FDA's Rejection of Sage/Biogen's Zuranolone Boosts Prospects for Axsome's Auvelity, Analyst Says

Axsome Therapeutics Inc AXSM reported Q2 sales of $46.7 million, beating the consensus of $40.19 million. 

The company reported a Q2 EPS loss of $(1.54), missing the consensus of $(1.24).

Sales from Auvelity, a prescription oral medicine used to treat adults with major depressive disorder (MDD), reached $27.6 million, up 76% sequentially. There were no Auvelity sales in the comparable 2022 period as the product was launched in October 2022.

Approximately 53,000 prescriptions were reported for Auvelity in Q2, up 72% sequentially.

Sunosi's revenue was $19.1 million, consisting of $18.4 million in net product sales and $0.7 million in royalty revenue associated with Sunosi sales in out-licensed territories. Sunosi's revenue to Axsome for the comparable period in 2022 was $8.8 million.

Q2 U.S. Sunosi total prescriptions increased by 15% Y/Y and 8% sequentially.

Based on the current operating plan, cash and cash equivalents of $437.1 million is sufficient to fund anticipated operations into cash flow positivity.

William Blair notes FDA rejection for Sage Therapeutics Inc SAGE and Biogen Inc's BIIB zuranolone for MDD.

Analysts Myles Minter, Sarah Schram, and Tiffany Marchell say this bodes well competitively for Auvelity in the early launch as a novel-acting branded antidepressant, following a string of other notable misses outside zuranolone including the ARIA trial of PRAX-114 from Praxis PRAX and RELIANCE III study of Relmada's RLMD of REL-1017.

The analysts see Auvelity as an effective antidepressant therapy with a branded therapy competitive moat currently that should garner increasing traction as commercial coverage continues to come online.

Price Action: AXSM shares are down 2.44% at $71.86 on the last check Monday.