“How Long Have I Got?” in Stage IV NSCLC Patients With at Least 3 Months Up to 10 Years Survival, Accuracy of Long-, Intermediate-, and Short-Term Survival Prediction Is Not Good Enough to Answer This Question
How Does Small Cell Lung Cancer Staging Work?
Doctors typically divide small cell lung cancer (SCLC) into limited or extensive stages, depending on whether the cancer is in one lung, both lungs, or has spread to distant areas.
Staging for small cell lung cancer (SCLC) can help identify how advanced the cancer is and its best treatment.
In addition to the "limited" or "extensive" stages, doctors also classify SCLC into stages relating to the size and location of the tumor and whether the cancer has spread to the lymph nodes or distant organs. This article looks at the systems doctors use to stage SCLC.
Doctors use results from diagnostic tests to determine the stage of SCLC. These may include:
The results of these tests can show doctors the size and location of a tumor, any lymph node involvement, and whether the cancer has spread to distant areas. This information allows doctors to stage SCLC.
Extensive-stage SCLC means the cancer has spread throughout one or both lungs or to other parts of the body.
There is no cure for extensive-stage SCLC, but treatments, such as chemotherapy and immunotherapy, may help control the cancer.
Doctors use the American Joint Committee on Cancer (AJCC) TNM staging system to classify cancer based on the following factors:
Doctors then assign additional numbers or letters to describe each factor.
Doctors use the American Joint Committee on Cancer (AJCC) TNM system to stage lung cancer, although it is typically used more for non-small cell lung cancer than SCLC, which doctors more often categorize as extensive or limited-stage.
The TNM stages range from 0 to 4 and also have substages. Higher stages are more advanced.
Occult, or hidden, cancer is before stage 0. At the occult stage, doctors cannot identify the location of the lung cancer but do not think it has spread to lymph nodes or distant areas. Cancer cells may appear in lung fluid samples but do not show on other tests.
Stage 0 Stage 1 Stage 2 Stage 3 Stage 4 How quickly does small cell lung cancer progress?SCLC grows and spreads quickly. The doubling time of cancer describes how quickly a tumor doubles in size. The doubling time of SCLC may be around 25 to 30 days.
Is small cell lung cancer considered terminal?SCLC is difficult to cure and has a low survival rate. Limited-stage SCLC has a better outlook than extensive-stage SCLC, and combined treatments may improve long-term survival. Long-term, disease-free survival is rare with extensive-stage SCLC.
What is the life expectancy of someone with small cell lung cancer?Without treatment, the life expectancy with SCLC is around 2 to 4 months after diagnosis. With treatment, people with limited-stage SCLC may have a life expectancy of around 16 to 24 months after diagnosis. For extensive-stage SCLC, the life expectancy may be around 6 to 12 months with treatment.
Read more about the life expectancy of someone with SCLC.
Doctors use the results of diagnostic tests to stage small cell lung cancer (SCLC). Staging identifies the extent of the tumor, lymph node involvement, and whether the cancer has spread to distant areas of the body.
Staging cancer helps doctors identify how advanced the cancer is and decide on the best course of treatment.
Castle Biosciences Reports Second Quarter 2024 Results
Q2 2024 revenue increased 74% over Q2 2023 to $87 million
Q2 2024 total test reports increased 49% over Q2 2023
Raising full-year 2024 revenue guidance to $275-300 million from $255-265 million
Conference call and webcast today at 4:30 p.M. ET
FRIENDSWOOD, Texas, August 05, 2024--(BUSINESS WIRE)--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 and six months ended June 30, 2024.
"We achieved another quarter of exceptional performance, thanks to the hard work of our talented team and strength of our innovative test portfolio," said Derek Maetzold, president and chief executive officer of Castle Biosciences. "We were especially pleased with the substantial top-line growth as well as growth in test report volumes across our therapeutic areas."
"Regarding our DecisionDx®-SCC test, we were also pleased to see the publication of our first study evaluating the use of DecisionDx-SCC to guide adjuvant radiation therapy (ART) recommendations in patients diagnosed with high-risk cutaneous squamous cell carcinoma (SCC). This study, which is the largest study to evaluate the effectiveness of ART in SCC, found that the DecisionDx-SCC test can identify patients who are considering ART under traditional clinicopathologic risk features and have a low likelihood of metastasis and a low likelihood of a receiving a clinical benefit from ART – thus enabling deferral of radiation therapy and avoidance of complications and associated impacts on the patient's quality of life. This study was published in the American Society for Radiation Oncology's flagship journal, International Journal of Radiation Oncology, Biology, Physics (also known as the Red Journal).
