ANI Pharmaceuticals Inc (ANIP) Options

Bulk Manufacturer of Controlled Substances Application: ANI Pharmaceuticals, Inc. ...

https://www.federalregister.gov/documents/2024/05/31/2024-11879/bulk-manufacturer-of-controlled-substances-application-ani-pharmaceuticals-inc

Thanks auh2oman. I like that Psilocybin (7437) will be imported for use in dosage form development leading to use in clinical trials. which was in previous applications.

Importer of Controlled Substances Application: ANI Pharmaceuticals Inc. ...

ANI has submitted another application:

https://www.federalregister.gov/documents/2024/05/30/2024-11794/importer-of-controlled-substances-application-ani-pharmaceuticals-inc

I would like to wish everyone a happy and healthy Memorial day, along with my thanks for those of us who served our country. God Bless you all 😀

Feels like the old days, great earnings and down ,down, down we go, 🤣. Just gotta love the MM boys

Nice find JT, thanks

Thanks JTFM. I saw that previously, but never connected the dots to a Libigel approval. What a seal of approval if an FDA-approved study is ultimately used to approve our product. Also may speak to the complexity of presenting the data to FDA which is why it is taking so long.

I find it interesting that in 2016 the FDA funded the following in 2016.

Cardiovascular Risk of Testosterone Treatment in Women (Special Funding) - Lai-Ming Lee, PhD/CDER

A variety of testosterone products are used off-label for the treatment of female sexual dysfunction (FSD). Due to the chronic nature of FSD, these products are anticipated to be used as long-term therapy in women. Therefore, assessment of cardiovascular risk will be an important factor in the risk/benefit determination. The Framingham General Cardiovascular Risk Score predicts the 10-year risk of all cardiovascular events including coronary heart disease, stroke, transient ischemic attacks, and heart failure. The variables used in the formula are age, sex, systolic blood pressure, total cholesterol, high-density lipoprotein, use of hypertension medication, smoking status, and history of diabetes. We hypothesize that the Framingham General Cardiovascular Risk Score will be useful in estimating cardiovascular risk of drug products in Phase 3 trials. We will use available data to determine the utility of the Framingham General Risk Score to estimate the cardiovascular risk in women exposed to drug products with a likelihood of a cardiovascular signal. If successful, this formula would be applied to androgens and androgen-like products being evaluated for the treatment of female sexual dysfunctions in women.

I would not surprised if this forms part of the post marketing surveillance is part of Libigel or whatever it will be called. I would be highly surprised that the Libigel trial did not collect the 10 years of safety data, even if they stopped using the drug in 2012 or 2016. The 10-year post marketing surveillance will collect real world safety data for a total of 10 years.

FDA Office of Women's Health Research Program Awards by Funding Year

That is interesting. Thanks Silvr.

Here's a new researched benefit for testosterone for women:

Testosterone and Brain Volume

Thank you JTFM. I like the idea of nearly doubling the earnings per share for the each of the next two years.

Fintel shows two analyst estimating ANIP's average EPS of $8.25 in 2025 and $15.20 in 2026.

I wonder what event(s) they are seeing, it is unlikely to related to CG Oncology. The following are Fintel's Analyst Estimates

Date EPS Average (Quarterly) Number of Analysts (Quarterly) EPS Average (Annual) Number of Analysts (Annually)
2031-12-31 -- -- 7.57 3
2030-12-31 -- -- 10.32 3
2029-12-31 -- -- 9.62 3
2028-12-31 -- -- 9.23 3
2027-12-31 -- -- 6.87 4
2026-12-31 -- -- 15.20 2
2025-12-31 1.16 3 8.25 2
2025-09-30 1.13 3 -- --
2025-06-30 1.22 3 -- --
2025-03-31 1.10 3 --
2024-12-31 0.98 3 4.56 6
2024-09-30 1.03 3 -- --
2024-06-30 1.07 3 -- --

Fintel

Thanks auh2oman

ANI News ...

