition of the myriad My path laboratory LLC and the associated myPath melanoma test. And more recently the pending acquisition of Cernostics.

Resting indications with unmet clinical needs to improve patient care. The first was our acquisition of the myriad My path laboratory LLC and the associated <unk> melanoma test and more recently the pending acquisition of <unk> optics.

We are seeing excellent progress across these initiatives, which I will discuss today, followed by Frank providing additional detail on our financial results.

As always it is important to begin with a special thank you to the Castle team. I'm proud of their commitment to patients and their consistent execution, which enabled us to deliver another strong quarter and further our position as the leader in dermatologic diagnostics.

We delivered 7,727 total gene expression profile test reports in the third quarter of 2021, compared to 4,779 in the same period of 2020. This includes 5505 decision DX melanoma test reports delivered. 25% growth compared to 2020, and 33% growth compared to 2019, despite cutaneous melanoma diagnoses remaining below historical 2019 levels by approximately 16%. Based upon our analysis of third party data.

We delivered 7,727 total gene expression profile test reports in the third quarter of 2021, compared to 4,779 in the same period of 2020. This includes 5505 decision DX melanoma test reports delivered. 25% growth compared to 2020, and 33% growth compared to 2019, despite cutaneous melanoma diagnoses remaining below historical 2019 levels by approximately 16%. Based upon our analysis of third party data.

<unk>, 25% growth compared to 2020, and 33% growth compared to 2019, despite cutaneous melanoma diagnoses remaining below historical 2019 levels by approximately 16%.

Used upon our analysis of third party data.

As we've discussed we expanded our sales team to around 60 to 65 dermatology facing representatives in the second quarter of 2021, and they completed training and we're on the ground beginning on July 1st.

With this expansion each of our sales representatives are now promoting and educating on all three of our proprietary skin cancer test offerings, utilizing our existing sales channels and calling on dermatologists as their primary call point.

The team grew their experience in territory knowledge in the third quarter, and we expect them to continue toward optimal productivity, which we believe takes about two quarters. During the quarter, approximately 90% of our sales calls were in-person, which is consistent what we saw in the second quarter of 2021. Importantly, we have consistently increased our in person group peer to peer programs compared to the third quarter of 2020. And these continue to be widely attended.

The team grew their experience in territory knowledge in the third quarter, and we expect them to continue toward optimal productivity, which we believe takes about two quarters. During the quarter, approximately 90% of our sales calls were in-person, which is consistent what we saw in the second quarter of 2021. Importantly, we have consistently increased our in person group peer to peer programs compared to the third quarter of 2020. And these continue to be widely attended.

consistently increased our in person group peer to peer programs compared to the third quarter of 2020. And these continue to be widely attended.

We believe this reinforces the high value that our tests provide to clinicians and their patients.

At the beginning of the pandemic, we actively search for methods to increase our engagement with clinicians to counteract the limited in-person access to offices.

We determined that accelerating our plans to integrate our ordering process with the electronic health record systems, our customers use would be beneficial for a variety of reasons, even once offices reopened.

We began integrating our ordering process with electronic medical records platforms out of individual practice by practice basis earlier last year.

And last week, we announced our agreement to establish the interface with modernizing medicines electronic health record system Emma. Our interface with this system is expected to streamline the ordering process. The Emma platform has been ranked number one by a dermatologist for the past eight years by Black book.

And last week, we announced our agreement to establish the interface with modernizing medicines electronic health record system Emma. Our interface with this system is expected to streamline the ordering process. The Emma platform has been ranked number one by a dermatologist for the past eight years by Black book.

We interfaced with this system is expected to streamline the ordering process.

Our platform has been ranked number one by a dermatologist for the past eight years by Black book.

The interface designed to enable dermatologic clinicians to order Castle's DecisionDx skin cancer tests. And then to receive and review results from directly within a patient's electronic medical record. We expect our interface with Emma to be complete by the end of this year.

The interface designed to enable dermatologic clinicians to order Castle's DecisionDx skin cancer tests. And then to receive and review results from directly within a patient's electronic medical record. We expect our interface with Emma to be complete by the end of this year.

And then to receive and review results from directly within a patient's electronic medical record. We expect our interface with Emma to be complete by the end of this year.

We expect our interface with Emma to be complete by the end of this year.

As we look ahead, we have seen that our market is promotional responsive.

So we expect that our sales force expansion efforts, along with our increasing as fast a body of evidence supporting our test. We have 33 peer reviewed publications now for DecisionDx melanoma alone.

Should position us well for growth across our suite of Dermatologic tests in 2022. Turning to our DecisionDx SCC test for patients diagnosed with cutaneous squamous cell carcinoma, and one or more risk factors. We delivered 934 reports in the third quarter of 2021.

Turning to our decision Dx SCC test for patients diagnosed with cutaneous squamous cell carcinoma, and one or more risk factors. We delivered 934 reports in the third quarter of 2021.

We first introduced this test the market on August 31st 2020. An early adoption of this test continues to exceed our expectations. We have discussed the value of leveraging our established dermatologic commercial channels for FCC, as well as for our comprehensive diagnostic offering. And for the nine months ended September 30th 2021, approximately 76% of clinicians who order a DecisionDx SCC also order DecisionDx melanoma during that same time period.

We first introduced this test the market on August 31st 2020. An early adoption of this test continues to exceed our expectations. We have discussed the value of leveraging our established dermatologic commercial channels for FCC, as well as for our comprehensive diagnostic offering. And for the nine months ended September 30th 2021, approximately 76% of clinicians who order a DecisionDx SCC also order DecisionDx melanoma during that same time period.

Early adoption of this test continues to exceed our expectations. We have discussed the value of leveraging our established dermatologic commercial channels for FCC as well as for our comprehensive diagnostic offering and for the nine months ended September 32021, approximately 76% of clinicians who.

order a DecisionDx SCC also order DecisionDx melanoma during that same time period.

As we previously discussed the technical dossier for our DecisionDx SCC test was submitted for Mol Dx review to Palmetto and Noridian in the second quarter of 2020. And we received confirmation of acceptance of the submission is being complete in the third quarter of 2020.

As of today, the Palmetto [moldx] program has not posted a second open common period for 2021. Given the timing, we believe it's likely that the next open comment for Mol Dx LCD will be in the first quarter of 2022.

Given the timing we believe it's likely that the next open comment for Mol Dx LCD will be in the first quarter of 2022.

Moving onto our comprehensive diagnostic offering for difficult to diagnose melanocytic lesions. We delivered 913 test reports for [myPath] melanoma and DecisionDx Diff Dx melanoma combined for the third quarter of 2021.

