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I watched the price fluctuate at opening. It dropped 25% on 16k shares in a minute or two. We closed the day breaking 1 million shares traded with an 18% drop over the next 7 hours. Trying to recall our run up to $60 last year, I don't remember volume reaching that point? But I do recall we were there for a brief moment before it was brought lower in days. I don't necessarily believe the ER warrants a 20% drop in total market value. I really hate how retail is constantly at the will of the market makers and betting against algorithms.
I suspect this was a reactionary event taking advantage of the news to grow or feed a short position.
-RG
Great Find! This is a big deal if they pursue this direction (I think even more valuable than testosterone therapy over the long run).
Consistent volume despite the market "correction"...I really hate betting against algorithms.
-RG
Another collaboration:
Oakrum Pharma and ANI Pharmaceuticals Announce the Launch of Betaine Anhydrous Powder, the first Generic Version of Cystadane® (betaine anhydrous for oral solution) Powder, Including 180 Days of Exclusivity
February 14 2022 - 05:00PM
PR Newswire (US)
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SAINT LOUIS, Feb. 14, 2022 /PRNewswire/ -- Oakrum Pharma, LLC ("Oakrum Pharma"), in collaboration with ANI Pharmaceuticals (NASDAQ: ANIP), announce that the U.S. Food and Drug Administration (FDA) has approved the Abbreviated New Drug Application (ANDA) for a generic version of Cystadane®1 (betaine anhydrous for oral solution) Powder in a 180 gm bottle and granted Competitive Generic Therapy (CGT) of 180 days of exclusivity. Shipments of the generic product began in early February, 2022.
Marco Polizzi, CEO of Oakrum Pharma, stated, "This is the third generic orphan drug that we have launched since starting this business, and we remain committed to bringing rare disease patients affordable options of pharmaceutical products that currently have few or no generic options. Oakrum currently has licensing rights to seven additional ANDAs filed with the FDA and expects to file additional generic orphan drugs later this year."
"Our collaboration with Oakrum furthers ANI's mission of bringing high-quality prescription pharmaceutical products to patients in need. Rare diseases are often overlooked, and we are especially pleased to continue identifying patient populations that are underserved and medicines that can help them. This approval with Competitive Generic Therapy status and resulting 180 days of exclusivity marks another milestone for ANI's R&D engine as a leader in bringing limited competition products to market," stated Nikhil Lalwani, CEO of ANI Pharmaceuticals.
1 Cystadane® is a licensed trademark of Recordati Rare Diseases Inc.
-RG
Triple the daily volume and we're up? More shenanigans or something else? Short interest still remains low. Several larger purchases sprinkled throughout the day.
-RG
The terms are synonymous as far as my experience goes, but Silver may add more to this conversation. The instrument used to detect and analyze the levels is specifically the Mass Spec. The eluate from the liquid chromatography is what's actually analyzed by the instrument so they go hand in hand.
-RG
This is good news. It's the small steps before the bigger stride. Thanks for sharing this info. In a past life, I depended on a Mass Spec for my research-the technology is amazing.
-RG
I literally contacted the company maybe 14 months ago regarding that drug and its value. I was frustrated they didn't market themselves more surrounding it to the point that I wasn't totally convinced they were aware of the research coming out of Israel. They replied very simply that they were aware.
It was a time where any whisper of a drug that could treat symptoms or reduce hospitalization would drive the stock up by 80-200%...but they didn't seem to respond with as much excitement as I had.
-RG
It's crazy- 3 extremely competitive drugs released in two days, short % lowest it's ever been (1.77%), and excluding all of the other positives over the past month, we're still trading sideways on this news.
-RG
another insider buy of 3000 at 42 and change.
-RG
2500 shares purchased at 39.38 byThomas Haughey. Is this a personal open market purchase or transferred under contract? I'm surprised no one has mentioned it?
-RG
They're closing around November 18th:
ANI Pharmaceuticals Receives Clearance from U.S. Federal Trade Commission for the Acquisition of Novitium Pharma
November 11 2021 - 06:50AM Business Wire
4 minutes
ANI Pharmaceuticals Receives Clearance from U.S. Federal Trade Commission for the Acquisition of Novitium Pharma
-- Divestiture Required by FTC of Two Generic Products Immaterial to Company’s Business --
ANI Pharmaceuticals, Inc. (Nasdaq: ANIP) (ANI or the Company) today announced that the U.S. Federal Trade Commission (the FTC) has accepted the proposed consent order in connection with ANI's definitive agreement to acquire Novitium Pharma. The divestitures required by the FTC of development rights to one generic drug and assets with respect to another generic drug are immaterial to the Company’s business.
