ANI Pharmaceuticals (ANIP)

[bagel123]

Do you really think ANIP will be bought in 2025? If so, how much?? I have been waiting a long time for this to happen.

[Just the facts maam]

That makes two annual meeting where ANIP has left a BOD seat vacant. I imagine it will get filled this year through a partnership or acquisition.

[Just the facts maam]

Silvr, there are a lot of moving parts and may not include a change of control. . The filing states that fundamental changes include but are not limited to transaction or series of related transactions in connection with a merger, consolidation, share exchange, combination, reclassification, recapitalization, acquisition or liquidation.

I noticed that they removed the second ANIP party from the ANIP v CGON docket. Party # 2 is missing.

Regarding the lead borrower, ANIP Acquisition Company is listed an Initial Subsidiary Borrower.

[Just the facts maam]

I think

George Carlin says it best.

[silvr_surfr]

That sounds right JTFM. What an incentive for the convertible bond holder. The timing is suspicious. They sure have been in a hurry to get here. Does this suggest that a change of control is imminent so they can convert the most shares? Am I reading the filing correct that JP Morgan Chase is one of the primary bond holders? I am thinking about submitting an SEC complaint and you need to have the name of the target company.

On a separate note, I see in the filing the below statement:

On August 13, 2024, the Company, as lead borrower, entered into its previously announced senior secured credit agreement...

Why do they say "lead borrower"? Is this another indication that we have a silent partner like appears to be the case in the CGON suit?

[Roddy4]

if this is the explanation , then we are in front of a totally manipulated stock where fundamentals do not count and everything is possible. What a nightmare!

[Just the facts maam]

Something that I just noticed. According to the Senior Convertible Note filing dated August 13, 2024.
Adjustments to the Conversion Rate in Connection with a Make-Whole Fundamental Change.

ANIP is now hovering around PPS ($57.01) which would trigger the maximum share issue for conversion An extra 4.0478 shares per $1,000 for the maximum 17.5407 shares for a $1,000 note.
The adjustment table is on page 60 of the filing

SEC filing

his could be what is driving the unjustified PPS decline.

[silvr_surfr]

Right, 6 cent difference between bid and ask on another down day with relatively high volume. What a bunch of crooks. I can only hope that no insiders are buying because they are in a quiet period.

[Roddy4]

Yes. And share price went down to 58!

[north40000]

Phase 4 trial of Cortrophin gel Pr announces today.

[Just the facts maam]

Jp2011, I believe they need to increase the authorized shares available for a partnership, especially if the partner will take an equity position in ANIP. It is evident that some type of deal was formalized after the Q3 2023 earnings release, as ANIP went into quiet mode relating to the three NDAs (TEZRULY, INZIRQO and the partnered drug) Keeping quiet might reduce the assessed value of the deal which reduces the associated tax implication. I am sure there are other possibilities, I guess it will all make sense when the PRs start coming out.


JMHO

[Jp2011]

JTFM,
Why do you believe they would have to wait until after the annual stockholders meeting to make an announcement? What would warrant any holdback of news based off the items on the ballot? I do not understand.

[Just the facts maam]

ANIP is getting noticed in the UK, as well.

ANI Raises Generics Guidance As Exclusive Prucalopride Drives Growth

[Just the facts maam]

I agree that they may have used AI. The info is not vetted, as ANIP has yet to mention either drug.

At least ANIP is getting more interest.

I wonder how long after tomorrows meeting before we start hearing announcements.

[silvr_surfr]

JTFM, check out this analysis of ANIP. Smoking something. Seems like it could be all AI.

Valens Research

[silvr_surfr]

Thanks, so probably being done in parallel with FDA approval and commercial preparations, I guess we will have a little bit more time to wait. It would be awesome if Nikhil got questioned about this on Tuesday, but probably not.

[Just the facts maam]

Silvr, it looks like the average Trademark review is about 6 months.

[Just the facts maam]

It appears trademark has no bearing on the approval, but it will be need before launching the drug.

[Just the facts maam]

I find it interesting that Simply Wall Street pegs ANIP's Fair Value (FV) PPS, when looking at discounted cash flow, at $466.43. Obviously that is not what we can expect, but I found it interesting how it compared other pharma/biotechs on a PPS basis. ANIP was deemed more valuable than AbbVie (FW of $426.25), JNJ (FV $328.10), BIIB (FV $441.01) and NBIX (FV $388.59). Looking at what the other companies are trading, once the manipulation has reduced and a partner is announced +$150 PPS is a possibility.

These comparators appear to exclude Libigel. Just to give you an idea of where ANIP should be trading.

[silvr_surfr]

JTFM, do you think they would get the trademarks registered before or after FDA approval?

[Just the facts maam]

Funny Roddy4, the day after you enquire about Libigel. ANIP makes a new application for the Libigel trademark, which they let expire in 2016.

Watch what they do not what they say.

[Just the facts maam]

It looks like it is happening. It will be interesting to see who the partner(s) is. I imagine they will take an equity stake in ANIP, where sales, new drug regulations and patent approvals could lead to a potential buyout in the future.

