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ANI Pharmaceuticals and Alimera Sciences Announce Closing Date of Merger

PRINCETON, N.J. and ATLANTA, Sept. 11, 2024 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (NASDAQ: ANIP...

Form 4 - Statement of changes in beneficial ownership of securities

ANI Pharmaceuticals Provides Update on Closing of Acquisition of Alimera Sciences

PRINCETON, N.J., Sept. 10, 2024 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (“ANI” or “the Company”...

Form 4 - Statement of changes in beneficial ownership of securities

Form 8-K - Current report

ANI Pharmaceuticals, Inc. Closes $316.25 Million Convertible Senior Notes Offering Including Full Exercise of Initial Purchasers’ Option to Purchase Additional Notes

PRINCETON, N.J., Aug. 13, 2024 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq:...

Form 8-K - Current report

ANI Pharmaceuticals, Inc. Prices Upsized $275.0 Million Convertible Senior Notes Offering

PRINCETON, N.J., Aug. 07, 2024 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq:...

Form 8-K - Current report

ANI Pharmaceuticals, Inc. Announces Proposed Convertible Senior Notes Offering

PRINCETON, N.J., Aug. 07, 2024 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq:...

Form 10-Q - Quarterly report [Sections 13 or 15(d)]

Form 8-K - Current report

ANI Pharmaceuticals Reports Second Quarter 2024 Financial Results and Raises 2024 Guidance

Generated record quarterly net revenues of $138.0 million, representing year-over-year growth of 18.4%, and...

ANI Pharmaceuticals to Discuss Second Quarter 2024 Financial Results on August 6, 2024, at 8:30 a.m. ET

PRINCETON, N.J., July 31, 2024 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (“ANI” or the “Company”...

silvr_surfr 11 horas hace

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

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Just the facts maam 11 horas hace

Looks like Sandoz can launch a generic Lizness in 2030.

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Just the facts maam 12 horas hace

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.

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silvr_surfr 13 horas hace

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.

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Just the facts maam 13 horas hace

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.

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Just the facts maam 14 horas hace

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

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silvr_surfr 14 horas hace

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

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Just the facts maam 17 horas hace

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

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Just the facts maam 2 días hace

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

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Roddy4 2 días hace

Thanks !! Happy new year dear friends !!

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big bambino 2 días hace

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.

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Just the facts maam 3 días hace

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

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Just the facts maam 3 días hace

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

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Just the facts maam 3 días hace

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

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Just the facts maam 3 días hace

Nothing is simple and straight forward with ANIP. Chad may still participate, as stated in the Linkedin post. He just won't present. Might be there to answer questions. Mary on the other hand will present on something.

ANIP presented new pre-clinical data highlighting its membranous nephropathy (MN) research during two poster presentations at the American Society of Nephrology (ASN) Kidney Week 2024 in San Diego, CA, October 23-27. Where they had two posters.

According to Mary Pao, the data shed light of the potential role of melanocortin receptors in the underlying disease pathologies within nephrotic syndrome. The research contributes to the development of valuable research tools and models for studying membranous nephropathy. She stated that the findings represent the first steps in ANI’s commitment to advancing the science underlying certain disease pathologies.”

Two poster presentations demonstrate ANI’s commitment to research in membranous nephropathy care

Aside from the NDAs, I wonder if they will announce the launch of a Phase 1 clinical studies. This would show that ANIP is further distancing itself from its generic and specialty pharma roots.

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silvr_surfr 3 días hace

So now the official press release does not have Chad included in the presentation. Always the mystery with these guys.

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Just the facts maam 3 días hace

The Linkedin post even had a slide with photos of the four participants. I agree they are not bringing Gassert and Pao to sit on the sidelines.

Mary could also be there to elaborate on
https://investor.anipharmaceuticals.com/news-releases/news-release-details/ani-pharmaceuticals-present-new-data-highlighting-membranous

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silvr_surfr 3 días hace

Precedent aside, it does not make sense to have Chad there to say we can't talk about specific acquisition targets. There must be a completed deal that will be discussed. This fits with what has been going on the past many months.

In Mary's case, there was also the Cortrophin pre-clinical work that was done, but I think they already mentioned it and it is not anything of investor value at this point.

Lastly, there is still no announcement on the website for the JPM conference. My guess is that the person responsible for posting is out of the office and the execs are excited about sharing this, so got it posted themselves on LinkedIn.

We will know soon enough.

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Just the facts maam 4 días hace

ANIP's top Institutional investors now are
BlackRock
Vanguard
JP Morgan Chase & Co.
and
Goldman Sachs.

JP Morgan revised their ownership from 554,840 shares in Q3 to 1,109,670 shares.

They obviously see it as undervalued.

