PL Developments Gains FDA Nod for Omeprazole OTC ANDA and Refinances Corporate Debt

PL Developments (PLD), a prominent name in the consumer healthcare sector, has announced two notable achievements: FDA approval for its Omeprazole OTC ANDA and the successful refinancing of its corporate debt.

The FDA has given the green light to PLD's Omeprazole Magnesium Tablet, which is similar to Prilosec® OTC. This product will be produced at PLD's facility in Miami, FL, making the company the sole domestic manufacturer of Omeprazole OTC. This milestone showcases PLD’s ability to develop, produce, and market some of the most intricate products in the US healthcare market.

"Securing FDA approval for Omeprazole OTC is a pivotal moment for our company," stated Evan Singer, President of PLD. "This success reflects our team's dedication and expertise in bringing sophisticated products to market, reinforcing our role as a key supply partner. Our mission is to provide a broad range of high-quality and reliable consumer healthcare products. We aim to deliver consistent value to our partners in a constantly evolving marketplace."

The market for Omeprazole OTC in the United States is substantial, with annual retail sales approximating $550 million. PLD anticipates starting commercial shipments of Omeprazole to its clients in early 2025.

In addition to this product milestone, PLD has announced the successful completion of its offer to exchange $350,000,000 of its outstanding 7.750% Senior Secured Notes due 2025 for new PIK Toggle Senior Secured Notes due 2029, amounting to $368,550,000. This strategic refinancing move was facilitated by improved financial performance and collaboration with key stakeholders. The completion of this exchange offer enhances the company's financial flexibility, positioning it for ongoing growth and strategic investments.

Additionally, PLD has entered into a commitment letter with certain holders of the old notes for the issuance and sale of additional new notes amounting to $131,450,000 in a private transaction. The proceeds from this concurrent financing will be used to repay the remaining amounts of the old notes and cover certain fees and expenses associated with the exchange offer and concurrent financing.

"The successful completion of the exchange offer is a testament to PLD's financial strength and growth trajectory," said Asaph Naaman, Chief Financial Officer. "This achievement underscores our focus on operational efficiencies, free cash flow generation, and building strong relationships with external stakeholders. We are now well-positioned to seize future opportunities and maintain our upward trajectory."

Founded in 1988 and headquartered in Westbury, NY, PL Developments is a leading entity in the development, manufacturing, packaging, and distribution of consumer healthcare products. The company operates pharmaceutical manufacturing facilities across the United States, covering approximately 2 million square feet and employing 1,800 people. PLD primarily serves US retailers with store brands and Consumer Packaged Goods (CPG) firms with national brands, offering over 450 unique products across various healthcare categories.

PLD's recent milestones highlight its robust capabilities and strategic financial maneuvers that ensure its continued growth and leadership in the consumer healthcare market.