ANI Pharmaceuticals (ANIP)

[Just the facts maam]

HC Wainwright raised Price Target for ANIP to $94.

PT $94

[Just the facts maam]

I agree Silvr, many catalysts on the way. ANIP's PPS had lower day end closes from June 7th to the day before the announcement of the acquisition. While Alimera went from 98,200 shares traded on June 10th to 1,675,800 shares traded June 11th. Sure looks like word of the acquisition got out prior to the announcement.

Congrats to Nikhil. I believe it was for the New Jersey area hopefully he gets their national award next year.

[Easka]

Thanks for the reply and feedback. Looking at the last three analysts all had Strong Buy recommendations on Alimera before Ani's buy offer.
I think you are right they made a good pick (at the right time) and a good fit with their Rare disease business. It was worth the wait.

[silvr_surfr]

Thanks JTFM. I had the same thought. Lots of catalysts for growth over the coming year. The market seems to like it as well, although it sure looks like they took it down in advance of this "news". I don't know if you saw this, but Nikhil was named "Entrepreneur of the Year" by E&Y.

[Just the facts maam]

It looks like the Alimera deal does not involve the meetings ANIP management apparently had with Truist June 13 - 16.

ANIP may just be getting started.

[Just the facts maam]

Easka, based on analyst estimates when combined ANIP's current EPS estimates for 2031 should be raised from $7.31 to 16.59 (less any further dilution).

It should add the following to ANIP's EPS (less any dilution).

2025 =$0.70
2026 = $1.18
2027 = $2.83
2028 = $4.37
2029 = $5.69
2030 = $7.34
2031 = $9.28

[Just the facts maam]

Easka for 2028 estimates the analysts were Yi Chen of H.C. Wainrright & Co., Naz Raham of Maxim Group and James Malloy of Alliance Global

Stock Analysis- ANIP

For 2031 i got it from Seeking Alpha - the analyst is not provided.

Seeking Alpha

[Easka]

Thanks JTFM, who was the analyst that stated that and do you have link?

[Just the facts maam]

Analyst predicted Alimera on its own would generate $234 million in revenue by 2028 and $384 million in revenue for by 2031. Looks like a good pick by ANIP.

[Just the facts maam]

ANIP starts to expand sales globally with acquisition of Alimera Sciences. It is good for the reps selling Corti to ophthalmologist.

[Just the facts maam]

I noticed that since the May earnings there were three trading session with over 300,000 shares traded. The first traded as high as $70 and was dragged down to as low as $60.36 before starting its climb back up $69.09 before the next >300,000 share trading session. We are now on our 10 consecutive day of lower closings with volume on Friday was above 300,000 again. Meanwhile institutions know that ANIP set new record patient starts for both April and May. Certainly looks like controlled accumulation.

When they are done accumulating we should see it climb back to $70ish range and blow by the $81.60 target price (maybe closer to $87 for the only target price that was issued after May's Corti sales information.



JMHO

Just my opinion.

[174ahc]

Thank you

[Just the facts maam]

174ahc, I am not worried as the majority of sales are by Samy for Esjay Pharma LLC followed by Gassert for Chali Properties as part of trading plans filed in 2023. Esjay is a pharma company operating out of Novitium plant at 70 Lake Drive East New Jersey. I believe that Esjay's use of the money will eventually benefit Esjay and ANIP. The only employee selling any sizeable portion of shares is James Marken, could be for a number of reasons. No negative news has come out. The only negative so far is that ANI has yet to pull a trigger on the rare disease deal. ESP has been fully diluted by the shares issued Q2 of 2023 to fund the deal without any revenue to offset the increase in outstanding shares I am more interested in their meeting with Truist. It may be related to the acquisition. Once a deal is announced which is suppose to be accretive to share holder value, we should see a rise in EPS estimates, especially long-term as they are looking for asset with patent protection and long-term growth. This should course correct ANIP's share price.

[174ahc]

Why are so many insiders selling with no buying, do they know something we don’t ?

[Just the facts maam]

According to the The Fly, ANIP Management had meetings with Truist June 13-16. LikleIy related to Rare Disease expansion, female testosterone or both.

Truist Meetings

[Just the facts maam]

None that matter. I haven't seen any either. Regardless I am not worried, especially when taking a long-term view. I was looking at profitable North American Based Pharma and Biotechs and I only found 5 where analyst estimated consistent YoY growth in revenue for the next 10 years. ANIP was one of them. The others include Vertex, Ligand, and two other that I am looking further into. Might be the basis for another article.

JMHO

[Jp2011]

Thanks JTFM. In the same article they mention 4 downward revisions. I have not seen any downward revisions have you?

[Just the facts maam]

Jp2011, I am not too familiar with Options trading as well. However, I am not concerned. Just checked Seeking Alpha they have no open interest for any Puts price below $60. While Yahoo has Open Interest for 5 Puts (1 Put = a 100 share block) priced below $60.

