Given decelerating growth and sooner rather than later, biosimilar competition for brand competitor Lucentis, plus probably other VEGF agents entering the market, I’m going to assume that peak sales are reached soon. My assumption is for $5 B in Eylea revenues, consisting of $3.8-4.0 B in US revenues and $1.0-1.2 B in royalties from BAYRY. The next variable is how long the gravy train lasts before biosimilar competition to Eylea comes in, after which I assume that sales drop to zero (to be conservative). Eylea reached the US market in November 2011. Under current law as provided in the PPACA (Obamacare) legislation, there can be no biosimilar marketed until November 2023. In addition, regulations allow patent term extensions to a maximum of 14 years. Finally, to make matters more obscure, biologic products do not have their patents listed with the FDA as small molecule drugs (NDAs) do, so exactly what patents REGN has that it says protect Eylea are not easy to discern. Generally, though, I’m seeing products get their 14 years, so I’ll assume 2025 as a US and global expiration date for Eylea sales. By doing so, as Eylea sales will not go to zero just because one or more biosimilars are launched, I’m able to make the following assumptions: The arithmetic I’m using for now involves $5 B in sales for 9 years, from 2017-2025. That’s $45 B, about 20% or so is pure pre-tax income with no associated costs. The rest has immense profit margins with small marketing costs relative to revenues.
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