Seattle Genetics, Inc. (NASDAQ:SGEN) Q4 2018 Earnings Conference Call Transcript

Feb 07, 2019 • 04:30 pm ET


Seattle Genetics, Inc. (NASDAQ:SGEN) Q4 2018 Earnings Conference Call Transcript


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Good day and welcome to the Seattle Genetics Fourth Quarter and Year 2018 Financial Results. Today's conference is being recorded. At this time, I would like to turn the conference over to Ms. Peggy Pinkston, Vice President, Investor Relations. Please go ahead ma'am.

Peggy Pinkston

Thank you, operator, and good afternoon everyone. I'd like to welcome all of you to Seattle Genetics' fourth quarter and year 2018 conference call. With me today are Clay Siegall, President and Chief Executive Officer; Todd Simpson, Chief Financial Officer; Roger Dansey, Chief Medical Officer; and Darren Cline, Executive Vice President, Commercial.

Accompanying today's conference call are supporting slides which are available on our website in the Investors section the Events and Presentations page. Following our prepared remarks today, we'll open the line for questions. Today's conference call will include forward-looking statements regarding future events or the future financial and operating performance of the company such as those, among others, relating to the company's 2019 financial outlook, including anticipated 2019 ADCETRIS sales and future revenues, costs and expenses; the company's potential and anticipated timing to achieve future clinical and regulatory milestones and published data for ADCETRIS, enfortumab vedotin, tucatinib and tisotumab vedotin. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Among the factors that may cause such a difference include the difficulty in forecasting sales, revenues and expenses and the uncertainty associated with the pharmaceutical development and regulatory approval process.

More information about the risks and uncertainties faced by Seattle Genetics is contained under the caption Risk Factors included in the company's periodic reports filed with the Securities and Exchange Commission, including the company's quarterly report on Form 10-Q for the quarter ended September 30th 2018 and future periodic reports filed by the company, including the company's annual report on Form 10-K for the year ended December 31st 2018.

Now, I'll turn the call over to Clay.

Clay B. Siegall

Thanks, Peg and good afternoon, everyone. 2018 was a remarkable year highlighted by significant ADCETRIS achievements and substantial progress with our late-stage clinical portfolio bringing us closer to becoming a multi-product oncology company. In 2018, ADCETRIS was launched in two frontline indications and is becoming the foundational therapy in CD30-expressing lymphomas. We expect to continue our momentum in 2019, including maintaining focus on ADCETRIS commercial growth. Beyond ADCETRIS are three late-stage programs in solid tumors that are approaching near-term milestones.

Importantly in 2019, we'll report data from pivotal trials with enfortumab vedotin and tucatinib. In March, ADCETRIS in combination with chemotherapy was approved for Stage III and IV Hodgkin lymphoma based on the ECHELON-1 trial and in mid-November ADCETRIS in combination with chemotherapy was granted breakthrough therapy designation and then approved in frontline CD30-expressing peripheral T-cell lymphoma based on a positive results from the ECHELON-2 trial.

The PTCL approval came 11 days after submission under the FDAs real-time oncology review (technical difficulty) progress. This is a testament to the strength of data, close collaboration with FDA and our commitment to bringing ADCETRIS to