ANI Pharmaceuticals price target raised by $4 at H.C. Wainwright.

https://thefly.com/news.php?symbol=ANIP%2C+&x=44&y=8&market_stories=on&hot_stocks_filter=on&rumors_filter=on&general_news_filter=on&periodicals_filter=on&earnings_filter=on&technical_analysis_filter=on&options_filter=on&syndicates_filter=on&onthefly=on&insight_filter=on&market_mover_filter=on&e_inter_filter=on&mid_wrap_filter=on&sec_wrap_filter=on&analyst_wrap_filter=on&analyst_recommendations=on&upgrade_filter=on&downgrade_filter=on&initiate_filter=on&no_change_filter=on&events=on

Mallinckrodt reported sales of Acthar as

Q1 2024 $102.8 M vs Q1 2023 $82.0 M

An increase of $20.8 M YoY

ANIP reported an increase of $20.6 million in Corti sales.

Looks like ANIP and Mallinckrodt are splitting the growth in the market 50/50.

Mallinckrodt's Q1 filing

Silvr, I see that CGON stock has dropped significantly $28.50 and putting up daily 52 - week lows. Investors are now questioning their calculation of the complete response rate. Additionally, some are seeing, as you pointed out, the clarity of ANIP's stance vs the vagueness of CGON's stance on the matter.

CGON has much more to lose by their greed than ANIP in this matter. If they lose the ability to file an NDA, their stock becomes almost worthless.

Risk vs Reward make this a very big gamble by CGON for only 5% of net sales.

JMHO

Excellent summary JTFM. I like how transparent and detailed ANIP was in their 10Q about the suit including sharing the agreement un-redacted. This comes from a position of strength. Contrast that with CGON who treats it as a nuisance in their 10Q, which, to me, is a position of weakness.

Normally, I can find links to the suits on the various legal sites (e.g. Pacer), but I am not able to find any links on this one. I would pay to access the documents for this one, if I could find them.

Silvr, having read the agreement, based on case law related to collecting royalties beyond patent coverage, I believe several issues will pop up.

Good for ANIP - they tied compensation to Patents and BioSante Know-how. (patents alone they would be dead in the water.)

Possibly troubling for ANIP- the running royalties does not provide an end date.

Larger issue many drugs get marketed late in patent life. This is a case that could settle the issue for the industry.

I agree that pulling the IND could help.

In the end I see an out of court settlement rather than either side losing in court, especially as CG Oncology gets closer to filing an NDA.

JMHO

Thanks North, hopefully you are right in your assessment.

Silvr, may the minimum 18.7% stake only applied for the first 12 months?

3.6 Subscription Agreement. Contemporaneously with the execution of this Agreement, Cold Genesys shall execute a “Subscription Agreement” in a form substantially similar to that attached hereto as Exhibit II to transfer to BioSante a nineteen and nine tenths percent (19.9%) ownership position in Cold Genesys. BioSante’s ownership position in Cold Genesys shall not be reduced below 18.7% for the first twelve (12) months after execution. If necessary, Cold Genesys shall issue additional shares to BioSante to prevent subsequent dilution as set forth in this Section. Cold Genesys agrees to provide to BioSante financial reports due twenty (20) days after the end of each calendar quarter of a given year in order for BioSante to comply with Securities and Exchange Commission reporting regulations and rules.

Silvr, listening to the Conference Call, I wonder if there was a later agreement regarding dilution or if the non-dilution does not refer t common shares.

Stephen Carey
Yeah, Vamil, good morning, and thanks for taking our call this morning. Yeah, in terms of our equity position in CG Oncology, this is a position that harkens back to the November 15, 2010, transaction where the company sold assets to CG Oncology. And at that time, right, way back in that time, our equity stake was 19.9%. Obviously, during the intervening years, that ownership position has been diluted down and upon CG Oncology's IPO in January of 2024, we hold just shy of 220,000 shares of their common stock, which, as you see, as of March 31th, was worth about $9.7 million.

I think there is an archived transcript of, or a link to, the oral arguments and the judge’s comments with respect to the parties’ positions/motions in this case. Did you see the transcript or hear the arguments?

