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Post by daduke38 on May 17, 2015 8:03:54 GMT -5
We sure had a lot of good news come out last week. Is it just me, or is there starting to be a change of Sentiment? We seem to have other countries already showing an interest in Afrezza. Is it possible that new production is in the works outside the USA? I really don't see Danbury being used for any distribution outside the USA. Also, if someone could refresh my mind, who is responsible for payment of Production facilities outside the USA? There is no way MNKD could afford it at the pace SNY may need the product. I know this board isn't big on buyouts, but does anyone really see MNKD producing world wide? And if SNY is paying for the added production and probably running it, how long will they be willing to kick back 35% of profits?
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Post by tripoley on May 17, 2015 8:14:24 GMT -5
We sure had a lot of good news come out last week. Is it just me, or is there starting to be a change of Sentiment? We seem to have other countries already showing an interest in Afrezza. Is it possible that new production is in the works outside the USA? I really don't see Danbury being used for any distribution outside the USA. Also, if someone could refresh my mind, who is responsible for payment of Production facilities outside the USA? There is no way MNKD could afford it at the pace SNY may need the product. I know this board isn't big on buyouts, but does anyone really see MNKD producing world wide? And if SNY is paying for the added production and probably running it, how long will they be willing to kick back 35% of profits? I assume the cost for new facilities for production will be split 65/35 between SNY/MNKD. How much did they say a new line costs?
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Post by eddiemoy on May 17, 2015 8:14:29 GMT -5
shared cost between SNY and MNKD with same profit/loss split 65/35. current danbury plant can only handle up to 12 lines. new factories "may be owned and operated by Sanofi"
from their 10k
"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."
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Post by eddiemoy on May 17, 2015 8:15:47 GMT -5
oh, unlikely they are building another plant, they are USA focused!
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Post by daduke38 on May 17, 2015 8:50:00 GMT -5
oh, unlikely they are building another plant, they are USA focused!e ready Without a doubt Marketing is. But are they going to wait for approvals from countries that will Approve this in a heartbeat (Some will accept FDA approval) to have production ready to go? They don't need a new plant, just space for the lines. If SNY doesn't have thier facility Dept. looking ahead, I would be shocked. In fact, building a plant is a 12 to 18 month project, and that is just for the buildng. Add in time to install lines and equiment, you are looking at another 6-12 months. SNY is not gonna want to wait that long to have increased capacity. I have worked with quite a few facility projects for Bio firms, and they are all 2+ years ahead on needed space and equipment. JMO, but I think Afrezza is better than what SNY thought they were getting. Toujou alone will not make up for Lantus.
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Post by liane on May 17, 2015 8:54:42 GMT -5
Doesn't SNY own the old Exubera plant. Sorry, can't remember the details. If that's the case, wouldn't take as long to fit it out.
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Post by kball on May 17, 2015 9:00:07 GMT -5
Doesn't SNY own the old Exubera plant. Sorry, can't remember the details. If that's the case, wouldn't take as long to fit it out. I seem to remember reading about this also. Though not how far along/far away Sanofi might be in beginning operation. This isn't like APPLE farming out production to chinese companies I'd remind folks.
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Post by liane on May 17, 2015 9:03:19 GMT -5
It's in Germany, not China.
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Post by daduke38 on May 17, 2015 9:07:35 GMT -5
Doesn't SNY own the old Exubera plant. Sorry, can't remember the details. If that's the case, wouldn't take as long to fit it out. I am 99.9 % sure they do. That is why I stated new buildings might not be needed. Having said that, the old Exubera plant has been idle for some time, so it would need some work I am sure. Then you have the issues of "Is the plumbing, Electricity, and HVAC built to accomadate the Afrezza lines?" Just my opinion that they are already working on expanded capacity. Look how long it took to get lines 2 & 3 running and certified. Sorry, on a roll this AM!
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Post by xoxoxoxo on May 17, 2015 9:21:13 GMT -5
So basically Sanofi could pay for a new plant 100% and own it and would then be reimbursed for COGS the same way Mannkind currently provides product to the joint venture, right?
If they can get their costs down, that's great because it doesn't matter who produces Afrezza. It's a wash for us.. The only fear is not wanting it produces in China or someplace where they'll steal our intellectual property and start manufacturing counterfeit drugs.
