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Re: imanjen13 post# 302101

Friday, 10/19/2018 2:23:59 PM

Friday, October 19, 2018 2:23:59 PM

Post# of 400040
We used to do contract manufacturing of Methadone for someone, probably Epic. The contract was due to end, so Nasrat/we proactively applied and received our own approval to market Methadone. Epic decided to independently handle their Methadone.

That brings us to the last product, and I just mentioned, contributing to increase revenues and that’s Methadone. The overall revenues, when you compare them to last year's quarterly revenues, which were zero, therefore the percentage increase was obviously very large. We had some Methadone sales this year. Last year, we had zero. Now this Methadone, that was a product that we contract, manufactured for one customer who owned the ANDA. Few years ago, it was our largest stream of revenue, but orders from this customer decreased as the customer moved production to its own facility.

The contract to manufacture this Methadone product has expired, that’s just the nature of the contract manufacturing business. We however, have proactively addressed the situation by filing our own ANDA last year and that ANDA was approved by the FDA last week. This is Elite’s Methadone, it’s our own product. We own it, we manufacture it, there is no more contract manufacturing. And this product is included in our alliance with Glenmark, so there you will be marketing and distributing in the near future.

Now commercial production of Methadone has commenced, and we expect to launch it back into the market with Glenmark in the short term. We will have manufacturing revenues, we’ll have a margin that is similar to that, which was earned from the old contract manufacturing product and most importantly, we will now be earning and receiving a share of profits earned from Glenmarks in market sales. This is not the case.

This product wasn’t approved by June 30, so it had no effect on the June quarter, that we just announced, but I'm expecting this new product to be a contributor to future revenue increases, so Methadone will be coming back online. It is coming back online, but now it will be our own product which is definitely an improvement over the contract manufacturing situation.

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