ANI Pharmaceuticals (ANIP)

[Just the facts maam]

Thanks auh2oman

[Just the facts maam]

Thanks Silvr, so they are disputing right for ANIP to receive royalties.

Where would they be without CG0070. Pure greed.

[silvr_surfr]

Congrats all.

Here is an update on CG Oncology from the 10K:

On November 15, 2010, ANI, formerly Biosante, entered into an assignment and technology transfer agreement and stock subscription agreement (collectively the "CG Agreement") with CG Oncology, Inc. formerly, Cold Genesys, Inc. (“CG Oncology”), pursuant to which the Company sold to CG Oncology exclusive, worldwide rights to develop and commercialize BioSante’s oncolytic virus technology. The technology includes a replication-competent adenovirus that has completed clinical trials for treatment of superficial bladder cancer. Under the terms of the CG Agreement, the Company received an equity investment in CG Oncology, an upfront cash payment and the right to receive future royalty payments. Historically, this equity investment was recorded at cost and as of December 31, 2023, this equity investment was valued at zero. On January 24, 2024, CG Oncology completed their Initial Public Offering, at an offering price of $19.00 per share. The Company currently holds 219,925 shares of common stock in CG Oncology. As of February 27, 2024 these shares are valued at approximately $10.2 million.

On February 28, 2024, CG Oncology disputed the Company's rights to receive royalties. The dispute is unresolved at this time.

[auh2oman]

The Other Day ...

Posted an article written by a Pharmacist, Michele B. Kaufman, for The Rheumatologist, regarding the approval of Indomethacin last month for patients who are unable to swallow solid dosage forms. Indomethacin is approved to treat patients with rheumatoid arthritis, ankylosing spondylitis, severe osteoarthritis, acute painful shoulder (tendinitis and/or bursitis) and acute gouty arthritis.
This can only create an awareness among professionals in the field of Rheumatology that there is an 180 day market exclusivity granted to ANI Pharmaceuticals for the generic NSAID and they very well could be writing scripts for Cortrophin for their patients already or this approval, more importantly, could get those sales people in the door to increase those Cortrophin 1 ml vial size for the adjunctive treatment for this condition as well as promoting their exclusivity with Indomethacin.

BTW, Great Numbers Today !

[Easka]

JTFM Another beat and Raise, great qtr and year. Agree, they will keep adding to full year guide as we move throughout the year. I still project ~ 575M for 2024.
R & D expenses increased in 23 to ~ 9M, i think he said and will grow more in 24 to support generics. Looking at multiple targets for M & A this year. I can't understand why he can't give more detail on the 1ml vile for gouty arthritis. He says he doesn't want to give out any competitive information, But They are the only
supplier approved for this indication! Doesn't make sense.

[Just the facts maam]

Good earning CC Lalwani went into greater detail into what is fueling Corti growth, indicating they see a long runway for growth. Still would not provide details regarding 1ml vial's impact on growth due to it being early in the launch.

Q1 Corti sales expected to dip over 2023 Q4, as coverage for 2024 is established. Then continued quarter over quarter growth continues. This Q1 dip appears common in the rare disease business.

Just like last year, increased guidance, as the year progresses.

[SparklingDruid26]

ANI Pharmaceuticals Inc (ANIP) Reports Strong Growth in Q4 and Full-Year 2023, Sets Positive ...

https://finance.yahoo.com/news/ani-pharmaceuticals-inc-anip-reports-121156111.html

[auh2oman]

FDA Update: Approval for Generic NSAID ...

Michele B. Kaufman, PharmD, BCGP | February 27, 2024

New Generic NSAID
The U.S. Food & Drug Administration (FDA) approved an abbreviated new drug application for indomethacin oral suspension. This non-steroidal anti-inflammatory drug (NSAID) is a generic version of Indocin Oral Suspension.1

Indomethacin is approved to treat patients with rheumatoid arthritis, ankylosing spondylitis, severe osteoarthritis, acute painful shoulder (tendinitis and/or bursitis) and acute gouty arthritis. This suspension is advantageous for patients who are unable to swallow solid dosage forms.2

The current annual U.S. market for indomethacin oral suspension is approximately $4.1 million. This approval grants ANI Pharmaceuticals Inc. 180 days of market exclusivity.1

https://www.the-rheumatologist.org/article/fda-update-approval-for-generic-nsaid-new-boxed-warning-for-denosumab/

[Just the facts maam]

Medspray angle for Libigel would be very interesting. Walsh is well positioned to guide a partnership.

