Toujeo is vitally important for Sanofi. More important than Afrezza. I know that probably does not play well here, but it is the truth. If Toujeo is approved in Q1, like Sanofi thinks, it will launch in Q2 or Q3. That gives Afrezza a one to two quarter window to shine before Toujeo starts to pull away bandwidth from the sales force. The timing of the Afrezza launch matters for more reason than one.
Very nice post. Actually, I was thinking the same thing. I don't know of any new drug that is listed as preferred right off the bat, but I also don't know of any new drugs on the "not covered" list. NC is for brand with generic available, brand where several good substitutes are available in generic form or for brand with very low ongoing volume. Not sure about the copay tho. It does vary. I don't think $10/month extra would be a big deal to the vast majority of users. Your point of resistance would probably be closer to $30/month.
FWIW, I don't think the bear case is cancer, because we won't know that for five years or so. The bear case is manufacturing costs being too high to allow for a robust promotional effort. The company has a good idea of what the costs are but won't say because it could tip off the competition about potential promotional spend. I hope they open up about costs a quarter or two post launch.
First Endos, then GPs, then the consumer. The only consumer outreach near term is likely to be social media and PR. This is going to be a garden variety launch, and Afrezza is going to have to be vetted by the medical community just like every other new drug. Its not a bad thing, its just that some of you have unrealistic expectations.
Any Endo response you get from this board would automatically be biased.
FWIW, my wife is a doc, and she does occasionally change meds pts who are doing well if they ask. The average pt is too complacent to do that, but a small minority will, and most docs will say yes as long as there are no lung issues. Medicine is a business, and you need to keep the customer happy unless there is a good reason not to. I don't expect this kind of thing to generate much in the way of sales, but it might actually bring a few docs on board. A knowledgable pt asking about a new drug makes an impression on a good doc.
I really like your idea about placing demos around. Not sure how that would work with the FDA rules tho. Maybe they would need to have disclaimers on the thing LOL. Personally, I'm not looking for a big ad campaign right away. The first efforts will likely be targeted to specialists to get credibility and to make sure the drug is only being given to patients who fit the profile. Once enough people are on the drug to make sure there are no nasty surprises, the next target will probably be PCPs and then finally the general public. Big companies tend to be risk averse. Having said that, there are going to be PCPs who Rx it and patients who ask for it right off the bat.
Yep. Terry has an RE background, but if you look at CapEx spend. Well ...
FWIW, I don't think Terry and his crew are crooked, and with Terry's background I think their proved number is probably pretty solid. That makes the stock look interesting on an NAV basis.
Still haven't bought tho. These guys have dropped the ball time after time. Nobody trusts them, and nobody credible will recommend them even if they start doing better. They have an activist shareholder now but that won't fix execution. They are already cutting capex (ie destroying less money with the drill bit). For the shareholders to get something, the company would have to be sold. Who would buy? Whoever did would inherit the sh^tty ops and fixing it wouldn't be easy or quick. Terry might be forced out, but you still have the same issue.
If there is money to be made here, its not easy money. That said, I'd love to see the company turn around. Good luck to you guys who own it.
I hear Terry is a nice guy. Don't really feel good about cheering for him to leave. Even if he does, the CEO doesn't do everything. Bad execution usually goes deep in an organization. How about the President and his son the IR chief? Are they any good? How about the VP of Land? The VP of Drilling? I don't know where the problems are and neither does the market.
Why do you think the Senior Director of pt Marketing for Afrezza reports to the Toujeo commercial lead? Google it.
None smokers can get squamous-cell carcinoma too. Its just a little less common, although lung cancer in non smokers is uncommon in-and-of-itself.
The Edinburgh Lung Cancer Group registered 3070 new patients with lung cancer in the five years 1981-5 from a catchment population of 950,000. ...
All histological cell types were present. More non-smokers had adenocarcinoma than smokers (42% v 13%) and fewer had squamous cell carcinoma (32% v 49%) or small cell carcinoma (15% v 24%). Lung cancer in lifelong non-smokers is uncommon and the diagnosis should therefore always be questioned.
I really don't think two non smokers getting cancer out of maybe 4,000 test subjects tells us much. For all the testing, we won't know until large numbers of people have been inhaling for a few years.
