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first_imgLocal News Twitter Pinterest Facebook WhatsApp By Digital AIM Web Support – December 21, 2020 WhatsApp Higher education board awards $18.1 million in reskilling grantscenter_img The Texas Higher Education Coordinating Board has awarded $18.1 million to Texas higher education institutions as part of the first round of awards under the Texas Reskilling Support Fund Grant Program.  Odessa College was awarded $1.5 million. Through a competitive process, 40 applicants representing 49 institutions were selected for the awards, a news release said. Reskilling grants will allow Texas public colleges, technical schools, and universities to provide financial assistance to Texas students to cover tuition and fees. The grants are designed to support displaced Texas workers who need to reskill or upskill to get back into the workforce, and to support students who have previously stopped out of higher education complete a postsecondary credential. The program is supported by a portion of the $175 million allocation to the THECB from the Governor’s Emergency Education Relief Fund. To further its commitment to workforce education, the Coordinating Board welcomed Tina Marie Jackson as its new assistant commissioner of workforce education. The release said Jackson will work on all aspects of career and technical workforce initiatives and programs, including administration of the Carl D. Perkins Career and Technical Education Act. Dr. Jackson’s previous roles include district director of developmental education at Collin College, statewide coordinator of community college programs at The University of Texas at Austin, and associate dean of science, technology, engineering, & math (STEM) at Dallas College. Jackson will oversee the THECB reskilling initiative as the agency launches its second-round request for applications for the grant program. Applications opened Friday and are due by Jan. 15, 2021. Texas public community colleges and universities are encouraged to apply, and institutions that received funding through the first round of grant funding are eligible to apply for round two funding. Pinterest Twitter Facebook TAGS  Previous articleChevron donates $150K to Permian Basin Area Foundation’s Emergency Relief FundNext articleJP says complaint unfoundedLange disputes homebuilder’s allegation of his inaccessibility Digital AIM Web Supportlast_img read more

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first_img $ Exelixis Announces Fourth Quarter and Full Year 2020 Financial Results and Provides Corporate Update 37,228 Stock-based compensation – research and development expenses (1) Twitter 36,272 $ $ 987,538 ) ) License revenues Facebook (unaudited) 0.09 Basic $ 1.16 868,444 20% – 22% Cash and investments (3) (in thousands) (1) ———————————————————— $ 200,353 Income from operations $ 3,489 EXELIXIS, INC. 7,064 759,950 130,837 Three Months Ended December 31, Year Ended December 31, 2020 WhatsApp 162,994 $ Revenues: 1,388,628 310,774 Net income $ 28,388 $ Includes $60 million of non-cash stock-based compensation expense. $ $ 2019 0.36 0.09 Pinterest 165,914 81,031 15,722 $ 33,097 $ 67,872 0.14 $ 369,470 $ By Digital AIM Web Support – March 4, 2021 Cost of goods sold $1.6 billion – $1.7 billion 10,520 (in thousands, except per share amounts) 78,693 315,009 2020 111,781 547,851 58,026 EXELIXIS, INC. 302,584 GAAP net income 293,355 $ 10,226 Local News $ December 31, 2020 2020 (3) 24,297 0.09 27,959 85,014 598,305 0.61 Diluted Total revenues Non-GAAP net income per share: 2,137,333 33,471 0.63 ) 912 $375 million – $425 million View source version on businesswire.com:https://www.businesswire.com/news/home/20210210005909/en/ CONTACT: Chris Senner Chief Financial Officer Exelixis, Inc. 650-837-7240 [email protected] Hubbard EVP, Public Affairs & Investor Relations Exelixis, Inc. 650-837-8194 [email protected] KEYWORD: UNITED STATES NORTH AMERICA CALIFORNIA INDUSTRY KEYWORD: ONCOLOGY HEALTH GENETICS CLINICAL TRIALS PHARMACEUTICAL BIOTECHNOLOGY SOURCE: Exelixis, Inc. Copyright Business Wire 2021. PUB: 02/10/2021 04:05 PM/DISC: 02/10/2021 04:05 PM http://www.businesswire.com/news/home/20210210005909/en Non-cash stock-based compensation expense used for GAAP reporting in accordance with Accounting Standards Codification Topic 718, Compensation—Stock Compensation. 2020 5,629 Net product revenues Provision for (benefit from) income taxes 37,198 $ Research and development expenses (1) 19,056 321,012 0.36 $ $ $ 77,097 WhatsApp 111,781 Year Ended December 31, 12,215 0.22 Basic 2019 $ 364,899 341 Income tax effect of the above adjustments Cash and investments 28,127 Effective tax rate Diluted 154,279 $ 1.02 270,052 ) Diluted $ $ 82,439 Basic 2019center_img 110,060 228,244 Weighted-average common shares outstanding: Cabozantinib Highlights Cabozantinib Franchise Net Product Revenues and Royalties. Net product revenues generated by the cabozantinib franchise in the U.S. were $200.4 million during the fourth quarter of 2020, with net product revenues of $196.3 million from CABOMETYX ® (cabozantinib) and $4.0 million from COMETRIQ ® (cabozantinib). For the year ended December 31, 2020, net product revenues generated by the cabozantinib franchise in the U.S. were $741.6 million, with net product revenues of $718.7 million from CABOMETYX and $22.9 million from COMETRIQ. Based upon cabozantinib-related revenues generated by Exelixis’ collaboration partners during the quarter and year ended December 31, 2020, Exelixis earned $23.3 million and $78.4 million, respectively, in royalty revenues. In 2020, global cabozantinib franchise net revenue generated by Exelixis and its partners exceeded $1.0 billion. U.S. Food and Drug Administration (FDA) Approves CABOMETYX in Combination with OPDIVO ® (nivolumab) for Advanced Renal Cell Carcinoma (RCC). In January 2021, Exelixis announced that the FDA approved its supplemental New Drug Application (sNDA) for CABOMETYX in combination with Bristol Myers Squibb’s (BMS) OPDIVO as a first-line treatment of patients with advanced RCC. The approval is based on positive results of the CheckMate -9ER phase 3 pivotal trial, which met its primary