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Just the facts maam 4 días hace

Slvr, I have looked at a number of transcripts from past presenters and very few list the CMO or CSO as participating, mostly CEOs and CFOs. It is an investors conference.

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silvr_surfr 4 días hace

Mary Pat posted this on her Linked In:

Looking forward to J.P. Morgan in 2025!

Whatever the discussion, it looks like she is excited about it. Let's hope it translates well to an improved valuation.

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silvr_surfr 4 días hace

It is odd how the LinkedIn posts are more timely than the main website. The 1/14 conference has not been posted there and there was never any announcement of the Princeton site either.

It will be great to finally get some clarity on what is going on. We know that it includes some kind of a deal and involves new clinical information.

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Just the facts maam 4 días hace

Good point. New Day readout is not until Q2, so she is definitely there for something else.

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Just the facts maam 4 días hace

Interestingly, both Eyepoint Pharma and MBX Biosciences are scheduled to present at the same time as ANIP. Possibly a coincidence, but Eyepoint manufactures Iluvien and Yutiq. While MBX is a clinical-stage biopharmaceutical company focused on the discovery and development of novel precision peptide therapies for the treatment of endocrine and metabolic disorders. According to Corti's label- Purified Cortrophin Gel is a porcine derived purified corticotropin (ACTH) in a sterile solution of gelatin. It is made up of a complex mixture of ACTH, ACTH related peptides and other porcine pituitary derived peptides.

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silvr_surfr 4 días hace

Great news JTFM. Both Chad and Mary's participation are telling. I believe there is an Iluvien read out coming later this year from one of the clinical trials, so Mary must be there for something else of clinical significance. It is most certainly connected to the mystery NDA, it is just a question of for what. You called a JV or co-promotion of testosterone gel a.long time ago and these facts support this.

Of course I am going to be out of pocket on the 14th so may not be able to listen to the call if it gets broadcast.

GLTA

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Just the facts maam 4 días hace

From looking at other presenters, including much bigger companies, most only have their CEO and CFO's presenting. Looks like they are getting ready to answer a number of technical questions, that is where Poa and Gassert step in.

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Just the facts maam 4 días hace

According to their Linkedin page:

ANI Pharmaceuticals, Inc. will participate in the 43rd Annual J.P. Morgan Healthcare Conference in San Francisco next month, which is taking place Jan. 13-16, 2025. ANI CEO Nikhil Lalwani will be presenting on Tuesday, January 14 at 2:15pm. Other ANI participants include Chief Medical Officer Mary Pao, CFO Stephen Carey, and SVP, Corporate Development Chad Gassert.

Possibly a coming out party. They have 4 Execs presenting. I imagine they expect a lot of questions. Oddly, Christopher Mutz - Head of Rare Disease is not included.

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Just the facts maam 6 días hace

Good article supporting ANIP's oral solution strategy, especially for NDA's with patent protection.

Crushed Tablet Administration for Patients with Dysphagia and Enteral Feeding: Challenges and Considerations

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Just the facts maam 1 semana hace

Hope you and your family have a happy holiday season as well.
Same goes for the rest of the board members.

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big bambino 1 semana hace

Would like to wish everyone a merry Christmas and happy holiday's

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Just the facts maam 1 semana hace

Roddy, Bagel, I understand your frustration. If you do exit, I wish you both the best in future investments.

I will be riding it out to the end. Might be a fools errand.

I agree that the buyout in the short-term seems less likely. But I disagree on nothing happenning. Whether it moves the needle depends companies like BlackRock (2,689,712 shares) and (Vanguard 1,348,111 shares). When they want out, all the good news we have had will likely be reflected in the PPS.

Hopefully it will happen soon.

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Roddy4 1 semana hace

I agree with you bagel123. There are no signs that something big is going to happen shortly.No insiders buying( actually the other way around .. we saw a lot of selling) . I also do not believe an acquisition is around the corner , it would be the first time that an acquisition is made with no insiders buying , no rumors in the market , nothing at all. As matter of fact we have seen the sp declining constantly. Like you I am planning an exit . I have been waiting for too many years.

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Roddy4 1 semana hace

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bagel123 1 semana hace

JTFM, thx for the response. I know that you seem very knowledgeable about ANI, but the fact is that this stock has done nothing for investors as my $ sits dead with them. What may or may not be the future is very speculative. There has been no sign of anything that would deem otherwise. No significant insiders buys only a few sells, not enough to worry about. Its almost like nobody want this to move up. As i stated the news is always good with new drugs to market etc. Ive heard many time on this board that the institutions don't want it to go up blah blah blah. I believe if they had a cure for cancer the stock would go down or stay the same price. I have owned for 5+ years and has been a terrible investment, i do feel married to it so i guess i will just ride it out

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Just the facts maam 1 semana hace

The returns are real, unfortunately the lack disclosure by the company is also real. Possibly, a condition of what ever deal they have in place.

