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CSTL

Castle BiosciencesF
Nasdaq / Health Care Equipment & Services
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2026-06-02
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2026-05-07
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Earnings documents stored for CSTL.

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Investor releaseQuarter not tagged2026-05-07

Castle Biosciences Q1 Earnings Call Highlights

MarketBeat

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 t...

Investor releaseQuarter not tagged2026-05-07

Castle Biosciences, Inc. Q1 2026 Earnings Call Summary

Moby

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 man...

Investor releaseQuarter not tagged2026-05-07

Castle Biosciences Reports First Quarter 2026 Results

PR Newswire

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 ou...

Investor releaseQuarter not tagged2026-05-07

Alkermes' Q1 Earnings & Revenues Beat Estimates, Stock Rises

Zacks

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 revenu...

Investor releaseQuarter not tagged2026-05-06

Krystal Biotech Q1 Earnings & Sales Beat Estimates, Pipeline in Focus

Zacks

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 r...

Investor releaseQuarter not tagged2026-05-06

BioMarin Q1 Earnings Miss, Sales Beat, '26 Revenue Guidance Raised

Zacks

BioMarin Pharmaceutical BMRN reported first-quarter 2026 adjusted earnings per share of 76 cents, missing the Zacks Consensus Estimate of 94 cents. However, earnings declined 33% year over year. This was largely due to a $31 million charge tied to the company’s unsuccessful campaign to extend Naglazyme manufacturing capabilities, as well as higher operating expenses associated with the acquisition of Amicus Therapeutics. Total revenues in the first quarter were $766.2 million, up 3% year over year. The figure beat the Zacks Consensus Estimate of $762.4 million. Shares of BioMarin were down in after-hours trading on Monday, likely due to the mixed earnings results. Year to date, the stock has lost about 7% compared with the industry’s 2% decline. Image Source: Zacks Investment Research Net product revenues totaled nearly $760.1 million, up 3.5% year over year on higher revenues from the company’s Enzyme Therapies, as well as Voxzogo. Royalty and other revenues totaled $6.1 million, down about 42% year over year. Voxzogo, approved for achondroplasia, generated sales of $220 million, up 3% year over year. Per the company, this modest upside was expected, as it had previously experienced large orders for the drug in the fourth quarter of 2025. Despite this, Voxzogo sales beat the Zacks Consensus Estimate of $216 million. BioMarin reports consolidated revenues from five products — Aldurazyme, Brineura, Naglazyme, Palynziq and Vimizim — under a single segment, “Enzyme Therapies.” Sales from this franchise increased 6% year over year to $514 million in the reported quarter, driven by higher product sales of Vimizim, Naglazyme and Brineura. Palynziq injection sales totaled $90 million in the quarter, down 3% year over year, impacted by order timing in the United States. The drug’s sales missed the Zacks Consensus Estimate of $112 million. Vimizim sales rose 12% year over year to $210 million, which beat the Zacks Consensus Estimate of $194 million. Naglazyme sales increased 14% year over year to $130 million. Brineura generated sales of $47 million, up 18%. Product revenues from Aldurazyme totaled $37 million, down 24% year over year. BioMarin signed a collaboration agreement with Sanofi’s SNY subsidiary, Genzyme, for Aldurazyme. SNY, through Genzyme, is BMRN’s sole customer for Aldurazyme. The Sanofi subsidiary is responsible for marketing and selling Aldurazyme to...

Investor releaseQuarter not tagged2026-05-06

Repligen's Q1 Earnings & Revenues Beat Estimates, Stock Rises

Zacks

Repligen Corporation RGEN reported first-quarter 2026 adjusted earnings per share of 48 cents, which beat the Zacks Consensus Estimate of 38 cents. In the year-ago quarter, the company reported adjusted earnings of 39 cents per share. Total revenues in the first quarter were $194.3 million, up 14.8% year over year on a reported basis. Excluding the impact of acquisition and currency exchange, revenues rose 11% organically. Revenues also beat the Zacks Consensus Estimate of $191 million. Shares of Repligen were up 6.3% yesterday owing to the better-than-expected results. However, the stock has lost 23.3% year to date, compared with the industry’s 2.4% decline. Image Source: Zacks Investment Research The company’s top line comprises product revenues and negligible royalties and other revenues. Product revenues were $194.2 million, up almost 14.8% from the year-ago level. Royalty and other revenues amounted to $0.04 million, up almost 26% year over year. Repligen records revenues from its business franchisees that can be categorized as filtration, chromatography, proteins and process analytics. Total orders remained strong, like some previous quarters, with all the franchises witnessing year-over-year growth during the first quarter. Filtration revenues grew mid-single digits on a reported basis in the quarter, driven by fluid management, ATF and other consumables. Chromatography revenues increased over 25% year over year during the quarter, driven by growth in OPUS columns. Consumables, including proteins, grew in double digits. Biopharma revenues also grew year over year during the first quarter, driven by growth from emerging biotech. CDMO revenues grew mid-teens year over year during the quarter. In the reported quarter, Process Analytics revenues grew more than 50% year over year, led by strength in the downstream analytics offering and overall strong demand. Adjusted gross margin was 55.5%, reflecting an increase of 180 basis points year over year. Adjusted operating income totaled $30 million, reflecting an increase of 30.4% year over year. Adjusted operating margin was 15.4% in the first quarter, higher than 13.8% in the year-ago quarter. As of March 31, 2026, Repligen had cash and cash equivalents worth $785 million compared with $768 million as of Dec. 31, 2025. Repligen lowered its full-year 2026 revenue guidance while increasing its EPS outlook. The...

