Welcome to today’s program. [Operator instructions.] It is now my pleasure to turn the conference over to President and CEO Kevin Gorman. Please go ahead.
Good morning everyone, and thank you for joining us on our second quarter earnings call. I'm joined here this morning by Chris O'Brien, our chief medical officer, and Tim Coughlin, our chief financial officer. Before we give you an update, I would like Jane Sorensen to read our safe harbor statement.
Good morning. I want to remind you of Neurocrine’s Safe Harbor cautions. Certain statements made in the course of this conference call that state the company’s or management’s intentions, hopes, beliefs, expectations, or predictions of the future are forward-looking statements which are subject to risks and uncertainties.
Information concerning factors that could cause actual results to differ materially from those contained in, or implied by, the forward-looking statements is contained in the company’s SEC filings, including but not limited to the company’s annual report on Form 10-K and quarterly reports on Form 10-Q. Copies of these filings may be obtained by visiting the Investor Relations page on the company’s website at www.neurocrine.com.
Any forward-looking statements are made only as of today’s date and we undertake no obligation to update these forward-looking statements to reflect subsequent events or circumstances. Go ahead Kevin.
Thank you Jane. So this morning Tim is going to take you through our financials and Chris will give you an update on all our programs, and then we'll be happy to take any and all of your questions.
Just before we start out, clearly if you've had a chance to read our press release we've met all of our Q2 numbers and they are in line with the guidance that we provided at the beginning of the year. And again, Tim will take you through the details of those.
We're very happy with the way our programs are progressing so far this quarter. Abbott is finalizing the Phase III protocols and continues to be on track to initiate the Phase III program in Q4. In addition, they are progressing nicely on the Phase II trials for uterine fibroids and that is still on schedule to start late in Q3.
These are large and ambitious trials and we're quite fortunate to have Abbott as a partner. It takes their kind of experiences with disease states and the global reach to pull of these trials. But Chris will give you more detail there.
In addition to that, it's been a very successful quarter for our VMAT2 program and you'll be hearing more about what we've been putting in place in order to start our next Phase II program in just a couple of months, as well as the recent FDA interactions that we've had on the program.
Of significant importance is our receipt by the U.S. Patent Office giving us notification allowance on the composition matter patent covering our VMAT2 compound 854. That obviously is extremely important to this program.
So let's get started first with Tim, taking you through our financials.
Thank you Kevin, and good morning to everyone. Yesterday, after market close, we released our results for the second quarter of 2011. It was again another quarter that was in line with our financial plan. We remain on target for both annual and net income of $34-39 million and a net cash burn of $3-6 million for 2011, consistent with our beginning of the year guidance.
Our net income for the second quarter was $2 million, or $0.04 per share, compared to net loss of $5.2 million and our loss of $0.09 in the second quarter of last year. Our year to date net income is $4.9 million, or income of $0.09 per share. This compares to a net loss of $13.8 million for the first half of 2010, yielding a loss of $0.27 per share.
This significant improvement in operating results is a direct result of our collaboration agreements with both Abbott and Boehringer and Ingelheim, which were entered into in June of 2010. Revenue under our collaboration agreements was $12.2 million for the second quarter and $24.7 million year to date.
Amortization of upfront licensing fees was $9.2 million for the quarter and $18.5 million year to date, while reimbursement of internal and external research and development expenses resulted in revenue of $2.9 million and $6.2 million for the second quarter and year to date 2011 respectively.
Research and development expense increased in the prior quarter primarily driven by increased cost related to our VMAT2 program and earlier-stage research programs, offset partially by elagolix expenses being assumed by Abbott.
General and administrative expenses were slightly lower than budget due to lower personnel related costs. We expect research and development to moderately increase through the rest of the year as our VMAT2 program continues to move forward, including expenses from the second Phase II study, 3-month toxicology work, and ongoing product development work. We also anticipate general and administrative costs reverting back to approximately $3 million past quarter for the rest of the year.
Other income for the second quarter was comparable to the fourth quarter. However, other income year to date is lower than the previous year due primarily to a one-time gain recognized in the fourth quarter of 2010.
