-ADCETRIS® (Brentuximab Vedotin) Net Sales in U.S. and Canada of $127.0 Million in the Third Quarter-
-Positive Top-line Data from ADCETRIS Phase 3 ECHELON-2 Trial in Frontline PTCL; Supplemental BLA Planned for November 2018; Full Data to be Presented at ASH Annual Meeting-
-Top-line Data from Enfortumab Vedotin Pivotal Trial in Metastatic Urothelial Cancer Expected in the First Quarter of 2019-
-Conference Call Today at 4:30 p.m. ET-
Seattle Genetics, Inc. (Nasdaq:SGEN) today reported financial results for the third quarter and nine months ended September 30, 2018. The company also highlighted ADCETRIS (brentuximab vedotin) commercialization and clinical development accomplishments and progress with its late-stage clinical programs for cancer.
“ADCETRIS net sales during the third quarter and year-to-date increased by more than 50 percent over the same periods in 2017, as we continue to expand into the frontline Hodgkin lymphoma setting following FDA approval earlier this year. In addition, we recently reported positive top-line results from the phase 3 ECHELON-2 trial in frontline peripheral T-cell lymphoma, including a statistically significant improvement in overall survival for the ADCETRIS regimen,” said Clay Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. “We plan to submit an application for approval to the FDA in November and look forward to highlighting results from ECHELON-2 at the American Society of Hematology Annual Meeting in December. Our late-stage programs continue to progress, and we believe they have the potential to transform Seattle Genetics into a multi-product oncology company. We now plan to report top-line results from the pivotal trial of enfortumab vedotin in metastatic urothelial cancer in the first quarter of 2019. Additionally, we expect to complete enrollment of 480 patients in the HER2CLIMB pivotal trial of tucatinib in metastatic breast cancer in early 2019 to support analysis of the primary endpoint.”
ADCETRIS Program Highlights
ADCETRIS is not currently approved for use in frontline PTCL or in combination with nivolumab.
Enfortumab Vedotin (EV) Program Highlights
Tucatinib Program Highlights
Tisotumab Vedotin (TV) Program Highlights
THIRD QUARTER AND NINE MONTHS 2018 FINANCIAL RESULTS
Revenues: Total revenues in the third quarter and nine month periods ended September 30, 2018 increased to $169.4 million and $480.2 million, respectively, compared to $135.3 million and $352.6 million for the same periods in 2017. Revenues are comprised of the following three components:
Research and Development (R&D) Expenses: R&D expenses in the third quarter were $140.2 million, compared to $113.6 million in the third quarter of 2017. R&D expenses were $415.5 million for the year-to-date in 2018, compared to $346.2 million for the same period in 2017. The increase for the year-to-date period reflects $35.0 million in upfront costs in the first quarter of 2018 related to technology licensing agreements in addition to increased investment in the company’s pipeline programs.
Selling, general and administrative (SG&A) Expenses: SG&A expenses in the third quarter were $57.2 million, compared to $39.7 million in the third quarter of 2017. SG&A expenses were $181.6 million for the year-to-date in 2018, compared to $118.8 million for the same period 2017. The increase for the year-to-date period was primarily attributed to costs to support the launch of ADCETRIS in frontline Hodgkin lymphoma and transaction costs associated with the acquisition of Cascadian Therapeutics.
Non-cash, share-based compensation cost for the first nine months of 2018 was $53.2 million, compared to $47.9 million for the same period in 2017.
Net Income (Loss)
Net loss for the third quarter of 2018 was $67.4 million, or $0.42 per diluted share, compared to net income of $50.0 million, or $0.34 per diluted share, for the third quarter of 2017. Net loss in the third quarter of 2018 includes a net investment loss of $23.8 million primarily associated with Seattle Genetics’ common stock holdings in Immunomedics, which are marked-to-market. For the nine months ended September 30, 2018, net loss was $102.9 million, or $0.66 per share, compared to a net loss of $66.3 million, or $0.46 per share, for the nine months ended September 30, 2017. Net loss for the year-to-date in 2018 includes a net investment gain of $62.9 million primarily associated with Seattle Genetics’ common stock holdings in Immunomedics.
Cash and Investments
As of September 30, 2018, Seattle Genetics had $485.7 million in cash and investments. In addition, the company held stock investments, primarily in Immunomedics common stock, valued at $169.4 million.
2018 FINANCIAL GUIDANCE
The company's 2018 financial guidance is detailed below.
| Current | Previous | ||||||
| Fourth Quarter | |||||||
| ADCETRIS net product sales | $128 million to $133 million | None provided | |||||
| Full Year | |||||||
| ADCETRIS net product sales | $473 million to $478 million | None provided | |||||
| Collaboration and license agreement revenues | $80 million to $90 million | $65 million to $75 million | |||||
| Royalty revenues | $78 million to $82 million | $75 million to $80 million | |||||
| R&D expenses | $555 million to $575 million | $530 million to $580 million | |||||
| SG&A expenses | $240 million to $250 million | $220 million to $240 million | |||||
Conference Call Details
Seattle Genetics’ management will host a conference call and webcast to discuss its third quarter 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 877-260-1479 (domestic) or 334-323-0522 (international). The conference ID is 3537888. A replay of the discussion will be available on October 25, 2018 from the Seattle Genetics website or by calling 888-203-1112 (domestic) or 719-457-0820 (international), using conference ID 3537888. The telephone replay will be available until 5:00 p.m. PT on Monday, October 29, 2018.
About Seattle Genetics
Seattle Genetics, Inc. is an emerging multi-product, global biotechnology company that develops and commercializes transformative therapies targeting cancer to make a meaningful difference in people’s lives. ADCETRIS® (brentuximab vedotin) utilizes the company’s industry-leading antibody-drug conjugate (ADC) technology and is currently approved for the treatment of multiple CD30-expressing lymphomas. Beyond ADCETRIS, the company has established a pipeline of novel targeted therapies at various stages of clinical testing, including three in ongoing pivotal trials for solid tumors. Enfortumab vedotin for metastatic urothelial cancer and tisotumab vedotin for metastatic cervical cancer utilize our proprietary ADC technology. Tucatinib, a small molecule tyrosine kinase inhibitor, is in a pivotal trial for HER2-positive metastatic breast cancer. In addition, we are leveraging our expertise in empowered antibodies to build a portfolio of proprietary immuno-oncology agents in clinical trials targeting hematologic malignancies and solid tumors. The company is headquartered in Bothell, Washington, and has a European office in Switzerland. For more information on our robust pipeline, visit www.seattlegenetics.com and follow @SeattleGenetics on Twitter.
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 2018 outlook, including anticipated fourth quarter ADCETRIS net sales and full year ADCETRIS net sales, revenues and expenses; the company’s potential to achieve the noted development and regulatory milestones in 2018 and in future periods and to otherwise offer multiple transformative therapies including the submission of a supplemental Biologics License Application (BLA) to the FDA for approval of ADCETRIS in frontline CD30-expressing PTCL in November 2018; anticipated activities related to the company’s planned and ongoing clinical trials, including clinical trial initiation, enrollment and data availability and the expected timing thereof, including with respect to EV-201, HER2CLIMB and other clinical trials; the potential for the company’s clinical trials to support further development, regulatory submissions and potential marketing approvals; the opportunities for, and the therapeutic and commercial potential of ADCETRIS, enfortumab vedotin, tucatinib, and tisotumab vedotin and the company’s other product candidates and those of its licensees and collaborators; anticipated presentations at scientific conferences; 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 the company’s ADCETRIS net sales, revenue, expense, and other financial guidance may not be as expected, as well as risks and uncertainties associated with maintaining or increasing sales of ADCETRIS due to competition, unexpected adverse events, regulatory action, reimbursement, or market adoption by physicians. The company may also be delayed in its planned clinical trial initiations, the enrollment in and conduct of its clinical trials, obtaining data from clinical trials, planned regulatory submissions, and regulatory approvals 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 and the inherent uncertainty associated with the regulatory approval process. The company may also be unable to expand ADCETRIS’ labeled indications due to unexpected, negative or delayed regulatory action, and that supplemental BLA submission based on ECHELON-2 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, and the company may be unable to complete the development of, and obtain regulatory approval for, any of 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 June 30, 2018 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 except as required by applicable law.
