Exelixis Announces Fourth Quarter and Fiscal Year 2023 Financial Results and Provides Corporate Update
- Total Revenues of
- Cabozantinib Franchise Achieved
- GAAP Diluted EPS of
- Non-GAAP Diluted EPS of
- Conference Call and Webcast Today at
“Exelixis entered 2024 with significant momentum on the research, development, commercial and financial fronts,” said
Fourth Quarter and Fiscal Year 2023 Financial Results
Total revenues for the quarter and year ended
Total revenues for the quarter and year 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 and year ended
Provision for (benefit from) income taxes for the quarter and year ended
GAAP net income (loss) for the quarter ended
Non-GAAP net income (loss) 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
Total revenues |
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Net product revenues (2) |
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Cost of goods sold |
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4% - 5% of net product revenues |
Research and development expenses (3) |
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Selling, general and administrative expenses (4) |
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Effective tax rate |
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20% - 22% |
____________________ | ||
(1) |
2024 financial guidance excludes expenses related to the restructuring plan announced in |
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(2) |
Exelixis’ 2024 net product revenues guidance range includes the impact of a |
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(3) |
Includes |
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(4) |
Includes |
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Cabozantinib Highlights
Cabozantinib Franchise Net Product Revenues and Royalties. Net product revenues generated by the cabozantinib franchise in the
Detailed Results from Phase 3 CABINET Pivotal Trial Evaluating Cabozantinib in Advanced Pancreatic and Extra-Pancreatic Neuroendocrine Tumors (NET) Presented at the 2023
Detailed Results from Phase 3 CONTACT-02 Pivotal Trial Evaluating Cabozantinib in Combination with Atezolizumab in Metastatic Castration-Resistant Prostate Cancer (mCRPC) Presented at the
Four-Year Follow-up Results from Phase 3 CheckMate -9ER Trial Evaluating CABOMETYX in Combination with Nivolumab (OPDIVO®) in Previously Untreated Renal Cell Carcinoma (RCC) Presented at ASCO GU. In
Pipeline Highlights
Presentation of Encouraging Results from Expansion Cohort of Phase 1b/2 STELLAR-001 Trial Evaluating Zanzalintinib in Patients with Advanced Kidney Cancer at the International Kidney Cancer Symposium (IKCS) 2023. In
Initiation of STELLAR-305 Phase 2/3 Pivotal Trial Evaluating Zanzalintinib in Combination with Pembrolizumab in Patients with Previously Untreated Recurrent or Metastatic Head and Neck Cancer. In
Exelixis Provides Strategic Review of Biotherapeutics and Small Molecule Pipeline at its 2023 R&D Day: Science & Strategy. In
Corporate Highlights
Appointments of Two New Board Members with Extensive Drug Development and Corporate Governance Expertise. In
Share Repurchase Program. In
Announcement of Key Priorities and Anticipated Milestones for 2024. In
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’ 2024 plans to advance its regulatory strategies for cabozantinib label expansions into NET and mCRPC indications, both with the potential to drive revenue growth for the franchise for years to come, and Exelixis’ confidence that cabozantinib has the potential to become an important treatment option for clinicians treating patients with these forms of cancer; Exelixis’ anticipation of a ruling in the second bench trial for its ongoing litigation with
OPDIVO® is a registered trademark of Bristol-Myers Squibb Company.
