ANI Pharmaceuticals Inc (ANIP)

Bagel, if Merck is looking at buyout ANIP, it could happen by the end of year or early January going into the JP Morgan Healthcare Conference.

Google AI's response to "when is the best time to acquire another profitable biopharmaceutical company when you are facing a patent cliff?" The response was
The ideal time to acquire a profitable biopharma company is 36 to 24 months before your own Loss of Exclusivity (LOE). Acting during this window allows you to de-risk late-stage assets and secure shareholder buy-in before your revenue drops, preventing a sudden valuation hit

Merck is facing loss of exclusion for:

Keytruda- December 2028 (US), 2031 (EU), 2028 (China) and (2032-2033)
Rrevenue of $18.83 Billion (US) $12.81 billion (Intl) in 2025

Gardasil- 2028 (US), 2030 (Japan and EU).
Revenue $2.64 billion (US) $2.59 Billion (Intl).

Coincidentally, the M.D. Anderson Cancer Center is expected to release the results of a 700,000 participant retrospective study titled "Evaluation of Association Between Testosterone Levels, Dementia, and Adverse Mental Health Outcomes", with an estimated completion date of November 30, 2028. The last enrolled patient will have completed their participation by February 17, 2028, if not sooner.

The timing is nice for Merck to announce testosterone related trials upon the results of the MD Anderson study becoming public.

FYI, In 2015, Merck entered into a collaborative research agreement for Keytruda. I can see a similar agreement for large Libigel Alzheimer's related trials.

Ok, so it's a bone, but the HHS just implemented label changes for men's testosterone to "follow the science". Here's what was said in the article:

“As our understanding of testosterone therapy continues to evolve, prescribing information should reflect the best available science,” said Brian J. Christine, M.D., Assistant Secretary for Health. “This action helps ensure patients and healthcare providers have accurate, up-to-date information when considering treatment options.”

One would have to think women are a part of understanding it.

HHS Action

Just checked the FDA Complete Response Database, no indication that ANIP received a CRL for their outstanding Q3 2023 NDA (most likely Libigel). It should still be in play.

Bagel, I agree with Silvr, ANIP may get tire kickers, but likely won't support a buyout until Libigel approval has been realized. Even so, ANIP will probably wait until Libigel related patents have been secured, in order to maximize shareholder value. Unless the suitor is willing to take the risk on securing the patents.

I am still looking at the data but among US pharma/biotechs it looks like only LLY, REGN, UTHR, BIIB and AMGN had higher gross profits on a per share basis, than ANIP who had $27.57 in gross profits per share (TTM) and is guiding towards $31.18 for 2026.

FYI, Merck is still looking for deals and have set a range of $1 to $15 billion for deals. A Libigel approval could eventually warrant a $15 billion offer, or a lower offer and CVRs related to the CV and Breast cancer patents. Just spit-balling here.

ANIP's increasing the registered shares to 66 million prepares them for long term growth, in the event future offers are not supported by shareholders.

If the goal is to be a leader in rare disease look for ANIP to acquire a company with a recently approved drug or pending PDUFA with a high degree of certainty in its approval. This will give ANIP a clinical research team to tackle novel drugs. Such a move would signal that ANIP does not intend to be sold for a while. Working on revenue growth beyond 2043. This could be when ANIP starts posting a pipeline and PPS reflects its true value.

JMHO

A thought of any pending deal was always connected to FDA approval of Libigel which of course has not happened. A rigorous FDA review is warranted, but the market is demanding it. I saw a recent article where usage has skyrocketed of late.

just curious, did the thought of ANI being bought out dry up?

Yes, quite disappointing. How do you underfill product with today's technology.

Read of a recall for estradiol gel. Hope this is not an indicator of poor quality control in Anip .

Could be, Silvr.

There was a healthy discussion at yesterday's investor call about the validity of IQVIA data. This is the data that that is used to track prescription volume and other analytics. I guess IQVIA was showing a decline in Cortrophin volume. The consensus from Nikhil and even the host was that the data are not reliable. Nikhil reiterated continued momentum growth without giving a specific intra-quarter forecast,

Today we get a reversal. behind over 0.5M shares. I wonder if the shorts believed the data.

