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EARNINGS CALL TRANSCRIPT
EARNINGS CALL TRANSCRIPT 2015 - Q2
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Executives

Jim Brown - President & CEO Matt Hogan - CFO.

Analysts

Annabel Samimy - Stifel Nicolaus Jim Molloy - Lynn Yaffe - Stockup Partners.

Operator

Greetings. Welcome to the DURECT Second Quarter Earnings Conference Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded.

I would now like to turn the conference over to your host, Matt Hogan, Chief Financial Officer for DURECT'. Thank you. You may begin..

Matt Hogan

Okay. Good afternoon and welcome to the second quarter earnings call. This call will begin with a brief review of our financial results and then Jim Brown our President and CEO will provide an update on our business. We will then as you heard, open it up for Q&A. Before beginning, I would like to remind you of our Safe Harbor Statement.

During the course of this call, we may make forward-looking statements regarding DURECT’s products and development, expected product benefits, our development plans, future clinical trials or projected financial results.

These forward-looking statements involve risks and uncertainties that can cause actual results to differ materially from those in such forward-looking statements. Further information regarding these and other risks are included in our SEC filings, including our 10-Q under the heading Risk Factors. Let me now turn to the financials.

Total revenue was $4.4 million in the second quarter of 2015 compared to $4.6 million in the second quarter of 2014. Excluding all deferred revenue recognized for upfront fees from our agreements, revenue from our R&D collaborations was $1.6 million in the second quarter 2015 as compared to $1.7 million in the second quarter last year.

Revenue from this source always fluctuates from quarter to quarter depending on the state of development under the various programs and our role is in those programs. Product revenue largely from the sale of ALZET pumps and LACTEL polymers was $2.7 million in the second quarter of 2015 as compared to $2.8 million in the second quarter last year.

Our gross margin on these products was around 62% in the second quarter of 2015 and these product lines continue to be strongly cash flow positive for us. R&D expense was $5.6 million in the second quarter 2015 as compared to $6.1 million in the second quarter last year.

SG&A expenses were $2.7 million in the second quarter 2015 as compared to $2.9 million in the second quarter of 2014. And our net loss for the second quarter 2015 was $5.5 million essentially the same as for the comparable period last year. At June 30, 2015, we had cash and investments of $37.8 million, compared to $34.9 million at December 31, 2014.

We also have $19.8 million in long term debt. Our cash burn rate in the second quarter if you exclude the equity raises under our ATM facility was $3.6 million. Subsequent to the end of the quarter, we also reached agreement with Oxford Finance to modify our term loan.

Adjust to the amendment is that we extended out the interest-only period and final maturity by an extra year. So the interest rate is unchanged at 7.95%, the underlying cost of capital is also unchanged. Final maturity is now July 1, 2019 and principal payments begin in early 2017. With that I would like to turn it over to Jim Brown..

Jim Brown

Thank you, Matt. We made significant progress in our three lead programs during the second quarter in fact, during the entire first half of this year. I am going to briefly review some highlights while focusing on the development programs which made the most progress in this last quarter.

I'll start with DUR-928 our Epigenomic Program and then cover our later stage product candidates that are pursuing 505(b)(2) for approval. Getting with our Epigenomic Program and DUR-928, DUR-928 is the lead molecule in this program. It's an endogenous small molecule, the first in the family of newly discovered endogenous steroid hormones.

DUR-928 represents a major discovery for DURECT and a potential major advancement for medicine. DUR-928 has demonstrated significant effects in seven different animal models plus today we announced the data from our latest animal model with DUR-928 and that is it's effect in a rat model of stroke.

To date no toxic effects have been seen in the preclinical toxicology studies conducted, nor have we seen any safety signal in the initial Phase I studies, despite achieving plasma concentrations of DUR-928 that were at least 100 times the normal endogenous levels in the subjects that were tested.

DUR-928 is an epigenomic regulator for lipid homeostasis, inflammation and self-survival. We know that DUR-928 affects these three major functions due both to our systems biology work, which elucidates the genes that are affected by DUR-928 and due to our data from various animal models of efficacy.

To be clear, we're pursuing two distinct with DUR-928 the first is an oral program that is targeting chronic metabolic diseases and the second an injectable program that is targeting acute organ injury. Today we announced positive results from brain stroke model in rats. This study was conducted by a contract research organization is Europe.

