- Third quarter 2021 net revenues of $52.1 million; net loss of $4.4 million and diluted loss per share of ($0.37) --
-- Third quarter adjusted non-GAAP EBITDA of $16.6 million and adjusted non-GAAP diluted earnings per share of $1.01 --
-- FDA approves supplemental new drug application for Purified Cortrophin™ Gel for the treatment of certain chronic autoimmune disorders; full-scale launch planned for early Q1 2022 --
-- Acquisition of Novitium Pharma LLC is expected to close in November 2021 --
-- Launched Nebivolol Tablets simultaneously from two manufacturing sites --
ANI Pharmaceuticals, Inc. (ANI or the Company) (NASDAQ: ANIP) today announced business highlights and financial results for the three months ended September 30, 2021.
Third Quarter and Recent Business Highlights:
The U.S. Food and Drug Administration (FDA) approved the Company’s supplemental new drug application (sNDA) for Purified Cortrophin™ Gel (Repository Corticotropin Injection USP) (Cortrophin Gel) for the treatment of certain chronic autoimmune disorders, including acute exacerbations of multiple sclerosis and rheumatoid arthritis, in addition to excess urinary protein due to nephrotic syndrome.
The Company plans full-scale Cortrophin Gel launch in the first quarter of 2022.
The acquisition of Novitium Pharma LLC is expected to close in November 2021; and
Launched Nebivolol Tablets simultaneously from two manufacturing sites. Nebivolol is the generic version of the reference listed drug (RLD) Bystolic®.
Third Quarter 2021 Financial Highlights:
Net revenues were $52.1 million compared to $53.0 million in Q3 2020.
GAAP net loss was $4.4 million and diluted GAAP loss per share was ($0.37).
Adjusted non-GAAP EBITDA was $16.6 million.
Adjusted non-GAAP diluted earnings per share was $1.01.
Cash and cash equivalents were $15.3 million, net accounts receivable was $106.7 million, and face value of debt was $202.9 million as of September 30, 2021.
"The approval of Cortrophin Gel marks a critical milestone for ANI. During the past five years, we have made a significant investment in establishing and updating manufacturing processes and ensuring a sustainable, U.S.-based supply chain for this important product. Physicians now have a much-needed treatment option for patients with acute exacerbations of multiple sclerosis and rheumatoid arthritis, as well as nephrotic syndrome, who can benefit from a repository corticotropin. We have built an experienced rare disease leadership team to drive a full-scale commercial launch early in the first quarter of 2022," said Nikhil Lalwani, President and CEO of ANI.
