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Post by james on Jan 12, 2016 19:12:25 GMT -5
There is much discussion about what a potential TS development deal might look like. Arena Pharmaceuticals signed a deal today that may give a little insight to this discussion. In this case, Arena is receiving $7.5M upfront, ongoing development funding (unclear how much), and the potential for milestone payments of up to $262M as well as undisclosed amount of future royalties. This deal is for one class of compounds that Arena has discovered which is not yet reached clinical trials. I don't believe they have previously disclosed this opportunity. invest.arenapharm.com/releasedetail.cfm?ReleaseID=950026I don't intend to specifically equate this or the amounts to expect with TS, as the market size and confidence for success will be different with each TS opportunity. But, it may give some hint of how such a deal could be structured and put context around what could be expected. ARNA is up about 18% today (10% after hours following the release). |
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Post by mnkdmorelong on Jan 12, 2016 19:43:58 GMT -5
The up front payment of $7.5 mln would not put a dent into MNKD's cash needs. Time is of the essence; MNKD cannot wait for milestone payments or royalties. MNKD may trade later payments for more up front cash.
But I agree that the ARNA term sheet looks like what MNKD would fetch in a TS deal.
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Post by james on Jan 12, 2016 20:06:38 GMT -5
Quite. $7.5M would be worth a month to MNKD. Management would certainly be hoping for larger amounts, maybe that's possible, maybe not. But there are a few distinct positives here and parallels to TS.
First, this is for a class of compounds that has not been tested in humans. Those suggesting the value of TS is zero because there is no approved product should take note. This particular undeveloped opportunity might be worth $50-100M or so in a speculative sense. TS is suggested to have 4 or more of these in the works.
Second, cash burn is a critical issue for MNKD. This deal includes development funding, the amount is not disclosed, but securing the same would be a key issue to extending the operating window for MNKD and lowers the amount of capital that would need to be raised. This is further helped if some of those milestones could be reached in the first year or two.
Lastly, some suggest that because Afrezza has not succeeded so far commercially, that no one would partner a TS deal. Well, Arena's only commercial product is Belviq, which has not done so hot. Arena is pursuing a strategy of targeting 'GPCR' receptors with their compounds. Belviq and these new compounds for CNS receptors hail from a similar concept, but interest obviously remains.
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Post by mnkdmorelong on Jan 12, 2016 20:19:42 GMT -5
Quite. $7.5M would be worth a month to MNKD. Management would certainly be hoping for larger amounts, maybe that's possible, maybe not. But there are a few distinct positives here and parallels to TS. First, this is for a class of compounds that has not been tested in humans. Those suggesting the value of TS is zero because there is no approved product should take note. This particular undeveloped opportunity might be worth $50-100M or so in a speculative sense. TS is suggested to have 4 or more of these in the works. Second, cash burn is a critical issue for MNKD. This deal includes development funding, the amount is not disclosed, but securing the same would be a key issue to extending the operating window for MNKD and lowers the amount of capital that would need to be raised. This is further helped if some of those milestones could be reached in the first year or two. Lastly, some suggest that because Afrezza has not succeeded so far commercially, that no one would partner a TS deal. Well, Arena's only commercial product is Belviq, which has not done so hot. Arena is pursuing a strategy of targeting 'GPCR' receptors with their compounds. Belviq and these new compounds for CNS receptors hail from a similar concept, but interest obviously remains. TS's value is it's unique features. It is an inhaled excipient that enables drug molecules to be absorbed through lung tissue. There is high vascularity in the lung (for obvious reasons) which allows a TS enabled drug quick access to the blood stream. Also different forms of drugs can be used; example: Afrezza is a lower molecular weight insulin that give rise to it's fast in and fast out feature. What drugs can benefit from these features? Pain meds? Epinephrine? Is speed all that important? The failure of Afrezza points to the ugly possibility that people don't want to inhale their drugs. TS has value; but it has fallen with the entire Afrezza franchise. We should know more tomorrow. |
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Post by liane on Jan 12, 2016 21:11:26 GMT -5
What drugs can benefit from these features? Pain meds? Epinephrine? Is speed all that important? The failure of Afrezza points to the ugly possibility that people don't want to inhale their drugs. TS has value; but it has fallen with the entire Afrezza franchise. I think you are seriously jumping the gun on your conclusions. |
