NEW YORK (GenomeWeb News) – Molecular diagnostics firm AutoGenomics has filed again for an initial public offering in the US.
In its Form S-1 filed Wednesday with the US Securities and Exchange Commission, the company said that it plans to raise as much as $65 million from the offering. It has not priced its shares or said how many shares it plans to offer.
Leerink Swann, Mizuho Securities, Cantor Fitzgerald, and Stephens are listed as the underwriters in the preliminary prospectus for the IPO.
About $10 million of proceeds from the offering are expected to go toward expansion of the company's sales force, enhancement of its international distributor network, and increased marketing and promotional activity and business development. Another $10 million in 2013 and 2014 would be used to support a premarket approval application with the US Food and Drug Administration for its HPV-HR tests, as well as 510(k) and CE mark studies and submissions for tests associated with women's health and personalized medicine.
AutoGenomics said it anticipates using $3 million for R&D and $3 million to expand manufacturing capacity and efficiency. About $5.7 million would go toward satisfying outstanding accounts payables to advisors and service providers, and an unspecified amount would be used to repay principal and interest associated with the company's outstanding promissory notes.
Any remaining proceeds would be for working capital and general corporate purposes, it said.
Based in Vista, Calif., AutoGenomics develops and markets the Infiniti molecular diagnostic system, which was cleared by the FDA in 2007, as well as a menu of genetic tests. In its preliminary prospectus, it said that its tests "provide reference laboratories, hospitals and specialty clinics with genetic test results in a broad range of market segments, including personalized medicine, women's health, oncology, and infectious disease."
As of June 30, the company offered 50 tests for use on the Infiniti platform with an additional 15 tests in development. In addition to FDA clearance of the Infiniti platform, AutoGenomics has 510(k) clearance for its CYP2C19 assay, its warfarin assay, and thrombophilia assay.
It said in its SEC document that it has submitted 510(k) notification for its uridine diphosphate glucuronosyltransferase isoform 1A1 test for determining the initial dosing of oncology drug irinotecan, and intends to submit 510(k) notification in 2013 for its cystic fibrosis as well as HPV genotyping tests.
The company posted $8 million in revenues in 2011 and a loss of $10 million, it said in its Form S-1. R&D costs for the year totaled $2.8 million, while SG&A costs were $6 million.
Through the first six months of 2012, revenues were up to $8.7 million, compared to $3.5 million a year ago. Revenue for the recently completed six months included $700,000 in sales of the Infiniti analyzers and $8 million from the sale of consumables, including sales to one customer of $3.8 million.
AutoGenomics posted a profit of $459,000 for the six months, compared to a net loss of $5.1 million a year ago.
R&D expenses were down to $1.1 million from $1.3 million a year ago, and SG&A costs totaled $2.5 million, down from $2.8 million a year ago.
As of June 30, it had $309,000 in cash and cash equivalents.
The company said it intends to list on the Nasdaq Global Market under ticker symbol AGMX.