BB, I feel optimistic about ANIP continuing to beat estimates and raise guidance for the foreseeable future for the following reasons.
- Novitium should keep rolling out generic drugs to outpace erosion from competition.
- The market's under estimate Corti's peak sales
- Zero value has been given to female testosterone, with results pending.
- Zero value has been given ANIP's potential royalty and milestone payments for CG Oncology's Cretostimogene.
- Regarding Cretostimogene and female tetosterone, in 2023, 89% of NDA's were approved cancer. So for future filings.
- Though we don't know the details of the Cold Genesys Biosante deal, at the time Biosante was represented by Oppenheimer Wolff & Donnelly LLP the same law firm that hammered out the GVAX agreement with Aduro Biotech. So at a minimum, I expect a clause in the deal covering royalties during the FDA approval exclusivity period (even after patent expiration), just like they did in the GVAX deal. It the deal gave them 5% on Global sales.
- JP Morgan pegged peak sales at $2.3 billion.
- I read an article where effective cancer drugs reach peak sales within 5 years. Assuming it gets approved , JP Morgan is correct regarding peak sales and ANIP is successful in litigation ANIP could receive $530 million in royalties plus milestone payments between 2026 and 2032. This is most likely in addition to any royalties for other indications if approved.

Lots to be bullish about.

GLTA


[tag]https://www.statista.com/statistics/817552/key-measurements-of-us-cder-drug-approvals/[/url][tag]FDA Approval Rate[/tag]

I would like to thank you gentleman once again. With all the info you place here, makes a shareholder feel very optimistic for the future. 😃

Thanks Silvr, the FDA post the Pre-Notices for Potential Noncompliance in submitting trial results quarterly. ANIP was not in the last batch. I think it should not be much longer before it comes out.

Another ten-year study. Hopefully the Libigel study is next.

50% Reduction in Breast Cancer Incidence

Thanks Silvr

We will get a read out on the CG0070 Phase 2 study with Keytruda at the early June ASCO meeting.

CG0070 ASCO Meeting

They probably already withheld a milestone payment, leading ANIP to request a declaratory judgement.

Silvr, if the CG Oncology agreement is similar the GVAX agreement. I find it hypocritical that CG Oncology is stating that they have no obligation to pay ANIP, especially when their agreement with Kissei Pharmaceuticals has a provision to make royalty payments on the first 12 years of commercialization or patent expiration, which ever is longest.

Silvr, that is a very interesting article. Hopefully peer review will support the assertions. If testosterone levels can help regulate your immune system, it has huge implications and yet another reason to get female product on the market.

Regarding monetizing Libigel, we should find out when the results are published. Though the way greedy pharma companies try to weasel out of their agreements does create a concern (e.g, Cabaret and CG Oncology).

That would be great and ahead of any final FDA approval. They probably owe us some milestone payments too.

Thank you JTFM. It would be great to see the Libigel study published. There is certainly a lot of activity in this space. I just hope some of it translates into money in our pocket.

Here's another article.

Long Covid

Here are a couple of parts I like:

The work has yet to undergo peer review, the typical process by which scientific studies are vetted, but I’m highlighting it now given the enormity of need in long COVID — recent data from the Centers for Disease Control and Prevention showed some 8.8 million people in the U.S. were living with the condition in 2022 — and this team’s track record in conducting high quality research.[/I]

]We can’t let the opportunity go to waste. For too long, sex hormone differences have been seen as an inconvenient liability in clinical trials rather than a variable worth considering. Until recently, many drugs were only studied in male mice (lest the results be muddied by fluctuating female hormones) and even human tests skewed toward men.

Meanwhile, chronic conditions like ME/CFS (commonly known as chronic fatigue syndrome), Lyme’s disease and now long COVID, tend to be more common or more severe in women. Time and again, those women’s symptoms are dismissed as psychological rather than physical.

This latest study illuminates our limited knowledge about the role of hormones in chronic disease and should be a clarion call for more work in long COVID and beyond. That can help "start to right the wrongs of this sort of sexism and ableism in women’s health,” says David Putrino, director of rehabilitation innovation for the Mount Sinai Health System, who helped lead the study

Silvr, ANIP commenced an action on June 10, 2019, seeking a declaratory judgment to determine the parties' rights and obligations under the Tripartite Agreement, Escrow Agreement and Assignment Agreement against Cabaret. The decision in ANIP's favor was rendered April 26, 2020. If the CG Oncology matter follows a similar timeline, we will hopefully get a decision in January 2025.

ANI Pharm., Inc. v. Cabaret Biotech Ltd.

A third Female TRT related article in the Journal of Urology May 1, 2024 edition.

