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

Nasrat Hakim: Thank you, Carter. Carter covered the financials very thoroughly. So I’ll only say a couple of high-level words about financials before I talk about the sales and distribution, the commercial product facility, R&D and then we’ll go to Q&A. Our revenues are growing. Our investment in R&D and the R&D pipeline is growing. Our fundamentals are strong and more stable than ever and we are getting closer to NASDAQ merger or acquisition. Last year was our best year in revenues ever. We generated $34 million. That was when multiple companies were selling Elite’s products, including Lannett. The sales and distribution agreement between Elite and Lannett was terminated two quarters ago. In the last two quarters, we generated $23 million in revenues.

This is at the time where most experts thought we were going to have a major dip by switching between companies because the DEA did not give us enough quota to launch both. We had to finish one to start the other and still we came up with $23 million in revenues. We are on target to achieve another record-breaking year in revenues, definitely north of $40 million. And today, we command a larger market share of the Amphetamine IR and ER market than Lannett. That is a serious noteworthy achievement. With the implementation of Prasco agreement as of January 1, 2024, and the R&D needle mover products expected to be approved in 2024, it is my expectation that this trend will continue in calendar year 2024 and 2025 and beyond. Our business model is looking great for 2024 and 2025.

If you look at just 2023, January through December, that alone will be way north of $45 million. The next two years are going to be a lot better than that. The products that are currently bringing in the revenues are the mixed Amphetamine IR and ER, these were Elite’s largest products last year and we expect them to continue to be our largest product this year under Elite label. We have contracts in place, and we expect to maintain our double-digit market share. Managing the DEA quota has been a challenge. However, Elite has been able to manage through this challenge very well to date. Amphetamine IR remains on the FDA shortage list and both products are in demand. The rest of our commercial portfolio contains the bariatric products, Phentermine and Phendimetrazine weight loss products, Isradipine, a hypertension product, Trimipramine, antidepressant and nerve pain product, Loxapine is for schizophrenia and agitation and Dantrolene as a muscle relaxant.

All are being sold under Elite’s label as of April 1, 2023. And frankly, Prasco is doing a better job at selling our product than any of our partners has ever done. We have also two products that are not being sold at this time, an antibiotic, Doxycycline and in pain management, [indiscernible]. We do not have any plans to sell these products in the near future. One, because we have a partnership with Praxgen and Doxycycline and we haven’t resolved the issues with Doxycycline. And two, [indiscernible] opioid and there are a lot of problems associated with that at this time. With opioid, not the product. As far as the manufacturing, packaging, holding and testing facility is concerned, and increase in sales and distribution requires more testing, more employees and more storage space and more equipment.

So we have upgraded and purchased several pieces of equipment to keep up with the sales demands and also to have backup units. As I have discussed with you before, the capacity and size of our facility have been on my mind for a while now. Even though we can supply our customers’ demands today by running the facility every day on shift and a half or five days a week. We don’t have the space to store the finished product, because most of it is a controlled substance. So let me explain that. When you buy the API and IPI, the active pharmaceutical ingredients and the inactive pharmaceutical ingredients, they come in buckets, and you mix them and blend them, and you make your tablets and capsules. And then you put them in bottles, and you package them.

The bottling and packaging takes massive amount of space compared to the raw materials and the tablets and capsules in the bottle. Now because these are controlled substances, you have to put them in vaults. So the more you make, the more vault space you need, and that is becoming an issue. Before we were making them and shipping them to Lannett and others, now it’s our distribution, it’s our facility, and we need to resolve that problem very soon. So we have been exploring options for manufacturing and storage capacity as I’ve updated you on before. One option is to rent or buy a warehouse that we can retrofit into a manufacturing facility. There’ll be a duplicate of the current facility where you have equipment and personnel and packaging lines and blending and leverages and what have you.