Report
Karen Andersen
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Morningstar | Seattle Genetics Submits Enfortumab Vedotin for FDA Approval; Solid Adcetris Sales in 2Q

Seattle Genetics reported revenue of $218 million, up 28% from last year. Adcetris sales of $159 million in the U.S. and Canada were up 30% from last year and 17% sequentially, which represents solid growth that helps offset the company's weaker first quarter. Adcetris, which is used to treat classical Hodgkin's lymphoma and anaplastic large cell lymphoma, remains the company's key driver, and we anticipate steady double-digit growth for the next several years due to Adcetris' solid efficacy and high unmet need in lymphoma. Additionally, royalty revenue from Seattle's agreement with Takeda to sell Adcetris globally continues to grow with new international approvals. Royalty revenues totaled $23.3 million, up 13% from last year and 48% sequentially.

Management's full-year guidance remains largely unchanged, aside from slightly higher collaboration revenue and higher selling, general, and administrative costs due to the filing and potential launch of enfortumab vedotin. We are maintaining our fair value estimate of $65 per share for no-moat Seattle following the company's second-quarter results.

Seattle Genetics, along with partner Astellas Pharma, announced the submission of enfortumab vedotin for FDA approval in second-line bladder cancer, based on a phase 2 trial that read out at a medical conference in June. This potential approval would limit the patient population to those who have received a PD-1 or PD-L1 inhibitor and have undergone chemotherapy treatment. Approval in first-line treatment, which would be supported by an ongoing early-stage clinical trial, EV-103, would significantly expand the eligible population.

Seattle's other pipeline candidates include tucatinib for HER2-positive breast cancer, for which we expect pivotal trial data later this year, and tisotumab vedotin for cervical cancer, for which we expect pivotal trial data in the first half of 2020.
Underlying
Seagen Inc.

Seattle Genetics is a biotechnology company that develops and commercializes therapies targeting cancer. The company is commercializing ADCETRIS?, or brentuximab vedotin, for the treatment of several types of lymphoma. The company is also developing a pipeline of therapies for solid tumors and blood-related cancers designed to address unmet medical needs and improve treatment outcomes for patients. Many of the company's programs, including ADCETRIS, are based on its antibody-drug conjugate (ADC), technology. The company's late-stage pipeline includes two ADCs and an oral tyrosine kinase inhibitor, for solid tumors that are in clinical trials designed to support applications for potential regulatory approvals.

Provider
Morningstar
Morningstar

Morningstar, Inc. is a leading provider of independent investment research in North America, Europe, Australia, and Asia. The company offer an extensive line of products and services for individual investors, financial advisors, asset managers, and retirement plan providers and sponsors.

Morningstar provides data on approximately 530,000 investment offerings, including stocks, mutual funds, and similar vehicles, along with real-time global market data on more than 18 million equities, indexes, futures, options, commodities, and precious metals, in addition to foreign exchange and Treasury markets. Morningstar also offers investment management services through its investment advisory subsidiaries and had approximately $185 billion in assets under advisement and management as of June 30, 2016.

We have operations in 27 countries.

Analysts
Karen Andersen

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