ANI Pharmaceuticals (ANIP)

[Just the facts maam]

Yet again, no announcement on Inzirqo or Tezruly. Obviously guidance excludes these drugs. Must saving to after approval of Authorization increase to make an offering of some type. Analyst have obviously been instructed not to ask about the drugs. simply googling the drugs and you can see it is for sale and discounts are being offered.

[Brusselsspirit]

Results are out. All good except Yutiq/Iluvien for Q1. Interesting update just now in CC by Steve (CFO). CGON trial will be on July 21 this year. If you want to listen it's around 30 minutes into the call.

[Just the facts maam]

Novitium picked up an approval for Hydrocortisone.

Approval

[Just the facts maam]

Thanks Silvr. It makes me wonder if ANIP's hire of Alex Divkovic as a Algorithm Developer from Sweden is seriously looking at using AI for customization.

Linkedin

[silvr_surfr]

Here is a good article about testosterone use. An interesting take on the future including the use of AI to customize treatment and the role private equity may play.

Testosterone Has Become Big Business

[Just the facts maam]

Thanks Silvr

[silvr_surfr]

Finally, an analyst from Leerink Partners calls out the CGON lawsuit as an opportunity,

Faisal Khurshid has given his Buy rating due to a combination of factors including ANI Pharmaceuticals’ potential financial benefits from their involvement with cretostimogene, a promising product in bladder cancer treatment. ANIP is currently in litigation over its rights to a 5% royalty from the worldwide net sales of cretostimogene, which could be a significant revenue stream if the litigation is resolved in their favor.
Additionally, ANIP’s strategic shift from a traditional generics manufacturer to a hybrid model that includes branded rare disease drugs positions it well for future growth. The company’s unique US-based manufacturing capabilities for generics and its commercial growth in branded products further support the positive outlook. Khurshid believes that the market may be underestimating these factors, making ANIP a solid investment opportunity in the current market conditions.
Khurshid covers the Healthcare sector, focusing on stocks such as Pliant Therapeutics, aTyr Pharma, and Kymera Therapeutics. According to TipRanks, Khurshid has an average return of 26.3% and a 45.59% success rate on recommended stocks.

[silvr_surfr]

Not unusual at all, nope. Just 450K shared traded already today and at least 2M over the past week or so, Short interest gets reported on Friday along with our Q1 earnings, Will be interesting to see what is going on. You would expect to see more of a face-ripper with this volume, but not today.

[silvr_surfr]

Thank you JTFM.

[silvr_surfr]

Thank you JTFM.

[Just the facts maam]

I did a little digging and the additional formulation does not appear to be for testosterone . It looks like it is for Amytriptyline Hydrochloride, currently only available in tablet form. I imagine they are likely introducing an oral solution formulation of the drug. The following is from Clincalc.com

Estimated number of prescriptions in the United States (2022) 7,887,977
Estimated number of patients in the United States (2022) 1,675,744

[silvr_surfr]

Good find. Maybe this explains the 1M shares traded yesterday. Short interest only came down a couple hundred thousand shares in the mid-April report. Like you said, May will be interesting.

[Just the facts maam]

For comparison, Pharmacompass list 133 finish dosage formulations for Novitium which is consistent with what is listed in the Orange Book.

[Just the facts maam]

I think the 3rd NDA, the one believed to be partnered (possibly for female testosterone), has been approved.

Though the Orange Book publicly display 430 finish dosage formulations for ANIP, Pharma compass lists 431 finish dosage formulations.

The Orange Book list all approved non-biologic drugs. Though there are certain reasons where the publication can be delayed.

Pharmacompass

[Just the facts maam]

Looks like ANIP has recently listed Inzirqo in their products pages, however they have yet to add the link to the prescribing information which is already publicly available.

Products

Prescribing Information

[Just the facts maam]

Thanks Silvr. Since CGON has dragged their feet or contested discovery on many issues, it looks like they may be trying to delay the trial by extending deadlines.

[silvr_surfr]

CGON has a conference call on Monday AM. I am sure it will just be to discuss the results and not announce any settlement. I will listen anyways. In the trial. CGON filed a recent "EXPEDITED MOTION TO EXTEND CASE DEADLINES" so it is not clear what is happening.

[Just the facts maam]

Single Care is also offering Tezruly at a discount. It indicates retail for the drug is $500.

Tezruly Discount

[Just the facts maam]

Thanks Silvr. All the more reason to get the litigation resolved. It is becoming a bigger gamble to go to court, as there is no idea what type of punitive damage a court could impose, if CGON were to lose.

[silvr_surfr]

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

[Just the facts maam]

Thanks Silvr.

[Just the facts maam]

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.

[Roddy4]

… and no PR at all?

[Just the facts maam]

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.

[silvr_surfr]

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

[silvr_surfr]

Thanks for keeping us updated JTFM.

[Just the facts maam]

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

Approval

[Just the facts maam]

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.

[Just the facts maam]

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.

[Roddy4]

Yes , very strange indeed

[Just the facts maam]

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

[Roddy4]

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

[Just the facts maam]

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.

[Just the facts maam]

Happy Easter to all.

[Just the facts maam]

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.

[Easka]

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.

[silvr_surfr]

Same to you bb.

[big bambino]

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

[silvr_surfr]

Nice. Enjoy.

[Just the facts maam]

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.

[silvr_surfr]

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.

[Just the facts maam]

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.

[Just the facts maam]

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.

[silvr_surfr]

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.

[silvr_surfr]

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

[Just the facts maam]

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/" rel="nofollow" target="_blank" >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]

[Just the facts maam]

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

[Just the facts maam]

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

GoodRx

[silvr_surfr]

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.

[Just the facts maam]

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.