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PL Developments Receives FDA Approval for Omeprazole OTC ANDA

• PL Developments (PLD) has received FDA approval for its Omeprazole Magnesium Tablet, a generic version of Prilosec® OTC, expanding its consumer healthcare product line. • PLD will manufacture the Omeprazole OTC product at its Miami facility, becoming the only US-based provider of this medication, with commercial shipments expected in early 2025. • The US market for Omeprazole OTC is substantial, with annual retail sales of approximately $550 million, presenting a significant opportunity for PLD. • PLD also completed a corporate debt refinancing, enhancing financial flexibility for future growth and strategic investments.

PL Developments (PLD) has announced FDA approval for its Omeprazole Magnesium Tablet, an over-the-counter (OTC) generic version of Prilosec®. This approval marks a significant milestone for the company, expanding its capabilities in the consumer healthcare market.

FDA Approval for Omeprazole OTC

The FDA's approval allows PLD to manufacture and commercialize Omeprazole OTC, a medication used to treat frequent heartburn. The product, bioequivalent to Prilosec® OTC, will be produced at PLD's facility in Miami, Florida. This makes PLD the sole US-based manufacturer of Omeprazole OTC, ensuring a domestic supply chain for this widely used medication.
Evan Singer, President of PLD, stated, "Receiving FDA approval for Omeprazole OTC is a significant achievement for our organization. This accomplishment not only highlights our team's dedication and expertise in bringing complex products to market, but it also reinforces our role as a comprehensive supply partner for our customers."
The market for Omeprazole OTC in the United States is estimated at $550 million annually. PLD anticipates commencing commercial shipments of Omeprazole to its clients in early 2025, potentially capturing a significant share of the market.

Corporate Debt Refinancing

In addition to the FDA approval, PLD announced the successful completion of its offer to exchange $350 million of its 7.750% Senior Secured Notes due 2025 for $368.55 million in new PIK Toggle Senior Secured Notes due 2029. This financial maneuver aims to improve the company's financial flexibility and support future growth initiatives.
Asaph Naaman, Chief Financial Officer, commented, "The successful consummation of the Exchange Offer is a strong affirmation of PLD's financial health and growth trajectory. This achievement reflects our focus on operational efficiencies, free cash flow generation, and building strong relationships with external stakeholders."
PLD expects to issue an additional $131.45 million in New Notes through a concurrent financing, using the proceeds to repay the remaining Old Notes and cover associated fees and expenses.
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PL Developments (PLD) received FDA approval for its Omeprazole Magnesium Tablet, an OTC product comparable to Prilosec® OTC, manufactured in their Miami facility.
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Reference News

[1]
PL Developments Announces FDA Approval for Omeprazole OTC ANDA and Successful ...
morningstar.com · Oct 29, 2024

PL Developments announces FDA approval for Omeprazole OTC ANDA and successful corporate debt refinancing.

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