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Post by compound26 on Feb 11, 2016 15:37:57 GMT -5
Dr. Aaron Kowalski was one of the 17 public speakers spoke at the 2014 AdCom supporting FDA's approval of Afrezza. diatribe.org/issues/63/new-now-next/1The diaTribe team was onsite during the meeting, as Editor-in-Chief Kelly Close and Managing Editor Adam Brown spoke as patients during the Open Public Hearing (OPH). Both advocated in favor of patients being given a wider range of treatment options, including Afrezza. See Adam’s slides here, and Kelly’s talk and slides here and here. An impressive 17 speakers came to the OPH to speak on behalf of Afrezza (the largest ever for a diabetes-related therapy), and all noted the importance of increasing treatment options for patients and improving the patient experience. We found it to be an incredibly powerful session, one that included leaders Dr. Aaron Kowalski from JDRF, Dr. Robert Ratner from ADA, Dr. Steve Edelman of TCOYD, Bennet Dunlap of Strip Safely, and the legendary Dr. Lois Jovanovič of Sansum Diabetes, a renowned researcher whose trip was paid for by patients who wanted to cover the costs of her testimony. Manny Hernandez of the Diabetes Hands Foundation was also able to testify via webcast – a first for the FDA and an impressive diabetes advocacy achievement. You can view a recording of his testimony here and read more great quotes we heard at the OPH in our quotable quotes this issue. www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM397049.pdfThere is an informative interview of Dr. Aaron Kowalski published by diaTribe. diatribe.org/diatribe-exclusive-interview-dr-aaron-kowalski-jdrf-first-ever-chief-mission-officerPer the interview, "as Chief Mission Officer, Aaron plans that his top priority will be working closely with JDRF’s team to ensure that new treatments get into the hands of people with diabetes more quickly. Additionally, Aaron’s new role will allow him to work as a bridge between the community of people impacted by type 1 diabetes and all that JDRF is doing on the research and advocacy fronts. No one is better positioned to do so, given his deep scientific knowledge of type 1 diabetes, his valuable, decade-long experience at JDRF, his patient perspective from nearly 30 years of type 1 diabetes and a close family member (his brother) for nearly 40 years, and a never-ending drive to make life better for people with diabetes. JDRF’s mission is to “turn type one into type none,” and with this new promotion, we are confident that Dr. Kowalski is the very best choice to make that mission a reality." |
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Post by compound26 on Feb 9, 2016 16:28:37 GMT -5
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Post by compound26 on Feb 9, 2016 13:26:54 GMT -5
It appears to me Sanofi probably stopped any real efforts on promoting Afrezza at the beginning of June 2015, when the 2015 ADA meeting was in session. Or alternatively, a decision was reached by Sanofi at that time that Afrezza would be dropped from Sanofi's portfolio as soon as possible (i.e., at the beginning of 2016). If one looks at the Symphony reports on NRx and TRx, he/she will notice that the NRx reached 311 on June 5, 2015 and has been hovering around 300 since then. This indicates that no real efforts were made by Sanofi to expand the prescribing base after June 2015. mnkd.proboards.com/attachment/download/1788Amy Tenderich's recap on the 2015 ADA meeting confirms that Sanofi wasn't putting any real efforts into promoting Afrezza from the beginning. www.healthline.com/diabetesmine/overview-ada-scientific-sessions-2015#8"Although this big sign greeted attendees at the main entrance to the Exhibit hall, there wasn’t as much buzz about Sanofi’s Afrezza as you might expect, given that is one of the most exciting new treatment options recently FDA-approved and launched (it’s the first commercially viable non-invasive insulin, for God’s sake!)Frankly, I was expecting Afrezza to be the drug plastered all over the convention shuttle buses this year, but nope, that seemed to be mostly Invokana again, like last year. Afrezza was covered in a “Product Theater” on Saturday morning. This was a very, dry medical introduction of the drug, that due to regulations had to start with the long laundry list of possible risks and drawbacks. Although the session was a pretty packed house of about 180 doctors I’d guess, it certainly wasn't inspiring by any stretch of the imagination. And it appears the only other presentation on Afrezza at this entire conference was a corporate-sponsored CME (continuing medical education) symposium held on Sunday evening. I would’ve loved to have been a fly on the wall at that one. The "low profile" of Afrezza was corroborated by prominent endocrinologist Dr. Irl Hirsch when I bumped into him in the ADA speaker room. We shrugged our shoulders at each other over how Afrezza doesn’t seem