Persistent, high double-digit growth in Lung
Diagnostic test volume - growing 65% in FY2023 versus FY2022 - and
the sixth consecutive quarter with greater than 50% year-over-year
growth;
Ongoing improvement in gross profit margin with
achievement of 77% in fourth quarter 2023, up 11 points over fourth
quarter 2022;
2024 Total Revenue Guidance of $65 million to
$68 million;
Conference Call and Webcast Today at 8:30 a.m.
ET
Biodesix, Inc. (Nasdaq: BDSX), a leading diagnostic solutions
and services company, today provided a corporate update and
announced its financial and operating results for the fourth
quarter and year ended December 31, 2023 (fiscal 2023).
“I am exceptionally proud of the Biodesix team and our record of
accomplishments in 2023,” said Scott Hutton, CEO of Biodesix. “We
were focused on three goals: driving increased revenue through
adoption of our Lung Diagnostic tests and Biopharmaceutical
Services, implementing operational efficiencies to improve gross
margins, and maintaining a strict cost discipline. I am very
pleased with our significant progress on each of these goals.”
Mr. Hutton continued, “The Biodesix team delivered 65% growth in
Lung Diagnostic test volume for the full year 2023 and a sixth
straight quarter of over 50% year-over-year growth, with the fourth
quarter FY23 growing 54% over the fourth quarter of FY22. We made
tremendous progress driving Lung Diagnostic test adoption in 2023,
but we have just scratched the surface of a massive market
opportunity addressing a critical unmet need to help improve the
lives of patients with potentially cancerous lung nodules and lung
cancer with our five blood-based tests. At the same time, our focus
on growing Biodesix while maintaining a cost disciplined approach
has resulted in a dramatic 77% gross profit margin and 55%
improvement in Adjusted EBITDA in the fourth quarter FY23 compared
to the fourth quarter FY22, and a clear path towards profitability.
In 2024 we are committed to executing on those same three goals and
we expect to deliver $65 to $68 million in total revenue.”
Fourth Quarter and Full Year 2023 Financial Results
- Total revenue of $14.7 million and $49.1 million for the fourth
quarter and fiscal 2023, respectively, an increase of 52% and 49%
over the respective prior year comparable periods excluding COVID
testing revenues, and an increase of 53% and 28% over the
respective prior year comparable periods including COVID testing
revenues;
- Lung Diagnostic revenue of $12.8 million and $45.1 million for
the fourth quarter and fiscal 2023, respectively, an increase of
55% and 54% over the respective prior year comparable periods,
primarily driven by the continued adoption of Nodify Lung® Nodule
Risk Assessment tests;
- Biopharma Services and other revenue of $1.9 million and $3.9
million for the fourth quarter and fiscal 2023, respectively, an
increase of 38% and 6% over the respective prior year comparable
periods, a result of both delivering against our expanding book of
business and securing new agreements; entering 2024 with increasing
dollars under contract;
- Gross profit was $11.3 million or 77% and $36.1 million or 73%
for the fourth quarter and fiscal 2023, respectively, as a
percentage of revenue compared to 66% and 63% in the prior year
comparable periods, primarily driven by growth in Lung Diagnostic
testing and optimization of testing workflows that resulted in
improvements in costs per test, the ongoing recovery of our
Biopharma Services business, and the commercial discontinuation of
lower-margin COVID-19 testing;
- Operating expenses (excluding direct costs and expenses) of
$18.2 million and $77.4 million for the fourth quarter and fiscal
2023, a decrease of 10% and increase of 4% over the respective
prior year comparable periods;
- Decrease in fourth quarter 2023 is primarily attributable to a
decrease in research and development costs, partially offset by
increased sales and marketing costs to support Lung Diagnostic
sales growth, enhance product awareness and drive adoption, while
the full year increase in operating expenses was driven by an
increase in sales and marketing costs, partially offset by a
reduction in research and development costs;
- Includes non-cash stock compensation expense of $1.1 million
and $5.4 million during fourth quarter and fiscal 2023,
respectively, a decrease of 48% and 10% over the respective prior
year comparable periods;
- Net loss of $9.1 million and $52.1 million for the fourth
quarter and fiscal 2023, respectively, an improvement of 55% and
20% over the respective prior year comparable periods;
- Fourth quarter and fiscal 2023 included a gain of $0.1 million
and loss of $1.3 million, respectively, from the change in fair
value of warrant liabilities associated with our term loan facility
with Perceptive Advisors (Perceptive);
- Fourth quarter and fiscal 2022 included loss on debt
extinguishment and modification of $4.0 million and $7.0 million,
respectively;
- Adjusted EBITDA was a loss of $4.9 million and $32.7 million
for the fourth quarter and fiscal 2023, respectively, an
improvement of 55% and 24% over the respective prior year
comparable periods;
- Cash and cash equivalents of $26.3 million as of December 31,
2023;
- The Company successfully drew down the second tranche of $10
million from its $50 million term loan facility with Perceptive in
the fourth quarter of 2023;
- Cash balance includes the remaining $12.2 million of the $27.5
million private placement announced in August 2023.
