Q2 2024 revenue grew 51% over Q2 2023 to $17.9
million;
Q2 2024 gross profit margin of 78.4%, a 5.7%
improvement from Q2 2023;
Raises full-year 2024 revenue guidance to
$70-72 million from $65-68 million;
Q2 24 Net loss, including certain non-cash
items, and Adjusted EBITDA improved by 19% and 38% over Q2
2023;
Conference Call and Webcast Today at 4:30 p.m.
ET
Biodesix, Inc. (Nasdaq: BDSX), a leading diagnostic solutions
company, today announced its financial and operating results for
the second quarter ended June 30, 2024.
“The second quarter marks sustained excellence in our execution,
resulting in outstanding revenue growth coupled with consistently
strong gross margins, and continued improvement on our path to
profitability,” said Scott Hutton, CEO of Biodesix. “The team’s
performance led to 51% growth in revenue and as a result we are
raising our 2024 total revenue guidance to $70-$72 million, up from
previously provided guidance of $65-$68 million. In combination
with our revenue growth, our cost-disciplined approach resulted in
improvements of 19% in Net Loss and 38% in Adjusted EBITDA,
demonstrating progress on our path to profitability.”
“It is important to note that our industry-leading commercial
engine is continuing to drive market adoption of our five on-market
lung diagnostic tests. These tests are transforming the diagnosis
and treatment of patients with lung cancer. We have an incredible
team of professionals dedicated and driven to making a difference
in patients’ lives. I continue to be thankful for the team and our
intentional focus on workplace culture so that we attract and
retain the best talent.”
Second Quarter Ended June 30, 2024 Business
Highlights
- Named to Inc. Magazine’s 2024 Best Workplaces list. The ranking
is based on a comprehensive, data- driven measurement process
through anonymous employee surveys to identify which American
companies have excelled in creating high-engagement workplaces and
excellent company cultures.
- Grew Lung Diagnostic test volume to 13,900, a 42% improvement
over the second quarter of 2023 and 17% over the first quarter of
2024.
- Quarterly gross profit margin of 78.4% versus 72.7% for the
second quarter of 2023 and 78.6% for the first quarter of
2024.
- Presented compelling new data1 at the American Thoracic Society
(ATS) Conference, May 2024, that highlighted the Nodify XL2 test
and its ability to identify benign nodules in patients with
emphysema, demonstrating further test utility in patients with
common comorbidities.
- Peer-reviewed data was published in June in the Annals of
Oncology2 that highlight the role of Biodesix diagnostic services
in monitoring efficacy of new therapeutic regimens.
Second Quarter Ended June 30, 2024 Financial
Highlights
- Total revenue of $17.9 million, an increase of 51% over the
second quarter 2023. This results in now eight consecutive quarters
of over 40% revenue growth and is driven by strong year-over-year
growth in both lines of business:
- Lung Diagnostic revenue of $16.5 million reflected a
year-over-year increase of 44% driven primarily by the continued
adoption of Nodify Lung® nodule risk assessment tests;
- Biopharmaceutical Services of $1.4 million increased
228% year-over-year, a result of both delivering against the
Company’s book of contracted business and securing new
agreements;
- Second quarter 2024 gross profit of $14.0 million, or 78.4%
gross margin compared to 72.7% gross margin in the comparable prior
year period, primarily driven by growth in Lung Diagnostic testing
and optimization of testing workflows that resulted in improvements
in costs per test, and increased process efficiencies in the
Company’s Biopharmaceutical Services business;
- Operating expenses (excluding direct costs and expenses) of
$22.3 million, an increase of approximately $2.7 million, or 14% as
compared to the second quarter 2023 (includes $2.7 million of
non-cash stock compensation expense, depreciation and amortization,
and asset impairment as compared to $1.9 million). This increase is
primarily attributable to an increase in sales and marketing costs
to support lung diagnostic sales growth to enhance product
awareness and drive adoption, an increase in depreciation expense
related to the leasehold improvements in the Company’s new
Louisville, Colorado offices and laboratory, partially offset by a
decrease in research and development and general and administrative
costs;
- Net loss of $10.8 million, an improvement of approximately $2.5
million, or 19% as compared to the same period of 2023. Net loss
included $0.6 million of one-time cash and non-cash Other Expenses,
net primarily related to our probability of not utilizing the
Lincoln Park Capital Equity Line of Credit prior to expiration and
costs associated with debt-extinguishment;
- Adjusted EBITDA was a loss of $5.6 million, an improvement of
$3.5 million, or 38% over the second quarter of 2023 and fifth
straight quarter of year-over-year improvement in Adjusted
EBITDA;
- Cash and cash equivalents of $42.2 million as of June 30, 2024,
an increase of $30.7 million from March 31, 2024;
- Cash and cash equivalents as of June 30, 2024, includes $55.0
million in gross proceeds raised from an oversubscribed and upsized
offering of common stock and concurrent private placement completed
on April 5, 2024.
