美國安進 (AMGN) 2006 Q1 法說會逐字稿

Good afternoon and welcome to the Onyx Pharmaceuticals first-quarter financial results.

My name is Mike, and I will be facilitating the audio portion of today's interactive broadcast. (Operator Instructions).

At this time, I would like to turn the show over to the Onyx Corporation.

Thank you.

Good afternoon.

I'm Julie Wood, Vice President of Investor Relations and Corporate Communications at Onyx Pharmaceuticals.

We thank you for joining us today for a general business update as well as to review our first-quarter 2006 financial results, which were released a bit earlier today.

Please note that this call, being held on May 4, 2006, is the property of Onyx Pharmaceuticals.

Any redistribution, retransmission or rebroadcast of the call in any form without the expressed written consent of Onyx Pharmaceuticals is strictly prohibited.

The order of our prepared remarks will be as follows.

After Hollings Renton, our CEO, makes some brief introductory remarks, Ed Kenney, our Chief Executive -- our Chief Vice President and Chief Business Officer, will talk about recent commercialization activities.

After Ed finishes, Hank Fuchs, our Executive Vice President and Chief Medical Officer, will provide a clinical update.

Next, Greg Schafer, our acting Chief Financial Officer, will discuss our first-quarter financial results.

Finally, Hollings will make closing comments and then open up the call for a discussion with management.

Please note that we will be making forward-looking statements during this teleconference that could include financial, clinical or commercial projections.

Statements that are not historical fact are forward looking.

References to what we expect, believe, intend to do, plan, estimate or other statements referring to future events or results are intended to identify these statements as forward looking.

Forward-looking statements are inherently subject to risks and uncertainties.

For a discussion of these risks and uncertainties, we refer you to our Annual Report on Form 10-K for the year ended December 31, 2005, specifically the section entitled Business Risk.

Also note that the forward-looking statements are based on our beliefs and assumptions as of today.

These beliefs and assumptions may change as a result of future events or the passage of time, which would cause these forward-looking statements to be outdated and no longer our view.

We undertake no duty to update these forward-looking statements.

I would now like to turn the call over to Hollings Renton.

Thank you, Julie.

We were very excited to begin 2006 with the first approved targeted agent for advanced kidney cancer and an experienced oncology field team that had just begun actively detailing physicians.

Working with Bayer, we achieved Nexavar net sales in the first quarter of $23.7 million.

We were able to accomplish this by moving quickly during the quarter to take advantage of having the first approved therapy for renal cancer patients in over a decade.

Our commercial team had expected and prepared extensively for Nexavar's approval, and this preparation resulted in Nexavar's impressive debut.

In fact, to capitalize on any first mover advantage afforded to us by early approval, we had the entire Bayer/Onyx sales team in place by the end of September 2005 and completed launch training during the fourth quarter of last year.

We also sponsored numerous medical education seminars, beginning as early as May 2005.

Finally and most importantly, we initiated a nation-wide expanded access program that allowed physicians and patients alike to gain important early experience with Nexavar.

It won't come as a surprise to anyone to say that we see the kidney cancer market as a very fluid space right now with two new drugs launching within weeks of each other, particularly after 13 years with no new approved therapeutics for these patients.

And we expect the market to continue to be dynamic as physicians gain experience with these new drugs.

As I commented earlier, we were very happy with the reaction to Nexavar's launch, which benefited from certain onetime events, including the conversion of expanded access patients and pent-up demand in the market as a result of previously-limited therapeutic options for these patients.

Many of the patients in this latter category were second or even third-line patients with very advanced disease.

We are pleased with Nexavar's first-quarter sales.

However, with two similar therapeutics entering the market at virtually the same time and with active experimentation by the physician community using this drug, it is too early to predict how this market will evolve.

Outside of the US, Nexavar has also been approved in Switzerland and Mexico.

In addition, the CHMP, Committee for Medicinal Products for Human Use, which is the body charged with reviewing and making recommendations to the European Union Commission issued a positive opinion regarding the Nexavar application.

As you know, in the EU, there is a system that provides for a centralized review of drug quality, efficacy, and safety.

Based on this positive recommendation, we continue to expect a decision on the European filing in the second half of the year.

Bayer and Onyx also have three pivotal trials underway in melanoma, liver, and lung cancers.

Yesterday, we announced the completion of enrollment in the melanoma and liver trials.

These potential registration studies reflect our strategy of expanding the use of Nexavar into other tumor types.

