Just read the following message on X : FDA APPROVES LABELING CHANGES TO MENOPAUSAL HORMONE THERAPY PRODUCTS
- Risk statements related to cardiovascular disease, breast cancer and probable dementia were removed from the “boxed warning” - RFK Jr.: “By removing these boxed warnings, we ensure that women receive accurate information about hormone therapy—free from exaggeration or fear”

650K shares exchanged today. Re initiated a position, let's see where we go from here...

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.

Results are out. All good except Yutiq/Iluvien for Q1. Interesting update just now in CC by Steve (CFO). CGON trial will be on July 21 this year. If you want to listen it's around 30 minutes into the call.

Jefferies initiated coverage of ANI Pharmaceuticals (ANIP) with a Buy rating and $80 price target The firm expects continued momentum for the shares, driven primarily by Cortrophin Gel and generics. The setup for ANI relative to expectations is favorable, especially in Q1, the analyst tells investors in a research note. The firm believes investors underappreciate the company’s transition towards branded rare disease products and the impact it is having on its growth and margins.

JPMorgan initiated coverage of ANI Pharmaceuticals (ANIP) with an Overweight rating and $85 price target ANI is a specialty pharmaceuticals company with a “well-positioned and durable” portfolio of branded and generic products, the analyst tells investors in a research note. The firm sees a “long runway for growth” for Cortrophin Gel, the company’s lead product, with room for additional uptake in ophthalmology, which JPMorgan says is benefiting from an increased commercial footprint, and other indications, including acute gouty arthritis. The analyst believes ANI will generate sales and earnings growth well ahead of its peers.

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

https://investor.anipharmaceuticals.com/news-releases/news-release-details/ani-pharmaceuticals-reports-record-third-quarter-2024-financial

Fyi Mallinckrodt reporting on Tuesday morning 

This stock is manipulated like crazy. It's obvious when you look at the rest of the market. I don't know how this is acceptable. Very, very frustrating.

https://investor.anipharmaceuticals.com/news-releases/news-release-details/ani-pharmaceuticals-present-new-data-highlighting-membranous

Didn't know you recently continued to email them and I'm sure you have enough material to build a case should we go there. Let's think positive and hopefully we'll know more soon enough !

Thanks

Hi JTFM, did you ever share your key findings with the analysts following ANI ? I guess some would be interested to know and inclined to ask more direct questions during the quarterly calls. Tezruly would be a good example of that. Q3 call is in less than a month...

These were the ones present in the last quartely call:
Les Sulewski - Truist Securities
Gary Nachman - Raymond James & Associates
Vamil Divan - Guggenheim Securities
Oren Livnat - H.C. Wainwright & Co.
Tim Chiang - Capital One

Also sending a note to IR (or Nikhil, board members, ...) could be an idea. Even if they don't reply, it shows that some people are closely monitoring what their are doing (and not saying).

My biggest fear is that there's a plan in place that will leave the small investors out of the big reward. Have seen that 15 years ago in one of my first investments when I knew little about investing (forgot the name of the pharma company). They literally managed to sell the company way below its actual value by assigning special plans to management.

It seems to be on 25 shares. Let’s see. Not much is surprising me anymore with this share.

Understood.

Thanks

Thanks Jtfm but not sure I understand. What’s the rationale?

Jtfm, Silver you have no idea how much I want to share your enthusiasm around a buyout (I’m heavily invested) but there’s something that doesn’t make much sense to me: why would they bother with an acquisition process of a relatively small player (Alim) if something as big and as transformative as Libigel was in the cards in the very near future? The addition of Alimera seems to be a lot of organisational hassle, even if accretive, and wouldn’t make a huge difference towards a potential buyer. Happy to get your views on this. Thanks

https://investor.anipharmaceuticals.com/news-releases/news-release-details/ani-pharmaceuticals-announces-fda-approval-and-launch-4

PRINCETON, N.J. & ATLANTA--(BUSINESS WIRE)--Sep. 11, 2024-- ANI Pharmaceuticals, Inc. (NASDAQ: ANIP) (“ANI”) and Alimera Sciences, Inc. (NASDAQ: ALIM) (“Alimera” or the “Company”) today jointly announced that they have scheduled the closing of their transaction pursuant to the companies’ previously announced Merger Agreement for before the market opens on Monday, September 16, 2024.

