|
|
Post by trenddiver on Aug 18, 2015 12:36:07 GMT -5
KC, It doesn't really matter to me what you believe, but go ahead and "shoot the messenger" just because you didnt like the message. Truth be told, I didn't like the message either and tossed it around for several days as whether I would share it with the board. And BTW, this person was not someone I just met. Like I said, he was a friend of a friend whom I knew had started and managed a hedge fund and when we started talking about biotech stocks, I mentioned that MNKD was one of my largest holdings. It was then that he told me that his HF had been short MNKD, owned puts, and as part of the discussion explained his reasons for his short position. Trend Trend, Are you the same "Trend" who's a much more obvious basher on another MNKD message board? If so, you're much more subtle in your bashing here. No. Haven't posted on any other MNKD boards in quite a while (almost a year). If you want to see my posts, check out my profile on this board. Trend |
|
|
|
Post by kc on Aug 18, 2015 12:52:42 GMT -5
Trend, Are you the same "Trend" who's a much more obvious basher on another MNKD message board? If so, you're much more subtle in your bashing here. No. Haven't posted on any other MNKD boards in quite a while (almost a year). If you want to see my posts, check out my profile on this board. Trend
Trend there is a Trend on the IHUB board who is ruthless and spreading FUD. I know you have been here a long time and I was not questioning your honesty. I just didn't like the comment. MY bad and I apologize.
|
|
|
|
Post by trenddiver on Aug 18, 2015 13:05:07 GMT -5
No. Haven't posted on any other MNKD boards in quite a while (almost a year). If you want to see my posts, check out my profile on this board. Trend
Trend there is a Trend on the IHUB board who is ruthless and spreading FUD. I know you have been here a long time and I was not questioning your honesty. I just didn't like the comment. MY bad and I apologize.
Apology accepted. |
|
|
|
Post by bradleysbest on Aug 18, 2015 14:27:50 GMT -5
Now that this is hashed out..... Can we get some damn good news that will make the share price go up???
|
|
Deleted
Deleted Member
Posts: 0
|
Post by Deleted on Aug 18, 2015 14:31:45 GMT -5
FYI - Harry posted this a bit ago. Looks like SNY by undertaking this is making a longer term commitment so to steal the heading of this thread, take it for what its worth. As others noted, if they were about to bail, they would not be doing this. Trend, not sure if you have a way of communicating with your HF contact but it would be interesting to hear their response to this. mnkd.proboards.com/thread/3295/afrezza-safety-pharmacokinetics-study-pediatricPS - as far as the shorts go, my guess is they got more and more excited after each CRL thinking they hit pay dirt. Obvious they didn't do much research on Al Mann. Decades and decades of me to products in the diabetes industry. Some nice innovation but the exception rather than the norm. Perhaps all the innovation was saved up to use in one product. If so, my bet is that Afrezza is the one. |
|
|
|
Post by tigiron on Aug 18, 2015 15:17:28 GMT -5
I cannot find my post with the link, but it's spelled out in the License and Collaboration Agreement that the initial upfront payment and all milestone payments are not refundable, even if the Agreement is discontinued. I think it was opc11 or colton_harden that started the rumor about needing to hold on to those payments because they would have to be returned if Sanofi were to walk. That was FUD. Not correct. But why MNKD canNOT book the milestone revenue? Other than amortization... |
|
|
|
Post by obamayoumama on Aug 18, 2015 16:00:43 GMT -5
I cannot find my post with the link, but it's spelled out in the License and Collaboration Agreement that the initial upfront payment and all milestone payments are not refundable, even if the Agreement is discontinued. I think it was opc11 or colton_harden that started the rumor about needing to hold on to those payments because they would have to be returned if Sanofi were to walk. That was FUD. Not correct. But why MNKD canNOT book the milestone revenue? Other than amortization... Their auditors have made a determination that MNKD can not book the milestone payments as profits until MNKD is able to show that MNKD will be able to show a profit at some point in the future. MNKD can still use the milestone payments as needed. Where those payments are on the balance sheet means little to nothing. |
|
|
|
Post by trenddiver on Aug 18, 2015 16:13:31 GMT -5
Here is the language from the Company's recent SEC filing. Essentially they are saying that the milestone payments represent a non refundable advance with certain future requirements and obligations to be performed by MNKD including the funding of 35% of the start up expenses. Since there is no way to measure the amount and duration of the startup
expenses (profitability) the cash received from the advance is reflected in some deferred income account which is shown on the Balance Sheet as a liability because of MNKD's obligations to perform under the collaboration agreement. At some point in the future if and when profitability occurs or becomes a certainty, some or all of the deferred income will be recorded as income. Just to be absolutely clear, under no circumstances are these Milestone Payments ever refundable to Sanofi.
