8-K
BIODESIX INC (BDSX)
UNITED STATESSECURITIES AND EXCHANGE COMMISSIONWashington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)of the Securities Exchange Act of 1934
August 4, 2022Date of Report (Date of earliest event reported)
Biodesix, Inc.
(Exact Name of Registrant as Specified in Charter)
| Delaware | 001-39659 | 20-3986492 |
|---|---|---|
| (State or other jurisdiction<br>of incorporation) | (Commission<br>File Number) | (I.R.S. Employer<br>Identification No.) |
| 2970 Wilderness Place, Suite 100<br><br>Boulder, Colorado<br><br>(Address of Principal Executive Office) | 80301<br><br>(Zip Code) | |
| --- | --- |
Registrant’s telephone number, including area code: (303) 417-0500
Not Applicable (Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| ☐ | Written communication pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|---|---|
| ☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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| ☐ | Pre-commencement communication pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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| ☐ | Pre-commencement communication pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
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Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
|---|---|---|
| Common Stock, par value of $0.001 per share | BDSX | The Nasdaq Stock Market LLC |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).
Emerging growth company ☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02. Results of Operations and Financial Condition.
On August 4, 2022, Biodesix, Inc. (the Company) issued a press release announcing the financial and operating results of the Company for the second quarter ended June 30, 2022. A copy of the press release is furnished as Exhibit 99.1 to this report and is incorporated herein by reference.
The information contained in Item 2.02 to this Current Report on Form 8-K and Exhibit 99.1 attached hereto is furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such document or filing.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits:
| No. | Exhibit |
|---|---|
| 99.1 | Press Release issued by Biodesix, Inc. dated August 4, 2022 |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Dated: August 4, 2022 | BIODESIX, INC. | |
|---|---|---|
| By: | /s/ Robin Harper Cowie | |
| Name: | Robin Harper Cowie | |
| Title: | Chief Financial Officer |
EX-99.1
Exhibit 99.1
Biodesix Announces Second Quarter 2022 Results and Highlights
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
BOULDER, CO, August 4, 2022 – 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:
o 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);
o 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;
o 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;
o 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;
o Raised net proceeds of $27.3 million during the quarter through debt and equity offerings;
o 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.
Contacts:
Media:
Bobbi Coffin
bobbi.coffin@biodesix.com
(303) 892-3203
Investors:
Chris Brinzey
chris.brinzey@westwicke.com
(339) 970-2843
Biodesix, Inc.
Condensed Balance Sheets (unaudited)
(in thousands, except share data)
| 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 |
All values are in US Dollars.
Biodesix, Inc.
Condensed Statements of Operations (unaudited)
(in thousands, except per share data)
| Three Months Ended<br>June 30, | Six Months Ended<br>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 |