Exelixis Announces Second Quarter 2023 Financial Results and Provides Corporate Update
- Total revenues increased by 12.1% compared to the same period last year.
- Net product revenues increased to $409.6 million, driven by an increase in sales volume and net selling price.
- CABOMETYX maintained its status as the leading tyrosine kinase inhibitor for the treatment of renal cell carcinoma.
- Progress in the development of zanzalintinib and XB002, Exelixis' next-generation tyrosine kinase inhibitor and antibody-drug conjugate, respectively.
- Enrollment completed in multiple expansion cohorts of the phase 1 STELLAR-001 study for zanzalintinib.
- Advancement of the phase 1 JEWEL-101 study for XB002, with the goal of moving the program into full development by year-end.
- Positive clinical data update from the CBX-12 phase 1 program by Cybrexa at the ASCO Annual Meeting in June.
- Decrease in collaboration revenues due to decreases in milestone-related revenues and development cost reimbursements.
- Increase in research and development expenses primarily related to manufacturing costs and personnel expenses.
- Increase in selling, general, and administrative expenses primarily related to legal and advisory fees related to a proxy contest.
- Total Revenues of
- GAAP Diluted EPS of
- Conference Call and Webcast Today at 5:00 PM Eastern Time -
“In the second quarter of 2023, the Exelixis team continued to make steady progress both on our commercial business and our rapidly advancing pipeline,” said Michael M. Morrissey, Ph.D., President and Chief Executive Officer, Exelixis. “It was another strong quarter for CABOMETYX®, which maintained its status as the leading tyrosine kinase inhibitor for the treatment of renal cell carcinoma, again driven by its use in combination with nivolumab in the first-line setting. Revenues from CABOMETYX and the broader cabozantinib franchise directly support the build-out of our differentiated pipeline, including zanzalintinib, our next-generation tyrosine kinase inhibitor, and XB002, our most advanced antibody-drug conjugate. During and after the quarter, we completed enrollment in multiple expansion cohorts of the phase 1 STELLAR-001 study for zanzalintinib, progressed the ongoing phase 3 pivotal trials and furthered our plans for additional pivotal trials of the compound. We also continued to advance the phase 1 JEWEL-101 study for XB002, selecting the single-agent dose from the dose-escalation stage of the study and initiating the cohort expansion stage, with the goal of moving the program into full development before year end. Our clinical collaborations with Cybrexa and Sairopa also advanced, including Cybrexa’s recent clinical data update from the CBX-12 phase 1 program at the ASCO Annual Meeting in June.”
Dr. Morrissey continued: “As we move through the second half of this year, we have much to look forward to, including the readout of the phase 3 CONTACT-02 study of cabozantinib and atezolizumab in patients with prostate cancer, the next overall survival analysis from the phase 3 COSMIC-313 study evaluating the triplet regimen of cabozantinib in combination with nivolumab and ipilimumab in renal cell carcinoma, and potential presentations of new data from our pipeline compounds. We also look forward to providing additional details around our discovery and development strategy and activities at an R&D Day planned for Tuesday, December 12th in
Second Quarter 2023 Financial Results
Total revenues for the quarter ended June 30, 2023 were
Total revenues for the quarter ended June 30, 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 June 30, 2023 were
Selling, general and administrative expenses for the quarter ended June 30, 2023 were
Provision for income taxes for the quarter ended June 30, 2023 was
GAAP net income for the quarter ended June 30, 2023 was
Non-GAAP net income for the quarter ended June 30, 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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____________________ |
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(1) |
Includes |
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(2) |
Includes |
Cabozantinib and Pipeline Highlights
Cabozantinib Franchise Net Product Revenues and Royalties. Net product revenues generated by the cabozantinib franchise in the
Cabozantinib and Pipeline Presentations at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting. In June, cabozantinib was the subject of 22 presentations at this year’s ASCO Annual Meeting, which was held from June 2-6 in
Corporate Highlights
Settlement of CABOMETYX Patent Litigation with Teva Pharmaceuticals. In July, Exelixis announced that it entered into a Settlement and License Agreement (Agreement) with Teva Pharmaceuticals Development, Inc. and Teva Pharmaceuticals
Share Repurchase Program. As of June 30, Exelixis has repurchased
Exelixis Board of Directors Refreshment Plan. In May, upon the conclusion of its 2023 Annual Meeting of Stockholders, Exelixis announced the election of three new members to its Board of Directors, Mr. Thomas Heyman, Mr. Robert Oliver, Jr. and Mr. David Johnson, following the departure of prior board members Mr. Carl Feldbaum, Dr. Vincent Marchesi and Dr. Lance Willsey. Exelixis thanks Mr. Feldbaum and Drs. Marchesi and Willsey for their commitment and contributions to Exelixis during their tenure, and looks forward to working collaboratively with Messrs. Heyman, Oliver and Johnson to advance the company’s mission to help patients recover stronger and live longer, and generate sustainable, long-term value for shareholders.
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 July 1, 2022 are indicated as being as of and for the periods ended June 30, 2022.
