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May 9, 2018 23:20:50 GMT -5
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Post by cjm18 on May 9, 2018 23:20:50 GMT -5
“We also maintain our guidance for net cash used in operating activities in the $90 million to $100 million range. We started the year with $48.4 million in cash and raised $27 million in equity offering year-to-date giving a $75 million in cash before the impact of cash used in operating activities. This means that we will still need additional cash in the range of $15 million to $25 million for 2018, ”
Uhh this assumes Deerfield removes the 25m threshold completely.
We need 40m to 50m. The warrants wouldn’t cover this.
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May 10, 2018 5:03:51 GMT -5
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Post by pat on May 10, 2018 5:03:51 GMT -5
Yes. Will the REMS removal and Stat study translate to more sales. If not it’ll be more dilution.
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May 10, 2018 6:11:57 GMT -5
Post by matt on May 10, 2018 6:11:57 GMT -5
Yes. Will the REMS removal and Stat study translate to more sales. If not it’ll be more dilution. The biggest impact of REMS was that the sales force had to mention it when detailing a new physician, but nothing more. I doubt it really had much of an impact on sales. STAT, due to its design, is set to deliver a positive message but it is a very small study that is not controlled and those don't change physician behavior much. Will those two items help? No doubt they will, but expect incremental improvements not hockey stick growth rates. The fact is that the company burns cash at rates that far exceed the increase in profit contribution from additional sales. They will be in cash raising mode for at least several more years.
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Post by pat on May 10, 2018 6:29:31 GMT -5
I disagree. I expect we’ll see a marked improvement in sales by the fall.
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Post by mnholdem on May 10, 2018 6:50:10 GMT -5
I think what is more importance to sales growth is educating physicians on the science behind Afrezza. Mike Castagna touched on this during the call:
"...we had an ADA late-breaking poster accepted around hypoglycemia and really demonstrating the differences of Afrezza versus other meal time insulin options. We believe the complete dataset when you look at the hypoglycemia plus STAT plus the history of the safety and efficacy of this product across the 65 trials, we start to educate the physicians on all the data we have, and they're very responsive."
This indicates to me that Dr. Kendall's team has been assimilating Afrezza trial data and are preparing medical publications. Endocrinologists and other Primary Care Physicians are not likely to prescribe any drug if they don't understand it.
"David has done a phenomenal job at really building thought leader relationships, helping us articulate the science, and really crunching through some new data analysis as we go forward. So look forward to continuing to see the scientific platform around Afrezza, as well as our pipeline with Treprostinil move forward."
"It is something we are going to look to partner as we go forward so that we can continue to reinvest and capitalize the company and Afrezza. The STAT study results are accepted for ADA, we announced that during Q1. That will be an oral presentation as well as a poster presentation. And just to remind you, that study was looking at using Dexcom's CGM looking at timing range and post-perennial controls of one to four hours. We believe this is really important as we've not had data to share in a head-to-head study against a meal-time injectable insulin. For the first time we'll have that data out there, and can reinforce what we've seen on social media and people showing their charts."
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I've been thinking about a few recent posts here on ProBoards-MNKD where members wrote how some of their physicians stated that they want to wait to prescribe Afrezza until they know more about it. Let's face it, there hasn't been a whole lot of medical information published and what has been published has been lacking in detail, specifically, direct comparisons to RAA insulin treatments.
Mike's mention of "what we've seen on social media" is, I think, referring to the CGM graphs that Afrezza patients have been sharing. The old adage "a picture is worth a thousand words" applies here. It seems to me that MannKind is preparing a new marketing campaign (which Mike stated will start at the ADA in June) that will feature Time-in-Range data using CGM data displays, as well as statistically significant reduction of A1c levels.
Mike announced (see above) another late-breaking poster has been accepted by the ADA that will show a direct comparison of Afrezza against insulin aspart in reducing severe hypoglycemic excursions and indications are that Technosphere insulin performed significantly better than the comparator RAA insulin.
Endos & PCPs can relate to A1c and hypo reductions. They've been using those measures for two decades. Once more doctors better understand the science behind Afrezza, including how to effectively titrate and establish dosing for their patients, then they'll begin prescribing it.
I've said it many times and I'll say it again: the science will prevail. The cash will follow.
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May 10, 2018 6:58:25 GMT -5
Post by myocat on May 10, 2018 6:58:25 GMT -5
Most of us here voted for a blank check. They can write the amount anytime.
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May 10, 2018 7:14:38 GMT -5
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Post by cjm18 on May 10, 2018 7:14:38 GMT -5
Ok let’s assume sales pick up. Sales need to pick up to hit guidance. Hitting guidance still means 40m-50m more needed.
Will the share price jump when/if sales jump? Will it jump enough to use warrants? We will have 150m outstanding shares at that point. 1b market cap will be under 7 bucks. Will publicizing select trials of the 65 help? Were those comparing afrezza to injectables? Will there be a trep partner this year after phase 1? That seems Early
short interest is going to go back up as the cash decreases.
