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Thanks auh2oman. I believe Q2 earnings will show Acth unit sales will continue showing year over year growth that it has shown since June 2022. ANIP's Corporate presentations shows that Aprils unit sales grew 25% over April 2022. With Mallinckrodt looking at a second bankruptcy filing, I believe you will see more of the increased sales coming to Corti over Acthar. This should help ANIP beat revenue and EPS estimates.
Analyst are estimating Q2 revenue 97.49M and EPS of $0.66, which, no doubt, is due to the guidance provided by ANIP. ANIP's revenue has grown at a 13% to 14% Quarter over Quarter rate over the last 4 quarters. I expect they will have another solid beating of revenue and EPS estimates for Q2. Hopefully they can keep the pace of growth going. If so, we will see another upward guidance and a big PPS pop upon earnings release. This could be further fueled by an announcement regarding the use of proceeds from the most recent offering.
GLTA
BB, on Friday the volume was 510,000 shares which was on par with the institutional rebalancing on June 16th, where volume was 535,000 shares. There were no announcements on Friday.
It makes me wonder if they made an 505(b)2 NDA filing for oral liquid form of Terazosin. I imagine they would not make any announcement until it is accepted and a PDUFA date has been assigned. It would fit within a timeline of 2024 launch as projected in their SEC filings.
Just speculating.
BB, with a 35% increases PPS over the most recent offering price of $39.50, it looks like institutions are finally ready to let it run.
Oh Well! CVRs are no more. Hopefully that will accelerate the advancement of testosterone.
Easka, Sammy has his fingerprint on a number of businesses. He likely needs the funds for investment in his other businesses.
Looks like he is also selling his place at 16732 Strasbourg Ln, Delray Beach, FL for $2.14 million. This address was listed for as Esjay LLC in the merger filings, which is third largest shareholder behind MVP and BlackRock.
For sale
i2023 FLORIDA LIMITED LIABILITY COMPANY ANNUAL REPORT
Looks like ANIP will be supplying Australia with Misoprostol tablets.
Temporary approval
Thanks BB same with you and your family.
Good to hear Silvr. But 61% not completing the trial was a high rate. Unlike,, Libigel which had a much higher retention rate. I think we might about Libigel this weekend, but I doubt it.
The fact it has been held quiet for so long, is consistent with it being part of a bigger announcement.
Silvr, seeing that the largest portion of the patient population suffered from Hypertension and the Executive Committee was chaired by Dr. William White, president of the American Society of Hypertension in 2012 and had a former president Dr. Henry Black on the Data Monitoring Committee, it is possible that the findings will be released at the Hypertension 2023 Scientific Sessions, which will be held September 7-10, 2023, in Boston, MA
In any event, I think Small Cap Pharma companies are in for a run after being undervalued for the last couple of years.
Looking at other pharma. Looks like big money is plowing into undervalued small cap pharma stocks, ANIP is not alone. I see that EGRX and SUPN had a big volume day as well.
Silvr, something triggered 611,330 shares being traded at closing. And over 47,000 shares after hours.
I think ANIP gets a big pop next week.
Since Oral Liquid Terazosin was the first patent received Novitium, I expect it will be the first 505(b)(2) NDA filing. If so, according to ClinCal.com data, in 2020, the top 5 Alpha Blockers sold over 32.72 million prescriptions in the US, generating over $1.58 billion in sales. None of them had an oral solution. If this is what they tackle first and start paying earnouts in 2024, as indicated in their SEC filings, I expect they will pay out the full earnouts way before 2029.
ANIP's short interest is now down to 255,618 shares. Looks like the long awaited run has started.
Thanks Silvr. Could make things interesting.
Makes sense.
Excellent info Silvr.
Silvr, I agree not much was learned. Nice to see an increase of over 25% in ACTH prescriptions for April over 2022. Especially with MNK projecting a decrease in Acthar revenue of between 15% and 20%. . I think we will see another guidance upgrade in August.
No doubt. But they have a long way to go with Androfeme to catch up with Libigel.
Good to see PPS has tracked back to the initial offering $50 /share offering of November 2021. Should be continuing grow for a while.
Silvr, I think you are right. I would not be surprised to see that testosterone restoration lowered hypertension. It will be interesting to see what result come from the approximately 400 women in the trial who were on stable dose of estrogen.
