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Seattle Genetics Reports Second Quarter 2017 Financial ResultsSeattle Genetics, Inc. (NASDAQ: SGEN) today reported financial results for the second quarter ended June 30, 2017. The company also highlighted ADCETRIS (brentuximab vedotin) commercialization and clinical development accomplishments, enfortumab vedotin (ASG-22ME) clinical activities, as well as progress with its pipeline of antibody-drug conjugates (ADCs) and other proprietary programs. "During the second quarter, we delivered record ADCETRIS revenues and achieved three key development milestones for the program: reporting positive top-line data from the ECHELON-1 trial in frontline advanced classical Hodgkin lymphoma, submitting an application for approval to the FDA for cutaneous T-cell lymphoma, and entering into a clinical collaboration agreement with Bristol-Myers Squibb for an additional pivotal trial in relapsed/refractory Hodgkin lymphoma," said Clay Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. "Over the remainder of 2017, our key activities will include reporting full data from the ECHELON-1 trial planned at the American Society of Hematology annual meeting in December, submitting a supplemental Biologics License Application to the FDA based on the ECHELON-1 data, and initiating a pivotal trial of enfortumab vedotin in metastatic urothelial cancer under our collaboration with Astellas." ADCETRIS Program Highlights
ADCETRIS is not currently approved for use in CTCL, frontline Hodgkin lymphoma, frontline MTCL or in combination with nivolumab. Enfortumab Vedotin Program Highlights
Other Recent Activities
Second Quarter and Six Months 2017 Financial Results Total revenues in the second quarter and six month periods ended June 30, 2017 increased to $108.2 million and $217.4 million, respectively, compared to $95.4 million and $206.6 million from the same periods in 2016. Revenues included:
Total costs and expenses for the second quarter of 2017 were $167.5 million, compared to $128.8 million for the second quarter of 2016. For the first six months of 2017, total costs and expenses were $336.0 million, compared to $261.0 million in the first six months of 2016. The increase in 2017 costs and expenses was primarily driven by investment in enfortumab vedotin, vadastuximab talirine, ADCETRIS and the company's pipeline programs. Non-cash, share-based compensation cost for the first six months of 2017 was $32.0 million, compared to $24.3 million for the same period in 2016. Net loss for the second quarter of 2017 was $56.4 million, or $0.39 per share, compared to a net loss of $32.7 million, or $0.23 per share, for the second quarter of 2016. For the six months ended June 30, 2017, net loss was $116.4 million, or $0.82 per share, compared to a net loss of $53.2 million, or $0.38 per share, for the six months period ended June 30, 2016. As of June 30, 2017, Seattle Genetics had $473.0 million in cash, cash equivalents and investments. 2017 Financial Outlook Seattle Genetics increased its expectations for 2017 ADCETRIS net product sales in the U.S. and Canada to a range of $290 million to $310 million. Conference Call Details Seattle Genetics' management will host a conference call and webcast to discuss its second quarter 2017 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 the Seattle Genetics website at www.seattlegenetics.com, under the Investors section, or by calling 877-874-1568 (domestic) or 719-325-2484 (international). The conference ID is 4818690. A replay of the discussion will be available beginning at approximately 4:30 p.m. PT today from the Seattle Genetics website or by calling 888-203-1112 (domestic) or 719-457-0820 (international), using conference ID 4818690. The telephone replay will be available until 5:00 p.m. PT on Monday, July 31, 2017. About Seattle Genetics Seattle Genetics is an innovative biotechnology company that develops and commercializes novel antibody-based therapies for the treatment of cancer. The company's industry-leading antibody-drug conjugate (ADC) technology harnesses the targeting ability of antibodies to deliver cell-killing agents directly to cancer cells. ADCETRIS® (brentuximab vedotin), the company's lead product, in collaboration with Takeda Pharmaceutical Company Limited, is the first in a new class of ADCs commercially available globally in 67 countries for relapsed classical Hodgkin lymphoma and relapsed systemic anaplastic large cell lymphoma (sALCL). Seattle Genetics is also advancing enfortumab vedotin, an ADC for metastatic urothelial cancer, in a planned pivotal trial in collaboration with Astellas. Headquartered in Bothell, Washington, Seattle Genetics has a strong pipeline of innovative therapies for blood-related cancers and solid tumors designed to address significant unmet medical needs and improve treatment outcomes for patients. The company has collaborations for its proprietary ADC technology with a number of companies including AbbVie, Astellas, Bayer, Celldex, 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 2017 outlook, including anticipated 2017 revenues, costs and expenses; the company's potential to achieve a series of regulatory and commercial milestones in 2017 and 2018; anticipated regulatory events and clinical activities, including data availability from ECHELON-2 and discussions with the FDA regarding ECHELON-2, as well as other ongoing clinical trials, including the CHECKMATE 812 trial, and the timing thereof; the anticipated submission of a supplemental BLA for label expansion of ADCETRIS in frontline Hodgkin lymphoma and the timing thereof and other anticipated regulatory milestones, including any action by the FDA with respect to the supplemental BLA submitted for label expansion of ADCETRIS in CTCL; our plan to advance enfortumab vedotin into a potentially pivotal trial; the opportunities for, and the therapeutic and commercial potential of, ADCETRIS, enfortumab vedotin, SGN-LIV1A 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 risks that revenues may not meet or exceed the company's guidance or otherwise be as the company expects, including, with respect to the company's 2017 ADCETRIS net sales and financial guidance as well as other risks related to financial guidance and future opportunities and plans, including the uncertainty of expected future financial performance and results. The company may also be delayed in its planned clinical trial initiations, the enrollment in and conduct of its clinical trials, and obtaining data from clinical trials, and planned regulatory submissions in each case for a variety of reasons, including the difficulty and uncertainty of pharmaceutical product development, unexpected adverse events or regulatory discussions or actions, including with respect to special protocol assessment agreements defining trial endpoints and the inherent uncertainty associated with the regulatory approval process, including the risks that the company's supplemental BLA submissions may not be accepted for filing by, or ultimately approved by, the FDA in a timely manner or at all or with the requested label. The company may also be unable to expand ADCETRIS' labeled indications due to unexpected or delayed data from its ongoing phase 3 trials or regulatory action, or to complete the development of, and obtain regulatory approval for, its product candidates. More information about the risks and uncertainties faced by Seattle Genetics is contained under the caption "Risk Factors" included in the company's Quarterly Report on Form 10-Q for the quarter ended March 31, 2017 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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