On April 28, 2016 Seattle Genetics, Inc. (NASDAQ: SGEN) reported financial results for the first quarter ended March 31, 2016 (Press release, Seattle Genetics, APR 28, 2016, View Source;p=RssLanding&cat=news&id=2162985 [SID:1234511558]). The company also highlighted ADCETRIS (brentuximab vedotin) commercialization, regulatory and clinical development accomplishments, vadastuximab talirine (SGN-CD33A; 33A) activities and progress with other proprietary pipeline programs and technologies.
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"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
Achieved a $20 million one-time milestone payment from Takeda Pharmaceutical Company Limited (Takeda) triggered by Takeda surpassing ADCETRIS annual net sales of $200 million in its territory during 2015. The milestone was recognized as royalty revenue in the first quarter of 2016.
Takeda continues to receive additional marketing approvals for ADCETRIS, which is now commercially available in 64 countries worldwide following recent approvals in Russia and Egypt.
Initiated a phase 1/2 clinical trial of 33A in combination with azacitidine for patients with previously untreated myelodysplastic syndrome (MDS). MDS is often a precursor to AML, and both diseases broadly express CD33.
Reported research and preclinical data in multiple sessions at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting highlighting antibody-drug conjugate (ADC) and other innovative targeted therapies, including:
Preclinical data supporting development activities with SGN-LIV1A and SEA-CD40;
Two novel preclinical programs, including an ADC for the treatment of multiple myeloma (SGN-CD352A) and a small molecule that enhances T-cell-mediated antitumor activity (2-fluorofucose; 2FF);
Data showing the ability of auristatin-based ADCs, including ADCETRIS, to initiate immunogenic cell death, supporting evaluation of ADCs in combination with checkpoint inhibitors; and,
A new auristatin-based drug-linker as well as several novel linkers that expand Seattle Genetics’ proprietary ADC technology platform and may enable conjugation with previously inaccessible cytotoxic payloads.
Initiated a phase 1 clinical trial of SGN-CD19B for relapsed or refractory B-cell non-Hodgkin lymphoma, including diffuse large B-cell lymphoma (DLBCL) and grade 3 follicular lymphoma. SGN-CD19B is an anti-CD19 ADC utilizing the same ADC technology as 33A, which includes a highly potent cytotoxic DNA-crosslinking agent called a pyrrolobenzodiazepine (PBD) dimer linked via a proprietary site-specific conjugation technology to a monoclonal antibody with engineered cysteines (EC-mAb).
Generated fees from ongoing ADC collaboration with Genentech upon its extension of the research term and renewal of exclusive licenses to specific ADC targets.
Added to and promoted several members of the senior management team, including:
Promoting Darren Cline to Executive Vice President, Commercial. Mr. Cline has been with Seattle Genetics since November 2010. During his tenure, he has been an integral member of the commercial leadership team, including significant contributions in the successful launch and ongoing commercialization of ADCETRIS in the United States and Canada.
Hiring Brandi Robinson as Senior Vice President, Corporate Communications. Ms. Robinson previously spent four years as Vice President and Head of Communications, North America for Sanofi. Before that, she was at Novartis for more than a decade.
Hiring Christopher Thomson, Ph.D., as Vice President, Commercial Planning. Dr. Thomson will oversee the company’s new European operations. He previously spent eight years at Astellas Pharma Europe, most recently as Vice President, Head of Oncology Business Unit. Prior to that, he spent three years with IMS Health and eight years with Bayer.
Promoting Kristin Rand to Vice President and Compliance Officer. Since joining Seattle Genetics in October 2012, Ms. Rand has grown the company’s compliance program to ensure its integrity, ethics and compliance with applicable laws and regulations.
Anticipated Upcoming Activities
ADCETRIS
Report data in the third quarter of 2016 from the phase 3 ALCANZA trial in patients with relapsed CD30-expressing cutaneous T-cell lymphoma (CTCL).
Report data in the 2017 through mid-2018 timeframe from the phase 3 ECHELON-1 trial in frontline classical Hodgkin lymphoma.
Complete enrollment in the phase 3 ECHELON-2 trial in frontline mature T-cell lymphoma (MTCL) during 2016 and report data in the 2017 to 2018 timeframe.
ADCETRIS is not currently approved for use in CTCL, frontline MTCL or frontline Hodgkin lymphoma.
Vadastuximab Talirine (SGN-CD33A)
Initiate a phase 3 trial to evaluate 33A in combination with hypomethylating agents, or HMAs, in older patients with AML by the third quarter of 2016.
Report additional data from a phase 1 trial of 33A in combination with HMAs at the European Hematology Association (EHA) (Free EHA Whitepaper) annual meeting being held June 9 to 12, 2016 in Copenhagen, Denmark.
Report data in 2016 from a phase 1b trial of 33A in combination with cytarabine and daunorubicin for frontline, younger AML patients.
More information about 33A and ongoing clinical trials can be found at www.ADC-CD33.com.
Additional Pipeline Programs
Initiate a randomized phase 2 trial of denintuzumab mafodotin (SGN-CD19A; 19A) in frontline DLBCL in the first half of 2016.
Report phase 1 clinical data from ASG-15ME and ASG-22ME at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting being held June 3 to 7, 2016 in Chicago, Illinois. These programs are in development for solid tumors, notably bladder cancer, under a 50:50 co-development collaboration with Astellas.
Initiate a phase 1 trial of SGN-CD123A in AML during 2016.
Advance SGN-CD352A, a novel ADC for multiple myeloma, into a phase 1 clinical trial. Preclinical data were reported at AACR (Free AACR Whitepaper) on this novel ADC, which is composed of an anti-CD352 antibody utilizing the company’s PBD and EC-mAb technology.
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:
ADCETRIS net product sales of $58.6 million, a 20 percent increase from net product sales of $48.9 million for the first quarter of 2015.
Royalty revenues of $32.3 million on international sales of ADCETRIS by Takeda, compared to $11.1 million for the same period in 2015. First quarter 2016 royalty revenues included a $20 million one-time milestone payment triggered by Takeda surpassing ADCETRIS annual net sales of $200 million in its territory during 2015.
Amounts earned under the company’s ADCETRIS and ADC collaborations totaling $20.2 million in the first quarter of 2016, compared to $22.2 million in the first quarter of 2015.
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.