You may recall that a few years ago, we began development of our DiffDx melanoma test to address this unmet medical need, to provide improved clarity around difficult to diagnose lesions. In addition to developing a test with high sensitivity and specificity our target product profile included the rytary of having both a low technical failure. And a low intermediate test result rate.

And a low intermediate test result, right.

That is being able to report out a clinically actionable likely benign or likely malignant test result on more than 95% of orders, we succeeded in achieving our target product profile.

And as I said earlier as part of our strategic growth plan. We identified two additional areas we believe complement our existing business and align with our focus of addressing indications with unmet clinical need, with the acquisition of AIPAC melanoma being the first word.

We determined that housing both gene expression profile tests for use in difficult to diagnose lesions and providing structure to the ordering process could enable us to serve more patients with the strongest evidence at highest clinically actionable test results possible. So the question is did we accomplish our objectives or not?

The answer is yes, and let me explain. We presented data that I'll review here at the American Society of dramatic pathology annual meeting last month.

We presented data that I'll review here at the American Society of dramatic pathology annual meeting last month.

This study reviewed clinical order data from June 30th 2021 through August 31st, 2021. Essentially the first three months that we're able to offer both my path melanoma and DiffDx melanoma under the comprehensive diagnostic operating workflow.

Essentially the first three months that we're able to offer both my path melanoma and diff Dx melanoma under the comprehensive diagnostic operating workflow.

And just this time period alone we were able to increase the reporting of actionable test results of either likely benign or likely malignant from 78% for myPath melanoma alone to 99% when used in conjunction with DiffDx melanoma, and a comprehensive diagnostic offering workflow.

<unk> 99 per said when used in conjunction with diff Dx melanoma, and a comprehensive diagnostic offering workflow.

Thus enhancing diagnostic confidence in delivery of clinically actionable results to health care providers and their patients.

In addition, we saw significant growth in our CTO volume during the third quarter and with myPath being covered under existing multi LCD, we're able to significantly advance our pull forward reimbursement timing on our CTO business compare to DiffDx melanoma alone.

The second area of strategic growth, we identify that complements our existing business and aligns with our focus of addressing indications with unmet clinical need is the pending acquisition of Cernostics and its tissue cypher platform, including the first to market tissue cipher bearish esophagus test.

We expect to close the deal before the end of 2021, we are excited about the potential our combined teams have to accelerate our impact on patient care and address the unmet clinical need embarrass esophagus.

The tissue diaper test is designed to objectively and accurately predict progression from non-dysplastic indefinite for dysplasia and low grade dysplasia bear to oesophagus to high grade dysplasia or oesophageal cancer. This is critical as oesophageal cancer carries a high mortality rate.

With five year survival rates under 20% also because intervention in patients with various oesophagus, that is oesophageal eradication therapy, which includes ablation and other interventions has been proven to reduce progression to cancer.

But unfortunately, the incidence of oesophageal cancer is increasing at one of the fastest rates of all cancers in the US. So we need new clinical tools to reverse this growth trend in the diagnosis of oesophageal cancer.

We need new clinical tools to reverse this growth trend in the diagnosis of esophageal cancer.

So what do we like about Cernostics and what are the factors that influenced our decision to acquire them at this time? Tissue cycle for bear to oesophagus sort of an indication of high clinical need by improving risk stratification for patients that had been diagnosed with non dysplastic indefinite for dysplasia and low grade dysplasia bearish oesophagus. In other words it parallels the risk stratification solutions, we offer with our DecisionDx melanoma DecisionDx SCC and DecisionDx UM tests.

So what do we like about Cernostics and what are the factors that influenced our decision to acquire them at this time? Tissue cycle for bear to oesophagus sort of an indication of high clinical need by improving risk stratification for patients that had been diagnosed with non dysplastic indefinite for dysplasia and low grade dysplasia bearish oesophagus. In other words it parallels the risk stratification solutions, we offer with our DecisionDx melanoma DecisionDx SCC and DecisionDx UM tests.

Tissue cycle for bear to solve I guess sort of an indication of high clinical need by improving risk stratification for patients that had been diagnosed with non dysplastic indefinite for dysplasia and low grade dysplasia bearish esophagus in other words it parallels the risk stratification solutions, we offer with our.

DecisionDx melanoma DecisionDx SCC and DecisionDx UM tests.

This is also a large market with patients that fall within the current intended use equating to 384000 patients on an annual basis.

And when assuming the current Medicare rate, the current tissue cipher intended use population alone expands our end market estimated US total addressable market by approximately $1 billion.

We also like the GI market in general with approximately 13000 or so targeted bolt clinicians. This market is of similar size to the skin cancer dermatology focused market and we have demonstrated that we know how to effectively educate and promote to a customer base of this size.

And finally, we are adding another innovative technology platform to our R&D and clinical laboratory groups, expanding beyond multi analyte gene expression profile tests to multi analyte spatial biology test. For our near term, we see tissue cipher in the Gi market as a parallel to our experience in the dermatology market. Despite having any feels team presence Cernostics has been successful in generating interest and usage from a number of GIs.

And finally, we are adding another innovative technology platform to our R&D and clinical laboratory groups, expanding beyond multi analyte gene expression profile tests to multi analyte spatial biology test. For our near term, we see tissue cipher in the Gi market as a parallel to our experience in the dermatology market. Despite having any feels team presence Cernostics has been successful in generating interest and usage from a number of GIs.

in the dermatology market. Despite having any feels team presence Cernostics has been successful in generating interest and usage from a number of GIs.

We expect to build an initial sales group of 13 to 15 Representatives. In addition to MSLs and internal sales associates.

Before I close, I am excited to share with you that we published our inaugural ESG report today. Castle was founded on the guiding principle of doing the right thing at the right time.

<unk> was founded on the guiding principle of doing the right thing at the right time.

Although we are still early in our journey as a public company, our focus on ESG factors began with our guiding principle in 2008. And related the cornerstones of integrity, transparency, collaboration and innovation. We believe building a strong ESG program that is relevant to our core business and our stakeholders is essential for succes.

Yes.

The launch of its inaugural report marks an important milestone in our journey and demonstrates our desire to move capsule forward and progress our ESG goals. Additionally, it reinforces our commitment to improve the lives of patients, positively impact our communities and ensure Castle remains a great place for our valued employees to learn and grow. I will now turn the call over to Frank who will provide additional detail relating to our financial results. Frank.

I will now turn the call over to Frank who will provide additional detail relating to our financial results Frank.

Thank you, Derek, and good afternoon, everyone. With a strong third quarter Castle continues to deliver on our stakeholder commitments and made considerable progress on our growth initiatives.

