The story has been updated with comments from the company's CEO during the JP Morgan Healthcare Conference.
NEW YORK – Accelerate Diagnostics said Thursday that its total revenues for the fourth quarter are expected to be about $3.3 million, which would be up 6 percent from $3.1 million in the year-ago period.
The consensus Wall Street revenue estimate for the quarter is $3.9 million.
Also, after the release of the preliminary results, CEO Jack Phillips provided an update on the firm's strategy during the JP Morgan Healthcare Conference.
The Tucson, Arizona-based company noted that it contracted 16 Pheno instruments with new US customers during the quarter and ended 2021 with 81 instruments in its US backlog. Another 14 Pheno instruments are contracted with distributors and new customers in Europe, the Middle East, and Africa.
Additionally, Accelerate added 13 clinically live Pheno instruments in Q4 and ended the year with 313 revenue-generating instruments in the US.
For full-year 2021, the firm estimates total revenues to be $11.8 million, or up 5 percent from $11.2 million in 2020 but short of the consensus Wall Street estimate of $12.3 million.
Accelerate expects net cash to be $47 million for full year 2021.
Accelerate's shares on the Nasdaq were down about 6 percent in early morning trading Thursday to $4.02.
After the release of the preliminary results, Phillips guided to $13 million in revenues for full-year 2022. The estimates are "tempered due to the inability to substantially grow our installed customer base in the COVID environment," he said during his presentation at the JP Morgan Healthcare Conference, adding that nonetheless, new products, a growing sales funnel, and greater access to customers will lead to higher future growth.
Phillips sketched out a three-prong strategy for future growth involving the development and launch of new products.
"First, we will continue to penetrate the market with our integrated Pheno rapid ID-AST solution and then the recently launched sister to that, the AST test kit," he said. "Secondly, we will enter the untapped and sizable market for rapid MALDI with Arc, which is an automated sample prep system, and then we'll launch the Pheno 2.0 system, which is meant to address the entire market for acute bacterial infections beyond just positive blood cultures."
Accelerate had launched the Pheno AST kit in June 2021 as a follow-up product to its US Food and Drug Administration-cleared Pheno ID-AST system. Pheno AST delivers rapid AST results on the current Pheno platform and can incorporate ID results from a molecular or other system a lab has already purchased.
Accelerate expects to launch the Arc sample preparation system for rapid MALDI ID systems during the first quarter of 2022.
More than half of all US microbiology labs have a MALDI system and it is becoming a modality of choice for pathogen identification for many, because the modality has "the most comprehensive library of organisms, is extremely reliable, and is very cost effective to run," Phillips said.
Nonetheless, MALDI has "one major drawback," he said ─ the speed at which a result can be produced from a positive blood culture.
Though it can take up to 24 hours to produce a MALDI ID, the addition of Accelerate's Arc sample prep system would reduce that runtime to about one hour, Phillips said, adding that after adding the sample preparation system, customers can also run Pheno AST "on the back end of MALDI to produce a rapid AST result."
Meanwhile, Accelerate's next generation platform, Pheno 2, is expected to enable customers to run positive blood cultures and all isolates from any sample type on a single platform. The firm will complete final instrument design and begin assay development for the system in 2022. It plans to conduct clinical trials in 2023 and has targeted early 2024 for launch.
Accelerate now estimates that its total addressable market is about $2 billion annually and growing at 6 percent to 8 percent involving approximately 300 million tests per year, JP Morgan analyst Tycho Peterson said in a research note Thursday. The estimate accounts for "the shift to new products that allows the company to engage with a larger portion of the overall ID/AST market," he said.