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Post by mnkdmorelong on Jan 12, 2016 21:21:01 GMT -5
What drugs can benefit from these features? Pain meds? Epinephrine? Is speed all that important? The failure of Afrezza points to the ugly possibility that people don't want to inhale their drugs. TS has value; but it has fallen with the entire Afrezza franchise. I think you are seriously jumping the gun on your conclusions. I have made no conclusions; I make inferences from actions. It has been over a year since the SNY deal and there is no TS deal. If companies were chomping at the bit to get into TS, something would have happened already. We should know more tomorrow. |
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Post by sweedee79 on Jan 13, 2016 3:06:07 GMT -5
TS's value is it's unique features. It is an inhaled excipient that enables drug molecules to be absorbed through lung tissue. There is high vascularity in the lung (for obvious reasons) which allows a TS enabled drug quick access to the blood stream. Also different forms of drugs can be used; example: Afrezza is a lower molecular weight insulin that give rise to it's fast in and fast out feature. What drugs can benefit from these features? Pain meds? Epinephrine? Is speed all that important? The failure of Afrezza points to the ugly possibility that people don't want to inhale their drugs. TS has value; but it has fallen with the entire Afrezza franchise. We should know more tomorrow.
Mnkd and Afrezza have not ran into problems because people don't want to inhale their drugs... Ive talked to many people with diabetes and not one of them has mentioned any concern about that and in fact were anxious to try it .. The problems with Afrezza are directly related to the label and FDA restrictions ... being unable to differentiate our product .. lack of public awareness ..lack of support by medical professionals..... lack of knowledge about what Afrezza is .. Sanofis failure to start superiority studies... etc etc etc...
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Post by mnkdmorelong on Jan 13, 2016 6:33:16 GMT -5
TS's value is it's unique features. It is an inhaled excipient that enables drug molecules to be absorbed through lung tissue. There is high vascularity in the lung (for obvious reasons) which allows a TS enabled drug quick access to the blood stream. Also different forms of drugs can be used; example: Afrezza is a lower molecular weight insulin that give rise to it's fast in and fast out feature. What drugs can benefit from these features? Pain meds? Epinephrine? Is speed all that important? The failure of Afrezza points to the ugly possibility that people don't want to inhale their drugs. TS has value; but it has fallen with the entire Afrezza franchise. We should know more tomorrow.
Mnkd and Afrezza have not ran into problems because people don't want to inhale their drugs... Ive talked to many people with diabetes and not one of them has mentioned any concern about that and in fact were anxious to try it .. The problems with Afrezza are directly related to the label and FDA restrictions ... being unable to differentiate our product .. lack of public awareness ..lack of support by medical professionals..... lack of knowledge about what Afrezza is .. Sanofis failure to start superiority studies... etc etc etc...
How important is the label? Is this holding Afrezza back? Posters on this Board do not realize that the ambit of the label goes no further than the drug company. The FDA controls how the product is made, the label, and how Afrezza is marketed. The FDA has no control over the docs who can say whatever they want about Afrezza. Or prescribe it in any way they think is appropriate. The FDA has no control over the patient who acts on "off label" information he or she received from her doc or from the web. You don't see the FDA shutting down Sam Finta's web site or any other website even though the information is off label. The FDA will shut down fraudulent website; But Sam and others are just telling their story. I and many others thought that Afrezza's rapid on and rapid off feature is a killer app that diabetics would rush to get a hold of. Clearly this has not happened. Sam Finta is an early adopter. How long will it take the great diabetic masses to use Afrezza if at all. My hope is once the price is "right-sized", diabetics will give Afrezza a shot. |
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Post by mnholdem on Jan 13, 2016 8:31:51 GMT -5
I think you are seriously jumping the gun on your conclusions. I have made no conclusions; I make inferences from actions. It has been over a year since the SNY deal and there is no TS deal. If companies were chomping at the bit to get into TS, something would have happened already. You seem to forget that it was only recently that MannKind Corporation started its pipeline development after suspending pipeline activities following the 2nd CRL in 2013. Setting aside the time that it took for the API-selection process (for which management hired a consulting firm) you make it sound like simply turning on a light switch at a retail store with a neon sign flashing "Open" for business, with all your 2016 models on display in the store window.
