Exelixis Announces Second Quarter 2024 Financial Results and Provides Corporate Update
- Total Revenues of
- GAAP Diluted EPS of
-
- Earned
- Completed
- Announced Additional Stock Repurchase Program for up to
- Conference Call and Webcast Today at 5:00 PM Eastern Time -
“Exelixis is well positioned for an impactful second half of 2024 as we continue to grow the cabozantinib franchise, execute on our regulatory and development objectives, and advance our next-generation pipeline,” said Michael M. Morrissey, Ph.D., President and CEO, Exelixis. “Cabozantinib’s second quarter commercial performance was strong both in the
Second Quarter 2024 Financial Results
Total revenues for the quarter ended June 30, 2024 were
Total revenues for the quarter ended June 30, 2024 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, 2024 were
Selling, general and administrative expenses for the quarter ended June 30, 2024 were
Provision for income taxes for the quarter ended June 30, 2024 was
GAAP net income for the quarter ended June 30, 2024 was
Non-GAAP net income for the quarter ended June 30, 2024 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.
2024 Financial Guidance
Exelixis is providing the following updated financial guidance for fiscal year 2024 (1):
Total revenues |
|
|
Net product revenues (2) |
|
|
Cost of goods sold |
|
|
Research and development expenses (3) |
|
|
Selling, general and administrative expenses (4) |
|
|
Effective tax rate |
|
|
____________________ (1) 2024 financial guidance excludes expenses related to the restructuring plan announced in January 2024.
(2) Exelixis’ 2024 net product revenues guidance range includes the impact of a
(3) Includes
(4) Includes |
Cabozantinib and Pipeline Highlights
Cabozantinib Franchise Net Product Revenues and Royalties. Net product revenues generated by the cabozantinib franchise in the
Achievement of Cabozantinib Sales-Based Milestone from Ipsen. Today, Exelixis announced it earned and recognized in license revenues a
FDA Accepts for Standard Review the sNDA for Cabozantinib for Patients with Advanced NET; Updated Results from Phase 3 CABINET Study to be Presented during an Oral Presentation at the European Society for Medical Oncology (ESMO) Congress 2024. Today, Exelixis announced that the FDA accepted its sNDA for cabozantinib for patients with previously treated advanced pancreatic NET (pNET), and for patients with previously treated advanced extra-pancreatic NET (epNET). The FDA assigned a standard review with a Prescription Drug User Fee Act (PDUFA) target action date of April 3, 2025. The FDA also granted orphan drug designation to cabozantinib for the treatment of pNET. The application was based on results from the phase 3 CABINET trial, which evaluated cabozantinib compared with placebo in patients with previously treated pNET and epNET. The CABINET study is sponsored by the National Cancer Institute (NCI), part of the National Institutes of Health, and led by the NCI-funded Alliance for Clinical Trials in Oncology. Updated results from CABINET, including final results on the primary efficacy endpoint of progression-free survival by Blinded Independent Central Review, will be presented during the ESMO Congress 2024 in September.
Exelixis Partner Ipsen Opts into Phase 3 CABINET Pivotal Trial in Advanced NET. In July, Ipsen announced it opted into the phase 3 CABINET pivotal trial, expanding the existing collaboration and license agreement with Exelixis and permitting Ipsen to seek potential marketing authorizations for CABOMETYX in advanced pNET and epNET from regulatory authorities outside of the
Phase 3 CONTACT-02 Metastatic Castration-Resistant Prostate Cancer (mCRPC) Study Update and Intention to Submit sNDA in 2024. Today, Exelixis announced that the final overall survival (OS) analysis for the phase 3 CONTACT-02 trial has been completed. This study is evaluating cabozantinib in combination with atezolizumab compared with a second novel hormonal therapy (NHT) in patients with mCRPC and measurable soft-tissue disease who have progressed after treatment with one prior NHT. As previously reported, the CONTACT-02 study met one of its two primary endpoints, demonstrating a statistically significant benefit in progression-free survival (PFS) (hazard ratio: 0.65;
Enrollment Completion for Zanzalintinib Phase 3 STELLAR-303 Study and Announcement of New Pivotal Trial for Zanzalintinib in Neuroendocrine Tumors. Today, Exelixis announced that enrollment has been completed in the STELLAR-303 phase 3 pivotal study. STELLAR-303 is evaluating zanzalintinib in combination with atezolizumab compared with regorafenib in patients with metastatic refractory colorectal cancer that is not microsatellite instability-high or mismatch repair-deficient. The primary endpoint in the study is OS in the patients without liver metastases. Exelixis anticipates preliminary results from the study to readout in 2025. Additionally, Exelixis intends to initiate a new phase 3 pivotal trial, STELLAR-311, evaluating zanzalintinib compared with everolimus as a first oral therapy in patients with pNET and epNET, in the first half of 2025.