Not launching Tezruly upon approval, sure brings into questions their motto- "Serving Patients, Improving Lives". Just something they may want to consider.

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bagel123 1 semana hace

This stock is crap, been here way too long with way too many shares. Management gives shareholders nothing at all. Some holding on for what "may" be in the works, a lot of speculation. Truth is there has been no return this year (-2%). 5 year (-15%). This company always comes out with good news and earning beats quarterly, yet nothing. Seems like a giant scam to me

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silvr_surfr 2 semanas hace

Great sleuthing JTFM as always. Like you have said before, don't watch for what they say, but what they do. This is great evidence that the Tezruly delay was planned. Sammy must be getting a good deal otherwise. Painful watching the stock near 52 week lows with all of the progress in the past year and material new prospects.

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Just the facts maam 2 semanas hace

In the 2023 Q2 10-Q filing ANIP recorded the contingency consideration to pay Sammy and company as commencing in 2024 . Meaning they intended to launch Tezruly in 2024, Yet , the following quarter, after filing two NDAs, one financed by a partner, ANIP pushed back the contingency consideration starting in 2025. Certainly looks like the deal for Tezruly, and likely one or both other NDAs, was struck in Q3 2023.

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Just the facts maam 2 semanas hace

Thanks Silvr. I agree that ANIP is not pulling any punches. The addition may add pressure to reach a settlement.

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silvr_surfr 2 semanas hace

A big gun attorney, Stephen Rabinowitz, got added to our team for the CGON case. Here's a write up I found on him:

Stephen has been profiled in the “Intellectual Property Trailblazers” list by The National Law Journal, recognizing top legal professionals in the United States who have “moved the needle” in intellectual property law. In addition, he was named Lawyer of the Year for Biotechnology and Life Sciences Practice in New York City in 2024 edition of The Best Lawyers in America©. He is also recognized by Managing Intellectual Property, The Legal 500, and IAM Patent 1000.

The full court press is on. Just like everything else, we have more waiting. I don't think we would take on the added cost of this if we were not bullish in the outcome. Similarly, I don't think a high caliber person like this would take the case, if they did not think they would win.

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Just the facts maam 2 semanas hace

Looks like rebalancing. Other stocks are having similar high volume.

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Just the facts maam 2 semanas hace

Almost 1.2 million shares traded at close. More shorts exiting or approval rumors?

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Just the facts maam 2 semanas hace

I would not be surprised if the downturn over the last couple of sessions was used by many to exit short positions. Institutions should be set for the pending run.

On a side note, BPAX intended to set Libigel at a cost $8-$10/day to treat HSDD back in 2012. I wonder what it will be priced at in 2025, with CV and Breast Cancer event reduction data.

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silvr_surfr 2 semanas hace

Thank you JTFM. A complicated situation to be sure. I did not remember the connection to Abbvie with regard to the Dudley patent. I suppose this is one more point in their favor as a potential partner. What a day that will be if we actually can make cardiac and/or breast cancer reduction claims. It is good to hear that there can be some patent protection even for HSDD claims.

It sure looks like ANIP has been trading for some time in a downward channel. I thought we would break out of it after Q3 results, but no such luck. Today, it appears we touched the bottom of the channel and bounced back. It was painful to watch, but it looks like we are headed back up. Those algorithms are nasty.

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Just the facts maam 2 semanas hace

Silvr, I forgot to mention that in ANIP's patent prosecution of administering testosterone to reduce CV events, the reason for denial was that Dudley's prior claims had been assigned prior art (owned by AbbVie). The problem, may have been that this allowed Besins in on a deal. The patent appears to be sitting there waiting to be issued if AbbVie assigns rights to the prior art and adds Dudley to the list of inventors. If Dudley's name had appeared as an inventor on the patent application the secret partnership would have been exposed. The delay may have been linked to AbbVie finding a way to maximize the benefit to AbbVie, at Besins' expense. They also may have secured the prior art by ANIP making the breast cancer reduction claim in December 2015 in their prosecution of the CV patent. Arguably they could be looking at filing new patent applications once testosterone is approved. Paying the USPTO fee, gets the HSDD patent protection as far as 2033, and filing the CV patent (very good chance of approval ) and breast cancer patent applications once approved. This could extend patent protection past 2044.

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Just the facts maam 2 semanas hace

Even though AbbVie still list Androderm on their products page . The Orange Book shows that it has been discontinued.

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Just the facts maam 2 semanas hace

Thanks Silvr, it would be nice, assuming there is a settlement, I think it will come close to when CGON is ready to file the NDA or the pre-trial conference, ANIP seeking to revoke CGON's rights to the NDA, as a possible remedy, could cause delays in the FDA reviewing an NDA, which is added pressure .