In the third quarter of 2021, we delivered total revenue of $23.5 million, a 54% increase over the third quarter of 2020. 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.

Decision Dx uveal melanoma and higher per unit rates.

Partially offset by lower positive revenue adjustments related to tests delivered in prior periods.

The higher per unit rates reflect our expanded Medicare LCD for our DecisionDx melanoma test that went into effect in December of 2020.

As well as a higher Medicare rate for DecisionDx Uveal melanoma that went into effect at the beginning of this year.

Our adjusted revenue, excluding the effects of revenue adjustments related to test delivered in prior periods was $23.6 million, a 71% increase over the third quarter of 2020.

Our gross margin during the third quarter was 78% compared to 84% in the third 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 81% compared to 82% for the same period of 2020.

Our total operating expenses, including cost of sales for the quarter ended September 30th 2021 were $35.3 million compared to $19.1 million for the same period last year.

The largest driver of the increase was higher SG&A, which increased by $10.9 million for the three months ended September 30th 2021, compared to the same period in 2020. Attributable in large part to higher personnel costs associated with our increased head count.

Which includes 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.

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 the return of in person and hybrid conferences, in-person peer to peer promotional programs and training events as well as a partial return to more normalized travel costs.

R&D expense increased by $4.4 million in the third quarter of '21 compared to 2020 and it was primarily associated with increases in personnel costs attributable to additional head count to manage and run our clinical studies and increases in other expenses associated with increased clinical study activity.

As we continue to support our commercial products as well as our pipeline initiatives and continue to expand our body of evidence we expect our R&D expense to increase further.

Total noncash stock based compensation expense, which is allocated among cost of sales R&D and SG&A totalled $5.2 million for the quarter ended September 30th 2021, compared to $2.1 million for the quarter ended September 30th 2020. We expect further increases in stock based compensation expense in future periods, reflecting both higher post IPO stock option valuation as well as additional awards outstanding due to growth in our head count.

$5 $2 million for the quarter ended September 32021, compared to $2 $1 million for the quarter ended September 32020, we expect further increases in stock based compensation expense in future periods, reflecting both higher post IPO stock option valuation as well as additional awards outstanding due to growth in our head count.

Our net loss for the third quarter of 2021 was $11.8 million compared to a net loss of $4.6 million for the third quarter of 2020. Diluted loss per share attributable to common stockholders for the third quarter of 2021 was 47 cents. Compared to a loss of 23 cents for the third quarter of 2020.

Compared to a loss of 23 for the third quarter of 2020.

Operating cash flow for the nine months ended September 30, 2021 was negative $16.2 million compared to a positive $10.3 million for the same period in 2020. It was primarily attributable to the net loss as well as the recruitment of a portion of the Medicare advanced payment and increases in working capital requirements, partially offset by noncash charges.

Set by noncash charges.

You'll recall that the prior year operating cash flow benefited from the receipt of $8.3 million associated with the Medicare advanced payment.

This year beginning in April recruitment of the admits payment began. As of September 30, 2020, $5.3 million has been applied to the balance in recruitment.

Investing cash flows during the nine months ended September 30, 2021 were primarily associated with the $33 million payment for the acquisition of myPath melanoma.

Primarily associated with the $33 million payment for the acquisition of my past melanoma.

Finally, we had cash and cash equivalents at September 30, 2021 of $363 million and no debt. Now I'll turn the call back over to Derek.

Now I'll turn the call back over to Derek.

Thank you Frank. As always, none of our achievements are possible without the hard work and strong execution of the Castle team, whose dedication enables us to deliver on our commitments to our stakeholders and importantly, continuing to impact patient care.

Thank you Frank. As always, none of our achievements are possible without the hard work and strong execution of the Castle team, whose dedication enables us to deliver on our commitments to our stakeholders and importantly, continuing to impact patient care.

As always none of our achievements are possible without the hard work and strong execution of the castle team.

Whose dedication enables us to deliver on our commitments to our stakeholders and importantly, continuing to impact patient care.

Our progress on our growth initiatives in the third quarter, including expansion of our dermatologic commercial team and our R&D programs, both for our commercial and pipeline tests positions us well for continued value creation. This concludes our remarks.

This concludes our remarks.

Thank you for your interest in Castle. Operator, we are now ready for Q&A. Thank you.

Operator, we are now ready for Q&A.

Thank you.

If you would like to ask a question, please press star one on your telephone keypad. If for any reason you would like to remove that question, please press star followed by Q. Again to ask a question, press star one.

Again to ask a question Christa.

As a reminder, if you are using a speaker phone, please remember to pick up your handset before asking your question. We will pass you briefly as questions registered. The first question comes from [inaudible] with BTIT. Please proceed.

Yeah.

The first question comes from Celgene with Pete.

With B T. Please proceed.

Hi. Thanks for taking the question. Maybe Derek could you talk about you know now it's been a year right since we've seen delays in terms of melanoma diagnosis. Are you hearing anything from the ground in terms of potential impact that that's been happening as far as you know the the stages of diagnosis or whatnot that you might be hearing?

Hi. Thanks for taking the question. Maybe Derek could you talk about you know now it's been a year right since we've seen delays in terms of melanoma diagnosis. Are you hearing anything from the ground in terms of potential impact that that's been happening as far as you know the the stages of diagnosis or whatnot that you might be hearing?

Maybe Derek could you talk about you know now.

It's been a year right since we've seen delays in terms of melanoma diagnosis are you hearing anything from the ground in terms of potential impact that that's been happening as far as.

You know the the stages of diagnosis.

or whatnot that you might be hearing?

We have heard a number of informal comments that I think will be publicly available shortly about what offices are seeing around the US.

We have heard a number of informal comments that I think will be publicly available shortly about what offices are seeing around the U S.

I don't think we're going to see any kind of increased dramatically in terms of people diagnosed with [melanoma] that's already spread either regionally or additionally, so so called stage three or four.

What we are seeing it in a couple of different meetings this fall is that things like the thickness of the tumour called Breslow thickness of melanoma appears to be creeping up. Which to us is that patients are not being diagnosed as a fairly ancillary to other health care visits by their primary care physicians for example. But they are actually only it's only going in because they a mall has gotten big enough, where they're concerned that could be melanoma. And I think that's where the risk of the patient population is. So my summary, I think is that since the impact COVID-19 pushed so many people to be comfortable with telehealth or just prescription renewals over the phone in the last 18 months is that as those 20% of the patients that worked being seen in person and having that mole on the back of their neck or their side of their ear be picked up ancillary those are the ones that are being missed.