The acceptance by the FTC satisfies all required antitrust clearances needed to be obtained for the acquisition of Novitium Pharma by ANI. The closing of the acquisition remains subject to other customary closing conditions set forth in the purchase agreement. ANI currently expects that the acquisition will be completed on or about November 18, 2021.
-RG
Short interest dropped to 4.32% from 4.8%
-RG
Thanks for sharing this information. As a result of those three major blows this past year, the board moved aggressively with involving Ampersand and getting Nikhil onboard. I have total trust in their decisions moving forward at this point, but I couldn't've said that a year ago.
With all of the expected announcements ahead of us, I'm hoping there's a window where we'll get to see some insider buying.
-RG
The offering is expected to take place November 8th. I'd presume they factored in the offering price while brokering the contract since it'll most likely take place after the 8th.
-RG
Offering 1.5M shares @$50.
ANI Pharmaceuticals, Inc. Announces Pricing of $75 Million Public Offering of Common Stock
November 03 2021 - 10:54PM
ANI Pharmaceuticals, Inc. (NASDAQ: ANIP) (“ANI” or the "Company") today announced the pricing of an underwritten public offering of 1,500,000 shares of its common stock at a public offering price of $50.00 per share. The gross proceeds of the offering to the Company are expected to be $75 million, before deducting the underwriting discounts and commissions and other offering expenses. In addition, ANI granted the underwriters a 30-day option to purchase up to an additional 225,000 shares of common stock at the public offering price, less underwriting discounts and commissions.
The closing of the offering is expected to occur on or about November 8, 2021, subject to the satisfaction of customary closing conditions.
Guggenheim Securities is acting as lead book-running manager for the offering. Raymond James is also acting as book-running manager for the offering. H.C. Wainwright & Co. is acting as lead manager for the offering.
-RG
Completely agree. It reads as though it's meant to secure the success of the assets we have/acquired ala Cortrophin and Novitium.
It's interesting because AniP's original website seemed like it was designed using a dialup modem. Since Nikhil, they hired the new PR firm and the site got a much needed upgrade. They released the Cortrophin website the other day which is really flash and looks as though they're paying much needed attention to the marketing component of the drug. But they're not a marketing company. I personally forget how fundamentally important that aspect is to the success of a drug.
I'm eager to find out what the public offering price will be as well, but expect to take a hit in the near future bc of the stigma behind the offering.
Point of fact: we're not in the process of going bankrupt. The funds are literally being used to grow the company.
-RG
That didn't take long...
ANI Pharmaceuticals, Inc. Announces Proposed Public Offering of Common Stock
ANI Pharmaceuticals, Inc. (NASDAQ: ANIP) (“ANI”) today announced that it intends to offer and sell shares of its common stock in an underwritten public offering. All of the shares to be sold in the offering will be offered by ANI. The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering. In addition, ANI intends to grant the underwriters a 30-day option to purchase up to an additional 15% of shares of its common stock offered in the public offering.
Guggenheim Securities is acting as book-running manager.
ANI anticipates using the net proceeds from the offering to fund its Cortrophin commercialization efforts, including, but not limited to, sales and marketing and consulting expenses related thereto, and for general corporate purposes. We may also use a portion of the net proceeds to in-license, acquire or invest in additional businesses, technologies, products or assets.
The securities described above are being offered by ANI pursuant to a shelf registration statement on Form S-3 (File No. 333-239771) which was initially filed by the Company with the Securities and Exchange Commission (the “SEC”) on July 9, 2020, and was declared effective by the SEC on July 17, 2020.
The securities will be offered only by means of a prospectus supplement and accompanying prospectus relating to the offering that form a part of the registration statement. A preliminary prospectus supplement and the accompanying prospectus relating to and describing the terms of the offering will be filed with the SEC and will be available on the SEC’s website at http://www.sec.gov. Copies of the final prospectus supplement, when available, and accompanying prospectus relating to the offering may be obtained from Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, New York, NY 10017, by telephone at (212) 518-9544, or by email at GSEquityProspectusDelivery@guggenheimpartners.com.
