Medivation, Inc. Q1 2008 Earnings Call Transcript

Medivation, Inc. (MDVN)

Q1 2008 Earnings Call Transcript

May 1, 2008 4:30 pm ET

Executives

Monique Greer – IR, WeissComm Partners

David Hung – President and CEO

Patrick Machado – SVP and CFO

Lynn Seely – Chief Medical Officer

Analysts

Michael Yee – RBC Capital Markets

Ian Sanderson – Cowen and Co.

Kim Lee – Pacific Growth Equities

Andrew Vaino – Roth Capital

Raymond Myers – Emerging Growth Equities

Bill Tanner – Leerink Swann

Han Li – Stanford Group Company

Presentation

Operator

Good day everyone and welcome to today's Medivation first quarter 2008 financial results conference call. This call is being recorded. I would now like to turn the conference over to Ms. Monique Greer. Please go ahead.

Monique Greer

Thank you. On the call with me today from Medivation are Dr. David Hung, President and CEO; Patrick Machado, Chief Financial Officer; Lynn Seely, Chief Medical Officer; and Rohan Palekar, Chief Commercial Officer.

We issued a press release earlier today, a copy of which can be found at medivation.com, in the news section. Before we begin, I would like to remind you that various remarks that we make on the call, including those about our product development programs, clinical trial results, future financial plans and prospects, growth opportunities, and competitive positions constitute forward-looking statements for the purposes of the Safe Harbor Provisions of the Private Securities Litigation Reform Act of 1995.

These forward-looking statements and all other statements that may be made on this call that are not historical facts are subject to a number of risks and uncertainties that may cause actual results to differ materially. We refer you to our annual report on Form 10-KSB for the year ended December 31, 2007, which includes information about factors that could affect the company's financial and operating results. These forward-looking statements speak only as of today of this presentation and we disclaim any obligation to update these forward-looking statements.

With that, I would like to turn the call over to Dr. David Hung, President and CEO of Medivation.

David Hung

Thank you all for joining us today. Before I begin, I'd like to apologize for my voice. I'm just getting over a cold and a bout of laryngitis, so I'm a bit vocally challenged today, but I'll do my best to speak intelligibly and will invoke the help of my colleagues to answer questions during the Q&A.

We're pleased to share with you our recent clinical and corporate progress and significant accomplishments. After my recap of recent milestones, Pat will provide an overview of our first quarter 2008 financials and then I will conclude with the summary of important goals for 2008.

At Medivation, we're dedicated to developing product candidates as rapidly, efficiently and cost effectively as possible, as patients are in desperate need of novel, more effective treatment options. During the first quarter of 2008, we executed against this vision and made significant progress with our product candidates, Dimebon and MDV3100.

Dimebon is an orally available small molecule that we are currently evaluating for the treatment of mild to moderate Alzheimer's disease or AD, and mild to moderate Huntington's disease. Our data suggests that Dimebon has a novel mitochondrial mechanism of action that makes it a promising potential treatment for neurodegenerative diseases including Alzheimer's and Huntington's.

During the first quarter, we held a successful end of Phase II meeting with the U.S. Food and Drug Administration. The FDA recognized our previously completed trial of Dimebon in patients with mild to moderate AD as pivotal and allowed us to proceed to a confirmatory pivotal Phase III trial. This is a significant step forward for Medivation as we now have clear regulatory guidance on the pivotal trials required to seek marketing approval for Dimebon in the U.S. Based on this meeting, we plan to begin a pivotal confirmatory Phase III trial of Dimebon in mild to moderate AD and are on track to begin the trial this quarter.

The results of our first pivotal trial of Dimebon in AD were robust. After six months of treatment, which is the duration of dosing used to approve every drug on the market for mild to moderate AD, Dimebon showed significant improvement above placebo on five of the five end-points measured, including the Alzheimer's Disease Assessment Scale-Cognitive subscale, the ADAS-cog, and the Clinician's Interview-Based Impression of Change plus the caregiver interview, the CIBC-plus. These are the two end points that have been used to approve every drug registered in the U.S. and Europe for mild to moderate AD.

The physical significance of Dimebon's effects on both these key measures was achieved with the P value of less than 0.0001. After a year of dosing, Dimebon caused even greater overall treatment effects over placebo than have been seen after six months. This increasing treatment effect over time is suggestive of disease modification. Other longer studies with additional end points will be required to bear out and make this claim.

