Cassava Sciences Inc (SAVA) 2013 Q4 法說會逐字稿

Good afternoon, ladies and gentlemen, and welcome to the Pain Therapeutics year-end 2014 conference call. (Operator Instructions) As a reminder, this conference is being recorded today, Tuesday, February 4, 2014.

I would now like to turn the conference over to Pete Roddy, Vice President and Chief Financial Officer. Please go ahead.

Thank you. Good afternoon and thank you for joining us today. With me is Remi Barbier, our Chair, President, and Chief Executive Officer.

Before we begin, please note that during this conference call we may make statements that constitute forward-looking statements for the purposes of the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. Actual results or outcomes may differ materially from those that are included in our forward-looking statements. Risk factors that contribute to actual results differing from those that make up our forward-looking statements are documented in our annual report on Form 10-K and in our reports on Form 10-Q and 8-K filed with the Securities and Exchange Commission.

With that, I would like to turn the call over to Remi.

Thank you, Pete, and thank you, everyone, for joining us. To the extent that we have not had a conference call in about four years, I thought it might be worthwhile to take a few minutes and remind investors of who we are and what we do and why we feel it's important.

The proposed agenda is I will do a quick overview of Pain Therapeutics; turn it over to Pete for a brief discussion of financial results; then I will do a little bit of a guidance for 2014; and then we will turn it over to investors and the general public for questions. So, Pain Therapeutics: who are we? Where have we been all of these years?

We are a company based in Austin, Texas, and we have been around for a number of years working on a lead compound called Remoxy, and Remoxy represents what we believe to be the next generation in abuse-resistant prescription drugs. Remoxy is the subject of a Phase III efficacy study that met all of its primary endpoints under SPA.

It targets a very large market -- depending on who you believe, somewhere between $2 billion and $3 billion in size, with favorable demographics. And we have what we feel very compelling, very attractive deal terms with Pfizer, our corporate partner. Remoxy is a unique formulation of extended-release oxycodone for patients who suffer from moderate to severe chronic pain, and it is specifically designed to discourage common methods of tampering.

Remoxy is a drug that we patented. We invented it. We trademarked it. And we certainly did a deal around it, obviously, with the help of several -- many parties, not just several, including Pfizer, King Pharmaceuticals, our friends at Durect, Covidien, etc., etc. It's a long list.

But essentially this is our lead compound. It's partnered with Pfizer. Pfizer has worldwide rights to Remoxy, except as to Australia and New Zealand where we have retained those commercial rights.

For our efforts, what we have received to date is approximately $185 million cash from our partnership with Pfizer, and we will also receive another $15 million milestone payment on FDA approval of Remoxy. In addition, Pfizer pays for all commercial and R&D expenses associated with the advancement of this drug.

The real sweetener, in my opinion, to Remoxy is the royalty structure. Our royalty starts at 15% on US sales; and after the first cumulative $1 billion in sales it goes up to 20% and stays at 20% until patent expiration. The first patent to expire -- I'm sorry, the last patent to expire is somewhere in the year 2030, so a lot of time left on the meter.

At this point we don't get too many investors or too many questions around the utility of abuse-resistance. We did up until about two, three years ago. We don't get it so much anymore.

I think at this point, most investors and certainly the general public has realized that prescription drug misuse is really -- it's an epidemic. Certainly the FDA and CDC and even the White House have taken specific steps in order to address the epidemic of opioid misuse and prescription drug misuse in general.

What Remoxy does that we believe no other drugs can do is it's really optimized to resist all common methods of formulation abuse. And by all methods of abuse, we mean any type of thermal cycling, such as freezing or heating; any type of physical manipulation, such as grinding or chewing; or any type of volatilization, such as trying to snort it or vaporizing at.

It's really all the common methods of formulation abuse can be addressed and are addressed by Remoxy. And I believe that REMOXY is the only abuse-resistant drug -- abuse-resistant formulation, I should say, with published data in all these various methods of abuse.

Remoxy does have a history going back to 2008 when we got our first Complete Response from the FDA. At the time, the FDA told us there were manufacturing issues.

And again in June of 2011, FDA came back and told us the same manufacturing issues were essentially not properly addressed. We filed the first NDA; King Pharmaceuticals at the time filed the second NDA.

So this time around we do believe that Pfizer has done quite a bit of work to address the remedial CMC issues that needed to be addressed. We believe they have solved everything that needs to be solved.

