Seattle Genetics CEO Discusses Q3 2010 Results - Earnings Call Transcript

Seattle Genetics, Inc. (

SGEN

)

Q3 2010 Earnings Call

November 1, 2010 5:00 PM EST

Executives

Peggy Pinkston – Director, Corporate Communications

Clay Siegall – President and CEO

Todd Simpson – CFO

Bruce Seeley – EVP, Commercial

Tom Reynolds – Chief Medical Officer

Eric Dobmeier – Chief Business Officer

Analysts

Adnan Bhat – RBC Capital Markets

Mark Monane – Needham & Company

Marko Kozul – ThinkEquity

Matt Lowe – JPMorgan

John Eckard – Leerink Swann

John Sonnier – William Blair

George Farmer – Canaccord Genuity

Brett Holley – Oppenheimer & Co.

Keay Nakae – Chardan Capital

David Miller – Biotech Stock Research

Chris Schaefer – UBS

Ling Wang – Brean Murray

Presentation

Operator

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Good afternoon, ladies and gentlemen, and thank you for standing by. Welcome to the Seattle Genetics third quarter 2010 financial results conference call. During today’s presentation, all participants will be in a listen-only mode. Following the presentation, the conference will be opened for questions. (Operator Instructions).

As a reminder, today’s conference is being recorded, Monday, the 1

st

of November, 2010.

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

Peggy Pinkston

Thank you, operator. I’d like to welcome all of you to the Seattle Genetics third quarter 2010 conference call. With me today are Clay Siegall, President and Chief Executive Officer; Todd Simpson, Chief Financial Officer; Eric Dobmeier, Chief Business Officer; Tom Reynolds, Chief Medical Officer; and Bruce Seeley, Executive Vice President, Commercial.

This afternoon, Clay will provide an update on our programs, including recent highlights and upcoming activities, and Todd will discuss our third quarter and year-to-date 2010 financial results. After that, we’ll open the call for your questions.

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 filed 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. It’s been a fantastic past couple of months for brentuximab vedotin and Seattle Genetics. The remarkable top line data we reported from both our pivotal Hodgkin lymphoma and our Phase II anaplastic large cell lymphoma trials are an important step towards our goal of bringing this promising product candidate to patients in need.

We believe the data strongly position us for a planned PLA submission in the first half of 2011. And we are executing on the initiatives necessary for a potential product launch in the second half of 2011.

We have also demonstrated substantial progress with our other programs, including encouraging early data from our ongoing SGN-75 Phase I trial and initiation of a second Phase I trial with ASG-5ME. In addition, our proprietary ADC technology is driving an increasing number of programs in clinical trials by our collaborators and we received more than $40 million under our ADC deals this year alone. We have strong positive momentum and are poised to achieve substantial milestones before the end of 2010 and throughout 2011.

This afternoon, I’ll summarize our recent progress and upcoming activities, starting with brentuximab vedotin, also known as SGN-35 or B-vedotin. This is an ADC targeting CD30, the defining marker for Hodgkin lymphoma and target also highly expressed on a number of T-cell lymphomas, including anaplastic large cell lymphoma or ALCL.

In September, we reported top line data from our pivotal trial in relapsed and refractory Hodgkin lymphoma that is being conducted under a special protocol assessment. In this trial, 75% of the 102 patients enrolled achieved an objective response based on independent central review. The median duration of response was greater than six months.

And in October, we reported top line data from another clinical trial with B-vedotin, a Phase II trial in patients with relapsed or refractory ALCL. In the Phase II study, 86% or 50 of the 58 patients enrolled achieved and objective response based on independent central review. The median duration of response has not yet been reached at a median follow up on study of approximately six months.

The safety profile of B-vedotin in both of these trials was generally consistent with prior clinical trial experience.

These data confirm our high expectations for this program. Few single agents have demonstrated this level of response in a relapsed refractory cancer setting. We are particularly encouraged by these results, given that we tried a difficult patient population.

All patients in both trials had previously failed multiple lines of therapy and most had primary refractory disease, defined as patients who would either failed to respond to or who relapsed within three months of receiving frontline treatments. And in the Hodgkin trial, all patients had relapsed followed an autologous stem cell transplant.

We believe these data underscore the importance of targeting CD30 in the treatment of Hodgkin lymphoma and ALCL and providing provide validation for our proprietary ADC technology.

We’re looking forward to reporting more complete data sets from these trials in two oral sessions during the ASH Annual Meeting in December. The Hodgkin lymphoma data will be presented on Monday morning, December 6

th

at 7:00 AM. And the ALCL data will be presented on Tuesday morning, December 7

th

at 7:30 AM. The presentations will include further details on durability of response and the safety profile, as well as secondary endpoints including complete response rate and progression-free survival.

Based on the strength of the data from these two trials, we are optimistic about our regulatory path forward with B-vedotin. We plan to meet with the FDA later this year to discuss the BLA submission plan for the first half of 2011, including our goal getting approval for relapsed, refractory Hodgkin lymphoma and ALCL.

In addition, Millennium, our collaborator on the commercialization of brentuximab vedotin outside of the US and Canada intends to discuss these data with European regulators towards its goal of submitting a marketing authorization application to the European Medicines Agency in 2011.

After recent international symposium on Hodgkin lymphoma meeting in Germany, we presented clinical and preclinical data on B-vedotin in multiple poster presentations. We were gratified by the enthusiasm against Hodgkin lymphoma physicians for the potential of B-vedotin to address the unmet needs of patients, including exploration of its use in earlier lines of therapy through clinical trials.

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