CSTL

Shares of Castle Biosciences (CSTL) have recently risen about 37%, following increasing agreement among Wall Street analysts on earnings estimate revisions that point to a more constructive view of the company’s earnings outlook. At around $34.11 per share, Castle Biosciences has seen strong recent momentum, with a 30 day share price return of about 39.6% and a 90 day share price return of about 54.3%. The 1 year total shareholder return of about 53.1% suggests that recent optimism around earnings estimates is building on a broader recovery story rather than a one off move. Spot similar momentum stories to Castle Biosciences, and compare this surge with a hand picked 51 high quality undervalued stocks that are also attracting fresh interest from analysts and investors. For Castle Biosciences, this sharp move raises a simple tension. Are investors finally catching up with what the underlying business is already delivering, or has sentiment run ahead of what the fundamentals support, as the valuation section explores next? The most followed narrative on Castle Biosciences puts fair value at $44.00 per share compared with the recent $34.11 close, which frames the current earnings optimism in a different light. Read the complete narrative. Read the complete narrative. Want to understand why this narrative still sees upside even after a sharp share price move? The story hinges on future test volumes, margin shifts, and a rich earnings multiple that only pencils out if a specific revenue and profitability path plays through. Result: Fair Value of $44.00 (UNDERVALUED) Have a read of the narrative in full and understand what's behind the forecasts. However, Castle Biosciences still faces meaningful reimbursement risk around its DecisionDx-SCC test, as well as pressure from rising operating expenses if new tests do not scale as hoped. Find out about the key risks to this Castle Biosciences narrative. The most followed Castle Biosciences narrative leans on analyst targets and future earnings power, yet the SWS DCF model points to something different. At $34.11, CSTL is trading at about a 55.3% discount to an estimated future cash flow value of $76.35, which also flags it as undervalued. If both methods agree on upside, where is the margin for error in your own assumptions? Look into how the SWS DCF model arrives at its fair value. If this sentiment around Castle Biosciences feels mixed, that is the point, and it is worth reviewing both sides of the story now. To weigh the upside against the concerns in detail, start with the 3 key rewards and 1 important warning sign. Do not stop with Castle Biosciences if you want a broader watchlist. Use the Simply Wall Street Screener to uncover stocks that better match your goals and risk comfort. Target potential long term compounders by reviewing a 51 high quality undervalued stocks that could offer more appealing entry points than recent winners. Prioritize resilience and sleep a little easier at night by focusing on a 75 resilient stocks with low risk scores with stronger risk profiles. Hunt for under followed opportunities by checking a 20 high quality undiscovered gems that many investors may still be overlooking. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Companies discussed in this article include CSTL. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email [email protected]

Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Revenue growth of 20% was primarily driven by the TissueCypher test, which saw a 63% increase in report volume compared to the prior year. DecisionDx-Melanoma volume grew 3% sequentially, a figure management noted was below typical seasonal increases as the commercial team adapted to a new model of supporting three products per customer call. The company is successfully transitioning from a single-product company to a multi-product platform across dermatology and gastroenterology, with The company reported a 40% adjusted revenue growth rate for the second quarter of 2026 when excluding revenue from DecisionDx-SCC and IDgenetix. Management attributes the strong adoption of TissueCypher to its unique ability to predict progression in Barrett’s esophagus, filling a critical clinical gap for gastroenterologists. Operational expenses increased due to merit-based wage adjustments and headcount expansion across administrative, lab, and R&D functions to support scaling volumes. The company reported an adjusted gross margin of 76.3%, a decrease from 79.5% in the second quarter of 2025, as higher test report volumes led to increased costs for lab supplies and personnel. Full-year 2026 revenue guidance was raised to $365 million–$375 million, reflecting strong first-half performance and continued momentum in core revenue drivers. TissueCypher volume is projected to grow between 50% and 52% for the full year 2026. Management expects to maintain positive adjusted EBITDA for the remainder of 2026 and through the full year 2027, assuming no major strategic shifts. The company anticipates preliminary draft 2026 Medicare clinical laboratory fee schedules in late September, which will serve as a benchmark for commercial payer negotiations for the AdvanceAD-Tx test. Strategic R&D focus remains on internally developed programs to ensure long-term value creation through 2030 and beyond, specifically within existing therapeutic areas. The DecisionDx-SCC test currently lacks Medicare coverage; management expects a potential return to coverage in 2027, contingent on positive draft LCDs in late 2026. Average Selling Price (ASP) for TissueCypher saw a one-time stepwise increase in the first half of 2026 due to accrual process modifications, which is not expected to repeat in the second half. The company is monitoring potential seasonality in TissueCypher, noting that Q1 typically sees fewer patient encounters and procedures compared to other quarters. FDA breakthrough device designation for the inflammatory skin disease pipeline is expected to expedite the review process, with potential clearance or approval targeted for late 2026 or early 2027. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. Management expressed high confidence in the $3,675 rate recommended by the panel, noting it aligns with their internal analysis of the test's value. The 21-0 unanimous panel vote for the crosswalk is seen as a strong validation of the test's technology and clinical relevance. The company is targeting approximately 100 sales territories for both GI and dermatology divisions, expanding as territories reach $2.5 million to $3 million in revenue. Management believes they are currently at the appropriate scale but noted that recent expansions in late Q2 have not yet reached full productivity. The test aims to predict atopic dermatitis flares 1.5 to 2 days in advance, allowing patients to use lower-powered topical therapies rather than high-dose steroids. Beyond flare prediction, management sees a significant opportunity in helping patients taper off rescue medications or lengthen the time between injections. The company is using the Esopredict tissue-based assay as a reflex backstop when TissueCypher results cannot be obtained due to biopsy quality. Development of a non-invasive cell collection sponge device is ongoing, with a formal update expected in the first half of 2027.

This article first appeared on GuruFocus. Revenue: $103.5 million, 20% growth compared to Q2 2025. Revenue Growth (Excluding DecisionDx-SCC and IDgenetix): 40% compared to Q2 2025. Test Report Volume Growth: Core revenue drivers grew 32% compared to Q2 2025. DecisionDx-Melanoma Test Reports: 10,280 in Q2 2026, 3% growth compared to Q2 2025. TissueCypher Test Reports: 14,988 in Q2 2026, 63% growth compared to Q2 2025. AdvanceAD-Tx Orders: More than 1,000 in Q2 2026. Gross Margin: 74.9% in Q2 2026, compared to 77.3% in Q2 2025. Adjusted Gross Margin: 76.3% in Q2 2026, compared to 79.5% in Q2 2025. Total Operating Expenses (Including Cost of Sales): $106.6 million in Q2 2026, compared to $90.4 million in Q2 2025. Sales and Marketing Expenses: $40.9 million in Q2 2026, compared to $35.1 million in Q2 2025. General and Administrative Expenses: $25.2 million in Q2 2026, compared to $22.9 million in Q2 2025. Cost of Sales: $23.7 million in Q2 2026, compared to $17.6 million in Q2 2025. R&D Expenses: $14.5 million in Q2 2026, compared to $12.8 million in Q2 2025. Net Loss: $2.1 million in Q2 2026, compared to net income of $4.5 million in Q2 2025. Diluted Loss Per Share: $0.07 in Q2 2026, compared to diluted earnings per share of $0.15 in Q2 2025. Adjusted EBITDA: $12.4 million in Q2 2026, compared to $10.4 million in Q2 2025. Net Cash Provided by Operating Activities: $15.2 million in Q2 2026. Cash, Cash Equivalents, and Marketable Investment Securities: $266.8 million as of June 30, 2026. 2026 Revenue Guidance: Raised to $365 million to $375 million, up from $345 million to $355 million. Warning! GuruFocus has detected 4 Warning Signs with CSTL. Is CSTL fairly valued? Test your thesis with our free DCF calculator. Release Date: July 30, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Castle Biosciences Inc (NASDAQ:CSTL) delivered strong Q2 2026 revenue of $103.5 million, a 20% year-over-year increase, and raised its full-year 2026 revenue guidance to $365-$375 million from $345-$355 million. TissueCypher test volume grew 63% year-over-year in Q2 2026, with the company now expecting 50%-52% volume growth for the full year, indicating strong market adoption. The company's AdvanceAD-Tx test received a unanimous 21-0 panel vote for a Medicare crosswalk to a code with a favorable rate of $3,675, which is expected to support a full commercial launch. A prospective multicenter study published in Q2 demonstrated that DecisionDx-Melanoma outperformed the MIA nomogram in identifying low-risk patients, with an actual sentinel lymph node positivity rate of just 2.6%, well below the NCCN's 5% threshold. The company reported positive adjusted EBITDA of $12.4 million for Q2 2026, up from $10.4 million in the prior year, and expects to achieve positive adjusted EBITDA for the full year 2026 and 2027. Castle Biosciences Inc (NASDAQ:CSTL) maintains a strong balance sheet with $266.8 million in cash and marketable securities, providing financial flexibility to invest in growth initiatives and pipeline opportunities. DecisionDx-Melanoma volume growth was moderate at 3% year-over-year in Q2 2026, below historical seasonality, partly due to the commercial team adapting to support three products in the same customer call. The company's gross margin declined to 74.9% in Q2 2026 from 77.3% in Q2 2025, and adjusted gross margin fell to 76.3% from 79.5%, reflecting higher costs associated with increased volumes. Castle Biosciences Inc (NASDAQ:CSTL) reported a net loss of $2.1 million in Q2 2026, compared to net income of $4.5 million in Q2 2025, driven by increased operating expenses. The company noted that the stepwise increase in TissueCypher ASP seen in the first half of 2026 is not expected to repeat in the second half, limiting potential revenue upside from pricing. There remains uncertainty regarding the timeline for Medicare coverage decisions for DecisionDx-SCC, with no public commentary