ANI Pharmaceuticals (ANIP)

[DEVJ]

Nice bump today; however (for me) there's still a long way to go to get back to my BPAX cost basis

[bagel123]

Hopefully it finishes up today....

[Easka]

BB I couldn't agree more. The market seems a agree, as well. Nice 30% pop out of the gate today.

[big bambino]

Easka, it seems we have and then some. Looks like we're at the start of something really special

[big bambino]

Just the facts Maam, It looks like we're going on a looooong ride, . I'm so happy for everyone one here who had faith, all the way from BPAX. Also want to thank you and all the contributors for posting and keeping us informed.

[Easka]

Yes loved the huge beat and raise, even better than I would have hoped. Still I think the full year Corti revenue guide is to low.

[Just the facts maam]

Nice earnings report. Revenue up form last quarter even though Corti was lower than last quarter (as expected). What I like most is the gross profit margins continue to increase Q over Q. In the last call Lalwani stated the margins would stay around 61% as royalty revenue decrease would offset some of the gains made by sales of their products.

[Just the facts maam]

Silvr, we know that Novitium had three 505(b)(2) drugs for hypertension and oncology in the works when acquired. It looks like oral suspension Hhydrochlorothiazide was one, another being Terazosin Oral liquid which probably won't be as lucrative.

In 2020, 2,285,079 prescriptions of Terazosin were issued at average of 15.53 (generic drug). I figure it will likely generate peak sales of $60 million, unless the oral solution brings back patients who used nearly 6 million prescriptions in 2013. If so, you could be looking at $120 million a year in peak sales.

Not sure what the third drug will be unless it is Carglumic Acid which they have a patent for an easier to store version of Carbaglu.

Interestingly a study found that carglumic acid induced apoptosis in various cancer cells in vitro.

Drug repurposing offers the advantages of time and cost savings stemming from the fact that the drug being repurposed has already passed toxicity and safety testing and therefore has a reduced chance of failur]. In this study, we found that carglumic acid, which is conventionally used to treat hyperammonemia, has anticancer activity. We found that carglumic acid induced apoptosis in various cancer cells in vitro. Our results indicated that carglumic acid inhibits proliferation of human pancreatic cancer, triple-negative breast cancer, hepatoma, and lung cancer cells by inducing apoptosis. Importantly, carglumic acid is a relatively safer anti-cancer agent than gemcitabine or paclitaxel, which is in agreement with the fact that no serious safety issue has been identified for the use of carglumic acid in treatment of hyperammonemia. Carglumic acid also demonstrated potent antitumor activity in vivo in orthotopic mouse models of human pancreatic and breast cancer. Together, these findings demonstrate a novel anticancer function of carglumic acid, with less toxicity than that of chemotherapeutic agents. Carglumic acid therefore represents an effective alternative for cancer treatment.

Study

Good luck to everyone tomorrow.

[silvr_surfr]

Thank you JTFM. This is very compelling. Novitium has made a big bet on liquid formulations for good reason. I am sure there will be more coming since it is an excellent way to differentiate and plays very well to the demographics.

Good luck to all tomorrow.

[Just the facts maam]

If Novitium brings an oral suspension hydrochlorothiazide (patent pending) to market. It should be huge.

Apparently 25% of hospitalized patients and 30%-40 % of those in nursing homes have trouble swallowing.
Evaluating Dysphagia

In 2020, 41,476,098 prescriptions of Hydrochlorothiazide were issued at average of $7.76 (generic drug) .

Arguably with patent protection to November 2042, ANIP could have a long run with this drug with peak sales exceeding $500 million.

GLTA on Monday

[Easka]

BB Second that. Lets see beat and raise Monday.

[big bambino]

I want to wish everyone to have a great weekend with a warm welcome on Monday

[Just the facts maam]

Easka, you may be right about them holding off until Monday. I don't know how big a market it is, but every little bit helps.

[Easka]

JTFM Thanks for sharing. I wonder why they have not issued a PR for this approval that was dated 5/1? Maybe they plan on the PR for Monday AM along with earnings release?

[Just the facts maam]

Novitium picked up an approval for the only generic for Pfizer's Celontin (Methsuximide).

Approval

[Just the facts maam]

Thanks Silvr,

That is quite impressive.

[Just the facts maam]

The presentation didn't add much from the earnings CC.

However, the slide presentation did make slight change from the previous presentation.

From Poised for Return to Strong Financial Growth

to

Ani Pharmaceuticals is Well Positioned to Drive Sustained Profitability.

