0001274737-24-000045.txt : 20240513 0001274737-24-000045.hdr.sgml : 20240513 20240513080020 ACCESSION NUMBER: 0001274737-24-000045 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 15 CONFORMED PERIOD OF REPORT: 20240513 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20240513 DATE AS OF CHANGE: 20240513 FILER: COMPANY DATA: COMPANY CONFORMED NAME: EXAGEN INC. CENTRAL INDEX KEY: 0001274737 STANDARD INDUSTRIAL CLASSIFICATION: SERVICES-MEDICAL LABORATORIES [8071] ORGANIZATION NAME: 08 Industrial Applications and Services IRS NUMBER: 000000000 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-39049 FILM NUMBER: 24936930 BUSINESS ADDRESS: STREET 1: 1261 LIBERTY WAY CITY: VISTA STATE: CA ZIP: 92081 BUSINESS PHONE: (760) 560-1501 MAIL ADDRESS: STREET 1: 1261 LIBERTY WAY CITY: VISTA STATE: CA ZIP: 92081 FORMER COMPANY: FORMER CONFORMED NAME: EXAGEN DIAGNOSTICS INC DATE OF NAME CHANGE: 20031230 8-K 1 exdx-20240513.htm 8-K exdx-20240513
0001274737FALSE00012747372023-05-152023-05-15

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): May 13, 2024
EXAGEN INC.
(Exact name of registrant as specified in its charter)





Delaware

001-39049

20-0434866
(State or other jurisdiction
of incorporation)

(Commission
File Number)

(IRS Employer
Identification No.)
1261 Liberty Way
Vista, CA 92081
(Address of principal executive offices) (Zip Code)
(760) 560-1501
(Registrant’s telephone number, including area code)
N/A
(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 communications 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 communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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 $0.001 per share

XGN

The Nasdaq Global Market
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter). 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 May 13, 2024, the Company reported its financial results for the three months ended March 31, 2024. A copy of the press release issued by the Company is furnished as Exhibit 99.1 to this report.
The information furnished with Item 2.02 of this report, including Exhibit 99.1, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any other filings under the Exchange Act or under the Securities Act of 1933, as amended, whether made before or after the date hereof, regardless of any general incorporation language in such filing, except as shall be expressly set forth by specific reference in such a filing.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits



Exhibit No.

Description


99.1



104Cover Page Interactive Data File (embedded within the Inline XBRL document)




SIGNATURES
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.











EXAGEN INC.




Date: May 13, 2024



By:

/s/ Kamal Adawi






Kamal Adawi






Chief Financial Officer


EX-99.1 2 q12024exagenearningspressr.htm EX-99.1 Document

image_0.jpg

Exagen Inc. Reports Strong First Quarter 2024 Results:
Raises Guidance for Full Year

May 13, 2024

Carlsbad, Calif., – Exagen Inc. (Nasdaq: XGN), a leading provider of autoimmune testing solutions, today reported financial results for the quarter ended March 31, 2024.

First Quarter Highlights:

Recognized total revenue of $14.4 million in the first quarter of 2024, a 28.4% increase over the first quarter of 2023.
Delivered gross margin of 59.6% in the first quarter of 2024, compared to a gross margin of 47.2% in the first quarter of 2023.

AVISE® CTD trailing twelve-month average selling price (ASP) of $377, a 35.1% increase over the trailing twelve-month ASP in the first quarter of 2023.

Net loss of $3.4 million in the first quarter of 2024, a 56.3% improvement over the first quarter of 2023.

Adjusted EBITDA of $(2.0) million for the first quarter of 2024, a 67.7% improvement over the first quarter of 2023.

Cash and cash equivalents were $27.3 million, with cash runway into 2026.


"I'm thrilled with the strong start to the year, where we saw continued improvements in our key metrics, bringing us closer to our goal of profitability. Our volume increased in every month of the first quarter, and we’re seeing that trend continue into the second quarter. We've built strong momentum with material improvements to our ASP, and I'm excited about the opportunities that lie ahead, including updates to our flagship product, AVISE CTD. The inclusion of T-cell and new RA markers into AVISE CTD will make our industry leading offering even more valuable to clinicians and positively impact the company's financial standing. Given the continued trajectory and strength of our business, we are raising our revenue and adjusted EBITDA expectations for the full year 2024. The Exagen team has done a fantastic job, and I'd like to thank them for their hard work and dedication,” said John Aballi, President and Chief Executive Officer.

First Quarter 2024 Financial Results 
Revenue was $14.4 million in the first quarter of 2024, compared to $11.2 million in the first quarter of 2023, primarily due to improved ASP. Gross margin was 59.6% in the first quarter of 2024, compared to



47.2% in the first quarter of 2023. The increase in gross margin percentage was driven by an increase in ASP.

