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Post by Deleted on Jan 8, 2015 13:38:14 GMT -5
baba, What was the name (symbol) of the biotech you cited earlier with a new type of antibiotic? ( I'm developing a distinct masochistic tendency in my old age.) Thanks.
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Post by babaoriley on Jan 8, 2015 14:24:38 GMT -5
baba, What was the name (symbol) of the biotech you cited earlier with a new type of antibiotic? ( I'm developing a distinct masochistic tendency in my old age.) Thanks. CFRX, avo, good luck, I own just a few shares.
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Post by cusop on Jan 8, 2015 14:30:34 GMT -5
cusop, I don't think there's much cannibalization to be had. Sanofi is a small player in the prandial market. 2014 9 month sales of Apidra were 240 M euro. Extrapolating to 1 full year and converting to dollars gives ~ $380 M in sales. By contrast, Novolog for Q4 2013 did $344 M in sales, or ~ $1.4 B extrapolated to 1 full year. Sanofi is a much bigger player in the basal market with Lantus (hopefully soon to be replaced with Toujeo). If anything, Afrezza complements vs cannibalizes. Thanks Liane, I read somewhere that this was the case, I just don't keep up to date as well as a lot of the members of the board, but based in your answer then, Sanofi and MNKD would be even more discreet as they know that there introduction price is going to capture the early adopter market and the competition will want to snuff these sales out as it will slow down the overall uptake in the market. I wonder if part to the strategy is to offer both forms of medication as a complete solution. This would be of even greater concern for the competition as it would eat into market share. I think as we get closer to market introduction these strategies will appear the sales force interacts with care givers and the insurance companies. If Sanofi's strategy is provide a complete solution using both products this could well mean that everyone is underestimating the market impact of Afrezza.. Well I hope so.. as many of you do
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Post by alcc on Jan 8, 2015 14:37:32 GMT -5
baba, What was the name (symbol) of the biotech you cited earlier with a new type of antibiotic? ( I'm developing a distinct masochistic tendency in my old age.) Thanks. Novobiotic? Private company.
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Post by Deleted on Jan 8, 2015 14:42:41 GMT -5
It was a public company due to complete some testing this month.
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Post by jdn1129 on Jan 9, 2015 16:58:08 GMT -5
I', not sure if this has been seem or posted before. Read slide#8. This would have me believe the $50m milestone payment just received on 1/8/15 may possibly have been for approval for the EU and Japan? I sure hope this is the case...would be amazing if this was in the works during complete silence. afresa.blogspot.ch/Attachment Deleted
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Post by brentie on Jan 9, 2015 17:13:04 GMT -5
JDN, that would be nice but I think it's too early for that. I seem to recall them saying that they wouldn't be doing anything with the European submission until after the US launch. Also this is what they said on the last earnings call.
Josh Schimmer - Piper Jaffray
Thanks for taking the questions. First one for Hakan, if you could clarify the supply and manufacturing milestones that you expect, the timing and then the amount. And then for Matt, just because it’s so important for modeling the Company want to push a little deeper on the percent of R&D in the quarter that was for manufacturing and what kind of decline we should expect? I’m sure that is information that you have fairly handy. And earliest in the ballpark, are we talking 50% of the expenses for the quarter, more or less? Thanks very much.
Hakan Edstrom
In regards to the supply milestones, having started commercial production, we feel at this point in time but that certainly will have to be reduced by the JAC that we have met the performance targets and parameters that was important for the first of the two milestones. So my expectation is that as soon as the JAC is coming together for the first or the second joint meeting that will be an item for review and that’s happening in a few weeks.
Josh Schimmer - Piper Jaffray
And the dollar amount for those milestones?
Hakan Edstrom
The first is $25 million.
Josh Schimmer - Piper Jaffray
Great.
Matthew Pfeffer
I told you we announced that there are three milestones that we’re potentially CMC related and they’re 25 each. And with that so I guess my answer, we’re not sure it would be helpful, I can certainly breakdown between manufacturing and clinical – because I think that might even be misleading because the clinical sort of expenses and R&D are coming down rapidly but it’s not bottomed out yet by any means. Certainly manufacturing is about two-third of that total. I think that percentage will increase but it’s not going to completely go away. We do expect to have some cost associated with future application, the product that it will still be ours and other things that will be done to faster development and for the products even then to the Sanofi agreement, that will still remain our cost, they’ll be chargeable to the collaboration but not currently reimbursable.
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Post by jdn1129 on Jan 9, 2015 17:22:44 GMT -5
Brentie,
Thanks for the clarification. You're probably right. I was not aware that the production milestone payments would have been broken down 25/25/25 for a total of $75mm. This now makes sense to why $50mm was just collected. Most likely production related, given our current stage in the launch process.
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Post by liane on Jan 9, 2015 17:38:07 GMT -5
The approval process in the EU is very long (something like a year) and also very transparent. We would know if they had filed, and each step along the way. So I don't think we are suddenly approved in the EU.
