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Thanks for checking...I was wondering when they would be posted.
I wasn't aware of that...good news.
I know we can't look beyond the Ad Comm, but there are just so many potential catalysts...approval of the NDA, the HHS coming out with new DATA 2000 regulations, Braeburn spending $75 million on the launch. The daily price ups and downs won't mean much soon. We will be fools or kings, but at least we acted.
The company most analogous to TTNP on the Nasdaq appears to be BDSI. Now, TTNP's institutional ownership is well below 1%. BDSI is over 80% (only a $250 million market cap). Set aside everything I mentioned above, the appearance of institutions will do wonders for this stock...can you imagine 14-15 million shares being bought up by the funds?
http://www.nasdaq.com/symbol/bdsi/institutional-holdings
Nice article...wish there were more!
Favorite quote: "A 2011 study found patients on medication-assisted therapy (MAT) who were not compliant were 10 times more likely to relapse. Twenty percent of the participants in the study stopped taking buprenorphine and relapsed within three months. The logic behind Probuphine is thus to make compliance as high as possible, and what better way is there to accomplish such a feat than to bypass human volition?"
https://www.thefix.com/will-buprenorphine-implant-drive-patient-compliance
That's a tough one, because to compare apples to apples you would have to survey all second time submissions where an Ad Comm approved the drug the first time around (there are many second time submissions where the Ad Comm didn't approve (or there was not any Ad Comm).
I found this in my research, which appears to show an 88% chance of approval if the Ad Comm votes positively.
However, I learned in the 2013 that the 12% chance of not being approved is, although statistically unlikely, very, very real.
http://www.mckinsey.com/~/media/mckinsey/dotcom/client_service/public%20sector/regulatory%20excellence/fda_advisory_committee_outcomes.ashx
No, in terms of efficacy the numbers are what they are, so I don't expect any surprise there.
I think as a rule the FDA's notes tend to be negative...they are pointing out potential problem areas for two reasons: to genuinely have the committee consider those problems, and to cover their posteriors should there ever be a problem down the road.
Last time, the FDA criticized dosing, etc., but this time they were involved in trial design in response to the CRL, so I don't think they will go there.
More likely their focus will be on this (from the PR announcing results): "...the implant insertion and removal procedures were generally well tolerated; 23% of Probuphine treated subjects and 13.5% of subjects in the sublingual buprenorphine/naloxone group had an implant site adverse event, the majority of which were assessed by the clinical investigators as “mild” in severity."
In other words, is the procedure safe, and does the REMS cover the risks.
I think it's a really good sign if they ask the committee to consider whether a post-marketing Phase IV is required...the Phase IV would be on Braeburn's dime and you don't get to Phase IV unless your NDA is approved.
Price is puzzling, but I guess no one wants to hold this thing prior to the Ad Com. So, we will either look like geniuses or idiots.
Short interest keeps rising. I get not wanting to hold stock before an Ad Com, but being short before an Ad Com is crazy. What if they vote 14-0 to approve...
http://www.nasdaq.com/symbol/ttnp/short-interest
Who knows. I've seen some people say it will never break $10 and others say it will be over $100. It's really anyone's guess.
$300 million in sales would equal about $52.5 million in royalty income, based on a 17.5% royalty initial royalty rate. (According to their 10-Q, Titan is entitled to "tiered royalty in the mid-teens to low twenties on all net sales of Probuphine").
They burn about $8 million in cash now, and given their plans to conduct Phase I/II trials for Pro Neura for ropinrole and the proclivity of management to add barnacles whenever cash is available, I expect that to at least double if they have a steady revenue stream, so let's say they will be spending about $16 million a year.
That leaves $36.5 million in profit. There are 20 some million shares outstanding, so an EPS in the ballpark of $1.82.
What's a reasonable PE for a stock like that? I really don't know. A lot of the "hot" development biotechs have PE's well over 100, but there are plenty of biotechs that are cash cows that have PE's under 10.
So the question is whether Titan gets the myopic eye of the market to focus on it and get "hot." It could happen, especially with the increased public awareness of the addiction epidemic. And there could be other contributing factors, such as ropinrole, a ROW marketing deal or a Phase IV for chronic pain.
Just as likely, however, management completely fumbles the ball. But even in that case, a valuation of $20 a share is low ball, which is why I'm invested. The most critical thing...FDA approval...is out of Titan's management's hands, which is a good thing.
Amen.
