Press Release
Press Release
Exelixis Announces Third Quarter 2024 Financial Results and Provides Corporate Update
- Total Revenues of
- GAAP Diluted EPS of
- Increasing Total Revenues and Net Product Revenues Guidance -
- Favorable Ruling on Cabozantinib Patent Litigation Received from
- Collaboration with Merck Expands Zanzalintinib Development Program -
- Conference Call and Webcast Today at
“The favorable ruling on our cabozantinib intellectual property estate and recently announced zanzalintinib development collaboration with Merck have generated important momentum to drive future growth across all components of our business,” said
Third Quarter 2024 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
Impairment of long-lived assets 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.
2024 Financial Guidance
|
Current Guidance
|
Previous Guidance
|
Total revenues |
|
|
Net product revenues(2) |
|
|
Cost of goods sold |
~4.5% of net product revenues |
4% - 5% of net product revenues |
Research and development expenses |
|
|
Selling, general and administrative expenses(5) |
|
|
Effective tax rate |
21% - 22% |
20% - 22% |
____________________ |
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(1) |
2024 financial guidance excludes expenses related to the restructuring plan announced in |
|
(2) |
Exelixis’ 2024 net product revenues guidance range includes the impact of a |
|
(3) |
Includes |
|
(4) |
Includes |
|
(5) |
Includes |
Corporate Highlights
Favorable Ruling in
New Clinical Development Collaboration with Merck to Evaluate Zanzalintinib in Combination with KEYTRUDA® (pembrolizumab) in Head and Neck Cancer and with WELIREG® (belzutifan) in Renal Cell Carcinoma (RCC). In October,
Stock Repurchase Program. In August,
Cabozantinib Highlights
Cabozantinib Franchise Net Product Revenues and Royalties. Net product revenues generated by the cabozantinib franchise in the
Exelixis’ Partner Ipsen Opted into Phase 3 CABINET Pivotal Trial in Advanced Neuroendocrine Tumors (NET) and Submitted an Extension of Indication Marketing Authorization to the
FDA Accepted Supplemental New Drug Application (sNDA) for Cabozantinib for Patients with Advanced NET. In August,
Final Results from Phase 3 CABINET Pivotal Trial Evaluating Cabozantinib in Advanced NET Presented at the 2024
Final Overall Survival (OS) Results from Phase 3 CONTACT-02 Pivotal Trial Evaluating Cabozantinib in Combination with Atezolizumab in Metastatic Castration-Resistant Prostate Cancer (mCRPC) Presented at the 2024
Pipeline Highlights
Enrollment Completion for Zanzalintinib Phase 3 STELLAR-303 Study in Metastatic Colorectal Cancer (CRC) and Announcement of STELLAR-311 Pivotal Trial Evaluating Zanzalintinib in NET. In August,
Initiation of Phase 1 Clinical Trial Evaluating XB010 in Patients with Advanced Solid Tumors. In August,
Initiation of Phase 1 Clinical Trial Evaluating XL495 in Patients with Advanced Solid Tumors. Today,
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. 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’ belief that the favorable ruling on its cabozantinib intellectual property estate and zanzalintinib development collaboration with Merck have generated important momentum to drive future growth across all components of the company’s business; Exelixis’ plans for cabozantinib label expansions in NET and prostate cancer; the potential for Exelixis’ zanzalintinib development program (including new planned pivotal trials), along with the rest of the company’s emerging pipeline, to improve standards of care for patients with cancer; Exelixis’ updated 2024 financial guidance; the timing of any regulatory approval and commercial launch in the
KETRUDA® and WELIREG® are registered trademarks of