-RG
Truist initiated coverage of ANI Pharma with a rating of Buy and set a new price target of $70.00
-RG
The best thing to happen to this company is ousting the old CEO and bringing in Nikhil. At the time, I appreciated our growth as a generics company, but looking back, there was definitely a ceiling. Being relabeled as a biopharma with both branding and manufacturing is a game changer for AniP.
I also got into generics bc it's good for society. The way Nikhil speaks with respect to patient care is not something you can easily fake and I think the growth moving forward won't take away from that sentiment.
-RG
Raymond James set it at $60 in May 2021 which was the highest estimate at the time. The average is $45. We were sitting around $32 in May.
I can recall someone disparaging RJ on this board recently, but RJ hit the mark and asked really good questions during the earnings call. Can't wait to see where they set it now.
-RG
I suspect there will be another pop after the Novitium acquisition. Could be that some larger hedge funds are waiting for confirmation before jumping in.
Then another bump when Cortrophin hits the market.
Sprinkle in some insider purchasing and we'll all be sitting pretty heading into Q2...presuming the world economy doesn't collapse.
-RG
Oh...and libigel isn't even factored in any of this!!!
4.2 million shares traded...just amazing. I can't remember the last time we had volume like that. I mean, we were down 3% on Friday, and 6% premarket. I hope those 4.8% of shorts are getting burned on this.
Congrats everyone, and to the new arrivals, welcome, this ride isn't over by a long shot.
-RG
Third quarter 2021 net revenues of $52.1 million; net loss of $4.4 million and diluted loss per share of ($0.37) --
-- Third quarter adjusted non-GAAP EBITDA of $16.6 million and adjusted non-GAAP diluted earnings per share of $1.01 --
-- FDA approves supplemental new drug application for Purified Cortrophin™ Gel for the treatment of certain chronic autoimmune disorders; full-scale launch planned for early Q1 2022 --
-- Acquisition of Novitium Pharma LLC is expected to close in November 2021 --
-- Launched Nebivolol Tablets simultaneously from two manufacturing sites --
-RG
Early Q1 2022 full-scale launch planned --they are not messing around!
-RG
Great news! It went down 6% in premarket and I was worried, jumped 12% on the news premarket.
Still not sure about the updated labeling last Friday. Per the announcement:
Pregnancy: Since fetal abnormalities have been observed in animals, Cortrophin Gel should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Immunogenicity potential: Prolonged administration of Cortrophin Gel may increase the risk of hypersensitivity reactions. Neutralizing antibodies with chronic administration may lead to loss of endogenous ACTH and Cortrophin Gel activity.
Presume the trade label got updated based on the generic labeling and its subsequent approval under this most recent fda application.
Excited to hear what will be discussed during earnings.
-RG
I saw that, too, but the nda is under Mallinckrodt. There isn't any mention of the generic formulation or AniP which seems odd? The manufacturer's label was also updated (presumably today) with a date of 10/21 to include these changes:
RECENT MAJOR CHANGES---------------------------
Warnings and Precautions, Immunogenicity Potential (5.10) 10/2021
(Immunogenicity Potential: Neutralizing antibodies with chronic administration may lead to a loss of endogenous ACTH activity)
Warnings and Precautions, Use in Pregnancy (5.14) - removal 10/2021
The dose per this updated label is: 5 mL multi-dose vial containing 80 USP units per mL. Which I believe is both trade and generic formulation dosing, but JTFM, please correct me if I'm wrong.
The fact there's literally zero news on the subject available makes me wonder if Mallinckrodt adjusted the label to differentiate trade vs generic even more.
-RG
Playing the odds, this is good news.
Here's a copy and paste from an abstract on a study out of rutgers/stern:
This study examines the value relevance of the timing of earnings announcement dates relative to
prior expectations. It shows that when firms advance their earnings announcements at least four
days prior to expectations, the earnings surprises in those quarters tend to be positive and the
abnormal returns from two days after the earnings release date was announced through one day
after earnings are actually announced are positive and significant. The converse is true for firms
that delay their earnings announcement at least four days relative to prior expectations. The study
also shows that firms which delay their earnings release date at least four days after previously
setting the date earlier are characterized by both negative earnings surprises and abnormal
returns from the delay announcements through one day after the actual earnings announcement
date. These results can be used by investors to earn abnormal returns, by security analysts in
revising their forecasts, and by option traders when earnings announcement dates cross option
expiration dates...
