ANI Pharmaceuticals Inc (ANIP) News

I agree, unlike some biotechs, ANIP doesn't need to dilute shares to stay listed, there must be an advantage to keeping quiet. The following are possibilities.
1 - The partner is acquiring shares in the open market.
2- A deal where ANIP shareholders receive shares of the acquiring company. For tax purposes, it is advantageous to lowball the value of the deal. ANIP share holders would still be somewhat protected and get to share in the future gains.
3- More questionable, ,and I don't believe is happening is that executive and board compensation package would include a lower strike price on stock options.

JMHO

What still is not clear to me is why their are not showing all their cards? They should be interested in having a fair company evaluation by the market.

Thanks for that comparison between ANIP and TGTX, JTFM. We own 1000 shares of ANIP in a taxable account, but I now wonder whether 300 shares of TGTX in cash-poor IRA is enough to take appropriate advantage of that projected growth shown by data in your message. At age 87, I think I have time to sell something else of less current value in IRA......kind of like me wondering whether Commanders and Daniels will continue today's success in future NFL games this season and future seasons. 

Hi offer1. I don't think this is possible. You can sign up for free.

Hi silvr_surfr,
Can you publish the related article on this board? (I don't have access to SA)
Thanks

Silvr, I look at a company like TG Therapeutics which is currently according to Seeking Alpha is valued at $3.86 billion.

Fiscal Period Ending Revenue Estimate
Dec 2024 $327.76M
Dec 2025 $505.95M
Dec 2026 $690.69M
Dec 2027 $1.11B
Dec 2028 $1.39B
Dec 2029 $1.62B
Dec 2030 $1.76B
Dec 2031 $2.06B
Dec 2032 $2.29B
Dec 2033 $2.53B

Imagine where ANIP would be valued, if they showed all their cards and put out pipeline, as most biopharmas do. An accurate pipeline disclosure could easily see some analyst estimating revenue north of $4 billion by 2033.l

JMHO

JTFM, just read your article on Seeking Alpha. If half of what you lay out happens, I would be happy. Well done.

GLTA

Thanks Brusselsspirit

Fyi Mallinckrodt reporting on Tuesday morning 

Mayo Clinic Proceedings is publishing Androgen Society Position Paper on CV Risk with Testosterone Therapy in November.

Dr. Morgentaler notes patients can be assured this therapy is safe with regard to cardiovascular risk and clinicians need no longer restrict use of testosterone therapy because of concerns regarding cardiovascular risk. Future research should now explore potential benefits of testosterone therapy for both men and women, as suggested by prior research.

Hopefully they publish Libigel Study results as well.

Youtube clip

ANIP presents earning next Friday. I wonder if the PDUFA date is next week. Hopefully they will start more being transparent with respect to:
- Partnered NDA (pending PDUFA)
-Tezruly approval then discontinued (patent protected to 2042)
- Corti patent protection to 2043.
- PDFA date for NDA filed in Q1 2024.

Good news JTFM. Regardless, they need to book some synergies so this is always the low hanging fruit.

Alimera recently posted 11 positions in Germany. These appear to have been taken down. I don't think they would of had time to fill them. It makes me wonder if the pending deal with ANIP's partner would make these position redundant and are closer to an announcement.

Thanks Silvr, only a matter of time.

The PR continues for female testosterone. Based on this article it is a lay-up to reincarnate Libigel.

Today Show Article

Thanks JTFM

Roddy4, it is hard to say exactly when. I estimate that they had a PDUFA date which the FDA could not meet, due to the massive amount of data to be reviewed. So we are just waiting for them to complete the review. Sometime the FDA automatically extends the PDUFA to give them additional time to complete a review. Since the NDA submission was between July 1, 2023 and September 30, 2023, we could see a decision soon. If approved, I expect a major announcement to be made prior to the approval being added to the FDA website. Since ANIP has not provided the PDUFA date, it is impossible to estimate exactly when we should hear.

Thanks. When will we know about female testosterone?

Roddy4 and Brusselsspirit, I agree on the manipulation. Personally, if they are not being bought out at a fair price, I would love to see them star paying dividends. At only 21 million shares, the dividends would prove to be very lucrative in the coming years.

JMHO

I agree ! Stock price below last year . Business results ignored . I don’t know what but there is something behind this stock

I agree ! Stock price below last year . Business results ignored . I don’t know what but there is something behind this stock

This stock is manipulated like crazy. It's obvious when you look at the rest of the market. I don't know how this is acceptable. Very, very frustrating.

https://finance.yahoo.com/news/ani-pharmaceuticals-announces-fda-approval-105000972.html

Thanks for the update Silvr.

