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Post by lakers on Oct 23, 2017 12:12:38 GMT -5
7. Expansion of Payor Coverage (CVS/Caremark? Mike C said they were ready to sign with a large PBM in Jan 18) ExpressScript, no PA, Aetna, Anthem and more in Jan 2018. But number one, our sales force was hired in February. We started with a small beta sales force last year, and we subsequently expanded them to a full-time MannKind sales force in February. And we started, February with about 70 FTEs, we since hired some Medical Liaisons and we’ve got a fully integrated sales team, I think right about 90ish sales reps today, and our insurance coverage continues to expand, so we have Express Scripts with no prior authorization, Aetna, Anthem and more to come. One Drop collaboration is something we announced in late May, and that’s something that we’re looking at around, how do you use coaching to get optimal outcomes? How you potentially think about a membership model to change the cash market? There’s $300 million in cash insulin sales in this country, where people are paying several hundred dollars a month just for their insulin. The next thing is around clinical trials. So the last time there was any trial done for this drug was probably back in 2012 subsequently getting ready for approval. Since then you’ve had people like Dexcom and One Drop and [indiscernible] all these new technologies coming into diabetes around coaching and virtual apps, and so we don’t have any data in that space. We started to invest data looking at dosing of this product and how you dose the drug, because we think that if you go back to the pivotal programs, the product was consistently underdosed. And so we passed our outcomes, but I believe if you really dose the product, if you look at some of our modeling data, we believe we can have potentially a superior insulin. Now, we’re trying to really get some of that data moving, so that we can really articulate what the product profile looks like versus other mealtime insulins. MannKind's (MNKD) CEO Michael Castagna on Cantor Fitzgerald Global Healthcare Conference (Transcript) $MNKD www.seekingalpha.com/article/4109298
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Post by lakers on Oct 22, 2017 14:26:39 GMT -5
MC has delivered the first one. What's next? www.healthline.com/diabetesmine/afrezza-updates-february-2017International Afrezza: MannKind says it's also eyeing international markets such as Brazil, Canada, Mexico, UAE, Australia, and even China. They're also exploring filing possibilities in the European Union. Most of that will be done through partners internationally, though some may remain MannKind-led launches worldwide. Could there be something like this? www.fiercepharma.com/r-d/china-s-wuzhou-says-it-will-take-10-stake-oral-insulin-specialist-oramed-for-52mChina's Guangxi Wuzhou Zhongheng Group disclosed that it intends to purchase a 10% stake in Israeli pharma company Oramed for $52 million, in return for exclusive Chinese distribution rights to its oral insulin following regulatory approval, according to a briefing from Reuters.
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Post by lakers on Oct 21, 2017 17:14:12 GMT -5
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Post by lakers on Oct 21, 2017 17:06:31 GMT -5
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Post by lakers on Oct 21, 2017 13:44:52 GMT -5
I think that EMA requirements which follow an application for marketing approval in Europe may be simply be too expensive for MannKind at this time. The EMA doesn't often accept FDA approval data as sufficient. That's correct. Note that the 2 studies conducted by Sny for the new label were conducted soly in Germany for a reason. Canada, Mexico are gimme with NAFTA stamped on their foreheads, OUTSULIN, A trademarked, new label, ready to go. Mnkd's strategy near term is targeting populous countries which accept FDA results. This helps address the plant fix cost which can support $2B sale. A: We continue to update on our international expansion at every opportunity as it represents a means of expanding Afrezza sales, one of two top priorities expressed by both Mike and Steve, the other being recapitalization. As Mike stated in August, we are still on track to file by the end of the year in Brazil, if not sooner. As you may surmise, with the recent approved label update, our partner, BIOMM, wanted to reflect the FDA's approval in its filing with ANVISA. The timelines with respect to other international opportunities vary based on regulatory requirements in each country and potential partnership discussions always seem to take longer than originally anticipated. We are currently targeting Canada, Mexico, India and China in the near term and, as you know, after following MNKD all these years, we would not make any announcements until there is a definitive partnership agreement in place. UAE has always been an area which Al felt passionate about. We continue to work with international regulatory experts to prioritize our expansion. Read more: mnkd.proboards.com/user/1882/recent#ixzz4wAZCwGQmInternational expansion is another opportunity. So we announced BIOMM in Brazil. That deal is moving forward. We have several other markets that are of interest to us that we’ll continue to work on. Those markets are important because of the volume. When you see the plant that we build, it was built to do over $2 billion in sales and $6 billion in cartridges a year. So that’s a fixed cost. Most companies of our size don’t