ANI Pharmaceuticals (ANIP)

[Just the facts maam]

Thanks auh2oman.

[Just the facts maam]

Silvr, keeping their website up to date was never ANIP's forte. The 2023 annual report says the CVR's expired.

[auh2oman]

Another Upgrade ...

ANI Pharmaceuticals price target raised to $83 from $81 at Raymond James

Raymond James analyst Gary Nachman raised the firm’s price target on ANI Pharmaceuticals to $83 from $81 and keeps an Outperform rating on the shares. ANI Pharmaceutials closed the acquisition of Alimera Sciences this week, and Raymond James sees good value from the deal, the analyst tells investors in a research note. The firm likes that the deal is expanding ANI’s Rare Disease franchise with Iluvien/Yutiq, and that stronger ophthalmology presence will also benefit Cortrophin and should accelerate its growth in that segment.


https://www.tipranks.com/news/the-fly/ani-pharmaceuticals-price-target-raised-to-83-from-81-at-raymond-james

[silvr_surfr]

JTFM, Jere's an off-the-wall question. Why do the Libigel CVRs still show up in the ANIP FAQs? Mine were removed from my account, but are they still in play?

[Just the facts maam]

Thanks Silvr. Good PR prior to an approval announcement.

[silvr_surfr]

Hey JTFM. Looks like the female testosterone PR campaign is in full swing behind Kate Winslet. If you just do a google search you will see many hits from US publications, but also India and UK (could be others).

Kate Winslet PR

I think this is a bullish sign that we will get an announcement soon. Global reach would suggest a global partner.

[Jp2011]

Thank you very much.

[Just the facts maam]

Jp2011, in ANIP's Q3 2023 earnings press release they stated that two 505(b)(2) NDAs were submitted to the FDA. They never provided any details on what the drugs were or for what indications.

Company’s strong R&D organization delivered five new product launches and filed three new ANDAs and two new 505(b)(2) applications in the quarter; retained number two ranking in Competitive Generic Therapy (CGT) approvals

When looking at their 10 Q filing for that quarter under Other Operating Expenses they showed the following:

For the three months ended September 30, 2023, other operating expenses increased to $65.8 million from $55.9 million for the same period in 2022, an increase of $9.9 million, or 17.6%, primarily as a result of the following factors:

• Research and development expenses increased from $7.7 million to $11.1 million, an increase of $3.5 million or 45.2%, primarily due to expenses
related to a 505(b)(2) filing for one product of approximately $1.6 million, and a higher level of activity associated with ongoing and new projects in the three months ended September 30, 2023.

Process of elimination points to the second NDA being filed by ANIP but paid for by another party, most likely their undisclosed partner.

The NDA they paid for is for Tezruly approved July 29, 2024 for ANIP has yet to announce.

I believe the partnered NDA relates to Libigel (female testosterone) as on October 27, 2021 they filed a Certification request to delay submitting results for the large 3,656 participant. Certifications are used when an NDA has been or will be submitted. The partner likely paid for this submission. Had ANIP paid the fee, it would disclose that ANIP paid the larger $3.2 million submission fee associated with the FDA reviewing clinical trial vs the $1.6 million fee where clinical trial data is not reviewed. This would confirm that ANIP had filed an NDA for Libigel, the first FDA approved testosterone drug for women. A blockbuster drug just by replacing off label and compounded testosterone already being prescribed.

The reason I say a decision is due within the two weeks, assumes that there was no problems with the filing and the FDA is meeting its review target timeline. The PDUFA date was not provided for Tezruly, and it was not provided for the partnered drug. Which is indicative of ANIP being bought out or the partner taking an equity stake in ANIP upon approval or shortly afterwards.

JMHO

[Jp2011]

JTFM, I cannot find the NDA you are referring to. Can you please show me where to find it? Also, how do we know there is a partner for this? And do we have any concrete indication for what it is for? Thank you

[Just the facts maam]

Two weeks or less to the FDA decision on the partnered NDA, assuming there were no delays.

