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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.
Thanks auh2oman.
Sr Convertible Notes may start getting converted when ANIP trades at or above $96.34 for 20 consecutive days after September 30, 2024. The following is from ANIP's filing.
Thanks auh2oman.
Silvr, keeping their website up to date was never ANIP's forte. The 2023 annual report says the CVR's expired.
Thanks Silvr. Good PR prior to an approval announcement.
Jp2011, in ANIP's Q3 2023 earnings press release they stated that two 505(b)(2) NDAs were submitted to the FDA. They never provided any details on what the drugs were or for what indications.
Two weeks or less to the FDA decision on the partnered NDA, assuming there were no delays.
I think naked shorts are exiting and the short interest remaining will mostly be tied to the Convertible note offering and those playing both sides of the paint. Those with the notes obviously shorted the stock to minimize their outlay for the offering. It should be equal to the number of shares they expect to get from the conversion.
Thanks Silvr, so it looks like the ALIM acquisition fits into both AbbVie's and Merck's expansion plans.
Looks like Guggenheim got off the sidelines and raised ANIP price target to $83 from $77 (issued April 23, 2024).
Updated rating
Thanks auh2oman, with BS estimates like Truist's L. Sulewski, you can see why he only rates one star, which may be overrated, in my opinion.
Marketbeat Ratings
ANIP trading at between $64.32 and $65.49 premarket on very few shares, but is reflective of ANIP's current market cap + ALIM's market cap prior to merger announcement. Hopefully the start of the climb back to reasonable valuations.
ANIP will update guidance with Q3 results. Should be Q3 estimates with record number of new patient starts for Corti.
After Hours trading has moved back to normal levels with less than 3500 shares at the time of this post. We have seen in excess of 50,000 shares daily for several weeks. Hopefully the games are over and PPS can start an uninterrupted climb.
I find Truist's motive suspect, as their last estimate of $80 was issued March 1st, 2024. No updates since then until the recent downgrade. Whereas, H.C. Wainwright raised it to more times based on news coming out and now has a $94 price target. It is almost like they are in cahoots with hedge funds intentionally trying to depress ANIP PPS.
Analyst Ratings
Short interest as of August 30th, was 2.42 million shares. Where the hell are the shares coming from? If ANIP ever disclosed everything they have on deck, the short squeeze would be historical.
ANIP could easily screw all shorts by announcing that part of the interest savings from the Sr Convertible Note offering will be used to start issuing dividends.
Silvr, auh2oman, part of me feels that Truist is being disingenuous. An authentic analyst would know that Tezruly has been approved and that it is patent protected until 2041. ANIP management had meetings with Truist in June and we still do not know what these meeting were about.
If they are genuine and the deal is back on, they should up the price target to at least $75. $60 was excessive, and questionable at best. Failure to so, makes their analysis suspect.
JMHO
Thanks Silvr
Thanks Brusselsspirit.
Must be linked to the Eyepoint FDA warning letter regarding Yutiq. The manufacturing agreement is until 2025 and renews every two years, until such a time as Alimera start manufacturing it. I bet ANIP eventually brings manufacturing in house.
Silvr, you may be right about the naked shorts. One reason someone might buy Alim stock is to get the CVRs cheaply. They know the vote has been approved so there is no risk of the PPS dropping below their entry.
Roddy, there are a lot of hedge funds that shorted the stock when the offering came out. Playing both sided of the paint. I figure they drove price down to reacquire the shorted stock at a cheaper price. If this is the case, they expect PPS to rise
Just a possibility.
Silvr, if ANIP is not being sold, they could be setting up the Princeton location as a temporary commercial HQ with the intent of building a new corporate headquarters in the future, big enough to house their expanding needs. However, it would not explain having all their authorized shares tied up, restricting future business development options. As you said, the containment facility does not appear to be in their future plans. The corporate headquarters plant has the larger liquid dose capacity which should be very active when they launch Tezruly.
All are possible Silvr. We may not get news on launches etc. until the separation is set. Whether it involves a buyout or a spin off.