- Includes the second quarter scheduled milestone payment of $5.3
million and pre-payment of the third quarter $8.4 million scheduled
milestone payment paid in April 2024 for the acquisition of
Integrated Diagnostics in 2018. The pre-payment of the third
quarter milestone resulted in cash savings from interest that was
eliminated by the pre-payment. The Company has one final payment of
$6.1 million remaining, which does not accrue interest and is
expected to be paid at the end of the third quarter 2024.
2024 Financial Outlook
The Company is increasing its 2024 revenue forecast and now
expects to generate between $70 million and $72 million in total
revenue in 2024, versus prior guidance of $65 million and $68
million in total revenue in 2024.
Conference call and webcast information
Listeners can register for the webcast via this link. Analysts
who wish 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 relations page on the website approximately two
hours after the call’s conclusion. Participants are advised to join
15 minutes prior to the start time.
For a full list of Biodesix press releases and webinars, please
visit biodesix.com.
About Biodesix
Biodesix is a leading diagnostic solutions company with five
Medicare-covered tests available for patients with lung diseases.
The blood-based Nodify Lung® Nodule Risk Assessment, 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™ test portfolio 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 and expedite personalized treatment. In
addition, Biodesix collaborates with the world’s leading
biopharmaceutical companies to provide biomarker discovery,
diagnostic test development, and clinical trial support services.
For more information about Biodesix, visit biodesix.com.
The Biodesix logo, Biodesix, Nodify Lung, Nodify XL2, Nodify
CDT, IQLung, GeneStrat, GeneStrat NGS, and VeriStrat are trademarks
or registered trademarks of Biodesix, Inc. The ddPCR technology is
a trademark of Bio-Rad Laboratories, Inc.
Footnotes:
1. Performance comparison of blood-based integrated classifier
for lung nodule risk stratification in patients with versus without
emphysema. American Thoracic Society, May 2024. Dr. Romera,
University of Nevada, Las Vegas.
2. “Amivantamab plus lazertinib versus osimertinib in first-line
EGFR-mutant advanced non-small-cell lung cancer with biomarkers of
high-risk disease: a secondary analysis from MARIPOSA,” Annals of
Oncology, June 2024.
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 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 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 Biopharmaceutical 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.