on data discussions and a potential wait of up to a year after any draft LCD is posted. The company acknowledged that as TissueCypher penetration grows, the easier conversions have likely been captured, and future growth may require more effort and potentially higher expenses. Q: What are your initial thoughts on the unanimous panel vote for the AdvanceAD-Tx crosswalk, the associated rate, and the updated expectations for a full commercial launch?A: Derek Maetzold (President and CEO): We believe the crosswalk to the code for a test predicting drug response in psoriasis was the most appropriate for our atopic dermatitis test. The unanimous 21-0 vote in favor and the rate of $3,675 is a very strong outcome. We expect the preliminary draft 2026 Clinical Laboratory Fee Schedule (CLFS) rates in late September. This provides a solid benchmark for negotiations with commercial payers and positions us well to open up a full commercial launch in the future. Q: Can you provide more detail on the TissueCypher ASP trends in the second quarter, and is the raised revenue guidance mostly driven by improved volume or also ASP expectations?A: Frank Stokes (CFO): We did see a pickup in ASP in the first half of the year due to more experience with expected and actual collection rates. However, we would not expect to see the same stepwise increase in the back half of the year. The raise in our guidance is primarily based on the strong performance to date and the continued performance of our two primary revenue drivers, DecisionDx-Melanoma and TissueCypher. Q: Given the strong volume growth on TissueCypher, can you share any details on salesforce expansion to maximize this opportunity?A: Derek Maetzold (President and CEO): We continue to expand territories as they hit a forward-looking $2.5 million in revenue. We are currently at around 100 sales representatives across our gastroenterology and dermatology divisions, which we believe is close to the right size. We had expansions last year and in the late second quarter of this year, and we are already tracking toward our goal of 50% to 52% year-over-year volume growth for TissueCypher. Q: What are your top priorities for R&D investments this year, and how much do you expect R&D to increase year-over-year?A: Frank Stokes (CFO): We will continue to see some increase in R&D as we focus on newly internally developed programs. We are excited about our pipeline, which now spans two therapeutic areas with multiple products. This is a deliberate investment to ensure long-term value creation well past 2030 and 2035. The priority will remain on programs within our existing therapeutic areas that align well with our commercial footprint. Q: You saw a pickup in DecisionDx-SCC volumes for the first time since it lost coverage. What is driving this resurgence?A: Derek Maetzold (President and CEO): The primary driver is the clinical value existing customers see in the test for managing high-risk cutaneous squamous cell carcinoma patients. We have encouraged our sales force to spend a small amount of time promoting the test alongside our primary focus on melanoma. The increase is a combination of existing users, more working days in the second quarter, and some return to promotional activity. Q: Can you provide an update on the Previse GI pipeline test, specifically the Esopredict test and the cell collection device?A: Derek Maetzold (President and CEO): We made the Esopredict test available in the early first quarter of this year as a reflexive or backstop test for the few cases where we cannot get a TissueCypher result. Regarding the cell collection device (a sponge in a capsule), we have protocols that are in design and ready to go. We expect to provide an update on that, potentially in the first half of next year. Q: Regarding the Novitas and MolDX LCDs impacting the DecisionDx-SCC test, does mid-2027 remain a reasonable time frame for a potential return of payment, and have there been any recent data discussions?A: Derek Maetzold (President and CEO): We have no public commentary on data discussions with the Medicare contractors, but we have heard nothing negative. We modeled that it would take about a year to a year and a quarter for the contractors to work through the reconsideration request, which would put us in the second half of 2026. If we see a positive draft coverage LCD in the latter half of this year, we would anticipate roughly a year later for regaining coverage for Medicare beneficiaries. Q: Can you provide a timeline for the FDA approval of the device related to the breakthrough device designation?A: Derek Maetzold (President and CEO): I would separate the breakthrough device designation from approval. The designation allows us to go to the front of the line and have more leverage in addressing the FDA. We might expect to have FDA clearance or approval later this year or early next year. Q: Can you talk more about what drove the reacceleration in TissueCypher volume growth this quarter after the seasonal dip in Q1?A: Frank Stokes (CFO): We don't yet have the procedures data for the second quarter, but we likely saw more procedures than in Q1. The important focus is on the multi-quarter trend, which shows steady growth and increased penetration for TissueCypher over the last year. Q: Given the lower-than-expected seasonal volumes for DecisionDx-Melanoma in Q2, what informs your confidence in the mid-to-high single-digit growth for the year?A: Derek Maetzold (President and CEO): Our confidence comes from our internal enterprise model, which we track against actuals. Based on what we see, we believe we are still tracking toward our goal of mid-to-high single-digit growth for the full year. To estimate the second half, you would take our first-half performance and calculate the range needed to achieve the full-year target. For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Delivered Q2 2026 revenue of $103.5 millionQ2 2026 total test reports for our core revenue drivers (DecisionDx®-Melanoma, TissueCypher®) increased 32% over Q2 2025Raising full-year 2026 revenue guidance to $365-375 million from $345-355 millionConference call and webcast today at 4:30 p.m. ET FRIENDSWOOD, Texas, July 30, 2026 /PRNewswire/ -- Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, today announced its financial results for the second quarter ended June 30, 2026. "The Castle Biosciences team delivered another outstanding quarter," said Derek Maetzold, president and chief executive officer of Castle Biosciences. "We believe our strong growth through the first half of 2026 demonstrates the clinical value our tests bring to patient care and the dedication of our talented team to deliver results so that our clinician customers and patients can act with confidence. "Given this momentum, we are raising our 2026 total revenue guidance to $365-375 million, up from our previous range of $345-355 million. We also now expect to achieve positive Adjusted EBITDA for the third quarter, the fourth quarter and the full year 2026. "We are also encouraged by an independent study supporting the clinical impact of AdvanceAD-Tx™ in guiding systemic treatment selection. At the Revolutionizing Atopic Dermatitis meeting in June, data from a multi-center study showed only 54.3% of patients receiving baseline systemic therapy were initially on pathway-concordant treatment; however, following testing with our AdvanceAD-Tx test, 97.8% of patients were initiated on molecularly concordant systemic therapy. I want to thank the entire Castle team for their focus, commitment and disciplined execution, which continue to advance our mission of improving health through innovative tests that guide patient care." Second Quarter Ended Jun. 30, 2026, Financial and Operational Highlights Revenues were $103.5 million, compared to $86.2 million in the second quarter of 2025. Affecting second quarter 2026 revenue was the change in DecisionDx®-SCC Medicare coverage effective April 24, 2025, the re-focus of our commercial efforts, as well as the discontinuation of IDgenetix in May 2025. Core revenue drivers: Second quarter 2026 total test reports for our core revenue drivers (DecisionDx-Melanoma, TissueCypher) increased 32% over the second quarter of 2025: Additional tests: Gross margin was 75%, and Adjusted Gross Margin was 76%, compared to 77% and 80%, respectively, for the same periods in 2025. Net loss, which includes non-cash stock-based compensation expense of $11.6 million, was $2.1 million, compared to net income of $4.5 million for the same period in 2025. Net loss per share and Adjusted Net Loss per Share, Basic and Diluted, was $0.07, compared to net income per share and Adjusted Net Income per Share, Basic and Diluted, of $0.16 and $0.15, respectively, for the same period in 2025. Adjusted EBITDA was $12.4 million, compared to $10.4 million for the same period in 2025. Net cash provided by operations was $15.2 million, compared to net cash provided by operations of $20.8 million for the same period in 2025. Six Months Ended Jun. 30, 2026, Financial and Operational Highlights Revenues were $187.2 million, compared to $174.2 million for the six months ended June 30, 2025. Affecting comparison to 2025 includes the change in DecisionDx-SCC Medicare coverage effective April 24, 2025, the re-focus of our commercial efforts, as well as the discontinuation of IDgenetix in May 2025. Core revenue drivers: First half 2026 total test reports for our core revenue drivers (DecisionDx-Melanoma, TissueCypher) increased 34% over the six months ended June 30, 2025. Additional tests: Gross margin for the six months ended June 30, 2026, was 74%, and Adjusted Gross Margin was 77%, compared to 63% and 81%, respectively, for the same period in 2025. Net loss, which includes non-cash stock-based compensation expense of $21.4 million, was $16.6 million, compared to net loss of $21.3 million for the same period in 2025. Net loss per share and Adjusted Net Loss per Share, Basic and Diluted, was $0.55, compared to net loss per share and Adjusted Net Loss per Share, Basic and Diluted, of $0.74 and $0.04, respectively, for the same period in 2025. Adjusted EBITDA was $7.3 million, compared to $23.4 million for the same period in 2025. Net cash used in operations was $6.9 million, compared to $14.8 million net cash provided by operations for the same period in 2025. Cash, Cash Equivalents and Marketable Investment SecuritiesAs of Jun. 30, 2026, the Company's cash, cash equivalents and marketable investment securities totaled $266.8 million. 