Turning to the balance sheet, we ended the quarter with approximately $118 million in cash, investments, and receivables from collaboration partners and our net cash burn for the quarter was right at our target of $7 million, bringing our year to date cash burn to $17 million.
So that concludes our prepared remarks on the financials. We would be glad to entertain any questions on the financials later in the call. And for those looking for additional details, our 10-Q will be filed with the SEC later today.
So with that, I'll turn it back to Kevin.
Thanks Tim. Very straightforward financials for the quarter, as I'm sure all of you will agree. Chris, why don't you take us through our clinical programs?
Thanks Kevin. And good morning to the listeners. As both Kevin and Tim have pointed out, things are moving along quite well with both our elagolix programs and the VMAT2 program. But we are really very pleased to have the partnership with Abbot as they bring a level of engagement and resources that is second to none to this development program.
There are multiple parallel streams of activities going on currently with Phase I, Phase II, and Phase III programs. As Kevin mentioned, the uterine fibroids trial is moving quickly towards beginning screening later in this quarter and multiple sites are up and running across the U.S. getting ready for this trial to get underway. You'll see details of the trial as it gets posted on clinicaltrials.gov once we get closer to the start time.
The massive initiative is getting the Phase III program up and running in Q4 of this year and we've been working intensely with Abbott to identify qualified investigators and sites, getting them up to speed and online, getting materials prepared, finalizing some details of the Phase III protocol, and a very pleased with the progress that's being made there.
As Kevin mentioned, this is really a substantial undertaking. No one has seen this level of commitment to an endometriosis program before, and this is being done very expertly and carefully by the collaboration between Abbott and Neurocrine. So very excited, very pleased, and really know we have the right partner and are in good hands with this program.
In addition to the clinical activities we are now working on the publication and presentation aspects of this development initiative and in particular we're very excited to be attending and participating in the World Congress of Endometriosis. This will be held in September in Mont Pellier, France, and this event occurs only once every three years.
This is a very well attended, very important meeting, and we are fortunate that we've had multiple abstracts and presentations accepted for the meeting and you'll see presentations on double-blind placebo controlled trials, open-label extension data, as well as some of the health outcomes and quality of life initiatives that are part of this program.
This is just the beginning of what I expect will be a multiyear substantial effort on publications and planning. Abbott truly has some terrific resources in that respect. So moving from elagolix to the VMAT2 program, 98854, our internal name/number for the compound, as Kevin mentioned, we've had a lot of activity in the past few months.
I think most importantly for us, since we last spoke, have been a very successful pre-IND meeting with the division of psychiatry products here at the FDA. I think as most people know, I wanted to establish a foundation, a basic data package, if you will, before I sat down to meet with the FDA. And so rather than starting with an IND in the U.S., we started with CTA in Canada to complete the two Phase I trials, a single ascending does and a multiple ascending dose, and then move into a small open-label Phase3 trial in patients with moderate to severe tardive dyskinesia.
This was completed in Toronto and very successfully by a very capable and experienced tardive dyskinesia investigator. And we got the confirmation that we needed, that we were seeing the kinds of effects that were clinically robust and in the dose range and exposures that we had predicted based on PKPD modeling and preclinical data.
With that package well in hand, we then submitted a request for a pre-IND meeting. This was held in June and it was a terrific meeting. We had a very engaged review division. They are very pleased that someone is pursuing what is seen as a very important and, to use the cliché, unmet medical need.
Nothing has been seriously developed for tardive dyskinesia for a very long time, and this is a problem that did not go away with the advent of atypical antipsychotics. And in fact, with the increasing widespread use of antipsychotics for conditions outside of schizophrenia, the actual prevalence of tardive dyskinesia has grown.
Some of years of may be aware that historically some drugs have been granted orphan designation for tardive dyskinesia and early on in our development program a couple of years ago, we expressed interest in possibly achieving orphan designation for this compound. Well, things have changed, and the epidemiology of tardive dyskinesia suggests that in fact this is a more widespread problem than previously appreciated.
