Seagen Inc (SGEN) 2008 Q1 法說會逐字稿

Good afternoon, ladies and gentlemen, and welcome to the first quarter 2008 financial results conference call.

(OPERATOR INSTRUCTIONS)

This conference is being recorded today, Thursday, April 24, 2008.

And I would now like to turn the conference over to Peggy Pinkston, Director of Corporate Communications. Please go ahead, ma'am.

Thank you.

I'd like to welcome all of you to Seattle Genetics' first quarter 2008 conference call. With me today are Clay Siegall, President and Chief Executive Officer; Todd Simpson, Chief Financial Officer; Eric Dobmeier, Chief Business Officer; and Tom Reynolds, Chief Medical Officer.

Today's conference call will include forward-looking statements based on current expectations. Such statements are only predictions, and actual results may vary materially from those projected. Please refer to the documents that we file from time to time with the SEC and which are available on our website for information concerning the factors that could affect the Company.

I'll now turn the call over to Clay.

Thanks, Peg, and thank you all for joining us this afternoon. Today I'll give an update on the substantial progress we're making with our programs as well as provide an overview of planned activities. Then Todd will go over the financial details for the first quarter of 2008, after which we'll open the line for questions.

So far in 2008 we advanced and expanded our product pipeline through initiation of four new clinical trials, with SGN-40, SGN-33 and SGN-35. We now have 10 trials ongoing across our portfolio and two more planned to start this year. We reported preclinical data at the American Association of Immunology's annual meeting earlier this month, reporting the clinical trial with SGN-70 we plan to initiate for autoimmune disease later this year. We made multiple presentations of preclinical data at the American Association for Cancer Research annual meeting last week, demonstrating advancements in our ADC technology and SGN-33 program. And we completed a financing in January, generating net proceeds of $97.6 million. That puts us in a strong position to continue advancing our pipeline.

Our clinical programs have each generated encouraging single agent objective responses that demonstrate their therapeutic potential for patients with cancer, supporting our aggressive development plan. In the near term, we look forward to presenting more data on SGN-35 at the American Society of Clinical Oncology annual meeting in early June. Our data from this ADC program demonstrates potent antitumor activity of SGN-35 as a treatment for Hodgkin lymphoma and further increases our enthusiasm for our ADC technology's ability to empower antibodies. We also expect to report data from multiple clinical programs later this year at appropriate medical conferences, including ASH.

I'll begin with an overview of SGN-40, a humanized antibody that we are developing under a worldwide collaboration agreement with Genentech. Five of the six planned clinical trials under the collaboration are underway, and we expect that the sixth trial will be initiated this quarter. Our joint clinical development program is designed to assess the potential of SGN-40 for non-Hodgkin lymphoma in multiple myeloma, both as a single agent and in combination with standard treatment regimens.

During the first quarter, one of our SGN-40 trial initiations triggered a $4 million milestone payment. This brings the total amount we have received thus far from Genentech under the deal to approximately $100 million, including the upfront payment, the milestones and reimbursements. We are executing on a broad SGN-40 clinical program, including a Phase II single agent study in relapsed or refractory diffuse large B-cell lymphoma and a Phase IIb randomized double-blind placebo-controlled trial of Rituxan and ICE plus or minus SGN-40. We have 220 second line diffuse large B-cell lymphoma patients.

The clinical program also includes four Phase Ib trials, three of which are ongoing, to evaluate SGN-40 in combination for non-Hodgkin lymphoma and multiple myeloma. We expect to initiate a Phase Ib trial of SGN-40 plus Velcade in relapsed or refractory multiple myeloma later this quarter. In June, final data from our Phase I single agent clinical trial of SGN-40 in relapsed or refractory non-Hodgkin lymphoma will be reported in an oral presentation at the International Conference on Malignant Lymphoma being held in Lugano, Switzerland. The presentation will summarize complete findings from the trial, including antitumor activity and tolerability.