We are in constant contact with Pfizer. We have very much committed to the relationship with Pfizer, and we certainly are very aware of what is going on with Pfizer. I would say that between myself and the team, we communicate pretty much on a weekly basis, sometimes every two weeks, depending on what is happening.

The game plan for moving forward is as follows. Pfizer has committed to the FDA, and the FDA has endorsed, a plan that includes -- essentially can be broken down into three studies, two of which are PK studies or pharmacokinetic studies.

The first PK study is rather small. It's about 60 patients or so. This study is ongoing.

The second PK study will be much larger. I am not sure that Pfizer has actually disclosed the actual size, so I don't want to jump the gun, but it's a multiple of 60 patients.

And the third study is a likability study or an abuse-resistance study, and that is ongoing. That study has about -- intends to enroll about 16 completers -- 60 completers, not 16. And of those 60, I believe about 18 to 20 are now enrolled; so we're about one-third of the way through the likability study.

The intention, Pfizer has stated an intention to refile the NDA by mid-2015, so a little bit over a year at this point. We do expect a six-month review, so conceivably we would be happy to announce an approval some time at the end of 2015, possibly early 2016.

Upon launch, Remoxy will be in what Pfizer calls its innovative core business unit. I believe this is a group that has a customer base in excess of 50 million patients, and some of the cornerstone pain drugs include things like Lyrica and Celebrex. So it's in the right part, within the right organization, in the right part of Pfizer.

As far as management is concerned, one thing that I absolutely pride -- we pride ourselves on is that we try very hard to be shareholder friendly. And we certainly are large shareholders in the Company.

Our cash requirements in 2013, we had guided under $10 million. Pete will give you more details about that. At this point, we have approximately a little less than $50 million in cash.

Management owns approximately 30% of King Therapeutics. So again there is this constant theme that we are very much aware of investors, both their pain and their joy, and we are in the same place as investors.

I think with that I would like to hand it over to Pete for a brief review of our financial circumstances in 2013.

Great. Thank you, Remi. We ended December with $49.8 million, which is well under that guidance that Remi mentioned as cash usage of $10 million for the year. It was more like $6.5 million.

Our net income for 2013 was $31.5 million or $0.70 a share. Earlier in the fourth quarter of 2013, we announced the amendment to our agreement with Pfizer; and our profit in the fourth quarter and for all of 2013 stems from this amendment.

The $155 million in upfront payments, outside of milestones, that we have received from Pfizer in prior years was being recognized over time through the third quarter of 2013. After the amendment, with Pfizer continuing to be responsible for Remoxy, nothing changing there, and with the abuse-resistant formulations of hydromorphone, hydrocodone, and oxymorphone all coming back to PTI, all of the deferred revenue related to the $155 million became revenue to us in Q4 -- so a little bit of arcane accounting.

Now, these payments were included in our tax returns in prior years. So while we show a healthy net income for the year, we don't have any taxes in 2013 for this revenue.

On the expense front, research and development expenses dropped to $4.9 million in 2013 from $7.6 million in 2012. In particular, both cash-based compensation and non-cash equity-related expenses were lower in 2013 than in 2012.

Our G&A expenses also dropped to $4.8 million in 2013 from $7.2 million in 2012. Again, both cash-based compensation and non-cash equity-related expenses were lower in 2013 than in 2012.

Our interest income is relatively small, but it's dropped due to lower average cash balances and lower prevailing interest rates, to a certain extent. Mainly the average cash in 2013 was lower than in 2012 because of the special non-dividend distribution that we did of $34 million at the end of 2012. The investments are conservative and relatively straightforward.

We have another non-cash item in our income statement, the benefit from income taxes, which reflects the expiration of reserves on credits that we used back in 2006 to reduce the taxes that we owed then on the large upfront payment we received under our agreement with Pfizer.

So, to sum up: the net income for 2014, $31.5 million or $0.70 a share; $49.8 million in cash; and we have no debt. Aside from the financials I will just note that we plan to file our 10-K in the very near future.

And right after we file the Form 10-K we are taking care of some routine housekeeping by filing a Form S-3 shelf registration. The shelf that we filed in 2010 expired by passage of time during 2013. We are filing the shelf right after the 10-K to replace the expired shelf in the most cost-effective manner possible.

With that, I will turn it back to Remi.

