Q1 2024 revenue increased 74% over Q1 2023 to
$73 million
Q1 2024 total test reports increased 40% over
Q1 2023
Raising full-year 2024 revenue guidance to
$255-265 million from $235-240 million
Conference call and webcast today at 4:30 p.m.
ET
Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving
health through innovative tests that guide patient care, today
announced its financial results for the first quarter ended March
31, 2024.
“The first quarter marked an excellent start to the year with
strong execution across the company, resulting in outstanding
revenue and volume growth across our therapeutic areas,” said Derek
Maetzold, president and chief executive officer of Castle
Biosciences. “These results underscore the dedication of our
talented team to improving patient care and the strength of our
diverse test portfolio.
“Additionally, we continue to develop evidence to support the
clinical utility of our tests. We are especially pleased with three
peer-reviewed studies published since the beginning of 2024 that
focus on our DecisionDx®-SCC test. The studies demonstrate that
DecisionDx-SCC can improve risk stratification when used in
conjunction with staging, to help predict responsiveness to
adjuvant radiation therapy (ART) and when used in conjunction with
clinicopathologic factors in considering use of ART, can
potentially lead to net annual Medicare healthcare savings of up to
approximately $972 million. These studies have been submitted to
our Medicare Contractors for their review.
“Our DecisionDx®-Melanoma test informs two questions: which
patients can consider foregoing a sentinel lymph node biopsy (SLNB)
surgical procedure, and what is the risk of recurrence so the most
appropriate follow-up treatment plan can be implemented. It is of
high importance that when a test identifies patients with a low
likelihood of a positive SLNB, and thus they could forego this
surgical procedure, the patients also have a low risk of metastatic
outcomes. The data from our recent prospective, multicenter study
show just that – SLNB-eligible patients who had a
DecisionDx-Melanoma Class 1A (lowest risk) test result and made the
decision with their physician to forego an SLNB had excellent
outcomes during the follow-up period. We believe it is this kind of
evidence that should be required in order for clinicians to safely
adopt a molecular test that rules out an SLNB surgical
procedure.
“Looking ahead, we are raising our 2024 total revenue guidance
to $255-265 million, up from the previously provided guidance of
$235-240 million, reflecting our excellent start to 2024 and
continued confidence in the business. We believe the positive
momentum we generated in the first quarter sets a solid foundation
for continued executional success throughout the year.”
First Quarter Ended March 31, 2024, Financial and Operational
Highlights
- Revenues were $73.0 million, a 74% increase compared to $42.0
million 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 quarter were $1.7 million
of net positive revenue adjustments, compared to $1.3 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 $71.3
million, a 64% increase compared to $43.4 million for the same
period in 2023.
- Delivered 20,888 total test reports in the first quarter of
2024, an increase of 40% compared to 14,916 in the same period of
2023:
- DecisionDx-Melanoma test reports delivered in the quarter were
8,384 compared to 7,583 in the first quarter of 2023, an increase
of 11%.
- DecisionDx-SCC test reports delivered in the quarter were 3,577
compared to 2,411 in the first quarter of 2023, an increase of
48%.
- MyPath® Melanoma test reports delivered in the quarter were
998, compared to 980 MyPath Melanoma and DiffDx®-Melanoma aggregate
test reports in the first quarter of 2023, an increase of 2%.
- TissueCypher® Barrett’s Esophagus test reports delivered in the
quarter were 3,429 compared to 1,383 in the first quarter of 2023,
an increase of 148%.
- IDgenetix® test reports delivered in the quarter were 4,078
compared to 2,150 in the first quarter of 2023, an increase of
90%.
- DecisionDx®-UM test reports delivered in the quarter were 422,
compared to 409 in the first quarter of 2023, an increase of
3%.
- Gross margin was 78%, and Adjusted Gross Margin was 81%,
compared to 71% and 77%, respectively, for the same periods in
2023.
- Net cash used in operations was $6.8 million, compared to net
cash used in operations of $25.4 million for the same period in
2023.
- Net loss, which includes non-cash stock-based compensation
expense of $12.7 million, was $2.5 million, compared to a net loss
of $29.2 million for the same period in 2023.
