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Exagen Inc. Secures Conditional NY State Approval for New Lupus and Rheumatoid Arthritis Biomarkers and Announces Select Preliminary 2024 Financial Results

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Exagen Inc.
Exagen Inc.

New biomarkers on track for commercial launch in January 2025

Preliminary financial results indicate record full-year revenue and AVISE CTD trailing twelve-month ASP, with improvements to adjusted EBITDA and cash burn

CARLSBAD, Calif., Jan. 12, 2025 (GLOBE NEWSWIRE) -- Exagen Inc. (Nasdaq: XGN), a leading provider of autoimmune testing, today announced it has received conditional approval from the New York State Department of Health for its new systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA) biomarker assays, with a planned commercial launch in January 2025.  The company also announced preliminary unaudited select financial results for the fourth quarter and full year ended December 31, 2024, in line with prior financial guidance.

New AVISE CTD Biomarkers

The company’s new SLE and RA biomarkers will be incorporated into the AVISE CTD platform. Collectively, the company expects these new biomarkers will further improve the clinical utility of AVISE CTD, and provide clinicians with the information they need to definitively diagnose patients and shorten their autoimmune diagnostic journeys.

The new biomarkers are as follows:

  • T-Cell Lupus profile comprises new biomarkers; TC4d, TIgG, and TIgM. These markers provide superior sensitivity for SLE compared to conventional SLE biomarkers, further enhancing our industry-leading AVISE Lupus profile for a more comprehensive diagnosis, particularly in clinically ambiguous cases.

  • RA profile includes additional anti-RA33 biomarkers; IgA, IgG, and IgM. These markers provide clinicians with more data to confidently identify patients with RA and substantiate a seronegative RA diagnosis.

Preliminary Unaudited Select Financial Results

 

 

Three Months Ended
December 31, 2024

 

Twelve Months Ended
December 31, 2024

(in millions, except trailing 12-month average selling price)

 

 

 

 

Revenue

 

$13.3 to $13.8

 

$55.3 to $55.8

Net Loss

 

($3.4) to ($4.4)

 

($14.8) to ($15.8)

Adjusted EBITDA

 

($2.2) to ($3.2)

 

($9.8) to ($10.8)

AVISE CTD Trailing 12-month average selling price

 

$408 to $412

 

$408 to $412

Cash, cash equivalents and restricted cash

 

$22.2

 

$22.2

 

 

 

 

 

The preliminary unaudited select financial results reported today represent:

  • Record full-year 2024 revenue and AVISE CTD ASP

  • AVISE CTD trailing twelve-month ASP improvement of $72 to $76 compared to Q4 2023

  • Full-year 2024 adjusted EBITDA improvement of to 37% to 43% compared to full-year 2023

  • Net neutral cash usage in the fourth quarter of 2024

“2024 was a remarkable year for Exagen by many accounts. We reached a significant milestone by testing our 1,000,000th patient with AVISE CTD, an impressive achievement for any proprietary test, but especially one in a field that hasn’t seen robust biomarker innovation for many decades,” said John Aballi, CEO. “We’ve also made great strides in optimizing our company’s operations and continued our progress toward profitability - a goal which is now firmly within reach, all while delivering record reimbursement per test and record overall revenue performance."