ANI Pharmaceuticals Inc (ANIP) Quote

This company goes against every norm. Something is definitely cooking.

Lalwani is now selling 33,481 shares, knowing full well that he could announce Tezruly approval and provide info on the other NDAs including PDUFA dates which would drive price up PPS, leading to less shares having to be sold.

The deal must be good enough for him to feel comfortable in selling these shares at a discount.

SEC filing

There does not appear to be many extraordinary circumstances that apply. From what I can tell there is a high burden on ANIP to justify the FDA not disclosing the approval. I see that Abbott cited extraordinary circumstances in fighting disclosure safety and efficacy data regarding Humira and lost their argument.

Thanks JTFM. It would have to be a pretty extraordinary circumstance to hold off announcing approval and taking it to market. I guess it is not much different than having one approved (Tezruly) and then not telling anyone about it.

Hi Everyone, is there any recommendations of a stock to keep an eye on. I value everyone's opinion on this board (which has never failed me 😜). not sophisticated enough myself, that is why I need help, thanks.

I just found out that it is possible that the partnered drug may already be approved.

According to PART 314—APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG

§ 314.430 Availability for public disclosure of data and information in an application or abbreviated application.

(e) After FDA sends an approval letter to the applicant, the following data and information in the application or abbreviated application are immediately available for public disclosure, unless the applicant shows that extraordinary circumstances exist. A list of approved applications and abbreviated applications, entitled “Approved Drug Products with Therapeutic Equivalence Evaluations,” is available from the Government Printing Office, Washington, DC 20402. This list is updated monthly.

Code of Federal Regulations

Still trying to figure out what constitutes an extraordinary circumstance which prevents the FDA from posting approvals .

129,652 SHARES FOR $58.64 at 4:37 pm. Hefty block

yes, that will certainly happen since the PR is not confined to post-menopause only.

Good point. Off label use, until approved at some time on the future?

Thanks JTFM. Hard to beat Oprah. However, won't any FDA approval be done for post-menopausal women?

Word is spreading. Oprah daily is writing about it.

Testosterone Is a Female Hormone, Too - And for women in perimenopause, it could be an essential missing piece in the hormone-replacement puzzle.

Article

With over 50% of revenue coming from rare diseases assets in 2025, ANIP is on track to generate at least $800 million in revenue in 2025. This excludes any revenue for Tezruly or the other two NDAs. Analysts consensus is $718.47 million in revenue for 2025 and reaching $802.27 million in 2027.

It will be real interesting if Lalwani was including revenue from Tezruly in his assertion that 50% of revenue would come from rare disease assets.

Good point regarding the need for an approved product to gain insurance coverage.

Good find JTFM. The PR engine is on overdrive right now with multiple news outlets and podcasts talking about its use for women. All religiously say there is no FDA approved product, so hopefully this changes soon. For one of my other stocks, there was a point made that the current FDA administration is looking to get approvals out the door, so maybe we finally see it happen.

Regardless, here is a current policy from BCBS of Texas. As of the new year, they do not reimburse for testosterone testing and treatment for women. As I think about it, this is another advantage of building a following for the product since this will help convince health plans to cover it once FDA approval occurs.

Testosterone Policy

Another reason to get female testosterone approved. According to The molecular mechanisms of steroid hormone effects on cognitive function

Objective
There is a lack of information on the molecular mechanisms by which steroid hormones (testosterone, estrogen, and progesterone) regulate cognitive impairment. Thus, we aimed to identify the protective effects of steroid hormones on cognitive function.

Methods
We analyzed the literature on the molecular mechanisms, biological activities, physicochemical properties, and pharmacokinetics of steroid hormones.

Results
Steroid hormones can protect against cognitive impairment by regulating key genes (INS, TNF, STAT3, ESR1). Specific microRNAs, namely hsa-miR-335-5p, hsa-miR-16-5p, and hsa-miR-26b-5p, along with transcription factors NFKB1, PPARG, NR3C1, GATA2, EGR1, ATF3, and CEBPA, play a significant role in this protective mechanism. The involvement in cognitive processes, regulation of phosphorylation, neuronal apoptosis, and signaling pathways related to Alzheimer's disease significantly influence the protein-protein interaction network underlying these effects. Additionally, steroid hormones exhibit anti-hypercholesterolemic properties, anti-inflammatory activity, antitoxic properties, and function as inhibitors of acetylcholine neuromuscular transmission. They also hold promise as therapeutic agents for the treatment of dementia. Promising therapeutic interventions for cognitive impairment include the use of miRNA sponges targeting hsa-miR-16-5p, along with the administration of capsaicin, minocycline, dopamine, sertraline, and minaprine. The gut microbiota species Lactobacillus amylovorus, Paraprevotella clara, Libanicoccus massiliensis, Prevotella oris, Turicibacter sanguinis, and Dubosiella newyorkensis were identified as significant contributors to cognitive impairment and altered levels of steroid hormones.

