ANI Pharmaceuticals Inc (ANIP) Options

Very odd. Here are a couple more odd things. Not sure if this is signal or noise:

1) ANIP worked with a branding company to develop the Tezruly name and now it is discontinued?

Tezruly Branding

2) ANIP has (or had) another Princeton office. Looks like this is becoming a hotel, so maybe they moved to the other (500 Alexander Park) Princeton location.

20 Nassau Street

Tezruly, is still listed in ANIP's Products page. Odd for a drug with a discontinued marketing status.

Tezruly

Interesting info regarding Meridian Therapeutics. As for the deal, we should be hearing soon enough. The steps that ANIP is taking is consistent with them believing the deal will be accepted by investors. Why else would you discontinue Tezruly let alone delay launching it?

Thanks and congrats on your return on investment with CORT.

Another possibility, jtfm. The other BOD members of AMLN also departed once that auction process completed. Some or all of them founded another company, CORT. I bought 3K shares of CORT(Corcept) at $1.34 in 2011, now selling at $45.43 per share. Cortisol and rest of pipeline are in development. Any interest?

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.

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

Here's another possibility building on the idea that Ampersand and Bourne Partners are somehow involved in a deal. So Bourne Partners lists "Millicent Partners" as one of its current investments. When you look at them, they were formed in 2018 by the Carlyle group together with a bunch of former Warner Chilcott people. Femring (Estradiol) was their first acquisition. Their next one was Intrarosa (DHEA). They are targeting women's health with hormone-based products.

Where it gets interesting is that Warner Chilcott bought P&G's pharmaceutical unit which included Intrinsa (testosterone patch). They pulled the product in 2010 most likely because of the lack of FDA approval (safety reasons). Could the band be reuniting to launch Intrinsa behind Libigel's safety data? Carlyle Group has deep pockets and a global footprint.

Millicent Pharma

Thanks Silvr

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

Good point, Silvr.

JTFM, here's another clue about a potential female testosterone product launch. At the upcoming World Congress on Menopause. Susan Davis is giving the plenary lecture on "NOT JUST SEX: OTHER ROLES FOR TESTOSTERONE IN WOMEN" on 10/19.

19th World Congress on Menopause

Roddy4, everyone has to make their own decision about risk/reward. If you look to the analysts, most have us at a strong buy with a share price target well north of where we are now. Of course, Trust went off the reservation recently and lowered its target based on the delay in closing the Alimera deal. I hope ANIP stops doing business with them.

A buy out aside, there are several catalysts that can propel the stock. I am sticking around to see them play out.

We are discussing about buyout , new products , strong business performance but the share price continue to deteriorate. There must be something wrong with this company that is hidden to us. I cannot find any other explanations

It seems to be on 25 shares. Let’s see. Not much is surprising me anymore with this share.

Pre market showing down 20% on SA! No news I see posted. I have seen some crazy post and pre market moves before…But this one is nuts. Let’s see what happens at open. Any thoughts?

Pre market showing down 20% on SA! No news I see posted. I have seen some crazy post and pre market moves before…But this one is nuts. Let’s see what happens at open. Any thoughts?

Pre market showing down 20% on SA! No news I see posted. I have seen some crazy post and pre market moves before…But this one is nuts. Let’s see what happens at open. Any thoughts?

On the plus side, doesn't this also mean that there is not a "less complex" submission that they are looking at since we would have seen an announcement for it?

Thank you JTFM for looking into this. I still don't get the concept of two separate headquarters, particularly for a small company like ours. I agree with you that the secrecy around what it is for is telling. They have $10M in synergies to realize out of the Alimera deal, so you would think an office consolidation would be low-hanging fruit. As you point out, perhaps there is something else going on.

I guess with the size and scope of the Libigel studies, it was probably too much to ask for the FDA to meet a PDUFA date within the 10 months following acceptance of the application.

Though they are less common, I found another example of another US company setting up a commercial headquarters in the US. In February 2015, Phoenix Integration set up a commercial HQ to more effective support for its customers globally. While its Corporate HQ remained in Virginia. So it is possible that by itself would not be confirmation of a buyout. The secrecy and tying up almost all authorized shares, hampering any future business development is a strong sign of pending buyout.

Phoenix Integration Establishes Commercial Headquarters

Silvr, it looks like they took is as security interest for the loan. ANIP has done this in the past.

On second thought, this may be because of the recent financing deal with JP Morgan Chase. What I did notice though is the many of the legacy patents are now assigned under the ANIP Acquisition company. This may be indicative of a potential deal.

Thanks JT

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.

One more proof point regarding Tezruly. The Novitium terazosin patent was assigned to JP Morgan Chase as the "administrative agent" on 8/14/24.

Good possibility, Silvr.

Understood.

Thanks

The acquiring company will apply to market the drug. As I understand it, ANIP has to first discontinue their marketing rights, before the FDA can give marketing authorization to another company.

Thanks Jtfm but not sure I understand. What’s the rationale?

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

Thanks JTFM. Great find.

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!

North, as you mentioned, I too have thought about a multi player deal, similar to the Amylin buyout. Thanks for pointing out the Walsh connection. I guess we will soon see how things play out.

I’ve pointed out, here or there, that Patrick Walsh was on the Amylin BOD(with Dr. Alex Denner, now of Sarissa Capital Hedge Fund that controls BOD and management of AMRN) when AMLN was auctioned to BMY/AZN a decade 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.

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

Jtfm, Silver you have no idea how much I want to share your enthusiasm around a buyout (I’m heavily invested) but there’s something that doesn’t make much sense to me: why would they bother with an acquisition process of a relatively small player (Alim) if something as big and as transformative as Libigel was in the cards in the very near future? The addition of Alimera seems to be a lot of organisational hassle, even if accretive, and wouldn’t make a huge difference towards a potential buyer. Happy to get your views on this. Thanks

Good points.

Thanks JTM. Lots of synergies, not to forget Androgel. Even Tezruly has a connection like I mentioned since Abbott (Abbvie spun out) was the one to first launch terazosin.

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

I think the delay is linked to the pending deal. As for Tezruly's trademark, Corti was approved November 1, 2021 and did not get registered until February 15, 2022.

Good info regarding Parkinsons, Dementia and glycolysis, many of these patients might need an oral solution.

It is also of note that we have still not seen the announcement of Tezruly, but did see the one for the prescription Head & Shoulders. I see that the Tezruly trademark is still pending and they recently asked for an extension. Either this is caught up in some patent litigation, or it is somehow part of a pending deal.

Interestingly, the original "Hytrin" product was launched by Abbott. There are also several clinical trials underway exploring the use of Terazosin for Parkinson's and Dementia. Maybe this is where the real interest lies for any potential suitor. The research is showing that the drug increases glycolysis in the brain which reduces cell death. Sounds like we should all be taking this if we are to keep our wits about us.

I doubt we see an update until the big announcement comes out.

Looks like the jobs page was just a glitch. It is back up and still has 33 positions available.

Also, no corporate update posted since June.

ANIP has been adding jobs daily to their careers page over the last couple of days having 33 open positions as of yesterday. The rest of the site is up, except the jobs page. It may be routine maintenance, but I can't help but wonder if the pending update relates to the partnered NDA approval.

Just something to keep an eye on.

Thanks Brusselsspirit.

https://investor.anipharmaceuticals.com/news-releases/news-release-details/ani-pharmaceuticals-announces-fda-approval-and-launch-4