Investor releaseQuarter not tagged2026-05-06

JAZZ Stock Jumps as Q1 Earnings & Sales Surpass Expectations

Zacks

Jazz Pharmaceuticals JAZZ reported first-quarter 2026 adjusted earnings per share (EPS) of $6.34, which beat the Zacks Consensus Estimate of $4.67. In the year-ago quarter, the company posted EPS of $1.68, which was significantly impacted by higher operating expenses. Total revenues rose 19% year over year to $1.07 billion, which beat the Zacks Consensus Estimate of $972 million. Shares of Jazz edged higher in after-hours trading yesterday, likely driven by the stronger-than-expected earnings performance. The stock also continued to rise in pre-market trading today. Year to date, Jazz stock has gained 25% against the industry’s 2% decline. Image Source: Zacks Investment Research Net product sales increased 22% year over year to $1.03 billion. The reported figure beat both the Zacks Consensus Estimate of $925 million and our model estimate of $924 million. Jazz recorded $36.3 million in royalty revenues from high-sodium oxybate authorized generic (AG), down about 26% year over year. Other royalties and contract revenues declined 23% to $7.3 million. Net product sales for the combined oxybate business (Xyrem + Xywav) rose 15% to $439.4 million. This combined figure beat both the Zacks Consensus Estimate of $390 million and our model estimates of $393 million. Sales of the sleep disorder drug Xyrem declined 16% year over year to $31.2 million due to patients switching to Xywav and the launch of AGs in 2023. Xywav, a low-sodium formulation of Xyrem, recorded sales of $408.2 million in the quarter, up 18%. This upside can be attributed to the encouraging uptake of the drug in narcolepsy and idiopathic hypersomnia indications. This drug is currently Jazz’s most extensive product by net sales. Sales of the epilepsy drug Epidiolex/Epidyolex rose 15% to $249.8 million, driven by continued strong demand. This metric also beat the Zacks Consensus Estimate of $238 million and our model estimate of $234 million. Oncology product sales rose 45% to $333.4 million. Chemotherapy drug Rylaze/Enrylaze posted sales of $103.7 million, up 10% year over year. This figure beat the Zacks Consensus Estimate and our model estimate, each pegged at $97 million. Zepzelca, approved for small-cell lung cancer (SCLC), recorded sales of $101 million, up 60% year over year. This upside was primarily driven by continued uptake of the drug in the recently approved front-line SCLC setting. Acute...

TranscriptFY2026 Q12026-05-06

FY2026 Q1 earnings call transcript

Earnings source - 62 paragraphs
Operator

Good afternoon, and welcome to Castle Biosciences first quarter 2026 conference call. As a reminder, today's call is being recorded. We will begin today's call with opening remarks and introductions, followed by a question-and-answer session. I would like to turn the call over to Camilla Zuckero, Vice President, Investor Relations and Corporate Affairs. Please go ahead.

Camilla Zuckero

Thank you, operator. Good afternoon, everyone. Welcome to Castle Biosciences first quarter 2026 results conference call. Joining me today are Castle's Founder, President, and Chief Executive Officer, Derek Maetzold, and Chief Financial Officer, Frank Stokes. Information recorded on this call speaks only as of today, May 6th, 2026. Therefore, if you're listening to the replay or reading the transcript of this call, any time-sensitive information may no longer be accurate. A recording of today's call will be available on the Investor Relations page of the company's website for approximately three weeks following the conclusion of the call.

Camilla Zuckero

Before we begin, I would like to remind you that some of the statements made today will contain forward-looking statements, including statements about expected addressable markets, statements containing projections regarding future events or our future financial or operational results and performance, including our anticipated 2026 total revenue and the impact our investments and growth initiatives, including our ability to achieve long-term growth and drive stockholder value. Forward-looking statements are based upon current expectations and involve inherent risks and uncertainties. There can be no assurances the results contemplated in these statements will be realized. A number of factors and risks could cause actual results to differ materially from those contained in these forward-looking statements. Please refer to the risk factors in our most recent SEC filings for more information.