MP47-19 EFFICACY AND SAFETY PROFILE OF TRANSDERMAL TESTOSTERONE FOR HYPOACTIVE SEXUAL DESIRE DISORDER: A SYSTEMATIC REVIEW AND META-ANALYSIS

Maybe next month addition of Journal or Urology publishes the Libigel trial study results.

Journal of Urology put out another article regarding TRT and HSDD titled MP47-04 EXAMINING THE TRENDS IN TESTOSTERONE THERAPY FOR WOMEN WITH HYPOACTIVE SEXUAL DESIRE DISORDER

Another study supporting TRT for women. According to PD52-06 TESTOSTERONE THERAPY IN WOMEN IS NOT ASSOCIATED WITH INCREASED CARDIOVASCULAR RISK—A US CLAIMS DATABASE ANALYSIS

Thanks auh2oman.

Thanks for the GVAX info Silvr, as demonstrated by their litigation against CG Oncology, at least they will defend their stake in IP, even if they won't articulate it openly.

From Pharmaceutical Technology ...

https://www.pharmaceutical-technology.com/data-insights/ani-pharmaceuticals-gets-grant-for-powder-for-oral-suspension-with-hydrochlorothiazide-for-hypertension-treatment/

I finished looking at the current status of Biosante GVAX patents. Healthtree is the sole assignee for two of them and shares assignment with Bristol Meyers for a third. Aduro (Chinook) is still listed for others and CG oncology for one as well.

This investment is always full of surprises which is why it has maintained my interest for so long. Here's the latest one. The GVAX trademark is now owned by "Healthtree Inc".

GVAX.com

I can't make heads or tails out of why this "foundation" would own this. However, when you look at the contact info you get directed here:

Meridian Therapeutics

Two of the principals of this company (Borrello and Noonan) are actually the researchers at Johns Hopkins investigating GVAX for multiple myeloma. It is the best testimony that they are now personally involved in its commercialization.

Maybe someday ANIP will get around and share our potential royalty pipeline.

Healhtree Inc is also listed as the assignee now for one of the Biosante patents (US7901902B2) for pancreatic cancer. Don't know the significance of this either.

Thank you JTFM. With the reported continued category expansion, this means that our product must be taking share from them and then capturing all of the category growth. Great news.

According to Mallinckrodt's 2023 Earnings Report, Acthar sales dropped from $140.9 million in Q4 2022 to $104.4 million in Q4 2023. Within two years ANIP has captured approx. 28.5% of the market, and is poised to keep growing market share.

Looks like Sovuna is starting to make the preferred tier of some formularies

Western Sky Community care Preferred Drug List

Silvr, according to the FDA Fast Track process they could have a rolling review.

Thanks again JTFM. Hopefully they did use the same royalty term definition in the CG0070 agreement. That "or" statement could end up having a lot of value. It is sad that we are paying a high royalty to Merck for a decades-old Cortrophin Gel, but CG Oncology is apparently unwilling to do the same.

There will be a 12-month readout on the pivotal phase 3 study coming up in May. I like the comment from their president that “we are excited to share encouraging 12-month Phase 3 monotherapy results from the BOND-003 study at AUA 2024". Any idea when they would begin the FDA approval process? Can they use the 12 month results or do they have to wait until the trial officially finishes next year?

Urology Conference

Silvr, ANIP will have to add it in their filing and I expect they will face question. Though they may be limited in what they will release regarding their legal strategy. It is hard to know what their potential argument might be without seeing the details of the agreement. As I understand it, the Supreme Court has ruled long ago on not being able to collect royalties when the patent expires in the US (1964 decision in Brulotte v. Thys Co.) and Kimble v. Marvel Entertainment, LLC . But neither speak to the lengthy process to commercialize drugs and the effect of conditions outside patent expiration, such as FDA's regulatory 7-year exclusivity period. Interestingly, should it ever stretch out this far, Justices Alito, Roberts and Thomas opinions lead me to believe that they would lean towards backing ANIP's position (assuming a similar agreement to GVAX).

I believe North is more versed in the nuances surrounding patents patents, and may be able to better inform us.

I imagine the terms for CG0070 would be similar to the agreement with Aduro for the GVAX portfolio. If so, it looks like ANIP might have a compelling argument, even if the patents have expired.

Thanks JTFM. What a payday that would be. We better get some questions on this at the next conference call.

Goldman Sachs estimates Cretostimogene's peak sales at $2.4 billion. If ANIP is successful, 5% would add $120 million in royalties per year.

Goldman Sachs starts CG Oncology stock with neutral rating, $42 price target

Though peak sales for Cretostimogene grenadenorepvec has not been identified. It is possible they are looking at peak sales of $3 billion
CG Oncology's Lead Bladder Cancer Drug Offers A Strong Potential Revenue Stream With Buyout Optionality authore dy IPO Kitchen on Seeking Alpha states the following:

North, Biosante speaks about the deal in their filings

Here is the press release when the original deal was done.