All right. Thank you, Pete. Again, I want to repeat what I started off by saying, and perhaps -- and I will keep saying it time and time again. I want to clearly make the point that we had decided to remain a very quiet company while the fate of Remoxy was out of our control. Now that the FDA has endorsed Pfizer's plan for going forward and now that we have Pfizer's written commitment to go forward, we do plan to be very active in reaching out to investors both through conference calls and non-deal roadshows and so forth.

Let's go briefly over what went right in the year 2013. I guess at some level, we are judged by our stock price, and we should be; and on that front I can say that our stock price from January 1 to December 31 in 2013 increased about 78% versus about 45% for the biotech index. So clearly investors -- certain investors, especially I would say the value investors -- have started to sniff an opportunity, a compelling opportunity, at Pain Therapeutics.

On the patent front, we have been very busy. Those who have heard my corporate presentation know that we sit on the Patent Committee, and at this point we have over 50 issued patents in the US as well as the rest of the world and a large number of pending patents. And again, the longest patent expiration is approximately 17 years from today before extensions.

On the regulatory front, Pfizer had an excellent FDA meeting in May. Essentially FDA provided written endorsement of Pfizer's plan for the remedial CMC work. And following up on that plan, Pfizer had -- ran some very successful large manufacturing campaigns in the fall.

On the finance front, as Pete just told us, we finished the year on budget. And in general, our agenda here is to keep innovation at the top of the agenda but to be very conservative with our balance sheet and certainly our cash deployment. In particular, we did decrease G&A expenses by over 25%.

And on the corporate front, the big achievement for Pain Therapeutics was getting Pfizer to commit to a Go decision, which they published in October, specifically October 22 of last year, as well as the return of three abuse-resistant drugs. Pfizer returned these drugs free and clear.

In addition, those who know us know that for a while there were rumors about the Remoxy economics being mucked around. And I have said this before, I will say it again: the Remoxy economics are intact and are not intended to change.

In any event, when we received the Go decision from Pfizer at the end of October, that really released us to go out and tell the story again. The good news is we've had a very, very good reception from investors as we begin to build the Company out around Remoxy again.

I would say at this point we probably have reached out to over 100 investors in the past three months. Granted, I would say half of those investors already knew us; but 50 new investors in three months is not a bad track record. But still, a lot of works remain.

I think one of the things that I have learned over the past couple of non-deal roadshows is that a lot of institutional investors -- I dare say most institutional investors -- do not know us. They don't know where we have been; they are not aware of the deal economics around Remoxy; and they don't know how soon the NDA is expected to be refiled by Pfizer.

So we really have a lot of work to do in terms of visibility, improving our visibility, reaching out to investors. Just going out there, doing Wall Street conferences, talking to analysts. And we will continue to do all those things throughout the year, all the way through drug approval.

The one thing that we don't talk about a lot, at least not right now, is the potential depth of our pipeline. Right now we are known as the Remoxy Company, and I like it that way. I accept that fate; that's a great fate. Again, a safer form of a $1 billion, $2 billion, $3 billion drug with a 15% to 20% royalty, to me that spells an opportunity to build a real business.

But we do have a pipeline. And unfortunately we are constrained by IP considerations, specifically by patents, in a way that we really cannot disclose and we really don't want to say much about the early-stage pipeline. The only thing we will say is that by midyear -- so June, July, August time frame -- we expect to announce at least one of our early-stage assets.

I think with that we'd like to turn it over to investors for -- and hear what kind of questions they have.

(Operator Instructions) Greg Fraser, Bank of America.

Great. Good afternoon, gentlemen. Thanks for taking the questions. Do you expect Pfizer to announce the results from either of the PK studies, or the likability study, or present the results at meetings prior to securing FDA approval?

It's a Pfizer question, so I will go out on a small limb and say typically PK results are not published, if only because -- kind of, who cares? Unless you are a drug developer, unless you are a pharmacologist, unless you're writing a script for these things, you typically assume that the PK is in place.

On the other hand, the likability data, I fully expect that data to be published, because that can be an important platform for Pfizer to eventually launch and position Remoxy vis-a-vis all the other long-acting opioids that may be out there at the time of launch. So kind of a probably not on the PK data, at least not immediately; and probably yes on the likability data.

Okay. Then what is your latest thinking on what to do with the other three abuse-resistant product candidates?

Thanks for the reminder. Again, as part of our negotiation with Pfizer, back in the fall Pfizer returned to us three opioids that they felt were -- just didn't have the market reach of Remoxy.