Conference Call and Webcast
Exelixis management will discuss the company’s financial results for the second 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, August 1, 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 Event Calendar page under the Investors & News 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 trials for zanzalintinib, moving the XB002 program into full development before year end, readouts from the phase 3 CONTACT-02 and COSMIC-313 studies, and potential presentations of new data from its pipeline compounds; Exelixis’ plans to provide additional details around its discovery and development strategy at an R&D Day in December 2023; Exelixis’ 2023 financial guidance; Exelixis’ and Teva’s obligations under the Agreement and Exelixis’ expectation that in accordance with the Agreement, Exelixis and Teva will terminate all ongoing Hatch-Waxman litigation regarding CABOMETYX patents; 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 June 30, |
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Six Months Ended June 30, |
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2023 |
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2022 |
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2023 |
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2022 |
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Revenues: |
|
|
|
|
|
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Net product revenues |
$ |
409,646 |
|
|
$ |
347,044 |
|
$ |
773,046 |
|
|
$ |
657,342 |
||
License revenues |
|
52,747 |
|
|
|
57,526 |
|
|
|
91,039 |
|
|
|
89,593 |
|
Collaboration services revenues |
|
7,455 |
|
|
|
14,857 |
|
|
|
14,551 |
|
|
|
28,472 |
|
Total revenues |
|
469,848 |
|
|
|
419,427 |
|
|
|
878,636 |
|
|
|
775,407 |
|
Operating expenses: |
|
|
|
|
|
|
|
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Cost of goods sold |
|
17,705 |
|
|
|
13,481 |
|
|
|
32,020 |
|
|
|
26,684 |
|
Research and development |
|
232,570 |
|
|
|
199,481 |
|
|
|
466,816 |
|
|
|
356,152 |
|
Selling, general and administrative |
|
141,723 |
|
|
|
122,759 |
|
|
|
273,120 |
|
|
|
225,622 |
|
Total operating expenses |
|
391,998 |
|
|
|
335,721 |
|
|
|
771,956 |
|
|
|
608,458 |
|
Income from operations |
|
77,850 |
|
|
|
83,706 |
|
|
|
106,680 |
|
|
|
166,949 |
|
Interest income |
|
22,541 |
|
|
|
4,757 |
|
|
|
42,043 |
|
|
|
6,579 |
|
Other income (expense), net |
|
(5 |
) |
|
|
45 |
|
|
|
(59 |
) |
|
|
209 |
|
Income before income taxes |
|
100,386 |
|
|
|
88,508 |
|
|
|
148,664 |
|
|
|
173,737 |
|
Provision for income taxes |
|
19,208 |
|
|
|
17,836 |
|
|
|
27,458 |
|
|
|
34,492 |
|
Net income |
$ |
81,178 |
|
|
$ |
70,672 |
|
|
$ |
121,206 |
|
|
$ |
139,245 |
|
Net income per share: |
|
|
|
|
|
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|
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Basic |
$ |
0.25 |
|
|
$ |
0.22 |
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|
$ |
0.37 |
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|
$ |
0.43 |
|
Diluted |
$ |
0.25 |
|
|
$ |
0.22 |
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|
$ |
0.37 |
|
|
$ |
0.43 |
|
Weighted-average common shares outstanding: |
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|
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Basic |
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324,205 |
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321,117 |
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324,312 |
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320,349 |
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Diluted |
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327,305 |
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|
|
324,904 |
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|
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326,792 |
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324,096 |
|
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 June 30, |
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Six Months Ended June 30, |
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2023 |
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2022 |
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2023 |
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2022 |
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GAAP net income |
$ |
81,178 |
|
|
$ |
70,672 |
|
|
$ |
121,206 |
|
|
$ |
139,245 |
|
Adjustments: |
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Stock-based compensation - research and development expenses (1) |
|
9,589 |
|
|
|
9,549 |
|
|
|
12,841 |
|
|
|
18,448 |
|
Stock-based compensation - selling, general and administrative expenses (1) |
|
15,311 |
|
|
|
15,073 |
|
|
|
28,720 |
|
|
|
25,933 |
|
Income tax effect of the above adjustments |
|
(5,781 |
) |
|
|
(5,569 |
) |
|
|
(9,642 |
) |
|
|
(10,008 |
) |
Non-GAAP net income |
$ |
100,297 |
|
|
$ |
89,725 |
|
|
$ |
153,125 |
|
|
$ |
173,618 |
|
GAAP net income per share: |
|
|
|
|
|
|
|
||||||||
Basic |
$ |
0.25 |
|
|
$ |
0.22 |
|
|
$ |
0.37 |
|
|
$ |
0.43 |
|
Diluted |
$ |
0.25 |
|
|
$ |
0.22 |
|
|
$ |
0.37 |
|
|
$ |
0.43 |
|
Non-GAAP net income per share: |
|
|
|
|
|
|
|
||||||||
Basic |
$ |
0.31 |
|
|
$ |
0.28 |
|
|
$ |
0.47 |
|
|
$ |
0.54 |
|
Diluted |
$ |
0.31 |
|
|
$ |
0.28 |
|
|
$ |
0.47 |
|
|
$ |
0.54 |
|
Weighted-average common shares outstanding: |
|
|
|
|
|
|
|
||||||||
Basic |
|
324,205 |
|
|
|
321,117 |
|
|
|
324,312 |
|
|
|
320,349 |
|
Diluted |
|
327,305 |
|
|
|
324,904 |
|
|
|
326,792 |
|
|
|
324,096 |
|
____________________ |
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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/20230801307436/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.
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