[Just the facts maam]

Thanks Dasgrunt.

[Just the facts maam]

Congrats on sticking with NVDA. I agree on the acquisitions potential or at least some strategic partnerships.

[silvr_surfr]

Interesting development dasgrunt. Medpharm has the MedSpray technology. I believe it was used in Axiron which is now discontinued. I recall JTFM mentioning it once before. Maybe there is a Libigel angle here although Medpharm is not a production manufacturing company.

Another possibility is that we will see more 505B introductions by ANIP behind the MedSpray delivery technology.

[north40000]

From CDMO to ANIP to MedPharm. Lots of catalysts for future acquisitions of either or both. Thanks dasgrunt, Jtfm, Silvr for the continued due diligence. CDMO, ANIP and AMRN share prices each closed + today, along with our two largest equity holdings, NVDA and VCEL. We purchased 755 shares NVDA at a split adjusted cost basis of $4.31 per share over a decade ago for a total LTCG gain today of ~ $592,893/share, 18,233 gain%.

[dasgrunt]

Patrick Walsh now MedPharm Board

https://cw39.com/business/press-releases/cision/20240226NE44627/medpharm-welcomes-new-board-members-appoints-industry-veteran-patrick-walsh-as-executive-chairman/

[Just the facts maam]

Thanks Silvr,

Easka, I believe Lalwani previously stated that in addition to proceeds the sale of the plant, it would add $7 million in operating income, on an annualized basis.

[Easka]

Silvr, Yes good news about Oakville, will no longer be a drain on earnings. Should bode well for Q1 guide, even though it's a one time number.

[silvr_surfr]

Good news JTFM. It looks like there are two possible treatment modes. One on a pre-natal basis to prevent it from occurring (it would be hard to prove that in a clinical study) and the other to treat the condition itself.

On a separate topic, it looks like they finally sold the Oakville plant for $14M. Deal will close in March.

Oakville Plant Sale

[Just the facts maam]

Study shows that lower testosterone is a cause of endometriosis, in addition to elevated estrogen. This is yet another compelling argument to get an approved female testosterone to market to support yet another trial.

Lower testosterone as a cause of endometriosis article

AbbVie already markets Orilissa to lower estrogen and Dr. Michael SNABES is listed among the inventors of Orilissa related IP.

Another potential use for female testosterone that would attract AbbVie.

[silvr_surfr]

Thank you JTFM.

[Just the facts maam]

A bidirectional Mendelian randomization study (not peer reviewed yet) found that genetically predicted increases in serum testosterone levels by one standard deviation were associated with a 58.7% decrease in the risk of developing Idiopathic Pulmonary Fibrosis

Reseaerrch Article

[auh2oman]

Correction: ANI Upgraded by Truist Securities ...

Truist Securities has decided to maintain its Buy rating of ANI Pharmaceuticals
ANIP

and raise its price target from $70.00 to $72.00, not from $60 :

Looked at the FLY after reading their upgrade, saw the following:

07/21/23 Truist
ANI Pharmaceuticals price target raised to $60 from $52 at Truist

https://thefly.com/news.php?symbol=ANIP%2C+&x=43&y=10&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

Apologize for the confusion!

[auh2oman]

Finally, That Upgrade...

Truist Securities upgraded ANI today to $72 from $60 :

https://www.streetinsider.com/Analyst+PT+Change/ANI+Pharmaceuticals+%28ANIP%29+PT+Raised+to+%2472+at+Truist+Securities/22791724.html

[Just the facts maam]

ANIP started marketing Hyoscyamine Sulfate in various forms. I believe it is a DESI drug which has yet to be approved.

Hyoscyamine Sulfate

[Just the facts maam]

Thanks Silver.

[silvr_surfr]

Science wins. Here is one of the best proof points I have seen about the "cardio-protective" effect of testosterone for post-menopausal women.

Higher Testosterone Associated with Higher HDL

[DEVJ]

Cvr(s) in my Fidelity account are shown to have expired on 2/13/24. Oh well, what could have been.

[silvr_surfr]

Meanwhile CGON is up to almost $47/share.

[silvr_surfr]

Hey North. The Teva acquisition is another good possibility. They have a stake there as well. It looks like they don't fool around so it should not be long before we see what they are up to.

[north40000]

What other entities has Rubric Capital Management (David Rosen) invested in? Patent based pharmaceutical? Generic pharmaceutical? Both? TEVA? Is Rubric interested in M/A of ANIP with/by TEVA? PAR in India? Other generics that may have interest in patent protected technology?