[silvr_surfr]

Here's how the audience called the results:

'Fantastic,' 'Terrific' Results With Oncolytic Virus Combo for Bladder Cancer

[silvr_surfr]

Thanks for the reminder auh2oman.

[auh2oman]

Reminder...

There's a presentation today at noon:

https://investor.anipharmaceuticals.com/news-releases/news-release-details/ani-pharmaceuticals-present-hc-wainwright-bioconnect-investor

[silvr_surfr]

Since DHEA breaks down to testosterone, maybe Pill Plus will be part of the same deal. It would make perfect marketing sense.

[silvr_surfr]

Here is piece of the updated Androgen Restored Contraception page on the Pantarhei Bioscience website:

The Androgen Restored Contraception (ARC) project is in phase III development and a phase IIb/III clinical study is ongoing in Europe. Based on scientific advices obtained from regulatory authorities (EMA and FDA), only a limited phase III program is required.

Check out the FDA note. I think we may soon find out what all of those lawyers were doing during the Novitium deal.

[Just the facts maam]

Very good results indeed. Thanks Slvr.

[Just the facts maam]

Correction: The equity MVP gave up in ANIP to BPAX share holders is now valued at close to $165 million and at one time would have been worth over $370 million.

[silvr_surfr]

Thanks as always JTFM. This has been my investment thesis as well. I cannot recall a similar situation where there existed such a ready-made market without an approved product. When you add the potential for cardiac and breast cancer claims, it is extraordinary. Good luck to all.

Here's a follow up on CG0070's presentation at the AUA conference. Some excellent results...

Phase 2 Data Show Clinical Activity With CG0070 Plus Pembrolizumab in NMIBC

[Just the facts maam]

Silvr, to my knowledge, MVP has only one investment that they have held when it went public, ANIP. They have held it since the merger with BPAX. The equity they gave up in ANIP to BPAX share holders is now valued at close to $165 million and at one time would have been worth over $37 million. They were also a subsidiary of Wells Fargo at the time.

The way I see it, BPAX's initial patent application the reviewer assigned prior art to Dudley's application as it relates to CV event reduction, however Dudley's application was missing supportive data, which ANIP has in spades. Complicating matters was that Dudley's application was in a 50/50 sharing agreement with Besins Healthcare and Abbott/AbbVie.

In relation to Breast Cancer event reduction, ANIP has established prior art in their patent application prosecution on December 19, 2015.

AbbVie also now owns all the Intrinsa data.

Libigel safety and efficacy trial data is due to be posted October 27, 2023 or before.

Hard to believe there is not a master plan tying it all together to maximize profits and sustainability. I envision future patent application(s) to maximize patent coverage.

JMHO

[silvr_surfr]

I did not consider the importance of MVP sticking with us as further evidence of an eventual payout from Libigel. I agree this makes sense. I am still holding on to ABBV so yes it got whacked yesterday.

I found the below article about a program the CDC is sponsoring to better standardize testosterone testing. This has to help our cause when it is most difficult to test for women.

CDC TT Testing

[Just the facts maam]

Thanks Silvr. I find it hard to believe that MVP would not ensure that ANIP would from Libigel trial data. AbbVie's PPS got hit today as Humira's revenue replacement is now being questioned. If AbbVie is interested, They may want come out of the closet. I guess we will find some time this year.

I agree that some of their drugs will be sold. I am not certain if Art still has a relationship with AKORN.

[silvr_surfr]

Thanks JTFM. No, I did not see that. Here is some more info on the study. There is certainly a there, there. Just remains to be seen if we ever profit from it.

New study to see whether a skin cream can prevent heart failure in women

Separate topic... did you see that Akorn is now bankrupt and removed all of their products from the market because they could not ensure quality? That will present some acquisition targets no doubt. I wonder if Art is advising them?

[Just the facts maam]

Silvr, not sure if you posted about this, but Susan Davis is at again.

Evaluating Testosterone Therapy to Prevent Heart Failure in Women: The ETHEL Study.

[Just the facts maam]

Bagel123, retail investors only own about 13 %. We are at the mercy of the institutional games until they want it to climb. They will play with it and continue accumulating, while they can. Low volume makes it easy to control. I expect this to continue until big news comes out creating volume that makes it difficult to control PPS.

[bagel123]

why do we go down on new drugs introduced ready for sale?

[silvr_surfr]

Oh, I missed the most important point of the letter... we are in phase 3 now!

[Just the facts maam]

Thanks Silvr, Interesting information.

[Just the facts maam]

In Q1 earnings ANIP should be able to report income from the liquidation auction of their Oakville facility which closed on March 1, 2023.

Auction

Additionally, they have listed the building at $26,200,000.

Listing

[silvr_surfr]

Thank you JTFM.

