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Post by ezrasfund on Mar 3, 2015 14:58:18 GMT -5
What Sanofi sold to Pfizer for $1.3 billion was just their 50% stake in Exubera. Pfizer already owned half. I am not sure whether Nektar retained any financial interest, but this valued Exubera at a minimum $2.6 billion. We won't know if they met their 10 year target for a few more years LOL. Only a fool would think a ten year projection could mean anything.
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Post by Deleted on Mar 3, 2015 18:02:53 GMT -5
This is the document that fills in a lot of the blanks. I'm currently reading the section that lists the diabetes drugs that Afrezza will be competing against. MannKind makes it crystal clear how much faster Afrezza is compared to competitors' drugs. I'm beginning to think that this 10-K could be a catalyst resulting in investment advisor upgrades. No joke. A number of questions are being answered in this document. Questions that investment advisors have been asking. Questions that investors have been asking. I have a feeling that I'm going to enjoy reading it. I might even have to change my avatar back to The Thinker. mn/others: Did you guys notice the table buried deep in the 10-K? Its a table of their contractual obligations going forward. Of particular interest to me was this: Open purchase order and supply commitments(1) Less than 1 yr: $ 39,135 with Note (1) meaning (1) The amounts included in open purchase order and supply commitments are subject to performance under the purchase order or contract by the supplier of the goods or services and do not become our obligation until such performance is rendered. The amount shown is principally for the purchase of materials for our clinical trials, the acquisition of manufacturing equipment, and commitments related to the expansion of our manufacturing plant. If I read into this, it would suggest MNKD is planning on spending $40mil in less than a year, and by inference from the note, that some/most is for expansion, assuming that materials for clinical trials is somewhat small. Lines cost about $10mil each, do they not? Of additional interest is that in the table it lists 1-3 yrs, 3-5 yrs, and > 5 yrs with those values being very small. Do they expect full expansion in less than a year?
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Post by Deleted on Mar 3, 2015 18:08:39 GMT -5
Another gem in the 10-K:
They plan to spend $28,260,000 on insulin in each year until 2019. I know we already kinda knew that, but this confirms the aggregate total with AMPH. How much insulin in kg is $28mil/yr?
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Post by mnholdem on Mar 3, 2015 20:15:34 GMT -5
That's the 2-4 billion cartridge question, isn't it!
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Post by savzak on Mar 4, 2015 9:22:02 GMT -5
From the 10-K: "We are currently operating a single filling line with the capacity to process 100-120 million cartridges per year, and have installed and preliminarily qualified two additional filling lines that will bring our annual fill/packing capacity to 300-360 million later this year. In addition, the facility includes expansion space to accommodate as many as 12 filling lines and other equipment, allowing production capacity to be increased based on the demand for AFREZZA over the next several years. Before the Connecticut facility reaches its maximum capacity, we and Sanofi expect to coordinate the construction and qualification of an additional manufacturing facility, which may be owned and operated by Sanofi."
Question: Does anyone know what "preliminarily qualified" means? Specifically, is any further qualification necessary before these lines can legally start producing?
If so, can anyone offer any details on when the final qualification is anticipated?
If not, then it would seem the only remaining obstacle to making the lines operational is SNY's/MNKD's decision to do so.
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Post by esstan2001 on Mar 4, 2015 9:38:33 GMT -5
preliminarily qualified-
they dry-ran, tested, and obtained satisfactory data per GMP / FDA guidelines in advance of having the FDA 'folks' show up and do it for real.
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Post by savzak on Mar 4, 2015 9:58:44 GMT -5
preliminarily qualified- they dry-ran, tested, and obtained satisfactory data per GMP / FDA guidelines in advance of having the FDA 'folks' show up and do it for real. Thank you. Is this something you know as fact or is this your opinion of what "preliminarily qualified" means? Also, any knowledge as to the time frame for the FDA inspection?
Thanks again.
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Post by esstan2001 on Mar 4, 2015 10:19:57 GMT -5
Hi Savak, no knowledge of timeframe. It is an FDA scheduling of the 'key person' issue.
No, I do not know exactly that this is the case; however from other bio / pharma investments I had been involved with, there were always FDA inspections and scoring as to how well GMP compliance was prior to any approval / drug launch. In wireless / telecom, we run pre-IOT (Inter-Operability Testing) before going in front of an agency to do real IOT which requires scheduling the time; you want to be sure you will pass. A failure can cost tremendously in terms of trying to get back into the queue. I am drawing from observations of other investments and analogies in my industry that involve gov't agencies. Sorry I can not provide you with concrete :-)
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Post by savzak on Mar 4, 2015 10:24:13 GMT -5
Not at all. Thank you for the insights. It's certainly be best explanation I've received thus far.
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Post by Chris-C on Mar 4, 2015 12:15:13 GMT -5
The 10K does not portray a company that seems skeptical about the demand for its lead product. Nor, do the agreements with SNY indicate that they have anything other than optimism given that they negotiated an opportunity to get into production.
This makes yesterday's bear attack much more understandable. Somebody knowledgeable may have read this carefully during the wee hours and decided that a downgrade was warranted. They didn't have time to create credible reasons for the negative sentiments, so they blamed slower than anticipated sales and regurgitated tired arguments about limited efficacy and high cost.
As I posted when Al Mann made Hakan CEO- I continue to believe that this action signaled that Mr. Mann is satisfied that the company is on track to realize the success he anticipated. Nothing in the 10K changes that opinion.
Chris C
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