In March and April, we presented results from three separate sub-analyses of data from this first pivotal trial of Dimebon in AD. These analyses yielded additional findings demonstrating broad improvements in behavior, daily function, and memory and thinking in Dimebon treated patients, as well as critical caregiver related benefit over a one year period.

At the annual meeting of the American Association for Geriatric Psychiatry last month, Dr. Jeffrey Cummings, the Augustus Rose Professor of Neurology at the University of California, Los Angeles and the Director of the UCLA Alzheimer Disease Center, presented neuropsychiatric data showing that Dimebon treatment resulted in improvement over placebo at 8 of the 12 sub-domains of the neuropsychiatric inventory or NPI.

Improvements were seen in depression, apathy, hallucination, irritability, and motor disturbances. These findings are significant because behavioral problems in AD patients are some of the most distressing issues facing caregivers and one of the leading causes of institutionalization of Alzheimer's patients. In the presentation by Dr. Cummings, the behavioral improvements caused by Dimebon resulted in a significant decrease in caregiver distress at both six months and one year.

At the annual meeting of the American Academy of Neurology, which was held two weeks ago in Chicago, additional sub-analyses were presented. Dr. Rachelle Doody, Professor of Neurology and Effie Marie Cain Chair and Alzheimer disease researcher at Baylor College of Medicine presented data showing that patients taking Dimebon experienced significant improvement in their ability to perform daily tasks over a one year period compared to placebo. This improvement allowed caregivers to save an average of nearly one hour each day caring for patients after just six months of treatment.

The benefits of Dimebon were seen in the most basic human functions such as eating and toilet use, as well as in more complex activities such as phone use, conversation, meal preparation, traveling, keeping appointments, reading, and using household appliances. In some, Dimebon improved the overall function of these patients.

In addition, Dr. Steve Ferris, the Gerald and Dorothy Friedman Professor of Psychiatry at New York University and the Director of NYU Alzheimer’s disease center presented data demonstrating that Dimebon treated patients showed broad improvement in the key aspects of cognitive function over a one year period compared to placebo. The improvement occurred not only in memory and language but also in more complex functions such as awareness of time and place and praxis, the process of getting an idea and initiating and completing a new motor task. To our knowledge, clinical effects of this breadth, magnitude and durability in AD have not previously been demonstrated with any other drug in a well controlled one year study.

We remain on track to begin our confirmatory Phase III AD trial this quarter. Given the robust results seen in our first pivotal trial, our guiding concept with the second pivotal trial is to change as little as possible in order to maximize our chances of confirming the prior results. For this reason, the primary end points, duration of treatment and patient inclusion and exclusion criteria in a confirmatory pivotal trial are all substantially identical to the previous trial. The primary differences are that the confirmatory Phase III trial will be global and will test two doses of Dimebon.

The Phase III trial will enroll approximately 525 patients with mild to moderate AD at sites in the U.S., Europe, and South America. We expect to have 60 to 80 sites, approximately a third to half of which will be located in the U.S. Patients will be randomized to one of three treatment groups, the same dose of Dimebon study in our first pivotal trial, a lower dose of Dimebon, and then placebo. Patients will be treated for six months and may not be taking any other Alzheimer’s disease drugs during the trial.

After completing six months of treatment, all patients including placebo patients will be offered the opportunity to receive Dimebon in open label extension. The co-primary end points are the ADAS-cog and the CIBC-plus. Two out of three patients enrolling in our confirmatory Phase III trial will receive Dimebon immediately and all patients will have the opportunity to receive Dimebon in our open label extension after a period of six months. We believe that significant numbers of AD patients and caregivers will find enrollment in our Phase III trial to be a very attractive option.

We expect to conclude this confirmatory Phase III study in 2010 to enable submission of a marketing application later that year. This quarter, we also began a Phase I trial to test the safety and tolerability of Dimebon when given to AD patients concurrently with Aricept, the leading marketed AD drug.

We also completed this quarter 18 months of dosing in the open label extension of our first pivotal AD study. In our open label extension, all patients who completed 12 months of dosing on a blinded basis were allowed to receive Dimebon on an open label basis for an additional 6 months for a total human [ph] period of 18 months. In other words, patients previously receiving Dimebon continue to do so. All patients previously randomized placebo cross over to Dimebon. We will be presenting these data at a medical meeting next quarter.

