PL Developments Announces FDA Approval for Omeprazole OTC ANDA and Successful Corporate Debt Refinancing

MIAMI and WESTBURY, N.Y., Oct. 28, 2024 /PRNewswire/ -- PL Developments (PLD), a leader in the development, manufacturing, packaging, and distribution of consumer healthcare products, today announced two significant milestones: FDA approval for its Omeprazole OTC ANDA and the successful refinancing of its corporate debt.

FDA Approval for Omeprazole OTC

The FDA has granted approval for PLD's Omeprazole Magnesium Tablet, a product comparable to Prilosec^® OTC. The product will be manufactured at PLD's facility in Miami, FL, making PLD the only provider of Omeprazole OTC produced in the United States. This achievement underscores the company's extensive capabilities to develop, manufacture, and commercialize some of the most complex products offered in the US consumer healthcare market.

"Receiving FDA approval for Omeprazole OTC is a significant achievement for our organization," said Evan Singer, President of PLD. "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. Our goal is to offer a wide assortment of consumer healthcare products that meet the highest standards of quality and reliability. We are committed to delivering value and consistency to our partners in an ever-evolving marketplace."

The market for Omeprazole OTC in the United States is robust, with retail sales of approximately $550 million annually. PLD expects to commence commercial shipments of Omeprazole to its clients in early 2025.

Corporate Debt Refinancing

In addition to this product milestone, PLD today announces the successful completion of its offer to exchange (the "Exchange Offer") $350,000,000 aggregate principal amount of its outstanding 7.750% Senior Secured Notes due 2025 (the "Old Notes") for new PIK Toggle Senior Secured Notes due 2029 (the "New Notes") in an aggregate principal amount of $368,550,000.  This strategic move was made possible through improved financial performance and a collaborative effort with key stakeholders. The completion of the Exchange Offer enhances the company's financial flexibility and positions it for continued growth and strategic investments.

In addition, we previously entered into a commitment letter with certain holders of the Old Notes pursuant to which we expect to issue and sell to such holders in a private transaction additional New Notes in an aggregate principal amount of $131,450,000 (the "Concurrent Financing"). The proceeds from the Concurrent Financing will be used to repay the remaining amounts of Old Notes outstanding and to pay certain fees and expenses in connection with the Exchange Offer and the Concurrent Financing.

"The successful consummation of the Exchange Offer is a strong affirmation of PLD's financial health and growth trajectory," said Asaph Naaman, Chief Financial Officer. "This achievement reflects our focus on operational efficiencies, free cash flow generation, and building strong relationships with external stakeholders. We are now well-positioned to capitalize on future opportunities and continue our upward momentum."

The New Notes issued in the Exchange Offer have not been and the New Notes that will be issued in the Concurrent Financing will not be registered under the Securities Act, or any other applicable securities laws. This press release is for informational purposes only and is neither an offer to purchase the Old Notes nor a solicitation of an offer to sell the New Notes.

Any statements made in this press release that are not statements of historical fact, including statements about our beliefs and expectations, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, and should be evaluated as such.

About PLD

Founded in 1988 and headquartered in Westbury, NY, PL Developments is a leading developer, manufacturer, packager, and distributor of consumer healthcare products. PLD operates pharmaceutical manufacturing facilities across the United States, encompassing approximately 2 million square feet of real estate and employing 1,800 people. PLD primarily serves US retailers with store brands and Consumer Packaged Goods (CPG) firms with national brands, offering an assortment of more than 450 unique products across several healthcare categories.

SOURCE PL Developments