Elite Pharmaceuticals, Inc. (PNK:ELTP) Q2 2024 Earnings Call Transcript

So last time we waited and did announce the opioid till about 30 days, 45 days after we filed it because we did not receive the approval from FDA till then. The same thing is going to happen with the second needle mover. As soon as we hear from the FDA in December that it has been accepted for review, we will issue an announcement, right? So what the FDA does when they receive it and accept it for review, then they start the examination and evaluation process of ANDA, prosecution of ANDA. Every time we found something wrong they sent you a letter called [indiscernible] review letter that says, fix this, do more testing here, sent me all documents, this is not eligible. You do that throughout the entire 10 months. So when we file we don’t go into vacuum for 10 months and then tell you guys, hey, we received a response from FDA or not.

We are actually communicating with them on a regular basis, right? So today, we have three ANDAs that have been accepted for review and under prosecution by the FDA. And the fourth one that I will let you know next month that it has been accepted for review so that will make for this year. One of the ANDAs is dopamine agonist. And that ANDA that we submitted, the FDA has been corresponding back and forth with us. During the evaluation of the ANDA, they found that the microbiological lab that did micro testing on the ANDA was not adequate. So they sent us a note. Now while the ANDA has been prosecuted, you cannot go ahead and change things in it. That’s it. You have to wait till the end of the [indiscernible]. So they had to wait until October, which was our PDUFA date, tell us, go ahead and change the lab, we are in the process of doing that, and we will refile probably within two weeks.

The second ANDA, the antimetabolite ANDA, the FDA is very interested in that because that product is on product shortage. So the FDA is working very closely with us to ensure that it does get approved by the PDUFA date, which is February or before. The third ANDA is the one we received the acceptance for, it’s the opioid. We haven’t gotten much response from them yet. It’s only been a couple of months. I expect next month or the month after they start asking questions. And while we’re at the fourth ANDA, which is the largest of them, I am expecting that the PDUFA date will be September of 2024. And we will focus on that and the opioid ended the most because they are the ones that are going to be game changers. These two products are going to be bigger than Amphetamine IR and ER in my opinion, okay?

Other than what we have in the market, which is three and one, the total of four that are pending for FDA, we have one more product that we did a pilot study for, that’s another needle mover. And the pilots certainly give us guidance on what to do. And I expect that we’re going to run the DV study in 2024 and hopefully file that product then. Next after that is the preliminary work, and I’ve made the decision for the company that going forward, we are no longer going to work on small products. And what I mean by that is, like the product I was alluding to earlier, the dopamine agonist, it is a very small product. It takes a lot of effort to work on small products. It takes a lot more effort to work on larger products, but larger products really pay.

In way of an example [indiscernible] we had about 250 products at the Elizabeth facility. Out of the 250, 12 of them were bringing in 80% of the money and the rest were fillers. Well, we are a small company. So going forward, every single product you are going to select is going to be a large billion-dollar product. So the three products we have in development right now are at the early stage. All of them are product that we have selected that fits within our technology, either tablets, capsules, extended release, instant release. And they need to be either going to be off patent soon or have a very good market. And we have three of these products identified that we will be working on for the next generation. And I’ll keep you updated on that.

These three products that are — we’re starting on other than the five I updated you on are all products that are still on patent for a couple of more years, and each and every one of them is a $1 billion market or above. To wrap it up, this is extremely exciting. The company is turning around finally. We are becoming a fully functional pharmaceutical company with having our own sales and distribution. We are executing on our growth plans, filing new ANDAs, obtaining product approvals and expanding our sales and distribution organization and increasing our revenues. With that, I’ll go to Q&A. As always, I know that you’ve submitted questions to Dian, some of them she called out, other she grouped for me to look at and answer. And I did incorporate quite a bit of the answer to my presentation, but I’ll address some of the questions that you sent me, read them out loud and answer when needed.