What we are seeing it in a couple of different meetings this fall is that things like the thickness of the tumour called Breslow thickness of melanoma appears to be creeping up. Which to us is that patients are not being diagnosed as a fairly ancillary to other health care visits by their primary care physicians for example. But they are actually only it's only going in because they a mall has gotten big enough, where they're concerned that could be melanoma. And I think that's where the risk of the patient population is. So my summary, I think is that since the impact COVID-19 pushed so many people to be comfortable with telehealth or just prescription renewals over the phone in the last 18 months is that as those 20% of the patients that worked being seen in person and having that mole on the back of their neck or their side of their ear be picked up ancillary those are the ones that are being missed.

That things like the thickness of the tumor called breslow thickness of melanoma appears to be creeping up.

Which which to us is that patients are.

not being diagnosed as a fairly ancillary to other health care visits by their primary care physicians for example. But they are actually only it's only going in because they a mall has gotten big enough, where they're concerned that could be melanoma. And I think that's where the risk of the patient population is. So my summary, I think is that since the impact COVID-19 pushed so many people to be comfortable with telehealth or just prescription renewals over the phone in the last 18 months is that as those 20% of the patients that worked being seen in person and having that mole on the back of their neck or their side of their ear be picked up ancillary those are the ones that are being missed.

A COVID-19 pushed so many people to be comfortable with telehealth or just prescription renewals over the phone in the last 18 months is that as those 20% of the patients that worked being seen in person and having that more on the back of their neck or their side of their ear be picked up ancillary those the ones that are being missed.

And when they are coming in our perception now is that there they are coming in with a little more worsened or a little more adverse melanoma in terms of thickness. Now what's that mean for Castle? I think one is that certainly there are some patients who have very very thin melanoma is like 0.1 millimetre, 0.2 millimetres thick where we have difficulty generating data showing that we actually add value in the tumours that are that thin.

And when they are coming in our perception now is that there they are coming in with a little more worsened or a little more adverse melanoma in terms of thickness. Now what's that mean for Castle? I think one is that certainly there are some patients who have very very thin melanoma is like 0.1 millimetre, 0.2 millimetres thick where we have difficulty generating data showing that we actually add value in the tumours that are that thin.

we have difficulty generating data showing that we actually add value in the tumours that are that thin.

In terms of the use of our DecisionDx melanoma test. There are also patients that are coming in with invasive melanoma. So a thickness of 0.1, 0.2, 0.3 are thicker who might've gotten diagnosed earlier was what we would call inside two or non invasive melanoma, which is really just on the epidermis layer of the skin. We don't test those with our tests. So over time, it's our belief that as these patients begin to come back either to see their primary care doctor in person on a more routine basis or work their way into a dermatology practice, will be seeing more patients diagnosed and who will actually hit the sweet spot of our test. What that hasn't happened at least yet, but it has to happen sometime because melanoma continues to go ahead and progress and evolve.

In terms of the use of our DecisionDx melanoma test. There are also patients that are coming in with invasive melanoma. So a thickness of 0.1, 0.2, 0.3 are thicker who might've gotten diagnosed earlier was what we would call inside two or non invasive melanoma, which is really just on the epidermis layer of the skin. We don't test those with our tests. So over time, it's our belief that as these patients begin to come back either to see their primary care doctor in person on a more routine basis or work their way into a dermatology practice, will be seeing more patients diagnosed and who will actually hit the sweet spot of our test. What that hasn't happened at least yet, but it has to happen sometime because melanoma continues to go ahead and progress and evolve.

In terms of the use of our DecisionDx melanoma test. There are also patients that are coming in with invasive melanoma. So a thickness of 0.1, 0.2, 0.3 are thicker who might've gotten diagnosed earlier was what we would call inside two or non invasive melanoma, which is really just on the epidermis layer of the skin. We don't test those with our tests. So over time, it's our belief that as these patients begin to come back either to see their primary care doctor in person on a more routine basis or work their way into a dermatology practice, will be seeing more patients diagnosed and who will actually hit the sweet spot of our test. What that hasn't happened at least yet, but it has to happen sometime because melanoma continues to go ahead and progress and evolve.

That are coming in with invasive melanoma. So a thickness of 0.1 0.2 0.3 are thicker who might've gotten diagnosed earlier was what we would call inside two or non invasive melanoma, which is really just on the epidermis layer of the skin. We don't test those with our tests. So over time, it's our belief.

these patients begin to come back either to see their primary care doctor in person on a more routine basis or work their way into a dermatology practice, will be seeing more patients diagnosed and who will actually hit the sweet spot of our test. What that hasn't happened at least yet, but it has to happen sometime because melanoma continues to go ahead and progress and evolve.

<unk> continues to go ahead and progress and evolve.

Gotcha. That's helpful, and then I just have one follow up. Are there any updates in terms of your non-skin cancer programs that are underway? There are any changes in terms of the timeline of what you have described.

Are there any updates in terms of your non skin cancer programs that are underway.

There are any changes in terms of the timeline of what you have described.

No. We've seen, I think we discussed this may be at our conference here in the fall.

Our conference here in the fall.

So we have yet to disclose a couple of our other targets, but all of our programs right now are running ahead of our internal estimate forecast.

I believe that what we're seeing is that most of our pipeline programs are being executed, that more high research organizations that are community-based versus hospital-based and they seem to have sort of come out of COVID ready to start new protocols, I guess, you would say and they're seeing patients.

Hi research.

Organizations that are that are community based versus hospital base and they seem to have sort of come out of Covid right.

Ready to start new protocols, I guess, you would say and they're seeing patients. So we.

We don't see any any delay in terms of timelines of our earlier estimates earlier this year.

Great. Thank you so much.

Okay.

Okay.

Thank you Ms Nan next. Your next question comes from Kyle Mikson with Canaccord. Please proceed.

Your next question comes from Kyle Mcnealy with Canaccord. Please proceed.

Thanks. Hi, guys. Thanks for taking the questions. So I wanted to start with the guidance. If I'm doing the math right. It looks like a sequential decline in revenue and total revenue and so I'm just wondering if you're assuming the same level of third quarter access like the 90% in person calls for the same type of melanoma diagnoses trends are 16% below baseline.

Thanks. Hi, guys. Thanks for taking the questions. So I wanted to start with the guidance. If I'm doing the math right. It looks like a sequential decline in revenue and total revenue and so I'm just wondering if you're assuming the same level of third quarter access like the 90% in person calls for the same type of melanoma diagnoses trends are 16% below baseline.

same level of third quarter access like the 90% in person calls for the same type of melanoma diagnoses trends are 16% below baseline.