Initiation of Phase 1 Clinical Trial Evaluating XB010 in Patients with Advanced Solid Tumors. Today, Exelixis announced the initiation of the dose-escalation stage of the first-in-human phase 1 clinical trial of XB010 in patients with locally advanced or metastatic solid tumors. XB010, an antibody-drug conjugate (ADC) consisting of a monomethyl auristatin E payload conjugated to a monoclonal antibody targeting the tumor antigen 5T4, is the first custom ADC generated through Exelixis’ biotherapeutics collaboration network. The dose-escalation stage of this phase 1, global, open-label study will evaluate XB010 as a single agent and in combination with pembrolizumab to inform the cohort-expansion stage. The expansion cohorts are designed to further assess the tolerability and activity of monotherapy and of the combination in specific indications.
Portfolio Prioritization Update. Today, Exelixis announced it will discontinue the development of XB002, the company’s tissue factor (TF)-targeting ADC, as part of its portfolio prioritization efforts. Based on available data, the compound is unlikely to improve upon tisotumab vedotin or other competitor TF-targeting ADCs currently in development. The company plans to disclose data from the phase 1 JEWEL-101 study, evaluating XB002 in advanced solid tumors, at a later date. Preclinical development of XB371, its ADC consisting of a topoisomerase payload conjugated to a TF-targeting monoclonal antibody, is ongoing. Exelixis plans to reallocate resources to new pivotal trials with zanzalintinib, advancing XL309 and its growing pipeline.
Corporate Highlights
Settlement of CABOMETYX Patent Litigation with Cipla Limited and Cipla
Completion of the
Announcement of Additional Stock Repurchase Program for up to
Basis of Presentation
Exelixis has adopted a 52- or 53-week fiscal year that generally ends on the Friday closest to December 31. For convenience, references in this press release as of and for the fiscal periods ended June 28, 2024 are indicated as being as of and for the periods ended June 30, 2024.
Conference Call and Webcast
Exelixis management will discuss the company’s financial results for the second quarter of 2024 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 6, 2024.
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 Exelixis
Exelixis is a globally ambitious oncology company innovating next-generation medicines and regimens at the forefront of cancer care. Powered by drug 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 X (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’ belief that it is well-positioned for an impactful second half of 2024; the regulatory review process with respect to Exelixis’ sNDA for cabozantinib in advanced NET, including the PDUFA target action date assigned by the FDA, and the potential to bring cabozantinib as a new treatment option for these patients with high unmet medical need; Exelixis’ plans to reallocate resources to new pivotal trials in zanzalintinib and to advancing phase 1 efforts for XL309 and XB010, as well as to the rest of the company’s growing pipeline; Exelixis’ updated 2024 financial guidance; the anticipated timing for receipt of a
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) |
|||||||||||||||
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
||||||||||||
|
|
2024 |
