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 second quarter and six months ended June 30, 2020.
"While our second quarter financial results reflect COVID-19 impacts, thanks to the strong execution by our employees, we continue to successfully navigate these challenging times," said Derek Maetzold, Castle's president and chief executive officer. "We have seen a notable improvement in DecisionDx®-Melanoma orders since April's low, with sequential gains throughout the quarter leading to a year-over-year increase in June and continued year-over-year gains in July. Additionally, we maintained strong gross margins and delivered positive operating cash flow for the quarter.
"With the publication of multiple peer-reviewed articles, we saw significant evidence development, including publication of two systematic reviews and meta-analyses regarding Decision-Dx Melanoma. Evidence development supports both clinician adoption and payor coverage of our commercially available tests, DecisionDx-Melanoma and DecisionDx®-UM, and our pipeline tests. Additionally, as we continue to position ourselves for near- and long-term growth, we are moving forward with our planned commercial team expansion in the second half of 2020.
"We are pleased with the continued progress of our pipeline tests, which importantly allows us to expand our services for patients who are diagnosed with early stage skin cancers. We plan for DecisionDx-SCC, our pipeline test for patients with high-risk cutaneous squamous cell carcinoma (SCC), to be commercially available at the beginning of September. DecisionDx-SCC is designed to identify a patient's risk of metastasis, in order to enable more informed, risk-appropriate clinical decisions regarding adjuvant therapy and other management options.
"In addition, our team completed the clinical validation work needed to launch our pipeline test for use in suspicious pigmented lesions, and as previously stated, we expect this test to become commercially available in the second half of 2020. We estimate that combined, our three skin cancer products, DecisionDx-Melanoma, DecisionDx-SCC and our test for suspicious pigmented lesions, will have a total addressable U.S. market of approximately $2.0 billion."
Second Quarter Ended June 30, 2020, Selected Results
Six Months Ended June 30, 2020, Selected Results
Cash and Cash Equivalents
As of June 30, 2020, the Company's cash and cash equivalents totaled $179.8 million, which includes net proceeds of approximately $69.5 million from the Company's June 2020 public offering of 2,000,000 shares of common stock. On July 2, 2020, the Company announced that the underwriters of the public offering exercised in full their option to purchase an additional 300,000 shares of common stock. The additional net proceeds were approximately $10.4 million.
As of June 30, 2020, the outstanding principal balance on the Company's bank term loan was $25.9 million.
COVID-19 Update
Since the beginning of the pandemic to date, the Company has maintained uninterrupted access to its proprietary DecisionDx-Melanoma test and DecisionDx-UM test and has maintained normal turnaround times for delivery of test reports. Based upon an analysis of the Company's supply channel and current inventory levels, the Company believes it has adequate access to reagents and consumables needed for testing patient samples and expects to continue providing normal turnaround times for delivery of test reports.
In the second quarter of 2020, the number of DecisionDx-Melanoma test reports the Company delivered decreased by 19%, compared to the same quarter of 2019. Additionally, COVID-19 negatively impacted clinician orders of the Company's DecisionDx-Melanoma test, which the Company believes is linked to delays and/or cancellations in patient visits, resulting in reduced diagnostic biopsies and thus reduced diagnoses of cutaneous melanoma. The largest impact was seen in April, improving sequentially throughout the remainder of the quarter. Specifically:
The year-over-year increase of monthly DecisionDx-Melanoma orders continued in July 2020. In light of COVID-19, the Company believes this order data provides additional insight into current demand trends when considered in conjunction with test report volumes. However, orders received in a particular period do not necessarily correspond with actual delivered test reports or reported revenues for the same period or subsequent periods.
In the second quarter of 2020, COVID-19 negatively impacted the Company's year-over-year number of new ordering clinicians for DecisionDx-Melanoma. The largest impact was seen in April, improving sequentially throughout the remainder of the quarter. The improvement, over April figures, of the Company's year-over-year number of new ordering clinicians for DecisionDx-Melanoma continued in July 2020.
The Company believes the improvement observed in DecisionDx-Melanoma test orders since April is driven in part by the reopening of dermatology practices and rescheduled patient visits, which have generally coincided with the easing of state and local government restrictions.
