|
Post by compound26 on Aug 6, 2018 10:18:07 GMT -5
BD @liane liane mnholdem mannmade ashiwi otherottawaguy spiro Can we make some changes to the board? This board is supposedly a board for the longs. However, increasingly, there are shorts on this board posting all kinds of materials, while pretending to be longs. I am fine with any shorts posting here, if they disclose their position as being short. However, it is very disingenuous for them to pretend to be longs or making comments like they are the most altruistic people in the world with their sole interest being protecting us longs. Is there a way to add a checkbox to indicate whether one is long, short, or have no position, before one can posting any comment? I think this can help and while at the same time does not add much burden for anyone who wants to post here. Also this is pretty common in other places like SA and other forums. Although this will not prevent shorts from cheating, at least this serves as a record of something and hopefully will help people see how disingenuous their posts are. For reference, stocktwits has a choice of bullish or bearish where you can choose before you posting anything. But I still prefer long, short, or have no position as I believe action speaks louder than words. And I would prefer that choice to be mandatory for posting anything here. To a less degree, I think to indicate whether one is long, short, or have no position, on one's profile is also very helpful. Perhaps we can also make that a required box that anyone registering here as a member must check. I noticed that we already have the sentiment checkbox showing that. Perhaps we can make this a required checkbox that any member must make a selection and such selection is always included in the profile shown below one's avatar.
|
|
|
Post by compound26 on Aug 5, 2018 14:25:42 GMT -5
Joey, can’t agree more. Judging by the posts, there are many saints here who are just concerned about us clueless little longs. They have no positions in MNKD and they spend thousand of hours worrying about us being “hurt” by the “incompetent” management. By my count, 8 of 10 of the world’s most altruistic persons are actually active contributors of this board. They are right here. The other two I can think of are AF and SO. Or probably a few others on SA and MF.
|
|
|
Post by compound26 on Jul 27, 2018 10:49:33 GMT -5
Additional cooperation between Bourne Partners and The Carlyle Group: Bourne Partners, The Carlyle Group and Industry Veterans Launch Millicent Pharma with Femring Acquisition May 21, 2018 bourne-partners.com/news/bourne-partners-the-carlyle-group-and-industry-veterans-launch-millicent-pharma-with-femring-acquisition/Charlotte, NC – May 21, 2018 – The Carlyle Group (“Carlyle”, NASDAQ: CG), a global alternative asset manager, and Bourne Partners (“Bourne”), a financial services firm focused in healthcare, along with pharma veterans Dr. John King, Roger Boissonneault and Geoffrey Elliot, have jointly launched Millicent Pharma. Millicent Pharma, the culmination of Phoenix Therapeutics (“Phoenix” the global pharmaceutical platform created by Carlyle and Bourne in 2015), seeks to build a global end-to-end pharmaceutical company through acquisition and the development of acquired pharmaceutical products. Femring, a vaginal ring treatment for menopausal women, was acquired from Allergan (NYSE: AGN) and serves as the first acquisition by Millicent Pharma. Founder and CEO of Bourne Partners, Banks Bourne commented, “When we formed our Phoenix partnership with Carlyle we knew we would be able to source a compelling team and other partnerships. Our 20+ year relationship with John and Roger represented an outstanding opportunity for Phoenix. We couldn’t think of a better team to fulfill Phoenix’s mission and strategy.”Dr. King will serve as Chairman of Millicent Pharma, Mr. Boissonneault as Chief Executive Officer (CEO) and Mr. Elliott as Chief Financial Officer (CFO). Prior to Millicent Pharma, Dr. King, Mr. Boissonneault and Mr. Elliott took Warner Chilcott (NYSE: WCRX) private (in 2005) and then took it public again in 2006, leading to its subsequent sale to Actavis in 2013 ($9 billion). WCRX was a global pharmaceutical company specializing in women’s health, gastroenterology, urology, and dermatology. At Warner Chilcott and its predecessor companies, Dr. King served as Non-Executive Chairman, Executive Chairman, and CEO, Mr. Boissonneault as CEO, and Mr. Elliott as CFO. Several former Warner Chilcott senior executives who have proven track records in the pharmaceutical industry are also joining the Millicent Pharma leadership team. Bourne Partners Strategic Capital (”BPSC”) and Carlyle are investors in Millicent.