2026 OutlookCastle Biosciences is raising its guidance for anticipated total revenue in 2026. The Company now anticipates generating between $365-375 million in total revenue in 2026, compared to the previously provided guidance of between $345-355 million. Further, the Company expects to achieve positive Adjusted EBITDA for the third quarter, the fourth quarter and the full year 2026. Second Quarter and Recent Accomplishments and Highlights Dermatology - Skin Cancer The Company announced the publication of a prospective, multicenter study in Dermatology and Therapy demonstrating that DecisionDx-Melanoma's integrated sentinel lymph node biopsy test result (i31-SLNB) outperforms the Melanoma Institute Australia (MIA) nomogram in identifying patients at low and high risk of SLN positivity, supporting more informed SLNB decision-making for patients with cutaneous melanoma (CM). This is the second multicenter study showing that the i31-SLNB result outperforms the MIA nomogram in assessing SLN positivity risk. See the Company's news release from June 25, 2026, for more information. Dermatology - Atopic Dermatitis The Company announced that its AdvanceAD-Tx test has received assay approval from the New York State Department of Health (NYSDOH). With this approval, Castle has New York State approval for all tests within its dermatology and ophthalmology portfolios, its TissueCypher test within gastroenterology and its clinical laboratories in Phoenix and Pittsburgh. See the Company's news release from July 14, 2026, for more information. The Company announced that its AdvanceAD-Tx test was selected as the winner of the "Genomics Innovation Award" in the 10th annual MedTech Breakthrough Awards program, which recognizes companies driving meaningful progress and improving patient care across the global health and medical technology industry. AdvanceAD-Tx is Castle's clinically validated gene expression profile (GEP) test designed to guide systemic treatment decision making in patients 12 and older with moderate-to-severe atopic dermatitis (AD). This marks the fifth MedTech Breakthrough Award that Castle has earned for its innovative testing solutions. See the Company's news release from May 12, 2026, for more information. Pipeline Initiatives In June 2026, the first patient was enrolled in DETECT-AD, a multicenter prospective clinical study being conducted through Castle's collaboration with SciBase, a global medical technology company, specializing in early detection and prevention in dermatology. The study will investigate the ability of Electrical Impedance Spectroscopy (EIS) to predict the onset of flares in patients with AD, with the goal of enabling proactive interventions and improving patient quality of life. Corporate The Company announced that Frank Stokes, its chief financial officer, has been named a 2026 CFO Awards honoree by the Houston Business Journal. Stokes is among 22 chief financial officers from across the Greater Houston area recognized for their financial leadership and contributions to their organizations' success. See the Company's news release from June 23, 2026, for more information. Conference Call and Webcast DetailsCastle Biosciences will hold a conference call on Thursday, July 30, 2026, at 4:30 p.m. Eastern time to discuss its second quarter 2026 results and provide a corporate update. A live webcast of the conference call can be accessed here:https://event.choruscall.com/mediaframe/webcast.html?webcastid=gbu0MZxe or via the webcast link on the Investor Relations page of the Company's website, https://ir.castlebiosciences.com/.Please access the webcast at least 10 minutes before the conference call start time. An archive of the webcast will be available on the Company's website until August 20, 2026. There will be a brief Question & Answer session following management commentary. Use of Non-GAAP Financial Measures (UNAUDITED) In this release, we use the metrics of Adjusted Revenues, Adjusted Gross Margin, Adjusted EBITDA and Adjusted Net (Loss) Income per Share, Basic and Diluted, which are non-GAAP financial measures and are not calculated in accordance with generally accepted accounting principles in the United States (GAAP). Adjusted Revenues and Adjusted Gross Margin reflect adjustments to GAAP net revenues to exclude net positive and/or net negative revenue adjustments recorded in the current period associated with changes in estimated variable consideration related to test reports delivered in previous periods. Adjusted Gross Margin further excludes acquisition-related intangible asset amortization. Adjusted EBITDA excludes from net loss: interest income, interest expense, income tax benefit or expense, depreciation and amortization expense, stock-based compensation expense and net losses (gains) on equity securities. Adjusted Net (Loss) Income per Share, Basic and Diluted, excludes a one-time adjustment of an acceleration of amortization expense for our IDgenetix test from net loss. We use Adjusted Revenues, Adjusted Gross Margin, Adjusted EBITDA and Adjusted Net (Loss) Income per Share, Basic and Diluted, internally because we believe these metrics provide useful supplemental information in assessing our revenue and operating performance reported in accordance with GAAP, respectively. We believe that Adjusted Revenues, when used in conjunction with our test report volume information, facilitates investors' analysis of our current-period revenue performance and average selling price performance by excluding the effects of revenue adjustments related to test reports delivered in prior periods, since these adjustments may not be indicative of the current or future performance of our business. We believe that providing Adjusted Revenues may also help facilitate comparisons to our historical periods. Adjusted Gross Margin is calculated using Adjusted Revenues and therefore excludes the impact of revenue adjustments related to test reports delivered in prior periods, which we believe is useful to investors as described above. We further exclude acquisition-related intangible asset amortization in the calculation of Adjusted Gross Margin. We believe that excluding acquisition-related intangible asset amortization may facilitate gross margin comparisons to historical periods and may be useful in assessing current-period performance without regard to the historical accounting valuations of intangible assets, which are applicable only to tests we acquired rather than internally developed. Adjusted Net (Loss) Income per Share, Basic and Diluted, is calculated by excluding a one-time adjustment of an acceleration of amortization expense for our IDgenetix test from net loss. We believe that providing Adjusted Net (Loss) Income per Share, Basic and Diluted, may also help facilitate comparisons to our historical periods. We believe Adjusted EBITDA may enhance an evaluation of our operating performance because it excludes the impact of prior decisions made about capital investment, financing, investing and certain expenses we believe are not indicative of our ongoing performance. However, these non-GAAP financial measures may be different from non-GAAP financial measures used by other companies, even when the same or similarly titled terms are used to identify such measures, limiting their usefulness for comparative purposes. These non-GAAP financial measures are not meant to be considered in isolation or used as substitutes for net revenues, gross margin, net loss or net loss per share reported in accordance with GAAP; should be considered in conjunction with our financial information presented in accordance with GAAP; have no standardized meaning prescribed by GAAP; are unaudited; and are not prepared under any comprehensive set of accounting rules or principles. In addition, from time to time in the future, there may be other items that we may exclude for purposes of these non-GAAP financial measures, and we may in the future cease to exclude items that we have historically excluded for purposes of these non-GAAP financial measures. Likewise, we may determine to modify the nature of adjustments to arrive at these non-GAAP financial measures. Because of the non-standardized definitions of non-GAAP financial measures, the non-GAAP financial measure as used by us in this press release and the accompanying reconciliation tables have limits in their usefulness to investors and may be calculated differently from, and therefore may not be directly comparable to, similarly titled measures used by other companies. Accordingly, investors should not place undue reliance on non-GAAP financial measures. Reconciliations of these non-GAAP financial measures to the most directly comparable GAAP financial measures are presented in the tables at the end of this release. About Castle BiosciencesCastle Biosciences (Nasdaq: CSTL) is a leading diagnostics company improving health through innovative tests that guide patient care. With a primary focus in dermatologic and gastroenterological disease, we develop personalized, clinically actionable solutions that help improve disease management and patient outcomes. We put people first—empowering patients and clinicians and informing care decisions through rigorous science and advanced molecular tests that support more confident treatment planning. To learn more, visit www.CastleBiosciences.com and connect with us on LinkedIn, Facebook, X and Instagram. DecisionDx-Melanoma, DecisionDx-CMSeq, i31-SLNB, i31-ROR, DecisionDx-SCC, MyPath Melanoma, AdvanceAD-Tx, TissueCypher, Esopredict, DecisionDx-UM, DecisionDx-PRAME and DecisionDx-UMSeq are trademarks of Castle Biosciences, Inc. Forward-Looking Statements This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are subject to the "safe harbor" created by those sections. These forward-looking statements include, but are not limited to, statements concerning our expectations regarding: Castle's 2026 total revenue guidance of $365-375 million; expectations for achieving positive Adjusted EBITDA in future periods; continued top-line performance and growth of test volumes; the ability of DecisionDx-Melanoma, DecisionDx-SCC, TissueCypher and AdvanceAD-Tx to bring substantial added value to clinicians and their patients; the ability of DecisionDx-Melanoma to support more informed SLNB decision-making for patients with CM; the ability of TissueCypher to (i) predict a patient's five-year risk of progression from BE and (ii) help clinicians tailor management decisions based on an individual patient's risk profile; the ability of AdvanceAD-Tx to guide systemic treatment decision making in patients with AD; Castle's expectations with respect to DETECT-AD, including the timing and results of the study; and Castle's ability to achieve near- and long-term success and the continued growth of our portfolio. The words "anticipate," "believe," "can," "could," "expect," "goal," "guidance," "may," "plan," "potentially," "providing," "upcoming," "will" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. We may not actually achieve the plans, intentions, or expectations disclosed in our forward-looking statements and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that we make. These forward-looking statements involve risks and uncertainties that could cause our actual results to differ materially from those in the forward-looking statements, including, without limitation: our assumptions or expectations regarding reimbursement for our products and subsequent coverage decisions; our estimated total addressable markets for our products and product candidates and the related expenses, capital requirements and potential needs for additional financing; the anticipated cost, timing and success of our product candidates; our plans to research, develop and commercialize new tests; our ability to successfully integrate new businesses, assets, products or technologies acquired through acquisitions; the