We are excited about the progress that we've made in the clinical development of Dimebon for AD and are working hard to bring it to market so patients can gain access to a drug that might truly improve how they and their caregivers live with this terrible disease.

We're also studying Dimebon in Huntington's disease. On March 18, we enrolled the last patient in our randomized double blinded placebo controlled Phase I/II trial, which is being conducted in collaboration with the Huntington's study group. We anticipate completing dosing in the second quarter and reporting top line data shortly thereafter. If the result of our Phase I/II trial are positive, we intend to proceed to a Phase III trial this year.

I would now like to turn to MDV3100, our novel androgen receptor antagonist, currently in a Phase I/II clinical trial for the treatment of castration-resistant prostate cancer, also known as hormone refractory prostate cancer. As background, this Phase I/II trial has enrolled approximately 90 patients with castration-resistant prostate cancer who have failed current standard hormone therapies and/or chemotherapy. These patients will have been considered standard treatment failures based upon clinical or imageable disease progression and/or rising levels of PSA or Prostate Specific Antigen, a well recognized serum marker of prostate cancer burden. The end points are safety and pharmacokinetics, serum PSA levels, effects on clinical and imageable disease, and certainly [ph] tumor cell counts. PSA levels are measured monthly.

At the April AACR meeting at San Diego, Dr. Howard Scher, Chief of the Genitourinary Oncology Service at the Memorial Sloan-Kettering Cancer Center in New York and the principal investigator of the study, presented preliminary data from this trial during a special late breaker clinical plenary session. The data showed that MDV3100 continued to reduce serum levels of PSA after 12 weeks treatment in a group of patients given 60 milligrams of MDV3100, the lowest dose tested in our expansion cohorts.

In addition, Dr. Scher's AACR presentation also included PET scan data showing that MDV3100 effectively blocks its target, the androgen receptor and this was correlated with the decrease in metabolic activity of the tumor. We are encouraged by the results observed at this low dose of MDV3100 and are testing higher doses to asses until its [ph] response. Additional data from this ongoing trial will be presented at the upcoming ASCO annual meeting to be held in Chicago from May 30 to June 3.

We are very pleased with our recent progress as we remain focused on the rapid development of our novel lead core product candidates that have the potential to effectively treat serious diseases with critical unmet medical needs.

I will now turn the call over to Pat who will review the financial results and provide guidance for 2008.

Patrick Machado

Thanks very much, David, and good afternoon everyone. Today, we released our financial results for the first quarter ended March 31, 2008. I will review some of the highlights and refer you to the press release issued earlier today for the full detail.

We reported a first quarter net loss of $15.5 million or $0.54 per share, compared with a net loss of $5.6 million or $0.20 per share for the same period in 2007. Total operating expenses for the quarter were $15.9 million compared to $6.2 million for the same period in 2007. These figures include non-cash stock-based compensation expense of $2.1 million in the first quarter of '08 and $1.2 million in the prior year's quarter.

Our operating expense increase occurred primarily in research and development, which grew to 77% of total operating expenses in the first quarter of '08 from 72% of total operating expenses in the first quarter of '07. Our research and development expense increase was driven primarily by significantly expanded clinical development of both Dimebon and MDV3100, including initiation of our ongoing Phase II clinical trials of Dimebon in Huntington's disease and our ongoing Phase I/II clinical trials of MDV3100 in castration resistant prostate cancer and preparation for our upcoming confirmatory Phase III clinical trial of Dimebon in Alzheimer's.

We expect total operating expenses for 2008 to be in the range of $55 million to $65 million, excluding non-cash stock-based compensation expense. This forecast includes the work necessary to keep us on track to achieve our publicly disclosed development milestones, including our goal of applying for U.S. and European marketing approval of Dimebon for Alzheimer's disease in 2010 and to continue building out our business infrastructure.

In building this forecast, we made the financially conservative assumption that all of our ongoing clinical trials will succeed and that both Dimebon and MDV3100 will remain unpartnered throughout 2008.

At March 31, 2008, we had cash and cash equivalents of $32.9 million and remaining capacity of $78.8 million under our committed equity line of credit facility with Azimuth Opportunity Ltd., which we can draw upon at our discretion.

With that, I will turn the call back over to David.