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Post by traderdennis on May 10, 2018 7:52:19 GMT -5
“We also maintain our guidance for net cash used in operating activities in the $90 million to $100 million range. We started the year with $48.4 million in cash and raised $27 million in equity offering year-to-date giving a $75 million in cash before the impact of cash used in operating activities. This means that we will still need additional cash in the range of $15 million to $25 million for 2018, ” Uhh this assumes Deerfield removes the 25m threshold completely. We need 40m to 50m. The warrants wouldn’t cover this. Cjm. Don’t count on receiving money for the warrants until April 2019. Those holding warrants have an incentive built in to sell calls in Jan 2019 and then April 2019 before having to convert them if the stock is trading above 2.38
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Post by Deleted on May 10, 2018 8:08:11 GMT -5
Ok let’s assume sales pick up. Sales need to pick up to hit guidance. Hitting guidance still means 40m-50m more needed. Will the share price jump when/if sales jump? Will it jump enough to use warrants? We will have 150m outstanding shares at that point. 1b market cap will be under 7 bucks. Will publicizing select trials of the 65 help? Were those comparing afrezza to injectables? Will there be a trep partner this year after phase 1? That seems Early short interest is going to go back up as the cash decreases. If sales growth starts to accelerate in a greater and consistent fashion, that will start to drive share price. Current growth is inadequate. STAT study needs to have a dramatic and timely impact on Rx volume. Mike has also mentioned a cash program and such a program makes PA less of a hassle but the cash cost to the patient may or may not be a barrier. Part of what the market is trying to understand is if Afrezza will be commercially viable in the US. If it becomes clear the company will hit guidance and the growth rate will get the company to $150mm in 2019 then SP will respond. New HHS Secretary is Alex Azar. One of his mantras is value based medicine which supports the transition from fee for service to fee for outcomes which plays into the need for CGMs vs A1c. Adoption rate of fee for outcomes will be interesting. If we start to see the economy slow rapidly in late '18 / early '19 and the debt escalates at a more rapid rate (we just past $21T) value based (fee for outcome) medicine may take hold quicker than anticipated. www.forbes.com/sites/leahbinder/2018/03/08/surprisingly-bold-policy-speech-from-trumps-new-hhs-secretary/#2286c2fa1b6a
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May 10, 2018 13:12:37 GMT -5
Post by dreamboatcruise on May 10, 2018 13:12:37 GMT -5
Yes. Will the REMS removal and Stat study translate to more sales. If not it’ll be more dilution. The biggest impact of REMS was that the sales force had to mention it when detailing a new physician, but nothing more. I doubt it really had much of an impact on sales. STAT, due to its design, is set to deliver a positive message but it is a very small study that is not controlled and those don't change physician behavior much. Will those two items help? No doubt they will, but expect incremental improvements not hockey stick growth rates. The fact is that the company burns cash at rates that far exceed the increase in profit contribution from additional sales. They will be in cash raising mode for at least several more years. Due to the differences in pk/pd for Afrezza vs RAA, it would be nearly impossible to do a controlled blinded study that would be safe and allow optimizing outcomes for both an Afrezza arm and an RAA arm. Unless you see some way of doing that I don't. The size of the study is a valid point.
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May 10, 2018 13:17:55 GMT -5
Post by dreamboatcruise on May 10, 2018 13:17:55 GMT -5
Ok let’s assume sales pick up. Sales need to pick up to hit guidance. Hitting guidance still means 40m-50m more needed. Will the share price jump when/if sales jump? Will it jump enough to use warrants? We will have 150m outstanding shares at that point. 1b market cap will be under 7 bucks. Will publicizing select trials of the 65 help? Were those comparing afrezza to injectables? Will there be a trep partner this year after phase 1? That seems Early short interest is going to go back up as the cash decreases. If sales growth starts to accelerate in a greater and consistent fashion, that will start to drive share price. Current growth is inadequate. STAT study needs to have a dramatic and timely impact on Rx volume. Mike has also mentioned a cash program and such a program makes PA less of a hassle but the cash cost to the patient may or may not be a barrier. Part of what the market is trying to understand is if Afrezza will be commercially viable in the US. If it becomes clear the company will hit guidance and the growth rate will get the company to $150mm in 2019 then SP will respond. New HHS Secretary is Alex Azar. One of his mantras is value based medicine which supports the transition from fee for service to fee for outcomes which plays into the need for CGMs vs A1c. Adoption rate of fee for outcomes will be interesting. If we start to see the economy slow rapidly in late '18 / early '19 and the debt escalates at a more rapid rate (we just past $21T) value based (fee for outcome) medicine may take hold quicker than anticipated. www.forbes.com/sites/leahbinder/2018/03/08/surprisingly-bold-policy-speech-from-trumps-new-hhs-secretary/#2286c2fa1b6aMedicare already has performance based fees, but unfortunately the way they are structured does not reward minimizing long term progression of a disease such as diabetes. It is focused on short term outcomes and cost containment.
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May 10, 2018 14:12:40 GMT -5
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Post by cjm18 on May 10, 2018 14:12:40 GMT -5
Some people are thinking the deerfield 25m requirement is waived based on the quote from my original post. The 10k still Mentions it.
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May 10, 2018 14:36:24 GMT -5
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Post by cjm18 on May 10, 2018 14:36:24 GMT -5
“We also maintain our guidance for net cash used in operating activities in the $90 million to $100 million range. We started the year with $48.4 million in cash and raised $27 million in equity offering year-to-date giving a $75 million in cash before the impact of cash used in operating activities. This means that we will still need additional cash in the range of $15 million to $25 million for 2018, ” Uhh this assumes Deerfield removes the 25m threshold completely. We need 40m to 50m. The warrants wouldn’t cover this. Cjm. Don’t count on receiving money for the warrants until April 2019. Those holding warrants have an incentive built in to sell calls in Jan 2019 and then April 2019 before having to convert them if the stock is trading above 2.38 The warrants are only effective for 6 months. Until April 8th I believe.
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May 10, 2018 21:00:26 GMT -5
Post by traderdennis on May 10, 2018 21:00:26 GMT -5
Cjm. Don’t count on receiving money for the warrants until April 2019. Those holding warrants have an incentive built in to sell calls in Jan 2019 and then April 2019 before having to convert them if the stock is trading above 2.38 The warrants are only effective for 6 months. Until April 8th I believe. A group like Sabby can exercise the options on April 5th for delivery on April 19th if they are in the money. Or they use March instead of April to get almost the whole period in.
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