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Post by otherottawaguy on Jan 24, 2015 18:02:33 GMT -5
Original Email to Mannkind: On Jan 23, 2015, at 12:56 PM xxxxx wrote:
Mr Pheffer:
Is there anyway that you can clear up how many production lines are currently certified and producing product at Danbury?
We know there is at least one (would have been hard to meet the production quota for launch), just wondering about the other two that you have mentioned that are about 10% greater in capacity that were supposed to have been on line in 2015. Speculation is that they are not online yet followed by speculation that they are avail and that is how the quota was met early.
Nice to have heard back from you before Christmas in response to my phone call.
Sincerely, xxxxx
Response email was back with in 5 min (impressive response time):
On Friday, January 23, 2015 3:59 PM, "Pfeffer,Matt" <mpfeffer@mannkindcorp.com<mailto:mpfeffer@mannkindcorp.com>> wrote:
The two additional lines are in place but must go through a lengthy testing and validation process. Will likely take another couple of months. A good reason to build up healthy pre-launch inventory.
Matt
Sent from my iPhone
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Deleted
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Post by Deleted on Jan 24, 2015 18:18:50 GMT -5
Hopefully he clarifies if that testing and validation process has started and in progress or is yet to start.
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Post by xoxoxoxo on Jan 24, 2015 19:26:53 GMT -5
I'm just thinking about earnings now and all the costs
1) Costs of installing these 2 production lines
2) Marketing costs (hopefully??)
3) Cost of manufacturing a huge pre-launch inventory
4) R&D on new technosphere possibilities
5) Extra stock options for Diane Palumbo to convert/sell on the open market
From an accounting perspective. I believe items 2 and 3 are split 35/65%, and hopefully item 1 as well? Maybe this is why they wanted to defer those milestone payments/initial $150m?
My next question to Mr. Pheffer would be whether they'd need a 4th line to do R&D on other drug combos. I doubt they'd be able to use the production lines and I just don't know how much equipment is needed to develop other technosphere combos.
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Post by mrhaigs on Jan 24, 2015 20:44:39 GMT -5
You don't use a production line for R&D.
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Post by Deleted on Jan 24, 2015 21:04:54 GMT -5
The lines are long since bought and paid for. Il
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Post by otherottawaguy on Jan 24, 2015 21:16:06 GMT -5
As i understand it the new line run sbout 10M installed and take about 6 month to add.
These two lines sound like they are to be ready to roll at the end of Mar.
I will make a prediction that the capacity will be required.
OOG
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Post by Deleted on Jan 24, 2015 21:20:02 GMT -5
So this begs to question, what was the $50 mil for? The manuf milestones were split into 3 25 mil pieces. If one was hitting launch inventory, what was the other? It's clear that CMC and approval of line 2/3 would be the remaining manuf milestone.
Or did they get more than anticipated on launch inventory because it was early? I noticed in the lengthy 10Q that manuf milestones were redacted (of course) but the third one listed appears to be Scales of up to $50?
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Post by rockstarrick on Jan 24, 2015 21:32:52 GMT -5
The question I have.....There are 2 packaging and filling suites, each suite can hold up to 3 packaging and filling lines for, a total of 6 lines.
Is there 1 line per suite running, with two for each suite to be certified.??
That would make a little more sense, the plant holds 6 lines, at least that's what I get out of this.
From the press release on Torcon/Mannkind Danbury Plant.
New construction work involved the addition of 16,723 square metres to the plant. This phase of work involved installation of two fill and two packaging suites with associated support rooms. Each of these suites can accommodate three fill / packaging lines.
The Afrezza manufacturing facility required an investment of $163m. It was dedicated in September 2008.
In January 2010, the plant won two Facility of the Year Awards (FOYA), one for Process Innovation and another for Equipment Innovation. FOYA is sponsored by the International Society for Pharmaceutical Engineering (ISPE), INTERPHEX and Pharmaceutical Processing Magazine. It is given each year to honour and recognise the best of pharmaceutical manufacturing facilities in seven different categories. Less
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hawk1969
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Post by hawk1969 on Jan 24, 2015 21:42:59 GMT -5
I do not know about the three lines but your statement that manufacturing costs were to be split 35/65 is incorrect. According to my understanding, the prelaunch manufacturing inventory is to be reimbursed 100% by Sanofi.
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Post by Deleted on Jan 24, 2015 21:45:37 GMT -5
Not sure why this is so difficult to understand . Line 1 producing, line 2/3 being cmc'd. Estimate may online. That puts 2015 production capped at around 350,000 patients annualized
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Post by gwb on Jan 24, 2015 21:56:14 GMT -5
Not sure why this is so difficult to understand . Line 1 producing, line 2/3 being cmc'd. Estimate may online. That puts 2015 production capped at around 350,000 patients annualized It's great this so confusing , I understood these to be fill lines . The original line was to accommodate 170,000 ( Appox ) patients , these two " New " lines are 10 % greater in capacity so that brings you to 190,000 ( appox ) and when the 12 unit + are approved the patient capacity will be over 200,000 per line . So at three lines we should be over 500,000 patients per year . After all this time and reading so many different numbers from posts , I am confused . Where is Brentie ? He will have the quotes . |
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Post by Deleted on Jan 24, 2015 23:07:46 GMT -5
500k is the number but I'm prorating it for 2015 and delayed start of line 2/3
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Post by gwb on Jan 24, 2015 23:27:24 GMT -5
500k is the number but I'm prorating it for 2015 and delayed start of line 2/3 Fugacity , it's all good , we don't know the launch amount , people assume it's 50,000 , we don't know the line capacity at 3 shifts 24/7 and new unit sizes 12 , 16 . Al spoke of a new process with 32 unit cartridges that will be coming. At 350 thousand times $ 3,000.00 = Blockbuster . If we can get total sales close to that in the first year . Our money issues are long over. I know MNKD's net is 22.5 % after all + and - . |
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Post by spiro on Jan 24, 2015 23:29:50 GMT -5
Spiro just told me that if the launch goes as expected, lines 4, 5 and 6 might be operational by December 1. This could alter your calculations. But SNY will not release any details of these plans until they acquired at least 5% of MNKD's shares.
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Post by Deleted on Jan 25, 2015 7:47:55 GMT -5
500k is the number but I'm prorating it for 2015 and delayed start of line 2/3 Fugacity , it's all good , we don't know the launch amount , people assume it's 50,000 , we don't know the line capacity at 3 shifts 24/7 and new unit sizes 12 , 16 . Al spoke of a new process with 32 unit cartridges that will be coming. At 350 thousand times $ 3,000.00 = Blockbuster . If we can get total sales close to that in the first year . Our money issues are long over. I know MNKD's net is 22.5 % after all + and - . I took a stab at launch inventory in another thread. It doesn't take much math to know what they were required to make, but it's around 30,000,000 cartridges or 330,000 boxes, which is enough for about 25,000 patients annualized. When you calculate post launch production estimates with this, you end up close to 350,000 patients annualized. At $2000/each that's about $700mil rev in 2015 selling out |
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