The stroke lesion was induced by a temporary occlusion of the metal cerebral artery in these rats. This study demonstrated that DUR-928 provided protection against ischemic damage in the brain. In this study a number of measures were taken at day one and at day seven after induction of the stroke lesion.

These measures were lesion volume, edema volume and T2 lesion as determined by MRI plus body weight recovery and behavioral recovery. The lesion volumes and brain edema were statistically significantly reduced compared to placebo on day one.

The T2 lesions, which is a measure of cell viability MRI were statistically significantly improved on day one as well as on day seven. The other measurements showed a consistent trend in favor of DUR-928 in this model.

The data from this stroke model provides further support to the renal ischemia model and other acute models and is suggestive of DUR-928's potential against the ischemic damage as well as other acute organ injuries. Our animal data are divided into two main categories, safety and efficacy.

With regard to safety and pharmacokinetic and toxicology conducted so far in mice, hamsters, rats, dogs and monkeys. DUR-928 has been found to be safe at all doses that were tested. These non-clinical results supported the initiation of DUR-928 in human safety trials.

Regarding efficacy, the biological activity of DUR-928 has been demonstrated in seven different animal disease models involving three animal species. Four of these models represent acute toxic or ischemic organ injury and these have been demonstrated in liver, kidney and now in brain.

Three represent the chronic disorders of liver lipid accumulation; lipid dysfunction and inflammation and fibrosis such as NAFLD and NASH. In the pharmacology studies, it's important that chronic indications, DUR-928 demonstrated improved liver morphology and reduced liver triglycerides and cholesterol in mice and hamsters fed at high fat diet.

DUR-928 also reduces fibrosis and NASH scores in a mouse NASH model.

In the pharmacology study supporting the acute indications, DUR-928 demonstrated an improved survival after injury from Acetaminophen and ethanol toxicity in mice as well as improved survival after exposure to endotoxin in mice and reduced ischemic injury in a cat and a rat kidney model and in a brain stroke model in rats.

In March we reported results from our initial Phase I safety study and in May, we announced results from the multiple ascending dose Phase I trial. Both of these studies use oral route of administration. They were single site randomized double blind placebo control studies.

The single ascending dose study was conducted in 30 subjects and the multiple ascending dose study was in 20 subjects with daily dosing for up to five consecutive days. The high dose resulted in plasma concentrations that were more than a 100 times higher than the endogenous levels of DUR-928.

DUR-928 was well tolerated at all doses and there were no severe or serious drug related adverse events. There was also no accumulation in plasma concentrations observed with repeated dosing. Dose related increases in plasma concentrations were observed with the peak plasma concentrations being achieved at two to six hours after dosing.

We're now preparing to conduct similar Phase I trials using our injectable formulation. We expect the injectable Phase I single and multiple dose studies to be completed by the end of the year. We’re pursuing two therapeutic programs for DUR-928. The first is for acute organ injury and the second is for chronic metabolic liver disease.

For the DUR-928 acute organ injury program, we will use our injectable formulation. The initial indications of interest are acute kidney injury, acute liver failure, ischemia and reperfusion injury and these indications each include potential orphan indications.

The support of animal data are from the mouse and Acetaminophen and ethanol exposure, also in mouse, a bacterial endotoxin exposure in rats, a temporary renal artery occlusion and then also in rats a brain metal cerebral artery occlusion model. The DUR-928 chronic liver disease program will use our oral formulation.

The initial indications for chronic use are non-alcoholic fatty liver disease, non-alcoholic steatohepatitis, additionally there are multiple orphan indications we plan to investigate. And the support of animal models here are for the mouse for high fat diet model, hamster high fat diet model and in the mouse a NAFLD and NASH models.

The next steps for DUR-928 are the single dose injectable Phase I study, which is set to begin this quarter. Next will be the multiple ascending dose injectable study, which is set to be begin in the fourth quarter of this year with the Phase II to begin in 2016 and multiple patient populations for both the chronic and acute programs.

We understand that replicating some of the responses that we've seen in our various animal models in man would most likely provide a substantial change in the appreciation of the value of the DUR-928 program as well as DURECT.

The question on the minds of most biotechs investors is when will the DUR-928 development program be outlined in greater detail? What will be initial proof of concept studies be? Which patient populations will be studied? Which efficacy signals or biomarkers will be evaluated and of course when will we have the data? These are the key questions for the two DUR-928 development programs.

