Replies to post #6175 on ANI Pharmaceuticals (ANIP)

[Just the facts maam]

Yodle, hope you had a good Christmas.

Thanks for the info on your colleagues interest. Very promising indeed. It sort of validates Biosantes projection to grow Libigel from 4 million prescription (just by switching off label and compounded prescriptions) to 9 million prescriptions when an FDA drug is approved gaining more acceptance by physicians.

Are you able to estimate a timeline moving forward on any announcements re Libigel development?

There are a number of possibilities impacting potential time lines but I think you will see some movement at some point this year.

Much will surround the motive for keeping the discoveries quiet. My thoughts are that it relates to the FDA SPA agreeement for NDA submission post efficacy disappointment in the two efficacy trials. It could also relate to a potential future buyout by Abbvie, Abbvie and Teva, or possibly even Pfizer, as talk at the time was that Abbvie was spun off to be sold to Pfizer at a later date.(All speculation of course).



The low outstanding share total mostly concentrated in 10 institutional holders pretty well ensures the deal will pass if recommended by the BOD.

As for timelines, I am watching for the following:

1) The new patent applications, particularly the specifications supporting the Breast Cancer Risk reduction claim could be revealing. I expect this new patent application to be published on the USPTO site in approx. 4 months.

The new commercial production patent application should soon be out. I will provide any clues.

2) I will also be watching for an PDUFA date assigned to Abbvie. If they use the Priority Review Voucher (PRV), they have to give the the FDA 90 days notice prior to using the PRV. Then I believe within 30 - 45 days the FDA will set a PDUFA date.

I fully expect announcements to come out prior to this date. A run upon share price should ensue. How much information is released will determine the size of the run up.

In 2014 they created a $250 million dollar shelf offering and had a secondary offering allowing certain share holders to sell up to 3,500,000 shares.

$143.5 million of the $250 million was used for the convertible notes. I believe a large number of these shares still are available and will be transfered/sold most likely to Abbvie when a partnership or sale is announced. If it is a partnership, look for MVP Meridian to give up one of its seats.

If Abbvie is looking to acquire open market shares, even though they have done well in keeping things quiet, the corti franchise is on the horizon and potential positive news regarding that and Cold Genesys phase 3 trial results due this summer should make the acquisition of these shares more expensive.

3) Abbvie and Amgen go to trial this July regarding Humira patent protection. Following the trial Amgen could give their 180 notice prior to launching their biosimilar. In addition new drugs will start being launched in 2017 that have beat Humira in head to head trials for some indications.

We may see some defensive action with Abbvie bringing Libigel up to bat.
Seeing that anything can happen in court, I don't believe Abbvie will want to wait for the 180 day notice to send the FDA the 90 day notice to use the PRV.

Question for the Board.

I have been in since BPAX days. Original entry $76.68 (wife's account), bought more at $18, bought almost 80% of shares at $7.08. All prior to merger. Family's break even is approx $12.5.

I will probably sell a third in the run up to the PDUFA date and keep the rest for a buyout or even better if they are not bought out, a long term high paying dividend stock. The buyout price will be predicated on if they buyout before the PDUFA date, if they wait to see what sales look like.

To put things into perspective, Abbvie paid $21 Billion (3X Peak Sales) for Pharmacyclics with potential peak sales of $7 billion. Now they had approx. $1 billion in sales at the time but they still have to grow it to $7 billion, and it is facing competition that may reduce this number.

The recent ANACOR deal with Pfizer was one approved product with peak sales of $500 million (Anip excluding Libigel will surpass this) and an drug with a pending PDUFA date and peak sales estimates of $1.7 billion. Assuming a 10% discount for the possibility of not getting approved. You are looking at approx 2.5X peak sales in their $5.2 billion buyout.

In Libigel, you are looking at more at peak sales of at least $15 billion (conservative estimate for all indications and no competition). They didn't keep the discovery quiet for shits and giggles. And at least $3 billion annual run rate within 1 year, most likely more, just by switching off-label and compounded prescriptions.

Considering the above, if Anip had taken it all the way it could easily justify a $30 to $40 billion buyout offer on the open market, probably more as it would attract multiple suitors.

Since ANIP stopped short of analyzing the data and Abbvie, most likely, took it the rest of the way. They are more like partners with a likely buyout in the $15 and $20 billion. At approx. 15 million shares when the convertible notes are included. We are probably looking at a Buyout of between $1000 and $1333/share. (JMHO)

In my honest opinion, if Trump makes good on the 15% corporate tax rate and the one time repatriation of overseas money. Abbvie would be well advised to close the deal before the changes take affect. Before a company like Pfizer throws a crap load of money at Anip forcing the BOD to put the deal to a vote.

Obviously there is a lot of speculation in the numbers provided. But it gives you a good idea as to why I an not going anywhere, until the Libigel tale is revealed.
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JMHO



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