goatroper, nothing would prevent a big pharma from buying out CLDX at that market cap, which would amount to about $15 per share. You are correct that CLDX is extremely vulnerable to such a hostile takeover. What is more, I believe enough institutional owners are terribly upset about the low share price and the failure of Rintega despite all management's assurances that they would be happy to cash out for $15 per share (even taking a loss on having bought higher, if they did) just so they can sell the company out from under Marucci to spite him. All it would take is the top six or seven institutional owners (totaling at least 51% of shares) to collude in the sale and the company could easily be sold next week. Management allowed the poison pill to expire in November 2014. CLDX is more of a buyout play than a commercialization play right now. Management would be powerless to stop the buyout. Vulnerability to that is quite high indeed.
What would be sad about such a buyout is that it would value CLDX at less than what MEDX was stolen for when it was bought by BMY, and CLDX could very well have in Varli a treatment that is five or ten times more valuable than anything BMY got from MEDX. Management has some business sense; it knows how vulnerable it is right now. It would probably be wise for them to be exploring a partnership deal that would make it less attractive for another company to initiate a hostile bid, say a deal in which BMY takes a 25% equity position in CLDX in exchange for a cash infusion, shared costs on all future Varli development, and 30% royalties on Varli sales if it ever gets approved.
Second line Rintega is not worth pursuing. Not enough patients to treat (not enough in sales potential) to justify the cost of another trial. Maybe years down the road, if Celldex has billions rolling in from Glemba and Varli sales, then you could justify spending money on another Rintega trial. Not right now.
Yes, weight, you have a point. Rintega was never espoused nor thought to be a lucrative drug. It's strategic importance in the company's development was that it would be the first to launch and provide a revenue stream to fund further progress without having to raise more money in disadvantageous ways.
Now the company is relying on success with Glemba in the METRIC trial to provide the funds that will make the company solvent. Plus Glemba would bring about triple Rintega's once projected revenues.
As for Varli, unless the phase 1/2 data are absolutely and indisputably significant, don't expect Varli to be a big factor in moving the shre price. It's still too early in development. If the Vari data are ever stunningly positive then, yes, we would see the share price surpass $40 easily, especially if Glemba has already been approved.
At the very least, the board compensation committee should be stingy with the bonuses and the option grants to the executive team this year. Over the past year shareholder value was absolutely crushed and the lead product failed to launch. Why should the executive management team be rewarded for that?
Executive management owns stock option grants for many hundreds of thousands of shares that are currently worthless because the share price is below the option exercise prices.
Here are the option grants awarded to Marucci over the past several years showing shares and exercise price. Other top executives were awarded a smaller number of shares but at the same exercise prices.
2015: 280,000 shares at $25.41
2014: 280,000 shares at $13.45
2013: 280,000 shares at $16.36
2012: 280,000 shares at $5.69
2011: 157,850 shares at $2.80
2010: 164,000 shares at $4.50
2009: 129,000 shares at $8.52
2008: 254,243 shares at $8.16
Clearly, management has very strong motivations to get the share price back up at least around $20 in order to realize a significant return from their option grants. Every executive and board member is in the same boat as Marucci. Every lower level employee who was granted options is in the same boat.
Management always talks about how patients are the top priority, and that may be true, but don't think for a second that these executives want all their years of toil to go without landing the pot of gold at the end of the rainbow. They want their lucrative financial gains too, and as many of them are entering their near-retirement years they will be highly motivated to get the share price back up to a level where they can exercise their options for a substantial gain.
No executive other than Catlin ever exercised options and sold shares. That tells you how much confidence they had in Rintega's success and the eventual success of the rest of the pipeline. On the return journey up in the share price, though, if executives start to exercise options that are suddenly in the money, that could be a warning sign.
Whether it is through commercialization or a sale of the company, management is going to work to get the share price back up to a level at which they can retire very, very comfortably by cashing out all their options for a handsome gain.
