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Tag: LCI STOCK PRICE

  • Lannett Company, Inc. (LCI) stock is going down in aftermarket – Here’s why?

    Lannett Company, Inc. (LCI) has seen a decrease of 19.72% in the aftermarket because the company announced fiscal 2022 second-quarter results. However, the last trading session closed at $1.42 with a decrease of 1.39%.

    Fiscal 2022 Second Quarter Results – Revealed by LCI!

    LCI announced fiscal 2022 second-quarter results on 3rd February 2022. The company experienced net sales of $86.5 million with gross profit that came out to be around $5.7 million. Not only this but the adjusted interest expense rose to $12.9 million. The negative adjusted EBITDA totaled $1.0 million. Last but not the least, the net loss reported was $81.1 million as compared to the $171.9 million from fiscal 2021.

    What’s Next?

    Net sales and gross margin were adversely affected during the quarter. It was due to continued and increasingly competitive pricing pressure across the product portfolio. While LCI expects this price environment to endure in the short term, the company is continuing to implement the basic strategy to expand the product pipeline, develop durable insulin and respiratory assets, and minimize costs across the board.

    Thinking forwards, the company has reduced the guidelines to reflect, among other things, a specific product optimal control effort, a postponement in the expected launch of a product line, considerably fewer supply requests expected for the rest of the year, and the competitive landscape for an amount of the oral similar medicines, as well as the aforementioned competitive environment. Lastly, LCI has a strong cash position of over $98 million as of December 31, 2021.

    Review of Investigational New Drug by LCI– What is it?

    LCI announced on 21st January 2022 that they have received the notification from FDA about the completion of the review of the Investigational New Drug (IND) application for biosimilar insulin glargine. The company is on schedule to start dosing individuals later this quarter. If the research is effective, LCI plans to file a Biologics License Application (BLA) in early 2023. Not only this but if everything went smooth, they might start the marketing of their product in early 2024. Moreover, Biosimilar insulin glargine is a vital product in the long-term development pipeline, and the company is excited to provide this critical biosimilar medicine to diabetic patients.

  • Lannett Company, Inc. (LCI) Stock Exhibits Minor Volatility in the Pre-market; Here is why?

    Lannett Company, Inc. (LCI) stock declined in the pre-market after the company announced that the FDA had completed their review for the application submitted earlier. LCI values at $1.52, declining more than 1.94% from the previously closed value. At the end of the last trading session, the stock closed at around $1.55. The stock traded volume in the previous trading session was approximately 456.84K shares.

    Reason for LCI stock gain

    Lannett Company, Inc. (LCI) announced that the FDA had notified them about completing its safety review application. FDA said that Lannett Company, Inc. (LCI) could proceed with the clinical investigation. The company submitted the Investigational New Drug (IND) application for biosimilar insulin glargine. LCI is co-developing the drug by partnering with the HEC Group of companies. The company expects the crucial clinical study to start in March 2022 and end in early 2023.

    Lannett Company (LCI) expects to file the BLA in early 2023 once the study shows positive results. If authorized, they will commercialize the product in early 2024. Lannett Company, Inc. (LCI) is excited to deliver this critically important and more inexpensive biosimilar medicine to the enormous and rising number of patients living with diabetes.

    The clinical study will be conducted in South Africa at the same site as the first human volunteer research. Following FDA approval of the IND, the study has acquired regulatory clearances in both the US and South Africa. The critical trial will use the final and will market the product as Lannett/HEC biosimilar insulin glargine formulation.

    Effect on the stock gain

    The stock value escalated slightly in the pre-market following the news of getting a green signal from the FDA. Investors are taking a considerable interest in its stock because the stock value might surge if the study is successful and the product is commercialized.

    Conclusion

    The FDA has permitted the company to proceed with the next stage of the study. It will be a crucial part of the trials. But the company seems optimistic and is expecting that the results will be successful. It will be a great relief for diabetic patients once it gets approved.

  • Why Lannett Company Inc. (LCI) stock rallied on Wednesday?

    Why Lannett Company Inc. (LCI) stock rallied on Wednesday?

    Lannett Company Inc. (LCI) stock surged 14.76% in the after-hours trading on Wednesday, June 16, 2021, and close the day at $5.52 per share. Earlier in the morning session, LCI shares gained0.63% to close Wednesday’s morning session at $4.81 per share. LCI shares have fallen 37.29% over the last 12 months, and they have moved down 8.21% in the past week. Over the past three months, the stock has lost 26.45%, while over the past six months, it has shed 27.12%.

    Let’s discuss its recent news and developments

    FDA accepted ANDA, Of the Generic Advair Diskus Filing

    On June 1, 2021, the U.S. Food and Drug Administration (FDA) accepted the Abbreviated New Drug Application (ANDA) for Fluticasone Propionate and Salmeterol inhalation powder (100/50 mcg, 250/50 mcg, and 500/50 mcg), which was submitted by Lannett on behalf of its strategic alliance partner, Respirent Pharmaceuticals Co. Ltd. The FDA assigned a Generic Drug User Fee Act of 2017 (GDUFA II) goal date for this priority original ANDA of January 31, 2022.

    Recent financial results announcement

    On May 5, 2021, Lannett Company, Inc reported its financial results for its fiscal 2021 third quarter ended March 31, 2021.

    Q3 2021 financial highlights

    • Lannett Company reported net sales of 4 million for Q3 2021compared with $144.4 million for the third quarter of fiscal 2020.
    • In Q3 2021, gross profit was $26.5 million compared to $41.7 million in Q3 2020.
    • Total operating expenses were $23.6 million in Q3 2021 compared with $43.8 million inQ3 2020.
    • Net loss was $7.1 million, or $0.18per share in Q3 2021, compared with $16.6 million, or $0.43 per share, for the third quarter of fiscal 2020.
    • In Q3 2021, adjusted net income was $1.0 million, or $0.02per diluted share, compared with $11.7 million, or $0.27 per diluted share, for the fiscal 2020 third quarter.
    • Adjusted EBITDA for the fiscal 2021 third quarter was $17.0 million.

    Closing of senior secured Notes & $190 million second lien senior secured loan facility

    On April 22, 2021, Lannett Company, Inc. closed the $350 million aggregate principal amount of 7.750% senior secured notes due 2026 in a private placement to qualified institutional buyers according to Rule 144A under the Securities Act of 1933, as amended (the “Securities Act”) and outside the United States to persons other than U.S. persons in reliance upon Regulation S under the Securities Act.

    The Company also closed on a $190 million second lien senior secured loan facility due 2026 and amended its asset-based revolving credit facility increasing the size to $45 million from $30 million and extending the maturity to 2026 from 2022.

    Conclusion

    Well, as of this writing there is no recent news or development which could be linked with LCI positive performance on Wednesday. We hope that LCI stock will continue its rally on Thursday as well.