endpoint of significantly improving progression-free survival (PFS) and secondary endpoints of overall survival and objective response rate. Exelixis announced the submission of this sNDA in August 2020. In October 2020, the FDA accepted the filing, granting the application Priority Review designation. Supplemental Applications Submitted for CABOMETYX in Combination with OPDIVO in European Union and Japan for the Treatment of Advanced Metastatic RCC. In September 2020, Exelixis announced that its collaboration partner Ipsen and BMS had each submitted type II variation applications for CABOMETYX in combination with OPDIVO for the treatment of metastatic RCC to the European Medicines Agency (EMA), which was validated by the EMA on September 12, 2020. In October 2020, Exelixis announced that its collaboration partner Takeda, along with Ono Pharmaceuticals Co., Ltd., submitted a supplemental application to the Japanese Ministry of Health, Labour and Welfare (MHLW) for Manufacturing and Marketing Approval of CABOMETYX in combination with OPDIVO for the treatment of patients with unresectable, advanced or metastatic RCC. Both applications are also based on the results from the CheckMate -9ER study. Exelixis’ Partner Takeda Receives Approval in Japan for CABOMETYX for the Treatment of Unresectable Hepatocellular Carcinoma (HCC) That Has Progressed After Prior Cancer Chemotherapy. In November 2020, Exelixis announced that its collaboration partner Takeda received approval from the Japanese MHLW to manufacture and market CABOMETYX as a treatment for patients with unresectable HCC that has progressed after prior cancer chemotherapy. Takeda’s application was based on the results of two clinical trials in patients with advanced HCC who had received prior systemic therapy: CELESTIAL, a global, randomized, placebo-controlled, double-blind phase 3 clinical trial; and Cabozantinib-2003, a phase 2 clinical bridging trial conducted in Japan. Exelixis received a $15.0 million milestone payment from Takeda upon the first commercial sale of CABOMETYX for unresectable HCC, which occurred in the fourth quarter of 2020. Announcement of Top-line Results from Pivotal Phase 3 COSMIC-311 Trial of Cabozantinib in Patients with Previously Treated Radioiodine (RAI)-Refractory Differentiated Thyroid Cancer (DTC). In December 2020, Exelixis announced that COSMIC-311, the phase 3 pivotal trial evaluating cabozantinib versus placebo in patients with RAI-refractory DTC who have progressed after up to two prior vascular endothelial growth factor receptor-targeted therapies, met the co-primary endpoint of demonstrating significant improvement in PFS with a hazard ratio of 0.22 (96% confidence interval 0.13 – 0.36; p<0.0001). Based on these positive results, Exelixis intends to file an sNDA for cabozantinib monotherapy in a DTC indication in 2021. Cabozantinib Data at the 2021 American Society of Clinical Oncology’s Genitourinary Cancers Symposium (ASCO GU 2021). Later this week, cabozantinib will be the subject of multiple data presentations at ASCO GU 2021, which is being held virtually from February 11-13. Planned presentations include: updated trial results with extended follow-up and patient-reported outcomes from the CheckMate -9ER trial; results from the SWOG S1500 trial (“PAPMET”) of cabozantinib versus sunitinib in metastatic papillary RCC; data from an international study of cabozantinib in RCC patients with brain metastases; and final data from the phase 1 trial, including seven expansion cohorts, evaluating cabozantinib in combination with either nivolumab or nivolumab plus ipilimumab in patients with refractory metastatic genitourinary tumors. Pipeline Highlights Presentations of Data for XL092 and AUR102 at the 32 nd EORTC-NCI-AACR (ENA) Symposium on Molecular Targets and Cancer Therapeutics. In October 2020, Exelixis presented the preclinical profile and initial clinical pharmacokinetics (PK) for XL092 at the ENA Symposium. The poster discussion presentation included preclinical results demonstrating robust target and tumor growth inhibition, as well as increased efficacy for XL092 when combined with an immune checkpoint inhibitor (ICI). PK data from the ongoing phase 1 trial suggested a significantly shorter PK half-life for XL092 as compared to cabozantinib. Also at the ENA Symposium, Aurigene Discovery Technologies Limited (Aurigene) presented promising preclinical data for AUR102, its novel inhibitor of cyclin-dependent kinase 7 (CDK7), including potent anti-tumor activity in a large panel of cancer cell lines. In December 2020, Exelixis in-licensed AUR102; now known as XL102, the compound is the subject of an active Investigational New Drug application (IND) and an ongoing phase 1 clinical trial. Enrollment of First Patient in Phase 1 Trial Cohort Evaluating XL092 in Combination with Atezolizumab in Patients with Advanced Solid Tumors. In October 2020, Exelixis announced enrollment of the first patient into the dose-escalation cohort of the combination arm of the phase 1 trial evaluating the safety, tolerability, PK and preliminary anti-tumor activity of XL092, both alone and in combination with atezolizumab, in patients with advanced solid tumors. Initiated in February 2019, the dose-escalation evaluation of the XL092 monotherapy arm of the phase 1 trial is ongoing. Once the recommended doses of both single-agent XL092 and XL092 in combination with atezolizumab are established, the trial will begin to enroll expansion cohorts for patients with clear cell and non-clear cell RCC, hormone-receptor positive breast cancer and metastatic castration-resistant prostate cancer (mCRPC). Exelixis In-Licenses Tissue Factor-Targeting Antibody-Drug Conjugate (ADC) Program from Collaborator Iconic Therapeutics, Inc. (Iconic). In December 2020, Exelixis and Iconic announced that Exelixis exercised its exclusive option to in-license Iconic’s lead oncology ADC program under the companies’ May 2019 collaboration agreement. As a result, Exelixis assumed responsibility for all subsequent clinical development, manufacturing and commercialization of the Tissue Factor-targeting ADC known as XB002 (formerly ICON-2). Exelixis plans to file an IND with