silvr_surfr
4 hours ago
I agree there are multiple players. Carving out Tezruly is an example of this. Regardless of the players, as you point out, this has been in the works for quite a while. Patrick Walsh joined in 2018. There has to be something they are waiting for. The best example would be FDA approval of a female testosterone product.
They could also be spinning out the cell genesys legacy products. CG 0070 is the closest to market with final Phase 3 results due at the end of the year. With Breakthrough Therapy and Fast Track designations, hopefully they get it to market quickly. I think I read that the FDA has already allowed it to be used on an emergency basis.
GVAX is also not yet dead. Meridian Therapeutics has been created to launch GVAX as a maintenance treatment for myeloma. The founders are the scientists that have done the development (through Phase 2) at Johns Hopkins.
Meridian Therapeutics
Lastly, can't forget the Pill Plus which has completed Phase 3 testing in the EU. This would fit well with whomever is picking up the female testosterone.
As I am writing this, it dawns on me that, while it is frustrating waiting for something to happen. It is actually to our benefit that they wait for these opportunities to achieve key commercial milestones so we get the best deal. For example, a 5% royalty on a likely $1-2B CG0070 business would mean $50-100M in operating income. Using a conservative P/E of 10 and a 20M float, this translates to a share price increase of 25-50 pts alone. Of course, if we actually recover the CG0070 assets in their entirety, then it would be much greater than that.
Just the facts maam
12 hours ago
Interesting possibility, but I think North may be onto something about the possibility of ANIP being part of a multi-player deal of some sort such as the Amylin acquisition by BMY and AZN. I found it interesting that Walsh sat on Amylin's BOD during the deal and would not be surprised if another similar deal deal gets announced for ANIP.
Biosante facing delisting on June 4, 2012 executed a 1:6 reverse split it still kept the authorized shares total at 200,000,000.
On July 18, 2013, ANIP executed another 1:6 reverse split which left ANIP with only 33,333,334 authorized shares. The only way this makes sense is if there was a deal on the table and ANIP only need shares to help with business development for finite period of time.. The end of time appears to be approaching, as almost all of ANIP's authorized shares are now accounted for.
Walsh was not in the picture back then. and the initial deal may have gotten scuttled with concerns over Testosterone CV safety. However, ANIP's patent application for CV and Breast Cancer risk reduction were halted in 2018, when informed that they had to file each risk reduction in separate patents. Such a filing would have exposed the fact that work had continued on Libigel and who the partner would of been. Though I could be wrong, I personally believe AbbVie to still be one of the partners and with the addition of Elizabeth Powell, I would not be surprised if Merck were the other partner.
JMHO
Just the facts maam
24 hours ago
Roddy4, I agree with Silvr, In my opinion, something is definitely up. Though PPS activity has been frustrating, it doe snot necessarily mean something is wrong. So few shares make this company's PPS very easy to manipulate. It has gone up quickly without news in the past, as well.
If ANIP does not get bough out immediately, it appears that ANIP expects to get bought at a future date, or ANIP will be so flush with cash that they have no need to issue shares for future business development.
As Silvr stated, you have to make your own risk/reward assessment. I have been in since 2011 and seeing the testosterone discovery to the end. Hopefully we won't have to wait much longer.
GLTA
Just the facts maam
4 days ago
Apologies BB, upon rereading the indenture regarding note conversions, I realized the PPS above $96.34 did not have to be consecutive but had to occur 20 times in a 30 day trading period including the last trading day of the quarter. So it looks like the conversions earliest date would come in January.
June 1, 2029, a Holder may Convert its Notes during any calendar quarter (and only during such calendar quarter) commencing after the calendar quarter ending on September 30, 2024, if the Last Reported Sale Price per share of Common Stock exceeds one hundred and thirty percent (130%) of the Conversion Price for each of at least twenty (20) Trading Days (whether or not consecutive) during the thirty (30) consecutive Trading Days ending on, and including, the last Trading Day of the immediately preceding calendar quarter.
If this is the case. The announcement will be made that will drive price up. Probably won't see a big increase in the lead to an announcement.
silvr_surfr
6 days ago
I have mentioned this connection before, but revisited it this morning. There are too many coincidences with MedPharm, to not consider them somehow as part of any deal:
1) Patrick Walsh is also their chairman.
2) They are located in Guildford UK, the same place where Alimera Sciences is located.
3) They merged recently with Tergus (see below). Afterwards, Ampersand Capital (Patrick Walsh) and Bourne Partners (participated in Novitium deal) have a majority interest.
