Why Is Assertio Stock Plunging Today?

Assertio Holdings Inc ASRT shares are down after the company withdrew its 2023 financial outlook to assess the recent news of a generic indomethacin suppository approved by the FDA.

Thursday, Zydus Lifesciences Limited received final approval from the FDA to manufacture and market Indomethacin suppositories, 50mg. 

Zydus' Indomethacin suppositories, 50 mg, is the generic version of the Reference Listed Drug Indocin suppositories. 

For its Indomethacin suppositories, the FDA has granted Zydus a CGT designation. Zydus' Indomethacin suppositories have also been granted 180-day CGT exclusivity to market this product.

The Assertio's product portfolio includes Indocin (indomethacin) Suppositories, Indocin (indomethacin) Oral Suspension.

Assertio reported Q2 sales of $40.99 million, up 13% Y/Y, beating the consensus of $39.58 million.

Increased sales of Indocin and Otrexup, plus the addition of Sympazan, offset the expected decline in Cambia.

The company reported Q2 adjusted EPS of $0.19, beating the consensus of $0.14.

The company closed the acquisition of Spectrum Pharmaceuticals Inc for $248 million.

"The acquisition of Spectrum Pharmaceuticals and its innovative ROLVEDONTM asset is transformative to our company. ROLVEDON continues its exceptional launch trajectory as second-quarter sales increased to $21.0 million from $15.6 million in the first quarter. We intend to maintain their highly effective commercial team to continue expanding on the success of this exciting new asset. We also expect to deploy this team's proven market access and contracting capabilities in support of our other assets, particularly Sympazan, Otrexup, and Sprix", said Dan Peisert, President & CEO of Assertio. 

Price Action: ASRT shares are down 44.9% at $2.95 during the premarket session on the last check Friday.