The last preclinical testing occurred over a year ago. But from Roth Capital on December 4th.."a pre-IND package for Ropinirole for the treatment of Parkinson’s disease is close to being complete, and there may or may not be a pre-IND meeting with the FDA."
http://biotuesdays.com/2015/12/04/roth-ups-titan-pharma-price-target-to-7-25/
So maybe people are finally waking up?
http://philadelphia.cbslocal.com/2015/12/17/fda-closer-to-decision-on-approving-implant-treatment-for-drug-addiction/
It depends on what you mean by "institutional ownership." If you are talking about mutual funds or ETF's, then according to Yahoo there is very little. Yahoo lists the major institutional holders as of September 30 as:
Gagnon Securities, LLC 61,004
Huntington National Bank 2,850
Estabrook Capital Management 182
In Titan's proxy, they list the 5% holders as being:
Braeburn 1,754,546 (split adjusted)
Broadfin Capital 1,158,637 (split adjusted)
Robert Mead 1,254,756 (split adjusted).
Without my coffee yet, I think that comes to 4,167,939 shares, or about 20% of the 20,059,820 outstanding as of the date of the last 10-Q.
The mutual funds and ETF's are all on the sidelines pending the NDA decision. Sure, they could make a lot more by buying now if the NDA is approved, but they are playing with other people's money and that kind of gamble is a quick way for a portfolio manager to lose his or her job.
If approval occurs, we are going to see a huge change. Check out the holdings of the iShares Nasdaq Biotech Index Fund. Even the companies with the smallest market cap that are held by that fund have mutual fund/institutional ownership around 50%, and some as much as 75%.
So if 50-60% of Titan's shares get bought by institutions, and another 20% are held by major holders, that leaves only 20-30% of the shares outstanding to fill the demand of the street side. We could see a price per share not supportable on an economic basis simply as a result of large interest in the stock and a small number of shares available for sale...at least I hope so!
I don't think that's a big deal. The whole point of a shelf registration statement is that it remains effective for the company to use whenever it sees fit. My guess is you won't see any capital raising PIPE deals until the FDA acts to approve the NDA.
These are new options issued under the new employee incentive plan. Although they haven't been exercised (and no stock issued), the SEC requires you to mark "A" for acquired...because technically they "acquired" the option.
You only have to report option issuances to directors and executive officers. For whatever reason, TTNP takes the position that Beebe is not an "executive officer" for reporting purposes...that's why she's not on the summary comp. table in the proxy. So I'm sure she got options, but there is not any reporting obligation.
Agreed. After my initial reaction, I realized that the bottom line is the FDA is going to either approve probuphine or not. The Ad Comm can only add publicity to the drug, which is good for Titan's stock price. If probuphine is approved, the PPS could be higher because of the added exposure provided by the Ad Comm. If another CRL is issued, then I'm in the same place I would have been if a CRL was issued without an Ad Comm.
The optimist in me thinks the Ad Comm provides the FDA with a way of showcasing how they are responding to the need for innovation in MAT. I can't see why they wouldn't want to approve this drug, but I didn't see it last time either!
The only thing I'm certain about is that I'm uncertain. I agree that because the FDA basically spoon fed the trial design to Braeburn, it seems strange that the FDA now needs an Ad Comm to provide them with advice on how to proceed.
But the FDA makes the rules, changes the rules, and then changes them back...and there is really nothing anyone can do about it. I remember on the conference call announcing the Phase III results the Braeburn representative stated how "grateful" they were to the FDA for guidance. I'm sure she had to stiffle a gag reflex when saying that.
If I had to bet, I'd say the Ad Comm won't have much to do with efficacy or dosage. Rather, they will focus on REMS (specifically, whether Braeburn's training protocol is well-designed) and the Human Factors study, which wasn't a part of any prior Phase III.
I think probuphine will pass muster and get an approval recomendation, but there are a number of well-educated pinheads on each Ad Comm so that I also believe one or two of them will find some arcane reason to vote no on the REMS and Human Factors testing results. Hopefully, with Dr. Young leading the charge and the momentum created by the need to find solutions to the opiate abuse epidemic, Braeburn will be able to carry the day with the FDA (who, as we all know, can ignore anything the Ad Comm does).
Thank god Braeburn is in charge!
Although considering the 5-4 REMS vote last time, maybe they are looking for closure on that issue.
Who knows...useless to speculate.
It should provide a nice run up in December as the Ad Comm date nears.
The FDA makes no sense...positive results in a Phase III designed after meetings and guidance from the FDA...and they need an Ad Com. We won't know how the FDA is disposed towards probuphine this time around until the meeting materials are released.