|
|
|
Post by compound26 on Jul 27, 2018 10:32:20 GMT -5
I have not seen "exclusive" anywhere. So this may be just another "distribution avenue". It all counts though. It may make logistics better and easier to sales forces and/or medics around the world. I am optimistic that the next corp meeting will provide details. wmdhunt agree with your observation. Here are a few of my observations on this: a. this distribution arrangement probably is not an exclusive distribution arrangement, as wmdhunt noted above. Note the language "The agreement names Tanner as a distributor of Afrezza® outside of the United States in regions the product is not yet registered." b. Further to the observation under item a. above, I would assume this arrangement is in addition to whatever partnership/ self-filing that Mannkind is working on (Europe, Canada, Mexico, China, Middle East), etc., as noted by Mike in previous conference calls/presentations. Matt’s post on this probably is what the two parties are thinking of (i.e., where Mannkind has not signed a distribution agreement or filed for approval itself, Tanner Pharmacy will have the rights to distribute Afrezza to the customers there). c. Tanner Pharmacy/Bourne Partner probably is not as niche or small as some would think. See a few relevant reports below. 1. The Carlyle Group and Bourne Partners Form Phoenix Therapeutics to Build Global Pharma Company NEW YORK, NY and CHARLOTTE, NC – Global alternative asset manager The Carlyle Group (NASDAQ: CG) announced today that it has formed a joint venture with Bourne Partners, a healthcare-focused investor, operator and investment banking firm, to build a global pharmaceutical platform. This new venture, known as Phoenix Therapeutics, will be owned by Carlyle Partners VI, a $13 billion U.S. buyout fund, with a minority investment from Bourne Partners. Leveraging the financial resources and experience of Carlyle and Bourne, Phoenix Therapeutics will look to operate a pharmaceutical platform built through acquisitions. Phoenix Therapeutics will consider a range of acquisitions, including product and asset acquisitions, corporate acquisitions and carve-outs. www.carlyle.com/media-room/news-release-archive/carlyle-group-and-bourne-partners-form-phoenix-therapeutics-build 2. Partner Therapeutics (PTx) Acquires Leukine® from Sanofi www.prnewswire.com/news-releases/partner-therapeutics-ptx-acquires-leukine-from-sanofi-300591625.htmlTanner Pharma Group Signs a Distribution Agreement for Partner Therapeutics’ Product, Leukine® www.tannerpharma.com/tanner-pharma-group-signs-distribution-agreement-partner-therapeutics-product-leukine/Since quarterly conference call is only a few days away, let’s see what additional details Mannkind will provide regarding this distribution arrangement.
|
|
|
Post by compound26 on Jul 25, 2018 15:54:20 GMT -5
Also note that since this technology was purchased by Lily in 2015, presumably such purchase was okay-ed by none other than our current CMO, Dr. Kendall. Dr Kendall must did some home work on dry power + inhalation delivery technology and market at that time. And he must have foreseen a pretty bright future in dry power + inhalation delivery technology and market for him to okay the purchase. So, he already had part of his home work done long before he took the offer from Mannkind in Feb. 2018.
|
|
|
Post by compound26 on Jul 25, 2018 15:37:36 GMT -5
babaoriley , I will soon break your record of 28 times by listening to the Mannkind corp. post ADA meeting presentations a couple of times every day. I don't know if I believe the entire story either....
|
|
|
Post by compound26 on Jul 25, 2018 10:28:43 GMT -5
I have a very good friend who is a leading diabetes doc in his area and he says Satish is a global Rock Star in diabetes and was a big coup for the SAB. What is SAB?
|
|
|
Post by compound26 on Jul 24, 2018 18:55:26 GMT -5
This is so similar in concept to Afrezza. Note that it is also in dry power.
"You'll just stick the tube into a nostril and press the bottom, making the dry powder glucagon shoot into your nose where it's absorbed into the system. It's kind of like Flonase spray, except it's dry and not a mist."
|
|
|
Post by compound26 on Jul 23, 2018 22:36:29 GMT -5
The Ad campaign started on June 25, 2018 as Mike stated on the last presentation (held on June 27, 2018) that the Ad campaign started on that past Monday.
|
|
|
Post by compound26 on Jul 19, 2018 15:04:29 GMT -5
How did DXCM compensate the loss and meeting the quarterly expenses that long? Did they have enough $ ? ( By dilution or by debt ?) If you have done so much digging, I am sure you must have an idea on the same. I think the answer to this question is a great example of how successful biotech/med devices companies can make it. It also highlights that while no one necessarily wants dilution, it is a significant part of most of these stories and ultimate shareholder success.
To approx match time frames on Jan 1, 2009 DXCM had: (using quick numbers from Bloomberg - open to corrections)
29.8M outstanding shares $2.76 stock price 82.2M market cap
Starting in Jan 2009 through May 2011, DXCM roughly doubled their number of outstanding shares in 4 secondary offerings to raise money to fund operations.