This is consistent with its broad mechanism of action, targeting both tumor cell proliferation and angiogenesis.

Except for the liver cancer trial, these studies all involve combinations with other anticancer agents, as Nexavar has been shown to be generally well-tolerated in a number of earlier-stage clinical trials when used with a range of other therapies.

Hank will say more about some of our ongoing studies during his comments.

Now, I will turn the call over to Ed to discuss our commercial activities in the quarter.

Thanks, Hollings.

As Hollings mentioned, in preparation for the US approval of Nexavar, Bayer and Onyx established an experienced team of sales and marketing specialists to facilitate adoption of the drug.

The team, as he mentioned, delivered 23.7 million in net sales for the first quarter and that was ordered by better than 1,800 different accounts.

That represents something like six times the number of sites participating in our pre-launch expanded access program, also known as [Arcs].

One of our key priorities was transitioning patients from that Rx program to commercial product.

This has been effectively completed with most of the expanded access patients now enrolled in REACH, our pharmacy and reimbursement support program, and with the majority of those patients now receiving commercial drug.

Remember, given where these patients were in their course of therapy, not all of them made the transition.

For those that did, we expect that their time on drug will be shorter than those of the new patients just starting Nexavar treatment.

Expanded access patients have now largely been switched over to commercial supply, and they will not be a significant source of new patients in the future.

The REACH program that I mentioned earlier is actually a cluster of support programs designed to benefit all patients, whether or not they were part of the expanded access trial.

While REACH is comprised of a complex set of activities, it has a single overriding purpose.

And that is maximizing patient access to Nexavar.

REACH counselors have been very busy working with patients and payers to confirm insurance coverage -- in the case of Medicare patients, helping them to sign up for Part D.

As widely reported in the media, Part D represented a national challenge and a major shift in healthcare reimbursement.

In fact, a number of states temporarily stepped in to assist patients as they sorted out their coverage options.

We were fortunate in that Nexavar per CMS guidance was to be automatically included in all formulary listings for Part D plans as a result of its approval in 2005.

Even with that advantage, the implementation of Part D at the beginning of this year was difficult for patients, companies and healthcare providers.

With the pending May 15 enrollment deadline, we expect Part D issues to remain challenging.

To help alleviate issues associated with Part D as well as with the time required for prior authorization on private payer plans in cases where it took more than a few days to determine insurance coverage, Bayer and Onyx provided patients with a temporary supply of product at no charge.

This substantial donation of free drug was done to ensure that patients had access to important new therapy.

As we have commented previously, Nexavar is covered by the majority of managed healthcare plans, including the top 35 plans.

The majority of plans do not require coinsurance and have monthly co-pays of $50 or less.

Although there has been good progress in establishing broad reimbursement for Nexavar, lack of Part D signups and the prior authorization requests could lead to some amount of ongoing free goods, while REACH helps patients get coverage.

Bayer and Onyx have a closed distribution system, utilizing a small number of specialty distributors in the US.

These distributors supply product directly to the patient and in some cases to hospitals and physicians' groups.

This small network allows us to optimize patient care, while limiting inventory build in the channel to modest levels.

I might add for the use of you receiving information on Nexavar sales through third-party databases, I want to caution you that our distributor contracts specify that data cannot be released to any third party.

Therefore, those sources are not reliable.

In regard to territories, as Hollings mentioned, outside the US, we received Swiss approval in the first quarter, approval in Mexico last month and have applications pending in the European Union as well as in other countries.

Based on recent positive opinion regarding our dossier in Europe, we continue to anticipate an action in the EU in the second half of the year.

With that timeframe in mind, Bayer has been actively staffing their sales and marketing teams in Europe and in many other territories worldwide.

With two new drugs entering the renal market almost simultaneously, a market without a new approved therapeutic in over a decade, we're seeing conventional treatment practices changed markedly.

Although we have seen prescribers move away from traditional treatments in favor of newer targeted agents like -- excuse me -- already we have seen prescribers move away from traditional treatments in favor of newer targeted agents, like Nexavar.

This market shift is a work in progress and will need to sort itself out.

We will of course continue to provide product and market details to the financial community over the coming months.

I would like now to turn the call over to Hank Fuchs to talk about our clinical program.

Thank you, Ed.

As Ed said, this is an exciting time for Onyx and Bayer, an important time for patients.

We're pleased that Nexavar is making a difference for patients with kidney cancer, and we look forward to generating data in other tumor types, such as melanoma, liver, and lung cancers.