The judge had an opening in his schedule, and the arguments were held sometime in the past ~10 days. I am sure the losing party will appeal. I hope I am not confusing this case with other cases that our invested companies are involved in, or that I am imagining the judge had some sharp questions regarding CG’s position with respect to paragraphs of the contract.

Occasionally, I will get technical on the charts. Today's candle looks like a hammer which could bode well then for next week.

Couldn't agree more. We are certainly some of those investors. However, I always look at the original Cell Genesys employees and investors. What a legacy they created, but never profited from. Now, CG Oncology is looking to "unjustly enrich" themselves to this technology. I love the threat to take away the original IND. Not much they can do without that. I agree, this could be why CGON took a hit today with the publication of our 10Q. All the more reason for them to settle.

Thanks JTFM. They were certainly envisioning a different working relationship then versus now. The board membership and fixed ownership level were proof points. It makes me wonder what happened. Did it just fall by the wayside when Art left? Cold Genesys certainly became a new company. Was this one of the purposes of this to distance themselves from the transfer agreement?

It is good to hear that there are remedies and precedent on our side. Who knows, maybe we will end up with both a larger equity stake (beyond the 200K shares) and a royalty.

It in the institutions hands and we just ride the waves up and down.

Should be trading at new 52 week highs next week as more institutions have time to absorb the info.

Silvr, ANIP could do all a solid for all biotech by taking this all the way. How many early inventors are getting screwed, because it takes so long for drugs to get approved and each the market.

I think the markets are waking up to this fight as CGON has fallen to $28.50.

Thanks Slivr, as I read it it looks like ANIP could own 18.7 % of a $2 billion company. I agree I can see investor led litigation landing on CG Oncology's doorstep.

Regarding them hanging their hat on patent expiration. I found Beyond Hybrid Licenses—Strategies for Post Patent Expiration Payments in the United States very interesting in understanding the possible arguments and case law impacting those arguments.

When looking at the B. Kimble v. Marvel Entertainment, LLC case, if they remain consistent, it appears that, Justices Alito, Thomas and Roberts would likely side with ANIP if it ever got to the supreme court.

Silver, That is exactly what i was thinking walking back into the house after going to TSC, 🤣🤣. How funny is that🤣

Yes, makes zero sense BB. I guess we consider ourselves fortunate that it is not down 10% on earnings day like in the past (well maybe down ~10% from the daily high).

Silvr, Just listened to the call and was going to look it up on the 10Q and you already posted it... Thanks.
I thoughts exactly about GC claims! These lawyers tell the management what they want to hear, "We can get
you even more money for damages etc etc" In the mean time They line their pockets with more and more fees.

Good call overall but Nikhil is just way conservative! I believe they will raise full year guidance on the next call,
he had a hard time to justify to analysts why they didn't raise it now.

Great numbers? pre-market up $ 3.50 - $4.00, now @ -$1.12. What the heck?

I found the CGON update in the 10Q (page 27)

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 and concurrently moved for judgment on the pleadings or, in the alternative, for partial summary judgment. CG Oncology 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 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. ANI intends to vigorously pursue this matter.

Wow, this is going to be a nasty fight. I can't imagine the gall of CGON to seek damages against us while screwing us at the same time.

You called it JTFM. The 10 Q is out and I am not seeing any updates on the CGON litigation. CGON did not provide an update either in their report. What is included in the 10Q is the original transfer agreement with Cold Genesys. I don't see the language you were hoping for to extend the patent term. However, there is some very interesting language around us retaining a 19.99% equity stake in the company regardless. That seems like a bigger deal (I wonder if the investors in the various rounds were made aware of this).

I guess the court will figure it out. It deserves a question on the conference call today, but it will probably not happen.

Record earnings beats estimate on both revenue and eps.
Gross profits over $88 million
$18.2 million in net income (GAAP).

I believe they could of raised guidance. Most likely to be raised in August.

GLTA

Silvr, if it was after hours, I would be more concerned. In the current guidance, Lalwani left lots of room to raise it. Tailwinds only included 1st quarter opportunities. It should allow for an increase. I also expect an increase in Corti guidance which should also add to the upgraded guidance.

Most likely they announce a launch or two as well and the Q10 filing should speak to litigation regarding Cg Oncology.

