ANI Pharmaceuticals Inc (ANIP) 옵션

A news story "Alcami Announces CEO Transition" for ANIP from PR Newswire was triggered at 1/13/2025 11:12 AM.

Thanks for the updates JTFM. I was not available to listen this time. A team-building shopping trip is a good explanation as any for them first saying the business development guy would be there, then just Mary Pao and then neither of them shows up.

Here is a favorable article from Zachs. They sure bounce around, but it is a good read for anyone having any doubts about our future, even without all of the hidden assets we have been discussing.

Zachs Research on ANIP

So Mary Pao was not at JP Morgan to present. Maybe she was there as part of company shopping/partnering trip.

Listened to JP Morgan presentation. No mention of Tezruly or other NDAs.

They want to send the message that hey are now and will be predominantly a rare disease company with support from a complex generic business.

It almost looks like they will sell or out licence the NDAs and use the funds to finance rare disease growth. I am ok with this but why the secrecy.

Unlike other CEO's lalwani will not give peak sales estimates but speaks patient numbers that can possibly benefit from Corti. Good to hear that acute gouty arthritis has an addressable patient population of 300,000. This iworks out to an addressable market of over $2 billion. How much of the addressable market ANIP can capture remains to be seen, but even 10% is $200 million in sales for the one indication.

Maybe we find out more this week.

Me neither

Truist maintains a Hold rating. Never seen such a strange context for a stock...

Forbes article "Three Under-The-Radar Growth Stocks Poised To Double In 2025" list ANIP as on of the three stocks. I commented giving info regarding Tezruly and the other two NDA's not factored into ANIP current revenue estimates for 2025.

Article

Hopefully, Forbes will help get ANIP some traction.

I agree the numbers look strong and Lalwani once again left lots on the table. He has to be bound by some type of disclosure restrictions. If there is deal to be announced at the JPM Conference it would be by the larger partner. AbbVie does not present until the 15th. I have also seen deals announced a week or two after the conference, to avoid competing with all the other pharma news.

I did like seeing 14% growth in Corti revenue over Q3 almost $60 million in Q4.

Hopefully, some has done their homework and ask Lalwani for an update on Tezruly and the other two NDAs. If Lalwani repeats the following, as he did to Oren Linvat of H.C. Wainwright:

"So, Oren, on the 505B2s, we will share more when we have meaningful updates to give. But there's no linkage between the litigation spend and the launch of 505B2 products. But we will share updates on that when there are material. "

Hopefully, they follow up with:

What do you mean by meaningful? And when can we expect a meaningful update?.

Thanks JTFM. Looks like we won't be getting a deal announcement. It is strange that they are essentially communicating Q4 results. The numbers look very strong so hopefully we see the stock price react accordingly and get far way from this 52 week low.

I suspect Mary Pao's presentation will focus on the "research" areas called out in the deck and will not be talking about testosterone. This company is such the mystery given they are silent on so many things. I guess we will have to read the 10Q to see if it provides any info. Our share price has suffered ever since the shorts took their 2M position. Hopefully, we get some news that will put them on their heels. Perhaps we saw some covering today given the high volume.

ANIP posted their presentation for the JP Morgan Healthcare Conference. No mention of Tezruly or other NDA's.

They must be selling or out-licencing them. Leaving it to to buyer to make announcement(s).

If ANIP is intending on marketing Tezruly, their strategy sure questions their motto "Serving Patients, Improving Lives".

Presentation

--Alcami Corporation, a leading contract development and manufacturing organization, today announced the resignation of Bill Humphries. In addition to his duties at Alcami, he currently serves as Chairman of ANI Pharmaceuticals, Inc., Chairman of MedPharm, and is an Operating Partner at Ampersand Capital Partners. Alcami's private equity ownership includes.

Can anybody explain why every time the announce results that apparently seems good , SP declines 2/3%?

Can anybody explain why every time the announce results that apparently seems good , SP declines 2/3%?

Thanks Silvr.

Thanks Silvr, hard to say how it will play out. There are reasons to settle out for both, but good reasons not to settle.

I would not be surprised if CGON screwed up in some of their out-licensing deals and lowered their royalty rate to the point where all the royalty money they receive would go to ANIP. I doubt they included ANIP in the licencing agreement.

