ANI Pharmaceuticals Inc (ANIP) Options

Possibly. It would definitely help in rolling out female testosterone.

Thanks JTFM. Curious, these are products that "Hims & Hers" sells. Check out their recent announcement of their purchase of "Trybe Labs". The article also mentions them purchasing US rx production facilities given the dependence on overseas production (and tariffs). Do we have a supply agreement with them or some other deal in the works?

Hims & Hers

Their website is taking a "pause". Never seen that before, but I guess it has something to do with the acquisition. If you can, check out their novel home testing device to draw blood. I checked and they use LC/MS for their testosterone testing. This home testing and tele heath prescribing seems like a superior and more economical model for a female testosterone product as well to join their current male one.

Novitium picked up an approval for Finasteride and Tadalafil. The original and only other generic have been discontinued. I don't know what the market size is for the drug, but no competition is good.

Approval

I think I have seen this movie before. High volume at a double/triple top ($65/shr) followed by the shorts taking it down. Hope it breaks through the resistance this week.

GLTA

Thanks for doing that JTFM. CGON recently filed a "motion to compel" so they are not letting up. It will be heard on April 2. There is also mention of a RULE 37(E) which sounds like it refers to an electronic record that CGON wants to see that was lost by ANIP. Not sure what these all mean, but we will know soon, and maybe we get a settlement anyways like you suggest..

I sent ANIP IR the info. I would expect their legal team to be aware of it and would be surprised if an out of court settlement is not being worked on.

How timely JTFM. Great find. I sure hope this get read into the CGON suit since it looks like some relevant and important precedent.

Maybe you should send it to investor relations just in case.

Silvr, in December the U.S. Supreme Court (SCOTUS) denied the petition for writ of certiorari filed in Zimmer Biomet Holdings, Inc. v. Insall. I think this heavily favors ANIP in their CGON litigation, as the following shows the importance of Biosante tying the royalties to the tech transfer.

“The SCOTUS denial leaves in place lower rulings finding that the arbitration award was not against public policy because modifications to the licensing agreement separated the royalty provisions from Insall’s patent rights.”

SCOTUS Denies Petition Challenging Post-Patent Expiration Royalty Obligations Upheld in Arbitration

Great news JTFM. Thank you.

Looks like Iluvien is this weeks ANIP news maker. First the label expansion to include an indication for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye (NIU-PS) announced on Friday. And today buying out the the 3.125% perpetual royalty obligation to SWK Funding LLC (SWK) on worldwide net revenues of Yutiq and Iluvien.

ANIP news

This should send a message that ANIP feels confident about its future growth.

Inzirqo's patent protection filed with FDA extends to January 23, 2044.

Inzirqo

Thank you JTFM. This is encouraging. Isn't part of this growth simply due to moving from a 5 ml vial to a 1 ml syringe? Regardless, what matters most is the pricing and I expect there is a premium paid for the self dosing alternative.

Looks like MNK will merge with Endo

Merger

I found Mallinkrodt's Earnings release from Friday promising for ANIP's self prefilled syringe option.

Q4 Acthar Results
Acthar Gel net sales were $138.8 million in the fourth quarter, an increase of 33.0% versus the prior year period, and $485.7 million for the full year, an increase of 14.2%. Growth in the fourth quarter was driven by the successful launch of SelfJect, which accounted for more than 70% of new Acthar Gel prescriptions, as well as prescriber enthusiasm and patient demand. The Company expects Acthar Gel to continue its momentum and grow in the low-single digits in 2025.


vs

Q3 Acthar results

Acthar Gel net sales were $126.4 million in the third quarter, an increase of 3.5% versus the prior year quarter and the third consecutive quarter of year-over-year growth for the brand, reflecting increasing prescriber referrals and patient demand. Additionally, the Company successfully launched SelfJect mid-quarter and has received enthusiastic physician and patient feedback. Given the brand's return to growth and positive momentum, the Company now expects full year 2024 Acthar Gel net sales to grow approximately 10%.

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.

Thanks Silvr

CG Oncology is presenting a late breaking abstract from "our" Phase 3 study in a couple of weeks:

Late Breaking Abstract

Thanks for looking at this. Your points make sense to me. Section 3.3. certainly refers to "BioSante Technology" which is defined in the agreement as "... the BioSante BioMaterials, the BioSante Documentation, BioSante Know-how and the BioSante Patents."

I'm confused by the judge's opinion (or maybe it is Grok's misread since I don't have access to his opinion). He references section 1.1 and the link between "net sales"of "products" and a "valid claim". The version of the agreement I am looking at has the valid claim language only referring to "OVT Products" (i.e. other related products). This would make sense that any other product that is not CG0070 would have to be within our patent scope.

Importantly, the "Net Sales" refers only to "Licensed Products" which then refers to the "BioSante Technology" above. This is more than just the patents.I don't get what the judge is then saying.

According to Articles II and III, it looks like ANIP clearly differentiated the Technology Agreement from the Patent Assignment agreement as articulated in sections 2.1 and 2.2. In section 3.3, it clearly states that the running royalties are tied to an approved therapy derived all or in part from the BioSante Technology. Big gamble on CG Oncology's part to go to trial, a roll of the dice on potential punitive damages. Intent of the deal looks pretty clear.

ARTICLE II
ASSIGNMENT AND TRANSFER OF RIGHTS AND TECHNOLOGY
2.1 Assignment of Intellectual Property Rights and BioSante Technology. Subject to the terms and conditions of this Agreement (including without limitation full payment under Article III), BioSante, on behalf of itself and its Affiliates, hereby sells, assigns and transfers to Cold Genesys all entire right title and interest and to the BioSante Patents and the BioSante Knowhow.

2.2 Patent Assignment Agreement. Contemporaneously with the execution of this Agreement, the Parties shall execute a “Patent Assignment Agreement” in a form substantially similar to that attached hereto as Exhibit I to document the transfer of the BioSante Patents. Cold Genesys shall have sole responsibility, at its sole cost and expense, to file the Patent Assignment Agreement and any forms or documents as required to record the assignment of the BioSante Patents from BioSante to Cold Genesys with the United States Patent & Trademark Office and any applicable foreign equivalents. As of the Effective Date, as between the Parties, Cold Genesys shall be solely responsible for maintaining (including prosecution and payment of all fees) and enforcing the assigned BioSante Patents.

2.3 Transfer of the Ownership of BioSante BioMaterials and BioSante Documentation. In connection with the assignment above in Section 2.1, BioSante shall provide and/or deliver to Cold Genesys:
(a) BioSante BioMaterials. On the Effective Date, BioSante shall transfer the ownership of, at Cold Genesys’s sole cost and expense, the BioSante BioMaterials to a location of Cold Genesys’s choice. As of the Effective Date, as between the Parties, Cold Genesys shall be solely responsible for controlling, maintaining and storing the BioSante BioMaterials at its sole cost and expense. Upon Cold Genesys’s written request, BioSante agrees to temporarily maintain the BioSante BioMaterials at its present location, Pacific BioMaterials Management, Inc. in Fresno, Ca, on behalf of Cold Genesys, and at Cold Genesys’s sole cost and expense, at the current rate of four hundred and seventy five US dollars ($475) per month for up to a period of three (3) months.
(b) BioSante Documentation. On the Effective Date, BioSante shall transfer the ownership of, to Cold Genesys, at Cold Genesys’s sole cost and expense, the BioSante Documentation to a location of Cold Genesys’s choice. As of the Effective Date, as between the Parties, Cold Genesys shall be solely responsible for controlling, maintaining and storing the BioSante Documentation at its sole cost and expense.
(c) BioSante Patents. Within ten (10) business days after the Effective Date, BioSante agrees to provide to Cold Genesys: (a) copies of all of its patent files of the patents and of the pending patent applications constituting BioSante Patents and the names and addresses of counsel who are currently involved in the prosecution thereof, and (b) copies of other relevant documents, if any, in BioSante’s possession that relate to the BioSante Patents, including the prosecution histories constituting the BioSante Patents. Cold Genesys shall be responsible for retaining present patent counsel or transfer of the responsibility for oversight of the patents to another law firm or third party.

2.4 Excluded Assets; No Implied Licenses. Nothing contained in this Agreement shall be construed as conferring (i) any ownership rights to any intellectual property rights, technology or any other assets (whether tangible or intangible) owned or controlled by BioSante other than those expressly transferred under Article II of this Agreement, or (ii) any license rights, by implication, estoppel or otherwise, under any intellectual property rights owned or controlled by BioSante, other than as expressly transferred or granted in Article II of this Agreement.

2.5 Technical Assistance. Except as provided under Sections 2.2 & 2.3, neither Party shall be required to provide the other Party with any technical assistance or to furnish the other Party with, or obtain on their behalf, any documents, materials or other information or BioSante Technology.