As they started to prove their product and demonstrate growing revenues they were able to more easily tap the debt and convertible debt markets instead of having to go the secondary offering route. This stilled called for them to issue shares to help with interest payments and principal repayments, but it lessened the dilution effect. From these and other operations they issued about another 28M to 29M.
So now on 7/19/2018 DXCM has: 88M outstanding shares $102.7 stock price 9,047M market cap
So if you owned equity shares in 2008 you got diluted to an ownership stake of roughly a 1/3 of where you started. BUT... you still made about 37 times on your investment.
- one disclaimer - I didn't do a deep dive in DXCM to verify all the numbers from Bloomberg nor did I go through the detail of every dilution event. As stated above I'm open to corrections, but I think these are the basics.
Very informative! I was thinking about digging up some information on that, but now that you posted that, I have what I need to know. From my perspective, as long as Mannkind is ultimately successful, I do not mind Mike using up all of the 280 million shares as authorized. 280 million shares time $25 equals $7 billion, which is still lower than the current market cap of Dexcom. And if we get a market cap same as Dexcom today ($9 billion), that will be $32 at $280 million shares outstanding. I am also good with that.
|
|
|
Post by compound26 on Jul 19, 2018 11:52:37 GMT -5
How did DXCM compensate the loss and meeting the quarterly expenses that long? Did they have enough $ ? ( By dilution or by debt ?) If you have done so much digging, I am sure you must have an idea on the same. No, I do not have an answer to that question.
|
|
|
Post by compound26 on Jul 19, 2018 11:30:25 GMT -5
To put things in perspective, Dexcom first received FDA approval for its first generation CGM in 2006 and it did not earn any profit until this year (2018). It took 12 years for Dexcom to earn any profit. Mannkind received approval for Afrezza in 2014. Can Mannkind be profitable in 12 years after approval of Afrezza (i.e., by 2026)? I have full confidence Mike, Dave and the gang will beat that timeline handsomely. [Dexcom did $40 million sales in 2011, 5 years after the approval of its first CGM. It appears Mannkind will be doing about $40-50 million sales in 2018, 4 years after the approval of Afrezza. ] Since 2008, DexCom's annual sales have increased from less than $10 million to $718.5 million in 2017 -- a compounded annual growth of nearly 57%.
[Compound loves to see compounded growth. ] www.fool.com/investing/2018/06/13/dexcom-stock-history.aspxDexcom's history of innovation Until 2003, DexCom's research focused primarily on developing implantable sensors that could remain in the body for an extended time. But in 2004, growing concern that the company would face challenges gaining approval for a long-term implant solution that was more invasive and costly than traditional finger sticks, led to the development of short-term, temporary sensors that can be attached to the skin. In 2005, DexCom raised $56.4 million in an IPO on the Nasdaq to fund clinical trials of its short- and long-term system. The short-term sensor and CGM solution -- the STS continuous glucose monitoring (CGM) system -- won FDA approval in 2006 after trials demonstrated patients spent less time outside a normal healthy blood sugar range while using it.
The long-term implant solution, however, was halted after the company "evaluated several months of data from feasibility studies" and determined the product "didn't warrant investing in a large pivotal trial." In short, creating a reliable long-term device that would pass muster with regulators, payers, and patients was too difficult a challenge to overcome, particularly given the successful launch of the short-term sensor solution, which was a revolutionary advance in its own right. The short-term STS system used tiny wire-like sensors that were inserted by the patient just under the skin that could be worn for three days. Data collected by these sensors was reported wirelessly to the STS receiver, where it was charted and displayed in a graph to patients. To help patients know when their blood glucose levels were too high or too low, the STS system also included a feature that triggered alerts. The company's second-generation product, the seven-day STS CGM system, got the FDA's nod in 2007. That system increased the time sensors could be worn by diabetics from three to seven days and it included a feature that allowed patients to download their glucose level data to a computer for review. These early systems provided revolutionary insight to patients but didn't begin to gain widespread adoption until 2008, when results from a Juvenile Diabetes Research Foundation trial were unveiled. In its 322-person trial, CGMs significantly improved glucose control without hypoglycemia. The study was important because it reduced worry that the use of CGM's could cause patients to take too much insulin. Thanks in part to a growing body of evidence supporting the use of CGMs, DexCom's sales began to accelerate. In 2008, sales climbed 76% to $8.1 million and by 2011, sales were topping $40 million. The rapid run-up in sales allowed DexCom to plow more money into research and development, and that spending led to the development of its next generation of CGMs, the G-series. The company's first G-series CGM was the G4 Platinum, which won FDA approval in 2012. The G4 was smaller