"Regarding our TissueCypher® Barrett's Esophagus test, the American Gastroenterological Association (AGA) recently recognized in its Clinical Practice Guideline that there is a high-risk subset of non-dysplastic Barrett's esophagus patients who may benefit from early intervention with endoscopic eradication therapy (EET) and importantly, acknowledged that tissue-based biomarker testing, including the tissue systems pathology test (i.E., TissueCypher, also known as TSP-9) can help identify these patients.
"We believe we are well-positioned for near- and long-term success, supported by the potential for continued growth across our portfolio, as well as by our robust balance sheet and proven track record of strong execution. I am proud of what we have accomplished, and we will continue to work to operate with speed and agility to deliver value to patients, clinicians and stockholders alike."
Second Quarter Ended June 30, 2024, Financial and Operational Highlights
Revenues were $87.0 million, a 74% increase compared to $50.1 million in the second quarter of 2023. Included in revenue for the period were revenue adjustments related to tests delivered in prior periods. These prior period revenue adjustments for the quarter were $0.4 million of net positive revenue adjustments, compared to $0.1 million of net negative revenue adjustments for the same period in 2023.
Adjusted Revenues, which exclude the effects of revenue adjustments related to tests delivered in prior periods, were $86.6 million, a 72% increase compared to $50.2 million for the same period in 2023.
Delivered 25,102 total test reports in the second quarter of 2024, an increase of 49% compared to 16,820 in the same period of 2023:
DecisionDx®-Melanoma test reports delivered in the quarter were 9,585, compared to 8,597 in the second quarter of 2023, an increase of 11%.
DecisionDx-SCC test reports delivered in the quarter were 4,277, compared to 2,681 in the second quarter of 2023, an increase of 60%.
MyPath® Melanoma test reports delivered in the quarter were 1,099, compared to 953 in the second quarter of 2023, an increase of 15%.
TissueCypher Barrett's Esophagus test reports delivered in the quarter were 4,782, compared to 1,447 in the second quarter of 2023, an increase of 230%.
IDgenetix® test reports delivered in the quarter were 4,903, compared to 2,681 in the second quarter of 2023, an increase of 83%.
DecisionDx®-UM test reports delivered in the quarter were 456, compared to 461 in the second quarter of 2023, a decrease of 1%.
Gross margin was 81%, and Adjusted Gross Margin was 83%, compared to 74% and 78%, respectively, for the same periods in 2023.
Net cash provided by operations was $24.0 million, compared to $3.8 million net cash used in operations for the same period in 2023.
Net income, which includes non-cash stock-based compensation expense of $13.2 million, was $8.9 million, compared to a net loss of $(18.8) million for the same period in 2023.
Adjusted EBITDA was $21.5 million, compared to $(5.3) million for the same period in 2023.
Six Months Ended June 30, 2024, Financial and Operational Highlights
Revenues were $160.0 million, a 74% increase compared to $92.2 million during the same period in 2023. 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, 2024, were $1.0 million of net positive revenue adjustments, compared to $1.7 million of net negative revenue adjustments for the same period in 2023.
Adjusted Revenues, which exclude the effects of revenue adjustments related to tests delivered in prior periods, were $159.0 million, a 69% increase compared to $93.9 million for the same period in 2023.
Delivered 45,990 total test reports in the six months ended June 30, 2024, an increase of 45% compared to 31,736 in the same period of 2023:
DecisionDx-Melanoma test reports delivered in the six months ended June 30, 2024, were 17,969, compared to 16,180 for the same period in 2023, an increase of 11%.
DecisionDx-SCC test reports delivered in the six months ended June 30, 2024, were 7,854, compared to 5,092 for the same period in 2023, an increase of 54%.
MyPath Melanoma test reports delivered in the six months ended June 30, 2024, were 2,097, compared to 1,933 for the same period in 2023, an increase of 8%.
TissueCypher Barrett's Esophagus test reports delivered in the six months ended June 30, 2024, were 8,211, compared to 2,830 for the same period in 2023, an increase of 190%.
IDgenetix test reports delivered in the six months ended June 30, 2024, were 8,981, compared to 4,831 for the same period in 2023, an increase of 86%.
