Exelixis Announces Fourth Quarter and Fiscal Year 2023 Financial Results and Provides Corporate Update
- Total revenues of $480 million for the Fourth Quarter of 2023, $1,830 million for the Fiscal Year 2023.
- Cabozantinib Franchise Achieved $1,629 million in U.S. Net Product Revenues for the Fiscal Year 2023, including $429 million for the Fourth Quarter of 2023.
- GAAP Diluted EPS of $0.27 for the Fourth Quarter of 2023, $0.65 for the Fiscal Year 2023.
- Non-GAAP Diluted EPS of $0.33 for the Fourth Quarter of 2023, $0.90 for the Fiscal Year 2023.
- The company is focusing on advancing regulatory strategies for cabozantinib label expansions in neuroendocrine tumors and metastatic castration-resistant prostate cancer, with high unmet medical need.
- None.
Insights
The recent financial results reported by Exelixis, Inc. demonstrate a robust performance with a significant increase in total revenues year-over-year, reaching $1,830 million for the Fiscal Year 2023. This uptick is primarily attributed to the increased sales volume and average net selling price of the Cabozantinib franchise. The franchise's growth, especially in the U.S. market, is a positive indicator of the company's commercial strength and its ability to capitalize on its flagship products, CABOMETYX and COMETRIQ.
From a financial perspective, the reported GAAP and non-GAAP EPS indicate healthy profitability, with a notable improvement in GAAP net income. The non-GAAP measures, which exclude stock-based compensation, offer investors a clearer view of the company's operational efficiency. However, investors should be cautious as the increased R&D and SG&A expenses could signal rising costs that might affect future margins if not managed effectively.
Looking forward, the 2024 financial guidance provided by Exelixis reflects management's confidence in the company's revenue-generating capabilities. Yet, it is crucial for investors to monitor the execution of the company's strategic initiatives and the outcome of ongoing litigation, which could influence the stock's performance.
Exelixis' focus on expanding the label for Cabozantinib into additional cancer indications, such as neuroendocrine tumors and metastatic castration-resistant prostate cancer, is a strategic move that could significantly extend the drug's market reach. The positive data from the CABINET and CONTACT-02 studies suggest a strong potential for Cabozantinib to become a preferred treatment option, which is critical for sustaining long-term revenue growth.
It is essential to consider the competitive landscape in oncology, where continuous innovation is key. The company's pipeline development, especially the progress of zanzalintinib, XB002 and XL309, will be pivotal in maintaining a competitive edge. The restructuring announced in January aims to streamline operations and could potentially accelerate the clinical development process, but it also requires careful management to avoid disruptions.
The clinical trial results presented at various symposiums reinforce the drug's efficacy and safety profile, which is promising for regulatory approvals. However, the real-world effectiveness and market adoption post-approval will be the ultimate test of the drug's commercial success.
The pharmaceutical industry, particularly the oncology sector, is highly sensitive to clinical trial outcomes and regulatory approvals. Exelixis' strategic updates and clinical progress are likely to have a positive impact on investor sentiment. The company's ability to meet the high unmet medical need in specific cancer indications can lead to market dominance for its products and potentially drive the stock price.
Analyzing Exelixis' collaborations, such as with Ipsen Pharma SAS and Takeda Pharmaceutical Company Limited, is crucial as these partnerships contribute to the company's international revenues through royalties. The global reach and success of Cabozantinib will depend on the strength of these collaborations and the ability to navigate different regulatory landscapes.
Investors should also be aware of the industry's pricing dynamics, as Exelixis' U.S. wholesale acquisition cost increase could affect demand elasticity. The company's guidance for 2024 indicates a proactive approach to managing operational costs, which is essential for sustaining profitability amidst growing R&D investments.
- Total Revenues of
- Cabozantinib Franchise Achieved
- GAAP Diluted EPS of
- Non-GAAP Diluted EPS of
- Conference Call and Webcast Today at 5:00 PM Eastern Time -
“Exelixis entered 2024 with significant momentum on the research, development, commercial and financial fronts,” said Michael M. Morrissey, Ph.D., President and Chief Executive Officer, Exelixis. “This year, we plan to advance our regulatory strategies for cabozantinib label expansions in neuroendocrine tumors and metastatic castration-resistant prostate cancer, both indications with high unmet medical need and the potential to drive revenue growth for the franchise for years to come. Positive data from the CABINET and CONTACT-02 studies give us confidence that cabozantinib has the potential to become an important option for clinicians treating patients with these forms of cancer. As we pursue these additional growth opportunities, 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 this spring.”
