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Post by peppy on Jan 7, 2018 19:07:55 GMT -5
Aged... Did Sanofi fail to sell the drug or did the incoming chief abort the effort prematurely because of his prior experience with exubera? There's a big difference. Clearly Sanofi failed to sell the drug - the numbers tell the story. Was there a better way? Yes - it turns out that it takes a dedicated in-house sales force, but that is not Sanofi's operating model and they are not about to change their entire sales model for a drug they don't even own. Mannkind on the other hand didn't have a choice, they had to find a model, and they had to make it work. Ultimately they took three swings to get there (partnership, contract sales, in-house sales). Sanofi made the right choice for Sanofi at the time. Mannkind management failed by not having contingency a plan for what to do if Sanofi did terminate. I confess I never saw it coming (that's where my first LEAP holding went down in flames) however it's their job to do that planning, especially when the sales started to drop towards the end and the risk of Sanofi exiting started to rise. clearly Sanofi failed to start a label change with the clamp data they had and failed to obtain health insurance for the drug.
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Post by mnholdem on Jan 7, 2018 19:17:04 GMT -5
Keith Speights: The Sanofi (NYSE:SNY) deal was before your time at MannKind, but why do you think Sanofi wasn't successful in its commercialization of Afrezza? Michael Castagna: In general, you usually take years to prepare for a drug launch. Remember the drug was approved in roughly April 2014, licensed in August 2014, and launched six months later in February 2015. So basically, the Sanofi team had six months to prepare a launch, which you normally take years preparing. That was probably the biggest challenge to begin with.And then they brought over a person from Europe to head up the launch who didn't have a lot of experience in the U.S. market. So when it came to making decisions around pricing and managed care strategies and reimbursement, you know it's a very different healthcare system in the U.S. versus Europe.It wasn't the No. 1 priority that Sanofi had. They had another major drug launch in cardiovascular disease with Praluent. And they had another major threat against Lantis with a biosimilar from Lilly. So they were preparing to defend Lantis by launching Toujeo. So they just had a lot of other priorities. Having worked in large companies for most of my career, having two big launches in a year is tough enough rather than having three. So this probably was just their third priority, is my guess.It's [Afrezza] not like regular insulin. They tried to think about how to use sub-q [subcutaneous] insulin and said, "I know how to use sub-qs; that's how I'll use Afrezza." And it's a different product. It's got different dosing. You use it at mealtime, but it's not a 1-to-1 ratio. I think that the No. 1 mistake that they made out the door was not talking about the PK/PD [pharmacokinetics/pharmacodynamics] and the difference -- how you would think about the dosing and titrating up. People forget, they had Apidra, which competes against Lilly and Novo Nordisk, and they didn't succeed with that, either. I wasn't here, but what makes you think they're going to succeed with another mealtime insulin when they couldn't do one on their own?Source: www.fool.com/investing/2017/11/19/an-interview-with-mannkind-ceo-michael-castagna.aspx
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Post by sportsrancho on Jan 7, 2018 19:47:35 GMT -5
Castagna: I have expressed publicly that we're open to a co-promote partner. To me, this is our lead asset. I was actually a shareholder of MannKind when they got [Afrezza] approved. When they gave it to Sanofi, I sold my shares. And not because I didn't love the company, but to me the entire value of the company was Afrezza. So there were no other pipeline compounds close enough that would continue to drive value.
Now, I think we can grow a lot faster, and there's a lot more people that we can help, because we're not going to target 50,000 primary-care physicians. But there are a lot of patients, and that's where a lot of them sit -- in the type 2 market. So as we continue to expand and fix coverage, and the package is now fixed, we're open to a co-promote partner, which means you would take another large company's 300 to 500 reps, and you would drop this in their bag as a secondary position. And now we can train them and do a lot better.
Speights: Do you think that continued success of Afrezza on your own could draw the attention of larger partners?
Castagna: Yeah, I think we've already demonstrated that we've surpassed Sanofi's sales curves. And we've done that on one-seventh of the resources. I think our success is already there. We've already beat them. So just think if we had the money Sanofi has, we'd be blowing it out of the park right now. And we don't. We've run the company very resource constrained for the last year. But I think the reality is that if we had more reps or more money, we'd be growing even faster.