Very low volume. I think as you said it looks like a hedge fund driving price down to accumulate more shares.

JMHO

[Jp2011]

JTFM,
I do not know much about options but just read the article from Zach’s about ANI. What is your take on that? Not sure if that is a negative or positive thing? If negative wouldn’t be surprised if it is just a scare tactic, but the trading recently has been a bit odd…

[big bambino]

Well than Jeff, if your still here, THANK YOU 😆

[Just the facts maam]

I am pretty Jeff was at least one of the board members identifying GERN as a potentially good investment. There may have been others, but I can't recall who it was. .

[big bambino]

Thanks JT, only wish I could remember who pointed me in that direction (I think it was Jeff). Originally bought in at $3.90, but the constant bashing and good results, I kept averaging down. Truly believed in what they were doing 😃

[Just the facts maam]

Congrats on you GERN investment, BB.

[big bambino]

Thanks JT, my other one (gern), which I got from this board just got FDA approval. have 23K@ $2.20. EOD was $5.04, with talk of possible buyout down the road. May sell some to pick up more Anip. I really appreciate everything I learn from here.

[Just the facts maam]

Silvr, though I stated that ANIP should be trading north of $81.69. I found by discounting 30 % per year to peak sales, a method Leerink Swan used for Libigel in 2011, ANIP's PPS today should be above $90. However I thought using the GCON valuation as a base to establish a fair price today was more objective.

[Just the facts maam]

BB this is the summary of the article.

- ANIP's potential royalty revenue from two upcoming drug applications could generate $415 million annually, not reflected in the current share price.
- ANI Pharmaceuticals' legal action against CG Oncology could result in royalties for Cretostimogene, potentially adding $125 million per year.
- The Company's female testosterone drug could generate royalties of $290 million per year, with potential for additional indications and international sales.

If all falls into place Royalties could add $16.89 to ANIP EPS (less dilution) by 2031. Analyst currently estimate EPS for 2031 at $7.31.

[big bambino]

JT, I wasn't able to read it but I'm sure it was insightful and with precision as all of your work is, Thank you

[silvr_surfr]

Well done JTFM! Thank you for continuing to champion our stock.

[Just the facts maam]

Here is my latest article on ANIP.

ANI Pharmaceuticals Is Undervalued, As Royalty Potential Is Overlooked

[Just the facts maam]

CORRECTION: The following are NOT considered good cause for an extension to delay submitting results. I imagine the same goes for certification.

[Just the facts maam]

It is obvious that they make no mention of an extension request to delay, so the submission was definitely for certification.

The following are considered good cause for an extension to delay submitting results. I imagine the same goes for certification.

• Awaiting journal publication. A study must report clinical trial results information even if the data have not yet been published.
• Pending U.S. Food and Drug Administration (FDA) or other regulatory or health agency review. A study must report clinical trial results information even if the data are under FDA or other regulatory or health agency review, consistent with any certification of delay submission, as applicable.
• Ongoing data analysis without sufficient explanation. All studies are expected to be able to complete data analysis within one year of the Primary Completion Date unless there are unexpected circumstances that prevent the timely completion of the analysis. Analysis that is not yet complete, without further explanation, is not adequate justification for “good cause.”

They have been analyzing the data for almost 3 years. I believe it is ready to go.

I also believe there is an event pending that will explain all the secrecy and delays.

JMHO

[silvr_surfr]

Yes, it is sure the mystery. I am ready to hear whodunnit.

Can't we eliminate the last three causes since: 1) the deadline for results has passed; 2) the study is required to submit results; and 3) they would not have changed the text if the investigator had only sought a certification to delay. Perhaps there is substantial analysis required for the ten years with medical follow ups along the way to present their findings. Would this include a peer review which would take even longer?

[Just the facts maam]

Silvr, FYI, they changed some of the information from the Libigel trial results page.

It now reads

Study results have not been submitted. This may be because the study isn't done, the deadline for submitting results hasn't passed, this study isn't required to submit results, or the sponsor or investigator has requested or received a certification to delay submitting the results.

When it use to say

The sponsor or investigator has requested or received a certification to delay submitting the results

Results

Looks like they are trying to deflect attention.

[Just the facts maam]

Listened to the Jeffries Presentation. Good to see that Corti is continuing to roll. May set a record high for new patient starts and this is on top April's new high of patient starts.

Should make for a nice in crease in guidance in August.

[auh2oman]

Jefferies Global Healthcare Conference Presentation ...

You have to scroll down to exhibit No. 99.1:

https://www.sec.gov/ix?doc=/Archives/edgar/data/0001023024/000102302424000067/ani-20240605.htm

[auh2oman]

Bulk Manufacturer of Controlled Substances Application: ANI Pharmaceuticals, Inc. ...

https://www.federalregister.gov/documents/2024/05/31/2024-11879/bulk-manufacturer-of-controlled-substances-application-ani-pharmaceuticals-inc

[Just the facts maam]

Thanks auh2oman. I like that

Psilocybin (7437) will be imported for use in dosage form development leading to use in clinical trials

. which was in previous applications.

