Exelixis Announces Fourth Quarter and Full Year 2019 Financial Results and Provides Corporate Update

Exelixis 公布二零一九年第四季度及全年财务业绩并提供企业更新

2020-02-26 05:05:00 Business Wire

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- Non-GAAP Diluted EPS of $0.26 for the Fourth Quarter of 2019, $1.16 for the Full Year 2019 - - Conference Call and Webcast Today at 5:00 PM Eastern Time - Exelixis, Inc. (Nasdaq: EXEL) today reported financial results for the fourth quarter and full year 2019 and provided an update on progress toward fulfilling its key corporate objectives, as well as commercial and clinical development milestones. "Exelixis achieved strong financial performance in 2019, with significant growth in total revenue and expansion of the cabozantinib franchise, which for the first time exceeded $1.0 billion in annual global net revenue," said Michael M. Morrissey, Ph.D., President and Chief Executive Officer of Exelixis. "We concluded the company’s 25th anniversary year with a strong balance sheet and profitable business, which enables Exelixis to continue our ongoing investment to expand the cabozantinib franchise into new indications and build a pipeline of differentiated oncology assets through targeted business development and internal drug discovery activities." Dr. Morrissey continued: "Our execution across the commercial, clinical and discovery components of our business in 2019 helped set a strong foundation for Exelixis in 2020, with an impactful lineup of clinical and regulatory milestones expected over the course of the next two years. We ended 2019 with nine ongoing potentially label-enabling trials for cabozantinib, with three additional pivotal trials expected to initiate this year. We’re anticipating data readouts from six of these ongoing trials in 2020, with the potential for as many as four new approved indications for the cabozantinib franchise by the end of 2021, while rebuilding our oncology pipeline with up to three new investigational new drug filings this year. The entire Exelixis team has worked with focus and determination to advance the business to this point, and we’re moving decisively to execute on our corporate priorities and bring new medicines forward for the cancer patients that need them." Fourth Quarter and Full Year 2019 Financial Results (see Basis of Presentation below for further detail) Total revenues for the quarter and year ended December 31, 2019 were $240.3 million and $967.8 million, respectively, compared to $228.6 million and $853.8 million for the comparable periods in 2018. Total revenues for the quarter and year ended December 31, 2019 included net product revenues of $194.9 million and $760.0 million, respectively, compared to $176.2 million and $619.3 million for the comparable periods in 2018. The increases in net product revenues reflected the continued growth of CABOMETYX® (cabozantinib) in the U.S. for the treatment of patients with advanced renal cell carcinoma (RCC), as well as the U.S. launch of CABOMETYX for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib, following its approval by the U.S. Food and Drug Administration (FDA) in January 2019. Total revenues for the quarter and year ended December 31, 2019 included collaboration revenues of $45.4 million and $207.8 million, respectively, compared to $52.4 million and $234.5 million for the comparable periods in 2018. The decreases in collaboration revenues were primarily related to decreases in the recognition of milestone related revenues. These decreases in collaboration revenues were partially offset by higher royalty revenues that were primarily attributed to cabozantinib-related revenues from Exelixis’ partner Ipsen outside of the U.S. Research and development expenses for the quarter and year ended December 31, 2019 were $94.4 million and $337.0 million, respectively, compared to $57.3 million and $182.3 million for the comparable periods in 2018. The increases in research and development expenses were primarily related to increases in clinical trial costs, license and other collaboration costs and personnel expenses. The increases in clinical trial costs were primarily due to costs associated with the expanding clinical trial program for cabozantinib, which includes CheckMate 9ER, COSMIC-311, COSMIC-312, COSMIC-313 and COSMIC-021. The increases in license and other collaboration costs were primarily a result of increases in discovery activities with collaboration partners related to in-licensed technology. The increases in personnel expenses were primarily due to increases in