- Adjusted EBITDA was $10.5 million, compared to $(15.1) million
for the same period in 2023.
Cash, Cash Equivalents and Marketable Investment
Securities
As of March 31, 2024, the Company’s cash, cash equivalents and
marketable investment securities totaled $239.2 million.
2024 Outlook
Castle Biosciences is increasing its guidance for anticipated
total revenue in 2024. The Company now anticipates generating
between $255-265 million in total revenue in 2024, compared to the
previously provided guidance of between $235-240 million.
First Quarter and Recent Accomplishments and
Highlights
Dermatology
- DecisionDx-SCC: A new study was published, titled “Inconsistent
associations between risk factor profiles and adjuvant radiation
therapy (ART) treatment in patients with cutaneous squamous cell
carcinoma and utility of the 40-gene expression profile to refine
ART guidance.” The study showed that in addition to providing
risk-stratification information, our DecisionDx-SCC test identified
patients most likely to benefit from ART and those who can consider
deferring treatment given a lower likelihood of benefit.
- DecisionDx-SCC: Related to the ART study mentioned above, the
Company also announced the publication of a health economic study
which found that guiding ART using DecisionDx-SCC results can lead
to substantial Medicare healthcare savings of up to approximately
$972 million annually. This net cost reduction focused on the added
cost of DecisionDx-SCC and the direct cost of ART in those patients
who could consider avoiding ART. See the Company’s news release
from Jan. 18, 2024, for more information.
- DecisionDx-SCC: The Company announced the publication of a new
multicenter performance study of its DecisionDx-SCC risk
stratification test. The study analyzed the independent performance
of DecisionDx-SCC from risk factors and traditional staging systems
(i.e., Brigham and Women’s Hospital and American Joint Committee on
Cancer Staging Manual 8th Edition (AJCC8) staging), and
demonstrated significantly improved predictive accuracy when the
test’s results were integrated with the staging systems and
National Comprehensive Cancer Network® (NCCN) guidelines to guide
risk-appropriate treatment pathway decisions that can improve
patient outcomes. See the Company’s news release from March 7,
2024, for more information.
- DecisionDx-SCC: The Company also saw publication of an expert
consensus article related to the utility of its DecisionDx-SCC test
in clinical decision-making regarding the use of ART. The consensus
guidelines outline a recommended risk-based workflow that
integrates DecisionDx-SCC and AJCC8 staging into current NCCN
guidelines to improve precision in ART recommendations based on
which patients are at the highest risk for metastasis and most
likely to benefit from treatment. See the Company’s news release
from March 19, 2024, for more information.
- DecisionDx-Melanoma: The Company announced the publication of a
study demonstrating that DecisionDx-Melanoma provided significantly
better risk stratification than AJCC8 staging in patients with
stage I cutaneous melanoma. This study reports the results of two
large stage I cohorts, including 5,561 patients from the National
Cancer Institute’s Surveillance, Epidemiology and End Results
(SEER) Program Registries. It suggests that incorporating the
DecisionDx-Melanoma test into clinical practice may help clinicians
and patients with stage I melanoma obtain more precise information
about a patient’s risk of disease progression to inform more
personalized, risk-aligned treatment and surveillance management
plans. See the Company’s news release from Feb. 26, 2024, for more
information.
- DecisionDx-Melanoma: An oral presentation from a multicenter,
prospective, U.S. based study examining the performance of
DecisionDx-Melanoma in safely ruling out an SLNB showed that of
patients with a T1-T2 melanoma and predicted to have a <5%
likelihood of a positive SLN, no patients had a positive node. The
DecisionDx-Melanoma test had a negative predictive value of 100%
and, of clinical importance, outcome data with a median follow up
time of two years showed 100% recurrence free survival; meaning
that no patients experienced a recurrence in the study period. This
data was presented at the Society of Surgical Oncology 2024 Annual
Meeting. See the Company’s news release from March 22, 2024, for
more information.