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Post by biotec on Jan 9, 2015 18:37:28 GMT -5
Dec 27, 2014 at 4:48pmrak5555 said: I would be very careful about any positions that depend on news being shared prior to Q4 of next year. Clearly SNY does not want the competition to know anything about Afrezza, and that will be especially true regarding sales. The partner accounting from MNKD's side of things is so convoluted, it will take several Q's before we can start to figure it out. The partner agreement from SNY's side of things will be hidden behind the veil of immateriality for several Qs. Our best bet will be if one of the script tracking services will sell that information to investors (something I learned about w/ KOSP). As an example of how little we know, would anyone be surprised to learn that Europe has been filed, or MNKD has added new lines, or MNKD has broken ground on a European factory, or the 12 Unit cartridge has been approved, or the FDA has approved new trials to expand the label, or ...................................... ? SEC regulations every Q must show sales, Europe file,FDA must show cartridge approvel, new trials.etc! And if any of the above has happend it would of got out the day it happend. Why would SNY or MNKD keep quiet about Europe file? That info would only help the company and shareholders! Sanofi has zero incentive to share anything (including European filing) with the public (and it's competitors). Only Mannkind shareholders could maybe benefit somewhat and at the cost of sharing important info with competitors I would not be surprised if future Aftezza sales were more important to Sanofi then keeping a few anxious and jittery MNKD shareholders happy... JPG Yes liane, I said the same before. Its easy to find and public info. But I got jumped all over!
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Post by mnholdem on Jan 9, 2015 22:50:12 GMT -5
There's also some redacted stuff in the 10-Q that is kind of interesting: "(e) Launch Conditions. Recognizing that Sanofi's obligations to launch Product are ultimately determined by application of a standard of Commercially Reasonable Efforts, the Licensors acknowledge that Sanofi does not intend to launch the Product before and until achievement or completion of [...***...] Milestone." Id say its likely this was that Milestone. I believe that the launch, itself, will be the first sales milestone and result in yet another Sanofi payment. I suspect that the $50M production milestone payment will not be deferred like the $150M upfront payment was. Am I the only one a little excited about this upcoming CC? Several months ago, Matt said we may see some MAJOR changes occur in MannKind financials, starting with the 4th Quarter. Actually, "curious" is a better description. I gave up being cautiously optimistic for my New Year's resolution (chuckle).
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Post by Deleted on Jan 9, 2015 23:13:32 GMT -5
I'm of the belief that the milestones are all slated to be paid out before the redacted term ends in 2017. I also feel that the majority of them are attainable (80%+).
I agree with the cc, mn.... One of these days Id like to go thru all the conference and 10-q documentation because everytime I look there's more stuff I find. I glanced at one of them the other day where Matt talked about their total cash burn dropping 2/3rds of what it was per quarter with afrezza manufacturing moving to cogs ...
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Post by noonen on Jan 10, 2015 0:22:08 GMT -5
I'm of the belief that the milestones are all slated to be paid out before the redacted term ends in 2017. I also feel that the majority of them are attainable (80%+). I agree with the cc, mn.... One of these days Id like to go thru all the conference and 10-q documentation because everytime I look there's more stuff I find. I glanced at one of them the other day where Matt talked about their total cash burn dropping 2/3rds of what it was per quarter with afrezza manufacturing moving to cogs ... Fugacity, do you remember which quarterly cc transcript you saw that about the cash burn dropping 2/3? That's awesome.
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Post by Deleted on Jan 10, 2015 6:45:17 GMT -5
I can't remember if it was a 10-q cc or another conference they've attended since but I remember reading it somewhere
Edit: Ok it was the 3rd quarter Q&a. He expects 2/3rds of the r&d expenses to land in cogs. In the 3Q, r&d was roughly 19 mil, so based on that it should drop to 7mil going forward.
As for G&a, that was also $20 mil (total cash draw was $36mil), but almost half of it was in professional feels dealing with the licensing agreement. With salaries and stock based compensation (gotta keep padumbo full on shares) in the $10mil/quarter range G&A should drop from 19 mil to 10 mil going forward.
That would bring total cash drain from the $36mil it was in 3Q down to $17 mil in subsequent quarters. Put another way, the $200mil in milestones should provide enough funding for 10 more quarters of cash burn, keeping them cash positive until 1Q 17. Obviously, they should earn more milestones over that time (read: should reach most of them by then). This also assumes they don't dump cash into something else (convertible note, debt payback, etc)
With only $17 mil in expenses per quarter, I'd expect them to show positive EPS by 1Q with modest afrezza launch sales
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Post by noonen on Jan 10, 2015 13:20:19 GMT -5
nice thanks for that, I took a peek back at that transcript as well.
i'm not really looking fwd to seeing what the 2015 stock option plan looks like, but whatever. they are driving this thing, so keep em motivated. maybe they'll try to lock them up a little longer or something.
what a sweet little signal it would be if they paid off that convertible later this year. don't think it's going to happen (and Pfeffer said it is not very likely in that q3 transcript) but that would really make me smile.
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