We are currently working with KOL’s to define the patient studies we plan to conduct in 2016 and we plan to provide investors with more color into our plans later this year. I’ll now move on to POSIDUR. We were pleased with the final outcome of our discussions with the FDA and have defined a path forward for POSIDUR.

Based on the FDA feedback we will conduct a Phase III trial consisting of approximately 300 patients undergoing a laparoscopic cholecystectomy also known as gallbladder removal. This would be a randomized parallel group double blind placebo control multi-center trial that will be conducted in the United States.

The primary efficacy endpoint will be pain intensity on movement over the first three days after surgery. We believe the data from this trial will be supportive of the data we've seen in our other pivotal trials and how we repair in shoulder surgery and these three pivotal trials will support a robust NDA resubmission.

We like the surgical model and the trial design. Laparoscopic gallbladder removal is one of the most common general surgeries performed each year in the United States. There are about 800,000 procedures per year and most of these are done on an outpatient basis.

With the trend towards less invasive surgical procedures wherever possible, this would give us additional efficacy data from another laparoscopic surgery. Lastly our confidence is based on the positive experience we’ve had in laparoscopic gallbladder removal.

In a previous 50 patient cohort comparing POSIDUR to in this case an active compared bupivacaine hydrochloride, but using the same statistical methodology we will be employing in this new study, we saw a roughly 25% reduction of pain over the first three days after surgery with a P value of 0.0235.

In terms of timing, we expect to start enrolling this in the fall of this year and it will take about a year to enroll. After the last patient has enrolled, we believe it will take a few months to get topline data and then a few months, few more months to finalize reports that prepare the NDA resubmission.

After resubmission there will be a six month review for PDUFA guidelines. Finalizing the plan for this Phase III trial has allowed us to reaccelerate our partnering discussions. There is strong interest in the program for multiple parties.

The interest in POSIDUR is driven by the substantial market opportunity for two, three-day postsurgical pain product that has the potential to meaningfully reduce opioid use after surgery.

Now that we know the path forward based on our interactions with the FDA these potential commercial partners can complete their due diligence and drive forward towards a commercial proposal and business negotiations. We would like to reiterate a couple of principles.

We're not letting any licensing discussions slow down our plans to initiate and conduct this trial. We view POSIDUR as a very valuable asset such that we are open to partnership if the turns are commensurate with that value, but if further parties want to overly backend the turns then we will hold off on partnering.

We are committed to doing the right deal with the right party not to doing a deal for the sake of announcing a deal. This asset is too valuable to undersell it. Now moving on to REMOXY. On July 23, Pain Therapeutics provided an update on REMOXY and I would like to repeat a few of the things that they said.

First they're focused on the NDA resubmission and have substantially completed the transition of REMOXY from their formal partner. Second, they've recently assessed the long-term stability of REMOXY and found that stability testing at 12 months was within the current preset specifications.

Third, they earlier had announced positive topline results of a human abuse potential study with REMOXY. This study demonstrated with statistical significance that both intact and chewed REMOXY "were less liked" that's in quotes, than immediate release oxycodone on two primary endpoints.

The first was drug liking and drug high in non-dependent but recreational users.

Fourth, Pain Therapeutics stated that their previous partner had reached a written agreement with the FDA on the specific content of an accessible NDA resubmission and that Pain Therapeutics had recently received written confirmation from the FDA that this key regulatory document remains valid and applies to their NDA resubmission of Remoxy.

Finally, they have reiterated an expectation of resubmitting the NDA in the first quarter of 2016 and after resubmission, there should be a six month FDA review. As such we look forward to potential approval of REMOXY in 2016.

While there are a number of products in development, to date no new control release abuse to turn oxycodone product has been approved, and the current estimate for resubmission would mean that REMOXY would be eligible for approval in the third quarter of 2016, approximately one year from now. The U.S.

sales of oxycodone were about $2.4 billion last year, so it's a very large market opportunity. REMOXY has the opportunity to be a highly differentiated product. REMOXY takes a straightforward approach to abuse to turns, but not requiring a second agent to be added. It is an oral gel cap that is highly viscous.

It isn’t just another tablet that maybe a bit harder to crush. Even after crushing REMOXY's viscosity makes it practically impossible to inject through a needle, nor can one physically snort it. If one mixes it with common drinks in an attempt to release the drug more quickly, the oxycodone will not burst out.