the FDA for XB002 once drug product release assays are finalized and, pending the FDA’s acceptance of the IND, initiate a phase 1 clinical trial. Exelixis In-Licenses Novel CDK7 Inhibitor from Collaborator Aurigene, Files IND and Initiates Phase 1 Clinical Trial in Advanced Solid Tumors. In December 2020, Exelixis and Aurigene announced that Exelixis exercised its exclusive option to in-license XL102 under the companies’ July 2019 collaboration agreement. As a result, Exelixis assumed responsibility for all subsequent clinical development, manufacturing and commercialization of XL102. Following the FDA’s acceptance of Exelixis’ IND, in January 2021, Exelixis initiated a phase 1 clinical trial evaluating XL102, both as a single agent and in combination with other anti-cancer agents, for the treatment of patients with inoperable, locally advanced or metastatic solid tumors. Corporate Updates Inclusion in Fortune ’s 100 Fastest-Growing Companies List. In November 2020, Exelixis was named to Fortune ’s 100 Fastest-Growing Companies list, which ranks companies that are traded on a major U.S. stock exchange by their revenue growth rate, EPS growth rate and three-year annualized total return for the period ended June 30, 2020. In its first year on the list, Exelixis ranked 17 th overall and was the third-highest biopharmaceutical company. Exelixis Outlines Key Priorities and Anticipated Milestones for 2021. In January 2021, Exelixis announced its key priorities and anticipated milestones for 2021, including: the commercial launch of CABOMETYX in combination with OPDIVO as a first-line treatment of patients with advanced RCC; potential sNDA submissions for CABOMETYX in DTC, HCC and mCRPC; progress and enrollment in the COSMIC and CONTACT clinical studies evaluating cabozantinib as a single agent or in combination with ICIs; expanded clinical development activities for XL092; and multiple INDs for preclinical assets. Exelixis presented the details of its key priorities and anticipated milestones at the 39 th Annual J.P. Morgan Healthcare Conference. Exelixis and Adagene Inc. (Adagene) Enter into Collaboration and License Agreement to Develop Novel Masked ADC Therapies with Improved Safety and Efficacy Profiles. In February 2021, Exelixis and Adagene announced a collaboration and license agreement under which Exelixis will utilize Adagene’s SAFEbody™ technology platform to generate masked versions of monoclonal antibodies from Exelixis’ growing preclinical pipeline for the development of ADCs or other innovative biologics against Exelixis-nominated targets. Under the terms of the agreement, Exelixis will make an upfront payment of $11.0 million in exchange for an exclusive, worldwide license to develop and commercialize any potential ADC products generated by Adagene with respect to an initial target, as well as a second target Exelixis may nominate during the collaboration term. Adagene will be eligible for development, regulatory and commercialization milestones, as well as royalties on net sales of products developed around each of these targets. Basis of Presentation Exelixis has adopted a 52- or 53-week fiscal year that generally ends on the Friday closest to December 31 st. For convenience, references in this press release as of and for the fiscal periods ended January 1, 2021 and January 3, 2020 are indicated as being as of and for the periods ended December 31, 2020 and December 31, 2019, respectively. The periods ended December 31, 2020 were a 13-week fiscal quarter and a 52-week fiscal year, as compared to a 14-week fiscal quarter and a 53-week fiscal year for the comparable periods in 2019. Conference Call and Webcast Exelixis management will discuss the company’s financial results for the fourth quarter and full year 2020 and provide a general business update during a conference call beginning at 5:00 p.m. EST / 2:00 p.m. PST today, Wednesday, February 10, 2021. To access the webcast link, log onto www.exelixis.com and proceed to the News & Events / Event Calendar page under the Investors & Media heading. Please connect to the company’s website at least 15 minutes prior to the conference call to ensure adequate time for any software download that may be required to listen to the webcast. Alternatively, please call 855-793-2457 (domestic) or 631-485-4921 (international) and provide the conference call passcode 5481036 to join by phone. A telephone replay will be available until 8:00 p.m. EST on February 12, 2021. Access numbers for the telephone replay are: 855-859-2056 (domestic) and 404-537-3406 (international); the passcode is 5481036. A webcast replay will also be archived on www.exelixis.com for one year. About Exelixis Founded in 1994, Exelixis, Inc. (Nasdaq: EXEL) is a commercially successful, oncology-focused biotechnology company that strives to accelerate the discovery, development and commercialization of new medicines for difficult-to-treat cancers. Following early work in model system genetics, we established a broad drug discovery and development platform that has served as the foundation for our continued efforts to bring new cancer therapies to patients in need. Our discovery efforts have resulted in four commercially available products, CABOMETYX ® (cabozantinib), COMETRIQ ® (cabozantinib), COTELLIC ® (cobimetinib) and MINNEBRO ® (esaxerenone), and we have entered into partnerships with leading pharmaceutical companies to bring these important medicines to patients worldwide. Supported by revenues from our marketed products and collaborations, we are committed to prudently reinvesting in our business to maximize the potential of our pipeline. We are supplementing our existing therapeutic assets with targeted business development activities and internal drug discovery – all to deliver the next generation of Exelixis medicines and help patients recover stronger and live longer. Exelixis is a member of the Standard & Poor’s (S&P) MidCap 400 index, which measures the performance of profitable mid-sized companies. In November 2020, the company was named to Fortune ’s 100 Fastest-Growing Companies list for the first time, ranking 17 th overall and the third-highest biopharmaceutical company. For