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Thanks auh2oman.
Thanks Dasgrunt. I missed that.
Novitium's website is up and LEVOCARNITINE is on it.
Thanks Dasgrunt, I see they have only two competitors. Oddly the Orange Book says it was approved in 2019 .
Orange Book
Agreed. I found it interesting that Deloite state the average cost to bring a drug to market in 2021 was $2.006 billion and forecast average peak sales for these drugs is $526 million/year (25.96% of the cost to get it to market).
Looking at Corti, ANIP is poised to deliver a much bigger return on investment. Arguably they spent less than $200 million for a Corti approval and are already reporting $12.6 million in quarterly revenue, a run rate at that level would give yearly sales of $50.4 million (25.2% of cost to get it acquired and approved). This ROI is only after 2 full quarters on the market.
Measuring-the-return-from-pharmaceutical-innovation-2021
Silvr, if the eventual goal was to move towards a smaller Libipatch, they must have what would be considered an unintentional excuse for not paying the patent maintenance fee. Noven's smaller patch patent expired June1, 2020 for non-payment. A patent that would not expire until March 14, 2032 plus whatever FDA patent term restoration.
Noven Patent
Silvr, apparently if they can prove that the delay in paying the maintenance fee was unintentional there is a possibility to reinstate the patents beyond two years. I feel that this is risky as there is no guaranty that the USPTO will agree that it was unintentional.
It is hard to believe that the patents were not sold, as it makes no sense for Antares to not pay the $3,700 maintenance fee and walk away from a potential royalty stream up to December 2033 (when FDA 5 year patent restoration is included)
I guess we will soon find out.
Good question Silvr. Upon reading amendment 6 to their Licence agreement date June 13, 2022, I found it interesting that Biosante or ANIP could have paid the maintenance fees and ANIP would own the patents. The following is key section from the agreement.
Silvr, something to watch for. As I understand it, companies have 2 years to apply to reinstate they patent by paying the oustanding patent fees. Antares' patent to treat HSDD expired January 6, 2021 for failure to pay the maintenance of $3,700. The patent regarding treatment of women in need, expired February 1, 2021, for the same reason. I expect to see an application for reinstatement as we approach to January 6, 2023.
Additionally, AbbVie should be releasing the male testosterone trial results shortly, as well. If results are consistent with Libigel regarding CV event reduction and risk, demand for female testosterone results will be even more pressing.
Thanks Silvr, I am certain they would have rather not have to sell the shares at this time.
Thanks ahh2oman. Hopefully, Investors agree.
Silvr, I believe PPS will track up to $50 (the price of the offering in November 2021) by the end of the year. I consider this more of a recovery, than a run. The real sustained long term run should start in 2023.
ANIP is two years into Lalwani's three year plan to transform ANIP into a sustainable growing biopharma. It will be very interesting to see what ANIP looks like at the end of 2023.
Hopefully they will actually post a pipeline of products under development including, but not limited to:
- Female testosterone
- Psilocybin
- Psilocyn
All of which have no approved equivalents listed in the Orange Book.
One STAT I really like about ANIP that investors should find impressive.
When comparing ANIP to the 107 other North American Pharma/Biotech/CDMO companies (Small Cap or Large) that have recorded Gross Profits in 2023.
On a per share basis:
In Q1 ANIP with $1.88 in GP/ share, ranked 37th out of 108 companies.
In Q2 ANIP with $2.37 in GP /share, ranked 32nd out of108 companies
In Q3 ANIP with $3.12 in GP/share, ranked 22nd out of 108 companies
This is trend, I see continuing quarter over quarter, as sales increase and margins increase simultaneously.
On November 11th when ANIP closed at $37.60, the PPS ranked 39 out of 108.
At Friday's close of $41.66, PPS ranked 35th out 108, and looks to be clawing it s way up the rankings
FYI, Incyte Corp. (INCY) currently ranks 22nd out of the group in PPS at $78.26
GLTA
I agree Easka. Year-end rebalancing?
Thanks Vishal 123 and Silvr. I agree on the dilution of our stake, but hopefully milestones payments and royalties will kick in someday.
That a weird premarket session. Bouncing between $33s and $39s.
Novitium picked up another approval for FLUOXETINE HYDROCHLORIDE.
November 9th approval
BB, ANIP maintained their guidance.
They also have a line on a couple of potential buyers. ANIP paid $18 million for Wellspring. They should be able to offset their closing cost with proceed from the sale of the plant.
It is all good.
Correction: Q2 Gross profits was $38.6 million making Q3 a 32% increase in Gross Profits.
I agree, it is painful. But we are in a much better position than the institutions that bought at $50 last November. When they want out, PPS will be driven well north of their entry price. As easy as it was driven down today, it can be just as easily driven up.
