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Seattle Genetics Reports First Quarter 2016 Financial ResultsSeattle Genetics, Inc. (NASDAQ: SGEN) today reported financial results for the first quarter ended March 31, 2016. The company also highlighted ADCETRIS (brentuximab vedotin) commercialization, regulatory and clinical development accomplishments, vadastuximab talirine (SGN (News - Alert)-CD33A; 33A) activities and progress with other proprietary pipeline programs and technologies. "In the first quarter, ADCETRIS net sales increased 20 percent compared to the first quarter of 2015, and we are completing three ongoing phase 3 trials designed to support additional label expansions. We expect top-line data from the first of these trials, ALCANZA, in the third quarter of this year, followed by ECHELON-1 in the 2017 to mid-2018 timeframe and ECHELON-2 in the 2017 to 2018 timeframe," said Clay Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. "With our pipeline, we remain on track to advance 33A into a phase 3 trial in acute myeloid leukemia (AML) by the third quarter, and we expect to report data from multiple programs over the course of 2016. Our strong financial position of more than $690 million in cash and investments at the end of March, and no debt, enables us to continue investing in our substantial opportunities to help people with cancer." Recent ADCETRIS, Pipeline and Other Corporate Highlights
Anticipated Upcoming Activities ADCETRIS
ADCETRIS is not currently approved for use in CTCL, frontline MTCL or frontline Hodgkin lymphoma. Vadastuximab Talirine (SGN-CD33A)
More information about 33A and ongoing clinical trials can be found at www.ADC-CD33.com. Additional Pipeline Programs
First Quarter 2016 Financial Results Total revenues in the first quarter of 2016 were a record $111.2 million, an increase of 35 percent over first quarter 2015 revenues of $82.2 million. Revenues in the first quarter of 2016 included:
Total costs and expenses for the first quarter of 2016 were $132.2 million, compared to $103.9 million for the first quarter of 2015. The planned increase in 2016 costs and expenses was primarily related to progress with ADCETRIS and investment in the company's pipeline programs, including expanded 33A clinical development and manufacturing activities. Non-cash, share-based compensation cost for the first quarter of 2016 was $12.2 million, compared to $7.7 million for the first quarter of 2015. Net loss for the first quarter of 2016 was $20.5 million, or $0.15 per share, compared to a net loss of $21.7 million, or $0.17 per share, for the first quarter of 2015. As of March 31, 2016, Seattle Genetics had $691.7 million in cash, cash equivalents and investments, compared to $712.7 million as of December 31, 2015. Conference Call Details Seattle Genetics' management will host a conference call and webcast to discuss the financial results and provide an update on business activities. The event will be held today at 1:30 p.m. Pacific Time (PT); 4:30 p.m. Eastern Time (ET). The live event will be available from Seattle Genetics' website at www.seattlegenetics.com, under the Investors and News section, or by calling 800-499-4035 (domestic) or 416-204-9269 (international). The conference ID is 4267568. A replay of the discussion will be available beginning at approximately 4:30 p.m. PT today from Seattle Genetics' website or by calling 888-203-1112 (domestic) or 719-457-0820 (international), using conference ID 4267568. The telephone replay will be available until 5:00 p.m. PT on Monday, May 2, 2016. About Seattle Genetics Seattle Genetics is a biotechnology company focused on the development and commercialization of innovative antibody-based therapies for the treatment of cancer. Seattle Genetics is leading the field in developing antibody-drug conjugates (ADCs), a technology designed to harness the targeting ability of antibodies to deliver cell-killing agents directly to cancer cells. The company's lead product, ADCETRIS® (brentuximab vedotin), is a CD30-targeted ADC that, in collaboration with Takeda Pharmaceutical Company Limited, is commercially available in more than 60 countries, including the U.S., Canada, Japan and members of the European Union. Additionally, ADCETRIS is being evaluated broadly in more than 70 ongoing clinical trials in CD30-expressing malignancies. Seattle Genetics is also advancing vadastuximab talirine (SGN-CD33A; 33A), an ADC that is expected to advance into a phase 3 trial for acute myeloid leukemia in 2016. Beyond ADCETRIS and 33A, the company is developing a robust pipeline of clinical-stage programs, including denintuzumab mafodotin (SGN-CD19A; 19A), SGN-LIV1A, ASG-15ME, ASG-22ME, SGN-CD70A, SEA-CD40 and SGN-CD19B. Seattle Genetics has collaborations for its ADC technology with a number of leading biotechnology and pharmaceutical companies, including AbbVie, Agensys (an affiliate of Astellas), Bayer, Genentech, GlaxoSmithKline and Pfizer. More information can be found at www.seattlegenetics.com. Forward-Looking Statements Certain of the statements made in this press release are forward looking, such as those, among others, relating to the company's expectations for 2016 ADCETRIS net sales, anticipated financial outlook including revenues, costs and expenses, upcoming presentations and publications, anticipated regulatory events and clinical activities, including enrollment completion and data availability from ALCANZA, ECHELON-1 and ECHELON-2 and other ongoing clinical trials and the timing thereof, and the initiation of future clinical trials including a registrational trial for 33A, the opportunities for, and the therapeutic and commercial potential of, ADCETRIS, 33A and the company's other product candidates, as well as other statements that are not historical facts. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include the risk that sales of ADCETRIS may not meet or exceed our guidance or otherwise be as we expect, including, with respect to the company's 2016 ADCETRIS net sales and financial guidance as well as other risks related to future opportunities and plans, including the uncertainty of expected future financial performance and results. We may also be delayed in our planned clinical trial initiations, the enrollment in and conduct of our clinical trials, and obtaining data from clinical trials, in each case for a variety of reasons, including the difficulty and uncertainty of pharmaceutical product development and unexpected adverse events or regulatory action. We may also be unable to expand ADCETRIS' labeled indications due to unexpected data from our ongoing phase 3 trials or regulatory action or complete the development of, and obtain regulatory approval for, our product candidates, each of which are in relatively early stages of development. More information about the risks and uncertainties faced by Seattle Genetics is contained under the caption "Risk Factors" included in the company's Annual Report on Form 10-K for the year ended December 31, 2015 filed with the Securities and Exchange Commission. Seattle Genetics disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
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