more information about Exelixis, please visit www.exelixis.com, follow @ExelixisInc on Twitter or like Exelixis, Inc. on Facebook. Forward-Looking Statements This press release contains forward-looking statements, including, without limitation, statements related to: Exelixis’ potential for top-line revenue growth in 2021 and beyond; Exelixis’ pursuit of additional regulatory approvals for cabozantinib and work towards a multi-billion dollar franchise; the potential for the combination of CABOMETYX and OPDIVO to be a best-in-class regimen in first-line RCC; Exelixis’ development plans for XL092; Exelixis’ regulatory and development plans for XB002; Exelixis’ 2021 financial guidance; Exelixis’ plans to file an sNDA for cabozantinib monotherapy in a DTC indication in 2021; Exelixis’ immediate and potential future financial obligations under the collaboration and license agreement with Adagene; planned cabozantinib presentations at ASCO GU 2021; Exelixis’ key priorities and anticipated milestones for 2021; and Exelixis’ plans to reinvest in its business to maximize the potential of the company’s pipeline, including through targeted business development activities and internal drug discovery. Any statements that refer to expectations, projections or other characterizations of future events or circumstances are forward-looking statements and are based upon Exelixis’ current plans, assumptions, beliefs, expectations, estimates and projections. Forward-looking statements involve risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in the forward-looking statements as a result of these risks and uncertainties, which include, without limitation: the continuing COVID-19 pandemic and its impact on Exelixis’ clinical trial, drug discovery and commercial activities; the degree of market acceptance of CABOMETYX and other Exelixis products in the indications for which they are approved and in the territories where they are approved, and Exelixis’ and its partners’ ability to obtain or maintain coverage and reimbursement for these products; the effectiveness of CABOMETYX and other Exelixis products in comparison to competing products; the level of costs associated with Exelixis’ commercialization, research and development, in-licensing or acquisition of product candidates, and other activities; Exelixis’ ability to maintain and scale adequate sales, marketing, market access and product distribution capabilities for its products or to enter into and maintain agreements with third parties to do so; the availability of data at the referenced times; the potential failure of cabozantinib and other Exelixis product candidates, both alone and in combination with other therapies, to demonstrate safety and/or efficacy in clinical testing; uncertainties inherent in the drug discovery and product development process; Exelixis’ dependence on its relationships with its collaboration partners, including their pursuit of regulatory approvals for partnered compounds in new indications, their adherence to their obligations under relevant collaboration agreements and the level of their investment in the resources necessary to complete clinical trials or successfully commercialize partnered compounds in the territories where they are approved; complexities and the unpredictability of the regulatory review and approval processes in the U.S. and elsewhere; Exelixis’ continuing compliance with applicable legal and regulatory requirements; unexpected concerns that may arise as a result of the occurrence of adverse safety events or additional data analyses of clinical trials evaluating cabozantinib and other Exelixis products; Exelixis’ dependence on third-party vendors for the development, manufacture and supply of its products and product candidates; Exelixis’ ability to protect its intellectual property rights; market competition, including the potential for competitors to obtain approval for generic versions of Exelixis’ marketed products; changes in economic and business conditions; and other factors discussed under the caption “Risk Factors” in Exelixis’ Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on November 5, 2020, and in Exelixis’ future filings with the SEC, including, without limitation, Exelixis’ Annual Report on Form 10-K expected to be filed with the SEC in February 2021. All forward-looking statements in this press release are based on information available to Exelixis as of the date of this press release, and Exelixis undertakes no obligation to update or revise any forward-looking statements contained herein, except as required by law. Exelixis, the Exelixis logo, CABOMETYX, COMETRIQ and COTELLIC are registered U.S. trademarks. MINNEBRO is a registered Japanese trademark. OPDIVO is a registered trademark of Bristol-Myers Squibb Company. -see attached financial tables- $ (4,347 Selling, general and administrative expenses (2) 315,009 $ CONDENSED CONSOLIDATED BALANCE SHEET DATA $ (unaudited) Weighted-average common shares outstanding: 19,374 304,338 $950 million – $1,050 million (1) $ Net product revenues Total assets 1,885,670 0.35 41,911 9,037 240,310 Pinterest 304,338 $ Basic Approximately 5% – 6% of net product revenue Facebook 1,879,113 0.26 Basic 1,538,842 967,775 Income before income taxes 680 $ $ RECONCILIATION OF GAAP NET INCOME TO NON-GAAP NET INCOME $ $ Selling, general and administrative 0.35 310,774 $ (in thousands, except per share amounts) 68,743 $ 94,448 302,584 321,012 (12,715 398,109 $ Non-GAAP net income (261 2019 $ December 31, 2019 Operating expenses: $ 0.27 (2) $1,150 million – $1,250 million 0.23 0.09 ) (23,542 Working capital Interest income Adjustments: 308,271 $ Twitter $ Collaboration services revenues Total revenues 194,926 (unaudited) Diluted EXELIXIS, INC. 1.02 336,964 (8 GAAP net income per share: $ $600 million – $650 million 245,755 Three Months Ended December 31, 167,295 7,706 1,685,970 $ 318,001 Net income per share: 77,316 Other income (expense), net ) 741,550 193,309 This cash and investments guidance does not include any potential new business development activity. 319,519 53,977 Total stockholders’ equity 1.21 315,030 $ 68,743 1.06 Diluted $ 0.14 28,388 Stock-based compensation – selling, general and administrative expenses (1) 319,519 ALAMEDA, Calif.