Mental Health
- In March 2024, the Company announced new data highlighting the
value of its IDgenetix pharmacogenomic (PGx) test in guiding
medication recommendations for patients who are 65 and older with
mental health conditions. Specifically, the study data showed that
one-third of the IDgenetix-guided medication recommendations were
due to drug-drug interactions and lifestyle factors, demonstrating
the value of this additional information in guiding selection of
neuropsychiatric medications for older adults in patients 65 and
older, with majority being on five or more medications at the time
of testing. See the Company’s news release from March 15, 2024, for
more information.
Conference Call and Webcast Details
Castle Biosciences will hold a conference call on Thursday, May
2, 2024, at 4:30 p.m. Eastern time to discuss its first quarter
2024 results and provide a corporate update.
A live webcast of the conference call can be accessed here:
https://events.q4inc.com/attendee/562496463 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 May 23, 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 112983.
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 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 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)
the potential of our tests to improve patient outcomes, including
increased survival; (ii) our continued commercial momentum in 2024;
(iii) our ability to continue to develop evidence to support the
clinical utility of our tests; (iv) the ability of DecisionDx-SCC
to improve risk stratification to help predict responsiveness to
ART and lead to net annual Medicare healthcare savings of up to
approximately $972 million; (v) our 2024 total revenue guidance of
$255-265 million; and (vi) the ability of the DecisionDx-Melanoma
test to help clinicians and patients with stage I melanoma obtain
more precise information about a patient’s risk of disease
progression and to inform more personalized, risk-aligned treatment
and surveillance management plans. 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 March 31, 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 March
31,
2024
2023
NET REVENUES
$
72,974
$
42,037
OPERATING EXPENSES
Cost of sales (exclusive of amortization
of acquired intangible asset)
13,894
10,182
Research and development
13,809
14,393
Selling, general and administrative
48,495
46,762
Amortization of acquired intangible
asset
2,247
2,222
Total operating expenses, net
78,445
73,559
Operating loss
(5,471
)
(31,522
)
Interest income
2,996
2,336
Interest expense
(14
)
(4
)
Loss before income taxes
(2,489
)
(29,190
)
Income tax expense
45
14
Net loss
$
(2,534
)
$
(29,204
)
Loss per share, basic and diluted
$
(0.09
)
$
(1.10
)
Weighted-average shares outstanding, basic
and diluted
27,485
26,607
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 March
31,
2024
2023
Cost of sales (exclusive of amortization
of acquired intangible assets)
$
1,314
$
1,272
Research and development
2,629
2,587
Selling, general and administrative
8,732
9,666
Total stock-based compensation expense
$
12,675
$
13,525
CASTLE BIOSCIENCES,
INC.
CONDENSED CONSOLIDATED
STATEMENTS OF COMPREHENSIVE LOSS
(UNAUDITED)
(in thousands)
Three Months Ended March
31,
2024
2023
Net loss
$
(2,534
)
$
(29,204
)
Other comprehensive (loss)
income:
Net unrealized (loss) gain on marketable
investment securities
(247
)
245
Comprehensive loss
$
(2,781
)
$
(28,959
)
CASTLE BIOSCIENCES,
INC.
CONDENSED CONSOLIDATED BALANCE
SHEETS
(in thousands)
March 31, 2024
December 31, 2023
ASSETS
(unaudited)
Current Assets
Cash and cash equivalents
$
82,949
$
98,841
Marketable investment securities
156,264
144,258
Accounts receivable, net
42,699
38,302
Inventory
7,645
7,942
Prepaid expenses and other current
assets
6,221
6,292
Total current assets
295,778
295,635
Long-term accounts receivable, net
1,056
1,191
Property and equipment, net
32,904
25,433
Operating lease assets
11,961
12,306
Goodwill and other intangible assets,
net
115,088
117,335
Other assets – long-term
1,720
1,440
Total assets
$
458,507
$
453,340
LIABILITIES AND STOCKHOLDERS’
EQUITY
Current Liabilities
Accounts payable
$
9,318
$
10,268
Accrued compensation
14,708
28,945
Operating lease liabilities
1,189
1,137
Other accrued and current liabilities
6,744
7,317
Total current liabilities
31,959
47,667
Long-term debt
10,000
—
Noncurrent operating lease liabilities
13,864
14,173
Deferred tax liability
206
206
Other liabilities
16
25
Total liabilities
56,045
62,071
Stockholders’ Equity
Common stock
28
27
Additional paid-in capital
623,450
609,477
Accumulated deficit
(220,905
)
(218,371
)
Accumulated other comprehensive (loss)
income
(111
)
136
Total stockholders’ equity
402,462
391,269
Total liabilities, and stockholders’
equity
$
458,507
$
453,340
CASTLE BIOSCIENCES,
INC.
