ANI Pharmaceuticals Inc (ANIP) Options

Thank you JTFM. The Tezruly situation is a very strange one. I think it is more than six months since it was approved.

Could be Silvr. Thanks.

On a side not National Drug Code protocol uses the distributor code on the label. When looking at the NDC database Inzirqo is listed under ANIP's label, but Tezruly code is no longer available as ANIP withdrew it s marketing

INzirqo

Tezruly shows the following:

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Tezruly

Looks to me like Tezruly with be distributed under a different label, whether sold or out licenced. While ANIP will distribute Inzirqo.

This could be another reason for no FDA approval yet for a female testosterone product. They made some substantive changes in the label for the men's product, including removing the black box warning based on the Traverse study results. I think this is good news for our eventual approval since it sets a precedent for no cardiac or stroke risk for men (other than higher blood pressure). I would hope our ten year study would provide comparable data for women.

New Testosterone Label

I found he host much more informed than previous hosts. Still no questions regrading Tezruly and Inzirqo.

Silvr my thought as well when I saw the PR.

Finally a good question from today's investor conference. The host called out the challenge of the low multiple for generics being applied to the rare disease business which is now half of the company, and whether they have considered doing anything about it. Nikhil's answer in brief was maybe.

I agree.

Good news. Thanks JTFM. It is very telling that they immediately announced this approval but not the others.

Corti pre-filled syringe got approved.

Approval

Can't argue with the lack of transparency. But, I am not concerned about the selling. I believe any insider buys before ANIP announces the approval of Tezruly and Inzirqo, would likely be considered insider trading.

It must form part of a larger announcement (e.g. partnership, spin off, etc..) otherwise they would have already announced them, as most companies do.

Personally, rather than acquire another company, I would like to see them start paying dividends next year, when cash flow is suppose accelerate quickly. Every time they buy something cashflow takes a hit for a little while. Once they start paying dividend, it will make any institutional tug of war, in relation PPS, less frustrating.

JMHO

Well, not enough transparency in my opinion . Questions : why insiders are just selling and never buying ?

Figures, we get a share price upgrade to 94 and the stock declines 4%. Looks like it is market wide for small caps.

Correction, it was their 4th patent for Corti.
US 11975047 B1
US 12102662 B1
US 12133831 B1
US 12233105 B1

Either M&A or rapid growth. Either way, it bodes well for ANIP.

Yes, most interesting. Gee, I wonder what insider information they are referring to?

The other thing I found interesting was in the discussion of leases:

We currently lease office space in Princeton, New Jersey, which is our commercial headquarters, which includes certain employees in our corporate, legal, human resources, business functions, and rare disease operations. The leases will expire between 2025 and 2028. We also entered into a new lease
agreement for office space in Princeton, New Jersey, which is expected to have a commencement date during 2025. The Princeton, New Jersey lease will have a remaining term of approximately 10 years.

It is confusing since they reference already occupying their "commercial headquarters". This is what is referred to on their website as the 500 Alexander Park location. However, they talk about entering into a new 10-yr lease at a Princeton location during 2025. Maybe the start of the new lease coincides with any M&A activity.

Silver, I found it interesting that the 10-k incudes exhibit 19.1 Insider Trading Policy. I haven't seen it in previous 10-k filings.

Possibly, I also wonder if the realignment of Brands with Rare Disease for revenue recognition is part any deal (future sale or spin off).

Just started reading the 10K and the first thing I noticed on page 3 is that these two trademarks were not listed as being owned by ANIP. Doesn't this solidify that they have been sold to someone else?

It will be back to 57 in no time. Congrats on another good quarter that will bring the PPS nowhere

Of course this will be one of the analyst questions today. Not.

Good earnings and still no news on Tezruly and Inzirqo

JTFM, Yes i do believe something is there in the future. I believe it will be a buyout and that is why I'm hanging in here. I have been long ANI for years now, and all the news that comes out is always good, constant approvals etc. Only problem is the PPS doesn't reflect the news. I don't think anything is there for the female testosterone, obviously i could be wrong, but i am hanging my hat on the generics they have out but mostly on Corti. I don't understand how shareholders are not calling for heads to roll as their investments have gone nowhere in years. They were going to sell the company a some years ago and i believe that is still in the cards. I can't stand hearing about the small amount of shares or the manipulation, just seems like the same old song and dance.

ANIP picked up a third patent for Corti today(Reference USPTO patent US 12233105 B1)

Bagel, I agree that the lack of growth in PPS and company secrecy is annoying. It has been going on for years, All we can do research information they can't hide and speculate on why they are withholding important info, and won't discuss it. With only 20 million shares this stock can be easily manipulated, as we have seen it climb over 20% with no news and drop the same way without any reason on many occasions. .

Though you do not voice it, you obviously believe there is something brewing that should benefit shareholders, and FOMO has kicked in, otherwise you would have sold and moved on.

Hopefully, Friday will put an end to the secrecy.

Good luck to all.

I've been hearing (manipulation to keep the share price low so institutional investors could buy more) for years. not months years. I think that's a load of BS. This is a lousy stock, that i am married to, I wish i got out a while ago. Seems like everything goes well for this company except the PPS. Female testosterone is the other crap I've been hearing for years, yet nothing. Secrets and hopes are what i find here. So annoying.