Nexavar is the only drug shown to prolong progression-free survival in a randomized study of patients with advanced renal cell cancer.

At the time of the plan survival analysis based on 220 deaths, overall survival was longer for patients treated with Nexavar than with placebo with a hazard ratio Nexavar over placebo of 0.72.

This analysis did not meet the pre-specified criteria for statistical significance, since the protocol specified a p-value of less than 0.0005 to stop the clinical trial early.

At the time of the analysis, the median survival for patients on placebo was 14.7 months, while the median survival for Nexavar had not yet been reached.

A second analysis of survival has now been completed, and we intend to report that result at ASCO, the American Society of Clinical Oncology, next month.

This analysis will include patients that "crossed over" from placebo treatment to treatment with Nexavar as well as an analysis of those patients who did not cross over.

In addition to Nexavar's efficacy, the drug was generally well-tolerated in the Phase III study, with a discontinuation rate for Nexavar of 10% as compared to 8% for those receiving placebo.

Drug-related adverse events of all grades were similar to what had been observed in previous clinical trials and included rash, diarrhea, hand-foot syndrome, hair loss, itching, nausea, hypertension and fatigue.

For detailed information about Nexavar including important safety information, please refer to the package insert, which can be accessed at www.Nexavar.com.

As we've mentioned earlier, a regulatory application for the treatment of patients with advanced kidney cancer has been filed in Europe.

And the Committee for Human Medicinal Products has completed their review of the application and made a positive recommendation to the EU Commission.

We continue to expect the regulatory action in European Union in the second half of the year.

There is also an expanded access program underway in Europe, similar to what was done in the United States, in more than 10 countries.

Regulatory applications are also on file in Australia, Brazil, Canada, Turkey and other territories internationally.

We also have plans to study Nexavar in the adjuvant setting of kidney cancer.

This would be treating patients after surgical removal of their diseased kidney.

Such patients might have microscopic residual disease and be at risk for recurrence of their kidney cancer.

Two studies are planned, one in the United States and one in Europe.

The US study, under the auspices of a cooperative group, is just opening.

Given the endpoint in adjuvant studies, these generally take several years to complete.

As Hollings mentioned, Bayer and Onyx are also completing -- are sponsoring pivotal trials in advanced liver cancer, metastatic melanoma and lung cancer.

In liver cancer, we're conducting an international placebo-controlled Phase III trial evaluating Nexavar as a single agent.

We have recently completed an enrollment of approximately 600 first-line patients.

These advanced patients are all [child pew a] status with good ECOG performance scores.

The co-primary endpoints of the study are overall survival or time to symptom progression.

While there is a planned interim analysis based on a secondary endpoint of time to disease progression, we expect the trial to continue to its final analysis.

While the study is moving rapidly, we're not estimating when the trial will be complete -- the data analyzed -- as it is an event-driven analysis.

In metastatic melanoma, there are two ongoing Phase III studies comparing the administration of Nexavar in combination with the chemotherapeutics, carboplatin and paclitaxel, to treatment with chemotherapy alone.

In one study sponsored by the Company, more than 250 previously-treated patients have been enrolled to assess a primary endpoint of progression-free survival.

The other study sponsored by the Eastern Cooperative Oncology Group, or ECOG, will enroll about 800 first-line patients and measure differences in overall survival.

While we have completed enrollment in the Company-sponsored study, it is premature to estimate when the number of events will be reached and the analysis completed.

If the results from this study are positive, the trial could serve as a basis for regulatory application in many territories around the world.

During the first quarter, Bayer and Onyx also announced the initiation of a Phase III trial in patients with non-small cell lung cancer.

In this study, approximately 900 first-line patients will receive Nexavar in combination with standard chemotherapeutics agents.

This study, which is being conducted internationally, will enroll all types of non-small cell lung cancer patients.

Though, given the experience with other antiangiogenic agents, we will do frequent monitoring on the population of patients, who have squamous cell carcinoma.

Over the last 12 months, we demonstrated that Nexavar was an active drug and commercialized it for patients suffering from advanced kidney cancer.

Over the next 12 months and beyond, we hope to demonstrate Nexavar's effectiveness in other tumor types.

While we have trials underway in melanoma, liver and lung cancers, we believe that Nexavar's broad mechanism of action makes it potentially applicable to an even wider range of tumor types.

In this regard, Bayer and Onyx share a commitment to fully invest in and explore the potential of this exciting new drug on behalf of patients with cancer.

I will now turn the call over to Greg.

Thanks, Hank.