Adcom January 12th...the Doctor was wrong on this one.
https://s3.amazonaws.com/public-inspection.federalregister.gov/2015-30970.pdf
Roth Capital raised target to $7.25
http://biotuesdays.com/2015/12/04/roth-ups-titan-pharma-price-target-to-7-25/
Time for the weekly reading of tea leaves: According the FDA’s CDER Desk Manual, in a priority review of an NDA the decision for an advisory committee must be made by the end of month 3, which was November 2015 in the case of probuphine. The FDA announced earlier this week that the Psychopharmacologic Drugs Advisory Committee will meet on February 3, 2016, and probuphine is not on the agenda.
http://www.fda.gov/AdvisoryCommittees/Calendar/ucm475312.htm
Given the PDUFA Date for probuphine is February 27, 2016, it would be very surprising to me if the FDA calls another Ad Com hearing for probuphine (which would mean two Ad Coms in the same month).
Short-term, this is bad, because TTNP would probably trade-up to the Ad Com meeting, and the meeting itself would bring attention to probuphine (and Titan). But in terms of approval of probuphine, I think it’s a very good sign. According to the CDER Desk Manual, Advisory committees are typically used when: 1. The application is a new molecular entity, 2. The clinical trial design used novel clinical or surrogate endpoints, 3. There are significant issues regarding safety and/or effectiveness of the drug or biologic, or 4. The application raises significant public health questions regarding the role of the drug or biologic in the treatment or prevention of a disease.
In 2013, the Advisory Committee hearing occurred because, despite evidence of efficacy, the FDA felt there were issues regarding effectiveness and safety. In 2016, the FDA seems to be saying, by not calling an Ad Com, that those issues have been addressed. If there were significant issues I think an Ad Com would be a no brainer, because the FDA would want to publicly highlight those issues to shield itself from criticism for not approving probuphine in the current environment (HHS revising buprenorphine treatment guidelines, opiate abuse epidemic, etc.)
Agreed...I don't know if its arrogance, ignorance or just plain sneakiness, but I don't trust Rubin or Sunil. They have kicked the Parkinson's Phase I date back three years over time...and never once admitted that they actually did so. A little frankness and honesty would go a long way.
S-3
The filing of the S-3 irritated me a bit (who likes dilution), but on reflection I see it as a net positive. My thoughts:
-Under the Nasdaq 20% Rule, they can't issue more than 20% of the capitalization of the company without seeking shareholder approval. So the maximum issuance we are talking about is 4 million shares or so.
-Their balance sheet still looks bad. In order to draw the attention of institutional investors, they need to show cash on hand that will get them through the next 2-3 years (including expenses for Pro Neura for Parkinsons and thyroid deficiency).
-They won't issue shares until we know, positive or negative, about probuphine approval. To do it now would only put them at risk of a million shareholder suits if probuphine isn't approved. Institutional investors will probably want to wait a few weeks afterward to let the "approval spike" turn downward (assuming probuphine is approved).
-With 20-30 million in cash, TTNP becomes a different investment. Institutional ownership will be around 50% of the outstanding, and Braeburn and other major holders will still hold around 10-12% after a capital raising offering, leaving only around 40% of the shares for the street.
Whatever
I'm starting to check this stock way too much, which ain't good. Time to embrace the suck.
Probuphine will either be approved or not. If not, I'm screwed, but whatever, I took the risk. If its approved, then I believe things will be good.
The approval itself should shoot the price up over $10. I don't think anything else will move the price until then, unless we happen to get an Adcom that creates some buzz.
I expect the price to go down sharply following the post-approval peak: too many people will either want to take profits, or get discouraged the peak wasn't high enough and bail.
And then things will really get interesting. I took a look at the "bottom ten" of the 145 issuers held by iShares Nasdaq Biotechnology ETF (Titan isn't one of them). So, these are the ten smallest holdings of the fund, all of which have market caps in the $50 to $200 million range.
All of them appear to have institutional ownership between 25 and 50% (September and August numbers). So, I expect in the 2-3 months following approval, 25 to 50% of the float will be bought up by institutions (remember, around 15% of the outstanding is owned by Braeburn, Broadfin and some dude I can't remember his name).
So the availability of shares will be reduced, press on probuphine should pick up and I think TTNP breaks $20 before the end of the Summer..at which point TTNP will probably do a secondary offering for cash (say 2 million shares at $12.50) and we end up 2016 around $15 or so.
Either that or it will be bankrupt.
Exact Phrase "Braeburn Pharmaceuticals" and last update "past week."