7. Collaboration arrangement
Sanofi License Agreement and Sanofi Supply Agreement
On August 11, 2014, the Company and Sanofi entered into the Sanofi License Agreement, which became effective on September 23, 2014. Under the terms of the Sanofi License Agreement, the Company granted to Sanofi exclusive, worldwide licenses to certain of the Company’s patents, trademarks and know-how for the development and commercialization of AFREZZA. Under the terms of the Sanofi License Agreement, Sanofi has the exclusive right and responsibility to develop AFREZZA worldwide, subject to certain development activities that will be performed by the Company. Sanofi will also be obligated to use commercially reasonable efforts to file for, obtain and maintain marketing approvals for AFREZZA in certain major markets and countries. In addition, Sanofi will have exclusive, worldwide rights to commercialize AFREZZA and will be obligated to use commercially reasonable efforts to market, promote and commercialize AFREZZA in all countries in the world where regulatory approval for AFREZZA has been received. Under the Sanofi License Agreement, Sanofi paid the Company an up-front cash payment of $150.0 million in the third quarter of 2014 and a subsequent payment of $50.0 million in the first quarter of 2015 for the achievement of two manufacturing milestones as of December 31, 2014. If certain development, regulatory and sales milestones are achieved, the Company will also be eligible to receive up to $725.0 million in additional milestone payments, of which $25.0 million relates to a development milestone event, $50.0 million relates to the filing and completion of regulatory approvals and $650.0 million relates to the achievement of certain product sales milestones. In addition, worldwide profits and losses, which are determined based on the difference between the net sales of AFREZZA and the costs and expenses incurred by the Company and Sanofi that are specifically attributable or related to the development, improvement, regulatory filings, manufacturing, and commercialization of AFREZZA will be shared 65% by Sanofi and 35% by the Company. In accordance with the terms of the Sanofi License Agreement, profit and loss sharing commenced in the fourth quarter of 2014.
Pursuant to the terms of the Sanofi Supply Agreement, the Company will be the exclusive manufacturer and supplier of AFREZZA until the specified conditions are met, upon which a portion of the manufacturing activities may be assumed by Sanofi.
The Company analyzed the agreements entered into with Sanofi under the provisions of ASC 605, Revenue Recognition , to determine whether the consideration, or a portion thereof, could be recognized as revenue. ASC 605 provides that revenue is recognized when there is persuasive evidence that an arrangement exists, delivery has occurred or services have been rendered, the price is fixed or determinable and collection is reasonably assured. In addition, revenue arrangements with multiple elements are divided into separate units of accounting if certain criteria are met, including whether the delivered element has stand-alone value to the customer. When deliverables are separable, consideration received is allocated to the separate units of accounting based on the relative selling price of each deliverable and the appropriate revenue recognition principles are applied to each unit.
The assessment of multiple element arrangements requires judgment in order to determine the appropriate units of accounting and the points in time that, or periods over which, revenue should be recognized. Under the terms of the Sanofi License Agreement, Sanofi Supply Agreement and the Sanofi Loan Facility the Company determined that the arrangement contained significant deliverables including (i) licenses to develop and commercialize AFREZZA and to use the Company’s trademarks, (ii) development activities, and (iii) manufacture and supply services for AFREZZA. Due to the proprietary nature of the manufacturing services being provided by the Company, the Company determined that all of the significant deliverables should be combined into a single unit of accounting. The Company believes that the manufacturing services are proprietary due to the fact that since the late 1990’s, the Company has developed proprietary knowledge and patented equipment and tools that are used in the manufacturing process of AFREZZA. Due to the complexities of particle formulation and the specialized knowledge and equipment needed to handle the AFREZZA powder, neither Sanofi nor any third-party contract manufacturing organization currently possesses the capability of manufacturing AFREZZA.
In order for revenue to be recognized, the seller’s price to the buyer must be fixed and determinable. Given that as of June 30, 2015, the Company did not have the ability to estimate the amount of costs that would potentially be incurred under the loss share provision related to the Sanofi License Agreement and the Sanofi Supply Agreement, the Company believes this requirement for revenue recognition has not been met.
As such, the Company did not recognize any revenue pursuant to the Sanofi License Agreement or the Sanofi Supply Agreement for the three or six months ended June 30, 2015. The Company has recorded the $150.0 million up-front payment and $50.0 million from milestone payments as deferred payments from collaboration. In addition, as of June 30, 2015 the Company has recorded $13.4 million in AFREZZA product shipments to Sanofi as deferred product sales from collaboration and recorded $10.8 million as deferred product costs from collaboration. Deferred product costs represent the costs of product manufactured and shipped to Sanofi, not to exceed the amount of deferred product sales, for which recognition of revenue has been deferred. During the three months ended March 31, 2015 and June 30, 2015, the Company’s portion of the loss sharing was $12.4 million and $12.8 million, respectively, which resulted in the reclassification from current deferred payments from collaboration to Sanofi loan facility and loss share obligation.
