JP Morgan Tuesday Afternoon
As expected the afternoon session was full of news starting with the presentation by MannKind (NASDAQ:MNKD). According to company founder Al Mann the reason the FDA delayed the approval of Afrezza™ did have to do with a plant inspection and to his knowledge is not related to any other issue. Just as reminder this past Friday the company issued a press release which stated; “The FDA explained that it has not yet completed its inspection of the insulin manufacturing facilities of N.V. Organon, a third-party supplier to MannKind. Organon is a subsidiary of Merck Inc. MannKind’s new drug application references Organon’s drug master file for recombinant human insulin.”
Over the weekend reports began to surface that the plant inspection was completed which in turn lead to speculation that there was some alternate explanation for the approval delay. According to Mr. Mann Organon actually has two different plants which need to be inspected and one has been inspected and the other has not been inspected. While he couldn’t say for certain he believes the second plant will be inspected shortly and Afrezza will be approved.
Not surprisingly Mr. Mann spoke to an overflowing crowd which just goes to prove that there are still many fans of inhaled insulin. And once again Mr. Mann didn’t disappoint anyway boldly predicting MannKind shares could one day hit $20 per share. And as has become standard fair for the company the long awaited partnership is just months away.
Diabetic Investor could go on here but frankly we’ve been down this road too many times before and it’s about time for MannKind to put up or just shut up. Like the teenager who never admits that anything is their fault it always seems like MannKind has some type of explanation as to why things aren’t going their way. The delay at the FDA isn’t their fault it’s the FDA’s mistake. The reason they don’t have a partner isn’t because partners see the same hurdles as Diabetic Investor does, it’s because MannKind has the greatest product in the world and they want the “right” partner.
The truly sad part here is that Afrezza is actually a very good product that unfortunately is delivered through the lungs. There is place for Afrezza, albeit as a niche product, however given the way Mr. Mann boosts about what Afrezza can do there’s no way it can ever live up to the hype. To Diabetic Investor, MannKind’s statements fall into the classic over promise under deliver category. With Afrezza on the brink of approval it’s time for the boosting to end and the action to begin. As the old saying goes; Talk is cheap and if Afrezza doesn’t live up to the hype that’s exactly what’s going to happen to MannKind’s stock price.
Moving on to one of the many companies that gave up on their inhaled insulin project, Lilly (NYSE:LLY) also presented this afternoon. Given that Byetta LAR is just weeks away from approval Diabetic Investor was particularly interested in whether the company would continue their schizophrenic attitude towards the drug. And as has become the norm Lilly didn’t disappoint once again touting their own GLP-1 candidate although it remains in early Phase 2 trials. When asked about why they continue to talk up this very early stage compound the company once again was the company with two faces. First they made clear that they strongly support LAR adding that their own GLP-1 was in the pipeline before they had a relationship with Amylin (NASDAQ:AMLN). Just in case you don’t understand corporate speak allow Diabetic Investor to translate, THEY DIDN’T ANSWER THE QUESTION.
When asked if they would follow Sanofi-Aventis (NYSE:SNY), who early in the day indicated they could be entering the glucose monitoring space, the company stated they preferred to stay in the drug business. Not exactly a bad move when you look at the realities of the glucose monitoring market and add in the fact that should LAR be as successful as Diabetic Investor anticipates that would place another nail in the BGM coffin.
Going back to the Lilly – Amylin relationship Diabetic Investor asked the company who has publicly stated their aversion to a large merger or acquisition just what type of company they would acquire, once again we were hit with an avalanche of corporate speak. Simply put, while we can’t rule out Lilly acquiring Amylin the collective actions by both companies don’t point in that direction, at the moment. This could change in a hurry should LAR prove to be the mega-blockbuster Diabetic Investor anticipates.
Overall today there were few surprises, if we had to pick a winner Diabetic Investor would say Dexcom (NASDAQ:DXCM) and Sanofi-Aventis were shard the prize. Dexcom continues to make excellent progress while Sanofi looks to have the most compelling diabetes strategy. About the only thing missing from the Sanofi portfolio is a solid GLP-1, wonder who has one?