Esperion and Daiichi Sankyo went from partners to adversaries last week, after Daiichi revealed that it doesn’t plan on paying Esperion the $440M in milestone payments associated with its bempedoic acid cholesterol drug (aka Nexletol in US, Nilemdo in EU).
Daiichi Sankyo agreed to license bempedoic acid’s European commercialization rights in 2019 for $300M, plus up to $900M in milestone payments. Much of those milestones were tied to bempedoic acid’s expansion to new indications by proving its ability to reduce CV risks including:
- $200M – For achieving 15% to 20% risk reduction in its EU regulatory label
- Or $300M – For >20% relative risk reduction on its EU label
- Plus $140M – For other regulatory achievements, including CV risk reduction on its US label
The milestone dispute stems from Esperion’s recent 14k-patient CLEAR Outcomes trial, which showed that Nexletol reduces statin-intolerant patients’ LDL-C (-20%), risk of MI and revascularization (-23% & -19%), and a composite of CV death and nonfatal CV events (-13%, MACE-4, the primary endpoint).
Those results generated major buzz at ACC, and were celebrated by the folks at Esperion as proof of bempedoic acid’s risk-reducing capabilities. In fact, Esperion plans to use that proof to support new FDA and EU regulatory filings in the coming months.
However, Daiichi Sankyo wasn’t as impressed, arguing that since Nexletol’s 13% MACE-4 reduction was below the companies’ agreed-upon ranges, it’s off the hook for all of those milestone payments.
Esperion of course “strongly disagrees” with that interpretation, countering that its 23% reduction in fatal and non-fatal MI means that Daiichi Sankyo actually owes the highest $300M milestone payment (for >20% risk reduction). And Esperion appears very prepared to take that argument to court.
The results of that case might be crucial for Esperion’s financial situation, after posting a $234M net loss in 2022 on $75.5M in revenue. It will also go a long way towards regaining Wall Street’s confidence, after seeing its stock fall by 61% late last week and by 75% since early March.
When Esperion and Daiichi first partnered in early 2019, they seemed bullish about how the alliance would allow bempedoic acid to achieve its clinical and commercial potential. After four years of unsteady progress and a looming legal battle over the CLEAR results, Esperion’s path forward currently seems anything but clear.