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spk04: Good afternoon and welcome to Castle Bioscience's 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 Zuccaro, Vice President, Investor Relations and Corporate Affairs. Please go ahead.
spk05: Information recorded on this call speaks only as of today, February 28th, 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 three 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. 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.
spk12: Thank you, Camilla. And good afternoon, everyone. Thank you for joining us today for CASEL's fourth quarter and full year 2022 earnings call. Across the board, 2022 represents another fantastic year of execution for CASEL. Before I begin discussing the highlights of our year, I'd like to start today by personally thanking the CASEL 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 CASEL. 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 2023 revenue in the range of $170 to $180 million. I will now turn to highlights from each of our businesses, starting with our dermatology franchise. We delivered 37,331 dermatologic test reports in 2022, a 41% increase over 2021. We believe our three 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 31st, 2022, we saw approximately 2,312 new ordering clinicians for our dermatologic tests. And total ordering clinicians for our 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 already ordering our risk stratification decision DX melanoma test would likely be the same clinicians who would be diagnosing patients with cutaneous squamous cell carcinoma with one or more risk factors, and therefore would find value in our risk stratification decision DX SCC test. We are seeing this leverage by virtue of the fact that for the year ended December 31, 2022, approximately 79% of all clinicians ordering DecisionDx SCC had also ordered our DecisionDx melanoma tests during the year. We believe the clinical value provided by our tests today, coupled with our investment and our growth initiatives, should continue to drive increased adoption. Our growth initiatives include regular commercial team assessment and evolution and R&D investments and robust peer-to-peer programs. As it relates to commercial investments, in 2022, we reestablished a dedicated sales team to focus on our gene expression profile tests to assist in the differential diagnosis of pigment lesions. This means that we have a larger team focusing on our dermatology call point, primarily supporting decision DX melanoma, and DecisionDX SCC together, and a smaller focus dedicated team focusing on the dermatopathology call point. As we have seen historically, that our target market is promotion responsive. So we believe these expanded commercial investments can contribute to continued momentum in 2023. As part of our long-term strategy, we plan to continuously assess the impact of our commercial teams including the commercial team that is now focused on DecisionDx melanoma and DecisionDx SCC, and the separate diagnostic gene expression profile commercial team focused on dermatopathology. And we'll make moderate adjustments if necessary, but ending 2023 with slightly more outside territories than we have today. In the long term, that is beyond 2023, with three dermatology offerings, we believe around 80 to 100 total outside sales territories for our dermatology commercial teams could make sense for us. As it relates to our R&D investments, in dermatology alone, we had 12 peer reviewed manuscripts published in 2022. Continuous serial publications support our educational efforts for both existing and new clinical customers. Before I turn to our gastroenterology franchise, I would like to comment on current expectations for decision DXSCC. In the late fourth quarter of 2022, CMS decided to gap fill our decision DXSCC rate. In a regular gap fill process, we would expect the outcome from this process to go into effect in January 2024. In the interim, and since we were just contractor priced in the second quarter of 2022, We expect our current rate of $3,873 to be maintained during the GAT field process in 2023. Separately, we currently have coverage through Novitas following their evidentiary review that was completed early in 2022. Separately, there is a draft broad LCD entitled DL39365, Genetic Testing for Oncology. whose purpose we believe is to streamline reviews in the future. We have no new updates from Novitas on the status of this draft LCD. Separately, Palmetto Molde X has not issued a draft LCD to date, and we have no control over timing. If and when we do receive a Molde X LCD draft, we expect it would take about 12 months to finalize, so we'd expect to have a final coverage determination from Molde X in 2024. However, as I said earlier, we have no new updates from Palmetto about a potential LCD or timing. I would now like to turn to our gastroenterology business. We delivered 2,128 tissue cipher test reports in 2022. You may recall we acquired tissue cipher in December of 2021. We have made significant progress since then with our integration efforts and look forward to the opening of our new Pittsburgh laboratory in the second quarter of 2023, which is scaled to enable us to continue processing our tissue cipher test in Pittsburgh. Additionally, we expect the Pittsburgh facility to have capacity to process our other tests as well. I will remind you that we hired the initial commercial team in early January 2022. And given the momentum that we saw in the second quarter, we added territories for our Tissue Cipher test in the late third quarter of 2022. As with our dermatology business, we will continue to assess the team and expect to add a modest number of territories as the year progresses. Finally, for Tissue Cipher, our 2023 and 2024 Medicare reimbursement rate is $4,950. As an ADLT, the Medicare rate will be recalculated for 2025 based upon payer data collection between January and June of 2023. I will now discuss our mental health business. From late April, we acquired IDGenetics. Through the remainder of 2022, we delivered 3,249 tests. As with TissueCypher, our integration efforts are progressing according to plan. And we are pleased with the momentum we are