The result comes back as having been updated 4 days ago. That may very well be the day it was first created/posted.
According to Google Advanced Search, it was within the last week.
Hopefully this is a good sign....
https://braeburnpharmaceuticals.com/pre-registration/
Panel
Since the whole FDA review process is a mystery to me, I've been trying to educate myself. The put out a pretty good power point summary: http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDER/ManualofPoliciesProcedures/UCM218757.pdf
Since this is priority review and we are in Month 3, the FDA is required to decide in November whether a panel will be necessary and then communicate that to Braeburn. So if we haven't heard anything by the first week of December, I assume no panel.
Well, that sucked.
The conference call left me with a “glass half empty” feeling. Nasdaq listing has not brought any new analyst coverage: still just Roth and Zacks, lower level firms without a real wide impact. They are ignorant about Braeburn’s launch plans. Parkinson’s Phase I was pushed back, again, from 2H of 2016 to “late 2016.” And they failed to make the case for me about T-3: there are no real compliance issues that would make an implant a great fit; and on the titration issue I can’t help but think that if 15% of a 15 million user market wasn’t being well served and there was a profitable way to serve it, it would have be done already. My understanding is these are generics…so who is going to pay for a $2,500 implant when you can get the drug for $5 or $10 a month…side effects may be a pain, but I don’t see insurance covering it.
Sunil, Sunil, Sunil…ugh. Kate Beebe should be the only voice of this company, as she is obviously the only one doing any real work. Sunil and Rubin are dead weight, and, in Sunil’s case, his lackadaisical, “what me worry” personality do not inspire confidence.
Personally, I would have been thrilled with a partner a year ago, but now that they are so close to the PDUFA date, I think its probably more prudent to wait until you have an FDA approved drug until you negotiate a license deal because the financial terms will be better. It's not really a "partner" they're looking for but a sales channel.
Hypothyroidism New Pro Neura Platform
15 million potential patients in US market looks promising.
http://finance.yahoo.com/news/titan-pharmaceuticals-adds-proneura-implant-123000014.html
I didn’t read it that way. 31% of the doctors want an opioid agonist/antagonist, with the antagonist (denying the “high”) activated only upon crushing/snorting a pill. Buprenorphine is an opioid agonist, and with Probuphine you don’t need the “antagonist” aspect because its implanted and can’t be crushed/snorted.
22% of the respondents preferred physical barriers (I think probuphine would fit that definition) and 16% called for a novel delivery systems such as an injections or implants…so 38% would seem to fall into Titan’s wheelhouse. And if TTNP could capture 38% of the market (or 16% for that matter), I think we’d all be very happy.
If it were me, I would name the Parkinson's/ropinrole candidate "Prorophine" or something like that...keep the "Pro" prefix with all the drugs in the Pro Neura family.
I'm assuming they will file the Q next Monday morning with a call then too...but to your point, probably not announce the call until Friday. Their first earnings release as a NASDAQ company...a little institutional interest would go a long way right now, particularly in light of the fact they've promised the new product development candidate for Pro Neura will be announced on this call.
They should also name the Parkinson's candidate...gives them a little more credibility. Right now it just sounds like some vague research and development project.
Man, that just disgusts me. Probuphine gets a CRL after showing efficacy on trial endponts agreed to with the FDA in advance. Oh sure, priority review which means the FDA's "goal," if they get around to it, is the respond by February 27th. But the Camurus depot formulation gets "fast track" status. Are they accountable to no one?
I'm not a big fan of Sunil or Rubin for that matter, but I'm not really surprised on the lack of press. I'm not sure, but I've always assumed that the custom was not to have a lot of public articles regarding a drug while the CDER was in the process of reviewing it. Kind of like the "quiet period" companies do immediately prior to an initial public offering.
Depends on how long you plan to hold. If your horizon is the next few months (completely understandable, as the FDA is the "Queen of Hearts" changing the rules as it goes, so many refuse to hold in the weeks prior to a PDUFA date) then I don't think you'll see $8.00. Post approval, yes, I think we make $15 in the first 12 months, or even higher depending on the sales, chronic pain supplemental indication, and ROW marketing deal.
I think the odds are against an earlier than scheduled approval. The Manhattan Institute did a "FDA Report Card" and the CDER Division to which the probuphine application was assigned...Division of Anesthesia, Analgesia, and Addiction Products (DAAAP)...got generally low grades in terms of response time. They take longer that some of the divisions that have granted earlier than scheduled approval...such as the division in charge of cancer.