I have been researching commercial headquarters and as I understand it they are usually set up when the corporate headquarters is in another country. It makes me wonder if a foreign pharmaceutical company, or a new venture registered in a foreign country is acquiring ANIP.
ANIP has started updating there website. The Locations page now shows the New Jersey Headquarters as a commercial headquarters and Baudette facility as their corporate headquarters (for now).
Location
Probably won't get a HQ change announcement on Monday.
FAQs still list Priceton NJ as their HQ.
Whether it involves ANIP or not, AbbVie must be working on some type of deal. This past week was the first time, since spinning off from Abbott Laboratories, that AbbVie did not present at the Morgan Stanley Global Healthcare Conference. Obviously something more important appears to be in the works, which justified the new CEO missing an opportunity to lay out his vision and address questions.
They can also start a new application with the same trademark and abandon the existing one. AbbVie first applied for Eluvogue in April 12, 2018. The current application was filed September 24, 2021. ANIP's Cortrophin -Zinc trademark application is in a similar position.
I agree Monday will be fun.
Thanks North.
My guess is that Monday opens with announcing the closing of the acquisition of Alimera and the moving of their HQ.
They will likely attend the H.C. Wainwright 26th Annual Global Investment Conference between September 9-11, 2024 where they will announce on the day they attend that they gained approval for Tezruly and hopefully that they have launched it. PPS should climb on both announcements.
In a perfect world, we then we wait for the approval of Eluvogue (AbbVie trademark, if they are the partner) for the next leg up. The cat will be out of the bag by then. From there it gets interesting to see what type deal exists. Maybe a copromotion deal with AbbVie. PPS climbs some more, then Merck makes an buyout offer.
I guess we will find out over the next month.
Thanks Silvr
Looks like testosterone restoration may have a positive effect on a broad number of cancers, not just breast cancer.
Good point Dew Diligence. I checked the SEC website and went through and checked ANIP's filings. They had three NDAs under review two were filed in Q3 2023, only one showed up as an expense in the 10-Q filing for that quarter. ANIP filed another NDA in Q1 2024 and the related 10-Q filing shows it paid the submission fee that quarter. To date the second NDA filed in Q3 2023 does not show up in any of ANIP's SEC filings. The PDUFA date is likely sometime this month.
I checked the SEC website this time and found neither their 10-k filing or any 10-Q filing showed expenses for an NDA submission related to the second NDA filed in Q3 2023.
The following is from 10-k.
ANIP never confirmed the submission fee for one of the NDAs filed in Q3, They announced they filed two NDAs and in the 10 Q filing they said R&D was increased by paying for one NDA. Process of elimination points to another party funding the regulatory process for one of the NDAs
The following is from their earnings release.
Dew Diligence, I believe in the past that AbbVie had no interest in Female Testoterone (ANIP's Libigel).
I am wondering if that may have changed. In Q3 2023 ANIP filed an NDA for an undisclosed drug where the application fee (approx. $3.2 million) was paid for by an undisclosed. It appears that a Certification request to delay submitting results for Libigel was filed October 27, 2021. For your followers info a Certification is requested to delay posting results when an NDA has been or will be filed.
Seeing that the study director for all Libigel trials was Dr. Michael C. Snabes, who is a Sr. Director with AbbVie Global Research and Development. According to Snabes 4,000 years of data showed that restoring testosterone in post menopausal women at risk of CV events reduced the risk of a CV event by at least 70%. It also showed that it reduced the risk of breast cancer events by an undisclosed amount. They could be sitting on 10 year of safety and efficacy data regarding HSDD and maybe more indications.
https://clinicaltrials.gov/study/NCT00612742?term=biosante&rank=2&tab=results
If AbbVie is ANIP's partner for the first FDA approved female testosterone the application may have been assisted by the Intrinsa portfolio which AbbVie received in their merger with Allergan.
ANIP has never been announced the PDUFA or the fact that another party paid for the NDA filing.
Just trying to figure out who their partner might be. I am leaning toward AbbVie. However, they also have ties to Merck.