Dr. Morrissey continued: “Our deep, differentiated and maturing pipeline is essential to our efforts to position Exelixis as a global biotech leader in oncology. Drawing on the cabozantinib experience and the integrated research, development and commercial capabilities highlighted at our recent R&D Day, we are working to build multiple franchises across the Exelixis portfolio. As we concentrate our R&D resources on our product development activities, we remain focused on accelerating zanzalintinib, XB002 and XL309 through clinical development, and filing Investigational New Drug applications for up to three development candidates in 2024. We believe the associated restructuring of our business, announced in January, will enable us to rapidly execute on our goals, maintain positive cash flow and deliver an innovative pipeline of biotherapeutics and small molecules for patients with cancer.”
Fourth Quarter and Fiscal Year 2023 Financial Results
Total revenues for the quarter and year ended December 31, 2023 were
Total revenues for the quarter and year ended December 31, 2023 included net product revenues of
Collaboration revenues, composed of license revenues and collaboration services revenues, were
Research and development expenses for the quarter ended December 31, 2023 were
Selling, general and administrative expenses for the quarter and year ended December 31, 2023 were
Provision for (benefit from) income taxes for the quarter and year ended December 31, 2023 was
GAAP net income (loss) for the quarter ended December 31, 2023 was
Non-GAAP net income (loss) for the quarter ended December 31, 2023 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. |
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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 European Society for Medical Oncology (ESMO) Congress. In October 2023, detailed results were presented from the phase 3 CABINET pivotal trial at the 2023 ESMO Congress. The CABINET trial evaluated cabozantinib versus placebo in two different cohorts of patients, those with pancreatic NET and those with extra-pancreatic NET. A statistically significant and clinically meaningful improvement in progression-free survival (PFS) was observed in those patients treated with cabozantinib in both cohorts. Adverse events were consistent with the known safety profile of cabozantinib. CABINET is sponsored by the National Cancer Institute and is led by The Alliance for Clinical Trials in Oncology (The Alliance). Previously, in August, Exelixis announced The Alliance’s independent Data and Safety Monitoring Board unanimously recommended to stop the trial early, unblind all patients and allow those on placebo to cross over to cabozantinib due to a dramatic improvement in efficacy. Exelixis is discussing these results with 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 2024, positive results from the primary 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 extra-pelvic 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. Exelixis will continue its discussions with the FDA on a potential regulatory path forward for the combination of cabozantinib and atezolizumab in mCRPC.
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 2024, 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 (ORR) 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.
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 November 2023, Exelixis presented initial results from an expansion cohort of STELLAR-001 evaluating single-agent zanzalintinib in patients with previously treated clear cell renal cell carcinoma (ccRCC) at IKCS 2023. STELLAR-001 is a phase 1b/2 trial evaluating zanzalintinib alone and in combination with atezolizumab in patients with locally advanced or metastatic solid tumors. In the ccRCC cohort of 32 patients, the findings demonstrated strong response rates and anti-tumor activity across the entire cohort, including in patients who had previously been treated with cabozantinib.
Exelixis and Arcus Biosciences, Inc. Enter Clinical Trial Collaboration to Evaluate Zanzalintinib in Combination with AB521 in Patients with Advanced RCC. In December 2023, Exelixis and Arcus Biosciences announced that the companies entered into a clinical trial collaboration for STELLAR-009, a phase 1b/2 trial evaluating zanzalintinib in combination with AB521, an inhibitor of the transcription factor HIF-2⍺, in patients with advanced solid tumors, including ccRCC. The trial is divided into dose-escalation and expansion phases, and patient enrollment into dose-escalation cohorts is ongoing. Exelixis is sponsoring STELLAR-009, and Arcus is co-funding the study and providing AB521 for use in the trial.
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 December 2023, Exelixis announced the initiation of STELLAR-305, a global, multicenter, randomized, double-blinded phase 2/3 trial evaluating zanzalintinib in combination with pembrolizumab versus pembrolizumab alone in patients with previously untreated PD-L1-positive recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN). The primary endpoints of the study are BIRC-assessed PFS and OS. Secondary endpoints include investigator-assessed PFS and ORR and duration of response as assessed by both BIRC and the investigator.
Exelixis Provides Strategic Review of Biotherapeutics and Small Molecule Pipeline at its 2023 R&D Day: Science & Strategy. In December 2023, Exelixis held its 2023 R&D Day: Science & Strategy event in
Corporate Highlights
Appointments of Two New Board Members with Extensive Drug Development and Corporate Governance Expertise. In January 2024, Exelixis announced the appointments of Mary C. Beckerle, Ph.D., and 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 Distinguished Professor of Biological and Oncological Sciences at the University of
Share Repurchase Program. In January 2024, the Exelixis Board of Directors authorized the repurchase of up to an additional
Announcement of Key Priorities and Anticipated Milestones for 2024. In January 2024, 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
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 periods ended December 29, 2023 and December 30, 2022 are indicated as being as of and for the periods ended December 31, 2023 and 2022, respectively.
Conference Call and Webcast
Exelixis management will discuss the company’s financial results for the fourth quarter and fiscal year of 2023 and provide a general business update during a conference call beginning at 5:00 p.m. ET / 2:00 p.m. PT today, Tuesday, February 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’ 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 MSN Pharmaceuticals in the first half of 2024; Exelixis’ plans to accelerate zanzalintinib, XB002 and XL309 through clinical development and to file Investigational New Drug applications for up to three development candidates in 2024 as part of its efforts to become a global biotech leader in oncology, as well as Exelixis’ belief that its associated restructuring will enable the company to rapidly execute on its goals, maintain positive cash flow and deliver an innovative pipeline of biotherapeutics and small molecules for patients with cancer; Exelixis’ 2024 financial guidance; Exelixis’ plans with respect to potential regulatory submissions for cabozantinib in advanced NET and mCRPC indications, including ongoing and future discussions with the FDA and related future updates; Exelixis’ anticipated timing of 2024 for the next analysis of OS from CONTACT-02; 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. |
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CONDENSED CONSOLIDATED STATEMENTS OF INCOME |
||||||||||||||||
(in thousands, except per share amounts) |
||||||||||||||||
(unaudited) |
||||||||||||||||
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|
|
|
|
||||||||||||
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|
Three Months Ended
|
|
Year Ended
|
||||||||||||
|
|
2023 |
|
2022 |
|
2023 |
|
2022 |
||||||||
Revenues: |
|
|
|
|
|
|
|
|||||||||
Net product revenues |
$ |
429,336 |
|
|
$ |
377,419 |
|
|
$ |
1,628,879 |
|
|
$ |
1,401,243 |
|
|
License revenues |
|
45,229 |
|
|
|
38,079 |
|
|
|
178,635 |
|
|
|
162,056 |
|
|
Collaboration services revenues |
|
5,087 |
|
|
|
8,419 |
|
|
|