Camilla Zuckero

These forward-looking statements speak only as of today, and we assume no obligation to update or revise these forward-looking statements as circumstances change. In addition, some of the information discussed today includes non-GAAP financial measures such as adjusted revenue, adjusted gross margin, and Adjusted EBITDA that have not been calculated in accordance with U.S. GAAP. Reconciliations of these non-GAAP financial measures to the most directly comparable GAAP financial measures are presented in the tables at the end of our earnings release issued earlier today, which has been posted on the Investor Relations page of the company's website. I will now turn the call over to Derek.

Derek Maetzold

Thank you, Camilla, and good afternoon, everyone. We delivered strong first quarter results building on our momentum from 2025. Thanks to the strong execution by the entire Castle team, we delivered revenue of $83.7 million. Test report volumes for our core revenue drivers grew 36% compared to the first quarter of 2025. Excluding DecisionDx-SCC and IDgenetix revenue, our revenue growth for the first quarter of 2026 is approximately 42% compared to the first quarter of 2025, highlighted by double-digit year-over-year test report volume growth for both DecisionDx-Melanoma and TissueCypher.

Derek Maetzold

Throughout the first quarter of 2026, our teams remain focused on executing our growth priorities, and our strong performance gives us confidence to raise our 2026 revenue outlook to between $345 million-$355 million, compared to our previous provided guidance of $340 million-$350 million. Now, I will walk you through business highlights from the first quarter, and then Frank will provide additional financial highlights before we turn to your questions. Let's start with our core revenue drivers and what we see as the bulk of our 2026 top-line growth story, DecisionDx-Melanoma and TissueCypher. For DecisionDx-Melanoma, we delivered 10,021 test reports in the first quarter, representing 16% year-over-year growth. Further, March of 2026 saw an all-time high record month for test reports delivered.

Derek Maetzold

We believe DecisionDx-Melanoma remains a durable growth driver and continue to expect mid to high single-digit volume growth for the full year 2026. Driving test adoption and sustaining our competitive advantage through robust clinical evidence remains a key priority. We recently presented new data at the 2026 American Academy of Dermatology annual meeting demonstrating that our DecisionDx-Melanoma test can significantly improve risk prediction within American Joint Committee on Cancer, or AJCC, stages for patients with cutaneous melanoma. These data from 1,868 SEER-linked patients showed that DecisionDx-Melanoma significantly stratifies five-year melanoma-specific survival within AJCC stages and T categories, identifying patients whose mortality risk is substantially higher or lower than staging alone would predict.

Derek Maetzold

What this means is that in this study, DecisionDx-Melanoma provided clinically meaningful differences in risk within the same stage, enabling more personalized risk-aligned management decisions by helping clinicians identify patients who may warrant closer monitoring or early intervention while also recognizing those who may safely be managed less intensively. These great results are in addition to our recently published data from the prospective multicenter study evaluating DecisionDx-Melanoma's i31-SLNB test result. Data from this prospective U.S.-based study confirmed again that our test identifies patients with a less than 5% predicted risk consistent with the National Comprehensive Cancer Network guideline thresholds while maintaining favorable outcomes and outperforming traditional staging criteria. Let's turn to our gastroenterology franchise.

Derek Maetzold

During the first quarter of 2026, we delivered 11,745 TissueCypher test reports compared to 7,432 in the first quarter of 2025, which is 58% growth. Consistent with our DecisionDx-Melanoma test in March, March also represented an all-time record month for TissueCypher. Two studies were recently presented at the Digestive Disease Week by researchers at the Mayo Clinic. The findings demonstrated how molecular risk stratification with a TissueCypher test refined risk assessment and directly informed real-world management decisions for patients with Barrett's esophagus, with one study showing changes in surveillance intervals in more than half of patients compared with recommendations guided by traditional histopathology alone, supporting more personalized, risk-aligned patient management. Look to our news release from earlier this month for more information on these studies.

Derek Maetzold

Looking to the full year, we expect to add a similar number of tests in 2026 as it is in 2025, indicating year-over-year growth approaching 50%. Let's move on to what we believe are our midterm, which we view as 2027 and 2028 revenue drivers, which includes our AdvanceAD-Tx test in addition to our core revenue drivers. As a reminder, AdvanceAD-Tx is our first-in-class test designed to guide systemic treatment selection for patients 12 years of age and older with moderate to severe atopic dermatitis or AD. You may recall that we released this test under a limited access program mid-fourth quarter of 2025. Continuing on our limited access during the first quarter, we received approximately 650 orders.

Derek Maetzold

Initial responses indicate that clinicians appreciate that AdvanceAD-Tx integrates into their existing AD care pathway, helping to make more informed systemic therapy choices early in the patient treatment journey. Supporting this claim, during the quarter, we published data from a prospective multicenter clinical validation study in the Journal of the American Academy of Dermatology demonstrating that AdvanceAD-Tx can identify patients with moderate to severe atopic dermatitis who are significantly more likely to achieve greater and faster responses when treated with a JAK inhibitor compared to a Th2 biological therapy.

