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It definitely works. Part of the problem is shown with Ms. Burson's attitude. She can't do the procedure, so she doesn't want to have anything to do with the implant. These addiction counselors are a big problem. Scared that implants plus free NA meetings = no business.
Yeah, weird thing is they all vest this year, rather than over a couple of years as with past grants.
If a takeover was coming, it wouldn't matter because all options vest on change of control.
So why give the accelerated vesting? Perhaps to they can take the accounting charge all in one year? Who knows.
Yes. It might be a reward for something that hasn't been disclosed.
The board granted Sunil and Rubin 170,000 options at $0.96 per share, all of which vest this year.
Usually options are issued for a job well done. Not really seeing that here.
Maybe they are accepting options in lieu of a salary? If not, I see not justification for giving guys options who have driven the stock price down to this level.
https://www.sec.gov/Archives/edgar/data/910267/000114420418013890/xslF345X03/tv488108_form4.xml
The whole website makes Braeburn look so bush league
Braeburn didn't have anything like this...$5 co-pay to get sublocade if needed.
https://www.insupport.com/specialty-product/specialty-pharmacy/copay
I have no idea.
Abstract for ficlatuzumab and cetuximab for head and neck cancer
http://ascopubs.org/doi/abs/10.1200/JCO.2017.35.15_suppl.6038
Abstract for tivozanib for inoperable liver cancer
http://ascopubs.org/doi/abs/10.1200/JCO.2018.36.4_suppl.364
I agree the current market cap valuation is ridiculous given they have an approved drug that, if priced appropriately, would sell something.
Their problem is cash. $11.6 million as of September 30th, and probably $3.0 million of operating expenses in 4Q took them to $8.6 million. In 1Q, another $3.0 million of operating expenses plus the $3.0 prepayment to Horizon leaves them with $2.6 million on March 30th, not enough to get through the end of 2Q.
Press releases on other development programs are fine, but all that really matters right now is getting rights back from Braeburn, and raising enough cash to last for a year or so.
If there is no deal, they will have to issue shares to keep out of default of the Horizon agreement...over 10 million shares at least.
Following Braeburn's CRL and firing their sales force, the lender didn't see how Titan would pay off the loan, so threatened to foreclose unless there was a payment plan. So, Titan basically paid back half the loan and needs to come up with a plan for a $10 million equity infusion by May.
Well, hopefully its good news! I know they should have data on ropinirole soon and maybe something on the deal with Opiant.
The thing that worries me is the rumor they are sticking with Braeburn.
Amen. Along with the restrictive REMS, insurance companies preauthorizations and government mis-spending, you have an entire counseling industry spewing falsehoods about MAT because they are afraid of losing money.
Chatter on cafe pharma that Braeburn will keep probuphine, but that Titan has insisted they fire all the reps and start over.
The lovely people at Indivior are making their presence known now that their injectable has been approved. United Healthcare has just added additional screening criteria for probuphine, stating orobuphine is not medically necessary for "Patients who are recently tapered to a lower dose of sublingual or transmucosal buprenorphine for the sole purpose of transitioning to Probuphine."
So you want the implant, and you taper down to get it, but doing so makes the implant medically unnecessary for you. No doubt in my mind Indivior is behind this.
https://www.uhcprovider.com/content/dam/provider/docs/public/policies/mpub-archives/comm-plan/community-plan-medical-policy-update-bulletin-february-2018.pdf#page=12
Bimagrumab (BYM338) is Novartis’ ActRIIA and ActRIIB inhibitor, currently undergoing clinical trials for sarcopenia. It is promising, but it has struggled in the clinic. I think the Cell.com article shows that Novartis has found BYM338 prevents loss of lean body mass, but does not prevent anorexia in sarcopenia…it requires a GDF15 inhibitor to prevent anorexia. Aveo’s Av-380 (licensed to Novartis) is a first in class GDF15 antibody. I think we will see more on this in 2018...
"Appetite reduction and muscle loss are all symptoms of the frailty of old age, marked by sarcopenia. The findings in this study suggest that in settings in which elevated levels of GDF11 are observable, restoration of appetite and weight gain may be relieved by inhibition of GDF15, but full inhibition of cachexia—loss of muscle, in addition to loss of appetite— requires blockade of the GDF11 receptor system, such as by inhibiting ActRIIA and ActRIIB"
Mice with Av-380 alone did not lose weight, but lost lean muscle mass.
