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.

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:

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.

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

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.

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

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:

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.

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).

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.

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.

I agree, I think the new comes out in the New Year with partnership announced in the lead up to the JP Morgan conference in January.

Thanks Silver, I agree that we probably won't hear anything. It is their MO. Lalwani also stated that he figured the matter would go to trial in 2025. Though, if the judge came down heavily in ANIP's favor, a settlement may be more likely, especially as they get ready to submit an NDA.

Something to consider, even if ANIP was in the process of being bought out, Trump winning the election may cause a delay, as businesses may wait to see how things shake out. I know of at least one company (private equity owned) where a deal being brokered, with several serious bidders, has been pushed back a year.

If AbbVie is involved, they need a win after their stock took a $35 drop following the November 11th announcement that emraclidine, a treatment for adults with schizophrenia experiencing acute exacerbation of psychotic symptoms did not meet their primary endpoint. It was part of their $8.7 billion Cerevel Therapeutics acquisition announced December 2023 and closed in August 2024.

Here is an interesting excerpt from the Q3 earning CC, Which point to good growth in Corti sales due increased affordability.

Roddy, that is why with some companies, like ANIP, you have to watch what they do, not what they say to understand its true value.

I agree it is bullish, thanks Silvr.

BB, wishing you and the other board members and their family a happy holiday as well.

Silvr, I agree the follow-up was not cheap. These were the study procedures for the first five year, I imagine it was extended to an additional 5 years for 3,656 participants. The following is from the AJH article.

Roddy, very few analyst really do deep dives into a company.

They go off what the company provides in the presentations and filings. In August, one analyst asked for an update on the 505(b)(2) NDA's. Lalwani responded that they would provide an update later, when it was material. As if getting approval for Tezruly (a week earlier), or latter submitting the patent protection to 2042, were not material events. The approval was intentionally omitted from their 10-Q filing for Q3. Only a deal, of some kind, preventing the disclosure of these events excuses this type of behavior from our CEO and the BOD.

If ANIP is not even going to cough up info on Tezruly, I doubt they will do the research to ask pointed questions regarding testosterone.

JMHO

Silvr. here are two videos.

In What is Libigel? - Dr. Goldstein quotes Dr. Snabes saying that if the FDA wants 10 years of data, we are going to do 10 years of data. (1:47 into the video)

In Biosante CEO Stephen Simes at 2;00 into the video, Simes talks about either redoing the phase three efficacy study or find another use for their safety data

There may have been another with Snabes himself, but I can't find it.

Bagel, I feel your frustration.

In my opinion, if there was not not some type of deal, partnership or buyout, ANIP would have already announced the launch of Tezruly and the named the drugs in the NDAs, plus their partner and PDUFA dates. Investors armed with this info would drive PPS much higher and Lalwani would be getting a higher price for his shares, allowing him to hold on to more of them.

I find it hard to believe that testosterone is not in play, as ANIP was under no obligation to update their clinical trial results unless they were moving forward with it. Why spend the time and money. Fact is they obtained a certification to delay posting results. As I understand it, this is only granted when and NDA is being filed. They submitted an NDA and someone other ANIP appears to have paid the application fee likely for $3.2 million as it would involve the review of the clinical trial data. Therefore they have an undisclosed partner.

If this partner(s) was not taking an equity stake in ANIP or buying them out, why all the secrecy there is nothing to be gained by the partner and everything to be gained by ANIP.

Watch what they do, not what they say!

Roddy, it also doesn't make sense to sell before announcing the drug approvals.

If North's suggestion is correct we may not get an announcement until the last NDA is approved in Q1, if all goes well.

That sounds extraordinary to me. It would explain why they never disclosed any info Tezruly and the other two drugs.

This company goes against every norm. Something is definitely cooking.

Lalwani is now selling 33,481 shares, knowing full well that he could announce Tezruly approval and provide info on the other NDAs including PDUFA dates which would drive price up PPS, leading to less shares having to be sold.

The deal must be good enough for him to feel comfortable in selling these shares at a discount.

SEC filing

There does not appear to be many extraordinary circumstances that apply. From what I can tell there is a high burden on ANIP to justify the FDA not disclosing the approval. I see that Abbott cited extraordinary circumstances in fighting disclosure safety and efficacy data regarding Humira and lost their argument.

I just found out that it is possible that the partnered drug may already be approved.

According to PART 314—APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG

§ 314.430 Availability for public disclosure of data and information in an application or abbreviated application.

Good point. Off label use, until approved at some time on the future?

Word is spreading. Oprah daily is writing about it.

With over 50% of revenue coming from rare diseases assets in 2025, ANIP is on track to generate at least $800 million in revenue in 2025. This excludes any revenue for Tezruly or the other two NDAs. Analysts consensus is $718.47 million in revenue for 2025 and reaching $802.27 million in 2027.

It will be real interesting if Lalwani was including revenue from Tezruly in his assertion that 50% of revenue would come from rare disease assets.

Good point regarding the need for an approved product to gain insurance coverage.

Another reason to get female testosterone approved. According to The molecular mechanisms of steroid hormone effects on cognitive function

North and Silvr. I find it interesting that Lalwani sated that over 50% of revenue will come from their Rare Disease division. It sounds like they intend to out-licence Tezruly. Which would explain why they have not launched it. An up front payment plus royalties could give them additional cash for the future rare disease acquisition(s) they spoke about at the Guggenheim conference. If that is the case then you will likely see them also include the NDA filed Q1 2024 in the deal.

But who really knows with this unorthodox group.