I think they are down to 3 million after last month...so onward and upward!

This month we might just drift a bit. There will be a bunch of press releases about training issued by Braeburn, but I don't see much else happening news-wise unless Braeburn releases some hard data on sales.

According to Braeburn's Jefferies presentation, Medicaid coverage should begin on the 15th of July, so maybe they will PR that.

You would think that since Titan is asking for a boat load more of options for their incentive plan, they would be issuing some PR's with good news in advance of the stockholder meeting...but if you want to make God laugh have an expectation on this stock!

Don't forget the warrants, which is not Braeburn. There were over 1 million exercised in June, and probably immediately resold under the shelf registration statement. Could be a lot of things.

Hey Turks,

While I'd be thrilled to hear some great news, I think the reason they want options is to grant them to themselves, plain and simple.

While they may need additional employees sometime in the future, the most they have planned this year is a Phase I for Parkinsons which will be outsourced to a testing organization. I'm actually not confident that they will even get that done in the next 12 months, as they have delayed for over four years on it.

I don't really see the need for a VP of Business Development. All the pharmaceutical companies are aware of probuphine, and Licensors will approach them, not vice versa.

And while yes, the progress on probuphine is impressive...that's 99% Braeburn's progress. Titan's real work on it stopped years ago. I'm all for incentives for performance, but where was their performance this year? Take away the winning lottery ticket of probuphine, and all I see is further delays on Pro Neura.

Chances are it will pass however and they will get their options.

Option Plan

So if you recall, last year the stockholders approved an option plan for 7.5 million shares (with 110 million shares outstanding at the time).

It was approved.

After the split, the 7.5 million was adjusted to 1.36 million.

Now, the are asking for 2.5 million, which translates pre-split to 13.75 million.

I'm voting no.

Warrants

On May 10th, TTNP reported 20,084,760 shares outstanding in its 10Q. As of June 27th (the record date for the shareholders meeting), there were 21,198,879 shares outstanding. So, 1,114,119 new shares outstanding.

Must be warrant exercises.

There were 983,395 2013 Series A Warrants with an exercise price of $4.65 per share, and 2,863,643 2014 Series A Warrants with an exercise price of $3.30 per share.

Dilution is never fun, but it was going to happen no matter what, so at least that little bit of it is over. Plus TTNP will have an extra $3.6 to $5.1 million in income for the quarter.

We might see a few more of these. These firms are really the lowest of the low.

http://www.andrewsspringer.com/cases-investigations/TTNP/

...and there is no law preventing them from shorting the stock before the announcement, as it is not "material nonpublic information" regarding Titan, only the announcement of an "investigation." Nice way to pick up a few bucks if the legal fees aren't covering the rent.

Ah, the class action plaintiff's securities lawyers. Ignore this, it's just how the game is played.

In the proxy statement filed yesterday, Titan's board is recommending the adoption of amendments to their stock option plan, increasing the number of shares that may be granted and increasing the limit of the number of shares that might be granted to any one person.

There is nothing legally wrong with that (although as a business matter, people might disagree about whether Titan's management has done anything to earn it).

However...there is a chance that if the plan is approved and options are granted, Titan may have material nonpublic information it doesn't release until after the options are granted (e.g., ROW deal, etc.) which might make the exercise price of the options lower than it would be if that information was disclosed.

If that were to happen, everybody in the world would sue Titan. Seriously, about 100 plaintiffs firms would file lawsuits (they literally just cut and paste the complaint somebody else filed).

There would then be a settlement. And attorneys would have to prove how much they had worked on the case to justify legal fees. So by stating they are "investigating," these pigs are just reserving their place in line in the event (highly unlikely, in my opinion) there is a lawsuit.

Examples:

http://www.prnewswire.com/search-results/news/Possible%2520Breaches%2520of%2520Fiduciary%2520Duty-30-days-page-1-pagesize-25

No argument here.

They could get them the day after the stockholder meeting, priced at less than $2 a share pre-split. A lot for the stockholders to give up when most of their "progress" over the last few years has actually been Braeburn's efforts on probuphine.