a subsidiary of Merck & Co., Inc.,
CONDENSED CONSOLIDATED STATEMENTS OF INCOME (in thousands, except per share amounts) (unaudited) |
||||||||||||||
|
Three Months Ended |
|
Nine Months Ended |
|||||||||||
|
2024 |
|
2023 |
|
2024 |
|
2023 |
|||||||
Revenues: |
|
|
|
|
|
|
|
|||||||
Net product revenues |
$ |
478,059 |
|
|
$ |
426,497 |
|
|
$ |
1,294,163 |
|
|
$ |
1,199,543 |
License revenues |
|
60,239 |
|
|
|
42,367 |
|
|
|
299,901 |
|
|
|
133,406 |
Collaboration services revenues |
|
1,244 |
|
|
|
3,056 |
|
|
|
7,882 |
|
|
|
17,607 |
Total revenues |
|
539,542 |
|
|
|
471,920 |
|
|
|
1,601,946 |
|
|
|
1,350,556 |
Operating expenses: |
|
|
|
|
|
|
|
|||||||
Cost of goods sold |
|
17,328 |
|
|
|
18,774 |
|
|
|
56,251 |
|
|
|
50,794 |
Research and development |
|
222,570 |
|
|
|
332,585 |
|
|
|
661,406 |
|
|
|
799,401 |
Selling, general and administrative |
|
111,801 |
|
|
|
138,144 |
|
|
|
357,800 |
|
|
|
411,264 |
Impairment of long-lived assets |
|
51,672 |
|
|
|
— |
|
|
|
51,672 |
|
|
|
— |
Restructuring |
|
96 |
|
|
|
— |
|
|
|
33,406 |
|
|
|
— |
Total operating expenses |
|
403,467 |
|
|
|
489,503 |
|
|
|
1,160,535 |
|
|
|
1,261,459 |
Income (loss) from operations |
|
136,075 |
|
|
|
(17,583 |
) |
|
|
441,411 |
|
|
|
89,097 |
Interest income |
|
18,709 |
|
|
|
23,112 |
|
|
|
55,861 |
|
|
|
65,155 |
Other income (expense), net |
|
(29 |
) |
|
|
289 |
|
|
|
(405 |
) |
|
|
230 |
Income before income taxes |
|
154,755 |
|
|
|
5,818 |
|
|
|
496,867 |
|
|
|
154,482 |
Provision for income taxes |
|
36,782 |
|
|
|
4,777 |
|
|
|
115,461 |
|
|
|
32,235 |
Net income |
$ |
117,973 |
|
|
$ |
1,041 |
|
|
$ |
381,406 |
|
|
$ |
122,247 |
Net income per share: |
|
|
|
|
|
|
|
|||||||
Basic |
$ |
0.41 |
|
|
$ |
0.00 |
|
|
$ |
1.31 |
|
|
$ |
0.38 |
Diluted |
$ |
0.40 |
|
|
$ |
0.00 |
|
|
$ |
1.28 |
|
|
$ |
0.38 |
Weighted-average common shares outstanding: |
|
|
|
|
|
|
|
|||||||
Basic |
|
285,622 |
|
|
|
315,496 |
|
|
|
291,865 |
|
|
|
321,373 |
Diluted |
|
291,478 |
|
|
|
319,247 |
|
|
|
296,994 |
|
|
|
324,277 |
RECONCILIATION OF GAAP NET INCOME TO NON-GAAP NET INCOME (in thousands, except per share amounts) (unaudited) |
|||||||||||||||
|
Three Months Ended |
|
Nine Months Ended |
||||||||||||
|
2024 |
|
2023 |
|
2024 |
|
2023 |
||||||||
GAAP net income |
$ |
117,973 |
|
|
$ |
1,041 |
|
|
$ |
381,406 |
|
|
$ |
122,247 |
|
Adjustments: |
|
|
|
|
|
|
|
||||||||
Stock-based compensation - research and development expenses(1) |
|
8,764 |
|
|
|
12,438 |
|
|
|
21,834 |
|
|
|
25,279 |
|
Stock-based compensation - selling, general and administrative expenses(1) |
|
14,259 |
|
|
|
28,040 |
|
|
|
45,656 |
|
|
|
56,760 |
|
Income tax effect of the above adjustments |
|
(5,335 |
) |
|
|
(9,420 |
) |
|
|
(15,624 |
) |
|
|
(19,062 |
) |
Non-GAAP net income |
$ |
135,661 |
|
|
$ |
32,099 |
|
|
$ |
433,272 |
|
|
$ |
185,224 |
|
GAAP net income per share: |
|
|
|
|
|
|
|
||||||||
Basic |
$ |
0.41 |
|
|
$ |
0.00 |
|
|
$ |
1.31 |
|
|
$ |
0.38 |
|
Diluted |
$ |
0.40 |
|
|
$ |
0.00 |
|
|
$ |
1.28 |
|
|
$ |
0.38 |
|
Non-GAAP net income per share: |
|
|
|
|
|
|
|
||||||||
Basic |
$ |
0.47 |
|
|
$ |
0.10 |
|
|
$ |
1.48 |
|
|
$ |
0.58 |
|
Diluted |
$ |
0.47 |
|
|
$ |
0.10 |
|
|
$ |
1.46 |
|
|
$ |
0.57 |
|
Weighted-average common shares outstanding: |
|
|
|
|
|
|
|
||||||||
Basic |
|
285,622 |
|
|
|
315,496 |
|
|
|
291,865 |
|
|
|
321,373 |
|
Diluted |
|
291,478 |
|
|
|
319,247 |
|
|
|
296,994 |
|
|
|
324,277 |
|
____________________ |
||
(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/20241029473805/en/
Chief Financial Officer
650-837-7240
csenner@exelixis.com
Director, Investor Relations
650-837-7917
vshirvanian@exelixis.com
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