If you want to attract a pharmaceutical partner, simply saying, "Hey, you can inhale this stuff!" just isn't going to cut it. You had better have some solid pre-clinical data and statistics related to unmet medical needs on hand to negotiate with. This is the kind of activity (action) that management was referring to when they stated that they have about 30 employees working on pipeline development.
Finally, your remark of "something would have happened already" is woefully oblivious to the possibility that many things are happening already. Hakan Edstrom recently stated that API(TS) discussions are active and that MannKind will have updated information on its API(TS) partnership activity by the end of Q1. Hakan originally stated by the end of the year, but immediately corrected himself, saying, "sorry, the end of next quarter". (I suspect that Matt will make some disclosures today, simply to prevent class-action lawyers from being able to use Hakan's comments against the company. If Matt updates TS partnership activity at the conference today, he will have fulfilled Hakan's "promise" to deliver a partnership update.)
It's frustrating, from shareholders' perspective, that MannKind Corporation is not disclosing details about all actions that are occurring related to its pipeline development. That doesn't mean that nothing has or is happening.
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Post by mnkdmorelong on Jan 13, 2016 9:04:00 GMT -5
I have made no conclusions; I make inferences from actions. It has been over a year since the SNY deal and there is no TS deal. If companies were chomping at the bit to get into TS, something would have happened already. You seem to forget that it was only recently that MannKind Corporation started its pipeline development after suspending pipeline activities following the 2nd CRL in 2013. Setting aside the time that it took for the API-selection process (for which management hired a consulting firm) you make it sound like simply turning on a light switch at a retail store with a neon sign flashing "Open" for business, with all your 2016 models on display in the store window.
If you want to attract a pharmaceutical partner, simply saying, "Hey, you can inhale this stuff!" just isn't going to cut it. You had better have some solid pre-clinical data and statistics related to unmet medical needs on hand to negotiate with. This is the kind of activity (action) that management was referring to when they stated that they have about 30 employees working on pipeline development.
Finally, your remark of "something would have happened already" is woefully oblivious to the possibility that many things are happening already. Hakan Edstrom recently stated that API(TS) discussions are active and that MannKind will have updated information on its API(TS) partnership activity by the end of Q1. Hakan originally stated by the end of the year, but immediately corrected himself, saying, "sorry, the end of next quarter". (I suspect that Matt will make some disclosures today, simply to prevent class-action lawyers from being able to use Hakan's comments against the company. If Matt updates TS partnership activity at the conference today, he will have fulfilled Hakan's "promise" to deliver a partnership update.)
It's frustrating, from shareholders' perspective, that MannKind Corporation is not disclosing details about all actions that are occurring related to its pipeline development. That doesn't mean that nothing has or is happening.
Deals in any walk of life follow a certain timing pattern. Similar to dating; either it goes to the next level or it doesn't. The first post on this thread is what a TS deal should have looked like and entered into last year. It's a joint development agreement with no promises. A potential suitor must pay for MNKD's time in development. All the preclinical testing is done under the agreement. Nobody expects MNKD to do all this work on their dime with an API that does not belong to them. Certainly today's meeting would be perfect to announce a TS deal. But it should have been preceded by a press release this morning which did not happen. It looks like the best we can get is an update. But updates do not pay the bills. |
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Post by kball on Jan 13, 2016 9:08:21 GMT -5
I have made no conclusions; I make inferences from actions. It has been over a year since the SNY deal and there is no TS deal. If companies were chomping at the bit to get into TS, something would have happened already. You seem to forget that it was only recently that MannKind Corporation started its pipeline development after suspending pipeline activities following the 2nd CRL in 2013.