Great delivery system, questionable management.

I don't see anyone in the current management team deserving over 90,000 a year in options, so I'm inclined to vote no as well.

But if they had to issue a new first class CEO 500,000 options to take the job, I'd be for it.

New Proxy Filed...Gotta love Proposal #2

On June 17, 2016, the Board adopted, subject to the receipt of stockholder approval, the Amendments to the 2015 Plan to (i) increase the number of shares of common stock reserved for awards from 1,363,637 to 2,500,000 and (ii) increase the maximum number of shares that may be granted to any one person in a calendar year from 90,909 to 500,000.

ROW

So what's everyone's opinion about where in the world (outside the US and Canada) is the low-hanging fruit that Titan should focus it's efforts to license probuphine?

I have been centered on the EU, but after a little research it appears that Titan can't get a "EU" approval for probuphine, and will have to go country by country. The two most likely suspects in my mind are France (buprenorphine usage from the 1990's on) and England.

I think the best bet early on might not be in Europe, but Australia. Population of 28.8 million, with prescription drug addiction affecting 864,000 to 1,152,000 of the population.

The Australian Medical Association has recently declared prescription drug addiction a “national emergency,” as Australia is currently in the same situation as America in regards to unprecedented harms being caused by the abuse of prescription medications. Australia’s rate of prescription drug addiction was reported as second highest in the world last year, only after the United States, and afflicts 3-4% of the population.

http://www.thecabinsydney.com.au/prescription-drug-addiction-in-australia-is-out-of-control/

Oops...I see training is actually occurring next weekend and not over the 4th. 1,388 people have been trained in the first four weeks.

Orlando, Albany, Charleston, Grand Rapids, Atlanta, New Orleans and San Antonio are the locales for this Weekend's Training

On a holiday weekend no less!

http://www.prnewswire.com/search-results/news/Braeburn%2520Pharmaceuticals-30-days-page-1-pagesize-25

Gingrich, Kennedy and Jones: Treat America’s Opioid Epidemic With Medication

Nice probuphine mention in a Time Magazine editorial.

http://time.com/4384781/advocates-for-opioid-recovery/

Over 50% would be my guess!

Over 1.8 million short as of 6-15, and I assume it's only grown since then.

Last June, as we awaited the Phase III results, for me to be right I needed to Phase III to show efficacy. It did, and then some. Then after the Ad Comm, when we slipped down to below $3.00 per share (after having been at over $5 following filing the NDA), for me to be right, the FDA had to approve the drug despite some very loud and vocal critics (financed by an entire industry). It did. And now, for me to be right, I just need patience and a 5 to 10% market share. Not 50%, not 40% not even 20%. Just 10% and I think we've hit a home run (over $400 million in sales).

What do they (the manipulators, shorters and the like) need to hit a similar home run? What do they need to be right? For the opioid addiction epidemic just to magically disappear. For over 5,000 doctors investing a day of their lives in an 8 hour training session need to say...that was worthless, I'm not going to prescribe it. For patients demanding the drug to change their mind and say...eh, I'd rather risk relapsing.

Patiently holding and looking forward to the day when a lot of talking heads have "discovered" this hot new stock called Titan Pharmaceuticals.

That's really weird.

Maybe someone negotiated a deal with an institutional buyer and exercised their warrants to fill the order (Broad Fin or Braeburn)?

Female Opioid Addiction Focus of New Task Force

http://www.washingtontimes.com/news/2016/jun/23/female-opioid-addiction-focus-of-new-task-force/

May the FORCE be with you?

It's a nonprofit funded by Braeburn.

http://www.prnewswire.com/news-releases/new-force-to-address-opioid-addiction-epidemic-launches-efforts-with-awards-recognizing-prominent-women-leaders-300289404.html

Female Opioid addiction Research and Clinical Experts (FORCE)

A press conference today at the National Press Club. Behshad Sheldon is a member. Another positive.


http://www.press.org/events/female-opioid-addiction-research-and-clinical-experts

Great post Tip!

