Good afternoon, and welcome to Castle Biosciences Fourth Quarter 2022 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 Camilla Zuckero, Vice President, Investor Relations and Corporate Affairs. Please go ahead.

Information recorded on this call speaks only as of today, February 28, 2023. 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 3 weeks. Before we begin, I would like to remind you that some of the statements made today will contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The -- these forward-looking statements include, but are not limited to, statements about our financial outlook, TAM and similar items referenced in our earnings release issued today and statements containing projections regarding future events or our future financial or operational performance, including our 2023 to 2025 outlook, our expectations and assumptions related to the impact of the COVID-19 pandemic and macroeconomic conditions and the impact of our investments in growth initiatives and expanded commercial teams. 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 annual report on Form 10-K for the year ended December 31, 2022, under the heading Risk Factors 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 non-GAAP financial measures such as adjusted revenue, adjusted gross margin and adjusted EBITDA that have not been calculated in accordance with generally accepted accounting principles in the United States or GAAP. These non-GAAP items should be used in addition to and not as a substitute for any GAAP results. We believe these metrics provide useful supplemental information in assessing our revenue, cash flow and operating 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. We are not providing a target for or reconciliation of anticipated 2025 adjusted gross margin to gross margin, the most directly comparable GAAP measure because we are unable to predict certain items contained in the GAAP measure without unreasonable efforts. 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 Fourth Quarter and Full Year 2022 Earnings Call. Across the board, 2022 represents another fantastic year of execution for Castle. Before I begin discussing the highlights of our year, I'd like to start today by personally thanking the Castle team for their excellent execution, which enabled our fantastic results. Each and every employee contributes to our success. 2022 was a year of tremendous progress for Castle. We delivered strong financial results. We made meaningful advances on our growth initiatives and delivered value to our customers and the patients we serve. The fourth quarter was a very strong finish, driving our full year revenue to $137 million, the top end of our guided revenue range and a 46% increase over 2021. Our total test reports delivered were 44,419 a 58% growth over 2021. We believe our success in 2022 provides us with momentum for 2023 and expect full year 2020 revenue in the range of $170 million to $180 million. I will now turn to highlights with each of our businesses. starting with our dermatology franchise. We delivered 37,331 dermatologic tester ports in 2022, a 41% increase over 2021. We believe our 3 dermatology offerings, DecisionDx-Melanoma, DecisionDx-SCC and MyPath Melanoma despite our continued growth, represent significant future growth opportunity. We continue to see new clinicians order our dermatologic tests for the very first time. For the year ended December 31, 2022, we saw approximately 2,312 new ordering clinicians for our dermatologic tests and total order and clinicians for Dermatologic tests were approximately 7,670. In developing our SCC test, we believe that in addition to addressing significant unmet clinical needs, we would see strategic opportunities for leverage as many of the clinicians are already ordering our risk…

Thank you, Derek, and good afternoon, everyone. We again delivered strong financial results in 2022, while continuing to make progress on our growth objectives, which we believe leaves us in a position of strength for 2023 and beyond. In the fourth quarter of 2022, we delivered total revenue of $38.3 million, a 53% increase over the fourth quarter of 2021, and we delivered $137 million for the full year 2022, a 46% increase over 2021. Overall, the increased revenues are primarily attributable to dermatologic test revenues, reflecting an increase in test report volume and higher per unit revenue. The increases in total revenue for the full year were partially offset by the effect of variations in revenue adjustments related to tests delivered in previous periods associated with changes in estimated variable consideration, which were net negative $2 million for the year ended December 31, 2022, compared to net positive $3.3 million for the year ended December 31, 2021. Revenue adjustments related to tests delivered in prior periods may fluctuate from quarter-to-quarter and over time. Our adjusted revenue, excluding the effects of revenue adjustments related to tests delivered in prior periods was $37.5 million for the quarter and $139 million for full year 2022. As Derek mentioned earlier, for 2023, we anticipate generating between $170 million and $180 million in total revenue, driven by further consistent execution of our growth plans. In order to support those growth plans, we increased the size of the organization in 2022 and head count increased from 345 on December 31, 2021, to 543 on December 31, 2022. For 2023, we expect further increases in total headcount, including the modest adjustments to our commercial team, Derek just discussed, but not to the same extent as our headcount growth in 2022. Our gross margin during the fourth…

Thank you, Frank. We are executing well against our long-term plans and are pleased with our successes in 2022. Again, we have a people-first culture, focusing on our patients, our finishing customers and our employees. It is this people-first culture, combined with offering innovative tests that drives our relentless pursuit of excellence in every aspect of our business, and we believe the momentum that we finished with in 2022, will provide us with another strong year of performance in 2023. This concludes our remarks. Thank you for your continued interest in Castle. Operator, we are now ready for Q&A.