to be getting a fair shake (see the LA Times article on same topic, and one analyst who remarks that the distraction of the ADA conference itself may be one reason that Afrezza prescriptions are coming in so slowly – how ironic!) Observers are holding their breaths to see how the upcoming consumer ad campaign affects Afrezza sales, it seems. When I met with Sanofi execs, I was able to ask them directly, and was told there’ve been three barriers to Afrezza’s success so far: 1. Physicians haven’t heard about inhalable insulin for several years (and lingering memories of the Exubera fiasco don’t help) 2. The requirement for a pulmonary function test is a deterrent – doctors have to figure out where to refer patients for this, or decided to fork over the roughly $600 to get their own machine 3. Reimbursement is a struggle, as Medicare and the other Payors already have one or more preferred rapid-acting insulin products on their formularies, so Afrezza is getting bumped to a lower tier (meaning not covered so much) Sanofi does plan to begin a consumer advertising campaign towards the end of this year that will focus on digital and print, but no TV ads, according to Andrew Purcell, Head of the Diabetes Business Unit at Sanofi. They’re hoping to “demonstrate success” with the drug first, and also by then, the newly approved 12-unit cartridge will be available too (although personally I’d be more excited about a 2-unit option). Meanwhile, Sanofi was making a big splash about their new long-acting insulin Toujeo, with a smoother profile and even less incidence of hypoglycemia than their market-leader Lantus. They were presenting a lot of positive data on Toujeo, which comes in a Solostar pen similar to that for Lantus, but tweaked especially for this product to carry 450 units. And the big deal is that they’re rolling out a new coaching program (Toujeo COACH), in which patients get one-on-one training and optional followup calls and emails from a nurse or CDE. Nice! Who doesn’t love a little hand-holding with a new diabetes tool? We heard the company just announced extending this COACH program to Afrezza too -- much-need, and cool! Meanwhile, they assure us they are not abandoning Lantus, for doctors and patients who remain loyal to that drug."
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Post by compound26 on Feb 8, 2016 17:04:29 GMT -5
Note that in the third quarter conference call, Hakan also noted that he certainly would like to see some TV ads. Below is what Hakan said: seekingalpha.com/article/3669586-mannkinds-mnkd-ceo-hakan-edstrom-q3-2015-results-earnings-call-transcript?part=singleKeith Markey"Okay, thank you. And then I have sort of a -- I think that you are facing somewhat of a chicken and an egg question here. On the one hand, Sanofi probably doesn't want to spend whole lot of money on direct-to-consumer advertising, especially television for instance, if they don't have reimbursement in place. But on the other hand, I am just wondering do you think that direct -- if they did some direct-to-consumer advertising that really generating the great deal of interest that patients walking into the doctor's office and talking to their insurance companies would have any beneficial effect on trying to move those negotiations forward?" Hakan Edstrom"Well, I know that there are certainly plans from Sanofi point of view in ruling at that direction. The timing tends to usually be based on what level of awareness do you have in the professional communities, so you are not, say, surprising doctors with, say, patient demand or patient questions that they may not be prepared for. Whether it would impact the negotiations with insurance companies, I don't really know how compelled they are, but that type of the information, it would certainly demonstrate to them that, but there is a perceived need of the product out in the market place. So I think from our point of view, it certainly would not hurt. The question is what is an appropriate timing and approach to have that as a, say, a support mechanism." But in the end, we know that Sanofi never run any TV ads for Afrezza. So apparently, in 2015, Mannkind wasn't in total agreement with Sanofi in either pricing or marketing (TV ads is an example). However, being the junior partner, they basically have to acquiescence to whatever Sanofi decided in the JAC. |
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Post by compound26 on Feb 8, 2016 12:09:43 GMT -5
Here is what Matt said in his 3 Feb presentation:
Now regarding international expansion, PRIOR TO SIGNING THE AGREEMENT WITH SANOFI, MANNKIND WAS IN DISCUSSIONS WITH MULTIPLE INTERNATIONAL GROUPS REPRESENTING SUBSTANTIAL REGIONAL MARKETS. THOSE DISCUSSIONS HAVE NOW BEEN RESTARTED in RECENT WEEKS with our priority being THOSE REGIONS in which we can use our U.S. approval as a basis for regulatory submission without additional trials. As these plans firm up, we’ll be sharing them with you.