I think naked shorts are exiting and the short interest remaining will mostly be tied to the Convertible note offering and those playing both sides of the paint. Those with the notes obviously shorted the stock to minimize their outlay for the offering. It should be equal to the number of shares they expect to get from the conversion.

[Just the facts maam]

Thanks Silvr, so it looks like the ALIM acquisition fits into both AbbVie's and Merck's expansion plans.

[silvr_surfr]

Thanks JTFM. Abbvie is doing a deal with Ripple Therapeutics for implantable drugs for the eye. Hmm, where have we heard that before? More evidence of a potential buyout by them.

Ripple Therapeutics

[Just the facts maam]

Looks like Guggenheim got off the sidelines and raised ANIP price target to $83 from $77 (issued April 23, 2024).

Updated rating

[bagel123]

we will be lucky to finish up for the day knowing ANIP. $+8.5 premarket. we could be bought out at $90 and we would still go down. HC & Truist suck as well. Such a shame this stock seems sooo undervalued and just won't go up!!!!!

[Just the facts maam]

Thanks auh2oman, with BS estimates like Truist's L. Sulewski, you can see why he only rates one star, which may be overrated, in my opinion.

Marketbeat Ratings

[auh2oman]

Going to be an Interesting Day ...

Here's a report released this morning that reiterates the $ 94 price target from H.C. Wainwright:
In a report released today, Oren Livnat from H.C. Wainwright reiterated a Buy rating on ANI Pharmaceuticals (ANIP – Research Report), with a price target of $94.00.

Oren Livnat has given his Buy rating due to a combination of factors including the recent acquisition of Alimera Sciences by ANI Pharmaceuticals, which is expected to be immediately accretive to the company. The acquisition enhances ANI’s rare disease portfolio with a global ophthalmology franchise that should leverage ANI’s existing commercial infrastructure. Moreover, the acquisition of Alimera introduces two long-duration steroid intravitreal implants that are projected to contribute significantly to ANI’s revenue, with pro forma sales estimated around $105 million for the year 2024. Additionally, the expected adjusted EBITDA accretion from the acquisition, including cost synergies, further supports the optimistic outlook on the stock.
Moreover, the report indicates that ANI has continued to see momentum in its Cortrophin Gel product, with a record number of new patient starts, which adds confidence to the projected revenues for 2024 being conservative. ANI’s restructuring of its capital, which includes a new term loan with more favorable interest rates and the retirement of its higher-cost debt, suggests a more efficient capital structure post-acquisition. Despite a warning letter issued to Alimera’s third-party manufacturer by the FDA, Livnat expresses confidence in ANI’s ability to address the manufacturing issues, citing ANI’s stellar track record and core competency in manufacturing. This, in conjunction with the expected guidance update from the consolidated company, reinforces the Buy rating and the $94 target price.

https://www.tipranks.com/news/blurbs/ani-pharmaceuticals-acquisition-of-alimera-sciences-bolsters-buy-rating-and-94-target-price?utm_source=edition.cnn.com&utm_medium=referral

[Just the facts maam]

ANIP trading at between $64.32 and $65.49 premarket on very few shares, but is reflective of ANIP's current market cap + ALIM's market cap prior to merger announcement. Hopefully the start of the climb back to reasonable valuations.

[Roddy4]

Another orribile day! Something is wrong with this stock..

[Just the facts maam]

ANIP will update guidance with Q3 results. Should be Q3 estimates with record number of new patient starts for Corti.

[SparklingDruid26]

https://finance.yahoo.com/news/ani-pharmaceuticals-inc-completes-acquisition-125300287.html

[Easka]

Btw Nice finish at the bell...up over $1.00 in the last 15 minutes, thanks to some big buys!

[Easka]

JTFM, couldn’t agree more, my first thought when I read about their downgrade…This doesn’t smell right! Maybe they should change the name of their firm to; Truist to Themselves?

[Just the facts maam]

After Hours trading has moved back to normal levels with less than 3500 shares at the time of this post. We have seen in excess of 50,000 shares daily for several weeks. Hopefully the games are over and PPS can start an uninterrupted climb.

