Sny IR Slide:
New data from the AFFINITY 1 study
● No increase in hypoglycemia risk resulting from a
Supplemental dose of Afrezza 90 mins post meal
According to Late Breaking AACE abstract
Substantial execution of peer-to-peer education"
I think this may refer to the Sanofi-sponsored dinner presentations. I can't believe that there is even one tonight in a small neighborhood in my hometown. If they are doing this there, it seems they may be doing this everywhere.
Afrezza®: Targeted U.S. Launch
to Build Awareness and Ensure Appropriate Usage
● U.S. launch of Afrezza® in Feb 2015 ● New option to initiate or intensify insulin ● Distinct PK/PD profile
● Ongoing efforts to improve market access
● Additional promotion in H2 2015
● DTC promotion
● Afrezza® COACH Patient support program ● Peer-to-peereducation
● 12-unit cartridge introduction
Distinct PK Profile(2)
He mentioned that a supplemental dose of Afrezza 90 minutes after a meal did not cause a hypo.
A lot of the early users are finding out that a supplemental dose after the meal is very helpful, as Afrezza leaves the system so fast.
* They are securing Tier 3 No authorization first, which they have made significant progress by having contracts done with many payors.
* Few thousand doctor details made during the ADA, split evenly between Toujeo and Afrezza
* DTC starting "in a few weeks"
* Launching 12U cartridge soon. I believe he misspoke when he gave the timing and meant to say "late 2Q, early 3Q", but it came out "late 2Q, late 3Q".
* Publishing Peer reviewed data from the AFFINITY 1/AFFINITY 2 studies
* 25% increase in foot traffic at this years ADA vs. last
* Explained their initial strategy of rolling out to high volume locations and select practices first in these recent months.
The shorting was done quite some time ago, perhaps even last July when PPS was in the 10s and 11s. Wall Street shorted a large balance of shares that must eventually be covered. Now, they're driving the PPS back up, maybe into the 7s or 8s. Then cover another 15 million shares or so via the conversion at the conversion price of 6.80. ($100 million @ 6.80 per share yields about 14.7 million shares converted). Make money in both directions on the convertible debt.
Presto. Maybe 25, 30 or 40 million shares covered by next August.
In preparation for the predicted sales growth, MannKind is increasing manufacturing capacity at its production facilities in Danbury, Connecticut, and Denver, Colorado.
“We started out with just one line in operation and we now have three lines in operation,” he said, adding the firm had begun production of a 12-unit cartridge strength of Afrezza following FDA approval back in April ready for Sanofi to launch in the next quarter.
The sites have been expanded since Afrezza was in Phase III studies and the company has previously said further capacity can be added in a “relatively rapid modular way” to cope with an expected volume of two billion cartridges a year.
Despite these expansions, MannKind is looking to reduce its operational costs by centralising production to these sites and Pfeffer announced it is looking to sell “a huge monstrous facility [in California] that’s largely empty these days,” as MannKind no longer needs certain production functions now Sanofi is on board.
The sale is the second abandonment of manufacturing space: “We formerly had a facility in New Jersey that we've now closed,” Pfeffer said, and while some of the staff was transferred to Connecticut, other roles are now obsolete due to the Sanofi deal.
MannKind: Social media buzz will propel Afrezza to blockbuster status
MannKind’s CFO has no doubt Afrezza will be a blockbuster despite a slow start since launch and is adjusting its manufacturing network in preparation.
The inhalable insulin product Afrezza launched in the US in February, and while initial sales have been subdued, Matt Pfeffer, CFO of the developer and manufacturer of the product, MannKind Corporation, said he has no doubt the drug will hit sales targets.
Pfeffer has previously told this publication the slow uptake is down to marketing delays, but speaking at the Jefferies 2015 Global Healthcare Conference yesterday he explained Afrezza’s commercialisation partner Sanofi led a “focused and targeted launch initially with the idea that it would be extended outward over time.”
Initially, Sanofi focused on convincing endocrinologists to back Afrezza on the basis that their adoption of the product would influence general practitioners. Now the strategy is to create a buzz by reaching out to diabetics, as Pfeffer explained.
“It’s a very active community, people are very vocal and it's not very hard to go and find out what people think of this product,” he said. “These people are out there tweeting about their experiences and literally posting pictures of their blood glucose monitors and other things which is very, very encouraging. I’ve yet to find anybody say anything other than they loved the product, so [while] the initial launch is a little slow it gives me hope, I think it’s going to get there.
"If they love it as much as everybody says they are - and I’ve yet to find an exception - I have no doubt it’s going to be the blockbuster product we all thought it would be."
And a quick look on line confirms this, with Twitter awash with such tweets from users and potential users of the product:
The #afrezza buzz is like this. 22 years I NEVER could "dial in" humalog. Tried hard. 103 days with afrezza "dialed in" = lowest a1c ever
11:33am - 3 Jun 15
Events and Presentations Shake Out MannKind Short Sellers
153576724MannKind Corp. (NASDAQ: MNKD) remains one of the most controversial stocks in the realm of biotech and pharmaceuticals. After finally getting U.S. Food and Drug Administration (FDA) clearance for the inhalable insulin Afrezza, and after a very slow start to the diabetes market, MannKind shares have now nearly doubled from their 52-week low.
A few things are driving the cart here. One is the 2015 Annual American Diabetes Association, which gives more awareness opportunity for Afrezza to be discussed by physicians and patients. A presentation at the Jefferies conference last week was a boost, and there is hope that its presentation at the Goldman Sachs 36th Annual Global Healthcare Conference on Wednesday, June 10, 2015 will be another driver here. Lastly, short covering is an obvious force here.
