Biodesix, Inc. (Nasdaq: BDSX), a leading diagnostic solutions
company, today announced its financial and operating results for
the third quarter ended September 30, 2024.
“The Biodesix team is pleased to report another
solid quarter focused on executing and delivering on our three main
goals - driving revenue growth through the adoption of our lung
diagnostic tests and biopharma services, continued implementation
of operational efficiencies, and maintaining a cost-disciplined
approach as we drive our business to profitability,” said Scott
Hutton, CEO of Biodesix.
“We reported 40% year-over-year growth in lung
diagnostics revenue, a growing book of biopharma services
contracts, sustained gross margins in the high 70% range, and
improved Net Loss on our path to profitability. In addition, at the
annual meeting of the American College of Chest Physicians (CHEST),
we presented new clinical data on our Nodify XL2® and Nodify CDT®
tests, and announced a new clinical study (CLARIFY) to expand our
data in diverse patient populations tested in a real-world clinical
setting. Building on this momentum, we are reiterating our prior
guidance of $70-$72 million for 2024 and we look forward to
achieving Adjusted EBITDA profitability in the second half of 2025.
At Biodesix, our tests play a vital role in treating the deadliest
of all cancers. Our committed and driven team embraces the
opportunity, and the responsibility, to transform the standard of
care to improve outcomes for patients.”
Third Quarter Ended September 30, 2024
Business Highlights
- Grew Lung
Diagnostic test volume to 13,900, a 34% improvement over the third
quarter of 2023.
- Quarterly gross
profit margin of 77.0% versus 76.1% for the third quarter of
2023.
- Presented
compelling new data at the CHEST Annual Meeting and announced the
launch of a new clinical study, CLARIFY.
- New data was
presented detailing the experience of healthcare providers using
the Nodify Lung® Nodule Risk Assessment Tests (Nodify XL2 and
Nodify CDT tests) in over 35,000 patients tested in a real-world
clinical setting. Results shared were consistent with prior
studies, highlighting the high proportion of results that up- or
down-classify patients into actionable risk categories with clear,
guideline-recommended, diagnostic plans.
- The new study,
CLARIFY, is designed to confirm performance of the Nodify CDT and
Nodify XL2 tests in diverse patient subgroups through a
retrospective chart review of up to 4,000 patients that were tested
in a real-world clinical setting. The study’s intent is to expand
the extensive evidence characterizing the validation and utility of
Nodify Lung testing.
Third Quarter Ended September 30, 2024
Financial Highlights
- Total revenue of
$18.2 million, an increase of 35% over the third quarter 2023:
- Lung
Diagnostic revenue of $17.2 million reflected a
year-over-year increase of 40% driven by the continued adoption of
Nodify XL2 and Nodify CDT nodule risk assessment tests and strong
reimbursement. However, test volumes were impacted at the end of
the third quarter by disruption to patients, healthcare providers,
and Biodesix teammates in the southeast due to Hurricane
Helene;
-
Biopharmaceutical Services revenue of $1.0 million
decreased 17% year-over-year, driven by the timing of receipt of
samples and shift of the completion of certain projects from the
end of the third quarter into the beginning of the fourth;
- Third quarter 2024
gross profit of $14.0 million, or 77.0% gross margin compared to
76.1% gross margin in the comparable prior year period. Our steady
margin performance is primarily driven by volume growth in Lung
Diagnostic testing that continues to drive down the per test
costs;
- Operating expenses
(excluding direct costs and expenses) of $22.6 million, an increase
of 29% as compared to the third quarter 2023, which includes $3.0
million of non-cash stock compensation expense and depreciation and
amortization as compared to $1.7 million in third quarter of 2023.
This increase is primarily attributable to an increase in sales and
marketing costs to support both business lines’ sales growth to
enhance product awareness and drive adoption, and an increase in
depreciation expense related to the leasehold improvements in the
Company’s Louisville, CO offices and laboratory which opened in
January 2024;
- Net loss of $10.3
million, an improvement of 6% as compared to the same period of
2023;
- Adjusted EBITDA was
a loss of $5.6 million, a slight increase over the loss of $5.4
million in the third quarter of 2023 and consistent with the second
quarter of 2024;
- Cash and cash
equivalents of $31.4 million as of September 30, 2024, a decrease
from $42.2 million from June 30, 2024;
- Cash and cash
equivalents as of September 30, 2024 includes the final milestone
payment of $6.1 million for the acquisition of Integrated
Diagnostics in 2018.
