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Post by peppy on Aug 8, 2017 6:11:26 GMT -5
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Post by peppy on Aug 8, 2017 7:08:01 GMT -5
Physicians quote: The number one thing I heard the most was continue to show up to my office, continue to be there front and center present, and also as I looked at endocrinologist versus primary care doctors, there was a much larger opportunity than I expected in terms of receptivity by primary care doctors being willing to prescribe Afrezza because they felt that they have mastered the basal treatment patterns for patient and were looking to using GLPs and that's a logical next step if they hadn't inhaled insulin that they would continue to learn how to use and prescribe insulin.
Many times they tried their best to manage these patients, they struggle with where to go, and how to get there and how long they stay with elevated A1C and they try to get the one inject insulin but often times it's years before they progress to an endocrinologist.
So one of the things we saw last year was a modeling of the simulation data thing had we dozed Afrezza properly and appropriately in our trials, we felt very confident we've had a superior insulin. That is obviously not our label says, but that’s some of the investments you’ll hear from today that we’re starting to make in the announced of the One Drop as well as the step study that Pat will talk about.
We know there are over 22 million people in treatment . ------------------------------------------------------------------------------------ I am glad to see the switch in focus to primary care.
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Post by peppy on Aug 8, 2017 7:19:21 GMT -5
We know we have to recapitalize the company but doing that without the rest in front of us was one of my first priorities and I want really want to increase our optionality.
So with that you saw this afternoon, we announced that we withdraw from the [Telsey] stock exchange. We’re doing this for a couple of reason. We want to simplify our filings, we want to reduce our expenses, and also it's freeze up 10 million preferred shares.
Number two, we reduced our day filed obligations by 15 million through conversion of equity, as well as 4 million in cash payments. While this does reduce our debt burning, we did increase our debt to withdraw down the Mann Foundation $30 million. And what that does is really in effect change the interest rate from a high yield debt to a low yield debt while pushing out any near term obligations. As a result of that we did increase our cash by $19.4 million through the Mann Group.
Finally, we reduced our operating cash burn quarter-over-quarter despite having a fully expanded commercial transition. This burn was approximately $6.9 million a month not including the $4 million that was paid in capital to Deerfield.
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Post by peppy on Aug 8, 2017 7:28:42 GMT -5
insurance coverage: We continued with commercial improvement in our insurance coverage. As I previously announced, we had Anthem on April 1, we renewed the VA contract and we’re now working on reducing high authorization burdens.
For example, we know contract that continue to have Novolog as preferred exclusive agent. Those contracts and the terms within those prior authorizations typically will say something to the nature of in order to get Afrezza you must fail insulin and have physical and invisible disabilities. And we don't believe it's fair that healthy patients who desire better health should have to fail every aspect of your life before they get access to Afrezza.
We continue to work with places like United and CBS to reduce the burden of the prior authorizations. We’re okay if patients have to fail insulin to get to our product, but we don't think it's fair that patients have to go potentially be visually impaired and physically disabled. So we will continue to open up those opportunities. We had some success already in that nature.
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so we see the pharmacy managers controlling prescribed medication? hmmmm. working in conjunction with the FDA. (?) So if an individual is visually and physically impaired Afrezza is a better choice?
What is visually impaired from diabetes?
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Post by peppy on Aug 8, 2017 7:37:05 GMT -5
expansion:
Finally on this topic, we announced our international expansion with Brazil, that is on track to file our meeting request by the end of this year and what will next happen is a inspection of our manufacturing facilities will occur and at that point we will be ready to file the application with an expectation of potential approval in late 2018.
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Post by straightly on Aug 8, 2017 8:15:27 GMT -5
insurance coverage: We continued with commercial improvement in our insurance coverage. As I previously announced, we had Anthem on April 1, we renewed the VA contract and we’re now working on reducing high authorization burdens.
For example, we know contract that continue to have Novolog as preferred exclusive agent. Those contracts and the terms within those prior authorizations typically will say something to the nature of in order to get Afrezza you must fail insulin and have physical and invisible disabilities. And we don't believe it's fair that healthy patients who desire better health should have to fail every aspect of your life before they get access to Afrezza.
