Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Easka, I agree it has been crazy.
Dasgrunt, could be multiple activities.
Thanks dasgrunt.
ANI PHARMACEUTICALS INC NEXT BIG UPTREND is interesting analysis of where the stock is trending.
Upward resistance is expected at $74.12 and $88.51
When it sustains PPS above $88.51 we should see a run towards $146.19
The next run should take it to $288.04
Then off in the distance a march towards $393.91.
Hopefully this is the year of the run
Thanks Silvr, I agree that it likely won't support health claims but it can help shape future "real world" trials for an approved drug on the market.
Acthar sales dropped from $140.9 million in 2022 Q4 to $82 million in 2023 Q1.
From Mallinckrodt's Earnings CC
Thanks auh2oman.
Silvr, it is hard to say what it means. Looks like they modified a number of corporate governance documents on May 3, 2023. Additionally, as it reads it looks like they have an Insider Trading Policy, however, it has not been posted to their website.
In this case, the Board had made the exception to grandfather Brown and let him stay on the Board. He appears to have voluntarily chosen to step down.
It looks like it is tied their shares (or at least some shares) being possibly being used as collateral for a loan. They did sell 200,000 shares in December due to liquidity issues. I wonder if they got pinched by rising interest rates.
As for the event we don't know if the event relates to the company MVP used the funds for, or if it relates to an event with the institution.
It may still be tied to Libigel, but there are other possibilities. If there is a few partnership regarding Libigel, with the seat being vacant it makes way for the partner to take an equity stake in ANIP and assume Brown's seat on the BOD.
I don't know about allowing the shorting of the stock. However, I doubt they would of allowed Brown to sit on future BOD meetings.
I agree the event, whatever it is, may still happen.
According to 8-K filing, ANIP's former Chairman of the Board and representative to ANIP's largest shareholder, MVP is leaving the BOD.
Thanks Silvr, that makes sense.
With only 17 million shares, and everything boiling below the surface, I would not be surprised if the goal is to turn ANIP into a large dividend generator. If so, than share price, to me, is less relevant and the can play all the games the like.
These are some of the potential future catalyst or key dates for ANIP as it relates to female testoterone
June 1-4, 2023 - National Lipid Association Scientific Sessions
June 20th, 2023 - CVRs expire.
September 7–10, 2023 - Hypertension Scientific Sessions in Boston
September 27 to 30, 2023 North American Menopause Society’s Annual Meeting in Philadelphia.
October 19 - 22, 2023 , San Diego, California AACR SPECIAL CONFERENCE: ADVANCES IN BREAST CANCER RESEARCH
Clinical trial Results due by October 27, 2023.
LOL! The offering for the merger and launch of Corti was priced at $50 institutions gobbled it up knowing they would be burning through in due to the launch. Now that ANIP both the merger and the Corti launch is complete and they are no longer burning cash, ANIP is trading below $43. Mnk is trading up almost as much as ANIP, most likely on the hopes of Acthar keeping pace with market expansion.
Hopefully, sanity returns by the end of the week.
Nice earnings report. Revenue up form last quarter even though Corti was lower than last quarter (as expected). What I like most is the gross profit margins continue to increase Q over Q. In the last call Lalwani stated the margins would stay around 61% as royalty revenue decrease would offset some of the gains made by sales of their products.
Silvr, we know that Novitium had three 505(b)(2) drugs for hypertension and oncology in the works when acquired. It looks like oral suspension Hhydrochlorothiazide was one, another being Terazosin Oral liquid which probably won't be as lucrative.
In 2020, 2,285,079 prescriptions of Terazosin were issued at average of 15.53 (generic drug). I figure it will likely generate peak sales of $60 million, unless the oral solution brings back patients who used nearly 6 million prescriptions in 2013. If so, you could be looking at $120 million a year in peak sales.
Not sure what the third drug will be unless it is Carglumic Acid which they have a patent for an easier to store version of Carbaglu.
Interestingly a study found that carglumic acid induced apoptosis in various cancer cells in vitro.
If Novitium brings an oral suspension hydrochlorothiazide (patent pending) to market. It should be huge.
Apparently 25% of hospitalized patients and 30%-40 % of those in nursing homes have trouble swallowing.
Evaluating Dysphagia
In 2020, 41,476,098 prescriptions of Hydrochlorothiazide were issued at average of $7.76 (generic drug) .
Arguably with patent protection to November 2042, ANIP could have a long run with this drug with peak sales exceeding $500 million.
GLTA on Monday
Easka, you may be right about them holding off until Monday. I don't know how big a market it is, but every little bit helps.