The COVID-19 pandemic's impact on the Company's future test report volumes, operating results, cash flows, results of operations and/or financial condition, among other things, will be primarily driven by such variables as the pandemic's severity, duration and the impact of state and local government restrictions on the U.S. healthcare system, which the Company is unable to predict or control.
Supplemental Revenue Information
Included in revenue for the quarter ended June 30, 2020, were positive revenue adjustments related to tests delivered in prior periods of $2.3 million. This compares to positive adjustments of $3.3 million for the quarter ended June 30, 2019. For the six months ended June 30, 2020 and 2019, these amounts totaled $1.0 million and $2.8 million, respectively. The positive revenue adjustments include the recognition of revenue for certain tests delivered in prior periods for which no revenue was recognizable originally but was recognized upon cash collection of payments for the tests in the applicable periods.
Second Quarter Business and Clinical Evidence Highlights
Recent Business and Clinical Evidence Updates
Conference Call and Webcast Details
Castle Biosciences will hold a conference call on Monday, August 10, 2020, at 4:30 p.m. Eastern time to discuss its second quarter 2020 results and provide a corporate update.
A live webcast of the conference call can be accessed here: https://edge.media-server.com/mmc/p/itxfzvjn or via the webcast link on the Investor Relations page of the Company's website (www.castlebiosciences.com). 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 31, 2020.
To access the live conference call via phone, please dial 877-282-2581 from the United States and Canada, or +1 470-495-9479 internationally, at least 10 minutes prior to the start of the call, using the conference ID 7388802.
There will be a brief Question & Answer session following management commentary.
Use of Non-GAAP Financial Measures (UNAUDITED)
In this release, we use the metric of Adjusted Operating Cash Flow, which is a non-GAAP financial measure and is not calculated in accordance with generally accepted accounting principles in the United States (GAAP). This non-GAAP financial measure reflects adjustments to net cash provided by operating activities to remove the effects of two payments we received associated with government aid to healthcare providers due to COVID-19, which we believe are not indicative of our ongoing operations.
We use Adjusted Operating Cash Flow internally because we believe this metric provides useful supplemental information in assessing our cash flow performance from our core ongoing business activities by removing the effects of these items on our operating cash flows. We believe this metric is also useful to investors as a supplement to GAAP measures in analyzing the performance of our business. However, this non-GAAP financial measure 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. This non-GAAP financial measure is not meant to be a substitute for net cash provided by operating activities reported in accordance with GAAP and should be considered in conjunction with our financial information presented on GAAP basis. Accordingly, investors should not place undue reliance on non-GAAP financial measures. Reconciliations of this non-GAAP financial measure to the most directly comparable GAAP financial measure are presented in the table at the end of this press release.
About Castle Biosciences, Inc.
Castle Biosciences (Nasdaq: CSTL) is a commercial-stage dermatologic cancer company focused on providing physicians and their patients with personalized, clinically actionable genomic information to make more accurate treatment decisions. The Company currently offers tests for patients with cutaneous melanoma (DecisionDx®-Melanoma, DecisionDx®-CMSeq; www.SkinMelanoma.com) and uveal melanoma (DecisionDx®-UM, DecisionDx®-PRAME and DecisionDx®- UMSeq; www.MyUvealMelanoma.com), with products in development for other underserved cancers, the two most advanced of which are focused on patients with cutaneous squamous cell carcinoma, and patients who have a difficult-to-diagnose pigmented lesion. Castle Biosciences is based in Friendswood, Texas (Houston), and has laboratory operations in Phoenix, Arizona. For more information, visit www.CastleBiosciences.com.
