Seattle Genetics, Inc. Q3 2008 Earnings Call Transcript

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 |  About: Seattle Genetics, Inc. (SGEN)
by: SA Transcripts

Seattle Genetics, Inc. (NASDAQ:SGEN)

Q3 2008 Earnings Call Transcript

October 23, 2008, 5:00 pm ET

Executives

Peggy Pinkston – Director of Corporate Communications

Clay Siegall – President and CEO

Todd Simpson – CFO

Tom Reynolds – Chief Medical Officer

Eric Dobmeier – Chief Business Officer

Analysts

Mark Monane – Needham & Company

Jason Kantor – RBC Capital Markets

Bret Holley – Oppenheimer & Company

David Miller – Biotech Stock Research

Katherine Kim – Banc of America Securities

Operator

Ladies and gentlemen, thank you for standing by. Welcome to the Seattle Genetics third quarter 2008 financial results conference call. During today’s presentation, all parties will be in a listen-only mode. Following the presentation, the conference will be opened for questions. (Operator instructions) This conference is being recorded today, Thursday, October 23, 2008.

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

Peggy Pinkston

Great, thank you very much operator. I'd like to welcome you all to Seattle Genetics third 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.

Clay Siegall

Thanks, Peg, and thank you all for joining us this afternoon. I’m pleased to say that Seattle Genetics is well positioned and continues to make excellent progress. Our product portfolio is diverse with four programs in 12 clinical trials, compelling clinical data from our three lead product candidates and multiple promising preclinical agents. We have eight collaborations that provide financial and strategic benefits. And our balance sheet is strong. We ended the third quarter with more than $187 million in cash and investments, and we have no debt.

Today I’ll provide a brief update on our programs and collaborations. Then I’ll turn the call over to Todd to discuss our financial results, after which we’ll open the call for your questions.

I’ll start with SGN-40, which we’ll refer to from now on as dacetuzumab, the USAN name we recently secured. In collaboration with Genentech, dacetuzumab is currently in six clinical trials for non-Hodgkin lymphoma and multiple myeloma. Accrual to the Phase II single-agent trial in diffuse large B-cell lymphoma is complete, and we plan to report data during the annual meeting of American Society of Hematology or ASH, being held in San Francisco in early December. In addition, two preclinical presentations on dacetuzumab are planned for ASH, one of which will describe its activity when combined with Rituxan and the other regarding a diagnostic gene signature.

Based on preclinical research conducted by Genentech and presented at the AACR Molecular Diagnostics Conference in September, a gene signature they identified may be predictive of anti-tumor activity in patients with non-Hodgkin lymphoma. We are correlating this novel tool with clinical findings from our studies of dacetuzumab for lymphoma.

The biggest of our ongoing dacetuzumab clinical trials is a Phase IIb randomized placebo-controlled study of Rituxan-ICE plus or minus dacetuzumab in 220 second line diffuse large B-cell lymphoma patients. Data from this trial, which is assessing the therapeutic benefit of adding dacetuzumab to standard second line therapy, are expected in 2010. We are also executing on four combination Phase Ib clinical trials of dacetuzumab that will generate data starting in 2009.

Our dacetuzumab program continues to progress well and provides us with multiple opportunities for success. Through our collaboration with Genentech, we have broadened the scope of this program towards our goal of reaching patients in need of new and better therapies to treat their disease.

The second program I’d like to talk about is lintuzumab or SGN-33, which is moving forward at a strong pace. We have three clinical trials underway for acute myeloid leukemia and myelodysplastic syndrome. Data are expected from the Phase Ib trial in AML and MDS patients during 2009, and our Phase I trial of lintuzumab plus Revlimid in patients with MDS is ongoing.

The largest of our lintuzumab study is the Phase IIb trial in older patients with AML. This is a randomized trial comparing overall survival in patients receiving low-dose cytarabine plus or minus lintuzumab. If we can demonstrate that the addition of lintuzumab leads to a meaningful survival advantage for these older patients who have limited alternative therapies, we believe there may be a rapid path to approval. Accrual is robust and the trial is on track to yield data likely in the first half of 2010.

