Press Release
Press Release
Exelixis Announces Third Quarter 2022 Financial Results and Provides Corporate Update
– Total Revenues of
– GAAP Diluted EPS of
– Conference Call and Webcast Today at
“Exelixis focused its efforts toward the progress and expansion of our clinical and early-stage pipeline during the third quarter of 2022, fueled by the growing revenues from our cabozantinib franchise,” said
Third Quarter 2022 Financial Results
Total revenues for the quarter ended
Total revenues for the quarter ended
Collaboration revenues, composed of license revenues and collaboration services revenues, were
Research and development expenses for the quarter ended
Selling, general and administrative expenses for the quarter ended
Provision for income taxes for the quarter ended
GAAP net income for the quarter ended
Non-GAAP net income for the quarter ended
Cash, cash equivalents, restricted cash equivalents and investments were
Non-GAAP Financial Measures
To supplement Exelixis’ financial results presented in accordance with
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.
2022 Financial Guidance
Total revenues |
|
|
Net product revenues |
|
|
Cost of goods sold |
|
~5% of net product revenues |
Research and development expenses (1) |
|
|
Selling, general and administrative expenses (2) |
|
|
Effective tax rate |
|
20% - 22% |
(1) |
|
Includes |
(2) |
|
Includes |
Cabozantinib Highlights
Cabozantinib Franchise Net Product Revenues and Royalties. Net product revenues generated by the cabozantinib franchise in the
Detailed Results from Phase 3 COSMIC-313 Pivotal Trial in Patients with Previously Untreated Advanced Renal Cell Carcinoma (RCC) Presented at the 2022
Pipeline Highlights
Presentation of Dose-Escalation Results from Phase 1b STELLAR-001 Trial Evaluating XL092 Monotherapy and in Combination with Atezolizumab in Patients with Advanced Solid Tumors at the 2022
Expanded Clinical Trial Collaboration and Supply Agreement with Bristol-Myers Squibb (BMS) to Include Fixed-Dose Combination of Nivolumab and Relatlimab in Combination with XL092 in Phase 1b STELLAR-002 Trial. In October,
Presentation of Initial Dose-Escalation Results from the First-in-Human Phase 1 JEWEL-101 Trial Evaluating XB002 in Patients with Advanced Solid Tumors at the 34th EORTC-NCI-AACR (ENA) Symposium. In October,
Corporate Updates
Exclusive License Agreement with Ryvu Therapeutics S.A. (Ryvu) to Develop Novel
Basis of Presentation
Conference Call and Webcast
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 888-338-9509 (domestic) or 412-902-4281 (international) and ask to be joined into the
A telephone replay will be available until
About
Founded in 1994,
Forward-Looking Statements
This press release contains forward-looking statements, including, without limitation, statements related to: Exelixis’ belief that new business development deals further its strategy to access clinical- or near-clinical-stage assets that have the potential to be first- or best-in-class medicines and may provide differentiated benefits to patients with cancer; Exelixis’ updated 2022 financial guidance; the potential for the triplet combination of XL092 and the fixed-dose combination of nivolumab and ipilimumab to be used in multiple expansion cohorts in the STELLAR-002 trial; Exelixis’ immediate and future financial and other obligations under its agreement with Ryvu; 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 and other
COTELLIC is a registered trademark of
MINNEBRO is a registered trademark of Daiichi Sankyo Company, Limited.
