Elemental
Long

Repatha will bring major volume and take AMGN to new heights.

NASDAQ:AMGN   AMGEN INC
Repatha ( AMGN             ) and Praluent (Regeneron ( REGN             )/Sinofy ( SNY             )) are two PCSK9 inhibitors, a new class of drugs to treat hypercholesterolemia more effectively than previously possible. This will trigger a HCV-like battle between the two as both have high efficacy. Both have room to share the market, allowing both to make a significant amount of money on these blockbuster drugs.

Unlike the HCV battle where GILD had more than a year of first-to-market status, Praluent will only have a month of such status assuming REGN/SNY can capitalize on that extra time to quickly bring it to the US market faster than AMGN             . However, Repatha is expected to hit the EU market sooner, so it's a fair tradeoff as both will be able to get some good traction.

Additional difference could be in the pricing strategy of Praluent being cheaper due to lower dosing, however Repatha has a slightly higher efficacy (61% vs 56% Praluent) and has noted a possible 50% reduction in cardiovascular disease. If AMGN             is able to prove these claims with a large post-marketing study, Repatha will have a significant advantage due to the added secondary benefit and can easily command a higher price point.

Important Repatha Dates:
June 10 ADCOM
Aug 27 PDUFA

Important Praluent Dates:
June 9 ADCOM
July 24 PDUFA

MM's taking this down to $157 is a bargain given the strength of the company's overall pipeline. At the very least, we should see some action heading into the ADCOM dates and both drugs are expected to easily get positive recommendations. EMA has already given positive recommendations for both drugs in May. EMA approval for Repatha is expected in September, shortly after the FDA approval.
timwest PRO
2 years ago
Excellent coverage. How much risk is there here in this idea? In other words, where do you cut the position if it isn't working?
Reply
Elemental timwest
2 years ago
Put a stop just below $150, but it would it take a significant bearish news event or market pullback to get to that low given the strength of accumulation and multiple bounces in the $154-157 area. I strongly believe that Repatha will get approved with ease. what happens after that is where the caution lies depending on marketing strategy and insurance coverage.
Reply
clifkix5
a year ago
How do you feel about about AMGN after Repatha's approval yesterday?
Reply
Elemental clifkix5
a year ago
Sorry for the delayed reply. My thesis still hasn't changed. The hedge funds and algorithms took advantage of the news, attention, Fed/Greece to swing both stocks all over the place. Day traders with deep pockets made some money, but long term holders like myself will be rewarded soon enough in the coming months. I still believe that anything below $158 is a buy and at some point it breakout.

Check out this article from yesterday. Great in-depth analysis. http://seekingalpha.com/article/3259585-amgen-regeneron-ldl-lowering-drugs-provide-major-upside-potential-to-their-stocks

PS. It wasn't an approval, rather a recommendation. In all likelihood FDA will approve both drugs, but restrict the label initially to statin-resistant patients until the CVOT results come in 2017, possibly more interim results next year. Given preliminary results and the ADCOM discussions, Repatha seems to have the edge to get the expanded label first.
Reply
Ideas Scripts Chart
United States
United Kingdom
India
España
Italia
Brasil
Россия
Türkiye
日本
한국
Home Stock Screener Economic Calendar How It Works Chart Features House Rules Moderators For the WEB Widgets Stock Charting Library Priority Support Feature Request Blog & News FAQ Help & Wiki Twitter
Private Messages Chat Ideas Published Followers Following Priority Support Public Profile Profile Settings Billing Sign Out