Our third clinical program is SGN-35 or antibody-drug conjugate or ADC targeted to CD30. We are developing this product candidate for Hodgkin lymphoma and CD30 positive T-cell lymphoma, including systemic anaplastic large-cell lymphoma or ALCL. We reported positive interim Phase I data at ASCO in June that support an aggressive development pathway for this program. In particular, at doses at or above 1.2 milligram per kilogram administered every three weeks, 45% of patients had objective responses, including 23% with complete responses. Moreover, 81% of patients across all dose levels had reductions in tumor volumes. Accrual to this trial is complete, and we plan to present additional data including updated response rate and durability at ASH in December.

Another Phase I trial is also ongoing to assess weekly administration of SGN-35. This study is designed to enhance our understanding of the therapeutic application of our ADC technology and to further explore the efficacy and safety profile of SGN-35. Accrual to the trial is going very well with new patient cohort often being filled on the same day they are opened.

As with our first Phase I trial, this indicates to us a high level of patient and physician interest in SGN-35. SGN-35 has the potential to address a significant unmet medical need for patients with relapsed or refractory Hodgkin lymphoma and CD30-positive T-cell lymphomas. We are collaborating with the FDA to finalize our pivotal trial design. Specifically, we have submitted two special protocol assessments, or SPAs, for parallel pivotal clinical trials in patients with relapsed or refractory Hodgkin lymphoma and systemic ALCL.

We’ve planned to lay out a more detailed view of registration strategy within the next few months as we complete our discussions with the agency and anticipate initiating pivotal trials in the first half of 2009. We are also working with the regulatory agencies in Europe to develop our registration pathway in the EU. The rationale for our rapid registration strategy is our impressive Phase I data, including response rate, durability, and tolerability profile, as well as the fact that there is no standard of care and limited therapeutic alternatives in the relapsed and refractory lymphoma setting.

Although frontline therapies for Hodgkin and T-cell lymphomas often achieve long-term remissions, a significant number of patients require additional treatment, including stem cell transplant and chemotherapy regimens. Based on our market research, we believe there is a substantial commercial opportunity for SGN-35. We project worldwide sales potential for SGN-35 in relapsed or refractory Hodgkin lymphoma and ALCL of $300 million to $400 million annually. Beyond that, we believe there is substantial upside including the use of SGN-35 in frontline lymphoma and relapse prevention settings in combination with or as alternative to chemotherapy.

Preclinical data are being presented this week at the EORTC-NCI-AACR meeting taking place in Geneva, Switzerland, demonstrating enhanced activity of SGN-35 when combined with chemotherapy, including the standard frontline regimen ABVD and with Gemzar. SGN-35 may also have application in the treatment of autoimmune indications in graft-versus-host disease through its potential to deplete activated but not resting T-cells. Development activities in these additional areas of unmet patient need are underway. SGN-35 is a high priority exciting program for all of us at Seattle Genetics, and we expect to update you on specifics as they relate to our US registration strategy within the next few months.

During the third quarter, we also initiated a Phase I trial of SGN-70, a humanized antibody targeting that we are developing as a novel therapy for autoimmune diseases. Because of its ability to specifically target activated T and B-cell, but not resting lymphocytes. SGN-70 may reduce the damaging effects of autoimmune disease without globally suppressing the immune system. In the ongoing clinical trial, we are assessing the safety and pharmacokinetics of SGN-70 in healthy volunteers to provide the data necessary to define future clinical trials in patients with autoimmune disease.

We are also advancing multiple preclinical ADCs, including two propriety programs for cancer, SGN-75 and SGN-19A. We are completing preclinical studies in SGN-75 to support a planned IND filing in 2009. This program has therapeutic potential in both hematologic malignancies and solid tumors. Preclinical data from our SGN-19A program and ADC-targeting CD19 will be presented tomorrow at the EORTC-NCI-AACR meeting. The data demonstrate that SGN-19A reduces anti-tumor activity in multiple types of hematologic malignancies, including complete regression in models of non-Hodgkin lymphoma and acute lymphocytic leukemia.

In addition to our internal ADC programs, we are co-developing AGS-5 ADC with Agensys, a subsidiary of Astellas, for solid tumors. We also have collaborations with six companies that have licensed our ADC technology to power their own antibodies. Three of these collaborators, CuraGen, Progenics, and Genentech, are conducting clinical trials with ADCs utilizing our technology.

We’ve recently achieved a milestone triggered by Progenics, initiation of a Phase I trial of their PSMA ADC for prostate cancer. CuraGen is in Phase II trials with CRO-11 ADC for melanoma and breast cancer. And Genentech is conducting a Phase I trial of an ADC in cancer. We also recently achieved a preclinical milestone under our collaboration with Genentech, reflecting progress with another ADC. This is the sixth milestone achieved under our ADC collaboration with Genentech. So far in 2008, our ADC collaborations have generated more than $9 million for Seattle Genetics.

In addition to these highlights, our ADC collaborations with Bayer, MedImmune, and Daiichi Sankyo are also making strong progress. We expect additional ADCs utilizing our technology to advance into the clinical in 2009 and beyond.

Our key goals over the remainder of 2008 and into 2009 include the following. For dacetuzumab, reporting data from our Phase II single-agent in DLBCL as well as preclinical findings at ASH, advancing our five other ongoing clinical trials and reporting additional data in 2009. For lintuzumab, completing our Phase Ib single-agent trial and moving our global Phase IIb trial in older AML patients toward completion in the first half of 2010. For SGN-35, presenting additional data at ASH, finalizing our development in the regulatory strategy in the next several months and initiating pivotal trials in the first half of 2009. For SGN-70, completing the Phase I trial in healthy volunteers and positioning the program for further investigations with patients with autoimmune disease. And for SGN-75, filing an IND for a Phase I trial in CD70 positive malignancies.

Seattle Genetics is executing well its position for success. We have a deep product pipeline, clinical validated ADC technology, the financial resources to invest and advancing our programs and substantial momentum for the remainder of 2008 and heading into 2009. I look forward to sharing our future progress.

I’d now like to turn the call over to Todd to discuss the financial results.

Todd Simpson

All right. Thanks, Clay. And thanks everyone for joining in on the call this afternoon. Our third quarter 2008 financial results were in line with our expectations and continued to reflect year-over-year increases in both our revenues and expenses resulting from the expanded activities in our pipeline that Clay just described.

For the third quarter of 2008, revenues increased 74% over 2007 to $8.1 million. And revenues increased 73% for the year-to-date 2008 to $25.2 million. These revenues primarily reflect amounts earned under our dacetuzumab collaboration with Genentech, which increased both in the quarter and year-over-year in 2008. Our ADC collaborations also contributed to revenues.

Year-to-date revenues in 2008 reflect multiple clinical and preclinical milestones and other payments received under our collaborations with Genentech, Bayer, and CuraGen, as each of these collaborators advance products utilizing our technology. ADC revenues in 2008 also reflect the earned portion of the $4 million upfront payment received in July from Daiichi Sankyo, which is being amortized into revenue over the research time of the agreement.

Operating expenses in the third quarter of 2008 increased to $31.4 million and $85.1 million for the year-to-date. This compares to $21 million for the quarter and $53.7 million for the year-to-date in 2007. The planned increases in 2008 expenses continue to reflect higher R&D expenses, which were $73.4 million for the year-to-date in 2008 compared to $44.7 million for the year-to-date in 2007.

The principal drivers of these increases are as follows. First, increased clinical development expenses reflecting our 12 open clinical trials primarily for dacetuzumab, lintuzumab, and SGN-35. Second, higher manufacturing cost for dacetuzumab, lintuzumab, and SGN-35 to enable continued supply of drug for our trials. And lastly, increased employee cost, primarily driven by growth in our clinical and development groups.

I will also note that total operating expenses include non-cash share based compensation expense of $7.4 million for the year-to-date in 2008 compared to $5.4 million for the same period in 2007. And as a reminder, dacetuzumab collaboration cost including al of the manufacturing and clinical costs that I described are included in our operating expenses that are fully reimbursed by Genentech under the collaboration.

We ended the third quarter of 2008 with approximately $187 million in cash and investments. Given the current global financial requirement, we continue to monitor our investment portfolio carefully. Our portfolio is made up of investment grade securities with maturities aligned with our operating requirements, giving us good liquidity to meet our needs. Over $100 million is currently held in US Treasury money market accounts or investment grade paper maturing within the next year.

Previously we’ve guided that our year-end cash balance would be more than $140 million. However, so far in 2008 we have generated higher than expected cash from ADC collaboration payments and proceeds from stock option exercises. And as a result, we now expect in 2008 with closer to $150 million in cash and investments, and to be at or below the low end of our guidance of $75 million to $85 million of cash used to fund our operating activities.