This letter from the Pantarhei Bioscience CEO was behind a pay wall. They corrected an error in the letter and the correction is now visible. It speaks to the phase 2B Pill Plus trial. Gedeon Richter is finding 60% of women taking COCs in the lead up to the trial had testosterone-related sexual complaints.

A few certainties about testosterone in women

[Just the facts maam]

On April 18, 2023, Novitium was issued a patent regarding a tablet for oral suspension comprising of carglumic acid and its use. Set to expire June 14, 2042.

I was unable to post the link.

You can find the patent by search USPTO Public Patent Search and go to the Basic Search and enter 111628143 into the Quick Lookup box.

[Just the facts maam]

Thanks auh2oman.

[auh2oman]

From Reuters ...


Here's a direct quote:

"We have seen an increase in demand since the ruling earlier this month," a spokesperson for Baudette, Minnesota-based ANI Pharmaceuticals (ANIP.O), one of the companies that makes misoprostol, told Reuters. "We have ramped up our manufacturing and are currently prepared to meet the increased demand we are seeing."


https://www.reuters.com/world/us/one-drug-medication-abortion-with-misoprostol-grows-us-2023-04-20/

[Just the facts maam]

Regarding - Lalwani's statement

While we’re proud of these impressive achievements, we believe that our most significant opportunities to continue serving patients in need and drive growth and profitability lie ahead.

ANIP's annual report lists Morgan, Lewis & Bockius LLP as legal counsel. Legal 500 ranks Morgan, Lewis & Bockius LLP as a second tier US law firm in Life Sciences.

Ranking

In just over a year ANIP has hired Meredith W. COOK as Senior Vice President, General Counsel and Corporate Secretary, and Elizabeth POWELL as Chief Compliance Officer and Head of Legal, Rare Disease, and are now looking to hire a paralegal.

It looks like upcoming deal(s) are in the works.

[Just the facts maam]

Novitium picked up approval for Nitrofurantoin oral suspension.

Approval

[silvr_surfr]

I get it now. Nikhil said 20M prescriptions which would include multiple individual dosages. The California news was for the tablets themselves. It is at least an order of magnitude difference then.

[Just the facts maam]

It doesn't look like the sale of 2 million misoprostol tablets will be as meaningful as hoped.

California expects to pay $800,000 for the 2 million prescriptions.

Newsom's office said on Monday the state spent $100,000 on the 250,000 pills. If the state decides to buy 2 million it would cost roughly $800,000.

Misoprostol

[Just the facts maam]

Thanks Silvr.

[Just the facts maam]

Thanks dasgrunt.

[Just the facts maam]

I agree Silvr. Nice find Auh2oman.

Silvr, I like this line in Lalwani's letter.

While we’re proud of these impressive achievements, we believe that our most significant opportunities to continue serving patients in need and drive growth and profitability lie ahead.

I read that as Corti not being ANIP's most significant growth opportunity. It looks like he is pointing more than one opportunity that can surpass Corti's expectations.

JMHO

[dasgrunt]

applied for importer of controlled substance

https://www.federalregister.gov/documents/2023/04/04/2023-06949/importer-of-controlled-substances-application-ani-pharmaceuticals-inc

[silvr_surfr]

Here's something to look forward to at the end of the month:

New Phase 2 Data With Cretostimogene Grenadenorepvec (CG0070) in Combination with KEYTRUDA® (pembrolizumab) in BCG-Unresponsive NMIBC at the AUA 2023 Annual Meeting

This looks to be our most promising commercial cancer drug from the Biosante portfolio.

[silvr_surfr]

Thanks auh2oman. That is great news. Nikhil published a letter today ahead of the annual meeting in May. In it, he references ANIP's delivery of 20M prescriptions in 2022. 2M for misoprostol alone is material.

[auh2oman]

Thanks ...

Interestingly, ANI launched their version of Misoprostol Tablets, 100 mcg and 200 mcg exactly one year ago today. It is the generic version of the Reference Listed Drug (RLD) Cytotec®. Mr. Lalwani is quoted in the press release:

"We are pleased to announce the launch of AB rated Misoprostol Tablets. The AB rating indicates that our product meets necessary bioequivalence requirements, thus is therapeutically equivalent to the RLD. This rating provides us with an advantage versus other available generics. In light of the recent drug shortage, the commercialization of Misoprostol Tablets highlights our commitment to rapidly bringing limited market competition generic products to our patients in need and to our customers."

https://www.businesswire.com/news/home/20220411005212/en/ANI-Pharmaceuticals-Announces-the-Launch-of-Misoprostol-Tablets