Forward-Looking Statements
The information in this press release contains forward-looking statements and information 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 the effects of the COVID-19 pandemic on our business and our efforts to address its impact on our business, statements concerning the expected commercial availability of our pipeline products, the impact of our tests, including DecisionDx-Melanoma and DecisionDx-SCC, on patient treatment plans, expectations regarding reopening of dermatology practices or rescheduled patient visits, our prospects and plans and the objectives of management. The words "anticipates," "believes," "estimates," "expects," "intends," "may," "plans," "projects," "will," "would" 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, the effects of the COVID-19 pandemic on our business and our efforts to address its impact on our business and our ability to maintain compliance with the covenants in our debt facility, the timing and amount of revenue we are able to recognize in a given fiscal period, unexpected delays in planned launch of our pipeline products, the level and availability of reimbursement for our products, our ability to manage our anticipated growth and the risks set forth in our Annual Report on Form 10-K for the year ended December 31, 2019, filed on March 10, 2020, our Quarterly Report on Form 10-Q for the quarter ended June 30, 2020, 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.
The COVID-19 situation continues to evolve and brings along with it a high level of uncertainty surrounding potential future impacts. Therefore, trends in test report volumes, order data and new ordering clinician data is not necessarily indicative of the Company's results of operations that can be expected for future interim periods or for the year ending December 31, 2020.
CASTLE BIOSCIENCES, INC. |
||||||||||||||||
CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS |
||||||||||||||||
(UNAUDITED) |
||||||||||||||||
(in thousands, except per share data) |
||||||||||||||||
|
Three Months Ended
|
|
Six Months Ended
|
|||||||||||||
|
2020 |
|
2019 |
|
2020 |
|
2019 |
|||||||||
|
|
|
|
|
|
|
|
|||||||||
NET REVENUES |
$ |
12,715 |
|
|
$ |
10,739 |
|
|
$ |
30,133 |
|
|
$ |
19,456 |
|
|
COST OF SALES |
2,146 |
|
|
1,993 |
|
|
4,537 |
|
|
3,591 |
|
|||||
Gross margin |
10,569 |
|
|
8,746 |
|
|
25,596 |
|
|
15,865 |
|
|||||
OPERATING EXPENSES AND OTHER OPERATING INCOME |
|
|
|
|
|
|
|
|||||||||
Research and development |
2,704 |
|
|
1,317 |
|
|
5,617 |
|
|
2,711 |
|
|||||
Selling, general and administrative |
10,392 |
|
|
6,821 |
|
|
21,470 |
|
|
12,868 |
|
|||||
Other operating income |
(1,882 |
) |
|
? |
|
(1,882 |
) |
|
? |
|||||||
Total operating expenses, net |
11,214 |
|
|
8,138 |
|
|
25,205 |
|
|
15,579 |
|
|||||
Operating income (loss) |
(645 |
) |
|
608 |
|
|
391 |
|
|
286 |
|
|||||
Interest income |
38 |
|
|
5 |
|
|
336 |
|
|
26 |
|
|||||
Interest expense |
(769 |
) |
|
(1,693 |
) |
|
(1,533 |
) |
|
(2,717 |
) |
|||||
Other expense, net |
? |
|
(189 |
) |
|
? |
|
(222 |
) |
|||||||
Loss before income taxes |
(1,376 |
) |
|
(1,269 |
) |
|
(806 |
) |
|
(2,627 |
) |
|||||
Income tax expense |
? |
|
? |
|
? |
|
? |
|||||||||
Net loss and comprehensive loss |
(1,376 |
) |
|
(1,269 |
) |
|
(806 |
) |
|
(2,627 |
) |
|||||
Convertible preferred stock cumulative dividends |