effects of macroeconomic events and conditions, including inflation and monetary supply shifts, labor shortages, liquidity concerns at, and failures of, banks and other financial institutions or other disruptions in the banking system or financing markets, recession risks, supply chain disruptions, tariffs, outbreaks of contagious diseases and geopolitical events (such as the ongoing conflicts in the Middle East and Ukraine-Russia conflict), among others, on our business and our efforts to address any impact on our business; the possibility that subsequent study or trial results and findings may contradict earlier study or trial results and findings or may not support the results discussed in this press release, including with respect to the tests discussed in this press release; our planned installation of additional equipment and supporting technology infrastructures and implementation of certain process efficiencies may not enable us to increase the future scalability of our TissueCypher Test; the possibility that actual application of our tests may not provide the aforementioned benefits to patients; the possibility that our newer gastroenterology franchise may not contribute to the achievement of our long-term financial targets as anticipated; and the risks set forth under the heading "Risk Factors" in our Annual Report on Form 10-K for the year ended December 31, 2025 and our Quarterly Reports on Form 10-Q for the quarters ended March 31, 2026 and June 30, 2026, each filed or to be filed with the SEC, and in our other filings with the SEC. The forward-looking statements are applicable only as of the date on which they are made, and we do not assume any obligation to update any forward-looking statements, except as may be required by law. Investor Relations Contact:Camilla [email protected] Media Contact: Allison [email protected] The table below presents the reconciliation of Adjusted EBITDA, which is a non-GAAP financial measure. See "Use of Non-GAAP Financial Measures (UNAUDITED)" above for further information regarding the Company's use of non-GAAP financial measures. View original content to download multimedia:https://www.prnewswire.com/news-releases/castle-biosciences-reports-second-quarter-2026-results-302837723.html

Interested in Castle Biosciences, Inc.? Here are five stocks we like better. Castle Biosciences reported strong Q2 growth, with revenue rising 20% year over year to $103.5 million. The company raised its 2026 revenue outlook to $365 million–$375 million, up from $345 million–$355 million previously. TissueCypher was the primary growth driver, generating 14,988 reports, up 63% year over year. Castle now expects TissueCypher report volume to increase approximately 50%–52% in 2026, while AdvanceAD-Tx exceeded 1,000 orders in the quarter. Despite higher revenue, gross margins declined and Castle posted a $2.1 million net loss, although adjusted EBITDA rose to $12.4 million. Management expects positive adjusted EBITDA in Q3, Q4 and for full-year 2026, supported by $266.8 million in cash and investments at quarter-end. Castle Biosciences (NASDAQ:CSTL) reported second-quarter 2026 revenue of $103.5 million, up 20% from the prior-year period, as growth in its TissueCypher test and other core offerings supported results. The company raised its full-year revenue outlook to $365 million to $375 million, from a previous range of $345 million to $355 million. Founder, President and Chief Executive Officer Derek Maetzold said revenue growth excluding DecisionDx-SCC and IDgenetix was 40% year over year, while test report volume for the company’s core revenue drivers increased 32%. → Why SK hynix Could Be the Best AI Chip Stock to Buy Now “Our strong second quarter results reflect the continued execution of our growth strategy,” Maetzold said, citing investments in commercial resources, clinical evidence development, pipeline programs and laboratory capacity. TissueCypher, Castle’s test for patients with Barrett’s esophagus, generated 14,988 test reports during the quarter, representing 63% growth from the second quarter of 2025. Management said it now expects full-year 2026 TissueCypher report volume growth of approximately 50% to 52% compared with 2025. → 3 Value ETFs to Consider as Growth Stocks Lag Behind Chief Financial Officer Frank Stokes said revenue also benefited from some improvement in average selling price, partly reflecting changes to the company’s accrual processes implemented earlier in the year. However, he said investors should not expect another comparable step-up in pricing during the second half. Stokes said the company views TissueCypher’s performance on a multi-quarter trend rather than quarter-to-quarter changes. The company reported lower upper-endoscopy procedure levels during the first quarter, while it expects procedure volumes may have increased in the second quarter. → 5 AI Stocks Are Pulling Back—Which Growth Catalysts Still Look Strongest? Castle said it has approximately 100 sales representatives or territories across its gastroenterology and dermatology divisions. Maetzold said the company believes its commercial infrastructure is near the level needed to support TissueCypher and dermatology opportunities, although the company added representatives last year and again late in the second quarter. During the call, Stokes said TissueCypher had reached an estimated 10% to 12% penetration of its addressable patient market exiting 2025 and could reach the mid-teens based on figures provided with the quarterly results. He said there remains substantial opportunity to educate physicians who have not yet been introduced to the test’s clinical use. DecisionDx-Melanoma delivered 10,280 test reports during the second quarter, up 3% from a year earlier and approximately 3% sequentially. Castle reiterated its expectation for mid- to high-single-digit volume growth for the full year. Maetzold said sequential growth was below the company’s typical seasonal pattern, in part because the dermatology commercial team has adapted customer calls to support three products: DecisionDx-Melanoma, DecisionDx-SCC and AdvanceAD-Tx. The company announced during the quarter that a prospective multicenter study found DecisionDx-Melanoma outperformed the Melanoma Institute Australia Nomogram in identifying patients at low and high risk of sentinel lymph node biopsy positivity. According to Maetzold, patients identified by the test as having a less than 5% predicted risk had an observed positivity rate of 2.6%, below the National Comprehensive Cancer Network’s 5% threshold for considering avoidance of the surgical procedure. Castle also reported a pickup in DecisionDx-SCC volumes. Maetzold attributed the improvement to clinical value recognized by existing customers, more working days in the second quarter and a limited return of sales-force promotional attention to the test. Regarding potential Medicare coverage for DecisionDx-SCC, Maetzold said the company had not provided public commentary on discussions with Medicare contractors and noted there is no defined timetable for reconsideration requests. He said Castle modeled a potential draft coverage decision in the second half of 2026, which, if positive, could be followed by regained coverage roughly a year later. Castle said it received more than 1,000 AdvanceAD-Tx orders in the second quarter. The test is designed to guide systemic treatment selection for patients age 12 and older with moderate-to-severe atopic dermatitis. The company highlighted AdvanceAD-Tx receiving a Genomics Innovation Award in the MedTech Breakthrough Awards program. It also cited an independent real-world clinical utility study presented in June, in which 54.3% of patients receiving baseline systemic therapy were initially on treatment aligned with their molecular profile. Following AdvanceAD-Tx testing, 97.8% of patients were initiated on molecularly concordant systemic therapy, according to the company. Maetzold said Castle is seeing both new ordering clinicians and repeat users of AdvanceAD-Tx, with few clinicians appearing to be “one and done” users. The company is managing the rollout through its dermatology commercial organization, which remains primarily focused on melanoma. Management said approximately 80% to 85% of field-force call focus, commissions and bonus structure remains tied to melanoma, with the remainder weighted toward atopic dermatitis and SCC. Castle is also awaiting the Centers for Medicare & Medicaid Services’ preliminary 2026 Clinical Laboratory Fee Schedule rates following a panel’s unanimous recommendation to crosswalk AdvanceAD-Tx to an existing psoriasis drug-response test code. Maetzold said the recommended rate of $36.75 was “a very, very strong rate” for the test. He said preliminary draft rates are expected in late September. Second-quarter gross margin was 74.9%, compared with 77.3% a year earlier. Adjusted gross margin, excluding acquisition-related intangible amortization and certain prior-period revenue adjustments, was 76.3%, down from 79.5% in the prior-year quarter. Castle maintained its expectation for adjusted gross margin in the low- to mid-70% range for the full year. Total operating expenses, including cost of sales, rose to $106.6 million from $90.4 million a year earlier. The increase reflected higher personnel costs, laboratory supplies and services, commercial travel and administration expenses, as well as increased clinical trial, advisory board and travel costs for pipeline initiatives. Sales and marketing expense increased to $40.9 million from $35.1 million. General and administrative expense increased to $25.2 million from $22.9 million. Research and development expense increased to $14.5 million from $12.8 million. Cost of sales rose to $23.7 million from $17.6 million. Castle reported a net loss of $2.1 million, or $0.07 per diluted share, compared with net income of $4.5 million, or $0.15 per diluted share, in the second quarter of 2025. Adjusted EBITDA increased to $12.4 million from $10.4 million. The company said it expects positive adjusted EBITDA in the third and fourth quarters and for full-year 2026, as well as for full-year 2027 absent a strategic change in direction. As of June 30, Castle had $266.8 million in cash equivalents and marketable investment securities. Castle Biosciences, Inc is a molecular diagnostics company specializing in the development and commercialization of prognostic and diagnostic tests for patients with dermatologic conditions. The company's proprietary portfolio of genomic assays is designed to improve risk assessment and guide clinical decision-making for individuals with skin cancers and other skin-related diseases. By combining genomic data with advanced statistical algorithms, Castle Biosciences seeks to provide actionable insights that help physicians tailor treatment plans and monitoring strategies. The company's flagship test, DecisionDx-Melanoma, evaluates the probability of metastasis in patients diagnosed with cutaneous melanoma, supporting more personalized surveillance and therapeutic approaches. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "Castle Biosciences Q2 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for July 2026.

