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
November 3, 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) |
| --- | --- |
| ☐ | Pre-commencement communication pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| --- | --- |
| ☐ | 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 November 3, 2022, Biodesix, Inc. (the Company) issued a press release announcing the financial and operating results of the Company for the third quarter ended September 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 November 3, 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: November 3, 2022 | BIODESIX, INC. | |
|---|---|---|
| By: | /s/ Robin Harper Cowie | |
| Name: | Robin Harper Cowie | |
| Title: | Chief Financial Officer |
EX-99.1
Exhibit 99.1
Biodesix Announces Third Quarter 2022 Results and Highlights
Third quarter 2022 core Lung Diagnostic revenue of $9.2 million increased 102% over the comparable period in 2021;
U.S. Federal Supply Schedule Contract expands coverage to Veterans Health Administration and Military Health System Medical Centers for its entire Lung Diagnostic portfolio;
Conference Call and Webcast Today at 8:00 a.m. ET
BOULDER, CO, November 3, 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 third quarter ended September 30, 2022 and provided a corporate update.
“Our core lung diagnostic testing momentum through the third quarter resulted in record test volume and revenue. Lung diagnostic revenue grew 102% over the third quarter of 2021 and 26% over the second quarter 2022,” said Scott Hutton, President and CEO. “In addition to a focus on sales growth, we have also accomplished several specific strategic reimbursement goals, including all five of our core lung diagnostic tests now being covered by Medicare and the addition of these tests to the Federal Fee Schedule contract for the U.S. Department of Veteran Affairs. These achievements have us well positioned for strong growth and continued high gross margin contributions as we look to the fourth quarter 2022 and beyond. We also remain committed to being a data-driven company through the expansion of our body of supportive clinical data and were proud to have recently participated in the American College of Chest Physicians (CHEST) annual meeting where we had several key presentations.”
Third Quarter 2022 Financial Results
For the three-month period ended September 30, 2022, as compared to the same period of 2021 (where applicable):
• Total revenue of $11.1 million, an increase of 70%, driven primarily by strong year-over-year growth in core lung diagnostics:
o Core lung diagnostic revenue of $9.2 million, reflected a year-over-year increase of 102% driven primarily by the increased adoption of Nodify Lung nodule management tests (Nodify CDT & Nodify XL2 tests) and the recent GeneStrat NGS commercial launch;
o COVID-19 testing revenue of $1.3 million reflected a year-over-year increase of 154% that was driven primarily by testing volume under a now expired contract with the State of Colorado;
o BioPharma Services revenue of $0.7 million decreased 55% 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;
• Third quarter 2022 gross profit of $7.5 million, or 67% gross margin as compared to 58% gross margin in the comparable prior year period primarily driven by the growth of sales in our higher-margin core lung diagnostics;
• Operating expenses (excluding direct costs and expenses) of $18.1 million, an increase of 7% driven primarily by growth in sales and marketing which support the record growth in core lung diagnostics sales as well as the recent GeneStrat NGS™ commercial launch;
o Includes non-cash stock compensation expense of $1.2 million as compared to $1.4 million;
• Net loss of $13.7 million, an increase of 19%, driven primarily by a gain on extinguishment of $3.1 million in the third quarter 2021 related to the debt forgiveness under the Small Business Administration Loan forgiveness program and higher interest costs of $1.5 million partially offset by a reduction in operating loss of $2.5 million or 19%;
• Cash and cash equivalents of $15.2 million as of September 30, 2022;
o Raised net proceeds of $1.8 million during the quarter through equity offerings;
o Includes payments during the quarter for principal repayment of $2.0 million on the 2021 Term Loan and $2.1 million for scheduled milestone payment to Indi.
2022 Financial Outlook
The Company expects to be at the high end of its previously disclosed total revenue guidance for 2022 of $37.5 million and $39.5 million. Our guidance contemplates minimal COVID-19 and BioPharma Services revenue in the fourth quarter and continued growth within our core lung diagnostic testing.
Conference call and webcast information
Listeners can register for the webcast via this link. Analysts wishing 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 website approximately two hours after the call’s conclusion. Those who plan on participating are advised to join 15 minutes prior to the start time.