Operating expenses were $17.4 million in the first quarter of 2024, compared with $18.9 million in the first quarter of 2023. The decrease in operating expenses was a result of lower selling, general and administrative expenses related to a reduced headcount.

Net loss was $3.4 million for the first quarter of 2024, compared to a net loss of $7.7 million in the first quarter of 2023.
Adjusted EBITDA was $(2.0) million for the first quarter of 2024, compared to $(6.2) million for the first quarter of 2023.
Cash and cash equivalents were $27.3 million as of March 31, 2024 and our accounts receivable balance was $10.9 million.

A reconciliation of non-GAAP adjusted EBITDA to GAAP net loss, the closest GAAP financial measure, is provided in the financial schedules that are part of this press release. An explanation of this non-GAAP financial measures is also included below under the heading “Use of Non-GAAP Financial Measures (unaudited).”

2024 Guidance 
For full year 2024 revenue, we are increasing our guidance to at least $55 million and now believe our adjusted EBITDA will be better than negative $18 million. Given our continued improved performance, we believe our existing cash and cash equivalents are adequate to meet our anticipated cash requirements into 2026.


Conference Call
A conference call to review first quarter 2024 financial results and to provide a business update is scheduled for today, May 13, 2024, at 8:30 AM Eastern Time (5:30 AM Pacific Time). Interested parties may access the conference call by dialing (201) 389-0918 (U.S.) or (877) 407-0890 (international). Additionally, a link to a live webcast of the call will be available in the Investor Relations section of Exagen's website at investors.exagen.com.
Participants are asked to join a few minutes prior to the call to register for the event. A replay of the conference call will be available until Monday, May 27, 2024, at 11:59 PM Eastern Time (8:59 PM Pacific Time). Interested parties may access the replay by dialing (201) 612-7415 (U.S.) or (877) 660-6853 (international) using passcode 13746122. A link to the replay of the webcast will also be available in the Investor Relations section of Exagen's website.
Use of Non-GAAP Financial Measures (UNAUDITED)
In this release, we use the metrics of adjusted EBITDA, which is not calculated in accordance with generally accepted accounting principles in the United States (GAAP) and is a non-GAAP financial measure. Adjusted EBITDA excludes from net loss interest income (expense), depreciation and amortization expense, and stock-based compensation expense.

We use adjusted EBITDA internally because we believe these metrics provide useful supplemental information in assessing our operating performance reported in accordance with GAAP. We believe



adjusted EBITDA may enhance an evaluation of our operating performance because it excludes the impact of prior decisions made about capital investment, financing, investing and certain expenses we believe are not indicative of our ongoing performance. However, this non-GAAP financial measure may be different from non-GAAP financial measures used by other companies, even when the same or similarly titled terms are used to identify such measures, limiting their usefulness for comparative purposes.

This non-GAAP financial measure is not meant to be considered in isolation or used as a substitute for net loss reported in accordance with GAAP, should be considered in conjunction with our financial information presented in accordance with GAAP, has no standardized meaning prescribed by GAAP, is unaudited, and is not prepared under any comprehensive set of accounting rules or principles. In addition, from time to time in the future, there may be other items that we may exclude for purposes of these non-GAAP financial measures, and we may in the future cease to exclude items that we have historically excluded for purposes of these non-GAAP financial measures. Likewise, we may determine to modify the nature of adjustments to arrive at these non-GAAP financial measures. Because of the non-standardized definitions of non-GAAP financial measures, the non-GAAP financial measure as used by us in this press release and the accompanying reconciliation table have limits in their usefulness to investors and may be calculated differently from, and therefore may not be directly comparable to, similarly titled measures used by other companies. Accordingly, investors should not place undue reliance on non-GAAP financial measures.

About Exagen
Exagen is a leading provider of autoimmune testing and its purpose as an organization is to provide clarity in autoimmune disease decision making with the goal of improving patients’ clinical outcomes. Exagen is located in San Diego County, California.

For more information, please visit Exagen.com or follow @ExagenInc on X (formally known as Twitter).

Forward Looking Statements
Exagen cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on Exagen’s current beliefs and expectations. Such forward-looking statements include, but are not limited to, statements regarding: Exagen’s goals, strategies and ambitions; potential future financial and business performance; the potential utility and effectiveness of Exagen’s services and testing solutions; updates to be made to AVISE® CTD; potential shareholder value and growth and 2024 guidance. The inclusion of forward-looking statements should not be regarded as a representation by Exagen that any of its plans will be achieved. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in Exagen’s business, including, without limitation: delays in reimbursement and coverage decisions from Medicare and third-party payors and in interactions with regulatory authorities, and delays in ongoing and planned clinical trials involving its tests; changes in laws and regulations related to Exagen’s regulatory requirements; Exagen’s commercial success depends upon attaining and maintaining significant market acceptance of its testing products among rheumatologists, patients, third-party payors and others in the medical community; Exagen’s ability to successfully execute on its business strategies; third-party payors not providing coverage and adequate reimbursement for Exagen’s testing products, including Exagen’s ability to collect on funds due; Exagen’s ability to obtain and maintain intellectual property protection for its testing products; regulatory developments affecting Exagen’s business; and other risks described in Exagen’s prior press releases and Exagen’s filings with the Securities and Exchange Commission (“SEC”), including under the heading “Risk Factors” in Exagen’s



Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on March 18, 2024, its Quarterly Report on Form 10-Q for the quarter ended March 31, 2024, filed with the SEC on May 13, 2024 and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Exagen undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

Contact:
Ryan Douglas
Exagen Inc.
ir@exagen.com
760.560.1525




Exagen Inc.
Unaudited Condensed Statements of Operations
(in thousands, except share and per share data)
 Three Months Ended March 31,
 20242023
 
Revenue$14,415 $11,230 
Operating expenses:
Costs of revenue5,817 5,926 
Selling, general and administrative expenses10,542 11,884 
Research and development expenses1,059 1,126 
Total operating expenses17,418 18,936 
Loss from operations(3,003)(7,706)
Interest expense(549)(638)
Interest income192 656 
Net loss$(3,360)$(7,688)
Net loss per share, basic and diluted$(0.19)$(0.44)
Weighted-average number of shares used to compute net loss per share, basic and diluted17,944,438 17,526,763 





Exagen Inc.
Unaudited Condensed Balance Sheets
(in thousands, except share and per share data)
 March 31, 2024December 31, 2023
 
Assets
Current assets:
Cash and cash equivalents$27,267 $36,493 
Accounts receivable, net10,901 6,551 
Prepaid expenses and other current assets4,232 4,797 
Total current assets42,400 47,841 
Property and equipment, net4,775 5,201 
Operating lease right-of-use assets3,072 3,286 
Other assets561 616 
Total assets$50,808 $56,944 
Liabilities and Stockholders' Equity
Current liabilities:
Accounts payable$1,470 $3,131 
Accrued and other current liabilities6,040 7,531 
Operating lease liabilities1,005 976 
Borrowings-current portion268 264 
Total current liabilities8,783 11,902 
Borrowings-non-current portion, net of discounts and debt issuance costs19,269 19,231 
Non-current operating lease liabilities2,497 2,760 
Other non-current liabilities268 357 
Total liabilities30,817 34,250 
Commitments and contingencies (Note 5)
Stockholders' equity:
Preferred stock, $0.001 par value; 10,000,000 shares authorized, no shares issued or outstanding as of March 31, 2024 and December 31, 2023
— — 
Common stock, $0.001 par value; 200,000,000 shares authorized as of March 31, 2024 and December 31, 2023; 17,317,941 and 17,045,954 shares issued and outstanding as of March 31, 2024 and December 31, 2023, respectively
17 17 
        Additional paid-in capital
302,550 301,893 
Accumulated deficit(282,576)(279,216)
Total stockholders' equity19,991 22,694 
Total liabilities and stockholders' equity$50,808 $56,944 




Exagen Inc.
Reconciliation of Non-GAAP Financial Measures (UNAUDITED)
The table below presents the reconciliation of adjusted EBITDA, which is a non-GAAP financial measure. See "Use of Non-GAAP Financial Measures (UNAUDITED)" above for further information regarding the Company's use of non-GAAP financial measures.
 Three Months Ended March 31,
 20242023
(in thousands)
Adjusted EBITDA
Net loss$(3,360)$(7,688)
Other (Income) Expense(192)(656)
Interest Expense549 638 
Depreciation and amortization expense458 553 
Stock-based compensation expense553 984 
Adjusted EBITDA (Non-GAAP)$(1,992)$(6,169)



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Cover
May 15, 2023
Cover [Abstract]  
Document Type 8-K
Document Period End Date May 13, 2024
Entity Registrant Name EXAGEN INC.
Entity Incorporation, State or Country Code DE
Entity File Number 001-39049
Entity Tax Identification Number 20-0434866
Entity Address, Address Line One 1261 Liberty Way
Entity Address, City or Town Vista
Entity Address, State or Province CA
Entity Address, Postal Zip Code 92081
City Area Code 760
Local Phone Number 560-1501
Written Communications false
Soliciting Material false
Pre-commencement Tender Offer false
Pre-commencement Issuer Tender Offer false
Title of 12(b) Security Common Stock, par value $0.001 per share
Trading Symbol XGN
Security Exchange Name NASDAQ
Entity Emerging Growth Company true
Entity Ex Transition Period false
Entity Central Index Key 0001274737
Amendment Flag false
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