By David Scott, expert-trainer of The Pharmaceutical Out-licensing Course
In pharmaceutical licensing, it is crucial to understand the concept of a royalty stack. It refers to the layers of royalties and fees that accumulate when multiple parties are involved in the development, manufacturing, and commercialisation of a pharmaceutical product. Failure to factor in the cost impact of third party inputs can have a huge impact on the viability of projects destined for out-license.
The below image shows an example where several royalties are applicable on a drug, and the likely revenue stream from out-licensing:
In this instance, the developing company in-licenses a murine antibody from a university for a modest royalty, but then finds this binds to a receptor whose activity has been patented by another institution, to whom it has to pay a royalty to avoid infringing their patent. The company then has to pay a subcontractor to humanise the antibody (such work often requires a significant royalty fee) and finally has to pay Zetapharm to have access to their proprietary purification technology. Although each payment is relatively small, the stack of royalties adds up to 7% which might well make the project unattractive if the target for out-licensing the finished product is only 10%.
This problem arising from a significant royalty stack can be resolved by substituting royalty payments to third parties with payments of four different types: