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ANI Pharmaceuticals Inc

ANI Pharmaceuticals Inc (ANIP)

68.00
-1.21
(-1.75%)
At close: 22 April 6:00AM
68.00
-0.17
( -0.25% )
After Hours: 6:01AM

Calls

StrikeBid PriceAsk PriceLast PriceMidpointChangeChange %VolumeOPEN INTLast Trade
35.0031.1036.000.0033.550.000.00 %00-
40.0026.1031.000.0028.550.000.00 %00-
45.0021.2026.000.0023.600.000.00 %00-
50.0016.5021.300.0018.900.000.00 %00-
55.0011.8016.500.0014.150.000.00 %00-
60.007.5012.200.009.850.000.00 %00-
65.003.908.506.206.20-1.16-15.76 %21305:00:30
70.002.103.804.072.950.000.00 %07-
75.000.205.001.362.600.000.00 %021-
80.002.354.802.353.5750.000.00 %0103-
85.000.003.900.000.000.000.00 %00-
90.000.004.800.000.000.000.00 %00-

Professional-Grade Tools, for Individual Investors.

Puts

StrikeBid PriceAsk PriceLast PriceMidpointChangeChange %VolumeOPEN INTLast Trade
35.000.004.800.000.000.000.00 %00-
40.000.004.800.000.000.000.00 %00-
45.000.004.800.000.000.000.00 %00-
50.000.003.900.000.000.000.00 %00-
55.000.004.800.000.000.000.00 %00-
60.000.154.001.502.0750.000.00 %02-
65.000.553.705.552.1250.000.00 %04-
70.002.507.204.504.85-5.68-55.80 %2305:25:05
75.006.0010.000.008.000.000.00 %00-
80.009.5014.400.0011.950.000.00 %00-
85.0014.5018.900.0016.700.000.00 %00-
90.0019.5024.000.0021.750.000.00 %00-

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ANIP Discussion

View Posts
Just the facts maam Just the facts maam 8 hours ago
Either they have been asked not to discuss the drugs, or incompetence. Personally, they can't all be incompetent.
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Roddy4 Roddy4 8 hours ago
I cannot understand why analysts do not ask questions about Tezruly and Inzirqo. Very strange!!!
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Just the facts maam Just the facts maam 1 day ago
Easka, Tezruly is puzzling. It was approved and I remember that marketing authorization was stopped the day it started August 1, 2024 The Orange Book showed it as discontinued for a short period of time, but was no longer discontinued in September or October. Usually, if drugs are not marketed within 180 days of approval they are discontinued.

It is equally strange that Tezruly is listed as an ANIP product but the prescribing information is archived. While Inzirqo is not listed as a product. Yet if you search the Daily Med (linked to NIH) it lists Inzirqo, but does not list Tezruly.

Good Rx list Inzirqo prices as low as $2,160, while it does not even list Tezruly.

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Just the facts maam Just the facts maam 1 day ago
Happy Easter to all.
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Just the facts maam Just the facts maam 1 day ago
Silver, of the 11.76 million shares available, 8.29 million are accounted for. This leaves ANIP with 2.88 million shares left for business development, potential future dividends (more importantly dividend reinvestment), etc...

As of March 24, 2025, we had 592,963 shares held in treasury and 8,287,643 shares of our common stock subject to outstanding stock options and performance-based stock units, subject to other convertible securities, and reserved for our Amended and Restated 2022 Stock Incentive Plan and Amended and Restated 2016 Employee Stock Purchase Plan, thereby leaving 2,878,553 shares of common stock unassigned and authorized for potential issuance of the current 33,333,334 shares of common stock authorized. If the Share Increase Amendment is approved, there will be 35,545,219 shares of common stock unassigned and authorized for potential issuance. If approved, the Share Increase Amendment will not change the number of shares of Series A Preferred Stock or Class C Special Stock authorized for issuance.


These purposes may include, but are not limited to:
•expanding our business through the acquisition of other businesses, products or assets;
•establishing partnerships and strategic relationships with other companies;
•raising capital through the future sale of our common stock when necessary or appropriate; and
•attracting and retaining valuable employees by providing shares available for equity incentives.

The Board believes that it is desirable and in the best interests of the Company and its stockholders to have a sufficient number of additional shares of common stock available for issuance from time to time, as the occasion may arise, for future financing and acquisition transactions, to permit stock dividends or stock splits at some future date, equity incentives for employees, and for other proper corporate purposes. Therefore, the Board has approved, and unanimously recommends that the stockholders of the Company approve the Share Increase Amendment.

The following are incidents I found where increasing authorized shares benefited shareholders.