seeing. As we have stated previously, we believe the pharmacogenomic and mental health opportunity isn't just a matter of a single large market, but an opportunity to enter a series of very large markets. One of our integration objectives is to focus on those market segments where we expect the value of IDGenX will be seen by clinicians and their patients, including the value of drug-drug, and drug gene interactions with lifestyle factors all combined in a single test report. We entered 2023 with a solid commercial team in place, and we'll look to add a few territories throughout the year. One final note on our iGenX test. The iGenX multi-gene panel test is currently reimbursed by Medicare at a contract to determine price of approximately $1,500 per test. iGenX has historically been billed to Medicare using a multi-test unspecified CPT code, along with the iGenX test-specific Moldex Z code. In February 2023, Moldex notified us that as part of their annual CPT code updates, beginning in March 2023, iGenX should shift billing to a different multi-test generic gene sequencing CPT code and to continue using the iGenX-specific Z code. The new CPT code is currently contracted price at $917, while it goes through the CMS's gap-fill process in 2023. The new CPT code does not describe all the components of the Idigenics test. We therefore do not believe that the new CPT code, in conjunction with the Idigenics-specific Z code, provides additional specificity, and thus we believe the new CPT code is not appropriate for Idigenics. Now, I want to provide an update on our inflammatory skin disease pipeline test. As a reminder, the focus of this pipeline test is to be able to predict response to systemic therapy in patients who are diagnosed with inflammatory skin disease, such as psoriasis or atopic dermatitis, and are initiating therapy on a systemic therapy or are on a systemic therapy and either not receiving optimal response or experiencing treatment-limiting side effects. Development and validation of this test is occurring under the umbrella of our identity study protocols. In 2022, we presented data supporting that our noninvasive collection method had demonstrated or passed our technical thresholds. I am pleased to report that as of February 2nd, 2023, we have 54 committed sites and 507 patients enrolled in the identity study. We expect initial development data in the second half of 2023, and we believe we are on track to launch this test by the end of 2025. If successful, we believe this test would add $1.9 billion to our estimated US TAM. I would now turn the call over to Frank, who will provide additional detail relating to our financial results and what to expect in 2023.
spk07: 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 of 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 31st, 2022, compared to net positive $3.3 million for the year ended December 31st, 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 headcount increased from 345 on December 31st, 2021 to 543 on December 31st, 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 quarter was 69.4% compared to 77.6% in the fourth quarter of 2021, and our gross margin for the full year was 70.6% compared to 81.1% in 2021. Our adjusted gross margin which excludes the effects of intangible asset amortization related to our acquisitions and revenue associated with test reports delivered in prior periods, with 74.6% for the quarter and 77% for the year, compared to 82.2% and 82.6% for the same periods in 2021. We believe this compares favorably to the margin profiles of our peer companies. Our total operating expenses, including cost of sales for the quarter ended December 31st 2022 were $61.2 million, compared to $40.2 million for the prior year, and were $209.9 million for the full year, compared to $134.2 million for the full year of 2021. Sales and marketing expense increased by $37.6 million, or 76.9%, for the year ended December 31, 2022, compared to the year ended December 31, 2021. Approximately $23.1 million, or 61.4% of the increase, is attributable to higher personnel costs, including salaries, stock-based compensation, and bonuses. The remainder of the increase in sales and marketing expenses was primarily associated with travel, training events, and conference fees. General and administrative expenses increased by $18.6 million, or 49.3%, for the year ended December 31, 2022, compared to the year ended December 31st, 2021, with increases primarily attributable to higher personnel costs, including salaries, stock-based compensation, and bonuses. The remainder of the increase in general and administrative expenses was primarily associated with other general increases. R&D expense increased by $1.9 million in the fourth quarter and by $15.3 million for the full year 2022 compared to 2021. It was primarily associated with increase in personnel costs, including increases in stock-based compensation attributable to additional headcount to manage and run our clinical studies, and increases in other expenses associated with increased clinical study activity. Total non-cash stock-based compensation expense, which is allocated among cost of sales, R&D expense, and SG&A expense, totaled $36.3 million for the year ended December 31, 2022, compared to $21.7 million for the year ended December 31st, 2021. We expect to continue granting stock-based compensation awards in future periods as we continue to grow our headcount. For 2023, we expect stock-based compensation expense to increase by approximately 30 to 35% over 2022. Income tax benefit was $1.8 million for the year ended December 31st, 2022, compared to $8.7 million for the year ended December 31st, 2021. Substantially, all of the income tax benefit was attributable to a reduction of $1.6 million of our valuation allowance on net deferred tax assets resulting from our acquisition of AltheaDX in April 2022. Specifically, we took into consideration the additional deferred tax liabilities resulting from the acquisition and determined that a portion of our existing valuation allowance should be reduced. Our net loss for the fourth quarter of 2022 was $20.6 million compared to net loss of $6.4 million for the fourth quarter of 2021. And our net