[Operator Instructions] The first question comes from Sung Ji Nam with Scotiabank.

So maybe one for Frank. Could you talk about for your 2023 guidance, your kind of the quarterly pacing, -- just if there's going to be seasonality -- typical seasonality, how should we think about the first quarter?

Yes. Sure, Suji. I think that what we saw with the end of '22 is that we kind of have returned to a pre-COVID pattern of seasonality as it relates to melanoma diagnoses. So I think we're assuming that same kind of progression that we saw through 2019 into 2023. So the typical increased activity in the second quarter from patients identifying more lesions and more physician practice days, we would expect to see again this year.

And then just on the SCC reimbursement, could you just clarify kind of what's different from before? Just trying to figure out what's changed.

On SCC?

Yes, I just want to -- Or in something I think --

Yes. No. I think same assumptions there, Sanjay. We -- as Derek said, we are -- our guidance assumes that, that rate is durable through the year as we go through the gapfill process. And we're assuming continued coverage. If something changes there, one way or the other, we'll have to adjust, but that's where we anticipate going through the year.

The next question comes from Mason Kariko with Stephens.

This is Jacob on for Mason. I guess first just on the closure of Althea San Diego Lab facility. How should we think about the magnitude of those cost savings there? What are the majority of those savings going to show up in the P&L? And what quarter do you anticipate hitting the full run rate of those savings?

Yes, thanks. I think that we did complete that close at the end of the year. And the primary increases or primary benefits are, of course, the reduced real estate. But also we have sufficient capacity in Phoenix that we don't believe that we'll have to see the staffing level increases that we might have had to see had we remained operational in Southern California. So I think that not Q1, I don't think we fully see it through there. There's still some winding down going on. But I would -- my expectation is probably Q2, we have the full benefit of that for San Diego. Now as it relates to Pittsburgh, -- we expect to be in that facility in the second quarter. We expect to complete build-out and to be there, and it will probably take us a couple of quarters to see the full benefit from the COGS and the efficiency standpoint for the Pittsburgh transition. So we'll be in a little bit of a transition period here on the COGS side through second, third quarter as we get that done. But those are reported investments, and we think really will help us a significant amount on the COGS side as we move forward through the rest of '23 and into '24.

And then sorry if you touched on this earlier in the call, we've been juggling a future, but what's the latest update on pursuing ADLT status for the SCC test? Just kind of any updates on how you're thinking about this opportunity on a time line perspective?

So we do believe that DecisionDx-SCC would qualify for ADLT status based upon the criteria set forth in the statutes. We -- however, because that process can be short or long, we are not commenting upon timing of when that may or not take place. So I would put that as a question mark. And as Frank mentioned earlier during his monologue, that for 2023, I would have us all model or assumes $38.73 is the price for SCC. It happens to be modified or changed because of ADLT that would represent upside to that.

Our next question comes from Thomas Flaten with Lake Street.

Derek, on the ID Genetic CPT code switch, is there any recourse for you there? Or is this a decision you're stuck with? Or how are you guys thinking about that?

We're exploring opportunities and actions in our end. So we'll probably have more ratio towards the end of the first quarter or first quarter earnings.

And then just out of curiosity, you mentioned that 79% of the SEC orders also ordered DX melanoma. Is there something unique there? Is it a question of timing that all of those doctors have at some point or melanoma or is something -- is there a unique selling feature to SCC that has pushed them to that product versus having adopted melanoma previously?

