Two days up in a row. It's been awhile since that happened...

ROW

Interested to see what the strategy is. Due diligence is being conducted for Europe and "other geographies" (Zack's words). TTNP is taking the lead on meeting with the EMA for Europe, but the "other geographies"elsewhere (Australia, Japan, Hong Kong, Singapore) might move more quickly in terms of an actual deal.

100,000 treatments per annum maximum capacity of rods from the contract manufacturer. If probuphine sells well in the US, then potentially having enough rods to provide a sublicensee could be an issue until Braeburn builds their plant.

Any ideas about what moved the price today? Nothing has changed from the CC, so it was either short covering (unlikely in my opinion) or someone starting/increasing a position. The 13F's just came out showing Blackrock and Vanguard as major holders, so maybe that attracted the attention of some other institutions. At some point, some index funds should be buying TTNP as well (there are at least 10-15 Pharma index funds).

Well, I'm the genius that thought we'd be close to $20 on approval, so I feel your pain.

All they are saying is, at this time, they value Titan at $12 a share. Granted, they are not describing the home run that I would like to see, but frankly given where Titan is at right now I would take it.

Remember that no one punishes an analyst for underestimating how well a company will perform (they just raise their target price), but they can get in big trouble with clients for inflated future projections. There is an institutional bias towards conservatism which is probably appropriate.

Breaking down the numbers, Zacks is calling for $9.4 million in probuphine sales in 2016 which means about 1,900 treatments, $97.3 million in sales in 2017 which means about 19,800 treatments, and $154.8 in sales in 2017 which means about 31,500 treatments.

Today, 2,342 health care providers are certified. So Zacks is estimating only 81% of those currently certified will prescribe a treatment by year end. Obviously conservative, but what is their incentive to speculate higher?

By January 2017, 4,000 health care providers will be certified. So for 2017, Zacks is estimating the average certified provider will prescribe around 4-5 treatments a year. Again, this seems low (especially if a large percentage of patients opt to have a second or third implant).

By 2018, Braeburn's goal is to have 6,000 providers certified. The 31,500 treatments again averages out to around 5 treatments per certified provider.

Even more conservative when you factor in the analysis excludes: sales milestone payments ($165 million potential, but we don't know the trigger points), potential sales of probuphine in Canada, the effect of a probuhpine sNDA for chronic pain, the increased inherent value from initiating Phase I and Phase III Pro Neura trials for ropinirole and T3 and ROW licensing deals for probuphine.

Things aren't as bleak as they seem...

1. Two strong buy recommendations.
2. Enough cash to last through 2017 without a capital raise.
3. Institutional ownership is up to 8.5%, with Vanguard and Blackrock holding the most shares. No ETF funds listed in the institutional ownership table, or funds that use Russell 2000 as a benchmark. Those funds will be buying.
4. 1.9 million shares held short, and they have to cover some time.
5. $12 target from Zacks based on conservative 2-3% probuphine market penetration, and which doesn’t factor in ROW rights, chronic pain, ropinirole or T3.

Analyst report

http://s1.q4cdn.com/460208960/files/News/2016/August-10-2016_TTNP_Vandermosten.pdf

On this week's conference call, Sunil mentioned Braeburn's speciality pharmacy began to be operational for probuphine shipments in late July. So although dozens of patients had been treated as of mid-July according to a Braeburn statement, sales through their chosen sales channel didn't really begin until the end of the month. Hopefully, things will really pick up now.

I was kind of impressed that in the speciality pharmacy's addiction management webpage, probuphine was called out with its own link (suboxone, bunavail and others are thrown together on another link).

https://www.avella.com/specialties/addiction-management/addiction-medications

The supply chain seems to work as follows:

Implants are manufactured by DPT Labs and then sent Avella for storage.

Healthcare providers order from Braeburn, who forward the order to Avella, who fills the order by overnight delivery.

That being said....Blackrock and Vanguard have taken fairly large stakes as of 6/30. Hopefully just the first in many to follow.

http://www.nasdaq.com/symbol/ttnp/institutional-holdings

I don't think the majority of the shorts will cover until they have to...so far the market has agreed with their conclusion that Titan is overvalued.
We need an event or earnings to attract institutional interest and force the shorts to cover.

