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Post by matt on Oct 2, 2020 7:20:37 GMT -5
Kind of a naive question, but can we do a deal with Dexcom where we drop their product in our bag to sell and they start selling Afrezza? Is this done anywhere? And if we can, what about the others? Those types of deals have happened now and again in the industry, and they are almost always dismal failures. CGM products are medical devices while Afrezza is a drug which means two different sets of regulatory requirements, sales force training, and production economics. Generally speaking, when you mix a pharmaceutical product in the same sales bag with a device you get the worst of both worlds rather than the best. If you really want to nit pit, Dexcom is not even a traditional medical device but rather a diagnostic which again is a whole different animal. The other issue for Dexcom is that Afrezza is a tiny part of the insulin market. MNKD does less than 1,000 scripts a week while the two best selling analogs do more than 250,000 per week. If Dexcom is going to play favorites and partner with a single product for a co-promotion deal, they are also going to be shutting the door on the other insulin producers. That logic may work if the partner is Lilly or Novo, but the numbers are not going to work out very well if the partner is MNKD. The reality is that in 99% of the cases device companies and pharma companies should have precious little to do with each other. The value in almost any partnership accrues mainly to the partner that controls access to the therapeutic rather than the diagnostic. Dexcom has little incentive to handcuff itself to any drug company because in that scenario they are going to wind up with the short end of the stick. If Dexcom wants to maximize its own value they are better selling themselves to another medical device company for whatever price they can get. Any of the broad line device or diagnostic companies would be decent fit (Medtronic, GE Healthcare, Philips, Siemens, or Roche Diagnostics immediately come to mind on less than one cup of coffee). Roche, in particular, has a lot of small diagnostic devices for use in point-of-care environments, and Philips has very strong access to consumer marketing channels. |
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Post by matt on Oct 1, 2020 8:13:04 GMT -5
I can’t wait! You know my plan, load up before the run-up to TrepT FDA approval. Just make sure you take your profits when you can. The big bumps that accompany most biotech approvals do not last for more than a day or two, sometimes only hours, so the winning strategy is almost always to load up at lower prices in anticipation of the event and unload into the news wave. If you are still optimistic about the approval, you can normally reload at a lower price in the following weeks. This is probably doubly true with TreT because the drug is already out in the market. Unlike a truly new drug for an unmet clinical condition that creates instant demand, TreT is an alternative formulation that will take a few quarters to catch fire as patients are switched over. |
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Post by matt on Sept 28, 2020 10:55:34 GMT -5
If you read the fine print you will see that Yahoo does not publish their own data, they buy data in bulk from various vendors and then republish it. The same is true of Google and Microsoft financial data; they are not the originator of the feeds. Yahoo says: - Financial statements, valuation ratios, market cap and shares outstanding data provided by Morningstar.
- Company profile data provided by S&P Global Market Intelligence.
- US equities and global index historical data and daily updates provided by Commodity Systems, Inc
- International historical chart data and daily updates provided by Morningstar.
- Analyst estimates, earnings, corporate, economic events, IPO, and insider transactions data provided by Refinitiv*.
- Top institutional and mutual fund holders provided by Vickers-stock.com.
- SEC Filings, primary financials, and insider transactions data is provided by EDGAR Online, a division of Donnelley Financial LLC.
- Sustainability data provided by Sustainalytics and Morningstar.
- Upgrades and downgrades provided by Benzinga.
- Corporate governance scores provided by Institutional Shareholder Services.
In turn most of those services use computer algorithms to publish their feeds; it is not like there is an experienced analyst that studies each stock and makes a forecast. Those services are available, but not for free. Lack of a forecast likely means that the algorithm did not have all the data points it needs to create an automated forecast, or that one of the data points was either negative (when a positive is expected) or zero (creating a mathematically meaningless divide by zero condition; computers don't like it when that happens).
