ANI Pharmaceuticals Inc (ANIP) Share Price

Congrats to all of us longs.....only 3 points away from the 1 year low! Lets Goooo!!!

Are you sure those are not the long term incentive stock grants that you saw the sec filings for last week?

Insiders keep selling and share price goes down.

Thanks Silver.

Maybe this is what we have been waiting for:

Launch of HRT Club

I think I mentioned this once before. It is significant that Besins is involved. Looks like they have a ready-made distribution network. Now they just need the product. Who the heck knows.

I thought the same (deja vu).

Thank you JTFM. For the desire domain, didn't the placebo beat the DHEA one (deja vu)? Regardless, it does not look like this one is going anywhere. Bummer.

Results from the Pill PLus trial.

Looks like only the desire domain has pvalue approaching 0.05.

Results

These drugs can be differentiated from the generics and the reference drug, which helps getting physician to prescribe them and eventually name recognition.

Sovuna does not appear to have patent protection, where as Tezruly and Inzirqo do.

Could be that they are being spun out, but it could also be part of big news to start a partnership. ANIP still has Tezruly on its product page, yet Inzirqo is not. However, the NIH National Library of Medicine list Inzirqo but not Tezruly.

Inzirqo

I guess we should be finding out soon.

Thanks JTFM. It is curious why these three have been branded where others were not. Spinning them out might be a reason, but, is it six months now since Tezruly was approved? Like you said, there better be a good deal for us coming out of this.

If ANIP's Sovuna goes for over $17 a tablet, I have been greatly underestimating the price for Inzirqo an Tezruly. This could get real interesting.

Sovuna Price

LOL, Genentech (Roche subsidiary) gets an original new form of a drug approved and they announce it the next day.

Genentech PR

All I can say is, ANIP 's reason for withholding info better have shareholder value as the driver.

Thanks Silvr.

Thank you JTFM. The trademarks are a good tell for who are the players.

Nice to see that we are green on a red day for the market. Hopefully, we can put the 50's behind us. Here is a bullish technical analysis I recently found:

Technical Analysis

SIlvr, fyi, neither Organon, Merck or ANIP have a trademark pending with the "sexual dysfunction" listed in the Good and Services.

However, AbbVie, Abbott Labs, Teva and Pfizer all do.

In treating HSDD alone, I would say Organ would be a good fit but when looking at most of the other potential indications for testosterone, I think Merk would be interested in the additional indications.

Thank you JTFM. The dates are very telling. Doesn't it make sense that it would get executed through their Organon spin off? Pill Plus would also have a home here.

It all makes sense now. Merck is almost definitely the partner.

ANIP announce the agreement to acquire Corti from Merck on September 21, 2015.

Corti announcement

The following day ANIP obtains Confidential Treatment Order extending to filings associated to Libigel up to March 31, 2020.


CT order to 2020

Looks like there was a gap between March 31, 2015 and September 22, 2015 where a CT order was not in place.

CT order expires March 31, 2015

Hard to argue that the Corti deal with Merck was not tied to Libigel.

Thanks Silvr, regarding the NYT story, it takes longer but you can read it through the source code. The text gets broken up by code for links etc... But it is readable.

Nothing in there regarding CV or BC benefits. It laments the lack of an FDA approve testosterone for women, while men have 31 options.

Here is an interesting excerpt They are intrigued by the fact that women have testosterone receptors all over the body — including the heart, brain, muscles and bones — which suggests that it is linked to the health of these organs, Dr. Davis said, but we aren’t sure yet why or how.

They say that testosterone is effective in approximately 50 % of women in treating HSDD . Mainly because there are so many other variables which may cause HSDD. For best results they recommend testosterone along with seeing a sex therapist. Interestingly they recommend obtaining a testosterone base line trying to see where the levels are in relation to when a patient was more sexually active. Maybe more related to the level of deviation as they age.

Personally, this may be true for HSDD, but I believe in the end getting to the average premenopausal range will drive the reduction in CV and BC events. If so, it could create a market in premenopausal women, as well.

They still advise against pellets and compounded testosterone, recommending a testosterone gel.

The New York Times has a recent article about female testosterone, but it is behind a paywall. Don't know if it is positive or negative.

Testosterone Therapy

More interestingly, Pfizer is now in the game. They are a big API supplier, but could there be something else?

Health Answers from Pfizer

Correction the dosage form for Inzirqo is powder for suspension , not oral solution.

Cool. Did not see that. Merck is a likely partner given the Cortrophin relationship. They have to be happy with the deal we struck with them on that.

There is sure a lot going on with this sleepy little company of ours.

