Replies to post #2948 on Halozyme Therapeutics Inc (HALO)

[Skeetz99]

Halo is owed a response in 30 days...not necessarily a final decision. Agree! The good news; if HALO Mgt. can prove the clotting can be managed and is not a direct result of PEG20 solely (more based on the other drug cocktails that are mixed with it).

It should bode well for a faster decision. Time will tell......we shall see what direction the company and trials will go in sooner than later.

[maumar]

Why is Barclays modeling such low estimates? It's supposed to be a $2,9B ($145M in royalties) opportunity and they model $2,7 mn in 2015?! I was very surprised when I saw this. Shouldn't revenues ramp up much more quickly? Any thoughts?


Halozyme Therapeutics Inc.

SC MabThera Receives EU Approval

What’s New? Roche and Halozyme just announced that the subcutaneous (SC)

formulation of MabThera for the treatment of non-Hodgkin Lymphoma has been

approved in Europe. This is a positive for HALO and was largely expected following the

positive opinion and recommendation by the EU Committee for Medicinal Products for

Human Use (CHMP) in January.

SC MabThera significantly reduces administration time: This approval was based on

Phase III data from the SABRINA trial, which demonstrated equivalent efficacy and

safety between the previously-approved IV formulation of MabThera versus SC

MabThera. There were no issues with antibody titers. This SC formulation reduces the

administration time from approximately 2.5 hours with the IV formulation to only 5

minutes.

Royalties expected in a couple quarters: Roche will start launching SC MabThera in

different countries in Europe throughout 2014. We expect pricing for SC MabThera to

be comparable to MabThera (IV formulation) and estimate that HALO will receive a 5%

royalty from Roche. We believe meaningful royalties will take a couple quarters to kick

in as Roche works through pricing and reimbursement negotiations. We are currently

modeling $2.1mn in 2014 and $2.7mn in 2015.