On a side note. ABBV's PPS has been taking a beating this year. Assuming they are taking the lead and the findings are positive, I bet they can't wait for the scientific meetings to reverse this trend.
Not if you own MNK or work there. But it should be good for ANIP. The uncertainty may have more Corti prescriptions heading ANIP's way.
Silvr, just a thought, since the CV patent prosecution was rebuffed by assigning prior art to Dudley's invention. I wonder if, AbbVie decided to wait, as long as they can, before filing a patent using the USPTO's own assignment of prior art to Dudley (owned by AbbVie) with ANIP's examples, in their filing. This strategy would give them a level of certainty that it would be allowed with the maximum amount of patent protection possible.
Apparently not all patent applications have to be published. If a request is made not to publish the patent application, you can shield your invention from the competition, but anything new that is introduced cannot be considered prior art. The CV claim's prior art already seems to be established and the breast cancer claim's prior art was set on December 19, 2015. It makes me wonder if there is an unpublished one or more patent applications in the works.
I agree, it is not pleasant seeing what it does to those you love.
The scientific statement could be very interesting.
Silvr, more evidence that female testosterone may be bigger than we expected. Trial results suggest genetically predicted higher total testosterone may lower risk of Alzheimer’s disease. The role of testosterone and the immune system in Alzheimer’s disease could be further investigated.
The influence of growth and sex hormones on risk of alzheimer’s disease: a mendelian randomization study
ANIP posted openings for Production Operators for all shift last week. Looks like they are preparing for increased volumes
Akorn auction? Something related proceeds from the offering?
Thanks Silvr. Just a matter of time.
Dr Snabes is 74 years of age, I am pretty sure getting female testosterone across the finish line keeps him going.
Silvr, Thanks for reminding me about Dr. Goldstein's clip on Libgel. He says that Dr. Snabes says if the FDA want 10 years of data, we will give them 10 year of data. You can see he was more excited about it reducing the risk of CV events than treating HSDD. He had to be careful on what he could disclose.
June 6, 2011 BPAX updated the clinical trial sating that it was active but no longer recruiting with 3,656 participants enrolled.
Approximately 5 months after the last participant would have completed 10 years in the study, it looks like a Certification request is submitted.
What Is LibiGel? - Dr. Goldstein
If we are right about this, it must be bigger than we even imagined, given all the secrecy.
Silvr, speaking of testosterone, I was looking at AbbVie's board on Cafepharma , and normally I take much of what is posted with a grain of a salt, but I found it interesting as posters were complaining about AbbVie's lack of R&D. They posted that internally AbbVie has been telling their employees that hey have a plan to combat Humira LOE for the last 10 years. Allergan obviously was not the original Plan as they tried to acquire Shire before that. They believe the existing plan won't cut it. Started about the same time they hired Dr Snabes. If this is the case, there is internal pressure building for them to come out publicly.
FYI, Pfizer's patent protection for Tafamidis-Meglumine (Vyndaqel) expires April 27, 2024.
Pfizer Patents
Slivr, hopefully so. I agree ANI's stake in CG oncology has been diuted but it does look like ANIP may get milestone and royalty payments.
Thanks Silvr, since it is an open label trial, I expect there will some interesting preliminary data coming out in 2024.
Auh2oman, upon looking at what has transpired over the last 10 years, I believe the CVR were tied to ANIP getting the CV related patent. In the end, they did not get the patent and the CVRs likely stifled activity until they expire. A full pay out is at the expense of all shareholders and MVP's position would have absorbed over $12 million of the payout.
One month to go.
Looks like the new shares added some needed liquidity. Hopefully the start of a long upward trend.
GLTA
I agree, they look dead.
I agree, they look dead.
It could also be for filing the 505(b)(2) NDA's and getting ready for commercialization. Filings show that they expect to start paying earnout payment next year. I would agree thar CVR's are dead . It benefits Sammy and MVP greatly to have them expire.
Silvr, here is an interesting study for Androgel. Hopefully it is effective.
Effects of Early Testosterone Gel administration on Physical Performance in the Critically Ill (TestICUs)
Novitium picked up approval for DEXAMETHASONE.
Approval
Dasgrunt, looks like offering proceeds are not meant for Akorn Assets.
Easka, I agree it has been crazy.
Dasgrunt, could be multiple activities.