So with that, I will turn the call back over to Clay.

Clay Siegall

Thanks, Todd. Operator, at this point, we’d like to open the call for questions.

Question-and-Answer Session

Operator

Thank you. (Operator instructions) Our first question comes from the line of Mark Monane with Needham & Company. Please go ahead.

Mark Monane – Needham & Company

Good afternoon. Greetings from New York City. And thanks for reviewing the very busy third quarter. A couple of questions. I’m going to start with some very concrete questions to begin. Let’s start with 35. Is the experience – can you describe the experience so far, Clay, in terms of thinking about patients who have already been treated with frontline therapy? In the refractory setting, do these patients respond equally well depending on what therapy they get in the frontline? And then second question is, do you see any inherent effects of the anti-CD30 in these patients? Or do you believe the clinical effect is due to the payload and the ADC technology?

Clay Siegall

Thank you for the questions, Mark. First of all, I’ll address the second question and then I’ll turn it over to Tom to address the first question. The second question, I think that we had already done a pretty detailed clinical analysis through testing. SGN-30, the naked antibody, that’s present – that’s part of the major component of SGN-35, which is the antibody carrying the orastatin [ph] payload. And SGN-30 on its own with that agent, we saw no objective responses in Phase II Hodgkin lymphoma, and we saw a modest level of response in ALCL. I think it was about 17% or so response with ALCL. And so we know those data. Now we have the data that we’ve reported at ASCO. And we’ll be updating at ASH with the newest data with duration, response rate, etc. But what we’ve reported at ASCO was 45% response rate, clearly way above where the naked antibody comes from. In our opinion based on our preclinical data and our clinical data, it clearly comes from binding to the target, but the major source of the efficacy is the delivery of the payload. So we believe that really is the key here, that delivery of the payload utilizing our ADC technology. Now I’ll turn it over to Tom to talk about the patients.

Tom Reynolds

Right. So, Mark, I think you kind of have a two-parter for me. One is what's the kind of mix in terms of what patients get frontline and then how do they respond, and is there any difference. The majority of our patients are treated with ABVD upfront that’s currently the standard of care in the US, which is where the trial is being run. So nearly all of our patients have had that with the exception of the few ALCL patients that we’ve had on the initial Phase I, which typically get a CHOP-type regimen. So almost everybody has either had ABVD or CHOP, and there doesn’t appear to be any difference depending on that. What happens next then is for patients that relapse is as a large fraction of those go on to autologous stem cell transplant. And we've done an analysis to look at patients that have received 35 prior to transplant or post-transplant. The majority of the patients have already received autologous transplant. And there just not appear to be a difference in terms of their ability to respond to 35 as to whether they have had – what they have had second line, either pre- or post-transplant, or how many prior therapies they have had of any sort.

Mark Monane – Needham & Company

That was helpful. If we can move to 33 – sorry, it’s no longer 33. It’s lintuzumab. Can you talk about what you plan to learn from the Ib single-agent trial, given the fact you are already in the pivotal trials? And if you learn anything really important, is it too late to modify the protocol?

Clay Siegall

Sure. Briefly we have reported and I just look back at what – was that ASH 2007, I believe? We reported single-agent activity with this antibody in a small population of patients. And so we are most interested, and even at that point, we were more interested in progressing to our international Phase IIb study, lintuzumab plus and with ARA-C versus ARA-C. And that study is our key most important study. Well, what we wanted to do while we were progressing and organizing and opening the ARA-C study, which is a combination with lintuzumab study, which is going very well, and accrual is robust in that study. But while we were opening that, we were – we decided to expand the number of patients we were treating in the Phase Ia study, calling it a Phase Ib, and just to get more signal from the patients on efficacy, on safety and pharmacokinetics. And we were really studying this drug in a somewhat larger patient population. We were going to add another 50 patients to the initial study we did. But make no bones about it, our lead, our most exciting SGN-33 or lintuzumab program is our very large -- for Seattle Genetics’ size, it was the largest study that we’ve ever undertaken in 220 patients, looking for I believe it’s 486 events. And Tom, you can talk about that a little bit more.