That's an excellent question, Thomas. I think of a general medical dermatologist, they're going to see melanomas that will be appropriate for testing for melanoma test in squamous cell carcinomas with high-risk features. While I don't have the numbers here to necessarily give you exact differences here. We also have a group of dermatologists that are trained in Mo surgery. So Mo surgeons as a subspecialty of dermatology. There are a good number of most surgeons who don't perform Mo Surgery techniques on invasive melanoma. And so some of that delta, I would never expect it to be 100% because some of the physicians are those Mo surgeons who preferentially are seeing or at least performing surgical procedures on patients with swimmer cell carcinoma, many of whom have a high risk factor or more, but they would not be necessarily doing surgical excisions in people with invasive melanoma. So that's part of the differentiation there.

The next question comes from Kyle Mikson with Canaccord.

This is [Alex Vukasin] on for Kyle Mikson. So I guess a good place to start would be, I was just curious about a comment on whether a genetic or TC Cipher could have a meaningful contribution to your assumptions for your 2022 guidance?

We certainly have revenue in the 2023 guidance for both tissue side for an ID. But if we step back to 2022 and our conversations around those two acquisitions, those weren't about sort of creating lift in '22 or '23 in terms of revenue from a significant material perspective. Those are really about making sure that we continue to be a profitable, high-growth company in the middle of this decade and beyond. And so we do expect and we will receive, I guess, meaningful revenue from those combined products in 2023, but we're not expecting, I guess, what you would call a material impact probably until 2024, '25 and beyond. That was the real goal of those acquisitions. So that hasn't changed from a thesis perspective.

And apologies if you want to touch on this a little bit previously. But just on that new CPT code for IDgenetix in the roughly $17 range, I believe, compared to the previous quarter, a roughly $150 range for the Medicare code. I was just curious if you could elaborate on the ways in which you feel that this new code doesn't fully appreciate what the test offers you stated that in your prepared remarks. I was wondering if you could elaborate on that.

A little bit sure. So the main difference is our is that, that's a sort of generic multi-gene panel test for pharmacogenomic tests or for gene sequencing tests -- and that includes things that might cover cardiovascular disease events, Alzheimer's events, maybe even mental health, pharmacogenomic test like ours, for example. However, what we do know is that when IDgenetix was initially built, it was built upon a combination of both drug gene interactions that were then integrated using an annotation algorithm tool that incorporated drug-drug interactions and lifestyle factors as well. Those other components are clearly not covered in description of this generic multipanel code, which covers a whole variety of indications and test types. Does that add clarity?

The next question comes from Puneet Souda with SVB.

You have Michael on for Puneet. I kind of wanted to dig back a little bit on the question about the guide. So I was wondering, you mentioned tissue Cipher and maybe not a huge contributor, but how much of the guide is really driven by growth in the core melanoma versus some of the other tests like maybe SCC.

We -- as we've said, we believe most of our growth or a significant portion of the growth will be driven by the dermatology franchise this year. And so we expect to continue to grow penetration in the melanoma market and squamous cell as well. So yes, we -- including the guide expectations for higher volumes for both tests through the year.

And I was wondering with the SCL franchise now that you have this dedicated sales force is going to be, I think, fully productive in the second quarter you said? And you also have the LTD coming online for GTX. I was wondering if you should expect any sort of meaningful growth ramps there perhaps in the second half of the year.

In terms of personnel or in terms of volume, I'm assuming, right?

Volume primarily, yes.

Yes. So that would be our expectation. We only reestablished that dermatopathology focused group in, I guess, late September of 2022. So we do believe that we don't get full productivity in our sales teams until about 6 months after their training in the field. So we obviously are seeing an impact now. We should see an impact in the first quarter of 2023, but we really would expect that to hit the ground running beginning late 2Q and the fall. So yes, is a short answer that we should see continued growth and acceleration of growth with those investments being made late last year.

The next question comes from Mark Massaro with BTIG.

This is Vivian on for Mark. So as far as your 8% to 85% growth margin target by 2025, which doesn't look too far off. Can you just remind us of what remaining levers you're hoping to pull to reach that target?

Sure. So as we said, we expect to see the benefits of the rationalization of our laboratories through this year and into that period of time. So the -- we were strained for capacity in Pittsburgh, which, of course, limits efficiency. And in the case of Southern California, we have great efficiencies in our Phoenix Lab that we think benefit there. So the primary levers are rationalizing those labs, continued scale, which, of course, absorbs fixed cost and continuing to drive the number of tests that are currently not paid or reimbursed appropriately and converting those to being appropriately reimbursed.