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Post by matt on Sept 22, 2020 16:37:17 GMT -5
Why not issue a $0.05 dividend if we're still as undervalued as we are today? Because issuing a dividend is, quite literally, illegal at this time. A company is owned by its shareholders, but also by its creditors which is why the company has to maintain a detailed balance sheet to record who owns what. Dividends can only be paid from retained earnings and as of the last quarter, the was a negative balance in retained earnings of more than $3 billion. While some of that hole can be eliminated by a wholesale recapitalization of the company (there are various legal maneuvers to get there), at a minimum paying a dividend requires enough cash flow to liquidate all the outstanding liabilities before shareholders get dividends. Dividends are a payment of earnings (of which there are none) and any other type of distribution is considered a reduction of paid capital. So long as there is material debt on the books, reducing paid capital is considered a fraudulent conveyance, at which point a platoon of lawyers get involved and a whole bunch of bad things happen. Not worth it for a nickel! |
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Post by matt on Sept 21, 2020 7:43:06 GMT -5
Big question is who is making it? The patent holder on this drug is Relief Therapeutics, a Swiss company. I don't know who does the actual manufacturing but normally the contract manufacturer used is of little importance. NeuroRx has partnered with Relief Therapeutics to commercialize the drug for the US market. I don't think this drug has much potential for early use outside the hospital setting. If a patient has COVID or any other inflammatory promoter that triggers a cytokine storm, then they belong in the hospital (at a minimum) and preferably in the ICU. These are very sick people. |
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Post by matt on Sept 16, 2020 10:56:00 GMT -5
Is MNKD able to do the phase 1 for Sumatriptan Technosphere® on it's own? I think this is the most likely non-UTHR molecule to get traction Phase I trials are generally limited to safety with no indication of efficacy at all. Phase II trials are generally dose escalation protocols, which find the range(s) of dosages needed to create a therapeutic effect and sometimes provides limited efficacy data depending on how large the cohorts are. Phase III is the largest where patients with the disease condition are treated for signs of efficacy and to reveal side effects not detectable in the Phase I population. Phase I trials, especially with approved drugs, are often tiny or are skipped entirely. Can MNKD afford a limited scope Phase I trial, which would only require 15-20 healthy subjects? Almost certainly. Would such a trial get anybody excited? Unlikely, because that trial would be performed with a proven drug and a proven delivery system. Indeed, it would be only be remarkable if Phase I failed miserably precisely because the risks involved are so minimal. A more likely scenario would be to do a combined Phase I/II trial on a larger cohort, say 100 patients, which could provide insight into dosing requirements and some indication of efficacy. That trial, while making a lot more economic sense, would be a fairly expensive exercise that would likely be too rich for MNKD to undertake without a partner. What MNKD can afford to do on their own would provide such a limited amount of data that doing such a trial is not a good use of the money. Conversely, if a trial has enough patients and collects enough data to provide meaningful results then it is probably more expensive than what MNKD itself can afford. Rock meet hard place. |
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Post by matt on Sept 10, 2020 15:32:11 GMT -5
Yep, one more nail into the short coffin. I think a good range to have bought in was at 82 cents, 88 cents, and $1.16  But, that's mytakeonit ...and you can confidently expect that they did. Their aim is buy low sell heavily at the peak, close the short at the low, reload, repeat. They don't really care where the high and low is, they just trade the channel. While the stock remains range-bound on a nice wide range they will keep doing it. Exactly right, and the balance sheet pretty much guarantees another two years of dilution before we can see what the UTHR relationship will really deliver in terms of royalties. Until then, the company will held hostage by MidCap and the debt covenants which could mean the need for maintaining the $40 million in free cash, and/or some other penalty yet to be defined. Regardless, the cash on the balance sheet can't be used to fund operations if it has to be held in reserve for MidCap and the continued negative cash flow from operations has to be funded. That is a dream for a swing trader. |
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Post by matt on Sept 9, 2020 18:11:15 GMT -5
During business hours, yes. But the happy hours on Friday after the clinic closes are epic. Matt showing a humorous side for the first time. Good things on the horizon for mnkd stock . Not the first time. You don't get copied on some of my private messages  |
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Post by matt on Sept 8, 2020 16:05:38 GMT -5
Is the hot tub only for customers? During business hours, yes. But the happy hours on Friday after the clinic closes are epic. |
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Post by matt on Sept 7, 2020 8:42:26 GMT -5