Silvr, I find it interesting that in the "Case Parties" section near the top of the docket, they list Christina B. VAVALA of Polsinelli PC as an attorney but do not state who they represent. Could it be the silent partner? Maybe just a coincidence, but Polsinelli PC seem to have a good relationship with Merck having recently hired some of Merck's lawyers and represented Merck in both the Vioxx and Nuvaring litigations.

I saw that, but it only says a letter was sent to the judge. Not sure if this was at the request of the judge, or if they are responding to something from CGON. It could also be something we initiated, but it does not make sense then why the new Farnan brother was added for personal injury claims. I guess we will know soon enough. Things will get interesting leading up to the July trial.

I still believe the $200M offering CGON did out of the blue was to settle this, but it is telling that a couple of months later there is no settlement.

Silvr, if you look at the February 4th docket entry, it looks like they going towards mediation.

Yet another new lawyer, Joseph J. Farnan, joined our CGON lawsuit team. Looks like we have all of the Farnan brothers now which comprises almost all of the firm. What makes his addition noteworthy is that he is a personal injury guy. ANIP stated they would be seeking personal injuries so maybe there is a there there, Here's his bio:

Joseph J. Farnan

I agree, this is definitely the most private,, publicly traded company. Two NDAs down and one to go.

Wow, thank you JTFM. I have never heard of a company not disclosing good news like this. It is also another branded entry which I don't think is a coincidence. I hope any deal is worth our while since the stock has had a miserable year while the company has performed well.

The Guggenheim Conference was a yawner. I don't get why they are spending so much time doing these events when you can just read the powerpoint deck. So many conferences with institutional investors and notihng to show for it in the stock price. Get a clue Nikhil.

Thanks for the update Silver.

ANIP is now sitting two NDA approvals. On January 28, 2025 Novitium's INZIRQO oral solution of Hydrochlorothiazide was approved.

Approval

To approved drugs and just presented at Guggenheim, yet crickets.

Thanks JTFM. I have been out of pocket for a while.

There continues to be lots happening with the CGON lawsuit:

a) Another pro hac vice attorney (Robert Isakson) added to our team (1/27)
b) We will be deposing Morgan Stanley (led the CGON IPO) in March
c) We sent a letter to the judge responding to a question about mediation - not sure if this was initiated by him or CGON (2/5)

With all of the attorneys and documents, this must be costing a fortune. Glad to see that we are in it to win it. Still suspect that we have a partner.

The last FDA approval posted on their site is from January 22, 2025. As a rule the FDA try to post the day after an approval. Is this one of the impacts of Trump's broad actions? If so, we are in the dark as we await a decisions on two NDAs. It is bad enough that ANIP is withholding info on Tezruly, and the other NDAs. This could make it even easier for them to hold back info.

Approvals

Can someone advise me on a situation of a stock I own. Tried speaking with Merrill and only came away more confused. I have shares in GNS @ $.56. now my portfolio shows GNSRT @$.078.

Genius Files Rights Offering to Fund Bitcoin Purchases
January 22, 2025
12:35 PM ETPublished January 22, 2025 12:35 PM Eastern Time
MT Newswires

12:35 PM EST, 01/22/2025 (MT Newswires) -- Genius Group (GNS) said Wednesday it filed a registration statement for up to 90 million subscription rights and an equal amount of shares issuable on the exercise of the rights.

The company said it will distribute one transferable right to buy a share for $0.50 apiece against each ordinary share held to shareholders at no charge.

Net proceeds will be used to buy Bitcoin for the company's Bitcoin Treasury, Genius Group said.

The rights offering expires on Feb. 14, unless extended, according to the company.

Shares of Genius Group were down nearly 6% in recent trading.

Price: 0.64, Change: -0.04, Percent Change: -5.88

MT Newswires does not provide investment advice. Unauthorized reproduction is strictly prohibited.

Does this mean I can purchase an additional 19,000 @.50, or cash in the additional shares for .068. Is this correct. Would appreciate any guidance as this is 10x's over my pay grade🤣

Transactions like Millennium acquiring 561,251 shares at $54.16 on January 14, 2025 is what keeps ANIP's PPS artificially low. Imagine what PPS would have climbed to had it been open market buys. They now own 5.2% of ANIP.

Millennium acquisition of shares

I expect other's are also trying to get in.

Checking over ANIP's corporate presentation, I see that they project Acth therapy (Corti and Acthar HP) to increase by $127 to $131 million in 2024 . Looks like ANIP captured approx.67% of the increase. Even better is that Lalwani stated that they have figured out the process to get the drug to those who may benefit most from it.

Wow, I did not realize he was the former President/\Chairman of the Board for Endo/Par. It is hard to believe all of the high fives were referencing the quarterly results. Something "great", "amazing", and "awesome" happened at the conference. Wonder how long we will have to wait to find out.

