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Lannett Company (NYSE: LCI) has submitted an Abbreviated New Drug Application (ANDA) for Fluticasone propionate and Salmeterol inhalation powder to the FDA, marking a step towards offering a generic version of ADVAIR DISKUS® from GlaxoSmithKline. This submission covers three dosage strengths and could tap into a $3 billion U.S. market. The company has entered a 12-year U.S. distribution agreement with Respirent Pharmaceuticals, which will allow Lannett to share in the net profits post-approval. The ANDA process is expected to be complex, possibly extending beyond one review cycle.
Lannett Company (NYSE: LCI) has received feedback from the FDA regarding its biosimilar insulin glargine development, co-created with HEC Group. The FDA's comments pertain to the pivotal trial protocol and statistical analysis plan submitted by Lannett following a meeting in June 2020. The feedback has been integrated into the trial design, which will include a larger participant group. The company remains on track to submit an Investigational New Drug Application (IND) later this year and aims to launch the product in 2023, contingent on successful FDA approval.
Lannett Company (NYSE: LCI) announced a new co-development agreement for biosimilar insulin aspart with HEC Group. Insulin aspart, a fast-acting insulin, generated over $6.0 billion in U.S. sales in 2020. Together with insulin glargine, the insulin products target a market of approximately $16.0 billion. Lannett will fund the clinical development and share profits with HEC. The CEO stated that the new manufacturing facility can support significant market share, with few competitors able to match their technical capabilities.
Lannett Company (NYSE: LCI) has commenced marketing Chlorpromazine Hydrochloride Tablets in various dosages, following FDA approval of its Abbreviated New Drug Application. The total U.S. sales for this product were approximately $120 million for the 12 months ending November 2020, although actual market values may be lower. CEO Tim Crew stated that these tablets, used for treating psychotic disorders, are expected to enhance the company’s product offerings with margins exceeding the company average.
Lannett Company (NYSE: LCI) reported its fiscal 2021 Q2 results, highlighting net sales of $133.9 million, a slight decrease from $136.1 million year-over-year. The company faced challenges including a $16.6 million inventory write-down and asset impairment charges of $198 million, leading to a net loss of $171.9 million, or $4.36 per share. Revised guidance for fiscal 2021 sees net sales lowered to $480-$500 million from $520-$545 million. Despite immediate challenges, Lannett remains optimistic about long-term growth prospects and has enhanced financial flexibility with a new $30 million credit facility.
Lannett Company (NYSE: LCI) will announce its fiscal 2021 second-quarter financial results on February 3, 2021, after market close. Management will conduct a conference call at 4:30 p.m. Eastern Time on the same day to review performance and answer questions. Interested parties can join the call by dialing 800-447-0521 (U.S.) or 847-413-3238 (international), using passcode 50088413. The call will also be available via live stream on the company's website, with a playback available for three months.
Lannett Company (NYSE: LCI) has secured a $30 million asset-backed revolving credit facility from Wells Fargo Bank, enhancing its financial flexibility. This credit facility replaces an expired revolver following the payoff of the company's Term A Loans. CEO Tim Crew emphasized that the new facility will support investment in growth opportunities and manage short-term working capital fluctuations, especially during new product launches. The company aims to focus on addressing its Term B Loans, which mature in two years.
Lannett Company (NYSE: LCI) announced it has fully paid off the remaining $42 million balance of its Term A Loans using cash on hand. This repayment is projected to reduce annual interest expenses by approximately $3 million and principal payments by $27 million. CEO Tim Crew emphasized that this move strengthens the balance sheet and enhances financial flexibility since the remaining debt lacks financial covenants. The company's commitment to improving its long-term financial health is evident through this strategic decision.
Lannett Company reported fiscal 2021 Q1 net sales of $126 million, slightly down from $127.3 million a year ago, amidst a challenging market due to the pandemic. The gross profit decreased significantly to 20% of net sales. The company implemented a cost reduction plan aimed to save $15 million annually, alongside launching new products including Levothyroxine Sodium Tablets. Lannett is also paying off Term A Loans to reduce annual expenses by $30 million. The firm maintains its full-year guidance while advancing several promising drug candidates.
Lannett Company announced the launch of its authorized generic of Tirosint (Levothyroxine Sodium Capsules USP) on Nov. 3, 2020. The company has signed an exclusive U.S. distribution agreement with IBSA Institut Biochimique SA, providing sales, marketing, and distribution support, earning a profit share for its role. Currently, Lannett is the sole supplier for all 12 marketed dosage strengths. U.S. sales for Levothyroxine Sodium Capsules were about $111 million in the 12 months ending September 2020. Lannett aims to expand its portfolio with this launch.