DecisionDx-UM test reports delivered in the six months ended June 30, 2024, were 878, compared to 870 for the same period in 2023, an increase of 1%.
Gross margin for the six months ended June 30, 2024, was 79%, and Adjusted Gross Margin was 82%.
Net cash provided by operations was $17.2 million, compared to $29.2 million net cash used in operations for the same period in 2023.
Net income for the six months ended June 30, 2024, which includes non-cash stock-based compensation expense of $25.9 million, was $6.4 million, compared to a net loss of $(48.0) million for the same period in 2023.
Adjusted EBITDA for the six months ended June 30, 2024, was $32.1 million, compared to $(20.4) million for the same period in 2023.
Cash, Cash Equivalents and Marketable Investment Securities
As of June 30, 2024, the Company's cash, cash equivalents and marketable investment securities totaled $259.7 million.
2024 Outlook
Based upon revenue generated through June 30, 2024, the Company is increasing its guidance for anticipated total revenue in 2024 to between $275–300 million, compared to the previously provided guidance of between $255–265 million.
Second Quarter and Recent Accomplishments and Highlights
Dermatology
DecisionDx-SCC: The Company announced the publication of a study in the International Journal of Radiation Oncology, Biology, Physics (Red Journal) demonstrating the ability of the DecisionDx-SCC test to identify high-risk SCC patients who are likely to benefit from ART to reduce metastatic disease progression, as well as high-risk patients who are unlikely to benefit from ART and who, therefore, may consider deferring treatment. This study is the single largest study ever conducted to evaluate the effectiveness of ART in patients diagnosed with SCC and demonstrates the impact of the test in guiding decision-making for recommending ART. See the Company's news release from May 29, 2024, for more information.
DecisionDx-SCC: The Company also shared new data that supported the utility of DecisionDx-SCC in patients with high-risk SCC tumors located on the head and neck at the 56th American College of Mohs Surgery (ACMS) Annual Meeting in Phoenix. Data presented demonstrated that testing with DecisionDx-SCC significantly increased the prediction accuracy of metastatic events, when used alone and when combined with National Comprehensive Cancer Network (NCCN) guidelines, Brigham and Women's Hospital (BWH) staging or American Joint Committee on Cancer Staging Manual, 8th Edition (AJCC8) staging, to better guide risk-aligned patient care decisions regarding metastatic surveillance or the use of adjuvant treatments like radiation. See the Company's news release from May 3, 2024, for more information.
DecisionDx-Melanoma: The Company presented new data relating to its DecisionDx-Melanoma test at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, demonstrating the test's ability to identify patients with localized cutaneous melanoma at the highest risk of metastasis to the central nervous system (CNS). Specifically, the study showed that DecisionDx-Melanoma can identify patients with earlier-stage melanoma who have a higher risk of CNS metastasis within the first three years post-diagnosis. These higher-risk patients may benefit from more frequent imaging surveillance to identify CNS metastases earlier to improve patient survival. See the Company's news release from May 30, 2024, for more information.
Gastroenterology
The Company announced that the AGA published new clinical practice guidelines for EET to treat Barrett's esophagus (BE) and prevent its progression to esophageal adenocarcinoma. These guidelines recognized that there is a high-risk subset of patients with non-dysplastic BE (NDBE) who may benefit from early intervention with EET and acknowledged the role that tissue-based biomarkers, including TissueCypher, can play in identifying these patients. See the Company's news release from June 24, 2024, for more information.
The Company also shared three abstracts supporting the ability of its TissueCypher test to predict risk of progression to esophageal cancer in patients with BE at the Digestive Disease Week (DDW) 2024 Annual Meeting in Washington, D.C. The data that was shared further expanded the substantial clinical evidence supporting TissueCypher and its ability to improve the care that BE patients receive. See the Company's news release from May 14, 2024, for more information.
Mental Health
The Company was selected as the winner of the "Best Overall Mental Health Solution" award in the eighth annual MedTech Breakthrough Awards program for its IDgenetix pharmacogenomic (PGx) test. The MedTech Breakthrough Awards honor excellence and recognize innovation, hard work and success in a range of health and medical technology categories, attracting thousands of nominations from over 18 countries across the world. See the Company's news release from May 10, 2024, for more information.