Q1 revenue was $83.7 million with core test report volumes up ~36% year‑over‑year, and management raised full‑year 2026 revenue guidance to $345–$355 million. DecisionDx‑Melanoma delivered 10,021 reports (+16% YoY) with March a record month but management still expects mid‑ to high‑single‑digit volume growth for 2026, while TissueCypher reports rose 58% YoY (11,745 reports) and the company expects ~50% YoY growth for the year despite seasonal Q1 softness. Financials and pipeline: gross margin rebounded to 72.8% (adjusted 75.6%), net loss narrowed to $14.5 million and adjusted EBITDA was negative $5.1 million, with cash and marketable securities of $261.7 million; the limited‑access AdvanceAD‑Tx launch saw ~650 Q1 orders and reimbursement clarity is expected by end‑Q3 2026. Interested in Castle Biosciences, Inc.? Here are five stocks we like better. Castle Biosciences (NASDAQ:CSTL) reported first-quarter 2026 revenue of $83.7 million, supported by continued growth in what management described as its “core revenue drivers,” DecisionDx-Melanoma and TissueCypher. Founder, President and CEO Derek Maetzold said test report volumes for the company’s core revenue drivers increased 36% year over year, and he added that excluding DecisionDx-SCC and IDgenetix revenue, first-quarter 2026 revenue growth was approximately 42% versus the first quarter of 2025. On the back of the quarter’s performance, management raised its full-year 2026 revenue outlook to $345 million to $355 million, up from prior guidance of $340 million to $350 million. → The Real SpaceX Play: 5 Chip Stocks Powering the IPO Before It Launches Maetzold said Castle delivered 10,021 DecisionDx-Melanoma test reports in the first quarter, representing 16% year-over-year growth, and noted that March 2026 was an “all-time high record month” for reports delivered. Despite the first-quarter performance, management reiterated expectations for “mid to high single-digit volume growth for the full year 2026.” In response to an analyst question about phasing, Maetzold said the first quarter benefited from an “easier comp” than the remainder of the year. → Tyson Foods' Total Returns: Tasty Treats for Income Investors? Maetzold also highlighted recent clinical evidence presented at the 2026 American Academy of Dermatology annual meeting. He said new data from 1,868 SEER-linked patients showed the DecisionDx-Melanoma test “significantly stratifies five-year melanoma-specific survival within AJCC stages and T categories,” helping identify patients whose mortality risk is “substantially higher or lower than staging alone would predict.” Maetzold referenced additional evidence from a prospective multicenter study evaluating DecisionDx-Melanoma’s i31-SLNB result, stating the study again confirmed the test identifies patients with a “less than 5% predicted risk” consistent with NCCN guideline thresholds while “outperforming traditional staging criteria.” → Berkshire Hathaway’s Record Cash Hoard: Why and What's Next? During Q&A, Maetzold discussed clinician feedback related to NCCN guidelines and other publications. He said Castle continues to hear that clinicians do not understand what NCCN “sees” in a study the company views as having “failed to meet the 5% cut point,” adding that customers have suggested the situation appears “more political” than expected. He also pointed to a “Future Oncology” publication as reinforcement that Castle’s test “comfortably” gets below 5% predicted risk in patients who underwent sentinel lymph node biopsy and said outcomes were “extremely strong” among patients who used the test to move away from SLNB. Separately, Maetzold said the company is “moving forward” with an FDA submission on the timeline it previously described, “sometime in 2026.” In gastroenterology, Castle delivered 11,745 TissueCypher test reports during the first quarter, up from 7,432 a year earlier, representing 58% growth, according to Maetzold. He said March was also an all-time record month for TissueCypher. Two studies presented at Digestive Disease Week by Mayo Clinic researchers were highlighted as well. Maetzold said the findings showed molecular risk stratification with TissueCypher refined risk assessment and “directly informed real-world management decisions” for Barrett’s esophagus patients. He added that one study showed surveillance interval changes in “more than half” of patients compared with histopathology-guided recommendations. Asked about a modest quarter-over-quarter decline in TissueCypher volume, CFO Frank Stokes attributed it to seasonality, saying the company has reached a penetration level where it is “seeing seasonality and feeling the sense of that.” Citing IQVIA third-party data, Stokes said the first quarter tends to have fewer GI procedures than other quarters. However, he noted March was a record month and said the trend “continued in April.” Looking ahead, management reiterated expectations to add a similar number of TissueCypher test reports in 2026 as in 2025, which Stokes said would imply “something close to a 50% year-over-year growth for the year.” Maetzold later told an analyst that “most” of the quarter’s revenue beat versus expectations was driven by TissueCypher. Maetzold described AdvanceAD-Tx, a test designed to guide systemic treatment selection for patients 12 and older with moderate to severe atopic dermatitis, as a midterm revenue driver for 2027 and 2028 alongside the company’s core drivers. He said the test was released under a limited access program in mid-fourth quarter 2025 and received approximately 650 orders during the first quarter of 2026. According to Maetzold, initial feedback indicates clinicians appreciate that the test integrates into existing atopic dermatitis care pathways, helping inform systemic therapy choices early in the treatment journey. He also pointed to a prospective multicenter clinical validation study published in the Journal of the American Academy of Dermatology, stating it showed AdvanceAD-Tx can identify patients more likely to achieve “greater and faster responses” with a JAK inhibitor compared with a Th2 biologic therapy. On reimbursement, Maetzold said Castle expects to be able to provide “more detail on reimbursement by the end of the third quarter of 2026,” citing long revenue cycle timelines. In Q&A, he added that by the end of the third quarter the company expects to provide “good evidence-based clarity” on what it can assume for 2027 and 2028 “under a traditional reimbursement approach.” He also noted potential alternative avenues, including interest from parties focused on reducing costs associated with cycling through medications and “an opportunity to potentially partner with some of these pharmaceutical companies.” When asked about expanding the initial rollout beyond targeted accounts, Maetzold said the company opened access “a bit more” late in the first quarter and plans to monitor early volume and reimbursement cycle assumptions before continuing a broader release. He described the 650 first-quarter orders as “very, very nice reinforcement” given that the field force remains focused on melanoma and access to the customer base is still limited. He also characterized AdvanceAD-Tx as a “pretty efficient” PCR-based test and said he would not expect it to have a material impact on the company’s blended adjusted cost structure “in the next several quarters.” Stokes reported gross margin of 72.8% for the first quarter of 2026, compared with 49.2% a year ago. He noted the first quarter of 2025 gross margin reflected a one-time adjustment related to accelerated amortization expense of approximately $20.1 million. Adjusted gross margin was 75.6% for the quarter, compared with 81.2% for the same period last year. Total operating expenses, including cost of sales, were $102.1 million, down from $115.9 million in the first quarter of 2025. Stokes outlined several expense drivers: Sales and marketing expense rose to $41.0 million from $36.8 million, which Stokes attributed primarily to higher personnel costs and higher sales-related travel expenses tied to increased field activity. General and administrative expense increased to $23.9 million from $21.8 million, driven by higher personnel, IT-related costs, and travel, partially offset by lower professional fees. Cost of sales increased to $20.5 million from $16.4 million, reflecting higher lab supplies, lab services, personnel costs, and depreciation due to volume growth and laboratory expansion investments. R&D expense rose to $14.4 million from $12.6 million, driven by higher personnel and clinical studies costs. Net loss narrowed to $14.5 million from $25.8 million in the prior-year quarter, and diluted loss per share was $0.49 compared with $0.90. Adjusted EBITDA was negative $5.1 million versus positive $13.0 million a year ago; Stokes said the year-over-year change “primarily reflects” a one-time, non-cash amortization expense recognized in 2025 related to accelerated amortization of the IDgenetix test. Stokes reported net cash used in operating activities of $22.1 million for the quarter, which he said was due in part to annual cash bonus payments and certain healthcare benefit payments that do not recur in the remaining quarters. Net cash used in investing activities was $25.8 million, driven primarily by purchases of marketable securities of $55.1 million and purchases of property and equipment, partially offset by maturities of marketable securities and the sale of equity securities. As of March 31, 2026, Castle had cash and cash equivalents and marketable securities of $261.7 million. On capacity, Maetzold addressed a question about relocating to a new Phoenix laboratory facility. He said the company has not made the change yet, and the move is intended to keep capacity “a couple of years ahead of demand,” particularly for expanding dermatology volumes. He said he does not expect “much impact” on gross margins from the shift. Stokes also said the company expects M&A to play a role in its growth story and will continue evaluating candidates that fit its strategic criteria, though he emphasized Castle does not feel compelled to pursue deals. “We don’t feel compelled to chase anything,” he said, adding that the company believes it has a “great opportunity with what we own and control today.” On commercial staffing, Maetzold said the company believes it can cover its dermatology and GI verticals “with fewer than 100 reps,” and that is where it stands currently. Castle Biosciences, Inc is a molecular diagnostics company specializing in the development and commercialization of prognostic and diagnostic tests for patients with dermatologic conditions. The company's proprietary portfolio of genomic assays is designed to improve risk assessment and guide clinical decision-making for individuals with skin cancers and other skin-related diseases. By combining genomic data with advanced statistical algorithms, Castle Biosciences seeks to provide actionable insights that help physicians tailor treatment plans and monitoring strategies. The company's flagship test, DecisionDx-Melanoma, evaluates the probability of metastasis in patients diagnosed with cutaneous melanoma, supporting more personalized surveillance and therapeutic approaches. The article "Castle Biosciences Q1 Earnings Call Highlights" was originally published by MarketBeat.

