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.
Interesting possibility, but I think North may be onto something about the possibility of ANIP being part of a multi-player deal of some sort such as the Amylin acquisition by BMY and AZN. I found it interesting that Walsh sat on Amylin's BOD during the deal and would not be surprised if another similar deal deal gets announced for ANIP.
Biosante facing delisting on June 4, 2012 executed a 1:6 reverse split it still kept the authorized shares total at 200,000,000.
On July 18, 2013, ANIP executed another 1:6 reverse split which left ANIP with only 33,333,334 authorized shares. The only way this makes sense is if there was a deal on the table and ANIP only need shares to help with business development for finite period of time.. The end of time appears to be approaching, as almost all of ANIP's authorized shares are now accounted for.
Walsh was not in the picture back then. and the initial deal may have gotten scuttled with concerns over Testosterone CV safety. However, ANIP's patent application for CV and Breast Cancer risk reduction were halted in 2018, when informed that they had to file each risk reduction in separate patents. Such a filing would have exposed the fact that work had continued on Libigel and who the partner would of been. Though I could be wrong, I personally believe AbbVie to still be one of the partners and with the addition of Elizabeth Powell, I would not be surprised if Merck were the other partner.
JMHO
Thanks Silvr
Roddy4, I agree with Silvr, In my opinion, something is definitely up. Though PPS activity has been frustrating, it doe snot necessarily mean something is wrong. So few shares make this company's PPS very easy to manipulate. It has gone up quickly without news in the past, as well.
If ANIP does not get bough out immediately, it appears that ANIP expects to get bought at a future date, or ANIP will be so flush with cash that they have no need to issue shares for future business development.
As Silvr stated, you have to make your own risk/reward assessment. I have been in since 2011 and seeing the testosterone discovery to the end. Hopefully we won't have to wait much longer.
GLTA
Good point, Silvr.
Further evidence that ANIP is preparing to be bought out. On July 29. 2024, Novitium Pharma (ANIP subsidiary) gained NDA approval for Tezruly (oral solution of terazosin) and was authorized to market it August 1, 2024. ANIP never announced the approval or launched the drug. According to the Orange Book, Tezruly's marketing status has since been discontinued and on September 24, 2024 ANIP submitted related patent information expiring January 18, 2042.
Looks like the acquiring company will launch the first approved oral solution of an alpha-1 blocker in the world.
https://www.accessdata.fda.gov/scripts/cder/ob/results_product.cfm?Appl_Type=N&Appl_No=218139#21687;
I guess with the size and scope of the Libigel studies, it was probably too much to ask for the FDA to meet a PDUFA date within the 10 months following acceptance of the application.
Though they are less common, I found another example of another US company setting up a commercial headquarters in the US. In February 2015, Phoenix Integration set up a commercial HQ to more effective support for its customers globally. While its Corporate HQ remained in Virginia. So it is possible that by itself would not be confirmation of a buyout. The secrecy and tying up almost all authorized shares, hampering any future business development is a strong sign of pending buyout.
Phoenix Integration Establishes Commercial Headquarters
Silvr, it looks like they took is as security interest for the loan. ANIP has done this in the past.
Apologies BB, upon rereading the indenture regarding note conversions, I realized the PPS above $96.34 did not have to be consecutive but had to occur 20 times in a 30 day trading period including the last trading day of the quarter. So it looks like the conversions earliest date would come in January.
Good possibility, Silvr.
The acquiring company will apply to market the drug. As I understand it, ANIP has to first discontinue their marketing rights, before the FDA can give marketing authorization to another company.
It is getting harder and harder to hide the fact that ANIP is getting bought out.
Tezruly's Marketing Status was just discontinued. Marketing Start date was August 1, 2024. Even though, on September 24, 2024, they submitted the patent expiration info related to Tezruly, the first approved oral solution for an alpha -1 beta in the world with patent protection until January 18, 2041.
Discontinued
Tezruly Patent Protection
Prescribing details show Marketing Start Date
This explains why ANIP did not launch it.
Watch what they do, not what they say!
North, as you mentioned, I too have thought about a multi player deal, similar to the Amylin buyout. Thanks for pointing out the Walsh connection. I guess we will soon see how things play out.
Brusselsspirit, Silvr, covered the points consistent with a large announcement being made in the future. I say buyout because they have tied up all their shares, with almost no shares remaining for future business development. If not being bought out they must be they must be planning to buy back the notes as they continue to grow.
The Alimera deal may not be insignificant to the partner, but will be important to ANIP, if female testosterone is not approved, or if the company is splitting.
ANIP is obviously in some type of quiet period, logic dictates it is major news.
Good points.
Silbvr, not sure if you already mentioned this, but according to Net Gather Market Research "Unveiling Insights, Shaping Strategies: Your Guide to Market Success and Growth", Alimera Sciences and Allergan are known for their expertise in treating retinal diseases. Looks like Alimera would compliment Allergan's (AbbVie) Eye care division.
I think the delay is linked to the pending deal. As for Tezruly's trademark, Corti was approved November 1, 2021 and did not get registered until February 15, 2022.
Good info regarding Parkinsons, Dementia and glycolysis, many of these patients might need an oral solution.
I doubt we see an update until the big announcement comes out.
Looks like the jobs page was just a glitch. It is back up and still has 33 positions available.
ANIP has been adding jobs daily to their careers page over the last couple of days having 33 open positions as of yesterday. The rest of the site is up, except the jobs page. It may be routine maintenance, but I can't help but wonder if the pending update relates to the partnered NDA approval.
Just something to keep an eye on.
Thanks Brusselsspirit.
Roddy, I think your patience will be rewarded over the next 8 weeks.
If the partnered drug is female testosterone, the larger partner will want to present their findings at the American Heart Association Scientific Session scheduled for November 15 to 18 in Chicago. Ironically, if AbbVie is the partner, it is their back yard. If it is a buyout the announcement will be based on their timeline.
FYI, there is a reason MVP has not sold any shares in a while, and Blackrock is now ANIP's largest shareholder. So we are in good company.
Good luck to all.
No Problem BB. Input and knowledge, yes. Wisdom is highly questionable, just ask my wife!
If we all share info, it levels the playing field, somewhat, for us retail investors.
Jp2011, you won't find it as ANIP failed to provide any information regarding three NDAs and the FDA does not publish information on NDA submissions, most companies do their own PR. Without the info the markets have not been able to factor it into ANIP's PPS.
It is speculation on my part based on ANIP's actions.
In Q3 2023, ANIP announced they had filed two NDA's however their 10Q and 10k filing show they only paid the NDA submission fee for one of them. Therefore the partner would of had to pay for it. Secondly the Clinical trial website posted that ANIP (Biosante) had received a certification to delay posting results of the large Ligel safety/efficacy study involving 3,656 participants. Certifications to delay posting results are issued when an NDA is filed or about to be filed. Shortly after posting about this the trial's web page was changed to show that certification is one of a number of reasons for the delay in posting results. The results were due to be submitted by October 27, 2023 and are overdue.
I watch what they do, not what they say or release in a PR. That is why, I believe it is for female testosterone.
JMHO
BB, in my opinion the timing of a buyout will depend on several factors. Most important is the FDA approval of female testosterone. As long as the FDA is on schedule for the review, we should find out by next week.
As I understand it, ANIP has very few shares left to issue to the partner. They are mostly accounted for in current outstanding shares, the senior convertible note offering and the employee stock incentive program. Few shares are left for future business development which points to a buyout without paying off the senior notes, starting in September 1, 2027. Combined with the establishment of a Commercial HQ in Princeton, NJ, it looks like the buyout is the final goal.
A straight buyout offer may be announced any time after the FDA approves the partnered drug. Which would have been given a PDUFA date of September 30, 2024 or earlier, assuming all is in order and on schedule.
If there is no immediate buyout, as a defensive measure, and away to lessen the cost of a future buyout to the buyer, they may want to take an equity stake in ANIP before announcing the buyout. This will allow them to fend off competitive bids as the shareholders decide on approving the acquisition. Acquiring and converting the senior notes may be the most effective and least expensive way to accomplish this. If converting all the notes is a step in the process to making the announcement, look for the share price rising above $96.34 and staying above it for 20 consecutive trading days, as a signal. Once the share are converted the partner becomes a beneficial owner of ANIP and must be reported to the SEC. We should see an announcement upon submission of the beneficial ownership. If this is the case, some announcement(s) will come out driving PPS to $96.34 and above. With the cap call transaction in place, I think PPS will fluctuate between $96.34 and $114.02 in the 20 day ramp up to converting the notes. Track the trading days from this point, then watch for an announcement. Theoretically, the announcement could come out around Q3 earnings release.
Another possible scenario is that the partner converts the shares, the partnership is announced and the partner assumes the vacant BOD seat. This gives them a competitive advantage in a future buyout. I don't think this will happen, as it may prove more costly for the buyout and ANIP has not left themselves any shares for future business development, without seeking shareholder approval.
