ANI Pharmaceuticals Inc (ANIP) News

Uggh, horrible week behind a great quarter. This too shall soon pass.

Here's a possibility for next week's Jefferies London conference. I own Sangamo. They purchased Ceregene's assets many years ago and have two late stage gene therapy products. One is for Hemophilia A and is partnered with Pfizer. The other is for Fabry Disease. They just got a very favorable ruling from the FDA which eliminates the need for further trials and cuts three years off the development timeline. Turns out they will also be presenting in London.. Fabry Disease is a a rare nephrology disease. The product is not partnered and there is discussion about whether it will be licensed out or commercialized by the company itself. They don't have the rare disease infrastructure to pull this off, but we do.

True to course, nothing will probably happen next week.

From what I have been reading, picking RFK Jr may have caused many of the pharma stocks to drop today.

Actually is another nightmare day … roughly - 5% compared yesterday.

Disregard, it looks like a glitch in the system at SA, the volume and previous close were out of synch as well. Oh well!

If you look at Seeking Alpha now you won't see that trade. but this is what I saw



More manipulation.

Seeking Alpha shows that ANIP traded as high as $97.92 today.

I can't tell from what exchange it occurred, if accurate, the partnered drug may have gotten the nod from the FDA. Word should filter out soon enough.

When mapped out on the chart, it was easy to time the institutional manipulation to certain events. Shouldn't be much longer before the trend reverses.

Great chart JTFM. It fully captures my current state of mind on the stock, Looking for the wind to change.

Institutions now own 109.14% of the float. This does not include us retail investors.

PPS has to remain above $96 for the notes to convert prior to 2029. Or , a certain event(s) where they are made whole.

Should be a good ride over the next year.

Maybe recently North, but with all due respect the link to the chart I have attached comparing ANIP to the iShares US Pharmaceutical ETF and Invesco Pharmaceuticals EFT shows the institutional manipulation related to ANIP's actions.


ANIP 1-year return comparison

You can see that in February when ANIP announced good earnings and overcoming the concerns of a significant drop from earlier quarters, as ANIP was not expected to pick up the gains from filling as many drug shortage request, the stock jumped upwards and remained there almost doubling the return of the two ETFs, until May.

After ANIP beat market earning estimates for Q1 in May, ANIP presented at conferences, shortly after the PPS drove down showing lower returns than the other two ETFs once the institutions had complete their accumulation the PPS started to rise and the returns had climbed above the two ETF and likely would of continued but June 24th, ANIP announced the acquisition of Alimera which brought ANIPs return in line with the ETF's. In August on the heals of another good earning and raised guidance, ANIP had big drop which has kept ANIP's return over the last year at about half of the two ETFs. I attribute this to the Senior Note Offering and Capped Call which were announced the following day.

Now if ANIP wanted to show a 1 yr return at a level significantly above the two ETFs, they could show their cards regarding NDAs and patents, naming their partner or provide revenue projections for 2025 and 2026, instead of the vague references to growth parsed out, that we have to analyze and guess to get an idea of their potential. Until then, it is easy for the institutions to keep manipulating PPS downward. The reverse will occur one day and we should benefit from he ride up.

JMHO

The market is jumping up or falling down in terms of individual company share prices over the last 3-6 months. Nothing in our portfolio has stayed a constant course up or down in share price. Huge volatility lately attributed to election results, hurricanes, fires, Federal Reserve, interest rates, company earnings etc. Even NVDA is waffling like the rest, pending earnings and more news re AI developments next week. ANIP is not different in unpredictable daily share price.

It makes sense. But why investors are not buying a stock that is over delivering , growing nicely sales and profit , and rising guidance ? Manipulation is stronger than everything else !!!???

It makes sense. But why investors are not buying a stock that is over delivering , growing nicely sales and profit , and rising guidance ? Manipulation is stronger than everything else !!!???

I figure it is the effect of the Senior Notes holders and the Cap calls being in play.

Sone note holder shorted the stock and took the cash to minimize their out of pocket expense for the loan, knowing they will be able to convert the notes to cover their short position. While institutions covering the cap call are incentivized to keep PPS down. We appear to be in limbo until the next big move. If ANIP is getting a partner to take an equity stake in it, the lower price benefits the partner.

