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Post by mannmade on Jul 18, 2018 16:18:32 GMT -5
Add $2m from India and another $2m to $3m from next term sheet (China anyone?) and voila we make guidance. Don’t recall mike staying all revenue was related to us script sales only but could be wrong. 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? 🙏
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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.
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Post by peppy on Jul 18, 2018 16:28:56 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? 🙏 Population: 207.7 million (2016) 1 Brazilian Real equals 0.26 United States Dollar Monthly incomes:
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Post by aceton3 on Jul 18, 2018 17:58:10 GMT -5
Felt Compelled:
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Post by golfeveryday on Jul 18, 2018 19:47:39 GMT -5
It should be announced shortly. It could shed some lights on some FAQs such as: What publication and when will the STAT result be published? Where and when will be the next international expansion ? Why didn’t we expand in Canada, Mexico due to no NAFTA tariff? MENA, China expansion have been often bandied about. When will that happen? Any update on improved coverage? Is TV Ads still going considering the cash crunch? Any near term cash infusion from potential partners? When will phase one pediatric trial complete ? fast track ped trial, TrepT partner,
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Post by brotherm1 on Jul 18, 2018 22:24:58 GMT -5
Felt Compelled: Over 10% making over $42K. 12 million with diabetes. Then possibly around 1.2 million with diabetes making over $42K
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Post by aceton3 on Jul 18, 2018 23:37:10 GMT -5
Felt Compelled: Over 10% making over $42K. 12 million with diabetes. Then possibly around 1.2 million with diabetes making over $42K Just looking at the top 1% - around 2.02 million, and a diabetes rate of ~5.5% for that demographic, you're looking at a market of around 111,100.
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Post by casualinvestor on Jul 19, 2018 8:36:45 GMT -5
Afrezza will be a lot cheaper in Brazil than in the US. As long as it's sold above cost, it's all good. Is a sale to Brazil likely to be a bulk purchase by the gov't?
I also thought I remembered Mike C talk about selling at a lower cost elsewhere helping out with profitability in the US from economies of scale. That might have been in relation to India, but it would certainly apply in Brazil too.
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Post by bioexec25 on Jul 19, 2018 8:49:59 GMT -5
Afrezza will be a lot cheaper in Brazil than in the US. As long as it's sold above cost, it's all good. Is a sale to Brazil likely to be a bulk purchase by the gov't? I also thought I remembered Mike C talk about selling at a lower cost elsewhere helping out with profitability in the US from economies of scale. That might have been in relation to India, but it would certainly apply in Brazil too. Yes I do recall at the ASM Mike mentioning some lower margins o.US countries contributing to yearly insulin commitments while the more profitable US continues to scale.
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Post by Deleted on Jul 19, 2018 10:28:49 GMT -5
Afrezza will be a lot cheaper in Brazil than in the US. As long as it's sold above cost, it's all good. Is a sale to Brazil likely to be a bulk purchase by the gov't? I also thought I remembered Mike C talk about selling at a lower cost elsewhere helping out with profitability in the US from economies of scale. That might have been in relation to India, but it would certainly apply in Brazil too. New drug uptake into the market in Brazil; quicker, slower or about the same as the US? Who are the decision makers in Brazil; doctors, payors, patient? Who pays for the Rx in Brazil; government, insurance, patient out of pocket? If new drug adoption rates are faster in Brazil than the US, in general terms, how much faster?
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Post by traderdennis on Jul 19, 2018 10:57:32 GMT -5
Afrezza will be a lot cheaper in Brazil than in the US. As long as it's sold above cost, it's all good. Is a sale to Brazil likely to be a bulk purchase by the gov't? I also thought I remembered Mike C talk about selling at a lower cost elsewhere helping out with profitability in the US from economies of scale. That might have been in relation to India, but it would certainly apply in Brazil too. New drug uptake into the market in Brazil; quicker, slower or about the same as the US? Who are the decision makers in Brazil; doctors, payors, patient? Who pays for the Rx in Brazil; government, insurance, patient out of pocket? If new drug adoption rates are faster in Brazil than the US, in general terms, how much faster? en.wikipedia.org/wiki/Healthcare_in_BrazilHealth supplies Brazil is among the greatest consumers markets for drugs, accounting for 3.5% share of the world market. To expand the access of the population to drugs, incentives have been offered for marketing generic products, which cost an average of 40% less than brand-name products. In 2000, there were 14 industries authorized to produce generic drugs and about 200 registered generic drugs were being produced in 601 different forms. Health sector expenditure In 1998 national health expenditure amounted to US$62,000 million, which corresponded to nearly 7.9% of GDP. Of that total, public spending accounted for 41.2% and private expenditure accounted for 58.8%. In per capita terms, public spending is estimated at US$158 and private expenditure at US$225.
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Post by peppy on Jul 19, 2018 11:12:58 GMT -5
New drug uptake into the market in Brazil; quicker, slower or about the same as the US? Who are the decision makers in Brazil; doctors, payors, patient? Who pays for the Rx in Brazil; government, insurance, patient out of pocket? If new drug adoption rates are faster in Brazil than the US, in general terms, how much faster? en.wikipedia.org/wiki/Healthcare_in_BrazilHealth supplies Brazil is among the greatest consumers markets for drugs, accounting for 3.5% share of the world market. To expand the access of the population to drugs, incentives have been offered for marketing generic products, which cost an average of 40% less than brand-name products. In 2000, there were 14 industries authorized to produce generic drugs and about 200 registered generic drugs were being produced in 601 different forms. Health sector expenditure In 1998 national health expenditure amounted to US$62,000 million, which corresponded to nearly 7.9% of GDP. Of that total, public spending accounted for 41.2% and private expenditure accounted for 58.8%. In per capita terms, public spending is estimated at US$158 and private expenditure at US$225.quote: Brazil is among the greatest consumers markets for drugs, accounting for 3.5% share of the world market. at US$158 and private expenditure at US$225. reply: they used to say, "you can't get water out of a rock."
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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%.
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Post by tinkusr8215 on Jul 19, 2018 11:35:14 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.
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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.
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