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Thanks Silvr
Thanks Silvr,
Thanks North.
From the NJE article
Thanks Silvr, it will be interesting to see who partners or acquires CG Oncology. According to the S-1/A filing they will have 55,282,511 outstanding shares when the IPO which set at $17/share is completed. This will give them a market cap of approx. $940 million as a starting point.
S-1/A
Though ANIP won't post a pipeline, according to Pharmacompass they have an extensive and diverse pipeline though it mostly relates to Arbutus Biopharma's pipeline:
ANIP Drug Development
Question is what is the link between Arbutus and ANIP?
Silvr, I believe Lalwani was referring to 2024 when saying there are no planned outsized product launches. Tamafidis (Pfizer's Vyndaquel family of drugs) is the blockbuster drug where Nuray Chemicals have patents to an improved version of the drug. Assuming ANIP gets the licencing rights, and unless they make deal with Pfizer, this likely won't be approved, using a 505 (b)(2) process, until 2026 or later. Pfizer has marketing exclusivity until May 3, 2026.
As for the market opportunity of oral solutions. I believe Pryzbyl indicated that Oral Vancomycin Hydrochloride would capture a 10% of the overall market. I imagine a similar percentage can be used for the drugs they are targeting. Since it will be branded and with no competition, it will be offered at a higher price to the existing drugs. Some of the drugs such have superior storage duration which can also increase market share.
In any event the pipeline should provide long-term above average growth.
ANIP's Oral solution patented pipeline protected to 2040 and beyond now includes:
- Tablet for oral suspension comprising carglumic acid
- A powder for oral suspension and a reconstituted product thereof comprising highly pure hydrochlorothiazide, which is useful for treating hypertension and edema.
- Novel stable oral liquid composition of Terazosin and its pharmaceutically acceptable salt which is useful for treating symptomatic benign prostatic hyperplasia (BPH) and hypertension.
- Stable Oral Suspensions Of Baclofen.
In addition will likely in-licence one or more patents from Nuray Chemicals which include:
- A process for the preparing levoketoconazole, its salts, solvates, and solid-state forms
- Process For Preparing Pitolisant Hydrochloride And Solid-state Forms Thereof
- Dosage Forms Of Tafamidis And Its Pharmaceutically Acceptable Salt Thereof
Nuray Chemicals is also working on a patent for :
- Novel solid forms of 6-carboxy-2-(3,5-dichlorophenyl)-benzoxazole of Formula (I) and it pharmaceutically acceptable salts thereof.
GLTA
Another addition to the Pipeline, if ANIP ever posts one.
ANIP picked up a patent for "STABLE ORAL SUSPENSIONS OF BACLOFEN" initially filed by Slayback LLC (Now Azzurity) and assigned to ANIP on August 14, 2023.
North, I haven't been able to find anything. But Noven did have a patent for a patch half the size Intrinsa and I see that to avoid irritation they recommend regularly changing the location of the patch.
It looks like the FDA first sends them a letter alerting them to the potential noncompliance with the requirement to submit clinical trial results. If the result are not submitted the FDA sends a Notice of Non-Compliance. Once this is done the Violation is posted on the affected clinical trial with the date of notice given and when the results were submitted.
As and example Ocugen was sent a letter July 21, 20221 and did not receive the Notice of Non-Compliance was sent April 15, 2022. They came into compliance on June 29, 2022. It does not look any fines were issued. Though they were subject to potential fines.
NOTICE OF NONCOMPLIANCE ISSUED PURSUANT TO 42 U.S.C. 282(j)(5)(C)(ii)
Clinical Trial
It looks like the FDA is more concerned about compliance than fines, as only five companies have received Notice of Non-Compliance.
ClinicalTrials.gov - Notices of Noncompliance and Civil Money Penalty Action
Silvr, all the secrecy surrounding female testosterone might be lifted tomorrow. According to AbbVie's website:
Silvr, Emergex's June 6, 2023 media release is the first time they use the DengueTcP trademark and state that an application for the trademark has been submitted. I imagine it won't get published for another couple of months, assuming everything was properly submitted.
I agree the disclaimer would allow them to publish some of the royalty pipeline. There has to be larger reason for not disclosing anything. CG oncology does not disclose the licensing agreement with ANIP, ANIP does not disclose any of its legacy licence agreements.
Thanks Silvr, I like Emergex’s platform's potential to provide cross-reactive immunity to a range of existing or emerging viral and intracellular pathogens, beyond Dengue Fever.
It would be nice if ANIP eventually list A Royalty Portfolio, similar to that provided by Ligand Pharmaceuticals.
Ligand
Novitium's powder for oral suspension of Hydrochlorothiazide was patented yesterday. Patent expires November 7, 2042.
Patent
Silvr, from the S1.
Excellent Silvr, clarity on ownership and licensing would be great.
Another reason to get a female testosterone drug to market to help justify larger trials. Causal effects of genetically predicted testosterone on Alzheimer’s disease: a two-sample mendelian randomization study had the following conclusion:
ANI is now posting six Clinical Account Executive - Pulmonology positions. on their Commercial Positions web page. Looks like their expanding Corti -pulmonology. Wonder if this group will be leveraged for incoming acquisition or partnership as well.