The launch of Nexavar represents a major milestone for Onyx and for our collaboration with Bayer.

Nexavar's progress from research through development and now to commercialization requires that we change the way we present the Onyx income statement.

In the new presentation, the net expense from the unconsolidated joint business is reflected in a single line item in the expense section of our P&L.

This line item, which takes into account Nexavar revenue and all shared expenses, represents a net balancing payment due to Bayer from Onyx to equalize Nexavar's contribution between the two companies.

Upon profitability, this line item will appear as revenue on our statement of operations and will represent the net balancing payment from Bayer to Onyx.

Net expense from the unconsolidated joint business is derived by subtracting total share expenses as well as any contractual adjustments under the collaboration from the revenue generated by the sale of Nexavar and dividing by two.

We then add back Onyx's direct expenses relating to the collaboration.

For the current quarter, the result is a net amount of $4.1 million due from Bayer -- due to Bayer from Onyx to equalize third parties' net expenses or losses under the collaboration.

Onyx's direct Nexavar expenses are included with our other direct expenses in the R&D and SG&A line items in the income statement.

An additional change to our income statement presentation is the inclusion of employee stock-based compensation expense as required by FAS 123R.

I will talk more about this in a moment.

For the three months ended March 31, 2006, Onyx reported a net loss of 20.4 million or $0.49 per share.

Excluding the stock-based compensation expense, our net loss was $16.7 million or $0.40 per share.

Turning to a review of the statement of operations, I want to remind listeners that Bayer records all Nexavar revenue.

As such, Onyx reported no revenue for the first quarter of 2006.

Bayer however recorded net sales for Nexavar of $23.7 million for the first quarter.

In the first quarter of last year, Onyx recorded revenue of $1 million.

This reflected a non-refundable payment from Shanghai Sunway for exclusive rights to license certain Onyx patents from the therapeutic virus program, which Onyx discontinued in 2003.

Total share development expenses under the collaboration were $30 million for the first quarter of 2006, an increase over the same period in the prior year due to an increased number of clinical studies, including the pivotal Phase III trials in melanoma, liver cancer, and lung cancer.

We also have a significant number of regulatory initiatives underway to support Nexavar filings in Europe and the rest of the world.

As a result, we anticipate that 2006 development expenses for Nexavar will be higher than in 2005 due to the increased level of clinical and regulatory activity.

Nexavar's sales and marketing expenses incurred by Bayer and Onyx, including the cost of goods sold and distribution expense, were $17.7 million for the first quarter of 2006, a significant increase over the first quarter of 2005.

This increase was the result of the sales and marketing activities surrounding the launch of Nexavar in the US and the pre-launch activities in Europe that Ed mentioned.

We expect Nexavar's SG&A expense will increase through 2006 and be significantly higher than in 2005, given the costs associated with building the rest of the world's sales and marketing organizations and associated pre-launch activities, including the potential for an earlier-than-anticipated launch in Europe.

Onyx's direct SG&A includes the cost of its US sales force, a small amount of Nexavar marketing expense and the general and administrative support for the Company.

With respect to 123R, total stock-based compensation expense for the first quarter was 3.6 million or $0.09 per share.

Approximately $700,000 of this is in the R&D line item, and $2.8 million is in the SG&A line item.

At March 31, 2006, we had cash, cash equivalents and marketable securities of $258.3 million as compared to $284.7 million at the end of 2005.

Included in this number is the final creditable milestone payment received from Bayer during the first quarter in the amount of $10 million.

The milestones, totaling $40 million in all, will be repaid to Bayer from part of our share of any profits under the collaboration.

These payments, when made, will not flow through the P&L.

Now, I will turn the call back over to Hollings.

Thanks, Greg.

We are extremely pleased with Nexavar's strong start.

In the first quarter, approximately 24 million in net sales were generated from more than 1,800 accounts.

Also, during the first quarter, we made a number of important observations.

First, Nexavar's rapid uptake was driven in part by pent-up demand.

Without a new therapeutic approved in over a decade, there were a number of late-stage patients anxious for a fresh treatment option.

We believe that many of these early patients had late-stage disease and may not be representative of the patient population in general.

Second, we shipped more free goods than we had originally planned, as our focus was on providing kidney cancer patients access to Nexavar.

The amount of free goods was due to a combination of factors, including the time needed to convert the expanded access patients, the Medicare Part D signup issues, and the time involved in getting authorization from commercial payers.

We see some of these factors influencing future periods.

