MannKind Corporation (NASDAQ:MNKD) CFO presented at Jefferies Global Healthcare Conference on June 2. The biopharmaceutical company and its shareholders are eagerly anticipating the approval of Afrezza on July 15. USFDA had delayed the Prescription Drug User Fee Act (PDUFA) review of the diabetes drug from April 15 to July 15. Brinson Patrick analyst Christopher James recently said in a research note that Afrezza, if approved, could generate as much as $3.65 billion in annual revenues by FY2025. The analyst believes that the approval could come even before July 15.
MannKind’s Afrezza has huge revenue potential
MannKind Corporation (NASDAQ:MNKD) CFO Matt Pfeffer avoided talking about the FDA progress and potential commercial partnerships. Pfeffer said diabetes is one of the most widespread health problems in the world. As a consequence, the use of insulin for diabetes is also growing. Insulin demand is not very high yet as people are reluctant to take it because they consider it the last option. But he expects that there will be at least 500,000 new insulin users every year.
The traditional methods of taking insulin are still inconvenient and painful. In contrast, Afrezza is very easy to use. Patients can self-administer the recombination human insulin power through oral inhalation, which is then absorbed by lungs. The market for rapid-acting catalogs is growing at 22% annual rate, mainly because of additional patients. That’s about $4 billion of sales in the U.S. alone, and only for existing rapid-action catalogs. A large number of diabetics are reluctant to use rapid-action insulin, MannKind Corporation (NASDAQ:MNKD) expects that its Afrezza can attract a large number of these patients.
MannKind’s Danbury facility can produce up to two billion cartridges
Talking about commercialization of the drug, MannKind Corporation (NASDAQ:MNKD) CFO said that the company has a state-of-the-art facility in Danbury, Connecticut. The company didn’t fully built the facility because that would have been quite expensive, especially when the drug is yet to be approved. Once fully built out, the facility can produce up to two billion cartridges a year. So, the key challenge before the company is to install the equipment that could fill two billion cartridges.
MannKind Corporation (NASDAQ:MNKD) shares jumped 2.92% to $9.29 at 12:54 PM EDT on Tuesday. The stock has soared to a 3-year high.