headcount to support Exelixis’ expanded discovery and development efforts. Selling, general and administrative expenses for the quarter and year ended December 31, 2019 were $58.0 million and $228.2 million, respectively, compared to $52.4 million and $206.4 million for the comparable periods in 2018. The increases in selling, general and administrative expenses were primarily related to increases in personnel expenses and stock-based compensation, partially offset by a decrease in corporate giving. The increases in personnel expenses were primarily due to increases in administrative headcount to support Exelixis’ commercial and research and development organizations. The increases in stock-based compensation were primarily due to increases in headcount, as well as the expense recognition for certain of the restricted stock units that were granted in 2018 that either have vested or are expected to vest upon the achievement of specific performance targets. Income tax provision for the quarter and year ended December 31, 2019 was $16.3 million and $77.1 million, respectively, compared to an income tax benefit of $243.7 million and $238.0 million for the comparable periods in 2018. The provision for income taxes relating to Exelixis’ pre-tax income for the quarter and year ended December 31, 2018 was more than offset by a valuation allowance against its net operating loss carryforwards and other deferred tax assets. At December 31, 2018, Exelixis released substantially all of the remaining valuation allowance against Exelixis’ deferred tax assets after Exelixis determined that it was more likely than not that these deferred tax assets would be realized. GAAP net income for the quarter ended December 31, 2019 was $68.7 million, or $0.23 per share, basic and $0.22 per share, diluted, compared to GAAP net income of $360.1 million, or $1.20 per share, basic and $1.15 per share, diluted, for the comparable period in 2018. GAAP net income for the year ended December 31, 2019 was $321.0 million, or $1.06 per share, basic and $1.02 per share, diluted, compared to GAAP net income of $690.1 million, or $2.32 per share, basic and $2.21 per share, diluted, for the comparable period in 2018. The decreases in net income were primarily related to the 2018 release of substantially all of the remaining valuation allowance against Exelixis’ deferred tax assets, increases in research and development expenses and decreases in milestone revenues; those changes were partially offset by increases in net product revenues. Non-GAAP net income for the quarter ended December 31, 2019 was $81.0 million, or $0.27 per share, basic and $0.26 per share, diluted, compared to non-GAAP net income of $128.1 million, or $0.43 per share, basic and $0.41 per share, diluted, for the comparable period in 2018. Non-GAAP net income for the year ended December 31, 2019 was $364.9 million, or $1.21 per share, basic and $1.16 per share, diluted, compared to non-GAAP net income of $485.8 million, or $1.63 per share, basic and $1.55 per share, diluted, for the comparable period in 2018. Non-GAAP net income excludes the non-cash income tax benefit related to the release of substantially all of the valuation allowance against the company’s deferred tax assets as of December 31, 2018 described above and stock-based compensation, adjusted for the related income tax effect. Cash and investments totaled $1.4 billion at December 31, 2019, compared to $0.9 billion at December 31, 2018. 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 exclude from GAAP net income (and the related per share measures) the non-cash income tax benefit related to the release of substantially all of the valuation allowance against the company’s deferred tax assets in 2018 and 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 these items because they are non-cash items 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. 