For what it's worth, Zacks came out with a report yesterday reconfirming their $12 a share valuation. That valuation excludes the effect of any ROW deals.

It's Zack's belief that Titan won't raise money through an offering for the next 1 to 2 years, so dilution doesn't seem to be a concern. Titan also avoided 1 million shares of dilution by allowing a cashless exercise of 2 million warrants, which is a positive I think they should have mentioned on the conference call.

It's just conjecture on my part, but I think today some people just got sick of it all and bailed.

For myself, I was so tied up with probuphine approval, that since it occurred I have been completely baffled at the collapse of the stock price. We are at 88 cents pre-split: less than the exercise price of Braeburn's warrants. It doesn't make sense, and when something doesn't make sense for a prolonged period of time people want to move on to something that does. Completely understandable.

There was nothing in the call that screamed sell (it was positive in my opinion), but it looks like the can has been kicked down the road some in terms of ever rising above present price levels. I need to sell some shares to pay for some life events in the next few months, and I'm debating whether to hold through 3Q in hopes that significant royalty revenue will bring new buyers and a 20-30% increase from current levels. But I have to admit, I fear that it's equally as likely that we are at $3.50 a share by then. I really thought $5.00 was an absolute floor for this thing.

Logic tells me hold...but when has logic ever held true with Titan's stock price?

Nice post. There is obviously a lot of resistance on Titan's part about making any forward looking projections because they simply don't know.

That being said, the analysts are grasping for anything they can, and there is not much to hang your hat on other than it's an approved drug with a novel delivery system, there's a lot of public interest, and a lot of health care providers have been trained and certified. Everything points to a positive future, but it could flop.

In his last report, Vandermosten of Zacks projected $7.7 of sales in the second half of 2016, with a royalty to Titan of $1.2 million. That translates to about 1,555 patients receiving a full four rod treatment, for an average of about 259 patients per month. But that's just a guess on his part.

Quite a drop today on very little volume...

Short interest is down, but not much: http://www.nasdaq.com/symbol/ttnp/short-interest

Who knows! I don't understand the current price, or over 2 million shares being held short. Unfortunately, I need to sell about 20% of my holdings for some family medical expenses. I was hoping for a little pop after the ER so I wouldn't have to sell as many shares, but that's life.

Agreed. Any information is better than none at all. The EMA meeting is progress, but I am still a bit confused because I thought an EU wide approval was not possible under the regulations because buprenorphine was already approved in Europe, and that probuphine would need to be approved on a country-by-country basis. I guess we will see. That being said, it's curious to me that Titan would take on the drug approval process in Europe with so much else going on (Parkinsons, T3). It would seem to make more sense to focus efforts on a license, and let the licensee deal with approval (like Braeburn did in the US).

It was left open whether the pharmaceutical companies doing due diligence are for Europe or elsewhere. Interesting.

On reflection, I think the "cashless exercise" of the 2 million warrants into 1 million shares (rather than 2 million shares in return for the cash exercise price) is a positive. The money from the warrants would have pumped up earnings this quarter, but Titan seems to be thinking that it's better to prevent dilution at these price levels than to receive the proceeds. It has the same exact effect as a buyback of 1 million shares, and should be seen as a positive in my opinion.

I don't think so...I've never really understood that receivable line entry, but I'm no accountant. It was 4.2 million as of year end, but I'm not sure what the heck they're talking about.

Looks like we have another quarter to wait until any significant price movement. I'm happy to be wrong on that one...(provided its movement upwards!)

The additional share mystery is solved. The cashless exercise prevented a little over a million shares of dilution, but no proceeds of exercise went to Titan.

In May and June 2016, 1,072,307 shares of common stock were issued upon the cashless net exercise of 2,016,075 Class A Warrants in accordance with their terms. There were 847,569 Class A Warrants outstanding at June 30, 2016.

In May and June 2016, 58,569 shares of common stock were issued upon the cashless net exercise of 114,546 Underwriter Warrants in accordance with their terms. There were no remaining Underwriter Warrants outstanding at June 30, 2016.

I hear you, but I'm just out of patience for this routine.

Not filing the 10-Q in a manner that would allow analysts to review it prior to the earnings call is either transparently manipulative or utterly unprofessional.

I now think the shares outstanding number in the proxy was a typo, but I really have no idea what is going on there.