[Just the facts maam]

I find Truist's motive suspect, as their last estimate of $80 was issued March 1st, 2024. No updates since then until the recent downgrade. Whereas, H.C. Wainwright raised it to more times based on news coming out and now has a $94 price target. It is almost like they are in cahoots with hedge funds intentionally trying to depress ANIP PPS.

Analyst Ratings

[silvr_surfr]

Wow, that is incredible. I have been waiting to see what it was. Now we know why we have had a week-long drop. No idea where these shares come from in such a short time. Didn't they open the door with the convertible notes? We had the lowest short shares before all of this. Good idea for the dividend.

[Just the facts maam]

Short interest as of August 30th, was 2.42 million shares. Where the hell are the shares coming from? If ANIP ever disclosed everything they have on deck, the short squeeze would be historical.

ANIP could easily screw all shorts by announcing that part of the interest savings from the Sr Convertible Note offering will be used to start issuing dividends.

[silvr_surfr]

I was thinking the same thing. That is quite the haircut, particularly based on speculation only. Makes you wonder if they have not been playing for the other side to take advantage of the situation. I sure hope they did not botch the due diligence (was there even a site visit of the old and new Eyepoint manufacturing sites?). We are owed an answer for what happened so we can trust the merger will achieve its targets. We should not have to wait until the next conference call.

[Just the facts maam]

Silvr, auh2oman, part of me feels that Truist is being disingenuous. An authentic analyst would know that Tezruly has been approved and that it is patent protected until 2041. ANIP management had meetings with Truist in June and we still do not know what these meeting were about.

If they are genuine and the deal is back on, they should up the price target to at least $75. $60 was excessive, and questionable at best. Failure to so, makes their analysis suspect.

JMHO

[Just the facts maam]

Thanks Silvr

[Just the facts maam]

Thanks Brusselsspirit.

[silvr_surfr]

Well, some good news is the the judge in the CGON patent litigation approved the "ORDER FOR THE PRODUCTION AND EXCHANGE OF CONFIDENTIAL AND HIGHLY CONFIDENTIAL INFORMATION".

[silvr_surfr]

Thanks auh2oman. If they lost the confidence from their buddies at Truist, this is horrible. Gonna be another bad day.

[auh2oman]

ANI Pharmaceuticals downgraded to Hold from Buy at Truist ...

Let's see if the following in warranted in a couple of weeks:

Truist analyst Les Sulewski downgraded ANI Pharmaceuticals (ANIP) to Hold from Buy with a price target of $60, down from $80. Closure delays of the Alimera Sciences (ALIM) acquisition imply potential post due diligence issues, likely on manufacturing deficiencies of Yutiq, the analyst tells investors in a research note. The firm now sees increased execution risk if and when the deal closes and questions whether the $381M price tag justifies its initial peak sales forecast of $220M by 2030. Truist removed Alimera from its model and plans to “reassess at an appropriate time.”

https://www.tipranks.com/news/the-fly/ani-pharmaceuticals-downgraded-to-hold-from-buy-at-truist

[Brusselsspirit]

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.

[Just the facts maam]

Must be linked to the Eyepoint FDA warning letter regarding Yutiq. The manufacturing agreement is until 2025 and renews every two years, until such a time as Alimera start manufacturing it. I bet ANIP eventually brings manufacturing in house.

[auh2oman]

ANI Pharmaceuticals Provides Update on Closing of Acquisition of Alimera Sciences

09/10/2024
PDF Version
PRINCETON, N.J., Sept. 10, 2024 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (“ANI” or “the Company”) (Nasdaq: ANIP) today provided an update on the status of the completion of its previously announced acquisition of Alimera Sciences, Inc. (“Alimera”) (Nasdaq: ALIM).

We note the Alimera press release issued today. The Company continues to work in good faith toward closing of the acquisition. Any delay is a result of discussions regarding closing conditions, which the Company expects to resolve promptly.

https://investor.anipharmaceuticals.com/news-releases/news-release-details/ani-pharmaceuticals-provides-update-closing-acquisition-alimera

[Roddy4]

Hard to find an explanation. Unless there was a something bigger behind that we don’t know. If not it is just missmanagement

[Jp2011]

They are all such schmucks. Now even if this thing does close, everyone will think it’s a bad investment. It’s unbelievable. They sure do know how to do. One thing. Drive the share price down. I think that’s the only thing they’re good at.

