Investors in inhalable-insulin maker MannKind Corp. likely need to catch their breath.
They learned last week that the Valencia pharmaceutical firm’s business partner, Sanofi-Aventis U.S., will terminate its licensing agreement to market and sell MannKind’s only product, Afrezza.
The news sunk MannKind’s stock. Overall, the firm’s shares shed 51 percent to close at 73 cents the week ended Jan. 6, making it the biggest loser on this week’s LABJ Stock Index. (See page 32.)
MannKind announced Jan. 5 that the Bridgewater, N.J., division of French pharmaceutical behemoth Sanofi will transition the development and commercialization of Afrezza to the Valencia firm over the next 90 to 180 days. MannKind added that it’s reviewing strategic options.
“Although this news is obviously not what we anticipated when MannKind commenced the partnership with Sanofi in August of 2014, it became clear as 2015 progressed and sales forecasts were not met, the change would be required if Afrezza were to achieve the market success that we believed and still believe should be possible,” said MannKind Chief Financial Officer Matthew J. Pfeffer in a conference call last week.
Chicago-based Morningstar Inc. analyst Stefan Quenneville said it really limits the outlook for Afrezza, which once looked like a relatively promising drug.
“It leaves MannKind in a very precarious situation,” he added.
Quenneville said the firm will likely try to secure another partner, or possibly – in an extreme case – handle commercialization itself. Granted, it might be hard to find someone else willing to take on Afrezza after such a strong partner as diabetes market leader Sanofi failed to get much traction in initial attempts to sell the drug.
That leaves MannKind burning cash with a relatively limited amount of runway, Quenneville added.
Although the firm wasn’t clear about its plans, Quenneville surmised that in addition to finding another partner, MannKind would likely need to make cuts to slow cash-flow burn or even explore selling the business.
“We’ve had difficult situations before and have prevailed,” Pfeffer said on last week’s conference call.
Representatives from MannKind could not be reached for comment.
The Valencia firm is one of the latest endeavors of prolific biotech entrepreneur Alfred E. Mann, 90, who has launched and largely funded 17 companies, 10 of which were acquired for a total of almost $8 billion.
But despite his previous successes, MannKind has faced many obstacles. It labored through a long Food and Drug Administration approval process and brought Afrezza to market in the shadow of Pfizer Inc.’s earlier failure to successfully market another inhalable-insulin drug.
Afrezza had also faced challenges getting covered by insurers in a timely manner, Quenneville said, noting that some doctors took longer than expected to write prescriptions for patients because they didn’t have the necessary tools in their office to conduct the required lung-capacity test.
“It is like a lot of new technologies,” said Quenneville, “It seemed innovative, but changing people’s habits and ways of doing things is difficult.”
