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Post by mnkdmorelong on Jan 15, 2016 10:54:20 GMT -5
no I have never been on a call with sales reps at physician offices. I have had sales reps teach how to use equipment after if was purchased by the purchasing dept. Mnkdmoreshort, as a rule I do not care to be in health care facilities. However, over the years I have been at physicians offices, with children. The rep comes in and is stopped cold at the front desk. They drop off samples. The physicians know the gig, so many drugs, so many reps. So many conflicts of interest. You see a few sales reps drop off samples and assume that scenario applies to all reps? Why would you even write this? You really don't know.
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Post by mnkdmorelong on Jan 15, 2016 10:32:20 GMT -5
I agree with you. Dr. Urbanski's comment has more to do with MNKD's lack of cash than the actual method. Doctors are very busy people and the like the system where salespeople call on them to advise them of new products. Right in their office. Needless to say, the salesperson must not waste the doc's time. This is why salespeople love new products. It allows them to present something new to the doc. A dedicated sales force is very very costly and inefficient. But it seems to be working. Without an Afrezza advocate in front of the doc next to SNY and NVO, who do you think is going to win? Social media is new, inexpensive, and alluring for its reach. But MNKD must be careful as they are responsible for the message and if that is garbled, they will hear from the FDA. The sales people are talking to person at the front desk. The physicians are busy.
Ex Drug Rep -- Manipulating Doctors www.youtube.com/watch?v=kOW8LNU2hFE
Peppy, you have never been on a sales call with a rep. This is the real world. Keep in mind, the salesperson knows not to waste anyone's time. A good salesperson comes in and checks in at the front desk. Then they go to the nurse's station and make sure their product is working and generally making sure all are feeling the love. It is there that they enquire about docs. Who is busy. "Can I get 10 minutes with Dr. Smith to show him a new product." So on and so forth. The salesperson who waste time sits in the waiting room. The best ones are so well known and have such a relationship that they just enter the practice and go the the nurse's station. A good salesperson is a valuable resource to the practice. Of course there are bad salespeople. And they move from job to job. They would be available to MNKD for their own salesforce. This would not be good.
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Post by mnkdmorelong on Jan 15, 2016 10:10:22 GMT -5
Dr. Urbanski said Sanofi was using an outdated means to sell Afrezza. But I am concerned if that's a rationalization since we don't have resources to do it that way anyway. Blocking and tackling is never outdated. And neither is a drug salesperson talking face to face with a drug prescriber. Thoughts? I agree with you. Dr. Urbanski's comment has more to do with MNKD's lack of cash than the actual method. Doctors are very busy people and the like the system where salespeople call on them to advise them of new products. Right in their office. Needless to say, the salesperson must not waste the doc's time. This is why salespeople love new products. It allows them to present something new to the doc. A dedicated sales force is very very costly and inefficient. But it seems to be working. Without an Afrezza advocate in front of the doc next to SNY and NVO, who do you think is going to win? Social media is new, inexpensive, and alluring for its reach. But MNKD must be careful as they are responsible for the message and if that is garbled, they will hear from the FDA.
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Post by mnkdmorelong on Jan 14, 2016 16:20:38 GMT -5
There are three drug candidates for TS under consideration. Palonsetron (for Chemo), Epinephrine, and a third for pulmonary hypertension. All three put together are only a fraction of the insulin market. Except for Epinephrine, the drugs will have full clinical trials. Missing from the list is MNKD's pain med. Also missing are large volume drugs. I think this is why it has taken so long to get a TS deal. MNKD went through the list of high volume drugs and found no buyers. Now they are down to the orphan drug volume level. I can't see any of the opportunities generating a large up front payment. MNKD needs cash now. Was hoping some of the more established docs could speak up to what they think about the potential here. I find myself in the same camp, unfortunately. All of the medications on here are already on the market, some in somewhat cheap formulations. I thought I remembered seeing vancomycin on the list? This would be helpful because they wouldn't require an IV, but aren't patients usually admitted anyway if they're infected with an agent that would require them to take it? I don't know enough to know if it would be as simple as writing a script and then allowing them to go home. It's one of those things that sounds good on paper, but doesn't really fill a need. Unless someone on here can speak up and correct me? Then, the vast majority of these are niche drugs. These are great to develop the pipeline, but horrible right now if we're counting on them to get us through our financial crisis. It sounds to me like Matt's greatest hope is that these will simply instill confidence in the company and raise the share price to do another offering. I didn't get the impression that he was counting too much on upfront payments, although I'm sure he's hoping for them ha. I was really hoping MNKD would develop their own novel medications. Really, after I think about it, there aren't too many medications that need quick absorption. Mainly cardiac related meds. Epi would be one of them, but as another posted added, it worked quickly in the pen. And I raised the issue in another thread that a few of the biggest problems with anaphylaxis is a swollen tongue/throat and difficulty breathing. I'm not really sure I would want to prescribe an inhaled medication as the sole means of treating anaphylactic shock. I think I'd still want a pen as a backup just in case they didn't take it soon enough before their tongue/throat swell, and bronchioles close up. Unless there is a study that shows it's just as effective under those scenarios... The value of the TS technology is that it can do something that has not been done before. Rapid in and out insulin is the example. If Epinephrine runs into a block airway issue and the standard of care (Epipen) works fine, then the opportunity is not crisp and compelling. I am sure analyst can do the calculus and value the novelty of the API/TS pair. Your take (and mine) is meh. Too many of these will degrade the value of MNKD.