And I concur. I agree. While Remoxy is -- it's really measured in billions of dollars, I think the other three opioids drugs, hydrocodone, hydromorphone, and oxymorphone, are probably more $200 million, $300 million, maybe $400 million opportunities. And hard to believe, but those types of opportunities, they really don't -- they just don't move the needle for a big company like Pfizer.

On the other hand, a $200 million, $300 million opportunity could definitely move our needle. So to answer your question, we are still in the contemplation phase of what to do with these.

We anticipate developing at least one, hopefully two of the three. I think oxymorphone is the least likely to be developed, or I would say it's the third on the list. It's a tossup between hydrocodone and hydromorphone.

Part of my hesitation for saying exactly what we will do with it has to do with the fact that, again, we work with a large number of collaborators, and we are in discussions with Durect around their capabilities and so forth.

Okay. That's helpful. Have you got any unsolicited interest in those programs from potential partners?

I will give you a very short answer: yes. And leave it at that.

Okay. Then just an early-stage pipeline, I know that you have sounded excited about it for a while, but you have been constrained on what you can say. The date that you mentioned coming up later this year; just so I understand, that will be disclosing the identity of one of the programs?

Yes; again, for better or worse we are constrained by IP considerations. But what I anticipate is some time in the middle of the year we will have sufficient clearance from the patent attorneys to at least disclose the concept and provide some sort of -- both the rationale for what we are doing and a path forward for why it's important.

I would say the opportunity that most excites me is I would say probably as large as Remoxy. And we own 100% of it.

Okay, great. Thanks for taking the question.

Kevin Kedra, Gabelli.

Hi, guys. Thanks for hosting the call. Just a follow-up on some of the Remoxy questions.

You said you expect Pfizer to report out or publish on the abuse liability studies. But will we at least get notice that the PK studies have been done and were acceptable, within the guidelines of what were expected, either coming from you or Pfizer? Just to keep us updated to the status of how Remoxy is flowing through the pipeline there.

I think on the PK data I would look for an absence of news.

Okay.

It's one of those -- the absence of evidence is evidence of goodness.

Okay. But even on the -- as far as getting that study up and running, though, will we --? I mean, it's not up now. Should we just be waiting to see something on clinicaltrials.gov for that?

Or do you have a sense of when Pfizer may get that large study started? Because that seems to be the rate-limiting step here to getting Remoxy eventually back in front of the FDA.

Yes, again, we are very committed to the relationship with Pfizer. We are very much aware of what is going on. We talk to them on an ongoing basis.

At the same time, I need to, I want to preserve and will preserve our relationship with Pfizer. So I don't want to jump the gun. I will just say that everything is on track.

In my last communications to them or with them, which was this week, they told me they felt very good. Everything is working as planned.

Okay. Then moving on to the other assets that you guys have in-house now -- you mentioned that the hydrocodone, the hydromorphones, you will see those as the next ones to develop. How do you frame your thinking around which of those you will push forward?

And what sort of timing can we expect as far as how long that would take to get from where they are today to a potential FDA filing?

As we contemplate the two Hs, as we call them here, what we anticipate, what we hope to do, is by the time Remoxy is up for approval, by the time Remoxy is NDA filed, we would hope to have one or two in Phase III clinical trials. It is a tricky question to -- it is a great question; it's a little bit tricky to respond to, because there is a line of thinking that proposes that perhaps hydromorphone may not need a Phase III clinical trial.

We don't know this for sure yet. We need to meet with the FDA.

But there is a clear, rational way to think about getting hydromorphone approved possibly without going through the expense and complexity of the Phase III clinical trial. So we will know more probably, again, within the next six months or so.

Okay. Then perhaps a question for Pete. On the guidance for 2014, you guys have done a great job controlling expenses the last few years. You ticked up your cash burn guidance up to $12 million. Just wondering what is driving that.

Is that mostly R&D? If so, is that going to be a function of both the other opioid compounds plus this other asset that you could be disclosing in 2014? Or is there something else that we should be thinking about there?

It's primarily driven by the research and development that Remi described. No real change in infrastructure, but really focused on -- given our model, how the spending ramps with increased investment in those early-stage assets.

Yes, Pete has done a great job controlling expenses. And he has been here quite a while, so he is very good at it.

I would say that under Sarbanes-Oxley, it takes a lot to just stay a public company. I would say our fixed costs are somewhere in the $6 million to $8 million range, and that is just for being a public company and dealing with CPAs and attorneys and IP lawyers and so forth. And the rest is basically productive research.