JMHO

[Just the facts maam]

Thanks Silvr, I see that they refer to 2017 for Libigel, looks like a typo and should have been 2011. I see that Dr Goldstein uses Androfemme, I imagine the FDA will require large safety data for it, as well, as it is in a different concentration and a cream.

[silvr_surfr]

This seems like a relevant and timely recommendation:

AAFP Recommendation

[silvr_surfr]

I checked the European trademark office and it was registered in the United Kingdom on 5/15 as well. This is a mature market for a product like this. Can this be really happening?

[silvr_surfr]

Wow, didn't see that one coming. Great news! I hesitated sharing this, but now I will. It is a great write up on testosterone use for women by Dr. Goldstein who was part of preparing the recent treatment guidelines.

Testosterone Therapy

[Just the facts maam]

Looks like the partnered drug is indeed for Libigel. ANIP just revived the Libigel trademark application on May 15th.

Libigel

GLTA

[silvr_surfr]

Thanks for the reminder JTFM. Perhaps, a deal has been delayed to understand specific impacts of the new administration's tariff and pricing initiatives.

[Just the facts maam]

No new information found, so far.

[Just the facts maam]

Let's not lose sight of the fact that ANIP stopped discussing and making press releases regarding the NDAs after the 2023 Q3 earnings release. There is obviously a larger news that the approvals that have caused them to go silent. Hopefully we find out soon after the annual meeting is completed.

[abh3vt]

My guess is that Meridian Ventures has been a seller, perhaps in size recently. They have been consistently selling down their position over the past few years and they were selling in March 2025 at current price levels:

https://www.sec.gov/Archives/edgar/data/1023024/000110465925023609/xslSCHEDULE_13D_X01/primary_doc.xml

Here are the past few 13D/A filings:
https://whalewisdom.com/filer/meridian-venture-partners-ii-gp-lp

[Just the facts maam]

This is what imagine the institutional longs see.

Of all the pharma/biotechs on a per share basis, ANIP ranked 7th in Revenue per share in Q1 (excluding companies getting milestone payments)

Symbol -Name - PPS yesterday's close - Revenue/Share Q1 2025
REGN - Regeneron Pharmaceuticals Inc. Common Stock - $574.16 - $28.39
UTHR- United Therapeutics Corporation Common Stock - $308.07 - $17.69
BIIB - Biogen Inc. Common Stock - $123.16 - $16.64
AMGN - Amgen Inc. Common Stock - $270.45 - $15.15
LLY - Eli Lilly and Company Common Stock - $746.06 - $14.16
VRTX - Vertex Pharmaceuticals Incorporated Common Stock - $432.00 - $10.78
ANIP - ANI Pharmaceuticals Inc. - $$62.00 - $10.05

This is without sales from Inzirqo, Tezruly and potentially CGON royalties and a third partnered NDA.

GLTA.

Just riding out the

[silvr_surfr]

Thank you JTFM for your thoughts here. What a shocker. I have heard about "selling the news" but this is something else entirely. It will be very interesting to see how Nikhil addresses this at next Tuesday's H.C. Wainwright conference.

[Roddy4]

What about Libigel ? Any idea of when we can get info?

[Just the facts maam]

The flow chart on the draft indicate that certain orphan drugs and low-spend Medicare drugs are excluded from Single Source drug selection for negotiation.
See page 9 of the draft.

https://www.cms.gov/files/document/ipay-2028-draft-guidance.pdf

[Just the facts maam]

I would be highly pleased if any of ANIP's drugs made the list of drugs renegotiations. For 2028, up to 15 drugs covered under Medicare Part D or Part B will be selected for price negotiation, followed by up to 20 additional drugs covered under Part D or Part B drugs for 2029 and later years. These are the drugs Medicare spends the most on. These are blockbuster drugs. .
On the 2027 drug list, Otezla was the lowest Medicare expenditure at almost $1 billion. I am okay with any of ANIP's drug making this list, as PPS will be much higher than we are seeing today,

Since ANIP often targets patients who are refractory to first line treatment, there may not be large savings for Medicare, likely putting ANIP below the radar, at least for a number of years.

Looks like the selected drugs get 7 years from approval before they would even be considered in the selection process for negotiation.

JMHO

[Just the facts maam]

Regarding stock is manipulated by hedge funds and Institutions own 107% of the float, I don't know the retail percentage. The naked shorts are at risk of getting squeezed and this looks like a last ditch effort to cover the shares the shorts have to pay back. The hedge who is covering the cap call transaction is also looking at keeping PPS low and may be helping. Due to the lack of available share on the open market they are trying to trigger stop losses. I expect some institutions, who are not covering, are picking up shares as well. ANIP selling only in the US, for the most part, is not really affected by Trumps announcement on drug pricing.

I agree the quietness around the two drugs is suspect and I imagine it is tied to company who funded the third NDA

I expect it will fly after the annual meeting. Likely announcement regarding INZIRQO and TEZRULY will follow and maybe even a major partnership.