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CONDENSED CONSOLIDATED STATEMENTS OF INCOME |
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(in thousands, except per share amounts) |
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(unaudited) |
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Three Months Ended
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Year Ended
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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 |
$ |
429,336 |
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|
$ |
377,419 |
|
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$ |
1,628,879 |
|
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$ |
1,401,243 |
|
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License revenues |
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45,229 |
|
|
|
38,079 |
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|
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178,635 |
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|
|
162,056 |
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Collaboration services revenues |
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5,087 |
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8,419 |
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22,694 |
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47,763 |
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Total revenues |
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479,652 |
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423,917 |
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1,830,208 |
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1,611,062 |
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Operating expenses: |
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Cost of goods sold |
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21,753 |
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15,920 |
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72,547 |
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57,909 |
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Research and development |
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244,670 |
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336,824 |
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1,044,071 |
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|
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891,813 |
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Selling, general and administrative |
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131,441 |
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119,251 |
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542,705 |
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459,856 |
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Total operating expenses |
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397,864 |
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471,995 |
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1,659,323 |
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|
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1,409,578 |
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Income (loss) from operations |
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81,788 |
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|
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(48,078 |
) |
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170,885 |
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201,484 |
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Interest income |
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21,388 |
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16,988 |
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86,543 |
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33,065 |
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Other income (expense), net |
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(137 |
) |
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(337 |
) |
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|
93 |
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|
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(197 |
) |
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Income (loss) before income taxes |
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103,039 |
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(31,427 |
) |
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257,521 |
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234,352 |
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Provision for (benefit from) income taxes |
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17,521 |
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(1,254 |
) |
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49,756 |
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52,070 |
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Net income (loss) |
$ |
85,518 |
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|
$ |
(30,173 |
) |
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$ |
207,765 |
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$ |
182,282 |
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Net income (loss) per share: |
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Basic |
$ |
0.28 |
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$ |
(0.09 |
) |
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$ |
0.65 |
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$ |
0.57 |
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Diluted |
$ |
0.27 |
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$ |
(0.09 |
) |
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$ |
0.65 |
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$ |
0.56 |
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Weighted-average common shares outstanding: |
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Basic |
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308,482 |
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323,256 |
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318,151 |
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321,526 |
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Diluted (1) |
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313,023 |
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323,256 |
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321,464 |
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324,556 |
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____________________ | ||
(1) |
The dilutive effect of shares related to employee stock plans are not included in the calculation of GAAP diluted loss per share in the fourth quarter of 2022 as the effect would be anti-dilutive. |
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RECONCILIATION OF GAAP NET INCOME TO NON-GAAP NET INCOME |
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(in thousands, except per share amounts) |
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(unaudited) |
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Three Months Ended
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Year Ended
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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 (loss) |
$ |
85,518 |
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$ |
(30,173 |
) |
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$ |
207,765 |
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$ |
182,282 |
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Adjustments: |
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Stock-based compensation - research and development expenses (1) |
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9,041 |
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10,464 |
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34,320 |
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45,350 |
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Stock-based compensation - selling, general and administrative expenses (1) |
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15,265 |
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15,392 |
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72,025 |
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62,224 |
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Income tax effect of the above adjustments |
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(5,629 |
) |
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(5,897 |
) |
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(24,691 |
) |
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(24,411 |
) |
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Non-GAAP net income (loss) |
$ |
104,195 |
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$ |
(10,214 |
) |
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$ |
289,419 |
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$ |
265,445 |
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GAAP net income (loss) per share: |
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Basic |
$ |
0.28 |
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$ |
(0.09 |
) |
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$ |
0.65 |
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$ |
0.57 |
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Diluted (2) |
$ |
0.27 |
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$ |
(0.09 |
) |
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$ |
0.65 |
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$ |
0.56 |
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Non-GAAP net income (loss) per share: |
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Basic |
$ |
0.34 |
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|
$ |
(0.03 |
) |
|
$ |
0.91 |
|
|
$ |
0.83 |
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Diluted |
$ |
0.33 |
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$ |
(0.03 |
) |
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$ |
0.90 |
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$ |
0.82 |
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Weighted-average common shares outstanding: |
|
|
|
|
|
|
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Basic |
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308,482 |
|
|
|
323,256 |
|
|
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318,151 |
|
|
|
321,526 |
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Diluted (2) |
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313,023 |
|
|
|
323,256 |
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|
|
321,464 |
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|
|
324,556 |
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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. |
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(2) |
The dilutive effect of shares related to employee stock plans are not included in the calculation of GAAP and Non-GAAP diluted loss per share in the fourth quarter of 2022 as the effect would be anti-dilutive. |
View source version on businesswire.com: https://www.businesswire.com/news/home/20240206885107/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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