Exagen Diagnostics has filed an amended S-1 form with the U.S. Securities and Exchange Commission (SEC) for its initial public offering (IPO). No terms were given in the filing. The company plans to list on the Nasdaq Global Market under the symbol EXDX.
The underwriters for the offering are Leerink Partners, William Blair and Baird.
This commercial-stage diagnostics company is committed to addressing the significant unmet need for the accurate diagnosis and monitoring of patients affected by autoimmune rheumatic diseases (ARD). These chronic diseases can cause lifelong inflammation in the joints, tissues and internal organs, resulting in serious complications, such as irreversible organ damage.
The accurate, timely and differential diagnosis for patients suffering from the approximately 30 ARDs is critical as treatment for each disease can vary, and inappropriate or delayed therapy may expose patients to unnecessary risks or the hazards of uncontrolled disease activity. Physicians face significant difficulties in making a definitive diagnosis of a specific ARD because patients with different diseases often present with a common set of symptoms.
Exagen currently markets five products under its Avise brand to provide an accurate, timely and differential diagnosis and to optimize the treatment of ARDs. The company processed roughly 9,300 patient specimens for its lead diagnostic product line, Avise SLE, in 2013, about 27,900 in 2014 and roughly 37,200 in 2015.
The diagnosis and treatment of ARDs is generally provided by the community rheumatologist, a sub-specialty of internal medicine that includes approximately 3,500 physicians in the United States.
The company detailed in the filing:
We estimate the market potential of our existing products to be over $950 million annually, based on our internal research and analysis utilizing these incidence and prevalence rates, the prescription information of pharmaceuticals for our drug monitoring products and the current Medicare allowable reimbursement rates for our products ($666 for Avise CTD, $25 for each of Avise MTX and Avise HCQ, and $185 for Avise Anti-TNF).
The company plans to use the proceeds from this offering ultimately to support its operations. Exagen will set aside some of the proceeds for selling and marketing, research and development and capital expenditures, and the remainder for working capital and general corporate purposes.
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