In fact, we approached the orphan drug division to see about orphan status for our program for tardive dyskinesia and it was their opinion that in fact tardive dyskinesia can no longer be considered an orphan designation, that there are very many more than 200,000 patients with tardive dyskinesia.
If you look at not just the 10 or 15% of the schizophrenia population with the prevalence of TD, you're talking about widespread use, particularly as atypicals in both unlabeled populations such as bipolar disorder and off-label use in dementia in elderly patients, this is a subsequently number and I don't think we'll be able to proceed with the tardive dyskinesia indication for the targeted population.
So the important thing, obviously, is we had this meeting with the psychiatry products division and had a very engaged set of reviewers who gave us very clear and consistent guidance and this fits very well with the expected IND openings clinical trial that we will be beginning in actually just a few weeks' time.
After the pre-IND meeting, we have submitted our IND to the FDA in July, earlier this month, and the way this works now we have told them here's the clinical trial that we're going to do. And unless we hear back from them within 30 days that there's some other data that they need or issues that they need addressed, we will continue as planned.
What that means is we've identified the investigators and the clinical sites for the trial that we will do. This is the so-called 1101 trial. You can find out some details about this. It's posted on clinicaltrials.gov. And we will be carrying out the kickoff activities in August and begin the trial in September. This is a crossover trial, two weeks active treatment or two weeks of placebo, and we will be using as the primary end point the standard assessment tool, the Abnormal Involuntary Movement Scale, or AIMS, as recommended by the FDA and as used historically for the assessment of tardive dyskinesia.
The trial itself is a very crisp, clear way of assessing what we think is at the low end of the effective dose range, and at a dose above what we predict to be the effective range, 12.5 and 50 mg. This kind of separation or non-overlap of dosing was deliberately chosen and this is the longest duration trial that I can currently do given the preclinical toxicology data that has been generated by our preclinical group here at Neurocrine.
As Kevin mentioned, we have already gotten well into the three-month toxicology studies. When this data is available, at the end of year, as long as there are no surprises or problems, this will enable us to go into the three-month or longer duration Phase II trials that are currently planned for first quarter of 2012.
So the 32-person crossover 1101 trial is set for study related activities, undergoing kickoff activities in August, and studies start in September. And with data read out in Q1, presuming activities go as planned, and then based on that crossover trial data and the availability of three-month toxicology data, we will then plan on initiating additional clinical trials in 2012. And we'll have a lot more detail for you about the scope of the program in 2012 and the range of studies that we plan to do, and other related activities, as we get closer to that time period.
So very happy with the VMAT2 progress, moving along very nicely, very positive and productive with the FDA, and lots of activity ramping up, as Tim said, spending more money this year and looking forward to a very productive winter and spring with this progress. And some data read out early in Q1.
The next program I want to provide some update is the Urocortin 2 program. Again, as we've said before, this is an activity where we have reached out to several academic collaborators who have been busy with some work that is supportive of the Neurocrine goals, although these activities are run by our academic colleagues.
So the cardioendocrine results group in Christchurch is completing the enrollment for the acute decompensative heart failure trial known as the UNICORN study (that's the acronym). Their target, as we've progressively stated, has been to randomize a group of 50 patients with acute decompensative heart failure and then also a subset of that 50 will undergo right heart catheterization to look at the impact of Urocortin 2 infusion versus placebo on top of standard of care in the very ill patients treated in the hospital.
Now, if you follow the world events, you know that our colleagues in Christchurch have been not only doing their normal work and the UNICORN trial, but they've been struggling with tremors and earthquakes, etc. So in our last conversation with them they were just shy of the 50 subject recruitment goals and they anticipated finishing up recruitment sometime in the August-September timeframe. As soon as that data is available we obviously will share those results.
Again, this is a program that they are running as a single-center trial. It's not a Neurocrine-run initiative. We support them with [inaudible] drug and regulatory documents, etc. But we're very much looking forward to seeing what they have come up with in this import trial for Urocortin 2.