[silvr_surfr]

Rubric owns a 14% stake in Mereo Biopharma and recently gained 4 board seats there. Maybe they want a go to market US team for Mereo's pipeline.

Mereo Board Seats

[silvr_surfr]

We have a new "activist" hedge fund acquiring more than a 5% stake recently. .

Rubric Capital Management

They also recently acquired a large stake in the Russell which is a bullish sign for us. They also appear to be a large rare disease investor. Interestingly, their recent stake in Heron Therapeutics may.show a sign of things to come. They were able to negotiate three board seats. If you look at Heron's stock performance after their investment, it has rebounded remarkably from a long term significant decline.

What activism do they have in store for us? Maybe they want to have a say in where our $200M in cash goes. Just speculating, but maybe this is who has been buying Sammy's shares.

Now really speculating, maybe they have been reading our board and want to unlock the value of all of our hidden assets.

[Just the facts maam]

Lalwani, didn't want to answer anything about the extended shelf life of Corti 1 ml either, when asked by an analyst. Hopefully, it is tied to a larger announcement.

[dasgrunt]

makes you wonder why there hasn't been a press release for approval and launch of Sovuna

[Just the facts maam]

Correction, Easka I misread the earnout as being for 2023, it is to be paid out in 2024, though it was earned in Q4 of 2023. So we are probably looking at net income north of $7 million. Hard to say what revenue will but will likely be i figure it should be north of $128 million.

Stock Analysis have 6 analyst pegging revenue for the year at $486.09 million, $8 million above ANIP's top guidance of $478 million.

[Just the facts maam]

Easka, according to the Guggenheim presentation, Lalwani stated that by using guidance provided in Q3 release, ANIP should end the with over $200 million in cash. This means that they should add at least $7 million in net income, in spite of paying up to $25 million in Gross Profit Earn-outs.

According to the Q3 10-Q filing, there was a 100 % probability of paying the earnout in Q4 with an assumed 9%-13% discount. This equates to an earnout payment of $21.75 to $22.75 million.

Assuming ANIP’s margins and expenses were consistent with the last two quarter, in order for ANIP to generate a net income of $7 million, after paying the earnout, ANIP should report revenues of approximately $145 million for Q4.

This would be 24.46% higher than Q2 revenue. Lalwani's comments and guidance created a fear of revenue pullback which saw PPS drop from $63.64 (close the day before Q3 earnings release).

I expect Q4 earnings and 2024 guidance will put those concerns to bed and see PPS retrace to $63.64 and continue climbing above the current price target of $71.67.

JMHO

[Easka]

JTFM, Thanks for the detailed follow up. I believe they will end up 2024 at ~575M revenue after a couple of ER day upgrades along the way, IMO.

[Just the facts maam]

Easka, I had only seen it in their Career pages. Corti is approved for many indication, including eye related diseases. It looks like that is going to be their MO for Corti's growth. They expanded slowly into pulmonology and are now ramping up. I see ophthalmology related positions becoming available in the future. They are or have conducted phase two trial for Stevens Syndrome (dermatology), so I see that as a future expansion as well. The 1 ml vial may be a trigger for expansion into some other previously approved indications. Getting the J Code is important in getting physicians paid for administering the drug, this should open doors to its expanded use. It will be interesting to see how it get covered by various insurance providers. I believe they are or will working with Veeva to assess potential prescribers and how many positions are justified.

It appears that Guggenheim estimated peak sales of Corti at $300 million. However, Lalwani, without giving an estimate for peak sales did indicate that they look to bring prescription back to peak levels. The $300 million estimate does not appear to include Acute Gouty Arthritis or Ophthalmology let alone other indications that could benefit from a 1 ml vial.

The following is why I believe they will beat analyst revenue estimates. Lalwani added that ANIP is set to continuously generate cash and are not relying on a deal to drive growth. Though any deal will add revenue immediately with at least 7 years of IP , not a product under development. With cash on hand of over $200 million for the full year. He did not say how much over but that would give them net income of at least $7 million and that is in spite of paying out Samy and company for the Product development-based milestone payments approx. $20 million), which according to Q3 's 10-Q filing stated they expect to pay out in 2024.

Analyst consensus for 2024 revenue is $501.09 million, I believe guidance will come out at $525 to $550 million, with quarterly upgrades throughout the year.

JMHO.

[Easka]

Agree the Revenue estimates for 2024 are low. Just listened to Nikhil's latest chat with Guggenheim, nothing new really except he may have signaled that the M & A may be a little further out than I anticipated. My thought, maybe a delay in current negotiations, or a target wanted too much for their business. He says now "a deal sometime in 24" He doesn't want to overpay.
Interesting i was just looking at job openings also, I think there are a total of 37 openings, including Acct Execs. One was for Associate Dir Marketing, listed under job roll was this; Associate Director / Director, Marketing will be responsible for our efforts launching into the Ophthalmology market and either the Rheumatology or Neurology market, depending on skill set and interest. This position is a unique opportunity for any marketing leader looking to break new ground as we continue to build the marketing function at ANI.

Corti launching for Ophthalmology? I don't believe I have heard them mention this before. Have you?

[Just the facts maam]

ANIP will announce earning February 29th. With 14 Clinical Account Executive positions available, I expect they have acquired another rare disease asset. ANIP's 2024 guidance should be significantly higher than the current consensus of $501 million in revenue.

Earnings

[Just the facts maam]

As I understand it, yes Easka.

[Easka]

Thanks for the post JTFM. The percentage numbers listed by each Company name, are they the percent Samy owns?

[Just the facts maam]

According to Samy's Executive Employment Agreement filed November 26, 2021, Samy's Outside Business interest and Engagements show that he has stake is the full integration of getting Novitium products ti market :

Nuray Chemicals Pvt. Ltd (42.5%) - API manufacturing facility located in Chennai, Tamil Nadu, India .
o Develops and manufactures various API’s for developed and rest of the world (ROW) markets

SThree Chemical Pvt. Ltd (98%) – Intermediate, API manufacturing facility located in Chennai, Tamil Nadu, India
o Develops and manufactures various intermediates for NuRay and API’s for developed and ROW markets

SaiMirra Innopharm Pvt. Ltd (33%) - Finished dose contract manufacturer that supplies ROW markets and PICS countries with prescription drugs, located in Chennai, Tamil Nadu, India

Delvin Formulations (33%) – Distributes various prescription products in India, located in Chennai, Tamil Nadu, India

Scitus Pharma Services Pvt. Ltd (40%) - Clinical research organization that conducts BA/BE studies for Novitium Pharma and other generic pharmaceutical companies. The facility is located in Chennai, Tamil Nadu, India

Samy Hotel (100%) - Hotel located in Tamil Nadu, India

Filing

Even Esjay Pharma LLC, the company owning the shares has been selling has the same address and phone number as Novitium, 70 Lake Drive, East Windsor NJ and [phone].

Hard to believe that Novitium doesn't have first right of refusal for any of Nuray Chemicals products and IP. Which bodes well for its future pipeline.

[silvr_surfr]

What a great thing this would be JTFM. This is a wonderful application of the product. I hope this happens.

[Just the facts maam]

Silvr, I would not be surprised if he advocates for an ANIP/Pfizer partnership to provide global access to Sovuna, at a minimum, to treat children for malaria. This fits nicely into his new position. The global market for Hydroxychloroquine is expected to grow to $5.6 billion by 2032. Obviously the margins would be lower, but volumes could be large.

Hydroxychloroquine Market

[silvr_surfr]

Thank you JTFM. I guess I wasn't paying attention or there has just been so much turnover across the directors. Regardless. I hope the Pfizer relationship goes somewhere. I believe they are a large API supplier of testosterone in the US.

[Just the facts maam]

ANIP's Director, J. Leonard Matthew, R.Ph., joined Pfizer in December 2023, as Senior Vice President, Global Access and Value, where he is accountable for leading affordable and sustainable access for patients globally across the Pfizer portfolio. It will be interesting to see if ANIP forges a relationship with Pfizer.

Matthew

[Just the facts maam]

ANIP picked up approval for Carboprost Tromethamine on January 25th.

Approval

[silvr_surfr]

Amazing day for them. This should well fund their pipeline and then some. I suppose NDAs could prevent them from discussing any relationship. At $2B valuation, each 1% equity stake is $20M. That will have to leave a mark on the balance sheet.

[Just the facts maam]

Closing at $37.17,Market cap over $2 billion. I agree that they will have to include the value of their balance sheet.

[silvr_surfr]

Double wow. CGON finally opened at $29 with 20M shares to be sold. Trading now at $31.

When will we hear from our management team of our stake (equity and/or royalty) in this IPO? CGON now well eclipses ANIP market cap. Go figure. We can't forget the pioneer Cell Genesys team that actually invented it and got no stock market reward, while the late comers are at Nasdaq ringing the opening bell for an upsized IPO.