always have that big of a plant ready to go, but this company was meant to be a multi-billion dollar company. And the part of it was meant to take off a little bit faster. But obviously, that didn’t happen so we’ve been readjusting our cost structure. But the international expansion will consume a lot of the volume of insulin in terms of just getting rid of some of the purchase commitments we have with [Indiscernible]. And as you think about the U.S., we’ll get a decent amount of volume here as well. But if you look at cost of pharmaceutical industry, whether we like it or not, the U.S. market is where most companies make their profit and get their growth. And so that’s our major focus and we’ll be opportunistic around some of the other international markets in terms of do we want them for MannKind or do we partner those out, and that’s something that we continue to work through. Read more: mnkd.proboards.com/user/1882/recent#ixzz4wAaGZbFe
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Post by lakers on Oct 21, 2017 2:54:12 GMT -5
Afrezza TV commercial launch, so we first launched the commercial on July through a small channel on Discovery called Discovery Health. That TV show was called REVERSED, it’s a celebrity named Charles Mattocks who filmed this Real Life Diabetes in 10 episodes. And that TV show is now getting picked up and COX Communications and that will be placed in about 16 million households starting in November, and we’ll also continue to have the presence in that expansion of that opportunity. A lot of people asked why we sponsored the show? Well, we didn’t think there was anything on TV focused on diabetes. And if you really watch, it highlights the trials and tribulations and what people go through every single day and had a nice uptake in every week they continue to increase their people watching. And so now cost communications has picked it up and they’re ongoing other discussions for season two. So we’re excited to be a partner with them, because there’s really a small pilot putting a lot of money in the grand scheme of things and that pilot is now starting to hit on some more traction. 9/25/17 MannKind's (MNKD) CEO Michael Castagna on Cantor Fitzgerald Global Healthcare Conference (Transcript) $MNKD www.seekingalpha.com/article/4109298
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Post by lakers on Oct 21, 2017 2:42:52 GMT -5
Q: Have you targeted any specific international markets? A: Last week we announced a partnership with Brazil. We are also looking at the Middle East — such as United Arab Emirates — as a key part of the world that, for cultural reasons, would really prefer an inhalable insulin over an injectable. India and China are two fantastic markets. There’s just a pandemic going on out there in the marketplace. India has 80 million people living with diabetes. This, unfortunately, is a 30- to 40-year disease. The developing countries are really setting themselves up for a significant cost burden in taking care of people in the future. Today, they are not seeing a lot of damage, but over the next 10 years they will see a lot of damage from not managing their sugars. When you see 80 million people in a country really heading for disaster, that’s going to have a significant consequence for society. m.newstimes.com/business/article/New-MannKind-CEO-Afrezza-global-markets-are-key-11208232.php
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Post by lakers on Oct 20, 2017 11:50:06 GMT -5
International expansion is another opportunity. So we announced BIOMM in Brazil. That deal is moving forward. We have several other markets that are of interest to us that we’ll continue to work on. Those markets are important because of the volume. When you see the plant that we build, it was built to do over $2 billion in sales and $6 billion in cartridges a year. So that’s a fixed cost. Most companies of our size don’t always have that big of a plant ready to go, but this company was meant to be a multi-billion dollar company. And the part of it was meant to take off a little bit faster. But obviously, that didn’t happen so we’ve been readjusting our cost structure. But the international expansion will consume a lot of the volume of insulin in terms of just getting rid of some of the purchase commitments we have with [Indiscernible]. And as you think about the U.S., we’ll get a decent amount of volume here as well. But if you look at cost of pharmaceutical industry, whether we like it or not, the U.S. market is where most companies make their profit and get their growth. And so that’s our major focus and we’ll be opportunistic around some of the other international markets in terms of do we want them for MannKind or do we partner those out, and that’s something that we continue to work through. seekingalpha.com/article/4105856-mannkinds-mnkd-ceo-michael-castagna-presents-rodman-and-renshaw-19th-annual-global-investment
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Post by lakers on Oct 19, 2017 0:32:27 GMT -5
Oct 2017 Sch 13F Creative Planning filed 10/17/17, Bank of Montreal filed 10/16/17, increased Mnkd holding significantly by 933%, 26,785.71%, respectively. whalewisdom.com/stock/mnkdChange "Quarter to View" field to Q3 2017 13F Filings Alternatively, www.nasdaq.com/symbol/mnkd/institutional-holdingsClick on "Date" to list filing in chronological order. Owner Name Date Shared Held Change (Shares) Change (%) Value (in 1,000s) AMERICAN FINANCIAL NETWORK ADVISORY SERVICES LLC 09/30/2017 8,000 8,000 New 38 ATWOOD & PALMER INC 09/30/2017 800 0 0.00 4 BANK OF MONTREAL /CAN/ 09/30/2017 150,560 150,000 26,785.71 715 CREATIVE PLANNING 09/30/2017 211,823 191,318 933.03 1,006
