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Lannett (LCIN) : 0.149 - 35.22%
today: 149 - 0.285
52w: 0.149 – 3.72
mktcap: 1.6 million
https://www.findacode.com/ndc/labelers/Lannett_Company%2C_Inc.


Shares Outstanding 10.77M
Float 8.39M

Total Cash (mrq) 55.85M
Total Debt (mrq) 635.37M

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 HEC Group of companies (HEC). The single center, single-dose, double-blind, randomized, two-period, two-treatment, two-sequence, crossover study was designed to demonstrate pharmacokinetic (PK) and pharmacodynamic (PD) similarity between Lannett/HECs 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 and no serious adverse events were reported. The data from the pivotal trial of the Company's biosimilar insulin glargine indicate that its insulin glargine is biosimilar to the reference product.

"We are pleased with the results of this crucial clinical trial of biosimilar insulin glargine," said Tim Crew, chief executive officer of Lannett. "We remain confident that biosimilar insulin glargine represents a significant commercial opportunity, and our team is diligently focused on advancing this product."

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.

Q2 Business and Financial Highlights:
• Net Sales were $80.9 Million
• Gross Margin was 18%, Adjusted Gross Margin was 19%
• Net Sales, Gross Margin and Adjusted Gross Margin Up Versus Preceding Two Quarters
• $19 Million Income Tax Refund Received, Cash Balance of $56 Million at December 31st
Pipeline Updates:
• Pivotal Biosimilar Insulin Glargine Clinical Trial Top-line Results Anticipated in Current Quarter; BLA Filing Targeted for Middle of Calendar 2023
• Positive Results from Study of Biosimilar Insulin Aspart vs US NovoLog®; Commencement of Pivotal Trial Anticipated by Fall of Current Year
• Executed Sub-License Agreement Related to Insulin Pen Delivery Device, Improving Ability to Freely Market Insulin Products Upon Approval
• Generic FLOVENT® DISKUS® ANDA Filing Anticipated by Mid Year

Apr 24, 2023 0.2300 0.2850 0.2094 0.2850 0.2850 40,646
Apr 21, 2023 0.3500 0.3500 0.2300 0.2300 0.2300 668,300
Apr 20, 2023 0.6600 0.7000 0.2500 0.3330 0.3330 1,167,800
Apr 19, 2023 0.6500 0.7196 0.6501 0.6855 0.6855 280,660
Apr 18, 2023 0.6530 0.6829 0.6530 0.6600 0.6600 30,585
Apr 17, 2023 0.7000 0.7000 0.6525 0.6525 0.6525 39,745
Apr 14, 2023 0.6400 0.7200 0.6375 0.6900 0.6900 129,657
Apr 13, 2023 0.6400 0.6960 0.6400 0.6700 0.6700 60,850
Apr 12, 2023 0.7600 0.7700 0.6600 0.6620 0.6620 126,490
Apr 11, 2023 0.9400 0.9478 0.7200 0.7221 0.7221 185,385
Apr 10, 2023 0.9750 0.9800 0.9067 0.9179 0.9179 30,979
Apr 06, 2023 0.9400 0.9500 0.9100 0.9205 0.9205 72,475
Apr 05, 2023 0.9800 0.9975 0.9300 0.9539 0.9539 312,304
Apr 04, 2023 1.8500 1.8500 0.8600 0.9700 0.9700 982,984
Apr 03, 2023 1.6800 1.8900 1.6800 1.8700 1.8700 25,574