Novitium picked up an approval for the only generic for Pfizer's Celontin (Methsuximide).
Approval
Thanks Silvr,
That is quite impressive.
The presentation didn't add much from the earnings CC.
However, the slide presentation did make slight change from the previous presentation.
From Poised for Return to Strong Financial Growth
to
Ani Pharmaceuticals is Well Positioned to Drive Sustained Profitability.
Very good results indeed. Thanks Slvr.
Correction: The equity MVP gave up in ANIP to BPAX share holders is now valued at close to $165 million and at one time would have been worth over $370 million.
Silvr, to my knowledge, MVP has only one investment that they have held when it went public, ANIP. They have held it since the merger with BPAX. The equity they gave up in ANIP to BPAX share holders is now valued at close to $165 million and at one time would have been worth over $37 million. They were also a subsidiary of Wells Fargo at the time.
The way I see it, BPAX's initial patent application the reviewer assigned prior art to Dudley's application as it relates to CV event reduction, however Dudley's application was missing supportive data, which ANIP has in spades. Complicating matters was that Dudley's application was in a 50/50 sharing agreement with Besins Healthcare and Abbott/AbbVie.
In relation to Breast Cancer event reduction, ANIP has established prior art in their patent application prosecution on December 19, 2015.
AbbVie also now owns all the Intrinsa data.
Libigel safety and efficacy trial data is due to be posted October 27, 2023 or before.
Hard to believe there is not a master plan tying it all together to maximize profits and sustainability. I envision future patent application(s) to maximize patent coverage.
JMHO
Thanks Silvr. I find it hard to believe that MVP would not ensure that ANIP would from Libigel trial data. AbbVie's PPS got hit today as Humira's revenue replacement is now being questioned. If AbbVie is interested, They may want come out of the closet. I guess we will find some time this year.
I agree that some of their drugs will be sold. I am not certain if Art still has a relationship with AKORN.
Silvr, not sure if you posted about this, but Susan Davis is at again.
Evaluating Testosterone Therapy to Prevent Heart Failure in Women: The ETHEL Study.
Bagel123, retail investors only own about 13 %. We are at the mercy of the institutional games until they want it to climb. They will play with it and continue accumulating, while they can. Low volume makes it easy to control. I expect this to continue until big news comes out creating volume that makes it difficult to control PPS.
Thanks Silvr, Interesting information.
On April 18, 2023, Novitium was issued a patent regarding a tablet for oral suspension comprising of carglumic acid and its use. Set to expire June 14, 2042.
I was unable to post the link.
You can find the patent by search USPTO Public Patent Search and go to the Basic Search and enter 111628143 into the Quick Lookup box.
Thanks auh2oman.
Regarding - Lalwani's statement
Novitium picked up approval for Nitrofurantoin oral suspension.
Approval
It doesn't look like the sale of 2 million misoprostol tablets will be as meaningful as hoped.
California expects to pay $800,000 for the 2 million prescriptions.
Thanks Silvr.
Thanks dasgrunt.
I agree Silvr. Nice find Auh2oman.
Silvr, I like this line in Lalwani's letter.
Thanks Silvr. I think that changes by this fall.
FYI, Novitium has filed another patent application titled "Tablet for Oral Suspension" . The details have yet to be published.
Patent
Thanks Silvr, hard to tell what is in play. The CVR's were likely something that would of been actioned had the CV reduction patent been granted. As you stated, now waiting for them to expire benefits the majority of shareholders and is likely what is happening.
They now have to publish the Clinical Trial results by October 27, 2023. The results will likely be presented at the American Heart Association Scientific Session November 11 to 13. Registration opens July 2023, so I expect it would list ANIP or the partner to be scheduled.
Barron's lists ANIP as one of 20 stocks to own during the next bull market.
Crocs, United Airlines, and 18 Other Stocks for the Next Bull Market
Bagel, low PPS also affects insiders. I figure when ANIP starts generating serious cash, they will just start giving dividends, if PPS doesn't rise to appropriate levels. Insiders own more than 4.7 million shares.
With only 17.5 million shares, I am okay with that.
Silvr, a breakdown of the G&S for the trademark applications makes it look like they have more than one product in the pipe to be named.
Trademark for a
1 - pharmaceutical preparations for the treatment of oncological and cardiovascular diseases, hypertension, renal disorders and arthritis;
2 - Pharmaceutical preparations for the treatment of infectious diseases and auto-immune diseases,
With respect to terazosin, I have yet to find a use or trial where it was used for arthritis. If anything, arthritis is considered as a potential side effect.
Thanks Silvr. I wondered if the indications better suited testosterone or terazosin which they have patent protection until 2041.