There are lots of royalty-only companies that are publically traded. Look at this way. This is a straight licensing deal with Takeda and is quite similar to those deals between companies that have completed phase 3 trials, but don't want to market the drugs themselves. It's as if we're going back in time without the overhanging safety issues.
"Responsibility for All Manufacturing" suggests to me that Takeda is paying the bill, or accepting responsibility for the $40 million owed to the supplier of the API and packager of Omontys. If this is the case, then AFFY's balance sheet has been tremendously strengthened. The shareholder lawsuits will eventually be settled and then the Company will do a reverse merger with another Company.
While AFFY transferred all rights and responsibilities re:the Omontys recall and possible reintroduction to Takeda, what was not disclosed is AFFY's major financial obligation to the manufacturer. The supply agreement may be as high as $40 million. If Takeda did indeed absorb this obligation, then the is a buy at these levels. I'll bet that Takeda is responsible for this supply agreement, but I may be wrong.
Looks like they're going back to square 1, which is a straight licensing deal. Royalties are within range, while the milestones are a little small. It's as if we're negotiating a deal prior to FDA approval for exclusive rights to big Pharma. What I found most interesting in this 8K (aside from the time of the release, which Edgar screwed up) was the marketing opportunity in Japan. Up to now, Takeda had held back on applying for commercial sale of Omontys in Japan, partly because Amgen had everything tied up with the renal care distributors. Today, it appears that Japan is the major part of the licensing deal. I either case, this works for Takeda in that they get full control of the drug without having to pay more than minimal amounts prior to potential reintroduction of the drug. Takeda, having deep pockets, will and would be sued in any event, so taking full responsibility for the recall and investigation has no bearing for them. Affymax, on the other hand, is relieved of the responsibility of investigating the root cause of the Omontys hypersensitivity reactions. They can operate in damage control mode without bleeding any more cash. The class action lawyers will try to go after the remaining cash, but this will be held up for a long time. If they can preserve some cash and keep a clean shell without having successor liability tied to the corporation, then they can reverse merge with another company. I think it's worth a buy under a dollar. No one benefits from a bankruptcy at this point, not even the creditors or bounty hunting lawyers.
I agree with you. I admit I lost money this year (and previous years) buying too early. The carnage we've seen this week is not limited to TINY. I think there's been alot of redemptions in funds to pay taxes and they sell the small cap stocks first. But that's besides the point. There are two white hot events in their hopper. One is the attention placed on their investment in the Quantum Computer Company (perhaps they'll buy others in this area) which has seen validation by Lockheed. The other is the successful phase 3 trial by Amgen in their investee company, Biovex. amgen knows how to get drugs approved and TINY stands to get another $9 million in milestone money in the next few years. Their overhead is way too high. They spend far too much time worrying about their own compensation and talking about it. They have no business holding stocks once they go public. They need to get results on creating a fund to manage other money.
Rx Numbers for Gralise were flat but didn't warrant this kind of selloff. Perhaps an institution sold a chunk and leaned on the stock quickly. Roth Capital needs to update their reports to put Serada risk out of their equation. They give it zero value, but still give it an imputed FDA risk (even though funding has been discontinued).
One never sees this type of valuation in biotech, unless the market it addresses is large. Of course, we all know about the recall. However, this is not an orphan drug for just a few thousand patients. There's billions of dollars at stake for both Amgen and Johnson and Johnson. I'll bet Takeda has hired a forensic pathologist to see if there was any monkey business.
There's nothing immoral about being an opportunist. Even those who are negative about the Company have to admit that this has been a great trading opportunity this week and some like myself, haven't sold yet.
While the safety issues revolved around anaphylaxis, the targeted patients are among the most fragile population (i.e. kidney disease). Side effects are more deadly in this group of patients. Moreover, other pegylated drugs that have been on the market for a long time have similar safety issues, so I doubt that the FDA will nix the entire category of PEG-based drugs. They just want to know if there's a causative agent beyond the expected source of concern.
This is a serious recall and if not handled properly, corporate officers from both companies, including the Medical Directors, would be personally liable. Even if they were to go BK, they would still have to work with the FDA in finding the causative agent that may have precipitated anaphylaxis. This Company will not be shut down overnight. There are separate disclosures for the public safety and for shareholders. They all know that safety comes first. If they handle this responsibly, the FDA will reexamine a pathway forward.
No, there's lots of supply right now, but eventually, when the shorts get tired and move on, the overhead supply will exhaust itself.
It will take a few of these 20 million share volume days to exhaust the overhead supply under $2. Once the stock hit a buck, traders were scalping for an intra-day 20% gain. Can't blame them. Looks like the high frequency boys are playing here today too.
One could see the manipulation in yesterday's post-market and today's pre-market trading action.
Novartis is on their radar as is Roche. These companies have the resources to bring an EPO type product to the market and circumvent Amgen's patents. (with a little help from AFFY).
When the heavyweights get involved in cancer vaccines, it's good for the gander.
We've witnessed a nearly huge change in ownership twice over the past month. Institutions are out, but hedge funds are in (on both sides). Extended trading smacks of a little manipulation,
He pointed to the 12 - 18 month window (they announced a desire to do so around 12 mos. ago) that is customary in the vc industry. They obviously need to earn management fees to offset SG & A. Some nice new additions to their life sciences portfolio, including one in AgBiotech. I remember when Ag was 20% of the biotech stock index (15 years ago). Amgen just announce a positive phase 3 trial result last night from portfolio company, Biovex.Also, there are now two funds dealing with private Quantum Computing companies., including yesterday's announcement of the former CEO of Blackberry/RIMM starting a new quantum-based fund. They got theirhands full. It's time to execute without glossy disclaimers.
I don't know what the long-term outlook for this Company is, but based on its recent trading history, as soon as the shakeout ends, we should have another last gasp spike, which may be good for a trade. I don't see them filing BK for many months. They just retained a banker, who will look to auction off pieces while they're alive. BK is only a last resort. The negative announcement was designed as much to keep their creditors at bay and preserve cash as it was to warn shareholders about the risks associated with buying or holding the stock.
Looks like someone wants to keep the share price above $1 to avoid a delisting headache.
I think Takeda wants to get rid of it and pay attention to their other products. It's a big headache for them. Takeda has the marketing rights, but AFFY still holds the license to the i.p.