2020 Financial Guidance Exelixis is providing the following financial guidance for fiscal year 2020: Total revenues $850 million - $900 million Net product revenues $725 million - $775 million Cost of goods sold 4% - 5% of net product revenues Research and development expenses(1) $460 million - $500 million Selling, general and administrative expenses(2) $230 million - $250 million Effective tax rate 20% - 22% Cash and investments(3) $1.5 billion - $1.6 billion (1) Includes $25 million of non-cash stock-based compensation expense. (2) Includes $30 million of non-cash stock-based compensation expense. (3) This cash guidance does not include any potential new business development activity, which remains a key priority for Exelixis as it continues to build toward becoming a multi-product oncology company. Cabozantinib Highlights Cabozantinib Full Year 2019 Franchise Net Revenues Exceed $1.0 Billion Globally. Net product revenues generated by the cabozantinib franchise in the U.S. were $194.9 million during the fourth quarter of 2019, an increase of 10.6% year-over-year, with net product revenues of $181.1 million for CABOMETYX and $13.8 million for COMETRIQ® (cabozantinib). Exelixis earned $17.0 million in royalty revenues based upon Ipsen’s cabozantinib-related revenues in the fourth quarter of 2019. Cabozantinib continues to expand its global footprint, where it is currently approved and commercially available in 52 and 49 countries, respectively. In 2019, global cabozantinib franchise net revenue generated by Exelixis and its partner Ipsen exceeded $1.0 billion for the first time in a calendar year. Health Canada Approves CABOMETYX for First-Line Treatment of Adults with Advanced RCC. In October 2019, Ipsen announced Health Canada’s approval of CABOMETYX for the first-line treatment of adults with advanced RCC. Under the collaboration agreement with Ipsen, Exelixis received a $3.0 million milestone payment for the Health Canada approval, which was recognized as revenue in the fourth quarter of 2019. CABOMETYX was originally approved in Canada in September 2018 for the treatment of adults with advanced RCC who have received prior vascular endothelial growth factor targeted therapy. Health Canada Approves CABOMETYX for the Treatment of Patients with Previously Treated Advanced HCC. In November 2019, Ipsen announced Health Canada’s approval of CABOMETYX for the treatment of patients with HCC who have been previously treated with sorafenib. Under the collaboration agreement with Ipsen, Exelixis received a $2.0 million milestone payment for the Health Canada approval, which was recognized as revenue in the fourth quarter of 2019. Announcement of Clinical Collaboration with F. Hoffmann-La Roche Ltd. (Roche) for Three Phase 3 Combination Trials for Patients with Advanced Solid Tumors. In December 2019, Exelixis announced a collaboration agreement with Roche to evaluate cabozantinib in combination with atezolizumab, Roche’s PD-L1 immune checkpoint inhibitor, in patients with locally advanced or metastatic solid tumors. The clinical program, which will be co-funded by the companies, is expected to include three phase 3 pivotal trials in advanced non-small cell lung cancer, metastatic castration-resistant prostate cancer (mCRPC) and RCC. Further Expansion of Prostate Cancer Cohort in Phase 1b COSMIC-021 Trial of Cabozantinib in Combination with Atezolizumab in Patients with Advanced Solid Tumors. In January 2020, Exelixis announced that based on continued encouraging efficacy and safety data, the company plans to further expand the mCRPC cohort of COSMIC-021, the phase 1b trial of cabozantinib in combination with atezolizumab in patients with locally advanced or metastatic solid tumors. The cohort, which was previously expanded from 30 to 80 patients in July 2019, will now include up to 130 patients. Presentation of Clinical Results from CheckMate 040 Clinical Trial of the Combination of Cabozantinib and Nivolumab with or without Ipilimumab in Advanced HCC. In January 2020, Exelixis announced phase 1/2 clinical trial results from the combination of cabozantinib and nivolumab with or without ipilimumab in advanced HCC. Data from the cabozantinib combination cohort of the CheckMate 040 trial were presented on Friday, January 24th at American Society of Clinical Oncology’s (ASCO) Gastrointestinal Cancers Symposium, which was held in San Francisco, California. These data support Exelixis’ clinical development program of cabozantinib plus immune checkpoint inhibitors in advanced HCC, including the ongoing COSMIC-312 phase 3 pivotal trial of cabozantinib plus atezolizumab versus sorafenib in previously untreated patients. Readout of Phase 1b COSMIC-021 Trial mCRPC Cohort at ASCO’s Genitourinary Cancers Symposium. In February 2020, Exelixis announced positive efficacy and safety results from an interim analysis of the mCRPC cohort of COSMIC-021. The data were presented on Thursday, February 13th at ASCO's Genitourinary Cancers Symposium, which was held in San Francisco, California. Based on regulatory feedback from the FDA and if supported by the clinical data from the ongoing mCRPC expansion cohorts from COSMIC-021, Exelixis intends to file with the FDA for accelerated approval in an mCRPC indication as early as 2021. Corporate Updates Exelixis and Invenra, Inc. (Invenra) Expand Collaboration Focused on the Discovery and Development of Multispecific Antibodies for the Treatment of Cancer. In October 2019, Exelixis expanded its collaboration with Invenra to include the development of novel binders against six additional targets. Under the terms of the expanded collaboration agreement, Exelixis will have the opportunity to use these binders to generate multispecific antibodies based on Invenra’s B-Body™ technology platform, or with other platforms and formats, at Exelixis’ option. Exelixis Files Lawsuit to Enforce Its Intellectual Property Rights for CABOMETYX against Abbreviated New Drug Application (ANDA) Filer. In October 2019, Exelixis filed a patent infringement lawsuit against MSN Pharmaceuticals, Inc. (MSN), following receipt of a Paragraph IV certification notice letter from MSN that it had filed an ANDA with the FDA requesting approval to market a generic version of CABOMETYX tablets, following expiration of the CABOMETYX composition of matter patent, U.S. Patent No. 7,579,473, which expires on August 14, 2026. Exelixis is seeking, among other relief, an order that the effective date of any FDA approval of the ANDA would be a date no earlier than the expiration of U.S. Patent No. 8,877,776 on October 8, 2030 and equitable relief enjoining MSN from infringing this patent. Exelixis’ Collaborator Daiichi Sankyo Company, Limited (Daiichi Sankyo) Announces Positive Results from Phase 3 Pivotal Trial of Esaxerenone in Patients with Diabetic Nephropathy. In November 2019, Exelixis announced that its partner Daiichi Sankyo reported positive results from a phase 3 pivotal trial of esaxerenone in patients with diabetic nephropathy. Esaxerenone is a novel mineralocorticoid receptor blocker identified during the prior research collaboration between Exelixis and Daiichi Sankyo and subsequently developed and commercialized by Daiichi Sankyo. Esaxerenone has been approved as a treatment for patients with hypertension in Japan, where it is marketed as MINNEBRO® tablets. Daiichi Sankyo is solely responsible for esaxerenone’s development and commercialization, with Exelixis remaining eligible for substantial commercialization milestones, as well as low double-digit royalties on sales, as it advances. Announcement of Positive Results from IMspire150. In December 2019, Exelixis announced positive results from IMspire150, the phase 3 trial of atezolizumab, cobimetinib and vemurafenib in people with previously untreated BRAF V600 mutation-positive advanced melanoma. Genentech, Inc. (a member of the Roche Group), Exelixis’ collaborator and the sponsor of the IMspire150 trial, informed Exelixis that the study met its primary endpoint of progression-free survival. Results will be presented at an upcoming medical meeting and discussed with health authorities around the world, including the FDA and the European Medicines Agency. Exelixis Outlines Key Priorities and Anticipated Milestones for 2020-21. In January 2020, Exelixis announced its key priorities and anticipated milestones for 2020-21, including generating top-line data from as many as six ongoing trials with label-enabling potential, initiating at least three new pivotal trials, and progressing its mid-stage and early pipeline, with up to three new investigational new drug filings in 2020. The company intends to make appropriate investments to maximize the clinical development opportunities for CABOMETYX, which Exelixis believes could lead to as many as four additional approved indications by year-end 2021, while concurrently working to advance a pipeline of potential new Exelixis medicines through internal drug discovery and business development. Basis of Presentation Exelixis has adopted a 52- or 53-week fiscal year that generally ends on the Friday closest to December 31st. For convenience, references in this press release as of and for the fiscal periods ended January 3, 2020 and December 28, 2018 are indicated as being as of and for the periods ended December 31, 2019 and December 31, 2018, respectively. The periods ended December 31, 2019 were a 14-week fiscal quarter and a 53-week fiscal year, as compared to a 13-week fiscal quarter and a 52-week fiscal year for the comparable the periods in 2018. Conference Call and Webcast Exelixis management will discuss the company’s financial results for the fourth quarter and full year 2019 and provide a general business update during a conference call beginning at 5:00 p.m. ET / 2:00 p.m. PT today, Tuesday, February 25, 2020. 