David Hung

Thanks, Pat. We anticipate steady milestone achievement and news flow in the second quarter and remainder of 2008. In this story [ph], our confirmatory pivotal Phase III trial of Dimebon in AD this quarter, we expect to, one, conduct multiple pivotal trial of Dimebon in AD for marketing and reimbursement purposes and to provide a safety database of approximately 1500 patients as part of our marketing application. Two, report 18 month open-label extension data from our first pivotal trial of Dimebon in AD at a medical meeting next quarter. Three, complete our ongoing Phase II study of Dimebon in Huntington's disease in the second quarter and report topline results from either after. Four, begin global Phase III clinical studies in Huntington's disease if the results of the Phase II clinical trial are supportive. And five, present additional data from our ongoing Phase I/II study of the MDV3100 in prostate cancer right after later this quarter and complete the study by year-end.

On behalf of the management team, we thank you for your interest and look forward to communicating with you on our progress in advancing the clinical development of Dimebon and MDV3100 throughout the year. With that, we will be happy to answer any of your questions. Operator, please poll for questions.

Question-and-Answer Session

Operator

Thank you. (Operator instructions) We will take our first question from Michael Yee of RBC Capital Markets.

Michael Yee – RBC Capital Markets

Great. Thanks. Congratulations on the products so far, David. Couple of questions. Just so we have our expectations in reality, what exactly – what type of data are we going to get at ASCO? Are we going to have the 60 milligram cohort followed out a number of months? Are we going to get the second and third cohorts reported out as well?

David Hung

Obviously, under the embargo rules of ASCO, we aren't allowed to disclose the details of the presentation and advancement of the meeting. We will be presenting more data. As we said, we've gone – dosed higher and more cohorts and at AACR, we only presented PSA data and the little imaging results that we saw in the FDG-PET and FDHT studies. So, we will be presenting more data but I'm really not at liberty to go into a lot more detail about what exactly that will be.

Michael Yee – RBC Capital Markets

Okay. On the Huntington's program, you've been saying you're going to complete in Q2. Do you think the actual release – the press release may fall into the third quarter's of what is possible?

David Hung

Yes, it is possible. We will release the results very shortly after we finish scrubbing all the data and going through the data analysis which will happen in the second quarter.

Michael Yee – RBC Capital Markets

But the release can actually fall in the third quarter?

David Hung

Yes.

Michael Yee – RBC Capital Markets

Okay and then last question, in terms of your 33% to 50% enrollment sites in the U.S. being – as you call that significant, do you have written or confirmed approval from the FDA that would fall under significant?

David Hung

I'll forward that question to Lynn.

Lynn Seely

As you know, the FDA will not decide that until the end of the study and they're actually looking at the data, but we do believe this represents the significant effort that they are looking for.

Michael Yee – RBC Capital Markets

Okay, great. Thanks guys.

Operator

Next we'll go to Ian Sanderson from Cowen and Company.

Ian Sanderson – Cowen and Co.

Yes. Thank you for taking the question. On the Alzheimer’s Phase III, have you disclosed the range of NMSC [ph] scores that are going to be use as enrollment criteria?

David Hung

I'll defer that to Lynn.

Lynn Seely

We'll be including an NMSC range of 10 to 24 inclusive.

Ian Sanderson – Cowen and Co.

Okay. So, that a little bit more, at least on the 10 side, a little bit more severe than what we've seen in most Alzheimer's drugs.

Lynn Seely

Of the currently approved Alzheimer’s drugs, that's a very standard mild to moderate NMSC range.

Ian Sanderson – Cowen and Co.

Okay. Thank you.

Operator

Next, we'll go to Kim Lee of Pacific Growth Equities.

Kim Lee – Pacific Growth Equities

Thanks. Two questions. First one regarding MDV 3100, what dose group are you up to now?

Lynn Seely

We have continued our dose escalation and to-date, the drug has been well tolerated. We're currently dosing the 360 milligram cohort.

Kim Lee – Pacific Growth Equities

Great. And no MTD yet?

Lynn Seely

No, there has not been an MTD yet.

Kim Lee – Pacific Growth Equities

Okay. Great. And second question, regarding the 18 months open label study in Alzheimer’s disease, what percentage of patients in the 12 months study actually entered the open label study and how many patients remain on drugs?

Lynn Seely

We haven't presented those data formally at this point in time, but I can just tell you that a good percentage are re-enrolled and continued on drugs.