At the Genentech investment community meeting in March, data were shown describing a potential gene signature that may help identify lymphoma patients most likely to respond to SGN-40 monotherapy. Evaluation of this novel tool is planned in both our single agent and combination trials of SGN-40 for lymphoma. This is an exciting area of research and an example of the way Genentech's expertise and resources are enhancing development of this program. Our SGN-40 development plan continues on track, and we believe this antibody will play an important future role in the treatment of patients with cancer.

Next is SGN-33, or lintuzumab, a humanized antibody that we are developing for acute myeloid leukemia, or AML, and myelodysplastic syndrome, or MDS. Based on promising data from a Phase Ia dose escalation trial, which were presented at ASH last December, we are conducting a Phase Ib study to further evaluate the single agent activity of SGN-33 for AML and MDS. We expect to complete patient accrual in the trial this year, and to report data in the second half of 2008.

We are also evaluating SGN-33 in a randomized Phase IIb study of low-dose cytarabine plus or minus SGN-33. This trial will accrue approximately 210 AML patients 60 years of age or older. Treatment with low-dose cytarabine alone has been shown to result in a median overall survival of less than six months for older AML patients. By leveraging the tolerability and antitumor activity of SGN-33, we hope to extend overall survival in this patient population, where the prognosis is poor and treatment options are limited.

The third ongoing clinical trial with SGN-33 is our recently initiated Phase I study in combination with Revlimid for advanced MDS. This study of approximately 30 patients is being conducted under a research agreement with Celgene, through which they are supplying Revlimid. Preclinical data suggests that Revlimid can augment effector function, an important mechanism of action for SGN-33, making this combination particularly compelling.

Complementing our registration strategy for older AML, we are currently developing our plans for SGN-33 in younger AML patients. We believe that SGN-33 has application both combined with chemotherapy to improve relapse-free survival and as a monotherapy to maintain remission after conventional chemotherapy or stem cell transplants. We are also continuing to investigate SGN-33 in preclinical models. In particular, we reported data during AACR earlier this month describing the ability of SGN-33 to increase survival in multidrug-resistant models of AML that are resistant to chemotherapy. We are enthusiastic about the potential of SGN-33 and will keep you updated on our progress during 2008.

I'll move on now to SGN-35, our antibody-drug conjugate, or ADC, that is in Phase I clinical trials in patients with Hodgkin lymphoma or CD30-positive T-cell lymphoma. In November 2007 we reported interim Phase I data showing measurable reductions in tumor volume in more than 75% of patients, including four objective responses. We will report additional objective responses as well as durability of these responses at ASCO in early June.

We believe our data support aggressive advancement of this program and are increasing our investment in its development. Todd will provide an overview of how this will impact our financial guidance. In particular, we recently contracted with Abbott Labs for manufacture of the antibody component of SGN-35. This manufacturing campaign will provide drug supply for later stage clinical trials. We are currently refining our clinical development pathway, including registration strategy, and expect to detail these plans in the second half of 2008.

To further explore the potential of our ADC technology, we recently initiated a second Phase I trial of SGN-35 to assess weekly dosing as compared to the every-three-week schedule used in our first Phase I trial. The study will also evaluate SGN-35 in combination with Gemzar, a drug often used in the treatment of relapsed Hodgkin lymphoma. Relapsed and refractory Hodgkin lymphoma represent a serious unmet medical need. Although front line therapy can achieve cures or long-term remissions, a significant number of patients relapse and require additional treatment, including stem cell transplants and other chemotherapy regimens.

Our market research indicates that there are several thousand newly relapsed or refractory lymphoma patients in the U.S. each year who would be eligible for treatment with SGN-35. U.S. (inaudible) is more than 10,000 patients, and there's roughly the same number in Europe. Based on our projections, this translates into worldwide annual (inaudible) sales potential for SGN-35 in the relapsed or refractory setting of $300 million to $400 million. We believe that data to be presented at ASCO will provide evidence of the potential of SGN-35 for Hodgkin lymphoma as well as further validation of our ADC technology.