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 9168158 to join by phone. A telephone replay will be available until 8:00 p.m. ET on February 27, 2020. Access numbers for the telephone replay are: 855-859-2056 (domestic) and 404-537-3406 (international); the passcode is 9168158. 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 approved 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 Standard & Poor’s (S&P) MidCap 400 index, which measures the performance of profitable mid-sized companies. 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’ expectation to achieve an impactful lineup of clinical and regulatory milestones over the next two years, including data readouts from six of its nine ongoing potentially label-enabling trials for cabozantinib in 2020, with the potential for as many as four new approved indications for the cabozantinib franchise by the end of 2021, the initiation of three additional pivotal trials in non-small cell lung cancer, mCRPC and RCC in 2020 and a rebuilding of Exelixis’ oncology pipeline with up to three new investigational new drug filings in 2020; Exelixis’ updated 2020 financial guidance; Exelixis’ plans to further expand the mCRPC cohort of COSMIC-021 to include up to 130 patients; Exelixis’ intention to file with the FDA for accelerated approval of the combination of cabozantinib and atezolizumab in a mCRPC indication as early as 2021, if supported by the clinical data; Exelixis’ obligations under its collaboration agreement with Invenra; Exelixis’ eligibility for substantial commercialization milestones, as well as low double-digit royalties on sales of MINNEBRO; Genentech’s plans to present the IMspire150 data at an upcoming medical meeting and discuss the data with health authorities around the world; 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 degree of market acceptance of CABOMETYX, COMETRIQ, COTELLIC and MINNEBRO in the territories where they are approved, and Exelixis’ ability to obtain or maintain coverage and reimbursement for these products; the effectiveness of CABOMETYX, COMETRIQ, COTELLIC and MINNEBRO 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; 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, including evolving regulatory requirements, slower than anticipated patient enrollment, inability to identify a sufficient number of clinical trial sites or limited availability of third-party scientific advisors and contractors; 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; the regulatory review and approval processes, including the risk that regulatory authorities may not approve Exelixis’ products as treatments for the indications in which approval has been sought; 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, cobimetinib or esaxerenone; Exelixis’ dependence on third-party vendors for the manufacture and supply of its products; 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 October 30, 2019, 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 on February 25, 2020. 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. Exelixis, the Exelixis logo, CABOMETYX, COMETRIQ and COTELLIC are registered U.S. trademarks. MINNEBRO is a registered Japanese trademark. EXELIXIS, INC. CONDENSED CONSOLIDATED STATEMENTS OF INCOME (in thousands, except per share amounts) (unaudited) Three Months Ended December 31, Year Ended December 31, 2019 2018 2019 2018 Revenues: Net product revenues $ 194,926 $ 176,225 $ 759,950 $ 619,279 Collaboration revenues 45,384 52,377 207,825 234,547 Total revenues 240,310 228,602 967,775 853,826 Operating expenses: Cost of goods sold 10,520 7,352 33,097 26,348 Research and development 94,448 57,271 336,964 182,257 Selling, general and administrative 58,026 52,377 228,244 206,366 Total operating expenses 162,994 117,000 598,305 414,971 Income from operations 77,316 111,602 369,470 438,855 Other income (expense), net: Interest income 7,706 4,741 27,959 12,840 Other, net (8 ) 29 680 397 Total other income (expense), net 7,698 4,770 28,639 13,237 Income before income taxes 85,014 116,372 398,109 452,092 Income tax provision (benefit) 16,271 (243,717 ) 77,097 (237,978 ) Net income $ 68,743 $ 360,089 $ 321,012 $ 690,070 Net income per share, basic $ 0.23 $ 1.20 $ 1.06 $ 2.32 Net income per share, diluted $ 0.22 $ 1.15 $ 1.02 $ 2.21 Shares used in computing net income per share, basic 304,338 299,409 302,584 297,892 Shares used in computing net income per share, diluted 315,030 312,443 315,009 312,803 EXELIXIS, INC. CONDENSED CONSOLIDATED BALANCE SHEET