So we believe REMOXY has the potential to be a best-in-class product providing the pain relief you would expect for legitimate chronic pain patients, while deterring multiple common modes of abuse. As a reminder, we have seven patents issues that go out at least into 2031 and we will receive a royalty from 6% to 11.5% of end product sales.

So even if the sales ultimately peak in the $300 million to $400 million range, out of that $2.4 billion market, our royalty streams would be quiet for period. I would now like to move to Relday. Zogenix stated the multiple dose trial in the first quarter of 2015 and they expect to have data in the third quarter of this year.

They have also stated they're targeting an end of Phase II meeting by early 2016. This is a milestone for which we receive a payment. Zogenix has stated the intent to seek an ex-U.S. partner. If they do so, DURECT will also receive a portion of what Zogenix receives.

With a product like this once the PK is established, there is no need for a Phase II study, so the next step in development would be Phase III which would occur in 2016. We also received a milestone payment for the start of Phase III. Hence we're looking forward to data from the multi-dose trial which is now just a matter of months away.

We feel Relday will be a nice product opportunity for treating schizophrenic patients. In the earlier Phase 1 trial, therapeutic plasma levels were achieved on the first day of dosing followed by control release profile over a four-week period.

Relday offers a simpler dosing regimen as compared to the current therapies because the patient would most likely not have to be wean off oral medications as they transition on to the long acting injectable.

Relday offers a subcutaneous injection rather than an intramuscular and unlike some leading injectables in this category, with Relday there is no need for reconstitution prior to use. The market research on this product is quite positive and we look forward to more data later this year and potentially having another program in Phase III in 2016.

The last program we will review today is our ORADUR-ADHD, Orient Pharma is our partner for the ORADUR-Methylphenidate product. They have the rights in certain far-east territories for which we get a royalty while we have retained the rights for Europe and the United States.

Orient Pharma has recently initiated a Phase III trial in Taiwan and expect to complete it in 2016. Although the commercial opportunity for us is not that large in Taiwan, we’re looking forward to having the Phase III data as this data will de-risk the program and make it more attractive for two potential partners in the larger U.S.

and European markets. As you may know Methylphenidate is one of the two main ADHD drugs and the ADHD market is quite a large market. As a reminder, the ADHD market in the United States was about $9 billion and grew 6% in 2014.

And features of our product which we think are a nice advantages are its rapid onset of action, its long duration, the small capsule size, minimal alcohol dose dumping and a resistance to physical tampering. A large number of young people in the United States abuse ADHD drugs and 40% of these users snort them.

With our technology that would be impossible. Our market research suggests this would be an attractive product. With that we would now be happy to take any questions that you may have..

Operator

Thank you. At this time we will be conduction a question-and-answer session. [Operator Instructions] Our first question is from Annabel Samimy..

Annabel Samimy

Hi. Thanks for taking my question.

Several questions on 928, I guess it is now tested in a number of animal models, I guess multiple interesting areas, what's works into your decision as to what area you pick? Is it going to be expense related? Is it going to be a best efficacy? Is it going to be possibly partner related? How should we think about how you move into the next area of study?.

Jim Brown

It's a very good question and interestingly as you look into the seven models, there is a commonality to the mode of protection vis-à-vis how this molecule works, but as we look to make a selection, where certainly the process is one by which we work with thought leaders and because of the unusual nature of discovering a new class of hormones, the thought leaders from around the world are quite excited to work with us;.

So we have no shortage of people to work with us, but as we look to make our selections, for our Phase 2A work and the initial payment populations, we're looking at where we can make I think the greatest impact to the payments and that would obviously reflect in the time to market and obviously then commercial return.

So we have -- certainly we're looking very hard at NAFLD and NASH and those areas where also there is a number of orphan indications both on the acute side and the chronic side where we'll be doing some of this work.

So I know I am not giving specifics now and I won't be able to until we've completed all the work in front of us, but I would expect that we would have a couple of orphan indications on the chronic and the acute side and then couple of big indications as well..

Annabel Samimy

Okay.

When you talk about the big indications, how are you able to fund all of these? Can you just give us a sense of what kind of costs are involved?.

Jim Brown

The nice thing is that Phase 2A work does not cost a ton of money and the other side of that is if we wanted to put a partnership in place, there is a lot of interest from the largest Pharma companies in the world on this thing because of the unique nature of it all.

And so if we chose to put a partnership at least I am sure we probably could, but right now, I think we can afford to do the work in front of us. I know management want to speak to that. I don't know Matt, if you want to speak to that..

