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Rhode Island's Neighborhood Health Plan is another Medicaid coverage that requires Corti be tried before Acthar be prescribed.
Criteria for approval
D. If the request is for Acthar Gel, the patient must have a documented contraindication, inadequate response or intolerance to Cortrophin Gel;
Thanks JT, they just keep on coming
Looks like Blue Cross Blue Shield Association, Highmark Inc. (the Health Plan) is requiring that Corti be tried first over Acthar except for Infantile Spasms.
For H.P. Acthar Gel requests excluding diagnosis of infantile spasms, member must use Purified Cortrophin Gel, unless contraindicated or clinically significant adverse effects are experienced
If History is any Indicator ...
Back on 5/20/19 the closing price was $68.47.
On 6/24/19 the closing price was 82.20.
That would be great IF that were repeated this time!
I wonder how long we wait for that $80?
Thanks auh2oman.
New Coverage ...
ANI Pharmaceuticals (NASDAQ:ANIP) Receives New Coverage from Analysts at Capital One Financial
https://www.marketbeat.com/instant-alerts/nasdaq-anip-initiated-coverage-2024-03-15/
Looks like AvMed is also indicating Corti as the preferred drug over Acthar.
AvMed Pharmacy Prior Authorization/Step-Edit Request
HP Acthar® Gel (repository corticotropin) *Member must have tried and failed preferred Purified Cortrophin™ Gel and meet all applicable PA criteria below
I think Pauly P. may have some shares, 🤣
I found it interesting that it also included trying Corti for Infantile Spasms before trying Acthar.
Great news JTFM! Glad to see our government being fiscally responsible (or maybe they are ANIP investors, who knows). What a great tailwind for the future.
I believe Medicaid is now indicating Cortrophin as the preferred over Acthar HP, at least it appears to be the case in some states such as those covered by Sentara Health Plans where Cortrophin must be tried before making a PA request to use Acthar HP.
Sentara
Silvr, it looks like most companies submit results within 30 days of receiving the pre-notice from the FDA.
Thanks for the update on Sangamo
That's an excellent source . You always earn your JTFM moniker.
For the technical geeks out there, Sangamo just announced a 10-100X improvement in the penetration of the blood-brain barrier in pre-clinical testing with non-human primates over the reference AAV9 (CERE-110) treatment. They are restructuring their company to now focus on neurology. I doubt our Ceregene intellectual property will still have any value here, but it is great to see progress against these nasty neurological diseases.
March Investor Presentation
I continue to admire the legacy of the Cell Genesys team that got all of this started.
Silvr, I check the trial site, as well.
I also check the list of FDA Pre-Notices for Potential Noncompliance.
There is obviously a reason for the delay that will make sense to us when it comes out.
If AbbVie is taking the lead, I wonder if the delay is timed to when Robert A. Michael takes over as CEO in July.
Easka, Nikhil is very conservative in estimating the potential market. He stated that he overall Acth sales in 2022 and 2023 were approx. $560 million. Which makes recapturing the prescription totals of 2017 a $1.12 billion market.
He is not talking about the potential peak market. I believe recapturing the prescription totals to 2017 levels still only covered between 30,000 and 35,000 prescription. This is less than 1% of the potential 4 million potential patients who are refractory to standard treatments which were identified when ANIP acquired Corti from Merck. I believe the holistic approach ANIP is is using in selling Corti will expand the market way beyond the 2017 numbers, especially when armed with the 1ml vial.
JMHO
Thank you JTFM. These results directly mimic what we have been speaking about for a long time now. I don't get the hold up given these are tangible benefits and there is a decade of safety data.
I regularly check the clinical trial site, but no change from the last update in October 2021.
Overall I think Nikhil was little nervous, maybe because he had a little audience.
From 10K Samy is authorized to sell up to 400000 more shares between 3/4/24 and 11/29/24. He sold more a couple of days ago.
I listened to Nikhil's presentation today the Leerink Partners Conference. Overall mainly a rehash from the earnings call, but did pick up few tidbits that I haven't heard or read. One interesting comment that I haven't heard before in the same context; "ACTH total patients in 2017 at the peak is Now down ~ 50% from that time". They do continue to grow the market since their Corti launch. Another tidbit, the 1ml vile of Cory for Gouty flare ups retails at almost $7000. per vile! How big is that potential market? Overall i think Nik
More supportive info for female testosterone.
According to Testosterone therapy in females is not associated with increased cardiovascular or breast cancer risk: a claims database analysis led by the School of Medicine at John Hopkins University.
Conclusions
We found a decreased risk of MACE among women with Testosterone Therapy as compared with matched controls and a similar risk of MACE in postmenopausal women while demonstrating a similar or significantly lower risk of breast cancer on age-based subanalysis.
Thanks auh2oman.
From Wall Street Zen ...
Impressive Q4 Results Propel Ani Pharmaceuticals to Record Growth
By Don Francis, Editor
March 6, 2024 3:05 AM EST
Guggenheim's Vamil Divan raised their price target on Ani Pharmaceuticals (NASDAQ: ANIP) by 10% from $70 to $77 on March 5, 2024. The analyst maintained their Strong Buy rating on the stock.
This price target hike comes in response to Ani Pharmaceuticals' impressive fourth quarter and full-year 2023 earnings report, which was released on February 29, 2024. The company once again achieved record quarterly results, with net revenues from cortrophin gel exceeding Guggenheim's forecast.
Ani Pharmaceuticals reported strong financial performance for the fourth quarter of 2023. The company's earnings per share (EPS) came in at $1.00, surpassing the Zacks Consensus Estimate of $0.80 and representing a 31.6% increase from the previous year's fourth quarter. Revenue for the quarter reached $131.65 million, beating the Zacks Consensus Estimate of $123.02 million and marking a substantial 39.8% growth compared to the same period in 2022. Adjusted EBITDA also showed significant improvement, rising 29.6% to $30.2 million.
For the full fiscal year 2023, Ani Pharmaceuticals delivered impressive results. EPS reached $4.71, a remarkable 246.3% increase from the previous year. Revenue for the year soared to $486.8 million, representing a 53.9% surge, while adjusted EBITDA rose to $133.8 million, a 139.4% jump. The company's management provided a fair and optimistic guidance for fiscal year 2024, anticipating an EPS range of $4.26 to $4.67. They also projected revenue growth of 7% to 11%, amounting to a range of $520 million to $542 million, as well as adjusted EBITDA in the range of $135 million to $145 million.
Nikhil Lalwani, President and CEO of Ani Pharmaceuticals, expressed his satisfaction with the company's performance, stating, "Q4 capped off a record year for Ani, as we delivered record growth in annual net revenue and adjusted EBITDA." Lalwani highlighted the strong performance of the company's lead Rare Disease asset, Cortrophin Gel, which experienced accelerated new patient starts in the fourth quarter. He also emphasized the momentum gained in net revenue, new cases initiated, and expansion into new therapeutic areas.
Looking ahead to 2024, Ani Pharmaceuticals plans to leverage its R&D capabilities, operational excellence, and U.S.-based manufacturing footprint to launch new products and address patient needs. The company expects its Rare Disease business, particularly the Cortrophin Gel franchise, to be the primary driver of growth, with an estimated over 50% year-over-year increase in revenues. Lalwani expressed confidence in the company's ability to drive market share in core therapeutic areas while also exploring new indications and expanding the overall ACTH market.
The analyst consensus among top-rated analysts is overwhelmingly positive, with 100% of them rating ANIP as a Strong Buy or Buy. No analysts recommend holding the stock, and none suggest selling it either. The analysts' consensus forecast for ANIP's upcoming year indicates earnings per share (EPS) of $1.65. If their predictions hold true, ANIP's next yearly EPS will see a substantial 91.8% increase compared to the previous year.
Since ANIP's latest quarterly report on February 29, 2024, the stock price has experienced a 3.4% decline. However, on a year-over-year basis, the stock has seen significant growth, with a 47.1% increase. During this period, ANIP has outperformed the S&P 500, which has risen by 25.4%.
Vamil Divan, the Guggenheim analyst who raised the price target on ANIP, is ranked among the top 5% of Wall Street analysts by WallStreetZen. Divan specializes in the Healthcare sector and has an average return of 16.3% and a win rate of 56.9%.
ANI Pharmaceuticals, Inc. is a biopharmaceutical company focused on developing, manufacturing, and marketing branded and generic prescription pharmaceuticals in the United States and Canada. The company's product portfolio includes controlled substances, oncology products, hormones and steroids, injectables, and other formulations. ANI Pharmaceuticals also provides contract development and manufacturing services for other companies. The company distributes its products through various channels such as retail pharmacy chains, wholesalers, distributors, mail order pharmacies, and group purchasing organizations. ANI Pharmaceuticals, founded in 2001, is headquartered in Baudette, Minnesota.
https://www.wallstreetzen.com/news/impressive-q4-results-propel-ani-pharmaceuticals-to-record-growth
I should know better. Share price is alway brought down after earnings. Should have sold some to re-buy later. It does not help that the CEO telegraphed that the quarter would be weaker albeit because of a known pattern in Cortrophin sales.
Thank you auh2oman.
They Keep Coming ...