And we did say an important part of our strategy is to go back into some of those foreign markets specifically where there’s no new clinical trials required and try to capture some volume quickly there, because we know the product is very volume-sensitive from a cost to goods standpoint. And in order to make it more profitable everywhere, especially in the U.S., we need to get the volume up relatively quickly and that’s a good way to get your margins up quickly too. So, it’s kind of a win-win for us. It doesn’t mean we wouldn’t consider some jurisdictions that have clinical trials required, in fact I know for a fact WE’RE TALKING TO AT LEAST ONE WHERE IT PROBABLY WILL BE. But our focus is really on trying to get things where we can GET A DEAL DONE QUICKLY AND START SELLING THE PRODUCT IN A FOREIGN JURISDICTION. SO YOU WOULD EXPECT TO SEE SOME STUFF FROM US I HOPE FAIRLY QUICKLY but I would be reluctant to commit to a specific timeline because I’m sure Ray will kick me under the table if I do.
Here is my interpretation of Matt's statement:
1. There are certainly partners there that are interested in partnering with Mannkind at this moment (despite Sanofi's election to terminate its partnership);
2. While the Sanofi's partnership agreement restricts Mannking from doing a lot of things (talking to insurance or submit new appilcations) during the current transition period, it does not appear to restrict Mannkind's ability to talk to other partners right now. Sanofi's is license is non-exclusive during the transition period.
3. Mannkind probably is in discussions with several regional partners about partnership right now;
4. One of the partners in discussion is for either EU or Japan, as that jurisdiction requires additional trials;
5. Mannkind probably will be able to announce an international partnership for Afrezza by 5 April (as Matt said Mannkind will hold a conference call when the transition of Afrezza back to Mannkind is effective);
6. If remains to be seen whether Mannkind will get any upfront fee from such partnerships. But I would expect Mannkind to offer to lower its share of profits for exchange of some upfront fee; and
7. If indeed one of the partners in discussion is for either EU or Japan, I would expect such partnership to include some type of upfront fee as both EU and Japan are substantial markets.
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Post by compound26 on Feb 2, 2016 18:18:30 GMT -5
Agree that Sanofi probably wasn't intentionally trying to bury Afrezza. However, Sanofi's efforts on Afrezza (granted a traditional approach) probably did not meet the "commercially reasonable efforts" standard set forth in the partnership agreement. This is pretty apparent when one compares the efforts Sanofi spent on Afrezza vs its efforts on Toujeo, both were launched by Sanofi around the same time. Big question is whether they put the same effort into getting formulary placement for Afrezza. Toujeo fared much better for whatever reason. With the poor formulary coverage it is easy for SNY to claim the rest of their efforts were in line with that reality. Who knows... MNKD might have even approved all the strategy in JAC, such as not running TV ads. Proving that SNY did not do as much for Afrezza formulary would be hard to prove as those negotiations with PBM are likely covered by non-disclosure agreements. If Sanofi priced Afrezza with a significant premium to RAA without a superiority trial and label improvement in the plan, that does not sound like a plan for success from the starting point. Looking with hindsight, had Sanofi even considered a superiority trial during the existence of the partnership? Does the December San Diego meeting give hint of a superiority trial? Then why the sudden termination of the partnership? |
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Post by compound26 on Feb 2, 2016 18:06:19 GMT -5
I agree with Matt. SNY tried a traditional approach and failed. They didn't sandbag it, meaning intentionally trying to bury it. I think the new CEO concluded it was more work than they were anticipating, a long haul and they needed to redirect their efforts to existing drugs that were 100% in their portfolio. Agree that Sanofi probably wasn't intentionally trying to bury Afrezza. However, Sanofi's efforts on Afrezza (granted a traditional approach) probably did not meet the "commercially reasonable efforts" standard set forth in the partnership agreement. This is pretty apparent when one compares the efforts Sanofi spent on Afrezza vs its efforts on Toujeo, both were launched by Sanofi around the same time. Had Sanofi made the "commercially reasonable efforts", the TRx should be (at least) a couple of times higher than the current level. |
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Post by compound26 on Feb 2, 2016 15:55:42 GMT -5
Did Sanofi satisfy its obligation of using Commercially Reasonable Efforts to market, promote and Commercialize Afrezza?