The next product candidate we plan to advance into clinical trials is SGN-70, a humanized antibody targeting the CD70 antigen. At the AAI meeting earlier this month, we reported preclinical data describing the expression of CD70 on activated but not resting T- and B-cells and in autoimmune disease tissues. The data also demonstrated that SGN-70 inhibits T- and B-cell function and selectively depletes CD70-positive activated T-cells. We plan to bring clinical trials -- we plan to begin clinical trials with this antibody in the second half of 2008.

Driving our future pipeline growth are three ADCs in preclinical development. SGN-75, for CD70-positive hematologic malignancies and solid tumors, and anti-CD19 ADC for hematologic malignancies, and AGS-5 ADC for solid tumors, which we are developing in collaboration with Agensys, now a subsidiary of Astellas. Seattle Genetics researchers recently presented data in multiple poster presentations at AACR highlighting our ADC technology, including preclinical data on SGN-75.

Our ADC collaborators are also making strong progress. Earlier this month, CuraGen advanced its CR011 ADC into a Phase II clinical trial, triggering a milestone payment to us. And preclinical findings were presented at AACR by some of our ADC collaborators, including a presentation by Progenics on their PSMA-targeted ADC. Our SGN-35 clinical data bolster our excitement for the potential for ADCs to significantly impact the way cancer is treated, and we are committed to enhancing our leadership position in this growing field.

We expect to achieve significant milestones over the remainder of 2008. These include, for SGN-40, we and Genentech will initiate one more clinical trial, for a total of six ongoing trials in non-Hodgkin lymphoma and multiple myeloma, and we will report final Phase I data from our non-Hodgkin lymphoma study in June. For SGN-33, we expect to report data from the Phase I single agent trial later this year, while also advancing the randomized Phase IIb low-dose cytarabine study in AML and the Phase I Revlimid combination trial in MDS.

For SGN-35, we will report multiple additional objective responses from the ongoing Phase I trial at ASCO and provide our development and regulatory strategy later this year. For SGN-70, we plan to initiate a Phase I trial for autoimmune disease. And we expect to report additional clinical data on SGN-40, SGN-33 and SGN-35 in the second half of the year, most likely at ASH in December.

Now I'll turn the call over to Todd to discuss financial results.

All right. Thanks, Clay, and thanks, everyone, for joining in on the call this afternoon.

I'll start off today by saying that our growth momentum coming out of 2007 continued in 2008. As expected, our first quarter 2008 financial results reflect increases in both our top line revenues and in our expenses resulting from the expanded activities in our pipeline that Clay described.

Revenues in the first quarter of 2008 were $7.1 million, 65% higher than revenues in the first quarter of 2007. These revenues primarily reflect amounts earned under our SGN-40 collaboration with Genentech, which was signed in January 2007 and has been building momentum since. During the first quarter of 2008, we also achieved a $4 million milestone, triggered by one of the SGN-40 clinical trial initiations, a portion of which is included in our Q1 revenue. As a reminder, all payments received from Genentech, including reimbursements, the $60 million upfront payment and now $20 million in milestones received so far, are recorded in revenue over the six-year development period of the collaboration.

Operating expenses increased in the first quarter of 2008 to $26.1 million, compared to $14.6 million in the first quarter of last year. This reflects higher R&D expenses, which were $22.2 million in 2008 compared to $11.8 million in 2007. The principle drivers of these increases were expanded clinical development and manufacturing activities. In particular, SGN-40 manufacturing expenses were up during the quarter, reflecting campaigns to support ongoing and planned clinical trials by us and Genentech.

