ANI Pharmaceuticals Inc (ANIP) Quote

Good point, Silvr.

Yes, it would be great. Since you opened the door, one of my thoughts was now having a UK operations where there is an established testosterone market with no approved product.

Just dawned on me. Though the NDA application is likely for terazosin. It would be amazing if ANIP decided to file for female testosterone themselves.

Silvr, regarding global sales, I haven't been able to locate a liquid terazosin application ex-US. All I found was the original application in India by Novitium.

Thanks JTFM. Demographics are definitely in our favor for a liquid product.

Regarding the 505(b)(2) filing, if it is for a liquid for of terazosin. From what I can tell, it would be for the first liquid form of an alpha 1 blocker. According to Prophecy Market Insights the global Alpha Blockers market is estimated to go from $43.3 billion in 2024 to $66.3 billion in 2034. Though terazosin is a small player in the Alpha Blocker market that could change if it becomes the standard for geriatrics and hospitalized patients According to the patent application the inventors were surprised by the dicovery.

Hard to believe that it won't attract a lot of attention from a large pharma like Merck who include cardio-metabolic disorders as an area of focus.

Alpha Blocker Market

Many balls in the air.

Silvr, I believe they could get by fine on executing their current portfolio and that may be their plan. But the remaining authorized shares is very small compared to their peers. Fine if you are getting bought out, and makes it easier to defend from a hostile takeover. It is less appealing if you don't have enough shares to take advantage of a great deal which is accretive to share holders. They talked about Alimera giving them an initial footprint outside the US, this may be the next area of expansion.

Personally, I am hoping the low authorized shares is to eventually provide investor with high dividends.

JMHO

I get your point now JTFM. That is a lot of capital to work with. On one hand, it is good to be prepared, but, on the other hand, can't we just execute well on the current, expanded scope of work?

5.816 million authorized shares left to play with. FYI, they registered 3.07 million shares for the Novitium deal. One or two large deals could eat up much of the remaining authorized share. Unless they no longer need equity financing for business development. I still they will have to issue shares to ensure liquidity as they grow into a small cap company and when the credit rating is increased to investment grade.

JMHO

Silver, when combined with the outstanding shares, ANIP only has 5.816

Silver, when combined with the outstanding shares, ANIP only has 5.816

Thanks JTFM. Could this just be related to the acquisition of Alimera with more executives and higher growth expectations? It is a big increase and we need to see growth well beyond the growth in shares.

In ANIP's S-8 filing they amended the 2022 Stock Incentive plan registering 1.61 million shares allowing them to issue up to 6.51 million shares to employees, a 32.86 % increase over the 4.9 million shares authorized to be issued under the plan in their 2023 amendment to the 2022 Stock Incentive plan. In 2023, they increased the share authorized to be issued by 750,000 going from the 4.15 million shares authorized in the 2022 plan to 4.9 million, an 18.07 % increase over 2022.

Seems like a big jump. It makes me wonder if ANIP is working on another merger, where part of the inducement is an award of shares similar to the deal with Novitium.

Yay for our team! Will ANIP see it through to the end or settle? Last I checked, CGON had $0.5B in cash on hand.

Sounds like another great opportunity JTFM!

Wow, what a great add on JTFM and a rare disease product to boot. Just think about what we can do with this both domestically and internationally with our team versus the current competitor.

Thank you JTFM. Well, we know there is a definite end to this story at some point. Just don't know if it means money in our pocket or not.

CG Oncology's motion to stay discovery was denied today.

Silvr, if the 505(b)(2) filing is for a liquid terazosin, it would be the first FDA approve liquid Alpha1 blocker, which could syphon sales from the other Alpha blockers in addition to terazosin. We should see a PPS pop when announced and a big pop if approved. According to the patent it look like it would benefit hospitals looking for rapid absorption and patients having difficulty swallowing. Ten percent of Terazosin prescriptions in 2021 would be approximately 173,000 prescriptions. However, if it attracts from other Alpha 1 blockers at a 10% rate (2021 stats), it would be approx. 3.5 million prescription. I imaging the price would be much more than the tablets or capsules now available as generics.

It makes it very interesting that Samy was selling shares knowing that this filing was in the works. Obviously he needed the money. Mostly likely to fund Esjay's expansion.

This could be huge.

Novitium picked got approval for the fist generic L-Glutamine (Endari) Oral for solution. Used to treat sickle cell disease. Marketing exclusivity for Emmaus Life Sciences expired July 7th. Novitium Got approval on July 8th.

It is a rare disease drug which Emmaus reported having sales of $29.57 million with Gross profit of $28.26 million. Endari was their only product. Upon losing exclusivity in the US. it looks like they are working towards expanding international sales. They are small unprofitable company.

