Earnings release
Page 1
#Lannett Q1 Business and Financial Highlights : Contact : Robert Jaffe Robert Jaffe Co. , LLC ( 424 ) 288-4098 LANNETT REPORTS FISCAL 2022 FIRST - QUARTER FINANCIAL RESULTS ; REVISES DOWN FULL - YEAR GUIDANCE Net Sales were $ 102 Million , Exceeding Expectations Adjusted EBITDA was $ 10 Million Cash Increased to More Than $ 105 Million at September 30 --Company Announces Restructuring Plan Targeting $ 20 Million in Reduced Expenses , To Consolidate Manufacturing Operations and Restructure the R & D Function- Exhibit 99.1 Durable Product Pipeline Updates : § Generic Advair Diskus® ANDA Continues to Progress , FDA Provides Feedback § Insulin Glargine IND Application On Track for December 2021 Submission Philadelphia , PA - November 3 , 2021 - Lannett Company , Inc. ( NYSE : LCI ) today reported financial results for its fiscal 2022 first quarter ended September 30 , 2021 . " For the quarter , solid sales of several key products contributed to our better than expected topline , " said Tim Crew , chief executive officer of Lannett . " Our gross margin however , was lower than anticipated , largely due to increasing competitive pressure on our base portfolio and product mix . Our strong cash position at September 30 , 2021 grew to more than $ 105 million from approximately $ 93 million at June 30 , 2021 . " Our pipeline of large durable assets continues to progress . As previously stated , we believe all five disclosed products could be approved , or tentatively approved , by 2025 , with the product closest to commercialization , generic ADVAIR DISKUS® , possibly launching next fiscal year , and the potentially transformational biosimilar Insulin Glargine currently expected to launch in fiscal year 2024 . " Recently , the FDA provided mid - cycle discipline review comments on the pending Abbreviated New Drug Application ( ANDA ) for our generic Advair Diskus product . We are working to address the FDA's helpful comments and intend to respond to as many of the Agency's requests as possible before the FDA due dates . We expect to receive additional comments from the FDA on the FDA - assigned goal date of January 31 , 2022. As previously disclosed , we expect to have more than one review cycle for the ANDA . Regarding our biosimilar insulin glargine product , we remain on track for submitting the Investigational New Drug ( IND ) Application next month and commencing the pivotal trial around March 2022 .