Matt Hogan

I think what we're describing here are a number of Phase 2A type studies. These are not like huge patient populations. They will be relatively small. Therefore they're not that expensive and what we're really looking for are some biomarkers that would suggest utility.

So we go from an animal model with utility into showing some effect in humans before we launch into then much larger more definitive Phase II studies. So therefore the cost isn’t that prohibitive, but we would expect also to do a couple of these two or three or something like that next year..

Jim Brown

The nice thing about his is it's highly conserved. So we see the same plasma concentrations in humans and this was indentified initially in human liver cells, but then we developed an assay for it and whether it's human plasma or in hamsters mice, rats, monkeys or dogs, the plasma concentrations in normal are almost the exact same.

So it's highly conservative across all the species and its effects across the various species we tested are actually very similar.

Even when you look at these, it seems like while there is quite a variety of disease states we're testing here, whether it's stroke and ischemic renal and then cinnamon toxicity and endotoxin or septic shock and you look at the various high fat things, but oftentimes these things are associated with lipotoxicity with the things that if you look at what's going on inside the cell, why the cell dies, it's actually a very similar process and we're able to protect against that.

So what we're seeing in the chronic, we're actually seeing in the acute. It's just happening on a cell basis, one cell buying at one moment in time through effectively have acute on product effect that in the acute say either see in the acute see.

So if we can see these similar kind of results in humans, see some of these same biomarkers change I think we're going to have dramatic increased in the awareness and the confidence of what this can do even on the chronic side..

Annabel Samimy

Okay. And just a couple more questions on the areas, you mentioned orphan or some orphan drug in some very large areas but so far most of the areas that we mentioned -- that you mentioned or your studies have been pretty large areas.

Can you just give some little bit more idea of the orphan areas?.

Jim Brown

Well, we're not getting into too much. There are a number -- you can think about things like, I guess if you follow what Intercept have done, you do with the primary psoriasis on a number of orphan indications they're looking at. Certainly there are a number of lipid storage of these where we can make a difference.

On the acute side a number of these toxicities there is a much, even sub cut the population of people having specific types of surgery where you cut off the blood supply, restrict the blood supply because we're doing some surgery some place in the body that requires that, the kidneys normally see 20% of your blood flow every minute.

So just a short period of time can dramatically damage the kidneys and for us to be able to step in there and make a difference, you would see a difference within just days right and so I think as I stated previously and we talked about the renal model.

The person that we've done this with has been doing this work for over 30 years and he said this is unlike data. He has never seen results like this. It's better than it's positive control the drug that is used to treat trying to protect kidneys but they also use it for Acetaminophen toxicity in liver.

So I think we're going to have a great number of orphan indication opportunities both on the acute and the chronic side..

Annabel Samimy

Okay.

And if I can just ask one more question on ORADUR, they moved into Phase III data, does that come with any milestone payments or anything that could generate some value for you?.

Jim Brown

No, just on the way that deal was structured was they paid for multiple Phase I study. So you could pick the formulation. They're paying for the Phase III to get Taiwan and a few other countries over there. But we retain the U.S. and Europe and so in light of that kind of a structure, given that we got to keep the U.S.

and Europe and they're paying for all this data, we don’t get any milestone in their territory. And we're specifically trying to make it clear we don’t think it's like a huge commercial opportunity in Taiwan.

The benefit to us is getting that data because if that looks good, it makes the value of the whole program look more much more attractive for these bigger markets and for the bigger markets we don’t owe them anything..

Annabel Samimy

Okay. Great. Thank you..

Operator

Our next question is from Jim Molloy..

Jim Molloy

Hi guys Jim Molloy. Thanks for taking the question. I had a quick question on REMOXY the re-filing here, I know this has been just the longest road on this drug and here we are finally getting close hopefully yet again.

Can you walk you through either any potential thoughts on what PJ are we doing to make sure the thing gets through this time and any discussion you may have had with procedural partners on this product?.

Jim Brown

Well the partnership discussions will be all there. So we would only be supportive there and that would be their news to talk about. So I won’t mention anything there. But as far as the resubmission itself, you're right. It definitely has been a long road.

It's been two complete response letters, but with each one the issues have narrowed and narrowed further and further. So it's kind of like you're pudding closer to a hole unless you put like I do. You go 50 feet on the other side, typically one gets closer and closer.