? |
|
939 |
|
|
? |
|
1,867 |
|
|||||||
Accretion of redeemable convertible preferred stock to redemption value |
? |
|
57 |
|
|
? |
|
113 |
|
|||||||
Net loss and comprehensive loss attributable to common stockholders |
$ |
(1,376 |
) |
|
$ |
(2,265 |
) |
|
$ |
(806 |
) |
|
$ |
(4,607 |
) |
|
|
|
|
|
|
|
|
|
|||||||||
Loss per share attributable to common stockholders: |
|
|
|
|
|
|
|
|||||||||
Basic |
$ |
(0.08 |
) |
|
$ |
(1.05 |
) |
|
$ |
(0.05 |
) |
|
$ |
(2.26 |
) |
|
Diluted |
$ |
(0.08 |
) |
|
$ |
(1.05 |
) |
|
$ |
(0.05 |
) |
|
$ |
(2.26 |
) |
|
Weighted-average shares outstanding: |
|
|
|
|
|
|
|
|||||||||
Basic |
17,544 |
|
|
2,153 |
|
|
17,458 |
|
|
2,036 |
|
|||||
Diluted |
17,544 |
|
|
2,153 |
|
|
17,458 |
|
|
2,036 |
|
CASTLE BIOSCIENCES, INC. |
||||||||
CONDENSED BALANCE SHEETS |
||||||||
(in thousands) |
||||||||
|
June 30, |
|
December 31, |
|||||
|
2020 |
|
2019 |
|||||
|
(unaudited) |
|
|
|||||
ASSETS |
|
|
|
|||||
Current Assets |
|
|
|
|||||
Cash and cash equivalents |
$ |
179,759 |
|
|
$ |
98,845 |
|
|
Accounts receivable, net |
12,528 |
|
|
14,648 |
|
|||
Inventory |
1,667 |
|
|
1,237 |
|
|||
Prepaid expenses and other current assets |
1,717 |
|
|
1,951 |
|
|||
Total current assets |
195,671 |
|
|
116,681 |
|
|||
Long-term accounts receivable, net |
652 |
|
|
870 |
|
|||
Property and equipment, net |
5,024 |
|
|
2,060 |
|
|||
Other assets ? long-term |
199 |
|
|
135 |
|
|||
Total assets |
$ |
201,546 |
|
|
$ |
119,746 |
|
|
|
|
|
|
|||||
LIABILITIES AND STOCKHOLDERS' EQUITY |
|
|
|
|||||
Current Liabilities |
|
|
|
|||||
Accounts payable |
$ |
2,495 |
|
|
$ |
1,865 |
|
|
Accrued compensation |
4,651 |
|
|
5,779 |
|
|||
Medicare advance payment |
8,350 |
|
|
? |
|
|||
Other accrued liabilities |
2,746 |
|
|
1,812 |
|
|||
Current portion of long-term debt |
10,000 |
|
|
5,833 |
|
|||
Total current liabilities |
28,242 |
|
|
15,289 |
|
|||
Long-term debt |
14,741 |
|
|
19,289 |
|
|||
Deferred rent liability and other |
941 |
|
|
55 |
|
|||
Total liabilities |
43,924 |
|
|
34,633 |
|
|||
Stockholders' Equity |
|
|
|
|||||
Common stock |
19 |
|
|
17 |
|
|||
Additional paid-in capital |
210,621 |
|
|
137,308 |
|
|||
Accumulated deficit |
(53,018 |
) |
|
(52,212 |
) |
|||
Total stockholders' equity |
157,622 |
|
|
85,113 |
|
|||
Total liabilities and stockholders' equity |
$ |
201,546 |
|
|
$ |
119,746 |
|
CASTLE BIOSCIENCES, INC. |
|||||||||
CONDENSED STATEMENTS OF CASH FLOWS |
|||||||||
(UNAUDITED) |
|||||||||
(in thousands) |
|||||||||
|
Six Months Ended
|
||||||||
|
2020 |
|
2019 |
||||||
OPERATING ACTIVITIES |
|
|
|
||||||
Net loss |
$ |
(806 |
) |
|
$ |
(2,627 |
) |
|
|
Adjustments to reconcile net loss to net cash provided by operating activities: |
|
|
|
||||||
Depreciation |
193 |
|
|
163 |
|
|
|||
Stock compensation expense |
3,230 |
|
|
307 |
|
|
|||
Amortization of intangibles |
? |
|
4 |
|
|
||||
Amortization of debt discounts and issuance costs |
452 |
|
|
1,250 |
|
|
|||
Change in fair value of preferred stock warrant liability |
? |
|
86 |
|
|
||||
Change in fair value of embedded derivative |
? |
|
136 |
|
|
||||
Change in operating assets and liabilities: |
|
|
|
||||||
Accounts receivable |
2,337 |
|
|
3,625 |
|
|
|||
Prepaid expenses and other current assets |
234 |
|
|
(99 |
) |
|
|||
Inventory |
(430 |
) |
|
331 |
|
|
|||
Other assets |
(62 |