ANI Pharmaceuticals price target raised to $77 from $70 at Guggenheim.
https://thefly.com/n.php?id=3876249
Another upgrade.
ANI Pharmaceuticals price target raised to $83 from $73 at H.C. Wainwright
H.C. Wainwright raised the firm's price target on ANI Pharmaceuticals to $83 from $73 and keeps a Buy rating on the shares following the Q4 beat. The firm says the company has momentum across its rare disease and generics units.
ANI Pharmaceuticals (ANIP) PT Raised to $80 at Truist Securities
Truist Rating
From the 10-k filing
We now know the royalty structure regarding Corti.
Our Cortrophin Gel product accounted for approximately 23% and 13% of our net revenues in 2023 and 2022, respectively. We pay to Merck Sharpe & Dohme B.V. ("Merck") quarterly contingent consideration in the form of a perpetual, tiered royalty expressed as a percentage of Cortrophin Gel net sales. During the initial two years of commercialization (2022 and 2023) this royalty approximated 10% of net sales. We currently anticipate the blended Merck royalty rate to be in the upper teens in 2024. In the case of significant revenue growth beyond 2024, we anticipate the blended rate may reach the low 20 percent range.
Looks like they stopped promoting it when Allergan (now AbbVie) was facing litigation in 2018, so Namzaric never reached peak sales projections
From AbbVie's 10-k filing
In 2018, a qui tam lawsuit, U.S. ex rel. Silbersher v. Allergan Inc., et al., was filed in the United States District Court for the Northern District of California against several Allergan entities and others, alleging that their conduct before the U.S. Patent Office resulted in false claims for payment being made to federal and state healthcare payors for Namenda XR and Namzaric. The plaintiff-relator sought damages and attorneys' fees under the federal False Claims Act and state law analogues. The federal government and state governments declined to intervene in the lawsuit. In March 2023, the court granted Allergan’s motion to dismiss, dismissing plaintiff-relator’s federal law claims with prejudice and state law claims without prejudice. The plaintiff-relator is appealing the court’s motion to dismiss ruling.
I believe ANIP acquired the drug form Amneal, who negotiated a deal with AbbVie to launch the generic Namzaric as early as January 1, 2025.
Launch
But the peak sales estimates are likely lower as it was affected by covid and AbbVie stopped promoting it.
Thanks JTFM. Spitball away. What an attractive buyout candidate now with $200M in the bank, a growing Cortrophin franchise, pipeline of material new drug launches, potential royalties in one of the hottest biotech companies right now, and lets not forget testosterone and all of the remaining hidden assets of the company.
I read yesterday that Kodak has a billion dollar surplus in their pension fund that they plan to tap into. Given their strategic shift to pharmaceuticals maybe they could be a suitor.
Great news JTFM. Makes you wonder why the company does not advertise these pipeline initiatives. This one looks like it will be very material.
Long- term here is another arrow in ANIP's quiver. On December 15,2023, ANIP received approval for the first generic version of AbbVie's Namzaric. Peak sale estimates are $574.1 million by 2025. AbbVie has a number of patents related to the drug with expirations ranging from 2025 to 2029. I don't know when the will be able to launch. But being first to launch with 6 months of generic exclusivity should add significantly to future revenues.
Approval
Peak sales
Prior to today, PPS had become somewhat stagnant, as trading volume had dried up. I imagine renewed interest is going to propel volume and PPS for the next couple of weeks, at least.
I though about Yescarta, as well. Hard to believe they can walk away from milestone payments and royalties.
CG Oncology obtained a patent for "Methods Of Treating Bladder Cancer By Combination Therapy Comprising The Oncolytic Adenovirus CG0070 And An Immune Checkpoint Inhibitor" which expires 2037-03-09,
https://patents.google.com/patent/US11497781B2/ja
Which I am certain ANIP could make a claim on some portion of prior art. This could delay any FDA approval, as the matter would likely need to be resolved before they receive a final approval. This could get them to abide by the initial agreement or force them to settle out.
It would also gum up any potential buyout. Unless of course, the buyout or partner to CG oncology is also partnering with ANIP on testosterone and makes it worth their while to step down.
Just spit-balling scenarios.
I saw the article today as well. He does a lot of best lists. I don't know how accurate his predictions are. But it is fun to consider.
Just for fun...
Stocks that Will Double in 2024 (See #10)
I agree JTFM, just like the Yescarta situation. Hopefully, our patent position here is not as convoluted as Yescarta's was. The good thing is that this asset is no longer hidden. Maybe we may even get a question from an analyst someday. Hard to miss having a royalty agreement with a $2B oncology company for their lead asset that is performing so well for the patients.
I was pleasantly surprised at the number of shares held and that we still had them.