Derek Maetzold

The data show that AdvanceAD-Tx can stratify patients by molecular profile, identifying those more likely to achieve near clear skin or EASI-90 faster time to response and meaningful patient-reported benefits when taking a JAK inhibitor, supporting improved outcomes and more biologically informed systemic treatment decisions early in the treatment journey with JAK inhibitor therapy as compared to Th2 targeted biologic therapy. Based on revenue cycle timelines, we expect to be in a position to provide more detail on reimbursement by the end of the third quarter of 2026. With that, I'll now turn the call over to Frank.

Frank Stokes

Thank you, Derek. Good afternoon, everyone. As Derek noted, our first quarter financial performance marks a strong start to 2026. Revenue was $83.7 million for the first quarter of 2026, driven by continued strength in our core revenue drivers. For total revenue for 2026, we are raising our revenue guidance to $345 million-$355 million, up from the previously provided range of $340 million-$350 million. This is growth of high teens to low 20%s in 2026 over 2025, excluding revenue from DecisionDx-SCC and IDgenetix from the 2025 and 2026 totals. Our gross margin during the first quarter of 2026 was 72.8% compared to 49.2% in the first quarter of 2025.

Frank Stokes

As a reminder, first quarter of 2025 gross margin reflects the one-time adjustment of an acceleration of amortization expense of approximately $20.1 million. Our adjusted gross margin, which excludes the effects of intangible asset amortization related to our acquisitions and excludes the effects of revenue adjustments in the current period associated with test reports delivered in prior periods, was 75.6% for the quarter, compared to 81.2% for the same quarter in 2025. Turning to expenses, our total operating expenses, including cost of sales for the first quarter of 2026, were $102.1 million compared to $115.9 million for the first quarter of 2025.

Frank Stokes

Sales and marketing expenses for the quarter were $41 million compared to $36.8 million for the same period in 2025, primarily driven by higher personnel costs and higher sales-related travel expenses. Increases in personnel costs reflect a higher headcount driven by sales force expansion as well as merit and annual inflationary wage adjustment for existing employees. Higher sales-related travel expenses reflect increased field activity to support growing test report volumes. General and administrative expenses were $23.9 million for the quarter, compared to $21.8 million for the same period in 2025, primarily attributable to higher personnel costs, higher information technology-related costs, and higher travel costs, partially offset by a decrease in professional fees. Increases in personnel costs reflect headcount expansions in our administrative support functions as well as merit and annual inflationary wage adjustment for existing employees.

Frank Stokes

Cost of sales expenses were $20.5 million in the first quarter of 2026 compared to $16.4 million in the first quarter of 2025, primarily due to higher expenses for lab supplies, higher lab services costs, higher personnel costs, and higher depreciation expense. The increase in expenses for lab supplies and lab services expense was driven by higher test report volumes. Increases in personnel costs reflect a higher headcount due to additions made to support business growth in response to growing test report volumes, as well as merit and annual inflationary wage adjustments for existing employees. The higher depreciation expense reflects continued investment in and expansion of our laboratory facilities.

Frank Stokes

R&D expenses were $14.4 million for the quarter, compared to $12.6 million for the same period in 2025, primarily due to higher personnel costs and higher clinical studies costs. The increases in personnel costs reflect a higher headcount to support continued business growth, and increases in clinical studies costs reflect investment in our pipeline products. Total non-cash stock-based compensation expense, which is allocated among cost of sales, R&D, and SG&A expense, was $9.8 million for the first quarter of 2026, compared to $11.2 million in the first quarter of 2025. Interest income was $2.5 million for the first quarter of 2026, compared to $3.1 million in the first quarter of 2025.

Frank Stokes

Our net loss for the first quarter of 2026 was $14.5 million, compared to a net loss of $25.8 million for the first quarter of 2025. Diluted loss per share for the first quarter was $0.49, compared to a diluted loss per share of $0.90 for the same period in 2025. Adjusted EBITDA for the first quarter was negative $5.1 million, compared to $13 million for the comparable period in 2025. The year-over-year change primarily reflects a one-time non-cash amortization expense recognized in 2025 related to the accelerated amortization of our IDgenetix test.

Frank Stokes

Net cash used in operating activities was $22.1 million for the first quarter of 2026, due in part to annual cash bonus payments and certain healthcare benefit payments that do not recur through the remaining three quarters of the year. Net cash used in investing activities was $25.8 million for the first quarter and consisted primarily of purchases of marketable investment securities of $55.1 million, purchases of property and equipment, partially offset by the maturities of marketable investment securities and the sale of equity securities. As of March 31st, 2026, we had cash and cash equivalents and marketable securities of $261.7 million. As we've discussed, we expect M&A to play a role in our growth story, and we intend to continue to evaluate candidates that fit within our strategic opportunities criteria.