For example, potential Medicare patients, who don't signup for Part D before the mid-May deadline, may consequently have limited reimbursement coverage.

Third, given Nexavar's early availability through Arcs and our strong first-quarter performance in first-line patients, we helped create a second-line opportunity for other agents that the competition moved to capture, facilitating their uptake.

With these factors and other critical variables still unknown, making projections about future performance is impossible at this point.

For example, days on therapy.

We're tracking the Arcs patients and monitoring first-quarter data.

But, we anticipate that the early numbers may be skewed by the type of patients, who came on drug just after launch.

We're also collecting data on compliance and dosing to monitor how patients and doctors are utilizing Nexavar.

As we amass data on market trends, we are also studying how physicians are sequencing these new drugs.

It is a competitive market, and our joint field team is continuing to educate physicians and caregivers as we expand our US and sales and marketing efforts.

In addition, outside of the US, Bayer is preparing for product launches -- and again, as mentioned earlier, launches that are earlier than we had expected given the rate of activities with the European Commission.

We're focusing on clinical trials underway also to gain approval in indications beyond kidney cancer.

Nexavar is a unique molecule, and kidney cancer is just the beginning of a broad development program to explore its utility in both unmet diseases as well as in common malignancies.

It is a convenient oral medication that is generally well-tolerated with mild-to-moderate side effects.

Nexavar has already shown single agent activity in a difficult tumor type, and it has shown in early clinical studies potential combinability with other anticancer agents.

We do believe that Nexavar may change the way cancer is treated.

Thank you for your time.

We would now be happy to take questions.

Mike, do you want to go ahead and open it up for Q&A?

(Operator Instructions).

David Witzke.

I wonder, is it possible to give monthly breakout of sales, January February and March?

No, we're only providing quarterly data.

We don't think that it's too early to actually look at monthly trends.

And, given the newness of the mark to the market, that monthly data may be not that meaningful.

All right.

Can you say that sales increased each month?

Again, we haven't broken out the detail.

But, again, the activity has continued to pick up during that quarter.

Regarding the rapid enrollment of the ACC in melanoma-based Phase III studies, is it possible now to see data earlier than anticipated?

How should we think about timeline on both of those?

Well, I think that we were quite pleased with the pace at which we had been able to enroll the patients on both of those studies.

And it is ahead of even some of our internal projections.

But, I think that we would rather not get into forecasting timing of data out of the studies, given the dependence on the rate at which the events occur as well as obviously making sure that we allow ourselves plenty of time to get all the data and clean it up and then do the analysis.

But, we are -- we do believe that we are ahead of the original schedules.

David Bouchey, RBC Capital Markets.

Congratulations on the quarter, guys.

Listen, there is still -- if you look at the IMS weekly prescription data, there still appear to be some centers where some data is coming from.

Can you give us some kind of an idea about where that data is actually coming from and what the perils might be for using that as a predictor for sales trends?

Most of the distribution occurs through distributors, where we have indicated that they should not distribute the data.

Some of it goes through hospital sources.

It may end up in pharmacies that we can't tightly control.

So, as much as we have tried to control that -- and again, it is looking largely for competitive reasons that we're trying to do that -- but, there is still some leakage [move].

That's why we do want to caution everybody that when you see the IMS data -- is no way a reflection of what's happening with Nexavar.

And again, that was -- as we had said earlier, for competitive reasons, we're able to get a pretty good track on where the competition's drug is going based on their reporting.

My last question is, you had mentioned you're going to have some second analysis of survival from the renal cell Phase III at ASCO.

Is this the final analysis, or is it something in between the first analysis and the final analysis?

It's not the final analysis then as you say.

It's the number of events that's between the 220 events on the analysis that occurred in November and the planned final analysis of 540 events.

Howard Liang, Leerink.

So, can you give us the channel stocking number?

We haven't broken that out.

I think what we've generally said is it's relatively modest stock in compared to other drugs because of the tight distribution system and the ability of Bayer to distribute pretty quickly to those distributors.

Okay, can you say when will you be able to convert most of the patients on EAP?

The majority of them have been converted.

There are a few that have not been, but the majority have been converted as Ed had said.

But, was it during the middle of the quarter or was it--?

Well, it's quite variable.

As you recall, the EAP was actually an FDA-approved protocol at clinical trial that required IRBs and everything else.

And because it was a protocol, although we encourage people to enroll in REACH, not all of that was done in a timely fashion.

So, it did take a little while to get them converted.

But, I think we've got most of them -- the majority of them converted at this stage.

What about the makeup of your patients?