I can't conceive that a BOD would let this go to trial, where a jury could send a strong punitive message which could tank CGON's PPS. The risk is not worth the reward.

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silvr_surfr 2 semanas hace

CG Oncology closed its public offering. Hope we get a nice settlement for xmas. Their fiscal year ends on 12/31 so maybe this is a driver too.

Another affidavit was filed on our behalf recently so we are not taking the pressure off. If we don't see a settlement, I suspect this means that we are bullish about winning the case or are holding out for an even bigger settlement.

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silvr_surfr 2 semanas hace

Oh boy, what a proverbial tangled web. As you pointed out quite a while ago, this must be one of the reasons they needed an army of lawyers for the Novitium deal. I wonder how Sammy is getting compensated for the Tezruly delay.

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Just the facts maam 2 semanas hace

As I understand it Besins and Unimed (Solvay/Abbott/AbbVie) developed Androgel. With Unimed only North American right to Androgel. Abbott/AbbVie outsourced the manufacturing. This why the subsequent IP has been shared 50/50 between Besins and Unimen/Abboot/AbbVie.

As I understand, it AbbVie currently owns all of Androderm.

Libigel was developed between ANIP and Antares, where ANIP later gained the manufacturing rights. I don't think Besins was involved, as initial patents were assigned to Antares with some Biosante employees listed as inventors(e.g. Simes). The CV reduction patent application did not include Besins or Antares though the Breast Cancer reduction patent application Patent and Breast cancer patent application did not mention anything about Besins and no new inventors were added. Though as it relates to CV reduction, in one patent prosecution the reviewer assign prior art to Robert Dudley (Unimed/ Solvay) I an sure if this is shared with Besins. This does not appear to be the case regarding Breast Cancer reduction. yet, it has not been fully argued.

As you said Besins could be a partner, but if AbbVie is involved, I believe the steps taken were to free themselves from having to share IP rights with Besins.

JMHO

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ANI Pharmaceuticals Inc (ANIP)

Discusiones en tiempo real e ideas comerciales: opere con confianza con nuestra poderosa plataforma.

ANIP Noticias

ANI Pharmaceuticals and Alimera Sciences Announce Closing Date of Merger

Form 4 - Statement of changes in beneficial ownership of securities

ANI Pharmaceuticals Provides Update on Closing of Acquisition of Alimera Sciences

Form 4 - Statement of changes in beneficial ownership of securities

Form 8-K - Current report

ANI Pharmaceuticals, Inc. Closes $316.25 Million Convertible Senior Notes Offering Including Full Exercise of Initial Purchasers’ Option to Purchase Additional Notes

Form 8-K - Current report

ANI Pharmaceuticals, Inc. Prices Upsized $275.0 Million Convertible Senior Notes Offering

Form 8-K - Current report

ANI Pharmaceuticals, Inc. Announces Proposed Convertible Senior Notes Offering

Form 10-Q - Quarterly report [Sections 13 or 15(d)]

Form 8-K - Current report

ANI Pharmaceuticals Reports Second Quarter 2024 Financial Results and Raises 2024 Guidance

ANI Pharmaceuticals to Discuss Second Quarter 2024 Financial Results on August 6, 2024, at 8:30 a.m. ET

ANIP Discussion

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ANI Pharmaceuticals Inc (ANIP) Noticias

ANI Pharmaceuticals Inc (ANIP)

Discusiones en tiempo real e ideas comerciales: opere con confianza con nuestra poderosa plataforma.

ANIP Noticias

ANI Pharmaceuticals and Alimera Sciences Announce Closing Date of Merger

Form 4 - Statement of changes in beneficial ownership of securities

ANI Pharmaceuticals Provides Update on Closing of Acquisition of Alimera Sciences

Form 4 - Statement of changes in beneficial ownership of securities

Form 8-K - Current report

ANI Pharmaceuticals, Inc. Closes $316.25 Million Convertible Senior Notes Offering Including Full Exercise of Initial Purchasers’ Option to Purchase Additional Notes

Form 8-K - Current report

ANI Pharmaceuticals, Inc. Prices Upsized $275.0 Million Convertible Senior Notes Offering

Form 8-K - Current report

ANI Pharmaceuticals, Inc. Announces Proposed Convertible Senior Notes Offering

Form 10-Q - Quarterly report [Sections 13 or 15(d)]

Form 8-K - Current report

ANI Pharmaceuticals Reports Second Quarter 2024 Financial Results and Raises 2024 Guidance

ANI Pharmaceuticals to Discuss Second Quarter 2024 Financial Results on August 6, 2024, at 8:30 a.m. ET

ANIP Discussion

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