Additionally, clinical development expenses for SGN-40, SGN-33 and SGN-35 increased, reflecting the substantial clinical trial activities now underway, including global Phase II clinical trials of both SGN-40 and SGN-33. And lastly, employee cost also increased, primarily driven by growth in our clinical and development groups. This includes non-cash share-based compensation expense for the first quarter of 2008 of $2.2 million, compared to $1.4 million in the first quarter of 2007. As a reminder, SGN-40 collaboration costs, including all of the manufacturing and clinical costs I mentioned, are included in our expenses but are reimbursed by Genentech under the collaboration.

Driven by our positive clinical momentum, we are increasing the investment in manufacturing and development activities necessary to move our programs forward rapidly. We recently contracted with Abbott Laboratories for additional manufacturing of the antibody component of SGN-35. This is part of our strategy to prepare for later stage clinical studies and to ensure that drug supply is available for this program. And, as Clay said, we look forward to sharing our SGN-35 clinical development pathway, including our registration strategy, in the second half of 2008. During 2008 we also expect some additional investment in SGN-40 manufacturing to support the multiple and planned ongoing clinical trials by us and Genentech.

Based on these and other planned activities across our product pipeline, we are increasing our financial guidance for 2008 as follows. Operating expenses should now be in the range of $125 million to $140 million. Cash used to fund operating activities should now be in the range of $75 million to $85 million, and revenues should now be in the range of $30 million to $33 million. And lastly, from a cash standpoint we ended the first quarter of 2008 in our strongest ever financial position, with approximately $216 million in cash and investments to fund our development activities. Factoring in the increased investment in our programs that I mentioned, we expect to end 2008 with more than $140 million in cash and investments.

And with that I'll turn the call back over to Clay.

Thanks, Todd.

Operator, at this point we'd like to open the call for questions.

Thank you.

(OPERATOR INSTRUCTIONS)

Our first question comes from the line of Glen Gechlik. Please go ahead, from Needham & Co.

Hi, good afternoon. Congratulations on progress with all of your programs. I had a question about SGN-33 and the AML program. In the elderly AML trial, when do you think enrollment will complete, and how is that going?

This is Clay. The elderly AML trial is going very well, and we haven't given a lot of specifics on that at this point. But I'll turn it over to Tom Reynolds, Chief Medical Officer, to try to address maybe some of your comments or questions.

Yes, this is Tom Reynolds. I think the trial you're talking about is our Phase II randomized double-blind placebo-controlled ara-C study. Right now it's accruing very well. We have a large number of sites open internationally. Patient enrollment is good, and we are on target. Our guidance that we have given is that we would be able to be disclosing data around the end of 2009. It's an event-based trial, in terms of database locked and unblinding. So part of it depends on how many patients -- how long patients survive, and that'll drive really when the trial is actually unblinded. But currently our projections are the end of 2009.

Thank you very much for answering that question. Just another quick question. I know you're excited about the anti-CD9 (sic) ADC. Is there anything particular that excites you about it?

Yes. I think our preclinical data with our anti-CD19 ADC is very exciting. We've reported some of it, not all of it. And I think that based on our preclinical data in model systems, based on pilot toxicology studies and based on the exciting activity we're seeing in SGN-35 that we'll be reporting at ASCO, we think our anti-CD19 ADC is a pretty darn good product.

Well, thank you for answering all my questions. I want to wish you congratulations again on advancement of your pipeline and your progress.

Thank you. Our next question comes from the line of David Miller, from Biotech Stock Research. Please go ahead.

Hi, great. Thanks for taking my call. You talked about a potential gene marker to be used in combination with SGN-40. Can you tell me a little bit about that, including what kind of percentage of patients that you could -- percentage of target population might have this genetic marker and a little bit about the mechanisms that you suspect?

David, it's actually a gene signature, so it's composed of a set of genes. It's not a single gene marker.

Okay.

It's a set of genes. And this has been discussed by Genentech, and at this point it's not been reported to any great extent. Tom, do you want to comment further on that?