| Seattle Genetics, Inc. | |||||||||||||||||
| Condensed Consolidated Statements of Operations | |||||||||||||||||
| (Unaudited) | |||||||||||||||||
| (In thousands, except per share amounts) | |||||||||||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||
| 2018 | 2017 | 2018 | 2017 | ||||||||||||||
| Revenues: | |||||||||||||||||
| Net product sales | $ | 126,976 | $ | 79,177 | $ | 344,776 | $ | 223,841 | |||||||||
| Collaboration and license agreement revenues | 19,786 | 39,444 | 76,524 | 82,779 | |||||||||||||
| Royalty revenues | 22,662 | 16,670 | 58,887 | 46,025 | |||||||||||||
| Total revenues | 169,424 | 135,291 | 480,187 | 352,645 | |||||||||||||
| Costs and expenses: | |||||||||||||||||
| Cost of sales | 12,348 | 9,019 | 35,863 | 24,555 | |||||||||||||
| Cost of royalty revenues | 5,320 | 5,196 | 16,845 | 13,900 | |||||||||||||
| Research and development | 140,175 | 113,606 | 415,537 | 346,196 | |||||||||||||
| Selling, general and administrative | 57,155 | 39,667 | 181,629 | 118,783 | |||||||||||||
| Total costs and expenses | 214,998 | 167,488 | 649,874 | 503,434 | |||||||||||||
| Loss from operations | (45,574 | ) | (32,197 | ) | (169,687 | ) | (150,789 | ) | |||||||||
| Investment and other income (loss), net | (21,872 | ) | 82,218 | 66,799 | 84,460 | ||||||||||||
| Net income (loss) | $ | (67,446 | ) | $ | 50,021 | $ | (102,888 | ) | $ | (66,329 | ) | ||||||
| Net income (loss) per share - basic | $ | (0.42 | ) | $ | 0.35 | $ | (0.66 | ) | $ | (0.46 | ) | ||||||
| Net income (loss) per share - diluted | $ | (0.42 | ) | $ | 0.34 | $ | (0.66 | ) | $ | (0.46 | ) | ||||||
| Shares used in computation of per share amounts - basic | 159,304 | 143,357 | 156,799 | 142,876 | |||||||||||||
| Shares used in computation of per share amounts - diluted | 159,304 | 148,068 | 156,799 | 142,876 | |||||||||||||
| Seattle Genetics, Inc. | ||||||||
| Condensed Consolidated Balance Sheets | ||||||||
| (Unaudited) | ||||||||
| (In thousands) | ||||||||
| September 30, 2018 | December 31, 2017 | |||||||
| Assets | ||||||||
| Cash, cash equivalents and investments | $ | 485,711 | $ | 413,171 | ||||
| Other assets | 1,082,134 | 464,778 | ||||||
| Total assets | $ | 1,567,845 | $ | 877,949 | ||||
| Liabilities and Stockholders’ Equity | ||||||||
| Accounts payable and accrued liabilities | $ | 157,157 | $ | 132,672 | ||||
| Deferred revenue and long-term liabilities | 46,167 | 67,708 | ||||||
| Stockholders’ equity | 1,364,521 | 677,569 | ||||||
| Total liabilities and stockholders’ equity | $ | 1,567,845 | $ | 877,949 | ||||
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Seattle Genetics, Inc.
Investors:
Peggy Pinkston, 425-527-4160
ppinkston@seagen.com
or
Media:
Monique
Greer, 425-527-4641
mgreer@seagen.com