Uveal Melanoma
The Company announced results from the largest prospective study to date of patients with uveal melanoma, titled "15-Gene Expression Profile and PRAME as Integrated Prognostic Test for Uveal Melanoma: First Report of Collaborative Ocular Oncology Group Study No. 2 (COOG2.1)," confirming the prognostic accuracy of the DecisionDx-UM test and providing the first prospective validation of Preferentially Expressed Antigen in Melanoma (PRAME) status as a risk refinement tool when considered in the context of a Class 1 or Class 2 DecisionDx-UM result. The study data demonstrated that together, these two tests can guide more precise and risk-aligned decision-making for patients with UM, including referrals, intensity of imaging surveillance and eligibility for ongoing clinical trials. See the Company's news release from May 8, 2024, and the published paper in the Journal of Clinical Oncology for more information.
Corporate
The Company announced that its founder, president and chief executive officer, Derek Maetzold, was named by Ernst & Young LLP (EY) as an Entrepreneur Of The Year® 2024 Gulf South Award winner. Now in its 38th year, Entrepreneur Of The Year is the preeminent competitive awards program that celebrates entrepreneurs and leaders of high-growth companies who disrupt markets, revolutionize sectors and have a transformational impact on lives. See the Company's news release from June 14, 2024, for more information.
Conference Call and Webcast Details
Castle Biosciences will hold a conference call on Monday, August 5, 2024, at 4:30 p.M. Eastern time to discuss its second quarter 2024 results and provide a corporate update.
A live webcast of the conference call can be accessed here: https://events.Q4inc.Com/attendee/952012940 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 August 26, 2024.
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 802518.
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 and Adjusted EBITDA, 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 income (loss): interest income, interest expense, income tax expense (benefit), depreciation and amortization expense, stock-based compensation expense, change in fair value of contingent consideration and acquisition related transaction costs.
We use Adjusted Revenues, Adjusted Gross Margin and Adjusted EBITDA 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. 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 or net income (loss) 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. The Company aims to transform disease management by keeping people first: patients, clinicians, employees and investors.
Castle's current portfolio consists of tests for skin cancers, Barrett's esophagus, mental health conditions and uveal melanoma. Additionally, the Company has active research and development programs for tests in other diseases with high clinical need, including its test in development to help guide systemic therapy selection for patients with moderate-to-severe, atopic dermatitis, psoriasis and related conditions. To learn more, please visit www.CastleBiosciences.Com and connect with us on LinkedIn, Facebook, X and Instagram.
DecisionDx-Melanoma, DecisionDx-CMSeq, DecisionDx-SCC, MyPath Melanoma, DiffDx-Melanoma, TissueCypher, IDgenetix, 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: (i) our 2024 total revenue guidance of $275-300 million; (ii) the potential of our tests to improve patient outcomes, including increased survival; (iii) our continued commercial momentum in 2024; (iv) our ability to continue to develop evidence to support the clinical utility of our tests; and (v) our ability to achieve near- and long-term success and the continued growth of our portfolio. The words "anticipate," "can," "could," "expect," "goal," "may," "plan" 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 continued reimbursement for our DecisionDx-SCC test at the current rate and reimbursement for our other 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, and our plans to research, develop and commercialize new tests and 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 and recession risks, supply chain disruptions, outbreaks of contagious diseases and geopolitical events (such as the ongoing Israel-Hamas War and Ukraine-Russia conflict), among others, on our business and our efforts to address its impact on our business; 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; actual application of our tests may not provide the aforementioned benefits to patients; our newer gastroenterology and mental health franchises 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, 2023 and our Quarterly Report on Form 10-Q for the quarter ended June 30, 2024, 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.