Frank Stokes

In closing, I'm pleased with our strong first quarter results and increased guidance, which reflect the consistent execution and momentum we're building across the entire business. I'll now turn the call back over to Derek.

Derek Maetzold

Thank you, Frank. In summary, I am pleased with our strong start to 2026. We remain confident in our ability to execute our growth strategy and drive long-term value to our stockholders. Finally, I want to thank the entire Castle team, their dedication to advancing patient care and improving patients' lives. We're proud of our accomplishments and excited about the path ahead, and we look forward to sharing our continued progress in the coming quarters. Thank you for your continued interest in Castle Biosciences. Now, we will be happy to take your questions. Operator?

Operator

Thank you. In order to allow everyone in the queue an opportunity to address the Castle management team, please limit your time on the call to one question and only one follow-up. If you have additional questions, please return to the queue. If you would like to ask a question, please type star one on your telephone keypad to raise your hand. Please stand by while we compile the Q&A roster. Your first question comes from the line of Mason Carrico with Stephens. Your line is open. Please go ahead.

Mason Carrico

Hey, guys. Thanks for taking the questions here. I wanted to start out with TissueCypher volume, 58% growth year-over-year. Obviously, that's great growth. Volumes did decline very modestly quarter-over-quarter. That just hasn't happened since early 2024, I think. Any unique dynamics to call out in the quarter that may have contributed to that, whether seasonality, anything capacity-related? Just, I guess any color there would be great.

Frank Stokes

Yeah, sure, Mason. Thanks. You know, as you noted, we continue to see really strong growth there with 58% year-over-year growth. On the sequential or quarter-to-quarter trend there, you know, I think we finally have hit the penetration level where we are seeing seasonality and feeling the sense of that. Based on looking at IQVIA third-party data, historically, the first quarter of the year has fewer GI procedures than the other quarters. Having said that, importantly, you know, March was a record month for TC, and that trend continued in April. I think we would expect to add a similar number of test reports in 2026 as we did in 2025.

Frank Stokes

That gets us something close to a 50% year-over-year growth for the year. Good performance on the test and we continue to be pleased with what we're seeing.

Mason Carrico

Got it. Thanks, Frank. Could you guys update, or would you give us an update on the reimbursement initiatives for your AdvanceAD-Tx test or the progress you've made on that front? I guess as kind of a follow-up to that, on the potential for revenue to become material there in 2027 or 2028, where do you expect that revenue to come from? Is it all from appeals, or could there be some other revenue model contributing next year by 2028?

Derek Maetzold

Hi, Mason, Derek here. We think, based upon the long revenue cycles from an RCM perspective, we could be in a position probably by the end of the third quarter to provide some good evidence-based clarity in terms of what we're seeing, what we can assume for 2027, 2028 under a traditional reimbursement approach. There are, of course, other avenues as well in terms of interested parties who may be interested in controlling the cost of having patients keep cycling around medications. Of course, there's always an opportunity to potentially partner with some of these pharmaceutical companies who might have an interest in having their share shifted.

Derek Maetzold

For right now, I would say if we relied primarily on traditional governmental or private payer reimbursement probably end of third quarter so we can give some strong clarity based on evidence.

Operator

Your next question comes from the line of Thomas Flaten with Lake Street. Your line is open. Please go ahead.

Thomas Flaten

Yeah, good afternoon. I appreciate you taking the questions. I think you guys were relocating to a new Phoenix lab, at some point this year. Any update on what impact that might have on gross margins going forward?

Derek Maetzold

I don't think we'll see much impact on gross margins, Thomas. We haven't made that change yet. We're moving into an expanded facility in the Phoenix area. That's really an eye towards, as you recall from working with us for a while, we try to stay a couple of years ahead of demand in terms of capacity. As we look at the expanding Derm franchise and the growth in those test volumes in particular, we're trying to stay ahead of it. I don't have guidance for you on when we'll make that move, but I don't think you'll see much impact on gross margin at all as we shift from one facility to the other.

Thomas Flaten

Got it. On AdvanceAD-Tx, any thoughts on broadening this initial rollout? I think you had 150 accounts targeted as the first group. Will that stay at those 150 for the foreseeable future, at least until you have more visibility into reimbursement?

Derek Maetzold

We opened up access a bit more in this first quarter, of this late in the first quarter. We'll kind of look at our volume, look at our early RCM assumptions here, make sure we're on track, and then kind of continue to go ahead and release it over time. That being said, having 650 orders come in the door in the first quarter is very, very nice reinforcement of the opportunity that we have here when the field force is 100% focused on melanoma, and we have such limited access to our customer base. We are quite pleased with the continued early response of the dermatologic clinicians out there in the field.

