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Barron's lists ANIP as one of 20 stocks to own during the next bull market.
Crocs, United Airlines, and 18 Other Stocks for the Next Bull Market
Bagel, low PPS also affects insiders. I figure when ANIP starts generating serious cash, they will just start giving dividends, if PPS doesn't rise to appropriate levels. Insiders own more than 4.7 million shares.
With only 17.5 million shares, I am okay with that.
Silvr, a breakdown of the G&S for the trademark applications makes it look like they have more than one product in the pipe to be named.
Trademark for a
1 - pharmaceutical preparations for the treatment of oncological and cardiovascular diseases, hypertension, renal disorders and arthritis;
2 - Pharmaceutical preparations for the treatment of infectious diseases and auto-immune diseases,
With respect to terazosin, I have yet to find a use or trial where it was used for arthritis. If anything, arthritis is considered as a potential side effect.
Thanks Silvr. I wondered if the indications better suited testosterone or terazosin which they have patent protection until 2041.
On February 23, 2023, ANIP filed for trademark for a pharmaceutical preparations for the treatment of oncological and cardiovascular diseases, hypertension, renal disorders and arthritis; Pharmaceutical preparations for the treatment of infectious diseases and auto-immune diseases , which are being published for opposition on April 13.
SEZROA
OPFLAVA
TEZRULY
SOVUNA
Two other trademarks were submitted INZIRQO and OPFLOVA but neither has been submitted for opposition.
Trademarks
Looks like it was one of the four ANDAs acquired from Oakrum. In the PR ANIP stated they expected to launch in 2023.
PR
Oakrum appears to be a small company, according to their Linkedin account they had 10 or less employees.
BB, ANIP beat in both revenue and earnings , which is good. However, ANIP is still intentionally lowballing their guidance.
How else can you explain growing Corti guidance to between $80 and $90 million for 2023 and give a revenue guidance of between $360 and $385 million.
$360 million - $275 million (ANIP's non-corti 2022 revenue) = $85 million (mid point of corti estimates for 2023)
It puts out a potential lack in confidence in growing the rest of the business. Which is inconsistent with what they have been saying about Novitium's capabilities to grow revenues and outpace generic price erosion. Or their 10-k filing which shows that they still have a 95% probability of making the Product development-based milestone payments by 2024.
In addition, they expect to complete the Profit-based milestone payments between 2024 and 2029.
Mallinckrodt reported growing Acthar sales to $140.9 million in Q4 from $125.7 million in Q3. In their earnings CC, MNK is projecting a 10% reduction in Acthar sales in 2023 due to competition. They are also planning to launch a next generation self-delivery device for Acthar in 2024.
MNK earnings
Given ANIP's growth strategy, it looks promising. Gaining sales from MNK while growing the number of non-MNK clients.
Thanks auh2oman. Looking at ANIP's Commercial Opportunities, it looks like they may be having success on the East Coast. Especially, Florida and the Area Business Director - Pulmonology Division (East Coast) looks like the work is there to justify breaking Corti into divisions.
Positions
I guess we will find out in 9 days
BB, that they will announced earnings on March 9.
Earnings
Oops link did not work, Try this link
Hormone Replacement Therapy Market Size to Hit USD 53.9 Bn by 2030
Jeff, they obviously have their reasons,. We just don't see or understand it, yet.
Possible reasons could include one or more of the following:
1) The testosterone partner is taking intent on taking a stake in ANIP. ANIP would not try to drive up PPS during this period.
2) A partner is in control an NDA filing for testosterone and ANIP just has to sit on its hands until the announcements are made.
3) It could be part of a larger deal.
4) Waiting until the CVR's have expired.
5) Lower strike price in stock options being awarded.
In any event, I find it hard to believe that ANIP won't benefit in some way from the Libigel data. Especially in light of the projected growth in hormone therapy gong from $31 billion (2021) to $53.9 billion (2030) much of related to menopausal women.
https://ca.sports.yahoo.com/news/hormone-replacement-therapy-market-size-140000657.html" rel="nofollow" target="_blank" >Hormone Replacement Therapy Market Size to Hit USD 53.9 Bn by 2030
Jeff, I understand your point. But given my background I tend to look at what they do and not just what they say. The public facing part of the company, press releases, announcements etc.., is consistent with what are saying. However, the submission of Certification/Extension request to delay posting trial results is a "Big Tell", that they still have more to disclose publicly. They are now legally bound to post results by October 27 , 2023 (2 years after submission).
This is the score, as I understand it.
Legally, ANIP was not bound to post results, unless the trial continued beyond January 17, 2017 (which was never announced), where all trials must be posted within one year of the primary completion date, or they were trying to preserve the integrity of an ongoing trial (Which has never been announced). There is no ongoing trial that has been registered, which legally they would of had to register, by now.
