BDSX

BIODESIX INC

NASDAQ · HEALTH CARE · SERVICES-MEDICAL LABORATORIES

21.18

−2.76 −11.53%

USD · close Oct 23

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MKT CAP $223.5MP/E —DIV YIELD —FCF YIELD -9.06%REV TTM $102.9M +34.5%NET INCOME −$27.8MNET DEBT $20M52W 5.46 – 30.60SEC XBRL · TTM TO Invalid Date

How BDSX rewrote its risk factors

10-K ITEM 1A · FY2024 → FY2025

Text kept

63%

of sentences unchanged

Added

398

new sentences

Dropped

343

sentences removed

Length

+74

words, now 60,894

New in FY2025

We reported net losses of $35.3 million and $42.9 million for the years ended December 31, 2025 and 2024, respectively.
As a result of these losses, as of December 31, 2025, we had an accumulated deficit of approximately $497.8 million.
As of December 31, 2025, we had approximately 334 full and part-time employees.
Enhanced U.S. tariffs, import/export restrictions or other trade barriers may have a negative effect on global economic conditions, financial markets and our business.
There is currently significant uncertainty about the future relationship between the U.S. and various other countries with respect to trade policies, treaties, tariffs and taxes.
Current or future tariffs imposed by the U.S. may negatively impact our business.
During 2025, the U.S. presidential administration has threatened and imposed significant tariffs on imports from various countries, and has indicated that additional tariffs may be imposed in the future.
In response, some of these countries have announced or imposed tariffs on imports from the U.S.
The duration for which enacted tariffs will be in place remain uncertain and protracted trade disputes could lead to economic decline, which could negatively impact our results of operations.
For the years ended December 31, 2025 and 2024, Medicare reimbursed 32% and 39%, respectively, of our total revenue to us.
We are exposed to significant future payments and other obligations associated with our acquisition of Freenome (formerly Oncimmune, U.S.A).
If we undergo an ownership change now or in the future, our ability to utilize NOLs and research and development credit carryforwards could be limited by Sections 382 and 383 of the Code.
On November 16, 2022, we entered into a credit agreement and guaranty (the Credit Agreement) with Perceptive Credit Holdings IV, LP as the lender and administrative agent (the Lender) that provides for a senior secured delayed draw term loan facility with Perceptive Advisors LLC (Perceptive), in an aggregate principal amount of up to $50.0 million (the Perceptive Term Loan Facility) to refinance long-term debt.
The Perceptive Term Loan Facility also contains certain covenants limiting our ability to, among other things, engage in certain corporate changes, make certain restricted payments, repay other certain indebtedness or enter into, amend or terminate any other agreements that have the impact of restricting our ability to make loan repayments.
Our ability to comply with these covenants may be affected by factors beyond our control, including changes in our operating performance or liquidity.
A failure to comply with any covenant that is not waived or cured could result in an event of default, which could allow Perceptive to exercise remedies that have a material adverse effect on our business, financial condition, and results of operations.
In addition, the Credit Agreement and the Perceptive Term Loan Facility may limit our ability to obtain additional financing on favorable terms, or at all.
If we incur additional debt in the future, the terms of such indebtedness could include additional covenants or restrictions that further restrict our ability to operate our business.
We may need to raise additional capital to fund our existing operations, develop our platform, commercialize new diagnostic tests or expand our operations.
We may need to raise additional capital in the future to expand our business, to pursue strategic investments, to take advantage of financing opportunities or for other reasons, including to: • increase our sales and marketing efforts to drive market adoption of and address competitive developments; • fund development and marketing efforts of our diagnostic tests or any other future diagnostic tests; • expand our technologies into other types of cancer management and lung disease detection diagnostic tests; • acquire, license, or invest in technologies; • acquire or invest in complementary businesses or assets; and • finance capital expenditures and general and administrative expenses.