Operator

Your next question comes from the line of Catherine Schulte with Baird. Your line is open. Please go ahead.

Catherine Schulte

Hi, guys. Thanks for the questions. Maybe first for the mid to high single-digit melanoma volume growth for the year, you know, off to a really strong start there with mid-teens growth in 1Q. You know, should that double-digit growth continue in the second quarter with some conservatism baked into the back half? How should we think about the phasing there?

Derek Maetzold

Yeah. We did reiterate, Catherine, our 2026 mid to high single-digit growth expectations. Q1 was a bit of an easier comp than we expect for the rest of the year. We're pleased with that, and I think that's where we see the business trending.

Catherine Schulte

Okay. I guess, have you guys been getting any feedback from clinicians regarding some of the moving pieces on NCCN guidelines and, you know, any feedback you've received on the Future Oncology publication or any other data that you've put out recently?

Derek Maetzold

We continue to get good feedback on, "I don't quite understand what NCCN sees here. This is a failed study, failed to meet the 5% cut point here, so what's trying to be said?" Which is good for us. I think unfortunately from an NCCN standpoint, there's a belief that this is really more political than we even thought, I guess you would say. We're hearing that from most of our customers. The side study which came out in Future Oncology earlier this year was another strong reinforcement that if you use our test to look at accuracy, once again, we have one more study showing that we comfortably get way below 5% predicted risk in people who actually underwent an SLNB.

Derek Maetzold

As important in that same publication is that people who used our test to move away from SLNB, meaning you didn't know if you were gonna be positive or negative, had extremely strong outcomes. I think it was 97.8% recurrence-free survival over the time period of the publication. That is a really safe melanoma patient, if you can, I guess, use those two words together, right? That continues to be strong reinforcement that we've got data that they can rely upon, that's consistent over time, which is excellent. I think that's what also led to having our greatest month ever in March of this year.

Operator

Your next question comes from the line of Subbu Nambi with Guggenheim. Your line is open. Please go ahead.

Speaker 10

Hi, guys. This is Thomas on for Subbu. Thanks for taking our questions. Frank, you mentioned M&A. Is that something you're looking at near-term? Can you just walk us through those factors you're considering when evaluating targets and your criteria there?

Frank Stokes

I mean, I think we always are open-eyed to what may be a possibility. We own things as we become aware of them. We don't feel compelled to chase anything. I think we've got a great opportunity with what we own and control today. You know, we do look at things as they come around or come across us. As you know, the Goldilocks approach is pretty tough. I mean, things have to look pretty good, but we do think that could be part of the future.

Speaker 10

Great. Separately on, maybe on Salesforce, can you just give an update today on Derm and GI? Then maybe how headcount expansion is expected to look for this year and how does that translate to selling and marketing spend? Thanks.

Derek Maetzold

Yeah, what we said is we think we can cover for the time being in the near term both of those verticals with fewer than 100 reps, and that's where we are today.

Operator

Your next question comes from the line of Matthew Parisi with KeyBanc Capital Markets. Your line is open. Please go ahead.

Matthew Parisi

Hi. Sorry, I was on mute. This is Matthew Parisi on for Paul Knight at KeyBanc Capital Markets. Congrats on the quarter, and thanks for taking my question. You previously mentioned in 2025 that melanoma received FDA breakthrough designation. I was wondering if Castle is still preparing for, like, an FDA submission in 2026 that you'd mentioned.

Derek Maetzold

We are moving forward with a submission along that same timeline, sometime in 2026 here, yes.

Matthew Parisi

All right, thank you. Just one other follow-up. Just wondering if there's been an update on SCC. I know you guys had received acceptance of the reconsideration requests for both Novitas and MolDX, and if there's just any update or an idea on timing.

Derek Maetzold

No, no official update, I guess, from either one of the Medicare contractors, Palmetto or Novitas since, I guess, our year-end earnings call a few weeks ago. We still continue to believe that that kind of a year-plus review cycle should be plenty of time for a reconsideration request that was accepted in, I guess, July and September accordingly between Novitas and MolDX. We aren't at this point in time thinking that there is a later posting of a draft LCD than sort of the second half of this year. That would be surprising.

Operator

Your next question comes from the line of Kyle Mikson with Canaccord. Your line is open. Please go ahead.

Kyle Mikson

Hey, guys. Thanks for the questions. This may have been covered, I apologize. On the 150 orders for the AdvanceAD-Tx test, could you just talk about, you know, recent trends and how you expect that to accelerate going forward? When you think about that number getting into the thousands, I guess, you know, in the relatively near term here, how does that affect the cost structure of the company, I guess? I know it's obviously not super material, but as we see gross margin decline, you know, sequentially and things like that, I'm just curious how we should be thinking about P&L impact.

