Amicus Therapeutics: What To Expect In 2018
Summary
Amicus enters 2018 with a strong commercial, financial, and pipeline position.
Galafold should continue to grow, expand to other territories, and receive approvals in Japan and the U.S.
Pompe program update is the most important catalyst for the company in 2018.
Pipeline expansion is likely in the next year or two, driven by both internal and external efforts.
Amicus remains well-positioned in 2018 and in the long run despite almost tripling in 2017.
۲۰۱۷ was a great year for Amicus Therapeutics (FOLD). The stock rose 189%, driven mainly by positive developments around Galafold and the positive data from the Pompe program. As a reminder, Amicus was my top pick for 2017, and I am very pleased with its performance, but I am still bullish on the stock heading into 2018.
۲۰۱۷ – a quick review
Amicus started the year near 52-week lows. The company announced in late 2016 that the FDA wanted another phase 3 study for Galafold, which effectively delayed the product’s arrival to market by at least three years. I thought back then that the stock was attractive based on Galafold’s ex-U.S. potential alone and that there could be additional upside based on the success of Zorblisa in EB and ATB200/AT2221 in Pompe disease.
As it turned out, Zorblisa failed, but without a material impact on the share price, while the Pompe program delivered very strong results.
The additional, pleasant surprise was the FDA agreeing that Amicus can submit the NDA for Galafold’s accelerated approval without the company needing to conduct another phase 3 trial. And the NDA was submitted in late 2017.
And finally, Galafold has seen solid uptake in major EU countries (mostly Germany), and the expansion into other countries has yet to yield returns in 2018 and beyond. There were more than 310 patients on reimbursed Galafold at the end of 2017 – 300 was the company’s goal at the start of the year. The uptake curve looks pretty good with acceleration in the second half of 2017, which was driven by launches in France, Italy, and the U.K.