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 or subsequent quarterly reports on Form 10-Q
during 2024, 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, 2024
December 31, 2023
Assets
Current assets
Cash and cash equivalents
$
42,219
$
26,284
Accounts receivable, net of allowance for
credit losses of $238 and $65
10,128
7,679
Other current assets
5,232
5,720
Total current assets
57,579
39,683
Non-current assets
Property and equipment, net
28,019
27,867
Intangible assets, net
6,884
7,911
Operating lease right-of-use assets
1,767
1,745
Goodwill
15,031
15,031
Other long-term assets
6,561
6,859
Total non-current assets
58,262
59,413
Total assets
$
115,841
$
99,096
Liabilities and Stockholders'
Equity
Current liabilities
Accounts payable
$
2,220
$
2,929
Accrued liabilities
8,324
7,710
Deferred revenue
447
324
Current portion of operating lease
liabilities
300
252
Current portion of contingent
consideration
5,838
21,857
Current portion of notes payable
37
51
Other current liabilities
386
293
Total current liabilities
17,552
33,416
Non-current liabilities
Long-term notes payable, net of current
portion
35,807
35,225
Long-term operating lease liabilities
25,478
25,163
Other long-term liabilities
744
712
Total non-current liabilities
62,029
61,100
Total liabilities
79,581
94,516
Commitments and contingencies
Stockholders' equity
Preferred stock, $0.001 par value,
5,000,000 authorized; 0 (2024 and 2023) issued and outstanding
—
—
Common stock, $0.001 par value,
200,000,000 authorized; 145,149,630 (2024) and 96,235,883 (2023)
shares issued and outstanding
145
96
Additional paid-in capital
480,103
424,050
Accumulated deficit
(443,988
)
(419,566
)
Total stockholders' equity
36,260
4,580
Total liabilities and stockholders'
equity
$
115,841
$
99,096
Biodesix, Inc.
Condensed Statements of
Operations (unaudited)
(in thousands, except per
share data)
Three Months Ended
June 30,
Six Months Ended
June 30,
2024
2023
2024
2023
Revenues
Diagnostic Testing revenue
$
16,539
$
11,449
$
30,335
$
20,094
Biopharmaceutical Services and other
revenue
1,386
423
2,408
834
Total revenues
17,925
11,872
32,743
20,928
Direct costs and expenses
3,877
3,238
7,052
6,407
Research and development
2,558
2,910
4,598
6,161
Sales, marketing, general and
administrative
19,660
16,651
40,216
35,640
Impairment loss on intangible assets
67
—
135
20
Total operating expenses
26,162
22,799
52,001
48,228
Loss from operations
(8,237
)
(10,927
)
(19,258
)
(27,300
)
Other (expense) income:
Interest expense
(1,936
)
(2,430
)
(4,465
)
(4,821
)
Loss on extinguishment of liabilities
(248
)
—
(248
)
—
Change in fair value of warrant liability,
net
—
—
—
61
Other (expense) income, net
(387
)
1
(451
)
2
Total other expense
(2,571
)
(2,429
)
(5,164
)
(4,758
)
Net loss
$
(10,808
)
$
(13,356
)
$
(24,422
)
$
(32,058
)
Net loss per share, basic and diluted
$
(0.08
)
$
(0.17
)
$
(0.22
)
$
(0.41
)
Weighted-average shares outstanding, basic
and diluted
127,168
78,506
112,167
78,138
Biodesix, Inc.
Reconciliation of Net Loss to
Adjusted EBITDA (unaudited)
(in thousands)
Three Months Ended June
30,
Six Months Ended June
30,
2024
2023
2024
2023
Net loss
$
(10,808
)
$
(13,356
)
$
(24,422
)
$
(32,058
)
Interest expense
1,936
2,430
4,465
4,821
Depreciation and amortization
1,412
784
2,832
1,569
Share-based compensation expense
1,218
1,057
3,858
3,338
Loss on extinguishment of liabilities
248
—
248
—
COVID-19 Revenue
—
—
—
(13
)
COVID-19 Direct costs and expenses
—
—
—
1
Change in fair value of warrant liability,
net
—
—
—
(61
)
Other expense (income), net
387
(1
)
451
(2
)
Adjusted EBITDA
$
(5,607
)
$
(9,086
)
$
(12,568
)
$
(22,405
)
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240807088406/en/
Media: Natalie St. Denis natalie.stdenis@biodesix.com
(720) 925-9285
Investors: Chris Brinzey chris.brinzey@westwicke.com
(339) 970-2843
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