Short interest discussion thread

[mnholdem]

I'm not aware the six-month delay on Direct-to-Consumer Advertising ever became a "law"

This is an old article (2008), but raises the point that a six-month delay in DTCA is "left to the discretion of the individual company".

--------

pharmamkting.blogspot.com/2008/07/can-moratorium-delayed-dtc-ad-refer-to.html

Can a Moratorium-delayed DTC Ad Refer to a Drug as "New"?

Last month, WSJ Health Blog reported that "Drugmakers [Merck, Pfzier, J&J, to name a few] called before Congress to explain their direct-to-consumer [DTC] ads have agreed to wait six months before advertising newly approved drugs to the general public."

But I wonder if marketers in these companies have has asked themselves this question:

Given DDMAC’s policy that a new drug can only be new for six months after marketing launch, does that mean that brands who observe a 6-month or longer DTCA moratorium cannot claim "new" in their consumer ads?

That was a question recently posed by a client to my long-time colleague and Pharma Marketing Roundtable member, Mario Cavallini, Manager of Competitive Intelligence at Rosetta Marketing, who answered: "Interesting question; I don’t know whether anybody’s put those two together before."

The FDA guideline that a prescription med can only be "new" for six months comes (I believe, but could be mistaken on this) not from firm legislation but from "case law" pattern of rulings by DDMAC [Division of Drug Marketing, Advertising and Communications; the FDA division responsible for overseeing drug promotions].

In any event, the “six months for ‘new’ status” rule predates the PhRMA DTC Guiding Principles, which introduced the moratorium. Strictly speaking, the Guiding Principles only call for “an appropriate amount of time to educate health professionals about a new medicine or new therapeutic indication before commencing the first DTC advertising campaign” (by which, the Guiding Principles specifically means broadcast media and print advertising, but not Web sites and online media). How long and how broad the moratorium should be is left to the discretion of the individual company and brand. Six months is typical, but some have a one-year policy, some shorter.

PhRMA offers no guidance on whether the “new” clock starts at FDA approval, brand launch, or campaign launch. However, according to the FAQ page at DDMAC, the clock starts at campaign launch:

DDMAC generally considers that "New" is an accurate description of the marketing phase for six months from the time a product is initially marketed. This should be distinguished from the time the product is cleared by FDA for marketing.

So, on the one hand, it seems clear that the 6-month “new” clock starts at the end of the moratorium. But remember that the PhRMA guidelines only cover so-called mass media. DDMAC does not make such a distinction; if a brand puts up a brand Web site and runs banners within days of FDA approval, and then six months later starts running TV ads with “new” in the creative, I really can’t say whether that will be a problem or not.

Given that the point to the PhRMA moratorium is to allow marketing to HCPs before the messaging to consumers kicks in, my GUESS is that DDMAC would start the "marketing clock" at product launch, not campaign launch. That is, as soon as HCP marketing begins, that product is marketed and the 6-month clock starts.Will this compel companies that observe a 6-month moratorium to NOT launch a Web site for the drug until the end of the moratorium? I don't think so because the FDA and the industry have always considered brand web sites as labeling, not DTC advertising.

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Incidentally, according to Wikipedia, Direct-to-Consumer Advertising of prescription drugs is permitted in only two countries: New Zealand and the United States.

[kc]

Scotta, Your point on DTC is a good one. But my view is that Sanofi can't even do their work well to start advertising until they have 3 lines up and that all Endo's and GP's have been seen and educated. This also is true of the diabetic instructors who teach diabetics how to control with insulin. We are in a launch with the early adaptors leading the way with their viral blogs and postings. So from my 10,000 ft. view things don't rely for awhile on script count. 6 to 10 months from now they are important.

[Deleted]

x

[petech]

I have a question, how often is short interest updated on the bloomberg terminals?  I have a friend who can access it; but the 90.7M short shares / 17 days to cover are probably static from the last time reported.  Thoughts?

I really don't know how shorts plan to cover that many shares.  I thought the idea was to use bear raids to cover...but that doesn't seem to be happening.  Don't get me wrong, I'm happy to get credit-card-default-rate interest on my shares...but I don't know how they dig themselves out of this hole.  Sure, no drug starts out with $5B in sales...so early sales reports in the quarterly calls can be used to fear-monger....but IMO you have to be absolutely convinced this fails to have a short count this high.  

At least the 9M of shares from BOA should come back soon.  Unless we extend that financing and let them keep the shares longer.  But we're in a much better risk position now...so I am assuming the refinancing of that debt will be on better terms.

I just don't get it.  91M shares short, volume/share price movement is laughable today so the Zacks/Street press didn't do anything, and all anecdotal evidence is that Afrezza is a game changer by both doctors and end users....so it is only a matter of time before sales multiply....don't the shorts want to start covering soon?  I just don't get it.

