ANI Pharmaceuticals (ANIP)

[abh3vt]

Asking some of the experts on this board for any possible issues for ANIP regarding the new CMS guidance relating to IRA drug price controls. Concerns over proposed new language hit HALO this am. Leerink downgrade PT to 47 from 63

"Risinger noted, "We are downgrading HALO from MP to UP and lowering our DCF-derived PT from $63 to $47. We adjusted our discount rate from 8% to 12% and lowered our terminal growth rate from -15% to -25%." The analyst further explained the rationale behind the downgrade, stating, "The catalyst for our downgrades is that CMS issued draft guidance for 2028 IRA drug price controls that creates risk that hyaluronidase combination products may not be protected from IRA price negotiations for 13 years after combo approval."

The Leerink Partners analyst also highlighted that the CMS draft guidance language suggests a reinterpretation of the protection period for combination products, which could lead to earlier-than-expected price controls. This change poses a significant risk to Halozyme’s product portfolio and future revenue projections. However, Risinger clarified that no changes to revenue projections were made at this time, as the final guidance from CMS is expected in the second half of 2025."