Yes, Genentech has done a lot of work both with cell line and now with patient samples to try to identify a predictive gene signature with a series of genes that might allow us to use prospective stratification or enrollment of patients in future studies. They have shared some of the data with us. It's still developing. And our expectation is they'll report that out publicly probably somewhere toward the end of this year or early next year. So we're looking forward to seeing more data here and being able to share it with you publicly.

So you don't have any idea yet what percentage of patients this would be, of the total population?

We really can't disclose anything about that.

Okay. I understand. Their program. Fair enough. The second question I have is actually for Todd, is can you talk a little bit about the status of or the existence of any cash impairment that you might have from some of the investments of your cash balance?

Yes, the simple answer is we don't have any impairment issues with our cash. We do have a relatively small portion of the portfolio in a couple of auction rate securities, but these are pretty dramatically different than I think some of the securities in other companies' portfolios that have taken big write-downs. These are not subprime-backed securities. They're all AAA-rated pieces of paper. They are paying interest currently. We're comfortable that, while temporarily there's a liquidity issue, there's not a credit or a quality issue, and given that it's a relatively small part of our portfolio, we think this easily is resolved in time for us to have access to that cash.

Okay. Good. Thanks for that explanation. I appreciate it. That's it for me. Thank you.

Thank you. Our next question comes from the line of Jason Kantor, of RBC. Please go ahead.

Hi. Thanks a lot for taking my question. Could you -- a couple of things, one, the data that you're going to have at Lugano, what are we going to see incrementally from what we've seen before? Are we going to see higher doses or just more follow-up? What can we look forward to there?

Are you referring to SGN-40?

Unless you have something else at the Lugano meeting, and you can tell us about that as well.

Yes, we will have a bunch at the Lugano meeting, but with SGN-40 we are going to be presenting the full Phase I, which we've never actually presented on SGN-40. So we'll have complete data and durability data, and that's something we've not presented publicly, either. Tom, do you want to comment on the SGN-40 presentation at Lugano?

I think it's pretty much as Clay said, is when we did our initial presentations we had about two-thirds of the patients that were going to be enrolled in that study. This will be the full data set. And I think the piece that'll be new this time is the durability of responses. And so we're pleased with that, and we're pleased to have the opportunity to share that with you then.

Now, is this data that you had available at the time that you showed that to Genentech when they did the deal, or this has matured since then?

Well, a lot of the data has matured, because it's durability.

Okay.

So that's something that matures over time. And so we'll be presenting that.

Then, with regard to SGN-35, apparently you're seeing some really good results there, and everyone I think would like to assume that you'll see other great results with your other conjugates. Is there anything specific about the target itself in Hodgkin's disease that may make them particularly sensitive to auristatin, or is this kind of what you'd expect for a lot of your tumor types?

Thanks for the question. We do not see any specific aspects of CD30, the target of SGN-35, that uniquely prepares a cell for sensitivity to auristatin versus other cells. So we think this is more of a way that we can target a receptor on the cell surface and deliver effectively a potent cytotoxic agent that disrupts tubulin, and it's an antimitotic. And so we think that this is generalizable, and we do not think this is very specific only to CD30.

But is it at all specific to Hodgkin's disease in terms of the killing power of auristatin?

No, actually, we've done a lot of analysis on a variety of cell types, both hematologic and solid tumors. And we find that auristatin on the vast majority of cells are very sensitive to auristatin or cell killing mediated by auristatin, and we do not see that Hodgkin lymphoma stands out in any way and is more sensitive or less sensitive. It's pretty much in the middle of the pack.

Okay. Thanks a lot. I'll jump back in the queue.

Thank you.

(OPERATOR INSTRUCTIONS)

Our next question comes from the line of David Garrett, from Fortis Securities. Please go ahead.

Yes, hi, guys, and I would just echo congratulations on getting all these programs off the ground in such a timely manner. A couple of questions. The first one is for Todd. With the increase in expenses, is the split between R&D and SG&A still the same?