[auh2oman]

Importer of Controlled Substances Application: ANI Pharmaceuticals Inc. ...

ANI has submitted another application:

https://www.federalregister.gov/documents/2024/05/30/2024-11794/importer-of-controlled-substances-application-ani-pharmaceuticals-inc

[big bambino]

I would like to wish everyone a happy and healthy Memorial day, along with my thanks for those of us who served our country. God Bless you all 😀

[big bambino]

Feels like the old days, great earnings and down ,down, down we go, 🤣. Just gotta love the MM boys

[big bambino]

Nice find JT, thanks

[silvr_surfr]

Thanks JTFM. I saw that previously, but never connected the dots to a Libigel approval. What a seal of approval if an FDA-approved study is ultimately used to approve our product. Also may speak to the complexity of presenting the data to FDA which is why it is taking so long.

[Just the facts maam]

I find it interesting that in 2016 the FDA funded the following in 2016.

Cardiovascular Risk of Testosterone Treatment in Women (Special Funding) - Lai-Ming Lee, PhD/CDER

A variety of testosterone products are used off-label for the treatment of female sexual dysfunction (FSD). Due to the chronic nature of FSD, these products are anticipated to be used as long-term therapy in women. Therefore, assessment of cardiovascular risk will be an important factor in the risk/benefit determination. The Framingham General Cardiovascular Risk Score predicts the 10-year risk of all cardiovascular events including coronary heart disease, stroke, transient ischemic attacks, and heart failure. The variables used in the formula are age, sex, systolic blood pressure, total cholesterol, high-density lipoprotein, use of hypertension medication, smoking status, and history of diabetes. We hypothesize that the Framingham General Cardiovascular Risk Score will be useful in estimating cardiovascular risk of drug products in Phase 3 trials. We will use available data to determine the utility of the Framingham General Risk Score to estimate the cardiovascular risk in women exposed to drug products with a likelihood of a cardiovascular signal. If successful, this formula would be applied to androgens and androgen-like products being evaluated for the treatment of female sexual dysfunctions in women.

I would not surprised if this forms part of the post marketing surveillance is part of Libigel or whatever it will be called. I would be highly surprised that the Libigel trial did not collect the 10 years of safety data, even if they stopped using the drug in 2012 or 2016. The 10-year post marketing surveillance will collect real world safety data for a total of 10 years.

FDA Office of Women's Health Research Program Awards by Funding Year

[Just the facts maam]

That is interesting. Thanks Silvr.

[silvr_surfr]

Here's a new researched benefit for testosterone for women:

Testosterone and Brain Volume

[silvr_surfr]

Thank you JTFM. I like the idea of nearly doubling the earnings per share for the each of the next two years.

[Just the facts maam]

Fintel shows two analyst estimating ANIP's average EPS of $8.25 in 2025 and $15.20 in 2026.

I wonder what event(s) they are seeing, it is unlikely to related to CG Oncology. The following are Fintel's Analyst Estimates

Date EPS Average (Quarterly) Number of Analysts (Quarterly) EPS Average (Annual) Number of Analysts (Annually)
2031-12-31 -- -- 7.57 3
2030-12-31 -- -- 10.32 3
2029-12-31 -- -- 9.62 3
2028-12-31 -- -- 9.23 3
2027-12-31 -- -- 6.87 4
2026-12-31 -- -- 15.20 2
2025-12-31 1.16 3 8.25 2
2025-09-30 1.13 3 -- --
2025-06-30 1.22 3 -- --
2025-03-31 1.10 3 --
2024-12-31 0.98 3 4.56 6
2024-09-30 1.03 3 -- --
2024-06-30 1.07 3 -- --

Fintel

[Just the facts maam]

Thanks auh2oman

[auh2oman]

ANI News ...

ANI Pharmaceuticals price target raised by $4 at H.C. Wainwright.

https://thefly.com/news.php?symbol=ANIP%2C+&x=44&y=8&market_stories=on&hot_stocks_filter=on&rumors_filter=on&general_news_filter=on&periodicals_filter=on&earnings_filter=on&technical_analysis_filter=on&options_filter=on&syndicates_filter=on&onthefly=on&insight_filter=on&market_mover_filter=on&e_inter_filter=on&mid_wrap_filter=on&sec_wrap_filter=on&analyst_wrap_filter=on&analyst_recommendations=on&upgrade_filter=on&downgrade_filter=on&initiate_filter=on&no_change_filter=on&events=on

[Just the facts maam]

Mallinckrodt reported sales of Acthar as

Q1 2024 $102.8 M vs Q1 2023 $82.0 M

An increase of $20.8 M YoY

ANIP reported an increase of $20.6 million in Corti sales.

Looks like ANIP and Mallinckrodt are splitting the growth in the market 50/50.

Mallinckrodt's Q1 filing