2024 - 2025 Financial
Outlook
The Company is reiterating the 2024 revenue
forecast of between $70 million and $72 million.
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.
Trademarks: 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.
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.
Contacts:Media:Natalie St.
Denisnatalie.stdenis@biodesix.com(720) 925-9285
Investors:Chris
Brinzeychris.brinzey@westwicke.com(339) 970-2843
Biodesix, Inc.Condensed Balance Sheets
(unaudited)(in thousands, except share
data) |
|
|
|
|
|
|
September 30, 2024 |
|
|
December 31, 2023 |
|
Assets |
|
Current assets |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
31,406 |
|
|
$ |
26,284 |
|
Accounts receivable, net of allowance for credit losses of $246 and
$65 |
|
|
8,036 |
|
|
|
7,679 |
|
Other current assets |
|
|
4,575 |
|
|
|
5,720 |
|
Total current assets |
|
|
44,017 |
|
|
|
39,683 |
|
Non-current assets |
|
|
|
|
|
|
Property and equipment, net |
|
|
28,683 |
|
|
|
27,867 |
|
Intangible assets, net |
|
|
6,438 |
|
|
|
7,911 |
|
Operating lease right-of-use assets |
|
|
1,918 |
|
|
|
1,745 |
|
Goodwill |
|
|
15,031 |
|
|
|
15,031 |
|
Other long-term assets |
|
|
6,656 |
|
|
|
6,859 |
|
Total non-current assets |
|
|
58,726 |
|
|
|
59,413 |
|
Total assets |
|
$ |
102,743 |
|
|
$ |
99,096 |
|
|
|
|
|
|
|
|
Liabilities and Stockholders' Equity |
|
Current liabilities |
|
|
|
|
|
|
Accounts payable |
|
$ |
2,537 |
|
|
$ |
2,929 |
|
Accrued liabilities |
|
|
8,553 |
|
|
|
7,710 |
|
Deferred revenue |
|
|
676 |
|
|
|
324 |
|
Current portion of operating lease liabilities |
|
|
624 |
|
|
|
252 |
|
Current portion of contingent consideration |
|
|
— |
|
|
|
21,857 |
|
Current portion of notes payable |
|
|
29 |
|
|
|
51 |
|
Other current liabilities |
|
|
544 |
|
|
|
293 |
|
Total current liabilities |
|
|
12,963 |
|
|
|
33,416 |
|
Non-current liabilities |
|
|
|
|
|
|
Long-term notes payable, net of current portion |
|
|
36,112 |
|
|
|
35,225 |
|
Long-term operating lease liabilities |
|
|
25,191 |
|
|
|
25,163 |
|
Other long-term liabilities |
|
|
620 |
|
|
|
712 |
|
Total non-current liabilities |
|
|
61,923 |
|
|
|
61,100 |
|
Total liabilities |
|
|
74,886 |
|
|
|
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; 145,465,941
(2024) and 96,235,883 (2023) shares issued and outstanding |
|
|
145 |
|
|
|
96 |
|
Additional paid-in capital |
|
|
481,958 |
|
|
|
424,050 |
|
Accumulated deficit |
|
|
(454,246 |
) |
|
|
(419,566 |
) |
Total stockholders'
equity |
|
|
27,857 |
|
|
|
4,580 |
|
Total liabilities and
stockholders' equity |
|
$ |
102,743 |
|
|
$ |
99,096 |
|
Biodesix, Inc.Condensed Statements of
Operations (unaudited)(in thousands, except per
share data) |
|
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
Revenues |
|
|
|
|
|
|
|