Section 216(a) of the PAMA added Section 1834A to the SSA, which established the current CLFS rate setting processes.
Under Section 1834A and its implementing regulations, clinical laboratories that receive the majority of their Medicare revenues from payments made under the CLFS and the Physician Fee Schedule report on a triennial basis (or annually for ADLTs), private payer rates and volumes for their tests with specific billing codes based on final payments made during a set data collection period.
The payment rate for a test for the ensuing three-year period (or one year for ADLTs) is set at the weighted median of the rates reported under the specific billing code for that test.
Newly established codes for CDLTs are priced until the next private payer rate reporting cycle either based on the payment rate of a comparable code on the CLFS, as determined by CMS ("crosswalking") or at the median of rates submitted by the individual MACs based on statutory and regulatory factors ("gapfilling").
New ADLTs are initially priced at “actual list charge” for a nine-month period, after which they are priced based on private payer rates, with a recoupment provision if actual list charge is more than 130% of the weighted median of private payer rates reported.
On January 22, 2026, the House of Representatives passed the “Consolidated Appropriations Act, 2026” which would amend the PAMA law at section 1834A of the Social Security Act.
If enacted, the legislation would require Biodesix, and other laboratories, to report private payer rates paid between January 1 and June 30, 2025 to CMS.
The reporting period would be delayed to May through July, 2026.
The volume-weighted median of the rates reported for each test would set the CLFS rate for certain of our tests in calendar years 2027 to 2029.
If the legislation is not enacted, and the currently scheduled reporting of private payer rates paid between January 1 and June 30, 2019 goes forward, some Biodesix tests may see an increase or decrease in payment rates for 2027-29.
This legislation does not impact reporting of private payer rates or the setting of CLFS rates for Biodesix’s ADLTs, which are repriced annually based on private payer rates.
At the end of 2025, the ACA’s enhanced premium tax credit expired, increasing premium payments for marketplace coverage.
The FDA pays attention to marketing of pharmacogenetic tests.
If Congress were to enact legislation providing the FDA with jurisdiction over LDTs, or if the FDA otherwise issues new rules, policies, or guidance, due to new legislation or on its own accord, or otherwise determines that our tests are not LDTs, our tests may become subject to FDA requirements, including pre-market review.
FDA regulation of laboratory developed tests could have a material adverse effect on the Company’s business.
Historically, the FDA has asserted that it has authority to regulate the development and use of LDTs, such as our and many other laboratories’ tests, as medical devices, although it has generally claimed to exercise enforcement discretion over most tests developed and performed within a single high complexity CLIA-certified laboratory.
FDA attempted to end this policy of enforcement discretion in a May 6, 2024, final rule.
District Court for the Eastern District of Texas struck down the FDA’s final rule, concluding that it exceeds FDA’s statutory jurisdiction, authority, or limitations.
The final rule was vacated and remanded to FDA for further consideration based on the opinion, with the court stating that “[t]here is no likelihood that FDA can justify its decision on remand, given that the final rule exceeds its authority under the FDCA.” The government did not file an appeal to the decision, and in September 2025 FDA rescinded the final rule.
Congress could take action to amend the law to change the current regulatory framework for in vitro diagnostics and LDTs to require premarket FDA review of LDTs and other regulatory requirements.

and 358 more.