We continue to work with places like United and CBS to reduce the burden of the prior authorizations. We’re okay if patients have to fail insulin to get to our product, but we don't think it's fair that patients have to go potentially be visually impaired and physically disabled. So we will continue to open up those opportunities. We had some success already in that nature.
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so we see the pharmacy managers controlling prescribed medication? hmmmm. working in conjunction with the FDA. (?) So if an individual is visually and physically impaired Afrezza is a better choice?
What is visually impaired from diabetes?
Amputated for sure. Pretty sure cutting off a finger would count. Just make sure you start while your patient can still breath. Remain me of the movie the Rainmakers, which show that we did make some progress and a long way to go. |
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Post by boca1girl on Aug 8, 2017 8:22:43 GMT -5
expansion: Finally on this topic, we announced our international expansion with Brazil, that is on track to file our meeting request by the end of this year and what will next happen is a inspection of our manufacturing facilities will occur and at that point we will be ready to file the application with an expectation of potential approval in late 2018.So much for the expedited approval in Brazil. Another 1.5 years away. |
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Post by peppy on Aug 8, 2017 9:54:23 GMT -5
insurance coverage: We continued with commercial improvement in our insurance coverage. As I previously announced, we had Anthem on April 1, we renewed the VA contract and we’re now working on reducing high authorization burdens.
For example, we know contract that continue to have Novolog as preferred exclusive agent. Those contracts and the terms within those prior authorizations typically will say something to the nature of in order to get Afrezza you must fail insulin and have physical and invisible disabilities. And we don't believe it's fair that healthy patients who desire better health should have to fail every aspect of your life before they get access to Afrezza.
We continue to work with places like United and CBS to reduce the burden of the prior authorizations. We’re okay if patients have to fail insulin to get to our product, but we don't think it's fair that patients have to go potentially be visually impaired and physically disabled. So we will continue to open up those opportunities. We had some success already in that nature.
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so we see the pharmacy managers controlling prescribed medication? hmmmm. working in conjunction with the FDA. (?) So if an individual is visually and physically impaired Afrezza is a better choice?
What is visually impaired from diabetes?
Amputated for sure. Pretty sure cutting off a finger would count. Just make sure you start while your patient can still breath. Remain me of the movie the Rainmakers, which show that we did make some progress and a long way to go. back to this. There have been several posters in twitter complaining about united health. this explains more: 17 July 2017. Then United Healthcare decided to take away my happiness and tell me they know what’s best for me. I first received a letter saying that “…United Healthcare Services inc on behalf of Oxford is unable to approve the coverage request for Afrezza…”. As I read the letter the date of request was 07/12/2017 and the date of decision was 07/12/2017. If you have ever had to deal with health insurance, you know they never do anything quickly, and definitely not in the same day, unless its screwing over their clients. So I called them and was on hold for 45 minutes, hung up on and then called back and transferred to 6 different people. I was on the phone from 8PM to 12:37AM. I never got an answer, but was told that the doctor who prescribed the medication for me must fill out the appeal forms and then they will review it. I called my doctor the next morning, and she told me that they are working on it now and will let me know once it has been finished.
7 August 2017. The denial letter arrives at my house stating that this person Nidhi Gupta M.D who claims to be a United Healthcare Medical Director, specializing in Internal Medicine knows what is better for me than my actual doctor. This person does not know anything about my medical history or has ever met me, but they know what is best for me. This is outrageous. The only reasons that someone would get approved for this is if they are blind, they are unable to inject insulin from a physical impairment, their bodies are so deformed from taking so many shots it’s almost impossible to do, or that have a needle phobia. I do not fall in to any of those categories, so unless I want to cut off my hands, blind myself, ruin my body or lie about having a phobia of needles, I am screwed. kevinnicholasgavit.com/2017/08/08/stop-united-healthcare/ This is also what the physician is going through? Has anyone counted laura K's toes?
www.uhc.com/
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Post by peppy on Aug 8, 2017 11:21:44 GMT -5
Our total net revenues for the second quarter of 2017 was $2.2 million, which included $1.5 million of Afrezza product net revenue, which they 29% increase over the first quarter of 2017. Also included in second quarter net revenue was $0.6 million of other revenue from the sale of oncology related intellectual property to a Chinese company.
