Press Release
Press Release
Exelixis Announces Third Quarter 2023 Financial Results and Provides Corporate Update
- Total Revenues of
- Conference Call and Webcast Today at
“The third quarter of 2023 was another strong one for the CABOMETYX® commercial franchise, which continues to fuel the buildout of our differentiated pipeline of small molecules and biotherapeutics,” said
Third Quarter 2023 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
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.
2023 Financial Guidance
Total revenues |
|
|
Net product revenues |
|
|
Cost of goods sold |
|
4.0% - 5.0% 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
Positive Results from Phase 3 CONTACT-02 Pivotal Trial Evaluating Cabozantinib in Combination with Atezolizumab in Metastatic Castration-Resistant Prostate Cancer (mCRPC). In August,
Detailed Results from Phase 3 CABINET Pivotal Trial Evaluating Cabozantinib in Advanced Pancreatic and Extra-Pancreatic Neuroendocrine Tumors Presented at the 2023
COSMIC-313 Second Interim Analysis of OS Secondary Endpoint. During the third quarter, a second prespecified interim analysis for the OS secondary endpoint of the phase 3 COSMIC-313 pivotal trial was completed. The data did not meet the threshold for statistical significance. Therefore, the trial will continue to the next planned analysis of OS, anticipated in 2024. The COSMIC-313 study is evaluating the triplet combination of cabozantinib, nivolumab and ipilimumab versus the combination of nivolumab and ipilimumab in previously untreated advanced intermediate- or poor-risk renal cell carcinoma. In
Corporate Highlights
Settlement of CABOMETYX Patent Litigation with
Appointment of
Share Repurchase Program. As of
Basis of Presentation
Conference Call and Webcast
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
Forward-Looking Statements
This press release contains forward-looking statements, including, without limitation, statements related to: Exelixis’ plans to present data from the clear cell renal cell carcinoma cohort of STELLAR-001 at the 2023 International Kidney Cancer Symposium in
CONDENSED CONSOLIDATED STATEMENTS OF INCOME (in thousands, except per share amounts) (unaudited) |
|||||||||||||
|
Three Months Ended |
|
Nine Months Ended |
||||||||||
|
2023 |
|
2022 |
|
2023 |
|
2022 |
||||||
Revenues: |
|
|
|
|
|
|
|
||||||
Net product revenues |
$ |
426,497 |
|
|
$ |
366,482 |
|
|
$ |
1,199,543 |
|
$ |
1,023,824 |
License revenues |
|
42,367 |
|
|
|
34,384 |
|
|
|
133,406 |
|
|
123,977 |
Collaboration services revenues |
|
3,056 |
|
|
|
10,872 |
|
|
|
17,607 |
|
|
39,344 |
Total revenues |
|
471,920 |
|
|
|
411,738 |
|
|
|
1,350,556 |
|
|
1,187,145 |
Operating expenses: |
|
|
|
|
|
|
|
||||||
Cost of goods sold |
|
18,774 |
|
|
|
15,305 |
|
|
|
50,794 |
|
|
41,989 |
Research and development |
|
332,585 |
|
|
|
198,837 |
|
|
|
799,401 |
|
|
554,989 |
Selling, general and administrative |
|
138,144 |
|
|
|
114,983 |
|
|
|
411,264 |
|
|
340,605 |
Total operating expenses |
|
489,503 |
|
|
|
329,125 |
|
|
|
1,261,459 |
|
|
937,583 |
Income (loss) from operations |
|
(17,583 |
) |
|
|
82,613 |
|
|
|
89,097 |
|
|
249,562 |
Interest income |
|
23,112 |
|
|
|
9,498 |
|
|
|
65,155 |
|
|
16,077 |
Other income (expense), net |
|
289 |
|
|
|
(69 |
) |
|
|
230 |
|
|
140 |
Income before income taxes |
|
5,818 |
|
|
|
92,042 |
|
|
|
154,482 |
|
|
265,779 |
Provision for income taxes |
|
4,777 |
|
|
|
18,832 |
|
|
|
32,235 |
|
|
53,324 |
Net income |
$ |
1,041 |
|
|
$ |
73,210 |
|
|
$ |
122,247 |
|
$ |
212,455 |
Net income per share: |
|
|
|
|
|
|
|
||||||
Basic |
$ |
0.00 |
|
|
$ |
0.23 |
|
|
$ |
0.38 |
|
$ |
0.66 |
Diluted |
$ |
0.00 |
|
|
$ |
0.23 |
|
|
$ |
0.38 |
|
$ |
0.65 |
Weighted-average common shares outstanding: |
|
|
|
|
|
|
|
||||||
Basic |
|
315,496 |
|
|
|
322,148 |
|
|
|
321,373 |
|
|
320,949 |
Diluted |
|
319,247 |
|
|
|
325,066 |
|
|
|
324,277 |
|
|
324,420 |
RECONCILIATION OF GAAP NET INCOME TO NON-GAAP NET INCOME (in thousands, except per share amounts) (unaudited) |
|||||||||||||||
|
Three Months Ended |
|
Nine Months Ended |
||||||||||||
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
GAAP net income |
$ |
1,041 |
|
|
$ |
73,210 |
|
|
$ |
122,247 |
|
|
$ |
212,455 |
|
Adjustments: |
|
|
|
|
|
|
|
||||||||
Stock-based compensation - research and development expenses (1) |
|
12,438 |
|
|
|
16,438 |
|
|
|
25,279 |
|
|
|
34,886 |
|
Stock-based compensation - selling, general and administrative expenses (1) |
|
28,040 |
|
|
|
20,899 |
|
|
|
56,760 |
|
|
|
46,832 |
|
Income tax effect of the above adjustments |
|
(9,420 |
) |
|
|
(8,506 |
) |
|
|
(19,062 |
) |
|
|
(18,514 |
) |
Non-GAAP net income |
$ |
32,099 |
|
|
$ |
102,041 |
|
|
$ |
185,224 |
|
|
$ |
275,659 |
|
GAAP net income per share: |
|
|
|
|
|
|
|
||||||||
Basic |
$ |
0.00 |
|
|
$ |
0.23 |
|
|
$ |
0.38 |
|
|
$ |
0.66 |
|
Diluted |
$ |
0.00 |
|
|
$ |
0.23 |
|
|
$ |
0.38 |
|
|
$ |
0.65 |
|
Non-GAAP net income per share: |
|
|
|
|
|
|
|
||||||||
Basic |
$ |
0.10 |
|
|
$ |
0.32 |
|
|
$ |
0.58 |
|
|
$ |
0.86 |
|
Diluted |
$ |
0.10 |
|
|
$ |
0.31 |
|
|
$ |
0.57 |
|
|
$ |
0.85 |
|
Weighted-average common shares outstanding: |
|
|
|
|
|
|
|
||||||||
Basic |
|
315,496 |
|
|
|
322,148 |
|
|
|
321,373 |
|
|
|
320,949 |
|
Diluted |
|
319,247 |
|
|
|
325,066 |
|
|
|
324,277 |
|
|
|
324,420 |
|
____________________ |
||
(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/20231101406976/en/
Chief Financial Officer
650-837-7240
csenner@exelixis.com
Susan Hubbard
EVP, Public Affairs & Investor Relations
650-837-8194
shubbard@exelixis.com
Source: