Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Given all the secrecy surrounding the NDA's including ANIP having a partner most likely for a pending female testosterone approval combined with the fact that AbbVie has yet to announce that they are presenting at the Morgan Stanley Healthcare conference which starts tomorrow, it makes me believe some type of major announcement is coming this week. Hypothetically, if Merck and AbbVie are combining to launch female testosterone, a deal could be announced on Thursday with AbbVie joining Merck at their 2:35 pm presentation.
Thanks North.
Thanks Brusselsspirit. Silvr, though ANIP or their partner are willing to take the Supreme Court, I don't think CGON will gamble losing the IND and data needed to make an NDA filing. It is too big a gamble for 5% of global sales. Though it is the perfect case to settle the matter as it relates to the pharma industry's lengthy drug approval process.
JMHO
Alimera votes on the ANIP acquisition September 4th. Merck presents at Morgan Stanley Annual Global Healthcare Conference on September 5th. No news from AbbVie, yet. Though they have attended every one of their conferences since they spun off from Abbott Labs. They also usually give more notice when presenting. If there is deal, I wonder if they are waiting on the FDA decision, which must be getting close.
Thanks for the update. I see they subpoenaed Kissae America. CG Oncology gave them exclusive commercial and developing rights for Japan and Asia (excluding China).
Thanks Silvr, every little bit helps.
With ANIP anything is possible. If CG Oncology is deemed to have breached their agreement, they may have royally screwed their investors.
Heavily manipulated 85,412 shares trade at 1:21 pm and the stock only goes up 28 cents. Something is definitely up.
Someone picked up at least 58,530 shares after hours. Makes me wonder if buyout or NDA decision is leaking out.
Yes, the volume both during regular trading and after hours is up significantly.
I see the short interest is up almost 1.36 million shares. No doubt they are all covered by convertible shares.
As for the two ID numbers, it could be ANIP acting on behalf of another entity.
On a side note, I reviewed the last quarter's earnings transcripts for both AbbVie and Merck, as it relates to business development and M&A . AbbVie indicated that they were good with near term growth for this decade and future deals would focus on growth for the next decade. Whereas Merck is committed to aggressively seeking business development deal in the $1 billion to $15 billion range. Either AbbVie is playing poker and keeping their cards close to their chest or an ANIP's buyout offer would likely come from Merck.
Hard to see AbbVie walk away from female testosterone. Personally, I was hoping ANIP acquired the Intrinsa portfolio and reviewed the Libigel data themselves. However, the breast cancer reduction discovery, in 2015, shoots down that possibility.
September should be exciting for ANIP.
Everyone, enjoy the holiday weekend and buckle up for the ride.
If a buyout is around the corner, next week would the perfect time to announce it. They could hit the three following conferences:
Sep 04, 2024 - Sep 06, 2024 Boston, MA - Wells Fargo Healthcare Conference
Sep 04, 2024 - Sep 05, 2024 Boston, MA - Citi 19th Annual BioPharma Conference
Sep 04, 2024 - Sep 06, 2024 New York, NY - Morgan Stanley 22nd Annual Global Healthcare Conference
When comparing ANIP and Alimera's combined revenue estimates for 2024 to 2028 as a percentage of revenue for both AbbVie and Merck. Using valuations attributed to both AbbVie and Merck, it appears that ANIP's current business is worth between $3 to $4 billion, possibly more with Corti's patent protection. This excludes Tezruly, and the other two NDAs which should be assessed on average at approx. 2.5 peak sales for the three drugs.
The two million prescriptions is about half the 4 million estimate in 2011. With safety data, it should not take long to get back to 4 million prescriptions and climb much more, if approved for other indications.
Thanks Silv. Too many coincidences, for it not to be planned.
Thanks Silr.
If Merck is acquiring ANIP, I bet CG Oncology backs down and honors the Biosante deal, especially since they are in trials using the combination of Cretostimogene and Keytruda.
Brusselsspirit, I could be wrong on the price, but the current drug is a generic drug and not marketed. Likely 80% to 90% less than the branded drug with no competitions, which is what ANIP Oral solution Hydrochlorothiazide will be. The $130 price takes this into consideration along with the normally higher cost of solutions over capsules.
Keep in mind the capsule or tablet will be the most prescribed form of the drug. But an oral solution should capture a portion of the market who can't swallow capsules or tablets. It targets people with dysphagia, a high percentage in nursing homes, hospital settings.
It also paves the way for future R&D on oral solution combination drugs involving Hydrochlorothiazide.
The $250 million potential market assumed a 5% market share and does not consider ex-US sales either.
In the end I may be wrong in my assumptions, but I hope this helps you understand my reasoning.
JMHO
Dew Diligence, another reason I believe ANIP is being acquired is that ANIP currently has 33,333,334 authorized shares. In their 2024 Q2 10-Q filing they reported having 21,030,069 outstanding shares. In their most recent S-8 filing ANI Pharmaceuticals, Inc. Amended and Restated 2022 Stock Incentive Plan, they reported that “the aggregate number of shares of Common Stock that may be issued or transferred under the Plan was increased and shall not exceed 6,510,000 shares” The $316.5 million senior convertible note offering sets aside a maximum of 5,547,246 shares of the Company’s common stock may be issued upon conversion of the notes. This leaves ANIP with 246,019 shares for future business development.
Their HQ moved, or is moving, to Princeton, NJ, their shedding of one of their pharmaceutical plants in Baudette, they provided limited info on the three NDAs, including drug types and indications along with PDUFA dates. It looks to me like a buyout offer most, likely by the company funding the regulatory process for an NDA (believed to be the first FDA female testosterone drug), has been accepted by the BOD. Especially, since they have yet to announce the approval of Tezruly, which appears to be the first approved oral solution for an alpha-1 blocker in the world with patent protection in the US until 2041.
JMHO
Simply Wall St. estimates fair value for ANIP is currently $217.46 PPS. According to Simply Wall St's Fair Value is calculated by using thousands of data points from companies with similar market capitalizations, profit margins, growth rates, risks, etc to understand how the market is valuing those companies with similar metrics.
I believe the last time I looked they estimated a fair value in the $150 to $160 range (not sure of the exact value.) So it looks like they have assess Tezruly's approval to be worth over $50 a share. Hydrochlorothiazide approval is probably worth another $50 in PPS. What is a fair value when Libigel gets approved.
SWS Fair Value
How SWS uses DCF to assess fair value
I am wondering how SWS fair value compares to buyout prices. Hopefully it is close.
My $300 PPS buyout estimate might actually be low, when considering that BlackRock has a $159.4 million stake in ANIP and only a $54.4 million stake in SPRY. SPRY keeps their investors informed on approvals and recently gained FDA approval for Nefty (nasal spray of epinephrine). SPRY's market cap is slightly higher than ANIP's yet they have no sales and have yet to earn any money.
SPRY is up 34% since they announced Nefty's approval August 9th.
Bagel, you assume that ANIP's price won't rise between now and when the offer is announced. Deals are usually based on peak sales on the longevity of of sales a peak levels. Where as we have seen PPS can be manipulated.
I believe the institutions keeping PPS depressed, as they accumulated shares will likely drive the PPS north, with little volume required,.to a position where the buyout is at a 200% premium over the the PPS at the previous days close.
It doesn't take much to let this run to $100. Then a $300 offer does not seem insane.
JMHO
North, we should find out soon if patience is indeed a virtue.
Good Luck.
BB, if it is a fair buyout amount with full disclosure, It will get approved and expect they will pay out all shares and ANIP will be delisted. This will allow them to retire the Sr Convertible Notes by paying off principal and interest.
On a side note, as a measure of comfort. Consider that in Stepn Carey's Bio, during his tenure at Par, he supported the company during its 2012 $1.9 billion leveraged buyout with TPG Capital and ultimately, its sale to Endo International plc in 2015 for $8 billion, a three year return. Imagine what MVP is looking for.
Bagel, if ANIP has accepted an offer to be bought out, they will have to fully disclose the relationship regarding the deal. ANIP's downfall is their ability to show they have long-term growth potential. The info regarding the NDAs including the name of the drugs (including first female testosterone). will put that to bed. They have the fiduciary obligation to be act on behalf of the investors. The partnership has to be disclosed and how long they have been working together. Shareholders have a right to have all the information before voting on a deal. Failure to do so could be construed as a conspiracy to defraud investors. The beauty of conspiracy offences is that they can still be charge without being successful in a conspiracy. It is not a position that any of them want to be in, so it will be a fair, but probably not the highest offer they could have received had everything been disclosed from the outset. .
MVP bought ANIP in 2004, They have been invested for 20 years they expect a big payday. I believe their initial investment was $15 to 20 million for ANIP 20 years ago. S&P has ad a 10.16% annual return during this period. Given what they have been sitting on 20% annual return investment over 20 yrs is reasonable, which works out to approx. $300 PPS. So it might not be as far fetched as you think.
JMHO
Roddy, ANIP is lightly covered and ANIP has held back information from the public (cardiovascular and breast cancer reduction, who their partner is), no doubt bound by an agreement contract. This includes holding back info on the NDA filing, such as not announcing PFDUFA dates or what drugs are being filed for and the patent protections . This has allowed companies like Blackrock and Vanguard to obtain approx. 4.1 million shares and counting.
JMHO
Bagel, it is hard to say. We are still speculating that this will happen. But we know they are acting like a company about to be bought out.
The change of HQ to Princeton, NJ makes sense, as ANIP is becoming a global company. LeadIQ uses AI and must have access to info that point to the Sr Executive team no longer being part of the leadership, which point to ANIP becoming a subsidiary of larger pharma company. Especially, as they hold back on material info which could benefit shareholders and shedding a manufacturing plant.
I believe they have the FTC approval for the deal with Alimera. Their vote is September 4, 2024. So we will probably see the deal close shortly after the vote.
I am assuming the PDUFA is for sometime in September, which we believe to be for female testosterone. So we may see an offer come on the heals of an approval.
PPS is hard to say until we see what indications the drug is approved for. HSDD alone, or other indications. We might be looking at $2.95 and $3.75 billion, excluding Libigel.
Libigel must be viewed as drug that ANIP (BPAX) made the CV discovery but likely the partner made the breast cancer discovery. Will alzheimer be considered in the evaluation? Had ANIP taken it all the way to approval 2.5 X peak sales would be normal, but in this case it might be closer to 2X peak sales Testosterone patent protection also remains a mystery beyond 2033. Something else to consider BAPX sold for $144 in the summer of 2011 and tanked when placebo effect occurred. and traded in the $90 in the days before it crashed when all they were looking at was HSDD. What premium is to be paid for keeping quiet for 12 years on the CV risk reduction discovery.
I expect the will offer $7 to $8 billion plus CVR of up to $4 billion based on sales of Libigel. Probably looking at between $300 and $400 a share and up to $200 in CVRs based on 5% of net sales of Libigel over the next 10 years.
It is likely worth more, but this is likely what the BOD would accept.
I expect share price to continue climb on Alim deal and Tezruly announcements news to approx. $120. FDA approves Libigel and the offer comes in at +200 % premium + CVRs. If fully paid out you are looking a $12 billion deal. If Merk is the partner they said they were looking at deals between $1 - $15 billion, so the overall deal could be closer to $15 billion, but I expect they to would also use CVRs .
JMHO.
Correction:
The notes can only be converted after June 1, 2029, unless certain events occur.
ANIP can redeem the notes after September 1, 2027.
A fundamental change (such as delisting after a buyout) allows ANIP to reacquire the notes.
Looks like Alimera votes one the buyout on September 4th, 2024.
Sec Filing
Thanks Silvr, I agree that the difference in disclosing court matters between ANIP and CGON is quite a contrast. Could be a lot of news coming regarding ANIP.
Looks like ANIP is all in on this pending buyout. As of June 30, 2024, ANIP had 21,030,069 outstanding shares. In there S-8 Restated Stock Incentive Plan filing, the plan had 6,510,000 shares registered for issue. Now the Senior Convertible Note Offering the has an initial maximum of 5,547,246 shares for conversion.
The notes can only be converted after September 1, 2027, unless certain events occur.
Combined this totals 33,087,615 while ANIP has a total of 33,333,334 shares authorized to be issued, Not much left to play with.
Looks like the intent is to have the acquiring company pay off the notes before September 1, 2027, but have taken steps to minimize dilution up to a PPS of $114.02. I am assuming this would be needed if the deal did not go through.
Thanks North. If am reading it correctly the deal only only become dilutive after shares hit $114.02, due to the caped call transaction they entered into.
Samy owns many companies, many of which are interconnected. Esjay, SS Pharma for two are expanding and he likely needed some of the money to keep up with demand. MVP who were in on testosterone from the beginning have not been selling. Early last year they had to sell due to liquidity regarding their other investments.
Silvr, a lot of the under $5 billion deals have been for earlier stage development. A $5 billion deal would be for a drug that is just approved with peak sales of approx. $2 billion, no infrastructure and no manufacturing capabilities. When looking at peak sales, in a buyout, Corti alone, is likely be worth $1.25 to $1.5 billion. Tezruly is likely worth $0.5 billion to $0.75 billion same for hydrochlorothiazide. The rest of their business is likely worth $0.750 billion. That works out to between $2.95 and $3.75 billion, excluding Libigel. A deal for the whole company should far exceed $5 billion. How much will be dictated by the indications.
FYI, according to Merck's earnings transcript.
Hard to say how it will play out. But we should start seeing PR soon. The Senior Convertible note offering should close tomorrow. Still a lot of volume, so we should several days of steady PPS increases until big news is dropped.
According to Linkedin, ANIP appears to be selling the Baudette Containment Facility located at
Headquarter and remaining locations
455 IDC Road
Baudette, MN 56623
Phone: 218-634-3500
Fax: 218-634-3540
Overview
47,000 square feet Containment Facility
32,000 square feet of manufacturing, packaging, and warehouse
100 nano-gram per eight-hour time weighted average maximum exposure limit to ensure employee safety
Low-humidity suite for processing and encapsulating moisture-sensitive compounds
15,000 square feet of employee, office and mechanical space
Capabilities
Fully-contained high potency facility with capabilities to manufacture hormone, steroid, and oncolytic products
DEA Schedule III capability
Capacity
Tablets ~2.5 billion doses/yr
Capsules ~150 million doses/yr
Liquids ~3 million bottles/yr
Topicals ~2 million tubes/yr
Looks like acquiring company does not need the facility.
Pfizer is another potential acquirer. It's head office is a 73 minute drive away.
- Matthew Leonard who joined ANIP's BoD in August 2023, and in December 2023 he was hired by Pfizer as Senior Vice President, Global Access and Value, where he is accountable for leading affordable and sustainable access for patients globally across the Pfizer portfolio.
- Rare Disease and oncology are two areas of focus.
- They manufacture Testosterone API.
- Elizabeth Powell ANIP's Chief Compliance Officer And Head Of Legal, Rare Disease who came over from Merck, according to Leadiq, appears to be operating out of Michigan, while her Linkedin profile still has her located in Fort Washington Pennsylvania.
- Pfizer's largest manufacturing facilities, including injectables, are located in Michigan.
The following info has been held back since the CVR's expired and Samy started selling:
1- Approval for Sunova, the only Hydroxychloroquine tablet authorized for use in pediatric patients weighing between 23kg and 31kg. (Marketing start September 15, 2023.
2- Three 505(b)(2) NDAs submitted no info on PDUFA dates or what drugs are involved.
3- That one of the NDA's submission fees was paid by another company.
4- Tezruly's approval and a tentative launch date.
5- Their headquarters in moving to New Jersey.
6- Selling of one of their manufacturing plants,
This only what we have been able to uncover, so far.
I find it interesting that Samy started selling shares a couple of days after the Libigel CVR's expired.
Samy's trades
That is possibility.
I may be wrong, and personally would like to see ANIP not be bought out,
However, moving their headquarters to Princeton (yet to be announced) and current CEO, CFO and other senior executives not being included in the move to the new headquarters, when combined with what lack of informationrregarding three NDAs which were submitted, one of which was paid for by another company (not announced or identified by ANIP), in my opinion, points to a buyout.
If I am right, looking at the structure of the offering, it looks like it was set up as a defensive move to avoid scuttling the buyout.
The first payment is not due until March 2025. If all goes well the buyout may be completed by then and all they will do is have the acquirer pay back the principal and interest.
Regarding Patrick Walsh, he is an operating partner with Ampersand Capital Partners from which ANIP obtained $25 million in PIPE financing. He not only has fiduciary duty to shareholder, he also has a duty to his partners. I expect we get a fair for ANIP.
According the Q2 10-Q filing: