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Post by peppy on Sept 5, 2018 14:00:59 GMT -5
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Post by joshbam on Sept 5, 2018 14:11:56 GMT -5
First time poster. Curious about the market share shown in TRx slide... 900 scrips is 4%?? This seems like a VERY small market... based on $45M now, 50% share would only be $500M-ish revenue per year. What am I missing?
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Post by peppy on Sept 5, 2018 14:26:46 GMT -5
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Post by peppy on Sept 5, 2018 14:33:40 GMT -5
First time poster. Curious about the market share shown in TRx slide... 900 scrips is 4%?? This seems like a VERY small market... based on $45M now, 50% share would only be $500M-ish revenue per year. What am I missing? not sure, this came to mind. outdated a bit, but you get the jist.
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Post by slapshot on Sept 5, 2018 15:01:20 GMT -5
First time poster. Curious about the market share shown in TRx slide... 900 scrips is 4%?? This seems like a VERY small market... based on $45M now, 50% share would only be $500M-ish revenue per year. What am I missing? I don't have the presentation handy, but saw it this morning... Are you confusing the 4% of doctors prescribing Afrezza to mean that Afrezza has 4% of the market share? If so, I believe that is what you are missing... Edit: my comment above was that I was looking at the slide that showed the % of prescribers when he talked of this. Looking at the quote below, I think the 8% and 4% is a month over month increase, not a total market share...
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Post by MnkdWASmyRtrmntPlan on Sept 5, 2018 15:04:57 GMT -5
Here's a small segment that I transcribed that includes that 4% thing - I'm still not sure what he meant by that. He talks so fast, but transcribing is really tedious. So, the question I always get about Afrezza is, is it going to be successful. When we look at gross sales, Sanofi handed this back to us doing 7 million to 9 million gross. We are on track now to do 40-45 million on a rolling forward basis in Gross Sales. We had some Gross to Net issues we had to deal with in 2018 as a new company. We had a lot of price penalties. We had a lot of new packaging changes we had to make. So, all those are 1-time events and as we go forward, we’ll be able to manage that. And, as our revenue grows, one of our biggest problems in our gross-to-net is wholesale fees. That actually is larger than our managed care discounts. And we know that as revenue grows, wholesale fees will come down as well. So, there’s a positive story here that we continue to grow. These are New Member Prescriptions, these are New to Brand. So, don’t look at Refills or NRx – this data is not always public on Bloomberg, but it’s new member (unintelligible). What this means is new to brand treatments, and you can see on the left, the blue bar started around 275, and today, in the month of July we had over 900. So, you can see Mannkind Commercial team is generating new to brand treatments and we continue to get positive momentum. And obviously the year started slower, but we’re seeing nothing but upswing momentum in this. This is our earliest indicator of our future success. Every month throughout this year. And the second thing is, we don’t target the whole audience in terms of all insulin prescribers. We target about 45-50% of the insulin market. And, once we do get a new prescriber, what you see is we had about a thousand prescribers in the month of July, and once we do get them we see about an 8% NewRx share and about a 4% TRx share, and so we are growing our share consistently month over month as we go forward, so it’s not a matter of if Afrezza will be successful, it’s a matter of when we will be cash-flow breakeven for the company. So, I was very positive about this. What we do know about all the investments we made in pilots is the better the rep, it’s very promotionally responsive. DTC had a nice impact when we looked in our datasets in terms of writers and no writers in areas we put consumer advertising. So, at this point, we know it’s a good drug. We now have some new capital, so we will increase our TV spend, and Afrezza will continue to grow for years to come as we look forward. Edit - Ha, I just finished this and I got the Seeking Alpha transcript in email. Oh well, it will be a good read. Here it is: seekingalpha.com/article/4204322-mannkind-corporation-mnkd-ceo-michael-castagna-presents-rodman-and-renshaw-20th-annual-global?app=1&dr=1
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Post by sportsrancho on Sept 5, 2018 15:11:26 GMT -5
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Post by lakers on Sept 5, 2018 15:46:00 GMT -5
we expect Brazil approval in Q4. We will then launch in Q1. It takes about 90 days for pricing negotiations down there. India is Cipla. We partner with one of the largest respiratory partners down in India. They have a huge diabetes portfolio they are building. Very excited to work with them. Phase 3 trial design is almost done. We will go to the regulatory authorities as we move that forward. And then Canada, had very positive feedback from Canada and Mexico also. So we expect to be able to file in those countries later this year or early next year and we will be going to EU next for discussions and some of the other countries. we were in various discussions with various Chinese partners and so there is a chance we will work on a China deal. At the same time, as we think about how much work it takes on our teams to work with individual partners versus one global partner, that's kind of where we took a little of a pause given where we were on everything and said, let's get out there done and then based on what we know as our bigger global partnership with one partner with one global rights outside of the two countries we have announced with partners already. So kind of preserving that option a little bit. But we will continue to, we are not going to slowdown our filing timelines. To me, it's more important to get those moving. It's not very expensive but we know it takes one to two years to get these things approved. So will continue to file in the countries we see as the most advantageous and then really look at global partnerships as part of the structure we are looking at. There is quite a few partners I have talked over the last year. We did some work back with Locust Walk and we have learned a lot through that process. So we will start to see Technosphere lot more. So we are looking to partner pipeline assets but also bring things in to compliment our current sales force to accelerate our sales growth [co-promo]. pediatric indication for Afrezza is another growth driver in early 2020. And so part one of the study just finished up. It's at the Data Safety Monitoring Board today and we expect part two to start momentarily as well as part three of that study. Once that's wrapped up, we can immediately go into Phase 3 for pediatrics. Our deal with United Therapeutics gives them exclusivity on pulmonary hypertension. We have excluded a couple of categories within that. But we are moving another drug within that category down into powder formulations. how do we take new chemicals entities that are shelved and now deliver them. And there is a lot more lung disease, a lot more orphan condition [qualify for PRV which could be traded for $100 M’s] that we believe we can start to put Technosphere on and start to deliver drug therapeutic targets and NCEs. The $10M R&D I believe is for work on Inhaled tacrolimus. Effect of inhaled tacrolimus on ischemia reperfusion injury in rat lung transplant model www.sciencedirect.com/science/article/pii/S0022522313008076Inhaled tacrolimus modulates pulmonary fibrosis without promoting inflammation in bleomycin-injured mice www.sciencedirect.com/science/article/pii/S1773224714500901Read more: mnkd.proboards.com/thread/4937/meet-pahs-tacrolimus-treprostinil-inhibitor#ixzz5QGQ8Oo4QExcluding category from UTHR Deal, I believe, is Sildenafil (Viagra®), PDE5 inhibitor, in the treatment of pulmonary hypertension www.tandfonline.com/doi/full/10.1586/14779072.4.3.293?scroll=top&needAccess=true
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Post by cretin11 on Sept 5, 2018 15:49:15 GMT -5
Mike mentioned the cricket inhaler for an anxiety formulation. I need a Antixiety script please. Kindxiety. MNKD shareholders should get a complimentary supply of that.
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Post by mike0475 on Sept 5, 2018 15:52:56 GMT -5
We’re going to need an inhaled victory cigar formulation
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Post by awesomo on Sept 5, 2018 16:00:10 GMT -5
Afrezza snippets...
And as our revenue grows, one of the biggest problems in our gross to net is wholesale fees actually is larger than our managed care discounts. And we know that as revenue grows, wholesale fees will come down as well. So there's a positive story here that we continue to grow. These are new member prescriptions. So these are new to brand. So don't look at refill, don't look at NRx. This data is not always public on Bloomberg. But it's new member RX. What this means is, these are new to brand treatment and you can see on the left the blue bar start around 275 and today in the month of July we had over 900. So you can see MannKind's commercial team is generating new to brand treatments and we would continue to get positive momentum and obviously the year started slower, but we are seeing nothing but upswing momentum and this is our earliest indicator of our future success every month throughout this year.
So exciting times ahead. I have sat at companies that turned around that's been through the worst and I really do feel good about our future and we kind of now have enough capital and based on our budgets, remember, we can always cut costs at the end of the day if we don't think Afrezza is the drug to bet on. But we do know the upside on Afrezza is lot way higher than the downside for the company. So we will continue to invest to grow our lead brand here and make it successful.
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Post by sportsrancho on Sept 5, 2018 17:38:59 GMT -5
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Post by mango on Sept 6, 2018 4:30:02 GMT -5
we expect Brazil approval in Q4. We will then launch in Q1. It takes about 90 days for pricing negotiations down there. India is Cipla. We partner with one of the largest respiratory partners down in India. They have a huge diabetes portfolio they are building. Very excited to work with them. Phase 3 trial design is almost done. We will go to the regulatory authorities as we move that forward. And then Canada, had very positive feedback from Canada and Mexico also. So we expect to be able to file in those countries later this year or early next year and we will be going to EU next for discussions and some of the other countries. we were in various discussions with various Chinese partners and so there is a chance we will work on a China deal. At the same time, as we think about how much work it takes on our teams to work with individual partners versus one global partner, that's kind of where we took a little of a pause given where we were on everything and said, let's get out there done and then based on what we know as our bigger global partnership with one partner with one global rights outside of the two countries we have announced with partners already. So kind of preserving that option a little bit. But we will continue to, we are not going to slowdown our filing timelines. To me, it's more important to get those moving. It's not very expensive but we know it takes one to two years to get these things approved. So will continue to file in the countries we see as the most advantageous and then really look at global partnerships as part of the structure we are looking at. There is quite a few partners I have talked over the last year. We did some work back with Locust Walk and we have learned a lot through that process. So we will start to see Technosphere lot more. So we are looking to partner pipeline assets but also bring things in to compliment our current sales force to accelerate our sales growth [co-promo]. pediatric indication for Afrezza is another growth driver in early 2020. And so part one of the study just finished up. It's at the Data Safety Monitoring Board today and we expect part two to start momentarily as well as part three of that study. Once that's wrapped up, we can immediately go into Phase 3 for pediatrics. Our deal with United Therapeutics gives them exclusivity on pulmonary hypertension. We have excluded a couple of categories within that. But we are moving another drug within that category down into powder formulations. how do we take new chemicals entities that are shelved and now deliver them. And there is a lot more lung disease, a lot more orphan condition [qualify for PRV which could be traded for $100 M’s] that we believe we can start to put Technosphere on and start to deliver drug therapeutic targets and NCEs. The $10M R&D I believe is for work on Inhaled tacrolimus. Effect of inhaled tacrolimus on ischemia reperfusion injury in rat lung transplant model www.sciencedirect.com/science/article/pii/S0022522313008076Inhaled tacrolimus modulates pulmonary fibrosis without promoting inflammation in bleomycin-injured mice www.sciencedirect.com/science/article/pii/S1773224714500901Read more: mnkd.proboards.com/thread/4937/meet-pahs-tacrolimus-treprostinil-inhibitor#ixzz5QGQ8Oo4QExcluding category from UTHR Deal, I believe, is Sildenafil (Viagra®), PDE5 inhibitor, in the treatment of pulmonary hypertension www.tandfonline.com/doi/full/10.1586/14779072.4.3.293?scroll=top&needAccess=trueTacrolimus is a diabetogenic so there's no way they would be doing that
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Post by mnholdem on Sept 6, 2018 7:34:50 GMT -5
Drugs and Supplements Tacrolimus (Oral Route)
US Brand Name Astagraf XL Envarsus XR Hecoria Prograf
Descriptions
Tacrolimus is used together with other medicines to prevent the body from rejecting a transplanted organ (eg, kidney, liver, or heart). This medicine may be used with steroids, azathioprine (Imuran®), basiliximab (Simulect®), or mycophenolate mofetil (Cellcept®). Tacrolimus belongs to a group of medicines known as immunosuppressive agents.
When a patient receives an organ transplant, the body's white blood cells will try to get rid of (reject) the transplanted organ. Tacrolimus works by suppressing the immune system to prevent the white blood cells from trying to get rid of the transplanted organ.
Tacrolimus is a very strong medicine. It can cause side effects that can be very serious, such as kidney problems. It may also decrease the body's ability to fight infections. You and your doctor should talk about the benefits of this medicine as well as the risks of using it.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms: • Capsule • Capsule, Extended Release • Tablet, Extended Release
Source: www.mayoclinic.org/drugs-supplements/tacrolimus-oral-route/description/drg-20068314
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Post by mnholdem on Sept 6, 2018 7:50:52 GMT -5
Why was Tacrolimus mentioned?
Consider this excerpt from United Therapeutics earnings call:
"Let’s now transition to our product pipeline, which currently consists of numerous investigational programs including therapies for PAH and other forms of pulmonary hypertension, innovative drug delivery devices, gene therapy and oncology. We will also continue to work on technologies to ultimately create an unlimited supply of tolerable, transplantable manufactured organs for those who suffer from end-stage organ disease." - CEO Martine Rothblatt
seekingalpha.com/article/4193068-united-therapeutics-uthr-ceo-martine-rothblatt-q2-2018-results-earnings-call-transcript
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