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Lannett Company (NYSE: LCI) announced receipt of a non-compliance notice from the NYSE on March 14, 2022, due to its stock price averaging below $1.00 over a 30-day period. The company has six months to regain compliance and is exploring options, potentially requiring stockholder approval for actions taken. Previously, Lannett was also informed on March 2 that it did not meet market capitalization requirements. Despite these notices, Lannett's stock will continue trading on the NYSE, albeit with a 'BC' designation indicating non-compliance.
Lannett Company (NYSE: LCI) will participate in the 34th Annual ROTH Conference on March 14, 2022, at 12:30 p.m. PT in Laguna Niguel, California. The company plans to discuss its product development portfolio, particularly the status of its ANDA for generic Advair Diskus, which has received a Complete Response Letter (CRL) from the FDA. Lannett intends to request a meeting with the FDA to clarify the issues raised. A webcast of the presentation will be available on their website, with an archive accessible for 90 days.
Lannett Company (NYSE: LCI) received a non-compliance notice from the NYSE due to its average market capitalization and reported stockholders' equity falling below $50 million over a 30-day trading period. The company plans to submit a business plan within 45 days to demonstrate how it will regain compliance within 18 months. While there is no immediate impact on trading, the outcome will depend on adherence to NYSE standards. Founded in 1942, Lannett develops generic pharmaceutical products.
Lannett Company (NYSE: LCI) announced the sale of its liquid drug manufacturing facility in Carmel, NY, and other assets for $10.5 million. The transaction will streamline operations and reduce overhead costs, aiding their restructuring plan. With $9.0 million due at closing, the deal is expected to close soon. The buyer will manufacture certain products for Lannett for up to 18 months post-sale. This move aims to strengthen Lannett's cash position while retaining nearly all existing employees at the Carmel facility.
Lannett Company (NYSE: LCI) reported its fiscal 2022 second quarter results with net sales of $86.5 million, down from $133.9 million year-over-year. Gross profit was $5.7 million, indicating a 7% gross margin. The company posted a net loss of $81.1 million, or $2.01 per share. Guidance for 2022 has been revised down, with expected net sales now between $335 million and $360 million. Lannett is restructuring to achieve $20 million in annual savings and anticipates FDA feedback on its ANDA for generic Advair later this month.
Lannett Company (NYSE: LCI) will announce its fiscal 2022 second quarter financial results on February 3, 2022, after market close. A conference call is scheduled for 4:30 p.m. Eastern Time the same day, where management will discuss performance and answer questions. Interested parties can join by calling 888-771-4371 (U.S.) or 847-585-4405 (international), using passcode 50278391. The call will also be streamed live on www.Lannett.com and available for playback for three months.
Lannett Company (NYSE: LCI) announced that the FDA has completed its safety review of the IND application for its biosimilar insulin glargine, allowing the company to proceed with clinical trials. The pivotal trial is expected to start by March 2022 and conclude by early 2023. CEO Tim Crew stated that successful results could lead to a BLA filing in early 2023 and a product launch by early 2024. The trial will take place in South Africa, utilizing the final formulation for the biosimilar insulin glargine.
Lannett Company has submitted an Investigational New Drug (IND) application to the FDA for a pivotal clinical trial of its biosimilar insulin glargine, co-developed with HEC Group. CEO Tim Crew emphasized this submission as a significant milestone towards offering a more affordable treatment for diabetes. The pivotal trial is expected to start in March 2022, with a potential Biologics License Application (BLA) filing in early 2023 and product launch by early 2024, pending trial success. The trial will also be conducted in South Africa under approved regulatory oversight.
Lannett Company (NYSE: LCI) reported fiscal 2022 Q1 results, revealing net sales of $101.5 million, down from $126.5 million year-over-year. Gross profit fell to $16.5 million (16% margin), compared to $25.7 million (20% margin) previously. The company experienced a net loss of $22.3 million ($0.56 per share). Due to competitive pressures, Lannett revised its fiscal 2022 guidance, projecting net sales between $370 million and $400 million, down from $400 million to $440 million. A restructuring plan aims to save $20 million annually.
Lannett Company (LCI) will announce its fiscal 2022 first quarter financial results on November 3, 2021, post-market. A conference call led by management will take place at 4:30 p.m. ET the same day to discuss performance and engage with stakeholders. Interested parties in the U.S. can join by calling 888-771-4371, while international participants can dial 847-585-4405 with passcode 50246855. The call will also be streamed on their website, www.Lannett.com, and available for playback for three months.