Corcept biopharma - 2012 increase in authorized shares trading at Approx. $4 now trades at $63

Array biopharma - October 2018 increased authorized shares trading at $16, 8 month later Pfizer offered to acquire Array for $48 per share.

Personally, I would like the option of reinvesting dividends in the future, so the company needs more authorized shares.

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Easka Easka 2 days ago
JTFM, I was just on the ANI products page and it does list Tezruly. No PR , yet listed on their site? Not sure what happens if someone tries to order it. Very strange. Happy Easter to all.
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silvr_surfr silvr_surfr 3 days ago
Same to you bb.
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big bambino big bambino 3 days ago
Happy Easter to everyone and happy holidays to all, Gary.
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silvr_surfr silvr_surfr 6 days ago
Nice. Enjoy.
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Just the facts maam Just the facts maam 6 days ago
Silver, I am away right now, with spotty internet service, but beautiful beaches. Will look at it when I get back. Might request clarity on Tezruly and Inzirqo before voting on approving more shares.
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silvr_surfr silvr_surfr 1 week ago
Hey JTFM. What is your take on the proxy vote to essentially double the number of available shares for the company. You have spoken about this before and the impact of few available shares for various business uses. Also, the details say there are ~11M shares outstanding. I recall you saying there were very few remaining. Is this because of the convertible notes?

Thanks.
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Just the facts maam Just the facts maam 2 weeks ago
Thanks Silvr, regarding mediation, I see that they made similar entries on February 4th and 5th. Maybe they are mediating parts of the case, or hopefully, as you suggested a settlement. If it is settlement related, the CGON shelf offering could pay for the settlement.
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Just the facts maam Just the facts maam 2 weeks ago
I agree ANIP looks good when compared to the markets especially when looking at Year to date results. Personally. I believe the $40.6 million of net proceeds from a convertible offering that was used to enter into capped call transactions, with a cap price of $114.02 per share, aiming to reduce potential dilution to ANI's common stock upon conversion of notes, is also playing a role keeping PPS down.
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silvr_surfr silvr_surfr 2 weeks ago
Here's the latest entry from the docket for our lawsuit with CGON:


APRIL 3: LETTER FOR JUDICIAL REVIEW DATE DOCKETED: APRIL 5, 2025 LETTER TO THE HONORABLE SHELDON K. RENNIE FROM MICHAEL J. FARNAN REGARDING MEDIATION ACCEPTED BY: ERM TRANSACTION ID: 75998664

Maybe we are headed to mediation for a settlement.
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silvr_surfr silvr_surfr 2 weeks ago
More good news JTFM, thank you. Volume this past week has been very high with 700k shares traded on Friday, but share price has stayed fairly flat. This is actually good given how the broader market has performed which is a proof point for the iBD article,

The reasons I can think of are:

1) Per the article, investors sought us out on a purely defensive basis. I would have thought we would see share price growth if this were the case. Maybe this is unrealistic given market conditions.

2) The shorts have been given an orderly exit ahead of expected good news. Short interest grew after the financing deal to a total of 2.5M this past month. We should know soon if they exited or not.

3) A deal is coming and an acquirer (and/or friends) are accumulating shares. Again, I would expect a price increase if this were the case. While it is a small bet (~$15K), the largest call option for April 17 is at $75. With the price of the option, this call will only make money above $80. We will know about this one soon as well.

GLTA
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Just the facts maam Just the facts maam 2 weeks ago
IBD 50 includes ANIP as one of 50 defensive stocks during the market plunge we are experiencing. It is one of 44 stocks that have held up well in comparison to the markets.

IBD 50 identifies 50 growth stocks showing strong relative price strength and top-notch fundamentals found in Innovator Capital Management's IBD 50 ETF (FFTY).

https://www.investors.com/research/mckesson-in-huge-group-new-to-ibd-50-check-out-which-stocks-just-came-on-and-off-ibds-top-stock-screens/[tagInnvestor Business Daily[/tag]
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Just the facts maam Just the facts maam 3 weeks ago
According to the preliminary proxy statement, it looks like ANIP is still keeping a seat on the Board vacant. Hard to believe it is not related to the partner who is financing the third NDA. It is likely why they are withholding the official launch of Tezruly and Inzirqo.

JMHO
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Just the facts maam Just the facts maam 3 weeks ago
Though the price for Inzirqo is not publicly available yet. GoodRx shows the price as low as $2,160.