Yes, that stays about the same. So it's about 85% R&D, the rest G&A.

Okay, great. Thanks. And then, you guys are running an expanded Phase Ib for SGN-33 as a monotherapy, and I'm just curious. Considering that you have what you I assume hope is a registration trial ongoing as combination therapy, I'm just curious what you think you're going to get out of doing this larger monotherapy trial. Is there any chance that that trial could be used as a registration trial?

I'll start this answer and then I'll turn it over to Tom. The Phase Ib is certainly not a registration trial. What we are trying to determine is, the Phase Ia was a dose escalating trial, and we started at 1.5 mg/kg and went up to 8 mg/kg. We went into the Phase Ib because we were excited with the number of CRs that we had in Phase Ia, but since it was all at different doses and dose escalating, we didn't have any substantive amount of patients treated at what we thought was our Phase II dose of 8 mg/kg.

So we wanted to treat a substantial amount of patients, and in this case it's a total of 50 patients that are on the Phase Ib study, so that we could make a determination if it makes sense for Seattle Genetics to consider a single agent approval pathway. And until that data reads out, until we really get all those data, we're really not going to make a comment on it. We're going to let the data dictate to us whether or not we go forward in that regard.

Now, we do not want to wait. Because we thought, okay, we have this active drug. We really like the safety profile and we really like its activity. And we thought getting it in a trial in combination with an appropriate chemotherapy in a very dramatic disease, AML, which really needs additional therapies, to us it made sense to just go forward very rapidly there and not wait until we did a very -- until we did all the rest of the work on the single agent.

Now, ultimately, whether this gets approved as a combination therapy, as a monotherapy or both, I think that all of the above could be important for the drug and even if it just got approved in the future as a combination therapy, that still would offer a huge amount of upside for patients with AML. Tom, I'm sure you have some other comments, or maybe not?

Clay, that was very well said. I really don't have anything to add.

Okay. So I guess just as a follow-up, then, no matter what happens in this trial, if you were to go after a monotherapy label, you're going to have to do another study.

Absolutely.

Okay.

This is really a Phase Ib -- it was really a screening -- it's a screening study to look at responses.

But, David, I think the thing that's important about this study is if you look at both the Ia and Ib data together, I think we would be able to power a registration study very accurately based on these data should we choose to move forward with that.

Okay, great. And then just one more, if I may. What's -- I know you said you're going to update us on next steps for 35 in the second half of the year. I just was curious what's your current thinking on a registration pathway for that. I mean, is it possible to do a single arm study, or you think you're no matter what going to have to do a randomized trial?

You know, you're actually asking some very good questions. What I can tell you is that we're having a number of internal meetings now and plotting and planning, so we're working hard on this right now. We're also bringing in a lot of KOLs, or key opinion leaders, outside, that are experts in Hodgkin lymphoma, that are experts in clinical development, that are experts in regulatory. And we're evaluating whether single agent or randomized studies need to be done, or a combination thereof. So we're really looking hard at both Hodgkin lymphoma and CD35 in the T-cell lymphomas, like anaplastic large cell lymphoma. So we think that there is a lot of opportunity for us and a lot of upside in this area. And later in the year we'll be outlining specifics. Tom, is there anything you want to add to that?

I think it's fair to say that we're very pleased by the efficacy that we've seen so far and the safety profile that we've seen so far. I think we're going to be able to be pretty aggressive on how we move forward. That being said, our strategy has always been to work closely with regulatory groups, both the FDA here and the EMEA over in Europe, to ensure that we've got a lot of congruence in terms of what the best thing is for the patients in moving these products forward quickly. So I think we're going to have some really interesting things to talk about as we unroll this strategy later this year. And so stay tuned.

Right. And I think the most likely thing that we would be doing more than one site. And so I think we're excited enough about the program that we would be doing some confirmatory studies. And I think that that's something you should look forward to hearing later this year.