Bagel, according to the following Google AI overview, I think ANIP is slowly working towards getting PPS moving. Much of PPS price suppression appears tied to the convertible notes and ANIP appears to be working on 3 of the 5 listed strategies to raise PPS. Personally I would like to see ANIP announce the intent accelerate the repurchase of shares, in addition to repurchase the convertible notes early in the secondary market, and retire the notes. It would send a clear signal to hedges to start covering short positions or risk a short squeeze.

Hopefully ANIP is using the current low PPS to accelerate share repurchasing.

The following is from a Google AI overview, which likely explains what we are seeing.

Convertible arbitrage on ANI Pharmaceuticals (NASDAQ: ANIP) causes price suppression because buyers of the company's convertible senior notes routinely short-sell the underlying common stock to hedge their positions. This continuous algorithmic selling creates downward pressure on the stock price, keeping it range-bound.

When ANI Pharmaceuticals issues convertible debt, institutional investors utilize a delta-neutral hedging strategy. Here is how it unfolds:

- The Short Hedge: Buyers of the convertible notes borrow and sell ANIP common stock short. This allows them to lock in a risk-free profit on the interest rate while neutralizing the stock's price movements.

- Downward Pressure: Because the hedge is tied to a large block of convertible notes, the volume of short-selling can be immense. This selling pressure artificially suppresses the share price, preventing it from reflecting the company’s underlying fundamentals.

- Short Squeezes: If the stock breaks out, the arbitrageurs must "cover" (buy back) their short positions to maintain their delta-neutral hedge, which often results in rapid, volatile upward price spikes.

- Capped Calls: To mitigate this dilutive impact, ANI sometimes negotiates capped call transactions. These increase the effective conversion price and protect existing shareholders from extreme dilution, but the initial shorting mechanics generally still suppress short-term rallies.


I further asked what can ANIP do to increase PPS and received the following result.

To counteract the short-selling pressure from convertible arbitrage and drive up its price per share (PPS), ANI Pharmaceuticals (NASDAQ: ANIP) must implement corporate actions that either consume the available short float or deliver growth that outpaces the arbitrageurs' algorithms.

As of mid-2026, the company has already begun deploying some of these strategies to force a fundamental revaluation.

1. Accelerate the $100 Million Share Repurchase Program - In May 2026, ANI authorized a new $100 million share repurchase program. To aggressively drive up the PPS, management can maximize the tactical execution of this program:
- Absorb the Arbitrage Selling: Executing open-market buybacks actively absorbs the artificial supply of shares being shorted by convertible noteholders.
- Reduce the Float: Shrinking the outstanding share count naturally expands earnings per share (EPS), forcing a higher valuation.
- Trigger Short Covering: Consistent corporate buying can push the stock price upward, forcing arbitrageurs to actively buy back shares (cover) to adjust their delta-neutral hedges.

2. Sustain High-Margin Growth in the Rare Disease Segment
Convertible arbitrageurs base their short positions on statistical modeling (delta). When a company delivers structural, explosive earnings growth, the model breaks down, forcing short covering.
- Leverage Cortrophin Gel: ANI's Purified Cortrophin® Gel and specialty products are projected to account for 60% of total 2026 revenues.
- Capture the Gout Market: Fully executing its massive 2026 salesforce expansion to target 7,000 new healthcare providers for acute gouty arthritis flares will fuel the high-margin revenue needed to outrun the short interest.

3. Retire or Refinance the 2029 Convertible Notes Early
The root cause of the current structural price suppression is the $316.25 million in 2.25% convertible senior notes due in 2029. To eliminate the arbitrage entirely, ANI can utilize its strong cash flow to systematically dismantle the debt structure:
- Opportune Deleveraging: ANI generated $185.2 million in operating cash flow in 2025 and held a robust cash balance through early 2026. Management can deploy excess cash to buy back portions of these convertible notes early in the secondary market.
- Remove the Hedge Requirement: Once a block of notes is retired, the institutional holders are legally required to unwind and close out their corresponding short positions, sparking a massive buying wave.