than the STS systems preceding it, and it improved hypoglycemic accuracy by 30%. The improvement in accuracy is important because CGM's don't measure glucose levels through the bloodstream. Instead, they do so through the interstitium, a fluid-filled space just under the skin. Because CGM sensors are inserted into the interstitium, the CGM's software contains code that deduces actual blood sugar levels from the sensor readings at points in time. Absent greater accuracy, patients were still at risk of taking too much insulin, which can cause hypoglycemia. The G4 also offered a longer transmission range between its sensors and the receiver and a more user-friendly color LCD display than previous devices. In 2015, DexCom followed up the G4 with the G5. The G5 allowed patients to see real-time data on either a DexCom receiver or on any compatible device, including smartphones, via an app. The G5 also included an option to securely share real-time data with a caregiver, such as a parent, and it provided access to a cloud-based repository where data could be stored for review. Importantly, the G5 was the first DexCom CGM to do away with the need to confirm CGM readings with finger sticks prior to taking insulin. Although finger sticks were still necessary every 12 hours to calibrate the system, the advance significantly reduced the burden of finger sticks on patients. Ongoing technological advances, such as the G4 and G5, alongside growing acceptance of CGMs generally, has been a boon to the company's top line. Since 2008, DexCom's annual sales have increased from less than $10 million to $718.5 million in 2017 -- a compounded annual growth of nearly 57%.
|
|
|
Post by compound26 on Jul 18, 2018 16:28:20 GMT -5
Agree. But I think it is more likely via a bulk shipment to Brazil as revenue recognition is tied to shipment of Afrezza. I think Mike can probably expect a shipment of around $5-6 million to Brazil if needed to enable Mannkind to make guidance. This is similar to what Mannkind did in terms of meeting the guidance of 2nd half of 2017. I think this is all fine as long as it is within the accounting rules. To me, the more important part is the upward trend and momentum. As long as we keep growing, we will do fine. Additionally, as sales grow and international expansion kicks in, the margin will keep improving, which will another driver for meeting the guidance. Think about it, had Mannkind management started doing what Mike and Dave are doing (STAT trials, international partnership, dusting off old trials, getting publications, fixing package, better understanding of dosing and titration, etc.) from 2015, then we would be in much better position right now. Had Mannkind management raised a couple of hundred of millions in 2014/2015, we would also in much better position. However, all in all, we are in a much better position than 2016 and 2017 at this moment. Brazil $ in 2018? 🙏 Yes, Mike stated that they expect the approval to be granted in the fourth quarter of 2018 and the launch in the beginning of 2019. So a shipment of Afrezza towards the end of 2018 for preparation of launch in the first quarter of 2019 is possible, especially if there is a need to get some revenue for the fourth quarter of 2018.
|
|
|
Post by compound26 on Jul 18, 2018 15:31:18 GMT -5
|
|
|
Post by compound26 on Jul 18, 2018 14:40:44 GMT -5
My "take"on the stat study has been determined in part on the actual results, which by and large seem actually pretty good, but also on what I consider to be the promise of what it has shown us and for which Dr. K is integral in the storytelling and explanation both because he "sees" it and because he has the gravitas to tell it/sell it to other experts in diabetes. When the stat study first came out I was expecting more positive comments from people. I am not a true science person so I was a bit confused at what I thought was the underwhelming response to the study, espcially given a few people on this board whom I respect for their science background that did not see the merits as very positive.. But upon further study and hearing more comments it is now my personal beleif that the stat study results are quite positive and lay the groundwork for the new mannkind and the new conversation about Afrezza that goes with it. That conversation imho is as follows: 1. Stat study showed how Afrezza can accomplish exactly, if not better control, as what an RAA can accomplish in less time with less hypos. To me, this in and of itself is good news. You can debate whether or not the numbers are statiscally relevant. Does it make Afrezza superior? I beleive it does. 2. Now the promise... what the study did not do is show how Afrezza can work to keep better control and TIR at significanntly lower levels of fasting BG which would require in many cases higher does of basal insulin and/or adjusments to prandial dosing. But as we know from the many anecdotal posters on social media, they are getting non diabetic numbers in the 5's and even more of them in the low to mid 6's for Hba1c's using Afrezza by targeting lower fasting BG at anywhere from 120 to 140. So why didn't the stat study show this as a goal? because imho it could not as a first of its kind study with a comparison to RAA's as its basis, since doing so would require dosing that most docs will not do with traditional RAA insulins as it would drive pwd into more severe hypos. (The stat study targeted 160 for fasting BG.) A separate study targeting lower BG will likely have to be done