Not sure of course, but in terms of the milestones, I remember in 2013 Braeburn reduced the upfront approval payment from $50 million to $15 million in light of the CRL. I think the $35 million was added to the amount of sales milestones to be paid...so I am hoping Titan negotiated for the lost $35 million in approval milestones to get paid relatively quickly upon achieving a relatively low sales milestone...but who knows. I would say you prediction of 1Q 2017 is right on track!

I hope you're right!

A ROW license agreement will be interesting. It's an approved drug now, not a "developmental" stage drug candidate like it was when the Braeburn deal occurred. Titan's ROW partner will not have to invest anything in clinical trials, NDA's, etc., and it is a slam dunk to get approved in other jurisdictions. Basically TTNP is just looking for a sales channel.

Less risk and expense translates to a much higher royalty percentage for Titan. 33% at the low end, and 50% at the upper end.

So every ROW sale at a 50% royalty is as profitable to Titan as 3 US sales at a 17% royalty.

The royalty is paid on net sales. Basically, the sales price $4,950 less any rebates, returns, etc. The doctor charges extra ($100 to $400) for the procedure.

So last week with 10 implants Braeburn made $49,500, and Titan will receive a royalty around $8,400. The first income from sales I can remember!

With the first commercial sale, last week also began the "Royalty Year" for purposes of the license agreement. We now have to think in terms of both the fiscal year and royalty year. Sales milestones are paid in terms of the first time sales reach a certain dollar level in a royalty year. We don't know what the milestone levels are, but I would guess $50 million would be the first milestone "cliff," and we have until June 2017 to achieve it.

Just a WAG, but they trained 1,100 doctors in the previous 12 training sessions (averaging about 90 per session). With 7 more this weekend at the same average, we would have another 630 trained (over 1700 total).

TRAINING

They are kicking it up to the next level...7 cities this week instead of 3 or 4. Columbus OH, Manchester NH, Philadelphia PA, Minneapolis MN, St. Louis MO, Portland OR and Los Angeles CA.

http://www.prnewswire.com/search-results/news/Braeburn-30-days-page-1-pagesize-25

Interesting. The real battle ahead lies not with insurers, medicaid or even sublingual competition, but between those who advocate medication assisted treatment and the purist who advocate total abstinence.

One would think the inability of abstinence based recovery programs to stem the tide of the addiction epidemic would give them pause before criticizing MAT, but apparently not...

Yes, it won't happen overnight.

I'm going to be really interested in November to see the 3Q sales numbers in the 10Q...it should give us an idea of how things are selling.

Between now and November, a ROW licensing deal would be welcome. As well as an update on Braeburn's progress with the FDA on Phase III trials for chronic pain.

You're numbers are correct, and it is crazy given TTNP's current price. I think Turks has it right when he says the market has to "figure Titan out." I don't think many people understand what is going on.

The numbers get really crazy when you factor in that under the REMS, a health care provider has to prescribe probuphine to 10 patients a year in order to stay certified and not have to re-take the REMS training.

Let's say only half of the 5,000 trained doctors prescribe at that level in 2017 for a total of 25,000 patients (6% market share of 412,500 patients stabilized at 8mg or less of buprenorphine).

2,500 x $4,950 x 10 x 2 = $247,500,000.

20% royalty= $49.4 million

Operating Expenses ($12.0 million)

Profit $37.4 million

EPS: $1.87

Average PE in Pharma: 32

PPS: $59.84

Braeburn has also increased the # of health care providers it plans to train in 2016 from 4,000 to 5,000.

"We recognize the importance to both physicians and patients of this new treatment for opioid dependence and are working to train 5,000 healthcare providers before the end of the year.

I think the average PE ratio in pharma is around 32. I tend to think Titan would at least make the average, because the future revenue from probuphine for chronic pain, parkinsons and T3 make it a growth play.

Sales Occurring!