24/7 Wall St. has tracked many issues around MannKind over the years. This stock looked as though it was grossly oversold and was becoming overly bearish in sentiment in prior weeks, but then it looked as though shares had signaled a bottom. It was just on May 12, 2015, when MannKind shares hit a 52-week low of $3.46. With an 8% gain to $6.65 on Monday, its shares are approaching a 100% gain in just under a month.
While MannKind recently signaled that more products might be coming, and while the firm Jefferies recently gave it a stellar upside target of $9.00, much of this had already been known.
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The coming Goldman Sachs health care conference this Wednesday could be another driving force. At issue is that Goldman Sachs has been very negative on MannKind. In fact, the firm’s Sell rating and prior $3 target have come with bullish investor allegations in chat rooms and social media that the analyst has a vested bias against MannKind over issues that we will not go in detail about here.
It seems as though investors are taking the firm’s appearance at the Goldman Sachs conference as meaning MannKind can overcome the Goldman Sachs research tone. If a company knows going into a presentation that it has no chance of getting a positive reception, why bother to schedule a showing, and then bother even further by showing up?
Another key driving force behind the sharp snapback rally in MannKind is the huge short covering. The last short interest settlement date of May 15 showed a whopping 112.9 million shares in the short interest. This was the ninth increase in the short interest and was a new high for at least the past year — and it was more than one-fourth of the shares outstanding.
It is not common at all for a quarter of a company’s shares outstanding to be sold short. This means that any hint of positive news will send short sellers running for cover. That creates buying to exit the shares, and it allows nimble speculative buyers to jump into the situation betting that the pain will cause short sellers to buy even more.
It is worth noting that the peak in the short interest also was within days of the 52-week and multiyear low. Below is a listing of the raw short interest based on settlement dates:
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While it will be interesting to see what happened to the short interest for the May 29 settlement date period, it will still have a rather large look-back to the data — at $6.65 on Monday, MannKind shares were down at $5.18 on that settlement date, and the stock was down around $4.50 to $5.20 in the four trading days prior to that.
A change in sentiment often occurs faster than normal when short sellers are forced to exit a big bet. Now it is up to MannKind to see if the recovery can continue.
SEC Probes Activist Funds Over Whether They Secretly Acted in Concert
Federal securities rules require shareholder activists to disclose joint campaigns
June 4, 2015 4:53 p.m. ET
The Securities and Exchange Commission is investigating whether some activist investors teamed up to target companies without disclosing their alliances, potentially in violation of federal securities rules, according to people familiar with the matter.
The SEC’s enforcement division has recently opened multiple investigations and sent requests for information to a number of hedge funds, according to some of the people. Neither the names of the funds nor the companies they targeted could immediately be ascertained.
SEC representatives didn’t immediately respond to requests for comment.
As part of a broader effort to promote transparency, the SEC is looking at whether certain investors coordinated their efforts without filing appropriate disclosures. Federal securities regulations require investors who jointly agree to buy, sell or vote securities to disclose those arrangements, and to designate themselves as a group if they together own at least 5% of a company’s stock
The SEC is investigating whether activist investors skirted rules on disclosure of investments made with other funds. Some of the main hedge-fund disclosure rules:
5% Threshold: Activists have to disclose once they cross 5% ownership of a company within ten days
Work in Concert: Activists must disclose any agreements to work with other funds on an investment. If no single fund owns 5% but the group owns that much collectively, that must be disclosed.
Groups: Generally a group is considered to exist if the investors have reached any sort of agreement on how they will vote their shares or when they will trade the stock.
Write to Liz Hoffman at liz.hoffman@wsjDOcom and David Benoit at david.benoit@w
Approaching 34M Volume. Longs don't quick flip this time as Schwab, Fidel offer 30%, 29.25% income interest. Longs can hardly find a better Dividend stock than this in the entire Nasdaq and foreign exchanges. Schwab raised income rate to 30%. Fidel 29.25%. No Short Covering.
Triple Crown 13Gs Filing in 10 days will test $11.48 resistance. No major resistance until then.
BR already owns 4.7%, 19,137,425 shares on 5/8/15. They only needs to accumulate 1.27M more shares to file 13G. So, this is already in the bag, filed by June End.
Vanguard Group, Inc owns 15,960,530 as of 3/31/15. Van needs to accumulate 4.49M more shares to meet 5%. Thus, this is likely in the bag. Furthermore,
Vanguard Small-Cap Index Fund owns 4,257,307
Vanguard Total Stock Market Index Fund owns 4,091,602
Vanguard Small-Cap Growth Index Fund owns 2,795,698
Vanguard Extended Market Index Fund owns 2,425,035
FMR, LLC owns 9,214,968
Fidelity Select Portfolios - Biotechnology owns 8,063,306
Together the owns 17.2M. They need to accumulate 3.25M more shares to meet 5%. Thus, this is likely in the bag.
Sanofi's Afrezza Sales Leader Schwarts "This is Just Too Important". They most likely accumulating 20.45M shares from $3.6 all the way up. After 5%, Sny would be out of closet to negotiate w/ Mnkd for more Buy-In.
Expect $16-$24/sh for Afrezza using 130M approved by 2015 ASM, 200M SNY shares left over from 2014 ASM. respectively. Mnkd needs this to full-fledgedly fund Mnkd Tech Corp Pipeline R&D.
Approaching 21M volume. Fidel, Vanguard are accumulating too. We may see Triple Crown 13Gs filing by Sny, BR, Fidel, or Vanguard aka KY Derby, Preakness, Belmont Stakes.