According to the earning conference call in responding to Vival Divan, ANIP stated that the guidance ANIP issued in January included the Harmony deal.
So our initial guidance, which we issued in January, included Cortrophin at $540 million to $575 million, ILUVIEN at $78 million to $83 million, revenues from the out-licensing agreement, gross margin at 59.3% to 60.3%, and adjusted EBITDA at $275 million to $290 million. Our newly raised '26 guidance retains Cortrophin and ILUVIEN revenue guidance. And so for the guidance increase, it's really driven by high Generics revenues on the back of first quarter and visibility into new product launches for the rest of the year. That's one.
Second is clarity around the milestone achievement of the $10 million, the development milestones that is there in the Harmony agreement. So we have more clarity around when that can be achieved. And I think Steve had spoken that, that will be achieved in the second and third quarter, that $10 million will be achieved across the second and third quarter of this year. And third is just refinement of the royalty revenues expected for this year based on the updated 2026 guidance issued by Harmony.
When considering EPS growth concerns, it looks like ANIP has accelerated its hirings beyond those in the acute gouty arthritis team. Both in the US and Europe.
Personally, I am looking forward to market reaction to Libigel when announced. Hopefully soon.