DATA (in thousands) (unaudited) December 31, December 31, 2019 2018 Cash and investments $ 1,388,628 $ 851,621 Working capital $ 868,444 $ 791,544 Total assets $ 1,885,670 $ 1,422,286 Total stockholders’ equity $ 1,685,970 $ 1,287,453 EXELIXIS, INC. RECONCILIATION OF GAAP NET INCOME TO NON-GAAP NET INCOME (in thousands, except per share amounts) (unaudited) Three Months Ended December 31, Year Ended December 31, 2019 2018 2019 2018 GAAP net income $ 68,743 $ 360,089 $ 321,012 $ 690,070 Adjustments: Stock-based compensation - research and development expenses (1) 5,629 4,013 19,374 13,115 Stock-based compensation - selling, general and administrative expenses (1) 10,226 8,283 37,228 27,511 Income tax effect of the above adjustments (3,567 ) (220 ) (12,715 ) (787 ) Income tax benefit resulting from the release of the valuation allowance (2) — (244,111 ) — (244,111 ) Non-GAAP net income $ 81,031 $ 128,054 $ 364,899 $ 485,798 GAAP net income per share, basic $ 0.23 $ 1.20 $ 1.06 $ 2.32 GAAP net income per share, diluted $ 0.22 $ 1.15 $ 1.02 $ 2.21 Non-GAAP net income per share, basic $ 0.27 $ 0.43 $ 1.21 $ 1.63 Non-GAAP net income per share, diluted $ 0.26 $ 0.41 $ 1.16 $ 1.55 Shares used in computing net income per share, basic 304,338 299,409 302,584 297,892 Shares used in computing net income per share, diluted 315,030 312,443 315,009 312,803 (1) Non-cash stock-based compensation expense used for GAAP reporting in accordance with Accounting Standards Codification Topic 718, Compensation—Stock Compensation. (2) Represents the non-cash income tax benefit related to the release of substantially all of the valuation allowance against the company’s deferred tax assets on December 31, 2018. View source version on businesswire.com: https://www.businesswire.com/news/home/20200225006003/en/ Contacts Chris Senner Chief Financial Officer Exelixis, Inc. 650-837-7240 csenner@exelixis.com
-非 GAAP 2019年第四季度摊薄 EPS 为0.26美元,2019年全年为1.16美元- -东部时间(Eastern Time)下午5时正举行电话会议及网上直播- Exelixis , Inc .( Nasdaq : EXEL )今天公布了2019年第四季度和全年的财务业绩,并提供了实现其关键企业目标的最新进展以及商业和临床开发里程碑。 Exelixis 公司总裁兼首席执行官 Michael M . Morrissey 博士说:“ Exelixis 公司在2019年实现了强劲的财务业绩,总收入大幅增长,并扩大了 Caboxinib 特许经营权,这是第一次超过10亿美元的年度全球净收入。“我们以强劲的资产负债表和盈利业务结束了该公司25周年纪念活动。这使得 Exelixis 能够继续我们的持续投资,将 cabocinib 专营权扩大到新的适应症,并通过有针对性的业务开发和内部药物发现活动建立差异化的肿瘤资产管道。 Morrissey 博士继续说:“我们在2019年对我们业务的商业、临床和发现组件的执行,帮助 Exelixis 在2020年奠定了坚实的基础,预计未来两年将有一系列影响深远的临床和监管里程碑。我们在2019年结束了九个正在进行的卡布沙替尼的潜在标签支持试验,另外三个关键试验预计将在今年启动。我们预计,到2020年,这些正在进行的试验中有6项的数据将被重新输入,到2021年底,可能会有多达4项新批准的卡布沙替尼特许经营权的适应症,同时在今年重建我们的肿瘤管道,将有多达3项新的研究新药申报。整个 Exelixis 团队一直致力于集中精力并决心将业务推进到这一点,我们正果断采取行动,执行我们公司的优先事项,并为需要的癌症患者提供新的药物。” 二零一九年第四季及全年财务业绩 (详情请参阅下文呈列基准) 截至2019年12月31日止季度及年度的总收入分别为2.403亿美元及9.678亿美元,而2018年同期则为2.286亿美元及8.538亿美元。 截至2019年12月31日止季度及年度的总收入包括产品净收入分别为194.9百万美元及760.0百万美元,而2018年同期则为176.2百万美元及619.3百万美元。净产品收入的增长反映了美国 CABOMETYX ®( cabocinib )在治疗晚期肾细胞癌( RCC )患者方面的持续增长,以及美国推出 CABOMETYX 用于治疗先前接受索拉非尼治疗的肝癌患者,在美国食品药品监督管理局(Food and Drug Administration)( FDA )于2019年1月批准之后。 截至2019年12月31日止季度及年度的总收入分别包括协作收入4540万美元及2.078亿美元,而2018年同期则分别为5240万美元及2.345亿美元。协作收入减少主要是因为确认与里程碑相关的收入减少。这些合作收入的减少被主要来自 Exelixis 合作伙伴 Ipsen 在美国以外的与 caboxinib 相关的收入的较高特许权使用费收入部分抵消。 截至2019年12月31日止季度及年度的研发费用分别为94.4百万美元及337.0百万美元,而2018年同期为57.3百万美元及182.3百万美元。研发费用增加主要与临床试验费用、许可及其他协作费用及人员费用增加有关。临床试验费用增加的主要原因是与卡波西替尼临床试验方案扩展相关的费用,包括 CheckMate 9ER 、 COSMIC-311、 COSMIC-312、 COSMIC-313和 COSMIC-021。许可证和其他协作成本的增加主要是因为与许可内技术相关的合作伙伴的发现活动增加。人事费用的增加主要是由于支持 Exelixis 扩大发现和开发工作的员工人数增加。 截至2019年12月31日止季度及年度的销售、总务及管理费用分别为58.0百万美元及228.2百万美元,而2018年同期则为52.4百万美元及206.4百万美元。销售、一般及行政开支增加主要与人事开支及以股份为基础的薪酬增加有关,部分由公司捐赠减少所抵销。人事费用增加的主要原因是支持 Exelixis 商业和研发组织的行政人员增加。股票薪酬增加主要是由于员工人数增加,以及2018年授予的部分已归属或预计将归属于特定业绩目标实现的限制性股票单位的费用确认。 截至2019年12月31日止季度及年度的所得税拨备分别为16.3百万美元及77.1百万美元,而2018年可比期间的所得税福利为243.7百万美元及238.0百万美元。与 Exelixis 截至2018年12月31日止季度及年度的除税前收入相关的所得税拨备,已由其经营亏损结转净额及其他递延税项资产的估值拨备所抵销。于2018年12月31日, Exelixis 于 Exelixis 确定将变现该等递延税项资产的可能性较大后,就 Exelixis 的递延税项资产释放绝大部分剩余估值拨备。 截至2019年12月31日止季度的 GAAP 净利润为6,870万美元,或每股0.23美元,基本和每股0.22美元被摊薄,而2018年可比期间的一般公认会计原则(GAAP)净利润为3.601亿美元,即每股1.20美元,基本和每股1.15美元被摊薄。截至2019年12月31日止年度的 GAAP 净利润为3.21亿美元,即每股1.06美元,基本和每股1.02美元被摊薄,而2018年可比期间的一般公认会计原则(GAAP)净利润为6.901亿美元,即每股2.32美元,基本和每股2.21美元被摊薄。净收入的减少主要与 Exelixis 递延税项资产的几乎所有剩余估值准备金的2018年释放、研发费用的增加和里程碑收入的减少有关;这些变化被净产品收入的增加部分抵消。 截至2019年12月31日止季度的非 GAAP 净收益为81.0百万美元,或每股0.27美元,基本和每股0.26美元被摊薄,而2018年可比期间的非非一般公认会计原则(non-GAAP)净收益为128.1百万美元,即每股0.43美元,基本和每股0.41美元被摊薄。截至2019年12月31日止年度的非 GAAP 净收益为3.649亿美元,即基本每股1.21美元,稀释后每股1.16美元,而2018年可比期间的非 GAAP 净收益为4.858亿美元,即基本每股1.63美元,摊薄后每股1.55美元。非 GAAP 净收入不包括与释放上述截至2018年12月31日公司递延所得税资产的几乎所有估值准备金和股票薪酬相关的非现金所得税福利,并根据相关所得税影响进行调整。 