Thanks BB hopping everyone here has a Happy and Very Profitable Year!

Thanks !! Happy new year dear friends !!

I would like to wish all my friends on the best board in Ihub, a very and healthy new year for them and all their families, God Bless.

If Lalwani included Generic Motegrity in his assessment that Rare disease would represent over half of ANIP's revenue in 2025. ANIP's revenue estimates should be raised to over $1.1 billion for 2025, excluding sales from Tezruly and the other two NDA's

Novitium gained approval for a generic Prucalopride Succinate. The therapeutic equivalence to Teva's Motegrity, with no other competition. According to Market Edge Dynamics the US market was $350 million in 2022 and expected to grow to $550 million by 2030.

Approval

Market

Word is starting to filter out.

Henry Turner of Investor Hangout describes it as follows:

Nothing is simple and straight forward with ANIP. Chad may still participate, as stated in the Linkedin post. He just won't present. Might be there to answer questions. Mary on the other hand will present on something.

ANIP presented new pre-clinical data highlighting its membranous nephropathy (MN) research during two poster presentations at the American Society of Nephrology (ASN) Kidney Week 2024 in San Diego, CA, October 23-27. Where they had two posters.

According to Mary Pao, the data shed light of the potential role of melanocortin receptors in the underlying disease pathologies within nephrotic syndrome. The research contributes to the development of valuable research tools and models for studying membranous nephropathy. She stated that the findings represent the first steps in ANI’s commitment to advancing the science underlying certain disease pathologies.”

Two poster presentations demonstrate ANI’s commitment to research in membranous nephropathy care

Aside from the NDAs, I wonder if they will announce the launch of a Phase 1 clinical studies. This would show that ANIP is further distancing itself from its generic and specialty pharma roots.

So now the official press release does not have Chad included in the presentation. Always the mystery with these guys.

The Linkedin post even had a slide with photos of the four participants. I agree they are not bringing Gassert and Pao to sit on the sidelines.



Mary could also be there to elaborate on
https://investor.anipharmaceuticals.com/news-releases/news-release-details/ani-pharmaceuticals-present-new-data-highlighting-membranous

Precedent aside, it does not make sense to have Chad there to say we can't talk about specific acquisition targets. There must be a completed deal that will be discussed. This fits with what has been going on the past many months.

In Mary's case, there was also the Cortrophin pre-clinical work that was done, but I think they already mentioned it and it is not anything of investor value at this point.

Lastly, there is still no announcement on the website for the JPM conference. My guess is that the person responsible for posting is out of the office and the execs are excited about sharing this, so got it posted themselves on LinkedIn.

We will know soon enough.

ANIP's top Institutional investors now are
BlackRock
Vanguard
JP Morgan Chase & Co.
and
Goldman Sachs.

JP Morgan revised their ownership from 554,840 shares in Q3 to 1,109,670 shares.

They obviously see it as undervalued.

Slvr, I have looked at a number of transcripts from past presenters and very few list the CMO or CSO as participating, mostly CEOs and CFOs. It is an investors conference.

Mary Pat posted this on her Linked In:

Looking forward to J.P. Morgan in 2025!

Whatever the discussion, it looks like she is excited about it. Let's hope it translates well to an improved valuation.

It is odd how the LinkedIn posts are more timely than the main website. The 1/14 conference has not been posted there and there was never any announcement of the Princeton site either.

It will be great to finally get some clarity on what is going on. We know that it includes some kind of a deal and involves new clinical information.

Good point. New Day readout is not until Q2, so she is definitely there for something else.

Interestingly, both Eyepoint Pharma and MBX Biosciences are scheduled to present at the same time as ANIP. Possibly a coincidence, but Eyepoint manufactures Iluvien and Yutiq. While MBX is a clinical-stage biopharmaceutical company focused on the discovery and development of novel precision peptide therapies for the treatment of endocrine and metabolic disorders. According to Corti's label-

Great news JTFM. Both Chad and Mary's participation are telling. I believe there is an Iluvien read out coming later this year from one of the clinical trials, so Mary must be there for something else of clinical significance. It is most certainly connected to the mystery NDA, it is just a question of for what. You called a JV or co-promotion of testosterone gel a.long time ago and these facts support this.