Final question, is there an easy way to track how many shares are available to short and at what % in the various brokers?  It would be interesting to keep track of that.  Fidelity is "call us" at 28.5%...that's all I got.  This is down from "call us" and 31.5% recently.  

[BlueCat]

Mar 18, 2015 7:08:33 GMT -5 mnholdem said:

I'm not aware the six-month delay on Direct-to-Consumer Advertising ever became a "law"

This is an old article (2008), but raises the point that a six-month delay in DTCA is "left to the discretion of the individual company".

--------

pharmamkting.blogspot.com/2008/07/can-moratorium-delayed-dtc-ad-refer-to.html

Can a Moratorium-delayed DTC Ad Refer to a Drug as "New"?

Last month, WSJ Health Blog reported that "Drugmakers [Merck, Pfzier, J&J, to name a few] called before Congress to explain their direct-to-consumer [DTC] ads have agreed to wait six months before advertising newly approved drugs to the general public."

But I wonder if marketers in these companies have has asked themselves this question:

Given DDMAC’s policy that a new drug can only be new for six months after marketing launch, does that mean that brands who observe a 6-month or longer DTCA moratorium cannot claim "new" in their consumer ads?

That was a question recently posed by a client to my long-time colleague and Pharma Marketing Roundtable member, Mario Cavallini, Manager of Competitive Intelligence at Rosetta Marketing, who answered: "Interesting question; I don’t know whether anybody’s put those two together before."

The FDA guideline that a prescription med can only be "new" for six months comes (I believe, but could be mistaken on this) not from firm legislation but from "case law" pattern of rulings by DDMAC [Division of Drug Marketing, Advertising and Communications; the FDA division responsible for overseeing drug promotions].

In any event, the “six months for ‘new’ status” rule predates the PhRMA DTC Guiding Principles, which introduced the moratorium. Strictly speaking, the Guiding Principles only call for “an appropriate amount of time to educate health professionals about a new medicine or new therapeutic indication before commencing the first DTC advertising campaign” (by which, the Guiding Principles specifically means broadcast media and print advertising, but not Web sites and online media). How long and how broad the moratorium should be is left to the discretion of the individual company and brand. Six months is typical, but some have a one-year policy, some shorter.

PhRMA offers no guidance on whether the “new” clock starts at FDA approval, brand launch, or campaign launch. However, according to the FAQ page at DDMAC, the clock starts at campaign launch:

DDMAC generally considers that "New" is an accurate description of the marketing phase for six months from the time a product is initially marketed. This should be distinguished from the time the product is cleared by FDA for marketing.

So, on the one hand, it seems clear that the 6-month “new” clock starts at the end of the moratorium. But remember that the PhRMA guidelines only cover so-called mass media. DDMAC does not make such a distinction; if a brand puts up a brand Web site and runs banners within days of FDA approval, and then six months later starts running TV ads with “new” in the creative, I really can’t say whether that will be a problem or not.

Given that the point to the PhRMA moratorium is to allow marketing to HCPs before the messaging to consumers kicks in, my GUESS is that DDMAC would start the "marketing clock" at product launch, not campaign launch. That is, as soon as HCP marketing begins, that product is marketed and the 6-month clock starts.Will this compel companies that observe a 6-month moratorium to NOT launch a Web site for the drug until the end of the moratorium? I don't think so because the FDA and the industry have always considered brand web sites as labeling, not DTC advertising.

--------

Incidentally, according to Wikipedia, Direct-to-Consumer Advertising of prescription drugs is permitted in only two countries: New Zealand and the United States.

I recall reading back last summer that they FDA may also review said advertising.   

If this is in effect based on marketing launch -  not clear on whether they would use the date of the PR or initial sales rollout.  Either case - we're looking at late summer then.  Unless they get an approval to move earlier.  These are, after all, "Guiding Principles" -  not law?

[kc]

Petech good comment. like I drunk I had to buy some more shares today at 50% off. Who can't pass up a half price sale. your comment is right on target.

"I'm happy to get credit-card-default-rate interest on my shares" 

That interest rate buys additional shares in MannKind.

[bobw]

Mar 18, 2015 13:35:30 GMT -5 petech said:

I have a question, how often is short interest updated on the bloomberg terminals?  I have a friend who can access it; but the 90.7M short shares / 17 days to cover are probably static from the last time reported.  Thoughts?

I really don't know how shorts plan to cover that many shares.  I thought the idea was to use bear raids to cover...but that doesn't seem to be happening.  Don't get me wrong, I'm happy to get credit-card-default-rate interest on my shares...but I don't know how they dig themselves out of this hole.  Sure, no drug starts out with $5B in sales...so early sales reports in the quarterly calls can be used to fear-monger....but IMO you have to be absolutely convinced this fails to have a short count this high.  

