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I agree Easka, and they have inputs that Lalawani would not commit to, but will likely materialize.
I find it interesting that they intentionally withhold Sovuna announcement. Avoid answering Les Sulewski's (Truist Securities) question about the shelf-life of Corti 1-ml vial (6 month vs 28 days) nothing about opthamology. Good for him at least trying. (Wish they had the nads to ask about testosterone.)
They guide towards lower Revenue and EPS lower than previously estimated.
Provide zero reason to counter EPS estimates for 2024 that estimate a reduction over 2023.
It looks they are intentionally trying to keep PPS low. Certainly something that could benefit a partner buying equity in ANIP.
No idea on earnings, as I not sure if they will some contingency payouts regarding Novitium. But my guess on revenue will be in between $125 to $130 million.
Thanks dasgrunt.
Jp2011, according to ANIP's last Corporate Presentation Acth category has grown 13 consecutive month. If this trend continues, it look like ANIP is capturing the majority of the growth. Obviously this is just a guess, but I believe we will see between $27 and $30 million in Corti sales. maybe more if the pulmonary sales started kicking it up a notch.
According to Mallinckrodt Earnings Release reported 2.9% drop in ACTHAR over last year. $122.1 million vs $125.7 million in Q3 2022.
Acthar® Gel (Repository Corticotropin Injection) Delivery Device Supplemental New Drug Application Accepted by U.S. Food and Drug Administration with a project launch in the second half of 2024.
One can hope. I would be interested in finding out more about them presenting in London.
GLTA
Novitium's Patent Application for Hydrochlorothiazide compositions was allowed today. Should be published once fee are paid.
Abstract
Disclosed herein is a powder for oral suspension and a reconstituted product thereof comprising highly pure hydrochlorothiazide, which is useful for treating hypertension and edema.
Plug in 18/053,197 in the Application box in the following link for more information. You can find more details under (Documents and Transactions)
Pantent Center
There was no information available under the patent term adjustment, yet. But it will expire on or after December 9, 2041 plus any patent term adjustment, if applicable.
Thank Silvr, I agree and see a boatload of clinical trials in the future, once approved.
Dasgrunt, it is interesting that ANIP topped the list. Don't know if they were the largest sponsor?
Not sure if it means anything either. But something to keep eye on.
Jp2011, analyst have raised the consensus earnings estimates over Q2's consensus estimates. This is line with ANIP raising guidance, they may however be using the low end in ANIP's guidance of $425 million. If so, then ANIP would only average $100.85 million over the next two quarters. Even using the top guidance of $445 million. ANIP would average $110.85 million for Q3 and Q4. Below the $116.5 million in revenue of Q2. They are also likely projecting Q3 will be lower than Q4, as consortiums will most likely make larger purchases in Q4 to take advantage of the lower price over 2024 prices.
I think it will be moot. As ANIP should easily beat estimates.
JMHO
Another potential future use for testosterone.
According to Correlation of serum circulating testosterone levels with stress urinary incontinence in postmenopausal women
Thanks Silvr.
Yes, the timing can only help.
Looks like a good fit.
I thought the same about the London location. Libigel and Rare Disease focus would be excellent. It looks like they are only doing 1on 1 at the Truist event and will be presenting at Jeffries and offering one one ones.
It may be a very busy week for them.
Silver, this is Acthar's storage instructions.
Silvr, ANIP announced today they will be attending the Jeffries Healthcare Conference in London UK. On November 15, 2023. Two days after the American Heart Association - Scientific Sessions are completed.
They will also attending Triust Securities Biospharma Symposium where they will have one on ones, only on November 9, 2023.
PR release
From the most recent Corti label update posted on the FDA site shows the 1ml vial has a 6 month shelf life vs the 28 day shelf life once the vial is first used.
I have been checking trial results daily too.
Looks like AbbVie large testosterone study has shown Efficacy of Testosterone Replacement Therapy in Correcting Anemia in Men With Hypogonadism.
I figured some of the additional benefits would start surfacing.
Hopefully female testosterone will have a similar benefit.
JAMA Network Article
Silvr, it looks like Achtar is currently drawn from larger vials. There has to be some expensive waste in this process. 1ml vials should be appealing to prescribers. It might also be easier to get the cost covered by insurance plans.
ANIP is hiring a Area Business Director in Ophthalmology looking to increase Corti sales. I imagine approval for the 1 ml dose will help.
Job opportunity
I agree Silvr, Androfemme has limited safety data.
Silvr, UK Parliament debated Menopause today. And the topic of the lack of an approved female testosterone drug came up.
The following are interesting excerpts from the debate:
Silvr, another piece to the puzzle. The Journal of the Endocrine Society published The Impact of Testosterone Therapy on Cardiovascular Risk among Post-Menopausal Women today.
I agree BB, it should be interesting.
That is interesting, Silvr. Should help with sales.
I may be reading more into this, but Guggenhiem has issued four consecutive buy ratings when ANIP hits $57.44, regardless of their price target. It appears that is price where Institutions work to move PPS back up.
Vamil Divan's Stock Ratings
Last rating was issued October 19th.
The Waved put out a trading analysis tutorial on YourTube for ANIP through 2024. Saying it is in a positive trend and recommends a $118 exit. Interesting to see what the exit becomes when Testosterone is publicly in play.
Analysis
BB, I am still assessing the stock.
BB, their phase 3 trial was unsuccessful.
Acasti Pharma's CaPre flunks late-stage study, shares down 60%
Another piece that will help in launching a female testosterone drug. The American College of Obstetricians and Gynecologists came out with a Clinical Consensus against using compounded hormonal therapy, which is endorsed by the American Society for Reproductive Medicine. This replaces the Committee opinion from August 2012.
Clinical Consensus.
According to the article:
Silvr, looks like the info regarding Pfizer was a standard template used in coding their webpage. It shows up being blurred for other pharma companies as well.
Fun while it lasted.
Very interesting Silvr. I agree that there appears to be so many twist and turns that, it would make a great book.
Thanks Silvr, I figured he would have a good cause for selling, especially going into the results coming out for Libigel.
Acasti is an interesting company. I got a kick out of one of their directors Dr. Kottayil. According to his bio on the site:
Silvr, according to ANIP filings SS Pharma LLC supplies Tafamidis:
Silvr, according to Pfizer's Q2 presentation The Vyndaquel family of products accounted for 6.1% of their revenue and grew revenue by 43% over the previous year.
The LOE for the US is 2024, but they have a Patent Term Extension pending which should take it to 2028. Whereas the EU LOE expires in 2026.
A generic is already approved for FoldRX Pharms. So I imagine they will want to get it approved in the EU in 2025, which gives them time to switch existing patients to the new version.
Q2 Presentation
Silvr, I would not be surprised if ANIP/Novitium got the rights to Nuray Chemicals IP related to Tafamidis, and have entered into a collaborative agreement with Pfizer to develop a replacement for a new and improved version of their Vyndamax® (Tafamidis), and Vyndaqel® (tafamidis meglumine) which starts to lose some patents and exclusivity December 2023 through 2024. This will allow Pfizer to switch their patients to the new drug which patent coverage extends to 2041.
Nuray Patent
Samy is the lead inventor for the patent.
Vyndaquel IP expiration
Vyndamax IP expration
FYI, Vyndaquel and Vyndamax accounted for $782 million in revenue for Pfizer in Q2.
JMHO