Gone since FY2024

We reported net losses of $42.9 million and $52.1 million for the years ended December 31, 2024 and 2023, respectively.
As a result of these losses, as of December 31, 2024, we had an accumulated deficit of approximately $ 462.5 million.
As of December 31, 2024, we had approximately 273 full and part-time employees.
For the years ended December 31, 2024 and 2023, Medicare reimbursed 39% and 43%, respectively, of our total revenue to us.
For the years ended December 31, 2024 and 2023, one customer accounted for 7% and 10%, respectively, of our total revenue.
We are exposed to significant future payments and other obligations associated with our acquisition of Oncimmune, U.S.A., and may not realize the advantages we expect from this acquisition.
We cannot be certain that, following the realization of this acquisition, we will achieve the revenue or specific net income that justifies our entry into it.
We believe that our NOLs are currently not subject to limitation under these rules.
However, if we undergo an ownership change now or in the future, our ability to utilize NOLs and research and development credit carryforwards could be limited by Sections 382 and 383 of the Code.
On November 16, 2022 (Closing Date), we entered into a credit agreement and guaranty (the Credit Agreement) with Perceptive Credit Holdings IV, LP as the lender and administrative agent (the Lender) that provides for a senior secured delayed draw term loan facility with Perceptive Advisors LLC (Perceptive), in an aggregate principal amount of up to $50.0 million (the Perceptive Term Loan Facility) to refinance long-term debt.
The Perceptive Term Loan Facility provides for an “interest-only” period during the term of the loan with principal due at the maturity date, which will be November 21, 2027.
The Perceptive Term Loan Facility may be prepaid at any time, subject to a prepayment premium equal to 2% to 10% of the aggregate outstanding principal amount being prepaid, depending on the date of prepayment.
On May 10, 2023, the Company entered into the First Amendment with the Lender, whereby, subject to the terms and conditions of the First Amendment, the Minimum Net Revenue Covenant (as defined in the Credit Agreement) was amended to reduce the relevant threshold of each fiscal quarter commencing on the fiscal quarter ending June 30, 2023 through and including the fiscal quarter ending March 31, 2024.
As consideration for the First Amendment, the Company agreed to issue to Perceptive a warrant to purchase up to 500,000 shares of the Company’s common stock which are equity classified at a per share exercise price equal to $1.6254.
On August 4, 2023, the Company entered into the Second Amendment to the Credit Agreement and Guaranty (the Second Amendment) with Perceptive as lender and administrative agent and the Company, as borrower, whereby, subject to the terms and conditions of the Second Amendment, the Minimum Net Revenue Covenant (as defined in the Credit Agreement) was amended to reduce the relevant threshold as of the last day of each fiscal quarter commencing with the fiscal quarter ending June 30, 2024 through and including the fiscal quarter ending December 31, 2025.
On February 29, 2024 (the Third Amendment Effective Date), the Company entered into the Third Amendment to the Credit Agreement and Guaranty (the Third Amendment) with Perceptive as lender and administrative agent and the Company, as borrower, whereby subject to the terms and conditions of the Third Amendment, the Minimum Net Revenue Covenant (as defined in the Credit Agreement) was amended to reduce the relevant threshold as of the last day of each fiscal quarter commencing on the fiscal quarter ending March 31, 2024 through and including the fiscal quarter ending December 31, 2025.
On October 30, 2024 (the Fourth Amendment Effective Date), the Company entered into the Fourth Amendment to the Credit Agreement and Guaranty (the Fourth Amendment) with Perceptive, as lender and administrative agent, and the Company, as borrower, whereby subject to the terms and conditions of the Fourth Amendment, the Minimum Net Revenue Covenant (as defined in the Credit Agreement) was amended to reduce the relevant threshold as of the last day of each fiscal quarter commencing on the fiscal quarter ending June 30, 2025 through and including the fiscal quarter ending December 31, 2027.
The Perceptive Term Loan Facility contains certain covenants limiting our ability to, among other things, engage in certain corporate changes, make certain restricted payments, repay other certain indebtedness or enter into, amend or terminate any other agreements that have the impact of restricting our ability to make loan repayments.
We will need to raise additional capital to fund our existing operations, develop our platform, commercialize new diagnostic tests or expand our operations.