-snip-
If you want to attract a pharmaceutical partner, simply saying, "Hey, you can inhale this stuff!" just isn't going to cut it. You had better have some solid pre-clinical data and statistics related to unmet medical needs on hand to negotiate with. This is the kind of activity (action) that management was referring to when they stated that they have about 30 employees working on pipeline development.
Finally, your remark of "something would have happened already" is woefully oblivious to the possibility that many things are happening already.
-snip-
If Matt updates TS partnership activity at the conference today, he will have fulfilled Hakan's "promise" to deliver a partnership update.)
Do we have any indication or confirmation that the pipeline people still number approximately 30? I'm wondering if the 3 rounds of layoffs (and the additional upcoming round i think is reasonable to expect given the company's situation) might have cut that number, perhaps substantially. Another question i hope that Matt addresses in his JPM talk. It may be the only thing he can actually speak to and say something without having legal crawl up his bum |
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Post by peppy on Jan 13, 2016 9:15:55 GMT -5
You seem to forget that it was only recently that MannKind Corporation started its pipeline development after suspending pipeline activities following the 2nd CRL in 2013.
-snip-
If you want to attract a pharmaceutical partner, simply saying, "Hey, you can inhale this stuff!" just isn't going to cut it. You had better have some solid pre-clinical data and statistics related to unmet medical needs on hand to negotiate with. This is the kind of activity (action) that management was referring to when they stated that they have about 30 employees working on pipeline development.
Finally, your remark of "something would have happened already" is woefully oblivious to the possibility that many things are happening already.
-snip-
If Matt updates TS partnership activity at the conference today, he will have fulfilled Hakan's "promise" to deliver a partnership update.)
Do we have any indication or confirmation that the pipeline people still number approximately 30? I'm wondering if the 3 rounds of layoffs (and the additional upcoming round i think is reasonable to expect given the company's situation) might have cut that number, perhaps substantially. Another question i hope that Matt addresses in his JPM talk. It may be the only thing he can actually speak to and say something without having legal crawl up his bum This patent filed today; Methods and compositions for treating pain incorporates every prior patent. My theory is Hakan working on the technosphere side. www.freepatentsonline.com/9233159.html unreadable, scroll down.
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Post by suebeeee1 on Jan 13, 2016 9:20:36 GMT -5
Do we have any indication or confirmation that the pipeline people still number approximately 30? I'm wondering if the 3 rounds of layoffs (and the additional upcoming round i think is reasonable to expect given the company's situation) might have cut that number, perhaps substantially. Another question i hope that Matt addresses in his JPM talk. It may be the only thing he can actually speak to and say something without having legal crawl up his bum This patent filed today; Methods and compositions for treating pain incorporates every prior patent. My theory is Hakan working on the technosphere side. www.freepatentsonline.com/9233159.html unreadable, scroll down.
Richard Houghton, one of the inventors listed on this patent, works for Torrey Pines. Expect a Torry Pines partnership. Unfortunately, I don't see Torrey Pines bringing a high up front payment to the table. |
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Post by peppy on Jan 13, 2016 9:29:02 GMT -5
This patent filed today; Methods and compositions for treating pain incorporates every prior patent. My theory is Hakan working on the technosphere side. www.freepatentsonline.com/9233159.html unreadable, scroll down.
Richard Houghton, one of the inventors listed on this patent, works for Torrey Pines. Expect a Torry Pines partnership. Unfortunately, I don't see Torrey Pines bringing a high up front payment to the table. Thank you Sue. IF, does that equal = licensing agreement? I do not know and or understand their relationship.
added, I better understand now www.valuewalk.com/2015/06/mannkind-pain-management/
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Post by matt on Jan 13, 2016 9:30:01 GMT -5
Most drug delivery deals have a small upfront payment, much of which is used to advance the technology further or to complete trials or other work needed to commercialize the partnered drug. While a little bit of the money that comes in along the way may hit the bottom line, most is to support the development.
The big payday comes when the drug does reach market. At that point the drug delivery partner is mostly out of the picture and can sit back and collected royalties during the remaining life of the patents which, depending on the drug, can be a very nice number. Alza made a killing with its extended delivery technologies that enabled many of the "once a day" oral medications. Success came, but it took many years to get there.
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