Kim Lee – Pacific Growth Equities

Okay. A good percentage meaning like greater than 90%?

Lynn Seely

We can't comment until we actually present the data.

Kim Lee- Pacific Growth Equities

Okay. Great, thanks.

Operator

Next we'll go to Andrew Vaino of Roth Capital.

Andrew Vaino – Roth Capital

David, sorry, to hear about your voice, perhaps some hot tea with honey, drink it. Can you let me – the Phase I study of the Dimebon and the Aricept, where is that taking place?

David Hung

I'll defer that to Lynn.

Lynn Seely

That study's taking place in the U.S.

Andrew Vaino – Roth Capital

Okay, and total number of patients?

Lynn Seely

We haven't disclosed the details of that study, but it is a safety and tolerability study of Dimebon in patients who are stable on Aricept treatment.

Andrew Vaino – Roth Capital

Okay, and is the dose of the Dimebon 20 mgs?

Lynn Seely

Yes.

Andrew Vaino – Roth Capital

And what's the dose of Aricept ?

Lynn Seely

10 milligrams.

Andrew Vaino – Roth Capital

Okay, thank you.

Operator

Next we'll go to Raymond Myers of Emerging Growth Equities.

Raymond Myers – Emerging Growth Equities

Thank you for taking the questions. My question is related to MDV3100, and thinking forward to what would be required for approval in 3100, what do you expect the endpoint would be in a pivotal trial in prostate cancer?

David Hung

I'm going to defer that to Lynn as well.

Lynn Seely

We would anticipate that the primary end point would be overall survival. That being said, it certainly doesn't preclude us from looking at other innovative end points as well. But overall survival should be expected.

Raymond Myers – Emerging Growth Equities

What might some of those other end points be?

Lynn Seely

I think at this point in time, we prefer not to comment on that until we really have a better look at our overall data and complete the study, but we certainly will be looking at a number of considerations.

Raymond Myers – Emerging Growth Equities

All right. Greater graphic evidence I presume, functional imaging, I mean, we saw some of that. The reason I'm bringing it up, as we saw some of that already at the AACR, I think for the people who were there, it was a very exciting presentation. We all were excited to hear what we – to see what we hear and what you present at ASCO and I don't what to jump the gun too much, but if the data is as positive at ASCO as what seems to be foreshadowed by AACR presentations, then one would question what would be different about a pivotal study in prostate cancer that could not be answered by simply extending the Phase II study other than perhaps the number of patients?

Lynn Seely

I think at this point in time, it's really difficult to speculate on the ultimate outcome. I think what we're doing at this point in time is planning on the tried and true safety program of overall survival, while at the same time looking creatively at some additional things that we can do. Just – and I appreciate your comments, we are in the current trial looking at PSA clinical progression imaging and circulating tumor cells. So, there will be a large body of data from this trial that we will need to look at very carefully.

Raymond Myers – Emerging Growth Equities

Right. And survival, of course, will – is not a primary endpoint in a Phase II, but you'll get that eventually. In a Phase III, it will – certainly in this Phase II, there is no control group, correct?

Lynn Seely

That's right. But, the Phase III trial will need to be a placebo controlled trial.

Raymond Myers of Emerging Growth Equities

Well, then that brings up some – it might bring up some ethical considerations as to how one would design a placebo control in an end stage cancer population where there truly is no acceptable alternate therapy. If it is found that MDV3100 is reasonably efficacious or if it's believed that – if it's shown that it's reasonably efficacious in this Phase II study, will that affect how the design – whether a placebo control is ethical in a Phase III study?

Lynn Seely

Certainly, today the FDA and the regulatory authorities have been asking for a placebo controlled trial. So, we always will look at any way to move this program forward as expeditiously as possible, but at this point we're anticipating that placebo controlled Phase III trial.

Raymond Myers – Emerging Growth Equities

Okay. Great. Thank you.

Operator

(Operator instructions) We'll go to Bill Tanner from Leerink Swann.

Bill Tanner – Leerink Swann

Thanks. Maybe a question for you, Lynn. On the – looking at the press release from last summer when you guys presented one-year data, it looks like 120 patients in the Dimebon trial actually finished the 12 months, and it's not in the press release, I'm sure you guys talked about it. What would – do you recall what the breakout was in terms – of that 120, how many were Dimebon, how many were placebo?

David Hung

It was roughly half-and-half.

Bill Tanner – Leerink Swann

Okay, perfect. And then, Lynn, you mentioned that you got up to the 360 mg dosing course, you started at 60 and can – would the dose – the intervening dose is 60, 120, 180, 360?

Lynn Seely

So we started at – we did 30, 60, 120 – I'm sorry, 150 and 240, and now 360.

Bill Tanner – Leerink Swann

Okay. And can you – in how many patients per cohort, I know it was up to 20?

Lynn Seely

Yes. So we have – in the higher cohorts, we've expanded to 24 patients per cohort.

Will Tanner, Leerink Swann

The higher being?

Lynn Seely

Up 60 and above.

Bill Tanner – Leerink Swann

Okay. And is there any rough interval in between when the – were all the different dosing cohorts started at the same interval after the previous one?

Lynn Seely

So, what we need to do is make sure that as we dose escalate, we expose a small number of patients to the higher dose to ensure safety and we follow those patients for about six weeks to make sure that they are safe, and then we are able to expand that cohort. And so, as you know, the trial has been enrolling very rapidly.

Bill Tanner – Leerink Swann

Right. So, when you expand the cohort within – and then at what point in time do you start the next higher dose?

Lynn Seely

At the same time.

Bill Tanner – Leerink Swann

Okay. Got you.

Lynn Seely

So, while we're extending them, we can also dose escalate.

Bill Tanner – Leerink Swann

Okay. Okay, perfect. All right. Thank you.

Operator

Next we'll go Han Li of Stanford Group Company.

Han Li – Stanford Group Company

Hello, thanks. Two quick questions. One is on the Huntington's (inaudible) Phase II study, what should we expect in terms of the statistical power, is it power to show a difference for the Phase II?

Lynn Seely

So in the Huntington's disease trial, we intend to move this program forward aggressively, as we see an indication in that study that we're benefiting patients with this really severe disease. So, I would not say that if we are, of course, hoping for a statistical benefit. This is not an enormously large trial, so if we see a clear signal that we're benefiting patients, you'll see us moving forward aggressively.

Han Li – Stanford Group Company

Okay. And a quick question regarding the quite large credit.

David Hung

What was the question?

Han Li – Stanford Group Company

I'm sorry, the larger credit. What's the – you don't have any draw down in the first quarter, what's under the term of the contract, do you have to draw down the remaining $78.8 million by end of term?

Patrick Machado

No. It's entirely at our option, Han. We can take as much or as little as we like.

Han Li – Stanford Group Company

Okay. Thank you.

Operator

(Operator instructions). Next, we'll go to Kim Lee of Pacific Growth Equities.

Kim Lee – Pacific Growth Equities

Thanks. I have a follow-up question. When should we expect to hear more about the other mechanisms of action for Dimebon?

David Hung

We'll be presenting the mechanisms of action in an upcoming medical conference this year.

Kim Lee – Pacific Growth Equity

Okay. And can you go over what medical conferences you're going to be at this year?

David Hung

(inaudible) ASCO.

Kim Lee – Pacific Growth Equity

Right.

David Hung

That's all we'll disclose so far.

Kim Lee – Pacific Growth Equity

Okay. And the upcoming medical meeting for the mechanism of action, is that going to be Q3 or Q4 or the approximate timing of that?

David Hung

All we have said is it's going to be some time this year.

Kim Lee – Pacific Growth Equity

Okay. Thanks.

Operator

We will take a follow-up question from Bill Tanner of Leerink Swann.

Bill Tanner – Leerink Swann

Sorry. Just a real quick question for you, Lynn, in the 30 mg – 3100 dose cohort, how many patients were in there?

Lynn Seely

In that cohort, there were three patients. We didn't expand that cohort because the dose was low and we wanted to move up, and then as we began to see clear evidence that the drug was impacting PSA, we started expanding at that point.

Bill Tanner – Leerink Swann

In your – and the other dosing cohorts at 24 patients per ...

Lynn Seely

That's correct.

Bill Tanner – Leerink Swann

Okay. Thank you.

Operator

It appears that's all the time we have for questions. I would like to turn the conference back over to Dr. Hung for additional or closing remarks.

David Hung

I want to thank you all for participating in this call and look forward to seeing many of you at upcoming conferences and medical meetings. Thank you very much.

Operator

Ladies and gentlemen, that does conclude today's teleconference. We would like to thank you all for your participation and have a great day.

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