This points to them (or a partner) filing a Certification request to delay the submission of results, which is requirement when an NDA has been filed or will be filed (which also has never been announced).
If the results are consistent, with the patent filings, regarding CV event and Breast cancer event reductions, it should drive share price significantly. Investors wanting in after it is announced, must be prepared to pay much more than the current price PPS.
As for pipeline updates, ANIP has yet to put out a drug development pipeline, yet we know that in addition to the behind the scenes activity regarding aforementioned female testosterone, on January 18, 2022, they received a patent for Stable Oral Liquid Composition of Terazosin with patent protection until February 1, 2041 which is obviously something the are developing. Yet, no announcement has ever been made about this either.
Patent
Clinical Trial Certification/Extension request to delay posting results
Thank Silvr, it looks like Lawley will be the competition, globally. I figure ANIP's safety data will make it the drug of choice by prescribers and PBMs.
I guess we should find out some time this years.
Silvr, looks like Female testosterone could fit with the FDA trend for approving some drugs.
Study: 10% of FDA approved drugs since 2018 had pivotal trials that missed primary endpoints
Yep, mid-June, 2023.
Silvr, with the following conferences, ISSWSH - International Society for the Study of Women's Sexual Health March 2, 2023 - March 5, 2023 in St. Louis, MI and ACC - American College of Cardiology - Annual Scientific Session & Expo March 4, 2023 - March 6, 2023 in New Orleans, LA, it could be a good week for maximum coverage relating to any announcements.
Thanks Silvr.
That is interesting, silvr. I don't think we will see an buyout for a while.
If ANIP had secured the CV related patent, then ANIP would likely already have been acquired. Therefore, I see a partnership with a 50/50 split of North American profits and ANIP getting a royalties on Ex-US sales. Unless a three way partnership has been established, then could see a three way distribution of North American profits and ANIP receiving ex-us global royalties from both Merck and AbbVie.
Takeda and Abbott formed TAP (Takeda Abbott Partnership) and was very lucrative for both companies between 1977 and 2008. It sure would be nice to see AbbVie, Merck and ANIP forms a spin off company to drive testosterone growth globally.
TAP
According the Merck's earnings CC, in the Q&A session, they are sitting a business development news that they will be sharing in the future.
I guess we will see, if ANIP hiring Elizabeth Powell from Merck was part of a bigger plan.
GLTA
Silvr, here is another systematic review which supports more studies needed to evaluate testosterone affect on cognitive performance.
Thanks Silvr.
Novitium entered into deal with Eton Pharmaceuticals to distribute a generic CARBAGLU (Carglumic Acid) with a 50% split of the profits
Eton Pharmaceuticals Announces Acquisition of Approved Orphan Drug Product Carglumic Acid
According to Eton's Q3 earnings conference call:
Sillvr, I think it may be a typo. They are reporting owning 1,983,237 shares this quarter. Last quarter they reported owning 1,925,102 shares. That works out to a 3.02% increase. They do own 11.4% of ANIPs outstanding shares,
Still better than selling shares.
Thanks Jeff.
Hope you and the family are doing well, also.
As for Corti, seeing that they are projecting between $15.9 and $20.9 million for Q4 it represents a 26% to 66% increase over Q3. When considering the additional head count and the lessons learned from the launch to now and assuming sales fall in the top half of guidance for the quarter, I believe they will achieve sales of between $120 million and $140 million. What may be more conservative. maybe $100 to $120 million. Still higher than what analyst are estimating.
Pure speculation, obviously
Dasgrunt, it looks like the first Novitium 505(b)(2) approval was for Hydroxychloroquine Sulfate tablets. While it is a tentative approval for L-GLUTAMINE which is an ANDA of Emmaus Medical Inc.'s Endari which has data Exclusivity until 07/07/2024.
The following is from the approval letter:
Thanks dasgrunt.
According to the Orange Book currently Terazosin Hydrochloride is only approved in capsule and tablet form. If approved, ANIP would be the only oral solution on the market. Hopefully Terazosin's success in potentially treating Parkinson's will continue to advance.
Parkinson's
Hi Jeff, good to see you are still hanging in there.
As for share price, When ANIP announced a $42 million spend to launch Corti, it spooked the markets with the fear of another round of financing being required. I believe that fear will be put to bed when Q4 earnings are released.
It is true that we have been speculating based on some facts. Obviously ANIP has its reasons for not laying everything out, yet.