How can it take seven years to award a patent? It doesn't usually take that long, but it can. The patent goes through an application stage where the examiner checks it to ensure that it meets the minimum legal requirements, and then the proposed patent is published publicly so that others can file an objection, and finally it is granted. Any of those three steps can incur delay, and some patent examiners are more backed up than others. As you might imagine, the patent examiners that approve patents for new electronic devices are necessarily different from those that pass on biologic discoveries. Often the delay is caused by the applicant doing a sloppy job at the first stage and failing to include all the information necessary for the examiner to reach a conclusion on the patentability of the invention, and this requires a series of letters back and forth between the examiner and the applicant with each letter exchange taking time. Similarly, if many parties file objections to a pending patent those all have to be adjudicated before the patent can issue. |
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Post by matt on Sept 3, 2020 14:11:29 GMT -5
Bottom line is it’s dilutive. form of executive and employee compensation is dilutive to shareholders; it is just a question of what mix of guaranteed income and incentive compensation a company wants to have. Too much of either one can create the wrong incentives. The real problem is that shareholders are unhappy with the performance of the company; if MNKD was outperforming the market consistently year after year would anybody care if Mike & friends had a nice stock incentive as a reward? The restricted stock is not the problem, the lack of performance is. |
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Post by matt on Sept 1, 2020 8:08:50 GMT -5
Okay, then please explain what the percentiles refer to. Why would percentiles even be mentioned, if it was a straight comparison to the TSR of the index? This looks fairly straightforward to me. It compares "total shareholder return" which is generally defined as stock price appreciation plus cash dividends (you have to read the fine points of the plan to verify that). If MNKD performs about as well as the firms in the Russell index, the executives will get a 100% payout. While it is fun to talk about the payouts at the 300% level, the fact is that most companies in the Russell that are in the 90% percentile have hit a home run and been acquired at a huge premium by some other company, just like most of the ones in the bottom 25% have suffered multiple business issues (failed clinical trials, product recalls, lawsuits) such that they are nearing bankruptcy or have already gone out of business. Since most small pharmas pay no dividend, share price appreciation is the primary driver of TSR. The plan does not provide a payout based on what MNKD does, it provides a payout based on what MNKD does relative to its peer group. Beat the averages and the payout is bigger, but fail to beat the average and the payout gets smaller. A better question is whether a 100% payout is justified for being average relative to the peer group when the folks that put together the Russell index are picking the components of the index rather than the board itself. |
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Post by matt on Aug 26, 2020 10:22:45 GMT -5
Not how I read it. If they have $40 M unrestricted cash available, then whatever Afrezza sales they post, even if under the minimum cap, does not constituie a breach of the terms and they can borrow as if they meet the terms. That is not what the amendment says. To fully understand it, you need to go back to the original agreement and the first amended agreement and then finally this second amendment to understand how all of this goes together. In particular, you need to read the definition of default under Section 10 of the original agreement, and the remedies provided to the lender. In short, as with most credit agreements, if a borrower defaults then the lender can declare the loan immediately due and payable together with accrued interest. As a practical matter, most lenders will not declare a borrower in default preferring to squeeze additional payments or concessions out of the borrower because a declaration of default would likely trigger an avalanche of undesirable legal ramifications. These include automatic suspension of the right to raise money under the S-3 registration statement (including the ATM facility) until the next 10-K is filed, and triggering of cross-default provisions which exist in practically every credit agreement (i.e. default on one obligation automatically puts all other obligations in default). Declaration of default by a lender frequently guarantees an immediate filing in bankruptcy court and if that happens everybody becomes a loser, including the lenders, so everybody tends to play nice despite the availability of harsh legal remedies. The amendment grants a waiver of default for failure to reach the required Afrezza minimum sales covenant until November 30, 2020 if the company maintains unrestricted cash of $40 million. That is all the amendment provides; a waiver of the specific financial covenant contained in Section 9.1 in exchange for the higher minimum cash balance. It does not grant a waiver of the minimum sales for the purposes of borrowing additional tranches as that would required a separate amendment to the "Credit Facility Schedule". The scope of the amendment must be read narrowly in accordance with its terms. |
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Post by matt on Aug 24, 2020 7:24:38 GMT -5
It will be interesting to see how this goes. UTHR are unlikely to be able to block, or even slow Liquidia, because UTHR's case is based on the continuation patents of an invalidated patent (courtesy of SteadyMed). Once the continuation patents are invalidated as well then the UTHR lawsuit is over. The lawsuit makes sense because if, against all the odds, the patent is not invalidated UTHR want to be in a position to block Liquidia. UTHR would have difficulty buying Liquidia because the agreement with Mannkind specifically forbids this: During the Term, neither United Therapeutics nor any of its Affiliates (subject to Section 15.10) shall develop, manufacture or commercialize, or authorize any Third Party to develop, manufacture or commercialize any product (other than Product) containing or comprising any dry powder formulation of API that is or is intended to be primarily administered in or through the lungs.