So we're within the hula hoop now around that hole and in fact literally I would if you want to use this analogy too far, I would say it's a tap in at this point because they have confirmation that was received from Pfizer as to what they needed to do and they've done it. They have the one year stability on this formulation.

They've got the effective bioequivalence work all done. So I think they're in pretty good shape as close as you can get to feeling very comfortable about a resubmission this is about as close as you could possibly get to one that should go and get up the other side. So I think we're hopefully going to see REMOXY on the market here so from now..

Jim Molloy

So that is great, so it was not a Dustin Johnson type of moment, but best wishes on that.

If you take the analogy one step further, then on any discussions with partners on your other programs? I know you certainly get some products that should get closer to the market should draw some interest from large Pharma and any discussions you could talk about how those have gone?.

Jim Brown

I think we are having a lot of really great discussions around POSIDUR because if you look at the market today there really isn’t -- there is concern which is out there now by law the Justice Department is coming to them and telling them you have to say it is a 24-hour product, which we all know it was or now it was by definition of 24-hour product, with small surgeries that they've shown effect in against placebo control and that was the Bunyan and the hemroid.

We're going to be out there with shoulder, with hernia and now with gallbladder. We'll have a number of successful trials [indiscernible] hydrochloride. We'll have three full days of pain control. We'll have 60% to 80% reduction in our products from the shoulder and hernia trial. And so I think we're going to be able to really differentiate ourselves.

We're giving we know enough drug we need to give over 600 milligrams to get it to last for three days. So if one looks at anything else out there, there are two other products that are attempting to come into that space.

One is with Heron which was formerly AP Pharma and the other is iNACOL and neither giving enough drug they are in the 300 range I think milligrams and once has got a combination issue and the other has a substrate that they put into the wound that would legitimize and showed an increased rate of infection.

So I think we're in a pretty good shape if one stacks up what we have. We will have something that's put directly into the wound. Doesn’t require refrigeration. We will give three days a delivery and so I think we've got a pretty valuable asset..

Jim Molloy

I would leave with that. Thank you guys for taking the call -- the questions..

Jim Brown

Thank you..

Operator

Our next question is from Lynn Yaffe..

Lynn Yaffe

Thank you very much. As I look at your 928, one thing about NASH and acute kidney industry, they're both incredibly un-served major medical needs where drugs in the case of a [cat like Valdoxan] [ph] is failed and at NASH it looks like the drugs that Wall Street file were going to be successful drugs appear not be living up to promise.

So we've seen clinical trials and part that's injecting my own interpretation what I think common between those two diseases is inflammation and your drug seems to be perfectly positioned in terms of dealing with those and I was wondering if you've done any work in either comparing 928 to the drugs that haven't left out i.e.

[Valdoxan] [ph] which had side effect issues, but seem to be effective and perhaps your drug was what appears to have the same efficacy, but without the heart failure side effects or a NASH either with the p-pause or anything else where it might be useful.

And then secondly, if you could comment on when you would expect to enter human clinical in the acute kidney injury side..

Jim Brown

All right, first on the [toxin] [ph] we've not seen any toxicity yet and we haven't done any head to head comparisons, but we look at the genes that we influence and the genes that some of those other products you mentioned influenced and it looks as if we're going to have a broader reach.

And as I said earlier, without the toxicity even whether if you start looking at cardiotoxin and these kind of things, typically one looks at the canine models for those kind of things and we've dosed in some of these species a 1,000 times and a rate of concentration of 928 sometimes more than that, many thousands of times and seen no changes at all.

So, so far I am quite impressed with this molecule, but remember that it is something that's naturally within all of us does give me a lot of strength in feeling like we're going to find a home for this. We're going to find a dose, which it makes sense because obviously we produce it every day and we're all living and walking around.

As far as picking a Phase II timeframe for looking at protecting the kidneys and like, that's going to be a 2016 event for us and we'll be talking about in the end of year and so I don't want to hold off and I will work with thought leaders right now and some really great people and we're getting all of their input and so still little early for us on that..

Lynn Yaffe

Great. Thank you very much..

Jim Brown

You're welcome..

Operator

[Operator Instructions] At this time, we're receiving no more questions at this time. I would like to turn it back to you for closing comments..

Jim Brown

Well, thank you all for participating and if you do come up with additional questions after this, please reach out to us. We would be happy to talk to you. Thank you very much..

Operator

This concludes today's teleconference. You may disconnect your lines at this time and have a wonderful day..

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