Under Section 5.1(c) of the partnership agreement:
Sanofi shall use Commercially Reasonable Efforts to market, promote and Commercialize Product in the Field in countries in the Territory where regulatory approval has been received, it being understood that the application of Commercially Reasonable Efforts may result in Sanofi deciding not to market, promote or Commercialize Product in any particular country or countries.
Under Section 1.25 of the partnership agreement:
“Commercially Reasonable Efforts” shall mean:
(a) With respect to efforts of Sanofi as measured on a country by country basis: that measure of efforts and resources consistent with Sanofi’s and its Affiliates’ own efforts and resources applied to its and their own compounds, devices and products of a similar value, stage of development, life cycle and commercial potential, taking into account all relevant factors including issues of safety and efficacy, product profile, difficulty in developing or manufacturing the applicable Product or sourcing raw materials necessary therefor, competitiveness of alternative third party products in the marketplace, regulatory approvals (including pricing approvals), pricing and reimbursement, the patent or other proprietary position of the applicable Product, the regulatory requirements involved and the potential profitability of the applicable Product for Sanofi and its Affiliates as compared to the expected profitability of other products of its then current or in development product portfolios; and
(b) With respect to efforts of the Licensors: the use of reasonable efforts and resources, in good faith, consistent with the efforts and resources that a pharmaceutical or biotechnology company of similar size and situation to the Licensors, in the exercise of prudent legal, medical, scientific and business judgment, would commonly apply to its own compounds, devices and products of a similar value, stage of development, life cycle and commercial potential to the applicable Product.
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Post by compound26 on Jan 28, 2016 11:09:57 GMT -5
I think it was a win-win situation. Mannkind has to provide senior scientific support, per the agreement with RLS. RLS has the cash to pay her well and her salary gets removed from Mannkind's payroll. Agree. I think it is a good thing that RLS takes over the payroll of a few engineers from Mannkind at this moment. This helps Mannkind to extend its runway for marketing Afrezza with the available cash without Mannkind having to lay off these people (layoffs by Mannkind will always be spun as FUD). |
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Post by compound26 on Jan 27, 2016 16:54:58 GMT -5
With the prices of 2017 and 2018 calls this cheap right now, the shorts may have either hedged themselves or will have an easy time to cover via purchase of calls if they need to (until our PPS goes back to say $3 or higher). At this point of time, I think we probably do not need to worry ourselves on shorts any more, whether they have covered or not. I do not think a short squeeze will ever occur, even if we eventually recover to $5/6, or for that matter $10, or higher. A short squeeze will only occur if a buy-out with significant premium is announced to the surprise of the shorts (so that they do not have time to cover). If a buy-out at a price of $5/6 or higher is announced today, there may be a short squeeze.  |
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Post by compound26 on Jan 27, 2016 16:16:13 GMT -5
Biotech companies' PPS do sometimes trade at levels far from its true value. Merck To Buy Idenix Pharmaceuticals For $3.85B, Expanding Foothold In Hep C Drug Market BY SNEHA SHANKAR @snehashankar30 ON 06/10/14 AT 5:09 AM www.ibtimes.com/merck-buy-idenix-pharmaceuticals-385b-expanding-foothold-hep-c-drug-market-1596744Merck & Co. (NYSE:MRK) announced Monday that it will acquire Idenix Pharmaceuticals (NASDAQ:IDIX) for $3.85 billion, to establish a stronger foothold in the market for hepatitis C drugs. New Jersey-based vaccine maker Merck said that it will pay $24.50 a share in cash, which is 3.4 times the value of Idenix stock, which closed at $7.23 on Friday. I also recall at some point prior to the buy out, IDIX was trading at less than $5. I agree. Buyouts at multiples of 2 or 3 times current market cap are not unusual. Even higher multiples are possible. But even $3 or $4/share is too low at this early stage in MNKD's attempt to turn things around. We are only a little more than 3 weeks into the 6 months MNKD has to put a plan into action. I doubt either Al or the Boards of Directors is in a mood to give the company away at this point. Neither am I. Agree. I would think Mannkind (and Al Mann) will have to look at every offer. However, Al Mann probably will not seriously consider offers under $5 (a share). |
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Post by compound26 on Jan 27, 2016 15:53:09 GMT -5