And then just a little bit surprised given the upside the additional reps could provide. So could you talk about maybe some of the conservatism or tempered expectations that you're making in there? Thank you.

First for me, Yes, yes sure sure, Kyle. So I guess, maybe the most important thing is that we began seeing, I guess recovery is a funny word, nice changes in rows trends in sort of the May and June time period, and those carried over quite well so the third quarter. And October finished out very strong. We do know that in November there were a fewer working days because of the Thanksgiving holiday as well as in December.

First for me, Yes, yes sure sure, Kyle. So I guess, maybe the most important thing is that we began seeing, I guess recovery is a funny word, nice changes in rows trends in sort of the May and June time period, and those carried over quite well so the third quarter. And October finished out very strong. We do know that in November there were a fewer working days because of the Thanksgiving holiday as well as in December.

Sure Kyle So I guess, maybe the most important thing is that.

We began seeing I guess recovery is a funny word nice changes in rows trends in sort of the may and June time period, and those carried over quite well so the third quarter and October finished out very strong. Do know that in November there were a fewer working days because of the Thanksgiving holiday as well as in December.

Do know that in November there were a fewer working days because of the Thanksgiving holiday as well as in December.

I don't want to say we're being overly conservative, but maybe you could put it in that respect, but typically speaking in a non COVID-19 year, 2016, 17, 18, 19, you would typically see fourth quarter diagnosis of melanoma being flattish in the third quarter as part of the normal seasonality. Now that being said,  I do agree with you that that we are very pleased with the field force expansion that occurred on July 1st of this year. And it could be that we are being too conservative in hindsight as you mentioned here, we certainly don't see any negative trends through October that would cause concern, but we also felt that our guidance was adequate for the rest of the year.

I don't want to say we're being overly conservative, but maybe you could put it in that respect, but typically speaking in a non COVID-19 year, 2016, 17, 18, 19, you would typically see fourth quarter diagnosis of melanoma being flattish in the third quarter as part of the normal seasonality. Now that being said,  I do agree with you that that we are very pleased with the field force expansion that occurred on July 1st of this year. And it could be that we are being too conservative in hindsight as you mentioned here, we certainly don't see any negative trends through October that would cause concern, but we also felt that our guidance was adequate for the rest of the year.

In that respect, but typically speaking in a non COVID-19 year.

2016, 17, 18, 19, you would typically see fourth quarter diagnosis of melanoma being being flattish in the third quarter as part of the normal seasonality now that being said I.

I do agree with you that that we are very pleased with the field force expansion that occurred on July 1st of this year. And it could be that we are being too conservative in hindsight as you mentioned here, we certainly don't see any negative trends through October that would cause concern, but we also felt that our guidance was adequate for the rest of the year.

For the rest of the year.

Okay. Thanks, thanks, guys. That's helpful, I understand. And I noticed in your presentation deck that to the potential obviously for FCC and <unk> is now officially 2023. Not a huge surprise there. I'm just wondering if you could talk about the expectations for private payer and commercial payer coverage in '22 for the rest of your tests. And are there any products that are kind of better positioned to receive in a recovery sooner than others and may be just due to the growing portfolio of data or some of the guidelines effects as well. Thanks.

Okay. Thanks, Thanks, guys. That's helpful and then.

And I noticed in your presentation deck that to the potential obviously for FCC and <unk> is now officially 'twenty 'twenty three.

Not a huge surprise there I'm just wondering if you could talk about the expectations for private payer and commercial payer coverage.

In 'twenty two for the.

The rest of your tests and are there any products that are kind of better positioned to receive in a recovery sooner than others and may be just due to the growing portfolio of data or some of the guidelines.

FX as well thanks.

Yeah. So I'll try and take that apart here a little bit here. One is that given us already November eight.

One is that given us already November eight.

I think it is highly likely that we will see a eye open meeting posted by Palmetto and Noridian for the week of Christmas holidays or between Christmas and new year. So I think the likelihood of obviously, a 2021 open common meeting analyses, especially with that occurring before year end is unlikely. So our assumption here is that they must be working towards the first quarter 2022, posting and meeting set which would push by definition out about a year or so between then versus when they could have had absolutely limit of time. Turning a draft LCD to a final and formal one it could come earlier, certainly, but I think it's better to be upfront conservative than assuming a faster term. In terms of coverage on that on the commercial side of the basis. So we certainly are seeing some revenue coming in for our other newer launch tests.

I think it is highly likely that we will see a eye open meeting posted by Palmetto and Noridian for the week of Christmas holidays or between Christmas and new year. So I think the likelihood of obviously, a 2021 open common meeting analyses, especially with that occurring before year end is unlikely. So our assumption here is that they must be working towards the first quarter 2022, posting and meeting set which would push by definition out about a year or so between then versus when they could have had absolutely limit of time. Turning a draft LCD to a final and formal one it could come earlier, certainly, but I think it's better to be upfront conservative than assuming a faster term. In terms of coverage on that on the commercial side of the basis. So we certainly are seeing some revenue coming in for our other newer launch tests.

Likelihood of obviously, a 2021 open common meeting analyses, especially with that occurring before year end as is unlikely. So our assumption here is that they must be working towards the first quarter 2022, posting and meeting set which would push by definition out about a year or so between then versus when they could have had absolutely <unk>. Absolutely limit of time.

Absolutely limit of time.

A draft LCD to us to a final and formal one it could come earlier, certainly, but I think it's better to be upfront conservative and assuming a faster term in terms of coverage on that on the commercial side of the basis. So we certainly are seeing some revenue coming in for our other newer newer launch tests.

Predominantly the DecisionDx SCC test and we expect that to go and continue in modest amounts during 2022. I don't think we could expect a guideline change or update in 2022 for squamous cell carcinoma, I think that group meets in the fall I think of every year. So I think that would be probably the earliest towards the end of 2022, we would see an update which wouldn't have much effect on [passionate] through on a commercial payors. On the sort of combined diagnostic or comprehensive diagnostic offering this combined offering of myPath melanoma DiffDx melanoma.

I don't think we could expect a guideline change or update in 2022 for squamous cell carcinoma, I think that group meets.

Fall I think of every year. So I think that would be probably the earliest towards the end of 2022, we would see an update which wouldn't have much effect on on.

Not true on a commercial payors on the sort of combined diagnostic or comprehensive diagnostic offering. This this combined offering of my past melanoma Diff Dx melanoma.

