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Lannett Company, Inc. (LCI) announced on April 20, 2023, that the New York Stock Exchange (NYSE) will suspend trading of its common stock and initiate delisting proceedings due to the company's failure to maintain an average global market capitalization of at least $15 million over a 30-day period. Trading will shift to the over-the-counter market starting April 20, 2023, while retaining the ticker symbol LCI. The NYSE will apply to the SEC for delisting, and Lannett does not plan to appeal the decision. The company is engaged in negotiations with key secured creditors for a potential deleveraging transaction, expecting to reach an agreement in the near term, although no assurances can be given regarding the timing or terms of such transactions.
Lannett Company, Inc. (NYSE: LCI) announced positive results from a pivotal clinical trial demonstrating biosimilarity for its insulin glargine to Lantus. The trial met all primary and secondary endpoints without serious adverse events. Additionally, the company is in talks with secured creditors to explore restructuring options due to ongoing competitive pressures, and it has deferred interest payments on convertible notes, entering a 30-day grace period. Lannett expects to submit its Biologics License Application to the FDA in the coming months, but cautions that there's no guarantee of approval. The company has approximately $47 million in unrestricted cash as of March 31, 2023.
Lannett Company reported Q2 2023 net sales of $80.9 million, down from $86.5 million YoY, but gross profit increased significantly to $14.3 million, reflecting an 18% gross margin. Adjusted gross margin improved to 19%. The company noted a $19 million tax refund and a cash balance of $56 million. Positive pipeline developments include anticipated results for insulin glargine and aspart products, with a full-year sales guidance increase to $285-$305 million. Restructuring plans aim to cut costs by $11 million annually, impacting staffing and facilities.
Lannett Company (NYSE: LCI) announced a 1-for-4 reverse stock split effective at 5 p.m. ET on February 6, 2023. Each four shares of common stock will convert into one share. This decision was approved by stockholders during the Annual Meeting on January 25, 2023. After the split, Lannett's common stock will continue trading under the symbol LCI and will be adjusted under a new CUSIP number. Fractional shares will not be issued; instead, stockholders will receive cash payments for them. More details can be found in the definitive proxy statement filed on November 29, 2022.
Lannett Company (NYSE: LCI) announced it will report its fiscal 2023 second-quarter financial results on February 1, 2023, after market close. Management will host a conference call at 4:30 p.m. ET that same day to discuss performance. Interested parties can participate by calling 877-407-9716 in the U.S. or 201-493-6779 internationally, or by accessing the broadcast online at www.Lannett.com. A replay will be available for at least three months. Founded in 1942, Lannett develops and distributes generic pharmaceuticals for diverse medical applications.
Lannett Company (NYSE: LCI) reported positive results from its animal study comparing its biosimilar insulin aspart to US NovoLog®. The study showed high comparability, supporting the upcoming FDA submission for a Biosimilar Biological Product Development meeting in 2023. CEO Tim Crew announced plans for an Investigational New Drug application this summer, with pivotal trials expected to start in Fall 2023, aiming for a Biologics License Application by late 2024 and a potential product launch in 2025. The pivotal trial for biosimilar insulin glargine is slightly delayed, with top-line data expected by February 2023.
Lannett Company (NYSE: LCI) has announced a significant agreement with Ypsomed AG concerning its biosimilar insulin development programs. This agreement entails a patent sublicense for a pen injector device, enhancing Lannett's ability to market biosimilar insulin products in the U.S. and other territories. Clinical trials for biosimilar insulin glargine have reported no serious adverse events, with top-line data expected by year-end. Lannett plans to submit a Biologics License Application for insulin glargine by Spring 2023, aiming for a potential product launch in early 2024.
Lannett Company reported fiscal Q1 2023 net sales of $75.1 million, a decrease from $101.5 million year-over-year. The gross margin was 17%, with an adjusted gross margin of 18%, both showing improvements from the prior quarter. A net loss of $28 million, or $0.68 per share, was reported. The company is optimistic about its pipeline, expecting significant product launches in 2023, including biosimilars for insulin. Cash reserves stand at $78 million, with a projected $20 million in income tax refunds anticipated shortly.
Lannett Company (NYSE: LCI) is set to report its fiscal 2023 first quarter financial results on November 2, 2022, following the market close. Management will discuss the results during a conference call at 4:30 p.m. ET. Interested parties can participate by calling 855-327-6837 or 631-891-4304, or by streaming via www.Lannett.com. Archived playback will be available for three months on the website.
