Exelixis Announces First Quarter 2024 Financial Results and Provides Corporate Update
Exelixis, Inc. (Nasdaq: EXEL) reported Q1 2024 financial results of $425M in total revenues, $379M from Cabozantinib Franchise U.S. Net Product Revenues. Restructuring expenses of $32.8M were recorded. GAAP Diluted EPS was $0.12, Non-GAAP Diluted EPS was $0.17. Exelixis focused on advancing pivotal trials, pipeline development, and label expansion for cabozantinib. The company maintained financial guidance for 2024. Positive clinical trial results were highlighted, and strategic priorities for 2024 were outlined. Exelixis also announced share repurchase program updates and key board member appointments.
Positive financial results with total revenues of $425M in Q1 2024.
Successful progress in advancing pivotal trials and pipeline development with potential growth in revenue from cabozantinib.
Positive clinical trial results for cabozantinib in combination with atezolizumab and CABOMETYX in RCC.
Maintaining financial guidance for 2024 demonstrates stability and growth prospects.
Strategic priorities for 2024 including restructuring, regulatory filings, and advancing clinical programs show a clear focus on innovation.
Restructuring expenses of $32.8M may impact short-term financials.
Decrease in average net selling price offsetting the increase in sales volume could affect profitability.
Lower GAAP net income compared to the same period in 2023 may raise concerns among investors.
Insights
- Total Revenues of
- Restructuring Expenses of
- GAAP Diluted EPS of
- Conference Call and Webcast Today at 5:00 PM Eastern Time -
“In the first quarter of 2024, Exelixis made important progress to advance a diverse, multi-product portfolio of small molecules and biotherapeutics with the potential to improve standards of care for patients with cancer,” said Michael M. Morrissey, Ph.D., President and Chief Executive Officer, Exelixis. “The team continued to execute across our three ongoing pivotal trials for zanzalintinib, as well as the phase 1 studies of our tissue-factor targeting ADC, XB002, and our small molecule USP1 inhibitor, XL309. We expect to provide updates from these programs as clinical data mature. In addition, we are on track for up to three Investigational New Drug filings this year, pending continued supportive preclinical data.”
Dr. Morrissey continued: “We also continued to pursue our label expansion plans for cabozantinib to drive future potential revenue growth of our flagship franchise and will provide additional updates on our regulatory strategies for both neuroendocrine tumors and metastatic castration-resistant prostate cancer, when appropriate. We believe the recent restructuring of our business, announced in January, further enhances our integrated research, development and commercial capabilities to deliver an innovative pipeline of cancer therapies for patients, while continuing to return capital back to our shareholders through our 2024 share repurchase program. As we drive the commercial and pipeline components of our business forward, we remain steadfast in our defense of cabozantinib’s intellectual property and anticipate a ruling on the second bench trial for our ongoing litigation with MSN Pharmaceuticals in the spring timeframe of this year.”
First Quarter 2024 Financial Results
Total revenues for the quarter ended March 31, 2024 were
Total revenues for the quarter ended March 31, 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 March 31, 2024 were
Selling, general and administrative expenses for the quarter ended March 31, 2024 were
Restructuring expenses for the quarter ended March 31, 2024 were
Provision for income taxes for the quarter ended March 31, 2024 was
GAAP net income for the quarter ended March 31, 2024 was
Non-GAAP net income for the quarter ended March 31, 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 maintaining the previously provided financial guidance for fiscal year 2024 (1):
Total revenues |
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Net product revenues (2) |
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Cost of goods sold |
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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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(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
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 American Society of Clinical Oncology 2024 Genitourinary Cancers Symposium (ASCO GU). In January, positive results from the primary progression-free survival (PFS) analysis in the global phase 3 CONTACT-02 pivotal trial were presented during an oral abstract session at ASCO GU. The results demonstrated a statistically significant improvement in PFS, as assessed by a blinded independent radiology committee (BIRC), for cabozantinib in combination with atezolizumab in the first 400 randomized patients in the intent-to-treat (PFS ITT) population and per protocol. A PFS benefit was observed across all subgroups of high-risk populations who have a poor prognosis and a high unmet need for additional treatment options, notably in patients with liver metastases or those who had received prior docetaxel chemotherapy. A statistically significant improvement in PFS was also observed by BIRC both in the ITT population (n=507) and according to Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria. An interim analysis for overall survival (OS), conducted at the time of the primary PFS analysis, demonstrated a trend favoring the combination of cabozantinib and atezolizumab. The study continues toward the next analysis of OS, which is anticipated in 2024. CONTACT-02 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 on one prior NHT. The safety profile of the combination regimen was consistent with the known profiles of each single agent, and no new safety findings were identified.
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 January, four-year follow-up results from the CheckMate -9ER trial were featured in an oral presentation at ASCO GU. Results continued to show superior PFS and objective response rates in patients treated with the combination of CABOMETYX and nivolumab over sunitinib, the comparator studied in the trial, regardless of risk classification. Superior OS was also observed in patients treated with the combination. The presentation included data showing health-related quality-of-life benefits with the combination as compared to sunitinib. No new safety concerns were identified in the follow-up analysis.
Cabozantinib and Zanzalintinib Data Presentations at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. Cabozantinib and zanzalintinib will be the subject of 10 presentations at this year’s ASCO Annual Meeting, which is being held from May 31 through June 4 in
Corporate Highlights
Announcement of Key Priorities and Anticipated Milestones for 2024. In January, Exelixis announced its key priorities and anticipated milestones for 2024, including: implementation of a corporate restructuring to prioritize the advancement of the company’s deep pipeline of clinical and near-clinical programs; potential
Share Repurchase Program. As of March 31, 2024, Exelixis has repurchased
Appointments of Two New Board Members with Extensive Drug Development and Corporate Governance Expertise. In January, Exelixis announced the appointments of Mary C. Beckerle, Ph.D., and S. Gail Eckhardt, M.D., to the Exelixis Board of Directors, effective January 5, 2024. Dr. Beckerle is Chief Executive Officer of the Huntsman Cancer Institute and Associate Vice President for Cancer Affairs and Distinguished Professor of Biology and Oncological Sciences at the University of
European Patent Office (EPO) Rules in Favor of Exelixis on Formulation Patent Covering Cabozantinib Tablets. In January, Exelixis successfully defended European Patent number EP2593090 (c-MET Modulator Pharmaceutical Compositions) against three opponents, STADA Arzneimittel AG, Teva Pharmaceutical Industries Ltd. and Generics (
Basis of Presentation
Exelixis has adopted a 52- or 53-week fiscal year that generally ends on the Friday closest to December 31st. For convenience, references in this press release as of and for the fiscal period ended March 29, 2024 is indicated as being as of and for the period ended March 31, 2024.
Conference Call and Webcast
Exelixis management will discuss the company’s financial results for the first 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, April 30, 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: the potential for Exelixis’ portfolio of small molecules and biotherapeutics to improve standards of care for patients with cancer; Exelixis’ expectation to submit Investigational New Drug filings for up to three development candidates in 2024, pending continued supportive preclinical data, and to provide updates for the zanzalintinib, XB002 and XL309 development programs as clinical data mature; Exelixis’ plans to advance its regulatory strategies for cabozantinib label expansions into NET and mCRPC indications, which could drive future potential revenue growth of the franchise, and to provide additional updates when appropriate; Exelixis’ belief that its restructuring will further enhance the company’s integrated research, development and commercial capabilities to deliver an innovative pipeline of cancer therapies for patients; Exelixis’ anticipation of a ruling in the second bench trial for its ongoing litigation with MSN Pharmaceuticals in the spring timeframe of 2024; Exelixis’ 2024 financial guidance; Exelixis’ anticipated timing of 2024 for the next analysis of OS from CONTACT-02; Exelixis’ plans to present cabozantinib and zanzalintinib data at the 2024 ASCO Annual Meeting, including a biomarker analysis from the clear cell RCC cohort of the phase 1b/2 STELLAR-001 study of zanzalintinib in advanced solid tumors; Exelixis’ key priorities and anticipated milestones for 2024; Exelixis’ plans to repurchase up to an additional
Exelixis, the Exelixis logo, CABOMETYX and COMETRIQ are registered trademarks of Exelixis, Inc.
