Kite Pharma Inc KITE is preparing to launch Axi-Cel, a chimeric antigen receptor T-cell therapy for non-Hodgkin’s lymphoma patients, later this year.
Analysts from the firm met with executives from the Santa Monica-based biopharma company last week, including CEO Arie Belldegrun.
Cowen has an Outperform on Kite Pharma, and the stock remains a top pick at the firm.
A Controlled Launch
Kite is orchestrating a “controlled” launch of Axi-Cel at 20 sites, with the goal of reaching 72 academic medical centers within a year of the therapy’s FDA approval.
“Once a center is activated, Kite will not place restrictions on how many patients it may treat,” Schmidt said.
“Nonetheless, Kite anticipates centers will be somewhat cautious with their initial adoption as they seek assurance that commercial Axi-Cel is performing similarly to the clinical trial experience.”
The biopharma company has a team of medical science liaisons on staff who can move patients, doctors and facilities through the “vein to vein” treatment process for Axi-Cel, according to Cowen.
The drug is being manufactured at Kite’s El Segundo, California facility.
The centers targeted for Axi-Cel’s rollout have experience securing reimbursements for innovative, hospital-administered drugs, Schmidt said.
At a recent investor event, Kite said the University of Chicago “had already met with every insurer in Illinois to begin the process of securing contracts with payors for the administration of Axi-Cel.”
The same process is being replicated at “many” of the target centers for the drug, according to Cowen.
“Given this progress, Kite expects centers to begin prescribing Axi-Cel within days after FDA approval is granted.”
Revenue from Axi-Cel won’t be recognized until Axi-Cel is delivered to patients, meaning that only minimal revenue will be realized within the calendar year, Schmidt said.
The final step in Axi-Cel’s FDA approval process occurs Nov. 29.