Second quarter 2022 core Lung Diagnostic
revenue of $7.3 million increased 52% over the comparable period in
2021;
Received Medicare coverage for the Nodify CDT®
Lung Nodule Test;
Announced strategic arrangements during the
quarter (Royal Philips, Memorial Sloan Kettering Cancer Center and
Bio-Rad);
Reaffirm 2022 revenue outlook of between $37.5
million and $39.5 million;
Conference Call and Webcast Today at 8:00 a.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 second quarter ended June 30,
2022 and provided a corporate update.
“We are thrilled to announce strong growth from our core lung
diagnostic testing, with an increase in revenue of 52% over the
second quarter of 2021 and 56% over the first quarter of 2022,”
said Scott Hutton, CEO of Biodesix. “With the recent Medicare
coverage of the Nodify CDT® test, all five of our core lung
diagnostic tests are now covered, which will help drive adoption of
the test and improve margins over the long term.
In addition, we announced two exciting corporate arrangements.
The first, announced with Royal Phillips, integrates our Nodify
Lung® tests into its Lung Cancer Orchestrator patient management
system to help facilitate digital ordering of the tests following
detection of a lung nodule with the ultimate goal of improving
patient care and outcomes. The second, announced with Memorial
Sloan Kettering Cancer Center and Bio-Rad Laboratories, allows us
to leverage the capabilities of these leading organizations to
potentially bring new transformative diagnostics to market,
including our initial intention to co-develop a molecular minimal
residual disease (MRD) test for solid tumors.
Overall, our progress and positive trends in our core lung
diagnostics tests in the first half of the year solidifies our
confidence in reaffirming our 2022 revenue guidance.”
Second Quarter 2022 Financial Results
For the three-month period ended June 30, 2022, as compared
to the same period of 2021 (where applicable):
- Total revenue of $11.0 million, a decrease of 8%, driven
primarily by an anticipated year-over-year decline in COVID-19
diagnostic testing revenue, offset by strong year-over-year growth
in core lung diagnostics:
- Core lung diagnostic revenue of $7.3 million, reflected a
year-over-year increase of 52% that was driven primarily by the
increased adoption of Nodify Lung nodule management tests (Nodify
CDT & Nodify XL2 tests);
- COVID-19 testing revenue of $3.0 million reflected a
year-over-year decrease of 51% that was driven by the shift to
at-home rapid antigen testing;
- BioPharma Services revenue of $0.7 million decreased 29%
year-over-year. COVID-related delays in clinical study enrollment
and sample shipping logistics have begun to recover but are still
impacting timelines for existing and new agreements;
- Second quarter 2022 gross margin of $7.0 million, or 64% as a
percentage of revenue as compared to 40% in the comparable prior
year period primarily driven by the 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
$18.6 million, an increase of 21% driven primarily by growth in
sales and marketing to drive our growth in core lung diagnostics
sales as well as the recent GeneStrat NGS™ commercial launch;
- Includes non-cash stock compensation expense of $1.4 million as
compared to $0.5 million;
- Net loss of $15.8 million, an increase of 39%, driven primarily
by the loss on extinguishment charge resulting from the
restructuring of the contingent consideration agreement with
Integrated Diagnostics (Indi);
- Cash and cash equivalents of $28.7 million, inclusive of $5.1
million in restricted cash, as of June 30;
- Raised net proceeds of $27.3 million during the quarter through
debt and equity offerings;
- Includes principal payment of $3.0 million on the 2021 Term
Loan and $2.0 million for scheduled milestone payment in April 2022
to Indi.
2022 Financial Outlook
The Company reaffirms its 2022 financial outlook and expects to
generate between $37.5 million and $39.5 million in total revenue
in 2022.
Conference call and webcast information
Management will host an investor conference call and webcast
today, August 4, 2022 at 8:00 a.m. Eastern Time.
Investor dial-in (domestic):
800-715-9871
Investor dial-in (international):
646-307-1963
Conference ID:
8620846
Webcast:
https://edge.media-server.com/mmc/p/rf64jw58
An archived replay of the webcast will be available on the
Company’s website for a period of 90 days.
