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I agree Silvr, $10,000 is not much, in this case. The only thing that makes sense in not disclosing everything, by now, is that it is part of a larger announcement. Likely, involving one or more big pharma players. They control the clock.
Roche submitted results on November 22, 2023 and their already shows that Results Submitted. on their trial's webpage. However, the result are not visible yet, as it still undergoing a quality review.
Results submitted
It makes me wonder if the results were submitted on time, or if there are exceptions to posting the submitted results. If not, it may be more important for them to risk civil penalty for being non-compliant with the two year deadline, than to release the information, at this time. In any event, it has to be submitted 30 days after an FDA approval. Additionally, the results may not qualify for IJCME related publications, until submitted and peer reviewed.
Here is a good presentation on what guides NIH in posting trial results.
Updated Quality Control and Posting Procedures
It looks like at the very least, the results tab of the trial's web page should indicate that the results were submitted.
However, if they follow their own guidance we should see it by tomorrow, assuming it was submitted by the 2 year deadline.
Thanks Quarkspin.
Silvr, upon further examination, it looks like only 6 of Novitium's 15 HB1 applications in September were for new employees. Most were for continuation of employment for existing employees.
Very interesting podcast, Silvr. Early on, I wondered if Big Pharma had an interest in suppressing it's approval. Makes sense if it can negatively impact sales of existing drugs.
Happy Thanksgiving to all ANIPers.
Thanks Silvr.
Your guess is as good as mine. Hedge funds duking it out with the little time they have left to play with the stock at these prices.
Thanks for CGOO70 info.
I agree Silvr, hopefully, the trial review is completed and posted within NIH guidelines (by October 27, 2023), and the analyst have their act together to pin them down on Testosterone, their stake in CG Oncology and royalty potential, and Sovuna and Corti 1% competitive advantages.
Looks like they want to hit the ground running in Q1 when the expansion is completed at their NJ facility.
Two things worth considering.
Looking at the H1B Labor Condition Applications filed by Novitium on September 30th, it looks like they are meaningfully getting ready to expanding head count. Esjay Pharma is also expanding.
H1B
It is worth noting that Samy is selling the shares on behalf of Esjay Pharma LLC, which provides research and development and facilities consulting services to Novitium. We know they are conducting at least one Phase 3 Clinical trial on behalf of Novitium. Samy has a majority stake in the company. Esjay could very well be using the money to fund trials related to the patent portfolio Novitium and Nuray Chemicals have obtained.
Another study awaiting Testosterone approval. Though this article focusses on Estradiol, it looks like the best chance of reducing CV events may be linked to obtaining optimal Estradiol and Testosterone Levels. ANIP now has a generic Estradiol and it looks like testosterone is on deck.
Measurements of Postmenopausal Serum Estradiol Levels and Cardiovascular Events: A Systematic Review
Easka, it sounded like they are ready to sign a Letter of Intent and move to a full due diligence exercise. Hard to say if they were looking at assets or a company. If a deal involves an issuance of shares , it would make sense for ANIP to refrain from actively trying to elevate PPS, especially for tax purposes.
Silvr, I am certain that BlackRock see that ANIPs Gross Profits per share of $4.43 in Q3 was higher than NVS, ABBV, BMY, ZTS, NVO and was only $0.19 less than MRK. They also realize that ANIP is just starting a 20 + year growth run.
JMHO
Samy is selling and and BlackRock is buying. BlackRock picked up 367,870 share in Q3 and now own 2,500,970 shares, a 17.246% increase.
I heard that they have completed pre-due diligence on several candidates and moving towards execution. So I figure they are in the process of moving into the actual due diligence where they get to look under the hood and ensure deal makes sense. No idea if they a looking at drug(s) or a company.
I figure there is a reason for not giving color to Testosterone or any of their pipeline. We should find out soon about testosterone, as long as the results for the Clinical trials were submitted and NIH posts the results within their time guidelines.
With respect to share dilution. MVP and Ampersand were on board. so in the end if it benefits them it should benefit us.
I agree Silvr. And he dropped the ball on Corti IP question. He should have gone into the fact it is a DESI drug with a high barrier for a competitor to enter the market, Then, in addition we are seeking additional IP protection on the work we have done in bringing it back to market. Obviously he is not there to raise money or attract investors. More likely there to strike a deal. If they wanted investors they would show their real pipeline.
Funny it operates like a private company which is what MVP traditionally invests in.
Seeing the number of trials that will queued up, when an approved testosterone drug hits the market, I would not be surprised if a private pharma company is formed with ANIP and the larger pharma(s) having equity in the company. Where Revenue and and R&D expenses are shared. ANIP could end up with a smaller piece of a much bigger pie, especially if it involved two large pharma's such as AbbVie and Merck. It would explain why the activity has been buried.
JMHO
Thanks Silvr, good to see pellets were not recommended. Retrospective studies showed pellets reduced breast cancer. This will make Libigel trial data that more important.
Here's hoping. If they don't have news to release, I hope they practice on the way over the pond to effectively answer questions and avoid a repeat of the Earnings CC.
I think I figured out ANIP's MO for Branded drug development. Novitium and Nuray Chemicals R&D work on finding way to improve existing drugs. Obtain generic approval and get patents for new discovery, Then they file sNDA for the improve vesrion of an existing Branded or Generic drug.
Novitium first got approval of a Generic Hydroxychloroquine Sulfate Drug, once approved, they were later able to get approval for Sovuna (Trademarked) by applying for sNDA and showing how it differentiates form the the original. I imagine it is supported by some form of patent protection somewhere,
Novitium has also obtained a patent for a new and improved carglumic acid for which they have patent. I imagine they have SNDA for this one also.
Novitium also has patents for:
- Oral Liquid Composition Of Terazosin
- hydrochlorothiazide
According to the www.pharmacompass.com, I have seen a pattern where SS Pharma owned and founded by Samy make the FDA GDUFA application with API supplied by Nuray Chemicals. Looking
US Manufacturing
Looking at the Patent Centre
Nuray Chemicals has received patents for the following:
- Levoketoconazole
- Tafamidis
They have applied for patents applications for
- Pitolisant Hydrochloride
When looking at at these three drugs SS Pharma has submitted GDUFA fees for these drugs. Hard to believe they don't make to ANIP' s Product portfolio. Where ANIP will then work toward a sNDA . All have competitive advantages making FDA approvals more likely.
Silvr, unless this was intentional, they need a better IR personnel working on messaging. They could of easily stated that we are raising guidance, based on our core business not, the short term bumps we get from filling voids such as short term shortages, as Q2 guidance was for an average of $105.5 million in Revenue per remaining quarter (mid-guidance) to $117.6 million for Q4. Though we are not ready to give guidance for 2024, we feel confident enough in our revenue growth to invest in an expansion the New Jersey plant coming on line in Q1 2024. I bet that would have garnered a much different market reaction.
May be just a coincidence, but according to Merck's website, dating back to 2015, they have never presented at this conference before.
Merck Presenting
I agree, Silvr, they were awkwardly answering questions. I mean when the Truist Analyst asked about the shelf-life, of Corti 1-ml they could of answered it. It is not a secret, it is in the prescription guidelines and the opthamology position is on their website. Not announcing Sovuna, even in light of the way it traded the day after approval. It certainly looks like they are restricted in what they can say. Makes me wonder if there is a global deal for Sovuna in place. Especially in dealing with malaria in children. Maybe that is what the Jefferies presentation in London is about. I see Merck is presenting on the 16th the day after ANIP.
Thanks for the testosterone link. Another future trial for an approved female T.
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.