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
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