Despite Early Approval Of Omidubicel, Analyst Says Longer-Term Financial Overhang Remains For Gamida Cell

On Monday, Gamida Cell Ltd GMDA received Omidubicel approval two weeks before the PDUFA date of 1 May.
Soon after, Gamida Cell announced an equity offering of 17.5 million shares and accompanying warrants to purchase 17.5 million shares at $1.30 for approximately $22.8 million in gross proceeds.
Needham analyst has reduced the price target to $6 from $8 with a Buy rating to account for dilution and expectation of a more conservative launch trajectory.
Needham writes that the approval is warranted, given robust Phase 3 results and clear unmet needs.
It also says that the approval is a solid testament to Gamida's ability to execute a complex cellular therapeutic, putting any doubts on drug product execution at bay.
Initial pricing was quoted at $338,000, higher than Needham's expectation of ~$200,000 and more in line with typical cellular therapeutics.
The analyst notes that the clear clinical benefits of Omisirge, particularly in patients who cannot find a match, justify the cellular therapeutic price point. But there are also concerns that the high price point may negatively impact adoption and coverage.
It expects the high price may dampen uptake outside of initial unmatched patients and those slated to receive cord blood.
Needham has reduced the expected market penetration and expects a longer ramp in patients receiving a haplo or unrelated match.
Overall, a peak penetration forecast that assumes Omisirige is used in a little under 2,000 patients each year.
With previously announced restructuring, equity raise can support operations at least till year-end 23. However, a longer-term financial overhang remains.
Price Action: GMDA shares are up 1.19% at $1.62 on the last check Thursday.

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Despite Early Approval Of Omidubicel, Analyst Says Longer-Term Financial Overhang Remains For Gamida Cell

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