JMHO

Yes , share price really frustrating. No matter what business results they post price goes up for 2 day and then drop back . To me this is a weird , but there must be a reason and soon or later we will find out

Well, for sure they will be visiting the Alimera facility just outside of London. I hope it is somehow connected to a major pharmaceutical deal. The share price action has been frustrating. It was about to break out of its long downward channel, but then, sure enough, it gets brought right back down. With price targets of above $80 and strong Q3 results, perhaps there is an ulterior motive to keep the price where it is.

GLTA

Maybe just a coincidence but Astrazeneca presents at Jefferies in London on the 20th as well, The they are scheduled to present is not available.

I figure any phase 3 deal would be after the readout, but before an NDA submission. Unless, as you said the, cash will be flowing freely. I expect they will have both a partner and serious cash flow.

Another thought, it is "risk on" to even consider taking on a phase 3 product. Maybe they are so bullish since they will have either a partner or lots of cash flow to work with from the new products. Again, he made special emphasis about this.

Yes, that is what I was thinking too. He stopped the interviewer on the call to talk about their M&A ambitions. My first reaction was with what money, but this would be great. Of course a dividend would not be so bad either since they took our CVR away.


GLTA, who knows where this mystery novel ends. I agree with JTFM, the next chapter finishes at the London conference.

It would explain why they are already talking additional acquisition(s).

Makes sense. Wouldn't this also free up considerable cash for another Alimera-scale acquisition?

If they are not getting sold, ANIP still has one seat on the BOD sitting vacant. The partnered NDA could end up with them taking a position on ANIP's BOD, assuming the drug gets approved. The BOD seat would likely include a sizable equity position, possibly triggering the conversion of the notes and capped call freeing up shares for distribution. If we don't see any announcements into the Jeffries conference in London, I believe it remains under raps until January leading into the J P Morgan conference. Theoretically, they could have Tezruly and the other two NDAs approved by then.

Thank you JTFM. I think Nikhil did a good job on the call. A bit long winded on one of the questions. Poor Steve, I don't think he said anything. I have to admit, I was hoping for some "innovation" news ahead of the innovation conference, but no such luck. He made a point of talking about their M&A interests. Not from a merger standpoint, but something like another Alimera Sciences or, as you say, someone with a phase 3 product. If they prevail in the CG Oncology suit, this would certainly provide the needed cash.

I don't think this gives us any more clues about other transactions they may be involved in. I think the website has been updated to include the Princeton location as the Commercial Headquarters, but we have still not seen any communication about what it is for. Further, the last company presentation was done in June and normally they would update these for any conference. Lastly, no word about Tezruly, but, as you pointed out, maybe it is now active again.

ANIP picked up another patent for Corti titled Kits For Preparing And Delivering Purified Corticotropin

Abstract
A sterile preparation of purified corticotropin and methods relating thereto in which the preparation includes corticotropin extracted from a whole porcine pituitary gland including both anterior and posterior portions, and having proteins or peptides having a molecular weight higher than 4.6 kDa removed. Methods of manufacturing, testing, increasing stability, storage, and use of the purified corticotropin are also provided.

Expires September 27, 2043.

Published November 5, 2024.

Take aways from today's conference:
_ Lalwani finally indicated that he saw the ceiling for Acth therapy, as much higher than the previous high of $1.2 billion. Targeting patients resistant to steroids. That Corti has IP protection to 2042 and 2043.

Iluvien and Yutiq have patent protection to 2027 and 2028. but there is high barrier to entry requiring competition to show proof pf concept trials all the way through phase three trials with 3 years of data per participant followed by analysis and finally regulatory submission.

In acquiring Alimera, the benefits of New day and synchronicity trials leading to additional sales was not factored into the deal.

The be looking for similar deals, like Alimera to compliment the many indications for Cortrophin. Maybe even late stage phase 3 deals. (This could explain the hiring of two in-house lawyers an Associate General Counsel–Litigation & Employment plus a Corporate Transactional Attorney.)

As different as night and day.

If ANIP could only be as open about their pipeline!

Compare the 10Q statements on the CG0070 lawsuit:

CGON
On March 4, 2024, a complaint was filed against us in the Superior Court of the State of Delaware by ANI Pharmaceuticals, Inc. seeking a
declaratory judgment that an assignment and technology transfer agreement between us and ANI, dated November 15, 2010, obligates us to pay ANI a
royalty on certain "net sales" of cretostimogene. We dispute the allegations raised in the case and are vigorously defending the matter.