[auh2oman]

Alimera Sciences Takes Legal Action Against ANI Pharmaceuticals to Enforce Merger Agreement

Alimera Has Filed Lawsuit in the Delaware Court of Chancery to Compel ANI to Close Merger Transaction and Honor its Contractual Obligations

Alimera Shareholders Approved Merger Agreement on September 4, Clearing Last Requirement for Closing

September 10, 2024 09:00 AM Eastern Daylight Time
ATLANTA--(BUSINESS WIRE)--Alimera Sciences, Inc. (Nasdaq: ALIM) (“Alimera”), a global pharmaceutical company whose mission is to be invaluable to patients, physicians and partners concerned with retinal health and maintaining better vision longer, today announced that it has filed a lawsuit in the Delaware Court of Chancery (the “Court”) to compel ANI Pharmaceuticals, Inc. (Nasdaq: ANIP) (“ANI”) to fulfill its contractual obligation to close the transaction contemplated by the companies’ previously announced Agreement and Plan of Merger dated June 21, 2024 (the “Merger Agreement”), following Alimera shareholders’ approval of the transaction on September 4, 2024.

Alimera issued the following statement:

“Alimera has fulfilled all its requirements to close the Merger Agreement, yet ANI has failed to adhere to its obligation to close on time. We believe the merger offers compelling value for our shareholders and remain focused on completing the transaction. Accordingly, we are committed to taking all actions necessary to ensure that happens. We are confident we will prevail in the Delaware Court of Chancery and look forward to consummating the merger of our companies.”

Specifically, Alimera’s lawsuit asks the Court to require ANI to comply with its obligations to complete the transaction as contemplated by the Merger Agreement.

https://www.businesswire.com/news/home/20240909143534/en/Alimera-Sciences-Takes-Legal-Action-Against-ANI-Pharmaceuticals-to-Enforce-Merger-Agreement

[silvr_surfr]

Agreed. So strange, we trade one half million shares yesterday and then today it is behaving as if it is halted, but it is not shown as halted on NASDAQ.

[Brusselsspirit]

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

[Brusselsspirit]

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

Thanks

[silvr_surfr]

Well, there we have it. The merger has not closed and now Alimera Sciences is suing ANIP to close it. Maybe there is more going on than a leaky roof.

This explains the T12 halt yesterday. NASDAQ was asking what was going on with the closing.

[silvr_surfr]

Finally got some news on the CGON motion to dismiss. The judge just issued a notice that the matter is under advisement. I looked this up and it means that it is a complex case that requires more time and input to address. I understand he has 90 days to respond. Yikes, more waiting.

[Roddy4]

Yes , but the share performance has been negative over the last 12 months despite good business results. I am just wondering if there is something hidden that we are not able to evaluate.

[Just the facts maam]

Silvr, you may be right about the naked shorts. One reason someone might buy Alim stock is to get the CVRs cheaply. They know the vote has been approved so there is no risk of the PPS dropping below their entry.

[Just the facts maam]

Roddy, there are a lot of hedge funds that shorted the stock when the offering came out. Playing both sided of the paint. I figure they drove price down to reacquire the shorted stock at a cheaper price. If this is the case, they expect PPS to rise
Just a possibility.

[silvr_surfr]

Yep, and I still don't see any news of a halt on ALIM stock. Wow, another 500K ANIP shares traded today. Where do they find these shares (dark pools?). Someone is getting a good deal.

I wonder if ALIM is one of those beaten down stocks with lots of naked shorts. Maybe they are having a hard time closing it because of this. There were 1.6M shares traded today (more than 2x average volume) on a stock that was supposed to be closed. Why would someone buy a stock that would not appreciate?

[Roddy4]

…..and the share continue to go down! May be there is something negative that we don’t know?

[silvr_surfr]

Not fun