On August 2, 2023 Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, reported its financial results for the second quarter and six months ended June 30, 2023 (Press release, Castle Biosciences, AUG 2, 2023, View Source [SID1234633642]).
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"Castle delivered an outstanding second quarter, with strength across our entire test portfolio," said Derek Maetzold, president and chief executive officer of Castle Biosciences. "Building on our first quarter momentum and driven by consistent execution across the entire Castle team, we delivered strong test report volume and revenue growth. Based on strong first half 2023 execution and confidence in our business, we are raising our 2023 revenue guidance to at least $180 million.
"In addition, we expanded our body of evidence, further demonstrating the clinical value of our innovative tests and supporting adoption by clinicians and payers. Specifically, two patient outcome studies on our DecisionDx-Melanoma test were published in the second quarter. The first study was from our collaboration with the National Cancer Institute’s SEER Program Registries. Data from this study showed that testing with DecisionDx-Melanoma was associated with lower melanoma-specific and overall mortality relative to untested patients. A similar study was published by Dhillon, et al. This independent, multi-center study found that sentinel lymph node negative patients whose follow-up treatment pathway was directed by the DecisionDx-Melanoma test for use of routine imaging in patients with high-risk DecisionDx-Melanoma results led to earlier detection of recurrences, when the tumor burden was lower. At study end, 76% of patients in the tested group who had a melanoma recurrence were alive compared to 50% in the untested group.
"Additionally, during open comment periods, we had the opportunity to present data to a number of Medicare contractors related to one of the treatments that our DecisionDx-SCC test has been shown to inform, adjuvant radiation therapy (ART). These data from a matched control analysis compare patients with high-risk squamous cell carcinoma (SCC) with one or more risk factors who received ART and those who did not. When evaluating this cohort, we observed that the DecisionDx-SCC Class 2B result could identify a group of patients with a significant reduction in metastasis rate after having received ART and that the DecisionDx-SCC Class 1 patients did not receive a benefit from ART.
"Our continued success is a testament to the ongoing dedication of our team to our patient-centric mission. With a track record of delivering on our short- and long-term strategies, combined with a healthy balance sheet and multi-year plan to deliver revenue growth and positive net operating cash flow by year-ending 2025, we are managing the business with a goal of driving near- and long-term shareholder value."
Second Quarter Ended June 30, 2023, Financial and Operational Highlights
•Revenues were $50.1 million, a 44% increase compared to $34.8 million during the same period in 2022. Included in revenue for the period were revenue adjustments related to tests delivered in prior periods. These prior period revenue adjustments for the quarter ended June 30, 2023, were $0.1 million of net negative revenue adjustments, compared to $0.6 million of net positive revenue adjustments for the same period in 2022.
•Adjusted revenues, which exclude the effects of revenue adjustments related to tests delivered in prior periods, were $50.2 million, a 47% increase compared to $34.3 million for the same period in 2022.
•Delivered 16,820 total test reports in the second quarter of 2023, an increase of 52% compared to 11,034 in the same period of 2022:
◦DecisionDx-Melanoma test reports delivered in the quarter were 8,597, compared to 7,125 in the second quarter of 2022, an increase of 21%.
◦DecisionDx-SCC test reports delivered in the quarter were 2,681, compared to 1,344 in the second quarter of 2022, an increase of 99%.
◦MyPath Melanoma test reports delivered in the quarter were 953, compared to 955 MyPath Melanoma and DiffDx-Melanoma aggregate test reports in the second quarter of 2022.
◦DecisionDx-UM test reports delivered in the quarter were 461, compared to 431 in the second quarter of 2022, an increase of 7%.
◦TissueCypher Barrett’s Esophagus test reports delivered in the quarter were 1,447, compared to 352 in the second quarter of 2022, an increase of 311%.
◦IDgenetix test reports delivered in the quarter were 2,681, compared to 827 in the second quarter of 2022, an increase of 224%.
•Gross margin for the quarter ended June 30, 2023, was 73%, and adjusted gross margin was 78%.