Derek Maetzold

You're more about COGS impact or AdvanceAD-Tx? Kyle, I think that what we see right now the primary hurdle for our AdvanceAD-Tx is just our candidly our willingness to how available do we wanna make it. In terms of impacting the overall COGS profile, that's a pretty efficient test. It's a PCR-based test, even with some growth in volumes from where we were in Q1, we wouldn't expect a material impact on the blended adjusted COGS structure of the company, certainly in the next several quarters anyway.

Kyle Mikson

Now on that note, I guess the, you know, how do you guys kind of anticipate expenses, the cadence of expenses throughout this year? Because it was a little bit surprising to see the net loss and the kind of the lower than expected EBITDA in the quarter. As we think about cash flow positivity, and that's been this goal for, you know, 2026, 2027, for a while with that SEC, what's the updated thoughts on that, on metrics?

Derek Maetzold

As you know, we continue to focus growth on three windows, Kyle: near, medium, and long term. As we support that, we do expect some growth in operating expenses. I think as we get through Q1 here and we lap the more meaningful change in SCC revenue, we'll get to a more meaningful comparability period going forward. I think that we continue to grow into the P&L and leverage the cost structure and our intent there is to generate meaningful returns on those operating expenses, driving value going forward.

Operator

Your next question comes from the line of Puneet Souda with Leerink Partners. Your line is open. Please go ahead.

Puneet Souda

Yes. Hi, guys. Thanks for the questions here. First one, maybe on the guide itself, you beat by, you know, $4 million, raised about $5 million, largely banking the beat. Just wanted to understand how much of the beat was from SCC, and then I have a follow-up on the TissueCypher.

Derek Maetzold

Yeah. Most of that beat was driven by TissueCypher.

Puneet Souda

Okay. Got it. Then, you know, can you maybe provide a little bit more color on the TissueCypher ramp throughout the year? I think you called out you had two best quarter. That's, I think you mean March and April, two best month, March and April, maybe that was sequentially down. I didn't exactly catch that. Maybe if you can provide some more color there. How should we think about the ramp from 1Q to 2Q? I mean, it seems it could be larger than what you saw last year, you know, especially given another 18,000 up year-over-year. Maybe just talk to me in terms of the TissueCypher ramp. Thank you.

Frank Stokes

As we said, Puneet, we continue to think we'll add a similar number of tests for reports for 2026 as 2025. I think we're big enough or penetrated enough now that probably some seasonality is finally to the point where we feel it. As I referenced, the number of procedures tends to be lower in Q1. I think we'll see that growth come ratably through the year. I don't see, I'm not aware of things quarter-to-quarter that should shift that from more of a ratable ramp.

Operator

There are no further questions at this time. I will now turn the call back to Derek for closing remarks.

Derek Maetzold

This concludes our first quarter 2026 earnings call. Thank you again for joining us today and for your continued interest in Castle Biosciences.

Operator

This concludes today's call. Thank you for attending. You may now disconnect.

Investor releaseQuarter not tagged2026-05-02

KYMR Q1 Earnings Top Estimates, Revenues Gain on GILD Collaboration

Zacks

Kymera Therapeutics, Inc. KYMR posted a first-quarter 2026 loss of 71 cents per share, narrower than the Zacks Consensus Estimate of a loss of 89 cents. In the year-ago quarter, the company reported a loss of 82 cents per share. The company primarily earns revenues from collaborations with bigwigs like Gilead Sciences, Inc. GILD and Sanofi SNY. Quarterly revenues totaled $34.37 million, which rose 55.5% year over year and surpassed the Zacks Consensus Estimate of $11 million. All collaboration revenues recognized in the first quarter of 2026 were derived from the company’s partnership with GILD. Year to date, shares of KYMR have gained 5.3% against the industry’s 1.1% decline. Image Source: Zacks Investment Research Operating expenses increased as Kymera raised investment in its clinical pipeline and discovery engine. Research and development expenses amounted to $98.2 million, up 22.3% year over year, reflecting higher spending on the STAT6 program, platform and discovery efforts, along with continued growth in the R&D organization. General and administrative expenses increased 25.1% to $20.4 million. This can be attributed to higher legal and professional service fees and increased personnel and facility-related costs to support growth as a public company. Kymera exited the quarter with $1.55 billion in cash, cash equivalents and investments, supporting operating runway into 2029. The quarter’s top-line strength reflected collaboration activity, with recognized revenues tied to Kymera’s partnership with Gilead Sciences. Management noted that the upfront payment received upon signing the licensing and option agreement last year has now been fully recognized, setting the stage for milestone-driven revenue variability going forward. A key post-quarter development was Gilead’s decision to exercise its option to exclusively license KT-200, a first-in-class oral CDK2 molecular glue degrader. The exercise triggers a $45 million milestone payment expected to be received in the second quarter, and the agreement includes eligibility for roughly $700 million of additional milestone payments. KT-621 remains Kymera’s lead wholly owned program, an investigational once-daily oral STAT6 degrader for type II inflammatory diseases. The company is running two parallel phase IIb trials to accelerate decision-making and gather dose-ranging data across dermatology and respirato...

