If any of these law firms ask a judge to subpoena the 50% data, that OREX has had since October 2014 and finished full review in Q1 2015, than this will most likely become a class action lawsuit. The probability of an ambulance chaser doing this is, virtually, 100%.
That leaves us in an interesting place; does OREX release the 50% data before a subpoena? Are there enough losses to justify legal action?
A judge can subpoena the 50% data. That would be an absolute nightmare for Orexigen if shows regression to mean.
There are more than 17 plaintiffs. This is public information and basic due diligence.
The lawsuits allege that the 25% data was released prematurely and caused a loss. If the 50% data shows regression to mean, most certainly, this is a validation of such an assertion and would lead to settlements.
What happened was OREX decided to use the 25% data on 3/3, prematurely, to strength their patent portfolio on Contrave because they knew Actavis was preparing to file an ANDA. Actavis filed the ANDA on 3/12. Dr. Jenkins, from the FDA, is correct that this was premature and the 50% data will, predictably, show regression to mean. OREX will have to settle ALL the lawsuits.
There are 17 lawsuits. The last was filed the previous week. 2 are scheduled for hearing. If the 50% data shows regression to mean ALL 17 suits will have merit and will be settled. It would cost Orexigen a sizable percentage of their cash position.
It's biotech and a stock with only 52 million shares outstanding. The swings are volatile but this opiate epidemic is real. The numbers do not lie. This stock has a solid management team, only a $422 market capitalization (2017 guidance for Bunavail is $250m reaffirmed twice) and is well positioned for a MAJOR run. Once the supply shortage is resolved and sales return to the strong growth model they were on beforehand that low share count is going to be a tremendous advantage to shareholders. Basic supply and demand.
Not to mention they have a strong relationship with ENDO who released a PR in Q1 that they would be acquiring and partnering with multiple business in 2015. ENDO is handling the Belbuca approvals/launch and Bunavail EU launch. It is only a matter of time before ENDO buys BDSI. In fact, I hope they wait so the price is higher. I have lost profits to early buyouts before.
EXTREMELY STRONG BUY
OREX at a market capitalization of $400-500m would be properly valued, particularly, with the ANDA reshaping the risk profile. That is a pps range of $4.15-$5 a share. At these levels OREX is worth looking at investing in.
Takeda reported today they will have a loss in Q1. Their first loss in 6 decades. They are hurting badly from the Actos fines. Takeda is in ALL OUT cost savings mode, more than any other major pharma in the world. They will not be active in the EU with MySimba and, in fact, I give them 50/50 to abandon OREX altogether if sales do not improve.
bababara00. Jack Lief is known for being one of the best leaders at pipeline development. He has, unquestionably, done a fantastic job in this regard.
$4.0 million net when they had anticipated closer to $30m. Those analysts expectations you cited are ALREADY slashed down TWICE and sales will miss by almost half. More downgrades coming.
Q1 2012 CC Takeda - Contrave 2015 guidance $250m gross - 1st full year. This is an absolute disaster for Takeda. They are trying to salvage what they can and control their losses.
Go perform the due diligence on how much Takeda paid to partner with OREX and listen to the CCs with the guidance/expectations (they were unrealistic and real world sales has unquestionably proven that.). Same with ARNA. That is why Takeda cut the sales force from 2000 to 900 even before FDA approval and why they have delayed DTC (they watched Belviq fail and adjusted as best as they could). Takeda and Eisai have buyers remorse and are both hemorrhaging losses with Belviq and Contrave.
Contrave is $200m below original guidance, sales force cut from 2000 to 900, DTC delayed possibly cut altogether and some foolish investors believe this is going well.
The Qysmia, Belviq and Contrave launches are all absolutely terrible. This launch is nearly $200m less than Takeda had anticipated when they partnered with Orex.