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 offers five Medicare-covered 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 average of 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. 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:
Robin Harper Cowie
robin.cowie@biodesix.com
(720) 509-8841
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 | 15,175 | $ | 32,712 | ||
| Accounts receivable, net of allowance for doubtful accounts of 50 and 158 | 4,449 | 3,656 | |||
| Other current assets | 4,494 | 7,245 | |||
| Total current assets | 24,118 | 43,613 | |||
| Non‑current assets | |||||
| Property and equipment, net | 4,259 | 4,179 | |||
| Intangible assets, net | 10,223 | 11,617 | |||
| Operating lease right-of-use assets | 3,475 | — | |||
| Goodwill | 15,031 | 15,031 | |||
| Other long-term assets | 6,092 | 1,657 | |||
| Total non‑current assets | 39,080 | 32,484 | |||
| Total assets | 63,198 | $ | 76,097 | ||
| Liabilities and Stockholders' (Deficit) Equity | |||||
| Current liabilities | |||||
| Accounts payable | 2,100 | $ | 1,662 | ||
| Accrued liabilities | 6,677 | 7,665 | |||
| Deferred revenue | 1,637 | 1,850 | |||
| Current portion of operating lease liabilities | 1,436 | — | |||
| Current portion of contingent consideration | 9,286 | 17,764 | |||
| Current portion of notes payable | 14,334 | 19 | |||
| Other current liabilities | 1,945 | — | |||
| Total current liabilities | 37,415 | 28,960 | |||
| Non‑current liabilities | |||||
| Long‑term notes payable, net of current portion | 4,880 | 9,993 | |||
| Long-term operating lease liabilities | 2,855 | — | |||
| Contingent consideration | 20,891 | 16,028 | |||
| Other long-term liabilities | 60 | 1,389 | |||
| Total non‑current liabilities | 28,686 | 27,410 | |||
| Total liabilities | 66,101 | 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; 41,185,532 (2022) and 30,789,649 (2021) shares issued and outstanding | 41 | 31 | |||
| Additional paid‑in capital | 344,138 | 321,669 | |||
| Accumulated deficit | (347,082 | ) | (301,973 | ) | |
| Total stockholders' (deficit) equity | (2,903 | ) | 19,727 | ||
| Total liabilities and stockholders' (deficit) equity | 63,198 | $ | 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>September 30, | Nine Months Ended<br>September 30, | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2022 | 2021 | 2022 | 2021 | |||||||||
| Revenues | ||||||||||||
| COVID-19 | $ | 1,286 | $ | 506 | $ | 5,224 | $ | 29,802 | ||||
| Lung diagnostic | 9,157 | 4,533 | 21,058 | 13,270 | ||||||||
| Diagnostic testing revenue | 10,443 | 5,039 | 26,282 | 43,072 | ||||||||
| Biopharma services | 664 | 1,492 | 2,323 | 4,210 | ||||||||
| Total revenues | 11,107 | 6,531 | 28,605 | 47,282 | ||||||||
| Direct costs and expenses | 3,633 | 2,722 | 10,848 | 28,025 | ||||||||
| Research and development | 2,970 | 3,293 | 9,537 | 9,937 | ||||||||
| Sales, marketing, general and administrative | 15,114 | 13,607 | 44,836 | 36,959 | ||||||||
| Change in fair value of contingent consideration | — | — | — | 1,622 | ||||||||
| Impairment loss on intangible assets | — | — | 81 | — | ||||||||
| Total operating expenses | 21,717 | 19,622 | 65,302 | 76,543 | ||||||||
| Loss from operations | (10,610 | ) | (13,091 | ) | (36,697 | ) | (29,261 | ) | ||||
| Other (expense) income: | ||||||||||||
| Interest expense | (3,039 | ) | (1,546 | ) | (5,522 | ) | (3,012 | ) | ||||
| (Loss) gain on extinguishment of liabilities, net | (52 | ) | 3,123 | (3,004 | ) | 2,395 | ||||||
| Other income, net | 2 | — | 114 | 1 | ||||||||
| Total other (expense) income | (3,089 | ) | 1,577 | (8,412 | ) | (616 | ) | |||||
| Net loss | $ | (13,699 | ) | $ | (11,514 | ) | $ | (45,109 | ) | $ | (29,877 | ) |
| Net loss per share, basic and diluted | $ | (0.34 | ) | $ | (0.41 | ) | $ | (1.22 | ) | $ | (1.09 | ) |
| Weighted-average shares outstanding, basic and diluted | 40,448 | 28,051 | 36,953 | 27,467 |