[bagel123]

JTFM, I have owned ANIP of many years maybe 10 maybe more. I've read that this stock is manipulated by hedge funds, what does that mean? Institutions own 107% of float, what does this mean? Why would they want to keep the stock low? So they can buy more? I don't get it. This has been going on for YEARS i can't believe it so they can accumulate and then when they have "enough" shares they are just gonna let it "fly". Seem like there is just something wrong. Why would ANI sit on 2 NDAs with NO mention at all? Confidential? All this sounds very wonky

[abh3vt]

Asking some of the experts on this board for any possible issues for ANIP regarding the new CMS guidance relating to IRA drug price controls. Concerns over proposed new language hit HALO this am. Leerink downgrade PT to 47 from 63

"Risinger noted, "We are downgrading HALO from MP to UP and lowering our DCF-derived PT from $63 to $47. We adjusted our discount rate from 8% to 12% and lowered our terminal growth rate from -15% to -25%." The analyst further explained the rationale behind the downgrade, stating, "The catalyst for our downgrades is that CMS issued draft guidance for 2028 IRA drug price controls that creates risk that hyaluronidase combination products may not be protected from IRA price negotiations for 13 years after combo approval."

The Leerink Partners analyst also highlighted that the CMS draft guidance language suggests a reinterpretation of the protection period for combination products, which could lead to earlier-than-expected price controls. This change poses a significant risk to Halozyme’s product portfolio and future revenue projections. However, Risinger clarified that no changes to revenue projections were made at this time, as the final guidance from CMS is expected in the second half of 2025."

[Brusselsspirit]

My feeling is it's Trump announcement this morning that made pharmaceutical companies go down. I've been in ANI for almost 10 years and sold 100% at the open today... No idea what the impact will be but I'm fed up with his game (Trump). Staying on the sidelines for now, might re-enter when there's more clarity. Still a good company but made much more money with the rest of my portfolio in the last 12 months. Wishing you all the best and hope for you that I made the wrong call. Will still keep a close eye on the board.

[Just the facts maam]

I agree it is ridiculous. ANIP is one of a handful of pharmaceuticals who's revenue topped $10/ share in Q1, quietly sitting on two NDA approvals INZIRQO and TEZRULY, which are now on the market.

Institutions own 107% of the float and are likely trying to trigger stop losses before any announcements.

When a stock hist a 52 week high of $77 due to good new and is driven down 20% in less than two days, it is pure and simple market manipulation by hedge funds, And with a feckless SEC, no one will stop them, so why wouldn't they. It is a rigged game, and all retail investors can do, is take a seat in the back or watch.

GLTA

[Jp2011]

this is infuriating and beyond ridiculous but i have no one to blame but myself. I told myself if this thing ever gets back into the 70's SELL and run but i didnt.

Once AGAIN here i am.

[Just the facts maam]

INZIRQO is also covered by Medicaid.
Two of the following preferred products need to be tried first.
It looks like they will have to try Diuril (chlorothiazide) suspension first.

[Just the facts maam]

Medicaid is covering TEZRULY, t least for hypertension. Prior Authorization (PA) is required with patients having tried two of the following:

clonidine patches, IR tablets
doxazosin
guanfacine
methyldopa
prazosin
terazosin

and

PA request is to include reason terazosin capsules cannot be used, before product will be approved.

Medicaid coverage

[Just the facts maam]

Take aways for earnings release.

INZIRQO and TEZRULY are still in their back pocket. Though are available through many major pharmacies. Obviously are cautious not to ask about the drugs. Pretty easy to beat estimates when info is held back.

ANIP's GAAP EPS would have been $1.47 had they not bought out the royalties for $17.25 million cash.

From a epidemiological perspective, the addressable market for ACTH therapy between $8.2 B to $10.B.

[Just the facts maam]

ANIP is not alone as promising pharma/biotech stocks. VRNA suffered the same fate though they got a climb from their earnings before getting dragged down starting May 6th. Going from close of $72.25 on May 5th to close of $63.32 on May 9th. I think they are trying to trigger stop losses for both stocks. Others with less promising results were not hammered nearly as bad.

According to Yahoo Finance Institutions hold 108.27% of the float. I imagine there is some naked short selling going on.

https://finance.yahoo.com/quote/ANIP/holders/

Personally, I would like to see ANIP indicate their intent to buy back their convertible notes. ANIP's shares would likely hit $96.34 quickly as the note holders would be looking to trigger the ability to convert the shares (130% over the strike for 20 days)

[Roddy4]

Any idea why the share price is collapsing despite a strong quarter?

[bagel123]

I am a little worried that they are going to be sold for $128 per share and it will still go down 5%

[big bambino]

One of the few drugs to beat qtr after qtr and still go down 4%.

[bagel123]

*****Breaking News**** ANIP just cured all diseases......ANIP stock falls 5% on this news! Sure hope someone buys this soon