Just the facts maam
1 week ago
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.
Just the facts maam
2 weeks ago
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.
Just the facts maam
2 weeks ago
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.
Just the facts maam
2 weeks ago
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.
Just the facts maam
2 weeks ago
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
Just the facts maam
3 weeks ago
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
Just the facts maam
3 weeks ago
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