Bottom line if we don't see a straight buyout announcement, ANIP starts making announcements leading to a steady climb in PPS from October 1st onward.
JMHO
Good list Silvr, obviously they won't provide PDUFA dates, with name of drug and indications or naming their partner.
If ANIP is not bought out directly, I believe many of the items you have listed get addressed once the partnership is announced.
Looks like ANIP updated their career page all the Princeton Junction jobs are now located at their commercial head office. Page entry error or covering their tracks? Hard to give ANIP the benefit of the doubt with all the hold back info, so far.
I thought the same thing.
Silvr, Fox News is also covering testosterone therapy for women.
Fox News
Looks like the CVR question has been taken down from ANIP's FAQ page.
On the surface, it looks like an odd addition to their list of products. The sole US supplier is a possibility. I wonder if their version of the drug proved more effective than Perrigo's version making it worth investing in. From an R&D perspective, I am wondering if they will be looking at using it in developing combination drugs addressing unmet needs.
Regarding the convertible notes are good and bad depending on how they are used.
I now understand why the short interest rises significantly following the issuance of convertible notes. The note holder shorts the stock for the same number of shares that can be converted. ANIP gets $316.25 million offering at 2.25% works out to approximately $7.12 million in interest. Hypothetically if they could short the 4,267,305 shares for a full conversion of notes at $60, it would make cash outlay of $60,211,678 for the notes generating a return of 11.82% on this cash outlay. The trick is to ensure the note holder do not short more shares than it can convert.
As for ANIP's strategy:
It all depends on who is holding the convertible notes. If the holder is unaware of a potential buyout, they may legitimately expect to keep getting their 11.82% return on the portion of the notes they were able to short.
If, on the other hand, the partner now owns the notes, it might be cost effective way to transfer shares to partner company as they take an equity stake in ANIP. Especially, if they are eyeing a future buyout.
As for Friday's high volume, many other pharmas saw high volumes at close and after hours on Friday. It may be in response to the Federal Reserve's interest rate cut announcement.
ANIP is sitting ion another ANDA approval. On September 16, 2024 Novitium gained approval for Ketoconazole 2% topical shampoo. One they had to conduct a phase three study comparing it to Perrigo's version of the drug.
Phase 3 trial
Approval
In 2014, ANIP issued $143.75 million in senior convertible notes due in 2019. ANIP was trading around $53. Conversion price was $69.48 and they took a hedge with a strike price of $96.21. The increase in Conversion Rate upon Conversion upon a Make-Whole Fundamental Change went to $205.
Interesting that in the current senior convertible notes the increase in Conversion Rate upon Conversion upon a Make-Whole Fundamental Change goes up to $400, almost double the 2014 notes.
I believe the SECs expanded definitions of “accredited investor” and “qualified institutional buyer” would make way for a partnering company to acquire the senior convertible notes. The SEC added LLCs to the list, so long as the entity meet the $100 million in securities owned and invested threshold. Not a difficult threshold for the investment arm of a large pharma.
As I understand it, if ANIP's partner owns the notes, and wants to convert them as soon as possible, starting October 1, 2024, it is in their interest to have ANIP trading above and as close to $96.34 (130 % of the strike price for the notes) for 20 consecutive days. The partner could then convert the notes, while minimizing tax hit. ANIP's cap call transaction offsets dilution up to a PPS of $114.02.
If this is the scenario playing out, look for sustained PPS between $96.34 and $114.02, up until the shares are converted. Where a partnership announcement will be made prior to the SEC beneficial ownership report is submitted. Maybe, this is where the Tezruly announcement comes into play to help elevate PPS.
Just spit-balling here.
Silvr here is the link to the trial involving Libigel led by Dr. Susan Davis.
Phase 2 trial
Davis and company authored "Transdermal testosterone improves verbal learning and memory in postmenopausal women not on oestrogen therapy"
Delay in making any meaningful announcement may be timed to gaining approval of the partnered NDA.
Thanks Silvr, ANIP and their partner already have Phase 2 trial results supporting going to Phase 3 trial.
ANIP has also posted positions for Senior Accountant and Senior Accountant - Inventory at their Princeton Junction location.
Odd that they have just indicated the 500 Alexander Park, Princeton, NJ as their Commercial HQ, yet are not housing these positions there.
Large volume at close including one transaction involving 567,800 shares.
ANIP also posted jobs for an accounts payable specialist, a contracts and government pricing associate and a financial planning and analysis analyst for Princeton Junction.
I find it odd that they are not located at ANIP's Commercial HQ at 500 Alexander Park, Princeton.