ANI Pharmaceuticals Inc (ANIP) Options

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

Thanks Silvr, I guess we will find out so. Assuming peak sales would be $250 million/yr. ANIP has already given up close to $100 million in future revenue in this delay. Only a sale or meaningful out-licensing deal could justify this delay. Even the acquiring company would only delay it, if it were part of a larger deal.

Thank you JTFM. It sure looks that way. It will be interesting to see who is licensing Tezruly and why. I have to think it has something to do with its potential treatment for various brain diseases. Of special note, there is a new phase 2 trial underway by a researcher at Cedar's Sinai to look at the benefits in Parkinson's Disease. If you look at where his grants are coming from (see below), you see several companies. Abbvie shows up several times. AND, Cerevel shows up which is now owned by Abbvie. It would make sense that they would want both the female testosterone and Tezruly then for this purpose.

Michele Tagliati Grants

Here is another potential application for Tezruly which may interest any licensee.

Use of Terazosin for PTSD

According to the USPTO site, it looks like Novitium's Hydrochlorothiazide oral solution will be called Inzirqo,, assuming that this is the NDA ANIP submitted in Q1 2024. Though ANIP filed and request for an extension to file a Statement of Use for Tezruly, they made no request for Sezroa. They had made extension request for both at the same time in previous filings. The trademark extension expires December 13, 2024.

With Cortophin-zinc being the only other pending trademark. It looks like the partner will name the other pending NDA (likely female testosterone).

All the ducks are lining up.

Insider have more at stake than we do, so imagine it will be a fair deal. Possibly waiting to sell both Tezruly and the NDA with a Q1 2025 PDUFA date together. The deal should give them enough upfront cash to justify looking at their next acquisition

Thanks JTFM. I sure hope whatever the reason for the extension is that its value to shareholders is worth delaying the launch.

It is looking more like Tezruly is being out-licenced or sold. Last week, rather than file a Statement of Use for Tezruly, ANIP's lawyers filed an Extension of Time to File a Statement of Use with the USPTO.

Extension to File SOU

Tezruly is finally making onto formularies with proper prescribing coverage. The following is from the Premera Blue Cross:

Tezruly (terazosin) may be considered medically necessary for the treatment of symptoms of benign prostatic hyperplasia
(BPH) when ALL the following conditions are met:
• The individual has a diagnosis of benign prostatic hyperplasia (BPH)
AND
• Has tried and had an inadequate response or intolerance to
ALL of the following:
o One generic alpha blocker (e.g., terazosin, tamsulosin, doxazosin, or alfuzosin)
o Generic finasteride, dutasteride, or silodosin
OR
• Documentation is provided that the oral solution is medically necessary (e.g., unable to swallow tablets or capsules)
AND
• The dose is limited to 10 mg once daily

Tezruly (terazosin) may be considered medically necessary for the treatment of hypertension when ALL the following
conditions are met:
• The individual has a diagnosis of hypertension
AND
• Has tried and had an inadequate response or intolerance to
ALL of the following:
o Calcium channel blocker (e.g., amlodipine)
o Angiotensin receptor blocker (e.g., losartan) OR angiotensin-converting enzyme inhibitor (e.g., lisinopril)
o Diuretic (e.g., hydrochlorothiazide)
OR
• Documentation is provided that the oral solution is medically necessary (e.g., unable to swallow tablets or capsules)
AND
• The dose is limited to 20 mg once daily

Premera Medical Policy effective December 1, 2024.

Launch announcement can't be too far off.

I figure there was a PDUFA date scheduled for Q3 2024, which meets their target goals. However the complexity of such a large review likely justified the FDA giving themselves a three month extension (the norm when they give a PDUFA date extension). That means we should see a decision within this month.

Thanks Silvr, I expect a settlement being reached during the pre trial conference which has yet to be scheduled.

... Maybe this is why CGON's stock price took a dump yesterday despite the strong readout on the Phase 3 results.

Motion to Dismiss - Denied. We are going to trial. Must mean we did not accept any pre-motion settlement. Bullish for our side and puts the ball in CGON's court. It will be interesting to see how they communicate this to their shareholders.

Yes, this was my thought too. If you look at the docket, there is a sea of filings and depositions initiated by us. I have to think someone is helping to fund and prosecute the case as well. I looked at the most recent 10Q and legal expenses are not separately reported and are lumped in with SG&A. Given the Alimera merger in Q3, there is no way to see if the legal expenses have grown significantly as part of this case.

Silvr, you pointed out early on that it was odd the had two plaintiffs named Ani Pharmaceuticals. This would be consistent with ANIP intending to sell or spin-off part of the company before the matter is resolved.

Thanks Silvr, going to trial is consistent with what Lalwani said he expected in a previous presentation.