Before Toujeo is launched (if it is approved), SNY's diabetes sales force has no other new products to talk about. So, from a sales call standpoint to Endos, Afrezza should get plenty of bandwidth. I don't expect any mass media direct to consumer ads, but I don't recall that happening with any new product launch. Other than that, Afrezza should have all the usual tchotchkies, brouchures and coupons.
Just over the past two years ...
Got caught short on EF take away capacity.
Gulf Coast wells decline greater than forecast.
Higher costs from EF impact PV-10.
I could probably find more things if I bothered to look. My point is that no one trusts management. If you are long on valuation, fine. If you know people there and you have evidence that things are actually improving, fine. Do your thing dude. I have no position, long or short. Would get long if I was convinced that things had changed or the stock got even more cheap. In the meantime ...
Not sure if anybody needs the inventory right now. With prices down, most players will spend their money drilling PUDs not doing buyouts. PE shops or MLPs could be a possible JV partner for some SFY properties, but I don't think anybody would want SFY to be the operator. The other alternative would be to go raise equity or do converts, not good for existing shareholders and a pretty tough sell in this market with this management team. The BTUs might be there in the ground, but money is tight and the market is in the tank. Creditors need to be paid and things could get pretty ugly.
I can't think of a single new drug that ever went on a PBM's formulary with a preferred status. That comes later. Initial coverage will almost certainly be branded-non preferred. Does that status even require a contract?
Why would they want to tell competitors the launch date? Doubt we get any info about the launch what-so-ever. The point of the presentation is to tell their investors what MNKD investors already know. If they have a new CEO by then, it would be good to have him/her reaffirm their commitment to afrezza. Not that I think anybody in their right mind believes that the product would be dropped. Just sit tight.
Seems like we should be able to put together a good estimate of manufacturing costs. Al seemed to imply that the insulin itself was significant ... investigating a new process that would use less insulin and therefore save money. I know that MNKD had a contract with Oragnon to buy bulk insulin, and I seem to remember someone here talking about how much that insulin would be worth if turned into Afrezza, but I can't find out how much was actually bought. Anybody know? Most of the rest should just be labor and overhead, right?
SI bothers me too. This isn't retail, and the big boys have access to info we do not. If I had to guess about the short thesis, they think
1. Its Exubra.
2. Even if it isn't, it uses too much insulin and margins will be bad.
I don't think its Exhubra, but I do worry about margins. Not sure what bulk insulin costs. Not sure what other material costs there are. We can estimate overhead based on current depreciation, but its not enough to make me comfortable. Would really love to hear from others on this one.
It was thirty days around the horn
The captain says it's thirty-five more
The moon looks mean the crew ain't staying
There's gonna be some blood
Is what they're all saying
It's a shakedown cruise
And I was just another tool
There ain't no easy way out
They're gonna shake you 'til you shout
They treat you like a dog
But you're only human
You miss your home Lord,
You miss that woman
The captain laughs he says,
"You boys want some sex?"
You can squeeze the sails,
You can lick the decks
It was a shakedown cruise
I guess I just was born to lose
They tell you life is going cheap
I got myself in pretty deep
Star light lost in the night
Drift away and it feels all right
Star light alone in the night
Drift away and it feels all right
I guess it feels all right
The fever's hot, the winds are blowin' cold
The captain's crazy eye puts the fear in your soul
I heard somebody cryin' "Lord let this end
You know I'll never go to sea again"
It was a shakedown cruise
And now we're sendin' out the news
There ain't no victory at sea unless it's mutiny
Now if I don't get off alive
It's just as well I'll be waking up in heaven
'Cause I've been through hell on this shakedown cruise
They call it a shakedown cruise
Shakedown, shakedown cruise
Shakedown, shake it up and move
Shakedown, shakin' in my shoes
Afrezza will start at tier 3 on everybodys formulary. That's SOP. You are right that it won't be a first line treatment for type 2s, Metformin comes first. Plenty of pts need more. I can't understand why anybody would need preapproval from insurance if Afrezza were priced like a pen. Having imaginary friends is a sign of schizophrenia, not diabetes. You sre on the wrong board.