Somebody bought 800 shares at $64.79 pre market. Usually big jumps up or down are in small (10 or less shares ) transactions. Hopefully, the uninterrupted climb is about to start.

No verdict yet on the motion to dismiss for the CG Oncology lawsuit that I have found yet, but the case file is many pages long so there is lots happening. I did come across a separate subpoena here in a different court (see below) back in late August.

ATTC Subpoena

They subpoenaed American Tissue Type Culture for various records. They did it in DC since I believe that is where this company is located. If I understand it, this company provides and houses reference standards for different cell lines. This is probably where the handoff occurred from Biosante to Cold Genesys (now CG Oncology) for the CG0070 product that is being used in the clinical trials.

There is lots at stake for this dispute and it looks like our team is putting up a good fight.

Hopefully Libigel is next. Maybe ANIP will finally start publishing a pipeline of drugs under development with partnerships.

Thanks JTFM. Yes, it does not seem like something that would be done with a buyout in hand.

Some interesting news today about the Estradiol Gel launch. While it is a small market, this is a reincarnation of Bio-E Gel or Elestrin from Biosante. Maybe Libigel is next up?

ANIP is strengthening their legal team by hiring a Corporate Transactional Attorney and an Associate General Counsel–Litigation & Employment

Corporate Transactional Attorney

Key Responsibilities

Contract Drafting and Negotiation
Draft, review, and negotiate a variety of contracts, including but not limited to, customer agreements, R&D agreements, vendor/services agreements, confidentiality agreements, consulting, commercial, distribution, supply and development agreements.
Work closely with the Legal Team paralegal to maintain the process and database, develop and update templates and maintain/develop processes relating to vendor and contract management.
Advise on legal risks, business strategies, and other issues related to contract management.
Ensure contracts comply with federal, state, and local laws and regulations, as well as industry standards.
Develop and implement contract management policies and procedures to mitigate risks and ensure compliance.

Mergers & Acquisitions/Strategic Transactions
Assist the General Counsel in managing legal aspects of M&A and strategic transactions, including due diligence, negotiation, drafting and closing.
Provide legal advice to multiple business units across the Company, including, but not limited to, Corporate Development and Finance by, among other things, reviewing, draft, and negotiating share purchase agreements, asset purchase agreements, license agreements, co-development agreements, proposals, bids, term sheets, conducting due diligence, and other related activities.
Support advising on deal structure, negotiation strategies, and risk management.
Help coordinate with internal and external stakeholders to ensure smooth execution of transactions.
Support overseeing integration activities from a legal perspective, ensuring compliance with all regulatory requirements and alignment with corporate objectives.
Support due diligence for M&A activity, including working with outside advisors supporting the process.

Key Responsibilities

Litigation and Employment Matters

Identify legal and regulatory risks facing the company, and develop and implement strategies for mitigating those risks while successfully enabling the company’s business objectives.
Manage global litigation, pre-litigation disputes, and regulatory investigations, advising senior leadership and cross-functional partners regarding an assessment of risk, financial impact, and range of potential legal solutions.
Manage subpoena compliance and response, including enhancing compliance strategy for operational effectiveness.
Manage the employment and immigration legal functions, ensuring critical legal support for our HR team on employment law, compensation, and benefits matters.
Partner closely with Compliance and other departments to provide pragmatic and actionable advice, develop new policies, or implement strategic revisions to existing policies/procedures as part of the company’s overall risk management.
Serve as the primary advisor for document retention policies, procedures, and operations, including in-house e-discovery matters.
Monitor trends and legal developments, particularly those that impact the pharmaceutical industry, analyze the implications for the company, and ensure the company is well-positioned to respond and react accordingly.
Act as the primary legal liaison for all internal investigations, regulatory inquiries and investigations.
Risk Management

Responsible for overseeing and managing ESG initiatives for the Company and for monitoring changing regulations relating to ESG. Work closely with the General Counsel and SEC team on disclosure issues.
Develop and implement risk management strategies to mitigate legal risks and ensure compliance with federal, state, and local laws, such as FCPA/anti-bribery and FDA compliance issues.
Support creation and maintenance of policies and procedures to manage and mitigate risks.
Assist in conducting internal investigations and managing responses to regulatory inquiries and audits.
Data Privacy/GDPR

Ensure compliance with data privacy laws and regulations, including GDPR.
Support the development and implementation of data privacy policies and procedures.
Conduct risk assessments related to data privacy and implement measures to mitigate identified risks.
Collaborate with internal teams to ensure data privacy compliance across all business operations.
Provide training and raise awareness on data privacy issues among employees and stakeholders.

