Castle Biosciences, Inc. (CSTL) SEC Filings & Earnings Calls

Medicare Coverage Loss for DecisionDx-SCC

“On April 24, 2025, the Novitas LCD, Genetic Testing for Oncology: Specific Tests, that includes DecisionDx-SCC as noncovered, became effective.” · word for word

History of Net Losses and Accumulated Deficit

“For the six months ended June 30, 2026, we had net loss of $16.6 million, and as of June 30, 2026, we had an accumulated deficit of $240.9 million.” · word for word

Geopolitical and Macroeconomic Uncertainty

“Macroeconomic conditions, including uncertainties associated with the ongoing conflicts in the Middle East... continue to have direct and indirect impacts on our business” · word for word

Medicare coverage change for DecisionDx-SCC may pressure revenue.

“Affecting second quarter 2026 revenue was the change in DecisionDx-SCC Medicare coverage effective April 24, 2025.” · word for word

Discontinuation of IDgenetix may reduce future revenue streams.

“discontinuation of IDgenetix in May 2025.” · word for word

Revenue decline in Q1 2026 vs Q1 2025 due to Medicare coverage change for DecisionDx-SCC and discontinuation of IDgenetix

“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” · word for word

Negative operating cash flow and adjusted EBITDA in Q1 2026, partly due to one-time bonus and benefit payments

“Net cash used in operations was $22.1 million... 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” · word for word

Medicare Coverage Loss for DecisionDx-SCC

“On April 24, 2025, the Novitas LCD, Genetic Testing for Oncology: Specific Tests, that includes DecisionDx-SCC as noncovered, became effective.” · word for word

Revenue Concentration on Two Tests

“Our revenue in 2025 was primarily derived from the sale of our DecisionDx-Melanoma, TissueCypher, and DecisionDx-SCC tests. While we also derive revenue from our other tests, we expect that the majority of our revenue for the next several years will be derived from sales of our DecisionDx-Melanoma and TissueCypher tests.” · word for word

History of Net Losses

“Since our inception, we have had a history of net losses. For the year ended December 31, 2025, we had net loss of $24.2 million, and as of December 31, 2025, we had an accumulated deficit of $224.3 million.” · word for word

Macroeconomic and Geopolitical Uncertainty

“Macroeconomic conditions, including uncertainties associated with the ongoing conflicts in the Middle East, including the conflict between the U.S. and Iran, the ongoing conflict between Ukraine and Russia and related sanctions, economic slowdowns, the recent shutdown of the federal government including regulatory agencies, public health crises, labor shorta” · word for word

Reimbursement risk for DecisionDx-SCC test

“In setting this performance range, the Compensation Committee considered the loss of Medicare coverage for our DecisionDx-SCC test, effective April 24, 2025, which had an adverse impact on our 2025 revenue.” · word for word

Concentration on core tests

“Total test report volume for our core revenue drivers, DecisionDx®-Melanoma and TissueCypher®, increased 37% over 2024” · word for word

Payor concentration risk

“Our revenue for our test reports provided for patients covered by Medicare as a percentage of total revenue, was 44% and 47% for the years ended December 31, 2025 and 2024, respectively. Additionally, there was a commercial payor from which 16% of our revenue from patients were derived for the year ended December 31, 2025.” · word for word

Product concentration risk

“Revenues from our DecisionDx-SCC test represented a significant portion of our 2025 revenues but are not expected to be so in our 2026 operating results.” · word for word

History of losses

“For the year ended December 31, 2025, we had net loss of $24.2 million, and as of December 31, 2025, we had an accumulated deficit of $224.3 million.” · word for word

Medicare coverage change for DecisionDx-SCC and discontinuation of IDgenetix negatively impacted revenue growth.

“Affecting year ended Dec. 31, 2025, 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.” · word for word

Net loss and lower Adjusted EBITDA due to increased SG&A and one-time amortization charge.

“Net loss for 2025...was $24.2 million, compared to net income of $18.2 million in 2024. Adjusted EBITDA for 2025 was $44.0 million, compared to $75.0 million in 2024.”

Medicare coverage change for DecisionDx-SCC affecting volume; commercial efforts refocused.

“Affecting fourth quarter test report volume was the change in Medicare coverage effective April 24, 2025, and re-focus of our commercial efforts.” · word for word

Preliminary results subject to audit; actual results may differ.

“Castle Biosciences has not completed the preparation of its financial statements for the fourth quarter or year ended Dec. 31, 2025.” · word for word

Medicare Coverage Loss for Key Product

“On April 24, 2025, the Novitas LCD, Genetic Testing for Oncology: Specific Tests, that includes DecisionDx-SCC as noncovered, became effective.” · word for word

Revenue Concentration and Decline

“Revenues from our DecisionDx-SCC test represented a significant portion of our 2024 revenues but are not expected to be so in our 2025 operating results.” · word for word

Swing to Net Loss and Accumulated Deficit

“For the nine months ended September 30, 2025, we had net loss of $21.8 million, and as of September 30, 2025, we had an accumulated deficit of $222.0 million.” · word for word

Regulatory Uncertainty for LDTs

“Despite FDA’s rescission of the LDT final rule, if the FDA implements new policy that affects LDTs or their components, and our products become subject to the FDA’s requirements for premarket review of medical devices, we may be required to cease commercial sales of our products.” · word for word

Novitas LCD coverage determination for DecisionDx-SCC as noncovered effective April 2025, impacting revenue and test volume.

“Affecting third quarter 2025 revenue was the Novitas local coverage determination (LCD), Genetic Testing in Oncology: Specific Tests, that included DecisionDx-SCC as noncovered, which became effective April 24, 2025” · word for word

Discontinuation of IDgenetix test in May 2025, reducing product portfolio diversity.

“as well as the discontinuation of IDgenetix in May 2025.” · word for word