Of course I am going to be out of pocket on the 14th so may not be able to listen to the call if it gets broadcast.

GLTA

From looking at other presenters, including much bigger companies, most only have their CEO and CFO's presenting. Looks like they are getting ready to answer a number of technical questions, that is where Poa and Gassert step in.

According to their Linkedin page:

AN

Good article supporting ANIP's oral solution strategy, especially for NDA's with patent protection.

Crushed Tablet Administration for Patients with Dysphagia and Enteral Feeding: Challenges and Considerations

Hope you and your family have a happy holiday season as well.
Same goes for the rest of the board members.

Would like to wish everyone a merry Christmas and happy holiday's

Roddy, Bagel, I understand your frustration. If you do exit, I wish you both the best in future investments.

I will be riding it out to the end. Might be a fools errand.

I agree that the buyout in the short-term seems less likely. But I disagree on nothing happenning. Whether it moves the needle depends companies like BlackRock (2,689,712 shares) and (Vanguard 1,348,111 shares). When they want out, all the good news we have had will likely be reflected in the PPS.

Hopefully it will happen soon.

I agree with you bagel123. There are no signs that something big is going to happen shortly.No insiders buying( actually the other way around .. we saw a lot of selling) . I also do not believe an acquisition is around the corner , it would be the first time that an acquisition is made with no insiders buying , no rumors in the market , nothing at all. As matter of fact we have seen the sp declining constantly. Like you I am planning an exit . I have been waiting for too many years.

I agree with you bagel123. There are no signs that something big is going to happen shortly.No insiders buying( actually the other way around .. we saw a lot of selling) . I also do not believe an acquisition is around the corner , it would be the first time that an acquisition is made with no insiders buying , no rumors in the market , nothing at all. As matter of fact we have seen the sp declining constantly. Like you I am planning an exit . I have been waiting for too many years.

JTFM, thx for the response. I know that you seem very knowledgeable about ANI, but the fact is that this stock has done nothing for investors as my $ sits dead with them. What may or may not be the future is very speculative. There has been no sign of anything that would deem otherwise. No significant insiders buys only a few sells, not enough to worry about. Its almost like nobody want this to move up. As i stated the news is always good with new drugs to market etc. Ive heard many time on this board that the institutions don't want it to go up blah blah blah. I believe if they had a cure for cancer the stock would go down or stay the same price. I have owned for 5+ years and has been a terrible investment, i do feel married to it so i guess i will just ride it out

The returns are real, unfortunately the lack disclosure by the company is also real. Possibly, a condition of what ever deal they have in place.

Not launching Tezruly upon approval, sure brings into questions their motto- "Serving Patients, Improving Lives". Just something they may want to consider.

This stock is crap, been here way too long with way too many shares. Management gives shareholders nothing at all. Some holding on for what "may" be in the works, a lot of speculation. Truth is there has been no return this year (-2%). 5 year (-15%). This company always comes out with good news and earning beats quarterly, yet nothing. Seems like a giant scam to me

Great sleuthing JTFM as always. Like you have said before, don't watch for what they say, but what they do. This is great evidence that the Tezruly delay was planned. Sammy must be getting a good deal otherwise. Painful watching the stock near 52 week lows with all of the progress in the past year and material new prospects.

In the 2023 Q2 10-Q filing ANIP recorded the contingency consideration to pay Sammy and company as commencing in 2024 . Meaning they intended to launch Tezruly in 2024, Yet , the following quarter, after filing two NDAs, one financed by a partner, ANIP pushed back the contingency consideration starting in 2025. Certainly looks like the deal for Tezruly, and likely one or both other NDAs, was struck in Q3 2023.

Thanks Silvr. I agree that ANIP is not pulling any punches. The addition may add pressure to reach a settlement.