2.6 No Assumption of Liabilities. Notwithstanding anything herein to the contrary, neither party shall not assume any liability of the other Party, including, without limitation, any such liability relating to any fact, circumstance, occurrence, condition, act or event or omission occurring prior to the Effective Date.

2.7 Insolvency. Notwithstanding anything herein to the contrary, should Cold Genesys become insolvent or cease to exist as an on-going business entity, within 12 months from the Effective Date of this Agreement, Cold Genesys agrees to assign its entire right, title and interest in any remaining BioSante Technology to BioSante or its successor. Cold Genesys will have the sole right to choose what portions of BioSante Technology need to be maintained or being used during this period and the remaining BioSante Technology will pertain only to those remaining portions in an “as is” condition.

ARTICLE III
COMPENSATION
3.1 Initial Payments. In exchange and consideration for the rights and BioSante Technology transferred hereunder in Sections, 2.1, 2.2 and 2.3, Cold Genesys shall pay BioSante:
(a) a one-time, non-refundable acquisition fee of fifty thousand US dollars ($50,000) (“Acquisition Fee”) upon the
Effective Date; and
(b) a one-time, non-refundable payment to reimburse BioSante for actual fees and costs related to filing, prosecuting or maintaining the BioSante Patents from June 23, 2010, the Effective Date of the MOU, to the Effective Date of this Agreement in the amount of forty thousand six hundred and ninety one dollars and twenty cents ($40,691.20) composed of thirty eight thousand five hundred five ($38,505) in costs and fees plus two thousand one hundred eighty six dollars and twenty cents ($2,186.20) in patent annuities. (“Reimbursement Payment”).

3.2 Sublicensing Fees. Cold Genesys, and its Affiliates, shall pay to BioSante thirty percent (30%) of any Sublicensing Fees received from any Sublicensee should Cold Genesys or its Affiliates license or sell the BioSante Technology to a Third Party prior to completion of a Phase 2 Clinical Trial.

3.3 Running Royalties. Cold Genesys, its Sublicensees and its Affiliates, shall pay to BioSante running royalties in the amount of five percent (5%) on Net Sales of CG0070 in the Territory; and two percent (2%) on Net Sales of other OVT Products for an approved therapy derived all or in part from the BioSante Technology. In the event that other royalties are due after successful development of the BioSante Technology, royalty payments to BioSante shall be adjusted such that total royalty payments for CG0070 five percent (5%) or other OVT Products two percent (2%) not exceed a total of five percent (5%) and two percent (2%), respectively; however, the royalty due to BioSante shall not be reduced to less than 2.5% and 1% respectively.


Exhibit 10.1 of ANIP Q1 2024 10-Q

Thanks Silvr.

Looks like shorts are getting out of dodge. Hopefully we get more follow up tomorrow. I would not be surprised to see large after hours volume. It is already over 2X normal volume.

Sure seems that way. With the long market lead times you would have thought this would have been made more explicit. I did not have access to the judge's opinion on the motion to dismiss, but Grok did.

Silvr, Hard to believe that their lawyers back in the day did not cover Patent expiration of the drug at the time of the agreement.
They certainly dropped the ball IMO.

I asked Grok to weigh in on who's winning our dispute with Cg Oncology. Here is the response (what an age we are living in):

The trial between ANI Pharmaceuticals, Inc. (formerly BioSante Pharmaceuticals, Inc.) and CG Oncology, Inc. (formerly Cold Genesys, Inc.) centers on a dispute over royalty payments tied to an Assignment and Technology Transfer Agreement from November 2010. Since you’ve asked who “appears to be winning” as of March 12, 2025, I’ll base my analysis on the most recent public court documents available—specifically, the Delaware Superior Court’s Memorandum Opinion and Order from November 18, 2024 (C. A. N24C-03-022-SKR CCLD)—and assess the current trajectory without speculating beyond the record.

Background of the Case

Agreement: ANI sold CG its oncolytic virus technology (OVT), including materials and patents for CG0070 (cretostimogene grenadenorepvec), a bladder cancer drug. In return, CG agreed to pay royalties on sales of CG0070 and related products.
Dispute: ANI claims CG owes royalties as CG0070 nears commercialization (post-Phase 3 trials and IPO in 2024). CG argues no royalties are due because the assigned patents expired—or will expire—before revenue is generated, nullifying the obligation under their interpretation of the agreement.
Legal Action: ANI filed suit in Delaware Superior Court in March 2024, alleging breach of contract. CG moved for judgment on the pleadings or summary judgment to dismiss the case.

