MannKind Corp. has announced that it has submitted paperwork in Brazil to seek approval of its sole product, Afrezza. The company also announced it will be restructuring its outstanding debt obligations.
The Westlake Village biotech company is working with BIOMM, a Brazilian biopharmaceutical company, to secure government approval. BIOMM will also handle promotion, sales and distribution of Afrezza in Brazil.
“We are excited to file our first international application for approval of Afrezza in Brazil, which is in the top 10 countries with the highest diabetes rates in the world, according to the World Health Organization,” Michael Castagna, chief executive of MannKind, said in a statement.
The company also announced restructuring of its debt obligations, announcing that it has extended the maturity of $10 million of its Deerfield credit facility from Oct. 31 to Jan. 15 of next year, and allowed for some outstanding principle to be converted into common stock.
The company also will exchange senior convertible notes of $27.7 million due in August for $23.7 million due in October 2021 and nearly 1 million shares of common stock.
“These transactions, in combination with the recent registered direct offering, are expected to enable us to execute our near-term business plan,” Castagna said in a statement.
Shares of MannKind (MNKD) on Monday fell 41 cents, or nearly 10 percent, to $3.70 on the Nasdaq.