GoodRx

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silvr_surfr silvr_surfr 3 weeks ago
Thank you JTFM. This is great news. Did not have him speaking at an ophthalmology conference on my bingo card. I think your assertion is right about the new hires. I just wonder if they will present the topline results at the conference. We will know soon enough.
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Just the facts maam Just the facts maam 3 weeks ago
Nikhil Lalwani, President and Chief Executive Officer, will host a fireside chat at the 2025 RBC Capital Markets Ophthalmology Virtual Conference as follows:
Date: Thursday, April 3, 2025
Time: 7:45am ET

ANIP also has 6 Ophthalmology Account Executive openings on their website, Probably an indication that they like the topline data from the New Day study.
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Just the facts maam Just the facts maam 3 weeks ago
Here is hoping!
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silvr_surfr silvr_surfr 3 weeks ago
Thank you JTFM. This certainly does not fully reflect all of the remedies that ANIP is seeking (e.g. pull all of the transferred assets).

CGON just filed a broad shelf registration statement. It is odd given the investor presentation that was just published (see below), where they say they have a cash runway through the first half of 2028 (over $0.5B cash on hand). Maybe this is how they fund a settlement.

Shelf Registration

Latest Investor Presentation
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big bambino big bambino 3 weeks ago
Thanks JT,
Nice to see they put the Pessimistic outcome first and leaves the optimistic outcome for the final paragraph, lol.
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Just the facts maam Just the facts maam 3 weeks ago
CG Oncology's latest 10-k filing provides their shareholders with very little information regarding the ANIP litigation.

Legal proceedings, government investigations and enforcement actions can be expensive and time-consuming. For example, on March 4, 2024, a complaint was filed in the Superior Court of the State of Delaware by ANI Pharmaceuticals, Inc. (ANI) naming us as defendant, seeking a declaratory judgement that a provision in an assignment and technology transfer agreement between us and ANI (formerly BioSante Pharmaceuticals, Inc.), dated November 15, 2010, obligates us to pay ANI 5% of worldwide net sales of cretostimogene. The court has most recently set a trial date of July 21, 2025. While we continue to believe the allegations are without merit and intend to vigorously defend this matter, such litigation could result in substantial costs and divert our management’s attention from other business concerns, cause us reputational damage, negatively affect our stock price and result in monetary damages and future royalty obligations, if and to the extent cretostimogene receives regulatory approval. An adverse outcome resulting from any legal proceedings, investigations or enforcement actions could result in significant damages awards, fines, penalties, exclusion from the federal healthcare programs, healthcare debarment, injunctive relief, product recalls, reputational damage and modifications of our business practices, which could have a material adverse effect on our business, financial condition, results of operations and prospects. Even if such a proceeding, investigation or enforcement action is ultimately decided in our favor, the investigation and defense thereof could require substantial financial and management resources.
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Just the facts maam Just the facts maam 4 weeks ago
Possibly. It would definitely help in rolling out female testosterone.
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silvr_surfr silvr_surfr 1 month ago
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.
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Just the facts maam Just the facts maam 1 month ago
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

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silvr_surfr silvr_surfr 1 month ago
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
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silvr_surfr silvr_surfr 1 month ago
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..
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Just the facts maam Just the facts maam 1 month ago
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.
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silvr_surfr silvr_surfr 1 month ago
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.
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Just the facts maam Just the facts maam 1 month ago
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
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silvr_surfr silvr_surfr 1 month ago
Great news JTFM. Thank you.
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Just the facts maam Just the facts maam 1 month ago
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.
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Just the facts maam Just the facts maam 1 month ago
Inzirqo's patent protection filed with FDA extends to January 23, 2044.

Inzirqo
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silvr_surfr silvr_surfr 1 month ago
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.
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Just the facts maam Just the facts maam 1 month ago
Looks like MNK will merge with Endo

Merger

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Just the facts maam Just the facts maam 1 month ago
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%.
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Brusselsspirit Brusselsspirit 1 month ago
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.
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Just the facts maam Just the facts maam 1 month ago
Thanks Silvr
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silvr_surfr silvr_surfr 1 month ago
CG Oncology is presenting a late breaking abstract from "our" Phase 3 study in a couple of weeks:

Late Breaking Abstract
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silvr_surfr silvr_surfr 1 month ago
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.
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Just the facts maam Just the facts maam 1 month ago
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
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Just the facts maam Just the facts maam 1 month ago
Thanks Silvr.
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silvr_surfr silvr_surfr 1 month ago
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.
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silvr_surfr silvr_surfr 1 month ago
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.
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Easka Easka 1 month ago
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.
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silvr_surfr silvr_surfr 1 month ago
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.
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silvr_surfr silvr_surfr 1 month ago
Thank you Brusselsspirit. This is great news.
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Brusselsspirit Brusselsspirit 1 month ago
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.
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