NEW YORK ─ Lucid Diagnostics on Monday announced preliminary fourth quarter 2021 revenues of $300,000 on sales of its esophageal cancer test and related collection device.
Analysts on average expected fourth quarter revenues of $400,000.
The New York City-based company recorded no revenues in the year-ago period.
The firm, a majority-owned subsidiary of medical technology firm Pavmed, floated its shares on the Nasdaq in October last year.
Lucid said that in Q4, it processed 303 commercial EsoGuard Esophageal DNA tests for the early detection of esophageal precancer and cancer, an approximately 50 percent increase sequentially from the third quarter of 2021 and a nearly 200 percent increase year over year. Test volume growth has continued into this year and includes referrals to Lucid Test Centers and tests performed at gastroenterology and foregut surgeon practices.
The firm said it has completed the first stage of its Lucid Test Center program, advancing from a pilot program in Phoenix launched in the third quarter of 2021 to a regional Southwest and Pacific Northwest program also covering Denver; Salt Lake City; Las Vegas; Seattle; Portland, Oregon; and Boise, Idaho.
The company said that in the fourth quarter it significantly expanded its sales infrastructure and operations, and it noted that its LucidDx Labs subsidiary recently acquired certain licenses and other related assets from ResearchDx, enabling Lucid to operate a new CLIA-certified, CAP-accredited clinical laboratory in Lake Forest, California.
Lucid said ResearchDx has improved its EsoGuard billing and collection process and enables it to submit claims using the effective Medicare payment rate of $1,938, as it awaits a draft local coverage determination from Medicare administrative contractor Palmetto GBA. Private payors have been reimbursing EsoGuard at $1,150 per test.
This month, Pavmed and Lucid entered an intercompany license agreement granting Lucid the rights to commercialize EsoCure which enables the endoscopic treatment of late esophageal precancer, or dysplastic Barrett’s esophagus. Lucid will pay Pavmed a 5 percent royalty on all EsoCure sales up to $100 million per calendar year, and an 8 percent royalty above that threshold.
Further, Pavmed and Lucid have entered an intercompany agreement for the purchase and sale of CapNostics' assets by Lucid from Pavmed. The assets include the EsophaCap non-endoscopic sponge-based esophageal cell collection device.
On Monday, Lucid entered into a purchase agreement with CF Principal Investments, an affiliate of Cantor Fitzgerald, enabling Lucid to sell up to $50 million of its shares to Cantor and raise equity capital on a periodic basis at a price related to its current market price.
Lucid reported a preliminary fourth quarter net loss of $11.3 million, or $.32 per share, compared to a net loss of $2.7 million, or $.19 per share, in Q4 2020. It anticipates an adjusted Q4 net loss of $.22 per share, which would be short of analysts' average estimate for a net loss of $.20 per share.
The company expects its fourth quarter R&D expenses will rise 83 percent year over year to $2.2 million from $1.2 million, while its SG&A expenses are expected to skyrocket more than sevenfold year over year to $3.4 million from $471,000.
For full-year 2021, Lucid reported preliminary revenues of $500,000, which would match the analysts' average estimate. The firm recorded no revenues for 2020.
Lucid expects a 2021 net loss of $28.1 million, or $1.51 per share, compared to a net loss of $8.3 million, or $.59 per share, in 2020. It anticipates an adjusted 2021 net loss of $.96 per share, which would beat analysts' average estimate for a 2021 net loss of $1.37 per share.
The company expects its 2021 R&D expenses will rise 72 percent year over year to $9.3 million from $5.4 million, while its SG&A expenses are expected to increase more than eightfold year over year to $12.8 million from $1.5 million.
As of Dec. 31, 2021, Lucid had cash and cash equivalents of $53.7 million.