ANI Pharmaceuticals (ANIP)

[Just the facts maam]

United Healthcare Pharmacy's Step Therapy Program differentiates FDA approved indications between Acthar and Corti.

If Acthar generated approx. $1.2 billion in sales while only FDA approved for the indication of Infantile Spasms and Multipole Sclerosis and are only suggested for other indications. How much larger can the market grow when Corti's FDA approved indications are added:

• Rheumatic disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: Psoriatic arthritis. Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance
therapy). Ankylosing spondylitis. Acute gouty arthritis.
• Collagen diseases: During an exacerbation or as maintenance therapy in selected cases of: Systemic lupus erythematosus. Systemic dermatomyositis (polymyositis).
• Dermatologic diseases: Severe erythema multiforme (Stevens-Johnson syndrome). Severe psoriasis. Allergic states: Atopic dermatitis. Serum sickness.
• Ophthalmic diseases: Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: Allergic conjunctivitis. Keratitis. Iritis and iridocyclitis. Diffuse posterior uveitis and choroiditis. Optic neuritis. Chorioretinitis. Anterior segment inflammation.
• Respiratory diseases: Symptomatic sarcoidosis.
• Edematous states: To induce a diuresis or a remission of proteinuria in the nephrotic syndrome without uremia of the idiopathic type or that due to lupus erythematosus.
• Nervous system: Acute exacerbations of multiple sclerosis.

Corti/Acthar Step Therapy

We know that Acute Gouty Flares is one revenue stream not included in Acthar's previous sales. Arguably even if Acute Gouty Arthritis flares affects 1% of the 9 million patients affected by Gout you are looking at an addressable market of $630 million, just for this indication. How of this market they capture remains to be seen.

It would be nice if Lalwani would frame the long term market addressable markets for Corti by indication, rather than have analyst believe that Acthar peak sales is the ceiling.

JMHO

[Just the facts maam]

Centene Covers 27.5 million managed care members across 50 states. They require a trial of Corti before trying Acthar for the following:
Multiple Sclerosis and Nephrotic Syndrome.

Acthar is give priority for Infantile spasms.

The following coverage does not provide a preference between Corti or Acthar: Rheumatic Disorders, Collagen, Dermatologic, Ophthalmic, Respiratory Diseases, Allergic States

This assumes Centene's subsidiaries are consistent with their subsidiary PA Health and Wellness.

Centene

[silvr_surfr]

Thanks JTFM for tracking this. A bullish development to be sure. It seems like the smaller plans are definitely favoring our product because of the price differential.

[Just the facts maam]

PacificSource Community Solutions also gives preference to Corti over Acthar except for Infantile Spasm.

Acthar HP requires a documented intolerable adverse event to a trial of Purified Cortrophin Gel

PacifcSource

[Just the facts maam]

Easka, regarding Corti gout, the have no competition from Acthar with over 9 million patient affected by Gout and Corti 1ml selling for approx. $7,000 . If one only 0.5 % of this patient population is captured you are looking $315 million in revenue. Being able to be administered in the physician office, I think you will see uptake where standard of case is not working. We should see the proceeds from the Oakville plant in Q1 earnings. We may also see Sammy and Company get some earn out money.

I see guidance being raised in each quarter, even without acquiring a rare disease asset.
.

[Easka]

JTFM, Yes I know he was not talking about "potential" peak market for Corti, he was comparing it to past peak patient counts in 2017. I agree you, with all the work they are doing to educate and re-educate the payers, doctors and patients about ACTH, hopefully they can blow past that 2017 peak, in a few years.

Nikhil should be a golfer he is such a sandbagger! The 24 guidance numbers just seemed way to low to me. I had to re-read the EC transcript. He is calling for 520-542M in revenue for 2024, with Corti Rev of 170-180M (not including any new indications ie gouty arthritis), Generics revenue to grow high single to low double digits growth.

In 2023 their Rev was 486.8M, Corti Rev. 112M, Generics 269.4M, Branded products, royalties and other Rev. 105.3M. Using Nikhil's Conservative guidance,
Corti will be up 58M to 68M, Generics should be up 24.2M--32.3M using 9% low and 12% high side of guidance. They didn't give guidance on Branded products and royalties, assume this stays the same at 105.3M YoY. If that's the case, that brings us to 569-587M for 2024 revenue, that also doesn't include any new generics or new Corti indications. So unless the Branded drug and Royalties and other has a major crash this year, we should see a least a couple more Beat and Raise ER's coming this year! Btw how is the sale of the Oakville plant, I think 13M USD in Q1, accounted for?

[Just the facts maam]

The BlueCross / BlueShield Federal Employee Program indicates Corti as preferred over Acthar except in Infantile Spasms

Patient MUST have tried the preferred product (Cortrophin Gel) unless the patient has a valid medical exception (e.g., inadequate treatment response, intolerance, contraindication)

Federal Employee Coverage

[Just the facts maam]

AmeriHealth Caritas District of Columbia is another plan that lists Corti as prefered over Acthar.

Corti coverage

[Just the facts maam]

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;

Medicaid Coverage

[big bambino]

Thanks JT, they just keep on coming

[Just the facts maam]

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

Highmark coverage

[auh2oman]

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!

[north40000]

I wonder how long we wait for that $80?

[Just the facts maam]

Thanks auh2oman.

[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/

[Just the facts maam]

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

About AvMed

[big bambino]

I think Pauly P. may have some shares, 🤣

[Just the facts maam]

I found it interesting that it also included trying Corti for Infantile Spasms before trying Acthar.

[silvr_surfr]

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.

[Just the facts maam]

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

[Just the facts maam]

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

[silvr_surfr]

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.

[Just the facts maam]

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.

[Just the facts maam]

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

[silvr_surfr]

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.

[Easka]

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.

[Easka]

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

[Just the facts maam]

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.

[Just the facts maam]

Thanks auh2oman.

[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

[silvr_surfr]

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.

[silvr_surfr]

Thank you auh2oman.

[auh2oman]

They Keep Coming ...

ANI Pharmaceuticals price target raised to $77 from $70 at Guggenheim.

https://thefly.com/n.php?id=3876249

[Easka]

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.

[Just the facts maam]

ANI Pharmaceuticals (ANIP) PT Raised to $80 at Truist Securities

Truist Rating

[Just the facts maam]

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.

Based on guidance should account for approx. 33% of revenue for 2024.

[Just the facts maam]

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.

[Just the facts maam]

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.

[silvr_surfr]

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.

[silvr_surfr]

Great news JTFM. Makes you wonder why the company does not advertise these pipeline initiatives. This one looks like it will be very material.

[Just the facts maam]

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

[Just the facts maam]

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.

[Just the facts maam]

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.

[Just the facts maam]

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.

[silvr_surfr]

Just for fun...

Stocks that Will Double in 2024 (See #10)

[silvr_surfr]

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.

[Just the facts maam]

Thanks auh2oman

[Just the facts maam]

Thanks Silvr, so they are disputing right for ANIP to receive royalties.

Where would they be without CG0070. Pure greed.

[silvr_surfr]

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.

[auh2oman]

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 !