ANIP
On March 4, 2024, ANI commenced a civil action against CG Oncology, Inc. f/k/a Cold Genesys, Inc. (“CG Oncology”) in the Superior Court of the
State of Delaware (“Delaware Action”). ANI’s complaint alleges that, under an Assignment and Technology Transfer Agreement dated as of
November 15, 2010 (the “November 2010 Agreement”), CG Oncology is liable to pay ANI a running royalty of 5% of the worldwide net sales of
cretostimogene made by CG Oncology or any affiliate or sublicensee thereof; and that in February 2024, CG Oncology wrongfully repudiated its
royalty obligation to ANI. On April 2, 2024, CG Oncology filed an answer and counterclaim (the “CGON Answer and Counterclaim”) and
concurrently moved for judgment on the pleadings or, in the alternative, for partial summary judgment (the “Motion for Summary Judgment”). CG
Oncology’s Motion for Summary Judgment seeks judgment declaring that the November 2010 Agreement does not “oblige CGON to pay royalties
after expiration of the latest-running assigned patent.
” CG Oncology also seeks judgment awarding compensatory damages and punitive damages on
counterclaims for alleged breach of the November 2010 Agreement and for alleged misappropriation of trade secrets under federal and Delaware state
law. On April 22 and 25, 2024, ANI filed its reply to CG Oncology’s counterclaims, denying any liability to CG Oncology and asserting additional
counterclaims against CG Oncology (“Reply Counterclaims”) for alleged breach of the November 2010 Agreement and, in the alternative, for unjust
enrichment. ANI’s Reply Counterclaims seek judgment (i) declaring that, under Section 3.3 of the November 2010 Agreement, CG Oncology is
contractually obligated to pay ANI 5% of the worldwide net sales of cretostimogene made by CG Oncology or any affiliate or sublicensee thereof; (ii)
dismissing CG Oncology’s counterclaims with prejudice; (iii) awarding ANI compensatory damages as provided by law, including damages grounded
in restitution and unjust enrichment; (iv) in the event of a judgment in ANI’s favor on ANI’s fourth counterclaim for unjust enrichment, ordering CG
Oncology to re-transfer to ANI ownership of all assets that ANI sold to CG Oncology under the November 2010 Agreement, including, without
limitation, all data and documentation comprising IND 12154; and (v) in the event of a judgment in ANI’s favor on ANI’s fourth counterclaim for
unjust enrichment, imposing a constructive trust on all fruits of CG0070-related assets that ANI sold to CG Oncology under the November 2010
Agreement including, without limitation, all data and documentation comprising IND 12154 and any other IND that CG Oncology may have for
CG0070. On May 15, 2024, CG Oncology filed a reply to ANI’s counterclaims, which generally maintains the positions in the CGON Answer and
Counterclaim. The parties are currently engaged in pretrial discovery. On August 22, 2024, the court heard the parties' oral arguments in a hearing on
CG Oncology’s Motion for Summary Judgment. The court's decision on the Motion for Summary Judgement is pending. ANI intends to vigorously
pursue this matter.

Just imagine if the CG0070 assets are returned to us.

Thanks JTFM. What a strange series of events.

Looks like Tezruly is no longer listed as discontinued in the Orange Book. It was always listed on ANIP products section. Prescribing info is not available at this moment.

Maybe it gets announced this week.

Tezruly

I guesss they are not worried about making their bonus.

Thanks JTFM. They always say follow the money so this is a big motivator for 2025. I have to admit, I don't understand the terms of the PSU. On one hand it says that the payout is capped at target if they have negative stock performance. Then, there is a range of 50% to 200% of target. It does not seem like they can ever be below 100% of target.

I looked at the performance of the S&P 600 index since 1/2023. It is essentially flat. Our share price has grown by 50% since then. Given the above, I am not sure how this translates to an award. Assuming no change in the index in 2025, I guess they have another 50% to go in the share price to get 200%. Of course, the index will likely grow, so I hope they aim higher.

Another reason for a big announcement from ANIP.

50% of ANIP's executive bonuses are tied to Total Shareholder Return. all the info they have withheld, keeps PPS low, and puts their bonuses at risk. They have until the end of 2025 to catch up to their peers. What is the incentive to sit back and place their bonuses at risk.

