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Post by matt on Nov 15, 2019 16:20:25 GMT -5
Anvisa approves the drugs for sale, but CMED sets the maximum market price. If CMED follows their own rules as published, they have to come up with a reference price for Afrezza based on other insulins available in the local market, and those have an official price of $5-6 for 1000U. That would make importation of Afrezza a non-starter on price alone so Biomm has to negotiate something different and that may not be an easy process. If Biomm accepts an initial PF that is too low, it is nearly impossible to raise it later.
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Post by matt on Nov 15, 2019 15:21:07 GMT -5
I don't know Brazilian law well enough to comment on how they handle samples, but all sales are price regulated and the PF price is the baseline from which all other prices are calculated. Based on an earlier application to "fast track" the approval, Biomm might be trying to get Afrezza categorized as an "incremental improvement" over regular insulin which is how various value-added insulins are priced (e.g. pre-filled injector pens). Last time Anvisa would not give them that treatment stating that only lispro and glargine qualified under that particular regulation.
I don't know what the continued hold-up is unless CMED is strictly applying the pricing rules for insulin to Afrezza and Biomm is trying to negotiate something different.
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Post by matt on Nov 15, 2019 7:40:55 GMT -5
I looked as well and did not find it either. Based on recent years, there will be one more update just before Christmas. Without a announced PF price, Biomm is unable to sell the inventory they already have on hand either to the retail pharmacies or the government controlled entities. That will but a damper on any future orders until an official price is released so the initial shipment in late September is probably all that is going to show up in the 2019 financials.
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Post by matt on Nov 8, 2019 15:06:34 GMT -5
Here's an interesting idea... What if Mannkind were to hire patient reps (one per targeted sales market) to focus just on patients as a way to coordinate and dovetail with medical/doctor reps. How many pateints could one rep see and instruct on dosing each year? Let's say 2 per day / 10 per week / 520 per year. Now let's say there are 25 targeted markets (I have forgotten how many there actually are at this point) and these reps go to doctors offices to spend time answering questions and teaching proper titration at the offices of prescribing doctors. I think their abiltiy to increase retention and to help with onboarding new patients would more than pay for itself. Wouldn't the FDA object to MannKind employees going beyond the label? If MannKind is severely limited in what it can say in commercials, patient reps would be too. Yes, FDA will get upset if the reps make product claims that are not on the label, but dose titration and proper usage in accordance with the label is fair game. As I recall either Sanofi or Mannkind hired diabetes nurse educators in the early days for this exact purpose. Getting any patient stabilized on any medication is often a trial and error process, and there is a lot that can be done without crossing lines that the FDA finds objectionable. The question is whether the additional marketing cost is justified by increased retention; if it is then great. However, I suspect continue lack of formulary coverage is a far bigger problem due to the very significant out-of-pocket expense incurred by the patient.
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Post by matt on Nov 8, 2019 8:51:14 GMT -5
That said, this is better than the Deerfield Convenants. Have you read the Deerfield Covenants and compared them to the new ones? The new ones aren't any better and, in some ways, are more harsh. The real measure of a lender's covenants is how they are applied in the case of a default, which seems likely to happen unless Afrezza revenue hits a point of inflection to exponential growth. Covenants are always written to create a huge hammer that can be used to pound the debtor into paying, but Deerfield applied theirs is a fairly reasonable way for a hard money lender. Will Mid-Cap be as reasonable or will they be significant worse because, make no mistake, they are also a hard money lender. The problem is that you can't know how tough a hard money lender is going to be until after the default, and by then it is too late to do anything about it.
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Post by matt on Nov 7, 2019 10:50:48 GMT -5
If this was a preliminary is there a date that a final must be filed by ? Yes, the 10-Q is due 40 days after the end of the quarter for accelerated filers (which MNKD is) plus a grace period if the filing date is on a weekend or holiday. Do the math and that works out to November 14. The auditors have likely reviewed and passed on the numbers published in the press release; that is pretty standard for any public company. The details in the footnote disclosures sometimes take an extra week or two. Quarterly filing only get a review which is a lot less involved than the annual audit.
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Post by matt on Nov 5, 2019 8:42:21 GMT -5
Yes, what benefit to UTHR to give up capital for a small stake, when it could be used to other immediate purposes? ^^^^ This. Most larger pharma companies don't take 5% stakes in small companies unless it comes with some sort of option to acquire the other 95% which is difficult to pull off in a publicly traded company (the strategy works very well with privately funded startups). A stake of that size doesn't buy UTHR anything they don't already have via the licensing deal. As MNKD's single largest customer, they can already significantly influence what happens in the company so why pay more than absolutely necessary?
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Post by matt on Nov 1, 2019 10:08:00 GMT -5
MNKD's beta is about 2.17, so it moves much more than the overall market. I understand that from day to day it may not seem like it, but when MNKD moves it moves. One can also look at the share price volatility implied through the MNKD options, and those are also high. At least, they are certainly not what I would call low. They are certainly generally much higher than, say, those for UTHR. That is a good way to look at it, although beta is normally calculated as a backward-looking number and the options market is based on forward-looking estimates. If you have a better crystal ball than others, you can make a lot of money in the options market. The thing to keep in mind is that beta giveth and beta taketh away; as an unbiased measure of statistical covariance it does not play favorites. When the broad market is moving up a high beta stock will move up in an exaggerated manner, but when the broad market is tanking then a high beta stock will tank harder. You can also get different beta results depending on whether you look at covariance with the S&P, the complete NASDAQ index, the NASDAQ Capital Market, or just biotech stocks traded on the Capital Market. It call comes down to the question "volatile relative to what?" and the base measure picked for the calculation will determine just how high the beta is. The math is relatively simple, the interpretation of results is a bit more tricky.