|
|
|
|
|
Diagnostic Testing revenue |
|
$ |
17,168 |
|
|
$ |
12,301 |
|
|
$ |
47,503 |
|
|
$ |
32,395 |
|
Biopharmaceutical Services and other revenue |
|
|
983 |
|
|
|
1,190 |
|
|
|
3,391 |
|
|
|
2,024 |
|
Total revenues |
|
|
18,151 |
|
|
|
13,491 |
|
|
|
50,894 |
|
|
|
34,419 |
|
Direct costs and expenses |
|
|
4,179 |
|
|
|
3,229 |
|
|
|
11,231 |
|
|
|
9,636 |
|
Research and development |
|
|
2,547 |
|
|
|
1,938 |
|
|
|
7,145 |
|
|
|
8,099 |
|
Sales, marketing, general and administrative |
|
|
20,016 |
|
|
|
15,496 |
|
|
|
60,232 |
|
|
|
51,136 |
|
Impairment loss on intangible assets |
|
|
— |
|
|
|
— |
|
|
|
135 |
|
|
|
20 |
|
Total operating expenses |
|
|
26,742 |
|
|
|
20,663 |
|
|
|
78,743 |
|
|
|
68,891 |
|
Loss from operations |
|
|
(8,591 |
) |
|
|
(7,172 |
) |
|
|
(27,849 |
) |
|
|
(34,472 |
) |
Other (expense) income: |
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense |
|
|
(2,041 |
) |
|
|
(2,386 |
) |
|
|
(6,506 |
) |
|
|
(7,207 |
) |
Loss on extinguishment of liabilities |
|
|
— |
|
|
|
— |
|
|
|
(248 |
) |
|
|
— |
|
Change in fair value of warrant liability, net |
|
|
— |
|
|
|
(1,393 |
) |
|
|
— |
|
|
|
(1,332 |
) |
Other (expense) income, net |
|
|
374 |
|
|
|
2 |
|
|
|
(77 |
) |
|
|
4 |
|
Total other expense |
|
|
(1,667 |
) |
|
|
(3,777 |
) |
|
|
(6,831 |
) |
|
|
(8,535 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(10,258 |
) |
|
$ |
(10,949 |
) |
|
$ |
(34,680 |
) |
|
$ |
(43,007 |
) |
Net loss per share, basic and
diluted |
|
$ |
(0.07 |
) |
|
$ |
(0.14 |
) |
|
$ |
(0.28 |
) |
|
$ |
(0.55 |
) |
Weighted-average shares
outstanding, basic and diluted |
|
|
146,296 |
|
|
|
79,709 |
|
|
|
123,634 |
|
|
|
78,672 |
|
Biodesix, Inc.Reconciliation of Net Loss
to Adjusted EBITDA (unaudited)(in
thousands) |
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
Net loss |
$ |
(10,258 |
) |
|
$ |
(10,949 |
) |
|
$ |
(34,680 |
) |
|
$ |
(43,007 |
) |
Interest expense |
|
2,041 |
|
|
|
2,386 |
|
|
|
6,506 |
|
|
|
7,207 |
|
Depreciation and amortization |
|
1,492 |
|
|
|
782 |
|
|
|
4,324 |
|
|
|
2,351 |
|
Share-based compensation expense |
|
1,515 |
|
|
|
954 |
|
|
|
5,373 |
|
|
|
4,292 |
|
Loss on extinguishment of liabilities |
|
— |
|
|
|
— |
|
|
|
248 |
|
|
|
— |
|
COVID-19 Revenue |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(13 |
) |
COVID-19 Direct costs and expenses |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
1 |
|
Change in fair value of warrant liability, net |
|
— |
|
|
|
1,393 |
|
|
|
— |
|
|
|
1,332 |
|
Other expense (income), net |
|
(374 |
) |
|
|
(2 |
) |
|
|
77 |
|
|
|
(4 |
) |
Adjusted EBITDA |
$ |
(5,584 |
) |
|
$ |
(5,436 |
) |
|
$ |
(18,152 |
) |
|
$ |
(27,841 |
) |
Biodesix (NASDAQ:BDSX)
過去 株価チャート
から 11 2024 まで 12 2024
Biodesix (NASDAQ:BDSX)
過去 株価チャート
から 12 2023 まで 12 2024