At June 30, 2017 we had $2.6 million in deferred revenue per product that have been shipped to the wholesale and retail channels but was not yet dispensed to patients and recognized as revenue.
Interest expense was $3.1 million for the quarter ended June 30, 2017
We incurred a net loss of $35.3 million or loss per share of $0.35
Cash and cash equivalents at June 30, 2017 were $43.4 million
Cash and cash equivalents at June 30, 2017 were $43.4 million compared to $48 million at March 31, 2017 and $22.9 million at December 31, 2016. During the second quarter we received cash of $19.4 million from increasing the Mann Group obligation plus $2 million from shipments of Afrezza while making principal and interest payments of $5.6 million on our debt and an operating cash reduction of $22.1 million. ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- help me out here. plus $2 million from shipments of Afrezza . (?)
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Q1 2017 included cash received from Sanofi up $30.6 million and $16.7 million from the sale of real estate in Valencia California. As we focus on supporting the upward trajectory of Afrezza sales and tightly manage our cash operating expenses, we expect Afrezza gross revenue for the second half of 2017 to be in the range of $9 million to $14 million. Net revenue for the second half 2017 to be in the range of $6 million to $10 million and an applicable growth to net reduction in the range of 30% to 35%.
----------------------------------------------------------------------------------------------------------------------------------------------------------------- Afrezza a net revenue of 1.5 second second quarter. 1,196 first quarter. = 2.7 million afrezza net revenue for the first half. projecting to 9 to 14 million next quarter. ---------------------------------------------------------------------------------------------------------------------------------------------------------------------
We also forecast our operating cash burn which is exclusive of debt principal payments to between $18 million to $24 million per quarter in the second half of 2017. We continue to work with our advisors [Greenhill] company and recapitalization options as this is our priority for the second half of 2017 along with the driving Afrezza sales growth.
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Post by compound26 on Aug 8, 2017 11:54:28 GMT -5
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----------------------------------------------------------------------------------------------------------------------------------------------------------------- Afrezza a net revenue of 1.5 second second quarter. 1,196 first quarter. = 2.7 million afrezza net revenue for the first half. projecting to 9 to 14 million next quarter. ---------------------------------------------------------------------------------------------------------------------------------------------------------------------
We also forecast our operating cash burn which is exclusive of debt principal payments to between $18 million to $24 million per quarter in the second half of 2017. We continue to work with our advisors [Greenhill] company and recapitalization options as this is our priority for the second half of 2017 along with the driving Afrezza sales growth.
, I think you are getting the numbers mixed here seriously.  "9-14 million net revenue for the next quarter" is not what Mannkind is projecting and is not going to happen! Think about it, in the last quarter, the net revenue grew 29% and gross income grew 60%. From 1.5 million to 9 million, you are asking for a 500% quarter to quarter growth. From 1.5 million to 14 million, you are asking for a 833% quarter to quarter growth. My understanding of the projection is for a 9 to 14 million gross (and 6 to 10 million net) for the second half of 2017. I think they are basically forecasting a 50% growth quarter over quarter. So here is the what they are projecting, in terms of net revenue growth: 1.2 (1st quarter) 1.8 (2nd quarter) [this quarter they reported 1.5 million, but says there was a 0.3 million one-time fee that will not occur. So we can deem the actual revenue for the 2nd quarter as 1.8 million, rather than 1.5 milloin].
2.7 (3rd quarter)
4.0 (4th quarter)
And that is 6.7 million (2.7 million + 4.0 million) net revenue for the 2nd half of 2017. Right in between the projection (6-10 million net revenue for the 2nd half of 2017).