loss for the full year 2022 was $67.1 million compared to net loss of $31.3 million for 2021. Diluted loss per share for the fourth quarter was 78 cents compared to diluted loss per share of 25 cents in the fourth quarter of 2021. Diluted loss per share for the full year 2022 was $2.58 compared to diluted loss per share of $1.24 for 2021. Adjusted EBITDA for the fourth quarter and full year 2022 were negative $10.4 million and negative $42.6 million, respectively, compared to negative $6.9 million and negative $14.9 million for comparable periods in 2021. For the 12 months ended December 31st, 2022, net cash used in operating activities was $41.7 million compared to $19 million for the same period in 2021. Net cash used in investing activities during the 12 months ended December 31st, 2022 was $166.5 million, primarily attributable to the purchases of marketable investment securities of $135 million and the cash portion of the acquisition of AltheaDX of $27 million. In 2023, we expect our capital allocation priorities to remain consistent. These priorities include continued acceleration of our R&D efforts to build our expansive body of evidence that supports our market, as well as to develop our pipeline test, the continued assessment and evolution of our commercial team, and to a lesser priority, opportunistic tuck-in M&A in the areas of our existing franchises. Finally, we had cash, cash equivalents, and marketable securities at December 31st, 2022 of $259 million, which we expect, together with anticipated cash generation from sales of our tests, will be sufficient to operationalize our business through 2025. Before I close, I wanted to remind you that in September, we hosted an investor day where we outlined our three-year financial targets. We anticipate achieving total revenue in the range of $255 million to $330 million for the year ending December 31st, 2025, with adjusted gross margins in the range of 80% to 85%. Combining these expectations for strong top line growth and gross margins, along with a continued disciplined approach to capital allocation, we continue to expect to be net operating cash flow positive for 2025. I'll now turn the call back to Derek.
spk12: Thank you, Frank. We are executing well against our long-term plans and are pleased with our successes of 2022. Again, we have a people-first culture focusing on our patients, our clinician 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 finish with in 2022 We 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.
spk04: Thank you. If you would like to ask a question, please do so now by pressing Start, followed by 1 on your telephone keypad. In order to allow everyone in the queue an opportunity to address the Castle management team, please limit your time on the call to one question and only one follow-up. If you have additional questions, please return to the queue. Please stand by while we compile the Q&A roster. The first question comes from with Scotiabank. Please go ahead. Hi.
spk02: Thanks for taking the questions. So maybe one for Frank. Could you talk about, for your 2023 guidance, your kind of the quarterly pacing? Just, you know, if there's going to be seasonality, typical seasonality, how should we think about the first quarter?
spk07: Yeah, sure. 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.
spk02: Got it. And then just on the SEC reimbursement, could you just clarify kind of what's different from before, just trying to figure out what's changed?
spk07: I think same assumptions there, Sanjeev. As Derek said, our guidance assumes that that rate is durable through the year as we go through the gap bill 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.
spk02: Great. Thank you.
spk07: Thanks, Sanjeev.
spk04: The next question comes from Mason Carrico with Stevens. Please go ahead.
spk06: Hey, guys. This is Jacob on for Mason. Thanks for taking our questions. This first year, 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?
spk07: Yeah, 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 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 a complete build-out and to be there, and it'll probably take us a couple of quarters to see the full benefit of 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.
spk06: Okay, got it. And then, sorry if you touched on this earlier in the call, we've been juggling a few tonight, but what's the latest update on pursuing ADLT status for the SEC test? Just kind of any updates on how you're thinking about this opportunity on a timeline perspective? Thanks.
spk12: This is Derek Jacobs. So we do believe that Decision DX SEC would qualify for ADLT status based upon the criteria set forth in the statutes. However, because that process can be short or long, we are not commenting upon timing of when that may or may 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 assume 3873 is the price for SCC, and if it happens to be modified or changed because of ADLT, that would represent upside to that. Is that fair, Frank?
spk04: Our next question comes from Thomas Flatton with Lake Street. Please go ahead, Thomas.
spk08: Hey, good afternoon, guys. Thanks for taking the questions. Derek, on the ID genetics 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?
spk12: We're exploring opportunities and actions on our end. We'll probably have more information towards the end of the first quarter or first quarter earnings.
spk08: Got it. 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 there a unique selling feature to SCC that has pushed them to that product versus having adopted melanoma previously?
spk12: 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 a melanoma test, and 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 Mohs surgery. So Mohs surgeons is a subspecialty of dermatology. There are a good number of Mohs surgeons who don't perform Mohs surgery techniques on invasive melanoma. And so some of that delta, I would never expect it to be 100% because some of the physicians who have seen good value in our squamous cell carcinoma test are those Mohs surgeons who preferentially are seeing or at least performing surgical procedures on patients with squamous 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.