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Post by mnkdmorelong on Jan 14, 2016 14:50:39 GMT -5
Interesting article. There is more to the failure than just an inept SNY. Lessons learned: In porting TS to another API, the sole benefit cannot be that it can be inhaled. The resistance to inhaled drugs is deep. No they (BP, Endos, needle manufactures, pen manufactures, etc, etc, etc,) are terrified of the potential and what it could do to their revenue. The conspiracy theory? Not true.
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Post by mnkdmorelong on Jan 14, 2016 14:19:26 GMT -5
Interesting article. There is more to the failure than just an inept SNY.
Lessons learned: In porting TS to another API, the sole benefit cannot be that it can be inhaled. The resistance to inhaled drugs is deep.
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Post by mnkdmorelong on Jan 14, 2016 12:41:17 GMT -5
The Danbury facility has got to be worth over $100 mln. It is used to securitize the Deefield loan of $74 mln? Is it possible to sell the plant to Deerfield, extinguish the debt, get cash out? This would open up money from the Mann group. MNKD would lease the buildings from Deerfield. That would be the last possible thing Mannkind would ever do. Why would they sell their crown jewel production facility? To get cash!
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Post by mnkdmorelong on Jan 14, 2016 12:29:05 GMT -5
The Danbury facility has got to be worth over $100 mln. It is used to securitize the Deefield loan of $74 mln?
Is it possible to sell the plant to Deerfield, extinguish the debt, get cash out? This would open up money from the Mann group. MNKD would lease the buildings from Deerfield.
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Post by mnkdmorelong on Jan 14, 2016 11:09:11 GMT -5
Epinephrine is hardly an orphan; it is the active ingredient in almost all asthma inhalers and has been administered in an inhaled form for decades. It is going to be very hard to show that a TS delivered dose of epinephrine is more effective than an inhaled micro-droplet dose so it will be back to the same reimbursement nightmare as with Afrezza vs insulin pens. The key is finding drugs that are delivered BETTER through the lung than via other routes but which do not presently have a lung delivery method. Every TS application will required a separate approval from the FDA's Office of Combination Products and requires the support and participation of both MNKD and the drug manufacturer. The hunt should begin by identifying those manufacturers that are looking for a competitive advantage rather than looking for a molecule that happens to work with TS. If the manufacturer is not fully engaged in the process they may decide to change their formulation for whatever reason and MNKD loses the combination product approval until all the testing is redone. You can do a lot of preliminary development work only to find out the manufacturer isn't willing to play ball, which is the death knell for any combination product. Money will be very tight; they need to avoid putting the cart before the horse. By orphan, I mean business opportunity. All of the drugs pale in market size as compared to insulin. The goal is up front money - I don't see a pony here. I think MNKD wants to use epinephrine in cases of allergy attacks (anaphylaxis). Here speed of drug delivery is important. It would compete with the Epipen.
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Post by mnkdmorelong on Jan 14, 2016 7:34:01 GMT -5
It would be awesome if somebody can find that story. If I understood correctly, that doc wrote an article about his experience. Or has anyone already found it? Yes he wrote an article but I have not seen it yet. Here we have an expert on diabetes management and could not figure out how to use Afrezza for his situation. The average patient would probably struggle more. This anecdote, as Matt said, explains in part why there were so many drop-outs under SNY. It also highlights how difficult it will be going forward. Perhaps the diabetes centers is the answer. If each had a Sam Finta on staff 24/7 (LOL), the drop out rate will be much smaller. To truly extract the benefit of Afrezza, the diabetic must be willing to let BG drop to near hypo levels. The secret sauce is that with RAA, the hypo goes on and could be dangerous. However with Afrezza, the insulin goes away and the hypo stops. Long term, near hypo conditions lead to lower HbA1c. CGM makes this easy. Without monitoring, it is an adventure.