If they can do that, I will be pretty happy. |
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Post by peppy on Aug 8, 2017 12:21:19 GMT -5
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----------------------------------------------------------------------------------------------------------------------------------------------------------------- Afrezza a net revenue of 1.5 second second quarter. 1,196 first quarter. = 2.7 million afrezza net revenue for the first half. projecting to 9 to 14 million next quarter. ---------------------------------------------------------------------------------------------------------------------------------------------------------------------
We also forecast our operating cash burn which is exclusive of debt principal payments to between $18 million to $24 million per quarter in the second half of 2017. We continue to work with our advisors [Greenhill] company and recapitalization options as this is our priority for the second half of 2017 along with the driving Afrezza sales growth.
, I think you are getting the numbers mixed here seriously. "9-14 million net revenue for the next quarter" is not what Mannkind is projecting and is not going to happen! Think about it, in the last quarter, the net revenue grew 29% and gross income grew 60%. From 1.5 million to 9 million, you are asking for a 500% quarter to quarter growth. From 1.5 million to 14 million, you are asking for a 833% quarter to quarter growth. My understanding of the projection is for a 9 to 14 million gross (and 6 to 10 million net) for the second half of 2017. I think they are basically forecasting a 50% growth quarter over quarter. So here is the what they are projecting, in terms of net revenue growth: 1.2 (1st quarter) 1.8 (2nd quarter) [this quarter they reported 1.5 million, but says there was a 0.3 million one-time fee that will not occur. So we can deem the actual revenue for the 2nd quarter as 1.8 million, rather than 1.5 milloin].
2.7 (3rd quarter)
4.0 (4th quarter)
And that is 6.7 million (2.7 million + 4.0 million) net revenue for the 2nd half of 2017. Right in between the projection (6-10 million net revenue for the 2nd half of 2017).
If they can do that, I will be pretty happy. as always thank you compound. I miss typed, yes, those projection estimates the second half.
quote: I think they are basically forecasting a 50% growth quarter over quarter.
So: 2.7 (3rd quarter)
4.0 (4th quarter)
From The CC: Jason McCarthy
Hi guys congratulations on completing your first quarter with the new commercial team in place. Michael, can you talk a little bit more about the upcoming labeling change maybe give us a sense of the timing of the change and how you expect that to impact revenues in 2017 and going forward into 2018?
Mike C: I think about it in three steps one there is the ability to articulate that the drug starts working within five minutes. The second part is we can articulate that it is faster than the competition. And the third is asking for a different category altogether. The important of these commercially really vary in terms of impact now in the second half of 2017 but as we go in 2018 and beyond. As repute to communicate we expect PDUFA approval by the end of Q3. So this will be a Q4 event in terms of launch and impact.
So for example if we were to get a different category that opens up a lot of the managed care access, if we takes that out of the bucket that we’re currently restricted in by the competition. So we don’t always control the buckets they’re consumed by the PBMs that drive 70% of the units in the country that really opens that window a little bit. It also dramatically could change Medicare Part D coverage.
When it comes to the speed of onset saying we work within five minutes the reason that's important as we’re running these trials right now with DexCom and what you can see is within three dots on the DexCom you can see whether you got your appropriate dose we need to follow up the dose. Being able to have the clinical data that we kicked off coming out in time frame and read for us internally to know what the label change is going to be we are waiting to see a couple dots on their CGM which way did overshoot or undershoot for dosing in order to pull them back into time and range very quickly. We expect that the five minutes claim to be in there the data supports that and something we’re excited about. The other thing I can tell you is when we shared that PK/PD curve with the physician and asked them what does this mean to you the five-minute onset meant more to the physician than we expected in terms of just understanding the PK/PD is a product the speed of onset, getting out of body fast and all the things that come without backing of insulin and injecting. So that really gave them some confidence around how to mince with a drug and what they can communicate to the patient's.
And then getting out of body faster and we know to make that claim is read our label today we say we get in the body faster, but we can't necessarily say we work any faster. And that’s been something that’s been bothering us since launch. And this to me is a very important label update is it really will allow to finally articulate the true profile of this product at least from the PK/PD. When you take that label change plus the work that Ray has been doing and his team that we’re really working on this one-two punch combination and when it comes to some of these things. I hope that answer your question Jason.
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