A big gun attorney, Stephen Rabinowitz, got added to our team for the CGON case. Here's a write up I found on him:

Stephen has been profiled in the “Intellectual Property Trailblazers” list by The National Law Journal, recognizing top legal professionals in the United States who have “moved the needle” in intellectual property law. In addition, he was named Lawyer of the Year for Biotechnology and Life Sciences Practice in New York City in 2024 edition of The Best Lawyers in America©. He is also recognized by Managing Intellectual Property, The Legal 500, and IAM Patent 1000.

The full court press is on. Just like everything else, we have more waiting. I don't think we would take on the added cost of this if we were not bullish in the outcome. Similarly, I don't think a high caliber person like this would take the case, if they did not think they would win.

Looks like rebalancing. Other stocks are having similar high volume.

Almost 1.2 million shares traded at close. More shorts exiting or approval rumors?

I would not be surprised if the downturn over the last couple of sessions was used by many to exit short positions. Institutions should be set for the pending run.

On a side note, BPAX intended to set Libigel at a cost $8-$10/day to treat HSDD back in 2012. I wonder what it will be priced at in 2025, with CV and Breast Cancer event reduction data.

Thank you JTFM. A complicated situation to be sure. I did not remember the connection to Abbvie with regard to the Dudley patent. I suppose this is one more point in their favor as a potential partner. What a day that will be if we actually can make cardiac and/or breast cancer reduction claims. It is good to hear that there can be some patent protection even for HSDD claims.

It sure looks like ANIP has been trading for some time in a downward channel. I thought we would break out of it after Q3 results, but no such luck. Today, it appears we touched the bottom of the channel and bounced back. It was painful to watch, but it looks like we are headed back up. Those algorithms are nasty.

Silvr, I forgot to mention that in ANIP's patent prosecution of administering testosterone to reduce CV events, the reason for denial was that Dudley's prior claims had been assigned prior art (owned by AbbVie). The problem, may have been that this allowed Besins in on a deal. The patent appears to be sitting there waiting to be issued if AbbVie assigns rights to the prior art and adds Dudley to the list of inventors. If Dudley's name had appeared as an inventor on the patent application the secret partnership would have been exposed. The delay may have been linked to AbbVie finding a way to maximize the benefit to AbbVie, at Besins' expense. They also may have secured the prior art by ANIP making the breast cancer reduction claim in December 2015 in their prosecution of the CV patent. Arguably they could be looking at filing new patent applications once testosterone is approved. Paying the USPTO fee, gets the HSDD patent protection as far as 2033, and filing the CV patent (very good chance of approval ) and breast cancer patent applications once approved. This could extend patent protection past 2044.

Even though AbbVie still list Androderm on their products page . The Orange Book shows that it has been discontinued.

Thanks Silvr, it would be nice, assuming there is a settlement, I think it will come close to when CGON is ready to file the NDA or the pre-trial conference, ANIP seeking to revoke CGON's rights to the NDA, as a possible remedy, could cause delays in the FDA reviewing an NDA, which is added pressure .

I can't conceive that a BOD would let this go to trial, where a jury could send a strong punitive message which could tank CGON's PPS. The risk is not worth the reward.

CG Oncology closed its public offering. Hope we get a nice settlement for xmas. Their fiscal year ends on 12/31 so maybe this is a driver too.

Another affidavit was filed on our behalf recently so we are not taking the pressure off. If we don't see a settlement, I suspect this means that we are bullish about winning the case or are holding out for an even bigger settlement.

Oh boy, what a proverbial tangled web. As you pointed out quite a while ago, this must be one of the reasons they needed an army of lawyers for the Novitium deal. I wonder how Sammy is getting compensated for the Tezruly delay.

As I understand it Besins and Unimed (Solvay/Abbott/AbbVie) developed Androgel. With Unimed only North American right to Androgel. Abbott/AbbVie outsourced the manufacturing. This why the subsequent IP has been shared 50/50 between Besins and Unimen/Abboot/AbbVie.