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Post by lakers on Oct 18, 2017 20:04:04 GMT -5
3:04 PM 10/18/2017 - MT Newswires 03:04 PM EDT, 10/18/2017 (MT Newswires) -- The European Patent Office on Wednesday granted MannKind (MNKD) its patent for dry powder inhalers, cartridges for dry powder inhalers and a system for rapid drug delivery to the pulmonary tract, including dry powders comprising active agents for the treatment of disease, including diabetes and obesity, according to the patent office annoucement. Still, MannKind shares were down more than 9% at $4.32 in late trade. The stock hit a 52-week high of $6.96 early this month, but has since faltered following its 10.2 million shares sale at $6 apiece to raise $61 million.Price: 4.31, Change: -0.45, Percent Change: -9.37
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Post by lakers on Oct 18, 2017 16:49:05 GMT -5
www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022472Orig1s011ltr.pdfFood and Drug Administration Silver Spring MD 20993 NDA 022472/S-011
SUPPLEMENT APPROVALMannKind Corporation Attention: Robyn Walsh, M.S. Senior Manager, Regulatory Affairs One Casper Street Danbury, CT 06810 Dear Ms. Walsh: Please refer to your Supplemental New Drug Application (sNDA) dated September 22, 2016, received November 30, 2016, and your amendments, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act (FDCA) for Afrezza (insulin human) inhalation powder. This Prior Approval supplemental new drug application proposes to amend the Afrezzaprescribing information (PI) with information supported by the results of study PDY14324entitled, “A randomized, controlled, 6-treatment, 6-sequence, 6-period, cross-over dose responsestudy of 3 single doses of Afrezza inhaled Technosphere Insulin and of 3 single doses of SCInsulin Lispro in patients with diabetes mellitus Type 1 using the euglycemic clamp technique,”[Locations Germany Investigational Site Number 276001 Neuss, Germany, 41460 Sponsors and Collaborators Mannkind Corporation Investigators Study Director: Clinical Sciences & Operations Sanofi clinicaltrials.gov/ct2/show/NCT02470637?term=mannkind&sfpd_s=01%2F01%2F2015&rank=3Last Update Posted: April 13, 2017] and study PDY14329 entitled, “An open-label, 2 replicate single dose euglycemic glucose-clamptrial to characterize PK and PD within-subject variability of a single dose of Afrezza inhaledTechnosphere Insulin in patients with diabetes mellitus type 1 (T1DM).” In addition, it alsoproposes to update the PI to comply with the Pregnancy and Lactation Labeling Rule (PLLR).
[Locations Germany Investigational Site Number 276001 Mainz, Germany, 55116 Sponsors and Collaborators Mannkind Corporation Investigators Study Director: Clinical Sciences & Operations Sanofi clinicaltrials.gov/ct2/show/NCT02485327?term=mannkind&sfpd_s=01%2F01%2F2015&rank=2Last Update Posted: March 15, 2017] ......................................................................... PROMOTIONAL MATERIALS
You may request advisory comments on proposed introductory advertising and promotional
labeling. To do so, submit the following, in triplicate, (1) a cover letter requesting advisory
comments, (2) the proposed materials in draft or mock-up form with annotated references, and
(3) the package insert(s) to:OPDP Regulatory Project Manager Food and Drug Administration Center for Drug Evaluation and Research Office of Prescription Drug Promotion (OPDP) 5901-B Ammendale Road Beltsville, MD 20705-1266 Alternatively, you may submit a request for advisory comments electronically in eCTD format. For more information about submitting promotional materials in eCTD format, see the draft Guidance for Industry (available at: www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM443702.pdf ). You must submit final promotional materials and package insert(s), accompanied by a Form FDA 2253, at the time of initial dissemination or publication [21 CFR 314.81(b)(3)(i)]. Form FDA 2253 is available at www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM083570.pdf. Information and Instructions for completing the form can be found at www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM375154.pdf. For more information about submission of promotional materials to the Office of Prescription Drug Promotion (OPDP), see www.fda.gov/AboutFDA/CentersOffices/CDER/ucm090142.htm. If you have any questions, call Michael G. White, Ph.D., Regulatory Project Manager, at (240) 402-6149. Sincerely, {See appended electronic signature page} Jean-Marc Guettier, M.D. Director Division of Metabolism and Endocrinology Products Office of Drug Evaluation II Center for Drug Evaluation and Research ENCLOSURES: Content of Labeling Carton and Container Labeling (previously approved on February 17, 2016) REMS (previously approved on April 20, 2015) JEAN-MARC P GUETTIER 09/29/2017
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Post by lakers on Oct 18, 2017 12:29:33 GMT -5
Nate is right. If you think pps will be $100 eventually, buying at $5, or $4 makes no discernible difference. It's hard to time the bottom. Often times, when you try that, you would miss the big run up. Buying in small increments or long term call like 2020 $10 makes sense. I have no doubt, with sufficient resources whether alone or with other fully committed entities, A will be a blockbuster. So will Tresprostinil and some TS pipelines. We are in the very early innings.
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Post by lakers on Oct 18, 2017 11:29:24 GMT -5
$1 is highly unlikely. Nate has been uncanny. Nate said fair value of MNKD is in the "20 to 30 dollar range," but that it could drop to $3.50 before rising to 9 or 10 dollars. He advises buying small lots on a regular basis. He also said that there's a "real possibility" of a buyout by a big pharma company. Read more: mnkd.proboards.com/thread/887/analyst-comments-thread?page=45#ixzz4vsUIcp3F
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Post by lakers on Oct 18, 2017 9:29:57 GMT -5
All these are public, previously known info, presented in a cogent format (FAQ) per IR.
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Post by lakers on Oct 18, 2017 8:55:29 GMT -5
10/17/17
Q: Mike C alluded to international expansion many times. Besides the upcoming filing in Brazil by Biomm, what are other expansions? UAE, Mexico, Canada? The later two and U.S. Are members of NAFTA, having no tariff, low cost of shipping thereby making Afrezza 25% cheaper in those countries. What are we waiting for?
Oman is newly added also on the expansion map. Is it safe to say any expansion in UAE will include Oman, Saudi Arabia?
A: We continue to update on our international expansion at every opportunity as it represents a means of expanding Afrezza sales, one of two top priorities expressed by both Mike and Steve, the other being recapitalization. As Mike stated in August, we are still on track to file by the end of the year in Brazil, if not sooner. As you may surmise, with the recent approved label update, our partner, BIOMM, wanted to reflect the FDA's approval in its filing with ANVISA. The timelines with respect to other international opportunities vary based on regulatory requirements in each country and potential partnership discussions always seem to take longer than originally anticipated. We are currently targeting Canada, Mexico, India and China in the near term and, as you know, after following MNKD all these years, we would not make any announcements until there is a definitive partnership agreement in place. UAE has always been an area which Al felt passionate about. We continue to work with international regulatory experts to prioritize our expansion.
Q: When is the next ER?
Please know that we are in our quiet period prior to our upcoming earnings call to be scheduled by or prior to the mandated 10-Q filing date of 11/9/17. As you may know, there is coordination required with executive calendars (Mike and Steve have been extremely busy on our recap solutions as disclosed a few times this quarter), the auditors, Deloitte, and our own financial close calendar given the other transactions that have diverted attention ($61M direct placement offering). As our standard practice, we will announce our earnings call at least a week prior to.
Q: Who is the new 10M share owner? That's more than 5%. Don't they need to file Sch 13 D within 10 days of 10/13/17? Maxim mentioned it was a fundamental health care group. A: Please refer to our 8-K filing related to the direct placement offering settled on Friday, 10/13/17. The investors were not disclosed and should there be a Sch 13 requirement, it is incumbent on the investor to comply.
Q: What are the new payors that will cover Afrezza as tier 2, no PA, no STEP, for 2018? A: We continue to make progress on the payer access front and anticipate improvements given the recent FDA approved label change. I anticipate Mike will update on payer access. I’m not aware that the label change moved Afrezza to tier 2, but let me follow up with our Market Access executive.
Q: When does Mnkd publish STAT result? By which media channel? A: STAT is an independent, investigator-led study. Accordingly, MNKD does not manage the study. We believe final patient visits and information will be collected over the coming weeks and then analyzed. We anticipate that Dr. Garg will share top-line results with us as soon as available with an expectation that study results will be presented in 2018. I trust you understand that we are not able to give guidance on expectations or study outcomes at this time. Q: Mike promised to share more info on the RLS partnership. So far there was none. What's going on there? A: For the same reasons you have inquired about the RLS collaboration, please know that it has been internally discussed as well. We continue to make progress with RLS and the original scope of our work to trigger the milestone payments.
Q: Does Mnkd plan to partner for inhaled Tresprostinil or go alone? A: As Mike has disclosed, we anticipate filing a pre-IND for Trespostinil and have not focused on partnering this initial step as we currently have the resources to do so internally, hopefully attracting the appropriate partner to take it to the next step, if needed.
Q: When will Mnkd finish training the sale force on the new label?
A: We quickly mobilized sales training and collateral upon receiving FDA’s approval of the label change. The entire sales force was pulled from the field, east coast in the latter part of the week after receiving approval and the west coast contingency in the early part of the following week. This week represents the first full week the entire sales force is in their respective territories.
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