Mice with BYM338 alone did not lose lean muscle mass, but lost weight.
I'm new to AVEO, and still doing my due diligence, so I'm probably not the best person to ask about the investment merits.
The stuff I posted was basically what I couldn't find out from their public filings regarding their pre-clinical or early clinical development programs (i.e., excluding Tivozanib).
If I had to handicap likely ROI, I don't see much coming from ficlatuzumab or Av-203. But, all development expenses are being paid by the licensee, and Aveo has retained all US rights to both drugs. So if they were to pass Phase 3 development, each of them alone would be worth the current market cap in my opinion.
Av-380 appears to have the most realistic potential. Apparently, Novartis' bimagrumab (which the FDA granted "breakthrough drug" status in 2013) has struggled in Phase 3 testing. The Cell.com article I posted shows Novartis research that along with bimagrumab, a GDF15 antibody (Av-380) is needed to effectivly and completely treat cachexia. A huge market in both cancer and aging in which Av-380 would likely be a billion dollar a year drug, and a first in class therapy in Av-380 that would likely also receive breakthrough or accelerated approval status. I would guess Av-380 is nearly ready to enter the clinic, and so in terms of near-term catalysts a IND filing and/or Phase 1 in 2018 (with a first class partner like Novartis) would move the stock substantially upwards in my opinion.
Av-353 appears to be a dream: first in class therapy involving Notch3 signaling that reverses PAH (all other therapies appear to only treat symptoms.) The market is substantial ($4 billion), and Av-353 has the potential to be a billion dollar drug. Pre-clinical work at UC San Diego has been done with mice, and is currently being done with pigs. That study should be published in 2018, and then I would assume it also will be ready for the clinic. There currently is no partner, which to me is the red flag. If this really is so great, why isn't anyone leaping in? Of course, a partnership deal signed on attractive terms would push stock price up as well.
The others on this board can speak to tivozanib much better than I can. If approved in 1st and 3rd line kidney cancer treatment, I think it can capture a respectable market share, but I'm not really sure how much. If it is shown to provide a value added affect in use in connection with other therapies (e.g., Tinivo trial), I think it has a lot room to grow because its side effect profile is so superior.
In any event, I think most investors are myopically focused on TIVO-3 results coming in the 2Q, and we should see a jump up in price if positive results are released. That should also be supported by $8 million in EU milestones from pricing approvals for tivozanib and a likely $20 million r&d reimbursement coming from EUSA Pharma in order to use TIVO-3 data.
Personally, my belief is that if TIVO-3 results are positive, AVEO is likely to be bought out. But I think its a mistake to assume valuation will be based entirely on tivozanib, as any acquirer will also receive (a) 100% of US rights and a significant potential ex-US royalty stream in Av-203 and ficlatuzumab, (b) potential for huge royalties on Av-380, and (c) 100% of worldwide rights for Av-353.
Latest on AV-380
Feb. 2018 Study Av-380 with Novartis’ Bimagrumab
http://www.cell.com/cell-reports/fulltext/S2211-1247(18)30076-7?_returnURL=https%3A%2F%2Flinkinghub.elsevier.com%2Fretrieve%2Fpii%2FS2211124718300767%3Fshowall%3Dtrue
2017 Cachexia Conference: See Glass (Novartis) and Breit (St. Vincent’s, Aveo’s licensor)
http://society-scwd.org/wp-content/uploads/e_prog-cachexia-Rome2017_2017.11.29.pdf
Latest on AV-353
Inhibition of NOTCH3 Cleavage Reverses Pulmonary Arterial Hypertension in Animal Models, UCSD Researchers Find
https://medschool.ucsd.edu/som/surgery/news-events/Pages/Pulmonary-Arterial-Hypertension-Research.aspx
Abstract 12164: Inhibition of NOTCH3 Cleavage Effectively Reverses Pulmonary Hypertension in Rat and Mouse Models of Disease
http://circ.ahajournals.org/content/134/Suppl_1/A12164
Latest on AV-203
December 2017 IND for Phase 1/3 in China
https://www.prnewswire.com/news-releases/canbridge-life-sciences-submits-investigational-new-drug-application-for-can017-trial-in-esophageal-squamous-cell-cancer-escc-in-china-300574477.html
Latest on Ficlatuzumab
Pancreatic Cancer (Dana Farber Institute)
https://clinicaltrials.gov/ct2/show/NCT03316599?term=Ficlatuzumab&draw=2&rank=4
Neck Cell Cancer (U of A)
https://clinicaltrials.gov/ct2/show/NCT03422536?term=Ficlatuzumab&rank=5
AML (UCSF)
https://clinicaltrials.gov/ct2/show/NCT02109627?term=Ficlatuzumab&draw=2&rank=1
No, they are scared MAT will kill their "counseling" business.