The specialized mechanism of action Phase I and early Phase II studies that are being funded in Scotland by the British Heart Foundation continue to be underway, and we were in contact with them this week. Those are moving forward nicely. We are supplying them with some more study drugs and as soon as data becomes available from that group. Again, its early mechanistic-type translation work, not critical for us finding a partner for Urocortin 2, but nonetheless interesting and important in building up a compelling story for this drug. We'll share that data when it becomes available.
So I've talked about the three prominent programs, elagolix, VMAT2, and Urocortin 2. We're very happy with the progress. Our teams are working very hard, and we are on track for uterine fibroids, endometriosis, tardive dyskinesia, and heart failure.
And with that, I'll turn it back to Kevin. I look forward to your questions as they come up.
Thank you Chris. In addition to everything that Chris outlined there, our research team continues to work on a number of programs. They've been progressing all of these quite nicely. We'll talk about them as they start nearing preclinical and the clinic. They've nearly completed work on our VMAT2 backup compound, and this is in keeping with our philosophy of enhancing and derisking all of our clinical programs with a strong research effort utilizing our platform.
Now, with this background of this call, I'm very happy now to entertain your questions.
[Operator instructions.] And we'll take our first question from Thomas Wei with Jefferies & Company. Your line is open.
Thomas Wei - Jefferies & Co.
Thanks, just on the endometriosis program, do you have any update on whether or not Abbott has sat down with the European regulators on endometriosis and whether or not they're going to accept the U.S. package or require you to run a 12-month [inaudible] control trial? Any update there?
No, Abbott has not shared details of that. They are in discussions with various European regulatory experts and in the process of doing that, but no details have been shared, primarily because the massive focus has been on getting the U.S. pivotal trials up and running.
Thomas Wei - Jefferies & Co.
And on uterine fibroids, can you give us a general sense of when data might be expected from that study? And would you be looking at a primary end point like uterine bleeding or some other surrogate marker for activity.
While the details haven’t been fully announced, it's very clear if you look at recent development initiatives for uterine fibroids, for example, the expertise at Abbott had been working at TAP on Asoprisnil, the primary end points for these modern uterine fibroid development efforts has been uterine bleeding, as you point out. And so that would be consistent with this Phase II trial that Abbott is about to start. This is a big trial. Again, you'll see details once it's finally posted, and three months in duration. So with recruitment, starting the trial in the fall, recruitment, three months treatment and followup, I think one could estimate that you'd see data later in 2012.
Thomas Wei - Jefferies & Co.
And just a couple on the VMAT2 program. Just wanted to understand with this type of mechanism and with this AIMS scale, two weeks of dosing, would you have expected to have seen maximal activity with a VMAT2 inhibitor? Or is this just going to be a partial look at early efficacy? And then is there any sort of anticipated preclinical talks that you would expect at very high doses of a VMAT2 inhibitor?
Good questions. With this mechanism, VMAT2 inhibition typically produces a fairly prominent effect within days of starting treatment. I do think there is a pharmacodynamics effect which is an increasing, cumulative benefit that occurs over time above and beyond that which is associated with reaching steady-state exposure of the drug.
The nature of that kind of, how long does that plateau take to level out, is one that we will be exploring, but you see the overwhelming majority of the clinical response within that first two weeks. How much more improvement might you get with an additional month of treatment? It might be in the 10% range. It might be in the 15-20% range. I don't know Thomas, and that's why we'll do that.
The maximum duration that I can do based on the currently available preclinical data is two weeks, and so that's why we're doing it. In the 1001 trial that was conducted in Canada, we saw very robust effects by day eight to nine, and there was a slight additional improvement by day 12. But you were on the flattening part of the curve, not the accelerating part of the curve.
And as far as the preclinical work, obviously these are still early days. We haven’t even gotten the three-month data back, and I'd ask you to kind of hold that question until we have some data to talk about. Obviously one could speculate any time you have a drug that at supertherapeutic exposures that you would see in preclinical toxicology studies you would expect to see exaggerated pharmacology. And these are monoamine depleters, so those typically the dose-limiting kinds of things in the trials rather than off-target toxicology. But we'll have to gather some more data and then we can have a more informed discussion about that.
And we'll take our next question from Phil Nadeau with Cowan & Company
Phil Nadeau - Cowan & Company
First, on the Phase III program form elagolix, as Abbott has moved towards initiating that program, have they made any substantial changes versus the design that you've discussed in the past? Has anything notable been altered?
No, in fact we have good agreement on the coprimary endpoints and have had great positive recent interaction with the Division of Reproductive Products. I'm happy to say that the nice relationship that Neurocrine has enjoyed with that division has now been picked up with Abbott and the division, so that's very good.
The trials, as we've previously given guidance to, 6 month pivotal trials with placebo control, and still women with moderate to severe endometriosis. Still post-treatment open-label extension. Still post-treatment DEXA follow up to secure that no significant redundant in bone mineral density is present. So those aspects haven't changed. There's some nuances and things that have been fine tuned to meet Abbott's needs. But nothing that substantially changes the program.
Phil Nadeau - Cowan & Company
And how does Abbott plan to deal with the issue of use of oral contraceptives in this market? It seems like if elagolix could penetrate that part of the market it would obviously massively expand the potential. Have they planned any marketing studies or head to head comparisons versus oral contraceptives? Maybe not in the Phase III program, but a Phase III-B or Phase IV program.
If I could just grab a first whack at that Chris. Abbott's Phase III or Phase IV program has not been fully developed so we couldn’t really speak to that.
As far as the oral contraceptive market, the oral contraceptive [inaudible] were quite well in the very early mild stage of the disease, which is about a third of the population. The two-thirds is what we're aiming for with the product, the moderate and severe populations. So as far as doing a head to head efficacy study, that is one that we'll have to wait and see if that would ever be done.
As far as utilizing the two together, because recall that elagolix is not a contraceptive method, then that will be explored about using each of these drugs together. But not as an additive for efficacy. More just to inhibit [inaudible]. Chris, do you want to add anything to that?
Two things I would point out. You won't see a head to head study, because oral contraceptives are not indicated for the treatment of endometriosis. And so I don't think you'll find anybody trying to open an IND for a new indication for oral contraceptives. And the second thing to point out is that the combination of elagolix and an oral contraceptive is not being looked at in patients with endometriosis. What studies will be done are simple drug-drug interaction studies looking at PK and safety, etc. So just to make sure that there is some information about what the effects of elagolix are on or contraceptive metabolism and exposure and vice versa.
Phil Nadeau - Cowan & Company
And one last question. On Urocortin 2, I know you've mentioned that your collaborators in New Zealand would put out the data whenever they have it. Do you have a sense of whether that's likely to be a Q4 event or something that happens early in 2012?
Well, I'm hoping it's this year, for sure. But obviously we don't control that. I would even hope that we get a hint of some things in the kind of September-October timeframe. But I'm not controlling the data scrubbing and the database lock and those kinds of things. So as soon as we hear something obviously we'll share it.
[Operator instructions.] We'll take our next question from Ian Somaiya with Piper Jaffray. Your line is open.
Ian Somaiya - Piper Jaffray
Chris, I missed some of your initial comments, and I apologize if you already covered this, but I'd love to get a sense of breadth of the applicability of the VMAT2 program. Maybe if you could just review for us where VMAT2 is indicated, where proof of concept has been established, and what needs to happen for you to pursue some of those opportunities.
Thanks Ian. Those are good questions. No, I didn't specifically go over that. The vesicular monoamine transporter 2, in humans, is primarily located in the brain, and more specifically in the region of the basal ganglia called the striatum. It's critical for the control of movement and has been implicated in the full range of hyperkinetic movement disorders. So whether that's a dyskinesia in the tardive setting, that is after an exposure to most often a neuroleptic, or if it's a dyskinetic syndrome such as chorea, associated with a neurodegenerative disease, whether that's Huntington's disease or Wilson's disease or one of the many other hyperkinetic syndromes, or whether it's another hyperkinetic syndrome that has a dopaminergic foundation such as a tic disorder in Tourette's Syndrome.
