Analyst Conference Summary

Biotechnology

conference date: October 25, 2018 @ 1:30 PM Pacific Time
for quarter ending: September 30, 2018 (third quarter, Q3)

Forward-looking statements

Overview:

Basic data (GAAP):

Revenue was $ million, up % sequentially from $170.2 million, and up % from $ million in the year-earlier quarter.

Net income was $ million, up sequentially from $76.3 million, and up from negative $ million year-earlier.

EPS (earnings per share, diluted) were $, down sequentially from $0.47 and down from negative $ year-earlier.

Guidance:

Conference Highlights:

Clay Siegall, CEO said ""

Adcetris (brentuximab vedotin) sales for CD30-positive malignancies (Hodgkin Lymphoma and relapsed systemic ALCL) in the quarter were $ million, up % sequentially from $122.4 million, and up % from $ million year-earlier.

Collaboration and license revenue was $ million, down sequentially from $27.2 million, and up from $ million year-earlier.

Royalty revenue was $ million, up sequentially from $20.6 million, and up from $ million year-earlier. Royalties mainly reflect Adcetris sales by Takeda in 67 non-U.S. nations.

E-2 (ECHELON-2) enrollment for MTCL (mature T-cell lymphoma) should have Phase 3 data readouts in Q4 2018.

In collaboration with Bristol-Myers Squibb, a Phase 3 trial to test Adcetris with checkpoint inhibitor Opdivo (nivolumab) in relapsed or refractory HL (Hodgkin lymphoma) was ongoing. Earlier data announced was very positive.

Enfortumab Vedotin (ASG-22ME or EV), in collaboration with Agensys/Astellas, completed enrollment for a cohort of a pivotal Phase 2 trial in metastatic urothelial cancer for patients who already failed a checkpoint inhibitor. A post-CPI setting trial is also planned, as are earlier lines of treatment and combination therapies. Enrollment is expected to complete in Q3 2018. 40% objective response rate reported at ASCO for Phase 1. Granted Breakthrough Therapy Designation. A second Phase 3 trial, EV-301 for patients who received prior CPI, started in Q2 2018.

Seattle Genetics will co-develop tisotumab vedotin (TV) with Genmab, on a 50:50 basis. They now plan a pivotal Phase 2 trial in advanced cervical cancer to begin in 1H 2018. Other Phase 2 trials with tisotumab will try it as part of a combination regimen in front-line cervical cancer and as a monotherapy in other tumor types.

Tucatinib, an oral tyrosine kinase inhibitor, is in a global pivotal trial (HER2CLIMB) for HER2+ metastatic breast cancer. Should be fully enrolled in 2019. SGEN is evaluating expanding development to earlier lines of therapy, other cancers, and in combinations.

GlaxoSmithKline (GSK) yesterday outlined a broad development effort based on Seattle Genetics technology.

A Phase 1 trial of SEA-CD40 for solid tumors continues.

SGN-CD19A or Denintuzumab Mafodotin was discontinued, as were certain similar programs, to focus on more promising programs.

SGN-CD19B continued a Phase 1 trial for relapsed or refractory B-cell non-Hodgkin lymphoma.

SGN-LIV1A Phase 1 data was presented in December showing antitumor activity for heavily pretreated triple-negative breast cancer. An expansion cohort is enrolling, with data to be presented in December. Plans a combination with tecentriq for triple-negative breast cancer, conducted by Roche. Added an agreement with Merck to try with Keytruda.

Collaboration with Genentech/Roche phase 3 trial continued of polatuzumab vedotin for patients with diffuse large B-cell lymphoma.

Tisotumab Vedotin or TV started a pivotal Phase 2 trial for recurrent or metastatic cervical cancer in Q2 2018, as well as a second Phase 2 trial against several types of solid cancers. Could support accelerated approval by FDA. It is being co-developed with Genmab.

Ladiratuzumab Vedotin or LV began a 1b/2 trial for first-line metastatic triple negative breast cancer.

SGN-CD352A continued a Phase 1 trail for multiple myeloma.

SEA-CD40 is a novel immuno-oncology agent targeted to CD40 utilizing Seattle Genetics’ proprietary sugar-engineered antibody (SEA) technology to produce a non-fucosylated antibody. Planning a trial in combination with a checkpoint inhibitor.

SGN-CD123A continued a Phase 1 trial for relapsed/refractory AML. CD123 is expressed on leukemic stem cells, which have proven difficult to kill.

SGN-2FF continued a Phase 1 trial for relapsed or refractory solid tumors.

SGN-CD48A started a Phase 1 trial in for refractory multiple myeloma in Q1.

SGN-BCMA program should enter phase 1 in 2018.

Abbvie's ADC for glioblastoma is now in a Phase 3 trial.

See also Seattle Genetics pipeline.

Cash ended at $ million, sequentially from $458 million. An additonal $208 million was held as stock of Immunomedics (IMMU) and Unum. There was no debt.

Total costs and expenses were $ million, consisting of: cost of sales $ million; cost of royalty revenue $ million, R&D $ million; selling, general and administrative expense $ million. Resulting in a loss from operations of $ million. Other income $ million. Income tax $ million.

Q&A:

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