If they are being bought out, they will buyout ANIP's stake in the drug. If not. I think they eventually go back to the terms of the agreement and pay ANIP's legal fees. This way, in the event that the FDA does not approve the drug, they have not thrown away their money.

I follow the progress of our "Pill Plus". It is a mystery here too since the reporting on the European Union clinical trial is not clear and Pantarhei Biosciences appears to have closed its doors. Here is a very recent paper highlighting the negative impact the standard hormonal contraceptives have on several bone metabolism markers:

COC Impact on Bone Metabolism Markers

If there is a deal in the works, it will be interesting to see if our rights to this product are included. Pantarhei Biosciences closing suggests that it will.

We are deposing CGON again later this month on the 23rd. My guess is that this will be to address items uncovered during discovery. Good to see the pressure being kept on.

This also suggests that a settlement has not occurred. CGON did the offering so there is more than $200M available. Wonder if we said no. Regardless, it seems bullish that we are back in front of them with hopefully some meaty discovery findings.

Interesting, Silvr.

Thanks Silvr, this would make diagnosing low testosterone much more efficient.

Revvity is the renamed Perkin Elmer company after they spun out part of it to focus on diagnostics. Interestingly, Ampersand Capital (Patrick Walsh) sold one of their portfolio companies to Perkin Elmer in 2021.Is this just a coincidence or part of a larger strategic plan?

The razor/blade strategy fits here since you sell the product (the razor) and then you also sell the upfront and ongoing tests to maintain the product's use.

Sorry, could not resist. Here may be another piece of the puzzle - the first FDA approved automated test for free testosterone. The testing range and indications appear appropriate for women which has been an issue up to this point.

Revvity Automated Free Testosterone Test

This could also have been one of the things that "they" have been waiting for. Doctors will need these tests run to prescribe the product. It also looks like a more practical alternative to the liquid chromatography/mass spec currently recommended.. The automation should also reduce the costs.

Most interesting JTFM. I would think "they" would need to have patent protection in place before launching. Perhaps this has been one of the reasons for the delay. Your finding adds to the intrigue. It would make sense to hold back publication of a granted patent until the whole deal is communicated. What a strong patent if they are able to incorporate ten years of clinical data in it.

I sure hope the curtain is pulled back on the 14th.

Silvr, something interesting regarding patent application # 13/135,999.

It had a child. patent application # 15/288,511, which has never been published. It was filed 10/07/2016 and was subsequently abandoned. When I query # 15/288,511 this is the response I get.

Sorry, the entered Application Number '15/288,511' is not available. The number may have been incorrectly typed, or assigned to an application that is not yet available for public inspection.

Preserving certain trade secret, proprietary, and protective order materials qualify as reasons to not publish patent applications.

It makes me wonder if they had a court order protecting this application from being published, as it would expose a partnership. Could it have mirrored patent application # 15/331360 titled "Methods for treating Female Sexual Dysfunction while decreasing cardiovascular risk", where the data would exposed a partnership. It could have been abandoned for the same reason. The reviewer wanted the CV reduction claims and the Breast Cancer reduction claims in separate applications as each are assigned to separate divisions for review.

If the above is true, then ANIP reacquiring rights to the patent application approximately one month after the certification request to delay submitting trial results seems well orchestrated.

I imagine ANIP will be become more transparent from the 14th onward. Especially when the partnered drug is approved.

I took a spin through all of the ANIP patents to see if there have been any changes - nope. I did notice something I have not before and maybe you already called this out JTFM. For the key cardiovascular patent for testosterone (2012002033A1), it was originally assigned to the ANI Pharmaceuticals entity and, after being used as collateral, came back with the ANIP Acquisition company added as an assignee as of 11/24/21 (see below). Interestingly, this is just a couple of days after the Novitium acquisition closed.