Conclusion
Steroid hormones are promising compounds for improving cognitive function. Further research is needed to validate these findings through focused investigations into apoptosis, regulation of neuronal cell death, miRNA sponges, interactions with gut microbiota, and the potential efficacy of pharmaceutical agents.

Scratch that. The shares were sold at the end of September. The reporting Is just now catching up.

As I was browsing the ANIP website, I came across some SEC filings that I had not seen (Schwab moved everyone to ThinkorSwim and I am still learning how to use it). There was a 13G filing made by Rubric Capital on 11/13 to acknowledge that their position was reduced below 5% (to 0.3%). That's around a million shares or so. I don't think it is a coincidence then that that is when we saw the big decline start. I read that the Rubric founder is starting up a new fund so maybe this was for that purpose. Who knows what other motives there might have been. Regardless, I am sure that it got the algorithms working against us.

There were also couple of executive sales which never help the cause.

North and Silvr. I find it interesting that Lalwani sated that over 50% of revenue will come from their Rare Disease division. It sounds like they intend to out-licence Tezruly. Which would explain why they have not launched it. An up front payment plus royalties could give them additional cash for the future rare disease acquisition(s) they spoke about at the Guggenheim conference. If that is the case then you will likely see them also include the NDA filed Q1 2024 in the deal.

But who really knows with this unorthodox group.

Yes, it does North. Nikhil must be there for other reasons since this slide deck is nothing new. I was hoping we would get some news, but not expecting any. It is strange that the "Corporate Presentation" on the website is still dated for June, but there is a Jefferies deck right next to it from November. Normally, they would be the same. Also, no mention of Tezruly or pending NDAs.

I hope we do get some news soon, because there is a long dry spell now before Q4 and annual results get posted. That's a lot of time for the manipulation to continue. I thought we would break out several weeks back, but here we are. I am not sure what it is going to take with the kind of performance that is already being delivered and the high analyst price targets. There continue to be the wildcards of female testosterone and the CGON license revenue.

GLTA

4 hours after 8-K, and ANIP's "puzzlement" continues, eh? Nice slides.

8k filing, slides available today from Schwab.

Not sure about Credit Suisse's involvement, but ANIP legal team has subpoenaed a number of witnesses, including JP Morgan (lead book runner for their IPO), Pfizer and a number of others. See CG Oncology's reluctance to be deposed, it is possible more info is being learned, leading to the later subpoenas.

Personally, I think CG Oncology is playing a game of Russian Roulette, with this case. If their breach causes the negation of the deal and ANIP ends up owning the IND. CG Oncology will have to pay more than the 5% in global sales, to regain the IND. ANIP has nothing to lose and everything to gain.

I believe the reason CG Oncology does not put much about the case in their filings, is that the deal with Biosante/ANIP does not appear to have been disclosed in their IPO, and stating their position that ANIP was no longer entitled to royalties. They could not only be looking at litigation from ANIP but the IPO investors for withholding the risk.

Lilwani recently stated that he expected the case to go to trial some time in 2025, Not sure if this judges declaration will impact that.

Thanks auh2oman. It is interesting that they are bringing in Credit Suisse late in the process. Perhaps something was learned in other depositions. Regardless, I like how our team is on offense.

From BioSpace Back in the Day ...

Here's an excerpt:

BioSante Pharmaceuticals, Inc. Sells Virus Technology to Cold Genesys for $95,000; Also Eligible for Milestone Payments
November 17, 2010 | 3 min read

LINCOLNSHIRE, Ill., Nov 17, 2010 (BUSINESS WIRE) -- BioSante Pharmaceuticals, Inc. /quotes/comstock/15*!bpax/quotes/nls/bpax (BPAX 1.48, +0.02, +1.36%) , today announced it sold to Cold Genesys, Inc. exclusive, worldwide rights to develop and commercialize its oncolytic virus technology. The technology includes CG0070, a replication-competent adenovirus that has completed a Phase I clinical trial for treatment of superficial bladder cancer. In exchange for the technology, BioSante received a 19.9 percent ownership position in Cold Genesys and a $95,000 upfront cash payment and is eligible to receive future milestone and royalty payments

.https://www.biospace.com/biosante-pharmaceuticals-inc-sells-virus-technology-to-b-cold-genesys-b-for-95-000-also-eligible-for-milestone-payments

Found this. Credit Suisse was involved in the below transaction with Cell Genesys.