The business strategy going forward after Rintega's failure to launch will depend on what management knows that we cannot know at this time: how Glemba is doing in METRIC patients and how Varli combination trials are going. The METRIC trial is open-label; doctors and management know which patients are receiving Glemba and which are receiving control. Some preliminary estimates about whether that trial will provide a path to commercialization for Glemba in high-gpNMB, TNBC patients should be in hand by now. Management seems to have taken steps anticipating Glemba's commercialization, such as registering trademarks for Glemba brand names (e.g., "Glemva") very recently. If METRIC data are will be in hand in early 2017, and if they support approval, Glemba sales should begin by late 2017. However, that cuts it pretty close to the end of the financial runway, and the share price would be mercilessly beaten down.
That leaves Varli combination data. I believe initial data are slated to be presented at ASCO. If those are good, they could boost the share price. But Varli is still very far out from commercialization.
Assuming Glemba will succeed in launch, the object is to have enough money to get to the point at which the company is receiving revenues from Glemba sales. I don't see how Marucci can securely do that in the current circumstances without partnering either Glemba or Varli and raising several hundred million dollars through such a deal. It would have been nice if the company could have gone it alone, as Marucci had hoped, but Rintega's failure to launch makes that near impossible.
I cannot see a secondary offering being wise at the current low share price.
Management and employees have many, many thousands of shares worth of stock option grants that are underwater. They are motivated to get the share price back up to the $20s for the sake of their own options, even if management is contemplating a buyout. A buyout at $12 per share wouldn't profit them much.
Neshua, shorts weren't right; they got lucky. The anomalous control arm is what saved them. As we've pointed out many times since the news, had the control arm matched every other similar set of patients in medical history the trial would have succeeded. It should have succeeded but for that anomaly. Bad luck.
Let's see in the morning what job openings remain. That might provide a clue about the restructuring and reprioritizing that Marucci has begun to implement.
It is so ridiculous, raymond. When the share price was this low before hardly anyone new Celldex had CDX-011 or CDX-1127. Now CDX-011 is nearing the end of a registrational trial and CDX-1127 is being aggressively tested with, from all accounts, promising early results.
Maybe you're right, biggy. Still, it's hard to get over the stunning disappointment over Rintega's unlikely failure. Management his clearly cut the Rintega cord and is pressing on because Rintega is no longer a wise or worthwhile expenditure.
End of discussion.
shareholder, I believe long_vrts addressed your points in a post that stated KLH might be responsible for doing the work of getting median OS to 20-21 months but the 20% or so of very long term survivors of years and years could only be explained by the activity of Rintega. Immunotherapy treatments take time for evidence of their effect to be noticeable; in the case of Rintega years for the tails in the graphs to emerge that show superiority over standard of care. PFS6 and median OS might not be adequate measures of immunotherapies' best benefits for the percentage of responders that benefit greatly. In that case mean OS or some other measure that included the value of some patients' remarkably long survival would have to be taken into account.
Just kidding. If the high gpNMB TNBC patients in METRIC are doing as well as they did in EMERGE, Glemba will be a shoe-in for approval in that indication and possibly for all TNBC patients.
Of course, Rintega was supposed to be a shoe-in for approval too, and would have been, had it not been for KLH in the control arm apparently performing as an active agent and skewing the control arm's OS numbers higher than any past precedent.
As many have frequently repeated, the METRIC trial is open-label; therefore management knows exactly how well Glemba patients are performing in comparison with control patients. Last patient will be enrolled in 2H of this year with data in the primary outcome (PFS6) available no later than early 2017.
Earlier studies of Rintega in newly-diagnosed patients did not have control arms, so there was no prior experience with patients receiving standard of care plus KLH. Management assumed KLH would be inert when administered in conjunction with standard of care; it seems to have been active.
I bet Tibor Keler and Tom Davis are kicking themselves over such a costly and seemingly boneheaded error in trial design.
On the other hand, if Celldex can turn it into something positive perhaps it could be one of those fortuitous errors that doesn't seem advantageous at first.
Really, anybody who wanted to sell has already sold. Only more bad news would send this down any further, maybe like Marucci suffering a heart attack.
Some treatments have been approved by the FDA for being noninferior to standard of care and having fewer side effects than standard of care. Perhaps Rintega could qualify for approval under such consideration.