2024 Financial Outlook
- The Company anticipates generating between $65 million to $68
million in total revenue in 2024, representing an approximate 32%
to 39% year-over-year growth rate.
Conference call and webcast information
Listeners can register for the webcast via this link. Analysts
wishing to participate in the question-and-answer session should
use this link. A replay of the webcast will be available via the
Company’s investor website approximately two hours after the call’s
conclusion. Those who plan on participating are advised to join 15
minutes prior to the start time.
For a full list of Biodesix press releases and webinars, please
visit the Investors Page on biodesix.com.
Use of Non-GAAP Financial Measure
Biodesix reported results are presented in accordance with
generally accepted accounting principles in the United States
(GAAP). Biodesix has provided in this press release financial
information that has not been prepared in accordance with GAAP.
Biodesix uses the non-GAAP financial measure, Adjusted
EBITDA, internally in analyzing its financial results and
believes that use of this non-GAAP financial measure is useful to
investors as an additional tool to evaluate ongoing operating
results and trends and in comparing Biodesix’s financial results
with other companies in its industry, many of which present similar
non-GAAP financial measures. Non-GAAP financial measures are not
meant to be considered in isolation or as a substitute for
comparable GAAP financial measures and should be read only in
conjunction with Biodesix’s financial statements prepared in
accordance with GAAP. A reconciliation of Biodesix historical
non-GAAP financial measure to the most directly comparable GAAP
measure has been provided in the financial statement tables
included in this press release, and investors are encouraged to
review the reconciliation.
Adjusted EBITDA is a key performance measure that our management
uses to assess our financial performance and is also used for
internal planning and forecasting purposes. We believe that this
non-GAAP financial measure is useful to investors and other
interested parties in analyzing our financial performance because
it provides a comparable overview of our operations across
historical periods. In addition, we believe that providing Adjusted
EBITDA, together with a reconciliation of Net loss to Adjusted
EBITDA, helps investors make comparisons between our Company and
other companies that may have different capital structures,
different tax rates, and/or different forms of employee
compensation.
Adjusted EBITDA is used by our management team as an additional
measure of our performance for purposes of business
decision-making, including managing expenditures. Period-to-period
comparisons of Adjusted EBITDA help our management identify
additional trends in our financial results that may not be shown
solely by period-to-period comparisons of Net loss or Loss from
operations. Our management recognizes that Adjusted EBITDA has
inherent limitations because of the excluded items and may not be
directly comparable to similarly titled metrics used by other
companies.
We calculate Adjusted EBITDA as Net loss adjusted to exclude
interest, income tax expense, if any, depreciation and
amortization, share-based compensation expense, loss on debt
extinguishments, net, COVID-19 revenue, COVID-19 direct costs and
expenses, change in fair value of warrant liabilities, net, other
income, net, and other non-recurring items. Non-recurring items are
excluded as they are not representative of our underlying operating
performance. We also exclude revenue and direct costs and expenses
associated with COVID-19 because we believe that these revenues and
expenses do not reflect expected future operating results as they
do not represent our Lung Diagnostic and Biopharma Services
business. Adjusted EBITDA should be viewed as a measure of
operating performance that is a supplement to, and not a substitute
for Loss from operations, Net loss, and other GAAP measures.