See it now… Not good for both companies, at least on the short term.

Silver, can you please share a link ? Can’t find anything on this so far.

Thanks

Hi Silver,

Found this regarding the legal actions : https://trellis.law/doc/215794328/subpoena-for-a-civil-case-for-attorneys-docketed-on-08-29-2024 . Anything you don’t already know ?

Clear, understood.

Thanks !

JTFM, in your last SA analysis, you write the following "According to Drugs.com - Prescription Drug Information hydrochlorothiazide capsules currently sell for between $12.81 and $13.12 per 30 capsule prescription. The only oral liquid form of the drug should capture at least 5% of this market. Assuming prescriptions are priced around $130, ANIP could be looking at revenues for the drug exceeding $250 million." Can you explain how you come to the 130$ prescription pricing ? I'm not well versed into the US prescription system but the tenfold price vs the 30 capsules price seems high to me (don't know if it makes sense to compare them). Thanks again for all the insights you share with us.

I kind of agree with both of you. Thanks for sharing.

JTFM, Slvr first I'd like to thank you for all the valuable insights you've been sharing the last few years. I've been following ANI since 2015 with ins and outs and have build a sizeable position (according to my means) since 2 years now. This is certainly partially thanks to the valuable information you've been sharing all these years. So thank you for that. I would be interested to have your thoughts on the following: with MNK being in so much trouble there's a good chance that they'll have to sell their assets, Acthar included. Should Acthar be sold to a big pharma with a large and experienced sales team, existing relationships with prescribers, etc wouldn't it be a very concrete threat for ANI ? This might not happen overnight but it could have a strong impact on Cortrophin's future growth. Any thoughts ? Many thanks in advance.

Same for me ! Congrats to all longs and a special thanks to JTFM for sharing your invaluable knowledge and research with us for the past years…

Apparently we’re talking 5 shares… https://www.nasdaq.com/market-activity/stocks/anip/after-hours-trades

I’m not too experienced with this but I guess that, if approved, we should see Corti in this list: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=report.page
Looking at the amount of approvals per day in previous days there should be more then the 2 current additions for today…

Glad I did these last 6 months and will continue to accumulate in the coming days /weeks. Like what I heard. Thank you all for your thoughtful contributions !

Almost all in since Tuesday...

Indeed...

LD,

Thanks for the headlights regarding EBC on ANIP board, I bought in earlier this week.

According to you, What's the real reason behind the IPO ? Looking at major acquisition(s) ? There's no need for an IPO to modernize your IT systems...

Any pronostics on short term appreciation potential ?

Thanks again

According to the following article https://www.marketwatch.com/press-release/infantile-spasms-therapeutics-market-2020-global-industry-overview-by-market-size-share-price-revenue-emerging-growth-factors-and-key-regions-forecast-to-2026-2020-01-23 « In 2019, the global Infantile Spasms Therapeutics market size was US$ 138.9 million and it is expected to reach US$ 178.4 million by the end of 2026, with a CAGR of 3.6% ». I don’t know how reliable these figures are...

Interesting: http://www.aetna.com/cpb/medical/data/700_799/0762.html

Hi all, just curious to have your thoughts on this: how come there is zero mention of us on any of the MNK articles/comments on SeekingAlpha ? If we were really about to potentially take 50% of Acthar’s market, someone should worry a little, no ? Even the very same analysts that follow us don’t raise the point when they ask questions during MNK Q&A... Seems very odd to me.

Fyi earnings call transcripts are now available on SeekingAlpha. Art seems pretty convinced of corti approval... Will be interesting times...

15% of the company traded today, this is HUGE !!! Have been following ANI for 3 years now and really like the story but it’s the first time I’m disappointed. Still beleive it’s another buying opportunity. Time and Corti will tell.

XYOSTED approved ! Check articles on SeekingAlpha

Didn’t know the FDA was working on Saturdays...