Latest Ruling (November 18, 2024)

CG’s Motion Denied: The court denied CG Oncology’s motion for judgment on the pleadings or summary judgment. This is the key development as of late 2024.
Reasoning:

Ambiguity in Agreement: The court found the royalty provisions in the 2010 Agreement ambiguous. Section 2.5(a) ties royalties to “Net Sales” of “Products,” defined in Section 1.11 as items “covered by a Valid Claim” in the assigned BioSante Patents. CG argued that expired patents mean no “Valid Claim,” thus no royalties. ANI countered that royalties apply to CG0070 sales regardless of patent status, as the drug stems from the transferred technology.
Interpretation Dispute: The court ruled that both interpretations are plausible, requiring extrinsic evidence (e.g., negotiation history) to resolve. Judgment on pleadings was premature without discovery.

Summary Judgment: CG’s alternative motion also failed because material facts—like the intent behind the royalty terms—remain disputed, necessitating a trial or further proceedings.

Who Appears to Be Winning?

ANI Pharmaceuticals Holds the Edge (As of Now):
Motion Denial Favors ANI: By rejecting CG’s attempt to dismiss the case outright, the court has kept ANI’s claims alive. This suggests ANI’s argument—that royalties extend beyond patent expiration—has enough merit to warrant further scrutiny, shifting the burden back to CG to disprove it.
Discovery Advantage: The ruling opens the door to discovery, where ANI can seek evidence (e.g., emails, drafts) to support its broader royalty interpretation. If ANI can show the parties intended royalties to cover CG0070 sales irrespective of patent status, it strengthens their position.
Market Context: CG0070’s Phase 3 success (75% complete response rate, per BioPharma Dive, May 2024) and CG’s $1B+ valuation post-IPO (Pharmaphorum, January 2024) bolster ANI’s claim that CG is profiting from the transferred tech, aligning with ANI’s royalty expectations.
CG Oncology’s Position Weakened, But Not Out:
Setback: CG’s strategy to end the case early failed, signaling their patent-expiration defense isn’t airtight on paper alone. The court’s ambiguity finding undermines their core argument for now.

Potential Recovery: CG could still prevail if discovery reveals the agreement was explicitly meant to limit royalties to active patent terms—or if they prove CG0070’s revenue hinges on unpatented innovations unrelated to ANI’s contributions.

Current Trajectory

ANI’s Favor: As of March 12, 2025, ANI appears to be “winning” in the sense that they’ve survived CG’s dismissal attempt and gained a procedural foothold. The denial of CG’s motion keeps the case alive, favoring the plaintiff (ANI) at this stage, as defendants typically seek quick resolutions in contract disputes.
Unresolved Outcome: No final winner exists yet—this is a preliminary ruling. The case will likely proceed to discovery, then trial or settlement, unless new motions shift the landscape. The court’s focus on ambiguity means the outcome hinges on evidence neither side has fully presented.

Caveats

Post-November 2024 Updates: I lack access to filings or hearings after November 18, 2024. If a new ruling or settlement occurred between then and now, it could change the picture—check Delaware Superior Court dockets (C. A. N24C-03-022-SKR CCLD) for updates.
Settlement Risk: Pharma disputes often settle before trial, especially with CG’s IPO and ANI’s growth focus (e.g., $148M Q3 2024 revenue, per ANI’s November 2024 report). A quiet resolution could moot the “winner” question.

Conclusion

ANI Pharmaceuticals appears to be ahead as of the November 18, 2024, ruling, with CG Oncology’s dismissal bid rejected and the case moving forward. ANI’s chances now depend on leveraging discovery to prove their royalty claim, while CG must regroup to clarify the agreement’s intent.

Thank you Brusselsspirit. This is great news.

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.

Thank you JTFM. The Tezruly situation is a very strange one. I think it is more than six months since it was approved.

Could be Silvr. Thanks.

On a side not National Drug Code protocol uses the distributor code on the label. When looking at the NDC database Inzirqo is listed under ANIP's label, but Tezruly code is no longer available as ANIP withdrew it s marketing

INzirqo

Tezruly shows the following:

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Tezruly

Looks to me like Tezruly with be distributed under a different label, whether sold or out licenced. While ANIP will distribute Inzirqo.