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 is the first
company to offer eight non-invasive 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® ddPCR™ test, the
GeneStrat NGS™ test and the VeriStrat® test to support treatment
decisions across all stages of lung cancer with results in an
unprecedented 36-72 hours, 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. Biodesix launched
the SARS-CoV-2 ddPCR™ test, the Platelia SARS-CoV-2 Total Ab, and
the cPass™ SARS-CoV-2 Neutralization Antibody test (cPass™
Neutralization Test Kit, GenScript, Inc,) in response to the global
pandemic and virus that impacts the lung and causes COVID-19. 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, it is 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 14, 2022 or subsequent quarterly reports on Form
10-Q during 2022, 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)
June 30, 2022
December 31, 2021
Assets
Current assets
Cash and cash equivalents
$
23,586
$
32,712
Accounts receivable, net of allowance for
doubtful accounts of $52 and $158
5,452
3,656
Other current assets
6,019
7,245
Total current assets
35,057
43,613
Non‑current assets
Restricted cash
5,000
—
Property and equipment, net
3,950
4,179
Intangible assets, net
10,688
11,617
Operating lease right-of-use assets
3,952
—
Goodwill
15,031
15,031
Other long-term assets
1,551
1,657
Total non‑current assets
40,172
32,484
Total assets
$
75,229
$
76,097
Liabilities and Stockholders'
Equity
Current liabilities
Accounts payable
$
1,791
$
1,662
Accrued liabilities
6,667
7,665
Deferred revenue
2,230
1,850
Current portion of operating lease
liabilities
1,315
—
Current portion of contingent
consideration
8,151
17,764
Current portion of notes payable
11,771
19
Other current liabilities
1,149
—
Total current liabilities
33,074
28,960
Non‑current liabilities
Long‑term notes payable, net of current
portion
8,596
9,993
Long-term operating lease liabilities
2,902
—
Contingent consideration
22,916
16,028
Other long-term liabilities
70
1,389
Total non‑current liabilities
34,484
27,410
Total liabilities
67,558
56,370
Commitments and contingencies
Stockholders' equity
Preferred stock, $0.001 par value,
5,000,000 shares authorized; 0 (2022 and 2021) shares issued and
outstanding
—
—
Common stock, $0.001 par value,
200,000,000 shares authorized; 39,978,844 (2022) and 30,789,649
(2021) shares issued and outstanding
40
31
Additional paid‑in capital
341,014
321,669
Accumulated deficit
(333,383
)
(301,973
)
Total stockholders' equity
7,671
19,727
Total liabilities and stockholders'
equity
$
75,229
$
76,097
Biodesix, Inc.
Condensed Statements of
Operations (unaudited)
(in thousands, except per
share data)
Three Months Ended June
30,
Six Months Ended June
30,
2022
2021
2022
2021
Revenues
COVID-19
$
2,954
$
6,064
$
3,938
$
29,296
Lung diagnostic
7,252
4,774
11,901
8,737
Diagnostic testing revenue
10,206
10,838
15,839
38,033
Biopharma services
744
1,047
1,659
2,718
Total revenues
10,950
11,885
17,498
40,751
Direct costs and expenses
3,980
7,085
7,215
25,303
Research and development
3,361
3,323
6,567
6,644
Sales, marketing, general and
administrative
15,235
11,425
29,722
23,352
Change in fair value of contingent
consideration
—
639
—
1,622
Impairment loss on intangible assets
—
—
81
—
Total operating expenses
22,576
22,472
43,585
56,921
Loss from operations
(11,626
)
(10,587
)
(26,087
)
(16,170
)
Other (expense) income:
Interest expense
(1,346
)
(815
)
(2,483
)
(1,466
)
Loss on extinguishment of liabilities
(2,952
)
—
(2,952
)
(728
)
Other income, net
100
—
112
1
Total other expense
(4,198
)
(815
)
(5,323
)
(2,193
)
Net loss
$
(15,824
)
$
(11,402
)
$
(31,410
)
$
(18,363
)
Net loss per share, basic and diluted
$
(0.40
)
$
(0.41
)
$
(0.89
)
$
(0.68
)
Weighted-average shares outstanding, basic
and diluted
39,239
27,730
35,177
27,020
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220804005042/en/
Media: Bobbi Coffin bobbi.coffin@biodesix.com (303)
892-3203 Investors: Chris Brinzey
chris.brinzey@westwicke.com (339) 970-2843
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