We did see earlier this year earlier in 2021, a change in NCC and guidelines that recognize that gene expression profile test that assist and the diagnoses are very difficult to diagnose and elastic lesion are included there. So we would hope to see some forward movement with some of the payers in 2022 since a number of them put the NCC and guideline inclusion is sort of the final litmus test to go out and pull through from a normal reimbursement trend our coverage. So I think we have expectations for a number of things going forward in 2022.

<unk> put the NCC and guideline inclusion is sort of the final litmus test to go out and pull through from a normal reimbursement trend our coverage. So I think we have expectations for a number of things going forward in 2022.

That will hopefully build on our revenue expectations throughout the year. As it relates to the DecisionDx melanoma test. We did see some progress with smaller plans in the second and third quarter of 2021 weeks. We would expect that to go ahead and continue as we have additional evidence being published later this year and into next year as well.

That will hopefully build on our revenue expectations throughout the year. As it relates to the DecisionDx melanoma test. We did see some progress with smaller plans in the second and third quarter of 2021 weeks. We would expect that to go ahead and continue as we have additional evidence being published later this year and into next year as well.

We did see some progress with smaller plans in.

In the second and third quarter of 2021 weeks, we would expect that to go ahead and continue as we have additional evidence being published later this year and into next year as well.

Okay, that was great very helpful. And then just ask one quick question before I hop off. Nice to see the EHR integration news.

Nice to see the EHR integration news I guess.

I had two questions about that basically. Number one, could you talk about your current electronic ordering rate? If you can kind of quantify that or maybe qualify that. And also I mean do you plan on expanding to the other kind of ambulatory EHR like next gen outbreak in Athena overtime. So you're talking about the about the integration of with modernizing medicine and the Emma platform? Correct, any modernize the medicine has a large installed base I'm just wondering about the rest, thanks.

So youre talking about the about the integration of that with modernizing medicine I mean my platform.

Yeah.

Correct any modernize the medicine has a large installed base I'm just wondering about the rest thanks yeah.

One is we haven't disclosed the online ordering in the past I guess, we'll look at that may be evident in the future here. It's a small but important part of the business through our current online ordering portal with physicians who want it electronically. So that's been going on but I would say that's a

One is we haven't disclosed the online ordering in the past I guess, we'll look at that may be evident in the future here. It's it's a it's a small but important part of the business through our current online ordering portal with physicians, who want it electronically. So that's been going on but I would say that's a <unk>.

less than half of the volume because there are a number of customers who still value fax machines going over with laboratory reports. And that's just how they operate as a practice. However, that being said the opportunity to integrate both ordering processes for all of our tests by the way as well as having reports received through Emma, I think is very exciting and throughout 2021, we did test with a number of practices, an individual practice by practice solution. And when they were interested in that we saw them kind of converting business from being fax-based too to Emma-based ordering so we expect that over the course of 2022.

Through <unk> I think is very exciting and throughout 2021, we did test with a number of practices a an individual practice by practice solution and when they were interested in that we saw them kind of converting business from being fax space too to Emma based ordering so we expect that over the course of 2022.

We will see practices and it could be on a practice level. It could be on an individual clinician level go from 0% to 100% online ordering through Emma and receipt of results. I believe that's going to reduce the number of times that we might miss appropriate patients because the doctor is kind of basically that day, it's a Friday afternoon and by the time they go ahead and come back in a Monday or Tuesday forgotten do they order the test or not. This should make that much easier and smoother from a convenience standpoint. And the fact that we were able to load and all of our test offerings I think we will expect to see nice lifts throughout the year as that becomes more integrated into our customers solutions.

Procreate patients because the doctor is kind of basically that day, it's a Friday afternoon and by the time. They go ahead and come back in a Monday or Tuesday forgotten do they order the test or not this should make that much easier and smoother from a convenience standpoint, and the fact that we were able to load and all of our test offerings. I think we will expect to see nice lifts throughout the year as that becomes more integrated into our customers.

Solutions.

We certainly are entertaining talks with the other minority. Medical record companies who work with dermatologist. Keeping in mind of course that we believe at about 90 plus percent patients with melanoma are initially diagnosed and managed by community-based private practice individuals'. So some of the services, I'm thinking about epic and others, who are really have a much more command and hospital based systems don't really fall under our EMR interest per se. So we are looking forward to kind of seeing this sort of national rollout through modernizing medicine and see the impact it has on the business and then going from there.

Medical record companies, who work with dermatologist keeping in mind of course that we believe at about 90 plus percent pace.

Patients with melanoma are initially diagnosed and managed by community based private practice individuals'. So some of the <unk>.

Services, I'm thinking about epic and others, who are really have a much more command and hospital based systems don't really fall under our our EMR interest per se. So.

We are looking forward to kind of seeing this sort of national rollout through modernizing medicine and see the impact it has on the business and then going from there.

Okay. It makes sense. Really interesting to hear so I'll leave it there my questions. Thanks, so much for taking them. Thank you Mr. Mikson. The next question comes from Thomas Flaten with Lake Street. Please proceed.

Okay. It makes sense. Really interesting to hear so I'll leave it there my questions. Thanks, so much for taking them. Thank you Mr. Mikson. The next question comes from Thomas Flaten with Lake Street. Please proceed.

Yes.

<unk>.

Thank you Mr. Nixon.

Next question comes from Thomas Flaten with Lake Street. Please proceed.

Great. Thanks, guys for taking the question. I wanted to follow up on a comment both from the prepared remarks and also the press release with respect to the two quarters of time to get the sales reps to optimal productivity. I think you would put some caveats around that in past calls that it might take longer because of access et cetera. So have you seen an acceleration there? So can we expect that they are fully productive by by year end or do you think it's two quarters from now so kind of into the first half of next year? I just wanted to clarify that.

<unk> seen an acceleration there. So can we expect that they are fully productive by by year end or do you think it's two quarters from now so kind of into the first half of next year I just wanted to clarify that.

Good question. No, I don't think it's going to take a year to have them get up and running. We've had good access about 90% of our calls have been in person both second and third quarter. When he didn't see worsening through October so I wouldn't count that as something there.

No I don't think it's going to take a year to have them get up and running we've had good access about 90% of our of our calls have been in person both second and third quarter. When he didn't see worsening through October so I wouldn't count that as something there.

I do think in hindsight that we had earlier questions during the third quarter are we sort of seeing an impact of delta. If we were seeing it, I think it was covered up because of the effectiveness of our new salesforce expansion. So my expectation is that we'll hit the ground running with sort of a fully effective expansion sales force at the beginning of the year.

We had earlier questions. During the third quarter are we sort of seeing an impact of delta.

If we were seeing it I think it was covered up because of the effectiveness of our new Salesforce expansion. So my expectation is that we'll hit the ground running with sort of a fully effective expansion sales force at the beginning of the year.