CASTLE BIOSCIENCES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(UNAUDITED)
(in thousands, except per share data)
Three Months Ended
June 30,
Six Months Ended
June 30,
2024
2023
2024
2023
NET REVENUES
$
87,002
$
50,138
$
159,976
$
92,175
OPERATING EXPENSES
Cost of sales (exclusive of amortization of acquired intangible asset)
14,519
11,058
28,413
21,240
Research and development
14,136
13,308
27,945
27,701
Selling, general and administrative
51,088
44,681
99,583
91,443
Amortization of acquired intangible asset
2,247
2,248
4,494
4,470
Total operating expenses, net
81,990
71,295
160,435
144,854
Operating income (loss)
5,012
(21,157
)
(459
)
(52,679
)
Interest income
3,144
2,399
6,140
4,735
Interest expense
(270
)
(3
)
(284
)
(7
)
Income (loss) before income taxes
7,886
(18,761
)
5,397
(47,951
)
Income tax (benefit) expense
(1,034
)
16
(989
)
30
Net income (loss)
$
8,920
$
(18,777
)
$
6,386
$
(47,981
)
Earnings (loss) per share:
Basic
$
0.32
$
(0.70
)
$
0.23
$
(1.80
)
Diluted
$
0.31
$
(0.70
)
$
0.22
$
(1.80
)
Weighted-average shares outstanding:
Basic
27,646
26,733
27,566
26,670
Diluted
28,738
26,733
28,542
26,670
Stock-Based Compensation Expense
Stock-based compensation expense is included in the unaudited condensed consolidated statements of operations as follows (in thousands):
Three Months Ended
June 30,
Six Months Ended
June 30,
2024
2023
2024
2023
Cost of sales (exclusive of amortization of acquired intangible assets)
$
1,401
$
1,202
$
2,715
$
2,474
Research and development
2,637
2,486
5,266
5,073
Selling, general and administrative
9,141
9,161
17,873
18,827
Total stock-based compensation expense
$
13,179
$
12,849
$
25,854
$
26,374
CASTLE BIOSCIENCES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS)
(UNAUDITED)
(in thousands)
Three Months Ended
June 30,
Six Months Ended
June 30,
2024
2023
2024
2023
Net income (loss)
$
8,920
$
(18,777
)
$
6,386
$
(47,981
)
Other comprehensive (loss) income:
Net unrealized (loss) gain on marketable investment securities
(61
)
(8
)
(308
)
237
Comprehensive income (loss)
$
8,859
$
(18,785
)
$
6,078
$
(47,744
)
CASTLE BIOSCIENCES, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
June 30,
2024
December 31,
2023
ASSETS
(unaudited)
Current Assets
Cash and cash equivalents
$
85,572
$
98,841
Marketable investment securities
174,116
144,258
Accounts receivable, net
45,988
38,302
Inventory
8,013
7,942
Prepaid expenses and other current assets
6,716
6,292
Total current assets
320,405
295,635
Long-term accounts receivable, net
1,125
1,191
Property and equipment, net
38,638
25,433
Operating lease assets
11,621
12,306
Goodwill and other intangible assets, net
112,840
117,335
Other assets – long-term
2,683
1,440
Total assets
$
487,312
$
453,340
LIABILITIES AND STOCKHOLDERS' EQUITY
Current Liabilities
Accounts payable
$
9,540
$
10,268
Accrued compensation
21,239
28,945
Operating lease liabilities
1,226
1,137
Other accrued and current liabilities
7,449
7,317
Total current liabilities
39,454
47,667
Long-term debt
10,008
—
Noncurrent operating lease liabilities
13,645
14,173
Noncurrent finance lease liabilities
312
25
Deferred tax liability
—
206
Total liabilities
63,419
62,071
Stockholders' Equity
Common stock
28
27
Additional paid-in capital
636,022
609,477
Accumulated deficit
(211,985
)
(218,371
)
Accumulated other comprehensive (loss) income
(172
)
136
Total stockholders' equity
423,893
391,269
Total liabilities, and stockholders' equity
$
487,312
$
453,340
CASTLE BIOSCIENCES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(UNAUDITED)
(in thousands)
Six Months Ended
June 30,
2024
2023
OPERATING ACTIVITIES
Net income (loss)
$
6,386
$
(47,981
)
Adjustments to reconcile net income (loss) to net cash provided by (used in) operating activities:
Depreciation and amortization
6,688
5,932
Stock-based compensation expense
25,854
26,374
Deferred income taxes
(1,542
)
13
Accretion of discounts on marketable investment securities
(3,422
)
(2,282
)
Other
83
213
Change in operating assets and liabilities:
Accounts receivable
(7,620
)
(7,978
)
Prepaid expenses and other current assets
(294
)
158
Inventory
(71
)
(2,141
)
Operating lease assets
678
(469
)
Other assets
143
(80
)
Accounts payable
(1,650
)
3,071
Operating lease liabilities
(432
)
958
Accrued compensation
(7,706
)
(7,060
)
Other accrued and current liabilities
68
2,047
Net cash provided by (used in) operating activities
17,163
(29,225
)
INVESTING ACTIVITIES
Purchases of property and equipment
(14,381
)
(7,373
)
Proceeds from sale of property and equipment
7
8
Purchases of marketable investment securities
(113,194
)
(86,438
)
Proceeds from maturities of marketable investment securities
86,450
95,000
Net cash (used in) provided by investing activities
(41,118
)
1,197
FINANCING ACTIVITIES
Proceeds from exercise of common stock options
73
184
Payment of employees' taxes on vested restricted stock units
(1,089
)
(848
)
Proceeds from contributions to the employee stock purchase plan
1,749
1,688
Repayment of principal portion of finance lease liabilities
(47
)
(70
)
Proceeds from issuance of term debt
10,000
—
Net cash provided by financing activities
10,686
954
NET CHANGE IN CASH AND CASH EQUIVALENTS
(13,269
)
(27,074
)
Beginning of period
98,841
122,948
End of period
$
85,572
$
95,874
CASTLE BIOSCIENCES, INC.
