LANNETT SHARES UPDATE
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.
- Successful pivotal clinical trial for biosimilar insulin glargine showing biosimilarity to Lantus.
- All primary and secondary endpoints met in the trial.
- No serious adverse events reported during the trial.
- Plans to file Biologics License Application with the FDA soon.
- Currently deferring interest payment on unsecured convertible notes, entering a 30-day grace period.
- Ongoing competitive pressures affecting the company's portfolio.
- Potential dilution of common stock during recapitalization or restructuring.
Announces Positive Results from Pivotal Clinical Insulin Trial that Demonstrates Biosimilarity to Reference Product
Productive Conversations with Key Secured Creditors Toward a Balance Sheet Strengthening, Recapitalization or Restructuring Transaction Ongoing As Company Enters Grace Period for Failure to Pay Interest on Convertible Notes
Results of Insulin Study
The pivotal clinical trial of biosimilar insulin glargine demonstrated positive results, in line with prior expectations. The Company is co-developing this product with its strategic alliance partners within the
"We are pleased with the results of this crucial clinical trial of biosimilar insulin glargine," said
Lannett is moving forward expeditiously to complete the Biologics License Application, with the goal of submitting the application to the FDA within the next several months. Prior to filing, there are additional meaningful activities to complete, including a device differentiation study, which will run in April, and more comparability work showing HEC's insulin glargine is biosimilar to US sourced Lantus. Lannett also anticipates engaging with the FDA in a pre-submission meeting. There are significant steps necessary for the Company to receive FDA approval to effectively commercialize this product, and there is no guarantee that the Company will be successful in this regard.
The Company continues to assess the potential impacts of recent developments in the insulin market, including announcements by manufacturers related to lowering the price of insulin for patients, especially list prices, and enhancing market transparency. Lannett welcomes these initiatives to help drive greater access to this critical medicine and believes these changes dovetail with the Company's promising go-to-market approach.
Financial Update
As a result of continued competitive pressures on the Company's current portfolio and to evaluate options to establish a sustainable capital structure ahead of the launch, subject to approval, of new products, including the Company's biosimilar insulin glargine product, the Company is in discussions with key secured creditors regarding a potential recapitalization or restructuring of its capital structure. While the Company cannot provide any assurance as to if or when it will consummate any such transactions or the terms of any such transactions, the Company expects to be able to reach an agreement with its key secured creditors in the near term on such a transaction. Any such potential transaction may involve the restructuring of all or a material portion of the Company's outstanding debt, including the exchange of all or a material portion of the secured debt for new common stock or other equity. Holders of the Company's common stock and convertible notes may not receive any value or payments in a recapitalization, restructuring or similar transaction and/or may experience material dilution or the loss or cancellation of their investment. The terms of any transaction will depend on prevailing market conditions, the Company's liquidity requirements and cash position, contractual restrictions, trading prices of debt from time to time and other factors.
As such, the Company elected to defer an interest payment on certain of the Company's unsecured convertible notes and enter a 30-day grace period. The Company's election to not make the interest payment was not driven by liquidity constraints as the Company has approximately
"We are working with our secured lenders to evaluate options to strengthen and restructure our balance sheet and position the Company for success well into the future," said Crew. "We continue to be focused on providing life-enhancing generic pharmaceutical products to our valued customers and the patients who rely on our medications, and today's decision to enter the grace period will not impact day-to-day operations or these efforts."
Lantus® is a registered trademark of
About
This press release contains forward-looking statements which are not historical facts made pursuant to the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not promises or guarantees and investors are cautioned that all forward-looking statements involve risks and uncertainties, including but not limited to the impact of competitive products and pricing, product demand and market acceptance, new product development, acquisition-related challenges, the regulatory environment, interest rate fluctuations, reliance on key strategic alliances, availability of raw materials, fluctuations in operating results, our ability to remain listed on the
The information in this press release should be read in conjunction with information in the Company's filings with the
Advisors
Contact: | |
(424) 288-4098 |
View original content to download multimedia:https://www.prnewswire.com/news-releases/lannett-shares-update-301789190.html
SOURCE
FAQ
What were the results of Lannett's insulin trial?
What is Lannett's plan regarding its Biologics License Application?
What financial challenges is Lannett currently facing?
How much cash does Lannett currently have?