Exelixis Announces First Quarter 2023 Financial Results and Provides Corporate Update
- Total Revenues of
- GAAP Diluted EPS of
- Conference Call and Webcast Today at 5:00 PM Eastern Time -
“The Exelixis team continued to execute on our key priorities and made significant progress in advancing our commercial business and our growing pipeline,” said Michael M. Morrissey, Ph.D., President and Chief Executive Officer, Exelixis. “CABOMETYX® maintained its status as the leading tyrosine kinase inhibitor in renal cell carcinoma in the first quarter, driven by its use in combination with nivolumab in the first-line setting. We’ve made important progress across our pipeline programs, including advancing the STELLAR-303 and STELLAR-304 phase 3 trials for zanzalintinib, as well as single-agent and combination dose-escalation cohorts of the phase 1 trial of XB002. We are on track to initiate additional pivotal studies for zanzalintinib in 2023 and are focused on accelerating XB002 into full development by year-end.”
Dr. Morrissey continued: “Our collaborations with Cybrexa and Sairopa also made steady progress. Sairopa received clearance of its Investigational New Drug application for ADU-1805 from the
First Quarter 2023 Financial Results
Total revenues for the quarter ended March 31, 2023 were
Total revenues for the quarter ended March 31, 2023 included net product revenues of
Collaboration revenues, composed of license revenues and collaboration services revenues, were
Research and development expenses for the quarter ended March 31, 2023 were
Selling, general and administrative expenses for the quarter ended March 31, 2023 were
Provision for income taxes for the quarter ended March 31, 2023 was
GAAP net income for the quarter ended March 31, 2023 was
Non-GAAP net income for the quarter ended March 31, 2023 was
Non-GAAP Financial Measures
To supplement Exelixis’ financial results presented in accordance with
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.
2023 Financial Guidance
Exelixis is maintaining the previously provided financial guidance for fiscal year 2023:
Total revenues |
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Net product revenues |
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Cost of goods sold |
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Research and development expenses (1) |
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Selling, general and administrative expenses (2) |
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Effective tax rate |
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(1) |
Includes |
(2) |
Includes |
Cabozantinib Highlights
Cabozantinib Franchise Net Product Revenues and Royalties. Net product revenues generated by the cabozantinib franchise in the
Cabozantinib Data at the 2023 American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium (ASCO GU 2023). In February, cabozantinib was the subject of multiple data presentations at ASCO GU 2023, held from February 16-18, 2023. Notable presentations included: 44-month median follow-up data and biomarker analyses from CheckMate -9ER, the phase 3 pivotal trial of cabozantinib in combination with nivolumab; outcomes by International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) risk score in COSMIC-313, the phase 3 pivotal trial of cabozantinib, nivolumab and ipilimumab; and extended follow-up results from a non-clear cell renal cell carcinoma (RCC) cohort of COSMIC-021, the ongoing phase 1b trial of cabozantinib in combination with atezolizumab.
Cabozantinib Data Presentations at the 2023 ASCO Annual Meeting. In June 2023, cabozantinib will be the subject of 22 presentations at this year’s ASCO Annual Meeting, which is being held from June 2-6 in
Corporate Updates
Announcement of Key Priorities and Anticipated Milestones for 2023. In January 2023, Exelixis announced its key priorities and anticipated milestones for 2023, including: pivotal data readouts from the ongoing phase 3 studies evaluating the combination of cabozantinib with atezolizumab in patients with forms of metastatic castration-resistant prostate cancer (CONTACT-02) and RCC (CONTACT-03), the latter of which has subsequently occurred, and the next overall survival (OS) analysis from the phase 3 COSMIC-313 pivotal study for cabozantinib; expansion of the pivotal development program for zanzalintinib with multiple new phase 3 pivotal trial initiations; acceleration of the XB002 clinical program into full development by year-end; advancement of the XL102 QUARTZ-101 phase 1 study into the tumor-specific cohort-expansion stage and in planned combination cohorts; in collaboration with partner Cybrexa, progression of the phase 1 clinical study for CBX-12, including dose-expansion cohorts; expected filing of an Investigational New Drug application (IND) for ADU-1805 with the
Cabozantinib Abbreviated New Drug Application (ANDA) Litigation Against MSN Pharmaceuticals, Inc. (MSN). In January 2023, the
Announcement of
Pipeline Highlights
Exelixis and Sairopa Announce FDA Clearance of IND for ADU-1805 in Patients with Advanced Solid Tumors. In February, Exelixis and Sairopa announced FDA clearance of Sairopa’s IND to evaluate the safety and pharmacokinetics in a Phase 1 clinical trial of ADU-1805 in adults with advanced solid tumors, which has since been initiated. As a monoclonal antibody active against all human alleles of SIRPα, ADU-1805 has the potential to address a broader patient population than other SIRPα-directed therapies. By blocking SIRPα, a significant immune-suppressive component of the tumor microenvironment, ADU-1805 has the potential to improve the immune system’s ability to attack tumors. Under the terms of the clinical development and option agreement announced in November 2022, Exelixis has the option to obtain an exclusive, worldwide license to develop and commercialize ADU-1805 and other anti-SIRPα antibodies upon review of data from prespecified phase 1 clinical studies to be completed by Sairopa during the option period. This IND clearance triggered a
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 period ended April 1, 2022 is indicated as being as of and for the period ended March 31, 2022.