4. Optimize the Capped Call Restructuring
During the initial debt offering, ANI spent $40.6 million on capped call transactions to hedge against dilution. If the stock begins a sustained upward trend, management can effectively communicate the protective boundaries of these capped calls to institutional investors, mitigating the market's fear of dilution and attracting traditional "long-only" growth funds.

5. Expand Accretive M&A Activity

ANI has a proven history of utilizing its cash and generics business to fund high-growth acquisitions (such as Alimera Sciences). By executing highly accretive, immediately profitable acquisitions in the rare disease space, ANI can rapidly scale its non-GAAP EBITDA guidance (which was already raised to $285M–$300M for 2026), making the stock too cheap on a P/E basis for the market to ignore

When you routinely get sales near or at the bid, it seems like this is what the shorts do.

I agree bagel123. With the shorts still hanging around, I think they are the most likely culprits. The analysts have price targets over $100.

Maybe the shorts are counting on Nikhil flubbing today's investor call like last time. The only other thought is retail and institutions selling ahead of the Spacex IPO to chase a better return.

GLTA

I agree bagel123. With the shorts still hanging around, I think they are the most likely culprits. The analysts have price targets over $100.

Maybe the shorts are counting on Nikhil flubbing today's investor call like last time. The only other thought is retail and institutions selling ahead of the Spacex IPO to chase a better return.

GLTA

What the hell is going on with this POS stock price??? I wish i sold more in the 90s like i said i would. it's ridiculous.

The Libigel trademark received a Notice of Allowance from the USPTO on 12/23/25. They have six months from this date to either file.a Statement of Use or file an extension. I'm skeptical they will put it into use this month so we should see an extension.

Nope. Shorts are still holding strong at 3.6M shares as of the 5/15 settlement date. I don't get their investment thesis in the face of higher guidance, a whole new royalty revenue stream and gouty flare action in the second half. I hope Libigel does them in. What a day that would be.

Ooops, you're right. My search is date bound so don't know why it picked this up. Bad eyes too. Sorry for the confusion.

Ooops, you're right. My search is date bound so don't know why it picked this up. Bad eyes too. Sorry for the confusion.

Let me try again. It says it was an April 2026 podcast.

Let me try again. It says it was an April 2026 podcast.

Hi Silver, your link brings us to a comment from 2008. Is this what you’re referring to ?

Here's a recent podcast from Dr. Casperson. It is a long one, but contains lots of info. Here are the things that caught my attention:

Dr. Casperson Podcast

1) Opthamologists are using testosterone drops to treat dry eye off label (Iluvien?)
2) There is a separate study done that shows a 30% reduction in breast cancer incidence for women using testosterone.
3) She was asked if money were not a constraint what study would she do and she said a placebo controlled study for dementia- she believes the benefit is there.
4) As many women are using testosterone as men.
5) Many mature drugs were approved with six months of safety data with a male population only - why can't the male testosterone studies then apply.
6) Menopause is not a defining moment when a woman's testosterone decreases. It is gradual from the 20's. However, post menopause has been a criteria for testosterone use in women probably from a fear of use among child-bearing women.

This is by no means proof, but here's a subject matter expert recently saying Libigel is "under FDA review".

Hystersisters Response

ANIP and one of my other stocks were down today and pinned. I did not get it until I looked at the option chain. Sure enough market makers want to keep our price below 80 for tomorrow's close.

Thank you JTFM. This is a simpler test than the conventional LC/MS. This should be a catalyst for broad adoption of clinical prescribing of Libigel.

Thanks for the correction.

Looking quickly at the new Vanguard entities reporting holdings in ANIP (I counted 6 new ones), their sum total is 1.350MM shares held as of 3/31/26, vs what Vanguard reported at 12/31/25: 1.305MM shares. A net increase of about 45k shares during Q1

No, that's not accurate. Vanguard went through a recent restructuring of their institutional management and they now report holdings under a number of different entities. They used to report under one company:
https://13finsight.com/learn/vanguard-reporting-entity-reshuffle-13g-2026-explained

FDA approves an easier method for testosterone testing for both men and women. Results available within 45 minutes.

https://www.urologytimes.com/view/fda-grants-clearance-to-total-testosterone-assay

Insiders all selling. When this occurred in August and September 2025, it led to PPS climbing to $99.50.