•Net cash used in operations was $3.8 million, compared to $9.0 million for the same period in 2022.
•Net loss for the second quarter, which includes non-cash stock-based compensation expense of $12.8 million, was $(18.8) million, compared to $(1.6) million for the same period in 2022.
•Adjusted EBITDA for the second quarter was $(5.3) million, compared to $(11.2) million for the same period in 2022.
Six Months Ended June 30, 2023, Selected Results
•Revenues were $92.2 million, a 49% increase compared to $61.7 million during the same period in 2022. Included in revenue for the period were revenue adjustments related to tests delivered in prior periods. These prior period revenue adjustments for the six months ended June 30, 2023, were $1.7 million of net negative revenue adjustments, compared to $0.3 million of net negative revenue adjustments for the same period in 2022.
•Adjusted revenues, which exclude the effects of revenue adjustments related to tests delivered in prior periods, were $93.9 million, a 51% increase compared to $62.0 million for the same period in 2022.
•Delivered 31,736 total test reports in the six months ended June 30, 2023, an increase of 61% compared to 19,661 in the same period of 2022:
◦DecisionDx-Melanoma test reports delivered in the six months ended June 30, 2023, were 16,180, compared to 13,148 for the same period in 2022, an increase of 23%.
◦DecisionDx-SCC test reports delivered in the six months ended June 30, 2023, were 5,092, compared to 2,486 for the same period in 2022, an increase of 105%.
◦MyPath Melanoma and DiffDx-Melanoma test reports delivered in the six months ended June 30, 2023, were 1,933, compared to 1,905 MyPath Melanoma and DiffDx-Melanoma aggregate test reports for the same period in 2022, an increase of 1%.
◦DecisionDx-UM test reports delivered in the six months ended June 30, 2023, were 870, compared to 887 for the same period in 2022, a decrease of 2%.
◦TissueCypher Barrett’s Esophagus test reports delivered in the six months ended June 30, 2023, were 2,830, compared to 408 for the same period in 2022, following our initial offering of the test beginning in December 2021.
◦IDgenetix test reports delivered in the six months ended June 30, 2023, were 4,831, compared to 827 for the same period in 2022, following our initial offering of the test beginning in April 2022.
•Gross margin for the six months ended June 30, 2023, was 72%, and adjusted gross margin was 77%.
•Net cash used in operations was $29.2 million, compared to $30.4 million for the same period in 2022.
•Net loss for the six months ended June 30, 2023, which includes non-cash stock-based compensation expense of $26.4 million, was $(48.0) million, compared to $(26.3) million for the same period in 2022.
•Adjusted EBITDA for the six months ended June 30, 2023, was $(20.4) million, compared to $(22.6) million for the same period in 2022.
Cash, Cash Equivalents and Marketable Investment Securities
As of June 30, 2023, the Company’s cash, cash equivalents and marketable investment securities totaled $225.5 million.
2023 Outlook
Castle Biosciences is increasing its guidance for anticipated total revenue in 2023. The Company now anticipates generating at least $180 million in total revenue in 2023 compared to the previously provided guidance of $170-180 million.
Second Quarter and Recent Accomplishments and Highlights
Dermatology
•DecisionDx-Melanoma: In June, the Company announced the initial publication of its collaboration with the National Cancer Institute’s SEER Program Registries. This large study of real-world, unselected patients confirmed prior prospective and retrospective studies showing DecisionDx-Melanoma provided clinically meaningful and significant, independent risk stratification of patients with cutaneous melanoma (CM), beyond American Joint Committee on Cancer Eighth Edition (AJCC8) stage. Additionally, the study showed that testing with DecisionDx-Melanoma was associated with lower melanoma-specific and overall mortality relative to untested patients. The publication can be found here.