About Biodesix
Biodesix is a leading diagnostic solutions and services company
with a focus in lung disease. The Company develops diagnostic tests
addressing important clinical questions by combining multi-omics
through the power of artificial intelligence. Biodesix offers five
Medicare-covered tests for patients with lung diseases. The blood
based Nodify Lung® Nodule Risk Assessment testing strategy,
consisting of the Nodify XL2® and the Nodify CDT® tests, evaluates
the risk of malignancy in incidental pulmonary nodules, enabling
physicians to better triage patients to the most appropriate course
of action. The blood based IQLung™ strategy for lung cancer
patients integrates the GeneStrat® targeted ddPCR™ test, the
GeneStrat NGS® test and the VeriStrat® test to support treatment
decisions across all stages of lung cancer with results in an
average of two to three business days, expediting the time to
treatment. Biodesix also leverages the proprietary and advanced
Diagnostic Cortex® AI (Artificial Intelligence) platform, to
collaborate with many of the world’s leading biotechnology and
pharmaceutical companies to solve complex diagnostic challenges in
lung disease. For more information about Biodesix, visit
biodesix.com.
Note Regarding Forward-Looking Statements
This press release may contain forward-looking statements that
involve substantial risks and uncertainties for purposes of the
safe harbor provided by the Private Securities Litigation Reform
Act of 1995. All statements contained in this press release other
than statements of historical fact, are forward-looking statements.
The words “believe,” “may,” “will,” “estimate,” “continue,”
“anticipate,” “intend,” “plan,” “expect,” “predict,” “potential,”
“opportunity,” “goals,” or “should,” and similar expressions are
intended to identify forward-looking statements. Such statements
are based on management’s current expectations and involve risks
and uncertainties. Actual results and performance could differ
materially from those projected in the forward-looking statements
as a result of many factors. Biodesix has based these
forward-looking statements largely on its current expectations and
projections about future events and trends. These forward-looking
statements are subject to a number of risks, uncertainties, and
assumptions. Forward-looking statements may include information
concerning the impact of backlog and the timing and assumptions
regarding collection of revenues on projections, availability of
funds and future capital including under the term loan facility,
expectations regarding revenue and margin growth and its impact on
profitability, and the impact of a pandemic, epidemic, or outbreak,
including the COVID-19 pandemic, on Biodesix and its operations and
financial performance. Forward-looking statements are inherently
subject to risks and uncertainties, some of which cannot be
predicted or quantified. The Company's ability to continue as a
going concern could cause actual results to differ materially from
those contemplated in this press release and additionally, other
factors that could cause actual results to differ materially from
those contemplated in this press release can be found in the Risk
Factors section of Biodesix most recent annual report on Form 10-K,
filed March 1, 2024. Biodesix undertakes no obligation to revise or
publicly release the results of any revision to such
forward-looking statements, except as required by law. Given these
risks and uncertainties, readers are cautioned not to place undue
reliance on such forward-looking statements. All forward-looking
statements are qualified in their entirety by this cautionary
statement.
Biodesix, Inc.
