Opened in error

HC Wainwright raised Price Target for ANIP to $94.

PT $94

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.

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.

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

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

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.

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

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, 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.

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

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, 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

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. .

Congrats on you GERN investment, BB.

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.

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.

Here is my latest article on ANIP.

ANI Pharmaceuticals Is Undervalued, As Royalty Potential Is Overlooked

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

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

It now reads

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.

Thanks auh2oman. I like that

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

That is interesting. Thanks Silvr.

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

Thanks auh2oman

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

Silvr, I see that CGON stock has dropped significantly $28.50 and putting up daily 52 - week lows. Investors are now questioning their calculation of the complete response rate. Additionally, some are seeing, as you pointed out, the clarity of ANIP's stance vs the vagueness of CGON's stance on the matter.

CGON has much more to lose by their greed than ANIP in this matter. If they lose the ability to file an NDA, their stock becomes almost worthless.

Risk vs Reward make this a very big gamble by CGON for only 5% of net sales.

JMHO

Silvr, having read the agreement, based on case law related to collecting royalties beyond patent coverage, I believe several issues will pop up.

Good for ANIP - they tied compensation to Patents and BioSante Know-how. (patents alone they would be dead in the water.)

Possibly troubling for ANIP- the running royalties does not provide an end date.

Larger issue many drugs get marketed late in patent life. This is a case that could settle the issue for the industry.

I agree that pulling the IND could help.

In the end I see an out of court settlement rather than either side losing in court, especially as CG Oncology gets closer to filing an NDA.

JMHO

Thanks North, hopefully you are right in your assessment.

Silvr, may the minimum 18.7% stake only applied for the first 12 months?

Silvr, listening to the Conference Call, I wonder if there was a later agreement regarding dilution or if the non-dilution does not refer t common shares.

Stephen Carey

It in the institutions hands and we just ride the waves up and down.

Should be trading at new 52 week highs next week as more institutions have time to absorb the info.

Silvr, ANIP could do all a solid for all biotech by taking this all the way. How many early inventors are getting screwed, because it takes so long for drugs to get approved and each the market.

I think the markets are waking up to this fight as CGON has fallen to $28.50.

Thanks Slivr, as I read it it looks like ANIP could own 18.7 % of a $2 billion company. I agree I can see investor led litigation landing on CG Oncology's doorstep.

Regarding them hanging their hat on patent expiration. I found Beyond Hybrid Licenses—Strategies for Post Patent Expiration Payments in the United States very interesting in understanding the possible arguments and case law impacting those arguments.

When looking at the B. Kimble v. Marvel Entertainment, LLC case, if they remain consistent, it appears that, Justices Alito, Thomas and Roberts would likely side with ANIP if it ever got to the supreme court.

Record earnings beats estimate on both revenue and eps.
Gross profits over $88 million
$18.2 million in net income (GAAP).

I believe they could of raised guidance. Most likely to be raised in August.

GLTA

Silvr, if it was after hours, I would be more concerned. In the current guidance, Lalwani left lots of room to raise it. Tailwinds only included 1st quarter opportunities. It should allow for an increase. I also expect an increase in Corti guidance which should also add to the upgraded guidance.

Most likely they announce a launch or two as well and the Q10 filing should speak to litigation regarding Cg Oncology.

Hopefully we also hear about a Rare Disease acquisition.

GLTA

Thanks Silvr

Looks like ANIP is going to relaunch Kionex (Sodium Polystyrene Sulfonate) it is a drug obtained from Perrigo but had yet to bring it back to market. ANIP updated the trademark revived the trade mark for Kionex in March.


Drug Shortage

ANIP got approval for manufacturing on May 3rd.

Approval

Trademark