Reconciliation of Non-GAAP Financial Measures (UNAUDITED)
The table below presents the reconciliation of adjusted revenues and adjusted gross margin, which are non-GAAP financial measures. See "Use of Non-GAAP Financial Measures (UNAUDITED)" above for further information regarding the Company's use of non-GAAP financial measures.
Three Months Ended
June 30,
Six Months Ended
June 30,
2024
2023
2024
2023
(in thousands)
Adjusted revenues
Net revenues (GAAP)
$
87,002
$
50,138
$
159,976
$
92,175
Revenue associated with test reports delivered in prior periods
(363
)
88
(959
)
1,705
Adjusted revenues (Non-GAAP)
$
86,639
$
50,226
$
159,017
$
93,880
Adjusted gross margin
Gross margin (GAAP)1
$
70,236
$
36,832
$
127,069
$
66,465
Amortization of acquired intangible assets
2,247
2,248
4,494
4,470
Revenue associated with test reports delivered in prior periods
(363
)
88
(959
)
1,705
Adjusted gross margin (Non-GAAP)
$
72,120
$
39,168
$
130,604
$
72,640
Gross margin percentage (GAAP)2
80.7
%
73.5
%
79.4
%
72.1
%
Adjusted gross margin percentage (Non-GAAP)3
83.2
%
78.0
%
82.1
%
77.4
%
______________________
1.
Calculated as net revenues (GAAP) less the sum of cost of sales (exclusive of amortization of acquired intangible assets) and amortization of acquired intangible assets.
2.
Calculated as gross margin (GAAP) divided by net revenues (GAAP).
3.
Calculated as adjusted gross margin (Non-GAAP) divided by adjusted revenues (Non-GAAP).
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.
Three Months Ended
June 30,
Six Months Ended
June 30,
2024
2023
2024
2023
(in thousands)
Adjusted EBITDA
Net income (loss)
$
8,920
$
(18,777
)
$
6,386
$
(47,981
)
Interest income
(3,144
)
(2,399
)
(6,140
)
(4,735
)
Interest expense
270
3
284
7
Income tax (benefit) expense
(1,034
)
16
(989
)
30
Depreciation and amortization expense
3,348
3,040
6,688
5,932
Stock-based compensation expense
13,179
12,849
25,854
26,374
Adjusted EBITDA (Non-GAAP)
$
21,539
$
(5,268
)
$
32,083
$
(20,373
)
View source version on businesswire.Com: https://www.Businesswire.Com/news/home/20240805085135/en/
Contacts
Investor Relations Contact:Camilla Zuckeroczuckero@castlebiosciences.Com281-906-3868
Media Contact:Allison Marshallamarshall@castlebiosciences.Com
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What Is Stage 0 Breast Cancer?
Breast cancer usually doesn't have any symptoms, but getting regular screenings can help catch an early diagnosis. While stage 0 breast cancer isn't considered invasive, it may become invasive.
Stage 0 breast cancer, or ductal carcinoma in situ (DCIS), is when there are atypical cells in the lining of your milk ducts. But those cells have not spread beyond the wall of the duct to reach:
DCIS is noninvasive and is sometimes called "precancer." However, DCIS has the potential to become invasive.
In stage 1 breast cancer, the cancer is invasive. If it's small and contained to breast tissue, it's considered stage 1A, and if a small amount of cancer cells are found in your nearest lymph nodes, it's considered stage 1B.
As we explore stage 0 breast cancer, we're talking about DCIS, not stage 1 invasive breast cancer or lobular carcinoma in situ (LCIS).