spk08: Thank you.
spk04: The next question comes from Kyle Mixon with Canaccord. Kyle, please go ahead.
spk09: Hi, this is Alex. I'm for Kyle Mixon. So I guess a good place to start would be I'm just curious about It's a comment on whether an ID genetics or tissue cipher could have a meaningful contribution to your assumptions for 2023 guidance. Thanks.
spk12: It's Alex, right? Yes. Yes. We certainly have revenue in the 2023 guidance for both tissue cipher and ID genetics, but 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, 2025, and beyond. That was the real goal of those acquisitions, so that hasn't changed from a thesis perspective.
spk09: Got it. And apologies if you – you might have touched on this a little bit previously, but just on that new CDC code for ID genetic in the roughly $917 range, I believe, compared to the previously quoted roughly $1,500 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. I know you stated that in your prepared remarks. I was wondering if you could elaborate on that. Thanks.
spk12: A little bit, sure. So the main differences are 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 tests like ours, for example. However, what we do know is that when IGNX 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 multi-panel code, which covers a whole variety of indications and test types. Does that add clarity?
spk09: Yes, thank you very much. Extremely helpful.
spk04: The next question comes from Puneet Sudha with SVB. Puneet, please go ahead.
spk10: Hi, you have Michael on for Puneet. I kind of wanted to piggyback a little bit on the question about the guide. So I was wondering, so you mentioned TissueCypher and iUnite, 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?
spk07: Yeah, 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, yeah, we can... including that guide or expectations for higher volumes for both tests through the year.
spk10: Yeah, thanks. And I was wondering with the SPL franchise, now that you have this dedicated sales force and it's going to be, I think, fully productive in the second quarter, you said, and you also have the LTD coming online for GIFDX. I was wondering if you should expect any sort of meaningful growth ramps there, perhaps in the second half of the year?
spk12: In terms of personnel or in terms of volume? Volume, I'm assuming, right? Volume primarily, yes. Yeah, so that would be our expectation. We only reestablished that dermatopathology focus 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 six months after they're trained 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 they 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.
spk10: Great. Thank you very much. You're welcome.
spk04: The next question comes from Mark Massaro with BTIG. Mark, please go ahead.
spk03: Hey, guys. This is Vivian on for Mark. Thanks for taking the question. So as far as your 80% to 85% growth margin target by 2025, which doesn't look too far off, Can you just remind us what remaining levers you're hoping to pull to reach that target? Thanks.
spk07: 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 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 costs, and continuing to drive the number of tests that are currently not paid or reimbursed appropriately and converting those to being appropriately reimbursed.
spk03: Awesome. Thank you. And just a quick follow-up, could you potentially refresh us on the publication of the NCI data and how you're expecting that to unlock any reimbursement here? Thanks.
spk12: Sure. So, the publication is in the review process 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 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 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 tests as being proven out by this real-world, large-scale prospective study population as reported up through the NCI SEER program. That's not nearly as effective as having a peer-reviewed 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 stratification 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 decision DX 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 peer review publication 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 a biopsy, surgical procedures. And I understand and appreciate the risk stratification 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 a dime, 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 churn in July of 2023. That's going to occur over a period of time.
spk03: Perfect. Thank you for taking the question.
spk04: Our next question comes from Catherine Short with Baird. Please go ahead, Catherine.
spk11: Thanks. This is Tom. I'm for Catherine. I'm wondering if you could just kind of build on that last point, Derek, and maybe just give us a status update on the commercial payer progress for DXL Norma. Specifically, just any expectations around potential NCCN guideline exclusions for 2023?
spk07: Sure. A couple comments there. It continues to be challenging to push over commercial payers. As I think you know, they're 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've 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 stepwise increase in the rate there.
spk12: Now, in terms of NCCN timing, as your second question there, Tom, historically the melanoma group has had their – in-person or significant meeting, I guess, in the July time period of each year. And the outcome of that is usually published at year-end December, early January, 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 midsummer meeting cycle.
spk11: Great, thanks. And then I've been testing this before, but I wanted to get into gross margin facing for the year. I heard the comments on sort of the push and take on sort of the lab rationalization and the tech there, but I'm just curious about how you're thinking about gross margin facing overall and how we should think about contributions in recess, which is kind of the core term, contributions. Thanks.
spk07: Sure. I think that as with the other trends, that'll 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 will continue to see that. We would expect to see that move the right direction here over time, but in a slower, methodical pace.
spk04: Those are all the questions we have for today, so I'll now turn the call back to Derek for concluding remarks.
spk12: 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.
spk04: Thank you, everyone, for joining us today. This concludes our call, and you may now disconnect your lines.
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