Tom Reynolds

Sure. So just a little bit more color on the Ib, it’s enrolling both AML and MDS patients. And we’ll have much better idea of how well tolerated that is in a larger population as well as responses and longevity in both MDS and AML. So we think that’s important in terms of planning what we do in addition to the Phase IIb. Phase IIb is going well. It’s a survival study. We’ve already told you in prior calls that, should we hit a meaningful difference in survival endpoints, then we think that that could be sufficient to take to registration. So we’re actively moving forward. This study has picked up a lot of speed and it is cranking through and we're very optimistic about how this is going at this point.

Mark Monane – Needham & Company

And then on the partnering aspects, we know that dacetuzumab is already partnered. Is there Genentech interest in lintuzumab or have other companies approached you? And what kind of qualities in a partner are you looking for for the other clinical programs that are underway?

Clay Siegall

That would be an appropriate question for Eric Dobmeier as he is running traction on all our business strategy and relationships. Eric?

Eric Dobmeier

Hey, Mark. Yes. So I guess on the specific part of your question about Genentech, I think we’ve said on previous calls that our main focus for our other programs, in particular lintuzumab and SGN-35 is to pursue ex-US partnering deals. And that’s not a deal structure that Genentech in its current form can do. So they wouldn’t be our first choice for partnering those programs. But we do have quite a number of other companies that we’re talking to. And the goal here would be for us to be able to build our own commercial infrastructure in the HEMOC [ph] space in the United States, but to have a partner who can help us with regulatory and clinical and commercialization activities outside the US. So in terms of what kind of partner we’d be looking for, it’s all the standard stuff. Somebody who has got late-stage experience, an oncology franchise, particularly in HEMOC, a company that can really supplement our resources and expertise outside the US. In a broader sense, when you look at our pipeline, we have seven programs. Dacetuzumab, as you said, is partnered with Genentech. And then we have a preclinical program, AGS-5 ADC that’s partnering with Agensys or Astellas. The five programs – the other five programs in our pipeline, which are lintuzumab, SGN-35, SGN-70 and 75, and SGN-19A, are all moving forward well. And we have the resource to keep progressing them, but we do have a lot in our play. So there are other potential deal structures we’re considering where for some of the earlier assets we could potentially do a deal that brings in some additional capital and supplements what we can do. So there is a lot going on in the partnering front. It’s definitely something we look forward to sharing with you in the future.

Mark Monane – Needham & Company

Thanks, Eric. I’ll step back in the queue so my colleagues can proceed. We appreciate the added information.

Operator

Our next question comes from the line of Jason Kantor with RBC Capital Markets. Please go ahead.

Jason Kantor – RBC Capital Markets

Thank you for taking the questions. I have several. So, on your regulatory strategy for SGN-35, you said one of – have two different SPAs. First, why do you feel the need for an SPA in the case of what is the aspect for the trial that you are trying to nail down with the SPA? And then with regard to having two SPAs, is it a separate one for Hodgkin’s disease and ALCL, or is it separate one for later stage versus earlier stage diseases?

Clay Siegall

Jason, thanks for the question. They are two separate SPAs. One for Hodgkin lymphoma and one for ALCL. That’s the way they are breaking down, separate indications. But your specific questions, I’ll turn over to Tom.

Tom Reynolds

Right. So, Jason, as I’m sure you’re well aware of, for a special protocol assessment, our goal really is to have the FDA buy into the entire protocol structure, including endpoints, patient population on how we’re going to do certain assessments, and all the pieces so that when we come to them at the end of the day, our expectations and their expectations are aligned, and that this becomes an easy process for them to evaluate this in the setting of unmet need for both of these diseases. So it’s really to seek a closure with them on all of these parts of the protocol.

Jason Kantor – RBC Capital Markets

Okay. And then with regard to the conjugate deals, you are starting to book lot more revenue as these companies hit these milestones, and clearly partners are willing to pay more for these deals with all the clinical validation. Is this going to become an increasing part of your partnering efforts to do more of these deals at higher valuations?

Eric Dobmeier

Hey, Jason, it’s Eric. It’s certainly been – I think it’s been a pretty consistent aspect of our business over the years. We did one deal this year with Daiichi Sankyo, which as you mentioned had some higher financial terms in it than previously. We did one deal in ’07 with Agensys that gave us a product right actually through co-dev and options to ADC programs. So I think you will see us continue to do deals. It’s not our main focus, but a deal or two a year is a reasonable expectation. And you are right. As ADCs become more validated, we’re going to see a lot more interest from larger pharmaceutical and biotech companies in getting into the space and being involved with ADCs.