Revenue growth of 42% (excluding SCC and ID Genetics) was primarily driven by double-digit volume increases in core DecisionDx-Melanoma and TissueCypher tests. DecisionDx-Melanoma achieved record monthly test reports in March 2026, supported by new SEER-linked data demonstrating improved risk prediction over traditional AJCC staging. TissueCypher volume grew 58% year-over-year, though management noted that the franchise has reached a penetration level where first-quarter seasonality in GI procedures is now observable. The company is successfully transitioning to a multi-vertical growth strategy, with the gastroenterology franchise contributing significantly to the quarterly revenue beat. While total operating expenses decreased year-over-year, costs in specific areas like sales and marketing, G&A, and cost of sales increased due to strategic headcount expansion and laboratory facility investments to support higher test volumes. Management attributes the durability of the melanoma franchise to robust clinical evidence that aligns with NCCN guideline thresholds for surgical decision-making. Full-year 2026 revenue guidance was raised to $345 million–$355 million, reflecting strong execution and momentum in the core dermatology and GI portfolios. DecisionDx-Melanoma is expected to maintain mid to high single-digit volume growth for the full year, despite tougher year-over-year comparisons in subsequent quarters. TissueCypher is projected to add a similar number of total test reports in 2026 as it did in 2025, implying full-year growth approaching 50%. Management expects to provide clarity on the reimbursement landscape for the Advanced ADTx test by the end of the third quarter 2026 based on revenue cycle timelines. The company remains on track for an FDA submission for its melanoma test sometime in 2026 following its previous Breakthrough designation. The company is relocating to an expanded laboratory facility in Phoenix to stay ahead of anticipated demand capacity for the dermatology franchise. Uncertainty remains regarding Medicare coverage for DecisionDx-SCC; management does not expect a draft Local Coverage Determination (LCD) until the second half of 2026. Net cash used in operating activities of $22.1 million included non-recurring annual bonus and healthcare benefit payments typical for the first quarter. M&A remains a strategic consideration, though management emphasized a disciplined 'Goldilocks' approach, stating they do not feel compelled to chase targets. Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Management explained the modest quarter-over-quarter decline as a result of reaching a penetration level where seasonal fluctuations in GI procedures become visible. They emphasized that March was a record month and the positive trend continued into April, supporting a ratable ramp for the remainder of the year. The company is currently relying on traditional governmental and private payer reimbursement but is also exploring partnerships with commercial companies interested in shifting market share. Management expects to provide evidence-based clarity on reimbursement progress by the end of Q3 2026. Derek Maetzold noted that clinicians are questioning recent NCCN stances, viewing them as potentially political rather than data-driven. Recent publications in Future Oncology showing 97-98% recurrence-free survival for certain patients have reinforced clinician confidence in using the tests to guide surgical decisions. There has been no official update from Novitas or MolDx since the previous earnings call. Management believes the current year-plus review cycle is sufficient and expects a draft LCD posting in the second half of the year. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here.

Delivered Q1 2026 revenue of $83.7 million Q1 2026 total test reports for our core revenue drivers (DecisionDx®-Melanoma, TissueCypher®) increased 36% over Q1 2025 Raising full-year 2026 revenue guidance to $345-355 million from $340-350 million Conference call and webcast today at 4:30 p.m. ET FRIENDSWOOD, Texas, May 6, 2026 /PRNewswire/ -- Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, today announced its financial results for the first quarter ended March 31, 2026. "The Castle Biosciences team delivered outstanding results to start 2026, delivering $83.7 million in revenue," said Derek Maetzold, president and chief executive officer of Castle Biosciences. "I thank our team for their dedication and focus, which translates directly to our performance. Our momentum this quarter reflects our robust execution and the strength of our core revenue drivers, with both DecisionDx-Melanoma and TissueCypher achieving double digit year-over-year test volume growth, 16% and 58%, respectively. As a result of our first quarter performance and continued confidence in the business, we are raising our 2026 total revenue guidance to $345-355 million, compared to the previously provided guidance of $340-350 million. "In addition, during the quarter we expanded the body of evidence supporting our market-leading DecisionDx-Melanoma test. Specifically, we announced new data from a prospective, multicenter, U.S. based study demonstrating that patients with a less than 5% predicted risk of sentinel lymph node positivity had an actual positivity rate of just 2.6%, reinforcing DecisionDx-Melanoma's ability to guide sentinel lymph node biopsy decision-making in line with guideline thresholds. Our substantial body of evidence is a key driver of adoption and an important differentiator for DecisionDx-Melanoma and our innovative test portfolio more broadly, reinforcing our position of strength as we continue to execute across the business." First Quarter Ended Mar. 31, 2026, Financial and Operational Highlights Revenues were $83.7 million, compared to $88.0 million in the first quarter of 2025. Affecting first quarter 2026 revenue was the change in DecisionDx-SCC Medicare coverage effective April 24, 2025, the re-focus of our commercial efforts, as well as the discontinuation of IDgenetix in May 2025. Revenues for our non-dermatologic tests were $42.6 million, compared to $25.0 million during the same period in 2025. Core revenue drivers: First quarter 2026 total test reports for our core revenue drivers (DecisionDx-Melanoma, TissueCypher) increased 36% over the first quarter of 2025: DecisionDx-Melanoma test reports delivered in the quarter were 10,021, compared to 8,621 in the first quarter of 2025. TissueCypher Barrett's Esophagus test reports delivered in the quarter were 11,745, compared to 7,432 in the first quarter of 2025. Additional tests: DecisionDx-SCC test reports delivered in the quarter were 3,702, compared to 4,375 in the first quarter of 2025. MyPath® Melanoma test reports delivered in the quarter were 973, compared to 926 in the first quarter of 2025. DecisionDx®-UM test reports delivered in the quarter were 492, compared to 470 in the first quarter of 2025. Gross margin was 73%, and Adjusted Gross Margin was 76%, compared to 49% and 81%, respectively, for the same periods in 2025. Affecting first quarter 2025 gross margin was the one-time adjustment of an acceleration of amortization expense of approximately $20.1 million. Net cash used in operations was $22.1 million, compared to net cash used in operations of $6.0 million for the same period in 2025. First quarter 2026 cash use reflects payout of employee annual cash bonuses as well as certain health care benefit payments, totaling $28.8 million, that are not expected to recur during the remainder of 2026. Net loss, which includes non-cash stock-based compensation expense of $9.8 million, was $14.5 million, compared to net loss of $25.8 million for the same period in 2025. Net loss per share, Basic and Diluted, was $0.49, compared to net loss per share, Basic and Diluted of $0.90 and Adjusted Net Loss per Share, Basic and Diluted, of $0.20, for the same period in 2025. Adjusted EBITDA was $(5.1) million, compared to $13.0 million for the same period in 2025. Cash, Cash Equivalents and Marketable Investment Securities As of Mar. 31, 2026, the Company's cash, cash equivalents and marketable investment securities totaled $261.7 million. 2026 Outlook Castle Biosciences is raising its guidance for anticipated total revenue in 2026. The Company now anticipates generating between $345-355 million in total revenue in 2026, compared to the previously provided guidance of between $340-350 million. First Quarter and Recent Accomplishments and Highlights Dermatology - Skin Cancer The Company presented new data at the 2026 American Academy of Dermatology Annual Meeting demonstrating that its DecisionDx-Melanoma test refines mortality risk within American Joint Committee on Cancer (AJCC) stages for patients with cutaneous melanoma (CM). The data showed that DecisionDx-Melanoma identifies clinically meaningful differences in mortality risk among patients within the same stage, which may help clinicians more confidently escalate care for higher-risk patients while avoiding unnecessary interventions in those at lower risk of poor outcomes. See the Company's news release from March 27, 2026, for more information. The Company also announced new data from a prospective, multicenter study evaluating DecisionDx-Melanoma's integrated sentinel lymph node biopsy (i31-SLNB) test result. The study data confirmed that the i31-SLNB accurately predicts SLN positivity and identifies low-risk patients who may safely consider forgoing SLNB while maintaining favorable long-term outcomes. These results expanded upon earlier publications from the same prospective, multicenter clinical study and further strengthened the growing body of evidence supporting the role of DecisionDx-Melanoma in guiding SLNB decision-making. The paper, available in Future Oncology, confirmed that DecisionDx-Melanoma's i31-SLNB identifies patients below the 5% National Comprehensive Cancer Network® (NCCN) threshold for forgoing sentinel lymph node biopsy and outperforms traditional staging criteria and other predictive gene expression profile (GEP) tests. See the Company's news release from March 9, 2026, for more information. The Company presented new data at the European Congress of Dermato-Oncology (EADO) Congress and the American College of Mohs Surgery (ACMS) Annual Meeting demonstrating that its DecisionDx-Melanoma test provides independent, personalized prognostic information beyond AJCC staging, identifying biologically high-risk patients—including those with thin and early-stage disease—and supporting more precise, risk-aligned clinical management. See the Company's news release from April 21, 2026, for more information. The Company is supporting a series of initiatives across the country during May in recognition of Skin Cancer Awareness Month, including advocacy walks, community skin cancer screenings and patient education programs in collaboration with leading patient advocacy organizations. These efforts are aimed at expanding access to early detection, education and community-based resources to help prevent skin cancer and improve patient outcomes. See the Company's news release from May 5, 2026, for more information. Gastroenterology The Company announced that new data from Mayo Clinic researchers, presented at Digestive Disease Week®, demonstrate that its TissueCypher test improves risk stratification and informs real-world management decisions for patients with Barrett's esophagus, including influencing surveillance intervals in more than half of patients and enabling more personalized, risk-aligned care. See the Company's news release from May 4, 2026, for more information. Dermatology - Atopic Dermatitis The Company announced the publication of a prospective, multicenter clinical validation study in the Journal of the American Academy of Dermatology (JAAD) demonstrating that its AdvanceAD-Tx test can identify patients with moderate-to-severe atopic dermatitis who are significantly more likely to achieve greater and faster clinical responses when treated with a Janus kinase inhibitor compared to T helper type 2-targeted