Hopefully we also hear about a Rare Disease acquisition.

GLTA

GLTA for tomorrow's earnings release. I never like Friday releases. They have two investor conferences later in the month so I would hope they have some positive news to share.

Thanks Silvr

Thanks JTFM. I seem to recall a comment from Nikhil a couple of years ago about them working on a "resin" technology platform. It stuck with me and the active ingredient in this product is used as a cation-exchange resin. In this case, it replaces potassium with sodium. It looks like these resins are also used in controlled release for tablets so maybe that was the basis for the comment.

It does look like there are other medical applications for these resins. It reminds me of Cortrophin Gel where the drug was in use and the research done decades ago. Who knows, maybe we will see Kionex reborn for other indications as well.

Looks like ANIP is going to relaunch Kionex (Sodium Polystyrene Sulfonate) it is a drug obtained from Perrigo but had yet to bring it back to market. ANIP updated the trademark revived the trade mark for Kionex in March.


Drug Shortage

ANIP got approval for manufacturing on May 3rd.

Approval

Trademark

Easka, it appears that the FDA appear to give more time before issuing a pre-notice which informs the company that they have 30 days to submit result or risk facing fines for non- compliance. Companies usually post results shortly after receiving the pre-notice. Technically, the are at risk of facing fines now, but it is unlikely as long as they submit the results upon receiving the pre-notice, or sooner. The FDA shoots for posting pre-notices that were issued every quarter.

Interesting, I wonder if this would get them off the hook for the fines for delaying release of the results?

That's great news JT, thank you

ANIP now has some patent protection for Corti up to October 27, 2043.

Methods for Storing and Warming Purified Corticotropin Compositions

Now that the New Jersey plant expansion is completed, I believe these are the first jobs postings for a second shift at the New Jersey plant, that I have seen. They obviously are ramping up for more volume.

Careers

I generally look at the classic view as well. They are 18 month late for an extension, and no new trial was submitted which would have had to be registered and posted by October 27, 2022. Therefore, I don't believe a extension for good cause qualifies. Really looking like a certification request.

If AbbVie is involved, I believe they are waiting for July 1, 2023 when the Michael A. Roberts officially assumes the helm, as CEO. A good way to start under a new CEO.

Now, they don't have to worry about the Pre-notice for non compliance in submitting results coming out now until the first week of July.

JMHO

Hmm, I look at the classic version of the clinical trials page and it does not have this comment, so I cannot confirm that it is new. I looked at the rules again, and we can say for certainty that it is delayed for one of the below three reasons (perhaps the second reason does not even apply):

Certify Initial Approval: Trial studies an FDA-regulated drug product (including a biological product) or device product that was not approved, licensed or cleared by FDA for any use before the Primary Completion Date of the trial, and the sponsor intends to continue with product development and is either seeking, or may at a future date seek, FDA approval, licensure, or clearance of the drug product (including a biological product) or device product under study.

Certify New Use: Trial studies an FDA-regulated drug product (including a biological product) or device product that previously has been approved, licensed, or cleared, for which the manufacturer is the sponsor of the trial and for which an application or premarket notification seeking approval, licensure, or clearance of the use being studied (which is not included in the labeling of the approved, licensed, or cleared drug, product (including a biologic product) or device product) has been filed or will be filed within one year with FDA.

Extension: Request, for good cause, an extension of the deadline for submitting results information.

Could we FOIA this and find out what the delay reason was?

Silvr, regarding the Libigel trial results, the following may have been on their results page in the past, but I don't remember seeing it.

The sponsor or the investigator has either requested or received a certification to delay submitting the study results.

Libigel Trial Results

Good info, Silvr.

Thanks.

Good report out on CG0070 at today's AUA Annual Meeting.

May 3 Results

It also looks like one of the original Ceregene founders is still looking at using our AAV2 technology to treat Alzheimers, this time with a different payload. Here's the phase 1 clinical trial that is underway. Even if this works, by the time it completes its testing and regulatory approval, I can't imagine we would have any stake remaining.

AAV2-BDNF Clinical Trial