Thanks North., I agree with Silvr, hopefully it does not negatively affect Libigel

Roddy, Vangard Capital Management picked up 863,064 shares. According to Nasdaq, institutions now own 22,776,644 shares. Institutional ownership now sits at 100.18%. Short interest sits at 3,562,734 shares.

When I see large selling of ANIP. I have seen large note purchase of a similar size. Look for Global’s future filings to see if the aquited any convertible notes.

According to a Securities and Exchange Commission (SEC) filing dated May 11, 2026, Global Alpha Capital Management Ltd. sold 228,895 shares of Ani Pharmaceuticals (NASDAQ:ANIP) in the first quarter. The estimated transaction value was $17.87 million, calculated using the period's average closing price. The position's quarter-end value decreased by $18.81 million, a figure that incorporates both trading activity and price changes.

Thanks North. I thought he would be an asset for a Libigel approval given his history and statements. Hopefully, the approval is well enough along that is will not be impacted. The interim person comes from the food area.

Thanks North. I thought he would be an asset for a Libigel approval given his history and statements. Hopefully, the approval is well enough along that is will not be impacted. The interim person comes from the food area.

CNBC-TV: Makary resigns from FDA.

50,600 SHARES TRADED @ $77.03 AT 4:14

Best case scenario - the non-convertible bond shorts exited the past two days behind the 2.1M shares traded. Maybe we get a reversal beginning tomorrow.

Abh3vt, the two stage milestones in Q2 and Q3 is consistent with Harmony's assertion of filing NDA for PITOLISANT GR in Q2, the second milestone is likely the FDA acceptance of the application. The $10 million is likely a Q3 event, revenue for that quarter will also be supported the results of the Acute Gouty Arthritis team.

Regarding potential royalty streams:

The CEO has never articulated this facet of royalty revenue. But Samy Shanmugam, the founder of Novitium (Now ANIP) and Nuray Chemicals, is ANIP's Director and Head of R&D and COO of NJ Operation

The IP from the Harmony deal was acquired from Nuray Chemicals and extends to 2042.

https://patents.google.com/patent/US11945788B2/en?q=(chemicals)&assignee=nuray&oq=nuray+chemicals

I can envision a similar, yet more lucrative deal with Pfizer. Nuray Chemicals also IP regarding an improved version tafamidis (Pfizer's Vyndaquel/ Vyndamax) patent extending to 2041. Incidentally, Matthew Leonard, who sits on ANIP's BOD, joined Pfizer, Inc. in December 2023, as Senior Vice President, Global Access and Value.

https://patents.google.com/patent/US11523993B1/en?q=(chemicals)&assignee=nuray&oq=nuray+chemicals.

ANIP is also still litigating royalty rights from CG Oncology, which I can see this heading to SCOTUS to address the inequities regarding patent erosion while drugs are working their through trial and the approval process.

Finally, there is Libigel. I expect some form of partnership. It will be interesting to see if ANIP is looking at copromotion/co-development deal, or just looking royalties and milestone payments.

Personally, I believe more positive news is coming before the 2027 guidance is provided. But 2027 guidance will still prove important.

I had to re-read this quarter's PR and CC transcript a few times to try to make sense of the royalties/milestone payment confusion. The company didn't really help with the wording in the PR and in the Q.

"Under the Harmony Agreement, the Company received an upfront license fee of $15.0 million and will receive $10.0 million upon achievement of certain development milestones, which is expected to be achieved in the second and third quarters of 2026."

The CEO said what I think is critical, that this is ONE milestone payment of $10MM that will be triggered by the achievement of milestones that take place and should be achieved in Q2 and Q3. Note he specifically said "across" both quarters:

"....that $10 million will be achieved across the second and third quarter of this year."

I originally thought the 10MM can be earned in each quarter, but I think its a two stage milestone that once reached triggers a one time payment of $10MM. I think the $15MM was part of the original guidance, since they knew about that back in January. The remaining milestone of $10MM plus other "refinements" to the royalty revenue outlook were added to the new guide. So, if we wanted to look at the quarter (Q1) without the license fee of $15MM, I would estimate that this fee added roughly $11.1MM or 0.52/share. Even if you back that out, they still beat the analysts' estimates for the quarter of 1.30. I think the analysts were probably also surprised by the license fee too, as they clearly had not factored that into the quarter. Did the CEO or the company ever mention this facet of revenue before?

