ANI Pharmaceuticals Inc (ANIP) Options

Hot off the presses... Excellent results posted for the CG0070 Bond-003 trial. Also looks like there was excellent performance for a new indication. Price tag just went up.

Bond-003 Trial

Thanks Silvr.

ANIP does not appear to be hiring for Tezruly or Inzirqo. I wonder if the drugs are so well established, that they will sell themselves when an oral solution is announced. If so, this would be great for profits. Or, they could have a partner on deck.

… and no PR at all?

Looks like Tezruly has been unofficially launched. Patents can not get discount coupons on the drug.

Tezruly Coupon

America Pharmacy's coupon put the price of Tezruly at $96.80. Since America Pharmacy's discounts are as high as 80%, Tezruly's retail price is likely $484 for 30 ml.

This will help analyst price in revenue estimates for the drug when analyzing ANIP.

As the only FDA approved alpha blocker in oral solution formulation, this should get interesting. In 2022, alpha blockers listed as alternatives sold approx. 40 million prescriptions. Tezruly, as the only approved oral solution, should take market share from the other alpha blockers and compounded drugs not included in the 40 million.

May should be an interesting month.

For anyone still keeping track of GVAX, here are a couple of notable events. I doubt we still have any licensing rights to them, but it is cool to see the technology advancing.

Briacell's Bria-OTS (GVAX derived) reported complete resolution of lung metastasis in all patients after 4 months of their Phase1/2 clinical trial for women with metastatic breast cancer.

Bria-OTS

WDVAX (the technology that originally brought me to be a Biosante investor) presented topline results from its Phase 1 study. The article is behind a paywall, but sounds like it was well tolerated and produced the desired immune response, but it is silent about the performance. In the original clinical studies in mice, these implants produced dramatic reduction in melanoma.

WDVAX

Thanks for keeping us updated JTFM.

Looks like Novitium picked up approval for a mesalamine ANDA on April 16th.

Approval

Looks like ANI was reworking their prescribing guidelines for Tezruly. It now shows a Marketing Start date of April 18, 2025

Tezruly

Maybe we see both Tezruly and Inzirqo getting launched into Q1 earnings.

Google search AI response to "Why do analyst not ask obvious question to CEO?" included:

Maintaining a harmonious relationship:
Some analysts prioritize maintaining a positive relationship with the CEO over asking potentially challenging questions, even if those questions could reveal crucial information.

Yes , very strange indeed

Either they have been asked not to discuss the drugs, or incompetence. Personally, they can't all be incompetent.

I cannot understand why analysts do not ask questions about Tezruly and Inzirqo. Very strange!!!

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.

Happy Easter to all.

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.

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.

Same to you bb.

Happy Easter to everyone and happy holidays to all, Gary.

Nice. Enjoy.

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.

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.

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.

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.

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.

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

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]

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

Though the price for Inzirqo is not publicly available yet. GoodRx shows the price as low as $2,160.

GoodRx

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.

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.

Here is hoping!

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

Thanks JT,
Nice to see they put the Pessimistic outcome first and leaves the optimistic outcome for the final paragraph, lol.

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.

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.