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I agree that their limited disclosure is frustrating. For one reason or another, they are a public company, still operating as if it was still a private company. It would be a good fit within their current infrastructure.
According United Therapeutic's 10-k filing:
According to the ANIP's 2022 Q2 filing
Thanks Silvr, I like your favorite part. I wrote the author and provided info for a potential follow up article, including Clinical trial results and patent applications.
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]
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.
Thanks Silvr
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).
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.
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.
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.
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:
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.
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.
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
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.
United Healthcare Pharmacy's Step Therapy Program differentiates FDA approved indications between Acthar and Corti.
If Acthar generated approx. $1.2 billion in sales while only FDA approved for the indication of Infantile Spasms and Multipole Sclerosis and are only suggested for other indications. How much larger can the market grow when Corti's FDA approved indications are added:
• Rheumatic disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: Psoriatic arthritis. Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance
therapy). Ankylosing spondylitis. Acute gouty arthritis.
• Collagen diseases: During an exacerbation or as maintenance therapy in selected cases of: Systemic lupus erythematosus. Systemic dermatomyositis (polymyositis).
• Dermatologic diseases: Severe erythema multiforme (Stevens-Johnson syndrome). Severe psoriasis. Allergic states: Atopic dermatitis. Serum sickness.
• Ophthalmic diseases: Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: Allergic conjunctivitis. Keratitis. Iritis and iridocyclitis. Diffuse posterior uveitis and choroiditis. Optic neuritis. Chorioretinitis. Anterior segment inflammation.
• Respiratory diseases: Symptomatic sarcoidosis.
• Edematous states: To induce a diuresis or a remission of proteinuria in the nephrotic syndrome without uremia of the idiopathic type or that due to lupus erythematosus.
• Nervous system: Acute exacerbations of multiple sclerosis.
Corti/Acthar Step Therapy
We know that Acute Gouty Flares is one revenue stream not included in Acthar's previous sales. Arguably even if Acute Gouty Arthritis flares affects 1% of the 9 million patients affected by Gout you are looking at an addressable market of $630 million, just for this indication. How of this market they capture remains to be seen.
It would be nice if Lalwani would frame the long term market addressable markets for Corti by indication, rather than have analyst believe that Acthar peak sales is the ceiling.
JMHO
Centene Covers 27.5 million managed care members across 50 states. They require a trial of Corti before trying Acthar for the following:
Multiple Sclerosis and Nephrotic Syndrome.
Acthar is give priority for Infantile spasms.
The following coverage does not provide a preference between Corti or Acthar: Rheumatic Disorders, Collagen, Dermatologic, Ophthalmic, Respiratory Diseases, Allergic States
This assumes Centene's subsidiaries are consistent with their subsidiary PA Health and Wellness.
Centene
PacificSource Community Solutions also gives preference to Corti over Acthar except for Infantile Spasm.
Easka, regarding Corti gout, the have no competition from Acthar with over 9 million patient affected by Gout and Corti 1ml selling for approx. $7,000 . If one only 0.5 % of this patient population is captured you are looking $315 million in revenue. Being able to be administered in the physician office, I think you will see uptake where standard of case is not working. We should see the proceeds from the Oakville plant in Q1 earnings. We may also see Sammy and Company get some earn out money.
I see guidance being raised in each quarter, even without acquiring a rare disease asset.
.
The BlueCross / BlueShield Federal Employee Program indicates Corti as preferred over Acthar except in Infantile Spasms
AmeriHealth Caritas District of Columbia is another plan that lists Corti as prefered over Acthar.
Corti coverage
Rhode Island's Neighborhood Health Plan is another Medicaid coverage that requires Corti be tried before Acthar be prescribed.
Criteria for approval