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Tuesday, 04/13/2021 11:52:24 AM

Tuesday, April 13, 2021 11:52:24 AM

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Endpoints 13Apr2021 AMRN Article

April 13, 2021 07:45 AM EDTUpdated 07:56 AM People
Amarin CEO John Thero pass­es ba­ton to Eu­rope com­mer­cial chief as M&A hopes con­tin­ue to de­flate
Amber Tong
Senior Editor

Karim Mikhail
As Amarin breaks in­to the Eu­ro­pean mar­ket, John Thero is head­ing out.

Af­ter steer­ing the ship for 7 years, Thero is hand­ing the CEO job to Karim Mikhail, who came on board ear­li­er this year to head the com­mer­cial­iza­tion of Amarin’s fish oil pill in Eu­rope. Mikhail’s ap­point­ment is ef­fec­tive Aug. 1, when Thero will of­fi­cial­ly re­tire and tran­si­tion to an ad­vi­sor role un­til the end of 2021.

Since join­ing Amarin in 2009, Thero has been cred­it­ed for a slate of achieve­ments that gave in­vestors lots to be ex­cit­ed about. Un­der his watch, Vas­cepa — the phar­ma­ceu­ti­cal grade omega-3 fat­ty acid prod­uct first ap­proved in 2012 — was cruised to a pos­i­tive Phase III da­ta read­out de­spite some con­tro­ver­sy, spurring an im­pres­sive re­duc­tion in risk of car­dio­vas­cu­lar events that led to a quick FDA add-on ap­proval.

The one thing he is leav­ing with­out is a multi­bil­lion-dol­lar buy­out — and, with the doors ap­par­ent­ly closed to a patent ex­ten­sion, the hopes are dim­ming by the day.

All of that sig­nals a “tough road ahead,” ac­cord­ing to Jef­feries an­a­lyst Michael Yee, who’s been a big cheer­leader for Thero:

Thus, in­vestors may be dis­ap­point­ed in the tran­si­tion and that it may sig­nal no near term M&A on the ta­ble (which is the clear and pri­ma­ry bull case to the stock). That said – one might ar­gue per­haps a change means new mgmt may po­si­tion AM­RN in a way to be eas­i­er to sell via M&A and/or that this opens the co up to more op­tions, but we don’t think that is like­ly and the most log­i­cal sce­nario is AM­RN will go for­ward with a Q3 EU launch which will take time.

In a state­ment, Amarin praised Mikhail’s cre­den­tials in launch­ing new drugs — topped by a stint as glob­al com­mer­cial leader for Mer­ck’s $4 bil­lion lipid fran­chise. In that role, the com­pa­ny high­light­ed, “he was re­spon­si­ble for re­vers­ing the busi­ness’ de­cline in the US mar­ket and glob­al­ly, ac­cel­er­at­ing rev­enue by an ad­di­tion­al $380 mil­lion through the launch of ATOZET and dri­ving EBIT­DA growth through in­ter­na­tion­al ex­pan­sion.”

Amarin will need it. Yee ex­pects the US sales for Q1 to come in just shy of con­sen­sus, even as its gener­ic com­peti­tors at Hik­ma and Dr. Red­dy’s are hav­ing is­sues with man­u­fac­tur­ing and scal­ing up.

“(It) looks like Amarin should be okay in the near term and main­tain 80-90% share, but un­cer­tain­ty re­mains around even­tu­al dura­bil­i­ty of US sales (i.e., what per­cent tail val­ue is re­tained over 2-5+ years),” he wrote.

Fresh­ly ap­proved as Vazkepa in Eu­rope just days ago, the drug is set for a near-term launch and should score an­oth­er OK in Chi­na lat­er this year, Mikhail added.
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