Are they first timers and second line?

Again, we do track that information.

We do look and think that we are getting the majority of the share in the first line.

As I alluded to in my comments at the end, both the Arcs expanded access program, which had a significant percentage of those patients being first-line patients -- obviously over time, those patients come off and create second-line opportunities for the competitors there.

So, I would think you would expect that a lot of the demand there is coming from second-line patients being created after treatment with Nexavar.

(Operator Instructions).

Gene Mack, HSBC Securities.

Just to be clear, the majority of the use that you are seeing right now is in front line, is that fair to say?

I'm not sure that I could say that.

We have more market share than competitors in that from all the sources that we're looking at.

We are getting usage in the second line, but we do have more first-line patients than the second line on a new basis, yes.

Are you seeing at least anecdotal use with just about every agent?

Are you seeing some combination with Avastin and maybe IL-2 as well with other agents?

Or is it--?

You know, I haven't seen -- Ed, have you seen any data --

No, actually we're not.

Most of what we're seeing is in most of the uses -- overwhelming majority of uses in the indicated disease.

It is pretty much as the package label indicates, the dose and the schedule.

And the single agent nature of that is in line with the label.

Just a question about something I saw at AACR, it looked as though on one of the billboards you folks had up that a [c-tap] second-line breast cancer trial might be coming to completion.

Is that something that maybe you presented before?

Is it something we might see data from in the near-term?

Hank, do you have any updates on that or in general on investigator-sponsored studies?

Yes, we aren't in a position to talk about c-tap studies might get presented and when they might get presented.

The one thing I would say, just leading up to ASCO, more -- the majority -- there were more studies -- actually abstracts submitted from independent investigators and from company-sponsored.

So, it's a very large program that, as Hank says, we don't have as much control over.

We learn of these things as the data is being generated.

The other thing I guess I would note just to let you know is that if you haven't looked on the ASCO Web site, the abstracts for Nexavar are listed there.

And Julie, I believe you put them up on our Web site, is that correct?

Yes, they are up on our Web site.

Then, I'm going to have to ask the dumb math questions now.

I know you're saying that R&D -- it looks like R&D is going to go up I guess when you net everything out -- everything that's going into the joint business, the unconsolidated joint business and what you're actually recording.

But, in terms of what you're actually just recording on your side of the P&L if I can put it that way, the R&D total seems to actually be drifting.

It seems to be coming down.

Is that right to say?

Well, it's actually -- you can't tell that on the face of the P&L here.

So, the actual if you actually were to go about using the supplemental table and combining it with what's listed from our R&D site, the combined amount -- our 50% share of the combined amount actually goes up quarter over quarter.

What I would suggest would be that both you and any other person who is running models, if you wanted a little bit more education about how to kind of put this on a comparable basis looking at the old methods to give Julie and Greg Schafer a call.

They can kind of walk you through it.

But, it's obviously confusing to look at two formats here, and we would be happy to help you off-line.

Yes, it seems to be standard operating procedures.

So, thanks, I appreciate that.

I will do that.

Brian Rye, Janney Montgomery.

Congratulations on a good start.

It's probably a bit early to ask this question.

But, I wonder if you have any data or anecdotal evidence, either from the expanded access program or the commercial launch itself regarding duration of treatment in the marketplace and how that compares to data generated in the pivotal studies.

Yes, I think you answered your question.

It is too early for us to really have any reliable data.

And, even in this first quarter in the marketplace, our sense is that some of these newer patients include some second line and third line at a higher percentage than we might see over time and a little bit later stage.

So I think that we're going to have to continue to track that.

The first -- and stick with what we have indicated as guidance thus far, which is the only data that is reliable at this stage, is the meeting PFS out of our Phase III study of six months.

So, I think we can't really provide an update against that yet.

We are tracking these Arcs patients -- would be the next cohort of patients that we could try to generate some additional data on recognizing that is still a clinical protocol.

And then, the real key question is what does happen in the marketplace, not on clinical protocol and with alternate agents available.

There are no further questions.

Are there any closing remarks?

Okay, no other questions?

Well, number one, we appreciate everybody signing on, listening to our first report of financial results with the revenues.

And we're pleased with the start.

It's early days.

There's a lot of forces at work.

We are pushing very aggressively, not only in renal cell but in extending the use to other types of tumors.

So, again, stay tuned, and we will talk to you next quarter.

Thanks.

This concludes the Onyx Pharmaceuticals first-quarter financial results conference call.

You may now disconnect.