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Post by matt on Oct 31, 2019 8:03:07 GMT -5
UTHR and MNKD appear to be on track for commercialization in early 2021. Is there reason to believe royalty payments will be delayed by 6 or 9 months? The trial has to be completed, then FDA has to approve an ANDA for the new delivery method, then the product has to launch. Royalties are usually paid quarterly within a few weeks after the 10-Q or 10-K is published, all or which can delay the start of significant royalties. Even if the product launches in mid-2021 it is unrealistic to expect big royalty numbers for a few quarters because the royalty rates on most deals ramp based on cumulative sales; the early sales are low single digit numbers, followed by higher single digits, and if the product is a big commercial success the double digit royalties kick in later. None of those events happen instantly, but if the market likes the product then they do happen!
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Post by matt on Oct 22, 2019 15:15:59 GMT -5
Wholesale prices of Afrezza are higher than others and need to be because of higher manufacturing costs. How are rebates from MNKD - at an amount to keep the sales profitable - going to be able to offset the higher costs for insurance companies? Why on earth would insurance companies want to pay higher amounts ? Insurance wants to pay higher amounts because they keep a major portion of the rebates received by the PBM. When the insurance plan has a high deductible and high out-of-pocket limit, as with the "Bronze" Obamacare plans, higher drug costs at the pharmacy counter actually reduce the cost of providing insurance because the patient pays more in co-pays. In some cases, patients are better off paying cash via a discount pharmacy then they are paying the co-pay at the pharmacy (i.e. the co-pay is more than 100% of the true cost of the drug). This is especially true for generics; it is almost always better paying 100% in cash at a discounter (like Wal-Mart or Costco) than it is using your normal pharmacy that knows about your insurance coverage. However, what holds true for most drugs does not apply to Afrezza due to the large price difference between Afrezza and the best selling injectable insulins. If a diabetic is on Afrezza they are in danger of reaching the out-of-pocket maximum for the year and that is the point at which the insurance company actually starts to pay the true cost of care.
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Post by matt on Oct 21, 2019 8:05:29 GMT -5
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Post by matt on Oct 18, 2019 16:04:15 GMT -5
Can someone tell me how ask on "MNKD 01/17/2020 2 Put" is 2.86??
My account shows last trade was at $1.77, I sold them a while ago.
For what ever reason MNKD options, more than any other stock I own, attracts the loons who place after-hours options trades (both put and call) with absolutely out of touch prices (especially on the ask/call side). My guess is they are hoping to catch someone putting in a market order - please don't do that on this stock you will get burned. In any given day they will place the exact same ask price across multiple strikes on several expiration dates. I just don't get it. I can only postulate that every once in a while it works for them or surely they would stop doing it. The other reason you see crazy AH prices is due to the rules governing brokers. For a broker to make a market during normal trading hours they also have to agree to maintain a bid/ask in the AH session, but if the volume is light then the broker does not want to assign staff to babysit the trading desk. As the regular session closes they move the bid and ask far beyond any reasonable range and that way they are guaranteed that nobody will execute an order against their quote. The next day the broker simply resets the price a few minutes before the market opens and business as usual resumes.
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Brazil
Oct 16, 2019 15:44:26 GMT -5
Post by matt on Oct 16, 2019 15:44:26 GMT -5
Going back to the Brazil shipment - I'm not sure that Afrezza will need to be listed on a price book since the total shipment is going into their hospital system. If anyone needs to lists prices it will probably come from the hospitals. But, that's mytakeonit I don't think anybody has said that the Afrezza is going into the hospital system. Public healthcare is a shared expense between the national government and the various state governments, and hospitals are not in the business of dispensing drugs except for inpatients (that is the role of the Farmacia Popular). Even if it were the government purchasing the entire shipment, the price is still regulated by CMED and the government buys at roughly a 20% discount to the permitted PF price. Regardless of the buyer, Brazilian law requires CMED to set the PF and in most states even the hospitals are subject to ICMP and PIS taxes on the sale so Biomm must know the PF in order to properly charge for ICMP and PIS. The PF is the important price as all the others can be computed from that, and the importer cannot charge more than the PF (plus taxes) at the wholesale level.
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Post by matt on Oct 15, 2019 9:28:35 GMT -5
There are at least ten PDE5 inhibitors either on the market or in late stages of development, RT234 was one of the approved molecules and Adcirca is another. It is entirely possible that UTHR decided that vardenafil did not do the job well enough and opted to switch to tadalafil. PDE5 inhibitors have been around since the early 1990's but bioavailability from the oral forms has been a problem, something the new generation of drugs is designed to address. UTHR could be testing any of the late stage candidates for TS delivery.
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Post by matt on Oct 11, 2019 9:35:43 GMT -5
Yesterday a small amount of my shares (5%) went out on loan. Fidelity told me there is not much demand. Interest paid is at 2.0%. Rate paid at Fidelity dropped to 1.875% on Wednesday and 95% of my shares are NOT loaned out. I’m surprised since the last short interest report showed an increase of 1M shares. It more efficient for large shorts to borrow from brokers that hold a lot of shares in street name; it is better from the brokerage's standpoint to lend 100,000 shares at once from the street name pool than it is to lend 1,000 shares from each of 100 individual accounts because there is less paperwork to do (even if computers do most of the heavy lifting). Similarly, a lot of the discount brokers that offer "free trading" can do so because they have permission to loan out shares in exchange for "free" services they provide.
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