I also like that Gross Profits climbed from $35.3 million in Q2 to $50.9 million in Q3
a 44.3% increase.
Looking forward to Q4, I believe ANIP will announce start announcing positive GAAP EPS.
Silvr and BB, total volume 18,000 shares dropped it to below $33. Trying to shake shares from weak hands. It won last long.
Key quotes from conference call:
- "Our non-GAAP EBITDA this year has increased from $4.3 million in Q1 to $9.9 million in Q2 to $19.6 million in the third quarter of 2022."
- "The third quarter marked a return to positive cash flow from operations with $3.6 million of cash."
PPS will work its way north and should end the year strong as institutions rebalance for the New Year.
JMHO
Silver, the Libigel BLISS study started out with CV and Breast Cancer events as co-primary endpoints. Later CV became the only primary endpoint.
According to the January 2012 American Heart Journal article titled "A cardiovascular safety study of LibiGel (testosterone gel) in postmenopausal women with elevated cardiovascular risk and hypoactive sexual desire disorder", the Executive Committee had the ability to change, not only patient enrollment size, but protocols as well.
No doubt, the CV event rates they witnessed when compared to placebo justified dropping Breast Cancer from the primary endpoint.
I agree Silvr.
Silvr, I think it and other data might be used. The Draft you provide led to FAD putting out SubmittingDocuments Using Real-World Data and Real-World Evidence to FDA for Drug and Biological Products Guidance for Industry in September 2022.
Thanks Silvr. Just a matter of time. I am looking forward to the results of the 700,000 participant trial being conducted by M.D. Anderson Cancer Center, which should have just been completed this week.
Evaluation of Association Between Testosterone Levels, Dementia, and Adverse Mental Health Outcomes
Silvr, since statins appear to lower testosterone, and approx. 50% of the participants in the Libigel trial were on a cholesterol lowering drugs. It will be interesting to see how women on statins differed between those taking Libigel and those using the placebo.
Profitability next quarter would be great. Thanks Auh2oman.
It would definitely make for a more efficient partnership with ANIP.
Thanks Dasgrunt.
Silvr, another publication begging for Libigel's data.
Sounds good to me Silvr. Another potential use for Eluvogue.
Catty, it would all depend on how the deal was structured and if ANIP ponied up more that $2.5 million in further development.
If there is no upfront payment, or a full out sale of Libigel, we may be out of luck by the time the drug hits the market. We would only get 5% of the net revenue ANIP receives and this would run out June 19, 2023.
Basically, if it is deal that was in place when Dr Snabes went to AbbVie, we will probably get the CVR's paid out, as SIMES and other Board members would benefit from the CVR's being paid out. If, on the other hand, the deal was structured after the merger, we are likely out of luck.
Auh2oman, it looks like institutional investors are more comfortable with the spending to roll out Corti. If they come out with good growth, raising guidance and projections for corti sales, PPS should work its way back to the $50 offering from November 2021.
GLTA
Silvr, I was checking out patents and applications obtained from Cell Genesys, including those related to CG Oncology. It looks like ANIP only regained their security interest for these assets. The rights are still assigned to CG Oncology, Chinook ( Aduro) and Healthtree Inc..
Which still begs the question, "why was the security interest in these assets assigned to ANIP and not Truist Bank, with the new financing..
Thanks Silvr. It will be interesting to see how many indications will eventually get approved over time.
Based on "Clinical Trials Registration and Results Information Submission", it looks like an NDA filing for female testosterone is around the corner.
Extensions for Good Cause
Auh2oman, I agree the steady climb has been nice. I also nice to see that Short Interest has continue to head down ward.
So it appears s like they are sitting on the Following R&D pipeline products that we know of:
- Psilocybin, as you pointed out,
- Oral liquid composition of Terazosin for which they have a patent protection until 2041-02-01 and
- Female testosterone possibly heading toward an NDA filing (most likely by a partner Merck or AbbVie)
By the end of Lalwani's 3-year plan to transform to biopharmaceutical company, I believe they will have the cashflow to move to phase 2 and 3 clinical trials, without having to raise funds through dilution.
It will be interesting to see what PPS will be if they:
- Are able to expand Corti's prescriptions beyond what MNK was able to accomplish though their innovative approach of data.
- Announce a partnership for female testosterone and
- Post a proper R&D pipeline fully identifying their potential long term growth.
GLTA
BB, looks like sales are gaining traction. ANIP posted four new Clinical Account Executives positions this week.
Positions
BB, once ANIP starts growing Cash on Hand, without dilution, Investors will return to ANIP and PPS should surpass the high of $84 reach in 2019. Hopefully it happens soon.