Pulmonology Positions
I concur BB. Same to you and your family BB and the rest of the message board members .
Happy Holidays to all, or Happy Festivus for the rest of us.
Correction: These two analyst are estimating revenue growth in from 2024 to 2025, so it looks like revenue from sale of drugs, not selling off Testosterone.
According to www.wallstreetzen.com, two Wall Street analysts are forecasting ANIP's revenue for 2024 to be $10,112,804,819, with the lowest ANIP revenue forecast at $9,994,573,609[/b], and the highest ANIP revenue forecast at $10,231,036,028 and ANIP to generate $10,416,813,330 in revenue in 2025, with the lowest revenue forecast at $9,897,904,012 and the highest revenue forecast at $10,935,722,649.
Revenue Forecast
No idea as to the accuracy of this info. However, if accurate, the analysts are definitely factoring in Testosterone approval. It sems high to me, unless, they are factoring in global approvals for HSDD, CV and Breast Cancer risk reduction, or, ANIP selling off it's stake in female testosterone at between $9 and $10 billion in 2025.
GLTA
Thanks Silvr
Thanks Silvr.
Easka, to the best of my knowledge, no analyst has publicly asked or documented questions or answers regarding female testosterone. I believe Silvr or another member of this Board asked for an update at a shareholder's meeting and they punted the question down the road. That wasn't their focus at that time., or something to that effect.
Silver, I wondered that as well, But Robert Daugherty has an impressive CV. Which leads me to believe he sees what we see. Now we may have helped him get there. But he seem to validate our fundings.
This is his Bio
Thanks Quarkspin, I Iike the following:
Analysts' revenue forecast of $480 million for 2024 excludes recent product launches and assigns no value to its female testosterone offering, a rapidly expanding market segment.
I have added the link.
Double The Returns: 3 Top Stock Picks For 2024
Thanks again.
Thanks Silvr.
Silvr. I asked when we could expect a pipeline presentation, including CG0070 and Female testosterone .
Upon examining ANIP's Open Commercial Positions, mostly posted with the last two weeks, it looks like ANIP must be planning for a large increase in work. Hard to tell if the Associate Director/Director positions is one Associate director and one Director or a position with potential growth to Director level. In any event looks like a number of areas expanding to handle increased workload.
Associate Director/Director, Strategic Development & Advocacy (Pulmonology)
Associate Director/Director – Commercial Training
Associate Director/Director, Marketing
Associate Director/Sr. Manager, Incentive Compensation
Sr. Manager/Associate Director, Patient Support Operations
Associate Director/Director, Strategic Development & Advocacy
Positions
Acquisition? Corti 1ml Vial and Sovuna? Female testosterone? or the combination of all of them.
Thanks Silvr. I wish we could have seen agreement, as CG Oncology out-lic enced to Kissei Pharmaceuticals for Japan and pother Asian Countries.
PRress Release
Looks like analyst are sandbagging estimates. In Seeking Alpha, I compared the Revenue estimates for 2025 by analyst vs the Revenue Growth (FWD). It is the estimated compounded annual growth from 2021 to 2025. Their analytics show an estimated growth rate of 32.26%, which would give ANIP $661.25 million in revenue for 2025 vs the analysts estimate of $537.18 million.
That works out to $34.62 in revenue per share in 2025 (less dilution). In 2021 revenue per share was $17.16.
It will only get better when revenue for Corti 1ml, Sovuna, Libigel, and a royalty stream/milestone payments from CG Oncology are calculated.
GLTA
Novitium paid their patent fee today for HYDROCHLOROTHIAZIDE COMPOSITIONS. It should be published as a patented case in approximately three weeks, with a patent term adjustment, if they qualify.
Patent
Excellent news Silvr, I will definitely reach out to them.
Finally, Piper Sandler was a decent presentation with good probing questions from the host. Though they did not give away any secrets, Lalwani indicated the following:
- They have M&A candidates in their sights for rare disease expansion. They could go up to 3x leveraging with a mix of stock similar to the Novitium deal for the right deal. Ideally within they established rare disease sales force Rhuematology, Nephrology and Pulmonology.
- Though no numbers given the 1ml vial used for acute gouty arthritis flares is not considered a rare disease, however they will start with their sales team that is focused on Rheumatology and expand as warranted.
- They see the Acth market expanding beyond the $1.2 billion that it peaked at, with a patient base greater than when it peaked.
- They expect to launch around 15 generic products in 2024 with the addressable markets increasing in size to maintain growth as company revenues continue to grow. And expect to file 12 to 18 ANDA's a year increasing in size moving outward mostly organically, with a few tuck in drugs.
- Shortages are being caused by three factors, FDA inspecting ex-US facilities and finding issues even when corrected, it takes time for the FDA to conduct the follow up inspection. Some generic companies are in financial trouble creating shortages. Lalwani expect to see this trend continuing in 2024. ANIP with a US manufacturing base an API readily available, is also nimble enough to quickly meet demands and is being recognized for this capability.
I would not be surprised to Piper Sandler initiate coverage.
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.