Okay. Maybe just throw one last question in, just a follow-up on what you just mentioned, that you have these public company costs, which are a not immaterial amount of your overall cost structure. You have $50 million of cash on the books right now.

Given that management owns 30% or so of the Company, why does it still make sense for Pain Therapeutics to remain a public company?

As opposed to what, going private?

Sure.

Make us an offer (laughter). We are a public company. We are a public company. There are days when I wish we were a private company, if only so we wouldn't have this massive burden of dealing with SEC filings and so forth.

On the other hand, I am very grateful for being a public company. I think the capital markets have been good to us overall, over the years.

To the extent that we have deliberately made a conscious decision to stay very quiet in the past three or four years, right now we have a stock price that I believe reflects the quiet period. What we now need to do is catch up and inform investors, especially institutional investors, of what we have, why it's important, and why these are really near-term catalysts for life science investors.

Thanks, guys.

(Operator Instructions) Rajesh Patel, Red Acre Capital.

Hi. Thanks for taking the question. I would like to know whether you and Pfizer have had any discussions since the Teva versus Purdue decision that came up in January 14, and how that affects your thinking about the Remoxy market potential, if at all.

So: Teva versus Purdue, and Pain and Pfizer. It's a great question with a lot of moving parts to it.

On the IP front, I have been drilled for I have learned to perhaps not comment on other people's intellectual property; so maybe we will get that one out of the way. I think the more general question that I am hearing is: what if there is a generic form of long-acting oxycodone on the market at the time that Remoxy launches? Is that a fair interpretation?

Yes, that is exactly the interpretation I would like the feedback on.

Yes. In any other drug category, a generic market typically shrinks the entire market -- I'm sorry, the entry of a generic drug typically shrinks the entire market by 90%, usually within two, three years. But not always.

With opioids, it's different. The entry of a generic opioid typically shrinks the overall market size by approximately 50%, sometimes 60% over time.

The reason for -- the reason why it doesn't go down to 80%, 90% is because opioids are very difficult and very expensive to make, to distribute, to ship, to store, to prescribe. And there is an entire security process around these drugs that only a very small, a limited number of companies actually have the expertise and the necessary security licenses to work with opioids.

So it's not a sudden drop. It's not sudden death.

As to what might happen in two years from now, we don't know. Certainly I don't have any special insight.

What I do know is in the worst-case analysis, let's say the market goes from $3 billion in size to $1.5 billion in size, it's still a very attractive market. But I still believe that at the end of the day the opioid market -- the market for long-acting opioids will be all about abuse-resistance. It's all about abuse-resistance, all about preventing prescription drug abuse, all about saving lives.

Great. I guess -- I know you guys have been pretty quiet, sort of in stealth mode. But I was wondering, as far as your communications with FDA regarding the abuse deterrence and where FDA's thinking is, do you still hold with a view that -- I read something in the press a while back regarding, if and when Remoxy is approved that it might actually become the gold standard. Is that something you're still -- is that still the view?

Absolutely. Right now there is no gold standard of abuse-resistance in the marketplace. And there is no gold standard simply because the whole concept, the whole idea of abuse-resistance hasn't been around long enough for anyone to have evolved a gold standard.

We hope to be that company, and it really plays into the richness of Remoxy. What we have is a formulation that is both very difficult to manufacture but, more importantly, is even more difficult to abuse.

During my roadshows, my non-deal roadshows, I typically tell investors that these days, not that difficult to come up with an abuse-resistant formulation. A good chemist can come up with an abuse-resistant formulation within a couple of months.

But that formulation will typically be optimized against one, two, maybe three forms of abuse. It will not do much for all nine or 10 or however many common forms of abuse there are. Remoxy is the only formulation I am aware of that is specifically designed to prevent all common forms of opioid abuse.

That's really helpful. Then just one final question. Is all of the formulation work that Pfizer is doing right now related to Remoxy, does that directly, in your opinion, read through to the rest of the compounds that were returned to you? In other words, once they figure out to FDA's satisfaction for Remoxy, do you think that helps you leapfrog with the other compounds?

Remoxy is built on a very, very robust platform, and that platform can be applied to a number of different opioids. Which is to say that we can take that platform and use it with hydromorphone, hydrocodone, Remoxy, you name it.

So the answer is yes. A lot of the Pfizer work is directly applicable to the other three drugs that were returned.

Thanks very much. That is really helpful and we are looking forward to the future announcement in the summer time frame.

Steve Owsley, Madison Street Partners.