–(BUSINESS WIRE)–Feb 10, 2021– Exelixis, Inc. (Nasdaq: EXEL) today reported financial results for the fourth quarter and full year 2020 and provided an update on progress toward achieving key corporate objectives, as well as commercial, clinical and pipeline development milestones. “I’m very proud of the Exelixis team’s execution in the fourth quarter and full year 2020 as we advanced all components of our business to enable top-line revenue growth in 2021 and beyond,” said Michael M. Morrissey, Ph.D., President and Chief Executive Officer of Exelixis. “Following the strong commercial performance of cabozantinib in the fourth quarter of 2020, Exelixis maintained momentum into 2021 with the FDA approval and launch of CABOMETYX in combination with OPDIVO as a first-line treatment for advanced renal cell carcinoma, based on the CheckMate -9ER study. Our commercial team is now hard at work bringing this important new combination therapy to every eligible patient that may benefit from this potentially best-in-class regimen.” Dr. Morrissey continued: “Looking ahead, we believe Exelixis is well positioned to deliver significant revenue growth as we pursue additional regulatory approvals for cabozantinib to benefit more patients and work towards a multi-billion-dollar franchise. In parallel, we’re focused on the rapid development of XL092, with plans to advance this next-generation oral tyrosine kinase inhibitor into pivotal trials this year. We also continue to make significant progress on our early-stage pipeline, having recently begun phase 1 development of XL102, our small molecule CDK7 inhibitor, and plan to file an Investigational New Drug application for XB002, our first antibody-drug conjugate, once the drug product release assays are finalized. With significant commercial opportunities and as our growing pipeline of small molecules and biologics matures, we are quickly working toward expanding our oncology product portfolio to further our mission to help cancer patients recover stronger and live longer.” Fourth Quarter and Full Year 2020 Financial Results Total revenues for the quarter and year ended December 31, 2020 were $270.1 million and $987.5 million, respectively, compared to $240.3 million and $967.8 million for the comparable periods in 2019. Total revenues for the quarter and year ended December 31, 2020 included net product revenues of $200.4 million and $741.6 million, respectively, compared to $194.9 million and $760.0 million for the comparable periods in 2019. The decrease in net product revenues for the full year 2020 was due to a decrease in sales volumes, which was partially offset by an increase in the average selling price. Collaboration revenues, composed of license revenues and collaboration services revenues, were $69.7 million and $246.0 million for the quarter and year ended December 31, 2020, respectively, compared to $45.4 million and $207.8 million for the comparable periods in 2019. The increases in collaboration revenues were primarily related to increases in milestone related revenues and development cost reimbursements earned, and higher royalty revenues for the sales of cabozantinib outside of the U.S. generated by Exelixis’ collaboration partners, Ipsen Pharma SAS (Ipsen) and Takeda Pharmaceutical Company Limited (Takeda). Research and development expenses for the quarter and year ended December 31, 2020 were $154.3 million and $547.9 million, respectively, compared to $94.4 million and $337.0 million for the comparable periods in 2019. The increases in research and development expenses were primarily related to increases in clinical trial costs, license and other collaboration costs, personnel expenses and stock-based compensation expense. Selling, general and administrative expenses for the quarter and year ended December 31, 2020 were $82.4 million and $293.4 million, respectively, compared to $58.0 million and $228.2 million for the comparable periods in 2019. The increases in selling, general and administrative expenses were primarily related to increases in stock-based compensation expense, corporate giving and personnel expenses. Provision for (benefit from) income taxes for the quarter and year ended December 31, 2020 was $(0.3) million and $19.1 million, respectively, compared to $16.3 million and $77.1 million for the comparable periods in 2019, primarily due to a decrease in pre-tax income. GAAP net income for the quarter ended December 31, 2020 was $28.4 million, or $0.09 per share, basic and diluted, compared to GAAP net income of $68.7 million, or $0.23 per share, basic and $0.22 per share, diluted, for the comparable period in 2019. GAAP net income for the year ended December 31, 2020 was $111.8 million, or $0.36 per share, basic and $0.35 per share, diluted, compared to GAAP net income of $321.0 million, or $1.06 per share, basic and $1.02 per share, diluted, for the year ended December 31, 2019. Non-GAAP net income for the quarter ended December 31, 2020 was $43.3 million, or $0.14 per share, basic and diluted, compared to non-GAAP net income of $81.0 million, or $0.27 per share, basic and $0.26 per share, diluted, for the comparable period in 2019. Non-GAAP net income for the year ended December 31, 2020 was $193.3 million, or $0.63 per share, basic and $0.61 per share, diluted, compared to non-GAAP net income of $364.9 million, or $1.21 per share, basic and $1.16 per share, diluted, for the year ended December 31, 2019. Non-GAAP net income excludes stock-based compensation, adjusted for the related income tax effect. Cash and investments were $1.5 billion at December 31, 2020, compared to $1.4 billion at December 31, 2019. Non-GAAP Financial Measures To supplement Exelixis’ financial results presented in accordance with U.S. Generally Accepted Accounting Principles (GAAP), Exelixis presents non-GAAP net income (and the related per share measures), which excludes from GAAP net income (and the related per share measures) stock-based compensation expense, adjusted for the related income tax effect for all periods presented. Exelixis believes that the presentation of these non-GAAP