|
|
|
2023 |
|
|
|
2024 |
|
|
|
2023 |
|
Revenues: |
|
|
|
|
|
|
|
||||||||
Net product revenues |
$ |
437,581 |
|
|
$ |
409,646 |
|
|
$ |
816,104 |
|
|
$ |
773,046 |
|
License revenues |
|
194,986 |
|
|
|
52,747 |
|
|
|
239,662 |
|
|
|
91,039 |
|
Collaboration services revenues |
|
4,611 |
|
|
|
7,455 |
|
|
|
6,638 |
|
|
|
14,551 |
|
Total revenues |
|
637,178 |
|
|
|
469,848 |
|
|
|
1,062,404 |
|
|
|
878,636 |
|
Operating expenses: |
|
|
|
|
|
|
|
||||||||
Cost of goods sold |
|
17,667 |
|
|
|
17,705 |
|
|
|
38,923 |
|
|
|
32,020 |
|
Research and development |
|
211,147 |
|
|
|
232,570 |
|
|
|
438,836 |
|
|
|
466,816 |
|
Selling, general and administrative |
|
132,015 |
|
|
|
141,723 |
|
|
|
245,999 |
|
|
|
273,120 |
|
Restructuring |
|
475 |
|
|
|
— |
|
|
|
33,310 |
|
|
|
— |
|
Total operating expenses |
|
361,304 |
|
|
|
391,998 |
|
|
|
757,068 |
|
|
|
771,956 |
|
Income from operations |
|
275,874 |
|
|
|
77,850 |
|
|
|
305,336 |
|
|
|
106,680 |
|
Interest income |
|
17,258 |
|
|
|
22,541 |
|
|
|
37,152 |
|
|
|
42,043 |
|
Other expense, net |
|
(287 |
) |
|
|
(5 |
) |
|
|
(376 |
) |
|
|
(59 |
) |
Income before income taxes |
|
292,845 |
|
|
|
100,386 |
|
|
|
342,112 |
|
|
|
148,664 |
|
Provision for income taxes |
|
66,729 |
|
|
|
19,208 |
|
|
|
78,679 |
|
|
|
27,458 |
|
Net income |
$ |
226,116 |
|
|
$ |
81,178 |
|
|
$ |
263,433 |
|
|
$ |
121,206 |
|
Net income per share: |
|
|
|
|
|
|
|
||||||||
Basic |
$ |
0.78 |
|
|
$ |
0.25 |
|
|
$ |
0.89 |
|
|
$ |
0.37 |
|
Diluted |
$ |
0.77 |
|
|
$ |
0.25 |
|
|
$ |
0.88 |
|
|
$ |
0.37 |
|
Weighted-average common shares outstanding: |
|
|
|
|
|
|
|
||||||||
Basic |
|
289,216 |
|
|
|
324,205 |
|
|
|
294,986 |
|
|
|
324,312 |
|
Diluted |
|
293,974 |
|
|
|
327,305 |
|
|
|
299,752 |
|
|
|
326,792 |
|
EXELIXIS, INC. RECONCILIATION OF GAAP NET INCOME TO NON-GAAP NET INCOME (in thousands, except per share amounts) (unaudited) |
|||||||||||||||
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
||||||||||||
|
|
2024 |
|
|
|
2023 |
|
|
|
2024 |
|
|
|
2023 |
|
GAAP net income |
$ |
226,116 |
|
|
$ |
81,178 |
|
|
$ |
263,433 |
|
|
$ |
121,206 |
|
Adjustments: |
|
|
|
|
|
|
|
||||||||
Stock-based compensation - research and development expenses (1) |
|
9,178 |
|
|
|
9,589 |
|
|
|
13,070 |
|
|
|
12,841 |
|
Stock-based compensation - selling, general and administrative expenses (1) |
|
16,176 |
|
|
|
15,311 |
|
|
|
31,397 |
|
|
|
28,720 |
|
Income tax effect of the above adjustments |
|
(5,841 |
) |
|
|
(5,781 |
) |
|
|
(10,289 |
) |
|
|
(9,642 |
) |
Non-GAAP net income |
$ |
245,629 |
|
|
$ |
100,297 |
|
|
$ |
297,611 |
|
|
$ |
153,125 |
|
GAAP net income per share: |
|
|
|
|
|
|
|
||||||||
Basic |
$ |
0.78 |
|
|
$ |
0.25 |
|
|
$ |
0.89 |
|
|
$ |
0.37 |
|
Diluted |
$ |
0.77 |
|
|
$ |
0.25 |
|
|
$ |
0.88 |
|
|
$ |
0.37 |
|
Non-GAAP net income per share: |
|
|
|
|
|
|
|
||||||||
Basic |
$ |
0.85 |
|
|
$ |
0.31 |
|
|
$ |
1.01 |
|
|
$ |
0.47 |
|
Diluted |
$ |
0.84 |
|
|
$ |
0.31 |
|
|
$ |
0.99 |
|
|
$ |
0.47 |
|
Weighted-average common shares outstanding: |
|
|
|
|
|
|
|
||||||||
Basic |
|
289,216 |
|
|
|
324,205 |
|
|
|
294,986 |
|
|
|
324,312 |
|
Diluted |
|
293,974 |
|
|
|
327,305 |
|
|
|
299,752 |
|
|
|
326,792 |
|
____________________ (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/20240806336755/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.