截至2019年12月31日,现金和投资总额为14亿美元,而截至2018年12月31日为9亿美元。 非 GAAP 财务指标 为了补充 Exelixis 按照美国公认会计准则(一般公认会计原则(GAAP))列报的财务业绩, Exelixis 列报了非非一般公认会计原则(non-GAAP)净利润(以及相关的每股指标)。其中不包括根据所有列报期间的相关所得税影响进行调整的一般公认会计原则(GAAP)净收入(以及相关的每股收益衡量)与释放2018年公司递延所得税资产的几乎所有估值准备金和股票补偿费用相关的非现金所得税收益。 Exelixis 认为,这些非非一般公认会计原则(non-GAAP)财务指标的列报为投资者提供了有用的补充信息,并促进了投资者的进一步分析。特别是, Exelixis 认为,这些非非一般公认会计原则(non-GAAP)财务指标与按照一般公认会计原则(GAAP)编制的财务信息一起考虑,可以增强投资者和分析师对 Exelixis 各期业绩进行有意义比较的能力,并确定 Exelixis 业务的经营趋势。Exelixis 已将这些项目排除在外,因为它们是非现金项目,由于与所述期间的经营业绩没有直接或立即相关的变化,这些项目在不同时期可能会有很大差异。Exelixis 还定期在内部使用这些非非一般公认会计原则(non-GAAP)财务指标来了解、管理和评估其业务并做出经营决策。 这些非非一般公认会计原则(non-GAAP)财务指标是根据一般公认会计原则(GAAP)编制的财务绩效指标的补充,而不是替代或优于这些指标。Exelixis 鼓励投资者仔细考虑其根据一般公认会计原则(GAAP)的结果,以及其补充非非一般公认会计原则(non-GAAP)财务信息和这些演示文稿之间的对账,以更全面地了解 Exelixis 的业务。非一般公认会计原则(non-GAAP)和非一般公认会计原则(GAAP)结果之间的对账在本新闻稿的表格中列出。 2020年财务指引 Exelixis 为2020财政年度提供以下财务指导: 总收入 8.5亿至9亿元 产品净收入 7.25亿元至7.75亿元 销货成本 4%-5%的净产品收入 研究及发展开支(1) 4.6亿元至5亿元 销售、总务及管理费用(2) 2.3亿至2.5亿元 实际税率 20%-22% 现金和投资(3) 15亿至16亿元 (1) 包括2500万美元的非现金股票补偿费用。 (2) 包括3000万美元的非现金股票补偿费用。 (3) 此现金指导不包括任何潜在的新业务开发活动,这仍然是 Exelixis 的一个关键优先事项,因为它继续朝着成为多产品肿瘤公司的方向发展。 Cabocinib 高地 Cabocinib 2019年全年特许经营净收入超过全球10亿美元。2019年第四季度,美国 cabocinib 专营权产生的净产品收入为1.949亿美元,同比增长10.6%, CABOMETYX 净产品收入为1.811亿美元, COMETRIQ ®( cabocinib )净产品收入为1380万美元。Exelixis 在2019年第四季度基于 Ipsen 的 Caboxinib 相关收入获得了1,700万美元的特许权使用费收入。Caboxinib 继续扩大其全球足迹,目前分别在52个国家和49个国家获得批准和商业化。2019年, Exelixis 及其合作伙伴 Ipsen 产生的全球 cabocinib 专营权净收入在一个日历年度首次超过10亿美元。 加拿大卫生部批准 CABOMETYX 用于晚期 RCC 成人一线治疗。2019年10月, Ipsen 宣布加拿大卫生部批准 CABOMETYX 用于晚期 RCC 成人的一线治疗。根据与 Ipsen 的合作协议, Exelixis 获得了加拿大卫生部批准的300万美元里程碑付款,并于2019年第四季度确认为收入。CABOMETYX 最初于2018年9月在加拿大获得批准用于治疗已接受血管内皮生长因子靶向治疗的晚期 RCC 成人。 加拿大卫生部批准 CABOMETYX 用于治疗先前治疗的晚期 HCC 患者。2019年11月, Ipsen 宣布加拿大卫生部批准 CABOMETYX 用于治疗以前用索拉非尼治疗的 HCC 患者。根据与 Ipsen 的合作协议, Exelixis 获得了加拿大卫生部批准的200万美元里程碑付款,并于2019年第四季度确认为收入。 与 F.Hoffmann-La 罗氏(Roche) Ltd .( Roche )进行三期三期联合试验的临床合作公告。2019年12月, Exelixis 宣布与罗氏公司达成合作协议,评估卡布沙替尼与罗氏(Roche)公司 PD-L1免疫检查点抑制剂 atezolizumab 联合应用于局部晚期或转移性实体肿瘤患者。该临床项目将由两家公司共同出资,预计将包括三个阶段的关键试验,先进的非小细胞肺癌,转移性蓖麻抗前列腺癌( mCRPC )和 RCC 。 卡布沙替尼联合阿齐唑仑单抗治疗晚期实体瘤1b 期 COSMIC-021期前列腺癌联合激素的进一步扩展.2020年1月, Exelixis 宣布,基于持续鼓舞人心的疗效和安全性数据,公司计划进一步扩大 COSMIC-021的 mCRPC 队列,即卡索替尼联合阿替唑单抗治疗局部晚期或转移性实体瘤的1b 期试验。这一队列在2019年7月从30名扩大到80名,现在将包括多达130名患者。 卡布沙替尼联合尼伐单抗治疗晚期肝癌的临床研究。2020年1月, Exelixis 宣布晚期 HCC 中卡布沙替尼与尼伐单抗联合或不联合使用吡啶umab 的1/2期临床试验结果。1月24日星期五,美国临床肿瘤学会( ASCO )在加利福尼亚州旧金山举行的胃肠癌研讨会上公布了 CheckMate 040试验的卡波西替尼联合队列研究的数据。这些数据支持 Exelixis 的临床开发计划 cabocinib 加上先进 HCC 的免疫检查点抑制剂,包括正在进行的 COSMIC-312三期 cabocinib 联合 atezoliumab 与 sorafenib 的关键试验。 在 ASCO 的泌尿生殖癌研讨会上宣读第1b 期 COSMIC-021试验 mCRPC cohort 。2020年2月, Exelixis 公布了对 MIC-021的 mCRPC 队列进行中期分析的积极有效性和安全性结果。这些数据是在2月13日(星期四)在 ASCO 的 GenitouroCancers 研讨会上公布的。根据 FDA 的监管反馈,如果 COSMIC-021正在进行的 mCRPC 扩展组的临床数据支持, Exelixis 打算最早于2021年向 FDA 提交 mCRPC 适应症的加速审批。 企业更新 Exelixis and Invena , Inc .( Invena )扩大合作,侧重于发现和开发治疗癌症的多特异性抗体。2019年10月, Exelixis 扩大了与 Invenga 的合作,包括针对6个额外目标开发新的绑定程序。根据扩大合作协议的条款, Exelixis 将有机会使用这些粘合剂,以 Exelixis 的选择,基于 Invena 的 B-Body ™技术平台或与其他平台和格式生成多特异性抗体。 Exelixis 诉 CABOMETYX 公司诉简略新药申请( ANDA )案.2019年10月, Exelixis 向 MSN Pharmaceuticals , Inc .( MSN )提起专利侵权诉讼,此前收到 MSN 发出的第 IV 段认证通知书,要求 FDA 批准上市 CABOMETYX 片剂的仿制药, CABOMETYX 物质专利组合物到期后,美国专利 No.7,579,473,将于2026年8月14日到期。Exelixis 正在寻求,除其他救济外,一项命令,任何 FDA 批准 ANDA 的生效日期将不早于美国专利 No.8,877,776在2030年10月8日到期和公平救济禁止 MSN 侵犯该专利。 Exelixis 的合作者第一三共(Daiichi Sankyo) Company , Limited (第一三共(Daiichi Sankyo))宣布艾沙酮在糖尿病肾病患者3期临床试验中的阳性结果。2019年11月, Exelixis 宣布其合作伙伴第一三共(Daiichi Sankyo)报告了糖尿病性肾病患者艾塞龙3期关键试验的阳性结果。艾司他酮是 Exelixis 与第一三共(Daiichi Sankyo)先前的研究合作中发现的一种新的矿化激素受体阻滞剂,随后由第一三共(Daiichi Sankyo)开发并商业化。艾司他酮已获准作为日本高血压患者的治疗药物,在日本市场上以 MINNEBRO ®片剂上市。第一三共(Daiichi Sankyo)全权负责 Saxerenone 的开发和商业化, Exelixis 仍有资格获得重大的商业化里程碑,以及在销售过程中获得较低的两位数特许权使用费。 发表 IMspire 的正面结果150。2019年12月, Exelixis 宣布了 IMspire150的阳性结果,即在先前未治疗的 BRAFV600突变阳性晚期黑色素瘤患者中,进行了第三阶段试验 atezolizumab 、 cobimetinib 和 vemurafenib 。基因泰克(Genentech), Inc .(罗氏(Roche)集团的成员)、 Exelixis 的合作者和 IMspire150试验的发起人告诉 Exelixis ,该研究满足了无进展生存的主要终点。结果将在即将召开的医学会议上发表,并与世界各地的卫生当局讨论,包括 FDA 和欧洲药品管理局。 执行纲要2020-21年的主要优先事项和预期里程碑。2020年1月, Exelixis 宣布了其2020-21年的关键优先事项和预期里程碑,包括从多达六个正在进行的具有标签授权潜力的试验中产生一线数据,启动至少三个新的关键试验,并推进其中期和早期管道,到2020年最多有三个新的研究新药申报。公司拟进行适当的投资,以最大限度地扩大 CABOMETYX 的临床开发机会, Exelixis 认为,到2021年底,可能会导致多达4个额外的批准适应症。同时,通过内部药物发现和业务发展,努力推进一系列潜在的新 Exelixis 药物。 呈报基准 Exelixis 采用了52周或53周的会计年度,通常在最接近12月31日的周五结束。为方便起见,本新闻稿中截至2020年1月3日及2018年12月28日止财政期间的参考资料分别显示截至2019年12月31日及2018年12月31日止财政期间。截至2019年12月31日止期间为14周财政季度及53周财政年度,而于2018年同期则为13周财政季度及52周财政年度。 电话会议和网络广播 Exelixis 管理层将讨论公司2019年第四季度及全年的财务业绩,并于2020年2月25日(星期二)下午5:00 PT /2:00 PT 开始的电话会议期间提供一般业务更新。 