•DecisionDx-Melanoma: In May, the Company announced an independent, multi-center study providing a direct chain of evidence that use of DecisionDx-Melanoma test results to guide radiological surveillance could lead to improved patient outcomes. Specifically, this study directly compared the impact of management changes in sentinel lymph node negative patients whose follow-up pathway was directed by the DecisionDx-Melanoma test to patients in the same institution who were not tested and, therefore, did not have their follow-up pathway changed from the institution’s traditional follow-up pathway. The results showed that metastasis was detected earlier, when the tumor burden was smaller, and at study end, 76% of patients in the tested group who had a metastasis were alive compared to 50% in the untested group. The study, authored by Dhillon et al., can be found here.
•DecisionDx-SCC: In June, the Company announced new data demonstrating the ability of the DecisionDx-SCC test to identify cutaneous squamous cell carcinoma (cSCC) tumors at a biologically high risk of metastasis in a subset of patients considered to be at a low risk of metastasis by traditional staging. In the study, the DecisionDx-SCC test was able to significantly stratify three-year metastasis free survival rates within the AJCC8 and Brigham and Women’s Hospital T1 populations of the cSCC cohort. See the Company’s news release from June 12, 2023, for more information.
•DecisionDx-SCC: In June, the Company announced the publication of a paper highlighting a clinician-derived, real-world algorithm that provides a framework to incorporate DecisionDx-SCC test results into clinical practice within National Comprehensive Cancer Network (NCCN) guideline recommendations. This framework for stratifying patients with advanced cSCC includes a treatment algorithm that demonstrates how use of DecisionDx-SCC test results can assist clinicians in identifying personalized, risk-aligned treatment pathway improvements for patients with high-risk cSCC, based on the patient’s tumor biology, which may help improve their disease outcome. The publication can be found here.
Gastroenterology
•In May, the Company announced that its three posters at the recent Digestive Disease Week Annual Meeting were honored as "Posters of Distinction" by the American Gastroenterological Association Institute Council, ranking among the top 10% of the more than 3,100 abstracts showcased during the meeting. See the Company’s news release from May 26, 2023, for more information.
•In May, the Company announced that it had been selected as the winner of the "Best Use of Artificial Intelligence in Healthcare" award in the seventh annual MedTech Breakthrough Awards program for its innovative TissueCypher Barrett’s Esophagus (BE) test. The TissueCypher test provides clinicians with important information about a patient’s individual risk of progression to esophageal cancer based on advanced analysis of biopsied tissue to guide more informed and risk-aligned management of BE patients. See the Company’s news release from May 15, 2023, for more information.
Mental Health
•In June, ECRI, an independent, nonprofit organization improving the safety, quality and cost-effectiveness of care across all healthcare settings, concluded its genetic test assessment of Castle’s
IDgenetix test with a four out of five, or "Somewhat Favorable," rating. Commercial payers utilize ECRI evaluations to assist in making coverage decisions.
•In May, the Company announced real-world study data demonstrating that use of IDgenetix to guide medication management can significantly improve medication response and remission rates in patients diagnosed with moderate to severe depression, compared to current standard-of-care treatment. The study abstract can be found here.
Corporate
•In July, the Company announced that it had earned a second consecutive Arizona Top Workplace award from AZ Central, the digital home of The Arizona Republic newspaper. See the Company’s news release from July 17, 2023, for more information.
•In May, the Company announced that it opened a new state-of-the-art laboratory facility in Pittsburgh. The new 20,000-square-foot facility doubles the size of its previous Pittsburgh laboratory and is expected to have the capacity and ability to process each of its proprietary tests. Additionally, the Company anticipates doubling its workforce in Pittsburgh, creating approximately 35 new jobs by the end of 2023. See the Company’s news release from May 22, 2023, for more information.
Conference Call and Webcast Details
Castle Biosciences will hold a conference call on Wednesday, August 2, 2023, at 4:30 p.m. Eastern time to discuss its second quarter 2023 results and provide a corporate update.
A live webcast of the conference call can be accessed here: View Source or via the webcast link on the Investor Relations page of the Company’s website, View Source 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 23, 2023.
To access the live conference call via phone, please dial 833 470 1428 from the United States, or +1 404 975 4839 internationally, at least 10 minutes prior to the start of the call, using the conference ID 967509.
There will be a brief Question & Answer session following management commentary.