Investor releaseQuarter not tagged2026-05-01

AGIO Beats on Q1 Earnings & Sales, Stock Up 13% on New Drug Momentum

Zacks

Agios Pharmaceuticals AGIO reported a loss of $1.69 per share for the first quarter of 2026, narrower than the Zacks Consensus Estimate of a loss of $1.81. In the year-ago quarter, the company had incurred a loss of $1.55 per share. Total revenues for the first quarter of 2026 came in at $20.7 million, beating the Zacks Consensus Estimate of $13.8 million. Revenues surged 138% year over year, primarily driven by the U.S. commercial launch of Aqvesme and continued strong growth in Pyrukynd sales. The company’s lead drug, mitapivat, is marketed under two brand names in the United States — Pyrukynd and Aqvesme. While Pyrukynd is approved for the treatment of hemolytic anemia in adult patients with pyruvate kinase (PK) deficiency, Aqvesme is approved to treat anemia in adults with alpha- or beta-thalassemia. Aqvesme received approval in the United States in December 2025 and was subsequently launched in January following the implementation of its Risk Evaluation and Mitigation Strategy program. Agios reported a strong initial uptake, with 242 prescriptions written as of March 2026. Shares of AGIO rose 13% on Wednesday, likely due to the better-than-expected sales performance of its marketed products. Year to date, the stock has risen 3.1% against the industry’s 1.4% decline. Image Source: Zacks Investment Research Outside the United States, mitapivat continues to be marketed as Pyrukynd for both PK deficiency and thalassemia indications. In March 2026, Pyrukynd received approval for thalassemia in the United Arab Emirates. Meanwhile, a marketing authorization application seeking label expansion for Pyrukynd in the thalassemia indication is currently under review in the EU. The top line entirely comprises product revenues from Pyrukynd and Aqvesme. However, the company did not disclose separate sales figures for the two drugs. Agios generated $18.8 million of product revenues from the sales of both drugs in the United States. The reported figure was up 116% year over year, driven by strong early momentum of the U.S. commercial launch of Aqvesme in thalassemia. The company added $1.9 million from ex-U.S. territories, reflecting demand for Pyrukynd in the thalassemia indication across the Gulf Council Countries. Research & development expenses increased by approximately 11.6% year over year to $81.1 million in the first quarter due to higher costs related to pipeli...

Investor releaseQuarter not tagged2026-04-30

VKTX Q1 Earnings Miss on Higher Phase 3 Development Costs

Zacks

Viking Therapeutics VKTX posted a first-quarter 2026 loss of $1.37 per share, wider than the Zacks Consensus Estimate of a loss of 95 cents. The company had incurred a loss of 41 cents per share in the year-ago quarter. Currently, Viking Therapeutics does not have any approved products in its portfolio. It has yet to generate revenues. Year to date, the stock has lost 11% compared with the industry’s nearly 3% decline. Image Source: Zacks Investment Research Research and development expenses surged to $150.2 million in the first quarter of 2026 from $41.4 million a year ago. Management attributed the increase primarily to higher spending tied to clinical studies, manufacturing for drug candidates, consultants, salaries and benefits, and preclinical work. The stepped-up R&D cadence aligns with the company’s effort to run multiple large studies in parallel, including its ongoing phase III program for subcutaneous (SC) formulation of its investigational obesity drug, VK2735. Viking Therapeutics is also planning to move the oral version of the drug into late-stage development later this year. General and administrative expenses were $14.0 million, compared with $14.1 million in the year-ago quarter. Management cited lower costs related to legal and patent services and stock-based compensation, partially offset by higher spending on consulting, salaries and benefits, and scientific and disease education. Even with G&A largely stable, Viking continues to build operational capability around its obesity opportunity. During the quarter, the company announced the appointment of Neil Aubuchon as its first chief commercial officer, adding commercial leadership as VK2735 advances toward potential registration milestones. Viking ended the quarter with $603.0 million in cash, cash equivalents and short-term investments, down from $706.0 million at the end of 2025. The decline reflects the elevated cost of sustaining late-stage studies and supporting broader development activity across the pipeline. Management addressed the cadence of spending and cash usage. On the earnings call, the company indicated that next quarter’s expense and cash usage could be around the first-quarter level, potentially modestly lower. Expectations are for spending to taper somewhat in the second half of the year as the company continues to manage its balance sheet alongside clinical and operation...

As of 2026-05-18 • Updated weeklySource: Earnings sourceIngestion runbook