Accelerate Diagnostics (AXDX) Regulatory Matters in Order; BTIG Affirms at 'Buy'
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BTIG affirms Accelerate Diagnostics, Inc. (Nasdaq: AXDX) with a Buy rating and $26 price target following Q2 results issued Monday night.
Analyst Karen Koski noted that regulatory matters appear to be in order. The analyst commented,
AXDX’s July 11th FDA 510(k) submission of the Pheno system and PhenoTest BC kit included 118 assays and an add’l 22 assays are expected to be launched under a Research Use Only mode. Based on AXDX’s multiple yrs of discussions with FDA, our view that the Agency is under significant pressure to approve technologies (like AXDX’s) that can help combat the misuse and overuse of antibiotics, and our expectation that the company only submitted assays with near certainty of receiving approval (as defined by the FDA’s established criteria), we remain confident in a 4Q16 US launch of the Pheno system and ~140 assays. With phase 2 of the trial underway, add’l assays may be added to the panel as early as 1Q17.
Early commercial success encouraging and in line with our bullish thesis. On the call, mgmt highlighted a nearly completed build-out of the company’s commercial team, a robust funnel of potential accounts and the conversion of “more than a few” contracts with “many more” under administrative review by hospitals. Though it is likely that many labs are unable to engage in purchase discussions prior to approval, we feel that the willingness of multiple labs to sign contracts—that enable evaluation of the system and that will convert into purchases if certain endpts are met and FDA approval is granted—bodes well for launch, the analyst noted.
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