Amylyx Report

US ALS Approval is a Significant Milestone

Investment Summary

Near term Amylyx valuation is completely driven by US ALS sales. Uncertainty around European approval and confirmatory trial results will keep the stock volatile. However, US sales expectations appear bullish and could provide a valuation range between $3B and $5.5B. 

Pros:

• Best ALS drug with massive revenue beat in Q1, and sizable Q2 revenues

• Highly dedicated patient population and advocacy groups

• Chance to lock in population before competitors

• Potential buy-out candidate

Cons: 

• Clinical data modest and highly debated (2 adcomms)

• EMA refused approval. Canada approval with conditions. 

• Confirmatory trial is ongoing - given patient population differences and modest efficacy the trial could fail.

• Impact in PSP, AD and WS unclear (high likelihood of failure)

• Other pipeline too early 

Near Term Catalysts

• Nov, 2023 - CHMP Final Opinion - I expect a denial, but there’s also a decent probability of reversal 

• Nov, 2023 - Earnings call - Revenue numbers will be important

• Mid 2024 - Confirmatory trial results