I think Sheldon (Braeburn's old CEO) believed in probuphine; she did a lot at promoting it. Unfortunately, she just wasn't prepared for the launch, and thought training doctors=sales, which wasn't the case. Also, they weren't prepared for the resistance from insurers.
Mistakes happen (at least to me), and they could have corrected a lot of things. But when Apple Tree pulled the Braeburn IPO, I think the decision with Apple Tree was to gut probuphine. So Sheldon got fired, and Derkacz comes in only talking about CAM2038. They fire half the sales force in July of 2017, and then don't begin to even start interviews to replace them until December (in preparation for the injectables launch).
Titan clearly did not know what the heck was going on. They seemed as if they were afraid to ask. It kinda sounds like Braeburn was just ignoring them.
Hate to keep saying it, but a Chapter 11 BK would allow Titan to force a termination of the license agreement, but preserve Titan's right to sue for past breaches of the license agreement. A lot of companies emerge from BK stronger, without screwing over stockholders. I remember American Airlines going from $1 to $7 within six months of their BK.
Interesting. I don't think they will get a nickel from Braeburn without a lawsuit, and a lawsuit just delays things, so hopefully they can negotiate something quickly.
Wouldn't be surprised if they don't have an earnings call in March, and just issue a press release. Given all the dramatic developments, they are probably better off saying as little as possible right now to avoid stockholder suits.
True...worldwide rights to probuphine would bring a higher price.
?
So, it's the 15th and no license agreement?
This wouldn't seem to be that difficult. Either it's signed and they are waiting to announce it, or Molteni wants to delay signing until they see how the Titan-Horizon thing plays out (no sense in signing a license agreement, paying $2.4 million, and then having it all go to Horizon in a BR plus lose the license rights).
They made some bad decisions, but how about Titan's decision to out-license to a partner with no sales force. At the current price for probuphine, I really don't think a couple of extra years would have helped...insurers just don't want to pay for it.
But, keeping our eyes on the prize, Pro Neura has been validated, which is most important. Parkinsons and thyroid markets will be more receptive to new technology that improves quality of life, and patients are much less difficult.
Really though, how long will it take Titan to get approval? They just got the Parkinson's Phase 1/2 started after four years of waiting, and T3 has been in preclinical hold for two years. They don't have the money or people to do the job...they need to sell.
I'm guessing Rubin (not Sunil) is smart enough to see that.
I've been thinking about that. Titan has the right to get back the rights to probuphine, but what about product literature, the REMS plan or even the tools used to insert the rods (remember, Titan had to come up with their own for ropinirole because Braeburn wouldn't let them use its design). Braeburn probably wants something for all that stuff.
Yep, it should be signed up anytime now. $2.4 million, which will come in handy.
Molteni?
Term sheet signed in November states: "This Term Sheet and any attachment hereto constitutes a binding obligation on both Parties to enter into, execute and deliver a definitive agreement containing the essential elements set forth herein, as well as any additional agreement necessary in relation thereto by February 15, 2018 or such later date as may be mutually agreed in writing by the Parties"
So I guess this one comes down to the wire also?
It is overpriced. Braeburn was too worried about not making imaginary dollars rather than making the real money that was within their grasp.
According to the Form S-1 Braeburn filed in 2016, the cost for four rods was $600. I think the cost is currently around $5,200, so the mark up is $4,600 or 660%. You have to subtract from that Titan's royalty (15% or $780) and whatever the speciality pharma is charging them (say 5% or $260), so their simple gross margin is $3,580, or around 496%.
I can't remember exactly, but I think Indivior has about a 100% gross margin on suboxone.
Indivior has priced sublocade more expensive than probuphine, but they can afford to wait and see where the market settles while living off suboxone revenue.
