For the third quarter 2016, MannKind Corporation reported total sales of $162m, reflecting the recognition of several previously deferred amounts – including a $150m upfront payment - related to the firm’s Afrezza commercialisation collaboration with Sanofi which terminated in January.
This has played a part in positioning MannKind in its best financial health since Sanofi abandoned the deal, and according to CEO Matthew Pfeffer the firm can now concentrate on growing Afrezza sales which have been historically disappointing.
Third quarter sales of Mannkind-branded Afrezza – launched in July – stood at $600,000.
Two-and-a-half insulin units per Afrezza cartridge
Afrezza became the only inhaled rapid-action insulin available in the US when it was launched in February 2015. But the price of the product, due in part to its manufacturing costs, contributed to a low uptake.
The product is based on MannKind’s Technosphere platform, comprising of the excipient fumaryl diketopiperazine (FDKP), water and the non-ionic surfactant polysorbate 80 which are mixed and crystallised into uniform particles of 2 microns in diameter in combination with recombinant human insulin.
“Inhaled medications tend to be somewhat less efficient than injected medications, as you have some loss of powder. Only the powder that makes it into the deep lung is taken into the bloodstream, to the effect that some is left in the throat, it is swallowed and digested, having no effect.” Pfeffer told in-Pharmatechnologist.com. “Injected insulin has some loss in the syringe, etc., but this is much less.”
Pfizer’s Exubera – an inhaled insulin product approved in 2006 and pulled a year later – was very inefficient, Pfeffer continued, “requiring roughly twelve times the of insulin (in standard international units) to deliver the same effect as what was injected.”
Afrezza meanwhile is more advanced, but not one-for-one he added. “A four unit cartridge of Afrezza is made with ten units of insulin.”
Price freeze
But there are other costs of delivering insulin than just the raw material component, he said. “Our molded plastic inhaler, for example, is much less expensive than a pen injector, or even syringes and vials.”
Coupled with rivals significantly increasing their prices over the last 24 months since Afrezza’s launch, the “bottom line is price is not really an issue for us,” Pfeffer stated. “We no longer have a price higher than injected insulin, partly because unlike injected insulins, we have never raised our price, making our list price actually a little lower than pen delivered insulin.”
Sanofi sell back
Other financial actions by MannKind in the quarter included a 20% drop in staff, plans to sell its Valencia, California facility for $25m, and a $65m reduction in projected spend with insulin supplier Amphastar.
Meanwhile, Sanofi – through its affiliate Aventisub – has canceled an outstanding loan of $71.6m while the French pharma firm has agreed to buy back $10.2m worth of insulin from MannKind in early December.
“Now that we have launched Afrezza and established our infrastructure, we expect to increase our investments to grow Afrezza sales faster,” Pfeffer told investors last week. “Based on everything we have planned, we expect our current financial resources to last into Q3 of 2017.”