Hey, Remi. Thanks for the call. I am just curious, the size that you at the Pain team thinks of Remoxy as a whole in the marketplace. We understand the royalty streams and how far they go out. What is the size of that market?

As I understand the size of the market for long-acting oxycodone is somewhere between $2 billion and $3 billion in size.

Okay, is that per year in sales?

Correct.

I guess from an investment standpoint, or on this end to be trading at least currently somewhere in about $135 million of enterprise value, obviously we all know that story. What is the plan there going forward for two years?

Because if the platform is in two years, if I understand correctly, this will be marketed, this will be on the market, it seems like we are all paying a pretty cheap price at this price.

Again, I have reached out to over or close to 100 investors in the past three months, and I think your point is well taken. After going through this story, typically the number-one question I get from investors who don't know us is: what is wrong with this story? Why is this a $4 or $5 stock?

For there, what I like to say is just state the facts. Basically we have been a very quiet company for the past three, four years; and this is the type of stock market where, if you take a timeout for three years, you get a stock price that reflects your time-out.

What we have done since October 22 is massively increase the volume -- not just the volume but the number of outreach events that we will be doing with investors. As an example, we hired recently Barbara Ryan, who is now at FTI Consulting. You may know Barbara from her days at Deutsche Bank, where she was one of the preeminent Wall Street analysts.

In addition, I have got non-deal roadshows scheduled. I forget exactly when, but sometime over the next four or five weeks there is another non-deal roadshow; then we have a conference in -- do you remember? March something?

Yes.

Remi Barbier6 Another one in May or so. There are a number of things that we're doing to increase visibility.

For me, 2014 will be the year of three things. One is making progress with Remoxy; second is increasing visibility, visibility, visibility; and the third thing is coming out with the early-stage pipeline.

Okay. Thanks for your time.

Kevin Kedra, Gabelli.

Thanks for the follow-up. I just wanted to clarify something in the press release. In the press release, you guys mentioned in talking about Remoxy, you said that any moves towards risk reduction around Remoxy may accelerate your corporate strategy to transition from purely an R&D Company to a mix of R&D and product revenue.

I was wondering if you could just provide a bit more color around that comment. What sort of risk-reduction things are you talking about?

One of the things I heard during the non-deal roadshows and outreach to investors is there is this perception that there is still some sort of high risk embedded within Remoxy. I am not going to argue whether that perception is for real or not; because if it's perceived to be real then it probably is.

On the other hand, what I can say is that with the advancement of Remoxy through to PK studies and a drug likability study, I think that perception that it's still a risky asset may go away. It should go away.

And as the perceived risk of Remoxy goes away, hopefully investors come into this story, and they see the risk/reward, and they like it. And that allows us to, as we said, to move away from being a pure R&D company such as we are today to a mix of R&D and product revenue.

The other way to interpret the statement perhaps is as testimony to how shareholder-friendly we have been. I want to say that for a small life science company we have been extraordinarily -- we have tried to be extraordinarily, very shareholder-friendly.

We did a $34 million dividend payment in 2012. In 2010, we did an $86 million dividend payment. In 2007 and 2008, we bought back approximately $30 million worth of PTIE. So all told, we have returned $150 million in cash to investors; and this is before we even have a product approved.

I think that speaks to not just how shareholder-friendly we try to be, but also our confidence in Remoxy and our ability to move from being a pure R&D company to a product revenue company. Does that help?

Yes. So as you guys start moving some of those internal compounds through, into the clinic again, should we take that as a sign that you're seeing positive things on Remoxy that perhaps maybe we're not seeing?

No, I think you're seeing what we're seeing. Which is, Pfizer is fully committed; FDA has fully endorsed Pfizer's commitments; there are two PK studies and an abuse likability study.

We are very confident that Remoxy will pass all of those hurdles. I actually feel those are relatively low hurdles. It's not like we have to go through an efficacy study or any of those high hurdles.

So no, I think you see it the way we see it, which is with a lot of confidence. At the same time, we are very conscience of our balance sheet. We try hard to be very good stewards of shareholder value and balance sheets and so forth.

So it is always a juggling act between confidence and balance sheet and moving as fast as you can.

All right; thanks. Appreciate the added color.

Thank you. We have no questions in queue at this time. I would like to turn the floor back over to our speakers.

Thank you very much for joining us this afternoon for the call. We look forward to more communications, more visibility over the course of 2014. And again, thank you very much.

Thank you. This concludes today's teleconference. You may disconnect your lines at this time and thank you for your participation.