CONDENSED CONSOLIDATED
STATEMENTS OF CASH FLOWS
(UNAUDITED)
(in thousands)
Three Months Ended March
31,
2024
2023
OPERATING ACTIVITIES
Net loss
$
(2,534
)
$
(29,204
)
Adjustments to reconcile net loss to net
cash used in operating activities:
Depreciation and amortization
3,340
2,892
Stock-based compensation expense
12,675
13,525
Deferred income taxes
—
13
Accretion of discounts on marketable
investment securities
(1,699
)
(1,229
)
Other
179
211
Change in operating assets and
liabilities:
Accounts receivable
(4,262
)
(4,383
)
Prepaid expenses and other current
assets
(103
)
(654
)
Inventory
297
(540
)
Operating lease assets
338
331
Other assets
(230
)
319
Accounts payable
(422
)
3,896
Operating lease liabilities
(250
)
(68
)
Accrued compensation
(14,237
)
(11,562
)
Other accrued and current liabilities
73
1,014
Net cash used in operating activities
(6,835
)
(25,439
)
INVESTING ACTIVITIES
Purchases of property and equipment
(9,152
)
(3,338
)
Proceeds from sale of property and
equipment
5
5
Purchases of marketable investment
securities
(60,754
)
(30,083
)
Proceeds from maturities of marketable
investment securities
50,200
50,000
Net cash (used in) provided by investing
activities
(19,701
)
16,584
FINANCING ACTIVITIES
Proceeds from exercise of common stock
options
65
95
Payment of employees’ taxes on vested
restricted stock units
(474
)
(314
)
Proceeds from contributions to the
employee stock purchase plan
1,089
982
Repayment of principal portion of finance
lease liabilities
(36
)
(35
)
Proceeds from issuance of term debt
10,000
— c
Net cash provided by financing
activities
10,644
728
NET CHANGE IN CASH AND CASH
EQUIVALENTS
(15,892
)
(8,127
)
Beginning of period
98,841
122,948
End of period
$
82,949
$
114,821
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 March
31,
2024
2023
(in thousands)
Adjusted
revenues
Net revenues (GAAP)
$
72,974
$
42,037
Revenue associated with test reports
delivered in prior periods
(1,656
)
1,336
Adjusted revenues (Non-GAAP)
$
71,318
$
43,373
Adjusted gross
margin
Gross margin (GAAP)1
$
56,833
$
29,633
Amortization of acquired intangible
assets
2,247
2,222
Revenue associated with test reports
delivered in prior periods
(1,656
)
1,336
Adjusted gross margin (Non-GAAP)
$
57,424
$
33,191
Gross margin percentage (GAAP)2
77.9
%
70.5
%
Adjusted gross margin percentage
(Non-GAAP)3
80.5
%
76.5
%
_______________
- 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.
- Calculated as gross margin (GAAP) divided by net revenues
(GAAP).
- 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 March
31,
2024
2023
(in thousands)
Adjusted
EBITDA
Net loss
$
(2,534
)
$
(29,204
)
Interest income
(2,996
)
(2,336
)
Interest expense
14
4
Income tax expense
45
14
Depreciation and amortization expense
3,340
2,892
Stock-based compensation expense
12,675
13,525
Adjusted EBITDA (Non-GAAP)
$
10,544
$
(15,105
)
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240502534307/en/
Investor Relations Contact: Camilla Zuckero
czuckero@castlebiosciences.com 281-906-3868
Media Contact: Allison Marshall
amarshall@castlebiosciences.com
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