We will need to raise additional capital in the future to expand our business, to pursue strategic investments, to take advantage of financing opportunities or for other reasons, including to: • increase our sales and marketing efforts to drive market adoption of and address competitive developments; • fund development and marketing efforts of our diagnostic tests or any other future diagnostic tests; • expand our technologies into other types of cancer management and lung disease detection diagnostic tests; • acquire, license, or invest in technologies; • acquire or invest in complementary businesses or assets; and • finance capital expenditures and general and administrative expenses.
For example, in May 2018 the United States government released a “blueprint,” or plan, to reduce the cost of drugs.
This blueprint contains certain measures that HHS has been working to implement, although it is possible that HHS’s regulatory priorities may change under the Biden administration.
At the state level, legislatures are increasingly passing legislation and implementing regulations designed to control pharmaceutical and biological pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, which are, in some cases, designed to encourage importation from other countries and bulk purchasing.
The Biden administration took steps to strengthen the ACA and focus on reducing the cost of healthcare.
The FDA has recently increased its attention to marketing of pharmacogenetic tests.
If the FDA’s May 6, 2024 Final Rule to end enforcement discretion is implemented or the FDA otherwise issues new rules, policies, or guidance, due to new legislation or on its own accord, or otherwise determines that our tests are not subject to enforcement discretion, our tests may become subject to FDA requirements, including pre-market review.
FDA is phasing out its general policy of enforcement discretion and will regulate laboratory developed tests as medical devices.
Although the FDA has asserted that it has authority to regulate the development and use of LDTs, such as our and many other laboratories’ tests, as medical devices, it has generally exercised enforcement discretion and is currently not otherwise regulating most tests developed and performed within a single high complexity CLIA-certified laboratory.
On September 29, 2023, FDA announced a proposed rule to amend its regulations to explicitly regulate laboratory developed tests (LDTs) as in vitro diagnostic tests in accordance with the agency’s regulatory authority over medical devices.
The FDA finalized its rule on May 6, 2024 and announced that the agency will phase-out its LDT enforcement discretion policy in gradual stages over a total period of four years.
LDTs that fall within targeted enforcement discretion policies may be exempt from some of these requirements.
Under the final rule, our tests that are currently offered as LDTs could become subject to certain statutory and regulatory provisions that are applicable to medical devices, including but not limited to, medical device reporting and correction and removal reporting requirements, quality systems regulations, registration and listing requirements, and premarket review requirements.
Laboratories offering "high-risk" tests that will be subject to premarket authorization application requirements or licensure under Section 351 of the Public Health Service Act, will need to ensure that the appropriate submission is received by the FDA before November 6, 2027.
Laboratories offering “moderate-risk” or “low-risk” tests that will be subject to De Novo authorization or premarket notification submissions will need to ensure that the appropriate submission is received by the FDA before May 6, 2028.
Other regulatory requirements will be gradually phased in beginning on May 6, 2025.
Failure to comply with applicable requirements under the relevant timeframes could cause us to lose the ability to perform our tests, experience disruptions to our business, or become subject to administrative or judicial enforcement actions, which in turn may have an adverse impact on our business, financial condition, and results of operations.
Legal challenges have been filed in federal district court over the agency’s authority to regulate LDTs as medical devices, and the outcome of such litigation and its impact on FDA’s plan to implement the requirements are uncertain.
Congress has also considered legislation to establish a new comprehensive regulatory framework that would provide oversight over LDTs.
Even if the obligations that could be imposed by the final rule do not become applicable to our tests, Congress could take action to amend the law to change the current regulatory framework for in vitro diagnostics and LDTs to require premarket review of LDTs and other regulatory requirements.
Moreover, failure to comply with applicable requirements under the relevant timeframes could cause us to lose the ability to perform our tests, experience disruptions to our business, or become subject to administrative or judicial enforcement actions, which in turn may have an adverse impact on our business, financial condition, and results of operations.

and 303 more.

Sentence-level comparison of Item 1A in the two most recent 10-Ks (FY2024 ↗, FY2025 ↗). A reworded sentence counts as one dropped and one added, so heavy edits read as low “kept”. Headings and page furniture are stripped; nothing is summarised by a model.

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