As I understand, it AbbVie currently owns all of Androderm.

Libigel was developed between ANIP and Antares, where ANIP later gained the manufacturing rights. I don't think Besins was involved, as initial patents were assigned to Antares with some Biosante employees listed as inventors(e.g. Simes). The CV reduction patent application did not include Besins or Antares though the Breast Cancer reduction patent application Patent and Breast cancer patent application did not mention anything about Besins and no new inventors were added. Though as it relates to CV reduction, in one patent prosecution the reviewer assign prior art to Robert Dudley (Unimed/ Solvay) I an sure if this is shared with Besins. This does not appear to be the case regarding Breast Cancer reduction. yet, it has not been fully argued.

As you said Besins could be a partner, but if AbbVie is involved, I believe the steps taken were to free themselves from having to share IP rights with Besins.

JMHO

Thanks JTFM. How strange. Hopefully it will all make sense someday. Didn't Libigel and Androgel originally come from Besins? If so, maybe Besins is the eventual partner for us.

Silvr, it looks like Ascend Therapeutics, a Besins Healthcare subsidiary now sells Androgel. AbbVie no longer list Androgel on their products page, but do still have Androderm acquired in the Allergan deal.

https://www.androgel.com/

I agree AbbvIe with Snabes is the lead candidate, but they seem to have transitioned well from the EOL for Humira patent protection. Merck currently appears to need ANIP's assets more.

I would not be surprised if they are involved .

Thanks JTFM. That is good company regardless. It makes sense that a deal could have been struck along with Cortrophin Gel. The Novitium deal came after this so Tezruly would not have been a part of it. Abbvie would be my lead candidate. We have not talked about the new commercial headquarters. Perhaps the deal excludes the high containment Baudette plant (since they already have a supply chain for Androgel), ANIP would need a new headquarter so that explains the new Princeton facility.

CLTA

The Seeking Alpha article titled "Betting Big On AbbVie: A Prescription For Growth And Dividends has a good" has a good graphics of the Patent Cliff big pharma's are experiencing.

I did not realize that Merck was $33.9 Billion of revenue were at risk to patent expiration in 2028 (Keytruda and Gardasil 9). That a huge chunk of their $63.174 Billion in revenue (TTM).

If Merck is ANIP's partner the deal may extend back to ANIP obtaining Corti from them in 2016. Merck has indicated that they are looking for deals up to $15 billion in value. Elizabeth Powell may have been hire from Merck to help facilitate the deal in 2022 following Corti's launch.

Article

The graphic shows a number of big pharma which will be looking to replace loss revenue, but Merck stands out as the one that could use ANIP's assets the most.

Thanks as always JTFM. That is a long time to delay Tezruly. It must be a good deal if it takes until then.

Regarding the FDA review timelines, I found this report to Congress regarding FDA Drug Approvals dated March 2020, which states the following as FDA goal:

Thank you JTFM. This is very helpful. It is good to have the FDA rules working in our favor so we will finally know what happened and learn what will happen next.

Key dates coming up.

If the FDA gave themselves a 3 month extension on the partnered NDA a decision should be made this month. Problem is that if they get a CRL, we won't know about it, as FDA only publishes approvals.

The testosterone clinical trial is in non compliance by more than 1 year for posting results. Within the first two weeks of 2025 look to see if ANIP receives a pre-notice of non-compliance form the FDA. This is something ANIP can't hide, it is publicly posted.

J P Morgan Health Care Conference is January 13-16, 2025. Arguably the best place to announce a deal, especially related to testosterone CV and Breast Cancer reduction. Likely ANIP announces the partner having a representative taking the vacant seat on ANIP's BOD.

January 28, 2025 should be the last day for ANIP to launch Tezruly and not have it discontinued for not launching within 180 days of the marketing start date.

Q1 2025 possible approval of NDA filed in Q1 of 2024.

End of year institutional rebalancing should get out of the way for a good run.

Should make for an eventful 6 weeks.