"In the three weeks since we received FDA approval for Probuphine, we have trained over 800 Healthcare Providers who have already begun treating their patients with Probuphine"

http://finance.yahoo.com/news/probuphine-buprenorphine-implant-phase-3-133000894.html

...because from patient share we can come to sales estimates.

From the Braeburn presentation: 825,000 current buprenorphine users. At the Ad Com, they said 50% had been stabilized on 8mg or less.

So the addressable patient population is 412,500 patients. Assuming two treatments per year @ $4,950, the market share, patient # and corresponding sales are:

Share Patients Sales
1% 4,125 $40,837,500
2% 8,250 $81,675,000
3% 12,375 $122,512,500
4% 16,500 $163,350,000
5% 20,625 $204,187,500
6% 24,750 $245,025,000
7% 28,875 $285,862,500
8% 33,000 $326,700,000
9% 37,125 $367,537,500
10% 41,250 $408,375,000
11% 45,375 $449,212,500
12% 49,500 $490,050,000
13% 53,625 $530,887,500
14% 57,750 $571,725,000
15% 61,875 $612,562,500

Oops. I knew there was something weird about them publishing that 15.7% patient share projection...when they had never talked numbers before. Somebody caught it, but luckily not in time for us (thanks Truth!).

Nice find Truth, thank you for posting. If we have insurance companies on our side, then things should really get interesting.

All in my opinion:

Throughout 2015 and 2016 Titan stated that they were meeting with regulatory experts in the EU to determine the best path forward to obtain approval of probuphine. It was maddening to hear that nothing had progressed each conference call, but I don't blame them for stalling. Given their cash position, spending money on European approval in the absence of a US approval doesn't make sense. If they could have just been honest about that, it would have built trust with stockholders. Now, I question anything they say about a ROW deal. That being said, in the last conference call, Kate Beebe stated that following probuphine's approval they have been approached by third parties to commence due diligence for an out-licensing deal. This is in contrast to their previous "go-it-alone" approach, but I think its a positive development. I hope Titan will act with a sense of urgency, but they have kicked the can down the road so many times I can't say I have confidence in that.

In terms of Pro Neura, I am sickened by the lack of progress. Again, it could be explained by a lack of funds, but they were never honest about that. See how they describe themselves as "on track" as the goal posts are continually moved just over the last year:

May 2015

And now to provide you with an update on our ProNeura for Parkinson’s program, which we’re very excited about. Our goal is to complete all the non-clinical work required in support of an IND this year and early 2016 meet with the FDA for a pre-IND meeting possibly late this year. File the IND in the first half of 2016 and be prepared to initiate a clinical proof of concept study in late 2016. We remain on track to meet these goals.

November 2015
Our goal is to initiate a clinical proof of concept study in late 2016, following the approval of Probuphine.

May 2016
In January the FDA provided written feedback on our initial development plan. And based on the FDA’s feedback, we’ve begun the required non-clinical studies to support the submission of an IND application, which is currently targeted for the fourth quarter of 2016 to be followed by the initial pharmacokinetic and proof-of-concept clinical study.


So, the parkinson's Phase I has slipped to 2017 from 2H 2016.

Agreed. It doesn't mean anything. Strange that we seem to go up when Braeburn announces something, but down whenever Titan does, but I've become used to the weirdness. A little red meat in the press release would have been nice..."the first ___ probuphine implant procedures took place last week" etc. I wish there was a way to track actual procedures rather than waiting for quarterly results.

Indy and DC Training This Weekend

http://finance.yahoo.com/news/braeburn-pharmaceuticals-conduct-first-series-120000768.html

http://www.prnewswire.com/news-releases/braeburn-pharmaceuticals-to-conduct-first-series-of-probuphine-buprenorphine-implant-trainings-in-washington-dc-on-june-17-18-and-19-for-qualified-healthcare-providers-300283926.html

Off label

Possibly already occurring.

https://www.aapc.com/memberarea/forums/138182-probuphine-implant.html

Too bad we didn't have to pay Braeburn $15 million, and we would probably have doubled in price! This Alice in Wonderland world of 100% retail and market manipulators has long lost its charm.