In the EU, the government will set the price. One of the milestones is actually coming to agreement regarding pricing with the government. It will allow Titan/Molteni to get a solid single or double out of each sale.
In US, Braeburn tried for a grand slam home run on the price. No one purchased. It's hard to find a pharma company equipped to do buy and bill in addiction who is going to be interested in a single or double...they all want the home run.
It's $6 billion over two years. Not clear where it will be spent.
By the way...Indivior (and Braeburn) are going to have the same problems trying to sell injectables. I'm laughing at all the "game changer" headlines about sublocade.
The only winning strategy would seem to be for Titan's new partner to come in and sell probuphine at a price equal to suboxone. But even in that case, what will insurance companies do when 90% of oral bupe prescriptions are not refilled? An implant would mean 100% certainty of paying for 6 months of care, while a prescription means you only will have to pay for 10% of that amount. It's cheaper to let people die.
I doubt BK would happen. It's a useful tool, and a lot of companies have used it to their advantage, but it would also allow the court to reject all contracts...including employment agreements, etc. You follow me.
Although I would feel like a moron for selling, the best thing that could happen right now for Titan is a complete buyout. I'd be happy for you guys, because the dilution that an equity raise at these levels would cause is just not fair to existing stockholders. That's why I'm sitting this one out on the sidelines for now...but I may end up a loser (price back up to $1.20 today).
The biggest mistake I made on this investment was over-estimating society's compassion. I really thought insurance companies and medicare/medicaid would happily cover probuphine. Boy, was I wrong.
Funny you mention the "B" word...if Braeburn is playing hardball, it might actually make the most sense for TTNP right now.
Let's say Titan has: (a) an investor willing to put in $10 million, and (b) a partner ready to enter into a deal on probuphine, including a sizeable upfront license fee, but both are contingent upon 100% of probuphine rights being returned to Titan.
Let's also say Braeburn is holding up the process by demanding a percentage of future royalties or to be paid back their R&D expenses. Litigation over termination of the license agreement could take two to three years: time which Titan does not have.
Titan could file a prepackaged bankruptcy under Chapter 11 asking the court to approve a plan whereby: (a) the Court uses its bankruptcy power to "reject" (i.e., terminate) the Braeburn license; (b) the Court authorized Titan to enter into a new license agreement with its partner; (c) the court authorizes an equity infusion, and (d) a portion of proceeds of (b) and (c) are used to pay off Horizon.
Bankruptcy is 100% different than normal court proceedings. All the traditional rules are thrown out. Such an action by Titan would trump any leverage Braeburn currently has. When Braeburn has fired their entire sales force, they cannot argue to the Bankruptcy Court that their license should not be rejected by the court.
Titan could them emerge from bankruptcy a much stronger company. Dilution would be no worse than it would have been if they did not file for bankruptcy.
So the question comes down to how likely is a partnership deal by May 14th.
In terminating the license agreement, Braeburn will receive the benefit of not having to pay Titan up to $50 million in license revenue from sales of CAM2038 when it is eventually approved. So I think they are incentivized to move quickly, but perhaps not that quickly. Titan has about another quarter of revenue left in its treasury, although a Molteni deal might bring in another $2.4 million. The longer Braeburn waits, the more pressure Titan is placed under to concede to whatever they are asking for in order to get the rights back on a timely basis.
Horizon has agreed to forbear from declaring Titan in default under the "material adverse change" provision of the loan agreement until May 14th. Anything short of an entire pay off of Horizon would be unwise, as Titan would be under the constant threat of them foreclosing on the loan. So I think Titan needs to raise enough to pay off Horizon in full ($4 million) and fund its operations for the next 12 months.
Perhaps Titan will secure a partnership involving an upfront payment plus an equity infusion, killing two birds with one stone.
Just a guess, so it might be a lot sooner.
I may be wrong, but what the situation says to me is:
1. If there is no partnership deal by May 14, Horizon wants to be repaid in full through Titan doing a $10 million offering. Titan could do a smaller, $5 million offering and repay Horizon $1 million, but the day after that is done Horizon could declare Titan in default under the material adverse effect provision in the loan agreement.
2. If there is a partnership deal by May 14 that provides enough cash to last for awhile, Horizon is requiring Titan to prepay only an additional $1 million through an equity offering of $5 million.