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Post by lakers on Apr 2, 2017 12:58:14 GMT -5
Better Transparency on 4/1/17 April Fools' Day. I applaud IR's working overtime till 9:28 PM PST.
Matt said Mnkd would file IND for inhaled epinephrine in 1Q17. Is that going to happen soon?
Given our pre-IND meeting on December 6, 2016 and the ongoing discussions with the FDA regarding their requirements, we anticipate the clinical development plan and regulatory pathway, in addition to an inhalation toxicology study will take us into the summer of 2017 with an IND potentially before year end. This is all predicated on the FDA's acceptance of our regulatory strategy. As soon as we have definitive agreement with the FDA and get closer to IND submission, we will certainly update.
Matt said Mnkd would focus on finding partner for inhaled epinephrine. Any progress ?
Given our current financial runway, we have limited hires in areas which obviously translate immediately to Afrezza sales. Accordingly, Business Development has been one of those areas which we know we need to resource. We also know that potential partners, similar to our stockholders, want to see progress/results. We anticipate as we move further along the regulatory path with the FDA that we will attract the attention of an epi partner.
Matt said Mnkd is working on Afrezza international expansion. This should entail partners. What are the immediate target countries? Any update? When can the partners start to sell Afrezza?
Our international expansion focuses on those countries which have a less prolonged regulatory pathway given our US FDA approval. We are preparing filings for Brazil, Canada, Mexico, Australia, MENA, and the UAE. We are also evaluating EMA and other regions. Understandably, there are many parties who are waiting to see if Afrezza is adopted by the US and will be around. There are also many parties who want to be the first to introduce Afrezza in their regions. While there are ongoing discussions, our corporate policy is not to announce any material developments until there is definitive progress (translated to legally bounded agreements).
Mnkd would run out of cash this July. How will Mnkd plan to raise cash without diluting shareholders?
As Matt stated on 3/16/17, subsequent to the settlement with Sanofi, our cash balance didn't require an immediate need for funding. We are, obviously, continuing discussions with our current noteholders and other financing opportunities we have been approached with. Matt continues to focus on non-dilutive opportunities, if possible.
The TRX last week was 258. It stuck in the 200 range for over 6 mos. What's are the sale impediments? What is the plan to rectify that?
This week's TRX was slightly down at 256 (-1%), however, our TRx quantities increased 19% from last week (cartridges fulfilled)! We are confident we are on the right track with our new nurse programs (improving education and awareness), better payor coverage and the clinical programs kicking off, we will see these initiatives will make Afrezza known to physicians and patients, who (other than our stockholders) are who we need to engage with. I believe, as well, that our direct to consumer campaigns will address education, awareness, adoption and adherence.
Any update on RLS?
We continue to serve our obligations under the collaboration agreement with RLS. I can only speak to the fact that I see RLS in our office and lab space. Should we have any material update, we would announce via press release.
Matt said Mnkd would file IND for inhaled Tresprostinil this May. Is it still on track?
I will need to follow up on Monday regarding our development program, specifically Trepostinal.
When is the Annual shareholders meeting?
This year's Annual Meeting will be held in Danbury on 5/18/17. You should receive a notice shortly after our scheduled mailing date of 4/7/17.
When will pediatric Afrezza trial start?
As our CMO disclosed on 3/16, we are reviewing our ped protocol (originally agreed to by our former partner, Sanofi) with an eye to balance cost versus obtaining results to allow us to make Afrezza available sooner to our all-important pediatric population. We are inundated with inquiries from peds patients (or rightly so, their parents) who seek our inhaled solution.
Any update on label change?
I can obtain an update on Monday from our CMO. We have a PDUFA date in September 2017 based on our December 2016 submission (this is standard). It has been said that the FDA may take until that date to contact us.
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Post by goyocafe on Apr 2, 2017 13:12:34 GMT -5
Same answers as last quarter. Would like to see something other than "we're working on it".
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Post by madog365 on Apr 2, 2017 18:23:29 GMT -5
Thanks for the updates Lakers.
It concerns me that the entire company is focused on Afrezza sales in the US and still can't seem to improve the sales to a respectable level.Also i don't understand how long it takes to prepare filings in the other countries, we've been hearing the same song and dance since they got Afrezza back and not one filing has been completed in a year. Sales is out there selling afrezza but what the hell are the rest of the company's employees doing on a daily basis, that includes Matt who as CEO should be much more publicly visible (not just 1 conference call and 1 investor conference a quarter)
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Post by slugworth008 on Apr 2, 2017 18:27:38 GMT -5
Thanks for the updates Lakers. It concerns me that the entire company is focused on Afrezza sales in the US and still can't seem to improve the sales to a respectable level.Also i don't understand how long it takes to prepare filings in the other countries, we've been hearing the same song and dance since they got Afrezza back and not one filing has been completed in a year. Sales is out there selling afrezza but what the hell are the rest of the company's employees doing on a daily basis, that includes Matt who as CEO should be much more publicly visible (not just 1 conference call and 1 investor conference a quarter) Bottom line is Matt is not a CEO - He's taken on the role out of necessity and I suppose if he quit finding a replacement may be a bit challenging at this point. Then again what the heck do I know. I'm still holding and hoping the Afrezza train actually gets fricking moving. I would love to see us get to a point where the company could do a split and give us some shares back. Geez was that my outside voice?  ? |
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Post by orlon on Apr 3, 2017 11:06:54 GMT -5
I posted on their Facebook last week calling for the resignations of the Board of Directors, and a search for a new management team. Like whizzing in the wind though. I'm not sure how such a learned, accomplished and highly educated group on the BOD cannot come up some reasonable ideas. Just what do they do at their quarterly board meetings? How much longer can we listen to Matt P et al continue saying the same thing every quarter? I'm sure Al Mann is turning in his grave when he sees what incompetence or neglect has done to his company. BTW, isn't Matt P on the BOD of EYES?
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Post by agedhippie on Apr 3, 2017 11:16:55 GMT -5
I posted on their Facebook last week calling for the resignations of the Board of Directors, and a search for a new management team. Like whizzing in the wind though. I'm not sure how such a learned, accomplished and highly educated group on the BOD cannot come up some reasonable ideas. Just what do they do at their quarterly board meetings? How much longer can we listen to Matt P et al continue saying the same thing every quarter? I'm sure Al Mann is turning in his grave when he sees what incompetence or neglect has done to his company. BTW, isn't Matt P on the BOD of EYES? If you don't like the management I would advise selling because it isn't going to change because they don't have the time or the money for that. The bets are placed and the wheel is spinning. |
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Post by lakers on Apr 7, 2017 11:41:05 GMT -5
Follow-ups 5:09P PST Thurs 4/6/17.
As for Treprostinil, we are making progress with this pipeline product and I believe we may have already scheduled a pre-IND meeting with the FDA at the end of June.
The PDUFA date for our label change submission still remains in September 2017. We don’t anticipate the FDA will accelerate their review.
With the February relaunch and re-engaging of key opinion leaders and high prescribing physicians (in our desire to understand the hurdles to adoption and adherence), we have revised study protocols to provide us with the necessary clinical data to supplement the PI. This includes our titration and time-in-range studies. With these revised protocols, we are doing site selection and other clinical study start up activities.
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Post by lakers on May 1, 2017 16:32:15 GMT -5
MannKind Corporation to Hold 2017 First Quarter Financial Results Conference Call on May 10, 2017 investors.mannkindcorp.com/releasedetail.cfm?ReleaseID=1023513VALENCIA, Calif., April 28, 2017 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq:MNKD) (TASE:MNKD) will release its 2017 first quarter financial results on Wednesday, May 10, 2017 and its management will host a conference call to discuss the first quarter financial results and other Company developments at 5:00 PM (Eastern Time) on May 10, 2017. Presenting from the Company will be its Chief Executive Officer, Matthew J. Pfeffer and other members of senior management. To view and listen to the earnings call webcast, visit the Company's website at www.mannkindcorp.com and click on the "Q1 2017 MannKind Earnings Conference Call" link in the Webcast section of News & Events. To participate in the live call by telephone, please dial (888) 771-4371 or (847) 585-4405 and use the participant passcode: 44096372. A telephone replay of the call will be accessible for approximately 14 days following completion of the call by dialing (888) 843-7419 or (630) 652-3042 and use the participant passcode: 4409 6372#. A replay will also be available on MannKind's website for 14 days. |
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Post by lakers on Oct 17, 2017 11:25:56 GMT -5
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Post by dreamboatcruise on Oct 17, 2017 11:33:40 GMT -5
Why is this being posted now? Looks like old news. |
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Post by lakers on Oct 17, 2017 18:14:11 GMT -5
OUTSULIN Trade mark is active in Australia, Mexico, pending in Canada, U.S. With a new label, could there be partners in Australia, Mexico, Canada? www.wipo.int/branddb/en/search for OUTSULIN 1735286 - OUTSULIN Status: Active (2017-03-22)
(111) Registration Number 1735286 (151) Date of the registration 2017-03-22 (210) Serial number of the application 0119851820281 (220) Date of filing of the application 2016-11-11 (731) Name and address of the applicant MANNKIND CORPORATION RYE CANYON LOOP NUM. EXT. 25134 NUM. INT. SUITE 300 VALENCIA, CA., ESTADOS UNIDOS DE AMERICA (91355) (740) Name and address of the representativeANTONIO BELAUNZARAN MARTINEZ
PEDRO LUIS OGAZON NUM. EXT. 17, SAN ANGEL
ALVARO OBREGON, CIUDAD DE MEXICO (01000)
(511) The International Classification of Goods and Services for the Purposes of the Registration of Marks (Nice Classification) and the list of goods and services classified according thereto 5PRODUCTOS FARMACEUTICOS, A SABER, PREPARACIONES FARMACEUTICAS PARA EL TRATAMIENTO DE LA DIABETES, ENFERMEDADES Y DESORDENES ENDOCRINOS, ENFERMEDADES Y DESORDENES METABOLICOS; PREPARACIONES FARMACEUTICAS QUE CONTIENES INSULINA. 1808539 - OUTSULIN Status: Registered/Protected(151) Date of the registration 2016-11-10 (731) Name and address of the applicant MannKind Corporation a Delaware corporation 25134 Rye Canyon Loop Suite 300 Valencia CA 91355 US (750) Address for correspondence
Davies Collison Cave Pty Ltd
Level 15
1 Nicholson Street
MELBOURNE
VIC
3000
AU
(511) The International Classification of Goods and Services for the Purposes of the Registration of Marks (Nice Classification) and the list of goods and services classified according thereto 5 Pharmaceutical products, namely, pharmaceutical preparations for the treatment of diabetes, endocrine diseases and disorders, metabolic diseases and disorders; pharmaceutical preparations containing insulin44 Medical information App.1810093 - OUTSULIN Status: Trade-mark: Advertised(210) Serial number of the application 1810093 (220) Date of filing of the application 2016-11-18 (527) Indications regarding use requirements Proposed Use in CANADA
(300) Data relating to priority under the Paris Convention and other data relating to registration of the mark in the country of origin Priority Filing Date: May 18, 2016, Country: UNITED STATES OF AMERICA, Application No. 87042197 in association with the same kind of goods and in association with the same kind of services (550) Indication relating to the nature or kind of mark Trade-mark (Word Mark) (731) Name and address of the applicant MannKind Corporation 25134 Rye Canyon Loop Suite 300 Valencia, CA 91355 US (740) Name and address of the representative
GOWLING WLG (CANADA) LLP
SUITE 1600
1 FIRST CANADIAN PLACE
100 KING STREET WEST
TORONTO
ONTARIO
M5X1G5
CA510) List of goods and/or services, if not classified (1) Pharmaceutical products, namely, pharmaceutical preparations for the treatment of diabetes, endocrine diseases and disorders, metabolic diseases and disorders; pharmaceutical preparations containing insulin (1) Medical information |
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Post by brotherm1 on Oct 17, 2017 20:16:36 GMT -5
Why is this being posted now? Looks like old news. Current news: He’s not sold |
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Post by casualinvestor on Oct 18, 2017 7:36:18 GMT -5
Link to verify that? Months back when I did some Edgar research, it looked like he had received those shares for Deerfield (Apr 18th was the announcement of the first debt for share swap with Deerfield). Then on 6/30/17 Deerfield filed that they had ~2.7 million shares.
On 7/1/17 Deerfield received another 3.x million shares in the second debt for shares swap. We get to see how many they still have in a few more weeks
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Post by mnholdem on Oct 18, 2017 8:09:33 GMT -5
I'm fairly certain that stock owned by James Flynn and stock owned by Deerfield are separate accounts.
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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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