Elite Pharmaceuticals, Inc. (PNK:ELTP) Q3 2024 Earnings Call Transcript

Our goal for the current fiscal year was $40 million, and we modified it to north of $40 million. It is safe to say that we’ll achieve our goal for the current fiscal year, and will surpass it, the following year. As Carter outlined, our income four or five years ago was in the single digits, we made $7 million. Then we jump to the teens and then the 20s and then the 30s, $30 million, $34 million last year. We’re skipping the 40s and we’re jumping straight to the 50s this year, and we will continue to grow the year after and the year after. We are not flattening in sales. We are actually growing, and I see all the signs for us to continue to grow, as if I just have reported to you. Elite, successfully transitioned from a CMO private label model to a national distribution with the Elite Label.

We created an organizational structure to support our new business model and increased production, revenues and profits for all of Elite products, not just Amphetamine IR and ER, which are the stars of the show, but also for the rest of our commercial products. The bariatric products, Phentermine and Phendimetrazine. Our hypertension drug Isradipine. Our antidepressant and nerve pain drug Trimipramine. Our schizophrenia and eustachian drug Loxapine. All of them have increased and have been sold under Elite’s label since April 1st, 2023, and they are all growing. Elite’s transition to direct sales is complete and has been a tremendous success. A major credit goes to Kirko, Doug and their teams. Our partner, Prasco, that has a nonexclusive license for selling Amphetamine ER, launched their product in January.

We shipped inventory to them in December of 2023, but the actual launch just happened last month, January 2024. Our other partner Precision Dose, they have a license for naltrexone and phentermine tablets and capsules. Naltrexone is in short supply and is doing particularly well. Elite maintained a strong cash position during our transition to sales. We have supported working capital needs as well as R&D pipeline costs, while maintaining our cash levels. Regarding the research and development pipeline, Elite has four ANDAs, filed under FDA reviews. And antimetabolite ANDA used to treat arthritis, inflammatory arthritis, a generic dopamine agonist, ANDA for the treatment of Parkinson’s. An ANDA for treatment of pain management, a CNS stimulus ANDA used for attention deficit disorder.

And all of them are under FDA review. Elite continues to provide support to whatever FDA requests they make and they make a lot of requests. And Elite will issue a PR upon approval. Regarding the pain management ANDA generic OxyContin. One of the common outcomes of ANDA filing is a lawsuit by the Brand company. Most generic companies contend with such lawsuits in the standard course of business. Elite too has a complaint filed as a part of the Paragraph IV filing. This is an expected event, and Elite expects to manage this as a normal course of business. Elite has other products in the formulation development stage that has not reached a reportable milestone yet. We will update you on them upon reaching these milestones. Regarding the facility and infrastructure, with our success in moving to direct sales, Elite is expanding our inventory and packaging space to meet the growing demands.

We have taken an additional 34,000 square feet to support expanded packaging inventory and warehouse. We closed the deal and took possession of the facility, literally right across from our manufacturing facility in January. Now the hard work begins. You first need permits for construction, to modify the inside of the facility and separate it into two parts and what have you. We are working with IT and servers and installing cameras and ADV security. We’re working on setting up the Vault and working with the DEA of what else do they need, the form of securities Vault in order for them to come in and approve the facility. We purchased the packaging line. Now we need to deliver it and install it, qualify it, make batches on it, put these patches on stability and file or ask FDA for approval.

Have the FDA come in and inspect the facility. At the end of the day, we’ll have duplicate equipment for manufacturing and packaging. We already have validated and qualified our Niro. So now we can make pellets. We have three times the capacity of making what we used to. We have bought a new encapsulators and a new packaging line. On the packaging line alone, once this packaging line is qualified and operational, we will have two packaging lines and the capacity actually will increase by three to four times because the new packaging line is a lot faster and more modern than the old one, which was really a very good packaging line. In summary, Elite has shown strong growth this quarter and is executing its strategy of commercial, sales and distribution and research and development growth.