And just a quick follow-up. Could you potentially refresh us on the publication of the MPI data and how you're expecting that to unlock any reimbursement here?

Sure. So -- the publication is in the review process of being -- of having that submitted and undergoing comments. We obviously don't control timing of the journal's speed of review and acceptance and online publication timing. It's our expectation or hope or our belief that, that should be published in the first half of this year, at least based upon current trends that we're seeing from a review cycle standpoint and clearance that of NCI. So that would be the timing of it, at least by the end of June, I would think is a reasonable assumption. In terms of what that means impact-wise, we have been discussing with our customers for most of 2022, some of the preliminary abstract data. So there is awareness among customers of the value of our test is being proven out by this real-world large-scale prospective study population as reported up through the NCIC program. That's not nearly as effective as having a peer-viewed publication to walk through in detail as you can expect. So we would expect on the physician penetration standpoint to really have another hit in terms of accelerating awareness of the value of our test, not just in terms of having the risk ratification confirmed in this large unselected patient population, but also in terms of the survival benefit that patients are experiencing when they're clinically tested with DecisionDx-Melanoma. Presumably, those results are then followed or impacting patient care compared to patients who do not receive our test clinically. So that should be more impactful, I would think, when you have a full prepublication to have a clinician really wrestle and challenge and also read through what the actual study entailed in all the fine detail. Separately, we would expect that this is the kind of outcome data that we hear from our commercial payers and laboratory benefit managers, which is I hear you in terms of what your test does. It looks like it can reduce the frequency of unnecessary similar to biopsy surgical procedures, and I understand and appreciate the risk ratification in terms of reducing overtreatment in terms of patients who have a lower risk of recurrence likelihood than if you use staging alone. So I appreciate all that. But can you show me, Derek, that actual patient outcomes, death outcomes are actually improved if I pay for your test versus don't. And that NCR article does exactly that. Now I wouldn't expect us to see policy coverage change in time, but I would hope as we go out through the remainder of 2023 and 2024, that becomes that significant landmark study that would force a commercial payer to actually say, you're right. We've been asking for this as being a litmus test of coverage that's been met right now. But again, I wouldn't see that being an automatic dime turn in July 2023. That's going to occur over a period of time.

Our next question comes from Catherine Schultz with Baird.

This is [Tom] on for Catherine. Wondering if you could just kind of build on that last point here, and maybe just give us a status update on the commercial payer progress towards Dx-Melanoma? And specifically just any expectations throughout potential NCCN guideline inclusion for '23?

Sure. A couple of comments there. It continues to be challenging to push over commercial payers. As I think you know, they are not necessarily swayed by evidence, but are driven by other factors. We did have some nice wins in the year that will begin to be implemented in 2023. But as we said before, I think that's going to continue to be steady but slow progress. And really, I think it would take an NCCN positive inclusion to see any kind of step-wise increase in the rate there.

Now in terms of NCC and timing, as your second question there, Tom, historically, the melanoma group has had their in-person or a significant meeting, I guess, in the July time period that are you had July time period of each year, and the outcome of that is usually published at year-end, December, early January or late November. So I would not expect to see any material updates for the remainder of 2023 until we get to that year-end publication date, which reflects sort of their mid-summer meeting cycle.

And then we touched on this before, but in getting the gross margin pacing for the year. I heard the comments for the clients on sort of the lab rationalization in the tech here. But just curious about how you're thinking about gross margin pacing overall and how we should think about contribution from these tests, just some of the forward contribution?

I think that as with the other trends, that will be sort of a progressive trend, nothing stepwise appears to be there. And in addition to efficiencies, of course, converting those zero pay tests to being paid has a big impact because that drops straight through. So we'll continue to see that. We would expect to see that move the right direction here over time, but in a slower methodical pace.

Those are all the questions we have for today. So I'll now turn the call back to Derek for concluding remarks.

This concludes our fourth quarter and full year 2022 earnings call. Thank you again for joining us today and for your continued interest in Castle Biosciences.

Thank you, everyone, for joining us today. This concludes our call, and you may now disconnect your lines.