under more direct management if a comparison is done or with Afrezza only. THIS is the NEW story that could not be told now without the stat study... Remember that the ADA recently raised the acceptable Hba1c level to 8 from 7 or so because it has been too hard to get pwd to the lower levels without hypos and compliance is difficult with all that it entails for a T1. Afrezza changes all of this. Just think if you can now get pwd to a range of 5.5 to 6.5 with the same or less hypos... You don't think this would have to be the new SOC? And this is what Dr. likely meant when stating that Afrezza should be the SOC. Now again I do not have diabetes and I am not a science person so someone with a better understanding may be able to correct me if I have mispoken and hope they will but what imho I beleive is the true value of the stat study is the conversation Dr. K and the reps can now have with other docs that they had no basis for prior to the stat study... After listening to Dr Kendall's presentation to the investors yesterday, I now can clearly see that the STAT trial results are very significant. For anyone interested, please listen to the presentation, especially starting from about 1 hour into the presentation where Dr. Kendall discussed the details about the STAT trial. Here is the link to the replay of the presentation. lifesci.rampard.com/20180627/index.jsp#Based on Dr. Kendall’s presentation, here are my thoughts: 1. For the dosing compliant group, if you look at the charts included in the slides shown during presentation, the BG level of Afrezza group vs the RAA group at 1 hour after meal is roughly 145 vs 185. You can draw your own conclusion whether that is significant or not or whether Afrezza is superior on that front. 2. The above obviously superior result is achieved while the Afrezza arm of patients are clearly under-dosing themselves. Dr. Kendall explained that, for the trail purpose, the dosing is set to be 1 to 1, i.e., if a patient used to take 1 unit of RAA, he is taking 1 unit of Afrezza for the trial. Jeremy H. Pettus, MD has commented that, “ based on clinical experience, 4 units of Afrezza is roughly equivalent to 2.5 units of SC insulin. [see slide 77 of this Medscape Education presentation]. That observation is line with many Afrezza users’ experience who shared their experience on social media. Based on the above, if properly dosed, I am pretty certain the BG level of Afrezza group vs the RAA group at 1 hour after meal will be even more impressive than 145 vs 185 as achieved by the STAT trial. 125 vs 185 will certainly be an attainable target here as there is little hypo concern with Afrezza when taken at a relatively high BG level. 3. The 12% improvement in range in time is also very significant improvement. To bring that data point into context, Dr. Kendall noted that the 12% improvement in range in time with Afrezza is basically the same improvement that CGMs achieved when CGMs first got FDA approval. And Dr. Edelman is stating CMGs is now standard of care. 4. And in my personal opinion there are many other reasons why the STAT results could be even better if better trial protocols are used. You can read Sam’s article on this particular subject: How come Afrezza is WAY better now than on the Trials?5. Dr. Kendall further noted that over the entire history of insulin development, no new insulin actually has clearly out-performed competition within same class. Afrezza is the only exception based on the STAT trial data. Listened to the presentation a couple of more times (I probably have listened to it a dozen times all together). A few additionally observations: a. You can really feel Dave’s excitement and confidence. E.g., where he says his CMO job will be one of the easiest job (giving the data he already possess). b. Dave noted every time he looked at the STAT trial result data, he is getting more excited. Afrezza is providing improvement in four areas at the same time, 1. Using more insulin, 2. better BG level, 3, better Time In Range, and 4, few Hypos. No prior generation of insulin can provide improvement in all these areas at the same time. c. Dave noted that he does not see any competition to Afreza within next 15 years. d. Mike noted that they have been working to get the necessary data together so that they have a complete package to present to the doctors (while at the same time making sure that they are in compliance with FDA requirements) and they finally have such complete package of data by this ADA meeting to show what this drug can do with proper titration. e. Steve noted that when he provided samples to T1s and get them to try them, 80-90% would like to get a prescription. f. Dave noted that they recently hired a very experienced diabetes regulatory consultant and are working/planning (?) on a few very short term label-enabling studies with respect to PK and safety data (if I recall correctly). g. Mike and Dave’s goal is to “ let it be known and let it be fully known” (regarding increasing the awareness of Afreza) h. Mike and Dave now seem to have a firm grasp on the correct dosage and titration of Afrezza (note that Dave commented that they are increasingly aware that an injectable unit does not equal to an inhalable unit and that the same user may need to use 1.5 to 2.0 times of inhalable units to replace one injectable unit). i. At one point, Dave referred to Afrezza as ultra-rapid-acting insulin, though he immediately noted that FDA currently has not created a separate class for Afrezza.
|
|