CONDENSED CONSOLIDATED STATEMENTS OF INCOME (in thousands, except per share amounts) (unaudited) |
|||||||||||||||
|
Three Months Ended |
|
Nine Months Ended |
||||||||||||
|
2022 |
|
2021 |
|
2022 |
|
2021 |
||||||||
Revenues: |
|
|
|
|
|
|
|
||||||||
Net product revenues |
$ |
366,482 |
|
|
$ |
263,117 |
|
|
$ |
1,023,824 |
|
$ |
774,577 |
|
|
License revenues |
|
34,384 |
|
|
|
49,694 |
|
|
|
123,977 |
|
|
|
116,862 |
|
Collaboration services revenues |
|
10,872 |
|
|
|
15,612 |
|
|
|
39,344 |
|
|
|
92,391 |
|
Total revenues |
|
411,738 |
|
|
|
328,423 |
|
|
|
1,187,145 |
|
|
|
983,830 |
|
Operating expenses: |
|
|
|
|
|
|
|
||||||||
Cost of goods sold |
|
15,305 |
|
|
|
11,874 |
|
|
|
41,989 |
|
|
|
39,956 |
|
Research and development |
|
198,837 |
|
|
|
163,370 |
|
|
|
554,989 |
|
|
|
471,448 |
|
Selling, general and administrative |
|
114,983 |
|
|
|
101,558 |
|
|
|
340,605 |
|
|
|
302,404 |
|
Total operating expenses |
|
329,125 |
|
|
|
276,802 |
|
|
|
937,583 |
|
|
|
813,808 |
|
Income from operations |
|
82,613 |
|
|
|
51,621 |
|
|
|
249,562 |
|
|
|
170,022 |
|
Interest income |
|
9,498 |
|
|
|
1,658 |
|
|
|
16,077 |
|
|
|
6,231 |
|
Other income (expense), net |
|
(69 |
) |
|
|
(19 |
) |
|
|
140 |
|
|
|
(120 |
) |
Income before income taxes |
|
92,042 |
|
|
|
53,260 |
|
|
|
265,779 |
|
|
|
176,133 |
|
Provision for income taxes |
|
18,832 |
|
|
|
15,056 |
|
|
|
53,324 |
|
|
|
40,236 |
|
Net income |
$ |
73,210 |
|
|
$ |
38,204 |
|
|
$ |
212,455 |
|
|
$ |
135,897 |
|
Net income per share: |
|
|
|
|
|
|
|
||||||||
Basic |
$ |
0.23 |
|
|
$ |
0.12 |
|
|
$ |
0.66 |
|
|
$ |
0.43 |
|
Diluted |
$ |
0.23 |
|
|
$ |
0.12 |
|
|
$ |
0.65 |
|
|
$ |
0.42 |
|
Weighted-average common shares outstanding: |
|
|
|
|
|
|
|
||||||||
Basic |
|
322,148 |
|
|
|
315,380 |
|
|
|
320,949 |
|
|
|
313,990 |
|
Diluted |
|
325,066 |
|
|
|
322,022 |
|
|
|
324,420 |
|
|
|
322,084 |
|
RECONCILIATION OF GAAP NET INCOME TO NON-GAAP NET INCOME (in thousands, except per share amounts) (unaudited) |
|||||||||||||||
|
Three Months Ended |
|
Nine Months Ended |
||||||||||||
|
2022 |
|
2021 |
|
2022 |
|
2021 |
||||||||
GAAP net income |
$ |
73,210 |
|
|
$ |
38,204 |
|
|
$ |
212,455 |
|
|
$ |
135,897 |
|
Adjustments: |
|
|
|
|
|
|
|
||||||||
Stock-based compensation – research and development expenses (1) |
|
16,438 |
|
|
|
11,487 |
|
|
|
34,886 |
|
|
|
37,550 |
|
Stock-based compensation – selling, general and administrative expenses (1) |
|
20,899 |
|
|
|
22,479 |
|
|
|
46,832 |
|
|
|
59,104 |
|
Income tax effect of the above adjustments |
|
(8,506 |
) |
|
|
(7,631 |
) |
|
|
(18,514 |
) |
|
|
(21,655 |
) |
Non-GAAP net income |
$ |
102,041 |
|
|
$ |
64,539 |
|
|
$ |
275,659 |
|
|
$ |
210,896 |
|
GAAP net income per share: |
|
|
|
|
|
|
|
||||||||
Basic |
$ |
0.23 |
|
|
$ |
0.12 |
|
|
$ |
0.66 |
|
|
$ |
0.43 |
|
Diluted |
$ |
0.23 |
|
|
$ |
0.12 |
|
|
$ |
0.65 |
|
|
$ |
0.42 |
|
Non-GAAP net income per share: |
|
|
|
|
|
|
|
||||||||
Basic |
$ |
0.32 |
|
|
$ |
0.20 |
|
|
$ |
0.86 |
|
|
$ |
0.67 |
|
Diluted |
$ |
0.31 |
|
|
$ |
0.20 |
|
|
$ |
0.85 |
|
|
$ |
0.65 |
|
Weighted-average common shares outstanding: |
|
|
|
|
|
|
|
||||||||
Basic |
|
322,148 |
|
|
|
315,380 |
|
|
|
320,949 |
|
|
|
313,990 |
|
Diluted |
|
325,066 |
|
|
|
322,022 |
|
|
|
324,420 |
|
|
|
322,084 |
|
(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/20221101005381/en/
Chief Financial Officer
650-837-7240
csenner@exelixis.com
EVP, Public Affairs & Investor Relations
650-837-8194
shubbard@exelixis.com
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