OPDIVO® is a registered trademark of Bristol-Myers Squibb Company.
EXELIXIS, INC. CONDENSED CONSOLIDATED STATEMENTS OF INCOME (in thousands, except per share amounts) (unaudited) |
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Three Months Ended March 31, |
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2024 |
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2023 |
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Revenues: |
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Net product revenues |
$ |
378,523 |
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$ |
363,400 |
|
License revenues |
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44,676 |
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38,292 |
|
Collaboration services revenues |
|
2,027 |
|
|
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7,096 |
|
Total revenues |
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425,226 |
|
|
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408,788 |
|
Operating expenses: |
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|
|
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Cost of goods sold |
|
21,256 |
|
|
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14,315 |
|
Research and development |
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227,689 |
|
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234,246 |
|
Selling, general and administrative |
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113,984 |
|
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|
131,397 |
|
Restructuring |
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32,835 |
|
|
|
— |
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Total operating expenses |
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395,764 |
|
|
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379,958 |
|
Income from operations |
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29,462 |
|
|
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28,830 |
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Interest income |
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19,894 |
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19,502 |
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Other expense, net |
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(89 |
) |
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(54 |
) |
Income before income taxes |
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49,267 |
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48,278 |
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Provision for income taxes |
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11,950 |
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8,250 |
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Net income |
$ |
37,317 |
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$ |
40,028 |
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Net income per share: |
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Basic |
$ |
0.12 |
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$ |
0.12 |
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Diluted |
$ |
0.12 |
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$ |
0.12 |
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Weighted-average common shares outstanding: |
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Basic |
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300,757 |
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324,420 |
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Diluted |
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305,530 |
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326,279 |
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EXELIXIS, INC. RECONCILIATION OF GAAP NET INCOME TO NON-GAAP NET INCOME (in thousands, except per share amounts) (unaudited) |
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Three Months Ended March 31, |
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2024 |
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2023 |
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GAAP net income |
$ |
37,317 |
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$ |
40,028 |
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Adjustments: |
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Stock-based compensation - research and development expenses (1) |
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3,892 |
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3,252 |
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Stock-based compensation - selling, general and administrative expenses (1) |
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15,221 |
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13,409 |
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Income tax effect of the above adjustments |
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(4,448 |
) |
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(3,861 |
) |
Non-GAAP net income |
$ |
51,982 |
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$ |
52,828 |
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GAAP net income per share: |
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Basic |
$ |
0.12 |
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$ |
0.12 |
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Diluted |
$ |
0.12 |
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$ |
0.12 |
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Non-GAAP net income per share: |
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Basic |
$ |
0.17 |
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$ |
0.16 |
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Diluted |
$ |
0.17 |
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$ |
0.16 |
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Weighted-average common shares outstanding: |
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|
|
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Basic |
|
300,757 |
|
|
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324,420 |
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Diluted |
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305,530 |
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|
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326,279 |
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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. |
View source version on businesswire.com: https://www.businesswire.com/news/home/20240430821563/en/
Chris Senner
Chief Financial Officer
Exelixis, Inc.
650-837-7240
csenner@exelixis.com
Varant Shirvanian
Director, Investor Relations
Exelixis, Inc.
650-837-7917
vshirvanian@exelixis.com
Source: Exelixis, Inc.
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