Lannett Company, Inc. (NYSE: LCI) is dedicated to providing patients and customers with safe, affordable, effective, and life-enhancing generic pharmaceutical products. To ensure continued success and growth, the Company is focused on strategically positioning itself and is proud to share an update on its progress.
The Company, in collaboration with its strategic partners within the HEC Group of companies, is proud to report that its pivotal clinical trial of biosimilar insulin glargine has achieved positive results in line with prior expectations.
This single center, double-blind, randomized, two-period, two-treatment, two-sequence, crossover study was designed to demonstrate PK and PD similarity between the Company’s biosimilar insulin glargine and US-Lantus® using the euglycemic clamp technique in healthy male adult volunteers. The study met all of its primary and secondary endpoints with no serious adverse events reported, thus proving the similarity of the Company’s insulin glargine to the reference product.
We are thrilled with the positive results of the pivotal clinical trial of our biosimilar insulin glargine! Our team is fully committed to bringing this product to market and unlocking its immense commercial potential. At Lannett, we remain optimistic and excited about the possibilities that this biosimilar insulin glargine offers.
Lannett is racing to submit its Biologics License Application to the FDA within the upcoming months. Prior to filing, the company will be conducting a device differentiation study in April and further comparability work demonstrating that HEC’s insulin glargine is biosimilar to US sourced Lantus.
Additionally, Lannett is planning to meet with the FDA in a pre-submission meeting. Although there are numerous steps necessary to gain FDA approval and successfully commercialize the product, Lannett is working diligently to make it happen.
Lannett is thrilled with the recent developments in the insulin market, such as manufacturers lowering the price of insulin for patients and increasing market transparency. These initiatives are sure to open the door for greater access to this vital medicine, and Lannett is proud to be at the forefront of driving this effort forward with a promising go-to-market approach.
Financial Update
The Company is currently in discussions with its key secured creditors on a potential recapitalization or restructuring of its capital structure, in order to maintain its competitive edge and to prepare for the launch of its new products, including its biosimilar insulin glargine product.
Although there is no guarantee of when or how such a transaction will be completed, the Company is confident that an agreement with its key secured creditors can be reached in the near future. This potential transaction could involve the restructuring of all or a portion of the Company’s outstanding debt, including the exchange of all or part of the secured debt for new common stock or equity.
Unfortunately, holders of the Company’s common stock and convertible notes may not receive any value or payments, or could even experience severe dilution or the loss or cancellation of their investment.
The terms of any transaction will depend on a variety of factors, such as prevailing market conditions, the Company’s liquidity needs and cash position, trading prices of debt, and contractual restrictions.
The Company has elected to defer an interest payment on certain of its unsecured convertible notes and enter a 30-day grace period. Despite having approximately $47 million of unrestricted cash as of March 31, 2023, this decision was not driven by liquidity constraints.
If the Company does not make the interest payment within the 30-day grace period, it will constitute an event of default under the indenture and the trustee or holders of at least 25% in aggregate principal amount of the outstanding convertible notes may demand full payment of principal and accrued and unpaid interest immediately.
Today, we are taking the necessary steps to ensure our company’s long-term success by working with our secured lenders to evaluate options to strengthen and restructure our balance sheet. We remain dedicated to providing our customers and patients with life-enhancing generic pharmaceutical products, and entering the grace period will not disrupt our operations or our commitment to excellence.
About Lannett Company, Inc.:
Lannett Company has been a cornerstone of the pharmaceutical industry since 1942, providing generic medications to help people around the world manage a variety of medical conditions. Their comprehensive suite of offerings includes development, manufacturing, packaging, marketing and distribution services, ensuring that the highest quality of care is provided to each and every customer.