Great. Thanks very much.

Thank you. We have a follow-up question from the line of Jason Kantor, from RBC. Please go ahead.

Hi. Thanks for taking the follow-up. Two quick things. What changed between your last guidance and this guidance to make you decide to spend more? It sounds like you've been progressing along the path you've set forward for everyone. So what is it that exactly changed in your thinking?

I think there's a couple of things that have changed here, and maybe I can start and then Todd can also go in from a financial standpoint. I think the biggest change is our enhanced investment in SGN-35, and that's the single biggest ticket item there, and a lot of that is [to] manufacturing. We recently had an SEC filing that came out detailing a manufacturing agreement we've done with Abbott Labs that Todd mentioned in our presentation here this afternoon. And so that -- it was -- I think the numbers were -- the contract was $7.3 million, plus raw materials, which is another $1.5 million or so. And so that right there is the biggest single item.

I think that there are other items that are really important here. And that's also an additional spend that we're doing on the SGN-40 program, in collaboration with Genentech. And while that's reimbursed, that's also added expense to us, and it just shows how interested Genentech is on this program, that the expenditures continue to rise.

So I think that those are two of the larger events. There's more head count, and we're adding more head count to support really our clinical and our manufacturing initiatives, and doing our analytical work along with our clinical program. Our intention is to take some of these products to commercial launch, and we are positioning ourself to do that. We think that we have some great products, and we have the internal power to consider that, but we do need to fill some positions as we march along toward registration. So we have added head count cost, as well, built into this cost increase, this guidance increase, that we did not necessarily contemplate when we first guided, but due to our excitement with SGN-35 first and foremost that you'll hear about at ASCO, we've decided that it makes a lot of sense for us to invest more in the program. Todd, do you want to add anything to that?

No, I think that's a pretty fair characterization. I think what's changed is positive data and momentum, and that goes across SGN-35 as well as SGN-40. There are now a lot of clinical trials that we and Genentech are running. That's going through more product supply, and we want to make sure that we have an uninterrupted supply of product for all those studies, so that's included in our expenses. But I think, as I mentioned before and everyone knows, all of the development costs for that program are funded by Genentech. So it doesn't increase our burn but it certainly does show up in our expenses.

And then on 35, it's manufacturing, it's process scale-up, it's clinical development. We are excited with this program. We want to position it so that we can really drive it forward aggressively, and that involves clinical spending, head count, manufacturing, kind of everything soup to nuts, and we want to make sure we do it right.

Okay. One last question, then. You talk about refining your registration strategy and that you're going to provide details, I assume, after ASCO, for SGN-35. Is this something that you have already talked to FDA about, and you're just withholding the information until after the data to talk about, or is this -- do you still have to meet with the FDA to get the green light, and that's why the guidance is for later this year to get that kind of clarity?

Jason, it's the latter. I mean, we are -- we're formulated. We meet regularly with various regulatory agencies, whether it's the agency in the U.S. or Europe. We have international studies going on. So I don't want to (inaudible) that we're not meeting and communicating with the agency. We absolutely are. But we're not trying to hold any big material thing from you until after ASCO. We're still in progress with formulating internally everything we want to do, and we will later this year, I'm sure, request meetings with the FDA and then really lay out our pathway to the -- in an appropriate way, laying out a pathway to the public in the investment groups and the analysts.

Thanks.

Thank you. At this time, I show no further questions in the queue. I'd like to turn it back to Ms. Pinkston. Please go ahead.

Okay, thank you, operator, and thanks, everybody, for joining us this afternoon. Good evening.

Ladies and gentlemen, this concludes the first quarter 2008 financial results conference call. If you'd like to listen to a replay of today's conference, please dial 1-800-408-2236, and followed by 11112001#.

(Inaudible) would like to thank you for your participation. You may now disconnect.