Thanks auh2oman
Thanks Silvr, so they are disputing right for ANIP to receive royalties.
Where would they be without CG0070. Pure greed.
Congrats all.
Here is an update on CG Oncology from the 10K:
On November 15, 2010, ANI, formerly Biosante, entered into an assignment and technology transfer agreement and stock subscription agreement (collectively the "CG Agreement") with CG Oncology, Inc. formerly, Cold Genesys, Inc. (“CG Oncology”), pursuant to which the Company sold to CG Oncology exclusive, worldwide rights to develop and commercialize BioSante’s oncolytic virus technology. The technology includes a replication-competent adenovirus that has completed clinical trials for treatment of superficial bladder cancer. Under the terms of the CG Agreement, the Company received an equity investment in CG Oncology, an upfront cash payment and the right to receive future royalty payments. Historically, this equity investment was recorded at cost and as of December 31, 2023, this equity investment was valued at zero. On January 24, 2024, CG Oncology completed their Initial Public Offering, at an offering price of $19.00 per share. The Company currently holds 219,925 shares of common stock in CG Oncology. As of February 27, 2024 these shares are valued at approximately $10.2 million.
On February 28, 2024, CG Oncology disputed the Company's rights to receive royalties. The dispute is unresolved at this time.
The Other Day ...
Posted an article written by a Pharmacist, Michele B. Kaufman, for The Rheumatologist, regarding the approval of Indomethacin last month for patients who are unable to swallow solid dosage forms. Indomethacin is approved to treat patients with rheumatoid arthritis, ankylosing spondylitis, severe osteoarthritis, acute painful shoulder (tendinitis and/or bursitis) and acute gouty arthritis.
This can only create an awareness among professionals in the field of Rheumatology that there is an 180 day market exclusivity granted to ANI Pharmaceuticals for the generic NSAID and they very well could be writing scripts for Cortrophin for their patients already or this approval, more importantly, could get those sales people in the door to increase those Cortrophin 1 ml vial size for the adjunctive treatment for this condition as well as promoting their exclusivity with Indomethacin.
BTW, Great Numbers Today !
JTFM Another beat and Raise, great qtr and year. Agree, they will keep adding to full year guide as we move throughout the year. I still project ~ 575M for 2024.
R & D expenses increased in 23 to ~ 9M, i think he said and will grow more in 24 to support generics. Looking at multiple targets for M & A this year. I can't understand why he can't give more detail on the 1ml vile for gouty arthritis. He says he doesn't want to give out any competitive information, But They are the only
supplier approved for this indication! Doesn't make sense.
Good earning CC Lalwani went into greater detail into what is fueling Corti growth, indicating they see a long runway for growth. Still would not provide details regarding 1ml vial's impact on growth due to it being early in the launch.
Q1 Corti sales expected to dip over 2023 Q4, as coverage for 2024 is established. Then continued quarter over quarter growth continues. This Q1 dip appears common in the rare disease business.
Just like last year, increased guidance, as the year progresses.
ANI Pharmaceuticals Inc (ANIP) Reports Strong Growth in Q4 and Full-Year 2023, Sets Positive ...
https://finance.yahoo.com/news/ani-pharmaceuticals-inc-anip-reports-121156111.html
FDA Update: Approval for Generic NSAID ...
Michele B. Kaufman, PharmD, BCGP | February 27, 2024
New Generic NSAID
The U.S. Food & Drug Administration (FDA) approved an abbreviated new drug application for indomethacin oral suspension. This non-steroidal anti-inflammatory drug (NSAID) is a generic version of Indocin Oral Suspension.1
Indomethacin is approved to treat patients with rheumatoid arthritis, ankylosing spondylitis, severe osteoarthritis, acute painful shoulder (tendinitis and/or bursitis) and acute gouty arthritis. This suspension is advantageous for patients who are unable to swallow solid dosage forms.2
The current annual U.S. market for indomethacin oral suspension is approximately $4.1 million. This approval grants ANI Pharmaceuticals Inc. 180 days of market exclusivity.1
https://www.the-rheumatologist.org/article/fda-update-approval-for-generic-nsaid-new-boxed-warning-for-denosumab/
Medspray angle for Libigel would be very interesting. Walsh is well positioned to guide a partnership.
Thanks Dasgrunt.
Congrats on sticking with NVDA. I agree on the acquisitions potential or at least some strategic partnerships.
Interesting development dasgrunt. Medpharm has the MedSpray technology. I believe it was used in Axiron which is now discontinued. I recall JTFM mentioning it once before. Maybe there is a Libigel angle here although Medpharm is not a production manufacturing company.
Another possibility is that we will see more 505B introductions by ANIP behind the MedSpray delivery technology.
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