4) The press release for the merger indicates - "Expanded capabilities will also include the development and manufacture of hormone-based and highly potent drugs at the Company’s GMP manufacturing facility in Durham, NC."
5) Patrick Walsh is quoted as saying "Pharma clients have been seeking a reliable, integrated service offering for their ophthalmic, topical and transdermal development and manufacturing projects. This merger creates an immediate option with two organizations already well-positioned in the industry.”
6) MedPharm has MedSpray technology. There actually was such a product approved by FDA in 2010 (Axiron® topical solution (Eli Lilly and Co., Indianapolis, USA). Maybe this is a more desirable form for a woman and fits with a 505b application.
MedPharm-Tergus Merger
Just the facts maam
6 days ago
It is getting harder and harder to hide the fact that ANIP is getting bought out.
Tezruly's Marketing Status was just discontinued. Marketing Start date was August 1, 2024. Even though, on September 24, 2024, they submitted the patent expiration info related to Tezruly, the first approved oral solution for an alpha -1 beta in the world with patent protection until January 18, 2041.
Discontinued
Tezruly Patent Protection
Prescribing details show Marketing Start Date
This explains why ANIP did not launch it.
Watch what they do, not what they say!
Just the facts maam
1 week ago
Brusselsspirit, Silvr, covered the points consistent with a large announcement being made in the future. I say buyout because they have tied up all their shares, with almost no shares remaining for future business development. If not being bought out they must be they must be planning to buy back the notes as they continue to grow.
The Alimera deal may not be insignificant to the partner, but will be important to ANIP, if female testosterone is not approved, or if the company is splitting.
ANIP is obviously in some type of quiet period, logic dictates it is major news.
silvr_surfr
1 week ago
Brusselsspirit, I agree it is a house of cards what with buying Novitium to bring in-house drug development capability and then shortly thereafter proclaiming to be a rare disease company too and then merging with Alimera. All the while, having a hodgepodge of legacy opportunities with Libigel, Pill Plus, CG0070 and GVAX perhaps.
While nothing is ever certain, several things indicate something is up:
1) They will not disclose that they have a new "commercial" headquarters.
2) They have not disclosed the approval of Tezruly when they have others.
3) They have not updated their Corporate Presentation since June where these have been getting updated at least on a bi-monthly basis.
4) Consistent with this, they have slowed or stopped their participation in investment conferences (compare last year's Q3 schedule to this year).
5) An extension was filed for the pivotal Libigel clinical trial.
6) Someone paid for a simultaneous global PR campaign for the use of testosterone for women which includes a paid spokesperson (Kate Winslet)
7) There was an army of lawyers participating in the Novitium acquisition.
8) Our Chairman, Patrick Walsh, is a private equity guy (Ampersand Capital) and has led multiple deals (I looked at some of these and they have been done together with Bourne Partners who helped with the Novitium deal).
9) MVP Capital has stuck with us from the beginning and is on the inside (former chairman) and knows what is coming.
JTFM can probably add more of these clues. I agree with his observation about the mystery 505b NDA being funded by a third party. Given the timing he outlined, we should know soon enough what is going on.
GLTA
Just the facts maam
1 week ago
Silbvr, not sure if you already mentioned this, but according to Net Gather Market Research "Unveiling Insights, Shaping Strategies: Your Guide to Market Success and Growth", Alimera Sciences and Allergan are known for their expertise in treating retinal diseases. Looks like Alimera would compliment Allergan's (AbbVie) Eye care division.
Alimera Sciences and Allergan are known for their expertise in treating retinal diseases, while Bausch Health and EyePoint Pharmaceuticals provide novel therapies that improve drug deliverability.
Booming Ocular Drug Delivery System Market Sector: Market Analysis and Growth Projections till 2031.
With Allergan being based in Ireland, it stands to reason that they would have a strong presence in the UK. Therefore if AbbVie is buying out ANIP, it would explain why the Alimera open positions in the UK were taken down shortly after the acquisition by ANIP was announced.
Combined with Dr Snabes connection, I would be highly surprised if AbbVie is not involved, at least in some part, in ANIP's acquisition
Just the facts maam
1 week ago
Roddy, I think your patience will be rewarded over the next 8 weeks.
If the partnered drug is female testosterone, the larger partner will want to present their findings at the American Heart Association Scientific Session scheduled for November 15 to 18 in Chicago. Ironically, if AbbVie is the partner, it is their back yard. If it is a buyout the announcement will be based on their timeline.
FYI, there is a reason MVP has not sold any shares in a while, and Blackrock is now ANIP's largest shareholder. So we are in good company.
Good luck to all.
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