JAZZ - Axsome falls despite 2Q beat; FDA action on depression therapy expected in Q3

Commercial-stage biopharma Axsome Therapeutics ( NASDAQ: AXSM ) fell ~8% in the pre-market even after the company exceeded Street forecasts with its Q2 2022 financials on Tuesday as the investors focus on the regulatory path for the company’s depression candidate AXS-05

In June, Axsome ( AXSM ) shares surged after the management announced that the regulator issued proposed labeling regarding the marketing application for AXS-05, which is currently under the FDA priority review.

With its latest earnings update, the company said that the company expects a potential FDA action on the New Drug Application (NDA) in Q3 2022. With its Q1 financials in May, the management projected a decision in Q2 2022.

However, in terms of financials, Axsome ( AXSM ) reported ~$8.8M in revenue, beating the consensus by as much as $2.5M.

Net product sales of sleep disorder therapy Sunosi drove revenue growth adding $8.8M net product sales after the company completed its U.S. acquisition from Jazz Pharma ( JAZZ ) in May. The ex-U.S. transaction is expected to close in 4Q 2022.

Per the terms of the deal, the ex-U.S. transaction was expected to complete within 60 days from the closure of the U.S. deal.

Meanwhile, net loss widened ~28% YoY to $41.4M as SG&A expenses climbed ~91% YoY to $31.2M. Axsome ( AXSM ) reported $73.4M of cash at the end of the quarter, which, along with a remainder of a $300M term loan, would be adequate to fund operations into 2024.

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