Elite Pharmaceuticals Inc (ELTP)

[RizZo]

Elite Pharmaceuticals, Inc. (ELTP) CEO Nasrat Hakim on Q4 2020 Results - Earnings Call Transcript


Since Adderall XR has launched, has the DEA quota issue been worked out or normalized?

Yes, it has. The DEA was kind enough to give us quota through the end of the year. Now that doesn't mean I have product. I need you to understand that quota means they allow me to buy it. Now I have to work with the API supplier whom they all want upfront cash and the product is extremely expensive and by that bring it in-house test it and then make a product from it. Then sent it to Lannett and that's transfer price 30 days later they pay us. So there is a lot of money that is tied up in working capital when you do something like this. The step one which is a very, very good step is to have approval from the government to do it. Step two now you got to have the money to do it and such thing you got to wait till you get money back so the cycle starts over again, okay.

Following the approval of some [Indiscernible] there was discussion about the DEA quota issues that we just addressed that, okay, there's no issue here.

SunGen Elite Adderall AR, what is going on with transferring the end from SunGen's name to Elite, okay. We did that because Mika took over and as SunGen requested that before actually, it was in the works but when Mika took over we told [Duleep] go ahead and do that, okay. Mainly because of the transfer of the product, okay.

The two antibiotics. Can you please provide an update on the co development of antibiotics?

SunGen suppose to have them the name, we're working very closely with them in order to find a resolution to these. They don't invest any more money and they don't even invest money in even trying to launch a product. So we got to come up with something that's a win-win for both parties. We are working on that.

CNS, ANDA, what is the status of SunGen partnership CNS, ANDA with the potential of $1.5 billion market?

As it would require a bio equivalency trial before submitting and we were led to believe this effort was on the front burner. Why the delay? Well, the delay is because SunGen is not putting in any money. So I reached an agreement with SunGen that we will take over this product. We have no further obligation to them. We are going to develop it to a point where we can run a clinical trial. And it will be 100% Elite's product. We are separating ourselves from SunGen. This product will be going forward all they know how will be ours. We are exploring its viability right now and once we get to a point where there is a milestone will notify you of that.

Luxopine, update on Luxopine launch. We just did that.


Since Adderall XR has launched, has the DEA quota issue been worked out or normalized?

Yes, it has. The DEA was kind enough to give us quota through the end of the year. Now that doesn't mean I have product. I need you to understand that quota means they allow me to buy it. Now I have to work with the API supplier whom they all want upfront cash and the product is extremely expensive and by that bring it in-house test it and then make a product from it. Then sent it to Lannett and that's transfer price 30 days later they pay us. So there is a lot of money that is tied up in working capital when you do something like this. The step one which is a very, very good step is to have approval from the government to do it. Step two now you got to have the money to do it and such thing you got to wait till you get money back so the cycle starts over again, okay.

Following the approval of some [Indiscernible] there was discussion about the DEA quota issues that we just addressed that, okay, there's no issue here.

SunGen Elite Adderall AR, what is going on with transferring the end from SunGen's name to Elite, okay. We did that because Mika took over and as SunGen requested that before actually, it was in the works but when Mika took over we told [Duleep] go ahead and do that, okay. Mainly because of the transfer of the product, okay.

The two antibiotics. Can you please provide an update on the co development of antibiotics?

SunGen suppose to have them the name, we're working very closely with them in order to find a resolution to these. They don't invest any more money and they don't even invest money in even trying to launch a product. So we got to come up with something that's a win-win for both parties. We are working on that.

CNS, ANDA, what is the status of SunGen partnership CNS, ANDA with the potential of $1.5 billion market?

As it would require a bio equivalency trial before submitting and we were led to believe this effort was on the front burner. Why the delay? Well, the delay is because SunGen is not putting in any money. So I reached an agreement with SunGen that we will take over this product. We have no further obligation to them. We are going to develop it to a point where we can run a clinical trial. And it will be 100% Elite's product. We are separating ourselves from SunGen. This product will be going forward all they know how will be ours. We are exploring its viability right now and once we get to a point where there is a milestone will notify you of that.

Luxopine, update on Luxopine launch. We just did that.

Since Adderall XR has launched, has the DEA quota issue been worked out or normalized?

Yes, it has. The DEA was kind enough to give us quota through the end of the year. Now that doesn't mean I have product. I need you to understand that quota means they allow me to buy it. Now I have to work with the API supplier whom they all want upfront cash and the product is extremely expensive and by that bring it in-house test it and then make a product from it. Then sent it to Lannett and that's transfer price 30 days later they pay us. So there is a lot of money that is tied up in working capital when you do something like this. The step one which is a very, very good step is to have approval from the government to do it. Step two now you got to have the money to do it and such thing you got to wait till you get money back so the cycle starts over again, okay.

Following the approval of some [Indiscernible] there was discussion about the DEA quota issues that we just addressed that, okay, there's no issue here.

SunGen Elite Adderall AR, what is going on with transferring the end from SunGen's name to Elite, okay. We did that because Mika took over and as SunGen requested that before actually, it was in the works but when Mika took over we told [Duleep] go ahead and do that, okay. Mainly because of the transfer of the product, okay.

The two antibiotics. Can you please provide an update on the co development of antibiotics?

SunGen suppose to have them the name, we're working very closely with them in order to find a resolution to these. They don't invest any more money and they don't even invest money in even trying to launch a product. So we got to come up with something that's a win-win for both parties. We are working on that.

CNS, ANDA, what is the status of SunGen partnership CNS, ANDA with the potential of $1.5 billion market?

As it would require a bio equivalency trial before submitting and we were led to believe this effort was on the front burner. Why the delay? Well, the delay is because SunGen is not putting in any money. So I reached an agreement with SunGen that we will take over this product. We have no further obligation to them. We are going to develop it to a point where we can run a clinical trial. And it will be 100% Elite's product. We are separating ourselves from SunGen. This product will be going forward all they know how will be ours. We are exploring its viability right now and once we get to a point where there is a milestone will notify you of that.

Luxopine, update on Luxopine launch. We just did that.

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