It will be interesting how ANIP manages in creating revenue.

Looks like ANIP escaped the most recent round of FDA Pre-Notices for Potential Noncompliance for not submitting results. Maybe next quarter.

I agree but I think we are store coming years of excitement. ANIP's revenue and profit margins are due to increase at an accelerated pace.

ANIP currently has a profit margin of 6.56 % on 517.46 million (TTM). I figure it will closer to a profit margin of 22.33% on revenue over $950 million by 2028 increasing to a profit margin of 27% on revenue $1.13 billion by 2031. None of this includes royalties from CG Oncology or any revenue related to Libigel.

It has taken a while but the long awaited run looks imminent.

JMHO

Excellent JTFM. The coming year should be exciting.

With all the focus of discussion surrounding the CG Oncology litigation. I overlooked the following in ANIP Q1 10-Q filing.

Research and development expenses increased from $5.9 million to $10.5 million, an increase of $4.6 million or 77.4%, primarily due to expenses related to a FDA filing fee for a 505(b)(2) for one product of approximately $2.0 million, and a higher level of activity associated with ongoing and new projects in the three months ended March 31, 2024.

No mention of it whatsoever in the press release or the in the earnings related conference call.

It is likely for the first FDA approved Oral Liquid Composition Of Terazosin, which is the first patent Novitium received and is patent protected to February 1, 2041.

Maybe ANIP is waiting for confirmation of FDA acceptance of the application before announcing it, which they should have by now.

If all goes well, it should be approved in 2024 Q4 or 2025 Q1.

Obviously, this not calculated into ANIP's current PPS.

I believe the $105 million revenue guidance from Alimera may be low.

According to their ]earnings CC in May

We continue to see growing utilization in the U.K., Portugal, Ireland, Spain and France. In March, the U.K. National Institute for Health and Care Excellence, or NICE, issued final guidance stating that the fluocinolone intravitreal implant is recommended for treating visual impairment caused by chronic diabetic macular edema irrespective of lens sight.

What this means for us is that now faking patients or those that have a natural lens now have access to ILUVIEN. NICE reimbursement to-date has been limited to only pseudophakic patients or those that had undergone cataract surgery. This is a significant expansion of our potential user base among the chronic diabetic macular edema or DME patient population. According to the U.K. Macular Society, safety patients represent up to 75% of the broader DME population in the United Kingdom. We expect the availability of this wider reimbursement to positively impact utilization in the U.K. in the second-half of 2024.

NICE guidance can also impact reimbursement in other countries such as Spain and Italy. We believe that this NICE decision if adopted in other markets will broaden our potential patient base in these countries as well..

The CEO was reluctant to provide analyst with guidance on sales increases due to the NICE reimbursement update, stating that they would need a couple of quarters to gauge the uptake.

It explains the head count expansion in the UK.

I also liked the following from the CC

For YUTIQ, our sales team now have the three year data from the YUTIQ PIVOTAL 001 study that illustrates the benefit of long-term control for chronic non-infectious uveitis affecting the posterior segment of the eye. It shows that the median time to the first recurrence of uveitis is over 1,000 days for the YUTIQ patient, while it's less than 100 days for the same patient, a substantial benefit

Longer term I like that they are collaborating on a trial titled

Intravitreal Faricimab Injections or Fluocinolone Acetonide (0.19 mg) Intravitreal Implants vs Observation for Prevention of VA Loss Due to Radiation Retinopathy (AL)

A phase 3 trial where Genentech is also collaborating. Primary Completion date is 2026-11-26 with study completion date two years later.

The study plans to include 600 patients with primary choroidal melanoma seeing in treatment with plaque brachytherapy. Over 40% of radiation retinopathy patients have been shown to experience the devastating vision loss associated with radiation retinol within three years of treatment. And currently, there are no FDA approved pharmacotherapies for radiation retinopathy.

Esaka, I believe they are lawyers from the state. They are acting on behalf of the big guns who will guide the legal stategy. Lead lawyer for ANIP appears to be James W. Dabney who is a retired retired Hughes Hubbard & Reed partner who is now an adjunct professor at Cornell Law.

Biography

James W. Dabney formerly headed the intellectual property and technology practice of, and is a retired partner in, Hughes Hubbard & Reed LLP. His litigation experiences include jury trials, administrative proceedings, arbitrations, appeals, and four successful Supreme Court appearances including TC Heartland LLC v. Kraft Foods Group Brands LLC, 581 U.S. 258 (2017) and KSR International Co. v. Teleflex Inc., 550 U.S 398 (2007). He is the author of KSR: It Was Not a Ghost, 24 Santa Clara Computer & High Tech. L.J. 131 (2007), and is also the sole named inventor of U.S. Patent No. 7,653,591 B1 entitled "Late Fee Avoidance System."