SOUTH SAN FRANCISCO, Calif., April 11 /PRNewswire-FirstCall/ -- Cell Genesys, Inc. today announced that the Company has entered into definitive agreements with selected institutional investors to sell 10.8 million shares of its common stock and warrants to purchase 2.2 million shares of its common stock through a registered direct offering for gross proceeds of $60 million, before deducting offering fees and expenses. Credit Suisse Securities (USA) LLC acted as lead placement agent for the offering and Needham & Company, LLC, Canaccord Adams Inc. and Cantor Fitzgerald & Co. acted as co-placement agents.

The Company intends to use the net proceeds from this offering to fund development of its product candidates, including ongoing Phase 3 trials of its lead product, GVAX immunotherapy for prostate cancer, as well as for general corporate purposes.

The shares and warrants are being offered pursuant to the Company’s effective shelf registration statement previously filed with the Securities and Exchange Commission. The shares and warrants may be offered only by means of a prospectus. The shares of common stock and warrants are immediately separable and will be issued separately. The five-year warrants will not be exercisable prior to six months after issuance. The closing of the offering is expected to take place on April 16, 2007, subject to satisfaction of customary closing conditions.

Additional information and details with respect to the offering will be included in a final prospectus supplement and related prospectus that will be filed with the SEC prior to closing. When available, copies of the final prospectus supplement and accompanying prospectus relating to this offering may be obtained from Credit Suisse Securities (USA) LLC, Prospectus Department, One Madison Avenue, New York, New York 10010 (1-800-221-1037).

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state.

About Cell Genesys

Cell Genesys is focused on the development and commercialization of novel biological therapies for patients with cancer. The company is currently pursuing two clinical stage product platforms -- GVAX(TM) cancer immunotherapies and oncolytic virus therapies. Ongoing clinical trials include Phase 3 trials of GVAX immunotherapy for prostate cancer, Phase 2 trials of GVAX immunotherapies for pancreatic cancer and for leukemia, and a Phase 1 trial of CG0070 oncolytic virus therapy for bladder cancer. Cell Genesys continues to hold an equity interest in its former subsidiary, Ceregene, Inc., which is developing gene therapies for neurodegenerative disorders. Cell Genesys is headquartered in South San Francisco, CA and has its principal manufacturing operation in Hayward, CA. For additional information, please visit the company’s website at www.cellgenesys.com.

Yikes, make it stop. Lots of sales at the bid on low volume, so sure looks like manipulation.

Something is happening on the CGON lawsuit front. There were confidential letters sent by each party to the judge this past week, and now the judge put a note out saying he plans to make something public. Then, there is another subpoena from us to Credit Suisse. I can't find any reference to where they were involved with CGON. JTFM, any idea why they are being subpoenaed?

Roddy, aside from market jitter with Trump cabinet picks, I believe the catalyst is institutional greed. It does not take a lot of volume to get ANIP to bump down or up in PPS. If ANIP had announced what the NDAs were for and who paid for one of the NDA filing. they likely could be buying. As it stands any insider buys might be considered insider trading, Especially if, when announced the PPS rises considerably.

JMHO

True! But there has to be a catalyst for such a negative share price performance after the positive quarterly results that may be only a few insiders know about. I do not see any insiders buying . Why? This drop is insane. I really hope I am wrong,

Goldman Sachs picked up 626,110 shares last quarter, for a total of 716,069 shares. How many small cap pharma stock have BlackRock, Vanguard and Goldman Sachs as their top three institutional investors and JP Morgan sitting as their 8th largest institutional investor.

Thanks Silvr, looks like a good fit.

Uggh, horrible week behind a great quarter. This too shall soon pass.

Here's a possibility for next week's Jefferies London conference. I own Sangamo. They purchased Ceregene's assets many years ago and have two late stage gene therapy products. One is for Hemophilia A and is partnered with Pfizer. The other is for Fabry Disease. They just got a very favorable ruling from the FDA which eliminates the need for further trials and cuts three years off the development timeline. Turns out they will also be presenting in London.. Fabry Disease is a a rare nephrology disease. The product is not partnered and there is discussion about whether it will be licensed out or commercialized by the company itself. They don't have the rare disease infrastructure to pull this off, but we do.

True to course, nothing will probably happen next week.

From what I have been reading, picking RFK Jr may have caused many of the pharma stocks to drop today.

Actually is another nightmare day … roughly - 5% compared yesterday.

Disregard, it looks like a glitch in the system at SA, the volume and previous close were out of synch as well. Oh well!