This all comes down to how nice Liquidia wants to play. They can split up the market with UTHR, or they can compete on price and become the favored drug in the formularies. My bet is that both sides would rather keep the price high and split the market between them. I don't think the existing agreement between UTHR and MNKD would pose any barrier at all to a Liquida deal. Section 12.3(a) of that agreement also specifies this: "United Therapeutics shall have the right to terminate this Agreement in its entirety or with respect to (i) a Development Plan or (ii) any particular Product, at any time for any reason or for no reason upon delivery of at least 90 days’ prior written notice to MannKind."That sentence is pretty much boilerplate language for any drug development agreement; the guy writing the biggest checks can always walk away just like Sanofi did when they terminated the distribution agreement several years ago. The 90 day notice period is almost a joke since it would take UTHR and Liquida that long to complete closing formalities on a transaction. What it really comes down to is how much UTHR would have to pay for Liquida and the perceived value of keeping a competitor out of the market for some period of time. It also comes down to the question of who has the best delivery technology which would pit Technosphere against the Liquida technology. My guess is that they are both reasonably effective and that there would be no clear winner in a head-to-head duel which brings the analysis back to the competitive landscape. I agree with you that once SteadyMed invalidated the underlying patent the legal strategy of blocking Liquida based on a CIP was doomed to the point that it might get decided on a summary judgment; Liquida will have to be dealt with in the market. Of course if UTHR terminates the contract then MNKD could still commercialize its product that it can find a source for the API, which probably is not a big deal, provided it can find a new partner willing to take on UTHR as the cost of rerunning the clinical studies would be beyond the ability of MNKD to fund by itself, not to mention the cost of market launch. I think we are about to find out how much UTHR values market exclusivity for an additional two or three years. |
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Post by matt on Aug 18, 2020 14:32:25 GMT -5
Can anyone shed some light on whether the UT press release implies royalties to MNKD would begin prior to 2022? The press release did not suggest royalties earlier than 2022. The relevant language is this: ". . . New Drug Application (sNDA) for Tyvaso® (treprostinil) Inhalation Solution for the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD)." Note that it explicitly calls out the solution form of Tyvaso and not the powered form. This is not surprising since UTHR has been marketing Tyvaso in solution for a long time and it is the form of delivery with which UTHR and its clinical centers have the most experience. That translates directly into a faster path through FDA. This is a supplemental application to add ILD as a treatment to the exist label for Tyvaso which is a far simpler process to manage that to try and license a drug for a new disease at the same time as a new formulation. The winning strategy for any drug manufacturer is to get the indications expanded first, then to add different delivery mechanisms. This also implies that there will be more than one formulation available and that the market price of a powered inhaler will matter to the uptake with managed care companies. It is unrealistic to assume that all Tyvaso patients will immediately be switched to TreT because many physicians are unwilling to alter a therapy choice that has been working and Tret may not provide equivalent results for all patients. Similarly, while there are a lot of patients that could potentially benefit from a powered version for treating PAH, there needs to be clinical evidence that the powdered form is equivalent in efficacy to the solution form. Assuming this is the case (it is always dangerous to assume that a trial will turn out as hoped) some patients will get switched to the powered version and some will not. A lot will depend on the clinical data and that will not be available for some time. Likewise, do not forget that Liquida is moving ahead with its dry powdered formulation so by the time TreT hits the market it will likely have a direct competitor along with the liquid versions of treprostinil. Because Liquida is applying for approval under the 505(b)(2) pathway, whatever indications UTHR has approval for will also extended to the Liquida product. That makes the tea leaves difficult to read regarding timing and amount of future royalties, but material royalties are not likely in 2021. |
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