Jason Kantor – RBC Capital Markets

And then you mentioned Agensys. Can you give us an update as to where those programs stand? Is that something you are co-developing?

Eric Dobmeier

Yes, on AGS-5 ADCs in preclinical development, we haven’t laid out a specific timeline for when it would move into the clinic. It's a solid tumor antigen. The collaboration is going well. And I don’t think we have anything too specific to say about it at this point.

Clay Siegall

Yes. The collaboration is going well. And I think that in the future we’ll talk about that.

Jason Kantor – RBC Capital Markets

Thanks.

Operator

Thank you. Our next question comes from the line of Bret Holley with Oppenheimer & Company. Please go ahead.

Bret Holley – Oppenheimer & Company

Yes, hi. Thanks for taking the question. I was just wondering what the appropriate historical data for us to use for putting the SGN-35 data in context when we – especially the duration of response data, once we get that data at ASH. I mean, is there a good historical data that we can be comparing to other than transplant?

Tom Reynolds

Yes. This is Tom, Bret. So there is a couple issues. One is that there were no approved agents for relapsed or refractory Hodgkin lymphoma. So there is no label you can go to kind of see what people have done in controlled studies. For patients in that setting right now, there are a number of agents that can be used. There is vinca alkaloids, there is gemcitabine, which is used off-label, and there are high-dose combo chemo regimens that are also being explored right now, as well as experimental therapies. So those are the options. What people have been able to see is that there is a minority of patients, especially following stem cell transplant, they can tolerate high-dose chemo. Most of the other regimens, either the vinca alkaloids or gem have only – we’ve only seen published data on essentially single-center or small studies. Most of them are less than 30 patients, most of them were single-arm, and most of them have response rates not defined by current criteria that we use to stringently evaluate response that are in that maybe 20%, 30%, 40% range. So we feel we’re kind of at the upper end of that range. Durabilities are all over the map. In brief, most of them are in the two to four-month range. There is at least one study that might suggest the median duration might be around six months. But those are typically now done in a mix of pre and post-transplant patients. So it’s hard to get comparative data. Our belief after looking at all the data is that we are clearly better than what is out there. And our investigators really are putting patients now on SGN-35 rather than things like Gemzar when they come back failing transplant.

Bret Holley – Oppenheimer & Company

And what – the data at ASH, what is the longest patient follow-up we’re going to have from that data – in that data, sorry?

Tom Reynolds

Yes. So we’ve – the protocol is written so that the patients can receive drug for up to a year. And we have patients that haven’t been received drug for that period of time. The only way they can receive drug for that length of time is that they are experiencing clinical benefit.

Bret Holley – Oppenheimer & Company

Okay. That’s very helpful. And then my other question was on frontline Hodgkin’s and what your plans – your clinical plans were there. I think you referred to some preclinical data that’s highly suggested. I’m just wondering how you move forward in the clinic in earlier line Hodgkin’s, SGN-35?

Clay Siegall

We have been very pleased that there has been a lot of interest from key opinion leaders and investigators all over the world about how to move this drug faster up in the front line. We have a number of things that we’re evaluating right now with thought leaders and others in the field. And as we rolled our strategy later this year for our first approvals, we hope to be able to start telegraphing some color about how to do that. We think there is a pathway forward to move this earlier. We’d like to see SGN-35 evaluated as a way to show great responses in younger patients’ front line without causing the late toxicities that we see with the current regimen, secondary malignancies, cardiac disease, and other co-morbidities as a result of either radiation and/or high-dose chemos. So we think there is a nice path forward and we are pursuing that and hope to give you a lot more color about that in the coming months.

Bret Holley – Oppenheimer & Company

Okay. Thanks very much.

Operator

(Operator instructions) And our next question comes from the line of David Miller with Biotech Stock Research. Please go ahead.

David Miller – Biotech Stock Research

Hi, great. Thanks for taking my question. Most of them have been answered, but I was just trying to get a sense as if you had a guess as to what year the SGN-35 pivotal trial data or the BLA filing would be, so we get sense about how long these trials might take.