The following is from their 2023 proxy statement:

2023 Equity Awards

For 2023, we included performance metrics in our long-term incentive plan, the Compensation Committee approved target long-term equity incentives using a mix of 25% performance-based restricted stock units (“PSUs”) and 75% time-based restricted stock awards (“RSA”) for all of the NEOs. RSAs vest annually over 4 years.
50% of the PSUs are based on performance against our three-year Adjusted EBITDA Year-on-Year Growth Rate, and the remaining 50% are based on our three-year relative Total Shareholder Return (“TSR”) against the constituents of the S&P 600 Pharmaceuticals, Biotechnology and Life Sciences Index. Performance will be measured from January 1, 2023 to December 31, 2025, and the PSUs will cliff vest following the end of the performance period upon the Compensation Committee’s certification of actual results. The PSUs have a threshold payout of 50% of target and a maximum payout of 200% of target, and the payout for the relative TSR PSUs will be capped at target if our stock price performance is negative over the performance period.


ANIP's 2023 proxy statement

Thanks for the correction Silvr.

Oops, meant to say thank you North.

North gets credit for that one.

Thanks Silvr, a lot of outlets are indicating Small Cap benefit from both a Trump economy and the Fed rate cuts. Should get interesting.

No mention of ANIP, but see WSJ article discussing small cap M/A activity extending into 2024. Online over the weekend, likely print edition today

Must be getting closer to a big reveal. Even NBC news is now covering female testosterone.

More women seek testosterone therapy, prompted by influencers, doctors say

Thanks Silvr

Here's some more AI info on DME:

Recent trends in diabetic macular edema (DME) include:
Increased prevalence
From 2009 to 2018, the annual prevalence of patients with DME increased from 0.7% to 2.6%.

Increased use of anti-VEGF injections
The annual prevalence of anti-VEGF injections increased among patients with DME from 15.7% to 35.2%.

I would suspect that the trend is growing because of the baby boomers. I am more bullish on the Alimera acquisition now since we have demographics and, hopefully, superior technology, in our favor.

Thanks for the info Silvr. FYI, the CC transcript is now available on Seeking Alpha.

I agree JTFM. No mention of Tezruly or the Princeton site in their 10Q. The only explanation for this has to be that they are under a non-disclosure agreement. Also, no corporate presentation since June. Well, maybe we learn more ahead of the upcoming conferences.

I got added into the conference call about ten minutes late. They were talking about the "New Day" clinical trial. If I heard it right, the study compares the use of Iluvien against the current standard of treatment (anti-VEGF injections) for diabetic macular edema (we need to learn a whole new vocabulary). It looks like the market for anti-VEGF injections is in the billions. It's a big deal if we can then surpass the standard of care. One more potential large growth catalyst to add to our pipeline and something a suitor(s) would be interested in. Hey, maybe a deal here is dependent on the trial outcome.

AI is cool, here is a write up it did on the trial:

The NEW DAY clinical trial was a randomized, controlled, multi-center study that evaluated the fluocinolone acetonide intravitreal implant (ILUVIEN) as a treatment for diabetic macular edema (DME). The study's goals were to:
Demonstrate that ILUVIEN can reduce retinal damage and treatment frequency

Show that ILUVIEN can be a better baseline therapy than the current standard of care, which is repeat anti-VEGF injections

Provide data that could lead to a change in the current paradigm of DME treatment

The study enrolled approximately 300 patients in about 42 sites across the United States. Patients were randomized to receive either ILUVIEN or a loading dose of anti-VEGF injections. After the initial 16 weeks, both groups received supplemental anti-VEGF injections as needed. The primary outcome measure was the average number of supplemental injections needed during the 18-month treatment period.

Alimera Sciences, Inc. announced that it had completed enrollment for the NEW DAY study in May 2023. The company expects to share data from the study in early 2025

If ANIP is not being bought out, they must be merging with another company. No mention of Tezruly approval even though Lalwani touted the NDAs as being a big reason for acquiring Novitium. Either the analysts were told not to ask about or they are not very good analysts.

Hard for them to argue it is not a meaningful and reportable event after touting it in a number of corporate presentations.


JMHO

Nice day, now let's have this continue north next week. great weekend to all

Numbers are good but once gain market reaction is not positive so far …. I don’t know why to think.

Numbers are good but once gain market reaction is not positive so far …. I don’t know why to think.

Unable to listen to call, but numbers look good. I'm I correct in my optimism?

https://finance.yahoo.com/news/ani-pharmaceuticals-reports-record-third-115000820.html

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