If you look at Seeking Alpha now you won't see that trade. but this is what I saw



More manipulation.

Seeking Alpha shows that ANIP traded as high as $97.92 today.

I can't tell from what exchange it occurred, if accurate, the partnered drug may have gotten the nod from the FDA. Word should filter out soon enough.

When mapped out on the chart, it was easy to time the institutional manipulation to certain events. Shouldn't be much longer before the trend reverses.

Great chart JTFM. It fully captures my current state of mind on the stock, Looking for the wind to change.

Institutions now own 109.14% of the float. This does not include us retail investors.

PPS has to remain above $96 for the notes to convert prior to 2029. Or , a certain event(s) where they are made whole.

Should be a good ride over the next year.

Maybe recently North, but with all due respect the link to the chart I have attached comparing ANIP to the iShares US Pharmaceutical ETF and Invesco Pharmaceuticals EFT shows the institutional manipulation related to ANIP's actions.


ANIP 1-year return comparison

You can see that in February when ANIP announced good earnings and overcoming the concerns of a significant drop from earlier quarters, as ANIP was not expected to pick up the gains from filling as many drug shortage request, the stock jumped upwards and remained there almost doubling the return of the two ETFs, until May.

After ANIP beat market earning estimates for Q1 in May, ANIP presented at conferences, shortly after the PPS drove down showing lower returns than the other two ETFs once the institutions had complete their accumulation the PPS started to rise and the returns had climbed above the two ETF and likely would of continued but June 24th, ANIP announced the acquisition of Alimera which brought ANIPs return in line with the ETF's. In August on the heals of another good earning and raised guidance, ANIP had big drop which has kept ANIP's return over the last year at about half of the two ETFs. I attribute this to the Senior Note Offering and Capped Call which were announced the following day.

Now if ANIP wanted to show a 1 yr return at a level significantly above the two ETFs, they could show their cards regarding NDAs and patents, naming their partner or provide revenue projections for 2025 and 2026, instead of the vague references to growth parsed out, that we have to analyze and guess to get an idea of their potential. Until then, it is easy for the institutions to keep manipulating PPS downward. The reverse will occur one day and we should benefit from he ride up.

JMHO

The market is jumping up or falling down in terms of individual company share prices over the last 3-6 months. Nothing in our portfolio has stayed a constant course up or down in share price. Huge volatility lately attributed to election results, hurricanes, fires, Federal Reserve, interest rates, company earnings etc. Even NVDA is waffling like the rest, pending earnings and more news re AI developments next week. ANIP is not different in unpredictable daily share price.

It makes sense. But why investors are not buying a stock that is over delivering , growing nicely sales and profit , and rising guidance ? Manipulation is stronger than everything else !!!???

It makes sense. But why investors are not buying a stock that is over delivering , growing nicely sales and profit , and rising guidance ? Manipulation is stronger than everything else !!!???

I figure it is the effect of the Senior Notes holders and the Cap calls being in play.

Sone note holder shorted the stock and took the cash to minimize their out of pocket expense for the loan, knowing they will be able to convert the notes to cover their short position. While institutions covering the cap call are incentivized to keep PPS down. We appear to be in limbo until the next big move. If ANIP is getting a partner to take an equity stake in it, the lower price benefits the partner.

JMHO

Yes , share price really frustrating. No matter what business results they post price goes up for 2 day and then drop back . To me this is a weird , but there must be a reason and soon or later we will find out

Well, for sure they will be visiting the Alimera facility just outside of London. I hope it is somehow connected to a major pharmaceutical deal. The share price action has been frustrating. It was about to break out of its long downward channel, but then, sure enough, it gets brought right back down. With price targets of above $80 and strong Q3 results, perhaps there is an ulterior motive to keep the price where it is.

GLTA

Maybe just a coincidence but Astrazeneca presents at Jefferies in London on the 20th as well, The they are scheduled to present is not available.

I figure any phase 3 deal would be after the readout, but before an NDA submission. Unless, as you said the, cash will be flowing freely. I expect they will have both a partner and serious cash flow.

Another thought, it is "risk on" to even consider taking on a phase 3 product. Maybe they are so bullish since they will have either a partner or lots of cash flow to work with from the new products. Again, he made special emphasis about this.

Yes, that is what I was thinking too. He stopped the interviewer on the call to talk about their M&A ambitions. My first reaction was with what money, but this would be great. Of course a dividend would not be so bad either since they took our CVR away.


GLTA, who knows where this mystery novel ends. I agree with JTFM, the next chapter finishes at the London conference.

It would explain why they are already talking additional acquisition(s).