Clay Siegall

Sure. As far as the pivotal studies, we look to start, as we said on the call, as early as we can in ’09. And those studies take sometime to run and follow up with the data. But I think that based on that, I can see a clear vision toward filing for approval in 2011 and trying to get approval for 2012. And we’re trying to market it in 2012.

David Miller – Biotech Stock Research

Okay, great. That’s all I got. Thank you.

Operator

Thank you. (Operator instructions) And we have a follow-up question from the line of Jason Kantor with RBC Capital Markets. Please go ahead.

Jason Kantor – RBC Capital Markets

Thank you. Eric, you talked about looking for active responders for some of your clinical or perhaps preclinical programs. Can you give me a sense of how many of your programs you are actively looking to partner currently, and can you help set any kind of expectation for when we might see the first such deal?

Eric Dobmeier

Well, our main focus, our highest priority would be looking for ex-US partners for lintuzumab and SGN-35. So those deals are probably the furthest along, those deal discussions. We’re obviously not going to partner all of our programs in one massive deal, and we want to maintain a lot of upside for us as an independent company. I could see partnering one or two programs. And it’s a reasonable timeframe. Sometime next year we would expect to be able to update you on this. And when we look at our partnering strategy, it has to be considered in connection with financing as well. We are in a strong financial position now to move our programs forward, but we want to make sure we stay that way. So we look at this from a cost benefit [ph] perspective. When we look at what strategically that keeps us moving forward through a combination of right kind of either partnering deals, technology (inaudible). We look at it holistically. And the best way to get a good deal is also to be strong and have alternatives.

Jason Kantor – RBC Capital Markets

Thanks.

Operator

Thank you. Our next question is a follow-up question from the line of Mark Monane with Needham & Company. Please go ahead.

Mark Monane – Needham & Company

Thank you. Can you comment on the opportunity of introducing an antibody in multiple myeloma, specifically the trial with – I believe the trial with Revlimid that you have underway as well as the trial with Velcade in multiple myeloma partnered with – in combination with dacetuzumab. How were those phases progressing?

Clay Siegall

We have trials with dacetuzumab or SGN-40 in myeloma. And those are – we have two trials. One is in combination with Revlimid and one is in combination with Velcade. And those are the trials, and I think that’s probably what you are referring to. And those trials accruing and going along very well. And we look to putting out data on those trials in 2009. And we’re excited with the myeloma opportunity, and we think that myeloma is the type of disease that ultimately will be treated with the combination of an antibody and an effective cytotoxic agent. And so we see there is a big upside there for antibody therapies.

Mark Monane – Needham & Company

Thank you.

Operator

Thank you. Our next question comes from the line of Katherine Kim from Banc of America Securities. Please go ahead.

Katherine Kim – Banc of America Securities

Hi. My question has to do with your interactions with the FDA. What we’ve been seeing is there has been a lot of pushback in terms of timing, on PDUFA dates and just meetings with the FDA. So can you just talk about – as it relates to your interactions with regarding the SP process for SGN-35? And if your timelines include kind of a slight pushback just from a regulatory perspective? Thank you.

Clay Siegall

Sure. I have to say so far we’ve had an excellent relationship with the FDA. And we called a collaboration actually because they have been very helpful and worked with us closely on a lot of our programs, including SGN-35. Specifically for SGN-35, having filed two SPAs with them, there is a defined clock on that of 45 days for their response to come. And clearly, as you’ve indicated, the FDA is somewhat understaffed, and there are sometimes where they're not able to meet their strict deadlines because they are understaffed and trying to fill staff right now, as they have publicly stated many times. But we are definitely optimistic that the FDA will give us our feedback as close to the schedule as possible and move from there. So we’re – so far, we’re pretty excited with the way they have been interactive with us I have to say.

Katherine Kim – Banc of America Securities

Okay, thank you.

Operator

Thank you. And at this time, I’m showing no further questions in the queue. I’d like to turn the call back over to Ms. Pinkston.

Peggy Pinkston

Thank you, operator. And thanks to everybody for joining us this afternoon. Have a good evening.

Operator

Ladies and gentlemen, this concludes Seattle Genetics third quarter 2008 financial results conference call. If you would like to listen to a replay of today’s conference, please dial 303-590-3000 or 800-405-2236 with an access code of 11120729. Thank you for your participation. You may now disconnect.

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