Many of the insider sales were registered earlier last year. Not tied to concerns regarding ANIP. The PPS drop is intentional manipulation to allow an institutional investor to pick up over 169,000 shares after hours yesterday. Could be hedge fund covering or the Cap Call picking up cheaper shares to be turned over later when the senior notes are converted

Woo hoo! Yet stock grants for everyone!

Congrats to all of us longs.....only 3 points away from the 1 year low! Lets Goooo!!!

Are you sure those are not the long term incentive stock grants that you saw the sec filings for last week?

Insiders keep selling and share price goes down.

Thanks Silver.

Maybe this is what we have been waiting for:

Launch of HRT Club

I think I mentioned this once before. It is significant that Besins is involved. Looks like they have a ready-made distribution network. Now they just need the product. Who the heck knows.

I thought the same (deja vu).

Thank you JTFM. For the desire domain, didn't the placebo beat the DHEA one (deja vu)? Regardless, it does not look like this one is going anywhere. Bummer.

Results from the Pill PLus trial.

Looks like only the desire domain has pvalue approaching 0.05.

Results

These drugs can be differentiated from the generics and the reference drug, which helps getting physician to prescribe them and eventually name recognition.

Sovuna does not appear to have patent protection, where as Tezruly and Inzirqo do.

Could be that they are being spun out, but it could also be part of big news to start a partnership. ANIP still has Tezruly on its product page, yet Inzirqo is not. However, the NIH National Library of Medicine list Inzirqo but not Tezruly.

Inzirqo

I guess we should be finding out soon.

Thanks JTFM. It is curious why these three have been branded where others were not. Spinning them out might be a reason, but, is it six months now since Tezruly was approved? Like you said, there better be a good deal for us coming out of this.

If ANIP's Sovuna goes for over $17 a tablet, I have been greatly underestimating the price for Inzirqo an Tezruly. This could get real interesting.

Sovuna Price

LOL, Genentech (Roche subsidiary) gets an original new form of a drug approved and they announce it the next day.

Genentech PR

All I can say is, ANIP 's reason for withholding info better have shareholder value as the driver.

Thanks Silvr.

Thank you JTFM. The trademarks are a good tell for who are the players.

Nice to see that we are green on a red day for the market. Hopefully, we can put the 50's behind us. Here is a bullish technical analysis I recently found:

Technical Analysis

SIlvr, fyi, neither Organon, Merck or ANIP have a trademark pending with the "sexual dysfunction" listed in the Good and Services.

However, AbbVie, Abbott Labs, Teva and Pfizer all do.

In treating HSDD alone, I would say Organ would be a good fit but when looking at most of the other potential indications for testosterone, I think Merk would be interested in the additional indications.

Thank you JTFM. The dates are very telling. Doesn't it make sense that it would get executed through their Organon spin off? Pill Plus would also have a home here.

It all makes sense now. Merck is almost definitely the partner.

ANIP announce the agreement to acquire Corti from Merck on September 21, 2015.

Corti announcement

The following day ANIP obtains Confidential Treatment Order extending to filings associated to Libigel up to March 31, 2020.


CT order to 2020

Looks like there was a gap between March 31, 2015 and September 22, 2015 where a CT order was not in place.

CT order expires March 31, 2015

Hard to argue that the Corti deal with Merck was not tied to Libigel.

Thanks Silvr, regarding the NYT story, it takes longer but you can read it through the source code. The text gets broken up by code for links etc... But it is readable.

Nothing in there regarding CV or BC benefits. It laments the lack of an FDA approve testosterone for women, while men have 31 options.

Here is an interesting excerpt They are intrigued by the fact that women have testosterone receptors all over the body — including the heart, brain, muscles and bones — which suggests that it is linked to the health of these organs, Dr. Davis said, but we aren’t sure yet why or how.

They say that testosterone is effective in approximately 50 % of women in treating HSDD . Mainly because there are so many other variables which may cause HSDD. For best results they recommend testosterone along with seeing a sex therapist. Interestingly they recommend obtaining a testosterone base line trying to see where the levels are in relation to when a patient was more sexually active. Maybe more related to the level of deviation as they age.

Personally, this may be true for HSDD, but I believe in the end getting to the average premenopausal range will drive the reduction in CV and BC events. If so, it could create a market in premenopausal women, as well.

They still advise against pellets and compounded testosterone, recommending a testosterone gel.

The New York Times has a recent article about female testosterone, but it is behind a paywall. Don't know if it is positive or negative.

Testosterone Therapy

More interestingly, Pfizer is now in the game. They are a big API supplier, but could there be something else?

Health Answers from Pfizer

Correction the dosage form for Inzirqo is powder for suspension , not oral solution.

Cool. Did not see that. Merck is a likely partner given the Cortrophin relationship. They have to be happy with the deal we struck with them on that.

There is sure a lot going on with this sleepy little company of ours.

Silvr, I find it interesting that in the "Case Parties" section near the top of the docket, they list Christina B. VAVALA of Polsinelli PC as an attorney but do not state who they represent. Could it be the silent partner? Maybe just a coincidence, but Polsinelli PC seem to have a good relationship with Merck having recently hired some of Merck's lawyers and represented Merck in both the Vioxx and Nuvaring litigations.