At least the 9M of shares from BOA should come back soon.  Unless we extend that financing and let them keep the shares longer.  But we're in a much better risk position now...so I am assuming the refinancing of that debt will be on better terms.

I just don't get it.  91M shares short, volume/share price movement is laughable today so the Zacks/Street press didn't do anything, and all anecdotal evidence is that Afrezza is a game changer by both doctors and end users....so it is only a matter of time before sales multiply....don't the shorts want to start covering soon?  I just don't get it.

Final question, is there an easy way to track how many shares are available to short and at what % in the various brokers?  It would be interesting to keep track of that.  Fidelity is "call us" at 28.5%...that's all I got.  This is down from "call us" and 31.5% recently.  

I think that the number of shares available to short is pretty obvious.  If it were large, the interest rate would come down.  As long as the rate is a couple of points above the overnight repo rate, I would not expect that there are too many shares available.

[babaoriley]

Mar 18, 2015 9:31:40 GMT -5 kc said:

Scotta, Your point on DTC is a good one. But my view is that Sanofi can't even do their work well to start advertising until they have 3 lines up and that all Endo's and GP's have been seen and educated. This also is true of the diabetic instructors who teach diabetics how to control with insulin. We are in a launch with the early adaptors leading the way with their viral blogs and postings. So from my 10,000 ft. view things don't rely for awhile on script count. 6 to 10 months from now they are important.

The three lines up is very important.  I believe they can open their marketing spigot much more once they know they have three lines in business.  Until then, caution is the better route.

[gwb]

Table doesn't paste well , but next dissemination date is March 24 at 4pm for short interest as of March 13 .

www.nasdaqtrader.com/Trader.aspx?id=ShortIntPubSch

Publication Schedule for 2015

 

Settlement Date       Due Date- 6 p.m.  Dissemination Date after 4 p.m., ET

January 1/15/2015 1/20/2015 1/27/2015
1/30/2015 2/03/2015 2/10/2015
February 2/13/2015 2/18/2015 2/25/2015
2/27/2015 3/03/2015 3/10/2015
March 3/13/2015 3/17/2015 3/24/2015
3/31/2015 4/02/2015 4/10/2015
April 4/15/2015 4/17/2015 4/24/2015
4/30/2015 5/04/2015 5/11/2015
May 5/15/2015 5/19/2015 5/27/2015
5/29/2015 6/02/2015 6/09/2015
June 6/15/2015 6/17/2015 6/24/2015
6/30/2015 7/02/2015 7/10/2015
July 7/15/2015 7/17/2015 7/24/2015
7/31/2015 8/04/2015 8/11/2015
August 8/14/2015 8/18/2015 8/25/2015
8/31/2015 9/02/2015 9/10/2015
September 9/15/2015 9/17/2015 9/24/2015
9/30/2015 10/02/2015 10/09/2015
October 10/15/2015 10/19/2015 10/26/2015
10/30/2015 11/03/2015 11/10/2015
November 11/13/2015 11/17/2015 11/24/2015
11/30/2015 12/02/2015 12/09/2015
December 12/15/2015 12/17/2015 12/24/2015
12/31/2015 1/05/2016 1/12/2016

[petech]

Absolutely KC.  And I'm going to turn around and lend those all back out.  I'm getting 20% and compounding it...I am like a Visa card for the shorts.  Unfortunately the borrowers under these terms never do that well...but hey...nobody is putting a gun to their heads. 

[dreamboatcruise]

Fair amount of shares seem available to short (and Schwab still not offering anything for mine). Does that mean that today's drop is some longs giving up rather than a bear raid?

[kc]

Fidelity is still paying 20% for short shares as of this am.

[dreamboatcruise]

Mar 20, 2015 10:50:31 GMT -5 kc said:

Fidelity is still paying 20% for short shares as of this am.

Schwab is still paying me for the ones previously borrowed, but I transferred some other shares very recently and they have not offered anything for them.

I'd be interested if Fidelity has borrowed more shares from anyone in last week... but perhaps no one has unborrowed shares over there.

[goyocafe]

Mar 20, 2015 11:01:51 GMT -5 dreamboatcruise said:

Mar 20, 2015 10:50:31 GMT -5 kc said:

Fidelity is still paying 20% for short shares as of this am.

Schwab is still paying me for the ones previously borrowed, but I transferred some other shares very recently and they have not offered anything for them.

I'd be interested if Fidelity has borrowed more shares from anyone in last week... but perhaps no one has unborrowed shares over there.

I moved mine to Fidelity on Monday when Schwab lowered to 12%. The transfer completed yesterday and were immediately borrowed at 20%.

[gomnkd]

Mar 20, 2015 11:41:44 GMT -5 goyocafe said:

Mar 20, 2015 11:01:51 GMT -5 dreamboatcruise said:

Thanks for the reminder. Just initiated the transfer from wells fargo to fidelity. let me at least get paid while waiting.