|
|
|
|
Post by trenddiver on Aug 18, 2015 16:22:04 GMT -5
FYI - Harry posted this a bit ago. Looks like SNY by undertaking this is making a longer term commitment so to steal the heading of this thread, take it for what its worth. As others noted, if they were about to bail, they would not be doing this. Trend, not sure if you have a way of communicating with your HF contact but it would be interesting to hear their response to this. mnkd.proboards.com/thread/3295/afrezza-safety-pharmacokinetics-study-pediatricPS - as far as the shorts go, my guess is they got more and more excited after each CRL thinking they hit pay dirt. Obvious they didn't do much research on Al Mann. Decades and decades of me to products in the diabetes industry. Some nice innovation but the exception rather than the norm. Perhaps all the innovation was saved up to use in one product. If so, my bet is that Afrezza is the one. I forwarded the link on. I'll let you know what the reply is, if any. Trend
|
|
|
|
Post by petech on Aug 18, 2015 16:24:31 GMT -5
FYI - Harry posted this a bit ago. Looks like SNY by undertaking this is making a longer term commitment so to steal the heading of this thread, take it for what its worth. As others noted, if they were about to bail, they would not be doing this. Trend, not sure if you have a way of communicating with your HF contact but it would be interesting to hear their response to this. mnkd.proboards.com/thread/3295/afrezza-safety-pharmacokinetics-study-pediatricPS - as far as the shorts go, my guess is they got more and more excited after each CRL thinking they hit pay dirt. Obvious they didn't do much research on Al Mann. Decades and decades of me to products in the diabetes industry. Some nice innovation but the exception rather than the norm. Perhaps all the innovation was saved up to use in one product. If so, my bet is that Afrezza is the one. I forwarded the link on. I'll let you know what the reply is, if any. Trend
Could you also tell him to exclusively short from Fidelity? 16.5% is kind of a buzz kill when we were in the 20% for so long.  |
|
|
|
Post by cretin11 on Aug 18, 2015 16:35:18 GMT -5
FYI - Harry posted this a bit ago. Looks like SNY by undertaking this is making a longer term commitment so to steal the heading of this thread, take it for what its worth. As others noted, if they were about to bail, they would not be doing this. Trend, not sure if you have a way of communicating with your HF contact but it would be interesting to hear their response to this. mnkd.proboards.com/thread/3295/afrezza-safety-pharmacokinetics-study-pediatricPS - as far as the shorts go, my guess is they got more and more excited after each CRL thinking they hit pay dirt. Obvious they didn't do much research on Al Mann. Decades and decades of me to products in the diabetes industry. Some nice innovation but the exception rather than the norm. Perhaps all the innovation was saved up to use in one product. If so, my bet is that Afrezza is the one. I forwarded the link on. I'll let you know what the reply is, if any. Trend
Thanks Trend. Even if we don't like what your contact there is saying, it's still a valuable perspective for us to have (as others have pointed out). If indeed the short thesis is now based to some degree on Sanofi bailing in early 2016, then we have another hurdle identified just as before we had AdCom, approval, partnership, etc. And if this latest pediatrics study news is somehow persuasive to a heretofore HF short, that would be nice to know. Thanks again for sharing with us. |
|
|
|
Post by compound26 on Aug 18, 2015 17:29:27 GMT -5
|
|
|
|
Post by kc on Aug 18, 2015 17:45:19 GMT -5
I forwarded the link on. I'll let you know what the reply is, if any. Trend
Could you also tell him to exclusively short from Fidelity? 16.5% is kind of a buzz kill when we were in the 20% for so long. I liked it better when Fidelity was paying 30% |
|
|
|
Post by peppy on Aug 18, 2015 18:09:48 GMT -5
Quote: TRICARE covers AFREZZA at Tier 2 no restrictions.
Reply: Tricare (styled TRICARE), formerly known as the Civilian Health and Medical Program of the Uniformed Services (CHAMPUS), is a health care program of the United States Department of Defense Military Health System.[1] Tricare provides civilian health benefits for military personnel, military retirees, and their dependents, including some members of the Reserve Component. The Tricare program was managed by Tricare Management Activity (TMA) under the authority of the Assistant Secretary of Defense (Health Affairs). Tricare is the civilian care component of the Military Health System, although historically it also included health care delivered in the military medical treatment facilities.
On 1 October 2013 TMA disestablished and Tricare responsibility was transferred to the Defense Health Agency (DHA) which was established on the same day.[2]
|
|
|
|
Post by kball on Aug 18, 2015 18:58:44 GMT -5
Could you also tell him to exclusively short from Fidelity? 16.5% is kind of a buzz kill when we were in the 20% for so long. I liked it better when Fidelity was paying 30% As long as we're complaining...July started with the share price at 5.59. And ended the month at 4.48. A 20% decline. My interest payment was about 1/10 of that. Insomnia my friend and companion |
|
