I suspect it has to do with ramping up production of rHuPH20 to meet demand. The good thing a little time and money usually fixes these kinds of issues.
This is from the annual report:
"We have existing supply agreements with contract manufacturing organizations Avid and Cook to produce bulk rHuPH20. These
manufacturers each produce bulk rHuPH20 under current cGMP for clinical uses.
Avid currently produces bulk rHuPH20 for use in Hylenex recombinant and our other collaboration products and product candidates. In addition to supply obligations, Avid and Cook will also provide support for the chemistry, manufacturing and controls sections for FDA and other regulatory filings.
We rely on their ability to successfully manufacture these batches according to product specifications, and Cook has relatively limited experience manufacturing bulk rHuPH20. In addition, we have been working to scale-up, validate and qualify Cook as a manufacturer of bulk rHuPH20 for use in the product and product candidates under the Roche collaboration. To date, Cook has not been submitted to the European regulatory authorities by Roche as an approved manufacturer for Herceptin SC and MabThera SC."
Also last year as noted in at least one conference call they were building rHuPH20 inventory to meet launch demand and expensing it under R&D.
Here's one more quote from the annual report relating to it.
"We have attempted to mitigate the impact of supply interruption through the establishment of excess bulk rHuPH20 inventory."
Good luck HALO longs
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