要访问网络广播链接,请登录 www.exixis.com ,然后进入“投资者与媒体”标题下的“新闻与事件/事件日历”页面。请在电话会议召开前至少15分钟连接公司网站,以确保有足够的时间下载任何可能需要收听网络广播的软件。另外,请致电855-793-2457(国内)或631-485-4921(国际)并提供电话会议密码9168158通过电话加入。 电话回放将于2020年2月27日下午8:00前开放。电话重播的接入号码为:855-859-2056(国内)和404-537-3406(国际);密码为9168158。还将在 www.exixis.com 上存档一年的网络直播重播。 关于 Exelixis Exelixis , Inc .( Nasdaq : EXEL )成立于1994年,是一家商业上成功的、以肿瘤学为重点的生物技术公司,致力于加快发现、开发和商业化治疗难治性癌症的新药。继早期在模型系统遗传学方面的工作之后,我们建立了广泛的药物发现和开发平台,为我们继续努力为需要的患者提供新的癌症治疗奠定了基础。我们的发现工作已经产生了四个批准的产品, CABOMETYX ®(卡布沙替尼)、 COMETRIQ ®(卡布沙替尼)、 COTELLIC ®( cobimetinib )和 MINNEBRO ®(艾塞申烯),并且我们已经与领先的制药公司建立了合作关系,将这些重要的药物带给全球的患者。在我们营销产品和合作的收入支持下,我们致力于审慎地对我们的业务进行再投资,以最大限度地发挥我们管道的潜力。我们正在以有针对性的业务开发活动和内部药物发现补充现有的治疗资产——所有这些都是为了提供下一代 Exelixis 药物,帮助患者康复更强,寿命更长。Exelixis 是标准普尔( S & P ) MidCap 400指数的成员,该指数衡量盈利的中型企业的业绩。有关 Exelixis 的更多信息,请访问 www.exixis.com ,在 Twitter 上关注@ Exelixis Inc ,或类似于 Facebook 上的 Exelixis , Inc .。 前瞻性陈述 本新闻稿包含前瞻性声明,包括但不限于与以下相关的声明: Exelixis 预期在未来两年内实现一系列临床和监管里程碑的影响,包括其正在进行的九项潜在的卡布沙替尼标签支持试验中的六项数据的读出。到2021年底,可能会有多达四个新的批准的卡布沙替尼特许经营适应症,启动三个非小细胞肺癌的额外关键试验,mCRPC 和 RCC 计划在2020年重建 Exelixis 的肿瘤管道,最多在2020年建立三个新的研究新药备案; Exelixis 更新了2020年的财务指导; Exelixis 计划进一步扩大 mCRPC 的 COSMIC-021队列,将最多130名患者纳入其中; Exelixis 计划在2021年尽早向 FDA 提交申请,以加速批准卡波西汀和替佐木单抗联合应用于 mCRPC 适应症; Exelixis 根据其与 Invensa 的合作协议承担的义务; Exelixis 获得商业化重大里程碑的资格。以及 MINNEBRO 销售的低两位数专利使用费;基因泰克(Genentech)计划在即将召开的医学会议上展示 IMspire 150数据,并与世界各地的卫生当局讨论数据; Exelixis 计划再投资于其业务,以最大限度地发挥公司管道的潜力,包括通过有针对性的业务开发活动和内部药物发现。任何涉及未来事件或情况的预期、预测或其他特征的陈述都是前瞻性陈述,并基于 Exelixis 的当前计划、假设、信念、预期、估计和预测。前瞻性陈述涉及风险和不确定性。由于这些风险和不确定性,实际结果和事件发生的时间可能与前瞻性陈述中预期的结果存在重大差异,这些风险和不确定性包括但不限于:批准区域内 CABOMETYX 、 COMETRIQ 、 COTELLIC 和 MINNEBRO 的市场接受程度;Exelixis 获得或维持这些产品的覆盖范围和偿付能力; CABOMETYX 、 COMETRIQ 、 COTELLIC 和 MINNEBRO 相对于竞争产品的有效性;与 Exelixis 商业化、研发、许可或收购产品候选人相关的成本水平;和其他活动;在参考时间的数据可用性;单独或与其他疗法相结合的卡布沙替尼和其他 Exelixis 产品候选者的潜在失败,以证明临床试验的安全性和/或有效性;药物发现和产品开发过程中固有的不确定性,包括不断变化的法规要求,比预期的患者注册速度慢,无法确定足够数量的临床试验场地或第三方科学顾问和承包商的有限可用性; Exelixis 依赖其与合作伙伴的关系,包括在新适应症中寻求对合作化合物的监管批准;它们遵守相关合作协定规定的义务,并对完成临床试验或在批准的领土上成功地将伙伴化合物商业化所需的资源进行投资;监管审查和批准程序,包括以下风险:监管部门可能不会批准 Exelixis 的产品作为寻求批准的适应症的治疗方法; Exelixis 继续遵守适用的法律和法规要求;由于出现不良安全事件或对评估 cabocinib 、 cobimetinib 或 esxerenone 的临床试验进行额外数据分析而可能产生的意外担忧; Exelixis 对第三方供应商生产和供应其产品的依赖; Exelixis 保护其知识产权的能力;市场竞争,包括竞争对手在2019年10月30日向美国证券交易委员会( SEC )提交的 Exelixis 《10-Q 季报》中的“风险因素”标题下讨论的可能获得 Exelixis 上市产品的仿制药版本的批准;经济和商业状况的变化;以及 Exelixis 未来向 SEC 提交的文件中讨论的其他因素,包括但不限于预期于2020年2月25日向 SEC 提交的10-K 季报中的 Exelixis 年度报告。本新闻稿中所有前瞻性陈述均基于截至本新闻稿发布之日 Exelixis 可获得的信息, Exelixis 不承担更新或修改本新闻稿中任何前瞻性陈述的义务。 Exelixis 、 Exelixis 徽标、 CABOMETYX 、 COMETRIQ 和 COTELLIC 均为美国注册商标。 MINNEBRO 为日本注册商标。 EXELIXIS , INC . 简明综合收益表 (以千计,每股金额除外) (未经审核) 截至十二月三十一日止三个月 截至十二月三十一日止年度 2019年 2018年 2019年 2018年 收入: 产品净收入 元 194,926 元 176,225 元 759,950 元 619,279 合作收入 45,384 52,377 207,825 234,547 总收入 240,310 228,602 967,775 853,826 营业费用: 销货成本 10,520 7,352 33,097 26348 研究与开发 94,448 57,271 336,964 182,257 销售、总务和管理 58,026 52,377 228,244 206,366 经营费用总额 162,994 117,000 598,305 414,971 营业收入 77,316 111,602 369,470 438,855 其他收益(费用),净额: 利息收入 7,706 4,741 27,959 12,840 其他,净额 (8) (二) 29 680 397 其他收入(支出)合计,净额 7,698 4,770 28,639 13,237 所得税前收入 85,014 116,372 398,109 452,092 所得税拨备(福利) 16,271 (243,717 (二) 77,097 (237,978) (二) 净收入 元 68,743 元 360,089 元 321,012 元 690,070 每股净收益,基本 元 0.23 元 1.20 元 1.06 元 2.32 摊薄每股净收益 元 0.22 元 1.15 元 1.02 元 2.21 用于计算每股净收益的份额,基本 304,338 299,409 302,584 297,892 用于计算每股净收益的股份,摊薄 315,030 312,443 315,009 312,803 EXELIXIS , INC . 简明综合资产负债表及结算日 (千人) (未经审核) 12月31日, 12月31日, 2019年 2018年 现金和投资 元 1,388,628 元 851,621 营运资金 元 868,444 元 791,544 总资产 元 1,885,670 元 1,422,286 股东权益合计 元 1,685,970 元 1,287,453 EXELIXIS , INC . 将一般公认会计原则(GAAP)净收益重新确认为非 GAAP 净收益 (以千计,每股金额除外) (未经审核) 截至十二月三十一日止三个月 截至十二月三十一日止年度 2019年 2018年 2019年 2018年 一般公认会计原则(GAAP)净收入 元 68,743 元 360,089 元 321,012 元 690,070 调整事项: 股份补偿-研发费用(1) 5,629 4,013 19,374 13,115 股份补偿-销售、一般及行政开支(1) 10,226 8,283 37,228 27,511 上述调整的所得税影响 (3,567) (二) (220) (二) (12,715 (二) (787) (二) 因发放估值津贴而产生的所得税利益(2) - (244,111 (二) - (244,111 (二) 非 GAAP 净收入 元 81,031 元 128,054 元 364,899 元 485,798 一般公认会计原则(GAAP)每股净收益,基本 元 0.23 元 1.20 元 1.06 元 2.32 一般公认会计原则(GAAP)每股净收益,摊薄 元 0.22 元 1.15 元 1.02 元 2.21 非 GAAP 每股净收益,基本 元 0.27 元 0.43 元 1.21 元 1.63 非 GAAP 每股净收益,摊薄 元 0.26 元 0.41 元 1.16 元 1.55 用于计算每股净收益的份额,基本 304,338 299,409 302,584 297,892 用于计算每股净收益的股份,摊薄 315,030 312,443 315,009 312,803 (1) 非现金股票补偿费用用于根据会计准则规范第718题,补偿-股票补偿的一般公认会计原则(GAAP)报告。 (2) 表示与解除2018年12月31日公司递延所得税资产实质上所有的估值优惠相关的非现金所得税利益。 查看 businesswire 上的源代码。http://www.businesswire.com/news/home/20200225006003/en/ 联系人 Chris Senner 首席财务官 Exelixis , Inc .650-837-7240 csenner @ exixis.com

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