Got it, and then speaking of our commercial teams I believe on the Cernostics call you had talked about having a team ready to go for January one. Is that still the plan for to support that product commercially? Yes, yes.

Got it and then speaking of our commercial teams I believe on the sirna six call you had talked about having a team ready to go for January one is that still the plan for to support that product commercially.

Yes, yes.

I think the interviews are being completed this week. We expect to have offer letters go out and people start during early December and given the profile of the individuals that we believe will go ahead and come onboard of Castle.

We expect to have offer letters go out and people start doing early December and given the profile of the individuals that we believe will go ahead and come onboard of castle.

They nearly all haven't really nice structural gastro neurology experience sets. So we would hope they hit the ground running post training in the in the early January timeframe. So that remains on track.

And then just a quick one on the atopic dermatitis psoriasis program. You guys put out the study design and in a poster I think it was a few weeks back.

Atopic dermatitis psoriasis program.

That put out the study design and in a poster I think it was a few weeks back.

And it sounds like you've set it up as a treatment selection test, but given the non-invasive sampling platform, is there an opportunity to extend that into response monitoring as well? Or how are you guys thinking about combining those two opportunities if you are?

I guess you read the poster well, didn't you? I think the first objective is to really look at which biologics or which systemic therapy of patients are highly likely to get clearance from. And by clearance we don't mean partial. We're hoping we end up with that with nearly 100% clear and some in our responders. And we expect just the opposite to go ahead and find therapies that you know this patient is going to have a modest to minimal responsive. So a physician and a patient can really. Take six off the table and put two one.

<unk>.

I think the.

The first.

<unk> is to really look at it at which biologics.

Systemic therapy of patients highly likely to get clearance from my clearance. We don't mean partial we're hoping we end up with that with nearly 100% clear and some in our responders and we expect just the opposite to go ahead and find therapies that you know this patient is going to have a modest to minimal responsive so a physician and a patient can really.

Take six off the table and put two one.

However, as you noted in the in that in that poster, there are serial collections over time. And so by response monitoring we may be able to pick up three months in advance for example, before patient begins to lose response. I think it's too early to comment on that. But that might be a great value for patient care and obviously it creates a better per patient annuity for the company going forward. If in fact we can demonstrate that.

We may be able to pick up three months in advance for example, before patient begins to lose response I think it's too early to comment on that but that might be a great value for patient care and obviously it creates a better per patient annuity for the company going forward. If in fact, we can demonstrate that.

Great. I appreciate you guys taking the questions. Thanks so much.

Great I appreciate you guys, taking the questions. Thanks, so much.

Yeah.

Thank you Mr. Flaten. The next question comes from Catherine Schulte with Baird. Please proceed.

Next question comes from Catherine Schulte with Baird. Please proceed.

Hey, guys. Thanks for the questions I. I guess first just on the expanded sales force curious if we could get a little bit more granularity there. How much of the sequential growth came from your new cohort of reps and how much more do you think that they could contribute to the fourth quarter?

I guess first just on the expanded sales force curious if we could get a little bit more granularity there how much of the sequential growth came from your new cohort of reps and how much more do you think that they could.

Contributing to the fourth quarter.

We don't we haven't analyzed those of my level per se. And maybe importantly is that we had no areas of the country and we had only 32 dermatology facing representatives with white out areas. I mean, we cover the whole US with body you said when we when we went from 32 dermatology focus people to rough to the mid sixties.

And maybe importantly as that.

We had no areas of the country and we had only 32 dermatology facing representatives with with with with with White out areas. I mean, we cover the whole U S. With body you said when we when we went from 32 dermatology focus people to rough to the mid sixties.

That wasn't sort of covering areas that we hadn't covered before where you could say you had sales of zero and you went to something. So I don't think we can accurately answer that question with any integrity.

Integrity.

We were quite pleased with seeing the growth in terms of the productivity of the overall sales groups over the course of July, August, September and October. So as I mentioned earlier to, I think it was Kyle's question.

We didn't want to come out and be overly conservative on the fourth quarter here, but we are quite pleased with the with a triangulation that we were seeing in August September and October with the expanded sales organization and that should go at them bleed as forward quite well into 'twenty two.

Okay, Great and then can you give us an update on the personalized study how enrollment is going and let me kick out early data there.

And then any additional details on the design study highlighted in your 10-Q, one be decision, making and outcomes.

Sure we've seen.

I don't we saw.

A little slower progress maybe in 'twenty 'twenty and early 'twenty one in terms of centers coming on board I think that was largely due to COVID-19 to be honest Kathryn.

Most of the early placements were at sort of academic centers, and having kind of a slow down in terms of a higher being contracting for observational studies of our sort.

That's been a nice.

This improvement over the last quarter or so so I would expect to have a see some initial data.

By the maybe the end of next year, I think that that might be aggressive about it but I think that's the reason why that number of patients that we can say hey here are patients who really benefited from the use of a PD one inhibitor, who at stage III disease and here are patients who didnt need them.

That'd be a be fantastic to help improve patient selection as opposed to saying I'm going to wait and watch and nobody gets these therapies because the data is not that strong in terms of efficacy change or theyre, all going to get a despite a number of patients who would benefit. So that's that's helpful timing.

You may have seen there was data presented at ESMO I think by Merck back in slate September of this year September 2020 wanted with the keynote 716 study that was focused on stage two b and two C. Patients. So those are people, who are sent off no negatives, but a little thicker and ugly or tumors.

<unk> patients the data there as you expect showed a treatment effect, but it was quite modest.

We presented data at the same conference that Thomas talked about a couple of weeks ago, showing the value of our test, especially our integrated model in stage to be into seeing can identify people who really.

Likely not benefit from PD, one therapy, because they have a very very slow likelihood of attacks sizing and we found those who are who are essentially train wrecks going forward. So to me those those two elements makes that they may have got a quite positive story moving into 2022 as it relates to decide that's enrolling quite well I don't think we.

It really had a.

Slowdown in 2021 in terms of enrollment largely because we had centers that are running kind of in the earlier COVID-19 periods. In 2020. So data on that study that of course is looking at patients who.

Are electing to have our tests guide.

A use of us that muscle biopsy procedure or not and then track in those same patients long term outcomes, which is similar to some other publications we had come out this spring I mean this fall.

Should also be able to see topline data, although it'll be preliminary with shorter follow up time later next year.

Okay, great. Thank you.

Thank you Mitchell.

The next question comes from Puneet <unk> with S. B B Leerink. Please proceed.

I'm, taking the questions first one is really.

I mean, this has been covered I'm sure but in terms of.