Application US13/135,999 events

(2011-07-20) - Application filed by Biosante Pharmaceuticals Inc
(2011-07-20) - Priority to US13/135,999
(2011-08-29) - Assigned to BIOSANTE PHARMACEUTICALS, INC.
(2012-01-26) - Publication of US20120022033A1
(2013-12-16) - Assigned to ANI PHARMACEUTICALS, INC.
(2016-05-13) - Assigned to CITIZENS BUSINESS CAPITAL, A DIVISION OF CITIZENS ASSET FINANCE, INC., AS AGENT
(2017-12-29) - Assigned to CITIZENS BANK, N.A., AS ADMINISTRATIVE AGENT
(2021-11-24) - Assigned to ANI PHARMACEUTICALS, INC., ANIP ACQUISITION COMPANY

Isn't this where it would get parked for any potential deal? We know there was an army of lawyers involved in the Novitium acquisition so this could be one of the outcomes. I think it is the only patent (across the 48 records in Google Patents), that is assigned to this entity. Can't help myself. Trying to solve the mystery ahead of the 14th.

Thank you JTFM. Hopefully, medical benefits of testosterone for women is part of Mary Pao's discussion on the 14th. Probably not.

Another reason begging for an approved female testosterone drug

Correlation between low testosterone levels and the risk of osteoarthritis: a cross-sectional analysis of NHANES data (2011–2016)

Conclusion

Low testosterone levels are independently associated with an increased risk of OA in the U.S. population. These findings underscore the potential role of hormonal health in OA pathogenesis and highlight the need for longitudinal studies to clarify causal pathways. The observed non-linear relationship suggests that maintaining optimal testosterone levels may be important for joint health, and testosterone replacement therapy could be explored as a preventative strategy for individuals with testosterone deficiency.

Correction: ANIP appears to be using NCD code # 70954-592-10 for Tezruly. However, when searching Tezruly or this code in the NCD directory it does not produce a result.

I agree, hopefully the cat and mouse game with investors will come to an end on the 14th.

I noticed that there is no National Drug Code for Tezruly. I believe if ANIP were going to launch Tezruly, they would have already obtained a NDC Id # which would identify the manufacturer and distributor. Whether it is sold, out-licenced, launched by a newly formed joint venture, or an ANIP spin-off remains to be seen.

We know they have Tezruly in their back pocket. Updates on NDAs would be great. However, the biggest news next week could be announcing a big pharma partner, with the partner taking the vacant position on the BOD.

When I look at the ANI website again, it looks like the "Product" button has two functions. If you click it, you get the full product list. If you hover over it, you get a drop down for the new medical information page. I don't know if this was changed or I just did not see this the first time. Not sure a spin out is in the cards or not. January 14 can't come soon enough.

Easka, as I understand it, as long as it is treated as a dividend, shareholder approval is not required .

A spin-off is a stock dividend paid by a firm to its current shareholders consisting of shares in an existing or newly created subsidiary. No shareholder approval is required because only the board of directors may decide the amount, type, and timing of dividends. Such distributions are made in direct proportion to the shareholders’ current holdings of the parent’s stock. As such, the proportional ownership of shares in the subsidiary is the same as the stockholders’ proportional ownership of shares in the parent firm. The new entity has its own management and operates independent of the parent company. Unlike the divestiture or equity carve-out (explained later in this chapter), the spin-off does not result in a cash infusion to the parent. After the spin-off, shareholders own both parent company shares and shares in the unit involved in the spin-off.

Spin Off

Basically we would get one share of the new company for each share of ANIP. Market's would dictate ill dictate what the value would be of each company. The ANIP shares would go down in value but we would gain shares in the new company. Abbott Labs spun off AbbVie in 2013 and both were priced at around $33, down from around $66 for Abbott prior to the spin-off. They have each paid quarterly dividends as PPS grew substantially. I guess we will soon see what ANIP is up to.

JTFM "spinning off the Company as dividend" Are you thinking they would spin off generics and established brands as a separate company, or a direct sale to another company. Selling the generics to another company was what I was thinking, based on their recent actions and the last conference. Are you sure about no shareholder approval required for a spin-off?

Silvr, selling part of the company would require shareholder approval. However, a spinning-off the company as a dividend does not appear to require shareholder approval. This could be done quickly.

Thanks Silvr, A spinoff or sale is very possible. I guess we will find out over the next 8 days.