therapies. See the Company's news release from February 19, 2026, for more information. Conference Call and Webcast Details Castle Biosciences will hold a conference call on Wednesday, May 6, 2026, at 4:30 p.m. Eastern time to discuss its first quarter 2026 results and provide a corporate update. A live webcast of the conference call can be accessed here: https://events.q4inc.com/attendee/621816679 or via the webcast link on the Investor Relations page of the Company's website, https://ir.castlebiosciences.com/overview/default.aspx. Please access the webcast at least 10 minutes before the conference call start time. An archive of the webcast will be available on the Company's website until May 27, 2026. There will be a brief Question & Answer session following management commentary. Use of Non-GAAP Financial Measures (UNAUDITED) In this release, we use the metrics of Adjusted Revenues, Adjusted Gross Margin, Adjusted EBITDA and Adjusted Net Loss per Share, Basic and Diluted, which are non-GAAP financial measures and are not calculated in accordance with generally accepted accounting principles in the United States (GAAP). Adjusted Revenues and Adjusted Gross Margin reflect adjustments to GAAP net revenues to exclude net positive and/or net negative revenue adjustments recorded in the current period associated with changes in estimated variable consideration related to test reports delivered in previous periods. Adjusted Gross Margin further excludes acquisition-related intangible asset amortization. Adjusted EBITDA excludes from net loss: interest income, interest expense, income tax benefit or expense, depreciation and amortization expense, stock-based compensation expense and net (gains) losses on equity securities. Adjusted Net Loss per Share, Basic and Diluted, excludes a one-time adjustment of an acceleration of amortization expense for our IDgenetix test from net loss. We use Adjusted Revenues, Adjusted Gross Margin, Adjusted EBITDA and Adjusted Net Loss per Share, Basic and Diluted, internally because we believe these metrics provide useful supplemental information in assessing our revenue and operating performance reported in accordance with GAAP, respectively. We believe that Adjusted Revenues, when used in conjunction with our test report volume information, facilitates investors' analysis of our current-period revenue performance and average selling price performance by excluding the effects of revenue adjustments related to test reports delivered in prior periods, since these adjustments may not be indicative of the current or future performance of our business. We believe that providing Adjusted Revenues may also help facilitate comparisons to our historical periods. Adjusted Gross Margin is calculated using Adjusted Revenues and therefore excludes the impact of revenue adjustments related to test reports delivered in prior periods, which we believe is useful to investors as described above. We further exclude acquisition-related intangible asset amortization in the calculation of Adjusted Gross Margin. We believe that excluding acquisition-related intangible asset amortization may facilitate gross margin comparisons to historical periods and may be useful in assessing current-period performance without regard to the historical accounting valuations of intangible assets, which are applicable only to tests we acquired rather than internally developed. Adjusted Net Loss per Share, Basic and Diluted, is calculated by excluding a one-time adjustment of an acceleration of amortization expense for our IDgenetix test from net loss. We believe that providing Adjusted Net Loss per Share, Basic and Diluted, may also help facilitate comparisons to our historical periods. We believe Adjusted EBITDA may enhance an evaluation of our operating performance because it excludes the impact of prior decisions made about capital investment, financing, investing and certain expenses we believe are not indicative of our ongoing performance. However, these non-GAAP financial measures may be different from non-GAAP financial measures used by other companies, even when the same or similarly titled terms are used to identify such measures, limiting their usefulness for comparative purposes. These non-GAAP financial measures are not meant to be considered in isolation or used as substitutes for net revenues, gross margin, net loss or net loss per share reported in accordance with GAAP; should be considered in conjunction with our financial information presented in accordance with GAAP; have no standardized meaning prescribed by GAAP; are unaudited; and are not prepared under any comprehensive set of accounting rules or principles. In addition, from time to time in the future, there may be other items that we may exclude for purposes of these non-GAAP financial measures, and we may in the future cease to exclude items that we have historically excluded for purposes of these non-GAAP financial measures. Likewise, we may determine to modify the nature of adjustments to arrive at these non-GAAP financial measures. Because of the non-standardized definitions of non-GAAP financial measures, the non-GAAP financial measure as used by us in this press release and the accompanying reconciliation tables have limits in their usefulness to investors and may be calculated differently from, and therefore may not be directly comparable to, similarly titled measures used by other companies. Accordingly, investors should not place undue reliance on non-GAAP financial measures. Reconciliations of these non-GAAP financial measures to the most directly comparable GAAP financial measures are presented in the tables at the end of this release. About Castle Biosciences Castle Biosciences (Nasdaq: CSTL) is a leading diagnostics company improving health through innovative tests that guide patient care. With a primary focus in dermatologic and gastroenterological disease, we develop personalized, clinically actionable solutions that help improve disease management and patient outcomes. We put people first—empowering patients and clinicians and informing care decisions through rigorous science and advanced molecular tests that support more confident treatment planning. To learn more, visit www.CastleBiosciences.com and connect with us on LinkedIn, Facebook, X and Instagram. DecisionDx-Melanoma, DecisionDx-CMSeq, i31-SLNB, i31-ROR, DecisionDx-SCC, MyPath Melanoma, AdvanceAD-Tx, TissueCypher, Esopredict, DecisionDx-UM, DecisionDx-PRAME and DecisionDx-UMSeq are trademarks of Castle Biosciences, Inc. Forward-Looking Statements This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are subject to the "safe harbor" created by those sections. These forward-looking statements include, but are not limited to, statements concerning our expectations regarding: Castle's 2026 total revenue guidance of $345-355 million; continued top-line performance and growth of test volumes; the ability of DecisionDx-Melanoma, DecisionDx-SCC, TissueCypher and AdvanceAD-Tx to bring substantial added value to clinicians and their patients; the ability of DecisionDx-Melanoma to (i) reduce mortality risk compared to untested patients, (ii) improve patient survival, (iii) provide clarity in overall risk beyond histology, and (iv) guide sentinel lymph node biopsy decision-making, including through the i31-SLNB test result, by accurately predicting SLN positivity and identifying low-risk patients who may safely consider forgoing SLNB; the ability of DecisionDx-SCC to (i) predict individual risk of metastasis, benefit from ART and risk of LR, (ii) provide comprehensive results to support tailored post-surgical management and treatment pathway recommendations and (iii) provide actionable decision points based on individual patient risk; the anticipated success of our launch of AdvanceAD-Tx; and Castle's ability to achieve near- and long-term success and the continued growth of our portfolio. The words "anticipate," "can," "could," "expect," "goal," "guidance," "may," "plan," "potentially," "providing," "upcoming" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. We may not actually achieve the plans, intentions, or expectations disclosed in our forward-looking statements and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that we make. These forward-looking statements involve risks and uncertainties that could cause our actual results to differ materially from those in the forward-looking statements, including, without limitation: our assumptions or expectations regarding reimbursement for our products and subsequent coverage decisions; our estimated total addressable markets for our products and product candidates and the related expenses, capital requirements and potential needs for additional financing; the anticipated cost, timing and success of our product candidates; our plans to research, develop and commercialize new tests; our ability to successfully integrate new businesses, assets, products or technologies acquired through acquisitions; the effects of macroeconomic events and conditions, including inflation and monetary supply shifts, labor shortages, liquidity concerns at, and failures of, banks and other financial institutions or other disruptions in the banking system or financing markets, recession risks, supply chain disruptions, tariffs, outbreaks of contagious diseases and geopolitical events (such as the ongoing conflicts in the Middle East and Ukraine-Russia conflict), among others, on our business and our efforts to address any impact on our business; the possibility that subsequent study or trial results and findings may contradict earlier study or trial results and findings or may not support the results discussed in this press release, including with respect to the tests discussed in this press release; our planned installation of additional equipment and supporting technology infrastructures and implementation of certain process efficiencies may not enable us to increase the future scalability of our TissueCypher Test; the possibility that actual application of our tests may not provide the aforementioned benefits to patients; the possibility that our newer gastroenterology franchise may not contribute to the achievement of our long-term financial targets as anticipated; and the risks set forth under the heading "Risk Factors" in our Annual Report on Form 10-K for the year ended December 31, 2025 and our Quarterly Report on Form 10-Q for the quarter ended March 31, 2026, each filed or to be filed with the SEC, and in our other filings with the SEC. The forward-looking statements are applicable only as of the date on which they are made, and we do not assume any obligation to update any forward-looking statements, except as may be required by law. The table below presents the reconciliation of Adjusted EBITDA, which is a non-GAAP financial measure. See "Use of Non-GAAP Financial Measures (UNAUDITED)" above for further information regarding the Company's use of non-GAAP financial measures. View original content to download multimedia:https://www.prnewswire.com/news-releases/castle-biosciences-reports-first-quarter-2026-results-302763284.html