There is no denying the fact that someone (ANIP, Snabes and AbbVie?) requested a delay to submit results in the large Libigel study and that unless the study primary completion date was extended to January 18, 2017 or later, there was no obligation to submit the results. Unless, of course, someone is applying for an NDA. Especially since no new study had been started, which would be justification for an extension request. So something hidden is definitely happening here. Why remains to be seen, But now they are now committed to submitting results by October 27, 2023.
There is no denying that Novitium had three 505(b)(2) NDA in the works, which was in ANIP's previous presentations. ANIP has yet to identify what they are. Though the Q3 10-Q filing clearly states that they estimate paying out the full $21.5 million earnout starting in 2023 and ending in 2029. The agreement clearly states that the earnout equates to 20% of net profit (defined in the agreement as: Gross profits less cost of sales and marketing) That works out to $107.5 million in net profits. They earnouts were suppose to run up to 10 years from approval for each drug, but they figure the full earnout will be paid by 2029.
There is no denying that :
- Novitum has a patent for a stable oral liquid composition of Terazosin which expires in 2041.
- Novitiun has one patent application pending for Hydrochlorithiazide Compositimons, if approved it will have a patent expiration of December 2041 or later.
It is highly likely that they are two of Novitium's 505(b)(2) drugs they are working on.
Most likely Terazosin will be the first of the three they figure will get approved this year (earnout payment projected to start this year)
So if they are not telling us about Terazosin, they obviously won't tell us about the other two 505(b)(2) drugs in the works.
If they needed more financing, I agree they should disclosing this info to boost share price. That is why I don't believe they need to raise financing. here are some reasons to keep pipeline quiet:
- A quiet period where a partner is accumulating a stake in the company prior to a testosterone announcement.
- ANIP is looking at another acquisition where lower PPS makes could have some tax advantage depending on how the deal is structured. Remember the BPAX and ANIP merger.
or, more concerning:
- They are trying to get more stock options before PPS takes off- (This would go to trust issue as you mentioned)
Personally I believe we will be above the $80, going into the summer. And that by the end of this year it will all make sense.
JMHO and GLTA.
Silvr. looks like Pfizer loses IP protection in 2026 in the EU. I can see a Merck partnership for the EU in 2026.
Pfizer Presentation. Slide 4 shows LOE
Silvr. looks like Pfizer loses IP protection in 2026 in the EU. I can see a Merck partnership for the EU in 2026.
Pfizer Presentation. Slide 4 shows LOE
Makes sense Silvr. Anyhow, at least one 505(b)(2) is expected this year, as they project starting earnout payments in 2023. I imagine it will be for a stable oral liquid composition of Terazosin.
Silvr, upon looking at, Vyndaquel's patent and data exclusivity it looks like all patents expire by 04/27/2024 however it has a patent term extension pending taking it's patent protection to 2028. All data exclusivity expires by 05/03/2026. Vyndamax on the other hand has one patent that expires in 2035, however, the rest of the patents and data exclusivity period are similar to Vyndaquel.
Sammy was listed first in their patent application, most likely the primary contributor to the invention. As one of the founding partners of Nuray Chemicals, it is difficult to believe that ANIP won't be the company that is licensed the rights to this patent. If so, ANIP should launch in 2028 maybe sooner depending on what patent data is used in their application. Nuray's patent describes a superior form of delivery over Vyndaquel. I imagine it will compete with generic competition, but in the end should be a more effective drug.
Sammy and Novitium might not even need this drug to reach his full earn-out, but it will definitely get them there by 2029, if not sooner.
In fairness to ART, from 2013 to 2018, he managed to find value and growth and not over pay for assets. Which a number of companies did during this period, and paid dearly when the FDA increased the rate of ANDA approvals and the purchasing consortiums squeeze the profits. The margins kept getting squeezed. He also acquired Corti, but was maybe over his head in getting it approved. That being said, Lalwani did have the benefit of a CRL to help get it across finish line.
NOTE: The full payout of $21.5 million would have have to come from $107.5 Million in net profits (not gross profits) from the 505(b)(2) approvals, alone. Not $1.075 billion.
Easka, Silvr, the full payout is generated from $107.5 million in net profits, not $1.05 billion. Sorry about the poor math.
Silvr, according to the Q3 filing, they are projecting the $21.5 million to be payed out between 2023 and 2029. Therefore the $1.075 billion in net profits should be generated within 7 years.
Then you have profits from:
Corti
Novitium's ANDA portfolio profits.
Royalties
And female testosterone.
ANIP could be a beast and just waking up.
Here's hoping.
Thanks Silvr, I have been trying to figure out why an analyst was estimating ANIP's EPS to grow from $6.74 in 2027 to $9:05 in 2028 (34.27%). This settlement explains it.