Here is a direct link to the new medical info page

New Product Page

Thanks JTFM. So here's something strange. When I go to the ANIP website, the product section has changed. It is now geared towards medical professionals only and, importantly, only lists the three rare disease products. Is this a tip of the hand which means the surviving ANIP entity will be.a rare disease only company and the remainder of the company goes somewhere else?

New Website Home Page


It is strange since you get different versions of the home page. If you don't see the different products section in the link above, click in the ani logo on the upper left and then open the products section. Given the oddity of this, it cannot be accidental. It also means they must be close to doing something since they appear to be getting the new website teed up.

Only 4 trading days before JP Morgan Healthcare conference starts and 5 days before ANIP presents.

The waiting should be over soon.

That would be awesome and I can see payers doing that.

Looks like Sandoz can launch a generic Lizness in 2030.

Silvr, I noted that United Health had all three covered with prior authorization. As the only generic, and a reduced price, I wonder if the prior authorization will be removed, or at the very least I see it being the first drug tried before authorizing the any of the others, at least for CIC.

United Health Coverage


Regarding CG Oncology litigation, I wonder if that was suggested by RABINOWITZ.

Thanks JTFM. Syphoning would be good.

I don't know if this is a big deal or not, but in the last two records posted on the CGON lawsuit docket, ANIP is now referred as "PLAINTIFF ANI PHARMACEUTICALS, INC. F.K.A BIOSANTE PHARMACEUTICALS, INC." It was never referred to this way in all of the prior records.

Tezruly is still listed on ANIP's products page. Hard to say if they will launch, out-license or sell it.

Maybe start small and work up to bigger announcements going into the conference.

ANIP announces launch of a generic Motegrity. IQVA sales estimate $168 million market. This lower than the 2022 estimate of $350 million. However Motegrity competes with Linzess and Trulance, both have no generic alternative. ANIP might be able to syphon sales from both, as well. AbbVie reported sales of $693 million for Linzess over 9 months in 2024. Trulance sales were not available.

ANIP PR

According to Drug.com, this is how they compare:
Motegrity Alternatives

Looks like they got the party started early with the generic Motegrity announcement. It is quite telling that they announce this before Tezruly.

Generally, companies make big announcements prior to a conference to allow participants to organize the sessions they will be attending. ANIP has enough PR info held back that they could make a PR release each day next week going into the JP Morgan conference to create interest from investors. Announcing their partner at the conference would be the cherry on the top.

The following is an example
Monday - Tezruly approval and launch or sale
Tuesday - Generic Motegrity approval and launch
Wednesday - Identify the drug, indications and PDUFA date for NDA filed in Q1 2024
Other possibilities
- Moving headquarters
- Announce submission of application for self injectable Corti
_ IND application for membranous nephropathy for clinical trials
- Any other deal they are cooking up.

Conference - Joint release on ANIP partnership with larger pharma company and update on NDA filed and provide long term strategy for growth with a pipeline for the company.

JMHO

Thanks BB hopping everyone here has a Happy and Very Profitable Year!

Thanks !! Happy new year dear friends !!

I would like to wish all my friends on the best board in Ihub, a very and healthy new year for them and all their families, God Bless.

If Lalwani included Generic Motegrity in his assessment that Rare disease would represent over half of ANIP's revenue in 2025. ANIP's revenue estimates should be raised to over $1.1 billion for 2025, excluding sales from Tezruly and the other two NDA's

Novitium gained approval for a generic Prucalopride Succinate. The therapeutic equivalence to Teva's Motegrity, with no other competition. According to Market Edge Dynamics the US market was $350 million in 2022 and expected to grow to $550 million by 2030.

Approval

Market

Word is starting to filter out.

Henry Turner of Investor Hangout describes it as follows:

ANI Pharmaceuticals, Inc. (Nasdaq: ANIP) is gearing up to make a substantial impact at a prominent industry event. The Company will be represented by Nikhil Lalwani, its President and Chief Executive Officer, along with Stephen Carey, the Chief Financial Officer, and Dr. Mary Pao, the Chief Medical Officer. Their presentation will take place at the 43rd Annual J.P. Morgan Healthcare Conference, scheduled for January 14, 2025, at 2:15 PM PST.

ANI Pharmaceuticals Announces Significant Conference Participation