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jbog

08/15/10 5:24 PM

#101693 RE: DewDiligence #101690

Dew,

In my view, using some of the following public info, I can't see how the reimbursement can be large enough to be of any consequence. I guess the number in question would be Sandoz's stated investment so far.


From the 2003 Momenta Initial Press Release:
Under the terms of the agreement, Sandoz and Momenta will jointly manage product development and commercialization. Momenta will receive a profit share based on product sales if the parties are successful in their commercialization strategy. In addition, Sandoz will pay development and commercialization costs and make certain other payments to Momenta.

From Momenta's recent 10-K filing:
A portion of the development expenses and certain legal expenses, which in the aggregate have exceeded a specified amount, will be offset against profit-sharing amounts, royalties and milestone payments. Sandoz also may offset a portion of any product liability costs and certain other expenses arising from patent litigation against any profit-sharing amounts, royalties and milestone payments.

From Momenta's 2nd qtr Conference Call:
We do have to repay our proportional share development and legal cost incurred during the past six years. This is paid through a deduction from the profit share owed to us, capped at a maximum of 50% reduction in profit share for each quarter until the costs are fully paid back.

Although, we cannot disclose an exact number, our analysis shows that assuming sales and demand continue, we expect to pay that all owed development cost within the first three quarters post launch and possibly sooner. It is too soon to predict whether or how long we will continue to hold sole generic position. So it's premature to provide any revenue guidance at this time.


From the Sandoz/Sanofi Court Proceeding:
"""Moreover, Sandoz has invested between $50 and $70 million in developing its enoxaparin process and working through the FDA review process."""