22,694 |
|
|
|
47,763 |
|
|
Total revenues |
|
479,652 |
|
|
|
423,917 |
|
|
|
1,830,208 |
|
|
|
1,611,062 |
|
|
Operating expenses: |
|
|
|
|
|
|
|
|||||||||
Cost of goods sold |
|
21,753 |
|
|
|
15,920 |
|
|
|
72,547 |
|
|
|
57,909 |
|
|
Research and development |
|
244,670 |
|
|
|
336,824 |
|
|
|
1,044,071 |
|
|
|
891,813 |
|
|
Selling, general and administrative |
|
131,441 |
|
|
|
119,251 |
|
|
|
542,705 |
|
|
|
459,856 |
|
|
Total operating expenses |
|
397,864 |
|
|
|
471,995 |
|
|
|
1,659,323 |
|
|
|
1,409,578 |
|
|
Income (loss) from operations |
|
81,788 |
|
|
|
(48,078 |
) |
|
|
170,885 |
|
|
|
201,484 |
|
|
Interest income |
|
21,388 |
|
|
|
16,988 |
|
|
|
86,543 |
|
|
|
33,065 |
|
|
Other income (expense), net |
|
(137 |
) |
|
|
(337 |
) |
|
|
93 |
|
|
|
(197 |
) |
|
Income (loss) before income taxes |
|
103,039 |
|
|
|
(31,427 |
) |
|
|
257,521 |
|
|
|
234,352 |
|
|
Provision for (benefit from) income taxes |
|
17,521 |
|
|
|
(1,254 |
) |
|
|
49,756 |
|
|
|
52,070 |
|
|
Net income (loss) |
$ |
85,518 |
|
|
$ |
(30,173 |
) |
|
$ |
207,765 |
|
|
$ |
182,282 |
|
|
Net income (loss) per share: |
|
|
|
|
|
|
|
|||||||||
Basic |
$ |
0.28 |
|
|
$ |
(0.09 |
) |
|
$ |
0.65 |
|
|
$ |
0.57 |
|
|
Diluted |
$ |
0.27 |
|
|
$ |
(0.09 |
) |
|
$ |
0.65 |
|
|
$ |
0.56 |
|
|
Weighted-average common shares outstanding: |
|
|
|
|
|
|
|
|||||||||
Basic |
|
308,482 |
|
|
|
323,256 |
|
|
|
318,151 |
|
|
|
321,526 |
|
|
Diluted (1) |
|
313,023 |
|
|
|
323,256 |
|
|
|
321,464 |
|
|
|
324,556 |
|
|
| ____________________ | ||
(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. |
|
EXELIXIS, INC. |
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RECONCILIATION OF GAAP NET INCOME TO NON-GAAP NET INCOME |
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(in thousands, except per share amounts) |
||||||||||||||||
(unaudited) |
||||||||||||||||
|
|
|
|
|
||||||||||||
|
|
Three Months Ended
|
|
Year Ended
|
||||||||||||
|
|
2023 |
|
2022 |
|
2023 |
|
2022 |
||||||||
GAAP net income (loss) |
$ |
85,518 |
|
|
$ |
(30,173 |
) |
|
$ |
207,765 |
|
|
$ |
182,282 |
|
|
Adjustments: |
|
|
|
|
|
|
|
|||||||||
Stock-based compensation - research and development expenses (1) |
|
9,041 |
|
|
|
10,464 |
|
|
|
34,320 |
|
|
|
45,350 |
|
|
Stock-based compensation - selling, general and administrative expenses (1) |
|
15,265 |
|
|
|
15,392 |
|
|
|
72,025 |
|
|
|
62,224 |
|
|
Income tax effect of the above adjustments |
|
(5,629 |
) |
|
|
(5,897 |
) |
|
|
(24,691 |
) |
|
|
(24,411 |
) |
|
Non-GAAP net income (loss) |
$ |
104,195 |
|
|
$ |
(10,214 |
) |
|
$ |
289,419 |
|
|
$ |
265,445 |
|
|
GAAP net income (loss) per share: |
|
|
|
|
|
|
|
|||||||||
Basic |
$ |
0.28 |
|
|
$ |
(0.09 |
) |
|
$ |
0.65 |
|
|
$ |
0.57 |
|
|
Diluted (2) |
$ |
0.27 |
|
|
$ |
(0.09 |
) |
|
$ |
0.65 |
|
|
$ |
0.56 |
|
|
Non-GAAP net income (loss) per share: |
|
|
|
|
|
|
|
|||||||||
Basic |
$ |
0.34 |
|
|
$ |
(0.03 |
) |
|
$ |
0.91 |
|
|
$ |
0.83 |
|
|
Diluted |
$ |
0.33 |
|
|
$ |
(0.03 |
) |
|
$ |
0.90 |
|
|
$ |
0.82 |
|
|
Weighted-average common shares outstanding: |
|
|
|
|
|
|
|
|||||||||
Basic |
|
308,482 |
|
|
|
323,256 |
|
|
|
318,151 |
|
|
|
321,526 |
|
|
Diluted (2) |
|
313,023 |
|
|
|
323,256 |
|
|
|
321,464 |
|
|
|
324,556 |
|
|
| ____________________ | ||
(1) |
Non-cash stock-based compensation expense used for GAAP reporting in accordance with Accounting Standards Codification Topic 718, Compensation—Stock Compensation. |
|
(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/
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.
FAQ
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