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Post by timri on Jan 7, 2018 20:08:19 GMT -5
Castagna: I have expressed publicly that we're open to a co-promote partner. To me, this is our lead asset. I was actually a shareholder of MannKind when they got [Afrezza] approved. When they gave it to Sanofi, I sold my shares. And not because I didn't love the company, but to me the entire value of the company was Afrezza. So there were no other pipeline compounds close enough that would continue to drive value. Now, I think we can grow a lot faster, and there's a lot more people that we can help, because we're not going to target 50,000 primary-care physicians. But there are a lot of patients, and that's where a lot of them sit -- in the type 2 market. So as we continue to expand and fix coverage, and the package is now fixed, we're open to a co-promote partner, which means you would take another large company's 300 to 500 reps, and you would drop this in their bag as a secondary position. And now we can train them and do a lot better. Speights: Do you think that continued success of Afrezza on your own could draw the attention of larger partners? Castagna: Yeah, I think we've already demonstrated that we've surpassed Sanofi's sales curves. And we've done that on one-seventh of the resources. I think our success is already there. We've already beat them. So just think if we had the money Sanofi has, we'd be blowing it out of the park right now. And we don't. We've run the company very resource constrained for the last year. But I think the reality is that if we had more reps or more money, we'd be growing even faster. Amazing that mike was smart enough to sell his shares after sanofi took over. We were all jumping for joy and he was dumping his shares bc he knew better. I think this shows you how smart of a guy he is.
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Post by sportsrancho on Jan 7, 2018 20:43:22 GMT -5
Exactly! How many here sold their shares when we partnered with SNY, and bought recently? Not me... The smart one, the one running the company:-)
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Post by timri on Jan 7, 2018 20:52:02 GMT -5
Exactly! How many here sold their shares when we partnered with SNY, and bought recently? Not me... The smart one, the one running the company:-) Sports I bought some at 10 lol I even talked my boss into buying some at 10. Epic fail. He still rags on me for that trade. Last time I told anyone to buy anything. We all thought we were the next REGN when we signed with sanofi.
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Post by sportsrancho on Jan 7, 2018 20:57:18 GMT -5
Exactly! How many here sold their shares when we partnered with SNY, and bought recently? Not me... The smart one, the one running the company:-) Sports I bought some at 10 lol I even talked my boss into buying some at 10. Epic fail. He still rags on me for that trade. Last time I told anyone to buy anything. We all thought we were the next REGN when we signed with sanofi. I talked my security guard at the condo complex I lived in to buy at $10. Luckily I got my boss in at $5. But that was pre-split, so my name is dirt:-)
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Post by akemp3000 on Jan 7, 2018 21:32:19 GMT -5
Sports - You probably have a lot of relatives on here whose name is also "Dirt" including myself who once shared enthusiasm only to have to tuck tail and remain silent since. That's ok. Hopefully, the Dirt family reunion will be epic later this year.
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Post by slugworth008 on Jan 7, 2018 22:55:45 GMT -5
Exactly! How many here sold their shares when we partnered with SNY, and bought recently? Not me... The smart one, the one running the company:-) Sports I bought some at 10 lol I even talked my boss into buying some at 10. Epic fail. He still rags on me for that trade. Last time I told anyone to buy anything. We all thought we were the next REGN when we signed with sanofi. Let's not forget - That Vienbacher was SNY's CEO when they partnered with SNY. Hindsight really sucking right now...but in hindsight when they sacked Chris - I should have bailed and taken a slight loss - Brutal lesson learned. Of course I know I would have bought back in at some point and still endured the 5/1 RS. Awesome sauce.
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Post by mnholdem on Jan 7, 2018 23:00:05 GMT -5
Today we might do well to remember this: The lesson is not over yet.
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Post by mytakeonit on Jan 8, 2018 1:28:17 GMT -5
Don't worry sports ... I love dirty girls. Hopefully, the pps goes down more in the next few days and I can load up for my daughter and myself.
Then ... we can run to $6 for baba "the cry baby". Ha!