Thanks Silvr, Campinelli obviously has close ties to Samy and Stephen Carey from their time at PAR. Looking at his bio on the Bourne Partners, ANIP is somewhat mirroring his growth strategy for PAR, except it is going beyond generics. A company that was acquired for $1.2 Billion and with a few smaller acquisitions sold for $8.2 billion three year later. TPG who owned PAR made 6.5 X their initial investment in the deal.

Paul’s leadership drove the company to significantly increased total revenue. During his tenure, Par and Endo acquired Michigan-based JHP Pharmaceuticals, established a business office in London to serve as Par’s entry point into the European generics market, and completed its acquisition of an active pharmaceutical ingredients (API) facility located in Chennai, India. Paul also shaped the company’s strategic focus on organic growth through investments in hard-to-produce generic assets and technologies, a highly specialized branded business, and a concentration on differentiated and intelligent product selection.

I still think any finalization on a deal will be contingent on an FDA approval for testosterone. A PDUFA update sure would be nice.

Here's a brand new article from Dr. Susan Davis. She is highlighting other benefits of testosterone besides hsdd:

Not Just Sex:

Only the abstract is available. I believe her articles to date have emphasized that testosterone is only to be used for hdd following the published menopause guidelines. Is this a change for her? Regardless, it helps our cause.

Thanks for finding this JTFM. They were telling us the truth, but their meetings were obviously not in public.

I looked at who commented on Nikhil's post and there are some very fascinating connections:

Kurt Nielsen is the President of Pharmaceuticals International, LLC. When you search his name with testosterone you find that his company makes testosterone cypionate injection for Wilshire Pharmaceuticals

PII Testosterone

Paul Campinelli - Bourne Partners. I have already spoken about the link between our company and this.

Mario DI Giacomo - President Steroids and Highly Potent Products BU at Axplora and Managing Director Farmabios SpA. They are an API supplier of testosterone.

Perhaps the gang got together to finalize the testosterone deal, There was a congratulations from the Bourne partner so that might mean that the deal was made.

Thanks BB.

Thanks Silvr, Lalwani made a post on Linkedin about the JPM conference. Looks like Chad Gassert also attended. They may have been on a business development trip.

Thanks big bambino, Patrick Walsh is a busy guy.

A news story "Alcami Announces CEO Transition" for ANIP from PR Newswire was triggered at 1/13/2025 11:12 AM.

Thanks for the updates JTFM. I was not available to listen this time. A team-building shopping trip is a good explanation as any for them first saying the business development guy would be there, then just Mary Pao and then neither of them shows up.

Here is a favorable article from Zachs. They sure bounce around, but it is a good read for anyone having any doubts about our future, even without all of the hidden assets we have been discussing.

Zachs Research on ANIP

So Mary Pao was not at JP Morgan to present. Maybe she was there as part of company shopping/partnering trip.

Listened to JP Morgan presentation. No mention of Tezruly or other NDAs.

They want to send the message that hey are now and will be predominantly a rare disease company with support from a complex generic business.

It almost looks like they will sell or out licence the NDAs and use the funds to finance rare disease growth. I am ok with this but why the secrecy.

Unlike other CEO's lalwani will not give peak sales estimates but speaks patient numbers that can possibly benefit from Corti. Good to hear that acute gouty arthritis has an addressable patient population of 300,000. This iworks out to an addressable market of over $2 billion. How much of the addressable market ANIP can capture remains to be seen, but even 10% is $200 million in sales for the one indication.

Maybe we find out more this week.

Me neither

Truist maintains a Hold rating. Never seen such a strange context for a stock...

Forbes article "Three Under-The-Radar Growth Stocks Poised To Double In 2025" list ANIP as on of the three stocks. I commented giving info regarding Tezruly and the other two NDA's not factored into ANIP current revenue estimates for 2025.

Article

Hopefully, Forbes will help get ANIP some traction.

I agree the numbers look strong and Lalwani once again left lots on the table. He has to be bound by some type of disclosure restrictions. If there is deal to be announced at the JPM Conference it would be by the larger partner. AbbVie does not present until the 15th. I have also seen deals announced a week or two after the conference, to avoid competing with all the other pharma news.

I did like seeing 14% growth in Corti revenue over Q3 almost $60 million in Q4.

Hopefully, some has done their homework and ask Lalwani for an update on Tezruly and the other two NDAs. If Lalwani repeats the following, as he did to Oren Linvat of H.C. Wainwright:

"So, Oren, on the 505B2s, we will share more when we have meaningful updates to give. But there's no linkage between the litigation spend and the launch of 505B2 products. But we will share updates on that when there are material. "

Hopefully, they follow up with:

What do you mean by meaningful? And when can we expect a meaningful update?.