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Post by mnkdmorelong on Jan 14, 2016 6:24:42 GMT -5
People keep taking about how marketing will cost 100s of millions. Before the internet existed a company had to hire 1000s of sales reps to individually inform and train the doctors and the company had no direct access to potential patients except for placing expensive advertisements in print media and advertising on TV. This took a huge workforce and a ton of money. Big Pharma still operates this way because they are used to it and everyone wants to preserve their jobs. Now that we have email, blogs, facebook, youtube, message boards, etc., why do we still have to do business this way? Can't Mannkind just team up with Amazon, let patients order on-line, and ship the stuff to doctor's offices? I realize it will be more difficult than this but I still don't see why Mannkind would need to get their own huge sales force. Five years from now when docs, patients and insurance are fully comfortable with Afrezza, an Amazon model will work. Matt recited a story last night of an endocrinologist who was invited to a SNY panel meeting. This endo is a diabetic who tried Afrezza and gave up. But once he heard how the drug should be used, he went back on and saw the benefits. The point of this anecdote is that using Afrezza is not natural when coming from RAA. The learning curve is steep and each patient must find his or her center. All this cannot be done on Amazon. Without a US salesforce, the growth of Afrezza in the US will be slow.
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Post by mnkdmorelong on Jan 14, 2016 5:27:21 GMT -5
There are three drug candidates for TS under consideration. Palonsetron (for Chemo), Epinephrine, and a third for pulmonary hypertension. All three put together are only a fraction of the insulin market. Except for Epinephrine, the drugs will have full clinical trials. Missing from the list is MNKD's pain med. Also missing are large volume drugs. I think this is why it has taken so long to get a TS deal. MNKD went through the list of high volume drugs and found no buyers. Now they are down to the orphan drug volume level.
I can't see any of the opportunities generating a large up front payment. MNKD needs cash now.
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Post by mnkdmorelong on Jan 13, 2016 21:21:18 GMT -5
One question that I'm interested in is how much inventory we already have. I think we have a huge amount of Afrezza warehoused, so selling in bulk overseas at lower margin for cash now when we need it might make very good financial sense. You know, this may have some merit. MNKD has a huge amount of lyophilized insulin that is not of the brand cleared by the FDA. This was the $10 bln of Afrezza statement Al made a few years back. The FDA is not in Korea nor Shenzhen China. If still active, this insulin could be formulated into a special overseas product.
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Post by mnkdmorelong on Jan 13, 2016 21:02:38 GMT -5
If true, that would be a huge point in MNKD's favor when pressing for settlement dollars. All things considered I thought Matt's comments could not have been more accepting of SNYs efforts. Unless there is a smoking gun out there, how does MNKD make the case that they were 'had'? Matt was a statesman tonight with respect to the SNY relationship. But I could see his blond hair turning red as he spoke. When he negotiates with SNY for a severance agreement, he will not be so tactful. It's like this: You marry a woman and have a kid. You want another kid; she only wants one. Was the guy "had?"
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Post by mnkdmorelong on Jan 13, 2016 20:51:35 GMT -5
I agree, as optimistic as the new roadmap is, there is significant risk and cannot be done with zero sales force. So, some expense for a sales force (and reimbursement specialists to negotiate with payers), etc. must be expected and where those dollars come from is not yet known. Matt gave little detail here. There was a discussion about Deerfield that was cut off quite quickly - perhaps MNKD would intend to sell some revenue rights to Deerfield (or similar) for near term cash to pursue this strategy. I'm probably making that up from nothing and I don't know if I like it, but I got a brief sniff of that in between what was said. Deal with the devil if you ask me; I'd sooner have dilution at the first reasonable opportunity. Hopefully, there is some parting SNY money (Al loan extension was not brought up) or enough to come in an international rights deal to forestall going down the Deerfield road any farther. Quick overseas expansion does not address the need for revenues to cover the $90M core burn rate. But it could certainly cover fixed Afrezza costs and prevent the more serious issue of having to bring on new Afrezza expenditures impacting cash flows. The whole SNY pricing thing will remain a mystery I am afraid. I find it hard to believe they would sign a contract knowing where this would land. SNY would have had to do a lot of convincing that this was the right strategy. Consider MNKD as a pre IPO company. If they can prove an increase in value, more funding comes their way. I caught the same Deerfield hint as you did. Maybe a few dollars from SNY; at least forgive the loan balance. Maybe not surprising is that Al Mann did not mount the stage with a money bazooka. He may be tapped out. From my perspective, MNKD needs $200-250 mln cash. They need to put on some FTEs in the US to service sales. A two year runway is needed. Even then they may not be cash flow neutral.
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