Regarding the guidance raise, the full 10MM+ of "unexpected" revenue that may be one-time in nature adds roughly 0.35 of the increase. (Again, I'm assuming that the license fee of $15MM was known to the company back in January when they first issued guidance for FY26 revenue and eps.) The midpoint of the guide for revenue went up slightly, by $25MM. Probably half of that increase came from the milestone revenue and other royalties. The eps guide went from 9.09/sh up to 9.44/sh, so they basically didn't increase earnings estimates outside of the milestone revenue and earnings from that source.

The real key is to keep an eye on FY27 numbers. I'm assuming that we'll still see decent strength in revenue and earnings; the hard part is trying to nail down what is an appropriate LT valuation for this company. A lot of these specialty pharmas don't really get a high forward PE because of the concerns surrounding patent expirations and increased competition in the future.

Welcome to ANIP, who always seem to cloud the waters.

- Inzirqo and Tezruly approved no announcement though Tezruly has been discontinued for now. They announce CGT generic approvals with $3.1 million in sales but not an NDA with patent protection to 2040's. Looks like they are still working through the Insurance coverage.

https://inzirqo.com/

They filed another NDA in Q3 2023 where there is no record of ANIP paying the NDA submission fee to the FDA. (Another undisclosed partnership in the wings)

They revived the Libigel trademark in May 2025. And was issued a Certification to delay submitting study results to the 3,656 participant Libgel trial. Certifications are issued in relation to NDA filings.

Request for updates on these products have fallen flat to date. Hopefully things will change soon.

ANIP

I've read that 4 times and now admittingly I'm confused what was included and what wasn't in original guidance because there comments of refinement make me wonder since they said originally they didn't know when the 10 million milestones were gonna hit, maybe the upfront payments were included in original guidance and the milestone weren't. to me after reading it 4 times I have more questions than answers in my opinion. All is just my opinion, and I could always be wrong though.

According to the earning conference call in responding to Vival Divan, ANIP stated that the guidance ANIP issued in January included the Harmony deal.

So our initial guidance, which we issued in January, included Cortrophin at $540 million to $575 million, ILUVIEN at $78 million to $83 million, revenues from the out-licensing agreement, gross margin at 59.3% to 60.3%, and adjusted EBITDA at $275 million to $290 million. Our newly raised '26 guidance retains Cortrophin and ILUVIEN revenue guidance. And so for the guidance increase, it's really driven by high Generics revenues on the back of first quarter and visibility into new product launches for the rest of the year. That's one.

Second is clarity around the milestone achievement of the $10 million, the development milestones that is there in the Harmony agreement. So we have more clarity around when that can be achieved. And I think Steve had spoken that, that will be achieved in the second and third quarter, that $10 million will be achieved across the second and third quarter of this year. And third is just refinement of the royalty revenues expected for this year based on the updated 2026 guidance issued by Harmony.

When considering EPS growth concerns, it looks like ANIP has accelerated its hirings beyond those in the acute gouty arthritis team. Both in the US and Europe.

Personally, I am looking forward to market reaction to Libigel when announced. Hopefully soon.

ANIP

I don't own ANIP at this point, but have owned it before, and for disclosures purposes I would think about buying it back in the low to mid 70's if it ever got there. But I wasn't surprised that it didn't go up in fact looking at the quarter I thought it would trade into the 70's short-term.

Keep In mind the midpoint was raised about .35 this year. Having said that this upfront payment and milestone payments are one time or at least episodic in nature. Hence I would ex this out. I don't believe they were in guidance before, hence they actually lowered guidance on the rest of the year, hence why the stock is down. I mean based on my math 35 million, taxing that at say 25%, they have lowered the mid point for the year if you ex this episodic revenue and earnings by .87. Now do I believe they are being conservative and they see it as a way to continue to raise guidance in future quarters, most likely that is the case. having said that based on the math, I understand why the stock sold off a little, because although it looks like they raised guidance in the short-term in reality if you don't like to add in this episodic revs and earnings which appear to have not been built into guidance originally, at least that is my take, they really lower the bar almost by 10% this year which isn't great in my opinion. Now I do believe that probably this company is being conservative, and I do believe the future is bright here, so there is that as well. Having said that I can't say this quarter's guide was a positive it was a slight negative in my opinion. All is just my opinion and I could always be wrong though.

Silvr, institutional holdings reached 100.31 % with many institutions having yet to report. I expect this number to climb along with short interest. It is the only way they have been able to keep PPS suppressed.

https://www.nasdaq.com/market-activity/stocks/anip/institutional-holdings

I find the following response by Stephen Carey at the earnings CC very interesting.

To be clear, our principal goal for the excess cash on our balance sheet remains to support future business development and M&A. And within that framework, the addition of the buyback program really just gives us another tool in our tool belt as we actively manage the capital allocation plans going forward.Our shareholders should expect us to judiciously allocate cash between investment behind the strategic growth and diversification of the business, delevering our balance sheet and return of any excess capital to shareholders.

It is possible that ANIP intends to buy back the $100 million shares to eventually cover the shareholder's option to directly reinvest future dividends. This would be awesome.

If this is the case, I hope they keep paying the low interest the notes offer, which will allow for higher dividends.

At least one analyst now has ANIP EPS for 2030 at $21.60.

Regarding earnings call. Lalwani reiterated that most of the growth in Corti for 2026 is from the legacy indications, RA, Pulmonary, etc... There will be increasing Acute Gouty Arthritis sales which will have a full years affect in 2027. Though he previously stated this accelerated growth would extend to 2028. With 7,000 new prescribers being targeted in the US , it will take time to reach full penetration.

I believe the hedge funds are actively depressing PPS. That is why institutional investment is near 100% of the float and short interest is above 15%.

FYI, ANIP maintained Corti guidance of $265 - $274 million in Q1 earnings release for 2025, then went on to report $348 million in revenue. ANIP's MO, under Lalwani, has been to under promise and over deliver. I fully expect a raise in Corti guidance at Q2 earnings release and another raise in guidance at Q3 earnings release.

If analyst do the math they will come to the conclusion that Cori sales will be approaching $200 million in Q4. Using this as the 2027 run rate puts at $800 million for 2027. Though sequential quarter over quarter increase in market penetration should drive sales even higher in 2027 with continued growth going in 2028.

I would also not be surprised if they eventually intend to get Corti approved in Europe, why else would they have presented findings for the use of Purified Cortrophin® Gel in Murine Collagen-Induced Arthritis Mouse Model at the European Alliance of Associations for Rheumatology (EULAR) 2025 Congress in June 2025.

https://investor.anipharmaceuticals.com/news-releases/news-release-details/ani-pharmaceuticals-announces-presentation-new-preclinical-data

The trading in ANIP the day of earnings was wild. It opened at 87.76 and then proceeded to drop like a stone, hitting the low of the day (79.37) 15 minutes later. Volume was heavy, as you would expect around the release of earnings. A couple of big block trades at the close kept the stock out of positive territory on the day and at a price that is just below the technically important 200 day MA.

I listened to the call, and the transcript is here:
https://seekingalpha.com/article/4901415-ani-pharmaceuticals-inc-anip-q1-2026-earnings-call-transcript

There was definitely some confusion about the quality of the earnings "beat and raise", as they had additional license fee revenue of 15MM in Q1 and also guided for other development milestones being hit in both Q2 and Q3 that trigger payments of $10MM in each quarter. Analysts questioned how much of that was already in the company's previous guidance, so I guess questioning the actual strength of the underlying business going forward? As we all know, this company always guides conservatively, so that it can keep the bar low and be able to continue raising guidance in most quarters. I was surprised that the stock closed lower on the day, given the increased guidance and analysts now increasing their eps estimates for next year as well. I guess whenever guidance is back-end loaded, there is always a little bit of concern as to whether the company can achieve its goals.

JTFM, what is your take on the earnings call and trading reaction?