Mental math is fine, but very few deals go off at valuations higher than a 50% premium to current market. Most healthcare deals are done with a premium between 20-35%. As I write this the price has moved back down to about $1, so we are talking $1.50. There are three limiting factors: 1. Shareholders from the buyer would show up at their company's headquarters with pitchforks and burning torches. The board of directors would be close behind with buckets of hot tar and feathers. If you do the math on $55 price, including debt, including debt conversion options, and warrants, MNKD would have a $30 billion price tag. There are many pharma companies with $30B price tags that are profitable, well capitalized, and with sales. Is MNKD really as valuable as Baxalta, Biomarin, Shire, and Vertex? Heck, Teva is only worth a bit more. 2. Pharma companies do not pay real cash for Chinese math, and what you proposed is what is known in the finance world as Chinese math (i.e. speculation). If it was so easy to hit penetration numbers, even Sanofi would have done it. The risks of failure in the real world are a lot more daunting, which is why nobody pays up for potential in a mature market. Everybody learned a lesson from the "Dot Com" bubble, and pharmas had their own acquisition bubble in the late 1980's and early 1990's. 3. Even if the executives could initially escape from the angry mob, they have to earn a return on that $30B investment to keep their jobs. Return on equity in drugs averages 20% after tax so MNKD would need to return $6 billion in after-tax profits a year, this year, next year, and every other year in perpetuity just to keep pace. Only if MNKD earned more than $6B per year would the shareholders of the buyer be better off and, if they are not, refer to point 1 above. Biotech companies' PPS do sometimes trade at levels far from its true value. Merck To Buy Idenix Pharmaceuticals For $3.85B, Expanding Foothold In Hep C Drug Market BY SNEHA SHANKAR @snehashankar30 ON 06/10/14 AT 5:09 AM www.ibtimes.com/merck-buy-idenix-pharmaceuticals-385b-expanding-foothold-hep-c-drug-market-1596744Merck & Co. (NYSE:MRK) announced Monday that it will acquire Idenix Pharmaceuticals (NASDAQ:IDIX) for $3.85 billion, to establish a stronger foothold in the market for hepatitis C drugs. New Jersey-based vaccine maker Merck said that it will pay $24.50 a share in cash, which is 3.4 times the value of Idenix stock, which closed at $7.23 on Friday. I also recall at some point prior to the buy-out, IDIX was trading at less than $5. |
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Post by compound26 on Jan 27, 2016 13:26:49 GMT -5
I believe Al personally invested about $1 billion into Mannkind (and 10+ years of his life and hard word). He would expect to at least recover his investment. Since Al now owes 40% of Mannkind, I would expect Al to be willing to consider offers of $2.5 billion (and above) for the whole company (around $5/6 per share, considering the current shares outstanding and the existing loans). Admittedly, Mannkind is not in a great position financially, but there are certainly options for Al and Mannkind to get the funds to sustain the operation till the end of 2017. Therefore, if there are no reasonably acceptable offers as described above, I would think Mannkind still could opt to pursue the marketing strategy Matt outlined in the JPM presentation. The value and potential of Afrezza is clearly there. The current PPS of Mannkind is severely depressed by short selling and manipulation. Without these forces, the PPS may well have been around $3-6 right now and that would have enabled Mannkind to pretty easily raise enough money to support Afrezza marketing via a second offering. I think all the potential acquirers (along with Al and Mannkind management) understand this. So a buy-out at $5-6 or higher actually is not that far-fetched. |
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Post by compound26 on Jan 26, 2016 15:47:03 GMT -5
Just spitballin' here but is everyone ok with a 1 for 1 in Berkshire A shares? (Apologies to Warren as i feel i must) I am fine with B shares. |
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Post by compound26 on Jan 26, 2016 15:38:25 GMT -5
I believe Al personally invested about $1 billion into Mannkind (and 10+ years of his life and hard word). He would expect to at least recover his investment. Since Al now owes 40% of Mannkind, I would expect Al to be willing to consider offers of $2.5 billion (and above) for the whole company (around $5/6 per share, considering the current shares outstanding and the existing loans).
Admittedly, Mannkind is not in a great position financially, but there are certainly options for Al and Mannkind to get the funds to sustain the operation till the end of 2017. Therefore, if there are no reasonably acceptable offers as described above, I would think Mannkind still could opt to pursue the marketing strategy Matt outlined in the JPM presentation.
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