...when the firm has a positive earnings surprise, it is more
likely to rush and disclose it early for several reasons. It can upstage similar good news by other
firms in the same industry, it can set the bar higher for other firms in the industry, it can attract
analysts' and institutional investors' attention, and it reduces the likelihood that a negative event
will occur (such as a natural disaster, regulatory investigation, revoking its license), which would
need to be disclosed with earnings, potentially harming the good earnings surprise. Thus, the
timing of the earnings disclosure can potentially signal the direction of the earnings surprise
-RG
Thanks for the reference. Presuming nothing has changed, which I suspect they would be obligated to announce if it had, that's one less concern.
-RG
Short interest dropped to 4.8% so I don't suspect many are betting against an approval.
RG
I suspect it's going to get delayed.
The FDA had previously reported back in August that a rise in volume of applications and travel limitations has slowed its review process. On time reviews have dropped from 98% in 2020 to 91% in 2021.
I'd love to eat these words, but given the manufacturing asset in Canada, and their borders having been closed, I wouldn't be surprised if it was delayed. I suppose it'll really depend on the details of the application. If any part of the process involves using manufacturing capabilities in Canada, then we may be waiting for the inspectors to get across the border.
To read this another way, don't grab pitchforks if it gets delayed.
-RG
No poll is needed. My aim is to reduce the clutter on this board, not add to it.
-RG
This board isn't policed. What it boils down to is mutual respect and consideration to the other members of this board, many of whom have actually been around after transitioning off the yahoo message boards.
We transitioned because many of those posts served no importance to the greater conversation, and many carried vitriol that had a way of leeching into the overall tone and quality of the board, biasing the DD in both content and value.
I speak for me and would much rather politely ask the political chatter be taken to another forum before triggering the block button.
-RG
Mitsubishi UFJ Asset Management (UK) Ltd. has a new stake in ANIP: 16k shares.
Link to the article
-RG
A friendly reminder that this is not the place to discuss politics. There are a myriad of other forums that are far more appropriate to carry out that sort of dialogue.
-RG
There are a lot of factors involved in reproducing/replicating any compound outside of academia. The compound itself can't be patented forever- hence the existence of the industry we are currently supporting (generics), but the process in making those compounds can be patented and licensed with variable expiry dates. The challenge of it all may truly be actually synthesizing the drug (but these ”recipes" are often available through scientific journals). What often slows the process is needing to make a drug without tapping into extraneous licensing costs, and in pharma, it includes anything from synthesizing the actual drug, or materials used, even storage (I've known patents placed on optimum temp ranges for refridgeration). Skies the limit.
So if someone were to offer a cake recipe but you'd need to pay the fee for whipping eggs with a whisk bc that part of the process was patented- you either need to pay the per application fee, or devise another way to mix eggs--this can often be the bottle neck- but once you figure out you can use a shaker bottle to the same effect, you tackle the next hurdle. These small subtle changes can alter the final product: will you make a cake, yes, of course, but taste/texture/density/appearance may be different...then viability comes into play.
Note that there are often cases drugs are licensed outright and mass produced, or sold (we are familiar with these arrangements). But with Corti, it's a little different.
-RG
Increased volume may include a lot of stop loss triggers. I honestly didn't think we'd be back in this direction. Goes to show how "free" the market truly is.
-RG
The short interest is at 4%, fairly low. Citadel joined the fray this year, and they are notorious for playing these kinds of games. But even with this said, we've been trading sideways for a year with extremely low volume. ANIP could do a lot to get this to spike, but they're playing their cards close to their chest. Pat's investment last year fluctuates a few points above and below his entry. Seeing more insider buys would be amazing to boost confidence, but barring that, just sit back and relax--neither the retailer, nor ANIP, are in the driver's seat.
-RG
PS. Stop yelling at us
Volumes at 25k at the time of posting- we need more interest. That's what will drive the price higher.
-RG
Haha- the ask is $100!
-RG