The derm practices are you seeing anything different today, and let me ask it maybe differently are you seeing any permanent change in their behavior, how they're interacting with the sales reps in terms of the.

Time that they're allowing the sales rep interaction traditionally that's been more longer in dermatology.

Any type of trend that youre seeing sort of post COVID-19 that gives you a little bit of pause in this market I'm just.

Looking in terms of the volumes.

And the impact that you saw here, we were expecting obviously, a little bit stronger pick up.

And just if you could qualify what youre seeing in the market as of currently in November that would be super helpful.

So on a macro basis.

I have not heard of any sort of structural changes are trend changes certainly on a practice by practice basis. We are aware that as kind of a delta move through that there were some practices in certain locations that so you know what let's go ahead and put off seeing you back in person for another month or two until we're comfortable.

But thats expected right puneet.

I think.

I look at sort of our data being able to have 90% of sales calls in person now for two quarters running.

Second quarter and third quarter of this year.

To be to be interesting when I compare that to I guess, what I'm hearing some of our other molecular diagnostic peers, who are seeing.

75%, 40% in person calls theres something different.

About I think about castle, and dermatology and I I want to believe that the fact that we have three product offerings that are all highly clinical actionable to dermatologists, who were diagnosing early stage skin cancer be melanoma or squamous cell carcinoma.

Is setting us something differently than that other than there's other companies who have molecular diagnostic tests, but are finding much more resistance towards getting back in person with customers. So I don't know if I want to perceive that as a a castle difference in terms of the value of our tests and the level of educational value that our representatives bring to an office.

Versus other companies, but that's but it certainly is a is that a dynamic which is different so I don't I don't I can say from a cash flow standpoint, we arent seeing cause some kind of a long term shifting that we're aware of on a macro or systemic basis it might be happening at a practice by practice space, but nothing I can point to and Ashley and say you know this is something to be concerned about going forward.

Got it and then.

Question on the Medicare a prior quarter adjustment Frank how should we think about that going forward just wanted to clarify.

And in terms of data Readouts, given the conference lineup.

Derek could you just maybe.

Lay out for us what are some of the things that we ought to watch out over the next couple of months.

Thanks for taking my questions.

Yes, so puneet.

The prior period relates to all all payer categories.

And we will continue to see that it'll it'll bounce around we will have some positive and some negative. It's I think what's important is we've gotten much better at accruing.

Our rate per test, that's but that's closer to our actual collection experience and so.

Same quarter last year was north of a million dollars in this quarter I think it was 90 Grand difference on.

24, and a half million dollars so.

That's a nice improvement there, but it'll it'll as what you know of course, you obviously see this in the other companies you cover all of the companies are going to have some prior period adjustments from time to time.

And.

Also as we said before if squamous and <unk> Dx really grow quickly.

Eventually we should see some benefit from the appeals process and that might tick off the prior period a little bit.

As relates to sort of milestone timing and 2022.

There are a couple of meetings in the January time period that.

That had a shorter abstract submission dates so that might be something to look at it in terms of the milestone of data presentation.

A D. This year I think is in March.

And they offer a late breaking opportunity that that we would hope to have some day to go in there as well so I think around the AAD time periods in area, where where you would expect to go in and see some activity are the next kind of spring meeting that's of importance to us target market wise as the American College of most <unk>.

Ledgers or AC EMS. So that's always kind of late April early may.

As Joe as you know is in June, but what we really operate in early stage skin cancers. So.

We might have activity, there, but to be honest that sounds like that's up a customer base that we care about is really dermatology for us as a company. So those are the ones that were in line up there earlier.

I would expect to go to have some important data from our <unk>.

Penetration driving perspective be presented.

Okay, so any conferences okay.

Thank you Mr <unk>.

The next question comes from Paul Knight with Keybanc. Please proceed.

Derek Thanks, Glenn.

<unk> acquisition I know you were expecting genetic test coding.

Like today or soon anything else an update was there gnostics.

Yeah, what was Oh, yes. So there is a draft LCD that but I think it's finalized either today or tomorrow, but they were already in the billing article there. So this aeronautics.

Program overall, we really like the gastro neurology channel I guess, you would say, we really like the tissue side for tests for Barrett just off I guess as you as you know it's a we think that there's around 384000 patients who are getting endoscopies every year and could be eligible for.

Paves a tissue side for test.

That's that's more than our melanoma and our squamous.

Squamous cell carcinoma test potential combined so where do we like that from that standpoint.

We also think that over the next couple of years, we'll be able to either find or developed.

Through Sarah Gnostics or through our current approach of RNA.

Some additional tests so that we can turn around in 25, maybe and say Gee.

Just like in Dermatology, you went from having a foothold to having three or four tests in your perceived by gas neurologists as being the leader in this kind of Gi space. So I think that's our vision to get there now more practically in short term.

Sir Gnostics did.

Did complete their medical evaluation review with no <unk> earlier, this year and have been receiving routine payments on all of their Medicare claims since that point in time.

They do have an established list price on the clinical laboratory fee schedule of 25 13.

Do you feel like all of the check boxes are there to say.

Let's go out and help to support appropriate use of a test that really has had.

No commercial efforts, so far and if it makes a difference to patient care, we expect to have good solid ordering uptake next year.

As we mentioned we announced the.

A deal.

Last month at our expectation here is that 'twenty. Two is building revenue and 20 threes and we won't see really accretive add but we are going to see revenue next year certainly.

And then the rank and Derek on the gross margin it was down a bit sequentially anything going on in supply chain in house.

Screening Atlantic side.

No Paul Fortunately, none of our consumables are sitting on a barge off La long Beach right now we are.

Most of our consumables come out of Waltham mass and we've had we've had no issues there and the modest impact on gross margin is really just because of the the honestly the success of the two new products we have.

Almost.

Over 1800 almost 1900.

Tests that the.

The majority of which we didn't accrue any revenue for but we did we did obviously have to book the cost associated with it so.

That's what we're seeing there is just the impact of the the.

Number of tests that were not accruing revenue for.

Yeah.

Thank you.

Thank you Paul.

Thank you Alicia and good night.

Yes.

There are no additional questions waiting at this time, so I'll pass the conference over to Derek Mitchell.

Two for closing remarks.

Thank you operator. This concludes our third quarter 2021 earnings call. Thank you for joining us today and for your continued interest in castle Biosciences.

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Q3 2021 Castle Biosciences Inc Earnings Call

Demo

Castle Biosciences

Earnings

Q3 2021 Castle Biosciences Inc Earnings Call

CSTL

Monday, November 8th, 2021 at 9:30 PM

Transcript

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