financial measures provides useful supplementary information to, and facilitates additional analysis by, investors. In particular, Exelixis believes that these non-GAAP financial measures, when considered together with its financial information prepared in accordance with GAAP, can enhance investors’ and analysts’ ability to meaningfully compare Exelixis’ results from period to period, and to identify operating trends in Exelixis’ business. Exelixis has excluded stock-based compensation expense, adjusted for the related income tax effect, because it is a non-cash item that may vary significantly from period to period as a result of changes not directly or immediately related to the operational performance for the periods presented. Exelixis also regularly uses these non-GAAP financial measures internally to understand, manage and evaluate its business and to make operating decisions. These non-GAAP financial measures are in addition to, not a substitute for, or superior to, measures of financial performance prepared in accordance with GAAP. Exelixis encourages investors to carefully consider its results under GAAP, as well as its supplemental non-GAAP financial information and the reconciliation between these presentations, to more fully understand Exelixis’ business. Reconciliations between GAAP and non-GAAP results are presented in the tables of this release. 2021 Financial Guidance Exelixis is providing the following financial guidance for fiscal year 2021: (3,567 Includes $45 million of non-cash stock-based compensation expense. Cost of goods sold 1.06 16,271 1,240,737 CONDENSED CONSOLIDATED STATEMENTS OF INCOME 318,001 43,320 315,030 $ TAGS  877,478 $ 0.22 308,271 Total operating expenses Research and development 0.23 19,865 $ 11,913 Previous articleSolid company earnings and hopes for aid send stocks higherNext articleOAT020321_OC_Mens_JF_07 Digital AIM Web Supportlast_img read more

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first_imgNews UpdatesKarnataka High Court Seeks Report On FIR Against Alleged Corruption In BBMP’s Bed Allocation Mustafa Plumber5 May 2021 8:56 PMShare This – xImage Courtesy: T. Narayan/BloombergThe Karnataka High Court on Wednesday orally directed the State government to by next week submit a report of the Investigating officer probing the case regarding alleged corruption and malpractice in allocating beds through the BBMP’s centralised bed allocation system for COVID patients. A division bench of Chief Justice Abhay Oka and Justice Aravind Kumar orally directed the State government to produce in a sealed envelope the investigation report. It said “There is some FIR registered in regards to allocation of beds in Bengaluru. We would like to have the report of the investigating officer.” Advocate General Prabhuling K Navadgi said the FIR is being investigated by the CCB and the report would be submitted to the court. The police started the investigation following an allegation by BJP Bengaluru South MP Tejasvi Surya. The police have till now arrested four persons in the case. Surya had claimed that bribes are being taken to allocate Covid beds. He also stated that a nexus of BBMP officers, Arogya Mitras and certain private agents is behind this scam. This had led to an artificial shortage of beds in the city. The direction was issued after Advocate G R Mohan brought to the notice of the court about the FIR being registered and investigated by the police.TagsKarnataka High Court BBMP Karnataka Government Next Storylast_img read more

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first_imgHamilton County Sheriff(CINCINNATI) — A convicted felon who impersonated an Ohio boy that vanished in 2011 at age 6 is scheduled to appear in court Tuesday afternoon on charges of lying to federal agents, a cruel hoax that briefly lifted the hopes of the missing child’s loved ones.Brian Michael Rini, 23, is expected to appear in U.S. District Court in Cincinnati.Rini led authorities in three states on a wild goose chase on April 3 when he was found wandering around the streets of Newport, Ky., and then telling police he was Timmothy Pitzen — the Aurora, Ill., boy who disappeared when he was 6 years old in 2011 and would be 14 years old now. Rini allegedly told police he had escaped from two kidnappers, both white males with “body-builder-type builds, who had been holding him at a motel in the Cincinnati suburb of Sharonville.Detectives from the Cincinnati Police Department and agents from the Federal Bureau of Investigation (FBI) in Chicago probed the claims made by Rini, who refused to submit his fingerprints but gave investigators a DNA sample that showed he was an imposter, according to a criminal complaint.“It’s devastating,” Timmothy’s aunt, Kara Jacobs, told reporters after authorities revealed the imposter’s true identity. “It’s like reliving the day all over again,” she said. “Timmothy’s father is devastated once again.”Timmothy was last seen in 2011 being checked out of his Aurora school by his mother, Amy Fry-Pitzen, police said. The search for him and his mother spanned the region before his mother was found dead by suicide in a motel room in Rockford, Ill.Fry-Pitzen left a note saying Timmothy was safe with people who were caring for him, but would never be found, police said.After he was confronted with the DNA test results that confirmed he was not Timmothy, Rini confessed to his alleged lie and said he learned about the boy from a report on the case that aired on ABC’s “20/20,” according to the criminal complaint.“He stated that he wanted to get away from his own family,” Cincinnati Police Detective Mary Braun, who is also a member of an FBI Task Force on missing and abused children, wrote in the criminal complaint. “When questioned further, Rini stated that he wished he had a father like Timmothy’s…”According to the criminal complaint, Rini, who has a long criminal record, was released from an Ohio prison on March 7. Ohio Department of Rehabilitation and Correction officials said Rini served an 18-month sentence for burglary and vandalism.On two previous occasions, Rini falsely “portrayed himself as a juvenile sex trafficking victim,” according to the complaint.Copyright © 2019, ABC Radio. All rights reserved.last_img read more

