ANI Pharmaceuticals Inc (ANIP) オプション

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- Purified Cortrophin Gel is a porcine derived purified corticotropin (ACTH) in a sterile solution of gelatin. It is made up of a complex mixture of ACTH, ACTH related peptides and other porcine pituitary derived peptides.

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:

ANI Pharmaceuticals, Inc. will participate in the 43rd Annual J.P. Morgan Healthcare Conference in San Francisco next month, which is taking place Jan. 13-16, 2025. ANI CEO Nikhil Lalwani will be presenting on Tuesday, January 14 at 2:15pm. Other ANI participants include Chief Medical Officer Mary Pao, CFO Stephen Carey, and SVP, Corporate Development Chad Gassert.

Possibly a coming out party. They have 4 Execs presenting. I imagine they expect a lot of questions. Oddly, Christopher Mutz - Head of Rare Disease is not included.

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:

Four key features of new drug applications (NDA) are linked to the time the Food and Drug Administration (FDA) takes to complete initial reviews of NDAs. Three key NDA features determine the time frames for initial review that would meet FDA’s goals under the Prescription Drug User Fee Act (PDUFA) and its reauthorizations, which authorize FDA to collect user fees from drug sponsors:

• Whether or not the NDA qualifies for the priority review program, which is
generally an expedited program for drugs that provide significant therapeutic improvements in the prevention, diagnosis, or treatment of a serious condition when compared to available drugs. The PDUFA goal for review of a priority NDA is 4 months less than for an otherwise similar standard NDA, for which the goal is to complete the review in 10 months.
• Whether or not the NDA involves a new molecular entity (an active ingredient that has not been previously marketed or approved in the United States). The PDUFA goal for review of an NDA with a new molecular entity is 2 months longer than for an NDA without one.
• Whether or not the applicant submits a major amendment (additional or new information, such as a major new clinical study) while the NDA is under
review. The PDUFA goal for a review of an NDA may be extended by 3
months if the applicant submits a major amendment.

The fourth key NDA feature is whether or not it qualified for one or more of three other expedited programs for drugs intended to treat serious or life-threatening conditions.

US Government of Accountability Report

As I understand it, female testosterone would be considered as a new molecular entity which could of resulted in an additional two months being added to the PDUFA date. Assuming the filing was made September 30, 2023 and the FDA took the full 60 days to accept the submission for review and the FDA gave themselves an extra two months for the review and they requested additional info to qualify as a major amendment, you could be looking at a revised PDUFA date as late as February 28, 2025. Obviously, transparency from ANIP would resolve this question. But we know that it is not in their DNA.

GLTA

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.

Thanks dasgrunt.

So true

Maybe we should stop getting coverage's. it seems every time we do, the share price goes down 🤣

Thank you dasgrunt. We have gained quite the collection of analysts following us now. I guess this is one way to measure our success.

Leerink initiated coverage with outperform rating
https://www.investing.com/news/analyst-ratings/leerink-sets-stock-target-on-ani-pharma-cites-branded-drug-shift-93CH-3766091

Thanks JTFM. This is very helpful. Glad to see them being transparent about the case now. The timing is just odd and they already have $0.5B on hand. I don't think they could fund a settlement and commercialize CG0070 with these monies so they chose the offering. Like you said, a settlement will probably come before or at the pre-trial hearing which I still do not see a date for in the docket.

Silvr, you may be right about the payout. According to slide 3 of their October 31st, 2024 Investor Presentation, it states that their cash runway was expected to fund operation to 2027. Probably looking at a $200 to $250 million settlement.

Investor presentation

According to the related S1 filing

Use of Proceeds:

We estimate that the net proceeds to us from this offering will be approximately $230.6 million (or approximately $268.6 million if the underwriters exercise their option to purchase additional shares in full), based on the assumed public offering price of $33.70 per share, the last reported sale price of our common stock on Nasdaq on December 10, 2024, and after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us.


We currently intend to use the net proceeds from this offering, together with our existing cash, cash equivalents and marketable securities, to fund the research and development of cretostimogene for the treatment of high-risk BCG-unresponsive NMIBC, including the completion of our BOND-003 Phase 3 clinical trial, submission of a BLA to the FDA as well as preparation for commercialization, subject to regulatory approval. We intend to use the remaining proceeds, if any, to fund the further research and development of cretostimogene for additional indications, including current and planned clinical trials, and for working capital and other general corporate purposes. See the section titled “Use of Proceeds.”

Under Risk Factors

Legal proceedings, government investigations and enforcement actions can be expensive and time-consuming. For example, on March 4, 2024, a complaint was filed in the Superior Court of the State of Delaware by ANI Pharmaceuticals, Inc. (ANI) naming us as defendant, seeking a declaratory judgement that a provision in an assignment and technology transfer agreement between us and ANI (formerly BioSante Pharmaceuticals, Inc.), dated November 15, 2010, obligates us to pay ANI 5% of worldwide net sales of cretostimogene. The court has most recently set a trial date of July 21, 2025. While we continue to believe the allegations are without merit and intend to vigorously defend this matter, such litigation could result in substantial costs and divert our management’s attention from other business concerns, cause us reputational damage, negatively affect our stock price and result in monetary damages and future royalty obligations, if and to the extent cretostimogene receives regulatory approval. An adverse outcome resulting from any legal proceedings, investigations or enforcement actions could result in significant damages awards, fines, penalties, exclusion from the federal healthcare programs, healthcare debarment, injunctive relief, product recalls, reputational damage and modifications of our business practices, which could have a material adverse effect on our business, financial condition, results of operations and prospects. Even if such a proceeding, investigation or enforcement action is ultimately decided in our favor, the investigation and defense thereof could require substantial financial and management resources.

I think that they informed investors it was 5% of global net sales at stake.

Great perspective JTFM. That is some serious money to step away from. Everything must be tied to the other (female testosterone) approval.

On a separate note, CG Oncology just announced a public offering with $0.5B in cash already in reserve. The announcement is below. Most of the offering announcements I have seen have said what the money was to be used for. This one does not. Can you say ANIP settlement? Maybe this is why our stock is trading higher this morning.

CGON PublicOffering

With 7,300,000 shares offered, that is over $220M. Sounds like a nice payday for us is coming.

GLTA