Condensed Balance Sheets
(unaudited)
(in thousands, except share
data)
December 31, 2023
December 31, 2022
Assets
Current assets
Cash and cash equivalents
$
26,284
$
43,088
Accounts receivable, net of allowance for
doubtful accounts of $65 and $118
7,679
5,065
Other current assets
5,720
5,181
Total current assets
39,683
53,334
Non‑current assets
Property and equipment, net
27,867
5,848
Intangible assets, net
7,911
9,797
Operating lease right-of-use assets
1,745
2,973
Goodwill
15,031
15,031
Other long-term assets
6,859
5,923
Total non‑current assets
59,413
39,572
Total assets
$
99,096
$
92,906
Liabilities and Stockholders'
Equity
Current liabilities
Accounts payable
$
2,929
$
1,685
Accrued liabilities
7,710
8,218
Deferred revenue
324
962
Current portion of operating lease
liabilities
252
1,543
Current portion of contingent
consideration
21,857
10,341
Current portion of notes payable
51
49
Other current liabilities
293
41
Total current liabilities
33,416
22,839
Non‑current liabilities
Long‑term notes payable, net of current
portion
35,225
25,004
Long-term operating lease liabilities
25,163
5,254
Contingent consideration
—
18,645
Other long-term liabilities
712
558
Total non‑current liabilities
61,100
49,461
Total liabilities
94,516
72,300
Commitments and contingencies
Stockholders' equity
Preferred stock, $0.001 par value,
5,000,000 authorized; 0 (2023 and 2022) issued and outstanding
—
—
Common stock, $0.001 par value,
200,000,000 authorized; 96,235,883 (2023) and 77,614,358 (2022)
shares issued and outstanding
96
78
Additional paid‑in capital
424,050
387,948
Accumulated deficit
(419,566
)
(367,420
)
Total stockholders' equity
4,580
20,606
Total liabilities and stockholders'
equity
$
99,096
$
92,906
Biodesix, Inc.
Condensed Statements of
Operations (unaudited)
(in thousands, except per
share data)
Three Months Ended December
31,
Year Ended December
31,
2023
2022
2023
2022
Revenues
Lung Diagnostic
$
12,753
$
8,241
$
45,135
$
29,298
COVID-19
44
16
57
5,240
Diagnostic Testing revenue
12,797
8,257
45,192
34,538
Biopharma Services and other revenue
1,871
1,351
3,895
3,674
Total revenues
14,668
9,608
49,087
38,212
Direct costs and expenses
3,374
3,306
13,010
14,154
Research and development
1,889
3,565
9,988
13,102
Sales, marketing, general and
administrative
16,251
16,626
67,387
61,462
Impairment loss on intangible assets
24
—
44
81
Total operating expenses
21,538
23,497
90,429
88,799
Loss from operations
(6,870
)
(13,889
)
(41,342
)
(50,587
)
Other (expense) income:
Interest expense
(2,329
)
(2,550
)
(9,536
)
(8,072
)
Loss on debt extinguishments, net
—
(3,977
)
—
(6,981
)
Change in fair value of warrant liability,
net
58
84
(1,274
)
84
Other income, net
2
(5
)
6
109
Total other expense
(2,269
)
(6,448
)
(10,804
)
(14,860
)
Net loss
$
(9,139
)
$
(20,337
)
$
(52,146
)
$
(65,447
)
Net loss per share, basic and diluted
$
(0.10
)
$
(0.35
)
$
(0.64
)
$
(1.55
)
Weighted-average shares outstanding, basic
and diluted
92,325
57,805
82,113
42,103
Biodesix, Inc.
Reconciliation of Net Loss to
Adjusted EBITDA (unaudited)
(in thousands)
Three Months Ended December
31,
Year Ended December
31,
2023
2022
2023
2022
Net loss
$
(9,139
)
$
(20,337
)
$
(52,146
)
$
(65,447
)
Interest expense
2,329
2,550
9,536
8,072
Depreciation and amortization
977
898
3,328
3,597
Share-based compensation expense
1,081
2,077
5,373
5,961
Loss on debt extinguishments, net
—
3,977
—
6,981
COVID-19 Revenue
(44
)
(16
)
(57
)
(5,240
)
COVID-19 Direct costs and expenses
—
95
1
3,109
Change in fair value of warrant liability,
net
(58
)
(84
)
1,274
(84
)
Other income, net
(2
)
5
(6
)
(109
)
Adjusted EBITDA
$
(4,856
)
$
(10,835
)
$
(32,697
)
$
(43,160
)
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240301670433/en/
Media: Natalie St. Denis Director, Corporate
Communications natalie.stdenis@biodesix.com (720) 925-9285
Investors: Chris Brinzey chris.brinzey@westwicke.com
(339) 970-2843
Grafico Azioni Biodesix (NASDAQ:BDSX)
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Da Nov 2024 a Dic 2024
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