In 2023, there were an estimated 297,790 new cases of invasive breast cancer in women in the U.S. In 2024, this number increased to 310,720.
About 30 percent of newly diagnosed cancers in women every year are attributed to breast cancer.
DCIS represents about 20-25 percent of all new diagnoses, according to a 2018 research review.
Stage 0 breast cancer used to include LCIS. Even though the name contains the word carcinoma, LCIS is no longer categorized as cancer.
LCIS involves atypical cells in your lobules, but they don't spread beyond your lobules.
LCIS is sometimes called "lobular neoplasia." It doesn't necessarily require treatment. However, LCIS can increase your risk of developing invasive cancer in the future, according to the American Cancer Society (ACS), so follow-up is important.
Which treatment you receive or your doctor recommends may depend on a few factors. Each case is different, so talk with your doctor about the benefits and risks of each type of treatment.
MastectomyMastectomy is not always necessary today. But some of the reasons to consider mastectomy are:
While mastectomy removes your entire breast, lumpectomy removes only the area of DCIS plus a small margin of tissue around it.
Lumpectomy is also called breast-conserving surgery or wide local excision. This preserves most of your breast, and you may not need breast reconstruction surgery.
The outlook is the same for those who undergo mastectomy compared to those who undergo a lumpectomy followed by radiation.
Radiation therapyRadiation therapy uses high-energy beams to destroy any atypical cells that may have been left behind after surgery. Most women typically do not need radiation following a mastectomy for DCIS, according to the ACS.
Radiation therapy for stage 0 breast cancer may follow a lumpectomy or mastectomy. It's often recommended after a lumpectomy. Treatments are given 5 days a week for several weeks.
Hormone therapyHormone therapy can be used to lower the chances of developing another DCIS or developing invasive cancer in either breast when taken for 5 years after surgery.
If the DCIS is hormone receptor-positive (HR+), your doctor may recommend treatment with tamoxifen or aromatase inhibitors, such as exemestane or anastrozole. Which therapy your doctor recommends may depend on whether you are past menopause.
Hormone therapy may increase life expectancy following breast cancer diagnosis for women who took the hormonal therapy for 5–10 years. Keep in mind this refers to all breast cancers, not just DCIS.
ChemotherapyChemotherapy is used to shrink tumors and destroy cancer cells throughout your body. Since stage 0 breast cancer is noninvasive, this systemic treatment is generally not necessary.
The exact cause of stage 0 breast cancer isn't clear, but the condition can be more common in people who have:
Some lifestyle factors can be modified to reduce your chances of developing the condition, including:
Contact your doctor if you have a lump or other changes to your breasts. Discuss your family history of cancer and ask how often you should be screened.
Stage 0 breast cancer is often found during mammogram screening. Following a suspicious mammogram, your doctor may order a diagnostic mammogram or another imaging test, such as an ultrasound.
If there's still some question about the suspicious area, you'll need a biopsy. Biopsy is the only way to diagnose cancer. For this, the doctor will use a needle to remove a tissue sample.
A pathologist will examine the tissue under a microscope and provide a report to your doctor. The pathology report will indicate whether atypical cells are present and, if so, how aggressive they may be.
When you learn you have stage 0 breast cancer, you have some big decisions to make.
It's important to talk with your doctor about your diagnosis in depth. Ask for clarification if you don't quite understand the diagnosis or your treatment options. You can also get a second opinion.
There's a lot to think about. If you're feeling anxious, stressed, or experiencing difficulty coping with the diagnosis and treatment, talk with your doctor. They can refer you to support services in your area.
You may also want to:
The ACS Support Programs and Services page provides information about resources, either online or in your area. You can also live chat with a representative or, if you're in the U.S., call the helpline at 1-800-227-2345.
Strategies to ease stress and anxiety include:
Stage 0 breast cancer can be very slow-growing and may never progress to invasive cancer. It can be successfully treated.
According to the ACS, women who have had DCIS are approximately 10 times more likely to develop invasive breast cancer than women who've never had DCIS.
In 2020, a cohort study looked at more than 140,000 women who had been treated for DCIS. Researchers saw the chance of death from breast cancer increased three-fold after diagnosis of DCIS.
For all this reason, your doctor may recommend screening more frequently if you have or have had DCIS.
Stage 0 breast cancer is considered noninvasive, but that doesn't mean it should be ignored. It has the potential to become invasive if left untreated.
Treatments can range f
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