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first_imgPembroke College has passed a motion to add the role of meme rep to the JCR committee.The meme rep will create and run a Facebook page called ‘Memebroke’, posting weekly memes and providing memes for bops and other college events. The motion, proposed by Freshers Rebeccah Williams and Hazel Ellender, noted: “College spirit and memes are both highly important, and particularly difficult to promote.“The addition of recognised meme reps will encourage both of these simultaneously. Meme reps will be a valuable and cherished extension to the Pembroke community.” Williams told Cherwell, “Hazel and I decided to introduce the position of meme reps as we thought it would help boost morale around college especially around fifth and sixth week.“We think it’s important for the college to stay current and that it would help Pembroke preserve its friendly and fun atmosphere. We intend to use the memes to help promote Pembroke events such as bops and also sporting events in which Pembroke are competing such as Torpids.”An amendment to the motion requires second-year student Francesco Pozzetti to post one of his memes weekly on the JCR Facebook page following the failure of his motion “To officially consider Juventus an immoral and an illegal organisation, and to therefore discourage any member of this college from supporting them”.Pozzetti told Cherwell: “After an intense thirty minutes debate my motion regarding Juventus mafia in Italian football narrowly failed. My attention turned to the meme motion, and I managed to include an amendment that allows me to inform people about the Juventus mafia by posting a meme once a week on our JCR official Facebook page. Luckily, students still believe in memes as a way to get relief at 2am in the middle of an essay crisis, and so the meme motion passed: Pembroke is proud to be the first college to include a meme rep in its committee.”last_img read more

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first_imgConstantine lighting up a bowl on a road trip. The Flanders Hotel is a proud host of High Tea, as summer comes to a close there are just four more summer Teas by the Sea. But worry not, tea is served year round.High Tea ScheduleTea served 2pmEvery Thursday and Sunday in June, July, and AugustAugust Teas; 18th, 21st, 25th, and 28th.Fall teas will be the first Thursday and third Sunday of each month.September*: 1st, 8th, and 18thOctober: 6th and 16thNovember: 3rd and 20thMenu includes;Your choice of freshly brewed tea, savories, sandwiches and sweetsFor reservations please call (609) 399 1000Free ParkingReservations Required – $29.95 per person plus tax and gratuity.last_img

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first_imgLoad remaining images Gov’t Mule is currently in the midst of their Revolution Come…Revolution Go tour, with their most recent stop at Red Rocks Amphitheatre in Morrison, Colorado. The show was packed with highlights, as Yonder Mountain String Band and Marcus King Band all shared the bill for a miraculous evening of music. Warren Haynes made sure to bring up the musicians at hand for the Mule performance, which included a vast array of originals and covers.Gov’t Mule opened their show with newly released “Traveling Tune,” before bringing it back to their 1998 Dose track “Game Face,” with included a tease of The Weather Report‘s “Birdland.” Returning to Dose for “Thorazine Shuffle,” Haynes and company rocked through to “Time To Confess” and “The Man I Want To Be,” only once before played in Pittsburgh, before leaning into the 2017 single “Revolution Come, Revolution Go.”The first Allman Brothers Band tribute came next, with “Come And Go Blues” from their 1973 Brothers And Sisters album. From there, the band locked into a cover of The J.B.‘s “Doing It To Death,” before returning to original tune “Scenes From A Troubled Mind,” which featured teases of the Allman Brothers’ “Les Brers In A Minor” and “Silent Scream.” The teases continued in “Unring The Bell” with shades of the Grateful Dead‘s “Shakedown Street.” High & Mighty‘s “Endless Parade” followed, before “Stone Cold Rage” and “Traveling Tune” returned the band home to their 2017 grievances. The set closed with a massive cover of “Whipping Post” by the Allman Brothers Band, with young guitarist and vocalist Marcus King as the first guest of the evening.The band returned for a legendary encore with Marcus King, and Yonder Mountain String Band’s Dave Johnston, Adam Aijala, Allie Kral, and Jake Joliff. What came next is a collaboration that will be talked about for ages, as the musicians played through a touching version of the Allman Brothers Band’s “Melissa,” marking Mule’s first time playing the song live, leading into ABB’s enormous “Mountain Jam” and back into “Melissa.” In perhaps Mule’s biggest tribute yet, the Allman Brothers Band were hugely celebrated at Red Rocks on Saturday night.Watch Marcus King join Gov’t Mule for “Whipping Post”:Watch Marcus King, Dave Johnston, Adam Aijala, Allie Kral, and Jake Joliff join Gov’t Mule for “Melissa”>”Mountain Jam”>”Melissa” below:Thanks to Bennet Schwartz, you can listen to the full audio below:Setlist: Gov’t Mule | Red Rocks Amphitheatre | Morrison, CO | 8/19/17Traveling Tune > Game Face (with Birdland tease), Thorazine Shuffle, Time To Confess, The Man I Want To Be, Revolution Come, Revolution Go, Come & Go Blues, Doing It To Death, Scenes From A Troubled Mind (with Les Brers In A Minor & Silent Scream teases), Unring The Bell (with Shakedown Street tease), Endless Parade, Stone Cold Rage, Traveling Tune, Whipping Post^E: Melissa* > (Live Debut) Mountain Jam* > Melissa*^ w/ Marcus King* w/ Marcus King, Dave Johnston, Adam Aijala, Allie Kral & Jake Joliff)[Setlist from Gov’t Mule Facebook]See the full gallery below, courtesy of Gary Sheer.Gov’t Mule | Red Rocks Amphitheatre | Morrison, CO | 8/19/17 | Photos by Gary Sheerlast_img read more