This could be another reason for no FDA approval yet for a female testosterone product. They made some substantive changes in the label for the men's product, including removing the black box warning based on the Traverse study results. I think this is good news for our eventual approval since it sets a precedent for no cardiac or stroke risk for men (other than higher blood pressure). I would hope our ten year study would provide comparable data for women.

New Testosterone Label

I found he host much more informed than previous hosts. Still no questions regrading Tezruly and Inzirqo.

Silvr my thought as well when I saw the PR.

Finally a good question from today's investor conference. The host called out the challenge of the low multiple for generics being applied to the rare disease business which is now half of the company, and whether they have considered doing anything about it. Nikhil's answer in brief was maybe.

I agree.

Good news. Thanks JTFM. It is very telling that they immediately announced this approval but not the others.

Corti pre-filled syringe got approved.

Approval

Can't argue with the lack of transparency. But, I am not concerned about the selling. I believe any insider buys before ANIP announces the approval of Tezruly and Inzirqo, would likely be considered insider trading.

It must form part of a larger announcement (e.g. partnership, spin off, etc..) otherwise they would have already announced them, as most companies do.

Personally, rather than acquire another company, I would like to see them start paying dividends next year, when cash flow is suppose accelerate quickly. Every time they buy something cashflow takes a hit for a little while. Once they start paying dividend, it will make any institutional tug of war, in relation PPS, less frustrating.

JMHO

Well, not enough transparency in my opinion . Questions : why insiders are just selling and never buying ?

Figures, we get a share price upgrade to 94 and the stock declines 4%. Looks like it is market wide for small caps.

Correction, it was their 4th patent for Corti.
US 11975047 B1
US 12102662 B1
US 12133831 B1
US 12233105 B1

Either M&A or rapid growth. Either way, it bodes well for ANIP.

Yes, most interesting. Gee, I wonder what insider information they are referring to?

The other thing I found interesting was in the discussion of leases:

We currently lease office space in Princeton, New Jersey, which is our commercial headquarters, which includes certain employees in our corporate, legal, human resources, business functions, and rare disease operations. The leases will expire between 2025 and 2028. We also entered into a new lease
agreement for office space in Princeton, New Jersey, which is expected to have a commencement date during 2025. The Princeton, New Jersey lease will have a remaining term of approximately 10 years.

It is confusing since they reference already occupying their "commercial headquarters". This is what is referred to on their website as the 500 Alexander Park location. However, they talk about entering into a new 10-yr lease at a Princeton location during 2025. Maybe the start of the new lease coincides with any M&A activity.

Silver, I found it interesting that the 10-k incudes exhibit 19.1 Insider Trading Policy. I haven't seen it in previous 10-k filings.

Possibly, I also wonder if the realignment of Brands with Rare Disease for revenue recognition is part any deal (future sale or spin off).

Just started reading the 10K and the first thing I noticed on page 3 is that these two trademarks were not listed as being owned by ANIP. Doesn't this solidify that they have been sold to someone else?

It will be back to 57 in no time. Congrats on another good quarter that will bring the PPS nowhere

Of course this will be one of the analyst questions today. Not.

Good earnings and still no news on Tezruly and Inzirqo

JTFM, Yes i do believe something is there in the future. I believe it will be a buyout and that is why I'm hanging in here. I have been long ANI for years now, and all the news that comes out is always good, constant approvals etc. Only problem is the PPS doesn't reflect the news. I don't think anything is there for the female testosterone, obviously i could be wrong, but i am hanging my hat on the generics they have out but mostly on Corti. I don't understand how shareholders are not calling for heads to roll as their investments have gone nowhere in years. They were going to sell the company a some years ago and i believe that is still in the cards. I can't stand hearing about the small amount of shares or the manipulation, just seems like the same old song and dance.

ANIP picked up a third patent for Corti today(Reference USPTO patent US 12233105 B1)

Bagel, I agree that the lack of growth in PPS and company secrecy is annoying. It has been going on for years, All we can do research information they can't hide and speculate on why they are withholding important info, and won't discuss it. With only 20 million shares this stock can be easily manipulated, as we have seen it climb over 20% with no news and drop the same way without any reason on many occasions. .

Though you do not voice it, you obviously believe there is something brewing that should benefit shareholders, and FOMO has kicked in, otherwise you would have sold and moved on.

Hopefully, Friday will put an end to the secrecy.

Good luck to all.