Braeburn announced 10 rods were implanted in June. Maybe they gave them away for free? Otherwise, Titan should get a royalty.

There won't be anything in the call about ROW other than "we are continuing to discuss with regulatory experts..."

I have to be honest, I'm disappointed by the release. Initial thoughts:

1. Where is the 10-Q? Why isn't it filed at the same time?
2. No explanation of why the outstanding share number went up by 1,114,119 between early May and late June. Apparently not warrant exercises (or else they would have disclosed the proceeds). So just what is going on? Employee option exercises?
3. No royalties for 2Q despite the fact that rods were implanted. Why?
4. No mention of ROW out-licensing efforts.
5. No disclosure of the number of rods sold in 2Q.

The CC is at 4:15 eastern tomorrow, so I'm assuming the ER will come out premarket?

Thanks for the reminder. I hadn't thought of that...many of those undergoing training may have maxed out prescriptions under the current law. August could see a big uptick.

Earnings Predictions for 2Q?

My guess is $0.84 per share.

As of the end of June (proxy filing), there were 21,198,879 shares outstanding. As of the 1Q 10Q (May), there were 20,084,760 shares outstanding. The increase is not option exercises by management. My guess is the holder of the 983,395 of Class A Warrants exercised (and sold) right after approval. The exercise price was $4.89 per share, so $4.89 x 983,395 = $4,808,801.

So earnings should be:

Milestone Payment-$15,000,000
Warrant Proceeds-$4,808,801
Expenses-($2,000,000)
Net-$17,908,801

$17,908,801/21,198,879 = $0.84

I've done a little thinking about why that hasn't happened already. After all, billions are spent by big pharma trying to develop new drugs each year with a very small success percentage, and here is a proven, FDA approved delivery platform on a silver platter they could get for a fraction of their annual R&D budget.

But Pro Neura has only been used, thusfar, with generics...buprenorphine, ropinirole, etc. And BP has a bias in favor of patented, branded drugs, especially pills (the FDA is a reflection of that bias). Actual therapeutic compounds rather than delivery mechanisms. Like all biases, it's not logical, because money from Pro Neura spends just as well as money from the next big pill.

If Titan ever starts to work with big pharma's on co-developing patented drugs using Pro Neura's delivery system, then perhaps they will catch on and Titan will be purchased by a big pharma both to develop Pro Neura for their own drugs and to prevent Titan from partnering with third party competitors.

In the Braeburn license, they have milestones payable upon the filing of an NDA (actually sNDA) and approval of an NDA (sNDA) for new applications of probuphine. It's all in Braeburn's control.

My guess is the largest milestone money wise is probably chronic pain. Because buprenorphine has already been approved for chronic pain, Braeburn could use 505(b)(2) and probably do a single Phase III to support a sNDA. Braeburn's presentation calls for probuphine for chronic pain being launched in late 2018.

Not sure what the other indications would be for...perhaps depression in connection with suicidal thoughts or even veterinary usages for pain.

Opioid-related insurance claims rose more than 3,000 percent 2007 to 2014

http://www.cnbc.com/2016/08/01/opioid-related-insurance-claims-rose-more-than-3000-percent-2007-to-2014.html

8-K was filed...option plan passed.

Happy dilution day!

DPT Labs in San Antonio Texas.

http://www.dptlabs.com/

In the call, they said capacity to make 100,000 treatments (400,000 rods) per year.

It makes total sense, and I actually thought it might have happened by now. I guess they (Braeburn) are focused on the launch and waiting to see how successful it is in the market. Apple Tree probably wants to see some profits before they are willing to fund an acquisition.

Personally, I think its a dumb call to wait. They could have all of parkinsons (approved by 2019 with no phase II required and "1 or 2" phase III's) and T3 (probably approved by 2020) for nothing.

$10 a share would get well over 90% stockholder approval today. But after a few quarters of royalties (and maybe a milestone payment), chronic pain Phase III's being initiated and Parkinsons Phase I results (which is where we should be in a year), the price will be at least $20 or possibly more.

Listen to me babble...it could be at $4.00 for all I know.

Yeah, get that WiFi fixed will you!

