First quarter 2023 Core Lung
Diagnostic revenue of $8.6 million increased 86% over the
comparable period in 2022;
Record number of Core Lung Diagnostic tests
delivered in Company history;
Conference Call and Webcast Today at 4:30 p.m.
ET
Biodesix, Inc. (Nasdaq: BDSX), a leading data-driven diagnostic
solutions company with a focus in lung disease, today announced its
financial and operating results for the first quarter ended March
31, 2023 and provided a corporate update.
“Throughout the quarter we continued to make excellent progress
and I am pleased with the start to the year. Looking at our
financial performance, we reported total revenue of $9.1 million
for the first quarter 2023, which represents growth of 38% compared
to the first quarter of 2022, while core lung diagnostic revenue of
$8.6 million grew by 86% over the comparable period,” said Scott
Hutton, President and Chief Executive Officer. “Importantly, the
momentum seen in the first quarter and the continued growth in our
core lung diagnostic testing business clearly indicates the
clinical need and growing acceptance of our on-market tests.”
First Quarter 2023 Financial Results
For the three-month period ended March 31, 2023, as compared
to the same period of 2022 (where applicable):
- Total revenue of $9.1 million, an increase of 38%, driven
primarily by strong year-over-year growth in core lung diagnostics:
- Core lung diagnostic revenue of $8.6 million reflected a
year-over-year increase of 86% driven primarily by the continued
adoption of Nodify Lung® nodule management tests;
- BioPharma Services revenue of $0.4 million decreased 55%
year-over-year. Timelines for existing and new agreements continue
to be impacted by delayed enrollment in clinical trials; entered
the second quarter of 2023 with continued strong dollars under
contract;
- COVID-19 testing revenue decreased by 99% year-over-year, and
consistent with our revenue guidance. In connection with the
expected expiration of the Public Health Emergency declaration, the
Company will no longer provide COVID-19 diagnostic testing services
commercially;
- First quarter 2023 gross profit of $5.9 million, or 65% gross
margin as compared to 51% gross margin in the comparable prior year
period primarily driven by the mix shift of sales to higher-margin
core lung diagnostics and away from lower-margin COVID-19
testing;
- Operating expenses (excluding direct costs and expenses) of
$22.3 million, an increase of approximately $4.5 million, or 25% as
compared to the first quarter 2022 (includes non-cash stock
compensation expense of $2.3 million as compared to $1.3 million);
- Approximately $3.0 million of the increase was attributable to
increased sales and marketing costs to support core lung diagnostic
sales growth including growth in the sales force, increased
travel-related costs, and marketing programs to enhance product
awareness;
- Approximately $1.6 million was associated with increased
general and administrative expenses primarily associated with
non-cash stock compensation costs;
- Net loss of $18.7 million and basic and diluted net loss per
share of $0.24;
- Cash and cash equivalents of $25.3 million as of March 31,
2023;
- Scheduled milestone payment of $2.2 million paid in January
2023 to Integrated Diagnostics.
2023 Financial Outlook
The Company reaffirms our 2023 financial outlook and expects to
generate between $52 million and $55 million in total revenue in
2023.
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’s press releases and webinars,
please visit biodesix.com.
About Biodesix
Biodesix is a leading data-driven diagnostic solutions 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 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 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 the COVID-19 pandemic on Biodesix and its
operations, its possible or assumed future results of operations,
including descriptions of its revenues, profitability, outlook, and
overall business strategy. 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’s most recent annual report on Form
10-K, filed March 6, 2023 or subsequent quarterly reports on Form
10-Q during 2023, if applicable. 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)
March 31, 2023
December 31, 2022
Assets
Current assets
Cash and cash equivalents
$
25,275
$
43,088
Accounts receivable, net of allowance for
doubtful accounts of $200 and $118
4,901
5,065
Other current assets
4,608
5,181
Total current assets
34,784
53,334
Non‑current assets
Property and equipment, net
13,097
5,848
Intangible assets, net
9,311
9,797
Operating lease right-of-use assets
2,194
2,973
Goodwill
15,031
15,031
Other long-term assets
6,376
5,923
Total non‑current assets
46,009
39,572
Total assets
$
80,793
$
92,906
Liabilities and Stockholders'
Equity
Current liabilities
Accounts payable
$
1,563
$
1,685
Accrued liabilities
5,740
8,218
Deferred revenue
1,133
962
Current portion of operating lease
liabilities
1,762
1,543
Current portion of contingent
consideration
11,706
10,341
Current portion of notes payable
50
49
Other current liabilities
144
41
Total current liabilities
22,098
22,839
Non‑current liabilities
Long‑term notes payable, net of current
portion
25,084
25,004
Long-term operating lease liabilities
12,039
5,254
Contingent consideration
16,374
18,645
Other long-term liabilities
648
558
Total non‑current liabilities
54,145
49,461
Total liabilities
76,243
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; 77,979,376 (2023) and 77,614,358 (2022)
shares issued and outstanding
78
78
Additional paid‑in capital
390,594
387,948
Accumulated deficit
(386,122
)
(367,420
)
Total stockholders' equity
4,550
20,606
Total liabilities and stockholders'
equity
$
80,793
$
92,906
Biodesix, Inc.
Condensed Statements of
Operations (unaudited)
(in thousands, except per
share data)
Three Months Ended March
31,
2023
2022
Revenues
COVID-19
$
13
$
984
Lung diagnostic
8,632
4,649
Diagnostic testing revenue
8,645
5,633
Biopharma services
411
915
Total revenues
9,056
6,548
Direct costs and expenses
3,169
3,235
Research and development
3,251
3,206
Sales, marketing, general and
administrative
18,989
14,487
Impairment loss on intangible assets
20
81
Total operating expenses
25,429
21,009
Loss from operations
(16,373
)
(14,461
)
Other (expense) income:
Interest expense
(2,391
)
(1,137
)
Change in fair value of warrant
liability
61
—
Other income, net
1
12
Total other expense
(2,329
)
(1,125
)
Net loss
$
(18,702
)
$
(15,586
)
Net loss per share, basic and diluted
$
(0.24
)
$
(0.50
)
Weighted-average shares outstanding, basic
and diluted
77,765
31,070
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230511005218/en/
Media: Robin Harper Cowie robin.cowie@biodesix.com (720)
509-8841
Investors: Chris Brinzey chris.brinzey@westwicke.com
(339) 970-2843
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