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The pace of first-time launches has been accelerating over the past two decades.
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This commercial transformation is a critical inflection point for biopharma companies that lack established functional scale and infrastructure.
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In the U.S., the prevalent commercial model for first-time launchers is to self-commercialize, while in Europe most of these companies out-license their product to a partner.
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Sales performance of first-time launches in the U.S. has been marginal, with median U.S. revenues of $32 million and $92 million in the first 12 and 24 months after FDA approval, respectively.
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Nearly 60% of first-time product launches missed sell-side projections in the first 12 months after launch, underperforming expectations by 60%.
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Only 27% of first-time launchers created shareholder value at both 12 and 24 months after FDA approval, while more than 50% of first-time launchers destroyed value at both time points.
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To create sustainable value, first-time launchers must plan and execute on a set of priorities, including operational readiness to scale a commercial organization, a well-thought-out partnering strategy, sufficient capital formation and skillful handling of investor expectations.