Mr. Dabney is a Life Member of the American Law Institute. He has lectured on patent law to professional audiences throughout the United States and in Europe and Asia, including at the European Patent Office and the Korean Intellectual Property Office.

His Biography

I like the fact that he has successfully argued before the Supreme Court on four cases. I believe that this case might end up there, as well, in order to protect biopharma inventors where 20 year patent of protection is often insufficient considering the time it takes to get a drug approved.

CG Oncology lead lawyer is likely David J. Farber a Partner with FDA and Life Sciences at King & Spalding

David J Farber

Silvr, Thanks for the post. I am not a lawyer, but one thing seems Very odd to me; the lawyers for both the plaintiff, Michael J Farnan and the defendant, Kelly E Farnan have the same last name? Both for from law firms from Wilmington DE.

Thanks JTFM. That is what I was thinking too but was not sure. It sure looks like they are vigorously defending the agreement. I like that they brought in SImes who actually structured the deal and that they are subpoenaing the people who helped put the IPO together. I t sure seems like they should have called this out in the transaction. Maybe they did which is what we will see in discovery.

I see ALIM is expanding their head count by 20 in the UK and Ireland and by 10 in Germany. A head count increase of almost 20%.

ALIM Jobs

Thanks Silvr, looks like CG Oncology is really trying to avoid discovery and withholding requested documents. It will be interesting to see how CG Oncology and ANIP update their shareholders.

Sorry it was Morgan Stanley not Merrill Lynch.

Hi, any attorneys out there who can decipher what's happening in the CG Oncology lawsuit? Here's is what I am able to discern, but there are many motions and service items that I cannot:

- CG Oncology lost their motion to stay discovery
- Stephen Simes submitted an affidavit on our behalf
- We subpoenaed Goldman Sachs and Merril Lynch who were both a part of the CG Oncology IPO

CG0070 Lawsuit

Happy INDEPENDENCE DAY, one and all. Seems we may be getting it back, lol

Silvr and Bagel, I remember the market manipulators holding ANIP's PPS in the mid $20's when they let it go it ran up to mid $70s. I expect a similar run eventually, taking us to between $150 and $180, a price where they may be willing to retail investors back in the game.

The growth and prospects should truly command a higher share price. I don't fully understand all of the tactics of manipulation. Dark pools are especially troublesome where it appears transactions can be parked for later use. This completely destroys the supply/demand thesis. I have read how the algorithms play on the emotions of retail. That is how it feels right now where the price can never seem to break $70. The algorithms are designed to get people to capitulate.

I don't have data, but it always seems like the share price is attacked prior to earnings to accumulate shares. I will look at this to see if there is not a trading strategy that could be deployed.

ANIP share price is treated better than many pharma companies but worse than others and the ALIM deal has yet to close. With such a low share total PPS can be moved up and down rather easily. One problem is that it is still lightly covered. A lot of outdated investment information on ANIP is out there with no reference to their focus on rare disease. With only 33.33 million shares authorized, I believe they don't want heavy coverage, yet. Lack of liquidity could force them to issue shares prematurely. ANIP's MO is to under promise and overdeliver. I don't expect this to change. Once profits exceed what they need for business development, one way to counter the market manipulation is by returning shareholder value in the form of a dividend. It has no bearing on share price and takes the ball out of the hands of market manipulators. Though ANIP's Annual report indicates they do not intend to issue dividends for the foreseeable future. This is especially true, if they intend to expand globally.

ANIP has proven prudent in its acquisitions. Gilead paid 6.6 times peak sales for Cyma Bay and Abbvie paid 5 times peak sales for ImmunoGen. In fairness both companies have longer IP protection. In S&P 's analysis they believe peak sales of $200 million for ALIM's Iluvien an Yutiq, though a number of analyst believe it to be higher. S&P believe that they unlikely to face generic competition due to cost of trials and complexities in developing and manufacturing these drugs, which is almost as good as IP protection. The $381 million deal at 1.9 times peak sales seem like a bargain. Additionally, S&P upgraded ANIP to BB following the deal. This should reduce the cost of borrowing somewhat.

S&P Global ANIP/ALIM deal

The Corti and Novitium deals show that ANIP is good at generating value through their business development, I am certain the ALIM deal will be just as good for ANIP.

As always, we are the mercy of the market manipulators, for the time being.

JMHO

why is this stock not at 85 by now????

Thanks BB.

They launched it today as well. U.S. annual sales for Naproxen Delayed-Release Tablets total approximately $36.7 million, based on April 2024 moving annual total (MAT) IQVIA data.

