09/04/2018
DD&F Strategy - What's Up with MannKind and Afrezza
Published Week of March 19, 2018 in
PharmaCircle Formulation & Drug Delivery Newsletter
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MannKind serves as a something of a bellwether for next generation drug delivery companies, particularly companies pursuing inhaled macromolecules. Once it became apparent that MannKind’s Afrezza was going to fall far short of blockbuster status and Sanofi signed off, the question was what was next for the company. MannKind at the time stated that it intended to stay the course, take on Afrezza commercialization activities internally, and refocus the product to better align its benefits with patient needs.
It has been two years since the Sanofi announcement. In the meantime MannKind has restructured and refocused their efforts with Afrezza. The results to date have been disappointing. Afrezza sales in 2017 came in at a little more than $9 million, but on a positive note half of that total was earned in the 4th quarter suggesting there was a late year uptick in use of the product. What was a little disappointing was that cost of goods for 2017 was almost twice the reported sales. This is often the case with products early in their lifecycle where fixed costs overwhelm the low sales levels. One brokerage firm is forecasting that Afrezza sales will grow to $25 million in 2018, $253 million by 2021 and $583 million by 2023. The cost of goods by 2023 are expected to be about 25% of sales, a high but not unreasonable figure. There are few brokerage firms covering MannKind, none of which are as optimistic with sales at best half those listed earlier.
The MannKind development pipeline has been severely trimmed in the past two years. MannKind’s Epinephrine Technosphere, touted as offering an attractive alternative to injection for acute anaphylaxis is listed as available for license, as is their Palonesteron Technosphere for CINV. The great hope at MannKind seems to be Treprostinil Technosphere for pulmonary arterial hypertension. This last opportunity makes sense for an inhalation product, it acts locoregionally and is a small molecule, but it will enter a market that already has numerous dosing options including oral.
Using MannKind as a model for a Drug Delivery/Specialty Pharma strategy suggests that the decades old approach of evolving from a drug delivery platform company to a product licensing company to an independent commercially integrated company is now a stretch, at best. At this stage MannKind is so far in the hole it’s hard to see how they can dig themselves out. But, what’s spent is spent as long as it doesn’t exist as debt. Opportunity exists if value can be created from what remains. In the case of MannKind it all rests on Afrezza. If the company can hit the $500 million annual sales mark with Afrezza it might be able to provide a handsome reward to new investors who bought in at the bottom along with management who earned options at the bottom as well. That is of course making the absolute best of a very bad situation. Any emerging company with drug delivery or formulation technology might better consider the approach taken by Nektar since its own inhaled insulin disaster. Cut your losses and invest in something that has the potential to provide more reward, damn the incremental evolution strategy, even if a big leap may carry more risks.
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