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Post by Deleted on May 17, 2015 9:32:20 GMT -5
We sure had a lot of good news come out last week. Is it just me, or is there starting to be a change of Sentiment? We seem to have other countries already showing an interest in Afrezza. Is it possible that new production is in the works outside the USA? I really don't see Danbury being used for any distribution outside the USA. Also, if someone could refresh my mind, who is responsible for payment of Production facilities outside the USA? There is no way MNKD could afford it at the pace SNY may need the product. I know this board isn't big on buyouts, but does anyone really see MNKD producing world wide? And if SNY is paying for the added production and probably running it, how long will they be willing to kick back 35% of profits? The tide does seem to be turning Duke but keep in mind, what drives SP long term is top and bottom line growth. Weekly Rx count is a nice interim proxy between quarterly reports. Only other metric might be trying to track DTC when it begins and perhaps professional education programs pertaining to Afrezza but these can't be tracked / measured the same way. On the production issue, you and others have addressed. My comment would be in addition to staying ahead of the curve as you referenced, they also need to be able to build, store and rotate on a regular basis safety stock to account for unexpected events. Due to the nature of insulin, patients obviously cannot go without it as it is no aspirin. Rx manufacturers who have life preserving product have vast contingency plans for safety stock in case of supply interruptions so to your point, expanding Danbury alone I suspect does not adequately address this. On a slightly different note, I watched CNBC I believe Friday and they were talking 13F filings. They mentioned that Leonard Green had a stake over 5% in Bed Bath Beyond but had filed some type of privacy request so as not to disclose. Not sure about all the details or timeline but when I saw it I wondered perhaps if the redacted info from MNKD filing was along similar lines. As a shareholder, I would welcome a bidding war but if I were SNY putting up $$ to market Afrezza, I would want some mechanism in place to avoid a bidding war so maybe some type of predetermined methodology to value MNKD with first right of refusal to SNY. What I do not understand is how a publicly traded company would not be obligated to shareholders to seek the greatest valuation but SNY would likely say it was they who risked up front capital and the challenge of selling / marketing the product. I think by the end of the year we will get an idea of where things are headed.
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Post by kball on May 17, 2015 10:28:02 GMT -5
It's in Germany, not China. Yeah...I was talking about the relative ease of subcontracting out tech production (done largely in china) vs. manufacturing of inhaleable insulin wherever that happens to be.
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Post by Deleted on May 17, 2015 10:56:49 GMT -5
It's in Germany, not China. Yeah...I was talking about the relative ease of subcontracting out tech production (done largely in china) vs. manufacturing of inhaleable insulin wherever that happens to be. Ya so they can jack the IP and make counterfeits in india and Chinese sweat shops
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Post by brentie on May 17, 2015 11:30:34 GMT -5
Doesn't SNY own the old Exubera plant. Sorry, can't remember the details. If that's the case, wouldn't take as long to fit it out. I am 99.9 % sure they do. That is why I stated new buildings might not be needed. Having said that, the old Exubera plant has been idle for some time, so it would need some work I am sure. Then you have the issues of "Is the plumbing, Electricity, and HVAC built to accomadate the Afrezza lines?" Just my opinion that they are already working on expanded capacity. Look how long it took to get lines 2 & 3 running and certified. Sorry, on a roll this AM! Yeah, but the plant that Sanofi owns produced the insulin for Exubera. It didn't make the final product like the Danbury plant does. MannKind Closes Acquisition of Insulin Assets from Pfizer VALENCIA, Calif.--(BUSINESS WIRE)--Jun. 22, 2009-- MannKind Corporation (Nasdaq:MNKD) today announced that it has completed its acquisition from Pfizer Inc. (NYSE:PFE) of a quantity of bulk insulin and a license to manufacture bulk insulin for use in pulmonary delivery pursuant to an insulin sale and purchase agreement. Upon the closing, MannKind and Pfizer also entered into an agreement pursuant to which MannKind agreed to maintain and store the remainder of Pfizer’s bulk insulin inventory and acquired an option to purchase the remaining insulin, in whole or in part, at a specified price, to the extent that Pfizer has not otherwise disposed of or used the remaining insulin. The total purchase price for this transaction, including consideration payable to MannKind for its storage and maintenance obligations, was $3 million, which MannKind paid in cash. MannKind had also entered into a sale and purchase agreement with Pfizer relating to Pfizer’s insulin manufacturing facility in Frankfurt, Germany. MannKind’s rights and obligations under this latter agreement were subject to a right of first refusal in favor of Sanofi-Aventis. On June 8, 2009, Sanofi-Aventis exercised its right of first refusal, thereby releasing MannKind from any obligations under this agreement.
www.news.mannkindcorp.com/phoenix.zhtml?c=147953&p=irol-newsArticle&ID=1300930
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Post by jpg on May 17, 2015 11:53:08 GMT -5
I think we might be getting ahead of ourselves? It's not as if 1, 2 or 3 lines can't tale up the near and medium term demand (sadly!).
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