Alkermes plc ALKS reported a loss of 40 cents per share for the first quarter of 2026, which was narrower than the Zacks Consensus Estimate of a loss of 57 cents. The company had recorded earnings of 13 cents per share in the year-ago quarter. The company reported total revenues of $392.9 million for the first quarter, which increased 28.2% from the year-ago quarter owing to higher product sales. The top line also beat the Zacks Consensus Estimate of $359 million. Owing to the better-than-expected first-quarter results, ALKS’ shares were up 6.1% yesterday. The stock has rallied 29.5% in the year-to-date period against the industry’s decline of 2.4%. Image Source: Zacks Investment Research Alkermes derives revenues from the net sales of its proprietary products — Vivitrol (alcohol and opioid dependence), Aristada (schizophrenia), Lybalvi (schizophrenia and bipolar I disorder) and newly acquired sleep disorder drug, Lumryz. The metric also includes manufacturing and/or royalty revenues on net sales of products commercialized by partners. Sales of the proprietary products portfolio grew 38.3% year over year to $338.1 million during the first quarter, driven by solid demand across the commercial portfolio. Sales of proprietary products were above management’s guided range of $300-$320 million. Vivitrol sales increased 11.3% year over year to $112.4 million in the reported quarter. The metric beat the Zacks Consensus Estimate of $103 million. Aristada sales increased 27.6% year over year to $93.8 million. The figure beat the Zacks Consensus Estimate of $78 million. Lybalvi generated sales of $92.4 million, up 32% year over year in the reported quarter, due to increased total prescriptions. Its sales beat the Zacks Consensus Estimate of $87 million. Lybalvi’s total prescriptions grew 21% year over year in the quarter. In February 2026, Alkermes completed the previously announced acquisition of Ireland-based Avadel Pharmaceuticals, which added the latter’s FDA-approved product, Lumryz, to its commercial portfolio. Lumryz is approved as the first and only once-at-bedtime oxybate for extended-release oral suspension for the treatment of cataplexy or excessive daytime sleepiness in patients aged seven years and older with narcolepsy. Lumryz recorded revenues worth $39.5 million in the period from Feb. 12, 2026, to March 31, 2026. Total manufacturing and royalty revenues decreased around 11.6% year over year to $54.8 million. Manufacturing and royalty revenues from Biogen’s multiple sclerosis drug, Vumerity, were $27.3 million. Royalty revenues from Xeplion and certain Invega products were $18 million in the first quarter. Research and development expenses totaled $103.3 million, up around 43.9% year over year, owing primarily to higher costs related to the ongoing studies on pipeline candidate, alixorexton. Selling, general and administrative expenses totaled $264.6 million, up around 54.1% year over year, reflecting higher costs related to the acquisition of Avadel. As of March 31, 2026, Alkermes had cash and cash equivalents of $538.2 million compared with $1.32 billion as of Dec. 31, 2025. The company expects total revenues in the band of $1.73-$1.84 billion for 2026, unchanged from the previous expectation. Per management, total revenues are expected to be primarily driven by net sales of proprietary products, including Lumryz sales. Net sales of Vivitrol are expected to be in the band of $460-$480 million, while Aristada sales are anticipated in the range of $365-$385 million. Lybalvi’s net sales are expected in the $380-$400 million band. Net sales from the newly acquired sleep disorder drug, Lumryz, are expected to be in the range of $315-$335 million in 2026. Research and development expenses are anticipated in the range of $445-$485 million. Selling, general and administrative expenses are projected in the range of $890-$930 million. The company expects adjusted EBITDA to be in the range of $370-$410 million. Net sales from proprietary products are expected to be $385-$405 million for the second quarter of 2026. Alkermes is developing alixorexton, a novel, investigational, oral, selective orexin 2 receptor agonist for the treatment of narcolepsy type 1 (NT1) and narcolepsy type 2 (NT2) and idiopathic hypersomnia (IH). The company recently initiated the phase III Brilliance studies, evaluating the safety and efficacy of alixorexton versus placebo in adults with NT1 and NT2. The program consists of three 12-week, placebo-controlled phase III studies evaluating once-daily and split-dose regimens of alixorexton. Meanwhile, the phase II Vibrance-3 study continues to evaluate alixorexton for treating IH. Alkermes plc price-consensus-eps-surprise-chart | Alkermes plc Quote Alkermes currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech sector are Agenus AGEN, Castle Biosciences CSTL and Amarin AMRN, each currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here. Over the past 60 days, estimates for Agenus’ 2026 earnings per share have risen from 54 cents to $1.30, while loss per share estimates for 2027 have narrowed from $1.91 to $1.52 during the same time. AGEN shares have soared 32.8% year to date. Agenus’ earnings beat estimates in two of the trailing four quarters, while missing the same on the remaining two occasions, with the average surprise being 31.42%. Over the past 60 days, 2026 loss per share estimates for Castle Biosciences have narrowed from $1.42 to $1.40, while the same for 2027 have narrowed from 79 cents to 78 cents during the same time. CSTL stock has decreased 36.7% year to date. Castle Biosciences’ earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 34.69%. Over the past 60 days, 2026 loss per share estimates for Amarin have narrowed from $7.01 to $6.36, while the same for 2027 have narrowed from $5.50 to $4.64 during the same time. AMRN stock has increased 3.9% year to date. Amarin's earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 50.02%. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Alkermes plc (ALKS) : Free Stock Analysis Report Agenus Inc. (AGEN) : Free Stock Analysis Report Amarin Corporation PLC (AMRN) : Free Stock Analysis Report Castle Biosciences, Inc. (CSTL) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Krystal Biotech KRYS reported first-quarter 2026 earnings per share (EPS) of $1.83, which surpassed the Zacks Consensus Estimate of $1.45. The reported EPS was up from $1.20 in the year-ago quarter. Revenues of $116.4 million rose 32% year over year in the reported quarter, beating the Zacks Consensus Estimate of $112 million. Revenues came in solely from Vyjuvek sales. The FDA approved Krystal’s lead drug, Vyjuvek, the first-ever revocable gene therapy, in 2023 for the treatment of patients aged six months or older with dystrophic epidermolysis bullosa (DEB), a rare and severe monogenic disease that affects the skin and mucosal tissues. The drug has also been approved by the FDA for the treatment of DEB patients from birth, with authorization for at-home administration by patients or their caregivers. The company secured more than 695 reimbursement approvals for Vyjuvek in the United States, supporting nationwide access. Internationally, robust patient demand continues to drive steady uptake following the launches in Germany, France and Japan, with more than 140 patients being prescribed the therapy across these markets. Shares of KRYS rose nearly 8% on Monday, likely driven by the better-than-expected earnings results. Year to date, shares of KRYS have risen 16.4% against the industry’s 3.2% decline. Image Source: Zacks Investment Research The top line comprises product revenues from Krystal’s only marketed drug, Vyjuvek. Krystalgenerated $116.4 million in product revenues from Vyjuvek, up from $88.2 million in the year-ago quarter, driven by strong patient uptake. The gross margin in the reported quarter was 95%. Research and development (R&D) expenses were approximately $15.3 million, including stock-based compensation, up 7.5% year over year. Selling, general and administrative (SG&A) expenses totaled approximately $41 million, including stock-based compensation, up 25.6% from the year-ago level. This increase was primarily due to increased headcount, legal and consulting services, and marketing costs to support the global launches of Vyjuvek. As of March 31, 2026, cash, cash equivalents and investments totaled approximately $1 billion compared with $955.9 million as of Dec. 31, 2025. Krystal Biotech reiterated its non-GAAP combined R&D and SG&A expense guidance of $175 million to $195 million for full-year 2026. For Vyjuvek, pricing negotiations with reimbursement authorities remain ongoing in Germany and France and are expected to continue through at least the second half of 2026 and 2027, respectively. The company expects to launch the drug in Spain in the second half of 2026. Krystal is also advancing a robust clinical pipeline of investigational genetic medicines in the fields of respiratory, oncology, dermatology, ophthalmology and aesthetics. On the respiratory front, the company has two candidates in its pipeline — KB407 and KB408. The company is evaluating KB407 for the treatment of cystic fibrosis (CF). Based on discussions with the FDA, Krystal is initiating an open-label study to test repeat-dose KB407 in CF patients who cannot use or benefit from existing therapies. Patient enrollment is expected to be completed in the second quarter of 2026 and results are anticipated by the end of the year. Concurrently, Krystal is collaborating with the FDA and the Cystic Fibrosis Foundation on an innovative registrational study design that may use real-world patient data to support evaluation of KB407’s treatment effect. It plans to finalize and share the study design following FDA alignment in the second half of 2026, with the registrational study expected to begin in 2027. KB408 is being evaluated for the treatment of alpha-1 antitrypsin deficiency (AATD) lung disease. Enrollment is ongoing in repeat-dose Cohort 2B of the SERPENTINE-1 study, with interim results expected in 2026. In the ophthalmology space, another candidate, KB803, is being evaluated in IOLITE, a phase III randomized, placebo-controlled crossover study for the treatment and prevention of corneal abrasions in DEB patients. Patient enrollment has been completed, with top-line data anticipated in the fourth quarter of 2026. Krystal is also evaluating KB801 for the treatment of patients with neurotrophic keratitis (NK). A registrational, randomized, double-masked, placebo-controlled study, EMERALD-1, is evaluating the safety and tolerability of topical ocular administration of KB801 in patients with NK. Patient enrollment is currently ongoing and top-line data from the study is expected in 2026. On the oncology front, Krystal has a promising candidate, KB707, which is being developed for the treatment of solid lung tumors. Krystal is currently enrolling patients in the dose-expansion cohort of its phase I/II KYANITE-1 study, which is evaluating inhaled KB707 as monotherapy and in combination with chemotherapy in patients with advanced lung tumors. In the aesthetics space, the company’s wholly owned subsidiary, Jeune Aesthetics, is currently developing KB304 for the treatment of wrinkles of the décolleté. The company expects to initiate a mid-stage study in 2027. Krystal Biotech, Inc. price-consensus-eps-surprise-chart | Krystal Biotech, Inc. Quote Krystal Biotech currently carries a Zacks Rank #4 (Sell). Some better-ranked stocks in the biotech sector are Castle Biosciences (CSTL) and Indivior Pharmaceuticals INDV, each currently sporting a Zacks Rank #1 (Strong Buy) and Catalyst Pharmaceuticals CPRX, which carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here. Over the past 60 days, estimates for Castle Biosciences’ 2026 loss per share have narrowed from $1.42 to $1.40. Over the same period, loss per share estimates for 2027 have also narrowed from 79 cents to 78 cents. CSTL shares have lost 34.4% year to date. Castle Biosciences’ earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 34.69%. Over the past 60 days, estimates for Indivior Pharmaceuticals’ 2026 earnings per share have increased from $3.03 to $3.26. Over the same period, EPS estimates for 2027 have risen from $3.40 to $3.57. INDV shares have risen 8.6% year to date. Indivior Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 65.44%. Over the past 60 days, estimates for Catalyst Pharmaceuticals’ 2026 earnings per share have declined from $2.82 to $2.79. Over the same period, EPS estimates for 2027 have surged from $3.20 to $3.28. CPRX shares have gained 24% year to date. Catalyst Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 35.19%. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Catalyst Pharmaceuticals, Inc. (CPRX) : Free Stock Analysis Report Krystal Biotech, Inc. (KRYS) : Free Stock Analysis Report Castle Biosciences, Inc. (CSTL) : Free Stock Analysis Report Indivior Pharmaceuticals Inc. (INDV) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research