On the positive side, it looks like ANIP will be seeing an inflow of cash from other assets (Tezruly, and or the pending NDAs) to justify shopping for additional acquisition(s).

I just noticed something on the docket for our case against CGON. A trial date has been set with Jury selection happening on 7/17 and the trial beginning on 7/21. That is a long time for this to be hanging over CGON's head. I did not know that it was going to be a jury trial, but I am glad it is, since I would think they would be sympathetic to our position as the inventor getting squeezed out and could award sizable damages.

I don't know if this means that the judge has then ruled not to dismiss the case or that can still yet happen.

Looks like some CGON investors got stopped out. Learned my lesson the hard way many years ago.

Last I checked, CGON had $0.5B in cash. From the lawsuit records, it is clear that we have discovered the market sizing that CGON has done, so we know how they value CG0070. I agree their end game is selling the company, so they want this resolved quickly. This matches with our interest to make new acquisitions. They mentioned an FDA submission in the middle of next year which would likely place approval in 2026, even with fast track status.

It will be interesting to see if we take a cash settlement now to accelerate our rare disease program or hold on for a royalty stream. I would think the net present value of a 5% royalty (excluding any damages) would be at least several $100M at a $2B annual sales of CG0070. Of course there will be.a ramp up in CG0070 revenues so the royalty revenues will not be able to fund any near-term acquisitions (assumes any unpaid milestone payments will be minimal).

Following this stock with all of its twists and turns is better than any soap opera or reality tv show.

Thanks Silvr, regarding Cell Genesys pioneers, I concur.

I figure CGON needs to get the litigation resolved to confirm a buyout price. ANIP has nothing to lose, as CGON royalties it is not priced into current PPS. Maybe they already have a cash settlement deal on the table. It would explain why ANIP is already talking about their next acquisition which sound like it will be as big, if not bigger than the Alimera deal.

Wow, 75% complete response rate for CG0070 in its Phase 3 trial! I don't think you see these kinds of results often, particularly with one of the most difficult cancers to treat. Hopefully, our rights get sorted out soon. It will be interesting to see if there is a settlement before trial, or if we take it to trial with the belief that our case is strong. Hopefully, with these results the CGON team is less greedy and they work out a good deal for us..

Phase 3 Results

Congrats to all the BPAX investors that have stuck through this. I always have to recognize the Cell Genesys pioneers who created this technology that is now saving lives.

Great summary JTFM. I listened as well. Nikhil is a machine. Even though the format was different, he stuck to his script and got all of his points in. Poor Steve did not have any speaking parts again.

Pulmonology is a good choice for any next acquisition. I am impressed with their analytical nature and their market knowledge of the opportunity "funnel" for the different indications. He was the most articulate of any CEO I can recall about the criteria they will use to select an acquisition candidate. It gives me confidence that they will spend the money well and I would think the leaders of any target company would be attracted by this.

Hopefully we get a good report out tomorrow on CG0070 and a favorable outcome from the lawsuit to fund it.

GLTA

In todays fireside chat, Lawani confirmed that over 50% of revenue will come from their three rare diseases assets. He did not say how much above. But this puts ANIPs revenue north of $800 million. Once again talking about synergistic acquisitions to compliment corti's existing sales infrastructure. I would not be surprised if they go after an pulmonology asset.

He also went to potential benefits associated with the New Day Trial for Iluvien in combination with anti-VGEF. Top line readout End of Q1 or early Q2. If positive that take the target patient population from 50,000 to somewhere between 75,000 and 260,000 patients. Currently they only 5,000 use Iluvien.

Regarding Synchonicity for Yutiq. Readout is Q1 2026, if positive, the target audience is 100,000 with only 5,000 patient currently using Yutiq.

Regarding Corti, he confirmed that they believe both ANIP and Mallinckrodt will maintain their duopoly in Acth therapy into 2040's. He would provide the potential acute gouty arthritis market potential but did clarify that they when they first launched it was mostly previous prescribers of Acth therapy. Now they also a growth in new prescribers. Though he did not come out an say it, he pointed to the previous peak of $1.2 billion. Now you have new prescribers and the 1 ml vial treatment . Reading between the lines, the market should grow much more than the $1.2 billion historical peak.

Thanks for the update Silvr.

A second confidential letter was sent back to the judge by ANIP. It sure looks like his pending public notice is his Motion to Dismiss ruling and there is a settlement happening with CGON proposing a settlement in their 11/27 letter and us responding in our 12/3 one. Seems like we should hear something soon, but not ahead of tomorrow's CGON presentation.

I agree CGON would want to settle this since they would not want the albatross of them potentially losing their rights outright in trial as they are presenting fabulous clinical trial results to investors. Perhaps Thursdays conference call and the Phase 3 results were an incentive to get a settlement done then.