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Castle Biosciences, Inc.
Castle Biosciences Announces Fourth Quarter and Full-Year 2020 Results
Mar 8 2021
4 min read

Castle Biosciences Announces Fourth Quarter and Full-Year 2020 Results

Full-year 2020 revenues of $62.6 million, up 21% compared to 2019

Full-year 2020 dermatology test report volume up 8% compared to 2019

Full-year 2020 gross margin of 85%

Earlier today, the Company launched Integrated DecisionDx-Melanoma Test Result, Utilizing AI to Predict Individualized Risk

Conference call and webcast today at 4:30 p.m. ET

FRIENDSWOOD, Texas--(BUSINESS WIRE)-- Castle Biosciences, Inc. (Nasdaq: CSTL), a skin cancer diagnostics company providing personalized genomic information to improve cancer treatment decisions, today announced its financial results for the fourth quarter and twelve months ended Dec. 31, 2020.

“Our execution in 2020 allowed us to successfully navigate through this unique year and further our position as the leader in genomic testing for dermatologic cancers,” said Derek Maetzold, president and chief executive officer of Castle Biosciences. “We began the year with one skin cancer test and ended the year with a suite of three tests, more than tripling our estimated in-market U.S. total addressable market (TAM) to $2 billion.

“DecisionDx®-Melanoma, DecisionDx® DiffDx™- Melanoma and DecisionDx®-SCC, our tests for cutaneous melanoma, suspicious pigmented lesions and high-risk cutaneous squamous cell carcinoma, respectively, are each designed to provide actionable information for dermatology clinicians, which helps to guide cancer management decisions and improve patient outcomes.

“We are now entering the next chapter of our growth story. Earlier today, we announced clinical availability of an artificial intelligence-based integrated DecisionDx-Melanoma test result – integrating meaningful clinical and pathologic features with tumor biology identified by our DecisionDx-Melanoma test – designed to provide a more precise prediction of risk. Further, we are developing several pipeline tests that are focused on answering clinical questions with high unmet need along the patient care continuum. We estimate these pipeline tests could add an additional $3.6 billion to our U.S. TAM, bringing our aggregate U.S. TAM to slightly more than $5.5 billion.”

Twelve Months Ended December 31, 2020, Financial Highlights

  • Revenues were $62.6 million, a 21% increase compared to $51.9 million during the same period in 2019. Included in revenue for the period were positive revenue adjustments related to tests delivered in prior periods. These positive prior period revenue adjustments for the twelve months ended Dec. 31, 2020, were $0.2 million, compared to $2.5 million for the same period in 2019.
  • Total gene expression profile test reports delivered in 2020 were 18,185, compared to 17,055 in 2019:
    • DecisionDx-Melanoma test reports delivered in 2020 were 16,232, compared to 15,529 in 2019. Third-party data for 2020 suggests that diagnoses of melanoma were down more than 20% over the prior year.
    • DecisionDx-SCC test reports delivered in 2020 (Aug. 31, 2020 – Dec. 31, 2020) were 485.
    • DecisionDx DiffDx-Melanoma test reports delivered in 2020 (Nov. 2, 2020 - Dec. 31, 2020) were 73.
    • DecisionDx-UM test reports delivered in 2020 were 1,395, compared to 1,526 in 2019.
  • Gross margin for the twelve months ended Dec. 31, 2020, was 85%.
  • Operating cash flow was $9.9 million, compared to $7.0 million for the same period in 2019.
  • Adjusted operating cash flow, excluding the effects of certain relief payments described below, was $1.5 million, compared to $7.0 million for the same period in 2019.

Cash and Cash Equivalents

As of Dec. 31, 2020, the Company’s cash and cash equivalents totaled $410 million.

Fourth Quarter Ended December 31, 2020, Financial Highlights

  • Revenues were $17.3 million in the fourth quarter of 2020, compared to $17.6 million in the fourth quarter of 2019. Included in revenue for the quarters were positive revenue adjustments related to tests delivered in prior periods. These positive prior period revenue adjustments for the three months ended Dec. 31, 2020, were $3.5 million, compared to $4.3 million for the same period in 2019.
  • Delivered 5,157 total gene expression profile test reports in the fourth quarter of 2020, compared to 4,914 in the same period in 2019:
    • DecisionDx-Melanoma test reports delivered in the quarter were 4,246, compared to 4,480 in the same period in 2019.
    • DecisionDx-SCC test reports delivered in the quarter were 428.
    • DecisionDx DiffDx-Melanoma test reports delivered from Nov. 2 through Dec. 31, 2020, were 73.
    • DecisionDx®-UM test reports delivered in the quarter were 410, compared to 434 in the same period in 2019.
  • Gross margin in the fourth quarter of 2020 was 85%.
  • Operating cash flow was $(0.4) million in the fourth quarter of 2020, compared to $4.5 million in the fourth quarter of 2019.
  • Adjusted operating cash flow, excluding the effects of certain relief payments described below, was $1.5 million in the fourth quarter of 2020, compared to $4.5 million in the fourth quarter of 2019.

Recent Clinical Evidence Highlights

  • On March 8, 2021, the Company announced clinical availability of an artificial intelligence-based integrated DecisionDx-Melanoma test result. The Company validated the integration of clinicopathologic features with the tumor biology insights provided by the DecisionDx-Melanoma test. The integrated test result (ITR) is designed to provide a more precise risk prediction to further improve the clinical actionability by clinicians and their patients in helping to guide cancer management decisions. For more information, see the Company’s news release from earlier today.
  • In January 2021, the Company presented data on DecisionDx-Melanoma and DecisionDx DiffDx-Melanoma at the 18th Annual Winter Clinical Dermatology Conference:
    • The virtual poster for DecisionDx-Melanoma was entitled, “Identifying predictors of sentinel lymph node metastasis in cutaneous melanoma patients using molecular and clinicopathologic high-risk features.” For 3,093 patients with T1-T4 cutaneous melanoma, authors used decision tree analysis to determine which molecular and clinicopathologic features best stratify sentinel lymph node (SLN) positivity risk and demonstrated that DecisionDx-Melanoma was the most important feature in distinguishing between high and low SLN-positivity rates (p