All of these things are hyperkinetic conditions where VMAT2 potentially is an applicable therapeutic target. Now, proof of mechanism has been established in this regard because of the longstanding use of tetrabenazine, a medication that was initially developed by Hoffman LaRoche in the late 50s and early 60s for the treatment of schizophrenia. Again, a hyperdopaminergic condition if you will. It was effective, but it was eclipsed by the typical antipsychotics of the 1960s.
Tetrabenazine was approved for the treatment of hyperkinetic movement disorders in the early '70s in the UK, and then over the next 20 years a variety of Anglophile and subsequently other countries around the world had also approved tetrabenazine for the treatment of hyperkinetic movement disorders. And by that, they were lumping in tardive dyskinesia, chorea, tic disorders, a range of conditions that had these involuntary movements.
As you know, when tetrabenazine was approved as Xenazine in the United States a couple of years ago, it was approved specifically for the chorea associated with Huntington's Disease and that's where the orphan designation was given, and that's the only indication for Xenazine in the U.S. And there's a very well controlled REMS program and specialty pharma distribution for Xenazine. So that drug is just for Huntington's Chorea.
So we know the mechanism works, and that was not the challenge. The challenge was to have a very selective molecule with no off-target effects, with a PK profile that fostered just dopamine modulation without impacting other monoamines so as to avoid some of the unwanted potential side effects, for example depression with serotonin depletion, and to do so with once-a-day dosing and a very clean safety profile. No QTC prolongation, no off-target effects, etc. So that's what we're doing with our compound.
We know the mechanism works. There's a whole range of hyperkinetic conditions that potentially could be explored as indications. We're going after tardive dyskinesia as this is an import medical need, unmet. No drugs are approved for this. There are no drugs being developed for tardive dyskinesia, and as I mentioned earlier this is no longer considered an orphan indication given the much greater prevalence of TD in the U.S. than people had previously appreciated.
Now Tim points out that I may have misused a word when I was speaking earlier in the call. I talked about proceeding with a tardive indication. We are not proceeding with trying to get orphan status based on what the orphan division has told us. This is a much greater number of patients out there than orphan status, and so we are not going after orphan as has been discussed in previous years.
So that's the market. I hope that addressed your question.
Ian Somaiya - Piper Jaffray
It did. The only followup I'd have is logically when can you pursue those other indications? Is it a bandwidth issue? Is it financial constraints that you're under? Just curious. Given the large market segment that this [inaudible] area could address, and the multiple drugs that you have on hand.
Absolutely. So what we wanted to do, there's a very logical sequence and we are marching down that path. As I said, we submitted the IND this month in the U.S. We'll have the crossover trial in tardive dyskinesia this fall.
And we will plan on, once we have a solid dose formulation, immediately going into a tic disorder trial in adults early in 2012 and if we see proof of efficacy and safety tolerability in adult Tourette's patients with moderate to severe tics, we would then do a PK bridging study for adolescents and children, because the bulk of people who suffer from disabling tics are in fact adolescents. And I will go into that population if the adult study looks good.
The PK bridging study gives us guidance on dosing, and of course I'm still waiting until I get the three-month toxicology, because I'm going to want to do a longer-term trial in the target population, a proper Phase III dose response study in children with moderate to severe Tourette's. And hopefully I can get that rolling later in 2012.
So absolutely. We've mapped out a whole series of alternatives. This is the plan that I mentioned in my earlier comments that we'll be revealing or unveiling as we get closer to those dates.
At this time I would like to turn the call back over to Kevin Gorman for any closing remarks.
Thank you very much. I anticipate that when we speak next at our third quarter call that we're going to have a Phase II trial ongoing in tardive dyskinesia with 854 and Abbott will have begun the Phase II trial in uterine fibroids. So a lot is going to be happening in third quarter.
I thank you all very much for participating today, for the excellent questions. We look forward to speaking with you in the future and hopefully some of you can keep track and get over to France [inaudible] presentations that we'll be making at the World Congress of Endometriosis in September.
Thank you all, and take care.
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