Princeton Legal Search

Litigation Lawyer

It makes me wonder if ANIP forms a partnership(s) before eventually being bought out.

I agree, that is interesting.

Thanks Silvr

Thanks Brusselsspirit.

Wow, yes, most interesting. Thanks.

Interesting Coincidence ...

Today's news regarding the pre-clinical date and the potential role of melanocortin receptors, in this case, the underlying disease pathologies within nephrotic syndrome was an interesting development for ANI. Also today, Palatin Technologies, Inc., a company I invested in back in the spring, released data focusing on their research regarding it's melanocortin drug development platform:

https://palatin.com/press_releases/inflammatory-disease-healing-data-via-palatins-novel-melanocortin-receptor-agonists-presented-at-the-19th-annual-peptide-therapeutics-symposium/

Here's the October 2024 Corporate Presentation:

https://palatin.com/wp-content/uploads/2021/09/PTN_Website_Corp_Presentation_Final_100224.pdf

They are located around the corner from ANI's "New" Headquarters.

Thanks Brusselsspirit, As they say, I did not have pre-clinical research sponsored by us on my bingo card. Excellent to see. The little bit I have read about this condition is that it affects 1 in 5000 people. The same researcher has a recent paper highlighting the benefit of cortrophin gel for it.

Membranous Nephropathy

I imagine the regulatory path will be different to get claims approved for an established drug vs a new one. Having the science behind it is also key.

https://investor.anipharmaceuticals.com/news-releases/news-release-details/ani-pharmaceuticals-present-new-data-highlighting-membranous

Yvette Zymerman was named Pantarhei's CEO in 2019.

https://www.pantarheibio.com/wp-content/uploads/2019/01/Press-Release-New-CEO-Pantarhei-Bioscience.pdf

Thanks Silvr, regarding private status, I guess they are not looking to get another job in a potential buyout. Seems to me that head hunters won't notice them.

I also found a note in a recent research paper saying their long time President and brain trust, HJT Coelingh Bennink, retired.

Definitely a deal going down. Their Oncology site does the same thing. If you look at the employees on Linkedin, they all have private status except one. Olav Andriessen, was just added to the board and is an M&A guy from Galatea business lawyers in Amsterdam.

Interesting.

Thanks Silvr, as I understand it, Besin partnered with Unimed (Abbott-now AbbVie) and had a 50/50 IP deal. Robert E. Dudley (Unimed) and Robert E. Dudley, Dominique Drouin (Besin's Healthcare) were coinventors regarding Androgel,

In 2012, after Antares got the their patent, Abbott abandoned their patent application which was also assigned to Besin's.

Method of increasing testosterone and related steroid concentrations in women

I guess we will soon find out if they are part of the deal.

Weird, someone bought 15 shares @ $63.32 in after hours yesterday (17:00:03) 🤔

Something is up with Pantarhei Bioscience (our "Pill Plus" product). Their website has been reduced to a single page. Maybe the chess pieces are starting to move?

I have been watching for any relevant news coming out of this weekend's Menopause World Congress. There is some noteworthy news from Besin's Healthcare Linkedin. They unveiled a "new website dedicated to helping women around the world to Stay on Top of menopause! " They also advertise on Linkedin one of their subsidiaries, the "HRT Club", which will allow men and women to order hormones directly online to bypass the pharmacy.

JTFM may be able to replay the history better, but Besin's I believe was part of the original Libigel patent. It also was involved with Abbvie's Androgel. Is this another scenario unfolding where Besin's is now somehow involved with a Libigel launch? If so, they will have a ready-made distribution system.

Excellent JTFM. This supports the PR about its use for women's bone health.

Another reason to approve female testosterone. Future real world evidence could support treatment of osteoporosis.

High SHBG and Low Bioavailable Testosterone are Strongly Causally Associated with Increased Forearm Fracture Risk in Women: An MR Study Leveraging Novel Female-Specific Data

Thanks Silvr.

That would be great JTFM. In fact, Michele Tagliati is the lead investigator for two of the three active Terazosin clinical trials for Parkinson's Disease. She is one of the Course Directors for the November 2 "X Cedars-Sinai Parkinson's Disease and Movement Disorders Annual Symposium". She is also giving the plenary talk.

Michele Tagliati

As you will see (click on Faculty), she is still in a consulting arrangement with Abbott Laboratories, but no longer with Abbvie or Cerevel. Abbott was the original developer of Hytrin.

Thanks JT, I know I can always rely on this board for guidance.