Cold Genesys Deal

Were there any previous CG Oncology 10Qs or other SEC filings referring to that agreement?

Silvr, I see that the royalties are for 5% of worldwide net sales. From CG Oncology's 10-K

Thanks Silvr, it blow my mind how they think they can weasel out of royalties. Though they have gotten additional patents more recently, it hard to believe that royalties are not owed, at least on the first 7 years of exclusivity. If they had not entered into the deal they would have nothing. I might be wrong here, but this looks like a potential breach of contract or intent to breach contract. I don't if this could bring the validity of their newer patents into questions, especially in a prior art argument. I think you see CG Oncology end up settling out of court. Especially if they are looking to be bought out.

Thanks auh2oman, early reports coming out of the hearing make it look like the SC is likely to rule in favor ANIP another drug companies favor.

Thanks Silvr. Interesting trial. I note that Kevin Nead the large dementia study has a history of studies linking lowering testosterone to delayed onset of dementia. I think the large study will give an optimal testosterone range help delay dementia. It should benefit both testoterone replacement and reduction therapies.

Make em pay (from the CG Oncology 10K)...

On March 4, 2024, a complaint was filed against us in the Superior Court of the State of Delaware by ANI Pharmaceuticals, Inc. seeking a declaratory judgement that an assignment and technology transfer agreement between us and ANI, dated November 15, 2010, obligates us to pay ANI a royalty on certain "net sales" of cretostimogene. We dispute the allegations and intend to vigorously defend this matter.

Thanks auh2oman.

Today's Oral Argument at The Supreme Court ...

Although it pertains to the drug, Mifepristone, one of the two medications used in chemical abortions. The other is
Misoprostol, which ANI manufactures. Could have an impact. Below is an article from Axios discussing the case:

https://www.axios.com/2024/03/26/supreme-court-abortion-pill-case-fda

Thanks for the update JTFM. Maybe the old adage about a watched pot not boiling applies here. We know this is too big of an opportunity to not do something about it and our product is in the driver's seat. MVP Capital has stuck around too which may be an indicator.

Here's a related trial that is scheduled to be completed early next year.

Evanthea Trial

If you check out the investigators, they are all touting precision and functional medicine in their individual practices. I did not look at every one of them, but the few I did all used testosterone in their practice for women.

Looks like it is taking longer to recruit 700,000 participants for the M. D. Anderson Cancer Center Study tilted "Evaluation of Association Between Testosterone Levels, Dementia, and Adverse Mental Health Outcomes"

Anticipated completion has been change from November 1, 2023 to November 30, 2025.

The Q1medicare website is very informative. A check of coverage for Corti and Acthar shows that on average Corti price is approx. $10,000 cheaper than Acthar. Additionally, it looks like coverage is currently concentrated along the east coast and some larger cities, showing much room for growth, over time.

Correction. When I initially searched Acthar on the Q1Medicare it did not produce result. I just tried it again and now shows that H.P. Acthar is covered by 0 PDPs and 80 MAPDs.

Apologies for any confusion.

Wow, at 7-20K per unit, that is a lot of zeros for a market opportunity. Current sales then have only captured a small fraction of this.

Silver, in 2015, when ANIP announced the deal for Corti they identified a patient population of approximately 4 million. I believe this represented the number of patients, who are refractory to standard of care treatments across all indications. Gouty Arthritis flares would represent 90,000 of the 4 million patients. Obviously working with Veeva has accelerated identifying potential patients who could benefit from Corti.

JMHO

Another great dig JTFM. This bodes very well for us given, from your findings, Medicare represented such a large portion of the category peak sales.

Another great find JTFM. I thought Acthar Gel had broader approved indications, but as your reference shows, we actually have more. I agree with you then that more should be said about our addressable market.

On a positive note, ANIP is chasing some of these indications now which bodes well then for continued category expansion. It is curious that "pulmonology' does not appear to be on the list of indications, but was the one of the first pilot programs they launched ahead of gouty arthritis. Must be a larger market opportunity which makes an even stronger bull case.

Corti prospects appears to get better. According to Q1Medicare.com the 2024 Medicare Part D Formulary. A search of Prescription Drug Across All Medicare Part D or Medicare Advantage Plans shows Cortrophin is on 2 PDPs (Prescription Drug Plans) and 88 MAPDs . According Healthline, MAPD plans are a popular type of Medicare Advantage plan because they cover multiple services. With a MAPD plan, you’re covered for medical services, hospital stays, prescription drugs, and more

Interestingly, Acthar is not listed as being covered.


Medicare Formulary 2024

According to the Drug Pricing Investigation Mallinckrodt—H.P. Acthar Gel in 2018, Medicare Part D plans spent more than $700 million on Acthar.