Conference Call and Webcast
Exelixis management will discuss the company’s financial results for the first quarter of 2023 and provide a general business update during a conference call beginning at 5:00 p.m. ET / 2:00 p.m. PT today, Tuesday, May 9, 2023.
To access the conference call, please register using this link. Upon registration, a dial-in number and unique PIN will be provided to join the call. To access the live 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. A webcast replay of the conference call will also be archived on www.exelixis.com for one year.
About Exelixis
Exelixis is a globally ambitious oncology company innovating next-generation medicines and regimens at the forefront of cancer care. Powered by bi-coastal centers of discovery and development excellence, we are rapidly evolving our product portfolio to target an expanding range of tumor types and indications with our clinically differentiated pipeline of small molecules, antibody-drug conjugates and other biotherapeutics. This comprehensive approach harnesses decades of robust investment in our science and partnerships to advance our investigational programs and extend the impact of our flagship commercial product, CABOMETYX® (cabozantinib). Exelixis is driven by a bold scientific pursuit to create transformational treatments that give more patients hope for the future. For information about the company and its mission to help cancer patients recover stronger and live longer, visit www.exelixis.com, follow @ExelixisInc on Twitter, like Exelixis, Inc. on Facebook and follow Exelixis on LinkedIn.
Forward-Looking Statements
This press release contains forward-looking statements, including, without limitation, statements related to: Exelixis’ research and development expectations for 2023, including initiating additional pivotal studies for zanzalintinib and, by year-end, accelerating XB002 into full development; Exelixis’ expectation that updated phase 1 data for CBX-12 will be presented at the ASCO Annual Meeting in June 2023; Exelixis’ plan to repurchase up to
Exelixis, the Exelixis logo, CABOMETYX and COMETRIQ are registered trademarks of Exelixis, Inc.
EXELIXIS, INC. CONDENSED CONSOLIDATED STATEMENTS OF INCOME (in thousands, except per share amounts) (unaudited) |
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Three Months Ended March 31, |
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2023 |
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2022 |
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Revenues: |
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Net product revenues |
$ |
363,400 |
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|
$ |
310,298 |
|
License revenues |
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38,292 |
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32,067 |
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Collaboration services revenues |
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7,096 |
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13,615 |
|
Total revenues |
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408,788 |
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355,980 |
|
Operating expenses: |
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Cost of goods sold |
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14,315 |
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13,203 |
|
Research and development |
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234,246 |
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156,671 |
|
Selling, general and administrative |
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131,397 |
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102,863 |
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Total operating expenses |
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379,958 |
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272,737 |
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Income from operations |
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28,830 |
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83,243 |
|
Interest income |
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19,502 |
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|
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1,822 |
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Other income (expense), net |
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(54 |
) |
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|
164 |
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Income before income taxes |
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48,278 |
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85,229 |
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Provision for income taxes |
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8,250 |
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16,656 |
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Net income |
$ |
40,028 |
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$ |
68,573 |
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Net income per share: |
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Basic |
$ |
0.12 |
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$ |
0.21 |
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Diluted |
$ |
0.12 |
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$ |
0.21 |
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Weighted-average common shares outstanding: |
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Basic |
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324,420 |
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319,582 |
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Diluted |
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326,279 |
|
|
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323,289 |
|
EXELIXIS, INC. RECONCILIATION OF GAAP NET INCOME TO NON-GAAP NET INCOME (in thousands, except per share amounts) (unaudited) |
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Three Months Ended March 31, |
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2023 |
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2022 |
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GAAP net income |
$ |
40,028 |
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$ |
68,573 |
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Adjustments: |
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Stock-based compensation - research and development expenses (1) |
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3,252 |
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8,899 |
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Stock-based compensation - selling, general and administrative expenses (1) |
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13,409 |
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10,860 |
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Income tax effect of the above adjustments |
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(3,861 |
) |
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(4,439 |
) |
Non-GAAP net income |
$ |
52,828 |
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$ |
83,893 |
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GAAP net income per share: |
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Basic |
$ |
0.12 |
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$ |
0.21 |
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Diluted |
$ |
0.12 |
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$ |
0.21 |
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Non-GAAP net income per share: |
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Basic |
$ |
0.16 |
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$ |
0.26 |
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Diluted |
$ |
0.16 |
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$ |
0.26 |
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Weighted-average common shares outstanding: |
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Basic |
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324,420 |
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|
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319,582 |
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Diluted |
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326,279 |
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323,289 |
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____________________
(1) |
Non-cash stock-based compensation expense used for GAAP reporting in accordance with Accounting Standards Codification Topic 718, Compensation—Stock Compensation. |
View source version on businesswire.com: https://www.businesswire.com/news/home/20230509005349/en/
Chris Senner
Chief Financial Officer
Exelixis, Inc.
650-837-7240
csenner@exelixis.com
Susan Hubbard
EVP, Public Affairs & Investor Relations
Exelixis, Inc.
650-837-8194
shubbard@exelixis.com
Source: Exelixis, Inc.