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Post by #NoMoreNeedles on Jan 8, 2018 4:55:44 GMT -5
Just adding to the fire and fury: When are we going to see a new Chief Medical Officer joining?
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Post by hammer on Jan 8, 2018 7:32:25 GMT -5
Until which year Afrezza patent is valid before other companies come up with Generic drug replacing Afrezza? The presentation at Cantor conference had a slide covering patents. It said that the FDA Orange Book patents covering Afrezza extend to 2032. Even after that point it may be more difficult than a typical generic drug to replicate Afrezza since it is a complicated device drug combo. What would a company need to do to prove that their copycat cartridges, inhaler and powder (particle size, uniformity, etc.) perform exactly the same as Afrezza? Is there possibility a copycat would need to go through its own expensive set of clinical trials to prove equivalence? (don't know the answers to these questions) Concern for others copying Afrezza is very far down on my list of what I'm concerned about. I have to respectfully disagree with your post. The intellectual property behind Afrezza is what its all about. Re read the agreement with SNY and how important it was to SNY if they developed their own ability to develop a similar drug and how they would basically kick MNKD to the street (they did anyway) if they were successful. 2032 is only 14 years away. That is not a whole lot of time for a partner to bring the drug to blockbuster status in the current environment and have a sufficient runway to make profit to make it all worth while. Sure you can strengthen the intellectual property but it does not guaranty the runway since advancements in delivery can happen at anytime. The shorter the patent protection becomes the less Afrezza is worth period! Currently if a partner were to come on board they would perhaps have 10 years to reap profits vs 20. SNY caused great damage to Afrezza from this standpoint, my only hope is that it is not irreparable damage. I happen to be more cynical about the motivations of SNY. They were preserving and protecting a dynasty, thier actions with MNKD are similar to their interaction with other companies. Exclusively control it, injure it and hopefully it will die of its own accord with shortening of the patent window so no other Pharma may take interest.
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Post by agedhippie on Jan 8, 2018 8:22:48 GMT -5
Clearly Sanofi failed to sell the drug - the numbers tell the story. Was there a better way? Yes - it turns out that it takes a dedicated in-house sales force, but that is not Sanofi's operating model and they are not about to change their entire sales model for a drug they don't even own. Mannkind on the other hand didn't have a choice, they had to find a model, and they had to make it work. Ultimately they took three swings to get there (partnership, contract sales, in-house sales). Sanofi made the right choice for Sanofi at the time. Mannkind management failed by not having contingency a plan for what to do if Sanofi did terminate. I confess I never saw it coming (that's where my first LEAP holding went down in flames) however it's their job to do that planning, especially when the sales started to drop towards the end and the risk of Sanofi exiting started to rise. clearly Sanofi failed to start a label change with the clamp data they had and failed to obtain health insurance for the drug. It is likely the only reason Sanofi did the clamp test at all was because they were contractually obligated to do so as part of the partnership agreement since it was an FDA requirement. Since by the time the results came out they had decided to leave they never progressed beyond what they were obliged to do by the letter of the contract. I don't particularly fault Sanofi for the insurance. That was always going to take time.
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Post by agedhippie on Jan 8, 2018 8:26:56 GMT -5
I heartily agree. The US is easily the most profitable market and if we can retain it we should. The question for any buyer will be why Sanofi, with experience in the space, failed and the buyer believes they, without experience can do better. I cannot see anyone of any consequence being interested until Afrezza is a proven success at which point you may get a partner who picks it up to buy the revenue stream. respectfully disagree in a large way. Sny was selling and backed off. Mnkd has proven afrezza is a very promotionally sensitive drug, which works in spectacular fashion by the way. A partner will come on board at some point, likely soon. Here’s why. Mnkd Sales team is 7x smaller than a national sales team. Extrapolate existing sales to a national team. It would mean Breakeven and beyond very quickly. You cannot extrapolate sales teams like that. Mannkind has their sales teams in the best markets at the moment. It is the same problem USPS has - if you serve everywhere you lose money, if you serve a few key places you make money. Expand the sales teams and you get into diminishing returns. Mike knows what he is doing.
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