PR from ANIP sight

North, nothing else on this at Merrill. Caught my eye because I take Naproxen, lol.

Interesting…..any idea how soon ANIP will market that generic?

08:09 AM EDT, 07/02/2024-- ANI Pharmaceuticals said Tuesday that the US Food and Drug Administration has approved its abbreviated new drug application for its Naproxen delayed-release tablets, a generic version of EC-Naprosyn. Naproxen is a nonsteroidal anti-inflammatory drug used to treat pain or inflammation. US annual sales for Naproxen...

I believe so, Silvr.

I checked out the authorized shares for US Pharmas with a market cap exceeding $1 billion.

ANIP had the lowest at 33.33 million shares followed by :

LGND had 60 million shares
PTGX had 90 million shares

The rest had authorized 100 million shares or more.

As it stands ANIP will not be splitting their stock as it gets more expensive.
It is unlikely that they will use equity in any future deal unless the share price climbs considerably.
Another reverse split could be used down the road to free shares for a deal. This would make ANIP shares even pricier and out of reach for most retail investors.
If ALIM deal generates returns as expected and the CGON and Libigel royalties kick in, I expect they will be flush with cash and will not require much in the way of equity financing to fund growth.

Personnally, I hope the goal is not to sell ANIP, but to create a company that eventually pays high dividends.

Wouldn't tthis be one of the reasons why MVP Capital has stuck with the company for so long too?

Just noticed that when Biosante led by Simes did their reverse split in June of 2012. They took down the authorized shares from 200 million to 33.33 million, as well. Very odd for a company trying to survive. This is very small for the pharma industry. Often the reverse split only applies to the outstanding shares. When the reverse split on 2013 occurred after the merger with ANI, only the outstanding shares were affected. As of Q1 release over 64% of the authorized shares have been issued.

Even though ANIP is an acquisition company, it looks like the merger between ANIP and Biosante was forged with the intent of it being sold and by keeping a low share volume, it is easier to maintain a controlling interest.

Any increase in authorized shares requires shareholder approval. No one will authorize this unless there a deal on the table that is compelling to investors.

If Anip is not being bought out within the next 3 to 5 years, I see ANIP using cash to buy back shares to be used for larger deals in the future.

JMHO

How Ampersand fits in is a good question. Their portfolio is broad and many could help ANIP at some point.

Excellent thesis JTFM. You have to like the entrepreneurial spirit of the team. We have not talked about our chairman, Patrick Walsh, and the Ampersand Capital connection of late. Where does this fit in with all of the other catalysts?

For anyone concerned about Samy selling shares for Esjay Pharma LLC, Esjay Phrama LLC operates out of Novitiums location in East New Jersey. NOVITIUM LABS PRIVATE LIMITED had two directors listed Samy and Ayyavu Rajavel. Rajavel is also a director for Esjay Pharma Private Ltd headquartered in India. Esjay Pharma Private Ltd. manufactures injectable.

Esjay Pharma Private Ltd

Esjay Pharma Private Ltd was incorporated September 30, 2022 and Samy (Esjay) started selling shares June 20, 2023.

Esjay Pharma Pvt Ltd Manufacturing

I believe that SAMY is setting up Injectable manufacturing capabilities at the Novitium location for Corti, Iluvien and Yutiq and future products.

Thanks North. Never ceases to amaze me at how many ways exist to manipulate the markets.

If I am reading this correctly there was bit of a tell in the Alimera presentation that ANIP existing pipeline is on track for a significant increase in guidance.

Potential for substantial shareholder value creation
? Expected high single-digit to low double-digit accretion in 2025 adjusted non-GAAP EPS and substantially accretive thereafter
? Anticipated additional $35-$38 million in 2025 adjusted non-GAAP EBITDA inclusive of approximately $10 million in identified
cost synergies; incremental EBITDA contribution expected from accelerated growth of Cortrophin Gel within ophthalmology
? Anticipated 3.2x(1) pro-forma leverage upon close; expect to significantly de-lever organically in 2025

ANIP's Net Debt stood a $47.21 million in Q1. Tthe deal cost $381 million, $280 in debt financing and the rest coming ANIP's cash.

Since the deal is closing in Q3 and at close they are looking at ANIP having a 3.2 pro-forma leverage. If ANIP did not add to their coffer in Q2 ANIP and ALIM combined EBITDA would be $40.11 million for Q2. Alimera had $9.6 million in EBITDA over the last three quarters. ANIP has a 21.72% EBITDA margin (TMM) , While ALIM has had a 7% EBITDA margin since acquiring Yutiq.

However, likely reduced their net debt somewhat lowering the combined EBITDA for the quarter. I would not be surprised if ANIP reports at least $150 million in revenue for Q2.

JMHO