) |
|
(11 |
) |
|
|||
Accounts payable |
444 |
|
|
(524 |
) |
|
|||
Accrued compensation |
(1,127 |
) |
|
(1,786 |
) |
|
|||
Medicare advance payment |
8,350 |
|
|
? |
|
||||
Other accrued liabilities |
263 |
|
|
902 |
|
|
|||
Deferred rent liability and other |
172 |
|
|
13 |
|
|
|||
Net cash provided by operating activities |
13,250 |
|
|
1,770 |
|
|
|||
INVESTING ACTIVITIES |
|
|
|
||||||
Purchases of property and equipment |
(2,256 |
) |
|
(424 |
) |
|
|||
Net cash used in investing activities |
(2,256 |
) |
|
(424 |
) |
|
|||
FINANCING ACTIVITIES |
|
|
|
||||||
Proceeds from public offering of common stock, net of underwriting discounts, commissions and offering costs |
69,530 |
|
|
? |
|
||||
Proceeds from issuance of convertible promissory notes, net of issuance costs |
? |
|
11,695 |
|
|
||||
Proceeds from issuance of term debt, net of issuance costs |
? |
|
1,776 |
|
|
||||
Repayments on term debt |
(833 |
) |
|
? |
|
||||
Repayments on line of credit |
? |
|
(1,791 |
) |
|
||||
Payments of deferred offering costs |
? |
|
(454 |
) |
|
||||
Proceeds from exercise of common stock options |
400 |
|
|
417 |
|
|
|||
Proceeds from contributions to the employee stock purchase plan |
823 |
|
|
? |
|
||||
Net cash provided by financing activities |
69,920 |
|
|
11,643 |
|
|
|||
NET CHANGE IN CASH AND CASH EQUIVALENTS |
80,914 |
|
|
12,989 |
|
|
|||
Beginning of period |
98,845 |
|
|
4,479 |
|
|
|||
End of period |
$ |
179,759 |
|
|
$ |
17,468 |
|
|
CASTLE BIOSCIENCES, INC.
Reconciliation of Non-GAAP Financial Measures (UNAUDITED)
The table below presents the reconciliation of adjusted operating cash flow, which is a non-GAAP 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
|
|
Six Months Ended
|
|||||||||||||
|
2020 |
|
2019 |
|
2020 |
|
2019 |
|||||||||
(in thousands) |
|
|
|
|
|
|
|
|||||||||
Adjusted operating cash flow |
|
|
|
|
|
|
|
|||||||||
Adjusted operating cash flow (Non-GAAP) |
$ |
3,269 |
|
|
$ |
482 |
|
|
$ |
3,018 |
|
|
$ |
1,770 |
|
|
Receipt of Medicare advance payment1 |
8,350 |
|
|
? |
|
|
8,350 |
|
|
? |
|
|||||
Receipt of HHS provider relief funds2 |
1,882 |
|
|
? |
|
|
1,882 |
|
|
? |
|
|||||
Net cash provided by operating activities (GAAP) |
$ |
13,501 |
|
|
$ |
482 |
|
|
$ |
13,250 |
|
|
$ |
1,770 |
|
__________________ | ||
1 |
In April 2020, we received an advance payment of $8.3 million from the Centers for Medicare & Medicaid Service (CMS), which will be applied against future Medicare claims that we submit for reimbursement later in 2020. We recorded the receipt of the payment as a liability on our balance sheet and, in accordance with GAAP, it is included in net cash provided by operating activities in the period received. We have excluded receipt of the advance payment from adjusted operating cash flow, but as future claims are submitted for reimbursement and applied against this balance, we will include the advance payment in adjusted operating cash flow to the extent that Medicare claims submitted for reimbursement have been applied to the balance. |
|
2 |
In April 2020, we received a one-time payment of $1.9 million in relief funds automatically allocated to Medicare providers under the Coronavirus Aid, Relief and Economic Security Act (CARES Act) from the U.S. Department of Health and Human Services (HHS). |
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