Obviously, the market doesn't see what we do. It's not for a lack of publicity or awareness. And perhaps that's why we haven't seen a ROW deal yet. Maybe no potential ROW partner can see the value in the implant.

I would love to see this thing run, but to have gone through the last year and be at 0.90 a share pre-split is certainly not how I thought things would work out. I really question the move to Nasdaq. What did it really accomplish?

Our CEO says "the stock market is going to do what the stock market is going to do." That's not good enough for me, and I'm looking for reasons why. Market reasons: Braeburn cashing out, over 1 million warrants exercised and sold, BroadFin cashing out, over 2 million shorts. Business reasons: "wait and see" attitude on probuphine sales, no confidence on management's ability to execute on parkinsons and T3, success of probuphine is tied to Braeburn, not Titan.

...from your keyboard to God's ears!

It was at noon Eastern. Probably over by now.

No. They will 8-K the results of the votes, but there won't be any new information coming out of it. We have to wait for the earnings call mid-month.

ROW

They really need to engage a sales agent to find and structure a deal for them. It's abundantly clear they cannot do it themselves.

Yeah, that occurred to me but I went to worse case scenario. Maybe I'll just email Braeburn and ask!

Talking this over with a friend last night, I can't imagine Sunil making the "one maybe two" Phase IIIs statement without having had the benefit of discussing with the FDA (they met in January to discuss ropinrole for Parkinsons).

So a timeline would be:

1. IND filed in 4Q 2016
2. 6 month Phase I/II commenced in late 4Q 2016.
3. Top line data released from Phase I/II in late 2Q 2017.
4. Meet with FDA to discuss Phase III trials in 3Q 2017.
5. Phase III's commence in 4Q 2017.
6. Top line date from Phase III's in 4Q 2018.
7. File NDA in 1Q 2019.
8. With standard review, FDA decision in 4Q 2019.
9. Launch in 1Q 2020.

With priority review, you could move that up 3 months or so. Or if the Gods smile upon us and we get accelerated approval, then move it up 6 months or so.

Prescriptions

“To date, over 1,800 healthcare practitioners have been certified — 27 have implanted dozens of patients, according to a representative for Braeburn Pharmaceuticals, Probuphine's maker.”

http://www.npr.org/sections/health-shots/2016/07/28/487080738/doctors-need-a-new-skill-set-for-this-opioid-abuse-treatment

According to Braeburn's press releases, the 1,800 certified number would have been as of July 17th (another 700 or so have been certified by now).

The terms "dozens" is deliberately vague. It is at least two dozen (24), but in all likelihood less than 100, or else they would have said "over a hundred." I'd guess around 40-50 as of the 17th, and that the full month's number (July) will be in excess of 100.

Zacks is predicting about 400 prescriptions in 2016, with a huge ramp up in 2017. I think Titan (I mean Braeburn) will beat that estimate handily.

That's a nice find, thanks for posting!

Key takeaways for me were:

1. They plan on not just filing the IND, but commencing the Phase I in 2016 for ropinirole (parkinsons).

2. Both ropinirole and T3 will involve a Phase I and then go straight to "one maybe two" (Sunil's words) Phase III's. So it's conceivable that Titan could have Parkinsons in Phase III trials by the end of 2017, with an NDA being filed (and approved if priority review is obtained) in 2019. T3 in 2020.

Just my speculation, but assuming probuphine royalties are available to fund operations, I would expect them to keep both Parkinsons and T3 "in house" through the Phase III's and not outlicense them. This will allow them to partner with a sales channel and get a much higher royalty if approved. Other development efforts (new compounds from BP) will most likely be in partnerships, where TTNP gets a smaller royalty percentage but is paid all of its development expenses.

I think under the original sublicense to Novartis, once the patent expires the royalty becomes fully paid up. Not really sure...

"Titan" comes from Greek mythology...immortals that lived before man. The most famous Titan is Prometheus, who gave the gift of fire to men, and was punished by being chained to a rock for eternity where his liver was eaten daily by an eagle, only to be regenerated by night, to repeat the same thing the next day.

Kind of reminds me of owning this stock....

I think they (Braeburn) will be monitoring it, and then go for a post-approval labeling change. No Phase IV was mentioned in the approval PR, but I think that is what is planned.

Chronic pain, parkinsons and T3 all depend on more than just one year of implants.