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Lannett Company has received FDA approval to manufacture Numbrino, a topical anesthetic, at its Seymour, Indiana plant. This approval allows for a rapid expansion of liquid drug manufacturing previously done at its Carmel, New York facility, which was sold earlier this year. CEO Tim Crew emphasized the company's commitment to enhancing manufacturing efficiencies and indicated that production support from the Carmel site will now only be needed for less than 10 months, significantly faster than industry norms.
Lannett Company (NYSE: LCI) has sold previously discontinued ANDAs for about $3 million to a private pharmaceutical firm, optimizing its asset utilization. Additionally, a private label agreement allows the other company to distribute certain Lannett generic products, with gross margins expected to exceed company averages. Initial orders were placed last quarter, with options for further procurement by May 31, 2023. A portion of these sales has already been included in Lannett's guidance for fiscal 2023.
Lannett Company (NYSE: LCI) has completed subject dosing in the pivotal trial for its biosimilar insulin glargine, developed in partnership with HEC Group. No serious adverse events have been reported. The company achieved its enrollment goals for statistical endpoints and expects to reveal top-line data later this year. The Biologics License Application (BLA) is anticipated to be filed in Spring 2023, with a potential product launch in the first half of 2024. Current U.S. sales for long-acting insulin glargine are estimated at $10 billion annually.
Lannett Company reported net sales of $74.2 million for Q4 FY2022, a decline from $106.0 million in the previous year. The adjusted gross margin was 14%, recovering from earlier quarters. Cash reserves stood at $88 million as of June 30, 2022. Key pipeline updates include advancements in biosimilar insulin projects with top-line results expected by year-end, and a potential launch of biosimilar insulin glargine in 2024. FY2023 guidance predicts net sales between $275 million and $300 million.
Lannett Company (NYSE: LCI) announced it will release its fiscal 2022 fourth quarter and full year financial results on August 24, 2022, after market close. A conference call will follow at 4:30 p.m. ET for management to discuss performance. Interested parties can join the call by dialing 877-407-9716 for U.S. or Canadian callers, and 201-493-6779 for international callers, or by streaming live on the company's website. A playback will be available for three months.
Lannett Company (NYSE: LCI) announced progress in its pivotal clinical trial for biosimilar insulin glargine, with approximately half of the planned participants having received the first dose and no serious adverse events reported. The study is on schedule, expecting topline results by the end of 2022. If successful, Lannett plans to file a Biologics License Application in early 2023 and potentially launch the product in the first half of 2024, marking a significant opportunity in its pipeline.
Lannett Company (NYSE: LCI) announced its exclusive distribution agreement for Fludarabine Phosphate for injection with Areva Pharmaceuticals. The drug addresses ongoing market shortages and is targeted for release later this year, pending FDA approval. U.S. sales for Fludarabine Phosphate reached approximately $4.9 million in the past year, but the current market value is expected to be higher due to disruptions. The company aims to improve patient access to this oncology medication, solidifying its strategic partnership with Areva.
Lannett Company reported Q3 fiscal 2022 results with net sales of $78.4 million, down from $112.4 million YOY. Gross profit dropped to $3.1 million (4% of net sales) from $26.5 million (24%). The company incurred a net loss of $34.9 million or $0.86 per share. Cash increased to over $106 million after selling its liquid manufacturing plant for $10.5 million. Despite ongoing competitive pressure, Lannett is progressing on its pivotal biosimilar insulin glargine trial, expecting results by year-end, aiming for a 2024 launch.
Lannett Company (NYSE: LCI) will announce its fiscal 2022 third-quarter financial results on May 4, 2022, after market closure. A conference call to discuss the results will occur at 4:30 p.m. Eastern Time on the same day. Interested parties can join by dialing 877-344-8082 in the U.S. or Canada, or 213-992-4618 internationally. The call will also be streamed live on the company's website.
Lannett Company (NYSE: LCI) has initiated a pivotal clinical trial for its biosimilar insulin glargine, a significant step in the company's pipeline. This product aims to provide a more affordable insulin option for U.S. diabetes patients. The first patient has been dosed, with topline results expected later this year. If successful, Lannett plans to file a Biologics License Application (BLA) in early 2023, targeting a potential product launch in the first half of 2024. The pivotal trial follows positive results from a previous study, reinforcing expectations of regulatory approval.