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first_imgThis summer, American folk-rock hero Bob Dylan will release Rolling Thunder Revue: The 1975 Live Recordings. The mammoth box set will include a mind-blowing 148 tracks from five full Dylan sets that were professionally recorded throughout the 1975 caravan/tour. The ambitious box set will also include three discs of rehearsals and one disc of rare performances.On Tuesday, Dylan shared a recording of him and his band rehearsing “One More Cup of Coffee (Valley Below)”, which took place prior to the tour at the Seacrest Motel in Falmouth, MA.Related: Bob Dylan To Open ‘Heaven’s Door’ Whiskey Distillery & Center For The Arts In Nashville In 2020The rehearsal of the song, which would go on to appear on Dylan’s 1976 Desire LP, hears Dylan opening the performance with the strumming of his acoustic guitar before powerfully belting out the song’s opening lyrics. Dylan and his guitar are accompanied in the raw recording by limited instrumentation including the violin, a simple drum beat, and backing vocalists during the song’s folk-like chorus. In all, the recording sounds more like a collaboration between passing gypsies in the street than that of the generation’s most acclaimed songwriters–which perfectly matches the spirit of Rolling Thunder‘s touring caravan of musicians. Fans can hear the new recording in the video below.Bob Dylan – “One More Cup of Coffee (Valley Below)”[Video: Bob Dylan]Fans will also get the chance to dive into the wild world of Dylans’ 1975 tour when the Martin Scorsese-directed documentary, Rolling Thunder Revue: A Bob Dylan Story, arrives on Netflix just a few days after the arrival of the box set on June 11th. The Rolling Thunder Revue: The 1975 Live Recordings is scheduled to arrive on June 7th. Fans can click here to pre-order the album box set.last_img read more

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first_img Read Full Story A recent study showing that people covered by Medicaid may be less depressed than those who aren’t has prompted new debate about the value of such insurance, according to an article in the June 23 “Ideas” section of the Boston Globe. The article detailed the results of a May 2013 New England Journal of Medicine study co-authored by Katherine Baicker, professor of health economics at Harvard School of Public Health (HSPH), and MIT economist Amy Finkelstein, that found that people in Oregon with access to Medicaid were 30 percent less likely than their counterparts to screen positive for depressionSince the study did not find any significant health improvements among those on Medicaid, some have reacted by criticizing Medicaid expansion and “Obamacare.” Others think it’s important to consider health insurance’s association with lowered depression — likely the result of less worry about finances — because depression has been linked with increased risk of stroke, heart disease, and diabetes.last_img read more

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first_imgRoses are typically viewed as one of the most beautiful flowers, but in rare cases a tiny pest can cause gnarly looking, new growth on rose bushes. Rose leaf-curl mites feed on roses and cause rose rosette virus, also known as RRV. The extremely small eriophyid mite feeds on plant sap from the tender stems and leaf petioles. The pest alone causes little damage while feeding, but if it is a carrier of RRV, symptoms begin to appear in the rose typically within one to three months. There is no cure for RRV and it is not always preventable, since there are no vaccines for plant viruses.Causes thick, succulent stemsInfected roses exhibit reddened terminal growth on infected branches, and the stems become thicker and more succulent than those on unaffected parts of the plant. These stems exhibit an abnormally high number of pliable thorns, which may be either green or red. Infected rose bushes produce less flowers and the petals may be distorted and fewer in number. Rose leaves that develop on infected branches are smaller than normal and may be deformed similarly to herbicide injury by 2,4-D. Lateral branches may grow excessively from main stems and create a witch’s broom symptom, much like injury from herbicide glyphosate (Roundup and other brands). Treat nearby rose bushesTo reduce the spread of leaf-curl mites from the site of an infected rose, nearby roses can be treated with an insecticide spray containing bifenthrin or a horticultural summer oil every two weeks between April and September. This may help prevent additional plants from becoming virus infected by any sap-vectoring mites. Symptoms of the virus generally become evident in the late spring to early summer and progress during the growing season. By late summer or fall, the plant will have a noticeable amount of abnormal, gnarly growth. Once the rose becomes infected, RRV moves throughout the plant and the entire bush becomes infected. By the time symptoms are evident in a rose, the virus may have spread to adjacent roses by the movement of the mites. Only affects rosesInfected plants typically die within a couple of years. The good news is RRV only affects roses, so other plants in your garden won’t get this disease unless they are closely related to the rose plant. Since there are no treatments for plant viruses, infected roses should be immediately removed, then burned or bagged for disposal. Also remove any roots that might re-sprout later. Do not leave an uprooted, infected plant in the garden, as the mites may leave this bush for other nearby roses. When planting new roses, space plants far enough apart so that they do not touch in order to minimize potential spread of these types of diseases. Because RRV is systemic within the infected rose plants, grafting infected stems onto other rose plants will transmit the virus. Nursery growers may infect roses this way through poor propagation practices. Pruning shears and other tools used on diseased roses should be disinfected with rubbing alcohol or a 10 percent diluted bleach solution before being used on healthy plants. Sap left on the pruners can contaminate other roses. For more information on growing roses, refer to the University of Georgia Cooperative Extension publications at www.caes.uga.edu/publications/.last_img read more

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